Delivery device for prosthetic implant

Abstract

A delivery device for a prosthetic implant is disclosed herein. The suture lock assembly can include a suture tensioner configured to selectively rotate to collect a length of suture. The suture tensioner includes a pair of spaced apart posts and a connector connected to each of the posts. The suture lock assembly can also include a suture tensioner, a tensioner housing, and a quick release suture mechanism. The tensioner housing at least partially receives the suture tensioner and includes a suture entry port and a suture exit port. The suture tensioner is configured to selectively rotate relative to the tensioner housing to selectively increase the length of the suture enclosed by the tensioner housing. The quick release suture mechanism includes a quick release docking port and a suture anchor cap configured to be selectively coupled to and uncoupled from the quick release docking port.

Description

[0001] This application is a divisional application. The application date of the original application is June 20, 2023, the application number is 2023215711528, and the name of the invention is "Suture lock assembly with suture tensioner".

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS

[0003] This application claims the benefit of U.S. Provisional Application No. 63 / 366,731, filed on June 21, 2022, which is incorporated herein by reference in its entirety. Technical Field

[0004] The present disclosure is directed to a suture lock assembly having a suture tensioner, such as may be used in conjunction with a delivery device for delivering a prosthetic implant into a patient. Background Art

[0005] The human heart may suffer from various valvular diseases. These valvular diseases may cause significant dysfunction of the heart and ultimately require repairing the autologous valve or replacing the autologous valve with an artificial valve. There are many known repair devices (such as stents) and artificial valves, as well as many known methods for implanting these devices and valves into the human body. In various surgeries, percutaneous and minimally invasive surgical methods are used to deliver prosthetic medical devices to a position that is not easily accessible by surgery or a position that is expected to be accessible without surgery. In a specific example, a prosthetic heart valve can be mounted on the distal end of a delivery device in a curled state and advance through the patient's vascular system (for example, such as through the femoral artery and the aorta) until the prosthetic heart valve reaches the implantation site in the heart. Subsequently, for example, by inflating a balloon on which a prosthetic valve is mounted, a mechanical actuator that applies an expansion force to the prosthetic heart valve is actuated, or by deploying the prosthetic heart valve from the sheath of the delivery device so that the prosthetic heart valve can self-expand to its functional size, the prosthetic heart valve is expanded to its functional size. Utility Model Content

[0006] Delivery devices and methods for implanting a prosthetic heart valve are described herein. The disclosed delivery devices and methods can, for example, provide an improved releasable suture connection to a prosthetic heart valve and / or to a docking device for anchoring a prosthetic heart valve. Thus, the devices and methods disclosed herein can, among other things, overcome one or more deficiencies of typical prosthetic heart valve delivery devices.

[0007] A delivery device for a prosthetic implant may include a handle and one or more shafts coupled to the handle.

[0008] In some examples, the one or more shafts include a delivery shaft configured to be advanced through the patient's vasculature to the implantation site and configured to retain the implantable device.

[0009] In some examples, the implantable device includes a docking device.

[0010] In some examples, the delivery apparatus includes a pusher assembly configured to deploy and / or implant the implantable device at an implantation site.

[0011] In some examples, the implantable device is coupled to the delivery apparatus via sutures that can be cut to remove the implantable device from the delivery apparatus.

[0012] In some examples, the delivery device includes a suture lock assembly configured to engage the suture.

[0013] In some examples, the suture lock assembly includes a suture tensioner configured to engage the suture.

[0014] In some examples, the suture tensioner is configured to selectively increase or decrease the tension of the suture.

[0015] In some examples, the suture tensioner is configured to selectively rotate about a tensioner central axis to collect a length of the suture.

[0016] In some examples, the suture tensioner includes a pair of spaced-apart posts, each post being configured to rotate about the tensioner central axis as the suture tensioner rotates.

[0017] In some examples, the suture tensioner is configured to rotate so as to transition the suture tensioner between a plurality of tensioner configurations, the plurality of tensioner configurations being defined between and including a released configuration in which the post is positioned to apply no force to the suture and a fully tensioned configuration in which the post is positioned to engage the suture to produce maximum tension in the suture when the suture is connected to the implantable device.

[0018] In some examples, the suture lock assembly includes a tensioner housing that at least partially receives the suture tensioner.

[0019] In some examples, the suture lock assembly includes a quick-release suture mechanism that is configured to selectively transition between a locked configuration and an unlocked configuration, and the quick-release suture mechanism is configured such that the suture can be removed from the suture lock assembly when the quick-release suture mechanism is in the unlocked configuration.

[0020] In some examples, the quick-release suture mechanism includes a quick-release docking port and a suture anchoring cap configured to be selectively coupled to and decoupled from the quick-release docking port.

[0021] In one representative example, a suture lock assembly includes a suture tensioner configured to engage a suture configured to be connected to an implantable device. The suture tensioner is configured to selectively rotate about a tensioner central axis to collect a length of the suture. The suture tensioner includes a pair of spaced-apart posts and a connector connected to each of the posts. Each post is configured to rotate about the tensioner central axis as the suture tensioner rotates.

[0022] In another representative example, a suture lock assembly includes a suture tensioner, a tensioner housing, and a quick release suture mechanism. The suture tensioner is configured to engage a suture configured to be connected to an implantable device. The tensioner housing at least partially receives the suture tensioner and includes a suture entry port and a suture exit port, so that the suture extends through the tensioner housing between the suture entry port and the suture exit port. The quick release suture mechanism is coupled to the suture exit port. The suture tensioner is configured to selectively rotate about a tensioner central axis relative to the tensioner housing to selectively increase the length of the suture enclosed by the tensioner housing. The suture tensioner includes a pair of spaced-apart posts and a connector connected to each of the posts. Each post is configured to rotate about the tensioner central axis as the suture tensioner rotates relative to the tensioner housing. The quick release suture mechanism includes a quick release docking port and a suture anchor cap. The quick-release docking port is configured to be attached to the suture exit port, and the suture anchoring cap is configured to be selectively coupled to and detached from the quick-release docking port. The quick-release suture mechanism is configured to selectively switch between a locked configuration, in which the quick-release suture mechanism holds the suture in a fixed position relative to the suture exit port, and an unlocked configuration, in which the suture can be removed from the quick-release docking port. When the suture anchoring cap is operatively coupled to the quick-release docking port, the quick-release suture mechanism is in the locked configuration, and when the suture anchoring cap is removed from the quick-release docking port, the quick-release suture mechanism is in the unlocked configuration. The suture extends between a suture anchoring end and a suture free end and terminates at each of the suture anchoring end and the suture free end. The suture anchoring cap includes a suture anchoring location, and the suture anchoring cap is configured to be operatively coupled to the suture anchoring end at the suture anchoring location such that the suture anchoring end is restricted from being removed from the suture anchoring cap during operational use of the quick-release suture mechanism.

[0023] In some examples, a stitch lock assembly includes one or more of the components described in Examples 59 to 126 below.

[0024] The various innovations of the present disclosure may be used in combination or alone. The present disclosure is provided to introduce some concepts in a simplified form, which will be further described in the following detailed description. The present disclosure is not intended to identify the key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. The foregoing and other objects, features and advantages of the present disclosure will become more apparent from the following detailed description, claims and drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] Figure 1 A first stage in an exemplary mitral valve replacement procedure is schematically illustrated, wherein a guide catheter and guidewire are inserted into a patient's blood vessel and guided through the vessel and into the patient's heart toward the heart's native mitral valve.

[0026] Figure 2A A second stage in an exemplary mitral valve replacement procedure is schematically illustrated, in which a docking device delivery apparatus extending through a guide catheter implants a docking device for a prosthetic heart valve at the native mitral valve.

[0027] Figure 2B The third stage in an exemplary mitral valve replacement procedure is schematically shown, wherein Figure 2A The docking device is fully implanted in the patient's native mitral valve and the docking device delivery device is removed from the patient.

[0028] Figure 3A A fourth stage in an exemplary mitral valve replacement procedure is schematically illustrated, wherein a prosthetic heart valve delivery device extending through a guide catheter implants a prosthetic heart valve into an implanted docking device at the native mitral valve.

[0029] Figure 3B A fifth stage in an exemplary mitral valve replacement procedure is schematically illustrated, wherein the prosthetic heart valve is fully implanted within a docking device at the native mitral valve and the prosthetic heart valve delivery device has been removed from the patient.

[0030] Figure 4 A sixth stage in an exemplary mitral valve replacement procedure is schematically illustrated, wherein the guide catheter and guidewire have been removed from the patient.

[0031] Figure 5 is a perspective view of a docking device according to one example.

[0032] Fig. 6A is a side view of a delivery apparatus for a docking device according to one example.

[0033] Figure 6B Depicted Fig. 6A part of a delivery device.

[0034] Figure 6C yes FIG. 6A to FIG. 6B A perspective view of a suture lock assembly of a delivery device.

[0035] Fig.6D yes Figure 6C Side view of the stitch lock assembly.

[0036] Figure 7 A suture lock assembly including a spool and a quick release suture mechanism according to various examples is schematically illustrated.

[0037] Figure 8 is a cross-sectional side view of a quick-release suture mechanism in a locked configuration according to a first example.

[0038] Fig. 9 is a cross-sectional side view of a quick-release suture mechanism in an unlocked configuration according to a second example.

[0039] Fig. 10A A quick release suture mechanism is depicted in a locked configuration according to a third example.

[0040] Fig. 10B Depicted in unlocked configuration Fig. 10A Quick release suture mechanism.

[0041] Fig. 10C Depicted FIG. 10A to FIG. 10B A quick release suture mechanism wherein the release suture begins to be withdrawn from the quick release suture mechanism.

[0042] Fig. 10D Depicted FIG. 10A to FIG. 10B A quick release suture mechanism, wherein the release suture is completely withdrawn from the quick release suture mechanism.

[0043] Fig.11 A suture lock assembly including a suture tensioner and a quick release suture mechanism according to various examples is schematically illustrated.

[0044] Fig. 12A A suture tensioner is depicted in a released configuration according to one example.

[0045] Fig. 12B Depicted is the rotation of the suture tensioner. Fig. 12A The suture tensioner begins to engage and release the suture.

[0046] Fig. 12C As the suture tensioner is further rotated, FIG. 12A to FIG. 12B The suture tensioner engages to release the suture.

[0047] Fig.12D As the suture tensioner is further rotated, FIG. 12A to FIG. 12C The suture tensioner engages to release the suture.

[0048] Fig.12E Depicted FIG. 12A to FIG. 12D The suture tensioner engages the release suture in a fully tensioned configuration.

[0049] Fig.12F Depicted FIG. 12A to FIG. 12E A suture tensioner wherein the suture tensioner is rotated from a fully tensioned configuration toward a released configuration and wherein no distally directed force is applied to the released suture.

[0050] Figure 12G Depicted FIG. 12A to FIG. 12F A suture tensioner wherein the suture tensioner is further rotated toward a released configuration and wherein no distal guiding force is applied to the released suture.

[0051] Fig.13 A suture tensioner engaging a release suture according to another example is depicted.

[0052] Fig.14A is a cross-sectional side view of a suture lock assembly including a suture tensioner and a quick release suture mechanism according to a first example.

[0053] Fig. 14B yes Fig.14A Top view of the stitch lock assembly.

[0054] Fig.15A is a top view of a suture lock assembly including a suture tensioner and a quick release suture mechanism according to a second example.

[0055] Fig. 15B yes Fig.15A Front perspective view of the stitch lock assembly.

[0056] Fig. 15C yes FIG. 15A to FIG. 15B A rear perspective view of the stitch lock assembly.

[0057] Fig.15D yes FIG. 15A to FIG. 15C Cross-sectional view of a suture lock assembly.

[0058] Fig.15E It is along Fig.15A The line 15E-15E is observed FIG. 15A to FIG. 15D Another cross-sectional view of the stitch lock assembly.

[0059] Fig.15F It is along Fig. 15B The line 15F-15F is observed FIG. 15A to FIG. 15E Another cross-sectional view of the stitch lock assembly.

[0060] Figure 15G yes FIG. 15A to FIG. 15E Exploded view of the stitch lock assembly.

[0061] Fig.15H Depicted FIG. 15A to FIG. 15G Suture tensioner of the suture lock assembly.

[0062] Fig.15I It is along Figure 15G Line 15I-15I observed FIG. 15A to FIG. 15H Cross-sectional view of the suture anchoring cap of the suture lock assembly.

[0063] Fig.15J is operatively connected to FIG. 15A to FIG. 15I The suture lock assembly has a quick release suture mechanism and is operatively coupled to release the suture Fig.15I Cross-sectional view of the suture anchoring cap.

[0064] Figure 15K is operatively connected to FIG. 15A to FIG. 15J The suture lock assembly has a quick release suture mechanism and is operatively coupled to release the suture FIG. 15I to FIG. 15J Cross-sectional view of the suture anchoring cap.

[0065] Figure 15L is operatively connected to FIG. 15A to FIG. 15K The suture lock assembly has a quick release suture mechanism and is operatively coupled to release the suture FIG. 15I to FIG. 15K Cross-sectional view of the suture anchoring cap.

[0066] Figure 15M is operatively connected to FIG. 15A to FIG. 15L The suture lock assembly has a quick release suture mechanism and is operatively coupled to release the suture FIG. 15I to FIG. 15L Cross-sectional view of the suture anchoring cap. DETAILED DESCRIPTION

[0067] General considerations

[0068] It should be understood that the disclosed examples may be suitable for delivering and implanting prosthetic devices in any native valve annulus of the heart (e.g., the pulmonary valve annulus, mitral valve annulus, and tricuspid valve annulus) and may be used with any of a variety of delivery methods (e.g., retrograde, antegrade, transseptal, transventricular, transatrial, etc.).

[0069] For the purpose of this description, certain aspects, advantages and novel features of the examples of the present disclosure are described herein. The disclosed methods, devices and systems should not be interpreted as limiting in any way. On the contrary, the present disclosure relates to all novel and non-obvious features and aspects (alone and in various combinations and sub-combinations of each other) of the various disclosed examples. The methods, devices and systems are not limited to any specific aspect or feature or combination thereof, and the disclosed examples do not 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.

[0070] Although the operations of some disclosed examples are described in a specific, sequential order for ease of presentation, it should be understood that this description encompasses rearrangement unless the specific language set forth below requires a specific order. For example, in some cases, the operations described in sequence may be rearranged or performed simultaneously. 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 like "provide" or "implement" to describe the disclosed methods. These terms are high-level abstractions of the actual operations performed. The actual operations corresponding to these terms can vary depending on the specific implementation and are easily discernible by those of ordinary skill in the art.

[0071] 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 "comprising" means "including". 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 coupled or associated items in the absence of specific language to the contrary.

[0072] 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.

[0073] 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, including the end values.

[0074] As used herein, "such as" means "for example," and "ie" means "that is,."

[0075] Direction and other relative references (e.g., inside, outside, top, bottom, etc.) may be used to facilitate discussion of the drawings and principles of this document, but are not intended to be limiting. For example, certain terms such as "inside," "outside," "top," "downward," "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 "top" portion may become the "bottom" portion simply by flipping the object. Nevertheless, it is still the same portion and the object remains unchanged. As used herein, "and / or" means "and" or "or," as well as "and" and "or."

[0076] Delivery Technology

[0077] In order to implant the artificial valve in the native aortic valve via the transfemoral delivery method, the artificial valve is installed along the distal portion of the delivery device under radial compression. The distal portion of the artificial valve and the delivery device is inserted into the femoral artery and advanced into and through the descending aorta, around the aortic arch and through the ascending aorta. The artificial valve is positioned in the native aortic valve and radially expanded (e.g., by inflating the balloon, actuating one or more actuators of the delivery device or deploying the artificial valve from the sheath to allow the artificial valve to expand). Alternatively, the prosthetic valve can be implanted in the natural aortic valve in a transapical operation, whereby the prosthetic valve (on the distal end portion of the delivery device) is introduced into the left ventricle through the surgical opening in the chest and the apex, and the prosthetic valve is positioned in the natural aortic valve. Alternatively, in a transaortic procedure, a prosthetic valve (on the distal end portion of the delivery device) is introduced into the aorta through a surgical incision in the ascending aorta, such as through a partial J-shaped sternotomy or a right parasternal mini-thoracotomy, and is subsequently advanced through the ascending aorta toward the native aortic valve.

[0078] To implant a prosthetic valve into the native mitral valve via a transseptal delivery method, the prosthetic valve is mounted in a radially compressed state along the distal portion of the delivery device. The prosthetic valve and the distal portion of the delivery device are inserted into the femoral vein and advanced into and through the inferior vena cava, into the right atrium, through the atrial septum (through a perforation made in the atrial septum), into the left atrium, and advanced toward the native mitral valve. Alternatively, the prosthetic valve can be implanted into the native mitral valve in a transapical procedure, whereby the prosthetic valve (on the distal end portion of the delivery device) is introduced into the left ventricle through a surgical opening in the chest and the apex, and the prosthetic valve is positioned within the native mitral valve.

[0079] To implant the prosthetic valve into the native tricuspid valve, the prosthetic valve is installed along the distal portion of the delivery device in a radially compressed state. The prosthetic valve and the distal portion of the delivery device are inserted into the femoral vein and advanced into and through the inferior vena cava, and into the right atrium, and the prosthetic valve is positioned in the native tricuspid valve. A similar method can be used to implant the prosthetic valve into the native pulmonary valve or pulmonary artery, except that the prosthetic valve is advanced through the native tricuspid valve into the right ventricle and advanced toward the pulmonary valve / pulmonary artery.

[0080] Another delivery method is a transatrial approach, in which the prosthetic valve (on the distal end portion of the delivery device) is inserted through an incision in the chest and through an incision made through the atrial wall (of the right or left atrium) for access to any native heart valve. Atrial delivery can also be performed intravascularly, such as from the pulmonary veins. Yet another delivery method is a transventricular approach, in which the prosthetic valve (on the distal end portion of the delivery device) is inserted through an incision in the chest and through an incision made through the right ventricular wall (usually at or near the base of the heart) for implantation of the prosthetic valve into the native tricuspid valve, the native pulmonary valve, or the pulmonary artery.

[0081] In all delivery methods, the delivery device can be advanced over a guidewire previously inserted into the patient's vasculature. Moreover, the disclosed delivery methods are not intended to be limited. Any prosthetic valve disclosed herein can be implanted using any of a variety of delivery procedures and delivery devices known in the art.

[0082] Examples of Public Technology

[0083] Figures 1 to 4 An exemplary transcatheter heart valve replacement procedure (e.g., mitral valve replacement procedure) according to one example is depicted, which utilizes a docking device 52 and an artificial heart valve 62. During the procedure, the user first uses a guide catheter 30 ( Figure 1 ) creates a passage to the patient's native heart valve. The user then uses the docking device to deliver the device 50 ( Figure 2A) delivering and implanting the docking device 52 at the patient's native heart valve, and then removing the docking device delivery apparatus 50 from the patient 10 after implanting the docking device 52 ( Figure 2B The user then uses the artificial valve delivery device 60 ( Figure 3A ) implants the artificial heart valve 62 within the implanted docking device 52. Thereafter, the user removes the artificial valve delivery device 60 from the patient 10 ( Figure 3B ) and a guide catheter 30 ( Figure 4 ).

[0084] Figure 1 A first stage in a mitral valve replacement procedure according to one example is depicted, wherein a guide catheter 30 and guidewire 40 are inserted into a blood vessel 12 of a patient 10 and guided through the blood vessel 12, into the heart 14 of the patient 10, and toward the native mitral valve 16. The guide catheter 30 and guidewire 40 together can provide a path for a docking device delivery apparatus 50 and a prosthetic valve delivery apparatus 60 to be guided through and along the path to the implantation site (the native mitral valve 16 or the native mitral valve annulus).

[0085] Initially, the user may first make an incision in the patient's body to access the blood vessel 12. For example, Figure 1 In the example shown, the user can make an incision in the patient's groin to access the femoral vein. Therefore, in such examples, the blood vessel 12 can be the femoral vein.

[0086] After forming an incision at the blood vessel 12, the user can insert the guide catheter 30, the guide wire 40 and / or an additional device (such as an introducer device or a transseptal puncture device) into the blood vessel 12 through the incision. The guide catheter 30 (which may also be referred to as an "introducer device", "introducer" or "introducer sheath") is configured to facilitate the percutaneous introduction of various implant delivery devices (e.g., a docking device delivery device 50 and a prosthetic valve delivery device 60) into and through the blood vessel 12, and can extend through the blood vessel 12 and into the heart 14, but can stop before the native mitral valve 16. The guide catheter 30 may include a handle 32 and a shaft 34 extending distally from the handle 32. The shaft 34 can extend through the blood vessel 12 and into the heart 14, while the handle 32 remains outside the patient's 10 and can be operated by the user to manipulate the shaft 34 ( Figure 1 ).

[0087] The guidewire 40 is configured to guide a delivery device (e.g., a guide catheter 30, a docking device delivery device 50, a prosthetic valve delivery device 60, an additional catheter, etc.) and its associated devices (e.g., a docking device, a prosthetic heart valve, etc.) to an implantation site within the heart 14, and thus may extend through the blood vessel 12 and into the left atrium 18 of the heart 14 (and in some instances, through the native mitral valve 16 and into the left ventricle of the heart 14) ( Figure 1 ).

[0088] In some cases, a transseptal puncture device or catheter can be used to initially access the left atrium 18 prior to inserting the guidewire 40 and guide catheter 30. For example, after making an incision in the blood vessel 12, the user can insert the transseptal puncture device through the incision into the blood vessel 12. The user can guide the transseptal puncture device through the blood vessel 12 and into the heart 14 (e.g., through the femoral vein and into the right atrium 20). The user can then make a small incision in the atrial septum 22 of the heart 14 to allow access to the left atrium 18 from the right atrium 20. The user can then insert and advance the guidewire 40 through the transseptal puncture device in the blood vessel 12 and into the left atrium 18 through the incision in the atrial septum 22. Once the guidewire 40 is positioned within the left atrium 18 and / or left ventricle 26, the transseptal puncture device can be removed from the patient 10. The user can then insert the guide catheter 30 into the blood vessel 12 and ( Figure 1 ) Advance the guide catheter 30 into the left atrium 18.

[0089] In some cases, before the guide catheter 30 is inserted into the blood vessel 12, an introducer device can be inserted through the lumen of the guide catheter 30. In some cases, the introducer device can include a tapered end that extends out of the distal end of the guide catheter 30 and is configured to guide the guide catheter 30 into the left atrium 18 via the guide wire 40. In addition, in some cases, the introducer device can include a proximal portion that extends out of the proximal end of the guide catheter 30. Once the guide catheter 30 reaches the left atrium 18, the user can remove the introducer device from the guide catheter 30 and the patient 10. Therefore, only the guide catheter 30 and the guide wire 40 remain in the patient 10. The guide catheter 30 is then in place to receive the implant delivery device and help guide it to the left atrium 18, as described further below.

[0090] Figure 2A A second stage in an exemplary mitral valve replacement procedure is depicted in which a docking device 52 is implanted at the native mitral valve 16 of the heart 14 of the patient 10 using a docking device delivery apparatus 50 (which may also be referred to as an "implantation catheter" and / or a "docking device delivery apparatus").

[0091] Generally, the docking device delivery apparatus 50 includes a delivery shaft 54, a handle 56, and a pusher assembly 58. The delivery shaft 54 ​​is configured to be advanced by a user through the patient's vasculature (e.g., blood vessel 12) and to an implantation site (e.g., native mitral valve 16), and can be configured to retain the docking device 52 in the distal end portion 53 of the delivery shaft 54. In some examples, the distal end portion 53 of the delivery shaft 54 ​​retains the docking device 52 therein in a straightened delivery configuration.

[0092] The handle 56 of the docking device delivery apparatus 50 is configured to be grasped and / or otherwise held by a user outside the body of the patient 10 to advance the delivery shaft 54 ​​through the patient's vasculature (eg, blood vessel 12 ).

[0093] In some examples, the handle 56 may include one or more articulating members 57 (or rotatable knobs) configured to facilitate guiding the delivery shaft 54 ​​through the blood vessel 12. For example, the one or more articulating members 57 may include one or more of a knob, a button, a 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 portion 53 of the delivery shaft 54 ​​to facilitate guiding the delivery shaft 54 ​​through the blood vessel 12 and within the heart 14.

[0094] The pusher assembly 58 can be configured to deploy and / or implant the docking device 52 at an implantation site (e.g., the native mitral valve 16). For example, the pusher assembly 58 is configured to be adjusted by a user to push the docking device 52 out of the distal portion 53 of the delivery shaft 54. The shaft of the pusher assembly 58 can extend through the delivery shaft 54 ​​and can be disposed adjacent to the docking device 52 within the delivery shaft 54. In some examples, and as described in more detail below, the docking device 52 can be releasably coupled to the shaft of the pusher assembly 58 via a connection mechanism of the docking device delivery apparatus 50, so that the docking device 52 can be released after being deployed at the native mitral valve 16.

[0095] Further details of the docking device delivery apparatus and its variations are described in International Publication No. WO2020 / 247907, which is incorporated herein by reference in its entirety.

[0096] Reference again Figure 2A, after positioning the guide catheter 30 within the left atrium 18, the user can insert the docking device delivery device 50 (e.g., delivery shaft 54) into the patient 10 by advancing the delivery shaft 54 ​​of the docking device delivery device 50 through the guide catheter 30 and over the guidewire 40. In some examples, the guidewire 40 can be at least partially retracted away from the left atrium 18 and into the guide catheter 30. The user can then continue to advance the delivery shaft 54 ​​of the docking device delivery device 50 along the guidewire 40 through the blood vessel 12 until the delivery shaft 54 ​​reaches the left atrium 18, as shown in FIG. Figure 2A Specifically, the user can advance the delivery shaft 54 ​​of the docking device delivery device 50 toward the patient 10 by grasping the handle 56 of the docking device delivery device 50 and applying force thereon (e.g., pushing the handle). When advancing the delivery shaft 54 ​​through the blood vessel 12 and the heart 14, the user can adjust one or more hinged members 57 of the handle 56 to guide various turns, corners, constrictions, and / or other obstacles in the blood vessel 12 and the heart 14.

[0097] Once the delivery shaft 54 ​​reaches the left atrium 18 and extends out of the distal end of the guide catheter 30, the user can use the handle 56 (e.g., hinge member 57) to position the distal portion 53 of the delivery shaft 54 ​​at and / or near the posteromedial commissure of the native mitral valve 16. The user can then use the shaft of the pusher assembly 58 to push the docking device 52 out of the distal portion 53 of the delivery shaft 54 ​​to deploy and / or implant the docking device 52 within the annulus of the native mitral valve 16.

[0098] In some examples, the docking device 52 can be constructed from, formed from, and / or include a shape memory material and, therefore, can return to its initial, pre-formed shape when it leaves the delivery shaft 54 ​​and is no longer constrained by the delivery shaft 54. As one example, the docking device 52 can be initially formed as a coil and, therefore, can wrap around the leaflets 24 of the native mitral valve 16 when it leaves the delivery shaft 54 ​​and returns to its initial coiled configuration.

[0099] When the ventricular portion (e.g., Figure 2A After deploying the portion of the docking device 52 shown in the figure that is configured to be positioned within the left ventricle 26 and / or on the ventricular side of the native mitral valve 16), the user can then deploy the remaining portion of the docking device 52 (e.g., the atrial portion of the docking device 52) from the delivery shaft 54 ​​within the left atrium 18 by retracting the delivery shaft 54 ​​away from the posteromedial commissure of the native mitral valve 16.

[0100] After the docking device 52 is deployed and implanted at the native mitral valve 16, the user can disconnect the docking device delivery device 50 from the docking device 52. Once the docking device 52 is disconnected from the docking device delivery device 50, the user can retract the docking device delivery device 50 from the blood vessel 12 and away from the patient 10, so that the user can deliver and implant the artificial heart valve 62 within the implanted docking device 52 at the native mitral valve 16.

[0101] Figure 2B This third stage in the mitral valve replacement procedure is shown, in which the docking device 52 has been fully deployed and implanted at the native mitral valve 16, and the docking device delivery apparatus 50 (including the delivery shaft 54) has been removed from the patient 10, so that only the guidewire 40 and the guide catheter 30 remain within the patient 10. In some examples, after the docking device delivery apparatus is removed, the guidewire 40 can be advanced out of the guide catheter 30, through the implanted docking device 52 at the native mitral valve 16, and into the left ventricle 26 ( Figure 2A ). Thus, the guidewire 40 can help guide the prosthetic valve delivery device 60 through the annulus of the native mitral valve 16 and at least partially into the left ventricle 26.

[0102] like Figure 2B As shown, the docking device 52 can include a plurality of turns (or coils) that are wrapped around the leaflets 24 of the native mitral valve 16 (within the left ventricle 26). The implanted docking device 52 has a more cylindrical shape than the annulus of the native mitral valve 16, thereby providing a geometry that more closely matches the shape or contour of the artificial heart valve to be implanted. Therefore, the docking device 52 can provide a tighter fit between the artificial heart valve and the native mitral valve 16, and thus provide a better seal, as further described below.

[0103] Figure 3A The fourth stage in a mitral valve replacement procedure is depicted, in which a user uses a prosthetic valve delivery device 60 to deliver and / or implant an artificial heart valve 62 (which may also be referred to herein as a "transcatheter prosthetic heart valve" or "THV" for short), "replacement heart valve," and / or "prosthetic mitral valve") within a docking device 52.

[0104] like Figure 3A As shown, the prosthetic valve delivery device 60 may include a delivery shaft 64 and a handle 66, with the delivery shaft 64 extending distally from the handle 66. The delivery shaft 64 is configured to extend into the patient's vasculature to deliver, implant, expand the prosthetic heart valve and / or otherwise deploy the prosthetic heart valve 62 within the docking device 52 at the native mitral valve 16. The handle 66 is configured to be grasped and / or otherwise held by a user to advance the delivery shaft 64 through the patient's vasculature.

[0105] In some examples, the handle 66 may include one or more articulating members 68 configured to facilitate guiding the delivery shaft 64 through the blood vessel 12 and the heart 14. Specifically, the articulating member 68 may include one or more of a knob, button, wheel, and / or other type of physically adjustable control member configured to be adjusted by a user to flex, bend, twist, rotate, and / or otherwise articulate the distal portion of the delivery shaft 64 to facilitate guiding the delivery shaft 64 through the blood vessel 12 and into the left atrium 18 and left ventricle 26 of the heart 14.

[0106] In some instances, the prosthetic valve delivery device 60 can include an expansion mechanism 65 configured to radially expand and deploy the prosthetic heart valve 62 at the implantation site. Figure 3A As shown, the expansion mechanism 65 can include an inflatable balloon configured to be inflated to radially expand the prosthetic heart valve 62 within the docking device 52. The inflatable balloon can be coupled to the distal end portion of the delivery shaft 64.

[0107] In other examples, the prosthetic heart valve 62 can be self-expanding and can be configured to radially expand on its own upon removal of a sheath or capsule that radially compresses the prosthetic heart valve 62 over the distal end portion of the delivery shaft 64. In still other examples, the prosthetic heart valve 62 can be mechanically expandable, and the prosthetic valve delivery device 60 can include one or more mechanical actuators (e.g., expansion mechanisms) that are configured to radially expand the prosthetic heart valve 62.

[0108] like Figure 3A As shown, a prosthetic heart valve 62 is mounted in a radially compressed configuration about an expansion mechanism 65 (an inflatable balloon) on a distal end portion of a delivery shaft 64 .

[0109] In order to guide the distal end portion of the delivery shaft 64 to the implantation site, the user can insert the artificial valve delivery device 60 (delivery shaft 64) into the patient 10 through the guide catheter 30 and through the guide wire 40. The user can continue to advance the artificial valve delivery device 60 along the guide wire 40 (through the blood vessel 12) until the distal end portion of the delivery shaft 64 reaches the native mitral valve 16, as shown in FIG. Figure 3A More specifically, a user can advance the delivery shaft 64 of the prosthetic valve delivery device 60 by grasping the handle 66 and applying force thereon (e.g., pushing the handle). When advancing the delivery shaft 64 through the blood vessel 12 and the heart 14, the user can adjust one or more hinged members 68 of the handle 66 to guide various turns, corners, constrictions, and / or other obstacles in the blood vessel 12 and the heart 14.

[0110] The user can advance the delivery shaft 64 along the guidewire 40 until the radially compressed prosthetic heart valve 62 mounted around the distal portion of the delivery shaft 64 is positioned within the docking device 52 and the native mitral valve 16. In some examples, such as Figure 3A As shown, the distal end of the delivery shaft 64 and at least a portion of the radially compressed prosthetic heart valve 62 can be positioned within the left ventricle 26 .

[0111] Once the radially compressed prosthetic heart valve 62 is properly positioned within the docking device 52 ( Figure 3A ), the user can manipulate one or more actuators of the handle 66 of the artificial valve delivery device 60 to actuate the expansion mechanism 65 (for example, inflate the inflatable balloon), thereby radially expanding the artificial heart valve 62 within the docking device 52.

[0112] Figure 3B The fifth stage in the mitral valve replacement procedure is shown, wherein the artificial heart valve 62 is in its radially expanded configuration and implanted within the docking device 52 in the native mitral valve 16. Figure 3B As shown, the artificial heart valve 62 is received and retained in the docking device 52. Therefore, the docking device 52 helps to anchor the artificial heart valve 62 in the native mitral valve 16. The docking device 52 can achieve a better seal between the artificial heart valve 62 and the leaflets 24 of the native mitral valve 16 to reduce paravalvular leakage around the artificial heart valve 62.

[0113] Also like Figure 3B As shown, after the artificial heart valve 62 has been fully deployed and implanted within the docking device 52 at the native mitral valve 16, the artificial valve delivery device 60 (including the delivery shaft 64) is removed from the patient 10, so that only the guidewire 40 and the guide catheter 30 remain in the patient 10.

[0114] Figure 4 A sixth stage in the mitral valve replacement procedure is depicted, wherein the guidewire 40 and guide catheter 30 have been removed from the patient 10 .

[0115] although Figure 1-4 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 device 50, artificial valve delivery device 60, guide catheter 30, and / or guidewire 40), docking devices (e.g., docking device 52), replacement heart valves (e.g., artificial heart valve 62), and / or components thereof can be used to replace these other heart valves.

[0116] For example, when replacing a native tricuspid valve, the user may also enter the right atrium 20 via the femoral vein, but may not need to enter the left atrium 18 through the atrial septum 22. Instead, the user may leave the guidewire 40 in the right atrium 20 and perform the same and / or similar docking device implantation process at the tricuspid valve. Specifically, the user may push the docking device 52 out of the delivery shaft 54 ​​around the ventricular side of the tricuspid valve leaflet, release the remaining portion of the docking device 52 from the delivery shaft 54 ​​in the right atrium 20, and then remove the delivery shaft 54 ​​of the docking device delivery device 50 from the patient 10. The user may then advance the guidewire 40 through the tricuspid valve into the right ventricle, and perform the same and / or similar artificial heart valve implantation process at the tricuspid valve within the docking device 52. Specifically, the user may advance the delivery shaft 64 of the artificial valve delivery device 60 along the guidewire 40 through the patient's vascular system until the artificial heart valve 62 is positioned / set within the docking device 52 and the tricuspid valve. The user may then expand the prosthetic heart valve 62 within the docking device 52 before removing the prosthetic valve delivery apparatus 60 from the patient 10. 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.

[0117] In addition, despite Figure 1-4 A mitral valve replacement procedure is depicted in which the native mitral valve 16 is accessed from the left atrium 18 via the right atrium 20 and the femoral vein, but it should be appreciated that the native mitral valve 16 may alternatively be accessed from the left ventricle 26. For example, a user may advance one or more delivery devices through the arteries to the aortic valve, and from the left ventricle 26 to the native mitral valve 16 via the aortic valve.

[0118] Figure 5 A docking device 70 according to one example is shown. The docking device 70 can be used, for example, as a docking device 52 in a prosthetic valve implantation procedure, as described above with reference to Figures 1 to 4 As stated. Figure 5 As depicted, the docking device in its deployed configuration can be configured to receive and secure a prosthetic valve within the docking device, thereby securing the prosthetic valve at the native annulus.

[0119] The docking device 70 can include a coil 72 and a protective member 74 covering at least a portion of the coil 72. In some examples, the coil 72 can include a shape memory material (e.g., nickel titanium alloy or "nitinol") so that the docking device 70 (and the coil 72) can move from a substantially straight configuration (or delivery configuration) when disposed within the delivery shaft 54 ​​of the delivery device 50 to a helical deployment configuration after removal from the delivery shaft 54.

[0120] The coil 72 has a proximal end 72p and a distal end 72d (which also define the proximal and distal ends of the docking device 70, respectively). When disposed within the delivery shaft 54 ​​(e.g., during delivery of the docking device 70 into the patient's vasculature), the body of the coil 72 between the proximal end 72p and the distal end 72d can form a substantially straight delivery configuration (i.e., without any coiled or annular portions, but can be flexed or bent) so as to maintain a small radial profile when moving through the patient's vasculature. After being removed from the delivery shaft 54 ​​and deployed at the implantation site, the coil 72 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 72 can be configured to surround the native leaflet of the native valve (and the chordae tendineae connecting the native leaflets to the adjacent papillary muscles, if present).

[0121] The docking device 70 can be releasably coupled to the docking device delivery apparatus 50. For example, in some examples, the docking device 70 can be coupled to the delivery apparatus (as described above) via a release suture that can be configured to be tied to the docking device 70 and cut for removal.

[0122] like Figure 5 As shown, the coil 72 in the deployed configuration may include a guide turn 76 (or "guide coil") around a central longitudinal axis, a central region 78, and a stabilizing turn 80 (or "stabilizing coil"). The central region 78 may have one or more spiral turns with substantially equal inner diameters. In the example shown, the guide turn 76 may extend from the distal end of the central region 78 and have a diameter larger than the diameter of the central region 78. In the example shown, the stabilizing turn 80 may extend from the proximal end of the central region 78 and have a diameter larger than the diameter of the central region 78.

[0123] Further details of the docking device and its variations are described in International Application No. PCT / US2021 / 056150, which is incorporated herein by reference in its entirety.

[0124] Fig. 6A A delivery device 200 is shown according to one example, the delivery device being configured to attach a docking device (such as the docking device 70 (described below) Figure 5 ) or other docking device) is implanted into a target implantation site in a patient's body. For example, the delivery device 200 can be used as a docking device delivery device 50 in a prosthetic valve implantation procedure, as described above with reference to Figure 2A The delivery device 200 may also be referred to as a "docking device delivery device," "docking delivery catheter," or "docking delivery system."

[0125] As shown, the delivery device 200 may include a handle assembly 202 and a delivery shaft 204 (also referred to as a "delivery sheath" or "outer shaft" or "outer sheath") extending distally from the handle assembly 202. The handle assembly 202 may include a handle 206 that includes one or more knobs, buttons, wheels, and / or other devices for controlling and / or actuating one or more components of the delivery device 200. For example, in some examples, such as Fig. 6A As shown, the handle 206 can include knobs 208 and 210 that can be configured to manipulate or control the deflection of a delivery device 200, such as the delivery shaft 204 and / or cannula shaft 220 described below.

[0126] In some examples, the delivery device 200 can also include 224 212 and a cannula shaft 220 , both of which can extend through the inner lumen of the delivery shaft 204 and have respective proximal end portions extending into the handle assembly 202 .

[0127] As described below, the distal end portion (also referred to as the "distal section") of the cannula shaft 220 can be configured to cover (eg, surround) the docking device 70 (see Figure 5 ). For example, the docking device 70 can be retained within the cannula shaft 220, which is further retained by the distal end portion 205 of the delivery shaft 204 when guided through the patient's vasculature.

[0128] In addition, the distal end portion 205 of the delivery shaft 204 can be configured to be steerable. In one example, by rotating a knob (e.g., 208 or 210) on the handle 206, the curvature of the distal end portion 205 can be adjusted so that the distal end portion 205 of the delivery shaft 204 can be oriented at a desired angle. For example, in order to implant the docking device 70 at the native mitral valve location, the distal end portion 205 of the delivery shaft 204 can be steered within the left atrium so that the cannula shaft 220 and at least a portion of the docking device 70 retained therein can extend through the native mitral valve annulus at a location adjacent to the posteromedial commissure.

[0129] In some examples, the pusher shaft 212 and the cannula shaft 220 can be coaxial with each other at least within the delivery shaft 204. In addition, the delivery shaft 204 can be configured to be axially movable relative to the cannula shaft 220 and the pusher shaft 212. As further described below, the distal end of the pusher shaft 212 can be inserted into the lumen of the cannula shaft 220 and pressed against the proximal end of the docking device 70 held inside the cannula shaft 220.

[0130] After reaching the target implantation site, the docking device 70 can be deployed from the delivery shaft 204 by manipulating the pusher shaft 212 and the cannula shaft 220 using the hub assembly 218, as described further below. For example, by pushing the pusher shaft 212 in the distal direction while holding the delivery shaft 204 in place, or by retracting the delivery shaft 204 in the proximal direction while holding the pusher shaft 212 in place, or by pushing the pusher shaft 212 in the distal direction while retracting the delivery shaft 204 in the proximal direction, the docking device 70 can be pushed out of the distal end 204d of the delivery shaft 204, thereby allowing the docking device 70 to be converted from the delivery configuration to the deployed configuration (see Figure 5 ). In some examples, the pusher shaft 212 and the quill shaft 220 can be actuated independently of each other.

[0131] During delivery, the docking device 70 can be secured via a release suture extending through the pusher shaft 212 ( Fig. 6A 200) (or other retrieval line comprising a rope, yarn, or other material that can be configured to be tied around the docking device 70 and cut for removal) is coupled to the delivery device 200. In one specific example, the release suture can extend through the delivery device 200, for example, through the inner lumen of the pusher shaft 212, to the suture lock assembly 216 of the delivery device 200.

[0132] The handle assembly 202 may also include a hub assembly 218 to which the suture lock assembly 216 and the cannula handle 224 are attached. The hub assembly 218 may be configured to independently control the pusher shaft 212 and the cannula shaft 220, while the cannula handle 224 may control the axial position of the cannula shaft 220 relative to the pusher shaft 212. In this manner, the operation of the various components of the handle assembly 202 may actuate and control the operation of the components disposed within the delivery shaft 204. In some examples, the hub assembly 218 may be coupled to the handle 206 via a connector 226.

[0133] The handle assembly 202 may also include one or more irrigation ports (e.g., Fig. 6A An irrigation port 232 is shown in FIG. 2 to supply irrigation fluid to one or more lumens disposed within the delivery device 200 (eg, an annular lumen disposed between coaxial components of the delivery device 200 ).

[0134] FIG. 6B to FIG. 6D Shown in more detail Fig. 6AAspects of the handle assembly 202 and / or the stitch lock assembly 216 of the hub assembly 218. As shown, the hub assembly 218 may include a Y-shaped connector 240 (also referred to as an "adapter") having a straight section 242 (e.g., a straight catheter) and at least one branch 244 (e.g., a branch catheter), although in some examples, the Y-shaped connector may include more than one branch. In some examples, the stitch lock assembly 216 can be attached to the branch 244, and the cannula handle (e.g., a cannula actuation handle) 224 can be disposed at the proximal end of the straight section 242.

[0135] like FIG. 6A to FIG. 6D As shown and described above, the delivery device 200 can include a suture lock assembly 216 located on the branch 244 of the hub assembly 218 of the handle assembly 202. As described below, the exemplary suture lock assembly 216 includes a release knob 284 that can be screwed onto one end of the Y-shaped connector 240.

[0136] like Figure 6B As depicted in , the hub assembly 218 can include a flush port 234 configured to allow flushing of one or more lumens within the delivery device 200 to sterilize and / or maintain hemostasis within the delivery device 200 .

[0137] As discussed above, a medical professional can deploy a docking device (e.g., docking device 70) by manipulating the position of the handle assembly 202, and only add an additional step to retract the cannula by pulling back the cannula handle 224. The cannula shaft (e.g., cannula shaft 220) and the pusher shaft (e.g., pusher shaft 212) can be configured to work together so that when the docking device is deployed and positioned at the native valve, they can move together at the same time (e.g., by moving the entire hub assembly 218 and / or Y-shaped connector 240 forward and / or backward). In addition, the cannula shaft and the pusher shaft can also be configured to move independently so that the pusher shaft can keep the docking device in place when the cannula shaft is retracted from the docking device (e.g., by keeping the hub assembly 218 and / or connector 240 in place relative to the delivery shaft 204 and / or other parts of the delivery device 200 and / or the docking device while pulling the cannula handle 224 proximally to extract the cannula shaft). As described above, the cannula shaft and the pusher shaft can be coaxial along part, all, or a majority of the delivery device 200 to facilitate working together.

[0138] like FIG. 6A to FIG. 6D As shown, the suture lock assembly 216 may include a rotator 272 (which may also be referred to as a "rotatable handle") to increase and decrease the release of the suture 236 (eg, Figure 6B), the release suture may extend from the suture lock assembly 216, through the branch 244, and through the handle 222 and the delivery shaft 204 to connect to the docking device, as described above.

[0139] In some examples, the release suture 236 can be wound around the reel 278 of the suture lock assembly 216 (see, e.g., Figure 6C ). The rotator 272 can be coupled to the reel 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 200. Providing tension or slack to the release suture 236 via rotating the rotator 272 (and thus rotating the reel 278) can respectively move the docking device 70 closer to or further away from the delivery device 200. As used herein, the reel 278 may also be referred to as a mandrel 278.

[0140] In some examples, the rotator 272 may include one or more gripping portions or gripping parts, which increase the convenience of gripping the rotator 272 (e.g., via the user's hand) without slipping. For example, and as shown in Figure 3, the rotator 272 may include a gripping portion 273, which is arranged around the circumference of the rotator 272 and is configured to be gripped by the user during the rotation of the rotator 272. In some examples, the gripping portion 273 may include a plurality of ridges to increase the convenience of traction and gripping. In some examples, the gripping portion 273 may include a material having a lower hardness (e.g., a reduced hardness) than the material forming another part of the rotator 272.

[0141] In some examples, such as Figure 6B As shown, the rotator 272 may include an indicator 275 to track the number of turns (or portions thereof) applied, which in turn may be correlated to the amount of slack or tension in the released suture 236 .

[0142] In some examples, the stitch lock assembly 216 may also include a direction control mechanism, which may include a direction selector 274 (e.g., in the form of a switch, such as FIG. 6B to FIG. 6C 274 ), the direction selector allows medical personnel or other users to select whether to increase or decrease the slack of the release suture 236 passing through the delivery device 200. For example, the direction selector 274 can be configured to allow medical personnel or other users 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 an incorrect direction.

[0143] In some examples, such as Figure 6CAs shown, the housing 262 of the stitch lock assembly 216 may include a first icon 264 indicating a relaxed position of the direction selector 274 and a second icon 266 indicating a tensioned position of the direction selector 274 .

[0144] Additional details of a directional control mechanism for a suture lock assembly, such as suture lock assembly 216, are described in international patent application PCT / US2020 / 36577, the disclosure of which is incorporated herein by reference.

[0145] In some examples, the stitch lock assembly 216 can include a connector or connecting portion to attach the stitch lock assembly 216 to a handle assembly (e.g., the handle assembly 202). For example, the stitch lock assembly 216 can include a release rod 282 that extends into and is coupled to the housing 262 of the stitch lock assembly 216 (e.g., see Figure 6C In some examples, release lever 282 can be bonded to housing 262 (eg, via adhesive, welding, or other non-removable securing means). Figure 6C As shown, the release knob 284 can be disposed around a portion of the release rod 282 adjacent to the connection portion 286 of the bottom housing 268. The release knob 284 can be configured to connect the stitch lock assembly 216 to the adapter 240 of the delivery device.

[0146] As mentioned above and as Figure 6B As depicted in FIG. 2 , the adapter 240 may include a branch 244 and a straight section 242. In the depicted example, a release knob 284 may be screwed onto one end of the adapter 240 (e.g., the proximal end of the branch 244) to secure the stitch lock assembly 216 to the adapter 240. In some examples, the shape, size, and / or configuration of the adapter 240 may be similar to that of the adapter 240. Figure 6B , and may vary based on the delivery device to which (and with which) the suture lock assembly 216 is configured to be attached.

[0147] In some examples, when the release knob 284 is coupled to each of the adapter 240 (or another adapter of the delivery device) and the release lever 282, the suture lock assembly 216 can be coupled to the delivery device and the suture cutting section 254 can be covered by the adapter 240 (e.g., see Figure 6C). 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 from the adapter 240 to release the stitch lock assembly 216 from the adapter 240, and the stitch lock assembly 216 can be pulled proximally away from the adapter 240 to expose the stitch cutting section 254. In alternative examples, rotating the release knob 284 (e.g., moving the release knob 284 toward the housing 262) can expose the stitch cutting section 254 without pulling the entire stitch lock assembly 216 away from the adapter 240.

[0148] The suture cutting section 254 may be configured to allow a user or medical practitioner to cut the release suture 236 through the length of the delivery device to allow the docking device to be disconnected from the delivery device when it is deployed at the target implantation site.

[0149] In some examples, once the release suture 236 is wrapped around the docking device or implant and guided through the delivery device, through the release rod 282 (including through the suture cutting section 254) and into the housing 262, the two suture ends of the release suture 236 can be passed through two holes arranged at the bottom end of the reel 278 and then tied to complete the suture loop.

[0150] like Fig. 6A and Fig.6D As depicted in , the suture lock assembly 216 may include a flush port 215 to allow flushing of one or more lumens within the delivery device to reduce thrombosis between components of the delivery device, maintain hemostasis within the delivery device, and / or sterilize the delivery device. In some cases, the flush port 215 can be configured to allow independent flushing of the lumens if a single flush line becomes clogged and / or fails to maintain hemostasis 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 as desired by the practitioner without requiring a constant flow rate. As discussed above, Fig.6D The flush port 215 depicted in FIG. 1 allows for flushing similar to multiple flush ports (such as Fig. 6A The flushing port 232 and / or Figure 6B The flushing port 234 shown in the figure is connected to an additional flushing line. For simplicity, the flushing port 215 is not shown in the figure. FIG. 6B to FIG. 6C However, it should be understood that FIG. 6B to FIG. 6C The illustrated stitch lock assembly 216 may also include a flush port 215 .

[0151] Further details regarding delivery devices / catheters / systems configured to deliver a docking device to a target implantation site (including various examples of handle assemblies) can be found in International Application No. PCT / US2020 / 036577 and U.S. Patent Publication Nos. 2018 / 0318079 and 2018 / 0263764, each of which is incorporated herein by reference in its entirety.

[0152] As discussed above, once the docking device 70 is implanted at the target implantation site, the release suture 236 is released from the docking device 70. FIG. 6A to FIG. 6D In the example of the embodiment of the present invention, this is achieved by removing the stitch lock assembly 216 from the hub assembly 218 to expose the stitch cutting section 254, within which the release stitch 236 can be cut. In other examples, and as discussed below, the stitch lock assembly can be configured to remain coupled to the hub assembly 218 and / or delivery device 200 when the release stitch is removed from the docking device. As described in more detail below, such a device can facilitate the removal of the release stitch 236 from the docking device 70.

[0153] Figure 7 Schematically illustrated is an example of a stitch lock assembly 300 that includes a quick release suture mechanism 302 configured to facilitate the release of a suture 236 from an implantable device, such as a docking device 70. The stitch lock assembly 300 may include any of the features, characteristics, properties, etc. disclosed herein with reference to the stitch lock assembly 216, and vice versa. In particular, Figure 7 An example is shown in which the stitch lock assembly 300 includes a reel 340 (which can be similar or identical to the reel 278) for collecting a length of release suture 236 and / or adjusting the tension of the release suture. The stitch lock assembly 300 further includes a tensioner housing 350 that at least partially receives the reel 340.

[0154] Figure 8 to Figure 1 0. FIG. 14A to FIG. 15G and FIG. 15I to FIG. 15M Several additional examples of quick release suture mechanisms 302 are shown, as described in more detail below. In particular, Figure 8 A first exemplary quick release suture mechanism 302a is shown, while Fig. 9 A second exemplary quick release suture mechanism 302b is shown, and FIG. 10A to FIG. 10D A third exemplary quick release suture mechanism 302c is shown. FIG. 14A to FIG. 14B A fourth exemplary quick release suture mechanism 302d is shown, and FIG. 15A to FIG. 15G and FIG. 15I to FIG. 15M A fifth exemplary quick release suture mechanism 302e is shown. Figure 7The disclosed features, characteristics, properties, etc. of the quick release suture mechanism 302 may also be understood to be applicable to any quick release suture mechanism 302a / 302b / 302c / 302d / 302e, and vice versa.

[0155] Although the present disclosure as a whole relates to examples of the use of suture lock assemblies 300 and / or quick release suture mechanisms 302 in combination with release sutures 236, this is not required, and in addition, suture lock assemblies 300 and / or quick release suture mechanisms 302 can be used in combination with any suitable sutures within the scope of the present disclosure. For example, suture lock assemblies 300 and / or quick release suture mechanisms 302 can be used in combination with sutures that are not configured to be coupled to and / or release an implantable device. Therefore, as used herein, release suture 236 may additionally or alternatively be referred to as suture 236.

[0156] Furthermore, while the present disclosure as a whole relates to examples where the quick release suture mechanism 302 is used in conjunction with the suture lock assembly 300, this is not required. For example, it is also within the scope of the present disclosure that the quick release suture mechanism 302 can be used independently of the suture lock assembly or the associated suture tensioning mechanism. In particular, in some examples, the docking device delivery apparatus 50 and / or the prosthetic valve delivery apparatus 60 does not include a mechanism for adjusting the slack of the release suture 236, but can still be used in conjunction with the quick release suture mechanism 302 to release the release suture 236.

[0157] In the present disclosure, reference numerals that include letter labels (e.g., "a," "b," "c," etc.) should be understood to mark a specific example of the structure or component corresponding to the reference numeral. Therefore, it should be understood that components sharing the same name and / or the same reference numerals can share any properties and / or characteristics disclosed herein, even when certain such components are not specifically described and / or mentioned herein. It should be further understood that such components sharing the same name and / or the same reference numerals can share any properties and / or characteristics in examples in which such same reference numerals do not include letter labels. As an example, Fig.11 The quick release suture mechanism 302, Figure 8 The quick release suture mechanism 302a, Fig. 9 The quick release suture mechanism 302b, FIG. 10A to FIG. 10D The quick release suture mechanism 302c, FIG. 14A to FIG. 14B A quick release suture mechanism 302d, and / or FIG. 15A to FIG. 15G and Figures 15J to 15K The quick release suture mechanism 302e can share any suitable properties and / or characteristics with each other. In addition, in the present disclosure, the features and / or attributes of multiple examples (e.g., examples indicated by reference numerals including corresponding letter labels) can be presented and / or discussed with reference to the corresponding reference numerals lacking letter labels.

[0158] The tensioner housing 350 includes a suture entry port 352 and a suture exit port 354, such that the release suture 236 extends into the tensioner housing 350 via the suture entry port 352 and extends out of the tensioner housing 350 via the suture exit port 354. More specifically, the release suture 236 extends between the implantable device and the reel 340 via the suture entry port 352, and the release suture 236 extends between the reel 340 and the quick release suture mechanism 302 via the suture exit port 354.

[0159] like Figure 7 As shown, the suture lock assembly 300 and / or the suture entry port 352 can be configured to be operatively coupled to the delivery device connector 306 of the delivery device 200. Thus, the suture lock assembly 300 can be configured such that the release suture 236 extends between the reel 340 and the implantable device via the delivery device connector 306. As an example, the delivery device connector 306 can represent and / or include Figure 6B A portion of branch 244 of adapter 240 is shown.

[0160] like Figure 7 As shown, the quick release suture mechanism 302 includes a quick release docking port 304 and a suture anchoring cap 320, wherein the quick release docking port is configured to be attached to the suture exit port 354, and the suture anchoring cap is configured to be selectively coupled to and detached from the quick release docking port 304. The quick release suture mechanism 302 is configured to selectively switch between a locked configuration and an unlocked configuration.

[0161] The quick-release suture mechanism 302 is in a locked configuration when the suture anchoring cap 320 is operatively coupled to the quick-release docking port 304. In the locked configuration, the quick-release suture mechanism 302 holds the release suture 236 in a fixed position relative to the suture exit port 354 and / or relative to the quick-release docking port 304, such as to limit and / or prevent the release suture 236 from being removed from the suture lock assembly 300 or the implantable device.

[0162] The quick release suture mechanism 302 is in an unlocked configuration when the suture anchoring cap 320 is removed from the quick release docking port 304. In the unlocked configuration, the release suture 236 can be removed from the suture exit port 354 and / or the quick release docking port 304, such as to enable the release suture 236 to be removed from the implantable device.

[0163] In this manner, the quick release docking port 304 can facilitate removal of the release suture 236 from the implantable device without removing the suture lock assembly 300 from the delivery device connector 306 and / or without cutting the release suture. That is, removing the suture anchoring cap 320 from the quick release docking port 304 provides the ability to access and remove the release suture 236 while the suture lock assembly 300 remains coupled to the delivery device connector 306, as compared to a suture lock assembly that is configured to be removed from a hub assembly in order to access and cut the release suture.

[0164] The quick release docking port 304 may be part of the tensioner housing 350, or may be a component operatively coupled to the tensioner housing 350. For example, the quick release docking port 304 and the suture exit port 354 may be integrally formed and / or may refer to a common (e.g., identical) component.

[0165] When the quick release suture mechanism 302 is in the locked configuration, the suture lock assembly 300 can be used with FIG. 6A to FIG. 6D The suture lock assembly 216 of the quick release suture mechanism 302 operates substantially similarly. For example, when the quick release suture mechanism 302 is in the locked configuration, rotating the spool 340 relative to the tensioner housing 350 can be used to wind a portion of the release suture 236 around the spool 340 to increase the tension in the release suture 236 and / or reduce the length of the release suture 236 between the suture lock assembly 300 (and / or its suture access port 352) and the implantable device.

[0166] However, with FIG. 6A to FIG. 6D The example is different. Figure 7 The release suture 236 in the example of FIG. 3 does not terminate at the reel 340, but passes through each of the suture entry port 352 and the suture exit port 354. Specifically, in FIG. Figure 7 In the example of , the quick release suture mechanism 302 is configured such that the release suture 236 extends from the quick release docking port 304 through the suture exit port 354 and continues through the suture entry port 352 to the implantable device and returns to the quick release docking port 304 via the suture entry port 352 and the suture exit port 354.

[0167] The suture anchoring cap 320 can be configured to be operatively coupled to the quick release docking port 304 in any of a variety of ways. Figure 7 As shown, the quick-release suture mechanism 302 may include a docking port coupling mechanism 310 configured to selectively couple the suture anchoring cap 320 to the quick-release docking port 304. In particular, one or both of the suture anchoring cap 320 and / or the quick-release docking port 304 may include at least a portion of the docking port coupling mechanism 310.

[0168] In some examples, such as Figures 8 to 10D In an example of, the docking port coupling mechanism 310 includes a port thread 312 (e.g., an external thread) and a cap thread 322 (e.g., an internal thread), and the port thread and the cap thread are configured to threadably engage with each other to selectively couple the suture anchoring cap 320 to the quick release docking port 304. Specifically, in such examples, the quick release docking port 304 includes a port thread 312, and the suture anchoring cap 320 includes a cap thread 322. Thus, in such examples, the quick release suture mechanism 302 can be selectively converted from a locked configuration to an unlocked configuration by unscrewing the suture anchoring cap 320 from the quick release docking port 304. The pitch of the port thread 312 and / or the cap thread 322 can be configured to allow the suture anchoring cap 320 to be removed from the quick release docking port 304 via a desired number of turns (e.g., less than one turn, one turn, or more than one turn) of the suture anchoring cap 320 relative to the quick release docking port 304. Although Figures 8 to 10D The port threads 312 are shown as external threads and the cap threads 322 are shown as internal threads, but it is within the scope of the present disclosure that the port threads 312 can be internal threads and the cap threads 322 can be external threads.

[0169] In other examples, such as FIG. 15A to FIG. 15G and FIG. 15I to FIG. 15M In the example of, the docking port coupling mechanism 310 may include and / or may be a bayonet lock coupling mechanism. FIG. 15A to FIG. 15G and FIG. 15I to FIG. 15M In the example of , the docking port coupling mechanism 310e includes a bayonet pin 314e and a bayonet slot 324e, the bayonet slot being configured to receive the bayonet pin 314e in a bayonet lock configuration. FIG. 15A to FIG. 15G and FIG. 15I to FIG. 15M In the example of the quick release docking port 304e, the quick release docking port 304e includes a bayonet pin 314e, and the suture anchoring cap 320e includes a bayonet slot 324e. However, in other examples, the quick release docking port 304 may include a bayonet slot 324, and the suture anchoring cap 320 may include a bayonet pin 314. The bayonet coupling mechanism may, for example, allow the suture anchoring cap 320 to release the suture anchoring cap 320 by rotating less than one turn (e.g., 1 / 4 turn, 1 / 2 turn, etc.) relative to the quick release docking port 304.

[0170] Thus, in such examples, the quick release suture mechanism 302 may be selectively transitioned from a locked configuration to an unlocked configuration by sequentially rotating the suture anchoring cap 320 relative to the quick release docking port 304 and axially translating the suture anchoring cap 320 away from the quick release docking port 304 .

[0171] This two-stage removal mechanism can prevent the suture anchor cap 320 from being accidentally removed from the quick-release docking port 304. Additional or alternative examples of mechanisms for reducing the likelihood of accidental removal of the suture anchor cap 320 from the quick-release docking port 304 can include a two-stage removal mechanism (e.g., a grenade pin mechanism, a locking ratchet, a removable physical lock, etc.), a physical barrier, a visual indicator, etc.

[0172] In some examples where the docking port coupling mechanism 310 includes a bayonet lock coupling mechanism, the docking port coupling mechanism 310 includes one or more features to retain the suture anchoring cap 320 in engagement with the quick-release docking port 304. For example, as discussed in more detail below, the docking port coupling mechanism 310e may include one or more features to urge the suture anchoring cap 320e axially outward relative to the quick-release docking port 304e, such as to ensure that the bayonet pin 314e remains engaged with the bayonet slot 324e.

[0173] In some examples, and at least as FIG. 10A to FIG. 10C , FIG. 15A to FIG. 15G and FIG. 15I to FIG. 15M As shown, the suture anchoring cap 320 includes a gripping feature 328 configured to facilitate gripping of the suture anchoring cap 320 to transition the quick-release suture mechanism 302 between the locked configuration and the unlocked configuration. The gripping feature 328 may include and / or may be any suitable feature, examples of which include a textured surface, a dimple, a protrusion, a knob, a lever, a handle, a tab, etc.

[0174] In particular, FIG. 10A to FIG. 10C An example is shown in which the gripping feature 328c includes a set of raised ridges to facilitate unscrewing the suture anchoring cap 320 from the quick release docking port 304. FIG. 15A to FIG. 15G and FIG. 15I to FIG. 15M In the example of FIG. 3 , the gripping feature 328 e includes a tab configured to facilitate actuation of a bayonet lock mechanism of the docking port coupling mechanism 310 e .

[0175] The suture anchoring cap 320 can have any of a variety of structures and / or configurations. In some examples, and as Figure 7As shown, the suture anchoring cap 320 includes an inner plug 332 that is at least partially received within the quick-release docking port 304 when the quick-release suture mechanism 302 is in the locked configuration. The suture anchoring cap 320 may additionally include an outer skirt 334 that circumferentially surrounds the inner plug 332 and extends circumferentially around the quick-release docking port 304 when the quick-release suture mechanism 302 is in the locked configuration. In such examples, the suture anchoring cap 320 may also include an annular channel 336 defined between the inner plug 332 and the outer skirt 334, such that the annular channel 336 receives at least a portion of the quick-release docking port 304 when the quick-release suture mechanism 302 is in the locked configuration.

[0176] In one example where the docking port coupling mechanism 310 includes a threaded coupling, and as Figures 8 to 9 As shown, the inner surface of the outer skirt 334 may include and / or define the cap threads 322, and the outer surface of the quick release docking port 304 may include and / or define the port threads 312. In other examples, the inner plug 332 may include and / or define the cap threads 322, and / or the inner surface of the quick release docking port 304 may include and / or define the port threads 312.

[0177] The suture anchoring cap 320 can be configured to be operatively coupled to the release suture 236 in any of a variety of ways. In particular, in various examples, the release suture 236 extends between and terminates at the suture anchoring end 237 and the suture free end 238, and the suture anchoring cap 320 includes a suture anchoring position 326, and the suture anchoring end 237 is configured to be coupled at the position. Specifically, the suture anchoring cap 320 is configured to be operatively coupled to the suture anchoring end 237 at the suture anchoring position 326, so that during the operational use of the quick-release suture mechanism 302 (e.g., when the quick-release suture mechanism 302 is in a locked configuration or an unlocked configuration), the suture anchoring end 237 is restricted from being removed from the suture anchoring cap 320.

[0178] In some examples, the suture anchoring end 237 is fixedly coupled to the suture anchoring location 326, such as via an adhesive, a cement, a mechanical coupler, a tie-down coupler, a mechanical embolization (e.g., between a knot in the release suture 236 and a smaller hole in the suture anchoring cap 320), and / or other means for fixedly coupling the suture anchoring end 237 to the suture anchoring location 326.

[0179] As used herein, the suture anchoring end 237 and / or the suture free end 238 may refer to the respective ends of the release suture 236, or may refer to the respective portions of the release suture 236 extending proximate to these ends. Thus, for example, the suture anchoring end 237 and / or the suture free end 238 may be described as being attached to another component when the region of the release suture 236 proximate to such ends is attached to the other component.

[0180] The quick-release suture mechanism 302 is generally configured such that when the quick-release suture mechanism 302 is in the locked configuration, the suture free end 238 is fixed in position. In particular, when the quick-release suture mechanism 302 is in the locked configuration, the suture free end 238 is at least substantially fixed in position relative to the quick-release docking port 304. This configuration can be used to prevent the release suture 236 from being removed from the quick-release suture mechanism 302 or from the implantable device before the quick-release suture mechanism 302 is converted to the unlocked configuration.

[0181] Alternatively, when the quick release suture mechanism 302 is in the unlocked configuration, the suture free end 238 is free to move through the quick release docking port 304. Thus, when the quick release suture mechanism 302 is in the unlocked configuration, the release suture 236 can be removed from the implantable device by withdrawing the entire release suture 236 from the suture lock assembly 300, from the delivery apparatus 100, and / or from the implantable device.

[0182] When the quick-release suture mechanism 302 is in the locked configuration, the quick-release suture mechanism 302 can be configured to engage the suture free end 238 in any suitable manner. Figure 7 As shown, when the quick release suture mechanism 302 is in the locked configuration, the suture free end 238 can be inserted between the quick release docking port 304 and the suture anchoring cap 320. As a more specific example, the suture free end 238 can be clamped between the quick release docking port 304 and the inner plug 332 and / or between the quick release docking port 304 and the outer skirt 334.

[0183] As a more specific example, such as in Figure 8 In the example of , the quick release suture mechanism 302 is configured such that when the quick release suture mechanism 302 is in the locked configuration, the suture free end 238 extends between the port thread 312 and the cap thread 322. Therefore, in such examples, the suture free end 238 can be locked in place via the threaded engagement between the port thread 312 and the cap thread 322.

[0184] In some examples (see, for example, Figures 7 to 10D ), the suture anchoring cap 320 defines an inner hole 330 extending at least partially through the suture anchoring cap 320. In particular, Figures 7 to 9Several examples are shown in which the inner hole 330 extends completely through the length of the suture anchoring cap 320, while FIG. 10A to FIG. 10D An example is shown in which the inner bore 330 extends only partially through the suture anchoring cap 320. In some examples, the inner plug 332 defines at least a portion of the inner bore 330.

[0185] In some examples, the suture anchor end 237 and / or the suture free end 238 can extend at least partially through the inner hole 330. In some examples (e.g., see Figures 7 to 9 ), the inner hole 330 can include a suture anchoring location 326. For example, the suture anchoring end 237 can be fixedly coupled to the suture anchoring cap 320 at a location on the inner surface of the suture anchoring cap 320 that defines the inner hole 330 (e.g., via an adhesive, cement, and / or any other suitable bonding means). Additionally or alternatively, and as described in more detail below, the inner hole 330 can include one or more geometric features (e.g., a constriction, a bend, etc.) that serve as a suture anchoring location 326 by at least partially restricting the release suture 236 from being removed from the inner hole 330.

[0186] In some examples, and as Figures 7 and 8 As shown, the quick-release suture mechanism 302 is configured such that when the quick-release suture mechanism 302 is in the locked configuration, the suture free end 238 extends at least substantially to the exterior of the inner bore 330. In particular, in some such examples, the suture free end 238 extends from the suture exit port 354 through the quick-release docking port 304, around the outer surface of the inner plug 332, and through the annular channel 336, such that the suture free end 238 extends away from the interface between the suture anchoring cap 320 and the quick-release docking port 304. Thus, in such examples, although a portion of the suture free end 238 may enter the inner bore 330, the suture free end 238 may not be configured to be accessible via the inner bore 330 when the quick-release suture mechanism 302 is in the locked configuration.

[0187] In other examples, the quick-release suture mechanism 302 can be configured such that when the quick-release suture mechanism 302 is in the locked configuration, the suture free end 238 at least partially extends through the inner hole 330. For example, and as Fig. 9 As shown, the suture free end 238 may extend from the suture exit port 354 through the inner bore 330 , around the outer skirt 334 , around one end of the quick release docking port 304 , into the annular channel 336 , and through the inner bore 330 again.

[0188] Alternatively, the suture free end 238 may extend from the suture exit port 354 and around one end of the quick release docking port 304 via the annular channel 336 , around the outer skirt 334 , and through the inner bore 330 .

[0189] In each of these examples, and similar to Figure 8 For example, when the quick release suture mechanism 302 is in the locked configuration, the suture free end 238 can be captured between the port threads 312 and the cap threads 322.

[0190] In some examples, the suture anchoring cap 320 can define a plurality of inner holes 330. For example, and as FIG. 15I to FIG. 15K As shown, the inner hole 330 can be a first inner hole 330, and the suture anchoring cap 320 can also include a second inner hole 331. In such examples, the suture anchoring end 237 can at least partially extend through the first inner hole 330, and / or the suture free end 238 can at least partially extend through the second inner hole 331 (e.g., when the quick release suture mechanism is in a locked configuration).

[0191] Each of the suture anchoring end 237 and the suture free end 238 can be operatively coupled to the suture anchoring cap 320 in any of a variety of ways. Fig.15J As shown, the suture anchoring end 237 can extend through the first inner hole 330e and terminate in a knot. In this way, the knotted end of the suture anchoring end 237 can fit in the recess at the suture anchoring position 326e, but may be too large to pass through the first inner hole 330e.

[0192] As another example, and if Figure 15K As shown, the suture anchoring end 237 can extend through the first inner hole 330e and continue around the exterior of the inner plug 332e so as to be tied and / or otherwise attached to a portion of the release suture 236 to secure the suture anchoring end 237 to the suture anchoring cap 320e.

[0193] In other examples, the suture anchoring end 237 may additionally or alternatively be attached (eg, with an adhesive, with a screw, etc.) to the suture anchoring location 326 , the first inner hole 330 , and / or the suture anchoring cap 320 .

[0194] The suture free end 238 may also be secured in position relative to the suture anchoring cap 320 in any of a variety of ways. Figures 15A to 15M In the example, and as Fig.15E and Figures 15J to 15M As shown, the docking port coupling mechanism 310e includes a pair of bayonet pins 314e, at least one of which terminates in a pin cap 315e having a wider diameter than the remainder of the bayonet pin 314e. Figures 15J to 15MIn the example of the present invention, the suture free end 238 can be wrapped around the bayonet pin 314e so that the pin cap 315e limits the suture free end 238 from falling off one end of the bayonet pin 314e. In other words, in such examples, the pin cap 315e can be used to keep the release suture 236 on the bayonet pin 314e. However, this is not required in all examples, and in addition, it is also within the scope of the present disclosure that the suture free end 238 can be fully kept on the bayonet pin 314e without the pin cap 315e and / or without engaging the pin cap 315e.

[0195] Additionally or alternatively, and if Fig.15E and Figures 15J to 15M As shown, at least one bayonet pin 314e can include a transverse pin hole 317e extending through the diameter of the bayonet pin 314e. In such examples, and as shown in FIG. Figures 15J to 15K As shown, the release suture 236 and / or its suture free end 238 can extend through the transverse pin hole 317e to at least partially hold the suture free end 238 in place relative to the bayonet pin 314e.

[0196] Additionally or alternatively, in some examples, the suture free end 238 can be wound around each of the pair of bayonet pins 314e. For example, the suture free end 238 can be wound around the first bayonet pin 314e, around one end of the quick release docking port 304e, and around the second bayonet pin 314e. In such examples, the suture free end 238 can be wound around the quick release docking port 304e and the bayonet pin 314e in an 8-shaped pattern. Further within the scope of the present disclosure, any other suitable pattern or configuration can be used to wrap the suture free end 238 around one or more components of the quick release suture mechanism 302, such as to achieve a desired suture retention strength.

[0197] In some examples, and as Figures 15J to 15L As shown, when the quick release suture mechanism 302e is in the locked configuration, the suture free end 238 of the release suture 236 can extend through the second inner hole 331e and through the annular channel 336e to be wrapped around the bayonet pin 314e. In some such examples, when the quick release suture mechanism 302e is in the locked configuration, the engagement between the suture free end 238 and one or both of the bayonet pin 314e and the bayonet slot 324e is sufficient to hold the suture free end 238 in place.

[0198] In other examples, and as Figure 15M As shown, when the quick release suture mechanism 302e is in the locked configuration, the suture free end 238 of the release suture 236 can extend through the inner hole 331e and through the annular channel 336e (eg, Figures 15J to 15K314e) and can extend outside of the outer skirt 334e to wrap around the outer skirt 334e and continue back to the bayonet pin 314e. The suture free end 238 can further extend through the annular channel 336e between the outer skirt 334e and the quick release docking port 304e. In this way, the suture free end 238 can be clamped between the outer skirt 334e and the quick release docking port 304e, and / or can be tensioned between the edge of the outer skirt 334e and the bayonet pin 314e to further fix the suture free end 238 relative to the bayonet pin 314e.

[0199] In some examples, at least when the quick-release suture mechanism 302 is in the locked configuration, the suture free end 238 can be additionally or alternatively fixedly coupled to the suture anchoring cap 320, and / or can remain attached to the suture anchoring cap 320 when the suture anchoring cap 320 is removed from the quick-release docking port 304. In such examples, after the suture anchoring cap 320 is removed from the quick-release docking port 304, the release suture 236 can be removed from the suture lock assembly 300 / 400 and / or the delivery device 200 by severing the release suture 236. Thus, in such examples, the unlocked configuration of the quick-release suture mechanism 302 can correspond to a configuration in which the suture anchoring cap 320 is removed from the quick-release docking port 304, and in which the suture free end 238 is subsequently removed from the suture anchoring cap 320.

[0200] In other examples, you can use FIG. 15A to FIG. 15I The quick release suture mechanism 302e of the embodiment of the present invention can be configured so that the suture free end 238 does not extend through the second inner hole 331e and / or is not directly connected to the suture anchoring cap 320e, as described above. For example, at least when the quick release suture mechanism 302e is in the locked configuration, the suture free end 238 can be additionally or alternatively connected to the bayonet pin 314e of the quick release docking port 304e (e.g., wrapped around the bayonet pin). Therefore, in such examples, the quick release suture mechanism 302e can be converted from the locked configuration to the unlocked configuration by first disengaging (e.g., untying) the suture free end 238 from the bayonet pin 314e.

[0201] In some examples, and as Figure 7 As shown, the quick-release suture mechanism 302 includes a gasket 316 configured to form an at least substantially fluid-tight seal to limit leakage from the quick-release docking port 304. In particular, in some examples, the gasket 316 is configured to form a substantially fluid-tight seal between the suture anchoring cap 320 and the quick-release docking port 304 when the quick-release suture mechanism 302 is in the locked configuration. In some examples, the gasket 316 can be positioned within the suture exit port 354 and / or within the quick-release docking port 304.

[0202] Additionally or alternatively, in some examples, the gasket 316 can be configured to restrict fluid flow out of the quick-release docking port 304 when the quick-release suture mechanism 302 is in the unlocked configuration. That is, when the suture anchoring cap 320 is removed from the quick-release docking port 304, the quick-release docking port 304 can form a leak path away from the delivery device 200. To mitigate this, the gasket 316 can be used to restrict and / or prevent blood, saline, and / or other fluids from flowing out of the quick-release docking port 304 when the suture anchoring cap 320 is removed.

[0203] In some examples, the gasket 316 can include and / or can be a gasket that opens when compressed, such as a gasket commonly used in needleless valves. In such examples, the gasket 316 can be open to fluid flow when the suture anchoring cap 320 is operatively coupled to the quick-release docking port 304, and the gasket 316 can be closed to fluid flow when the suture anchoring cap 320 is removed from the quick-release docking port 304.

[0204] As another example, the washer 316 may include and / or may be a Tuohy-Borst washer that compresses and closes when the suture anchoring cap 320 is operatively coupled to the quick-release docking port 304 and that opens slightly when the suture anchoring cap 320 is removed from the quick-release docking port 304. In such examples, the washer 316 opening slightly may facilitate pulling the release suture 236 through the washer 316.

[0205] In one example where the docking port coupling mechanism 310 includes a bayonet pin 314 and a bayonet slot 324, the washer 316 can additionally help maintain the quick release suture mechanism 302 in a locked configuration. For example, when the quick release suture mechanism 302e is in a locked configuration, and as Fig.15E As shown, the suture anchoring cap 320e can slightly compress the washer 316e so that the washer 316e pushes the suture anchoring cap 320e axially outward, thereby pushing the bayonet pin 314e to engage with the bayonet slot 324e. In other words, when the quick-release suture mechanism 302e is in a locked configuration, the washer 316e can push the suture anchoring cap 320e axially outward to maintain the engagement between the bayonet pin 314e and the bayonet slot 324e. In this way, the washer 316e can also introduce a two-stage removal mechanism into the quick-release suture mechanism 302e by requiring the user to push the suture anchoring cap 320e axially inward against the outward force of the washer 316e before rotating the suture anchoring cap 320e relative to the quick-release docking port 304e.

[0206] In addition, and if Figures 15J to 15MAs shown, in one example where the suture free end 238 of the release suture 236 is wrapped around the bayonet pin 314e, the action of the washer 316e pushing the bayonet pin 314e to engage with the bayonet slot 324e can also be used to clamp the release suture 236 between the bayonet pin 314e and the bayonet slot 324e. In this way, when the quick release suture mechanism 302e is in a locked configuration, the action of the washer 316e pushing the bayonet pin 314e to engage with the bayonet slot 324e can be used to fix the suture free end 238 of the release suture 236 in an appropriate position.

[0207] Additionally or alternatively, in some examples, and as Figures 15L to 15M As shown, a portion of the bayonet slot 324e can extend toward the quick-release docking port 304e (e.g., when the quick-release suture mechanism 302e is in the locked configuration) to define a recess for receiving the bayonet pin 314e. Thus, in such examples, the suture anchoring cap 320e may need to be pushed axially inward against the washer 316e before rotating and subsequently removing the suture anchoring cap from the quick-release docking port 304e.

[0208] In some examples, and as Figure 7 As shown, the quick-release suture mechanism 302 additionally includes one or more suture centralizers 358 configured to guide the release suture 236 through the tensioner housing 350. For example, when present, each suture centralizer can be configured to engage the tensioner housing 350 (e.g., within the suture entry port 352 or within the suture exit port 354) and support the release suture 236 through its central hole or channel to maintain at least a portion of the release suture 236 away from the inner surface of the tensioner housing 350. In some examples, the gasket 316 can operate as a suture centralizer 358.

[0209] like Figure 7 As further shown in , the stitch lock assembly 300 can additionally include a flushing port 360 that is fluidly coupled to the suture entry port 352 for supplying flushing fluid into the tensioner housing 350 and / or to a downstream portion of the delivery device 200. In some such examples, the tensioner housing 350 at least partially defines the flushing port 360. In particular, because the quick-release suture mechanism 302 enables the release suture 236 to be removed from the implantable device without removing the stitch lock assembly 300 from the delivery device connector 306, flushing fluid can be delivered to the delivery device 200 via the tensioner housing 350 without losing hemostasis.

[0210] When present, the flush port 360 may include and / or may be any suitable port and / or coupling, such as a port that is nominally sealed and open when another component (e.g., a flushing fluid source) is operatively coupled to the flush port 360. In some examples, the flush port 360 may include and / or may be a Luer lock port and / or an exchangeable Luer lock port.

[0211] FIG. 10A to FIG. 10D An exemplary process by which the release suture 236 may be withdrawn from the quick release suture mechanism 302c is sequentially shown. Specifically, Fig. 10A The suture anchoring cap 320c is shown operatively coupled to the quick release docking port 304c such that the quick release suture mechanism 302c is in a locked configuration.

[0212] Fig. 10B The suture anchoring cap 320c is shown removed from the quick release docking port 304c, so that the quick release suture mechanism 302c is in an unlocked configuration. Fig. 10B As shown, the suture anchoring end 237 is fixedly coupled to the suture anchoring cap 320c within the inner bore 330, while the suture free end 238 extends out of the quick release docking port 304c.

[0213] With the suture free end 238 released from the interface between the suture anchoring cap 320c and the quick-release docking port 304c, the suture anchoring cap 320c is pulled away from the quick-release docking port 304c (e.g., pulled to Fig. 10C The suture free end 238 is pulled into the quick release docking port 304c and pulled to the implantable device. As the suture anchoring cap 320c is further pulled, the suture free end 238 can be completely withdrawn from the implantable device and the quick release docking port 304c, such as Fig. 10D shown.

[0214] Although the foregoing description of the suture anchoring cap 320 generally relates to examples in which the suture lock assembly 216 / 300 includes a reel 278 / 340 to apply tension to the release suture 236, this is not required in all examples. Fig.11 An example of a suture lock assembly 400 is shown that includes a suture tensioner 402 to engage and selectively apply tension to a release suture 236 attached to an implantable device, such as a docking device 70. The suture anchoring cap 320 may also be used with other delivery assemblies in which an implantable device is releasably coupled to a delivery device via one or more sutures. For example, and as discussed above, the suture anchoring cap 320 may be used in conjunction with a docking device delivery device 50 and / or a prosthetic valve delivery device 60 that lacks a mechanism for adjusting the slack of the release suture 236.

[0215] The stitch lock assembly 400 may include any features, characteristics, properties, etc. disclosed herein with reference to the stitch lock assembly 216 and / or the stitch lock assembly 300, and vice versa. Specifically, Fig.11 An example is shown in which the stitch lock assembly 400 includes the stitch lock assembly 400 described above. Figures 7 to 10D The quick release suture mechanism 302 is discussed.

[0216] Although the present disclosure as a whole relates to examples in which the stitch lock assembly 400 is used in conjunction with the release suture 236, this is not required, and in addition, the stitch lock assembly 400 can be used in conjunction with any suitable suture and is also within the scope of the present disclosure. For example, the stitch lock assembly 400 can be used in conjunction with a suture that is not configured to be coupled to an implantable device and / or release an implantable device. Therefore, as used herein, the release suture 236 can additionally or alternatively be referred to as a suture 236.

[0217] like Fig.11 As shown, the suture lock assembly 400 includes a tensioner housing 450 that at least partially receives the suture tensioner 402. The tensioner housing 450 includes a suture entry port 452 so that the release suture 236 extends between the implantable device and the suture tensioner 402 via the suture entry port 452. In some examples, and as shown in FIG. Fig.11 As shown, the tensioner housing 450 additionally includes a suture exit port 454 such that the release suture 236 extends through the tensioner housing 450 between the suture entry port 452 and the suture exit port 454 .

[0218] like Fig.11 As shown, the suture lock assembly 400 and / or the suture entry port 452 can be configured to be operatively coupled to the delivery device connector 306 of the delivery device 200. Thus, the suture lock assembly 400 can be configured such that the release suture 236 extends between the suture tensioner 402 and the implantable device via the delivery device connector 306. As an example, the delivery device connector 306 can represent Figure 6B A portion of branch 244 of adapter 240 is shown.

[0219] FIG. 12A to FIG. 15M A more specific example of a stitch lock assembly 400 and / or its components is shown, as described in more detail below. Specifically, FIG. 12A to FIG. 12G A first exemplary stitch lock assembly 400a is shown, while Fig.13 A second exemplary stitch lock assembly 400b is shown. FIG. 14A to FIG. 14B A third exemplary suture lock assembly 400c is shown incorporating a fourth exemplary quick release suture mechanism 302d, and FIG. 15A to FIG. 15MA fourth exemplary suture lock assembly 400d is shown in combination with a fifth exemplary quick release suture mechanism 302e. Fig.11 The disclosed features, characteristics, properties, etc. of the stitch lock assembly 400 may also be understood to be applicable to any stitch lock assembly 400a / 400b / 400c / 400d, and vice versa.

[0220] return Fig.11 , the suture tensioner 402 of the suture lock assembly 400 is configured to selectively rotate relative to the tensioner housing 450 about the tensioner central axis 404. Specifically, the suture tensioner 402 includes a pair of spaced-apart posts 430 connected to each other via a connector 420 (e.g., an arm, a hub, a disk, a wheel, etc.), such that the posts 430 are configured to rotate in unison about the tensioner central axis 404 as the suture tensioner 402 rotates. In some examples, the posts 430 and / or the connector 420 may be collectively referred to as a fork-type tensioning mechanism.

[0221] As the suture tensioner 402 moves relative to the tensioner housing 450 in a first direction (eg, Fig.11 4 (counterclockwise in the example of the embodiment of the present invention), the post 430 engages and collects (e.g., wraps) a certain length of the release suture 236 to selectively increase the length of the release suture 236 enclosed by the tensioner housing 450, thereby selectively increasing the tension in the release suture 236. In some examples, the suture lock assembly 400 can be configured so that the release suture 236 extends from the suture tensioner 402 through the suture entry port 452 to the implantable device and returns to the suture tensioner 402 via the suture entry port 452. Therefore, in such examples, rotating the suture tensioner 402 in a first direction to increase the length of the release suture 236 contained in the tensioner housing 450 is used to increase the tension in the release suture 236 between the suture tensioner 402 and the implantable device.

[0222] In the case where the suture 236 is released in a tensioned state after the suture tensioner 402 is rotated in a first direction, the suture tensioner 402 is rotated in a second direction opposite to the first direction (e.g., Fig.11 Rotating the suture tensioner 402 (in the example of the second direction) is used to gradually release the tension in the release suture 236. As the suture tensioner 402 is rotated in the second direction, the release of tension can allow slack to form in the release suture 236. For example, if the tension applied by the suture tensioner 402 is released, and if no external tension is used to pull the release suture 236 out of the tensioner housing 450 via the suture entry port 452, the slack release suture 236 can remain within the tensioner housing 450. As discussed in more detail below, the spaced-apart configuration of the posts 430 can allow the slack release suture 236 to occupy the tensioner housing 450 and / or re-assume a tensioned configuration with minimal risk of entanglement.

[0223] In some examples, such as Fig.11 As shown and discussed in more detail below, the suture lock assembly 400 and / or the suture tensioner 402 are configured to be used in conjunction with the quick release suture mechanism 302 and / or the suture anchoring cap 320 disclosed herein. Specifically, in some such examples, the quick release suture mechanism 302 is coupled to and / or combined with the suture exit port 454. In such examples, the suture lock assembly 400 can be described as being similar to and / or identical to the example of the suture lock assembly 300 in which the spool 340 is replaced by the suture tensioner 402 as described herein.

[0224] However, in other examples, the suture lock assembly 400 and / or the suture tensioner 402 may not be configured for use with the quick release suture mechanism 302 and / or the suture anchoring cap 320. Specifically, in some examples, the tensioner housing 450 may lack a suture exit port 454, and / or a portion of the release suture 236 may be fixedly coupled to one of the posts 430. For example, the release suture 236 may extend between and terminate at a first end and a second end, at least one of which is fixedly coupled to a corresponding suture anchoring location 440 of the suture tensioner 402. Fig.11 As shown, at least one post 430 may include and / or define such a suture anchoring location 440 .

[0225] Each post 430 can have any suitable shape and / or configuration for engaging a release suture 236 as described herein. Figures 11 to 12G , Fig.14A and FIG. 15D to FIG. 15H As shown, each post 430 is substantially cylindrical, having a circular cross-sectional shape.

[0226] However, this is not required in all examples, and in addition, each column 430 can have any of a variety of shapes and is also within the scope of the present disclosure. Fig.13 As shown and described in more detail below, each post 430 can have an asymmetrical shape, such as a yin-yang shape.

[0227] As additional examples, each post 430 may have a conical and / or frustoconical shape, and / or may have a curved, circular, oval, and / or elliptical cross-sectional shape.

[0228] Additionally, while the present disclosure generally relates to examples in which posts 430 are at least substantially identical to one another (eg, in shape and / or size), it is within the scope of the present disclosure for the posts 430 to differ in shape and / or size.

[0229] Fig.11 A configuration is shown in which the suture tensioner 402 applies tension to the release suture 236, while FIG. 12A to FIG. 12G A series of events is shown in which the suture tensioner 402a applies increased tension to the release suture 236 and then releases the tension.

[0230] The suture tensioner 402 may be described as transitioning between a plurality of tensioner configurations to selectively apply tension to the released suture 236. For example, rotating the suture tensioner 402 relative to the tensioner housing 450 may be described as being used to transition the suture tensioner 402 between a plurality of tensioner configurations defined between and including a released configuration and a fully tensioned configuration.

[0231] In the release configuration, the post 430 is positioned to exert no force (or negligible force) on the release suture 236. For example, when the suture tensioner 402 is in the release configuration, and as Fig. 12A As shown, one or both of the posts 430 may be spaced apart from, or may be tangential to, the straight line connecting the suture entry port 452 and the suture exit port 454. Fig. 12A One configuration is shown in which the release suture 236 extends between the suture entry port 452a and the suture exit port 454a and in which each post 430 is spaced apart from the release suture 236.

[0232] In various examples, any of a plurality of rotational orientations of the suture tensioner 402 relative to the tensioner housing 450 in which the post 430 is spaced apart from a straight line connecting the suture entry port 452 and the suture exit port 454 may be described as representing a released configuration.

[0233] Step by step sequentially FIG. 12A to FIG. 12E In the illustrated configuration, it can be seen that rotating the suture tensioner 402a relative to the tensioner housing 450a (in a counterclockwise direction in this example) serves to engage the post 430a with the release suture 236. As the suture tensioner 402a continues to rotate, the post 430a winds up an increasing length of the release suture 236, such that the length of the release suture 236 extending between the suture entry port 452a and the suture exit port 454a increases. This can be used to add tension in the release suture 236, such as when the distal portion of the release suture 236 is coupled to an implantable device that is axially fixed in position relative to the suture lock assembly 400. Fig.12E The fully tensioned configuration of suture tensioner 402a is shown, wherein post 430a is positioned to engage the release suture to create maximum tension in release suture 236 when release suture 236 is coupled to an implantable device.

[0234] FIG. 12E to FIG. 12G 4 shows a sequence of events in which, starting from a fully tensioned configuration, the suture tensioner 402a is rotated relative to the tensioner housing 450a (in this example, in a clockwise direction) to reduce the tension in the release suture 236. In particular, when the distal end of the release suture 236 is coupled to an implantable device that is not subject to distal guide forces, the suture tensioner 402a is rotated from Fig.12E The fully tensioned configuration is oriented toward Figure 12G Rotation into the release configuration allows slack to be created in the release suture 236.

[0235] like FIG. 12F to FIG. 12G As shown, since the posts 430a used to tension the release suture 236 are spaced apart from each other, the space between the posts 430a can allow the release suture 236 to release its tension with a lower risk of entanglement. Specifically, in this example, since the release suture 236 is not subjected to distal guiding forces (i.e., guided out of the tensioner housing 450a via the suture entry port 452a), the length of the release suture 236 contained in the tensioner housing 450a will remain substantially unchanged as the tension applied by the suture tensioner 402a is released.

[0236] like Figure 12G As shown, the spaced-apart columns 430a can provide sufficient volume for the release suture 236 to be deployed without becoming tangled with itself. In particular, and as shown Figures 11 to 13 As shown, the tensioner housing 450 may include and / or define a tensioner chamber 422 that encloses at least a portion of the posts 430 and a portion of the release suture 236. Specifically, when the suture tensioner 402 is in the release configuration, the release suture 236 is free to occupy the area of ​​the tensioner chamber 422 between the posts 430 without being obstructed by the suture tensioner 402. In other words, the suture lock assembly 400 can be configured such that the suture tensioner 402 can be rotated to a position where the posts 430 are spaced apart from the release suture 236 (e.g., the release configuration).

[0237] Compared to suture lock assemblies that use a reel to apply tension to the released suture, the spaced-apart posts 430 of the suture lock assembly 400 can provide a greater capacity to increase the length of the released suture 236 within the tensioner housing 450 with each rotation of the suture tensioner 402. For example, rotating a reel (e.g., reel 278 or reel 340) a half turn will collect a length of the released suture 236 that is approximately equal to half the circumference of the reel. In contrast, and as shown by comparison Fig. 12A and Fig.12E (Discussed in more detail below) It can be seen that rotating the suture tensioner 402 half a turn can collect a length of released suture 236 equal to twice the distance the posts 430 are separated.

[0238] Additionally, the spaced-apart posts 430 of the suture tensioner 402 can provide enhanced stability and / or security for releasing the suture 236 when the suture tensioner 402 is in a fully tensioned configuration relative to a suture lock assembly utilizing a reel. Figure 7 When the spool 340 is used to apply tension to the release suture 236, the release suture 236 will apply a torque on the spool 340, the magnitude of which is equal to the product of the tension in the release suture 236 and the radius of the spool 340. In contrast, and with reference to Fig.12E , when the suture tensioner 402a is in the fully tensioned configuration, the release suture 236 can be at least substantially aligned with the post 430a so that the release suture 236 applies minimal torque to the suture tensioner 402a. Thus, relative to a configuration in which a spool (e.g., spool 278 or spool 340) is used to apply tension to the release suture 236, less force and / or mechanical resistance may be required to maintain the suture tensioner 402a in the fully tensioned configuration (e.g., to counteract the pulling force of the release suture 236).

[0239] As referenced above Fig. 12A and 12G As discussed, when the suture tensioner 402 is in any of a variety of rotational configurations in which the post 430 does not obstruct and / or apply tension to the release suture 236, the suture tensioner 402 can be described as being in a released configuration. Figure 12G As shown, the spaced-apart posts 430a may be positioned, when provided, in any of a variety of rotational configurations corresponding to a released configuration.

[0240] Similarly, the fully tensioned configuration of the suture tensioner 402 may refer to any rotational configuration of the suture tensioner 402 and / or the post 430 relative to the tensioner housing 450 in which the post 430 maximizes the length of the released suture 236 extending within the tensioner housing 450 .

[0241] exist FIG. 12A to FIG. 12G In the example of the embodiment, the suture tensioner 402 is rotated about 180 degrees relative to the tensioner housing 450 to convert the suture tensioner 402 between the released configuration and the fully tensioned configuration. However, this is not required for all examples, and in addition, it is also within the scope of the present disclosure that the suture tensioner 402 can be rotated through any suitable angle to convert between the released configuration and the fully tensioned configuration. As an example, the suture tensioner 402 can be configured to rotate less than 180 degrees, about 180 degrees, greater than 180 degrees, less than 360 degrees, about 360 degrees, and / or greater than 360 degrees relative to the tensioner housing 450.

[0242] In some examples, the suture lock assembly 400 may include one or more features to mechanically limit the range of rotational motion of the suture tensioner 402 and / or define a released configuration and / or a fully tensioned configuration. Fig.11 As shown, the suture lock assembly 400 can include one or more rotator stops 442 fixed in position relative to the tensioner housing 450. In some examples, at least one rotator stop 442 extends into the tensioner chamber 422 and is configured to engage one or both of the posts 430 when the suture tensioner 402 is in a released configuration and / or in a fully tensioned configuration to define the released configuration and / or the fully tensioned configuration.

[0243] Additionally or alternatively, at least one rotator stop 442 can be positioned exterior to the tensioner chamber 422 and / or can be positioned to engage the rotator 410 (discussed in more detail below) of the rotational suture tensioner 402. For example, the rotator 410 can include a rotator stop 442 in the form of a component that cooperates with a corresponding component of the tensioner housing 450 to define a released configuration and / or a fully tensioned configuration. In some examples, the use of a single rotator stop 442 can enable the suture tensioner 402 to be rotated approximately and / or nearly a full rotation before being mechanically restrained by the rotator stop 442. An example of a rotator 410 is shown as FIG. 14A to FIG. 14B The rotator 410c and FIG. 15A to FIG. 15C and FIG. 15E to FIG. 15H rotator 410d; therefore, references herein to rotator 410 may be understood to relate to rotator 410c, rotator 410d, and / or any other examples of rotators described herein.

[0244] Each post 430 can be configured to engage the release suture 236 in any suitable manner. Fig.11 As shown, each post 430 can be described as including a suture engaging surface 432 that engages the release suture 236 during operational use of the suture lock assembly 400 (eg, when the suture tensioner 402 is used to apply tension to the release suture 236).

[0245] In some examples, each suture engagement surface 432 is an outer surface of a corresponding post 430 and / or is otherwise fixed relative to the remainder of the corresponding post 430 and / or relative to the connector 420. Thus, in such examples, the suture tensioner 402 can be configured such that as the suture tensioner 402 rotates relative to the tensioner housing 450, the release suture 236 slides relative to each suture engagement surface 432. That is, in one example in which each suture engagement surface 432 has a fixed orientation relative to the connector 420, rotating the suture tensioner 402 about the tensioner central axis 404 causes each suture engagement surface 432 to rotate about the tensioner central axis 404 and about an axis parallel to the tensioner central axis. Thus, as the post 430 moves to engage the release suture 236, such movement can cause the release suture 236 to slide relative to each suture engagement surface 432.

[0246] In other examples, the suture tensioner 402 can be configured such that as the suture tensioner 402 rotates, the released suture 236 remains in at least substantially static contact with each suture engagement surface 432. As an example, and as Fig.11 As shown, the suture tensioner 402 can include a pair of rollers 438, each roller rotatably coupled to a respective post 430 and each roller including a respective suture engaging surface 432. For example, each roller 438 can circumferentially surround a respective post 430 and / or can be rotatably coupled to the respective post 430 (such as via a bearing).

[0247] As another example, each post 430 can be rotatably coupled to the connector 420. In particular, each post 430 can define a respective suture engaging surface 432, and the entirety (or at least substantially the entirety) of the post 430 can be configured to rotate relative to the connector 420.

[0248] In such examples, each suture engagement surface 432 can rotate relative to the connector 420 such that as the suture tensioner 402 rotates, the suture engagement surface 432 remains in at least substantially static contact with the release suture 236. In other words, in such examples, as the suture tensioner 402 rotates, static friction between the release suture 236 and each suture engagement surface 432 can cause each suture engagement surface 432 to rotate relative to the connector 420 and / or relative to the corresponding post 430. Thus, this configuration can facilitate rotating the suture tensioner 402 to increase or decrease tension in the release suture 236 without causing the post 430 to drag or push the release suture 236 due to sliding friction between the release suture 236 and the suture engagement surface 432.

[0249] In examples where each post 430 is circular, the size (e.g., diameter) of each post 430 can be selected based on any of a variety of considerations. For example, a larger circular post 430 can be used to increase the minimum radius of curvature of the release suture 236 within the suture lock assembly 400, which can be used to avoid localized stress within the release suture 236. In addition, the larger circular post 430 can additionally correspond to the increased length of the release suture 236 that is wrapped by the post 430 as the suture tensioner 402 transitions from the release configuration to the fully tensioned configuration. Alternatively, the smaller circular post 430 can create a correspondingly wide area between the posts 430 for the release suture 236 to expand into when relaxed.

[0250] As discussed above, Fig.13 An example is shown in which each post 430b has an asymmetric yin-yang shape. Fig.13 It may also be described as representing an example where each post 430 has a width at a leading edge 434b (eg, measured along a direction perpendicular to and intersecting the tensioner center axis 404b) that is greater than a width at a trailing edge 436b.

[0251] refer to Fig.13 , each post 430b can be described as including a leading edge 434b and a trailing edge 436b, such that each suture engaging surface 432b extends between the leading edge 434b and the trailing edge 436b of the corresponding post 430b. FIG. 12A to FIG. 12G Compared with the circular column 430a, Fig.13 The yin-yang shape of the posts 430c can provide an elongated suture engagement surface 432c without significantly reducing the open space between the posts 430c. This configuration can be used to distribute the force exerted by each post 430c on the release suture 236 over a greater length of the release suture 236, which can facilitate applying tension to the release suture 236 with the suture tensioner 402c. Additionally or alternatively, this configuration can be used to increase the minimum radius of curvature of the release suture 236 within the suture lock assembly 400c (e.g., relative to FIG. 12A to FIG. 12G The suture lock assembly 400b) can be used to avoid local stress in the released suture 236. In addition, relative to the configuration using the circular column 430, this configuration can be used to increase the length of the released suture 236 wrapped by the male and female column 430c per rotation of the suture tensioner 402.

[0252] FIG. 14A to FIG. 14B A third exemplary suture lock assembly 400c is shown, which includes a suture tensioner 402a in combination with the fourth exemplary quick release suture mechanism 302. FIG. 14A to FIG. 14B In the example of FIG. 4 , the suture lock assembly 400c is configured such that the tensioner housing 450c extends adjacent to a portion of the delivery device 200a. In particular, FIG. 14A to FIG. 14B An example is shown in which the tensioner housing 450c extends adjacent to and / or is a component of the hub assembly 218a of the delivery device 200a, which at least partially encloses the cannula shaft 220a and the pusher shaft 212a. Similar to the hub assembly 218 discussed above, the hub assembly 218a (along with the suture lock assembly 400c) can be used to independently control the pusher shaft 212a and the cannula shaft 220a, while the cannula handle 224a can control the axial position of the cannula shaft 220 relative to the pusher shaft 212.

[0253] like FIG. 14A to FIG. 15C and FIG. 15E to FIG. 15H As shown, the suture lock assembly 400 may include a rotator 410 that is configured to be manually actuated by a user to rotate the suture tensioner 402 relative to the tensioner housing 450. In some examples, and as shown in FIG. Fig.14A and FIG. 15E to FIG. 15H As shown, the rotator 410 is fixedly coupled to each of the posts 430 and / or is integrally formed with the posts 430. Similarly, in some examples, the rotator 410 may be fixedly coupled to the connector 420 and / or may include and / or define the connector 420. In particular, in FIG. 15E to FIG. 15H In the example of FIG. 4 , the rotator 410d, the connecting body 420d and the column 430d are integrally formed as a unitary component, so that the rotator 410d extends to the outside of the tensioner housing 450d, and the connecting body 420d and the column 430d extend to the inside of the tensioner housing 450d. Figure 15G As shown, the connector 420d may also include a bottom plate opposite to the rotator 410d, which limits the release suture 236 from falling off the post 430d. In this way, the connector 420d may be described as being used to retain the release suture 236 within the tensioner housing 450d.

[0254] In some examples, one or more components of the suture tensioner 402 are configured to be non-removably coupled to the tensioner housing 450. In other words, at least a portion of the suture tensioner 402 can be configured to be coupled to (e.g., assembled with) the tensioner housing 450 in such a manner that the suture tensioner 402 cannot be removed from the tensioner housing 450 without damaging the suture tensioner 402 and / or the tensioner housing 450.

[0255] As a more specific example, Fig.14A One example is shown where the rotator 410c includes a plurality of locking tabs 418c configured to limit removal of the rotator 410c from the tensioner housing 450c.

[0256] As another example, FIG. 15E to FIG. 15GOne example is shown where the tensioner housing 450d includes a plurality of locking tabs 456d configured to limit removal of the rotator 410d from the tensioner housing 450d.

[0257] Thus, in such examples, the rotator 410, connector 420, and post 430 may be integrally formed (e.g., molded) as a unitary component that may be easily assembled to the tensioner housing 450 by inserting the unitary component into the tensioner housing 450 until a locking tab (e.g., locking tab 418c or locking tab 456d) engages and retains the rotator 410 and / or tensioner housing 450. After the rotator 410, connector 420, and / or post 430 are fully inserted into the tensioner housing 450 in this manner, the locking tab 418 and / or locking tab 456 may be used to limit and / or prevent disassembly of the stitch lock assembly 400.

[0258] In various examples, the rotator 410 can include one or more features to facilitate grasping the rotator 410 and / or rotating the suture tensioner 402 to a desired tensioner configuration. FIG. 15A to FIG. 15C and FIG. 15G to FIG. 15H In the example of , the rotator 410d includes a gripping portion 412d configured to facilitate gripping the rotator 410d to manually rotate the suture tensioner 402d relative to the tensioner housing 450d. FIG. 15A to FIG. 15C and FIG. 15G to FIG. 15H In the example of , the gripping portion 412d includes a plurality of circumferentially distributed recesses around the circumference of the rotator 410d. In other examples, the gripping portion 412 may additionally or alternatively include and / or may be any suitable gripping feature, examples of which include textured surfaces, indentations, protrusions, knobs, levers, handles, tabs, etc.

[0259] In some examples, the suture tensioner 402 and / or the tensioner housing 450 may include one or more features for providing an indication of the rotational position of the rotator 410 relative to the tensioner housing 450. For example, Fig. 14B An example is shown in which the stitch lock assembly 400c includes an indicator 416c configured to provide a visual indication of the tensioner configuration. Fig. 14BIn the example of 416, each of the rotator 410c and the tensioner housing 450c includes a portion of the indicator 416c. Specifically, in this example, the indicator 416c includes a marking on the tensioner housing 450c and a pair of circumferentially spaced markings on the rotator 410c. Therefore, when the suture tensioner 402 is in a released configuration or a fully tensioned configuration, each marking on the rotator 410c can be aligned with a marking on the tensioner housing 450c. In other examples, the indicator 416 may include and / or may be any additional or alternative visual indicator, examples of which include markings, printed markings, embossed markings, recessed markings, digital scales, etc.

[0260] Additionally or alternatively, in some examples, the stitch lock assembly 300 and / or the stitch lock assembly 400 includes one or more features to selectively restrict access to the quick release suture mechanism 302. In particular, and as Fig. 14B As shown in dashed lines in , the suture lock assembly 400c can include a safety handle 414c that is operatively coupled to the rotator 410c and extends away from the rotator 410c. Specifically, when the rotator 410c is in a predetermined rotational orientation relative to the tensioner housing 450c (such as a fully tensioned configuration), the safety handle 414c can cover the quick release suture mechanism 302d to hinder and / or prevent manual access to the quick release suture mechanism 302d.

[0261] In particular, it may be desirable to ensure that the quick release suture mechanism 302 remains in a locked configuration while the suture tensioner 402 is in a fully tensioned configuration. Fig. 14B The safety handle 414c of the quick release docking port 304 can reduce the possibility of accidentally removing the suture anchoring cap 320 from the quick release docking port 304 before releasing the tension in the release suture 236. In such examples, rotating the rotator 410 to transition the suture tensioner 402 toward and / or to the release configuration (such as by grasping and rotating the safety handle 414) can be used to move the safety handle 414 away from the quick release suture mechanism 302, thereby allowing access to the suture anchoring cap 320.

[0262] In some examples, the stitch lock assembly 400 may include one or more features to limit and / or prevent unintentional rotation of the rotator 410 relative to the tensioner chamber 422. For example, the stitch lock assembly 400 may include a direction selector (such as a FIG. 6B to FIG. 6CThe direction selector 274 of the embodiment of the present invention can be used to allow the rotator 410 to rotate in only one direction to prevent rotation in an incorrect direction. In some examples, the direction selector can include a ratchet mechanism, such as a switchable ratchet mechanism that allows the user to select the desired rotation direction. In particular, the direction selector can allow the user to switch such a switchable ratchet mechanism between a first mode and a second mode, in which the rotator 410 can be rotated to increase the tension in the release suture 236 and is prevented from rotating to reduce the tension in the release suture 236, and in which the rotator 410 can be rotated to reduce the tension in the release suture 236. In some such examples, when in the second mode, the rotator is prevented from rotating to increase the tension in the release suture 236.

[0263] As another example (see FIG. 15F to FIG. 15G ), the stitch lock assembly 400d may include a rotator lock mechanism 490d configured to limit rotation of the rotator 410d away from one or more predetermined configurations (e.g., a fully tensioned configuration). In particular, in this example, the rotator 410d includes a rotator lock channel 424d accessible from below the rotator 410d, and the rotator receiver 482d includes a rotator lock protrusion 428d extending into the rotator lock channel 424d. To illustrate this configuration, Fig.15F 4 is a cross-sectional view of the stitch lock assembly 400 through a plane that intersects the rotator 410d at the top of the rotator lock channel 424d. The rotator lock mechanism 490d can be described as including a rotator lock channel 424d and a rotator lock protrusion 428d.

[0264] refer to Fig.15F Rotating the rotator 410d relative to the tensioner housing 482d is used to move the rotator lock channel 424d relative to the rotator lock protrusion 428d, thereby repositioning the rotator lock protrusion 428d within the rotator lock channel 424d. The rotator 410d may further include a pawl 426d that is used to increase the radius of the rotator lock channel 424d (e.g., relative to the tensioner center axis 404d) to partially limit the rotation of the rotator 410d relative to the tensioner housing 482d. For example, rotating the rotator 410d to a position where the rotator lock protrusion 428d engages the pawl 426d may limit further rotation of the rotator 410d in the same direction unless sufficient torque is applied to the rotator 410d to deflect the rotator lock protrusion 428d away from the tensioner center axis 404d and / or to deflect the pawl 426d toward the tensioner center axis 404d.

[0265] In addition, and if Fig.15FAs shown, the rotator lock channel 424d can include a lock projection receiver 425d, wherein when the rotator 410d is rotated to a position corresponding to the fully tensioned configuration, the rotator lock projection 428d can be received in the lock projection receiver. The lock projection receiver 425 can be partially defined by a pawl 426d, so that when the suture tensioner 402d is in the fully tensioned configuration, the rotator 410d is restricted from rotating to release the tension in the release suture unless sufficient torque is applied to the rotator 410d to move the pawl 426d past the rotator lock projection 428d.

[0266] exist Fig.15F In the example of the embodiment of the present invention, the rotator lock mechanism 490d includes a single pawl 426d, which partially defines a single corresponding lock protrusion receiver 425d, which in turn corresponds to a single predetermined configuration (e.g., a fully tensioned configuration) of the suture lock assembly 400d. In other examples, the rotator lock mechanism 490d can be used to define multiple such predetermined configurations, such as a release configuration or a partially tensioned configuration that can correspond to the suture lock assembly 400d. For example, such a rotator lock mechanism 490d can include multiple pawls 426d and / or multiple lock protrusion receivers 425d.

[0267] The rotator lock mechanism 490d may additionally or alternatively include any of a variety of other components or mechanisms for defining one or more predetermined configurations of the stitch lock assembly 400d. For example, the rotator lock projection 428 may be biased radially inward or radially outward and may be configured to be received in a groove, notch, etc. extending radially inward or radially outward from the rotator lock channel 424d when the rotator 410d is rotated to a position corresponding to the predetermined configuration of the stitch lock assembly 400d.

[0268] In some examples, and as Fig.11 and FIG. 15D to FIG. 15G As shown, the suture lock assembly 400 further includes one or more suture centralizers 458 configured to guide the release suture 236 through the tensioner housing 450. For example, when present, each suture centralizer can be configured to engage the tensioner housing 450 (e.g., within the suture entry port 452 or within the suture exit port 454) and support the release suture 236 passing through its central hole to maintain at least a portion of the release suture 236 away from the inner surface of the tensioner housing 450.

[0269] like Fig.11 and FIG. 14A to FIG. 15GAs further shown, the suture lock assembly 400 can additionally include a flushing port 460 that is fluidly coupled to the suture entry port 452 for supplying flushing fluid into the tensioner housing 450 and / or to a downstream portion of the delivery device 200. Specifically, the flushing port 460 can be fluidly coupled to the suture entry port 452 via the tensioner chamber 422. In some such examples, the tensioner housing 450 at least partially defines the flushing port 460. FIG. 15A to FIG. 15G In the example of FIG. 1 , the quick release suture mechanism 302e enables the release suture 236 to be removed from the implantable device without having to remove the suture from the delivery device connector 306 ( Fig.11 ) removes the suture lock assembly 400d so that irrigation fluid can be delivered to the delivery device 200 via the tensioner housing 450 without losing hemostasis.

[0270] When present, flush port 460 may include and / or may be any suitable port and / or coupling, such as a port that is nominally sealed and open when another component (e.g., a flushing fluid source) is operatively coupled to flush port 460. In some examples, flush port 460 may include and / or may be a Luer lock port and / or an exchangeable Luer lock port.

[0271] As discussed above, FIG. 15A to FIG. 15M The stitch lock assembly 400d of FIG. 4 represents an example in which the stitch lock assembly includes an example of a quick release stitch mechanism 302 (i.e., quick release stitch mechanism 302e). FIG. 15A to FIG. 15M In the example of FIG. 4 , the suture tensioner 402d and the quick release suture mechanism 302e are coupled to each other via a suture lock assembly housing 470d.

[0272] like Fig.15D As shown, the suture lock assembly housing 470d includes a first conduit 484d and a second conduit 486d branching from the first conduit 484d. Specifically, the first conduit can extend completely through the suture lock assembly housing 470d and can be configured to receive a component of a delivery device, such as the cannula shaft 220 of the delivery device 200. The second conduit 486d leads to the suture tensioner 402d, so that the release suture 236 extends to the suture tensioner 402d via the second conduit 486d. In this way, the first conduit 484d and the second conduit 486d can be similar to Figure 6B The straight section 242 and the branch 244 of the adapter 240 are shown.

[0273] exist FIG. 15A to FIG. 15MIn the example of , the stitch lock assembly housing 407d includes an inner housing 480d and an outer housing 472d, which at least substantially encloses the inner housing 480d. More specifically, in this example, the outer housing 472d may include an upper outer housing portion 474d and a lower outer housing portion 476d, which are configured to be assembled with each other on opposite sides of the inner housing 480d to at least substantially enclose the inner housing 480d.

[0274] exist FIG. 15A to FIG. 15M In the example of FIG. 4 , the inner housing 480d includes and / or defines each of the first conduit 484d and the second conduit 486d, and a rotator receiver 482d that receives at least a portion of the suture tensioner 402d. Specifically, as FIG. 15E to FIG. 15G As shown, the rotator receiver 482d defines a locking tab 456d.

[0275] In some examples, a seal may be included within the stitch lock assembly 400, such as by using one or more annular sealing elements (e.g., O-rings) 258, to prevent leakage of blood, saline, or other fluids through the system. Fig.14A and Fig.15E As shown, the stitch lock assembly 400c / 400d may include an O-ring 258c / 258d configured to form a seal between the rotator 410c / 410d and the tensioner housing 450c / 450d. Additionally or alternatively, the stitch lock assembly 300 / 400 may include one or more O-rings 258 configured to seal the release suture path when the stitch lock assembly 300 / 400 is assembled, thereby allowing hemostasis when connected to a properly sealed delivery device.

[0276] Any of the systems, devices, equipment, etc. herein may have been sterilized (e.g., using heating / heat, pressure, steam, radiation, and / or chemicals, etc.) to ensure that they are safe for use by patients, and any of the methods herein may include sterilization of the associated systems, devices, equipment, etc. as a step in the steps of the method. Examples of heating / thermal sterilization include steam sterilization and autoclave sterilization. Examples of radiation for sterilization include, but are not limited to, gamma radiation, ultraviolet radiation, and electron beams. Examples of chemicals for sterilization include, but are not limited to, ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde, and glutaraldehyde. Sterilization with hydrogen peroxide can be accomplished using, for example, hydrogen peroxide plasma.

[0277] Additional Embodiments of the Disclosed Technology

[0278] In view of the above-mentioned embodiments of the disclosed subject matter, the present application discloses the additional embodiments listed below. It should be noted that a feature of a separate embodiment or more than one feature of an embodiment adopted in combination, and optionally combined with one or more features of one or more further embodiments, is a further embodiment that also falls within the disclosure of the present application.

[0279] Embodiment 1. A quick-release suture mechanism, comprising: a suture anchoring cap, wherein the suture anchoring cap is configured to selectively connect to and disconnect from the quick-release docking port; wherein the quick-release suture mechanism is configured to connect to a suture, and the suture is configured to be connected to an implantable device, wherein the quick-release suture mechanism is configured to selectively switch between a locked configuration and an unlocked configuration, in which the quick-release suture mechanism holds the suture in a fixed position relative to the suture exit port, and in which the suture can be removed from the quick-release docking port in the unlocked configuration, wherein when the suture anchoring cap is operably connected to the quick-release docking port, the quick-release suture mechanism is in the locked configuration, and wherein when the suture anchoring cap is removed from the quick-release docking port, the quick-release suture mechanism is in the unlocked configuration.

[0280] Example 2. A quick-release suture mechanism according to any of the examples herein, in particular Example 1, wherein the quick-release suture mechanism is configured to be connected to a suture lock assembly including a tensioner housing, wherein the quick-release suture mechanism includes the quick-release docking port, and wherein the quick-release docking port is configured to be attached to a suture exit port of the tensioner housing.

[0281] Example 3. A quick-release suture mechanism according to any of the embodiments herein, in particular Example 2, wherein the quick-release suture mechanism is configured such that during operational use of the quick-release suture mechanism, the suture extends from the quick-release docking port through the suture exit port and continues through the suture entry port of the suture lock assembly to the implantable device, and returns to the quick-release docking port via the suture entry port and the suture exit port.

[0282] Example 4. According to any embodiment of the present invention, in particular, the quick-release suture mechanism of any one of Examples 1 to 3, wherein the quick-release suture mechanism is configured to be connected to the suture lock assembly, the suture lock assembly includes a tensioner housing and a reel configured to engage the suture, wherein the tensioner housing at least partially receives the reel, and wherein the reel is configured so that when the quick-release suture mechanism is in the locked configuration, the reel is rotated relative to the tensioner housing to wind a portion of the suture around the reel to increase the tension of the suture between the suture lock assembly and the implantable device.

[0283] Example 5. According to any embodiment of the present invention, in particular the quick-release suture mechanism described in any one of Examples 1 to 4, it also includes: the quick-release docking port; and a docking port connecting mechanism, wherein the docking port connecting mechanism is configured to selectively connect the suture anchoring cap to the quick-release docking port; wherein one or both of the suture anchoring cap and the quick-release docking port include at least a portion of the docking port connecting mechanism.

[0284] Example 6. A quick-release suture mechanism according to any of the embodiments herein, in particular Example 5, wherein the docking port connection mechanism includes a port thread of the quick-release docking port and a cap thread of the suture anchoring cap, and wherein the cap thread is configured to threadably engage the port thread to selectively connect the suture anchoring cap to the quick-release docking port.

[0285] Example 7. A quick release suture mechanism according to any embodiment of the present invention, in particular any one of embodiments 5 to 6, wherein the docking port connection mechanism includes a bayonet pin and a bayonet slot, the bayonet pin and the bayonet slot being configured to receive the bayonet pin when in a bayonet lock configuration, wherein one of the quick release docking port and the suture anchoring cap includes the bayonet pin, and wherein the other of the quick release docking port and the suture anchoring cap includes the bayonet slot.

[0286] Example 8. A quick-release suture mechanism according to any of the embodiments herein, in particular Example 7, wherein the bayonet pin includes and terminates in a pin cap having a diameter wider than the rest of the bayonet pin, wherein the suture extends between the suture anchoring end and the suture free end and terminates at each of the suture anchoring end and the suture free end, and wherein the quick-release suture mechanism is configured such that the suture free end can be wrapped around the bayonet pin so that the pin cap holds the suture on the bayonet pin.

[0287] Example 9. A quick-release suture mechanism according to any of the embodiments herein, in particular any of Examples 7 to 8, wherein the bayonet pin includes a transverse pin hole extending through the diameter of the bayonet pin, and wherein the quick-release suture mechanism is configured such that the suture can extend through the transverse pin hole to at least partially hold the suture relative to the bayonet pin.

[0288] Example 10. According to any embodiment of the present invention, in particular, the quick-release suture mechanism of any one of Examples 1 to 9, the suture anchoring cap comprises: an inner plug; an outer skirt, which circumferentially surrounds the inner plug; and an annular channel, which is defined between the outer skirt and the inner plug, and wherein, when the quick-release suture mechanism is in the locked configuration, the annular channel receives at least a portion of the quick-release docking port so that the inner plug is received in the quick-release docking port, and the outer skirt extends circumferentially around the quick-release docking port.

[0289] Example 11. A quick-release suture mechanism according to any embodiment of the present invention, in particular any one of embodiments 1 to 10, wherein the suture extends between a suture anchoring end and a suture free end and terminates at each of the suture anchoring end and the suture free end, wherein the suture anchoring cap includes a suture anchoring position, and wherein the suture anchoring cap is configured to be operatively connected to the suture anchoring end at the suture anchoring position so that during operational use of the quick-release suture mechanism, the suture anchoring end is restricted from being removed from the suture anchoring cap.

[0290] Embodiment 12. According to any embodiment of the present invention, in particular the quick-release suture mechanism described in embodiment 11, the suture anchoring end is configured to be fixedly connected to the suture anchoring position.

[0291] Example 13. A quick-release suture mechanism according to any embodiment herein, in particular any one of Examples 11 to 12, wherein the suture anchoring end is configured to be operably connected to the suture anchoring position via one or more of an adhesive, a cement, a mechanical connector, a tie connector, and a mechanical embolization.

[0292] Example 14. According to any embodiment of the present invention, in particular, the quick-release suture mechanism described in any one of Examples 11 to 13, the quick-release suture mechanism is configured such that: when the quick-release suture mechanism is in the locked configuration, the free end of the suture is at least substantially fixed in an appropriate position relative to the quick-release docking port, and when the quick-release suture mechanism is in the unlocked configuration, the free end of the suture is free to move through the quick-release docking port.

[0293] Example 15. According to any embodiment of the present invention, in particular, the quick-release suture mechanism described in any one of Examples 11 to 14, it also includes a docking port connecting mechanism, which is configured to selectively connect the suture anchoring cap to the quick-release docking port, wherein the docking port connecting mechanism includes a port thread of the quick-release docking port and a cap thread of the suture anchoring cap, wherein the cap thread is configured to threadably engage the port thread to selectively connect the suture anchoring cap to the quick-release docking port, and wherein the quick-release suture mechanism is configured so that when the quick-release suture mechanism is in the locking configuration, the free end of the suture extends between the port thread and the cap thread and is locked in an appropriate position by the port thread and the cap thread.

[0294] Embodiment 16. A quick-release suture mechanism according to any embodiment herein, in particular any one of embodiments 11 to 15, wherein the suture anchoring cap defines an inner hole, and wherein one or both of the suture anchoring end and the suture free end at least partially extends through the inner hole.

[0295] Embodiment 17. According to any embodiment of the present invention, in particular the quick-release suture mechanism described in Embodiment 16, wherein the inner hole includes the suture anchoring position.

[0296] Embodiment 18. According to any embodiment herein, in particular any one of embodiments 16 to 17, the quick-release suture mechanism, wherein the suture anchoring cap comprises an inner plug defining at least a portion of the inner hole.

[0297] Example 19. A quick-release suture mechanism according to any embodiment herein, in particular any one of Examples 16 to 18, wherein the inner hole is a first inner hole, wherein the suture anchoring cap further comprises a second inner hole, wherein the suture anchoring end at least partially extends through the first inner hole, and wherein when the quick-release suture mechanism is in the locking configuration, the free end of the suture extends at least partially through the second inner hole.

[0298] Embodiment 20. A quick-release suture mechanism according to any embodiment herein, in particular any one of embodiments 11 to 19, wherein the inner hole extends completely through the length of the suture anchoring cap.

[0299] Embodiment 21. A quick-release suture mechanism according to any embodiment herein, in particular any one of embodiments 11 to 19, wherein the inner hole extends through only a portion of the length of the suture anchoring cap.

[0300] Example 22. According to any embodiment of the present invention, in particular any one of embodiments 11 to 21, the quick-release suture mechanism is configured so that when the quick-release suture mechanism is in the locking configuration, the free end of the suture extends at least substantially to the outside of the inner hole.

[0301] Example 23. A quick release suture mechanism according to any embodiment of the present invention, in particular any one of embodiments 11 to 22, wherein the quick release docking port is configured to be attached to a suture exit port of a tensioner housing, wherein the suture anchoring cap comprises: an inner plug; an outer skirt, the outer skirt circumferentially surrounding the inner plug; and an annular channel, the annular channel being defined between the outer skirt and the inner plug; wherein, when the quick release suture mechanism is in the locked configuration, the annular channel receives at least a portion of the quick release docking port so that the inner plug is received in the quick release docking port, and the outer skirt extends circumferentially around the quick release docking port, and wherein the quick release suture mechanism is configured such that when the quick release suture mechanism is in the locked configuration, the free end of the suture extends from the suture exit port through the inner hole, around the outer skirt into the annular channel, and again extends through the inner hole.

[0302] Example 24. According to any embodiment of the present invention, in particular, the quick-release suture mechanism of any one of Examples 1 to 23, the suture anchoring cap includes a gripping feature, and the gripping feature is configured to facilitate gripping of the suture anchoring cap so that the quick-release suture mechanism can be converted between the locked configuration and the unlocked configuration.

[0303] Embodiment 25. According to any embodiment of the present invention, in particular the quick release suture mechanism described in embodiment 24, wherein the gripping feature includes one or more of a textured surface, a dimple, a protrusion, a knob, a lever, a handle, and a tab.

[0304] Example 26. According to any embodiment of the present invention, in particular any one of embodiments 1 to 25, the quick-release suture mechanism further includes a gasket configured to form an at least substantially fluid-tight seal to limit leakage from the quick-release docking port.

[0305] Example 27. A quick-release suture mechanism according to any of the embodiments herein, in particular Example 26, wherein the quick-release suture mechanism is configured to be connected to a suture lock assembly including a tensioner housing, and wherein the gasket is configured to form an at least substantially fluid-tight seal between the suture anchor cap and the tensioner housing when the quick-release suture mechanism is in the locked configuration.

[0306] Example 28. A quick release suture mechanism according to any embodiment herein, in particular any one of Examples 26 to 27, wherein the gasket is configured to form a seal that is at least substantially fluid-tight to limit the flow of fluid out of the quick release docking port when the quick release suture mechanism is in the unlocked configuration.

[0307] Example 29. A quick release suture mechanism according to any embodiment herein, in particular any one of Examples 26 to 28, wherein the quick release docking port is configured to be attached to a suture exit port of a tensioner housing, and wherein the gasket is received within one or both of the suture exit port and the quick release docking port.

[0308] Example 30. A quick release suture mechanism according to any embodiment herein, in particular any one of embodiments 26 to 29, wherein the quick release docking port is configured to be attached to a suture exit port of a tensioner housing, and wherein the gasket is a suture centralizer, which is used to maintain the suture in the center area of ​​the suture exit port to align the suture with the inner hole of the suture anchoring cap.

[0309] Example 31. According to any embodiment of the present invention, in particular, the quick-release suture mechanism described in any one of Examples 26 to 30, it also includes a docking port connecting mechanism, which is configured to selectively connect the suture anchoring cap to the quick-release docking port, wherein the docking port connecting mechanism includes a bayonet pin and a bayonet slot, and the bayonet slot is configured to receive the bayonet pin when in a bayonet lock configuration, wherein one of the quick-release docking port and the suture anchoring cap includes the bayonet pin, wherein the other of the quick-release docking port and the suture anchoring cap includes the bayonet slot, and wherein, when the quick-release suture mechanism is in the locking configuration, the washer pushes the suture anchoring cap radially outward to push the bayonet pin to engage with the bayonet slot.

[0310] Embodiment 32. A suture lock assembly comprising: a reel configured to engage a suture configured to be connected to an implantable device; and a quick release suture mechanism; wherein the quick release suture mechanism is a quick release suture mechanism according to any one of embodiments 1 to 31.

[0311] Example 33. According to any embodiment of the present invention, in particular the suture lock assembly described in Example 32, it also includes a tensioner housing that at least partially receives the reel, wherein the tensioner housing includes a suture entry port and a suture exit port, and wherein the quick release suture mechanism is attached to the suture exit port.

[0312] Embodiment 34. According to any embodiment of the present invention, in particular the stitch lock assembly described in Embodiment 33, wherein the tensioner housing includes the quick release docking port.

[0313] Embodiment 35. According to any embodiment of the present invention, in particular any one of embodiments 33 to 34, the suture lock assembly, wherein the quick release docking port and the suture exit port are formed integrally.

[0314] Embodiment 36. According to any embodiment of the present invention, in particular any one of embodiments 33 to 35, the suture lock assembly is configured so that the suture extends between the implantable device and the reel through the suture access port.

[0315] Embodiment 37. According to any embodiment of the present invention, in particular any one of embodiments 33 to 36, the suture lock assembly is configured so that the suture extends between the reel and the quick release suture mechanism via the suture exit port.

[0316] Example 38. A suture lock assembly according to any of the embodiments herein, in particular any of Examples 32 to 37, wherein the suture lock assembly is configured to be operably connected to a delivery device, the delivery device is configured to deliver the implantable device to a target implantation site in a patient's body, and wherein the tensioner housing is configured to be operably connected to a delivery device connector of the delivery device, so that the suture extends between the reel and the implantable device via the delivery device connector.

[0317] Example 39. According to any embodiment of the present invention, in particular, the suture lock assembly described in Example 38, it also includes a tensioner housing that at least partially receives the reel, wherein the tensioner housing includes a suture entry port and a suture exit port, wherein the quick release suture mechanism is attached to the suture exit port, and wherein the suture entry port is configured to be operably connected to the delivery device connector.

[0318] Example 40. According to any embodiment of the present invention, in particular any one of Examples 33 to 39, the suture lock assembly further includes one or more suture centralizers, wherein the one or more suture centralizers are configured to guide the suture through the tensioner housing.

[0319] Embodiment 41. According to any embodiment of the present invention, in particular the suture lock assembly described in embodiment 40, at least one suture centralizer is configured to maintain at least a portion of the suture away from the inner surface of the tensioner housing.

[0320] Embodiment 42. According to any embodiment of the present invention, in particular any one of embodiments 40 to 41, the suture lock assembly, wherein at least one suture centralizer engages the tensioner housing within the suture entry port.

[0321] Embodiment 43. According to any embodiment of the present invention, in particular any one of embodiments 40 to 42, the suture lock assembly, wherein at least one suture centralizer engages the tensioner housing within the suture exit port.

[0322] Embodiment 44. A suture lock assembly according to any embodiment herein, in particular any one of embodiments 33 to 43, wherein the reel is configured to selectively rotate relative to the tensioner housing to selectively increase the length of the suture enclosed by the tensioner housing.

[0323] Embodiment 45. According to any embodiment of the present invention, in particular any one of embodiments 33 to 44, the stitch lock assembly further includes a rotator configured to be manually actuated by a user to rotate the spool relative to the tensioner housing.

[0324] Embodiment 46. The stitch lock assembly according to any embodiment herein, in particular embodiment 45, wherein the rotator is fixedly coupled to the reel.

[0325] Embodiment 47. The stitch lock assembly according to any embodiment herein, in particular any one of embodiments 45 to 46, wherein at least a portion of the rotator extends outside the tensioner housing.

[0326] Embodiment 48. According to any embodiment of the present invention, in particular any one of embodiments 45 to 47, the suture lock assembly, wherein the rotator includes a gripping portion, and the gripping portion is configured to facilitate gripping the rotator to manually rotate the reel relative to the tensioner housing.

[0327] Embodiment 49. According to any embodiment of the present invention, in particular the stitch lock assembly described in embodiment 48, wherein the gripping portion includes one or more of a textured surface, a dimple, a protrusion, a knob, a lever, a handle, and a tab.

[0328] Example 50. According to any embodiment of the present invention, in particular, the suture lock assembly described in any one of Examples 45 to 49, it also includes a safety handle that is operably connected to the rotator and extends away from the rotator, wherein the safety handle covers the quick release suture mechanism to hinder access to the quick release suture mechanism when the rotator is in a predetermined rotational orientation relative to the tensioner housing.

[0329] Embodiment 51. According to any embodiment of the present invention, in particular the suture lock assembly described in embodiment 50, the predetermined rotational orientation corresponds to a configuration in which the reel is used to apply tension to the suture.

[0330] Example 52. A suture lock assembly according to any embodiment herein, in particular any one of Examples 50 to 51, wherein the suture lock assembly is configured such that rotating the rotator away from the predetermined rotational orientation moves the safety handle away from the quick release suture mechanism to allow access to the suture anchoring cap.

[0331] Embodiment 53. According to any embodiment of the present invention, in particular any one of embodiments 45 to 52, the suture lock assembly further includes a direction selector, which is configured to allow the rotator to rotate in only one direction to prevent rotation in an incorrect direction.

[0332] Embodiment 54. According to any embodiment of the present invention, in particular the stitch lock assembly described in Embodiment 53, wherein the direction selector includes a ratchet mechanism.

[0333] Example 55. A suture lock assembly according to any of the embodiments herein, in particular any of Examples 53 to 54, wherein the direction selector is configured to switch between a first mode and a second mode, wherein in the first mode, the rotator can be rotated to increase the tension in the suture and is prevented from rotating to reduce the tension in the suture, and in the second mode, the rotator can be rotated to reduce the tension in the suture and is prevented from rotating to increase the tension in the suture.

[0334] Embodiment 56. According to any embodiment of the present invention, in particular any one of embodiments 33 to 55, the suture lock assembly further includes a flushing port fluidly connected to the suture access port.

[0335] Embodiment 57. The stitch lock assembly according to any embodiment herein, in particular embodiment 56, wherein the tensioner housing at least partially defines the flushing port.

[0336] Embodiment 58. A delivery device for a prosthetic implant comprising a quick release suture mechanism according to any one of embodiments 1 to 31 or a suture lock assembly according to any one of embodiments 32 to 57.

[0337] Embodiment 59. A suture lock assembly comprising: a suture tensioner configured to engage a suture configured to be connected to an implantable device, wherein the suture tensioner is configured to selectively rotate about a tensioner central axis to collect a certain length of the suture; and wherein the suture tensioner comprises: a pair of spaced-apart columns, each column configured to rotate about the tensioner central axis as the suture tensioner rotates; and a connector connected to each of the columns.

[0338] Example 60. According to any embodiment of the present invention, in particular, the suture lock assembly described in Example 59, it also includes a tensioner housing that at least partially receives the suture tensioner, wherein the suture tensioner is configured to rotate relative to the tensioner housing, and wherein the tensioner housing includes a suture entry port so that the suture extends between the implantable device and the suture tensioner through the suture entry port.

[0339] Example 61. A suture lock assembly according to any of the embodiments herein, in particular Example 60, wherein the suture lock assembly is configured such that during operational use of the suture lock assembly, the suture extends from the suture tensioner through the suture access port to the implantable device and returns to the suture tensioner via the suture access port.

[0340] Example 62. A suture lock assembly according to any embodiment herein, in particular any one of Examples 59 to 61, wherein the suture tensioner is configured such that rotating the suture tensioner is used to wrap a portion of the suture around the pair of columns to increase the tension in the suture between the suture tensioner and the implantable device.

[0341] Embodiment 63. According to any embodiment of the present invention, in particular any one of embodiments 59 to 62, the stitch lock assembly is configured so that at least a portion of the suture is fixedly connected to one of the posts.

[0342] Example 64. A suture lock assembly according to any embodiment herein, in particular any one of Examples 59 to 63, wherein the suture extends between a first end and a second end and terminates at each of the first end and the second end, and wherein one or both of the first end and the second end are fixedly connected to a suture anchoring position of the suture tensioner.

[0343] Embodiment 65. According to any embodiment of the present invention, in particular the suture lock assembly described in embodiment 64, at least one of the posts includes the suture anchoring location.

[0344] Example 66. A suture lock assembly according to any of the embodiments herein, in particular any one of Examples 59 to 65, wherein the suture lock assembly is configured such that the suture tensioner can be rotated to a position wherein the post is spaced apart from the suture.

[0345] Example 67. A suture lock assembly according to any embodiment herein, in particular any one of Examples 60 to 66, wherein the tensioner housing further comprises a suture exit port, such that the suture extends through the tensioner housing between the suture entry port and the suture exit port.

[0346] Example 68. A suture lock assembly according to any of the embodiments herein, in particular any one of Examples 59 to 67, wherein the suture lock assembly comprises a rotator configured to be manually actuated by a user to rotate the suture tensioner.

[0347] Embodiment 69. The stitch lock assembly according to any embodiment herein, in particular embodiment 68, wherein the rotator is fixedly coupled to each of the posts.

[0348] Embodiment 70. According to any embodiment of the present invention, in particular any one of embodiments 68 to 69, the stitch lock assembly, wherein the rotator and the column are formed integrally.

[0349] Embodiment 71. The stitch lock assembly according to any embodiment herein, in particular any one of embodiments 68 to 70, wherein the rotator is fixedly coupled to the connector.

[0350] Embodiment 72. According to any embodiment of the present invention, in particular any one of embodiments 68 to 71, the stitch lock assembly, wherein the rotator includes the connector.

[0351] Embodiment 73. According to any embodiment of the present invention, in particular any one of embodiments 68 to 72, the suture lock assembly, wherein the rotator includes a gripping portion, and the gripping portion is configured to facilitate gripping the rotator to manually rotate the suture tensioner.

[0352] Embodiment 74. According to any embodiment of the present invention, in particular the suture lock assembly described in embodiment 73, the gripping portion includes one or more of a textured surface, a dimple, a protrusion, a knob, a lever, a handle, and a tab.

[0353] Example 75. According to any embodiment of the present invention, in particular any one of Examples 68 to 74, the suture lock assembly further includes a direction selector, which is configured to allow the rotator to rotate in only one direction to prevent rotation in an incorrect direction.

[0354] Embodiment 76. According to any embodiment of the present invention, in particular the suture lock assembly described in embodiment 75, wherein the direction selector includes a ratchet mechanism.

[0355] Example 77. A suture lock assembly according to any of the embodiments herein, in particular any of Examples 75 to 76, wherein the direction selector is configured to switch between a first mode and a second mode, wherein in the first mode, the rotator can be rotated to increase the tension in the suture and is prevented from rotating to reduce the tension in the suture, and in the second mode, the rotator can be rotated to reduce the tension in the suture and is prevented from rotating to increase the tension in the suture.

[0356] Example 78. The suture lock assembly according to any embodiment herein, in particular any one of Examples 68 to 77, further includes a tensioner housing that at least partially receives the suture tensioner, wherein the suture tensioner is configured to rotate relative to the tensioner housing, and wherein at least a portion of the rotator extends to the outside of the tensioner housing.

[0357] Example 79. The suture lock assembly according to any embodiment herein, in particular any one of Examples 68 to 78, further includes a tensioner housing that at least partially receives the suture tensioner, wherein the suture tensioner is configured to rotate relative to the tensioner housing, and wherein one or both of the tensioner housing and the rotator include one or more locking tabs, and the one or more locking tabs are configured to limit the removal of the rotator from the tensioner housing.

[0358] Example 80. A suture lock assembly according to any of the embodiments herein, in particular any of Examples 59 to 79, wherein the suture tensioner is configured to rotate so as to convert the suture tensioner between a plurality of tensioner configurations, the plurality of tensioner configurations being limited between and including a release configuration and a fully tensioned configuration, wherein in the release configuration the column is positioned to apply no force to the suture, and in the fully tensioned configuration the column is positioned to engage the suture to generate maximum tension in the suture when the suture is connected to the implantable device.

[0359] Example 81. A suture lock assembly according to any of the embodiments herein, in particular Example 80, wherein the suture tensioner is configured to rotate through one or more angles of less than 180 degrees, approximately 180 degrees, greater than 180 degrees, less than 360 degrees, approximately 360 degrees, and greater than 360 degrees to convert the suture tensioner between the released configuration and the fully tensioned configuration.

[0360] Example 82. According to any embodiment of the present invention, in particular any one of Examples 80 to 81, the suture lock assembly further includes one or more rotator stops, which are configured to engage a portion of the suture lock assembly to mechanically limit the rotation of the suture tensioner, thereby limiting one or both of the released configuration and the fully tensioned configuration.

[0361] Example 83. According to any embodiment of the present invention, in particular, the suture lock assembly described in Example 82, it also includes a tensioner housing that at least partially receives the suture tensioner, wherein the suture tensioner is configured to rotate relative to the tensioner housing, and wherein the one or more rotator stops are fixed in an appropriate position relative to the tensioner housing.

[0362] Example 84. According to any of the embodiments herein, in particular Example 83, the suture lock assembly further includes a rotator configured to be manually actuated by a user to rotate the suture tensioner relative to the tensioner housing, and wherein at least one of the one or more rotator stops is configured to engage the rotator to limit one or both of the released configuration and the fully tensioned configuration.

[0363] Example 85. A suture lock assembly according to any embodiment herein, in particular any one of embodiments 82 to 84, wherein at least one of the one or more rotator stops is configured to engage at least one of the pair of spaced-apart columns to limit one or both of the released configuration and the fully tensioned configuration.

[0364] Embodiment 86. According to any embodiment herein, in particular any one of embodiments 80 to 85, the stitch lock assembly further comprises an indicator configured to provide a visual indication of the tensioner configuration.

[0365] Example 87. The suture lock assembly according to any of the embodiments herein, in particular Example 86, further includes: a tensioner housing, which at least partially accommodates the suture tensioner; and a rotator, which is configured to be manually actuated by a user to rotate the suture tensioner relative to the tensioner housing, and wherein one or both of the rotator and the tensioner housing include at least a portion of the indicator.

[0366] Embodiment 88. According to any embodiment of the present invention, in particular any one of embodiments 86 to 87, the suture lock assembly, wherein the indicator is configured to provide an indication that the suture tensioner is in one or more of the released configuration and the fully tensioned configuration.

[0367] Example 89. A suture lock assembly according to any of the embodiments herein, in particular any one of Examples 86 to 88, wherein the indicator comprises one or more of a mark, a printed mark, an embossed mark, a recessed mark, a digital scale, and a pair of visual indicators, and the indicators are aligned when the suture tensioner is in one or more of the released configuration and the fully tensioned configuration.

[0368] Example 90. According to any embodiment of the present invention, in particular, the suture lock assembly of any one of Examples 80 to 89, it also includes a tensioner housing that at least partially receives the suture tensioner, wherein the suture tensioner is configured to rotate relative to the tensioner housing, wherein the tensioner housing includes a suture entry port so that the suture extends between the implantable device and the suture tensioner via the suture entry port, wherein the tensioner housing also includes a suture exit port so that the suture extends through the tensioner housing between the suture entry port and the suture exit port, and wherein, when the suture tensioner is in the release configuration, one or more of the columns are spaced apart from a straight line connecting the suture entry port and the suture exit port.

[0369] Example 91. According to any embodiment of the present invention, in particular, the suture lock assembly of any one of Examples 80 to 90, it also includes a tensioner housing that at least partially receives the suture tensioner, wherein the suture tensioner is configured to rotate relative to the tensioner housing, wherein the tensioner housing includes a suture entry port so that the suture extends between the implantable device and the suture tensioner via the suture entry port, wherein the tensioner housing also includes a suture exit port so that the suture extends through the tensioner housing between the suture entry port and the suture exit port, and wherein, when the suture tensioner is in the release configuration, one or both of the columns are tangent to the straight line connecting the suture entry port and the suture exit port.

[0370] Example 92. The suture lock assembly according to any embodiment herein, in particular any one of Examples 80 to 91, further comprising a tensioner housing that at least partially receives the suture tensioner, wherein the suture tensioner is configured to rotate relative to the tensioner housing, wherein the tensioner housing comprises a tensioner chamber that encloses at least a portion of the columns and a portion of the suture, and wherein, when the suture tensioner is in the released configuration, the suture freely occupies the area of ​​the tensioner chamber between the columns without being obstructed by a portion of the suture tensioner.

[0371] Example 93. According to any embodiment of the present invention, in particular any one of Examples 59 to 92, the suture lock assembly further includes: a rotator configured to be manually actuated by a user to rotate the suture tensioner; and a rotator lock mechanism configured to limit the rotator from rotating away from one or more predetermined configurations.

[0372] Example 94. A suture lock assembly according to any of the embodiments herein, in particular Example 93, wherein the suture tensioner is configured to rotate so as to convert the suture tensioner between a plurality of tensioner configurations, the plurality of tensioner configurations being limited between and including a release configuration and a fully tensioned configuration, wherein in the release configuration, the column is positioned to apply no force to the suture, and in the fully tensioned configuration, the column is positioned to engage the suture to generate maximum tension in the suture when the suture is connected to the implantable device, and wherein the rotator lock mechanism is configured to limit the rotator from rotating away from the fully tensioned configuration.

[0373] Example 95. According to any embodiment of the present invention, in particular any one of Examples 93 to 94, the suture lock assembly further includes a tensioner housing that at least partially receives the suture tensioner, wherein the rotator includes a rotator lock channel, wherein the tensioner housing includes a rotator lock protrusion extending into the rotator lock channel, and wherein the rotator lock mechanism includes the rotator lock channel and the rotator lock protrusion.

[0374] Example 96. The suture lock assembly according to any of the examples herein, in particular Example 95, wherein rotating the rotator relative to the tensioner housing is used to move the rotator lock channel relative to the rotator lock protrusion.

[0375] Example 97. A suture lock assembly according to any of the embodiments herein, in particular any one of Examples 95 to 96, wherein the rotator includes a pawl that increases the radius of the rotator lock channel to partially limit the rotation of the rotator relative to the tensioner housing.

[0376] Example 98. A suture lock assembly according to any of the embodiments herein, in particular Example 97, wherein the rotator lock channel includes a lock protrusion receiver, the rotator lock protrusion being received in the lock protrusion receiver when the rotator is rotated to a position corresponding to a fully tensioned configuration, and wherein the pawl partially defines the lock protrusion receiver.

[0377] Embodiment 99. According to any embodiment of the present invention, in particular any one of embodiments 59 to 98, the suture lock assembly, wherein each post has one or more shapes selected from the group consisting of cylindrical, conical, and frustoconical.

[0378] Embodiment 100. According to any embodiment of the present invention, in particular any one of embodiments 59 to 99, the stitch lock assembly, wherein each column has one or more cross-sectional shapes of curved, circular, oval, elliptical and hermaphroditic.

[0379] Embodiment 101. According to any embodiment of the present invention, in particular any one of embodiments 59 to 100, the stitch lock assembly, wherein the pair of posts are at least substantially identical to each other.

[0380] Embodiment 102. A suture lock assembly according to any embodiment herein, in particular any one of embodiments 59 to 101, wherein each post comprises a suture engaging surface that engages the suture during operational use of the suture lock assembly.

[0381] Embodiment 103. According to any embodiment of the present invention, in particular embodiment 102, the suture lock assembly is configured so that as the suture tensioner rotates, the suture slides relative to each suture engagement surface.

[0382] Embodiment 104. A suture lock assembly according to any embodiment herein, in particular any one of embodiments 102 to 103, wherein the suture tensioner is configured to maintain the suture in static contact with each suture engagement surface as the suture tensioner rotates.

[0383] Example 105. A suture lock assembly according to any embodiment herein, in particular any one of Examples 102 to 104, wherein the suture tensioner comprises a pair of rollers, each roller rotatably connected to a corresponding column, wherein each roller comprises a corresponding suture engagement surface, and wherein each roller is configured to rotate relative to the corresponding column to maintain the suture in static contact with the corresponding suture engagement surface as the suture tensioner rotates.

[0384] Embodiment 106. A suture lock assembly according to any embodiment herein, in particular any one of embodiments 102 to 105, wherein each post comprises a leading edge and a trailing edge, and wherein the suture engaging surface extends between the leading edge and the trailing edge.

[0385] Example 107. A suture lock assembly according to any of the embodiments herein, in particular Example 106, wherein each column has a width as measured along a direction perpendicular to and intersecting the center axis of the tensioner, the width being greater at the leading edge of the column than at the trailing edge of the column.

[0386] Embodiment 108. The stitch lock assembly according to any embodiment herein, in particular any one of embodiments 59 to 107, wherein each post is rotatably coupled to the connector.

[0387] Example 109. A suture lock assembly according to any of the embodiments herein, in particular any of Examples 60 to 108, wherein the suture lock assembly is configured to be operably connected to a delivery device, the delivery device is configured to deliver the implantable device to a target implantation site in a patient's body, and wherein the tensioner housing is configured to be operably connected to a delivery device connector of the delivery device, so that the suture extends between the suture tensioner and the implantable device via the delivery device connector.

[0388] Embodiment 110. The suture lock assembly according to any embodiment herein, in particular embodiment 109, wherein the suture access port is configured to be operatively coupled to the delivery device connector.

[0389] Embodiment 111. According to any embodiment of the present invention, in particular any one of embodiments 60 to 110, the suture lock assembly further includes one or more suture centralizers configured to guide the suture through the tensioner housing.

[0390] Embodiment 112. The suture lock assembly according to any embodiment herein, in particular embodiment 111, wherein at least one suture centralizer is configured to maintain at least a portion of the suture away from the inner surface of the tensioner housing.

[0391] Embodiment 113. The suture lock assembly according to any embodiment herein, in particular any one of embodiments 111 to 112, wherein at least one suture centralizer engages the tensioner housing within the suture entry port.

[0392] Example 114. A suture lock assembly according to any embodiment herein, in particular any one of Examples 111 to 113, wherein the tensioner housing further comprises a suture exit port, such that the suture extends through the tensioner housing between the suture entry port and the suture exit port, and wherein at least one suture centralizer engages the tensioner housing within the suture exit port.

[0393] Embodiment 115. According to any embodiment of the present invention, in particular any one of embodiments 60 to 114, the suture lock assembly further includes a flushing port fluidly connected to the suture access port.

[0394] Embodiment 116. The stitch lock assembly according to any embodiment herein, in particular Embodiment 115, wherein the tensioner housing at least partially defines the flushing port.

[0395] Example 117. A suture lock assembly according to any of the embodiments herein, in particular any one of Examples 115 to 116, wherein the tensioner housing includes a tensioner chamber enclosing a portion of the suture, and wherein the flushing port is fluidly connected to the suture entry port via the tensioner chamber.

[0396] Example 118. A suture lock assembly according to any embodiment herein, in particular any one of Examples 60 to 117, wherein the tensioner housing further comprises a suture exit port, such that the suture extends through the tensioner housing between the suture entry port and the suture exit port, wherein the suture lock assembly further comprises a quick release suture mechanism connected to the suture exit port, and wherein the quick release suture mechanism is a quick release suture mechanism according to any one of Examples 1 to 31.

[0397] Embodiment 119. According to any embodiment of the present invention, in particular, the suture lock assembly described in Embodiment 118, it also includes a suture lock assembly housing, and the suture lock assembly housing operatively connects the suture tensioner and the quick release suture mechanism to each other.

[0398] Example 120. A suture lock assembly according to any of the embodiments herein, in particular Example 119, wherein the suture lock assembly housing comprises: a first catheter configured to receive a cannula shaft of a delivery device; and a second catheter branching from the first catheter; and wherein the suture extends to the suture tensioner via the second catheter.

[0399] Embodiment 121. According to any embodiment of the present invention, in particular any one of embodiments 119 to 120, the stitch lock assembly, wherein the stitch lock assembly housing comprises an inner housing and an outer housing, and the outer housing at least substantially encloses the inner housing.

[0400] Example 122. A suture lock assembly according to any embodiment herein, in particular Example 121, wherein the inner shell comprises: a first catheter, the first catheter being configured to receive a sleeve shaft of a delivery device; and a second catheter, the second catheter branching from the first catheter; and wherein the suture extends to the suture tensioner via the second catheter.

[0401] Embodiment 123. A stitch lock assembly according to any embodiment herein, in particular any one of Embodiments 121 to 122, wherein the outer shell comprises an upper outer shell portion and a lower outer shell portion, and the upper outer shell portion and the lower outer shell portion are configured to be assembled with each other on opposite sides of the inner shell to at least substantially enclose the inner shell.

[0402] Embodiment 124. According to any embodiment of the present invention, in particular any one of embodiments 121 to 123, the suture lock assembly, wherein the inner housing includes a rotator receiver, and the rotator receiver receives at least a portion of the suture tensioner.

[0403] Example 125. A suture lock assembly according to any embodiment herein, in particular any one of Examples 121 to 124, wherein the suture lock assembly includes a rotator configured to be manually actuated by a user to rotate the suture tensioner, and wherein the inner shell includes one or more locking tabs configured to limit removal of the rotator from the rotator receiver.

[0404] Embodiment 126. A quick-release suture mechanism according to any embodiment herein, in particular any one of embodiments 1 to 31, wherein the quick-release suture mechanism has been sterilized.

[0405] Embodiment 127. A method comprising: sterilizing the quick release suture mechanism according to any one of embodiments 1 to 31.

[0406] Embodiment 128. A quick release suture mechanism according to any embodiment herein, in particular any one of embodiments 32 to 57 and embodiments 69 to 125, wherein the suture lock assembly is sterilized.

[0407] Embodiment 129. A method comprising: sterilizing the stitch lock assembly according to any one of embodiments 32 to 57 and embodiments 59 to 125.

[0408] Embodiment 130. The device according to any embodiment herein, in particular embodiment 58, wherein the delivery device is sterilized.

[0409] Embodiment 131. A method comprising: sterilizing the delivery device according to Embodiment 130.

[0410] Unless otherwise stated, the features described herein with respect to any embodiment may be combined with other features described in any one or more embodiments of the other embodiments. For example, any one or more features of a quick-release suture mechanism may be combined with any one or more features of another quick-release suture mechanism. As another example, any one or more features of a suture lock assembly may be combined with any one or more features of another suture lock assembly and / or with any one or more features of a quick-release suture mechanism. In addition, any one or more features of a delivery device may be combined with any one or more features of another delivery device, with one or more features of a suture lock assembly, and / or with one or more features of a quick-release suture mechanism.

[0411] In view of the many possible ways in which the principles of the present disclosure can be applied, it should be recognized that the illustrated configurations depict embodiments of the disclosed technology and should not be considered to limit the scope of the present disclosure, nor should they be considered to limit the claims. Rather, the scope of the claimed subject matter is defined by the following claims and their equivalents.

Claims

1. A delivery device for a prosthetic implant, characterized in that include: handle assembly; one or more shafts coupled to the handle assembly, wherein the one or more shafts include a delivery shaft configured to be advanced through a patient's vasculature to an implantation site and configured to retain an implantable device; a pusher assembly configured to deploy and / or implant the implantable device at an implantation site; a suture configured to couple an implantable device to the delivery apparatus; as well as A suture lock assembly, the suture lock assembly comprising: a suture tensioner configured to engage the suture, the suture tensioner comprising: a pair of spaced-apart posts, each post configured to rotate about a tensioner central axis as the suture tensioner rotates; The suture tensioner is configured to selectively rotate about the tensioner central axis to collect a certain length of the suture.

2. The delivery device according to claim 1, characterized in that The implantable device includes a docking device.

3. The delivery device according to claim 1, characterized in that The suture can be cut to remove the implantable device from the delivery apparatus.

4. The delivery device according to claim 1, characterized in that The suture tensioner is configured to selectively increase or decrease the tension of the suture.

5. The delivery device according to claim 2, characterized in that The handle assembly includes a handle that includes one or more knobs, buttons, wheels, and / or devices for controlling or actuating one or more components of the delivery device.

6. The delivery device according to claim 1, characterized in that The delivery shaft extends distally from the handle assembly.

7. The delivery device according to claim 5, characterized in that Further comprising a cannula handle, a pusher shaft and a cannula shaft, and wherein a distal end portion of the cannula shaft is configured to cover the docking device.

8. The delivery device according to claim 1, characterized in that The distal end portion of the delivery shaft is configured to be steerable.

9. The delivery device according to claim 7, characterized in that The handle assembly further includes a hub assembly to which the stitch lock assembly and the cannula handle are attached.

10. The delivery device according to claim 9, characterized in that The hub assembly is configured to independently control the impeller shaft and the quill shaft, and the quill handle is configured to control an axial position of the quill shaft relative to the impeller shaft.

11. The delivery device according to claim 10, characterized in that The hub assembly is coupled to the handle via a connector.

12. The delivery device of claim 1, wherein The handle assembly also includes one or more irrigation ports to supply irrigation fluid to one or more lumens disposed within the delivery device.

13. The delivery device according to claim 9, characterized in that The hub assembly includes a Y-shaped connector having a straight section and at least one branch.

14. The delivery device according to claim 13, characterized in that The stitch lock assembly is attached to the at least one branch, and the cannula handle is disposed at a proximal end of the straight section.

15. The delivery device of claim 1, wherein The suture lock assembly includes a rotator to increase and decrease tension on the released suture.

16. The delivery device of claim 15, characterized in that The stitch lock assembly includes a spool to which the rotator is coupled.

17. The delivery device of claim 15, characterized in that The spinner includes one or more gripping portions or grips and an indicator.

18. The delivery device of claim 1, wherein The suture lock assembly also includes a direction control mechanism including a direction selector that allows a medical professional or user to select whether to increase or decrease slack in the suture passing through the delivery device.

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