Mechanically expandable heart valve with leaflet clamps

Abstract

To provide improvements to devices and methods for engaging the leaflets of a native heart valve when implanting a prosthetic heart valve.SOLUTION: A frame for a prosthetic heart valve includes a plurality of strut members arranged to form an annular main body and coupled together by a plurality of pivot joints. The main 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 clamps disposed on the exterior of the main 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 frame and a closed position corresponding to the expanded configuration of the frame. Motion of the main body of the frame between the collapsed configuration and the expanded configuration causes corresponding motion of the leaflet clamps between the open position and the closed position.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] SUMMARY The present disclosure relates to implantable, mechanically expandable prosthetic devices, such as prosthetic heart valves, as well as methods and delivery assemblies for such prosthetic devices. [Background technology]

[0002] The human heart can suffer from a variety of valvular diseases that can result in significant dysfunction of the heart and can ultimately require replacement of the native valve with a prosthetic valve. There are several known prosthetic valves and several known methods of implanting these prosthetic valves in humans.

[0003] A variety of surgical techniques can be used to replace or repair diseased or damaged valves. Stenosis and other valvular heart diseases cause thousands of patients to undergo surgery each year to replace their defective native heart valves with prosthetic valves. Another, less drastic method to treat defective valves is through repair or reconstruction, which is typically used for valves with minimal calcification. The problem with surgical therapy is the significant risk it poses to chronically unwell patients, and surgical repair is associated with high morbidity and mortality.

[0004] When a native valve is replaced, the surgical implantation of a prosthetic valve typically requires open-chest surgery during which the heart is stopped and the patient is placed on cardiopulmonary bypass (also called "cardiopulmonary bypass"). In one common surgical procedure, the leaflets of the diseased native valve are excised and a prosthetic valve is sutured to the surrounding tissue at the annulus. Due to the trauma associated with the procedure and the duration of the associated extracorporeal blood circulation, some patients are unable to tolerate the surgical procedure or die shortly thereafter. It is well known that the risks to the patient increase with the length of time required in the extracorporeal circulation. Due to these risks, a significant number of patients with defective native valves are deemed inoperable because their physical condition is too frail to tolerate the procedure. By some estimates, more than 50% of subjects over 80 years of age who suffer from valvular heart disease, such as valvular stenosis, valvular regurgitation, etc., are unable to undergo valve replacement surgery.

[0005] Due to the drawbacks associated with traditional open-chest surgery, percutaneous and minimally invasive surgical approaches have attracted attention. In one technique, prosthetic valves are configured to be implanted in a much less invasive procedure by catheterization. For example, U.S. Patent No. 5,399,433 and U.S. Patent No. 5,399,433, which are incorporated herein by reference, describe a collapsible transcatheter heart valve that can be percutaneously introduced in a compressed state on a catheter and expanded at a desired location by inflation of a balloon or by utilizing a self-expanding frame or stent. [Prior art documents] [Patent documents]

[0006] [Patent Document 1] U.S. Patent No. 5,411,522 [Patent Document 2] U.S. Patent No. 6,730,118 [Patent Document 3] US Patent Application Publication No. 2018 / 0153689 [Patent Document 4] U.S. Patent Application Serial No. 16 / 105,353 [Patent Document 5] US Patent Application Publication No. 2014 / 0296962 [Patent Document 6] US Patent Application Publication No. 2018 / 0206982 [Patent Document 7] U.S. Patent Application Serial No. 16 / 252,890 Summary of the Invention [Problem to be solved by the invention]

[0007] An important design consideration is the ability of the prosthetic heart valve to remain in place after deployment without displacement. In particular, there is a need for improved devices and methods for engaging the leaflets of a native heart valve during implantation of a prosthetic heart valve. [Means for solving the problem]

[0008] Certain embodiments of the present disclosure relate to a frame for a prosthetic heart valve including a leaflet clamp. In an exemplary embodiment, the frame for the prosthetic heart valve comprises a plurality of strut members arranged to form an annular main body of the frame and connected to one another by a plurality of pivot joints. The main body of the frame is radially foldable to a folded configuration and radially expandable to an expanded configuration, the main body of the frame having an inflow end and an outflow end. The frame further comprises a plurality of leaflet clamps disposed on the exterior of the main body of the frame and connected to the strut members. The plurality of leaflet clamps are movable between an open position corresponding to the folded configuration of the main body of the frame and a closed position corresponding to the expanded configuration of the main body of the frame. Movement of the main body of the frame between the folded and expanded configurations correspondingly moves the leaflet clamps between the open and closed positions.

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

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

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

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

[0013] In some embodiments, each leaflet clamp comprises a pair of strut members pivotally connected to strut members of the main body of the frame.

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

[0015] In some embodiments, the second end portions 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.

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

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

[0018] In another exemplary embodiment, a frame for a prosthetic heart valve includes a plurality of strut members arranged to form an annular main body. The main body of the frame is radially foldable into a folded configuration and radially expandable into 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 end portions located at the inflow end of the main body, respective outflow end portions located at the outflow end of the main body, and respective central portions between the inflow and outflow end portions. When the frame is in the expanded configuration, the central portions of the strut members are offset radially inwardly from the inflow end portions and from the outflow end portions of the strut members relative to the longitudinal axis, such that the main body of the frame has an hourglass-shaped profile.

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

[0020] In some embodiments, the frame further comprises a plurality of leaflet clamps disposed externally of the main 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 main body of the frame and a closed position corresponding to an expanded configuration of the main body of the frame.

[0022] In some embodiments, each leaflet clamp comprises a pair of strut members pivotally connected to strut members of the main body of the frame.

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

[0024] In some embodiments, the second end portions 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.

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

[0026] In some embodiments, the strut members of the main body of the frame are connected to one another by a number of pivot joints.

[0027] In another exemplary embodiment, a method of implanting a prosthetic heart valve includes advancing a prosthetic heart valve in a collapsed configuration to a native heart valve with a delivery instrument. The prosthetic heart valve includes a plurality of strut members connected to one another by a plurality of pivot joints and arranged to form a frame having an annular main body. The main 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 disposed on the exterior of the main 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 main body of the frame and a closed position corresponding to the expanded configuration of the main body of the frame. The method further includes positioning the prosthetic heart valve such that leaflets of the native heart valve are located between respective leaflet clamps and the main body of the frame, and radially expanding the prosthetic heart valve from the collapsed configuration to the expanded configuration such that the leaflet clamps move from the open position to a closed position to clamp the leaflets against the prosthetic heart valve.

[0028] In some embodiments, the leaflet clamp comprises a first end portion coupled to the outflow end of the main body of the frame and a second free end portion, and the step of radially expanding the prosthetic heart valve further includes expanding the main body of the frame beyond a natural diameter of the strut member such that the outflow end of the main body of the frame moves radially outward from a central portion of the main body of the frame and the second free end portion of the leaflet clamp moves adjacent to the main 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, which proceeds with reference to the accompanying drawings. [Brief description of the drawings]

[0030] [Figure 1] FIG. 1 is a perspective view of an exemplary embodiment of a prosthetic heart valve including a mechanically expandable frame having multiple leaflet clamps. [Diagram 2] FIG. 2 is a side view of the frame of the prosthetic heart valve of FIG. 1. [Diagram 3] 1 is a perspective view of an exemplary embodiment of a support member. [Figure 4A] FIG. 1 is a perspective view of an exemplary embodiment of a pivot joint. [Figure 4B] FIG. 4B is a plan view of the pivot joint of FIG. 4A. [Diagram 5] FIG. 3 is a side view of the frame of FIG. 2 in a radially folded configuration. [Figure 6] 3 is a side view of a set of strut members of the frame of FIG. 2, with the strut members arranged in the form of a prosthetic heart valve at the strut members' natural diameters. FIG. [Figure 7] FIG. 7 is a plan view of the support member of FIG. 6. [Figure 8] 7 is a side view showing the position of the strut member of FIG. 6 when the frame of FIG. 2 is radially collapsed to a diameter smaller than the natural diameter of the strut member. [Figure 9]7 is a side view showing the position of the strut member of FIG. 6 when the frame of FIG. 2 is radially expanded to a diameter larger than the natural diameter of the strut member. [Figure 10] 7 is a side view showing the strut member of FIG. 6 in a collapsed configuration within a native aortic valve and including a leaflet clamp in an open configuration. [Figure 11] 7 is a side view showing the strut member of FIG. 6 in an expanded configuration such that the leaflet clamp is in a closed configuration and engages the native leaflets of the aortic valve. [Figure 12] FIG. 1 is a perspective view of an exemplary embodiment of a delivery device. [Figure 13] 13 is a side view of another embodiment of a frame including an inner strut member, an outer strut member, and a leaflet clamp, the frame being at its natural diameter. FIG. [Figure 14] FIG. 14 is a side view of the frame of FIG. 13 in a folded configuration with the leaflet clamps in an open position. [Figure 15] FIG. 14 is a side view of the frame of FIG. 13 in an expanded configuration with the leaflet clamps in a closed position. [Figure 16] FIG. 14 is a side view of the frame of FIG. 13 in an expanded configuration with the leaflet clamps in a closed position and curved to correspond to the curvature of the outer contour of the frame. [Figure 17] FIG. 14 is a side view of the frame of FIG. 13 showing a cover placed over the leaflet clamp. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0031] The present disclosure relates to embodiments of implantable prosthetic devices, particularly implantable prosthetic valves, and methods of implanting such devices. In certain embodiments, the prosthetic device includes a prosthetic heart valve and may be configured to be implanted in any of the native heart valves (aortic, mitral, pulmonary, and tricuspid). Furthermore, the prosthetic heart valve may be, for example, a transcatheter heart valve, a surgical heart valve, or a minimally invasive heart valve. The prosthetic valve may also include other types of valves that can be implanted in other body lumens outside the heart, or heart valves that can be implanted in the heart at locations other than the native valves, such as trans-atrial or trans-ventricular septum valves.

[0032] The disclosed prosthetic heart valve is particularly suitable for implantation in a native aortic valve. In the context of prosthetic aortic valves, the terms "lower" and "upper" are used interchangeably with the terms "inflow" and "outflow", respectively, for convenience. Thus, for example, in the orientation shown in the drawings, 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, in implantation at the mitral valve, the upper end of the prosthetic valve is the inflow end, and the lower end of the valve is the outflow end.

[0033] In some embodiments, the prosthetic valves described herein may include a docking mechanism configured as a leaflet clamp to clamp the leaflets of the native heart valve against the prosthetic heart valve. In some configurations, the leaflet clamps may be movable between an open configuration corresponding to a radially folded configuration of the prosthetic valve and a closed configuration corresponding to a radially expanded configuration of the prosthetic valve. In some embodiments, the diameter of the frame of the prosthetic valve may vary along the longitudinal axis of the frame. The diameters of various parts of the frame may also vary between the folded and expanded configurations. For example, in some configurations, the inflow and outflow ends of the frame may be disposed radially inward of a central portion of the frame when the frame is in the folded configuration, such that the frame has a convex or barrel-shaped profile. Conversely, when the frame is in the expanded configuration, the central portion of the frame may be disposed radially inward of the inflow and outflow ends of the frame, such that the frame exhibits a concave or hourglass-shaped outer profile. When the leaflet clamp is coupled to the frame, this radial movement of the inflow and outflow ends of the frame relative to a central 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 disposed against or adjacent to the frame.

[0034] For example, FIG. 1 illustrates a representative embodiment of a prosthetic heart valve 10. The prosthetic valve 10 may include a mechanically expandable stent or frame 12 having an annular main body 13 and a leaflet structure 14 located within 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 multiple leaflets 20, for example, three leaflets arranged to fold in a tricuspid configuration similar to the aortic valve. Alternatively, the prosthetic valve may include two leaflets 20 configured to fold in a bicuspid configuration similar to the mitral valve, or more than three leaflets, depending on the particular application. The prosthetic valve 10 may also include one or more sealing members to help seal the prosthetic valve against surrounding tissue once implanted. The sealing members may take the form of an annular skirt formed, for example, from a suitable fabric (e.g., PET) or natural tissue (e.g., pericardial tissue). The prosthetic valve may include an annular skirt on the inner surface of the frame 12 and / or on the outer surface of the frame 12.

[0035] The frame 12 may include a plurality of interconnected strut members 22 (also referred to as "first strut members") arranged in a lattice-type pattern and forming a plurality of apexes 24 at the inflow end 16 and the outflow end 18 of the prosthetic valve main body 13. In the illustrated configuration, the frame 12 includes a first set of strut members 22A and a second set of strut members 22B. The first set of strut members 22A are located radially inward of the second set of strut members 22B, such that the strut members 22B are on the outside of the frame. In the illustrated embodiment, the strut members 22A may be angled in a first direction and may extend helically about the longitudinal axis 78 of the frame 12, and the strut members 22B may be angled in an opposite direction to the strut members 22A and may extend helically about the longitudinal axis 78 in an opposite direction to the helicity of the strut members 22A.

[0036] FIG. 2 shows a representative embodiment of the frame 12 of the prosthetic valve 10 without valvular structures for illustrative purposes, and FIG. 3 shows a representative embodiment of the strut members 22 in further detail. With reference to FIG. 3, the strut members 22 may define a plurality of openings 28 spaced 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 a first set of strut members 22A overlaps a second set of strut members 22B. The strut members 22 may also include openings 28 defined at their respective end portions, whereby each strut member 22A and 22B may be coupled to one another to form apexes 24 at the inflow and outflow ends of the frame.

[0037] As shown in FIG. 3, each strut member 22 may have an offset or zigzag pattern defined by a plurality of offset linear portions or segments 38. The linear segments 38 in the illustrated embodiment are disposed end-to-end relative to one another, with adjacent ends interconnected to one another by intermediate segments 40. The struts 22 may have an enlarged first end portion 41 at the inflow end of the frame and a second end portion 42 at the outflow end of the frame. Thus, the first end portion 41 and the second end portion 42 may form apexes 24 at the inflow and outflow ends of the frame. The strut members 22 may also include a central portion 76 located midway between the first end portion 41 and the second end portion 42.

[0038] Each linear segment 38 may be slightly laterally offset from an adjacent linear segment 38 in a direction perpendicular to the length of the strut 22 to provide the strut with a zigzag pattern. The intermediate segment 40 and each of the end portions 41 and 42 may have a respective opening 28 at its geometric center for receiving a fastener 30 (FIG. 4B). The amount of offset of each linear segment 38 relative to an adjacent linear segment along the length of the strut 22 may be constant such that an axis 44 may pass through the opening 28 of each intermediate segment 40 along the entire length of the strut. In alternative embodiments, the amount of offset between two adjacent linear segments 38 may vary along the length of the strut. For example, the amount of offset between linear segments 38 adjacent to the outflow end of the frame may be greater than the amount of offset between linear segments 38 adjacent to the inflow end of the frame, or vice versa.

[0039] The linear segment 38 may include at least substantially flat or linear opposing longitudinal edges 46a, 46b extending between the curved or rounded edges 48 of the intermediate segment 40. In alternative embodiments, the opposing edges 48 of the intermediate segment 40 may be substantially flat or linear edges extending at an angle between the respective ends of the edges 46a, 46b of the linear segment 38.

[0040] As best shown in FIG. 3, a width W1 of each linear segment 38 is defined as the distance measured between 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. A width W2 of each intermediate segment 40 and end portions 41, 42 may be greater than the width W1 of the linear segment 38.

[0041] In alternative embodiments, the width W1 of each linear segment 38 may vary along the length of the strut. For example, the width W1 of the linear segment 38 adjacent the inflow end of the frame may be greater than the width W1 of the linear segment 38 adjacent the outflow end of the frame, or vice versa. Furthermore, when the width W1 of the linear segment 38 varies along the length of the strut 22, the linear segment may have one longitudinal edge 46a or 46b that is collinear with the longitudinal edge of the adjacent linear segment on the same side of the strut, and 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, the strut 22 may have an overall zigzag or offset pattern due to the varying widths W1 of the linear segments.

[0042] In alternative embodiments, the struts 22 may have linear segments 38 that are not offset from one another, i.e., the struts are substantially rectangular and the longitudinal sides of each strut extend continuously from one end of the strut to the opposite end of the strut, without any offset portions (e.g., in the same manner as strut 68 described below).

[0043] Returning to FIGS. 1 and 2, strut member 22A of the first set of strut members may be pivotally connected to strut member 22B of the second set of strut members by a hinge or joint 26. In one embodiment, joint 26 may be formed by inserting fasteners 30 (e.g., rivets, pins, etc.) through openings 28 where the strut members overlap, including at apexes 24. FIGS. 4A and 4B show a representative joint 26 in further detail. With reference to FIG. 4A, a spacer 32, such as a washer or bushing, may be disposed within the joint between each strut member 22A and 22B. Spacer 32 may aid strut members 22A and 22B in moving relative to one another to expand and / or collapse the frame. Spacer 32 may also act to space strut members 22A, 22B from one another. In other embodiments, joint 26 need not include spacer 32 and / or strut members 22 may be spaced apart in another manner.

[0044] 4B, in certain embodiments, the fasteners 30 do not extend radially outward from the openings 28 of the strut members, but may be contained entirely within the openings. For example, the openings 28 on the radially outermost struts 22B may each include a counterbore or enlarged recessed portion 34 sized to receive a head portion 36 of a respective fastener 30 (e.g., a rivet). The head portion 36 may be received entirely within the counterbore 34 and not extend radially outward from the counterbore. For example, the head portion 36 may be flush with the outer surface of the struts 22B. In this manner, the fasteners 30 do not increase or contribute to the overall crimp profile of the prosthetic valve, and do not impede or overstress a delivery sheath into which the valve may be placed during delivery.

[0045] Joints 26 may allow strut members 22A to pivot relative to strut members 22B as frame 12 is expanded or contracted, such as during assembly, preparation, or implantation of prosthetic valve 10. For example, frame 12 (and thus prosthetic valve 10) may be manipulated into a radially compressed or contracted configuration (see FIG. 5) and inserted into a patient for implantation. Once inside the body, prosthetic valve 10 may be manipulated into an expanded state (FIG. 1) and then released from the delivery instrument, as described further below.

[0046] The frame 12 may be configured to protect soft components (e.g., the leaflets 20 and any skirts, sutures, etc. that form part of the prosthetic valve) from being pinched or cut by the frame during crimping and expansion of the prosthetic valve. For example, FIG. 5 shows the frame 12 of FIG. 1 in a radially folded configuration. The offset or zigzag pattern of the strut segments 38 may help to circumferentially space the struts 22 when the frame 12 is in a radially compressed state. As shown, the open lattice structure of the frame 12, which defines open cells 50 between the struts 22, may be maintained even when the frame 12 is fully compressed or contracted. For example, with reference to FIG. 5, the width of the cells 50 along the length of the frame 12 may vary between adjacent struts, but a gap 52 remains in the center of the cell 50 between two adjacent pivot joints 26. The spaced nature of the struts 22, including the gap 52, may help to protect the soft components of the prosthetic valve as the frame 12 expands or contracts. The gaps 52 created by the offset configuration of the struts 22 can protect the leaflets 20, skirts such as a perivalvular leakage skirt (not shown), and / or sutures from being pinched or sheared between adjacent struts 22 when the prosthetic valve is radially compressed. In this manner, soft components of the prosthetic valve are protected from damage that may result from contact with the metal struts of the frame.

[0047] Returning to FIG. 1 , the frame 12 may include a plurality of post members 54. In the illustrated configuration, the post members 54 are configured as actuator components, which may also function as release and lock units (also referred to as lock assemblies or expansion units) configured to radially expand and contract the frame and maintain the frame in a desired expanded state. In the illustrated configuration, the frame 12 may include three actuator components 54 coupled to the frame 12 at circumferentially spaced locations, although the frame may include more or fewer actuator components depending on the particular application. Each of the actuator components 54 may generally include an inner member 56, such as an inner tubular member, and an outer member 58, such as an outer tubular member, concentrically disposed around the inner member 56. The inner and outer members 56 and 58 may be telescopically movable longitudinally relative to one another to radially expand and contract the frame 12, as further described in U.S. Pat. No. 6,399,323.

[0048] In the illustrated configuration, the inner members 56 can have a distal end portion 60 that is connected (e.g., by a connecting element such as a pin member) to the inflow end 16 of the frame 12. In the illustrated embodiment, the inner members 56 are each connected to the frame at a respective apex 24 at the inflow end 16 of the frame. The outer members 58 can be connected to the apex 24 at the outflow end 18 of the frame 12, for example, at a central portion of the outer member as shown in FIG. 1 or at a proximal end portion of the outer member, depending on the particular application.

[0049] The inner member 56 and the outer member 58 may telescope relative to one another 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 manner, the actuator component 54 allows the prosthetic valve to be fully or partially expanded to various diameters inside the patient's body and maintains the prosthetic valve in a partially or fully expanded state. The inner member 56 and the outer member 58 have respective locking elements that are configured to engage one another and prevent radial compression of the frame when the frame is expanded to a desired expanded diameter and the locking elements are actuated by a user, as further disclosed in U.S. Patent No. 5,999,333.

[0050] The prosthetic valve 10 may include various other types of actuators and / or locking devices to control the radial expansion of the valve and / or maintain the valve in an expanded state. In some embodiments, for example, the actuator component 54 may be a screw actuator configured to radially expand and collapse the frame 12 by rotation of one of the actuator components. For example, the inner member 56 may be configured as a screw having male threads that engage with female threads of a corresponding outer component. In some embodiments, the internal friction or resistance of the threads within the screw actuator may be sufficient to maintain the frame in a desired expanded state. Further details regarding the screw actuators and various other types of actuators and locking devices that may be incorporated into the prosthetic valve are disclosed in U.S. Patent No. 5,399,433; U.S. Patent No. 5,399,433, filed Aug. 20, 2018; and U.S. Patent No. 5,399,433.

[0051] 1 , the prosthetic valve 10 may include a number of commissure support elements configured as commissure clasps or clamps 62. Adjacent side portions of the leaflets are arranged in pairs to form a number of leaflet commissures 64. In the illustrated configuration, the prosthetic valve includes a commissure clamp 62 positioned at each commissure 64 and configured to grasp two adjacent side portions of the leaflets 20 adjacent the commissure at spaced locations radially inward of the frame 12.

[0052] 1, the prosthetic valve 10 may include a number of docking or retention mechanisms configured as leaflet clamps 66. In the illustrated embodiment, the leaflet clamps 66 may be disposed on a radially outer surface of the main body 13 of the frame 12 and configured to clamp, grasp, or grab the native leaflets of the heart valve in which the prosthetic heart valve 10 is implanted such that the prosthetic heart valve is retained in the annulus after deployment. In certain embodiments, each leaflet clamp 66 may include a first end portion 90 coupled to the main body 13 (e.g., at the outflow end 18) and a second end portion 92. In some embodiments, the second end portion 92 may be a free end portion that is not directly connected to the main body 13 and may be movable (e.g., movable radially inward and outward) relative to the main body of the frame as the frame expands and / or contracts.

[0053] In the illustrated embodiment, the prosthetic valve 10 includes three clamps 66, although a greater or lesser number can be used. The clamps 66 are desirably, but not necessarily, equally spaced angularly around the periphery of the main body of the frame. If 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 positioned to clamp one of the native leaflets. If 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 positioned to clamp one of the native leaflets. In other embodiments, the prosthetic valve 10 may have a number of clamps 66 that is not equal to the number of native 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 on a single native leaflet.

[0054] In the illustrated 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 a respective first end portion 70, a central portion 72, and a second end portion 74. The first end portions 70 may be coupled to the main body 13 of the frame 12. More specifically, in certain embodiments, the first end portions 70 of the strut members 68 may be pivotally coupled (e.g., by pivot joint 26) to the adjacent apex 24 at the outflow end 18 of the frame. The second end portions 74 of the strut members 68 of each clamp 66 may be pivotally coupled to one another by pivot joint 94. In this manner, the leaflet clamps 66 may be movable between an expanded configuration ( FIG. 1 ) and a folded configuration (shown in dashed lines in FIG. 5 ) that correspond to the expanded and folded configurations of the frame 12.

[0055] For example, when the prosthetic valve 10 is in the expanded configuration, the leaflet clamps 66 are also in the expanded configuration and the first end portions 70 of the strut members 68 are circumferentially spaced apart from one another about the frame 12 such that the strut members 68 form a V-shape. In the illustrated embodiment, the openings of the V are oriented toward the outflow end of the frame. When the prosthetic valve 10 is moved to the folded configuration, the leaflet clamps 66 may also move to the folded configuration. For example, the first end portions 70 of the strut members 68 may pivot about the pivot joint 26 such that the first end portions 70 move closer together as the frame 12 is radially folded into the configuration shown in FIG. 5. The strut members 68 of the leaflet clamps 66 may also form a V-shape when the leaflet clamps are in the folded configuration, as shown in dashed lines in FIG. 5, but the first end portions 70 of the strut members are located closer together than when they are in the expanded configuration.

[0056] In an embodiment, the main body 13 of the frame 12 may be configured to have 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" means that the central portion 80 of the main body 13 of the frame 12 is offset radially outward from the inflow end 16 and the outflow end 18 relative to the longitudinal axis 78 of the main body of the frame 12, such that the diameter of the central portion of the main body is greater than the diameter of the inflow end and the outflow end of the main body. As used herein, the term "hourglass-shaped profile" means that the central portion 80 of the main body 13 is offset radially 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 main body is less than the diameter of the inflow end and the outflow end of the main body.

[0057] For example, Figures 6 and 7 show a set of strut members 22 (e.g., outer strut member 22B) of another embodiment of frame 12 in which the struts include seven rounded segments 40 (including end portions 41 and 42) and corresponding openings 28. Frame 12 is shown without leaflet clamps 66 for illustrative purposes. In an embodiment, strut members 22 may be cut (e.g., laser cut) from a tube, whereby the strut members are curved and have a radius corresponding to the radius of the tube from which the struts were cut. Thus, main body 13 has a "natural" diameter D1 corresponding to the diameter of the tube from which the strut members 22 were cut. In other embodiments, strut members 22 may be cut from sheet stock and bent to the desired curvature. In an embodiment, strut members 68 of leaflet clamps 66 may also be cut from one or more tubes, whereby the strut members are curved to the natural diameter of the tube from which the struts were cut. The natural diameter of the strut member 68 may be greater than, the same as, or less than the natural diameter D1 of the strut member 22, depending on the particular configuration.

[0058] When the prosthetic valve 10 is crimped into a radially folded configuration that is smaller than the natural diameter D1 of the main body of the frame, the central portion 76 of the strut members 22 may tend to bow radially outward, such that the main body 13 of the frame 12 has a barrel-shaped profile, as shown in FIG. 8. More specifically, when the diameter of the main body 13 is reduced, the first end portion 41 and the second end portion 42 may be positioned radially inward of the central portion 76 of the strut members 22, such that the first end portion 41 and the second end portion 42 are located closer to the longitudinal axis 78 of the frame than the central portion 76 of the strut members. Thus, the diameter D2 of the inflow end 16 of the main body 13 and the diameter D4 of the outflow end 18 of the main body can be smaller than the diameter D3 of the central portion 80 of the main body. In other words, the first end portion 41 and the second end portion 42 of the strut member 22 may be located radially inward of the central portion 76, whereby the concave side of the strut member is oriented toward the axis 78 when the diameter of the main body of the frame 12 is reduced below its natural diameter D1. The convex side of the strut member may be oriented away from the axis 78 when the diameter of the main body of the frame 12 is reduced below its natural diameter D1.

[0059] Conversely, when the prosthetic valve 10 is expanded to the expanded configuration, the main body 13 may be expanded beyond its natural diameter D1, such that the frame has an hourglass-shaped profile, as shown in FIG. 9. Referring to FIG. 9, the first and second end portions 41, 42 of the strut members 22 may be positioned radially outward of the central portion 76 of the strut members 22, such that the first and second end portions 41, 42 are located further away from the longitudinal axis 78 of the frame than the central portion 76 of the strut members. In this manner, the diameter D5 of the inflow end 16 of the main body 13 and the diameter D7 of the outflow end 18 of the main body may be smaller than the diameter D6 of the central portion 80 of the main body. In other words, when the diameter of the main body 13 is expanded beyond its natural diameter D1, the concave side of the strut members 22 is still oriented toward the axis 78, but the first and second end portions 41, 42 of the strut members 22 may be located radially outward of the central portion 76.

[0060] The fully assembled frame 12, including both the inner set of strut members 22A and the outer set of strut members 22B, may exhibit shapes as previously described when in the collapsed and expanded configurations, although the degree of barrel and hourglass shaped profiles achieved may vary depending on the constraints imposed by the joints 26 and the counter helicity of the inner set of strut members 22A and the outer set of strut members 22B. In one representative embodiment, the natural diameter D1 of the main body of the frame may be 13mm to 16mm. Thus, when the frame is crimped into the collapsed configuration, the diameter D3 of the central portion 80 of the main body 13 may be 6mm. When expanded to a functional size, the main body 13 may expand beyond its natural diameter to achieve an hourglass shape. In the previously described embodiment, the diameter D6 of the central portion 80 of the main body 13 may be 24mm to 26mm in its functional size. As shown in Figures 8 and 9, the length dimension of frame 12 (eg, in the direction of axis 78) may also shorten as the frame expands.

[0061] Variation in the radial position of the inflow end 16 and outflow end 18 of the main body of the frame 12 relative to the central portion 80 may be utilized to move or actuate the leaflet clamp 66 between open and closed positions. For example, FIG. 10 illustrates the frame 12 in a partially radially folded configuration within a native heart valve 86, with the main body of the frame having a barrel-shaped profile. As seen in FIGS. 6-9 above, only one set of strut members 22 (e.g., outer strut members 22B) are shown for ease of illustration, but in practice the frame may include both the inner and outer strut members shown in FIG. 1. In the position illustrated in FIG. 10, a first end portion 70 of the strut member 68 of the leaflet clamp 66 is coupled to the outflow end 18 of the main body 13, such that a second end portion 74 of the strut member 68 may be located radially outward of the first end portion 70. In this manner, the leaflet clamps 66 may define respective leaflet receiving areas 82 between the strut members 68 and the main body 13 of the frame 12. The leaflet receiving areas 82 may be configured to receive the leaflets 88 of the native heart valve 86 during implantation. The strut members 68 may also be bent or curved such that a concave side of the leaflet clamps 66 is oriented radially inward toward the central axis 78 and a convex side of the leaflet clamps is oriented radially outward, away from the central axis.

[0062] Conversely, when the prosthetic valve 10 is expanded to its functional size, the main body 13 of the frame 12 may assume the hourglass-shaped profile shown in FIG. 11. As previously discussed, as the frame 12 expands, the strut members 22 may bend or curve such that the first and second end portions 41, 42 (FIG. 9) of the strut members 22 are positioned radially outward of the central portion 76. This may allow the leaflet clamps 66 to be moved (e.g., by pivoting) to a closed position in which the first end portion 70 of the strut member 68 is located substantially the same radial distance from the axis 78 as or radially outward of the second end portion 74. In the closed position, the second end portion 74 may be adjacent to or in contact with the main body 13 of the frame 12. In this manner, the leaflet clamp 66 can clamp, grip, or grasp the native leaflets 88 of the heart valve 86 against the outer strut members 22 B of the frame 12 and the inner surface of the clamp 66 .

[0063] As shown in Figure 11, in the radially expanded configuration of the frame with the clamp in the closed position, the strut members 68 of the clamp may be slightly bent to conform to the shape of the main body of the frame, such that the first end portions 70 and second end portions 74 are located radially outward of a central portion of the strut members 68. Stated another way, the recesses of the strut members 68 may be reversed compared to the open position shown in Figure 10, 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 main body and the central axis.

[0064] The strut members 22 and / or strut members 68 may be made from any of a variety of biocompatible materials. For example, in certain embodiments, the strut members 22 and / or strut members 68 may be made from any of a variety of metal alloys, including nickel titanium alloys, such as Nitinol, or stainless steel, or the like.

[0065] The disclosed embodiments of the prosthetic valve may be radially folded and delivered percutaneously to the heart using any of a variety of delivery systems. For example, FIG. 12 illustrates a representative example of a delivery assembly 100 configured for use with the prosthetic valve 10 of FIGS. 1-11 and described in detail in U.S. Pat. No. 6,399,366. The delivery assembly 100 may include a handle 102, an elongated shaft 104 extending distally from the handle 102, and a plurality of first actuating members 106 (e.g., in the form of positioning tubes) extending distally outwardly from a distal end 108 of the shaft 104 through the shaft. The first actuating members 106 may be coupled to respective expansion units 54 of the valve frame 12.

[0066] The delivery assembly 100 may include a second actuating member (not shown) extending coaxially through the first actuating member and connected to the respective inner member 56. To effect radial expansion of the prosthetic valve, the first actuating member 106 is actuated to apply a distally directed force to the frame 12 and / or the second actuating member is actuated to apply a proximally directed force to the inner member 56. To effect radial compression of the prosthetic valve, the first actuating member 106 is actuated to apply a proximally directed force to the frame 12 and / or the second actuating member is actuated to apply a distally directed force to the inner member 56.

[0067] Initially, the prosthetic valve 10 can be in a radially folded configuration within a sheath 110 on the shaft 104. The sheath 110 holds the clamp 66 against an outer surface of the frame 12 during delivery of the prosthetic valve. Once the distal end of the delivery instrument has been advanced through the patient's vasculature to the treatment site (e.g., in the ascending aorta), the prosthetic valve 10 can be advanced from the sheath 110, for example, by using a rotatable actuator 112 on the handle 102. The clamps desirably have sufficient elasticity such that, once the prosthetic valve is deployed from the sheath, the clamps 66 can automatically self-expand away from the frame 12 to their open position shown in FIG. 10. The prosthetic valve 10 can then be positioned at the treatment site, expanded, and deployed using a release assembly generally indicated at 114. For example, returning to FIGS. 10 and 11, the prosthetic valve 10 can be positioned within the annulus 84 of a native heart valve 86 (e.g., the aortic valve) using the delivery assembly 100. Once the surgeon has determined that the native leaflets 88 are properly positioned within the leaflet receiving area 82, the prosthetic valve 10 may be expanded using the delivery assembly 100, whereby the leaflet clamps 66 move from the open position shown in FIG. 10 to the closed position shown in FIG. 11 to clamp the leaflets 88 against the frame 12.

[0068] In alternative embodiments, the leaflet clamp 66 may comprise a single member instead of two strut members 68 connected together. For example, in an embodiment, the leaflet clamp 66 may comprise a single strut member curved into a U-shape or V-shape similar to the leaflet clamp 66. Such a strut member may be made, for example, from any of a variety of shape memory alloys, whereby the strut member may be crimped and spring back to its functional shape upon expansion of the frame. In a further configuration, the leaflet clamp 66 may comprise a single straight strut member similar to the strut member 68, configured to move with the frame 12 between open and closed positions. In an embodiment, the leaflet clamp 66 may also include any of a variety of atraumatic coverings, such as woven or nonwoven fabrics, any of a variety of electrospun coatings, etc., such as those described below with reference to FIG. 17.

[0069] The leaflet clamp embodiments described herein may provide significant advantages over known prosthetic valve docking mechanisms. For example, because the leaflet clamp is part of the frame, a separate docking member and associated delivery instrument are not required. Furthermore, because the leaflet clamp is actuated between open and closed positions by movement of the frame between contracted and expanded configurations, the leaflet clamp can be easily reopened and the prosthetic valve repositioned until the surgeon is satisfied with the placement of the prosthetic valve. A related advantage of a mechanically expandable frame is that no balloon is required to expand the frame to its functional size, and thus there is no occlusion of blood flow during valve expansion. Also, because the leaflet clamp is actuated by prosthetic valve movement rather than self-expansion, the leaflet clamp does not need to be made from a superelastic or shape memory material. Instead, the strut members forming the clamp can be made from a relatively strong and / or stiff material, such as stainless steel or cobalt chromium alloy. In use, the strut members of the clamps deform within their elastic range as the frame is radially expanded and collapsed to move the clamps between their open and closed positions.

[0070] Additionally, although the illustrated configuration is adapted for implantation in an aortic valve, the frame and leaflet clamp may be configured for implantation in a mitral and / or tricuspid valve. For example, by reversing the orientation of the leaflet clamp 66 such that the first end portion 70 of the strut member 68 is coupled to the apex 24 at the lower end 16 of the frame (e.g., the outflow end of the frame when implanted in the mitral position), the leaflet clamp may be configured for use in the mitral and / or tricuspid valve.

[0071] 13-15 show the frame 12 in various expanded states, including both the inner and outer struts 22A, 22B, and the leaflet clamp 66. FIG. 13 shows the frame 12 at its natural diameter D1. Referring to a representative outer strut member 22B(1) for illustrative purposes, in the illustrated configuration, the strut member may include seven rounded intermediate segments or portions 40. The intermediate portions 40 may be part of seven corresponding hinges or joints 26A-26G that interconnect the outer strut member 22B(1) with the inner strut member 22A. A first end portion 70 of the strut 68 may be connected to the joint 26G at the outflow end 18 of the frame. At its natural diameter shown in FIG. 13, the strut 68 of the leaflet clamp 66 may lie parallel to and / or contact the outer strut member 22B of the frame.

[0072] FIG. 14 shows the frame 12 crimped into a folded configuration for delivery. In the folded configuration, both the inner and outer struts 22A, 22B may bend radially inward at the end portions of the frame. For example, the struts 22A and 22B may bend radially inward from about the location of the joint 26B at the inflow end 16 of the frame in an upstream direction toward the joint 26A. Similarly, the struts 22A and 22B may bend radially inward at both ends from about the joint 26F 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 height of the joint 26A may have a diameter D2, and the outflow end of the frame at the height of the joint 26G may have a diameter D4, which may be approximately equal to the diameter D2. Both diameters D2 and D4 may be less than the diameter D3 of the central portion 80 of the frame. For example, in an embodiment, frame 12 may have a diameter D3 from about the height of joint 26B to about the height of joint 26F, such that the frame has a barrel-shaped profile. Because struts 22A and 22B curve radially inward from joint 26F, struts 68 of leaflet clamp 66, which are coupled to the frame at joint 26G, may be angled away from the frame in the open position.

[0073] FIG. 15 shows frame 12 expanded to an expanded configuration. Frame 12 may have an hourglass-shaped profile with joints 26A and 26G disposed radially outward of joints 26B-26F therebetween. In this configuration, the frame may have a diameter D5 at joint 26A at inflow end 16 and a diameter D7 at joint 26G at outflow end 18. Central portion 80 may have a minimum diameter D6 located approximately between joints 26C and 26D. As 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 may be angled inward toward the frame. This allows leaflet clamp 66 to clamp the leaflets of the native heart valve against the exterior of the frame as previously described.

[0074] In other embodiments, strut members 22A and / or 22B may curve radially inward at locations other than joints 26B and 26F. For example, in other embodiments, strut members 22A and / or 22B may curve radially inward at joints 26C and 26E. In yet other embodiments, frame 12 may be configured such that outflow end 18 curves radially inward in a collapsed configuration and radially outward in an expanded configuration to actuate the leaflet clamp, with the struts at inflow end 16 exhibiting little or no curvature or remaining parallel.

[0075] 16 illustrates another embodiment of the frame 12 in an expanded configuration in which the strut members 68 of the leaflet clamps are configured to curve 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 may be bent or curved such that a concave side of the leaflet clamps 66 is oriented radially, away from the longitudinal axis of the frame, and a convex side of the leaflet clamps is adjacent or disposed against the outer strut members 22B.

[0076] FIG. 17 shows a frame 12 including a cover 71 disposed over the strut members 68 of the leaflet clamps 66. The cover 71 may comprise a tubular body in which the struts 68 may be received. In the illustrated embodiment, the cover 71 comprises a first tubular portion 73 and a second tubular portion 75 that communicate with a common third tubular portion 77, whereby the cover corresponds to the V-shape of the leaflet clamps 66. In other embodiments, the cover 71 may comprise a liner with a single lumen or opening configured to receive both struts of the leaflet clamps 66, or separate liner members configured to receive the individual struts 68 of each leaflet clamp. The cover may comprise a woven or nonwoven fabric, a knitted fabric, and / or may comprise a polymer layer, such as a dip-coated silicone layer or sleeve, or an electrospun expanded polytetrafluoroethylene (ePTFE) layer. The cover may also comprise natural tissue. As previously mentioned, the covering 71 may provide cushioning to protect the native valve leaflets clamped between the leaflet clamp 66 and the frame 12 and / or to reduce the risk of damage to surrounding tissue. The covering 71 may be configured to move the leaflet clamp 66 between the open and closed positions as the frame expands and collapses. Such coverings may be applied to the frame struts 22 and / or around the frame as a whole. Exemplary frame coverings that may be used in combination with the frames described herein can be found in U.S. Pat. No. 6,393,326 and U.S. Pat. No. 6,393,326.

[0077] Explanation of terms For the purposes of this description, certain aspects, advantages, and novel features of the disclosed embodiments are described herein. The disclosed methods, apparatus, and systems should not be interpreted as limiting in any way. Instead, the disclosure is directed to all novel and non-obvious features and aspects of the various disclosed embodiments, both alone and in various combinations and subcombinations with each other. The methods, apparatus, and systems are not limited to any particular aspect or feature or combination thereof, and the disclosed embodiments do not require that any one or more particular advantages exist or problems be solved.

[0078] Although some operations of the disclosed embodiments have been described in a particular order for convenience of presentation, it should be understood that this description style includes rearrangements, unless a particular order is required by specific language described below. For example, operations described sequentially may in some cases be rearranged or performed simultaneously. Furthermore, for simplicity, the accompanying drawings may not show various ways in which the disclosed methods may be used with other methods. Furthermore, the description may use terms such as "provide" or "achieve" to describe the disclosed methods. These terms are high-level abstractions of the actual operations that are performed. The actual operations that correspond to these terms may vary depending on the particular embodiment, and are readily discernible by those skilled in the art.

[0079] 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. Additionally, the term "includes" means "comprises." Additionally, the terms "coupled" and "associated" generally mean electrically, electromagnetically, and / or physically (e.g., mechanically or chemically) coupled or linked and do not exclude the presence of intermediate elements between coupled or associated items, unless specifically stated to the contrary.

[0080] In the context of this application, the terms "lower" and "upper" are used interchangeably with the terms "inflow" and "outflow," respectively. Thus, for example, the lower end of a valve is its inflow end and the upper end of a valve is its outflow end.

[0081] As used herein, the term "proximal" refers to a location, direction, or portion of a device that is closer to the user and away from the implantation site. As used herein, the term "distal" refers to a location, direction, or portion of a device that is away from the user and closer to the implantation site. Thus, for example, proximal movement of a device is movement of the device toward the user and distal movement of a device is movement of the device away from the user. The terms "longitudinal" and "axial" refer to axes extending in the proximal and distal directions, unless expressly stated otherwise.

[0082] Unless otherwise indicated, all numbers expressing dimensions, quantities of components, angles, molecular weights, percentages, temperatures, forces, times, etc., as used in the specification or claims are understood to be modified by the term "about". Thus, unless otherwise indicated, implicitly or explicitly, the numerical parameters described are approximations that may be influenced by the desired properties sought and / or the detection limits of testing conditions / methods well known to those skilled in the art. In directly and explicitly identifying the embodiments from the prior art discussed, the numbers of the embodiments are not approximates unless the word "about" is described. Moreover, not all alternatives listed herein are necessarily equivalent.

[0083] In view of the many possible embodiments to which the principles of the disclosed technology may be applied, it is to be recognized that the illustrated embodiments are merely preferred examples and should not be understood as limiting the scope of the disclosure. Rather, the scope of the disclosure is at least as broad as the following claims. Accordingly, we claim all that comes within the scope and spirit of those claims. [Explanation of symbols]

[0084] 10 Artificial Heart Valves 12 Frames 13 Annular main body 14 Leaflet structure 16 Inlet end 18 Outflow end 20 leaflets 22 Support member 22A First set of support members 22B Second set of support members 24 Vertex 26 Joint 26A~G Joint 28 Opening 30 Fastener 32 Spacer 34 Counterbore 36 Head part 38 Linear Segments 40 Middle Segment 41 First end portion 42 Second end portion 44 Axis 46a, 46b Longitudinal edges 48 Curved Edges 50 Open Cells 52 Gap 54 Column members 56 Inner member 58 Outer member 62 Commissure Clamp 64 commissure 66 Leaflet Clamp 68 Pillar 70 First end portion 71 Cover 72 Center part 73 First tubular portion 74 Second end portion 75 Second tubular section 76 Center part 77 Third tubular section 78 Longitudinal Axis 80 center part 82 Leaflet Receptive Area 84 Valve Annulus 86 Native Heart Valves 88 Autologous leaflets 90 First end portion 92 Second end portion 94 Pivot Joint 100 delivery assembly 102 Handle 104 Shaft 106 First operating member 108 Distal end 110 Sheath 112 Actuator 114 Release assembly

Claims

1. 1. A frame for a prosthetic heart valve, comprising: a plurality of strut members arranged to form an annular main body of the frame and connected to one another by a plurality of pivot joints, the main body of the frame being radially foldable to a folded configuration and radially expandable to an expanded configuration, the main body of the frame having an inflow end and an outflow end; a plurality of leaflet clamps disposed on an exterior of the main body of the frame and coupled to the strut members, the plurality of leaflet clamps movable between an open position corresponding to the collapsed configuration of the main body of the frame and a closed position corresponding to the expanded configuration of the main body of the frame; movement of the main body of the frame between the collapsed and expanded configurations causes corresponding movement of the leaflet clamps between the open and closed positions; When the frame is in the folded configuration, central portions of the support members are offset radially outward from the inflow and outflow ends of each of the support members relative to a longitudinal axis of the frame, whereby the main body of the frame has a barrel-shaped profile.

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

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

4. the strut members each having an inflow end portion located at the inflow end of the main body of the frame, an outflow end portion located at the outflow end of the main body of the frame, and a respective central portion between the inflow end portion and the outflow end portion; 2. The frame of claim 1, wherein when the frame is in the expanded configuration, the central portions of the strut members are offset radially inwardly from the inflow end portions and from the outflow end portions of the strut members relative to a longitudinal axis of the frame, whereby the main body of the frame has an hourglass-shaped profile.

5. Each of the strut members of the leaflet clamp includes a first end portion and a second end portion; The frame of claim 1 , wherein the second end portions of the strut members of the leaflet clamp are spaced radially outward from the main body of the frame when the leaflet clamp is in the open position.

6. The frame of claim 5 , wherein the second end portions of the strut members of each leaflet clamp are connected to one another such that the leaflet clamps are V-shaped when the frame is in the expanded configuration.

7. The frame of claim 5 , wherein the first end portion of the strut member of the leaflet clamp is connected to an apex of the outflow end of the main body of the frame.

8. A frame according to claim 1; a leaflet structure disposed at least partially within the frame.

9. The frame of claim 1 , wherein the plurality of leaflet clamps comprises a cover.

10. The frame of claim 1 , wherein each of the leaflet clamps comprises a pair of strut members pivotally connected to the strut members of the main body of the frame.

Images