Handle assembly and delivery device

Abstract

The utility model relates to a handle assembly and a delivery device. A handle assembly includes a first component having a male connection portion, the male connection portion including a body having a pin extending radially outward from the body. The handle assembly also includes a second component having a female connection portion configured to receive the male connection portion. The female connection portion has an inner surface defining an inner bore, a slot extending along the inner surface, and a retention portion connected to the slot and configured to receive the pin. The first member and the second member are movable between a locked configuration and a released configuration by inserting the body into the bore and rotating the male connection portion relative to the female connection portion less than a circle about an axial axis of the body. The pin is located within the retaining portion in the locked configuration and within the slot in the released configuration.

Description

[0001] This application is a divisional application. The application date of the original application is April 13, 2023, the application number is 2023208215932, and the name of the invention is “A handle assembly for a delivery device configured to deliver a prosthetic implant.”

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS

[0003] This application claims the benefit of U.S. Provisional Application No. 63 / 362,996, filed on April 14, 2022, which is incorporated herein by reference. Technical Field

[0004] The present disclosure is directed to examples of delivery devices and associated handle assemblies for delivering a prosthetic implant into a patient. Background Art

[0005] Prosthetic valves can be used to treat heart valve disease. The function of natural heart valves (e.g., aortic, pulmonary, tricuspid, and mitral valves) is to prevent regurgitation or backflow while allowing forward flow. These heart valves may become less effective due to congenital diseases, inflammatory processes, infectious conditions, etc. Such conditions can eventually lead to severe cardiovascular damage or death. For many years, doctors have tried to treat such diseases by surgically repairing or replacing the valves during open-heart surgery.

[0006] Transcatheter techniques that use a catheter to introduce and implant a prosthetic heart valve in a less invasive manner than open-heart surgery can reduce complications associated with open-heart surgery. In this technology, a prosthetic valve can be mounted in a compressed state on the end portion of a catheter and advanced through the patient's blood vessels until the valve reaches the implantation site. The valve at the tip of the catheter can then be expanded to its functional size at the site of the defective natural valve, for example by inflating a balloon on which the valve is mounted, or, for example, the valve can have an elastic self-expanding stent or frame that expands the valve to its functional size when advanced from a delivery sheath at the distal end of the catheter. Optionally, the valve can have a balloon-expandable, self-expanding, mechanically expandable frame, and / or a frame that is expandable in multiple ways or in combination.

[0007] In some cases, a transcatheter heart valve (THV) may be appropriately sized to be placed inside a particular native valve (e.g., a native aortic valve). As a result, the THV may not be suitable for implantation at the site of another native valve (e.g., a native mitral valve) and / or in patients with larger native valves. Additionally or alternatively, the native tissue at the implantation site may not provide sufficient structure to secure the THV in place relative to the native tissue.

[0008] In some cases, the docking device can be implanted first within the native valve and can be configured to receive the THV and secure (e.g., anchor) the THV at a desired location within the native valve. For example, the docking device can form a more circular and / or more stable anchoring site at the native valve annulus into which the THV can be expanded and implanted. A transcatheter delivery device can be used to deliver the docking device to the implantation site. In some cases, the docking device can be arranged within the delivery device, coaxial with additional components of the delivery device.

[0009] Operating a delivery device for implanting a THV and / or docking device involves complex steps and requires specialized skills.Therefore, there is a need for improved transcatheter delivery devices to simplify their operation. Utility Model Content

[0010] The present disclosure relates to devices and related methods for treating valvular regurgitation and / or other valvular problems. In particular, the present disclosure relates to a delivery device configured to deliver a prosthetic implant such as a THV and / or a docking device, and a method of implanting the prosthetic implant.

[0011] According to some examples, a handle assembly for a delivery device configured to deliver a prosthetic implant may include a first component having a male connection portion. The male connection portion may include a body having a pin extending radially outward from the body. The handle assembly may also include a second component having a female connection portion, the female connection portion being configured to receive the male connection portion of the first component. The female connection portion may have an inner surface defining an inner hole, a groove extending along the inner surface, and a retaining portion connected to the groove and configured to receive the pin. The first component and the second component may be movable between a locked configuration and a released configuration by inserting the body into the inner hole and rotating the male connection portion relative to the female connection portion about the axial axis of the body less than one revolution. In the locked configuration, the pin may be located in the retaining portion, and the groove may be configured to prevent the male connection portion from rotating relative to the female connection portion. In the released configuration, the pin may be located in the groove.

[0012] According to some examples, a handle assembly for a delivery device configured to deliver a prosthetic implant may include a first component having a female connection portion. The female connection portion may have an inner surface defining an inner hole and a pin extending radially inward from the inner surface. The handle assembly may also include a second component having a male connection portion configured to be inserted into the inner hole of the female connection portion. The male connection portion may include an outer surface, a groove extending along the outer surface, and a retaining portion connected to the groove and configured to receive the pin. The first component and the second component may be movable between a locked configuration and a released configuration by inserting the male connection portion into the inner hole and rotating the male connection portion relative to the female connection portion around the axial axis of the inner hole less than one circle. In the locked configuration, the pin may be located in the retaining portion, and the groove may be configured to prevent the male connection portion from rotating relative to the female connection portion. In the released configuration, the pin may be located in the groove.

[0013] According to some examples, a handle assembly for a delivery device configured to deliver a prosthetic implant may include: a suture lock configured to be connected to a release suture, the release suture being tied to the prosthetic implant; and an adapter having a lumen and an end portion, the lumen configured for the release suture to extend through, the end portion configured to be releasably connected to a connecting portion of the suture lock via a locking and release mechanism. The locking and release mechanism may include a nail and a slot configured to receive the nail. The slot may include a deflectable portion and a retaining portion connected to the deflectable portion. The retaining portion may be configured to retain the nail. The deflectable portion may have a smaller diameter than the nail. Rotation of the suture lock relative to the adapter in a first direction may be configured to move the nail through the deflectable portion and lock into the retaining portion, so that the deflectable portion inhibits the nail from moving out of the retaining portion. Rotation of the suture lock relative to the adapter in a second direction opposite to the first direction may be configured to move the nail out of the retaining portion through the deflectable portion.

[0014] According to certain examples, a handle assembly for a delivery device configured to deliver a prosthetic implant may include: a suture lock configured to be connected to a release suture, the release suture being tied to the prosthetic implant; and an adapter having a lumen and an end portion, the lumen configured for the release suture to extend through, the end portion configured to be releasably connected to a connecting portion of the suture lock via a locking and release mechanism. The connecting portion of the suture lock and the end portion of the adapter may be coaxial around an axial axis when connected. The locking and release mechanism may include a nail and a slot configured to receive the nail. The nail may be movable between a compressed state and an expanded state, and the nail may be biased toward the expanded state. The slot may include a track portion and a retaining portion connected to the track portion. The retaining portion may be configured to retain the nail in the expanded state. The track portion may be configured to receive the nail in the compressed state and may have a smaller diameter than the nail in the expanded state. Rotation of the suture lock relative to the adapter in a first direction can be configured to move a staple in the compressed state through the track portion and into the retaining portion such that the staple is locked therein in the expanded state and the track portion inhibits the staple from being removed from the retaining portion. Rotation of the suture lock relative to the adapter in a second direction opposite to the first direction can be configured to move the staple from the expanded state to the compressed state and remove the staple from the retaining portion through the track portion.

[0015] According to certain examples, a handle assembly for a delivery device configured to deliver a prosthetic implant may include: a suture lock configured to be connected to a release suture, the release suture being tied to the prosthetic implant; and an adapter having a lumen and an end portion, the lumen being configured for the release suture to extend through, the end portion being configured to be releasably connected to a connecting portion of the suture lock via a locking and release mechanism. The connecting portion of the suture lock and the end portion of the adapter may be coaxial around an axial axis when connected. The locking and release mechanism may include a nail and a slot configured to receive the nail. The slot may include an axial portion extending parallel to the axial axis and a circumferential portion connected to the axial portion and extending circumferentially around the axial axis. The locking and release mechanism may also include a retaining portion connected to an end of the circumferential portion and configured to retain the nail. The retaining portion may have a larger diameter than the circumferential portion. Rotation of the suture lock relative to the adapter in a first direction can be configured to cause the staple to move through the circumferential portion and lock into the retaining portion such that the circumferential portion inhibits the staple from being removed from the retaining portion. Rotation of the suture lock relative to the adapter in a second direction opposite to the first direction can be configured to cause the staple to move from the retaining portion through the circumferential portion.

[0016] According to some examples, a handle assembly for a delivery device configured to deliver a prosthetic implant may include: a suture lock configured to be connected to a release suture, the release suture being tied to the prosthetic implant; and an adapter having a lumen and an end portion, the lumen configured for the release suture to extend through, the end portion configured to be releasably connected to a connecting portion of the suture lock via a locking and release mechanism. The connecting portion of the suture lock and the end portion of the adapter may be coaxial around an axial axis when connected. The locking and release mechanism may include a first locking mechanism and a second locking mechanism. The first locking mechanism may include a first nail and a first slot configured to receive the first nail. When the first nail is received in a circumferential portion of the first slot, the suture lock may be configured to be rotatable but not axially movable relative to the adapter. The second locking mechanism may include a second nail and a second slot configured to receive the second nail. The second slot may extend circumferentially around the axial axis. A radially recessed stop may be connected to the second slot and configured to retain the second nail. When the first staple is received within the circumferential portion of the first slot, rotation of the suture lock relative to the adapter in a first direction can be configured to move the second staple through the second slot until the second staple snaps into the radially recessed stop such that the second slot inhibits the second staple from moving out of the radially recessed stop. Rotation of the suture lock relative to the adapter in a second direction opposite to the first direction can be configured to move the second staple out of the radially recessed stop through the second slot.

[0017] Certain examples of the present disclosure also relate to a delivery device configured to deliver a prosthetic implant. The delivery device may include any of the above-described handle assemblies and a delivery sheath extending distally from the handle assembly.

[0018] Certain examples of the present disclosure also relate to a method for implanting a prosthetic implant. The method may include assembling any of the above-described handle assemblies. The assembling may include rotating the suture lock relative to the adapter in the first direction to connect the suture lock to the adapter.

[0019] The foregoing and other objects, features and advantages of the presently disclosed technology will become more apparent from the following detailed description made with reference to the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] Figure 1 A docking device delivery apparatus is schematically shown for implanting a docking device for a prosthetic heart valve at a patient's mitral valve according to one example.

[0021] Figure 2A Schematic illustration of a fully implanted mitral valve in a patient after the docking device delivery apparatus has been removed from the patient. Figure 1 Docking device.

[0022] Figure 2B A prosthetic heart valve delivery device according to one example is schematically shown, wherein the prosthetic heart valve delivery device implants a prosthetic heart valve at the mitral valve of a patient. Figure 2A in the docking device.

[0023] Figure 3 is a side perspective view of a docking device in a spiral configuration according to one example.

[0024] Figure 3A According to an example, the image is taken along line 3A-3A. Figure 3 Cross-sectional view of the docking device.

[0025] Figure 3B is along with Figure 3A A cross-sectional view of the docking device taken along the same line as in Figure 3B In the embodiment, the docking device is in a substantially straight delivery configuration.

[0026] Figure 3C According to another example, the image is taken along line 3A-3A. Figure 3 Cross-sectional view of the docking device.

[0027] Figure 3D is along with Figure 3C A cross-sectional view of the docking device taken along the same line as in Figure 3D In the embodiment, the docking device is in a substantially straight delivery configuration.

[0028] Figure 4 is a side view of an exemplary delivery apparatus for a docking device, the delivery apparatus comprising a handle assembly and an outer shaft extending distally from the handle assembly.

[0029] Figure 5 yes Figure 4 Side view of a hub assembly of a handle assembly of a delivery device.

[0030] Figure 6 yes Figure 4 A perspective view of a distal portion of a delivery device of FIG. 1 , showing an exemplary docking device deployed from an outer shaft of the delivery device and covered by a sleeve shaft of the delivery device.

[0031] Figure 7 yes Figure 4 10 is deployed from an outer shaft of the delivery device with the sleeve shaft removed from the docking device.

[0032] Fig. 8A A portion of a handle assembly for a delivery device including a suture lock and a sleeve handle is shown according to one example.

[0033] Figure 8B It is disconnected from the branch of the handle assembly Fig. 8A Perspective view of a suture lock.

[0034] Figure 8C yes Fig. 8A Exploded view of the suture lock.

[0035] Fig. 9A Includes a flushing port at the proximal end of the suture lock Figures 8A-8C Side view of a suture lock.

[0036] Fig. 9B yes Figures 8A-8C A perspective view of a detail portion of a suture lock showing the release knob and internal release lever.

[0037] Fig. 9C yes Fig. 9B Side cross-sectional view of the release lever of the suture lock.

[0038] Fig.9D yes Figure 9B-9C A perspective view of the release lever.

[0039] Fig.9E yes Figures 9B-9D Detailed cross-sectional view of the suture-cutting portion of the release lever.

[0040] Fig. 10A A suture lock is shown coupled to an adapter of a handle assembly according to one example.

[0041] Fig. 10B Shows relative to Fig. 10A The adapter portion rotates to lock the suture.

[0042] Fig. 10C Shown with Fig. 10A Disconnect the suture lock from the adapter.

[0043] Fig. 10D shows a structure constructed with Fig. 10A The suture lock is used together with the locking pin.

[0044] Fig.11A is a top view of an exemplary locking and release mechanism by which a suture lock may be connected to and / or disconnected from an adapter.

[0045] Fig. 11B yes Fig.11ASide view of the locking and release mechanism.

[0046] Fig. 12A is a side view of another exemplary locking and release mechanism by which a suture lock may be connected to and / or disconnected from an adapter.

[0047] Fig. 12B yes Fig. 12A Side view of the locking and release mechanism.

[0048] Fig.13 is a top view of another exemplary locking and release mechanism by which a suture lock may be connected to and / or disconnected from an adapter, the locking and release mechanism including an axial locking mechanism and a rotational locking mechanism.

[0049] Fig.14A Based on an example Fig.13 Cross-sectional view of the rotary locking mechanism.

[0050] Fig. 14B According to another example Fig.13 Cross-sectional view of the rotary locking mechanism.

[0051] Fig.15 is a top view of a locking and release mechanism by which a suture lock may be connected to and / or disconnected from an adapter according to yet another example. DETAILED DESCRIPTION

[0052] General considerations

[0053] It should be understood that the disclosed examples may be suitable for delivery and implantation of prosthetic devices in any native heart annulus (e.g., the pulmonary annulus, mitral annulus, and tricuspid annulus) and may be used with any of a variety of delivery methods (e.g., retrograde, antegrade, transseptal, transventricular, transatrial, etc.).

[0054] For the purpose of this description, certain aspects, advantages and novel features of examples of the present disclosure are described herein. The disclosed methods, devices and systems should not be interpreted as limiting in any way. Instead, the present disclosure relates to all novel and non-obvious features and aspects of the various disclosed examples, individually and in various combinations and sub-combinations of each other. The methods, devices and systems are not limited to any specific aspect or feature or combination thereof, nor do the disclosed examples require the existence of any one or more specific advantages or problem solving. The technology from any example can be combined with the technology described in any one or more examples in other examples. In view of the many possible examples to which the principles of the disclosed technology can be applied, it should be recognized that the examples shown are merely preferred examples and should not be considered to limit the scope of the disclosed technology.

[0055] Although the operations of some disclosed examples are described in a particular sequential order for ease of presentation, it should be understood that this description includes rearrangement unless the specific language set forth below requires a particular order. For example, the operations described in sequence may be rearranged or performed simultaneously in some cases. In addition, for simplicity, the accompanying drawings may not show the various ways in which the disclosed methods can be used in conjunction with other methods. In addition, this specification sometimes uses terms such as "providing" or "implementing" to describe the disclosed methods. These terms are high-level abstractions of the actual operations performed. The actual operations corresponding to these terms may vary depending on the specific implementation, and are easily discernible by those of ordinary skill in the art.

[0056] As used in this application and the claims, the singular forms "a", "an", and "the" include the plural forms unless the context clearly dictates otherwise. In addition, the term "includes" means "comprises". Furthermore, the terms "coupled" and "connected" generally mean electrical, electromagnetic, and / or physical (e.g., mechanical or chemical) connections or links, and do not exclude the presence of intervening elements between connected or associated items in the absence of specific language to the contrary.

[0057] As used herein, the term "proximal" refers to a position, direction or part of a device that is closer to a user and further away from an implantation site. As used herein, the term "distal" refers to a position, direction or part of a device that is further away from a user and closer to an implantation site. Thus, for example, the proximal movement of a device is the movement of the device away from the implantation site and toward the user (e.g., leaving the patient's body), while the distal movement of the device is the movement of the device away from the user and toward the implantation site (e.g., entering the patient's body). The terms "longitudinal" and "axial" refer to axes extending in proximal and distal directions, unless otherwise clearly defined.

[0058] As used herein, the terms "approximately" and "about" mean the listed value and any value within 10% of the listed value. For example, "about 1 mm" means any value between about 0.9 mm and about 1.1 mm, inclusive.

[0059] Direction and other relative references (e.g., inside, outside, up, down, etc.) may be used to facilitate discussion of the drawings and principles herein, but are not intended to be limiting. For example, certain terms such as "inside," "outside," "top," "below," "inside," "outside," etc. may be used. When dealing with relative relationships, particularly with respect to the examples shown, such terms are used to provide some clarity of description, where applicable. However, such terms are not intended to imply absolute relationships, positions, and / or orientations. For example, for an object, the "upper" portion may simply become the "lower" portion by flipping the object. Nevertheless, it is still the same part and the object remains unchanged. As used herein, "and / or" means "and" or "or," as well as "and" and "or."

[0060] Exemplary Transcatheter Heart Valve Replacement Procedure

[0061] Described herein are various systems, devices, methods, etc. that can be used in or with a delivery device to deliver a prosthetic implant (eg, a prosthetic valve, a docking device, etc.) into a patient.

[0062] In some examples, the delivery device can be configured to deliver and implant a docking device at an implantation site, such as a native valve annulus. The docking device can be configured to more securely hold an expandable prosthetic valve implanted within the docking device at the native valve annulus. For example, the docking device can provide or form a more circular and / or more stable anchoring site, landing zone, or implantation area at the implantation site, where the prosthetic valve can be expanded or otherwise implanted. By providing such an anchoring or docking device, a replacement prosthetic valve can be more securely implanted and maintained at various valve annuli, including at the mitral valve annulus that does not have a natural circular cross-section.

[0063] In some examples, the docking device may be arranged in the outer shaft of the delivery device. The sleeve shaft can cover or surround the docking device in the delivery device during delivery to the target implantation site. The pusher shaft can be arranged in the outer shaft, adjacent to the docking device, and is configured to push the docking device out of the outer shaft to position the docking device at the target implantation site. The sleeve shaft can also surround the pusher shaft in the outer shaft of the delivery device. After the docking device is positioned at the target implantation site, the sleeve shaft can be removed from the docking device and retracted into the outer shaft of the delivery device.

[0064] Fluid (e.g., flushing fluid, such as heparinized saline, etc.) can be provided to the pusher shaft lumen defined within the interior of the pusher shaft and the delivery shaft lumen defined between the sleeve shaft and the outer shaft of the delivery device. Fluid from the pusher shaft lumen can then flow to the sleeve shaft lumen defined between the docking device and the sleeve shaft and between the sleeve shaft and the pusher shaft. By providing a consistent fluid flow through these lumens of the delivery device, stagnation of blood within the delivery device can be reduced or avoided, thereby reducing or preventing thrombosis.

[0065] exist Figure 1 and Figure 2A-2B An exemplary transcatheter heart valve replacement procedure is shown in a schematic illustration of , which uses a first exemplary delivery device to deliver a docking device to a native valve annulus and then uses a second exemplary delivery device to deliver a prosthetic heart valve (e.g., THV) inside the docking device.

[0066] As described above, a defective native heart valve can be replaced with a THV. However, in some cases, such a THV may not be able to adequately fix itself to the native tissue (e.g., to the leaflets and / or annulus of the native heart valve), and may be undesirably displaced relative to the native tissue, thereby causing paravalvular leakage, valve dysfunction, and / or other problems. Therefore, a docking device may first be implanted at the native annulus, and then the THV may be implanted within the docking device to help anchor the THV to the native tissue and provide a seal between the native tissue and the THV.

[0067] Figure 1 and Figure 2A-2B An exemplary transcatheter heart valve replacement procedure utilizing a docking device is shown. During the procedure, the user first uses the docking device delivery device (see, e.g., Figure 1 ) delivering and implanting a docking device at the patient's native heart valve, and then removing the docking device delivery device from the patient after implantation of the docking device (see, e.g. Figure 2A ), and finally implanting the THV into the docking device using a prosthetic valve delivery device (see e.g. Figure 2B ).

[0068] Figure 1 The first stage in an exemplary mitral valve replacement surgery is shown, in which a docking device 10 is implanted at the mitral valve 12 of the heart 14 of a patient 16 using a docking device delivery apparatus 18 (which may also be referred to herein as a "docking delivery catheter," "docking delivery system," or simply a "delivery system").

[0069] Typically, the docking device delivery apparatus 18 includes a delivery shaft 20, a handle 22, and a pusher assembly 24. The delivery shaft 20 can be configured to extend into the patient's vasculature and provide a pathway for the docking device 10 to reach a target implantation site (e.g., the mitral valve 12). Specifically, a user can advance the delivery shaft 20 (which is configured to receive and / or retain the docking device 10 therein) through the patient's vasculature to the implantation site. In some examples, the delivery shaft 20 can include an outer sheath or shaft that defines a lumen, and the pusher assembly 24 and / or the docking device 10 can be configured to be received within the lumen and / or be advanced within the lumen.

[0070] The handle 22 is configured to be grasped and / or otherwise held by a user to advance the delivery shaft 20 through the patient's vasculature. Specifically, the handle 22 can be coupled to the proximal end 26 of the delivery shaft 20 and can be configured to remain accessible to the user (e.g., outside the patient 16) during the docking device implantation surgery. In this way, the user can advance the delivery shaft 20 through the patient's vasculature by applying a force on the handle 22 (e.g., pushing the handle). In some examples, the delivery shaft 20 can be configured to carry the pusher assembly 24 and / or the docking device 10 as it advances through the patient's vasculature. In this way, when the user grasps the handle 22 and pushes the delivery shaft 20 deeper into the patient's vasculature, the docking device 10 and / or the pusher assembly 24 can be advanced synchronously with the delivery shaft 20 through the patient's vasculature.

[0071] In some examples, the handle 22 can include one or more articulation members 28 configured to facilitate guiding the delivery shaft 20 through the patient's vasculature. Specifically, the articulation member 28 can include one or more of a knob, button, wheel, and / or other types of physically adjustable control members configured to be adjusted by a user to flex, bend, twist, rotate, and / or otherwise articulate the distal end 30 of the delivery shaft 20, thereby facilitating guiding the delivery shaft 20 through the patient's vasculature.

[0072] The pusher assembly 24 can be configured to deploy and / or implant the docking device 10 at an implantation site (e.g., a native valve). Specifically, the pusher assembly 24 can be configured to be adjusted by a user to advance the docking device 10 through the delivery shaft 20 and push the docking device 10 out of the distal end 30 of the delivery shaft 20. As described above, the pusher assembly 24 can be configured to extend through the delivery shaft 20 within a lumen defined by the outer sheath of the delivery shaft 20. The pusher assembly 24 can also be coupled to the docking device 10 so that when the pusher assembly 24 advances through the delivery shaft 20, the pusher assembly 24 can push the docking device 10 through and / or out of the delivery shaft 20. In other words, since it is held, maintained, and / or otherwise coupled to the pusher assembly by the pusher assembly 24, the docking device 10 can advance through and / or out of the delivery shaft 20 in sync with the pusher assembly 24.

[0073] The pusher assembly 24 can include a pusher shaft 32, and in some examples, can also include a sleeve shaft 34. The pusher shaft 32 can be configured to push the docking device 10 through the delivery shaft 20 and out of the distal end 30 of the delivery shaft 20, while the sleeve shaft 34, when included, can have a distal section configured to cover the docking device 10 within the delivery shaft 20 while pushing the docking device 10 out of the delivery shaft 20 and positioning the docking device 10 at the implantation site. In some examples, as further described below, the pusher shaft 32 can be covered by the sleeve shaft 34 and disposed within an outer shaft or connector of a pusher handle (also referred to herein as a "hub assembly") 36.

[0074] In some examples, the pusher assembly 24 can include a pusher handle 36 that is coupled to the pusher shaft 32 and is configured to be grasped and pushed by a user to axially translate the pusher shaft 32 relative to the delivery shaft 20 (e.g., push the pusher shaft 32 into and / or out of the distal end 30 of the delivery shaft 20). The sleeve shaft 34 can be configured to be retracted and / or withdrawn from the docking device 10 after positioning the docking device 10 at the target implantation site. For example, the pusher assembly 24 can include a sleeve handle 38 that is coupled to the sleeve shaft 34 and is configured to be pulled by a user to retract (e.g., axially move) the sleeve shaft 34 relative to the pusher shaft 32.

[0075] The pusher assembly 24 can be removably coupled to the docking device 10, and thus can be configured to be released, separated, disengaged, and / or otherwise disconnected from the docking device 10 once the docking device 10 has been deployed at the target implantation site. As just one example, the pusher assembly 24 (e.g., the pusher shaft 32) can be removably coupled to the docking device 10 via a wire, string, yarn, suture, or other suitable material that is tied or sewn to the docking device 10.

[0076] In some examples, the pusher assembly 24 may include a suture locking assembly 40 (also referred to as a "suture lock") configured to receive and / or hold a thread or other suitable material coupled to the docking device 10 via a suture. The thread or other suitable material forming the suture may extend from the docking device 10 through the pusher assembly 24 to the suture locking assembly 40. The suture locking assembly 40 may also be configured to cut the suture to release, separate, disengage, and / or otherwise disconnect the docking device 10 from the pusher assembly 24. For example, the suture locking assembly 40 may include a cutting mechanism configured to be adjusted by a user to cut the suture.

[0077] Additional details of the docking device delivery apparatus and its variations are provided below with reference to Figure 4-15 Further described and described in International Application No. PCT / US2020 / 36577, which is incorporated herein by reference in its entirety.

[0078] Prior to inserting the docking device delivery apparatus 18 into the vasculature of the patient 16, the user may first make an incision in the patient's body to access the blood vessel 42. For example, Figure 1 As shown in , a user can make an incision in the patient's groin to access the femoral vein. Therefore, in some examples, the blood vessel 42 can be the femoral vein.

[0079] After making an incision at the blood vessel 42, the user can insert the introducer device 44, the guidewire 46 and / or other devices (e.g., the delivery shaft 20, the pusher shaft 32 and / or the sleeve shaft 34 of the docking device delivery apparatus 18, the catheter, and / or other delivery devices, the docking device 10, the prosthetic valve, etc.) through the incision and into the blood vessel 42. The introducer device 44 (which may include an introducer sheath) can be configured to facilitate the percutaneous introduction of the guidewire 46 and / or other devices (e.g., the docking device delivery apparatus 18) through the blood vessel 42, and may extend only a portion of the blood vessel 42 even when it is fully inserted by the user (i.e., it may extend through the blood vessel 42 toward the heart 14, but may stop before the heart 14). On the other hand, the guidewire 46 can be configured to guide the delivery device (e.g., the docking device delivery apparatus 18, the prosthetic valve delivery apparatus, the catheter, etc.) and its associated devices (e.g., the docking device, the prosthetic heart valve, etc.) to the target implantation site, and thus can extend all the way through the blood vessel 42 and into the left atrium 48 of the heart 14. Specifically, the user may advance the guidewire 46 through the blood vessel 42 (e.g., through the femoral vein and the inferior vena cava) to the right atrium 50 of the heart 14. The user may make a small incision in the atrial septum 52 of the heart 14 to allow the guidewire 46 to pass from the right atrium 50 of the heart 14 to the left atrium 48, and then may advance the guidewire 46 through the incision in the atrial septum 52 into the left atrium 48. Thus, the guidewire 46 may provide a path that the docking device delivery apparatus 18 may follow as it is advanced through the patient's vasculature to ensure that the docking device delivery apparatus 18 does not perforate the wall of the blood vessel 42 and / or other vasculature tissue.

[0080] After positioning the guidewire 46 within the left atrium 48, the user may insert the docking device delivery device 18 (e.g., delivery shaft 20) into the patient 16 by advancing the docking device delivery device 18 through the introducer device 44 and over the guidewire 46. The user may then continue to advance the docking device delivery device 18 along the guidewire 46 through the patient's vasculature until the docking device delivery device 18 reaches the left atrium 48, as shown in FIG. Figure 1 Specifically, a user can advance the delivery shaft 20 of the docking device delivery device 18 by grasping the handle 22 of the docking device delivery device 18 and applying force thereon (e.g., pushing the handle). When advancing the delivery shaft 20 through the patient's vasculature, the user can adjust one or more articulated members 28 of the handle 22 to guide various turns, corners, constrictions, and / or other obstacles in the patient's vasculature.

[0081] After the delivery shaft 20 reaches the left atrium 48, the user can use the handle 22 (e.g., the hinge member 28) to position the distal end 30 of the delivery shaft 20 at and / or near the posteromedial commissure of the mitral valve 12. The user can then use the pusher assembly 24 to push the docking device 10 out of the distal end 30 of the delivery shaft 20 to deploy and / or implant the docking device 10 at the mitral valve 12. For example, the user can actuate the pusher handle 36 to axially translate the pusher shaft 32 in the distal direction relative to the delivery shaft 20 so that the docking device 10 (which can be covered by the sleeve shaft 34) is deployed out of the delivery shaft 20 and moved to a desired position at the target implantation site.

[0082] In some examples, the docking device 10 can be constructed, formed, and / or include a shape memory material so that when it leaves the delivery shaft 20 and is no longer constrained by the delivery shaft 20, it can return to its initial, pre-formed shape. As an example, the docking device 10 can be initially formed into a coil so that when it leaves the delivery shaft 20 and returns to its initial curled configuration (e.g., Figure 3 , and further described below), can be wrapped around the ventricular side of the native valve leaflet.

[0083] After pushing the ventricular portion of the docking device 10 (i.e., the portion of the docking device 10 that is configured to be positioned / disposed within the left ventricle 56 and / or on the ventricular side of the mitral valve leaflets), the user may then release the remainder of the docking device 10 (the atrial portion of the docking device 10) from the delivery shaft 20 within the left atrium 48. Specifically, the user may retract the delivery shaft 20 relative to the docking device 10, away from the posteromedial commissure of the mitral valve 12. In some examples, the user may maintain the position of the pusher shaft 32 while retracting the delivery shaft 20 proximally (e.g., by applying a retaining force and / or a pushing force on the pusher shaft 32), such that the delivery shaft 20 is withdrawn and / or otherwise retracted relative to the docking device 10 and the pusher shaft 32. In this way, the pusher shaft 32 may hold the docking device 10 in place while the user retracts the delivery shaft 20, thereby releasing the docking device 10 from the delivery shaft 20. In some examples, the user may also retract the sleeve shaft 34 from the docking device 10 to reveal the docking device 10. In some examples, the user may also deploy an expandable sleeve of the docking device 10 .

[0084] After the docking device 10 is deployed and / or implanted, the user can disengage and / or otherwise disconnect the docking device delivery device 18 from the docking device 10 by, for example, cutting the sutures tied to the docking device 10. As just one example, the user can cut the sutures with the cutting mechanism of the suture locking assembly 40. Once the docking device 10 is disconnected from the docking device delivery device 18, the user can retract the entire docking device delivery device 18 (e.g., the delivery shaft 20, the handle 22, and the pusher assembly 24) from the patient 16 so that the user can deliver and implant the THV at the mitral valve 12. In one example, the docking device 10 and the THV can be delivered on two different, separate delivery devices, so the user may need to remove the docking device delivery device 18 from the patient 16 to make room for the THV delivery device. As another example, the user may need to remove the docking device delivery device 18 from the patient 16 to load the THV onto the same delivery device. In either example, the user may need to remove the docking device delivery device 18 from the patient 16 before implanting the THV.

[0085] Figure 2A The second stage in the mitral valve replacement surgery is shown, in which the docking device 10 has been fully deployed and implanted at the mitral valve 12. The docking device delivery device 18 (including the delivery shaft 20) has been removed from the patient 16, so that only the guidewire 46 and the introducer device 44 remain in the patient 16. The introducer device 44 can remain in the patient 16 to assist in the percutaneous insertion of the THV and valve delivery device into the patient 16, while the guidewire 46 can remain in the patient's vasculature to assist in advancing the THV and prosthetic valve delivery device through the patient's vasculature. Specifically, the guidewire 46 can ensure that the THV and prosthetic valve delivery device do not penetrate the wall of the blood vessel 42 and / or other vascular system tissue when advancing through the patient's vasculature. In some examples, the user can advance the guidewire 46 through the mitral valve 12 and into the left ventricle 56 to ensure that the guidewire 46 guides the THV and valve delivery device all the way to the mitral valve 12 and into the docking device 10.

[0086] like Figure 2A As shown in , the docking device 10 can be configured to wrap around the ventricular side of the leaflets of the mitral valve 12 and press the leaflets radially inward (i.e., radially compress the leaflets) to adjust the size and / or shape of the opening between the two leaflets of the mitral valve 12. For example, the docking device 10 can be configured to reduce the size of the opening of the mitral valve 12 and / or change the shape of the opening to more closely match the cross-sectional shape and / or contour of the THV (e.g., making the opening more round for a cylindrical THV). By contracting the mitral valve 12 in this manner, the docking device 10 can provide a tighter fit between the THV and the mitral valve 12, and therefore provide a better seal.

[0087] Figure 2B The third stage in the mitral valve replacement surgery is shown, in which the user uses the prosthetic heart valve delivery device 58 to deliver and / or implant the prosthetic heart valve 54 within the docking device 10 and / or at the mitral valve 12. Therefore, the docking device 10 and the prosthetic heart valve 54 can be delivered on different delivery devices at different stages in the mitral valve replacement surgery. Specifically, during the first stage of the mitral valve replacement surgery, the docking device delivery device 18 can be used to deliver the docking device 10 to the mitral valve 12, and then the prosthetic heart valve delivery device 58 can be used to deliver the prosthetic heart valve 54.

[0088] The prosthetic heart valve delivery device 58 includes a delivery shaft 60 and a handle 62 coupled to a proximal end 64 of the delivery shaft 60. The delivery shaft 60 can be configured to extend into the vasculature of a patient to deliver, implant, expand, and / or otherwise deploy the prosthetic heart valve 54 within the docking device 10 at the mitral valve 12. The handle 62 can be the same as or similar to the handle 22 of the docking device delivery device 18 and can be similarly configured to be grasped and / or otherwise held by a user to advance the delivery shaft 60 through the vasculature of the patient.

[0089] In some examples, the handle 62 can include one or more articulation members 66 configured to facilitate guiding the delivery shaft 60 through the patient's vasculature. Specifically, the articulation members 66 can include one or more of a knob, button, wheel, and / or other types of physically adjustable control members configured to be adjusted by a user to flex, bend, twist, rotate, and / or otherwise articulate the distal end 68 of the delivery shaft 60, thereby facilitating guiding the delivery shaft 60 through the patient's vasculature.

[0090] In some examples, the prosthetic heart valve delivery device 58 can include an expansion mechanism 70 configured to radially expand and deploy the prosthetic heart valve 54. For example, the expansion mechanism 70 can include an inflatable balloon configured to be inflated to radially expand the prosthetic heart valve 54 within the docking device 10. The expansion mechanism 70 can be included in and / or coupled to the delivery shaft 60 at and / or near the distal end 68 of the delivery shaft 60. In other examples, the prosthetic heart valve 54 can be self-expanding and can be configured to radially expand on its own without the expansion mechanism 70. In other examples, the prosthetic heart valve 54 can be mechanically expandable, and the prosthetic heart valve delivery device 58 can include one or more mechanical actuators configured to radially expand the prosthetic heart valve 54.

[0091] Additional details of the prosthetic heart valve 54 and its components are described, for example, in U.S. Pat. Nos. 9,393,110, 9,339,384, 9,155,619, 8,652,202, and 6,730,118, U.S. Patent Publication Nos. 2019 / 0374337, 2019 / 0192296, 2019 / 0046314, 2018 / 0153689, and PCT Patent Application Publication Nos. WO / 2021 / 188476 and WO / 2020 / 247907, the disclosures of which are incorporated herein in their entirety for all purposes.

[0092] The prosthetic heart valve 54 can be coupled to the delivery shaft 60 at and / or near the distal end 68 of the delivery shaft 60. In certain examples where the prosthetic heart valve delivery apparatus 58 includes an expansion mechanism 70, the prosthetic heart valve 54 can be mounted on the expansion mechanism 70 in a radially compressed configuration. In some examples, the prosthetic heart valve 54 can be removably coupled to the delivery shaft 60 such that after the prosthetic heart valve 54 is radially expanded and deployed from the prosthetic heart valve delivery apparatus 58, the prosthetic heart valve delivery apparatus 58 can be retracted away from the implanted prosthetic heart valve 54 and removed from the patient 16.

[0093] The prosthetic heart valve 54 can be configured to receive and / or remain within the docking device 10. That is, the docking device 10 can be configured to receive the prosthetic heart valve 54 and help anchor the prosthetic heart valve 54 to the mitral valve 12. As will be explained in more detail below, the docking device 10 can also be configured to provide a seal between the prosthetic heart valve 54 and the leaflets of the mitral valve to reduce paravalvular leakage around the prosthetic heart valve 54. Specifically, as introduced above, the docking device 10 can initially contract the leaflets of the mitral valve 12. When the prosthetic heart valve 54 is radially expanded within the docking device 10 (e.g., by inflation of the expansion mechanism 70), the prosthetic heart valve can push the leaflets against the docking device 10. Therefore, the docking device 10 and the prosthetic heart valve 54 can be configured to clamp the leaflets of the mitral valve 12 when the prosthetic heart valve 54 is expanded within the docking device 10. In this way, the docking device 10 can provide a seal between the leaflets of the mitral valve 12 and the prosthetic heart valve 54 .

[0094] In some examples, one or more of the docking device delivery apparatus 18, the prosthetic heart valve delivery apparatus 58, and / or the introducer apparatus 44 may include one or more flushing ports 72 (see, e.g., Figure 1 ), wherein the one or more flushing ports are configured to supply flushing fluid to a lumen thereof (e.g., the delivery shaft 20 of the docking device delivery apparatus 18, the delivery shaft 60 of the prosthetic heart valve delivery apparatus 58, and / or the lumen of the introducer apparatus 44) to prevent and / or reduce the likelihood of blood clot (e.g., thrombus) formation.

[0095] As with the delivery of docking device 10, the user may insert prosthetic heart valve delivery device 58 (e.g., delivery shaft 60) into patient 16 by advancing prosthetic heart valve delivery device 58 through introducer device 44 and over guidewire 46. The user may continue to advance prosthetic heart valve delivery device 58 along guidewire 46 through the patient's vasculature until prosthetic heart valve delivery device 58 reaches mitral valve 12, as shown in FIG. Figure 2B Specifically, a user can advance the delivery shaft 60 of the prosthetic heart valve delivery device 58 by grasping the handle 62 of the prosthetic heart valve delivery device 58 and applying force thereon (e.g., pushing the handle). When advancing the delivery shaft 60 through the patient's vasculature, the user can adjust one or more hinged members 66 of the handle 62 to guide various turns, corners, constrictions, and / or other obstacles in the patient's vasculature.

[0096] The user can advance the delivery shaft 60 along the guidewire 46 until the prosthetic heart valve 54 and / or the expansion mechanism 70 are positioned / set within the docking device 10 and / or the mitral valve 12. For example, the user can advance the delivery shaft 60 along the guidewire 46 until the delivery shaft 60 extends through the mitral valve 12 so that the distal end 68 of the delivery shaft 60 is positioned / set within the left ventricle 56. After the prosthetic heart valve 54 is properly positioned / set within the docking device 10, the user can, for example, radially expand the prosthetic heart valve 54 with the expansion mechanism 70 to its fully expanded position or configuration. In some examples, the user can lock the prosthetic heart valve 54 in its fully expanded position (e.g., with a locking mechanism) to prevent valve collapse. After expanding and deploying the prosthetic heart valve 54, the user can disengage and / or otherwise disconnect the delivery shaft 60 from the prosthetic heart valve 54 and remove the delivery shaft 60 from the patient.

[0097] Additional examples of docking delivery systems and methods of implanting docking devices and implanting prosthetic valves within docking devices are described in International Patent Application PCT / US2021 / 056150, which is incorporated herein by reference in its entirety.

[0098] although Figure 1 and Figure 2A-2B A mitral valve replacement procedure is specifically shown, but it should be appreciated that the same and / or similar procedures can be used to replace other heart valves (e.g., tricuspid valve, pulmonary valve, and / or aortic valve). In addition, the same and / or similar delivery devices (e.g., docking device delivery apparatus 18, prosthetic heart valve delivery apparatus 58, introducer device 44, and / or guidewire 46), docking devices (e.g., docking device 10), replacement heart valves (e.g., prosthetic heart valve 54), and / or components thereof can be used to replace these other heart valves.

[0099] For example, when replacing a native tricuspid valve, the user may also enter the right atrium 50 via the femoral vein, but may not need to enter the left atrium 48 through the atrial septum 52. Instead, the user may leave the guidewire 46 in the right atrium 50 and perform the same and / or similar docking device implantation process at the tricuspid valve. Specifically, the user may push the docking device 10 out of the delivery shaft 20 around the ventricular side of the tricuspid valve leaflet, release the remaining portion of the docking device 10 from the delivery shaft 20 in the right atrium 50, and then remove the delivery shaft 20 of the docking device delivery device 18 from the patient 16. The user may then advance the guidewire 46 through the tricuspid valve into the right ventricle, and perform the same and / or similar prosthetic heart valve implantation process at the tricuspid valve within the docking device 10. Specifically, the user may advance the delivery shaft 60 of the prosthetic heart valve delivery device 58 along the guidewire 46 through the patient's vascular system until the prosthetic heart valve 54 is positioned / set within the docking device 10 and the tricuspid valve. The user may then expand the prosthetic heart valve 54 within the docking device 10 before removing the prosthetic heart valve delivery apparatus 58 from the patient 16. In another example, the user may perform the same and / or similar procedure to replace the aortic valve, but may access the aortic valve from the outflow side of the aortic valve via the femoral artery.

[0100] In addition, despite Figure 1 and Figure 2A-2B A mitral valve replacement procedure is shown approaching the mitral valve 12 from the left atrium 48 via the right atrium 50 and the femoral vein, but it should be appreciated that the mitral valve 12 may alternatively be approached from the left ventricle 56. For example, a user may access the mitral valve 12 from the left ventricle 56 via the aortic valve by advancing one or more delivery devices through the arteries to the aortic valve and then into the left ventricle 56 through the aortic valve.

[0101] Exemplary Docking Devices

[0102] Figure 3 An example of a docking device 100 configured to receive a prosthetic heart valve is shown. For example, the docking device 100 can be implanted within a native valve annulus, as described above with reference to Figure 1 and Figure 2A As stated. Figure 1 and Figure 2A-2B As shown, the docking device 100 can be configured to receive and secure a prosthetic valve within the docking device, thereby securing the prosthetic valve at the native valve annulus.

[0103] refer to Figure 3, the docking device 100 may include two main components: a coil 102 and a protective member 104 covering at least a portion of the coil 102. In some examples, the coil 102 may include a shape memory material (e.g., a nickel-titanium alloy) so that the docking device 100 (and the coil 102) can move from a substantially straight configuration (also referred to as a "delivery configuration") when disposed within a delivery sheath of a delivery device (as described more fully below) to a helical configuration (also referred to as a "deployment configuration") after removal from the delivery sheath. Figure 3 ).

[0104] The coil 102 has a proximal end 102p and a distal end 102d. When disposed within a delivery sheath (e.g., during delivery of the docking device into the patient's vasculature), the body of the coil 102 between the proximal end 102p and the distal end 102d can form a substantially straight delivery configuration (i.e., without any curled or annular portions) so as to maintain a small radial profile when moving through the patient's vasculature. After being removed from the delivery sheath and deployed at the implantation site, the coil 102 can be moved from the delivery configuration to a spiral deployment configuration and wrapped around native tissue adjacent to the implantation site. For example, when the docking device is implanted at the location of a native valve, the coil 102 can be configured to surround the native leaflets of the native valve (and the chordae tendineae connecting the native leaflets to the adjacent papillary muscles, if present).

[0105] The docking device 100 can be releasably coupled to a delivery device. For example, in some examples, the docking device 100 can be coupled to the delivery device via a release suture, which can be configured to be tied to the docking device 100 and cut for removal (as described below with reference to Figure 4 and Figure 7 102p) In one example, the release suture can be tied to the docking device 100 through a small eye or eyelet 103 located adjacent to the proximal end 102p of the coil. In another example, the release suture can be tied around a circumferential recess located adjacent to the proximal end 102p of the coil 102.

[0106] In some examples, the docking device 100 in the deployed configuration can be configured to fit at the mitral valve position. In other examples, the docking device 100 can also be shaped and / or adapted to be implanted at other natural valve positions, such as at the tricuspid valve. In some examples, the geometry of the docking device 100 can be configured to engage natural anatomical structures, which can, for example, provide increased stability and reduced relative motion between the docking device 100, the prosthetic valve docked therein, and / or the natural anatomical structure. Reducing such relative motion can, in particular, prevent material degradation of the components of the docking device 100 and / or the prosthetic valve docked therein and / or prevent damage or trauma to natural tissue.

[0107] like Figure 3As shown in , the coil 102 in the deployed configuration may include a guide turn 106 (or "guide coil"), a central region 108, and a stabilizing turn 110 (or "stabilizing coil"). The central region 108 may have one or more spiral turns with substantially equal inner diameters. The guide turn 106 may extend from a distal end of the central region 108 and have a diameter that is larger than the diameter of the central region 108 (in one or more configurations). The stabilizing turn 110 may extend from a proximal end of the central region 108 and have a diameter that is larger than the diameter of the central region 108 (in one or more configurations).

[0108] In some examples, the central region 108 may include a plurality of helical turns, such as a proximal turn 108p connected to the stabilizing turn 110, a distal turn 108d connected to the guiding turn 106, and one or more intermediate turns 108m disposed between the proximal turn 108p and the distal turn 108d. Figure 3 In the example shown, there is only one intermediate turn 108m between the proximal turn 108p and the distal turn 108d. In other examples, there are more than one intermediate turn 108m between the proximal turn 108p and the distal turn 108d. Some of the spiral turns in the central region 108 can be full turns (i.e., rotated 360 degrees). In some examples, the proximal turn 108p and / or the distal turn 108d can be partial turns (e.g., rotated less than 360 degrees, such as 180 degrees, 270 degrees, etc.).

[0109] The size of the docking device 100 can generally be selected based on the size of the desired prosthetic valve to be implanted in the patient. In some examples, the central region 108 can be configured to maintain a radially expandable prosthetic valve. For example, when the prosthetic valve is radially expanded, the inner diameter of the spiral turns in the central region 108 can be configured to be smaller than the outer diameter of the prosthetic valve so that additional radial tension can act between the central region 108 and the prosthetic valve to keep the prosthetic valve in place. The spiral turns (e.g., 108p, 108m, 108d) in the central region 108 are also referred to herein as "functional turns."

[0110] The stabilizing turns 110 can be configured to help stabilize the docking device 100 in a desired position. For example, the radial dimension of the stabilizing turns 110 can be significantly larger than the radial dimension of the coil in the central region 108, so that the stabilizing turns 110 can be fully flared or extended outward to abut or push against the wall of the circulatory system, thereby improving the ability of the docking device 100 to remain in its desired position prior to implantation of the prosthetic valve. In some examples, the diameter of the stabilizing turns 110 is expected to be larger than the annulus, the plane of the native valve, and the atrium to achieve better stability. In some examples, the stabilizing turns 110 can be a full turn (i.e., rotated about 360 degrees). In some examples, the stabilizing turns 110 can be a partial turn (e.g., rotated between about 180 degrees and about 270 degrees).

[0111] In one particular example, when the docking device 100 is implanted at the native mitral valve location, the functional turns in the central region 108 may be substantially disposed in the left ventricle, and the stabilizing turns 110 may be substantially disposed in the left atrium. The stabilizing turns 110 may be configured to provide one or more contact points or contact areas between the docking device 100 and the left atrium wall, such as at least three contact points in the left atrium or full contact on the left atrium wall. In some examples, the contact points between the docking device 100 and the left atrium wall may form a plane that is substantially parallel to the plane of the native mitral valve.

[0112] As described above, the guide turns 106 can have a larger radial dimension than the spiral turns in the central region 108. The guide turns 106 can help to more easily guide the coil 102 around and / or through the chordae geometry and fully around all the native leaflets of the native valve (e.g., native mitral valve, tricuspid valve, etc.). For example, once the guide turns 106 are guided around the desired native anatomical structure, the remaining coils (e.g., functional turns) of the docking device 100 can also be guided around the same feature. In some examples, the guide turns 106 can be full turns (i.e., rotated about 360 degrees). In some examples, the guide turns 106 can be partial turns (e.g., rotated between about 180 degrees and about 270 degrees). In some examples, when the prosthetic valve is radially expanded within the central region 108 of the coil, the functional turns in the central region 108 can further expand radially. Therefore, the guide turns 106 can be pulled out in the proximal direction and become part of the functional turns in the central region 108.

[0113] like Figures 3A-3D As shown in, in some examples, at least a portion of the coil 102 can be surrounded by a first cover 112. In some examples, the first cover 112 can cover the entire length of the coil 102. In some examples, the first cover 112 only covers a selected portion of the coil 102. In some examples, the first cover 112 can be covered on the coil 102 and / or combined on the coil. In some examples, the first cover 112 can be a cushion-filled layer to protect the coil. The first cover 112 can be made of various natural and / or synthetic materials. In a specific example, the first cover 112 can include expanded polytetrafluoroethylene (ePTFE). In some examples, the first cover 112 can be fixedly attached to the coil 102 (for example, by means of textured surface resistance, sutures, glue, thermal bonding or any other means) so as to limit or prohibit the relative axial movement between the first cover 112 and the coil 102.

[0114] like Figure 3A-3BAs shown in, in some examples, the docking device 100 may also include a retaining element 114 that surrounds at least a portion of the coil 102 and is at least partially covered by the protective member 104. In some cases, the retaining element 114 may include a braided material. In addition, the retaining element 114 may provide a surface area that promotes or promotes tissue ingrowth and / or adhesion, and / or reduces trauma to natural tissue. For example, the retaining element 114 may have a textured outer surface that is configured to promote tissue ingrowth. In some cases, the retaining element 114 may be impregnated with a growth factor to stimulate or promote tissue ingrowth.

[0115] In some examples, at least a portion of the first cover 112 can be surrounded by the retaining element 114. In some examples, the first cover 112 can extend through the entire length of the retaining element 114. In some examples, the distal portion of the retaining element 114 can extend axially beyond the distal end of the protective member 104 (i.e., be positioned distal to the distal end of the protective member), and the proximal portion of the retaining element 114 can extend axially beyond the proximal end 105 of the protective member 104 (i.e., be positioned proximal to the proximal end of the protective member) to help retain the prosthetic valve and tissue ingrowth.

[0116] The retaining element 114 can be designed to interact with the guard member 104 to limit or resist movement of the guard member 104 relative to the coil 102. For example, the proximal end 105 of the guard member 104 can have an inner diameter that is substantially the same as the outer diameter of the retaining element 114. Thus, the inner surface of the guard member 104 at the proximal end 105 can frictionally interact or engage with the retaining element 114, such that axial movement of the proximal end 105 of the guard member 104 relative to the coil 102 can be hindered by the friction force applied by the retaining element 114.

[0117] like Figures 3A-3D As shown in , in some examples, the protective member 104 can include an expandable member 116 and a second cover 118 surrounding the outer surface of the expandable member 116. In some examples, the expandable member 116 surrounds at least a portion of the first cover 112. In some examples, the first cover 112 can extend (completely or partially) through the expandable member 116.

[0118] In some examples, the expandable member 116 may include a braided structure, such as a braided wire mesh or a grid. In some examples, the expandable member 116 may include a shape memory material, which is shaped and / or pre-configured to expand to a specific shape and / or size when unconstrained (e.g., when deployed at a natural valve position). For example, the expandable member 116 may have a braided structure containing a shape memory alloy with superelastic properties, such as a nickel-titanium alloy. In some examples, the expandable member 116 may have a braided structure containing a ternary shape memory alloy with superelastic properties, such as NiTiX, where X may be chromium (Cr), cobalt (Co), zirconium (Zr), hafnium (Hf), etc. In some examples, the expandable member 116 may include a metal material that does not have shape memory properties. Examples of such metal materials include cobalt-chromium, stainless steel, etc. In a specific example, the expandable member 116 may include nickel-free austenitic stainless steel, where nickel may be completely replaced by nitrogen. In another specific example, the expandable member 116 may include a cobalt-chromium or cobalt-nickel-chromium-molybdenum alloy of titanium with a significantly low density. The number of wires (or fibers, strands, etc.) forming the braided structure may be selected to achieve the desired elasticity and / or strength of the expandable member 116. In some examples, the number of wires used to braid the expansion member 116 may be in the range of 16 to 128 (e.g., 32 wires, 48 ​​wires, 64 wires, 96 wires, etc.). In some examples, the braiding density may be in the range of 20 per inch picks (PPI) to 70PPI, or in the range of 25PPI to 65PPI. In a specific example, the braiding density is about 36PPI. In another specific example, the braiding density is about 40PPI. In some examples, the diameter of the wire may be in the range of about 0.002 inches to about 0.004 inches. In a particular example, the diameter of the wire may be about 0.003 inches. In another example, the expandable member 116 can be a combination of a braided wire (which can include a shape memory material or a non-shape memory material) and a polymer material and / or a textile (e.g., polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE), polyetheretherketone (PEEK), thermoplastic polyurethane (TPU), etc.). For example, the expandable member 116 can include a braided wire frame embedded in a polymer material.

[0119] In some examples, expandable member 116 may include a braided wire frame coated with an elastomer (e.g., ePTFE, TPU, etc.) that can be elastically deformed when the braided wire frame is expanded and / or compressed. In some examples, expandable member 116 may include a braid and / or woven fabric that includes one or more metal wires and one or more polymer fibers. In other words, the metal wires and polymer fibers can be interwoven to define a braided structure. In some cases, the polymer fibers can have the same or approximately the same diameter as the metal wires. In other cases, the polymer fibers can have a smaller diameter than the metal wires (e.g., microfibers), and vice versa.

[0120] In yet another example, the expandable member 116 can include a polymer material, such as a thermoplastic material (eg, PET, polyetheretherketone (PEEK), thermoplastic polyurethane (TPU), etc.) that does not contain a braided wire frame.

[0121] In some examples, the expandable member 116 may include a foam structure. For example, the expandable member may include an expandable memory foam that can expand to a specific shape or a specific preset shape when the crimping pressure is removed before the docking device is delivered (e.g., the docking device 100 is removed from the delivery sheath).

[0122] The expandable member 116 can extend radially outward from the coil 102 and can move between a radially compressed (and axially extended) state and a radially expanded (and axially shortened) state. That is, the expandable member 116 can shorten axially when moving from the radially compressed state to the radially expanded state, and can lengthen axially when moving from the radially expanded state to the radially compressed state.

[0123] The second cover 118 can be configured to have such elasticity that when the expandable member 116 moves from the radially compressed (and axially extended) state to the radially expanded (and axially shortened) state, the second cover 118 can also radially expand and axially shorten together with the expandable member 116. In other words, the protective member 104 as a whole can move from the radially compressed (and axially extended) state to the radially expanded (and axially shortened) state.

[0124] In some examples, the second cover 118 can be configured to be atraumatic to natural tissue and / or promote tissue ingrowth into the second cover 118. For example, the second cover 118 can have holes to promote tissue ingrowth. In another example, the second cover 118 can be impregnated with growth factors to stimulate or promote tissue ingrowth. The second cover 118 can be made of any suitable material, including foam, cloth, fabric and / or polymer, which is flexible to allow the second cover to compress and expand. In one example, the second cover 118 can include a fabric layer made of a thermoplastic polymer material, such as polyethylene terephthalate (PET).

[0125] The guard member 104 may constitute a part of a cover assembly of the docking device 100. In some examples, the cover assembly may further include a first cover 112. In some examples, the cover assembly may further include a retaining element 114.

[0126] In some examples, when the docking device 100 is in the deployed configuration, the protective member 104 can be configured to cover a portion of the stable turn 110 of the coil 102. In some examples, the protective member 104 can be configured to cover at least a portion of the central region 108 of the coil 102, such as a portion of the proximal turn 108p. In some examples, the protective member 104 can extend over the entirety of the coil 102.

[0127] In some examples, the protective member 104 can expand radially to help prevent and / or reduce paravalvular leakage. Specifically, the protective member 104 can be configured to expand radially so as to form an improved seal closer to and / or against a prosthetic valve deployed within the docking device 100. In some examples, the protective member 104 can be configured to prevent and / or inhibit leakage at a location where the docking device 100 spans between the leaflets of a natural valve (e.g., at the commissure of the antenna leaflets). For example, in the absence of the protective member 104, the docking device 100 can push the natural leaflets apart at a point that spans the natural leaflets and allow leakage at that point (e.g., along the docking device or its sides). However, the protective member 104 can be configured to expand to cover and / or fill any opening at that point and inhibit leakage along the docking device 100.

[0128] In some examples, when the docking device 100 is deployed at a native atrioventricular valve, the protective member 104 can primarily cover a portion of the stabilizing turn 110 and / or a portion of the central region 108. Thus, the protective member 104 can help cover the atrial side of the ventricular valve to prevent and / or inhibit blood from leaking through the native leaflets, commissures, and / or around the exterior of the prosthetic valve by blocking blood in the atrium from flowing in the atrial-to-ventricular direction (i.e., antegrade blood flow)—rather than through the prosthetic valve. Positioning the protective member 104 on the atrial side of the valve can additionally or alternatively help reduce blood in the ventricle from flowing in the ventricle-to-atrial direction (i.e., retrograde blood flow).

[0129] In some examples, the guard member 104 can be positioned on the ventricular side of the ventricular valve to prevent and / or inhibit blood from leaking through the native leaflets, commissures, and / or around the exterior of the prosthetic valve by blocking blood in the ventricle from flowing in the ventricle-to-atrial direction (i.e., retrograde blood flow). Positioning the guard member 104 on the ventricular side of the valve can additionally or alternatively help reduce blood in the atrium from flowing in the atrial-to-ventricular direction (i.e., antegrade blood flow)—rather than through the prosthetic valve.

[0130] In some examples, the distal portion 104 d of the guard member 104 can be fixedly coupled to the coil 102 (eg, via sutures), and the proximal portion 104 p of the guard member 104 can be axially movable relative to the coil 102 .

[0131] When the docking device 100 is held in a substantially straight configuration within the delivery sheath, the expandable member 116 can be radially compressed by the delivery sheath and maintained in a radially compressed (and axially extended) state. The radially compressed (and axially extended) expandable member 116 can contact the retaining element 114 (see, e.g., Figure 3B ) or the first cover 112 (see e.g. Figure 3D ) such that no gap or cavity exists between the retaining element 114 and the expandable member 116 or between the first cover 112 (and / or the coil 102) and the expandable member 116.

[0132] The protective member 104 may also move from the delivery configuration to the deployed configuration after the docking device 100 is removed from the delivery sheath and changed from the delivery configuration to the deployed configuration. In some examples, the docking sleeve may be configured to cover the docking device 100 and retain it within the delivery sheath as the delivery sheath is guided through the patient's native valve. The docking sleeve may also, for example, help guide the docking device 100 around the native leaflets and cables. Retraction of the docking sleeve relative to the docking device 100 may reveal the protective member 104 and enable it to move from the delivery configuration to the deployed configuration. Specifically, without the constraints of the delivery sheath and the docking sleeve, the expandable member 116 may expand radially (and shorten axially) such that a space may be provided between the retaining element 114 and the expandable member 116 (see, e.g., Figure 3A ) and / or between the first cover 112 and the expandable member 116 (see e.g. Figure 3C ) creates a gap or cavity 111.

[0133] Since the distal portion 104d of the guard member 104 is fixedly coupled to the coil 102, and the proximal portion 104p of the guard member 104 can be axially movable relative to the coil 102, when the expandable member 116 moves from the radially compressed state to the radially expanded state, the proximal portion 104p of the guard member 104 can slide axially on the first cover 112 and slide toward the distal end 102d of the coil 102. Therefore, when the expandable member 116 is in the radially compressed state, the proximal portion 104p of the guard member 104 can be disposed closer to the proximal end 102p of the coil 102 than when the expandable member is in the radially expanded state.

[0134] In some examples, the second cover 118 can be configured to engage with a prosthetic valve deployed within the docking device 100 to form a seal between the prosthetic valve and the docking device 100 and reduce paravalvular leakage when the expandable member 116 is in the radially expanded state. The second cover 118 can also be configured to engage with natural tissue (e.g., a natural annulus and / or natural leaflets) to reduce paravalvular leakage between the docking device and / or the prosthetic valve and the natural tissue.

[0135] In some examples, when the guard member 104 is in the radially expanded state, the proximal portion 104p of the guard member 104 can have a tapered shape so that the diameter of the proximal portion 104p gradually increases from the proximal end 105 of the guard member 104 to the distally positioned main body portion of the guard member 104. This can, for example, help facilitate loading the docking device into a delivery sheath of a delivery device and / or retrieve the docking device and / or reposition the docking device into the delivery device during an implantation procedure. In addition, due to its small diameter, the proximal end 105 of the guard member 104 can frictionally engage with the retaining element 114, so that the retaining element 114 can reduce or prevent axial movement of the proximal portion 104p of the guard member 104 relative to the coil 102.

[0136] Additional examples of docking devices and protective members and methods of assembling docking devices (e.g., attaching the protective member to the coil) are described in international patent application PCT / US2021 / 056150.

[0137] Exemplary Delivery Devices

[0138] Figure 4 A docking device (eg, as described above with reference to Figure 3 An exemplary delivery device 220 for delivering the docking device 100 described above to a target implantation site (e.g., a heart and / or a natural valve of an animal, a human, a cadaver, etc.). In some examples, the delivery device 220 may be a transcatheter delivery device that can be used to guide the delivery of the docking device through the patient's vasculature, as described above with reference to Figure 1 and Figure 2A Explained.

[0139] The exemplary delivery device 220 is Figure 4 2, where the docking device 232 is at least partially deployed from the distal end of the delivery device 220 (e.g., for illustrative purposes). In some examples, the docking device 232 can be the above-referenced Figure 3 The docking device 100 described herein. The delivery device 220 may include a handle assembly 200 and an outer shaft 260 (also referred to herein as a "delivery sheath") extending distally from the handle assembly 200. The handle assembly 200 may include a handle 222 and a hub assembly 230 extending from the proximal end of the handle 222. The outer shaft 260 extends distally from the handle 222, while the hub assembly 230 extends proximally from the handle 222. According to one example, a more detailed view of the hub assembly 230 is shown in FIG. Figure 5 , as further described below.

[0140] like Figure 4As shown in , the handle assembly 200 may include a handle 222, which includes one or more knobs, buttons, wheels, etc. For example, the handle 222 may include knobs 224 and 226, which may be configured to control the deflection of the delivery device (e.g., the outer shaft 260 and / or the sleeve shaft 280 described below). For example, by rotating the knob (e.g., 224 or 226), the curvature of the outer shaft 260 may be adjusted so that the distal portion of the outer shaft 260 may be oriented at a desired angle.

[0141] like Figure 7 As shown in , the delivery device 220 may include a pusher shaft 290 and a sleeve shaft 280, which are coaxially located within the outer shaft 260 and each have a portion extending into the handle assembly 200. In addition, the outer shaft 260 can be configured to be axially movable relative to the sleeve shaft 280 and the pusher shaft 290. In some examples, the pusher shaft 290 and the sleeve shaft 280 can be respectively as described above with reference to Figure 1 The pusher shaft 32 and sleeve shaft 34 described above. The pusher shaft 290 can be configured to deploy the docking device 232 from the distal end portion of the outer shaft 260 when reaching the target implantation site. The sleeve shaft 280 can have a distal section (also referred to as a "docking sleeve") that is configured to cover the docking device 232 when inside the delivery device 220 and when positioned at the target implantation site. In some examples, the sleeve shaft 280 can have a lubricating and / or low-friction outer surface at least at the docking sleeve, for example, with the aid of a hydrophilic coating. Such a lubricated outer surface can improve the ease of surrounding the natural anatomical structure and reduce the risk of damage to the natural tissue.

[0142] Furthermore, the delivery device 220 may be configured to adjust the axial position of the sleeve shaft 280 to remove the docking sleeve of the sleeve shaft 280 from the docking device 232 after implantation at the target implantation site. Figure 6-7 FIG. 2 is a diagram showing an exemplary docking device 232 ( FIG. 20 ) deployed from the outer shaft 260 of the delivery device 220 and covered by the docking sleeve 281 of the sleeve shaft 280. Figure 6 ) and the exemplary docking device 232 after the sleeve shaft 280 has been retracted into the outer shaft 260 ( Figure 7 ) perspective view.

[0143] In certain examples, as further described below, deployment of the docking device 232 from the outer shaft 260 can be accomplished by manipulating the pusher shaft 290 and the sleeve shaft 280 using the hub assembly 230. For example, by pushing the pusher shaft 290 in the distal direction while holding the outer shaft 260 in place, or retracting the outer shaft 260 in the proximal direction while holding the pusher shaft 290 in place, or pushing the pusher shaft 290 in the distal direction while retracting the outer shaft 260 in the proximal direction, the docking device 232 can be pushed out of the distal end of the outer shaft 260, thereby changing from a delivery configuration to a deployed configuration.

[0144] In some examples, the pusher shaft 290 and the sleeve shaft 280 can be actuated independently of each other. In some examples, when the docking device 232 is deployed from the outer shaft 260, the pusher shaft 290 and the sleeve shaft 280 can be configured to move together with the docking device 232 in the axial direction. For example, actuating the pusher shaft 290 to push against the docking device 232 and move it out of the outer shaft 260 can also move the sleeve shaft 280 with the pusher shaft 290 and the docking device 232. Therefore, during the operation in which the docking device 232 is pushed to a position at the target implantation site via the pusher shaft 290, the docking device 232 can remain covered by the docking sleeve 281 of the sleeve shaft 280. Therefore, when the docking device 232 is initially deployed at the target implantation site, the lubricated docking sleeve 281 can promote the covered docking device 232 to surround the natural anatomical structure.

[0145] like Figure 4 and Figure 7 As shown in , during delivery, the docking device 232 can be coupled to the delivery apparatus 220 via a release suture 236 (or other retrieval line comprising a rope, yarn, or other material that can be configured to be tied around the docking device and cut for removal) that can extend through the pusher shaft 290. As described below with reference Figure 5 As further explained, the release suture 236 can extend through the lumen of the pusher shaft 290 through the delivery device 220 to the suture locking assembly 206 (or "suture lock") of the delivery device 220. The suture locking assembly 206 can be used as Figure 1 The suture lock 40 is shown in FIG.

[0146] like Figure 4 and Figure 5 As shown in FIG. 1 , the hub assembly 230 may include the suture locking assembly 206 and a sleeve handle attached thereto. A first example of a sleeve handle 234 is shown in FIG. Figure 4 As shown in FIG. 1 , a second example of a sleeve handle 208 is Figure 5The hub assembly 230 can be configured to control the pusher shaft 290 and sleeve shaft 280 of the delivery device 220 together (eg, to move them axially together), while the sleeve handle (eg, Figure 4 The sleeve handle 234 or Figure 5 The sleeve handle 208 in the outer shaft 260 can control the axial position of the sleeve shaft 280 relative to the pusher shaft 290. In this way, the operation of the various components of the handle assembly 200 can activate and control the operation of the components disposed within the outer shaft 260. In some examples, such as Figure 4 and Figure 5 As shown in , the hub assembly 230 can be coupled to the handle 222 via the connector 240 .

[0147] Figure 5 An example of a hub assembly 230 for a delivery device 220 is shown in more detail. As shown, the hub assembly 230 can include a Y-shaped connector 250 (also referred to as an "adapter") having a straight section 202 (e.g., a straight catheter) and at least one branch 204 (e.g., a branch catheter), but in some examples, it can include more than one branch. In some examples, a suture locking assembly 206 can be attached to the branch 204, and a sleeve handle (e.g., a sleeve actuation handle) 208 can be disposed at the proximal end of the straight section 202.

[0148] The hub assembly 230 can be adapted and configured to allow the proximal extension 290p of the pusher shaft 290 (or another similar pusher shaft) to extend to the suture locking assembly 206 disposed at the end of the branch 204, while the cutting portion 280p (which can also be referred to as the proximal portion) of the sleeve shaft 280 extends to the sleeve handle 208 disposed at the end of the straight section 202. With this configuration, a medical professional can perform a docking operation (e.g., a docking operation) by manipulating the position of the handle assembly 200 (e.g., moving it in the axial direction). Figure 4 The embodiment of the present invention is used to perform deployment of the docking device 232 of the implanted device, and also to perform retraction of the sleeve shaft 280 (away from and away from the implanted docking device) by pulling the sleeve handle 208 rearwardly in the axial direction.

[0149] In this way, the sleeve shaft 280 and the pusher shaft 290 can be configured to work together so that they can move together simultaneously when deploying and positioning the docking device at the native valve (e.g., by moving the entire hub assembly 230 forward and / or backward in the axial direction), and can also move independently so that the pusher shaft 290 can hold the docking device in place when the sleeve shaft 280 is retracted from the docking device (e.g., by holding the hub assembly 230 in place relative to the outer shaft 260 of the delivery device 220 and / or other portions of the delivery device 220 and / or the docking device while the sleeve handle 208 is pulled proximally to withdraw the sleeve shaft 280). As described herein, the sleeve shaft 280 and the pusher shaft 290 can be coaxial along part, all, or a majority of the delivery device 220 to facilitate this cooperative interaction.

[0150] like Figure 4-5 As shown in , the handle assembly 200 may also include one or more flushing ports to supply flushing fluid to one or more lumens disposed within the delivery device 220 (e.g., an annular lumen disposed between coaxial components of the delivery device 220) to reduce potential thrombosis. An example of a delivery device 220 including three flushing ports (e.g., flushing ports 210, 216, and 218) is shown in Figure 4 In an alternative example, the delivery device 220 may not include the flush port 216 (e.g., Figure 5 ).

[0151] Additional details regarding delivery systems and devices (e.g., delivery device 220) configured to deliver a docking device to a target implantation site can be found in U.S. Patent Publication Nos. US2018 / 0318079, US2018 / 0263764, and US2018 / 0177594, which are incorporated herein by reference in their entirety.

[0152] Additional details regarding the suture locking assembly and pusher shaft and sleeve shaft assembly of a delivery device for a docking device are described in International Patent Application Nos. PCT / US2020 / 36577 and PCT / US2021 / 056150.

[0153] Additional details regarding a handle assembly of a delivery device having one or more flushing ports configured to supply flushing fluid to one or more lumens disposed within the delivery device are described in International Patent Application Nos. PCT / US2020 / 36577 and PCT / US2021 / 059075.

[0154] Exemplary suture lock configured to be screwed onto an adapter

[0155] like Figure 4-5As shown in FIG. 1 and as described above, the delivery device 220 can include a suture locking assembly 206 located on the branch 204 of the hub assembly 230 of the handle assembly 200 . Figures 8A-9E An example of a ratcheting suture lock 270 is shown, which can be used as a Figure 4-5 The suture locking assembly 206 of the delivery device 220 of the embodiment of the present invention. As described below, the exemplary suture lock 270 includes a release knob 284 that can be screwed onto the end (e.g., 252) of the adapter 250.

[0156] and Figure 4-5 As with the system shown, a proximal extension (e.g., 290p) of the pusher shaft (e.g., 290) can extend to the suture lock 270 at the end of the branch 204, while the sleeve shaft (e.g., 280) can extend to the sleeve handle 208 at the end of the straight section 202. Fig. 8A As shown in FIG. 2 , the hub assembly 230 may include a flush port 216 configured to allow flushing of one or more lumens within the delivery device 220 to sterilize the delivery device 220 and / or maintain hemostasis within the delivery device.

[0157] and Figure 4-5 As with the system shown, a medical professional can deploy a docking device (e.g., 232) by manipulating the position of the handle assembly 200, and only add one additional step to retract the sleeve by pulling back the sleeve handle 208. The sleeve shaft (e.g., 280) and the pusher shaft (e.g., 290) can be configured to work together so that they can move together at the same time when the docking device is deployed and positioned at the native valve (e.g., by moving the entire hub assembly 230 and / or Y-shaped connector 250 forward and / or backward). In addition, the sleeve shaft and the pusher shaft can also be configured to move independently so that the pusher shaft can hold the docking device in place when the sleeve shaft is retracted from the docking device (e.g., by holding the hub assembly 230 and / or connector 250 in place relative to the outer shaft 260 and / or the delivery device 220 and / or other parts of the docking device when the sleeve handle 208 is pulled proximally to withdraw the sleeve shaft). As explained above, the sleeve shaft and pusher shaft can be coaxial along part, all, or a majority of the delivery device 220 to facilitate working together.

[0158] like Figures 8A-9B As shown in FIG. 1 , the suture lock 270 may include a rotator 272 (also referred to as a "rotatable handle") to increase and decrease the release suture 236 ( Figures 9B-9D ), the release suture may extend from the suture lock 270, through the branch 204, and through the handle 222 and the outer shaft 260 to connect to the docking device, as described above with reference to Figure 4 and Figure 7described.

[0159] In some examples, the release suture 236 can be wound around the spool 278 of the suture lock 270 (see, e.g., Figure 8C ). The rotator 272 can be coupled to the spool 278 such that rotating the rotator 272 in a given direction can adjust (e.g., increase or decrease) the tension on the release suture 236 passing through the delivery device 220. Providing tension or slack to the release suture 236 by rotating the rotator 272 (and therefore the spool 278) can move the docking device 232 closer to or further away from the delivery device 220, respectively.

[0160] like Figure 8B As shown in, in some examples, the rotator 272 may include one or more gripping portions or handles that increase the ease of gripping the rotator 272 (e.g., via the user's hand) without slipping. For example, the rotator 272 may include a first gripping portion 273 arranged around the circumference of the rotator 272, and the first gripping portion is configured to be gripped by the user during the rotation of the rotator 272. In some examples, the first gripping portion 273 may include a plurality of ridges to increase traction and ease of gripping. The rotator 272 may also include a second gripping portion 271 arranged on the top surface of the rotator 272. In addition, in some examples, the first gripping portion 273 and / or the second gripping portion 271 may include a material having a lower hardness count (e.g., reduced hardness).

[0161] In some examples, the suture lock 270 may also include a direction control mechanism, which may include a direction selector 274 (e.g., in the form of a switch, such as Figures 8A-8C ), the direction selector allows a practitioner or other user to select whether to increase or decrease the slack of the released suture 236 passing through the delivery device 220. For example, the direction selector 274 can be configured to allow a practitioner or other user to select a direction (e.g., increase or decrease tension), which will allow the rotator 272 to rotate in only one direction to prevent rotation in the wrong direction.

[0162] For example, Figure 8C As shown in , the spool 278 may include a gear 292 that may engage with a claw 294 that allows the gear 292 to rotate, and thus engage with the rotator 272 and the shaft 278 in only one direction. The direction in which the rotator 272 may rotate depends on the orientation of the claw 294, which is controlled by the direction selector 274. In some examples, such as Fig. 8A and 8CAs shown in , the top housing 262 may include a first icon 264 indicating a relaxed position of the direction selector 274 and a second icon 266 indicating a tension position of the direction selector 274 .

[0163] In some examples, the directional control mechanism can be a ratchet mechanism that limits directional movement of the rotator 272 by a medical practitioner or other user. Figure 8B and Figure 8C As shown in , gear 292 can be attached to rotator 272, and pawl 294 can be attached to direction selector 274. Pawl 294 can be designed to engage with teeth 291 of gear 292 so that gear 292 can only rotate in one direction at a time. When pawl 294 is actuated (e.g., pivoted) to a certain position (e.g., tensioned or relaxed), spring plunger 296 can engage the rear of pawl 294, thereby maintaining pawl 294 in the selected direction / position (e.g., tensioned or relaxed). Figure 8C ). When engaged in one direction, one or more teeth 298 of the pawl 294 can interact with the teeth 291 on the gear 292. In addition, a stop can be created to prevent the pawl 294 from moving in both directions, thereby allowing the gear 292 to move in only one direction. The stop can be constructed in a variety of ways, including making it part of the top housing 262 or by adding additional material (e.g., pins, spacers, etc.) inside the top housing 262 to prevent the pawl 294 from moving in both directions.

[0164] Additional details regarding the direction control mechanism of a suture lock (e.g., 270) are described in International Patent Application No. PCT / US2020 / 36577.

[0165] In some examples, the suture lock 270 may include a connector or connection portion for attaching the suture lock 270 to the handle assembly (e.g., 200). For example, the suture lock 270 may include a release rod 282 that extends into and is coupled to the bottom housing 268 of the suture lock 270 (see, e.g., Figures 8B-8C In some examples, release lever 282 can be coupled to bottom housing 268 (eg, via adhesive, welding, or other non-removable fixing means). Figure 8B and Figures 9A-9C As shown in FIG. 1 , the release knob 284 can be disposed around a portion of the release rod 282 near the connection portion 286 of the bottom housing 268. The release knob 284 can be configured to connect the suture lock 270 to the adapter 250 of the delivery device. Fig. 8AAs shown in FIG. 1 , the adapter 250 may include a branch 204 and a straight section 202. In the example shown, a release knob 284 may be screwed onto the end 252 of the adapter 250 to secure the suture lock 270 to the adapter 250. In some examples, the shape, size, and / or configuration of the adapter 250 may differ from Fig. 8A , and can vary based on the delivery device to which (and with which) the suture lock 270 is configured to be attached.

[0166] In some examples, when the teeth of the release knob 284 engage the end 252 of the adapter 250 (or another adapter of the delivery device) and the release rod 282, the suture lock 270 can be coupled to the delivery device and the suture cutting section 254 can be covered by the adapter 250 (see, e.g., Figures 8B-8C 9A-9E). In some examples, once the docking device (or other implant) is positioned in a desired location for release from the delivery device, the release knob 284 can be unscrewed toward the bottom housing 268, and the suture lock 270 can be pulled proximally away from the adapter 250 to reveal the suture cutting section 254. In alternative examples, rotation of the release knob 284 toward the bottom housing 268 can reveal the suture cutting section 254 without pulling the entire suture lock 270 away from the adapter 250.

[0167] The suture cutting section 254 can be configured to allow a user or medical practitioner to cut the suture across the length of the delivery device (e.g., Figure 4 and Figure 7 ) to allow the docking device to be disconnected from the delivery device when deployed at the target implantation site.

[0168] In some examples, once the suture 236 is released, it is wrapped around the docking device or implant (e.g., Figure 4 and Figure 7 ) and guided through the delivery device, through the release rod 282 (including through the suture cutting section 254, as shown in FIG. Fig. 9B ), and into the bottom housing 268, the two suture ends of the released suture 236 can pass through two orifices 279 arranged in the bottom end of the spool 278 (see, for example Figure 8C ), and then tied to complete the suture loop. In some examples, the spool 278 can include a gap 277 in the flange at the bottom of the spool 278, which can prevent the release suture 236 from being crushed during the assembly of the top shell 262 and the bottom shell 268.

[0169] In some examples, such as Fig. 8A As shown in , the rotator 272 may include an indicator 275 to track the number of rotations applied and locate the gap 277.

[0170] In some examples, such as Fig. 9C and Fig.9D As shown in FIG. 2 , the release suture 236 can be longitudinally extended through the release rod 282 of the suture lock 270, and the two lines of the release suture 236 (forming the suture loop) are separated to pass through the separator 256 disposed in the suture cutting section 254. The separator 256 can be configured to separate the two lines of the release suture 236 so that the user or medical practitioner can only cut one line to release the docking device from the delivery device. For example, as shown in FIG. Fig.9D , the exposed portion of the release suture 236 can then be cut by a cutting mechanism, such as a blade, scissors, etc. Once cut, the release suture 236 can be removed from the delivery device, and the suture lock 270 can be attached back to the adapter 250 of the delivery device, for example, by twisting the release knob 284 onto the adapter 250.

[0171] In some examples, a seal may be included within the suture lock 270, such as by using a plurality of annular sealing elements (e.g., O-rings) 258a-c to prevent leakage of blood, saline, or other fluids through the system. Figure 8C and Fig. 9C As shown in, the suture lock 270 may include a first distal release rod O-ring 258a, a second proximal release rod O-ring 258b, and a spool O-ring 258c. These O-rings 258a-c may be configured to seal the release suture path when the suture lock 270 is assembled, thereby allowing hemostasis when connected to a properly sealed delivery device. The spool O-ring 258c may be configured to prevent leakage through the end of the release suture path. The proximal release rod O-ring 258b may be configured to prevent leakage between the release rod 282 and the bottom housing 268. In some examples, this allows the adhesive or other adhesive that couples the release rod 282 to the bottom housing 268 to only act as a bond and does not require a sealing function. The distal release rod O-ring 258a may be configured to prevent leakage between the release rod 282 and the adapter 250 when the release knob 284 is engaged. The release knob 284 can be designed so that when there is any threaded engagement with the adapter 250, the distal release rod O-ring 258a seals the suture locking mechanism (e.g., there may not be a variable seal depending on how tight the release knob is). In some examples, there may be a hole in the bottom housing 268 to act as a leak path in the event of seal degradation.

[0172] like Fig. 9AAs shown in , the suture lock 270 may include a flush port 215 to allow flushing of one or more lumens within the delivery device, thereby reducing thrombosis between the components of the delivery device, maintaining hemostasis within the delivery device, and / or sterilizing the delivery device. In some cases, the flush port 215 can be configured to allow independent flushing of the lumen in the event of a single flush line obstruction and / or hemostasis not being maintained in the delivery device. In some cases, the flush port 215 can be an open port to allow constant flow through the delivery device. In some examples, the flush port 215 can be configured to be self-sealing so that fluid can be introduced into the delivery device by the practitioner as needed without the need for constant flow. Fig. 9A The flush port 215 shown in FIG. 1 allows connection to multiple flush ports (e.g., Figure 4 An additional flush line similar to the flush port shown in and discussed above.

[0173] In some examples, the suture lock 270 can have a keyed segment to prevent the suture lock 270 from rotating about the handle assembly, thereby preventing suture twisting and / or increasing ease of access by the practitioner. The keying of the suture lock 270 can be achieved in various ways, such as by creating a specific non-circular shape in the component, using pins, grooves, or any other method to maintain a non-rotating fit between the suture lock 270 and the housing or handle assembly. For example, as Fig. 9B As shown in , either end of the release lever 282 can be formed to form a first keyed connection 283a and a second keyed connection 283b, respectively, between the release lever 282 and the bottom housing 268 and between the release lever 282 and the adapter 250. For example, the proximal end 285 of the release lever 282 can be formed to form the first keyed connection 283a, and the distal end 287 of the release lever 282 can be formed to form the second keyed connection 283b.

[0174] In some examples, such as Fig.9D As shown in , the release lever 282 may include one or more support ribs 288 disposed on a central portion of the release lever 282 disposed between a distal end 287 and a proximal end 285 of the release lever 282. In some examples, the support ribs 288 may include a plurality of axially extending ribs 288 disposed around the circumference of the release lever 282 on either side of a central ring element 289 extending around the circumference of the release lever 282.

[0175] Exemplary Suture Locks Including Locking and Release Mechanisms

[0176] Figures 10A-10C A suture lock 300 is shown according to another example, which is configured to be releasably connected to an adapter 350 of a handle assembly (eg, 200). Specifically, Fig. 10A The suture lock 300 is shown locked to the adapter 350, Fig. 10B The suture lock 300 is shown unlocked and partially rotated relative to the adapter 350, and Fig. 10C The suture lock 300 is shown disconnected from the adapter 350. The suture lock 300 can be used as Figure 4-5 The suture locking assembly 206 of the delivery device 220 of the embodiment of the present invention is shown in FIG. 2. The adapter 350 can be similar to the Y-shaped connector 250 described above. For example, the adapter 350 can include a branch 354 and a straight section 356.

[0177] In the example shown, the suture lock 300 can be releasably connected to the adapter 350 via a locking and releasing mechanism 310 included in the connecting portion 306 of the bottom housing 308 of the suture lock 300 (similar to the connecting portion 286 of the bottom housing 268) and the end portions 352 of the branches 354 of the adapter 350. In other examples, the locking and releasing mechanism 310 can be included in other portions of the suture lock 300 and the adapter 350.

[0178] Using the locking and releasing mechanism 310, the suture lock 300 can be securely locked to the adapter 350 through an insertion step and then a rotation step. For example, the connecting portion 306 of the suture lock 300 can be inserted into the end portion 352 of the adapter 350, and then rotating the suture lock 300 relative to the adapter 350 by a partial turn (e.g., a quarter turn, a half turn, etc.) can securely lock the suture lock 300 to the adapter 350. Alternatively, the locking and releasing mechanism 310 can be configured to securely lock the suture lock 300 to the adapter 350 by inserting the end portion 352 of the adapter 350 into the lumen of the connecting portion 306 of the suture lock 300 and then rotating the suture lock 300 relative to the adapter 350.

[0179] In contrast, using the locking and releasing mechanism 310, the suture lock 300 can be easily unlocked from the adapter 350 by a rotation step followed by a pulling step. For example, to remove the suture lock 300 from the adapter 350, the user can grab the suture lock 300, rotate it a partial turn (e.g., a quarter turn, a half turn, etc.) relative to the adapter 350, and then pull it out of the adapter 350.

[0180] Thus, the steps involved in unlocking the suture lock 300 from the adapter 350 are in reverse order and opposite to the steps involved in locking the suture lock 300 to the adapter 350. For example, insertion (to lock) and pulling (to unlock) operate in opposite directions along the longitudinal axis (e.g., Fig. 10C 320), the longitudinal axis is coaxial with the connecting portion 306 of the suture lock 300 and the end portion 352 of the adapter 350. Similarly, the rotation directions of locking and unlocking are opposite directions (as shown in FIG. Fig. 10B 322), but the degree of rotation is approximately the same. For example, if the locking step involves a quarter turn in the clockwise direction when viewed from the suture lock 300, the unlocking step involves a quarter turn in the counterclockwise direction when viewed from the suture lock 300; or vice versa.

[0181] Optionally, a safety feature may be added (in addition to the locking and release mechanism 310) to increase the strength of the connection between the suture lock 300 and the adapter 350 when in the locked configuration and to prevent inadvertent unlocking. In some examples, the safety feature may be configured to fit through the transverse hole 380 (see, e.g., Figures 10B-10C ) of the locking pin 370 (see, for example, Fig. 10A and Fig. 10D ), the transverse hole extending through both the connecting portion 306 of the suture lock 300 and the end portion 352 of the adapter 350. The transverse hole 380 can include a first hole on the connecting portion 306 of the suture lock 300 and a second hole on the end portion 352 of the adapter 350. When the suture lock 300 is locked to the adapter 350, the first hole can be configured to align with the second hole to form the transverse hole 380.

[0182] In some examples, the locking pin 370 may include a pin portion 372 configured to be inserted into the transverse hole 380 and an enlarged head portion 374 having a larger diameter than the transverse hole 380. When the pin portion 372 is inserted into the transverse hole 380, the enlarged head portion 374 may be configured to remain outside the transverse hole 380 (see, e.g., Fig. 10A ) and is easily captured by users.

[0183] Inserting the locking pin 370 into the transverse hole 380 can enhance the lock between the suture lock 300 and the adapter 350 (provided by the locking and release mechanism 310) and prevent unintentional rotation of the suture lock 300 relative to the adapter 350. In order to unlock and remove the suture lock 300 from the adapter 350, the user needs to intentionally remove the locking pin 370 from the transverse hole 380 (see, e.g., Figures 10B-10C ).

[0184] As described herein, the suture lock 300 can be coupled to and / or released from the adapter 350 without operating the release knob (e.g., 284) described above. In some cases, the locking and release mechanism 310 described herein can be more accessible than the release knob. In addition, the locking and release mechanism 310 can reduce the risk of air embolism introduced, for example, by back-driving of the release knob in some cases. In addition, compared to the release knob (e.g., 284) that can be tightened to a variable degree, the locking and release mechanism 310 produces a discreet locking and unlocking configuration.

[0185] Representative examples of locking and release mechanisms 310 are described more fully below.

[0186] Exemplary Locking and Release Mechanisms Using Interference Fit

[0187] Figures 11A-11B A locking and release mechanism 410 is shown, which may be Figures 10A-10C An example of a locking and release mechanism 310 is shown in , by which a suture lock (eg, 300 ) may be connected to and / or disconnected from an adapter (eg, 350 ).

[0188] As described more fully below, the locking and release mechanism 410 is different from the traditional bayonet mechanism for releasably connecting two mating parts, wherein the nail on one of the mating parts can slide through the L-shaped groove and enter the incision area on the other mating part. The traditional bayonet mechanism needs to generate (for example, applied by a compression spring, a washer, etc.) tension or (for example, applied by a tension spring, a taut suture, etc.) compression between the groove and the nail to keep the nail in the incision area and prevent the rotational movement between the two mating parts. For example, if the two parts are tensioned and kept together, they must push against each other to overcome the tension force in order to achieve rotation. On the contrary, if the two parts are compressed and kept together, they must be pulled away from each other to overcome the compression force in order to achieve rotation. Although the release suture (for example 236) can also be used to generate compression, the release suture can not be relied on to continuously generate the compression used in the bayonet mechanism to lock / unlock between the suture lock and the adapter. For example, during the initial surgery of delivering a prosthetic implant (e.g., docking device 100 or 232) to a target implant site, when the release suture is pulled tight and taut, after the prosthetic implant is deployed, the release suture is cut loose and has slack. As a result, the release suture loses compression and the suture lock can be accidentally unlocked from the adapter. As described below, the locking and release mechanism 410 does not rely on compression or tension between the two mating parts to keep them in place. Instead, the locking and release mechanism 410 uses an interference fit mechanism to lock / unlock between the suture lock and the adapter.

[0189] like Fig.11A As shown in , the locking and release mechanism 410 may include a pin 412 (which may also be referred to as a "pin"), a slot 414 (which may also be referred to as a "track" or "channel"), and a retaining portion 416 connected to the slot 414. The pin 412 is configured to slide or travel through the slot 414 and be received / retained in the retaining portion 416. The size and shape of the retaining portion 416 can be configured to match the size and shape of the pin 412. In some examples, the retaining portion 416 can be considered an enlarged portion of the slot 414, and another portion of the slot 414 can be referred to as the "track portion" of the slot 414.

[0190] like Fig.11A As shown in , the nail 412 is located on the first component 430 and the groove 414 is located on the second component 450. In some examples, the first component 430 can be a suture lock (e.g., 300) and the second component 450 can be an adapter (e.g., 350). In this case, the nail 412 can be located on the connecting portion (e.g., 306) of the suture lock, and the groove 414 can be located on the end portion (e.g., 352) of the adapter. In addition, the first component 430 can include a spool (e.g., 278) configured to be connected to a release suture (e.g., 236), which extends through the inner hole (e.g., 456) of the second component 450 and is tied to the prosthetic implant (e.g., docking device 100 or 232). In some examples, the first component 430 can be an adapter (e.g., 350) and the second component 450 can be a suture lock (e.g., 300). In this case, the groove 414 can be located on the connecting portion (e.g., 306) of the suture lock, and the nail 412 can be located on the end portion (e.g., 352) of the adapter. Additionally, the second component 450 may include a spool (eg, 278) configured to connect to a release suture (eg, 236) that extends through the lumen of the first component 430 and is tied to a prosthetic implant (eg, docking device 100 or 232).

[0191] In the example shown, the first component 430 includes a male connection portion 432 having a body 434, and the nail 412 extends radially outward from the body 434. In some examples, the nail 412 can be formed as an integral part of the body 434. In some examples, the nail 412 can be prepared separately and then attached to the body 434, such as by heat molding, adhesives, press fit, etc. The second component 450 includes a female connection portion 452 configured to receive the male connection portion 432 of the first component 430. The female connection portion 452 has a wall 460. The inner surface 454 of the wall 460 defines an inner hole 456. The groove 414 can extend along the inner surface 454. The retaining portion 416 can be connected to the end of the groove 414 and can be sized and shaped to receive the nail 412. The groove 414 and / or the retaining portion 416 can be formed on the wall 460, such as by laser cutting, etching or other means, or can be added directly to the female connection portion 452 as a molded feature, can be machined, etc.

[0192] The first component 430 and the second component 450 can be configured to be movable between a locked configuration and a released (or unlocked) configuration. When in the locked configuration, the nail 412 is positioned in the retaining portion 416, and the groove 414 is configured to prevent the rotational movement of the male connecting portion 432 relative to the female connecting portion 452. When in the released configuration, the nail 412 is positioned in the groove 414.

[0193] In various examples, the first component 430 and the second component 450 can be moved to a locked configuration by inserting the body 434 into the inner bore 456 and rotating the male connection portion 432 relative to the female connection portion 452 in a first direction about the axial axis 402 of the body 434 by less than one rotation. When the first component 430 is connected to the second component 450, the body 434 and the inner bore 456 are coaxial (i.e., they have a common axis 402).

[0194] When in the locked configuration, the first and second components 430, 450 can be moved to the released configuration by rotating the male connection portion 432 relative to the female connection portion 452 less than one rotation about the axial axis 402 of the body 434 in a second direction opposite to the first direction. The body 434 can then be pulled away from the inner bore 456.

[0195] When viewed from the first component 430, the first direction may be clockwise or counterclockwise. As described herein, a rotation of less than one resolution may correspond to a rotation between 10 and 350 degrees, or between 45 and 315 degrees, or between 90 and 180 degrees (including the above values). In one specific example, the rotation may be a quarter turn, such as about 90 degrees. In another specific example, the rotation may be an eighth turn, such as about 45 degrees.

[0196] like Fig.11A As shown in the figure, the groove 414 may include an axial portion 418 (also referred to as a "first groove portion" or a "first track portion") extending parallel to the axial axis 402 and a circumferential portion 420 (also referred to as a "second groove portion" or a "second track portion"), which is connected to the axial portion 418 at the corner 424 and extends circumferentially around the axial axis 402.

[0197] In the example shown, the retaining portion 416 is connected to the end of the peripheral portion 420. As shown, the peripheral portion 420 can include an end portion 422 adjacent to the retaining portion 416. In some examples, the peripheral portion 420 can have a tapered shape so that the diameter of the peripheral portion 420 can gradually decrease from the corner 424 to the end portion 422 and / or the retaining portion 416.

[0198] In some examples, the retaining portion 416 can be a cutout extending radially through the wall 460, so that the pin 412 received in the retaining portion 416 can be exposed through the cutout, thereby providing a visual confirmation that the first component 430 and the second component 450 are in a locked configuration. In some examples, the pin 412 received in the retaining portion 416 can extend radially outward beyond the outer surface 464 of the wall 460 (see, e.g., Fig. 11B ) so that the wall 460 can prevent the nail 412 from accidentally sliding out of the retaining portion 416.

[0199] In some examples, the circumferential portion 420 may include a cutout window 426 (e.g., formed by laser cutting, etc.) that extends radially through the wall 460 of the female connecting portion 452 to expose the staples 412 when the staples 412 are moved into the cutout windows 426. In some examples, the cutout windows 426 may include an end portion 422. For example, the cutout windows 426 may extend from the retaining portion 416 to a cutout edge 428 spaced apart from the corner 424.

[0200] According to some examples, the end portion 422 can be deflectable. Therefore, the end portion 422 can also be referred to as a "deflectable portion". When the nail 412 is not inserted into the end portion 422, the end portion 422 can have a smaller diameter than the nail 412. However, when the nail 412 is received in the end portion 422, the end portion 422 can be enlarged by the nail 412. Therefore, the nail 412 can form an interference fit with the end portion 422, and an external force (e.g., by rotating the male connection portion 432 relative to the female connection portion 452) can push the nail 412 to slide through the end portion 422 of the slot 414.

[0201] To lock the first component 430 to the second component 450, the male connection portion 432 can be inserted into the female connection portion 452 so that the nail 412 can slide through the axial portion 418 of the slot 414. After reaching the corner 424, the male connection portion 432 can be rotated relative to the female connection portion 452 so that the nail 412 can slide through the circumferential portion 420 (the end portion 422 is enlarged to accommodate the sliding nail 412) and into the retaining portion 416. Because the end portion 422 has a smaller diameter than the nail 412, once the nail 412 is received in the retaining portion 416, the end portion 422 will prevent the nail 412 from being removed from the retaining portion 416. Therefore, the male connection portion 432 will be inhibited from rotating relative to the female connection portion 452 (i.e., locked).

[0202] In order to unlock the first component 430 from the second component 450, the male connecting portion 432 can be rotated relative to the female connecting portion 452 (in the opposite direction of the locking operation) so that a sufficiently large external force can cause the nail 412 to leave the retaining portion 416 and enter the circumferential portion 420 (i.e., be unlocked), for example by expanding and overcoming the resistance applied by the end portion 422.

[0203] In some examples, the female connection portion 452 can include at least one release channel 458 extending parallel to the circumferential portion 420 and configured to allow the end portion 422 to expand axially as the staple 412 moves through the end portion 422. The release channel 458 can be a cutout (e.g., formed by laser cutting, etc., and / or added directly as a molded feature, machined, etc.) extending radially through the wall 460 of the female connection portion 452, and the void space in the release channel 458 allows the material surrounding the end portion 422 to flex during the insertion of the staple 412 into the end portion 422. In some examples, the circumferential length of the release channel 458 can be substantially the same as or greater than the circumferential length of the cutout window 426.

[0204] exist Fig.11A In the example shown, two release channels 458 of substantially the same size and shape are symmetrically positioned on either side of the end portion 422. In other examples, the two release channels 458 may have different sizes and / or shapes and may be asymmetrically positioned around the end portion 422. In still other examples, there may be only one release channel or more than two release channels 458 around the end portion 422.

[0205] In place of or in addition to the release channel 458, the wall 460 of the female connecting portion 452 may include a deformable material (e.g., rubber, copper, aluminum, nickel-titanium alloy, magnesium alloy, etc.) surrounding the end portion 422, such that when the nail 412 moves through the end portion 422, the nail 412 may compress the deformable material and cause the end portion 422 to expand axially.

[0206] According to some examples, nail 412 can be self-expanding. For example, nail 412 can be movable between a compressed state and an expanded state, and is configured to be biased toward the expanded state. For example, when no external force is applied, nail 412 can remain in the expanded state. When a squeeze force is applied to nail 412, nail 412 can move to a compressed state and return to the expanded state when the squeeze force is removed. The diameter of nail 412 in the expanded state can be greater than the diameter in the compressed state. Various techniques can be used to design such self-expanding nails 412, such as using self-expanding materials (e.g., rubber, nickel-titanium alloy, etc.) and / or structural configurations (e.g., coils, springs, etc.).

[0207] In some examples, the retaining portion 416 can be configured to retain the nail 412 in an expanded state, and the groove 414 can be configured to receive the nail 412 in a compressed state. For example, the retaining portion 416 can have a diameter that matches the diameter of the nail 412 in the expanded state. In one example, the groove 414 can have a substantially constant diameter that matches the diameter of the nail 412 in the compressed state. In another example, the diameter of the groove 414 can vary (for example, the diameter of the axial portion 418 can be greater than the diameter of the circumferential portion), and at least the end portion 422 can have a diameter that matches the diameter of the nail 412 in the compressed state. Therefore, the nail 412 can be press-fit into the end portion 422 of the groove 414, and an external force (for example, by rotating the male connection portion 432 relative to the female connection portion 452) can push the nail 412 (in a compressed state) through the groove 414.

[0208] Similarly, to lock the first component 430 to the second component 450, the male connection portion 432 can be inserted into the female connection portion 452 so that the nail 412 can slide through the axial portion 418 of the slot 414. After reaching the corner 424, the male connection portion 432 can be rotated relative to the female connection portion 452 so that the nail 412 can slide through the circumferential portion 420 (the nail 412 is squeezed into a compressed state in the end portion 422) and enter the retaining portion 416. Once the nail 412 is received in the retaining portion 416, the nail 412 can return to the expanded state. Therefore, the narrower end portion 422 will prevent the expanded nail 412 from moving out of the retaining portion 416. Therefore, the male connection portion 432 will be inhibited from rotating relative to the female connection portion 452 (i.e., locked).

[0209] In order to unlock the first component 430 from the second component 450, the male connection portion 432 can be rotated relative to the female connection portion 452 (in the opposite direction of the locking operation) so that a sufficiently large external force can cause the nail 412 to leave the retaining portion 416 and enter the circumferential portion 420 (i.e., be unlocked), for example by compressing the nail 412 and press-fitting the nail 412 into the end portion 422.

[0210] Figures 12A-12B A locking and release mechanism 510 is shown, which may be Figures 10A-10C , a suture lock (e.g., 300) can be connected to and / or disconnected from an adapter (e.g., 350) by a locking and releasing mechanism. Similar to 410, a locking and releasing mechanism 510 uses an interference fit mechanism to lock / unlock between a suture lock and an adapter.

[0211] like Fig. 12AAs shown in , the locking and release mechanism 510 may include a pin 512, a slot 514, and a retaining portion 516 connected to the slot 514. The pin 512 is configured to slide or travel through the slot 514 and be received / retained in the retaining portion 516. The size and shape of the retaining portion 516 can be configured to match the size and shape of the pin 512. In some examples, the retaining portion 516 can be considered an enlarged portion of the slot 514.

[0212] like Fig. 12A As shown in , the nail 512 is located on the first component 550 and the groove 514 is located on the second component 530. In some examples, the first component 550 can be a suture lock (e.g., 300) and the second component 530 can be an adapter (e.g., 350). In this case, the nail 512 can be located on the connecting portion (e.g., 306) of the suture lock, and the groove 514 can be located on the end portion (e.g., 352) of the adapter. In addition, the first component 550 can include a spool (e.g., 278) configured to be connected to a release suture (e.g., 236) that extends through the lumen of the second component 530 and is tied to the prosthetic implant (e.g., docking device 100 or 232). In some examples, the first component 550 can be an adapter (e.g., 350) and the second component 530 can be a suture lock (e.g., 300). In this case, the groove 514 can be located on the connecting portion (e.g., 306) of the suture lock, and the nail 512 can be located on the end portion (e.g., 352) of the adapter. Additionally, the second component 530 can include a spool (e.g., 278) configured to connect to a release suture (e.g., 236) that extends through an inner bore (e.g., 556) of the first component 550 and is tied to a prosthetic implant (e.g., docking device 100 or 232).

[0213] In the example shown, the first component 550 includes a female connection portion 552. The female connection portion 552 has a wall 560. The inner surface 554 of the wall 560 defines an inner hole 556. The nail 512 extends radially inward from the inner surface 554 (i.e., extends from the wall 560 into the inner hole 556). The second component 530 includes a male connection portion 532 configured to be inserted into the inner hole 556 of the female connection portion 552. The male connection portion 532 has an outer surface 564. The groove 514 can extend along the outer surface 564, and the retaining portion 516 can be connected to the groove 514 and configured to receive the nail 512. The male connection portion 532 and the female connection portion 552 can share a common axial axis 502 when connected.

[0214] Similarly, the first component 550 and the second component 530 can be configured to be movable between a locked configuration and a released (or unlocked) configuration. When in the locked configuration, the nail 512 is positioned in the retaining portion 516, and the groove 514 is configured to prevent the rotational movement of the male connecting portion 532 relative to the female connecting portion 552. When in the released configuration, the nail 512 is positioned in the groove 514.

[0215] Unlike the locking and releasing mechanism 410, in which the pins 412 extend radially outward from the male connecting portion 432 and are received in the slots 414 and / or the retaining portions 416 located on the female connecting portion 452, the locking and releasing mechanism 510 reverses the pin-slot configuration. That is, the pins 512 extend radially inward from the female connecting portion 552 and are received in the slots 514 and / or the retaining portions 516 located on the male connecting portion 532. Despite this difference, the locking and releasing mechanism 510 can lock / unlock between the first component 550 and the second component 530 in a manner similar to the locking and releasing mechanism 410 described above that locks / unlocks between the first component 430 and the second component 450.

[0216] For example, the first component 550 and the second component 530 can be moved to the locked configuration by inserting the male connection portion 532 into the inner hole 556 and rotating the male connection portion 532 less than one rotation in a first direction about the axial axis 502 relative to the female connection portion 552. Similarly, when in the locked configuration, the first component 550 and the second component 530 can be moved to the released configuration by rotating the male connection portion 532 less than one rotation in a second direction opposite to the first direction about the axial axis 502 relative to the female connection portion 552.

[0217] The spike 512, the slot 514, and the retaining portion 516 can have the same shape and / or size (and be formed / produced in the same manner) as the spike 412, the slot 414, and the retaining portion 416, respectively. For example, the slot 514 can have an axial portion 518 extending parallel to the axial axis 502 and a circumferential portion 520 connected to the axial portion 518 at a corner 524 and extending circumferentially around the axial axis 502. The retaining portion 516 can be connected to the end of the circumferential portion 520. The circumferential portion 520 may include an end portion 522 adjacent to the retaining portion 516. In some examples, the circumferential portion 520 can have a tapered shape so that the diameter of the circumferential portion 520 can gradually decrease from the corner 524 to the end portion 522 and / or the retaining portion 516.

[0218] Similar to 422, the end portion 522 can be deflectable. When the nail 512 is not inserted into the end portion 522, the end portion 522 can have a smaller diameter than the nail 512. However, when the nail 512 is received in the end portion 522, the end portion 522 can be enlarged by the nail 512. Therefore, the nail 512 can form an interference fit with the end portion 522, and an external force (e.g., by rotating the male connecting portion 532 relative to the female connecting portion 552) can push the nail 512 to slide through the end portion 522 of the slot 514. Similarly, the deflectable end portion 522 can be achieved by having one or more release channels 558 (similar to 458) around the circumferential portion 520 and / or using a deformable material around the end portion 522.

[0219] Alternatively, similar to 412, the nail 512 can be movable between a compressed state and an expanded state and configured to be biased toward the expanded state. The retaining portion 516 can be configured to retain the nail 512 in the expanded state, and the slot 514 can be configured to receive the nail 512 in the compressed state (e.g., the end portion 522 can have a diameter that matches the diameter of the nail 512 in the compressed state). Therefore, the nail 512 can be press-fit into the end portion 522 of the slot 514, and an external force (e.g., by rotating the male connection portion 532 relative to the female connection portion 552) can push the nail 512 (in the compressed state) through the slot 514.

[0220] According to some examples, the suture lock (e.g., 300) can be connected to and / or disconnected from an adapter (e.g., 350) by more than one locking and releasing mechanism 410 or 510 having the same or similar staple-slot configuration. Using multiple locking and releasing mechanisms can increase the strength and alignment of the engagement between the suture lock and the adapter.

[0221] As an example, when the connecting portion (e.g., 306) of the suture lock is connected to the end portion (e.g., 352) of the adapter, the suture lock and the adapter can be releasably connected to each other by two locking and releasing mechanisms in diametrically opposed positions. In other examples, more than two locking and releasing mechanisms (e.g., 410 or 510) can be used to releasably connect the suture lock to the adapter. For example, when the connecting portion of the suture lock is connected to the end portion of the adapter, the multiple locking and releasing mechanisms can be configured to be circumferentially equidistant.

[0222] When multiple locking and releasing mechanisms 410 or 510 are used to lock / unlock between the suture locker and the adapter, the nails and slots (and the retaining portion) can be arranged in various ways. In one example, the nail of each locking and releasing mechanism can be located on the connecting portion (e.g., 306) of the suture lock, and the slot of each locking and releasing mechanism can be located on the end portion (e.g., 352) of the adapter. In another example, the slot of each locking and releasing mechanism can be located on the connecting portion of the suture lock, and the nail of each locking and releasing mechanism can be located on the end portion of the adapter. In yet another alternative example, the nails of some locking and releasing mechanisms can be located on the connecting portion of the suture lock, and their corresponding slots can be located on the end portion of the adapter, while the nails of other locking and releasing mechanisms can be located on the end portion of the adapter and their corresponding slots can be located on the connecting portion of the suture lock.

[0223] Example locking and release mechanism including a detent

[0224] Fig.13 A locking and release mechanism 610 is shown, which may be Figures 10A-10C , a suture lock (e.g., 300) can be connected to and / or disconnected from an adapter (e.g., 350) by a locking and releasing mechanism. As described below, the locking and releasing mechanism 610 does not rely on compression or tension between the suture lock and the adapter to hold them in place. Instead, the locking and releasing mechanism 610 uses a stop into which a nail or pin can snap fit to lock / unlock between the suture lock and the adapter.

[0225] Fig.13 A first component 630 and a second component 650 are shown that can be releasably connected to each other via a locking and release mechanism 610. When connected, at least the connected portions of the first component 630 and the second component can share a common axial axis 602. In some examples, the first component 630 can be a suture lock (e.g., 300) and the second component 650 can be an adapter (e.g., 350). In other examples, the second component 650 can be a suture lock (e.g., 300) and the first component 630 can be an adapter.

[0226] like Fig.13 As shown in FIG. 1 , the locking and release mechanism 610 includes a first locking mechanism 620 and a second locking mechanism 640. The first locking mechanism 620 may include a first nail 622 and a first slot 624 configured to receive the first nail 622. The second locking mechanism 640 may include a second nail 642 and a second slot 644 configured to receive the second nail 642. The first nail 622 and the second nail 642 may have the same or different shapes and / or sizes.

[0227] In the example shown, the first nail 622 and the second nail 642 are both located on the first part 630, and the first slot 624 and the second slot 644 are both located on the second part 650. In another example, the first nail 622 and the second nail 642 can both be located on the second part 650, and the first slot 624 and the second slot 644 can both be located on the first part 630. In yet another alternative example, one of the nails (e.g., 622 or 642) can be located on the first part 630, and the other nail can be located on the second part 650. Correspondingly, one of the slots (e.g., 624 or 644) can be located on the second part 650, and the other slot can be located on the first part 630.

[0228] For example, the first component 630 may have a male portion configured to be inserted into the inner hole of the second component 650. In one example, two pins 622, 642 may extend radially outward from the male portion of the first component 630, and two grooves 624, 644 may extend along the inner surface defining the inner hole of the second component 650 (similar to Fig.11A In another example, the two pins 622, 642 may extend radially inward from the inner surface of the second component 650, and the two grooves may extend along the outer surface of the male portion of the first component 630 (similar to the arrangement of the pins 412 and the grooves 414 shown in FIG. 1 ). Fig. 12A 512 and slot 514 are shown in FIG. 5 ). In yet another example, one of the pins (e.g., 622, 642) can extend radially outward from the male portion of the first component 630, and the other pin can extend radially inward from the inner surface of the second component 650. Accordingly, one of the slots (e.g., 624, 644) can extend along the inner surface of the second component 650, and the other slot can extend along the outer surface of the first component 630.

[0229] Alternatively, the first component 630 may have an inner hole configured to receive the male portion of the second component 650. Similarly, one or two pins 622, 642 may extend radially outward from the male portion of the second component 650 or radially inward from the inner surface defining the inner hole of the first component 630. Accordingly, one or two slots 624, 644 may extend along the inner surface of the first component 630 or the outer surface of the male portion of the second component 650.

[0230] like Fig.13As shown in , the first slot 624 may include an axial portion 626 extending parallel to the axial axis 602 and a circumferential portion 628 connected to the axial portion 626 at a corner 632 and extending circumferentially around the axial axis 602. Therefore, when the first nail 622 is received in the circumferential portion 628 of the first slot 624 (and positioned away from the corner 632), the first component 630 may be rotatable but not axially movable (i.e., axially locked) relative to the second component 650. On the other hand, when the first nail 622 is received in the axial portion 626 of the first slot 624, the first component 630 may be axially movable (i.e., axially unlocked) relative to the second component 650. In other words, by moving the position of the first nail 622 in the first slot 624, the first locking mechanism 620 may lock / unlock the axial movement between the first component 630 and the second component 650.

[0231] As shown, the second slot 644 can extend circumferentially around the axial axis 602 and have a first end P1 and a second end P2. The second locking mechanism 640 can include a radially recessed stop 646 connected to the second slot 644 and configured to retain the second nail 642. In some examples, the stop 646 can be formed as a portion of the second slot 644. As described below, when the first nail 622 is received in the circumferential portion 628 of the first slot 624, the rotation of the first component 630 relative to the second component 650 can move the second nail 642 through the second slot 644 until the second nail 642 snaps into the stop 646 so that the second slot 644 can inhibit the second nail 642 from moving out of the stop 646.

[0232] In some examples, the second groove 644 is configured to be radially offset from the circumferential portion 628 of the first groove 624 by a distance (d) that is approximately the same as the length of the axial portion 626 of the first groove 624, such that when the first nail 622 is received in the first groove 624 at the corner 632, the second nail 642 can be received in the second groove 644, for example at an initial position P0 that is circumferentially spaced from the stop portion 646.

[0233] In addition, the circumferential path 647 connecting the stop 646 and the initial position P0 extends from the initial position P0 in the same angular direction (e.g., clockwise or counterclockwise) as the circumferential portion 628 extends from the corner 632. Therefore, when the first nail 622 is received in the first groove 624 at the corner 632, the rotation of the first component 630 relative to the second component 650 can simultaneously move the first nail 622 into the circumferential portion 628 (thereby being axially locked) and move the second nail 642 along the circumferential path 647 toward the stop 646.

[0234] In some examples, the initial position P0 can be located at the first end P1 of the second slot 644. In other examples, the initial position P0 can be located in the middle portion of the second slot 644. In some examples, the circumferential length between the initial position P0 and the stopper 646 is substantially the same as the circumferential length of the circumferential portion 628. Therefore, when the first nail 622 moves to the end 634 of the circumferential portion 628, the second nail 642 can move into the stopper 646. In other examples, the circumferential length between the initial position P0 and the stopper 646 can be less than the circumferential length of the circumferential portion 628.

[0235] Fig.14A An example is shown in which the second groove 644 extends along the outer surface 604 of the component, which may be the first component 630 or the second component 650. In this example, the second groove 644 is recessed radially inward from the outer surface 604, and the stopper 646 is further recessed radially inward from the second groove 644 and the outer surface 604. In other words, the stopper 646 forms a deeper recess or pit extending radially inward from the outer surface 604 than the second groove 644. In the example shown, the stopper 646 is located at the second end P2 of the second groove 644 (i.e., the stopper 646 is located between the second groove 644 and the non-recessed outer surface 604). In other examples, the stopper 646 may be located in the middle portion of the second groove 644 (i.e., the stopper 646 is spaced apart from the non-recessed outer surface 604).

[0236] like Fig.14A As shown in , the second nail 642 can be configured to move across the second slot 644, then fall into the stop 646 and snap fit into the stop, for example, by rotating the first component 630 relative to the second component 650 in the first direction 612. In some examples, the second nail 642 can be movable between a radially biased position and a radially non-biased position. Specifically, the second nail 642 received in the second slot 644 can be in a radially biased position, and the second nail 642 received in the stop 646 can be in a radially non-biased position. Therefore, when the second nail 642 moves from the second slot 644 to the stop 646, it can return from the radially biased position to the radially non-biased position.

[0237] Once retained in the stop 646, the second pin 642 can be inhibited from moving out of the stop 646 (due to the resistance exerted by the wall 645 around the stop 646), thereby resisting the rotational movement of the first component 630 relative to the second component 650 (i.e., being rotationally locked). On the other hand, the first component 630 can be rotated relative to the second component 650 in the second direction 614 opposite to the first direction 612 using a sufficiently large external force to overcome the resistance of the wall 645 and cause the second pin 642 to leave the stop 646 and enter the second groove 644, thereby enabling the first component 630 to rotate relative to the second component 650 (i.e., being rotationally unlocked). In other words, by moving the position of the second pin 642 within the second groove 644 and / or the stop 646, the second locking mechanism 640 can lock / unlock the rotational movement between the first component 630 and the second component 650.

[0238] like Fig.14A As shown in , in some examples, the second groove 644 can have a radial protrusion 648 adjacent to the stop 646. The radial protrusion 648 can extend radially outward from the remainder of the second groove 644. In a specific example, the radial protrusion 648 can be configured to have the same radius as the outer surface 604. In other examples, the radial protrusion 648 can have a smaller or larger radius than the outer surface 604. Having the radial protrusion 648 adjacent to the stop 646 can increase the radial depth of the stop 646 (i.e., increase the height of the wall 645 that separates the stop 646 from the second groove 644), thereby requiring a greater external force to overcome the resistance of the wall 645 to unlock the rotational movement between the first component 630 and the second component 650.

[0239] In some examples, the radial protrusion 648 can be configured to be radially compressible so that the radial protrusion 648 can be radially compressed by the second nail 642 and allow the second nail 642 to move across the radial protrusion 648. For example, the radial protrusion can include a deformable material (e.g., rubber, copper, aluminum, nickel titanium alloy, magnesium alloy, etc.). Additionally or alternatively, the second locking mechanism 640 can include one or more release channels, which are located below the radial protrusion 648 and are configured to allow the radial protrusion 648 to be radially compressed when the second nail 642 moves across the radial protrusion 648.

[0240] In some examples, the radial protrusion 648 can be configured to be non-pressable. In contrast, the second nail 642 can be configured to be radially pressable or circumferentially deflectable. For example, the second nail 642 can include a deformable or deflectable material (e.g., rubber, copper, aluminum, nickel-titanium alloy, magnesium alloy, etc.), and / or have a coil or spring structure that allows it to be radially deformed and / or circumferentially deflected by the radial protrusion 648 when moving across the radial protrusion 648.

[0241] Fig. 14B Another example is shown in which the second groove 644 extends along the inner surface 606 of the component, which may be the first component 630 or the second component 650. In this example, the second groove 644 is recessed radially outward from the inner surface 606, and the stopper 646 is further recessed radially outward from the second groove 644 and the inner surface 606. In other words, the stopper 646 forms a deeper recess or pit extending radially outward from the inner surface 606 than the second groove 644. In the example shown, the stopper 646 is located at the second end P2 of the second groove 644 (i.e., the stopper 646 is located between the second groove 644 and the non-recessed inner surface 606). In other examples, the stopper 646 may be located in the middle portion of the second groove 644 (i.e., the stopper 646 is spaced apart from the non-recessed inner surface 606).

[0242] Similar to Fig.14A , the second spike 642 can be configured to rotationally lock the first component 630 to the second component 650 by rotating the first component 630 relative to the second component 650 in the first direction 616, moving across the second slot 644, and then snap-fitting into the stop 646. Similarly, by rotating the first component 630 relative to the second component 650 in a second direction 618 opposite to the first direction 616, and using a sufficiently large external force, the second spike 642 can move out of the stop 646 and into the second slot 644, thereby rotationally unlocking the first component 630 from the second component 650.

[0243] Similarly, if Fig. 14B , the second groove 644 can have a radial protrusion 648 adjacent to the stop 646. The radial protrusion 648 can extend radially inward from the rest of the second groove 644 to form a deeper wall around the stop 646. In a specific example, the radial protrusion 648 can be configured to have the same radius as the inner surface 606. In other examples, the radial protrusion 648 can have a smaller or larger radius than the inner surface 606. Similarly, the radial protrusion 648 can be configured to be radially compressible so that when the second nail 642 is moved across the radial protrusion 648, the radial protrusion 648 can be radially compressed by the second nail 642. Additionally or alternatively, the second nail 642 can be configured to be radially compressible or circumferentially deflectable so that when moving across the radial protrusion 648, the second nail 642 can be radially deformed and / or circumferentially deflected by the radial protrusion 648.

[0244] In some examples, such as Fig.13As shown in , the first locking mechanism 620 may optionally include a third nail 662 and a third groove 664 configured to receive the third nail 662. In the example shown, the third nail 662 is located on the first component 630 and the third groove 664 is located on the second component 650. Alternatively, the third nail 662 can be located on the second component 650 and the third groove 664 can be located on the first component 630. Similar to the first nail 622 and the second nail 642, depending on whether the component on which the third nail is located has a male portion configured to be inserted into the inner hole of another component or has an inner hole configured to receive the male portion of another component, the third nail 662 can extend radially outward from the outer surface or radially inward from the inner surface. Accordingly, the third groove 664 can extend along the inner surface or outer surface of the first component or the second component.

[0245] The third slot 664 can have a similar configuration as the first slot 624. For example, the third slot 664 can include an axial portion 666 extending parallel to the axial axis 602 and a circumferential portion 668 connected to the axial portion 666 at the corner 636 and extending circumferentially around the axial axis 602. In some examples, the axial portion 666 of the third slot 664 can have substantially the same length as the axial portion 626 of the first slot 624, such that the circumferential portion 668 of the third slot 664 is axially aligned with the circumferential portion 628 of the first slot 624. Thus, when the first nail 622 is received in the first slot 624 at the corner 632 (and the second nail 642 is received in the second slot 644), the third nail 662 is also received in the third slot 664 at the corner 636.

[0246] As shown, when the first component 630 is connected to the second component 650, the second slot 644 can be configured to be positioned between the first slot 624 and the third slot 664. Similarly, the first nail 622 and the third nail 662 can be positioned at circumferentially opposite sides of the second nail 642. In some examples, the positions of the first nail 622 and the third slot 662 can be symmetrical about the second nail 642. In other examples, the positions of the first nail 622 and the third slot 662 can be asymmetrical about the second nail 642.

[0247] In some examples, the first nail 622 and the third nail 662 can have different sizes. Fig.13As shown in , the first nail 622 can have a larger width or diameter (measured perpendicular to the axial axis 602) than the third nail 662 (or vice versa). The axial portion 666 of the third groove 664 can have approximately the same width or diameter as the third nail 662, and the axial portion 626 of the first groove 624 can have approximately the same width or diameter as the first nail 622. Therefore, the axial portion 666 of the third groove 664 can have a smaller width or diameter than the axial portion 626 of the first groove 624. Therefore, the asymmetric size of the first nail 622 and the third nail 662 (and the asymmetric size of the axial portions 666, 626) can prevent the first nail 622 from being accidentally inserted into the axial portion 666 of the third groove 664 (or vice versa). On the other hand, other dimensions of the first nail 622 and the third nail 662 (e.g., the height measured along the axial axis 602) can be the same or different. Thus, the width or diameter of the circumferential portion 628 of the first slot 624 and the circumferential portion 668 of the third slot 664 may be the same or different.

[0248] In some examples, the first nail 622 and the third nail 662 can have different shapes. Fig.13 As shown in , the first nail 622 can have a rectangular cross section, and the third nail 662 can have a square cross section. In other examples, the cross sections of the first nail 622 and the third nail 662 can have other shapes, such as circular, oval, triangular, hexagonal, etc.

[0249] In other examples, the first spike 622 and the third spike 662 may have substantially the same shape and size.

[0250] In some examples, the first locking mechanism 620 and the second locking mechanism 640 define a locking group, and the locking and releasing mechanism 610 may include a plurality of locking groups. For example, the first component 630 and the second component 650 may be releasably connected to each other by two locking groups in diametrically opposed positions.

[0251] Fig.15 A locking and release mechanism 710 is shown, which may be Figures 10A-10C As another example of a locking and release mechanism 310 shown in FIG. 7 , a first component 730 (eg, a suture lock or an adapter) and a second component 750 (eg, an adapter or a suture lock) may be releasably connected to one another via a locking and release mechanism.

[0252] Similar to 610, the locking and releasing mechanism 710 includes a first locking mechanism 720 and a second locking mechanism 740. The second locking mechanism 740 may be configured as described above with reference to Fig.13 and Figures 14A-14BThe second locking mechanism 640 described above is the same. For example, the second locking mechanism 740 may include a second pin 742, a second slot 744 configured to receive the second pin 742, and a radially recessed stop 746 connected to the second slot 744. The second pin 742 may be configured to snap fit within the stop 746. Therefore, similar to 640, the second locking mechanism 740 may lock / unlock the rotational movement between the first component 730 and the second component 750 around the axial axis 702 of the first component 730 and the second component 750.

[0253] Similar to 620, the first locking mechanism 720 may include a first pin 722 and a first slot 724 configured to receive the first pin 722, and the first slot 724 may include an axial portion 726 and a circumferential portion 728 connected to the axial portion 726 at a corner 732. Likewise, by moving the position of the first pin 722 within the first slot 724, the first locking mechanism 720 may lock / unlock the axial movement between the first component 730 and the second component 750.

[0254] The relative positions and orientations of the first and second pins 722 and 742 and the first and second slots 724 and 744 may be configured to correspond to Fig.13 Therefore, when the first nail 722 is received in the first slot 724 at the corner 732, the second nail 742 can be received in the second slot 744.

[0255] Different from 620, such as Fig.15 As shown in , the first locking mechanism 720 can also include a retaining portion 770 connected to the end 734 of the circumferential portion 728 and configured to retain the first nail 722. In some examples, the first nail 722 can be configured to be retained in the retaining portion 770 when the second nail 742 is snap-fitted into the stop 746.

[0256] In some examples, the first pin 722, the first slot 724, and the retaining portion 770 can be configured similarly to the above reference Fig.11A (or Fig. 12A ) The nail 412 (or 512), the groove 414 (or 514) and the retaining portion 416 (or 516) are described in detail. Therefore, in addition to axial locking / unlocking, the first locking mechanism 720 can also provide additional functions and thus further enhance the rotational locking / unlocking provided by the second locking mechanism 740.

[0257] For example, the circumferential portion 728 may include an end portion 772 adjacent to the retaining portion 770. The retaining portion 770 may have a larger diameter and / or cross-sectional area than the end 734 and the end portion 772, and the first spike 722 may form an interference fit with the end portion 772. In some examples, the circumferential portion 728 may have a tapered shape such that the diameter of the circumferential portion 728 may gradually decrease from the corner 732 to the end 734 and / or the retaining portion 770.

[0258] Similar to 422 and 522 described above, the end portion 772 can be deflectable (e.g., by incorporating one or more release channels around the end portion 772 and / or using a deformable material around the end portion 772) so that the end portion 772 can be expanded when the first nail 722 is pushed through the end portion 772 (e.g., by rotating the first component 730 relative to the second component 750).

[0259] Alternatively, similar to 412 and 512, the first spike 722 can be movable between a biased compressed state and a non-biased expanded state. For example, the retaining portion 770 can be configured to retain the first spike 722 in the expanded state, and the first slot 724 can be configured to receive the first spike 722 in a compressed state. Thus, the first spike 722 can be press-fit into the end portion 772 of the first slot 724, and an external force (e.g., by rotating the first component 730 relative to the second component 750) can push the first spike 722 (in a compressed state) through the first slot 724.

[0260] Although not shown, in some examples, the first locking mechanism 720 may also include a locking mechanism similar to that described above. Fig.14A The third nail and the third groove of 662 and 664. In some examples, the third groove can also be connected to another retaining portion configured to retain the third nail. For example, the third nail, the third groove and the retaining portion connected thereto can be configured to be similar to the nail 412 (or 512 / 722), the groove 414 (or 514 / 724) and the retaining portion 416 (or 516 / 770) described above, so as to further enhance the rotational locking / unlocking provided by the second locking mechanism 740.

[0261] Additional Examples of the Disclosed Technology

[0262] In view of the above implementation of the disclosed subject matter, the present application discloses the additional examples listed below. It should be noted that one feature of a separate example or one or more features of the examples adopted in combination, and optionally combined with one or more features of one or more other examples, are other examples that also fall within the disclosure of the present application.

[0263] Example 1. A handle assembly for a delivery device configured to deliver a prosthetic implant, the handle assembly comprising: a first component, the first component including a male connection portion, wherein the male connection portion includes a body having a pin extending radially outward from the body; a second component, the second component including a female connection portion, the female connection portion configured to receive the male connection portion of the first component, wherein the female connection portion includes an inner surface defining an inner hole, a groove extending along the inner surface, and a retaining portion connected to the groove and configured to receive the pin, wherein the first component and the second component can be moved between a locked configuration and a released configuration by inserting the body into the inner hole and rotating the male connection portion relative to the female connection portion about the axial axis of the body for less than one revolution, wherein in the locked configuration, the pin is located in the retaining portion and the groove is configured to prevent the male connection portion from rotationally moving relative to the female connection portion, and wherein in the released configuration, the pin is located in the groove.

[0264] Example 2. A handle assembly according to any example herein, in particular example 1, wherein the first component includes a spool configured to be connected to a release suture, the release suture extending through the inner hole of the second component and tied to the prosthetic implant.

[0265] Example 3. A handle assembly according to any example herein, in particular example 1, wherein the second component includes a spool configured to be connected to a release suture that extends through the lumen of the first component and is tied to the prosthetic implant.

[0266] Example 4. A handle assembly according to any example herein, in particular any one of Examples 1-3, wherein the groove includes an axial portion extending parallel to the axial axis and a circumferential portion connected to the axial portion and extending circumferentially around the axial axis, wherein the retaining portion is connected to the end of the circumferential portion.

[0267] Example 5. A handle assembly according to any example herein, in particular example 4, wherein the circumferential portion includes a deflectable portion adjacent to the retaining portion, such that the deflectable portion can be expanded when the pin is received in the deflectable portion.

[0268] Example 6. A handle assembly according to any example herein, in particular Example 5, wherein the female connecting portion includes at least one release channel, the at least one release channel extending parallel to the circumferential portion and configured to allow the deflectable portion to expand axially when the pin moves through the deflectable portion.

[0269] Example 7. A handle assembly according to any example herein, in particular any of Examples 5-6, wherein the female connecting portion includes a deformable material surrounding the deflectable portion, so that when the pin moves through the deflectable portion, the pin can compress the deformable material and cause the deflectable portion to expand axially.

[0270] Example 8. A handle assembly according to any example herein, in particular Example 4, wherein the pin is movable between a compressed state and an expanded state, the pin is biased toward the expanded state, wherein the retaining portion is configured to retain the pin in the expanded state, and the groove is configured to receive the pin in the compressed state.

[0271] Example 9. The handle assembly according to any example herein, in particular example 8, wherein the groove has a substantially constant diameter that matches the diameter of the pin in the compressed state.

[0272] Example 10. A handle assembly according to any example herein, in particular any of Examples 1-3, wherein the pin is a second pin and the slot is a second slot, wherein the male connection portion includes a first pin extending radially outward from the body, wherein the first pin is axially offset from the second pin by a predefined distance, and wherein the female connection portion includes a first slot configured to receive the first pin.

[0273] Example 11. A handle assembly according to any example herein, in particular Example 10, wherein the first groove includes an axial portion extending parallel to the axial axis and a circumferential portion extending circumferentially around the axial axis, wherein the axial portion has an axial length equal to the predefined distance.

[0274] Example 12. The handle assembly according to any example herein, in particular Example 11, wherein the male connection portion includes a third pin extending radially outward from the body, wherein the female connection portion includes a third slot configured to receive the third pin.

[0275] Example 13. The handle assembly according to any example herein, in particular example 12, wherein the first pin and the third pin are located at circumferentially opposite sides of the second pin.

[0276] Example 14. A handle assembly according to any example herein, in particular any of Examples 12-13, wherein the third groove includes an axial portion extending parallel to the axial axis and a circumferential portion extending circumferentially around the axial axis, wherein the circumferential portion of the third groove is axially aligned with the circumferential portion of the first groove.

[0277] Example 15. The handle assembly according to any example herein, in particular any of examples 12-14, wherein the first pin and the third pin have different sizes.

[0278] Example 16. The handle assembly according to any example herein, in particular any one of examples 12-15, wherein the first pin and the third pin have different shapes.

[0279] Example 17. The handle assembly according to any example herein, in particular any one of examples 1-16, wherein the retaining portion comprises a radially recessed stop relative to the groove and the inner surface of the female connecting portion.

[0280] Example 18. The handle assembly according to any example herein, in particular example 17, wherein the groove includes a radial protrusion adjacent to the radial recessed stop.

[0281] Example 19. The handle assembly according to any example herein, in particular Example 18, wherein the radial protrusion is configured to be radially pressable so that the radial protrusion can be radially compressed to allow the pin to move across the radial protrusion.

[0282] Example 20. The handle assembly according to any example herein, in particular any of Examples 18-19, wherein the pin is configured to be deformable such that the pin can be radially compressed when moved across the radial protrusion.

[0283] Example 21. A handle assembly for a delivery device configured to deliver a prosthetic implant, the handle assembly comprising: a first component, the first component comprising a female connection portion, wherein the female connection portion comprises an inner surface defining an inner hole and a pin extending radially inward from the inner surface; a second component, the second component comprising a male connection portion configured to be inserted into the inner hole of the female connection portion, wherein the male connection portion comprises an outer surface, a groove extending along the inner surface, and a retaining portion connected to the groove and configured to receive the pin, wherein the first component and the second component can be moved between a locking configuration and a release configuration by inserting the male connection portion into the inner hole and rotating the male connection portion relative to the female connection portion about an axial axis of the inner hole for less than one revolution, wherein in the locking configuration, the pin is located in the retaining portion and the groove is configured to prevent the male connection portion from rotationally moving relative to the female connection portion, and wherein in the release configuration, the pin is located in the groove.

[0284] Example 22. A handle assembly according to any example herein, in particular Example 21, wherein the second component includes a spool configured to be connected to a release suture, the release suture extending through the inner hole of the first component and tied to the prosthetic implant.

[0285] Example 23. A handle assembly according to any example herein, in particular Example 21, wherein the first component includes a spool configured to be connected to a release suture that extends through the lumen of the second component and is tied to the prosthetic implant.

[0286] Example 24. A handle assembly according to any example herein, in particular any of Examples 21-23, wherein the groove includes an axial portion extending parallel to the axial axis and a circumferential portion connected to the axial portion and extending circumferentially around the axial axis, wherein the retaining portion is connected to the end of the circumferential portion.

[0287] Example 25. A handle assembly according to any example herein, in particular Example 24, wherein the circumferential portion includes a deflectable portion adjacent to the retaining portion such that the deflectable portion can be expanded when the pin is received in the deflectable portion.

[0288] Example 26. A handle assembly according to any example herein, in particular Example 25, wherein the male connection portion includes at least one release channel, the at least one release channel extending parallel to the circumferential portion and configured to allow the deflectable portion to expand axially when the pin moves through the deflectable portion.

[0289] Example 27. A handle assembly according to any example herein, in particular any of Examples 25-26, wherein the male connection portion includes a deformable material surrounding the deflectable portion, so that when the pin moves through the deflectable portion, the pin can compress the deformable material and cause the deflectable portion to expand axially.

[0290] Example 28. A handle assembly according to any example herein, in particular Example 24, wherein the pin is movable between a compressed state and an expanded state, the pin is biased toward the expanded state, wherein the retaining portion is configured to retain the pin in the expanded state, and the groove is configured to receive the pin in the compressed state.

[0291] Example 29. The handle assembly according to any example herein, in particular example 28, wherein the groove has a substantially constant diameter that matches the diameter of the pin in the compressed state.

[0292] Example 30. A handle assembly according to any example herein, in particular any of Examples 21-23, wherein the pin is a second pin and the groove is a second groove, wherein the female connection portion includes a first pin extending radially inward from the inner surface, wherein the first pin is axially offset from the second pin by a predefined distance, and wherein the male connection portion includes a first groove configured to receive the first pin.

[0293] Example 31. A handle assembly according to any example herein, in particular Example 30, wherein the first groove includes an axial portion extending parallel to the axial axis and a circumferential portion extending circumferentially around the axial axis, wherein the axial portion has an axial length equal to the predefined distance.

[0294] Example 32. A handle assembly according to any example herein, in particular Example 31, wherein the female connection portion includes a third pin extending radially inward from the inner surface, and wherein the male connection portion includes a third slot configured to receive the third pin.

[0295] Example 33. A handle assembly according to any example herein, in particular example 32, wherein the first pin and the third pin are located at circumferentially opposite sides of the second pin.

[0296] Example 34. A handle assembly according to any example herein, in particular any of Examples 32-33, wherein the third groove includes an axial portion extending parallel to the axial axis and a circumferential portion extending circumferentially around the axial axis, wherein the circumferential portion of the third groove is axially aligned with the circumferential portion of the first groove.

[0297] Example 35. A handle assembly according to any example herein, in particular any of Examples 32-34, wherein the first pin and the third pin have different sizes.

[0298] Example 36. A handle assembly according to any example herein, in particular any of Examples 32-35, wherein the first pin and the third pin have different shapes.

[0299] Example 37. A handle assembly according to any example herein, in particular any of Examples 21-36, wherein the retaining portion comprises a radially recessed stop relative to the groove and the outer surface of the male connecting portion.

[0300] Example 38. The handle assembly according to any example herein, in particular Example 37, wherein the groove includes a radial protrusion adjacent to the radial recessed stop.

[0301] Example 39. The handle assembly according to any example herein, in particular Example 38, wherein the radial protrusion is configured to be radially pressable so that the radial protrusion can be radially compressed to allow the pin to move across the radial protrusion.

[0302] Example 40. A handle assembly according to any example herein, in particular any of Examples 38-39, wherein the pin is configured to be deformable so that the pin can be radially compressed when moving across the radial protrusion.

[0303] Example 41. A handle assembly for a delivery device configured to deliver a prosthetic implant, the handle assembly comprising: a suture lock configured to be connected to a release suture, the release suture being tied to the prosthetic implant; and an adapter comprising a lumen and an end portion, the lumen being configured for the release suture to extend therethrough, the end portion being configured to be releasably connected to a connecting portion of the suture lock via a locking and release mechanism, wherein the locking and release mechanism comprises a pin and a slot configured to receive the pin, wherein the slot comprises a deflectable portion and a retaining portion connected to the deflectable portion, wherein the retaining portion is configured to retain the pin, wherein the deflectable portion has a smaller diameter than the pin, wherein rotation of the suture lock relative to the adapter in a first direction is configured to cause the pin to move through the deflectable portion and lock into the retaining portion such that the deflectable portion inhibits the pin from moving out of the retaining portion, wherein rotation of the suture lock relative to the adapter in a second direction opposite to the first direction is configured to cause the pin to move out of the retaining portion through the deflectable portion.

[0304] Example 42. The handle assembly according to any example herein, in particular Example 41, wherein when connected, the connecting portion of the suture lock and the end portion of the adapter are coaxial about the axial axis.

[0305] Example 43. A handle assembly according to any example herein, in particular Example 42, wherein the groove includes a first groove portion extending parallel to the axial axis and a second groove portion connected to the first groove portion at a corner and extending circumferentially around the axial axis, wherein the second groove portion includes the deflectable portion and the retaining portion is located at the end of the second groove portion.

[0306] Example 44. A handle assembly according to any of the examples herein, in particular Example 43, wherein the second slot portion includes a cutout window extending radially through a wall of the end portion of the adapter or a wall of the connecting portion of the suture lock to expose the staple when the staple is moved to the cutout window.

[0307] Example 45. A handle assembly according to any example herein, in particular example 44, wherein the cutout window extends from the retaining portion to a cutout edge spaced apart from the corner.

[0308] Example 46. A handle assembly according to any of the examples herein, in particular any of Examples 44-45, wherein the locking and release mechanism also includes at least one release channel extending parallel to the second groove portion, wherein the release channel includes an opening extending radially through a wall of the end portion of the adapter or a wall of the connecting portion of the suture lock, so that when the nail moves through the deflectable portion, the deflectable portion can expand axially toward the release channel.

[0309] Example 47. A handle assembly according to any example herein, in particular Example 46, wherein the circumferential length of the release channel is the same as or greater than the circumferential length of the incision window.

[0310] Example 48. A handle assembly according to any example herein, in particular any of Examples 46-47, wherein the locking and releasing mechanism comprises two release channels parallel to and located on both sides of the second slot portion.

[0311] Example 49. A handle assembly according to any example herein, in particular any of Examples 43-48, wherein the diameter of the second slot portion gradually decreases from the corner to the deflectable portion.

[0312] Example 50. A handle assembly according to any example herein, in particular any of Examples 43-49, wherein the wall through which the groove is formed includes a deformable material surrounding the second groove portion, so that when the nail moves through the deflectable portion, the nail can compress the deformable material and cause the deflectable portion to expand axially.

[0313] Example 51. The handle assembly according to any example herein, in particular any one of Examples 41-50, wherein the staple is located on the connecting portion of the suture lock and the slot is located on the end portion of the adapter.

[0314] Example 52. A handle assembly according to any example herein, in particular Example 51, wherein the staples extend radially outward from a connecting portion of the suture lock, wherein the connecting portion of the suture lock is configured to be inserted into an inner hole of an end portion of the adapter.

[0315] Example 53. A handle assembly according to any example herein, in particular Example 51, wherein the staples extend radially inward from the connecting portion of the suture lock, wherein the end portion of the adapter is configured to be inserted into an inner hole of the connecting portion of the suture lock.

[0316] Example 54. The handle assembly according to any example herein, in particular any one of Examples 41-50, wherein the groove is located on the connecting portion of the suture lock and the staple is located on the end portion of the adapter.

[0317] Example 55. A handle assembly according to any example herein, in particular Example 54, wherein the staples extend radially outward from an end portion of the adapter, wherein the end portion of the adapter is configured to be inserted into an inner hole of a connecting portion of the suture lock.

[0318] Example 56. A handle assembly according to any example herein, in particular Example 54, wherein the staples extend radially inward from the end portion of the adapter, wherein the connecting portion of the suture lock is configured to be inserted into an inner hole of the end portion of the adapter.

[0319] Example 57. A handle assembly according to any example herein, in particular any one of Examples 41-56, wherein the locking and releasing mechanism is one of a plurality of locking and releasing mechanisms of the handle assembly.

[0320] Example 58. The handle assembly according to any example herein, in particular Example 57, comprises two locking and releasing mechanisms that are in diametrically opposed positions when the connecting portion of the suture lock is connected to the end portion of the adapter.

[0321] Example 59. A handle assembly according to any example herein, in particular any of Examples 57-58, wherein the pin of each locking and release mechanism is located on the connecting portion of the suture lock and the slot of each locking and release mechanism is located on the end portion of the adapter.

[0322] Example 60. A handle assembly according to any example herein, in particular any of Examples 57-58, wherein the slot of each locking and release mechanism is located on the connecting portion of the suture lock and the pin of each locking and release mechanism is located on the end portion of the adapter.

[0323] Example 61. A handle assembly for a delivery device configured to deliver a prosthetic implant, the handle assembly comprising: a suture lock configured to be connected to a release suture, the release suture being tied to the prosthetic implant; and an adapter comprising a lumen and an end portion, the lumen being configured for the release suture to extend therethrough, the end portion being configured to be releasably connected to a connecting portion of the suture lock via a locking and release mechanism, wherein the connecting portion of the suture lock and the end portion of the adapter are coaxial about an axial axis when connected, wherein the locking and release mechanism comprises a nail and a slot configured to receive the nail, wherein the nail is movable between a compressed state and an expanded state, the nail being biased toward the expanded state, wherein the slot comprises a track portion and a retaining portion connected to the track portion, wherein the retaining portion is configured to retain the staple in the expanded state, wherein the track portion is configured to receive the staple in the compressed state and has a smaller diameter than the staple in the expanded state, wherein rotation of the suture lock relative to the adapter in a first direction is configured to move the staple in the compressed state through the track portion and into the retaining portion such that the staple is locked therein in the expanded state, and the track portion inhibits movement of the staple from the retaining portion, wherein rotation of the suture lock relative to the adapter in a second direction opposite to the first direction is configured to move the staple from the expanded state to the compressed state and move the staple from the retaining portion through the track portion.

[0324] Example 62. A handle assembly according to any example herein, in particular Example 61, wherein the track portion includes a first track portion extending parallel to the axial axis and a second track portion connected to the first track portion at a corner and extending circumferentially around the axial axis, wherein the retaining portion is located at the end of the second track portion.

[0325] Example 63. A handle assembly according to any example herein, in particular any of Examples 61-62, wherein the track portion has a substantially constant diameter that matches the diameter of the nail in a compressed state.

[0326] Example 64. A handle assembly according to any example herein, in particular any of Examples 61-63, wherein the staple is located on the connecting portion of the suture lock and the slot is located on the end portion of the adapter.

[0327] Example 65. A handle assembly according to any example herein, in particular Example 64, wherein the staples extend radially outward from a connecting portion of the suture lock, wherein the connecting portion of the suture lock is configured to be inserted into an inner hole of an end portion of the adapter.

[0328] Example 66. A handle assembly according to any example herein, in particular Example 64, wherein the staples extend radially inward from the connecting portion of the suture lock, wherein the end portion of the adapter is configured to be inserted into an inner hole of the connecting portion of the suture lock.

[0329] Example 67. A handle assembly according to any example herein, in particular any of Examples 61-63, wherein the groove is located on the connecting portion of the suture lock and the staple is located on the end portion of the adapter.

[0330] Example 68. A handle assembly according to any example herein, in particular Example 67, wherein the staples extend radially outward from an end portion of the adapter, wherein the end portion of the adapter is configured to be inserted into an inner hole of a connecting portion of the suture lock.

[0331] Example 69. A handle assembly according to any example herein, in particular Example 67, wherein the staples extend radially inward from the end portion of the adapter, wherein the connecting portion of the suture lock is configured to be inserted into an inner hole of the end portion of the adapter.

[0332] Example 70. A handle assembly according to any example herein, in particular any of Examples 61-69, wherein the locking and releasing mechanism is one of a plurality of locking and releasing mechanisms of the handle assembly, and the plurality of locking and releasing mechanisms are circumferentially equidistant when the connecting portion of the suture lock is connected to the end portion of the adapter.

[0333] Example 71. A handle assembly for a delivery device configured to deliver a prosthetic implant, the handle assembly comprising: a suture lock configured to be connected to a release suture, the release suture being tied to the prosthetic implant; and an adapter comprising a lumen and an end portion, the lumen being configured for the release suture to extend therethrough, the end portion being configured to be releasably connected to a connecting portion of the suture lock via a locking and release mechanism, wherein the connecting portion of the suture lock and the end portion of the adapter are coaxial about an axial axis when connected, wherein the locking and release mechanism comprises a pin and a slot configured to receive the pin, wherein the slot comprises an axis extending parallel to the axial axis The adapter comprises an axial portion and a circumferential portion connected to the axial portion and extending circumferentially around the axial axis, wherein the locking and releasing mechanism further comprises a retaining portion connected to an end of the circumferential portion and configured to retain the staple, wherein the retaining portion has a larger diameter than the circumferential portion, wherein rotation of the suture lock relative to the adapter in a first direction is configured to cause the staple to move through the circumferential portion and lock into the retaining portion such that the circumferential portion inhibits the staple from being removed from the retaining portion, wherein rotation of the suture lock relative to the adapter in a second direction opposite to the first direction is configured to cause the staple to move from the retaining portion through the circumferential portion.

[0334] Example 72. A handle assembly according to any example herein, in particular Example 71, wherein the circumferential portion includes a deflectable portion adjacent to the retaining portion such that the deflectable portion can be expanded when the nail is received in the deflectable portion.

[0335] Example 73. A handle assembly according to any example herein, in particular Example 72, wherein the locking and release mechanism also includes one or more release channels, wherein the one or more release channels extend parallel to the circumferential portion and are configured to allow the deflectable portion to expand axially when the nail moves through the deflectable portion.

[0336] Example 74. A handle assembly according to any example herein, in particular any of Examples 72-73, wherein the wall through which the groove is formed includes a deformable material surrounding the deflectable portion, so that when the nail moves through the deflectable portion, the nail can compress the deformable material and cause the deflectable portion to expand axially.

[0337] Example 75. A handle assembly according to any example herein, in particular Example 71, wherein the nail is movable between a compressed state and an expanded state, the nail is biased toward the expanded state, wherein the retaining portion is configured to retain the nail in the expanded state, and the groove is configured to receive the nail in the compressed state.

[0338] Example 76. A handle assembly according to any example herein, in particular Example 75, wherein the slot has a substantially constant diameter that matches the diameter of the nail in a compressed state.

[0339] Example 77. A handle assembly according to any example herein, in particular any of Examples 71-76, wherein the staple is located on the connecting portion of the suture lock and the slot is located on the end portion of the adapter.

[0340] Example 78. A handle assembly according to any example herein, in particular any of Examples 71-76, wherein the groove is located on the connecting portion of the suture lock and the staple is located on the end portion of the adapter.

[0341] Example 79. A handle assembly according to any example herein, in particular any of Examples 71-78, wherein the connecting portion of the suture lock is configured to be inserted into the inner hole of the end portion of the adapter.

[0342] Example 80. A handle assembly according to any example herein, in particular any of Examples 71-78, wherein the end portion of the adapter is configured to be inserted into the inner hole of the connecting portion of the suture lock.

[0343] Example 81. A handle assembly for a delivery device configured to deliver a prosthetic implant, the handle assembly comprising: a suture lock, the suture lock being configured to be connected to a release suture, the release suture being tied to the prosthetic implant; and an adapter, the adapter comprising a lumen and an end portion, the lumen being configured for the release suture to extend therethrough, the end portion being configured to be releasably connected to a connecting portion of the suture lock via a locking and release mechanism, wherein the connecting portion of the suture lock and the end portion of the adapter are coaxial about an axial axis when connected, wherein the locking and release mechanism comprises a first locking mechanism and a second locking mechanism, wherein the first locking mechanism comprises a first nail and a first slot configured to receive the first nail, wherein when the first nail is received within a circumferential portion of the first slot, the suture The suture lock is configured to be rotatable but not axially movable relative to the adapter, wherein the second locking mechanism includes a second nail and a second slot configured to receive the second nail, the second slot extending circumferentially around the axial axis, wherein a radially recessed stop is connected to the second slot and configured to retain the second nail, wherein when the first nail is received within a circumferential portion of the first slot, rotation of the suture lock relative to the adapter in a first direction is configured to move the second nail through the second slot until the second nail snaps into the radially recessed stop so that the second slot inhibits the second nail from moving out of the radially recessed stop, wherein rotation of the suture lock relative to the adapter in a second direction opposite to the first direction is configured to move the second nail away from the radially recessed stop through the second slot.

[0344] Example 82. A handle assembly according to any example herein, in particular Example 81, wherein the first groove includes an axial portion extending parallel to the axial axis, wherein the circumferential portion is connected to the axial portion at a corner and extends circumferentially around the axial axis.

[0345] Example 83. A handle assembly according to any example herein, in particular Example 82, wherein the second groove is radially offset from the circumferential portion of the first groove by a distance approximately the same as the length of the axial portion of the first groove, so that when the first nail is received in the first groove at the corner, the second nail is received in the second groove.

[0346] Example 84. A handle assembly according to any example herein, in particular any example of Examples 81-83, wherein the first locking mechanism also includes a retaining portion, which is connected to the end of the circumferential portion and is configured to retain the first nail, wherein the end of the circumferential portion has a first cross-sectional area and the retaining portion has a second cross-sectional area that is larger than the first cross-sectional area.

[0347] Example 85. A handle assembly according to any example herein, in particular Example 84, wherein the first nail is configured to be retained in the retaining portion when the second nail is snap-fitted into the radial recessed stop.

[0348] Example 86. A handle assembly according to any example herein, in particular any of Examples 84-85, wherein the circumferential portion includes a deflectable portion adjacent to the retaining portion such that the deflectable portion can be expanded when the first nail is received in the deflectable portion.

[0349] Example 87. A handle assembly according to any example herein, in particular Example 86, wherein the first locking mechanism also includes one or more release channels, wherein the one or more release channels extend parallel to the circumferential portion and are configured to allow the deflection portion to expand axially when the first nail moves through the deflectable portion.

[0350] Example 88. A handle assembly according to any example herein, in particular any of Examples 86-87, wherein the wall through which the first groove is formed includes a deformable material surrounding the deflectable portion, so that when the first nail moves through the deflectable portion, the first nail can compress the deformable material and cause the deflectable portion to expand axially.

[0351] Example 89. A handle assembly according to any example herein, in particular any of Examples 84-85, wherein the first nail is movable between a compressed state and an expanded state, the first nail is biased toward the expanded state, wherein the retaining portion is configured to retain the first nail in the expanded state, and the first groove is configured to receive the first nail in a compressed state.

[0352] Example 90. A handle assembly according to any example herein, in particular any of Examples 81-89, wherein the first locking mechanism further comprises a third nail and a third groove configured to receive the third nail, wherein the third groove comprises a circumferential portion axially aligned with the circumferential portion of the first groove.

[0353] Example 91. A handle assembly according to any example herein, in particular Example 90, wherein the second slot is positioned between the first slot and the third slot when the connecting portion of the suture lock is connected to the end portion of the adapter.

[0354] Example 92. A handle assembly according to any example herein, in particular any of Examples 90-91, wherein the third groove includes an axial portion extending parallel to the axial axis and connected to a circumferential portion of the third groove.

[0355] Example 93. A handle assembly according to any example herein, in particular any of Examples 90-92, wherein the first nail and the third nail have different sizes.

[0356] Example 94. A handle assembly according to any example herein, in particular any of Examples 90-93, wherein the first nail and the third nail have different shapes.

[0357] Example 95. A handle assembly according to any example herein, in particular any of Examples 90-92, wherein the first nail and the third nail have substantially the same shape and size.

[0358] Example 96. A handle assembly according to any example herein, in particular any of Examples 81-95, wherein the second groove includes a radial protrusion adjacent to the radial recessed stop.

[0359] Example 97. The handle assembly of any example herein, in particular Example 96, wherein the radial protrusion is configured to be radially pressable such that the radial protrusion can be radially compressed to allow the second nail to move across the radial protrusion.

[0360] Example 98. A handle assembly according to any example herein, in particular Example 97, wherein the radial protrusion comprises a deformable material.

[0361] Example 99. A handle assembly according to any example herein, in particular any of Examples 97-98, wherein the second locking mechanism includes one or more release channels, wherein the one or more release channels are located beneath the radial protrusion and are configured to allow the radial protrusion to be radially compressed when the second nail moves across the radial protrusion.

[0362] Example 100. A handle assembly according to any example herein, in particular any of Examples 96-99, wherein the second nail is configured to be deformable so that the second nail can be radially compressed when moving across the radial protrusion.

[0363] Example 101. A handle assembly according to any example herein, in particular any of Examples 81-100, wherein the first staple and the second staple are located on a connecting portion of the suture lock, and the first slot and the second slot are located on an end portion of the adapter.

[0364] Example 102. A handle assembly according to any example herein, in particular any of Examples 81-100, wherein the first groove and the second groove are located on the connecting portion of the suture lock, and the first staple and the second staple are located on the end portion of the adapter.

[0365] Example 103. A handle assembly according to any example herein, in particular any of Examples 81-100, wherein the first staple and the second slot are located on a connecting portion of the suture lock, and the second staple and the first slot are located on an end portion of the adapter.

[0366] Example 104. A handle assembly according to any example herein, in particular any of Examples 81-100, wherein the first slot and the second staple are located on a connecting portion of the suture lock, and the first staple and the second slot are located on an end portion of the adapter.

[0367] Example 105. A handle assembly according to any example herein, in particular any of Examples 81-104, wherein the connecting portion of the suture lock is configured to be inserted into the inner hole of the end portion of the adapter.

[0368] Example 106. A handle assembly according to any example herein, in particular any of Examples 81-104, wherein the end portion of the adapter is configured to be inserted into the inner hole of the connecting portion of the suture lock.

[0369] Example 107. A handle assembly according to any example herein, in particular any of Examples 81-106, wherein the first locking mechanism and the second locking mechanism define a locking group, wherein the handle assembly includes a plurality of locking groups.

[0370] Example 108. A handle assembly according to any example herein, in particular Example 107, wherein the suture lock comprises two locking groups that are in diametrically opposed positions when the connecting portion of the suture lock is connected to the end portion of the adapter.

[0371] Example 109. A delivery device configured to deliver a prosthetic implant, the delivery device comprising: a handle assembly according to any example herein, in particular any one of Examples 41-108; and a delivery sheath extending distally from the handle assembly.

[0372] Example 110. A delivery device according to any example herein, in particular Example 109, wherein the adapter comprises a straight section and a branch extending laterally from the straight section, wherein an end portion of the adapter that is releasably connected to the connecting portion of the suture lock is located on the branch.

[0373] Example 111. A method of implanting a prosthetic implant, the method comprising: assembling a handle assembly according to any example herein, in particular any of Examples 41-108, wherein the assembly comprises rotating the suture lock relative to the adapter in the first direction so as to connect the suture lock to the adapter.

[0374] Example 112. The method according to any example herein, in particular Example 111, further comprising rotating the suture lock relative to the adapter in the second direction so as to disconnect the suture lock from the adapter.

[0375] Example 113. The method according to any example herein, in particular any one of Examples 111-112, further comprising cutting the release suture.

[0376] In view of the many possible examples to which the principles of the disclosed technology can be applied, it should be recognized that the examples shown are merely preferred examples of the technology and should not be taken as limiting the scope of the disclosure. Rather, the scope of the claimed subject matter is defined by the following claims and their equivalents.

[0377] 20. A method of implanting a prosthetic implant, the method comprising:

[0378] Assemble the handle assembly,

[0379] Wherein the assembling includes rotating the suture lock relative to the adapter in the first direction to connect the suture lock to the adapter.

Claims

1. A handle assembly for a delivery device configured to deliver a prosthetic implant, characterized in that The handle assembly includes: a suture lock configured to be connected to a release suture that is tied to the prosthetic implant; and an adapter including a lumen and an end portion, the lumen being configured for the release suture to extend therethrough, the end portion being configured to be releasably connected to the connecting portion of the suture lock via a locking and release mechanism, wherein the locking and release mechanism includes a staple and a slot configured to receive the staple, wherein the slot includes a deflectable portion and a retaining portion connected to the deflectable portion, wherein the retaining portion is configured to retain the staple, wherein the deflectable portion has a smaller diameter than the staple, wherein rotation of the suture lock relative to the adapter in a first direction is configured to cause the staple to move through the deflectable portion and lock into the retaining portion such that the deflectable portion inhibits the staple from being removed from the retaining portion, wherein rotation of the suture lock relative to the adapter in a second direction opposite to the first direction is configured to cause the staple to move from the retaining portion through the deflectable portion.

2. The handle assembly of claim 1, wherein when connected, the connecting portion of the suture lock and the end portion of the adapter are coaxial about an axial axis.

3. A handle assembly according to claim 2, wherein the groove includes a first groove portion extending parallel to the axial axis and a second groove portion connected to the first groove portion at a corner and extending circumferentially around the axial axis, wherein the second groove portion includes the deflectable portion and the retaining portion is located at the end of the second groove portion.

4. The handle assembly of claim 3, wherein the second slot portion includes a cutout window extending radially through a wall of the end portion of the adapter or a wall of the connecting portion of the suture lock to expose the staple when the staple is moved to the cutout window.

5. The handle assembly of claim 4, wherein the cutout window extends from the retaining portion to a cutout edge spaced apart from the corner.

6. A handle assembly according to any one of claims 4-5, wherein the locking and release mechanism also includes at least one release channel extending parallel to the second groove portion, wherein the release channel includes an opening extending radially through a wall of the end portion of the adapter or a wall of the connecting portion of the suture lock, so that when the nail moves through the deflectable portion, the deflectable portion can expand axially toward the release channel.

7. The handle assembly of claim 6, wherein a circumferential length of the release channel is the same as or greater than a circumferential length of the cutout window.

8. The handle assembly of claim 6, wherein the locking and releasing mechanism comprises two release channels parallel to and located on both sides of the second slot portion.

9. The handle assembly of any one of claims 3-5 and 7-8, wherein the diameter of the second slot portion gradually decreases from the corner to the deflectable portion.

10. A handle assembly according to any one of claims 3-5 and 7-8, wherein the wall through which the groove is formed includes a deformable material surrounding the second groove portion, so that when the nail moves through the deflectable portion, the nail can compress the deformable material and cause the deflectable portion to expand axially.

11. The handle assembly of any one of claims 1-5 and 7-8, wherein the staple is located on a connecting portion of the suture lock and the slot is located on an end portion of the adapter.

12. The handle assembly of claim 11, wherein the staples extend radially outward from a connecting portion of the suture lock, wherein the connecting portion of the suture lock is configured to be inserted into an inner bore of an end portion of the adapter.

13. The handle assembly of claim 11, wherein the spike extends radially inward from a connecting portion of the suture lock, wherein an end portion of the adapter is configured to be inserted into an inner bore of the connecting portion of the suture lock.

14. The handle assembly of any one of claims 1-5 and 7-8, wherein the slot is located on a connecting portion of the suture lock and the staple is located on an end portion of the adapter.

15. The handle assembly of claim 14, wherein the spike extends radially outward from an end portion of the adapter, wherein the end portion of the adapter is configured to be inserted into an inner bore of a connecting portion of the suture lock.

16. The handle assembly of claim 14, wherein the spike extends radially inward from the end portion of the adapter, wherein the connecting portion of the suture lock is configured to be inserted into the inner bore of the end portion of the adapter.

17. The handle assembly of any one of claims 1-5, 7-8, 12-13, and 15-16, wherein the locking and releasing mechanism is one of a plurality of locking and releasing mechanisms of the handle assembly.

18. The handle assembly of claim 17, wherein Two locking and releasing mechanisms are included that are in diametrically opposed positions when the connecting portion of the suture lock is connected to the end portion of the adapter.

19. The handle assembly of claim 17, wherein the spike of each locking and release mechanism is located on the connecting portion of the suture lock, and the slot of each locking and release mechanism is located on the end portion of the adapter.

20. The handle assembly of claim 17, wherein the slot of each locking and release mechanism is located on the connecting portion of the suture lock, and the spike of each locking and release mechanism is located on the end portion of the adapter.

21. A handle assembly for a delivery device configured to deliver a prosthetic implant, characterized in that The handle assembly comprises: a suture lock configured to be connected to a release suture, the release suture being tied to the prosthetic implant; and an adapter comprising a lumen and an end portion, the lumen being configured for the release suture to extend therethrough, the end portion being configured to be releasably connected to a connecting portion of the suture lock via a locking and release mechanism, wherein the connecting portion of the suture lock and the end portion of the adapter are coaxial about an axial axis when connected, wherein the locking and release mechanism comprises a staple and a slot configured to receive the staple, wherein the staple is movable between a compressed state and an expanded state, the staple being biased toward the expanded state, wherein the slot comprises a track portion and a retaining portion connected to the track portion, wherein the retaining portion is configured to retain the staple in the expanded state, wherein the track portion is configured to receive the staple in the compressed state and has a smaller diameter than the staple in the expanded state, wherein rotation of the suture lock relative to the adapter in a first direction is configured to move the staple in the compressed state through the track portion and into the retaining portion such that the staple is locked therein in the expanded state, and the track portion inhibits movement of the staple from the retaining portion, wherein rotation of the suture lock relative to the adapter in a second direction opposite to the first direction is configured to move the staple from the expanded state to the compressed state and move the staple from the retaining portion through the track portion.

22. The handle assembly of claim 21, wherein the track portion comprises a first track portion extending parallel to the axial axis and a second track portion connected to the first track portion at a corner and extending circumferentially around the axial axis, wherein the retaining portion is located at an end of the second track portion.

23. The handle assembly of any one of claims 21-22, wherein the track portion has a constant diameter that matches the diameter of the nail in a compressed state.

24. The handle assembly of any one of claims 21-22, wherein the staple is located on a connecting portion of the suture lock and the slot is located on an end portion of the adapter.

25. The handle assembly of claim 24, wherein the staples extend radially outward from a connecting portion of the suture lock, wherein the connecting portion of the suture lock is configured to be inserted into an inner bore of an end portion of the adapter.

26. The handle assembly of claim 24, wherein the staples extend radially inward from a connecting portion of the suture lock, wherein an end portion of the adapter is configured to be inserted into an inner bore of the connecting portion of the suture lock.

27. The handle assembly of any one of claims 21-22, wherein the slot is located on a connecting portion of the suture lock and the staple is located on an end portion of the adapter.

28. The handle assembly of claim 27, wherein the spike extends radially outward from an end portion of the adapter, wherein the end portion of the adapter is configured to be inserted into an inner bore of a connecting portion of the suture lock.

29. The handle assembly of claim 27, wherein the spike extends radially inward from an end portion of the adapter, wherein the connecting portion of the suture lock is configured to be inserted into an inner bore of the end portion of the adapter.

30. The handle assembly of any one of claims 21-22, wherein the locking and releasing mechanism is one of a plurality of locking and releasing mechanisms of the handle assembly, and the plurality of locking and releasing mechanisms are circumferentially equidistant when the connecting portion of the suture lock is connected to the end portion of the adapter.

31. A handle assembly for a delivery device configured to deliver a prosthetic implant, characterized in that The handle assembly comprises: a suture lock configured to be connected to a release suture, the release suture being tied to the prosthetic implant; and an adapter comprising a lumen and an end portion, the lumen being configured for the release suture to extend therethrough, the end portion being configured to be releasably connected to a connecting portion of the suture lock via a locking and release mechanism, wherein the connecting portion of the suture lock and the end portion of the adapter are coaxial about an axial axis when connected, wherein the locking and release mechanism comprises a staple and a slot configured to receive the staple, wherein the slot comprises an axial portion extending parallel to the axial axis and connected to the axial portion and a circumferential portion extending circumferentially around the axial axis, wherein the locking and release mechanism further comprises a retaining portion connected to a distal end of the circumferential portion and configured to retain the staple, wherein the retaining portion has a larger diameter than the circumferential portion, wherein rotation of the suture lock relative to the adapter in a first direction is configured to cause the staple to move through the circumferential portion and lock into the retaining portion such that the circumferential portion inhibits the staple from being removed from the retaining portion, wherein rotation of the suture lock relative to the adapter in a second direction opposite to the first direction is configured to cause the staple to move from the retaining portion through the circumferential portion.

32. The handle assembly of claim 31, wherein the circumferential portion includes a deflectable portion adjacent the retaining portion such that the deflectable portion can be expanded when the staple is received in the deflectable portion.

33. The handle assembly of claim 32, wherein the locking and release mechanism further comprises one or more release channels extending parallel to the circumferential portion and configured to allow the deflectable portion to expand axially as the nail moves through the deflectable portion.

34. A handle assembly according to any one of claims 32-33, wherein the wall through which the groove is formed includes a deformable material surrounding the deflectable portion, so that when the nail moves through the deflectable portion, the nail can compress the deformable material and cause the deflectable portion to expand axially.

35. The handle assembly of claim 31, wherein the nail is movable between a compressed state and an expanded state, the nail being biased toward the expanded state, wherein the retaining portion is configured to retain the nail in the expanded state, and the slot is configured to receive the nail in the compressed state.

36. The handle assembly of claim 35, wherein the slot has a constant diameter that matches the diameter of the nail in a compressed state.

37. The handle assembly of any one of claims 31-33 and 35-36, wherein the staple is located on a connecting portion of the suture lock and the slot is located on an end portion of the adapter.

38. The handle assembly of any one of claims 31-33 and 35-36, wherein the slot is located on the connecting portion of the suture lock and the staple is located on the end portion of the adapter.

39. The handle assembly of any one of claims 31-33 and 35-36, wherein the connecting portion of the suture lock is configured to be inserted into the inner hole of the end portion of the adapter.

40. The handle assembly of any one of claims 31-33 and 35-36, wherein the end portion of the adapter is configured to be inserted into the inner bore of the connecting portion of the suture lock.

41. A handle assembly for a delivery device configured to deliver a prosthetic implant, characterized in that The handle assembly includes: a suture lock configured to be connected to a release suture, the release suture being tied to the prosthetic implant; and an adapter including a lumen and an end portion, the lumen being configured for the release suture to extend therethrough, the end portion being configured to be releasably connected to a connecting portion of the suture lock via a locking and release mechanism, wherein the connecting portion of the suture lock and the end portion of the adapter are coaxial about an axial axis when connected, wherein the locking and release mechanism includes a first locking mechanism and a second locking mechanism, wherein the first locking mechanism includes a first nail and a first slot configured to receive the first nail, wherein when the first nail is received in a circumferential portion of the first slot, the suture lock is configured to be releasably connected relative to the adapter. The adapter is rotatable but not axially movable, wherein the second locking mechanism includes a second staple and a second slot configured to receive the second staple, the second slot extending circumferentially around the axial axis, wherein a radially recessed stop is connected to the second slot and configured to retain the second staple, wherein when the first staple is received within a circumferential portion of the first slot, rotation of the suture lock relative to the adapter in a first direction is configured to move the second staple through the second slot until the second staple snaps into the radially recessed stop such that the second slot inhibits the second staple from being removed from the radially recessed stop, wherein rotation of the suture lock relative to the adapter in a second direction opposite to the first direction is configured to move the second staple away from the radially recessed stop through the second slot.

42. The handle assembly of claim 41, wherein the first slot includes an axial portion extending parallel to the axial axis, wherein the circumferential portion is connected to the axial portion at a corner and extends circumferentially around the axial axis.

43. A handle assembly according to claim 42, wherein the second groove is radially offset from the circumferential portion of the first groove by a distance approximately the same as the length of the axial portion of the first groove, so that when the first nail is received in the first groove at the corner, the second nail is received in the second groove.

44. A handle assembly according to any one of claims 41-43, wherein the first locking mechanism further comprises a retaining portion, which is connected to the end of the circumferential portion and is configured to retain the first nail, wherein the end of the circumferential portion has a first cross-sectional area and the retaining portion has a second cross-sectional area that is larger than the first cross-sectional area.

45. The handle assembly of claim 44, wherein the first staple is configured to be retained in the retaining portion when the second staple is snap-fitted into the radially recessed stop.

46. ​​The handle assembly of claim 44, wherein the circumferential portion includes a deflectable portion adjacent the retaining portion such that the deflectable portion can be expanded when the first spike is received in the deflectable portion.

47. The handle assembly of claim 46, wherein the first locking mechanism further comprises one or more release channels extending parallel to the circumferential portion and configured to allow the deflection portion to expand axially when the first nail moves through the deflectable portion.

48. A handle assembly according to any one of claims 46-47, wherein the wall through which the first groove is formed includes a deformable material surrounding the deflectable portion, so that when the first nail moves through the deflectable portion, the first nail can compress the deformable material and cause the deflectable portion to expand axially.

49. The handle assembly of claim 44, wherein the first nail is movable between a compressed state and an expanded state, the first nail being biased toward the expanded state, wherein the retaining portion is configured to retain the first nail in the expanded state, and the first slot is configured to receive the first nail in the compressed state.

50. The handle assembly of any one of claims 41-43, 45-47, and 49, wherein the first locking mechanism further comprises a third spike and a third slot configured to receive the third spike, wherein the third slot comprises a circumferential portion axially aligned with a circumferential portion of the first slot.

51. The handle assembly of claim 50, wherein the second slot is positioned between the first slot and the third slot when the connecting portion of the suture lock is connected to the end portion of the adapter.

52. The handle assembly of claim 50, wherein the third slot includes an axial portion extending parallel to the axial axis and connected to a circumferential portion of the third slot.

53. The handle assembly of claim 50, wherein the first spike and the third spike have different sizes.

54. The handle assembly of claim 50, wherein the first spike and the third spike have different shapes.

55. The handle assembly of claim 50, wherein the first spike and the third spike have substantially the same shape and size.

56. The handle assembly of any one of claims 41-43, 45-47, 49, and 51-55, wherein the second slot includes a radial protrusion adjacent the radial recessed stop.

57. The handle assembly of claim 56, wherein the radial protrusion is configured to be radially depressible such that the radial protrusion can be radially compressed to allow the second staple to move across the radial protrusion.

58. The handle assembly of claim 57, wherein the radial protrusion comprises a deformable material.

59. A handle assembly according to any one of claims 57-58, wherein the second locking mechanism includes one or more release channels, which are located below the radial protrusion and are configured to allow the radial protrusion to be radially compressed when the second nail moves across the radial protrusion.

60. The handle assembly of claim 56, wherein the second spike is configured to be deformable such that the second spike can be radially compressed when moved across the radial protrusion.

61. The handle assembly of any one of claims 41-43, 45-47, 49, 51-55, 57-58 and 60, wherein the first staple and the second staple are located on a connecting portion of the suture lock, and the first slot and the second slot are located on an end portion of the adapter.

62. The handle assembly of any one of claims 41-43, 45-47, 49, 51-55, 57-58, and 60, wherein the first slot and the second slot are located on a connecting portion of the suture lock, and the first staple and the second staple are located on an end portion of the adapter.

63. The handle assembly of any one of claims 41-43, 45-47, 49, 51-55, 57-58 and 60, wherein the first spike and the second slot are located on the connecting portion of the suture lock, and the second spike and the first slot are located on the end portion of the adapter.

64. The handle assembly of any one of claims 41-43, 45-47, 49, 51-55, 57-58 and 60, wherein the first slot and the second spike are located on a connecting portion of the suture lock, and the first spike and the second slot are located on an end portion of the adapter.

65. The handle assembly of any one of claims 41-43, 45-47, 49, 51-55, 57-58, and 60, wherein the connecting portion of the suture lock is configured to be inserted into the inner hole of the end portion of the adapter.

66. The handle assembly of any one of claims 41-43, 45-47, 49, 51-55, 57-58, and 60, wherein the end portion of the adapter is configured to be inserted into the inner bore of the connecting portion of the suture lock.

67. The handle assembly of any one of claims 41-43, 45-47, 49, 51-55, 57-58, and 60, wherein the first locking mechanism and the second locking mechanism define a locking group, wherein the handle assembly includes a plurality of locking groups.

68. The handle assembly of claim 67, wherein the suture lock comprises two locking groups that are in diametrically opposed positions when the connecting portion of the suture lock is connected to the end portion of the adapter.

69. A delivery device configured to deliver a prosthetic implant, characterized in that The delivery device comprises: a handle assembly according to any one of claims 1-68; and a delivery sheath extending distally from the handle assembly.

70. The delivery device of claim 69, wherein the adapter comprises a straight section and a branch extending laterally from the straight section, wherein an end portion of the adapter that is releasably connected to the connecting portion of the suture lock is located on the branch.

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