Suture locking assembly having a suture tensioner

Abstract

A suture locking assembly having a suture tensioner is disclosed herein. The suture locking assembly can include a suture tensioner configured to selectively rotate to gather a length of suture. The suture tensioner includes a pair of spaced posts and a connection body coupled to each of the posts. The suture locking 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 inlet port and a suture outlet port. The suture tensioner is configured to selectively rotate relative to the tensioner housing to selectively increase the length of suture surrounded by the tensioner housing. The quick release suture mechanism includes a quick release dock port and a suture anchor cap configured to selectively couple to and decouple from the quick release dock port.

Description

Technical Field

[0001] (Cross - Reference to Related Applications) This application claims the benefit of U.S. Provisional Patent Application No. 63 / 366,731, filed on June 21, 2022, which is hereby incorporated by reference in its entirety.

[0002] The present disclosure relates to a suture locking assembly having a suture tensioner that can be utilized with a delivery device for delivering an artificial implant into a patient's body.

Background Art

[0003] The human heart is susceptible to various valvular diseases. These valvular diseases can cause severe heart dysfunction and may ultimately require either repairing the native valve or replacing the native valve with an artificial valve. A number of repair devices (e.g., stents) and artificial valves are known, and also a number of methods for implanting those devices and valves into a human are known. By using percutaneous and minimally invasive surgical approaches in various procedures, artificial medical devices are delivered to locations inside the body that are not easily accessible surgically or to locations where access without surgery is desirable. In one specific example, an artificial heart valve may be mounted in a crimped state on the distal end of a delivery device, advanced through a patient's vasculature (e.g., through the femoral artery and aorta), and the artificial heart valve may be brought to an implantation site within the heart. Thereafter, the artificial heart valve may be expanded to its functional size, for example, by inflating a balloon to which the artificial valve is attached, or by actuating a mechanical actuator that applies an expanding force to the artificial heart valve, or by deploying the artificial heart valve from the sheath of the delivery device such that it can self - expand to its functional size.

Summary of the Invention

[0004] Delivery devices and methods for implanting an artificial heart valve are described herein. The disclosed delivery devices and methods can provide an improved releasable suture connection, for example, to an artificial heart valve and / or a docking device for anchoring the artificial heart valve. Thus, the devices and methods disclosed herein can overcome, among other things, one or more deficiencies associated with typical artificial heart valves and their delivery devices.

[0005] A delivery device for an artificial implant can include a handle and one or more shafts coupled to the handle.

[0006] In some embodiments, the one or more shafts include a delivery shaft configured to advance through a patient's vasculature to a implantation site and to hold an implantable device.

[0007] In some embodiments, the implantable device includes a docking device.

[0008] In some embodiments, the delivery device includes a pusher assembly configured to deploy and / or implant the implantable device at the implantation site.

[0009] In some embodiments, the implantable device is coupled to the delivery device via a suture that can be cut to remove the implantable device from the delivery device.

[0010] In some embodiments, the delivery device includes a suture locking assembly configured to engage the suture.

[0011] In some embodiments, the suture locking assembly includes a suture tensioner configured to engage the suture.

[0012] In some embodiments, the suture tensioner is configured to selectively increase or decrease the tension of the suture.

[0013] In some embodiments, the suture tensioner is configured to selectively rotate about the tensioner central axis to gather the length of the suture.

[0014] In some embodiments, the suture tensioner comprises a pair of spaced posts, each post being configured to rotate about the tensioner central axis as the suture tensioner rotates.

[0015] In some embodiments, the suture tensioner is configured to rotate between a plurality of tensioner configurations, including a release configuration in which the suture tensioner is positioned so as not to apply force to the suture and a full-tension configuration in which the posts are positioned to engage the suture so as to provide maximum tension to the suture when the suture is connected to the implantable device.

[0016] In some embodiments, the suture locking assembly comprises a tensioner housing that at least partially receives the suture tensioner.

[0017] In some embodiments, the suture locking assembly comprises a quick-release suture mechanism configured to selectively transition between a locked configuration and an unlocked configuration, the quick-release suture mechanism being configured such that the suture can be removed from the suture locking assembly when the quick-release suture mechanism is in the unlocked configuration.

[0018] In some embodiments, the quick-release suture mechanism comprises a quick-release docking port and a suture anchor cap configured to be selectively coupled to and decoupled from the quick-release docking port.

[0019] In one representative embodiment, the suture locking assembly comprises a suture tensioner configured to engage a suture and configured to be connected to an implantable device. The suture tensioner is configured to selectively rotate about a tensioner central axis to gather the length of the suture. The suture tensioner includes a pair of spaced posts and a connection body coupled to each of the posts. Each post is configured to rotate about the tensioner central axis as the suture tensioner rotates.

[0020] In another representative embodiment, the suture locking assembly comprises a suture tensioner, a tensioner housing, and a quick release suture mechanism. The suture tensioner is configured to engage a suture and is configured to be connected to a transplantable device. The tensioner housing at least partially receives the suture tensioner and includes a suture inlet port and a suture outlet port through which the suture extends between the suture inlet port and the suture outlet port. The quick release suture mechanism is coupled to the suture outlet 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 surrounded by the tensioner housing. The suture tensioner includes a pair of spaced posts and a connection body coupled 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 dock port and a suture anchor cap. The quick release dock port is configured to be attached to the suture outlet port, and the suture anchor cap is configured to be selectively coupled to and decoupled from the quick release dock port. The quick release suture mechanism is configured to selectively transition between a locking configuration in which the quick release suture mechanism maintains the suture in a fixed position relative to the suture outlet port and a release configuration in which the suture can be removed from the suture outlet port. The quick release suture mechanism is in the locking configuration when the suture anchor cap is operably coupled to the quick release dock port, and the quick release suture mechanism is in the release configuration when the suture anchor cap is removed from the quick release dock port. The suture extends between and terminates at each of a suture anchor end and a suture free end.The suture anchor cap has a suture anchor position, and the suture anchor cap is configured to be operably coupled to the suture anchor end at the suture anchor position such that the suture anchor end is restricted from being removed from the suture anchor cap during the operative use of the quick release suture mechanism.

[0021] In some embodiments, the suture locking assembly includes one or more of the components listed in Examples 59 - 126 below.

[0022] The various innovations in the present disclosure can be used in combination or individually. This summary is provided to introduce, in a simplified form, a selection of various concepts that are further described in the detailed description below. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. The above and other objects, features, and advantages of the present disclosure will become more apparent from the following detailed description, from the claims, and from the accompanying drawings.

Brief Description of the Drawings

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DETAILED DESCRIPTION OF THE INVENTION

[0024] General Considerations Of course, the disclosed embodiments can be adapted to deliver and implant prosthetic devices within any of the native annuli of the heart (e.g., pulmonary annulus, mitral annulus, and tricuspid annulus) and can be used with any of a variety of delivery approaches (e.g., retrograde, antegrade, transseptal, transventricular, transatrial, etc.).

[0025] For the purposes of this description, certain aspects, advantages, and novel features of the embodiments of the present disclosure are described herein. The disclosed methods, devices, and systems should not be construed in any way as limiting. Instead, the present disclosure is directed to all novel and non-obvious features and aspects of the various disclosed embodiments, alone and in various combinations and sub-combinations. The methods, devices, and systems are not limited to any particular aspect, feature, or combination thereof, nor is it necessary for the disclosed embodiments to have any one or more particular advantages or solve any problems. The techniques from any one embodiment can be combined with the techniques described in any one or more of the other embodiments. Considering the many possible examples to which the principles of the disclosed techniques can be applied, it will be recognized that the examples illustrated are merely preferred examples and should not be regarded as limiting the scope of the disclosed techniques.

[0026] Although some operations of the disclosed embodiments are specifically described, as can be readily shown, of course, the format of this description includes rearrangements, except where a particular ordering is required by the particular language described below. For example, operations described sequentially may, in some cases, be rearranged or performed concurrently. Further, for simplicity, the accompanying drawings may not show the various ways in which the disclosed method can be used with other methods. Additionally, this specification may use terms such as "provide" or "achieve" to describe the disclosed method. These terms are high-level abstractions of the actual operations performed. The actual operations corresponding to these terms may vary depending on the particular embodiment and are readily recognizable by those skilled in the art.

[0027] 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. Additionally, the term "comprising" means "including". Further, the terms "coupled" and "connected" generally mean electrically, electromagnetically, and / or physically (e.g., mechanically or chemically) coupled or linked, and without specific contrary language, do not exclude the presence of intermediate elements between the coupled or associated items.

[0028] As used herein, the term "proximal" refers to the position, direction, or portion of a device that is closer to the user and farther from the implantation site. As used herein, the term "distal" refers to the position, direction, or portion of a device that is farther from the user and closer to the implantation site. Thus, for example, proximal movement of a device is movement of the device away from the implantation site and toward the user (e.g., out of the patient's body), while distal movement of a device is movement of the device away from the user and toward the implantation site (e.g., into the patient's body). The terms "longitudinal direction" and "axial direction" refer to an axis extending in the proximal and distal directions unless otherwise explicitly defined.

[0029] As used herein, the terms "approximately" and "about" mean the recited value and any value within 10% of the recited value. For example, "about 1 mm" means any value between about 0.9 mm and about 1.1 mm (including both ends).

[0030] As used herein, "e.g." means "for example", and "i.e." means "that is".

[0031] Directions and other relative references (e.g., inside, outside, top, bottom, etc.) may be used to facilitate the discussion of the drawings and the principles herein, but are not intended to be limiting. For example, certain terms such as "inside", "outside", "top", "down", "interior", and "exterior" and the like may be used. Such terms are used where applicable to clarify the description to some extent when dealing with relative relationships, particularly with respect to the illustrated examples. However, such terms are not intended to imply absolute relationships, positions, or directions. For example, simply by turning an object over, the "top" portion may become the "bottom" portion. Nevertheless, it is still the same portion, and the object remains the same. As used herein, "and / or" means "and" or "or" as well as "and" and "or".

[0032] Delivery technology To implant an artificial valve into the native aortic valve via a transfemoral delivery approach, the artificial valve is mounted in a radially compressed state along the distal end of the delivery device. The artificial valve and the distal end portion of the delivery device are inserted into the femoral artery and advanced into the descending aorta, through the descending aorta, around the aortic arch, and through the ascending aorta. The artificial valve is positioned inside the native aortic valve and expanded radially (e.g., by inflating a balloon, by actuating one or more actuators of the delivery device, or by deploying the artificial valve from a sheath to enable natural expansion of the artificial valve). Alternatively, the artificial valve can be implanted inside the native aortic valve via a transapical procedure, in which case the artificial 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 of the heart, and the artificial valve is positioned inside the native aortic valve. Alternatively, in a transaortic procedure, the artificial valve (on the distal end of the delivery device) is introduced into the aorta through a surgical incision in the ascending aorta, for example, through a partial J sternotomy or a small right parasternal thoracotomy, and then advanced through the ascending aorta towards the native aortic valve.

[0033] To implant an artificial valve into the native mitral valve via a transseptal delivery approach, the artificial valve is mounted in a radially compressed state along the distal end of the delivery device. The artificial valve and the distal end of the delivery device are inserted into the femoral vein and advanced into the inferior vena cava, through the inferior vena cava, into the right atrium, across the atrial septum (through a puncture performed within the atrial septum), into the left atrium, and towards the native mitral valve. Alternatively, the artificial valve can be implanted into the native mitral valve via a transapical procedure, in which case the artificial valve (on the distal end of the delivery device) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart, and the artificial valve is positioned inside the native mitral valve.

[0034] To implant an artificial valve inside a native tricuspid valve, the artificial valve is attached in a radially compressed state along a distal end portion of a delivery device. The artificial valve and the distal end of the delivery device are inserted into the femoral vein, advanced into the inferior vena cava, and through the inferior vena cava into the right atrium, where the artificial valve is positioned inside the native tricuspid valve. A similar approach can be used to implant an artificial valve inside a native pulmonary valve or the pulmonary artery, except that the artificial valve is advanced through the native tricuspid valve into the right ventricle and toward the pulmonary valve / pulmonary artery.

[0035] Another delivery approach is the transatrial approach, where the artificial valve (on the distal end of the delivery device) is inserted through a chest incision, and the incision is made through the atrial wall (right or left atrial wall) to access any of the native heart valves. Atrial delivery can also be performed from within a blood vessel, such as from a pulmonary vein, for example. Yet another delivery approach is the transventricular approach, where the artificial valve (on the distal end portion of the delivery device) is inserted through a chest incision, and the incision is made through the wall of the right ventricle (typically at the base of the heart or in the vicinity thereof) to implant the artificial valve inside the native tricuspid valve, or inside the native pulmonary valve, or inside the pulmonary artery.

[0036] In all delivery approaches, the delivery device can be advanced over a guidewire previously inserted into the patient's vasculature. Moreover, the disclosed delivery approaches are not intended to be limiting. Any artificial valve disclosed herein can be implanted using any of a variety of delivery procedures and any of a variety of delivery devices known in the art. Examples of the disclosed technology

[0037] Figures 1-4 illustrate an exemplary transcatheter heart valve replacement (e.g., mitral valve replacement) using a docking device 52 and an artificial heart valve 62, according to one embodiment. During the surgery, the user first creates a path to the patient's native heart valve using a guide catheter 30 (FIG. 1). The user then delivers and implants the docking device 52 to the patient's native heart valve using a docking device delivery apparatus 50 (FIG. 2A), and then removes the docking device delivery apparatus 50 from the patient 10 after implanting the docking device 52 (FIG. 2B). The user then implants the artificial heart valve 62 into the implanted docking device 52 using an artificial valve delivery apparatus 60 (FIG. 3A). The user then removes the artificial valve delivery apparatus 60 (FIG. 3B) and the guide catheter 30 (FIG. 4) from the patient 10.

[0038] FIG. 1 shows a first stage in a mitral valve replacement according to one embodiment, where a guide catheter 30 and a guide wire 40 are inserted into a blood vessel 12 of a patient 10 and navigated through the blood vessel 12 into the heart 14 of the patient 10 towards the native mitral valve 16. Together, the guide catheter 30 and the guide wire 40 can provide a path for a docking device delivery apparatus 50 and an artificial valve delivery apparatus 60 to navigate through and along the implantation site (native mitral valve 16 or native mitral valve annulus).

[0039] First, the user can first make an incision in the patient's body to access the blood vessel 12. For example, in the embodiment shown in FIG. 1, the user can make an incision in the patient's groin to access the femoral vein. Thus, in such an embodiment, the blood vessel 12 can be the femoral vein.

[0040] After making an incision in blood vessel 12, the user can insert, through the incision, into blood vessel 12, a guide catheter 30, a guide wire 40, and / or an additional device (e.g., an introducer device, or a transseptal puncture device). The guide catheter 30 (which may also be referred to as an "introducer device", "introducer", or "guide sheath") is configured to facilitate percutaneous introduction of various implant delivery devices (e.g., a docking device delivery device 50, and an artificial valve delivery device 60) into and through blood vessel 12, and may extend through blood vessel 12 and into the heart 14, but may stop in front of 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 may extend through blood vessel 12 and into the heart 14 while the handle 32 remains outside the patient 10's body, and may be manipulated by the user to manipulate the shaft 34 (Figure 1).

[0041] The guide wire 40 is configured to guide delivery devices (e.g., guide catheter 30, docking device delivery device 50, artificial valve delivery device 60, additional catheter, or the like), and their associated devices (e.g., docking device, artificial heart valve, or the like) to the implantation site within the heart 14, and thus may extend continuously through blood vessel 12 and into the left atrium 18 of the heart 14 (and, in some embodiments, through the native mitral valve 16 and into the left ventricle of the heart 14) (Figure 1).

[0042] In some cases, prior to inserting the guide wire 40 and the guide catheter 30, a transseptal puncture device, or catheter, may be used to first access the left atrium 18. For example, after making an incision in the blood vessel 12, the user may insert a transseptal puncture device through the incision into the blood vessel 12. The user may 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 may then make a small incision in the atrial septum 22 of the heart 14 to enable access from the right atrium 20 to the left atrium 18. The user may then insert and advance the guide wire 40 through the transseptal puncture device within the blood vessel 12 and through the incision in the atrial septum 22 and into the left atrium 18. Once the guide wire 40 is positioned within the left atrium 18 and / or the left ventricle 26, the transseptal puncture device may be removed from the patient 10. The user may then insert the guide catheter 30 into the blood vessel 12 and advance the guide catheter 30 within the left atrium 18 over the guide wire 40 (FIG. 1).

[0043] In some cases, an introducer device may be inserted through the lumen of the guide catheter 30 prior to inserting the guide catheter 30 into the blood vessel 12. In some cases, the introducer device may include a tapered end portion that extends from the distal tip of the guide catheter 30 and is configured to guide the guide catheter 30 into the left atrium 18 over the guide wire 40. Additionally, in some cases, the introducer device may include a proximal end portion that extends from the proximal end of the guide catheter 30. Once the guide catheter 30 reaches the left atrium 18, the user may remove the introducer device from within the guide catheter 30 and from the patient 10. Thus, only the guide catheter 30 and the guide wire 40 remain within the patient 10. The guide catheter 30 is then in a position to receive the implant delivery device and assist in guiding it into the left atrium 18 as further described below.

[0044] Figure 2A shows the second stage in an exemplary mitral valve replacement where a docking device 52 is implanted onto the native mitral valve 16 of a patient 10's heart 14 using a docking device delivery apparatus 50 (which may also be referred to as an "implant catheter" and / or "docking device delivery device").

[0045] 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 advance through a patient's vasculature (vessel 12) by a user to a implantation site (e.g., the native mitral valve 16), and may be configured to hold the docking device 52 within the distal end portion 53 of the delivery shaft 54. In some embodiments, the distal end portion 53 of the delivery shaft 54 holds the docking device 52 therein in a straight delivery configuration.

[0046] The handle 56 of the docking device delivery apparatus 50 is configured to be gripped and / or otherwise held outside the patient 10's body by a user to advance the delivery shaft 54 through the patient's vasculature (e.g., vessel 12).

[0047] In some embodiments, the handle 56 may include one or more articulating members 57 (or rotatable knobs) configured to assist in navigating the delivery shaft 54 through the patient's vessel 12. For example, the one or more articulating members 57 may include one or more of knobs, buttons, wheels, and / or other types of physically adjustable control members configured to be adjusted by a user to bend, flex, twist, rotate, and / or otherwise articulate the distal end portion 53 of the delivery shaft 54 to assist in navigating the delivery shaft 54 through the patient's vessel 12 and into the heart 14.

[0048] The pusher assembly 58 can be configured to deploy and / or implant the docking device 52 at the implantation site (e.g., the native mitral valve 16). For example, the pusher assembly 58 can be configured to be adjusted by a user to push the docking device 52 out from the distal end portion 53 of the delivery shaft 54. The shaft of the pusher assembly 58 can extend through the delivery shaft 54 and can be positioned adjacent to the docking device 52 within the delivery shaft 54. In some embodiments, the docking device 52 can be removably coupled to the shaft of the pusher assembly 58 via a connection mechanism of the docking device delivery apparatus 50 such that the docking device 52 can be released after the docking device 52 is deployed at the native mitral valve 16.

[0049] Further details of the docking device delivery apparatus, and variations thereof, are described in International Publication No. WO2020 / 247907, which is hereby incorporated by reference in its entirety.

[0050] Referring again to FIG. 2A, after the guide catheter 30 is positioned within the left atrium 18, the user can insert the docking device delivery apparatus 50 (e.g., the delivery shaft 54) into the patient 10 by advancing the delivery shaft 54 of the docking device delivery apparatus 50 over the guide wire 40 through the guide catheter 30. In some embodiments, the guide wire 40 can be at least partially retracted into the guide catheter 30 away from the left atrium 18. The user can then continue to advance the delivery shaft 54 of the docking device delivery apparatus 50 along the guide wire 40 through the blood vessel 12 until the delivery shaft 54 reaches the left atrium 18 as shown in FIG. 2A. Specifically, the user can advance the delivery shaft 54 of the docking device delivery apparatus 50 by gripping the handle 56 of the docking device delivery apparatus 50 and applying a force (e.g., pushing) toward the patient 10. While advancing the delivery shaft 54 through the blood vessel 12 and the heart 14, the user can adjust one or more articulating members 57 of the handle 56 to navigate various bends, corners, stenoses, and / or other obstructions of the blood vessel 12 and the heart 14.

[0051] When the delivery shaft 54 reaches the left atrium 18 and extends beyond the distal end of the guide catheter 30, the user can use the handle 56 (e.g., the articulating members 57) to position the distal end portion 53 of the delivery shaft 54 behind and / or near the posterior medial commissure of the native mitral valve 16. The user can then use the shaft of the pusher assembly 58 to extrude the docking device 52 out of the distal end portion 53 of the delivery shaft 54 and deploy and / or implant the docking device 52 within the annulus of the native mitral valve 16.

[0052] In some embodiments, the docking device 52 may be constructed from, formed from, and / or include a shape memory material such that when the docking device exits the delivery shaft 54 and is no longer constrained by the delivery shaft 54, it can return to its original pre-formed shape. As an example, the docking device 52 may originally be formed as a coil and thus can wrap around the valve tip 24 of the native mitral valve 16 when exiting the delivery shaft 54 and returning to its original coiled configuration.

[0053] After pressing on the ventricular portion of the docking device 52 (e.g., a portion of the docking device 52 shown in FIG. 2A 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 posterior medial commissure of the native mitral valve 16.

[0054] After deploying and implanting the docking device 52 onto the native mitral valve 16, the user can disconnect the docking device delivery apparatus 50 from the docking device 52. When the docking device 52 is disconnected from the docking device delivery apparatus 50, the user can store the docking device delivery apparatus 50 outside of the blood vessel 12 and away from the patient 10, such that the user can then deliver and implant the artificial heart valve 62 within the docking device 52 implanted on the native mitral valve 16.

[0055] Figure 2B shows this third stage in the mitral valve replacement procedure, where the docking device 52 is fully deployed and implanted into the native mitral valve 16, such that the docking device delivery apparatus 50 (including the delivery shaft 54) is removed from the patient 10, with the result that only the guide wire 40 and the guide catheter 30 remain within the patient 10. In some embodiments, after removal of the docking device delivery apparatus, the guide wire 40 can be advanced into the left ventricle 26 outside of the guide catheter 30 and through the docking device 52 implanted in the native mitral valve 16 (Figure 2A). Thus, the guide wire 40 can assist in guiding the artificial valve delivery apparatus 60 at least partially into the left ventricle 26 through the annulus of the native mitral valve 16.

[0056] As shown in Figure 2B, the docking device 52 can comprise a plurality of turns (or coils) that wrap around the leaflets 24 of the native mitral valve 16 (within the left ventricle 26). The implanted docking device 52 has a cylindrical shape that is greater than the annulus of the native mitral valve 16, thereby providing a geometric shape that more closely matches the shape, or profile, of the implanted artificial heart valve. As a result, the docking device 52 can provide a tighter fit, and thus a better seal, between the artificial heart valve and the native mitral valve 16, as further described below.

[0057] Figure 3A shows the fourth stage in the mitral valve replacement procedure, where the user uses the artificial valve delivery apparatus 60 to deliver and / or implant an artificial heart valve 62 (which may also be referred to herein as a "transcatheter heart valve", or more simply as a "THV", "replacement heart valve", and / or "artificial mitral valve").

[0058] As shown in FIG. 3A, the artificial valve delivery device 60 includes a delivery shaft 64 and a handle 66, and the delivery shaft 64 extends distally from the handle 66. The delivery shaft 64 is configured to extend into the patient's vasculature to deliver, implant, expand, and / or otherwise deploy the artificial heart valve 62 within the docking device 52 to 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.

[0059] In some embodiments, the handle 66 may include one or more articulating members 68 configured to assist in navigating the delivery shaft 64 through the blood vessel 12 and the heart 14. Specifically, the articulating member 68 may be joined by a user in a bending, flexing, twisting, rotating, and / or otherwise engaging manner to bend the distal end portion of the delivery shaft 64 to assist in navigating the delivery shaft 64 through the patient's blood vessel 12 to the left atrium 18 and the left ventricle 26 of the heart 14. It may include one or more of a knob, button, wheel, and / or other type of physically adjustable control member configured to be adjusted.

[0060] In some embodiments, the artificial valve delivery device 60 may include an expansion mechanism 65 configured to radially expand and deploy the artificial heart valve 62 at the implantation site. In some cases, as shown in FIG. 3A, the expansion mechanism 65 may include an inflatable balloon configured to inflate to radially expand the artificial heart valve 62 within the docking device 52. The inflatable balloon may be coupled to the distal end portion of the delivery shaft 64.

[0061] In other embodiments, the prosthetic heart valve 62 can be self-expanding and configured to radially expand itself upon removal of a sheath, or capsule, covering the prosthetic heart valve 62 radially compressed on the distal end portion of the delivery shaft 64. In yet other embodiments, 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., an expansion mechanism) configured to radially expand the prosthetic heart valve 62.

[0062] As shown in FIG. 3A, the prosthetic heart valve 62 is attached in a radially compressed configuration around an expansion mechanism 65 (an inflatable balloon) on the distal end portion of the delivery shaft 64.

[0063] To navigate the distal end portion of the delivery shaft 64 to the implantation site, the user can insert the prosthetic valve delivery device 60 (delivery shaft 64) into the patient 10 through the guide catheter 30 and over the guide wire 40. As shown in FIG. 3A, the user can continue to advance the prosthetic 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. More specifically, the user can advance the delivery shaft 64 of the prosthetic valve delivery device 60 by gripping the handle 66 and applying force (e.g., pushing). The user can adjust one or more articulating members 68 of the handle 66 while advancing the delivery shaft 64 through the blood vessel 12 and the heart 14 to navigate various bends, corners, stenoses, and / or other obstacles within the blood vessel 12 and the heart 14.

[0064] The user can advance the delivery shaft 64 along the guide wire 40 until the radially compressed prosthetic heart valve 62 attached around the distal end portion of the delivery shaft 64 is positioned within the docking device 52 and the native mitral valve 16. In some embodiments, as shown in FIG. 3A, at least a portion of the distal end of the delivery shaft 64 and the radially compressed prosthetic heart valve 62 can be positioned within the left ventricle 26.

[0065] When the radially compressed artificial heart valve 62 is properly positioned within the docking device 52 (FIG. 3A), the user operates one or more actuating mechanisms of the handle 66 of the artificial valve delivery device 60 to activate the expansion mechanism 65 (e.g., inflate an inflatable balloon), thereby radially expanding the artificial heart valve 62 within the docking device 52.

[0066] FIG. 3B shows the fifth stage in mitral valve replacement, in which the artificial heart valve 62 is in its radially expanded configuration and implanted within the docking device 52 of the native mitral valve 16. As shown in FIG. 3B, the artificial heart valve 62 is received and held within the docking device 52. Therefore, the docking device 52 helps to anchor the artificial heart valve 62 within the native mitral valve 16. The docking device 52 allows for 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.

[0067] As shown in FIG. 3B, after the artificial heart valve 62 is fully deployed and implanted within the docking device 52 with 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 guide wire 40 and the guide catheter 30 remain inside the patient 10.

[0068] FIG. 4 shows the sixth stage in mitral valve replacement, in which the guide wire 40 and the guide catheter 30 have been removed from the patient 10.

[0069] Figures 1-4 specifically illustrate a mitral valve replacement, but it should be understood that the same techniques, and / or similar techniques, may be utilized to replace other heart valves (e.g., tricuspid valve, pulmonary valve, and / or aortic valve). Further, the same, and / or similar delivery devices (e.g., docking device delivery device 50, artificial valve delivery device 60, guide catheter 30, and / or guide wire 40), docking devices (e.g., docking device 52), replacement heart valves (e.g., artificial heart valve 62), and / or their components may be utilized to replace these other heart valves.

[0070] For example, when replacing the native tricuspid valve, the user may access the right atrium 20 via the femoral vein, but does not need to cross the atrial septum 22 to enter the left atrium 18. Instead, the user may leave the guide wire 40 within 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 within 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 guide wire 40 through the tricuspid valve into the right ventricle and perform the same, and / or similar, artificial heart valve implantation process within the docking device 52 at the tricuspid valve. Specifically, the user may advance the delivery shaft 64 of the artificial valve delivery device 60 along the guide wire 40 through the patient's vasculature until the artificial heart valve 62 is positioned / disposed within the docking device 52 and the tricuspid valve. The user may then expand the artificial heart valve 62 within the docking device 52 before removing the artificial valve delivery device 60 from the patient 10. In another embodiment, the user may perform the same, and / or similar, process to replace the aortic valve, but may access the aortic valve from the outflow side of the aortic valve via the femoral artery.

[0071] Furthermore, FIGS. 1-4 illustrate a mitral valve replacement that accesses the native mitral valve 16 from the left atrium 18 via the right atrium 20 and the femoral vein, but it should be understood that the native mitral valve 16 can alternatively be accessed from the left ventricle 26. For example, the user can access the native mitral valve 16 from the left ventricle 26 via the aortic valve by advancing one or more delivery devices through the artery to the aortic valve and then through the aortic valve into the left ventricle 26.

[0072] FIG. 5 shows a docking device 70 according to one embodiment. In some embodiments, the docking device 70 can be used as the docking device 52 in an artificial valve implantation procedure, as described above with reference to FIGS. 1-4. As shown in FIG. 5, the docking device can be configured to receive and secure an artificial valve within the docking device, thereby fixing the artificial valve to the native valve annulus.

[0073] The docking device 70 can include a coil 72 and a guard member 74 that covers at least a portion of the coil 72. In certain embodiments, the coil 72 can be made of a shape memory material (e.g., nickel-titanium alloy, or "nitinol") such that the docking device 70 (and the coil 72) can move from a substantially straight configuration (delivery configuration) when the docking device 70 is disposed within the delivery shaft 54 of the delivery device 50 to a helical deployment configuration after being removed from the delivery shaft 54.

[0074] Coil 72 has a proximal end 72p and a distal end 72d (which also respectively define the proximal end and distal end of docking device 70). When disposed within delivery shaft 54 (e.g., during delivery of docking device 70 into a patient's vasculature), the body of coil 72 between proximal end 72p and distal end 72d generally forms a straight delivery configuration (i.e., having no coiled or looped portions, but can be bent or curved) so as to maintain a small radial profile when moving through the patient's vasculature. After being removed from delivery shaft 54 and deployed at the implantation site, coil 72 moves from the delivery configuration to a helical deployment configuration and can wrap around native tissue adjacent to the implantation site. For example, when implanting the docking device at the location of a native valve, coil 72 can be configured to surround the native valve leaflets of the native valve (and the chordae tendineae that connect the native valve leaflets to adjacent papillary muscles, if present).

[0075] Docking device 70 can be releasably coupled to docking device delivery apparatus 50. For example, in certain embodiments, docking device 70 can be coupled to the delivery apparatus via a release suture (described further below) that is configured to be tied to docking device 70 and severed for removal.

[0076] As shown in FIG. 5, coil 72 in the deployment configuration can include a leading turn 76 (or “leading coil”), a central region 78, and a stabilizing turn 80 (or “stabilizing coil”) around a central longitudinal axis. Central region 78 can have one or more helical turns with substantially equal inner diameters. Leading turn 76 can extend from the distal end of central region 78 and have a diameter larger than the diameter of central region 78 in the illustrated embodiment. Stabilizing turn 80 can extend from the proximal end of central region 78 and have a diameter larger than the diameter of central region 78 in the illustrated embodiment.

[0077] Further details of the docking device delivery device and its variations are described in International Patent Application PCT / US2021 / 056150, which is hereby incorporated by reference in its entirety.

[0078] FIG. 6A shows a delivery device 200 configured to implant a docking device 70 (FIG. 5) described below, or other docking devices, according to one embodiment, into a target implantation site within a patient. In some embodiments, the delivery device 200 can be used as a docking device delivery device 50 in an artificial valve implantation procedure, as described above with reference to FIG. 2A. The delivery device 200 can also be referred to as a "docking device delivery device", a "dock delivery catheter", or a "dock delivery system".

[0079] As shown, the delivery device 200 can include a handle assembly 202 and a delivery shaft 204 (also referred to as a "delivery shaft", an "outer shaft", or an "outer sheath") that extends distally from the handle assembly 202. The handle assembly 202 can include a handle 206 that includes one or more knobs, buttons, wheels, and / or other means for controlling and / or actuating one or more components of the delivery device 200. For example, in some embodiments, as shown in FIG. 6A, the handle 206 can include knobs 208 and 210 configured to steer or control the bending of the delivery device 200, such as the delivery shaft 204 and / or the sleeve shaft 220 described below.

[0080] In certain embodiments, the delivery device 200 can also include 224, 212, and a sleeve shaft 220, both of which can extend through the inner lumen of the delivery shaft 204 and can have respective proximal end portions that extend into the handle assembly 202.

[0081] As described below, the distal end portion of the sleeve shaft 220 (also referred to as the "distal section") can be configured to cover (e.g., surround) the docking device 70 (see FIG. 5). For example, the docking device 70 can be held inside the sleeve shaft 220, which is further held by the distal end portion 205 of the delivery shaft 204 when navigating through the patient's vasculature.

[0082] In addition, the distal end portion 205 of the delivery shaft 204 can be configured to be steerable. In one embodiment, the curvature of the distal end portion 205 can be adjusted so that by rotating a knob (e.g., 208, or 210) on the handle 206, the distal end portion 205 of the delivery shaft 204 can be oriented at a desired angle. For example, to implant the docking device 70 in the position of the native mitral valve, the distal end portion 205 of the delivery shaft 204 can be steered within the left atrium so that the sleeve shaft 220, and the docking device 70 held therein, can extend through the native mitral valve annulus in a posterior medial commissure adjacent to one.

[0083] In certain embodiments, the pusher shaft 212 and the sleeve 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 sleeve 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 sleeve shaft 220 and can be pushed against the proximal end of the docking device 70 held inside the sleeve shaft 220.

[0084] After reaching the target implantation site, the docking device 70 can be deployed from the delivery shaft 204 by operating the pusher shaft 212 and the sleeve shaft 220 using the hub assembly 218, as further described below. For example, by pushing the pusher shaft 212 distally while holding the delivery shaft 204 in place, or by retracting the delivery sheath 204 proximally while holding the pusher shaft 212 in place, or by pushing the pusher shaft 212 distally while simultaneously retracting the delivery shaft 204 proximally, the docking device 70 can be pushed out beyond the distal end 204d of the delivery shaft 204, and thus the docking device 70 can be transitioned from the delivery configuration to the deployed configuration (see FIG. 5). In certain embodiments, the pusher shaft 212 and the sleeve shaft 220 can operate independently of each other.

[0085] During delivery, the docking device 70 can be coupled to the delivery device 200 via a release suture (not shown in FIG. 6A) or via another retrieval line that includes a string, yarn, or other material that extends through the pusher shaft 212 and is configured to be tied around the docking device 70 and cut for removal. In one specific embodiment, the release suture can extend through the delivery device 200, for example, through the lumen of the pusher shaft 212, to the suture locking assembly 216 of the delivery device 200.

[0086] The handle assembly 202 may further include a hub assembly 218 to which a suture locking assembly 216 and a sleeve handle 224 are attached. The hub assembly 218 may be configured to independently control a pusher shaft 212 and a sleeve shaft 220, while the sleeve handle 224 may control the axial position of the sleeve shaft 220 relative to the pusher shaft 212. In this way, 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 embodiments, the hub assembly 218 may be coupled to the handle 206 via a connector 226.

[0087] The handle assembly 202 may further include one or more flushing ports (e.g., flushing port 232 shown in FIG. 6A) for supplying flush fluid to one or more lumens disposed within the delivery device 200 (e.g., an annular lumen disposed between coaxial components of the delivery device 200).

[0088] FIGS. 6B - 6D show the aspects of the handle assembly 202 and / or the suture locking assembly 216 of FIG. 6A in more detail. As shown, the hub assembly 218 may include a Y - shaped connector (e.g., an adapter) 240 having a straight section (e.g., a straight conduit) 242 and at least one branch (e.g., a branched conduit) 244 (however, in some embodiments, may include multiple branches). In some embodiments, the suture locking assembly 216 may be attached to the branch 244, and the sleeve handle (e.g., a sleeve actuating handle) 224 may be disposed at the proximal end of the straight section 242.

[0089] As shown in FIGS. 6A - 6D and introduced above, the delivery device 200 may include a suture locking assembly 216 located on the branch 244 of the hub assembly 218 of the handle assembly 202. As described below, an exemplary suture locking assembly 216 may include a release knob 284 that may be screwed onto the end of the Y - shaped connector 240.

[0090] As shown in FIG. 6B, the hub assembly 218 can include a flushing port 234 configured to enable flushing of one or more lumens within the delivery device 200 to sterilize and / or maintain hemostasis within the delivery device 200.

[0091] As described above, a medical professional can deploy a docking device (e.g., docking device 70) by manipulating the position of the handle assembly 202 and can add only one additional step of retracting the sleeve by pulling on the sleeve handle 224. The sleeve shaft (e.g., sleeve shaft 220) and the pusher shaft (e.g., pusher shaft 212) can be configured to cooperate such that they can move together when deploying and positioning the docking device onto a native valve (e.g., by moving the entire hub assembly 218 and / or Y - connector 240 forward and / or backward). Further, the sleeve shaft and the pusher shaft can be configured to move independently such that the pusher shaft can hold the docking device in place while the sleeve shaft retracts from the docking device (e.g., when pulling the sleeve shaft out by pulling the sleeve handle 224 in the proximal direction and holding 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). The sleeve shaft and the pusher shaft can be co - axial along some, all, or most of the delivery device 200 as described above, thereby facilitating their functioning together.

[0092] As shown in FIGS. 6A - 6D, the suture locking assembly 216, as described above, can include a rotator 272 (which can also be referred to as a "rotatable handle") that extends from the suture locking assembly 216, through the branch 244, through the handle 222, and through the delivery shaft 204 to connect to a docking device, and can increase or decrease the tension on a release suture 236 (shown in FIG. 6B).

[0093] In certain embodiments, the release suture 236 can be wound around a spool 278 of the suture locking assembly 216 (see, e.g., FIG. 6C). The rotator 272 can be coupled to the spool 278 such that rotating the rotator 272 in a given direction can adjust (e.g., increase or decrease) the tension on the release suture 236 that traverses the delivery device 200. By rotating the rotator 272 (and thus the spool 278), providing tension or slack to the release suture 236 can cause the docking device 70 and the delivery device 200 to move closer to or farther from each other, respectively. As used herein, the spool 278 can also be referred to as a spindle 278.

[0094] In some embodiments, the rotator 272 can include one or more gripping portions or grips that increase the ease of gripping the rotator 272 (e.g., via a user's hand) without slipping. For example, as shown in FIG. 3, the rotator 272 can include a gripping portion 273 that is disposed around the circumference of the rotator 272 and is configured to be gripped by a user during rotation of the rotator 272. In some embodiments, the gripping portion 273 can include a plurality of ridges to increase the traction and ease of gripping. In some embodiments, the gripping portion 273 can include a material having a lower durometer (e.g., reduced hardness) than the material forming another portion of the rotator 272.

[0095] In some embodiments, as shown in FIG. 6B, the rotator 272 can include an indicator 275 for tracking the number of turns (or a portion thereof) applied, which can then be correlated with the degree of slack or tension of the release suture 236.

[0096] In some embodiments, the suture locking assembly 216 may further include a direction control mechanism that may include a direction selector 274 (e.g., in the form of a switch as shown in FIGS. 6B-6C), whereby a physician, or other user, can select whether to increase or decrease the slack of the release suture 236 across the delivery device 200. For example, the direction selector 274 may be configured such that a physician, or other user, can select a direction (e.g., to increase or decrease tension), thereby enabling the rotator 272 to rotate in only one direction and preventing rotation in the wrong direction.

[0097] In some embodiments, as shown in FIG. 6C, the housing 262 of the suture locking assembly 216 may include a first icon 264 indicating the slack position of the direction selector 274 and a second icon 266 indicating the tension position of the direction selector 274.

[0098] Further details regarding the direction control mechanism of the suture locking assembly (such as suture locking assembly 216) are described in International Patent Application No. PCT / US2020 / 36577, the disclosure of which is incorporated herein by reference.

[0099] In certain embodiments, the suture locking assembly 216 may include a connector, or connection portion, for attaching the suture locking assembly 216 to a handle assembly (e.g., handle assembly 202). For example, the suture locking assembly 216 may include a release bar 282 that extends into and couples with the housing 262 of the suture locking assembly 216 (see, e.g., FIG. 6C). In some embodiments, the release bar 282 may be coupled to the housing 262 (e.g., via an adhesive, welding, or other non-removable fixing means). As shown in FIG. 6C, a release knob 284 may be disposed around a portion of the release bar 282 adjacent to the connection portion 286 of the bottom housing 268. The release knob 284 may be configured to connect the suture locking assembly 216 to the adapter 240 of the delivery device.

[0100] As described above and as shown in FIG. 6B, the adapter 240 can include a branch 244 and a straight section 242. In the illustrated example, the release knob 284 can be screwed onto the end of the adapter 240 (e.g., the proximal end of the branch 244) to secure the suture locking assembly 216 to the adapter 240. In some embodiments, the shape, size, and / or configuration of the adapter 240 can differ from that shown in FIG. 6B and can vary based on the delivery device configured such that the suture locking assembly 216 is attached (and used).

[0101] In certain embodiments, when the release knob 284 is coupled to each of the adapter 240 (or another adapter of the delivery device) and the release bar 282, the suture locking assembly 216 can be coupled to the delivery device and the suture cutting section 254 can be covered by the adapter 240 (e.g., as shown in FIG. 6C). In some embodiments, when a docking device (or other implant) is positioned in a desired location to be released from the delivery device, the release knob 284 can be loosened from the adapter 240 to release the suture locking assembly 216 from the adapter 240, and the suture locking assembly 216 can be pulled proximally away from the adapter 240 to expose the suture cutting section 254. In an alternative embodiment, rotation of the release knob 284 (e.g., to move the release knob 284 toward the housing 262) can expose the suture cutting section 254 without pulling the entire suture locking assembly 216 away from the adapter 240.

[0102] The suture cutting section 254 can be configured to allow a user, or a physician, to cut a release suture 236 that traverses the length of the delivery device to enable cutting of the docking device from the delivery device during its deployment at the target implantation site.

[0103] In some embodiments, when the release suture 236 is wound around the docking device or the implant and routed through the delivery device and through the release bar 282 (including across the suture cutting section 254) into the housing 262, the two suture ends of the release suture 236 are screwed through two openings disposed at the bottom of the spool 278 and then tied off to complete a suture loop.

[0104] As shown in FIGS. 6A and 6D, the suture locking assembly 216 can include a flushing port 215 that allows for flushing of one or more lumens within the delivery device to reduce thrombus formation between components of the delivery device, maintain hemostasis within the delivery device, and / or sterilize the delivery device. In certain cases, the flushing port 215 can be configured to allow for independent flushing of the lumen(s) in the event that a single flush line becomes blocked and / or hemostasis is not maintained within the delivery device. In certain cases, the flushing port 215 can be an open port to allow for a constant flow through the delivery device. In certain embodiments, the flushing port 215 can be configured as self-sealing such that fluid can be introduced into the delivery device at the discretion of the physician without the need for a constant flow. The flushing port 215 shown in FIG. 6D allows for connection of additional flush lines, similar to the plurality of flushing ports such as the flushing port 232 shown in FIG. 6A and / or the flushing port 234 shown in FIG. 6B. For simplicity, the flushing port 215 is not shown in FIGS. 6B-6C, however, it should be understood that the suture locking assembly 216 shown in FIGS. 6B-6C can also include the flushing port 215.

[0105] Further details regarding delivery devices / catheters / systems (including various embodiments of the handle assembly) configured to deliver a docking device to a target implantation site can be found in International Application PCT / US2020 / 036577, as well as U.S. Patent Publication Nos. 2018 / 0318079 and 2018 / 0263764, each of which is hereby incorporated by reference in its entirety.

[0106] As described above, when the docking device 70 is implanted at the target implantation site, the release suture 236 is decoupled from the docking device 70. In the embodiments of FIGS. 6A - 6D, this is accomplished by removing the suture locking assembly 216 from the hub assembly 218 and exposing a suture cutting section 254 in which the release suture 236 can be cut. In other embodiments, and as discussed below, the suture locking assembly can be configured to remain coupled to the hub assembly 218 and / or the delivery device 200 while the release suture is removed from the docking device. As will be described in more detail below, such devices can facilitate removal of the release suture 236 from the docking device 70.

[0107] FIG. 7 schematically illustrates an embodiment of a suture locking assembly 300 that includes a quick release suture mechanism 302 configured to facilitate releasing the release suture 236 from an implantable device (such as the docking device 70). The suture locking assembly 300 may include any of the features, characteristics, attributes, etc. disclosed herein with reference to the suture locking assembly 216, and vice versa. In particular, FIG. 7 shows an embodiment in which the suture locking assembly 300 includes a spool 340 (which may be similar or identical to the spool 278) for collecting and / or adjusting the tension of the length of the release suture 236. The suture locking assembly 300 further includes a tensioner housing 350 that at least partially receives the spool 340.

[0108] Figures 8-10, 14A-15G, and 15I-15M show some additional examples of the quick release suture mechanism 302, as described in more detail below. In particular, FIG. 8 shows a first exemplary quick release suture mechanism 302a, FIG. 9 shows a second exemplary quick release suture mechanism 302b, and FIGS. 10A-10D show a third exemplary quick release suture mechanism 302c. FIGS. 14A-14B show a fourth exemplary quick release suture mechanism 302d, and FIGS. 15A-15G, and 15I-15M show a fifth exemplary quick release suture mechanism 302e. Generally, the features, characteristics, attributes, etc. of the quick release suture mechanism 302 disclosed herein with reference to FIG. 7 are also applicable to any of the quick release suture mechanisms 302a / 302b / 302c / 302d / 302e, and vice versa, it can be understood.

[0109] The present disclosure generally relates to embodiments in which the suture locking assembly 300, and / or the quick release suture mechanism 302 is used with the release suture 236, but this is not required, and furthermore, it is within the scope of the present disclosure that the suture locking assembly 300, and / or the quick release suture mechanism 302 can be used with any suitable suture. For example, the suture locking assembly 300, and / or the quick release suture mechanism 302 can be used with sutures that are not configured to be coupled to and / or released from an implantable device. Thus, as used herein, the release suture 236 can additionally or alternatively be referred to as the suture 236.

[0110] Furthermore, while the present disclosure generally relates to embodiments in which the quick release suture mechanism 302 is used with the suture locking assembly 300, this is not required. For example, it is within the scope of the present disclosure that the quick release suture mechanism 302 can be used independently of the suture locking assembly or an associated suture tensioning mechanism. In particular, in some embodiments, the docking device delivery device 50 and / or the prosthetic valve delivery device 60 do not include a mechanism for adjusting the degree of slack in the release suture 236, but can still be used with the quick release suture mechanism 302 to release the release suture 236.

[0111] In the present disclosure, reference numbers that include alphanumeric labels (e.g., "a", "b", "c", etc.) should be understood to identify particular embodiments of the structures or components corresponding to the reference numbers. Thus, it will be understood that components that share the same name and / or the same reference number can share any of the characteristics and / or features disclosed herein, even when a particular such component is not specifically described and / or referred to herein. It should be further understood that such components that share the same name and / or the same reference number can share any characteristics and / or features even in embodiments where the same reference number does not include alphanumeric labels. As an example, the quick release suture mechanism 302 of FIG. 11, the quick release suture mechanism 302a of FIG. 8, the quick release suture mechanism 302b of FIG. 9, the quick release suture mechanism 302c of FIGS. 10A-10D can share any suitable characteristics and / or properties with the quick release suture mechanism 302d of FIGS. 14A-14B, and / or the quick release suture mechanism 302e of FIGS. 15A-15G and 15J-15K. Further, in the present disclosure, features and / or attributes related to multiple embodiments (e.g., embodiments indicated by reference numbers each including an alphanumeric label) can be presented and / or discussed with reference to corresponding reference numbers lacking alphanumeric labels.

[0112] The tensioner housing 350 includes a suture inlet port 352 and a suture outlet port 354. As a result, the release suture 236 extends into the tensioner housing 350 through the suture inlet port 352 and extends out of the tensioner housing 350 through the suture outlet port 354. More specifically, the release suture 236 extends between the implantable device and the spool 340 through the suture inlet port 352, and the release suture 236 extends between the spool 340 and the quick-release suture mechanism 302 through the suture outlet port 354.

[0113] As shown in FIG. 7, the suture locking assembly 300 and / or the suture inlet port 352 can be configured to be operably coupled to the delivery device connection 306 of the delivery device 200. Thus, the suture locking assembly 300 can be configured such that the release suture 236 extends between the spool 340 and the implantable device through the delivery device connection 306. As an example, the delivery device connection 306 can represent and / or include a portion of the branch 244 of the adapter 240 shown in FIG. 6B.

[0114] As shown in FIG. 7, the quick-release suture mechanism 302 includes a quick-release dock port 304 configured to be attached to the suture outlet port 354, and a suture anchor cap 320 selectively coupled to and decoupled from the quick-release dock port 304. The quick-release suture mechanism 302 is configured to selectively transition between a locked configuration and an unlocked configuration.

[0115] The quick release suture mechanism 302 is in a locked configuration when the suture anchor cap 320 is operably coupled to the quick release dock port 304. In the locked configuration, the quick release suture mechanism 302 maintains the release suture 236 in a fixed position relative to the suture exit port 354 and / or relative to the quick release dock port 304 so as to limit and / or prevent the release suture 236 from being removed from the suture locking assembly 300 and / or from the implantable device.

[0116] The quick release suture mechanism 302 is in an unlocked configuration when the suture anchor cap 320 is removed from the quick release dock port 304. In the unlocked configuration, the release suture 236 can be removed from the suture exit port 354 and / or from the quick release dock port 304 such that the release suture 236 can be removed from the implantable device.

[0117] In this way, the quick release dock port 304 can facilitate removal of the release suture 236 from the implantable device without removing the suture locking assembly 300 from the delivery device connection 306 and / or without cutting the release suture. That is, in contrast to a suture locking assembly configured to be removed from a hub assembly to access and cut the release suture, removing the suture anchor cap 320 from the quick release dock port 304 provides the ability to access and remove the release suture 236 while the suture locking assembly 300 remains coupled to the delivery device connection 306.

[0118] The quick release dock port 304 may be a part of the tensioner housing 350 or may be a component operably coupled to the tensioner housing 350. For example, the quick release dock port 304 and the suture exit port 354 may be integrally formed and / or may refer to a common (e.g., the same) component.

[0119] When the quick release suture mechanism 302 is in the locked configuration, the suture locking assembly 300 can operate substantially the same as the suture locking assembly 216 of FIGS. 6A - 6D. 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 wind a portion of the release suture 236 around the spool 340, increase the tension of the release suture 236, and / or operate to reduce the length of the release suture 236 between the suture locking assembly 300 (and / or its suture inlet port 352) and the implantable device.

[0120] However, different from the embodiments of FIGS. 6A - 6D, the release suture 236 of the embodiment of FIG. 7 does not terminate on the spool 340. Instead, it passes through each of the suture inlet port 352 and the suture outlet port 354. Specifically, in the embodiment of FIG. 7, the quick release suture mechanism 302 is configured such that the release suture 236 extends from the quick release dock port 304 through the suture outlet port 354, through the suture inlet port 352 to the implantable device, and then back to the quick release dock port 304 via the suture inlet port 352 and the suture outlet port 354.

[0121] The suture anchor cap 320 can be configured to be operably coupled to the quick release dock port 304 in any of various manners. As shown in FIG. 7, the quick release suture mechanism 302 can include a dock port coupling mechanism 310 configured to selectively couple the suture anchor cap 320 to the quick release dock port 304. In particular, one or both of the suture anchor cap 320 and / or the quick release dock port 304 can include at least a portion of the dock port coupling mechanism 310.

[0122] In some embodiments, such as the embodiments of FIGS. 8-10D, the dock port coupling mechanism 310 includes a port thread 312 (e.g., an external thread) and a cap thread 322 (e.g., an internal thread) configured to engage with each other in a screwable manner to selectively couple the suture anchor cap 320 to the quick release dock port 304. Specifically, in such embodiments, the quick release dock port 304 includes the port thread 312, and the suture anchor cap 320 includes the cap thread 322. Thus, in such embodiments, the quick release suture mechanism 302 can be selectively transitioned from the locked configuration to the unlocked configuration by loosening the suture anchor cap 320 from the quick release dock port 304. The pitch of the port thread 312 and / or the cap thread 322 can be configured such that the suture anchor cap 320 can be removed from the quick release dock port 304 via a desired number of rotations of the suture anchor cap 320 relative to the quick release dock port 304 (e.g., less than one rotation, less than one rotation, or more than two rotations). FIGS. 8-10D show the port thread 312 as an external thread and the cap thread 322 as an internal thread, but it is also within the scope of the present disclosure that the port thread 312 can be an internal thread and the cap thread 322 can be an external thread.

[0123] In other embodiments, for example, in the embodiments of FIGS. 15A-15G and 15I-15M, the dock port coupling mechanism 310 may include, and / or may be, a bayonet locking coupling mechanism. Specifically, in the embodiments of FIGS. 15A-15G and 15I-15M, the dock port coupling mechanism 310e includes a bayonet pin 314e and a bayonet slot 324e configured to receive the bayonet pin 314e in a bayonet locking configuration. In the embodiments of FIGS. 15A-15G and 15I-15M, the quick release dock port 304e includes the bayonet pin 314e, and the suture anchor cap 320e includes the bayonet slot 324e. However, in other embodiments, the quick release dock port 304 may include the bayonet slot 324, and the suture anchor cap 320 may include the bayonet pin 314. The bayonet type coupling mechanism can, for example, enable the suture anchor cap 320 to be released from the quick release dock port 304 by rotating the suture anchor cap 320 less than one revolution (e.g., 1 / 4 revolution, 1 / 2 revolution, etc.) relative to the quick release dock port 304.

[0124] Thus, in such embodiments, the quick release suture mechanism 302 can be selectively transitioned from a locked configuration to an unlocked configuration by sequentially rotating the suture anchor cap 320 relative to the quick release dock port 304 and axially translating the suture anchor cap 320 away from the quick release dock port 304.

[0125] Such a two-step removal mechanism can protect against accidentally removing the suture anchor cap 320 from the quick release dock port 304. Additional or alternative embodiments of mechanisms for reducing the likelihood of accidentally removing the suture anchor cap 320 from the quick release dock port 304 can include two-step removal mechanisms (e.g., grenade pin mechanisms, locking ratchets, removable physical locks, etc.), physical barriers, visual indicators, and the like.

[0126] In some embodiments where the dock port coupling mechanism 310 includes a bayonet locking coupling mechanism, the dock port coupling mechanism 310 includes one or more features for engaging and holding the suture anchor cap 320 with the quick release dock port 304. For example, as discussed in more detail below, the dock port coupling mechanism 310e may include one or more features for axially outwardly biasing the suture anchor cap 320e relative to the quick release dock port 304e to ensure that the bayonet pin 314e remains engaged with the bayonet slot 324e.

[0127] In some embodiments, and as shown at least in FIGS. 10A-10C, 15A-15G, and 15I-15M, the suture anchor cap 320 includes gripping features 328 configured to facilitate gripping the suture anchor cap 320 and transitioning the quick release suture mechanism 302 between a locked configuration and an unlocked configuration. The gripping features 328 may include any suitable features, including, but not limited to, textured surfaces, depressions, protrusions, knobs, levers, handles, tabs, and the like, and / or may be any suitable feature.

[0128] In particular, FIGS. 10A-10C show an embodiment in which the gripping features 328c include a set of ridges to facilitate loosening the suture anchor cap 320 from the quick release dock port 304. In the embodiments of FIGS. 15A-15G and 15I-15M, the gripping features 328e include tabs configured to facilitate actuating the bayonet locking mechanism of the dock port coupling mechanism 310e.

[0129] The suture anchor cap 320 can have any of a variety of structures and / or configurations. In some embodiments, and as shown in FIG. 7, the suture anchor cap 320 includes an inner plug 332 that is at least partially received within the quick release dock port 304 when the quick release suture mechanism 302 is in a locked configuration. The suture anchor cap 320 can further include an outer skirt 334 that circumferentially surrounds the inner plug 332 and extends circumferentially around the quick release dock port 304 when the quick release suture mechanism 302 is in a locked configuration. In such embodiments, the suture anchor cap 320 can further 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 dock port 304 when the quick release suture mechanism 302 is in a locked configuration.

[0130] In embodiments where the dock port coupling mechanism 310 includes a threaded coupling, as shown in FIGS. 8-9, the inner surface of the outer skirt 334 can include and / or define a cap thread 322, and the outer surface of the quick release dock port 304 can include and / or define a port thread 312. In other embodiments, the inner plug 332 can include and / or define a cap thread 322, and the inner surface of the quick release dock port 304 can include and / or define a port thread 312.

[0131] The suture anchor cap 320 can be configured to be operably coupled to the release suture 236 in any of a variety of manners. In particular, in various embodiments, the release suture 236 extends between and terminates at a suture anchor end 237 and a suture free end 238, and the suture anchor cap 320 includes a suture anchor location 326 configured such that the suture anchor end 237 is coupled thereto. Specifically, the suture anchor cap 320 is configured to be operably coupled to the suture anchor end 237 at the suture anchor location 326 such that the suture anchor end 237 is restricted from being removed from the suture anchor cap 320 during operation of the quick release suture mechanism 302 (e.g., when the quick release suture mechanism 302 is in either a locked configuration or an unlocked configuration).

[0132] In some embodiments, the suture anchor end 237 is fixedly coupled to the suture anchor location 326 via an adhesive, cement, mechanical coupling, tied knot, mechanical obstruction (e.g., between a knot in the release suture 236 and a smaller opening in the suture anchor cap 320), and / or other means for fixedly coupling the suture anchor end 237 to the suture anchor location 326.

[0133] As used herein, the suture anchor end 237, and / or the suture free end 238, may refer to each respective end portion of the release suture 236, or may refer to each respective portion of the release suture 236 that extends proximate to these end portions. Thus, for example, the suture anchor end 237, and / or the suture free end 238, may be described as being coupled to another component when an area of the release suture 236 proximate to such end portions is coupled to the other component.

[0134] The quick release suture mechanism 302 is generally configured such that the free end 238 of the suture is fixed in place when the quick release suture mechanism 302 is in the locked configuration. In particular, when the quick release suture mechanism 302 is in the locked configuration, the free end 238 of the suture is fixed at least substantially in a predetermined position relative to the quick release dock port 304. Such a configuration can operate to prevent the release suture 236 from being removed from the quick release suture mechanism 302 or the implantable device before the quick release suture mechanism 302 is shifted to the unlocked configuration.

[0135] Alternatively, when the quick release suture mechanism 302 is in the unlocked configuration, the free end 238 of the suture moves freely through the quick release dock 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 pulling the entire release suture 236 out of the suture locking assembly 300, forming the delivery device 100, and / or pulling it out of the implantable device.

[0136] The quick release suture mechanism 302 can be configured to engage the free end 238 of the suture in any suitable manner when the quick release suture mechanism 302 is in the locked configuration. For example, as shown in FIG. 7, when the quick release suture mechanism 302 is in the locked configuration, the free end 238 of the suture can be interposed between the quick release dock port 304 and the suture anchor cap 320. As a more specific example, the free end 238 of the suture may be sandwiched between the quick release dock port 304 and the inner plug 332 and / or between the quick release dock port 304 and the outer skirt 334.

[0137] As a more specific example, such as the embodiment of FIG. 8, when the quick release suture mechanism 302 is in a locked configuration, the free end 238 of the suture is configured to extend between the port thread 312 and the cap thread 322. Thus, in such an embodiment, the free end 238 of the suture can be locked in place via a threaded engagement between the port thread 312 and the cap thread 322.

[0138] In some embodiments (see, e.g., FIGS. 7-10D), the suture anchor cap 320 defines an inner bore 330 that extends at least partially through the suture anchor cap 320. In particular, FIGS. 7-9 show embodiments where the inner bore 330 extends completely through the length of the suture anchor cap 320, while FIGS. 10A-10D show embodiments where the inner bore 330 extends only partially through the suture anchor cap 320. In some embodiments, the inner plug 332 defines at least a portion of the inner bore 330.

[0139] In some embodiments, the suture anchor end 237 and / or the free end 238 of the suture can extend at least partially through the inner bore 330. In some embodiments (see, e.g., FIGS. 7-9), the inner bore 330 can include a suture anchor location 326. For example, the suture anchor end 237 can be fixedly coupled to the suture anchor cap 320 at a location on the inner surface of the suture anchor cap 320 that defines the inner bore 330 (e.g., via an adhesive, cement, and / or any other suitable joining means). Additionally or alternatively, and as described in more detail below, the inner bore 330 can include one or more geometric features (e.g., constriction, bend, etc.) that function as the suture anchor location 326 by at least partially restricting the removal of the release suture 236 from the inner bore 330.

[0140] In some embodiments, as shown in FIGS. 7-8, the quick release suture mechanism 302 is configured such that when the quick release suture mechanism 302 is in a locked configuration, the free end 238 of the suture extends at least substantially outside the inner bore 330. In particular, in some such embodiments, the free end 238 of the suture extends from the suture exit port 354, through the quick release dock port 304, around the outer surface of the inner plug 332, and through the annular channel 336, such that the free end 238 of the suture extends away from the interface between the suture anchor cap 320 and the quick release dock port 304. Thus, in such embodiments, a portion of the free end 238 of the suture may enter the inner bore 330, but the free end 238 of the suture need not be configured to be accessed through the inner bore 330 when the quick release suture mechanism 302 is in a locked configuration.

[0141] In other embodiments, the quick release suture mechanism 302 may be configured such that when the quick release suture mechanism 302 is in a locked configuration, the free end 238 of the suture extends at least partially through the inner bore 330. For example, as shown in FIG. 9, the free end 238 of the suture extends from the suture exit port 354, through the inner bore 330, around the outer skirt 334, and into the annular channel 336 around the end of the quick release dock port 304, and may extend back through the inner bore 330.

[0142] Alternatively, the free end 238 of the suture may extend from the suture exit port 354, around the end of the quick release dock port 304 via the annular channel 336, around the outer skirt 334, and through the inner bore 330.

[0143] In each of these embodiments, similar to the embodiment of FIG. 8, the free end 238 of the suture may be confined between the port thread 312 and the cap thread 322 when the quick release suture mechanism 302 is in a locked configuration.

[0144] In some embodiments, the suture anchor cap 320 may define a plurality of inner holes 330. For example, as shown in FIGS. 15I - 15K, the inner hole 330 may be a first inner hole 330, and the suture anchor cap 320 may further include a second inner hole 331. In such embodiments, the suture anchor end 237 may extend at least partially through the first inner hole 330, and / or the suture free end 238 may extend at least partially through the second inner hole 331 (e.g., when the quick release suture mechanism is in the locked configuration).

[0145] Each of the suture anchor end 237 and the suture free end 238 may be operably coupled to the suture anchor cap 320 in any of a variety of manners. For example, as shown in FIG. 15J, the suture anchor end 237 may extend through a first inner hole 330e and terminate in a knot. In this way, the knotted end of the suture anchor end 237 may fit within the recess of the suture anchor location 326e, although it may be too large to pass through the first inner hole 330e.

[0146] As another example, and as shown in FIG. 15K, the suture anchor end 237 may extend through a first inner hole 330e and may continue around the outside of an inner plug 332e that is tied to and / or otherwise secured to a portion of the release suture 236 to secure the suture anchor end 237 to the suture anchor cap 320e.

[0147] In other embodiments, the suture anchor end 237 may be additionally or alternatively fixed to the suture anchor location 326, the first inner hole 330, and / or the suture anchor cap 320 (e.g., with an adhesive, with a screw, etc.).

[0148] The free end 238 of the suture can also be fixedly positioned relative to the suture anchor cap 320 in any of a variety of manners. In the embodiments of FIGS. 15A - 15M, as shown in FIGS. 15E, and 15J - 15M, the dock port coupling mechanism 310e includes a pair of bayonet pins 314e, at least one of which terminates in a pin cap 315e that is wider in diameter than the remainder of the bayonet pin 314e. In some embodiments, for example, as shown in FIGS. 15J - 15M, the free end 238 of the suture may be wound around the bayonet pin 314e such that the pin cap 315e restricts the free end 238 of the suture from falling off the end of the bayonet pin 314e. In other words, in such embodiments, the pin cap 315e may operate to hold the release suture 236 on the bayonet pin 314e. However, this is not required in all embodiments, and furthermore, it is within the scope of the present disclosure that the free end 238 of the suture can be sufficiently held on the bayonet pin 314e in the absence of, and / or without engaging, the pin cap 315e.

[0149] Additionally, or alternatively, as shown in FIGS. 15E, and 15J - 15M, at least one bayonet pin 314e may include a transverse pin hole 317e that extends through the diameter of the bayonet pin 314e. In such embodiments, and as shown in FIGS. 15J - 15K, the release suture 236, and / or its free end 238, may extend through the transverse pin hole 317e to at least partially hold the free end 238 of the suture in a predetermined position relative to the bayonet pin 314e.

[0150] Additionally, or alternatively, in some embodiments, the free end 238 of the suture may be wound around each of a pair of bayonet pins 314e. For example, the free end 238 of the suture may be wound around the first bayonet pin 314e, around the end of the quick release dock port 304e, or around the second bayonet pin 314e. In such embodiments, the free end 238 of the suture may be wound around the quick release dock port 304e and the bayonet pins 314e in the pattern of FIG. 8. Further, within the scope of the present disclosure, the free end 238 of the suture may be wound around one or more components of the quick release suture mechanism 302 using any other suitable pattern or configuration to achieve the desired suture holding strength.

[0151] In some embodiments, and as shown in FIGS. 15J - 15L, when the quick release suture mechanism 302e is in the locked configuration, the free end 238 of the release suture 236 may extend through the second inner hole 331e, through the annular channel 336e, and be wound around the bayonet pin 314e. In some such embodiments, the engagement between the free end 238 of the suture and one or both of the bayonet pin 314e and the bayonet slot 324e may be sufficient to maintain the free end 238 of the suture in a predetermined position while the quick release suture mechanism 302e is in the locked configuration.

[0152] In other embodiments, and as shown in FIG. 15M, when the quick release suture mechanism 302e is in the locked configuration, the suture free end 238 of the release suture 236 may extend through the inner hole 331e and through the annular channel 336e (as shown in FIGS. 15J-15K), extend outside the outer skirt 334e, loop around the outer skirt 334e, and return to the bayonet pin 314e. The suture free end 238 may further extend through the annular channel 336e between the outer skirt 334e and the quick release dock port 304e. In this way, the suture free end 238 may be sandwiched between the outer skirt 334e and the quick release dock port 304e and / or tension may be applied between the end of the outer skirt 334e and the bayonet pin 314e to further secure the suture free end 238 to the bayonet pin 314e.

[0153] In some embodiments, the suture free end 238 may be fixedly coupled to the suture anchor cap 320, additionally or alternatively, at least when the quick release suture mechanism 302 is in the locked configuration and / or may remain attached to the suture anchor cap 320 when the suture anchor cap 320 is removed from the quick release dock port 304. In such embodiments, the release suture 236 may be removed from the suture locking assembly 300 / 400 and / or the delivery device 200 by cutting the release suture 236 after removing the suture anchor cap 320 from the quick release dock port 304. Thus, in such embodiments, the unlocking configuration of the quick release suture mechanism 302 may correspond to a configuration in which the suture anchor cap 320 is removed from the quick release dock port 304 and the suture free end 238 is subsequently removed from the suture anchor cap 320.

[0154] In other embodiments, the quick release suture mechanism 302e of FIGS. 15A-15I can be used such that the free end 238 of the suture does not extend through the second inner hole 331e and / or is not directly coupled to the suture anchor cap 320e as described above. For example, the free end 238 of the suture can be coupled (e.g., wrapped around) to the bayonet pin 314e of the quick release dock port 304, at least when the quick release suture mechanism 302e is in the locked configuration, additionally or alternatively. Thus, in such embodiments, the quick release suture mechanism 302e can be transitioned from the locked configuration to the unlocked configuration by first decoupling (e.g., unwrapping) the free end 238 of the suture from the bayonet pin 314e.

[0155] In some embodiments, as shown in FIG. 7, the quick release suture mechanism 302 includes a gasket 316 configured to form at least a substantially fluid-tight seal to limit leakage from the quick release dock port 304. In particular, in some embodiments, the gasket 316 is configured to form a substantially fluid-tight seal between the suture anchor cap 320 and the quick release dock port 304 when the quick release suture mechanism 302 is in the locked configuration. In some embodiments, the gasket 316 can be positioned within the suture exit port 354 and / or within the quick release dock port 304.

[0156] Additionally, or alternatively, in some embodiments, gasket 316 may be configured to limit fluid from exiting quick release dock port 304 when quick release suture mechanism 302 is in a released configuration. That is, when suture anchor cap 320 is removed from quick release dock port 304, quick release dock port 304 may form a leakage path from delivery device 200. To mitigate this, gasket 316 may operate to limit and / or prevent blood, saline, and / or other fluid from exiting quick release dock port 304 when suture anchor cap 320 is removed.

[0157] In some embodiments, gasket 316 may include, and / or be, a gasket that opens when compressed, such as a gasket commonly used in needleless valves. In such embodiments, gasket 316 may be open to fluid flow when suture anchor cap 320 is operably coupled to quick release dock port 304, and gasket 316 may be near fluid flow when suture anchor cap 320 is removed from quick release dock port 304.

[0158] As another example, gasket 316 may include, and / or be, a Tuohy Borst gasket that compresses and closes when suture anchor cap 320 is operably coupled to quick release dock port 304 and slightly opens when suture anchor cap 320 is removed from quick release dock port 304. In such embodiments, the slight opening of gasket 316 may facilitate pulling release suture 236 through gasket 316.

[0159] In an embodiment where the dock port coupling mechanism 310 includes a bayonet pin 314 and a bayonet slot 324, the gasket 316 can additionally operate to assist in holding the quick release suture mechanism 302 in a locked configuration. For example, when the quick release suture mechanism 302e is in the locked configuration, as shown in FIG. 15E, the suture anchor cap 320e causes the gasket 316e to be axially outwardly biased against the suture anchor cap 320e, thereby slightly compressing the gasket 316e so as to bias the bayonet pin 314e into engagement with the bayonet slot 324e. In other words, when the quick release suture mechanism 302e is in the locked configuration, the gasket 316e can axially outwardly bias the suture anchor cap 320e to maintain the engagement between the bayonet pin 314e and the bayonet slot 324e. In this way, the gasket 316e can also introduce a two-step removal mechanism into the quick release suture mechanism 302e by requiring the user to axially inwardly push the suture anchor cap 320e against the outward force of the gasket 316e before rotating the suture anchor cap 320e relative to the quick release dock port 304e.

[0160] Additionally, as shown in FIGS. 15J - 15M, in an embodiment where the suture free end 238 of the release suture 236 is wound around the bayonet pin 314e, the action of the gasket 316e to bias the bayonet pin 314e into engagement with the bayonet slot 324e can also function to sandwich the release suture 236 between the bayonet pin 314e and the bayonet slot 324e. In this way, the action of the gasket 316e to engage the bayonet pin 314e with the bayonet slot 324e can function to fix the suture free end 238 of the release suture 236 in a predetermined position while the quick release suture mechanism 302e is in the locked configuration.

[0161] Additionally, or alternatively, in some embodiments, as shown in FIGS. 15L - 15M, a portion of the bayonet slot 324e may extend towards the quick release dock port 304e to define a recess for receiving the bayonet pin 314e (e.g., when the quick release suture mechanism 302e is in the locked configuration). Thus, in such embodiments, the suture anchor cap 320e may be axially inwardly pressed against the gasket 316e before rotation, and then it may be necessary to remove the suture anchor cap 320e from the quick release dock port 304e.

[0162] In some embodiments, as shown in FIG. 7, the quick release suture mechanism 302 further includes one or more suture centralizers 358 configured to guide the release suture 236 through the tensioner housing 350. For example, if present, each suture centralizer engages the tensioner housing 350 (e.g., within the suture inlet port 352 or within the suture outlet port 354) and is configured to support the release suture 236 through a central hole or its passageway to maintain at least a portion of the release suture 236 spaced from the inner surface of the tensioner housing 350. In some embodiments, the gasket 316 may operate as a suture centralizer.

[0163] As further shown in FIG. 7, the suture locking assembly 300 may further include a flushing port 360 fluidly coupled to the suture inlet port 352 for supplying flush fluid to the tensioner housing 350 and / or a downstream portion of the delivery device 200. In some such embodiments, the tensioner housing 350 at least partially defines the flushing port 360. In particular, the quick release suture mechanism 302 enables the release suture 236 to be removed from the implantable device without removing the suture locking assembly 300 from the delivery device connection 306, so that the flush fluid can be delivered to the delivery device 200 through the tensioner housing 350 without loss of hemostasis.

[0164] If present, the flushing port 360 may include, and / or be, any suitable port, and / or coupling, such as a port that is nominally sealed and opens when another component (e.g., a flush fluid source) is operably coupled to the flushing port 360. In some embodiments, the flushing port 360 may include, and / or be, a luer lock port, and / or a swappable luer lock port.

[0165] Figures 10A - 10D sequentially illustrate an exemplary process by which the release suture 236 can be withdrawn from the quick release suture mechanism 302c. In particular, Figure 10A shows the suture anchor cap 320c operably coupled to the quick release dock port 304c such that the quick release suture mechanism 302c is in a locked configuration.

[0166] Figure 10B shows the suture anchor cap 320c removed from the quick release dock port 304c such that the quick release suture mechanism 302c is in an unlocked configuration. As shown in Figure 10B, the suture anchor end 237 is fixedly coupled to the suture anchor cap 320c within the inner bore 330, and the suture free end 238 extends from the quick release dock port 304c.

[0167] Pulling the suture anchor cap 320c from the quick release dock port 304c (e.g., to the configuration of Figure 10C) with the suture free end 238 released from the interface between the suture anchor cap 320c and the quick release dock port 304c pulls the suture free end 238 toward the quick release dock port 304c and toward the implantable device. As the suture anchor cap 320c is further pulled, the suture free end 238 can be completely withdrawn from the implantable device and the quick release dock port 304c, as shown in Figure 10D.

[0168] The foregoing description of the suture anchor cap 320 generally relates to embodiments in which the suture locking assembly 216 / 300 includes a spool 278 / 340 for applying tension to the release suture 236, but this is not essential for all embodiments. For example, FIG. 11 shows an embodiment of a suture locking assembly 400 that engages a release suture 236 attached to an implantable device (e.g., docking device 70) and selectively applies tension thereto. The suture anchor cap 320 can also be used with other delivery assemblies in which the implantable device is removably coupled to the delivery device with one or more sutures. For example, as discussed above, the suture anchor cap 320 can be used with the docking device delivery device 50 and / or the artificial valve delivery device 60 that lack a mechanism for adjusting the degree of slack in the release suture 236.

[0169] The suture locking assembly 400 may include any features, characteristics, attributes, etc. disclosed herein with reference to the suture locking assembly 216 and / or the suture locking assembly 300, and vice versa. In particular, FIG. 11 shows an embodiment in which the suture locking assembly 400 includes the quick release suture mechanism 302 described above with reference to FIGS. 7-10D.

[0170] The present disclosure generally relates to embodiments in which the suture locking assembly 400 is used with a release suture 236, but this is not required, and furthermore, it is within the scope of the present disclosure that the suture locking assembly 400 can be used with any suitable suture. For example, the suture locking assembly 400 can be used with sutures that are not configured to be coupled to and / or released from an implantable device. Thus, as used herein, the release suture 236 can additionally or alternatively be referred to as the suture 236.

[0171] As shown in FIG. 11, the suture locking assembly 400 includes a tensioner housing 450 that at least partially receives a suture tensioner 402. The tensioner housing 450 includes a suture inlet port 452 such that a release suture 236 extends between the implantable device and the suture tensioner 402 via the suture inlet port 452. In some embodiments, as shown in FIG. 11, the tensioner housing 450 further includes a suture outlet port 454 such that the release suture 236 extends through the tensioner housing 450 between the suture inlet port 452 and the suture outlet port 454.

[0172] As shown in FIG. 11, the suture locking assembly 400, and / or the suture inlet port 452, can be configured to be operably coupled to the delivery device connection 306 of the delivery device 200. Thus, the suture locking 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 connection 306. As an example, the delivery device connection 306 can represent a portion of a branch 244 of the adapter 240, as shown in FIG. 6B.

[0173] FIGS. 12A-15M show more specific examples of the suture locking assembly 400, and / or its components, as described in more detail below. In particular, FIGS. 12A-12G illustrate a first exemplary suture locking assembly 400a, FIG. 13 illustrates a second exemplary suture locking assembly 400b, FIGS. 14A-14B show a third exemplary suture locking assembly 400c incorporating a fourth exemplary quick release suture mechanism 302d, and FIGS. 15A-15M show a fourth exemplary suture locking assembly 400d incorporating a fifth exemplary quick release suture mechanism 302e. Generally, it can be understood that the features, characteristics, attributes, etc. of the suture locking assembly 400 disclosed herein with reference to FIG. 11 also apply to any of the suture locking assemblies 400a / 400b / 400c / 400d, and vice versa.

[0174] Returning to FIG. 11, the suture tensioner 402 of the suture locking 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 posts 430 coupled to each other via a connection body 420 (e.g., an arm, hub, disk, wheel, etc.) such that as the suture tensioner 402 rotates, the post 430 rotates integrally about the tensioner central axis 404. In some embodiments, the post 430 and / or the connection body 420 may collectively be referred to as a fork-shaped tensioner mechanism.

[0175] When the suture tensioner 402 rotates in a first direction (e.g., counterclockwise in the embodiment of FIG. 11) relative to the tensioner housing 450, the post 430 engages and collects (e.g., winds up) the length of the release suture 236, selectively increasing the length of the release suture 236 surrounded by the tensioner housing 450, thereby selectively increasing the tension of the release suture 236. In some embodiments, the suture locking assembly 400 may be configured such that the release suture 236 extends from the suture tensioner 402 through the suture inlet port 452 to the implantable device and back to the suture tensioner 402 via the suture inlet port 452. Thus, in such embodiments, rotating the suture tensioner 402 in the first direction to increase the length of the release suture 236 housed within the tensioner housing 450 operates to increase the tension of the release suture 236 between the suture tensioner 402 and the implantable device.

[0176] After rotating the suture tensioner 402 in a first direction, and with the release suture 236 under tension, rotating the suture tensioner 402 in a second direction opposite the first direction (e.g., clockwise in the embodiment of FIG. 11) operates to gradually release the tension of the release suture 236. As the suture tensioner 402 rotates in the second direction, the release of tension can allow slack to form within the release suture 236. For example, if the tension applied by the suture tensioner 402 is released and no external tension acts to pull the release suture 236 from the tensioner housing 450 through the suture inlet port 452, the slack release suture 236 can remain within the tensioner housing 450. As discussed in more detail below, the spaced configuration of the post 430 can allow the slack release suture 236 to occupy the tensioner housing 450 and / or resume a tensioned configuration with minimal risk of entanglement.

[0177] In some embodiments, as shown in FIG. 11 and discussed in more detail below, the suture locking assembly 400 and / or the suture tensioner 402 are configured to be utilized with the quick release suture mechanism 302 and / or the suture anchor cap 320 disclosed herein. In particular, in some such embodiments, the quick release suture mechanism 302 is coupled to and / or incorporated into the suture outlet port 454. In such embodiments, the suture locking assembly 400 can be described as being similar and / or equivalent to an embodiment of the suture locking assembly 300 where the spool 340 is replaced with the suture tensioner 402, as described herein.

[0178] However, in other embodiments, the suture locking assembly 400, and / or the suture tensioner 402, may not be configured to be utilized with the quick release suture mechanism 302, and / or the suture anchor cap 320. In particular, in some embodiments, the tensioner housing 450 may lack the 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 a first end and a second end and may terminate at the first end and the second end, at least one of which is fixedly coupled to each suture anchor location 440 of the suture tensioner 402. As shown in FIG. 11, at least one of the posts 430 may include, and / or may define, such suture anchor locations 440.

[0179] Each of the posts 430 may have any suitable shape and / or configuration for engaging the release suture 236, as described herein. In some embodiments, as shown in FIGS. 11-12G, 14A, and 15D-15H, each post 430 is substantially cylindrical having a circular cross-sectional shape.

[0180] However, this is not required for all embodiments, and in addition, it is within the scope of the present disclosure for each post 430 to have any of a variety of shapes. As an example, as illustrated in FIG. 13 and described in more detail below, each post 430 may have an asymmetric shape, such as a male-female shape.

[0181] As a further example, 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.

[0182] Furthermore, while the present disclosure generally relates to embodiments in which the posts 430 are at least substantially identical to each other (e.g., in shape and / or size), it is also within the scope of the present disclosure for a pair of posts 430 to differ in shape and / or size.

[0183] FIG. 11 shows a configuration in which the suture tensioner 402 applies tension to the release suture 236, while FIGS. 12A - 12G show a series of events in which the suture tensioner 402a increases the tension in the release suture 236 and then releases this tension.

[0184] The suture tensioner 402 may be described as transitioning between a plurality of tensioner configurations to selectively apply tension to the release suture 236. For example, rotating the suture tensioner 402 relative to the tensioner housing 450 may operate to transition the suture tensioner 402 between a plurality of tensioner configurations defined between and including a release configuration and a full - tension configuration.

[0185] In the release configuration, the post 430 is positioned so as not to apply (or to apply a negligible) force to the release suture 236. For example, when the suture tensioner 402 is in the release configuration, as shown in FIG. 12A, one or both of the posts 430 may be spaced from or in contact with a straight line connecting the suture inlet port 452 and the suture outlet port 454. In particular, FIG. 12A shows a configuration in which the release suture 236 extends between the suture inlet port 452a and the suture outlet port 454a and each post 430 is spaced from the release suture 236.

[0186] In various embodiments, 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 from the straight line connecting the suture inlet port 452 and the suture outlet port 454 may be described as representing the release configuration.

[0187] Looking at the configuration shown in FIGS. 12A - 12E continuously, it can be seen that rotating the suture tensioner 402a with respect to the tensioner housing 450a (counterclockwise in this embodiment) operates to engage the post 430a with the release suture 236. As the suture tensioner 402a continues to rotate, the post 430a encompasses the increase in the length of the release suture 236 such that the length of the release suture 236 extending between the suture inlet port 452a and the suture outlet port 454a increases. This can operate to increase the tension in the release suture 236, such as when the distal portion of the release suture 236 is coupled to a transplantable device that is axially fixed relative to the suture locking assembly 400. FIG. 12E represents the full - tension configuration of the suture tensioner 402a, and the post 430a is positioned to engage the release suture and provide maximum tension to the release suture 236 when the release suture 236 is coupled to the transplantable device.

[0188] FIGS. 12E - 12G show a series of events starting from the full - tension configuration where the suture tensioner 402a rotates (clockwise in this embodiment) with respect to the tensioner housing 450a to decrease the tension in the release suture 236. In particular, when the distal end of the release suture 236 is coupled to a transplantable device that does not experience a distally - directed force, rotating the suture tensioner 402a from the full - tension configuration of FIG. 12E towards the release configuration of FIG. 12G allows slack to develop within the release suture 236.

[0189] As shown in FIGS. 12F-12G, since the posts 430a that operate to apply tension to 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 in a state with a low risk of entanglement. Specifically, in this embodiment, the release suture 236 does not experience a distally directed force (i.e., directed out of the tensioner housing 450a through the suture inlet port 452a), so the length of the release suture 236 housed within the tensioner housing 450a remains substantially unchanged as the tension applied by the suture tensioner 402a is released.

[0190] As shown in FIG. 12G, the spaced-apart posts 430a can expand a sufficient volume of the release suture 236 without becoming entangled with itself. In particular, as shown in FIGS. 11-13, the tensioner housing 450 can include and / or define a tensioner chamber 422 that surrounds 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 can freely occupy the region of the tensioner chamber 422 between the posts 430 without being obstructed by the suture tensioner 402. In other words, the suture locking 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).

[0191] In contrast to a suture locking assembly that applies tension to a release suture using a spool, the spaced-apart posts 430 of the suture locking assembly 400 can provide a greater ability to increase the length of the release suture 236 within the tensioner housing 450 per rotation of the suture tensioner 402. For example, rotating a spool (e.g., spool 278, or spool 340) through half a rotation collects a length of the release suture 236 approximately equal to half around the spool. In contrast, as shown compared to FIGS. 12A - 12E (discussed in more detail below), rotating the suture tensioner 402 through half a rotation can collect a length of the release suture 236 approximately equal to approximately twice the distance separating the posts 430.

[0192] Further, the spaced-apart posts 430 of the suture tensioner 402 can provide enhanced stability, and / or safety of the release suture 236 when the suture tensioner 402 is in a full-tension configuration relative to a suture locking assembly that utilizes a spool. For example, referring to the suture locking assembly 300 of FIG. 7, when the spool 340 operates to apply tension to the release suture 236, the release suture 236 applies torque to the spool 340 with a magnitude equal to the product of the tension of the release suture 236 and the radius of the spool 340. In contrast, referring to FIG. 12E, when the suture tensioner 402a is in a full-tension configuration, the release suture 236 can be at least substantially aligned with the post 430a such that the release suture 236 applies minimal torque to the suture tensioner 402a. Thus, less force, and / or mechanical resistance may be required compared to a configuration that applies tension to the release suture 236 using a spool (e.g., spool 278, or spool 340) to maintain the suture tensioner 402a in a full-tension configuration (e.g., to counter the pull of the release suture 236).

[0193] As discussed above with reference to FIGS. 12A-12G, the suture tensioner 402 may be described as being in a release configuration when the suture tensioner 402 is in any of a variety of rotational configurations where the post 430 does not block and / or apply tension to the release suture 236. For example, as shown in FIG. 12G, the spaced-apart posts 430a may be positioned in any of a variety of rotational configurations corresponding to the release configuration while having clearance.

[0194] Similarly, the full tension 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 that maximizes the length of the release suture 236 that the post 430 extends within the tensioner housing 450.

[0195] As shown in FIGS. 12A-12G, the suture tensioner 402 rotates relative to the tensioner housing 450 at an angle of about 180 degrees to shift the suture tensioner 402 between the release configuration and the full tension configuration. However, this is not required for all embodiments, and in addition, it is within the scope of the present disclosure that the suture tensioner 402 may rotate at any suitable angle to shift between the release configuration and the full tension configuration. By way of example, the suture tensioner 402 may be configured to rotate relative to the tensioner housing 450 at an angle less than 180 degrees, about 180 degrees, greater than 180 degrees, less than 360 degrees, about 360 degrees, and / or greater than 360 degrees.

[0196] In some embodiments, the suture locking assembly 400 may include one or more features that mechanically limit the range of rotational movement of the suture tensioner 402 and / or define a release configuration and / or a full tension configuration. For example, as shown in FIG. 11, the suture locking assembly 400 may include one or more rotator stops 442 that are fixed in a predetermined position relative to the tensioner housing 450. In some embodiments, at least one rotator stop 442 extends into the tensioner chamber 422 and engages one or both of the posts 430 when the suture tensioner 402 is in the release configuration and / or the full tension configuration to define the release configuration and / or the full tension configuration.

[0197] Additionally or alternatively, at least one rotator stop 442 may be positioned outside of the tensioner chamber 422 and / or positioned to engage the rotator 410 that rotates the suture tensioner 402 (discussed in more detail below). For example, the rotator 410 may include a rotator stop 442 in the form of a component that mates with a corresponding component of the tensioner housing 450 to define the release configuration and / or the full tension configuration. In some embodiments, using a single rotator stop 442 may allow the suture tensioner 402 to rotate through approximately and / or substantially a full rotation before being mechanically limited by the rotator stop 442. Examples of the rotator 410 are shown as the rotator 410c in FIGS. 14A - 14B and the rotator 410d in FIGS. 15A - 15C and 15E - 15H, and thus references herein to the rotator 410 may be understood to relate to the rotator 410c, the rotator 410d, and / or any other embodiments of the rotator described herein.

[0198] Each post 430 can be configured to engage the release suture 236 in any suitable manner. As shown in FIG. 11, each post 430 can be described as including a suture engagement surface 432 that engages the release suture 236 during operative use of the suture locking assembly 400 (e.g., while the suture tensioner 402 is operating to apply tension to the release suture 236).

[0199] In some embodiments, each suture engagement surface 432 is the outer surface of each post 430 and / or is otherwise fixed relative to the remainder of each post 430 and / or relative to the connection body 420. Thus, in such embodiments, the suture tensioner 402 can be configured such that the release suture 236 slides relative to each suture engagement surface 432 as the suture tensioner 402 rotates relative to the tensioner housing 450. That is, in embodiments where each suture engagement surface 432 has an orientation fixed relative to the connection body 420, by rotating the suture tensioner 402 about the tensioner central axis 404, each suture engagement surface 432 rotates about the tensioner central axis 404 and rotates about an axis parallel to the tensioner central axis. Thus, such movement can slide the release suture 236 relative to each suture engagement surface 432 as the post 430 moves to engage the release suture 236.

[0200] In other embodiments, the suture tensioner 402 can be configured such that the release suture 236 remains in at least substantially static contact with each suture engagement surface 432 as the suture tensioner 402 rotates. As an example and as shown in FIG. 11, the suture tensioner 402 may include a pair of rollers 438, each rotatably coupled to a respective post 430 and each including a respective suture engagement surface 432. For example, each roller 438 may circumferentially surround a respective post 430 and / or may be rotatably coupled to a respective post 430, such as via a bearing.

[0201] As another example, each post 430 may be rotatably coupled to the connection body 420. In particular, each post 430 may define respective suture engagement surfaces 432, and the entire post 430 (or at least substantially the entire post) may be configured to rotate relative to the connection body 420.

[0202] In such embodiments, each suture engagement surface 432 may be rotated relative to the connection body 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 embodiments, the static friction between the release suture 236 and each suture engagement surface 432 may rotate each suture engagement surface 432 relative to the connection body 420 and / or relative to each respective post 430 as the suture tensioner 402 rotates. Accordingly, such a configuration may facilitate increasing or decreasing the tension of the release suture 236 by rotating the suture tensioner 402 without the post 430 pulling or pushing on the release suture 236 due to sliding friction between the release suture 236 and the suture engagement surface 432.

[0203] In embodiments where each post 430 is circular, the size (e.g., diameter) of each post 430 may be selected based on any of a variety of considerations. For example, a larger circular post 430 may function to increase the minimum radius of curvature of the release suture 236 within the suture locking assembly 400, which may function to avoid local stresses within the release suture 236. Additionally, a larger circular post 430 may accommodate an increase in the length of the release suture 236 wound by the post 430 as the suture tensioner 402 transitions from the release configuration to the full tension configuration. Alternatively, a smaller circular post 430 may provide a wide area corresponding between the posts 430 for the release suture 236 to expand when the release suture 236 is slackened.

[0204] As described above, Figure 13 shows an embodiment in which each post 430b has an asymmetric male-female shape. Figure 13 may also be described as representing an embodiment in which each post 430 has a width that is greater at the leading edge 434b than at the trailing edge 436b (e.g., measured along a direction perpendicular to and intersecting the tensioner central axis 404b).

[0205] Referring to the embodiment of Figure 13, each post 430b may be described as including a leading edge 434b and a trailing edge 436b such that each suture engagement surface 432b extends between the leading edge 434b and the trailing edge 436b of each post 430b. In particular, compared to the circular posts 430a of Figures 12A - 12G, the male-female shape of the post 430c of Figure 13 may result in an extended suture engagement surface 432c without significantly reducing the open space between the posts 430c. Such a configuration may function to distribute the force of each post 430c over a greater range of the length of the release suture 236, which may facilitate applying tension to the release suture 236 with the suture tensioner 402c. Additionally, or alternatively, such a configuration may function to increase the minimum radius of curvature of the release suture 236 within the suture locking assembly 400c (e.g., relative to the suture locking assembly 400b of Figures 12A - 12G), which may function to avoid local tension within the release suture 236. Further, such a configuration may function to increase the length of the release suture 236 wound by the male-female shaped post 430c per rotation of the suture tensioner 402 compared to a configuration that utilizes circular posts 430.

[0206] Figures 14A - 14B show a third exemplary suture locking assembly 400c with a suture tensioner 402a in combination with a fourth exemplary quick release suture mechanism 302. In the embodiment of Figures 14A - 14B, the suture locking assembly 400c is configured such that the tensioner housing 450c extends adjacent to a portion of the delivery device 200a. In particular, Figures 14A - 14B show embodiments in which the tensioner housing 450c extends adjacent to and / or is a component of the hub assembly 218a of the delivery device 200a that at least partially surrounds the sleeve shaft 220a and the pusher shaft 212a. The hub assembly 218a (in conjunction with the suture locking assembly 400c) can be used to independently control the pusher shaft 212a and the sleeve shaft 220a, while the sleeve handle 224a can control the axial position of the sleeve shaft 220 relative to the pusher shaft 212.

[0207] As shown in FIGS. 14A - 15C and 15E - 15H, the suture locking assembly 400 can include a rotator 410 configured to be manually actuated by a user to rotate the suture tensioner 402 relative to the tensioner housing 450. In some embodiments, and as shown in FIGS. 14A and 15E - 15H, the rotator 410 is fixedly coupled to each of the posts 430 and / or is integrally formed with the posts 430. Similarly, in some embodiments, the rotator 410 may be fixedly coupled to the connection body 420 and / or may include and / or define the connection body 420. In particular, in the embodiment of FIGS. 15E - 15H, the rotator 410d, the connection body 420d, and the post 430d are integrally formed as a monolithic component such that the rotator 410d extends outside the tensioner housing 450d and the connection body 420d and the post 430d extend inside the tensioner housing 450d. As shown in FIG. 15G, the connection body 420d may also include a bottom plate on the opposite side of the rotator 410d that restricts the release suture 236 from falling off the post 430d. In this way, the connection body 420d can be described as operating to hold the release suture 236 within the tensioner housing 450d.

[0208] In some embodiments, 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 such 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.

[0209] As a more specific example, FIG. 14A shows an embodiment in which the rotator 410c includes a plurality of locking tabs 418c configured to restrict the rotator 410c from being removed from the tensioner housing 450c.

[0210] As another example, FIGS. 15E - 15G show an embodiment in which the tensioner housing 450d includes a plurality of locking tabs 456d configured to limit removal of the rotator 410d from the tensioner housing 450d.

[0211] Thus, in such embodiments, the rotator 410, connection body 420, and post 430 can be integrally formed (e.g., molded) as a monolithic component that is easily assembled into the tensioner housing 450 by inserting these components into the tensioner housing 450 until locking tabs (e.g., locking tab 418c or locking tab 456d) engage and hold the rotator 410 and / or the tensioner housing 450. After the rotator 410, connection body 420, and / or post 430 are fully inserted into the tensioner housing 450 in this manner, the locking tabs 418 and / or locking tabs 456 can function to limit and / or prevent disassembly of the suture locking assembly 400.

[0212] In various embodiments, the rotator 410 can include one or more features to facilitate gripping the rotator 410 and / or rotating the suture tensioner 402 to a desired tension configuration. For example, in the embodiments of FIGS. 15A - 15C and 15G - 15H, the rotator 410d includes a gripping portion 412d configured to facilitate gripping the rotator 410d and manually rotating the suture tensioner 402d relative to the tensioner housing 450d. In the embodiments of FIGS. 15A - 15C and 15G - 15H, the gripping portion 412d includes a plurality of depressions circumferentially distributed around the circumference of the rotator 410d. In other embodiments, the gripping portion 412 can alternatively or additionally include any suitable gripping feature and / or be any suitable gripping feature, examples of which include a textured surface, indentation, protrusion, knob, lever, handle, tab, etc.

[0213] In some embodiments, 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 shows an embodiment in which the suture locking assembly 400c includes an indicator 416c configured to provide a visual indication of the tensioner configuration. In the embodiment of FIG. 14B, each of the rotator 410c and the tensioner housing 450c includes a portion of the indicator 416c. Specifically, in this embodiment, the indicator 416c includes a mark on the tensioner housing 450c and a pair of circumferentially spaced marks on the rotator 410c. Thus, each mark on the rotator 410c can be aligned with the mark on the tensioner housing 450c when the suture tensioner 402 is in the release configuration or the full tension configuration. In other embodiments, the indicator 416 may include any additional or alternative visual indicators, and / or may consist of, including marks, printed marks, embossed marks, debossed marks, numerical scales, and the like.

[0214] Additionally, or alternatively, in some embodiments, the suture locking assembly 300, and / or the suture locking assembly 400, may include one or more features for selectively restricting access to the quick release suture mechanism 302. In particular, as shown by the dashed line in FIG. 14B, the suture locking assembly 400c may include a safety handle 414c operatively coupled to the rotator 410c and extending away from the rotator 410c. Specifically, when the rotator 410c is in a predetermined rotational orientation relative to the tensioner housing 450c, such as the full tension configuration, the safety handle 414c may cover the quick release suture mechanism 302d and obstruct and / or prevent manual access to the quick release suture mechanism 302d.

[0215] In particular, it may be desirable to ensure that the quick release suture mechanism 302 remains in the locked configuration while the suture tensioner 402 is in the full tension configuration. Thus, if present, the safety handle 414 (e.g., safety handle 414c of FIG. 14B) can reduce the likelihood of inadvertently removing the suture anchor cap 320 from the quick release dock port 304 before releasing the tension on the release suture 236. In such embodiments, rotating the rotator 410 to move the suture tensioner 402 toward and / or to the release configuration (such as by gripping and rotating the safety handle 414) can operate to move the safety handle 414 away from the quick release suture mechanism 302, thereby enabling access to the suture anchor cap 320.

[0216] In some embodiments, the suture locking assembly 400 may include one or more features for restricting and / or preventing unintentional rotation of the rotator 410 relative to the tensioner chamber 422. For example, the suture locking assembly 400 may include a direction selector, such as a mechanism similar to the direction selector 274 of FIGS. 6B-6C, that allows the rotator 410 to rotate in only one direction, preventing rotation in the wrong direction. In some embodiments, the direction selector may include a ratchet mechanism, such as a switchable ratchet mechanism, that allows the user to select the desired direction of rotation. In particular, the direction selector may allow the user to toggle such a switchable ratchet mechanism between a first mode in which the rotator 410 is rotatable to increase the tension on the release suture 236 and is prevented from rotating to decrease the tension on the release suture 236, and a second mode in which the rotator 410 is rotatable to decrease the tension on the release suture 236. In some such embodiments, the rotator is prevented from rotating to increase the tension on the release suture 236 when in the second mode.

[0217] As another example (see FIGS. 15F-15G), the suture locking assembly 400d may include a rotator locking mechanism 490d configured to limit the rotator 410d from rotating away from one or more predetermined configurations (e.g., a full tension configuration). In particular, in this example, the rotator 410d includes a rotator locking channel 424d accessible from below the rotator 410d, and the rotator receiver 482d includes a rotator locking protrusion 428d extending into the rotator locking channel 424d. To illustrate this configuration, FIG. 15F is a cross-sectional view of the suture locking assembly 400 taken through a plane intersecting the rotator 410d at the top of the rotator locking channel 424d. The rotator locking mechanism 490d may be described as including the rotator locking channel 424d and the rotator locking protrusion 428d.

[0218] Referring to FIG. 15F, rotating the rotator 410d relative to the tensioner housing 482d operates to move the rotator locking channel 424d relative to the rotator locking protrusion 428d, thereby repositioning the rotator locking protrusion 428d within the rotator locking channel 424d. The rotator 410d may further include a detent 426d that serves to increase the radius of the rotator locking channel 424d (e.g., relative to the tensioner central axis 404d) and thereby 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 locking protrusion 428d engages the detent 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 locking protrusion 428d away from the tensioner central axis 404d and / or deflect the detent 426d toward the tensioner central axis 404d.

[0219] Additionally, and as shown in FIG. 15F, the rotator locking channel 424d may include a locking projection receiver 425d in which the rotator locking projection 428d may be received when the rotator 410d is rotated to a position corresponding to the full tension configuration. The locking projection receiver 425 may be partially defined by a detent 426d such that the rotator 410d is restricted from rotating to release the tension of the suture thread unless sufficient torque is applied to the rotator 410d to move the detent 426d past the rotator locking projection 428d when the suture tensioner 402d is in the full tension configuration.

[0220] In the embodiment of FIG. 15F, the rotator locking mechanism 490d includes a single detent 426d that partially defines a single corresponding locking projection receiver 425d, which in turn corresponds to a single predetermined configuration (e.g., full tension configuration) of the suture locking assembly 400d. In other embodiments, the rotator locking mechanism 490d may operate to define a plurality of such predetermined configurations, such as corresponding to a release configuration, or a partially tensioned configuration, of the suture locking assembly 400d. For example, such a rotator locking mechanism 490d may include a plurality of detents 426d, and / or a plurality of locking projection receivers 425d.

[0221] Additionally or alternatively, the rotator locking mechanism 490d may include any of a variety of other components or mechanisms for defining one or more predetermined configurations of the suture locking assembly 400d. For example, the rotator locking projection 428 may be biased radially inwards or outwards and configured to be received within a groove, notch, etc. that extends radially inwards or outwards from the rotator locking channel 424d when the rotator 410d is rotated to a position corresponding to a predetermined configuration of the suture locking assembly 400d.

[0222] In some embodiments, as shown in FIGS. 11 and 15D - 15G, the suture locking assembly 400 further comprises one or more suture centralizers 458 configured to guide the release suture 236 through the tensioner housing 450. For example, if present, each suture centralizer engages the tensioner housing 450 (e.g., within the suture inlet port 452 or within the suture outlet port 454) and supports the release suture 236 through its central bore to maintain at least a portion of the release suture 236 spaced from the inner surface of the tensioner housing 450.

[0223] As further shown in FIGS. 11 and 14A - 15G, the suture locking assembly 400 may further include a flushing port 460 fluidly coupled to the suture inlet port 452 for supplying flushing fluid to the tensioner housing 450 and / or a downstream portion of the delivery device 200. Specifically, the flushing port 460 may be fluidly coupled to the suture inlet port 452 via the tensioner chamber 422. In some such embodiments, the tensioner housing 450 at least partially defines the flushing port 460. In the embodiments of FIGS. 15A - 15G, the quick release suture mechanism 302e allows the release suture 236 to be removed from the implantable device without removing the suture locking assembly 400d from the delivery device connection 306 (shown in FIG. 11), such that the flushing fluid can be delivered to the delivery device 200 via the tensioner housing 450 without loss of hemostasis.

[0224] If present, the flushing port 460 may include any suitable port and / or connection, such as a port that is nominally sealed and opens when another component (e.g., a flushing fluid source) is operably coupled to the flushing port 460, and / or vice versa. In some embodiments, the flushing port 460 may include a luer - lock port and / or a swappable luer - lock port, and / or vice versa.

[0225] As described above, the suture locking assembly 400d of FIGS. 15A-15M represents an example that includes an example of the quick release suture mechanism 302 (i.e., the quick release suture mechanism 302e). In the example of FIGS. 15A-15M, the suture tensioner 402d and the quick release suture mechanism 302e are coupled to each other by a suture locking assembly housing 470d.

[0226] As shown in FIG. 15D, the suture locking assembly housing 470d includes a first conduit 484d and a second conduit 486d that branches from the first conduit 484d. Specifically, the first conduit may completely penetrate the suture locking assembly housing 470d and may be configured to receive a component of the delivery device, such as the sleeve shaft 220 of the delivery device 200. The second conduit 486d is connected to the suture tensioner 402d such that the release suture 236 extends through the second conduit 486d to the suture tensioner 402d. In this way, the first conduit 484d and the second conduit 486d may each be similar to the straight section 242 and the branch 244 of the adapter 240 of FIG. 6B.

[0227] In the example of FIGS. 15A-15M, the suture locking assembly housing 407d includes an inner housing 480d and an outer housing 472d that at least substantially surrounds 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 that are configured to be assembled to each other on opposite sides of the inner housing 480d to at least substantially surround the inner housing 480d.

[0228] In the embodiments of FIGS. 15A - 15M, the inner housing 480d comprises and / or defines a rotator receiver 482d that receives each of the first conduit 484d and the second conduit 486d, as well as at least a portion of the suture tensioner 402d. In particular, as shown in FIGS. 15E - 15G, the rotator receiver 482d defines a locking tab 456d.

[0229] In certain embodiments, the seal may be included within the suture locking assembly 400 by using, for example, one or more annular sealing elements (e.g., O - rings) 258 to prevent leakage of blood, saline, or other fluids through the system. For example, as shown in FIGS. 14A and 15E, the suture locking assembly 400c / 400d may include O - rings 258c / 258d configured to form a seal between the rotator 410c / 410d and the tensioner housing 450c / 450d. Additionally, or alternatively, the suture locking assembly 300 / 400 may include one or more O - rings 258 configured to seal the release suture pathway when the suture locking assembly 300 / 400 is assembled, enabling hemostasis when connected to a properly sealed delivery device.

[0230] Any system, device, apparatus, etc. herein can be sterilized (e.g., using heat / thermal, pressure, steam, radiation, and / or chemicals, etc.) to ensure safe use on a patient, and any method herein can include sterilizing the associated system, device, apparatus, etc. as one of the steps of the method. Examples of sterilization by heat / thermal include sterilization by steam and sterilization by autoclave. Examples of radiation used for sterilization include, but are not limited to, gamma rays, ultraviolet rays, and electron beams. Examples of chemicals used for sterilization include, but are not limited to, ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde, and glutaraldehyde. Sterilization by hydrogen peroxide may be performed, for example, using hydrogen peroxide plasma.

[0231] Additional Examples Related to the Disclosed Technology In view of the above-described disclosed implementations, this application discloses the additional examples listed below. It should be noted that one or more features of an isolated example, or a combination thereof, and optionally two or more features of that example in combination with one or more features of one or more additional examples are also further examples that fall within the disclosure of this application.

[0232] Example 1. A quick-release suture mechanism comprising a suture anchor cap configured to selectively couple to and decouple from a quick-release dock port, the quick-release suture mechanism being configured to couple to a suture configured to be connected to an implantable device, the quick-release suture mechanism being configured to selectively transition between a locking configuration in which the quick-release suture mechanism maintains the suture in a fixed position relative to the quick-release dock port and an unlocking configuration in which the suture can be removed from the quick-release dock port, wherein when the suture anchor cap is operably coupled to the quick-release dock port, the quick-release suture mechanism is in the locking configuration, and when the suture anchor cap is removed from the quick-release dock port, the quick-release suture mechanism is in the unlocking configuration.

[0233] Example 2. The quick-release suture mechanism according to any of the examples described herein, particularly Example 1, wherein the quick-release suture mechanism is configured to couple to a suture locking assembly having a tensioner housing, the quick-release suture mechanism comprising a quick-release dock port, and the quick-release dock port is configured to be attached to a suture exit port of the tensioner housing.

[0234] Example 3. During operation of the quick release suture mechanism, the suture extends from the quick release dock port through the suture exit port, through the suture inlet port of the suture locking assembly, to the implantable device, and then back to the quick release dock port via the suture inlet port and the suture exit port, in any of the embodiments described herein, particularly the quick release suture mechanism described in Example 2.

[0235] Example 4. The quick release suture mechanism is configured to be coupled to a suture locking assembly comprising a tensioner housing and a spool configured to engage the suture, the tensioner housing at least partially receiving the spool, and the spool being rotatable relative to the tensioner housing when the quick release suture mechanism is in a locked configuration to wind a portion of the suture around the spool and increase the tension of the suture between the suture locking assembly and the implantable device, in any of the embodiments described herein, particularly the quick release suture mechanism described in any one of Examples 1-3.

[0236] Example 5. Further comprising a quick release dock port and a dock port coupling mechanism configured to selectively couple a suture anchor cap to the quick release dock port, wherein one or both of the suture anchor cap and the quick release dock port comprise at least a portion of the dock port coupling mechanism, in any of the embodiments described herein, particularly the quick release suture mechanism described in any one of Examples 1-4.

[0237] Example 6. The dock port coupling mechanism comprises a port thread of the quick release dock port and a cap thread of the suture anchor cap, the cap thread being configured to engage threadedly with the port thread to selectively couple the suture anchor cap to the quick release dock port, in any of the embodiments described herein, particularly the quick release suture mechanism described in Example 5.

[0238] Example 7. The docking port coupling mechanism is of a bayonet locking configuration and comprises a bayonet pin and a bayonet slot configured to receive the bayonet pin. One of the quick release docking port and the suture anchor cap comprises the bayonet pin, and the other of the quick release docking port and the suture anchor cap comprises the bayonet slot. The quick release suture mechanism according to any one of the embodiments described herein, particularly the quick release suture mechanism according to any one of Embodiments 5 to 6.

[0239] Example 8. The bayonet pin comprises a pin cap having a diameter wider than the remaining portion of the bayonet pin and terminating with the pin cap. The suture extends between and terminates at each of the suture anchor end and the suture free end. The quick release suture mechanism is configured such that the suture free end can be wound around the bayonet pin so that the pin cap holds the suture on the bayonet pin. The quick release suture mechanism according to any one of the embodiments described herein, particularly the quick release suture mechanism according to Example 7.

[0240] Example 9. The bayonet pin comprises a transverse pin hole extending through the diameter of the bayonet pin. The quick release suture mechanism is configured such that the suture extends through the transverse pin hole to at least partially hold the suture against the bayonet pin. The quick release suture mechanism according to any one of the embodiments described herein, particularly the quick release suture mechanism according to any one of Embodiments 7 to 8.

[0241] Example 10. The suture anchor cap comprises an inner plug, an outer skirt circumferentially surrounding the inner plug, and an annular channel defined between the outer skirt and the inner plug. 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 such that the inner plug is received within the quick release docking port and the outer skirt extends circumferentially around the quick release docking port. The quick release suture mechanism according to any one of the embodiments described herein, particularly the quick release suture mechanism according to any one of Embodiments 1 to 9.

[0242] Example 11. A suture extends between and terminates at each of a suture anchor end and a suture free end, and a suture anchor cap includes a suture anchor position, and the suture anchor cap is configured to be operably coupled to the suture anchor end at the suture anchor position, such that the suture anchor end is restricted from being removed from the suture anchor cap during operative use of the quick release suture mechanism, of any of the embodiments described herein, particularly the quick release suture mechanism described in any one of Embodiments 1-10.

[0243] Example 12. A quick release suture mechanism of any of the embodiments described herein, particularly the quick release suture mechanism described in Example 11, wherein the suture anchor end is configured to be fixedly coupled to the suture anchor position.

[0244] Example 13. A quick release suture mechanism of any of the embodiments described herein, particularly the quick release suture mechanism described in any one of Embodiments 11-12, wherein the suture anchor end is configured to be operably coupled to the suture anchor position via one or more of an adhesive, a cement, a mechanical coupling, a binding coupling, and a mechanical obstruction.

[0245] Example 14. A quick release suture mechanism of any of the embodiments described herein, particularly the quick release suture mechanism described in any one of Embodiments 11-13, wherein the suture free end is configured to be at least substantially fixed in a predetermined position relative to the quick release dock port when the quick release suture mechanism is in a locked configuration, and the suture free end is configured to move freely through the quick release dock port when the quick release suture mechanism is in an unlocked configuration.

[0246] Example 15. The suture anchor cap further comprises a dock port coupling mechanism configured to selectively couple to a quick release dock port. The dock port coupling mechanism comprises a port thread of the quick release dock port and a cap thread of the suture anchor cap. The cap thread is configured to engage threadably with the port thread to selectively couple the suture anchor cap to the quick release dock port. The quick release suture mechanism is any of the examples described herein where the free end of the suture is locked in place between the port thread and the cap thread when the quick release suture mechanism is in a locked configuration, particularly any one of Examples 11 - 14 of the quick release suture mechanism described herein.

[0247] Example 16. The suture anchor cap defines an inner hole, and one or both of the suture anchor end and the free end of the suture extend at least partially through the inner hole, any of the examples described herein, particularly any one of Examples 11 - 15 of the quick release suture mechanism described herein.

[0248] Example 17. The inner hole includes the suture anchor position, any of the examples described herein, particularly the quick release suture mechanism described in Example 16.

[0249] Example 18. The suture anchor cap comprises an inner plug that defines at least a portion of the inner hole, any of the examples described herein, particularly any one of Examples 16 - 17 of the quick release suture mechanism described herein.

[0250] Example 19. The inner hole is a first inner hole, and the suture anchor cap further includes a second inner hole. The suture anchor end extends at least partially through the first inner hole, and the free end of the suture extends at least partially through the second inner hole when the quick release suture mechanism is in a locked configuration, any of the examples described herein, particularly any one of Examples 16 - 18 of the quick release suture mechanism described herein.

[0251] Example 20. A quick-release suture mechanism according to any of the examples described herein, particularly any one of Examples 11 to 19, wherein the inner hole extends completely through the length of the suture anchor cap.

[0252] Example 21. A quick-release suture mechanism according to any of the examples described herein, particularly any one of Examples 11 to 19, wherein the inner hole extends through only a portion of the length of the suture anchor cap.

[0253] Example 22. A quick-release suture mechanism according to any of the examples described herein, particularly any one of Examples 11 to 21, wherein the suture free end is configured to extend at least substantially outside the inner hole when the quick-release suture mechanism is in the locked configuration.

[0254] Example 23. The quick-release dock port is configured to be attached to the suture exit port of the tensioner housing. The suture anchor cap includes an inner plug, an outer skirt that circumferentially surrounds the inner plug, and an annular channel defined between the outer skirt and the inner plug. When the quick-release suture mechanism is in the locked configuration, the annular channel receives at least a portion of the quick-release dock port such that the inner plug is received within the quick-release dock port and the outer skirt extends circumferentially around the quick-release dock port. The quick-release suture mechanism is such that when the quick-release suture mechanism is in the locked configuration, the suture free end extends from the suture exit port through the inner hole, surrounds the outer skirt, enters the annular channel, and then passes through the inner hole again. A quick-release suture mechanism according to any of the examples described herein, particularly any one of Examples 11 to 22.

[0255] Example 24. A suture anchor cap includes gripping features configured to facilitate gripping the suture anchor cap and transitioning a quick-release suture mechanism between a locked configuration and an unlocked configuration, the quick-release suture mechanism according to any of the embodiments described herein, particularly the quick-release suture mechanism according to any one of Embodiments 1 to 23.

[0256] Example 25. The gripping features include one or more of a textured surface, a recess, a protrusion, a knob, a lever, a handle, and a tab, the quick-release suture mechanism according to any of the embodiments described herein, particularly the quick-release suture mechanism according to Example 24.

[0257] Example 26. The quick-release suture mechanism further includes a gasket configured to form at least a substantially fluid-tight seal to limit leakage from the quick-release dock port, the quick-release suture mechanism according to any of the embodiments described herein, particularly the quick-release suture mechanism according to any one of Embodiments 1 to 25.

[0258] Example 27. The quick-release suture mechanism is configured to be coupled to a suture locking assembly having a tensioner housing, and the gasket is configured to form at least a substantially fluid-tight seal between the suture anchor cap and the tensioner housing when the quick-release suture mechanism is in the locked configuration, the quick-release suture mechanism according to any of the embodiments described herein, particularly the quick-release suture mechanism according to Example 26.

[0259] Example 28. The gasket is configured to form at least a substantially fluid-tight seal to limit fluid from exiting the quick-release dock port when the quick-release suture mechanism is in the unlocked configuration, the quick-release suture mechanism according to any of the embodiments described herein, particularly the quick-release suture mechanism according to any one of Embodiments 26 to 27.

[0260] Example 29. A quick release dock port is configured to be attached to the suture outlet port of the tensioner housing, and a gasket is received within one or both of the suture outlet port and the quick release dock port, the quick release suture mechanism according to any one of the examples described herein, particularly any one of Examples 26 - 28.

[0261] Example 30. A quick release dock port is configured to be attached to the suture outlet port of the tensioner housing, and a gasket operates to maintain the suture in the central region of the suture outlet port and align the suture with the inner bore of the suture anchor cap, the quick release suture mechanism according to any one of the examples described herein, any one of Examples 26 - 29.

[0262] Example 31. Further comprising a dock port coupling mechanism configured to selectively couple the suture anchor cap to the quick release dock port, the dock port coupling mechanism comprising a bayonet pin and a bayonet slot configured to receive the bayonet pin in a bayonet locking configuration, one of the quick release dock port and the suture anchor cap comprising the bayonet pin, the other of the quick release dock port and the suture anchor cap comprising the bayonet slot, and when the quick release suture mechanism is in a locked configuration, a gasket radially outwardly biases the suture anchor cap to bias the bayonet pin into engagement with the bayonet slot, the quick release suture mechanism according to any one of the examples described herein, any one of Examples 26 - 30.

[0263] Example 32. A suture locking assembly comprising a spool configured to engage a suture configured to be connected to a transplantable device, and a quick release suture mechanism, the quick release suture mechanism being the quick release suture mechanism according to any one of Examples 1 - 31.

[0264] Example 33. The suture locking assembly according to any of the examples described herein, particularly the suture locking assembly described in Example 32, further comprising a tensioner housing that at least partially receives a spool, the tensioner housing comprising a suture inlet port and a suture outlet port, and the quick-release suture mechanism being attached to the suture outlet port.

[0265] Example 34. The suture locking assembly according to any of the examples described herein, particularly the suture locking assembly described in Example 33, wherein the tensioner housing comprises a quick-release dock port.

[0266] Example 35. The suture locking assembly according to any of the examples described herein, particularly the suture locking assembly according to any one of Examples 33 to 34, wherein the quick-release dock port and the suture outlet port are integrally formed.

[0267] Example 36. The suture locking assembly according to any of the examples described herein, particularly the suture locking assembly according to any one of Examples 33 to 35, wherein the suture locking assembly is configured such that a suture extends between a transplantable device and a spool via a suture inlet port.

[0268] Example 37. The suture locking assembly according to any of the examples described herein, particularly the suture locking assembly according to any one of Examples 33 to 36, wherein the suture locking assembly is configured such that a suture extends between a spool and a quick-release suture mechanism via a suture outlet port.

[0269] Example 38. The suture locking assembly according to any of the examples described herein, particularly the suture locking assembly according to any one of Examples 33 to 37, wherein the suture locking assembly is configured to be operably coupled to a delivery device configured to deliver a transplantable device to a target implantation site within a patient's body, and the tensioner housing is configured to be operably coupled to a delivery device connection of the delivery device such that a suture extends between a spool and a transplantable device via the delivery device connection.

[0270] Example 39. The suture locking assembly according to any one of the embodiments described herein, particularly the suture locking assembly described in Example 38, further comprising a tensioner housing that at least partially receives a spool, the tensioner housing comprising a suture inlet port and a suture outlet port, the quick release suture mechanism being attached to the suture outlet port, and the suture inlet port being configured to be operably coupled to a delivery device connection.

[0271] Example 40. The suture locking assembly according to any one of the embodiments described herein, particularly the suture locking assembly according to any one of Examples 33-39, further comprising one or more suture centralizers configured to guide the suture through the tensioner housing.

[0272] Example 41. The suture locking assembly according to any one of the embodiments described herein, particularly the suture locking assembly described in Example 40, wherein at least one suture centralizer is configured to maintain at least a portion of the suture spaced from the inner surface of the tensioner housing.

[0273] Example 42. The suture locking assembly according to any one of the embodiments described herein, particularly the suture locking assembly according to any one of Examples 40-41, wherein at least one suture centralizer engages the tensioner housing within the suture inlet port.

[0274] Example 43. The suture locking assembly according to any one of the embodiments described herein, particularly the suture locking assembly according to any one of Examples 40-42, wherein at least one suture centralizer engages the tensioner housing within the suture outlet port.

[0275] Example 44. The suture locking assembly according to any one of the embodiments described herein, particularly the suture locking assembly according to any one of Examples 33-43, wherein the spool is configured to selectively rotate relative to the tensioner housing to selectively increase the length of the suture encapsulated by the tensioner housing.

[0276] Example 45. Any of the embodiments described herein, particularly the suture locking assembly according to any one of Embodiments 33 to 44, further comprising a rotator configured to be manually actuated by a user to rotate the spool relative to the tensioner housing.

[0277] Example 46. Any of the embodiments described herein, particularly the suture locking assembly according to Example 45, wherein the rotator is fixedly coupled to the spool.

[0278] Example 47. Any of the embodiments described herein, particularly the suture locking assembly according to any one of Examples 45 to 46, wherein at least a portion of the rotator extends outside the tensioner housing.

[0279] Example 48. Any of the embodiments described herein, particularly the suture locking assembly according to any one of Examples 45 to 47, wherein the rotator comprises a gripping portion configured to facilitate manually rotating the spool relative to the tensioner housing by gripping the rotator.

[0280] Example 49. Any of the embodiments described herein, particularly the suture locking assembly according to Example 48, wherein the gripping portion comprises one or more of a textured surface, a recess, a protrusion, a knob, a lever, a handle, and a tab.

[0281] Example 50. Any of the embodiments described herein, particularly the suture locking assembly according to any one of Examples 45 to 49, further comprising a safety handle operably coupled to the rotator and extending away from the rotator, the safety handle covering the quick release suture mechanism to prevent access to the quick release suture mechanism when the rotator is in a predetermined rotational orientation relative to the tensioner housing.

[0282] Example 51. Any of the embodiments described herein, particularly the suture locking assembly according to Example 50, wherein the predetermined rotational orientation corresponds to a configuration in which the spool operates to apply tension to the suture.

[0283] Example 52. The suture locking assembly is configured such that rotating the rotator away from a predetermined rotational orientation moves the safety handle away from the quick release suture mechanism, enabling access to the suture anchor cap. The suture locking assembly according to any one of Examples 50 to 51 described herein.

[0284] Example 53. The suture locking assembly described herein, further comprising a direction selector, wherein the rotator is configured to rotate in only one direction to prevent rotation in the wrong direction. The suture locking assembly according to any one of Examples 45 to 52 described herein.

[0285] Example 54. The suture locking assembly described herein, wherein the direction selector comprises a ratchet mechanism. The suture locking assembly according to Example 53 described herein.

[0286] Example 55. The suture locking assembly described herein, wherein the direction selector is configured to toggle between a first mode in which the rotator is rotatable to increase the tension of the suture and rotation to decrease the tension of the suture is prevented, and a second mode in which the rotator is rotatable to decrease the tension of the suture and rotation to increase the tension of the suture is prevented. The suture locking assembly according to any one of Examples 53 to 54 described herein.

[0287] Example 56. The suture locking assembly described herein, further comprising a flushing port fluidly coupled to the suture inlet port. The suture locking assembly according to any one of Examples 33 to 55 described herein.

[0288] Example 57. The suture locking assembly described herein, wherein the tensioner housing at least partially defines the flushing port. The suture locking assembly according to Example 56 described herein.

[0289] Example 58. A delivery device for an artificial implant, comprising the quick-release suture mechanism according to any one of Examples 1 to 31, or the suture locking assembly according to any one of Examples 32 to 57.

[0290] Example 59. A suture locking assembly, comprising a suture tensioner configured to engage a suture and configured to be connected to a transplantable device, wherein the suture tensioner is configured to selectively rotate about a tensioner central axis to collect the length of the suture, and the suture tensioner comprises a pair of posts spaced apart from each other, each post being configured to rotate around the tensioner central axis as the suture tensioner rotates, and a connection body coupled to each of the posts.

[0291] Example 60. Further comprising a tensioner housing at least partially receiving the suture tensioner, wherein the suture tensioner is configured to rotate relative to the tensioner housing, and the tensioner housing comprises a suture inlet port through which the suture extends between the transplantable device and the suture tensioner, according to any embodiment described herein, particularly the suture locking assembly according to Example 59.

[0292] Example 61. The suture locking assembly according to any embodiment described herein, particularly the suture locking assembly according to Example 60, wherein during operation of the suture locking assembly, the suture extends from the suture tensioner through the suture inlet port to the transplantable device and back to the suture tensioner through the suture inlet port.

[0293] Example 62. The suture locking assembly according to any embodiment described herein, particularly any one of Examples 59 to 61, wherein the suture tensioner is configured to operate to wind a portion of the suture around the pair of posts to increase the tension of the suture between the suture tensioner and the transplantable device.

[0294] Example 63. A suture locking assembly according to any of the examples described herein, particularly any one of Examples 59-62, wherein at least a portion of the suture is configured to be fixedly coupled to one of the posts.

[0295] Example 64. A suture locking assembly according to any of the examples described herein, particularly any one of Examples 59-63, wherein the suture extends between and terminates at each of a first end and a second end, and one or both of the first end and the second end are fixedly coupled to the suture anchor position of the suture tensioner.

[0296] Example 65. A suture locking assembly according to any of the examples described herein, particularly the suture locking assembly according to Example 64, wherein at least one of the posts includes a suture anchor position.

[0297] Example 66. A suture locking assembly according to any of the examples described herein, particularly any one of Examples 59-65, wherein the suture tensioner is configured to be rotated to a position where the post is spaced from the suture.

[0298] Example 67. A suture locking assembly according to any of the examples described herein, particularly any one of Examples 60-66, wherein the tensioner housing further includes a suture exit port such that the suture extends through the tensioner housing between the suture inlet port and the suture exit port.

[0299] Example 68. A suture locking assembly according to any of the examples described herein, particularly any one of Examples 59-67, comprising a rotator configured to be manually actuated by a user to rotate the suture tensioner.

[0300] Example 69. A suture locking assembly according to any of the examples described herein, particularly the suture locking assembly according to Example 68, wherein the rotator is fixedly coupled to each of the posts.

[0301] Example 70. A rotator and a post integrally formed, in any of the embodiments described herein, particularly the suture locking assembly according to any one of Embodiments 68 to 69.

[0302] Example 71. A rotator fixedly coupled to a connection body, in any of the embodiments described herein, particularly the suture locking assembly according to any one of Embodiments 68 to 70.

[0303] Example 72. A rotator comprising a connection body, in any of the embodiments described herein, particularly the suture locking assembly according to any one of Embodiments 91 to 97.

[0304] Example 73. A rotator configured to facilitate manually rotating a suture tensioner by gripping the rotator, having a gripping portion, in any of the embodiments described herein, particularly the suture locking assembly according to any one of Embodiments 68 to 72.

[0305] Example 74. A gripping portion having one or more of a textured surface, a recess, a protrusion, a knob, a lever, a handle, and a tab, in any of the embodiments described herein, particularly the suture locking assembly according to Example 73.

[0306] Example 75. A rotator further comprising a direction selector configured to rotate in only one direction to prevent rotation in the wrong direction, in any of the embodiments described herein, particularly the suture locking assembly according to any one of Embodiments 68 to 74.

[0307] Example 76. A direction selector having a ratchet mechanism, in any of the embodiments described herein, particularly the suture locking assembly according to Example 75.

[0308] Example 77. The suture locking assembly according to any one of the embodiments described herein, particularly any one of embodiments 75-76, wherein the direction selector is configured to toggle between a first mode in which the rotator is rotatable to increase the tension of the suture and rotation thereof is prevented to decrease the tension of the suture, and a second mode in which the rotator is rotatable to decrease the tension of the suture and rotation thereof is prevented to increase the tension of the suture.

[0309] Example 78. The suture locking assembly according to any one of the embodiments described herein, particularly any one of embodiments 68-77, further comprising a tensioner housing that at least partially receives the suture tensioner, the suture tensioner being configured to rotate relative to the tensioner housing, and at least a portion of the rotator extending outside the tensioner housing.

[0310] Example 79. The suture locking assembly according to any one of the embodiments described herein, particularly any one of embodiments 68-78, further comprising a tensioner housing that at least partially receives the suture tensioner, the suture tensioner being configured to rotate relative to the tensioner housing, and one or both of the tensioner housing and the rotator being provided with one or more locking tabs configured to limit removal of the rotator from the tensioner housing.

[0311] Example 80. The suture locking assembly according to any one of the embodiments described herein, particularly any one of embodiments 59-79, wherein the suture tensioner is configured to rotate between a plurality of tensioner configurations defined between and including a release configuration in which the post is positioned so as not to apply force to the suture and a full tension configuration in which the post is positioned to engage the suture and provide maximum tension to the suture when the suture is connected to the implantable device.

[0312] Example 81. A suture tensioner rotates through an angle that is less than 180 degrees, about 180 degrees, greater than 180 degrees, less than 360 degrees, about 360 degrees, and greater than 360 degrees, and is configured to transition the suture tensioner between a release configuration and a full tension configuration, any of the embodiments described herein, particularly the suture locking assembly described in Example 80.

[0313] Example 82. One or more rotator stops are further provided and configured to engage a portion of a suture locking assembly configured to mechanically limit rotation of the suture tensioner to define one or both of a release configuration and a full tension configuration, any of the embodiments described herein, particularly the suture locking assembly described in any one of Examples 80 - 81.

[0314] Example 83. Further comprising a tensioner housing that at least partially receives the suture tensioner, the suture tensioner being configured to rotate relative to the tensioner housing, and one or more rotator stops being fixed in a predetermined position relative to the tensioner housing, any of the embodiments described herein, particularly the suture locking assembly described in Example 82.

[0315] Example 84. Further comprising a rotator configured to be manually actuated by a user to rotate the suture tensioner relative to the tensioner housing, and at least one of the one or more rotator stops being configured to engage the rotator to define one or both of a release configuration and a full tension configuration, any of the embodiments described herein, particularly the suture locking assembly described in Example 83.

[0316] Example 85. At least one of the one or more rotator stops is configured to engage at least one of a pair of spaced posts to define one or both of a release configuration and a full tension configuration, any of the embodiments described herein, particularly the suture locking assembly described in any one of Examples 82 - 84.

[0317] Example 86. Any of the embodiments described herein, particularly the suture locking assembly according to any one of Examples 80 to 85, further comprising an indicator configured to provide a visual indication of the tensioner configuration.

[0318] Example 87. Any of the embodiments described herein, particularly the suture locking assembly according to Example 86, further comprising a tensioner housing configured to at least partially receive a suture tensioner and a rotator configured to be manually actuated by a user to rotate the suture tensioner relative to the tensioner housing, wherein one or both of the rotator and the tensioner housing comprise at least a portion of an indicator.

[0319] Example 88. Any of the embodiments described herein, particularly the suture locking assembly according to any one of Examples 86 to 87, wherein the indicator is configured to provide an indication that the suture tensioner is in one or both of a release configuration and a full tension configuration.

[0320] Example 89. Any of the embodiments described herein, particularly the suture locking assembly according to any one of Examples 86 to 88, wherein the indicator includes one or more of a mark, a printed mark, an embossed mark, a debossed mark, a numerical scale, and a pair of visual indicators that align when the suture tensioner is in one or both of a release configuration and a full tension configuration.

[0321] Example 90. Further comprising a tensioner housing that at least partially receives a suture tensioner, the suture tensioner being configured to rotate relative to the tensioner housing, the tensioner housing comprising a suture inlet port such that the suture extends between the implantable device and the suture tensioner via the suture inlet port, the tensioner housing further comprising a suture outlet port such that the suture extends through the tensioner housing between the suture inlet port and the suture outlet port, and when the suture tensioner is in a released configuration, one or both of the posts are spaced from the straight line connecting the suture inlet port and the suture outlet port, any of the embodiments described herein, particularly the suture locking assembly according to any one of embodiments 80-89.

[0322] Example 91. Further comprising a tensioner housing that at least partially receives a suture tensioner, the suture tensioner being configured to rotate relative to the tensioner housing, the tensioner housing comprising a suture inlet port such that the suture extends between the implantable device and the suture tensioner via the suture inlet port, the tensioner housing further comprising a suture outlet port such that the suture extends through the tensioner housing between the suture inlet port and the suture outlet port, and when the suture tensioner is in a released configuration, one or both of the posts are tangents to the straight line connecting the suture inlet port and the suture outlet port, any of the embodiments described herein, particularly the suture locking assembly according to any one of embodiments 80-90.

[0323] Example 92. The suture tensioner assembly further includes a tensioner housing that at least partially receives the suture tensioner, the suture tensioner being configured to rotate relative to the tensioner housing, the tensioner housing including a tensioner chamber that surrounds at least a portion of the post and a portion of the suture, and when the suture tensioner is in the released configuration, the suture freely occupies the region of the tensioner chamber between the posts without being obstructed by a portion of the suture tensioner. The suture locking assembly according to any one of the embodiments described herein, particularly any one of embodiments 80-91.

[0324] Example 93. The suture locking assembly according to any one of the embodiments described herein, particularly any one of embodiments 59-92, further includes a rotator configured to be manually actuated by a user to rotate the suture tensioner, and a rotator locking mechanism configured to limit rotation of the rotator away from one or more predetermined configurations.

[0325] Example 94. The suture tensioner is configured to rotate between a plurality of tensioner configurations, including a released configuration in which the post is positioned so as not to apply force to the suture, and a full tension configuration in which the post is positioned to engage the suture and provide maximum tension to the suture when the suture is connected to the implantable device. The rotator locking mechanism is configured to limit rotation away from the full tension configuration. The suture locking assembly according to any one of the embodiments described herein, particularly the suture locking assembly according to Example 93.

[0326] Example 95. The suture locking assembly according to any one of the embodiments described herein, particularly any one of embodiments 93-94, further includes a tensioner housing that at least partially receives the suture tensioner, the rotator including a rotator locking channel, the tensioner housing including a rotator locking protrusion that extends into the rotator locking channel, and the rotator locking mechanism including the rotator locking channel and the rotator locking protrusion.

[0327] Example 96. Rotating the rotator relative to the tensioner housing operates to move the rotator locking channel relative to the rotator locking protrusion, for any of the embodiments described herein, particularly the suture locking assembly described in Example 95.

[0328] Example 97. The rotator has a detent to partially limit rotation of the rotator relative to the tensioner housing by increasing the radius of the rotator locking channel, for any of the embodiments described herein, particularly the suture locking assembly described in any one of Examples 95 - 96.

[0329] Example 98. The rotator locking channel has a locking protrusion receiver for receiving the rotator locking protrusion when the rotator is rotated to a position corresponding to the full - tension configuration, and the detent partially defines the locking protrusion receiver, for any of the embodiments described herein, particularly the suture locking assembly described in Example 97.

[0330] Example 99. Each post has a shape that is one or more of cylindrical, conical, and frustoconical, for any of the embodiments described herein, particularly the suture locking assembly described in any one of Examples 59 - 98.

[0331] Example 100. Each post has a cross - sectional shape that is one or more of curved, circular, oval, elliptical, and ellipsoidal, for any of the embodiments described herein, particularly the suture locking assembly described in any one of Examples 59 - 99.

[0332] Example 101. A pair of posts are at least substantially identical to each other, for any of the embodiments described herein, particularly the suture locking assembly described in any one of Examples 59 - 100.

[0333] Example 102. Each post has a suture - engaging surface for engaging the suture during operative use of the suture locking assembly, for any of the embodiments described herein, particularly the suture locking assembly described in any one of Examples 59 - 101.

[0334] Example 103. The suture tensioner is configured such that when the suture tensioner rotates, the suture slides with respect to each suture engagement surface, in any of the embodiments described herein, particularly the suture locking assembly of Example 102.

[0335] Example 104. The suture tensioner is configured such that when the suture tensioner rotates, the suture remains in static contact with each suture engagement surface, in any of the embodiments described herein, particularly the suture locking assembly according to any one of Examples 102 to 103.

[0336] Example 105. The suture tensioner includes a pair of rollers, each roller is rotatably coupled to each post, each roller has each suture engagement surface, and each roller is configured to rotate with respect to each post so as to maintain static contact between the suture and each suture engagement surface when the suture tensioner rotates, in any of the embodiments described herein, particularly the suture locking assembly according to any one of Examples 102 to 104.

[0337] Example 106. Each post has a leading edge and a trailing edge, and the suture engagement surface extends between the leading edge and the trailing edge, in any of the embodiments described herein, particularly the suture locking assembly according to any one of Examples 102 to 105.

[0338] Example 107. Each post has a width measured along a direction that is perpendicular to and intersects the tensioner central axis, and the leading edge of the post is larger than the trailing edge of the post, in any of the embodiments described herein, particularly the suture locking assembly of Example 106.

[0339] Example 108. Each post is rotatably coupled to the connection body, in any of the embodiments described herein, particularly the suture locking assembly according to any one of Examples 59 to 107.

[0340] Example 109. A suture locking assembly is configured to be operably coupled to a delivery device configured to deliver an implantable device to a target implantation site within a patient's body, and a tensioner housing is configured to be operably coupled to a delivery device connection of the delivery device such that a suture extends between a suture tensioner and the implantable device via the delivery device connection. The suture locking assembly according to any of the examples described herein, particularly any one of Examples 60 to 108.

[0341] Example 110. A suture locking assembly according to any of the examples described herein, particularly the suture locking assembly described in Example 109, wherein a suture inlet port is configured to be operably coupled to a delivery device connection.

[0342] Example 111. The suture locking assembly according to any of the examples described herein, particularly any one of Examples 60 to 110, further comprising one or more suture centralizers configured to guide a suture through a tensioner housing.

[0343] Example 112. The suture locking assembly according to any of the examples described herein, particularly the suture locking assembly described in Example 111, wherein at least one suture centralizer is configured to maintain at least a portion of the suture spaced from an inner surface of the tensioner housing.

[0344] Example 113. The suture locking assembly according to any of the examples described herein, particularly any one of Examples 111 to 112, wherein at least one suture centralizer engages the tensioner housing within a suture inlet port.

[0345] Example 114. The tensioner housing further comprises a suture outlet port such that a suture extends through the tensioner housing between the suture inlet port and the suture outlet port, and at least one suture centralizer engages the tensioner housing within the suture outlet port. The suture locking assembly according to any of the examples described herein, particularly any one of Examples 111 to 113.

[0346] Example 115. A suture locking assembly according to any of the examples described herein, particularly any one of Examples 60 to 114, further comprising a flushing port fluidly coupled to the suture inlet port.

[0347] Example 116. A suture locking assembly according to any of the examples described herein, particularly the suture locking assembly described in Example 115, wherein the tensioner housing at least partially defines the flushing port.

[0348] Example 117. A suture locking assembly according to any of the examples described herein, particularly any one of Examples 115 to 116, wherein the tensioner housing includes a tensioner chamber surrounding a portion of the suture, and the flushing port is fluidly coupled to the suture inlet port via the tensioner chamber.

[0349] Example 118. A suture locking assembly according to any of the examples described herein, particularly any one of Examples 60 to 117, wherein the tensioner housing further includes a suture outlet port such that the suture extends through the tensioner housing between the suture inlet port and the suture outlet port, and the suture locking assembly further includes a quick release suture mechanism coupled to the suture outlet port, the quick release suture mechanism being any of the quick release suture mechanisms of Examples 1 to 31.

[0350] Example 119. A suture locking assembly according to any of the examples described herein, particularly the suture locking assembly described in Example 118, further comprising a suture locking assembly housing that operably couples the suture tensioner and the quick release suture mechanism to each other.

[0351] Example 120. A suture locking assembly according to any of the examples described herein, particularly the suture locking assembly described in Example 119, wherein the suture locking assembly housing includes a first conduit configured to receive the sleeve shaft of the delivery device and a second conduit branching from the first conduit, and the suture extends to the suture tensioner via the second conduit.

[0352] Example 121. The suture locking assembly housing includes an inner housing and an outer housing that at least substantially surrounds the inner housing, and is the suture locking assembly according to any one of the embodiments described herein, particularly any one of Embodiments 119-120.

[0353] Example 122. The inner housing includes a first conduit configured to receive the sleeve shaft of the delivery device and a second conduit branching from the first conduit, and the suture extends to the suture tensioner via the second conduit. It is the suture locking assembly according to any one of the embodiments described herein, particularly the suture locking assembly according to Embodiment 121.

[0354] Example 123. The outer housing includes an upper outer housing portion and a lower outer housing portion configured to be assembled with each other on opposite sides of the inner housing to at least substantially surround the inner housing. It is the suture locking assembly according to any one of the embodiments described herein, particularly any one of Embodiments 121-122.

[0355] Example 124. The inner housing includes a rotator receiver configured to receive at least a portion of the suture tensioner, and is the suture locking assembly according to any one of the embodiments described herein, particularly any one of Embodiments 121-123.

[0356] Example 125. The suture locking assembly includes a rotator configured to be manually actuated by a user to rotate the suture tensioner, and the inner housing includes one or more locking tabs configured to limit the removal of the rotator from the rotator receiver. It is the suture locking assembly according to any one of the embodiments described herein, particularly any one of Embodiments 121-124.

[0357] Example 126. The quick release suture mechanism is sterilized, and is the quick release suture mechanism according to any one of the embodiments described herein, particularly any one of Embodiments 1-31.

[0358] Example 127. A method comprising sterilizing the quick-release suture mechanism according to any one of Examples 1 to 31.

[0359] Example 128. The suture locking assembly according to any of the examples described herein, particularly the suture locking assembly according to any one of Examples 32 to 57 and Examples 69 to 125, wherein the suture locking assembly is sterilized.

[0360] Example 129. A method comprising sterilizing the suture locking assembly according to any one of Examples 32 to 57 and Examples 59 to 125.

[0361] Example 130. The delivery device according to any of the examples described herein, particularly the delivery device according to Example 58, wherein the delivery device is sterilized.

[0362] Example 131. A method comprising sterilizing the delivery device according to Example 130.

[0363] For any implementation, the various features described herein can be combined with any one or more of the other features described in any other example, unless otherwise stated. For example, any one or more of the features of one quick-release suture mechanism can be combined with any one or more of the features of another quick-release suture mechanism. As another example, any one or more of the features of one suture locking assembly can be combined with any one or more of the features of another suture locking assembly and / or any one or more of the features of a quick-release suture mechanism. Further, any one or more of the features of one delivery device can be combined with any one or more of the features of another delivery device, one or more of the features of a suture locking assembly, and / or one or more of the features of a quick-release suture mechanism.

[0364] Considering the many possible aspects to which the principles of the present disclosure may be applied, it will be recognized that the illustrated configurations are illustrative of examples of the disclosed technology and should not be construed as limiting the scope of the present disclosure or the scope of the claims. Rather, the scope of the claimed subject matter is defined by the following claims and their equivalents.

Claims

1. A suture locking assembly (400, 400a, 400b, 400c, 400d) for a delivery device (200, 200a) for delivering an artificial implant into a patient's body, A suture tensioner (402, 402a) configured to engage with a suture (236) and to be connected to an implantable device, The suture tensioners (402, 402a) are configured to selectively rotate around a tensioner central axis (404) in order to collect the length of the suture, and the suture tensioners (402, 402a) A pair of spaced-apart posts (430, 430a, 430b, 430c, 430d), each post (430, 430a, 430b, 430c, 430d) is configured to rotate around the tensioner central axis (404) as the suture tensioner (402, 402a) rotates, A suture locking assembly (400, 400a, 400b, 400c, 400d) is provided, each of which has a connecting body (420) coupled to a post (430, 430a, 430b, 430c, 430d), and is equipped with suture tensioners (402, 402a).

2. The suture locking assembly (400, 400a, 400b, 400c, 400d) according to claim 1, wherein the suture tensioners (402, 402a) are configured to operate such that rotating the suture tensioners (402, 402a) causes a portion of the suture (236) to wrap around the pair of posts (430, 430a, 430b, 430c, 430d) in order to increase the tension of the suture (236) between the suture tensioners (402, 402a) and the implantable device.

3. A suture locking assembly (400, 400a, 400b, 400c, 400d) according to any one of claims 1 to 2, wherein the suture tensioners (402, 402a) are defined between a release configuration in which the posts (430, 430a, 430b, 430c, 430d) are positioned so as not to apply force to the suture (236) and a full tension configuration in which the posts (430, 430a, 430b, 430c, 430d) are positioned to engage the suture (236) to bring maximum tension to the suture (236) when the suture (236) is connected to the implantable device, and the suture locking assembly (400, 400a, 400b, 400c, 400d) are configured to rotate to move the suture tensioners (402, 402a) between a plurality of tensioner configurations, including those defined therein.

4. The suture locking assembly (400, 400a, 400b, 400c, 400d) according to claim 3, wherein the suture tensioners (402, 402a) are configured to rotate at an angle of approximately 180 degrees to transition between the released configuration and the fully tensioned configuration.

5. The suture locking assembly (400, 400a, 400b, 400c, 400d) according to claim 3, further comprising one or more rotary stoppers (442) configured to engage with at least one of the posts (430, 430a, 430b, 430c, 430d) to define one or both of the release configuration and the full tension configuration.

6. The suture locking assembly (400, 400a, 400b, 400c, 400d) according to claim 5, further comprising tensioner housings (450, 450a, 450c, 450d) that at least partially receive the suture tensioners (402, 402a), wherein the suture tensioners (402, 402a) are configured to rotate relative to the tensioner housings (450, 450a, 450c, 450d), and one or more rotating stoppers (442) are fixed in a predetermined position relative to the tensioner housings (450, 450a, 450c, 450d).

7. The suture locking assembly (400, 400c) according to claim 3, further comprising an indicator (416c) configured to provide a visual representation of the tensioner configuration.

8. The system further comprises tensioner housings (450, 450a, 450c, 450d) that at least partially receive the suture tensioners (402, 402a), wherein the suture tensioners (402, 402a) are configured to rotate relative to the tensioner housings (450, 450a, 450c, 450d), and the tensioner housings (450, 450a, 450c, 450d) are configured to rotate relative to the tensioner housings (450, 450a, 450c, 450d), The suture extends between the implantable device and the suture tensioner (402, 402a) via the suture inlet ports (452, 452a), The suture extends through the tensioner housing (450, 450a, 450c, 450d) between the suture inlet port (452, 452a) and the suture outlet port (454, 454a), and the suture outlet port (454, 454a), wherein the suture extends through the tensioner housing (450, 450a, 450c, 450d), When the suture tensioner (402, 402a) is in the open configuration, one or both of the posts (430, 430a, 430b, 430c, 430d) are one of the following: (i) A straight tangent line connecting the suture inlet port (452, 452a) and the suture outlet port (454, 454a), or (ii) A suture locking assembly (400, 400a, 400b, 400c, 400d) according to claim 3, spaced apart from the straight line connecting the suture inlet port (452, 452a) and the suture outlet port (454, 454a).

9. The system further comprises tensioner housings (450, 450a, 450c, 450d) that at least partially receive the suture tensioners (402, 402a), wherein the suture tensioners (402, 402a) are configured to rotate relative to the tensioner housings (450, 450a, 450c, 450d), and the tensioner housings (450, 450a, 450c, 450d) are configured to receive at least a portion of the posts (430, 430a, 430b, 430c, 430d) and the sutures A suture locking assembly (400, 400a, 400b, 400c, 400d) according to claim 3, comprising a tensioner chamber (422) surrounding a portion of the suture (236), wherein when the suture tensioners (402, 402a) are in the open configuration, the suture (236) freely occupies the area of ​​the tensioner chamber (422) between the posts (430, 430a, 430b, 430c, 430d) without being obstructed by a portion of the suture tensioners (402, 402a).

10. The suture locking assembly (400, 400a, 400b, 400c, 400d) according to claim 1, further comprising a rotator (410) configured to be manually operated by a user for rotating the suture tensioners (402, 402a), wherein the rotator (410) is fixedly coupled to the connecting body (420).

11. The suture locking assembly (400, 400d) according to claim 10, further comprising a rotator locking mechanism (490d) configured to restrict the rotator (410) from rotating away from one or more predetermined components.

12. The suture locking assembly (400, 400a, 400b, 400c, 400d) according to claim 1, further comprising tensioner housings (450, 450a, 450c, 450d) that at least partially receive the suture tensioners (402, 402a), wherein the suture tensioners (402, 402a) are configured to rotate relative to the tensioner housings (450, 450a, 450c, 450d), and the tensioner housings (450, 450a, 450c, 450d) are provided with suture inlet ports (452, 452a) such that the suture extends between the implantable device and the suture tensioners (402, 402a) via the suture inlet ports (452, 452a).

13. The suture locking assembly (400, 400a, 400b, 400c, 400d) according to claim 12, wherein the suture locking assembly (400, 400a, 400b, 400c, 400d) is configured to be operably coupled to a delivery device (200, 200a) configured to deliver the implantable device to a target implantation site in the patient's body, and the suture inlet port (452, 452a) is configured to be operably coupled to the delivery device connection (306) of the delivery device (200, 200a) such that the suture extends between the suture tensioner (402, 402a) and the implantable device via the delivery device connection (306).

14. A suture locking assembly (400, 400a, 400b, 400c, 400d) according to any one of claims 12 to 13, further comprising a flushing port (360) fluidly coupled to the suture inlet port (452, 452a), wherein the tensioner housing (450, 450a, 450c, 450d) comprises a tensioner chamber (422) surrounding a portion of the suture, and the flushing port (360) is fluidly coupled to the suture inlet port (452, 452a) via the tensioner chamber (422).

15. A tensioner housing (450, 450a, 450c, 450d) that at least partially receives the suture tensioner, wherein the suture (236) extends through the tensioner housing (450, 452a) and suture outlet ports (454, 454a) between the suture inlet ports (452, 452a) and the suture outlet ports (454, 454a), the tensioner housing (450, 450a, 450c, 450d), The suture tensioners (402, 402a) are configured to selectively rotate around the tensioner central axis (404) relative to the tensioner housings (450, 450a, 450c, 450d) in order to selectively increase the length of the suture (236) surrounded by the tensioner housings (450, 450a, 450c, 450d), Each of the pair of spaced-apart posts (430, 430a, 430b, 430c, 430d)mp is configured to rotate around the tensioner central axis (404) as the suture tensioner (402, 402a) rotates relative to the tensioner housing (450, 450a, 450c, 450d), and the tensioner housing (450, 450a, 450c, 450d) is configured such that each post rotates around the tensioner central axis (404). A quick-release suture mechanism (302, 302a, 302b, 302c, 302d, 302e) is coupled to the suture exit port (454, 454a), Furthermore, The quick-release suture mechanism (302, 302a, 302b, 302c, 302d, 302e) A quick-release dock port (304) is configured to be attached to the suture exit port (454, 454a), The system includes a suture anchor cap (320) configured to be selectively coupled to the quick-release dock port and to be released from the quick-release dock port (304), The quick-release suture mechanism (302, 302a, 302b, 302c, 302d, 302e) is configured to selectively transition between a locking configuration that maintains the suture (236) in a fixed position relative to the suture outlet port (454, 454a), and a release configuration that allows the suture (236) to be removed from the suture outlet port (454, 454a). When the suture anchor cap (320) is operably coupled to the quick-release dock port (304), the quick-release suture mechanism (302, 302a, 302b, 302c, 302d, 302e) is in the locking configuration. When the suture anchor cap (320) is removed from the quick-release dock port (304), the quick-release suture mechanism (302, 302a, 302b, 302c, 302d, 302e) is in the unlocked configuration, and the suture (236) extends between the suture anchor end (237) and the suture free end (238), and terminates therein. The suture anchor cap (320) includes the suture anchor position (326), The suture anchoring assembly (400, 400a, 400b, 400c, 400d) according to claim 1, wherein the suture anchor cap (320) is configured to be operably coupled to the suture anchor end (237) at the suture anchor position (326), thereby restricting the removal of the suture anchor end (237) from the suture anchor cap (320) during operation of the quick-release suture mechanism (302, 302a, 302b, 302c, 302d, 302e).

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