Mechanically expandable heart valve

Abstract

To provide Improved implant frame designs and methods for assembly.SOLUTION: A prosthetic valve 14 can comprise a radially expandable and compressible frame 22, which can include multiple struts 32 which are pivotally joined together without requiring individual rivets. In some embodiments, the struts are interwoven, and can be joined using integral hinges formed in the struts, such as by performing alternate cuts on the struts, bending the struts to form stopper tabs adjacent to joints and / or drilling holes in the struts to facilitate interconnecting struts at joints.SELECTED DRAWING: Figure 2

Description

Technical Field

[0001] The present disclosure relates to implantable mechanically expandable artificial devices, such as artificial heart valves, and to methods and assemblies for providing a foldable frame for such artificial devices and including the same.

Background Art

[0002] Dysfunctions within the human heart, such as those resulting from valvular disease, often require repair of the native valve or replacement of the native valve with an artificial valve. Known repair devices (e.g., stents) and artificial valves exist, as do a plurality of known methods for implanting these devices and valves within a human. In one known technique, artificial devices are configured to be implanted via a minimally invasive procedure by a catheter method. For example, a foldable transcatheter artificial heart valve can be crimped into a compressed state and introduced percutaneously over a catheter in the compressed state, and expanded to a functional size at a desired location by mechanical expansion or by using a self-expanding frame or stent. However, current frame assembly designs often require a manufacturing process that involves handling and assembling many small parts. There is a need for improved implant frame designs and methods for assembly. Such a frame assembly would preferably provide one or more of the following advantages over current approaches: minimizing the number of individual parts required, maintaining flexibility for movement within a patient, folding into a low-profile to minimize the catheter size required during introduction into a patient, and reducing the risk of rivet embolization.

Prior Art Documents

Patent Documents

[0003] [Patent Document 1] U.S. Patent No. 6,730,118 [Patent Document 2] U.S. Patent No. 7,393,360 [Patent Document 3] U.S. Patent No. 7,510,575 [Patent Document 4] U.S. Patent No. 7,993,394 [Patent Document 5] U.S. Patent No. 8,652,202 [Patent Document 6] Application No. 15 / 831,197 [Patent Document 7] U.S. Provisional Application No. 62 / 506,430 [Patent Document 8] U.S. Provisional Application No. 62 / 614,299 [Patent Document 9] U.S. Application No. 15 / 978,459 [Summary of the Invention] [Problems to be Solved by the Invention]

[0004] Embodiments of improved implantable medical devices, such as embodiments of artificial heart valves, are disclosed herein, and similarly, methods for providing such devices and assemblies are disclosed herein. [Means for Solving the Problems]

[0005] In one representative embodiment, a method of assembling an implantable medical device includes providing a plurality of struts, each strut including a length and a plurality of apertures spaced from one another along the length. The method can further include providing a plurality of strut connectors, the plurality of strut connectors including an elongate support member and a plurality of protrusions spaced from one another along the support member. The method can further include connecting the struts to one another by the strut connectors to form an annular frame, with the protrusions of each strut connector extending through respective apertures of one of the struts and into respective apertures of one or more other struts to form a plurality of pivot joints between the struts.

[0006] In some embodiments, the plurality of struts include a first set of inner struts and a second set of outer struts, the inner struts being connected to the outer struts by strut connectors.

[0007] In some embodiments, the strut connectors are disposed against respective outer struts, each strut connector including at least first and second protrusions, the first and second protrusions extending through apertures of the same outer strut and into apertures of different inner struts.

[0008] In some embodiments, the strut connectors are disposed against respective inner struts, each strut connector including at least first and second protrusions, the first and second protrusions extending through apertures of the same inner strut and into apertures of different outer struts.

[0009] In some embodiments, the method further includes attaching a valve member including a plurality of valve leaflets inside the annular frame.

[0010] In some embodiments, the strut connectors are formed using electrochemical machining.

[0011] In some embodiments, the strut connectors are formed using laser machining.

[0012] In another exemplary embodiment, an implantable medical device includes a first set of a plurality of first struts extending in a first direction and a second set of a plurality of second struts extending in a second direction, the first struts being intertwined with the second struts to form an annular frame, the annular frame being radially compressible and expandable. Each first strut may be pivotally connected to at least one second strut.

[0013] In some embodiments, each first strut can include a plurality of protrusions spaced apart from each other along the length of the first strut, each second strut can include a plurality of apertures extending along the length of the second strut, and the protrusions of the first strut extend into respective apertures of the second strut.

[0014] In some embodiments, each first strut has at least one protrusion extending radially inwardly into an aperture of an adjacent second strut and at least one protrusion extending radially outwardly into an aperture of an adjacent second strut.

[0015] In some embodiments, the protrusions are integrally formed on the first struts.

[0016] In some embodiments, each first strut passes radially outside of at least one second strut and also passes radially inside of at least one second strut.

[0017] In some embodiments, the medical device may further include a valve member, the valve member may include a plurality of valve tips mounted inside an annular frame.

[0018] In another exemplary embodiment, a method of assembling a frame for an implantable medical device includes providing a plurality of individual struts including a first set of a plurality of first struts and a second set of a plurality of second struts. The method may further include weaving the first struts with the second struts to form an annular frame.

[0019] In some embodiments, the individual struts are curved prior to the weaving act.

[0020] In some embodiments, the individual struts have a radius of curvature substantially the same as the radius of curvature of the annular frame formed by the struts prior to the weaving act.

[0021] In some embodiments, the individual struts are laser cut from a metal tube.

[0022] In some embodiments, each of the plurality of first struts is formed with a plurality of radially extending protrusions, and each of the plurality of second struts is formed with a plurality of apertures.

[0023] In some embodiments, the weaving step includes connecting the first struts to the second struts by extending each of the plurality of protrusions through one of each of the plurality of apertures at the junctions between the first struts and the second struts.

[0024] In some embodiments, the connecting step includes pivotally connecting each of the first struts to the plurality of second struts.

[0025] In some embodiments, the plurality of radially extending protrusions are formed by a plurality of protrusions extending radially inward and a plurality of protrusions extending radially outward.

[0026] In some embodiments, the method further includes mounting a first set of a plurality of struts at a first assembly angle, each of the struts in the first set of struts including a plurality of radially extending protrusions, the plurality of radially extending protrusions including a central protrusion with at least two ears, the at least two ears extending outward from the central protrusion in a plane parallel to the strut formed therein. The method can further include mounting a second set of a plurality of struts on the first set of struts at a second assembly angle that forms a relative assembly angle between the first assembly angle and the second assembly angle. Each of the struts in the second set of struts includes a plurality of apertures, each aperture including a central opening corresponding to the central protrusion and an oval side opening corresponding to the at least two ears. In this embodiment, the step of mounting forms a frame.

[0027] In certain embodiments, the method can further include crimping the frame and rotating at least two ears on the first set of struts away from corresponding oval side openings in the second set of struts. The method can further include securing a plurality of mechanical lockers to the frame and limiting relative movement between the first set of struts and the second set of struts to a range of relative angles that do not include a relative assembly angle.

[0028] In another representative embodiment, the implantable medical device includes an annular frame that is radially expandable and compressible and includes a plurality of interconnected struts, the plurality of struts including a first set of a plurality of first struts and a second set of a plurality of second struts, the first struts overlapping adjacent second struts at joints, and expansion or compression of the annular frame pivoting the first struts relative to the second struts at the joints. Each of the first struts can include a plurality of pairs of radially extending first stopper tabs spaced from each other along the length of the first strut, and each of the second struts can include a plurality of pairs of radially extending second stopper tabs spaced from each other along the length of the second strut.

[0029] In certain embodiments, the first stopper tabs of each pair of tabs along the first strut extend to the opposite side portions of the adjacent second struts at the joints and can engage the second stopper tabs of the adjacent second struts when the first struts pivot relative to the second struts.

[0030] In some embodiments, the first stopper tabs extend radially inwardly and the second stopper tabs extend radially outwardly.

[0031] In another representative embodiment, the implantable medical device is a radially expandable and compressible annular frame including a plurality of interconnected struts, the plurality of struts including a first set of a plurality of first struts and a second set of a plurality of second struts, the first struts overlapping adjacent second struts at joints, and expansion or compression of the annular frame pivoting the first struts relative to the second struts at the joints. Each of the first struts can include a plurality of apertures spaced from each other along the length of the first strut, and each of the second struts can include a plurality of apertures spaced from each other along the length of the second strut. The device can further include a plurality of rivets, each rivet extending through an aperture of a first strut and an aperture of an adjacent second strut at a joint, and each rivet can further include a first flange positioned radially outside the corresponding first strut and a second flange positioned radially inside the corresponding second strut.

[0032] In some embodiments, each rivet includes a third flange intermediate the first and second flanges, the third flange being positioned radially between the first strut and the second strut at the joint.

[0033] In another exemplary embodiment, the implantable medical device is an annular frame that is radially expandable and compressible and includes a plurality of interconnected struts, the plurality of struts including a first set of a plurality of first struts and a second set of a plurality of second struts, the first struts overlapping adjacent second struts at joints, the expansion or compression of the annular frame including pivoting the first struts relative to the second struts at the joints, the frame including a plurality of hinges at the joints, the plurality of hinges extending from the first struts through corresponding non-circular apertures of the second struts at the joints.

[0034] In some embodiments, each hinge can include a cylindrical pivot portion and a locking member extending from the pivot portion, the pivot portion being rotatable within a corresponding aperture of the second strut, the locking member being sized and shaped relative to the corresponding aperture of the second strut to prevent radial separation of the first and second struts whenever the locking member is rotationally offset from the corresponding aperture in the case of radial expansion and compression of the frame.

[0035] In some embodiments, the second strut is formed with a recess surrounding the non-circular aperture, and the locking member of the hinge is disposed within the recess.

[0036] In some embodiments, the implantable medical device further includes one or more actuators, the one or more actuators being mounted on the frame and configured to radially expand and compress the frame between a radially compressed state defining a compression diameter and a radially expanded state defining an expansion diameter. In certain embodiments, each locking member is rotationally offset from a corresponding non-circular aperture in the second strut at the compression diameter, the expansion diameter, and all diameters between the compression diameter and the expansion diameter.

[0037] In some embodiments, the hinge is integrally formed on the first strut.

[0038] In some embodiments, the hinge is a component separate from the first and second struts. Each of the first struts can include a plurality of non-circular apertures, and each hinge extends through an aperture in the first strut and an adjacent aperture in the second strut at the junction.

[0039] In some embodiments, each hinge further includes a retaining member configured to be retained within a non-circular aperture on the first strut.

[0040] In some embodiments, each hinge further includes a circular base member configured to be retained within a circular recess surrounding one of the non-circular apertures on the first strut.

[0041] In some embodiments, the locking member includes a non-circular shape.

[0042] In some embodiments, the locking member includes a non-circular central protrusion with at least two ear portions, and the at least two ear portions extend outwardly from the non-circular central protrusion within a plane parallel to the strut.

[0043] In another representative embodiment, a method of assembling an implantable medical device includes providing a plurality of first struts and providing a plurality of second struts, each second strut including a plurality of non-circular apertures spaced along its length, and connecting the first and second struts to each other by inserting hinges through the non-circular apertures of the second struts to form an annular frame, each hinge having a cylindrical pivot portion disposed within a corresponding non-circular aperture and a locking member extending from one end of the pivot portion, the locking member being rotationally aligned with the corresponding non-circular aperture when the hinge is inserted into the non-circular aperture.

[0044] In some embodiments, the method further includes pivoting the first strut relative to the second strut and rotating the locking member offset from its corresponding non-circular aperture in the rotational direction, and attaching one or more actuators to the frame, the one or more actuators being configured to radially expand and compress the frame within a predetermined diameter range corresponding to a predetermined angular range between the first strut and the second strut, the locking member always being rotationally offset from the non-circular aperture within the predetermined angular range.

[0045] In some embodiments, each first strut includes a plurality of non-circular apertures spaced along its length, and the step of connecting the first and second struts further includes inserting a hinge through the non-circular apertures of the first and second struts.

[0046] In some embodiments, the hinge is integral with the first strut.

[0047] In some embodiments, the first strut is intertwined with the second strut.

[0048] In another representative embodiment, the implantable medical device includes a radially expandable and compressible annular frame including an inner frame subassembly and an outer frame subassembly. Each of the frame subassemblies can include a closed annular frame including a plurality of interconnected struts. The plurality of struts of each frame subassembly can include a first set of a plurality of first struts and a second set of a plurality of second struts, the first struts being adjacent and overlapping the second struts at joints and being rotatably connected to the second struts, and expansion or compression of the annular frame pivots the first struts relative to the second struts at the joints.

[0049] In some embodiments, each of the first struts can include either a plurality of protrusions spaced apart from each other along the length of the first strut, or a plurality of apertures spaced apart from each other along the length of the first strut, and each of the second struts can include a plurality of apertures and a plurality of protrusions spaced apart from each other along the length of the second strut. At each joint, a protrusion on the first strut can be inserted through an aperture of an adjacent second strut, or a protrusion on the second strut can be inserted through an aperture of an adjacent first strut, rotatably connecting the first strut to the second strut.

[0050] In certain embodiments, each of the inner frame subassembly and the outer frame includes at least three inner struts and three outer struts. In certain embodiments, the outer frame assembly includes six inner struts and six outer struts.

[0051] In some embodiments, the prosthetic valve leaflet assembly is positioned within the inner frame subassembly. In certain embodiments, the prosthetic valve leaflet assembly is positioned within and fixed to the inner frame subassembly without being fixed to the outer frame subassembly. In more specific embodiments, the prosthetic valve leaflet assembly is positioned such that the prosthetic valve leaflet is prevented from contacting the outer frame subassembly when the prosthetic valve leaflet opens during the cardiac cycle, while in other embodiments such contact is minimized.

[0052] In some embodiments, the skirt is positioned over the inner frame subassembly. In certain embodiments, the skirt is positioned between an inner set of struts and an outer set of struts of the inner frame subassembly. In another embodiment, the skirt is positioned outside the inner frame subassembly and disposed between the inner frame subassembly and the outer frame subassembly.

[0053] In some embodiments, one or more actuators are positioned over the frame, and the one or more actuators are configured to expand and compress the frame radially. In certain embodiments, the actuator may be configured to expand and compress the frame within a range of diameters corresponding to a range of predetermined angles between a first strut and a second strut.

[0054] In another representative embodiment, a method of assembling an implantable medical device includes assembling an inner frame subassembly including a plurality of first struts and a plurality of second struts. The method can further include forming a first closed annular inner frame subassembly by connecting the first and second struts to each other and connecting each of the plurality of first struts to at least two of the plurality of second struts. The method can further include assembling an outer frame subassembly including a plurality of third struts and a plurality of fourth struts. The method can further include forming a second closed annular outer frame subassembly by connecting the third and fourth struts to each other and connecting each of the plurality of third struts to at least two of the plurality of fourth struts. After assembling the inner frame subassembly and the outer frame subassembly, the method can further include inserting the inner frame subassembly inside the outer frame subassembly and interconnecting the two subassemblies at a plurality of joints along the struts forming a single closed annular frame assembly.

[0055] In some embodiments, the method can further include assembling a valve tip assembly on top of the inner frame subassembly. In certain embodiments, the valve tip assembly is assembled on top of the inner frame subassembly without contacting the outer frame subassembly. In some embodiments, a skirt is positioned on top of the inner frame subassembly. In certain embodiments, the skirt is positioned between an inner set of inner struts and an outer set of outer struts of the inner frame subassembly. In another particular embodiment, the skirt is positioned outside the inner frame subassembly and disposed between the inner frame subassembly and the outer frame subassembly. In another particular embodiment, the skirt is positioned inside the inner frame subassembly and positioned with the valve tip assembly.

[0056] In some embodiments, the inner frame subassembly and the outer frame subassembly are rotatably interconnected at a joint along the strut via a plurality of hinge members. The hinge members can include, for example, rivets, pins, integral protrusions, or similar mechanisms. In certain embodiments, the hinge members can pass through two or more of the inner frame subassembly, the skirt, and the outer frame subassembly. In certain embodiments, a rivet or other protrusion can pass through three or more of the prosthetic valve subassembly, the inner frame subassembly, the inner skirt, and the outer frame subassembly. In certain embodiments, the outer skirt can be attached to the outer frame subassembly.

[0057] The foregoing and other objects, features, and advantages of the present invention will become apparent from the following detailed description, which proceeds with reference to the accompanying figures.

Brief Description of the Drawings

[0058]

Figure 1

Figure 2

Figure 3A

Figure 3B

Figure 4

Figure 5

Figure 6

Figure 7

Figure 8

Figure 9

Figure 10A

Figure 10B

Figure 11

Figure 12

Figure 13

Figure 14A

Figure 14B

Figure 15A

Figure 15B

Figure 15C

Figure 16A

Figure 16B

Figure 17

Figure 18A

Figure 18B

Figure 18C

Figure 19A

Figure 19B

Figure 19C

Figure 20

Figure 21

Figure 22

Figure 23

Figure 24

Figure 25

Figure 26

Figure 27

Figure 28

Figure 29

Figure 30A

Figure 30B

Figure 30C

Figure 31A

Figure 31B

Figure 32A

Figure 32B

Figure 33

Figure 34

Figure 35A - 35B

Figure 36

Figure 37

Figure 38A

Figure 38B

Figure 39

Figure 40A

Figure 40B

Figure 40C

Figure 41

Figure 42

Figure 43

Figure 44

Figure 45

Figure 46

Figure 47

Figure 48

Figure 49

Figure 50

Figure 51

Figure 52

DETAILED DESCRIPTION OF THE INVENTION

[0059] Described herein are examples of an artificial implant delivery assembly and components thereof, which can improve a physician's ability to control the size of a mechanically expandable artificial implant, such as an artificial valve (e.g., an artificial heart valve or venous valve), a stent, or a graft, and can also facilitate separation of the artificial implant from the delivery assembly during the implantation procedure. Also, the present disclosure provides a frame for use with such an artificial implant. The frame can include struts shaped to reduce or eliminate pinching of soft components of the artificial implant (e.g., the valve leaflets of the implant) when the implant is radially compressed into a delivery configuration for delivery into a patient.

[0060] FIG. 1 shows one example of an artificial implant delivery assembly 10 that can be used with one or more of the embodiments of the present disclosure. The delivery assembly 10 can include two main components, namely an artificial heart valve 14 and a delivery device 18. The artificial valve 14 can be releasably coupled to the delivery device 18, as further described below. It should be understood that the delivery device 18 and other delivery devices disclosed herein can be used to implant artificial devices other than artificial valves, such as stents or grafts.

[0061] FIG. 2 is a side view of the artificial valve 14 shown in its implanted radially expanded configuration. It should be recognized that only one side of the artificial valve 14 is shown in the drawing, and the opposite side is similar to the portion shown. The artificial valve 14 can include an annular stent or frame 22, and a valve structure 24, and the valve structure 24 can be coupled to the frame 22. The frame 22 can have an inflow end portion 26, an intermediate portion 28, and an outflow end portion 30. The artificial valve 14 can define a longitudinal axis extending through the inflow end portion 26 and the outflow end portion 30.

[0062] Frame 22 can be made of any of a variety of suitable materials, such as, for example, stainless steel or a nickel titanium alloy (“NiTi”), such as Nitinol, or, similarly, a CoCr alloy. Frame 22 can include a plurality of interconnected lattice struts 32, which are arranged in a lattice type pattern and form a plurality of vertex portions 34 at the outflow end 30 of the artificial valve 14. Also, the struts 32 can form similar vertex portions at the inflow end of the artificial valve (which is covered by the skirt 50 in FIG. 2). The lattice struts 32 are shown as being positioned obliquely or offset at a predetermined angle with respect to the longitudinal axis of the artificial valve and radially offset from the longitudinal axis of the artificial valve. In other implementations, the lattice struts 32 can be offset by an amount different from that shown in FIG. 2, or some or all of the lattice struts 32 can be positioned parallel to the longitudinal axis of the artificial valve 14. The lattice struts 32 can include a set of inner struts 32a (extending from the upper left to the lower right of the frame in FIG. 2) and a set of outer struts 32b connected to the inner struts 32a (extending from the lower left to the upper right of the frame in FIG. 2).

[0063] The lattice struts 32 can be pivotally connected to each other. In the illustrated embodiment, for example, the end portions of the struts 32 that form the apex portions 34 at the outflow end 30 and the inflow end 26 of the frame 22 can each have an opening 36. Also, the struts 32 can be formed with an aperture 38, and the apertures 38 are spaced along their lengths between opposite ends of the struts. Each hinge can be formed at the apex portion 34 and at the location where the struts 32 overlap each other between the ends of the frame via a fastener 40, and the fastener 40 can include individual rivets or pins that extend through the apertures 36, 38. The hinge can enable the struts 32 to pivot relative to each other when the frame 22 expands or contracts, such as during the assembly, preparation, or implantation of the prosthetic valve 14. For example, the frame 22 (and thus the prosthetic valve 14) can be operated to a radially compressed or contracted configuration (see, e.g., FIGS. 6 and 7) and inserted into a patient for implantation. Once inside the body, the prosthetic valve 14 can be operated to an expanded state (see, e.g., FIGS. 2 and 4) and then released from the delivery device 18 (see, e.g., FIG. 1) as further described below.

[0064] The frame 22 can be formed using any suitable technique. Suitable techniques include forming the individual components of the frame (such as the struts 32 and the fasteners 40) separately and then mechanically assembling and connecting the individual components to form the frame 22. The struts and fasteners can be formed, for example, by laser cutting their components from a metal sheet or tube, or by electroforming (electroplating or electrodeposition) or physical vapor deposition, or by electrochemical machining and / or chemical etching.

[0065] In some embodiments, electroforming or physical vapor deposition can be used to form subcomponents of the frame 22 or the entire frame 22 by a pivotable connection between struts. In one implementation, for example, electroforming or physical vapor deposition can be used to form a strut 32 having an integral fastener 40. By inserting the integral fasteners 40 of each strut through corresponding apertures of adjacent struts, the individual struts can be assembled together to form a frame. In some embodiments, electroforming or physical vapor deposition can be used to form the entire frame into its final cylindrical or tubular shape. In the illustrated embodiment, the frame 22 is shown as generally cylindrical in shape, but other frame shapes such as, for example, conical, hourglass, or barrel shapes can also be used. In other embodiments, electroforming or physical vapor deposition can be used to form the entire frame in a flattened configuration, and then the ends of the flattened frame are connected to each other to form the final tubular shape of the frame. A frame formed from struts having integral fasteners is further described in detail below.

[0066] In other embodiments, the lattice struts 32 are pivotable or bendable relative to each other in other ways rather than being connected to each other by respective hinges (e.g., fasteners 40), allowing for radial expansion and contraction of the frame. For example, the frame 22 can be formed from a single piece of material (e.g., a metal tube) via (e.g., laser cutting, electroforming, or physical vapor deposition).

[0067] In addition to the lattice struts 32, the frame 22 can include one or more longitudinally extending support struts 42. The support struts 42 can be circumferentially spaced around the frame 22 and can be connected (including being pivotally connected) to the lattice struts 32. The support struts 42 can be positioned parallel to the longitudinal axis of the artificial valve and can be radially spaced from the longitudinal axis of the artificial valve. The support struts 42 can strengthen the rigidity of the frame 22 and can help the frame 22 maintain a uniform shape when the frame 22 expands or contracts. In some implementations, the frame 22 does not include the support struts 42. The support struts 42 can be connected to the lattice struts 32 at hinge joints formed by fasteners 40, and the fasteners 40 can extend through respective apertures in the lattice struts and the support struts.

[0068] Referring to FIGS. 3A and 3B, a spacer 46, such as a washer or a bushing, can be disposed within a joint between the lattice struts 32 or a joint (not shown) between the lattice strut 32 and the support strut 42. When the lattice struts 32 and / or the support struts 42 are pivotally connected to each other, the spacer 46 can assist the lattice struts 32 in moving relative to each other or the lattice struts 32 and the support struts 42 in moving relative to each other. Also, the spacer 46 can act to space the lattice struts 32 apart from each other or from the support struts 42. In some implementations, the frame 22 does not include the spacer 46, or the lattice struts 32 or the lattice struts 32 and the support struts 42 are spaced apart in a different manner.

[0069] In certain embodiments, the fasteners 40 do not extend radially outwardly from their respective apertures 36, 38 in the struts and can be fully contained within the apertures. As shown in FIG. 3B, for example, each of the apertures 36 in the radially outermost strut 32 can include a countersink or enlarged recessed portion 37 that is sized to receive the head portion 41 of each fastener 40 (e.g., a rivet). The head portion 41 can be fully received within the countersink 37 and does not extend radially outwardly from the countersink, and for example, the head portion 41 can be flush with the outer surface of the strut 32. Similarly, the aperture 38 can also be formed with a countersink to receive the head portion 41 of the fastener. In this way, the fasteners 40 do not increase or contribute to the overall crimp profile of the prosthetic valve and do not interfere with or unduly stress the delivery sheath of the valve (e.g., sheath 82 in FIG. 1).

[0070] Returning to FIG. 2, the prosthetic valve 14 can include a valve structure 24 for conditioning the flow of blood through the prosthetic valve. The valve structure 24 can include, for example, a valve leaflet assembly 48 that includes one or more valve leaflets made of a flexible material. The valve leaflets can be configured to move between an open position that permits blood flow through the valve in a first direction and a closed position that blocks blood flow through the prosthetic valve in a second direction opposite the first direction. The valve leaflets of the valve leaflet assembly 48 can be made, in whole or in part, from a biological material (e.g., a surrounding tissue, such as bovine or equine pericardium), a biocompatible synthetic material, or other such materials, such as those described in U.S. Patent No. 6,730,118.

[0071] In addition, the prosthetic valve can include an annular skirt or sealing member 50, which can be fixed to the outer surface of the inflow end portion 26 of the frame 22, for example, by suture 56 adjacent to the inflow end portion 26 of the frame 22. The inflow end portion of the valve tip assembly 48 can be fixed to the frame 22 and / or the skirt 50, for example, using suture 56. The skirt 50 helps establish a seal with natural tissue at the implantation site and prevents or minimizes perivalvular leakage. In an alternative embodiment, the prosthetic valve can have a skirt or sealing member mounted on the inside of the frame, or can have a skirt or sealing member mounted on both the inside and outside of the frame. The skirt can be formed from any of a variety of biocompatible synthetic materials, including natural tissue (e.g., surrounding tissue), or a biocompatible fabric (e.g., polyethylene terephthalate (PET) fabric).

[0072] Further details regarding transcatheter prosthetic heart valves, including the manner in which the valve structure 24 can be coupled to the frame 22 of the prosthetic valve 14, can be found, for example, in U.S. Patent Nos. 6,730,118, 7,393,360, 7,510,575, 7,993,394, and 8,652,202.

[0073] FIG. 4 is a side view of a portion of a frame 200 that can be used with a prosthetic valve in at least certain embodiments of the present disclosure. Although only one side of the frame 200 is shown in FIG. 4, it should be appreciated that the frame 200 forms an annular structure having an opposite side that is identical to the portion shown. The frame 200 is similar to the frame 22 discussed above, but does not include the longitudinal struts 42.

[0074] Frame 200 can include a plurality of lattice struts 204, and the plurality of lattice struts 204 includes a set of inner struts 204a and a set of outer struts 204b pivotally connected to the inner struts 204a. Each of the lattice struts 204 can include a plurality of apertures 208. The apertures 208 can be used to connect the lattice struts 204 to each other using fasteners 210, such as those described above with respect to the lattice struts 32 (FIG. 2). In other implementations, the apertures 208 and fasteners 210 can be omitted. For example, the lattice struts 204 can be securely connected to each other, for example, by welding or adhesion, or by laser cutting the individual struts of the frame from a metal tube. Although not shown in FIG. 4, spacers can be included between the lattice struts 204, for example, in the middle between portions of the lattice struts 204 having the apertures 208. In a particular example, the spacers can be configured as described above with respect to the spacer 46. Similarly, if desired, the frame 200 can include a support strut (not shown) that can be similar to the support strut 42 (FIG. 2).

[0075] As best shown in the flattened view of the strut in FIG. 5, in one design that can be used with a particular embodiment of the present disclosure, each lattice strut 204 can have an offset or zigzag pattern defined by a plurality of offset linear portions or segments 218. In the illustrated embodiment, the linear segments 218 are arranged end-to-end with respect to each other, with adjacent ends interconnected by an intermediate segment 220. The strut 204 can have enlarged end portions 224, which form vertex portions at the inlet and outlet ends of the frame. Each linear segment 218 is slightly laterally offset from the adjacent linear segment 218 in a direction perpendicular to the overall length of the strut 204, providing a zigzag pattern to the strut. Each of the intermediate segment 220 and the end portion 224 can have respective apertures 208 at its geometric center for receiving the fastener 210.

[0076] Along the length of the strut 204, the amount of offset of each linear segment 218 with respect to the adjacent linear segments can be constant, such that the imaginary line 214 can pass through the apertures 208 of each intermediate segment 220 along the entire length of the strut. In an alternative embodiment, the amount of offset between two adjacent linear segments 218 can vary along the length of the strut. For example, the amount of offset between linear segments 218 adjacent to the outlet end of the frame can be greater than the amount of offset between linear segments 218 adjacent to the inlet end of the frame, or vice versa.

[0077] The linear segment 218 can include at least substantially flat or linear opposing longitudinal edges 226a, 226b, which extend between the curved or rounded edges 228 of the intermediate segment 220. In an alternative embodiment, the opposing edges 228 of the intermediate segment 220 can be substantially flat or linear edges that extend at an angle between the respective ends of the edges 226a, 226b of the linear segment 218.

[0078] As best shown in FIG. 5, the width W1 of each linear segment 218 is defined as the distance measured between the opposing edges 226a, 226b of the segment 218. In the illustrated embodiment, the width W1 is constant along the length of the strut 204. As such, each longitudinal edge 226a is laterally offset from the adjacent longitudinal edge 226a of the adjacent linear segment 218, and each longitudinal edge 226b is laterally offset from the adjacent longitudinal edge 226b of the adjacent linear segment 218. The width W2 of each intermediate segment 220 and end portion 224 can be greater than the width W1 of the linear segment 218.

[0079] In an alternative embodiment, the width W1 of each linear segment 218 can vary along the length of the strut. For example, the width W1 of the linear segment 218 adjacent to the inlet end of the frame can be larger than the width W1 of the linear segment 218 adjacent to the outlet end of the frame, or vice versa. Further, when the width W1 of the linear segment 218 varies along the length of the strut 204, the linear segment can have one longitudinal edge 226a or 226b that is collinear with the longitudinal edge of the adjacent linear segment on the same side of the strut, while the other longitudinal edge 226a, 226b is laterally offset from the longitudinal edge of the adjacent linear strut on the same side of the strut. In other words, the strut 204 can have an overall zigzag or offset pattern due to the varying width W1 of the linear segments.

[0080] The offset or zigzag pattern of the strut segments 218 helps to circumferentially space the struts 204 when the frame 200 is in a radially compressed state, as shown in FIGS. 6 and 7. As shown, the open lattice structure of the frame 200 that defines the open cells 250 between the struts 204 can be uniformly preserved when the frame 200 is fully compressed or collapsed. For example, referring to FIG. 6, the width of the cell 250 along the length of the frame 200 can vary between adjacent struts, but the gap 256 remains in the middle of the cell 250 between two adjacent pivot joints 254.

[0081] When the frame 200 is incorporated within an artificial valve (e.g., artificial valve 14), the property of the struts 204 being spaced apart (including the gap 256) can assist in protecting the soft components of the artificial valve when the frame 200 expands and contracts. For example, FIG. 7 shows an artificial valve that includes the frame 200, a skirt 266 mounted outside the frame 200, and a valve tip assembly 264 mounted inside the frame 200. Also, an inner skirt (not shown) can be mounted inside the frame. The skirt 266 and the valve tip assembly 264 can be connected to the frame 200, for example, by suture threads 270. The suture threads 270 can extend radially through the material of the skirt 266 and / or the valve tip assembly 264 and around the struts 204. The gap 256 created by the offset configuration of the struts 204 can protect the valve tip 264, the skirt 266, and / or the suture threads 270 such that they are not pinched or sheared between adjacent struts 204 when the artificial valve is radially compressed. In this way, the soft components of the artificial valve are protected against damage that can occur from contact with the metal struts of the frame.

[0082] The delivery device 18 of FIG. 1 is particularly suitable for implanting, among other things, the artificial valve 14 or any of the other artificial valves disclosed herein. However, it should be noted that any of the artificial valves disclosed herein can be implanted using other suitable delivery devices. For example, any of the artificial valves disclosed herein can be crimped onto the inflatable balloon of a conventional balloon catheter. When delivered to the implantation site, the balloon can be inflated to expand the artificial valve to its fully functional size.

[0083] Referring again to FIG. 1, the delivery device 18 can include a handle 70, an elongated shaft 72 extending distally from the handle 70, and a plurality of first actuating members 76 (also referred to as elongated positioning members), such as in the form of positioning tubes, extending distally outwardly through the shaft and from the distal end 78 of the shaft 72. A plurality of release members 106 (FIG. 9) extending through each positioning member 76, and a plurality of second actuating members 86 (also referred to as "tethers") extending through each release member 106. The positioning members 76 can be at least partially disposed radially within one or more lumens of the shaft 72 and can extend axially through one or more lumens of the shaft 72. For example, the positioning members 76 can extend through the central lumen of the shaft 72 or through separate respective lumens formed in the shaft 72.

[0084] The shaft 72 can have a distal end portion 82 that functions as a sheath for containing or receiving the prosthetic valve 14 in a radially compressed state for delivery through the patient's vasculature. In this regard, the distal end portion 82 can have a lumen sized to receive the prosthetic valve 14 in a radially compressed state. As shown in FIG. 12, the proximal end portion of the shaft 72 can extend into an axially extending bore 138 formed in the distal end portion of the handle 70. The proximal end portion of the shaft 72 can be retained within the axial bore 138 by thermally bonding the catheter 72 to the bore 138 using an adhesive, clamp, fastener, through pressure or frictional contact with the bore 138, or by some other technique or mechanism.

[0085] The positioning member 76 has a distal end portion, and the distal end portions can be releasably connected to the artificial valve 14 via respective release-and-locking units 94 (as best shown in FIG. 8). As shown in FIG. 12, the positioning member 76 can extend through the shaft 72, proximally beyond the proximal end 140 of the shaft, and into the central bore 142 of the handle 70. A lead screw 144 can be disposed in the central bore 142 of the handle 70. The proximal end of the positioning member 76 can be fixed to the lead screw 144, for example, received in a bore (not shown) of the lead screw 144, where they can be fixed by pressure or frictional contact with the bore of the lead screw 144 using an adhesive, clamp, fastener, thermal bonding, or another suitable technique or mechanism.

[0086] As shown in FIGS. 8 and 9, respective actuating members 86 can extend through the lumen of respective positioning members 76. The actuating members 86 can be connected at their distal end portions to the distal end 60 of the frame 22. For example, the distal end portions of respective actuating members 86 can be connected at the apex 34 at the distal end 60 of the frame, for example, by welding, adhesive, or mechanical fasteners. Also, respective actuating members 86 can extend through the lumen of respective locking units 94, and the locking units 94 can be connected to the frame 22, for example, at the apex 34 at the proximal end 62 of the frame. The actuating members 86 can extend proximally into and through the handle 70. The proximal end portion 88 of the actuating member 86 can be releasably held by a clamping member 182 mounted in or on the handle 70 (FIG. 12).

[0087] The actuating member 86 functions in cooperation with the positioning member 76 to apply a proximally-directed tensile force to the distal end portion 60 of the frame, and the positioning member 76 applies a distally-directed pushing force to the proximal end portion 62 of the frame to effect a radial expansion of the frame 22. In certain embodiments, the actuating member 86 can comprise a relatively flexible but relatively inelastic material that can effectively transmit the tensile force generated at the handle 70 to the distal end portion of the frame 22. For example, the actuating member 86 can comprise a wire, suture, string, or similar material. In other embodiments, the actuating member 86 can be a relatively stiffer component, such as a shaft or rod, that can transmit a proximally-directed tensile force to the frame and, likewise, can transmit a distally-directed pushing force to the frame.

[0088] The release member 106 has a distal end portion 107 and a proximal end portion 108, the distal end portion 107 extending coaxially through respective locking units 94 (FIG. 9), and the proximal end portion 108 extending into the handle 70 (FIG. 12). The proximal end portion 108 of the release member 106 can extend through a lead screw 144 and can be secured to a release knob 168 within the handle 70.

[0089] Referring to FIGS. 1 and 12, a threaded actuator nut 148 can be disposed about the lead screw 144. An internal thread (not shown) of the threaded actuator nut 148 can engage the thread 150 of the lead screw 144. The outer surface 152 of the threaded actuator nut 148 can extend through an aperture or window 154 formed in the outer surface 156 of the handle 70. The outer surface 152 of the threaded actuator nut 148 includes a texture, such as a ridge portion 158, that can assist a user in gripping and rotating the threaded actuator nut 148.

[0090] Rotation of the threaded actuator nut 148 in the first direction can axially translate the lead screw 144 distally relative to the handle 70, thereby translating the positioning member 76 distally through the lumen of the shaft 72. Rotation of the threaded actuator nut 148 in the opposite direction can translate the lead screw 144 proximally relative to the handle, thereby retracting or translating the positioning member 72 proximally through the lumen of the shaft 72.

[0091] In certain implementations, the number and spacing of the threads 150 of the lead screw 144 (and thus the mating threads of the threaded actuator nut 148), as well as the axial length of the lead screw 144, can be selected to provide a desired degree of advancement for the positioning member 76 and the release member 106. For example, the desired degree of advancement can be sufficient to enable the frame 22 (and thus the prosthetic valve 14) to be operated between a fully expanded state (such as that shown in FIGS. 2 and 8, for example) and a fully collapsed or compressed state (such as that shown in FIGS. 6 and 7, for example) (including states between the fully compressed or collapsed state and the fully expanded state).

[0092] The release-and-locking unit 94 (also referred to as the "locking unit") in the illustrated embodiment is configured to releasably connect the positioning member 76 to the frame 22 of the prosthetic valve 14 and is also configured to selectively secure the actuating member 86 to hold the prosthetic valve 14 in the implanted and expanded states. Referring to FIGS. 8-11, the locking unit 94 can generally include a cylindrical body portion 96 that can be secured to the frame 22 of the prosthetic valve 14 by a fastener 130 (e.g., a pin or rivet). The fastener 130 can extend through an aperture 132 (FIG. 11) formed in the body portion 96 and can also extend through one or more corresponding apertures 36 in the frame struts 32 that form the apex portion 34 (FIG. 8) of the frame.

[0093] The body portion 94 can include a locking mechanism, which can be in the form of a clamp 98, for example, disposed adjacent the distal end 100 of the locking unit 94 for selectively engaging the actuating member 86. The clamp 98 can include, for example, a pair of diametrically opposed jaws 102 that are biased radially inwardly toward each other (as best shown in FIG. 11). The release member 106 is disposed within the lumen of each locking unit 94 and can keep the jaws 102 of the clamp in a disengaged or unlocked state (FIG. 9) during delivery of the prosthetic valve 14. Each release member 106 can extend proximally through the respective positioning member 76 to the handle 70. As discussed above, the proximal end portion 108 of the release member can be secured to the release knob 168 in the handle (FIG. 12). Each actuating member 86 can extend proximally through the lumen of the respective release member 106 into the handle 70.

[0094] In certain embodiments, the release member 106 can be made of any suitable biocompatible metallic or polymeric material. In at least some examples, the material can be selected such that, as further described below, the release member 106 is able to move freely relative to the joe 102 during valve placement. For example, the release member 106 can be made of a lubricious or low friction material (e.g., PTFE), or can have an outer layer made of a lubricious or low friction material (e.g., PTFE).

[0095] When the release member 106 is disposed within the locking unit 94 that extends between the joes 102, the joes 102 are held in an unlocked state and are prevented from contacting the actuating member 86. In the unlocked state, the actuating member 86 and the positioning member 76 are free to move axially relative to each other and can control the radial expansion and compression of the prosthetic valve 14. When the prosthetic valve 14 is to be released from the delivery device 18, the release member 106 can be retracted proximally relative to the locking unit 94 and the positioning member 76. As shown in FIGS. 10A and 11, when the release member 106 is removed from engagement with the joe 102, the joe 102 can move to a locked or engaged state in which it engages the actuating member 86, thus fixing the actuating member 86 against further axial movement and thus maintaining the frame 22 of the prosthetic valve 14 in the desired expanded state.

[0096] Returning to FIGS. 10A and 10B, the locking unit 94 can be releasably coupled to the positioning member 76 by the release member 106. In the illustrated embodiment, for example, the distal end portion 110 of each positioning member 76 can include a connection portion 112, and the connection portion 112 can include a tab 114 and a notch 116. Each locking unit 94 can include a corresponding notch 120 configured to receive the tab 114 of the positioning member 76. Similarly, each locking unit 94 can include a tab 122 that is to be inserted into and received by the notch 116 of each positioning member 76. The tabs 114, 122 and notches 120, 116, together with the release member 106, can collectively form a releasable interlocking joint. The engagement of the tabs 114, 122 with the notches 120, 116 prevents axial separation of the positioning member 76 from the locking unit 94, while the release member 106 (which extends through the tabs 114, 122 in the locked state) prevents lateral separation of the positioning member 76 from the locking unit 94.

[0097] As shown in FIG. 10B, the tab 114 of the positioning member 76 can include an axially extending slot 128. The slot 128 can be sized to allow the tab 114 to be installed around the actuating member 86 or to allow the tab 114 to be removed from the actuating member 86 by passing the actuating member 86 through the slot 128. However, the slot 128 is preferably narrower than the diameter of the release member 106 and prevents lateral separation of the positioning member 76 from the locking unit 94 when the release member 106 extends through the tabs 114, 122 as shown in FIG. 9. As described above, the retraction of the release member 106 from the jaw 102 of the clamp 98 allows the jaw to engage the actuating member 86. Further retraction of the release member 106 until the distal end of the release member 106 is proximal to the tab 122 and the notch 116 allows the distal end portion 110 of the positioning member 76 to be separated laterally (in a direction perpendicular to the length of the locking unit and the positioning member) from the locking unit 94 as shown in FIG. 10A. When the positioning member 76 moves laterally away from the locking unit 94, the actuating member 86 can pass through the slot 128 in the tab 114.

[0098] Further, as shown in FIG. 10A, the tabs 114, 122 are formed with respective inclined cam surfaces 124, 126 that each facilitate separation of the positioning member 76 from the locking unit 94. Each cam surface 124, 126 is inclined at an angle of less than 90 degrees with respect to the longitudinal axis of the positioning member 76. Thus, applying a proximally directed force to the positioning member 76 in the direction of arrow 134 (such as by applying a pulling force to the positioning member at the handle 70, for example) slides the positioning member 76 laterally away from the locking unit 94 in the direction of arrow 136.

[0099] The locking unit 94 and / or the positioning member 76 includes a cutting mechanism and is capable of cutting a portion of the actuating member 86 that extends proximally beyond the jaw 102 of the clamp 98 after the prosthetic valve has been inflated, and the release member is retracted to operate the clamp. For example, a blade or other cutting surface may be disposed across the slot 128 such that the actuating member 86 can be cut when it passes through the slot 128 during lateral separation of the positioning member 76 away from the locking unit 94.

[0100] In another example, the locking unit 94 can include a clamping member that can include a cutting jaw (such as a sharpened or serrated jaw, etc.) positioned proximally to the jaw 102. A cutting jaw, such as the jaw 102, can be held in an open position away from the actuating member by the release member 106. When the release member 106 is retracted to disengage from engagement with the cutting jaw, the cutting jaw can flex radially inwardly against the actuating member 86, thereby cutting it in place. In a further example, after the positioning member 76 has been released from the prosthetic valve 14 and, optionally, after the delivery device 18 has been removed from the body portion, a separate cutting device can be used to cut the actuating member 86 at a desired location.

[0101] Referring again to FIGS. 1 and 12, the lead screw 144 includes an extension portion 160 that extends proximally from the threaded portion of the lead screw. The extension portion 160 can include two leg portions 162 that define a U-shaped aperture or slot 164 therebetween. The release knob 168 can include a slidable member 170 and a user-engageable portion 172, the slidable member 170 being disposed between the leg portions 162 and the user-engageable portion 172 extending radially outwardly from the slidable member 170. The proximal end portion 108 of the release member 106 can be fixedly secured to the slidable member 170, for example, by a suitable adhesive, such that axial movement of the slidable member 170 in the distal and proximal directions causes corresponding movement of the release member.

[0102] The release knob 168 can be configured to be movable with the lead screw 144 and also independently movable from the lead screw 144. As described above, axial movement of the lead screw 144 causes corresponding movement of the positioning member 76. Thus, when the release knob 168 is retained relative to the extension portion 160 of the lead screw 144, axial movement of the lead screw 144 moves the release knob 168 and the release member 106 with the positioning member 76, for example, during placement and inflation of the prosthetic valve. When the release knob 168 is not retained relative to the extension portion 160 of the lead screw 144, the release knob 168 can be translated axially relative to the extension portion, thereby effecting axial movement of the release member 106 relative to the positioning member 76, actuating the clamping mechanism 98 of the locking unit 94, and releasing the positioning member 76 from the frame 22 of the prosthetic valve.

[0103] Various mechanisms can be used to selectively and releasably hold the release knob 168 axially with respect to the extension portion 160 of the lead screw 144. For example, a movable pin or similar mechanism can be inserted through the slidable member 170 and one or both leg portions 162 of the extension portion 160 to maintain the axial position of the slidable member 170 with respect to the lead screw 144. Removing the pin from the slidable member 170 and / or the leg portion 162 allows axial movement of the release knob 168 with respect to the lead screw.

[0104] In another embodiment, the slidable member 170 can be configured to move between a first position and a second position, in which the slidable member 170 is frictionally engaged by the extension portion 160 in the first position and is no longer frictionally engaged by the extension portion 160 in the second position. In the first position, axial movement of the lead screw 144 causes a corresponding movement of the release knob 168. In the second position, the release knob 168 can be axially moved independently of the lead screw 144 in the distal and proximal directions.

[0105] The actuating member 86 can extend proximally beyond the proximal end portion 108 of the release member 106 and can also extend through an axially extending bore or opening 178 formed in the proximal end portion 180 of the handle 70. The actuating member 86 can be selectively fixed to the handle 70 using a clamping (or retaining) mechanism 182. The retaining mechanism 182 can include a plug member 184, a screw member 186 connected to one end of the plug member 184, and a knob 188 connected to the opposite end of the screw member 186. The plug member 184 can be positioned within a radial bore 190 formed in the proximal end portion 180 of the handle 70. The plug member 184 can include a triangular or trapezoidal lower surface which can be seated in contact with and removed from a correspondingly shaped surface 192 of the radial bore 190. In other implementations, the plug member 184 can have a different shape. The screw member 186 extends through a captured nut 194 and rotation of the knob 188 is configured to move the plug member 184 toward or away from the surface 192 of the radial bore 190.

[0106] When the knob 188 is fully tightened (such as by rotating the knob 188 in a first direction), the lower surface of the plug member 184 can clamp the actuating member 86 against the surface 192, thereby fixing the actuating member 86 against movement relative to the handle 70, the shaft 72, the locking unit 94, and the frame 22 of the artificial valve. When the knob 190 is rotated in the opposite direction, the plug member 184 can move away from the surface 192 and the actuating member 86, allowing the actuating member to move relative to the handle 70, the shaft 72, the locking unit 94, and the frame 22 of the artificial valve.

[0107] Using the delivery device 18, to deliver and implant the prosthetic valve 14 to a desired location within the heart (e.g., the native aortic valve), the prosthetic valve 14 is connected to the positioning member 76 using the locking unit 94 and the release member 106, as shown in FIGS. 8 and 9. The release knob 168 is held against the lead screw 144 to prevent relative movement between the positioning member 76 and the release member 106. The prosthetic valve 14 can then be radially compressed or crimped into a compressed state, as shown in FIG. 7. The compressed prosthetic valve 14 can be loaded into the sheath 82 of the shaft 72.

[0108] Conventional techniques and devices can be used to insert and advance the delivery device 18 and the prosthetic valve 14 through the patient's vasculature to the desired implantation site. For example, a prosthetic aortic valve can be delivered in a retrograde approach by advancing the delivery device through the femoral artery and aorta to the native aortic valve. At or adjacent to the implantation site, the prosthetic valve 14 can be deployed from the sheath 82 by rotating the actuator nut 148 in a direction that moves the lead screw 144 distally relative to the handle 70. This moves the positioning member 76 and the release member 106 distally relative to the shaft 72. The positioning member 76 pushes the prosthetic valve 14 distally relative to the shaft 72. The actuator nut 148 can be rotated until the prosthetic valve is deployed from the distal end of the sheath 82. In some implementations, the inherent elasticity of the frame 22 can be used to at least partially expand the prosthetic valve when it is advanced from the sheath 82.

[0109] When the artificial valve 14 is deployed from the sheath 82, the retention mechanism 182 can be in a released position, allowing the actuating member 86 to move distally with the artificial valve. Thus, the actuating member 86 does not apply any expansion force to the artificial valve because it is deployed from the sheath. To apply an expansion force to the artificial valve, the retention mechanism 182 is tightened to hold the actuating member 86 against the handle 70. Continued rotation of the actuator nut 148 causes a distally-directed force to be continuously applied onto the proximal end of the frame 22 against the positioning member, while the actuating member 86 (which is now restrained by the retention mechanism 182) becomes taut and applies a proximally-directed force onto the distal end of the frame 22. Application of these forces shortens the frame 22 axially and expands it radially.

[0110] In some embodiments, when the artificial valve is advanced from the sheath 82, the actuating member is of sufficient length and contains sufficient slack such that the retention mechanism 182 can be maintained in a locked or engaged position against the actuating member 86 during valve deployment to avoid applying any expansion force to the artificial valve. For example, the length of the actuating member 86 can be selected to avoid applying any expansion force to the artificial valve when the artificial valve is advanced from the sheath 82, and after the artificial valve is fully deployed from the sheath, the actuating member 86 becomes taut and begins applying an expansion force to the frame against the expansion force of the positioning member 76 to expand the artificial valve.

[0111] If repositioning of the prosthetic valve or complete withdrawal of the prosthetic valve from the body portion is required, the user can rotate the actuator nut 148 in the opposite direction, which retracts the prosthetic valve into the sheath 82 by the positioning member 76. The action of the distal end portion 110 of the positioning member 76 being retracted into the sheath 82 radially compresses the prosthetic valve. If desired or required, the prosthetic valve can be partially compressed without being retracted into the sheath and then repositioned and reinflated by rotating the actuator nut 148. In some cases, the prosthetic valve can be fully retracted into the sheath 82 for repositioning or for complete withdrawal of the prosthetic valve from the body portion.

[0112] Once the prosthetic valve is inflated and positioned at the desired location, the release member 106 can be retracted from the locking unit 94. This can be achieved by releasing the release knob 168 from the lead screw 144 and retracting the release knob 168 proximally (which retracts the release member 106 relative to the locking unit 94). If the distal end of the release member 106 is proximal to the jaw 102 of the clamping mechanism 98, the jaw can engage the actuating member 86 and keep the prosthetic valve in the inflated state. Further retraction of the release member 106 beyond the tab 122 of the locking unit 94 enables the positioning member 76 to be released from the locking unit. Retraction of the positioning member 76 by rotation of the actuator nut 148 or by retracting the handle 70 pulls the distal end portion 110 of the positioning member freely from the locking unit 94. As discussed above, the proximal portion of the actuating member 86 of the clamping mechanism 98 can be cut and removed from the body portion. Thereafter, the delivery device can be withdrawn from the body portion.

[0113] The frame design discussed above in connection with FIGS. 2 and 4 includes a set of inner struts and a set of outer struts, the outer struts being pivotally connected to the inner struts by rivets or equivalent fasteners (e.g., inner and outer struts 204a, 204b of FIG. 4, respectively). This may require some additional small parts, from 10 to 50, that are fixed to the frame by welding or plastic deformation. For example, individual rivets can be less than 1 millimeter in length (e.g., 0.8 mm) and also less than 1 millimeter in diameter (e.g., 0.8 mm). As can be appreciated, the assembly process for assembling the frame can be time-consuming and can add significant cost to the manufacturing process. And these additional elements can likewise increase the overall crimp profile of the frame.

[0114] Additionally, the outer struts are typically slightly longer than the inner struts, taking into account the fact that the outer struts are positioned radially outward of the inner struts and have a larger radius of curvature than the inner struts. So, due to the different lengths of the inner and outer struts, complete pivotal movement between the inner and outer struts can be inhibited if the frame shortens in the case of radial expansion. To accommodate the different lengths of the inner and outer struts and allow for complete movement of the struts, apertures (e.g., aperture 208) at the joints of the inner and outer struts that receive rivets or other connectors can be slightly elongated and / or enlarged, but this can present issues regarding manufacturing and reliability. Additionally, such a design can introduce additional loads, such as torsional and bending moments acting on the hinge between the struts.

[0115] As shown in FIG. 13, a frame 300 for an artificial heart valve according to another embodiment includes a first set of struts and a second set of struts. The first set of struts includes a plurality of first struts 310 (shown in the figure as extending from the lower left to the upper right). The second set of struts includes a plurality of second struts 320 (shown in the figure as extending from the upper left to the lower right), and the plurality of second struts 320 are intertwined with the first struts 310 such that each strut passes over and under the struts of the other set. In this embodiment, there are no "inner struts" and "outer struts", rather, there are two sets of intertwined struts, so both sets of struts can be of the same length. Then, in some embodiments, the same basic parts can be used for all the struts. In other words, all the struts can have the same size and shape. In some other embodiments, structurally similar struts having only manufacturing differences in and around the areas of potential junctions with other struts can be used.

[0116] Also, in embodiments where the first struts 310 and the second struts 320 are of the same length, the frame can reduce or eliminate any "mismatch" when shortening (i.e., all struts can be shortened by the same amount and it is possible to allow complete movement of the struts during radial expansion) without the need to expand or elongate the apertures 340 at the strut junctions.

[0117] In some embodiments, frame 300 can include separate fasteners (e.g., fastener 40) that extend through respective apertures 340 at strut junctions 315, 325. Advantageously, weaving struts 310 and 320 can reduce the number of hinge connections at junctions 315, 325 between the struts. For example, in some embodiments, the frame can include fasteners (e.g., fastener 40) only at junction 325 that defines the apex at the inflow and outflow ends of the frame. Junction 315, which is axially positioned between junctions 325 at the inflow and outflow ends of the frame, can be free of any fasteners that interconnect a pair of overlapping struts. Instead, due to the weaving of the struts and the inherent elasticity of the struts, the struts can be installed in a tensioned state, thereby urging the first and second struts together at each junction. The tension applied to the struts at junction 315 can be sufficient to hold the strut assembly together, along with the mechanical connection at junction 325.

[0118] In an alternative embodiment, the frame 300 includes fasteners at selected joints 315 and can reinforce the connection between the struts 310, 320 according to the overall size and shape of the frame. For example, in one implementation, the frame 300 can include fasteners only at the joint 315 in the middle of the frame (i.e., the joint 315 that intersects the plane that bisects the frame midway between the inlet end and the outlet end of the frame). For purposes of illustration, each strut 310, 320 is shown as having an aperture at each joint 325 by overlapping struts. However, in the embodiments described above where there are no fasteners at the selected joint 315, the struts 310, 320 need not be formed with any apertures 340 at the selected joint. As can be appreciated, reducing the number of fasteners required to assemble the frame can significantly reduce the manufacturing cost.

[0119] In other embodiments, rather than using separately formed fasteners (e.g., rivets) that are typically manually inserted into the apertures at each joint to form hinges, the frame 300 can have integral fasteners at the strut joints 315, as shown in the embodiments in FIGS. 14A - 18 and further discussed herein.

[0120] FIGS. 14A and 14B illustrate a frame 400 of one embodiment for an artificial heart valve, the frame having integral fasteners for forming hinges between overlapping struts. In this embodiment, the frame 400 includes a first set of struts 410 that are intertwined with a second set of struts 420. For example, the first strut 410a of the first set of struts 410 can be intertwined with at least the second strut 420a, the third strut 420b, and the fourth strut 420c of the second set of struts 420.

[0121] Each first strut 410 can include a plurality of integral protrusions or projections 414 spaced from one another along the length of the strut. Each second strut 420 can include a plurality of openings or apertures 430 spaced from one another along the length of the strut, and each aperture is configured to receive a respective protrusion 414, forming a hinge between two overlapping first and second struts. As shown, the protrusions 414 extend alternately from one protrusion to the next, from one side of the strut 410 and from the other side of the strut, enabling each protrusion 414 to extend into a corresponding aperture 430 of the overlapping strut 420 within the fabric.

[0122] As used herein, the terms "integral" or "integrally formed" or "unitary structure" represent a structure of a component that does not include any seams between different parts of the component. Further, the terms "integral" or "integrally formed" or "unitary structure" represent a structure that does not include any welding, fasteners, adhesives, or other means for fixing pieces of separately formed materials to one another. Thus, the integral protrusions 414 (or other features of the strut) are formed directly on the strut rather than being formed separately and then attached to the strut.

[0123] As shown in FIG. 14B, the first strut 410 can be elastically deformed since it weaves through successive second struts 420a, 420b, 420c. Due to the elasticity of the struts, the struts are installed in a tensioned state, urging the first strut to contact the respective second strut at each joint (illustrated by force lines 432), which helps keep the respective protrusions 414 within the apertures 430. In some embodiments, the struts can initially be straight and then elastically bent when they are woven together. In other embodiments, the first and / or second struts can be pre-formed with curves or bent at the location of the joints (such as by thermally curing a shape memory material) to facilitate the assembly of the frame. The struts can be formed from, for example, a superelastic material (nitinol) or a non-superelastic material (e.g., stainless steel or cobalt-chromium alloy), but in certain embodiments, a superelastic material is desirable to maximize the elastic retention force 432 at the joints of the struts.

[0124] In the illustrated embodiment, the struts 410, 420 of the frame 400 are arranged in a basic or plain weave pattern where each first strut 410 extends over and then under each successive second strut 420. In alternative embodiments, the struts 410, 420 can be arranged in various other weave patterns. The placement of the protrusions 414 can be modified from the configuration shown in FIG. 14B and can correspond to the location of the joints formed by a particular weave pattern of the struts.

[0125] Struts 410, 420 can be manufactured using any of a variety of suitable techniques as previously described herein. In some embodiments, the struts can be laser cut from a tube, for example, or can be laser cut or punched from a flat sheet of metal. Optionally, the struts can experience an additional rolling process to shape them into their final shape prior to assembly. In some embodiments, the struts can be formed with a plurality of spaced-apart tab portions that are plastically bent or heat cured to form a plurality of protrusions.

[0126] Figures 15A and 15B illustrate alternative embodiments of a pair of first and second struts 500 and 550, respectively, which can be used to form a frame from a plurality of first struts 500 and a plurality of second struts 550. In certain embodiments, each strut 500, 550 is formed (e.g., laser cut) from a flat sheet of material (e.g., a flat sheet of metal) and can form a strut having a radius of curvature that defines a curved outer surface of the frame when assembled together with other similar struts to form the frame.

[0127] Figures 15A and 15B show the struts as viewed from the axial ends of the frame. Thus, strut 500 has an inner surface 502 facing radially inward and a surface 504 facing radially outward, where inner surface 502 forms part of the inner surface of the frame and surface 504 facing radially outward forms part of the outer surface of the frame. Strut 500 has a radial thickness T1 defined between surfaces 502, 504. Also, strut 500 has longitudinally extending axially facing side surfaces 506, 508 (see also FIG. 16A), and side surfaces 506, 508 define a width W1 equal to the thickness of the sheet of material from which the strut is formed.

[0128] Similarly, strut 550 has an inner surface 552 facing radially inward and a surface 554 facing radially outward. The inner surface 552 forms part of the inner surface of the frame, and the surface 554 forms part of the outer surface of the frame. Strut 550 has a radial thickness T2 defined between surfaces 552, 554. Further, strut 550 has side surfaces 556, 558 (see also FIG. 16A) facing in the axial direction extending longitudinally, and the side surfaces 556, 558 define a width W2 equal to the thickness of the sheet of material from which the strut is formed, as best shown in the side view of FIG. 15C.

[0129] Struts 500, 550 can be formed with integral features that mate with corresponding features of the overlapping struts and form a hinge at the junction of the two struts. In particular, strut 500 can be formed with integral protrusions 510 at opposite ends of the strut, and can also be formed with integral protrusions 520 spaced apart along the length of the strut between the end protrusions 510. Strut 550 can be formed with a plurality of apertures 560 spaced apart along the length of the strut at locations corresponding to the locations of protrusions 510, 520, as best shown in FIGS. 15B and 15C. Each of the protrusions 510, 520 can be received into a corresponding aperture 560 of the overlapping strut and can form a hinge at the junction of the two struts 500, 550. As shown in FIG. 15A, the protrusions 510, 520 extend alternately along the inner surface 502 and the outer surface 504 in the illustrated embodiment. Thus, some of the protrusions extend radially inward from surfaces 502, 504, and some of the protrusions extend radially outward from surfaces 502, 504. In this way, each first strut 500 can be interwoven with a plurality of second struts 550, similar to struts 310, 320 of FIG. 13.

[0130] Struts 500, 550 having integral features for forming a hinge interconnecting two struts can be formed using any of a variety of suitable techniques including, without limitation, laser cutting, stamping, machining, electrolytic etching, electroforming, or three-dimensional printing. For example, the integral protrusions 510, 520 can be formed directly on the strut 500 by forming the entire shape shown in FIG. 15A from a single piece of material.

[0131] Each protrusion 510 at the opposite end of the strut 500 forms the apex of the frame when inserted into the corresponding aperture 560 of the strut 550. Further, as shown in FIG. 15A, the protrusion 510 can be configured to form a snap-fit connection or engagement with the corresponding aperture 560. For example, in the illustrated embodiment, each protrusion 510 includes a split protrusion having a first portion 512a and a second portion 512b separated by a gap. Each of the first and second portions 512a, 512b can have a relatively narrow base 514 on the inner surface 502 and can have a tapered relatively wider end portion 516 spaced from the inner surface 502. The gap allows the first and second portions 512a, 512b to be displaced toward each other when the relatively wider end portion 516 is inserted through the aperture 560. When the end portion 516 is allowed to pass completely through the aperture 560, the first and second portions 512a, 512b can return, under their own elasticity, to their non-deflected state (shown in FIG. 15A), and the relatively wider end portion 516 serves to prevent the protrusion 510 from exiting or separating from the aperture.

[0132] The protrusion 520 does not necessarily need to be fastened or retained inside the corresponding aperture 560 by a snap fit connection or other fastener. In certain embodiments, the connection between two struts at the apex of the frame, along with the intervening struts as described above, can be sufficient to hold the protrusion 520 within the corresponding aperture 560 when the frame is assembled.

[0133] In certain embodiments, the frame can be assembled by a plurality of struts 500, 550 without using any other components (such as separate rivets and / or washers) to form a hinge connection at the junction of the two struts 500, 550. As can be appreciated, the assembly process is much less time-consuming and also less costly than a frame that requires separate components to form the hinge connection.

[0134] In an alternative embodiment, all of the protrusions 510, 520 can be formed on a single side (side 502 or side 504) of the strut 500, in which case the struts 500, 550 are not interwoven with each other. In yet other embodiments, the protrusions can be staggered at intervals other than a single interval and adapted to correspond to different "weaving" patterns for the struts 500, 550. For example, a single strut 500 can extend under two adjacent struts 550 and then extend over the next two adjacent struts 550.

[0135] FIG. 16A is a side view of a joint formed between a first strut 500 and a second strut 550 according to one embodiment. As shown, the first strut 500 passes under the second strut 550 at the point of engagement or joint between the struts. At this joint, the protrusion 520 of the first strut 500 extends into the aperture hole 560 in the second strut 550, providing a hinged connection such that when the frame assembled from the plurality of struts 500, 550 expands or contracts radially, the struts can rotate around the hinged connection.

[0136] FIG. 16B is a cross-sectional view taken along line 16B-16B of FIG. 16A. At other joints along the first strut 500 where the first strut 500 interacts with other second struts 550, the first strut can instead pass over the next second strut, with the protrusion 520 facing radially inwards towards the second strut 550 and extending into the corresponding aperture 560 of that second strut. Additionally, in the case where each of the struts is connected to another strut at the apex of the frame, it is possible that neither the protrusion 520 nor the aperture 560 formed in the strut is present at a particular joint between the first strut 500 and the second strut 550.

[0137] In the embodiments of FIGS. 16A and 16B, the protrusion 520 has a square cross-sectional profile in a plane perpendicular to the pivot axis 522 of the protrusion. In other embodiments, the protrusion can have other cross-sectional shapes such as circular, triangular, etc.

[0138] FIG. 17 shows another embodiment of a hinged connection 700 formed by a first strut 710 and a second strut 720. The first strut 710 has a protrusion 712 that can be formed by flow drilling. Similar to the embodiment shown in FIG. 15B, the second strut 720 can include an aperture 722 cut or drilled therein, and the protrusion 712 can seat within the aperture 722 such that the two struts are pivotally engaged and can pivot relative to each other about a pivot axis 714. In another embodiment, rather than drilling the aperture 722 completely through the second strut 720, the second strut can instead include a non-through hole or recess formed by stamping, etching, or other means, etc., and the protrusion 712 can extend therein and provide a pivotal engagement between the struts.

[0139] FIGS. 18A-18C show another embodiment of a hinge connection 800 between two struts 810, 850 formed by integral features on the struts. In this embodiment, the first strut 810 can include an enlarged node 812 at the location of each joint between the two struts. The node 812 is wider than the remainder of the strut and can be circular in shape as shown, although in other embodiments other shapes can also be used.

[0140] The first strut 810 includes a surface 814 facing radially outward, a surface 816 facing radially inward, and two longitudinally extending surfaces 818 facing axially. Two stopper tabs 820 are formed on either side of the node 812 and extend radially inwardly towards the second strut 850. One stopper tab 820 extends radially inwardly from one surface 818, and the other stopper tab 820 extends radially inwardly from the other surface 818. Also, the first strut 810 can have a notch 822 formed in the surface 818 adjacent to the stopper tab 820.

[0141] The second strut 850 is similarly formed with enlarged nodes 852 at the location of each joint. The second strut 850 includes a surface 854 facing radially outward, a surface 856 facing radially inward, and two longitudinally extending surfaces 858 facing axially. Two stopper tabs 860 are formed on either side of the node 852 and extend radially outwardly towards the first strut 810. One stopper tab 860 extends radially outwardly from one surface 858, and the other stopper tab 860 extends radially outwardly from the other surface 858. Also, the second strut 850 can have a notch 862 formed in the surface 858 adjacent to the stopper tab 860.

[0142] As shown in FIGS. 18A and 18B, struts 810, 850 are disposed opposite to each other, with node 812 of the first strut overlapping node 852 of the second strut to form hinge 800. Stopper tab 820 of the first strut 810 extends radially inwardly along the opposite side portion of node 852 of the second strut 850, while stopper tab 860 of the second strut 850 extends radially outwardly along the opposite side portion of node 812 of the first strut 810. When struts 810, 850 are pivoted relative to each other about pivot axis 870, stopper tab 820 of the first strut can engage the opposing side portion 858 of the second strut, while stopper tab 860 of the second strut can engage the opposing side portion 818 of the first strut. Thus, stopper tabs 820, 860 limit the rotational movement of the struts relative to each other. Accordingly, the frame formed by the plurality of struts 810, 850 can have a maximum expansion diameter and a minimum compression diameter determined by the range of strut movement allowed by the stoppers, and can help avoid over-expansion and / or over-compression beyond desired limit values.

[0143] Furthermore, the engagement of stopper tab 820 against the outer side surface of node 852, and the engagement of stopper tab 860 against the outer side surface of node 812 can resist at least axial separation of the struts. In some embodiments, struts 810, 850 are woven together as shown in FIG. 13, placing the struts in tension opposite to each other and being able to resist radial separation of the struts. When the struts are woven together, a pair of stopper tabs 820 spaced along the length of the strut can extend alternately from surface 814 and from surface 816. Similarly, a pair of stopper tabs 860 spaced along the length of the strut can extend alternately from surface 854 and from surface 856.

[0144] Figures 19A - 19C illustrate a strut connector 900 (also referred to as a "rivet chain" in some embodiments) that can be used to interconnect the struts of a frame of an artificial heart valve according to another embodiment. In the illustrated embodiment, the strut connector 900 includes a plurality of rivets or protrusions 910 connected by a support member 912, and the support member 912 is preferably formed as a unitary part together with the protrusions 910 integrally formed on the support member 912. In one embodiment, the strut connector 900 can be manufactured using electrochemical machining (ECM), although it can be fabricated using a plurality of other suitable different techniques such as electrical discharge machining (EDM), laser machining, or computer numerical control (CNC) machining, or molding. Also, other suitable processes can be used.

[0145] The strut connector 900 need not be made of the same material as the frame to which it is attached. This is because it is a separate part from the frame struts. The strut connector 900, including the protrusions 910 and the support member 912, can be formed from either various biocompatible metals (e.g., stainless steel, nitinol) or polymers (e.g., polyurethane). The strut connector 900 preferably has sufficient flexibility to conform to the curvature of the outer or inner surface of the strut against which it is placed, as further described below.

[0146] FIG. 20 is a perspective view of a frame 1000 according to one embodiment that can be assembled using strut connectors 900. In the illustrated embodiment, the frame 1000 includes a plurality of first outer struts 1002 connected to a plurality of second inner struts 1004. The frame 1000 can have a construction similar to that of the frame 200 of FIG. 4, except for the hinge-type connections between the struts. Each strut 1002, 1004 can be formed with a plurality of apertures where the struts overlap each other, as previously described in connection with the frame 200. The strut connectors 900 can be installed along the outer surface of each outer strut 1002, and each protrusion 910 extends through an aperture in the outer strut 1002 and into a corresponding aperture in the inner strut 1004. The hinge-type connection is thereby formed at the junction of each of the first strut 1002 and the second strut 1004.

[0147] In an alternative embodiment, the strut connectors 900 can be installed against the inner surface of each inner strut 1004, and each protrusion 910 extends through an aperture in the inner strut 1004 and into a corresponding aperture in the outer strut 1002. In yet another alternative embodiment, the strut connectors 900 need not be formed with protrusions at all the junctions between the struts 1002, 1004. For example, in one particular implementation, the strut connector 900 can be formed with a protrusion 910 at its opposite ends and be configured to form hinge-type connections at the apexes along the inlet and outlet ends of the frame, and optionally, include a protrusion 910 at one or more selected locations along the length of the strut connector and be capable of forming hinge-type connections between the inlet and outlet ends of the frame.

[0148] Furthermore, the illustrated frame 1000 includes a single strut connector 900 aligned along each strut 1002, although in other embodiments, multiple strut connectors 900 may be installed connecting end-to-end along the length of each strut 1002 (or, if installed inside the frame, each strut 1004). Moreover, the strut connector 900 can be implemented in other frame designs. For example, in one implementation, the frame can be formed from a plurality of interwoven first and second struts, similar to FIG. 13.

[0149] As can be appreciated, the use of strut connectors 900 for assembling the frame can greatly facilitate the manufacturing process by eliminating the step of manually installing individual rivets at each joint between the struts.

[0150] FIGS. 21 - 28 illustrate another embodiment of a frame 1100 for an artificial heart valve. As shown in FIG. 21, in the illustrated embodiment, the frame 1100 is formed from a plurality of inner struts 1110 and a plurality of outer struts 1120 connected by hinges 1115 at joints 1105. In an alternative embodiment (not shown), the struts can be interwoven, similar to the embodiment of FIG. 13.

[0151] Frame 1100 can include a plurality of actuators 1130, the plurality of actuators 1130 being configured to radially expand and contract the frame and to maintain an expanded shape when placed inside a patient's body. Each actuator 1130 can include an inner member or piston 1132 that extends through an outer member or cylinder 1134. The inner member 1132 can be connected at one of its ends to a junction 1105 at one end of the frame, while the outer member 1134 can be connected to another junction 1105 of the frame. Longitudinal movement of the inner member 1132 relative to the outer member 1134 is effective to radially expand and contract the frame 1100 as previously described in connection with the embodiments of FIGS. 1 and 8-12. The inner member 1132 can be releasably connected to a corresponding actuator of the delivery device. Further details of the actuator 1130 are disclosed in co-pending application Ser. No. 15 / 831,197, filed Dec. 4, 2017.

[0152] The components forming the hinge 1115 can be integrated into the strut structure. As best shown in FIGS. 22-26, for example, each strut 1110 includes a plurality of integral protrusions 1112 spaced along the length of the strut at the location of the junction 1105. Each protrusion 1112 can include a cylindrical base 1114 and a locking member in the form of a plurality of ears 1118 that extend laterally from an end of the base 1114. In the illustrated embodiment, each protrusion includes two ears 1118 that extend in opposite directions from an end of the base 1114, although in alternative embodiments, three or more ears 1118 can be used.

[0153] Each strut 1120 can be formed with a plurality of openings or apertures 1122 spaced along the length of the strut at the location of the joint 1105. Each opening 1122 can include two oval side portions 1124 corresponding to the shape of the ear 1118. Each opening 1122 can be formed in a recessed portion 1126 formed on the outer surface of the strut 1120.

[0154] In the assembled state of the frame 1100, the base 1114 of each protrusion 1112 extends through the corresponding opening 1122, and the ear 1118 is in a state of being present in the recessed portion 1126 surrounding the opening. The depth of the recessed portion 1126 is desirably equal to or greater than the height of the ear 1118 so that the protrusion does not extend radially beyond the outer surface of the outer strut 1120. The ear 1118 and the correspondingly shaped oval side portion 1124 allow the ear of the protrusion 1112 to be inserted through the side portion 1124 when the ear 1118 and the oval side portion 1124 are rotated and aligned with each other, and then prevent the separation of the two struts 1110, 1120 when the ear 1118 and the side portion 1124 are rotated and offset from each other or in a non-aligned state.

[0155] During assembly, the ear 1118 of the strut 1110 aligns with the oval side portion 1124 of the opening 1122 of the strut 1120 and corresponds to a predetermined angle between the struts 1110, 1120, which is greater than the maximum angle between the struts 1110, 1120 allowed by the actuator 1130 during the radial expansion of the frame 1100. Thus, to form the frame, when the protrusion 1112 of the strut 1110 is inserted through the corresponding opening 1122 of the strut 1120, the struts are then rotated relative to each other, whereby the ear 1118 is offset from the oval side portion 1124. The actuator 1130 can then be mounted on the frame. The actuator 1130 is configured to radially expand and contract the frame as described above, but desirably limits the radial expansion and contraction of the frame within a range of a predetermined diameter and within a range of a predetermined angle between the struts 1110, 1120 where the ear 1118 remains offset in the rotational direction from the oval side portion 1124. In this way, the actuator 1130 can prevent the frame from radially expanding until the diameter at which the ear 1118 is rotationally aligned with the oval side portion 1124, thereby preventing separation of the struts 1110, 1120 at any of the joints 1105. Similarly, the actuator 1130 can prevent the frame from radially contracting until the diameter at which the ear 1118 is rotationally aligned with the oval side portion 1124, thereby preventing separation of the struts 1110, 1120 at any of the joints 1105 when the frame is compressed in the delivery configuration.

[0156] In this way, the hinge 1115 formed by the protrusion 1112 and the corresponding opening 1122 can be referred to as a "self-locking" hinge in that the mechanical engagement between the ear 1118 and the adjacent surface of the recessed portion 1126 does not need to rely on placing the struts in a tensioned state relative to each other in order to lock the struts together at the joint 1105 and maintain the connection between the struts. As a result, the struts do not need to be formed from a superelastic material (e.g., nitinol) in order to maximize the tension on the struts. The struts can be formed from a superelastic material or a non-superelastic material (e.g., stainless steel or cobalt-chromium alloy), although in some embodiments, a non-superelastic material is desirable because they can provide greater crush resistance and are typically less expensive than superelastic materials.

[0157] The self-locking hinge 1115 can be formed from protrusions 1112 and openings 1122 having any of a variety of shapes in addition to those shown in the illustrated embodiment. Generally, the protrusion 1112 can be formed with a locking member having a non-circular shape (in a plane perpendicular to the central axis of the protrusion), and the opening 1122 can be aligned in the rotational direction with the locking member to allow assembly of the struts, and then can have any non-circular shape that is offset in the rotational direction from the locking member and can prevent separation of the struts at the hinge.

[0158] In certain embodiments, frame 1100 can be assembled as follows. Referring to FIG. 27, inner strut 1110 can be mounted on mandrel 1150, and then outer strut 1120 can be placed on inner strut 1110. The inner and outer struts are installed at a predetermined angle relative to each other, aligning ear 1118 of inner strut 1110 with oval opening 1124 of outer strut 1120 in the rotational direction, which allows the protrusion to be inserted through the opening and enables ear 1118 to be present within recessed portion 1126. Thereafter, the frame can be slightly crimped to offset ear 1118 rotationally from oval opening 1124, thus locking the struts in place at each joint 1105 as shown in FIG. 27. Then, actuator 1130 can be mounted on frame 1100. As described above, actuator 1130 preferably limits the radial expansion of the frame such that the struts do not reach the angle at which they are assembled. For example, actuator 1130 can be configured to limit the radial expansion of the frame to the expansion configuration shown in FIG. 27. FIG. 28 shows the frame 1110 in a radially compressed state, which can be the minimum diameter of the frame allowed by actuator 1130. As shown, in the minimum compressed state allowed by the actuator, ear 1118 is still rotationally offset from oval opening 1124, preventing separation of the struts in the compressed state.

[0159] Figures 29-33 illustrate another embodiment of a hinge assembly 1200 for an artificial heart valve. As shown in Figure 29, in the illustrated embodiment, the hinge assembly 1200 is formed from an inner strut 1220 and an outer strut 1230, and the inner strut 1220 and the outer strut 1230 are connected by a separate hinge member 1202 at a junction 1205. The hinge assembly 1200 is similar to the hinge shown in Figure 22, except that in Figure 22, the connector between the two struts is formed from an integral projection from one of the struts that fits into an opening in the corresponding strut. In the embodiment shown in Figure 29, the hinge assembly 1200 is formed using a separate hinge member 1202 that is not integral with either the inner strut 1220 or the outer strut 1230, as best shown in Figures 30-32B. It is understood that a plurality of such hinge assemblies can be used to form a frame and that in an alternative embodiment (not shown), rather than providing inner and outer struts, the struts can be woven together as in the embodiment of Figure 13. Although described as being inserted first through the inner strut 1220, it is further understood that the hinge member 1202 can be inserted first through the outer strut 1230.

[0160] As best shown in FIGS. 30A - 30C, the hinge member 1202 can include a disk - shaped base 1212, and a cylindrical protrusion 1214 extends from the base 1212. One or more retaining members in the form of one or more ears 1216 of a first set that extend laterally from the cylindrical protrusion 1214 are at a first end of the cylindrical protrusion adjacent to the base 1212. The second end of the cylindrical protrusion (opposite the base 1212) is one or more locking members in the form of one or more ears 1218 of a second set. In the illustrated embodiment, each set of ears 1216 and 1218 includes two ears that extend in opposite lateral directions from the cylindrical protrusion 1214, although in alternative embodiments, three or more ears may be used.

[0161] Similar to the embodiment of the frame 1100, the inner strut 1220 can be formed with a plurality of inner openings or apertures 1222 spaced along the length of the strut at the location of the joint 1205 with the outer strut 1230. As best shown in FIG. 31A, each inner opening 1222 can include two inner oval side portions 1224 corresponding to the shape of the two sets of ears 1216 and 1218. Each inner opening 1222 can be formed in an inner circular recessed portion 1226 formed on the inner surface of the inner strut 1220, and the disk-shaped base 1212 of the hinge member 1202 can be seated in the inner circular recessed portion 1226 as best shown in FIG. 32A. The depth of the inner circular recessed portion 1226 is desirably equal to or greater than the height of the disk-shaped base 1212 so that when the hinge frame assembly 1200 is assembled, the hinge member 1202 does not extend radially beyond the inner surface of the inner strut 1220. As best shown in FIG. 32B, when the cylindrical protrusion 1214 of the hinge member 1202 and the second set of ears 1218 are inserted through the inner opening 1222 of the inner strut 1220, the first set of ears 1216 is retained in the oval side portion 1224 of the inner opening 1222 to prevent axial and rotational movement of the hinge member 1202 relative to the inner strut 1220.

[0162] Similar to the embodiment of the frame 1100, the outer strut 1230 can also be formed with a plurality of outer openings or apertures 1232 spaced along the length of the strut at the location of the joint 1205 with the inner strut 1220. As best shown in FIG. 31B, each outer opening 1232 can include two outer oval side portions 1234 corresponding to the shape of the second set of ears 1218. Each outer opening 1232 can be formed in an outer circular recessed portion 1236 formed on the outer surface of the outer strut 1230, and the second end of the cylindrical protrusion 1214 and the second set of ears 1218 can be held in the outer circular recessed portion 1236, as best shown in FIG. 33, which shows the assembly configuration of the hinge frame assembly 1200. The depth of the outer circular recessed portion 1236 is desirably equal to or greater than the height of the second set of ears 1218 so that when the hinge frame assembly 1200 is assembled, the hinge member 1202 does not extend radially beyond the outer surface of the outer strut 1230.

[0163] When assembled over the frame, the cylindrical projections 1214 extend through corresponding openings 1232 in the outer strut 1230, with the second set of ears 1218 being in a position within the outer recessed portion 1226 surrounding the opening. The portion of the outer strut 1230 surrounding the opening 1232 in the recessed portion 1236 is within the gap 1240 (FIG. 30C) between the first set of ears 1216 and the second set of ears 1218, allowing the outer strut 1230 to pivot or rotate relative to the inner strut 1220 and the hinge member 1202. The second set of ears 1218 and the correspondingly shaped outer oval side portion 1234 are such that during assembly, when the second set of ears 1218 and the outer oval side portion 1234 are rotationally aligned with each other, the second set of ears 1218 can be inserted through the outer oval side portion 1234, and then, when the second set of ears 1218 and the outer oval side portion 1234 are rotated and offset from each other or in a non-aligned state, prevent separation of the two struts 1220, 1230.

[0164] During assembly, in a manner similar to that described above with respect to the embodiment of the frame 1100, after the second set of ears 1218 of the hinge member 1202 are first inserted through the inner strut 1220, they are aligned with the outer oval side portion 1234 of the opening 1232 in the outer strut 1230, corresponding to a predetermined angle between the struts 1220, 1230, which predetermined angle is greater than, for example, the maximum angle between the struts 1220, 1230 allowed by the actuator 1130 during radial expansion of the frame. Thus, when the second set of ears 1218 of the hinge member 1202 are inserted through the corresponding openings 1224 and 1234 of both sets of struts to form the hinge of the frame, the struts are then rotated relative to each other, whereby, as best shown in FIG. 29, the second set of ears 1218 will be offset from the outer oval side portion 1234.

[0165] Similar to the frame 1100, after all the hinges are assembled, the actuator 1130 can then be mounted on the frame. The actuator 1130 is configured to expand and contract the frame radially as described above, but desirably within a range of a predetermined diameter and within a range of a predetermined angle between the struts 1220, 1230 where the second set of ears 1218 remains rotationally offset from the outer oval side portion 1234, which limits the radial expansion and contraction of the frame.

[0166] For example, the frame diameter in the assembly configuration of FIG. 33 can be 29 mm, while the range of the frame diameter between the minimum (crimped) diameter of the frame and the maximum allowable operating diameter of the frame can be between 8 mm and 28 mm, respectively. Thus, the actuator 1130 can prevent the frame from expanding radially until the second set of ears 1218 is rotationally aligned with the outer oval side portion 1234, thereby preventing separation of the struts 1210, 1230 at any of the joints 1205. Similarly, the actuator 1130 can prevent the frame from contracting radially until the ears 1218 are rotationally aligned with the oval side portion 1234, thereby preventing separation of the struts 1210, 1230 at any of the joints 1205 when the frame is compressed in the delivery configuration. Additionally, when rotationally offset from the outer oval side portion 1234, the second set of ears 1218 can interact with the outer surface of the outer strut 1230 and prevent radial movement of the hinge member 1202 with respect to the struts 1220, 1230.

[0167] In this way, the hinge assembly can be referred to as "self-locking" in that the mechanical engagement between the ear portion 1218 and the adjacent surface of the outer recessed portion 1236 does not need to rely on placing the struts in tension relative to each other to lock the struts together at the joint 1105 and maintain the connection between the struts. As a result, the struts do not need to be formed from a superelastic material (e.g., nitinol) to maximize the tension on the struts. The struts can be formed from a superelastic material or a non-superelastic material (e.g., stainless steel or cobalt-chromium alloy), but in some embodiments, a non-superelastic material is desirable because they can provide greater crush resistance and are typically less expensive than superelastic materials. Additionally, providing a separate hinge member can simplify the manufacturing process for the struts by eliminating the need to specially manufacture struts with three-dimensional hinge protrusions. This can reduce the overall manufacturing cost.

[0168] The hinge assembly 1200 can include a hinge member 1202 having features corresponding to the openings in the struts, and the features can have any of a variety of shapes in addition to those shown in the illustrated embodiment. Generally, the hinge member can be formed with a locking member (e.g., the ear portion 1218) having a non-circular shape (in a plane perpendicular to the central axis of the hinge member), and the corresponding opening in the outer strut 1230 can be aligned with the locking member in the rotational direction to allow assembly of the struts and then offset from the locking member in the rotational direction and can have any non-circular shape that can prevent separation of the struts at the hinge.

[0169] Similarly, the hinge member can be formed with a retaining member (e.g., ear 1216) having a non-circular shape (in a plane perpendicular to the central axis of the hinge member), and the corresponding openings 1222 in the inner strut 1220 can be aligned with the retaining member in the rotational direction, allowing insertion of the hinge member through the openings 1222 and preventing rotation of the hinge member relative to the inner strut 1220, and can have any non-circular shape. In an alternative embodiment, the hinge member can be formed without features (e.g., ear 1216) that prevent relative rotation between the hinge member and the inner strut 1220.

[0170] In certain embodiments (not shown), a frame using a plurality of hinge assemblies 1200 can be assembled in a manner similar to the frame 1100 shown in FIGS. 27 and 28. In such embodiments, the hinge members 1202 can first be inserted, as shown in FIGS. 31A - 32B, into each of the appropriate openings 1222 in the inner strut 1220 prior to mounting them on the mandrel 1150 as described above. Thereafter, the outer strut 1230 can be mounted over the inner strut 1220, and the assembly can continue in a manner similar to that described with reference to FIGS. 27 and 28. As briefly described above, in other embodiments, the hinge members 1202 can be inserted in the opposite direction through the struts 1220, 1230 such that the base 1212 of each hinge member is adjacent to the outer surface of the outer strut and the ear 1218 is adjacent to the inner surface of the inner strut.

[0171] Figures 34 to 37 illustrate a flanged rivet or connector 1300 that can be used to interconnect the struts of a frame of an artificial heart valve according to another embodiment. Referring to Figure 34, in the illustrated embodiment, the rivet 1300 includes two elongated cylindrical end portions 1302, 1304 separated by a wide central portion or flange 1306. Additionally, an axially extending opening or bore 1308 shaped in a cylindrical form can extend completely through the rivet 1300.

[0172] Figure 35A is a perspective view of a frame 1400 that can be assembled using a flanged rivet 1300 according to one embodiment. In the illustrated embodiment, the frame 1400 includes a plurality of first inner struts 1410, and the plurality of first inner struts 1410 are connected to a plurality of second outer struts 1420. The frame 1400 can have a structure similar to the frame 200 of Figure 4, except for the configuration of the hinge-like connections between the struts. Each strut 1410, 1420 can be formed with a plurality of apertures 1402 where the struts overlap each other, as previously described in relation to the frame 200. Additionally, as shown in more detail in Figure 36, each of the apertures 1402 can include a countersunk hole or enlarged recessed portions 1412, 1422, as previously described in Figure 3B. The countersunk holes or enlarged recessed portions 1412, 1422 are sized to receive one of the two elongated end portions 1302, 1304 in both the initial configuration and the second configuration, and the second configuration follows the deformation of the two elongated end portions 1302, 1304, as will be further described herein.

[0173] As shown in FIGS. 35B and 36, in the initial (undeformed) configuration, the wide flange 1306 of the flanged rivet 1300 is installed at their aperture 1402 between the first inner strut 1410 and the first outer strut 1420. In this initial configuration, the radially innermost terminal end of the end portion 1302 can extend beyond the inner surface of the inner strut 1410. Similarly, the radially outermost end of the end portion 1304 can extend beyond the outer surface of the outer strut 1420.

[0174] As shown in FIG. 37, in the second configuration, the end portions 1302, 1304 are deformed, for example, by plastic deformation, etc., to form end flanges 1312, 1314 at the opposing ends of the rivet. Each end flange has a diameter larger than the diameter of the aperture 1402 in the adjacent struts 1410, 1420. Desirably, at least one of the end flanges is not seated tightly against the adjacent surface of the adjacent strut, allowing at least one of the struts to pivot freely with respect to the rivet and the other strut.

[0175] In a particular embodiment, the end flanges can be fully received within the enlarged recessed portions 1412, 1422 of the adjacent struts 1410, 1420, respectively. For example, the end flange 1312 formed by the end portion 1302 can be coplanar with the inner surface of the inner strut 1410, and the end flange 1314 formed by the end portion 1304 can be coplanar with the outer surface of the outer strut 1420. Thus, the flanged rivet 1300 does not increase or contribute to the overall crimp profile of the prosthetic valve and does not interfere with or unduly stress the valve delivery sheath (e.g., sheath 82 in FIG. 1).

[0176] The end portions 1302, 1304 can be deformed simultaneously or separately. For example, the end portions 1302, 1304 can be deformed by applying a compressive force directed axially to the opposite end of the rivet and / or by applying a force directed radially outward (e.g., using a caulking tool) into the bore 1308, and the end portions 1302, 1304 are deformed into the shape shown in FIG. 37. In one alternative embodiment (not shown), rather than installing the rivet 1300 between the two struts in the initial configuration, the end portion 1302 of the rivet 1300 can be inserted through the aperture 1402 in the first inner strut 1410, and the first end portion 1302 can be deformed to form the end flange 1312 such that the rivet 1300 is effectively held by the first inner strut 1410. Subsequently, the first inner strut 1410 can be connected to the second outer strut 1420 by inserting the second end portion 1304 of the same rivet 1300 through an opening in the outer strut and deforming the second end portion 1304 to form the end flange 1314. In yet another alternative embodiment, the rivet 1300 can be connected to the outer strut 1420 in a similar manner first, before the outer strut is connected to the inner strut 1410.

[0177] Providing a flanged rivet such as those described in the present disclosure can provide benefits in both safety and ease of assembly. Since the rivet is held between the struts, this can reduce the risk of separation of the rivet from the strut. Additionally, in embodiments where the rivet is pre-mounted to the strut, this can simplify assembly by holding the rivet in place while the corresponding strut is attached. Additionally, manufacturing the struts separately from the rivets can potentially minimize the cost of manufacturing the struts by enabling them to be manufactured from flat sheets, while also enabling the optimization of engineering for these separate components (i.e., the rivet and the strut), which may perform different functions and require different mechanical properties.

[0178] Figures 38A, 38B, and 39 show another embodiment of a flanged rivet 1500 formed by drilling or otherwise forming first and second non-through hole portions 1508, 1510 in first and second end portions 1502, 1504 of the rivet. The rivet 1500 can have a wide flange or central portion 1506 intermediate the end portions. The rivet 1500 can be assembled onto two struts 1410, 1420 by the deformed end portions 1502, 1504, as previously described.

[0179] Figures 40A - 40C show another embodiment of a rivet 1600 with a flange, which is formed by deforming a simple tube or cylindrical member 1602 (Figure 40A). The simple tube or cylindrical member 1602 has first and second end portions 1604, 1606 respectively, and also has a longitudinal opening or bore 1608 extending therethrough. A compressive force can be applied to the opposing ends of the tube 1602 (shown by arrow 1612), plastically deforming the tube and forming a central portion or flange 1610 between the first and second end portions 1604, 1606. The rivet 1600 can be assembled onto two struts 1410, 1420 by deforming the end portions 1604, 1606, as previously described.

[0180] Figures 41 - 44 illustrate an assembly of another embodiment of a frame 1700 for an artificial heart valve. As shown in Figure 43, in the illustrated embodiment, the frame 1700 is formed from at least two separate frame sub - assemblies, a first inner frame sub - assembly 1710 (shown in Figure 41) and a second outer frame sub - assembly 1720 (shown in Figure 42), as further described herein. The two frame sub - assemblies can be further connected to each other and can be expanded using a plurality of actuators 1730, which are also described in more detail herein. In other embodiments, the frame 1700 can include additional frame sub - assemblies positioned radially inwards and / or outwards of the frame sub - assemblies 1710, 1720.

[0181] Similar to the frame 1100 shown in FIG. 21, the inner frame subassembly 1710 (best shown in FIG. 41) can include a plurality of inner struts 1712 and a plurality of outer struts 1714, and the plurality of inner struts 1712 and the plurality of outer struts 1714 are connected by hinge protrusions 1716 passing through an aperture 1718 at a joint 1715. In an alternative embodiment (not shown), the struts can be woven together as in the embodiment of FIG. 13. In other alternative embodiments, rather than using integral protrusions and apertures, the inner struts 1712 and the outer struts 1714 can be assembled using rivets at the apex 1711 and / or can be assembled by using rivets at some or all of the joints 1715. In some embodiments, separate hinges such as those shown in FIGS. 30A-33, or other separate hinges such as those shown in FIGS. 34-40C, or other suitable separate hinges can be used.

[0182] The component forming the hinge protrusion 1716 can be integrated into the strut structure. As best shown in FIG. 41, for example, three inner struts 1712 and three outer struts 1714 each include a plurality of integral hinge protrusions 1716, and the plurality of integral hinge protrusions 1716 are spaced along the length of the strut, including at the location of the joint 1715, which can be similar to the hinge protrusion 1112 shown in FIG. 25. Additional hinge protrusions 1716 can be provided at additional locations along the strut, which can be used to join the inner frame sub-assembly 1710 to the outer frame sub-assembly 1720 at the joint 1735. The outer strut 1714 can further be formed with a plurality of openings or apertures 1718 spaced along the length of the strut at the location of the joint 1715, which can be similar to the aperture 1122 as shown in FIG. 24, and which can be used to join the inner strut 1710 to the outer strut 1714 by a process similar to that described above with respect to the frame 1100.

[0183] Similar to the inner frame subassembly 1710, the outer frame subassembly 1720 (best shown in FIG. 42) can include a plurality of inner struts 1722 and a plurality of outer struts 1724, and the plurality of inner struts 1722 and the plurality of outer struts 1724 are connected by hinge protrusions 1726 of the inner struts 1722 that pass through apertures 1728 of the outer struts 1724 at the joints 1725. In an alternative embodiment (not shown), the struts can be woven together as in the embodiment of FIG. 13. In other alternative embodiments, rather than using integral hinges and apertures, the inner struts 1722 and the outer struts 1724 can be assembled using rivets or other connection mechanisms described herein, and in other patents and applications referenced herein, can be assembled at the apex 1711 and / or at some or all of the joints 1725. In some embodiments, separate hinges such as those shown in FIGS. 30A-33, or other separate hinges such as those shown in FIGS. 34-40C, or other suitable separate hinges can be used.

[0184] The component forming the hinge protrusion 1726 can be integrated into the strut structure. As best shown in FIG. 42, for example, three inner struts 1722 and three outer struts 1724 each include a plurality of integral hinge protrusions 1726, and the plurality of integral hinge protrusions 1726 are spaced along the length of the strut, including at the location of the joint 1725, which can be similar to the hinge protrusion 1112 shown in FIG. 25. The outer strut 1724 can further be formed with a plurality of openings or apertures 1728 spaced along the length of the strut at the location of the joint 1725, which can be similar to the aperture 1122 as shown in FIG. 24 and can be used to join the inner strut 1722 to the outer strut 1724 by a process similar to that described above with respect to the frame 1100. Additional apertures 1728 can be provided at additional locations along the strut, which can be used to join the outer frame subassembly 1720 to the inner frame subassembly 1710 at the joint 1735.

[0185] Each strut of the subassembly is arranged to form a plurality of closed cells (in the illustrated embodiment, each subassembly forms three diamond-shaped cells), which helps maintain their pre-assembled annular shape before being attached to each other. When assembled separately as shown in FIGS. 41 and 42, the inner frame subassembly 1710 can be inserted into the outer frame subassembly 1720. For example, the frame is rotated by a half-cell shift (60 degrees in this case) as shown in FIG. 43, and the hinge protrusions 1716 on the struts 1712, 1714 of the inner frame subassembly 1710 are inserted through the corresponding apertures 1728 in the struts 1722, 1724 of the outer frame subassembly 1720, and are joined at the joint 1735. FIG. 44 shows the assembled frame 1700, with the dotted pattern added to the struts of the inner frame subassembly 1710 for illustrative purposes only. The dotted pattern is added to distinguish the inner frame subassembly 1710 from the outer frame subassembly 1720 and does not represent an actual surface finish.

[0186] Alternatively, the hinge protrusions on the outer frame assembly can be inserted through the apertures on the inner frame assembly (in the case of an embodiment where the hinge protrusions extend radially inwards from the struts to which they are connected). Or, separate rivets or other connection mechanisms, such as those described herein, as well as those described in the patents and applications referenced herein, etc., can pass through the apertures in both subassemblies at the joint. Or, a combination of suitable connection mechanisms, including those described herein, can be used.

[0187] One or more of struts 1712, 1714 of the inner frame subassembly 1710 and one or more of struts 1722, 1724 of the outer frame subassembly 1720 can be formed with openings or apertures 1740 spaced along the length of the struts. The apertures 1740 can be used to stitch a valve tip, inner skirt, and / or outer skirt to a selected strut of the frame, as further described below.

[0188] Frame 1700 can include a plurality of actuators, the plurality of actuators can be threaded actuators 1730, and the threaded actuators 1730 are configured to expand and contract the frame radially and to hold the frame in an expanded shape when placed inside a patient's body. Each actuator 1730 can include an inner member in the form of a screw 1732, the screw 1732 can include an external thread, and the screw 1732 extends through a first outer member, sleeve, or cylinder 1734 into a second outer member, sleeve, or cylinder 1736. The first outer member, sleeve, or cylinder 1734 is positioned at a joint 1725 at one end of the outer frame subassembly 1720, and the second outer member, sleeve, or cylinder 1736 can be positioned at a joint 1715 on the inner frame subassembly 1710. One or both of these outer members 1734, 1736 can have an internal thread and can engage the inner member 1732 in a threaded manner. Also, the outer members 1734, 1736 can be attached at other locations on the frame 1700. For example, the first outer member 1734 can be attached on the inner frame subassembly 1710, and the second outer member 1736 can be attached on the outer frame subassembly 1720. Or, alternatively, both outer members 1734, 1736 can be attached on the inner frame subassembly 1710, or both outer members 1734, 1736 can be attached on the outer frame subassembly 1720.

[0189] The rotational movement of the inner member 1732 relative to the outer members 1734, 1736 is effective in expanding and compressing the frame 1700 in the radial direction. The actuator 1730 can be releasably connected to a corresponding actuator of the delivery device. For example, each screw 1732 can be releasably connected to a corresponding drive shaft or drive wire of the delivery device. Further details of the actuator 1730 are disclosed in co-pending application Ser. No. 15 / 831,197, filed Dec. 4, 2017. In other embodiments, the actuator for expanding and compressing the frame 1700 in the radial direction can be a push-pull type actuator, as previously described in connection with the embodiments of FIGS. 1, 8, 12, and 21.

[0190] In the assembled state of the frame 1700, a plurality of hinge protrusions 1716, 1726 extend through corresponding apertures 1718, 1728. During assembly, the protrusions are aligned with the apertures, and then the struts are rotated relative to each other, which rotates the protrusions relative to the apertures and fixes the struts of the inner frame subassembly and the outer frame subassembly together, as described above in connection with the method of assembling the frame 1100 described with reference to FIGS. 27-28. In an alternative embodiment, not all joints between the struts have hinge protrusions inserted through the apertures, but the inner struts and the outer struts of each frame subassembly are connected at least at the apexes, for example, at the apex 1711 of the inner frame subassembly (best shown in FIG. 41).

[0191] After assembling the frame 1700, the actuator 1730 can then be mounted on the frame. In other embodiments, the outer sleeves 1734, 1736 of the actuator can be mounted on the frame sub-assemblies 1720, 1710, respectively, before assembling the inner and outer frame sub-assemblies, and the screw 1732 is added after assembling the inner and outer frame sub-assemblies. The actuator 1730 is configured to expand and compress the frame radially as described above, but desirably within a range of a predetermined diameter and within a range of a predetermined angle between the struts of the inner frame sub-assembly 1710 and the struts of the outer frame sub-assembly 1720, limit the radial expansion and compression of the frame, and prevent the separation of the two sub-assemblies at the joint 1735, similar to the process described above with respect to the frame 1100, making the frame 1700 a "self-locking" frame assembly.

[0192] Soft components of the artificial valve, such as the valve tip or the inner skirt (not shown), can be added to the inner frame sub-assembly 1710, while other soft components, such as the outer skirt (not shown), can be added to the outer frame sub-assembly 1720. In certain embodiments, the valve tip and / or the inner skirt can be mounted or assembled onto the inner frame sub-assembly 1710 and / or the outer skirt can be mounted or assembled onto the outer frame sub-assembly 1720 before the inner frame sub-assembly 1710 and the outer frame sub-assembly 1720 are connected to each other to form the fully assembled frame 1700. Forming separate inner and outer frame sub-assemblies is advantageous in facilitating the assembly of the valve tip and / or skirt of the artificial valve, as further described below. Additional details regarding the assembly of soft components to the frame sub-assemblies are described below. In alternative embodiments, the frame 1700 can be fully assembled before assembling the valve tip and skirt to the frame 1700.

[0193] Figures 45-47 illustrate a valve sub-assembly 1900 according to another embodiment. As shown in Figure 45, the valve sub-assembly 1900 includes an inner frame sub-assembly 1710 and an artificial valve tip assembly 1910, and the artificial valve tip assembly 1910 is at least partially mounted on the inner frame sub-assembly 1710. The outer frame sub-assembly 1720 can be installed around the inner frame sub-assembly 1710 as previously described in connection with Figures 43-44.

[0194] The valve tip assembly can include three valve tips 1912 (similar to the illustrated embodiment), although it should be understood that other numbers of valve tips may also be used. Each valve tip 1912 can be formed with an interconnect tab 1914 on the opposite side portion of the valve tip. Each interconnect tab 1914 can be paired with an adjacent interconnect tab 1914 of an adjacent valve tip to form an interconnect 1930. The interconnect 1930 can be attached, for example, to a strut of the outer frame subassembly 1720 or to a component of the actuator 1730 (such as the sleeve 1734). Further details regarding attaching the valve tip interconnect 1930 to the frame are disclosed in U.S. Provisional Application No. 62 / 506,430, filed May 15, 2017, and U.S. Provisional Application No. 62 / 614,299, filed Jan. 5, 2018, and U.S. Application No. 15 / 978,459, filed May 14, 2018.

[0195] The lower or inflow portion of the leaflet tip can include a scalloped inflow or cusp edge 1920, which can be attached to the lower portions of the inner strut 1712 and the outer strut 1714, for example, by suturing or other suitable techniques. For example, the inflow edge 1920 can be sewn to the struts 1712, 1714 by a suture passing through the openings 1740 in the leaflet tip and the struts 1712, 1714, using, for example, in-and-out stitching or whip stitching extending along the struts. Alternatively, the suture can pass through the leaflet tip and around the struts 1712, 1714. The inner skirt 1940 (discussed further below) can be used to reinforce the attachment of the leaflet inflow edge 1920 to the struts 1712, 1714. One or more narrow reinforcing strips (e.g., narrow strips of fabric) can be placed along the cusp edge 1920 of each leaflet tip and sewn thereto to reinforce the connection between the cusp edge and the strut. For example, the cusp edge 1920 can be "sandwiched" or disposed between two reinforcing strips that can be sewn to each other and to the cusp edge.

[0196] In the illustrated embodiment, since the inflow edge 1920 of the valve tip 1912 is attached to the inner frame sub-assembly 1710 alone, the fixed valve tip edge does not need to pass over the "crossing strut". In other words, each inflow edge 1920 of the valve tip is fixed along the lengths of the two struts at a location where the two struts do not cross another strut at the joint 1715. As best shown in FIG. 45, in the illustrated embodiment, each inflow edge 1920 is between the joint 1715a at the apex formed by the intersection of the struts 1712, 1714 and the joints 1715b, 1715c formed by the intersections of the respective struts 1712, 1714, along the lower half of the strut, fixed to the first strut 1712 and the second strut 1714, such that the adjacent crossing struts do not pass over the joints 1715b, 1715c. Further, when the outer frame sub-assembly 1720 is attached to the inner frame sub-assembly 1710 in the manner shown in FIGS. 43-44, the outer frame sub-assembly 1720 is completely external to the connection between the inflow edges of the valve tips, and the struts of the outer frame sub-assembly do not need to be used for the attachment of the inflow edges 1920 of the valve tips.

[0197] Avoiding attachment of the tip inflow edge to any crossing strut provides a more robust tip connection, with less stress being applied to the tip between the inflow edge 1920 and the junction tab 1912. Additionally, this manner of connecting the tip to the strut reduces the risk of tip wear, provides a symmetric and smooth attachment line, and improves valve performance. Moreover, due to the fact that the inner frame subassembly has fewer struts than a fully formed frame, it is relatively easy to secure the tip to struts 1712, 1714 before fully assembling the frame, and thus there is much more access to the interior of the frame for assemblers to insert tools and their fingers during the assembly process. This greatly simplifies the process of sewing the tip to the struts and / or any reinforcing strips or skirts.

[0198] Figure 46 shows one way of attaching the inner skirt 1940 to the valve subassembly 1900. In the illustrated embodiment, the inner skirt 1940 is "sandwiched" or disposed between the inner strut 1712 and the outer strut 1714 of the inner frame subassembly 1710. As such, the connection of the inner strut 1712 and the outer strut 1714 at the junction 1715 can be used to help secure the skirt to the inner frame subassembly 1710, for example, by passing the protrusion 1716 through a corresponding slit or opening in the skirt. The skirt 1940 can be further secured to the struts 1712, 1714 by stitching, with the stitching passing through the skirt and through (and / or around) the apertures 1740 of the selected struts 1712, 1714. The skirt 1940 can be formed with a wavy outflow edge 1942, which is shaped to correspond to a circumferential row of strut segments adjacent to a row of strut segments that define the outflow end of the frame assembly.

[0199] In another embodiment, as shown in FIG. 47, the inner skirt 1940 is mounted completely externally of the inner frame subassembly 1710. The skirt 1940 can be fixed to the struts 1712, 1714 of the inner frame subassembly 1710 by sutures that extend through the apertures 1740 and / or that extend around selected struts of the inner frame subassembly 1710.

[0200] FIG. 48 illustrates another exemplary artificial valve 2000. The artificial valve 2000 can be formed by first assembling the valve subassembly 1900 of FIG. 47 with the inner skirt 1940 provided completely externally of the inner frame subassembly 1710. Then, the outer frame assembly 1720 can be formed and installed around the skirt 1940 and can be fixed to the inner frame subassembly 1710 as previously described in connection with FIGS. 43-44, except that instead of or in addition to the sutures used to fix the skirt 1940 to the struts of the frame, the connection between the inner frame subassembly 1710 and the outer frame subassembly 1720 at the joint 1735 can be used to fix the inner skirt 1940 to the frame 1700. In particular, the skirt 1940 can be held in place by inserting a protrusion 1716 of the inner frame subassembly 1710 that extends through an aperture 1728 of the outer frame subassembly 1720 through a slit or opening in the skirt. In this way, selected protrusions 1716 of the inner frame subassembly 1710 extend through respective slits or openings in the skirt 1940 and through respective openings 1728 in the outer frame subassembly 1720.

[0201] In an alternative embodiment where separate rivets or hinge members are used instead of an integral protrusion 1716 (such as those shown in FIGS. 29-40), one or more rivets or hinge members can extend through an opening in a strut of the inner frame sub-assembly 1710, through a slit or opening in the skirt 1940, and through an opening in a strut of the outer frame sub-assembly 1720.

[0202] In this way, the inner skirt 1940 can be sandwiched or held between the inner and outer struts of the inner frame sub-assembly 1710 (FIG. 46), or between the inner frame sub-assembly 1710 and the outer frame sub-assembly 1720 (FIG. 48), providing a strong and durable connection for the inner skirt 1940. In yet other embodiments, the skirt 1940 can be disposed between the inner and outer struts of the outer frame sub-assembly 1720 and held in place with the protrusion of the inner strut extending through a slit or opening in the skirt.

[0203] This configuration of connecting the skirt to the frame can simplify the assembly process and potentially reduce the amount of sewing by using protrusions, rivets, hinges, or other connection mechanisms themselves to connect the skirt to the struts of the frame. In particular, positioning the skirt 1940 between the inner and outer frame sub-assemblies 1710, 1720 after forming each of the frame sub-assemblies can save a significant amount of time when assembling the entire valve. Additionally, in some embodiments, the entire skirt can be fixed to the frame via protrusions on the struts (or other hinge mechanisms) without the use of stitching threads. Additionally, using the relative positions of the protrusions, rivets, hinges, or other connection mechanisms to fix the two frame sub-assemblies at the joint 1735 and to connect the inner skirt 1940 to the frame sub-assembly allows these connection mechanisms at the joint 1735 to serve as self-aligning features for the frame components and the soft components. The reason is that each protrusion (or other hinge member) aligns with a pre-formed slit or opening in the soft component (e.g., the skirt 1940). In other words, the spacing and positioning of the pre-formed slits or openings in the soft component correspond to the spacing and positioning of the protrusions on the strut, facilitating proper positioning of the soft component relative to the frame strut during the assembly process.

[0204] The prosthetic valve 2000 can further include an outer skirt (not shown), which can be positioned entirely outside the outer frame sub-assembly 1720. The outer skirt can be fixed to the frame using stitching threads and / or hinge members that fix the inner and outer struts of the outer frame sub-assembly 1720.

[0205] Another further advantage provided by the prosthetic valve 2000 is that the outer frame sub-assembly 1720 is assembled separately and in a state completely positioned externally to the inner frame sub-assembly 1710, and a strut (for example, a strut positioned at a position where the valve tip of the valve tip assembly is moved toward and away from the frame) facing the articulating portion of the valve tip is part of the outer frame sub-assembly 1720. This is to create a gap between the articulating portions of the valve tips (especially the joining edges) and to prevent or minimize contact between the valve tip and the frame during the operation of the prosthetic valve, thereby protecting against valve tip wear. Also, this can enable the use of relatively large valve tips for improved hemodynamics.

[0206] In an alternative embodiment, the valve tip 1912 or a portion thereof can be fixed to the struts of the frame in a similar manner using one or more hinge members that extend through the valve tip and two overlapping struts instead of or in addition to suture attachment of the valve tip. In one implementation, for example, the inflow edge 1920 of the valve tip can be positioned against the inner surfaces of the struts 1712, 1714 held in place by a hinge member (e.g., a rivet) that extends through the valve tip, the struts 1712, 1714, and the struts 1722, 1724 of the outer frame. In another implementation, the valve tip 1912 can be installed between the inner and outer struts 1712, 1714 at the joints 1715a, 1715b, 1715c and can be held in place via a protrusion 1716 (or other hinge member) that interconnects the struts at those joints.

[0207] Figures 49 to 52 illustrate another embodiment of the frame assembly 2100 for an artificial valve. The frame assembly 2100 can be used when a relatively larger frame is desired. The frame assembly 2100 can be formed from an inner frame sub-assembly 2110 (Figure 49) and an outer frame sub-assembly 2120 (Figure 50). As shown in Figure 51, the frame assembly 2100 has a "9x3" configuration, which is formed from nine struts positioned in a first direction and nine crossing struts positioned in a second direction. Similar to what has been described above, each strut is connected to another strut and forms a vertex at each of its ends, and each strut is also connected to one or more additional struts between its ends to form joints.

[0208] Figure 49 shows the inner frame sub-assembly 2110 away from the outer frame sub-assembly 2120. As best shown in Figure 49, the inner frame sub-assembly 2110 can be similar to the inner frame sub-assembly 1710, with three inner struts 2112 oriented in a first direction and three crossing outer struts 2114 oriented in a second direction. The inner struts 2112 and the outer struts 2114 can be joined to each other at their ends to form vertexes 2111, and can also be joined at joints 2115 positioned between the ends of the struts. These joints can be formed using any of the methods and / or mechanisms described herein and in the patents and applications referenced and described.

[0209] Figure 50 shows the outer frame sub-assembly 2120 away from the inner frame sub-assembly 2110. Except that, as best shown in Figure 50, instead of three inner struts and three crossing outer struts, the outer frame sub-assembly 2120 includes six inner struts 2122 oriented in a first direction and six crossing outer struts 2124 oriented in a second direction, the outer frame sub-assembly 2120 is similar to the outer frame sub-assembly 1720. The inner struts 2122 and the outer struts 2124 can be joined to each other at their ends to form apex portions 2121 and can also be joined at joints 2125 positioned between the ends of the struts. These joints can be formed using any of the methods and / or mechanisms described herein and in the patents and applications referenced and described in the patents and applications referred to herein.

[0210] Figure 51 shows the inner frame sub-assembly 2110 assembled with the outer frame sub-assembly 2120. As shown in Figure 51, when assembled separately, the inner frame sub-assembly 2110 can be inserted into the outer frame sub-assembly 2120 and can also be joined at joint 2135 using any of the methods and / or mechanisms described herein and in the patents and applications referenced and described in the patents and applications referred to herein. Dotted lines have been added to the struts of the inner frame sub-assembly 2110 for purposes of illustration only. The dotted lines are added to distinguish the inner frame sub-assembly 2110 from the outer frame sub-assembly 2120 and do not represent an actual surface finish.

[0211] Additionally, as shown in FIG. 52, two sub-assemblies may be further connected to each other via a plurality of actuators 2130. In the illustrated embodiment, the actuator 2130 is a screw actuator, and the screw actuator is similar in construction and function to the screw actuator 1730. In the illustrated embodiment, similar to the actuator 1730, each actuator 2130 includes a screw 2132 that extends through an upper outer member or sleeve 2134 and a lower outer member or sleeve 2136. Rotation of the screw 2132 is effective to radially expand or compress the frame assembly 2100, as previously described. In other embodiments, the actuator may be any of the push-pull type actuators as previously described in connection with the embodiments of FIGS. 1, 8, 12, and 21, and / or any of the various actuators described in the referenced patents and / or applications.

[0212] Additionally, a pair of commissure attachment members 2140 can be attached to the upper end portions of the respective actuators 2130. Each pair of commissure attachment members 2140 can extend from side portions that face diametrically the upper sleeve 2134 of the actuator 2130. Each pair of commissure attachment members 2140 can be used to secure a pair of commissure tabs 1914 (FIG. 46) of the valve tip assembly. By placing the commissure tabs 1914 against the commissure attachment members 2140 and suturing the commissure tabs 1914 in place against the commissure attachment members 2140, each commissure tab 1914 of the valve tip 1912 can be secured to the respective commissure attachment member 2140. The suture thread can extend through the commissure tabs 1914 and through an opening 2142 in the commissure attachment member 2140. The inflow edge of the valve tip can be secured to the struts 2112, 2114 of the inner frame subassembly as described above in connection with FIG. 45. A skirt (e.g., skirt 1940) can be secured to the frame assembly 2100 as previously described in connection with the embodiments of FIGS. 46-48.

[0213] General Considerations The disclosed embodiments can be adapted for use with an artificial device that can be implanted into any of the heart's natural valve annuli (e.g., pulmonary valve annulus, mitral valve annulus, and tricuspid valve annulus) and can be used with any of a variety of delivery approaches (e.g., retrograde, antegrade, transseptal, transventricular, transatrial, etc.). It should also be understood that the disclosed embodiments can be used with a prosthesis implanted in other lumens of the body.

[0214] For the purposes of this description, certain aspects, advantages, and novel features of embodiments of the present disclosure are described herein. The disclosed methods, apparatuses, and systems should in no way be construed as limiting. Instead, the present disclosure relates to all novel and non-obvious features and aspects of the various disclosed embodiments, alone and in various combinations and sub-combinations with each other. The methods, apparatuses, and systems are not limited to any particular aspect or feature or combination thereof, and the disclosed embodiments are not required to have any one or more particular advantages or to solve any problems. The techniques from any example can be combined with the techniques described in any one or more of the other examples. Considering the many potential embodiments to which the principles of the disclosed techniques can be applied, it should be recognized that the illustrated embodiments are merely preferred examples and should not be taken as limiting the scope of the disclosed techniques.

[0215] Although some of the operations of the disclosed embodiments are described in a particular sequential order for convenience of presentation, it should be understood that this presentation style encompasses rearrangement, unless a particular ordering is required by the specific language described below. For example, operations described sequentially may in some cases be rearranged or performed concurrently. Additionally, for simplicity, the accompanying figures may not show the various ways in which the disclosed method can be used in relation to other methods. Additionally, the description may use terms such as "provide" or "implement" to describe the disclosed method. These terms are a high-level abstraction of the actual operations being performed. The actual operations corresponding to these terms can vary depending on the particular implementation and can be readily identified by one of ordinary skill in the art.

[0216] As used herein and in the claims, the singular forms "a", "an", and "the" include the plural unless the context clearly dictates otherwise. Additionally, the term "includes" means "comprises". Further, the terms "coupled" and "associated" generally mean electrically, electromagnetically, and / or physically (e.g., mechanically or chemically) coupled or linked, and without specific contrary language, do not exclude the presence of intermediate elements between the items that are coupled or associated.

[0217] As used herein, the term "proximal" refers to the position, orientation, or part of the device that is closer to the user and farther from the implantation site. As used herein, the term "distal" refers to the position, orientation, or part of the device that is farther from the user and closer to the implantation site. Thus, for example, proximal movement of the device is movement of the device toward the user, while distal movement of the device is movement of the device away from the user. The terms "longitudinal" and "axial" refer to an axis extending in the proximal and distal directions unless explicitly defined otherwise.

[0218] As used herein, actions that occur "simultaneously" or "concurrently" generally occur at the same time as each other, but a delay in the occurrence of one action relative to the other, due to, for example, the spacing, play, or backlash between components in a mechanical linkage (e.g., threads, gears, etc.), is within the scope of the above terms unless explicitly stated to the contrary.

[0219] Considering the many potential embodiments to which the principles of the present disclosure may be applied, it should be recognized that the illustrated embodiments are merely preferred examples and should not be taken as limiting the scope of the present disclosure. Rather, the scope of the present disclosure is defined by the following claims.

Explanation of Reference Numerals

[0220] 10 Artificial implant delivery assembly 14 Artificial heart valve 18 Delivery device 22 Frame 24 Valve structure 26 Inflow end portion 28 Intermediate portion 30 Outflow end portion 32 Lattice strut 32a Inner strut 32b Outer strut 34 Apex portion 36 Aperture 37 Countersink hole 38 Aperture 40 Fastener 41 Head portion 42 Support strut 46 Spacer 48 Valve tip assembly 50 Skirt 56 Suture 60 Distal end 62 Proximal end 70 Handle 72 Shaft 76 Positioning member 78 Distal end 82 Distal end portion 86 Second actuating member 88 Proximal end portion 94 Release-and-locking unit 96 Body portion 98 Clamp 100 Distal end 102 Joe 106 Release member 107 Distal end portion 108 Proximal end portion 110 Distal end portion 112 Connecting portion 114 Tab 116 Notch 120 Notch 122 Tab 124 Cam surface 126 Cam surface 128 Slot 130 Fastener 132 Aperture 134 Arrow 136 Arrow 138 Bore 140 Proximal end 142 Central bore 144 Lead screw 148 Threaded actuator nut 150 Thread 152 Outer surface 154 Aperture or window 156 Outer surface 158 Ridge portion 160 Extension portion 162 Leg portion 164 U-shaped aperture or slot 168 Release knob 170 Slidable member 172 User-engageable portion 178 Bore or opening 180 Proximal end portion 182 Clamping member, clamping mechanism, retaining mechanism 184 Plug member 186 Screw member 188 Knob 190 Radial bore 192 Surface 194 Captured nut 200 Frame 204 Lattice strut 204a Inner strut 204b Outer Strut 208 Aperture 210 Fastener 214 Imaginary Line 218 Linear Segment 220 Intermediate Segment 224 Enlarged End Portion 226a Longitudinal Edge 226b Longitudinal Edge 228 Rounded Edge 250 Open Cell 254 Pivot Joint 256 Gap 264 Valve Tip Assembly 266 Skirt 270 Suture

Claims

[Claim 1] A medical device as described in the specification and drawings.

Images