HK40086869A - Percutaneous clip for repairing a heart valve - Google Patents

Description

Percutaneous clamps for repairing heart valves

This application is a divisional application of Chinese patent application 202010262883.9 entitled "Percutaneous clamp for repairing heart valves", filed on December 4, 2015, which in turn is a divisional application of Chinese patent application 201580074739X (PCT/US2015/064096) entitled "Percutaneous clamp for repairing heart valves", filed on December 4, 2015.

Technical Field

This disclosure relates to apparatus and methods for treating valvular heart failure.

Background Technology

Heart valve insufficiency typically involves the regurgitation of blood through heart valves that cannot close completely or properly, leading to impaired cardiovascular function. Valvular insufficiency can affect, for example, the mitral, aortic, or tricuspid valves, and can be associated with calcified or prolapsed leaflets and/or bulging or deformation of the valvular annulus. One approach to treating heart valve insufficiency is to use one or more leaflet clips to improve the apposition of the natural leaflets. However, conventional leaflet clips can be difficult to implant, may interfere with or damage associated valvular structures such as chordae tendineae, and are often limited to use with a single type of heart valve. Therefore, improvements in devices and methods for treating heart valve insufficiency are desired.

Summary of the Invention

Certain embodiments of this disclosure relate to leaflet clips and apparatus and methods for introducing leaflet clips into heart valves. In one representative embodiment, the leaflet clip includes: an elongated member including a proximal portion and a distal portion; and a first clamping arm and a second clamping arm movable between an open position and a closed position. The clamping arms include a corresponding proximal portion coupled to the proximal portion of the elongated member, and a corresponding distal portion extending distally and radially outward relative to the elongated member. The leaflet clip further includes a tubular member coaxially disposed around the elongated member. 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 clamping arms between the open and closed positions.

In another representative embodiment, a method includes positioning a leaflet clamp adjacent to a commissure of a heart valve, such that a first clamping arm is adjacent to a first leaflet of the heart valve, and a second clamping arm is adjacent to a second leaflet of the heart valve, with an elongated member positioned between the leaflets. The method further includes moving a sheath coaxially disposed on the elongated member distally relative to the elongated member, or moving the elongated member proximally relative to the sheath, such that the sheath moves the clamping arms from an open position to a closed position, thereby capturing the first leaflet between the first clamping arm and the elongated member, and capturing the second leaflet between the second clamping arm and the elongated member.

The foregoing and other objects, features and advantages of this disclosure will become more apparent from the following detailed description with reference to the accompanying drawings.

Attached Figure Description

Figure 1 illustrates a perspective view of a representative embodiment of the leaf clamp.

Figure 2 shows a partial exploded view of the leaf clamp in Figure 1, with the clamping arm in the open position.

Figure 3 shows a perspective view of the leaf clamp of Figure 1, with the clamping arm in the closed position.

Figure 4 is a perspective view of a representative embodiment of a delivery system that can be used in conjunction with the leaf clamp of Figure 1.

Figure 5 is an exploded view of the delivery system in Figure 4.

Figures 6 and 7 illustrate embodiments of the actuator conduit.

Figure 8 illustrates an embodiment of an outer conduit coaxially arranged around the actuator conduit of Figure 6.

Figures 9 and 10 illustrate an embodiment of a tubular member positioned distally around an elongated member.

Figure 11 is a cross-sectional plan view of a heart valve with three leaflet clips for implantation.

Figure 12 is a schematic diagram illustrating a heart valve with a reduced annular diameter.

Figure 13 is a side view of a leaflet clamp installed in a heart valve, with the clamping arm in the open position.

Figure 14 is a side view of the leaf clamp in Figure 8, with the clamping arm in the closed position.

Figure 15 is a schematic plan view of the heart valve, illustrating the distance between reference points on the wall of the valve annulus.

Figure 16 is a cross-sectional plan view of the heart valve, illustrating the distance between reference points on the wall of the valve annulus before the leaflet clip is implanted.

Figure 17 is a cross-sectional plan view of the heart valve in Figure 11, illustrating the reduction in the diameter of the valve annulus after implantation of the leaflet clip.

Figure 18 is a ventricular side cross-sectional view of the aortic valve, illustrating the implantation of support rings on the three leaflet clips.

Figure 19 is a cross-sectional view of the valve on the aortic side of Figure 13, illustrating the reduced diameter of the valve annulus with leaflet clamps and support rings.

Figures 20 and 21 illustrate the implantation of a leaflet clip into the mitral valve.

Figures 22 and 23 illustrate the implantation of a leaflet clip into the tricuspid valve.

Figure 24-32 illustrates various representative configurations of the clamping arms of the leaf clamp.

Figure 33 illustrates another embodiment of a leaf clamp including a passive leaflet engagement mechanism.

Figure 34 illustrates the movement of the leaflet of the heart valve relative to the clamping arm of the leaflet clamp as the clamping arm moves from the open position to the closed position.

Figure 35 is a side view of another embodiment of the leaf clamp including the movable and expandable cover illustrated in the distal position.

Figure 36 is a side view of the leaflet clamp of Figure 26, illustrating the active leaflet engagement mechanism in the proximal position of the extended configuration.

Figures 37 and 38 are side views of another embodiment of a leaflet clamp including an active leaflet engagement mechanism with multiple raised protrusions.

Figure 39 illustrates an embodiment of a leaf clamp coupled to a delivery system, wherein the clamping arm of the leaf clamp extends distally relative to the delivery system.

Figure 40 illustrates an embodiment of a leaflet clamp coupled to a delivery system, wherein the clamping arm of the leaflet clamp extends proximally relative to the delivery system.

Figure 41 illustrates another embodiment of a leaf clamp coupled to a delivery system, wherein its clamping arm extends proximally relative to the delivery system.

Figures 42 and 43 illustrate another embodiment of a leaflet clamp that includes a tissue aggregation region.

Figures 44 and 45 schematically illustrate the function of the tissue aggregation region of the leaflet clamp in Figure 42.

Figure 46 illustrates the leaflet clamps of Figures 42 and 43, with the clamping arms in the closed position and the leaflets positioned in the tissue aggregation area.

Figure 47 illustrates another embodiment of a leaf clamp including a helical member disposed within a tubular central member.

Figure 48 illustrates another embodiment of a leaf clamp including a spiral member arranged around a clamping arm.

Figure 49 is a perspective view of another embodiment of a delivery system that can be used in conjunction with any of the leaf clamps described herein.

Figure 50 is an enlarged view of the distal portion of the delivery device of Figure 49.

Detailed Implementation

For the purposes of this specification, certain aspects, advantages, and novel features of embodiments of this disclosure are described herein. The disclosed methods, apparatuses, and systems should not be construed as limiting in any way. Rather, this disclosure relates to all novel and non-obvious features and aspects of the various disclosed embodiments, their individual use, and various combinations and sub-combinations of each other. The methods, apparatuses, and systems are not limited to any particular aspect or feature or combination thereof, and the disclosed embodiments do not require the existence of any one or more specific advantages or problems solved.

Features, integers, properties, compounds, chemical moieties, or groups described in connection with a particular aspect, embodiment, or example should be understood to be applicable to any other aspect, embodiment, or example described herein, unless incompatible therewith. All features disclosed in this specification (including any appended claims, abstract, and drawings) and/or all steps of any method or process so disclosed may be combined in any combination, except where at least some of such features and/or steps are mutually exclusive combinations. The invention is not limited to the details of any disclosed embodiments. The invention extends to any novel feature or any novel combination of features disclosed in this specification (including any appended claims, abstract, and drawings), or any novel step or any novel combination of steps in any method or process so disclosed.

Although some operations in the disclosed methods are described in a specific sequential order for ease of presentation, it should be understood that this description includes rearrangement unless the specific language described below requires a particular order. For example, operations described sequentially may be rearranged or performed simultaneously in some cases. Furthermore, for simplicity, the accompanying drawings may not show the various ways in which the disclosed methods can be combined with other methods. In addition, the description sometimes uses terms such as "provide" or "implement" to describe the disclosed methods. These terms are higher-level concepts of the actual operations performed. The actual operations corresponding to these terms may vary depending on the specific implementation and are readily discernible to those skilled in the art.

As used in this application and claims, the singular forms “a,” “an,” and “the” include the plural forms unless the context clearly specifies otherwise. Furthermore, the term “comprising” means “including.” Additionally, the terms “coupled” and “associated” generally mean electrically, electromagnetically, and/or physically (e.g., mechanically or chemically) coupled or linked, and do not exclude the presence of intermediate elements between coupled or associated items in the absence of specific contrasting language.

As used herein, the term "proximal" refers to the location, orientation, or portion of the device that is closer to the user and further away from the implantation site. As used herein, the term "distal" refers to the location, orientation, or portion of the device that is further away from the user and closer to the implantation site. Thus, for example, proximal movement of the 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" refer to axes extending in the proximal and distal directions, respectively, unless otherwise explicitly defined.

As used herein, the terms “monolithic” and “integral construction” refer to a construction that does not include any welds, fasteners or other means used to secure the individually formed sheets of material to each other.

Figures 1-3 illustrate a representative embodiment of the leaflet clamp 100, which includes a central elongated member or shaft 102, a first clamping arm 104 and a second clamping arm 106, and a tubular member 108 (also referred to as a "cover" or "shroud") coaxially disposed on the elongated member 102. The elongated member 102 may have a proximal portion 110 and a distal portion 112, and may define a lumen 114 through which the guidewire can be inserted (shown as a dashed line in Figure 1).

Clamping arms 104 and 106 may be coupled to the proximal portion 110 of the elongated member and may move between an open position (Figures 1 and 2) and a closed position (Figure 3). In the illustrated embodiment, clamping arms 104 and 106 extend distally from the proximal portion 110 of the elongated member and may be shaped such that they are radially curved away from the elongated member 102 when in the open position. In some embodiments, clamping arms 104 and 106 may have a curved cross-sectional profile (in a plane perpendicular to the longitudinal axis of the elongated member 102) such that they are substantially flush with the elongated member 102 when in the closed position.

As shown in Figure 2, clamping arms 104 and 106 can extend from an annular collar 116 coaxially located on the proximal portion 110 of the elongated member 102. In some embodiments, clamping arms 104 and 106 may be integrally formed with collar 116, or may be separately formed and attached to collar 116 as needed. For example, in some embodiments, clamping arms 104 and 106 may be hinged. Annular collar 116 may also include one or more radially extending protrusions or tabs 118 extending from collar 116 and configured to prevent rotation of tubular member 108 relative to elongated member 102 (i.e., indexing of tubular member 108), as further described below. In some embodiments, clamping arms 104 and 106 and/or collar 116 may be made of any biocompatible material, such as, for example, titanium, nitinol or nitinol, plastic, stainless steel, etc.

The tubular member 108 may be coaxially disposed on the elongated member 102 and is axially movable relative to the elongated 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 may include a proximal portion 120 and a first extension 122 and a second extension 124 corresponding to the first clamping arm 104 and the second clamping arm 106. The tubular member 108 may also define a slot 126 between the extensions 122 and 124, which can receive a tab 118 of the collar 116 when the tubular member 108 is in the second position, as shown in FIG. 3. In this way, when the tubular member 108 moves distally from the first position to the second position, the tab 118 can travel in the corresponding slot 126, and the first extension 122 and the second extension 124 can contact the first clamping arm 104 and the second clamping arm 106 respectively, and cause the clamping arms 104 and 106 to enter a closed position.

Clamping arms 104 and 106 and elongated member 102 can define corresponding leaflet receiving regions, configured to receive heart valve leaflets when clamping arms 104 and 106 are in the open position. For example, first clamping arm 104 and elongated member 102 can define a first leaflet receiving region 128, and second clamping arm 106 together with elongated member 102 can define a second leaflet receiving region 130, as shown in Figures 1 and 2. During implantation, leaflet clamp 100 can be positioned adjacent to the commissure of the heart valve such that one valve leaflet is received in the first leaflet receiving region 128, and the corresponding valve leaflet is received in the second leaflet receiving region 130, while elongated member 102 extends between the leaflets. In this way, when the clamping arms 104 and 106 move from the open position to the closed position, the leaflet can be captured between the first clamping arm 104 and the elongated member 102 and the second clamping arm 106 and the elongated member 102, respectively, as further described below.

In some embodiments, the proximal portion 110 of the elongated member 102 may include a locking or retaining feature 132 for holding the tubular member 108 in a second position. In the illustrated embodiment, the retaining feature 132 may include a ridge 134 located on the proximal end of the elongated member 102. The ridge 134 may have a diameter larger than the diameter of the tubular member 108, such that if the proximal portion 120 of the tubular member 108 is advanced over the ridge 134, the ridge 134 will cause the proximal portion 120 to expand beyond its natural diameter. Once the proximal portion 120 of the tubular member 108 has been advanced distal to the ridge 134, the proximal portion 120 can return to its natural (non-deflected and non-expanded) diameter, such that the ridge 134 restricts the tubular member 108 from moving proximally beyond the ridge 134, thereby locking the clamping arms 104 and 106 in a closed position.

In this manner, once the leaflet clamp 100 has been positioned relative to the leaflet of the heart valve in the desired location, the tubular member 108 can be fully advanced to the second position, thereby locking the tubular member 108 distal to the bulge 134 and thus locking the clamping arms 104 and 106 in the closed position, such that the leaflet clamp 100 is held on the leaflet. In some embodiments, the proximal portion 120 of the tubular member 108 may define one or more notches 136 to allow the walls of the proximal portion 120 to flare radially outward as it passes over the bulge 134, thereby allowing the proximal portion 120 to pass over the bulge 134 more easily. The walls of the proximal portion 120 can then return to their natural diameter distal to the bulge 134.

In some embodiments, the leaflet clamp 100 may include an active or passive leaflet engagement mechanism disposed on the elongated member 102 to assist in engaging and retaining the leaflets of the heart valve in respective first leaflet receiving regions 128 and second leaflet receiving regions 130 as the clamping arms 104 and 106 move from an open position to a closed position. For example, the leaflet clamp 100 may include a passive leaflet engagement mechanism of a cover 138 configured to be disposed on the distal portion 112 of the elongated member 102. The cover 138 may have a textured surface such that the cover 138 can frictionally engage the leaflets when they are received in the leaflet receiving regions 128 and 130, and retain the leaflets in the respective leaflet receiving regions 128 and 130 as the clamping arms 104 and 106 move from an open position to a closed position. In some embodiments, the cover 138 may include a woven or braided fabric, or may be a polymer tube or sleeve configured to be disposed on the distal portion 112 of the elongated member 102. In some embodiments, the cover 136 may be made of any of a variety of natural or synthetic materials, such as polyethylene terephthalate (PET), foam, silicone, or stitching material.

Figures 4 and 5 illustrate a leaflet clamp 100 coupled to a representative embodiment delivery system 150, which can be used to deliver a leaflet clamp (such as leaflet clamp 100) to a desired heart valve. The delivery system 150 may include a main handle body 152 comprising an external catheter or shaft 154 movable between proximal and distal positions, control buttons 156, 158, and two grip portions 160. Referring to Figure 5, the delivery system 150 may further include an actuator catheter or shaft 162 coaxially disposed within the external catheter 154 and coupled to a tubular member 108, such that proximal or distal movement of the actuator catheter 162 in the direction indicated by arrow 164 causes corresponding proximal or distal movement of the tubular member 108 relative to the elongated member 102 and the gripping arms 104, 106.

In some embodiments, the actuator conduit 162 may include a coupling device 166 to couple the actuator conduit 162 to the proximal portion 120 of the tubular member 108, as shown in Figures 6-8. In some embodiments, the coupling device 166 may include a pair of angled tabs 163 and 165, which are coupled to the actuator conduit 162 at their respective proximal ends and are shaped such that the corresponding angled portions 163A and 165A of the tabs 163 and 165 extend radially beyond the diameter of the actuator conduit 162, as shown in Figure 7. In this way, the tabs 163 and 165 can function as springs such that when the outer conduit 154 is positioned around the distal end of the actuator conduit 162 (i.e., in the distal position), the inner surface of the outer conduit 154 can contact the angled portions 163A and 165A of the tabs 163 and 165, and deflect them radially inward relative to the actuator conduit 162, as shown in Figure 8. In this manner, tabs 163 and 165 can extend into corresponding openings defined in the proximal portion 120 of the tubular member 108, such as opening 167 shown in Figures 9 and 10. This allows tabs 163 and 165 of the actuator member 162 to releasably engage the tubular member 108, such that proximal and/or distal movement of the actuator conduit 162 causes proximal and/or distal movement of the tubular member 108, and thus causes movement of the clamping arms 104 and 106 between open and closed positions. In an alternative embodiment, the actuator conduit 162 can be coupled to the tubular member 108 by any suitable coupling mechanism, including, for example, threads, clamps, ball and detent systems, etc.

The proximal movement of the actuator conduit 162, and therefore the proximal movement of the tubular member 108, can be limited by one or more of various controllable motion limiting mechanisms (e.g., cams, hard stops, pull tabs, etc.) to reduce the risk of locking the tubular member 108 in a distal position before successful placement of the leaflet clamp 100 (i.e., preventing the proximal portion 120 of the tubular member 108 from moving distally relative to the bulge 134 of the elongated member 102). One or more motion limiting mechanisms can establish motion limiting stops beyond which the distal movement of the actuator conduit 162, outer conduit 154, and tubular member 108, as coupling units, is constrained relative to the inner axis 168. In the illustrated embodiment, such motion limiting mechanisms can be controlled by a control button 156. For example, actuation of control button 156 allows actuator catheter 162, external catheter 154, and tubular member 108 to move past a limiting stop, thereby allowing the proximal portion 120 of tubular member 108 to move distally over the bulge 134 of elongated member 102, thus locking clamping arms 104 and 106 in the closed position. Therefore, after leaflet clamp 100 has been clamped to the leaflet of the heart valve, control button 156 can be actuated to allow actuator catheter 162, external catheter 154, and tubular member 108 to move distally past the limiting stop, thereby locking clamping arms 104 and 106 in the closed position.

Proximal movement of the external catheter 154 can also be restricted by one or more controllable movement limiting mechanisms to reduce the risk of unintended release of the tubular member 108 from the actuator catheter 162 during placement of the leaflet clamp 100. In the illustrated embodiment, such movement limiting mechanisms can be controlled by a control button 158. For example, actuation of the control button 158 can allow proximal movement of the external catheter 154 relative to the actuator catheter 162, exposing the tabs 163 and 165, allowing them to return to their natural, undeflected shape and disengage from the tubular member 108. This can release the tubular member 108 from the delivery system 150. Thus, after the leaflet clamp 100 has been finally placed in the heart valve, the control button 158 can be actuated to allow proximal movement of the external catheter 154 and release of the actuator catheter 162 from the tubular member 108.

For the embodiment shown in FIG5, the delivery system 150 may further include an inner member or shaft 168 coaxially disposed within the actuator conduit 162 and coupled at one end to the proximal portion 110 of the elongated member 102 and at the opposite end to a shank member 170. In the illustrated embodiment, the inner member 168 may be threadedly coupled to the proximal portion 110 of the elongated member 102 such that rotation of the shank member 170 in the direction indicated by arrow 172 may disengage the inner member 168 from the elongated member 102. For example, the distal portion of the inner member 168 may have a male thread that threadedly engages a female thread formed on the inner surface of the proximal portion 110 of the elongated member 102. In this way, after the leaflet clamp 100 is finally placed in the heart valve, the actuator member 162 can be disengaged from the tubular member 108, the inner member 168 can be disengaged from the elongated member 102, and the delivery system 150 can retract, leaving the leaflet clamp 100 in place.

In some embodiments, the diameter of the external catheter 154 may be approximately 10 French, and the system 150 may be configured for use with a guidewire (e.g., through the lumen 114 of the elongated member 102). In some embodiments, the respective catheters 154, 162, and internal member 168 of the delivery system 150 may be flexible or rigid, as needed. In some embodiments, the delivery system 150 may include a steering element to assist in the placement and orientation of the leaflet clamp 100 relative to the heart valve. Moreover, it should be understood that, for illustrative purposes, the respective catheters 154, 162, and internal member 168 of the delivery system 150 are shown in reduced lengths and may be of any suitable length.

In use, the delivery system 150 can be introduced into the patient's vascular system (e.g., via the femoral artery or other suitable access point) using any of a variety of delivery techniques and percutaneously advanced to the patient's heart, with the clamping arms 104 and 106 in a closed position (but not locked). In a transfemoral procedure, the delivery device can be inserted retrogradely through the femoral artery and aorta to reach the heart (typically, but not exclusively, for deploying clamps on the leaflets of the aortic or mitral valve). Similarly, the delivery device can be inserted antegradely through the femoral vein and vena cava to reach the right side of the heart (typically, but not exclusively, for deploying clamps on the leaflets of the pulmonary or tricuspid valve). In a transventricular procedure, the delivery device can be inserted through a surgical incision formed at a bare point on the chest and lower anterior ventricular wall (typically, but not exclusively, for deploying clamps on the leaflets of the aortic or mitral valve). Similarly, the delivery device can be inserted through a surgical incision on the right ventricular wall to access the pulmonary or tricuspid valve. In a transatrial procedure, the delivery device can be inserted through a surgical incision formed in the wall of the left or right atrium to access the natural valves on the left or right side of the heart, respectively. In a transaortic procedure, the delivery device can be inserted through a surgical incision formed in the ascending aorta and advanced toward the heart (typically, but not exclusively, for deploying clamps on the leaflets of the aortic or mitral valve). In a transseptal procedure, the delivery device can be advanced into the right atrium, for example, via the femoral vein, and by separating the septum of the right and left ventricles (typically, but not exclusively, for deploying clamps on the leaflets of the aortic or mitral valve). Further details of delivery techniques for accessing the natural valves of the heart are disclosed in U.S. Patent Publication No. 2014/0067052.

Once near the desired heart valve location, clamping arms 104 and 106 are extended via retraction actuator catheter 162, thereby retracting tubular member 108 relative to clamping arms 104 and 106. Leaflet clamp 100 can then be positioned relative to the valve fusion and can be advanced and/or retracted distally as needed to position leaflet clamp 100 such that one fused leaflet is received in a first leaflet receiving region 128 and a second fused leaflet is received in a second leaflet receiving region 130. When leaflet clamp 100 is properly positioned, actuator catheter 162 can be advanced such that tubular member 108 moves distally relative to elongated member 102 and pushes clamping arms 104 and 106 toward the closed position.

With clamping arms 104 and 106 in the closed position, the clamping strength of the leaflet clamp 100 can be tested by pulling the delivery system 150 proximally. As used herein, the terms “clamping holding force” and “clamping strength” refer to the force in the proximal direction that the leaflet clamp can withstand without detaching from the leaflet of the heart valve when the clamping arms are in the closed position. In some embodiments, the delivery system 150 may include a strain gauge or other device to measure the force applied to the leaflet clamp 100. In some embodiments, the leaflet clamp 100 can withstand a proximal force application between 1 N and about 10 N while maintaining clamping to the valve leaflet. For example, if the leaflet clamp 100 is not properly positioned, or if the leaflet clamp 100 does not exhibit adequate clamping strength when clamped to the leaflet, the tubular member 108 may be retracted by proximal movement of the actuator catheter 162, causing the clamping arms 104 and 106 to reopen and allowing the leaflet clamp 100 to be repositioned. When the leaflet clamp 100 is properly positioned relative to the valve leaflet, the actuator member 162 can advance the tubular member 108 to the distal side of the bulge 134, thereby locking the clamping arms 104 and 106 in the closed position. The inner member 168 can then be disengaged from the elongated member 102, and the delivery system 150 can be retracted, thereby holding the leaflet clamp 100 in the proper position on the valve leaflet.

Leaflet clip 100 and any other leaflet clip embodiments described herein can be used to treat valvular insufficiency or remodel the valve annulus of a heart valve. For example, Figure 11 illustrates three leaflet clips 202, 204, 206 similar to the leaflet clip 100 of Figure 1 located in a natural aortic valve 200. The natural aortic valve 200 may include three valve leaflets 210, 212, 214 attached to a valve annulus 216. Valve leaflets 210 and 212 may form a first commissure 218, leaflets 212 and 214 may form a second commissure 220, and leaflets 210 and 214 may form a third commissure 222. Leaflet clips 202, 204, and 206 are shown located 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 located near the wall of the valve annulus 216. In this way, leaflet clips 202, 204, and 206 can improve the engagement of leaflets 210, 212, and 214 at the respective commissures 218, 220, and 222, thereby reducing regurgitation through valve 200 due to valvular insufficiency. Furthermore, although leaflet clamps 202, 204, and 206 are shown as clamping adjacent valve annulus 216 to the corresponding valve leaflet, leaflet clamps 202, 204, and 206 can be clamped to the valve leaflet at any suitable location along the leaflet as needed, including clamping to the valve leaflet at the center of the commissure.

Leaflet clamps 202, 204, and 206 can also reshape the annulus 216 of the valve 200 to reduce the dilation of the annulus 216 and/or correct any abnormalities in the shape of the annulus 216. For example, Figure 12 schematically illustrates the reshaping of the annulus 216 using leaflet clamps such as clamps 202, 204, and 206 to reduce its diameter from an dilated annulus diameter D1 to a target or reduced annulus diameter D2. This reshaping or diameter reduction can be achieved by reducing the circumference of the annulus 216, as shown in Figures 13 and 14.

For example, Figure 13 illustrates a leaflet clamp 202 with its clamping arms in the open position. Hash marks 230 and 232 are shown on the tissue to indicate the initial distance between the clamping arms and an initial reference for the circumference of the valve annulus. Dashed line 234 represents the natural profile of the valve tip. Figure 14 illustrates a leaflet clamp 202 with its clamping arms in the closed position, such that the tissue of the valve annulus 216 adjacent to clamp 202 is gathered and clamped together by the leaflet clamp. This reduces the circumference of the valve annulus 216, thereby reducing the diameter of the valve annulus 216, as indicated by the movement of hash marks 230 and 232 toward each other.

The effect of this diameter reduction is further illustrated in Figures 15, 16, and 17, where the distances a, b, and c between the three points 302, 304, and 306, schematically indicated in Figure 15 and shown on the annulus of the heart valve 300 in Figures 16 and 17, are reduced after the three leaflet clamps 308, 310, and 312 are applied to the fusion of the heart valve 300. In some embodiments, the diameter of the annulus can be reduced from an expansion diameter of about 29 mm to a target diameter of about 25 mm. In some embodiments, the diameter of the annulus can be reduced from about 10% to about 50%. In some embodiments, the diameter of the annulus can be reduced by about 14%.

Any of the leaflet clips disclosed herein can also be used in conjunction with one or more support rings, as shown in Figures 18 and 19. Figure 19 illustrates three leaflet clips 402, 404, and 406 clamped to the aortic valve 400 as seen from the aortic root. Figure 18 illustrates the position of the support ring 408 on the ventricular side of the aortic valve 400, which can cooperate with the leaflet clips 402, 404, and 406 to reshape and/or reduce the diameter of the aortic valve 400, as shown in Figure 19. As shown, an extension 410 of the central axis of each of the leaflet clips in the left ventricle can extend through a corresponding opening in the ring 408. Alternatively, the ring 408 can be positioned around the extension 410. The leaflet clips 402, 404, and 406 can also be used, together with or independently of any support device or structure, to achieve folds or folds in the fusion, as shown in Figure 19.

As described above, any leaflet clip disclosed herein can be used to treat valvular insufficiency or remodel the annulus of the mitral and/or tricuspid valves, in addition to treating or remodeling 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 and 506 of the mitral valve 500. As shown in Figures 20 and 21, the relatively small width of the clamping arm 508 of the leaflet clip 500 relative to the chordae tendineae of the mitral valve 500 can reduce interference of the clamping arm 508 with the chordae tendineae during and after implantation of the leaflet clip 502. In use, one or more leaflet clips 502 can be placed at or near the center of the leaflets 504 and 506 or near the annulus, as needed.

Figures 22 and 23 illustrate leaflet clips 602, similar to the leaflet clip 100 of Figure 1, placed on the leaflets 604, 606 of the tricuspid valve 600. As described above, the leaflet clip 602, alone or in combination with one or more additional leaflet clips, can be used to reduce valvular insufficiency and/or reshape the valve annulus.

Figures 24-32 illustrate various configurations of the clamping arms that can be used in conjunction with any leaf clamp disclosed herein. Furthermore, although the leaf clamps of Figures 24-26 are illustrated without a central elongated member, it should be understood that any leaf clamp described herein may or may not include an elongated member (e.g., member 102) as needed. Figure 24 illustrates a leaf clamp 700 in which clamping arms 702, 704 exhibit the bends indicated at 702A and 704A, and extend outward without exhibiting any significant further curvature (i.e., clamping arms 702, 704 are relatively straight).

Figure 25 illustrates a leaflet clamp 800, in which clamping arms 802 and 804 each show two bends, with the first bend indicated at 802A and 804A, and the second bend indicated at 802B and 804B, such that clamping arms 802 and 804 include corresponding distal portions 806 and 808, which are angled away from the tubular member 810 at an angle α greater than about 45 degrees.

Figure 26 illustrates a leaflet clamp 900, wherein clamping arms 902 and 904 have curved distal portions 906 and 908.

Figure 27 illustrates a leaf clamp 1000 similar to the leaf clamp 800 of Figure 25, wherein clamping arms 1002 and 1004 show a first bend indicated at 1002A and 1004A and a second bend indicated at 1002B and 1004B, such that the distal portions 1006 and 1008 of clamping arms 1002 and 1004 are angled away from the tubular member 1010 at an angle α of less than about 45 degrees.

Figure 28 illustrates a leaflet clamp 1100, wherein clamping arms 1102 and 1104 extend distally from the elongated member 1106 before bending away from it, thereby reducing the area of the corresponding leaflet receiving regions 1108 and 1110.

Figures 29 and 30 illustrate embodiments of a clamping arm 1600 including one or more openings 1602 defined in the clamping arm 1600. The clamping arm 1600 may include openings 1602 located at the distal portion of the clamping arm 1600 as shown in Figure 29, or spaced apart along the length of the clamping arm 1600 as shown in Figure 30. The clamping arm 1600 may include a fibrous cover or sleeve 1604, which may be disposed around the distal portion of the clamping arm 1600 as shown in Figure 29, or along the entire length of the clamping arm 1600 as shown in Figure 30. The cover 1604 may be held on the clamping arm 1600 by sutures 1606, which may be disposed around the cover 1604 and received or fastened through the plurality of openings 1602 to hold the cover 1604 on the clamping arm 1600. In this way, the cover 1604 can be used to frictionally engage tissue of the leaflets of a heart valve while reducing the risk of leaflet damage. In an alternative embodiment, the clamping arm 1600 may include any suitable number of openings 1602 located at any suitable position along the length of the clamping arm, and may include a cover extending along the clamping arm 1600 in any suitable proportion. The cover 1604 may be made of a suitable biocompatible fabric such as PET.

Figure 31 illustrates another embodiment of a clamping arm 1700 including a proximal portion 1702 and a distal portion 1704. In the illustrated embodiment, the clamping arm 1700 may be tapered, such that the proximal portion 1702 has a first diameter or width _W1 , and the distal portion 1704 has a second diameter or width _W2 , wherein the first diameter _W1 is larger than the second diameter _W2 . This allows the distal portion 1704 to have greater flexibility relative to the proximal portion 1702 in the direction indicated by arrow 1706, which can reduce the risk of damaging the tissue of the natural heart valve leaflet. The distal portion 1704 may also include a ridge 1708, which has a relatively large diameter relative to the diameter _W2 of the distal portion 1704, which can reduce the risk of puncturing the natural leaflet during or after implantation of the leaflet clamp.

Figure 32 illustrates another embodiment of the clamping arm 1800, including an inner member 1802 and an overmolded cover 1804 (i.e., an "insertmolding"). The cover 1804 can be made of any biocompatible polymer (e.g., silicone, ePTFE, etc.) and can include textures, indentations, or other surface features to facilitate the engagement and retention of the tissue of the natural valve leaflet. The inner member 1802 can be made of metallic or polymeric materials as needed.

Figure 33 illustrates another embodiment of a leaflet clamp 1200 similar to the leaflet clamp 100 of Figure 1. The leaflet clamp 1200 may include an elongated member 1202 and two clamping arms 1204, 1206. For illustrative purposes, a leaflet clamp 1200 without the tubular member (shroud) is illustrated. The leaflet clamp 1200 may include a passive leaflet engagement mechanism configured as a tube or sleeve 1208 and disposed on the distal portion 1210 of the elongated member 1202. The sleeve 1208 may be made of, for example, polyester and may be configured to frictionally engage and retain the leaflet of the heart valve between the respective clamping arms 1204 and 1206 and the elongated member 1202 when the clamping arms move from an open position to a closed position.

Figure 34 schematically illustrates the relative positions of the natural leaflets 1302 and 1304 of the heart valve 1306 with respect to the clamping arms 1308 and 1310 of the leaflet clamp 1300 before and after the clamping arms 1308 and 1310 move from the open position to the closed position. In a manner similar to the leaflet clamp embodiment described above, distal movement of the tubular member 1316 from a first position (indicated by solid lines) to a second position (indicated by dashed lines) can cause the clamping arms 1308 and 1310 to move from the open position to the closed position. When the leaflets 1302 and 1304 are received in the respective leaflet receiving regions 1312 and 1314, the ends of the clamping arms 1308 and 1310 can contact the leaflets 1302 and 1304 at corresponding points A along the respective leaflets 1302 and 1304. In some embodiments, when the clamping arms 1308 and 1310 move from the open position to the closed position, the leaflets 1302 and 1304 can slide such that when the clamping arms 1308 and 1310 are in the closed position, they contact the leaflets 1302 and 1304 at the respective points B. Depending on the required degree of clamping strength, in some cases it may be advantageous to retain a larger proportion of the leaflets 1302 and 1304 within the leaflet receiving areas 1312 and 1314 when the clamping arms move from the open position to the closed position.

Therefore, Figures 35 and 36 illustrate another embodiment of a leaflet clamp 1400 including an elongated member 1402 and two clamping arms 1404, 1406. The leaflet clamp 1400 may include an active leaflet engagement mechanism 1408 configured to accommodate a woven or braided covering 1410 disposed on the elongated member 1402 between a fixed proximal retaining member 1412 and a distal retaining member 1414, movable between a distal position and a proximal position. When the leaflet clamp 1400 is positioned such that natural leaflets 1416 and 1418 are received in corresponding leaflet receiving regions 1420 and 1422, the distal retaining member 1414 may (e.g., by actuation of a member disposed within the elongated member 1402) move proximally in the direction indicated by arrow 1424 in Figure 36. Movement of the distal retaining member 1414 toward the proximal retaining member 1412 causes the cover 1410 to gather/bunch, radially expanding or protruding away from the elongated member 1402, and engaging leaflets 1416 and 1418 between the cover 1410 and the corresponding clamping arms 1404, 1406. When the distal retaining member 1414 is in the proximal position, the tubular member 1426 can be advanced distally, causing the clamping arms 1404 and 1406 to move from the open position to the closed position. In this way, when the clamping arms 1404 and 1406 move to the closed position, the leaflets 1416 and 1418 are held in the corresponding leaflet receiving areas 1420 and 1422, resulting in a larger proportion of the leaflets being held against the elongated member 1402 by the leaflet clamp 1400, thereby resulting in stronger gripping of the leaflets and improved performance of the leaflet clamp 1400. Furthermore, when they move to the closed position, the leaflet engagement mechanism 1408 can reduce the sliding of leaflets 1416 and 1418 through the clamping arms 1404 and 1406, which helps to ensure that a larger proportion of leaflets 1416 and 1418 remain in the leaflet receiving areas 1420 and 1422, and increases the holding force of the leaflet clamp 1400 on leaflets 1416 and 1418.

Figures 37 and 38 illustrate another embodiment of a leaflet clamp 1500 including an elongated member 1502, two clamping arms 1504, 1506, and a sheath 1526. The leaflet clamp 1500 may include an active leaflet engagement mechanism 1508 configured as a sleeve 1510, wherein the sleeve 1510 includes a plurality of ridges 1512 axially spaced apart from each other along the sleeve 1510. The sleeve 1510 is movable relative to the clamping arms 1504 and 1506 between a distal and a proximal position, as indicated by arrow 1514 (Figure 37). The ridges 1512 may have corresponding edge portions 1516 configured to engage or grip natural leaflets 1518 and 1520 disposed in corresponding leaflet receiving regions 1522 and 1524, as depicted in Figure 38, when the sleeve 1510 is moved proximally. Therefore, when the clamping arms 1504 and 1506 are moved to the closed position (e.g., by advancing the sheath 1526 on the clamping arms), the edge portion 1516 of the ridge 1512 can engage and hold the leaflets 1518 and 1520 within the leaflet receiving areas 1522 and 1524, thereby preventing the leaflets from slipping out of the leaflet receiving areas. This can result in a larger proportion of the leaflets 1518 and 1520 being held against the elongated member 1502 by the clamping arms 1504 and 1506, resulting in stronger gripping of the leaflets and improved performance of the leaflet clamp 1500.

In the illustrated embodiment, sleeve 1510 includes three ridges 1512. However, it should be understood that sleeve 1510 may include any suitable number of ridges having any suitable size and spacing relative to each other. In some embodiments, sleeve 1510 may be disposed on elongated member 1502, which may be movable proximally and/or distally. In alternative embodiments, sleeve 1510 may be disposed on a shaft or conduit coaxially disposed within (or outside) elongated member 1502 and actuated independently from outside the body. In some embodiments, sleeve 1510 may be made of suitable natural or synthetic materials, such as, for example, polyester. In some embodiments, the space between ridges 1512 may serve as a tissue aggregation area (see description with reference to Figures 42-46), contributing to increased clamping strength of leaflet clamp 1500.

Figures 39 and 40 schematically illustrate alternative coupling orientations of the leaflet gripper relative to the delivery system. In Figure 39, a leaflet gripper 1900 coupled to delivery system 1902 is shown, with gripping arms 1904 and 1906 extending distally relative to delivery system 1902. Figure 40 illustrates a leaflet gripper 2000 coupled to delivery system 2002, with gripping arms 2004 and 2006 extending proximally relative to delivery system 2002. It should be understood that these coupling orientations can be applied to any leaflet gripper described herein and can be advantageous for the various delivery techniques described above.

Figure 41 illustrates another embodiment of the leaflet clamp 2100, coupled to the delivery system 2102 such that clamping arms 2104 and 2106 extend proximally relative to the delivery system 2102, similar to the embodiment of Figure 40. The leaflet clamp 2100 may include a tubular member 2108, coaxially arranged about an elongated member 2110, and movable between a distal and a proximal position, such that clamping arms 2104 and 2106 are each pushed from an open position to a closed position by the tubular member 2108. The tubular member 2108 may be coupled to an actuator member 2112 via a coupling device 2114, shown as a threaded connection between the distal end of the tubular member 2108 and the actuator member 2112. The actuator member 2112 may extend coaxially through the elongated member 2110 and may move relative to the elongated member 2110 in the direction indicated by arrow 2113, such that proximal or distal movement of the actuator member 2112 causes corresponding proximal or distal movement of the tubular member 2108.

The elongated member 2110 can be coupled to the inner conduit 2116 via tabs 2118 and 2120, wherein tabs 2118 and 2120 are received in corresponding openings 2122 and 2124 of the elongated member 2110. Tabs 2118 and 2120 can be held in the openings 2122 and 2124 via an adjacent outer conduit 2126, which is coaxially disposed around the inner conduit 2116 and configured such that the inner surface of the outer conduit 2126 contacts the tabs 2118 and 2120, and pushes or deflects the tabs 2118 and 2120 into the openings 2122 and 2124 of the elongated member 2110. In this way, the leaflet clamp 2100 can remain coupled to the delivery system 2102, while allowing proximal and distal movements of the actuator component 2112 and the tubular component 2108 to facilitate the placement and/or repositioning of the clamping arms 2104 and 2106.

In the illustrated embodiment, the elongated member 2110 may include tabs or extensions 2128 and 2130 near its distal end, which may be received in corresponding openings 2132 and 2134 defined in the tubular member 2108. In this way, after the final placement of the leaflet clamp, the actuator member 2112 can move proximally relative to the elongated member 2110, causing the tubular member 2108 to deflect the clamping arms 2104 and 2106 to a closed position, and the tabs 2128 and 2130 are received in the openings 2132 and 2134 of the tubular member 2108, thereby locking the tubular member 2108 in the proximal position and thus locking the clamping arms 2104 and 2106 in the closed position. The outer conduit 2126 can then be moved proximally in the direction of arrow 2136, allowing the tabs 2118 and 2120 of the inner conduit 2116 to disengage from the elongated member 2110. The actuator member 2112 can then be rotated, for example, in the direction indicated by arrow 2138, thereby disengaging the threaded coupling 2114 between the actuator member 2112 and the tubular member 2108. The delivery system 2102 can then be retracted, leaving the leaflet clamp 2100 in place.

Figures 42 and 43 illustrate another embodiment of the leaflet clamp 2200, which includes an elongated member 2202, a first clamping arm 2204 and a second clamping arm 2206, and a tubular member 2208 coaxially disposed relative to the elongated member 2202. The elongated member 2202 may have a proximal portion 2210 and a distal portion 2212, wherein the diameter _D1 of the distal portion 2212 is larger than the diameter _D2 of the proximal portion 2210. In this way, when the clamping arms are in the closed position, the clamping arms 2204 and 2206 may define corresponding tissue aggregation regions 2214 and 2215 between the respective clamping arms 2204 and 2206 and the elongated member 2202, as shown in Figure 43. In the illustrated embodiment, the tissue aggregation regions 2214 and 2215 may have corresponding width dimensions _X1 and _X2 , and height dimensions _H1 and _H2 . In some embodiments, the width dimensions X1 and X2 may vary along the height of the respective tissue aggregation region due to, for example, the angle between the respective clamping arms 2204 and 2206 and the elongated member 2202 when the clamping arms 2204 and 2206 are in the closed position and/or the flexion in the clamping arms ₂₂₀₄ and ₂₂₀₆ .

The clamping arms 2204 and 2206 may also define corresponding tissue compression regions 2220 and 2222 between the clamping arms 2204 and 2206 and the elongated member 2202, the corresponding tissue compression regions 2220 and 2222 having corresponding width dimensions _W1 and _W2 . In some embodiments, due to the angle between the corresponding clamping arms 2204 and 2206 and the elongated member 2202 and/or the buckling in the clamping arms 2204 and 2206, the dimensions _W1 and _W2 may vary along the length of the corresponding tissue compression regions 2220 and 2222, as described above.

Tissue aggregation regions 2214 and 2215 can be positioned adjacent to the proximal portion of the elongated member 2202 and can be configured such that the distal portions of the natural leaflets of the heart valve extend into the tissue aggregation regions 2214 and 2215. In the tissue aggregation regions 2214 and 2215, the tissue at the free end of the leaflet can aggregate or converge, while the lower portion of the leaflet can be simultaneously engaged or clamped between the clamping arms 2204 and 2206 and the elongated member 2202 in the tissue compression regions 2220 and 2222. This can result in a difference in the thickness of the leaflet tissue in the relatively unrestricted and/or uncompressed tissue aggregation regions 2214 and 2215 compared to the thickness of the leaflet tissue in the tissue compression regions 2220 and 2222. This difference in thickness can significantly increase the clamping strength of the leaflet clamp 2200, thereby increasing the leaflet clamp's ability to retain the leaflet clamped to the working heart valve.

For example, Figures 44 and 45 schematically illustrate the mechanics of tissue aggregation and tissue compression regions. In Figure 44, the free end portion 2304 of the leaflet 2302 is clamped between the clamping arm 2306 and the elongated member 2308 of the leaflet clamp 2300. In the unconstrained state, the leaflet 2302 may have a thickness T, and the leaflet clamp 2300 may be configured such that when the clamping arm 2306 is in the closed position, the clamping arm 2306 and the elongated member 2308 define a tissue compression region 2310 with a size D (corresponding to tissue compression regions 2220 and 2222 of Figures 42 and 43). In a typical example, the distance D between the elongated member 2308 and the clamping arm 2306 may be configured to compress the tissue of the leaflet 2302, thereby reducing the thickness T of the leaflet tissue by approximately 50% relative to the thickness of the unconstrained tissue. Therefore, for a valve leaflet with a thickness T of approximately 1 mm, the tissue compression region 2310 can be configured to compress the tissue disposed in region 2310, reducing its thickness T to approximately 0.5 mm. This reduction in thickness typically results in a greater holding force of the leaflet tissue between the clamping arm 2306 and the elongated member 2308, while minimizing the risk of damage to the leaflet 2302.

As described above, Figure 44 illustrates the free end portion 2304 of the leaflet 2302 disposed in the tissue aggregation region 2310. In a typical example, this arrangement can withstand a proximal force of approximately 1 N. However, by configuring the leaflet clamp 2300 such that the free end portion 2304 of the leaflet 2302 is relatively unconstrained, such as when disposed in the tissue aggregation region while the middle portion 2312 of the leaflet 2302 is compressed in the tissue compression region 2310, the clamping strength of the leaflet clamp can be significantly increased. Figure 45 schematically illustrates this arrangement, wherein the middle portion 2312 of the leaflet 2302 is clamped in the leaflet compression region 2310 such that its thickness is reduced to approximately 0.5 T, while the free end portion 2304 of the leaflet 2302 is disposed in the tissue aggregation region 2314 and is allowed to retain its natural thickness T. In some embodiments, this arrangement allows the lobule clamp 2300 to withstand a proximal force of approximately 4 N, which can significantly improve the clamping strength of the lobule clamp. The use of features such as the tissue aggregation regions 2214 and 2215 can also promote the long-term stability of the lobule clamp 2200 after implantation by neutralizing tissue growth around the clamp 2200 through the cultivation of tissue aggregation regions 2214 and 2215.

Returning to the leaflet clamp 2200, Figure 46 illustrates the leaflet clamp 2200, where clamping arms 2204 and 2206 are in the closed position, and leaflets 2216 and 2218 are captured in tissue compression regions 2220 and 2222. The tissue compression regions 2220 and 2222 can be configured such that portions of leaflets 2216 and 2218 disposed in regions 2220 and 2222 can be compressed, reducing their respective thickness T to approximately 0.5T, as described above. Simultaneously, tissue aggregation regions 2214 and 2215 can be configured such that the free end portions 2224 and 2226 of leaflets 2216 and 2218 are allowed to remain to their natural thickness T, which can significantly increase the clamping strength of the leaflet clamp 2200.

In some embodiments, the width dimensions _X1 , _X2 and height dimensions _H1 , _H2 of tissue aggregation regions 2214 and 2215 and/or the width dimensions _W1 , _W2 of tissue compression regions 2220 and 2222 can be designed according to the thickness T of valve leaflets 2218 and 2220. For example, in some embodiments, the width dimensions _X1 , _X2 of tissue aggregation regions 2214 and 2215 can range from about 1T to about 2T. In some embodiments, the width dimensions _X1 , X2 of tissue aggregation regions 2214 and 2215 can be about 1T. In some embodiments, the height dimensions _H1 , _H2 of tissue aggregation regions 2214 _and 2215 can range from about 1T to about 2T. In some embodiments, the width dimensions _W1 , _W2 of tissue compression regions 2220 and 2222 can be about 0.5T, as described above.

Figure 47 illustrates another embodiment of the leaflet clamp 2400, which includes a tubular central member 2402 having a proximal portion 2404 and a distal portion 2406. The distal portion 2406 may include a first clamping arm 2408 and a second clamping arm 2410 movable between an open position and a closed position. The clamping arms 2408 and 2410 may define a leaflet receiving region 2411 between them, which may receive leaflets 2416 and 2418 of the heart valve. The leaflet clamp 2400 may also include a tubular outer member 2412, which is coaxially disposed about the central member 2402 and movable relative to the central member 2402 between a proximal position and a distal position. The outer member 2412 may be configured such that when it moves from the proximal position to the distal position, the inner surface of the outer member 2412 contacts the clamping arms 2408 and 2410 and pushes or deflects them from the open position to the closed position.

The leaflet clamp 2400 may further include a helical member 2414, shown in the shape of a screw cone. The helical member 2414 may be disposed within the lumen of the central member 2402 and may move relative to the central member 2402 between a proximal position and a distal position. In this way, when leaflets 2416 and 2418 are received in the leaflet receiving region 2411 and the clamping arms 2408 and 2410 are in the closed position, the helical member 2414 may be advanced distally through the lumen of the central member 2402 to engage leaflets 2416 and 2418. This may result in folds in leaflets 2416 and 2418 and increase the clamping strength of the leaflet clamp 2400. In some embodiments, the helical member 2414 may pierce leaflets 2416 and 2418, or may engage leaflets 2416 and 2418 as needed without piercing them. In some embodiments, the spiral member 2414 may also include a detachable coupling mechanism 2420 for coupling the leaf clamp 2400 to the delivery device.

Figure 48 illustrates another embodiment of a leaflet clamp 2500 including a central member 2502 having two clamping arms 2504 and 2506 extending distally therefrom. The clamping arms 2504 and 2506 are movable between an open position and a closed position and may define a leaflet receiving region 2508 that can receive leaflets 2510 and 2512. The leaflet clamp 2500 may further include a helical member 2514 movable between a proximal position and a distal position. In some embodiments, the helical member 2514 may include, for example, a helically wound wire. When the helical member 2514 is in the distal position, it may be positioned around the clamping arms 2510 and 2512 and configured to limit radial movement of the clamping arms 2504 and 2506 relative to each other. In this way, the helical member 2514 can hold leaflets 2510 and 2512 between clamping arms 2504 and 2506, thereby holding the leaflet clamp 2500 on the heart valve.

Figures 49 and 50 illustrate another embodiment of a delivery device 2600 that can be used in conjunction with any leaflet clamp described herein. The delivery device may include a handle body 2602 comprising a proximal handle portion 2604 and a distal handle portion 2606. The delivery device may further include an outer conduit 2608 coupled to the distal handle portion 2606, and an intermediate or clamp release conduit 2610 coaxially disposed within the outer conduit 2608 and coupled to the proximal handle portion 2604. The clamp release conduit 2610 can be moved proximally and distally relative to the outer conduit 2608 by means of proximal and distal movement of the proximal handle portion 2604. The delivery device may further include a clamp holding conduit 2612 coaxially disposed within the clamp release conduit 2610 and coupled to the distal handle portion 2606. In the illustrated embodiment, the clamp holding conduit 2612 may include tab portions 2614 and 2616 (FIG. 50) that engage openings in the tubular member 2618 of the leaflet clamp 2620 when covered and deflected inward by the clamp release conduit 2610, similar to the embodiments in FIG. 1-10 above.

The delivery device may also include an inner shaft or conduit 2622 (FIG. 40) coaxially disposed within the clamp holding conduit 2612. The inner shaft 2622 may be coupled to the proximal portion of the central elongated member 2624 (FIG. 50) of the leaflet clamp, such that proximal and distal movements of the inner shaft 2622 cause corresponding proximal and distal movements of the elongated member 2624 relative to the tubular member 2618. By moving the central elongated member 2624 of the leaflet clamp relative to the tubular member 2618, clamping arms 2626 and 2628 may be pulled proximally into and deflected into the tubular member 2618, thereby moving the clamping arms to a closed position, or pushed distally from the tubular member, causing the clamping arms to return to their undeflected open state. Alternatively, the inner shaft 2622 may be coupled to the tubular member 2618, such that longitudinal movement of the inner shaft causes corresponding longitudinal movement of the tubular member to open and close the clamping arms.

In the illustrated embodiment, the inner shaft 2622 may further include a shank portion 2630 for realizing proximal and distal movements of the inner shaft. The inner shaft 2622 may also define a lumen in communication with the lumen of the elongated member 2624 for receiving the guidewire. The shank portion 2602 may also include a locking feature to prevent accidental separation of the proximal and distal shank portions (e.g., during shipment).

In the illustrated embodiment, the clamp release catheter 2610 may include a pin or protrusion 2632 that may move with the clamp release catheter in a track or guide portion 2634 defined in the outer catheter 2608. In the illustrated embodiment, the guide portion 2634 may include a circumferentially extending distal portion 2636, a longitudinally extending intermediate portion 2638, and a longitudinally extending proximal portion 2640 that is circumferentially offset from the intermediate portion; however, other configurations are also possible.

When the device is inserted into the body and advanced toward the heart, the proximal stem portion 2604 and the distal stem portion 2606 can be adjacent to each other, and the clamp release catheter 2610 can be positioned distally such that the protrusion 2632 is located in the distal portion 2636 of the guide portion 2634, and the leaflet clamp is located within the lumen of the clamp release catheter. When the distal end of the device reaches the desired implantation site, the proximal stem portion 2604 can be rotated, causing a corresponding rotation of the clamp release catheter 2610. This allows the protrusion 2632 of the clamp release catheter to move into the intermediate portion 2638 of the guide portion 2634. The proximal stem portion 2604 can then be pulled proximally or retracted, separating the proximal stem portion from the distal stem portion 2606, thereby causing corresponding proximal movement of the clamp release catheter 2610 and the protrusion 2632 in the intermediate portion 2638 of the guide portion. The clamp release catheter 2610 can retract a sufficient distance to expose the clamping arms of the leaflet clamp 2620, but will not expose the tabs 2614 and 2616 of the clamp-holding catheter and allow the leaflet clamp to be opened and released from the delivery device.

Then, through proximal and distal movements of the inner shaft 2622, the leaflet clamp 2620 can be clamped onto and/or released from the natural leaflet of the target heart valve. Once the leaflet clamp has been properly positioned onto the natural leaflet, the clamping arms 2626 and 2628 can be locked in the closed position. The proximal stem portion 2604 can then be rotated, causing the protrusion 2632 to move into the distal portion 2640 of the guide portion 2634. This allows the stem portion 2604 to move further proximal, exposing the tabs 2614 and 2616 of the clamp release catheter 2612, releasing the leaflet clamp from the delivery device.

The delivery devices shown in Figures 49 and 50 can be adapted for use with transapical delivery procedures. However, it should be understood that the devices of Figures 49 and 50 can be adapted for use with any suitable delivery procedure, including transfemoral procedures, transatrial procedures, transseptal procedures, etc.

Given the many possible embodiments in 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 considered as limiting the scope of this disclosure. Rather, the scope of this disclosure is defined by the appended claims.

Claims (10)

1. A clamp for attaching to two leaflets of a heart valve, the clamp comprising: An elongated member configured to be positioned between the two leaflets of the heart valve; A first clamping arm and a second clamping arm are coupled to a first portion of the elongated member and extend toward a second portion of the elongated member; When the first clamping arm is in the open position, as the first clamping arm extends from the first portion toward the second portion to form a first leaflet receiving area, the first clamping arm extends radially away from the elongated member. When the second clamping arm is in the open position, as the second clamping arm extends from the first portion toward the second portion to form a second leaflet receiving area, the second clamping arm extends radially away from the elongated member; and A passive leaflet engagement mechanism placed on the elongated member. 2. The clamp of claim 1, wherein the passive leaflet engagement mechanism is configured to engage and retain the leaflets of the heart valve in the respective first leaflet receiving region and second leaflet receiving region as the first clamping arm and the second clamping arm move from the open position to the closed position. 3. The clamp according to claim 1, wherein the passive leaflet engagement mechanism includes a cover placed on the elongated member. 4. The clamp according to claim 3, wherein the cover is made of polyethylene terephthalate, foam, or stitching material. 5. The clamp according to claim 1, wherein the first clamping arm and the second clamping arm are hinged. 6. The clamp according to claim 1, wherein the width of the second portion is greater than the width of the first portion. 7. An assembly comprising a clamp according to claim 1 coupled to a delivery system. 8. A clamp for attaching to two leaflets of a heart valve, the clamp comprising: An elongated member configured to be positioned between the two leaflets of the heart valve; A first clamping arm and a second clamping arm are coupled to a first portion of the elongated member and extend toward a second portion of the elongated member; When the first clamping arm is in the open position, as the first clamping arm extends from the first portion toward the second portion to form a first leaflet receiving area, the first clamping arm extends radially away from the elongated member. When the second clamping arm is in the open position, as the second clamping arm extends from the first portion toward the second portion to form a second leaflet receiving area, the second clamping arm extends radially away from the elongated member. Woven or braided covering placed on the elongated member; and The woven or braided covering protrudes radially away from the elongated member. 9. The clamp of claim 8, wherein the woven or braided cover is positioned between the proximal retaining member and the distal retaining member. 10. The clamp according to claim 8, wherein the cover is made of polyethylene terephthalate, foam, or stitching material.