WO2025193940A1 - Delivery apparatus with removable clip - Google Patents

Abstract

A delivery apparatus configured to deliver a prosthetic valve can include a handle which can include an adjustment device to adjust the axial position of the first shaft relative to the second shaft. The adjustment mechanism can be used to apply a preselected amount of tension to the first shaft which can result in compression between a distal end of the second shaft and a proximal end of the prosthetic valve which maintains a crimped prosthetic valve adjacent to the distal end portion of the second shaft during delivery. The handle can also include a removable clip, for assisting users in accurately and uniformly applying the preselected tension to the first shaft.

Description

DELIVERY APPARATUS WITH REMOVABLE CLIP

CROSS REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. Provisional Patent Application

No. 63/565,710, filed March 15, 2024, which is incorporated herein by reference in its entirety.

FIELD

[0002] The present disclosure concerns delivery apparatuses, systems, and methods for implantation of a prosthetic implants such as stents and/or prosthetic heart valves.

BACKGROUND

[0003] The human heart can suffer from various valvular diseases. These valvular diseases can result in significant malfunctioning of the heart and ultimately require repair of the native valve or replacement of the native valve with an artificial valve. There are a number of known repair devices (for example, stents) and artificial valves, as well as a number of known methods of implanting these devices and valves in humans. Percutaneous and minimally-invasive surgical approaches are used in various procedures to deliver prosthetic medical devices to locations inside the body that are not readily accessible by surgery or where access without surgery is desirable. In one specific example, a prosthetic heart valve can be mounted in a crimped state on the distal end of a delivery apparatus and advanced through the patient’s vasculature (for example, through a femoral artery and the aorta) until the prosthetic heart valve reaches the implantation site in the heart. The prosthetic heart valve is then expanded to its functional size, for example, by inflating a balloon on which the prosthetic valve is mounted, actuating a mechanical actuator that applies an expansion force to the prosthetic heart valve, or by deploying the prosthetic heart valve from a sheath of the delivery apparatus so that the prosthetic heart valve can self-expand to its functional size.

SUMMARY

[0004] Described herein are prosthetic heart valves, delivery apparatus, and methods for implanting prosthetic heart valves. The disclosed removable clip for a delivery apparatus and methods can, for example, provide reduced likelihood of a gap forming between the distal end portion of a guide catheter shaft and the proximal end of a prosthetic device. As such, the devices and methods disclosed herein can, among other things, overcome one or more of the deficiencies of typical prosthetic heart valves and their delivery apparatus.

[0005] In one of its basic configurations, a removable clip for a delivery apparatus comprises a clasp, wherein the clasp comprises an inner cavity and the inner cavity defines a longitudinal axis and a tongue coupled to the clasp and extending in a distal direction. This basic configuration can preferably be provided with any one or more of the features described elsewhere herein, in particular with those of the examples described hereafter. However, it should be understood that the basic configuration can preferably also be provided with any one or more of the features shown in the figures and/or described in conjunction with the figures, either in addition to or alternatively to the features of the examples described hereafter.

[0006] : In some examples, the removable clip can comprise a ridge coupled to the clasp and extending radially outward from the longitudinal axis. In some examples, the removable clip further comprises an alignment projection which is coupled to the ridge radially outward from the tongue and extends in a distal direction. In some examples, the removable clip further comprises user instructions printed on the alignment projection.

[0007] In some examples, the removable clip further comprises one or more tabs coupled to the ridge and the clasp. In some examples, the one or more tabs comprises two tabs wherein pressing the tabs results in the clasp expanding radially outward.

[0008] In some examples, the tongue extends less than 0.25 inches in the distal direction. In some examples, the tongue extends between 0.5- 1.5 inches in the distal direction.

[0009] In some examples, the clasp defines a circumferential portion of an annular cylinder. In some examples there are a plurality of protrusions on an inner surface of the clasp.

[0010] In some examples, a delivery apparatus for delivering a medical implant, comprises the removable clip and further comprises: a first shaft having a proximal end portion and a distal end portion; a second shaft, wherein the second shaft extends over the first shaft and has a proximal end portion and a distal end portion; and a handle portion comprising: a sliding member coupled to the proximal end portion of the first shaft; and a rotatable knob that is rotatably coupled to the proximal end portion of the second shaft and operatively coupled to the sliding member so rotation of the rotatable knob relative to the first shaft results in translational movement of the sliding member and first shaft relative to the second shaft; wherein the clasp is disposed around a proximal end portion of the sliding member.

[0011] In some examples, the sliding member is selectively coupled to the proximal end portion of the first shaft. In some examples, a balloon is disposed on the distal end portion of the first shaft and an expandable prosthetic medical device disposed around the balloon.

[0012] In some examples, rotation of the rotatable knob relative to the first shaft results in compression between a distal end portion of the second shaft and a proximal end portion of the expandable prosthetic medical device.

[0013] In some examples, the tongue is sized and shaped to extend into a gap between the sliding member and the rotatable knob. In some examples, there are one or more grooves on an exterior surface of the sliding member.

[0014] In some examples, a method of preparing a delivery apparatus for insertion into a patient’s vasculature, comprises: a delivery apparatus with a removable clip installed on a sliding member wherein the sliding member is selectively coupled to a proximal end portion of a first shaft; rotating a rotatable knob wherein the rotatable knob is rotatably coupled to the proximal end portion of a second shaft and operatively coupled to the sliding member so rotation of the rotatable knob relative to the first shaft results in translational movement of the sliding member and first shaft relative to the second shaft and wherein translational movement of the first shaft relative to the second shaft results in compression of a distal end of the second shaft against a proximal end of a medical implant disposed around a distal end of the first shaft; compressing the distal end of the second shaft against a proximal end of a medical implant to a preselected amount of compression; and removing a removable clip from the sliding member when a preselected amount of compression has been applied.

[0015] In some examples, prior to removing the removable clip, pressing two tabs toward one another which resulting in sidewalls flaring radially outward. In some examples, the removable clip comprises a marking indicating when the preselected amount of compression has been applied and the step of rotating a rotatable knob comprises rotating the rotatable knob until the marking is at a proximal end of the rotatable knob. In some examples the delivery apparatus is introduced into a patient’s vasculature after removing the removable clip. [0016] The above method(s) can be performed on a living animal or on a simulation, such as on a cadaver, cadaver heart, anthropomorphic ghost, simulator (for example, with body parts, heart, tissue, etc. being simulated).

[0017] The various innovations of this disclosure can be used in combination or separately. This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the detailed description. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. The foregoing and other objects, features, and advantages of the disclosure will become more apparent from the following detailed description, claims, and accompanying figures.

BRIEF DESCRIPTION OF THE DRAWINGS

[0018] FIG. 1 is a side view of a portion of a delivery apparatus for implanting a prosthetic heart valve, according to one example.

[0019] FIG. 2 is a cross-sectional view of the proximal handle portion of the delivery apparatus of FIG. 1 with the removable clip installed.

[0020] FIG. 3 is a perspective view of the slider of the delivery apparatus of FIG. 1.

[0021] FIGS. 4A-4B are perspective views of two examples of the removable clip of the delivery apparatus of FIG. 1.

[0022] FIGS. 5A-5C depict the interaction between the removable clip and the handle portion during preparation of the delivery apparatus of FIG. 1.

[0023] FIGS. 6A-6B depict the in vivo positions of the steerable section of the guide catheter as the delivery apparatus of FIG. 1 traverses the patient’s vasculature.

[0024] FIG. 7 is a perspective view of another example of a removable clip to be used with the delivery apparatus of FIG. 1

[0025] FIGS. 8A-8B depict the interaction between the removable clip of FIG. 7 and a handle portion during preparation of the delivery apparatus.

[0026] FIGS. 9A-9E depict several examples of user instructions to be used with any of the removable clips herein.

[0027] FIG. 10 depicts an example of a prosthetic heart valve that can be implanted using any of the delivery apparatuses disclosed herein. DETAILED DESCRIPTION

General Considerations

[0028] For purposes of this description, certain aspects, advantages, and novel features of examples of this disclosure are described herein. The disclosed methods, apparatus, and systems should not be construed as being limiting in any way. Instead, the present disclosure is directed toward all novel and nonobvious features and aspects of the various disclosed examples, alone and in various combinations and sub-combinations with one another. The methods, apparatus, and systems are not limited to any specific aspect or feature or combination thereof, nor do the disclosed examples require that any one or more specific advantages be present or problems be solved.

[0029] Although the operations of some of the disclosed examples are described in a particular, sequential order for convenient presentation, it should be understood that this manner of description encompasses rearrangement, unless a particular ordering is required by specific language set forth below. For example, operations described sequentially may in some cases be rearranged or performed concurrently. Moreover, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed methods can be used in conjunction with other methods. Additionally, the description sometimes uses terms like “provide” or “achieve” to describe the disclosed methods. These terms are high-level abstractions of the actual operations that are performed. The actual operations that correspond to these terms may vary depending on the particular implementation and are readily discernible by one of ordinary skill in the art.

[0030] As used in this application and in the claims, the singular forms “a,” “an,” and “the” include the plural forms unless the context clearly dictates otherwise. Additionally, the term “includes” means “comprises.” Further, the term “coupled” generally means physically, mechanically, chemically, magnetically, and/or electrically coupled or linked and does not exclude the presence of intermediate elements between the coupled or associated items absent specific contrary language.

[0031] As used herein, the term “proximal” refers to a position, direction, or portion of a device that is closer to the user and further away from the implantation site. As used herein, the term “distal” refers to a position, direction, or portion of a device that is further away from the user and closer to the implantation site. Thus, for example, proximal motion of a device is motion of the device away from the implantation site and toward the user (for example, out of the patient’s body), while distal motion of the device is motion of the device away from the user and toward the implantation site (for example, into the patient’s body). The terms “longitudinal” and “axial” refer to an axis extending in the proximal and distal directions, unless otherwise expressly defined.

[0032] As used herein, “e.g.” means “for example,” and “i.e.” means “that is.” Overview of an Exemplary Delivery Apparatus for Implanting a Prosthetic Valve [0033] A delivery apparatus for implanting a prosthetic device (for example, a transcatheter heart valve or a stent) via a patient’s vasculature can, in some examples, include a removable clip. The delivery apparatus can comprise a balloon catheter which can extend through a guide catheter (also referred to as a “flex catheter” and/or a “steerable catheter”), and a crimped prosthetic device can be positioned around a balloon at a distal end of the balloon catheter. The balloon and the crimped prosthetic device can enter the vasculature of a patient through an introducer sheath and, once the balloon and the crimped prosthetic device reach a suitable location in the body, the prosthetic device eventually can be expanded at the treatment site. The prosthetic device is advanced to the vicinity of the deployment location (for example, at the native aortic valve) and the adjustment device can further be used to position the prosthetic device relative to the desired deployment location. In some examples, prior to insertion into the vasculature of a patient, a preselected amount of tension is applied to the intermediate shaft. As this tension is applied, it results in compression between a proximal end of the prosthetic device and a distal end portion of the guide catheter shaft.

[0034] The removable clips disclosed herein can, for example, assist users to correctly apply the preselected amount of tension during the preparation of the delivery apparatus. The removable clip has the advantage of increasing uniformity and quality control during preparation of the delivery apparatus. The application of the preselected amount of tension to the intermediate shaft (and the resulting compression between a proximal end of the prosthetic device and a distal end portion of the guide catheter shaft) can help to maintain a crimped prosthetic device adjacent to the distal end portion of a steerable guide catheter as it is guided through the patient’s vasculature. This step can keep the distal end of the guide catheter and the proximal end of the prosthetic device in close proximity as they are navigated through the patient’s vasculature. Maintaining the distal end of the guide catheter against or in close proximity to the proximal end of the prosthetic device can provide one or more advantages such as preventing the prosthetic device from moving relative to the balloon and enabling the prosthetic device to pass with less friction through the patient’s vasculature.

[0035] FIG. 1 shows a delivery apparatus 10, according to one example, that can be used to implant a medical implant, such as an expandable prosthetic heart valve 12, (e.g., prosthetic valve 400 of FIG. 10), or another type of expandable prosthetic medical device (such as a stent). In some embodiments, the delivery apparatus 10 is specifically adapted for use in introducing a prosthetic valve into a heart. The delivery apparatus 10 is a balloon catheter comprising a handle 20 and a steerable, guide catheter shaft 22 (also referred to as a “second shaft,” “outer shaft,” and/or “steerable shaft”) extending distally from the handle 20. The delivery apparatus 10 can further comprise an intermediate shaft 26 (which also may be referred to as a “first shaft” and/or a “balloon shaft”) that extends proximally from the handle 20 and distally from the handle 20, the portion extending distally from the handle 20 also extending coaxially through the guide catheter shaft 22.

[0036] The handle 20 can include a steering mechanism configured to adjust the curvature of the steerable section 68 (FIGS. 6A-6B) of the delivery apparatus 10. The curvature of the steerable section 68 can be adjusted by an operator to assist in guiding the delivery apparatus 10 through the patient’s vasculature, and in particular, the aortic arch. The steerable section 68 of the guide catheter shaft 22 comprises an actuation element 72 (also called a “pull wire”) which has its distal end at the distal end of the steerable section 68. Stated differently, the actuation element 72 can extend distally from the handle 20 through the guide catheter shaft 22 and have its distal end portion affixed to the guide catheter shaft 22 at or near the distal end of the guide catheter shaft 22. The proximal end of the actuation element 72 can extend into and can be secured to a retaining pin, such as by crimping the pin around the proximal end of the pull wire, which pin is disposed in a slot in a slide nut. The handle 20 includes an adjustment member, such as the illustrated rotatable knob 70, which in turn is operatively coupled to the slide nut. Rotating the knob 70 moves the slide nut axially and increases or decreases the tension in the actuation element 72, thereby adjusting the curvature of the steerable section 68 of the delivery apparatus 10. Further details on steering or flex mechanisms for the delivery apparatus can be found in U.S. Patent No. 9,339,384 and in International Publication No. WO 2022/046585, which are incorporated by reference herein. [0037] As shown in FIG. 2, the handle 20 can further include an adjustment mechanism 30 including an adjustment member, such as the illustrated rotatable knob 32, and a shaft 34 extending distally into a housing 36 of the handle 20. The adjustment mechanism 30 is configured to adjust the axial position of the intermediate shaft 26 relative to the guide catheter shaft 22. In some examples, an inner support 38 is mounted within the housing 36 on the intermediate shaft 26 and an inner shaft 40 (also referred to as a “slider” or “sliding member”) is mounted on the inner support 38. The inner shaft 40 can have a distal end portion with threads 42 which are threadedly coupled with the inner threads 33 of shaft 34. The inner shaft 40 can be coupled to the inner support 38 such that rotation of knob 32, and therefore shaft 34, causes the inner shaft 40 to move axially within the handle 20.

[0038] As depicted in FIG. 2, the inner shaft 40 further includes a proximal end portion 44 that mounts and interfaces with a locking mechanism 60, which is configured to retain (also referred to as “selectively couple” and/or “lock”) the position of the intermediate shaft 26 relative to the inner shaft 40. The locking mechanism 60 can include another adjustment member, configured as a rotatable lock knob 62 housing an inner nut 64 with inner threads that engage external threads of the proximal end portion 44 of the inner shaft 40.

[0039] To restrain movement of the intermediate shaft 26, the lock knob 62 is rotated, which in turn causes rotation of the inner nut 64. As a result, the inner nut 64 translates in the distal direction along the external threads on the proximal end portion 44 of the inner shaft 40. As the nut 64 is moved distally, additional components of the locking mechanism 60 are configured to Fictionally engage the intermediate shaft 26, thereby retaining the intermediate shaft 26 relative to the inner shaft 40. With the lock knob 62, in the locked position, rotation of the knob 32 causes the inner shaft 40 and the intermediate shaft 26 to move axially relative to the guide catheter shaft 22 (either in the proximal or distal direction, depending on the direction the knob 32 is rotated). In other words, rotation of the knob 32 results in translational movement of the sliding member and first shaft relative to the second shaft.

[0040] Rotating the lock knob 62 in the opposite direction from the locked position to the unlocked position allows axial and rotational movement of the intermediate shaft 26 relative to the inner shaft 40 and the proximal end portion of the handle 20. Further details on the adjustment mechanism 30 and locking mechanism 60 of the handle 20 can be found in U.S. Patent No. 9,339,384. [0041] FIG. 3 depicts an example of the inner shaft 40. As mentioned above, the inner shaft 40 can have a distal end portion with threads 42 which arc thrcadcdly coupled with the inner threads 33 of shaft 34 (FIG. 2) and a proximal end portion 44 that mounts and interfaces with the locking mechanism 60. The inner shaft can also comprise one or more features which interface with one or more of the removable clips described herein. For example, the inner shaft 40 may have an axially extending flat zone 46. The flat zone 46 may, for example, provide a mounting surface for the removable clips which can help to prevent the removable clip, for example removable clip 100, from moving relative to the inner shaft 40 in a circumferential direction. In some examples, the flat zone 46 may extend along the entire axial length of the inner shaft 40. In some examples, the flat zone 46 can extend along a portion of the axial length of the inner shaft 40. In some examples, when the inner shaft 40 is installed in the adjustment mechanism 30 there is a gap 39 between the flat zone 46 on the inner shaft 40 and the inner threads 33 of the shaft 34 (FIG. 2).

[0042] Additionally, the inner shaft 40 may have one or more elements on the exterior surface which can interface with corresponding elements on the interior surface of the inner cavity of the removable clips described below. In some examples, these elements can be included on a mounting portion 41. In some examples, the one or more elements on the exterior surface of the inner shaft 40 comprises one or more grooves. In the depicted example the inner shaft 40 comprises two grooves 48 which are sized and shaped to interface with corresponding protrusions, for example, protrusions 116 on the inner surface 114 of the inner cavity 110 of removable clip 100a, 100b (FIGS. 4A-4B) or protrusions 216 on the inner surface 214 of the inner cavity 210 of removable clip 200. In some examples, the outer surface of the inner shaft 40 may comprise protrusions and the inner surface of the removable clips may comprise groves. In some examples, the elements on the outer surface of the inner shaft 40 and inner surface of the removable clips may be other designs, for example, interlocking circumferential ridges, interlocking teeth, etc.

[0043] To implant a prosthetic valve (for example, prosthetic valve 12) in a native heart valve of the patient, the delivery apparatus 10 can be introduced into a vasculature of the patient. As the prosthetic valve 12 is guided through the aortic arch and into the ascending aorta, the curvature of the steerable section 68 can be adjusted to help guide or steer the prosthetic valve 12 through that portion of the vasculature. When navigating the prosthetic valve 12 through an arched region of the vasculature (for example, the aortic arch), the curvature of the steerable section 68 can be adjusted as discussed above, for example, by rotating the knob 70 to tension the actuation element 72.

[0044] Flexing the steerable section 68 of the guide catheter shaft 22 to adjust the curvature can, in some instances, result in the guide catheter shaft 22 axially foreshortening relative to the intermediate shaft 26. The delivery apparatus 10, and more specifically the removable clips described below, comprise features to assist the user in properly preparing the delivery apparatus such that there is pre-applied tension on the intermediate shaft 26, which results in compression between a distal end portion 66 of the guide catheter shaft 22 and a proximal end portion of the prosthetic valve 12. This pre-applied tension (and the resulting compression between the distal end portion 66 of the guide catheter shaft 22 and a proximal end portion of the prosthetic valve 12) helps to compensate for the axial foreshortening of the guide catheter shaft 22. These features can, for example, help to keep the distal end of the guide catheter shaft 22 and the proximal end of the prosthetic valve 12 in close proximity so that there is no gap or a minimal gap there between. Maintaining a distal end portion 66 of the guide catheter shaft 22 against or in close proximity to the proximal end of the prosthetic valve 12 can provide one or more advantages. For example, it can prevent the valve from moving proximally relative to the balloon 28. Additionally (or alternatively), it can provide a relatively smooth transition from the prosthetic valve to the guide catheter shaft, which enables it to pass with less friction through the patient’s vasculature.

[0045] The preparation of the delivery apparatus 10 can include a distal tensioning step during which tension is applied to the intermediate shaft 26 which results in compression between the distal end of the guide catheter shaft 22 and the proximal end of the prosthetic valve 12. This pre-applied compression can relax during the axially foreshortening of the guide catheter shaft 22 as it is adjusted to navigate the patient’s vasculature, as described above. As the compression is relaxed during the adjustment of the curvature the distal end of the guide catheter shaft 22 and the proximal end of the prosthetic valve 12 remain in close proximity so that there is no gap or a minimal gap there between.

[0046] A removable clip, such as the clips described below, can provide several advantages. Removable clips can provide an obvious visual reminder to assist the user in remembering to complete the distal tensioning step. Additionally, these removable clips physically cannot be removed until the distal tensioning step has been performed correctly, which helps to ensure uniformity in the preparation of the delivery apparatus 10. Furthermore, removable clips can provide symbolic instructions to indicate the proper steps. The removable nature of the clips described below mean that these instructions can be read and followed during preparation of the delivery apparatus 10 and then be removed prior to handing the delivery apparatus over to the surgeon carrying out the insertion procedure wherein the delivery apparatus is inserted into the patient’s vasculature. This has the advantage of minimizing potential confusion by the medical team during the procedure.

[0047] As described above, FIG. 2 is a cross-sectional view of an example of the proximal portion of the handle 20 with a removable clip 100 installed. As depicted, the removable clip 100 can be positioned around the inner shaft 40 and axially overlap the rotatable knob 32. As will be discussed in detail below, the removable clip 100 can have a ridge 102, a tongue 104, an alignment projection (which can also be referred to as a “lip”) 106, an inner cavity 110, and one or more tabs (which can also be referred to as “ears”) 108. The ridge 102 can extend radially outward from the inner shaft 40. In some examples, the removable clip 100 comprises a single unitary piece. In some examples, the removable clip 100 can comprise multiple components coupled to one another with adhesive (such as autoclave rated glue), or other fasteners (such as screws or rivets). In some examples, the removable clip comprises plastic such as Polypropylene (PP), polyethylene terephthalate (PET), Polyethylene (PE), etc. In some examples, the removable clip can comprise Acrylonitrile Butadiene Styrene (ABS). In some examples, the removable clip can comprise silicone. In other examples, the removable clip can comprise metal, composite, or another similar material.

[0048] FIGS. 4A-4B depict perspective views of a removable clip 100 with two exemplary configurations, removable clip 100a and removable clip 100b. As described above, the removable clip 100 comprises the tongue 104 and the alignment projection 106. The tongue 104 can be coupled to the ridge 102 and extends in a distal direction from the ridge 102 when the removable clip is installed on the inner shaft 40 of the handle 20. In some examples, the tongue can extend less than 0.25 inches in the distal direction. In some examples the tongue 104 can extend 0.186 to 0.202 inches in the distal direction. The proximal portion of the knob 32 has an inner diameter which defines a ledge 35 which can axially overlap with the tongue 104. In some examples, the tongue has a radially inward surface 103 that is flat and a radially outer surface 105 that is curved, for example, curved to match the curvature of the ledge 35. The flat radially inward surface 103 is sized and shaped to fit with the flat zone 46 on the inner shaft 40. In some examples, the tongue is a solid piece, comprising the radial area between radially inward surface 103 and radially outer surface 105. In some examples, it is made up of an upper portion 104a and a lower portion 104b which can be connected, for example by radially extending struts. [0049] The alignment projection 106 can be coupled to the ridge 102 at a position that is radially outward of the tongue 104. In some examples, the alignment projection 106 can be coupled to the distal end portion of the tabs 108. As depicted, the alignment projection 106 of removable clip 100a is curved to match the outer curvature of the knob 32 and the alignment projection 106 of removable clip 100b is flat. In the depicted example, the alignment projection 106 extends in the distal direction. When installed on the inner shaft 40, this alignment projection 106 can axially overlap the knob 32. As will be discussed in detail below, in some examples, the alignment projection 106 can comprise user instructions.

[0050] In some examples, the removable clip 100 can comprise two sidewalls 112, which are coupled to each other and can collectively be referred to as a clasp. In some examples, the sidewalls 112 can each form a part of a clasp which is a unitary construction defining a circumferential portion of an annular cylinder. In some examples the circumferential portion of the annular cylinder can extend anywhere from 180 degrees (that is a half of an annular cylinder) to 360 degrees (that is the ends of the sidewalls can abut each other) around a longitudinal axis 150. Regardless of their configuration, the sidewalls 112 can elastically deform at least to the diameter of the inner shaft 40, such that the clasp can be removed from the inner shaft 40. The removable clip 100 can also comprise an inner cavity 110 which is defined by the sidewalls 112 and is sized and shaped to receive the inner shaft 40, for example at the mounting portion 41 of the inner shaft 40. In the depicted example, the inner cavity 110 is a cylindrical inner cavity which defines a longitudinal axis 150.

[0051] An inner surface 114 of the inner cavity 110 (for example, an inner surface 114 of the sidewalls 112), may further comprise one or more protrusions 116 which can interface with corresponding grooves 48 on the inner shaft 40. In some examples, the outer surface of the inner shaft 40 may comprise protrusions and the inner surface 114 of the removable clip 100 may comprise groves. [0052] The removable clip 100 may also comprise one or more tabs 108 which can assist in installation and/or removal of the removable clip 100 from the inner shaft 40. In some examples the one or more tabs 108 comprises two tabs. In some examples, the tabs 108 allow the user to more easily grip the removable clip 100 for removal or installation. In in some examples, the tabs 108, can be pressed towards one another with the result that the sidewalls 112 flare radially outward and the inner cavity 110 expands to help facilitate removal of the removable clip 100 from the inner shaft 40.

[0053] FIGS. 5A-5C depict the distal tensioning step of the preparation of the delivery apparatus 10. During this step, tension is applied to the intermediate shaft 26 and compression is applied between the distal end portion 66 of the guide catheter shaft 22 and the proximal end of the prosthetic valve 12. In FIG. 5A, the delivery apparatus is in an initial state with the removable clip 100 installed and no distal compression applied between the distal end of the guide catheter shaft 22 and the proximal end of the prosthetic valve. In this initial state the rotatable knob 32 axially overlaps with the tongue 104 such that the removable clip 100 is captured and cannot be removed.

[0054] Between FIG. 5A and FIG. 5B, the knob 32 is rotated which results in the inner shaft 40 moving proximally, as detailed above. As mentioned above and described in detail below, the removable clip 100 can comprise one or more instruction symbols. In the example depicted in FIGS 5A-5B, the desired direction of rotation of the knob 32 is indicated by a series of chevrons 118 and the desired amount of rotation is achieved, and therefore the preselected compression is applied, when a line 120 is at the proximal end of the knob 32. When the line 120 has moved in the proximal direction so that it is adjacent to the proximal end of the knob 32, the removable clip 100 has moved proximally such that the ledge 35 of the knob 32 no longer axially overlaps tongue 104. Between FIG. 5B and FIG. 5C, the removable clip 100 is removed from the inner shaft 40, for example by pressing the two tabs 108 towards each other and pulling the removable clip 100 away from the inner shaft 40. FIG. 5C depicts the handle with the removable clip 100 removed and the distal tensioning step complete. A preselected amount of tension has been applied to the intermediate shaft 26 and the corresponding compression has been applied between the distal end of the guide catheter shaft 22 and the proximal end of the prosthetic valve 12. [0055] FIGS. 6 A and 6B schematically depict the in vivo positions of the distal end portion 66 of the guide catheter shaft 22 as the delivery apparatus 10 traverses the patient’s vasculature on the way to the aortic annulus 90. As depicted in FIG. 6A because preparation of the delivery apparatus 10 includes the distal tensioning step there is initially no gap between the distal end portion 66 of the guide catheter shaft 22 and the proximal end of the prosthetic valve 12. As depicted in FIG. 6B after the guide catheter shaft 22 has curved around the aortic arch, there is still no gap because the compression of the guide catheter shaft 22 has relaxed, keeping the distal end portion 66 of the guide catheter shaft 22 adjacent to the proximal end of the prosthetic valve 12.

[0056] FIG. 7 depicts a removable clip 200 according to another example. The removable clip 200 should be understood to be used with a delivery apparatus such as the delivery apparatus 10 described above. The removable clip 200 can comprise a ridge 202, an elongate tongue 204, and a clasp 212. In some examples, the removable clip 200 comprises a single unitary piece. In some examples, the removable clip 200 can comprise multiple components coupled to one another with adhesive (such as autoclave rated glue), or other fasteners (such as screws or rivets). In some examples the clasp 212 can comprise a circumferential portion of an annular cylinder configured to engage the inner shaft 40. In some examples, when installed around the inner shaft 40, the annular cylinder can extend circumferentially anywhere from 180 to 360 degrees around a longitudinal axis 250. In other words, the interior cavity 210 of the clasp 212 is sized and shaped to receive the inner shaft 40, for example at the mounting portion 41 of the inner shaft 40. Regardless of its configuration, the opening of the clasp 212 can elastically deform at least to the diameter of the inner shaft 40, such that the clasp 212 can be removed from the inner shaft 40. In the depicted example, the inner cavity 210 is a cylindrical inner cavity which defines the longitudinal axis 250. An inner surface 214 of the inner cavity 210 (for example, an inner surface 214 of the clasp 212), may further comprise one or more protrusions 216 which can interface with corresponding grooves 48 on the inner shaft 40. In some examples, the outer surface of the inner shaft 40 may comprise protrusions and the inner surface 214 of the removable clip 200 may comprise groves.

[0057] In some examples, ridge 202 can be coupled to the clasp 212. The ridge 202 can, for example, assist in installation and/or removal of the removable clip from the inner shaft 40. In some examples, the ridge 202 can be omitted or another structure such as a suture loop, pull tab, etc. can be substituted.

[0058] The elongate tongue 204 is coupled to the clasp 212 extends in the distal direction. In some examples the elongate tongue 204 can extend 0.5 to 1.5 inches in the distal direction. The elongate tongue 204 may have a radially inward surface 203 and a radially outward surface 205. The radially inward surface 203 may be flat and may be sized and shaped to interface with the axially extending flat zone 46 of the inner shaft 40. For example, to form a cylinder with the flat portion of the axially extending flat zone 46 of the inner shaft 40. In other words, when the removable clip 200 is initially installed on the inner shaft 40 the elongate tongue 204 can extend into the gap 39 between the flat zone 46 on the inner shaft 40 and the inner threads 33 of the shaft 34. This means that the elongate tongue 204 can extend distally into the shaft 34 of the knob 32 without interfering with the rotation of the knob 32.

[0059] FIGS. 8A-8B depict the distal tensioning step of the preparation of the delivery apparatus 10 with the removable clip 200. As described above, during this step, compression is applied between the distal end portion 66 of the guide catheter shaft 22 and the proximal end of the prosthetic valve 12. In FIG. 8A, the delivery apparatus is in its initial state with the removable clip 200 installed with the elongate tongue 204 axially overlapped by the shaft 34 and knob 32. There is no distal compression applied between the distal end portion 66 of the guide catheter shaft 22 and the proximal end of the prosthetic valve 12. Between FIG. 8A and FIG. 8B, the knob 32 is rotated resulting in the inner shaft 40 moving proximally, as detailed above. [0060] In FIG. 8B, rotation of the knob 32 has moved the inner shaft 40 and the removable clip 200 proximally such that elongate tongue 204 is no longer axially overlapped by the knob 32 (or the shaft 34). The removable clip 200 can then be removed from the inner shaft 40, for example by gripping and applying a radially outward force to the ridge 202 and pulling the removable clip 200 away from the inner shaft 40. The handle with the removable clip 200 removed and the distal tensioning step complete can be seen in FIG. 5C. Upon completion of this step, a preselected amount of tension has been applied to the intermediate shaft 26 and corresponding compression has been applied between the distal end of the guide catheter shaft 22 and the proximal end of the prosthetic valve 12.

[0061] In all of the examples of delivery apparatuses above, after the valve 12 has been navigated to the aortic annulus, additional steps can be taken to position the prosthetic valve 12. For example, the locking mechanism 60 can be placed in the unlocked position and the guide catheter shaft 22 can be retracted relative to the intermediate shaft 26. This means that the distal end portion 66 of the guide catheter shaft 22 no longer abuts or is adjacent to the proximal end of the prosthetic valve 12. The locking mechanism 60 can then be placed back in the locked position and the knob 32 can be rotated to cause the intermediate shaft 26 to move axially relative to the guide catheter shaft 22 and allow the user to position the prosthetic valve 12 relative to the desired deployment location as described above. Additional information regarding positioning and/or expanding the prosthetic valve 12 can be found in U.S. Patent No. 9,339,384 and in International Publication No. WO 2022/046585.

[0062] FIGS . 9A-9E depict several examples of user instructions which can be included on the removable clips. In the depicted examples the user instructions are markings which are printed on the alignment projection 106 of the removable clip 100. But it should be understood that user instructions can also be included on the other removable clips described herein. The instructions can comprise writing, symbols, and/or other indicia. As introduced above, in some examples, one or more chevrons 118 can indicate the direction of rotation of the knob 32 and, in some examples, a line 120 indicates the axial distance the clip needs to travel before it can be removed (for example, when the line 120 lines up with the proximal end of the knob 32, the clip is ready to be removed). In some examples, a lock symbol 122 directs the user to lock the locking mechanism 60 prior to turning the knob 32. In some examples, one or more arrows, such as arrow 124, pointing in a proximal direction can indicate the direction that the clip is to be traversed prior to removal. In some examples, any of the above symbols or other additional symbols can be included alone or in combination. In some examples the instructions can be engraved, embossed, etc.

[0063] The operation of the removable clips, as discussed above, keeps the distal end of the guide catheter shaft 22 and the proximal end of the prosthetic valve 12 in close proximity so that no gap (or a minimal gap) forms as the delivery apparatus 10 traverses the patient’s vasculature on the way to the aortic annulus 90. Maintaining the distal end portion 66 of the guide catheter shaft 22 against or in close proximity to the proximal end of the prosthetic valve 12 can prevent the valve from moving proximally relative to the balloon. Additionally (or alternatively), it can provide a relatively smooth transition from the prosthetic valve to the guide catheter shaft, which enables it to pass with less friction through the patient’s vasculature. Furthermore, this device retains the functionality of adjusting the axial position of the intermediate shaft 26 relative to the guide catheter shaft 22 to position the prosthetic device relative to the desired deployment location. For example, a user can rotate the knob 32 with the locking mechanism 60 in the locked position and/or axially move the intermediate shaft 26 relative to the guide catheter shaft 22 with the locking mechanism 60 in the unlocked position.

[0064] FIG. 10 shows a prosthetic heart valve 400, which can be one specific example of the prosthetic valve 12 described above. As shown, the prosthetic heart valve 400 comprises a frame, or stent, 402 and a leaflet structure 404 supported by the frame. In some examples, the prosthetic heart valve 400 is adapted to be implanted in the native aortic valve and can be implanted in the body using, for example, the delivery apparatus 10 described above. The prosthetic valve 400 can also be implanted within the body using any of the other delivery apparatuses described herein.

[0065] In some examples, the frame 402 comprises a plastically expandable material, which can be metal alloys, polymers, or combinations thereof. Example metal alloys can comprise one or more of the following: nickel, cobalt, chromium, molybdenum, titanium, or other biocompatible metal. In some examples, the frame 402 can comprise stainless steel. In some examples, the frame 402 can comprise cobalt-chromium. In some examples, the frame 402 can comprise nickel-cobalt-chromium. In some examples, the frame 402 comprises a nickel-cobalt-chromium- molybdenum alloy, such as MP35N™ (tradename of SPS Technologies), which is equivalent to UNS R3OO35 (covered by ASTM F562-02). MP35N™/UNS R3OO35 comprises 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum, by weight. Additional details of the prosthetic valve 400 can be found in U.S. Patent No. 9,393,110, which is incorporated by reference herein in its entirety. Other exemplary prosthetic valves that can be used with the technology disclosed herein can be found in International Publication No. WO 2022/046585, which is incorporated by reference herein in its entirety.

Delivery Techniques

[0066] For implanting a prosthetic valve within the native aortic valve via a transfemoral delivery approach, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus. The prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral artery and are advanced into and through the descending aorta, around the aortic arch, and through the ascending aorta. The prosthetic valve is positioned within the native aortic valve and radially expanded (for example, by inflating a balloon, actuating one or more actuators of the delivery apparatus, or deploying the prosthetic valve from a sheath to allow the prosthetic valve to self-expand). Alternatively, a prosthetic valve can be implanted within the native aortic valve in a transapical procedure, whereby the prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart and the prosthetic valve is positioned within the native aortic valve. Alternatively, in a transaortic procedure, a prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the aorta through a surgical incision in the ascending aorta, such as through a partial J-stemotomy or right parasternal mini-thoracotomy, and then advanced through the ascending aorta toward the native aortic valve.

[0067] For implanting a prosthetic valve within the native mitral valve via a transseptal delivery approach, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus. The prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral vein and are advanced into and through the inferior vena cava, into the right atrium, across the atrial septum (through a puncture made in the atrial septum), into the left atrium, and toward the native mitral valve. Alternatively, a prosthetic valve can be implanted within the native mitral valve in a transapical procedure, whereby the prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart and the prosthetic valve is positioned within the native mitral valve.

[0068] For implanting a prosthetic valve within the native tricuspid valve, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus. The prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral vein and are advanced into and through the inferior vena cava, and into the right atrium, and the prosthetic valve is positioned within the native tricuspid valve. A similar approach can be used for implanting the prosthetic valve within the native pulmonary valve or the pulmonary artery, except that the prosthetic valve is advanced through the native tricuspid valve into the right ventricle and toward the pulmonary valve/pulmonary artery.

[0069] Another delivery approach is a transatrial approach whereby a prosthetic valve (on the distal end portion of the delivery apparatus) is inserted through an incision in the chest and an incision made through an atrial wall (of the right or left atrium) for accessing any of the native heart valves. Atrial delivery can also be made intravascularly, such as from a pulmonary vein. Still another delivery approach is a trans ventricular approach whereby a prosthetic valve (on the distal end portion of the delivery apparatus) is inserted through an incision in the chest and an incision made through the wall of the right ventricle (typically at or near the base of the heart) for implanting the prosthetic valve within the native tricuspid valve, the native pulmonary valve, or the pulmonary artery.

[0070] In all delivery approaches, the delivery apparatus can be advanced over a guidewire previously inserted into a patient’s vasculature. Moreover, the disclosed delivery approaches are not intended to be limited. Any of the prosthetic valves disclosed herein can be implanted using any of various delivery procedures and delivery devices known in the art.

[0071] Any of the systems, devices, apparatuses, etc. herein can be sterilized (for example, with heat/thermal, pressure, steam, radiation, and/or chemicals, etc.) to ensure they arc safe for use with patients, and any of the methods herein can include sterilization of the associated system, device, apparatus, etc. as one of the steps of the method. Examples of heat/thermal sterilization include steam sterilization and autoclaving. Examples of radiation for use in sterilization include, without limitation, gamma radiation, ultra-violet radiation, and electron beam.

Examples of chemicals for use in sterilization include, without limitation, ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde, and glutaraldehyde. Sterilization with hydrogen peroxide may be accomplished using hydrogen peroxide plasma, for example. [0072] The treatment techniques, methods, steps, etc. described or suggested herein or in references incorporated herein can be performed on a living animal or on a non-living simulation, such as on a cadaver, cadaver heart, anthropomorphic ghost, simulator (for example, with the body parts, tissue, etc. being simulated), etc.

Additional Examples of the Disclosed Technology

[0073] In view of the above-described implementations of the disclosed subject matter, this application discloses the additional examples enumerated below. It should be noted that one feature of an example in isolation or more than one feature of the example taken in combination and, optionally, in combination with one or more features of one or more further examples are further examples also falling within the disclosure of this application. [0074] Example 1 . A removable clip for a delivery apparatus, the removable clip comprising: a clasp; an inner cavity formed by the clasp, the inner cavity defining a longitudinal axis, a ridge coupled to the clasp and extending radially outward from the longitudinal axis; a tongue coupled to the clasp and extending in a distal direction.

[0075] Example 2. The removable clip of any example herein, particularly example 1, further comprising an alignment projection which is coupled to the ridge radially outward from the tongue and extends in a distal direction.

[0076] Example 3. The removable clip of any example herein, particularly example 2, further comprising user instructions printed on the alignment projection.

[0077] Example 4. The removable clip of any example herein, particularly any one of examples 1-3, further comprising one or more tabs coupled to the ridge and the clasp.

[0078] Example 5. The removable clip of any example herein, particularly example 4, wherein the one or more tabs comprises two tabs wherein pressing the tabs results in the clasp expanding radially outward.

[0079] Example 6. The removable clip of any example herein, particularly any one of examples 1-5, wherein the tongue extends less than 0.25 inches in the distal direction.

[0080] Example 7. The removable clip of any example herein, particularly any one of examples 1-3 wherein the tongue extends between 0.5- 1.5 inches in the distal direction.

[0081] Example 8. The removable clip of any example herein, particularly any one of examples 1-7, wherein the clasp defines a circumferential portion of an annular cylinder.

[0082] Example 9. The removable clip of any example herein, particularly any one of examples 1-8, further comprising a plurality of protrusions on an inner surface of the clasp.

[0083] Example 10. A delivery apparatus for delivering a medical implant, comprising the removable clip of any one of examples 1-9, and further comprising: a first shaft having a proximal end portion and a distal end portion; a second shaft, wherein the second shaft extends over the first shaft and has a proximal end portion and a distal end portion; and a handle portion comprising: a sliding member coupled to the proximal end portion of the first shaft; and a rotatable knob that is rotatably coupled to the proximal end portion of the second shaft and operatively coupled to the sliding member so rotation of the rotatable knob relative to the first shaft results in translational movement of the sliding member and first shaft relative to the second shaft; wherein the clasp is disposed around a proximal end portion of the sliding member. [0084] Example 11 . The delivery apparatus of any example herein, particularly example 10 wherein the sliding member is selectively coupled to the proximal end portion of the first shaft. [0085] Example 12. The delivery apparatus of any example herein, particularly example 11, further comprising a balloon disposed on the distal end portion of the first shaft and an expandable prosthetic medical device disposed around the balloon.

[0086] Example 13. The delivery apparatus of any example herein, particularly example 12, wherein rotation of the rotatable knob relative to the first shaft results in compression between a distal end portion of the second shaft and a proximal end portion of the expandable prosthetic medical device.

[0087] Example 14. The delivery apparatus of any example herein, particularly any one of examples 10-13, wherein the tongue is sized and shaped to extend into a gap between the sliding member and the rotatable knob.

[0088] Example 15. The delivery apparatus of any example herein, particularly any one of examples 10-14, further comprising one or more grooves on an exterior surface of the sliding member.

[0089] Example 16. A method of preparing a delivery apparatus for insertion into a patient’s vasculature, the method comprising: a delivery apparatus with a removable clip installed on a sliding member wherein the sliding member is selectively coupled to a proximal end portion of a first shaft; rotating a rotatable knob wherein the rotatable knob is rotatably coupled to the proximal end portion of a second shaft and operatively coupled to the sliding member so rotation of the rotatable knob relative to the first shaft results in translational movement of the sliding member and first shaft relative to the second shaft and wherein translational movement of the first shaft relative to the second shaft results in compression of a distal end of the second shaft against a proximal end of a medical implant disposed around a distal end of the first shaft; compressing the distal end of the second shaft against a proximal end of a medical implant to a preselected amount of compression; and removing a removable clip from the sliding member when a preselected amount of compression has been applied.

[0090] Example 17. The method of any example herein, particularly example 16, further comprising prior to removing the removable clip, pressing two tabs toward one another which resulting in sidewalls flaring radially outward. [0091] Example 18. The method of any example herein, particularly any one of example 16-17, wherein the removable clip comprises a marking indicating when the preselected amount of compression has been applied and the step of rotating a rotatable knob comprises rotating the rotatable knob until the marking is at a proximal end of the rotatable knob.

[0092] Example 19. The method of any example herein, particularly any one of examples 16- 18, further comprising introducing the delivery apparatus into a patient’s vasculature after removing the removable clip.

[0093] Example 20. A removable clip for a delivery apparatus, the removable clip comprising: a clasp, wherein the clasp comprises an inner cavity and the inner cavity defines a longitudinal axis; a tongue coupled to the clasp and extending in a distal direction.

[0094] Example 21. A delivery apparatus for delivering a medical implant, comprising the removable clip of any example herein, particularly example 20, and further comprising: a first shaft having a proximal end portion and a distal end portion; a second shaft, wherein the second shaft extends over the first shaft and has a proximal end portion and a distal end portion; and a handle portion comprising: a sliding member coupled to the proximal end portion of the first shaft; and a rotatable knob that is rotatably coupled to the proximal end portion of the second shaft and operatively coupled to the sliding member so rotation of the rotatable knob relative to the first shaft results in translational movement of the sliding member and first shaft relative to the second shaft; wherein the clasp is disposed around a proximal end portion of the sliding member and the knob axially overlaps the tongue.

[0095] The features described herein with regal'd to any example can be combined with other features described in any one or more of the other examples, unless otherwise stated. For example, any one or more of the features of one removable clip can be combined with any one or more features of another removable clip. As another example, any one or more features of one delivery apparatus can be combined with any one or more features of another delivery apparatus. [0096] In view of the many possible ways in which the principles of the disclosure may be applied, it should be recognized that the illustrated configurations depict examples of the disclosed technology and should not be taken as limiting the scope of the disclosure nor the claims. Rather, the scope of the claimed subject matter is defined by the following claims and their equivalents.

Claims

CLAIMS:

1. A removable clip for a delivery apparatus, the removable clip comprising: a clasp; an inner cavity formed by the clasp, the inner cavity defining a longitudinal axis, a ridge coupled to the clasp and extending radially outward from the longitudinal axis; a tongue coupled to the clasp and extending in a distal direction.

2. The removable clip of claim 1, further comprising an alignment projection which is coupled to the ridge radially outward from the tongue and extends in a distal direction.

3. The removable clip of claim 2, further comprising user instructions printed on the alignment projection.

4. The removable clip of any one of claims 1-3, further comprising one or more tabs coupled to the ridge and the clasp.

5. The removable clip of claim 4, wherein the one or more tabs comprises two tabs wherein pressing the tabs results in the clasp expanding radially outward.

6. The removable clip of any one of claims 1-5, wherein the tongue extends less than 0.25 inches in the distal direction.

7. The removable clip of any one of claims 1-3 wherein the tongue extends between 0.5- 1.5 inches in the distal direction.

8. The removable clip of any one of claims 1-7, wherein the clasp defines a circumferential portion of an annular cylinder.

9. The removable clip of any one of claims 1-8, further comprising a plurality of protrusions on an inner surface of the clasp.

10. A delivery apparatus for delivering a medical implant, comprising the removable clip of any one of claims 1-9, and further comprising: a first shaft having a proximal end portion and a distal end portion; a second shaft, wherein the second shaft extends over the first shaft and has a proximal end portion and a distal end portion; and a handle portion comprising: a sliding member coupled to the proximal end portion of the first shaft; and a rotatable knob that is rotatably coupled to the proximal end portion of the second shaft and operatively coupled to the sliding member so rotation of the rotatable knob relative to the first shaft results in translational movement of the sliding member and first shaft relative to the second shaft; wherein the clasp is disposed around a proximal end portion of the sliding member.

11. The delivery apparatus of claim 10 wherein the sliding member is selectively coupled to the proximal end portion of the first shaft.

12. The delivery apparatus of claim 11, further comprising a balloon disposed on the distal end portion of the first shaft and an expandable prosthetic medical device disposed around the balloon.

13. The delivery apparatus of claim 12, wherein rotation of the rotatable knob relative to the first shaft results in compression between a distal end portion of the second shaft and a proximal end portion of the expandable prosthetic medical device.

14. The delivery apparatus of any one of claims 10-13, wherein the tongue is sized and shaped to extend into a gap between the sliding member and the rotatable knob.

15. The delivery apparatus of any one of claims 10-14, further comprising one or more grooves on an exterior surface of the sliding member.

16. A method of preparing a delivery apparatus for insertion into a patient’s vasculature, the method comprising: a delivery apparatus with a removable clip installed on a sliding member wherein the sliding member is selectively coupled to a proximal end portion of a first shaft; rotating a rotatable knob wherein the rotatable knob is rotatably coupled to the proximal end portion of a second shaft and operatively coupled to the sliding member so rotation of the rotatable knob relative to the first shaft results in translational movement of the sliding member and first shaft relative to the second shaft and wherein translational movement of the first shaft relative to the second shaft results in compression of a distal end of the second shaft against a proximal end of a medical implant disposed around a distal end of the first shaft; compressing the distal end of the second shaft against a proximal end of a medical implant to a preselected amount of compression; and removing a removable clip from the sliding member when a preselected amount of compression has been applied.

17. The method of claim 16, further comprising prior to removing the removable clip, pressing two tabs toward one another which resulting in sidewalls flaring radially outward.

18. The method of any one of claims 16-17, wherein the removable clip comprises a marking indicating when the preselected amount of compression has been applied and the step of rotating a rotatable knob comprises rotating the rotatable knob until the marking is at a proximal end of the rotatable knob.

19. The method of any one of claims 16-18, further comprising introducing the delivery apparatus into a patient’s vasculature after removing the removable clip.

20. A removable clip for a delivery apparatus, the removable clip comprising: a clasp, wherein the clasp comprises an inner cavity and the inner cavity defines a longitudinal axis; a tongue coupled to the clasp and extending in a distal direction.

21 . A delivery apparatus for delivering a medical implant, comprising the removable clip of claim 20, and further comprising: a first shaft having a proximal end portion and a distal end portion; a second shaft, wherein the second shaft extends over the first shaft and has a proximal end portion and a distal end portion; and a handle portion comprising: a sliding member coupled to the proximal end portion of the first shaft; and a rotatable knob that is rotatably coupled to the proximal end portion of the second shaft and operatively coupled to the sliding member so rotation of the rotatable knob relative to the first shaft results in translational movement of the sliding member and first shaft relative to the second shaft; wherein the clasp is disposed around a proximal end portion of the sliding member and the knob axially overlaps the tongue.