Quick release suture mechanism and suture lock assembly including the same

Abstract

Disclosed herein is a quick-release suture mechanism for a suture lock assembly. The quick-release suture mechanism can include a suture anchor cap. The quick-release suture mechanism is configured to engage a suture and is configured to selectively transition between a locked configuration in which the quick-release suture mechanism maintains the suture in a fixed position relative to a quick-release dock port and an unlocked configuration in which the suture can be removed from the quick-release dock port. The suture lock assembly can include a spool configured to engage the suture and a quick-release suture mechanism configured to couple to the suture. The quick-release suture mechanism includes a quick-release dock port, a suture anchor cap, and a dock port coupling mechanism configured to selectively couple the suture anchor cap to the quick-release dock port.

Description

Technical Field

[0001] Cross - reference to related applications This application claims the benefit of priority to U.S. Provisional Application No. 63 / 366,733, filed on June 21, 2022, which is hereby incorporated by reference in its entirety for all purposes.

[0002] The present disclosure relates to a quick - release suture mechanism for a suture lock assembly, such as can be utilized with a delivery device for delivering an artificial implant into a patient's body, and further to a suture lock assembly including the quick - release suture mechanism.

Background Art

[0003] The human heart can be affected by 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. Percutaneous and minimally invasive surgical approaches are used in various procedures to deliver an artificial medical device to locations within the body that are not easily accessible surgically or to locations within the body where access without surgery is desirable. In one specific example, an artificial heart valve can be mounted in a compressed state on the end of a delivery device and advanced through the patient's vascular system (e.g., through the femoral artery and aorta) to reach the implantation site within the heart. Thereafter, the artificial heart valve can be radially expanded to its functional size, for example, by inflating a balloon on which the artificial valve is mounted, or by driving 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 so that the artificial heart valve self - expands to its functional size.

Summary of the Invention

[0004] What is described herein is a delivery device and method for implanting an artificial heart valve. The disclosed delivery device and method can provide, for example, an improved releasable suture connection to an artificial heart valve and / or to a docking device for anchoring the artificial heart valve. Thus, the devices and methods disclosed herein can, among other things, overcome one or more deficiencies of typical artificial heart valve 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 examples, the one or more shafts include a delivery shaft configured to advance through a patient's vasculature to a implantation site and configured to hold an implantable device.

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

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

[0009] In some examples, the implantable device is coupled to the delivery device via a suture that is severable to remove the implantable device from the delivery device.

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

[0011] In some examples, the suture lock assembly includes a quick release suture mechanism configured to selectively couple to and selectively remove from the suture.

[0012] In some examples, the quick-release suture mechanism includes a quick-release dock port and a suture anchor cap configured to selectively couple to and selectively decouple from the quick-release dock port.

[0013] In some examples, the quick-release suture mechanism is configured to selectively transition between a locked configuration in which the suture mechanism maintains the suture in a fixed position relative to the quick-release dock port and an unlocked configuration in which the suture can be removed from the quick-release dock port.

[0014] In some examples, the quick-release suture mechanism is in a locked configuration when the suture anchor cap is operably coupled to the quick-release dock port and in an unlocked configuration when the suture anchor cap is removed from the quick-release dock port.

[0015] In some examples, the suture lock assembly includes a spool configured to engage the suture.

[0016] In some examples, the suture lock assembly includes a tensioner housing at least partially receiving the spool and including a suture inlet port and a suture outlet port.

[0017] In some examples, the quick-release suture mechanism is configured such that the suture can be removed from the suture outlet port when the quick-release suture mechanism is in the unlocked configuration.

[0018] In a representative example, the quick release suture mechanism includes a suture anchor cap configured to selectively couple to and selectively decouple from a quick release dock port. The quick release suture mechanism is configured to couple to a suture configured to be connected to a transplantable device. The quick release suture mechanism is configured to selectively transition between a locked configuration that maintains the suture in a fixed position relative to the quick release dock port and an unlocked configuration that allows the suture to be removed from the quick release dock port. The quick release suture mechanism is in the locked configuration when the suture anchor cap is operably coupled to the quick release dock port. The quick release suture mechanism is in the unlocked configuration when the suture anchor cap is removed from the quick release dock port.

[0019] In another representative example, the suture lock assembly includes a spool configured to engage a suture configured to be connected to an implantable device, and a quick-release suture mechanism configured to couple to the suture. The quick-release suture mechanism includes a quick-release dock port configured to be attached to a suture outlet port, a suture anchor cap configured to be selectively coupled to and selectively decoupled from the quick-release dock port, and a dock port coupling mechanism configured to selectively couple the suture anchor cap to the quick-release dock port. The quick-release suture mechanism is configured to selectively transition between a locked configuration in which the quick-release suture mechanism maintains the suture in a fixed position relative to the suture outlet port and an unlocked configuration in which the suture can be removed from the suture outlet port. The quick-release suture mechanism is in the locked configuration when the suture anchor cap is operably coupled to the quick-release dock port. The quick-release suture mechanism is in the unlocked configuration when the suture anchor cap is removed from the quick-release dock port. The dock port coupling mechanism includes a port thread of the quick-release dock port and a cap thread of the suture anchor cap. The cap thread is configured to selectively couple the suture anchor cap to the quick-release dock port by threadedly engaging the port thread.

[0020] In another representative example, the suture lock assembly includes a spool configured to engage a suture configured to be connected to an implantable device, a tensioner housing that at least partially receives the spool, the tensioner housing including a suture introduction port and a suture exit port, and a quick release suture mechanism attached to the suture exit port and configured to couple to the suture. The quick release suture mechanism includes a quick release dock port configured to be attached to the suture exit port of the tensioner housing, a suture anchor cap configured to be selectively coupled to and selectively decoupled from the quick release dock port, and a dock port coupling mechanism configured to selectively couple the suture anchor cap to the quick release dock port. The quick release suture mechanism is configured to selectively transition between a locked configuration in which the quick release suture mechanism maintains the suture in a fixed position relative to the suture exit port and an unlocked configuration in which the suture can be removed from the suture exit port. The quick release suture mechanism is in the locked configuration when the suture anchor cap is operably coupled to the quick release dock port. The quick release suture mechanism is in the unlocked configuration when the suture anchor cap is removed from the quick release dock port. The dock port coupling mechanism includes a bayonet pin and a bayonet slot configured to receive the bayonet pin in a bayonet lock configuration. One of the quick release dock port and the suture anchor cap includes the bayonet pin, and the other of the quick release dock port and the suture anchor cap includes the bayonet slot.

[0021] In some examples, the suture lock assembly includes one or more of the components described in Examples 1-58 and 116-126 below.

[0022] The various innovations in this disclosure can be used in combination or individually. This summary is provided to introduce, in a simplified form, a selection of the various concepts that will be further described in the following detailed description. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. The above and other objectives, features, and advantages of this 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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[0065] General Considerations It will be understood that the disclosed examples may be configured to deliver and implant an artificial device into any natural valve annulus of the heart (e.g., pulmonary valve annulus, mitral valve annulus, and tricuspid valve annulus), and further may be used with any of a variety of delivery approaches (e.g., retrograde, antegrade, transseptal, transventricular, transatrial, etc.).

[0066] For the purposes of this specification, specific aspects, advantages, and novel features in the examples of the present disclosure are described herein. The disclosed methods, devices, and systems should not be construed as being in any way limiting. Instead, the present disclosure is directed to all novel and non-obvious features and aspects relating to the various disclosed examples, alone, in various combinations with each other, and in various sub-combinations with each other. The methods, devices, and systems are not limited to any particular aspect, feature, or combination thereof, and also do not require the presence of any one or more particular advantages or problems to be solved. The techniques from any example can be combined with the techniques described in any one or more other examples. Considering the many possible examples to which the principles of the disclosed techniques can be applied, it will be recognized that, as illustrated, the illustrated examples are merely preferred examples and should not be construed as limiting the scope of the disclosed techniques.

[0067] The operations in some of the disclosed examples are described in a particular sequential order for presentation convenience, but it should be understood that this mode of description encompasses permutations unless a particular order is required by the specific language described below. For example, operations described sequentially may, in some cases, be permuted or may be executed simultaneously. Moreover, for simplicity, the accompanying drawings may not show various ways in which the disclosed methods may be used with other methods. Additionally, in the description, terms such as "provide" or "achieve" are sometimes used to describe the disclosed methods. These terms are high-level abstractions regarding the actual operations performed. The actual operations corresponding to these terms may vary depending on a particular implementation and would be readily recognizable to one of ordinary skill in the art.

[0068] As used in this application and the claims, the singular forms "a", "an", and "the" include the plural unless the context clearly dictates otherwise. Additionally, the term "includes" means "comprises". Further, the terms "coupled" and "connected" generally mean electrically, electromagnetically, and / or physically (e.g., mechanically or chemically) coupling or connecting and do not exclude the presence of intermediate elements between coupled or associated members unless a particular contrary language is specified.

[0069] As used herein, the term "proximal" refers to the position, orientation, or portion of a device that is closer to the user and spaced from the implantation site. As used herein, the term "distal" refers to the position, orientation, or portion of a device that is spaced 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" and "axial" refer to an axis extending in the proximal-distal direction, unless otherwise explicitly defined.

[0070] As used herein, the terms "about" and "approximately" 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.

[0071] As used herein, "e.g." means "for example" and "i.e." means "that is".

[0072] Directions and other relative references (e.g., inside, outside, upper, lower, etc.) may be used in this specification to facilitate the description of the drawings and principles, but are not intended to be limiting. For example, specific terms such as "inside", "outside", "up", "down", "internal", "external", and the like may be used. Such terms are used, when applicable, to make the description somewhat clearer when dealing with relative relationships, particularly with respect to the illustrated examples. However, such terms are not intended to mean absolute relationships, positions, or directions. For example, just by turning an object over, the "upper" part may become the "lower" part. Nevertheless, it remains the same part, and the object remains the same. As used herein, "and / or" means "and" or "or", and also means "and" and "or".

[0073] Delivery technique To implant an artificial valve into the natural aortic valve via a transfemoral delivery approach, the artificial valve is attached in a radially compressed state along the distal end portion of the delivery device. The artificial valve and the distal end portion of the delivery device are inserted into the femoral artery and advanced through the descending aorta, around the aortic arch, and through the ascending aorta. The artificial valve is positioned inside the natural aortic valve and expanded radially (e.g., by inflating a balloon, by driving one or more actuators of the delivery device, or by deploying the artificial valve from a sheath to make the artificial valve self-expanding). Alternatively, the artificial valve can be implanted inside the natural 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 natural aortic valve. Alternatively, in a transaortic procedure, the artificial valve (on the distal end portion of the delivery device) is introduced into the aorta through a surgical incision in the ascending aorta, for example, by a partial J sternotomy or a small right parasternal thoracotomy, and then advanced through the ascending aorta towards the natural aortic valve.

[0074] To implant an artificial valve inside the native mitral valve via a transseptal delivery approach, the artificial valve is attached in a radially compressed state along the distal end portion of the delivery device. The artificial valve and the distal end portion of the delivery device are inserted into the femoral vein and advanced into the inferior vena cava and through the inferior vena cava into the right atrium, across the atrial septum (through a puncture made within the atrial septum), into the left atrium, and toward the native mitral valve. Alternatively, the artificial valve can be implanted inside the native mitral 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 mitral valve.

[0075] To implant an artificial valve inside the native tricuspid valve, the artificial valve is attached in a radially compressed state along the distal end portion of the delivery device. The artificial valve and the distal end portion of the delivery device are inserted into the femoral vein and advanced into the inferior vena cava and through the inferior vena cava into the right atrium, and the artificial valve is positioned inside the native tricuspid valve. A similar approach can be used to implant an artificial valve inside the native pulmonary valve or 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.

[0076] Another delivery approach is the transatrial approach, in which case the artificial valve (on the distal end portion of the delivery device) is inserted through a chest incision and through an incision formed through the atrial wall (the atrial wall of the right atrium or left atrium) to access any of the native heart valves. Transatrial 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, in which case the artificial valve (on the distal end portion of the delivery device) is inserted through a chest incision and through an incision formed through the wall of the right ventricle (typically at or near the base of the heart) to implant the artificial valve inside the native tricuspid valve or inside the native pulmonary valve or inside the pulmonary artery.

[0077] In all delivery approaches, the delivery device can be advanced through a guidewire previously inserted into the patient's vasculature. Moreover, the disclosed delivery approaches are not intended to be limiting. Any prosthetic 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.

[0078] Examples related to the disclosed technology Figures 1-4 illustrate an exemplary transcatheter heart valve replacement procedure (e.g., mitral valve replacement procedure) using a docking device 52 and a prosthetic heart valve 62 by way of example. During the procedure, the user first uses a guide catheter 30 to form a path to the patient's native heart valve (Figure 1). Thereafter, the user uses a docking device delivery device 50 to deliver and implant the docking device 52 to the location of the patient's native heart valve (Figure 2A), and then, after implanting the docking device 52, removes the docking device delivery device 50 from the patient 10 (Figure 2B). Thereafter, the user uses a prosthetic valve delivery device 60 to implant the prosthetic heart valve 62 inside the implanted docking device 52 (Figure 3A). Thereafter, the user removes the prosthetic valve delivery device 60 from the patient 10 (Figure 3B) and further removes the guide catheter 30 (Figure 4).

[0079] Figure 1 illustrates the first step in a mitral valve replacement procedure by way of example, where a guide catheter 30 and a guidewire 40 are inserted into the blood vessel 12 of the patient 10 and are maneuvered through the blood vessel 12 and into the heart 14 of the patient 10 and further toward the native mitral valve 16. The guide catheter 30 and the guidewire 40 together can provide a path through which and along which a docking device delivery device 50 and a prosthetic valve delivery device 60 can be maneuvered to the implantation site (the native mitral valve 16 or the native mitral valve annulus).

[0080] Initially, the user may first form an incision in the patient's body to access the blood vessel 12. For example, in the example illustrated in FIG. 1, the user may form an incision in the patient's groin to access the femoral vein. Thus, in such an example, the blood vessel 12 may be the femoral vein.

[0081] After forming an incision in the blood vessel 12, the user may insert a guide catheter 30, a guide wire 40, and / or additional devices (such as an introducer device or a transseptal puncture device) through the incision into the blood vessel 12. The guide catheter 30 (which may also be referred to as an "introducer device", "introducer", or "guide sheath") is configured to facilitate the percutaneous introduction of various implant delivery devices (such as a docking device delivery apparatus 50 and an artificial valve delivery apparatus 60) into the blood vessel 12 and further through the blood vessel 12, and may extend through the blood vessel 12 into the heart 14, but may stop in front of the natural mitral valve 16. The guide catheter 30 can include a handle 32 and a shaft 34 extending distally from the handle 32. The shaft 34 can extend through the blood vessel 12 into the heart 14, while the handle 32 remains outside the patient 10's body and the user can operate the handle 32 for the purpose of operating the shaft 34 (FIG. 1).

[0082] The guide wire 40 is configured to guide a delivery device (such as the guide catheter 30, the docking device delivery apparatus 50, the artificial valve delivery apparatus 60, an additional catheter, or the like) and associated devices (such as a docking device, an artificial heart valve, and the like) to a transplantation site within the heart 14, and for this purpose, may extend entirely through the blood vessel 12 into the left atrium 18 of the heart 14 (and, in some examples, through the natural mitral valve 16 into the left ventricle of the heart 14) (FIG. 1).

[0083] In some examples, a transseptal puncture device or transseptal puncture catheter can be used to first access the left atrium 18 before inserting the guide wire 40 and guide catheter 30. For example, after forming an incision in the blood vessel 12, the user may insert the 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). Thereafter, the user can form 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. Thereafter, the user can insert and advance the guide wire 40 through the transseptal puncture device in the blood vessel 12 and further through the incision in the atrial septum 22 and into the left atrium 18. After positioning the guide wire 40 within the left atrium 18 and / or left ventricle 26, the transseptal puncture device can be removed from the patient 10. Thereafter, the user can insert the guide catheter 30 into the blood vessel 12 and advance the guide catheter 30 over the guide wire 40 and into the left atrium 18 (FIG. 1).

[0084] In some examples, before inserting the guide catheter 30 into the blood vessel 12, the introducer device can be inserted through the lumen of the guide catheter 30. In some examples, the introducer device can include a tapered end portion that protrudes from the distal tip of the guide catheter 30 and is configured to guide the guide catheter 30 through the guide wire 40 into the left atrium 18. Additionally, in some examples, the introducer device can include a proximal end portion that protrudes from the proximal end of the guide catheter 30. After the guide catheter 30 reaches the left atrium 18, the user can remove the introducer device from inside the guide catheter 30 and from the patient 10. Thus, only the guide catheter 30 and the guide wire 40 remain inside the patient 10. At this point, the guide catheter 30 is positioned to receive the implant delivery device and assist in guiding this implant delivery device into the left atrium 18, as further described below.

[0085] Figure 2A illustrates a second stage in an exemplary mitral valve replacement procedure, in which case a docking device delivery device 50 (which can also be referred to as an "implant catheter" and / or a "docking device delivery device") is used to implant a docking device 52 at the native mitral valve 16 of the patient's heart 14.

[0086] Generally, the docking device delivery device 50 includes a delivery shaft 54, a handle 56, and a push assembly 58. The delivery shaft 54 is configured to be advanced by a user through the patient's vasculature (e.g., blood vessel 12) to the implantation site (e.g., native mitral valve 16), and may be configured to hold the docking device 52 at the distal end portion 53 of the delivery shaft 54. In some examples, the distal end portion 53 of the delivery shaft 54 holds the docking device 52 in a linear delivery configuration inside.

[0087] The handle 56 of the docking device delivery apparatus 50 is for advancing the delivery shaft 54 through a patient's vasculature (e.g., blood vessel 12), and is configured to be gripped by a user and / or held in some other manner by the user outside the patient 10's body.

[0088] In some examples, the handle 56 can include one or more articulating members 57 (or rotatable knobs) configured to assist in maneuvering the delivery shaft 54 through the blood vessel 12. For example, the one or more articulating members 57 can include one or more of a knob, button, wheel, and / or other type of physically adjustable control member, which are configured to be adjusted by the user to bend, curve, twist, rotate, and / or otherwise articulate the distal end portion 53 of the delivery shaft 54 to assist in maneuvering the delivery shaft 54 inside the heart 14 through the blood vessel 12.

[0089] The push-in assembly 58 can be configured to deploy and / or implant the docking device 52 at the implantation site (e.g., native mitral valve 16). For example, the push-in assembly 58 is configured to be adjusted by the user to push the docking device 52 out from the distal end portion 53 of the delivery shaft 54. The shaft of the push-in assembly 58 can extend through the delivery shaft 54 and can be disposed adjacent to the docking device 52 inside the delivery shaft 54. In some examples, as described in more detail below, the docking device 52 can be detachably coupled to the shaft of the push-in assembly 58 via a connection mechanism of the docking device delivery apparatus 50 such that the docking device 52 can be released after being deployed at the native mitral valve 16.

[0090] Further details regarding 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 for all purposes.

[0091] Referring again to FIG. 2A, after the guide catheter 30 is positioned inside the left atrium 18, the user may 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 through the guide catheter 30 and along the guide wire 40. In some examples, the guide wire 40 can be at least partially retracted into the guide catheter 30 away from the left atrium 18. The user may 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, thereby reaching the delivery shaft 54 to the left atrium 18 as illustrated in FIG. 2A. Specifically, the user may advance the delivery shaft 54 of the docking device delivery apparatus 50 by applying a force (e.g., pushing) to the handle 56 towards the patient 10 while gripping the handle 56 of the docking device delivery apparatus 50. When advancing the delivery shaft 54 through the blood vessel 12 and the heart 14, the user may adjust one or more articulating members 57 of the handle 56 to maneuver through various bends, corners, stenoses, and / or other obstacles within the blood vessel 12 and within the heart 14.

[0092] After the delivery shaft 54 reaches the left atrium 18 and protrudes from the distal end of the guide catheter 30, the user can use the handle 56 (e.g., the articulating member 57) to position the distal end portion 53 of the delivery shaft 54 at and / or near the posterior medial commissure of the native mitral valve 16. The user may then deploy and / or implant the docking device 52 into the annulus of the native mitral valve 16 by using the shaft of the push-in assembly 58 to push the docking device 52 out of the distal end portion 53 of the delivery shaft 54.

[0093] In some examples, the docking device 52 can be constructed or formed from a shape memory material and / or include a shape memory material, such that when released from restraint by the delivery shaft 54 by being derived from the delivery shaft 54, it may return to its original preformed shape. As an example, the docking device 52 may originally be formed as a coil, such that when derived from the delivery shaft 54 and returning to its original coil configuration, it may wrap around the valve tip 24 of the native mitral valve 16.

[0094] After pushing in the ventricular portion of the docking device 52 (e.g., the portion of the docking device 52 shown in FIG. 2A and configured to be disposed inside the left ventricle 26 and / or on the ventricular side of the native mitral valve 16), the user may deploy the remainder of the docking device 52 (e.g., the atrial portion of the docking device 52) from the delivery shaft 54 inside the left atrium 18 by retracting the delivery shaft 54 in a direction away from the posterior medial commissure of the native mitral valve 16.

[0095] After deploying and implanting the docking device 52 at the native mitral valve 16, the user may disconnect the docking device delivery device 50 from the docking device 52. After the docking device 52 is disconnected from the docking device delivery device 50, the user may retract the docking device delivery device 50 from the blood vessel 12 in a direction away from the patient 10, whereby the user can deliver and implant the artificial heart valve 62 within the implanted docking device 52 at the native mitral valve 16.

[0096] Figure 2B illustrates the third stage in the mitral valve replacement procedure, where the docking device 52 is fully deployed and implanted at the location of the native mitral valve 16, and the docking device delivery apparatus 50 (including the delivery shaft 54) has been removed from the patient 10, such that only the guide wire 40 and the guide catheter 30 remain inside the patient 10. In some examples, after removing the docking device delivery apparatus, the guide wire 40 can be advanced from the guide catheter 30, through the implanted docking device 52 located at the native mitral valve 16, into the left ventricle 26 (Figure 2A). In this way, 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.

[0097] As shown in Figure 2B, the docking device 52 can include a plurality of turns (or coils) wound around the leaflets 24 of the native mitral valve 16 (within the left ventricle 26). The implanted docking device 52 has a more cylindrical shape compared to the annulus of the native mitral valve 16, thereby providing a shape that more closely matches the shape or profile of the artificial heart valve to be implanted. As a result, the docking device 52 can be more tightly fitted between the artificial heart valve and the native mitral valve 16, as further described below, thereby providing a better seal between the artificial heart valve and the native mitral valve 16.

[0098] Figure 3A illustrates the fourth stage in the mitral valve replacement procedure, where the user is using the artificial valve delivery apparatus 60 to deliver and / or implant an artificial heart valve 62 (which can also be referred to herein as a "transcatheter heart valve" or "THV", and can be abbreviated as a "replacement heart valve" and / or an "artificial mitral valve") inside the docking device 52.

[0099] As shown in FIG. 3A, the artificial valve delivery device 60 can include 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 deliver, implant, expand, and / or deploy in other ways the artificial heart valve 62 within the docking device 52 to the location of the native mitral valve 16 by extending into the patient's vasculature. The handle 66 is for advancing the delivery shaft 64 through the patient's vasculature and is configured to be gripped and / or held in other ways by the user.

[0100] In some examples, the handle 66 can include one or more articulating members 68 configured to assist in maneuvering the delivery shaft 64 through the blood vessel 12 and the heart 14. Specifically, the articulating member 68 can include one or more of a knob, a button, a wheel, and / or other types of physically adjustable control members, which are configured to be adjusted by the user to bend, curve, twist, rotate, and / or otherwise articulate the distal end portion of the delivery shaft 64 to assist in maneuvering the delivery shaft 64 through the blood vessel 12 into the left atrium 18 of the heart 14 and further into the left ventricle 26.

[0101] In some examples, the artificial valve delivery device 60 can include an expansion mechanism 65 configured to radially expand and deploy the artificial heart valve 62 at the implantation site. In some examples, as shown in FIG. 3A, the expansion mechanism 65 can include an inflatable balloon configured to inflate to radially expand the artificial heart valve 62 inside the docking device 52. The inflatable balloon can be coupled to the distal end portion of the delivery shaft 64.

[0102] In other examples, the artificial heart valve 62 can be self-expanding and can be configured to radially expand itself when a sheath or capsule covering the radially compressed artificial heart valve 62 on the distal end portion of the delivery shaft 64 is removed. In yet other examples, the artificial heart valve 62 can be mechanically expandable, and the artificial valve delivery device 60 can include one or more mechanical actuators (e.g., an expansion mechanism) configured to radially expand the artificial heart valve 62.

[0103] As shown in FIG. 3A, the artificial 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.

[0104] To maneuver the distal end portion of the delivery shaft 64 to the implantation site, the user can insert the artificial valve delivery device 60 (delivery shaft 64) through the guide catheter 30 and over the guide wire 40 and into the patient 10. The user can continue to advance the artificial valve delivery device 60 along the guide wire 40 (through the blood vessel 12) until the distal end portion of the delivery shaft 64 reaches the native mitral valve 16, as illustrated in FIG. 3A. More specifically, the user can advance the delivery shaft 64 of the artificial valve delivery device 60 by gripping the handle 66 and applying a force (e.g., pushing) to the handle 66. When advancing the delivery shaft 64 through the blood vessel 12 and the heart 14, the user can adjust one or more articulating members 68 of the handle 66 to maneuver through various bends, corners, stenotic regions, and / or other obstacles within the blood vessel 12 and within the heart 14.

[0105] The user can advance the delivery shaft 64 along the guide wire 40 until the radially compressed artificial heart valve 62 attached around the distal end portion of the delivery shaft 64 is positioned within the docking device 52 and within the native mitral valve 16. In some examples, as shown in FIG. 3A, the distal end of the delivery shaft 64 and at least a portion of the radially compressed artificial heart valve 62 can be positioned inside the left ventricle 26.

[0106] After the radially compressed artificial heart valve 62 is properly positioned inside the docking device 52 (FIG. 3A), the user can drive the expansion mechanism 65 (e.g., by inflating an inflatable balloon) by operating one or more drive mechanisms of the handle 66 of the artificial valve delivery device 60 to radially expand the artificial heart valve 62 inside the docking device 52.

[0107] FIG. 3B illustrates the fifth stage of the mitral valve replacement procedure, in which case the artificial heart valve 62 is in a radially expanded configuration and is implanted inside the docking device 52 within the native mitral valve 16. As shown in FIG. 3B, the artificial heart valve 62 is received and held inside the docking device 52. Thus, the docking device 52 aids in anchoring the artificial heart valve 62 inside the native mitral valve 16. The docking device 52 can enable a better seal between the artificial heart valve 62 and the valve leaflets 24 of the native mitral valve 16, thereby reducing paravalvular leakage around the artificial heart valve 62.

[0108] Also, as shown in FIG. 3B, after the artificial heart valve 62 is fully deployed and implanted inside the docking device 52 at the native mitral valve 16, the artificial valve delivery device 60 (including the delivery shaft 64) is removed from the patient 10, whereby only the guide wire 40 and the guide catheter 30 remain inside the patient 10.

[0109] Figure 4 illustrates the sixth stage of the mitral valve replacement procedure, where in this case, the guide wire 40 and the guide catheter 30 have already been removed from the patient 10.

[0110] Although FIGS. 1 - 4 specifically illustrate mitral valve replacement, it will be understood that the same and / or similar procedures may be utilized in replacing 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 those other heart valves.

[0111] For example, when replacing a natural tricuspid valve, the user may also be able to access the right atrium 20 via the femoral vein, but may not need to cross the atrial septum 22 and enter into the left atrium 18. Instead, the user may perform the same and / or similar docking device implantation process at the tricuspid valve while leaving the guidewire 40 within the right atrium 20. Specifically, the user may be able to extrude the docking device 52 from the delivery shaft 54 around the ventricular side of the tricuspid valve leaflets, and may release the remainder of the docking device 52 from the delivery shaft 54 within the right atrium 20, and further, may remove the delivery shaft 54 of the docking device delivery apparatus 50 from the patient 10. Thereafter, the user may be able to advance the guidewire 40 through the tricuspid valve into the right ventricle, and may perform the same and / or similar artificial heart valve implantation process at the tricuspid valve within the docking device 52. Specifically, the user may be able to advance the delivery shaft 64 of the artificial valve delivery apparatus 60 along the guidewire 40 through the patient's vasculature, such that the artificial heart valve 62 is positioned / disposed within the docking device 52 within the tricuspid valve. Thereafter, the user may be able to expand the artificial heart valve 62 within the docking device 52, and then may remove the artificial valve delivery apparatus 60 from the patient 10. In another example, when replacing the aortic valve, the user may be able to perform the same and / or similar process, but may access the aortic valve from the outflow side of the aortic valve via the femoral artery.

[0112] Furthermore, although FIGS. 1 - 4 illustrate a mitral valve replacement procedure accessing the native mitral valve 16 from the left atrium 18 through the right atrium 20 and through the femoral vein, it will be understood that the native mitral valve 16 may alternatively be accessed from the left ventricle 26. For example, the user may 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 further through the aortic valve into the left ventricle 26.

[0113] FIG. 5 illustrates a docking device 70 according to an example. The docking device 70 can be used as the docking device 52 in the artificial valve implantation procedure, for example, as described above with reference to FIGS. 1-4. As shown in FIG. 5, the docking device in the deployed configuration can receive and fix an artificial valve inside this docking device, whereby the artificial valve can be configured to be fixed at the location of the native valve annulus.

[0114] 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 a particular example, 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 transition from a substantially linear configuration (or delivery configuration) when the docking device 70 is disposed inside the delivery shaft 54 of the delivery device 50 to a helical deployment configuration after being removed from the delivery shaft 54.

[0115] The coil 72 has a proximal end 72p and a distal end 72d (which also respectively define the proximal end and the distal end of the docking device 70). When disposed inside the delivery shaft 54 (e.g., when delivering the docking device 70 into the patient's vasculature), the body of the coil 72 between the proximal end 72p and the distal end 72d forms an overall linear delivery configuration (i.e., there are no coiled or looped portions, but it can bend or curve) so as to maintain a small radial profile during movement through the patient's vasculature. After being removed from the delivery shaft 54 and deployed at the implantation location, the coil 72 can transition from the delivery configuration to a helical deployment configuration and can be wound around the native tissue adjacent to the implantation location. For example, when implanting the docking device at the location of the native valve, the coil 72 can be configured to surround the native valve leaflets of the native valve (and, if present, the chordae tendineae connecting the native valve leaflets to the adjacent papillary muscles).

[0116] The docking device 70 can be detachably coupled to the docking device delivery device 50. For example, in a particular example, the docking device 70 can be coupled to the delivery device (such as those described above) via a release suture that can be configured to be coupled to the docking device 70 and can be configured to be cut for removal.

[0117] As shown in FIG. 5, the deployed coil 72 can include a leading turn 76 (or, "leading coil"), a central region 78, and a stabilizing turn 80 (or, "stabilizing coil") about a central longitudinal axis. The central region 78 can have one or more helical turns with substantially equal inner diameters. The leading turn 76, in the illustrated example, can extend from the distal end of the central region 78 and has a diameter larger than the diameter of the central region 78. The stabilizing turn 80, in the illustrated example, can extend from the proximal end of the central region 78 and has a diameter larger than the diameter of the central region 78.

[0118] Further details regarding the docking device and its variations are described in International Application No. PCT / US2021 / 056150, which is hereby incorporated by reference in its entirety for reference.

[0119] FIG. 6A illustrates a delivery device 200 configured to implant a docking device, such as the docking device 70 (FIG. 5) or other docking devices described below, into a target implantation site within a patient, according to an example. For example, the delivery device 200 can be used as the 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".

[0120] As shown in the illustration, the delivery device 200 can include a handle assembly 202 and a delivery shaft 204 (also referred to as a “delivery sheath” or 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 driving one or more components of the delivery device 200. For example, in some instances, as shown in FIG. 6A, the handle 206 can include knobs 208, 210 that are configured to manipulate or control the deflection of the delivery device 200, such as the delivery shaft 204 and / or the sleeve shaft 220 described below.

[0121] In certain examples, the delivery device 200 can also include 224, 212 and a sleeve shaft 220, both of which can extend through the lumen of the delivery shaft 204 and can have respective proximal end portions that extend into the handle assembly 202.

[0122] As described below, the distal end portion (also referred to as the “distal section”) of the sleeve shaft 220 can be configured to cover (e.g., surround) the docking device 70 (see FIG. 5). For example, the docking device 70 can be held within the sleeve shaft 220 that is further held by the distal end portion 205 of the delivery shaft 204 when being maneuvered through a patient's vasculature.

[0123] Additionally, the distal end portion 205 of the delivery shaft 204 can be configured to be maneuverable. In one example, by rotating a knob (e.g., 208 or 210) on the handle 206, the curvature of the distal end portion 205 of the delivery shaft 204 can be adjusted such that the distal end portion 205 can be oriented at a desired angle. For example, for implanting the docking device 70 at the location of the native mitral valve, the distal end portion 205 of the delivery shaft 204 can be maneuvered within the left atrium such that at least a portion of the sleeve shaft 220 and the docking device 70 held therein can extend through the native mitral valve annulus adjacent to the posterior medial commissure.

[0124] In a particular example, the push shaft 212 and the sleeve shaft 220 can be coaxial with each other, at least within the delivery shaft 204. Additionally, the delivery shaft 204 can be configured to be axially movable relative to the sleeve shaft 220 and the push shaft 212. As further described below, the distal end of the push shaft 212 can be inserted into the lumen of the sleeve shaft 220 and can press against the proximal end of the docking device 70 held within the sleeve shaft 220.

[0125] After reaching the target implantation site, the docking device 70 can be deployed from the delivery shaft 204 by operating the push-in shaft 212 and the sleeve shaft 220 using the hub assembly 218, as further described below. For example, by pushing the push-in shaft 212 distally while holding the delivery shaft 204 in place, or by pulling the delivery shaft 204 proximally while holding the push-in shaft 212 in place, or by simultaneously pushing the push-in shaft 212 distally while pulling the delivery shaft 204 proximally, the docking device 70 can be pushed out from the distal end 204d of the delivery shaft 204, thereby enabling the docking device 70 to transition from the delivery configuration to the deployed configuration (see FIG. 5). In a particular example, the push-in shaft 212 and the sleeve shaft 220 can be driven independently of each other.

[0126] During delivery, the docking device 70 can be coupled to the delivery device 200 via a release suture (not shown in FIG. 6A) that extends through the push-in shaft 212 or via other retrieval lines that can be configured to be tied around the docking device 70 and severed for removal and that include strings, yarns, or other materials. In one specific example, the release suture can extend through the delivery device 200, for example through the lumen of the push-in shaft 212, to the suture lock assembly 216 of the delivery device 200.

[0127] The handle assembly 202 can further include a hub assembly 218 to which a suture lock assembly 216 and a sleeve handle 224 are attached. The hub assembly 218 can be configured to independently control a push-in shaft 212 and a sleeve shaft 220, while the sleeve handle 224 can control the axial position of the sleeve shaft 220 relative to the push-in shaft 212. In this way, the operation of the components disposed inside the delivery shaft 204 can be driven and controlled by the operation of the various components of the handle assembly 202. In some examples, the hub assembly 218 can be coupled to the handle 206 via a connector 226.

[0128] The handle assembly 202 can further include one or more cleaning ports (e.g., cleaning port 232 is shown in FIG. 6A) for supplying a cleaning fluid to one or more internal cavities (e.g., an annular cavity disposed between coaxial components of the delivery device 200) disposed inside the delivery device 200.

[0129] FIGS. 6B-6D illustrate in more detail aspects related to the handle assembly 202 and / or the suture lock assembly 216 in FIG. 6A. As shown, the hub assembly 218 can include a Y-shaped connector 240 (also referred to as an "adapter") having a straight section 242 (e.g., a straight conduit) and at least one branch portion 244 (e.g., a branched conduit), although in some examples, it can include more than two branch portions. In some examples, the suture lock assembly 216 can be attached to the branch portion 244, and the sleeve handle (e.g., a sleeve drive handle) 224 can be disposed at the proximal end of the straight section 242.

[0130] As shown in FIGS. 6A-6D and as introduced above, the delivery device 200 can include a suture lock assembly 216 disposed on the branch portion 244 of the hub assembly 218 of the handle assembly 202. As will be described below, an exemplary suture lock assembly 216 can include a release knob 284 that can be screwed onto the end of a Y-shaped connector 240.

[0131] As shown in FIG. 6B, the hub assembly 218 includes a cleaning port 234 configured to enable cleaning of one or more lumens within the delivery device 200, thereby enabling sterilization and / or maintenance of hemostasis within the delivery device 200.

[0132] As described above, a medical professional can deploy the docking device (e.g., docking device 70) by manipulating the position of the handle assembly 202, and can add just one additional step of retracting the sleeve by pulling back the sleeve handle 224. The sleeve shaft (e.g., sleeve shaft 220) and the pushing shaft (e.g., pushing shaft 212) can be configured to cooperate such that they can be moved together simultaneously (e.g., by moving the entire hub assembly 218 and / or Y-shaped connector 240 both forwardly and / or rearwardly) when deploying and positioning the docking device at the native valve. Additionally, the sleeve shaft and the pushing shaft can also be configured to operate independently such that the pushing shaft can hold the docking device in place when the sleeve shaft is pulled away from the docking device (e.g., by 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 docking device while pulling the sleeve handle 224 proximally to pull out the sleeve shaft). The sleeve shaft and the pushing shaft can be coaxial along a part, all, or most of the delivery device 200 to facilitate this cooperation, as described above.

[0133] As shown in FIGS. 6A-6D, the suture lock assembly 216 can include a rotor 272 (which can also be referred to as a "rotatable handle") and can increase or decrease the tension on a release suture 236 (shown in FIG. 6B) that can be connected to the docking device by extending from the suture lock assembly 216 through the branch 244 and further through the handle 222 and the delivery shaft 204.

[0134] In certain examples, the release suture 236 can be wound around the spool 278 of the suture lock assembly 216 (see, for example, FIG. 6C). The rotor 272 can be coupled to the spool 278, in which case, by rotating the rotor 272 in a given orientation, the tension on the release suture 236 that traverses the delivery device 200 can be adjusted (e.g., increased or decreased). By rotating the rotor 272 (and thus the spool 278), tension or slack can be imparted to the release suture 236 to move the docking device 70 closer to or farther from the delivery device 200, respectively. As used herein, the spool 278 may be referred to as the spindle 278.

[0135] In some examples, the rotor 272 can include one or more gripping portions or grips that increase the ease of gripping the rotor 272 without slipping (e.g., by a user's hand). For example, as shown in FIG. 3, the rotor 272 can include a gripping portion 273 disposed around the periphery of the rotor 272 and configured to be gripped by a user during rotation of the rotor 272. In some examples, the gripping portion 273 can include a plurality of protrusions to increase the driving force and ease of gripping. In some examples, the gripping portion 273 can include a material having a smaller durometer (e.g., a reduced hardness) compared to the material forming another portion of the rotor 272.

[0136] In some examples, as shown in FIG. 6B, the rotor 272 can include an indicator 275 for tracking the applied number of revolutions (or a portion thereof), which may be correlated to the degree of slack or tension of the release suture 236.

[0137] In some examples, the suture lock assembly 216 can further include an orientation control mechanism that includes an orientation selector 274 (e.g., in the form of a switch, as shown in FIGS. 6B-6C) that enables a healthcare provider or other user to select whether to increase or decrease the slack of the release suture 236 that traverses the delivery device 200. For example, the orientation selector 274 can be configured to enable a healthcare provider or other user to select an orientation (e.g., an increase or decrease in tension), whereby the rotor 272 is rotatable only in one orientation to prevent rotation in an improper orientation.

[0138] In some examples, as shown in FIG. 6C, the housing 262 of the suture lock assembly 216 can include a first icon 264 that indicates the slack position of the orientation selector 274 and a second icon 266 that indicates the tension position of the orientation selector 274.

[0139] Additional details regarding the orientation control mechanism for a suture lock assembly (such as suture lock assembly 216) are described in International Patent Application No. PCT / US2020 / 36577, the disclosure of which is incorporated herein by reference for reference purposes.

[0140] In certain examples, the suture lock assembly 216 can include a connector or connection portion for attaching the suture lock assembly 216 to a handle assembly (e.g., handle assembly 202). For example, the suture lock assembly 216 can include a release bar 282 that extends into the housing 262 of the suture lock assembly 216 and is coupled to the housing 262 (see, e.g., FIG. 6C). In some examples, the release bar 282 can be adhered to the housing 262 (e.g., via an adhesive, welding, or other detachable securing means). As shown in FIG. 6C, the release knob 284 can be disposed around a portion of the release bar 282 and adjacent to the connection portion 286 of the bottom housing 268. The release knob 284 can be configured to connect the suture lock assembly 216 to the adapter 240 of the delivery device.

[0141] As described above and as shown in FIG. 6B, the adapter 240 can include a branch portion 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 portion 244) to secure the suture lock assembly 216 to the adapter 240. In some examples, the shape, size, and / or configuration of the adapter 240 can differ from that shown in FIG. 6B and can be modified based on the delivery device configured to attach the suture lock assembly 216 (and to be used with the suture lock assembly 216).

[0142] In certain examples, 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 lock assembly 216 can be coupled to the delivery device and the suture cutting section 254 can be covered by the adapter 240 (see, e.g., FIG. 6C). In some examples, after a docking device (or other implant) is positioned at a desired location for release from the delivery device, the suture lock assembly 216 can be released from the adapter 240 by unscrewing the release knob 284 from the adapter 240, and the suture cutting section 254 can be exposed by pulling the suture lock assembly 216 proximally away from the adapter 240. In an alternative example, the suture cutting section 254 can be exposed without pulling the entire suture lock assembly 216 away from the adapter 240 by rotating the release knob 284 (e.g., moving the release knob 284 toward the housing 262).

[0143] The suture cutting section 254 can be configured such that a user or healthcare provider can cut the release suture 236 that traverses the length of the delivery device to enable decoupling of the docking device from the delivery device upon deployment at the target implantation site.

[0144] In some examples, after the release suture 236 is wound around the docking device or implant and routed through the delivery device, through the release bar 282 (including across the suture cutting section 254), and into the housing 262, the two suture ends of the release suture 236 can pass through two openings disposed within the lower end of the spool 278 and can then be tied together, thereby completing the suture loop.

[0145] As shown in FIGS. 6A and 6D, the suture lock assembly 216 includes a wash port 215 that can be used to wash one or more lumens within the delivery device, thereby reducing thrombus formation between components of the delivery device and / or maintaining hemostasis within the delivery device and / or sterilizing the delivery device. In certain cases, the wash port 215 can be configured to enable independent washing of the lumen in the event that a single wash line is blocked and / or in the event that a single wash line is not maintaining hemostasis within the delivery device. In certain cases, the wash port 215 can be an open port to allow for a constant flow through the delivery device. In a particular example, the wash port 215 can be configured as self-sealing so that the operator can introduce fluid into the delivery device as needed without requiring a constant flow rate. The wash port 215 shown in FIG. 6D, as described above, allows for connection of additional wash lines, similar to the plurality of wash ports such as the wash port 232 shown in FIG. 6A and / or the wash port 234 shown in FIG. 6B. For simplicity, although the wash port 215 is not shown in FIGS. 6B-6C, it will be understood that the suture lock assembly 216 shown in FIGS. 6B-6C can also include the wash port 215.

[0146] Further details regarding a delivery device / catheter / system (including various examples of handle assemblies) configured to deliver a docking device to a target implantation site can be found in International Application No. PCT / US2020 / 036577, U.S. Patent Publication No. 2018 / 0318079, and U.S. Patent Publication No. 2018 / 0263764, each of which is incorporated herein by reference in its entirety for reference.

[0147] As described above, after the docking device 70 is implanted at the target implantation site, the release suture 236 is decoupled from the docking device 70. In the example of FIGS. 6A-6D, this is accomplished by removing the suture lock assembly 216 from the hub assembly 218 to expose a suture cutting section 254 where the release suture 236 can be cut internally. In other examples, as described below, the suture lock assembly may be configured to remain coupled to the hub assembly 218 and / or the delivery device 200 when the release suture is removed from the docking device. As will be described in more detail below, such a device may facilitate removal of the release suture 236 from the docking device 70.

[0148] FIG. 7 schematically illustrates an example of a suture lock assembly 300 that includes a quick release suture mechanism 302 configured to facilitate release of the release suture 236 from an implantable device (such as the docking device 70). The suture lock assembly 300 may include any of the features, characteristics, attributes, etc. as disclosed herein with reference to the suture lock assembly 216, and vice versa. In particular, FIG. 7 illustrates an example where the suture lock assembly 300 includes a spool 340 (similar to or the same as the spool 278) for gathering and / or adjusting the tension of the length of the release suture 236. The suture lock assembly 300 additionally includes a tensioner housing 350 that at least partially receives the spool 340.

[0149] Figures 8-10, Figures 14A-15G, and Figures 15I-15M illustrate several additional examples of the quick release suture mechanism 302, as will be described in more detail below. In particular, Figure 8 illustrates a quick release suture mechanism 302a that forms a first example, Figure 9 illustrates a quick release suture mechanism 302b that forms a second example, and Figures 10A-10D illustrate a quick release suture mechanism 302c that forms a third example. Figures 14A-14B illustrate a quick release suture mechanism 302d that forms a fourth example, and Figures 15A-15G and Figures 15I-15M illustrate a quick release suture mechanism 302e that forms a fifth example. Generally, features, characteristics, attributes, etc. of the quick release suture mechanism 302 disclosed herein with reference to Figure 7 can also be understood to be applicable to any of the quick release suture mechanisms 302a / 302b / 302c / 302d / 302e, and vice versa.

[0150] Although the present disclosure generally relates to examples in which the suture lock assembly 300 and / or the quick release suture mechanism 302 are used with the release suture 236, this is not essential, and additionally, it is within the scope of the present disclosure that the suture lock assembly 300 and / or the quick release suture mechanism 302 can be used with any suitable suture. For example, the suture lock assembly 300 and / or the quick release suture mechanism 302 may be used with sutures that are not configured to couple to a transplantable device and / or with sutures that are not configured to release a transplantable device. Accordingly, when used herein, the release suture 236 may additionally or alternatively be referred to as the suture 236.

[0151] Moreover, while the present disclosure generally relates to examples where the quick release suture mechanism 302 is used with the suture lock assembly 300, this is not essential. For example, additionally, it is within the scope of the present disclosure that the quick release suture mechanism 302 can be used independently of the suture lock assembly or the associated suture tensioning mechanism. In particular, in some examples, the docking device delivery device 50 and / or the prosthetic valve delivery device 60 do not include a mechanism for adjusting the slack of the release suture 236, yet can still be used with the quick release suture mechanism 302 to release the release suture 236.

[0152] In the present disclosure, reference signs that include alphabetical labels (e.g., "a", "b", "c", etc.) are to be understood as identifying particular examples in the structure or component corresponding to the reference sign. Thus, it will be understood that components sharing the same name and / or the same reference sign may share any properties and / or features as disclosed herein, even if a particular such component is not specifically described and / or addressed herein. Further, it will be understood that such components sharing the same name and / or the same reference sign may share any properties and / or features in examples where such the same reference sign does not include an alphabetical label. 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, the quick release suture mechanism 302d of FIGS. 14A - 14B, and / or the quick release suture mechanism 302e of FIGS. 15A - 15G and FIGS. 15J - 15K may share any suitable properties and / or features with each other. Additionally, in the present disclosure, features and / or attributes related to multiple examples (e.g., examples indicated by reference signs each including a corresponding alphabetical label) may be presented and / or described with reference to the corresponding reference signs that do not have an alphabetical label.

[0153] The tensioner housing 350 includes a suture introduction port 352 and a suture exit port 354, whereby the release suture 236 extends into the tensioner housing 350 via the suture introduction port 352 and is led out from the tensioner housing 350 via the suture exit port 354. More specifically, the release suture 236 extends between the implantable device and the spool 340 via the suture introduction port 352, and the release suture 236 extends between the spool 340 and the quick release suture mechanism 302 via the suture exit port 354.

[0154] As shown in FIG. 7, the suture lock assembly 300 and / or the suture introduction port 352 may be configured to be operably coupled to the delivery device connection portion 306 of the delivery device 200. Accordingly, the suture lock assembly 300 may be configured such that the release suture 236 extends between the spool 340 and the implantable device via the delivery device connection portion 306. As an example, the delivery device connection portion 306 may represent a part of the branch portion 244 of the adapter 240 shown in FIG. 6B and / or may include a part of such a branch portion 244.

[0155] 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 exit port 354, and a suture anchor cap 320 configured to be 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.

[0156] 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, such as to restrict and / or prevent the release suture 236 from disengaging from the suture lock assembly 300 or from the implantable device.

[0157] 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 may be removed from the suture exit port 354 and / or from the quick-release dock port 304, such as to enable removal of the release suture 236 from the implantable device.

[0158] In this way, the quick-release dock port 304 may facilitate removal of the release suture 236 from the implantable device without removing the suture lock assembly 300 from the delivery device connection 306 and / or without cutting the release suture. That is, in contrast to a suture lock 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 maintaining the suture lock assembly 300 coupled to the delivery device connection 306.

[0159] The quick release dock port 304 may be 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 outlet port 354 may be integrally formed and / or may refer to a common (e.g., the same) component.

[0160] When the quick release suture mechanism 302 is in the locked configuration, the suture lock assembly 300 may operate substantially similar to the suture lock assembly 216 of FIGS. 6A-6D. For example, when the quick release suture mechanism 302 is in the locked configuration, by rotating the spool 340 relative to the tensioner housing 350, a portion of the release suture 236 is wound around the spool 340 to increase the tension of the release suture 236 and / or to reduce the length of the release suture 236 between the suture lock assembly 300 (and / or its suture introduction port 352) and the implantable device.

[0161] However, unlike the examples of FIGS. 6A-6D, the release suture 236 in the example of FIG. 7 does not terminate on the spool 340. Instead, it passes through each of the suture introduction port 352 and the suture outlet port 354. Specifically, in the example 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, continues to the implantable device through the suture introduction port 352, and then returns to the quick release dock port 304 via the suture introduction port 352 and via the suture outlet port 354.

[0162] The suture anchor cap 320 may be configured to operably couple to the quick release dock port 304 in any of a variety of manners. As illustrated in FIG. 7, the quick release suture mechanism 302 may 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 may include at least a portion of the dock port coupling mechanism 310.

[0163] In some examples, such as the examples 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 threadedly engage with each other to selectively couple the suture anchor cap 320 to the quick release dock port 304. Specifically, in such examples, 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 examples, the quick release suture mechanism 302 may selectively transition from a locked configuration to an unlocked configuration by threadedly disengaging 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, one rotation, or two or more rotations). FIGS. 8-10D illustrate 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 for the port thread 312 to be an internal thread and the cap thread 322 to be an external thread.

[0164] In other examples, such as the examples of FIGS. 15A-15G and FIGS. 15I-15M, the dock port coupling mechanism 310 may include and / or may be a bayonet lock coupling mechanism. Specifically, in the examples of FIGS. 15A-15G and FIGS. 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 lock configuration. In the examples of FIGS. 15A-15G and FIGS. 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 examples, 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, make the suture anchor cap 320 releasable by rotating the suture anchor cap 320 relative to the quick release dock port 304 by less than one revolution (e.g., 1 / 4 revolution, 1 / 2 revolution, etc.).

[0165] Thus, in such examples, the quick release suture mechanism 302 may selectively transition 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 in a direction away from the quick release dock port 304.

[0166] Such a two-stage removal mechanism can protect against the suture anchor cap 320 accidentally coming off the quick release dock port 304. Additional or alternative examples of mechanisms for reducing the likelihood of the suture anchor cap 320 accidentally coming off the quick release dock port 304 may include two-stage removal mechanisms (e.g., grenade pin mechanisms, locking ratchets, removable physical locks, etc.), physical barriers, visual indicators, etc.

[0167] In some examples where the dock port coupling mechanism 310 includes a bayonet lock coupling mechanism, the dock port coupling mechanism 310 includes one or more features for holding the suture anchor cap 320 in an engaged state with respect to the quick release dock port 304. For example, as will be described in more detail below, the dock port coupling mechanism 310e can include one or more features for axially outwardly biasing the suture anchor cap 320e with respect to the quick release dock port 304e to ensure that the bayonet pin 314e remains engaged with the bayonet slot 324e.

[0168] In some examples, at least as illustrated in FIGS. 10A - 10C, FIGS. 15A - 15G, and FIGS. 15I - 15M, the suture anchor cap 320 includes gripping features 328 configured to facilitate gripping of the suture anchor cap 320 to move the quick release suture mechanism 302 between a locked configuration and an unlocked configuration. The gripping features 328 can include any suitable features and / or be any suitable features, and by way of example, include textured surfaces, recesses, protrusions, knobs, levers, handles, tabs, etc.

[0169] In particular, FIGS. 10A - 10C illustrate an example where the gripping features 328c include a set of ridges for facilitating unscrewing of the suture anchor cap 320 from the quick release dock port 304. In the examples of FIGS. 15A - 15G and FIGS. 15I - 15M, the gripping features 328e include tabs configured to facilitate actuation of the bayonet lock mechanism of the dock port coupling mechanism 310e.

[0170] The suture anchor cap 320 may have any of a variety of structures and / or configurations. In some examples, as shown in FIG. 7, the suture anchor cap 320 includes an internal 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 may additionally include an outer skirt 334 that circumferentially surrounds the internal 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 examples, the suture anchor cap 320 may further include an annular channel 336 defined between the internal plug 332 and the outer skirt 334, whereby 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.

[0171] In an example 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 may include and / or define a cap thread 322, and the outer surface of the quick release dock port 304 may include and / or define a port thread 312. In other examples, the internal plug 332 may include and / or define a cap thread 322, and / or the inner surface of the quick release dock port 304 may include and / or define a port thread 312.

[0172] The suture anchor cap 320 may be configured to operably couple to the release suture 236 in any of a variety of manners. In particular, in various examples, the release suture 236 extends between a suture fixed end 237 and a suture free end 238 and terminates at the suture fixed end 237 and the suture free end 238, and the suture anchor cap 320 includes a suture anchor location 326 configured to couple the suture fixed end 237. Specifically, the suture anchor cap 320 is configured to operably couple to the suture fixed end 237 at the suture anchor location 326 such that the suture fixed end 237 is restricted from disengaging 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).

[0173] In some examples, the suture fixed end 237 is fixedly coupled to the suture anchor location 326 via, for example, an adhesive, a cement, a mechanical coupling, a tie wrap, a mechanical obstruction (e.g., between a knot in the release suture 236 and a small opening in the suture anchor cap 320), and / or other means for fixedly coupling the suture fixed end 237 to the suture anchor location 326.

[0174] As used herein, the suture fixed end 237 and / or the suture free end 238 may refer to the respective corresponding ends of the release suture 236 or, alternatively, to the respective corresponding portions of the release suture 236 that extend proximate to those ends. Thus, for example, the suture fixed end 237 and / or the suture free end 238 may be described as being attached to another component when an area of the release suture 236 proximate to such an end is attached to the other component.

[0175] The quick release suture mechanism 302 is generally configured such that when the quick release suture mechanism 302 is in the locked configuration, the free end 238 of the suture is fixed in place. In particular, when the quick release suture mechanism 302 is in the locked configuration, the free end 238 of the suture is located at least substantially fixed relative to the quick release dock port 304. With such a configuration, it may operate to prevent the release suture 236 from coming off the quick release suture mechanism 302 or from the implantable device before the quick release suture mechanism 302 is shifted to the unlocked configuration.

[0176] Alternatively, when the quick release suture mechanism 302 is in the unlocked configuration, the free end 238 of the suture is free to move through the quick release dock port 304. Thus, when the quick release suture mechanism 302 is in the unlocked configuration, the release suture 236 may be removed from the implantable device by pulling the entire release suture 236 out of the suture lock assembly 300, out of the delivery device 100, and / or out of the implantable device.

[0177] The quick release suture mechanism 302 may 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 may 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.

[0178] As a more specific example, for instance, in the example of FIG. 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 between the port thread 312 and the cap thread 322. Thus, in such an example, the free end 238 of the suture may be locked in place through a screwed engagement between the port thread 312 and the cap thread 322.

[0179] In some examples (see, e.g., FIGS. 7 - 10D), the suture anchor cap 320 defines an internal bore 330 that at least partially extends through the suture anchor cap 320. In particular, FIGS. 7 - 9 illustrate examples where the internal bore 330 extends through the entire length of the suture anchor cap 320, while FIGS. 10A - 10D illustrate examples where the internal bore 330 only partially extends through the suture anchor cap 320. In some examples, an internal plug 332 defines at least a portion of the internal bore 330.

[0180] In some examples, the fixed end 237 and / or the free end 238 of the suture may at least partially extend through the internal bore 330. In some examples (see, e.g., FIGS. 7 - 9), the internal bore 330 may include a suture anchor location 326. For example, the fixed end 237 of the suture may be fixedly coupled to the suture anchor cap 320 (e.g., via an adhesive, cement, and / or any other suitable bonding means) at a location where the fixed end 237 defines the internal bore 330 on the inner surface of the suture anchor cap 320. Additionally or alternatively, as will be described in more detail below, the internal bore 330 may include one or more geometric features (e.g., constrictions, curvatures, etc.) that function as the suture anchor location 326 by at least partially restraining the release suture 236 so that it does not come out of the internal bore 330.

[0181] In some examples, as also illustrated 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 externally of the internal bore 330. In particular, in some such examples, the free end 238 of the suture extends from the suture exit port 354 through the quick release dock port 304 and through the annular channel 336 around the outer surface of the internal plug 332, 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 examples, while a portion of the free end 238 of the suture may enter the internal bore 330, the free end 238 of the suture may be configured such that it is not accessible through the internal bore 330 when the quick release suture mechanism 302 is in a locked configuration.

[0182] In other examples, 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 internal bore 330. For example, as illustrated in FIG. 9, the free end 238 of the suture may extend from the suture exit port 354 through the internal bore 330, around the outer skirt 334, within the annular channel 336 around the end of the quick release dock port 304, and again through the internal bore 330.

[0183] Alternatively, the free end 238 of the suture may extend from the suture exit port 354, through the annular channel 336, around the end of the quick release dock port 304, around the outer skirt 334, and through the internal bore 330.

[0184] In each such example, as in the example of FIG. 8, the free end 238 of the suture may be captured between the port thread 312 and the cap thread 322 when the quick release suture mechanism 302 is in a locked configuration.

[0185] In some examples, the suture anchor cap 320 may define a plurality of internal holes 330. For example, as illustrated in FIGS. 15I-15K, the internal hole 330 may be a first internal hole 330, and the suture anchor cap 320 may further include a second internal hole 331. In such examples, the suture fixed end 237 may at least partially extend through the first internal hole 330, and / or the suture free end 238 may at least partially extend through the second internal hole 331 (e.g., when the quick release suture mechanism is in a locked configuration).

[0186] Each of the suture fixed 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 illustrated in FIG. 15J, the suture fixed end 237 may extend through the first internal hole 330e and may terminate in a knot. Thus, the knotted end of the suture fixed end 237 may fit within the recess at the suture anchor location 326e, but may be too large to pass through the first internal hole 330e.

[0187] As another example, as illustrated in FIG. 15K, the suture fixed end 237 may extend through the first internal hole 330e and may continue around the outside of the internal plug 332e, thereby being tied and / or otherwise fixed to a portion of the release suture 236, and thereby fixing the suture fixed end 237 to the suture anchor cap 320e.

[0188] In other examples, the suture fixed end 237 may be additionally or alternatively attached to the suture anchor location 326, to the first internal hole 330, and / or to the suture anchor cap 320 (e.g., by an adhesive, by a screw, etc.).

[0189] The free end 238 of the suture may also be fixed at a predetermined position relative to the suture anchor cap 320 in any of a variety of ways. In the examples 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 at a pin cap 315e having a diameter wider than the other bayonet pin 314e. In some examples, such as the examples of 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. Stated another way, in such examples, the pin cap 315e may operate to hold the release suture 236 on the bayonet pin 314e. However, this is not required for all examples, and additionally, 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 the pin cap 315e and / or without engaging the pin cap 315e.

[0190] Additionally or alternatively, as shown in FIGS. 15E and 15J-15M, at least one bayonet pin 314e may include a lateral pin hole 317e extending through the diameter of the bayonet pin 314e. In such examples, as shown in FIGS. 15J-15K, the release suture 236 and / or its free end 238 of the suture may extend through the lateral pin hole 317e to hold the free end 238 of the suture at least partially in a predetermined position relative to the bayonet pin 314e.

[0191] Additionally or alternatively, in some examples, the free end 238 of the suture can be wound around each of a pair of bayonet pins 314e. For example, the free end 238 of the suture can be wound around the first bayonet pin 314e, around the end of the quick release dock port 304e, and around the second bayonet pin 314e. In such examples, the free end 238 of the suture can be wound around the quick release dock port 304e and the bayonet pins 314e in a figure-eight pattern. It is further within the scope of the present disclosure that any other suitable pattern or configuration can be used when winding the free end 238 of the suture around one or more components of the quick release suture mechanism 302 to achieve a desired suture holding strength or the like.

[0192] In some examples, as shown in FIGS. 15J - 15L, when the quick release suture mechanism 302e is in a locked configuration, the free end 238 of the release suture 236 can be wound around the bayonet pin 314e by extending through the second internal hole 331e and further through the annular channel 336e. In some such examples, the engagement between the free end 238 of the suture and one or both of the bayonet pin 314e and the bayonet slot 324e can be sufficient to maintain the free end 238 of the suture in a predetermined position when the quick release suture mechanism 302e is in a locked configuration.

[0193] In other examples, as shown in FIG. 15M, when the quick release suture mechanism 302e is in a locked configuration, the suture free end 238 of the release suture 236 can extend through the internal hole 331e and further through the annular channel 336e (as shown in FIGS. 15J - 15K), and by extending to the outside of the outer skirt 334e, it may 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 a tension may be applied between the edge of the outer skirt 334e and the bayonet pin 314e, whereby the suture free end 238 may be further fixed to the bayonet pin 314e.

[0194] In some examples, the suture free end 238 may additionally or alternatively be fixedly coupled to the suture anchor cap 320, at least when the quick release suture mechanism 302 is in a 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 examples, the release suture 236 may be removed from the suture lock assembly 300 / 400 and / or from 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 examples, the unlocked 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 then the suture free end 238 is removed from the suture anchor cap 320.

[0195] In other examples, the quick release suture mechanism 302e of FIGS. 15A-15I may be used such that the free end 238 of the suture does not extend through the second internal 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 may be additionally or alternatively coupled to the bayonet pin 314e of the quick release dock port 304e (e.g., may be wound around the bayonet pin 314e), at least when the quick release suture mechanism 302e is in a locked configuration. Thus, in such examples, the quick release suture mechanism 302e may transition from a locked configuration to an unlocked configuration by first disconnecting the free end 238 of the suture from the bayonet pin 314e (e.g., by unwinding the winding).

[0196] In some examples, 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 examples, 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 a locked configuration. In some examples, the gasket 316 may be disposed inside the suture exit port 354 and / or inside the quick release dock port 304.

[0197] Additionally or alternatively, in some examples, gasket 316 may be configured to limit the escape of fluid from quick release dock port 304 when quick release suture mechanism 302 is in an unlocked 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 escaping from quick release dock port 304 when suture anchor cap 320 is removed.

[0198] In some examples, gasket 316 may include and / or be a gasket that opens when compressed, such as a gasket commonly used in needleless valves. In such examples, 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 closed to fluid flow when suture anchor cap 320 is removed from quick release dock port 304.

[0199] As another example, gasket 316 may include and / or be a Tuohy Borst gasket, such a Tuohy Borst gasket being compressed and closed when suture anchor cap 320 is operably coupled to quick release dock port 304 and slightly opening when suture anchor cap 320 is removed from quick release dock port 304. In such examples, the slight opening of gasket 316 may facilitate pulling release suture 236 through gasket 316.

[0200] In an example where the dock port coupling mechanism 310 includes a bayonet pin 314 and a bayonet slot 324, the gasket 316 may 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 may slightly compress the gasket 316e, whereby the gasket 316e biases the suture anchor cap 320e axially outward, thereby biasing the bayonet pin 314e to engage with the bayonet slot 324e. In other words, when the quick release suture mechanism 302e is in the locked configuration, the gasket 316e can maintain the engagement between the bayonet pin 314e and the bayonet slot 324e by biasing the suture anchor cap 320e axially outward. In this way, the gasket 316e can also introduce a two-stage removal mechanism for the quick release suture mechanism 302e by requiring the user to push the suture anchor cap 320e axially inward against the outward force of the gasket 316e before rotating the suture anchor cap 320e relative to the quick release dock port 304e.

[0201] Additionally, as shown in FIGS. 15J - 15M, in an example 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 an engaged state with the bayonet slot 324e may 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 bias the bayonet pin 314e into an engaged state with the bayonet slot 324e may function to fix the suture free end 238 of the release suture 236 in place when the quick release suture mechanism 302e is in the locked configuration.

[0202] Additionally or alternatively, in some examples, as shown in FIGS. 15L - 15M, a portion of the bayonet slot 324e may define a recess for receiving the bayonet pin 314e by extending toward the quick release dock port 304e (e.g., when the quick release suture mechanism 302e is in the locked configuration). Thus, in such examples, it may be necessary to axially inwardly press the suture anchor cap 320e against the gasket 316e after rotating the suture anchor cap 320e and before removing it from the quick release dock port 304e.

[0203] In some examples, as shown in FIG. 7, the quick release suture mechanism 302 additionally includes one or more suture centering members 358 configured to guide the release suture 236 through the tensioner housing 350. For example, if present, each suture centering member may be configured to engage the tensioner housing 350 (e.g., inside the suture introduction port 352 or inside the suture exit port 354) and may be configured to support the release suture 236 through its central hole or passageway, such that at least a portion of the release suture 236 is maintained spaced from the inner surface of the tensioner housing 350. In some examples, the gasket 316 may act as the suture centering member 358.

[0204] As further illustrated in FIG. 7, the suture lock assembly 300 may additionally include a cleaning port 360 that is fluidly coupled to the suture introduction port 352 for supplying cleaning fluid into and / or downstream of the tensioner housing 350 and / or the delivery device 200. In some such examples, the tensioner housing 350 at least partially defines the cleaning 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 lock assembly 300 from the delivery device connection 306, thereby delivering the cleaning fluid to the delivery device 200 via the tensioner housing 350 without losing hemostasis.

[0205] When present, the cleaning port 360 may include any suitable port and / or coupling, such as a port that is normally sealed and opens when another component (e.g., a cleaning fluid source) is operably coupled to the cleaning port 360, and / or may be such any suitable port and / or coupling. In some examples, the cleaning port 360 may include a luer lock port and / or a swappable luer lock port, and / or may be a luer lock port and / or a swappable luer lock port.

[0206] FIGS. 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, FIG. 10A illustrates a suture anchor cap 320c operably coupled to the quick release dock port 304c, whereby the quick release suture mechanism 302c is in a locked configuration.

[0207] FIG. 10B illustrates a suture anchor cap 320c removed from the quick release dock port 304c, whereby the quick release suture mechanism 302c is in an unlocked configuration. As shown in FIG. 10B, the suture fixed end 237 is fixedly coupled to the suture anchor cap 320c within the internal bore 330, while the suture free end 238 extends from the quick release dock port 304c.

[0208] By pulling the suture anchor cap 320c away from the quick release dock port 304c (e.g., to the configuration of FIG. 10C) with the suture free end 238 released from the interface between the suture anchor cap 320c and the quick release dock port 304c, the suture free end 238 is pulled into the quick release dock port 304c and into the implantable device. When the suture anchor cap 320c is further pulled away, the suture free end 238 may be completely withdrawn from the implantable device and from the quick release dock port 304c, as shown in FIG. 10D.

[0209] The above description of the suture anchor cap 320 generally relates to an example where the suture lock assembly 216 / 300 includes a spool 278 / 340 for applying tension to the release suture 236, but this is not required for all examples. For example, FIG. 11 illustrates an example of a suture lock assembly 400 that includes a suture tensioner 402 for engaging and selectively applying tension to a release suture 236 attached to an implantable device (e.g., a docking device 70, etc.). The suture anchor cap 320 can also be used with other delivery assemblies where the implantable device is removably coupled to a delivery device by one or more sutures. For example, as described above, the suture anchor cap 320 can be used with a docking device delivery device 50 and / or an artificial valve delivery device 60 that do not have a mechanism for adjusting the slack of the release suture 236.

[0210] Suture lock assembly 400 may include any features, characteristics, attributes, etc. disclosed herein with reference to suture lock assembly 216 and / or suture lock assembly 300, and vice versa. In particular, FIG. 11 illustrates an example in which suture lock assembly 400 includes the quick release suture mechanism 302 described above with reference to FIGS. 7-10D.

[0211] Although the present disclosure generally relates to examples in which suture lock assembly 400 is used with release suture 236, this is not essential, and additionally, it is within the scope of the present disclosure that suture lock assembly 400 can be used with any suitable suture. For example, suture lock assembly 400 may be used with sutures that are not configured to couple to a transplantable device and / or with sutures that are not configured to release a transplantable device. Thus, as used herein, release suture 236 may additionally or alternatively be referred to as suture 236.

[0212] As shown in FIG. 11, suture lock assembly 400 includes a tensioner housing 450 that at least partially receives suture tensioner 402. Tensioner housing 450 includes a suture introduction port 452, whereby release suture 236 extends between the transplantable device and suture tensioner 402 via suture introduction port 452. In some examples, as shown in FIG. 11, tensioner housing 450 additionally includes a suture exit port 454, whereby release suture 236 extends through tensioner housing 450 between suture introduction port 452 and suture exit port 454.

[0213] As shown in FIG. 11, the suture lock assembly 400 and / or the suture introduction port 452 may be configured to be operably coupled to the delivery device connection portion 306 of the delivery device 200. Thus, the suture lock assembly 400 may be configured such that the release suture 236 extends between the suture tensioner 402 and the implantable device via the delivery device connection portion 306. As an example, the delivery device connection portion 306 may represent a portion of the branch 244 of the adapter 240 shown in FIG. 6B.

[0214] FIGS. 12A-15M illustrate more specific examples of the suture lock assembly 400 and / or its components, as will be described in more detail below. In particular, FIGS. 12A-12G illustrate a suture lock assembly 400a forming a first example, while FIG. 13 illustrates a suture lock assembly 400b forming a second example. FIGS. 14A-14B illustrate a suture lock assembly 400c forming a third example incorporating a quick release suture mechanism 302d forming a fourth example, and FIGS. 15A-15M illustrate a suture lock assembly 400d forming a fourth example incorporating a quick release suture mechanism 302e forming a fifth example. In general, the features, characteristics, attributes, etc. of the suture lock assembly 400 disclosed herein with reference to FIG. 11 can be understood to also apply to any suture lock assembly 400a / 400b / 400c / 400d, and vice versa.

[0215] Returning to FIG. 11, the suture tensioner 402 of the suture lock assembly 400 is configured to selectively rotate relative to the tensioner housing 450 about the tensioner central axis 404. Specifically, the suture tensioner 402 includes a pair of spaced posts 430 coupled to each other via a connection body 420 (e.g., an arm, hub, disk, wheel, etc.), such that when the suture tensioner 402 rotates, both posts 430 are configured to rotate integrally about the tensioner central axis 404. In some examples, both posts 430 and / or the connection body 420 may collectively be referred to as a fork-type tension applying mechanism.

[0216] When the suture tensioner 402 is rotated relative to the tensioner housing 450 in a first direction (e.g., counterclockwise in the example of FIG. 11), both posts 430 engage the release suture 236 to gather (e.g., wind up) the length of the release suture 236, thereby selectively increasing the length of the release suture 236 enclosed by the tensioner housing 450 and thereby selectively increasing the tension of the release suture 236. In some examples, the suture lock assembly 400 may be configured such that the release suture 236 extends from the suture tensioner 402 through the suture introduction port 452 to the implantable device and back to the suture tensioner 402 via the suture introduction port 452. Thus, in such examples, rotating the suture tensioner 402 in the first direction to increase the length of the release suture 236 accommodated within the tensioner housing 450 acts to increase the tension of the release suture 236 between the suture tensioner 402 and the implantable device.

[0217] After rotating the suture tensioner 402 in the first direction and with the release suture 236 in a tensioned state, rotating the suture tensioner 402 in a second direction opposite to the first direction (e.g., clockwise in the example of FIG. 11) acts to gradually release the tension of the release suture 236. When the suture tensioner 402 is rotated in the second direction, the release of the tension may allow a slack to be formed in the release suture 236. For example, when the tension applied by the suture tensioner 402 is released and no external tension acts to pull the release suture 236 out of the tensioner housing 450 via the suture introduction port 452, the slack release suture 236 may remain within the tensioner housing 450. As will be described in more detail below, the configuration in which the two posts 430 are separated allows the slack release suture 236 to occupy the tensioner housing 450 and / or to return to the tensioned configuration while minimizing the risk of entanglement.

[0218] In some examples, as illustrated in FIG. 11 and as will be described in more detail below, the suture lock 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 described herein. In particular, in some such examples, the quick release suture mechanism 302 is coupled to and / or incorporated into the suture exit port 454. In such examples, the suture lock assembly 400 may be described as being similar and / or equivalent compared to an example of the suture lock assembly 300 in which the spool 340 is replaced by the suture tensioner 402 as described herein.

[0219] However, in other examples, the suture lock 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 examples, the tensioner housing 450 may not have a suture exit port 454, and / or a portion of the release suture 236 may be fixedly coupled to one of the two 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, and at least one of the first end and the second end is fixedly coupled to a respective suture anchor position 440 of the suture tensioner 402. As shown in FIG. 11, at least one of the two posts 430 may include and / or define such a suture anchor position 440.

[0220] Each of the two posts 430 may have any suitable shape and / or configuration for engaging the release suture 236 as described herein. In some examples, as shown in FIGS. 11-12G, 14A, and 15D-15H, each post 430 is substantially cylindrical and has a circular cross-sectional shape.

[0221] However, this is not required for all examples, and additionally, 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 shown in FIG. 13 and as described in more detail below, each post 430 may have an asymmetric shape such as a male-female shape.

[0222] As an additional example, each post 430 may have a shape that is conical and / or frustoconical, and / or may have a cross-sectional shape that is curved, circular, oval, and / or elliptical.

[0223] Additionally, although the present disclosure generally relates to examples where both posts 430 are at least substantially identical to each other (e.g., in terms of shape and / or size), it is also within the scope of the present disclosure that a pair of posts 430 can differ in terms of shape and / or size.

[0224] FIG. 11 illustrates a configuration in which the suture tensioner 402 applies tension to the release suture 236, and FIGS. 12A - 12G illustrate a series of events in which the suture tensioner 402a applies an increasing tension to the release suture 236 and then releases this tension.

[0225] The suture tensioner 402 can be described as transitioning between a plurality of tensioner configurations for selectively applying tension to the release suture 236. For example, rotating the suture tensioner 402 relative to the tensioner housing 450 can be described as an action that transitions the suture tensioner 402 between a plurality of tensioner configurations defined between a release configuration and a full - tension configuration.

[0226] In the release configuration, both posts 430 are arranged so as to apply little or no (or only a negligible amount of) 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 two posts 430 may be spaced apart from, or be tangential to, a straight line connecting the suture inlet port 452 and the suture outlet port 454. In particular, FIG. 12A illustrates 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 apart from the release suture 236.

[0227] In various examples, any plurality of rotational orientations of the suture tensioner 402 with respect to the tensioner housing 450, where the two posts 430 are spaced apart from such a straight line connecting the suture introduction port 452 and the suture exit port 454, can be described as representing a release configuration.

[0228] Describing sequentially through each configuration illustrated in FIGS. 12A - 12E, it will be understood that rotating the suture tensioner 402a with respect to the tensioner housing 450a (counterclockwise in this example) acts to engage the two posts 430a with respect to the release suture 236. When the rotation of the suture tensioner 402a continues, the two posts 430a wind up more of the length of the release suture 236, thereby increasing the length of the release suture 236 extending between the suture introduction port 452a and the suture exit port 454a. This can act to increase the tension of 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 in place with respect to the suture lock assembly 400. FIG. 12E represents the full tension configuration of the suture tensioner 402a, where in this case the two posts 430a are arranged to engage the release suture so as to provide maximum tension to the release suture when the release suture 236 is coupled to the transplantable device.

[0229] FIGS. 12E - 12G illustrate a series of events in which the tension of the release suture 236 is decreased by rotating the suture tensioner 402a with respect to the tensioner housing 450a (clockwise in this example), starting from the full tension configuration. In particular, when the distal end of the release suture 236 is coupled to a transplantable device that does not experience a distal - 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 occur in the release suture 236.

[0230] As shown in FIGS. 12F - 12G, since the two posts 430a that act to apply tension to the release suture 236 are spaced apart from each other, the space between the posts 430a allows the release suture 236 to release its tension with a low risk of entanglement. Specifically, since the release suture 236 does not experience a distal - directed force (i.e., a force directed outward from the tensioner housing 450a through the suture introduction port 452a) in this example, the length of the release suture 236 housed within the tensioner housing 450a remains substantially unchanged even when the tension applied by the suture tensioner 402a is released.

[0231] As shown in FIG. 12G, the two spaced - apart posts 430a can provide sufficient volume for the release suture 236 to spread without entanglement. In particular, and as shown in FIGS. 11 - 13, the tensioner housing 450 may include and / or define a tensioner chamber 422 that surrounds at least a portion of the two 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 lock assembly 400 may be configured such that the suture tensioner 402 can be rotated to a position where the two posts 430 are spaced apart from the release suture 236 (e.g., the release configuration).

[0232] In contrast to a suture lock assembly that uses a spool to apply tension to a release suture, the two posts 430 of the suture lock assembly 400 that are spaced apart from each other may provide a greater ability to increase the length of the release suture 236 within the tensioner housing 450 with each rotation of the suture tensioner 402. For example, when a spool (e.g., spool 278 or spool 340) is rotated by half a turn, a release suture 236 having a length approximately equal to half the circumference of the spool is collected. In contrast, as can be understood by comparing FIGS. 12A and 12E (described in more detail below), when the suture tensioner 402 is rotated by half a turn, a release suture 236 having a length approximately equal to twice the distance by which the posts 430 are spaced apart can be collected.

[0233] Additionally, the two posts 430 of the suture tensioner 402 that are spaced apart from each other may enhance the stability and / or fixation of the release suture 236 with respect to a suture lock assembly that utilizes a spool when the suture tensioner 402 is in a fully tensioned configuration. For example, referring to the suture lock assembly 300 of FIG. 7, when the spool 340 acts to apply tension to the release suture 236, the release suture 236 applies a torque to the spool 340 having a magnitude equal to the product of the tension in 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 fully tensioned configuration, since the release suture 236 is at least substantially aligned with the two posts 430a, the release suture 236 may apply only a minimal torque to the suture tensioner 402a. Thus, compared to a configuration that utilizes a spool (e.g., spool 278 or spool 340) to apply tension to the release suture 236, to maintain the suture tensioner 402a in a fully tensioned configuration (e.g., to counteract the pulling force of the release suture 236), less force and / or less mechanical resistance may be required.

[0234] As described above with reference to FIGS. 12A and 12G, suture tensioner 402 can be described as being in a released configuration when suture tensioner 402 is in any of a variety of rotational configurations such that both posts 430 do not interfere with release suture 236 and / or do not apply tension to release suture 236. For example, as shown in FIG. 12G, the two spaced-apart posts 430a may be arranged in any of a variety of rotational configurations corresponding to the released configuration while providing a volume.

[0235] Similarly, the full tension configuration of suture tensioner 402 may refer to any rotational configuration of suture tensioner 402 and / or posts 430 relative to tensioner housing 450 such that the length of release suture 236 extending within tensioner housing 450 is maximized by both posts 430.

[0236] In the example of FIGS. 12A - 12G, suture tensioner 402 is rotated relative to tensioner housing 450 by an angle of about 180 degrees in order to transition suture tensioner 402 between the released configuration and the full tension configuration. However, this is not required for all examples, and additionally, it is within the scope of the present disclosure that suture tensioner 402 can be rotated by any suitable angle for transitioning between the released configuration and the full tension configuration. By way of example, suture tensioner 402 may be configured to rotate relative to tensioner housing 450 by 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.

[0237] In some examples, the suture lock assembly 400 may include one or more features to mechanically limit the rotational range of motion of the suture tensioner 402 and / or to define a release configuration and / or a full tension configuration. For example, as illustrated in FIG. 11, the suture lock assembly 400 may include one or more rotator locking portions 442 that are fixed in a predetermined position relative to the tensioner housing 450. In some examples, at least one rotator locking portion 442 extends into the tensioner chamber 422 and is configured to engage one or both of the posts 430 when the suture tensioner 402 is in the release configuration and / or the full tension configuration, thereby defining the release configuration and / or the full tension configuration.

[0238] Additionally or alternatively, at least one rotator locking portion 442 may be positioned outside of the tensioner chamber 422 and / or may be positioned to engage a rotator 410 (described in more detail below) that rotates the suture tensioner 402. For example, the rotator 410 may include a rotator locking portion 442 in the form of a component that engages a corresponding component of the tensioner housing 450 to define a release configuration and / or a full tension configuration. In some examples, by using a single rotator locking portion 442, it is possible to rotate the suture tensioner 402 by approximately one revolution and / or a fraction of one revolution before being mechanically limited by the rotator locking portion 442. Examples of the rotator 410 are illustrated as rotator 410c in FIGS. 14A-14B, as rotator 410d in FIGS. 15A-15C and FIGS. 15E-15H, and thus references to the rotator 410 herein are to be understood as relating to rotator 410c, rotator 410d, and / or the rotator in any other example described herein.

[0239] Each post 430 may be configured to engage the release suture 236 in any suitable manner. As illustrated in FIG. 11, each post 430 may be described as including a suture engagement surface 432 that engages the release suture 236 during operation of the suture lock assembly 400 (e.g., when the suture tensioner 402 is acting to apply tension to the release suture 236).

[0240] In some examples, each suture engagement surface 432 is the outer surface of the corresponding post 430 and / or is otherwise relatively fixed with respect to the remainder of the corresponding post 430 and / or the connection body 420. Thus, in such examples, the suture tensioner 402 may be configured such that the release suture 236 slides against each suture engagement surface 432 when the suture tensioner 402 is rotated relative to the tensioner housing 450. That is, in an example where each suture engagement surface 432 has a fixed orientation with respect 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 also rotates about an axis parallel to the tensioner central axis. Thus, with such movement, there is a possibility that the release suture 236 slides against each suture engagement surface 432 when both posts 430 move to engage the release suture 236.

[0241] In other examples, the suture tensioner 402 may be configured such that when the suture tensioner 402 is rotated, the release suture 236 remains at least substantially statically in contact with each suture engagement surface 432. As an example, as illustrated in FIG. 11, the suture tensioner 402 may include a pair of rollers 438, each roller being rotatably coupled to a corresponding post 430, and each roller including a corresponding suture engagement surface 432. For example, each roller 438 may circumferentially surround a corresponding post 430 and / or may be rotatably coupled to a corresponding post 430, such as via a bearing.

[0242] As another example, each post 430 may be rotatably coupled to the connection body 420. In particular, each post 430 may define a corresponding suture engagement surface 432, and the entire post 430 (or at least substantially the entire post) may be configured to rotate relative to the connection body 420.

[0243] In such examples, each suture engagement surface 432 may be rotated relative to the connection body 420 such that when the suture tensioner 402 is rotated, the suture engagement surface 432 remains at least substantially statically in contact with the release suture 236. Stated another way, in such examples, due to the static friction between the release suture 236 and each suture engagement surface 432, when the suture tensioner 402 is rotated, each suture engagement surface 432 may be rotated relative to the connection body 420 and / or relative to a corresponding post 430. Thus, by configuring in this way, it may be facilitated to increase or decrease the tension of the release suture 236 by rotation of 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.

[0244] In an example 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 lock assembly 400, which may function to avoid local stresses within the release suture 236. Additionally, a larger circular post 430 may further accommodate an increase in the length of the release suture 236 that is wound up 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 corresponding wide area between the posts 430 for the release suture 236 to expand internally when relaxed.

[0245] As described above, FIG. 13 illustrates an example where each post 430b has an asymmetric male-female shape. FIG. 13 can also be described as representing an example where each post 430 has a greater width (e.g., when measured along a direction perpendicular to and intersecting the tensioner central axis 404b) at the front edge 434b than at the rear edge 436b.

[0246] Referring to the example of FIG. 13, each post 430b can be described such that each suture engagement surface 432b extends between a front edge 434b and a rear edge 436b of the corresponding post 430b. In particular, compared to the circular posts 430a in FIGS. 12A-12G, the male-female shape of the post 430c in FIG. 13 can provide an elongate suture engagement surface 432c without significantly reducing the open space between the posts 430c. By configuring in this way, the force of each post 430c on the release suture 236 can function to disperse over a wider range of the length of the release suture 236, which may facilitate applying tension to the release suture 236 by 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 lock assembly 400c (e.g., with respect to the suture lock assembly 400b of FIGS. 12A-12G), which may function to avoid local stress within the release suture 236. Moreover, by configuring in this way, compared to the configuration using circular posts 430, it may function to increase the length of the suture 236 wound by the male-female shaped post 430c per revolution of the suture tensioner 402.

[0247] Figures 14A-14B illustrate a suture lock assembly 400c that forms a third example, which includes a suture tensioner 402a in combination with a quick release suture mechanism 302 that forms a fourth example. In the example of Figures 14A-14B, the suture lock assembly 400c is configured such that a tensioner housing 450c extends adjacent to a portion of the delivery device 200a. In particular, Figures 14A-14B illustrate an example such that the tensioner housing 450c extends adjacent to and / or is a component of a hub assembly 218a of the delivery device 200a that at least partially surrounds a sleeve shaft 220a and a push shaft 212a. Similar to the hub assembly 218 described above, the hub assembly 218a (along with the suture lock assembly 400c) can be used to independently control the push shaft 212a and the sleeve shaft 220a, while a sleeve handle 224a can control the axial position of the sleeve shaft 220 relative to the push shaft 212.

[0248] As shown in FIGS. 14A-15C and FIGS. 15E-15H, the suture lock assembly 400 may include a rotor 410 configured to be manually driven by a user to rotate the suture tensioner 402 relative to the tensioner housing 450. In some examples, as shown in FIGS. 14A and 15E-15H, the rotor 410 is fixedly coupled to and / or integrally formed with each post 430. Similarly, in some examples, the rotor 410 may be fixedly coupled to and / or include and / or define the connection body 420. In particular, in the example of FIGS. 15E-15H, the rotor 410d, the connection body 420d, and the post 430d are integrally formed as a single piece such that the rotor 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 side opposite the rotor 410d, and this bottom plate restricts the release suture 236 from falling from the post 430d. Thus, the connection body 420d can be described as acting to hold the release suture 236 within the tensioner housing 450d.

[0249] In some examples, one or more components of the suture tensioner 402 are configured to be removably coupled to the tensioner housing 450. In other words, at least a portion of the suture tensioner 402 is configured to be coupled to the tensioner housing 450 (e.g., assembled to the tensioner housing 450) in such a manner that the suture tensioner 402 can be removed from the tensioner housing 450 without damaging the suture tensioner 402 and / or the tensioner housing 450.

[0250] As a more specific example, FIG. 14A illustrates an example in which the rotor 410c includes a plurality of lock tabs 418c configured to limit removal of the rotor 410c from the tensioner housing 450c.

[0251] As another example, FIGS. 15E - 15G illustrate an example in which the tensioner housing 450d includes a plurality of lock tabs 456d configured to limit removal of the rotor 410d from the tensioner housing 450d.

[0252] Accordingly, in these examples, the rotor 410, the connection body 420, and the post 430 may be integrally formed (e.g., molded) as an integral member that can be easily assembled to the tensioner housing 450 by inserting these components into the tensioner housing 450 until the lock tabs (e.g., lock tab 418c or lock tab 456d) engage and hold against the rotor 410 and / or the tensioner housing 450. After the rotor 410, the connection body 420, and / or the post 430 are thus fully inserted into the tensioner housing 450, the lock tabs 418 and / or the lock tabs 456 may function to limit and / or prevent disassembly of the suture lock assembly 400.

[0253] In various examples, the rotor 410 may include one or more features to facilitate gripping of the rotor 410 and / or to facilitate rotating the suture tensioner 402 into a desired tensioner configuration. For example, in the examples of FIGS. 15A-15C and FIGS. 15G-15H, the rotor 410d includes a gripping portion 412d configured to facilitate gripping the rotor 410d to manually rotate the suture tensioner 402d relative to the tensioner housing 450d. In the examples of FIGS. 15A-15C and FIGS. 15G-15H, the gripping portion 412d includes a plurality of recesses circumferentially distributed around the periphery of the rotor 410d. In other examples, the gripping portion 412 may additionally or alternatively include any suitable gripping feature and / or be any suitable gripping feature, examples of which include a textured surface, recesses, protrusions, knobs, levers, handles, tabs, etc.

[0254] In some examples, the suture tensioner 402 and / or the tensioner housing 450 may include one or more features to provide an indication of the rotational position of the rotor 410 relative to the tensioner housing 450. For example, FIG. 14B illustrates an example where the suture lock assembly 400c includes an indicator 416c configured to provide a visual indication regarding the configuration of the tensioner. In the example of FIG. 14B, each of the rotor 410c and the tensioner housing 450c includes a part of the indicator 416c. Specifically, in this example, the indicator 416c includes a mark on the tensioner housing 450c and a pair of marks spaced circumferentially on the rotor 410c. Thus, each mark on the rotor 410c may 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 examples, the indicator 416 may include any additional or alternative visual indicator and / or be such a visual indicator, examples of which include marks, printed marks, embossed marks, debossed marks, numerical scales, etc.

[0255] Additionally or alternatively, in some examples, the suture lock assembly 300 and / or the suture lock assembly 400 includes one or more features that selectively restrict access to the quick release suture mechanism 302. In particular, as shown in phantom in FIG. 14B, the suture lock assembly 400c may include a safety handle 414c operably coupled to the rotor 410c and extending away from the rotor 410c. Specifically, when the rotor 410c is in a predetermined rotational orientation, such as a full tension configuration, with respect to the tensioner housing 450c, the safety handle 414c may obstruct and / or prevent manual access to the quick release suture mechanism 302d by covering the quick release suture mechanism 302d.

[0256] In particular, when the suture tensioner 402 is in a full tension configuration, it may be desirable to ensure that the quick release suture mechanism 302 remains in a locked configuration. Thus, when present, the safety handle 414 (e.g., the safety handle 414c of FIG. 14B) may reduce the likelihood that the suture anchor cap 320 inadvertently disengages from the quick release dock port 304 before the tension on the release suture 236 is released. In such examples, rotating the rotor 410 to orient and / or transition the suture tensioner 402 to a release configuration (e.g., by gripping and rotating the safety handle 414) acts to pull the safety handle 414 away from the quick release suture mechanism 302, thereby enabling access to the suture anchor cap 320.

[0257] In some examples, the suture lock assembly 400 may include one or more features for limiting and / or preventing unintended rotation of the rotor 410 relative to the tensioner chamber 422. For example, the suture lock assembly 400 may include an orientation selector, such as a mechanism similar to the orientation selector 274 of FIGS. 6B-6C, to allow the rotor 410 to rotate in only one direction to prevent rotation in an improper orientation. In some examples, the orientation selector can include a ratchet mechanism, such as a switchable ratchet mechanism that allows a user to select a desired rotation orientation. In particular, the orientation selector can allow a user to switch such a switchable ratchet mechanism between a first mode in which the rotor 410 is rotatable to increase the tension of the release suture 236 and rotation to decrease the tension of the release suture 236 is blocked, and a second mode in which the rotor 410 is rotatable to decrease the tension of the release suture 236. In some such examples, the rotor is prevented from rotating to increase the tension of the release suture 236 when in the second mode.

[0258] As another example (see FIGS. 15F-15G), the suture lock assembly 400d can include a rotor lock mechanism 490d configured to limit rotation of the rotor 410d away from one or more predetermined configurations (e.g., a full tension configuration). In particular, in this example, the rotor 410d includes a rotor lock channel 424d that is accessible from below the rotor 410d, and the rotor receiving member 482d includes a rotor lock protrusion 428d that extends into the rotor lock channel 424d. To illustrate this configuration, FIG. 15F is a cross-sectional view of the suture lock assembly 400 taken by a plane intersecting the rotor 410d at the top of the rotor lock channel 424d. The rotor lock mechanism 490d can be described as including the rotor lock channel 424d and the rotor lock protrusion 428d.

[0259] Referring to FIG. 15F, rotating the rotor 410d relative to the tensioner housing 482d acts to move the rotor lock channel 424d relative to the rotor lock projection 428d, thereby repositioning the rotor lock projection 428d within the rotor lock channel 424d. The rotor 410d may additionally include a detent 426d that functions to increase the radius of the rotor lock channel 424d (e.g., relative to the tensioner central axis 404d) to partially limit rotation of the rotor 410d relative to the tensioner housing 482d. For example, rotating the rotor 410d to a position where the rotor lock projection 428d engages the detent 426d may limit further rotation of the rotor 410d in the same direction unless sufficient torque is applied to the rotor 410d to deflect the rotor lock projection 428d away from the tensioner central axis 404d and / or deflect the detent 426d toward the tensioner central axis 404d.

[0260] Additionally, as shown in FIG. 15F, the rotor lock channel 424d may include a lock projection receiving member 425d that can receive the rotor lock projection 428d when the rotor 410d is rotated to a position corresponding to a full tension configuration. The lock projection receiving member 425 may be defined in part by the detent 426d to limit rotation of the rotor 410d to release the tension of the release suture unless sufficient torque is applied to the rotor 410d to move the detent 426d beyond the rotor lock projection 428d when the suture tensioner 402d is in a full tension configuration.

[0261] In the example of FIG. 15F, the rotor locking mechanism 490d includes a single detent 426d that partially defines a single corresponding lock projection receiving member 425d, which corresponds to a single predetermined configuration (e.g., a full tension configuration) of the suture locking assembly 400d. In other examples, the rotor locking mechanism 490d can act to define a plurality of such predetermined configurations, such as corresponding to a release configuration or a partial tension configuration of the suture locking assembly 400d. For example, such a rotor locking mechanism 490d can include a plurality of detents 426d and / or can include a plurality of lock projection receptions 425d.

[0262] The rotor locking mechanism 490d can additionally or alternatively 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 rotor locking projection 428 can be biased radially inwardly or radially outwardly and can be configured to be received in a groove, notch, etc. that extends radially inwardly or radially outwardly from the rotor locking channel 424d when the rotor 410d is rotated to a position corresponding to a predetermined configuration of the suture locking assembly 400d.

[0263] In some examples, as shown in FIGS. 11 and 15D - 15G, the suture locking assembly 400 additionally includes one or more suture centering members 458 configured to guide the release suture 236 through the tensioner housing 450. For example, if present, each suture centering member can be configured to engage the tensioner housing 450 (e.g., within the suture introduction port 452 or within the suture exit port 454) and, by supporting the release suture 236 through its central hole, can be configured to maintain at least a portion of the release suture 236 spaced from the inner surface of the tensioner housing 450.

[0264] As further illustrated in FIGS. 11 and 14A-15G, the suture lock assembly 400 may additionally include a cleaning port 460 fluidly coupled to the suture introduction port 452 for supplying cleaning fluid into and / or to a downstream portion of the delivery device 200. Specifically, the cleaning port 460 may be fluidly coupled to the suture introduction port 452 via the tensioner chamber 422. In some such examples, the tensioner housing 450 at least partially defines the cleaning port 460. In the example 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 lock assembly 400d from the delivery device connection 306 (shown in FIG. 11), and the cleaning fluid may be supplied to the delivery device 200 via the tensioner housing 450 without loss of hemostasis.

[0265] When present, the cleaning port 460 may include any suitable port and / or coupling, such as a port that is normally sealed and opens when another component (e.g., a cleaning fluid source) is operably coupled to the cleaning port 460, and / or may be such a port and / or coupling. In some examples, the cleaning port 460 may include a luer lock port and / or a swappable luer lock port, and / or may be a luer lock port and / or a swappable luer lock port.

[0266] As described above, the suture lock assembly 400d of FIGS. 15A-15M represents an example where the suture lock assembly includes an example of a quick release suture mechanism 302, particularly 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 the suture lock assembly housing 470d.

[0267] As shown in FIG. 15D, the suture lock 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 extend through the entire suture lock assembly housing 470d and may be configured to receive components of the delivery device, such as the sleeve shaft 220 of the delivery device 200. The second conduit 486d communicates with the suture tensioner 402d, whereby the release suture 236 extends through the second conduit 486d to the suture tensioner 402d. Thus, the first conduit 484d and the second conduit 486d may respectively correspond to the straight section 242 and the branch portion 244 of the adapter 240 in FIG. 6B.

[0268] In the example of FIGS. 15A-15M, the suture lock 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 a top outer housing portion 474d and a bottom outer housing portion 476d that are configured to be assembled to each other on both sides of the inner housing 480d so as to at least substantially surround the inner housing 480d.

[0269] In the example of FIGS. 15A-15M, the inner housing 480d includes and / or defines a rotor receiving member 482d that receives each of the first conduit 484d and the second conduit 486d and at least a portion of the suture tensioner 402d. In particular, as shown in FIGS. 15E-15G, the rotor receiving member 482d defines a lock tab 456d.

[0270] In certain examples, for instance, by using one or more annular seal members (e.g., O-rings) 258, a seal can be provided within the suture lock assembly 400, thereby preventing blood, saline, or other fluids from leaking through the system. For example, as shown in FIGS. 14A and 15E, the suture lock assemblies 400c / 400d can include O-rings 258c / 258d configured to form a seal between the rotor 410c / 410d and the tensioner housing 450c / 450d. Additionally or alternatively, the suture lock assemblies 300 / 400 may include one or more O-rings 258 configured to seal the release suture path when the suture lock assembly 300 / 400 is assembled, thereby enabling hemostasis when connected to a properly sealed delivery device.

[0271] 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 in the method. Examples of sterilization by heat / thermal include sterilization by steam and sterilization by autoclave. Examples of radiation for use in sterilization include, but are not limited to, gamma rays, ultraviolet rays, and electron beams. Examples of chemicals for use in 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.

[0272] Additional examples related to the disclosed technology In view of the implementations described above with respect to the disclosed subject matter, this application discloses additional embodiments listed below. It should be noted that an individual feature in one embodiment, or two or more features in combination in that embodiment, and optionally in combination with one or more features in one or more further embodiments, are also further embodiments that fall within the disclosure of this application.

Example

[0273] Example 1. A quick-release suture mechanism, comprising a suture anchor cap configured to be selectively coupled to and selectively decoupled from a quick-release dock port, the quick-release suture mechanism being configured to be coupled to a suture configured to be connected to a transplantable device, the quick-release suture mechanism being configured to selectively transition between a locked configuration in which the quick-release suture mechanism maintains the suture in a fixed position relative to the quick-release dock port and an unlocked configuration in which the suture can be removed from the quick-release dock port, the quick-release suture mechanism being in the locked configuration when the suture anchor cap is operably coupled to the quick-release dock port and in the unlocked configuration when the suture anchor cap is removed from the quick-release dock port.

[0274] Example 2. The quick-release suture mechanism is configured to be coupled to a suture lock assembly including a tensioner housing, the quick-release suture mechanism including a quick-release dock port configured to be attached to a suture outlet port of the tensioner housing, the quick-release suture mechanism according to any embodiment of the present specification, particularly the quick-release suture mechanism according to Example 1.

[0275] Example 3. When the quick - release suture mechanism is in operation, the suture is configured to extend from the quick - release dock port through the suture outlet port, to continue to a transplantable device through the suture inlet port of the suture lock assembly, and further to return to the quick - release dock port via the suture inlet port and the suture outlet port. The quick - release suture mechanism described in any embodiment of this specification, particularly in embodiment 2.

[0276] Example 4. The quick - release suture mechanism is a suture lock assembly including a tensioner housing and is configured to be coupled to a suture lock assembly including a spool configured to engage the suture. The tensioner housing at least partially receives the spool. The spool is configured such that when the quick - release suture mechanism is in a locked configuration, rotating the spool relative to the tensioner housing acts to increase the tension of the suture between the suture lock assembly and the transplantable device by winding a portion of the suture around the spool. The quick - release suture mechanism described in any embodiment of this specification, particularly in any one of embodiments 1 - 3.

[0277] Example 5. The quick - release suture mechanism further includes 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. One or both of the suture anchor cap and the quick - release dock port include at least a portion of the dock port coupling mechanism. The quick - release suture mechanism described in any embodiment of this specification, particularly in any one of embodiments 1 - 4.

[0278] Example 6. The dock port coupling mechanism includes a port thread of a quick release dock port and a cap thread of a suture anchor cap, and the cap thread is configured to selectively couple the suture anchor cap to the quick release dock port by screwing engagement with the port thread, which is described in any embodiment of this specification, particularly in embodiment 5, the quick release suture mechanism.

[0279] Example 7. The dock port coupling mechanism includes a bayonet pin and a bayonet slot configured to receive the bayonet pin in a bayonet lock configuration, wherein one of the quick release dock port and the suture anchor cap includes the bayonet pin and the other of the quick release dock port and the suture anchor cap includes the bayonet slot, which is described in any embodiment of this specification, particularly in embodiment 5 or 6, the quick release suture mechanism.

[0280] Example 8. The bayonet pin includes a pin cap that is wider in diameter than the rest of the bayonet pin and terminates at the pin cap, and the suture extends between a suture fixed end and a suture free end and terminates at each of the suture fixed end and the suture free end, and the quick release suture mechanism is configured such that the suture free end wraps around the bayonet pin so that the pin cap holds the suture on the bayonet pin, which is described in any embodiment of this specification, particularly in embodiment 7, the quick release suture mechanism.

[0281] Example 9. The bayonet pin includes a lateral pin hole extending through the diameter of the bayonet pin, and the quick release suture mechanism is configured such that the suture extends through the lateral pin hole to at least partially hold the suture against the bayonet pin, which is described in any embodiment of this specification, particularly in embodiment 7 or 8, the quick release suture mechanism.

[0282] Example 10. The suture anchor cap includes an inner plug, an outer skirt surrounding the inner plug circumferentially, and an annular channel defined between the outer skirt and the inner plug. When the quick-release suture mechanism is in a locked configuration, the annular channel receives at least a portion of the quick-release dock port, whereby the inner plug is received inside the quick-release dock port and the outer skirt extends circumferentially around the quick-release dock port. The quick-release suture mechanism according to any embodiment described herein, particularly any one of Embodiments 1-9.

[0283] Example 11. The suture extends between a suture fixed end and a suture free end and terminates at each of the suture fixed end and the suture free end. The suture anchor cap includes a suture anchor position, and the suture anchor cap is configured to be operably coupled to the suture fixed end at the suture anchor position, whereby the suture fixed end is restricted from coming off the suture anchor cap during the operational use of the quick-release suture mechanism. The quick-release suture mechanism according to any embodiment described herein, particularly any one of Embodiments 1-10.

[0284] Example 12. The suture fixed end is configured to be fixedly coupled to the suture anchor position. The quick-release suture mechanism according to any embodiment described herein, particularly Example 11 described herein.

[0285] Example 13. The suture fixed 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 tie-based coupling, and a mechanical obstacle. The quick-release suture mechanism according to any embodiment described herein, particularly Example 11 or 12 described herein.

[0286] Example 14. The quick-release suture mechanism is configured such that when the quick-release suture mechanism is in a locked configuration, the free end of the suture is at least substantially fixed in a predetermined position relative to the quick-release dock port, and when the quick-release suture mechanism is in an unlocked configuration, the free end of the suture is free to move through the quick-release dock port, as described in any embodiment of this specification, particularly in any one of Embodiments 11 to 13, the quick-release suture mechanism.

[0287] Embodiment 15. The quick-release suture mechanism further includes a dock port coupling mechanism configured to selectively couple the suture anchor cap to the quick-release dock port. The dock port coupling mechanism includes a port thread of the quick-release dock port and a cap thread of the suture anchor cap. The cap thread is configured to selectively couple the suture anchor cap to the quick-release dock port by screwing engagement with the port thread. When the quick-release suture mechanism is in a locked configuration, the free end of the suture extends between the port thread and the cap thread and is locked in a predetermined position by the port thread and the cap thread, as described in any embodiment of this specification, particularly in any one of Embodiments 11 to 14, the quick-release suture mechanism.

[0288] Embodiment 16. The suture anchor cap defines an internal hole, and one or both of the fixed end and the free end of the suture extend at least partially through the internal hole, as described in any embodiment of this specification, particularly in any one of Embodiments 11 to 15, the quick-release suture mechanism.

[0289] Embodiment 17. The internal hole includes a suture anchor position, as described in any embodiment of this specification, particularly in Embodiment 16, the quick-release suture mechanism.

[0290] Embodiment 18. The suture anchor cap includes an internal plug that defines at least a portion of an internal hole, and is a quick-release suture mechanism described in any embodiment of this specification, particularly in Embodiment 16 or 17.

[0291] Embodiment 19. The internal hole is a first internal hole, the suture anchor cap further includes a second internal hole, the fixed end of the suture extends at least partially through the first internal hole, and the free end of the suture extends at least partially through the second internal hole when the quick-release suture mechanism is in a locked configuration, and is a quick-release suture mechanism described in any embodiment of this specification, particularly in any one of Embodiments 16 to 18.

[0292] Embodiment 20. The internal hole extends through the entire length of the suture anchor cap, and is a quick-release suture mechanism described in any embodiment of this specification, particularly in any one of Embodiments 11 to 19.

[0293] Embodiment 21. The internal hole extends only through a part of the length of the suture anchor cap, and is a quick-release suture mechanism described in any embodiment of this specification, particularly in any one of Embodiments 11 to 19.

[0294] Embodiment 22. The quick-release suture mechanism is configured such that when the quick-release suture mechanism is in a locked configuration, the free end of the suture extends at least substantially outside the internal hole, and is a quick-release suture mechanism described in any embodiment of this specification, particularly in any one of Embodiments 11 to 21.

[0295] Embodiment 23. The quick release dock port is configured to be attached to the suture outlet port of the tensione housing. The suture anchor cap includes an inner plug, an outer skirt surrounding the inner plug in the circumferential direction, 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, whereby the inner plug is received inside the quick release dock port, and the outer skirt extends circumferentially around the quick release dock port. The quick release suture mechanism is configured such that when the quick release suture mechanism is in the locked configuration, the free end of the suture extends from the suture outlet port through the inner hole, around the outer skirt, into the annular channel, and then again through the inner hole. The quick release suture mechanism according to any embodiment described herein, particularly any one of embodiments 11 to 22.

[0296] Example 24. The suture anchor cap includes gripping features configured to facilitate gripping of the suture anchor cap to transition the quick release suture mechanism between the locked configuration and the unlocked configuration. The quick release suture mechanism according to any embodiment described herein, particularly any one of embodiments 1 to 23.

[0297] 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 embodiment described herein, particularly as described in Example 24.

[0298] Example 26. To limit leakage from the quick release dock port, it further includes a gasket configured to form at least a substantially fluid-tight seal. The quick release suture mechanism according to any embodiment described herein, particularly any one of embodiments 1 to 25.

[0299] Example 27. The quick release suture mechanism is configured to be coupled to a suture lock assembly including 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 a locked configuration, as described in any of the embodiments herein, particularly as described in Example 26, of the quick release suture mechanism.

[0300] Example 28. The gasket is configured to form at least a substantially fluid tight seal to limit the escape of fluid from the quick release dock port when the quick release suture mechanism is in an unlocked configuration, as described in any of the embodiments herein, particularly as described in Example 26 or 27, of the quick release suture mechanism.

[0301] Example 29. The quick release dock port is configured to be attached to the suture exit port of the tensioner housing, and the gasket is received within one or both of the suture exit port and the quick release dock port, as described in any of the embodiments herein, particularly as described in any one of Examples 26 - 28, of the quick release suture mechanism.

[0302] Example 30. The quick release dock port is configured to be attached to the suture exit port of the tensioner housing, and the gasket is a suture centering member that acts to maintain the suture in the central region of the suture exit port to align the suture with the inner hole of the suture anchor cap, as described in any of the embodiments herein, particularly as described in any one of Examples 26 - 29, of the quick release suture mechanism.

[0303] Example 31. Further comprising a dock port coupling mechanism configured to selectively couple a suture anchor cap to a quick release dock port, the dock port coupling mechanism including a bayonet pin and a bayonet slot configured to receive the bayonet pin in a bayonet lock configuration, wherein one of the quick release dock port and the suture anchor cap includes the bayonet pin and the other includes the bayonet slot, and when the quick release suture mechanism is in a locked configuration, the gasket biases the suture anchor cap radially outwardly to bias the bayonet pin into engagement with the bayonet slot, the quick release suture mechanism according to any embodiment described herein, particularly any one of embodiments 26-30.

[0304] Example 32. A suture lock assembly comprising a spool configured to engage a suture configured to be connected to an implantable device and a quick release suture mechanism, the quick release suture mechanism being the quick release suture mechanism according to any one of embodiments 1-31.

[0305] Example 33. Further comprising a tensioner housing at least partially receiving the spool, the tensioner housing including a suture inlet port and a suture outlet port, the quick release suture mechanism being attached to the suture outlet port, the suture lock assembly according to any embodiment described herein, particularly embodiment 32.

[0306] Example 34. The tensioner housing includes a quick release dock port, the suture lock assembly according to any embodiment described herein, particularly embodiment 33.

[0307] Example 35. The quick release dock port and the suture outlet port are integrally formed, and are the suture lock assemblies described in any of the embodiments of this specification, particularly those described in Embodiment 33 or 34.

[0308] Embodiment 36. The suture lock assembly is configured such that the suture extends between the implantable device and the spool through the suture introduction port, and is the suture lock assembly described in any of the embodiments of this specification, particularly any one of Embodiments 33 to 35.

[0309] Embodiment 37. The suture lock assembly is configured such that the suture extends between the spool and the quick release suture mechanism through the suture outlet port, and is the suture lock assembly described in any of the embodiments of this specification, particularly any one of Embodiments 33 to 36.

[0310] Embodiment 38. The suture lock assembly is configured to be operably coupled to a delivery device configured to deliver the implantable device to a target implantation site within a patient's body, and the tensioner housing is configured to be operably coupled to the delivery device connection portion of the delivery device such that the suture extends between the spool and the implantable device through the delivery device connection portion, and is the suture lock assembly described in any of the embodiments of this specification, particularly any one of Embodiments 32 to 37.

[0311] Embodiment 39. The suture lock assembly further includes a tensioner housing that at least partially receives the spool, the tensioner housing includes a suture introduction port and a suture outlet port, the quick release suture mechanism is attached to the suture outlet port, and the suture introduction port is configured to be operably coupled to the delivery device connection portion, and is the suture lock assembly described in any of the embodiments of this specification, particularly the one described in Embodiment 38.

[0312] Embodiment 40. A suture locking assembly according to any embodiment described herein, particularly any one of embodiments 33 to 39, further comprising one or more suture centering members configured to guide a suture through a tensioner housing.

[0313] Example 41. A suture locking assembly according to any embodiment described herein, particularly the embodiment described in Example 40, wherein at least one suture centering member is configured to maintain at least a portion of the suture spaced from the inner surface of the tensioner housing.

[0314] Example 42. A suture locking assembly according to any embodiment described herein, particularly any one of embodiments 40 or 41, wherein at least one suture centering member engages the tensioner housing within a suture introduction port.

[0315] Example 43. A suture locking assembly according to any embodiment described herein, particularly any one of embodiments 40 to 42, wherein at least one suture centering member engages the tensioner housing within a suture exit port.

[0316] Example 44. A suture locking assembly according to any embodiment described herein, particularly any one of embodiments 33 to 43, wherein the spool is configured to be selectively rotated relative to the tensioner housing to selectively increase the length of suture surrounded by the tensioner housing.

[0317] Example 45. A suture locking assembly according to any embodiment described herein, particularly any one of embodiments 33 to 44, further comprising a rotor configured to be manually driven by a user to rotate the spool relative to the tensioner housing.

[0318] Example 46. The rotor is a stitch lock assembly as described in any embodiment of this specification, fixedly coupled to the spool, and in particular as described in embodiment 45.

[0319] Embodiment 47. At least a portion of the rotor extends outside the tensioner housing, and is a stitch lock assembly as described in any embodiment of this specification, and in particular as described in embodiment 45 or 46.

[0320] Embodiment 48. The rotor includes a gripping portion configured to facilitate gripping of the rotor for manually rotating the spool relative to the tensioner housing, and is a stitch lock assembly as described in any embodiment of this specification, and in particular as described in any one of embodiments 45 - 47.

[0321] Embodiment 49. The gripping portion includes one or more of a textured surface, recesses, protrusions, knobs, levers, handles, and tabs, and is a stitch lock assembly as described in any embodiment of this specification, and in particular as described in embodiment 48.

[0322] Embodiment 50. The stitch lock assembly further includes a safety handle operably coupled to the rotor and extending away from the rotor, and the safety handle covers the quick release stitch mechanism to prevent access to the quick release stitch mechanism when the rotor is in a predetermined rotational orientation relative to the tensioner housing, and is a stitch lock assembly as described in any embodiment of this specification, and in particular as described in any one of embodiments 45 - 49.

[0323] Embodiment 51. The predetermined rotational orientation corresponds to a configuration in which the spool acts to apply tension to the stitch, and is a stitch lock assembly as described in any embodiment of this specification, and in particular as described in embodiment 50.

[0324] Embodiment 52. The suture lock assembly is configured to rotate the rotor away from a predetermined rotational orientation, thereby moving the safety handle away from the quick release suture mechanism, which enables access to the suture anchor cap, as described in any embodiment of this specification, particularly in embodiments 50 or 51, the suture lock assembly.

[0325] Example 53. The suture lock assembly further includes an orientation selector configured to allow the rotor to rotate in only one direction to prevent rotation in an improper orientation, as described in any embodiment of this specification, particularly in any one of embodiments 45 to 52, the suture lock assembly.

[0326] Example 54. The orientation selector includes a ratchet mechanism, as described in any embodiment of this specification, particularly in embodiment 53, the suture lock assembly.

[0327] Example 55. The orientation selector is configured to be switched between a first mode in which the rotor is rotatable to increase the tension of the suture and rotation to decrease the tension of the suture is blocked, and a second mode in which the rotor is rotatable to decrease the tension of the suture and rotation to increase the tension of the suture is blocked, as described in any embodiment of this specification, particularly in embodiments 53 or 54, the suture lock assembly.

[0328] Example 56. The suture lock assembly further includes a cleaning port fluidly coupled to the suture introduction port, as described in any embodiment of this specification, particularly in any one of embodiments 33 to 55, the suture lock assembly.

[0329] Example 57. The tensioner housing at least partially defines the cleaning port, as described in any embodiment of this specification, particularly in embodiment 56, the suture lock assembly.

[0330] 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 lock assembly according to any one of Examples 32 to 57, the delivery device.

[0331] Example 59. A suture lock assembly, comprising a suture tensioner configured to engage a suture configured to be connected to a transplantable device, the suture tensioner being configured to be selectively rotated about a tensioner central axis for collecting the length of the suture, the suture tensioner being a pair of posts spaced apart from each other, each post being configured to rotate about the tensioner central axis when the suture tensioner rotates, the suture lock assembly including a pair of posts and a connection body coupled to each of the posts.

[0332] Example 60. Further comprising a tensioner housing at least partially receiving the suture tensioner, the suture tensioner being configured to rotate relative to the tensioner housing, the tensioner housing including a suture introduction port, whereby the suture extends between the transplantable device and the suture tensioner through the suture introduction port, the suture lock assembly according to any embodiment of the present specification, particularly according to Example 59.

[0333] Example 61. The suture lock assembly is further configured such that, during operation of the suture lock assembly, the suture extends from the suture tensioner through the suture introduction port to the transplantable device and back to the suture tensioner through the suture introduction port, the suture lock assembly according to any embodiment of the present specification, particularly according to Example 60.

[0334] Example 62. The suture tensioner is configured such that rotating the suture tensioner acts to increase the tension of the suture between the suture tensioner and the implantable device by wrapping a portion of the suture around a pair of posts, as described in any embodiment herein, particularly any one of embodiments 59 - 61, of the suture lock assembly.

[0335] Example 63. The suture lock assembly is configured such that at least a portion of the suture is fixedly coupled to one of the two posts, as described in any embodiment herein, particularly any one of embodiments 59 - 62, of the suture lock assembly.

[0336] Example 64. The suture extends between a first end and a second end and terminates at each of the first end and the 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, as described in any embodiment herein, particularly any one of embodiments 59 - 63, of the suture lock assembly.

[0337] Example 65. At least one of the two posts includes a suture anchor position, as described in any embodiment herein, particularly as described in Example 64, of the suture lock assembly.

[0338] Example 66. The suture lock assembly is configured such that the suture tensioner can be rotated to a position where the two posts are spaced apart from the suture, as described in any embodiment herein, particularly any one of embodiments 59 - 65, of the suture lock assembly.

[0339] Example 67. The tensioner housing further includes a suture outlet port, whereby the suture extends through the tensioner housing between the suture inlet port and the suture outlet port, as described in any embodiment herein, particularly in any one of embodiments 60 to 66, of the suture locking assembly.

[0340] Example 68. The suture locking assembly includes a rotor configured to be manually driven by a user to rotate the suture tensioner, as described in any embodiment herein, particularly in any one of embodiments 59 to 67, of the suture locking assembly.

[0341] Example 69. The rotor is fixedly coupled to each of the two posts, as described in any embodiment herein, particularly in embodiment 68, of the suture locking assembly.

[0342] Example 70. The rotor and the two posts are integrally formed, as described in any embodiment herein, particularly in embodiment 68 or 69, of the suture locking assembly.

[0343] Example 71. The rotor is fixedly coupled to the connection body, as described in any embodiment herein, particularly in any one of embodiments 68 to 70, of the suture locking assembly.

[0344] Example 72. The rotor includes the connection body, as described in any embodiment herein, particularly in any one of embodiments 68 to 71, of the suture locking assembly.

[0345] Example 73. The rotor includes a gripping portion configured to facilitate gripping of the rotor for manually rotating the suture tensioner, as described in any embodiment herein, particularly in any one of embodiments 68 to 72, of the suture locking assembly.

[0346] Example 74. The gripping portion includes one or more of a textured surface, a recess, a protrusion, a knob, a lever, a handle, and a tab, and is a suture lock assembly as described in any embodiment of this specification, particularly as described in Example 73.

[0347] Example 75. A suture lock assembly as described in any embodiment of this specification, particularly in any one of Examples 68 to 74, further comprising an orientation selector configured to allow the rotor to rotate only in one direction to prevent rotation in an improper orientation.

[0348] Example 76. An orientation selector includes a ratchet mechanism, and is a suture lock assembly as described in any embodiment of this specification, particularly as described in Example 75.

[0349] Example 77. The orientation selector is configured to be switched between a first mode in which the rotor is rotatable to increase the tension of the suture and rotation to decrease the tension of the suture is blocked, and a second mode in which the rotor is rotatable to decrease the tension of the suture and rotation to increase the tension of the suture is blocked, and is a suture lock assembly as described in any embodiment of this specification, particularly as described in Example 75 or 76.

[0350] Example 78. A suture lock assembly as described in any embodiment of this specification, particularly in any one of Examples 68 to 77, 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, and at least a portion of the rotor extending outside the tensioner housing.

[0351] Example 79. Further comprising a tensioner housing for at least partially receiving a suture tensioner, the suture tensioner being configured to rotate relative to the tensioner housing, and one or both of the tensioner housing and the rotor including one or more locking tabs configured to limit the rotor from disengaging from the tensioner housing, as described in any embodiment herein, particularly in any one of embodiments 68-78, suture lock assembly.

[0352] Example 80. The suture tensioner includes a release configuration in which both posts are arranged so as not to apply any force to the suture, and a full tension configuration in which both posts are arranged to engage the suture and further apply maximum tension to the suture when the suture is connected to the implantable device, and is configured to rotate so as to shift the suture tensioner between these two configurations and between a plurality of defined tensioner configurations therebetween, as described in any embodiment herein, particularly in any one of embodiments 59-79, suture lock assembly.

[0353] Example 81. The suture tensioner is configured to rotate by one or more angles less than 180 degrees, about 180 degrees, more than 180 degrees, less than 360 degrees, about 360 degrees, and more than 360 degrees in order to shift the suture tensioner between the release configuration and the full tension configuration, as described in any embodiment herein, particularly in Example 80, suture lock assembly.

[0354] Example 82. Further including one or more rotor locking portions configured to mechanically limit the rotation of the suture tensioner by engaging a part of the suture lock assembly, thereby defining one or both of the release configuration and the full tension configuration, as described in any embodiment herein, particularly in Example 80 or 81, suture lock assembly.

[0355] Example 83. 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, and one or more rotor locking portions being fixed at a predetermined position relative to the tensioner housing, the suture locking assembly according to any embodiment described herein, particularly the embodiment described in Example 82.

[0356] Example 84. Further comprising a rotor configured to be manually driven by a user to rotate the suture tensioner relative to the tensioner housing, and at least one of the one or more rotor locking portions being configured to engage the rotor to define one or both of a release configuration and a full tension configuration, the suture locking assembly according to any embodiment described herein, particularly the embodiment described in Example 83.

[0357] Example 85. At least one of the one or more rotor locking portions 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, the suture locking assembly according to any embodiment described herein, particularly any one of the embodiments described in Examples 82 - 84.

[0358] Example 86. Further comprising an indicator configured to provide a visual indication regarding the configuration of the tensioner, the suture locking assembly according to any embodiment described herein, particularly any one of the embodiments described in Examples 80 - 85.

[0359] Example 87. A tensioner housing that at least partially receives a suture tensioner, and a rotor configured to be manually driven by a user to rotate the suture tensioner relative to the tensioner housing, and wherein one or both of the rotor and the tensioner housing includes at least a portion of an indicator, a suture lock assembly according to any embodiment described herein, particularly as described in embodiment 86.

[0360] Example 88. An indicator configured to provide an indication that the suture tensioner is in one or both of a released configuration and a full tension configuration, a suture lock assembly according to any embodiment described herein, particularly as described in embodiment 86 or 87.

[0361] Example 89. An 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 are aligned when the suture tensioner is in one or both of a released configuration and a full tension configuration, a suture lock assembly according to any embodiment described herein, particularly as described in any one of embodiments 86-88.

[0362] Example 90. Further includes a tensioner housing that at least partially receives a suture tensioner, the suture tensioner is configured to rotate relative to the tensioner housing, the tensioner housing includes a suture introduction port, whereby the suture extends between the implantable device and the suture tensioner via the suture introduction port, the tensioner housing further includes a suture outlet port, whereby the suture extends through the tensioner housing between the suture introduction port and the suture outlet port, and when the suture tensioner is in a released configuration, one or both of the two posts are spaced from a straight line connecting the suture introduction port and the suture outlet port, a suture lock assembly according to any embodiment described herein, particularly as described in any one of embodiments 80-89.

[0363] 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 including a suture introduction port, whereby the suture extends between the implantable device and the suture tensioner via the suture introduction port, the tensioner housing further including a suture exit port, whereby the suture extends through the tensioner housing between the suture introduction port and the suture exit port, and when the suture tensioner is in a released configuration, one or both of the two posts are tangential to a straight line connecting the suture introduction port and the suture exit port, a suture locking assembly according to any embodiment herein, particularly according to any one of Embodiments 80-90.

[0364] Example 92. 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 including a tensioner chamber that surrounds at least a portion of the two posts and a portion of the suture, and when the suture tensioner is in a released configuration, the suture freely occupies the area of the tensioner chamber between the two posts without being obstructed by a portion of the suture tensioner, a suture locking assembly according to any embodiment herein, particularly according to any one of Embodiments 80-91.

[0365] Example 93. Further comprising a rotor configured to be manually driven by a user to rotate the suture tensioner, and a rotor locking mechanism configured to limit the rotor from rotating away from one or more predetermined configurations, a suture locking assembly according to any embodiment herein, particularly according to any one of Embodiments 59-92.

[0366] Example 94. The suture tensioner is configured to rotate so as to transition the suture tensioner between a plurality of tensioner configurations defined between a release configuration in which both posts are arranged so as not to apply any force to the suture and a full tension configuration in which both posts are arranged to apply a maximum tension to the suture so as to engage the suture when the suture is connected to the implantable device. The rotor lock mechanism is configured to limit the rotor from rotating away from the full tension state. A suture lock assembly according to any embodiment described herein, particularly embodiment 93.

[0367] Example 95. Further including a tensioner housing that at least partially receives the suture tensioner, the rotor includes a rotor lock channel, the tensioner housing includes a rotor lock protrusion extending into the rotor lock channel, and the rotor lock mechanism includes the rotor lock channel and the rotor lock protrusion. A suture lock assembly according to any embodiment described herein, particularly embodiment 93 or 94.

[0368] Example 96. Rotating the rotor relative to the tensioner housing acts to move the rotor lock channel relative to the rotor lock protrusion. A suture lock assembly according to any embodiment described herein, particularly embodiment 95.

[0369] Example 97. The rotor includes a detent that increases the radius of the rotor lock channel to partially limit the rotation of the rotor relative to the tensioner housing. A suture lock assembly according to any embodiment described herein, particularly embodiment 95 or 96.

[0370] Example 98. The rotor lock channel includes a lock projection receiving member that receives a rotor lock projection therein when the rotor rotates to a position corresponding to a complete tension configuration, and the detent partially defines the lock projection receiving member, the suture lock assembly according to any embodiment of the present specification, particularly according to embodiment 97.

[0371] Example 99. Each post has one or more of a cylindrical, conical, and frustoconical shape, the suture lock assembly according to any embodiment of the present specification, particularly according to any one of embodiments 59 to 98.

[0372] Example 100. Each post has a cross-sectional shape of one or more of a curved shape, a circular shape, an oval shape, an elliptical shape, and a yin-yang shape, the suture lock assembly according to any embodiment of the present specification, particularly according to any one of embodiments 59 to 99.

[0373] Example 101. A pair of posts are at least substantially identical to each other, the suture lock assembly according to any embodiment of the present specification, particularly according to any one of embodiments 59 to 100.

[0374] Example 102. Each post includes a suture engaging surface that engages the suture during operation of the suture lock assembly, the suture lock assembly according to any embodiment of the present specification, particularly according to any one of embodiments 59 to 101.

[0375] Example 103. The suture tensioner is configured such that the suture slides against each suture engaging surface when the suture tensioner rotates, the suture lock assembly according to any embodiment of the present specification, particularly according to embodiment 102.

[0376] Example 104. The suture tensioner is configured such that the suture remains in static contact with each suture engagement surface as the suture tensioner rotates, as described in any embodiment of this specification, particularly in embodiments 102 or 103, of the suture lock assembly.

[0377] Example 105. The suture tensioner includes a pair of rollers, each roller being rotatably coupled to a corresponding post, each roller including a corresponding suture engagement surface, and each roller being configured to maintain the suture in static contact with the corresponding suture engagement surface as the suture tensioner rotates by rotating with respect to the corresponding post, as described in any embodiment of this specification, particularly in any one of embodiments 102 to 104, of the suture lock assembly.

[0378] Example 106. Each post includes a front edge and a rear edge, and the suture engagement surface extends between the front edge and the rear edge, as described in any embodiment of this specification, particularly in any one of embodiments 102 to 105, of the suture lock assembly.

[0379] Example 107. Each post has a greater width at the front edge of the post than at the rear edge of the post, as measured along a direction perpendicular to the tensioner central axis and along a direction intersecting the tensioner central axis, as described in any embodiment of this specification, particularly in embodiment 106, of the suture lock assembly.

[0380] Example 108. Each post is rotatably coupled to a connection body, as described in any embodiment of this specification, particularly in any one of embodiments 59 to 107, of the suture lock assembly.

[0381] Example 109. The suture lock 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. The tensioner housing is configured to be operably coupled to the delivery device connection such that the suture extends between the suture tensioner and the implantable device via the delivery device connection of the delivery device. The suture lock assembly according to any embodiment described herein, particularly any one of embodiments 60-108.

[0382] Example 110. The suture introduction port is configured to be operably coupled to the delivery device connection. The suture lock assembly according to any embodiment described herein, particularly embodiment 109 described herein.

[0383] Example 111. The suture lock assembly according to any embodiment described herein, particularly any one of embodiments 60-110, further includes one or more suture centering members configured to guide the suture through the tensioner housing.

[0384] Example 112. The suture lock assembly according to any embodiment described herein, particularly embodiment 111 described herein, wherein at least one suture centering member is configured to maintain at least a portion of the suture spaced from the inner surface of the tensioner housing.

[0385] Example 113. The suture lock assembly according to any embodiment described herein, particularly embodiments 111 or 112 described herein, wherein at least one suture centering member engages the tensioner housing within the suture introduction port.

[0386] Example 114. The tensioner housing further includes a suture outlet port, whereby the suture extends through the tensioner housing between the suture inlet port and the suture outlet port, and at least one suture centering member engages the tensioner housing within the suture outlet port, a suture locking assembly according to any embodiment described herein, particularly any one of embodiments 111-113.

[0387] Example 115. A suture locking assembly according to any embodiment described herein, particularly any one of embodiments 60-114, further including a cleaning port fluidly coupled to the suture inlet port.

[0388] Example 116. A suture locking assembly according to any embodiment described herein, particularly embodiment 115, wherein the tensioner housing at least partially defines the cleaning port.

[0389] Example 117. A suture locking assembly according to any embodiment described herein, particularly embodiments 115 or 116, wherein the tensioner housing includes a tensioner chamber surrounding a portion of the suture, and the cleaning port is fluidly coupled to the suture inlet port via the tensioner chamber.

[0390] Example 118. The tensioner housing further includes a suture outlet port, whereby 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 a quick-release suture mechanism according to any one of embodiments 1-31, a suture locking assembly according to any embodiment described herein, particularly any one of embodiments 60-117.

[0391] Example 119. A suture lock assembly housing that operably couples a suture tensioner and a quick release suture mechanism to each other, further comprising the suture lock assembly described in any embodiment of this specification, particularly in embodiment 118.

[0392] Example 120. The suture lock assembly housing includes a first conduit configured to receive the sleeve shaft of the delivery device and a second conduit branched from the first conduit, and the suture extends to the suture tensioner through the second conduit. The suture lock assembly described in any embodiment of this specification, particularly in embodiment 119.

[0393] Example 121. The suture lock assembly housing includes an inner housing and an outer housing that at least substantially surrounds the inner housing. The suture lock assembly described in any embodiment of this specification, particularly in embodiment 119 or 120.

[0394] Example 122. The inner housing includes a first conduit configured to receive the sleeve shaft of the delivery device and a second conduit branched from the first conduit, and the suture extends to the suture tensioner through the second conduit. The suture lock assembly described in any embodiment of this specification, particularly in embodiment 121.

[0395] Example 123. The outer housing includes an upper outer housing portion and a lower outer housing portion, and the upper outer housing portion and the lower outer housing portion are configured to at least substantially surround the inner housing by being assembled to each other on both sides of the inner housing. The suture lock assembly described in any embodiment of this specification, particularly in embodiment 121 or 122.

[0396] Example 124. The inner housing includes a rotor receiving member that receives at least a portion of the suture tensioner, a suture locking assembly according to any embodiment described herein, particularly according to any one of Embodiments 121 to 123.

[0397] Embodiment 125. The suture locking assembly includes a rotor configured to be manually driven by a user to rotate the suture tensioner, and the inner housing includes one or more locking tabs configured to limit the rotor from disengaging from the rotor receiving member, a suture locking assembly according to any embodiment described herein, particularly according to any one of Embodiments 121 to 124.

[0398] Embodiment 126. The quick release suture mechanism is sterilized, a quick release suture mechanism according to any embodiment described herein, particularly according to any one of Embodiments 1 to 31.

[0399] Embodiment 127. A method comprising sterilizing a quick release suture mechanism according to any one of Embodiments 1 to 31.

[0400] Embodiment 128. The suture locking assembly is sterilized, a suture locking assembly according to any embodiment described herein, particularly according to any one of Embodiments 32 to 57 and according to any one of Embodiments 69 to 125.

[0401] Embodiment 129. A method comprising sterilizing a suture locking assembly according to any one of Embodiments 32 to 57 and according to any one of Embodiments 59 to 125.

[0402] Embodiment 130. The delivery device is sterilized, a delivery device according to any embodiment described herein, particularly according to Embodiment 58.

[0403] Example 131. A method comprising sterilizing the delivery device described in Example 130.

[0404] For any example, each feature described herein can be combined with any one or more other features described in any one or more other examples, unless otherwise stated. For example, any one or more features in a quick-release suture mechanism can be combined with any one or more features in another quick-release suture mechanism. As another example, any one or more features in a suture lock assembly can be combined with any one or more features in another suture lock assembly and / or with any one or more features in a quick-release suture mechanism. Additionally, any one or more features in a delivery device can be combined with any one or more features in another delivery device, with one or more features in a suture lock assembly, and / or with one or more features in a quick-release suture mechanism.

[0405] Considering the many possible aspects to which the principles of the present disclosure may be applied, it will be appreciated 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 as limiting 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 quick-release suture mechanism (302, 302a, 302b, 302c, 302d, 302e) for a suture lock assembly of a delivery device for delivering an artificial implant into a patient's body, The system includes a suture anchor cap (320) configured to selectively connect to and to a quick-release dock port (304), The quick-release suture mechanism (302, 302a, 302b, 302c, 302d, 302e) is configured to connect to a suture (236) that is configured to connect to an implantable device. 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 quick-release dock port (304) and an unlocking configuration that allows the suture (236) to be removed from the quick-release dock port (304). The quick-release suture mechanism (302, 302a, 302b, 302c, 302d, 302e) is in the locked configuration 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 unlocked 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 configured to be coupled to a suture lock assembly (400, 400a, 400b, 400c, 400d) including a tensioner housing (450, 450a, 450b, 450c, 450d), and the quick-release suture mechanism (302, 302a, 302b, 302c, 302d, 302e) includes a quick-release dock port (304) configured to be attached to a suture discharge port (454, 454a) of the tensioner housing (450, 450a, 450b, 450c, 450d).

2. The suture (236) extends between the suture fixed end (237) and the suture free end (238), and terminates at the respective points of the suture fixed end (237) and the suture free end (238). The suture anchor cap (320) includes the suture anchor position (326), and the suture anchor cap (320) is located at the suture anchor position (326) and the suture fixed end (23 The quick-release suture mechanism (302, 302a, 302b, 302c, 302d, 302e) according to claim 1, wherein the suture fixing end (237) is configured to be operably coupled to (7), thereby preventing it from detaching from the suture anchor cap (320) when the quick-release suture mechanism (302, 302a, 302b, 302c, 302d, 302e) is in operation.

3. The quick-release suture mechanism (302, 302a, 302b, 302c, 302d, 302e) is When the quick-release suture mechanism (302, 302a, 302b, 302c, 302d, 302e) is configured as the locking mechanism, the free end of the suture (238) is at least substantially fixed to a predetermined position relative to the quick-release dock port (304), and The quick-release suture mechanism (302, 302a, 302b, 302c, 302d, 302e) according to claim 2, wherein when the quick-release suture mechanism (302, 302a, 302b, 302c, 302d, 302e) is configured to be unlocked, the free end of the suture (238) is configured to move freely through the quick-release dock port (304).

4. The aforementioned quick-release dock port (304) and, The present invention further includes a dock port coupling mechanism (310, 310e) configured to selectively connect the suture anchor cap (320) to the quick-release dock port (304), The dock port coupling mechanism (310, 310e) includes the port thread (312) of the quick-release dock port (304) and the cap thread (322) of the suture anchor cap (320), wherein the cap thread (322) is configured to selectively couple the suture anchor cap (320) to the quick-release dock port (304) by screw-engaging with the port thread (312), and the quick-release suture mechanism (302, 302a, 302b, 30 The quick-release suture mechanism (302, 302a, 302b, 302c, 302d, 302e) according to claim 2, wherein when the quick-release suture mechanism (302, 302a, 302b, 302c, 302d, 302e) is configured as the locking configuration, the free end of the suture (238) extends between the port thread (312) and the cap thread (322) and is locked in a predetermined position by the port thread (312) and the cap thread (322).

5. The quick-release suture mechanism (302, 302a, 302b, 302c, 302d, 302e) according to claim 2, wherein the suture anchor cap (320) defines an internal hole (330), and one or both of the suture fixed end (237) and the suture free end (238) extend at least partially through the internal hole (330).

6. The quick-release suture mechanism (302, 302a, 302b, 302c, 302d, 302e) according to claim 5, wherein the internal hole (330) includes the suture anchor position (326).

7. The suture anchor cap (320) is, Internal plug (332), The outer skirt (334) surrounds the internal plug (332) in the circumferential direction, The outer skirt (334) and the inner plug (332) are defined to include an annular channel (336), When the quick-release suture mechanism (302, 302a, 302b, 302c, 302d, 302e) is configured as the locking mechanism, the annular channel (336) receives at least a portion of the quick-release dock port (304) such that the internal plug (332) is received inside the quick-release dock port (304) and the outer skirt (334) extends circumferentially around the quick-release dock port (304), and the internal plug (332) defines at least a portion of the internal hole (330), according to claim 5.

8. The quick-release suture mechanism (302, 302a, 302b, 302c, 302d, 302e) according to claim 5, wherein the internal hole (330) extends through the entire length of the suture anchor cap (320).

9. The quick-release suture mechanism (302, 302a, 302b, 302c, 302d, 302e) according to claim 5, wherein the internal hole (330) extends through only a portion of the length of the suture anchor cap (320).

10. The aforementioned quick-release dock port (304) and, The present invention further includes a dock port coupling mechanism (310, 310e) configured to selectively connect the suture anchor cap (320) to the quick-release dock port (304), The dock port coupling mechanism (310, 310e) includes a bayonet pin (314e) and bayonet slots (324, 324e) configured to receive the bayonet pin (314e) in a bayonet lock configuration, wherein one of the quick-release dock port (304) and the suture anchor cap (320) includes the bayonet pin (314e), and the other of the quick-release dock port (304) and the suture anchor cap (320) includes the bayonet slots (324, 324e), as described in claim 2 (302, 302a, 302b, 302c, 302d, 302e).

11. A suture lock assembly (400, 400a, 400b, 400c, 400d), A spool (340) configured to engage with a suture (236) configured to be connected to an implantable device, A quick-release suture mechanism (302, 302a, 302b, 302c, 302d, 302e) according to any one of claims 1 to 10, configured to bind to the suture (236), is included, The quick-release suture mechanism (302, 302a, 302b, 302c, 302d, 302e) is A quick-release dock port (304) is configured to be attached to the suture outlet ports (454, 454a), The dock port coupling mechanism (310, 310e) is configured to selectively connect the suture anchor cap (320) to the quick-release dock port (304), In the lock configuration, the quick-release suture mechanism (302, 302a, 302b, 302c, 302d, 302e) maintains the suture (236) in a fixed position relative to the suture outlet port (454, 454a), and in the unlock configuration, the suture (236) can be removed from the suture outlet port (454, 454a). The dock port coupling mechanism (310, 310e) includes the port thread (312) of the quick-release dock port (304) and the cap thread (322) of the suture anchor cap (320), The suture lock assembly (400, 400a, 400b, 400c, 400d) is configured such that the cap threads (322) engage with the port threads (312) to selectively connect the suture anchor cap (320) to the quick-release dock port (304).

12. The system further includes a tensioner housing (450, 450a, 450b, 450c, 450d) that at least partially receives the spool (340), the tensioner housing (450, 450a, 450b, 450c, 450d) including a suture introduction port (452, 452a) and a suture exit port (454, 454a), the quick-release suture mechanism (302, 302a, 302b, 302c, 302d, 302e) mounted to the suture exit port (454, 454a), and the suture lock assembly (400, 400a, 400b, 400c, 400d) the suture The suture lock assembly (400, 400a, 400b, 400c, 400d) according to claim 11, configured such that when the lock assembly (400, 400a, 400b, 400c, 400d) is in operation, the suture (236) extends from the quick-release dock port (304) through the suture exit port (454, 454a), continues through the suture introduction port (452, 452a) to the implantable device, and further returns to the quick-release dock port (304) via the suture introduction port (452, 452a) and the suture exit port (454, 454a).

13. The suture (236) extends between the suture fixed end (237) and the suture free end (238), and terminates at the respective points of the suture fixed end (237) and the suture free end (238). The suture anchor cap (320) includes the suture anchor position (326), and the suture anchor cap (320) is configured to be fixedly connected to the suture fixed end (237) at the suture anchor position (326). As a result, the suture fixed end (237) is fixed when the quick-release suture mechanism (302, 302a, 302b, 302c, 302d, 302e) is in operation. The suture lock assembly (400, 400a, 400b, 400c, 400d) according to claim 11, wherein the suture lock assembly (400, 400a, 400b, 400c, 400d) is configured such that when the quick-release suture mechanism (302, 302a, 302b, 302c, 302d, 302e) is configured as the lock configuration, the free end of the suture (238) extends between the port thread (312) and the cap thread (322) and is locked in a predetermined position by the port thread (312) and the cap thread (322).

14. The suture lock assembly (400, 400a, 400b, 400c, 400d) according to claim 13, wherein the suture anchor cap (320) defines an internal hole (330), and the suture fixing end (237) extends at least partially through the internal hole (330) when the quick-release suture mechanism (302, 302a, 302b, 302c, 302d, 302e) is configured as either the lock configuration or the unlock configuration.

15. The suture lock assembly (400, 400a, 400b, 400c, 400d) according to claim 14, wherein the free end of the suture (238) extends to the outside of the internal hole (330) when the quick-release suture mechanism (302, 302a, 302b, 302c, 302d, 302e) is configured as the lock.

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