Clips and Assemblies for Repairing Heart Valves

Abstract

To provide leaflet clips, devices and methods for introducing leaflet clips into a heart valve.SOLUTION: A leaflet clip has an elongated member including a proximal end portion and a distal end portion, and first and second clipping arms movable between an open position and a closed position. The clipping arms include respective proximal end portions coupled to the proximal end portion of the elongated member, and respective distal end portions extending distally and radially outward relative to the elongated member. The leaflet clip further includes a tubular member coaxially disposed about the elongated member. Axial motion of the tubular member relative to the elongated member or axial motion of the elongated member relative to the tubular member causes corresponding movement of the clipping arms between the open and closed positions.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present disclosure relates to devices and methods for treating heart valve insufficiency. [Background technology]

[0002] Heart valve insufficiency typically involves the regurgitation of blood through a heart valve that fails to close completely or properly, resulting in cardiovascular dysfunction. Valve regurgitation can affect, for example, the mitral, aortic, or tricuspid valve and can be associated with calcified or prolapsed leaflets and / or dilated or deformed valve annuli. One method of treating heart valve insufficiency is to improve the coaptation of the native valve leaflets using one or more leaflet clips. However, conventional leaflet clips are difficult to implant, can interfere with or damage the function of associated valve structures, such as chordae tendineae, and are often limited to use with a single type of heart valve. Therefore, improvements to devices and methods for treating heart valve insufficiency are desirable. [Prior art documents] [Patent documents]

[0003] [Patent Document 1] U.S. Patent Application Publication No. 2014 / 0067052 Summary of the Invention [Means for solving the problem]

[0004] Some embodiments of the present disclosure relate to leaflet clips and devices and methods for introducing the leaflet clip into a heart valve. In one exemplary embodiment, the leaflet clip comprises an elongate member including a proximal end portion and a distal end portion, and first and second clipping arms movable between an open position and a closed position. The clipping arms include respective proximal end portions coupled to the proximal end portion of the elongate member and respective distal end portions extending distally and radially outward relative to the elongate member. The leaflet clip further comprises a tubular member coaxially disposed about the elongate member. Axial movement of the tubular member relative to the elongate member or relative to the tubular member causes corresponding movement of the clipping arms between the open position and the closed position.

[0005] In another exemplary embodiment, a method positions a leaflet clip adjacent a commissure of a heart valve such that a first clipping arm is adjacent a first leaflet of the heart valve and a second clipping arm is adjacent a second leaflet of the heart valve, and an elongated member is positioned between the leaflets, the method further including moving a sheath coaxially disposed over the elongated member in a distal direction relative to the elongated member, or moving the elongated member proximally relative to the sheath such that the sheath moves the clipping arms from an open position to a closed position, thereby capturing the first leaflet between the first clipping arm and the elongated member and capturing the second leaflet between the second clipping arm and the elongated member.

[0006] The above and other objects, features and advantages of the present disclosure will become apparent from the following detailed description which proceeds with reference to the accompanying drawings. [Brief explanation of the drawings]

[0007] [Figure 1] 1A-1C are perspective views of an exemplary embodiment of a leaflet clip. [Figure 2] 2 is a partial exploded view of the leaflet clip of FIG. 1 with the clipping arms in an open position. [Figure 3] 2 is a perspective view of the leaflet clip of FIG. 1 with the clipping arms in a closed position. [Figure 4] 2 is a perspective view of an exemplary embodiment of a delivery system that can be used in combination with the leaflet clip of FIG. 1. [Figure 5] FIG. 5 is an exploded view of the delivery system of FIG. 4. [Figure 6] FIG. 1 illustrates one embodiment of an actuator conduit. [Figure 7] FIG. 1 illustrates one embodiment of an actuator conduit. [Figure 8] 7 illustrates one embodiment of an outer conduit disposed coaxially around the actuator conduit of FIG. 6. [Figure 9] 10A-10C illustrate an embodiment of a tubular member positioned distally around an elongate member. [Figure 10] 10A-10C illustrate an embodiment of a tubular member positioned distally around an elongate member. [Figure 11] FIG. 1 is a cross-sectional plan view of a heart valve having three leaflet clips implanted therein. [Figure 12] 1 is a schematic diagram of a heart valve showing a reduction in the diameter of the annulus. [Figure 13] FIG. 1 is a side view of a leaflet clip positioned within a heart valve with the clipping arms in an open position. [Figure 14] 9 is a side view of the leaflet clip of FIG. 8 with the clipping arms in a closed position. [Figure 15] FIG. 1 is a schematic plan view of a heart valve showing the distances between reference points on the walls of the annulus. [Figure 16] FIG. 1 is a cross-sectional plan view of a heart valve showing the distance between reference points on the annulus wall before implantation of the leaflet clips. [Figure 17] 12 is a cross-sectional plan view of the heart valve of FIG. 11 showing the reduction in diameter of the annulus after implantation of the leaflet clips. [Figure 18] FIG. 1C is a cross-sectional view of the ventricular side of the aortic valve showing the implantation of the support ring on the three leaflet clips. [Figure 19] FIG. 14 is a cross-sectional view of the aortic side of the valve of FIG. 13 showing the reduction of the diameter of the annulus using leaflet clips and a support ring. [Figure 20]1A-1C illustrate implantation of leaflet clips into the mitral valve. [Figure 21] 1A-1C illustrate implantation of leaflet clips into the mitral valve. [Figure 22] 1A-1C illustrate implantation of leaflet clips into the tricuspid valve. [Figure 23] 1A-1C illustrate implantation of leaflet clips into the tricuspid valve. [Figure 24] 1A-1C illustrate various exemplary configurations of clipping arms of a leaflet clip. [Figure 25] 1A-1C illustrate various exemplary configurations of clipping arms of a leaflet clip. [Figure 26] 1A-1C illustrate various exemplary configurations of clipping arms of a leaflet clip. [Figure 27] 1A-1C illustrate various exemplary configurations of clipping arms of a leaflet clip. [Figure 28] 1A-1C illustrate various exemplary configurations of clipping arms of a leaflet clip. [Figure 29] 1A-1C illustrate various exemplary configurations of clipping arms of a leaflet clip. [Figure 30] 1A-1C illustrate various exemplary configurations of clipping arms of a leaflet clip. [Figure 31] 1A-1C illustrate various exemplary configurations of clipping arms of a leaflet clip. [Figure 32] 1A-1C illustrate various exemplary configurations of clipping arms of a leaflet clip. [Figure 33] 10A-10C show another embodiment of a leaflet clip including a passive leaflet engagement mechanism. [Figure 34] 10A-10C illustrate the movement of the leaflets of the heart valve relative to the clipping arms of the leaflet clip as the clipping arms are moved from an open position to a closed position. [Figure 35] FIG. 10 is a side view of another embodiment of a leaflet clip with a movable and expandable covering shown in a distal position. [Figure 36]27 is a side view of the leaflet clip of FIG. 26 showing the active leaflet engagement mechanism in a proximal position in an expanded configuration. [Figure 37] 10 is a side view of another embodiment of a leaflet clip with an active leaflet engagement mechanism including multiple protrusions. [Figure 38] 10 is a side view of another embodiment of a leaflet clip with an active leaflet engagement mechanism including multiple protrusions. [Figure 39] 10A-10C illustrate an embodiment of a leaflet clip coupled to a delivery system, with the clipping arms of the leaflet clip extending distally relative to the delivery system. [Figure 40] 10A-10C illustrate an embodiment of a leaflet clip coupled to a delivery system, with the clipping arms of the leaflet clip extending proximally relative to the delivery system. [Figure 41] 10A-10C show another embodiment of a leaflet clip coupled to a delivery system, where the clipping arms of the leaflet clip extend proximally relative to the delivery system. [Figure 42] 10A-10C show another embodiment of a leaflet clip including a tissue collection region. [Figure 43] 10A-10C show another embodiment of a leaflet clip including a tissue collection region. [Figure 44] 43A-43C are diagrams illustrating the function of the tissue collection area of ​​the leaflet clip of FIG. 42. [Figure 45] 43A-43C are diagrams illustrating the function of the tissue collection area of ​​the leaflet clip of FIG. 42. [Figure 46] FIG. 44 shows the leaflet clip of FIGS. 42 and 43 with the clipping arms in a closed position and the leaflet positioned in a tissue collection area. [Figure 47] 10A-10C show another embodiment of a leaflet clip comprising a helical member disposed within a tubular central member. [Figure 48] 10A-10C show another embodiment of a leaflet clip comprising a helical member disposed around a clipping arm. [Figure 49]FIG. 10 is a perspective view of another embodiment of a delivery system that can be used in combination with any of the leaflet clips described herein. [Figure 50] FIG. 50 is an enlarged view of a distal end portion of the delivery system of FIG. 49. DETAILED DESCRIPTION OF THE INVENTION

[0008] For purposes of description, certain aspects, advantages, and novel features of embodiments of the present disclosure are disclosed herein. The disclosed methods, devices, and systems should not be construed as limiting in any way. Rather, the present disclosure is directed to all novel and non-obvious features and aspects of the various disclosed embodiments, alone and in various combinations and subcombinations with each other. The methods, devices, and systems are not limited to any particular aspect or feature or combination thereof, nor do the disclosed embodiments require that any one or more particular advantages be present or problems be solved.

[0009] It is understood that a feature, integer, property, compound, chemical moiety, or group described in connection with a particular aspect, embodiment, or example is applicable to any other aspect, embodiment, or example described herein, unless inconsistent. All features disclosed in this specification (including any accompanying claims, abstract, and drawings), and / or all steps of any method or process so disclosed, can be combined in any combination, except combinations in which at least some of such features and / or steps are mutually exclusive. The invention is not limited to the details of any disclosed embodiment. The invention extends to any novel one or any novel combination of features disclosed in this specification (including any accompanying claims, abstract, and drawings), or any novel one or any novel combination of steps of any method or process so disclosed.

[0010] Although some operations of the disclosed methods are described in a particular order for convenience of presentation, this description should be understood to encompass reordering unless a specific order is required by specific wording set forth below. For example, operations described sequentially may, in some cases, be reordered or performed simultaneously. Moreover, for simplicity, the accompanying figures may not show the various ways in which the disclosed methods can be used in conjunction with other methods. In addition, the description sometimes uses terms such as "provide" or "achieve" to describe the disclosed methods. These terms are highly abstractions of the actual operations that are performed. The actual operations that correspond to these terms may vary depending on the particular implementation and are readily discernible by those skilled in the art.

[0011] As used in this application and the claims, the singular forms "a," "an," and "the" include the plural forms unless the context clearly dictates otherwise. Furthermore, the term "include" means "comprises." Furthermore, the terms "coupled" and "associated" generally mean electrically, electromagnetically, and / or physically (e.g., mechanically or chemically) coupled or connected, and do not exclude the presence of intermediate elements between coupled or associated items unless specifically phrased otherwise.

[0012] As used herein, the term "proximal" refers to a position, direction, or portion of a device that is closer to the user and farther from the implantation site. As used herein, the term "distal" refers to a position, direction, or portion of a device that is farther from the user and closer to the implantation site. Thus, for example, proximal movement of a device is movement of the device toward the user, while distal movement of the device is movement of the device away from the user. The terms "longitudinal" and "axial," unless expressly defined otherwise, refer to axes extending in the proximal and distal directions.

[0013] As used herein, the terms "integrally formed" and "unitary structure" refer to a structure that does not include any welds, fasteners, or other means for securing separately formed materials together.

[0014] 1-3 show a representative embodiment of a leaflet clip 100 including a central elongate member or shaft 102, a first clipping arm 104 and a second clipping arm 106, and a tubular member 108 (also referred to as a "cover" or "sheath") coaxially disposed over the elongate member 102. The elongate member 102 can have a proximal end portion 110 and a distal end portion 112 and can define a lumen 114 (shown in phantom in FIG. 1) through which a guidewire can be inserted.

[0015] The clipping arms 104, 106 can be coupled to the proximal end portion 110 of the elongate member and can be movable between an open position ( FIGS. 1 and 2 ) and a closed position ( FIG. 3 ). In the embodiment shown, the clipping arms 104, 106 extend distally from the proximal end portion 110 of the elongate member and can be shaped to curve radially away from the elongate member 102 when in the open position. In some embodiments, the clipping arms 104, 106 can have a curved cross-sectional profile (in a plane perpendicular to the longitudinal axis of the elongate member 102) such that they are substantially coplanar with the elongate member 102 when in the closed position.

[0016] As shown in FIG. 2 , the clipping arms 104, 106 can extend from an annular collar 116 that is coaxially positioned on the proximal end portion 110 of the elongate member 102. In some embodiments, the clipping arms 104, 106 can be integrally formed with the collar 116 or formed separately and attached to the collar 116, as desired. For example, in some embodiments, the clipping arms 104, 106 can be hinged. As described further below, the annular collar 116 can include one or more radially extending protrusions or tabs 118 extending from the collar 116 and configured to prevent rotation of the tubular member 108 relative to the elongate member 102 (i.e., to “index” the tubular member 108). In some embodiments, the clipping arms 104, 106 and / or the collar 116 can be made from any biocompatible material, such as, for example, titanium, nickel titanium or nitinol, plastic, stainless steel, etc.

[0017] The tubular member 108 can be coaxially disposed over the elongate member 102 and can be axially movable relative to the elongate member 102 between a first position ( FIG. 1 ) and a second position ( FIG. 3 ), as indicated by arrow 127 in FIG. 1. Referring to FIG. 2 , the tubular member 108 can include a proximal end portion 120 and first and second extension portions 122, 124 corresponding to the first and second clipping arms 104, 106. The tubular member 108 can also define a slot 126 between the extension portions 122, 124 that can receive the tab 118 of the collar 116 when the tubular member 108 is in the second position, as shown in FIG. 3 . In this manner, the tubular member 108 moves distally from the first position to the second position, the tabs 118 can advance within their respective slots 126, and the first extension portion 122 and the second extension portion 124 can contact the first clipping arm 104 and the second clipping arm 106, respectively, and press the clipping arms 104, 106 into the closed position.

[0018] The clipping arms 104, 106 and the elongated member 102 can define respective leaflet receiving areas configured to receive the leaflets of the heart valve when the clipping arms 104, 106 are in the open position. As shown in Figures 1 and 2, for example, the first clipping arm 104 and the elongated member 102 can define a first leaflet receiving area 128, and the second clipping arm 106, in conjunction with the elongated member 102, can define a second leaflet receiving area 130. During implantation, the leaflet clip 100 can be positioned adjacent the commissures of the heart valve such that one leaflet is received in the first leaflet receiving area 128 and a corresponding leaflet is received in the second leaflet receiving area 130, while the elongated member 102 extends between the leaflets. In this manner, when the clipping arms 104, 106 are moved from the open position to the closed position, the valve leaflets can be captured between the first clipping arm 104 and the second clipping arm 106, respectively, and the elongated member 102, as described below.

[0019] In some embodiments, the proximal end portion 110 of the elongate member 102 can include a locking or retaining mechanism 132 for retaining the tubular member 108 in the second position. In the embodiment shown, the retaining mechanism 132 can comprise a protrusion 134 located on the proximal end of the elongate member 102. The protrusion 134 can have a diameter greater than that of the tubular member 108 such that when the proximal end portion 120 of the tubular member 108 is advanced over the protrusion 134, the protrusion 134 causes the proximal end portion 120 to expand beyond its original diameter. When the proximal end portion 120 of the tubular member 108 is advanced distally of the protrusion 134, the proximal end portion 120 can return to its original (undeformed and unexpanded) diameter, whereby the protrusion 134 restrains the tubular member 108 from moving proximally beyond the protrusion 134, thereby locking the clipping arms 104, 106 in the closed position.

[0020] In this manner, once the leaflet clip 100 is positioned in a desired location relative to the leaflets of the heart valve, the tubular member 108 can be fully advanced to a second position, locking the tubular member 108 distal to the protrusions 134, thereby locking the clipping arms 104, 106 in a closed position so that the leaflet clip 100 is retained on the leaflet. In some embodiments, the proximal end portion 120 of the tubular member 108 can define one or more notches 136 that allow the walls of the proximal end portion 120 to expand radially outward as they pass over the protrusions 134, thereby allowing the proximal end portion 120 to pass more easily over the protrusions 134. The walls of the proximal end portion 120 can then return to their original diameter distal to the protrusions 134.

[0021] In some embodiments, the leaflet clip 100 can include an active or passive leaflet engaging mechanism that can be disposed on the elongate member 102 to serve to engage and retain the leaflets of the heart valve in the respective first and second leaflet receiving regions 128, 130 when the clipping arms 104, 106 are moved from the open position to the closed position. For example, the leaflet clip 100 can include a passive leaflet engaging mechanism configured as a covering 138 disposed on the distal end portion 112 of the elongate member 102. The covering 138 can have a textured surface that can frictionally engage the leaflets when they are received in the leaflet receiving regions 128, 130 and retain the leaflets within the respective leaflet receiving regions 128, 130 when the clipping arms 104, 106 are moved from the open position to the closed position. In some embodiments, the covering 138 may include a woven or braided fabric, or may be a polymer tube or sleeve configured to be positioned over the distal end portion 112 of the elongate member 102. In some embodiments, the covering 138 may be made from any of a variety of natural or synthetic materials, such as polyethylene terephthalate (PET), foam, silicone, or suture material.

[0022] 4 and 5 show the leaflet clip 100 coupled to a representative embodiment of a delivery system 150 that can be used to deliver a leaflet clip such as the leaflet clip 100 to a desired heart valve. The delivery system 150 can include a main handle body 152 including an outer conduit or shaft 154 movable between proximal and distal positions, control buttons 156, 158, and two gripping portions 160. Referring to FIG. 5, the delivery system 150 further includes an actuator conduit or shaft 162 coaxially disposed within the outer conduit 154 and coupled to the tubular member 108, such that proximal or distal movement of the actuator conduit 162 in the direction indicated by the arrow 164 results in corresponding proximal or distal movement of the tubular member 108 relative to the elongate member 102 and clipping arms 104, 106.

[0023] As shown in FIGS. 6-8 , in some embodiments, the actuator conduit 162 can include a coupling device 166 that couples the actuator conduit 162 to the proximal end portion 120 of the tubular member 108. As shown in FIG. 7 , in some embodiments, the coupling device 166 can include a pair of angled tabs 163, 165 coupled to the actuator conduit 162 at their respective proximal ends, with the angled portions 163A, 165A of the tabs 163, 165 configured to extend radially beyond the diameter of the actuator conduit 162. In this manner, as shown in FIG. 8 , the tabs 163, 165 can act as springs such that when the outer conduit 154 is positioned around the distal end of the actuator conduit 162 (i.e., at a distal position), the inner surface of the outer conduit 154 contacts the angled portions 163A, 165A of the tabs 163, 165, causing them to deform radially inward relative to the actuator conduit 162. 9 and 10 , the tabs 163, 165 can extend into respective openings defined in the proximal end portion 120 of the tubular member 108. This allows the tabs 163, 165 of the actuator member 162 to be releasably engaged with the tubular member 108, such that proximal and / or distal movement of the actuator conduit 162 can result in proximal and / or distal movement of the tubular member 108, thereby causing movement of the clipping arms 104, 106 between the open and closed positions. In alternative embodiments, the actuator conduit 162 can be coupled to the tubular member 108 by any suitable coupling mechanism, including, for example, screws, clips, ball and detent systems, etc.

[0024] Proximal movement of the actuator conduit 162, and thereby the tubular member 108, can be limited by one or more of a variety of controllable motion-limiting mechanisms (e.g., cams, hard stops, pull tabs, etc.) that reduce the risk of locking the tubular member 108 in a distal position (i.e., preventing the proximal end portion 120 of the tubular member 108 from moving distally relative to the protrusion 134 of the elongate member 102) before successfully positioning the leaflet clip 100. The motion-limiting mechanism can establish a motion-limiting stop beyond which distal movement of the actuator conduit 162, outer conduit 154, and tubular member 108 as a combined unit is inhibited relative to the inner shaft 168. In the embodiment shown, such a motion-limiting mechanism can be controlled by the control button 156. For example, actuation of the control button 156 can allow the actuator conduit 162, outer conduit 154, and tubular member 108 to be moved past the limit stops such that the proximal end portion 120 of the tubular member 108 moves distally over the protrusion 134 of the elongate member 102, thereby locking the clipping arms 104, 106 in the closed position. Thus, after the leaflet clip 100 is clipped to the leaflets of a heart valve, actuation of the control button 156 can allow distal movement of the actuator conduit 162, outer conduit 154, and tubular member 108 past the limit stops, locking the clipping arms 104, 106 in the closed position.

[0025] Proximal movement of the outer conduit 154 may also be limited by one or more controllable motion-limiting mechanisms to reduce the risk of inadvertent detachment of the tubular member 108 from the actuator conduit 162 during positioning of the leaflet clip 100. In the embodiment shown, such motion-limiting mechanisms may be controlled by a control button 158. For example, actuation of the control button 158 may cause the outer conduit 154 to be moved proximally relative to the actuator conduit 162, thereby uncovering the tabs 163, 165, allowing them to resume their original, undeformed shape and disengage from the tubular member 108. This may allow the tubular member 108 to be removed from the delivery system 150. Thus, after final positioning of the leaflet clip 100 within the heart valve, actuation of the control button 158 may allow proximal movement of the outer conduit 154 and removal of the actuator conduit 162 from the tubular member 108.

[0026] 5 , the delivery system 150 can further include an inner member or shaft 168 coaxially disposed within the actuator conduit 162 and coupled at one end to the proximal end portion 110 of the elongate member 102 and at an opposite end to a handle member 170. In the embodiment shown, the inner member 168 can be threadably coupled to the proximal end portion 110 of the elongate member 102 such that rotation of the handle member 170 in the direction indicated by arrow 172 can decouple the inner member 168 from the elongate member 102. For example, the distal end portion of the inner member 168 can have external threads that threadably engage with internal threads formed on the interior surface of the proximal end portion 110 of the elongate member 102. In this manner, after final positioning of the leaflet clip 100 in the heart valve, the actuator member 162 can be disengaged from the tubular member 108 and the inner member 168 can be disengaged from the elongate member 102, allowing the delivery system 150 to be retracted, leaving the leaflet clip 100 in place.

[0027] In some embodiments, the outer conduit 154 may have a diameter of approximately 10 French, and the system 150 may be configured for use with a guidewire (e.g., threaded through the lumen 114 of the elongate member 102). In some embodiments, the respective conduits 154, 162 and inner member 168 of the delivery system 150 may be flexible or rigid, as desired. In some embodiments, the delivery system 150 may include steering elements to assist in positioning and orienting the leaflet clip 100 relative to the heart valve. Also, it should be understood that the respective conduits 154, 162 and inner member 168 of the delivery system 150 are shown at reduced lengths for illustrative purposes and may be of any suitable length.

[0028] In use, the delivery system 150 can be introduced into a patient's vasculature (e.g., via the femoral artery or other suitable access point) and advanced percutaneously into the patient's heart with the clipping arms 104, 106 in the closed (but unlocked) position using any of a variety of delivery techniques. In a transfemoral procedure, the delivery device can be inserted into the heart in a retrograde direction through the femoral artery and aorta (typically, but not exclusively, used to place clips on the leaflets of the aortic or mitral valves). Similarly, the delivery device can be inserted into the right side of the heart in an antegrade direction through the femoral vein and vena cava (typically, but not exclusively, used to place clips on the leaflets of the pulmonary or tricuspid valves). In a transventricular procedure, the delivery device is inserted into a bare spot on the lower anterior ventricular wall through a surgical incision made in the chest (typically, but not exclusively, used to place clips on the leaflets of the aortic or mitral valves). Similarly, the delivery device can be inserted through a surgical incision in the wall of the right ventricle to access the pulmonary or tricuspid valves. In a transatrial procedure, a delivery device is inserted through a surgical incision made in the wall of the left or right atrium to access the native valves on the left or right side of the heart, respectively. In a transaortic procedure, a delivery device is inserted through a surgical incision made in the ascending aorta and advanced toward the heart (typically, but not exclusively, used to place clips on the leaflets of the aortic or mitral valves). In a transseptal procedure, a delivery device can be advanced, such as via the femoral vein, through the septum separating the right and left ventricles into the right atrium (typically, but not exclusively, used to place clips on the leaflets of the aortic or mitral valves). Further details of delivery techniques for accessing the heart's native valves are disclosed in U.S. Patent Application Publication No. 2014 / 0067052.

[0029] Once the clipping arms 104, 106 are positioned adjacent to the desired heart valve, they are expanded by retracting the actuator conduit 162 and retracting the tubular member 108 relative to the clipping arms 104, 106. The leaflet clip 100 can then be positioned relative to the commissures of the valve and advanced and / or retracted distally as needed to position the leaflet clip 100 so that one leaflet of the commissure is received in the first leaflet receiving area 128 and the second leaflet of the commissure is received in the second leaflet receiving area 130. Once the leaflet clip 100 is properly positioned, the actuator conduit 162 can be advanced such that the tubular member 108 moves distally relative to the elongate member 102, urging the clipping arms 104, 106 toward the closed position.

[0030] The clip strength of the leaflet clip 100 can be tested by pulling the delivery system 150 proximally when the clipping arms 104, 106 are in the closed position. As used herein, the terms "clip retention force" and "clipping strength" refer to the proximal force that the leaflet clip can withstand without disengaging from the leaflets of the heart valve when the clipping arms are in the closed position. In some embodiments, the delivery system 150 can include a strain gauge or other device that measures the force applied to the leaflet clip 100. In some embodiments, the leaflet clip 100 can withstand a proximal force of 1 N to about 10 N while remaining clipped to the leaflet. For example, if the leaflet clip 100 is not properly positioned or does not exhibit adequate clipping strength when clipped to the leaflet, the tubular member 108 can be retracted by proximal movement of the actuator conduit 162, reopening the clipping arms 104, 106 and allowing the leaflet clip 100 to be repositioned. Once the leaflet clip 100 is properly positioned against the leaflet, the actuator member 162 can advance the tubular member 108 distal to the prongs 134, thereby locking the clipping arms 104, 106 in the closed position. The inner member 168 can then be disengaged from the elongate member 102, and the delivery system 150 can be retracted, leaving the leaflet clip 100 in place on the leaflet.

[0031] The leaflet clip 100 and any of the other leaflet clip embodiments described herein can be used to treat valvular insufficiency or remodel the annulus of a heart valve. For example, FIG. 11 shows three leaflet clips 202, 204, 206 similar to the leaflet clip 100 of FIG. 1 positioned within a native aortic valve 200. The native aortic valve 200 can include three leaflets 210, 212, 214 attached to a valve annulus 216. The leaflets 210 and 212 can form a first commissure 218, the leaflets 212 and 214 can form a second commissure 220, and the leaflets 210 and 214 can form a third commissure 222. Leaflet clips 202, 204, and 206 are shown positioned at the first commissure 218, the second commissure 220, and the third commissure 222, respectively, such that leaflet clip 202 engages leaflets 210 and 212, leaflet clip 204 engages leaflets 212 and 214, and leaflet clip 206 engages leaflets 214 and 210. Leaflet clips 202, 204, and 206 are also shown positioned near the wall of the valve annulus 216. In this manner, leaflet clips 202, 204, and 206 can improve coaptation of the leaflets 210, 212, and 214 at their respective commissures 218, 220, and 222, thereby reducing regurgitation through the valve 200 due to valvular regurgitation. Furthermore, although leaflet clips 202, 204, 206 are shown clipped to their respective leaflets adjacent to the annulus 216, leaflet clips 202, 204, 206 may be clipped to the leaflets at any suitable location along the leaflet, including the center of the commissures, as desired.

[0032] Leaflet clips 202, 204, 206 may also remodel annulus 216 of valve 200 to reduce dilation of annulus 216 and / or address abnormalities in the shape of annulus 216. For example, Figure 12 schematically illustrates remodeling of annulus 216 using leaflet clips such as clips 202, 204, 206 to reduce the diameter of the annulus from a dilated annular diameter D1 to a target or reduced annular diameter D2. As shown in Figures 13 and 14, such remodeling or diameter reduction can be achieved by reducing the circumference of annulus 216.

[0033] For example, Figure 13 shows the leaflet clip 202 with the clip arms in the open position. Hash marks 230, 232 are shown on the tissue to indicate the initial distance between the clipping arms and an initial reference for the circumference of the valve annulus. Dashed line 234 indicates the natural contour of the valve leaflet. Figure 14 shows the leaflet clip 202 with the clip arms in the closed position, such that the tissue of the valve annulus 216 adjacent to the clip 202 is gathered and clipped together by the leaflet clip. This allows the circumference, and therefore the diameter, of the valve annulus 216 to be reduced, as indicated by the movement of the hash marks 230, 232 relative to one another.

[0034] The effect of such diameter reduction is further illustrated in Figures 15, 16, and 17. Distances a, b, and c between three points 302, 304, and 306 shown schematically in Figure 15 and on the annulus of heart valve 300 in Figures 16 and 17 are reduced after adding three leaflet clips 308, 310, and 312 to the commissures of valve 300. In some embodiments, the diameter of the annulus can be reduced from an expanded diameter of about 29 mm to a target diameter of about 25 mm. In some embodiments, the diameter of the annulus can be reduced by about 10% to about 50%. In some embodiments, the diameter of the annulus can be reduced by about 14%.

[0035] As shown in FIGS. 18 and 19 , any of the leaflet clips disclosed herein can also be used in combination with one or more support rings. FIG. 19 shows three leaflet clips 402, 404, 406 clipped to the commissures of an aortic valve 400 as viewed from the aortic root. FIG. 18 illustrates the location of a support ring 408 on the ventricular side of the aortic valve 400, which can cooperate with the leaflet clips 402, 404, 406 to remodel and / or reduce the diameter of the aortic valve 400, as shown in FIG. 19 . An extension 410 on the central shaft of each of the leaflet clips in the left ventricle can extend through a respective opening in the ring 408, as shown. Alternatively, the ring 408 can be positioned around the extension 410. As shown in FIG. 19 , the leaflet clips 402, 404, 406 can also be used in conjunction with the support ring 408 or independently of any support device or structure to achieve commissure folding or plication.

[0036] As mentioned above, any of the leaflet clips disclosed herein can be used to treat valvular regurgitation or remodel the annulus of the mitral and / or tricuspid valve in addition to the aortic valve. Figures 20 and 21 illustrate the placement of a leaflet clip 502, similar to the leaflet clip 100 of Figure 1, on the leaflets 504, 506 of a mitral valve 500. As shown in Figures 20 and 21, the width of the clip arms 508 of the leaflet clip 502 is relatively narrow relative to the chordae tendineae of the mitral valve 500, thereby reducing interference of the clip arms 508 with the chordae tendineae both during and after implantation of the leaflet clip 502. If desired, one or more leaflet clips 502 can be positioned at or near the center of the leaflets 504, 506 or near the annulus during use.

[0037] 22 and 23 show placement of a leaflet clip 602, similar to the leaflet clip 100 of FIG. 1, on the leaflets 604, 606 of a tricuspid valve 600. As described above, the leaflet clip 602 can be used alone or in combination with one or more additional leaflet clips to reduce valve regurgitation and / or remodel the valve annulus.

[0038] Figures 24-32 illustrate various configurations of clipping arms that can be used in combination with any of the leaflet clips disclosed herein. Additionally, while the leaflet clips in Figures 24-26 are shown without a central elongate member, it should be understood that any of the leaflet clips described herein may or may not include an elongate member (e.g., member 102), as desired. Figure 24 illustrates a leaflet clip 700 in which clipping arms 702, 704 exhibit the bends shown at 702A and 704A and extend outward without exhibiting significant additional curvature (i.e., clipping arms 702, 704 are relatively straight).

[0039] FIG. 25 shows a leaflet clip 800 in which clipping points 802, 804 exhibit two bends, a first bend shown at 802A, 804A and a second bend shown at 802B, 804B, respectively, such that the clipping arms 802, 804 include respective distal portions 806, 808 angled away from the tubular member 810 at an angle α greater than about 45 degrees.

[0040] FIG. 26 shows a leaflet clip 900 in which clipping arms 902, 904 have curved distal end portions 906, 908.

[0041] FIG. 27 shows a leaflet clip 1000 similar to the leaflet clip 800 of FIG. 25, in which the clipping arms 1002, 1004 exhibit a first bend shown at 1002A, 1004A and a second bend shown at 1002B, 1004B, such that the distal portions 1006, 1008 of the clipping arms 1002, 1004 are angled away from the tubular member 1010 at an angle α of less than about 45 degrees.

[0042] FIG. 28 shows a leaflet clip 1100 in which clipping arms 1102, 1104 extend distally adjacent to the elongate member 1106 before bending away from the elongate member 1106, thereby reducing the area of ​​the respective leaflet receiving regions 1108, 1110.

[0043] 29 and 30 illustrate one embodiment of a clipping arm 1600 including one or more openings 1602 defined therein. The clipping arm 1600 can include openings 1602 located at a distal end portion of the clipping arm 1600, as shown in FIG. 29, or spaced along the length of the clipping arm 1600, as shown in FIG. 30. The clipping arm 1600 can include a fibrous covering or sleeve 1604 that can be disposed around the distal end portion of the clipping arm 1600, as shown in FIG. 29, or along the entire length of the clipping arm 1600, as shown in FIG. 30. The covering 1604 can be retained on the clipping arm 1600 by sutures 1606, which can be disposed around the covering 1604 and can be received or fastened through the plurality of openings 1602 to retain the covering 1604 on the clipping arm 1600. In this way, the covering 1604 can help to frictionally engage the tissue of the heart valve leaflets while reducing the risk of damage to the leaflets. In alternative embodiments, the clipping arm 1600 can include any suitable number of openings 1602 positioned at any suitable location along the length of the clipping arm, as desired, and can include a covering extending along any suitable percentage of the clipping arm 1600. The covering 1604 can be made from a suitable biocompatible fabric, such as PET.

[0044] 31 shows another embodiment of a clipping arm 1700 including a proximal end portion 1702 and a distal end portion 1704. In the embodiment shown, the clipping arm 1700 can be tapered such that the proximal end portion 1702 has a first diameter or width W1 and the distal end portion 1704 has a second diameter or width W2, where the first diameter W1 is greater than the second diameter W2. This can allow the distal end portion 1704 to have greater flexibility relative to the proximal end portion 1702 in the direction indicated by arrow 1706, which can reduce the risk of damage to the tissue of the native heart valve leaflets. The distal end portion 1704 can also include a protrusion 1708 having a relatively large diameter relative to the diameter W2 of the distal end portion 1704, which can reduce the risk of puncturing the native valve leaflets during or after implantation of the leaflet clip.

[0045] 32 shows another embodiment of a clipping arm 1800 including an inner member 1802 and an overmolded cover 1804 (i.e., "insert molding"). The cover 1804 can be made from any biocompatible polymer (e.g., silicone, ePTFE, etc.) and can include texture, dimples, or other surface features that help engage and retain the tissue of the native valve leaflets. The inner member 1802 can be made from a metal or polymeric material, as desired.

[0046] FIG. 33 illustrates another embodiment of a leaflet clip 1200 similar to the leaflet clip 100 of FIG. 1 . The leaflet clip 1200 can include an elongated member 1202 and two clipping arms 1204, 1206. The leaflet clip 1200 is shown without a tubular member (sheath) for illustrative purposes. The leaflet clip 1200 can include a passive leaflet engagement mechanism configured as a tube or sleeve 1208 and disposed on a distal end portion 1210 of the elongated member 1202. The sleeve 1208 can be made from, for example, polyester and can be configured to frictionally engage and retain the leaflets of the heart valve between the respective clipping arms 1204, 1206 and the elongated member 1202 when the clipping arms are moved from an open position to a closed position.

[0047] 34 schematically illustrates the relative positions of the native leaflets 1302, 1304 of a heart valve 1306 with respect to the clipping arms 1308, 1310 of the leaflet clip 1300 before and after the clipping arms 1308, 1310 are moved from an open position to a closed position. In a manner similar to the leaflet clip embodiments described above, the clipping arms 1308, 1310 can be moved from an open position to a closed position by distal movement of the tubular member 1316 from a first position (shown in solid lines) to a second position (shown in phantom). When the leaflets 1302, 1304 are received in their respective leaflet receiving areas 1312, 1314, the ends of the clipping arms 1308, 1310 can contact the leaflets 1302, 1304 at respective points A along the respective leaflets 1302, 1304. In some embodiments, when the clipping arms 1308, 1310 are moved from the open position to the closed position, the leaflets 1302, 1304 can slip such that when the clipping arms 1308, 1310 are in the closed position, they contact the leaflets 1302, 1304 at their respective points B. Depending on the desired gripping strength, in some circumstances it may be advantageous to retain a greater proportion of the leaflets 1302, 1304 within the leaflet receiving areas 1312, 1314 when the clipping arms are moved from the open position to the closed position.

[0048] Toward such end, Figures 35 and 36 illustrate another embodiment of a leaflet clip 1400 including an elongated member 1402 and two clipping arms 1404, 1406. The leaflet clip 1400 can include an active leaflet engagement mechanism 1408 configured as a woven or knitted covering 1410 disposed on the elongated member 1402 between a fixed proximal retention member 1412 and a distal retention member 1414 that is movable between distal and proximal positions. When the leaflet clip 1400 is positioned so that the native leaflets 1416, 1418 are received within the respective leaflet receiving areas 1420, 1422, the distal retention member 1414 can be moved proximally in the direction indicated by arrow 1424 in Figure 36 (e.g., by actuation of a member disposed within the elongated member 1402). Movement of the distal retention member 1414 toward the proximal retention member 1412 bunches the shroud 1410, causing it to expand or distend radially away from the elongate member and engage the leaflets 1416, 1418 between the shroud 1410 and the respective clipping arms 1404, 1406. When the distal retention member 1414 is in the proximal position, the tubular member 1426 can be advanced distally to move the clipping arms 1404, 1406 from the open position to the closed position. In this manner, by retaining the leaflets 1416, 1418 at their respective leaflet receiving areas 1420, 1422 while the clipping arms 1404, 1406 are moved to the closed position, a greater proportion of the leaflets can be retained by the leaflet clip 1400 against the elongate member 1402, resulting in a stronger grip on the leaflets and improved performance of the leaflet clip 1400. Furthermore, the leaflet engagement mechanism 1408 can help reduce slippage of the leaflets 1416, 1418 past the clipping arms 1404, 1406 when they are moved to the closed position, ensuring a greater proportion of the leaflets 1416, 1418 are retained in the leaflet receiving areas 1420, 1422 and increasing retention of the leaflet clip 1400 against the leaflets 1416, 1418.

[0049] 37 and 38 show another embodiment of a leaflet clip 1500 including an elongate member 1502, two clipping arms 1504, 1506, and a sheath 1526. The leaflet clip 1500 can include an active leaflet engagement mechanism 1508 configured as a sleeve 1510 including a plurality of protrusions 1512 axially spaced apart from one another along the sleeve 1510. The sleeve 1510 can be movable between distal and proximal positions relative to the clipping arms 1504, 1506, as indicated by arrow 1514 ( FIG. 37 ). As shown in FIG. 38 , the protrusions 1512 can have respective edge portions 1516 configured to engage or grip native leaflets 1518, 1520 disposed in respective leaflet receiving regions 1522, 1524 when the sleeve 1510 is moved proximally. Thus, when the clipping arms 1504, 1506 are moved to the closed position (e.g., by advancing the sheath 1526 over the clipping arms), the edge portions 1516 of the protrusions 1512 can engage and retain the leaflets 1518, 1520 within the leaflet receiving areas 1522, 1524, thereby preventing the leaflets from slipping out of the leaflet receiving areas. As a result, a greater proportion of the leaflets 1518, 1520 can be retained by the clipping arms 1504, 1506 against the elongate member 1502, resulting in a stronger grip on the leaflets and improved performance of the leaflet clip 1500.

[0050] In the illustrated embodiment, the sleeve 1510 includes three protrusions 1512. However, it should be understood that the sleeve 1510 can include any suitable number of protrusions having any suitable size and spacing relative to one another. In some embodiments, the sleeve 1510 can be disposed over the elongate member 1502, which can be movable proximally and / or distally. In alternative embodiments, the sleeve 1510 can be disposed over a shaft or conduit that is coaxially disposed within (or over) the elongate member 1502 and independently actuated from outside the body. In some embodiments, the sleeve 1510 can be made from a natural or synthetic material, such as polyester. In some embodiments, the spaces between the protrusions 1512 can function as tissue collection areas (see discussion of FIGS. 42-46 ), helping to increase the clip strength of the leaflet clip 1500.

[0051] 39 and 40 schematically illustrate alternative coupling orientations of a leaflet clip to a delivery system. In FIG. 39, the leaflet clip 1900 is shown coupled to a delivery system 1902 with clipping arms 1904, 1906 extending distally relative to the delivery system 1902. FIG. 40 illustrates the leaflet clip 2000 coupled to a delivery system 2002 with clipping arms 2004, 2006 extending proximally relative to the delivery system 2002. It should be understood that these coupling orientations may be applied to any of the leaflet clips described herein and may facilitate the various delivery techniques discussed above.

[0052] Figure 41 shows another embodiment of a leaflet clip 2100 coupled to a delivery system 2102 such that the clipping arms 2104, 2106 extend proximally relative to the delivery system 2102, similar to the embodiment of Figure 40. The leaflet clip 2100 can include a tubular member 2108 coaxially disposed about an elongate member 2110 and movable between a distal position and a proximal position such that the clipping arms 2104, 2106 are urged by the tubular member 2108 from an open position to a closed position, respectively. The tubular member 2108 can be coupled to an actuator member 2112 via a coupling device 2114, shown as a threaded engagement between the distal end of the tubular member 2108 and the actuator member 2112. The actuator member 2112 may extend coaxially through the elongate member 2110 and may be movable relative to the elongate member 2110 such that proximal or distal movement of the actuator member 2112 results in corresponding proximal or distal movement of the tubular member 2108 in the direction indicated by arrow 2113.

[0053] The elongate member 2110 can be coupled to the inner conduit 2116 by tabs 2118, 2120 that are received in respective openings 2122, 2124 in the elongate member 2110. The tabs 2118, 2120 can be retained in the openings 2122, 2124 by an adjacent outer conduit 2126 that is coaxially disposed about the inner conduit 2116 and configured such that an inner surface of the outer conduit 2126 contacts the tabs 2118, 2120, compressing or deforming them into the openings 2122, 2124 of the elongate member 2110. In this manner, the leaflet clip 2100 can remain coupled to the delivery system 2102 while allowing proximal and distal movement of the actuator member 2112 and tubular member 2108 to facilitate positioning and / or repositioning of the clipping arms 2104, 2106.

[0054] In the embodiment shown, the elongate member 2110 can include tabs or extensions 2128, 2130 near the distal end of the elongate member 2110 that can be received in corresponding openings 2132, 2134 defined in the tubular member 2108. In this manner, after final positioning of the leaflet clip, the actuator member 2112 can be moved proximally relative to the elongate member 2110, causing the tubular member 2108 to deform the clipping arms 2104, 2106 to the closed position and the tabs 2128, 2130 to be received in the openings 2132, 2134 of the tubular member 2108, thereby locking the tubular member 2108 in the proximal position and locking the clipping arms 2104, 2106 in the closed position. The outer conduit 2126 can then be moved proximally in the direction of arrow 2136, allowing the tabs 2118, 2120 of the inner conduit 2116 to disengage from the elongate member 2110. The actuator member 2112 can then be rotated, for example, in the direction indicated by arrow 2138, causing the threaded coupling 2114 between the actuator member 2112 and the tubular member 2108 to disengage. The delivery system 2102 can then be withdrawn, leaving the leaflet clip 2100 in place.

[0055] 42 and 43 illustrate another embodiment of a leaflet clip 2200 comprising an elongate member 2202, a first clipping arm 2204 and a second clipping arm 2206, and a tubular member 2208 disposed coaxially relative to the elongate member 2202. The elongate member 2202 can have a proximal end portion 2210 and a distal end portion 2212, the distal end portion 2212 having a diameter D1 that is larger than the diameter D2 of the proximal end portion 2210. In this manner, the clipping arms 2204, 2206 can define respective tissue collection areas 2214, 2215 between the respective clipping arms 2204, 2206 and the elongate member 2202 when the clipping arms are in the closed position, as shown in FIG. 43 . In the embodiment shown, the tissue collection areas 2214, 2215 can have respective width dimensions X1 and X2 and height dimensions H1 and H2. In some embodiments, the width dimensions X1 and X2 can vary along the height of each tissue collection area due, for example, to the angle between each clipping arm 2204, 2206 and the elongate member 2202 and / or the deflection of the clipping arms 2204, 2206 when they are in the closed position.

[0056] The clipping arms 2204, 2206 may also define respective tissue compression regions 2220, 2222 having respective width dimensions W1 and W2 between the clipping arms 2204, 2206 and the elongate member 2202. In some embodiments, as described above, the dimensions W1 and W2 may vary along the length of the respective tissue compression regions 2220, 2222 due to the angle between the respective clipping arms 2204, 2206 and the elongate member 2202 and / or the flexure of the clipping arms 2204, 2206.

[0057] The tissue collection regions 2214, 2215 can be located adjacent the proximal end portion of the elongate member 2202 and can be configured such that end portions of the heart valve's native leaflets extend into the tissue collection regions 2214, 2215. In the tissue collection regions 2214, 2215, tissue at the free end portions of the leaflets can be gathered or bunched together, while simultaneously engaging or pinching an underlying portion of the leaflets between the clipping arms 2204, 2206 and the elongate member 2202 in the tissue compression regions 2220, 2222. This can result in a difference in leaflet tissue thickness in the tissue collection regions 2214, 2215, where the tissue is relatively unconstrained and / or uncompressed, and the leaflet tissue thickness disposed in the tissue compression regions 2220, 2222. This thickness difference can significantly increase the clip strength of the leaflet clip 2200, thereby increasing the ability of the leaflet clip to remain clipped to the leaflets of a functioning heart valve.

[0058] For example, Figures 44 and 45 schematically illustrate the mechanics of the tissue collection and compression regions. In Figure 44, a free end portion 2304 of a valve leaflet 2302 is pinched between a clipping arm 2306 and an elongated member 2308 of a leaflet clip 2300. When in an unconstrained state, the leaflet 2302 can have a thickness T, and the leaflet clip 2300 can be configured such that the clipping arms 2306 and the elongated member 2308 define a tissue compression region 2310 (corresponding to the tissue compression regions 2220, 2222 of Figures 42 and 43) having a dimension D when the clipping arms 2306 are in the closed position. In a typical example, the distance D between the elongated member 2308 and the clipping arms 2306 can be configured to compress the tissue of the leaflet 2302 such that the leaflet tissue thickness T is reduced by about 50% relative to the unconstrained tissue thickness. Thus, for a leaflet having a thickness T of approximately 1 mm, the thickness compression region 2310 can be configured to compress tissue disposed therein such that its thickness T is reduced to approximately 0.5 mm. This rate of thickness reduction generally results in greater retention of the leaflet tissue between the clipping arms 2306 and the elongate member 2308 while minimizing the risk of damage to the leaflet 2302.

[0059] As mentioned above, FIG. 44 shows the free end portion 2304 of the leaflet 2302 positioned in the tissue collection region 2310. In a typical example, such a configuration can withstand the application of a proximal force of approximately 1 N. However, by configuring the leaflet clip 2300 so that the free end portion 2304 of the leaflet 2302 is relatively unconstrained, such as when positioned within the tissue collection region, while the central portion 2312 of the leaflet 2302 is compressed in the tissue compression region 2310, the clipping strength of the leaflet clip can be significantly increased. FIG. 45 schematically illustrates such a configuration, in which the central portion 2312 of the leaflet 2302 is pinched within the leaflet compression region 2310 so that its thickness is reduced to approximately 0.5T, while the free end portion 2304 of the leaflet 2302 is positioned within the tissue collection region 2314 and allowed to maintain its natural thickness T. In some embodiments, this configuration can allow the leaflet clip 2300 to withstand the application of a proximal force of approximately 4 N, which can significantly improve the clipping strength of the leaflet clip. The use of shapes such as the tissue collection regions 2214, 2215 can also promote long-term stability of the leaflet clip 2200 after implantation by encouraging tissue in-growth within the tissue collection regions 2214, 2215 and around the clip 2200.

[0060] 46 illustrates the leaflet clip 2200 with the clipping arms 2204, 2206 in a closed position with the leaflets 2216, 2218 captured within the tissue compression regions 2220, 2222. The tissue compression regions 2220, 2222 can be configured, as described above, to compress the portions of the leaflets 2216, 2218 disposed within the regions 2220, 2222 such that their respective thicknesses T are reduced to approximately 0.5T. Meanwhile, the tissue collection regions 2214, 2215 can be configured to allow the free end portions 2224, 2226 of the leaflets 2216, 2218 to maintain their natural thickness T, thereby significantly increasing the clip strength of the leaflet clip 2200.

[0061] In some embodiments, the width dimensions X1, X2 and height dimensions H1, H2 of the tissue collection regions 2214, 2215 and / or the width dimensions W1, W2 of the tissue compression regions 2220, 2222 can be sized according to the thickness T of the valve leaflets 2218, 2220. For example, in some embodiments, the width dimensions X1, X2 of the tissue collection regions 2214, 2215 can be about 1T to about 2T. In some embodiments, the width dimensions X1, X2 of the tissue collection regions 2214, 2215 can be about 1T. In some embodiments, the height dimensions H1, H2 of the tissue collection regions 2214, 2215 can be about 1T to about 2T. In some embodiments, as discussed above, the width dimensions W1, W2 of the tissue compression regions 2220, 2222 can be about 0.5T.

[0062] 47 shows another embodiment of a leaflet clip 2400 including a tubular central member 2402 having a proximal end portion 2404 and a distal end portion 2406. The distal end portion 2406 can include a first clipping arm 2408 and a second clipping arm 2410 that are movable between open and closed positions. The clipping arms 2408, 2410 can define a leaflet receiving area 2411 therebetween that can receive leaflets 2416, 2418 of a heart valve. The leaflet clip 2400 can also include a tubular outer member 2412 that is coaxially disposed about the central member 2402 and is movable between proximal and distal positions relative to the central member 2402. The outer member 2412 can be configured such that when moved from the proximal position to the distal position, the inner surface of the outer member 2412 contacts the clipping arms 2408, 2410, forcing or deforming them from the open position to the closed position.

[0063] The leaflet clip 2400 can also include a helical member 2414, shown in the shape of a corkscrew. The helical member 2414 can be disposed within a lumen of the central member 2402 and can be movable between a proximal position and a distal position relative to the central member 2402. In this manner, when the leaflets 2416, 2418 are received in the leaflet receiving areas 2411, the clipping arms 2408, 2410 are in a closed position and the helical member 2414 can be advanced distally through the lumen of the central member 2402 to engage the leaflets 2416, 2418. This can result in crimping of the leaflets 2416, 2418, which can improve the clipping strength of the leaflet clip 2400. In some embodiments, the helical member 2414 can pierce the leaflets 2416, 2418 or can engage the leaflets 2416, 2418 without piercing them, as desired. In some embodiments, the helical member 2414 can also include a detachable coupling mechanism 2420 for coupling the leaflet clip 2400 to a delivery device.

[0064] 48 illustrates another embodiment of a leaflet clip 2500 including a central member 2502 with two clipping arms 2504, 2506 extending distally therefrom. The clipping arms 2504, 2506 can be movable between open and closed positions and can define a leaflet receiving area 2508 that can receive the leaflets 2510, 2512. The leaflet clip 2500 can further include a helical member 2514, which can be movable between a proximal position and a distal position. In some embodiments, the helical member 2514 can include, for example, a helically wound metal wire. When in the distal position, the helical member 2514 can be disposed around the clipping arms 2510, 2512 and configured to restrict radial movement of the clipping arms 2504, 2506 relative to one another. In this manner, the helical member 2514 can hold the leaflets 2510, 2512 between the clipping arms 2504, 2506, thereby holding the leaflet clip 2500 on the heart valve.

[0065] 49 and 50 show another embodiment of a delivery device 2600 that can be used in combination with any of the leaflet clips described herein. The delivery device can include a handle body 2602 including a proximal handle portion 2604 and a distal handle portion 2606. The delivery device can further include an outer conduit 2608 coupled to the distal handle portion 2606, and an intermediate conduit or clip release conduit 2610 coaxially disposed within the outer conduit 2608 and coupled to the proximal handle portion 2604. The clip release conduit 2610 can be movable proximally and distally relative to the outer conduit 2608 with proximal and distal movement of the proximal handle portion 2604. The delivery device can further include a clip retainer conduit 2612 coaxially disposed within the clip release conduit 2610 and coupled to the distal handle portion 2606. Similar to the embodiment of Figures 1-10 above, in the embodiment shown, the clip retention conduit 2612 is covered by the clip release conduit 2610 and can include tab portions 2614, 2616 (Figure 50) that engage openings in the tubular member 2618 of the leaflet clip 2620 when deformed inward.

[0066] The delivery device can also include an inner shaft or conduit 2622 ( FIG. 40 ) coaxially disposed within the clip retention conduit 2612. The inner shaft 2622 can be coupled to a proximal end portion of the leaflet clip's central elongate member 2624 ( FIG. 50 ), such that proximal and distal movement of the inner shaft 2622 results in corresponding proximal and distal movement of the elongate member 2624 relative to the tubular member 2618. By moving the leaflet clip's central elongate member 2624 relative to the tubular member 2618, the clipping arms 2626, 2628 can be retracted proximally into the tubular member 2618, deforming the clip arms to move them to a closed position, or pushed distally from the tubular member, returning the clip arms to an undeformed, open state. Alternatively, the inner shaft 2622 can be coupled to the tubular member 2618 such that longitudinal movement of the inner shaft causes corresponding longitudinal movement of the tubular member that opens and closes the clip arms.

[0067] In the embodiment shown, the inner shaft 2622 can also include a handle portion 2630 for effecting proximal and distal movement of the inner shaft. The inner shaft 2622 can also define a lumen in communication with the lumen of the elongate member 2624 for receiving a guidewire. The handle portion 2602 can also include a locking mechanism to prevent inadvertent separation of the proximal and distal handle portions (e.g., during shipping).

[0068] In the embodiment shown, the clip release conduit 2610 may include a pin or protrusion 2632 movable with the clip release conduit in a track or guide 2634 defined in the outer conduit 2608. In the embodiment shown, the guide 2634 may include a circumferentially extending distal portion 2636, a longitudinally extending intermediate portion 2638, and a longitudinally extending proximal portion 2640 circumferentially offset from the intermediate portion, although other configurations are possible.

[0069] When the device is inserted into the body and advanced toward the heart, the proximal handle portion 2604 and the distal handle portion 2606 can be adjacent one another, and the clip release conduit 2610 can be positioned distally such that the protrusion 2632 is within the distal portion 2636 of the guide 2634, and the leaflet clip is disposed within the lumen of the clip release conduit. When the distal end of the device reaches the desired implantation site, the proximal handle portion 2604 can be rotated, causing a corresponding rotation of the clip release conduit 2610. This can move the protrusion 2632 of the clip release conduit into the intermediate portion 2638 of the guide 2634. The proximal handle portion 2604 can then be pulled or retracted proximally away from the distal handle portion 2606, causing corresponding proximal movement of the clip release conduit 2610 and the protrusion 2632 in the intermediate portion 2638 of the guide. The clip release conduit 2610 can be retracted a sufficient distance to expose the clip arms of the leaflet clip 2620, but not so far that the tabs 2614, 2616 of the clip retention conduit are exposed and allow the leaflet clip to be opened and removed from the delivery device.

[0070] The leaflet clip 2620 can then be clipped onto and / or detached from the native leaflets of the target heart valve by proximal and distal movement of the inner shaft 2622. Once proper placement of the leaflet clip on the native leaflet is achieved, the clip arms 2626, 2628 can be locked into a closed position. The proximal handle portion 2604 can then be rotated such that the protrusion 2632 moves into the distal portion 2640 of the guide 2634. This allows the handle portion 2604 to be moved further proximally, causing the clip release conduit 2610 to uncover the tabs 2614, 2616 of the clip retention conduit 2612 and remove the leaflet clip from the delivery device.

[0071] The delivery devices shown in Figures 49 and 50 can be adapted for use with a transapical delivery procedure, however, the devices of Figures 49 and 50 can be adapted for use with any suitable delivery procedure, including transfemoral, transatrial, transseptal, etc.

[0072] In view of the many possible embodiments to which the principles of the disclosed technology can be applied, it should be recognized that the illustrated embodiments are merely preferred examples and should not be construed as limiting the scope of the present disclosure, which is rather defined by the claims that follow.

[0073] Furthermore, the present invention preferably includes the following examples. [Section 1] A leaflet clip comprising: an elongate member including a proximal end portion and a distal end portion; a first clipping arm and a second clipping arm movable between an open position and a closed position, the first clipping arm and the second clipping arm including respective proximal end portions coupled to the proximal end portion of the elongate member and respective distal end portions extending distally and radially outwardly relative to the elongate member; a tubular member coaxially disposed around the elongated member; wherein axial movement of the tubular member relative to the elongated member or axial movement of the elongated member relative to the tubular member causes corresponding movement of the first and second clipping arms between the open and closed positions. [Section 2] Item 1, a valve leaflet clip according to item 1, wherein the proximal end portion of the tubular member is configured for attachment to a delivery device. [Section 3] Item 3. The leaflet clip according to item 1 or 2, further comprising a leaflet engagement mechanism disposed at the distal end portion of the elongate member. [Section 4] Item 4. The leaflet clip described in item 3, wherein the leaflet engagement mechanism is a polymer or fabric covering configured to engage the native leaflets of the heart valve when the first and second clipping arms are moved from the open position to the closed position. [Section 5] Item 5. The valve leaflet clip of item 4, wherein the cover is retained on the elongated member by a first retaining member fixedly positioned on the elongated member proximal to a second retaining member, and the second retaining member is movable relative to the first retaining member such that proximal movement of the second retaining member relative to the first retaining member causes radial expansion of the cover. [Section 6] Item 5. The leaflet clip according to item 4, wherein the covering is made of natural or synthetic fiber material and is woven, knitted, or any combination thereof. [Section 7] Item 4. The leaflet clip of item 3, wherein the leaflet engagement mechanism includes one or more protrusions spaced apart from one another and disposed on the distal end portion of the elongate member. [Section 8] A leaflet clip described in any one of items 1 to 7, wherein the proximal end portion of the elongated member comprises a retention mechanism configured to hold the tubular member in a distally extended position relative to the elongated member, and in the distally extended position, the tubular member extends over the first and second clipping arms and holds the first and second clipping arms in the closed position. [Section 9] Item 9. The valve leaflet clip of any one of items 1 to 8, wherein the first and second clipping arms are integrally formed with a collar disposed on the proximal end portion of the elongate member. [Section 10] Item 10. A valve leaflet clip according to any one of items 1 to 9, wherein the tubular member includes a first extension portion and a second extension portion configured to contact the first clipping arm and the second clipping arm, respectively, when the tubular member moves axially. [Section 11] Item 11. The leaflet clip of any one of items 1 to 10, wherein the proximal end portion of the elongate member is configured to be attached to a delivery device. [Section 12] Item 12. A valve leaflet clip according to any one of items 1 to 11, wherein the elongated member defines a lumen configured to receive a guidewire. [Section 13] 13. The valve leaflet clip of any one of paragraphs 1 to 12, wherein the valve leaflet clip is configured for use with a mitral valve, an aortic valve, a tricuspid valve, or any combination thereof. [Section 14] Item 14. The leaflet clip of any one of items 1 to 13, further comprising a tissue compression region and a tissue collection region. [Explanation of symbols]

[0074] 100, 202, 204, 206, 308, 310, 312, 402, 404, 406, 502, 602, 700, 800, 900, 1000, 1100, 1200, 1300, 1400, 1500, 1900, 2000, 2100, 2200, 2300, 2400, 2500, 2620 Leaflet Clips 102, 1006, 1106, 1202, 1402, 1502, 2110, 2202, 2624 Elongated member, shaft 104, 2204, 2408 First clipping arm 106, 2206, 2410 Second Clipping Arm 108, 1010, 1316, 2108, 2208, 2618 Tubular members 110, 120, 1702, 2210, 2404 Proximal end portion 112, 906, 908, 1704, 2212, 2406 distal end section 114 Lumen 116 Annular Collar 118, 163, 165, 2118, 2120, 2614, 2616 Tabs 122 First Extension 124 Second Extension 126 slots 128, 130, 1108, 1110, 1312, 1314, 1420, 1422, 1522, 1524, 2411 Leaflet receiving area 132 Locking mechanism, retention mechanism 134, 1512 protrusion 136 Notch 138, 1410 Cover 150, 1902, 2002, 2102 Delivery Systems 152 Main handle body 154, 2608 Outer conduit, shaft 156, 158 Control buttons 160 Gripping part 162 Actuator members, actuator conduits, shafts 260 Actuator conduit 163A, 165A angled section 165, 1602, 2122, 2124, 2132, 2134 openings 168, 1802 Inner shaft, inner member 200, 400 aortic valve 210, 212, 214, 504, 506, 604, 606, 1302, 1304, 1416, 1418, 1518, 1520, 2302, 2416, 2418, 2510, 2512 leaflets 216 Valvular annulus 218 First commissure 220 Second commissure 222 Third commissure 300, 1306 Heart valves 408 Support Ring 410 Cylinder 500 Mitral valve 508, 702, 704, 802, 804, 902, 904, 1002, 1004, 1102, 1104, 1204, 1206, 1308, 1310, 1404, 1406, 1504, 1506, 1600, 1700, 1800, 1904, 1906, 2004, 2006, 2104, 2106, 2204, 2206, 2306, 2408, 2410, 2504, 2506, 2510, 2512, 2626, 2628 Clipping Arm 600 Tricuspid valve 802, 804 clipping points 806, 808, 1006, 1008, 2636 Distal portion 1604, 1804 Cover 1606 Sutures 1208, 1510 Tubes, sleeves, tubular members 1408 Active leaflet engagement mechanism 1412 Proximal retention member 1414 Distal retention member 1516 Edge part 1526 Sheath 2112 Actuator member 2114 Coupling Device 2128, 2130 Tabs, Extensions 2214, 2215, 2314 Tissue collection area 2220, 2222 Tissue compression area 2224, 2226, 2304 Free end part 2310 Leaflet compression area 2312 Central part 2402 Central member 2412 Outer member 2414, 2514 Spiral member 2602, 2630 Handle body, handle part 2604 Proximal handle portion 2606 Distal handle portion 2610 Intermediate conduit, clip release conduit 2612 Clip-retaining conduit 2614, 2616 tab part 2622 Inner shaft, conduit 2632 Protrusion 2634 Truck, Guide 2638 Middle part 2640 Proximal part

Claims

1. 1. A clip for attachment to two leaflets of a heart valve, comprising: an elongate member configured to be positioned between two leaflets of the heart valve; a first arm and a second arm coupled to the first portion of the elongate member and extending toward the second portion of the elongate member, the first arm extends radially away from the elongate member as the first arm extends from the first portion toward the second portion to form a first leaflet receiving area when the first arm is in an open position; the second arm extends radially away from the elongate member as the second arm extends from the first portion toward the second portion to form a second leaflet receiving area when the second arm is in the open position. a first arm and a second arm; a passive leaflet engagement mechanism comprising a cover disposed on the elongated member; It is equipped with The cover includes a textured surface.

2. 2. The clip of claim 1, wherein the passive leaflet engagement mechanism is configured to help engage and retain the leaflets of the heart valve at the corresponding first and second leaflet receiving areas, respectively, when the first and second clipping arms are moved from an open position to a closed position.

3. The clip of claim 1 , wherein the cover is disposed on the second portion of the elongated member.

4. 2. The clip of claim 1, wherein the textured surface is configured to frictionally engage the leaflets of the heart valve at the corresponding first and second leaflet receiving areas when the first and second clip arms are moved from the open position to the closed position.

5. The clip of claim 1 , wherein the covering is made from polyethylene terephthalate, foam, or suture material.

6. The clip of claim 1 , wherein the first arm and the second arm are hingedly connected.

7. The clip of claim 1 , wherein the first arm and the second arm are made from titanium, nickel titanium, plastic, or stainless steel.

8. The clip of claim 1 , wherein the width of the second portion is greater than the width of the first portion.

9. The clip of claim 1 , further comprising a cover disposed on the first clipping arm and the second clipping arm.

10. 10. The clip of claim 9, wherein the first clipping arm and the second clipping arm include a plurality of openings, and the covering is retained on the first clipping arm and the second clipping arm by a suture received through the plurality of openings.

11. a delivery system; A valve repair device according to any one of claims 1 to 10 coupled to the delivery system; An assembly comprising:

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