WO2025199106A1 - Autoinjector - Google Patents

Autoinjector

Info

Publication number
WO2025199106A1
WO2025199106A1 PCT/US2025/020376 US2025020376W WO2025199106A1 WO 2025199106 A1 WO2025199106 A1 WO 2025199106A1 US 2025020376 W US2025020376 W US 2025020376W WO 2025199106 A1 WO2025199106 A1 WO 2025199106A1
Authority
WO
WIPO (PCT)
Prior art keywords
housing
latch
trigger
ram
needle
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/US2025/020376
Other languages
French (fr)
Inventor
Kallie JOHNSON
Kevin Swanson
Ryan WANGSNES
Scott BEACHER
Michael TRAVANTY
Baylor FRANTZ
Todd LEADENS
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Halozyme Inc
Original Assignee
Halozyme Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Halozyme Inc filed Critical Halozyme Inc
Publication of WO2025199106A1 publication Critical patent/WO2025199106A1/en
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/20Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3202Devices for protection of the needle before use, e.g. caps
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321Means for protection against accidental injuries by used needles
    • A61M5/3243Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/20Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M2005/2006Having specific accessories
    • A61M2005/2013Having specific accessories triggering of discharging means by contact of injector with patient body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/20Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M2005/2073Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically preventing premature release, e.g. by making use of a safety lock
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M2005/3125Details specific display means, e.g. to indicate dose setting
    • A61M2005/3126Specific display means related to dosing
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321Means for protection against accidental injuries by used needles
    • A61M5/3243Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/3245Constructional features thereof, e.g. to improve manipulation or functioning
    • A61M2005/3247Means to impede repositioning of protection sleeve from needle covering to needle uncovering position
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321Means for protection against accidental injuries by used needles
    • A61M5/3243Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/326Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user
    • A61M2005/3267Biased sleeves where the needle is uncovered by insertion of the needle into a patient's body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/20Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M5/2033Spring-loaded one-shot injectors with or without automatic needle insertion
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/20Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M5/2046Media being expelled from injector by gas generation, e.g. explosive charge
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/20Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M5/2053Media being expelled from injector by pressurised fluid or vacuum
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3202Devices for protection of the needle before use, e.g. caps
    • A61M5/3204Needle cap remover, i.e. devices to dislodge protection cover from needle or needle hub, e.g. deshielding devices

Definitions

  • the present disclosure generally relates to autoinjectors and, in some embodiments, needle guard actuated autoinjectors for the delivery of large volumes of medicament for sub skin surface penetration.
  • an injector including a housing having a proximal end, a distal end, and a longitudinal axis extending between the proximal end and the distal end, a medicament container disposed within the housing and containing a volume of a medicament, a needle coupled to a distal end of the medicament container and in fluid communication therewith, a needle guard at least partially disposed within the distal end of the housing and moveable relative to the housing along the longitudinal axis from an extended position where the needle guard extends distally from the housing to cover the needle, to a retracted position where the needle guard is moved proximally to at least partially expose the needle, to a lockout position where the needle guard extends distally from the housing to cover the needle, a trigger disposed within the housing and coupled to the needle guard, a latch disposed within the housing, the latch configured to engage the trigger, a ram movable relative to the latch, and an energy source configured to urge the ram distally relative to the latch
  • the latch includes a latch body, a first latch member moveable between a first flexed position wherein the first latch member is flexed radially outward relative to the latch body and a first relaxed position wherein the first latch member is generally flush with the latch body, and a second latch member moveable between a second flexed position wherein the second latch member is flexed radially inward relative to the latch body and a second relaxed position wherein the second latch member is generally flush with the latch body.
  • the first latch member in the first flexed position prevents movement of the needle guard from the retracted position toward the lockout position. In some embodiments, movement of the ram distally past the first latch member allows the first latch member to move from the first flexed position to the first relaxed position thereby allowing the needle guard to move from the retracted position toward the lockout position. In some embodiments, the second latch member in the second relaxed position prevents movement of the needle guard into the lockout position.
  • movement of the ram distally past the second latch member allows the second latch member to move from the second relaxed position to the second flexed position thereby allowing the needle guard to move into the lockout position.
  • at least a portion of the trigger is engaged between the latch and the medicament container when the needle guard is in the lockout position, thereby preventing movement of the needle guard along the longitudinal axis.
  • the first latch member includes a first flexible arm extending along the longitudinal axis and a first protrusion extending radially inward therefrom.
  • ram includes a ram body.
  • a ram aperture extends through the ram body, the ram aperture receiving at least a portion of the first protrusion when the needle guard is in the extended position.
  • the ram aperture receiving the first protrusion prevents movement of the ram relative to the latch and relative to the housing.
  • movement of the needle guard from the extended position to the retracted position aligns a window of the trigger with the first latch member, thereby allowing the first latch member to move into the first flexed position and allowing movement of the ram relative to the latch.
  • the medicament container includes a plunger disposed therein, and wherein the ram engages the plunger thereby moving the plunger relative to the medicament container.
  • movement of the plunger relative to the medicament container ejects the volume of the medicament from the medicament container through a needle disposed at a distal end thereof.
  • the second latch member includes a second flexible arm extending along the longitudinal axis and a second protrusion extending radially outward therefrom.
  • the injector further includes a needle guard return configured to bias the needle guard distally relative to the housing.
  • the needle guard return is disposed between a proximal end of the trigger and a distal end of the latch.
  • a distal end of the needle guard extends a first distance from the housing in the extended position, wherein the distal end of the needle guard extends a second distance from the housing in the lockout position, and wherein the second distance is greater than the first distance.
  • the latch is fixed relative to the housing, and wherein the medicament container is fixed relative to the housing.
  • the volume of the medicament is at least 10 mL.
  • the trigger includes a trigger ring disposed thereon configured to prevent radial deformation of the trigger.
  • the trigger ring is disposed on an outer surface of the trigger. In some embodiments, the trigger ring is disposed on an inner surface of the trigger.
  • the injector further includes a window extending through the housing and a dose indicator disposed on the ram.
  • the dose indicator is viewable through the window during delivery of a dose of the medicament to a subject.
  • the ram and dose indicator are moveable relative to the window when the energy source urges the ram distally relative to the latch during delivery of the dose of the medicament to a subject.
  • the window includes a status indicator disposed thereon, where the dose indicator is positioned proximate the status indicator when delivery of the dose of the medicament is complete.
  • the dose indicator is aligned with the status indicator when delivery of the dose of the medicament is complete.
  • an injector including a housing having a proximal end, a distal end and a longitudinal axis extending between the proximal end and the distal end, a medicament container disposed within the housing and containing a volume of a medicament, a needle coupled to a distal end of the medicament container and in fluid communication therewith, a needle guard at least partially disposed within the distal end of the housing and moveable relative to the housing along the longitudinal axis from an extended position wherein the needle guard extends distally from the housing to cover the needle, to a retracted position wherein the needle guard is moved proximally to at least partially expose the needle, to a lockout position wherein the needle guard extends distally from the housing to cover the needle, a trigger disposed within the housing and coupled to the needle guard, a latch disposed within the housing, the latch configured to engage the trigger and including a latch body, a first latch member moveable between a first flexed position wherein the first latch
  • the trigger is engageable with the ram such that movement of the needle guard from the retracted position to the lockout position is dependent upon the position of the ram.
  • the needle guard return is disposed between a proximal end of the trigger and a distal end of the housing.
  • an injector including a housing having a proximal end, a distal end, and a longitudinal axis extending between the proximal end and the distal end, a housing collar defined on the housing proximate the distal end and a cap removably coupled to the distal end of the housing, the cap having a cap body and a cap collar.
  • the cap is threadedly coupled to the housing such that rotation of the cap about the longitudinal axis in a first direction urges the cap distally relative to the housing and rotation of the cap in a second direction urges the cap proximally relative to the housing.
  • the housing collar prevents distal movement of the cap collar relative to the housing collar.
  • the cap collar is separated from the cap body and retained on the housing when the cap is rotated in the first direction.
  • the injector further includes a medicament container disposed within the housing and containing a volume of a medicament, a needle coupled to a distal end of the medicament container and in fluid communication therewith, and a needle guard at least partially disposed within the distal end of the housing and moveable relative to the housing along the longitudinal axis.
  • the cap includes an engagement thread extending inward from the cap body, the engagement thread configured to engage the needle guard to prevent proximal movement of the needle guard when the cap is coupled to the housing.
  • the cap includes a needle shield receiver defined on a distal end thereof, the needle shield receiver configured to couple the cap to a needle shield removably coupled to the needle when the cap is coupled to the housing, and wherein removal of the cap from the housing removes the needle shield from the needle.
  • an injector including a housing having a proximal end, a distal end, and a longitudinal axis extending between the proximal end and the distal end, a medicament container disposed within the housing and containing a volume of a medicament, a needle coupled to a distal end of the medicament container and in fluid communication therewith, a needle guard at least partially disposed within the distal end of the housing and moveable relative to the housing along the longitudinal axis from an extended position where the needle guard extends distally from the housing to cover the needle, to a retracted position where the needle guard is moved proximally to at least partially expose the needle, to a lockout position where the needle guard extends distally from the housing to cover the needle, a trigger disposed within the housing and coupled to the needle guard, the trigger including a trigger ring configured to prevent radial deformation of the trigger, a latch disposed within the housing, the latch configured to engage the trigger, a ram movable relative to
  • the trigger is engageable with the ram such that movement of the needle guard from the retracted position to the lockout position is dependent upon the position of the ram relative to the latch.
  • FIG. 1 is a perspective view of an autoinjector in accordance with a first exemplary embodiment of the present disclosure
  • FIG. 2 is a perspective view of the autoinjector of Fig. 1 with the cap removed;
  • Fig. 3 is a side cross-sectional view of the autoinjector of Fig. 1 with the front housing separated from the rear housing;
  • Figs. 4A-4B is a side cross-sectional view of the autoinjector of Fig. 1 with the coupling of the front housing and the rear housing magnified;
  • FIG. 5 is a perspective view of the medicament container having a staked needle of the autoinjector of Fig. 1;
  • Fig. 6 is a perspective view of the needle guard of the autoinjector of Fig. 1 ;
  • Fig. 7 is a perspective view of the trigger of the autoinjector of Fig. 1;
  • Fig. 8 is a perspective view of the latch of the autoinjector of Fig. 1;
  • Fig. 9 is a perspective view of the ram of the autoinjector of Fig. 1;
  • Fig. 10A is a side cross-sectional view of the rear housing of the autoinjector of Fig. 1 shown in the initial state;
  • Fig. 10B is a side cross-sectional view of the front housing of the autoinjector of Fig. 1 shown in the initial state;
  • Fig. 11A is a side cross-sectional view of the rear housing of the autoinjector of Fig. 1 shown in the pre-firing state;
  • Fig. 1 IB is a side cross-sectional view of the front housing of the autoinjector of Fig. 1 shown in the pre-firing state;
  • Fig. 12A is a side cross-sectional view of the rear housing of the autoinjector of Fig. 1 shown in the triggering state;
  • Fig. 12B is a side cross-sectional view of the front housing of the autoinjector of Fig. 1 shown in the triggering state;
  • Fig. 13A is a side cross-sectional view of the rear housing of the autoinjector of Fig. 1 shown during a delivery;
  • Fig. 13B is a side cross-sectional view of the front housing of the autoinjector of Fig. 1 shown during a delivery;
  • Fig. 14A is a side cross-sectional view of the rear housing of the autoinjector of Fig. 1 shown during a delivery;
  • Fig. 14B is a side cross-sectional view of the front housing of the autoinjector of Fig. 1 shown during a delivery;
  • Fig. 15A is a side cross-sectional view of the rear housing of the autoinjector of Fig. 1 shown in the lockout state;
  • Fig. 15B is a side cross-sectional view of the front housing of the autoinjector of Fig. 1 shown in the lockout state;
  • Fig. 16 is a side view of the cap shown partially transparent for illustration purposes coupled to the housing of the autoinjector of Fig. 1 and shown in the initial state;
  • Fig. 17 is a side cross-sectional view of the cap coupled to the housing of the autoinjector of Fig. 1 and shown in the initial state;
  • Fig. 18 is a side view of the second exemplary embodiment of the front housing of an autoinjector in accordance with the present disclosure
  • Fig. 19 is a perspective view of the second exemplary embodiment of the trigger of an autoinjector in accordance with the present disclosure
  • Fig. 20A is a perspective view of the third exemplary embodiment of the trigger of the autoinjector in accordance with the present disclosure
  • Fig. 20B is a perspective view of the trigger of Fig. 20A with a transparent trigger body to illustrate the trigger band disposed therein;
  • Fig. 20C is a cross-sectional perspective view of the trigger of Fig. 20A;
  • Fig. 21 is a side view of a portion of the second embodiment of the rear housing of an autoinjector in accordance with the present disclosure
  • Fig. 22 is a side view of a portion of the third embodiment of the rear housing of an autoinjector in accordance with the present disclosure
  • FIG. 23 is a side view of a portion of the fourth embodiment of the rear housing of an autoinjector in accordance with the present disclosure.
  • Fig. 24 is a side view of a portion of the fifth embodiment of the rear housing of an autoinjector in accordance with the present disclosure
  • Fig. 25 is a side view of a portion of the sixth embodiment of the rear housing of an autoinjector in accordance with the present disclosure
  • Fig. 26 is a side view of a portion of the seventh embodiment of the rear housing of an autoinjector in accordance with the present disclosure
  • FIG. 27 is a side view of a portion of the eighth embodiment of the rear housing of an autoinjector in accordance with the present disclosure.
  • Fig. 28 is a side view of a portion of the ninth embodiment of the rear housing of an autoinjector in accordance with the present disclosure.
  • Fig. 29 is a side view of a portion of the tenth embodiment of the rear housing of an autoinjector in accordance with the present disclosure.
  • the present disclosure generally relates to autoinjectors, needle guard and/or button actuated triggering devices that are used in the delivery of large volumes (e g., 10 ml or larger doses) of injectable fluid, such as medicament, for sub skin surface penetration (e.g., subcutaneous and intramuscular injections).
  • injectable fluid such as medicament
  • sub skin surface penetration e.g., subcutaneous and intramuscular injections.
  • Devices that deliver large volumes of medicament are often prone to configuration restrictions as the delivery volume of the medicament increases, such as spring force limitations and syringe container breakage. Due to the current configurations of overall device design, and the limitations of the biological uptake factors that limit injection speed and volume, injection devices are often held by the user during injection for long durations and can result in other delivery methods being used such as on-body delivery systems which are attached to the patient during delivery.
  • biologies are allowing for at-home administration by patients.
  • large doses and the resulting large volume of medicament that must be delivered often precludes self-administration because of the length of time required to hold the delivery device in place during injection.
  • Protein hyper-concentration may be used to reduce injection volume in certain instances, but the resulting medicament often has a much higher viscosity than the traditional biologies.
  • High-powered injectors may allow delivery of these hyper-concentrated proteins.
  • typical handheld injector designs only allow for up to 2.5 mb of a viscous medicament to be injected within 30 seconds.
  • a staked needle refers to a needle permanently attached or affixed to a medicament container or syringe during manufacturing, forming a single, integral unit, that is, a needle pre-attached to the medicament container that is not intended to be removed. Additionally, the one-piece construction of staked needles can enhance sterility by minimizing potential points of contamination, making them advantageous for self-administration.
  • rHuPH20 works by degrading the HA, which plays a role in resistance to bulk fluid flow in the SC space, limiting large volume SC drug delivery, dispersion, and absorption.
  • Co-administration of rHuPH20 with injectable therapies can overcome administration time and volume barriers associated with existing SC therapeutic formulations, and has been shown to reduce the burden on patients and healthcare providers compared with intravenous formulations.
  • rHuPH20 has countless applications in the current field of injectable therapies by increasing the dispersion and absorption of other injected drugs, such as anticancer therapies (e.g., trastuzumab and rituximab), immunodeficiency treatment, in subcutaneous urography for improving resorption of radiopaque agents, and fluid delivery for rehydration.
  • anticancer therapies e.g., trastuzumab and rituximab
  • immunodeficiency treatment in subcutaneous urography for improving resorption of radiopaque agents, and fluid delivery for rehydration.
  • FIG. 1 an autoinjector, generally designated 10, in accordance with an exemplary embodiment of the present invention.
  • the injector 10 may include a housing 100, a medicament container 102, a needle 104, a needle guard 106, a trigger 108, a latch 110, a ram 112 and an energy source 114.
  • the injector 10 includes a cap 120 removably coupled to the housing 100.
  • the cap 120 may cover the needle 104 to provide sharps protection and may couple to the needle guard 106 to prevent premature or accidental triggering of the injector 10.
  • the housing 100 may have a proximal end and a distal end extending along a longitudinal axis AL.
  • the housing 100 may be configured for allowing a user to grip or handle the injector 10.
  • the housing 100 may be shaped to fit into a user’s hand for single-handed function.
  • the housing 100 may have a generally circular cross section. In some embodiments, the housing 100 has an oval cross-section to help position the injector 10 in the user’s hand.
  • the housing 100 may substantially house the components shown in Figs. 3-17. [0067] Referring to Figs. 1-4, the housing 100 may comprise a front housing 116 and a rear housing 118.
  • the front housing 1 16 and rear housing 118 may be coupled together by snap-fit coupling.
  • the front housing 116 and rear housing 118 are coupled using an adhesive or other suitable means to prevent separation during use of the injector 10.
  • the front housing 116 and rear housing 118 are integrally formed together during manufacturing or assembly of the injector 10.
  • the housing 100 may be formed from a plastic with sufficient rigidity to prevent outside forces from interfering with the interactions of the internal components of the injector 10.
  • the front housing 116 and the rear housing 118 may be fixed relative to each other.
  • the front housing 116 may include a front engagement component 124 defined thereon.
  • the front engagement component 124 may extend radially outward from the front housing 116.
  • the front engagement component 124 may extend radially inward from the front housing 116.
  • the rear housing 118 may include a rear engagement component 126 defined thereon.
  • the rear engagement component 126 may be an aperture extending through the rear housing 118.
  • the rear engagement component 126 may be shaped and sized to receive the front engagement component 124 when the front housing 116 and the rear housing 118 are coupled together.
  • Engagement of the front engagement component 124 and the rear engagement component 126 may prevent the front housing 116 from moving relative to the rear housing 118.
  • the rear engagement component 126 extends radially inward or radially outward from the rear housing 118.
  • the front engagement component 124 is an aperture extending through the front housing 116.
  • the front housing 116 may include a window 122 defined therein.
  • the window 122 may be a generally ovular aperture extending through the front housing 116.
  • the window 122 is circular or rectangular.
  • the window 122 may include a transparent film extending across the aperture defining the window 122.
  • the film may be a transparent plastic or glass.
  • the window 122 does not include a film.
  • the front housing 116 may be configured to house the medicament container 102, the needle 104 and the needle guard 106.
  • the medicament container 102 may be at least partially disposed within the housing 100.
  • the medicament container 102 may be fixed relative to the housing 100.
  • the medicament container 102 may contain a volume of a medicament.
  • the medicament may comprise drugs, biologies, solutions, gels, suspensions or other substances that may be delivered via a syringe or needle, and such terms may be used interchangeably as appearing in the specification and claims.
  • the medicament container 102 may be a prefilled syringe.
  • the medicament container 102 may be an insertable medicament cartridge.
  • the medicament container 102 may be filled using a vial-and-needle or other appropriate filling method.
  • the medicament container 102 is one of a prefilled cartridge, prefilled staked needle syringe, vial, or other injectable fluid containing vessel.
  • the medicament container 102 has a distal portion and a proximal portion opposite the distal portion.
  • the medicament container 102 may comprise a container portion 128 defining a fluid chamber containing the medicament.
  • the container portion 128 may be open on a first end and may be tapered on a second end.
  • the first end may include a container lip 134 extending radially therefrom.
  • the container lip 134 may be configured to engage the housing 100 to prevent distal movement of the medicament container 102 relative to the housing 100.
  • the second end may include the needle 104, as described in more detail below.
  • the container portion 128 of the medicament container 102 has a maximum volume of approximately 10 mL.
  • the container portion 128 of the medicament container 102 has a maximum volume selected from approximately: a) 3 mL, 3.5 mL, 4 mL, 4.5 mL, 5.5 mL, 6 mL, 6.5 mL, 7 mL, 7.5 mL, 8 mL, 8.5 mL,
  • the medicament container 102 may further comprise a plunger 130 movable within the container portion 128 relative to the medicament container 102.
  • the plunger 130 Prior to use or triggering of the injector 10, the plunger 130 may be disposed within the container portion 128 proximate the distal portion of the medicament container 102.
  • the plunger 130 may seal the medicament in the container portion 128.
  • the plunger 130 may be generally cylindrical and made of a rubber material.
  • the plunger 130 is made of aplastic, butyl rubber, polyisoprene, polytetrafluorethylene, high density polyethylene or other thermoset elastomers.
  • the needle 104 is in fluid communication with the medicament in the container portion 128.
  • the needle 104 may be integrally formed in the distal portion of the medicament container 102.
  • the medicament container 102 includes a needle support 132 extending from the distal portion thereof.
  • the needle support 132 may be a generally cylindrical member configured to couple the needle 104 to the medicament container
  • the needle 104 prevent movement of the needle 104 relative to the medicament container 102.
  • the needle 104 may be a 25 gauge needle.
  • the needle 104 may correspond to a size selected from: a) 15 gauge, 16 gauge, 17 gauge, 18 gauge, 19 gauge, 20 gauge, 21 gauge, 22 gauge,
  • the injector 10 may be configured to deliver the entire amount or a portion of the medicament within medicament container 102.
  • the medicament contained in the medicament container 102 may have a volume of approximately 10 mb.
  • the medicament contained in the medicament container 102 corresponds to a volume selected from: a) 3 mL to 5 mL, 3 mL to 10 mL, 3 mL to 15 mL, 3 mL to 20 mL, 3 mL to 25 mL, 3 ml to 30 mL, 3 mL to 35 mL, 3 mL to 40 mL, 3 mL to 45 mL, 3 mL to 50 mL, 5 mL to 10 mL,
  • Flow rate of the injector 10 is heavily dependent on the viscosity and volume of the medicament.
  • the injector 10 may deliver the full volume of the medicament at a rate of approximately 0.33 mL/sec.
  • the injector 10 may deliver 10 mL of the medicament at a rate of 0.33 mL/sec.
  • the injector 10 delivers the full deliverable volume of the medicament at a rate of: a) 0.5 mL/10 sec., 0.75 mL/10 sec., 1 mL/10 sec., 1.25 mL/10 sec., 1.5 mL/10 sec., 1.75 mL/10 sec, 2 mL/10 sec., 2.25 mL/10 sec, 2.5 mL/10 sec., 2.75 mL/10 sec, 3 mL/10 sec., 3.25 mL/10 sec, 3.5 mL/10 sec., 3.75 mL/10 sec, 4 mL/10 sec., 4.25 mL/10 sec, 4.5 mL/10 sec., 4.75 mL/10 sec, 5 mL/10 sec; b) at least 0.5 mL/10 sec., at least 0.75 mL/10 sec., at least 1 mL/10 sec., at least 1.25 mL/10 sec., at least 1.5 mL/10 sec., at least 1.75 mL/10 sec, at least 2 mL/10
  • the viscosity of the medicament may be between 1-20 cP.
  • the medicament may have a viscosity of: a) 1 cP, 2 cP, 3 cP, 4 cP, 5 cP, 6 cP, 7 cP, 8 cP, 9 cP, 10 cP, 11 cP, 12 cP, 13 cP, 14 cP,
  • the user’s experience is improved if the injector 10 delivers the full volume of the medicament as fast as possible. A faster delivery may result in less pain and discomfort for the patient.
  • the injector 10 may deliver the full deliverable volume of the medicament in less than
  • the injector 10 may deliver the full deliverable volume of the medicament in less than 10 seconds, less than 15 seconds, less than 20 seconds, less than 25 seconds, less than 30 seconds, less than 35 seconds, less than 40 seconds, less than 45 seconds, less than 50 seconds, less than 55 seconds, less than 60 seconds, less than 70 seconds, less than 80 seconds, less than 90 seconds, less than 100 seconds, less than 110 seconds, or less than 120 seconds.
  • the injector 10 may deliver the full volume of the medicament in between 5-120 seconds, between 10-110 seconds, between 15-100 seconds, between 20-90 seconds, between 25-80 seconds, between 30-70 seconds, between 35-60 seconds, between 40-55 seconds, or between 45-50 seconds.
  • Needle guards (e.g., needle guard 106) play a crucial role in ensuring safety by minimizing the risk of accidental needlestick injuries and the potential transmission of bloodborne infections, thus promoting a safer experience.
  • the needle guard 106 may be at least partially disposed within the distal end of the housing 100.
  • the needle guard 106 may be a generally cylindrical member with a guard aperture 136 extending through a distal end and at least one guard arm 138 extending from a proximal end.
  • the guard aperture 136 may be a generally circular aperture shaped and sized to allow the needle 104 to pass therethrough during use of the injector 10.
  • the distal end of the needle guard 106 may be generally rounded or tapered around the guard aperture 136.
  • the needle guard 106 may include a cap engagement feature 140 extending radially therefrom.
  • the cap engagement feature 140 may be a generally rounded member located proximate the distal end of the needle guard 106.
  • the needle guard 106 includes two or more cap engagement features 140 spaced apart from each other proximate the distal end of the needle guard 106.
  • the cap engagement feature 140 may interact with the cap 120 to removably couple the cap 120 to the needle guard 106.
  • the guard arm 138 may extend proximally from the needle guard 106.
  • the guard arm 138 may have a curvature substantially similar to that of the needle guard 106 so as to act as a proximal extension of the needle guard 106.
  • the needle guard 106 includes two guard arms 138 spaced apart from each other. The space between the two guard arms may define a notch 142.
  • the notch 142 may be shaped and sized to avoid interference with the window 122 of the housing 100 during use of the injector 10.
  • the notch 142 may have a rounded distal portion and an open proximal portion.
  • the guard arm 138 may include a guard guide 144 defined thereon.
  • the guard guide 144 may extend radially from the guard arm 138.
  • the guard guide 144 may extend relative to the longitudinal axis AL along a length of the guard arm 138.
  • the guard guide 144 may extend along at least a portion of the length of the guard arm 138.
  • the guard guide 144 extends along the entire length of the guard arm 138.
  • the guard guide 144 may be configured to engage a feature defined on an inner surface of the front housing 116 to prevent rotation of the needle guard 106 relative to the housing 100.
  • the guard arm 138 includes two guard guides 144 spaced apart from each other.
  • the needle guard 106 and the trigger 108 are configured to couple relative to each other.
  • the needle guard 106 may include a trigger engagement feature 146 defined thereon.
  • the trigger engagement feature 146 may extend radially from the guard arm 138 proximate the proximal end thereof.
  • the trigger engagement feature 146 may be a generally rectangular member and may be spaced apart from the guard guide 144 so as to allow a portion of the trigger 108 to be received therebetween. Engagement of the trigger 108 and the trigger engagement feature 146 may prevent movement of the needle guard 106 relative to the trigger 108.
  • the needle guard 106 may be moveable relative to the housing 100 along the longitudinal axis AL from an extended position (Fig. 1 IB) where the needle guard 106 extends distally from the housing 100 to cover the needle 104, to a retracted position (Fig. 12B) where the needle guard 106 is moved proximally relative to the housing 100 to at least partially expose the needle 104, to a lockout position (Fig. 15B) where the needle guard 106 extends distally from the housing 100 to cover the needle 104.
  • a distal end of the needle guard 106 may extend a first distance from the housing 100 in the extended position.
  • the distal end of the needle guard 106 may extend a second distance from the housing 100 in the lockout position. The second distance may be greater than the first distance.
  • the first distance may be at least 20 mm.
  • the distal end of the needle guard 106 may be at least 4.5 mm from a distal end of the needle 104 in the extended position.
  • the distal end of the needle guard 106 may be at least about 5 mm to about 25 mm from the distal end of the needle 104 in the extended position.
  • the distal end of the needle guard 106 is at least about 5 mm, at least about 6 mm, at least about 7 mm, at least about 8 mm, at least about 9 mm, at least about 10 mm, at least about 11 mm, at least about 12 mm, at least about 13 mm, at least about 14 mm, at least about 15 mm, at least about 16 mm, at least about 17 mm, at least about 18 mm, at least about 19 mm, at least about 20 mm, at least about 21 mm, at least about 22 mm, at least about 23 mm, at least about 24 mm or at least about 25 mm from the distal end of the needle 104 in the extended position.
  • the distal end of the needle guard 106 is between about 5 mm and about 25 mm, between about 6 mm and about 24 mm, between about 7 mm and about 23 mm, between about 8 mm and about 22 mm, between about 9 mm and about 21 mm, between about 10 mm and about 20 mm, between about 11 mm and about 19 mm, between about 12 mm and about 18 mm, between about 13 mm and about 17 mm or between about 14 mm and about 16 mm from the distal end of the needle 104 in the extended position.
  • the second distance may be at least 25 mm.
  • the second distance may be at least 2 mm greater than the first distance. In some embodiments, the second distance is less than 2 mm greater than the first distance.
  • the distal end of the needle guard 106 may be at least 6.5 mm from the distal end of the needle 104 in the lockout position.
  • the distal end of the needle guard 106 may be at least about 7 mm to about 27 mm from the distal end of the needle 104 in the lockout position.
  • the distal end of the needle guard 106 is at least about 7 mm, at least about 8 mm, at least about 9 mm, at least about 10 mm, at least about 11 mm, at least about 12 mm, at least about 13 mm, at least about 14 mm, at least about 15 mm, at least about 16 mm, at least about 17 mm, at least about 18 mm, at least about 19 mm, at least about 20 mm, at least about 21 mm, at least about 22 mm, at least about 23 mm, at least about 24 mm, at least about 25 mm, at least about 26 mm or at least about 27 mm from the distal end of the needle 104 in the lockout position.
  • the distal end of the needle guard 106 is between about 7 mm and about 27 mm, between about 8 mm and about 26 mm, between about 9 mm and about 25 mm, between about 10 mm and about 24 mm, between about 11 mm and about 23 mm, between about 12 mm and about 22 mm, between about 13 mm and about 21 mm, between about 14 mm and about 20 mm, between about 15 mm and about 19 mm or between about 16 mm and about 18 mm from the distal end of the needle 104 in the extended position.
  • the inclusion of the cap 120 coupled to the housing 100 may assist with preventing premature movement of the needle guard 106.
  • the cap 120 may ensure the controlled and safe deployment of the needle 104 during use of the injector 10, thereby minimizing the risk of accidental injuries.
  • the cap 120 may include a cap body 148 and a cap collar 150.
  • the cap body 148 may be a generally cylindrical member with an open proximal end and a closed distal end.
  • the cap body 148 may have a plurality of ribs 152 defined on an exterior surface thereof.
  • the ribs 152 may extend around at least a portion of the circumference of the cap body 148. In some embodiments, the ribs 152 extend around the entire circumference of the cap body 148.
  • the ribs 152 may extend relative to the longitudinal axis AL along a length of the cap body 148.
  • the ribs 152 may extend along at least a portion of the length of the cap body 148. In some embodiments, the ribs 152 extend along the entire length of the cap body 148.
  • the cap collar 150 may provide a visual indicator of whether the cap 120 has been previously removed from the housing 100. This feature may enhance patient safety by providing a clear and easily discernible means to track the integrity of the injector 10.
  • the cap collar 150 may be configured to separate from the cap body 148 when the cap 120 is decoupled from the housing 100.
  • the cap collar 1 0 may include one or more cap collar coupling components 158 extending axially therefrom.
  • the cap collar coupling components 158 may removably couple the cap collar 150 to the cap body 148.
  • the cap collar coupling component 158 is a generally triangular feature.
  • a base of the cap collar coupling component 158 may be integrally formed on the cap collar 150.
  • a point of the cap collar coupling component 158 may engage the cap body 148.
  • the cap collar coupling components 158 may be configured to resist separation from the cap body 148 up to a threshold force.
  • the threshold force may be between about 5 inch-lbs to 12 inch-lbs of torque. In some embodiments, the threshold force is at least about 5 inch-lbs, at least about 6 inch-lbs, at least about 7 inch-lbs, at least about 8 inch-lbs, at least about 9 inch-lbs, at least about 10 inch-lbs, at least about 11 inch-lbs or at least about 12 inch-lbs. In some embodiments, the threshold force is between about 5 inch-lbs and 12 inch-lbs, between about 6 inch-lbs and 11 inch-lbs, between about 7 inch-lbs and 10 inch-lbs or between about 8 inch-lbs and 9 inch-lbs.
  • the housing 100 may include a housing collar 154 defined thereon configured to receive at least a portion of the cap collar 150 therein.
  • the housing collar 154 may prevent distal movement of the cap collar 150 relative to the housing collar 154 when the cap body 148 is removed from the housing 100.
  • the housing collar 154 may be located proximate the distal end of the housing 100.
  • the cap collar 150 may include one or more collar projections 156 (not shown) extending radially inward from the cap collar 150.
  • the collar projection 156 may be shaped and sized to be disposed in the housing collar 154. When the cap collar 150 is separated from the cap body 148, the cap collar 150 may be freely rotatable relative to the housing collar 154.
  • the cap 120 may be removably coupled to the distal end of the housing 100. Referring to Figs. 16 and 17, the cap 120 may be threadedly coupled to the housing 100 such that rotation of the cap 120 about the longitudinal axis AL in a first direction urges the cap 120 distally relative to the housing 100 and rotation of the cap 120 in a second direction urges the cap 120 proximally relative to the housing 100.
  • the cap 120 may include a cap thread 160 defined on an interior surface of the cap body 148.
  • the cap thread 160 may be configured to engage a housing thread 162 defined on the front housing 116.
  • the cap thread 160 may include two thread rails 164 spaced apart and configured to receive the housing thread 162 therebetween.
  • the thread rail 164 may extend radially in from the interior surface of the cap body 148.
  • the cap thread 160 is defined in the cap body and extends radially out from the interior surface of the cap body 148.
  • the housing thread 162 includes thread rails 164 configured to receive the cap thread 160.
  • the cap thread 160 and the housing thread 162 may be angled such that rotation in the first direction and second direction urge the cap distally or proximally relative to the housing 100, respectively.
  • the cap collar 150 may separate from the cap body 148 and may be retained on the housing 100 when the cap 120 is rotated in the first direction.
  • the cap 120 may physically restrain the needle guard 106 from moving proximally. This can be an important feature for preventing inadvertent needle movement in certain cases, such as dropping or other abrupt stops, adding an extra layer of safety to minimize the potential for accidental firing during handling or transportation.
  • the cap 120 may include a cap engagement thread 166 extending radially inward from the interior surface of the cap body 148.
  • the cap engagement thread 166 may engage the cap engagement feature 140 of the needle guard 106 to prevent proximal movement of the needle guard 106 when the cap 120 is coupled to the housing 100.
  • the cap engagement thread 166 may be angled such that rotation of the cap 120 in the second direction urges the cap engagement feature 140 of the needle guard 106 distally.
  • the cap 120 may couple to a needle shield 168 removably coupled to the needle 104 when the cap 120 is coupled to the housing 100. Further, simultaneous removal of the needle shield 168 when the cap 120 is separated from the housing 100 is an important safety measure, ensuring a seamless and controlled process that minimizes the risk of contamination and/or accidental needle exposure.
  • the cap 120 may include a cap aperture 172 defined on the distal end thereof.
  • a needle shield receiver 170 may extend through cap aperture 172.
  • the needle shield receiver 170 is the cap aperture 172.
  • a needle shield remover 173 may be disposed within the cap 120 and may be removably coupled to the needle shield 168 when the cap 120 is coupled to the housing 100.
  • the needle shield remover 173 is configured to flex to receive the needle shield 168 therein during assembly of the injector 10.
  • the needle shield remover 173 may be rotatable relative to the needle shield 168 when the cap 120 is separated from the housing 100.
  • the needle shield remover 173 is fixed to the needle shield 168.
  • the cap aperture 172 may be shaped and sized to receive at least a portion of a remover protrusion 174 of the needle shield remover 173 therethrough when the cap 120 is coupled to the housing 100.
  • the remover protrusion 174 may have a bulb or radial protrusion defined on a distal end thereof to prevent axial movement of the needle shield remover 173 relative to the cap 120 when the remover protrusion 174 is received in the cap aperture 172.
  • the needle shield remover 173 may be coupled to the cap 120 such that rotation of the cap 120 in the first direction and subsequent removal of the cap 120 from the housing 100 removes the needle shield 168 from the needle 104 thereby exposing the needle 104 within the needle guard 106.
  • the needle shield remover 173 may prevent axially movement of the needle shield 168 relative thereto when the cap 120 is removed from the housing 100.
  • the guard aperture 136 of the needle guard 106 may be sized and shaped to allow the needle shield 168 and needle shield remover 173 to pass therethrough during removal of the cap 120.
  • the trigger 108 may be disposed within the housing 100 and coupled to the needle guard 106.
  • the trigger 108 may be moveable relative to the housing 100 along the longitudinal axis AL in response to movement of the needle guard 106.
  • engagement of the trigger 108 with the latch 110 during movement of the trigger 108 may cause the injector 10 to expel the medicament.
  • the trigger 108 may be a generally cylindrical member extending along the longitudinal axis AL.
  • the trigger 108 may have a trigger body 176 and at least one trigger arm 178 extending axially from the trigger body 176.
  • the trigger body 176 may have a proximal end and a distal end opposite the proximal end. Both the proximal end and the distal end of the trigger body 176 may be open and sized to receive components of the rear housing 118 therein, as described in more detail below.
  • the trigger body 176 may include at least one trigger ring 180 extending around a circumference of the trigger body 176. In some embodiments, the trigger body 176 includes a plurality of trigger rings 180. The trigger ring 180 may be located proximate the proximal end of the trigger body 176.
  • the trigger ring 180 may provide improved rigidity of the trigger body 176 by increasing the cross-sectional thickness of the trigger body 176, thereby increasing the hoop strength of the trigger 108.
  • the trigger ring 180 may be integrally formed on the trigger body 176.
  • the trigger ring 180 is coupled to the trigger body 176 with an adhesive or welding.
  • the trigger body 176 may include a trigger aperture 182 extending therethrough.
  • the trigger aperture 182 may be shaped and sized to allow at least a portion of the latch 110 to extend therethrough.
  • the trigger aperture 182 may be located proximate the distal end of the trigger body 176. In some embodiments, the trigger aperture 182 is located between the proximal end and the distal end, or proximate the distal end of the trigger body 176.
  • the trigger aperture 182 may be a generally rectangular shape. In some embodiments, the trigger aperture 182 is a rounded shape.
  • the trigger body 176 may include a latch engagement feature 184 defined thereon. The latch engagement feature 184 may be located on an interior surface of the trigger body 176 proximate the distal end thereof.
  • the latch engagement feature 184 is shaped and sized to engage at least a portion of the latch 110 during use of the injector 10.
  • the trigger arm 178 may extend distally along the longitudinal axis AL from the trigger body 176.
  • the trigger arm 178 may be a generally rectangular member with a curvature about the longitudinal axis AL substantially similar to that of the trigger body 176.
  • the trigger arm 178 may include first arm member 188 and a second arm member 190 defining a trigger arm slot 186 therebetween.
  • the trigger arm slot 186 may extend from a distal end at least partially along a length of the trigger arm 178.
  • the trigger arm slot 186 may increase flexibility of the distal end of the trigger arm 178.
  • the first arm member 188 and second arm member 190 may be configured to flex toward each other in response to a radial force acting thereon. In some embodiments, only one of the first arm member 188 or the second arm member 190 is configured to move toward the other.
  • the first arm member 188 and second arm member 190 may each include a guard engagement surface 192 and a guard receiver 194 defined on the distal end thereof.
  • the guard engagement surface 192 may be angled such that engagement of the guard engagement surface 192 with the trigger engagement feature 146 of the needle guard 106 flexes the first arm member 188 and second arm member 190 toward each other as the front housing 116 and the rear housing 118 are moved toward each other.
  • the trigger engagement feature 146 may be received in the guard receiver 194 when the front housing 116 and the rear housing 118 are coupled together. Engagement of the guard receiver 194 and the trigger engagement feature 146 may couple the needle guard 106 and the trigger 108.
  • the first arm member 188 and second arm member 190 may flex apart when the trigger engagement feature 146 is received in the guard receiver 194.
  • the latch 110 may be disposed within the housing 100 and may be fixed relative thereto.
  • the latch 110 may be fixed proximate the proximal end of the housing 100 in the rear housing 118.
  • the latch 110 may be configured to engage the trigger 108 as the trigger 108 moves relative to the latch 110.
  • the latch 110 may include a latch body 196 having a generally cylindrical shape extending along the longitudinal axis AL.
  • the latch body 196 may be shaped and sized to fit within the trigger body 176.
  • the trigger body 176 may be disposed between the latch body 196 and the rear housing 118 and may be moveable relative to the latch body 196 and the rear housing 118.
  • the latch body 196 may include a trigger guide 204 defined thereon.
  • the trigger guide 204 may be an elongated recess defined along at least a portion of the latch body 196.
  • the trigger guide 204 may be configured to receive a portion of the trigger 108 to help align the movement of the trigger 108 along the longitudinal axis AL.
  • the latch 110 may include a latch collar 198 at a proximal end thereof.
  • the latch collar 198 may be a generally disc-shaped feature and may have a diameter larger than a diameter of the latch body 196.
  • the latch collar 198 may be integrally formed with the latch body 196.
  • the latch collar 198 is coupled to the latch body 196 with an adhesive or welding.
  • the latch collar 198 may include a housing engagement component 200 extending distally therefrom. At least a portion of the housing engagement component 200 may extend radially outward from the latch collar 198 and may be configured to engage the rear housing 118 to fix the latch 110 relative thereto.
  • the rear housing 118 may include a latch receiver 202 (Fig.
  • the latch 110 may include two housing engagement components 200 spaced apart on the latch collar 198. In some embodiments, the latch 110 includes at least two housing engagement components 200 spaced apart on the latch collar 198.
  • the latch 110 may include at least one collar support 206 coupled to the latch collar 198 and the latch body 196. The collar support 206 may reduce movement of the latch body 196 relative to the latch collar 198 during use of the injector 10.
  • the latch collar 198 may include a latch post 210 extending distally therefrom.
  • the latch post 210 may extend from a central portion of the latch collar 198 within the latch body 196.
  • the latch post 210 may have a length substantially similar to that of the latch body 196. In some embodiments, the latch post 210 is longer than the latch body 196. In some embodiments, the latch post 210 is longer than the latch body 196.
  • the latch post 210 may be spaced apart from the latch body 196 on all sides. Referring to Figs. 3-4, the latch post 210 may be disposed within the energy source 114 and the ram 112.
  • the latch post 210 may prevent radial movement of the energy source 114, thereby ensuring the force produced by the energy source 114 is exerted primarily onto the ram 1 12.
  • the latch post 210 may be a rounded member and may be tapered such that a diameter of the latch post 210 is greatest proximate to the latch collar 198 and smallest at a distal end of the latch post 210.
  • the latch 110 may include at least one container support 208 extending from a distal end of the latch body 196.
  • the container support 208 may be a generally rectangular member and may have a curvature substantially similar to that of the latch body 196 about the longitudinal axis AL.
  • the container support 208 may extend from the latch body 196 to engage the container lip 134 when the front housing 116 is coupled to the rear housing 118.
  • the container support 208 may prevent the medicament container 102 from moving proximally relative to the housing 100 during use of the injector 10.
  • the latch 110 may include two container supports 208 spaced apart on the distal end of the latch 110. In some embodiments, the latch includes more than two container supports 208 spaced apart on the distal end of the latch 110.
  • the latch 1 10 may prevent movement of the ram 1 12 relative to the housing 100 prior to an injection.
  • the latch 110 may include a latch aperture 214 extending through the latch body 196.
  • the latch aperture 214 may be a generally rectangular aperture and may include a first latch member 212 defined therein.
  • the first latch member 212 may extend proximally from a distal end of the latch aperture 214.
  • the first latch member 212 may have a width less than a width of the latch aperture 214.
  • the first latch member 212 may be spaced apart from both sides of the latch aperture 214.
  • the first latch member 212 may be moveable between a first flexed position wherein the first latch member 212 is flexed radially outward relative to the latch body 196 and a first relaxed position wherein the first latch member 212 is generally flush with the latch body 196.
  • the first latch member 212 may include a first flexible arm 216 extending proximally along the longitudinal axis AL and a first protrusion 218 extending radially inward from the first flexible arm 216.
  • the first flexible arm 216 may be a generally rectangular member.
  • the first protrusion 218 may be located at a proximate end of the first flexible arm 216 and may have a generally triangular cross section with angled surfaces facing proximally and distally. At least a portion of the first protrusion 218 is configured to be received by the ram 112 to prevent movement of the ram 112 relative to the latch 110, as described in more detail below.
  • the latch 110 may prevent the trigger 108 from moving distally during an injection.
  • the latch 110 may include a latch notch 220 extending through the latch body 196.
  • the latch notch 220 may be a generally rectangular notch having an open end facing away from the latch aperture 214.
  • the latch notch 220 is a rounded shape.
  • the latch notch 220 may include a second latch member 222 extending distally from a proximal end of the latch notch 220.
  • the second latch member 222 may have a width less than a width of the latch notch 220.
  • the second latch member 222 may be spaced apart from both sides of the latch notch 220.
  • the second latch member 222 may be moveable between a second flexed position wherein the second latch member 222 is flexed radially inward relative to the latch body 196 and a second relaxed position wherein the second latch member 222 is generally flush with the latch body 196.
  • the second latch member 222 may include a second flexible arm 224 extending distally along the longitudinal axis AL and a second protrusion 226 extending radially outward from the second flexible arm 224.
  • the second flexible arm 224 may be a generally rectangular member.
  • the second protrusion 226 may be located at a distal end of the second flexible arm 224 and may have a generally triangular cross section with angled surfaces facing proximally and distally. At least a portion of the second protrusion 226 is configured to be received by the trigger 108 to prevent movement of the trigger 108 relative to the housing 100, as described in more detail below.
  • the ram 112 is urged by the energy source 1 14 to move the plunger 130 through the medicament container 102 to expel the medicament through the needle 104.
  • the ram 112 may be movable relative to the latch 110 and the housing 100.
  • the ram 112 may include a ram body 228.
  • the ram body 228 may be a generally cylindrical member extending along the longitudinal axis AL.
  • the ram body 228 may have a proximal end and a distal end opposite the proximal end.
  • the proximal end of the ram body 228 may be open and the distal end of the ram body 228 may be closed.
  • the distal end of the ram body 228 may include a ram protrusion 230 extending therefrom.
  • the ram protrusion 230 may be a generally ovular member and may engage the plunger 130 during movement of the ram 112 relative to the medicament container 102.
  • the ram 112 may include a ram notch 232 extending through the ram body 228.
  • the ram notch 232 may be a generally rectangular notch having an open end facing proximally.
  • the ram notch 232 is a rounded shape.
  • the ram notch 232 may be shaped and sized to receive at least a portion of the first protrusion 218 of the latch 110 therein.
  • the ram body 228 may include a ram aperture 234 extending therethrough.
  • the ram aperture 234 may be a generally rectangular aperture. In some embodiments, the ram aperture 234 is rounded.
  • the ram aperture 234 may be shaped and sized to receive at least a portion of the first protrusion therein.
  • the ram aperture 234 receiving the first protrusion 218 may prevent movement of the ram 112 relative to the latch 110 and relative to the housing 100.
  • the energy source 114 may be configured to urge the ram 112 distally along the longitudinal axis AL relative to the latch 1 10.
  • energy source 1 14 may be disposed at least partially within the ram 112.
  • the energy source 114 may be disposed between the ram 112 and the latch post 210.
  • a proximal end of the energy source 114 may engage the latch collar 198 between the latch body 196 and the latch post 210.
  • a distal end of the energy source 114 may engage a distal end of the ram 112.
  • energy source 114 includes a compression spring; however, other suitable energy sources can be used, such as an electric pump, an elastomer or compressed-gas spring, or a gas generator, or other suitable energy storage members.
  • the energy source 114 may be a compression spring.
  • the energy source 114 may have a 5 mm diameter.
  • the energy source 114 may have a 6 mm diameter.
  • the energy source 114 may have a 7 mm diameter.
  • the energy source 114 may have an 8 mm diameter.
  • the energy source 114 may have a 9 mm diameter.
  • the energy source 114 may have a 10 mm diameter.
  • the energy source 114 may have an 11 mm diameter.
  • the energy source 114 may have a 12 mm diameter.
  • the energy source 114 may have a 13 mm diameter.
  • the energy source 114 may have a 14 mm diameter.
  • the energy source 114 may have a 15 mm diameter.
  • the energy source 114 may have a 0.75 mm wire diameter.
  • the energy source 114 may have a 1 mm wire diameter.
  • the energy source 1 14 may have a 1.25 mm wire diameter.
  • the energy source 114 may have a 1.5 mm wire diameter.
  • the energy source 114 may have a 1.75 mm wire diameter.
  • the energy source 114 may have a 2 mm wire diameter.
  • the energy source 114 may produce at least 8 lbs of force, at least 9 lbs of force, at least 10 lbs of force, at least 11 lbs of force, at least 12 lbs of force, at least 13 lbs of force, at least 14 lbs of force, at least 15 lbs of force, at least 16 lbs of force, at least 17 lbs of force, at least 18 lbs of force, at least 19 lbs of force, at least 20 lbs of force, at least 21 lbs of force, at least 22 lbs of force, at least 23 lbs of force, at least 24 lbs of force, at least 25 lbs of force, at least 26 lbs of force, at least 27 lbs of force, at least 28 lbs of force, at least 29 lbs of force, or at least 30 lbs of force.
  • the energy source 114 may produce between 8-30 lbs of force, between 9-29 lbs of force, between 10-28 lbs of force, between 11-27 lbs of force, between 12-26 lbs of force, between 13-25 lbs of force, between 14-24 lbs of force, between 15-23 lbs of force, between 16-22 lbs of force, between 17-21 lbs of force, or between 18-20 lbs of force.
  • the energy source 114 may generate up to 15 lbs of force prior to a triggering event.
  • the energy source 114 may generate up to 17.5 lbs of force prior to a triggering event.
  • the energy source 114 may generate up to 20 lbs of force prior to a triggering event.
  • the energy source 114 may generate up to 22.5 lbs of force prior to a triggering event.
  • the energy source 114 may generate up to 25 lbs of force prior to a triggering event.
  • the energy source 114 may generate up to 27.5 lbs of force prior to a triggering event.
  • the energy source 1 14 may generate up to 30 lbs of force prior to a triggering event.
  • the energy source 114 may generate a residual force of 8 lbs of force after expelling the full volume of fluid from the primary container.
  • the energy source 114 may generate a residual force of 10 lbs of force after expelling the full volume of fluid from the primary container.
  • the energy source 114 may generate a residual force of 12 lbs of force after expelling the full volume of fluid from the primary container.
  • the energy source 114 may generate a residual force of 14 lbs of force after expelling the full volume of fluid from the primary container.
  • the energy source 114 may generate a residual force of 16 lbs of force after expelling the full volume of fluid from the primary container.
  • the energy source 114 may generate a residual force of 18 lbs of force after expelling the full volume of fluid from the primary container.
  • the energy source 114 may generate a residual force of 20 lbs of force after expelling the full volume of fluid from the primary container.
  • the injector 10 may include a needle guard return 236 configured to bias the needle guard 106 distally relative to the housing 100.
  • the needle guard return 236 may be a compression spring, however, other suitable energy source can be used.
  • a proximal end of the needle guard return 236 may engage the latch collar 198 between the latch body 196 and the housing engagement component 200.
  • a distal end of the needle guard return 236 may engage the proximal end of the trigger 108 to urge the trigger 108 and needle guard 106 distally relative to the housing 100.
  • the injector 10 in an initial state, may include the cap 120 coupled to the housing 100.
  • the needle guard 106 is prevented from moving proximally along the longitudinal axis AL due to the cap engagement feature 140 interacting with the cap engagement thread 166.
  • the needle guard 106 is in a storage position when the cap 120 is coupled to the housing 100.
  • the needle guard 106 may extend a third distance from the housing in the storage position.
  • the needle guard 106 may extend approximately 17 mm from the housing 100 in the storage position.
  • the third distance may be less than the first distance and the second distance.
  • the first distance may be at least 3 mm greater than the third distance.
  • the third distance is the same as the first distance.
  • the third distance is the same as the first distance and the second distance.
  • the distal end of the needle guard 106 may be at least 4.5 mm from the distal end of the needle 104 in the storage position.
  • the distal end of the needle guard 106 may be at least about 3 mm to about 23 mm from the distal end of the needle 104 in the storage position.
  • the distal end of the needle guard 106 is at least about 3 mm, at least about 4 mm, at least about 5 mm, at least about 6 mm, at least about 7 mm, at least about 8 mm, at least about 9 mm, at least about 10 mm, at least about 1 1 mm, at least about 12 mm, at least about 13 mm, at least about 14 mm, at least about 15 mm, at least about 16 mm, at least about 17 mm, at least about 18 mm, at least about 19 mm, at least about 20 mm, at least about 21 mm, at least about 22 mm or at least about 23 mm from the distal end of the needle 104 in the storage position.
  • the distal end of the needle guard 106 is between about 3 mm and about 23 mm, between about 4 mm and about 22 mm, between about 5 mm and about 21 mm, between about 6 mm and about 20 mm, between about 7 mm and about 19 mm, between about 8 mm and about 18 mm, between about 9 mm and about 17 mm, between about 10 mm and about 16 mm, between about 11 mm and about 15 mm or between about 12 mm and about 14 mm from the distal end of the needle 104 in the storage position.
  • the energy source 114 is prevented from moving the ram 112 distally relative to the latch 110 and the housing 100 due to engagement of the first latch member 212 and the ram aperture 234.
  • the forces of the energy source 114 and the angled surface of the first protrusion 218 are prevented by the trigger body 176 from moving the first latch member from the first relaxed position to the first flexed position.
  • the injector 10 in a pre-firing state, may have the cap 120 removed from the front housing 116.
  • the cap collar 150 may remain disposed in the housing collar 154.
  • the needle guard 106 may be in an extended position when the cap 120 is removed from the housing 100.
  • the needle guard may extend the third distance in the storage position and the first distance in the extended position.
  • the ram aperture 234 may receive at least a portion of the first protrusion 218 when the needle guard 106 is in the extended position.
  • the energy source 114 is prevented from moving the ram 112 distally relative to the latch 110 and the housing 100 due to engagement of the first latch member 212 and the ram aperture 234.
  • the forces of the energy source 114 and the angled surface of the first protrusion 218 are prevented by the trigger body 176 from moving the first latch member 212 from the first relaxed position to the first flexed position.
  • the injector 10 in the triggering state, may have the needle guard 106 moved proximally into a retracted position.
  • the needle guard 106 may be moved proximally into the retracted position by the user pressing the injector 10 distally toward the injection site.
  • the needle guard 106 may extend approximately 8 mm from the front housing 116 when the needle guard 106 is in the retracted position.
  • the needle guard 106 may extend between about 5 mm and about 10 mm from the front housing 116 when the needle guard 106 is in the retracted position.
  • the needle guard 106 may extend less than about 5 mm, less than about 6 mm, less than about 7 mm, less than about 8 mm, less than about 9 mm or less than about 10 mm from the front housing 1 16 when the needle guard 106 is in the retracted position. In some embodiments, the needle guard 106 may extend between about 5 mm and about 10 mm, between about 6 mm and about
  • the needle 104 may extend through the guard aperture 136 approximately
  • Proximal movement of the needle guard 106 from the extended position to the retracted position may align the trigger aperture 182 with the first latch member 212.
  • the forces of the energy source 114 and the angled surface of the first protrusion 218 are thereby allowed to move the first latch member 212 from the first relaxed position to the first flexed position.
  • the energy source 114 may be allowed to urge the ram 112 distally relative to the latch 110 and relative to the housing 100 when the injector is in the triggering state.
  • the needle guard return 236 may be prevented from moving the trigger 108 and the needle guard 106 distally by the first latch member 212 in the first flexed position.
  • the needle guard 106 is moveable proximally at least 2 mm when the first protrusion 218 is in the flexed position to allow the needle 104 to reach the intended depth for delivery of the medicament.
  • distal movement of the ram 112 may cause the ram 112 to engage the plunger 130, thereby moving the plunger 130 relative to the medicament container 102. Movement of the plunger 130 relative to the medicament container 102 may generate pressure within the container portion 128 sufficient to eject the volume of the medicament from the medicament container 102 through a needle 104 disposed thereon.
  • the ram 112 may be moved distally such that the ram notch 232 aligns with the first protrusion 218 thereby allowing at least a portion of the first protrusion 218 to extend therein.
  • the first protrusion 218 being received in the ram notch 232 may allow the first latch member 212 to move from the first flexed position to the first relaxed position.
  • the needle guard return 236 may be allowed to urge the trigger 108 and the needle guard 106 distally toward a lockout position when the first latch member 212 is in the first relaxed position.
  • the trigger 108 may be engageable with the ram 112 such that movement of the needle guard 106 from the retracted position to the lockout position is dependent upon the position of the ram 112 relative to the latch 110.
  • the ram 112 may prevent the needle guard 106 from moving into the lockout position during delivery of the medicament. This may be useful if the needle 104 is accidentally or prematurely removed from the injection site.
  • the latch engagement feature 184 may engage the second protrusion 226 of the second latch member 222.
  • the second latch member 222 in the second relaxed position, may prevent the trigger 108 and needle guard 106 from moving distally into the lockout position.
  • the forces produced by the needle guard return 236 and the angled surface of the second protrusion 226 and latch engagement feature 184 may be prevented by the ram 112 from moving the second latch member 222 from the second relaxed position to the second flexed position.
  • the ram notch 232 may align with the second latch member 222.
  • the forces produced by the needle guard return 236 and the angled surface of the second protrusion 226 and latch engagement feature 184 move the second latch member 222 from the second relaxed position to the second flexed position.
  • the second latch member 222 being received in the ram notch 232 may allow the latch engagement feature 184 to move distally past the second protrusion 226, thereby allowing the trigger 108 and needle guard 106 to move into the lockout position.
  • the ram 112 may move distally at least 90% of the way through the medicament container 102 before the second protrusion 226 is received in the ram notch 232.
  • FIG. 18 there is shown a second embodiment of the front housing 116, generally designated 1116.
  • the front housing 1116 is similar to the first embodiment of the front housing 116 except that the front housing 1116 is configured to receive a smaller medicament container (not shown).
  • the medicament container may be configured to hold, for example, 5 mL of a medicament.
  • the window 1122 may be shorter than window 122 along the longitudinal axis AL.
  • injector 10 may include a dose status indicator.
  • FIG. 21 there is shown a second embodiment of the rear housing 118, generally designated 2118.
  • the rear housing 2118 is similar to the first embodiment of the rear housing 118 except that the rear housing 2118 may include a window 2238 defined thereon.
  • the window 2238 is defined on the front housing 2116.
  • the window 2238 is window 2122.
  • the window 2238 may be configured to enable a user to view movement of the ram 2112 relative to the rear housing 2118 during an injection.
  • the window 2238 may be a generally ovular shape extending along the longitudinal axis AL. In some embodiments, the window 2238 may be a rectangular shape.
  • the window 2238 may include a status prong 2240 extending therefrom.
  • the status prong 2240 may extend radially inward toward a center of the window 2238 and may come to a point at an end.
  • the status prong 2240 may be a generally triangular member.
  • the status prong 2240 may be a generally right triangle such that a proximal side of the status prong 2240 is generally perpendicular to the longitudinal axis AL.
  • the window 2238 may include two status prongs 2240 extending toward each other. In some embodiments, the window 2238 includes only one status prong 2240.
  • a second embodiment of the trigger 108 is similar to the first embodiment of the trigger 108 except that trigger 1108 may include a trigger band 1181 disposed thereon.
  • the trigger band 1181 may extend around a circumference of the trigger body 1176.
  • the trigger band 1181 extends around a portion of the trigger body 1176.
  • the trigger 1108 includes more than one trigger band 1181.
  • the trigger band 1181 may be made from a metal material.
  • the trigger band 1181 is made from a plastic or composite material with greater hoop strength than that of the trigger body 1176.
  • the trigger band 1181 may be located proximate the proximal end of the trigger body 1176. In some embodiments, the trigger band 1181 is spaced apart from the proximal end of the trigger body 1176. The trigger band 1181 may provide improved rigidity of the trigger body 1176 by increasing the hoop strength of the trigger 1108, thereby preventing deformation of the trigger body 1176 under the axial forces produced by the first latch member 1212 prior to use of injector 1010. The trigger band 1181 may be located on a different component of the injector 1010. In some embodiments, the trigger band 1181 is located on the housing 1100, on the trigger 1108, on the latch 1110 or on the ram 1112. In an embodiment that includes a button, for example a button- actuated autoinjector, the trigger band 1181 may be located on the button.
  • the trigger band 1181 may be coupled to the trigger body 1176 with an adhesive or welding. In some embodiments, the trigger band 1181 is integrally formed on the trigger body 1176. In some embodiments, the trigger body 1176 may include a burr 1183 (not shown) extending radially from the proximal end thereof. The burr 1 183 may extend around at least a portion of the circumference of the proximal end of the trigger 1108. In some embodiments, more than one burr 1183 is spaced apart around the circumference of the proximal end of the trigger 1108. The trigger band 1181 may be prevented from moving proximally relative to the trigger 1108 past the burr 1183. The trigger band 1181 may be rotatable relative to the trigger body 1176.
  • the trigger band 1181 may be configured to resist up to 30 lbs of force for up to three years. In some embodiments, the trigger band 1181 resists at least 8 lbs of force, at least 9 lbs of force, at least 10 lbs of force, at least 11 lbs of force, at least 12 lbs of force, at least 13 lbs of force, at least 14 lbs of force, at least 15 lbs of force, at least 16 lbs of force, at least 17 lbs of force, at least 18 lbs of force, at least 19 lbs of force, at least 20 lbs of force, at least 21 lbs of force, at least 22 lbs of force, at least 23 lbs of force, at least 24 lbs of force, at least 25 lbs of force, at least 26 lbs of force, at least 27 lbs of force, at least 28 lbs of force, at least 29 lbs of force, or at least 30 lbs of force for up to three years.
  • the trigger band 1181 resists between 8-30 lbs of force, between 9-29 lbs of force, between 10-28 lbs of force, between 11-27 lbs of force, between 12-26 lbs of force, between 13-25 lbs of force, between 14-24 lbs of force, between 15-23 lbs of force, between 16-22 lbs of force, between 17-21 lbs of force, or between 18-20 lbs of force for up to three years.
  • the trigger band 1181 may be configured to resist deformation forces in temperatures up to 40° C for up to three years. In some embodiments, the trigger band 1181 resists deformation forces in temperatures of at least 20° C, at least 25° C, at least 30° C, at least 35° C, at least 40° C, at least 45° C, at least 50° C, at least 55° C, or at least 60° C for up to three years. In some embodiments, the trigger band 1181 resists deformation forces in temperatures between 20° C and 60° C, between 25° C and 55° C, between 30° C and 50° C, or between 35° C and 45° C for up to three years.
  • a third embodiment of the trigger 108 is shown a third embodiment of the trigger 108, generally designated 2108.
  • the trigger 2108 is similar to the second embodiment of the trigger 1108 except that trigger 2108 may include a trigger band 2181 disposed on an interior thereof.
  • the trigger band 2181 may be configured to engage directly with the first latch member 2212 of the latch 2110 to reduce or prevent deformation of the trigger body 2176.
  • the trigger band 2181 may be disposed on an interior of the trigger body 2176.
  • the trigger 2108 includes a trigger band 2181 disposed on an interior of the trigger body 2176 and a trigger ring 2180 disposed on an exterior of the trigger body 2176.
  • the trigger band 2181 may be located on a different component of the injector 2010.
  • the trigger band 2181 is located on the housing 2100, on the trigger 2108, on the latch 21 10 or on the ram 2112.
  • the trigger band 2181 may be located on the button.
  • the trigger band 2181 may be located proximate the proximal end of the trigger body 2176. In some embodiments, the trigger band 2181 is spaced apart from the proximal end of the trigger body 2176. The trigger band 2181 may dissipate the axial forces produced by the first latch member 2212 prior to use of injector 2010. The trigger band 2181 may provide improved rigidity of the trigger body 2176 by increasing the hoop strength of the trigger 2108, thereby preventing deformation of the trigger body 2176 under the axial forces produced by the first latch member 2212 prior to use of injector 2010. The trigger band 2181 may be located on a different component of the injector 2010.
  • the trigger band 2181 is located on the housing 2100, on the trigger 2108, on the latch 2110 or on the ram 2112. In an embodiment that includes a button, for example a button-actuated autoinj ector, the trigger band 2181 may be located on the button. [00136] Referring to Figs. 20A-20C, the trigger band 2181 may be prevented from longitudinal movement relative to the trigger body 2176. In some embodiments, the trigger band 2181 is coupled to the trigger body 2176 with an adhesive or welding. In some embodiments, the trigger band 2181 is integrally formed on the trigger body 2176. In some embodiments, the trigger body 2176 may include a burr 2183 (Figs. 21B-20C) extending radially thereof.
  • the burr 2183 may extend around at least a portion of the circumference of the trigger body 2176. In some embodiments, more than one burr 2183 is spaced apart around the circumference of the trigger body 2176.
  • the trigger band 2181 may include a band groove 2185 defined thereon.
  • the band groove 2185 may extend around at least a portion of the circumference of an exterior of the trigger band 2181. In some embodiments, the band groove 2185 extends around the circumference of the trigger band 2181.
  • the band groove 2185 may be shaped and sized to receive at least a portion of the burr 2183 therein.
  • the trigger band 2181 may be prevented from moving proximally relative to the trigger 2108 past the burr 2183.
  • the trigger band 2181 may be allowed to rotate relative to the trigger body 2176 but may be prevented from moving longitudinally relative to the trigger body 2176 by the engagement of the band groove 2185 and the burr 2183.
  • the ram 2112 may include a dose indicator 2242 defined thereon.
  • the dose indicator 2242 may be a line that extends around at least a portion of the circumference of the ram 2112. In some embodiments, the dose indicator 2242 extends around only a portion of the ram 2112.
  • the dose indicator 2242 may be a solid line. In some embodiments, the dose indicator 2242 is a broken line.
  • the dose indicator 2242 may be colored such that a user can easily identify the dose indicator 2242 on the ram 2112 during an injection.
  • the dose indicator 2242 may be positioned proximally relative to the window 2238 and may not be visible to a user. In some embodiments, the dose indicator 2242 may be visible at a proximal end of the window 2238 when the injector 10 is in the initial state. During an injection, as the ram 2112 moves distally relative to the rear housing 2118, the dose indicator 2242 may move relative to the window 2238 toward the status prong 2240. This may allow a user to monitor the status and progress of a dose through visual inspection. Referring to Fig. 21, the dose indicator 2242 may be aligned with the status prong 2240 when delivery of the dose is complete.
  • the dose indicator 2242 may be aligned with the proximal side of the status prong 2240 when delivery of the dose is complete.
  • the window 2238 may be integrally formed in the rear housing 2118. In some embodiments, the window 2238 may be removably coupled to the rear housing 2118. In some embodiments, the window 2238 may be removeable and replaceable with any of the windows shown in Figs. 22-29. [00139] Referring to Fig. 22, there is shown a third embodiment of the rear housing 118, generally designated 3118.
  • the rear housing 3118 is similar to the second embodiment of the rear housing 2118 except that the rear housing 3118 may include a ram 3112 having a dose indicator 3242 and a delivery indicator 3243 defined thereon.
  • the dose indicator 3242 may be a line that extends around at least a portion of the circumference of the ram 3112. In some embodiments, the dose indicator 3242 extends around only a portion of the ram 3112. The dose indicator 3242 may be a solid line. In some embodiments, the dose indicator 3242 is a broken line. The dose indicator 3242 may be colored such that a user can easily identify the dose indicator 3242 on the ram 3112 during an injection.
  • the delivery indicator 3243 may be an indicia on the ram 3112 that extends along the longitudinal axis AL and may be visible by a user through the window 3238.
  • the delivery indicator 3243 may extend along a length of the ram 3112. In some embodiments, the delivery indicator 3243 extends along a portion of the ram 3112.
  • the delivery indicator 3243 may be a broken line such that movement of the ram 3112 relative to the window 3238 and the status prong 3240 may be visible by a user during delivery of the dose.
  • the dose indicator 3242 may be positioned in between two portions of the delivery indicator 3243 to enable a user to view the dose indicator separately from the delivery indicator 3243.
  • the dose indicator 3242 may be positioned proximally relative to the window 3238 and may not be visible to a user. In some embodiments, the dose indicator 3242 may be visible at a proximal end of the window 3238 when the injector 10 is in the initial state. During an injection, as the ram 3112 moves distally relative to the rear housing 3118 the dose indicator 3242 may move relative to the window 3238 toward the status prong 3240. This may allow a user to monitor the status and progress of a dose through visual inspection. Referring to Fig. 22, the dose indicator 3242 may be aligned with the status prong 3240 when delivery of the dose is complete. The dose indicator 3242 may be aligned with the proximal side of the status prong 3240 when delivery of the dose is complete.
  • FIG. 23 there is shown a fourth embodiment of the rear housing 118, generally designated 4118.
  • the rear housing 4118 is similar to the third embodiment of the rear housing 3118 except that rear housing 4118 may include a ram 4112 having a dose indicator 4242 and a delivery indicator 4243 defined thereon.
  • the dose indicator 4242 may be a line that extends around at least a portion of the circumference of the ram 4112. In some embodiments, the dose indicator 4242 extends around only a portion of the ram 4112.
  • the dose indicator 4242 may be a solid line. In some embodiments, the dose indicator 4242 is a broken line.
  • the dose indicator 4242 may be defined at a proximal side and a distal side by the delivery indicator 4243. As such, the ram 4112 may be colored such that a user can easily identify the dose indicator 4242 during an injection.
  • the delivery indicator 4243 may be an indicia on the ram 4112 that extends along the longitudinal axis AL and may be visible by a user through the window 4238.
  • the delivery indicator 4243 may extend around at least a portion of the circumference of the ram 4112. In some embodiments, the delivery indicator 4243 extends around only a portion of the ram 4112.
  • the delivery indicator 4243 may extend along a length of the ram 4112. In some embodiments, the delivery indicator 4243 extends along a portion of the ram 4112.
  • the delivery indicator 4243 may be a cross-hatched indicia such that movement of the ram 4112 relative to the window 4238 and the status prong 4240 may be visible by a user during delivery of the dose.
  • the thickness of the lines, the angle of the lines, and the spacing between the lines of the delivery indicator 4243 may be modulated to offer sufficient indicia for a user.
  • the dose indicator 4242 may be positioned in between two portions of the delivery indicator 4243 to enable a user to view the dose indicator separate from the delivery indicator 4243.
  • the dose indicator 4242 may be positioned proximally relative to the window 4238 and may not be visible to a user. In some embodiments, the dose indicator 4242 may be visible at a proximal end of the window 4238 when the injector 10 is in the initial state. During an injection, as the ram 4112 moves distally relative to the rear housing 4118 the dose indicator 4242 may move relative to the window 4238 toward the status prong 4240. This may allow a user to monitor the status and progress of a dose through visual inspection. Referring to Fig. 23, the dose indicator 4242 may be aligned with the status prong 4240 when delivery of the dose is complete. The dose indicator 4242 may be aligned with the proximal side of the status prong 4240 when delivery of the dose is complete.
  • FIG. 24 there is shown a fifth embodiment of the rear housing 118, generally designated 5118.
  • the rear housing 5118 is similar to the fourth embodiment of the rear housing 4118 except that rear housing 5118 may include a ram 5112 having a dose indicator 5242 and a delivery indicator 5243 defined thereon and the window 5238 may have a status prong 5240 defined on a perimeter thereof.
  • the status prong 5240 may extend radially inward toward a center of the window 5238 and may come to a point at an end.
  • the status prong 5240 may be a generally triangular member.
  • the status prong 5240 may be a generally right triangle such that a proximal side of the status prong 5240 is generally perpendicular to the longitudinal axis AL.
  • the window 5238 may include two status prongs 5240 pointing toward each other. In some embodiments, the window 5238 includes only one status prong 5240.
  • the dose indicator 5242 may be an arrow that is positioned on the ram 5112 and extends radially out from a center of the ram 5112. In some embodiments, the dose indicator 5242 extends around a portion of the ram 51 12. The dose indicator 5242 may be two arrows that extend radially apart from the center of the ram 5112. In some embodiments, the dose indicator 5242 is two arrows separated by the delivery indicator 5243. In some embodiments, the dose indicator 5242 is a line. The dose indicator 5242 may be colored such that a user can easily identify the dose indicator
  • the delivery indicator 5243 may be an indicia on the ram 5112 that extends along the longitudinal axis AL and may be visible by a user through the window 5238.
  • the delivery indicator 5243 may extend around at least a portion of the circumference of the ram 5112. In some embodiments, the delivery indicator 5243 extends around only a portion of the ram 5112.
  • the delivery indicator 5243 may extend along a length of the ram 5112. In some embodiments, the delivery indicator 5243 extends along a portion of the length of the ram 5112.
  • the delivery indicator 5243 may be an indicia on the ram 5112 that extends along the longitudinal axis AL and may be visible by a user through the window 5238.
  • the delivery indicator 5243 may extend around at least a portion of the circumference of the ram 5112. In some embodiments, the delivery indicator 5243 extends around only a portion of the ram 5112.
  • the delivery indicator 5243 may extend along a length of the ram 5112. In some embodiments, the delivery indicator 5
  • the delivery indicator 5243 may be a checkered indicia such that movement of the ram 5112 relative to the window 5238 and the status prong 5240 may be visible by a user during delivery of the dose.
  • the thickness of the lines, the angle of the lines and the spacing between the lines of the delivery indicator 5243 may be modulated to offer sufficient indicia for a user.
  • the delivery indicator 5243 may be positioned in between two arrows of the dose indicator 5242 to enable a user to view the dose indicator 5242 separate from the delivery indicator 5243.
  • the dose indicator 5242 may be positioned proximally relative to the window 5238 and may not be visible to a user. In some embodiments, the dose indicator 5242 may be visible at a proximal end of the window 5238 when the injector 10 is in the initial state. During an injection, as the ram 5112 moves distally relative to the rear housing 5118 the dose indicator 5242 may move relative to the window 5238 toward the status prong 5240. This may allow a user to monitor the status and progress of a dose through visual inspection. Referring to Fig. 24, the dose indicator 5242 may be aligned with the status prong 5240 when delivery of the dose is complete. The dose indicator 5242 may be aligned with the proximal side of the status prong 5240 when delivery of the dose is complete.
  • FIG. 25 there is shown a sixth embodiment of the rear housing 118, generally designated 6118.
  • the rear housing 6118 is similar to the fifth embodiment of the rear housing 5118 except that rear housing 6118 may include a ram 6112 having a dose indicator 6242 defined thereon and the window 6238 may have a status aperture 6241 extending across the window 6238.
  • the window 6238 may include a status aperture 6241 defined thereon and extending across at a portion of the window 6238 between a proximal end and a distal end.
  • the status aperture 6241 may be shaped and sized such that a user can view the dose indicator 6242 therethrough when the delivery of a dose is complete.
  • the status aperture 6241 may extend radially across the window 6238. Tn some embodiments, the status aperture 6241 extends longitudinally across the window 6238.
  • the dose indicator 6242 may be a circle that is positioned on the ram 6112.
  • the dose indicator 6242 may be located at a center of the ram 6112 relative to the window 6238.
  • the dose indicator 6242 is a square or another polygonal shape.
  • the dose indicator 6242 may be colored such that a user can easily identify the dose indicator 6242 during an injection.
  • the dose indicator 6242 may be positioned proximally relative to the window 6238 and may not be visible to a user. In some embodiments, the dose indicator 6242 may be visible at a proximal end of the window 6238 when the injector 10 is in the initial state. During an injection, as the ram 6112 moves distally relative to the rear housing 6118 the dose indicator 6242 may move relative to the window 6238 toward the status aperture 6241. This may allow a user to monitor the status and progress of a dose through visual inspection. Referring to Fig. 25, the dose indicator 6242 may be aligned with and visible through the status aperture 6241 when delivery of the dose is complete. The dose indicator 6242 may be aligned with a center of the status aperture 6241 when delivery of the dose is complete.
  • FIG. 26 there is shown a seventh embodiment of the rear housing 118, generally designated 7118.
  • the rear housing 7118 is similar to the sixth embodiment of the rear housing 6118 except that rear housing 7118 may include a ram 7112 having a dose indicator 7242 defined thereon and the window 7238 may have a status beam 7247 extending across the window 7238.
  • the window 7238 may include a status beam 7247 defined thereon extending across a portion of the window 7238 between a proximal end and a distal end.
  • the status beam 7247 may be shaped and sized such that a user can view the dose indicator 7242 positioned proximate the status beam 7247 when the delivery of a dose is complete.
  • the status beam 7247 may extend radially across the window 7238.
  • the dose indicator 7242 may be an arrow that is positioned on the ram 7112 and extends longitudinally toward the proximal end or distal end of the ram 7112. In some embodiments, the dose indicator 7242 extends a portion of a length of the ram 7112. The dose indicator 7242 may be two arrows that extend longitudinally toward each other on the ram 7112. In some embodiments, the dose indicator 7242 is two arrows separated by a gap sized and shaped to allow the status beam 7247 to be viewed therebetween. The dose indicator 7242 may be colored such that a user can easily identify the dose indicator 7242 during an injection.
  • the dose indicator 7242 may be positioned proximally relative to the window 7238 and may not be visible to a user. In some embodiments, the dose indicator 7242 may be visible at a proximal end of the window 7238 when the injector 10 is in the initial state. During an injection, as the ram 7112 moves distally relative to the rear housing 7118 the dose indicator 7242 may move relative to the window 7238 toward the status beam 7247. This may allow a user to monitor the status and progress of a dose through visual inspection. Referring to Fig. 26, the dose indicator 7242 may be aligned with the status beam 7247 when delivery of the dose is complete. The dose indicator 7242 may be an arrow positioned proximate and pointing toward the status beam 7247 when delivery of the dose is complete.
  • FIG. 27 there is shown an eighth embodiment of the rear housing 118, generally designated 8118.
  • the rear housing 8118 is similar to the seventh embodiment of the rear housing 7118 except that rear housing 8118 may include a ram 8112 having a delivery indicator 8243 defined thereon.
  • the delivery indicator 8243 may be an indicia on the ram 8112 that extends along the longitudinal axis AL and may be visible by a user through the window 8238.
  • the delivery indicator 8243 may extend around the circumference of the ram 8112. In some embodiments, the delivery indicator 8243 extends around only a portion of the ram 8112.
  • the delivery indicator 8243 may extend along a length of the ram 8112.
  • the delivery indicator 8243 extends along a portion of the length of the ram 8112.
  • the delivery indicator 8243 may be a cross-hatched indicia such that movement of the ram 8112 relative to the window 8238 may be visible by a user during delivery of the dose.
  • the thickness of the lines, the angle of the lines and the spacing between the lines of the delivery indicator 8243 may be modulated to offer sufficient indicia for a user.
  • the delivery indicator 8243 may be positioned proximally relative to the window 8238 and may not be visible to a user. In some embodiments, the delivery indicator 8243 may be visible at a proximal end of the window 8238 when the injector 10 is in the initial state. During an injection, as the ram 8112 moves distally relative to the rear housing 8118 the delivery indicator 8243 may move relative to the window 8238. This may allow a user to monitor the status and progress of a dose through visual inspection. Referring to Fig. 27, the delivery indicator 8243 may completely occlude the window 8238 when delivery of the dose is complete.
  • FIG. 28 there is shown a ninth embodiment of the rear housing 118, generally designated 9118.
  • the rear housing 9118 is similar to the eighth embodiment of the rear housing 8118 except that rear housing 9118 may include a ram 9112 having a delivery message 9251 defined thereon.
  • the delivery message 9251 may be an indicia on the ram 9112 that can be read by a user to determine a dose status.
  • the delivery message 9251 may be the word “DONE” or similar.
  • the delivery message 9251 may extend around the circumference of the ram 9112. In some embodiments, the delivery message 9251 extends around only a portion of the ram 9112.
  • the delivery message 9251 may be a word or icon disposed on the ram 9112 such that movement of the ram 9112 relative to the window 9238 may be visible by a user during delivery of the dose.
  • the thickness of the letters and the spacing between the letters or icons of the delivery message 9251 may be modulated to offer sufficient indicia for a user.
  • the delivery message 9251 may be positioned proximally relative to the window 9238 and may not be visible to a user. In some embodiments, the delivery message 9251 may be visible at a proximal end of the window 9238 when the injector 10 is in the initial state. During an injection, as the ram 9112 moves distally relative to the rear housing 9118, the delivery message 9251 may move relative to the window 9238 toward the distal end thereof. This may allow a user to monitor the status and progress of a dose through vi sual inspection. Referring to Fig. 28, the delivery message 9251 may be proximate the distal end of the window 8238 when delivery of the dose is complete.
  • FIG. 29 there is shown a tenth embodiment of the rear housing 118, generally designated 10118.
  • the rear housing 10118 is similar to the ninth embodiment of the rear housing 9118 except that rear housing 10118 may include a ram 10112 having a dose indicator 10242, a delivery indicator 10243 and a delivery message 10251 defined thereon and the window 10238 may have a status recess 10249 defined on a perimeter thereof.
  • the window 10238 is defined on the front housing 101 16.
  • the window 10238 is window 10122.
  • the window 10238 may be configured to enable a user to view movement of the ram 10112 relative to the rear housing 10118 during an injection.
  • the window 10238 may be a generally ovular shape extending along the longitudinal axis AL.
  • the window 10238 may have a rounded proximal end and a flat distal end with a status recess 10249 extending from the distal end.
  • the status recess 10249 may be a generally circular member and may extend distally from the distal end of the window 10238.
  • the status recess 10249 may be shaped and sized to allow a user to view the dose indicator therein upon completion of delivery of a dose.
  • the window 10238 may be a rectangular shape.
  • the dose indicator 10242 may be a circle that is positioned on the ram 10112.
  • the dose indicator 10242 may be located at a center of the ram 10112 relative to the window 10238.
  • the dose indicator 10242 is a square or another polygonal shape.
  • the dose indicator 10242 may be colored such that a user can easily identify the dose indicator 10242 during an injection.
  • the delivery indicator 10243 may be an indicia on the ram 10112 that extends along the longitudinal axis AL and may be visible by a user through the window 10238.
  • the delivery indicator 10243 may extend along a length of the ram 10112. In some embodiments, the delivery indicator 10243 extends along a portion of the length of the ram 10112.
  • the delivery indicator 10243 may be a line with a plurality of waves or squiggles such that movement of the ram 10112 relative to the window 10238 may be visible by a user during delivery of the dose.
  • the thickness of the line and the spacing between the waves of the delivery indicator 10243 may be modulated to offer sufficient indicia for a user.
  • the delivery message 10251 may be an indicia on the ram 10112 that can be read by a user to determine a dose status.
  • the delivery message 10251 may be the word “DONE” or similar.
  • the delivery message 10251 may extend around the circumference of the ram 10112. In some embodiments, the delivery message 10251 extends around only a portion of the ram 10112.
  • the delivery message 10251 may be a word or icon disposed on the ram 10112 such that movement of the ram 10112 relative to the window 10238 may be visible by a user during delivery of the dose.
  • the thickness of the letters and the spacing between the letters or icons of the delivery message 10251 may be modulated to offer sufficient indicia for a user.
  • At least one of the dose indicator 10242, the delivery message 10251 and the delivery indicator 10243 may be positioned proximally relative to the window 10238 and may not be visible to a user. In some embodiments, at least one of dose indicator 10242, the delivery message 10251 and the delivery indicator 10243 may be visible at a proximal end of the window 10238 when the injector 10 is in the initial state.
  • the dose indicator 10242, the delivery message 10251 and the delivery indicator 10243 may move relative to the window 10238.
  • the dose indicator 10232 may move toward the status recess 10249 extending from the distal end of the window 10238.
  • the delivery message 10251 may move toward the distal end of the window 10238. This may allow a user to monitor the status and progress of a dose through visual inspection. Referring to Fig. 29, the dose indicator 10242 may be aligned with and visible through the status recess 10249 when delivery of the dose is complete. The delivery message 10251 may be positioned proximate the distal end of the window 10238 when delivery of the dose is complete.
  • the term “about,” as used herein, in conjunction with a numeral refers to a value that may be ⁇ 0.01% (inclusive), ⁇ 0.1% (inclusive), ⁇ 0.5% (inclusive), ⁇ 1% (inclusive) of that numeral, ⁇ 2% (inclusive) of that numeral, ⁇ 3% (inclusive) of that numeral, ⁇ 5% (inclusive) of that numeral, ⁇ 10% (inclusive) of that numeral, or ⁇ 15% (inclusive) of that numeral. It should further be appreciated that when a numerical range is disclosed herein, any numerical value falling within the range is also specifically disclosed.

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Abstract

An injector includes a housing, a medicament container disposed within the housing, a needle, a needle guard moveable relative to the housing from an extended position to a retracted position to a lockout position. A trigger is disposed within the housing and is coupled to the needle guard. A latch is disposed within the housing and engageable with the trigger. A ram movable relative to the latch, and an energy source is configured to urge the ram distally relative to the latch along the longitudinal axis. The trigger is engageable with the ram such that movement of the needle guard from the retracted position to the lockout position is dependent upon the position of the ram relative to the latch.

Description

TITLE
[0001] Autoinjector
CROSS-REFERENCE TO RELATED APPLICATIONS
[0002] This application claims the benefit ofU.S. Provisional Patent Application No. 63/567,105, filed March 19, 2024, entitled “Autoinjector”, and U.S. Provisional Patent Application No. 63/758,264, filed February 13, 2025, entitled “Autoinjector”, each of which is incorporated by reference herein in its entirety.
TECHNICAL FIELD
[0003] The present disclosure generally relates to autoinjectors and, in some embodiments, needle guard actuated autoinjectors for the delivery of large volumes of medicament for sub skin surface penetration.
SUMMARY
[0004] In one embodiment, there is an injector including a housing having a proximal end, a distal end, and a longitudinal axis extending between the proximal end and the distal end, a medicament container disposed within the housing and containing a volume of a medicament, a needle coupled to a distal end of the medicament container and in fluid communication therewith, a needle guard at least partially disposed within the distal end of the housing and moveable relative to the housing along the longitudinal axis from an extended position where the needle guard extends distally from the housing to cover the needle, to a retracted position where the needle guard is moved proximally to at least partially expose the needle, to a lockout position where the needle guard extends distally from the housing to cover the needle, a trigger disposed within the housing and coupled to the needle guard, a latch disposed within the housing, the latch configured to engage the trigger, a ram movable relative to the latch, and an energy source configured to urge the ram distally relative to the latch along the longitudinal axis. In some embodiments, the trigger is engageable with the ram such that movement of the needle guard from the retracted position to the lockout position is dependent upon the position of the ram relative to the latch.
[0005] In some embodiments, the latch includes a latch body, a first latch member moveable between a first flexed position wherein the first latch member is flexed radially outward relative to the latch body and a first relaxed position wherein the first latch member is generally flush with the latch body, and a second latch member moveable between a second flexed position wherein the second latch member is flexed radially inward relative to the latch body and a second relaxed position wherein the second latch member is generally flush with the latch body.
[0006] In some embodiments, the first latch member in the first flexed position prevents movement of the needle guard from the retracted position toward the lockout position. In some embodiments, movement of the ram distally past the first latch member allows the first latch member to move from the first flexed position to the first relaxed position thereby allowing the needle guard to move from the retracted position toward the lockout position. In some embodiments, the second latch member in the second relaxed position prevents movement of the needle guard into the lockout position.
[0007] In some embodiments, movement of the ram distally past the second latch member allows the second latch member to move from the second relaxed position to the second flexed position thereby allowing the needle guard to move into the lockout position. In some embodiments, at least a portion of the trigger is engaged between the latch and the medicament container when the needle guard is in the lockout position, thereby preventing movement of the needle guard along the longitudinal axis.
[0008] In some embodiments, the first latch member includes a first flexible arm extending along the longitudinal axis and a first protrusion extending radially inward therefrom. In some embodiments, ram includes a ram body. In some embodiments, a ram aperture extends through the ram body, the ram aperture receiving at least a portion of the first protrusion when the needle guard is in the extended position. In some embodiments, the ram aperture receiving the first protrusion prevents movement of the ram relative to the latch and relative to the housing.
[0009] In some embodiments, movement of the needle guard from the extended position to the retracted position aligns a window of the trigger with the first latch member, thereby allowing the first latch member to move into the first flexed position and allowing movement of the ram relative to the latch. In some embodiments, the medicament container includes a plunger disposed therein, and wherein the ram engages the plunger thereby moving the plunger relative to the medicament container. In some embodiments, movement of the plunger relative to the medicament container ejects the volume of the medicament from the medicament container through a needle disposed at a distal end thereof. In some embodiments, the second latch member includes a second flexible arm extending along the longitudinal axis and a second protrusion extending radially outward therefrom. [0010] In some embodiments, the injector further includes a needle guard return configured to bias the needle guard distally relative to the housing. In some embodiments, the needle guard return is disposed between a proximal end of the trigger and a distal end of the latch.
[0011] In some embodiments, a distal end of the needle guard extends a first distance from the housing in the extended position, wherein the distal end of the needle guard extends a second distance from the housing in the lockout position, and wherein the second distance is greater than the first distance. In some embodiments, the latch is fixed relative to the housing, and wherein the medicament container is fixed relative to the housing. In some embodiments, the volume of the medicament is at least 10 mL.
[0012] In some embodiments, the trigger includes a trigger ring disposed thereon configured to prevent radial deformation of the trigger. In some embodiments, the trigger ring is disposed on an outer surface of the trigger. In some embodiments, the trigger ring is disposed on an inner surface of the trigger.
[0013] In some embodiments, the injector further includes a window extending through the housing and a dose indicator disposed on the ram. In some embodiments, the dose indicator is viewable through the window during delivery of a dose of the medicament to a subject. In some embodiments, the ram and dose indicator are moveable relative to the window when the energy source urges the ram distally relative to the latch during delivery of the dose of the medicament to a subject. In some embodiments, the window includes a status indicator disposed thereon, where the dose indicator is positioned proximate the status indicator when delivery of the dose of the medicament is complete. In some embodiments, the dose indicator is aligned with the status indicator when delivery of the dose of the medicament is complete.
[0014] In another embodiment, there is an injector including a housing having a proximal end, a distal end and a longitudinal axis extending between the proximal end and the distal end, a medicament container disposed within the housing and containing a volume of a medicament, a needle coupled to a distal end of the medicament container and in fluid communication therewith, a needle guard at least partially disposed within the distal end of the housing and moveable relative to the housing along the longitudinal axis from an extended position wherein the needle guard extends distally from the housing to cover the needle, to a retracted position wherein the needle guard is moved proximally to at least partially expose the needle, to a lockout position wherein the needle guard extends distally from the housing to cover the needle, a trigger disposed within the housing and coupled to the needle guard, a latch disposed within the housing, the latch configured to engage the trigger and including a latch body, a first latch member moveable between a first flexed position wherein the first latch member is flexed radially outward relative to the latch body and a first relaxed position wherein the first latch member is generally flush with the latch body, and a second latch member moveable between a second flexed position wherein the second latch member is flexed radially inward relative to the latch body and a second relaxed position wherein the second latch member is generally flush with the latch body, a ram movable relative to the latch, an energy source configured to urge the ram distally along the longitudinal axis, and a needle guard return configured to bias the needle guard distally relative to the housing.
[0015] In some embodiments, the trigger is engageable with the ram such that movement of the needle guard from the retracted position to the lockout position is dependent upon the position of the ram. In some embodiments, the needle guard return is disposed between a proximal end of the trigger and a distal end of the housing.
[0016] In another embodiment, there is an injector including a housing having a proximal end, a distal end, and a longitudinal axis extending between the proximal end and the distal end, a housing collar defined on the housing proximate the distal end and a cap removably coupled to the distal end of the housing, the cap having a cap body and a cap collar. In some embodiments, the cap is threadedly coupled to the housing such that rotation of the cap about the longitudinal axis in a first direction urges the cap distally relative to the housing and rotation of the cap in a second direction urges the cap proximally relative to the housing. In some embodiments, the housing collar prevents distal movement of the cap collar relative to the housing collar. In some embodiments, the cap collar is separated from the cap body and retained on the housing when the cap is rotated in the first direction.
[0017] In some embodiments, the injector further includes a medicament container disposed within the housing and containing a volume of a medicament, a needle coupled to a distal end of the medicament container and in fluid communication therewith, and a needle guard at least partially disposed within the distal end of the housing and moveable relative to the housing along the longitudinal axis.
[0018] In some embodiments, the cap includes an engagement thread extending inward from the cap body, the engagement thread configured to engage the needle guard to prevent proximal movement of the needle guard when the cap is coupled to the housing. In some embodiments, the cap includes a needle shield receiver defined on a distal end thereof, the needle shield receiver configured to couple the cap to a needle shield removably coupled to the needle when the cap is coupled to the housing, and wherein removal of the cap from the housing removes the needle shield from the needle. [0019] In another embodiment, there is an injector including a housing having a proximal end, a distal end, and a longitudinal axis extending between the proximal end and the distal end, a medicament container disposed within the housing and containing a volume of a medicament, a needle coupled to a distal end of the medicament container and in fluid communication therewith, a needle guard at least partially disposed within the distal end of the housing and moveable relative to the housing along the longitudinal axis from an extended position where the needle guard extends distally from the housing to cover the needle, to a retracted position where the needle guard is moved proximally to at least partially expose the needle, to a lockout position where the needle guard extends distally from the housing to cover the needle, a trigger disposed within the housing and coupled to the needle guard, the trigger including a trigger ring configured to prevent radial deformation of the trigger, a latch disposed within the housing, the latch configured to engage the trigger, a ram movable relative to the latch, and an energy source configured to urge the ram distally relative to the latch along the longitudinal axis
[0020] In some embodiments, the trigger is engageable with the ram such that movement of the needle guard from the retracted position to the lockout position is dependent upon the position of the ram relative to the latch.
BRIEF DESCRIPTION OF THE DRAWINGS
[0021] The following detailed description of embodiments of the autoinjector, will be better understood when read in conjunction with the appended drawings of exemplary embodiments. It should be understood, however, that the invention is not limited to the precise arrangements and instrumentalities shown.
[0022] In the drawings:
[0023] Fig. 1 is a perspective view of an autoinjector in accordance with a first exemplary embodiment of the present disclosure;
[0024] Fig. 2 is a perspective view of the autoinjector of Fig. 1 with the cap removed;
[0025] Fig. 3 is a side cross-sectional view of the autoinjector of Fig. 1 with the front housing separated from the rear housing;
[0026] Figs. 4A-4B is a side cross-sectional view of the autoinjector of Fig. 1 with the coupling of the front housing and the rear housing magnified;
[0027] Fig. 5 is a perspective view of the medicament container having a staked needle of the autoinjector of Fig. 1;
[0028] Fig. 6 is a perspective view of the needle guard of the autoinjector of Fig. 1 ;
[0029] Fig. 7 is a perspective view of the trigger of the autoinjector of Fig. 1;
[0030] Fig. 8 is a perspective view of the latch of the autoinjector of Fig. 1; [0031] Fig. 9 is a perspective view of the ram of the autoinjector of Fig. 1;
[0032] Fig. 10A is a side cross-sectional view of the rear housing of the autoinjector of Fig. 1 shown in the initial state;
[0033] Fig. 10B is a side cross-sectional view of the front housing of the autoinjector of Fig. 1 shown in the initial state;
[0034] Fig. 11A is a side cross-sectional view of the rear housing of the autoinjector of Fig. 1 shown in the pre-firing state;
[0035] Fig. 1 IB is a side cross-sectional view of the front housing of the autoinjector of Fig. 1 shown in the pre-firing state;
[0036] Fig. 12A is a side cross-sectional view of the rear housing of the autoinjector of Fig. 1 shown in the triggering state;
[0037] Fig. 12B is a side cross-sectional view of the front housing of the autoinjector of Fig. 1 shown in the triggering state;
[0038] Fig. 13A is a side cross-sectional view of the rear housing of the autoinjector of Fig. 1 shown during a delivery;
[0039] Fig. 13B is a side cross-sectional view of the front housing of the autoinjector of Fig. 1 shown during a delivery;
[0040] Fig. 14A is a side cross-sectional view of the rear housing of the autoinjector of Fig. 1 shown during a delivery;
[0041] Fig. 14B is a side cross-sectional view of the front housing of the autoinjector of Fig. 1 shown during a delivery;
[0042] Fig. 15A is a side cross-sectional view of the rear housing of the autoinjector of Fig. 1 shown in the lockout state;
[0043] Fig. 15B is a side cross-sectional view of the front housing of the autoinjector of Fig. 1 shown in the lockout state;
[0044] Fig. 16 is a side view of the cap shown partially transparent for illustration purposes coupled to the housing of the autoinjector of Fig. 1 and shown in the initial state;
[0045] Fig. 17 is a side cross-sectional view of the cap coupled to the housing of the autoinjector of Fig. 1 and shown in the initial state;
[0046] Fig. 18 is a side view of the second exemplary embodiment of the front housing of an autoinjector in accordance with the present disclosure;
[0047] Fig. 19 is a perspective view of the second exemplary embodiment of the trigger of an autoinjector in accordance with the present disclosure; [0048] Fig. 20A is a perspective view of the third exemplary embodiment of the trigger of the autoinjector in accordance with the present disclosure;
[0049] Fig. 20B is a perspective view of the trigger of Fig. 20A with a transparent trigger body to illustrate the trigger band disposed therein;
[0050] Fig. 20C is a cross-sectional perspective view of the trigger of Fig. 20A;
[0051] Fig. 21 is a side view of a portion of the second embodiment of the rear housing of an autoinjector in accordance with the present disclosure;
[0052] Fig. 22 is a side view of a portion of the third embodiment of the rear housing of an autoinjector in accordance with the present disclosure;
[0053] Fig. 23 is a side view of a portion of the fourth embodiment of the rear housing of an autoinjector in accordance with the present disclosure;
[0054] Fig. 24 is a side view of a portion of the fifth embodiment of the rear housing of an autoinjector in accordance with the present disclosure;
[0055] Fig. 25 is a side view of a portion of the sixth embodiment of the rear housing of an autoinjector in accordance with the present disclosure;
[0056] Fig. 26 is a side view of a portion of the seventh embodiment of the rear housing of an autoinjector in accordance with the present disclosure;
[0057] Fig. 27 is a side view of a portion of the eighth embodiment of the rear housing of an autoinjector in accordance with the present disclosure;
[0058] Fig. 28 is a side view of a portion of the ninth embodiment of the rear housing of an autoinjector in accordance with the present disclosure; and
[0059] Fig. 29 is a side view of a portion of the tenth embodiment of the rear housing of an autoinjector in accordance with the present disclosure.
DETAILED DESCRIPTION
[0060] The present disclosure generally relates to autoinjectors, needle guard and/or button actuated triggering devices that are used in the delivery of large volumes (e g., 10 ml or larger doses) of injectable fluid, such as medicament, for sub skin surface penetration (e.g., subcutaneous and intramuscular injections). Devices that deliver large volumes of medicament are often prone to configuration restrictions as the delivery volume of the medicament increases, such as spring force limitations and syringe container breakage. Due to the current configurations of overall device design, and the limitations of the biological uptake factors that limit injection speed and volume, injection devices are often held by the user during injection for long durations and can result in other delivery methods being used such as on-body delivery systems which are attached to the patient during delivery.
[0061] Increasingly, biologies are allowing for at-home administration by patients. However, for many biologies, large doses and the resulting large volume of medicament that must be delivered often precludes self-administration because of the length of time required to hold the delivery device in place during injection. Protein hyper-concentration may be used to reduce injection volume in certain instances, but the resulting medicament often has a much higher viscosity than the traditional biologies. High-powered injectors may allow delivery of these hyper-concentrated proteins. However, typical handheld injector designs only allow for up to 2.5 mb of a viscous medicament to be injected within 30 seconds.
[0062] With the development of enzymes which locally degrade hyaluronan (HA) in the subcutaneous (SC) space, thereby temporarily removing a barrier to fluid flow, the traditional limitations of biological uptake factors that limit injection speed and volume may be reduced. As such, higher volumes of viscous medicaments may be delivered. Accordingly, there is a need to provide a handheld device capable of delivering a large dose (e.g., 3 m , 5 mb, 10 mL, 20 mb and up to 50 mL) of a viscous medicament in a delivery time appropriate for a handheld device.
[0063] Further, the use of staked needles can offer advantages over traditional luer needles, particularly in terms of supply chain resilience, as the integrated design reduces the need for additional components and connectors, potentially mitigating delays in procurement and assembly. A staked needle refers to a needle permanently attached or affixed to a medicament container or syringe during manufacturing, forming a single, integral unit, that is, a needle pre-attached to the medicament container that is not intended to be removed. Additionally, the one-piece construction of staked needles can enhance sterility by minimizing potential points of contamination, making them advantageous for self-administration.
[0064] The delivery of large dose injections poses challenges due to factors like bulging and leak back. The delivery of large dose injections becomes challenging as the expansion of soft tissues, or bulging, may occur, leading to discomfort and potential tissue damage at the injection site. Further, the issue of leak back arises, jeopardizing the accuracy of dosing and the overall efficacy of the administered medication as the fluid may escape from the injection site. To overcome such issues, drug delivery technology of large doses of a viscous medicament often utilizes the proprietary recombinant human hyaluronidase PH20 enzyme (e.g., rHuPH20; Halozyme , Inc.) that facilitates SC delivery of co-administered therapeutics. rHuPH20 works by degrading the HA, which plays a role in resistance to bulk fluid flow in the SC space, limiting large volume SC drug delivery, dispersion, and absorption. Co-administration of rHuPH20 with injectable therapies can overcome administration time and volume barriers associated with existing SC therapeutic formulations, and has been shown to reduce the burden on patients and healthcare providers compared with intravenous formulations. rHuPH20 has countless applications in the current field of injectable therapies by increasing the dispersion and absorption of other injected drugs, such as anticancer therapies (e.g., trastuzumab and rituximab), immunodeficiency treatment, in subcutaneous urography for improving resorption of radiopaque agents, and fluid delivery for rehydration.
[0065] Referring to the drawings in detail, wherein like reference numerals indicate like elements throughout, there is shown in Figs. 1-29 an autoinjector, generally designated 10, in accordance with an exemplary embodiment of the present invention.
[0066] Referring to Figs. 1-4, the injector 10 may include a housing 100, a medicament container 102, a needle 104, a needle guard 106, a trigger 108, a latch 110, a ram 112 and an energy source 114. In some embodiments, the injector 10 includes a cap 120 removably coupled to the housing 100. The cap 120 may cover the needle 104 to provide sharps protection and may couple to the needle guard 106 to prevent premature or accidental triggering of the injector 10. The housing 100 may have a proximal end and a distal end extending along a longitudinal axis AL. The housing 100 may be configured for allowing a user to grip or handle the injector 10. The housing 100 may be shaped to fit into a user’s hand for single-handed function. The housing 100 may have a generally circular cross section. In some embodiments, the housing 100 has an oval cross-section to help position the injector 10 in the user’s hand. The housing 100 may substantially house the components shown in Figs. 3-17. [0067] Referring to Figs. 1-4, the housing 100 may comprise a front housing 116 and a rear housing 118. For assembly purposes, the front housing 1 16 and rear housing 118 may be coupled together by snap-fit coupling. In some embodiments, the front housing 116 and rear housing 118 are coupled using an adhesive or other suitable means to prevent separation during use of the injector 10. In some embodiments, the front housing 116 and rear housing 118 are integrally formed together during manufacturing or assembly of the injector 10. The housing 100 may be formed from a plastic with sufficient rigidity to prevent outside forces from interfering with the interactions of the internal components of the injector 10.
[0068] When coupled to one another, the front housing 116 and the rear housing 118 may be fixed relative to each other. Referring to Figs. 3-4, the front housing 116 may include a front engagement component 124 defined thereon. The front engagement component 124 may extend radially outward from the front housing 116. In some embodiments, the front engagement component 124 may extend radially inward from the front housing 116. The rear housing 118 may include a rear engagement component 126 defined thereon. The rear engagement component 126 may be an aperture extending through the rear housing 118. The rear engagement component 126 may be shaped and sized to receive the front engagement component 124 when the front housing 116 and the rear housing 118 are coupled together. Engagement of the front engagement component 124 and the rear engagement component 126 may prevent the front housing 116 from moving relative to the rear housing 118. In some embodiments, the rear engagement component 126 extends radially inward or radially outward from the rear housing 118. In some embodiments, the front engagement component 124 is an aperture extending through the front housing 116.
[0069] A user of the injector 10 may need to observe the volume of the medicament within the medicament container 102 before or during an injection. Referring to Figs. 1-2, the front housing 116 may include a window 122 defined therein. The window 122 may be a generally ovular aperture extending through the front housing 116. In some embodiments, the window 122 is circular or rectangular. The window 122 may include a transparent film extending across the aperture defining the window 122. The film may be a transparent plastic or glass. In some embodiments, the window 122 does not include a film.
[0070] The front housing 116 may be configured to house the medicament container 102, the needle 104 and the needle guard 106. The medicament container 102 may be at least partially disposed within the housing 100. The medicament container 102 may be fixed relative to the housing 100. The medicament container 102 may contain a volume of a medicament. As used herein, the medicament may comprise drugs, biologies, solutions, gels, suspensions or other substances that may be delivered via a syringe or needle, and such terms may be used interchangeably as appearing in the specification and claims. The medicament container 102 may be a prefilled syringe. In some embodiments, the medicament container 102 may be an insertable medicament cartridge. In some embodiments, the medicament container 102 may be filled using a vial-and-needle or other appropriate filling method. In one embodiment, the medicament container 102 is one of a prefilled cartridge, prefilled staked needle syringe, vial, or other injectable fluid containing vessel. The medicament container 102 has a distal portion and a proximal portion opposite the distal portion.
[0071] Referring to Figs. 3-4, the medicament container 102 may comprise a container portion 128 defining a fluid chamber containing the medicament. The container portion 128 may be open on a first end and may be tapered on a second end. The first end may include a container lip 134 extending radially therefrom. The container lip 134 may be configured to engage the housing 100 to prevent distal movement of the medicament container 102 relative to the housing 100. The second end may include the needle 104, as described in more detail below. In one embodiment, the container portion 128 of the medicament container 102 has a maximum volume of approximately 10 mL. In one embodiment, the container portion 128 of the medicament container 102 has a maximum volume selected from approximately: a) 3 mL, 3.5 mL, 4 mL, 4.5 mL, 5.5 mL, 6 mL, 6.5 mL, 7 mL, 7.5 mL, 8 mL, 8.5 mL,
9 mL, 9.5 mL, 10 mL, 10.5 mL, 11 mL, 11.5 mL, 12 mL, 12.5 mL, 13 mL, 13.5 mL, 14 mL, 14.5 mL, 15 mL, 15.5 mL, 16 mL, 16.5 mL, 17 mL, 17.5 mL, 18 mL, 18.5 mL, 19 mL, 19.5 mL, 20 mL. 25 mL, 30 mL, 35 mL, 40 mL, 45 mL, and 50 mL; b) 3 mL to 5 mL, 3 mL to 10 mL, 3 mL to 15 mL, 3 mL to 20 mL, 3 mL to 25 mL, 3 ml to 30 mL, 3 mL to 35 mL, 3 mL to 40 mL, 3 mL to 45 mL, 3 mL to 50 mL, 5 mL to 10 mL,
5 mL to 15 mL, 5 mL to 20 mL, 5 mL to 25 mL, 5 mL to 30 mL, 5 mL to 35 mL, 5 mL to 40 mL, 5 mL to 45 mL, 5 mL to 50 mL, 10 mL to 15 mL, 10 mL to 20 mL, 10 mL to 25 mL, 10 mL to 30 mL, 10 mL to 35 mL, 10 mL to 40 mL, 10 mL to 50 mL; c) about 3 mL to about 5 mL, about 3 mL to about 10 mL, about 3 mL to about 15 mL, about 3 mL to about 20 mL, about 3 mL to about 25 mL, about 3 ml to about 30 mL, about 3 mL to about 35 mL, about 3 mL to about 40 mL, about 3 mL to about 45 mL, about 3 mL to about 50 mL, about 5 mL to about 10 mL, about 5 mL to about 15 mL, about 5 mL to about 20 mL, about 5 mL to about 25 mL, about 5 mL to about 30 mL, about 5 mL to about 35 mL, about 5 mL to about 40 mL, about 5 mL to about 45 mL, about 5 mL to about 50 mL, about
10 mL to about 15 mL, about 10 mL to about 20 mL, about 10 mL to about 25 mL, about 10 mL to about 30 mL, about 10 mL to about 35 mL, about 10 mL to about 40 mL, about 10 mL to about 50 mL; d) at least about 3 mL, at least about 3.5 mL, at least about 4 mL, at least about 4.5 mL, at least about 5.5 mL, at least about 6 mL, at least about 6.5 mL, at least about 7 mL, at least about 7.5 mL, at least about 8 mL, at least about 8.5 mL, at least about 9 mL, at least about 9.5 mL, at least about 10 mL, at least about 10.5 mL, at least about 11 mL, at least about 11.5 mL, at least about 12 mL, at least about 12.5 mL, at least about 13 mL, at least about 13.5 mL, at least about 14 mL, at least about 14.5 mL, at least about 15 mL, at least about 15.5 mL, at least about 16 mL, at least about 16.5 mL, at least about 17 mL, at least about 17.5 mL, at least about 18 mL, at least about 18.5 mL, at least about 19 mL, at least about 19.5 mL, at least about 20 mL, at least about 25 mL, at least about 30 mL, at least about 35 mL, at least about 40 mL, at least about 45 mL, at least about 50 mL; and e) at least 3 mL, at least 3.5 mL, at least 4 mL, at least 4.5 mL, at least 5.5 mL, at least
6 mL, at least 6.5 mL, at least 7 mL, at least 7.5 mL, at least 8 mL, at least 8.5 mL, at least 9 mL, at least 9.5 mL, at least 10 mL, at least 10.5 mL, at least 11 mL, at least 11.5 mL, at least 12 mL, at least 12.5 mL, at least 13 mL, at least 13.5 mL, at least 14 mL, at least 14.5 mL, at least 15 mL, at least 15.5 mL, at least 16 mL, at least 16.5 mL, at least 17 mL, at least 17.5 mL, at least 18 mL, at least 18.5 mL, at least 19 mL, at least 19.5 mL, at least 20 mL, at least
25 mL, at least 30 mL, at least 35 mL, at least 40 mL, at least 45 mL, at least 50 mL.
[0072] Referring to Figs. 3-4, the medicament container 102 may further comprise a plunger 130 movable within the container portion 128 relative to the medicament container 102. Prior to use or triggering of the injector 10, the plunger 130 may be disposed within the container portion 128 proximate the distal portion of the medicament container 102. The plunger 130 may seal the medicament in the container portion 128. The plunger 130 may be generally cylindrical and made of a rubber material. In one embodiment, the plunger 130 is made of aplastic, butyl rubber, polyisoprene, polytetrafluorethylene, high density polyethylene or other thermoset elastomers.
[0073] In one embodiment, referring to Figs. 3-4, the needle 104 is in fluid communication with the medicament in the container portion 128. The needle 104 may be integrally formed in the distal portion of the medicament container 102. In some embodiments, the medicament container 102 includes a needle support 132 extending from the distal portion thereof. The needle support 132 may be a generally cylindrical member configured to couple the needle 104 to the medicament container
102 and prevent movement of the needle 104 relative to the medicament container 102. The needle
104 may be a 25 gauge needle. The needle 104 may correspond to a size selected from: a) 15 gauge, 16 gauge, 17 gauge, 18 gauge, 19 gauge, 20 gauge, 21 gauge, 22 gauge,
23 gauge, 24 gauge, 25 gauge, 26 gauge, 27 gauge, 28 gauge, 29 gauge, 30 gauge, 31 gauge, 32 gauge, 33 gauge, 34 gauge, or 35 gauge; b) 15 gauge to 17 gauge, 15 gauge to 20 gauge, 15 gauge to 22 gauge, 15 gauge to 25 gauge, 15 gauge to 27 gauge, 15 gauge to 30 gauge, 15 gauge to 32 gauge, 15 gauge to 35 gauge, 20 gauge to 22 gauge, 20 gauge to 25 gauge, 20 gauge to 27 gauge, 20 gauge to 30 gauge, 20 gauge to 32 gauge, 20 gauge to 35 gauge, 25 gauge to 27 gauge, 25 gauge to 30 gauge, 25 gauge to 32 gauge, 25 gauge to 35 gauge, 30 gauge to 32 gauge, or 30 gauge to 35 gauge; and c) at least 15 gauge, at least 16 gauge, at least 17 gauge, at least 18 gauge, at least 19 gauge, at least 20 gauge, at least 21 gauge, at least 22 gauge, at least 23 gauge, at least 24 gauge, at least 25 gauge, at least 26 gauge, at least 27 gauge, at least 28 gauge, at least 29 gauge, at least 30 gauge, at least 31 gauge, at least 32 gauge, at least 33 gauge, at least 34 gauge, or at least 35 gauge. [0074] The injector 10 may be configured to deliver the entire amount or a portion of the medicament within medicament container 102. The medicament contained in the medicament container 102 may have a volume of approximately 10 mb. In one embodiment, the medicament contained in the medicament container 102 corresponds to a volume selected from: a) 3 mL to 5 mL, 3 mL to 10 mL, 3 mL to 15 mL, 3 mL to 20 mL, 3 mL to 25 mL, 3 ml to 30 mL, 3 mL to 35 mL, 3 mL to 40 mL, 3 mL to 45 mL, 3 mL to 50 mL, 5 mL to 10 mL,
5 mL to 15 mL, 5 mL to 20 mL, 5 mL to 25 mL, 5 mL to 30 mL, 5 mL to 35 mL, 5 mL to 40 mL, 5 mL to 45 mL, 5 mL to 50 mL, 10 mL to 15 mL, 10 mL to 20 mL, 10 mL to 25 mL, 10 mL to 30 mL, 10 mL to 35 mL, 10 mL to 40 mL, 10 mL to 50 mL; b) about 3 mL to about 5 mL, about 3 mL to about 10 mL, about 3 mL to about 15 mL, about 3 mL to about 20 mL, about 3 mL to about 25 mL, about 3 ml to about 30 mL, about 3 mL to about 35 mL, about 3 mL to about 40 mL, about 3 mL to about 45 mL, about 3 mL to about 50 mL, about 5 mL to about 10 mL, about 5 mL to about 15 mL, about 5 mL to about 20 mL, about 5 mL to about 25 mL, about 5 mL to about 30 mL, about 5 mL to about 35 mL, about 5 mL to about 40 mL, about 5 mL to about 45 mL, about 5 mL to about 50 mL, about 10 mL to about 15 mL, about 10 mL to about 20 mL, about 10 mL to about 25 mL, about 10 mL to about 30 mL, about 10 mL to about 35 mL, about 10 mL to about 40 mL, about 10 mL to about 50 mL; c) at least about 3 mL, at least about 3.5 mL, at least about 4 mL, at least about 4.5 mL, at least about 5.5 mL, at least about 6 mL, at least about 6.5 mL, at least about 7 mL, at least about 7.5 mL, at least about 8 mL, at least about 8.5 mL, at least about 9 mL, at least about 9.5 mL, at least about 10 mL, at least about 10.5 mL, at least about 1 1 mL, at least about 11 .5 mL, at least about 12 mL, at least about 12.5 mL, at least about 13 mL, at least about 13.5 mL, at least about 14 mL, at least about 14.5 mL, at least about 15 mL, at least about 15.5 mL, at least about 16 mL, at least about 16.5 mL, at least about 17 mL, at least about 17.5 mL, at least about 18 mL, at least about 18.5 mL, at least about 19 mL, at least about 19.5 mL, at least about 20 mL, at least about 25 mL, at least about 30 mL, at least about 35 mL, at least about 40 mL, at least about 45 mL, at least about 50 mL; and d) at least 3 mL, at least 3.5 mL, at least 4 mL, at least 4.5 mL, at least 5.5 mL, at least
6 mL, at least 6.5 mL, at least 7 mL, at least 7.5 mL, at least 8 mL, at least 8.5 mL, at least 9 mL, at least 9.5 mL, at least 10 mL, at least 10.5 mL, at least 11 mL, at least 11.5 mL, at least 12 mL, at least 12.5 mL, at least 13 mL, at least 13.5 mL, at least 14 mL, at least 14.5 mL, at least 15 mL, at least 15.5 mL, at least 16 mL, at least 16.5 mL, at least 17 mL, at least 17.5 mL, at least 18 mL, at least 18.5 mL, at least 19 mL, at least 19.5 mL, at least 20 mL, at least 25 mL, at least 30 mL, at least 35 mL, at least 40 mL, at least 45 mL, at least 50 mL.
[0075] Flow rate of the injector 10 is heavily dependent on the viscosity and volume of the medicament. However, the injector 10 may deliver the full volume of the medicament at a rate of approximately 0.33 mL/sec. The injector 10 may deliver 10 mL of the medicament at a rate of 0.33 mL/sec. In one embodiment, the injector 10 delivers the full deliverable volume of the medicament at a rate of: a) 0.5 mL/10 sec., 0.75 mL/10 sec., 1 mL/10 sec., 1.25 mL/10 sec., 1.5 mL/10 sec., 1.75 mL/10 sec, 2 mL/10 sec., 2.25 mL/10 sec, 2.5 mL/10 sec., 2.75 mL/10 sec, 3 mL/10 sec., 3.25 mL/10 sec, 3.5 mL/10 sec., 3.75 mL/10 sec, 4 mL/10 sec., 4.25 mL/10 sec, 4.5 mL/10 sec., 4.75 mL/10 sec, 5 mL/10 sec; b) at least 0.5 mL/10 sec., at least 0.75 mL/10 sec., at least 1 mL/10 sec., at least 1.25 mL/10 sec., at least 1.5 mL/10 sec., at least 1.75 mL/10 sec, at least 2 mL/10 sec., at least 2.25 mL/10 sec, at least 2.5 mL/10 sec., at least 2.75 mL/10 sec, at least 3 mL/10 sec., at least 3.25 mL/10 sec, at least 3.5 mL/10 sec., at least 3.75 mL/10 sec, at least 4 mL/10 sec., at least 4.25 mL/10 sec, at least 4.5 mL/10 sec., at least 4.75 mL/10 sec, at least 5 mL/10 sec; c) 2 mL/30 sec., 2.5 mL/30 sec., 3 mL/30 sec., 3.5 mL/30 sec., 4 mL/30 sec., 4.5 mL/30 sec., 5 mL/30 sec., 5.5 mL/30 sec., 6 mL/30 sec., 6.5 mL/30 sec., 7 mL/30 sec., 7.5 mL/30 sec., 8 mL/30 sec., 8.5 mL/30 sec., 9 mL/30 sec., 9.5 mL/30 sec., 10 mL/30 sec., 10.5 mL/30 sec.; and d) 4 mL/min., 5 mL/min., 6 mL/min., 7 mL/min., 8 mL/min., 9 mL/min., 10 mL/min., 11 mL/min., 12 mL/min., 13 mL/min., 14 mL/min., 15 mL/min., 16 mL/min., 17 mL/min., 18 mL/min., 19 mL/min., 20 mL/min., 21 mL/min.
[0076] The viscosity of the medicament may be between 1-20 cP. In one embodiment, the medicament may have a viscosity of: a) 1 cP, 2 cP, 3 cP, 4 cP, 5 cP, 6 cP, 7 cP, 8 cP, 9 cP, 10 cP, 11 cP, 12 cP, 13 cP, 14 cP,
15 cP, 16 cP, 17 cP, 18 cP, 19 cP, 20 cP; and b) between 1-20 cP, between 2-19 cP, between 3-18 cP, between 4-17 cP, between 5-
16 cP, between 6-15 cP, between 7-14 cP, between 8-13 cP, between 9-12 cP, between 10-11 cP. [0077] In some embodiments, the user’s experience is improved if the injector 10 delivers the full volume of the medicament as fast as possible. A faster delivery may result in less pain and discomfort for the patient. The injector 10 may deliver the full deliverable volume of the medicament in less than
5 seconds. In some embodiments, the injector 10 may deliver the full deliverable volume of the medicament in less than 10 seconds, less than 15 seconds, less than 20 seconds, less than 25 seconds, less than 30 seconds, less than 35 seconds, less than 40 seconds, less than 45 seconds, less than 50 seconds, less than 55 seconds, less than 60 seconds, less than 70 seconds, less than 80 seconds, less than 90 seconds, less than 100 seconds, less than 110 seconds, or less than 120 seconds. In some embodiments, the injector 10 may deliver the full volume of the medicament in between 5-120 seconds, between 10-110 seconds, between 15-100 seconds, between 20-90 seconds, between 25-80 seconds, between 30-70 seconds, between 35-60 seconds, between 40-55 seconds, or between 45-50 seconds.
[0078] Needle guards (e.g., needle guard 106) play a crucial role in ensuring safety by minimizing the risk of accidental needlestick injuries and the potential transmission of bloodborne infections, thus promoting a safer experience. Referring to Figs. 2-4 and 6, the needle guard 106 may be at least partially disposed within the distal end of the housing 100. The needle guard 106 may be a generally cylindrical member with a guard aperture 136 extending through a distal end and at least one guard arm 138 extending from a proximal end. The guard aperture 136 may be a generally circular aperture shaped and sized to allow the needle 104 to pass therethrough during use of the injector 10. The distal end of the needle guard 106 may be generally rounded or tapered around the guard aperture 136. The needle guard 106 may include a cap engagement feature 140 extending radially therefrom. The cap engagement feature 140 may be a generally rounded member located proximate the distal end of the needle guard 106. In some embodiments, the needle guard 106 includes two or more cap engagement features 140 spaced apart from each other proximate the distal end of the needle guard 106. As described in more detail below, the cap engagement feature 140 may interact with the cap 120 to removably couple the cap 120 to the needle guard 106.
[0079] Referring to Fig. 6, the guard arm 138 may extend proximally from the needle guard 106. The guard arm 138 may have a curvature substantially similar to that of the needle guard 106 so as to act as a proximal extension of the needle guard 106. In some embodiments, the needle guard 106 includes two guard arms 138 spaced apart from each other. The space between the two guard arms may define a notch 142. The notch 142 may be shaped and sized to avoid interference with the window 122 of the housing 100 during use of the injector 10. The notch 142 may have a rounded distal portion and an open proximal portion.
[0080] To reduce rotation of the needle guard 106 relative to the housing 100 during use of the injector 10, the guard arm 138 may include a guard guide 144 defined thereon. The guard guide 144 may extend radially from the guard arm 138. The guard guide 144 may extend relative to the longitudinal axis AL along a length of the guard arm 138. The guard guide 144 may extend along at least a portion of the length of the guard arm 138. In some embodiments, the guard guide 144 extends along the entire length of the guard arm 138. The guard guide 144 may be configured to engage a feature defined on an inner surface of the front housing 116 to prevent rotation of the needle guard 106 relative to the housing 100. In some embodiments, the guard arm 138 includes two guard guides 144 spaced apart from each other.
[0081] During assembly of the injector 10, the needle guard 106 and the trigger 108 are configured to couple relative to each other. Referring to Fig. 6, the needle guard 106 may include a trigger engagement feature 146 defined thereon. The trigger engagement feature 146 may extend radially from the guard arm 138 proximate the proximal end thereof. The trigger engagement feature 146 may be a generally rectangular member and may be spaced apart from the guard guide 144 so as to allow a portion of the trigger 108 to be received therebetween. Engagement of the trigger 108 and the trigger engagement feature 146 may prevent movement of the needle guard 106 relative to the trigger 108. [0082] Referring to Figs. 10A-15B, and as described in more detail below, the needle guard 106 may be moveable relative to the housing 100 along the longitudinal axis AL from an extended position (Fig. 1 IB) where the needle guard 106 extends distally from the housing 100 to cover the needle 104, to a retracted position (Fig. 12B) where the needle guard 106 is moved proximally relative to the housing 100 to at least partially expose the needle 104, to a lockout position (Fig. 15B) where the needle guard 106 extends distally from the housing 100 to cover the needle 104.
[0083] A distal end of the needle guard 106 may extend a first distance from the housing 100 in the extended position. The distal end of the needle guard 106 may extend a second distance from the housing 100 in the lockout position. The second distance may be greater than the first distance. The first distance may be at least 20 mm. The distal end of the needle guard 106 may be at least 4.5 mm from a distal end of the needle 104 in the extended position. The distal end of the needle guard 106 may be at least about 5 mm to about 25 mm from the distal end of the needle 104 in the extended position. In some embodiments, the distal end of the needle guard 106 is at least about 5 mm, at least about 6 mm, at least about 7 mm, at least about 8 mm, at least about 9 mm, at least about 10 mm, at least about 11 mm, at least about 12 mm, at least about 13 mm, at least about 14 mm, at least about 15 mm, at least about 16 mm, at least about 17 mm, at least about 18 mm, at least about 19 mm, at least about 20 mm, at least about 21 mm, at least about 22 mm, at least about 23 mm, at least about 24 mm or at least about 25 mm from the distal end of the needle 104 in the extended position. In some embodiments, the distal end of the needle guard 106 is between about 5 mm and about 25 mm, between about 6 mm and about 24 mm, between about 7 mm and about 23 mm, between about 8 mm and about 22 mm, between about 9 mm and about 21 mm, between about 10 mm and about 20 mm, between about 11 mm and about 19 mm, between about 12 mm and about 18 mm, between about 13 mm and about 17 mm or between about 14 mm and about 16 mm from the distal end of the needle 104 in the extended position.
[0084] The second distance may be at least 25 mm. The second distance may be at least 2 mm greater than the first distance. In some embodiments, the second distance is less than 2 mm greater than the first distance. The distal end of the needle guard 106 may be at least 6.5 mm from the distal end of the needle 104 in the lockout position. The distal end of the needle guard 106 may be at least about 7 mm to about 27 mm from the distal end of the needle 104 in the lockout position. In some embodiments, the distal end of the needle guard 106 is at least about 7 mm, at least about 8 mm, at least about 9 mm, at least about 10 mm, at least about 11 mm, at least about 12 mm, at least about 13 mm, at least about 14 mm, at least about 15 mm, at least about 16 mm, at least about 17 mm, at least about 18 mm, at least about 19 mm, at least about 20 mm, at least about 21 mm, at least about 22 mm, at least about 23 mm, at least about 24 mm, at least about 25 mm, at least about 26 mm or at least about 27 mm from the distal end of the needle 104 in the lockout position. In some embodiments, the distal end of the needle guard 106 is between about 7 mm and about 27 mm, between about 8 mm and about 26 mm, between about 9 mm and about 25 mm, between about 10 mm and about 24 mm, between about 11 mm and about 23 mm, between about 12 mm and about 22 mm, between about 13 mm and about 21 mm, between about 14 mm and about 20 mm, between about 15 mm and about 19 mm or between about 16 mm and about 18 mm from the distal end of the needle 104 in the extended position.
[0085] The inclusion of the cap 120 coupled to the housing 100 may assist with preventing premature movement of the needle guard 106. The cap 120 may ensure the controlled and safe deployment of the needle 104 during use of the injector 10, thereby minimizing the risk of accidental injuries. Referring to Figs. 16-17, the cap 120 may include a cap body 148 and a cap collar 150.
[0086] The cap body 148 may be a generally cylindrical member with an open proximal end and a closed distal end. The cap body 148 may have a plurality of ribs 152 defined on an exterior surface thereof. The ribs 152 may extend around at least a portion of the circumference of the cap body 148. In some embodiments, the ribs 152 extend around the entire circumference of the cap body 148. The ribs 152 may extend relative to the longitudinal axis AL along a length of the cap body 148. The ribs 152 may extend along at least a portion of the length of the cap body 148. In some embodiments, the ribs 152 extend along the entire length of the cap body 148.
[0087] The cap collar 150 may provide a visual indicator of whether the cap 120 has been previously removed from the housing 100. This feature may enhance patient safety by providing a clear and easily discernible means to track the integrity of the injector 10. Referring to Fig. 16, the cap collar 150 may be configured to separate from the cap body 148 when the cap 120 is decoupled from the housing 100. The cap collar 1 0 may include one or more cap collar coupling components 158 extending axially therefrom. The cap collar coupling components 158 may removably couple the cap collar 150 to the cap body 148. In some embodiments, the cap collar coupling component 158 is a generally triangular feature. A base of the cap collar coupling component 158 may be integrally formed on the cap collar 150. A point of the cap collar coupling component 158 may engage the cap body 148. The cap collar coupling components 158 may be configured to resist separation from the cap body 148 up to a threshold force. The threshold force may be between about 5 inch-lbs to 12 inch-lbs of torque. In some embodiments, the threshold force is at least about 5 inch-lbs, at least about 6 inch-lbs, at least about 7 inch-lbs, at least about 8 inch-lbs, at least about 9 inch-lbs, at least about 10 inch-lbs, at least about 11 inch-lbs or at least about 12 inch-lbs. In some embodiments, the threshold force is between about 5 inch-lbs and 12 inch-lbs, between about 6 inch-lbs and 11 inch-lbs, between about 7 inch-lbs and 10 inch-lbs or between about 8 inch-lbs and 9 inch-lbs.
[0088] The housing 100 may include a housing collar 154 defined thereon configured to receive at least a portion of the cap collar 150 therein. The housing collar 154 may prevent distal movement of the cap collar 150 relative to the housing collar 154 when the cap body 148 is removed from the housing 100. The housing collar 154 may be located proximate the distal end of the housing 100. The cap collar 150 may include one or more collar projections 156 (not shown) extending radially inward from the cap collar 150. The collar projection 156 may be shaped and sized to be disposed in the housing collar 154. When the cap collar 150 is separated from the cap body 148, the cap collar 150 may be freely rotatable relative to the housing collar 154.
[0089] The cap 120 may be removably coupled to the distal end of the housing 100. Referring to Figs. 16 and 17, the cap 120 may be threadedly coupled to the housing 100 such that rotation of the cap 120 about the longitudinal axis AL in a first direction urges the cap 120 distally relative to the housing 100 and rotation of the cap 120 in a second direction urges the cap 120 proximally relative to the housing 100. The cap 120 may include a cap thread 160 defined on an interior surface of the cap body 148. The cap thread 160 may be configured to engage a housing thread 162 defined on the front housing 116. The cap thread 160 may include two thread rails 164 spaced apart and configured to receive the housing thread 162 therebetween. The thread rail 164 may extend radially in from the interior surface of the cap body 148. In some embodiments, the cap thread 160 is defined in the cap body and extends radially out from the interior surface of the cap body 148. In some embodiments, the housing thread 162 includes thread rails 164 configured to receive the cap thread 160. The cap thread 160 and the housing thread 162 may be angled such that rotation in the first direction and second direction urge the cap distally or proximally relative to the housing 100, respectively. The cap collar 150 may separate from the cap body 148 and may be retained on the housing 100 when the cap 120 is rotated in the first direction.
[0090] The cap 120 may physically restrain the needle guard 106 from moving proximally. This can be an important feature for preventing inadvertent needle movement in certain cases, such as dropping or other abrupt stops, adding an extra layer of safety to minimize the potential for accidental firing during handling or transportation. Referring to Fig. 16, the cap 120 may include a cap engagement thread 166 extending radially inward from the interior surface of the cap body 148. The cap engagement thread 166 may engage the cap engagement feature 140 of the needle guard 106 to prevent proximal movement of the needle guard 106 when the cap 120 is coupled to the housing 100. The cap engagement thread 166 may be angled such that rotation of the cap 120 in the second direction urges the cap engagement feature 140 of the needle guard 106 distally.
[0091] The cap 120 may couple to a needle shield 168 removably coupled to the needle 104 when the cap 120 is coupled to the housing 100. Further, simultaneous removal of the needle shield 168 when the cap 120 is separated from the housing 100 is an important safety measure, ensuring a seamless and controlled process that minimizes the risk of contamination and/or accidental needle exposure.
[0092] Referring to Figs. 16-17, the cap 120 may include a cap aperture 172 defined on the distal end thereof. A needle shield receiver 170 may extend through cap aperture 172. In some embodiments, the needle shield receiver 170 is the cap aperture 172. A needle shield remover 173 may be disposed within the cap 120 and may be removably coupled to the needle shield 168 when the cap 120 is coupled to the housing 100. In some embodiments, the needle shield remover 173 is configured to flex to receive the needle shield 168 therein during assembly of the injector 10. The needle shield remover 173 may be rotatable relative to the needle shield 168 when the cap 120 is separated from the housing 100. In some embodiments, the needle shield remover 173 is fixed to the needle shield 168. The cap aperture 172 may be shaped and sized to receive at least a portion of a remover protrusion 174 of the needle shield remover 173 therethrough when the cap 120 is coupled to the housing 100. The remover protrusion 174 may have a bulb or radial protrusion defined on a distal end thereof to prevent axial movement of the needle shield remover 173 relative to the cap 120 when the remover protrusion 174 is received in the cap aperture 172. The needle shield remover 173 may be coupled to the cap 120 such that rotation of the cap 120 in the first direction and subsequent removal of the cap 120 from the housing 100 removes the needle shield 168 from the needle 104 thereby exposing the needle 104 within the needle guard 106. The needle shield remover 173 may prevent axially movement of the needle shield 168 relative thereto when the cap 120 is removed from the housing 100. The guard aperture 136 of the needle guard 106 may be sized and shaped to allow the needle shield 168 and needle shield remover 173 to pass therethrough during removal of the cap 120.
[0093] The trigger 108 may be disposed within the housing 100 and coupled to the needle guard 106. The trigger 108 may be moveable relative to the housing 100 along the longitudinal axis AL in response to movement of the needle guard 106. As described in more detail below, engagement of the trigger 108 with the latch 110 during movement of the trigger 108 may cause the injector 10 to expel the medicament. Referring to Fig. 7, the trigger 108 may be a generally cylindrical member extending along the longitudinal axis AL. The trigger 108 may have a trigger body 176 and at least one trigger arm 178 extending axially from the trigger body 176.
[0094] Referring to Fig. 7, the trigger body 176 may have a proximal end and a distal end opposite the proximal end. Both the proximal end and the distal end of the trigger body 176 may be open and sized to receive components of the rear housing 118 therein, as described in more detail below. The trigger body 176 may include at least one trigger ring 180 extending around a circumference of the trigger body 176. In some embodiments, the trigger body 176 includes a plurality of trigger rings 180. The trigger ring 180 may be located proximate the proximal end of the trigger body 176. The trigger ring 180 may provide improved rigidity of the trigger body 176 by increasing the cross-sectional thickness of the trigger body 176, thereby increasing the hoop strength of the trigger 108. The trigger ring 180 may be integrally formed on the trigger body 176. In some embodiments, the trigger ring 180 is coupled to the trigger body 176 with an adhesive or welding.
[0095] The trigger body 176 may include a trigger aperture 182 extending therethrough. The trigger aperture 182 may be shaped and sized to allow at least a portion of the latch 110 to extend therethrough. The trigger aperture 182 may be located proximate the distal end of the trigger body 176. In some embodiments, the trigger aperture 182 is located between the proximal end and the distal end, or proximate the distal end of the trigger body 176. The trigger aperture 182 may be a generally rectangular shape. In some embodiments, the trigger aperture 182 is a rounded shape. The trigger body 176 may include a latch engagement feature 184 defined thereon. The latch engagement feature 184 may be located on an interior surface of the trigger body 176 proximate the distal end thereof. As described in more detail below, the latch engagement feature 184 is shaped and sized to engage at least a portion of the latch 110 during use of the injector 10. [0096] Referring to Fig. 7, the trigger arm 178 may extend distally along the longitudinal axis AL from the trigger body 176. The trigger arm 178 may be a generally rectangular member with a curvature about the longitudinal axis AL substantially similar to that of the trigger body 176. The trigger arm 178 may include first arm member 188 and a second arm member 190 defining a trigger arm slot 186 therebetween. The trigger arm slot 186 may extend from a distal end at least partially along a length of the trigger arm 178. The trigger arm slot 186 may increase flexibility of the distal end of the trigger arm 178. The first arm member 188 and second arm member 190 may be configured to flex toward each other in response to a radial force acting thereon. In some embodiments, only one of the first arm member 188 or the second arm member 190 is configured to move toward the other.
[0097] Referring to Fig. 7, the first arm member 188 and second arm member 190 may each include a guard engagement surface 192 and a guard receiver 194 defined on the distal end thereof. The guard engagement surface 192 may be angled such that engagement of the guard engagement surface 192 with the trigger engagement feature 146 of the needle guard 106 flexes the first arm member 188 and second arm member 190 toward each other as the front housing 116 and the rear housing 118 are moved toward each other. The trigger engagement feature 146 may be received in the guard receiver 194 when the front housing 116 and the rear housing 118 are coupled together. Engagement of the guard receiver 194 and the trigger engagement feature 146 may couple the needle guard 106 and the trigger 108. The first arm member 188 and second arm member 190 may flex apart when the trigger engagement feature 146 is received in the guard receiver 194.
[0098] The latch 110 may be disposed within the housing 100 and may be fixed relative thereto. The latch 110 may be fixed proximate the proximal end of the housing 100 in the rear housing 118. As described in more detail below, the latch 110 may be configured to engage the trigger 108 as the trigger 108 moves relative to the latch 110. Referring to Fig. 8, the latch 110 may include a latch body 196 having a generally cylindrical shape extending along the longitudinal axis AL. The latch body 196 may be shaped and sized to fit within the trigger body 176. The trigger body 176 may be disposed between the latch body 196 and the rear housing 118 and may be moveable relative to the latch body 196 and the rear housing 118. The latch body 196 may include a trigger guide 204 defined thereon. The trigger guide 204 may be an elongated recess defined along at least a portion of the latch body 196. The trigger guide 204 may be configured to receive a portion of the trigger 108 to help align the movement of the trigger 108 along the longitudinal axis AL.
[0099] Referring to Fig. 8, the latch 110 may include a latch collar 198 at a proximal end thereof. The latch collar 198 may be a generally disc-shaped feature and may have a diameter larger than a diameter of the latch body 196. The latch collar 198 may be integrally formed with the latch body 196. In some embodiments, the latch collar 198 is coupled to the latch body 196 with an adhesive or welding. The latch collar 198 may include a housing engagement component 200 extending distally therefrom. At least a portion of the housing engagement component 200 may extend radially outward from the latch collar 198 and may be configured to engage the rear housing 118 to fix the latch 110 relative thereto. The rear housing 118 may include a latch receiver 202 (Fig. 1) shaped and sized to receive at least a portion of the housing engagement component 200 therein. Engagement of the latch receiver 202 and the housing engagement component 200 may prevent the latch from moving distally relative to the housing 100 during use of the injector 10. The latch 110 may include two housing engagement components 200 spaced apart on the latch collar 198. In some embodiments, the latch 110 includes at least two housing engagement components 200 spaced apart on the latch collar 198. The latch 110 may include at least one collar support 206 coupled to the latch collar 198 and the latch body 196. The collar support 206 may reduce movement of the latch body 196 relative to the latch collar 198 during use of the injector 10.
[00100] Referring to Fig. 8, the latch collar 198 may include a latch post 210 extending distally therefrom. The latch post 210 may extend from a central portion of the latch collar 198 within the latch body 196. The latch post 210 may have a length substantially similar to that of the latch body 196. In some embodiments, the latch post 210 is longer than the latch body 196. In some embodiments, the latch post 210 is longer than the latch body 196. The latch post 210 may be spaced apart from the latch body 196 on all sides. Referring to Figs. 3-4, the latch post 210 may be disposed within the energy source 114 and the ram 112. The latch post 210 may prevent radial movement of the energy source 114, thereby ensuring the force produced by the energy source 114 is exerted primarily onto the ram 1 12. The latch post 210 may be a rounded member and may be tapered such that a diameter of the latch post 210 is greatest proximate to the latch collar 198 and smallest at a distal end of the latch post 210.
[00101] Providing support to prevent movement of the medicament container 102 relative to the housing 100 is a function of the latch 110. Referring to Fig. 8, the latch 110 may include at least one container support 208 extending from a distal end of the latch body 196. The container support 208 may be a generally rectangular member and may have a curvature substantially similar to that of the latch body 196 about the longitudinal axis AL. The container support 208 may extend from the latch body 196 to engage the container lip 134 when the front housing 116 is coupled to the rear housing 118. The container support 208 may prevent the medicament container 102 from moving proximally relative to the housing 100 during use of the injector 10. The latch 110 may include two container supports 208 spaced apart on the distal end of the latch 110. In some embodiments, the latch includes more than two container supports 208 spaced apart on the distal end of the latch 110.
[00102] The latch 1 10 may prevent movement of the ram 1 12 relative to the housing 100 prior to an injection. Referring to Fig. 8, the latch 110 may include a latch aperture 214 extending through the latch body 196. The latch aperture 214 may be a generally rectangular aperture and may include a first latch member 212 defined therein. The first latch member 212 may extend proximally from a distal end of the latch aperture 214. The first latch member 212 may have a width less than a width of the latch aperture 214. The first latch member 212 may be spaced apart from both sides of the latch aperture 214. The first latch member 212 may be moveable between a first flexed position wherein the first latch member 212 is flexed radially outward relative to the latch body 196 and a first relaxed position wherein the first latch member 212 is generally flush with the latch body 196.
[00103] The first latch member 212 may include a first flexible arm 216 extending proximally along the longitudinal axis AL and a first protrusion 218 extending radially inward from the first flexible arm 216. The first flexible arm 216 may be a generally rectangular member. The first protrusion 218 may be located at a proximate end of the first flexible arm 216 and may have a generally triangular cross section with angled surfaces facing proximally and distally. At least a portion of the first protrusion 218 is configured to be received by the ram 112 to prevent movement of the ram 112 relative to the latch 110, as described in more detail below.
[00104] The latch 110 may prevent the trigger 108 from moving distally during an injection. Referring to Fig. 8, the latch 110 may include a latch notch 220 extending through the latch body 196. The latch notch 220 may be a generally rectangular notch having an open end facing away from the latch aperture 214. In some embodiments, the latch notch 220 is a rounded shape. The latch notch 220 may include a second latch member 222 extending distally from a proximal end of the latch notch 220. The second latch member 222 may have a width less than a width of the latch notch 220. The second latch member 222 may be spaced apart from both sides of the latch notch 220. The second latch member 222 may be moveable between a second flexed position wherein the second latch member 222 is flexed radially inward relative to the latch body 196 and a second relaxed position wherein the second latch member 222 is generally flush with the latch body 196.
[00105] The second latch member 222 may include a second flexible arm 224 extending distally along the longitudinal axis AL and a second protrusion 226 extending radially outward from the second flexible arm 224. The second flexible arm 224 may be a generally rectangular member. The second protrusion 226 may be located at a distal end of the second flexible arm 224 and may have a generally triangular cross section with angled surfaces facing proximally and distally. At least a portion of the second protrusion 226 is configured to be received by the trigger 108 to prevent movement of the trigger 108 relative to the housing 100, as described in more detail below.
[00106] During an injection, the ram 112 is urged by the energy source 1 14 to move the plunger 130 through the medicament container 102 to expel the medicament through the needle 104. The ram 112 may be movable relative to the latch 110 and the housing 100. Referring to Fig. 9, the ram 112 may include a ram body 228. The ram body 228 may be a generally cylindrical member extending along the longitudinal axis AL. The ram body 228 may have a proximal end and a distal end opposite the proximal end. The proximal end of the ram body 228 may be open and the distal end of the ram body 228 may be closed. The distal end of the ram body 228 may include a ram protrusion 230 extending therefrom. The ram protrusion 230 may be a generally ovular member and may engage the plunger 130 during movement of the ram 112 relative to the medicament container 102.
[00107] Referring to Fig. 9, the ram 112 may include a ram notch 232 extending through the ram body 228. The ram notch 232 may be a generally rectangular notch having an open end facing proximally. In some embodiments, the ram notch 232 is a rounded shape. The ram notch 232 may be shaped and sized to receive at least a portion of the first protrusion 218 of the latch 110 therein. The ram body 228 may include a ram aperture 234 extending therethrough. The ram aperture 234 may be a generally rectangular aperture. In some embodiments, the ram aperture 234 is rounded. The ram aperture 234 may be shaped and sized to receive at least a portion of the first protrusion therein. The ram aperture 234 receiving the first protrusion 218 may prevent movement of the ram 112 relative to the latch 110 and relative to the housing 100.
[00108] The energy source 114 may be configured to urge the ram 112 distally along the longitudinal axis AL relative to the latch 1 10. Referring to Figs. 3-4, energy source 1 14 may be disposed at least partially within the ram 112. The energy source 114 may be disposed between the ram 112 and the latch post 210. A proximal end of the energy source 114 may engage the latch collar 198 between the latch body 196 and the latch post 210. A distal end of the energy source 114 may engage a distal end of the ram 112. In an exemplary embodiment, energy source 114 includes a compression spring; however, other suitable energy sources can be used, such as an electric pump, an elastomer or compressed-gas spring, or a gas generator, or other suitable energy storage members.
[00109] The energy source 114 may be a compression spring. The energy source 114 may have a 5 mm diameter. The energy source 114 may have a 6 mm diameter. The energy source 114 may have a 7 mm diameter. The energy source 114 may have an 8 mm diameter. The energy source 114 may have a 9 mm diameter. The energy source 114 may have a 10 mm diameter. The energy source 114 may have an 11 mm diameter. The energy source 114 may have a 12 mm diameter. The energy source 114 may have a 13 mm diameter. The energy source 114 may have a 14 mm diameter. The energy source 114 may have a 15 mm diameter. The energy source 114 may have a 0.75 mm wire diameter. The energy source 114 may have a 1 mm wire diameter. The energy source 1 14 may have a 1.25 mm wire diameter. The energy source 114 may have a 1.5 mm wire diameter. The energy source 114 may have a 1.75 mm wire diameter. The energy source 114 may have a 2 mm wire diameter.
[00110] The energy source 114 may produce at least 8 lbs of force, at least 9 lbs of force, at least 10 lbs of force, at least 11 lbs of force, at least 12 lbs of force, at least 13 lbs of force, at least 14 lbs of force, at least 15 lbs of force, at least 16 lbs of force, at least 17 lbs of force, at least 18 lbs of force, at least 19 lbs of force, at least 20 lbs of force, at least 21 lbs of force, at least 22 lbs of force, at least 23 lbs of force, at least 24 lbs of force, at least 25 lbs of force, at least 26 lbs of force, at least 27 lbs of force, at least 28 lbs of force, at least 29 lbs of force, or at least 30 lbs of force. The energy source 114 may produce between 8-30 lbs of force, between 9-29 lbs of force, between 10-28 lbs of force, between 11-27 lbs of force, between 12-26 lbs of force, between 13-25 lbs of force, between 14-24 lbs of force, between 15-23 lbs of force, between 16-22 lbs of force, between 17-21 lbs of force, or between 18-20 lbs of force.
[00111] The energy source 114 may generate up to 15 lbs of force prior to a triggering event. The energy source 114 may generate up to 17.5 lbs of force prior to a triggering event. The energy source 114 may generate up to 20 lbs of force prior to a triggering event. The energy source 114 may generate up to 22.5 lbs of force prior to a triggering event. The energy source 114 may generate up to 25 lbs of force prior to a triggering event. The energy source 114 may generate up to 27.5 lbs of force prior to a triggering event. The energy source 1 14 may generate up to 30 lbs of force prior to a triggering event.
[00112] The energy source 114 may generate a residual force of 8 lbs of force after expelling the full volume of fluid from the primary container. The energy source 114 may generate a residual force of 10 lbs of force after expelling the full volume of fluid from the primary container. The energy source 114 may generate a residual force of 12 lbs of force after expelling the full volume of fluid from the primary container. The energy source 114 may generate a residual force of 14 lbs of force after expelling the full volume of fluid from the primary container. The energy source 114 may generate a residual force of 16 lbs of force after expelling the full volume of fluid from the primary container. The energy source 114 may generate a residual force of 18 lbs of force after expelling the full volume of fluid from the primary container. The energy source 114 may generate a residual force of 20 lbs of force after expelling the full volume of fluid from the primary container. [00113] The injector 10 may include a needle guard return 236 configured to bias the needle guard 106 distally relative to the housing 100. The needle guard return 236 may be a compression spring, however, other suitable energy source can be used. A proximal end of the needle guard return 236 may engage the latch collar 198 between the latch body 196 and the housing engagement component 200. A distal end of the needle guard return 236 may engage the proximal end of the trigger 108 to urge the trigger 108 and needle guard 106 distally relative to the housing 100.
[00114] Referring to Figs. 10A-10B, the injector 10, in an initial state, may include the cap 120 coupled to the housing 100. The needle guard 106 is prevented from moving proximally along the longitudinal axis AL due to the cap engagement feature 140 interacting with the cap engagement thread 166. The needle guard 106 is in a storage position when the cap 120 is coupled to the housing 100. The needle guard 106 may extend a third distance from the housing in the storage position. The needle guard 106 may extend approximately 17 mm from the housing 100 in the storage position. The third distance may be less than the first distance and the second distance. The first distance may be at least 3 mm greater than the third distance. In some embodiments, the third distance is the same as the first distance. In some embodiments, the third distance is the same as the first distance and the second distance.
[00115] The distal end of the needle guard 106 may be at least 4.5 mm from the distal end of the needle 104 in the storage position. The distal end of the needle guard 106 may be at least about 3 mm to about 23 mm from the distal end of the needle 104 in the storage position. In some embodiments, the distal end of the needle guard 106 is at least about 3 mm, at least about 4 mm, at least about 5 mm, at least about 6 mm, at least about 7 mm, at least about 8 mm, at least about 9 mm, at least about 10 mm, at least about 1 1 mm, at least about 12 mm, at least about 13 mm, at least about 14 mm, at least about 15 mm, at least about 16 mm, at least about 17 mm, at least about 18 mm, at least about 19 mm, at least about 20 mm, at least about 21 mm, at least about 22 mm or at least about 23 mm from the distal end of the needle 104 in the storage position. In some embodiments, the distal end of the needle guard 106 is between about 3 mm and about 23 mm, between about 4 mm and about 22 mm, between about 5 mm and about 21 mm, between about 6 mm and about 20 mm, between about 7 mm and about 19 mm, between about 8 mm and about 18 mm, between about 9 mm and about 17 mm, between about 10 mm and about 16 mm, between about 11 mm and about 15 mm or between about 12 mm and about 14 mm from the distal end of the needle 104 in the storage position.
[00116] In the initial state, the energy source 114 is prevented from moving the ram 112 distally relative to the latch 110 and the housing 100 due to engagement of the first latch member 212 and the ram aperture 234. The forces of the energy source 114 and the angled surface of the first protrusion 218 are prevented by the trigger body 176 from moving the first latch member from the first relaxed position to the first flexed position.
[00117] Referring to Figs. 1 1 A-l IB, the injector 10, in a pre-firing state, may have the cap 120 removed from the front housing 116. The cap collar 150 may remain disposed in the housing collar 154. The needle guard 106 may be in an extended position when the cap 120 is removed from the housing 100. The needle guard may extend the third distance in the storage position and the first distance in the extended position.
[00118] In the pre-firing state, the ram aperture 234 may receive at least a portion of the first protrusion 218 when the needle guard 106 is in the extended position. The energy source 114 is prevented from moving the ram 112 distally relative to the latch 110 and the housing 100 due to engagement of the first latch member 212 and the ram aperture 234. The forces of the energy source 114 and the angled surface of the first protrusion 218 are prevented by the trigger body 176 from moving the first latch member 212 from the first relaxed position to the first flexed position.
[00119] Referring to Figs. 12A-12B, the injector 10, in the triggering state, may have the needle guard 106 moved proximally into a retracted position. The needle guard 106 may be moved proximally into the retracted position by the user pressing the injector 10 distally toward the injection site. The needle guard 106 may extend approximately 8 mm from the front housing 116 when the needle guard 106 is in the retracted position. The needle guard 106 may extend between about 5 mm and about 10 mm from the front housing 116 when the needle guard 106 is in the retracted position. In some embodiments, the needle guard 106 may extend less than about 5 mm, less than about 6 mm, less than about 7 mm, less than about 8 mm, less than about 9 mm or less than about 10 mm from the front housing 1 16 when the needle guard 106 is in the retracted position. In some embodiments, the needle guard 106 may extend between about 5 mm and about 10 mm, between about 6 mm and about
9 mm or between about 7 mm and about 8 mm from the front housing 116 when the needle guard 106 is in the retracted position. The needle 104 may extend through the guard aperture 136 approximately
10 mm when the needle guard 106 is in the retracted position.
[00120] Proximal movement of the needle guard 106 from the extended position to the retracted position may align the trigger aperture 182 with the first latch member 212. The forces of the energy source 114 and the angled surface of the first protrusion 218 are thereby allowed to move the first latch member 212 from the first relaxed position to the first flexed position. The energy source 114 may be allowed to urge the ram 112 distally relative to the latch 110 and relative to the housing 100 when the injector is in the triggering state. The needle guard return 236 may be prevented from moving the trigger 108 and the needle guard 106 distally by the first latch member 212 in the first flexed position. In some embodiments, the needle guard 106 is moveable proximally at least 2 mm when the first protrusion 218 is in the flexed position to allow the needle 104 to reach the intended depth for delivery of the medicament.
[00121] Referring to Figs. 13A-13B, distal movement of the ram 112 may cause the ram 112 to engage the plunger 130, thereby moving the plunger 130 relative to the medicament container 102. Movement of the plunger 130 relative to the medicament container 102 may generate pressure within the container portion 128 sufficient to eject the volume of the medicament from the medicament container 102 through a needle 104 disposed thereon.
[00122] During delivery of the medicament, the ram 112 may be moved distally such that the ram notch 232 aligns with the first protrusion 218 thereby allowing at least a portion of the first protrusion 218 to extend therein. The first protrusion 218 being received in the ram notch 232 may allow the first latch member 212 to move from the first flexed position to the first relaxed position. The needle guard return 236 may be allowed to urge the trigger 108 and the needle guard 106 distally toward a lockout position when the first latch member 212 is in the first relaxed position.
[00123] The trigger 108 may be engageable with the ram 112 such that movement of the needle guard 106 from the retracted position to the lockout position is dependent upon the position of the ram 112 relative to the latch 110. The ram 112 may prevent the needle guard 106 from moving into the lockout position during delivery of the medicament. This may be useful if the needle 104 is accidentally or prematurely removed from the injection site. As the trigger 108 and needle guard 106 move distally relative to the latch 110, the latch engagement feature 184 may engage the second protrusion 226 of the second latch member 222. The second latch member 222, in the second relaxed position, may prevent the trigger 108 and needle guard 106 from moving distally into the lockout position. The forces produced by the needle guard return 236 and the angled surface of the second protrusion 226 and latch engagement feature 184 may be prevented by the ram 112 from moving the second latch member 222 from the second relaxed position to the second flexed position.
[00124] Referring to Figs. 14A-14B, as the ram 112 is moved distally relative to the latch 110 by the energy source 114, the ram notch 232 may align with the second latch member 222. The forces produced by the needle guard return 236 and the angled surface of the second protrusion 226 and latch engagement feature 184 move the second latch member 222 from the second relaxed position to the second flexed position. The second latch member 222 being received in the ram notch 232 may allow the latch engagement feature 184 to move distally past the second protrusion 226, thereby allowing the trigger 108 and needle guard 106 to move into the lockout position. The ram 112 may move distally at least 90% of the way through the medicament container 102 before the second protrusion 226 is received in the ram notch 232.
[00125] Referring to Figs. 15A-15B, the injector 10 in the lockout state may have at least a portion of the trigger 108 (e.g., latch engagement feature 184) engaged between the latch 110 and the medicament container 102 when the needle guard 106 is in the lockout position. The needle guard 106 may extend the second distance from the front housing 116 when the needle guard 106 is in the lockout position. This engagement may prevent movement of the needle guard distally or proximally along the longitudinal axis AL. The injector 10 may be a single use injector. The injector 10 may not be used again once the needle guard 106 is moved into the lockout position.
[00126] Referring to Fig. 18, there is shown a second embodiment of the front housing 116, generally designated 1116. The front housing 1116 is similar to the first embodiment of the front housing 116 except that the front housing 1116 is configured to receive a smaller medicament container (not shown). The medicament container may be configured to hold, for example, 5 mL of a medicament. The window 1122 may be shorter than window 122 along the longitudinal axis AL.
[00127] Due to the high volumes that can be delivered by the injector 10, a user may want to monitor the progress of the dose and confirm an end of dose. As such, injector 10 may include a dose status indicator. Referring to Fig. 21, there is shown a second embodiment of the rear housing 118, generally designated 2118. The rear housing 2118 is similar to the first embodiment of the rear housing 118 except that the rear housing 2118 may include a window 2238 defined thereon. In some embodiments, the window 2238 is defined on the front housing 2116. In some embodiments, the window 2238 is window 2122.
[00128] The window 2238 may be configured to enable a user to view movement of the ram 2112 relative to the rear housing 2118 during an injection. The window 2238 may be a generally ovular shape extending along the longitudinal axis AL. In some embodiments, the window 2238 may be a rectangular shape. The window 2238 may include a status prong 2240 extending therefrom. The status prong 2240 may extend radially inward toward a center of the window 2238 and may come to a point at an end. The status prong 2240 may be a generally triangular member. The status prong 2240 may be a generally right triangle such that a proximal side of the status prong 2240 is generally perpendicular to the longitudinal axis AL. The window 2238 may include two status prongs 2240 extending toward each other. In some embodiments, the window 2238 includes only one status prong 2240.
[00129] To mitigate premature or accidental triggering, additional material or a stronger material may be added to the trigger body 1176 to increase the resistance to deformation. However, the amount of material that can be added to the trigger body 1176 may be restricted by the cross-sectional area or diameter of the rear housing 1118. Referring to Fig. 19, there is shown a second embodiment of the trigger 108, generally designated 1108. The trigger 1 108 is similar to the first embodiment of the trigger 108 except that trigger 1108 may include a trigger band 1181 disposed thereon. The trigger band 1181 may extend around a circumference of the trigger body 1176. In some embodiments, the trigger band 1181 extends around a portion of the trigger body 1176. In some embodiments, the trigger 1108 includes more than one trigger band 1181. The trigger band 1181 may be made from a metal material. In some embodiments, the trigger band 1181 is made from a plastic or composite material with greater hoop strength than that of the trigger body 1176.
[00130] Referring to Fig. 19, the trigger band 1181 may be located proximate the proximal end of the trigger body 1176. In some embodiments, the trigger band 1181 is spaced apart from the proximal end of the trigger body 1176. The trigger band 1181 may provide improved rigidity of the trigger body 1176 by increasing the hoop strength of the trigger 1108, thereby preventing deformation of the trigger body 1176 under the axial forces produced by the first latch member 1212 prior to use of injector 1010. The trigger band 1181 may be located on a different component of the injector 1010. In some embodiments, the trigger band 1181 is located on the housing 1100, on the trigger 1108, on the latch 1110 or on the ram 1112. In an embodiment that includes a button, for example a button- actuated autoinjector, the trigger band 1181 may be located on the button.
[00131] The trigger band 1181 may be coupled to the trigger body 1176 with an adhesive or welding. In some embodiments, the trigger band 1181 is integrally formed on the trigger body 1176. In some embodiments, the trigger body 1176 may include a burr 1183 (not shown) extending radially from the proximal end thereof. The burr 1 183 may extend around at least a portion of the circumference of the proximal end of the trigger 1108. In some embodiments, more than one burr 1183 is spaced apart around the circumference of the proximal end of the trigger 1108. The trigger band 1181 may be prevented from moving proximally relative to the trigger 1108 past the burr 1183. The trigger band 1181 may be rotatable relative to the trigger body 1176.
[00132] The trigger band 1181 may be configured to resist up to 30 lbs of force for up to three years. In some embodiments, the trigger band 1181 resists at least 8 lbs of force, at least 9 lbs of force, at least 10 lbs of force, at least 11 lbs of force, at least 12 lbs of force, at least 13 lbs of force, at least 14 lbs of force, at least 15 lbs of force, at least 16 lbs of force, at least 17 lbs of force, at least 18 lbs of force, at least 19 lbs of force, at least 20 lbs of force, at least 21 lbs of force, at least 22 lbs of force, at least 23 lbs of force, at least 24 lbs of force, at least 25 lbs of force, at least 26 lbs of force, at least 27 lbs of force, at least 28 lbs of force, at least 29 lbs of force, or at least 30 lbs of force for up to three years. In some embodiments, the trigger band 1181 resists between 8-30 lbs of force, between 9-29 lbs of force, between 10-28 lbs of force, between 11-27 lbs of force, between 12-26 lbs of force, between 13-25 lbs of force, between 14-24 lbs of force, between 15-23 lbs of force, between 16-22 lbs of force, between 17-21 lbs of force, or between 18-20 lbs of force for up to three years.
[00133] Environmental factors, such as increased temperature, can impact the ability of the trigger 1108 to resist deformation. The trigger band 1181 may be configured to resist deformation forces in temperatures up to 40° C for up to three years. In some embodiments, the trigger band 1181 resists deformation forces in temperatures of at least 20° C, at least 25° C, at least 30° C, at least 35° C, at least 40° C, at least 45° C, at least 50° C, at least 55° C, or at least 60° C for up to three years. In some embodiments, the trigger band 1181 resists deformation forces in temperatures between 20° C and 60° C, between 25° C and 55° C, between 30° C and 50° C, or between 35° C and 45° C for up to three years.
[00134] Referring to Figs. 20A-20C, there is shown a third embodiment of the trigger 108, generally designated 2108. The trigger 2108 is similar to the second embodiment of the trigger 1108 except that trigger 2108 may include a trigger band 2181 disposed on an interior thereof. The trigger band 2181 may be configured to engage directly with the first latch member 2212 of the latch 2110 to reduce or prevent deformation of the trigger body 2176. The trigger band 2181 may be disposed on an interior of the trigger body 2176. In some embodiments, the trigger 2108 includes a trigger band 2181 disposed on an interior of the trigger body 2176 and a trigger ring 2180 disposed on an exterior of the trigger body 2176. The trigger band 2181 may be located on a different component of the injector 2010. In some embodiments, the trigger band 2181 is located on the housing 2100, on the trigger 2108, on the latch 21 10 or on the ram 2112. In an embodiment that includes a button, for example a button-actuated autoinjector, the trigger band 2181 may be located on the button.
[00135] Referring to Figs. 20A-20C, the trigger band 2181 may be located proximate the proximal end of the trigger body 2176. In some embodiments, the trigger band 2181 is spaced apart from the proximal end of the trigger body 2176. The trigger band 2181 may dissipate the axial forces produced by the first latch member 2212 prior to use of injector 2010. The trigger band 2181 may provide improved rigidity of the trigger body 2176 by increasing the hoop strength of the trigger 2108, thereby preventing deformation of the trigger body 2176 under the axial forces produced by the first latch member 2212 prior to use of injector 2010. The trigger band 2181 may be located on a different component of the injector 2010. In some embodiments, the trigger band 2181 is located on the housing 2100, on the trigger 2108, on the latch 2110 or on the ram 2112. In an embodiment that includes a button, for example a button-actuated autoinj ector, the trigger band 2181 may be located on the button. [00136] Referring to Figs. 20A-20C, the trigger band 2181 may be prevented from longitudinal movement relative to the trigger body 2176. In some embodiments, the trigger band 2181 is coupled to the trigger body 2176 with an adhesive or welding. In some embodiments, the trigger band 2181 is integrally formed on the trigger body 2176. In some embodiments, the trigger body 2176 may include a burr 2183 (Figs. 21B-20C) extending radially thereof. The burr 2183 may extend around at least a portion of the circumference of the trigger body 2176. In some embodiments, more than one burr 2183 is spaced apart around the circumference of the trigger body 2176. The trigger band 2181 may include a band groove 2185 defined thereon. The band groove 2185 may extend around at least a portion of the circumference of an exterior of the trigger band 2181. In some embodiments, the band groove 2185 extends around the circumference of the trigger band 2181. The band groove 2185 may be shaped and sized to receive at least a portion of the burr 2183 therein. The trigger band 2181 may be prevented from moving proximally relative to the trigger 2108 past the burr 2183. The trigger band 2181 may be allowed to rotate relative to the trigger body 2176 but may be prevented from moving longitudinally relative to the trigger body 2176 by the engagement of the band groove 2185 and the burr 2183.
[00137] Referring to Fig. 21, the ram 2112 may include a dose indicator 2242 defined thereon. The dose indicator 2242 may be a line that extends around at least a portion of the circumference of the ram 2112. In some embodiments, the dose indicator 2242 extends around only a portion of the ram 2112. The dose indicator 2242 may be a solid line. In some embodiments, the dose indicator 2242 is a broken line. The dose indicator 2242 may be colored such that a user can easily identify the dose indicator 2242 on the ram 2112 during an injection.
[00138] When the injector 10 is in the initial state, the dose indicator 2242 may be positioned proximally relative to the window 2238 and may not be visible to a user. In some embodiments, the dose indicator 2242 may be visible at a proximal end of the window 2238 when the injector 10 is in the initial state. During an injection, as the ram 2112 moves distally relative to the rear housing 2118, the dose indicator 2242 may move relative to the window 2238 toward the status prong 2240. This may allow a user to monitor the status and progress of a dose through visual inspection. Referring to Fig. 21, the dose indicator 2242 may be aligned with the status prong 2240 when delivery of the dose is complete. The dose indicator 2242 may be aligned with the proximal side of the status prong 2240 when delivery of the dose is complete. The window 2238 may be integrally formed in the rear housing 2118. In some embodiments, the window 2238 may be removably coupled to the rear housing 2118. In some embodiments, the window 2238 may be removeable and replaceable with any of the windows shown in Figs. 22-29. [00139] Referring to Fig. 22, there is shown a third embodiment of the rear housing 118, generally designated 3118. The rear housing 3118 is similar to the second embodiment of the rear housing 2118 except that the rear housing 3118 may include a ram 3112 having a dose indicator 3242 and a delivery indicator 3243 defined thereon. The dose indicator 3242 may be a line that extends around at least a portion of the circumference of the ram 3112. In some embodiments, the dose indicator 3242 extends around only a portion of the ram 3112. The dose indicator 3242 may be a solid line. In some embodiments, the dose indicator 3242 is a broken line. The dose indicator 3242 may be colored such that a user can easily identify the dose indicator 3242 on the ram 3112 during an injection.
[00140] Referring to Fig. 22, the delivery indicator 3243 may be an indicia on the ram 3112 that extends along the longitudinal axis AL and may be visible by a user through the window 3238. The delivery indicator 3243 may extend along a length of the ram 3112. In some embodiments, the delivery indicator 3243 extends along a portion of the ram 3112. The delivery indicator 3243 may be a broken line such that movement of the ram 3112 relative to the window 3238 and the status prong 3240 may be visible by a user during delivery of the dose. The dose indicator 3242 may be positioned in between two portions of the delivery indicator 3243 to enable a user to view the dose indicator separately from the delivery indicator 3243.
[00141] When the injector 10 is in the initial state, the dose indicator 3242 may be positioned proximally relative to the window 3238 and may not be visible to a user. In some embodiments, the dose indicator 3242 may be visible at a proximal end of the window 3238 when the injector 10 is in the initial state. During an injection, as the ram 3112 moves distally relative to the rear housing 3118 the dose indicator 3242 may move relative to the window 3238 toward the status prong 3240. This may allow a user to monitor the status and progress of a dose through visual inspection. Referring to Fig. 22, the dose indicator 3242 may be aligned with the status prong 3240 when delivery of the dose is complete. The dose indicator 3242 may be aligned with the proximal side of the status prong 3240 when delivery of the dose is complete.
[00142] Referring to Fig. 23, there is shown a fourth embodiment of the rear housing 118, generally designated 4118. The rear housing 4118 is similar to the third embodiment of the rear housing 3118 except that rear housing 4118 may include a ram 4112 having a dose indicator 4242 and a delivery indicator 4243 defined thereon. The dose indicator 4242 may be a line that extends around at least a portion of the circumference of the ram 4112. In some embodiments, the dose indicator 4242 extends around only a portion of the ram 4112. The dose indicator 4242 may be a solid line. In some embodiments, the dose indicator 4242 is a broken line. The dose indicator 4242 may be defined at a proximal side and a distal side by the delivery indicator 4243. As such, the ram 4112 may be colored such that a user can easily identify the dose indicator 4242 during an injection.
[00143] Referring to Fig. 23, the delivery indicator 4243 may be an indicia on the ram 4112 that extends along the longitudinal axis AL and may be visible by a user through the window 4238. The delivery indicator 4243 may extend around at least a portion of the circumference of the ram 4112. In some embodiments, the delivery indicator 4243 extends around only a portion of the ram 4112. The delivery indicator 4243 may extend along a length of the ram 4112. In some embodiments, the delivery indicator 4243 extends along a portion of the ram 4112. The delivery indicator 4243 may be a cross-hatched indicia such that movement of the ram 4112 relative to the window 4238 and the status prong 4240 may be visible by a user during delivery of the dose. The thickness of the lines, the angle of the lines, and the spacing between the lines of the delivery indicator 4243 may be modulated to offer sufficient indicia for a user. The dose indicator 4242 may be positioned in between two portions of the delivery indicator 4243 to enable a user to view the dose indicator separate from the delivery indicator 4243.
[00144] When the injector 10 is in the initial state, the dose indicator 4242 may be positioned proximally relative to the window 4238 and may not be visible to a user. In some embodiments, the dose indicator 4242 may be visible at a proximal end of the window 4238 when the injector 10 is in the initial state. During an injection, as the ram 4112 moves distally relative to the rear housing 4118 the dose indicator 4242 may move relative to the window 4238 toward the status prong 4240. This may allow a user to monitor the status and progress of a dose through visual inspection. Referring to Fig. 23, the dose indicator 4242 may be aligned with the status prong 4240 when delivery of the dose is complete. The dose indicator 4242 may be aligned with the proximal side of the status prong 4240 when delivery of the dose is complete.
[00145] Referring to Fig. 24, there is shown a fifth embodiment of the rear housing 118, generally designated 5118. The rear housing 5118 is similar to the fourth embodiment of the rear housing 4118 except that rear housing 5118 may include a ram 5112 having a dose indicator 5242 and a delivery indicator 5243 defined thereon and the window 5238 may have a status prong 5240 defined on a perimeter thereof. The status prong 5240 may extend radially inward toward a center of the window 5238 and may come to a point at an end. The status prong 5240 may be a generally triangular member. The status prong 5240 may be a generally right triangle such that a proximal side of the status prong 5240 is generally perpendicular to the longitudinal axis AL. The window 5238 may include two status prongs 5240 pointing toward each other. In some embodiments, the window 5238 includes only one status prong 5240. [00146] Referring to Fig. 24, the dose indicator 5242 may be an arrow that is positioned on the ram 5112 and extends radially out from a center of the ram 5112. In some embodiments, the dose indicator 5242 extends around a portion of the ram 51 12. The dose indicator 5242 may be two arrows that extend radially apart from the center of the ram 5112. In some embodiments, the dose indicator 5242 is two arrows separated by the delivery indicator 5243. In some embodiments, the dose indicator 5242 is a line. The dose indicator 5242 may be colored such that a user can easily identify the dose indicator
5242 during an injection.
[00147] Referring to Fig. 24, the delivery indicator 5243 may be an indicia on the ram 5112 that extends along the longitudinal axis AL and may be visible by a user through the window 5238. The delivery indicator 5243 may extend around at least a portion of the circumference of the ram 5112. In some embodiments, the delivery indicator 5243 extends around only a portion of the ram 5112. The delivery indicator 5243 may extend along a length of the ram 5112. In some embodiments, the delivery indicator 5243 extends along a portion of the length of the ram 5112. The delivery indicator
5243 may be a checkered indicia such that movement of the ram 5112 relative to the window 5238 and the status prong 5240 may be visible by a user during delivery of the dose. The thickness of the lines, the angle of the lines and the spacing between the lines of the delivery indicator 5243 may be modulated to offer sufficient indicia for a user. The delivery indicator 5243 may be positioned in between two arrows of the dose indicator 5242 to enable a user to view the dose indicator 5242 separate from the delivery indicator 5243.
[00148] When the injector 10 is in the initial state, the dose indicator 5242 may be positioned proximally relative to the window 5238 and may not be visible to a user. In some embodiments, the dose indicator 5242 may be visible at a proximal end of the window 5238 when the injector 10 is in the initial state. During an injection, as the ram 5112 moves distally relative to the rear housing 5118 the dose indicator 5242 may move relative to the window 5238 toward the status prong 5240. This may allow a user to monitor the status and progress of a dose through visual inspection. Referring to Fig. 24, the dose indicator 5242 may be aligned with the status prong 5240 when delivery of the dose is complete. The dose indicator 5242 may be aligned with the proximal side of the status prong 5240 when delivery of the dose is complete.
[00149] Referring to Fig. 25, there is shown a sixth embodiment of the rear housing 118, generally designated 6118. The rear housing 6118 is similar to the fifth embodiment of the rear housing 5118 except that rear housing 6118 may include a ram 6112 having a dose indicator 6242 defined thereon and the window 6238 may have a status aperture 6241 extending across the window 6238. The window 6238 may include a status aperture 6241 defined thereon and extending across at a portion of the window 6238 between a proximal end and a distal end. The status aperture 6241 may be shaped and sized such that a user can view the dose indicator 6242 therethrough when the delivery of a dose is complete. The status aperture 6241 may extend radially across the window 6238. Tn some embodiments, the status aperture 6241 extends longitudinally across the window 6238.
[00150] Referring to Fig. 25, the dose indicator 6242 may be a circle that is positioned on the ram 6112. The dose indicator 6242 may be located at a center of the ram 6112 relative to the window 6238. In some embodiments, the dose indicator 6242 is a square or another polygonal shape. The dose indicator 6242 may be colored such that a user can easily identify the dose indicator 6242 during an injection.
[00151] When the injector 10 is in the initial state, the dose indicator 6242 may be positioned proximally relative to the window 6238 and may not be visible to a user. In some embodiments, the dose indicator 6242 may be visible at a proximal end of the window 6238 when the injector 10 is in the initial state. During an injection, as the ram 6112 moves distally relative to the rear housing 6118 the dose indicator 6242 may move relative to the window 6238 toward the status aperture 6241. This may allow a user to monitor the status and progress of a dose through visual inspection. Referring to Fig. 25, the dose indicator 6242 may be aligned with and visible through the status aperture 6241 when delivery of the dose is complete. The dose indicator 6242 may be aligned with a center of the status aperture 6241 when delivery of the dose is complete.
[00152] Referring to Fig. 26, there is shown a seventh embodiment of the rear housing 118, generally designated 7118. The rear housing 7118 is similar to the sixth embodiment of the rear housing 6118 except that rear housing 7118 may include a ram 7112 having a dose indicator 7242 defined thereon and the window 7238 may have a status beam 7247 extending across the window 7238. The window 7238 may include a status beam 7247 defined thereon extending across a portion of the window 7238 between a proximal end and a distal end. The status beam 7247 may be shaped and sized such that a user can view the dose indicator 7242 positioned proximate the status beam 7247 when the delivery of a dose is complete. The status beam 7247 may extend radially across the window 7238.
[00153] Referring to Fig. 26, the dose indicator 7242 may be an arrow that is positioned on the ram 7112 and extends longitudinally toward the proximal end or distal end of the ram 7112. In some embodiments, the dose indicator 7242 extends a portion of a length of the ram 7112. The dose indicator 7242 may be two arrows that extend longitudinally toward each other on the ram 7112. In some embodiments, the dose indicator 7242 is two arrows separated by a gap sized and shaped to allow the status beam 7247 to be viewed therebetween. The dose indicator 7242 may be colored such that a user can easily identify the dose indicator 7242 during an injection.
[00154] When the injector 10 is in the initial state, the dose indicator 7242 may be positioned proximally relative to the window 7238 and may not be visible to a user. In some embodiments, the dose indicator 7242 may be visible at a proximal end of the window 7238 when the injector 10 is in the initial state. During an injection, as the ram 7112 moves distally relative to the rear housing 7118 the dose indicator 7242 may move relative to the window 7238 toward the status beam 7247. This may allow a user to monitor the status and progress of a dose through visual inspection. Referring to Fig. 26, the dose indicator 7242 may be aligned with the status beam 7247 when delivery of the dose is complete. The dose indicator 7242 may be an arrow positioned proximate and pointing toward the status beam 7247 when delivery of the dose is complete.
[00155] Referring to Fig. 27, there is shown an eighth embodiment of the rear housing 118, generally designated 8118. The rear housing 8118 is similar to the seventh embodiment of the rear housing 7118 except that rear housing 8118 may include a ram 8112 having a delivery indicator 8243 defined thereon. The delivery indicator 8243 may be an indicia on the ram 8112 that extends along the longitudinal axis AL and may be visible by a user through the window 8238. The delivery indicator 8243 may extend around the circumference of the ram 8112. In some embodiments, the delivery indicator 8243 extends around only a portion of the ram 8112. The delivery indicator 8243 may extend along a length of the ram 8112. In some embodiments, the delivery indicator 8243 extends along a portion of the length of the ram 8112. The delivery indicator 8243 may be a cross-hatched indicia such that movement of the ram 8112 relative to the window 8238 may be visible by a user during delivery of the dose. The thickness of the lines, the angle of the lines and the spacing between the lines of the delivery indicator 8243 may be modulated to offer sufficient indicia for a user.
[00156] When the injector 10 is in the initial state, the delivery indicator 8243 may be positioned proximally relative to the window 8238 and may not be visible to a user. In some embodiments, the delivery indicator 8243 may be visible at a proximal end of the window 8238 when the injector 10 is in the initial state. During an injection, as the ram 8112 moves distally relative to the rear housing 8118 the delivery indicator 8243 may move relative to the window 8238. This may allow a user to monitor the status and progress of a dose through visual inspection. Referring to Fig. 27, the delivery indicator 8243 may completely occlude the window 8238 when delivery of the dose is complete.
[00157] Referring to Fig. 28, there is shown a ninth embodiment of the rear housing 118, generally designated 9118. The rear housing 9118 is similar to the eighth embodiment of the rear housing 8118 except that rear housing 9118 may include a ram 9112 having a delivery message 9251 defined thereon. The delivery message 9251 may be an indicia on the ram 9112 that can be read by a user to determine a dose status. The delivery message 9251 may be the word “DONE” or similar. The delivery message 9251 may extend around the circumference of the ram 9112. In some embodiments, the delivery message 9251 extends around only a portion of the ram 9112. The delivery message 9251 may be a word or icon disposed on the ram 9112 such that movement of the ram 9112 relative to the window 9238 may be visible by a user during delivery of the dose. The thickness of the letters and the spacing between the letters or icons of the delivery message 9251 may be modulated to offer sufficient indicia for a user.
[00158] When the injector 10 is in the initial state, the delivery message 9251 may be positioned proximally relative to the window 9238 and may not be visible to a user. In some embodiments, the delivery message 9251 may be visible at a proximal end of the window 9238 when the injector 10 is in the initial state. During an injection, as the ram 9112 moves distally relative to the rear housing 9118, the delivery message 9251 may move relative to the window 9238 toward the distal end thereof. This may allow a user to monitor the status and progress of a dose through vi sual inspection. Referring to Fig. 28, the delivery message 9251 may be proximate the distal end of the window 8238 when delivery of the dose is complete.
[00159] Referring to Fig. 29, there is shown a tenth embodiment of the rear housing 118, generally designated 10118. The rear housing 10118 is similar to the ninth embodiment of the rear housing 9118 except that rear housing 10118 may include a ram 10112 having a dose indicator 10242, a delivery indicator 10243 and a delivery message 10251 defined thereon and the window 10238 may have a status recess 10249 defined on a perimeter thereof. In some embodiments, the window 10238 is defined on the front housing 101 16. In some embodiments, the window 10238 is window 10122.
[00160] The window 10238 may be configured to enable a user to view movement of the ram 10112 relative to the rear housing 10118 during an injection. The window 10238 may be a generally ovular shape extending along the longitudinal axis AL. The window 10238 may have a rounded proximal end and a flat distal end with a status recess 10249 extending from the distal end. The status recess 10249 may be a generally circular member and may extend distally from the distal end of the window 10238. The status recess 10249 may be shaped and sized to allow a user to view the dose indicator therein upon completion of delivery of a dose. In some embodiments, the window 10238 may be a rectangular shape.
[00161] Referring to Fig. 29, the dose indicator 10242 may be a circle that is positioned on the ram 10112. The dose indicator 10242 may be located at a center of the ram 10112 relative to the window 10238. In some embodiments, the dose indicator 10242 is a square or another polygonal shape. The dose indicator 10242 may be colored such that a user can easily identify the dose indicator 10242 during an injection.
[00162] Referring to Fig. 29, the delivery indicator 10243 may be an indicia on the ram 10112 that extends along the longitudinal axis AL and may be visible by a user through the window 10238. The delivery indicator 10243 may extend along a length of the ram 10112. In some embodiments, the delivery indicator 10243 extends along a portion of the length of the ram 10112. The delivery indicator 10243 may be a line with a plurality of waves or squiggles such that movement of the ram 10112 relative to the window 10238 may be visible by a user during delivery of the dose. The thickness of the line and the spacing between the waves of the delivery indicator 10243 may be modulated to offer sufficient indicia for a user.
[00163] Referring to Fig. 29, the delivery message 10251 may be an indicia on the ram 10112 that can be read by a user to determine a dose status. The delivery message 10251 may be the word “DONE” or similar. The delivery message 10251 may extend around the circumference of the ram 10112. In some embodiments, the delivery message 10251 extends around only a portion of the ram 10112. The delivery message 10251 may be a word or icon disposed on the ram 10112 such that movement of the ram 10112 relative to the window 10238 may be visible by a user during delivery of the dose. The thickness of the letters and the spacing between the letters or icons of the delivery message 10251 may be modulated to offer sufficient indicia for a user.
[00164] When the injector 10 is in the initial state, at least one of the dose indicator 10242, the delivery message 10251 and the delivery indicator 10243 may be positioned proximally relative to the window 10238 and may not be visible to a user. In some embodiments, at least one of dose indicator 10242, the delivery message 10251 and the delivery indicator 10243 may be visible at a proximal end of the window 10238 when the injector 10 is in the initial state. During an injection, as the ram 10112 moves distally relative to the rear housing 10118, the dose indicator 10242, the delivery message 10251 and the delivery indicator 10243 may move relative to the window 10238. The dose indicator 10232 may move toward the status recess 10249 extending from the distal end of the window 10238. The delivery message 10251 may move toward the distal end of the window 10238. This may allow a user to monitor the status and progress of a dose through visual inspection. Referring to Fig. 29, the dose indicator 10242 may be aligned with and visible through the status recess 10249 when delivery of the dose is complete. The delivery message 10251 may be positioned proximate the distal end of the window 10238 when delivery of the dose is complete.
[00165] The term “about” or “approximately” is used herein to provide literal support for the exact number that it precedes, as well as a number that is near to or approximately the number that the term precedes. In determining whether a number is near to or approximately a specifically recited number, the near or approximating unrecited number may be a number, which, in the context in which it is presented, provides the substantial equivalent of the specifically recited number. It should be appreciated that all numerical values and ranges disclosed herein are approximate values and ranges, whether “about” is used in conjunction therewith. It should also be appreciated that the term “about,” as used herein, in conjunction with a numeral refers to a value that may be ±0.01% (inclusive), ±0.1% (inclusive), ±0.5% (inclusive), ±1% (inclusive) of that numeral, ±2% (inclusive) of that numeral, ±3% (inclusive) of that numeral, ±5% (inclusive) of that numeral, ±10% (inclusive) of that numeral, or ±15% (inclusive) of that numeral. It should further be appreciated that when a numerical range is disclosed herein, any numerical value falling within the range is also specifically disclosed.
[00166] It will be appreciated by those skilled in the art that changes could be made to the exemplary embodiments shown and described above without departing from the broad inventive concepts thereof. It is to be understood that the embodiments and claims disclosed herein are not limited in their application to the details of construction and arrangement of the components set forth in the description and illustrated in the drawings. Rather, the description and the drawings provide examples of the embodiments envisioned. The embodiments and claims disclosed herein are further capable of other embodiments and of being practiced and carried out in various ways.
[00167] Specific features of the exemplary embodiments may or may not be part of the claimed invention and various features of the disclosed embodiments may be combined. Unless specifically set forth herein, the terms “a,” “an” and “the” are not limited to one element but instead should be read as meaning “at least one.” Finally, unless specifically set forth herein, a disclosed or claimed method should not be limited to the performance of its steps in the order written, and one skilled in the art can readily appreciate that the steps may be performed in any practical order.

Claims

CLAIMS What is claimed is:
1. An injector comprising: a housing having a proximal end, a distal end, and a longitudinal axis extending between the proximal end and the distal end; a medicament container disposed within the housing and containing a volume of a medicament; a needle coupled to a distal end of the medicament container and in fluid communication therewith; a needle guard at least partially disposed within the distal end of the housing and moveable relative to the housing along the longitudinal axis from an extended position where the needle guard extends distally from the housing to cover the needle, to a retracted position where the needle guard is moved proximally to at least partially expose the needle, to a lockout position where the needle guard extends distally from the housing to cover the needle; a trigger disposed within the housing and coupled to the needle guard; a latch disposed within the housing, the latch configured to engage the trigger; a ram movable relative to the latch; and an energy source configured to urge the ram distally relative to the latch along the longitudinal axis, wherein the trigger is engageable with the ram such that movement of the needle guard from the retracted position to the lockout position is dependent upon the position of the ram relative to the latch.
2. The injector of claim 1, wherein the latch includes a latch body, a first latch member moveable between a first flexed position wherein the first latch member is flexed radially outward relative to the latch body and a first relaxed position wherein the first latch member is generally flush with the latch body, and a second latch member moveable between a second flexed position wherein the second latch member is flexed radially inward relative to the latch body and a second relaxed position wherein the second latch member is generally flush with the latch body.
3. The injector of claim 2, wherein the first latch member in the first flexed position prevents movement of the needle guard from the retracted position toward the lockout position.
4. The injector of claim 3, wherein movement of the ram distally past the first latch member allows the first latch member to move from the first flexed position to the first relaxed position thereby allowing the needle guard to move from the retracted position toward the lockout position.
5. The injector of claim 4, wherein the second latch member in the second relaxed position prevents movement of the needle guard into the lockout position.
6. The injector of claim 5, wherein movement of the ram distally past the second latch member allows the second latch member to move from the second relaxed position to the second flexed position thereby allowing the needle guard to move into the lockout position.
7. The injector of claim 6, wherein at least a portion of the trigger is engaged between the latch and the medicament container when the needle guard is in the lockout position, thereby preventing movement of the needle guard along the longitudinal axis.
8. The injector of claim 2, wherein the first latch member comprises a first flexible arm extending along the longitudinal axis and a first protrusion extending radially inward therefrom.
9. The injector of claim 8, wherein the ram includes a ram body, and wherein a ram aperture extends through the ram body, the ram aperture receiving at least a portion of the first protrusion when the needle guard is in the extended position.
10. The injector of claim 9, wherein the ram aperture receiving the first protrusion prevents movement of the ram relative to the latch and relative to the housing.
11. The injector of claim 2, wherein movement of the needle guard from the extended position to the retracted position aligns a window of the trigger with the first latch member, thereby allowing the first latch member to move into the first flexed position and allowing movement of the ram relative to the latch.
12. The injector of claim 11, wherein the medicament container includes a plunger disposed therein, and wherein the ram engages the plunger thereby moving the plunger relative to the medicament container.
13. The injector of claim 12, wherein movement of the plunger relative to the medicament container ejects the volume of the medicament from the medicament container through a needle disposed at a distal end thereof.
14. The injector of claim 2, wherein the second latch member comprises a second flexible arm extending along the longitudinal axis and a second protrusion extending radially outward therefrom.
15. The injector of claim 1 further comprising: a needle guard return configured to bias the needle guard distally relative to the housing.
16. The injector of claim 15, wherein the needle guard return is disposed between a proximal end of the trigger and a distal end of the latch.
17. The injector of claim 1, wherein the trigger comprises a trigger ring disposed thereon configured to prevent radial deformation of the trigger.
18. The injector of claim 17, wherein the trigger ring is disposed on an outer surface of the trigger.
19. The injector of claim 17, wherein the trigger ring is disposed on an inner surface of the trigger.
20. The injector of claim 1, further comprising: a window extending through the housing; and a dose indicator disposed on the ram, wherein the dose indicator is viewable through the window during delivery of a dose of the medicament to a subject.
21. The injector of claim 20, wherein the ram and dose indicator are moveable relative to the window when the energy source urges the ram distally relative to the latch during delivery of the dose of the medicament to a subject.
22. The injector of claim 21, wherein the window includes a status indicator disposed thereon, where the dose indicator is positioned proximate the status indicator when delivery of the dose of the medicament is complete.
23. The injector of claim 22, wherein the dose indicator is aligned with the status indicator when delivery of the dose of the medicament is complete.
24. The injector of claim 1, wherein a distal end of the needle guard extends a first distance from the housing in the extended position, wherein the distal end of the needle guard extends a second distance from the housing in the lockout position, and wherein the second distance is greater than the first distance.
25. The injector of claim 1, wherein the latch is fixed relative to the housing, and wherein the medicament container is fixed relative to the housing.
26. The injector of claim 1, wherein the volume of the medicament is at least 10 mb.
27. An injector comprising: a housing having a proximal end, a distal end and a longitudinal axis extending between the proximal end and the distal end; a medicament container disposed within the housing and containing a volume of a medicament; a needle coupled to a distal end of the medicament container and in fluid communication therewith; a needle guard at least partially disposed within the distal end of the housing and moveable relative to the housing along the longitudinal axis from an extended position wherein the needle guard extends distally from the housing to cover the needle, to a retracted position wherein the needle guard is moved proximally to at least partially expose the needle, to a lockout position wherein the needle guard extends distally from the housing to cover the needle; a trigger disposed within the housing and coupled to the needle guard; a latch disposed within the housing, the latch configured to engage the trigger and comprising a latch body, a first latch member moveable between a first flexed position wherein the first latch member is flexed radially outward relative to the latch body and a first relaxed position wherein the first latch member is generally flush with the latch body, and a second latch member moveable between a second flexed position wherein the second latch member is flexed radially inward relative to the latch body and a second relaxed position wherein the second latch member is generally flush with the latch body; a ram movable relative to the latch; an energy source configured to urge the ram distally along the longitudinal axis; and a needle guard return configured to bias the needle guard distally relative to the housing, wherein the trigger is engageable with the ram such that movement of the needle guard from the retracted position to the lockout position is dependent upon the position of the ram, and wherein the needle guard return is disposed between a proximal end of the trigger and a distal end of the housing.
28. An injector comprising: a housing having a proximal end, a distal end, and a longitudinal axis extending between the proximal end and the distal end; a housing collar defined on the housing proximate the distal end; and a cap removably coupled to the distal end of the housing, the cap having a cap body and a cap collar, wherein the cap is threadedly coupled to the housing such that rotation of the cap about the longitudinal axis in a first direction urges the cap distally relative to the housing and rotation of the cap in a second direction urges the cap proximally relative to the housing, wherein the housing collar prevents distal movement of the cap collar relative to the housing collar, and wherein the cap collar is separated from the cap body and retained on the housing when the cap is rotated in the first direction.
29. The injector of claim 28 further comprising: a medicament container disposed within the housing and containing a volume of a medicament; a needle coupled to a distal end of the medicament container and in fluid communication therewith; and a needle guard at least partially disposed within the distal end of the housing and moveable relative to the housing along the longitudinal axis.
30. The injector of claim 29, wherein the cap includes an engagement thread extending inward from the cap body, the engagement thread configured to engage the needle guard to prevent proximal movement of the needle guard when the cap is coupled to the housing.
31. The injector of claim 29, wherein the cap includes a needle shield receiver defined on a distal end thereof, the needle shield receiver configured to couple the cap to a needle shield removably coupled to the needle when the cap is coupled to the housing, and wherein removal of the cap from the housing removes the needle shield from the needle.
32. An injector comprising: a housing having a proximal end, a distal end, and a longitudinal axis extending between the proximal end and the distal end; a medicament container disposed within the housing and containing a volume of a medicament; a needle coupled to a distal end of the medicament container and in fluid communication therewith; a needle guard at least partially disposed within the distal end of the housing and moveable relative to the housing along the longitudinal axis from an extended position where the needle guard extends distally from the housing to cover the needle, to a retracted position where the needle guard is moved proximally to at least partially expose the needle, to a lockout position where the needle guard extends distally from the housing to cover the needle; a trigger disposed within the housing and coupled to the needle guard, the trigger comprising a trigger ring configured to prevent radial deformation of the trigger; a latch disposed within the housing, the latch configured to engage the trigger; a ram movable relative to the latch; and an energy source configured to urge the ram distally relative to the latch along the longitudinal axis, wherein the trigger is engageable with the ram such that movement of the needle guard from the retracted position to the lockout position is dependent upon the position of the ram relative to the latch.
PCT/US2025/020376 2024-03-19 2025-03-18 Autoinjector Pending WO2025199106A1 (en)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US202463567105P 2024-03-19 2024-03-19
US63/567,105 2024-03-19
US202563758264P 2025-02-13 2025-02-13
US63/758,264 2025-02-13

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Citations (7)

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US20130150803A1 (en) * 2011-12-08 2013-06-13 Unitract Syringe Pty Ltd Accurate dose control mechanisms and drug delivery syringes
US20160151586A1 (en) * 2013-07-09 2016-06-02 Sanofi-Aventis Deutschland Gmbh Autoinjector
US20200171248A1 (en) * 2015-04-20 2020-06-04 Antares Pharma, Inc. Injection Device
US20200289754A1 (en) * 2017-10-30 2020-09-17 Sanofi Injector Device
US20210338933A1 (en) * 2018-07-20 2021-11-04 Novo Nordisk A/S Autoinjection device having dose logging
WO2023061769A1 (en) * 2021-10-14 2023-04-20 Shl Medical Ag Sub-assembly for a medicament delivery device

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2005007238A (en) * 2003-06-17 2005-01-13 Toyo Seikan Kaisha Ltd Trigger dispenser
US20130150803A1 (en) * 2011-12-08 2013-06-13 Unitract Syringe Pty Ltd Accurate dose control mechanisms and drug delivery syringes
US20160151586A1 (en) * 2013-07-09 2016-06-02 Sanofi-Aventis Deutschland Gmbh Autoinjector
US20200171248A1 (en) * 2015-04-20 2020-06-04 Antares Pharma, Inc. Injection Device
US20200289754A1 (en) * 2017-10-30 2020-09-17 Sanofi Injector Device
US20210338933A1 (en) * 2018-07-20 2021-11-04 Novo Nordisk A/S Autoinjection device having dose logging
WO2023061769A1 (en) * 2021-10-14 2023-04-20 Shl Medical Ag Sub-assembly for a medicament delivery device

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