阅读说明：本技术 用于小叶折叠或捕获的方法和装置 (Methods and devices for leaflet folding or capturing ) 是由 O·威茨曼 E·阿蒂亚斯 H·科恩泽马克 D·迈蒙 于 2021-05-27 设计创作，主要内容包括：本文的名称为用于小叶折叠或捕获的方法和装置。本文中公开了用于折叠和/或捕获心脏瓣膜的小叶的方法和工具。在假体心脏瓣膜的安装之前或期间,现有瓣膜结构的小叶的部分能够被远侧地定位和/或被折叠在其本身上。现有瓣膜结构可以是原生心脏瓣膜或之前植入的假体心脏瓣膜。当现有瓣膜结构在主动脉位置处时,假体心脏瓣膜能够随后被安装在现有瓣膜结构内,使得小叶被维持在避免阻塞到冠状动脉中的一个或多个的血流的位置中。(The name herein is a method and device for leaflet folding or capturing. Disclosed herein are methods and tools for folding and/or capturing leaflets of a heart valve. Portions of leaflets of existing valve structures can be positioned distally and/or folded over onto themselves prior to or during installation of the prosthetic heart valve. The existing valve structure may be a native heart valve or a previously implanted prosthetic heart valve. When the existing valve structure is at the aortic position, the prosthetic heart valve can then be installed within the existing valve structure such that the leaflets are maintained in a position that avoids obstructing blood flow to one or more of the coronary arteries.)

1. A prosthetic heart valve, comprising:

a ring frame expandable from a crimped state to a deployed state;

a first valve structure formed from a leaflet assembly comprising a plurality of leaflets, the first valve structure disposed within and attached to the annular frame; and

a leaflet capturing member disposed along an exterior of the annular frame and coupled to the annular frame at opposing ends thereof, the leaflet capturing member extending along an axial direction of the annular frame, the leaflet capturing member including a distal portion, a proximal portion, and an intermediate portion between and coupled to the distal and proximal portions by respective connecting portions,

wherein the leaflet capturing member is configured to change shape after the annular frame is expanded to the deployed state so as to capture free ends of leaflets of the existing second valve structure between the intermediate portion and the distal portion.

2. The prosthetic heart valve of claim 1, further comprising additional leaflet capturing members disposed at different locations along a circumference of the annular frame.

3. The prosthetic heart valve of any preceding claim, wherein each leaflet capturing member comprises a substantially straight rod extending along the axial direction prior to expansion of the annular frame.

4. The prosthetic heart valve of any preceding claim, wherein at least the proximal portion of each leaflet capturing member has an open cell structure that allows blood to flow therethrough.

5. The prosthetic heart valve of any preceding claim, wherein at least one of the connection portions comprises a weakened area.

6. The prosthetic heart valve of any preceding claim, wherein at least one of the connection portions comprises a region having a narrowed cross-section compared to the distal portion, the proximal portion, and/or the intermediate portion.

7. The prosthetic heart valve of any preceding claim, wherein at least one of the connection portions comprises a notched or fluted region.

8. The prosthetic heart valve of any preceding claim, wherein the leaflet capturing member is formed of a metal or a biocompatible polymer.

9. The prosthetic heart valve of any preceding claim, wherein the leaflet capturing member is configured such that:

prior to expansion of the ring frame, a first connection portion coupling the proximal portion to the intermediate portion is disposed proximal to a second connection portion coupling the distal portion to the intermediate portion; and

after expansion of the ring frame, the first connection portion is disposed distal to the second connection portion.

10. A system for leaflet capture, the system comprising:

a locking device comprising first and second members and having an open configuration in which the first and second members are spaced from one another by a gap that is reduced or eliminated in a closed configuration,

wherein, in the open configuration, the gap between the first and second members is configured to receive a portion of a leaflet therein, and

the closed configuration causes the leaflet portion to be captured between the first and second members.

11. The system of claim 10, wherein:

the first member having one or more protruding portions and the second member having one or more recesses, each recess corresponding to one of the protruding portions,

in the open configuration, each protruding portion is separated from a corresponding recess, an

In the closed configuration, each protruding portion is inserted into the corresponding recess.

12. The system of claim 11, wherein each protruding portion is configured to pierce the leaflet portion within the gap when the locking device is transitioned from the open configuration to the closed configuration.

13. The system of any one of claims 10-12, wherein:

the first member having a protruding portion with one or more barb portions,

the second member having a recess with one or more ridges therein,

in the open configuration, the protruding portion is separated from the recessed portion, and

in the closed configuration, the projection is inserted into the recess such that at least one of the barb portions abuts at least one of the ridges so as to resist removal of the projection from the recess.

14. The system of any one of claims 10-13, further comprising an actuator configured to displace the first and second members from the open configuration to the closed configuration.

15. The system of claim 14, wherein the actuator is releasably coupled to the locking device so as to be separated therefrom when the locking device is in the closed configuration.

16. The system of any one of claims 14-15, wherein the actuator comprises a collection portion disposed adjacent the gap in the open configuration and configured to collect a portion of the leaflet into the gap when the locking device is advanced over a free end of the leaflet.

17. The system of any one of claims 14-16, wherein:

the actuator is a scissor-type actuator having a pair of arms coupled via a hinge,

one of the arms is coupled to the first member of the locking device, and

the other of the arms is coupled to the second member of the locking device.

18. The system of any of claims 10-17, further comprising:

a collection member disposed adjacent the gap and between the locking device and the actuator in the open configuration,

wherein the collection member is configured to collect a portion of the leaflet into the gap when the locking member is advanced over the free end of the leaflet.

19. The system of claim 18, wherein the collection means includes a portion of at least one of the arms adjacent the hinge.

20. The system of claim 18, wherein the collection member comprises a suture, wire, cable, or other flexible member extending between the first and second locking device members.

21. The system of claim 18, wherein the collection member is supported on one or more portions of the actuator.

22. The system of any of claims 10-21, wherein the first and second members are configured to be coupled together in the closed configuration by a snap fit.

23. A system for leaflet capture, the system comprising:

a clamp member configured to transition between a biased state and a free state, the clamp member having a first end and a second end connected by an intermediate portion,

wherein in the free state the intermediate portion assumes a curved configuration defining a capture area for a portion in which leaflets are retained, and

in the biased state, the intermediate portion assumes a straight or substantially straight configuration.

24. The system of claim 23, wherein the free state is such that the first and second ends are disposed in proximity to each other.

25. The system of any of claims 23-24, wherein the clamp member is formed of a flexible material.

26. The system of claim 25, wherein the clamp member is formed from a spring metal or a shape memory alloy.

27. The system of any one of claims 26, wherein the clamp member is formed from steel, cobalt-chromium alloy, or nickel-titanium alloy.

28. The system of any one of claims 23-27, wherein at least a portion of the clamp member comprises a biocompatible surface coating.

29. The system of any one of claims 23-28, further comprising a delivery catheter having a lumen configured to receive the clamp member in the biased state therein, the first end of the clamp member being closer to the distal end of the delivery catheter than the second end of the clamp member.

30. The system of claim 29, further comprising a deployment member within the delivery catheter, the deployment member configured to translate distally along an axial direction of the lumen to push the second member to deploy the clamp member from the distal end of the delivery catheter.

31. The system according to any of claims 23-30, wherein in the free state, the clamp member has a substantially Ω -shape.

32. The system of any of claims 23-31, wherein in the free state, a gap between the first and second ends is less than a thickness of the leaflet.

33. A system for leaflet folding, the system comprising:

a delivery sheath configured to be disposed within and delivered through a vasculature of a patient;

a leaflet-engaging member disposed within the delivery sheath and axially movable therein, the leaflet-engaging member having a pointed tip at an axial end thereof; and

a positioning member disposed within the delivery sheath and axially movable therein, the positioning member having an atraumatic end portion.

34. The system of claim 33, wherein the delivery sheath has a lumen extending therethrough, and the leaflet-engaging member, the positioning member, or both are disposed within the lumen and axially movable therein.

35. The system of any one of claims 33-34, wherein the positioning member comprises a wire, cable, or catheter.

36. The system of any of claims 33-35, wherein the atraumatic end portion of the positioning member comprises a loop.

37. The system of claim 36, wherein the ring comprises a circular shape, an oval shape, an elliptical shape, a C-shape, or a J-shape.

38. The system of any one of claims 36-37, wherein the loop comprises a pair of wires coupled to each other at respective ends.

39. The system of any one of claims 33-38, wherein the pointed tip is configured to pierce a portion of a leaflet in contact therewith.

40. The system of any of claims 33-39, wherein the barbed tip has a barbed configuration with a laterally extending or radially extending (e.g., annular) base.

41. The system of any one of claims 33-40, wherein the leaflet-engaging member comprises a wire or cable.

42. The system according to any one of claims 33-41, wherein the leaflet-engaging member is movable independently of the positioning member.

43. The system of any one of claims 33-42, further comprising:

a second delivery sheath configured to be disposed within and delivered through a vasculature of a patient concurrently with the delivery sheath;

a second leaflet-engaging member disposed within the second delivery sheath and axially movable therein, the second leaflet-engaging member having a second barbed tip at an axial end thereof; and

a second positioning member disposed within the second delivery sheath and having a second atraumatic end portion.

44. A system for leaflet capture, the system comprising:

a clamp member configured to be plastically deformed between an open configuration and a closed configuration, the clamp member having first and second ends connected by an intermediate portion, the first and second ends in the open configuration being spaced from one another by a gap that is reduced or eliminated in the closed configuration,

wherein, in the open configuration, a gap between the first and second ends is configured to receive a portion of a leaflet therein, and

the closed configuration causes the leaflet section to be captured between the first and second ends.

45. The system of claim 44, wherein the clamp member is formed from a metal, a metal alloy, or any combination thereof.

46. The system of claim 45, wherein the clamp member comprises steel or a cobalt-chromium alloy.

47. The system of any one of claims 44-46, wherein at least a portion of the clamp member comprises a biocompatible surface coating.

48. The system of any one of claims 44-47, wherein the first end, the second end, or both comprise a sharp tip for piercing a leaflet, a blunt tip for grasping the leaflet without piercing, a magnetic portion, a female member for receiving a male member of another tip, a male member for inserting into a female member of another tip, or any combination thereof.

49. The system of any one of claims 44-48, further comprising an actuator having a first arm and a second arm, the actuator configured to apply a compressive force that plastically deforms the clamp member from the open configuration to the closed configuration.

50. The system of claim 49, wherein the actuator is releasably coupled to the clamp member so as to be separated therefrom when the clamp member is in the closed configuration.

51. The system of any one of claims 49-50, wherein the actuator comprises forceps, surgical forceps, or a scissor-type actuator.

Technical Field

The present disclosure relates to prosthetic heart valves, and to methods and devices for folding or capturing leaflets of existing valve structures prior to or during implantation of the prosthetic heart valve.

Background

The human heart is afflicted with various valvular diseases. These valve diseases can lead to severe malfunction of the heart, eventually requiring repair of the native valve or replacement of the native valve with a prosthetic valve. There are many known prosthetic devices (e.g., stents) and prosthetic valves, and many known methods of implanting these devices and valves into the human body. Percutaneous and minimally invasive surgical methods, such as Transcatheter Aortic Valve Replacement (TAVR), are used in various procedures to deliver prosthetic medical devices to locations within the body that are not readily accessible by surgery or are desired to be accessed without surgery.

As surgical methods for valve replacement become available for younger patients, patient life may exceed the corresponding life of the implanted prosthetic valve. Valve-in-valve (ViV) procedures have been developed to install a new prosthetic valve within a previously implanted prosthetic valve. However, such procedures may pose a risk of coronary occlusion. In particular, the leaflets of a previously implanted prosthetic valve may obstruct the coronary ostia or otherwise prevent blood flow through the frame of a new prosthetic valve to the coronary ostia. Similar problems may occur when a prosthetic valve is percutaneously expanded within a native heart valve (e.g., when a native leaflet is displaced toward the coronary ostium). Existing methods that rely on tearing existing leaflets require high spatial precision and surgical skill. Furthermore, portions of the torn leaflets may still partially or completely occlude the coronal orifice.

Disclosure of Invention

Embodiments of methods and tools for folding and/or capturing leaflets of a heart valve to avoid or at least reduce the risk of occlusion of a coronary ostium are described herein. In some embodiments, a portion of a leaflet (or portions of a leaflet) is captured and held distal to the ostium of a coronary artery by one or more external features of the prosthetic heart valve during its installation within an existing valve structure (e.g., a native heart valve or a previously implanted prosthetic heart valve). In some embodiments, a portion of the leaflet (or portions of the leaflet) is folded over onto itself and/or held distal to the coronary ostium by one or more sutures, coupling members, locking members, clamp members, and/or barbed gripping members. The prosthetic heart valve can then be installed within the existing valve structure. The captured and/or folded leaflet portion allows blood to flow to the coronary artery, otherwise the coronary ostium may have been blocked by the unaltered leaflet. In other embodiments, a portion of a leaflet (or portions of a leaflet) is captured/folded prior to or during installation of the prosthetic heart valve within an existing valve structure (e.g., a native heart valve or a previously implanted prosthetic heart valve) at a valve location other than an aortic location (e.g., a lung, tricuspid, or mitral valve).

Any of the various innovations of the present disclosure can be used in combination or separately. This abstract is provided to introduce a selection of concepts in a simplified form that are further described below in the specification. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. The foregoing and other objects, features and advantages of the disclosed technology are apparent from the following detailed description taken in conjunction with the accompanying drawings.

Drawings

FIG. 1 shows a cross-sectional view of a native aortic valve.

Fig. 2A shows a side view of a prosthetic heart valve implanted within a native aortic valve annulus.

Fig. 2B shows the implanted prosthetic heart valve of fig. 2A when viewed from the ascending aorta.

Fig. 2C illustrates an exemplary prosthetic valve delivery device that can be used to implant a prosthetic heart valve according to one or more embodiments of the disclosed subject matter.

Fig. 3A-3C illustrate simplified side views during prosthetic valve positioning, expansion, and installation stages, respectively, for leaflet capture according to a first example.

Fig. 4A-4D illustrate simplified side views of catheter positioning, leaflet puncture, suture loop formation and tensioning stages, respectively, for leaflet capture according to a second example.

Fig. 4E illustrates a simplified side view of a tensioning phase using a sliding member according to a variant of the second example.

Fig. 4F illustrates a simplified side view of a suture loop locking stage for leaflet capture according to a second example.

Fig. 4G illustrates a simplified side view of a prosthetic heart valve implanted between leaflets of a native aortic valve after one or more of the native leaflets have been altered.

Fig. 5A-5H illustrate simplified side views of first catheter positioning, distal side first anchor formation, proximal side first anchor formation, second catheter positioning, distal side second anchor formation, proximal side second anchor formation, coupling member sliding and locking stages, respectively, for leaflet capture according to a third example.

Fig. 6A-6B illustrate a capture device according to a fourth example with an actuator in an open configuration and in a closed configuration, respectively.

Fig. 6C-6E illustrate simplified side views of capture device positioning, leaflet collection, and locking stages, respectively, for leaflet capture according to a fourth example.

Fig. 7A illustrates a capturing apparatus according to a fifth example.

Fig. 7B-7D illustrate simplified side views of catheter positioning, capture device partial deployment, and capture device full deployment stages, respectively, for leaflet capture according to a fifth example.

Fig. 8A illustrates a tool for leaflet folding according to a sixth example.

Fig. 8B is a simplified detailed view of the leaflet folding tool of fig. 8A in a distal configuration with spikes.

Fig. 8C-8D are simplified detailed views (side and bottom views, respectively) of the leaflet folding tool of fig. 8A in a distal configuration with barbed spikes.

Fig. 9A-9F illustrate simplified side views of leaflet folding tool positioning, leaflet coaptation, distal positioning of a single leaflet, distal positioning of a plurality of leaflets, prosthetic heart valve positioning, and prosthetic heart valve expansion, respectively, for leaflet folding according to a sixth example.

10A-10B illustrate a deformable capture device in an initial configuration and in a deformed configuration, respectively, according to a seventh example.

Fig. 10C illustrates a deformable capture device with an actuator in a closed configuration, according to a seventh example.

Fig. 11A-11E illustrate simplified side views of capture device positioning, leaflet coaptation, leaflet collection, device deformation, and final locking stages, respectively, for leaflet capture according to a seventh example.

Detailed Description

General considerations of

For purposes of description, certain aspects, advantages, and novel features of embodiments of the disclosure are described herein. The disclosed methods, apparatus, and systems should not be construed as limiting in any way. Rather, the present disclosure is directed to all novel and nonobvious features and aspects of the various disclosed embodiments, alone and in various combinations and subcombinations with one another. The methods, apparatus and systems are not limited to any specific aspect or feature or combination thereof, nor do the disclosed embodiments require that any one or more specific advantages be present or problems be solved. Techniques from any example may be used in combination with techniques described in any one or more of the other examples.

Although the operations of some of the disclosed embodiments are described in a particular, sequential order for convenient presentation, it should be understood that this manner of description encompasses rearrangement, unless a particular order is required by specific language set forth below. For example, in some cases, operations described sequentially may be rearranged or performed concurrently. Moreover, for the sake of simplicity, the attached 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 "implement" to describe the disclosed methods. These terms are high-level abstractions of the actual operations that are performed. The actual operations corresponding to these terms may vary depending on the particular implementation and may be readily discerned by one of ordinary skill in the art.

As used herein, with reference to prosthetic heart valve assemblies to refer to implantation and structure of the prosthetic heart valve, "proximal" refers to a location, direction, or portion of a component of the handle of the delivery system or device that is closer to the user and outside the patient, while "distal" refers to a location, direction, or portion of a component that is further from the user and the handle and closer to the implantation site. The terms "longitudinal" and "axial" refer to an axis extending in the proximal and distal directions, unless expressly defined otherwise.

The terms "axial direction," "radial direction," and "circumferential direction" have been used herein to describe the arrangement and assembly of components relative to the geometry of the frame of the prosthetic heart valve. Such terms have been used for convenience of description, but the disclosed embodiments are not strictly limited to this description. In particular, when a component or action is described with respect to a particular direction, it includes directions parallel to the specified direction and minor deviations therefrom. Thus, the description of the components extending along the axial direction of the frame does not require the components to be aligned with the center of the frame; more precisely, the component can extend substantially in a direction parallel to the central axis of the frame.

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 pieces of material to one another.

As used herein, operations that occur "simultaneously" or "in sync" generally occur simultaneously with one another, but where no specific opposite language exists, delays in the occurrence of operations relative to one another, for example due to spacing between components, are clearly within the scope of the above terms.

As used in this application and the claims, the singular forms "a", "an" and "the" include the plural forms unless the context clearly dictates otherwise. In addition, the term "comprising" means "including". Furthermore, the term "coupled" generally refers to physical, mechanical, chemical, magnetic, and/or electrical coupling or coupling, and in the absence of a particular contrary language, does not preclude the presence of intervening elements between the coupled or associated items. As used herein, "and/or" means "and" or "as well as" and "or".

Directions and other relative references (e.g., inner, outer, upper, lower, etc.) may be used to facilitate the discussion of the figures and principles herein, but are not intended to be limiting. For example, certain terms may be used, such as "inner," "outer," "upper," "lower," "inner," "outer," "top," "bottom," "inner," "outer," "left," "right," and the like. Such terms are used to provide some clarity of description when applicable with respect to the relative relationships, particularly with respect to the illustrated examples. However, such terms are not intended to imply absolute relationships, orientations, and/or orientations. For example, for an object, the object may be turned over, and "up" may be changed to "down". However, it is still the same part and the object is still the same.

Disclosure of numerical ranges should be understood to refer to each discrete point within the range, including the endpoints, unless otherwise indicated. Unless otherwise indicated, all numbers expressing quantities of ingredients, molecular weights, percentages, temperatures, times, and so forth, used in the specification or claims are to be understood as being modified by the term "about. Thus, unless implicitly or explicitly indicated otherwise, or unless the context is properly understood by one of ordinary skill in the art as having a more explicit structure, the numerical parameters set forth are approximations that can depend on the desired properties desired and/or the limits of detection under standard test conditions/methods, as known to those of skill in the art. When directly and explicitly distinguishing embodiments from the prior art discussed, the embodiment values are not approximations unless the word "about" is recited. Whenever "substantially," "approximately," "about," or similar language is explicitly used in connection with a particular value, variations up to and including 10% of that value are contemplated unless explicitly stated otherwise.

Summary of the disclosed technology

Described herein are methods and tools for folding and/or capturing leaflets of a heart valve (e.g., a native heart valve or a previously implanted prosthetic heart valve). In some embodiments, the heart valve is at an aortic position and the folding/capturing is effective to avoid or at least reduce the risk of obstructing blood flow to the coronary arteries. In some embodiments, a portion of a leaflet (or portions of a leaflet) is captured and retained distal (upstream) of a coronary ostium by one or more external features of a prosthetic heart valve during its installation within an existing valve structure (e.g., a native heart valve or a previously implanted prosthetic heart valve). Alternatively or additionally, a portion of the leaflet (or portions of the leaflet) is folded over onto itself and/or held distal (upstream) to the coronary ostium by one or more sutures, coupling members, and/or capture devices (e.g., locking devices, clamp members, drop rods, clamping members). When a new prosthetic heart valve is subsequently installed within the existing valve structure, the captured and/or folded leaflets of the existing valve structure are disposed at a location distal to the coronary ostia, thereby allowing unimpeded flow of blood to the coronary arteries. In other embodiments, the heart valve is at a location other than the aortic location (e.g., a lung, tricuspid, or mitral valve location).

Examples of the disclosed technology

Fig. 1 shows the anatomy of the aortic root of a native valve structure having a plurality of leaflets 38 (e.g., three leaflets, but only two are shown in the simplified illustration of fig. 1) separating the left ventricle 26 from the ascending aorta 20. Fig. 2A-2B illustrate an exemplary prosthetic heart valve 10 implanted within the aortic annulus 18 of a native valve structure. The prosthetic heart valve 10 can be radially compressible/expandable between a compressed configuration for delivery into a patient and an expanded configuration for installation (e.g., as shown in fig. 2A).

The prosthetic heart valve 10 can include an annular stent or frame 12. The frame 12 or components thereof (e.g., struts and/or fasteners) can be made from any of a variety of suitable plastically-expandable materials (e.g., stainless steel, etc.) or self-expanding materials (e.g., nickel-titanium alloys (NiTi), such as nitinol) as are known in the art. Suitable plastically expandable materials that can be used to form the frame 12 include, but are not limited to, stainless steel, biocompatible, high strength alloys (e.g., cobalt-chromium or nickel-cobalt-chromium alloys), polymers, or combinations thereof. In particular embodiments, frame 12 is made of a nickel-cobalt-chromium-molybdenum alloy, such asAlloy (SPS Technologies, jenknown, Pennsylvania) which corresponds to UNS R30035 alloy (encompassed by ASTM F562-02). By weight, the amount of the water-soluble polymer,the alloy/UNS R30035 alloy contains 35% nickel, 35% cobalt, 20% chromium and 10% molybdenum.

When made of a plastically-expandable material, the frame 12 (and thus the prosthetic valve 10) can be crimped (crimped) onto a delivery catheter to a radially collapsed configuration, and then expanded inside the patient by an inflatable balloon or comparable expansion mechanism. When made of a self-expandable material, the frame 12 (and thus the prosthetic valve 10) can be crimped to a radially collapsed configuration and restrained in the collapsed configuration by insertion into a sheath or equivalent mechanism of a delivery catheter. Once inside the body, the prosthetic valve can be advanced from the delivery sheath, which allows the prosthetic valve to expand to its functional size.

Fig. 2C illustrates an exemplary delivery device 200 suitable for delivering a prosthetic heart valve, such as the prosthetic heart valve 10 described herein or any other prosthetic heart valve. The prosthetic valve 10 can be releasably coupled to the delivery apparatus 200, such as via a removable coupling between a distal member of an expansion and locking mechanism of the prosthetic valve 10 and a second actuation member of an actuation assembly of the delivery apparatus 200. The prosthetic valve 10 can include a distal end 224 and a proximal end 226, wherein the proximal end 226 is positioned closer to the handle 204 of the delivery device 200 than the distal end 224, and wherein the distal end 224 is positioned farther from the handle 204 than the proximal end 226. It should be understood that the delivery apparatus 200 can be used to implant prosthetic devices other than prosthetic valves, such as stents or grafts.

In the illustrated example, the delivery device 200 generally includes a handle 204, a first elongate shaft 206 (which in the illustrated embodiment comprises an outer shaft) extending distally from the handle 204, at least one actuator assembly 208 extending distally through the outer shaft 206. In some embodiments, the distal portion 216 of the shaft 206 can be sized to accommodate the prosthetic valve in its radially compressed delivery state during delivery of the prosthetic valve through the vasculature of a patient. In this manner, the distal portion 216 acts as a delivery sheath or capsule for the prosthetic valve during delivery.

The at least one actuator assembly 208 can be configured to radially expand and/or radially collapse the prosthetic valve 10 when actuated, and can be removably coupled to the prosthetic heart valve 10. Although the illustrated example shows two actuator assemblies 208 for purposes of illustration, it should be understood that one actuator 208 can be provided for each actuator of the prosthetic valve. For example, three actuator assemblies 208 can be provided for a prosthetic valve having three actuators. In other examples, there can be a greater or lesser number of actuator assemblies. The actuator assembly 208 can be releasably coupled to the prosthetic valve 10. For example, each actuator assembly 208 can be coupled to a respective actuator of the prosthetic valve 10. Each actuator assembly 208 can contain a support tube, or sleeve, and an actuator member. In some examples, the actuator assembly 208 also includes a locking tool. When actuated, the actuator assembly can transmit a pushing and/or pulling force to a portion of the prosthetic valve to radially expand and collapse the prosthetic valve. The actuator assembly 208 can be at least partially radially disposed within the one or more lumens of the outer shaft 206 and extend axially through the one or more lumens of the outer shaft 206. For example, the actuator assembly 208 can extend through a central lumen of the shaft 206 or through a separate corresponding lumen formed in the shaft 206.

The handle 204 of the delivery apparatus 200 can include one or more control mechanisms (e.g., knobs or other actuation mechanisms) for controlling the various components of the delivery apparatus 200 in order to expand and/or deploy the prosthetic valve 10. For example, the handle 204 includes first, second, and third knobs 210, 212, and 214. The first knob 210 can be a rotatable knob configured to produce axial movement of the outer shaft 206 in a distal and/or proximal direction relative to the prosthetic valve 10 in order to deploy the prosthetic valve from the delivery sheath 216 when the prosthetic valve has been advanced to a position at or near a desired implantation location of the patient's body. For example, rotation of the first knob 210 in a first direction (e.g., clockwise) can proximally retract the sheath 216 relative to the prosthetic valve 10, and rotation of the first knob 210 in a second direction (e.g., counterclockwise) can distally advance the sheath 216. In other examples, the first knob 210 can be actuated by axially sliding or moving the knob 210 (such as pulling and/or pushing the knob). In other examples, actuation of the first knob 210 (rotational or sliding movement of the knob 210) can produce axial movement of the actuator assembly 208 (and thus the prosthetic valve 10) relative to the delivery sheath 216 to advance the prosthetic valve distally from the sheath 216.

The second knob 212 can be a rotatable knob configured to produce radial expansion and/or contraction of the prosthetic valve 10. For example, rotation of the second knob 212 can cause the actuator member and the support tube to move axially relative to each other. Rotation of the second knob 112 in a first direction (e.g., clockwise) can radially expand the prosthetic valve 10, and rotation of the second knob 212 in a second direction (e.g., counterclockwise) can radially collapse the prosthetic valve 10. In other examples, the second knob 212 can be actuated by axially sliding or moving the knob 212 (such as pulling and/or pushing the knob).

The third knob 214 can be a rotatable knob configured to hold the prosthetic heart valve 10 in its expanded configuration. For example, a third knob 214 can be operatively connected to a proximal portion of the locking tool of each actuator assembly 208. Rotation of the third knob in a first direction (e.g., clockwise) can rotate each locking tool to advance the locking nut to its distal position, thereby preventing radial compression of the frame of the prosthetic valve. Rotation of the knob 214 in an opposite direction (e.g., counterclockwise) can cause each locking tool to rotate in an opposite direction to disengage each locking tool from the prosthetic valve 10. In other embodiments, the third knob 214 can be actuated by axially sliding or moving the third knob 214 (such as pulling and/or pushing the knob).

Although not shown, in some embodiments, the handle 204 can include a fourth rotatable knob operatively connected to the proximal end portion of each actuator member. The fourth knob can be configured to rotate each actuator member after rotating the knob to unscrew each actuator member from the proximal portion of the respective actuator. When the locking tool and the actuator member are separated from the prosthetic valve 10, they can be removed from the patient. Further details regarding the structure and operation of a delivery device for delivering and implanting a prosthetic heart valve can be found in U.S. patent nos. 8,652,202, 9,339,384, 9,827,093, 9,867,700, 10,076,638, and 10,806,573, all of which are incorporated herein by reference.

In some embodiments, the struts of the frame 12 may pivot or flex relative to one another to allow radial expansion and contraction of the frame 12. For example, the frame 12 can be formed (e.g., via laser cutting, electroforming, or physical vapor deposition) from a single piece of material (e.g., a metal tube). In other embodiments, the frame 12 can be fabricated by forming individual components (e.g., struts and fasteners of the frame) and then by mechanically assembling and connecting the individual components together.

Further details regarding the structure of the frame 12 and prosthetic heart valve 10 are described in U.S. patent application publication numbers 2012/0123529, 2018/0153689, 2018/0344456, 2019/0060057, 2019/0365530, 2020/0188099, and 2020/0390547, and international application publication numbers WO-2020/081893 and WO-2021/003167, all of which are incorporated herein by reference.

The frame 12 can have a first axial end and a second axial end. In the depicted embodiment, the first axial end (e.g., facing the ascending aorta 20 near the sinotubular junction level 32) can be an outflow end, and the second axial end (e.g., facing the left ventricle 26 near the aortic annulus 18) can be an inflow end. In some embodiments, the outflow end can be coupled to a delivery device for delivering the prosthetic valve to the implantation site. Optionally, the prosthetic valve 10 can be radially crimped over an inflatable balloon of a delivery apparatus for delivery to an implantation site. Implantation of the prosthetic heart valve 10 within the native aortic valve can be via a transfemoral retrograde delivery method. Thus, in the delivery configuration of the prosthetic heart valve, the outflow end is the proximal-most end of the prosthetic valve. In other embodiments, the inflow end can be the most proximal end of the prosthetic heart valve in the delivery configuration, depending on the particular native valve being replaced and the delivery technique being used (e.g., transseptal, transapical, etc.). In some cases, the inflow end can be coupled to a delivery device in a delivery configuration.

The prosthetic valve 10 also includes a valve structure configured to allow blood flow in one direction through the frame 12. The valve structure can be configured to regulate the flow of blood through the prosthetic heart valve 10 from the inflow end to the outflow end. The valve structure can include a leaflet assembly formed, for example, from one or more leaflets 14 (three leaflets illustrated in fig. 2A-2B), the one or more leaflets 14 being made of a flexible material. Adjacent leaflets 14 can be arranged together to form commissures 36, the commissures 36 being coupled (directly or indirectly) to respective portions of the frame 12, whereby at least a portion of the leaflet assembly is secured to the frame 12. The leaflets 14 can be made, in whole or in part, of a biological material, a biocompatible synthetic material, or other such material. Suitable biological materials can include, for example, bovine pericardium (or pericardium from other sources). Further details regarding transcatheter prosthetic heart valves, including the manner in which valve structures can be coupled to the frame 12 of the prosthetic heart valve 10, can be found, for example, in U.S. patent nos. 6,730,118, 7,393,360, 7,510,575, 7,993,394, and 8,652,202, and U.S. patent application publication nos. 2012/0123529, 2018/0325665, and 2019/0365530, all of which are incorporated by reference in their entirety.

The prosthetic heart valve 10 can also include one or more skirts or sealing members. For example, the prosthetic heart valve 10 can include an inner skirt mounted on an inner surface of the frame 12 (shown in fig. 2A-2B) and/or an outer skirt 16 mounted on an outer surface of the frame 12. The inner skirt can be a circumferential inner skirt that spans the entire circumference of the inner surface of the frame 12. The inner skirt can act as a sealing member to prevent or reduce paravalvular leakage (e.g., when the valve is placed at the implantation site), and as an attachment surface to anchor a portion of the leaflets 14 to the frame 12. The outer skirt 16 can act as a sealing member by sealing the tissue of the native valve annulus 18 and helping to reduce paravalvular leakage through the prosthetic valve 10. The inner and outer skirts can be formed of any of a variety of suitable biocompatible materials, including any of a variety of synthetic materials (e.g., polyethylene terephthalate (PET)) or natural materials (e.g., pericardial tissue). The inner and outer skirts can be mounted to the frame using stitches, adhesives, welding, and/or other means for attaching the skirts to the frame. Further details regarding inner and outer skirts and techniques for assembling leaflets to the inner skirt and the skirt to the frame are disclosed in U.S. patent application publication numbers 2012/0123529, 2019/0192296, and 2019/0365530, and international application publication numbers WO-2020/159783 and WO-2020/198273, all of which are incorporated herein by reference.

With existing implanted prosthetic valves, the valve structure may naturally degrade over time, thereby requiring repair or replacement in order to maintain adequate cardiac function. In a valve-in-valve (ViV) procedure, a new prosthetic heart valve is installed within an existing, degenerated prosthetic heart valve in order to restore proper function. However, the ViV procedure may pose an increased risk of obstruction of the coronary arteries 22, 24. Specifically, installation of the new prosthetic heart valve within the valve structure of the existing prosthetic heart valve can displace the leaflets of the existing heart valve outward, thereby occluding the ostia of the coronary arteries 22, 24. In addition, because the leaflets of existing heart valves are disposed outside the frame of the new prosthetic valve, they can cover the outer surface of the frame, thereby creating a substantially impermeable tubular structure that blocks the opening 34 in the frame 12. In some patient anatomies (e.g., when outflow of the valve 10 is at the Sinotubular (STJ) level 32 and the diameter of the valve 10 is similar to the STJ diameter such that the frame 12 touches or is very close to the aortic wall 30 at the STJ level 32), the leaflets of existing valve structures may compromise the ability to enter the coronary arteries 22, 24 or perfuse through the valve frame 12 to the coronary arteries 22, 24 during the diastole phase of the cardiac cycle. Similar problems may occur in some patient anatomies when the prosthetic heart valve 10 is percutaneously expanded within the native valve to displace the native leaflets 38 outward toward the coronary ostia.

To avoid obstructing blood flow to the coronary arteries 22, 24, the leaflets of the existing heart valve (whether a native aortic valve or a previously implanted prosthetic valve) can be captured and/or folded before or during implantation of the new prosthetic heart valve within the existing valve structure. In some embodiments, the new prosthetic heart valve can include one or more components on the exterior of the valve frame. The components can be designed to capture and position one, some, or all of the existing valve structures away from the level of the coronary arteries when the prosthetic heart valve is installed, thereby maintaining vascular access to the arteries.

For example, fig. 3A-3C illustrate a prosthetic heart valve 10 including a leaflet capture member 304 for repositioning one or more leaflets 38 of an existing valve structure (e.g., a native heart valve in the illustrated example or a previously implanted prosthetic heart valve in a non-illustrated example). The leaflet capturing member 304 can be attached to the frame 12 of the prosthetic heart valve 10, for example, via an attachment 306 at a proximal end and via an attachment 308 at a distal end. For example, the attachments 306, 308 can include sutures, rigid attachment members (e.g., brackets or fasteners), and/or coupling materials (e.g., welding, adhesives, or epoxies) extending between the respective capture members 304 and corresponding portions of the frame 12. Otherwise, the leaflet capturing member 304 may be free to move between the attachments 306, 308 independently of the valve frame 12.

In the description of the disclosed embodiments, the methods and devices are described in the context of methods using retrograde delivery to a native aortic valve. Thus, the term "proximal" of a prosthetic valve (or other device) or component thereof is used to refer to its outflow end, and the term "distal" of a prosthetic valve (or other device) or component thereof is used to refer to its inflow end. However, it should be noted that if delivered to the aortic valve in the opposite direction (e.g., transapically), the outflow end of the prosthetic valve would be distal and the inflow end of the prosthetic valve would be proximal during delivery. Thus, in the present application, the term "proximal" is intended to refer to the "outflow end" and the term "distal" is intended to refer to the "inflow end" when the prosthetic valve is implanted at the aortic location. Similarly, the terms "distal side" and "distal" as used herein to describe portions of a component or anatomical structure are intended to refer to "upstream side" and "upstream", while the terms "proximal side" and "proximal" as used herein to describe portions of a component or anatomical structure are intended to refer to "downstream side" and "downstream". Additionally, any of the methods and devices described herein can be applied to any native valve of the heart (aortic, mitral tricuspid, and pulmonary) or a prosthetic valve previously implanted within any native valve of the heart using any known technique that can involve accessing the native valve in a retrograde or anterograde direction.

Each leaflet capturing member 304 can have a middle portion 312, the middle portion 312 being connected at its proximal end to an upper portion by a first flex portion 310 and at its distal end to a lower portion 318 by a second flex portion 314. For example, each flexure 310, 314 can include a weakened, notched or fluted portion, or a region with a narrowed cross-section. In some embodiments, the leaflet capturing members 304 can be formed as substantially straight rods extending along the axial direction of the valve 10. Optionally, the leaflet capturing member 304 can have a cell-like open configuration over at least a portion thereof (e.g., the portion between the attachment member 306 and the first curved portion 310) so as to allow blood to flow therethrough or other access to the coronary arteries 22, 24. The cell-shaped opening configuration of the leaflet capturing member 304 can have a similar configuration as the cell-shaped opening configuration of the frame 12 of the prosthetic heart valve 10 and be aligned with the cell-shaped opening configuration of the frame 12 of the prosthetic heart valve 10 (e.g., similar in size/shape to the opening 34 in the frame 12 and/or aligned with the opening 34 in the frame 12).

In some embodiments, each leaflet capturing member 304 can be disposed at a location along the circumferential direction of the valve 10 that corresponds to a commissure of the valve structure of the prosthetic valve, e.g., on a side of the frame 12 directly opposite where the commissure is attached to the frame 12. In other embodiments, the leaflet capturing members 304 can be disposed at other locations, for example, at locations along the circumferential direction of the valve 10 that correspond to the location of the ostia of the coronary arteries 22, 24 once the valve 10 is implanted. Although two leaflet capturing members 304 are illustrated, fewer or additional members 304 are possible, for example, the leaflet capturing members 304 correspond to each leaflet of an existing valve structure. In addition, although illustrated as axially extending rods in the figures, other shapes for the leaflet capturing member 304 are possible in accordance with one or more contemplated embodiments.

Fig. 3A shows the heart valve 10 in an initial crimped state within an existing valve structure (e.g., a native aortic valve). The leaflet capturing member 304 can have a substantially straight longitudinal configuration and can be positioned to contact a portion of a leaflet (e.g., the free end 42 of the leaflet 38). As the heart valve 10 is radially expanded, the heart valve 10 contracts along its axis, thereby compressing the leaflet capturing member 304 via the attachments 306, 308. As the attachments 306, 308 approach each other during expansion of the valve 10, axial pressure can be exerted on the leaflet capturing member 304. Under the application of axial pressure, flex portions 310 may be configured to deflect radially outward and flex portions 314 may be configured to deflect radially inward, as illustrated in fig. 3B. The folding of the leaflet capturing member 304 about the flex points 310, 314 can form a pocket 316 between the middle portion 312 and the lower portion 318 of the leaflet capturing member 304. In particular, the intermediate portion 312 is rotatable about the second flex portion 314 such that the first flex portion 310 is disposed closer to the distal end 12a of the prosthetic heart valve 10 than the second flex portion 312. As the heart valve 10 is further expanded to its final configuration, in which the outer wall of the valve frame 12 contacts surrounding structure (e.g., the native annulus or the frame of a previously installed prosthetic valve), the middle portion 312 approaches the lower portion 318 such that the free ends 42 of the leaflets 38 (or other portions of each leaflet) fold over on themselves and are captured within the pockets 316. Thus, when the heart valve 10 is fully installed, the leaflets 38 are spaced apart from the coronary arteries 22, 24, as shown in fig. 3C.

In some embodiments, flexible fibers (e.g., sutures, wires, or filaments) can be used to fold the leaflets over themselves and capture the folded leaflets in a position that avoids occluding the corresponding coronary ostia. The flexible fibers can pierce the leaflets at their distal ends and can bypass the free ends of the leaflets. The end of the fiber can be tied to itself with a sliding knot, thereby forming an annulus containing the leaflet portion between the punctured portion and the free end therein. Sliding the knot in a distal direction (e.g., toward an existing heart valve) can reduce the size of the annulus, which causes the leaflet portion therein to curl or fold over on itself. Upon achieving sufficient compression of the leaflets (e.g., a reduction in size and/or a position that will not occlude the coronary ostia when the prosthetic heart valve is installed within the existing valve structure), the knots can be locked in place to retain the leaflets therein, and a new prosthetic heart valve can then be installed.

Fig. 4A-4G illustrate an exemplary method for folding and/or capturing leaflets using a suture. As shown in fig. 4A, the delivery catheter 402 can be advanced from the ascending aorta 20 toward one of the leaflets 38 of an existing valve structure (e.g., a native aortic valve in the illustrated example or a previously installed prosthetic heart valve in the non-illustrated example). For example, the delivery catheter 402 can be positioned with its end facing the first portion of one of the leaflets 38. The first portion can be closer to the annulus 18 than the free ends 42 of the leaflets 38, and preferably distal to the ostium of the coronary artery 22. In some embodiments, the first portion of the leaflets 38 can be circumferentially aligned with the ostia of the coronary arteries 22 (e.g., aligned or substantially aligned along the same radial vector extending from the center of the existing valve structure when viewed from the ascending aorta 20).

A needle 406 having a suture 404 attached thereto can be disposed within the delivery catheter 402. When the delivery catheter 402 is positioned adjacent the first portion of the leaflet 38, the needle 406 can be pushed out of the distal end of the delivery catheter 402 to pierce the first portion 408 of the leaflet 38. The needle 406 with the suture 404 thus moves through the first portion 408 to the distal side of the leaflet 38, as shown in fig. 4B. The suture 404 can then be pulled back to the proximal side of the leaflet 38 by moving the needle 406 through the central gap 410 between the free ends 42 of the leaflets 38 of the existing valve structure. The portion 404b of the suture 404 that has passed through the central gap 410 can then be bound over the portion 404a of the suture 404 that has not passed through the first portion 408 of the leaflet 38.

Knot 412 is formed by binding portion 404b to portion 404a, as shown in fig. 4C. The knot 412 and suture portions 404a, 404b define an annulus 414 that encircles a portion of the leaflet 38 between the first portion 408 and the leaflet free end 42. The knot 412 can be formed so as to be slidable along the suture 404. In some embodiments, the configuration of the knot 412 itself allows it to slide along the suture 404, for example, by forming a slip knot or other sliding. Alternatively or additionally, the knot 412 may be initially formed in a relaxed state to allow the knot 412 to slide along the suture 404. The knot 412 can thus be slid distally along the suture 404 toward the valve structure in order to reduce the size of the ring 414. The reduction in size of the ring 414 causes the portion of the leaflet contained therein (i.e., the portion of the leaflet 38 between its free end 42 and the pierced first portion 408) to curl or fold over on itself, as shown in fig. 4D.

In some embodiments, sliding the knot 412 distally toward the valve structure can be accomplished by moving at least one of the knot 412 and the suture 404 relative to the other. For example, the suture 404 can be pulled in a proximal direction, which can tighten the loop 414 and cause the knot 412 to move distally. Alternatively or additionally, the knot 412 can be pushed along the pierced first portion 408 towards the leaflet 38 by a pushing/assisting member (e.g., by a sliding member 416 as shown in fig. 4E). Alternatively or additionally, when the suture 404 is retracted in the proximal direction, the knot 412 can be held in place by a push/assist member (e.g., a positioning member). The sliding member 416 can have a through-hole, channel, or recess through which the suture 404 extends, and can have a portion (e.g., a distal end) configured to abut the knot 412 when the sliding member 416 is brought into contact therewith. For example, the sliding member 416 can be initially disposed on the suture 404 within the delivery catheter 402, and the sliding member 416 can be sized and shaped to be delivered from the distal end of the delivery catheter 402 into the ascending aorta 20. Alternatively, the push/assist member can be the distal portion of the delivery catheter 402 rather than the separate member 416.

The amount of reduction in the size of the ring 414 can be selected such that the folded portions of the leaflets 38 contained therein are positioned distal to the ostium of the coronary artery 22 even when pressed radially outward due to subsequent installation of the prosthetic heart valve within the existing valve structure. Upon achieving a sufficient reduction in the size of the suture loop 414, the knot 412 can be locked in place, as shown in fig. 4F. The locking of the knot 412 can ensure that the captured portion of the leaflet 38 does not deploy during or after installation of the prosthetic heart valve. For example, the knot 412 can be locked in place by manipulation of the knot itself (such as by tightening the knot 412 and/or bonding, fusing, or encircling the suture portions forming the knot 412). Alternatively or additionally, the knot 412 can be locked in place by a separate physical device 418 in contact with the knot 412. In some embodiments, a sliding member 416 can be used to position a locking device 418 in place relative to the knot 412. The locking device 418 may be configured to reconfigure between a sliding configuration (e.g., where the through-hole allows relative movement between the suture 404 and the locking device 418) and a non-sliding configuration (e.g., where the through-hole restricts relative movement between the suture 404 and the locking device 418), for example, by pressing the suture 404 into contact with the sidewalls of the through-hole, alternatively or additionally, the locking device 418 includes a suture clamp or fastener, for example, as described in U.S. patent application publication nos. 2018/0177503 and 2020/0000458, all of which are incorporated herein by reference, in the event the knot 412 is locked in place, the suture 404 can be cut (e.g., at a location proximate to the locking device 418 or at another location proximal to the location of the knot 412) and retracted into the delivery catheter 402, as shown in fig. 4F The cutting tool provided by the separate catheter of (1). Optionally, a portion of the delivery catheter 402 (e.g., the distal end of the catheter 402) can include a cutting element for cutting the suture 404.

The suture loop 414 thus folds a portion of the leaflet 38 and captures it distal to the coronary artery 22, thereby preventing or at least reducing the risk of occlusion of the ostium of the coronary artery 22. If additional capture/folding of one or more leaflets 38 of the existing valve structure is desired, e.g., to prevent or at least reduce the risk of occlusion of the ostium of coronary artery 24, the technique of fig. 4A-4F can be repeated in a similar manner with the same delivery catheter 402 or a different delivery catheter with respect to the next leaflet 38. In such repetition, the portion of the next leaflet 38 that is punctured by the needle 406 and suture 404 can be circumferentially aligned with the ostium of the coronary artery 24 (e.g., aligned or substantially aligned along the same radial vector extending from the center of the existing valve structure when viewed from the ascending aorta 20). Although not discussed in detail above, manipulation of the needle 406 and/or suture 404 within the patient's anatomy, movement of the push/assist member (e.g., slide member 416) or locking device 418, and/or manipulation of the knot 412 (e.g., to move or lock the knot) may be performed using any tool employed in laparoscopic and/or transcatheter cardiac surgery, such as, but not limited to, knot pushers, suture cutters, manipulators, and the like.

When no additional leaflets are desired to be captured, the new prosthetic heart valve in a crimped state can then be advanced to the existing valve structure with the captured leaflets 38. For example, as depicted in fig. 4G, a new prosthetic valve 10 (which can be the valve 10 of fig. 2A or a different prosthetic valve) can be radially crimped over a balloon of the delivery device 450. The delivery catheter 450 can be advanced through the aorta toward the native aortic valve to position the prosthetic valve 10 between the leaflets 38. The new prosthetic valve 10 is then expanded by inflating the balloon of the delivery catheter so that the captured leaflets 38 are disposed on the outer surface of the new valve frame. However, the locked suture loop 414 holds the captured leaflets 38 in a position distal to the coronary arteries 22, 24, thereby allowing blood to flow from the outflow end of the new prosthetic valve to the coronary arteries 22, 24 when the heart valve implantation is complete. Further details of delivery devices and methods for implanting prosthetic valves using the delivery devices are disclosed in U.S. patent nos. 7,780,723, 9,061,119, and 9,339,384 and U.S. patent application publication No. 2017/0065415, all of which are incorporated herein by reference.

In other embodiments, the prosthetic valve 10 can be a self-expandable prosthetic valve that is held in a radially compressed state within a capsule or delivery sheath of a delivery device, such as disclosed in U.S. patent application publication No. 2014/0343670 and U.S. patent No. 8,652,202, all of which are incorporated herein by reference. When the prosthetic valve is positioned between the leaflets 38, the prosthetic valve can be deployed from the delivery sheath, which allows the prosthetic valve to self-expand against the leaflets to a radially expanded state.

In other embodiments, the prosthetic valve 10 can be a mechanically expandable prosthetic valve releasably connected to one or more mechanical actuators of a delivery device, such as disclosed in U.S. patent application publication No. 2018/0153689, U.S. application No. 62/990,299, and international application No. PCT/US2020/063104, all of which are incorporated herein by reference. The prosthetic valve is held in a radially compressed state (optionally in a delivery sheath) by a delivery device and positioned between the leaflets 38. When positioned, the prosthetic valve can be deployed from the delivery sheath and radially expanded against the leaflets to a radially expanded state by actuating one or more mechanical actuators of the delivery apparatus.

In some embodiments, a first member (e.g., a suture, wire, filament, or other structure) is tethered to a first portion of the leaflet and a second member (e.g., a suture, wire, filament, or other structure) is tethered to a second portion of the leaflet. The second portion of the leaflet can be near the free end of the leaflet and the first portion of the leaflet can be near the base or anchor portion of the leaflet (e.g., the distal-most portion of the leaflet). The first and second members can be tethered to the respective first and second portions by one or more anchors or pleats. By pulling the first and second members toward each other, the second portion of the leaflet is pulled toward the first portion of the leaflet, thereby folding the portion of the leaflet between the first and second portions. Upon achieving sufficient folding of the leaflets (e.g., a reduction in size and/or a position that will not occlude the coronary ostia when the prosthetic heart valve is installed within the existing valve structure), the positions of the first and second members relative to each other can be locked to maintain the folded configuration of the leaflets, and a new prosthetic heart valve can then be installed.

Fig. 5A-5H illustrate an exemplary method for folding and/or capturing leaflets using a tethered suture. As shown in fig. 5A, the delivery catheter 502 can be advanced from the ascending aorta 20 toward one of the leaflets 38 of an existing valve structure (e.g., a native aortic valve in the illustrated example or a previously installed prosthetic heart valve in the non-illustrated example). For example, the delivery catheter 502 can be positioned with its end facing the first portion of one of the leaflets 38. The first portion can be closer to the annulus 18 than the free ends 42 of the leaflets 38, and preferably distal to the ostium of the coronary artery 22. In some embodiments, the first portion of the leaflets 38 can be circumferentially aligned with the ostia of the coronary arteries 22 (e.g., aligned or substantially aligned along the same radial vector extending from the center of the existing valve structure when viewed from the ascending aorta 20).

A needle 506 having a first suture 504 attached thereto can be disposed within the delivery catheter 502. When the delivery catheter 502 is positioned adjacent the first portion of the leaflet 38, the needle 506 can be pushed out of the distal end of the delivery catheter 502 to pierce the first portion 508 of the leaflet 38. The needle 506 with the first suture 504 thus moves through the first portion 508 to the distal side of the leaflet 38, as shown in fig. 5B. At the first portion 508, at least one anchor can be formed to tether the first suture 504 to the leaflet 38. For example, the distal anchor 510 can be formed at the first portion 508. Alternatively or additionally, a proximal anchor 512 can be formed at the first portion 508. As shown in fig. 5C, the first suture 504 can extend between a distal anchor 510 and a proximal anchor 512.

For example, each anchor 510, 512 can include a knotted portion of the first suture 504, a piece of cloth or fabric, a fold formed by the leaflets, and/or a locking member. To form the distal anchor, an anchoring member (e.g., fabric, clip, etc.) can be passed over the punctured portion of the leaflet with the suture and can be expanded on the distal side. To form the proximal-side anchors, the anchor components can be delivered to the proximal side surface of the leaflet, for example, by sliding down the suture from the delivery catheter. For example, each anchor 510, 512 can comprise one or more of the suture fasteners or suture clips disclosed in U.S. patent application publication nos. 2018/0177503 and 2020/0000458, all of which are incorporated herein by reference. Further details of suture attachment to leaflets can be found in U.S. patent application publication No. 2015/0230919, which is also incorporated herein by reference.

As shown in fig. 5D, another delivery catheter 520 can be advanced from the ascending aorta 20 and positioned with its distal end facing a second portion of the same leaflet 38. The second portion can be closer to the free end 42 of the leaflet 38 than the first portion 508. In some embodiments, the second portion of the leaflets 38 can also be circumferentially aligned with the ostia of the coronary arteries 22 (e.g., aligned or substantially aligned along the same radial vector extending from the center of the existing valve structure when viewed from the ascending aorta 20). Another needle 516 having a second suture 514 attached thereto can be disposed within the delivery catheter 520. When the delivery catheter 520 is disposed adjacent the second portion of the leaflet 38, the needle 516 can be pushed out of the distal end of the delivery catheter 520 to pierce the second portion 518 of the leaflet 38. The needle 516 with the second suture 514 is thus moved through the second portion 518 to the distal side of the leaflet 38, as shown in fig. 5E.

At the second portion 518, at least one anchor can be formed to tether the second suture 514 to the leaflet 38. For example, the distal anchor 522 can be formed at the second portion 518. Alternatively or additionally, a proximal anchor 524 can be formed at the second portion 518. As shown in fig. 5F, the second suture 514 can extend between the distal anchor 522 and the proximal anchor 524. Similar to the anchors 510, 512, each anchor 522, 524 can be a knotted portion of the first suture 504, a fold formed by the leaflets, and/or a locking member, and/or can employ one or more of a suture fastener or suture clip. Although the positioning of the delivery catheter 520 and the formation of the anchors 522, 524 at the second portion 518 have been described after the positioning of the delivery catheter 502 and the formation of the anchors 510, 512 at the first portion 508, such description is for convenience only. Indeed, the steps described above with respect to fig. 5A-5F may occur simultaneously or in a different order than that described.

When the sutures 504, 514 are tethered to the first and second portions 508, 518 of the leaflet 38 by their respective anchors, the delivery catheters 502, 520 can be retracted and the coupling member 530 can be provided, as shown in fig. 5G, the coupling member 530 can be delivered, for example, via another catheter inserted through the ascending aorta over the sutures 504, 514. The coupling member 530 can have one or more through-holes, conduits, or recesses through which the sutures 504, 514 extend. For example, the coupling member 530 can be a sliding member having a pair of through holes 532, 534. The first suture 504 can extend through the first through hole 532 and the second suture 514 can extend through the second through hole 534. The lateral distance between the through holes 532, 534 can be less than the distance between the first and second portions 508, 518 along the contour of the leaflet 38. Thus, when the coupling member 530 is advanced distally from the ascending aorta 20 toward the leaflets 38, the spacing between the through holes 532, 534 pulls the first and second portions 508, 518 of the leaflets 38 toward each other, thereby causing the leaflets 38 to fold. Specifically, the portion 538 of the leaflet between the anchored portion 526 (e.g., closest to the annulus 18) and the anchored portion 528 (e.g., closest to the free end 42) can be folded over on itself to have a pleated configuration between the anchor 510/512 and the anchor 522/524, or at least extend distally away from the coronary artery 22, as shown in fig. 5H. Alternatively, the coupling member can be a sliding member having a single through hole. Both the first and second sutures 504, 514 can extend through the same through-hole. The distal end of the through-hole can have a transverse dimension (e.g., diameter) that is less than the distance between the first portion 508 and the second portion 518 along the contour of the leaflet 38. Thus, when the coupling member is advanced toward the leaflet 38, the sidewalls of the through-hole pull the first and second portions 508, 518 of the leaflet 38 toward each other, thereby causing the leaflet 38 to fold.

In some embodiments, the delivery catheter 502 used to tether the first suture 504 to the first portion 508 of the leaflet 38 can be the same delivery catheter used to tether the second suture 514 to the second portion 518. For example, after forming the anchors 510, 512 at the first portion 508, the suture 504 can be cut at a location between the distal end of the delivery catheter 502 and the anchor 512, and the severed portion of the suture 504 is retained for subsequent use with a coupling member. For example, due to the delivery catheter 520 in fig. 5F, the delivery catheter 502 is thus prevented from being repositioned relative to the second portion 518. Optionally, after forming the anchors 510, 512 at the first portion 508, the first suture 504 is maintained extending from the end of the delivery catheter 502 during repositioning relative to the second portion 518. The second needle 516 and the second suture 514 can be extended from the delivery catheter 502 while the first suture 504 continues to extend between the first portion 508 and the catheter 502. In such a configuration, the delivery catheter 502 may be used as a "single-pass" coupling member to pull the first and second portions 508, 518 together after the anchors 522, 524 are formed.

When the coupling member 530 is in contact with the proximal anchors 512, 524 and/or when the leaflets have otherwise achieved sufficient folding (the folded leaflets 38 are positioned distal to the ostia of the coronary arteries 22, even when squeezed radially outward as a result of subsequent installation of the prosthetic heart valve within the existing valve structure), the coupling member 530 can be locked in position relative to the anchored portions 526, 528, as shown in fig. 5H. The locking of the coupling member 530 can ensure that the folded portions of the leaflets 38 do not unfold during or after installation of the prosthetic heart valve. For example, the coupling member 530 can be locked in place by a separate physical device 536 that is in contact with the proximal side of the coupling member 530. Alternatively or additionally, the coupling member 530 may be configured to be reconfigured between a sliding configuration (e.g., where the through-holes 532, 534 allow relative movement between the sutures 504, 514 and the coupling member 530) and a non-sliding configuration (e.g., where the through-holes 532, 534 limit relative movement between the sutures 504, 514 and the coupling member 530, e.g., by pressing the sutures 504, 514 into contact with the sidewalls of the respective through-holes). Alternatively or additionally, the coupling member 530 can be locked in place by manipulation of the suture itself. For example, the free ends of the sutures 504, 514 extending from the proximal side of the coupling member 530 can be joined together (e.g., by binding, gluing, fusing, or closing) to lock the coupling member in place.

With the coupling member 530 locked in place, each suture 504, 514 can be cut (e.g., at a location proximate to the locking device 536 or at another location proximal to the location of the coupling member) and proximally retracted, as shown in fig. 5H. The cutting of each suture 504, 514 can be performed by a cutting tool provided from the distal end of either delivery catheter 502, 520 or via a separate catheter in the ascending aorta 20. Optionally, portions of one or both of the delivery catheters 502, 520 (e.g., the distal ends of the catheters 502, 520) can include cutting elements for cutting the respective sutures 504, 514.

The anchored portions 526, 528, which are pulled toward each other, thus capture and fold the leaflet portion 538 and position the leaflet distally of the coronary artery 22 from the end 42, thereby preventing or at least reducing the risk of occluding the ostium of the coronary artery 22. If additional capture/folding of one or more leaflets 38 of the existing valve structure is desired, e.g., to prevent or at least reduce the risk of occlusion of the ostium of coronary artery 24, the technique of fig. 5A-5H can be repeated in a similar manner with the same delivery catheter 502, 520 or a different delivery catheter with respect to the next leaflet 38. In such repetition, the portions of the next leaflet 38 that are punctured by the needles 506 and 516, respectively, can be circumferentially aligned with the ostium of the coronary artery 24 (e.g., aligned or substantially aligned along the same radial vector extending from the center of the existing valve structure when viewed from the ascending aorta 20). Although not discussed in detail above, the manipulation of the needles 506, 516 and/or sutures 504, 514 within the anatomy of the patient, the formation or installation of the anchors 510, 512, 522, 524, and/or the coupling member 530 or locking device 536 movement may be performed using any tool employed in laparoscopic and/or transcatheter heart surgery, such as, but not limited to, a suture cutter, manipulator, etc.

When no additional leaflets are desired to be captured/folded, the new prosthetic heart valve in a crimped state can then be advanced to an existing valve structure (such as that shown in fig. 4G) having captured leaflets 38. The new valve is disposed within the valve structure and expanded such that the captured leaflets 38 are disposed on the outer surface of the new valve frame. However, the proximal anchored portions 526, 528 hold the leaflets 38 in a position distal to the coronary arteries 22, 24, thereby allowing blood to flow from the outflow end of the new prosthetic valve to the coronary arteries 22, 24 when the heart valve implantation is complete.

In some embodiments, a locking device can be used to capture the leaflets in the folded configuration and at a location that avoids occlusion of the corresponding coronary ostia. The locking device can be advanced over the free end of the leaflet in the open configuration. When the locking device is further advanced over the leaflet, a portion of the locking device or an actuator thereof can collect a portion of the leaflet between opposing members of the locking device. When a sufficient portion of the leaflets has been collected (e.g., a reduction in size and/or a location that would not otherwise occlude the coronary ostia when the prosthetic heart valve is installed within the existing valve structure), the locking device can be transitioned to a closed configuration in which the locking device members are brought closer to each other to contact and retain the collected portions of the leaflets therebetween, and a new prosthetic heart valve can then be installed.

6A-6B illustrate an exemplary locking device, and FIGS. 6C-6E illustrate an exemplary method for folding and/or capturing leaflets using the exemplary locking device. Specifically, fig. 6A illustrates the locking device 600 in an open configuration, and fig. 6B illustrates the locking device 600 in a closed configuration. The locking device 600 can have a first member 602 and a second member 614. In the open configuration, the first member 602 is spaced apart from the second member 614 to define a gap 620 therebetween. In the closed configuration, the first member 602 and the second member 614 are proximate to each other to eliminate or at least reduce the size of the gap 620. The first member 602 can be configured as a female member, for example, having one or more recesses 604. The second member 614 can be configured as a male member, such as one or more protrusions or tines 616. Each protrusion 616 corresponds to one of the recesses 604, wherein the protrusion 616 is spaced apart from the corresponding recess 604 and aligned with the corresponding recess 604 in the open configuration, and the protrusion 616 is inserted into a portion of the corresponding recess 604 and in contact with the corresponding recess 604 in the closed configuration. Each protrusion 616 can have a sharp tip configured to pierce a leaflet within the gap 620 when the locking device 600 transitions from the open configuration to the closed configuration.

The protrusion 616 and the recess 604 can be configured with one or more snap-fit features, for example, to prevent removal of the protrusion 616 from the recess 604 when the protrusion 616 is inserted into the recess 604 in a closed configuration. For example, the protrusion 616 may include a barbed portion 618, and the recess 604 may include a ridge 606 therein. When the locking device 600 is transitioned to the closed configuration, the tab 616 is inserted into the recess 604 such that the edges of the barbed portion 618 abut the ridge 606 to resist withdrawal of the tab 616 from the recess 604. In some embodiments, the projections 616 include a plurality of barbed portions, for example, to accommodate variations in the thickness of the collected portion of the leaflet between the first and second members 602, 614. In addition to or instead of the snap-fit locking feature between the recess 604 and the projection 616, the locking device 600 can include one or more external locking features, such as, but not limited to, linear ratchet teeth disposed on the outer portions of the members 602, 614 adjacent the gap 620, for example. In such an alternative configuration, a linear ratchet can be used as the collection member, as described further below.

Although only one protrusion 616 and one recess 604 are shown in fig. 6A-6B, embodiments of the disclosed subject matter are not so limited. More specifically, the second member 614 can have a plurality of individual protrusions 616, and the first member 602 can have a plurality of corresponding recesses 604. Further, although each member 602, 614 is illustrated as having only one of the protrusion 616 or the recess 604, in some embodiments, the members 602, 614 may include both. For example, the second member 614 can have one or more recesses in addition to the protrusion 616, and the first member 602 can have one or more protrusions in addition to the recess 604. In embodiments having multiple projections and recesses, one, some, or all of the projection-recess pairs can include snap-fit features.

The transition of the locking device 600 from the open configuration to the closed configuration can be achieved by an actuator. For example, the actuator can be a scissor-type actuator 612, such as the actuator shown in fig. 6A. The actuator 612 can have a first arm 610 attached to the coupling 608 of the first member 602 and a second arm 624 attached to the coupling 622 of the second member 614. The first and second arms 610, 624 can be coupled together at a hinge 626, which allows the arms 610, 624 to rotate relative to each other. The application of a compressive force at the ends 628, 630 (which forces the ends together) causes the arms 610, 624 to pivot about the hinge 626 and thereby force the first and second members 602, 614 toward each other. The actuator arms 610, 624 can be releasably attached to the respective coupling portions 608, 622 such that the actuator 612 can be removed from the locking device 600 after it is placed in a closed configuration (e.g., as illustrated in fig. 6B). Other types of actuators are also possible, according to one or more contemplated embodiments. Indeed, any actuator that is capable of operating within the ascending aorta of a patient and controllably moving the first and second members 602, 614 toward each other while maintaining alignment between the recess 604 and the protrusion 616 can be used.

In some embodiments, the actuator 612 defines a region 632 adjacent to the gap 620, the region 632 being designed to collect a portion of the leaflet into the gap 620 as the locking device 600 is moved from the free end of the leaflet toward the annulus. For example, the region 632 can be formed by the portion of the arms 610, 624 at the hinge 626 that faces the gap 620. Alternatively or additionally, a separate structure (e.g., a collection member) can be disposed between the actuator 612 and the gap 620 and can be used to collect the leaflets. For example, the collection member may comprise a suture, wire, or filament extending between the coupling portions 608, 622 in the region 632. In another example, the collection member may be a rod extending between the actuator arms 610, 624 in the region 632, the rod having a slot that allows unrestricted movement of the actuator arms 610, 624 relative to each other.

As shown in fig. 6C, the locking device with actuator 612 can be advanced from the ascending aorta 20 in an open configuration to be positioned relative to one of the leaflets 38 of an existing valve structure (e.g., a native aortic valve in the illustrated example or a previously installed prosthetic heart valve in the not illustrated example). For example, the free ends 42 of the leaflets 38 can be disposed within the gap 620 between the first member 602 and the second member 614. The locking device 600 with the actuator 612 can then be advanced further along the leaflet 38, as shown in fig. 6D. For example, when the locking device 600 is moved toward the annulus 18, the region 632 adjacent the hinge 626 of the actuator 612 abuts the free end 42 of the leaflet 38 and causes it to fold over on itself such that the folded portion 634 of the leaflet 38 is collected within the gap 620. Alternatively or additionally, the collection member between the gap 620 and the region 632 can contact the free end 42 of the leaflet 38 to cause the leaflet 38 to fold over on itself when the locking device 600 is advanced.

The amount of advancement of the locking device can be selected such that the proximal folded edges 636 of the leaflets 38 are positioned distal of the ostia of the coronary arteries 22 even when pressed radially outward due to subsequent installation of the prosthetic heart valve within the existing valve structure. When the locking device 600 has been sufficiently advanced over the leaflets, the actuator 612 can be actuated to transition the locking device 600 to the closed configuration, as shown in fig. 6E. The protrusion of the second member 614 thus moves toward the first member 602, thereby piercing the folded portion of the leaflet in the gap 620 before being inserted into the corresponding recess of the first member 602. Transitioning to the closed configuration can further lock the first and second members together, e.g., via one or more of the snap-fit features described above. The locking of the locking device can ensure that the captured portions 634 of the leaflets 38 do not deploy during or after installation of the prosthetic heart valve. The actuator 612 can thus be released from the locking device 600, and can then be used to install the locking device on another leaflet or otherwise be retrieved from the patient.

The installation of the locking device 600 thus folds the portion of the leaflet 38 and captures it distal to the coronary artery 22, thereby preventing or at least reducing the risk of obstructing the ostium of the coronary artery 22. If additional capture/folding of one or more leaflets 38 of an existing valve structure is desired, for example, to prevent or at least reduce the risk of occlusion of the ostia of the coronary arteries 24, the technique of fig. 6C-6E can be repeated in a similar manner with respect to the next leaflet 38 using another locking device and the same actuator 612 or a different actuator. Although not discussed in detail above, manipulation of the locking device 600 and/or the actuator 612 within the patient's anatomy, actuation of the actuator 612, and/or detachment of the actuator 612 may be performed using any tool employed in laparoscopic and/or transcatheter cardiac surgery.

When no additional leaflets are desired to be captured, the new prosthetic heart valve in a crimped state can then be advanced to an existing valve structure (such as that shown in fig. 4G) having leaflets 38 captured by locking device 600. The new valve is disposed within the valve structure and expanded such that the captured leaflets 38 are disposed on the outer surface of the new valve frame. However, the locking device 600 holds the captured leaflets 38 in a position distal to the coronary arteries 22, 24, thereby allowing blood to flow from the outflow end of the new prosthetic valve to the coronary arteries 22, 24 when the heart valve implantation is complete.

In some embodiments, a clip member can be used to capture the leaflets in the folded configuration and at a location that avoids occluding the corresponding coronary ostia. The clamp member can have a biased state and a free state. In the biased state, the ends of the clamp member may be retained at opposite ends of the clamp member (e.g., having a substantially linear configuration). In the free state, the ends of the clamp members are brought towards each other such that the clamp members at least partially define a capture area. The clamp member can be urged over the free end of the leaflet in a biased condition. One end of the clamp member can be disposed on a distal side of the leaflet. The clamp member can then be released from the biased state, thereby transitioning to the free state and capturing a portion of the leaflet within the capture region. A new prosthetic heart valve can then be installed.

Fig. 7A illustrates an exemplary clamp member in a free state, and fig. 7B-7D illustrate an exemplary method for folding and/or capturing leaflets using the exemplary clamp member. The clamp member 700 can have ends 706, 708 connected together by a middle portion 702. In the free state illustrated in fig. 7A, the clamp member 700 has a teardrop or Ω shape. The intermediate portion 702 assumes a curved configuration that defines a capture area 704 for receiving a leaflet therein. The ends 706, 708 can be in contact with each other or spaced apart from each other by a gap, which can be sized smaller than the thickness of the leaflet. The clamp member 700 can be provided in a biased state for loading into the delivery catheter and for initial positioning around a portion of the leaflet. In the biased state illustrated in fig. 7B, the end portions 706, 708 of the clamp member 700 are pulled apart such that the first end 706 is on a side of the middle member 702 opposite a side of the second end 708. In the biased state, the clamp member 700 can assume a substantially linear or arcuate configuration (e.g., arcuate).

The clamp member 700 can be formed of a flexible material (e.g., spring steel) or a shape memory alloy that automatically transitions from the biased state to the self-contained state upon release of the force holding the ends 706, 708 apart (e.g., when released from the delivery catheter). For example, the clamp member can be formed from steel, cobalt-chromium alloy, or nickel-titanium alloy (e.g., nitinol). In some embodiments, the clamp member 700 can include a coating on one, some, or all portions thereof. For example, at least a portion of the clamp member 700 can have a biocompatible surface coating. Alternatively or additionally, the ends 706, 708 can be provided with a surface coating or surface treatment that improves retention of the leaflet when installed. For example, a surface coating or surface treatment may increase the coefficient of friction of the ends 706, 708 compared to the native state of the base material.

In some embodiments, the cross-sectional geometry of the clamp members from end 706 to end 708 is substantially the same. For example, the clamp member 700 can be formed from a flexible rod of substantially constant diameter that is formed into a suitably curved shape for the free state. In other embodiments, at least the end portions 706, 708 have a different shape and/or are formed from a different material than the material of the intermediate portion 702. For example, the ends 706, 708 can be sized or shaped to help retain the leaflets therebetween. In the illustrated example of fig. 7A, the end portions 706, 708 are shaped as balls having a diameter greater than the thickness of the middle portion 702. The ball ends 706, 708 can be used to clamp the leaflets therebetween when the clamp member 700 is transitioned to the free state. Alternatively or additionally, the ends 706, 708 can be formed of a magnetic material. When disposed over the leaflets in a free state, the ends 706, 708 can attract one another with the leaflets therebetween, which can improve retention of the leaflets by the clip member 700. In another example, the ends 706, 708 and/or the portions of the clamp member 700 leading to the ends 706, 708 can be formed as extended flat areas that contact the leaflet when disposed on the leaflet in a free state. The extended flat area can increase the contact surface area, thereby improving the retention of the leaflet by the clamp member 700. Other shapes and configurations for end portions 706, 708 and/or intermediate portion 702 are possible in accordance with one or more embodiments of the disclosed subject matter.

As shown in fig. 7B, the clamp member 700 can be disposed within a lumen of a delivery catheter 710. The sidewalls of the lumen of the delivery catheter 710 can contact the end portions 706, 708 and/or the intermediate portion 702 to apply a biasing force that maintains the clamp member 700 in a biased state. The delivery catheter 710 can be advanced from the ascending aorta 20 to be positioned relative to one of the leaflets 38 of an existing valve structure (e.g., a native aortic valve in the illustrated example or a previously installed prosthetic heart valve in the non-illustrated example). For example, the distal end 714 of the delivery catheter 710 can be disposed within the central gap between the leaflets and adjacent to the free ends 42 of the leaflets 38, as illustrated in fig. 7B. The first end 706 can extend from a distal end 714 of the delivery catheter 710 and contact a distal side portion 716 of the leaflet 38, as illustrated in fig. 7C. At the same time, the sidewalls of the lumen of the delivery catheter 710 can continue to exert a biasing force between the end 708 and the intermediate portion 702 to maintain the biased state configuration. Positioning of the delivery catheter 710 relative to the leaflet 38 (as shown in fig. 7B) can occur simultaneously with, before, or after extension of the first end 706 from the end 714 of the delivery catheter.

The clamp member 700 can continue to be advanced from the end 714 of the delivery catheter 710 with the first end 706 contacting the distal side of the leaflet 38 until the second end 708 is released from the lumen of the delivery catheter 710. With the lumen no longer applying a biasing force, the clamp member 700 is allowed to transition from the biased state to the free state, with the ends 706, 708 proximate to one another, as shown in fig. 7D. The second end 708 is thus crimped distally toward the annulus 18 and is disposed on a proximal side of the leaflet 38 at a location opposite the first end 706. When the clamp member 700 is transitioned to the free state, the intermediate portion 702 contacts a proximal portion of the leaflet 38 (e.g., a portion adjacent the free end 42), thereby causing the proximal portion to fold over itself and be captured within the capture region 704. The clamp member 700 can be constructed such that the ends 706, 708 in the free state will contact each other or be separated by a gap less than the thickness of the leaflet 38. Thus, when the clamp member 700 is disposed over the leaflet 38 in a free state, the portion of the leaflet 38 between the ends 706, 708 is clamped by the ends 706, 708 to hold the clamp member 700 in place. The dimensions of the clamp member 700 and/or its positioning can be selected so that the leaflets 38 are positioned distal of the ostia of the coronary arteries 22 even when squeezed radially outward as a result of subsequent installation of the prosthetic heart valve within the existing valve structure.

In some embodiments, deployment of the clamp member 700 from the delivery catheter 710 can be accomplished using the deployment member 712. The deployment member 712 may be a flexible rod that can be actuated to move axially within the delivery catheter 710. For example, the deployment member 712 can be moved distally within the lumen of the delivery catheter 710 to contact the second end 708 and push the clamp member 700 from the distal end 714 of the catheter 710. In another example, the clamp member 700 can be deployed by maintaining the position of the deployment member 712 relative to the existing valve structure as the catheter 710 is proximally retracted. In yet another example, the clamp member 700 can be deployed by a combination of movement of the catheter 710 (e.g., proximally retracted) and movement of the deployment member 712 (e.g., distally moved within the lumen of the delivery catheter).

The installation of the clamp member 700 thus folds the portion of the leaflet 38 and captures it distal to the coronary artery 22, thereby preventing or at least reducing the risk of occluding the ostium of the coronary artery 22. If additional capture/folding of one or more leaflets 38 of an existing valve structure is desired, for example, to prevent or at least reduce the risk of occlusion of the ostia of the coronary arteries 24, the technique of fig. 7B-7D can be repeated in a similar manner with another clamp member with respect to the next leaflet 38. The same delivery catheter 710 and/or deployment member 712 can be used to deploy another clamp member on the next leaflet 38. For example, two or more clamp members 700 in a biased state can be serially disposed within the lumen of the same delivery catheter 710. A deployment member 712 in contact with the second end of the proximal clamp member can push the series of clamp members 700 together to sequentially deploy each clamp member from the end of the catheter 710.

When no additional leaflets are desired to be captured, the new prosthetic heart valve in a crimped state can then be advanced to an existing valve structure (such as that shown in fig. 4G) having leaflets 38 captured by the clamp member 700. The new valve is disposed within the valve structure and expanded such that the captured leaflets 38 are disposed on the outer surface of the new valve frame. However, the clip member 700 holds the captured leaflets 38 in a position distal to the coronary arteries 22, 24, thereby allowing blood to flow from the outflow end of the new prosthetic valve to the coronary arteries 22, 24 when the heart valve implantation is complete.

In some embodiments, the clip member can be plastically deformed to capture the leaflets in the folded configuration and at a location that avoids occluding the corresponding coronary ostia. The clamp member can have first and second ends connected together by an intermediate portion. In the open configuration of the clamp member, the first and second ends can be separated from each other by a gap. In the closed configuration of the clamp members, this gap can be reduced or eliminated. The clamp member can be positioned in the open configuration such that the free end of the leaflet extends through the gap. The clamp member is movable toward a distal portion (e.g., tip portion) of the leaflet to cause folding of the leaflet. The actuator can then be used to apply a compressive force to the clamp members that causes the clamp members to plastically deform (e.g., bend) to the closed configuration. At least the folded portion of the leaflet is capable of being captured within an area surrounded by the clamp member in the closed configuration. A new prosthetic heart valve can then be installed.

For example, fig. 10A illustrates the clamp member 1000 in an initial configuration, fig. 10B illustrates the clamp member 1000 in an open configuration, and fig. 10C illustrates the clamp member 1000 in a closed configuration. The clamp member 1000 can have a first end 1002a and a second end 1002b connected together by an intermediate portion 1002. In the initial configuration illustrated in fig. 10A, the clamp member 1000 has a substantially linear shape with first and second ends on opposite ends of the middle portion 1002 relative to its longitudinal axis. Such a configuration may, for example, facilitate delivery of clip member 1000 to an implantation site via a delivery catheter or sheath.

Upon delivery to the implantation location, the clamp member 1000 can be plastically deformed to the open configuration of fig. 10B, e.g., by bending the middle portion 1002 such that the ends 1002a, 1002B face each other across the gap 1016 (e.g., to have a substantially C-shape). The clamp member 1000 in the open configuration thus defines a partially enclosed or capture area 1004. Alternatively, in some embodiments, the clamp member 1000 may be initially formed in the open configuration of fig. 10B, e.g., by casting, molding, or otherwise forming the middle portion 1002 to have a C-shape without bending from the linear configuration of fig. 10A.

To transition the clamp member 1000 to the closed configuration of fig. 10C, the clamp member 1000 is disposed in a region 1014 between a first arm 1010 and a second arm 1012 of the actuator. The actuator applies a compressive force that plastically deforms the clamp member such that the gap 1016 between the first and second ends is eliminated or at least reduced (e.g., less than the thickness of the leaflet), thereby further surrounding the capture region 1004 to capture a portion of the leaflet therein. The actuator can be, for example, forceps, surgical forceps, or a scissor-type actuator (e.g., similar to actuator 612 illustrated in fig. 6A). However, other actuators are possible in accordance with one or more contemplated embodiments. In fact, the actuator can be any type of actuator that operates within the ascending aorta of a patient and applies a compressive force to the clamp member. For example, the arms 1010, 1012 can be coupled to opposite ends of the clamp member 1000, and the sheath can be advanced over the arms from their proximal ends toward their distal ends, thereby forcing the arms together to apply a compressive force to the clamp member.

The clamp member 1000 can be formed of a material having sufficient rigidity to maintain its shape after being plastically deformed. For example, the clamp member 1000 can comprise a metal, a metal alloy, or any combination thereof, such as steel or a cobalt chromium alloy. In some embodiments, the clamp member 1000 can include a coating on one, some, or all portions thereof. For example, at least a portion of the clamp member 1000 can have a biocompatible surface coating. Alternatively or additionally, the ends 1002a, 1002b (e.g., the tip 1006 and/or the tip 1008) can be provided with a surface coating or surface treatment that improves retention of the leaflet when installed. For example, a surface coating or surface treatment may increase the coefficient of friction of the tips 1006, 1008 as compared to the native state of the base material.

In some embodiments, the cross-sectional geometry of at least the intermediate portion between the ends 1002a, 1002b is substantially the same. For example, the clamp member 1000 can be formed from a substantially constant diameter rod that is plastically deformed from the linear configuration of fig. 10A to the open configuration of fig. 10B. In some embodiments, at least the end portions 1002a, 1002b can have a different shape and/or be formed from a different material than the material of the middle portion 1002. For example, the ends 1002a, 1002b can be sized or shaped to help retain the leaflets therebetween. In the illustrated example of fig. 10A-10C, the first end 1002a has a first tip 1006 and the second end 1002b has a second tip 1008. Each tip 1006, 1008 can taper or at least narrow in diameter end in a direction away from the intermediate portion 1002 so as to be able to pierce through the leaflet when in contact therewith. Optionally, in some embodiments, the tips 1006, 1008 can be replaced with a ball end (similar to the ball end illustrated in fig. 7A) for clamping the leaflets therebetween when the clamp member 1000 is in the closed configuration. Alternatively or additionally, the tips 1006, 1008 and/or the ends 1002a, 1002b can be formed from a magnetic material. When disposed over the leaflets in the open configuration, the magnetic material can attract one another with the leaflets therebetween, which can improve retention of the leaflets by the clip member 1000. Additional shapes and configurations for the end portions 1002a, 1002b and/or the middle portion 1002 are also possible in accordance with one or more embodiments of the disclosed subject matter.

As shown in fig. 11A, the actuator arms 1010, 1012 can be used to advance the clamp member in an open configuration from the ascending aorta 20 so as to be positioned relative to one of the leaflets 38a of an existing valve structure (e.g., a native aortic valve in the illustrated example or a previously installed prosthetic heart valve in an example not illustrated). For example, the free end 1018 of the leaflet 38a can be arranged to extend through the gap 1016 between the first tip 1006 and the second tip 1008 into the capture region 1004, as shown in fig. 11B. The actuator arms 1010, 1012 can then be used to further advance the clamp member along the leaflet 38a, as shown in fig. 11C. For example, when the clamp member is moved toward a distal portion of the leaflet 38a (e.g., a root or tip region of the leaflet or an annulus of the valve structure), the middle portion 1002 of the clamp member abuts the free end 1018 of the leaflet 38a and causes it to fold over itself such that the folded portion of the leaflet 38a is collected within the gap 1016.

The amount of clip member advancement can be selected such that the folded leaflets 38a are positioned distal to the ostium of the coronary artery 22 even when pressed radially outward due to subsequent installation of the prosthetic heart valve within the existing valve structure. When the clamp member has been sufficiently advanced over the leaflets, the actuator can be actuated to apply a compressive force between the arms 1010, 1012, thereby plastically deforming the clamp member into a closed configuration, as shown in fig. 11D. The tips 1006, 1008 of the clamp members thus move toward each other and pierce a portion of the leaflet 38a or at least clamp a portion of the leaflet 38a therebetween. Plastic deformation of the clamp member can be effective to lock the tips 1006, 1008 in place relative to the leaflet 38 a. The actuator can then be released from the clip member, and can then be used to mount the clip member on another leaflet or otherwise be retrieved from the patient. After removal of the actuator, the clamp member remains on the folded leaflet 38a when in place, as shown in fig. 11E. Plastic deformation of the clip member can thus ensure that the portion of the leaflet 38a captured within the region 1004 does not deploy during or after installation of the prosthetic heart valve.

It should be understood that only a portion of the actuator arms 1010, 1012 are shown in fig. 11A-11D for clarity of illustration. However, in an actual embodiment, the actuator will include additional portions not shown, such as a hinge section (e.g., for a scissor-type actuator), a joint section (e.g., for forceps or surgical forceps), and/or a delivery catheter or sheath (e.g., for a sheath that is advanced over the arms to provide a force that forces the arms together). In addition, one or more delivery catheters or sheaths can be provided to deliver the clamp member and actuator to the ascending aorta, and/or for operation of the actuator within the ascending aorta.

The mounting of the clamp member thus folds the portion of the leaflet 38a and captures it distal to the coronary artery 22, thereby preventing or at least reducing the risk of occluding the ostium of the coronary artery 22. If additional capture/folding of one or more leaflets 38 of the existing valve structure is desired, e.g., to prevent or at least reduce the risk of occlusion of the ostium of coronary artery 24, the technique of fig. 11A-11E can be repeated in a similar manner with respect to the next leaflet 38 using another clamp member and the same actuator (e.g., arms 1010, 1012) or a different actuator. Although not discussed in detail above, manipulation of the clamp member 1000 and/or actuators within the anatomy of a patient, actuation of actuators that plastically deform the clamp member 1000, and/or separation of the actuators from the clamp member 1000 may be performed using any tool employed in laparoscopic and/or transcatheter heart surgery.

When no additional leaflets are desired to be captured, the new prosthetic heart valve in a crimped state can then be advanced to the existing valve structure with leaflets 38 captured by clip member 1000. The new valve is disposed within the valve structure and expanded such that the captured leaflets 38 are disposed on the outer surface of the new valve frame. However, the clip member holds the captured leaflets 38 in a position distal to the coronary arteries 22, 24, thereby allowing blood to flow from the outflow end of the new prosthetic valve to the coronary arteries 22, 24 when the heart valve implantation is complete.

In some embodiments, the tool can be used to temporarily fold the leaflet under the coronary ostium and hold it in place until the prosthetic heart valve can be positioned within the existing valve structure and expanded at least partially therein. As the prosthetic heart valve expands, the folded leaflets are pushed toward and into contact with the surrounding anatomy (e.g., the aortic wall) or pre-existing structure (e.g., the valve frame wall of a previously implanted prosthetic valve) by the valve frame wall. The portion of the tool coupled to the leaflet can be pushed away from the prosthetic heart valve prior to its full expansion (e.g., prior to the size of the annular region between the valve frame and the surrounding structure will prevent removal of the tool). Since the leaflets have been positioned distally and folded, the risk of occluding the coronary ostia during valve expansion can be reduced.

For example, fig. 8A illustrates an exemplary leaflet folding tool 800 that can be used to temporarily fold leaflets of an existing valve structure. The tool 800 includes a delivery catheter or sheath 802 having a distal end configured to be disposed within the ascending aorta of a patient. The sheath 802 can comprise at least two members-a positioning member 804 and a leaflet-engaging member 808. Each of the members 804, 808 can be independently manipulated within the sheath 802 and extend from the sheath 802, such as by manipulation by an operator via a handle (not shown) at a proximal region of the sheath 802. In the illustrated embodiment, the sheath 802 is in the form of a shaft, but in other embodiments, the sheath can include multiple shafts that can be disposed adjacent to one another within the same sheath.

Each of the members 804, 808 can be extended from the distal end of the sheath 802 to interact with existing valve structures. For example, as shown in fig. 9A-9F, the positioning member 804 can be configured for insertion into a pocket or sinus 906 between the leaflets 38 and the frame 12 (or aortic wall 30 when treating the native valve) of an existing valve structure in order to guide placement and positioning of the leaflet-engaging members 808 relative to the leaflets 38. Each of the members 804, 808 can be a pre-formed wire or cable, for example, a wire formed from a shape memory material such as nitinol. Thus, when the members 804, 808 are pushed out of the distal end of the sheath, the end portions thereof can assume their predetermined shape. Alternatively, the positioning member 804 and/or the leaflet-engaging member 808 can be formed from other materials, such as metals (e.g., steel, titanium, etc.), metal alloys (e.g., cobalt-chromium alloys, etc.), plastics, or any combination thereof.

In some embodiments, at least the distal-most end portion 806 of the positioning member 804 is configured to be atraumatic (e.g., blunt or otherwise free of sharp edges) to avoid trauma to surrounding anatomy during operation. For example, the positioning member 804 can have a contoured end portion 806, the contoured end portion 806 having a circular shape, an oval shape (e.g., spoon-shaped), an elliptical shape, a C-shape, a J-shape, or any other arcuate shape, such that the contact area before the end portion 806 and the base (e.g., tip portion) of the leaflet can be increased. In some embodiments, the positioning member 804 can be formed from a plurality of wires, e.g., a pair of wires that are bent laterally to meet to contact or attach to each other at the end portion 806. Optionally, in some embodiments, the positioning member comprises a catheter or sheath having an atraumatic distal end.

The leaflet-engaging member 808 can include a pointed tip 810 at its axial end that is configured to penetrate or otherwise pinch the leaflet. In some embodiments, the pointed tip 810 includes only points or spikes, e.g., as in the member 808a illustrated in the detailed view of fig. 8B. The sharp point can be used to pierce a portion of the leaflet to engage it. In other embodiments, the tip can have a barbed configuration that prevents, or at least impedes, further insertion of the tip through the leaflet so as to help push the leaflet distally. For example, in the detailed views of fig. 8C-8D, leaflet-engaging member 808b has an inverted-barbed configuration with a laterally extending base 812 spaced proximally from the barbed tip 810 along the axial direction of member 808 b. Alternatively, the barb configuration can comprise an annular base (e.g., a radially extending base) rather than a laterally extending base 812.

Fig. 9A-9C illustrate various stages for distally positioning leaflets 38 of an existing valve structure using a leaflet folding tool 800 to avoid coronary occlusion due to subsequent implantation of a prosthetic heart valve. The delivery shaft 802 can be advanced from the ascending aorta 20 to the existing valve structure. The positioning member 804 and the leaflet-engaging member 808 can be retained within the shaft 802 prior to reaching the existing valve structure. When the shaft 802 reaches the existing valve structure (e.g., the distal end 814 is positioned near the coronary artery 22), the positioning member 804 can be advanced from the distal end 814 of the shaft 802 toward the base 906 of the leaflet 38 (e.g., the base of the leaflet's cusp), but spaced apart from the base 906 of the leaflet 38 (e.g., the base of the leaflet's cusp). Concurrently with or sequentially with (e.g., before or after) the advancement of the positioning member 804, the leaflet-engaging member 808 can be advanced from the distal end 814 of the shaft toward the proximal portion 904 of the leaflet 38, as shown in fig. 9A.

The leaflet-engaging member 808 can be pushed into contact with the leaflet portion 904 such that the pointed tip 810 passes therethrough (e.g., from its proximal side to its distal side), as shown in fig. 9B. The transverse base portion 812 is brought into contact with the proximal side of the leaflet portion 904 to limit further insertion of the spiked tip 810. The transverse base 812 also increases the surface contact area to help push the leaflets distally. Specifically, the leaflet-engaging member 808 and the positioning member 804 can be advanced together (e.g., by moving the delivery shaft 802 distally, by simultaneously advancing the members 804, 808 distally off the shaft 802, or by any combination thereof) such that the engaging member 808 pushes the free end 908 of the leaflet away from the plane 902 of the coronary ostium, effectively folding the leaflet, as shown in fig. 9C. The advancement of the two members 804, 808 can continue until the positioning member 804 reaches the base portion 906 of the leaflet 38. With the leaflets 38 held in this folded position, the prosthetic heart valve can then be implanted, whereby the folded leaflets 38 reduce the risk of occluding the ostia of the coronary arteries 22 after valve implantation.

In some embodiments, at least two of the leaflets of an existing valve structure can be subjected to folding, for example, using respective leaflet folding tools. For example, a leaflet folding tool can be provided for each leaflet (e.g., three folding tools for three leaflets). If folding of additional leaflets of the existing valve structure is desired, e.g., to prevent or at least reduce the risk of occlusion of the ostium of coronary artery 24, the technique of fig. 9A-9C can be repeated in a similar manner with respect to the next leaflet 38 using a separate folding tool 820, e.g., as shown in fig. 9D. In such repetition, the portion 904 of each leaflet 38 folded by the respective tool 800, 820 can be circumferentially aligned with the ostium of the coronary artery 22 or the coronary artery 24 (e.g., aligned or substantially aligned along the same radial vector extending from the center of the existing valve structure when viewed from the ascending aorta 20).

When no additional leaflets are desired to be folded, the new prosthetic heart valve in a crimped state can then be advanced to the existing valve structure with the captured leaflets 38. For example, as depicted in fig. 9E, a new prosthetic valve 10 (which can be the valve 10 of fig. 2A or a different prosthetic valve) can be positioned in a region 910 between the free ends of the leaflets 38, as shown in fig. 9E. The new prosthetic valve 10 is then partially expanded such that the folded leaflets 38 are positioned in an annular region 912 between the outer circumferential surface of the new valve frame and the surrounding structure (e.g., aortic wall), as shown in fig. 9F. Prior to safe expansion of the valve 10, the leaflet-engaging members 808 can be removed from the respective leaflets 38 (e.g., by proximally retracting the leaflet-engaging members), and the members 804, 808 removed from the annular region 912, thereby allowing the valve 10 to fully expand toward the aortic wall 30. Upon separation from the leaflets 38, the leaflet-folding tools 800, 820 can be removed from the ascending aorta, for example, by retracting the members 804, 808 within the respective sheaths 802 and removing from the patient's vasculature. The folded leaflets are thus laterally compressed against the aortic wall 30 by the fully expanded frame of the prosthetic heart valve 10 at a location distal to the plane 902 of the coronary ostia, thereby reducing the risk of occluding the coronary arteries 22, 24 and allowing blood to flow from the outflow end of the new prosthetic valve to the coronary arteries 22, 24 when the heart valve implantation is complete.

In any of the examples mentioned above, any of the delivery catheter or sheath, locking device, folding tool, and/or clamp member can be provided to the existing valve structure from the ascending aorta via any transcatheter aortic access approach (such as, but not limited to, transfemoral, transaxillary, transatlcular, transapical, transcarotid, transseptal, transvenal, subclavian, radial, or carotid approaches).

In any of the above-mentioned examples, any of the delivery catheter or sheath, locking device, folding tool, and/or clip member can be used to capture/fold the native valve structure of another one of the native heart valves (e.g., lung, tricuspid valve, or mitral valve) or leaflets of a prosthetic heart valve previously implanted therein. It should be noted that any device or technique described herein in connection with folding or otherwise altering the position of the native leaflets to avoid or minimize obstruction of the coronary ostia can be applied to one or more leaflets of a previously implanted prosthetic heart valve prior to or while implanting a new prosthetic heart valve in a valve-in-valve procedure in the previously implanted prosthetic heart valve. In addition, any of the delivery catheter or sheath, locking device, folding tool, and/or clamp member can thus be configured to be delivered to the heart via other blood vessels. For example, to access the tricuspid valve or lung location, a delivery catheter or sheath, a locking device, a folding tool, and/or a clamp member can be delivered via the inferior and superior vena cava. To access the mitral valve location, a delivery catheter or sheath, a locking device, a folding tool, and/or a clamp member can be delivered via a transseptal procedure, for example, by advancing through the inferior or superior vena cava and through the atrial septum. Optionally, to access the mitral valve location, a delivery catheter or sheath, a locking device, a folding tool, and/or a clamp member can be delivered via a transapical approach, e.g., by advancing through the wall of the left ventricle at the base of the heart.

In any of the above-mentioned examples, the capturing/folding of leaflets in an existing valve structure can be performed on the existing valve structure before or after a balloon annuloplasty procedure as part of the balloon annuloplasty procedure, e.g., to prepare an existing heart valve (e.g., a native aortic valve or a previously implanted prosthetic valve) for subsequent implantation of a new prosthetic valve. Optionally, in any of the examples mentioned above, the capturing/folding of leaflets in an existing valve structure can be performed as part of or prior to a Transcatheter Aortic Valve Implantation (TAVI) or Transcatheter Aortic Valve Replacement (TAVR) procedure, e.g., to replace a native aortic valve or to replace a failed prosthetic valve (e.g., a ViV procedure). Indeed, while the example of fig. 3A-11E specifically illustrates the capture/folding of leaflets in a native aortic valve, it should be readily understood that the same techniques can be applied to a previously implanted prosthetic heart valve, e.g., prior to installation of the new prosthetic heart valve within the previously implanted heart valve or simultaneously with the new prosthetic heart valve within the previously implanted heart valve. Accordingly, embodiments of the disclosed subject matter are not limited to the specific illustrations.

Where not otherwise explicitly stated above, the components can be formed of any type of biocompatible material of sufficient strength or flexibility for use in a particular application. Such materials can include, but are not limited to, metals or metal alloys such as surgical steel, titanium, cobalt chromium alloys, and nickel titanium alloys (nitinol), and polymers such as polyurethane, polytetrafluoroethylene, and polyethersulfone.

Additional examples of the disclosed technology

In view of the above-described embodiments of the disclosed subject matter, the present application discloses additional examples that are listed below. It should be noted that more than one feature of an example, taken alone or in combination and optionally in combination with one or more features of one or more other examples, is also other examples within the disclosure of this application.

Example 1. a method, comprising:

providing a crimped prosthetic heart valve in an ascending aorta of a patient, the prosthetic heart valve having an expandable frame supporting a first valve structure therein and a leaflet capturing member disposed along an exterior of the expandable frame and coupled to the expandable frame at opposite ends thereof, the leaflet capturing member extending along an axial direction of the frame and including a distal portion, a proximal portion, and a middle portion between and coupled to the distal and proximal portions by respective connecting portions,

positioning the crimped prosthetic heart valve within an existing second valve structure such that free ends of leaflets of the second valve structure contact the leaflet capturing members on the exterior of the expandable frame, the second valve structure being between the ascending aorta and a left ventricle of the heart; and

expanding the expandable frame of the prosthetic heart valve to mount the prosthetic heart valve within the second valve structure, the expanding deforming the shape of the leaflet capturing member to capture the free ends of the leaflets between the intermediate portion and the distal portion,

wherein the captured free ends of the leaflets allow blood to flow through a frame of the prosthetic heart valve to coronary arteries of the heart that would otherwise be blocked by the leaflets of the second valve structure.

Example 2. the method of any example herein (specifically example 1), wherein a plurality of the leaflet capturing members are at different locations of a circumference of the expandable frame, and the expanding is such that a free end of each leaflet of the existing second valve structure is simultaneously captured by a respective one of the leaflet capturing members.

Example 3. the method of any example herein (particularly any one of examples 1-2), wherein prior to expanding the expandable frame, each leaflet capturing member comprises a substantially straight rod extending along the axial direction.

The method of any example herein (particularly any one of examples 1-3), wherein at least the proximal portion of each leaflet capturing member has an open cell structure that allows blood to flow therethrough.

Example 5. the method according to any of the examples herein (in particular any of examples 1-4), wherein at least one of the connecting portions comprises a region having a narrowed cross-section compared to the distal portion, the proximal portion, and/or the intermediate portion.

Example 6. the method of any example herein (specifically any one of examples 1-5), wherein at least one of the connection portions comprises a weakened, notched, or fluted portion or a region having a narrowed cross-section.

Example 7. the method of any example herein (specifically any one of examples 1-6), wherein:

prior to the expanding, a first connection portion coupling the proximal portion to the intermediate portion is disposed proximal to a second connection portion coupling the distal portion to the intermediate portion; and

after the expanding, the first connection portion is disposed distal to the second connection portion.

The method of any example herein (particularly any of examples 1-7), wherein the existing second valve structure is a native aortic valve of the heart.

Example 9. the method of any example herein (specifically any of examples 1-7), wherein the existing second valve structure is a second prosthetic valve previously implanted in the patient, and the expanding is such that the prosthetic heart valve is installed within the second prosthetic valve.

Example 10a prosthetic heart valve, comprising:

a ring frame expandable from a crimped state to a deployed state;

a first valve structure formed from a leaflet assembly comprising a plurality of leaflets, the first valve structure disposed within and attached to the annular frame; and

a leaflet capturing member disposed along an exterior of the annular frame and coupled at opposite ends thereof to the annular frame, the leaflet capturing member extending along an axial direction of the annular frame, the leaflet capturing member including a distal portion, a proximal portion, and an intermediate portion between and coupled to the distal and proximal portions by respective connecting portions,

wherein the leaflet capturing member is configured to change shape after the annular frame is expanded to the deployed state so as to capture free ends of leaflets of the existing second valve structure between the intermediate portion and the distal portion.

Example 11 the prosthetic heart valve of any example herein (specifically example 10), further comprising additional leaflet capturing members disposed at different locations of a circumference of the annular frame.

Example 12 the prosthetic heart valve of any example herein (specifically any of examples 10-11), wherein each leaflet capturing member comprises a substantially straight rod extending along the axial direction prior to expansion of the annular frame.

The prosthetic heart valve of any example herein (specifically any of examples 10-12), wherein at least the proximal portion of each leaflet capturing member has an open cell structure that allows blood to flow therethrough.

Example 14 the prosthetic heart valve of any example herein (specifically any of examples 10-13), wherein at least one of the connection portions comprises a weakened area.

Example 15 the prosthetic heart valve of any example herein (specifically any of examples 10-14), wherein at least one of the connection portions comprises a region having a narrowed cross-section compared to the distal portion, the proximal portion, and/or the intermediate portion.

Example 16 the prosthetic heart valve of any example herein (specifically any of examples 10-15), wherein at least one of the connection portions comprises a notched or fluted region.

The prosthetic heart valve of any example herein (specifically any of examples 10-16), wherein the leaflet capturing member is formed of a metal or a biocompatible polymer.

The prosthetic heart valve of any example herein (specifically any of examples 10-17), wherein the leaflet capturing member is configured such that:

prior to expansion of the ring frame, a first connection portion coupling the proximal portion to the middle portion is disposed proximal to a second connection portion coupling the distal portion to the middle portion; and

after expansion of the ring frame, the first connection portion is disposed distal to the second connection portion.

Example 19. a method, comprising:

(a) passing a first portion of a suture through a first portion of a leaflet of an existing valve structure so as to extend from a proximal side of the leaflet facing a patient's ascending aorta to a distal side of the leaflet facing a left ventricle of the patient's heart;

(b) after (a), carrying the first portion of the suture back to the ascending aorta via a central gap between free ends of the leaflets of the valve structure;

(c) after (b), forming a knot by binding the first portion of the suture to a second portion of the suture disposed proximal to the first portion of the leaflet such that the portion of the leaflet between the first portion of the leaflet and the leaflet free end is disposed within a loop formed between the bound first and second suture portions; and

(d) sliding at least one of the knot and the suture relative to the other to reduce the size of the annulus, thereby compressing the leaflet portion by moving the leaflet free end toward the first portion of the leaflet.

Example 20. the method of any example herein (specifically example 19), wherein the compressing in (d) causes the leaflet portion within the annulus to fold over itself.

Example 21 the method of any example herein (specifically any one of examples 19-20), further comprising repeating (a) - (d) with respect to another leaflet of the valve structure.

Example 22. the method of any example herein (specifically any one of examples 19-21), further comprising:

after (d), installing a prosthetic heart valve within the existing valve structure,

wherein the compressed leaflet portion allows blood to flow through a frame of the prosthetic heart valve to coronary arteries of the heart that would otherwise be blocked by the leaflets of the existing valve structure.

Example 23. the method of any example herein (specifically any one of examples 19-22), wherein (a) comprises piercing the first leaflet portion with a needle coupled to the first suture portion.

Example 24. the method of any example herein (specifically example 23), further comprising:

prior to (a), providing a delivery catheter in the ascending aorta, and

positioning the delivery catheter with its end adjacent the first leaflet portion,

wherein (a) comprises extending the needle with the attached first suture portion from the delivery catheter end to pierce the first leaflet portion.

Example 25. the method of any example herein (specifically example 24), further comprising:

after (a) and before (c), withdrawing the delivery catheter back into the ascending aorta to expose the second suture portion.

The method of any example herein (specifically any one of examples 19-25), wherein (d) comprises moving a sliding member distally along the suture to push the knot toward the first leaflet portion.

Example 27. the method of any example herein (specifically example 26), wherein the sliding member comprises a portion of the delivery catheter.

Example 28. the method of any example herein (particularly example 26), wherein the sliding member is extended from an end of the delivery catheter.

Example 29. the method of any example herein (specifically any one of examples 19-25), wherein (d) comprises using a positioning member to abut a proximal end of the knot when proximally retracting the suture.

Example 30. the method of any example herein (specifically any one of examples 26-29), further comprising, after (d), locking a position of the knot relative to the first leaflet portion using the sliding member or the positioning member.

Example 31. the method of any example herein (specifically any one of examples 19-30), further comprising, after (d), locking a position of the knot relative to the first leaflet portion.

Example 32. the method of any example herein (specifically example 31), wherein the locking comprises:

placing a separate locking member in contact with the knot;

tensioning the knot such that the knot cannot slide along the suture;

bonding, fusing or closing the knot; or

Any combination of the above.

Example 33. the method of any example herein (particularly any of examples 19-32), wherein the first leaflet portion is distal to a coronary ostium of the heart.

Example 34 the method of any example herein (particularly any of examples 19-33), wherein the first leaflet portion is closer to a distal attachment portion of the leaflet than a center of the existing valve structure.

Example 35 the method of any example herein (particularly any of examples 19-34), wherein the existing valve structure is a native aortic valve of the heart.

Example 36. the method of any example herein (specifically any of examples 19-34), wherein the existing valve structure is a second prosthetic heart valve previously implanted in the patient, and installing the prosthetic heart valve includes installing the prosthetic heart valve within the second prosthetic heart valve.

Example 37. a method, comprising:

(a) forming one or more first anchors for a first suture at a first portion of a leaflet of an existing valve structure extending proximally from the one or more first anchors at the first leaflet portion, the existing valve structure being between an ascending aorta and a left ventricle of a heart;

(b) forming one or more second anchors for a second suture at a second portion of the leaflet, the second suture extending proximally from the one or more second anchors at the second leaflet portion, the second leaflet portion being closer to the free end of the leaflet than the first leaflet portion, one of the first and second leaflet portions being closer to the free end of the leaflet than the other of the first and second leaflet portions; and

(c) pulling one of the first and second leaflet sections toward the other of the first and second leaflet sections to compress the portion of the leaflet disposed between the first and second anchors.

Example 38. the method of any example herein (particularly example 37), wherein:

the one or more first anchors being a pair of first anchors, one of the first anchors being formed on a distal side of the leaflet, the other of the first anchors being formed on a proximal side of the leaflet,

the one or more second anchors are a pair of second anchors, one of the second anchors being formed on a distal side of the leaflet, the other of the second anchors being formed on a proximal side of the leaflet,

the distal side faces the left ventricle, an

The proximal side faces the ascending aorta.

Example 39. the method of any example herein (particularly any one of examples 37-38), wherein (c) comprises sliding a coupling member distally along the first and second sutures from the ascending aorta toward the leaflets.

Example 40. the method of any example herein (particularly example 39), wherein:

the coupling member has a first conduit through which the first suture extends and a second conduit through which the second suture extends, and

the spacing between the first and second conduits is less than the distance along the leaflet between the first leaflet portion and the second leaflet portion.

Example 41. the method of any example herein (particularly example 39), wherein:

the coupling member has a single conduit through which the first and second sutures extend, and

the conduit has a dimension less than a distance along the leaflet between the first and second leaflet sections.

Example 42. the method of any example herein (specifically any one of examples 39-41), further comprising, after (c), locking a position of the coupling member relative to the first and second anchors.

Example 43 the method of any example herein (specifically any one of examples 37-42), wherein one or more of the formed first and second anchors comprises a suture clip or fastener.

Example 44. the method of any example herein (specifically any one of examples 37-43), wherein one or more of the formed first and second anchors comprise one or more folds of the leaflet.

Example 45 the method of any example herein (particularly example 44), wherein each pleat includes a locking member that maintains a position of the pleat relative to the corresponding first or second leaflet portion.

Example 46. the method of any example herein (specifically any one of examples 37-45), wherein (a) comprises:

positioning a first delivery catheter with an end of the first delivery catheter adjacent a proximal side of the first leaflet section;

piercing the first leaflet portion with a needle coupled to the first suture by extending the needle from the end of the first delivery catheter;

forming one of the first anchors on a distal side of the first leaflet portion; and

forming another one of the first anchors on the distal side of the first leaflet section.

Example 47. the method of any example herein (specifically example 46), wherein (a) further comprises, after the piercing, proximally retracting the first delivery catheter toward the ascending aorta.

Example 48. the method of any example herein (specifically any one of examples 46-47), wherein (b) comprises:

repositioning a first delivery catheter with an end of the first delivery catheter adjacent a proximal side of the second leaflet portion;

piercing the second leaflet portion with another needle coupled to the second suture by extending the other needle from the end of the second delivery catheter;

forming one of the second anchors on a distal side of the second leaflet section; and

forming another one of the second anchors on the proximal side of the second leaflet section.

Example 49. the method of any example herein (particularly example 48), wherein (b) further comprises, after the piercing, proximally retracting the first delivery catheter toward the ascending aorta.

Example 50. the method of any example herein (specifically any one of examples 46-47), wherein (b) comprises:

positioning a second delivery catheter with an end of the second delivery catheter adjacent a proximal side of the second leaflet section, the second delivery catheter being a different catheter than the first delivery catheter;

piercing the second leaflet portion with another needle coupled to the second suture by extending the other needle from the end of the second delivery catheter;

forming one of the second anchors on a distal side of the second leaflet section; and

forming another one of the second anchors on the proximal side of the second leaflet section.

Example 51. the method of any example herein (specifically example 50), wherein (b) further comprises, after the piercing, proximally retracting the second delivery catheter toward the ascending aorta.

Example 52. the method of any example herein (specifically any one of examples 46-51), wherein (c) comprises using the first delivery catheter as the coupling member that slides over the first and second sutures to force the first and second leaflet portions together.

Example 53. the method of any example herein (specifically any one of examples 37-52), wherein the compressing in (c) causes the leaflet portion between the first and second anchors to fold over itself.

Example 54. the method of any example herein (specifically any one of examples 37-53), further comprising repeating (a) - (c) with respect to another leaflet of the existing valve structure.

Example 55. the method of any example herein (specifically any one of examples 37-54), further comprising:

after (c), installing a prosthetic heart valve within the existing valve structure,

wherein the compressed leaflet portion allows blood to flow through a frame of the prosthetic heart valve to coronary arteries of the heart that would otherwise be blocked by the leaflets of the existing valve structure.

Example 56 the method of any example herein (particularly any one of examples 37-55), wherein the one of the first and second leaflet portions is distal to a coronary ostium of the heart.

Example 57 the method of any example herein (specifically any one of examples 37-56), wherein the one of the first and second leaflet portions is closer to a distal attachment portion of the leaflet than a center of the existing valve structure.

Example 58. the method of any example herein (particularly any one of examples 37-57), wherein the existing valve structure is a native aortic valve of the heart.

Example 59. the method of any example herein (specifically any of examples 37-57), wherein the existing valve structure is a second prosthetic heart valve previously implanted in a patient, and installing the prosthetic heart valve comprises installing the prosthetic heart valve within the second prosthetic heart valve.

Example 60. a system for leaflet capture, the system comprising:

a locking device comprising first and second members and having an open configuration in which the first and second members are spaced from each other by a gap, and a closed configuration in which the gap is reduced or eliminated,

wherein, in the open configuration, the gap between the first and second members is configured to receive a portion of a leaflet therein, and

the closed configuration causes the leaflet portion to be captured between the first and second members.

Example 61. the system of any example herein (particularly example 60), wherein:

the first member having one or more protruding portions and the second member having one or more recesses, each recess corresponding to one of the protruding portions,

in the open configuration, each protruding portion is separated from the corresponding recess, and

in the closed configuration, each protruding portion is inserted into the corresponding recess.

Example 62. the system of any example herein (specifically example 61), wherein each protruding portion is configured to pierce the leaflet portion within the gap when the locking device transitions from the open configuration to the closed configuration.

Example 63. the system of any example herein (in particular any of examples 60-62), wherein:

the first member having a protruding portion with one or more barb portions,

the second member having a recess with one or more ridges therein,

in the open configuration, the protruding portion is separated from the recessed portion, and

in the closed configuration, the projection is inserted into the recess such that at least one of the barb portions abuts at least one of the ridges so as to resist removal of the projection from the recess.

Example 64 the system of any example herein (particularly any one of examples 60-63), further comprising an actuator configured to displace the first and second members from the open configuration to the closed configuration.

Example 65. the system of any example herein (particularly example 64), wherein the actuator is releasably coupled to the locking device so as to be separated therefrom when the locking device is in the closed configuration.

Example 66. the system of any example herein (particularly any of examples 64-65), wherein the actuator comprises a collection portion disposed adjacent to the gap in the open configuration and configured to collect a portion of the leaflet into the gap when the locking device is advanced over the free end of the leaflet.

Example 67. the system of any example herein (particularly any one of examples 64-66), wherein:

the actuator is a scissor-type actuator having a pair of arms coupled via a hinge,

one of the arms is coupled to the first member of the locking device, and

the other of the arms is coupled to the second member of the locking device.

Example 68. the system of any example herein (specifically any one of examples 60-67), further comprising:

a collection member disposed adjacent the gap and between the locking device and the actuator in the open configuration,

wherein the collection member is configured to collect a portion of the leaflet into the gap when the locking member is advanced over the free end of the leaflet.

Example 69. the system of any example herein (specifically example 68), wherein the collection member comprises a portion of at least one of the arms adjacent to the hinge.

Example 70. the system of any example herein (specifically example 68), wherein the collection member comprises a suture, wire, cable, or other flexible member extending between the first and second locking device members.

Example 71. the system of any example herein (specifically example 68), wherein the collection member is supported on one or more portions of the actuator.

Example 72 the system of any example herein (particularly any one of examples 60-71), wherein the first and second members are configured to be coupled together by a snap-fit in the closed configuration.

Example 73. a method, comprising:

(a) providing a locking device in an ascending aorta of a patient, the locking device comprising first and second members and having an open configuration and a closed configuration, the first and second members being spaced apart from each other by a gap in the open configuration, the gap being reduced or eliminated in the closed configuration;

(b) positioning the locking device in the open configuration such that free ends of leaflets of an existing valve structure are disposed within the gap between the first and second members, the existing valve structure being between the ascending aorta and a left ventricle of the patient's heart;

(c) moving the locking device in the open configuration from the free end to a distal portion of the leaflet with the leaflet disposed within the gap; and

(d) after (c), moving at least one of the first and second members of the locking device relative to the other so as to transition from the open configuration to the closed configuration, thereby capturing a portion of the leaflet between the first and second members.

Example 74. the method of any example herein (specifically example 73), wherein the moving in (c) causes the leaflet to fold over itself, and the captured portion in (d) comprises a folded portion of the leaflet.

Example 75. the method of any example herein (particularly any one of examples 73-74), wherein, in (d), one of the first and second members of the locking device is disposed on a proximal side of the leaflet facing the ascending aorta and the other of the first and second members of the locking device is disposed on a distal side of the leaflet facing the left ventricle.

Example 76. the method of any example herein (specifically any one of examples 73-75), further comprising:

after (d), installing a prosthetic heart valve within the existing valve structure,

wherein the captured leaflet portion allows blood to flow through a frame of the prosthetic heart valve to coronary arteries of the heart that would otherwise be blocked by the leaflets of the existing valve structure.

Example 77. the method of any example herein (particularly any one of examples 73-76), wherein:

the first member having one or more protruding portions and the second member having one or more recesses, each recess corresponding to one of the protruding portions,

in (b) and (c), each protruding portion is separated from the corresponding recess portion, and

(d) such that each protruding portion is inserted into the corresponding recess.

Example 78 the method of any example herein (particularly any one of examples 73-76), wherein:

the first member having a protruding portion provided with one or more barb portions,

the second member having a recess with one or more ridges therein,

in (b) and (c), the protruding portion is separated from the recess, and

(d) such that at least one of the barb portions abuts at least one of the ridges to resist removal of the projection from the recess.

Example 79 the method of any example herein (in particular any of examples 77-78), wherein the moving in (d) causes at least one of the protruding portions to pierce the portion of the leaflet between the first and second members before or during insertion into the respective recess of the second member.

Example 80. the method of any example herein (particularly any one of examples 73-79), wherein, after (d), the first and second members are coupled together in the closed configuration by a snap-fit.

Example 81. the method of any example herein (particularly any one of examples 73-80), wherein the moving in (c) causes one or more portions of the leaflet between the free end and the distal portion to be collected into the gap by a collection member disposed proximate to the gap.

Example 82. the method of any example herein (particularly any one of examples 73-81), wherein the moving in (d) is via an actuator coupled to the locking device.

Example 83. the method of any example herein (specific example 82), wherein:

the actuator is a scissor-type actuator having a pair of arms coupled via a hinge,

one of the arms is coupled to the first member of the locking device, and

the other of the arms is coupled to the second member of the locking device.

Example 84. the method of any example herein (particularly example 83), wherein the collection member includes a portion of the actuator facing the gap.

Example 85. the method of any example herein (particularly any one of examples 83-84), wherein the collection member includes a portion of at least one of the arms adjacent to the hinge.

Example 86. the method of any example herein (particularly any one of examples 81-83), wherein the collection member comprises a suture extending between the first and second members of the locking device.

Example 87. the method of any example herein (particularly any one of examples 81-83), wherein the collection member is supported on one or more portions of the actuator.

Example 88. the method of any example herein (particularly any one of examples 82-87), further comprising, after (d), detaching the actuator from the locking device.

Example 89 the method of any example herein (particularly any one of examples 73-88), wherein the distal leaflet portion is distal to a coronary ostium of the heart.

Example 90. the method of any example herein (particularly any one of examples 73-89), wherein, after (d), the locking device is disposed closer to a distal attachment portion of the leaflet than a center of the existing valve structure.

Example 91. the method of any example herein (specifically any one of examples 73-90), further comprising:

(e) providing a second locking means in the ascending aorta;

(f) positioning the second locking device in the open configuration such that a free end of another leaflet of the existing valve structure is disposed within the gap between the first and second members;

(g) moving the second locking device in the open configuration from the free end to a distal portion of the other leaflet with the other leaflet disposed within the gap; and

(h) after (g), moving at least one of the first and second members of the second locking device relative to the other to transition from the open configuration to the closed configuration, thereby capturing a portion of the other leaflet between the first and second members.

Example 92 the method of any example herein (particularly any of examples 73-91), wherein the existing valve structure is a native aortic valve of the heart.

Example 93. the method of any example herein (particularly any of examples 73-91), wherein the existing valve structure is a second prosthetic heart valve previously implanted in the patient, and the installing the prosthetic heart valve comprises installing the prosthetic heart valve within the second prosthetic heart valve.

Example 94. a system for leaflet capture, the system comprising:

a clamp member configured to transition between a biased state and a free state, the clamp member having first and second ends connected by an intermediate portion,

wherein in the free state the intermediate portion assumes a curved configuration defining a capture area for a portion in which the leaflet is retained, and

in the biased state, the intermediate portion assumes a straight or substantially straight configuration.

Example 95. the system of any example herein (particularly example 94), wherein the free state is such that the first and second ends are disposed proximate to each other.

Example 96 the system of any example herein (particularly any one of examples 94-95), wherein the clamp member is formed of a flexible material.

Example 97 the system of any example herein (particularly example 96), wherein the clamp member is formed from a spring metal or a shape memory alloy.

Example 98. the system of any example herein (particularly example 97), wherein the clamp member is formed of steel, a cobalt-chromium alloy, or a nickel-titanium alloy.

Example 99. the system of any example herein (specifically any one of examples 94-98), wherein at least a portion of the clamp member comprises a biocompatible surface coating.

Example 100. the system of any example herein (particularly any one of examples 94-99), further comprising a delivery catheter having a lumen configured to receive the clamp member in the biased state therein, the first end of the clamp member being closer to a distal end of the delivery catheter than the second end of the clamp member.

The system of any example herein (particularly example 100), further comprising a deployment member within the delivery catheter, the deployment member configured to translate distally along an axial direction of the lumen to push the second member to deploy the clamp member from the distal end of the delivery catheter.

Example 102. the system of any example herein (particularly any one of examples 94-101), wherein in the free state, the clamp member has a substantially Ω -shape.

Example 103. the system of any example herein (particularly any one of examples 94-102), wherein in the free state, a gap between the first and second ends is less than a thickness of the leaflet.

Example 104. a method, comprising:

(a) providing a delivery catheter in an ascending aorta of a patient, the delivery catheter having a lumen in which a clamp member is disposed, the clamp member having a first end, a second end, and an intermediate portion connecting the first and second ends, the clamp member being in a biased state in which the first end is closer to a distal end of the delivery catheter than the second end;

(b) positioning the distal end of the delivery catheter relative to leaflets of an existing valve structure between the ascending aorta and a left ventricle of the patient's heart;

(c) extending at least the first end of the clamp member from the distal end of the delivery catheter; and

(d) after (c), releasing the clamp member from the delivery catheter such that the clamp member transitions to a free state to capture a portion of the leaflet,

wherein after (c) and before (d), the first end is disposed on a distal side of the leaflet, in the free state, the intermediate portion assumes a curved configuration and defines a capture zone, and

after (d), the second end is disposed on a proximal side of the leaflet and the portion of the leaflet is captured within the capture region.

Example 105. the method of any example herein (particularly example 104), wherein after (d), the first and second ends are disposed on opposite sides of and in contact with the first portion of the leaflet.

Example 106 the method of any example herein (specifically example 105), wherein after (d), the first and second ends clamp the first portion of the leaflet to hold the clamp member in place.

Example 107. the method of any example herein (in particular any one of examples 105 and 106), wherein after (d), the portion of the leaflet captured within the capture region is between the first portion of the leaflet and the free end of the leaflet.

Example 108. the method of any example herein (in particular any of examples 105 and 107), wherein:

the distance between the first end after (d) and the midpoint of the middle portion is less than the distance between the first portion of the leaflet and the free end of the leaflet before (c);

the distance between the second end after (d) and the midpoint of the middle portion is less than the distance between the first portion of the leaflet and the free end of the leaflet before (c); or

Both of them.

Example 109. the method of any example herein (in particular any one of examples 104 and 108), wherein the transition to the free state in (d) is such that the portion of the leaflet folds over itself and is retained within the capture region.

Example 110 the method of any example herein (in particular any one of examples 104 and 109), wherein the intermediate portion of the clamp member has a straight or substantially straight configuration in the biased state within the delivery catheter.

Example 111. the method of any example herein (in particular any of examples 104 and 110), wherein (b) is performed before (c).

Example 112. the method of any example herein (in particular any of examples 104 and 110), wherein (b) is performed after (c).

Example 113. the method of any example herein (in particular any of examples 104 and 110), wherein (b) and (c) are performed together.

Example 114. the method of any example herein (in particular any one of examples 104 and 113), wherein (c) comprises moving a deployment member within the lumen to push the clamp member distally along an axial direction of the lumen.

Example 115 the method of any example herein (particularly example 114), wherein, during (c), the deployment member contacts the second end of the clamp member.

Example 116. the method of any example herein (in particular any one of examples 114 and 115), wherein (d) comprises at least one of:

moving the deployment member distally to further advance the clamp member out of the distal end of the delivery catheter; and

moving the delivery catheter proximally toward the ascending aorta.

Example 117. the method of any example herein (in particular any one of examples 104 and 116), wherein the clamp member is formed of a flexible material.

Example 118. the method of any example herein (specifically any one of examples 104 and 117), wherein the clamp member is formed from a spring metal or a shape memory alloy.

Example 119. the method of any example herein (specifically any one of examples 104 and 118), wherein the clamp member is formed from steel, a cobalt-chromium alloy, or a nickel-titanium alloy.

Example 120. the method of any example herein (specifically any one of examples 104 and 119), wherein at least a portion of the clamp member comprises a biocompatible surface coating.

Example 121. the method of any example herein (in particular any one of examples 104 and 120), wherein in the free state, the clamp member has a substantially Ω -shape.

Example 122. the method of any example herein (in particular any one of examples 104 and 121), wherein a gap between the first and second ends in the free state is less than a thickness of the leaflet before (d).

Example 123. the method of any example herein (in particular any of examples 104 and 122), wherein the first portion of the leaflet is distal to a coronary ostium of the heart.

Example 124. the method of any example herein (in particular any one of examples 104 and 123), wherein after (d), the clamp member is disposed closer to a distal attachment portion of the leaflet than a center of the existing valve structure.

Example 125. the method of any example herein (in particular any of examples 104 and 124), further comprising, after (d):

(e) providing a second delivery catheter in the ascending aorta, the second delivery catheter having a second lumen in which a further clamp member is disposed, the further clamp member being in the biased state with its first end closer to a distal end of the second delivery catheter than the second end;

(f) positioning the distal end of the second delivery catheter relative to another leaflet of the existing valve structure;

(g) extending at least the first end of the other clamp member from the distal end of the second delivery catheter; and

(h) after (g), releasing the other clamp member from the second delivery catheter such that the other clamp member transitions to its free state so as to capture a portion of the other leaflet,

wherein after (g) and before (h), the first end of the other clamp member is disposed on a distal side of the other leaflet,

in the free state, the intermediate portion of the other clamp member assumes a curved configuration and defines another capture area, an

After (h), the second end of the other clamp member is disposed on a proximal side of the other leaflet, and the portion of the other leaflet is captured within the capture region.

Example 126. the method of any example herein (in particular any of examples 104 and 124), further comprising, after (d):

(e) repositioning the distal end of the delivery catheter relative to another leaflet of the existing valve structure;

(f) extending at least a first end of another clamp member from the distal end of the delivery catheter; and

(g) after (f), releasing the other clamp member from the delivery catheter such that the other clamp member transitions to its free state so as to capture a portion of the other leaflet,

wherein after (f) and before (g), the first end of the other clamp member is disposed on a distal side of the other leaflet,

in the free state, the intermediate portion of the other clamp member assumes a curved configuration and defines another capture area, an

After (g), the second end of the other clamp member is disposed on a proximal side of the other leaflet and the portion of the other leaflet is captured within the capture region.

Example 127 the method of any example herein (in particular any one of examples 104 and 126), wherein the existing valve structure is a native aortic valve of the heart.

Example 128. the method of any example herein (specifically any one of examples 104 and 127), further comprising, after (d):

installing a prosthetic heart valve within the existing valve structure,

wherein the captured leaflet portion allows blood to flow through a frame of the prosthetic heart valve to coronary arteries of the heart that would otherwise be blocked by the leaflets of the existing valve structure.

Example 129 the method of any example herein (specifically example 128), wherein the existing valve structure is a second prosthetic heart valve previously implanted in the patient, and the installing the prosthetic heart valve comprises installing the prosthetic heart valve within the second prosthetic heart valve.

An example 130. a system for leaflet folding, the system comprising:

a delivery sheath configured to be disposed within a vasculature of a patient and to be delivered through a vasculature of the patient;

a leaflet-engaging member disposed within the delivery sheath and axially movable therein, the leaflet-engaging member having a pointed tip at an axial end thereof; and

a positioning member disposed within the delivery sheath and axially movable therein, the positioning member having an atraumatic end portion.

Example 131. the system of any example herein (particularly example 130), wherein the delivery sheath has a lumen extending therethrough, and the leaflet-engaging member, the positioning member, or both are disposed within the lumen and axially movable therein.

Example 132. the system of any example herein (in particular any one of examples 130 and 131), wherein the positioning member comprises a wire, cable, or catheter.

Example 133 the system of any example herein (in particular any one of examples 130 and 132), wherein the atraumatic end portion of the positioning member comprises a loop.

Example 134 the system of any example herein (particularly example 133), wherein the ring comprises a circular shape, an oval shape, an elliptical shape, a C-shape, or a J-shape.

Example 135. the system of any example herein (in particular any of examples 133 and 134), wherein the loop comprises a pair of wires coupled to each other at respective ends.

Example 136. the system of any example herein (in particular any of examples 130 and 135), wherein the spiked tip is configured to pierce a portion of a leaflet in contact therewith.

Example 137. the system of any example herein (specifically any one of examples 130 and 136), wherein the barbed tip has a barbed configuration with a laterally extending or radially extending (e.g., annular) base.

Example 138. the system of any example herein (in particular any of examples 130 and 137), wherein the leaflet-engaging member comprises a wire or cable.

Example 139. the system of any example herein (in particular any one of examples 130 and 138), wherein the leaflet-engaging member is movable independently of the positioning member.

Example 140. the system of any example herein (in particular any of examples 130 and 139), further comprising:

a second delivery sheath configured to be disposed within and delivered through a vasculature of a patient concurrently with the delivery sheath;

a second leaflet-engaging member disposed within the second delivery sheath and axially movable therein, the second leaflet-engaging member having a second barbed tip at an axial end thereof; and

a second positioning member disposed within the second delivery sheath and having a second atraumatic end portion.

Example 141. a method, comprising:

(a) providing a leaflet folding tool in an ascending aorta of a patient, the leaflet folding tool comprising a leaflet-engaging member having a pointed tip at an axial end thereof and a positioning member; the positioning member having an atraumatic end portion;

(b) piercing a portion of a first leaflet of an existing valve structure using the pointed tip;

(c) moving the leaflet-engaging member and the positioning member in a direction from the ascending aorta toward the left ventricle until the non-invasive end portion of the positioning member contacts a base portion of the first leaflet such that the punctured portion of the first leaflet is pushed toward its base portion so as to fold the first leaflet;

(d) positioning a prosthetic heart valve within a space between leaflets of the existing valve structure; and

(e) expanding the prosthetic heart valve while the first leaflet remains folded.

Example 142. the method of any example herein (specifically example 141), wherein, during the expanding of (e), the leaflet-engaging member is removed from the punctured portion of the first leaflet.

Example 143. the method of any example herein (specifically example 142), wherein the first leaflet remains at least partially folded due to contact with an exterior of the prosthetic heart valve after the removing of the leaflet-engaging member.

Example 144. the method of any example herein (specifically any one of examples 141 and 143), further comprising, prior to (d):

(f) providing a second leaflet folding tool in the ascending aorta of the patient, the second leaflet folding tool comprising a second leaflet-engaging member having a second spiked tip at an axial end thereof and a second positioning member; the second positioning member has a second non-invasive end portion;

(g) piercing a portion of a second leaflet of the existing valve structure with the second barbed tip; and

(h) moving the second leaflet-engaging member and the second positioning member in the direction from the ascending aorta toward the left ventricle until the second non-invasive end portion of the second positioning member contacts a base portion of the second leaflet such that the pierced portion of the second leaflet is pushed toward its base portion so as to fold the second leaflet.

Example 145. the method of any example herein (specifically example 144), wherein during the expanding of (e), the second leaflet-engaging member is removed from the punctured portion of the second leaflet.

Example 146 the method of any example herein (specifically example 145), wherein the second leaflet remains at least partially folded due to contact with an exterior of the prosthetic heart valve after the removing of the second leaflet-engaging member.

Example 147. the method of any example herein (in particular any one of examples 141 and 146), wherein:

the leaflet folding tool further comprises a delivery sheath, the leaflet-engaging member and the positioning member each being at least partially disposed within and axially movable within the delivery sheath, and

(a) the providing of (a) includes moving the delivery sheath to the ascending aorta via a transcatheter aortic access pathway.

Example 148. the method of any example herein (specifically example 147), wherein the transcatheter aortic access pathway comprises a transfemoral approach, a transaxillary approach, a transaortical approach, a transapical approach, a transcarotid approach, a transseptal approach, a transvenal approach, a subclavian approach, a radial approach, a carotid approach, or any combination thereof.

Example 149. the method of any example herein (in particular any one of examples 147 and 148), wherein the delivery sheath has a lumen extending therethrough, and the leaflet-engaging member, the positioning member, or both are disposed within the lumen and are axially movable therein.

Example 150. the method of any example herein (specifically any one of examples 141 and 149), wherein the positioning member comprises a wire, cable, or catheter.

Example 151. the method of any example herein (in particular any one of examples 141 and 150), wherein the non-invasive end portion of the positioning member comprises a loop.

Example 152 the method of any example herein (specifically example 151), wherein the ring comprises a circular shape, an oval shape, an elliptical shape, a C-shape, or a J-shape.

Example 153 the method of any example herein (in particular any one of examples 151 and 152), wherein the ring comprises a pair of wires coupled to each other at respective proximal ends.

Example 154. the method of any example herein (specifically any one of examples 141 and 153), wherein the barbed tip has a barbed configuration with a laterally extending or annular base.

Example 155 the method of any example herein (in particular any of examples 141 and 154), wherein the leaflet-engaging member comprises a wire or cable.

Example 156 the method of any example herein (in particular any one of examples 141 and 155), wherein after (e), the folded first leaflet allows blood to flow through a frame of the prosthetic heart valve to a coronary artery of the heart that would otherwise be blocked by the first leaflet of the second valve structure.

Example 157 the method of any example herein (in particular any of examples 141 and 156), wherein the existing valve structure is a native aortic valve of the heart.

Example 158 the method of any example herein (in particular any one of examples 141 and 156), wherein the existing valve structure is a second prosthetic valve previously implanted in the patient, and the expanding the prosthetic heart valve of (e) is effective to install the prosthetic heart valve within the second prosthetic valve.

Example 159 a system for leaflet capture, the system comprising:

a clamp member configured to be plastically deformed between an open configuration and a closed configuration, the clamp member having first and second ends connected by an intermediate portion, the first and second ends being spaced apart from each other by a gap in the open configuration, the gap being reduced or eliminated in the closed configuration,

wherein, in the open configuration, the gap between the first and second ends is configured to receive a portion of a leaflet therein, and

the closed configuration causes the leaflet portion to be captured between the first and second ends.

Example 160. the system of any example herein (specifically example 159), wherein the clamp member is formed from a metal, a metal alloy, or any combination thereof.

Example 161. the system of any example herein (particularly example 160), wherein the clamp member comprises steel or a cobalt-chromium alloy.

Example 162. the system of any example herein (specifically any of examples 159 and 161), wherein at least a portion of the clamp member comprises a biocompatible surface coating.

Example 163. the system of any example herein (in particular any of examples 159 and 162), wherein the first end, the second end, or both comprises a sharp tip for piercing a leaflet, a blunt tip for gripping the leaflet without piercing, a magnetic portion, a female member for receiving a male member of the other tip, a male member for inserting into a female member of the other tip, or any combination thereof.

Example 164 the system of any example herein (in particular any of examples 159 and 163), further comprising an actuator having a first arm and a second arm, the actuator configured to apply a compressive force that plastically deforms the clamp member from the open configuration to the closed configuration.

Example 165 the system of any example herein (particularly example 164), wherein the actuator is releasably coupled to the clamp member so as to be separated therefrom when the clamp member is in the closed configuration.

Example 166. the system of any example herein (in particular any of examples 164 and 165), wherein the actuator comprises forceps, surgical forceps, or a scissor-type actuator.

Example 167. a method, comprising:

(a) providing a clamp member in an open configuration in an ascending aorta of a patient, the clamp member having first and second ends connected together by a middle portion, the first and second ends being spaced apart from each other by a gap in the open configuration;

(b) (ii) extending free ends of first leaflets of an existing valve structure between the ascending aorta and a left ventricle of the patient's heart through the gap between the first and second ends in the open configuration of the clamp member;

(c) moving the clamp member in the open configuration toward a distal portion of the first leaflet with the first leaflet extending through the gap; and

(d) after (c), plastically deforming the clamp member into a closed configuration, wherein the gap between the first and second ends is reduced or eliminated such that a portion of the first leaflet is captured within an area enclosed by the clamp member in the closed configuration.

Example 168. the method of any example herein (in particular any of examples 167), wherein the moving in (c) causes the first leaflet to fold over itself, and the captured portion in (d) comprises a folded portion of the first leaflet.

Example 169. the method of any example herein (specifically any one of examples 167 and 168), further comprising:

after (d), installing a prosthetic heart valve within the existing valve structure,

wherein the captured portion of the first leaflet allows blood to flow through a frame of the prosthetic heart valve to a coronary artery of the heart that would otherwise be blocked by the first leaflet.

Example 170. the method of any example herein (in particular any one of examples 167 and 169), wherein after (d), the first and second ends are disposed on and in contact with, or pierce through, opposite sides of the first portion of the first leaflet.

The method of any example herein (particularly example 170), wherein, after (d), the portion of the first leaflet captured by the clamp member is between the first portion of the first leaflet and the free end.

Example 172. the method of any example herein (specifically any one of examples 170 and 171), wherein:

a distance between the first end after (d) and a midpoint of the intermediate portion is less than a distance between the first portion of the first leaflet and the free end before (c);

a distance between the second end after (d) and the midpoint of the middle portion is less than a distance between the first portion of the first leaflet and the free end before (c); or

Both of them.

Example 173. the method of any example herein (in particular any one of examples 167 and 172), wherein the moving in (c) is via an actuator coupled to the clamp member.

Example 174. the method of any example herein (specifically example 173), wherein the actuator has a first arm and a second arm, and the actuator is configured to apply a compressive force that plastically deforms the clamp member into the closed configuration in (d).

Example 175 the method of any example herein (specifically example 174), further comprising, after (d), detaching the actuator from the clamp member is in the closed configuration, and removing the actuator from the ascending aorta.

Example 176. the method of any example herein (in particular any one of examples 173 and 175), wherein the actuator comprises forceps, surgical forceps, or a scissor-type actuator.

Example 177. the method of any example herein (specifically any one of examples 167 and 176), wherein the clamp member is formed from a metal, a metal alloy, or any combination thereof.

Example 178 the method of any example herein (specifically example 177), wherein the clamp member comprises steel or a cobalt-chromium alloy.

Example 179. the method of any example herein (specifically any one of examples 167 and 178), wherein at least a portion of the clamp member comprises a biocompatible surface coating.

Example 180. the method of any of the examples herein (in particular any of examples 167 and 179), wherein the first end, the second end, or both comprise a sharp tip for piercing a leaflet, a blunt tip for gripping the leaflet without piercing, a magnetic portion, a female member for receiving a male member of the other tip, a male member for inserting into a female member of the other tip, or any combination thereof.

Example 181. the method of any example herein (in particular any one of examples 173 and 180), wherein:

(a) the providing of (a) comprises moving a delivery sheath to the ascending aorta via a transcatheter aortic access pathway, and

the actuator, the clamp member, or both are disposed within the delivery sheath.

Example 182 the method of any example herein (specifically example 181), wherein the transcatheter arterial access pathway comprises a transfemoral approach, a transaxillary approach, a transaortical approach, a transapical approach, a transcervical approach, a transseptal approach, a transvenal approach, a subclavian approach, a radial approach, a carotid approach, or any combination thereof.

Example 183. the method of any example herein (in particular any one of the examples), 167-182, wherein the existing valve structure is a native aortic valve of the heart.

Example 184. the method of any example herein (in particular any of examples 167 and 182), wherein the existing valve structure is a second prosthetic valve previously implanted in the patient, and the expanding the prosthetic heart valve of (e) is effective to install the prosthetic heart valve within the second prosthetic valve.

Example 185. a method, comprising:

providing a device for leaflet capture within an ascending aorta of a patient;

expanding a prosthetic heart valve to implant the prosthetic heart valve within an existing valve structure located between the ascending aorta and the left ventricle of the patient; and

capturing, folding, compressing, or otherwise positioning one or more leaflets of the existing valve structure distal to a coronary ostium of the heart using the means for leaflet capturing prior to or during expansion of the prosthetic heart valve such that blood is allowed to flow through a frame of the prosthetic heart valve to the coronary artery after the expansion.

The method of any example herein (particularly example 185), wherein the means for leaflet capture is part of or attached to the prosthetic heart valve.

Example 187. the method of any example herein (in particular any one of examples 185 and 186), wherein the means for leaflet capturing comprises one or more leaflet capturing members, the one or more leaflet capturing members are disposed along an exterior of the prosthetic heart valve frame, and is coupled at its opposite ends to the frame, the leaflet capturing member extending along an axial direction of the frame, the leaflet capturing member comprising a distal portion, a proximal portion, and an intermediate portion between and coupled to the distal and proximal portions by respective connecting portions, the leaflet capturing member is configured to change shape after expansion of the frame for implantation, so as to capture the free ends of the leaflets of the existing valve structure between the intermediate portion and the distal portion.

Example 188. the method of any of examples (specifically examples 185 and 187) herein, wherein the means for leaflet capturing is provided to the ascending aorta via a delivery sheath or catheter.

Example 189 the method of any of examples (in particular examples 185 and 188) herein, wherein the means for leaflet capture comprises a suture passed through a first portion of a leaflet of the existing valve structure, and the using the means for leaflet capture comprises:

forming a knot by binding a first portion of the suture to a second portion of the suture such that a portion of the leaflet between the first portion of the leaflet and a free end of the leaflet is disposed within a loop formed between the bound first and second suture portions; and

sliding at least one of the knot and the suture relative to the other to reduce the size of the annulus, thereby compressing the leaflet portion by moving the leaflet free end toward the first portion of the leaflet.

Example 190. the method of any example herein (specifically example 189), wherein the sliding comprises moving a sliding member distally along the suture to push the knot toward the first leaflet portion.

Example 191 the method of any example herein (particularly example 190), wherein the sliding member comprises a portion of a delivery catheter, or the sliding member is extended from an end of the delivery catheter.

Example 192. the method of any example herein (in particular any of examples 185 and 191), wherein the means for leaflet capture comprises a first anchor for a first suture formed at a first portion of a leaflet of the existing valve structure and a second anchor for a second suture formed at a second portion of the leaflet, and the using the means for leaflet capture comprises:

pulling one of the first and second leaflet sections toward the other of the first and second leaflet sections to compress the portion of the leaflet disposed between the first and second anchors.

Example 193 the method of any example herein (particularly example 192), wherein the pulling comprises sliding a coupling member distally along the first and second sutures from the ascending aorta toward the leaflets.

The method of any example herein (specifically example 193), wherein the coupling member has one or more conduits defining a spacing between the first and second sutures extending therethrough that is less than a distance between the first and second leaflet portions along the leaflet.

Example 195 the method of any example herein (in particular any one of examples 185 and 194), wherein the device for leaflet capture comprises a locking device comprising first and second members and having an open configuration and a closed configuration, the first and second members being spaced apart from one another by a gap in the open configuration, the gap being reduced or eliminated in the closed configuration, and

the using the device for leaflet capture includes:

positioning the locking device in the open configuration such that free ends of leaflets of an existing valve structure are disposed within the gap between the first and second members, the existing valve structure being between the ascending aorta and a left ventricle of the patient's heart;

moving the locking device in the open configuration from the free end to a distal portion of the leaflet with the leaflet disposed within the gap; and

moving at least one of the first and second members of the locking device relative to the other to transition from the open configuration to the closed configuration, thereby capturing a portion of the leaflet between the first and second members.

Example 196. the method of any example herein (particularly example 195), wherein the moving the locking device in the open configuration causes the leaflet to fold over itself, and the captured portion comprises a folded portion of the leaflet.

Example 197. the method of any example herein (in particular any of examples 195-196), wherein:

the first member having a protruding portion provided with one or more barb portions,

the second member having a recess with one or more ridges therein,

said protruding portion is separated from said recess upon said positioning of said locking means and said moving of said locking means in said open configuration, and

the moving at least one of the first and second members causes the projection to be inserted into the recess such that at least one of the barb portions abuts at least one of the ridges to resist removal of the projection from the recess.

Example 198. the method of any example herein (in particular any of examples 195-197), wherein:

said moving at least one of said first and second members is via an actuator coupled to said locking device,

the actuator is a scissor-type actuator having a pair of arms coupled via a hinge,

one of the arms is coupled to the first member of the locking device, and

the other of the arms is coupled to the second member of the locking device.

Example 199 the method of any example herein (in particular any one of examples 185 and 198), wherein the means for leaflet capture comprises a clamp member configured to transition between a biased state and a free state, the clamp member having first and second ends connected by an intermediate portion, wherein in the free state the intermediate portion assumes a curved configuration defining a capture area for a portion in which a leaflet is retained, and in the biased state the intermediate portion assumes a straight or substantially straight configuration, and

the using the device for leaflet capture includes:

extending at least the first end of the clamp member in the biased state from a distal end of a delivery catheter positioned relative to leaflets of the existing valve structure; and

releasing the clamp member from the delivery catheter transitions the clamp member to the free state to capture a portion of the leaflet within the capture region.

Example 200. the method of any example herein (specifically example 199), wherein the clamp member is formed from a spring metal or a shape memory alloy.

Example 201 the method of any example herein (in particular any one of examples 185 and 200), wherein the means for leaflet capture comprises a leaflet folding tool comprising a leaflet engaging member having a pointed tip at an axial end thereof and a positioning member; the positioning member has an atraumatic end portion, and

the using the device for leaflet capture includes:

piercing a portion of a leaflet of the existing valve structure with the pointed tip; and

moving the leaflet-engaging member and the positioning member in a direction from the ascending aorta toward the left ventricle until the non-invasive end portion of the positioning member contacts a base portion of the leaflet such that the punctured portion of the leaflet is pushed toward its base portion so as to fold the leaflet.

Example 202. the method of any example herein (specifically example 201), wherein the leaflet engagement members are removed from the punctured portions of the leaflets after the prosthetic heart valve has been expanded from an initial crimped configuration but before the prosthetic heart valve has been expanded to its fully implanted size.

Example 203 the method of any example herein (in particular any one of examples 201 and 202), wherein the leaflets remain at least partially folded due to contact with an exterior of the prosthetic heart valve after the removal of the leaflet-engaging member.

Example 204. the method of any example herein (specifically any one of examples 201 and 203), wherein:

the positioning member comprises a wire, cable or conduit;

the atraumatic end portion of the positioning member comprises a loop;

the leaflet-engaging member comprises a wire or cable;

the barbed tip of the leaflet engaging member has a barbed configuration with a laterally extending or radially extending base; or

Any combination of the above.

Example 205 the method of any example herein (in particular any one of examples 185 and 204), wherein the means for leaflet capture comprises a clamp member configured to be plastically deformed between an open configuration and a closed configuration, the clamp member having first and second ends connected by an intermediate portion, the first and second ends being spaced apart from each other in the open configuration by a gap that is reduced or eliminated in the closed configuration, and

the using the device for leaflet capture includes:

(ii) extending the clamp member in the open configuration such that free ends of leaflets of the existing valve structure extend through the gap between the first and second ends;

moving the clamp member in the open configuration toward a distal portion of the leaflet with the leaflet extending through the gap; and

plastically deforming the clamp member into the closed configuration such that portions of the leaflet are captured within an area enclosed by the clamp member in the closed configuration.

Example 206 the method of any example herein (specifically example 205), wherein the moving the clamp member causes the leaflet to fold over itself, and the captured portion comprises a folded portion of the leaflet.

Example 207 the method of any example herein (in particular any one of examples 205 and 206), wherein the plastically deforming the clamp member into the closed configuration is by an actuator having first and second arms configured to apply a compressive force to the clamp member.

Example 208. the method of any example herein (in particular any one of examples 185 and 207), wherein the providing comprises moving a delivery sheath having the means for leaflet capturing therein or thereon to the ascending aorta via a transcatheter aortic access.

Example 209. the method of any example herein (in particular any of examples 185 and 207), wherein the existing valve structure is a native aortic valve of the heart.

Example 210 the method of any example herein (in particular any of examples 185 and 207), wherein the existing valve structure is a second prosthetic heart valve previously implanted in the patient, and the installing the prosthetic heart valve comprises installing the prosthetic heart valve within the second prosthetic heart valve.

Conclusion

All of the features described herein are independent of each other and can be combined with any other feature described herein except where structurally impossible. For example, the delivery system of fig. 2C or the prosthetic valve delivery described with respect to fig. 4G can be used to implant a prosthetic heart valve in any other disclosed example. In another example, aspects of the clamp member 700 described with respect to fig. 7A-7D can be applied to the plastically deformed clamp member 1000 of fig. 10A-11E, and vice versa. Indeed, any feature illustrated or described with respect to fig. 1-11E and clauses 1-210 can be combined with any other feature illustrated or described with respect to fig. 1-11E and clauses 1-210 to provide systems, methods, apparatus, and embodiments not otherwise illustrated or specifically described herein.

In view of the many possible embodiments to which the principles of the disclosed technology may be applied, it should be recognized that the illustrated embodiments are only preferred examples and should not be taken as limiting the scope of the disclosed technology. Rather, the scope is defined by the appended claims. We therefore claim all that comes within the scope and spirit of these claims.