Mechanically expandable heart valve with leaflet clip

Abstract

The invention relates to a mechanically expandable heart valve with leaflet clips. A frame for a prosthetic heart valve includes a plurality of strut members disposed to form an annular body and coupled together by a plurality of pivot joints. The body of the frame is radially collapsible to a collapsed configuration and radially expandable to an expanded configuration, and the frame has an inflow end and an outflow end. The frame further includes a plurality of leaflet clips disposed on an exterior of the body of the frame and coupled to the strut member. The plurality of leaflet clips are movable between an open position corresponding to the collapsed configuration of the frame and a closed position corresponding to the expanded configuration of the frame. Movement of the frame body between the collapsed configuration and the expanded configuration results in corresponding movement of the leaflet clip between the open position and the closed position.

Description

[0001] This application is a divisional application. The application date of the original application is April 23, 2019, the application number is 2019800388639, and the name of the invention is "Mechanically expandable heart valve with leaflet clamp". Technical Field

[0002] The present disclosure relates to implantable, mechanically expandable prosthetic devices, such as prosthetic heart valves, and to methods and delivery assemblies for such prosthetic devices. Background Art

[0003] The human heart may suffer from a variety of valvular diseases. These valvular diseases can lead to significant dysfunction of the heart and ultimately require replacement of the natural valve with an artificial valve. There are many known artificial valves and many known methods of implanting these artificial valves in humans.

[0004] Various surgical techniques are available for replacing or repairing diseased or damaged valves. Due to stenosis and other heart valve diseases, thousands of patients undergo surgery each year in which a defective natural heart valve is replaced by a prosthetic valve. Another less drastic method for treating defective valves is by repair or reconstruction, which is typically used on minimally calcified valves. The problem with surgical treatment is that it imposes a significant risk of high morbidity and mortality associated with surgical repair on chronically ill patients.

[0005] When replacing a native valve, surgical implantation of a prosthetic valve typically requires an open-chest surgery during which the heart is stopped and the patient is placed on cardiopulmonary bypass (a so-called "heart-lung machine"). In one common surgical procedure, the diseased native valve leaflets are excised and the prosthetic valve is sutured to the surrounding tissue at the valve annulus. Due to the trauma associated with the procedure and the duration of the resulting extracorporeal blood circulation, some patients do not survive the surgical procedure or die shortly thereafter. It is well known that the risk to the patient increases with the amount of time required for extracorporeal circulation. Due to these risks, many patients with defective native valves are considered inoperable because their condition is too weak to undergo the procedure. According to some estimates, more than 50% of subjects over the age of 80 with heart valve disease (such as valvular stenosis, valvular insufficiency, etc.) cannot undergo surgery for valve replacement.

[0006] Due to the disadvantages associated with traditional open heart surgery, percutaneous and minimally invasive surgical approaches have gained attention. In one technique, a prosthetic valve is configured to be implanted in a less invasive procedure by catheter insertion. For example, U.S. Patent Nos. 5,411,522 and 6,730,118, which are incorporated herein by reference, describe a collapsible transcatheter heart valve that can be introduced percutaneously in a compressed state over a catheter and expanded in a desired position by balloon inflation or using a self-expanding frame or stent.

[0007] An important design consideration is the ability of a prosthetic heart valve to remain in a treatment position after deployment without becoming dislodged. In particular, there is a need for improved devices and methods for engaging the leaflets of a native heart valve when a prosthetic heart valve is implanted. Summary of the invention

[0008] Certain embodiments of the present disclosure relate to a frame for a prosthetic heart valve, which includes a leaflet clamp. In a representative embodiment, the frame for a prosthetic heart valve includes a plurality of strut members, which are arranged to form an annular body of the frame and are coupled together by a plurality of pivot joints. The body of the frame is radially crimpable to a crimped configuration and radially expandable to an expanded configuration, and the body of the frame has an inflow end and an outflow end. The frame further includes a plurality of leaflet clamps, which are arranged on the exterior of the body of the frame and coupled to the strut members. The plurality of leaflet clamps are movable between an open position corresponding to the crimped configuration of the body of the frame and a closed position corresponding to the expanded configuration of the body of the frame. Movement of the body of the frame between the crimped configuration and the expanded configuration causes corresponding movement of the leaflet clamps between the open position and the closed position.

[0009] In some embodiments, the leaflet clamp includes a first end coupled to the body of the frame and a free second end, and when the leaflet clamp is in the open position, the free second end is spaced radially outward from the body of the frame.

[0010] In some embodiments, the free second end is disposed adjacent to the body of the frame when the leaflet clamp is in the closed position.

[0011] In some embodiments, the strut members have respective inflow ends located at the inflow end of the body of the frame, respective outflow ends located at the outflow end of the body of the frame, and respective central portions between the inflow ends and the outflow ends. When the frame is in the expanded configuration, the central portions of the strut members are radially offset inwardly from the inflow ends of the strut members and from the outflow ends of the strut members relative to the longitudinal axis of the frame, so that the body of the frame has an hourglass-shaped profile.

[0012] In some embodiments, when the frame is in the collapsed configuration, the central portions of the strut members are offset radially outward from the respective inflow and outflow ends of the strut members relative to the longitudinal axis of the frame such that the body of the frame has a barrel-shaped profile.

[0013] In some embodiments, the leaflet clamps each include a pair of strut members pivotally coupled to the strut members of the body of the frame.

[0014] In some embodiments, the strut members of the leaflet clamp each include a first end and a second end, and when the leaflet clamp is in the open position, the second ends of the strut members of the leaflet clamp are spaced radially outward from the body of the frame.

[0015] In some embodiments, the second ends of the strut members of each leaflet clamp are coupled to each other such that the leaflet clamps are V-shaped when the frame is in the expanded configuration.

[0016] In some embodiments, the first end of the strut member of the leaflet clamp is coupled to the apex of the outflow end of the body of the frame.

[0017] In some embodiments, a prosthetic heart valve includes any of the frame embodiments described herein and a leaflet structure at least partially disposed within the frame.

[0018] In another representative embodiment, a frame for a prosthetic heart valve includes a plurality of strut members arranged to form an annular body. The body of the frame is radially collapsible to a collapsed configuration and radially expandable to an expanded configuration, has an inflow end and an outflow end, and defines a longitudinal axis. The strut members of the frame have respective inflow ends located at the inflow end of the body, respective outflow ends located at the outflow end of the body, and respective center portions between the inflow ends and the outflow ends. When the frame is in an expanded configuration, the center portions of the strut members are radially offset inwardly from the inflow ends of the strut members and from the outflow ends of the strut members relative to the longitudinal axis, so that the body of the frame has an hourglass-shaped profile.

[0019] In some embodiments, when the body of the frame is in the collapsed configuration, the central portions of the strut members are offset radially outward from the respective inflow and outflow ends of the strut members relative to the frame longitudinal axis such that the body of the frame has a barrel-shaped profile.

[0020] In some embodiments, the frame further comprises a plurality of leaflet clamps disposed on an exterior of the body of the frame and coupled to the strut members.

[0021] In some embodiments, the leaflet clamp is movable between an open position corresponding to a collapsed configuration of the body of the frame and a closed position corresponding to an expanded configuration of the body of the frame.

[0022] In some embodiments, the leaflet clamps each include a pair of strut members pivotally coupled to the strut members of the body of the frame.

[0023] In some embodiments, the strut members of the leaflet clamp each include a first end and a second end, and when the leaflet clamp is in the open position, the second ends of the strut members of the leaflet clamp are spaced radially outward from the body of the frame.

[0024] In some embodiments, the second ends of the strut members of each leaflet clamp are coupled to each other such that the leaflet clamps are V-shaped when the frame is in the expanded configuration.

[0025] In some embodiments, the leaflet clamps are arcuate when the frame is in the expanded configuration.

[0026] In some embodiments, the strut members of the frame body are coupled together by a plurality of pivot joints.

[0027] In another representative embodiment, a method for implanting a prosthetic heart valve includes advancing a prosthetic heart valve in a collapsed configuration to a natural heart valve using a delivery device. The prosthetic heart valve includes a plurality of strut members coupled together by a plurality of pivot joints and arranged to form a frame having an annular body. The body of the frame is radially collapsible to a collapsed configuration and radially expandable to an expanded configuration, and includes a plurality of leaflet clamps arranged outside the body of the frame and coupled to the strut members. The leaflet clamps are movable between an open position corresponding to the collapsed configuration of the body of the frame and a closed position corresponding to the expanded configuration of the body of the frame. The method further includes positioning the prosthetic heart valve so that the leaflets of the natural heart valve are located between the respective leaflet clamps and the body of the frame; and radially expanding the prosthetic heart valve from the collapsed configuration to the expanded configuration so that the leaflet clamps move from an open position to a closed position and clamp the leaflets against the prosthetic heart valve.

[0028] In some embodiments, the leaflet clamp includes a first end coupled to the outflow end of the body of the frame and a free second end, and radially expanding the prosthetic heart valve further includes expanding the body of the frame beyond the natural diameter of the strut members such that the outflow end of the body of the frame moves radially outward from the center portion of the body of the frame and the free second end of the leaflet clamp moves adjacent to the body of the frame.

[0029] The foregoing and other objects, features and advantages of the disclosed technology will become more apparent from the following detailed description made with reference to the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] Figure 1 is a perspective view illustrating a representative embodiment of a prosthetic heart valve including a mechanically expandable frame having a plurality of leaflet clips.

[0031] Figure 2 yes Figure 1 Side elevation view of a frame of a prosthetic heart valve.

[0032] Figure 3 It is a perspective view of a representative embodiment of a support member.

[0033] Figure 4Ais a perspective view of a representative embodiment of a pivot joint.

[0034] Figure 4B yes Figure 4A A top plan view of the pivot joint.

[0035] Figure 5 is in radially collapsed configuration Figure 2 Side elevation view of the frame.

[0036] Figure 6 yes Figure 2 A side elevation view of a set of strut members of a frame, wherein the strut members are arranged in the shape of a prosthetic heart valve at the natural diameter of the strut members.

[0037] Figure 7 yes Figure 6 A top plan view of the support structure.

[0038] Figure 8 is Figure 2 When the frame is radially collapsed to a diameter less than the natural diameter of the support member, the example Figure 6 Side elevation view of the location of the strut member.

[0039] Fig. 9 is Figure 2 When the frame is radially expanded to a diameter greater than the natural diameter of the strut member, the example Figure 6 Side elevation view of the location of the strut member.

[0040] Fig.10 An example of a native aortic valve in a collapsed configuration and including a leaflet clamp in an open configuration Figure 6 A side elevation view of a support member.

[0041] Fig.11 is an example of a device in an expanded configuration such that the leaflet clamp is in a closed configuration and engages the native leaflets of the aortic valve. Figure 6 A side elevation view of a support member.

[0042] Fig.12 is a perspective view of a representative embodiment of a delivery device.

[0043] Fig.13 is a side elevation view of another embodiment of a frame at a natural diameter of the frame including an inner strut member, an outer strut member, and a leaflet clamp.

[0044] Fig.14 is in a crumpled configuration Fig.13 Side elevation view of a frame with the leaflet clamps in an open position.

[0045] Fig.15is in an expanded configuration Fig.13 Side elevation view of a frame with the leaflet clamps in a closed position.

[0046] Fig.16 is in an expanded configuration Fig.13 A side elevation view of a frame with the leaflet clamps in a closed position and bent to correspond to the curvature of the outer contour of the frame.

[0047] Fig.17 yes Fig.13 Side elevation view of a frame illustrating a cover arranged on a leaflet clamp. DETAILED DESCRIPTION

[0048] The present disclosure relates to embodiments of implantable prosthetic devices, and in particular to implantable prosthetic valves, and methods for implanting such devices. In particular embodiments, the prosthetic device includes a prosthetic heart valve, and can be configured to be implanted into any of the natural heart valves (aortic, mitral, pulmonary, and tricuspid valves). In addition, the prosthetic heart valve can be, for example, a transcatheter heart valve, a surgical heart valve, or a minimally invasive heart valve. The prosthetic valve can also include other types of valves that can be implanted in other body cavities outside the heart, or heart valves that can be implanted in locations other than natural valves within the heart, such as transatrial or transventricular septums.

[0049] The disclosed prosthetic heart valve is particularly suitable for implantation in a native aortic valve. In the case of a prosthetic aortic valve, for convenience, the terms "lower" and "upper" are used interchangeably with the terms "inflow" and "outflow", respectively. Thus, for example, in the orientation shown in the figure, the lower end of the prosthetic valve is its inflow end, and the upper end of the prosthetic valve is its outflow end. However, it should be understood that the prosthetic valve can be implanted in the opposite orientation. For example, for implantation at the mitral valve position, the upper end of the prosthetic valve is the inflow end, and the lower end of the valve is the outflow end.

[0050] In some embodiments, the prosthetic valve described herein may include a docking mechanism configured as a leaflet clamp to clamp the leaflets of the natural heart valve against the prosthetic heart valve. In some configurations, the leaflet clamp can move between an open configuration corresponding to the radially collapsed configuration of the prosthetic valve and a closed configuration corresponding to the radially expanded configuration of the prosthetic valve. In some embodiments, the diameter of the frame of the prosthetic valve can change along the longitudinal axis of the frame. The diameter of each part of the frame can also change between the collapsed configuration and the expanded configuration. For example, in some configurations, when the frame is in the collapsed configuration, the inflow end and the outflow end of the frame can be arranged radially inward of the central part of the frame, so that the frame has a convex or barrel-shaped profile. On the contrary, when the frame is in the expanded configuration, the central part of the frame can be arranged radially inward of the inflow end and the outflow end of the frame, so that the frame presents a concave or hourglass-shaped external profile. When the leaflet clamp is coupled to the frame, such radial movement of the inflow and outflow ends of the frame relative to the center portion of the frame can be used to actuate the leaflet clamp between an open position in which a leaflet receiving space is defined between the leaflet clamp and the frame, and a closed position in which the leaflet clamp is arranged against or adjacent to the frame.

[0051] For example, Figure 1 Representative embodiments of prosthetic heart valves 10 are illustrated. The prosthetic valve 10 may include a mechanically expandable stent or frame 12 having an annular body 13, and a leaflet structure 14 located within the frame and coupled to the frame 12. The frame 12 may include an inflow end 16 and an outflow end 18. The leaflet structure may include a plurality of leaflets 20 (e.g., three leaflets) configured to collapse in a tricuspid arrangement similar to the aortic valve. Alternatively, the prosthetic valve may include two leaflets 20 configured to collapse in a bicuspid arrangement similar to the mitral valve; or more than three leaflets, depending on the specific application. The prosthetic valve 10 may also include one or more sealing members to help seal the prosthetic valve against surrounding tissue after implantation. The sealing member may take the form of an annular skirt formed, for example, of a suitable fabric (e.g., PET) or natural tissue (e.g., pericardial tissue). The prosthetic valve may include an annular skirt on an inner surface of frame 12 and / or an outer surface of frame 12 .

[0052] The frame 12 may include a plurality of interconnected strut members 22 (also referred to as "first strut members"), which are arranged in a grid pattern and form a plurality of vertices 24 at the inflow end 16 and the outflow end 18 of the body 13 of the prosthetic valve. In the illustrated configuration, the frame 12 includes a first group of strut members 22A and a second group of strut members 22B. The first group of strut members 22A is located radially inward of the second group of strut members 22B, so that the strut members 22B are on the outside of the frame. In the illustrated example, the strut members 22A can be angled in a first direction and can extend helically around the longitudinal axis 78 of the frame 12, while the strut members 22B can be angled in a direction opposite to the strut members 22A and extend helically around the longitudinal axis 78 in a direction opposite to the spiral of the strut members 22A.

[0053] For example purposes, Figure 2 A representative embodiment of the frame 12 of the prosthetic valve 10 without the valve structure is illustrated, and Figure 3 A representative embodiment of the support member 22 is illustrated in more detail. Figure 3 , the strut members 22 may define a plurality of openings 28 spaced apart along the length of the strut members. For example, in the illustrated embodiment, the strut members 22A and 22B may define openings 28 at locations along their lengths where the first set of strut members 22A overlaps the second set of strut members 22B. The strut members 22 may also include openings 28 defined at their respective ends, such that the respective strut members 22A and 22B may be coupled together to form vertices 24 at the inflow and outflow ends of the frame.

[0054] like Figure 3 As shown in , each strut member 22 may have an offset, or zigzag pattern defined by a plurality of offset linear portions or segments 38. In the illustrated embodiment, the linear segments 38 are arranged end-to-end relative to each other, wherein the adjoining ends are interconnected to each other by an intermediate segment 40. The struts 22 may have an enlarged first end 41 at the inflow end of the frame and a second end 42 at the outflow end of the frame. Thus, the first end 41 and the second end 42 may form a vertex 24 at the inflow end and the outflow end of the frame. The strut member 22 may also include a center portion 76 located intermediate between the first end 41 and the second end 42.

[0055] Each linear segment 38 may be slightly laterally offset from an adjacent linear segment 38 in a direction perpendicular to the overall length of the strut 22 to provide a zigzag pattern to the strut. Each of the intermediate segment 40 and the end portions 41 and 42 may have a respective opening 28 at its geometric center for receiving a fastener 30 ( Figure 4B). The offset of each linear segment 38 relative to the adjacent linear segment along the length of the strut 22 can be constant, so that the axis 44 can pass through the hole 28 of each intermediate segment 40 along the entire length of the strut. In an alternative embodiment, the offset between two adjacent linear segments 38 can vary along the length of the strut. For example, the offset between the linear segments 38 adjacent to the outflow end of the frame can be greater than the offset between the linear segments 38 adjacent to the inflow end of the frame, and vice versa.

[0056] The linear segment 38 may include at least substantially flat or linear opposing longitudinal edges 46a, 46b that extend between the curved or rounded edges 48 of the intermediate segment 40. In an alternative embodiment, the opposing edges 48 of the intermediate segment 40 may be substantially flat or linear edges that extend at an angle between respective ends of the edges 46a, 46b of the linear segment 38.

[0057] like Figure 3 As best shown in FIG. 1 , the width W1 of each linear segment 38 is defined as the distance measured between the opposing edges 46a and 46b of the segment 38. In the illustrated embodiment, the width W1 is constant along the length of the strut 22. Thus, each longitudinal edge 46a is laterally offset from an adjacent longitudinal edge 46a of an adjacent linear segment 38, and each longitudinal edge 46b is laterally offset from an adjacent longitudinal edge 46b of an adjacent linear segment 38. The width W2 of each intermediate segment 40 and end portions 41, 42 may be greater than the width W1 of the linear segments 38.

[0058] In an optional embodiment, the width W1 of each linear segment 38 can vary along the length of the strut. For example, the width W1 of the linear segment 38 adjacent to the inflow end of the frame can be greater than the width W1 of the linear segment 38 adjacent to the outflow end of the frame, and vice versa. Further, in the case where the width W1 of the linear segment 38 varies along the length of the strut 22, the linear segment can have a longitudinal edge 46a or 46b that is colinear with the longitudinal edge of the adjacent linear segment on the same side of the strut, while the other longitudinal edge 46a, 46b is laterally offset from the longitudinal edge of the adjacent linear strut on the same side of the strut. In other words, with the help of the varying width W1 of the linear segment, the strut 22 can have an overall zigzag or offset pattern.

[0059] In an alternative embodiment, the struts 22 may have linear sections 38 that are not offset from one another; that is, the struts are substantially rectangular with the longitudinal sides of each strut extending continuously from one end of the strut to the opposite end of the strut without offset portions (e.g., similar to struts 68 described below).

[0060] return Figure 1 and Figure 2, the first set of strut members 22A of the strut members can be pivotally coupled to the second set of strut members 22B of the strut members by hinges or joints 26. In some examples, the joints 26 can be formed by inserting fasteners 30 (e.g., rivets, pins, etc.) through overlapping openings 28 of the strut members, including at the apex 24. Figure 4A and 4B A representative connector 26 is illustrated in more detail. Figure 4A , a spacer 32 (such as a washer or bushing) can be disposed in the joint between each strut member 22A and 22B. The spacer 32 can help the strut members 22A and 22B move relative to each other to expand and / or collapse the frame. The spacer 32 can also serve to space the strut members 22A, 22B from each other. In other embodiments, the joint 26 need not include a spacer 32, and / or the strut members 22 can be spaced apart in a different manner.

[0061] refer to Figure 4B In a particular embodiment, the fasteners 30 do not extend radially outward from the openings 28 in the strut members and may be completely contained within the openings. For example, each of the openings 28 on the radially outermost struts 22B may include a countersunk hole or enlarged recessed portion 34 that is sized to receive a head 36 of a respective fastener 30 (e.g., a rivet). The head 36 may be completely received within the countersunk hole 34 and not extend radially outward from the countersunk hole. For example, the head 36 may be flush with the outer surface of the strut 22B. In this way, the fasteners 30 do not increase or contribute to the overall wrinkled profile of the prosthetic valve and do not interfere with or place undue pressure on a delivery sheath that may position the valve during delivery.

[0062] Joints 26 can allow strut members 22A to pivot relative to strut members 22B when frame 12 is expanded or contracted (e.g., during assembly, manufacture, or implantation of prosthetic valve 10). For example, frame 12 (and therefore prosthetic valve 10) can be manipulated into a radially compressed or contracted configuration (see FIG. Figure 5 ) and inserted into the patient for implantation. After entering the body, the prosthetic valve 10 can be manipulated to an expanded state ( Figure 1 ) and then released from a delivery device as described below.

[0063] The frame 12 can be configured to protect soft components (e.g., leaflets 20, and any skirt, sutures, etc. that form part of the prosthetic valve) from being pinched or cut by the frame during folding and expansion of the prosthesis. Figure 5 The radially collapsed configuration is shown Figure 1The offset or zigzag pattern of the strut segments 38 can help to space the struts 22 apart in the circumferential direction when the frame 12 is in radial compression. As shown, the open lattice structure of the frame 12 defining the open cells 50 between the struts 22 can be retained even when the frame 12 is fully compressed or contracted. For example, referring to Figure 5 , although the width of the cells 50 along the length of the frame 12 can vary between adjacent struts, a gap 52 is maintained in the middle of the cells 50 between two adjacent pivot joints 26. The spaced-apart nature of the struts 22, including the gap 52, can help protect the soft components of the prosthetic valve as the frame 12 expands and contracts. When the prosthetic valve is radially compressed, the gap 52 created by the offset configuration of the struts 22 can protect the leaflets 20, skirts (such as paravalvular leakage skirts (not shown)), and / or sutures from being pinched or sheared between adjacent struts 22. In this way, the soft components of the prosthetic valve are protected from damage that may occur due to contact with the metal struts of the frame.

[0064] return Figure 1 , the frame 12 may include a plurality of rod members 54. In the exemplary configuration, the rod member 54 is configured as an actuator component, which can also be used as a release and locking unit (also referred to as a locking assembly or expansion unit) configured to radially expand and contract the frame and keep the frame in a desired expanded state. In the exemplary configuration, although the frame 12 may include three actuator components 54 coupled to the frame 12 at circumferentially spaced positions, the frame may include more or fewer actuator components depending on the specific application. Each of the actuator components 54 may generally include an internal member 56 (such as an internal tubular member), and an external member 58 (such as an external tubular member concentrically arranged around the internal member 56). As further described in U.S. Publication No. 2018 / 0153689, the internal member 56 and the external member 58 can be moved longitudinally relative to each other in a telescopic manner to expand and contract the frame 12 radially.

[0065] In an exemplary configuration, the inner member 56 may have a distal portion 60 that is coupled to the inflow end 16 of the frame 12 (e.g., via a coupling element such as a pin member). In an exemplary embodiment, each of the inner members 56 is coupled to the frame at a respective vertex 24 at the inflow end 16 of the frame. Depending on the particular application, the outer member 58 may be located, for example, at a distal portion 60 of the frame 12. Figure 1 The outer member is coupled to the apex 24 at the outflow end 18 of the frame 12 at a mid-portion of the outer member as shown in FIG. 1 , or at a proximal end of the outer member.

[0066] The inner member 56 and the outer member 58 can be telescoped relative to each other between a fully contracted state (corresponding to a fully radially expanded state of the prosthetic valve) and a fully extended state (corresponding to a fully radially compressed state of the prosthetic valve). In the fully extended state, the inner member 56 is fully extended from the outer member 58. In this way, the actuator component 54 allows the prosthetic valve to be fully expanded or partially expanded to different diameters in the patient's body and maintains the prosthetic valve in a partially or fully expanded state. As further disclosed in U.S. Publication No. 2018 / 0153689, the inner member 56 and the outer member 58 have respective locking elements that are configured to engage with each other and prevent radial compression of the frame when the frame is expanded to a desired expansion diameter and the locking element is actuated by the user.

[0067] The prosthetic valve 10 may include various other types of actuators and / or locking devices for controlling the radial expansion of the valve and / or maintaining the valve in an expanded state. For example, in some embodiments, the actuator component 54 may be a screw actuator configured to radially expand and contract the frame 12 by rotation of one of the components of the actuator. For example, the internal member 56 may be configured as a screw having an external thread engaged with the internal thread of the corresponding external component. In some embodiments, the internal friction or resistance of the screw in the screw actuator may be sufficient to maintain the frame in a desired expanded state. More details about screw actuators and various other types of actuators and locking devices that can be incorporated into the prosthetic valve are disclosed in U.S. Patent Publication No. 2018 / 0153689, U.S. Application No. 16 / 105,353 filed on August 20, 2018, and U.S. Publication No. 2014 / 0296962.

[0068] Still reference Figure 1 , the prosthetic valve 10 may include a plurality of commissure support elements configured as commissure buckles or clips 62. The adjacent sides of the leaflets are arranged in pairs, thereby forming a plurality of commissures 64 of the leaflets. In the illustrated configuration, the prosthetic valve includes a commissure clip 62 positioned at each commissure 64 and configured to clamp two adjacent sides of the leaflets 20 adjacent to the commissure at locations spaced radially inward of the frame 12.

[0069] refer to Figure 1, the prosthetic valve 10 may include a plurality of docking or retaining mechanisms configured as leaflet clamps 66. In an exemplary embodiment, the leaflet clamps 66 are disposed on a radially outward layer of the body 13 of the frame 12 and may be configured to clamp to, hold, or clamp the natural leaflets of the heart valve in which the prosthetic valve 10 is implanted so that the prosthetic heart valve is retained in the annulus after deployment. In certain embodiments, each leaflet clamp 66 may include a first end 90 coupled to the body 13 (e.g., at the outflow end 18) and a second end 92. In some embodiments, the second end 92 may be a free end that is not directly connected to the body 13 and may be movable relative to the body of the frame (e.g., movable radially inward and radially outward) when the frame expands and / or contracts.

[0070] In the illustrated embodiment, the prosthetic valve 10 includes three clamps 66, but a greater or lesser number may be used. The clamps 66 are desirably, but not necessarily, spaced equiangularly around the circumference of the frame body. When intended to be implanted in a native valve having three leaflets (e.g., an aortic valve), the prosthetic valve 10 may have three clamps 66, each of which is positioned to clamp onto one of the native leaflets. When intended to be implanted in a native valve having two leaflets (e.g., a mitral valve), the prosthetic valve 10 may have two clamps 66, each of which is positioned to clamp onto one of the native leaflets. In other embodiments, the prosthetic valve 10 may have a plurality of clamps 66, the number of which is not equal to the number of natural leaflets of the native valve in which the prosthetic valve 10 is to be implanted and / or the prosthetic valve 10 may have more than one clamp positioned to clamp onto a single natural leaflet.

[0071] In an example embodiment, each leaflet clamp 66 may include a pair of strut members 68 (also referred to as "second strut members"). The strut members 68 may include respective first ends 70, center portions 72, and second ends 74. The first ends 70 may be coupled to the body 13 of the frame 12. More specifically, in certain embodiments, the first ends 70 of the strut members 68 may be pivotally coupled to the adjacent apex 24 at the outflow end 18 of the frame (e.g., via a pivot joint 26). The second ends 74 of the strut members 68 of each clamp 66 may be pivotally coupled to each other via a pivot joint 94. In this manner, the leaflet clamps 66 may be in an expanded configuration ( Figure 1 ) and the wrinkled configuration ( Figure 5 The dashed lines in the figure indicate the movement of the

[0072] For example, when the prosthetic valve 10 is in an expanded configuration, the leaflet clamps 66 are also in an expanded configuration, and the first ends 70 of the strut members 68 are spaced apart from each other circumferentially around the frame 12, so that the strut members 68 form a V-shape. In the illustrated embodiment, the opening of the V is oriented toward the outflow end of the frame. When the prosthetic valve 10 is moved to a collapsed configuration, the leaflet clamps 66 can be moved to the collapsed configuration. For example, the first ends 70 of the strut members 68 can be pivoted about the pivot joints 26 so that when the frame 12 is radially collapsed to Figure 5 In the configuration shown in , the first end portions 70 move toward the proximal portion together. Figure 5 As shown by the dashed lines in FIG. 6 , the strut members 68 of the leaflet clamp 66 may also form a V-shape when the leaflet clamp is in the collapsed configuration, but with the first ends 70 of the strut members positioned closer together than in the expanded configuration.

[0073] In certain embodiments, the body 13 of the frame 12 may be configured such that it has a barrel-shaped profile when in the collapsed configuration and an hourglass-shaped profile when in the expanded configuration. As used herein, the term "barrel-shaped profile" refers to a central portion 80 of the body 13 of the frame 12 being radially offset outward from the inflow end 16 and the outflow end 18 relative to the longitudinal axis 78 of the body of the frame 12, such that the diameter of the central portion of the body is greater than the diameter of the inflow end and the outflow end of the body. As used herein, the term "hourglass-shaped profile" refers to a central portion 80 of the body 13 being radially offset inward from the inflow end 16 and the outflow end 18 of the frame relative to the longitudinal axis 78, such that the diameter of the central portion of the body is less than the diameter of the inflow end and the outflow end of the body.

[0074] For example, Figure 6 and 7 Another embodiment of the frame 12 is illustrated with a single set of strut members 22 (e.g., outer strut members 22B) wherein the struts include seven rounded sections 40 (including ends 41 and 42), and corresponding openings 28. For purposes of illustration, the frame 12 is shown without the leaflet clamps 66. In some embodiments, the strut members 22 can be cut (e.g., laser cut) from a tube such that the strut members are curved and have a radius corresponding to the radius of the tube from which the struts are cut. Thus, the body 13 has a "natural" diameter D 1 , which corresponds to the diameter of the tube from which the strut member 22 is cut. In other embodiments, the strut member 22 can be cut from a sheet and bent to a desired curvature. In certain embodiments, the strut members 68 of the leaflet clamp 66 can also be cut from one or more tubes so that the strut members are bent to the natural diameter of the tube from which the struts are cut. The natural diameter of the strut member 68 can be greater than, equal to, or less than the natural diameter D of the strut member 22. 1 , it depends on the specific configuration.

[0075] like Figure 8 As shown in FIG. , when the prosthetic valve 10 is folded to a diameter smaller than the natural diameter D of the main body of the frame, 1 1. When the central portion 76 of the strut member 22 is in the radially collapsed configuration, the central portion 76 of the strut member 22 may tend to be arched radially outward, so that the body 13 of the frame 12 has a barrel-shaped profile. More specifically, as the diameter of the body 13 decreases, the first end 41 and the second end 42 may be positioned radially inward of the central portion 76 of the strut member 22, so that the first end 41 and the second end 42 are positioned closer to the longitudinal axis 78 of the frame than the central portion 76 of the strut member. In this way, the diameter D of the inflow end 16 of the body 13 is reduced. 2 and the diameter D of the outflow end 18 of the body 4 It may be smaller than the diameter D of the central portion 80 of the body. 3 In other words, the first end 41 and the second end 42 of the support member 22 may be located radially inward of the center portion 76 so that when the diameter of the main body of the frame 12 is reduced to its natural diameter D 1 When the diameter of the main body of the frame 12 is reduced to its natural diameter D 1 When viewed from above, the convex side of the strut member may be oriented away from the axis 78 .

[0076] On the contrary, Fig. 9 As shown in FIG. 1 , when the prosthetic valve 10 is expanded to the expanded configuration, the body 13 may be expanded beyond its natural diameter D 1 , giving the frame an hourglass-shaped profile. Fig. 9 , the first end 41 and the second end 42 of the support member 22 can be positioned radially outward of the central portion 76 of the support member 22, so that the first end 41 and the second end 42 are positioned farther from the longitudinal axis 78 of the frame than the central portion 76 of the support member 22. In this way, the diameter D of the inflow end 16 of the body 13 5 and the diameter D of the outflow end 18 of the body 7 It may be smaller than the diameter D of the central portion 80 of the body. 6 In other words, although the concave side of the strut member 22 is still oriented toward the axis 78, when the diameter of the body 13 is expanded beyond its natural diameter D 1 When the support member 22 is formed in the embodiment of the present invention, the first end portion 41 and the second end portion 42 of the support member 22 may be located radially outward of the central portion 76 .

[0077] While the fully assembled frame 12 including both the inner and outer group strut members 22A, 22B can assume the above-described shapes when in the collapsed and expanded configurations, the degree of barrel and hourglass profiles achieved can vary due to the constraints imposed by the joints 26 and the opposing helicities of the inner and outer group strut members 22A, 22B. In one representative example, the natural diameter D of the body of the frame is 1 Thus, when the frame is folded into a collapsed configuration, the diameter D of the central portion 80 of the body 13 is 3 When expanded to its functional size, the body 13 can be expanded beyond its natural diameter to obtain an hourglass shape. In the above example, the diameter D of the central portion 80 of the body 13 is 6 In its functional size it can be 24 mm to 26 mm. Figure 8 and Fig. 9 As shown in , as the frame is expanded, the length dimension of the frame 12 (eg, in the direction along the axis 78) may also be shortened.

[0078] Variations in the radial position of the inflow end 16 and the outflow end 18 of the body of the frame 12 relative to the central portion 80 can be used to move or actuate the leaflet clamp 66 between the open position and the closed position. Fig.10 The frame 12 is illustrated in a partially radially collapsed configuration in a native heart valve 86, wherein the body of the frame has a barrel-shaped profile. Although only the upper Figures 6 to 9 A set of strut members 22 (e.g., outer strut members 22B) are shown in FIG. 1 , but in practice, the frame may include Figure 1 The inner and outer brace members shown in FIG. Fig.10 , because the first end 70 of the strut member 68 of the leaflet clamp 66 is coupled to the outflow end 18 of the body 13, the second end 74 of the strut member 68 can be located radially outward of the first end 70. In this manner, the leaflet clamp 66 can define a corresponding leaflet receiving area 82 between the strut member 68 and the body 13 of the frame 12. The leaflet receiving area 82 can be configured to receive the leaflets 88 of the native heart valve 86 during implantation. The strut member 68 can also be arched or curved so that the concave side of the leaflet clamp 66 is oriented radially inward toward the central axis 78 and the convex side of the leaflet clamp 66 is oriented radially outward away from the central axis.

[0079] In contrast, when the prosthetic valve 10 is expanded to its functional size, the body 13 of the frame 12 may present a Fig.11 As described above, as the frame 12 is expanded, the support member 22 can be arched or bent so that the first end 41 and the second end 42 ( Fig. 9 ) is positioned radially outward of the central portion 76. This can cause the leaflet clamp 66 to move (e.g., by pivoting) to a closed position in which the first end 70 of the strut member 68 is positioned at substantially the same radial distance from the axis 78 as the second end 74, or is positioned radially outward of the second end 74. In the closed position, the second end 74 can be adjacent to or in contact with the body 13 of the frame 12. In this manner, the leaflet clamp 66 can clamp, grip, or clamp the native leaflets 88 of the heart valve 86 against the outer strut members 22B of the frame 12 and the inner surface of the clamp 66.

[0080] like Fig.11 As shown in FIG, in the radially expanded configuration of the frame with the clamp in the closed position, the strut member 68 of the clamp can be slightly arched to match the shape of the frame body so that the first end 70 and the second end 74 are located radially outward of the center portion of the strut member 68. In other words, Fig.10 , the concavity of the strut member 68 can be reversed such that the concave side of the leaflet clamp 66 is oriented away from the central axis 78 and the convex side of the clamp is oriented radially inward toward the body and the central axis.

[0081] The support member 22 and / or the support member 68 can be made of any of a variety of biocompatible materials. For example, in some embodiments, the support member 22 and / or the support member 68 can be made of any of a variety of metal alloys (including nickel-titanium alloys such as nitinol, or stainless steel, etc.).

[0082] The disclosed prosthetic valve embodiments can be radially collapsed and delivered percutaneously to the heart using any of a variety of delivery systems. For example, Fig.12 shows a configuration with Figures 1 to 11 A representative example of a delivery assembly 100 for use with a prosthetic valve 10 of the present invention is provided in the United States and is described in detail in U.S. Publication No. 2018 / 0153689. The delivery assembly 100 may include a handle 102, an elongated shaft 104 extending distally from the handle 102, and a plurality of first actuation members 106 (e.g., in the form of positioning tubes) extending through the shaft and extending distally outwardly from a distal end 108 of the shaft 104. The first actuation members 106 may be coupled to respective expansion units 54 of the valve frame 12.

[0083] Delivery assembly 100 may include a second actuation member (not shown) extending coaxially through the first actuation member and connected to the respective inner member 56. To produce radial expansion of the prosthetic valve, first actuation member 106 is actuated to apply a distally directed force to frame 12, and / or the second actuation member is actuated to apply a proximally directed force to inner member 56. To produce radial compression of the prosthetic valve, first actuation member 106 is actuated to apply a proximally directed force to frame 12, and / or the second actuation member is actuated to apply a distally directed force to inner member 56.

[0084] Initially, the prosthetic valve 10 can be in a radially collapsed configuration within the sheath 110 of the shaft 104. During delivery of the prosthetic valve, the sheath 110 holds the clamp 66 against the outer surface of the frame 12. When the distal end of the delivery device has been advanced through the patient's vasculature to the treatment site (e.g., at the ascending aorta), the prosthetic valve 10 can be advanced from the sheath 110, such as by using a rotatable actuator 112 on the handle 102. The clamp is desirably sufficiently resilient so that the clamp 66 can automatically self-expand away from the frame 12 when the prosthetic valve is deployed from the sheath. Fig.10 . The prosthetic valve 10 may then be positioned at the treatment site, expanded, and deployed using a release assembly generally indicated at 114. For example, returning to Fig.10 and Fig.11 , the delivery assembly 100 can be used to position the prosthetic valve 10 in the annulus 84 of a native heart valve 86 (e.g., an aortic valve). When the surgeon determines that the native leaflets 88 are properly positioned in the leaflet receiving area 82, the delivery assembly 100 can be used to expand the prosthetic valve 10 so that the leaflet clamps 66 are removed from the prosthetic valve 10. Fig.10 Move to the open position shown in Fig.11 , to clamp the leaflets 88 against the frame 12.

[0085] In an optional embodiment, the leaflet clamp 66 may include a single member, rather than two strut members 68 coupled together. For example, in some embodiments, the leaflet clamp 66 may include a single strut member that is bent so that it is U-shaped or V-shaped similar to the leaflet clamp 66. Such a strut member can be made of, for example, any of a variety of shape memory alloys, so that the strut member can be folded and can rebound to its functional shape after expansion of the frame. In another configuration, the leaflet clamp 66 may include a single straight strut member similar to the strut member 68, which is configured to move between an open position and a closed position with the frame 12. Such as the following reference Fig.17As described, in certain embodiments, the leaflet clamp 66 can also include any of a variety of atraumatic coverings, such as woven or nonwoven fabrics, any of a variety of electrospun coatings, and the like.

[0086] Compared with known prosthetic valve docking mechanisms, the leaflet clamp embodiments described herein can provide significant advantages. For example, because the leaflet clamp is part of the frame, a separate docking member and associated delivery device are not required. In addition, because the leaflet clamp is actuated between the open position and the closed position by the movement of the frame between the contracted configuration and the expanded configuration, the leaflet clamp can be easily reopened and the prosthetic valve can be repositioned until the surgeon is satisfied with the placement of the prosthetic valve. The related advantage of the mechanically expandable frame is that a capsule is not required to expand the frame to its functional size, and therefore, there is no blockage of blood flow during valve expansion. Moreover, since the leaflet clamp is actuated by the movement of the prosthetic valve rather than by self-expansion, the leaflet clamp does not need to be made of superelastic or shape memory materials. Instead, the strut members forming the clamp can be made of relatively stronger and / or harder materials (such as stainless steel or cobalt-chromium alloy). In use, when the frame radially expands and shrinks to move the clamp between their open position and closed position, the strut members of the clamp are deformed within their elastic range.

[0087] Additionally, while the illustrated configuration is suitable for implantation in the aortic valve, the frame and leaflet clamp may also be configured for implantation in the mitral and / or tricuspid valves. For example, by reversing the orientation of the leaflet clamp 66 so that the first end 70 of the strut member 68 is coupled to the apex 24 at the lower end 16 of the frame (e.g., at the outflow end of the frame when implanted in the mitral valve position), the leaflet clamp may be configured for the mitral and / or tricuspid valves.

[0088] Figures 13 to 15 The frame 12 including the inner and outer struts 22A, 22B and the leaflet clamps 66 are illustrated in various states of expansion. Fig.13 The example is in its natural diameter D 1 12. For purposes of illustration, referring to the representative outer strut member 22B(1), in the configuration shown, the strut member can include seven rounded intermediate sections or portions 40. The intermediate portions 40 can be part of seven corresponding hinges or joints 26A to 26G that couple the outer strut member 22B(1) to the inner strut member 22A. The first end 70 of the strut 68 can be coupled to the joint 26G at the outflow end 18 of the frame. Fig.13 At the natural diameter shown, the struts 68 of the leaflet clamp 66 can remain parallel to and / or in contact with the outer strut members 22B of the frame.

[0089] Fig.14 1. The frame 12 is illustrated as being folded into a collapsed configuration for delivery. In the collapsed configuration, both the inner and outer supports 22A, 22B can be bent radially inward at the ends of the frame. For example, the struts 22A and 22B can be bent radially inward starting at the location of the joint 26B at the inflow end 16 of the frame and moving in an upstream direction toward the joint 26A. Similarly, the struts 22A and 22B can be bent radially inward at their opposite ends, starting at approximately the joint 26F, and moving in a downstream direction toward the joint 26G at the outflow end 18 of the frame. Thus, the inflow end 16 of the frame 12 at the level of the joint 26A can have a diameter D 2 , while the outflow end of the frame at the level of the joint 26G may have a diameter that may be approximately equal to D 2 Diameter D 4 . Diameter D 2 and D 4 can be smaller than the diameter D of the central portion 80 of the frame 3 For example, in some embodiments, from about the level of joint 26B to about the level of joint 26F, frame 12 may have a diameter D 3 , so that the frame has a barrel-shaped profile. Because struts 22A and 22B bend radially inward from joint 26F, struts 68 of leaflet clamp 66 coupled to the frame at joint 26G can be angled away from the frame in the open position.

[0090] Fig.15 The frame 12 is shown expanded to an expanded configuration. The frame 12 may have an hourglass-shaped profile, with joints 26A and 26G disposed radially outward of joints 26B to 26F therebetween. In this configuration, the frame may have a diameter D at joint 26A of the inflow end 16. 5 , and may have a diameter D at the joint 26G of the outflow end 18 7 The center portion 80 may have a minimum diameter D located approximately between the joints 26C and 26D. 6 Because strut members 22A and 22B twist, bend or flare radially outward at the inflow and outflow ends of the frame, struts 68 of leaflet clamp 66 can be angled inwardly toward the frame. As described above, this can allow leaflet clamp 66 to clamp the leaflets of the native heart valve against the outside of the frame.

[0091] In other embodiments, strut members 22A and / or 22B may be bent radially inward at locations other than joints 26B and 26F. For example, in other embodiments, strut members 22A and / or 22B may be bent radially inward at joints 26C and 26E. In yet other embodiments, frame 12 may be configured such that outflow end 18 bends radially inward in the collapsed configuration and bends radially outward in the expanded configuration to actuate leaflet clamps, while struts at inflow end 16 exhibit little or no curvature, or remain parallel.

[0092] Fig.16 Another embodiment of the frame 12 in the expanded configuration is illustrated in which the strut members 68 of the leaflet clamp are configured to bend along the outer surface of the frame in a direction from the outflow end 18 toward the inflow end 16. More specifically, the strut members 68 can be arched or curved such that the concave side of the leaflet clamp 66 is oriented radially away from the longitudinal axis of the frame and the convex side of the leaflet clamp is disposed adjacent to or against the outer strut member 22B.

[0093] Fig.17 A frame 12 including a covering 71 disposed on the strut member 68 of the leaflet clamp 66 is illustrated. The covering 71 may include a tubular body that can receive the strut 68. In the illustrated embodiment, the covering 71 includes a first tubular portion 73 and a second tubular portion 75 that are connected to a common third tubular portion 77, so that the covering corresponds to the V-shape of the leaflet clamp 66. In other embodiments, the covering 71 may include a liner having a single cavity or opening or a separate liner member, the liner having a single cavity or opening being configured to receive two struts of the leaflet clamp 66, and the separate liner member being configured to receive a single strut 68 of each leaflet clamp. The covering may include a woven or non-woven fabric, a knitted fabric, and / or may include a polymeric layer, such as a dip-coated silicone layer or sleeve, or an electrospun expanded polytetrafluoroethylene (ePTFE) layer. The covering may also include natural tissue. As described above, the covering 71 can provide a cushion to protect the natural valve leaflets clamped between the leaflet clamp 66 and the frame 12, and / or reduce the risk of injury to surrounding tissue. The covering 71 can be configured to allow the leaflet clamp 66 to move between an open position and a closed position when the frame expands and collapses. Such a covering can also be applied to the struts 22 of the frame, and / or around the entire frame. Representative frame coverings that can be used in conjunction with the frames described herein can be found in U.S. Publication No. 2018 / 0206982 and U.S. Application No. 16 / 252,890.

[0094] Explanation of terms

[0095] For the purpose of this specification, certain aspects, advantages, and novel features of embodiments of the present disclosure are described herein. The disclosed methods, devices, and systems should not be construed as limiting in any way. Instead, the present disclosure is directed to all novel and non-obvious features and aspects of the various disclosed embodiments, both individually and in various combinations and sub-combinations with one another. The methods, devices, and systems are not limited to any specific aspect or feature or combination thereof, nor do the disclosed embodiments require the presence of any one or more specific advantages or the resolution of any one or more specific problems.

[0096] Although some operations of the disclosed embodiments are described in a particular sequential order for ease of presentation, it should be understood that this description encompasses rearrangement unless the specific language set forth below requires a particular ordering. For example, in some cases, the operations described in sequence may be reset or performed simultaneously. Moreover, for simplicity, the accompanying drawings may not show the various ways in which the disclosed methods can be used in conjunction with other methods. In addition, the specification sometimes uses terms such as "providing" or "implementing" to describe the disclosed methods. These terms are high-level abstractions of the actual operations performed. The actual operations corresponding to these terms may vary depending on the specific implementation and can be easily discerned by a person of ordinary skill in the art.

[0097] As used in this application and in the claims, the singular forms "a," "an," and "the" include the plural forms unless the context clearly dictates otherwise. Additionally, the term "comprising" means "including." Further, the terms "coupled" and "associated" generally refer to electrical, electromagnetic, and / or physical (e.g., mechanical or chemical) couplings or connections, and do not exclude the presence of intervening elements between coupled or associated items in the absence of specific language to the contrary.

[0098] In the context of the present application, the terms "lower" and "upper" are used interchangeably with the terms "inflow" and "outflow", respectively. Thus, for example, the lower end of the valve is its inflow end, and the upper end of the valve is its outflow end.

[0099] As used herein, the term "proximal" refers to a position, direction or portion of a device that is closer to a user and further from an implantation site. As used herein, the term "distal" refers to a position, direction or portion of a device that is away from a user and closer to an implantation site. Thus, for example, the proximal movement of a device is the movement of the device toward the user, while the distal movement of the device is the movement of the device away from the user. Unless otherwise clearly defined, the terms "longitudinal" and "axial" refer to an axis extending in the proximal and distal directions.

[0100] Unless otherwise stated, all numerals used in the specification or claims to represent dimensions, number of components, angles, molecular weights, percentages, temperatures, forces, times, etc., are understood to be modified by the term "about". Therefore, unless otherwise stated, numerical parameters implicitly or explicitly stated are approximate values, which may depend on the desired properties sought and / or the detection limits under the test conditions / methods familiar to those of ordinary skill in the art. Unless the word "about" is narrated, when the embodiment is directly and clearly distinguished from the prior art discussed, the embodiment numerals are not approximate. In addition, not all alternatives narrated herein are equivalent.

[0101] In view of the many possible embodiments to which the disclosed technical principles can be applied, it should be recognized that the illustrated embodiments are only preferred examples and should not be considered to limit the scope of the present disclosure. On the contrary, the scope of the present disclosure is at least as broad as the appended claims. Therefore, we claim protection for all that fall within the scope and spirit of these claims.

Claims

1. A frame for a prosthetic heart valve, comprising: a plurality of strut members arranged to form an annular body of the frame and coupled together by a plurality of pivot joints, the body of the frame being radially collapsible to a collapsed configuration and radially expandable to an expanded configuration, and the body of the frame having an inflow end and an outflow end; as well as a plurality of leaflet clamps disposed on an exterior of the body of the frame and coupled to the strut members, the plurality of leaflet clamps being movable between an open position corresponding to a collapsed configuration of the body of the frame and a closed position corresponding to an expanded configuration of the body of the frame; and Wherein movement of the body of the frame between the collapsed configuration and the expanded configuration causes corresponding movement of the leaflet clamp between the open position and the closed position.

2. The framework of claim 1, wherein: The leaflet clamp includes a first end coupled to a body of the frame and a free second end; and The free second end is spaced radially outward from the body of the frame when the leaflet clamp is in the open position.

3. The frame of claim 2, wherein the free second end is disposed adjacent to the body of the frame when the leaflet clamp is in the closed position.

4. The frame of any one of claims 1 to 3, wherein: The strut members have respective inflow ends located at an inflow end of a body of the frame, respective outflow ends located at an outflow end of the body of the frame, and respective central portions between the inflow ends and the outflow ends; as well as When the frame is in the expanded configuration, the central portions of the strut members are offset radially inwardly from the inflow and outflow ends of the strut members relative to a longitudinal axis of the frame such that the body of the frame has an hourglass-shaped profile.

5. The frame of claim 4, wherein when the frame is in the collapsed configuration, the center portion of the strut member is radially offset outward from the respective inflow end and outflow end of the strut member relative to the longitudinal axis of the frame so that the body of the frame has a barrel-shaped profile.

6. The frame of any one of claims 1 to 5, wherein the leaflet clamps each include a pair of strut members pivotally coupled to strut members of a body of the frame.

7. The frame of claim 6, wherein: The strut members of the leaflet clamp each include a first end and a second end; and The second end of the strut member of the leaflet clamp is spaced radially outward from the body of the frame when the leaflet clamp is in the open position.

8. The frame of claim 7, wherein the second ends of the strut members of each leaflet clamp are coupled to one another such that the leaflet clamps are V-shaped when the frame is in the expanded configuration.

9. The frame of claim 7 or claim 8, wherein the first end of the strut member of the leaflet clamp is coupled to the apex of the outflow end of the body of the frame.

10. A prosthetic heart valve comprising: The frame according to any one of claims 1 to 9; as well as A leaflet structure is at least partially disposed within the frame.

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