BR122025008593A2 - Devices and methods for precise dose delivery. - Google Patents

Abstract

"DEVICES AND METHODS FOR PRECISE DOSE DELIVERY" This refers to devices and methods for delivering a predetermined volume of a pharmaceutical substance or other product that includes a fluid. An exemplary device may include a body configured to receive a pharmaceutical substance therein, and a plunger rod disposed at least partially inside the body to distally move a stop in the body. The device may include a component configured to regulate the distal movement of the plunger rod in a priming step and in a subsequent delivery step, so that the device can be correctly primed and can correctly dispense a predetermined volume of a pharmaceutical substance.

Description

Cross-reference to related orders

[0001] This application claims priority for Provisional Application No. U.S. 62/857,678, filed June 5, 2019, and Provisional Application No. U.S. 62/860,481, filed June 12, 2019, each of which is incorporated by reference herein in its entirety.

Field of Revelation

[0002] Aspects of the present disclosure relate to devices and methods for priming or otherwise configuring a dose delivery device, for example, a syringe, to promote precise dose delivery. More specifically, embodiments of the present disclosure relate to devices and methods for loading, storing, transporting and/or delivering precise doses of a pharmaceutical substance or other fluid substance.

Introduction

[0003] Pharmaceutical products, including fluid pharmaceutical substances, can be delivered to patients in a variety of ways, including by injection. In many cases, the precision and accuracy of the volume of a pharmaceutical product is crucial. For example, medical professionals may have an interest in ensuring that an approved or prescribed volume of a pharmaceutical substance is consistently delivered to each patient who needs the drug. Furthermore, even a slight overdose or underdosing of a pharmaceutical substance in a patient can have an undesirable (or even negative) clinical impact on the patient. Additionally, some pharmaceutical products are prescribed in low volumes (e.g., below 100 μl). At low volumes, human error in priming and delivering an accurate dose of a pharmaceutical substance for injection can affect the drug's effectiveness in a patient and the subsequent clinical effect on the patient.

[0004] Additional aspects of fluid drug delivery can complicate the goal of precise dose delivery by injection. For example, for a correct dose of a pharmacological substance to be dispensed from a device (e.g., a syringe), an exact corresponding volume of the substance must be loaded into the device. Furthermore, the handling, storage, packaging, and/or transport of loaded devices must not result in the inadvertent expulsion of the pharmacological substance from the devices. Additionally, prior to administering a pharmacological substance from a device, it may be necessary to prime the device, for example, to remove air bubbles and excess pharmacological substance from within the needle and barrel of the device. Incorrect priming of a device can result in the expulsion of an excessive or insufficient amount of pharmacological substance from the device, which can also result in delivering a reduced dose to a patient or injecting air bubbles from the device into the patient.

[0005] This disclosure also addresses unmet needs addressed by previous publications WO2018/232408, published December 20, 2018; WO2018/224640, published December 13, 2018; and WO2018/224644, published December 13, 2018. Furthermore, at least some embodiments of this disclosure include features that are different from those disclosed in publication WO2019/118588, published June 20, 2019. Some features include, for example, a piston rod including one or more extensions extending distally from an actuating portion of the piston rod and having hook- or clip-shaped receiving parts with lateral openings of a flanged portion. The piston rod may include a neck with three or more sections, each with a different cross-sectional profile and/or shape relative to the others. Other features may include, for example, a flange portion including a collar having one or more internal grooves to receive the hook or clip-shaped portions of one or more extensions, thus allowing the extensions to flex radially outward from a compressed configuration to an expanded configuration. The flange portion may include an opening configured to receive each of the three or more neck sections based, for example, on a rotational arrangement of the piston rod relative to the flange portion.

[0006] A flange portion of the present disclosure may additionally include one or more movable ribs and/or one or more movable tabs for engaging a syringe body to couple the flange portion to the syringe body. For example, one or more movable ribs may be positioned proximal to a protrusion and side opening of the flange portion to receive an upper flange of the syringe body. The movable ribs may move, deflect, and/or deform in response to receiving the upper flange through the side opening and may be configured to apply a distally directed force to the upper flange to secure the syringe body to the flange portion. By way of further example, one or more movable tabs may be positioned distal to the protrusion and side opening. The movable tabs may move, deflect, and/or deform in response to the flange portion receiving the syringe body and may be configured to apply a radially directed force to the syringe body to secure the syringe body to the flange portion. It should be understood that the modalities of the present disclosure include several other features shown and described in this document that are different from those disclosed in publication WO2019/118588.

Summary

[0007] Drug delivery devices are disclosed in this document. In one embodiment of the present disclosure, a drug delivery device includes a body, a plunger rod disposed partially within the body, a protrusion extending from the plunger rod, and a locking component in the body. When the protrusion is in a first position relative to the locking component, the locking component restricts the distal movement of the plunger rod to a first stopping point, and when the protrusion is in a second position relative to the locking component, the locking component restricts the distal movement of the plunger rod to a second stopping point.

[0008] In some aspects of the present disclosure, the drug delivery device additionally includes a stop disposed in the body. Distal movement of the plunger rod distally moves the cap and a pharmacological substance disposed in the body between the cap and a distal end of the body. Distal movement of the plunger rod relative to the first stop point primes the drug delivery device and distal movement of the plunger rod relative to the second stop point dispenses a predetermined volume of the pharmacological substance from a distal end of the device.

[0009] In some aspects of the present disclosure, moving the protrusion from the first position to the second position involves twisting the plunger rod relative to the locking component. In some aspects of the present disclosure, the drug delivery device additionally includes a cavity on a proximal side of the locking component, the cavity being sized and configured to receive a portion of the protrusion. When the protrusion is in the second position relative to the locking component, the protrusion is positioned proximally from the cavity, so that distal movement of the plunger rod moves the protrusion into the cavity.

[0010] In some aspects of the present disclosure, the cavity is a first cavity and the drug delivery device additionally includes a second cavity on a proximal side of the locking component, the second cavity being sized and configured to receive a portion of the protrusion. The first and second cavities are located on opposite sides of a central longitudinal geometric axis of the drug delivery device. In some aspects of the present disclosure, the locking component includes a flange and is coupled to a proximal end portion of the body and the plunger rod passes through an opening in the locking component. In some aspects of the present disclosure, the drug delivery device additionally includes an actuating portion on a proximal end portion of the plunger rod and the protrusion extends from the actuating portion.

[0011] In some aspects of the present disclosure, the actuating portion includes a generally cylindrical shape that has a diameter greater than the width of the remainder of the plunger rod. The protrusion extends from one side of the generally cylindrical shape, and the actuating portion further includes a thumb pad at a proximal end of the actuating portion and a ring on an outer surface on the side of the generally cylindrical shape. In some aspects of the present disclosure, the drug delivery device further includes a proximal collar on the locking component, and the actuating portion partially fits within the proximal collar.

[0012] In some aspects of the present disclosure, the plunger rod additionally includes a pair of extensions that project distally from the actuating portion, and the locking component includes a pair of openings. A portion of each extension is configured to be received by one of the pair of openings at the first stopping point. In some aspects of the present disclosure, the locking component includes one or more recesses formed along a lower wall of the locking component. A portion of each extension is configured to be received by one or more recesses after distal movement of the plunger rod relative to the locking component to allow distal movement of the plunger rod relative to the second stopping point.

[0013] In some aspects of the present disclosure, the locking component includes a pair of internal grooves formed along a side wall of the locking component. A portion of each extension is configured to be received by at least one of the pair of internal grooves after rotation of the plunger rod relative to the locking component to expand the extensions radially outward from a compressed to a relaxed state. In some aspects of the present disclosure, the protrusion is a first protrusion and the drug delivery device additionally includes a second protrusion extending from the plunger rod in a direction opposite to the first protrusion. In some aspects of the present disclosure, the locking component is slidably coupled to the body and includes a pair of internal ribs that are configured to engage an upper flange of the body when the body is slidably coupled to the locking component. The pair of internal ribs is configured to apply a distally directed force on the upper flange.

[0014] In some aspects of the present disclosure, the locking component is slidingly coupled to the body and includes a pair of movable tabs that are configured to engage a body sleeve when the body is slidingly coupled to the locking component. The pair of movable tabs is laterally deflectable after receiving the sleeve on the locking component and is configured to apply a radially directed force on the sleeve. In some aspects of the present disclosure, the locking component additionally includes a pair of finger flanges. Each of the finger flanges includes a textured surface with a predefined pattern that increases the grip of the locking component.

[0015] According to another embodiment of the present disclosure, a drug delivery device includes a body, a plunger rod having a distal end coupled to a stop within the body and a proximal end including an actuating portion with a thumb pad, a plurality of protrusions extending from the actuating portion, and a locking component disposed in the body, wherein the locking component includes a proximal collar. When the protrusions and the locking component are in a first configuration, the locking component restricts the distal movement of the plunger rod to a first stopping point, and when the protrusions and the locking component are in a second configuration, the locking component restricts the distal movement of the plunger rod to a second stopping point. The proximal collar is configured to receive the protrusions upon distal movement of the plunger rod when the protrusions are in the second configuration.

[0016] In some aspects of the present disclosure, the protrusions and the locking component are movable from the first configuration to the second configuration by rotation of the actuating portion about a longitudinal geometric axis relative to the locking component. In some aspects of the present disclosure, a difference between the first stop point and the second stop point is equivalent to a distance that the stop must travel to expel a predetermined volume of a pharmaceutical product from a distal end of the body. In some aspects of the present disclosure, the plurality of protrusions includes two protrusions arranged symmetrically around the actuating portion. In some aspects of the present disclosure, the locking component additionally includes a pair of finger flanges. In some aspects of the present disclosure, the drug delivery device is a pre-filled syringe.

[0017] In some aspects of the present disclosure, the drug delivery device is changeable: (a) from a pre-use state to a primed state by moving the plunger rod longitudinally until the plunger rod reaches the first stop point; (b) from the primed state to a delivery state by rotating the plunger rod relative to the locking component until the protrusions and the locking component are in the second configuration; and (c) from a delivery state to a used state by moving the plunger rod longitudinally until the plunger reaches the second stop point. In some aspects of the present disclosure, the plunger rod includes a neck disposed distally from the actuating portion and the neck interfaces with an opening in the locking component to prevent proximal movement of the plunger rod. In some aspects of the present disclosure, the bottleneck additionally interfaces with the opening in the locking component to prevent movement of the drug delivery device from the delivery state to the primed state.

[0018] In another embodiment of the present disclosure, a drug delivery device includes a body, a plunger rod comprising: a distal portion coupled to a stop within the body; a proximal end comprising a generally cylindrical actuating portion disposed outside the body; and two protrusions extending from opposite sides of the actuating portion in a symmetrical configuration. The drug delivery device further includes a locking component coupled to the body, wherein the locking component includes a collar configured to accept a distal portion of the actuating portion and two cavities in the collar having proximally facing openings. Each cavity is configured to accept a distal portion of one of the two protrusions. The plunger rod is longitudinally movable and rotatable about a longitudinal geometric axis relative to the locking component. When the drug delivery device is in a pre-use state, the protrusions and cavity openings are not longitudinally aligned, and when the drug delivery device is in a delivery state, the protrusions and cavity openings are longitudinally aligned. In some aspects of the present disclosure, the locking component additionally includes a finger flange and the drug delivery device additionally comprises a ribbed surface on one side of the actuating portion.

[0019] In another embodiment of the present disclosure, a method is disclosed for dispensing a substance from a drug delivery device that has a plunger rod and a body. The method includes advancing the plunger rod a predetermined distance into the body until the plunger rod's advance is resisted by a stop, rotating the plunger rod about a longitudinal geometric axis, and actuating the plunger rod to dispense a predetermined volume of the substance.

[0020] In some aspects of the present disclosure, the piston rod advance and the piston rod actuation include pressing an actuating portion of the piston rod. In some aspects of the present disclosure, the piston rod includes a protrusion, the stop includes a locking component coupled to the body, and the locking component abuts the protrusion to resist the piston rod advance.

[0021] In some aspects of the present disclosure, rotating the piston rod includes twisting an actuating portion of the piston rod relative to a locking component of the piston rod until a protrusion on the piston rod becomes longitudinally aligned with a cavity in the locking component. In some aspects of the present disclosure, actuating the piston rod includes pressing the actuating portion of the piston rod to advance the protrusion into the cavity.

[0022] In some aspects of the present disclosure, the method further includes advancing the protrusion into the cavity until the protrusion abuts a distal side of the cavity and the predetermined volume of the substance is dispensed when the protrusion abuts the distal side of the cavity.

[0023] In another embodiment of the present disclosure, a drug delivery device includes a body, a stop disposed within the body, and a sleeve having a proximal end and a distal end. The distal end is disposed within the body, proximal to the stop. The device includes a plunger rod disposed at least partially within the sleeve. When the stop is in a primed position, distal advancement of one of (a) only the sleeve, (b) only the plunger rod, or (c) both the sleeve and the plunger rod together, relative to the body, advances the stop to a primed position. When the stop is in the primed position, distal advancement of another of (a) only the sleeve, (b) only the plunger rod, or (c) both the sleeve and the plunger rod together, relative to the body, advances the stop to a dose-finish position.

[0024] In some aspects of the present disclosure, the drug delivery device further includes a removable locking component disposed between a proximal portion of the glove and a proximal end of the body. The locking component obstructs the distal advancement of the glove relative to the body. The distal advancement of the glove relative to the body after removal of the locking component advances the stop to the primed position. The locking component is a clip removablely attached around at least one portion of the glove.

[0025] In some aspects of the present disclosure, the drug delivery device additionally includes a removable locking component that couples the plunger rod to the sleeve. Distal advancement of both the sleeve and the plunger rod together, relative to the body, advances the stop to the primed position. Distal advancement of only the plunger rod relative to the body after removal of the locking component advances the stop to the dose-termination position. In the dose-termination position, a proximal end of the plunger rod abuts a distal end of the sleeve, so that the plunger rod is prevented from advancing distally relative to the body. The removable locking component includes a pin, a tab, or a bar.

[0026] In some aspects of the present disclosure, the drug delivery device further includes a protrusion disposed on the plunger rod and an internal protrusion disposed on an inner wall of the glove distal to the plunger rod protrusion. Distal advancement of the plunger rod only relative to the body advances the stop to the primed position and causes the plunger rod protrusion to contact the inner glove protrusion. Distal advancement of both the plunger rod and the glove relative to the body, after the plunger rod protrusion has contacted the inner glove protrusion, advances the stop to the dose termination position.

[0027] In some aspects of the present disclosure, a compressible protrusion on the plunger rod and an opening disposed in an inner wall of the sleeve, proximal to the protrusion on the plunger rod. Distal advancement of the plunger rod only relative to the body advances the cap to the primed position. Proximal withdrawal of the plunger rod until the compressible protrusion of the plunger rod enters the opening of the sleeve couples the sleeve to the plunger rod. Distal advancement of the coupled plunger rod and sleeve relative to the body advances the stop to the dose termination position. In some aspects of the present disclosure, when the sleeve is coupled to the plunger rod, a total length of the sleeve and plunger rod combined along a proximal-distal geometric axis is greater than a length of the plunger rod alone.

[0028] In some aspects of the present disclosure, the glove includes a finger flange. In some aspects of the present disclosure, the drug delivery device additionally includes a stop disposed at a proximal end of the body. The stop is sized to block distal advancement of the glove or plunger rod once the stop is in the termination position.

[0029] In other embodiments of the present disclosure, a drug delivery device includes a body and a plunger rod that has a distal portion disposed within the body and a proximal portion disposed outside a proximal end of the body. The proximal portion has a greater width than the width of the distal portion. The device further includes an obstruction that, in an obstructive position relative to the plunger rod, prevents distal advancement of the plunger rod from a primed position to a dose-termination position. Displacement of the obstruction from the obstructive position allows distal advancement of the plunger rod to the dose-termination position.

[0030] In some aspects of the present disclosure, the drug delivery device further includes a collar affixed to a proximal end portion of the body. The collar encircles the proximal portion of the plunger rod. The drug delivery device further includes a collar projection that extends radially inward from the collar. The proximal portion of the plunger rod includes a channel into which the collar projection projects, wherein the channel includes a circumferential path and an axial dose termination path. The obstruction comprises the collar projection, which, when disposed in the circumferential path of the channel, prevents distal advancement of the plunger rod to the dose termination position. Displacement of the obstruction from the obstructing position comprises rotating the plunger rod around a longitudinal geometric axis to align the collar projection with the axial dose termination path.

[0031] In some aspects of the present disclosure, the channel additionally includes an axial priming path offset from the axial dose termination path and connected to the axial dose termination path by the circumferential path. The distal movement of the plunger rod is such that the collar projection that moves in the axial priming path advances the plunger rod to the primed position. In some aspects of the present disclosure, the collar additionally comprises a finger flange.

[0032] In some aspects of the present disclosure, the proximal portion of the plunger rod includes a projection that extends radially outward. The drug delivery device further includes a rotary alignment component disposed between the proximal portion of the plunger rod and the body. The alignment component includes a channel, the channel sized and configured to accommodate the plunger rod projection. The obstruction comprises a channel wall that blocks a distal axial path of the plunger rod projection when the plunger rod is in the primed position. Displacing the obstruction from the obstructing position comprises rotating the alignment component to remove the channel wall from the distal axial path of the plunger rod projection.

[0033] In some aspects of the present disclosure, the drug delivery device further includes a finger flange coupled to a proximal end portion of the body. The rotary alignment component is disposed between the finger flange and the proximal portion of the plunger rod. In some aspects of the present disclosure, the drug delivery device further includes a flange portion disposed at the proximal end of the body. The obstruction includes a removable cap which, when in the obstructing position relative to the plunger rod, is partially disposed between the proximal portion of the plunger rod and the flange portion. In some aspects of the present disclosure, removal of the cap allows the proximal portion of the plunger rod to advance to a dose termination position. In the dose termination position, the proximal portion of the plunger rod contacts the flange portion. In some aspects of the present disclosure, the removable cap covers the proximal portion of the plunger rod when in the obstructing position.

[0034] In some aspects of the present disclosure, the drug delivery device further includes a collar disposed between the proximal end of the body and the proximal portion of the plunger rod. The collar defines an opening sized to accommodate the proximal portion of the plunger rod after distal advancement of the plunger rod beyond a primed position. The obstruction comprises a tab that projects radially outward from the proximal portion of the plunger rod, the tab preventing the proximal portion of the plunger rod from fitting into the collar opening. A depth of the collar opening coincides with a distance the plunger rod must travel to advance distally to the dose termination position.

[0035] In some aspects of the present disclosure, displacing the obstruction from the obstructing position comprises removing the flap or compressing the flap on one side of the proximal portion of the plunger rod. In some aspects of the present disclosure, the flap is a first flap and the obstruction further comprises a second flap projecting radially outward from the proximal portion of the plunger rod in a direction opposite to the direction of protrusion of the first flap. In some aspects of the present disclosure, the obstruction comprises a flap that, when in the obstructing position, is disposed between the body and the proximal portion of the plunger rod. The plunger rod includes a geometry disposed proximally from the flap, and the geometry cannot extend distally beyond the flap when the flap is in the obstructing position.

[0036] In some aspects of the present disclosure, displacing the obstruction comprises removing the tab from the drug delivery device by pulling the tab. In some aspects of the present disclosure, the drug delivery device further includes a flange portion, wherein a portion of the tab is disposed within a cavity of the flange portion. In some aspects of the present disclosure, displacing the obstruction comprises removing the tab from the drug delivery device by breaking the tab.

[0037] In some aspects of the present disclosure, the obstruction includes a flange portion which, in the obstructing position, is disposed proximally to the proximal end of the body, between the proximal portion of the plunger rod and the body, and is spaced from the proximal end of the body by a removable blocking component. Displacement of the obstruction from the obstructing position includes removal of the blocking component and displacement of the flange portion distally toward the proximal end of the body.

[0038] In some aspects of the present disclosure, the plunger rod includes a projection that extends radially outward. The obstruction includes a lever with one end that, in the obstructing position, is located distally from the projection and blocks the distal movement of the projection and thus the distal movement of the plunger rod. Displacing the obstruction from the obstructing position comprises actuating the lever to remove the end of the lever from its distal location from the projection. In some aspects of the present disclosure, distal advancement of the plunger rod beyond the dose termination position is prevented by contact between the proximal portion of the plunger rod and a portion of a flanged part coupled to the body.

[0039] In other embodiments of the present disclosure, a drug delivery device includes a body and a sleeve attached to the body. The sleeve includes a proximal end, a distal end, and an opening disposed in a circumferential wall of the sleeve. The drug delivery device further includes a plunger rod that passes through the sleeve, the plunger rod including a distal end portion disposed within the body and a radially extending protrusion. The plunger rod can be distally advanced in the body from a ready position to a primed position. In the primed position, the protrusion of the plunger rod is disposed within the opening, and further distal advancement of the plunger rod is resisted by contact between the protrusion and a wall of the opening. Pressure can be exerted on the protrusion to overcome the resistance to further distal advancement of the plunger rod.

[0040] In some aspects of the present disclosure, the opening in the glove is a second opening and the glove further includes a first opening disposed in the circumferential wall of the glove proximally from the second opening and a third opening disposed in the circumferential wall of the glove distally from the second opening. In the primed position, the plunger rod protrusion is disposed in the first opening and further distal advancement of the plunger rod is resisted by contact between the protrusion and a wall of the first opening. After further distal advancement of the plunger rod beyond the primed position, the plunger rod protrusion is disposed in the third opening and further distal advancement of the plunger rod is prevented.

[0041] In some aspects of the present disclosure, the radially extending protrusion is a first protrusion, and the plunger rod additionally includes a second radially extending protrusion opposite to the first protrusion. Pressing the first and second protrusions toward each other while applying axial pressure in the distal direction to the plunger rod overcomes the resistance to further distal advancement of the plunger rod. In some aspects of the present disclosure, a proximal end of the sleeve includes an enlarged opening. Distal advancement of the plunger rod from the ready position to the primed position includes advancement of the protrusion into the enlarged opening and through the sleeve, whereby the protrusion is compressed between an interior of the sleeve and the plunger rod until the protrusion extends into the opening disposed in the circumferential wall of the sleeve. In some aspects of the present disclosure, the protrusion includes a distally tapering profile to assist in the distal advancement of the plunger rod.

[0042] In other embodiments of the present disclosure, a drug delivery device includes a body, a plunger rod including a distal end portion disposed within the body and a rotating element, and a sleeve attached to the body, the sleeve including a proximal opening into which the plunger rod can be advanced. Rotation of the rotating element causes distal advancement of the plunger rod to a primed position. Once the plunger rod is in the primed position, further rotation of the rotating element is resisted.

[0043] In some aspects of the present disclosure, the rotating element includes a cam lever. Once the plunger rod is in the primed position, the plunger rod can be pressed into the body to advance the plunger rod distally to a dose-termination position. In some aspects of the present disclosure, the drug delivery device further includes a collar disposed at a proximal end of the body, an interior of the collar including a proximal threaded portion forming a proximal helical path. The rotating element comprises a proximal portion of the plunger rod including a protrusion. The proximal portion of the plunger rod can be rotated about a longitudinal geometric axis to cause the protrusion to move distally along the proximal helical path. Once the protrusion reaches the end of the proximal threaded portion of the collar, the plunger rod is in the primed position.

[0044] In some aspects of the present disclosure, once the plunger rod is in the primed position, the plunger rod can be axially pressed into the body to advance the plunger rod distally to a dose-termination position. In some aspects of the present disclosure, the interior of the collar additionally includes a distal threaded portion. The threads of the distal threaded portion form a distal helical path offset from and opposite to the proximal helical path. Alignment of the protrusion with the distal helical path places the plunger rod in the primed position. Rotation of the proximal portion of the plunger rod that causes the protrusion to move distally along the distal helical path causes distal advancement of the plunger rod to a dose-termination position.

[0045] In other embodiments of the present disclosure, a drug delivery device includes a body, a stop disposed within the body, and a first plunger rod having a first proximal end portion and a first distal end portion narrower than the first proximal end portion. The first distal end portion having a first length. The drug delivery device further includes a second plunger rod having a second proximal end portion and a second distal end portion narrower than the proximal end portion. The second distal end portion has a second length. The drug delivery device further includes a finger flange affixed to a proximal end portion of the body. The finger flange having a through hole aligned with a proximal opening of the body. The through hole sized to accommodate each of the first and second distal end portions without accommodating either of the first or second proximal end portions. Advancing the first distal end portion through the passage hole until the first proximal end portion abuts the finger flange pushes the stop distally into a primed position. Advancing the second distal end portion through the passage hole until the second proximal end portion abuts the finger flange pushes the stop distally into a dose termination position.

[0046] In other embodiments of the present disclosure, a method of assembling a drug delivery device includes coupling a body to a locking component, wherein the locking component is a flanged part, and coupling a plunger rod to the locking component such that the plunger rod is disposed partially within the body in a pre-assembled state and inhibited from proximal movement relative to the locking component. In the pre-assembled state, the plunger rod is configured to move distally relative to the locking component to a first stopping point with a protrusion of the plunger rod engaging the locking component, causing a priming dose of a drug to be expelled from the body. When the protrusion is engaged with the locking component, the locking component is configured to restrict the distal movement of the plunger rod to a first stopping point. The plunger rod is further configured so that, while the plunger rod is at the first stopping point, it rotates relative to the locking component to disengage the protrusion from the locking component and moves distally relative to the locking component to a second stopping point with the protrusion engaging the locking component, causing a delivery dose of a drug to be expelled from the body.

[0047] In some aspects of the present disclosure, the method further includes inserting a top flange of the body into an opening of the locking component, causing a tab of the locking component to deviate radially outward and a rib of the locking component to deviate proximally. The tab applies a radially inward force to the body and the rib applies a distal force to the top flange to secure the body to the locking component. The method further includes inserting a plunger rod extension into a side opening of the locking component to secure the plunger rod to the locking component in the pre-assembled state. The plunger rod is configured to deviate the extension radially inward in response to the movement of the plunger rod distally relative to the locking component to the first stopping point, so that the extension is removed from the side opening. The extension is configured to move against an interior of the locking component when the plunger rod rotates relative to the locking component to align the protrusion with a slot in the locking component. The extension flexes radially outward within the locking component when the protrusion is aligned with the slot. The extension is configured to extend into a recess along the inside of the locking component when the plunger rod moves distally to the second stopping point.

Brief Description of the Drawings

[0048] The accompanying drawings, which are incorporated into and form part of this descriptive report, illustrate various exemplary embodiments and, together with the description, serve to explain the principles of the embodiments disclosed. The drawings show different aspects of the present disclosure and, where appropriate, reference numerals illustrating similar structures, components, materials and/or elements in different figures are similarly labeled. It is understood that various combinations of structures, components and/or elements in various embodiments, in addition to those specifically shown, are contemplated and encompassed within the scope of the present disclosure.

[0049] There are many embodiments described and illustrated in this document. The devices and methods described are not limited to any single aspect or embodiment thereof, nor to any combinations and/or permutations of such aspects and/or embodiments. Furthermore, each of the aspects of the inventions described, and/or embodiments thereof, may be employed alone or in combination with one or more of the other aspects of the inventions described and/or embodiments thereof. For the sake of brevity, certain permutations and combinations are not discussed and/or illustrated separately in this document.

[0050] Figures 1A-1E depict an exemplary delivery device and components thereof, according to some embodiments of the present disclosure.

[0051] Figures 1F-2T depict additional aspects and modalities of the exemplary delivery device of Figures 1A-1E.

[0052] Figures 3A and 3B depict an exemplary method of assembling the delivery device depicted in Figures 1A-1E, according to aspects of the present disclosure.

[0053] Figures 3C-3F depict an exemplary method of assembling an embodiment of the delivery device depicted in Figures 1A-1E, according to aspects of the present disclosure.

[0054] Figures 4A-4F depict an exemplary method of using the delivery device depicted in Figures 1A-1E, in accordance with aspects of the present disclosure.

[0055] Figures 4G-4J depict an exemplary method of using an embodiment of the delivery device depicted in Figures 1A-1E, in accordance with aspects of the present disclosure.

[0056] Figures 4K-4S depict exemplary aspects of piston rods for use in embodiments of the delivery device depicted in Figures 1A-1E.

[0057] Figures 4T-4X depict views of an exemplary neck portion of a piston rod and opening of a flange portion in embodiments of the delivery device depicted in Figures 1A-1E.

[0058] Figures 4Y-4Z depict exemplary aspects of piston rods for use in embodiments of the delivery device depicted in Figures 1A-1E.

[0059] Figures 5A-5C depict another exemplary delivery device according to further embodiments of the present disclosure.

[0060] Figures 6A-6E depict another exemplary delivery device according to additional embodiments of the present disclosure.

[0061] Figures 7A-7F depict an exemplary method of using the delivery device depicted in Figures 6A-6E, in accordance with aspects of the present disclosure.

[0062] Figures 8A-8E depict another exemplary delivery device according to embodiments of the present disclosure.

[0063] Figures 8F and 8G depict a locking component of the delivery device depicted in Figures 8A-8E according to embodiments of the present disclosure.

[0064] Figures 9A-9E depict an exemplary method of using the delivery device depicted in Figures 8A-8E, in accordance with aspects of the present disclosure.

[0065] Figures 10A-10C depict an exemplary method of assembling the delivery device depicted in Figures 8A-8E, according to aspects of the present disclosure.

[0066] Figures 10D-10G depict another exemplary method of assembling a variation of the delivery device depicted in Figures 8A-8E, according to aspects of the present disclosure.

[0067] Figures 11A-11E depict an exemplary method of using the delivery device depicted in Figures 10D-10G in accordance with aspects of the present disclosure.

[0068] Figures 12A-12D depict a close-up view of aspects of the exemplary method depicted in Figures 11A-11E.

[0069] Figures 13A and 13B depict another exemplary delivery device and method of assembling said delivery device, according to further embodiments of the present disclosure.

[0070] Figures 14A-14F depict a method for using the delivery device depicted in Figures 12A and 12B.

[0071] Figures 15A-15B and 16A-16B depict exemplary piston rod dials according to other embodiments of the present disclosure.

[0072] Figure 17 represents an exemplary piston rod and dial according to other embodiments of the present disclosure.

[0073] Figures 18A and 18B depict an additional exemplary piston rod and dial according to further embodiments of the present disclosure.

[0074] Figures 19A and 19B depict an exemplary rotation locking mechanism according to further embodiments of the present disclosure.

[0075] Figure 20 represents an example of a piston rod fitting feature according to further embodiments of the present disclosure.

[0076] Figure 21 represents an exemplary piston rod with a protrusion feature according to further embodiments of the present disclosure.

[0077] Figure 22 represents examples of visual feedback resources according to some modalities of the present disclosure.

[0078] Figures 23A-23C depict another exemplary delivery device according to aspects of the present disclosure.

[0079] Figures 24A-24E depict another exemplary delivery device and method for using said delivery device, in accordance with aspects of the present disclosure.

[0080] Figures 25A-25E depict another exemplary delivery device and method for using said delivery device, according to aspects of the present disclosure.

[0081] Figures 26A-26G depict other exemplary delivery devices and a method of using such a delivery device, according to aspects of the present disclosure.

[0082] Figures 27A-27H depict another exemplary delivery device and method for using said delivery device, in accordance with aspects of the present disclosure.

[0083] Figures 28A-28Z depict other exemplary delivery devices and methods of use of said delivery devices, in accordance with aspects of the present disclosure.

[0084] Figures 29A-29C depict another exemplary delivery device and method for using said delivery device, according to aspects of the present disclosure.

[0085] Figures 30-31 depict another exemplary delivery device and method of using said delivery device, in accordance with aspects of the present disclosure.

[0086] Figures 32-33 depict another exemplary delivery device and method for using said delivery device, in accordance with aspects of the present disclosure.

[0087] Figures 34-40C depict another exemplary delivery device and method of using said delivery device, according to aspects of the present disclosure.

[0088] Figures 41A-41D depict exemplary flange parts according to other embodiments of the present disclosure.

[0089] There are many embodiments described and illustrated in this document. This disclosure is not limited to any aspect or embodiment thereof, nor to any combinations and/or permutations of such aspects and/or embodiments. Each aspect of this disclosure, and/or embodiment thereof, may be employed alone or in combination with one or more of the other aspects of this disclosure and/or embodiments thereof. For the sake of brevity, many of these combinations and permutations are not discussed separately in this document.

Detailed description

[0090] The features of this disclosure may be used in addition to and/or in combination with aspects of International Application No. PCT/US2018/065192, filed on December 12, 2018, which is incorporated by reference in its entirety herein.

[0091] As used in this document, the terms "comprises," "comprising," "includes," "including," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus comprising a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. The term "exemplificative" is used in the sense of "example," rather than "ideal." Notably, an embodiment or implementation described in this document as an "example" or "exemplificative" should not be interpreted as preferential or advantageous, for example, in relation to other embodiments or implementations; rather, it is intended to reflect or indicate that the embodiment(s) is/are an "example," rather than an "ideal." Furthermore, the terms "first," "second," and similar terms in this document do not denote any order, quantity, or importance, but instead are used to distinguish one element, structure, step, or process from another. Additionally, the terms "a" and "an" in this document do not denote a limitation of quantity, but rather denote the presence of one or more of the referenced items. Furthermore, the terms "about," "approximately," "substantially," and similar terms, when used in the description of a numerical value, denote a variation of +/- 10% of that value, unless otherwise specified.

[0092] The embodiments of the present disclosure may be used with any type of fluid-containing products, such as liquid pharmaceutical substances, liquid placebos, or other liquids that can be dispensed in a dosage format. As used herein, the term "pharmaceutical substance" may refer to a formulated substance including an active ingredient or ingredients, such as, for example, small or large molecules, such as pain medications, steroids, or biological products. As used herein, the term "biological" may refer to a large molecule (e.g., having a size greater than 15 kDa, greater than 30 kDa, greater than 50 kDa, greater than 75 kDa, or greater than 100 kDa) created in a living system such as a cell. Biological products may include proteins (e.g., antibodies), nucleic acids, large sugars, etc. Unlike small molecules that may have well-defined chemical structures, biological products may have highly complex structures that cannot be easily quantified by laboratory methods. As used in this document, the term "pharmaceutical product" may refer to a volume of a pharmaceutical substance distributed in a primary packaging component for packaging, transport, delivery and/or administration to a patient.

[0093] The term "primary packaging component" refers to a packaging component for a pharmaceutical product, such as a drug container, that is designed and manufactured to be in direct physical contact with the formulated pharmaceutical substance. (See, for example, Guidance for Industry on Container Closure Systems for Packaging Human and Biologic Drugs, U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, and Center for Biologics Evaluation and Research (May 1999), which is incorporated by reference herein.) Examples of primary packaging components include pre-filled syringes, Luer syringes, cartridges, and vials made of glass, plastic, other polymers or copolymers, and/or other materials.

[0094] As used in this document, the terms "distal" and "distally" refer to a location (or portion of a device) relatively closer to, or in the direction of, a patient delivery site, and the terms "proximal" and "proximal" refer to a location (or portion of a device) relatively closer to, or in the direction of, a user extremity opposite a distal location/portion of a device.

[0095] As used in this document, the term “body,” when used in reference to a part of a device, may refer to a component of the device suitable for containing a volume of a pharmacological substance. A body may include, for example, a cylinder (such as a syringe barrel), tubing, barrel, or other containment portion of a device. In some embodiments, a body may also include a distal end portion with a tip, needle, needle attachment point, and/or distal cap.

[0096] The embodiments of the present disclosure can be used with products that typically have small dose volumes, such as, for example, ophthalmic pharmaceutical products. In some embodiments, the devices of the present disclosure can be used with pharmaceutical products including a large molecule, for example, a molecular weight of 30 kDa or higher. In some embodiments, the devices of the present disclosure can be used with pharmaceutical products including a fragment of a large molecule. For example, in some embodiments, the devices of the present disclosure can be used with pharmaceutical products including an antigen-binding molecule. In some respects, the antigen-binding molecule may be an antibody or an antigen-binding fragment. In some embodiments, the devices of the present disclosure may be suitable for use with pharmaceutical products, including ingredients such as, for example, aflibercept, alirocumab, pegol abicipar, bevacizumab, brolucizumab, conbercept, dupilumab, evolocumab, tocilizumab, certolizumab, abatacept, rituximab, inflimabix, ranibizumab, sarilumab, adalimumab, anakinra, trastuzumab, pegfilgrastim, interferon beta-1a, insulin glargine [rDNA origin], epoetin alfa, darbepoetin, filigrastim, golimumab, etanercept, antigen-binding fragments of any of the above, or combinations of any of the foregoing, binding domains, such as a bispecific antibody to VEGF or angiopoietin-2, among others.

[0097] In some embodiments, the devices and aspects of the present disclosure may be used with any therapies for ophthalmic diseases, including for the treatment of patients with diabetic eye disease, post-injection non-infectious endophthalmitis, neovascular (wet) age-related macular degeneration (AMD), macular edema after retinal vein occlusion (RVO), diabetic macular edema (DME), and diabetic retinopathy (DR). In particular, large molecule and small molecule antagonists of VEGF and/or ANG-2, such as aflibercept, ranibizumab, bevacizumab, conbercept, OPT-302, RTH258 (brolocizumab), pegol abicipar (a pegylated engineered ankyrin repeat protein (DARPin)), RG7716, or fragments thereof and at any concentration. Intravitreal (IVT) administration of therapeutic agents can be an effective treatment for such ocular diseases (e.g., macular degeneration, retinal vein occlusion, macular edema, retinopathy, etc.); however, IVT administration involves several challenges, such as pharmacological product development, administration procedure, and adverse events. For example, providing precise and accurate delivery of small volumes (10-100 μl) requires precise design of the container components. Consequently, inaccuracies in dosage delivery (e.g., overdosing or underdosing) can lead to undesirable adverse events or lack of efficacy, resulting in unpredictable and variable clinical responses.

[0098] In some embodiments, the devices and aspects of the present disclosure may provide precise dose delivery while providing a container closure system to maintain the agent in a sterile, stable, and safe condition to increase the intended shelf life and efficacy of the agent. IVT pharmaceutical products are primarily presented in glass vials; however, pre-filled syringes offer more convenient administration by reducing the number of steps required for dose preparation. Pre-assembly of the agent in the devices of the present disclosure may minimize the steps required to prepare a dose for delivery to a patient. Product development studies may focus on characterization of the primary container component, material compatibility with the formulation, formulation stability, determination of fill volume, extractable/leachable, and terminal sterilization.

[0099] In addition, careful selection of auxiliary components, such as disposable syringes and needles, and a detailed administration procedure that includes dosage instructions can ensure successful administration of the product. Despite significant efforts to improve the pharmaceutical product and administration procedures, ocular safety issues such as endophthalmitis, increased intraocular pressure, and the presence of silicone floaters have been reported. Devices and aspects of the present disclosure can provide detailed administration procedures (e.g., priming instructions, dosage instructions, etc.) to ensure successful administration of the agent to a patient to minimize such ocular safety concerns. In some embodiments, the devices and aspects of the present disclosure can also be used for cosmetic or medical dermatology applications, such as the treatment or diagnosis of allergic responses.

[0100] In some embodiments, the devices and aspects of the present disclosure can be used to perform various injection procedures in the eye, such as, for example, intraocular treatments and surgeries involving an intravitreal injection of a pharmacological product. Devices and aspects of the present disclosure can be used to dispense pharmaceutical products of varying protein concentration and/or viscosity, including, for example, pharmaceutical products with viscosities ranging from about 0.001 pascal-second (1 centipoise) to about 0.01 pascal-second (10 centipoise), from about 0.002 pascal-second (2 centipoise) to about 0.009 pascal-second (9 centipoise), from about 0.003 pascal-second (3 centipoise) to about 0.008 pascal-second (8 centipoise), from about 0.004 pascal-second (4 centipoise) to about 0.007 pascal-second (7 centipoise), or from about 0.005 pascal-second (5 centipoise) to about 0.006 pascal-second (6 centipoise). (centipoise). Pharmaceutical products with other viscosities are also contemplated. Delivering a precise dose with a device of the present disclosure can be important given the potential variability in protein concentration or viscosity of a pharmaceutical product being delivered to a patient. Devices and aspects of the present disclosure can also be used to dispense various volumes and/or quantities of a pharmaceutical product, such as volumes ranging from about 1 μl to about 200 μl, from about 10 μl to about 190 μl, from about 50 μl to about 150 μl, from about 75 μl to about 125 μl, from about 90 μl to about 110 μl, or about 100 μl. The devices of the present disclosure can be configured and operated to require the application of a minimum force exceeding a limit to perform one or more procedures, such as priming a device, delivering a dose, and the like. By requiring the application of minimum force, the devices of the present disclosure can promote control in administering a consistent dose of a pharmaceutical product and promote safety by minimizing inadvertent movement of device components, thus potentially reducing pain, discomfort, and injury to a patient.

[0101] For some products in particular, for example, ophthalmic products or other pharmaceutical products, dose accuracy may be particularly important. However, it is also contemplated that the embodiments of the present disclosure may be applicable to any other liquid products or any other context for which precise methods for defining and administering a reliable and accurate dose or delivery volume are beneficial.

[0102] In some embodiments, the devices according to the present disclosure may be manufactured, packaged, filled and/or prepared in accordance with processes relevant to the products (e.g., pharmaceutical products) of which they may be a part. For example, in some embodiments, the devices according to the present disclosure may be sterilized before or after being filled and/or packaged. For example, in some embodiments, the devices according to the present disclosure may be filled and packaged in, for example, blister packaging and/or may be terminally sterilized using any suitable method in the art. For example, the devices according to the present disclosure may be terminally sterilized using a chemical sterilization method, such as a method including ethylene oxide or hydrogen peroxide (e.g., vaporized hydrogen peroxide). In some embodiments, the devices according to the present disclosure can be terminally sterilized using methods described, for example, in International Application No. PCT/US2018/021013, filed on March 6, 2018, which is incorporated by reference herein in its entirety.

[0103] Commercially available dose delivery devices, such as pre-filled syringes or syringes for use with vials, may not necessarily assist in accurately loading a desired volume of a substance, priming the devices, expelling an excessive volume of pharmacological substance from the devices, and/or removing air bubbles from the devices. In dose delivery devices containing a small volume of a particular pharmacological substance (e.g., approximately 500 μl or less, approximately 300 μl or less, approximately 250 μl or less, approximately 200 μl or less, approximately 150 μl or less, approximately 100 μl or less, approximately 50 μl or less, or approximately 25 μl or less, such as between approximately 25 μl and approximately 50 μl, between approximately 50 μl and approximately 100 μl, between approximately 25 μl and approximately 100 μl, between approximately 50 μl and approximately 150 μl, between approximately 100 μl and approximately 250 μl, between approximately 100 μl and approximately 150 μl, between approximately 150 μl and approximately 250 μl, between approximately 200 μl and approximately 250 μl, between approximately 200 μl and approximately 500 μl, or between approximately 250 μl and approximately 500 μl), it can also be difficult to confirm the presence of the correct dose of a pharmacological substance in the device with the naked eye. Currently, in the market for dose delivery devices, and specifically in the syringe market, there is a need for mechanisms that allow the user to precisely set a small volume of a product to be delivered in a syringe (e.g., a pre-filled or refillable syringe), prime the syringe, remove air bubbles from the syringe, and/or confirm or be certain that the dose volume in the syringe is correct. The embodiments of this disclosure may assist manufacturers, suppliers of pharmaceutical products, medical professionals, and/or patients in producing, filling, or otherwise priming a dose delivery device, preparing the device, removing bubbles from the device, confirming the dose, and/or administering a dose from the device to a patient. Furthermore, the embodiments of this disclosure may assist in preventing or mitigating errors or variations in the manufacture or use of the device, such as errors or variations in the placement of dosing lines on devices, variations in device geometry (e.g., variations in syringe neck geometry), variations in component manufacturing tolerances, and/or variations or errors in defining a dosing line prior to product delivery.

[0104] In some cases, the modalities of the present disclosure may be of particular help to individuals who may have difficulty in establishing doses accurately and precisely. For example, the modalities of the present disclosure may help elderly individuals, young children, or people with physical or mental disabilities in establishing accurate doses.

[0105] Several embodiments of dose delivery devices, and in particular syringes, are described in this document. In some cases, embodiments or aspects of embodiments disclosed in this document may be used in conjunction with existing syringe body parts to modify ready-to-use products, which may reduce the development and manufacturing time of dose delivery devices. In other cases, embodiments or aspects of embodiments disclosed in this document may be incorporated into devices during their manufacture. The syringes described in this document may be pre-filled or may be refillable/fillable.

[0106] The embodiments of the present disclosure may include syringes with rotating parts, threaded parts, springs, gears, detents, channels, grooves and the like, which may allow a user to precisely control the movement of priming and dosing delivery elements, such as plungers and/or stops. These parts may be intended to reduce human error and/or increase accuracy.

[0107] In some embodiments, visualization devices, such as magnifying glasses, may be provided with, attached to, or otherwise arranged on delivery devices in order to help improve the visibility of dose measurement markers on the devices. It is contemplated that aspects of one embodiment (such as gloves, channels, locking components, protrusions, holders, threaded parts, grips, visual, tactile, or auditory indicators, etc.) may be combined with aspects of one or more other embodiments to create various combinations and permutations of features in a single device.

[0108] In some embodiments, the devices according to the present disclosure may be described as including a type of plunger rod and plunger, or including a general schematic representation of a plunger rod and plunger. For example, some devices according to the present disclosure may be depicted or described as including, for example, a plunger rod with a spherical tip end, which engages with a stop so that the plunger rod and the stop can be fixed together. It is contemplated that multiple and/or different configurations of plunger rods and stops may be appropriate for each of the embodiments disclosed herein. For example, in some cases, the aforementioned spherical tip plunger rod may be used with embodiments disclosed herein. In some embodiments, a plunger rod may not be fixed to a stop and instead may be disposed near, beside, or flush against a stop so that pressure from the plunger rod toward the stop may push the stop, but withdrawal, twisting, or other movement of the plunger rod may not cause the cover to be pulled off, twisted, or otherwise moved. As another example, in some embodiments, a plunger rod may be fixed to a stop by threads, a clip, or an adhesive, or it may be a single piece with a stop (for example, it may have been manufactured in a single mold with a stop).

[0109] In some embodiments, the devices according to the present disclosure may include various cosmetic features relevant to the intended users of the devices. For example, the devices according to the present disclosure may be manufactured and sold for use with pediatric, elderly, or disabled patients. In such cases, the devices according to the present disclosure may include child-friendly colors, cartoon images, or other cosmetic features to appeal to children, or high-contrast colors, textured surfaces, or other features to enhance ease of identification and/or use. In some cases, the devices according to the present disclosure may include lettering, labeling, or other features designed to be easily recognized by the intended users. For example, the lettering on a pediatric device or a device for use by a disabled or impaired person or an elderly person may have larger and more accessible labels so that they can be more easily recognized and read by the user(s) of the device. In some embodiments, the lettering or labels may be raised, molded, or embossed.

[0110] Referring now to Figures 1A-1E, views of a 1050 delivery device and component parts are depicted. The device 1050 includes a body 1060 and a locking component in the form of a flange portion 1070 with a proximal collar 1072 around an opening 1073 (shown, for example, in Figures 3B-3E), through which a plunger rod 1080 can pass into the body 1060. The plunger rod 1080 includes an actuating portion 1082 that can be actuated (e.g., pushed or twisted) to rotate the plunger rod 1080 or to move the plunger rod 1080 longitudinally into the body 1060. The actuating portion 1082 can be sized and configured to fit (e.g., nest or otherwise engage) within the proximal collar 1072.

[0111] The device 1050 may be, for example, an injection device, such as a syringe, for dispensing a predetermined volume of a formulated pharmaceutical substance. In some embodiments, the device 1050 may be a pre-filled syringe. For example, a user may receive an assembled and packaged device 1050 ready for use, with a volume of formulated pharmaceutical substance already disposed between a stop 1062 in the body 1060 and an expulsion end 1064 of the body 1060. In some embodiments, an air bubble (not shown) may also be disposed between the stop 1062 and the expulsion end 1064. In other embodiments, the device 1050 may be a fillable syringe.

[0112] The body 1060 may be any suitable body configured to retain and expel a predetermined volume of a formulated pharmacological substance. In some embodiments, the body 1060 may have, for example, a hollow cylindrical portion. The body 1060 may be configured to contain any suitable volume of a formulated pharmacological substance for delivery to, for example, a patient, and (together with other components of the device 1050) to expel a predetermined amount of the retained volume through, for example, the expulsion end 1064 in a priming and/or delivery step. In some embodiments, the 1060 body can be configured to retain and (together with other components of the 1050 device) expel a relatively small volume of formulated pharmacological substance (e.g., less than about 100 μl, such as less than about 80 μl, less than about 60 μl, less than about 40 μl, less than about 20 μl, less than about 10 μl, about 95 μl, about 90 μl, about 85 μl, about 80 μl, about 75 μl, about 70 μl, about 65 μl, about 60 μl, about 55 μl, about 50 μl, about 45 μl, about 40 μl, approximately 35 μl, approximately 30 μl, approximately 25 μl, approximately 20 μl, approximately 15 μl, approximately 10 μl, or approximately 5 μl). The device 1050, along with its other components, can be further configured to minimize a residual volume of the formulated pharmacological substance remaining in the body 1060 after delivery of the predetermined small volume to the patient. In some embodiments, the body 1060 can be pre-filled (e.g., before complete assembly, packaging, sterilization, and/or shipment of the device 1050 to users). In some embodiments, the stop 1062 can be configured to contain a predetermined volume of a formulated pharmacological substance within a cavity of the body 1060.

[0113] The flange portion 1070 may be of any size and/or shape suitable for serving as a locking component in the delivery device 1050, for closing, partially closing, covering, or partially covering one end of the body 1060 opposite the ejection end 1064, and/or for supporting and holding the plunger rod 1080 in place within the body 1060. In some embodiments, the flange portion 1070 may include a distal collar 1075 configured to engage with the body 1060 and hold the flange portion 1070 in place relative to the body 1060. For example, the distal collar 1075 may include a shoulder 1071 that may slide down or otherwise relative to a body flange 1061, to hold the flange portion 1070 in place (e.g., to slide the flange portion 1070 to the body 1061). (body 1060). In alternative embodiments, the protrusion 1071 of the distal collar 1075 may be made of a flexible or semi-flexible material, so that it can fit into place over the flange of the body 1061. In other embodiments, the distal collar 1075 or another portion of the flange part 1070 may be adhered, molded, or otherwise affixed to the body 1060 or may engage with the body 1060 by means of a friction fitting.

[0114] The flanged part 1070 may be or include a locking component; that is, part or all of the flanged part 1070 may be dimensioned and configured to control the movement of the piston rod 1080 by blocking the movement of the piston rod 1080 when the piston rod 1080 is in certain configurations relative to the flanged part 1070. For example, the flanged part 1070 may be configured to control the rotational and longitudinal movement of the piston rod 1080, for example, through the opening 1073 (see, for example, Figures 3B-3E) which complements the size and shape of the piston rod parts 1080 (for example, neck 1084 and actuating portion 1082 and/or other portions of the piston rod 1080 as shown in Figures 3I and 3M). As described in more detail in this document, the flanged part 1070 can be formed from various materials with a minimum strength and/or stiffness that can provide additional control of a rotational or longitudinal movement of the piston rod 1080. For example, the flanged part 1070 can be configured to resist the proximal movement (or "pull-back") of the piston rod 1080 (e.g., to inhibit disassembly of the device 1050 by retracting the piston rod 1080) up to a predetermined force based at least in part on a material composition of the flanged part 1070. It should be understood that the flanged part 1070 can be configured such that the application of a force exceeding the predetermined force can cause one or more of the flanged parts 1070 and piston rod 1080 to break, thus rendering the device 1050 inoperable.

[0115] By way of further example, the flanged part 1070 may be configured to resist the rotational movement of the plunger rod 1080 (e.g., to inhibit inadvertent rotation) up to a predetermined force based at least in part on a material composition of the flanged part 1070. Additionally and/or alternatively, the flanged part 1070 may be configured to resist the distal movement of the plunger rod 1080 to control a dosage delivery rate (e.g., to inhibit inadvertent delivery) based at least in part on a material composition of the flanged part 1070. Several other components of the device 1050 besides the flanged part 1070 may include a material composition that provides a frictional interference to inhibit disassembly of the device 1050, inadvertent rotation of the plunger rod 1080 and/or inadvertent dosage delivery.

[0116] The proximal collar 1072 of the flange portion 1070 can be dimensioned and configured to accept part of the actuating portion 1082 of the piston rod 1080, while blocking the protrusions 1086 of the piston rod 1080 from moving distally past a predetermined point until the piston rod 1080 is rotated to a particular position. As shown in Figures 1A and 1B, the collar 1072 can be cylindrical; in alternative embodiments, the collar 1072 can have any suitable size or shape compatible with the actuating portion 1082. The collar 1072 can also include cavities, for example, slots 1074 in which the protrusions 1086 of the piston rod 1080 can be received. Slots 1074 may have proximally facing openings and may have a depth dimension parallel to a longitudinal geometric axis of the device 1050. A number and configuration of slots 1074 may correspond to a number and configuration of protrusions 1086 on the plunger rod 1080. In some embodiments, slots 1074 may be arranged around a perimeter of the collar 1072 in a radially symmetrical configuration. In other embodiments, the collar 1072 may include only one slit 1074. The depth of the slits 1074 may correspond to a distance that the plunger rod 1080 must move in order to push the stop 1062 toward the ejection end 1064 and dispense a predetermined volume of the formulated pharmaceutical substance from the body 1060 to the ejection end 1064. Advantageously, the predetermined volume of the formulated pharmaceutical substance to be dispensed from the body 1060 can be controlled during manufacture, for example, by selecting a particular depth of slits 1074. In some embodiments, the device 1050 may be configured so that normal variations in the manufacture of other parts of the device 1050 (e.g., body 1060 or plunger rod 1080) may not cause variations in the volume of the formulated pharmaceutical substance to be dispensed from the body 1060. As such, the predetermined volume can be controlled simply by varying the manufacturing of the 1070 flange part.

[0117] In some embodiments, the flange portion 1070 may include one or more flanges 1076, which may be sized and configured to assist a user in holding the device 1050 and/or expelling a formulated pharmacological substance from the device 1050. In some embodiments, as depicted in Figures 1A-1E, the flange portion 1070 may include two flanges 1076 opposing each other and extending perpendicularly from a longitudinal dimension of the device 1050. In some embodiments, the flange portion 1070 may include other arrangements of a flange or flanges, such as four flanges or a circumferential flange extending radially outward from a central longitudinal geometric axis of the device 1050. In some embodiments, the flange portion 1070 may extend radially outward from a central longitudinal geometric axis of the device 1050 beyond a circumference of the body 1060. In such In embodiments, the flanged part 1070 can support the device 1050 if the device 1050 is placed on a surface, can prevent the device 1050 from rolling on a flat surface, and/or can allow the device 1050 to be picked up more easily. In still other embodiments, the locking component aspects of the flanged part 1070 (e.g., collar 1072) can be separated from the flanged part 1070, so that the delivery device 1050 includes a separate flanged part and a locking component.

[0118] The piston rod 1080 can generally be rotatable about a central longitudinal geometric axis (e.g., in one direction or in both directions). In some embodiments, the rotation of the piston rod 1080 can be achieved by gripping and/or twisting the actuating portion 1082 relative to the flanged part 1070 and/or body 1060. In some embodiments, the protrusions 1086 can assist a user in gripping and/or twisting the actuating portion 1082 relative to the flanged part 1070 and/or body 1060, providing additional surface area that a user can grip and/or push to twist the actuating portion 1082. In some embodiments, only a part or parts of the piston rod 1080 (e.g., actuating portion 1082 and/or a neck 1084) may be rotatable relative to the flanged part 1070 and/or body 1060. In some embodiments, the piston rod 1080 may be configured to rotate relative to the flanged part 1070 in response to the application of a predetermined torsional force on the actuating portion 1082. A material composition of the flanged part 1070 may be determinant of the predetermined torsional force required to rotate the piston rod 1080 relative to the flanged part 1070. For example, the flanged part 1070 may be formed of various materials with a predetermined stiffness that may generate frictional resistance against the piston rod 1080 to control the rotational movement of the piston rod 1080 up to the force predetermined (e.g., to inhibit inadvertent rotation/accidental twisting of the piston rod 1080). In addition, a material composition of the flange portion 1070 may provide a friction tolerance to control distal translation of the piston rod 1080 up to a predetermined force (e.g., to inhibit inadvertent delivery of dosage by the device 1050).

[0119] A rod 1081 of the piston rod 1080 may have any thickness and cross-sectional shape suitable for fitting into the body 1060 while maintaining robustness. For example, in some embodiments, the rod 1081 may have such a large thickness, along at least one dimension, as it can fit and slide into the body 1060. Advantageously, such thickness may help in preventing unwanted oscillations of the piston rod 1080 relative to the other components of the device 1050. In other embodiments, the rod 1081 may have a smaller thickness, while still maintaining robustness (e.g., it does not bend, break, or warp during assembly and/or use of the device 1050). In some embodiments, portions of the rod 1081 may be configured to allow the piston rod 1080 to rotate relative to the flange portion 1070, while other portions of the rod 1081 may not (see, for example, Figures 3I-3Q).

[0120] The plunger rod 1080 may also include a distal tip 1083 (see, for example, Figure 1D) sized and configured to push, attach, or otherwise interface with the stop 1062. The tip 1083 may be of any size or shape suitable for achieving this purpose. In some embodiments, for example, tip 1083 may be sized and configured to attach to stop 1062 through an opening in stop 1062. In other embodiments, tip 1083 may have a ball shape configured to fit into an opening in stop 1062. In still other embodiments, tip 1083 may have a flat surface parallel to a proximal surface of stop 1062 and may be configured to push stop 1062 distally without securing stop 1062. In other embodiments, tip 1083 may have any molded surface suitable for pushing stop 1062 distally.

[0121] In some embodiments, the neck 1084 of the piston rod 1080 and the opening 1073 of the flange portion 1070 may have complementary geometries that restrict the extent and direction that the piston rod 1080 (or a portion thereof) can rotate, depending on the specific longitudinal and/or rotational position of the piston rod 1080 relative to the flange portion 1070. In some embodiments, the actuating portion 1082 of the piston rod 1080 and the collar 1072 may also include complementary geometries that control the extent and direction that the piston rod 1080 can move relative to the flange portion 1070. For example, the rotation and/or longitudinal movement of the piston rod 1080 may be restricted based on the priming, priming, and/or drug delivery steps of a method for Use the device 1050 (see, for example, the method described in relation to Figures 3A-3F and the additional/alternative method described in relation to Figures 3G and 3H), and the corresponding position of the plunger rod 1080 in relation to each step in these methods. For example, the plunger rod 1080 can be prevented from being moved out of the flange part 1070 in a proximal direction (e.g., falling out or being pulled out) once the device 1050 is assembled. Furthermore, the plunger rod 1080 can be restrained from rotating about a longitudinal geometric axis before the device 1050 is in a "primed" state and/or after the device 1050 is in a "delivery" state. Furthermore, the longitudinal movement of the piston rod 1080 in the proximal direction (e.g., to "retract" the piston rod 1080) can be restricted after the device 1050 is in a "primed" and/or "delivered" state by complementary geometries of the neck 1084 of the piston rod 1080 and opening 1073 of the flange portion 1070 and/or the actuating portion 1082 of the piston rod 1080 and collar 1072 of the flange portion 1070. Advantageously, this can prevent unwanted piston rod retraction in cases where the piston rod 1080 is not held within the body 1060, for example, being fixed to the stop 1062. For example, in some embodiments, the piston rod 1080 can be configured to simply make contact or rest against the stop 1062, so that the proximal movement of the piston rod 1080 does not move the stop 1062 proximally. In such cases, the proximal movement of the piston rod 1080 can be prevented by the interaction between the complementary geometries of the piston rod 1080 and the flange portion 1070. Furthermore, the interaction between the actuating portion 1082 of the piston rod 1080 and the collar 1072 of the flange portion 1070 can restrict the longitudinal movement of the piston rod 1080 in a distal direction. For example, the piston rod 1080 can be prevented from moving distally after the "primed" state, but before the "delivered" state.

[0122] When moved to the "delivery" state, the protrusions 1086 in the actuating portion 1082 can be longitudinally aligned with the slots 1074 of the collar 1072, allowing distal movement of the plunger rod 1080 to dispense a desired volume of a pharmacological substance from the body 1060. As such, the plunger rod 1080 may include a number and configuration of protrusions 1086 such that each protrusion 1086 can move distally to a slot 1074 when the plunger rod 1080 is in a particular position (e.g., a "delivery" state). In some embodiments, one, two, three, or more protrusions 1086 may extend from the actuating portion 1082, corresponding to one, two, three, or more slots 1074, respectively. For example, as depicted, two protrusions 1086 may extend from the sides of the actuating portion 1082 in a radially symmetrical configuration (corresponding to two slots 1074 in the collar 1072). In some embodiments, the radial symmetry of multiple protrusions 1086 (and slots 1074) may advantageously allow the protrusions 1086 to fit into the slots 1074 in multiple configurations (e.g., depending on whether the actuating portion 1082 is twisted in one direction or another). In such embodiments, the actuating portion 1082 may be twisted in any direction based, for example, on user preference, right-handedness or left-handedness, or other factors. In some embodiments, the plunger rod 1080 may not be pulled proximally or retracted out of the body 1060 (e.g., towards the actuating portion 1082) after the plunger rod 1080 is in a "primed" state and/or after a desired volume of the formulated pharmacological substance has been delivered from the device 1050 by depression of the plunger rod 1080 in the body 1060 (e.g., due to a neck geometry 1084 and/or opening 1073).

[0123] In some embodiments, the 1050 device may be configured for ease of use and may include one or more features that assist a user by providing tactile or visual feedback. For example, one, two, or more components of the 1050 device may have contrasting colors or textures. In some embodiments, for example, the flange part 1070 may have a different coloration from the plunger rod 1080. As another example, a single component of the 1050 device may have two or more colors or textures. In some embodiments, for example, the actuation portion 1082 may include a first color on a distal part of the actuation portion 1082, which becomes covered by the collar 1072 when the device 1050 is primed, and a second color on a second portion of the actuation portion 1082, which moves adjacent to the collar 1072 when the device 1050 is primed, to help indicate to a user that the device 1050 has been properly primed. As another example, in some embodiments, the flange portion 1070 may have a different tactile feel than the plunger rod 1080 and/or body 1060. For example, the flange portion 1070 may be relatively rougher or smoother than the plunger rod 1080 and/or body 1060. As yet another example, one or more components of the device 1050 may have textures that aid in holding, gripping, identifying, or using the device 1050. For example, the flange portion 1070 may have a slightly rough or raised texture to help a user grip the flanges 1076 and/or to prevent a user's fingers from slipping off the flanges 1076 during use. In some embodiments, part or all of the flange portion 1070 may have a smooth-touch surface. As another example, the actuating portion 1082 of the piston rod 1080 may include a rough or raised texture to aid in gripping and rotating the piston rod 1080. For example, as depicted in Figures 1A-1I, 2A, 2B, and 3A-3H, the actuating portion 1082 may include circumferential ribs on its side(s). The actuating portion 1082 may have any suitable number of ribs on its side(s) to provide texture. In other embodiments, the actuating portion 1082 may not have ribs on its side(s).

[0124] In some embodiments, the device 1050 or one or more of its components may include colors, labels, or markers, which may indicate contents or a status of the device 1050 and/or which may direct or provide instructions to a user of the device 1050. Examples include one or more labels to indicate a priming position versus a dosing delivery position of the plunger rod, one or more labels to indicate directions in which to rotate or move the plunger rod 1080, and/or one or more labels to indicate an amount of the formulated pharmacological substance included in the device 1050 (e.g., linear markings on the body 1060). Labels can, for example, be glued or printed onto components of the 1050 device, or they can be engraved onto, or molded as part of, components of the 1050 device. In some embodiments, one or more textured labels (e.g., engraved or molded onto the 1050 device) may also serve as a textured, rough, or raised surface to assist a user in gripping or using the 1050 device. One or more exemplary labels may include words, numbers, indicators, and/or symbols (e.g., lines, padlocks, arrows, diagrams, etc.).

[0125] In some embodiments, the device 1050 may be configured to make one or more sounds during its use. For example, the device 1050 may make a "click" noise after completion of a priming step or after rotation of the plunger rod to a position suitable for dispensing a predetermined volume of a formulated pharmaceutical substance. A "click" noise may be produced by, for example, friction between two or more components (e.g., plunger rod 1080 and flange part 1070), or a portion of one component in contact with another portion (e.g., neck 1084 of the plunger rod 1080 in contact with the opening 1073 of the flange part 1070). In some embodiments, the device 1050 may include one or more detents or protrusions on adjacent surfaces of, for example, plunger rod 1080 and flange part 1070, which may produce a clicking sound upon contact with each other (for example, wings 1089 on neck 1084 in contact with detents 1078 around opening 1073, as shown in Figures 3R-3V). These sounds may serve as auditory feedback to indicate that a user has reached a specific step in the use of the device 1050.

[0126] In some embodiments, the device 1050 may include additional features or components to control the movement of the piston rod 1080 relative to the body 1060. For example, as shown in Figure 1F, the flange portion 1070 may include an opening 1079 through which a pin 1077 may be disposed. Pin 1077 can be sized and configured to interface with the actuating portion 1082 of the piston rod 1080 (e.g., to slide into an opening (not shown) in the actuating portion 1082), so that when pin 1077 is inserted to engage the actuating portion 1082, the piston rod 1080 cannot be moved proximally or distally relative to the body 1060 and flange portion 1070. In some embodiments, pin 1077 can also prevent rotational movement of the piston rod 1080 relative to the flange portion 1070. Pin 1077 can be inserted during the filling and assembly of a device (e.g., the device 1050 shown in Figures 1A and 1B) to prevent unwanted movement of the piston rod 1080 before its use. In some embodiments, pin 1077 may remain inserted during packaging, transport, and delivery of device 1050. Before use of device 1050, pin 1077 may be removed or otherwise positioned so that it does not engage with the actuating portion 1082.

[0127] As shown in Figures 1G and 1H, in some embodiments, a protrusion 1093 may be disposed on a distal portion of the actuating portion 1082, which may be located within the flanged part 1070 after assembly of the device 1050. An internal shoulder 1091 of the flanged part 1070 may project over the protrusion 1093, such that the actuating portion 1082 cannot be pulled proximally out of the flanged part 1070. In some embodiments, either protrusion 1093, shoulder 1091, or both may be disposed circumferentially around the actuating portion 1082, such that the shoulder 1091 blocks the protrusion 1093, regardless of a rotational position of the actuating portion 1082 relative to the flanged part 1070. The protrusion 1093 and the shoulder 1091 may have square cross-sectional profiles, as shown in Figure 1G, angled cross-sectional profiles, as shown in Figure 1H, or any other suitable cross-sectional profiles. In some embodiments, a cross-sectional profile of the protrusion 1093, shoulder 1091, or both may be selected to improve ease of manufacture (e.g., machining or molding the shape of the protrusion 1093 or shoulder 1091) or may be selected to improve assembly (e.g., insertion of the piston rod 1080 into and partially through the flange portion 1070).

[0128] As shown in Figure 1I, in some embodiments, the actuating portion 1082 may include one or more projections 1096 extending radially outward from an outer perimeter of protrusion 1093. For example, protrusion 1093 may include a pair of projections 1096 arranged on protrusion 1093 at opposite locations. The projections 1096 may include various sizes, shapes, and/or suitable cross-sectional profiles. In some embodiments, the projections 1096 may have a circular shape with a rounded outer profile to facilitate movement of protrusion 1093 within the flange portion 1070.

[0129] In the present example, the projections 1096 may be positioned along a side of the protrusion 1093 that is longitudinally aligned with a corresponding side of the actuating portion 1082 including the protrusions 1086. In other examples, the projections 1096 may be positioned along a side of the protrusion 1093 that is offset (e.g., not in longitudinal alignment) with the side of the actuating portion 1093 including protrusions 1086. The projections 1096 may be formed of various flexible materials, including, for example, a polymer such as plastic, rubber, etc. It should be understood that the plunger rod 1080 may include additional and/or fewer projections 1096 on the protrusion 1093, or other portions of the actuating portion 1082, than those shown and described in the present document, without departing from the scope of this disclosure.

[0130] Figure 1J represents a distal end portion of flange part 1070 including one or more recesses 1097 along an inner surface. The recesses 1097 can be dimensioned and shaped to receive projections 1096 when the protrusion 1093 is received within the flange portion 1070 and positioned adjacent to and/or in contact with the edge 1091. It should be understood that the projection 1091 can be configured to require the application of a hydrodynamic force on the piston rod 1080 to receive projections 1096 and protrusion 1093 distally from the projection 1091 and into the flange portion 1070, thus priming the device 1050 and inhibiting retraction (e.g., proximal movement) of the piston rod 1080 relative to the flange portion 1070. It should be understood that by inhibiting the removal of the piston rod 1080 after initial assembly into the flange portion 1070, the device 1050 can be configured to prevent reuse. of the device 1050 after initial use and/or to prevent the formation of inadvertent air bubbles from entering the device 1050. In the present example, the flange portion 1070 may include a plurality of recesses 1097 arranged around the distal end portion in an annular array relative to each other. The plurality of recesses 1097 may be spaced from each other around a circumference of the flange portion 1070. In some embodiments, the flange portion 1070 may include recesses 1097 with various sizes and/or shapes relative to each other.

[0131] As described in more detail below, a subset of the plurality of recesses 1097 can be dimensioned and shaped to receive and allow the passage of projections 1096 through it by means of the movement of the protrusion 1093 relative to the flange part 1070. A second subset of the plurality of recesses 1097 can be dimensioned and shaped to receive and inhibit the passage of projections 1096 through it, so that the protrusion 1093 is restricted from further movement relative to the flange part 1070, as explained in more detail below.

[0132] For example, as shown in Figure 1K, flange portion 1070 includes a pair of enlarged recesses 1097a positioned around opening 1073 (with piston rod 1080 received through it) at opposite locations relative to each other (e.g., spaced about 180 degrees from each other). Flange portion 1070 further includes a pair of narrow recesses 1097b positioned around opening 1073 at opposite locations relative to each other (e.g., about 180 degrees from each other). A recess 1097a may be positioned approximately 90 degrees from an adjacent recess 1097b, along the circumference of the flange portion 1070. Enlarged recesses 1097a may include a transverse (e.g., perpendicular) central wall to a longitudinal length of flanges 1076 and side walls that are angled relative to the central wall. Narrow recesses 1097b may include a central wall parallel to the longitudinal length of flanges 1076 and side walls that are perpendicular to the central wall. It should be understood that enlarged recesses 1097a may form a larger opening to receive projections 1096 relative to narrow recesses 1097b. It should further be understood that the side walls of recesses 1097a, 1097b may have a height that is parallel to a longitudinal length of the device 1050.

[0133] In a first configuration seen in Figure 1K, the piston rod 1080 is received through the flange part 1070 and the protrusion 1093 is oriented relative to the opening 1073 so that the projections 1096 are received within enlarged recesses 1097a. The angled side walls of the enlarged recesses 1097a may provide clearance to facilitate the movement of the projections 1096 out of the enlarged recesses 1097a in response to a rotation of the piston rod 1080 relative to the flange part 1070. In this case, the projections 1096 may move along the angled side walls of the enlarged recesses 1097a as the protrusion 1093 rotates relative to the opening 1073.

[0134] As seen in Figure 1L, the projections 1096 can abut the inner surface of the flange part 1070 that defines the opening 1073 as the protrusion 1093 rotates. The projections 1096 can generate frictional interference against the flange part 1070 while moving between the adjacent recesses 1097. Figure 1M shows the protrusion 1093 positioned relative to the opening 1073 with projections 1096 aligned and received in narrow recesses 1097b. In this case, the piston rod 1080 can be configured to generate audible and/or tactile feedback in response to narrow recesses 1097b receiving projections 1096. For example, a "click" or "popping" noise can be generated in response to a pressure release applied to the projections 1096 by the inner surface of the flange part 1070 when the projections 1096 are received in narrow recesses 1097b. Additionally and/or alternatively, audible feedback can be produced in response to the projections 1096 expanding and striking one or more walls defining narrow recesses 1097b when received therein.

[0135] It should be understood that a frictional interference between the projections 1096 and the flange part 1070 can be removed after receiving the projections 1096 within narrow recesses 1097b. The side walls of the narrow recesses 1097b can provide a physical restraint that inhibits further movement of the projections 1096. In this case, the piston rod 1080 can be fixed relative to the flange part 1070 so that the protrusion 1093 is inhibited from further rotation relative to the opening 1073 when the projections 1096 are received within narrow recesses 1097b.

[0136] As shown in Figures 1N-1P, in some embodiments, the piston rod 1080 may additionally or alternatively include a protrusion 1085 on the rod 1081, which may be configured to interact with the opening 1073 of the flange portion 1070, such that the protrusion 1085 may only move distally through the opening 1073. One side 1092 of the opening 1073 may be inclined to allow distal passage of the protrusion 1085 and to block proximal passage of the protrusion 1085 as the rod 1081 moves through the opening 1073. The protrusion 1085 and/or the side 1092 may have any shape or configuration suitable to achieve this purpose. In some embodiments, a shape or configuration of the 1085 protrusion and/or 1092 side may be selected to improve ease of manufacture (e.g., machining or molding of the 1085 protrusion shape and/or 1070 flange portion).

[0137] In other embodiments, the flange portion 1070 may include a movable lever 1071a, as seen in Figures 1Q-1T. The movable lever 1071a may include a first end 1071b extending out of the collar 1072 and a second end 1071c disposed within the collar 1072. The movable lever 1071a may be movable (e.g., hinged) around a pivot pin 1071d. The second end 1071c can be positioned within the opening 1073 so that the movable lever 1071a is configured to interact with the protrusion 1085 after receiving the piston rod 1080 in the flanged part 1070. With reference initially to Figure 1Q, the piston rod 1080 can be configured to prepare the device 1050, translating the rod 1081 distally through the flanged part 1070 until it meets the movable lever 1071a.

[0138] As seen in Figure 1R, the second end 1071c can abut against the protrusion 1085 when the movable lever 1071a is in an obstructing position. The second end 1071c can be configured to inhibit the translation of the piston rod 1080 relative to the flange part 1070 when the piston rod 1080 is in a primed position. It should be understood that a distance between the second end 1071c and the protrusion 1085 can define a priming distance to move the piston rod 1080 to the priming device 1050. The movable lever 1071a can be configured to move (e.g., pivot) relative to the collar 1072 and around the pivot pin 1071d to displace the second end 1071c from the obstructing position. The geometric axis of articulation, along which the pivot pin 1071d extends, may be substantially perpendicular to the longitudinal geometric axis along which the piston rod 1080 extends.

[0139] For example, as seen in Figure 1S, the movable lever 1071a can be actuated in response to the movement of the first end 1071b distally towards the flange 1076 and the pivot pin 1071d. In some embodiments, the first end 1071b can be actuated in response to receiving a distally directed force applied to it by, for example, a user of the device 1050. The second end 1071c can be moved in a proximal direction away from the flange 1076 and relative to the pivot pin 1071d in response to the first end 1071b moving distally, causing the second end 1071c to disengage the protrusion 1085.

[0140] Consequently, as shown in Figure 1T, the movable lever 1071a can allow the plunger rod 1080 to translate relative to the flange portion 1070 until the protrusion 1085 encounters a stop 1072a positioned at a distal end of the opening 1073. The stop 1072a can cause the plunger rod 1080 to settle into a dose-ending position when the protrusion 1085 is engaged therein. It should be understood that a distance between the second end 1071c and the stop 1072a can define a dose delivery distance for moving the plunger rod 1080 to dispense a controlled volume of substance from the device 1050.

[0141] As shown in Figures 1U and 1V, in some embodiments, the actuating portion 1082 of the piston rod 1080 may additionally or alternatively include one or more extensions 1087 configured to interface with the side openings 1094, 1095 in the collar 1072 of the flange portion 1070. The extensions 1087 may extend distally from the actuating portion 1082 and may have an angled or rounded distal portion dimensioned and configured to be pushed inward toward a central geometric axis of the piston rod 1080 when the actuating portion 1082 is pushed distally into the collar 1072. The angled or rounded distal portion of each extension 1087 may include a hook or clip-shaped part 1087a. The extensions 1087 can additionally be made of a flexible material, allowing them to be pushed into the collar 1072 and return outwards when no longer restricted by one side of the collar 1072. The side openings 1094, 1095 in the collar 1072 can be sized and configured to receive the hook or clip-shaped part 1087a of an extension 1087, so that once an extension 1087 reaches a side opening 1094 or 1095, a hook or clip-shaped part 1087a can spring out into the side opening 1094 or 1095 and subsequently prevent proximal movement of the plunger rod 1080. A number of extensions 1087 can coincide with a number of each of the side openings 1094 and 1095, so that each extension 1087 can be received in an opening. corresponding side 1094 or 1095 simultaneously as the piston rod 1080 moves distally relative to the flange part 1070.

[0142] Specifically, the first side openings 1094 can be configured to receive hook or clip-shaped parts 1087a of the extensions 1087 after the device 1050 is assembled, to prevent proximal movement of the plunger rod 1080 once the plunger rod 1080 is inserted into a ready-to-use position. As the hook or clip-shaped part 1087a of each extension 1087 is received into the first side openings 1094, it can make a "click" sound when it interfaces with the collar 1072, thus providing auditory and/or tactile feedback indicating that the device is in a ready-to-use position. In some embodiments, the first lateral openings 1094 may extend around a partial circumference of the collar 1072, so that the hook or clip-shaped parts 1087a of the extensions 1087 may be received in the lateral openings 1094 within a range of rotation positions of the piston rod 1080 relative to the flange part 1070. The secondary lateral openings 1095 may be configured to receive hook or clip-shaped parts 1087a of the extensions 1087 once the device 1050 is in a "delivery" configuration (e.g., after priming and further rotation of the actuating portion 1082 to align the protrusions 1086 with the slots 1074). In the embodiment depicted in Figures 1U and 1V, the extensions 1087 are longitudinally aligned with the protrusions 1086 and, as depicted in Figures 3C-3F, the lateral openings 1095 are similarly longitudinally aligned with the slots 1074, to allow distal movement of the actuating portion 1082 further into the collar 1072 when the device is in the "delivery" configuration. It should be understood that the device can be transitioned to the "delivery" configuration in response to the application of a distally directed force on the actuating portion 1082, to overcome an engagement of the side openings 1094 with extensions 1087 and a rotational force to overcome a frictional force between a collar interior 1072 and extensions 1087. However, in other embodiments, it is contemplated that the extensions 1087 and the side openings 1094, 1095 may be in any suitable complementary configuration to assist in controlling the proximal movement of the piston rod 1080.

[0143] In other embodiments, as shown in Figure 1W, the side openings 1094 can be positioned along the collar 1072 in longitudinal alignment with the side openings 1095. The device 1050 can be primed by receiving the hook or clip-shaped parts 1087a of the extensions 1087, initially positioned proximally to the side openings 1094, inside the side openings 1094. In some cases, feedback (e.g., tactile, auditory, etc.) can be generated in response to the extensions 1087 being received inside the side openings 1094. It should be understood that a proximal end of the collar 1072 can resist the distal advancement of the plunger rod 1080 relative to the flange part 1070 in response to the hook or clip-shaped parts 1087a being engaged in the collar 1072 at the side openings 1094. The application A force directed distally on the piston rod 1080 can cause the extensions 1087 to be released from the side openings 1094 and translated distally through the collar 1072 until received within the side openings 1095.

[0144] It should be understood that the distally directed force required to deflect the extensions 1087 inward and to release the hook or clip-shaped parts 1087a from the side openings 1094 may correspond to a minimum of priming and hydrodynamic force. Consequently, the piston rod 1080 may be maintained in a constant radial orientation during a priming step and delivery step of the device 1050. In other embodiments, additional and/or fewer side openings may be included along a circumferential wall of the collar 1072 in longitudinal alignment and/or deviation (e.g., not longitudinally aligned) with side openings 1094, 1095.

[0145] As seen in Figure 1X, the flange portion 1070 may alternatively include one or more internal projections 1095' instead of the side openings 1095' shown and described above. In this case, the plunger rod 1080 can be pre-assembled in the flanged part 1070 with extensions 1087 (Figure 1V) squeezed into the collar 1072 and positioned relatively proximal to the side openings 1094. The device 1050 can be primed by pushing the plunger rod 1080 distally through the flanged part 1070 until the extensions 1087 are received within the side openings 1094. In some cases, feedback (e.g., tactile, auditory, etc.) can be generated in response to the extensions 1087 being received within the side openings 1095. In other embodiments, the side openings 1094 can be enlarged and/or the extensions 1087 can have a distally tapering profile to facilitate further distal advancement of the plunger rod 1080 from a primed position to a finishing position. dose.

[0146] Further translation of the plunger rod 1080 relative to the flange portion 1070 can cause the extensions 1087 to bend radially inward toward each other, thus allowing the plunger rod 1080 to be translated distally to deliver a dose from the device 1050. The plunger rod 1080 can continue to translate distally relative to the collar 1072 until the hook or clip-shaped portions 1087a (Figure 1V) meet internal projections 1095'. The internal projections 1095' can be configured to contact the extensions 1087 and fix the plunger rod 1080 in the dose termination position and/or prevent further distal movement of the plunger rod 1080 relative to the flange portion 1070. Consequently, further movement (e.g., proximal and/or distal) of the plunger rod 1080 relative to the flange portion 1070 can be inhibited by internal projections 1095' engaging with hooks or clip-shaped parts 1087a within the collar 1072. The internal projections 1095' may include supplementary hooks or clip-shaped parts that are sized and/or shaped to interact with hooks or clip-shaped parts 1087a or extensions 1087. It should be understood that a distance between the side openings 1094 and the internal projections 1095' can define a delivery distance. Dosing mechanism for dispensing a controlled volume of substance from the 1050 device.

[0147] In other embodiments, as shown in Figures 2A-2C, the flange portion 1070 may include a fixed sleeve 1072P extending proximally from the collar 1072. The fixed sleeve 1072P may have a circular cross-section defining an internal channel with an opening at each terminal end of the fixed sleeve 1072P. The internal channel of the fixed sleeve 1072P may extend through a longitudinal length of the fixed sleeve 1072P and may be longitudinally aligned with the opening 1073 (Figure 1O) such that a respective longitudinal geometric axis of the internal channel and the opening 1073 are coaxial with each other. The fixed sleeve 1072P can be dimensioned, shaped, and configured to receive the rod 1081. In some embodiments, the fixed sleeve 1072P can be integral with the collar 1072, while in other embodiments the fixed sleeve 1072P can be a separate component mounted on the flange part 1070.

[0148] The fixed sleeve 1072P may include a plurality of openings that are sized and shaped to receive the protrusion 1085. For example, the fixed sleeve 1072P may include a pair of proximal openings 1072Q and a pair of distal openings 1072R spaced longitudinally from each other by a deviation distance. Furthermore, the pair of proximal openings 1072Q are located in the same longitudinal position as each other and the pair of distal openings 1072R are located in the same longitudinal position as each other. As described in more detail below, the longitudinal deviation between the proximal openings 1072Q and the distal openings 1072R can define a dosage delivery distance to move the plunger rod 1080 to dispense a controlled volume of substance from the device 1050. Alternatively, the longitudinal deviation between the openings 1072Q, 1072R can define a priming distance of the device 1050 so that the protrusion 1085 can be initially received within the proximal openings 1072Q during assembling the device 1050 to inhibit proximal retraction of the plunger rod 1080. In this case, a dosage delivery distance can correspond to a longitudinal deviation between a distal end of the actuating portion 1082 and a lower surface of the collar 1072 when the protrusion 1085 is received within the distal opening 1072R. Although not shown, it should be understood that an additional set of openings may be included in the fixed sleeve 1072P (e.g., proximal openings 1072Q, distal openings 1072Q and/or distal openings 1072R) to further define a priming distance and/or dosage delivery distance.

[0149] A proximal end of the fixed sleeve 1072P may include an angled interface 1071P defining a proximal opening of the fixed sleeve 1072P. The angled interface 1071P may be radially tapered inward toward the inner channel of the fixed sleeve 1072P and configured to guide the rod 1081 and the protrusion 1085 into the inner channel. In the present example, the protrusion 1085 may extend radially outward from the rod 1081 in opposite lateral directions and may be compressible and/or formed of a flexible/deformable material, such that the protrusion 1085 is configured to retract or deform radially inward and/or toward the rod 1081 in response to a force being applied thereto. In other embodiments, the protrusion 1085 can be configured to at least partially deform the fixed sleeve 1072P to facilitate movement of the protrusion 1085 towards and/or between the openings 1072Q, 1072R. In this case, the fixed sleeve 1072P can be formed of a flexible material operable to flex radially outwards when a distally directed force is applied to the rod 1081, causing the protrusion 1085 to apply a radial force to the fixed sleeve 1072P.

[0150] Referring again to Figure 2A, the fixed sleeve 1072P can be configured to receive the plunger rod 1080 through the internal channel and allow the rod 1081 to pass through the collar 1072 to the priming device 1050. The protrusion 1085 can be received within the fixed sleeve 1072P in response to the meeting of the angled surface 1071P and radial compression inwards relative to the rod 1081 until the plunger rod 1080 is moved distally enough so that the protrusion 1085 is received by the proximal openings 1072Q. As shown in Figure 2B, the protrusion 1085 can be configured to expand radially outward (decompress) when aligned longitudinally with the proximal openings 1072Q to lock the rod 1081 relative to the flange portion 1070. In this case, the device 1050 can be in a primed position so that further translation of the rod 1081 distally relative to the fixed sleeve 1072P and the flange portion 1070 can deliver a dose from the device 1050. Alternatively, the device 1050 can be pre-assembled with the protrusion 1085 received in the proximal openings 1072Q so that translation of the rod 1081 distally relative to the fixed sleeve 1072P can prime the device 1050 until the protrusion 1085 is received within the distal openings 1072R.

[0151] As seen in Figure 2C, while the protrusion 1085 is positioned within the proximal openings 1072Q, applying a distally directed force to the rod 1081 can cause the fixed sleeve 1072P to compress (or deform) the protrusion 1085 radially inward, thus allowing the rod 1081 to translate distally relative to the fixed sleeve 1072P. Alternatively, the protrusion 1085 can be manually compressed (or deformed) by applying a radially inward directed force through the proximal openings 1072Q. The protrusion 1085 can move distally through an internal channel of the fixed sleeve 1072P and can be received by the distal openings 1072R. As the rod 1081 translates distally in relation to the collar 1072, the device 1050 can transition from the primed position to a dose termination position when the protrusions 1085 are received within the distal openings 1072R, thus distributing the dose.

[0152] It should be understood that a volume of the dose delivered by the device 1050 can be controlled based on the longitudinal deviation distance between the proximal openings 1072Q and the distal openings 1072R. In some embodiments, the fixed sleeve 1072P may include additional openings to receive the protrusion 1085 after priming and dose delivery to inhibit proximal rod retraction 1081 (e.g., pulling back the plunger rod 1080) relative to the flange portion 1070. For example, the protrusion 1085 may be received within the proximal openings 1072Q during device assembly 1050 at a manufacturing stage so that the distal openings 1072R may define a priming position and a third set of openings (not shown) distal to the distal opening 1072R may define a dose delivery position. Alternatively, an inner lower surface of the flange portion 1070 distal to the distal opening 1072R may define the dose delivery position of the plunger rod 1080.

[0153] In some embodiments, as seen in Figures 2D-2G, the flange portion 1070 may include a movable sleeve 1072S extending distally and proximally from the collar 1072. The movable sleeve 1072S may have a circular cross-section defining an internal channel with an opening at each terminal end of the movable sleeve 1072S. The internal channel of the movable sleeve 1072S may extend through a longitudinal length of the movable sleeve 1072S. The movable sleeve 1072S may be dimensioned, shaped, and configured to be received through the opening 1073, and the internal channel of the movable sleeve 1072S may be dimensioned to receive the rod 1081. The movable sleeve 1072S may be fixed relative to the collar 1072 when in a pre-assembled configuration and may be movable relative to the collar 1072 after engagement with the plunger rod 1080.

[0154] The movable sleeve 1072S may include a plurality of openings that are sized and shaped to receive the protrusion 1085. For example, the movable sleeve 1072S may include a proximal opening 1072U at a proximal end of the movable sleeve 1072S and a distal opening 1072T at a distal end of the movable sleeve 1072S. A proximal end of the movable sleeve 1072S may further include an angled interface 1071S that defines a proximal opening of the movable sleeve 1072S. The angled interface 1071S may be radially tapered inward toward the inner channel of the movable sleeve 1072S and configured to guide the rod 1081 and the protrusion 1085 into the inner channel of the movable sleeve 1072S. In some embodiments, the protrusion 1085 may extend radially outward from the rod 1081 in opposite directions and may be compressible such that the protrusion 1085 is configured to be compressed inward and/or toward the rod 1081 in response to a force being applied to it.

[0155] Referring again to Figure 2D, the proximal end of the movable sleeve 1072S can be positioned adjacent to a proximal end of the collar 1072 and a distal end of the movable sleeve 1072S can be positioned adjacent to a distal end of the collar 1072 when in the pre-assembled position. The plunger rod 1080 can be received through the inner channel of the movable sleeve 1072S with the rod 1081 extending through the collar 1072. The protrusion 1085 can be received within the distal opening 1072T so that the plunger rod 1080 can be attached to the movable sleeve 1072S. The protrusion 1085 can be configured to exit the distal opening 1072T and expand laterally outward in response to the plunger rod 1080 translating relative to the movable sleeve 1072S.

[0156] For example, as shown in Figure 2E, applying a distally directed force to the actuating portion 1082 can cause the protrusion 1085 to compress radially inward, thus allowing the rod 1081 to transform distally relative to the movable sleeve 1072S. In this case, the protrusion 1085 can exit the distal opening 1072T and expand as it translates distally from a distal end of the movable sleeve 1072S. The device 1050 can transition from a pre-assembled state to a primed state, in response to the rod 1081 translating distally relative to the collar 1072, until the actuating portion 1082 contacts a proximal end of the movable sleeve 1072S. In this case, device 1050 may be in a primed state and further translation of rod 1081 relative to collar 1072 may be inhibited by the presence of movable sleeve 1072S.

[0157] Now, with reference to Figure 2F, the piston rod 1080 can engage with the movable sleeve 1072S in response to the proximal translation of the rod 1081 relative to the collar 1072 until the protrusion 1085 engages with the proximal opening 1072U. It should be understood that the protrusion 1085 may be in a compressed state when translating through an internal channel of the movable sleeve 1072S and may expand to the proximal opening 1072U by longitudinal alignment with it. With the protrusion 1085 engaged in the proximal opening 1072U, a distal translation of the plunger rod 1080 relative to the flange portion 1070 can provide a simultaneous movement of the movable sleeve 1072S relative to the collar 1072. It should be understood that a collective length of the movable sleeve 1072S and plunger rod 1080 can be greater than a longitudinal length of the plunger rod 1080 alone.

[0158] As seen in Figure 2G, the plunger rod 1080 can be configured to move the movable sleeve 1072S through a channel of the flange portion 1070 for a predetermined distance until the actuating portion 1082 encounters a proximal end of the collar 1072. The plunger rod 1080 can be configured to deliver a dose from the device 1050 in response to the translation of the movable sleeve 1072S distally relative to the collar 1072. It should be understood that the dosage delivered by the device 1050 can be controlled based on the predetermined distance between the actuating portion 1082 and the collar 1072 when the protrusion 1085 is received within the proximal opening 1072U. In some embodiments, the flange portion 1070 can be configured to inhibit proximal movement of the movable sleeve 1072S relative to the collar 1072 when the protrusion 1085 is received within the proximal opening 1072U. Although not shown, the flange portion 1070 may include one or more operable locking components to restrict proximal retraction of the movable sleeve 1072S from the opening 1073.

[0159] In other embodiments, as seen in Figures 2H-2M, the piston rod 1080 may include at least one protrusion 1085W positioned on the actuating portion 1082. In the example, the protrusion 1085W may be positioned on or adjacent to a distal end of the actuating portion 1082 so that the protrusion 1085W may be received within the flange portion 1070 in response to the translation of the piston rod 1080 in the collar 1072.

[0160] As seen in Figure 2K, the flange portion 1070 may include one or more channels formed along an inner surface of the collar 1072. In particular, the collar 1072 may include a first (proximal) helical channel 1071W formed along an interior of the collar 1072 and having a first curvature and a second (distal) helical channel 1072W formed along the interior of the collar 1072 and having a different and/or opposite curvature to that of the first helical channel 1071W. For example, when viewed from the proximal end of the actuating portion 1082, the first helical channel 1071W may be concave, while the second helical channel 1072W may be convex when viewed from the same viewpoint. Alternatively, the first helical canal 1071W may be convex when viewed from the proximal end of the actuating portion 1082, while the second helical canal 1072W is concave from the same viewpoint. Furthermore, the second helical canal 1072W may be longitudinally spaced from the first helical canal 1071W. The first helical canal 1071W may be connected to the second helical canal 1072W by a third intermediate canal 1073W extending between them.

[0161] The third channel 1073W may extend along or substantially parallel to a longitudinal geometric axis of the collar 1072. It should be understood that the size, shape, and/or orientations of one or more channels in the collar 1072 are merely illustrative, so other suitable configurations may be included without departing from the scope of this disclosure. As described in detail below, the plurality of channels 1072 is configured to receive the protrusion 1085W. In some embodiments, the first helical channel 1071W and the second helical channel 1072W may be threaded and configured to engage with a corresponding component of the piston rod 1080 (e.g., protrusion 1085W). Opposite rotational motion may be required for the protrusion 1085W to pass through the first helical channel 1071W and the second helical channel 1072W. For example, an initial rotational movement of the actuating portion (e.g., clockwise) may cause the 1085W protrusion to pass through the first helical channel 1071W, while an opposite rotational movement (e.g., counterclockwise) may cause the 1085W protrusion to pass through the second helical channel 1072W.

[0162] Referring to Figure 2H, with the piston rod 1080 in a ready position, the protrusion 1085W can be received within the collar 1072 in response to a distal translation of the actuating portion 1082 towards the flange portion 1070. As seen in Figure 2I, the protrusion 1085W can be received within the first helical channel 1071W and moved through it in response to a rotation of the piston rod 1080 (e.g., in a first direction) relative to the flange portion 1070. It should be understood that the piston rod 1080 can be configured to translate axially in a distal direction relative to the flange portion 1070 as the piston rod 1080 rotates within the collar 1072, due to the curvature of the first helical channel. 1071W. For example, the piston rod 1080 can translate a first distance defined by a configuration of the first helical channel 1071W until it reaches a terminal end of the first helical channel 1071W. The first distance can correspond to a priming step of the device 1050, so that the device 1050 can be at least partially primed after the protrusion 1085W moves through the first helical channel 1071W.

[0163] Now, with reference to Figure 2J, the protrusion 1085W can be positioned at a terminal end of the first helical channel 1071W and a proximal end (e.g., top) of the third channel 1073W. In some embodiments, the plunger rod 1080 can experience tactile feedback formed by the terminal end of the first helical channel 1071W. The plunger rod 1080 can be translated distally through the third channel 1073W to complete a priming step of the device 1050, as shown in Figure 2K. It should be understood that the first helical channel 1071W and the third channel 1073W can collectively define a priming distance of the device 1050 such that the piston rod 1080 is in a primed position when the protrusion 1085W translates through the third channel 1073W.

[0164] With the protrusion 1085W received within the second helical channel 1072W, the piston rod 1080 can be rotated in the second direction (opposite to the first direction) to translate the piston rod 1080 distally by a second distance that is defined by a configuration of the second helical channel 1072W. The second distance can be smaller, larger and/or substantially equal to the longitudinal dimension of the second helical channel 1072W, depending on the particular application and need. The plunger rod 1080 can be rotated in the second direction and translated through the second distance until it reaches a terminal end of the second helical channel 1072W to deliver a dose from the device 1050. It should be understood that the second distance may correspond to a dose delivery step of the device 1050, such that the device 1050 can deliver the dose by moving the protrusion 1085W through the second helical channel 1072W and reaching a dose termination position.

[0165] In other embodiments, as seen in Figures 2L-2O, the plunger rod 1080 may include a protrusion, a button and/or a thread 1085X positioned on the actuating portion 1082. In the example, the wire 1085X may be positioned around a circumference of the actuating portion 1082 and along a distal end so that the wire 1085X may be received within the flange portion 1070 in response to the translation of the plunger rod 1080 in the collar 1072.

[0166] The flange portion 1070 may additionally include a threaded portion 1072X disposed within the opening 1073 and forming a helical path that is configured to receive the thread 1085X. In the example, the threaded portion 1072X may be positioned along a proximal portion of the opening 1073 so that a distal portion of the opening 1073 may include a non-threaded portion 1071X. As described in more detail in this document, the threaded portion 1072X may define a longitudinal distance corresponding to a priming step of the device 1050 and the non-threaded portion 1071X may define a distance corresponding to a dosing delivery step of the device 1050.

[0167] For example, as seen in Figure 2L, the actuating portion 1082 can be translated distally toward the flange portion 1070 until the thread 1085X encounters a distal end of the collar 1072. Rotation of the piston rod 1080 in a first direction (e.g., clockwise or counterclockwise) can cause the thread 1085X to engage the threaded portion 1072X. As shown in Figure 2M, rotation of the piston rod 1080 can provide axial/longitudinal translation of the actuating portion 1082 to the collar 1072 as the thread 1085X moves through the helical path of the threaded portion 1072X. It should be understood that the rotation and translation of the 1085X thread through the 1072X threaded portion can transition the 1050 device from a ready position (Figure 2L) to a primed position (Figure 2N). With the 1085X thread disengaged from the 1072X threaded portion and positioned along the 1071X unthreaded portion, the 1050 device can be in the primed position. In some cases, feedback (e.g., tactile, auditory, etc.) can be generated in response to the 1085W thread exiting the 1072X threaded portion and/or entering the 1071X unthreaded portion.

[0168] In this case, as shown in Figure 2O, the actuating portion 1082 can be translated distally relative to the flange portion 1070 to deliver a dose from the device 1050 by applying a force directed distally against the actuating portion 1082. The thread 1085X can move through the distal portion of the opening 1073 when the thread 1085X is positioned within the unthreaded portion 1071X. A longitudinal length of unthreaded portion 1071X defined between a distal end of the threaded portion 1072X and a distal end of the opening 1073 can control a dose delivery of the device 1050. The device 1050 can complete the delivery of a dose when the actuating portion 1082 engages with a proximally and distally facing surface of the collar 1072 and the plunger rod 1080 reaches the dose completion position.

[0169] Figures 2P-2T illustrate other embodiments of a flange part that can be configured and operated similarly to flange part 1070 shown and described above, except for the differences explicitly noted in this document. It should be understood that similar reference numbers are used to identify similar components and the flange parts described below can be readily incorporated with one or more components of device 1050 shown and described above.

[0170] For example, referring initially to Figure 2P, a flange portion 1070A may include one or more flanges 1076A that can be sized and configured to assist a user in holding the device 1050 and/or expelling a formulated pharmacological substance from the device 1050. The flanges 1076A may be further sized and/or shaped to allow a user to hold the device 1050 with a plurality of hand/grip positions, arrangements, and/or orientations. By way of illustrative example, the flanges 1076A may be sized and/or shaped so that the flange portion 1070A can be held similarly to a writing instrument (e.g., pencil, pen, etc.) without requiring the use of flanges 1076A, or sized according to the example shown in Figure 24A so that the flanges 1076A can rest on one or more of a user's fingers. The flange portion 1070A may include a pair of flanges 1076A that extend radially outward from the collar 1072 in radially opposite directions relative to each other. The flanges 1076A may extend transversely from the collar 1072 (for example, the flanges 1076A may include an angled surface that is radially inclined inward in a distal direction) and configured to inhibit a user's fingers from slipping off the flange portion 1070A during use of the device 1050.

[0171] Flanges 1076A can be coupled together to form a semicircular profile with a minimum radius relative to collar 1072. Consequently, flanges 1076A can form a thin profile to facilitate visualization of a target treatment site at a distal end of device 1050 (not shown) when using device 1050 from a proximal perspective of finger flange 1070A. It should be understood that the flange portion 1070A may include various other quantities and/or arrangements of flanges 1070A beyond those shown and described herein, without departing from the scope of this disclosure. In other embodiments, flanges 1076 may include various other suitable sizes and/or shapes.

[0172] The flange portion 1070A may additionally include a distal collar 1075A extending distally from the collar 1072 and configured to engage the body 1060 to hold the flange portion 1070A in a fixed position relative to the body 1060. The distal collar 1075A may be adhered, molded, or otherwise affixed to the body 1060 or may engage the body 1060 by means of a friction fitting. In the example, the distal collar 1075A includes a longitudinal length that is generally shorter than the longitudinal length of the collar 1072. In some embodiments, the distal collar 1075A may be sized sufficiently small to facilitate adequate exposure of the body 1060 for user gripping and/or manipulation during use of the device 1050. Furthermore, the distal collar 1075A may include a material composition that is similar to and/or different from the collar 1072. For example, the distal collar 1075A may be formed of a flexible material, such that the distal collar 1075A may be configured to flex radially outward upon receiving the body 1060 at the flange portion 1070A and flex radially inward once the body 1060 is fully received to facilitate a press-fit connection (without breaking the distal collar 1075A). It should be understood that, in other embodiments, the flange part 1070A may omit the distal collar 1075A entirely.

[0173] In other embodiments, as seen in Figure 2Q, a flange portion 1070B may include a distal collar 1075B that is substantially longer than the distal collars 1075, 1075A shown and described above. For example, the distal collar 1075B may be enlarged with a longitudinal length that is greater than a longitudinal length of the collar 1072. In the example, the distal collar 1075A may be sized large enough to span a substantial length of the body 1060. In this case, an outer surface of the distal collar 1075B may provide an interface for a user to grasp and/or manipulate during use of the device 1050. Furthermore, the distal collar 1075B may include an expanded diameter that exceeds a body diameter 1060 to provide an enhanced surface area for grasping the flange portion 1070B. In other words, the distal collar 1075B may have an enlarged size and/or shape to facilitate gripping and/or manipulation of the device 1050. In the present example, the distal collar 1075B may have a cylindrical shape with a convex outer surface when viewed from the outside of the flange portion of the device 1070B.

[0174] Alternatively, as seen in Figure 2R, a flange portion 1070C may include a distal collar 1075C that is substantially similar to the distal collar 1075B and includes a longitudinal length that is greater than a longitudinal length of the collar 1072. In the example, an outer surface of the distal collar 1075C may be configured to provide an interface for a user to grasp and/or manipulate during use of the device 1050. The distal collar 1075C may include a thin profile with a diameter that is greater than the diameter of the body 1060 so that the distal collar 1075C does not substantially increase a body profile 1060. In other words, the distal collar 1075C may have a narrow size relative to the distal collar 1075B. In some embodiments, the distal collar 1075C may include a terminal projection 1077C that extends radially outward at one distal end. The terminal projection 1077C may be sized, shaped, and configured to improve the grip and/or manipulation of the distal collar 1075C. In the present example, the distal collar 1075C may have an enlarged shape with a concave outer surface when viewed from an exterior of the flange portion of the device 1070C.

[0175] In other embodiments shown in Figures 2S-2T, a flange portion 1070D may include a collar 1072D that has a proximal shoulder 1074D. The proximal shoulder 1074D may define an irregular surface configured to interface with the piston rod 1080 when the actuating portion 1082 is received by the collar 1072D. For example, the proximal shoulder 1074D may include a pair of recessed surfaces 1075D positioned along opposite sides of each other along the proximal shoulder 1074D. In other words, the recessed surfaces 1075D may be separated from each other by surfaces and/or portions of the proximal shoulder 1074D that are not recessed. In the example, the recessed surfaces 1075D can be positioned adjacent to the slots 1074 and can define a path to move the plunger rod 1080 relative to the collar 1072D to prime and deliver a dose from the device 1050. In some embodiments, the recessed surfaces 1075D may include a spiral configuration (e.g., have a distally directed slope) so that the recessed surfaces 1075D can be tapered in a distal direction between a first protrusion 1073D and a second protrusion 1076D.

[0176] In some embodiments, the flange portion 1070D may include display mechanisms, such as, for example, one or more labels or markings arranged on the collar 1072D to provide instructions to a user of the device 1050. For example, one or more labels (e.g., numbering) may indicate directions in which to rotate or move the plunger rod 1080 relative to the flange portion 1070D to prepare and deliver a dose from the device 1050. By way of example, one or more labels may include markings indicating an initial position (e.g., "1"), a priming position (e.g., "2"), and a dose delivery position (e.g., "3") of protrusions 1086 relative to the proximal protrusion 1074D. The one or more labels may be adhered, printed, embossed, and/or molded onto the collar 1072D.

[0177] As described in more detail in this document, the flange portion 1070D can be configured to allow movement of the plunger rod 1080 in a single direction when preparing and delivering a dose from the device 1050. In exemplary use, the plunger rod 1080 (not shown) can initially be received through the flange portion 1070D and the actuating portion 1082 can be positioned against the collar 1072D with protrusions 1086 positioned along a first end of the recessed surfaces 1075D at marking "1" and opposite the slot 1074. The protrusions 1086 can only be rotated in a single direction along the re-entrant surface 1075D, to marking "2," because the first protrusion 1073D inhibits protrusions 1086 from moving in an opposite direction away from marking “2”.

[0178] When protrusions 1086 are received along recessed surfaces 1075D at marking “2,” a second protrusion 1076D can prevent further protrusions 1086 from moving beyond slots 1074 and passing through a marking “3.” It should be understood that a proximal protrusion configuration 1074D is exemplary, so that the flange portion 1070D may include various other sizes, shapes, and/or configurations of proximal protrusions 1074D and/or recessed surfaces 1075D than those shown and described herein to facilitate piston rod movement 1080 during use of device 1050.

[0179] In other embodiments, the components of device 1050 may include one or more color indicators instead of and/or in addition to the markings described above to provide instructions to a user of device 1050. For example, device 1050 may include colors, symbols (e.g., arrows) and the like, indicating a direction in which to rotate or move the plunger rod 1080 relative to the flange portion 1070D to prepare and deliver a dosage. In one embodiment, an outer surface of the plunger rod 1080 may be provided with different colors along various portions of the actuating portion 1082 to indicate a respective initial position (e.g., green), priming position (e.g., yellow) and dosage delivery position (e.g., red) of the plunger rod 1080 relative to the collar 1072D. One or more color indicators may be printed or molded onto the plunger rod 1080. In other embodiments, the various portions of the plunger rod 1080 may include different textures instead of and/or in addition to the color indicators described above to provide instructions to a user of the device 1050.

[0180] The components of device 1050 may be made of any suitable material, and each component may be made of the same or different materials as other components. It should be understood that in some embodiments, one or more components of device 1050 (e.g., flange portion 1070, proximal collar 1072, plunger rod 1080, actuating portion 1082, and more) may be formed of a flexible material with sufficient flexibility to prevent breakage during bending. In some embodiments, one or more components of device 1050 may be rigid and have sufficient strength to maintain shape and provide support. In other embodiments, one or more components of device 1050 (or at least a portion of a component) may have variable stiffness along a longitudinal length or lateral width, so that the component may have variable flexibility. In still other embodiments, one or more components of the device 1050 may have sufficient flexibility to prevent breakage during bending, while also having sufficient rigidity and strength to maintain shape and provide support. In some embodiments, such features may even provide user feedback (e.g., tactile, audible, visual, etc.) when bending and/or interacting with other components of the device 1050. For example, each body 1060, flange part 1070, and plunger rod 1080 may be made of a material that includes a polymer, such as a plastic. In some embodiments, one or more of the body 1060, flange part 1070, and plunger rod 1080 may include several different materials (e.g., glass, rubber, and/or plastic). In some embodiments, for example, the cylindrical portion of the body 1060 may be made of glass, Plexiglas, or any other suitable polymer (for example, cyclic olefin polymer or cyclic olefin copolymer) or other material, and the stop 1062 may be made of, for example, plastic, rubber, or other polymer or copolymer. By way of further example, the flange portion 1070 may include a polypropylene homopolymer, an ABS (acrylonitrile butadiene styrene) polymer, an ABS polycarbonate blend, and other suitable materials. In some embodiments, the plunger rod 1080 may include an ABS polycarbonate blend. Such materials may provide greater tolerances for the manufacture (e.g., injection molding) of the flange part 1070 and/or plunger rod 1080 or facilitate greater reproducibility of said components of the device 1050. As described in more detail above, in some embodiments, one or more components of the device 1050 may be formed from a flexible and/or deformable material composition providing greater tolerances for bending or deformation of said components (e.g., without breaking) when preparing or delivering a dose of the device 1050.

[0181] In some embodiments, a portion of the body 1060 configured to contain a formulated pharmacological substance may be made of a transparent or translucent material. In some embodiments, the flange portion 1070 and the plunger rod 1080 may be made of the same, similar, or different material, such as similar or different plastics (e.g., each having a similar or different hardness). In some embodiments, the parts of the device 1050 may include elastic materials. For example, the parts of the device 1050 may include rubber or plastic configured to allow a user to better grip the device 1050 or create a hermetic or otherwise sealing fit between two components of the device 1050 (e.g., between the body 1060 and the stop 1062). In some embodiments, part or all of the plunger rod 1080 (for example, actuating part 1082 and/or extensions 1087, or alternatively the entire plunger rod 1080) may be made of a material with some flexibility, for example, to allow bending of the extensions 1087. One or more of the materials listed above (for example, plastic, rubber, polymers or copolymers) may have such characteristics. In some embodiments, some or all of the devices 1050 may be suitable for sterilization, for example, heat or chemical sterilization.

[0182] Figures 2A and 2B depict an exemplary method of assembling the delivery device depicted in Figures 1A-1E. The flange part 1070 can be mounted onto the body 1060, as shown in Figure 2A. The assembly of the flange part 1070 to the body 1080 can involve sliding, fitting, adhering, or otherwise securing the two components together. As depicted in Figure 2A, the flanged part 1070 can be slid into the body 1060, for example, so that the protrusion 1071 of the flanged part 1070 engages with the body flange 1061. The plunger rod 1080 can be inserted through the assembled flanged part 1070 and the body 1060, so that a distal end of the plunger rod 1080 contacts the stop 1062. The assembled device 1050 can then be in a configuration suitable for packaging, sterilization and/or use.

[0183] Figures 3C-3F depict an exemplary method of assembling the device 1050 in which the actuating portion 1082 includes extensions 1087 and the collar 1072 includes side openings 1094. In such an embodiment, the plunger rod 1080 can be inserted through the flange portion 1070 until the hook or clip portions of the extensions 1087 are received within the side openings 1094, at which point the assembled device 1050 can be in a configuration suitable for packaging, sterilization and/or use. It should be understood that the side openings 1094 can be configured to inhibit a proximal retraction of the plunger rod 1080 relative to the flange portion 1070, once the hook or clip portions of the extensions 1087 are received therein. The side openings 1094 can function as a first latch when the device 1050 is placed in an initial assembly state to prevent disassembly of the device 1050.

[0184] As described in more detail in this document (see Figures 4G-4J), the side openings 1095 can be configured to inhibit proximal retraction of the plunger rod 1080, since the hook or clip portions of the extensions 1087 are received therein. The side openings 1095 can function as a second lock when the device 1050 is placed in a dosing delivery state to prevent fluid extraction from the patient after drug/medication delivery is complete. It should be understood that the side openings 1094, 1095 can generate feedback indicating a relative position of the plunger rod 1080 to the flange portion 1070, such as, for example, audible feedback, tactile feedback, and the like. In some embodiments, the device 1050 may include additional and/or fewer side openings 1094, 1095 than those shown and described herein to increase and/or decrease the number of locks on the device 1050.

[0185] In some embodiments, the mounting device 1050 may include the pre-filling body 1060 before combining it with the flange part 1070 and the stop 1080; For example, a predetermined quantity of pharmacological substance may be disposed in the body 1060 between the stop 1062 and the needle end 1064. In some embodiments, an alternative order of assembly of the components of the device 1050 may be employed, depending on the variations contemplated in the structures of the components of the device 1050. For example, in an embodiment (not shown) where the flanged part 1070 is configured to be mounted on the body 1060 using a pressure-fit interface, the plunger rod 1080 may first be inserted through the flanged part 1070 and the combined flanged part 1070 and plunger rod 1080 may be mounted on the body 1060, for example, so that the flanged part 1070 fits over a proximal body flange 1061 of the body 1060 and the plunger rod 1080 is inserted into the body 1060.

[0186] Figures 4A-4F depict an exemplary method of using device 1050, in accordance with aspects of the present disclosure. In a pre-use configuration depicted in Figure 4A, the device 1050 may contain a volume of a pharmacological substance between the stop 1062 and the expulsion end 1064. A priming distance p may exist between the protrusions 1086 and a proximal end of the proximal collar 1072, and the protrusions 1086 may be misaligned with the slots 1074. In a priming step depicted in Figure 4B, the plunger rod 1080 may be moved longitudinally further into the body 1060. For example, a user may press the actuating portion 1082 partially into the proximal collar 1072 of the flange portion 1070. In some embodiments, the device 1050 may be held in an inverted position during this step to ensure that air trapped in the body 1060 can be expelled through the expulsion end. 1064, as the stop 1062 is pushed distally by the plunger rod 1080. In the pre-use configuration of Figure 4A and during the priming step shown in Figure 4B, the plunger rod 1080 can be prevented from rotating around the longitudinal geometric axis of the syringe, due to the geometries of the opening 1073 in the flange part 1070 and neck 1084 of the plunger rod 1080 (as shown in the top cross-sectional view in Figure 4B). As shown in Figure 4C, the priming step can be interrupted when the protrusions 1086 of the piston rod 1080 abut a proximal end of the proximal collar 1072. When the priming step is complete, the neck 1084 of the piston rod 1080 can be positioned longitudinally relative to the opening 1073 of the flange portion 1070, so that it can now be rotated relative to the flange portion 1070. For example, when the priming step is complete, a narrower portion of the neck 1084 can be disposed within the opening 1073 than when the device was in a pre-use configuration.

[0187] As depicted in Figure 4D, the device 1050 may be in a primed configuration. In a delivery priming step depicted in Figure 4E, the plunger rod 1080 may be rotated about a longitudinal geometric axis to align the protrusions 1086 with the slots 1074. To do this, a user may grasp and twist the actuating portion 1082. In some embodiments, as described elsewhere, it may be possible to twist the actuating portion 1082 in either direction to align the protrusions 1086 and the slots 1074. In other embodiments, the actuating portion 1082 may be rotatable in only one direction. In some embodiments, once the protrusions 1086 are aligned with the slots 1074, further rotation of the plunger rod 1080 relative to the flange portion 1070 can be prevented, for example, by contact between the neck geometries 1084 and the opening 1073. Thus, alignment of protrusions 1086 and slots 1075 can lock the device 1050 in a ready-to-dispense configuration. In some embodiments, rotation of the actuating portion 1082 can align the protrusions 1086 with the slots 1074 and can allow the plunger rod 1080 to remain longitudinally stationary relative to the flange portion 1070 (e.g., no proximal or distal movement of the plunger rod 1080 is caused by rotation of the actuating portion 1082). As depicted in Figure 4F, in one delivery step, the plunger rod 1080 can be moved longitudinally further into the body 1060. For example, a user can press the actuating portion 1082 distally into the proximal collar 1072 of the flange part 1070, so that the protrusions 1086 slide into the slots 1074. Once the protrusion 1086 abuts the distal ends of the slots 1074, further distal movement of the plunger rod 1080 is stopped. The delivery step can ensure that a predetermined volume of a pharmacological substance within the body 1060 is dispensed from the device 1050. In some embodiments, when the protrusions 1086 abut the distal ends of the slots 1074, the stop 1062 does not "bottom out" or abut the inside of the ejection end 1064 in the body 1060. Advantageously, by ensuring that a predetermined volume of a pharmacological substance within the body 1060 is dispensed from the device 1050 before the stop 1062 can bottom out, any variations in the manufacture of the ejection end 1064 (e.g., altering the exact size or shape of the ejection end 1064) are less likely to affect the predetermined volume of the pharmacological substance that is delivered from the device 1050. In fact, in some embodiments, the predetermined volume of the pharmacological substance that is dispensed from the device 1050 It may not be affected by typical manufacturing variations in any component of the device 1050, particularly in any component except for the flange part 1070. Advantageously, this may allow for different or greater tolerances in manufacturing variation in various components of the device 1050 (for example, variations in the formation of a glass body 1060 or other glass components), without affecting the predetermined volume of pharmaceutical substance to be dispensed from the device 1050.

[0188] In some embodiments, after one or more steps in the use of the device 1050, a user may be prevented from redoing a step and/or reversing one or more steps. For example, geometries of, for example, plunger rod neck 1084 and opening 1073 may prevent a user from pulling the plunger rod 1080 proximally (e.g., out of) the body 1060, from rotating the plunger rod 1080 preventively (e.g., before the priming step shown in FIG. 4C), and/or from the plunger rod over-rotating 1080 during a delivery priming step (e.g., shown in Figure 4E). In particular, Figures 4G-4J depict the steps in using an embodiment of the device 1050 with extensions 1087 in the actuating portion 1082 and corresponding side openings 1094, 1095 in the collar 1072 of the flange portion 1070. Figures 4G and 4H depict the device 1050 as the actuating portion 1082 is being pushed distally into the collar 1072. Due to their angled distal portions, the extensions 1087 are pushed inward into the collar 1072. Once the plunger rod 1080 has been rotated to a “delivery” position and the actuating portion 1082 is further pushed distally into the collar 1072 to deliver a predetermined volume of drug substance from the device 1050, extensions 1087 can be received in side openings. 1095 (shown in Figures 4I and 4J), subsequently restricting the proximal movement of the plunger rod 1080. Advantageously, restricting the proximal movement of the plunger rod 1080 can prevent the inadvertent withdrawal of material into the device 1050 from, for example, a site where a pharmacological substance is dispensed. In some embodiments, the device 1050 may include side openings 1094 or side openings 1095. In other embodiments, as shown in Figures 4G-4J, the device 1050 may include both side openings 1094 and side openings 1095.

[0189] Figures 4K and 4O depict in more detail exemplary aspects of a neck geometry 1084, which can help control the movement of the piston rod 1080. For example, a more proximal portion a of the neck 1084 and rod 1081 (indicated by section d in Figure 4K) may have a first cross-sectional shape, as shown in Figure 4L. This shape may allow corresponding portions of the piston rod 1080 to move proximally/distally through an opening (e.g., opening 1073) of a locking component (e.g., flange part 1070), but may prevent rotation of the piston rod 1080 around a longitudinal geometric axis. A narrow portion b of the neck 1084 may have a smaller cross-sectional shape, as shown in Figure 4M. This shape, when disposed in an opening (e.g., opening 1073) of a locking component (e.g., flange part 1070), can allow unidirectional or bidirectional rotation of the piston rod 1080 around a longitudinal geometric axis. It should be understood that the respective portion of the neck 1084 allowing the transition rotation of the piston rod 1080 (e.g., in the narrow portion b) may have a geometry with the smallest cross-sectional shape to allow greater space for such movement, relative to the cross-sectional shapes of other portions of the piston rod 1080. A third portion c of the neck 1084 may have a larger cross-sectional shape, as shown in Figure 4N, which may directly correspond to the size and shape of an opening (e.g., opening 1073) of a locking component (e.g., flange part 1070). Therefore, proximal or distal movement of this portion of the neck 1084 through the opening 1073 is only possible when the piston rod 1080 is in a specific rotational orientation relative to the flange portion 1070. Furthermore, the piston rod 1080 will not rotate while portion c of the neck 1084 is disposed within the opening 1073. This can ensure that, for example, the piston rod 1080 is in a desirable position relative to the flange portion 1070 (e.g., priming is complete and portion c is no longer disposed within the opening 1073) before the piston rod 1080 can be rotated. Together, the various cross-sectional shapes of the neck 1084 and the size and shape of the opening 1073 can combine to create a specific sequence of plunger rod 1080 movements required to prepare and deliver a pharmaceutical substance from the device 1050. In the example, a distal portion of the opening 1073 may have the largest cross-sectional profile relative to an intermediate and/or proximal portion of the opening 1073 to accommodate the varying geometries of the plunger rod 1080 through it (e.g., neck 1084, rod 1081, etc.).

[0190] In another embodiment depicted in Figure 4O, a more proximal portion e of the neck 1084 and a larger portion h of the rod 1081 may both have a first cross-sectional shape, as shown in Figure 4P. This shape may allow corresponding portions of the piston rod 1080 to move proximally/distally through an opening (e.g., opening 1073) of a locking component (e.g., flange part 1070), but may prevent rotation of the piston rod 1080 about a longitudinal geometric axis. A narrow portion f of the neck 1084 may have a smaller winged (or arrow-shaped) cross-sectional shape, as shown in Figure 4Q (in a pre-rotation configuration relative to the flange part 1070) and Figure 4R (in a post-rotation configuration relative to the flange part 1070). This "winged" shape, when disposed in an opening (e.g., opening 1073) of a locking component (e.g., flange part 1070), can allow unidirectional or bidirectional rotation of the piston rod 1080 around a longitudinal geometric axis and can restrict or resist "backward" rotation of the piston rod 1080 in the opposite direction after rotation has been completed (as described later in relation to Figures 4T-4X). Portions g and l of the piston rod 1080 may have a larger cross-sectional shape, as shown in Figure 4S, which may directly correspond to the size and shape of an opening (e.g., opening 1073) of a locking component (e.g., flange part 1070). Therefore, proximal or distal movement of these portions of the piston rod 1080 through the opening 1073 is only possible when the piston rod 1080 is in a specific rotational orientation relative to the flange portion 1070. Furthermore, the piston rod 1080 will not rotate while the g or l portions of the piston rod 1080 are positioned within the opening 1073. This can ensure that, for example, the piston rod 1080 is in a desirable position relative to the flange portion 1070 at certain stages during the assembly and use of the device 1050, allowing for precise assembly and use of the device 1050. Additionally, the “larger” cross-sectional area of portions G and L can aid in preventing piston rod “return,” as it will not have the capacity to move proximally through the opening 1073 unless in a specific position. a determined rotation relative to the flange portion 1070. For example, after rotation of the plunger rod 1080 from a "primed" position to a "delivery" position, the g portion of the plunger rod 1080 may not be able to move through the opening 1073, thus preventing the "return" of the plunger rod at that stage of use of the device 1050. Together, the various cross-sectional shapes of the plunger rod 1080 and the size and shape of the opening 1073 can combine to create a specific sequence of movements of the plunger rod 1080 necessary to assemble, prepare, and deliver a pharmaceutical substance from the device 1050.

[0191] Figures 4T-4X depict in more detail the specific interactions between a wing-shaped portion of the neck 1084 and the opening 1073 in the flange portion 1070. The flange portion 1070 may include retainers 1078 adjacent to or within the opening 1073, which may interact with the wings 1089 in the neck 1084. Figure 4T represents a cross-sectional view of the opening 1084 into the neck 1073 with a pre-rotation configuration (e.g., after the device 1050 has been primed, but before the plunger rod 1080 has been rotated to a “delivery” configuration relative to the flange portion 1070). Figure 4U represents that, as the piston rod 1080 is rotated around a longitudinal geometric axis, one of the wings 1089 may come into contact with one of the latches 1078 (depending on the direction of rotation). As the rotation continues, one of the detents 1078 may cause one of the wings 1089 to be compressed towards the remainder of the neck 1084. When the rotation is complete, the wing 1089 has passed the latches 1078 and expanded. This expansion of a retaining wing 1089 past 1078 may cause an auditory “click” feedback and/or a tactile return to indicate that rotation is complete, and may subsequently prevent “backward” rotation of the piston rod 1080 relative to the flange portion 1070. Wings of 1089 and struts of 1078 may be configured to interact in a similar manner regardless of whether the piston rod 1080 is rotated clockwise or counterclockwise, thus allowing bidirectional rotation of the piston rod 1080 to move the piston rod 1080 from a “primed” position to a “delivered” position. As shown in more detail in Figure 4X, each wing 1089 may have a rounded shape to allow ease of rotation in one direction, and the expansion of a wing 1089 after a detent 1078 may place the wing 1089 in a position relative to the detent 1078 that greatly resists or prohibits rotation in the opposite direction. The detent 1078 may have any suitable contour configured to assist the unidirectional movement of a wing 1089 by the detent 1078.

[0192] Advantageously, the various piston rod configurations 1080 described in this document may allow the modeling, molding and/or manufacturing of one part (e.g., piston rod 1080) or two parts (e.g., piston rod 1080 and flange part 1070) in order to achieve various objectives — for example, controlling the desired piston rod movement and assembly, reducing user error, preventing piston rod kickback, and minimizing a number of different parts that need to be manufactured and handled to assemble the device 1050.

[0193] In some embodiments, as seen in Figures 4Y-4Z, the device 1050 may include a pair of plunger rods in one kit, interchangeable with a single actuating portion 1082 or coupled to separate actuating portions 1082. For example, referring initially to Figure 4Y, the device 1050 may include a first plunger rod 1080A that is substantially similar to the plunger rod 1080 shown and described above, except for the differences explicitly noted in this document. The first plunger rod 1080A may include a rod 1081A that has a defined longitudinal length A between a distal end of the actuating portion 1082 and a tip 1083A. As described in detail below, the longitudinal length A can define a priming distance for moving the piston rod 1080A relative to the flange part 1070 for the priming device 1050. The tip 1083A can have a flat and/or planar interface that can be configured to inhibit the engagement of the stop 1062 when the first piston rod 1080A is received within the body 1060.

[0194] Now, with reference to Figure 4Z, the device 1050 may additionally include a second plunger rod 1080B which is substantially similar to plunger rod 1080. The second plunger rod 1080B may include a rod 1081B which extends distally from the actuating portion 1082 and which has a defined longitudinal length B between a distal end of the actuating portion 1082 and a tip 1083B. The tip 1083B is substantially similar to the tip 1083A described above. The longitudinal length B of rod 1083B is relatively greater than the longitudinal length A of rod 1081A and may define a dosing delivery distance for moving plunger rod 1080A relative to the flange portion 1070 to deliver a dose from the device 1050.

[0195] The first piston rod 1080A can be configured to prime the device 1050 in response to the translation of the rod 1081A through the collar 1072 and into the body 1060 (see Figures 1A-1B). In this case, the tip 1083A can contact and push the stop 1062 distally by the priming distance. It should be understood that the priming distance of the device 1050 can be controlled based on a longitudinal length size A of the first piston rod 1080A. After priming the device 1050, the first piston rod 1080A can be removed from the body 1060 and the flange part 1070 without the retraction stop 1062 due to a flattened interface of the tip 1083A. Therefore, the stop 1062 can remain in a fixed position relative to the body 1060 after the retraction of the first piston rod 1080A.

[0196] The second plunger rod 1080B can be configured to deliver a dose from the device 1050 in response to the translation of rod 1081B through the collar 1072 and into the body 1060 (see Figures 1A-1B), after the priming step described above using rod 1081A. In this case, tip 1083B can contact and push stop 1062 distally by the dosing delivery distance. It should be understood that the dosing delivery distance of the device 1050 can be controlled based on a longitudinal length size B of the second plunger rod 1080B. The dosing delivery distance can be substantially equal to the length difference between rod 1081B and rod 1081A.

[0197] Figures 5A-5C depict another exemplary delivery device 1200 according to further embodiments of the present disclosure. The device 1200 includes a body 1220 and a flange portion 1240 with a proximal collar 1242, in which an inner collar 1260 may be disposed. Together, the proximal collar 1242 and the inner collar 1260 can form a locking component for the device 1200. A plunger rod 1280 can pass through the inner collar 1260 and the flange portion 1240 to the body 1060. The plunger rod 1280 can share a longitudinal geometric axis with a central geometric axis of the proximal collar 1242 and the inner collar 1260 and can have an actuating portion 1282 dimensioned and configured to fit (e.g., snap or otherwise) within the inner collar 1260.

[0198] Device 1200 may be, for example, an injection device, such as a syringe, for dispensing a predetermined volume of a formulated pharmaceutical substance. Generally, device 1200 may share size, capacity, material, priming, assembly, manufacture, operation, or usage characteristics with device 1050 or with other delivery devices disclosed herein. As with device 1050, device 1200 may be configured for ease of use and may include one or more features that assist a user by providing tactile, auditory, or visual feedback (for example, using any of the features described elsewhere herein).

[0199] The body 1220 may have any or all of the same characteristics as, for example, the body 1060 of the device 1050, or as any syringe body known in the art. For example, in some embodiments, the body 1220 may be pre-filled or pre-filled (e.g., fillable or pre-filled with a pharmacological substance prior to assembly, packaging, sterilization and/or shipment of the device 1200 to users). In some embodiments, a stop 1222 may be configured to be inserted into the body 1220 and may be configured to contain a predetermined volume of a formulated pharmacological substance within the body 1200, between the stop 1222 and an expulsion end 1224.

[0200] The flange part 1240 may be of any size and/or shape suitable for closing, partially closing, covering, or partially covering one end of the body 1220 opposite the expulsion end 1224 and/or for supporting and holding the plunger rod 1280 in place within the body 1220. In some embodiments, the flange part 1240 may share some features with the flange part 1070 of the device 1050. For example, the flange part 1240 may include a distal collar 1244 configured to engage with the body 1220 and hold the flange part 1240 in place relative to the body 1220. For example, the distal collar 1244 may include a shoulder 1245 that may slide over a body flange 1226, to hold the flange part 1240 in place. In alternative embodiments, the protrusion 1245 of the distal collar 1244 may be made of a flexible or semi-flexible material, so that it can fit into place over the flange of the body 1226. In other embodiments, the distal collar 1244 or another portion of the flange part 1240 may be adhered, molded, or otherwise affixed to the body 1220 or may engage with the body 1220 by means of a friction fitting.

[0201] In some embodiments, the flange portion 1240 may include one or more flanges 1246, which may be sized and configured to assist a user in holding the device 1200 and/or expelling a formulated pharmacological substance from the device 1200. In some embodiments, as depicted in Figures 1A-1E, the flange portion 1240 may include two flanges 1246 opposing each other and extending perpendicularly from a longitudinal dimension of the device 1200. In some embodiments, the flange portion 1240 may include other arrangements of a flange or flanges, such as four flanges, or a circumferential flange extending radially outward from a central longitudinal geometric axis of the device 1200. In some embodiments, the flange portion 1240 may extend radially outward from a central longitudinal geometric axis of the device 1200 further than a circumference of the body. 1220. In such embodiments, the flange portion 1240 can support the device 1200 if the device 1200 is placed on a surface, can prevent the device 1200 from rolling on a flat surface, and/or can allow the device 1200 to be picked up more easily.

[0202] In some embodiments, the flange portion 1240 and the inner collar 1260 can be dimensioned and configured to serve as a locking component in the device 1200, for example, limiting and/or directing the rotational and longitudinal movement of the piston rod 1280. The proximal collar 1242 of the flange portion 1240 can be dimensioned and configured to accept part of the inner collar 1260, while blocking the protrusions 1262 from moving distally until the inner collar 1260 is rotated to a particular position. In turn, the inner collar 1260 can be sized and configured to receive part or all of an actuating portion 1282 of the piston rod 1280. As shown in Figures 5A-5C, the proximal collar 1242, the inner collar 1260, and the actuating portion 1282 can all generally have cylindrical shapes; in alternative embodiments, each of the proximal collar 1242, the inner collar 1260, and the actuating portion 1282 can have any suitable size or shape that allows the actuating portion 1282 to fit (e.g., nesting) within the inner collar 1260 and the inner collar 1260 to fit within the proximal collar 1242.

[0203] The plunger rod 1280 and the inner collar 1260 can generally be rotatable about a shared central longitudinal geometric axis (e.g., in one direction or in both directions). In addition, both the plunger rod 1280 and the inner collar 1260 can be movable along the central longitudinal geometric axis, for example, in a distal direction to prime the device 1200 and/or deliver a volume of pharmacological substance from the distal end 1224 of the body 1220. The actuating portion 1282 of the plunger rod 1280 may include a distal geometry that, when the actuating portion 1282 is moved distally to the inner collar 1260, interfaces with the inner collar 1260 to prevent proximal (e.g., outward) movement of the plunger rod 1280 from the inner collar 1260. For example, the actuating portion 1282 may include a distal wedge-shaped portion which, when it passes a distal portion of the inner collar 1260, expands distally from the inner collar 1260 such that the actuating portion 1282 can no longer move freely relative to the inner collar 1260.

[0204] The flange portion 1240 may include cavities, such as slots 1248, into which the protrusions 1262 of the inner collar 1260 may slide when the inner collar 1260 is rotated to a particular position. As with the slots 1074 of the device 1050, the slots 1248 may have a depth dimension parallel to a longitudinal geometric axis of the device 1200 and the depth of the slots 1248 may correspond to a distance the plunger rod 1280 must move distally in order to push the stop 1222 towards the expulsion end 1224, and dispense a predetermined volume of formulated pharmaceutical substance from the body 1220 to the expulsion end 1224.

[0205] In some embodiments, the device 1200 may have additional features. For example, in some embodiments, a plunger rod neck 1280 may have a geometry complementary to a flange opening 1240 that restricts the extent and direction that the plunger rod 1280 can rotate or move longitudinally, similar to the neck 1084 and opening 1073 of the device 1050. For example, the rotation and/or longitudinal movement of the plunger rod 1280 may be restricted based on the priming, priming, and/or drug delivery steps during the use of the device 1200. As another example, the plunger rod 1280 may be prevented from being pulled or retracted out of the body 1220 at any point during priming or use of the device 1200.

[0206] In a contemplated method of using the 1200 device, the 1200 device may be filled with a predetermined volume of pharmacological substance. The predetermined volume of pharmacological substance may be greater than a volume of pharmacological substance suitable for delivery to a patient. In some embodiments, the 1200 device (e.g., 1220 body) may contain a predetermined volume of pharmacological substance and an air bubble (not shown) that must be removed before delivery of the pharmacological substance to a patient. In some embodiments, the 1200 device may be a pre-filled syringe. In order to prime the device 1200 (e.g., by removing an air bubble if present and ensuring that an adequate volume of the pharmacological substance is delivered to a patient), a user may push the actuating portion 1282 of the plunger rod 1280 into the inner collar 1260. A geometry of the actuating portion 1282 may interact with the inner collar 1260 (e.g., a distal wedge or clip of the actuating portion 1282 may expand on a distal side of the inner collar 1260) to secure the actuating portion 1282 in and/or to the inner collar 1260 and to prevent recoil of the plunger rod 1280. At this point, the device 1200 may be in a “primed” state. Subsequently, the inner collar 1260 can be rotated around a longitudinal geometric axis until the protrusions 1262 are longitudinally aligned with the slots 1248. At this point, the device 1200 can be in a “delivery” state. To deliver a predetermined volume of pharmacological substance from the device 1200, the inner collar 1260, together with the actuating portion 1282 and the plunger rod 1280, can then be moved distally until the protrusions 1262 abut a distal end of the slots 1248. The distance traveled by the plunger rod 1280 in this step can push the stop 1222 distally by a distance necessary to dispense the predetermined volume of pharmacological substance from the expulsion end 1224 of the device 1200.

[0207] Referring now to Figures 6A-6E, views of a delivery device 1300 and component parts are depicted. The delivery device 1300 includes a locking component comprising a distal flange part 1340 and a proximal flange part 1360, a plunger rod 1380 and a body 1320. The distal flange part 1340 and the proximal flange part 1360 each include flanges (1346 and 1366, respectively). The flanges 1366 of the proximal flange part 1360 may optionally include a texture 1365. The distal flange part 1340 includes a channel 1341 that may allow the distal flange part 1340 and the body 1320 to be slidably mounted. The proximal flange portion 1360 includes a clip 1364 that can allow the proximal flange portion 1360 and the distal flange portion 1340 to be movably fixed to each other, so that they can still be rotated relative to each other around a longitudinal geometric axis of the delivery device 1300 (see, for example, Figures 6D and 6E). The proximal flange portion 1360 includes clips 1362 that border a central opening 1368 through which the plunger rod 1380 can pass. The plunger rod 1380 includes an actuating portion 1382, which may optionally include a texture 1381. The plunger rod 1380 further includes a distal neck shape 1384, a proximal neck shape 1387, and a proximal stop 1386 having a cavity 1385, all of which are configured to interface with the distal flange portion 1340 and the proximal flange portion 1360 in a plurality of configurations to allow controlled priming and delivery of a predetermined volume of a pharmacological substance using the delivery device 1300. The plunger rod 1380 further includes a distal tip 1383 at a distal end of a rod 1389, where the tip 1383 is configured to interface with the stop 1322. The tip 1383 may have any suitable size, shape, and mode of fastening, securing or pushing the stop 1322, as described in relation to, for example, the tip 1083 of the piston rod 1080. As with the rod 1081, the rod 1389 may have any size and configuration suitable to fit within the body 1320. In some embodiments, the step 1389 may be dimensioned and configured to provide sufficient size (e.g., thickness), stability and/or rigidity to reduce the likelihood of undesirable bending, oscillation or breakage.

[0208] Body 1320 (depicted in Figures 6D and 6E) may have any or all of the same characteristics as, for example, body 1060 of device 1050, or as any syringe body known in the art. For example, in some embodiments, body 1320 may be pre-fillable or pre-filled. A stop 1322 may be configured to be inserted into body 1320 and may be configured to contain a predetermined volume of a formulated pharmacological substance within body 1320, between the stop 1322 and an expulsion end 1324.

[0209] The delivery device 1300 may be, for example, an injection device, such as a syringe, for delivering a predetermined volume of a formulated pharmaceutical substance. Generally, the delivery device 1300 may share size, capacity, material, priming, assembly, or manufacturing characteristics with the device 1050, device 1200, or other delivery devices disclosed herein. As with devices 1050 and 1200, the delivery device 1300 may be configured for ease of use and may include one or more features that assist a user by providing tactile, auditory, or visual feedback (e.g., textures 1365, 1381, other textures, labels, colors, or tactile or auditory feedback, or using any of the other features described herein). As with devices 1050 and 1200, these features are optional, and one or more of these features may be combined to improve ease of use.

[0210] The proximal flange portion 1360 and the distal flange portion 1340 may be of any size and/or shape suitable to serve as a locking component in the delivery device 1300, to close, partially close, cover, or partially cover one end of the body 1320 opposite the expulsion end 1324, and/or to support and hold the plunger rod 1380 in place within the body 1320. In some embodiments, the proximal flange portion 1360 and the distal flange portion 1340 may each include one or more flanges, which may be sized and configured to assist a user in holding the device 1300 and/or expelling a formulated pharmacological substance from the expulsion end 1324. In some embodiments, as depicted in Figures 6A-6E, the flange portions 1360, 1340 may each include two flanges. 1366, 1346, respectively, where each pair of flanges is opposite each other and extending perpendicularly from a longitudinal dimension of the device 1300. In general, other arrangements of a flange or flanges, such as a flange on each of the flange parts 1360, 1340, are possible. Each of the flange parts 1340, 1360 may extend radially outward from a central longitudinal geometric axis of the device 1300 beyond a circumference of the body 1320, for example, to support the device 1300 if the device 1300 is placed on a surface, to prevent the device 1300 from rolling on a flat surface and/or to allow the device 1300 to be picked up more easily.

[0211] Flange parts 1360 and 1340 can, in combination, form a central opening with a changeable size and/or shape depending on the relative position of the proximal flange part 1360 and the distal flange part 1340. For example, in the configuration depicted in Figure 6D, the proximal flange part 1360 and the distal flange part 1340 can combine to form an opening sized and configured to allow distal passage of the distal neck portion 1384 of the piston rod 1380, but to block passage of the proximal neck portion 1387. In the second configuration depicted in Figure 6E (for example, where flanges 1346 and 1366 are aligned), the central opening formed by flange parts 1360 and 1340 can be sized and configured to allow distal passage of the proximal neck portion 1387. The stop The proximal flange 1386 may be of a size and shape that is too large to pass through the central opening formed by the flange parts 1360 and 1340 in any combination. In some embodiments, the distal flange 1340 may be mounted with the body 1320 and the piston rod 1380 such that the distal flange 1340 is not movable relative to the body 1320 and not rotatable relative to the piston rod 1380. The proximal flange 1360 may, in contrast, be mounted on the distal flange 1340 (and body 1320) such that it is rotatable about a longitudinal geometric axis relative to the distal flange 1340, body 1320, and piston rod 1380, which may pass through the central opening 1368. Specifically, the proximal flange 1360 can be rotatable relative to the distal flange 1340 from a first configuration in which the flanges 1346 and 1366 are offset from each other (see Figure 6D), to a second configuration in which the flanges 1346 and 1366 overlap each other (see Figure 6E). One skilled in the art will understand that in alternative embodiments, the distal flange 1340 can be rotatable relative to other parts of the device 1300, while the proximal flange 1360 may not be rotatable. In still other embodiments, both the proximal flange 1360 and the distal flange 1340 can be assembled with the body 1320 and the piston rod 1380 so that both are rotatable relative to other components of the device 1300.

[0212] The clips 1362 of the proximal flange portion 1360 can project and be angled towards the opening 1368. In a pre-use configuration (pictured in Figure 6D), the clips 1362 can be compressed by the plunger rod 1380. They can be positioned on the proximal flange portion 1360 so that, after distal movement of the plunger rod 1380 so that the distal neck portion 1384 passes through the opening 1368, they expand inward to abut the sides of the distal neck portion 1384. Once the clips 1362 expand in this way, they can block proximal movement of the plunger rod 1380, for example, to prevent return of the plunger rod (see, for example, Figure 7C). A cavity 1385 can be positioned in the proximal stop 1386 for each clip 1362, so that when the plunger rod 1380 is moved distally to the body 1320 to the most desired extension, each clip 1362 can fit into a cavity 1385.

[0213] Figures 7A-7F depict an exemplary method of using the device 1300, according to aspects of the present disclosure. In a pre-use configuration depicted in Figure 7A, the device 1300 may contain a volume of a pharmacological substance between the stop 1322 and the expulsion end 1324. The flange parts 1340 and 1360 may be in a pre-use configuration wherein the flanges 1346, 1366 are offset from each other. The plunger rod 1380, which may abut or be mounted on the stop 1322, may be partially inserted into the body 1320 through the flange parts 1340, 1360. The proximal flange part 1360 may be prevented from rotating about the longitudinal geometric axis of the syringe due to the geometries of the plunger rod 1380 and the flange part 1360. In a priming step depicted in Figure 7B, the plunger rod 1380 may be moved longitudinally further into the body 1320 until distal movement is blocked by the abutment of the proximal neck portion 1385 against a surface of the proximal flange part 1360. For example, a user may press the actuating portion 1382 toward the proximal flange part 1360. In some embodiments, the device 1300 may be held in an inverted position during this In this step, to ensure that the air trapped in the body 1320 can be expelled through the expulsion end 1324, as the stop 1322 is pushed distally by the plunger rod 1380. In the “primed” configuration, the distal neck portion 1384 can be disposed in the proximal opening 1368 of the flange portion 1360. Furthermore, as depicted in Figure 7C, once the priming step is interrupted, the clips 1362 can be released from their compressed configuration so that they can expand inward and abut one side of the distal neck portion 1384. Since the distal neck portion 1384 can be comparatively narrower than the plunger rod portion 1380 previously disposed in the opening 1368, the expansion of the clips 1362 can prevent proximal movement (e.g., recoil) of the rod. piston 1380.

[0214] As depicted in Figure 7D, the device 1300 may be in a primed configuration. In a delivery priming step depicted in Figure 7E, the proximal flange part 1360 may be rotated about a longitudinal geometric axis to align flanges 1366 and flanges 1346 and to alter (e.g., enlarge) a shape of the central opening formed by the combined openings of the proximal flange part 1360 and the distal flange part 1340. To do this, a user may grasp and twist the proximal flange part 1360. In some embodiments, it may be possible to twist the proximal flange part in either direction to align flanges 1366 and flanges 1346. In other embodiments, the proximal flange part 1360 may be rotatable in only one direction. In some embodiments, once flanges 1366 and flanges 1346 are aligned (as shown, for example, in Figure 7E), further rotation of the piston rod 1080 relative to the flange part 1070 can be stopped, for example, by the clip 1362 touching flange 1346. Thus, the device 1300 can be locked in a ready-to-dispense configuration. As depicted in Figure 7F, in a delivery step, the plunger rod 1380 can be moved longitudinally further into the body 1320. For example, a user can press the actuating portion 1382 distally until each of the clips 1362 enters a cavity 1385 in a proximal stop 1386, and/or until the proximal stop 1386 touches a proximal surface of the proximal flange portion 1360. The delivery step can ensure that a predetermined volume of a pharmacological substance within the body 1320 is dispensed from the device 1300.

[0215] In some embodiments, after each successive step in the use of the device 1300, a user may be prevented from repeating a step and/or reversing one or more steps. For example, geometries of, for example, plunger rod 1380 and the combined openings of proximal flange part 1360 and distal flange part 1340 may prevent a user from pulling the plunger rod 1380 proximally (e.g., out of) the body 1320, the rotating plunger rod 1380, the rotating proximal flange part 1360 preventively (e.g., before completion of the priming step shown in Figures 7B and 7C), and/or the excessively rotating flange part 1360 during a delivery priming step (e.g., shown in Figure 7E).

[0216] Figures 8A-8G depict another exemplary delivery device 1400 and component parts. The delivery device 1400 includes a plunger rod 1480, a locking component 1460, a flange portion 1440, and a body 1420. The plunger rod 1480 includes an actuating portion 1482 and a protrusion 1484. The locking component 1460 may be a rotary alignment component that is configured to partially or fully enclose the plunger rod 1480 and includes three connected channels 1462, 1464, 1468 sized and configured to allow passage of the protrusion 1484. The flange portion 1440 includes a proximal collar 1442 that has a channel 1447 in which the tabs 1461 of the locking component 1460 They can be fitted in a sliding manner, a distal collar 1444 including a channel 1445 into which a flange 1421 of the body 1420 can fit (for example, it can be mounted in a sliding manner) and flanges 1446.

[0217] Body 1420 (depicted in Figures 8D and 8E) may have any or all of the same characteristics as, for example, body 1060 of device 1050, or as any syringe body known in the art. For example, in some embodiments, body 1420 may be pre-fillable or pre-filled. A stop 1422 may be configured to be inserted into body 1420 and may be configured to contain a predetermined volume of a formulated pharmacological substance within body 1420, between the stop 1422 and an expulsion end 1424.

[0218] The delivery device 1400 may be, for example, an injection device, such as a syringe, for delivering a predetermined volume of a formulated pharmaceutical substance. Generally, the delivery device 1400 may share size, capacity, material, priming, assembly, or manufacturing characteristics with the device 1050, device 1200, device 1300, or with other delivery devices disclosed herein. As with other devices disclosed herein, the delivery device 1400 may be configured for ease of use and may include one or more features that assist a user by providing tactile, auditory, or visual feedback, using any of the features described elsewhere herein.

[0219] The locking component 1460 can be of any size and/or shape suitable to assist in controlling the proximal and distal movement of the plunger 1480 in the device 1400.

[0220] The flange portion 1440 may be of any size and shape suitable for closing, partially closing, covering, or partially covering one end of the body 1420 opposite the expulsion end 1424 and/or for supporting and holding the locking component 1460 and the plunger rod 1480 relative to the body 1420. For example, the proximal collar 1442 and channel 1447 may be sized and configured to contain the locking component 1460, and the distal collar 1444 and channel 1445 may be sized and configured to contain a flange 1421 of the body 1420, so that the locking component 1460 is held stationary relative to the body 1420. Furthermore, the locking component 1460 may be sized and configured to contain the plunger rod 1480 within the body 1420 and to limit the movement of the rod. The piston 1480 is related to the body 1420. The flange portion 1440 may include one or more flanges 1446, which may be sized and configured to assist a user in holding the device 1400 and/or expelling a formulated pharmacological substance from the expulsion end 1424. In some embodiments, as depicted in Figures 8A-8E, the flange portion 1440 may include two flanges 1446, opposite each other. In general, other arrangements of one or more flanges, such as one flange or three flanges, are possible. The flange portion 1440 may extend radially outward from a central longitudinal geometric axis of the device 1400 beyond a circumference of the body 1420, for example, to support the device 1400 if the device 1400 is placed on a surface, to prevent the device 1400 from rolling on a flat surface, and/or to allow the device 1400 to be picked up more easily.

[0221] Channels 1462, 1464, 1468 in the locking component 1460 together form a path through which the protrusion 1484 can travel, to allow controlled movement of the plunger rod 1480. A first channel 1462 may allow sufficient distal movement of the plunger rod 1480 to prime the device 1400. A second channel 1464 may allow movement of the plunger rod between a "primed" state and a "delivery" state. Channel 1464 may have a path that requires rotation of the plunger rod 1480 around a longitudinal geometric axis of the device 1400 (as opposed to distal movement of the plunger rod 1480), so that the probability of the plunger rod 1480 being accidentally or unintentionally moved to a "delivery" state can be reduced. Channel 1464 can provide a path of any suitable length (corresponding to any suitable angle of rotation of the plunger rod 1480) to ensure proper separation between the "primed" and "delivery" states. A third channel 1468 can allow sufficient distal movement of the plunger rod 1480 to dispense a predetermined volume of pharmacological substance from the device 1400.

[0222] One or more of each channel 1462, 1464, 1468 may include one or more retainers, as shown in Figures 8F and 8G. For example, a cross-sectional view of the locking component 1460 in Figure 8F shows an interior of channel 1464 that has a small retainer 1491 arranged on one side. Figure 8G depicts two larger retainers 1492, 1493 in channels 1462, 1464, respectively. Each detent can provide resistance to the movement of protrusion 1484 through channels 1462, 1464, and/or 1468 to provide auditory feedback and/or to prevent unintentional movement of protrusion 1484. In some embodiments, detents 1491, 1492, 1493 may be angled on one side to allow passage of protrusions 1484 in one direction but not the other. Detents such as those shown in Figures 8F and 8G may be suitable for inclusion in any device disclosed herein, as well as in device 1400.

[0223] Figures 9A-9E depict an exemplary method of using device 1400, in accordance with aspects of the present disclosure. In a pre-use configuration depicted in Figure 9A, the device 1400 may contain a volume of a pharmacological substance between the stop 1422 and the expulsion end 1424. The plunger rod 1480 may be partially inserted into the body 1420 so that the protrusion 1484 of the plunger rod 1480 is disposed in a proximal end portion of the channel 1462. In a priming step depicted in Figure 9B, the plunger rod 1480 may be moved longitudinally further into the body 1420 until distal movement is blocked by the abutment of the protrusion 1484 against a distal end of the channel 1462. For example, a user may press the actuating portion 1482 distally through the locking component 1460. In some embodiments, the device 1400 may be held in an inverted position during this In this step, to ensure that the air trapped in the body 1420 can be expelled, the stop 1422 is pushed distally by the piston rod 1480. In the "primed" configuration, depicted in Figure 9C, the protrusion 1484 of the piston rod 1480 can be disposed at a first end of the channel 1464.

[0224] In a delivery priming step depicted in Figure 9D, the plunger rod 1480 can be rotated about a longitudinal geometric axis so that the protrusion 1484 is moved from a first end of the channel 1464 to a second end of the channel 1464. For example, a user can grasp and twist the actuating portion 1482 of the plunger rod 1480. The device 1400 can then be in a ready-to-dispense configuration, where the protrusion 1484 is disposed at a proximal end of the channel 1468. As depicted in Figure 9E, in a delivery step, the plunger rod 1480 can be moved longitudinally further into the body 1420. For example, a user can press the actuating portion 1482 distally until the protrusion 1484 It borders with a distal end of channel 1468. The delivery step can ensure that a predetermined volume of a pharmacological substance within the body 1420 is distributed from the device 1400.

[0225] In some embodiments, after each successive step in the use of the device 1050, a user may be prevented from repeating a step and/or reversing one or more steps. For example, geometries of, for example, plunger rod 1480, protrusion 1484 and/or channels 1462, 1464, 1468 may prevent a user from pulling the plunger rod 1480 proximally (e.g., out of) the body 1420.

[0226] Figures 10A-10C depict an exemplary method of assembling the device 1400. As depicted in Figure 10A, the flange part 1440 can be slidably mounted onto the body 1420 so that the flange 1421 fits into the channel 1445 and the collar 1444 partially surrounds the body 1420. As depicted in Figure 10B, the locking component 1460 can be slidably mounted onto the flange part 1440 so that the tabs 1461 rest within the channels 1447 and the locking component 1460 abuts the proximal collar 1442. As depicted in Figure 10C, the plunger rod 1480 can then be inserted into the combined locking component 1460, flange part 1440 and body 1420, so that the protrusion 1484 is located within channel 1462 of body 1460.

[0227] Figures 10D-10G, 11A-11E and 12A-12D depict a variation in a configuration and method for using device 1400 and to avoid redundancy will not be described in great detail. Figures 10D-10G depict an alternative method of mounting device 1400, in which the locking component 1460 includes an opening 1463 through which the plunger rod 1480 can fit. In this embodiment, the channels within the locking component 1460 (e.g., channels 1462, 1468) can be closed at a proximal and distal end to prevent return or overinsertion of the plunger rod 1480 relative to the body 1420. As depicted in Figure 10E, the plunger rod 1480 can be partially inserted into the body 1420, and the flange portion 1440 can be slidably mounted onto the body 1420 so that the flange 1421 fits into the channel 1445 and the collar 1444 partially surrounds the body 1420. As depicted in Figure 10F, the locking component 1460 can be mounted onto the plunger rod 1480 so that the protrusion 1484 is disposed within one of the channels in the locking component 1460. As depicted in Figure 10G, the component of The locking component 1460 can then be mounted on the flanged part 1440 so that it is disposed in the channel 1447. The locking component can be affixed to the flanged part 1440 in any suitable manner (e.g., using clips, adhesive, a friction fitting, a dovetail connection, etc.). Figures 12A-12D depict a close-up view of the protrusion 1484 moving through the channels of the locking component 1460, according to the method of use shown in Figures 11A-11E.

[0228] Figures 13A and 13B depict another exemplary delivery device 1500 and a method of assembling said delivery device, according to further embodiments of the present disclosure. The device 1500 includes a piston rod 1580, a locking component in the form of a flange part 1540 and a body 1520. To assemble the device 1500, the piston rod can be inserted into the body 1520 (for example, as shown in Figure 13A), so that it confines or fastens to a stop 1522 in the body 1520, and the flange part 1540 can be slidably mounted onto 1521, for example, by sliding a channel 1541 into a flange 1521 of the body 1520 (for example, as shown in FIG. 13B). An opening 1543 may allow the flanged part 1540 to be mounted on the body 1520 around the piston rod 1580. It is contemplated that, depending on the size, shape and structure of each component of the device 1500, alternative mounting methods are possible.

[0229] The delivery device 1500 may be, for example, an injection device, such as a syringe, for delivering a predetermined volume of a formulated pharmaceutical substance. Generally, the delivery device 1500 may share size, capacity, material, priming, assembly, or manufacturing characteristics with the device 1050, device 1200, device 1300, or with other delivery devices disclosed herein. As with other devices disclosed herein, the delivery device 1500 may be configured for ease of use and may include one or more features that assist a user by providing tactile, auditory, or visual feedback, using any of the features described elsewhere herein.

[0230] Figures 14A-14F depict another view of the device 1500 and a method for using the device 1500. As shown in Figure 14A, the plunger rod 1580 may include an actuating portion 1582, a proximal stop 1588, a proximal neck portion 1586, and a distal neck portion 1584. The body 1520 may have any or all of the same features as, for example, the body 1060 of the device 1050, or as any syringe body known in the art. For example, in some embodiments, the body 1520 may be pre-filled or pre-filled. The stop 1522 can be configured to be inserted into the body 1520 and can be configured to contain a predetermined volume of a formulated pharmacological substance within the body 1520, between the stop 1522 and an expulsion end 1524.

[0231] The flange portion 1540 may be of any size and shape suitable for partially closing, covering, or partially covering one end of the body 1520 opposite the expulsion end 1524 and/or for supporting and holding the piston rod 1580 in the body 1520. An opening 1542 may have a size and shape configured to allow passage of the piston rod 1580 in two different configurations. The distal neck portion 1584 and the proximal neck portion 1586 may have similar shapes, but may be rotationally offset from each other (e.g., so that once the distal neck portion 1584 passes through the opening 1542, the plunger rod 1580 must be rotated about a longitudinal geometric axis to allow part of the neck 1587 to pass through). The distal neck portion 1584 may include, for example, a tapered distal side, which may aid in guiding the plunger rod 1580 so that the distal neck portion 1584 can pass through the opening 1542. This may increase the ease of, for example, a priming step.

[0232] Figure 14A depicts a pre-use configuration of the device 1500. In such a configuration, the device 1500 may contain a volume of a pharmacological substance between the stop 1522 and the expulsion end 1524. The plunger rod 1580 may be partially inserted into the body 1520 so that the distal neck portion 1584 is positioned proximally to the flange portion 1540. In a priming step depicted in Figure 14B, the plunger rod 1580 may be moved longitudinally further into the body 1520 until distal movement is blocked by the abutment of the proximal neck portion 1586 against the opening 1542 (as shown in Figure 14C). For example, a user can press the actuating portion 1582 until the distal portion of the neck passes through the opening 1542. In some embodiments, the device 1500 can be held in an inverted position during this step, to ensure that air trapped in the body 1520 can be expelled as the stop 1522 is pushed distally by the plunger rod 1580. In the "primed" state, depicted in Figure 14D, the proximal neck portion 1586 can be disposed against a surface of the flange portion 1540.

[0233] In a delivery priming step depicted in Figure 14D, the plunger rod 1580 can be rotated about a longitudinal geometric axis so that the shape of the proximal neck portion 1586 aligns with the opening 1542. For example, a user can grasp and twist the actuating portion 1582 of the plunger rod 1580. The device 1500 can then be in a ready-to-dispense configuration. As depicted in Figure 14E, in a delivery step, the plunger rod 1580 can be moved longitudinally further into the body 1520. For example, a user can press the actuating portion 1582 distally until the proximal stop 1588 confines with a surface of the flange portion 1540. The delivery step can ensure that a predetermined volume of a pharmacological substance within the body 1520 is dispensed from the device 1500.

[0234] In some embodiments, after each successive step in the use of the device 1500, a user may be prevented from repeating a step and/or reversing one or more steps. For example, geometries of, for example, plunger rod 1580, distal neck portion 1584, proximal neck portion 1586 and opening 1542 may interact with each other to prevent a user from pulling the plunger rod 1580 proximally (e.g., out of) the body 1520.

[0235] Further variations in the locking components, dosage control components and the like will now be described. Figures 15A-23C depict exemplary plunger rod dials according to other embodiments of the present disclosure. For example, Figure 15A represents a plunger rod 1600 having an actuating portion 1610. The actuating portion 1610 may have a shape generally corresponding to a flange portion 1640. The plunger rod 1600 may be rotatable relative to the flange portion 1640 and/or a device body. A device may be in a suitable configuration for delivering a desired quantity of a pharmacological substance when, for example, a plunger rod shape 1610 is generally aligned with the shape 1640 (as shown, for example, the top view of Figure 15A). As another example, Figure 15B depicts an actuating portion 1610’ with a grooved side, to allow ease of rotation of the plunger rod 1600’ relative to the flanged part 1640 and/or a syringe rest. Figure 16A depicts an actuating portion 1610” with a grooved side, again to allow ease of rotation of the plunger rod 1600. Figure 16B depicts an exemplary combination of the actuating portion 1610’’ with the device 1500. One skilled in the art will understand that any of the actuating portions or other features described herein may be combined with devices described herein.

[0236] Figure 17 depicts an exemplary plunger rod and dial according to other embodiments of the present disclosure. An actuating portion 1612 can be dimensioned and configured to fit into a collar 1642 of a flanged part 1640 in only one particular configuration. The depth of the collar 1642 can correspond to, for example, a distance that the plunger rod 1600 must travel to dispense a predetermined volume of a pharmacological substance from a drug delivery device. In one embodiment, the actuating portion 1612 can be moved distally until it touches the collar 1642 and then rotated until its shape matches the shape of the collar 1642 so that it can be pushed into the collar 1642 in a delivery step. Figures 18A and 18B depict another exemplary plunger rod and dial, which combine exemplary features enabling precision dose delivery. The plunger rod may include, for example, protrusions 1684 and 1682, which may each fit through an opening 1641' into a flange portion 1680 in a particular configuration. Each of the protrusions 1682 and 1684 may correspond to a distance required to deliver a desired volume of a pharmacological substance from a device and/or prime the device. The actuating portion 1650 may include a raised portion 1652, which may assist a user in twisting the plunger rod relative to the flange portion 1680.

[0237] Figures 19A and 19B depict a top view of a flange portion 1740 and a piston rod 1720. The flange portion 1740 and the piston rod 1720 may have a cross-sectional shape permitting limited rotation of the piston rod 1720 relative to the flange portion 1740 in a single direction. For example, the flange portion 1740 may have internal protrusions that may interact with an irregular cross-sectional shape of the piston rod 1720 to resist a first portion of the piston rod 1720 as it rotates past the internal protrusions and to stop a second portion of the piston rod 1720 when it comes into contact with the internal protrusions.

[0238] Figure 20 represents an exemplary flange portion 1750 with a well 1760 having clips 1762. A piston rod actuating portion 1780 can be pushed distally into the well 1760 until the clips 1762 overlap the actuating portion 1780, to hold the actuating portion 1780 in place and, for example, to prevent piston rod recoil. The piston rod includes a distal protrusion 1781 and a proximal protrusion 1783, each of which is dimensioned to fit through an opening 1764 when the piston rod is rotated to a particular position. The distal protrusion 1781 includes a conical distal side, which can help guide the plunger rod to the position required to advance the plunger rod distally, so that the distal protrusion 1781 passes through the opening 1764. This can increase the ease of, for example, a priming step. In some embodiments, a well height 1760 and/or actuating portion 1780 may correspond to a height that a plunger rod must travel to dispense a predetermined volume of a pharmacological substance. Thus, a device can be primed when the actuating portion 1780 confines with a proximal side of the well 1760 and can deliver a predetermined volume of a pharmacological substance as the actuating portion 1780 travels distally to the well 1760.

[0239] Figure 21 represents an exemplary device 1800 with a piston rod 1820 and a complementary flange portion 1840. The piston rod 1820 may include, for example, protrusions 1844, 1846 that have an angular or wedge shape, corresponding to the shape of one or more openings 1842 in the flange portion 1840. The wedge or angular shapes of the protrusions 1844, 1846 and openings 1842 may be sufficient to resist the distal movement of the piston rod 1820 when a protrusion 1844 or 1846 confines with one side of the opening 1842, but may have the capacity to pass through each other given sufficient force. The resistance provided by the abutment of the protrusions 1844, 1846 against the sides of the openings 1842 may be sufficient to indicate to a user that a specific step in the use of the device 1800 has been completed. A user may then apply sufficient force to move the plunger rod 1820 past the resistance and proceed to the next step (e.g., from a completed priming step to a ready delivery step).

[0240] As described elsewhere, any of the devices disclosed in this document can be combined with labels, auditory feedback and/or tactile feedback in the form of symbols (for example, in Figure 22 depicted as lock and unlock symbols 1850, 1852, divisions 1856 in the actuation portion 1854). The rotation of a plunger rod can also be accompanied by a “click” type sound.

[0241] Figures 23A-23C depict another exemplary combination of components in a delivery device. For example, a piston rod actuating portion 1650 may include, for example, ribbed sides and a raised portion 1652, to assist in twisting the actuating portion. A device with these features may include, for example, openings 1842 and corresponding angled protrusions 1844, 1846 (described in relation to Figure 21).

[0242] Figures 24A-24E depict another exemplary delivery device 1900 and a method for using the device 1900. The device 1900 may include an actuating portion 1940 and a locking component 1980 depicted on a piston rod 1920. The piston rod 1240 may abut a stop 1912 in a body 1910. The locking component 1980 may be rotatable relative to the piston rod 1920. In a pre-use configuration depicted in Figure 24B, the locking component 1980 may be in a first position relative to the piston rod 1920 and the flange portion 1960. In a priming step depicted in Figure 24C, the piston rod 1920 may be moved longitudinally further in the body. 1910, until distal movement is blocked by the abutment of the locking component 1980 against a recess 1962 in the flange portion 1960. For example, a user can press the actuating portion 1940 distally toward the flange portion 1960. In a delivery priming step depicted in Figure 24D, the locking component 1980 can be rotated so that a shorter dimension of the locking component 1980 faces the flange portion 1960. The recess 1962 can be curved to allow ease of rotation of the locking component 1980. A distance between the locking component 1980 and the flange portion 1960 after the locking component 1980 is rotated can correspond to a distance that the plunger rod 1920 can move to dispense a predetermined volume of a pharmacological substance from the device 1900. As depicted In Figure 24E, during a delivery step, the plunger rod 1920 can be moved longitudinally further into the body 1910 until the rotated locking component 1980 contacts the flange portion 1960 in a second position. For example, a user can press the actuating portion 1940 distally until the protruding locking component contacts the flange portion 1960. The delivery step can ensure that a predetermined volume of a pharmacological substance within the body 1910 is dispensed from the device 1900.

[0243] Figures 25A-25E depict another exemplary delivery device 2000 and a method for using the delivery device 2000. A plunger rod 2080 of the device 2000 may include threads 2100, corresponding to internal threads (not depicted) in a flanged portion 2062. As depicted in Figure 25A, the plunger rod 2080 may be rotatable relative to other portions of the device 2000. The plunger rod 2080 may also include a protrusion 2082 located proximally from the threads 2100 (see, for example, Figure 25B), which may correspond to an opening 2062 in a flanged portion 2062, such that the plunger rod 2080 must be in a particular configuration and position to allow the protrusion 2082 passes into and/or through flange part 2060. In a pre-use configuration depicted in Figure 25C, threads 2100 and protrusion 2082 can be positioned proximal to flange part 2060. In a priming step, the plunger rod 2080 can be rotated relative to the internal threads of flange part 2060 until threads 2100 pass through flange part 2060 and/or protrusion 2082 prevents further rotation or distal movement of plunger rod 2080. In a delivery priming step, protrusion 2082 can be moved toward opening 2062. In a delivery step, protrusion 2082 can be moved through opening 2062 to further advance plunger rod 2080. and to dispense a predetermined volume of a pharmacological substance within the body of the device 2000.

[0244] Figures 26A-26E depict a delivery device 2200 which has other variations in the dosing control components. For example, the device 2200 includes a plunger rod 2280 with one or more clips 2284, each of which can be configured to slide distally into a channel 2242 of a flanged portion 2240 and, once it has slid distally, to resist proximal sliding out of the channel 2242 (e.g., to prevent or resist recoil of the plunger rod 2280). The flanged portion 2240 may further have a second channel 2244 and a third channel 2246, through which each of the clips 2284 can slide in the priming and dosing delivery steps as previously described. Alternatively, as shown in Figure 26B, the channel 2242' may have an open proximal end through which a protrusion 2284' may move, allowing proximal and/or distal movement of a plunger rod 2280' relative to the flange portion 2240'. As depicted in Figure 26C, in a pre-use configuration, clips 2284 can be arranged proximally to channels 2242 of the flange portion 2240. In a priming step, the plunger rod 2280 can be moved distally into a device body 2200 until clips 2284 move into channels 2242 and abut a distal end of channels 2242. In a delivery priming step, the plunger rod 2280 can be rotated relative to the flange portion 2240. In a delivery step, the plunger rod 2280 can be moved further distally into a device body 2200 to deliver a predetermined volume of the pharmacological substance from the device 2200.

[0245] In other embodiments, as shown in Figures 26F-26G, a flange portion 2240" may include one or more projections 2246" arranged within a collar 2242". In the present example, the collar 2242" may include a pair of projections 2246" extending radially into an inner surface of the collar 2242" and in opposite directions relative to each other. For example, the projections 2246" may be arranged approximately 180 degrees apart from each other. It should be understood that the flange portion 2240" may include additional and/or fewer projections 2246" than those shown and described herein without departing from the scope of this disclosure. The flange portion 2240" may be configured to engage a plunger rod 2080" in response to the plunger rod 2280" receiving projections 2246".

[0246] As seen in Figure 26G, a piston rod 2280" may include an actuating element 2284" defined by a proximal end 2282" and a distal end 2283"'. The piston rod 2280" may include a series of channels along opposite sides of the actuating member 2284"', such as, for example, a first channel 2286"', a second channel 2288"', and a third channel 2290"' positioned between the proximal end 2282"' and the distal end 2283"'. The first channel 2286"' is displaced from the third channel 2290"' and connected to the third channel 2290"' by the second channel 2288"' positioned between them. As described in detail below, the first channel 2286"' may define a longitudinal and axial priming path of the piston rod 2280"', the second channel 2288" can define a circumferential path of the plunger rod 2280" and the third channel 2290" can define a longitudinal and axial dose termination path. It should be understood that an opposite surface and/or side of the actuating member 2284" (not shown) includes a substantially similar series of interconnected first channel 2286", second channel 2288" and third channel 2290" as seen in FIGO. 26G. In the present example, the first channel 2286" and the third channel 2290" can be aligned parallel to each other.

[0247] The first channels 2286'', the second channels 2288'' and the third channels 2290'' can be sized, shaped and configured to receive at least one of the pair of projections 2246''. With the plunger rod 2280'' coupled to the flange portion 2240'', the projections 2246'' can project and slide through the first channels 2286'', second channels 2288'' and third channels 2290'' to prepare and deliver a dose from the device 2200 (Figure 26A) as described in detail above. In some embodiments, the first canals 2286" may have an open end at the proximal end 2282" through which the projections 2246" may be received. In some embodiments, the first canals 2286" may have a closed proximal end and the projections 2246" may be at least partially flexible and/or deformable so that the projections 2246" may be configured to flex radially outward upon being received at the proximal end of the first canals 2286". In other embodiments, the first canals 2286" may have a beveled, chamfered and/or tapered end to facilitate the orientation projections 2246" towards the second canals 2288". In this case, the angled end can inhibit retraction (e.g., proximal movement) of the plunger rod 2280" relative to the flange portion 2240"'. A longitudinal length of the first channels 2286" can define an axial priming path (e.g., a priming amount or extent) that is configured to facilitate proximal and/or distal movement of the plunger rod 2280" relative to the flange portion 2240"'. For example, projections 2246" can be arranged at a proximal end of the first channels 2286" and proximally of the second channels 2288" when the device 2200 is in an assembled state. In a priming step, the piston rod 2280" can move distally relative to the flange part 2240" until the projections 2246" are positioned within the second channels 2288" and at a distal end of the first channels 2286"'. The second channels 2288" can define a circumferential path of the piston rod 2280"'.

[0248] In a delivery priming step, the plunger rod 2280" can be rotated relative to the flange portion 2240" to translate the projections 2246" laterally through the circumferential path of the second channels 2288" and toward a dose termination path defined by the third channels 2290"'. In some embodiments, the plunger rod 2280" and/or the flange portion 2240" can be configured to generate user feedback (e.g., tactile, audible, visual, etc.) when the device 1050 is in the delivery priming step. In a delivery step, the plunger rod 2280" can move distally into a device body 2200 to deliver a controlled volume of substance by translating the projections 2246" through the third channels 2290"'. A longitudinal length of third channels 2290" may define a dosing delivery path (e.g., a dosing quantity). It should be understood that the axial priming path (length of first channels 2286") may vary relative to the dosing delivery path (length of third channels 2290"). In other embodiments, the plunger rod 2280" may include additional and/or fewer channels along the actuating member 2284" (e.g., corresponding to a number of projections 2246" on the flange portion 2240"), or have various other relative channel configurations than those shown and described in this document.

[0249] Figures 27A-27H depict an exemplary delivery device 2300 and method for using the delivery device 2300. An actuating portion 2350 may also serve as a locking component of the device 2300. The actuating portion 2350 may be slidingly coupled to the plunger rod 2380 in two configurations, by means of a channel 2352. As depicted in Figure 27B, one side of the actuating portion 2350 may include a channel 2354. The depth of the channel 2354 may correspond to a distance that a plunger rod may move to dispense a predetermined volume of a pharmacological substance, once the device 2300 has been primed. As depicted in Figure 27C and Figure 27D, in a pre-use configuration, the actuating portion 2350 can be mounted on the plunger rod 2380 so that a flat side of the actuating portion 2350 faces a collar 2360 of the device 2300. In a priming step, the actuating portion 2350 can be used to move the plunger rod 2380 distally until the flat side 2356 of the actuating portion 2350 confines with a proximal side of the collar 2360. To prepare for a dosing delivery step, the actuating portion 2350 can be removed from the plunger rod 2380 and can be rotated or inverted and reassembled with the plunger rod 2380 so that the channel 2354 faces the collar 2360, as depicted in the Figures. 27F and 27G. In a dosage delivery step, the actuating portion 2350 can be used to push the plunger rod 2380 further distally until a proximal end of the collar 2360 confines with an inner end of the channel 2354. This movement of the plunger rod 2380 may be sufficient to dispense a predetermined dose of a pharmacological substance from the device 2300.

[0250] Figures 28A-28C depict an exemplary delivery device 2400 and method for using the delivery device 2400. The delivery device 2400 may include features substantially similar to those shown and described above, so similar reference numbers are used to identify similar components. As shown in Figure 28A, the delivery device 2400 may include a removable clip 2402 coupled to the body 1060 in a position distal to the flange part 1070. The removable clip 2402 may be an obstruction and/or locking component configured to inhibit movement of the flange part 1070 relative to the body 1060. The removable clip 2402 is selectively removable so that the removable clip 2402 can be configured to disengage the body 1060 in response to manual actuation of the removable clip 2402.

[0251] By way of illustrative example, the removable clip 2402 may have a body that encloses an exterior of the body 1060 and is configured to selectively deform (e.g., break, tear, etc.) upon application of a force to it in order to decouple the removable clip 2402 from the body 1060. In other examples, the removable clip 2402 may have a flexible body that is configured to bend in response to an external radial force being applied to it, thus detaching the removable clip 2402 from the body 1060. By way of further example, the removable clip 2402 may have a body that is configured to selectively transition between a closed configuration that encapsulates a circumference of the body 1060 within it and an open configuration that allows removal of the body 1060 from the body of the removable clip 2402. The removable clip 2402 may include various other suitable sizes, shapes and/or configurations than those shown and described herein, without prejudice to the provisions of this document. to exclude from the scope of the present disclosure.

[0252] The delivery device 2400 may include a radial wall 1063 that extends laterally outward from an exterior of the body 1060, thus forming an obstruction along the body 1060. As seen in Figure 28A, the radial wall 1063 may be configured to inhibit distal translation of the removable clip 2402 along the body 1060. In some embodiments, the radial wall 1063 may be an additional component fixed to the body 1060, while in other embodiments, the radial wall 1063 may be formed integrally into the body 1060. Now, with reference to Figure 28B, the flange portion 1070 and the plunger rod 1080 may be configured to translate distally along the body 1060 for the priming delivery device 2400 upon removal of the removable clip 2402 from the body 1060. In this case, the piston rod 1080 may remain stationary relative to the flanged part 1070, as the combined assembly of the flanged part 1070 and the piston rod 1080 moves relative to the body 1060. In other embodiments, the piston rod 1080 may remain stationary as the flanged part 1070 translates distally along the body 1060 to the main delivery device 2400. For example, at least a portion of the flanged part 1070 may extend into the body 1060 (e.g., and behind the stop 1062) when priming the device 2400. In this case, the piston rod 1080 may be translated separately to deliver a dosage from the delivery device 2400.

[0253] With the flange portion 1070 translated from a proximal position (Figure 28A) to a distal position (Figure 28B), the delivery device 2400 can be in a primed position. It should be understood that the body 1060 can be configured to limit movement by the flange portion 1070 to a defined distance based on a radial wall location 1063, which can correspond to a priming distance of the delivery device 2400. Therefore, a priming distance of the delivery device 2400 can be controlled by adjusting a range of movement of the flange portion 1070 along the body 1060.

[0254] As seen in Figure 28C, the plunger rod 1080 can be translated distally relative to the body 1060 in response to the application of a distally directed force on the actuating portion 1082. In this case, the rod 1081 can move relative to the flanged portion 1070, causing the stop 1062 to move within the body 1060 to deliver a dose. It should be understood that an extent that the plunger rod 1080 translates relative to the flanged portion 1070 can define a dosing delivery distance of the delivery device 2400. The dosing delivery distance can be controlled based on a gap formed between the collar 1072 and the actuating portion 1082.

[0255] In other embodiments, as seen in Figures 28D-28F, the delivery device 2400 may additionally include a locking component, such as, for example, a removable rod 2404 coupled to the flange portion 1070. Referring specifically to Figure 28D, the removable rod 2404 may be received through a proximal end of the collar 1072, such as, for example, through one or more lateral openings (not shown) formed through the collar 1072. The removable rod 2404 may be configured to inhibit the movement of the piston rod 1080 relative to the flange portion 1070, such as, for example, preventing the receiving of the actuating portion 1082 in the collar 1072. The removable rod 2404 may be selectively removable and configured to disengage the collar 1072 by manual actuation of the removable rod 2404. It should be understood that the Delivery device 2400 may include various other locking components in addition to and/or in place of the removable rod 2404, such as, for example, a pin, a tab, a bar and the like.

[0256] For example, referring now to Figure 28E, the flange part 1070 and the plunger rod 1080 (e.g., rod 1081 and actuating portion 1082) can be configured to translate distally along the body 1060 to the main delivery device 2400 in response to the removal of the removable clip 2402 from the body 1060. The plunger rod 1080 can remain stationary relative to the flange part 1070 as the assembly of the flange part 1070 and the plunger rod 1080 moves relative to the body 1060. With the flange part 1070 translated from a proximal position (Figure 28D) to a distal position (Figure 28E), the delivery device 2400 can be in a primed position. It should be understood that body 1060 can be configured to limit movement by the flange portion 1070 to a defined distance based on a radial wall location 1063 along body 1060, which may correspond to a priming distance of the delivery device 2400.

[0257] As seen in Figure 28F, the removable rod 2404 can be disengaged from the collar 1072 so that the plunger rod 1080 is no longer inhibited from moving distally relative to the flange portion 1070. The actuating portion 1082 can be translated to the collar 1072 to move the rod 1081 and the stop 1062 within the body 1060 to deliver a dose. An extension that the plunger rod 1080 translates relative to the flange portion 1070 can define a dosing delivery distance of the delivery device 2400.

[0258] In other embodiments, as seen in Figures 28G-28I, the removable clip 2402 may be omitted entirely so that the delivery device 2400 may include a single obstruction and/or blocking component, i.e., rod 2404. In this case, the flange portion 1070 may be fixed relative to the body 1060. With the actuating portion 1082 positioned proximally to the rod 2404, the delivery device 2400 may be primed in response to the piston rod 1080 translating distally towards the flange portion 1070 until it encounters the rod 2402. It should be understood that the flange portion 1070 and/or rod 2404 may be configured to inhibit the distal translation of the piston rod 1080 relative to it, in the absence of an application of a force directed distally to it. In other examples, the delivery device 2400 may include a locking component positioned between the actuating portion 1082 and the rod 2404 (e.g., removable clip 2404) to inhibit distal movement of the plunger rod 1080.

[0259] Therefore, a priming distance of the delivery device 2400 can be defined by a distance between the distal end of the actuating portion 1082 and the rod 2404 when the delivery device 2400 is in an assembled, pre-primed state (Figure 28G). With the actuating portion 1082 engaged against the rod 2402, as seen in Figure 28H, the delivery device 2400 can be in a primed state. The rod 2402 can be removed from the collar 1072 to allow for further translation of the piston rod 1080 distally relative to the flange portion 1070. As shown in Figure 28I, a dose can be delivered from the delivery device 2400 in response to the collar 1072 receiving the actuating portion 1082. It should be understood that a longitudinal deviation of a distal end of the actuating portion 1082 and an inner surface of the collar 1072 can be determinant for a dosage delivery distance. Consequently, an extent (e.g., the dosage delivery distance) that the piston rod 1080 translates relative to the flange portion 1070 can define a dosage volume delivered by the delivery device 2400.

[0260] In additional embodiments, as shown in Figures 28J-28L, the delivery device 2400 may include a fixed clip 2406 attached to the body 1060 at a location relatively distal to the removable clip 2402. The fixed clip 2406 may be an obstruction and/or blocking component positioned in contact with the removable clip 2402, such that the fixed clip 2406 may be configured to inhibit the movement of the removable clip 2402 along the body 1060. With the flange portion 1070 positioned proximal to the removable clip 2402, the fixed clip 2406 may be further configured to inhibit the movement of the flange portion 1070 when the removable clip 2402 is positioned between them.

[0261] Now, with reference to Figure 28K, the flange part 1070 can be configured to translate distally along the body 1060 to the priming delivery device 2400 by removing the removable clip 2402 from the body 1060. In this case, the plunger rod 1080 can remain stationary relative to the flange part 1070 as the plunger rod assembly 1080 and the flange part 1070 move towards the fixed clip 2406. With the flange part 1070 translated from a proximal position (Figure 28J) to a distal position (Figure 28K) engaged against the fixed clip 2406, the delivery device 2400 can be in a primed position. It should be understood that body 1060 can be configured to limit movement by flange part 1070 to a defined distance, which may correspond to a priming distance of the delivery device 2400.

[0262] As seen in Figure 28L, the plunger rod 1080 can be translated distally relative to the body 1060 in response to the application of a distally directed force on the actuating portion 1082. The rod 1081 can move relative to the flange portion 1070, causing the stop 1062 to move within the body 1060 to deliver a dose. It should be understood that an extent that the plunger rod 1080 translates relative to the flange portion 1070 can define a dosing delivery distance of the delivery device 2400. The dosing delivery distance can be controlled based on a position of the fixed clip 2406 along the body 1060.

[0263] In other embodiments, the delivery device 2400 may include a sleeve 2408 extending distally from the flange portion 1070, as shown in Figure 28 million. The sleeve 2408 may be attached to a distal end of the flange portion 1070 and/or be an integral part of the flange portion 1070, thus forming a unitary structure. The sleeve 2408 can be disposed within the body 1060 and includes a distal end 2410. The sleeve 2408 can define a lumen that is sized and shaped to receive the rod 1081 when the plunger rod 1080 is coupled to the flange part 1070. As described in more detail in this document, the sleeve 2408 can be configured to move within a lumen of the body 1060 in response to the flange part 1070 translating along an exterior of the body 1060.

[0264] The glove 2408 may additionally include a locking component, such as, for example, a second protrusion 2412 formed along an inner surface of the glove 2408, such that the second protrusion 2412 extends at least partially into the lumen defined by the glove 2408. In this embodiment, the second protrusion 2412 is positioned relatively proximal to the distal end 2410. In other embodiments, the glove 2408 may include various other suitable locking components in place of the second protrusion 2412, such as, for example, a dimensioned, shaped, and configured opening to receive the protrusion 1085.

[0265] Referring specifically to Figure 28M, the protrusion 1085 can extend radially outward from the rod 1081 and be positioned proximally relative to the second protrusion 2412 when the plunger rod 1080 is received through the flange part 1070 and the sleeve 2408. To prime the delivery device 2400, the plunger rod 1080 can be translated distally relative to the flange part 1070 and sleeve 2408 until the protrusion 1085 contacts the second protrusion 2412. It should be understood that the extent to which the plunger rod 1080 translates relative to the sleeve 2408 can define a priming distance of the delivery device 2400. The priming distance can be controlled based on the position of the protrusion 1085 and of the second protrusion 2412 in relation to each other.

[0266] With the protrusion 1085 engaged against the second protrusion 2412 and a distal end of the actuating portion 1082 received against an inner surface of the collar 1072, the plunger rod 1080 can be coupled to the sleeve 2408 and the delivery device 2400 can be in a primed state, as shown in Figure 28N. The actuating portion 1082 can be fully received within the collar 1072, and the rod 1081 can be locked into the sleeve 2408. Consequently, further translation of the plunger rod 1080 can provide translation of the flange portion 1070 and the sleeve 2408 relative to the body 1060. For example, as seen in Figure 280, the plunger rod 1080 and the flange portion 1070 can be translated distally relative to the body 1060 in response to the application of a distally directed force on the actuating portion 1082. The rod 1081 can move relative to the body 1060, causing the stop 1062 to move within the body 1060 to administer a dose.

[0267] The distal end 2410 can translate towards the ejection end 1064 as the plunger rod 1080 and the flange part 1070 move distally until they meet the fixed clip 2406. It should be understood that the extent to which the plunger rod 1080 and the flange part 1070 translate can define a dosing delivery distance of the delivery device 2400. The dosing delivery distance can be controlled based on a position of the fixed clip 2406 along the body 1060.

[0268] In other embodiments, as seen in Figures 28P-28Q, the delivery device 2400 may include an obstruction and/or blocking component in the form of a pull tab 2420. The pull tab 2420 may include a body 2422 having a circular cross-section defining a central opening 2424. The body 2422 may be formed of various flexible materials, including, for example, plastic, rubber and the like. As described in more detail in this document, the pull tab 2420 may be frangible and/or deformable in response to an application of force on the body 2422. The pull tab 2420 may additionally include a gripping feature 2426 that extends outward from the body 2422 and is configured to facilitate manual actuation of the pull tab 2420. As seen in Figure 28P, the gripping feature 2426 may be integrally formed with the body 2422, such that the application of a radially outward force (e.g., a pulling force) on the gripping feature 2426 may cause the body 2422 to deform (e.g., tear, break, etc.), as shown in Figure 28Q.

[0269] Now, with reference to Figure 28R, the pull tab 2420 can be fixed to the flange part 1070 along a proximal end of the collar 1072. The pull tab 2420 can be arranged over the collar 1072 so that the flange part 1070 is separated from the actuating portion 1082 by the pull tab 2420 positioned between them. The rod 1081 can be received through the central opening 2424 and into the collar 1072 when the body 2422 is fixed to the collar 1072. The pull tab 2420 can be configured to inhibit the translation of the actuating portion 1082 to the collar 1072. A thickness and/or width of the body 2422 can be dimensioned so that a diameter of the central opening 2424 is smaller than a diameter of the actuating portion 1082 to prevent the actuating portion 1082 from passing through the pull tab 2420.

[0270] The delivery device 2400 can be primed in response to the translation of the piston rod 1080 distally relative to the flange part 1070 until it encounters the body 2422, as seen in Figure 28S. It should be understood that an extension of the piston rod 1080 translated relative to the flange part 1070 can correspond to a priming distance of the delivery device 2400. The priming distance can be controlled based on a thickness of the body 2422, thus varying a relative distance between the actuating portion 1082 and the collar 1072. With the actuating portion 1082 engaged against the body 2422, the gripping feature 2426 can be actuated to remove (e.g., break, tear, pull, etc.), pull the guide 2420 from the collar 1072. In this case, the body 2422 can be deformed (see Figure 28Q) and disengaged from the flange part 1070, thus allowing a further translation of the piston rod 1080 distally relative to the flange part 1070.

[0271] As seen in Figure 28T, the actuating portion 1082 can be received within the collar 1072 in response to the application of a distally directed force on the actuating portion 1082. The rod 1081 can move relative to the body 1060, causing the stop 1062 to move within the body 1060 to administer a dose. It should be understood that an extension that the plunger rod 1080 translates relative to the collar 1072 can correspond to a dosage delivery distance of the delivery device 2400. The dosage delivery distance can be controlled based on a thickness of the pull tab 2420, thus varying a relative distance between the actuating portion 1082 and a distal (e.g., lower) end of the collar 1072.

[0272] In additional embodiments, as shown in Figures 28U-28X, the delivery device 2400 may include a removable cover 2430 coupled to the plunger rod 1080. The removable cover 2430 may include a body 2432 defining a cavity 2434 that is dimensioned and shaped to receive at least a portion of the plunger rod 1080 therein (e.g., actuating portion 1082). The removable cover 2430 may include an opening along a lower (e.g., distal) wall of the body 2342 to receive the rod 1081. In some embodiments, the removable cover 2430 may be fixed to the actuating portion 1082, while in other embodiments the body 2342 may be coupled directly to the rod 1081. The removable cover 2340 may be an obstruction and/or blocking component configured to increase a cross-sectional profile of the actuating portion 1082 to inhibit movement of the piston rod 1080 relative to the flange portion 1070 and, more specifically, to prevent translation of the actuating portion 1082 to the collar 1072.

[0273] Now, with reference to Figure 28V, the plunger rod 1080 can be configured to translate distally relative to the flange portion 1070 to the priming delivery device 2400 until a lower wall of the body 2432 meets a proximal end of the collar 1072. The removable cap 2430 can inhibit the actuating portion 1082 from being received within the collar 1072 due to at least a portion of the body 2342 being disposed between the actuating portion 1082 and the collar 1072. With the plunger rod 1080 translated from a proximal position (Figure 28U) to a distal position (Figure 28V) with the body 2432 engaged against the collar 1072, the delivery device 2400 can be in a primed position. It should be understood that an extension that the piston rod 1080 translates in relation to the flange part 1070 may correspond to a priming distance of the delivery device 2400. The priming distance can be controlled based on a size of the removable cover 2430 and/or a position of the removable cover 2430 in relation to the piston rod 1080. For example, in other embodiments, a lower wall of the body 2432 may be fixed to a proximal portion of the rod 1081 positioned relatively distal to the actuating portion 1082. In this case, a priming distance of the delivery device 2400 may be reduced in relation to that shown and described in this document, since the body 2432 may be positioned closer to the collar 1072. Consequently, the piston rod 1080 may need to move a shorter distance towards the removable cover 2430 to meet the collar. 1072.

[0274] As seen in Figure 28X, the removable cap 2430 can be detached from the plunger rod 1080 so that the actuating portion 1082 can be exposed from the body 2432. The plunger rod 1080 can be translated distally relative to the body 1060 and received within the collar 1072 in response to the application of a distally directed force on the actuating portion 1082. The rod 1081 can move relative to the flange portion 1070, causing the stop 1062 to move within the body 1060 to deliver a dose. It should be understood that an extension that the piston rod 1080 translates in relation to the flange part 1070 can correspond to a dosing delivery distance of the delivery device 2400. The dosing delivery distance can be controlled based on a removable cap attachment 2430 in relation to the actuating portion 1082 and/or rod 1081 as described above. Furthermore, a collar depth 1072 can be determinant of the dosing delivery distance so that a collar size 1072 can be adjusted accordingly to form various suitable dosing delivery distances.

[0275] For example, securing the removable cap 2430 so that a distal wall of the removable cap 2430 is positioned flush against a distal end of the actuating portion 1082 can increase the relative priming distance of the delivery device 2400 by providing a longer separation between the removable cap 2430 and the collar 1072. Consequently, the securing position of the removable cap 2430 can correspond to a shorter dosing delivery distance when translating the actuating portion 1082 to the collar 1072 after removing the removable cap 2420. Alternatively, securing the removable cap 2430 so that the distal wall of the removable cap 2430 is positioned distally from the distal end of the actuating portion 1082 can decrease the relative priming distance, thus providing a greater dosing delivery distance, since the actuating portion 1082 may require additional longitudinal translation to be fully primed. Received within collar 1072. It should be understood that the size and/or shape of the removable cap 2430 may vary to accommodate the various attachment positions described above.

[0276] In some embodiments, as shown in Figures 28W-28Z, the delivery device 2400 may include one or more tabs 2440 attached to the piston rod 1080, such as along the actuating portion 1082, rod 1081 and/or various other portions of the piston rod 1080. In the example, the delivery device 2400 includes a pair of tabs 2440 extending radially outward from a distal end of the actuating portion 1082. The tabs 2440 may be an obstruction and/or blocking component configured to increase a cross-sectional profile of the actuating portion 1082 to inhibit movement of the piston rod 1080 relative to the flange portion 1070 and, more specifically, to inhibit translation of the actuating portion 1082 into the collar. 1072. In some embodiments, the tabs 2440 can be selectively removed from the actuating portion 1082 by applying force to them. In other embodiments, the tabs 2440 can be compressible and configured to be pushed into the actuating portion 1082 in response to applying force to them. In both cases, the tabs 2440 can be configured to transition the actuating portion 1082 from an expanded profile (Figures 28W-28Y) to a compressed profile (Figure 28Z).

[0277] Now, with reference to Figure 28Y, the plunger rod 1080 can be configured to translate distally relative to the flange portion 1070 for the priming delivery device 2400 until the tabs 2440 meet a proximal end of the collar 1072. The tabs 2440 can inhibit the collar 1072 which receives the actuating portion 1082 on them. With the plunger rod 1080 translated from a proximal position (Figure 28W) to a distal position (Figure 28Y) with the tabs 2440 engaged against the collar 1072, the delivery device 2400 can be in a primed position. It should be understood that an extension that the piston rod 1080 translates in relation to the flange part 1070 may correspond to a priming distance of the delivery device 2400.

[0278] The priming distance can be controlled based on a size (e.g., thickness, width, height, etc.) of the guides 2440 and/or a position of the guides 2440 relative to the piston rod 1080. For example, in other embodiments, the pair of tabs 2440 can be fixed to an intermediate and/or proximal portion of the actuating portion 1082 or, alternatively, along the rod 1081. In this case, a priming distance of the delivery device 2400 can be increased and/or decreased, respectively, relative to that shown and described in this document.

[0279] As seen in Figure 28Z, the tabs 2440 can be compressed into the actuating portion 1082 by the collar 1072 by applying an inward pressing force (or, alternatively, decoupled from the actuating portion 1082 by applying an outward pulling force, a rotary engagement force or similar), so that this actuating portion 1082 can form a smaller cross-sectional profile. The plunger rod 1080 can be translated distally relative to the body 1060 and received within the collar 1072 in response to the application of a distally directed force on the actuating portion 1082. The rod 1081 can move relative to the flange portion 1070, causing the stop 1062 to move within the body 1060 to deliver a dose. It should be understood that an extension that the piston rod 1080 translates in relation to the flange part 1070 can correspond to a dosing delivery distance of the delivery device 2400. As described above, the dosing delivery distance can be controlled based on the position of the tabs 2440 in relation to the actuating portion 1082, a size (e.g., longitudinal depth) of the collar 1072, and the like. For example, a relative position of the tabs 2440 that increases a priming distance of the delivery device 2400 can correspond to a shorter dosing delivery distance, and a position of the tabs 2440 that corresponds to a reduced priming distance can provide a longer dosing delivery distance. In other examples, the plunger rod 1080 may include a second set of tabs (not shown) along the actuating portion 1082 that may define a dosing delivery distance based on a relative position of the tabs in relation to the tabs 2440.

[0280] Figures 29A-29C depict an exemplary delivery device 2500 and method for using the delivery device 2500. The delivery device 2500 may include features substantially similar to those shown and described above, so similar reference numbers may be used to identify similar components. As shown in Figure 29A, the delivery device 2500 may include a plunger rod 2580 comprising a first actuating portion 2502, a second actuating portion 2504, and a cam lever 2510. The first actuating portion 2502 may be coupled to the second actuating portion 2504 by one or more arms 2506. In the example, a pair of arms 2506 may be attached to the first actuating portion 2502 along a first end of the arms 2506, and the arms 2506 may be further coupled to the second actuating portion 2504 at a second end of the arms 2506 that is opposite the first end. The second actuating portion 2504 may be a rotating element including a proximal end 2505 and an opposite distal end having a joint 2508. The pair of arms 2506 may be coupled to the distal end of the second actuating portion 2504 at the joint 2508.

[0281] It should be understood that, when in a ready position, as seen in Figure 29A, the second actuating portion 2504 can be oriented so that the joint 2508 is positioned close to the first actuating portion 2502 relative to the proximal end 2505. A proximal end 1088 of the rod 1081 can be positioned adjacent to the joint 2508 at a distal end of the second actuating portion 2504. For example, the proximal end 1088 can be in contact with and/or abut the distal end of the second actuating portion 2504. In some embodiments, the rod 1081 can extend through a center of the first actuating portion 2502 and/or be positioned alongside the first actuating portion 2502. The second actuating portion 2504 can be configured to move relative to the first actuating portion 2502 and around the joint. 2508. The cam lever 2510 can be coupled to the second actuating portion 2504 in the joint 2508 and configured to move (e.g., rotate, turn, translate, etc.) the second actuating portion 2504 relative to the first actuating portion 2502. Therefore, it should be understood that the second actuating portion 2504 can be configured to move the rod 1081 relative to the body 1060 in response to the cam lever 2510 moving the second actuating portion 2504 relative to the first actuating portion 2502.

[0282] For example, referring to Figure 29A, the cam lever 2510 can be actuated by rotating the cam lever 2510 around the joint 2508, causing the second actuating portion 2504 to rotate around the joint 2508. The proximal end 2505 can be moved towards the first actuating portion 2502 in response to the second actuating portion 2504 rotating around the joint 2508. In this case, the proximal end 2505 can be moved towards the first actuating portion 2502. With the proximal end 2505 moved from a proximal position (Figure 29A) to a distal position (Figure 29B), the proximal end 1088 can be pushed distally, thus translating the rod 1081 relative to the body 1060 to the initial delivery device 2500. In other words, the rotation of The cam lever 2510 and/or the second actuating portion 2504 in relation to the first actuating portion 2502 can prime the delivery device 2500 by forcing the rod 1081 distally.

[0283] It should be understood that a travel length of the proximal end 2505 towards the first actuating portion 2502 can correspond to a priming distance of the delivery device 2500. In other words, a priming distance of the delivery device 2500 can be controlled by a longitudinal length of the second actuating portion 2504 between the proximal end 2505 and the joint 2508. In some embodiments, the first actuating portion 2502, the arms 2506 and/or the cam lever 2510 can inhibit further rotation of the second actuating portion 2504 after the plunger rod 2580 is moved from the ready position (Figure 29A) to the primed position (Figure 29B).

[0284] As seen in Figure 29C, the plunger rod 2580 can be translated distally relative to the body 1060 in response to the application of a distally directed force on the first actuating portion 2502 and the second actuating portion 2504. In this case, the cam lever 2510 can be pressed (e.g., pushed and/or pulled) distally to move the first actuating portion 2502 and the second actuating portion 2504 towards the flange portion 1070 until it encounters a proximal end of the collar 1072. The rod 1081 can move relative to the collar 1072, causing the stop 1062 to move within the body 1060 to deliver a dose. It should be understood that an extension of the translation of the piston rod 2580 relative to the flange part 1070 can correspond to a dosing delivery distance of the delivery device 2500. The dosing delivery distance can be controlled based on a gap formed between the collar 1072 and the cam lever 2510.

[0285] Figures 30-31 depict an exemplary delivery device 2600 that may include features substantially similar to those shown and described above, so that similar reference numbers are used to identify similar components. The delivery device 2600 may include a flange part 2670, a plunger rod 2680, and the body 1220. The flange part 2670 may include a conical collar 2672 that has a variable size and/or shape between a distal end and a proximal end. In the example, the tapered collar 2672 may have a larger cross-sectional profile (e.g., diameter) along a distal end adjacent to the flanges 1076 than at a proximal end adjacent to the slots 1074. The tapered collar 2672 may be configured to minimize an overall profile and/or weight of the delivery device 2600, minimizing a configuration of the flange portion 2670. In some embodiments, the flanges 1076 may have a reduced length to facilitate improved control and maneuverability of the flange portion 2670.

[0286] The piston rod 2680 may include an actuating portion 2682 that has a cross-sectional profile (e.g., diameter) that is relatively smaller than the tapered collar 2672 to facilitate receiving the actuating portion 2682 through it. Consequently, the actuating portion 2682 may be similarly configured to minimize an overall profile and/or weight of the delivery device 2600, minimizing a configuration of the actuating portion 2682. Furthermore, the piston rod 2680 may omit the inclusion of a textured and/or ribbed surface along the actuating portion 2682 to simplify an external appearance of the piston rod 2680.

[0287] Referring specifically to Figure 30, the actuating portion 2682 may additionally include a proximal end having an outer ring 2687, an inner surface 2688, and one or more openings 2689 formed through the inner surface 2688. In the example, the inner surface 2688 may be disposed within the outer ring 2687 and may have an angular profile that is radially inclined inward toward one or more openings 2689. The inner surface 2688 may be configured to define an interface for actuating the plunger rod 2680 (e.g., applying a distally directed force to the actuating portion 2682 by a user's finger). Although the plunger rod 2680 is shown as including a pair of openings 2689, it should be understood that in other embodiments additional and/or fewer openings 2689 may be included in the inner surface 2688.

[0288] In some embodiments, as seen in Figure 31, the plunger rod 2680 may include an outer ring 2687' which has a width that defines an outer surface disposed around the inner surface 2688. For example, an outer surface of the outer ring 2687' may be inclined inward toward the inner surface 2688 and openings 2689 and/or be transverse to the inner surface 2688. In the present example, the outer ring 2687' defines a flat outer surface that is substantially perpendicular to a longitudinal length of the actuating portion 2682. The increased width of the outer ring 2687' may provide additional surface area for a user of the device 1050 to contact when actuating the plunger rod 2680. It should be understood that a width of the outer ring 2687' may be greater and/or less than that shown and described in the present document, without departing from the scope of this disclosure.

[0289] Figures 32-33 depict an exemplary piston rod 2780 which may include features substantially similar to those of the piston rod 1080 shown and described above, so that similar reference numbers may be used to identify similar components. The piston rod 2780 may include an actuating portion 2782 having a proximal end defined by an outer ring 2787, an inner ring 2788, and one or more openings 2789. In the example, the inner ring 2788 may be disposed within the outer ring 2787 and may define at least one opening 2789. The outer ring 2787 may additionally define at least one opening 2789 positioned radially outward from the inner ring 2788. One or more of the openings 2789 may minimize the overall weight of the piston rod 2780, increase the molding manufacturability of the piston rod 2780 by providing nominal wall thicknesses for the actuating portion 2782, and more. Furthermore, the actuating portion 2782 may include a lateral protrusion 2786 that extends along a width of the distal end and is aligned with the protrusions 1086. The lateral edge 2786 may bifurcate into one or more openings 2789 defined by the outer ring 2787 and inner ring 2788. The lateral edge 2786 may be collinear with the protrusions 1086 to provide visual alignment and/or identification of the protrusions 1086 to a user of the plunger rod 2780.

[0290] As seen in Figure 33, with the piston rod 2780 received within the flange portion 1070 and body 1220, the side edge 2786 can be configured to improve movement identification by the piston rod 2780 relative to the flange portion 1070 from a proximal perspective of the device 1200. For example, the side protrusion 2786 can facilitate the identification of a relative position of the protrusions 1086 to the slots 1074 from a perspective proximal to the actuation portion 2782 during the use of the device 1200. In some embodiments, the piston rod 2780 may omit a textured and/or ribbed surface along the actuation portion 2782 to simplify the external appearance of the piston rod 2780.

[0291] Figure 34 depicts another exemplary delivery device 2800 according to an example of this disclosure. The delivery device 2800 may include features substantially similar to those of the delivery device 1050 and the delivery device 1200 shown and described above, so similar reference numbers are used to identify similar components. The delivery device 2800 may include a flange portion 2870, a piston rod 2880, and the body 1220. The flange portion 2870 may have a collar 2872 and a pair of flanges 2876 extending laterally outward from the collar 2872. The collar 2872 may have a narrow profile, as, for example, in relation to the collar 1072. Furthermore, the flanges 2876 may have a shortened length in relation to the flanges 1076. Consequently, the flange portion 2870 of the present example may generally have a narrow profile. The flange portion 2870 may additionally include a shoulder 2871 that may slide under or otherwise receive the body flange 1226 (Figure 35). The 2871 edge can be configured to hold the 2870 flange portion in place by means of sliding coupling of the 2870 flange portion to the 1220 body. As described in more detail below, the 2871 shoulder can be made of a flexible or semi-flexible material capable of forming a press-fit connection with the 1226 body flange.

[0292] The plunger rod 2880 may include an actuating portion 2882 having one or more protrusions 1086 along a proximal end and one or more extensions 1087 along a distal end. The actuating portion 2882 may have a diameter that is generally smaller than the actuating portion 1082 shown and described above. Therefore, it should be understood that the plunger rod 2880 and the flange portion 2870 may collectively form a narrow profile relative to a plunger rod 1080 and flange portion 1070 assembly. By providing a reduced profile, the delivery device 2800 may be configured to provide enhanced user control and maneuverability of the plunger rod 2880 and flange portion 2870 during use of the delivery device 2800.

[0293] In this embodiment, the protrusions 1086 may have a curvature configured to increase the grip, comfort and/or ergonomics of the plunger rod 2880 for a user of the delivery device 2800. A curvature of protrusions 1086 may have an outer concave configuration that tapers inward along a distal portion of protrusions. A proximal end of the actuating portion 2882 may additionally include a first ring 2887, an opening 2888, and a second ring 2889 positioned distally relative to the first ring 2887. The first ring 2887 may define a proximal interface of the actuating portion 2882, and the opening 2888 may be positioned in the center of the first ring 2887. The proximal interface defined by the first ring 2887 may be inclined toward the opening 2888 so that a proximal end of the actuating portion 2882 may be radially inclined inward. In some embodiments, the first ring 2887 may be sized, shaped, and configured to facilitate actuation of the plunger rod 2880 by defining a finger pad to receive a user's finger. The opening 2888 can be configured to maintain a nominal wall thickness of the actuating portion 2882 to facilitate the molding of the plunger rod 2880 during a manufacturing process of the delivery device 2800. The openings 2888 can further minimize the overall weight of the plunger rod 2880.

[0294] Referring again to Figure 34, the second ring 2889 may extend radially outward from an outer surface of the actuating portion 2882 and is positioned adjacent to the first ring 2887. The second ring 2889 may be configured to form a gripping feature along the actuating portion 2882 to increase control of the piston rod 2880, such as when rotating the piston rod 2880. The first ring 2887 may have a larger diameter than the actuating portion 2882, so that the finger pad formed by the first ring 2887 may have a larger cross-sectional profile than the actuating portion 2882. In some embodiments, the second ring 2889 may include a larger diameter than the actuating portion 2882 and be substantially similar to the first ring 2887. The piston rod 2880 The inclusion of a textured and/or ribbed surface along the actuating portion 2882 may be omitted to simplify the appearance of the piston rod 2880.

[0295] As seen in Figure 35, the actuating portion 2882 can be dimensioned to have a predetermined length C between a distal end of the protrusion 1086 and the hook or clip-shaped part 1087a of the extensions 1087. In some embodiments, the predetermined length C can be dimensioned according to the type and/or size of a syringe cap used with the delivery device 2800 (e.g., Ompi Alba ITC, Ompi Alba OVS, Gerresheimer TELC, silicone-free syringes, etc.). For example, the predetermined length C can be decreased and/or increased according to a lower and/or higher filling volume requirement, respectively, determined based on the syringe cap. Furthermore, the predetermined length C can be dimensioned to provide a full stroke of the piston rod 2880 in the flanged portion 2870 to ensure that a full dosage is delivered by the delivery device 2800. The predetermined length C can be further adjusted to provide one of a plurality of suitable dosage delivery distances for the delivery device 2800. The flanged portion 2870 may include additional features and/or components configured to allow a full stroke of the piston rod 2880.

[0296] For example, referring now to Figure 36, the flange portion 2870 may include one or more recesses 2875 formed along a proximally and distally located (lower) facing surface of the collar 2872. The recess 2875 may be dimensioned and/or shaped to form a recessed surface on the lower surface of the collar 2872. The recess 2875 may be configured to facilitate the receiving of the piston rod 2880 into the flange portion 2870 to allow a full stroke. In other words, the recess 2875 may provide increased space and/or clearance within the collar 2872 to receive one or more components of the piston rod 2880, such as, for example, the hook or clip-shaped portion 1087a of the extensions 1087.

[0297] In the present example, the delivery device 2800 can be configured to deliver a full dose onto the pair of protrusions 1086 in contact with a distal end (the bottom) of the slots 1074. The pair of extensions 1087 can be positioned adjacent to (but not in contact with) a lower surface of the collar 2872 when the protrusions 1086 contact the distal end of the slots 1074. That is, in some embodiments, the extensions 1087 can be positioned proximal to the lower surface of the collar 2872 so that the extensions 1087 do not come into contact with the lower surface when the plunger rod 2880 has reached the bottom and/or when a full dose has been delivered from the delivery device 2800. By forming a depression along the lower surface of the collar 2872, the recess 2875 can allow the actuating portion 2882 to translate distally relative to the collar 2872 to complete a full stroke of the plunger rod 2880 without extensions 1087 engaging or contacting the lower surface of the collar 2872. In some embodiments, the extensions 1087 can bend inward toward the recess 2875 in the hook or clip-shaped portions 1087a that meet the lower surface of the collar 2872, thus guiding the hook or clip-shaped portions 1087a into the recess 2875. It should be understood that an increased space formed by the recess 2875 can ensure that the extensions 1087 are not prevented from contacting the lower surface of the collar 2872 to complete the full stroke of the plunger rod 2880 and/or to deliver a full dose.

[0298] Referring again to Figure 36, the flange portion 2870 may additionally include one or more ribs 2874 configured to engage the body flange 1226 when the body 1220 is coupled to the flange portion 2870. The one or more ribs 2874 may be positioned adjacent to the shoulder 2871, for example, distally to the lower surface of the collar 2872 and proximally to the shoulder 2871. In some embodiments, the ribs 2874 may extend radially into an inner side wall of the flange portion 2870, while in other embodiments the ribs 2874 may extend outward from an inner upper wall of the flange portion 2870. In the present example, the ribs 2874 may extend radially inward at an angle to the inner side wall of the part. of flange 2870. It should be understood that ribs 2874 may be positioned and/or extend from several other suitable locations, and at several other suitable angles, within flange portion 2870 to engage body flange 1226.

[0299] In this embodiment, the ribs 2876 may be formed of a flexible and/or semi-flexible material (e.g., plastic, rubber, etc.) and configured to interact with the body flange 1226 after receiving the body 1220 within the flange portion 2870. By way of illustrative example, the ribs 2874 may be configured to flex and/or bend proximally towards a lower surface of the collar 2872 in response to the shoulder 2871 that receives the body flange 1226. The ribs 2874 may be operable to secure the body flange 1226 to the flange portion 2870 by applying a force directed distally thereto. Therefore, ribs 2874 can ensure a position (e.g., longitudinal, rotational, etc.) of the body 1220 relative to the flange part 2870 by engaging an upper/proximal surface of the body flange 1226, as the projection 2871 engages a lower surface of the body flange 1226. In other embodiments, additional and/or fewer ribs 2874 may be included to inhibit movement of the body flange 1226 and/or body 1220 relative to the flange part 2870.

[0300] Now, with reference to Figure 37, the flange part 2870 may include a textured and/or patterned interface 2878 along a lower surface facing away from the flanges 2876. The textured interface 2878 may include one or more protrusions, depressions, and/or various other features forming at least one of a plurality of patterns to improve grip, control, and/or ergonomics of the flange part 2870. In the example, the textured interface 2878 includes a plurality of semicircular protrusions of varying sizes. As shown in Figure 37, each interface 2878 may be concave when viewed from a radial center of the flange 2876. However, in alternative embodiments, one or more interfaces 2878 may be convex when viewed from the radial center of the flange 2876. As described in more detail below, the textured interface 2878 may include various other designs, features, and/or patterns along the underside (see Figures 41A-41D) of the flanges 2876. The flange portion 2870 may additionally include a pair of movable tabs 2877 positioned adjacent to the edge 2871 and along opposite sides of the opening 1073. The movable tabs 2877 may be formed of a flexible and/or semi-flexible material and may be configured to move relative to the collar 2872 and/or flanges 2876 in response to a force being applied thereto (e.g., by the body 1220).

[0301] Each movable flap 2877 can define an opening 2873 disposed between the movable flap 2877 and the flange 2876. Consequently, the movable flaps 2877 can be separated from the flanges 2876 by the opening 2873 formed between them. The openings 2873 can provide a gap and/or free space to accommodate the lateral movement of the movable flaps 2877 when receiving a radially directed outward force. For example, the movable tabs 2877 can be radially deflected outwards towards the flanges 2876 in response to the flange portion 2870 receiving the body 1220 through the opening 1073, thus altering the size and/or shape of the openings 2873. In this case, the movable tabs 2877 can bend outwards away from the opening 1073 until the body flange 1226 is received by the shoulder 2871. The movable tabs 2877 can be configured to bend inwards towards the body 1220 to return to an original configuration over the shoulder 2871 which fully receives the body flange 1226 thereon. In some embodiments, the movable tabs 2877 can fold towards the body 1220 to a substantially original configuration so that the movable tabs 2877 can remain at least partially compressed against the body 1220 to inhibit movement of the body 1220 relative to the flange portion 2870 to allow pressure to be continuously applied to the body 1220 to prevent slippage.

[0302] Referring again to Figure 37, the movable tabs 2877 can be configured to apply a radially inwardly directed force to the body 1220 (for example, with a radially inwardly directed material bias), thus forming a press-fit connection between the flanged part 2870 and the body 1220. Furthermore, the movable tabs 2877 can hold the body 1220 in a stabilized and fixed position relative to the flanged part 2870, thus coupling the flanged part 2870 to the body 1220. It should be understood that the openings 2873 can be included between the movable tabs 2877 and the flanges 2876 to reduce the force required to couple the body 1200 to the flanged part 2870. For example, the openings 2873 can be operable to reduce the force required to fit the body 1200 into the flanged part. flange 2870 requires a minimum force ranging from about 15 Newtons to about 25 Newtons, compared to a design that omits the openings 2873.

[0303] Figures 38A-40C show an illustrative method of using the delivery device 2800. As seen in Figure 38A, the delivery device 2800 can be pre-assembled with a distal portion of the actuating portion 2882 received within the collar 2872 and extensions 1087 received within and coupled to the openings 1094. With extensions 1087 coupled to the collar 2872 via openings 1094, it should be understood that the flanged portion 2870 can inhibit the proximal retraction of the actuating portion 2882. Consequently, disassembly of the piston rod 2880 from the flanged portion 2870 can be avoided. In this case, the delivery device 2800 can be primed by distal translation of the piston rod 2880 to the flange part 2870.

[0304] As seen in Figure 38B, the actuating portion 2882 can be translated distally relative to the flange portion 2870 until the protrusions 1086 meet a proximal end of the collar 2872. The piston rod 2880 can complete a priming process of the delivery device 2800 by means of protrusions that engage and/or abut the collar 2872. It should be understood that an extent to which the piston rod 2880 translates distally relative to the flange portion 2870 can correspond to a priming distance of the delivery device 2800. The priming distance can be controlled based on a longitudinal length of the protrusions 1086 and/or extensions 1087, thus varying a relative distance between the proximal end of the collar 2872 and a distal end of the protrusions. 1086.

[0305] As shown in Figure 38C, the flange portion 2870 can be rotated relative to the piston rod 2880, or vice versa, to move the protrusions 1086 relative to the collar 2872 until radial and longitudinal alignment with slots 1074 is achieved. Referring to Figures 39A-39B, the extensions 1087 can contact an inner surface 2872A of the collar 2872 as the piston rod 2880 rotates relative to the flange portion 2870. As seen in Figure 39D, with the hook or clip-shaped portion 1087a engaged against the inner surface 2872A, the extensions 1087 can be radially deflected inward by the collar 2872 until the piston rod 2880 is rotated to align the extensions 1087 with the Internal grooves 2879 of flange portion 2870. The internal grooves 2879 may define recesses formed along the internal surface 2872A. As seen in Figure 39C and Figure 39E, the internal grooves 2879 may be dimensioned and shaped to receive extensions 1087 therein. It should be understood that the collar 2872 may have a larger diameter in the internal grooves 2879 than along the internal surface 2872A, so that the extensions 1087 are configured to expand radially outward from a compressed configuration (Figures 39A-39B and Figure 39D) to an expanded configuration (Figure 39C and Figure 39E) when the extensions 1087 are moved into radial alignment with internal grooves 2879.

[0306] In other words, the extensions 1087 can be transitioned to a relaxed state when received within the internal grooves 2879 due to the additional space provided by the internal grooves 2879, as seen in Figure 39E. In some cases, feedback (e.g., tactile, auditory, etc.) can be generated in response to the extensions 1087 being received within the internal grooves 2879. The delivery device 2800 can be positioned in a dose delivery state so that additional actuation of the plunger rod 2880 can provide dose delivery. In some embodiments, the flanged part 2870 can be operable to generate user feedback (e.g., tactile, audible, etc.) by rotating the plunger rod 2880 relative to the flanged part 2870 to the main delivery device 2800.

[0307] As described in detail above and as seen in Figures 40A-40C, the opening 1073 may have a semicircular shape with one or more edges 2873 extending into the opening 1073. With the plunger rod 2880 coupled to the flange portion 2870, the rod 1280 may be received through the opening 1073. The rod 1280 may include a rounded side wall 2884 that is configured to interact with one or more edges 2873 as the plunger rod 2880 rotates relative to the collar 2872. For example, the rounded side wall 2884 may define a semicircular end along the rod 1280 that may contact the edges 2873 when the plunger rod 2880 is moved from the primed position (Figure 38B) to the dosing delivery position (Figure 38C). As described in detail above (Figures 4K-4X), it should be understood that the rod 1280 may have various shapes and/or configurations suitable for facilitating the movement (e.g., rotation) of the piston rod 2880 relative to the flange part 2870.

[0308] Now, with reference to Figure 38D, with protrusions 1086 aligned with slots 1074, the actuating portion 2880 can be translated distally relative to the collar 2872 to complete a full stroke of the piston rod 2880 in response to the application of a distally directed force on the actuating portion 2882. In this case, the rod 1280 can move relative to the flange portion 2870, causing the stop 1222 to move within the body 1220 to deliver a dosage. In this case, the protrusions 1086 can be received within the slots 1074, and the second ring 2889 can be positioned near a proximal end of the collar 2872. In other words, in some embodiments, the second ring 2889 does not contact the proximal end of the collar 2872. Furthermore, as described in more detail above, the recesses 2875 can receive extensions 1087 (Figure 36) upon completion of a full stroke of the plunger rod 2880. It should be understood that an extension in which the plunger rod 2880 translates relative to the flange portion 2870 can define a dosing delivery distance of the delivery device 2800. The dosing delivery distance can be controlled based on a longitudinal length of protrusions 1086 relative to the actuating portion 2882 and/or a depth of slots 1074 relative to the collar. 2872.

[0309] As seen in Figures 41A-41D, the delivery device 2800 may include several other flange parts 2870 having at least one of a plurality of textured interfaces on the flanges 2876. As merely an illustrative example, as seen in Figure 41A, an alternative exemplary flange part 2870A may include a textured interface 2878A on flanges 2876 comprising a plurality of circular protrusions and/or depressions arranged in an annular array relative to each other. As seen in Figure 41B, another exemplary flange part 2870B may include a textured interface 2878B comprising an ornamental design, such as a snowflake, on each flange 2876. Figure 41C shows an exemplary flange part 2870C including a textured interface 2878C on flanges 2876 comprising a plurality of circular protrusions and/or depressions arranged in an irregular pattern relative to each other.

[0310] By way of further example, with reference now to Figure 41D, a flange part 2870D may include a textured interface 2878D comprising a plurality of diamond-shaped protrusions and/or openings positioned in a grid-like arrangement along the flanges 2876. It should be understood that the various textured interfaces shown and described herein may be configured to improve the grip, control, aesthetics and/or ergonomics of the flange part. It should further be understood that the textured interfaces shown and described herein are merely illustrative, so that various other suitable patterns, textures and/or features may be included in the flange parts without departing from the scope of this disclosure.

[0311] The components of the devices described in this document may be designed and/or suitable for manufacture in one or more ways. In some embodiments, for example, the components of the devices described in this document (e.g., device 1050, device 1200, device 1300, device 1400, device 2400, device 2500, device 2600, device 2800, etc.) may be suitable for manufacture via, for example, injection molding, three-dimensional printing, or machining. In one embodiment, for example, the components of device 1050 may be particularly suitable for manufacture by injection molding. For example, in some existing devices, molding is not suitable for high-volume production, resulting in the use of three-dimensional printing. In some embodiments, although manufacturing tolerances may be tighter with molding techniques than with three-dimensional printing techniques, devices formed by three-dimensional printing do not have the same level of precision as devices formed by molding. Precision can be particularly important for devices of the present discovery, for example, those devices used for vitreous injections in volumes of 100 μl or less.

[0312] Therefore, it should be understood that the present disclosure devices described herein may be designed to store predefined volumes of therapeutic agent that may be suitable for vitreous injections (VIT), such as, for example, 100 μl or less. In some embodiments, the devices described herein may be designed for injection of certain vitreous volumes based on an intended use of the device in a specific procedure. For example, the present disclosure devices may be configured to store a vitreous volume of about 65 μl to about 75 μl for high-dose aflibercept procedures; about 95 μl to about 105 μl for MiniTrap procedures; and/or about 5 μl to about 15 μl for Retinopathy of Prematurity (ROP).

[0313] The devices of the present disclosure can be further configured to store relatively larger volumes of vitreous for injection based on a degree of myopia, such as approximately 3 milliliters, 4 milliliters, and more. Furthermore, the devices described herein can be designed for the injection of larger volumes of vitreous based on an intended procedure, such as approximately 3 ml to approximately 6 ml of silicone or gas for post-vitrectomy tamponade. It should be understood that the devices of the present disclosure can be designed to inject various other volumes of vitreous in relation to other procedures, such as Diabetic Eye Disease, post-injection non-infectious endophthalmitis, Neovascular (wet) Age-Related Macular Degeneration (AMD), Macular Edema after Retinal Vein Occlusion (RVO), Diabetic Macular Edema (DME), and Diabetic Retinopathy (DR).

[0314] The devices of the present disclosure are operable to provide accurate measurements in the delivery of large volumes of vitreous with high precision, minimizing instances of user error in incorrect adjustment of a dosing line. As described in detail above, the various designs and configurations of one or more components of the devices described herein (e.g., a plunger rod, a flange part, etc.) can provide dosing accuracy by controlling a priming distance and a dosing delivery distance of the device, thus removing the user's determination in setting the device in each respective configuration.

[0315] The features listed above have been described within the context of particular modalities. However, as an individual of average skill in the technique would understand, the features and aspects of each modality can be combined, added to other modalities, subtracted from a modality, etc., in any manner suitable to assist in controlled priming and/or drug delivery.

[0316] Aspects of the embodiments disclosed herein are described in relation to priming drug delivery devices and removing excess air bubbles from the interior of drug delivery devices, and some embodiments disclosed herein are described as being particular types of drug delivery devices (e.g., pre-filled syringes). Aspects of the present disclosure may also be employed and/or found in other types of drug delivery devices (e.g., refillable syringes, pipettes, and the like). For example, devices with features according to the present disclosure may provide more precise means of transferring a volume of a pharmaceutical substance or other fluid from one container to another, such as from a vial to a syringe. The precision in fluid transfer provided by the embodiments disclosed herein may reduce or minimize unwanted overfilling and/or decrease waste of a pharmaceutical substance.

[0317] Although a number of embodiments are presented in this document, multiple variations of these embodiments and combinations of elements from one or more embodiments are possible and are contemplated as being encompassed within the scope of this disclosure. Furthermore, those skilled in the art will understand that the concept upon which this disclosure is based can be readily used as a basis for designing other devices, methods, and systems to accomplish the various purposes of this disclosure.

Claims (35)

1. Drug delivery device characterized in that it comprises: a body; a flange coupled to the body, the flange including a channel defined by an inner surface and a groove formed on the inner surface; and a plunger rod coupled to the flange, the plunger rod including a proximal end and an extension extending distally from the proximal end; wherein the extension is configured to compress radially inward and engage the inner surface as the plunger rod moves relative to the flange over a first stroke, the groove is configured to receive the extension and the extension is configured to expand radially outward as the plunger rod rotates relative to the flange, and the extension is configured to engage the groove of the flange as the plunger rod moves relative to the flange over a second stroke. 2. Drug delivery device according to claim 1, characterized in that the plunger rod is positioned relative to the flange such that the extension is radially misaligned with the groove when the plunger rod is coupled to the flange in a first position. 3. Drug delivery device according to claim 2, characterized in that the plunger rod is positioned relative to the flange so that the extension is radially aligned with the groove when the plunger rod is coupled to the flange in a second position. 4. Drug delivery device according to claim 3, characterized in that the plunger rod is configured to move from the first position to the second position. 5. Drug delivery device according to claim 4, characterized in that the extension is radially compressed inwards to a compressed state when in the first position. 6. Drug delivery device according to claim 4, characterized in that the flange includes an opening formed along the inner surface of the flange; and wherein the opening is configured to receive the extension when the plunger rod is coupled to the flange before moving to the first position. 7. Drug delivery device according to claim 6 characterized in that the flange is configured to inhibit the proximal and rotational movement of the plunger rod relative to the channel when the extension is received at the opening; wherein the extension is configured to exit the opening when the plunger rod moves distally relative to the flange towards the first position. 8. Drug delivery device according to claim 4, characterized in that the flange includes a recess formed along a lower wall of the flange; and in that the recess is configured to receive the extension when the plunger rod moves distally relative to the flange from the second position to a third position. 9. Drug delivery device according to claim 8, characterized in that the extension is positioned proximal to the indentation when the plunger rod is in either the first or second position. 10. Drug delivery device according to claim 8, characterized in that the recess defines a depression along the lower wall of the flange, wherein the depression is sized so that the extension does not come into contact with the lower wall when the plunger rod moves to the third position. 11. Drug delivery device according to claim 8, characterized in that the flange is configured to at least partially compress the extension radially inward toward the retraction when the plunger rod moves to the third position. 12. Drug delivery device according to claim 2, characterized in that the flange is configured to inhibit the proximal movement of the plunger rod relative to the channel when the groove receives the extension; wherein the proximal end of the plunger rod is fixed within the flange when the extension is disposed within the groove. 13. Drug delivery device according to claim 2, characterized in that the drug delivery device is configured to generate user feedback in response to the groove receiving the extension. 14. Drug delivery device according to claim 1, characterized in that the device contains a drug configured to treat an eye disease. 15. Drug delivery device according to claim 14, characterized in that the drug includes an anti-VEGF agent and the eye disease includes an angiogenic eye disease. 16. Drug delivery device according to claim 15, characterized in that the anti-VEGF agent is aflibercept. 17. Drug delivery device according to claim 16, characterized in that, in response to the locking component that controls the movement of a stop relative to the body, the drug delivery device is configured to administer a volume of less than 75 μl of aflibercept to a patient's eye. 18. Drug delivery device according to claim 17, characterized in that the aflibercept injection has a concentration of at least 8 mg. 19. Drug delivery device characterized in that it comprises: a body storing a dose of medication; a flange coupled to the body, the flange including a side wall, a channel defined by the side wall, and a pair of grooves formed along an interior of the side wall; and a plunger rod coupled to the flange and at least partially disposed within the body, the plunger rod including a proximal end and a pair of extensions extending distally from the proximal end; wherein the plunger rod is configured to prime the drug delivery device by moving a first stroke relative to the flange, thereby positioning the pair of extensions against the side wall; and wherein the plunger rod is configured to prepare the drug delivery device to deliver the dose of medication by rotating relative to the flange, thereby generating user feedback as the pair of extensions expands radially outward from a compressed state to an extended state upon engaging the pair of grooves. 20. Drug delivery device according to claim 19, characterized in that the plunger rod is positioned relative to the flange such that the pair of extensions is radially misaligned with the pair of grooves when the plunger rod moves the first stroke, and the pair of extensions is radially aligned with the pair of grooves when the plunger rod is rotated relative to the flange. 21. Drug delivery device according to claim 19, characterized in that the plunger rod includes a protrusion extending radially outward from an outer part of the proximal end, and the flange includes a slot formed along the lateral wall; and wherein, when the protrusion is misaligned with the slot, the flange restricts the distal movement of the plunger rod through the channel to a first position, and when the protrusion is aligned with the slot, the flange restricts the distal movement of the plunger rod through the channel to a second position when the protrusion abuts the slot, the second position being positioned distally to the first position. 22. Drug delivery device according to claim 19, characterized in that the flange includes a cavity, a pair of ribs extending into the cavity and a pair of movable tabs extending into the channel; and wherein the pair of ribs is configured to engage an upper flange of the body and the pair of movable tabs is configured to engage a rod of the body, thus coupling the flange to the body. 23. Drug delivery device according to claim 19, characterized in that the body includes a drug configured to treat an eye disease. 24. Drug delivery device according to claim 23, characterized in that the drug includes an anti-VEGF agent and the eye disease includes an angiogenic eye disease. 25. Drug delivery device according to claim 24, characterized in that the anti-VEGF agent is aflibercept. 26. Drug delivery device according to claim 25, characterized in that, in response to the locking component that controls the movement of a stop relative to the body, the drug delivery device is configured to administer a volume of less than 75 μl of aflibercept to a patient's eye. 27. Drug delivery device according to claim 26, characterized in that the aflibercept injection has a concentration of at least 8 mg. 28. Drug delivery device characterized in that it comprises: a body; a flange coupled to the body, the flange including a collar having a channel, and a pair of grooves positioned along opposite sides of the channel; and a plunger rod coupled to the flange with the channel configured to accept the plunger rod, the plunger rod including a proximal portion and a pair of extensions extending distally from opposite sides of the proximal portion; wherein the plunger rod is longitudinally movable and rotatable relative to the flange, wherein the plunger rod is configured to: move distally relative to the flange by an initial stroke to prime the drug delivery device, wherein the pair of extensions is radially misaligned and positioned outside the pair of grooves when the plunger rod moves in the initial stroke; to rotate relative to the flange to prepare the drug delivery device to deliver a dose of medication to the body, wherein the pair of extensions align radially and come into contact with the pair of grooves, thus generating audible feedback as the plunger rod rotates relative to the flange; and to move distally relative to the flange by a final stroke to deliver the dose of medication from the drug delivery device, wherein the pair of extensions is held within and in contact with the pair of grooves as the plunger rod moves in the final stroke. 29. Drug delivery device according to claim 28, characterized in that the plunger rod includes a pair of protrusions extending radially outward from the proximal portion, and the flange includes a pair of slots formed at a proximal end of the collar; and wherein the flange restricts the distal movement of the plunger rod through the channel to a first position when the pair of protrusions is misaligned with the pair of slots, and restricts the distal movement of the plunger rod through the channel to a second position that is distal to the first position when the pair of protrusions is aligned and is received in the pair of slots. 30. Drug delivery device according to claim 28, characterized in that the flange is configured to inhibit proximal movement of the plunger rod relative to the channel when the groove pair receives the extension pair. 31. Drug delivery device according to claim 28, characterized in that the body includes a drug configured to treat an eye disease. 32. Drug delivery device according to claim 31, characterized in that the drug includes an anti-VEGF agent and the eye disease includes an angiogenic eye disease. 33. Drug delivery device according to claim 32, characterized in that the anti-VEGF agent is aflibercept. 34. Drug delivery device according to claim 33, characterized in that, in response to the locking component that controls the movement of a stop relative to the body, the drug delivery device is configured to administer a volume of less than 75 μl of aflibercept to a patient's eye. 35. Drug delivery device according to claim 34, characterized in that the aflibercept injection has a concentration of at least 8 mg.