Prosthetic heart valve with non-linear struts - Patents.com

Abstract

The implantable prosthesis can include a frame that is radially expandable and compressible between a radially compressed configuration and a radially expanded configuration. The frame can include a plurality of struts, each strut including a first portion and a second portion separated by a deflection point. Each strut can be helically curved relative to a first longitudinal axis of the frame. The first portion of each strut can be curved in a first direction relative to a first line parallel to a second axis that is perpendicular to the first longitudinal axis of the frame, and the second portion of each strut can be curved in a second direction relative to a second line parallel to the second axis.

Description

[Technical field]

[0001] [CROSS REFERENCE TO RELATED APPLICATIONS] This application claims the benefit of U.S. Provisional Application No. 63 / 094,459, filed October 21, 2020, and U.S. Provisional Application No. 62 / 945,000, filed December 6, 2019, both of which are incorporated by reference in their entireties herein.

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

[0003] The human heart can suffer from a variety of valvular diseases. These valvular diseases can result in significant malfunction of the heart, ultimately requiring repair of the native valve or replacement of the native valve with a prosthetic valve. There are several known repair devices (e.g., stents) and prosthetic valves, as well as several known methods of implanting these devices and valves in a person. Percutaneous and minimally invasive surgical approaches are used in a variety of procedures to deliver prosthetic medical devices to locations within the body that are not easily accessible by surgery or where access without surgery is desirable. In one specific example, a prosthetic heart valve can be attached to the distal end of a delivery device in a crimped state and advanced through the patient's vasculature (e.g., through the femoral artery and aorta) until the prosthetic heart valve reaches an implantation site within the heart. The prosthetic heart valve is then expanded to its functional size, for example, by inflating a balloon to which the prosthetic valve is attached, by activating a mechanical actuator that applies an expansion force to the prosthetic heart valve, or by deploying the prosthetic heart valve from a sheath of the delivery device so that the prosthetic heart valve can self-expand to its functional size.

[0004] Prosthetic heart valves that rely on a mechanical actuator for expansion can be referred to as "mechanically expandable" prosthetic heart valves. Mechanically expandable prosthetic heart valves can provide one or more advantages over self-expanding and balloon-expandable prosthetic heart valves. For example, mechanically expandable prosthetic heart valves can be expanded to a variety of diameters. Mechanically expandable prosthetic heart valves can also be compressed after initial expansion (e.g., for repositioning and / or retrieval). During expansion and compression of the prosthetic valve, and during normal use of the prosthetic valve, various forces can act on the frame that can deform or bend the frame. Summary of the Invention [Problem to be solved by the invention]

[0005] Thus, a need exists for improved prosthetic heart valve frame designs and methods for implantation. [Means for solving the problem]

[0006] Described herein are embodiments of improved implantable medical devices, such as prosthetic heart valves, as well as methods for implanting such devices.

[0007] In one exemplary embodiment, an implantable prosthesis can include a frame that is radially expandable and compressible between a radially compressed configuration and a radially expanded configuration. The frame can include a plurality of struts, each strut including a first portion and a second portion separated by a deflection point. Each strut can be curved helically relative to a first longitudinal axis of the frame. The first portion of each strut can be curved in a first direction relative to a first line parallel to a second axis that is perpendicular to the first longitudinal axis of the frame, and the second portion of each strut can be curved in a second direction relative to a second line parallel to the second axis.

[0008] In another exemplary embodiment, an implantable prosthesis includes a frame having first and second opposing axial ends, the frame including a plurality of medial and lateral struts pivotally coupled to one another at a plurality of joints, each strut having a first portion and a second portion, the first portion forming a convex curve facing the first end of the frame and the second portion forming a concave curve facing the first end of the frame.

[0009] In one exemplary embodiment, an implantable prosthesis includes a radially expandable and compressible frame having an inflow end and an outflow end. The frame can include a plurality of first struts extending in a first direction and a plurality of second struts extending in a second direction. The second struts can be coupled to the first plurality of struts at a plurality of joints, a first set of selected joints configured as fixed joints and a second set of selected joints configured as pivotable joints. Each fixed joint can include a fastener configured to couple the respective first and second struts to one another, such that the respective first and second struts can pivot relative to one another about the fastener, and each pivotable joint can include a protrusion extending from a surface of the respective second strut, the protrusion being disposed within a corresponding recess in the surface of the respective first strut such that the respective first and second struts can pivot relative to one another about the protrusion.

[0010] In another exemplary embodiment, an implantable prosthesis can include a radially expandable and compressible frame having an inflow end and an outflow end. The frame can include a plurality of first struts extending in a first direction and a plurality of second struts extending in a second direction and coupled to the plurality of first struts at a plurality of joints. Each first strut can include a plurality of linear segments coupled to one or more adjacent linear segments via one or more intermediate segments, each first strut can include at least one aperture extending through the thickness of the first strut at the intermediate segment and at least one recess extending into the thickness of the first strut at an additional intermediate segment. Each second strut can include a plurality of linear segments coupled to one or more adjacent linear segments via one or more intermediate segments, each second strut can further include at least one fastener extending from a surface of the strut at the intermediate segment and at least one protrusion extending from a surface of the strut at the additional intermediate segment. Selected joints of the plurality of joints may be configured as fixed joints and selected joints may be configured as pivotable joints.

[0011] In another exemplary embodiment, an implantable prosthesis can include a radially expandable and compressible frame having an inflow end and an outflow end, the frame can include a plurality of first struts extending in a first direction, each first strut including at least one first aperture extending through a thickness of the first strut and a first recess disposed about the first aperture, and a plurality of second struts extending in a second direction, each second strut including at least one second aperture extending through a thickness of the second strut and a second recess disposed about the second aperture. The frame may further include a plurality of fasteners, each fastener extending through a respective first opening and a respective second opening to couple a respective first and second post to one another at a joint, each fastener including a body portion, a head portion sized to retain the fastener in the second recess, and a flanged end sized to retain the fastener in the first recess.

[0012] In one exemplary embodiment, a method can include inserting a fastener through a first opening in a first strut and a second opening in a second strut, the fastener including a body portion having a first diameter, a head portion having a second diameter larger than the first diameter, and an end portion, and disposing the head portion of the fastener in a recess surrounding the second opening, the recess being disposed on a radially inner surface of the second strut. The method can further include deforming the end portion of the fastener to form a flanged head portion disposed in an additional recess surrounding the first opening and coupling the first and second struts to one another, such that the first and second struts can pivot relative to one another about the fastener.

[0013] In another exemplary embodiment, an implantable prosthesis can include a radially expandable and compressible frame having an inflow end and an outflow end. The frame can include a plurality of first struts extending in a first direction, each first strut including at least one aperture extending through a thickness of the first strut and a recess disposed about the aperture, and a plurality of second struts extending in a second direction, each second strut including at least one fastener extending from a surface of the second strut. Each fastener can extend through a respective aperture to couple a respective first and second strut to one another at a joint, each fastener including a body portion and a flanged end sized to retain the fastener within the recess.

[0014] In one exemplary embodiment, a method includes inserting a fastener through an opening in a first post, the fastener extending from a radially outer surface of the second post, and deforming an end of the fastener to form a flanged head portion disposed in a recess surrounding the opening and joining the first and second posts to one another, the recess being disposed in the radially outer surface of the first post, such that the first and second posts can pivot relative to one another about the fastener.

[0015] In one representative embodiment, an implantable prosthesis can include a radially expandable and compressible frame having an inflow end and an outflow end. The frame can include a plurality of first struts extending in a first direction, each first strut including at least one aperture extending through a thickness of the first strut and a recess disposed about the aperture, and a plurality of second struts extending in a second direction, each second strut including at least one fastener extending from a surface of the second strut through a respective aperture in the first strut. Each fastener can include a body portion, a projection, and an internal slot extending at least partially along the length of the fastener, the fastener being movable between a compressed configuration and an uncompressed configuration. When in the uncompressed configuration, the projection is sized to retain the fastener within the respective aperture to couple the first and second struts to one another and to allow the first and second struts to pivot relative to one another about the fastener.

[0016] In one exemplary embodiment, the method can include pressing a fastener against an aperture in a first strut, the fastener extending from a radially outer surface of the second strut and including a body portion, a protrusion, and an internal slot extending at least partially along a length of the fastener, the protrusion having a diameter greater than a diameter of the aperture, and advancing the fastener through the aperture such that the fastener moves from an uncompressed configuration to a compressed configuration. The method can further include allowing the fastener to resiliently expand to the uncompressed configuration such that once the protrusion emerges from a radially outer end of the aperture, the fastener is retained within the aperture such that the first and second struts can pivot relative to one another about the fastener, coupling the first and second struts to one another.

[0017] The foregoing and other objects, features, and advantages of the present disclosure will become more apparent from the following detailed description, which proceeds with reference to the accompanying drawings. [Brief description of the drawings]

[0018] [Figure 1] FIG. 1 is a perspective view of a prosthetic heart valve, according to one embodiment. [Figure 2A] 2 is a side elevational view of the frame of the prosthetic heart valve of FIG. 1 shown in a radially compressed state. [Figure 2B] 2 is a side elevational view of the frame of the prosthetic heart valve of FIG. 1 shown in a radially expanded state. [Diagram 3] FIG. 13 is a perspective view of a prosthetic valve frame shown in a radially collapsed state having multiple expansion and locking mechanisms according to another embodiment. [Figure 4] FIG. 4 is a perspective view of the frame and expansion and locking mechanism of FIG. 3, showing the frame in a radially expanded state. [Figure 5A] FIG. 4 is a perspective view of one screw of the expansion and locking mechanism of FIG. [Figure 5B] FIG. 4 is a perspective view of one of the expansion and locking mechanisms of FIG. 3. [Figure 5C] FIG. 4 is another perspective view of the frame and expansion and locking mechanism of FIG. 3, showing the frame in a radially expanded state. [Figure 6] FIG. 4 is another perspective view of one of the expansion and locking mechanisms of FIG. 3. [Figure 7] FIG. 4 is a cross-sectional view of one of the expansion and locking mechanisms of FIG. 3 along with a portion of the frame. [Figure 8] FIG. 13 is a side elevational view of a frame for a prosthetic heart valve, according to another embodiment. [Figure 9] FIG. 9 is a plan view of the struts of the frame of FIG. 8 shown in a flattened configuration. [Figure 10] FIG. 9 is a plan view of the struts of the frame of FIG. 8 shown in a flattened configuration. [Figure 11] FIG. 13 is a side elevational view of a frame for a prosthetic heart valve, according to another embodiment. [Figure 12] FIG. 1 is a perspective view of a prosthetic heart valve, according to one embodiment. [Figure 13] FIG. 13 is a perspective view of a portion of the struts of the prosthetic heart valve of FIG. 12. [Figure 14] FIG. 13 is a perspective view of an exemplary fixation joint of the prosthetic heart valve of FIG. 12. [Figure 15]13 is a partial cross-sectional perspective view of an exemplary pivotable joint of the prosthetic heart valve of FIG. 12. [Figure 16] FIG. 18 is a cross-sectional side view of the fastener of FIG. 17 joining two posts together at a joint, according to one embodiment. [Figure 17] FIG. 1 illustrates a perspective view of an exemplary fixture, according to one embodiment. [Figure 18] FIG. 18 is a cross-sectional side view of the fastener of FIG. 17 joining two posts together at a joint, according to another embodiment. [Figure 19] FIG. 13 is a cross-sectional side view of another embodiment of a fastener joining two posts together at a joint. [Figure 20] FIG. 13 is a side elevational view of the fixture during the process of radial riveting with the riveting element. [Figure 21] FIG. 13 is a cross-sectional side view of a fixture joining two posts together at a joint after a radial riveting process. [Figure 22] FIG. 2 is a perspective view of a portion of a support column according to one embodiment. [Diagram 23] FIG. 13 is a cross-sectional side elevation view of a fastener extending from a post according to one embodiment. [Figure 24] FIG. 24 is a cross-sectional side elevation view of the fastener of FIG. 23 used to join two posts together at a joint. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0019] Overall Considerations It should be understood that the disclosed embodiments can be adapted for delivering and implanting a prosthesis to any of the heart's native valve annulus (e.g., aortic, pulmonary, mitral, and tricuspid annulus) and can be used with any of a variety of delivery devices for delivering the prosthetic valve using any of a variety of delivery approaches (e.g., retrograde, antegrade, transseptal, transventricular, transatrial, etc.).

[0020] For purposes of this description, certain aspects, advantages, and novel features of the disclosed embodiments are described herein. The disclosed methods, devices, and systems should not be construed as limiting in any manner. Instead, the disclosure is directed to all novel and non-obvious features and aspects of the various disclosed embodiments, both alone and in various combinations and subcombinations with one another. These methods, devices, 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 specific advantages or to solve any problems. Techniques from any example can be combined with techniques described in any one or more of the other examples. In view of the many possible embodiments to which the principles of the disclosed technology can be applied, it should be recognized that the illustrated embodiments are merely preferred examples and should not be construed as limiting the scope of the disclosed technology.

[0021] Although some operations of the disclosed embodiments are described in a particular, sequential order for convenient presentation, it should be understood that the method of description includes rearrangements unless a particular order is required by specific language set forth herein. For example, operations described in a sequence may be rearranged or performed simultaneously in some cases. Also, for simplicity, the accompanying figures may not show the various ways in which the disclosed methods can be used in conjunction with other methods. In addition, the description sometimes uses terms such as "provide" or "achieve" to describe the disclosed methods. These terms are high-level abstractions of actual operations that are performed. The actual operations that correspond to these terms may vary depending on the particular implementation, but are readily discernible by those of ordinary skill in the art.

[0022] As used in this application and in the claims, the singular forms "a," "an," and "the" include the plural forms unless the context clearly dictates otherwise. In addition, the term "includes" means "comprises." Furthermore, the terms "coupled" and "connected" generally mean electrically, electromagnetically, and / or physically (e.g., mechanically or chemically) coupled or connected and do not exclude the presence of intermediate elements between coupled or related items, unless specifically stated to the contrary.

[0023] Directions and other relative references (e.g., inside, outside, top, bottom, etc.) may be used to facilitate discussion of the figures and principles herein, but are not intended to be limiting. For example, several terms such as "inside," "outside," "top," "bottom," "internal," "external," etc. may be used. Such terms are used, where applicable, to provide some clarity of explanation when dealing with relative relationships, particularly with respect to the illustrated embodiments. However, such terms are not intended to imply absolute relationships, positions, and / or orientations. For example, with respect to an object, a "top" part can become a "bottom" part simply by flipping the object over. Nevertheless, it is still the same part and the object remains the same. As used herein, "and / or" means "and" or "or," as well as "and" and "or."

[0024] Examples of the disclosed technology Described herein are embodiments of prosthetic implants including frames for use with prosthetic implants such as prosthetic heart or venous valves, stents, or grafts, to name a few. The disclosed frame shapes can prevent or reduce buckling or other deformation of the prosthetic valve under stress.

[0025] The prosthetic valves disclosed herein can be radially compressible and expandable between a radially compressed state and a radially expanded state. Thus, the prosthetic valve can be crimped or held by an implant delivery device in a radially compressed state during delivery and then expanded to a radially expanded state once the prosthetic valve reaches the implantation site. It is understood that the valves disclosed herein can be used with a variety of implant delivery devices, examples of which are discussed in more detail below.

[0026] 1 illustrates an exemplary prosthetic valve 10, according to one embodiment. The prosthetic valve 10 can include an annular stent or frame 12 having an inflow end 14 and an outflow end 16. The prosthetic valve 10 can also include a valve structure 18 coupled to and supported on the inside of the frame 12. The valve structure 18 is configured to regulate blood flow through the prosthetic valve 10 from the inflow end 14 to the outflow end 16.

[0027] The valve structure 18 may include a leaflet assembly including, for example, one or more leaflets 20 made of a flexible material. The leaflets 20 may be made, in whole or in part, from a biological material, a biocompatible synthetic material, or other such material. Suitable biological materials may include, for example, bovine pericardium (or pericardium from other sources). The leaflets 20 may be secured to one another on their adjacent sides to form commissures, each of which may be secured to a respective actuator 50 or frame 12.

[0028] In the illustrated embodiment, the valve structure 18 includes three leaflets 20, which may be configured to fold in a tricuspid valve configuration. Each leaflet 20 may have an inflow edge 22. As shown in FIG. 1, the inflow edge 22 of the leaflets 20 may define an undulating, curved, scalloped shape that circumferentially follows or tracks the multiple interconnected strut segments of the frame 12 when the frame 12 is in a radially expanded configuration. The inflow edge of the leaflets may be referred to as a "scallop line."

[0029] In some embodiments, the inflow edge 22 of the leaflets 20 can be sutured to the adjacent struts of the frame generally along a scalloped line. In other embodiments, the inflow edge 22 of the leaflets 20 can be sutured to an inner skirt, which is then sutured to the adjacent struts of the frame. By forming the leaflets 20 in this scalloped shape, stresses on the leaflets 20 are reduced, thereby improving the durability of the valve 10. The scalloped shape also eliminates or at least minimizes folds and ripples in the ventral area of ​​each leaflet 20 (the central area of ​​each leaflet) that can cause premature calcification in these areas. The scalloped shape also reduces the amount of tissue material used to form the valve structure 18, which allows for a smaller, more uniform crimped profile at the inflow end 14 of the valve 10.

[0030] Further details regarding transcatheter prosthetic heart valves, including methods by which the valve structures may be attached to the prosthetic valve frame, can be found, for example, in U.S. Pat. Nos. 6,730,118, 7,393,360, 7,510,575, 7,993,394, and 8,252,202, U.S. Patent Application Publication No. 2018 / 0325665, and U.S. Patent Application No. 16 / 941,776, all of which are incorporated by reference in their entireties herein.

[0031] The prosthetic valve 10 may be radially compressible and expandable between a radially compressed configuration and a radially expanded configuration. Figures 2A-2B show the bare frame 12 (without leaflets and other components) of the prosthetic valve 10 for purposes of illustrating the expansion of the prosthetic valve 10 from a radially compressed configuration (Figure 2A) to a radially expanded configuration (Figure 2B).

[0032] The frame 12 may include a plurality of interconnected lattice struts 24 arranged in a lattice-type pattern forming a plurality of apexes 34 at the outflow end 16 of the prosthetic valve 10. The struts 24 may also form similar apexes 32 at the inflow end 14 of the prosthetic valve 10. In FIG. 2B, the struts 24 are shown as being disposed at an angle, or radially offset from the axis, at an angle relative to the longitudinal axis 26 of the prosthetic valve 10 when the prosthetic valve 10 is in the expanded configuration. In other implementations, the struts 24 may be offset by a different amount than shown in FIG. 2B, or some or all of the struts 24 may be disposed parallel to the longitudinal axis 26 of the prosthetic valve 10.

[0033] The struts 24 may include a set of inner struts 24a (extending from the lower left to the upper right of the frame in FIG. 2B ) and a set of outer struts 24b (extending from the upper left to the lower right of the frame in FIG. 2B ) connected to the inner struts 24a. The open lattice structure of the frame 12 may define a plurality of open frame cells 36 between the struts 24.

[0034] The struts 24 may be pivotally coupled to one another at one or more pivot joints or junctions 28 along the length of each strut. For example, in one embodiment, each of the struts 24 may be formed with apertures 30 at opposing ends of the strut, the apertures being spaced along the length of the strut. Respective hinges may be formed where the struts 24 overlap one another via fasteners 38 (FIG. 1), such as rivets or pins, that extend through the apertures 30. The hinges may allow the struts 24 to pivot relative to one another as the frame 12 is radially expanded or compressed, for example, during assembly, preparation, or implantation of the prosthetic valve 10.

[0035] The components used to form the frame struts and pivot joints of frame 12 (or any frame described below) can be made of any of a variety of suitable materials, such as stainless steel, cobalt chromium alloy, or nickel titanium alloy ("NiTi"), e.g., Nitinol. In some embodiments, frame 12 can be constructed by forming the individual components (e.g., the frame struts and fasteners) and then mechanically assembling and connecting the individual components together. Further details regarding the construction of frames and prosthetic valves are described in U.S. Pat. No. 10,603,165, U.S. Patent Application Publication Nos. 2018 / 0344456, 2019 / 0060057, and 2020 / 0188099, all of which are incorporated herein by reference.

[0036] In the illustrated embodiment, the prosthetic valve 10 can be mechanically expanded from a radially contracted configuration to a radially expanded configuration. For example, the prosthetic valve 10 can be radially expanded by applying an axial force to the outflow end 16 toward the inflow end 14 while maintaining the inflow end 14 of the frame 12 in a fixed position. Alternatively, the prosthetic valve 10 can be expanded by maintaining the outflow end 16 in a fixed position while applying an axial force to the inflow end 14, or by applying opposing axial forces to the inflow and outflow ends 14, 16, respectively.

[0037] 1, the prosthetic valve 10 can include one or more actuators 50 attached to and spaced evenly around the inner surface of the frame 12. Each of the actuators 50 can be configured to form a releasable connection with one or more respective actuators of a delivery device.

[0038] In the illustrated embodiment, expansion and compression forces may be applied to the frame by actuators 50. Referring again to FIG. 1, each of the actuators 50 may include a screw or threaded rod 52, a first anchor in the form of a cylinder or sleeve 54, and a second anchor in the form of a threaded nut 56. The rod 52 extends through the sleeve 54 and the nut 56. The sleeve 54 may be secured to the frame 12, for example, with a fastener 38 forming a hinge at the joint between the two posts. Each actuator 50 is configured to increase the distance between the mounting locations of the respective sleeve 54 and nut 56, thereby causing the frame 12 to stretch axially and compress radially, and to decrease the distance between the mounting locations of the respective sleeve 54 and nut 56, thereby causing the frame 12 to shorten axially and expand radially.

[0039] For example, each rod 52 can have external threads that engage internal threads of a nut 56 such that rotation of the rod causes corresponding axial movement of the nut 56 toward or away from the sleeve 54 (depending on the direction of rotation of the rod 52). This causes the hinges supporting the sleeve 54 and nut 56 to move toward each other, radially expanding the frame, or move away from each other, radially compressing the frame, depending on the direction of rotation of the rod 52.

[0040] In other embodiments, the actuators 50 can be reciprocating actuators configured to apply an axial force to the frame to generate radial expansion and compression of the frame. For example, the rod 52 of each actuator can be axially fixed relative to the sleeve 54 and slidable relative to the sleeve 54. Thus, in this manner, moving the rod 52 distally relative to the sleeve 54 and / or moving the sleeve 54 proximally relative to the rod 52 radially compresses the frame. Conversely, moving the rod 52 proximally relative to the sleeve 54 and / or moving the sleeve 54 distally relative to the rod 52 radially expands the frame.

[0041] When using a reciprocating actuator, the prosthetic valve may also include one or more locking mechanisms to hold the frame in the expanded state. The locking mechanisms may be separate components attached to the frame separate from the actuator or may be subcomponents of the actuator itself.

[0042] Each rod 52 can include an attachment member 58 along a proximal end of the rod 52 that is configured to form a releasable connection with a corresponding actuator of a delivery device. The actuator of the delivery device can apply a force to the rod to radially compress or expand the prosthetic valve 10. The attachment member 58 in the illustrated configuration includes a notch 60 and a protrusion 62 that can engage a corresponding protrusion of the actuator of the delivery device.

[0043] In the illustrated embodiment, the prosthetic valve 10 includes three such actuators 50, although in other embodiments, a greater or lesser number of actuators may be used. The leaflets 20 may have commissure attachment members 64 that encase the sleeves 54 of the actuators 50. Further details of the actuators, locking mechanisms for actuating the actuators, and delivery devices may be found in U.S. Pat. No. 10,603,165 and U.S. Patent Application Publication Nos. 2019 / 0060057, 2018 / 0153689, and 2018 / 0325665, each of which is incorporated herein by reference in its entirety. Any of the actuators and locking mechanisms disclosed in the previously filed applications may be incorporated into any of the prosthetic valves disclosed herein. Additionally, any of the delivery devices disclosed in the previously filed applications may be used to deliver and implant any of the prosthetic valves disclosed herein.

[0044] The prosthetic valve 10 may include one or more skirts or sealing members. In some embodiments, the prosthetic valve 10 may include an inner skirt (not shown) attached to the inner surface of the frame. The inner skirt may function as a sealing member to prevent or reduce perivalvular leakage, secure the leaflets to the frame, and / or protect the leaflets against damage caused by contact with the frame during crimping and working cycles of the prosthetic valve. As shown in FIG. 1, the prosthetic valve 10 may also include an outer skirt 70 attached to the outer surface of the frame 12. The outer skirt 70 may function as a sealing member for the prosthetic valve by sealing against the tissue of the native annulus and helping to reduce perivalvular leakage past the prosthetic valve. The inner and outer skirts may be formed from any of a variety of suitable biocompatible materials, including any of a variety of synthetic materials, including fabrics (e.g., polyethylene terephthalate fabric) or natural tissues (e.g., pericardial tissue). Further details regarding the use of skirts or sealing members in prosthetic valves can be found, for example, in US patent application Ser. No. 16 / 941,776, which is incorporated herein by reference in its entirety.

[0045] 3-4 show another embodiment of the prosthetic valve 100 including a frame 104 and an expansion and locking mechanism 200 (also referred to as an "actuator"). It should be understood that the prosthetic valve 100 may include other soft components, such as leaflets 20 and one or more skirts 70, which have been removed for illustrative purposes. The expansion and locking mechanism 200 may be used to radially expand and lock the prosthetic valve in a radially expanded state. In the example of FIGS. 3 and 4, three expansion and locking mechanisms 200 are attached to the frame 104, but any number of expansion and locking mechanisms 200 may be used in other exemplary delivery assemblies. FIG. 3 shows the expansion and locking mechanism 200 attached to the frame 104 when the frame is in a radially collapsed configuration, and FIG. 4 shows the expansion and locking mechanism attached to the frame when the frame is in a radially expanded configuration.

[0046] It will be appreciated that the prosthetic valve 100 may, in some embodiments, employ other mechanisms for expanding and locking, such as linear actuators, alternative locking mechanisms, and alternative expansion and locking mechanisms. Further details regarding the use of linear actuators, locking mechanisms, and expansion and locking mechanisms in prosthetic valves may be found, for example, in U.S. Patent No. 10,603,165, which is incorporated herein by reference in its entirety.

[0047] 5A-5C, the expansion and locking mechanism 200 in the illustrated embodiment can include an actuator screw 202 (which functions as a linear actuator or push-pull member in the illustrated embodiment) that includes a relatively long upper, or distal, portion 204 and a relatively short lower, or proximal, portion 206 at the proximal end of the screw 202, the lower portion having a smaller diameter than the upper portion. Both the upper and lower portions 204, 206 of the screw 202 can have externally threaded surfaces.

[0048] The actuator screw 202 can have a distal attachment piece 208 attached to its distal end having a radially extending distal valve connector 210. The distal attachment piece 208 can be fixed to the screw 202 (e.g., welded together or manufactured as one piece). The distal valve connector 210 can extend through an opening at or near the distal end of the frame 104 formed at a location on the frame where two or more struts intersect as shown in FIG. 5C. The distal valve connector 210 can be fixed to the frame 104 (e.g., welded). Due to the shape of the struts, the distal end of the frame 104 includes an alternating series of distal joints 150 and distal apexes 152. In the illustrated example, the distal valve connectors 210 of the three expansion and locking mechanisms 200 are connected to the frame 104 through the distal joints 150. In other examples, one or more distal valve connectors 210 can be connected to the frame 104 through the distal apexes 152. In other embodiments, the distal valve connector 210 may connect to a joint closer to the proximal end of the frame 104 .

[0049] The expansion and locking mechanism 200 may further include a sleeve 212. The sleeve 212 may be annularly disposed around the distal portion 204 of the screw 202 and may include axial openings at its proximal and distal ends through which the screw 202 may extend. The axial openings and lumens in the sleeve 212 may have a diameter larger than the diameter of the distal portion 204 of the screw 202 such that the screw may move freely within the sleeve (the screw 202 may move proximally and distally relative to the sleeve 212). Because the actuator screw 202 may move freely within the sleeve, it may be used to radially expand and / or contract the frame 104 as disclosed in further detail below.

[0050] The sleeve 212 can have a proximal valve connector 214 extending radially from its outer surface. The proximal valve connector 214 can be fixed (e.g., welded) to the sleeve 212. The proximal valve connector 214 can be axially spaced from the distal valve connector 210 such that the proximal valve connector can extend through an opening at or near the proximal end of the frame 104. The proximal end of the frame 104 includes an alternating series of proximal joints 160 and proximal apexes 162. In the illustrated example, the proximal valve connectors 214 of the three expansion and locking mechanisms 200 are connected to the frame 104 through the proximal joints 160. In other examples, one or more proximal valve connectors 214 can be connected to the frame 104 through the proximal apexes 162. In other embodiments, the proximal valve connectors 214 can be connected to a joint closer to the distal end of the frame 104.

[0051] It should be understood that the distal and proximal connectors 210, 214 do not have to be connected to opposite ends of the frame, as long as the distal and proximal connectors are connected to respective joints on the frame that are axially spaced apart from one another, the actuator 200 can be used to expand and compress the frame.

[0052] A locking nut 216 may be disposed inside the sleeve 212 and may have an internally threaded surface capable of engaging the externally threaded surface of the actuator screw 202. The locking nut 216 may have a notched portion 218 at its proximal end, the purpose of which is explained below. As discussed below, the locking nut may be used to lock the frame 104 into a particular radially expanded state.

[0053] 6 and 7 show an expansion and locking mechanism 200 that includes components of the delivery device not shown in FIGS. 5A-5C. As shown, the expansion and locking mechanism 200 can be releasably coupled to a support tube 220, an actuator member 222, and a locking tool 224. The proximal end of the support tube 220 can be connected to a handle or other control device (not shown) that a physician or operator of the delivery assembly utilizes to operate the expansion and locking mechanism 200 as described herein. Similarly, the proximal ends of the actuator member 222 and the locking tool 224 can also be connected to a handle.

[0054] Support tube 220 annularly surrounds a proximal portion of locking tool 224 such that the locking tool extends through the lumen of the support tube. Support tube 220 and sleeve are sized such that the distal end of the support tube abuts or engages the proximal end of sleeve 212 to prevent the support tube from moving distally beyond the sleeve.

[0055] The actuator member 222 extends through a lumen of the locking tool 224. The actuator member 222 can be, for example, a shaft, a rod, a cable, or a wire. A distal end of the actuator member 222 can be releasably connected to the proximal end 206 of the actuator screw 202. For example, the distal end of the actuator member 222 can have an internally threaded surface that can engage the external threads of the proximal end 206 of the actuator screw 202. Alternatively, the actuator member 222 can have external threads that engage the internally threaded portion of the screw 202. When the actuator member 222 is threaded onto the actuator screw 202, axial movement of the actuator member causes axial movement of the screw.

[0056] A distal portion of the locking tool 224 annularly surrounds the actuator screw 202 and extends through the lumen of the sleeve 212, and a proximal portion of the locking tool annularly surrounds the actuator member 222 and extends through the lumen of the support tube 220 to the handle of the delivery device. The locking tool 224 can have an internally threaded surface capable of engaging the externally threaded surface of the locking screw 202, such that clockwise or counterclockwise rotation of the locking tool 224 advances the locking tool distally or proximally along the thread, respectively.

[0057] 6, the distal end of the locking tool 224 can include a notched portion 226. The notched portion 226 of the locking tool 224 can have an engagement surface 227 configured to engage a correspondingly shaped engagement surface 219 of the notched portion 218 of the locking nut 216 such that rotation of the locking tool (e.g., clockwise) rotates the nut 216 in the same direction (e.g., clockwise) and advances it distally along the locking screw 202. The notched portions 218, 226 in the illustrated embodiment are configured such that rotation of the locking tool 224 in the opposite direction (e.g., counterclockwise) allows the notched portion 226 of the tool 224 to disengage from the notched portion 218 of the locking nut 216, i.e., rotation of the locking tool in a direction that moves the locking tool proximally does not cause a corresponding rotation of the nut.

[0058] In alternative embodiments, the distal end of the locking tool 224 can have a variety of other configurations adapted to engage the nut 216 and generate a rotation of the nut upon rotation of the locking tool to move the nut distally, such as any of the tool configurations described herein. In some embodiments, the distal end of the locking tool 224 can be adapted to generate a rotation of the nut 216 in both directions to move the nut distally and proximally along the locking screw 202.

[0059] In operation, prior to implantation, the actuator member 222 is threaded onto the proximal end 206 of the actuator screw 202 and the lock nut 216 is rotated so that it is disposed on the proximal end of the screw. The frame 104 can then be placed in a radially collapsed state and the delivery assembly can be inserted into the patient. Once the prosthetic valve is at the desired implantation site, the frame 104 can be radially expanded as described herein.

[0060] To radially expand the frame 104, the support tube 220 is held rigidly against the sleeve 212. The actuator member 222 is then pulled proximally through the support tube, for example by pulling on the proximal end of the actuator member or by actuating a control knob on the handle that generates proximal movement of the actuator member. Because the support tube 220 is held against the sleeve 212, which is connected to the proximal end of the frame 104 by the proximal valve connector 214, the proximal end of the frame is prevented from moving relative to the support tube. Thus, proximal movement of the actuator member 222 causes proximal movement of the actuator screw 202 (because the actuator member is threaded onto the screw), which shortens the frame 104 axially and expands radially. Alternatively, the frame 104 can be expanded by moving the support tube 220 distally while holding the actuator member 222 stationary, or by moving the support tube distally while moving the actuator member 222 proximally.

[0061] After the frame 104 has been expanded to a desired radial expansion size, the frame may be locked at this radial expansion size as described herein. Locking the frame may be accomplished by rotating the locking tool 224 in a clockwise direction to engage a notched portion 226 of the locking tool with a notched portion 218 of the locking nut 216, thereby advancing the locking nut distally along the actuator screw 202. The locking tool 224 may be rotated in this manner until the locking nut 216 abuts an internal shoulder at the distal end of the sleeve 212 such that the locking nut 216 cannot be advanced further distally (see FIG. 6 ). This will prevent the screw 202 from advancing distally relative to the sleeve 212 and radially compressing the frame 104. However, in the illustrated embodiment, the nut 216 and screw 202 may still be moved proximally through the sleeve 212, thereby allowing for additional expansion of the frame 104, either during implantation or during a subsequent valve-in-valve procedure.

[0062] Once the frame 104 is locked in the radially expanded state, the locking tool 224 can be rotated in a direction that moves the locking tool proximally (e.g., counterclockwise) to disengage the notched portion 226 from the notched portion 218 of the locking nut 216 and loosen the locking tool from the actuator screw 202. Additionally, the actuator member 222 can be rotated in a direction that loosens the actuator member from the lower portion 206 of the actuator screw 202 (e.g., the actuator member 222 can be configured to disengage from the actuator screw when rotated counterclockwise). Once loosened from the actuator screw 202, the locking tool 224 and actuator member 222 can be removed from the patient along with the support tube 220 with the actuator screw and sleeve 212 still connected to the frame 104 and the frame 104 locked in a particular radially expanded state, as shown in FIG.

[0063] In an alternative embodiment, the locking tool 224 can be formed without internal threads that engage the external threads of the actuator screw 202, thereby allowing the locking tool 224 to slide distally and proximally along the actuator screw 202 through the sleeve 212 to engage and release the nut 216.

[0064] In some embodiments, additional designs for the expansion and locking mechanisms can be used in place of the aforementioned designs. Details regarding the expansion and locking mechanisms can be found, for example, in U.S. Patent No. 10,603,165, which is incorporated herein by reference in its entirety.

[0065] FIG. 8 illustrates another embodiment of a prosthetic valve 300 including a frame 302 shown in its deployed, radially expanded configuration. The prosthetic valve 300 may include a valve structure (e.g., valve structure 18), an inner and / or outer skirt, and an actuator (e.g., actuator 50) as previously described, although these components have been omitted for purposes of illustration. The frame 302 may have an inflow end 304 and an outflow end 306. The prosthetic valve 300 may define a longitudinal axis A extending from the inflow end 304 to the outflow end 306, and a transverse axis B extending perpendicular to the longitudinal axis A. Although only one side of the frame 302 is depicted in FIG. 8, it should be understood that the frame 302 forms an annular structure with an opposite side that is identical to the portion shown.

[0066] The frame 302 includes a plurality of interconnected struts 308 arranged in a grid-type pattern. Each strut 308 may extend completely from the inflow end 304 to the outflow end 306 of the frame 302. Thus, in the illustrated embodiment, the frame 302 may be formed entirely of struts that extend continuously from the inflow end 304 to the outflow end 306. In alternative embodiments, the frame 302 may have struts connected end to end along the length of the frame. As discussed in more detail below, each strut may include one or more curved portions.

[0067] The struts 308 may include a set of radially inner struts (extending from the upper left to the lower right of the frame in FIG. 8) and a set of radially outer struts (extending from the lower left to the upper right of the frame in FIG. 8). The open lattice structure of the frame 302 may define a number of frame cells 310 between the struts 308.

[0068] 8, each strut 308 may be helically curved relative to the frame's longitudinal axis A to define the annular shape of the frame 302. The helical curve provides each strut with a concave, radially inner surface (the surface facing the longitudinal axis A) and an opposing convex, radially outer surface (the surface facing away from the longitudinal axis A).

[0069] Figure 9 shows a flattened projection of a single strut 308 in a plane P parallel to the longitudinal axis A of the frame 302. Plane P is an XY plane (see, e.g., coordinate system 316) with axes C and D extending parallel to the Z axis and perpendicular to the longitudinal axis A and plane P. Figure 9 shows an exaggerated curvature of the strut 308 for purposes of illustration; however, in other embodiments, the curvature of the strut 308 may be less pronounced than that shown.

[0070] As shown in FIG. 9, each of the struts 308 can include a plurality of apertures 312. The apertures 312 can be spaced along the length of the strut 308. For example, the apertures 312 can be spaced unequally along the length of the strut 308 to define a plurality of segments 314. In the illustrated embodiment, the strut 308 includes segments 314a, 314b, 314c, 314d, 314e, 314f. Segments 314a and 314b have a first length, segments 314c and 314d have a second length greater than the first length, and segments 314e, 314f have a third length greater than the first and second lengths. In other embodiments, the apertures 312 can be evenly spaced along the length of the strut 308 to define a plurality of equal segments 314.

[0071] In the illustrated embodiment, each segment 314 has an equal width W. However, in other embodiments, the width of each segment 314 may vary along the length of the strut 308. For example, the width of segment 314a adjacent the inflow end 304 of the frame 302 may be greater than the width of segment 314f adjacent the outflow end 306 of the frame, or vice versa.

[0072] As shown, the segments 314 may be disposed end-to-end relative to one another with adjacent ends interconnected to one another by intermediate segments 318. The struts 308 may have enlarged (relative to the segments 314) ends 320 that form apexes 322 at the inflow and outflow ends 304, 306 of the frame 302. Each of the intermediate segments 318 and ends 320 may have a respective opening 312, e.g., at its geometric center, for receiving a fastener. As shown, each segment 314 may be slightly laterally offset from an adjacent segment 314 in a direction perpendicular to the length of the strut 308. In an alternative embodiment, the segments 314 may be disposed without any offset relative to one another.

[0073] The strut 308 may include a first portion, or lower portion, 324, and a second portion, or upper portion, 326. The first portion 324 may be disposed adjacent the inflow end 304, and the second portion 326 may be disposed adjacent the outflow end 306. The portions 324, 326 may be separated by a deflection point 328. In the illustrated embodiment, the first portion 324 is curved relative to a line C that is parallel to the horizontal axis B and disposed between the first portion 324 and the inflow end of the frame 302. This configuration may be considered convex relative to the outflow end 306 of the frame, and the first portion 324 may also be referred to as a "convex portion." The second portion 326 is curved relative to a line D that is parallel to the horizontal axis B and disposed between the second portion 326 and the outflow end 306 of the frame 302. This configuration may be considered concave relative to the outflow end 306 of the frame, and the second portion 326 may also be referred to as a "convex portion."

[0074] In other words, the first portion 324 can be thought of as a straight rod bent about a line C (which extends into and out of the plane P) to form a convex curve, and the second portion 326 can be thought of as a straight rod bent about a line D (which extends into and out of the plane P) to form a concave curve. This configuration is such that the overall shape of the strut 308 is sinusoidal. As used herein, when a component such as a strut or strut segment is curved about a particular axis, it means that the component is curved about that axis, which is perpendicular to the plane P and parallel to a line extending through the center of curvature of the curve. The curved portions 324, 326 of the struts 308 can provide the frame with additional resistance to buckling or other deformation during expansion or use of the prosthetic valve 300.

[0075] In the illustrated embodiment, the deflection point 328 is located at a midpoint along the length of the strut such that the first portion 324 and the second portion 326 have equal lengths. In other embodiments, the deflection point 328 can be located anywhere along the length of the strut 308 such that the first and second portions 324, 326 have unequal lengths. In some particular embodiments, locating the deflection point 328 such that the protrusion 324 is shorter than the recess 326 can improve the resistance of the frame 302 to buckling at the inflow end 304, for example, during expansion of the frame.

[0076] In other embodiments, each strut 308 can have more than one deflection point and define more than two strut portions. For example, a strut can have a first portion configured as a recess, a second portion configured as a protrusion, and a third portion configured as a recess. In other embodiments, a strut can have any number of portions, and portions configured as recesses or protrusions and arranged in any order.

[0077] In certain embodiments, each section 324, 326 can have a continuous and constant curvature from one end of the section to the deflection point 328. For example, each segment 314 of the sections 324, 326 can have a curved shape that contributes to the overall curved shape. In other embodiments, each segment 314 can be straight (excluding any helical curvature about the longitudinal axis A) and the amount of offset of each segment 314 relative to adjacent segments 314 along the length of the section 324, 326 can vary such that the overall shape of each section 324, 326 is curved along its length relative to the transverse axis B. Alternatively, the individual strut segments 314 can be straight and connected end to end to each other at a non-zero angle such that each section 324, 326 is curved along its length.

[0078] 10 shows an outline of frame 302 superimposed on frame 302', which is frame 302 in an deployed or unfolded configuration in plane P defined by the X and Y axes of the illustrated coordinate system 316. For any strut 308 of frame 302, a diagonal line or axis E can be drawn extending through both ends of the strut 308 and through the inflow and outflow ends 304, 306 of the frame 302, with axis E forming an arbitrary angle with axis A. From left to right, a first portion 324 of each strut 308 curves from axis E toward the outflow end and then back toward axis E at a deflection point 328, and a second portion 326 curves from axis E toward the inflow end 304 and then back toward axis E at the end of the strut 308.

[0079] The degree of curvature of each strut segment 324, 326 in plane P can be defined as the inverse of the radius of a circle that contains that segment of the strut as an arc, as shown in the following equation:

[0080]

number

[0081] Here, K s = the curvature of the strut section, and R = the radius of the circle that includes the sections 324, 326 of the strut 308 as arcs of the circle.

[0082] In the illustrated embodiment, the first and second portions 324, 326 each have approximately the same degree of curvature. However, in other embodiments, each portion 324, 326 can have a different degree of curvature in the plane P. In still other embodiments, one or more of the portions can be straight in the plane P. For example, a strut can have a first portion configured as a straight portion and a second portion configured as a convex or concave portion. In some embodiments, due to the elasticity of the struts and the connections between overlapping struts, the degree of curvature of the portions of the strut can change during radial expansion and compression of the frame. In the radially compressed configuration, each portion 324, 326 can be deformed to have a lesser degree of curvature (e.g., each portion can be more straight or rectilinear in the plane P) than in the radially expanded configuration.

[0083] Depending on the location of the deflection points 328 on each strut 308, in the expanded configuration, the assembled frame 302 can have any of a variety of shapes. For example, in some embodiments, such as the illustrated embodiment, the location of the deflection points 328 can give the frame 302 a non-cylindrical, tapered shape where the outflow end 306 has a first diameter D1 that is greater than the second diameter D2 of the inflow end 304. In other embodiments, the location of the deflection points can give the frame 302 a tapered shape where the second diameter D2 is greater than the first diameter D1. In still other embodiments, the deflection points 328 can be positioned to give the frame a cylindrical, frusto-conical, V-shaped, and / or Y-shaped shape.

[0084] As shown in FIG. 8, in the assembled frame 302, the struts 308 form a plurality of cells 310 arranged in a plurality of circumferentially extending rows of cells having various sizes. In the illustrated embodiment, each strut 308 has six segments 314 and seven openings 312 (FIG. 9) that define five rows of cells, including a first row of cells 310a, a second row of cells 310b, a third row of cells 310c, a fourth row of cells 310d, and a fifth row of cells 310e. In the illustrated embodiment, the rows of cells 310 can have various sizes. For example, in some embodiments, the cells in row 310a are the smallest, and the subsequent cells 310b, 310c, 310d, and 310e are progressively larger. In other embodiments, cells 310a and 310e can be smaller than cells 310b, 310c, and 310d. 11, cell 310a can be smaller than cell 310b, which can be smaller than central cell 310c, and cell 310e can be smaller than cell 310d, which can be smaller than central cell 310c. In other embodiments, each strut 308 can have a greater or lesser number of openings 312 to define a different number of strut segments and rows of frame cells.

[0085] Smaller cells, such as cell 310a in the illustrated embodiment, can reduce bending or deformation of the frame 302. For example, in some cases, proximal forces applied to the inflow end 304 of the frame 302 during expansion of the prosthetic valve 300 with an actuator (e.g., actuator 50) can cause the frame 302 to deform and / or buckle. Smaller cells have greater structural strength and can therefore prevent or reduce such deformation. Additionally, the frame 302 can be positioned within the native annulus such that the smaller cell 310a can withstand a greater amount of radial force applied by the native annulus than larger cells, such as cells 310c and 310d.

[0086] The larger cells, such as cells 310c and 310d in the illustrated embodiment, can be sized to allow access to the coronary vessels when the prosthetic valve 300 is implanted within the patient's native annulus. For example, in some cases, a patient may be required to implant a coronary stent (or other procedure requiring access to the coronary vessels) after a prosthetic heart valve, such as the prosthetic valve 300, has been implanted. In such cases, a physician may access the coronary vessels through the outflow end 306 of the prosthetic valve by passing through the larger cells 310c, 310d of the frame 302. This allows a physician to access the coronary vessels without having to remove or move the prosthetic heart valve.

[0087] FIG. 11 illustrates an alternative embodiment of a prosthetic heart valve 400. The prosthetic valve 400 is similar to the prosthetic valve 300, except that the prosthetic valve 400 has a frame 402 in which each strut 408 has a first portion 410 configured as a recess and a second portion 412 configured as a protrusion. The prosthetic valve 400 may include a valve structure (e.g., valve structure 18), an inner and / or outer skirt, and an actuator (e.g., actuator 50) as previously described, although these components have been omitted for purposes of illustration. The frame 402 has an inflow end 404 and an outflow end 406. Although only one side of the frame 402 is depicted in FIG. 11, it should be understood that the frame 402 forms an annular structure with an opposite side that is identical to the portions shown.

[0088] A first portion, or lower portion 410, of each strut 408 may be positioned adjacent the inflow end 404 of the prosthetic valve 400, and a second portion, or upper portion 412, of each strut 408 may be positioned adjacent the outflow end 406. The two portions 410, 412 may be separated by a deflection point 414.

[0089] As shown in an exaggerated manner by line 408', the first portion 410 may be concave with respect to the outflow end 406 of the frame 402. In other words, the first portion 410 may be considered as a straight rod disposed between the first portion 410 and the outflow end 406 and bent about a line extending into and out of the plane P to form a concave curve. The second portion 412 may be convex with respect to the outflow end 406. In other words, the second portion 412 may be considered as a straight rod disposed between the second portion 412 and the inflow end 404 and bent about a line extending into and out of the plane P to form a convex curve. The alternating concave and convex portions give the strut 408 an overall sinusoidal shape.

[0090] 11, each strut 408 may be helically curved relative to the longitudinal axis A of the frame to define the annular shape of the frame 402. The helical curve provides each strut with a concave, radially inner surface (facing the longitudinal axis A) and an opposing convex, radially outer surface (opposite the longitudinal axis A). As previously described with respect to the frame 302, the deflection point 414 of each strut may be located anywhere along the length of the strut 408. For example, in the illustrated embodiment, the deflection point 414 is located at a midpoint along the length of the strut 408 such that the first and second portions 410, 412 have equal lengths.

[0091] The degree of curvature of each portion 410, 412 of the strut 408 in the plane P can be determined using Equation 1 described above with reference to the prosthetic valve 300. In the illustrated embodiment, the first and second portions 410, 412 have approximately the same degree of curvature. However, in other embodiments, each portion can have a different degree of curvature in the plane P.

[0092] Depending on the location of the deflection points 414 on each strut 408, in the expanded configuration, the assembled frame 402 can have any of a variety of shapes. As shown in the illustrated embodiment, the location of the deflection points 414 can give the frame 402 a non-cylindrical, tapered shape in which the outflow end 406 has a larger diameter than the inflow end 404. In other embodiments, the location of the deflection points can give the frame a cylindrical, frusto-conical, V-shaped, and / or Y-shaped shape.

[0093] Similar to frame 302, frame 402 may have a plurality of cells 416 arranged in a plurality of circumferentially extending rows of various sizes. As shown in FIG. 11, frame 402 may have five rows of cells, including a first row of cells 416a, a second row of cells 416b, a third row of cells 416c, a fourth row of cells 416d, and a fifth row of cells 416e. In the illustrated embodiment, row 416a is smaller than row 416b, which is smaller than center row 416c, and row 416e is smaller than row 416d, which is smaller than center row 416c.

[0094] As mentioned above, smaller cells, such as cells 416a and 416e in the illustrated embodiment, can reduce bending or deformation of the frame, while larger cells, such as cell 416c, can allow access to the coronary vessels when the prosthetic valve 400 is implanted within the patient's native annulus.

[0095] When compressed into a radially compressed configuration, in certain embodiments, the struts of the frame 302 or 402 can elastically deform along their length due to the pin connections between the overlapping struts, similar to the bending of a beam supported at both ends. When the frame is held in a radially compressed state (e.g., within a sheath of a delivery device), the elastically deformed struts place the frame in tension. Thus, when released from the radially compressed state (e.g., when deployed from the sheath of a delivery device), the struts provide a spring force that at least partially expands the frame. If necessary, the frame can be further expanded to a fully expanded state using an actuator (e.g., actuator 50). As noted above, the struts of the frame can be formed from a variety of metals, including plastically deformable metals, such as stainless steel or cobalt chromium alloys, or superelastic materials, such as nickel titanium alloys ("NiTi"), e.g., Nitinol. When formed from a plastically deformable metal, when the frame is compressed from a radially expanded state to a radially compressed state (and vice versa), the struts and the connections between the struts can be configured to maintain the struts within a range of elastic deformation for the metal to prevent plastic deformation of the frame when transitioning between the radially compressed and radially expanded states.

[0096] In some embodiments, the spring force of the struts can be sufficient to generate a full radial expansion of the frame from a compressed state to an expanded and operating state in which the leaflets (e.g., leaflets 20) can function to regulate blood flow through the prosthetic valve. In this manner, the frame can fully self-expand from the compressed state to the expanded state without the use of an actuator (e.g., actuator 50). The prosthetic valve can include one or more locking mechanisms configured to hold the frame in the expanded state.

[0097] When implanted, the frames of the prosthetic valves 300 and 400 are configured to prevent or mitigate buckling or other deformation at the inflow end during expansion or use of the prosthetic valve. As previously mentioned, the larger cells (e.g., cells 310c, 416c) in the outflow or central portion of the frame can allow a physician to access the coronary vessels through the outflow end of the valve by passing through the larger cells of the frame. This configuration can advantageously allow a physician to access the coronary vessels without having to remove or move a previously implanted prosthetic heart valve.

[0098] As mentioned above, each strut of the frame may include one or more apertures (e.g., aperture 312 mentioned above) disposed along the length of the strut. Respective hinges or joints may be formed where the struts overlap one another. At one or more locations, the struts may be held together at each joint via fasteners such as rivets or pins extending through the apertures. The fasteners may extend through one or more apertures in the first and / or second struts to secure the struts together while allowing the struts to pivot relative to one another about the fasteners as the frame is radially expanded or compressed. In such embodiments, one or more radially outer ends of the fasteners may be deformed to hold the fasteners within the apertures. Further details of such fasteners may be found, for example, in U.S. Patent Application Publication No. 2018 / 0344456 and International Application No. PCT / US2020 / 057691, both of which are incorporated herein by reference in their entireties.

[0099] However, in some embodiments, each joint need not secure the struts to one another and allow pivotable movement of the struts relative to one another. For example, FIG. 12 shows a prosthetic valve 500 having a frame 502 including a plurality of first struts 504 (e.g., radially outer struts), each of which may be coupled to one or more of a plurality of second struts 506 (e.g., radially inner struts) at a plurality of joints 508. Some joints (e.g., one or more joints adjacent the inflow end 510 and one or more joints adjacent the outflow end 512 of the prosthetic valve 500) are configured as fixed joints 514. One or more other joints (e.g., the central joints of selected struts) may be configured as pivotable joints 516 that allow the struts 504, 506 to pivot relative to one another without securing the struts 504, 506 to one another.

[0100] For example, in the illustrated embodiment, each first strut 504 can be coupled to one or more second struts 506 via seven joints 508a-g. The joints adjacent the inflow end 510, joints 508a and 508b, and the joints adjacent the outflow end 512, joints 508f and 508g, can be configured as fixed joints 514. The central joints 508c-e can be configured as pivotable joints 516.

[0101] The prosthetic valve 500 may further include a valve structure 518 disposed within the frame 502, one or more expansion and locking mechanisms 520 configured to move the prosthetic valve between a radially expanded position and a radially compressed position, and one or more skirts or sealing members (e.g., an inner skirt 522). In some embodiments, the prosthetic valve 500 may further include an outer skirt disposed on a radially outer surface of the frame.

[0102] 13 illustrates a portion of an exemplary second strut 506 (e.g., a radially inner strut) including a fastener 524 extending from a radially outer surface 526 of the strut 506. In the illustrated embodiment, the fastener 524 is integrally formed with the strut 506, however, in other embodiments, the fastener 524 may be formed separately from the strut 506 and may be coupled to the strut (e.g., by welding or other mechanical fastening means) or may be a separate component extending through the strut 506. In the illustrated embodiment, the fastener 524 is configured as a cylindrical protrusion having a body 528 that includes an internal bore 530 extending therethrough. However, in other embodiments, the fastener 524 may have any of a variety of shapes.

[0103] FIG. 14 illustrates an exemplary fixed joint 514 between a second strut 506 and a first strut 504 (e.g., a radially outer strut). A fastener 524 can extend through a corresponding aperture 532 in the first strut 504 and can function as a pivot pin about which the two struts 504, 506 can pivot relative to one another. In some embodiments, an end 534 ( FIG. 13 ) (e.g., a radially outer end) of the fastener 524 can be deformed (e.g., by applying an axial compressive force, such as by using a punch) to form a flanged end 536 having a larger diameter than the aperture 532 such that the fastener 524 is retained within the aperture 532 that joins the first and second struts 504, 506 to one another. An inner bore 530 of the fastener 524 can be configured, for example, to promote uniform deformation of the end 534.

[0104] 15 illustrates an exemplary pivotable joint 516 between a first strut 504 (e.g., a radially outer strut) and a second strut 506 (e.g., a radially inner strut), showing the first strut 504 in cross section along the longitudinal axis of the strut 504. The second strut 506 may include a protrusion 538 extending from a radially outer surface 526 of the strut 506. The first strut 504 may include a corresponding recess or socket 540 into which the protrusion 538 may extend. The corresponding shapes of the protrusion 538 and the socket 540 allow the first and second struts 504, 506 to pivot relative to one another about the joint 516.

[0105] In the illustrated embodiment, the projection 538 can have a domed, hemispherical shape and the socket 540 can be correspondingly hemispherical. Thus, the projection 538 and the socket 540 form a ball-and-socket type pivot joint. In other embodiments, the projection 538 can include a variety of shapes and the socket 540 can have a corresponding shape configured to receive the projection 538 and allow rotation of the projection 538 within the socket 540. As shown in FIG. 15 , the socket 540 can have a depth that is less than the thickness of the post 504 such that a radially outer surface 542 of the first post 504 at each pivotable joint 516 is flat.

[0106] 12, in the illustrated embodiment, each strut 504, 506 may include a number of straight segments 544 coupled to one or more adjacent straight segments via one or more intermediate segments 546. The intermediate segments 546 of each strut 504, 506 may be aligned with the joints 508 to which the struts 504, 506 are coupled.

[0107] In some embodiments, each second strut 506 can include four fasteners 524 (FIG. 13) and three protrusions 538 spaced along the length of the strut 506. The fasteners 524 can be positioned to align with joints 508a, 508b, 508f, and 508g, and the protrusions 538 can be positioned along the strut to align with joints 508c, 508d, and 508e when the frame 502 is assembled. In such embodiments, each radially outer strut 504 can include four apertures 532 that align with the respective fasteners 524 at joints 508a, 508b, 508f, and 508g, and three sockets 540 that align with the protrusions 538 at joints 508c, 508d, and 508e. Such a configuration allows the struts 504, 506 to be fixed to one another at the fixed joints 514 and pivotable relative to one another at the pivotable joints 516 without risking the fasteners protruding from the pivotable joints 516 during crimping of the prosthetic valve, reducing the overall crimped profile of the prosthetic valve and / or reducing the risk of abrasion to the native anatomical structures at the selected implantation site of the prosthetic valve.

[0108] Without pivotable joints such as those embodied herein, fasteners extending through openings along central joints 508c, 508d, 508e of frame 502 could protrude radially from the outer surface of the frame during crimping of the valve in an undesirable manner.

[0109] 16, in some embodiments, the prosthetic valve can include first and second struts 600, 602, which can be coupled together at an exemplary joint 604 using fasteners 606. In the embodiment shown in FIG. 16, the first strut 600 is the radially outer strut and the second strut 602 is the radially inner strut, although in other embodiments the first strut 600 can be the radially inner strut and the second strut 602 can be the radially outer strut.

[0110] As shown in FIG. 17, the fastener 606 can have a body portion 608 having a first diameter D1, a head portion 610 having a second diameter D2 larger than the first diameter D1, and an inner bore 612 extending through the body portion 608. In some embodiments, the inner bore 612 can also extend through the head portion 610. Because of the inner bore 612, the fastener 606 can be referred to as a "hollow" fastener in some cases. During assembly of the prosthetic valve, an end 614 of the fastener 606 can be deformed (e.g., by applying an axial compressive force, such as by using a punch or the like) to form a flanged end 616 ( FIG. 16 ) having a larger diameter than the body portion 608. The inner bore 612 of the fastener 606 can be configured to promote uniform deformation of the end 614.

[0111] 16 , the first strut 600 can include a first aperture 618 extending through a thickness of the first strut 600, and the second strut 602 can include a second aperture 620 extending through a thickness of the second strut 602. In some embodiments, one or more of the apertures 618, 620 can be surrounded by a respective recess 622, 624. The first recess 622 can be disposed, for example, on a radially outer surface 626 of the first strut 600 and extend toward an inner surface of the first strut 600. The second recess 624 can be disposed on a radially inner surface 628 of the second strut 602 and extend toward an outer surface of the second strut 602.

[0112] In the illustrated embodiment of FIG. 16, each recess 622, 624 is configured as a counterbore 630. Each counterbore 630 can have a cylindrical shape including a base 632 and a sidewall 634 arranged perpendicularly (or at least substantially perpendicularly) relative to one another. Each counterbore 630 can have a diameter D3 that is greater than a diameter D4 of the respective opening 618, 620 such that each counterbore 630 and each opening 618, 620 form a stepped or staircase-like configuration. As shown, the counterbore 630 disposed in the second post 602 can be configured to receive the head portion 610 of the fastener 606, and the counterbore 630 disposed in the first post 600 can be configured to receive the flanged end 616. Such a configuration advantageously prevents the flanged end 616 from protruding radially outwardly beyond the radially outer surface 626 of the first strut 600, thereby reducing the overall crimped profile of the prosthetic valve and reducing the risk of abrasion to the native anatomical structures at the selected implantation site of the prosthetic valve.

[0113] 18, in some embodiments, instead of a counterbore 630, the first recess 622 can be configured as a countersink 636. The countersink 636 can have a first diameter D5 at the radially outer surface 626 of the first strut 600 that tapers to a second diameter D6 where the countersink meets the opening 618. The second diameter D6 can be substantially equal to that of the opening 618. In other words, the countersink 636 can have a frusto-conical shape. The countersink 636 can be configured to receive the flanged end 616 of the fastener 606 such that the flanged end 616 does not protrude outwardly beyond the radially outer surface 626 of the first strut 600. Such a configuration advantageously prevents the flanged end 616 from reducing the overall crimped profile of the prosthetic valve, reducing the risk of abrasion to native anatomy at the selected implantation site of the prosthetic valve.

[0114] In other embodiments, both recesses 622, 624 can be configured as countersinks 636. In yet other embodiments, the second recess 624 can be configured as a countersink 636 and the first recess 622 can be configured as a counterbore 630, or vice versa.

[0115] 19-20, in another embodiment, a prosthetic heart valve can include first and second struts 700, 702 that are joined together at an exemplary joint 704 using fasteners 706 that extend through openings 708, 710 in the first and second struts 700, 702. In the embodiment shown in FIG. 19, the first strut 700 is the radially outer strut and the second strut 702 is the radially inner strut, although in other embodiments the first strut can be the radially inner strut and the second strut can be the radially outer strut.

[0116] The fastener 706 can have a body portion 712 having a first diameter D7 and a head portion 714 having a second diameter D8 that is larger than the first diameter D7. Due to the lack of an internal bore, the fastener 706 may be referred to as a "solid" pin or fastener. During assembly of the prosthetic valve, an end 716 of the fastener 706 can be deformed (e.g., using radial riveting) to form a flanged end 718 having a diameter D9 that is larger than the diameter of the openings 708, 710. Thus, the fastener 706 is held within the openings 708, 710 at its radially inner end by the head portion 714 and at its radially outer end by the flanged end 718, thereby coupling the first and second struts 700, 702 to one another and providing a pivot pin about which the struts 700, 702 can pivot relative to one another.

[0117] 20, in some embodiments, the fastener 706 can be deformed using radial riveting. Radial riveting can be performed using a riveting member 720. The riveting member 720 can rotate about the fastener 706 and apply pressure to the radially outer end surface 716 in a rosette-shaped path (e.g., a hypocycloidal path) to gently deform the fastener 706, thereby forming the flanged portion 718. The longitudinal axis of the riveting member 720 is disposed at an angle relative to the riveting surface (e.g., the radially outer end surface 716 of the fastener 706). The amount of force applied, the length of the riveting process, and the shape of the riveting member 720 can each be varied to change the diameter, thickness, and / or shape of the flanged portion 718.

[0118] Radial riveting has various advantages: it applies little lateral force, mitigating the need to crimp or lock the struts 700, 702 in place during the riveting process, and it applies little axial force, thereby reducing the risk of damaging or bending the struts 700, 702. Additionally, because radial riveting is a cold forming process, the flanged portion 718 can be formed without deforming or swelling the remainder of the fixture body 712. The radial riveting process can further create a smooth finish on the flanged end 718, mitigating potential damage if the fixture 706 comes into contact with the sheath of the delivery device during delivery of the prosthetic valve and / or with the native anatomy of the implantation site. This configuration can advantageously simplify assembly of the prosthetic valve, for example, by allowing much simpler processing and machining procedures to be used. This configuration further avoids impact punching, as is performed with hollow tube fixtures having internal bores. When a component is very small, it can be difficult to drill an internal bore and the internal bore can weaken the component, thus requiring a larger component (e.g., a pin). A solid fastener does not have an internal bore, and therefore the diameter of the solid fastener (e.g., fastener 706) can be smaller than that of a typical hollow fastener.

[0119] 19 , each post 700, 702 can include a respective recess 722, 724 surrounding the opening 708, 710. Each recess 722, 724 can be configured as a counterbore or countersink and can be configured to receive the head portion 714 or flanged end 718 of the fastener 706. The first recess 722 can be disposed, for example, in a radially outer surface 726 of the first post 700 and the second recess 722 can be disposed in a radially inner surface 728 of the second post 702. In the illustrated embodiment, both the first and second recesses 722, 724 are configured as countersinks, similar to the countersink 636 described above. In other embodiments, both recesses 722, 724 can be configured as counterbores (e.g., similar to counterbore 630 described above), and in yet other embodiments, the first recess 722 can be a counterbore and the second recess 724 can be a countersink, or vice versa.

[0120] 21-22, in some embodiments, instead of separately formed fasteners such as fasteners 606 and 706 described above, a prosthetic valve can include first and second struts 800, 802 that are joined together at a junction 804 via a fastener 806 integrally formed with the second strut 802. In the embodiment shown in FIG. 21, the first strut 800 is the radially outer strut and the second strut 802 is the radially inner strut, although in other embodiments the first strut can be the radially inner strut and the second strut can be the radially outer strut.

[0121] As shown in FIG. 22, the second strut 802 can include a plurality of straight segments 808 coupled together via a plurality of intermediate portions 810. Each intermediate portion 810 can include an integrally formed fastener 806 extending from a surface 814 (e.g., a radially outer surface) of the strut 802. As shown, the integrally formed fastener 806 can be a solid fastener lacking an internal bore. Due to the lack of an internal bore, the fastener 806 can have a relatively small diameter when compared to the diameter of a hollow fastener, such as the fastener 606. Thus, in such an embodiment, the intermediate portions 810 of the struts 800, 802 can be correspondingly narrower. Such a configuration advantageously allows a prosthetic valve including such struts 800, 802 to have a smaller diameter when in a compressed configuration.

[0122] During assembly of the prosthetic valve, as shown in FIGURE 21, each fastener 806 can be inserted through a corresponding aperture 816 in a respective first strut 800 (e.g., a radially outer strut). The aperture 816 can be surrounded by a recess 818 disposed in a radially outer surface 824 of the first strut 800. In the illustrated embodiment, the recess 818 is configured as a countersink (similar to countersink 636), although in other embodiments, the recess 818 can be configured as a counterbore (similar to counterbore 630). After the fastener 806 is inserted through the opening 816, an end 820 of the fastener 806 can be deformed (e.g., using radial riveting) to form a flanged end 822 having a diameter D10 larger than the diameter D11 of the opening 816 so that the fastener 806 is retained within the opening 816, thereby coupling the first and second support posts 800, 802 to one another and providing a pivot pin around which the support posts 800, 802 can pivot relative to one another.

[0123] 23-24, in some embodiments, a prosthetic valve can include first and second struts 900, 902 coupled together at an exemplary junction 904 via a fastener 906 that includes an internal slot 908. In the illustrated embodiment, the fastener 906 is integrally formed with the second strut 902. However, in other embodiments, the fastener 906 can be integrally formed with the first strut 900 or can be formed separately from both the first and second struts 900, 902 and coupled thereto by a head portion formed at the base of the fastener 906 (such as, for example, head portion 714 of fastener 706).

[0124] With reference to FIG. 24, the fastener 906 can include a body portion 910 having a first diameter D12 and a head portion or protrusion 912 configured as a flared or bulged portion having a second diameter D13 that is greater than the first diameter D12. As previously described, the fastener 906 can include an internal slot 908 that extends at least partially along the length of the fastener 906. In some embodiments, the slot 908 can extend through the thickness of the fastener 906 such that the slot divides the fastener 906 into two halves. In such embodiments, the two halves can be referred to as "ears" or "tabs." In other embodiments (and as depicted in FIGS. 23-24), the slot 908 can be completely enclosed within the fastener 906, thereby forming a hollow lumen extending through the fastener. In such cases, the internal slot can be referred to as a "window."

[0125] The fastener 906 can include a resilient material configured to allow the fastener 906 to be squeezed or compressed such that the slot 908 can be narrowed and then resiliently returned to its unnarrowed state, such that the fastener 906 can move between a compressed configuration and an uncompressed configuration. For example, the fastener 906 can include stainless steel, a cobalt chromium alloy, a nickel titanium alloy ("NiTi" or "nitinol"), and / or other resiliently deformable materials (including polymers).

[0126] 23, during assembly of the prosthetic valve, the fastener 906 can be inserted through an aperture 914 in the first strut 900 (e.g., the radially outer strut). The aperture 914 can have a diameter D14 narrower than the diameter D13 of the projection 912. Thus, the fastener 906 can be compressed as it is forced through the aperture 914 such that the projection 912 deforms axially inward (as represented by the dotted line 916) and narrows the inner slot 908. Upon emerging from the aperture 914, the projection 912 can resiliently return to its original shape having a diameter D13 larger than the aperture diameter D14, retaining the fastener 906 within the aperture 914, thereby coupling the first and second struts 900, 902 to one another and providing a pivot pin about which the struts 900, 902 can pivot relative to one another.

[0127] 23, the opening 922 can be surrounded by a recess 918. In the illustrated embodiment, the recess 918 is configured as a countersink (similar to countersink 636) having a tapered shape that extends from a first diameter at the opening to a second, larger diameter at the radially outer surface 920 of the first strut 900, although in other embodiments, the recess 918 can be configured as a counterbore (similar to counterbore 630). The recess 918 can be configured such that the protrusion 912 can be positioned within the recess 918 without extending beyond the radially outer surface 920 of the first strut 900.

[0128] Such an arrangement allows each second strut 902 to be preformed with a plurality of fasteners 906, each having a projection 912 formed thereon. This advantageously allows for assembly of the prosthetic valve frame from the struts 900, 902 by simply inserting the fasteners 906 through openings 914 in the first strut 900. No additional steps (e.g., flanging the fasteners via riveting or punching) or specific tools (e.g., punches or riveting members) are required to retain the fasteners 906 within the openings 914.

[0129] Additional Examples of the Disclosed Technology In view of the above-mentioned implementations of the disclosed subject matter, the present application discloses additional examples, which are listed below. It should be noted that one feature of one example alone, or more than one feature of that example in combination, and optionally in combination with one or more features of one or more additional examples, are also additional examples that fall within the disclosure of the present application.

[0130] Example 1. An implantable prosthesis including a frame that is radially expandable and compressible between a radially compressed configuration and a radially expanded configuration. The frame includes a plurality of struts, each strut including a first portion and a second portion separated by a deflection point. Each strut is helically curved relative to a first longitudinal axis of the frame. The first portion of each strut is curved in a first direction relative to a first line parallel to a second axis that is perpendicular to the first longitudinal axis of the frame. The second portion of each strut is curved in a second direction relative to a second line parallel to the second axis.

[0131] Example 2 The implantable prosthesis of any of the examples herein, particularly example 1, wherein the first portion of the strut is convex relative to the outflow end of the frame.

[0132] Example 3 The implantable prosthesis of any of the examples herein, particularly Example 1 or Example 2, wherein the second portion of the strut is concave relative to the outflow end of the frame.

[0133] Example 4. The implantable prosthesis of any one of the examples herein, particularly any one of Examples 1-3, wherein a first portion of the strut is positioned adjacent to the inflow end of the frame and a second portion is positioned adjacent to the outflow end of the frame.

[0134] Example 5. The implantable prosthesis of any one of the examples herein, particularly any one of Examples 1-3, wherein a first portion of the strut is positioned adjacent to the outflow end of the frame and a second portion is positioned adjacent to the inflow end of the frame.

[0135] Example 6 The implantable prosthesis of any one of the examples herein, particularly any one of Examples 1-5, wherein the first and second portions have equal lengths.

[0136] Example 7. The implantable prosthesis of any one of Examples herein, particularly any one of Examples 1-5, wherein the first portion has a first length and the second portion has a second length, the first length being greater than the second length.

[0137] Example 8. The implantable prosthesis of any one of Examples herein, particularly any one of Examples 1-5, wherein the first portion has a first length and the second portion has a second length, the second length being greater than the first length.

[0138] Example 9. The implantable prosthesis of any of the examples herein, particularly any one of Examples 1-8, wherein the plurality of struts includes a first set of a plurality of struts extending in a first direction and a second set of a plurality of struts extending in a second direction, each strut of the first set of struts connected to at least one strut of the second set of struts to form a plurality of cells.

[0139] Example 10. The implantable prosthesis of any of the examples herein, particularly Example 9, wherein the plurality of cells includes a first row of cells adjacent a first end of the frame and a second row of cells disposed between the first end and a second end of the frame, the first row of cells being smaller than the second row of cells.

[0140] Example 11 The implantable prosthesis of any example herein, particularly example 10, further comprising a third row of cells adjacent the second end of the frame, the third row of cells being smaller than the second row of cells.

[0141] Example 12. The implantable prosthesis of any of the Examples herein, particularly any one of Examples 1-11, wherein each strut extends from a first end of the frame to an axially opposite second end of the frame.

[0142] Example 13. The implantable prosthesis of any of the examples herein, particularly any one of Examples 1-12, wherein when the frame is in a radially expanded configuration, the frame tapers from a first diameter at a first location on the frame to a second diameter at a second location on the frame axially spaced from the first location, the first diameter being greater than the second diameter.

[0143] Example 14. The implantable prosthesis of any of the examples herein, particularly any one of Examples 1-12, wherein when the frame is in a radially expanded configuration, the frame has a first diameter at a first location on the frame and a second diameter at a second location on the frame axially spaced from the first location, the first and second diameters being substantially equal such that the frame has a cylindrical shape.

[0144] Example 15. The implantable prosthesis of any of the examples herein, particularly any one of Examples 1-14, further comprising a valve assembly including a plurality of leaflets attached inside the frame.

[0145] Example 16. The implantable prosthesis of any of the examples herein, particularly any one of Examples 1-15, wherein the plurality of struts includes a plurality of inner struts and a plurality of outer struts pivotally connected to the inner struts at a plurality of pivot joints.

[0146] Example 17. An implantable prosthesis including a frame having first and second opposing axial ends. The frame includes a plurality of medial and lateral struts pivotally coupled to one another at a plurality of joints. Each strut has a first portion and a second portion, the first portion forming a convex curve facing the first end of the frame and the second portion forming a concave curve facing the first end of the frame.

[0147] Example 18. The implantable prosthesis of any example herein, particularly example 17, wherein the projection of each strut in a plane parallel to the longitudinal axis of the frame is curved.

[0148] Example 19. The implantable prosthesis of any of the examples herein, particularly Example 17 or Example 18, wherein the first and second portions each include a plurality of segments, each segment of the first portion being offset in a first direction from each adjacent segment such that the first portion is curved along the length of the first portion, and each segment of the second portion being offset in a second direction from each adjacent segment such that the second portion is curved along the length of the second portion.

[0149] Example 20. An implantable prosthesis including a radially expandable and compressible frame having an inflow end and an outflow end. The frame includes a plurality of first struts extending in a first direction and a plurality of second struts extending in a second direction and coupled to the first plurality of struts at a plurality of joints. A first set of selected joints are configured as fixed joints and a second set of selected joints are configured as pivotable joints. Each fixed joint includes a fastener configured to couple a respective first strut and second strut to one another such that the respective first and second struts can pivot relative to one another about the fastener. Each pivotable joint includes a protrusion extending from a surface of the respective second strut, the protrusion being disposed within a corresponding recess in the surface of the respective first strut such that the respective first and second struts can pivot relative to one another about the protrusion.

[0150] Example 21 The implantable device of any of the examples herein, particularly example 20, wherein the plurality of second struts are disposed radially inward of the plurality of first struts.

[0151] Example 22. The implantable device of any of the examples herein, particularly Example 20 or Example 21, wherein each strut includes a plurality of straight segments connected to one or more adjacent straight segments via one or more intermediate segments.

[0152] Example 23. The implantable device of any one of the examples herein, particularly any one of Examples 20-22, wherein each first strut is coupled to one or more second struts via first and second fixation joints adjacent the inflow end of the frame and third and fourth fixation joints adjacent the outflow end of the frame.

[0153] Example 24. The implantable device of any one of the examples herein, particularly any one of Examples 20-23, wherein each first strut is coupled to one or more second struts via seven joints, four joints being fixed joints and three joints being pivotable joints.

[0154] Example 25. The implantable device of any of the examples herein, particularly any one of Examples 20-24, wherein each first strut includes one or more openings extending through the thickness of the strut and one or more recessed portions having a dome-shaped shape.

[0155] Example 26. The implantable device of any of the examples herein, particularly any one of Examples 20-25, wherein each second strut includes one or more fasteners extending from a surface of the strut and one or more protrusions extending from a surface of the strut.

[0156] Example 27 The implantable device of any of the examples herein, particularly any one of Examples 20-26, wherein each protrusion has a hemispherical shape.

[0157] Example 28 The implantable device of any one of the examples herein, particularly any one of Examples 20-27, wherein each fastener has a cylindrical shape with flanged ends.

[0158] Example 29. The implantable device of any one of the examples herein, particularly any one of Examples 20-28, wherein each fastener further comprises an inner bore.

[0159] Example 30. The implantable device of any of the examples herein, particularly any one of Examples 20-29, wherein each fastener and each protrusion is disposed on a respective intermediate segment.

[0160] Example 31 The implantable device of any one of the examples herein, particularly any one of Examples 20-30, wherein the anchor is integrally formed with the second strut.

[0161] Example 32 The implantable device of any of the examples herein, particularly any one of Examples 20-31, wherein the protrusion is integrally formed with the second strut.

[0162] Example 33. The implantable device of any of the examples herein, particularly any one of Examples 20-32, wherein each second strut includes a plurality of segments connected to one or more adjacent segments via one or more intermediate segments, and each intermediate segment includes at least one of an opening extending through the thickness of the strut and a protrusion extending from a surface of the strut.

[0163] Example 34. The implantable device of any of the Examples herein, particularly any one of Examples 20-33, wherein each strut extends from a first end of the frame to an axially opposite second end of the frame.

[0164] Example 35 The implantable device of any of the examples herein, particularly any one of Examples 20-34, further comprising a valve assembly including a plurality of leaflets attached inside the frame.

[0165] Example 36. An implantable prosthesis including a radially expandable and compressible frame having an inflow end and an outflow end. The frame includes a plurality of first struts extending in a first direction, each first strut including a plurality of linear segments coupled to one or more adjacent linear segments via one or more intermediate segments. Each first strut includes at least one aperture extending through the thickness of the first strut at the intermediate segment and at least one recess extending into the thickness of the first strut at an additional intermediate segment. The frame further includes a plurality of second struts extending in a second direction and coupled to the plurality of first struts at a plurality of joints. Each second strut includes a plurality of linear segments coupled to one or more adjacent linear segments via one or more intermediate segments. Each second strut includes at least one fastener extending from a surface of the strut at the intermediate segment and at least one protrusion extending from a surface of the strut at an additional intermediate segment. Selected joints of the plurality of joints are configured as fixed joints and selected joints are configured as pivotable joints.

[0166] Example 37. The implantable device of any of the examples herein, particularly example 36, wherein a respective fastener of each second strut at each fixation joint extends through a respective opening of a respective first strut to couple the first and second struts to one another and allow the first and second struts to pivot relative to one another about the fastener.

[0167] Example 38. The implantable device of any of the examples herein, particularly Example 36 or Example 37, wherein at each pivotable joint a respective protrusion of a respective second strut is disposed within a respective recess of a respective first strut, such that the first and second struts can pivot relative to one another about the protrusion.

[0168] Example 39. The implantable device of any of the examples herein, particularly any one of Examples 36-38, wherein the plurality of second struts are disposed radially inward of the plurality of first struts.

[0169] Example 40. The implantable device of any of the examples herein, particularly any one of Examples 36-38, wherein each first strut is coupled to one or more second struts via first and second fixation joints adjacent the inflow end of the frame and third and fourth fixation joints adjacent the outflow end of the frame.

[0170] Example 41. The implantable device of any one of the examples herein, particularly any one of Examples 36-40, wherein each first strut is coupled to one or more second struts via seven joints, four joints being fixed joints and three joints being pivotable joints.

[0171] Example 42 The implantable device of any one of the examples herein, particularly any one of Examples 36-41, wherein each depression has a hemispherical shape.

[0172] Example 43. The implantable device of any of the examples herein, particularly any one of Examples 36-42, wherein each protrusion has a hemispherical shape.

[0173] Example 44 The implantable device of any one of the examples herein, particularly any one of Examples 36-43, wherein each fastener has a cylindrical shape with flanged ends.

[0174] Example 45. The implantable device of any of the examples herein, particularly any one of Examples 36-44, wherein each fastener further comprises an inner bore.

[0175] Example 46 The implantable device of any of the examples herein, particularly any one of Examples 36-45, wherein the anchor and the protrusion are integrally formed with the second strut.

[0176] Example 47 The implantable device of any of the examples herein, particularly any one of Examples 36-46, wherein each strut extends from a first end of the frame to an axially opposite second end of the frame.

[0177] Example 48. The implantable device of any of the examples herein, particularly any one of Examples 36-47, further comprising a valve assembly including a plurality of leaflets attached inside the frame.

[0178] Example 49. An implantable prosthesis including a radially expandable and compressible frame having an inflow end and an outflow end. The frame includes a plurality of first struts extending in a first direction, each first strut including at least one first aperture extending through a thickness of the first strut and a first recess disposed about the first aperture. The frame further includes a plurality of second struts extending in a second direction, each second strut including at least one second aperture extending through a thickness of the second strut and a second recess disposed about the second aperture. The frame further includes a plurality of fasteners, each fastener extending through a respective first aperture and a respective second aperture to couple a respective first and second strut to one another at a joint. Each fastener includes a body portion, a head portion sized to retain the fastener in the second recess, and a flanged end sized to retain the fastener in the first recess.

[0179] Example 50 The implantable device of any of the examples herein, particularly example 49, wherein each fastener includes an internal bore extending along at least a portion of the length of the fastener.

[0180] Example 51. The implantable device of any of the examples herein, particularly Example 49 or Example 50, wherein each flanged end is formed using a punch member that applies a force to the first opening of the inner bore to plastically deform the flanged end.

[0181] Example 52 The implantable device of any of the examples herein, particularly example 49, wherein each fastener is a solid piece of material.

[0182] Example 53 The implantable device of any example herein, particularly example 52, wherein each flanged end is formed by radial riveting.

[0183] Example 54. The implantable device of any of the examples herein, particularly any one of Examples 49-53, wherein the first recess is sized such that the flanged end does not extend beyond the radially outer surface of the first strut.

[0184] Example 55. A method comprising inserting a fastener through a first opening in a first strut and a second opening in a second strut, the fastener including a body portion having a first diameter, a head portion having a second diameter greater than the first diameter, and an end portion. The method further comprises disposing the head portion of the fastener in a recess surrounding the second opening, the recess being disposed in a radially inner surface of the second strut, and deforming the end portion of the fastener to form a flanged head portion disposed in an additional recess surrounding the first opening to couple the first and second struts to one another and enable the first and second struts to pivot relative to one another about the fastener.

[0185] Example 56. The method of any of the examples herein, particularly Example 55, wherein the fastener includes an internal bore extending at least partially along a length of the fastener, and the step of deforming the end of the fastener includes applying a force to the end with a punch member to deform the end from a first diameter to a second diameter greater than the first diameter.

[0186] Example 57. The method of any example herein, particularly example 55, wherein the step of deforming the end of the fastener includes radially riveting the end to deform the end from a first diameter to a second diameter greater than the first diameter.

[0187] Example 58. An implantable prosthesis including a radially expandable and compressible frame having an inflow end and an outflow end. The frame includes a plurality of first struts extending in a first direction, each first strut including at least one aperture extending through a thickness of the first strut and a recess disposed about the aperture. The frame further includes a plurality of second struts extending in a second direction, each second strut including at least one fastener extending from a surface of the second strut, each fastener extending through a respective aperture to couple a respective first and second strut to one another at a joint. Each fastener includes a body portion and a flanged end sized to retain the fastener within the recess.

[0188] Example 59 The implantable device of any of the examples herein, particularly example 58, wherein each fastener includes an internal bore extending along at least a portion of the length of the fastener.

[0189] Example 60. The implantable device of any of the examples herein, particularly example 59, wherein each flanged end is formed using a punch member that applies a force to the first opening of the inner bore to plastically deform the flanged end.

[0190] Example 61 The implantable device of any of the examples herein, particularly example 58, wherein each fastener is a solid piece of material.

[0191] Example 62. The implantable device of any example herein, particularly example 61, wherein each flanged end is formed by radial riveting.

[0192] Example 63. The implantable device of any of the examples herein, particularly any one of Examples 58-62, wherein the recess is sized such that the flanged end does not extend beyond the radially outer surface of the first strut.

[0193] Example 64. A method comprising the steps of inserting a fastener through an opening in a first post, the fastener extending from a radially outer surface of the second post, and deforming an end of the fastener to form a flanged head portion disposed in a recess surrounding the opening to couple the first and second posts to one another and enable the first and second posts to pivot relative to one another about the fastener, the recess being disposed in the radially outer surface of the first post.

[0194] Example 65. The method of any of the examples herein, particularly Example 64, wherein the fastener includes an internal bore extending at least partially along a length of the fastener, and the step of deforming the end of the fastener includes applying a force to the end with a punch member to deform the end from a first diameter to a second diameter greater than the first diameter.

[0195] Example 66. The method of any example herein, particularly Example 64, wherein the step of deforming the end of the fastener includes radially riveting the end to deform the end from a first diameter to a second diameter greater than the first diameter.

[0196] Example 67. An implantable prosthesis including a radially expandable and compressible frame having an inflow end and an outflow end. The frame includes a plurality of first struts extending in a first direction, each first strut including at least one aperture extending through a thickness of the first strut and a recess disposed about the aperture. The frame further includes a plurality of second struts extending in a second direction, each second strut including at least one fastener extending from a surface of the second strut through a respective aperture in the first strut. Each fastener includes a body portion, a projection, and an internal slot extending at least partially along a length of the fastener, the fastener being movable between a compressed configuration and an uncompressed configuration. When in the uncompressed configuration, the projection is sized to retain the fastener within the respective aperture to couple the first and second struts to one another and to allow the first and second struts to pivot relative to one another about the fastener.

[0197] Example 68. The implantable device of any of the examples herein, particularly example 67, wherein the protrusion is disposed within the recess such that the protrusion does not extend beyond the radially outer surface of the first strut.

[0198] Example 69 The implantable device of any of the examples herein, particularly example 67 or example 68, wherein the protrusions have a larger diameter than the body portion and the openings when in the uncompressed configuration.

[0199] Example 70. A method comprising the steps of: pressing a fastener against an aperture in a first strut, the fastener extending from a radially outer surface of a second strut and including a body portion, a protrusion, and an internal slot extending at least partially along a length of the fastener, the protrusion having a diameter greater than a diameter of the aperture. The method further comprises the steps of advancing the fastener through the aperture such that the fastener moves from an uncompressed configuration to a compressed configuration, and allowing the fastener to resiliently expand to the uncompressed configuration once the protrusion emerges from a radially outer end of the aperture such that the fastener is retained within the aperture coupling the first and second struts to one another such that the first and second struts can pivot relative to one another about the fastener.

[0200] In view of the many possible embodiments to which the principles of the present disclosure may be applied, it should be recognized that the illustrated embodiments are merely examples and should not be construed as limiting the scope of the disclosure or the claims, rather, the scope of the claimed subject matter is defined by the following claims and their equivalents. [Explanation of symbols]

[0201] 10 Prosthetic valves 12 Frames 14 Inlet end 16 Outlet end 18 Valve Structure 20 leaflets 22 Inflow edge 24 Posts 24a Inner strut 24b Outer strut 26 Longitudinal axis 28 Joint 30 aperture 32 Vertex 34 Vertex 36 Cells 38 Fixtures 50 Actuator 52 Rod 54 Sleeve 56 Nut 58 Mounting material 60 notches 62 Protrusion 64 Interlocking attachment member 70 Outer Skirt 100 Prosthetic valve 104 Frames 150 Distal Junction 152 Distal Apex 160 Proximal Junction 162 Proximal Apex 200 Extending and Locking Mechanism 202 Actuator screw 204 Distal part 206 Proximal part 208 Distal mounting parts 210 Distal Valve Connector 212 Sleeve 214 Proximal Valve Connector 216 Lock nut 218 Notch part 219 Engagement surface 220 Support tube 222 Actuator member 224 Rock Tools 226 Notch part 227 Engagement surface 300 Prosthetic Valves 302 Frames 302' Frame 304 Inflow end 306 Outlet end 308 Post 310 Cell 310a first row of cells 310b second row of cells 310c Third row of cells 310d Fourth row of cells 310e 5th cell row 312 Aperture 314 Segments 314a Segment 314b Segment 314c Segment 314d Segment 314e Segment 314f Segment 316 Coordinate Systems 318 Mid Segment 320 End 322 Vertex 324 First Part 326 Second Part 328 Deflection Point 400 Prosthetic Valve 402 Frames 404 Inflow end 406 Outlet end 408 Post 410 First Part 412 Second Part 414 Deflection point 416 Cells 416a 1st row of cells 416b Second row of cells 416c Third cell row 416d Fourth row of cells 416e 5th cell row 500 Prosthetic Valve 502 frames 504 First Pillar 506 Second Pillar 508 Joint 508a joint 508b joint 508c joint 508d joint 508e joint 508f joint 508g joint 510 Inlet end 512 Outflow end 514 Fixed joint 516 Pivotable joint 518 Valve Structure 520 Extension and Locking Mechanism 522 Inner Skirt 524 Fixtures 526 Radial outer surface 528 Body 530 inner bore 532 Aperture 534 End 536 Flanged Ends 538 Protrusion 540 Socket 542 Radial outer surface 544 Straight Segment 546 Mid Segment 600 First Pillar 602 Second Pillar 604 Joint 606 Fixtures 608 Main body part 610 Head part 612 Inner bore 614 End 616 Flanged Ends 618 First Opening 620 Second Opening 622 First Hole 624 Second Hole 626 Radial outer surface 628 Radial inner surface 630 Counterbore 632 base 634 Side wall 636 Countersink 700 First Pillar 702 Second Pillar 704 Joint 706 Fixtures 708 Aperture 710 Aperture 712 Main body part 714 Head part 716 Radial outer end face 718 Flanged Ends 720 Riveting materials 722 First Hole 724 Second Hole 726 Radial outer surface 728 Radial inner surface 800 First Pillar 802 Second Pillar 804 Joint 806 Fixtures 808 Straight Segment 810 Middle part 814 Surface 816 Aperture 818 Depression 820 End 822 flanged ends 824 Radial outer surface 900 First Pillar 902 Second Pillar 904 Joint 906 Fixtures 908 Inner Slot 910 Main body part 912 Protrusion 914 Aperture 918 Depression 920 Radial outer surface

Claims

1. a frame that is radially expandable and compressible between a radially compressed configuration and a radially expanded configuration; the frame includes a plurality of struts, each strut including a first portion and a second portion separated by a deflection point; each strut is helically curved relative to a first longitudinal axis of the frame; the first portion of each strut is curved in a first direction relative to a first line parallel to a second axis that is perpendicular to the first longitudinal axis of the frame; The second portion of each strut is curved in a second direction relative to a second line parallel to the second axis.

2. The implantable prosthesis of claim 1 , wherein the first portion of the strut is convex relative to an outflow end of the frame.

3. 3. The implantable prosthesis of claim 1 or 2, wherein the second portion of the strut is concave relative to the outflow end of the frame.

4. 4. The implantable prosthesis of claim 1, wherein the first portion of the strut is positioned adjacent an inflow end of the frame and the second portion is positioned adjacent an outflow end of the frame.

5. 4. The implantable prosthesis of claim 1, wherein the first portion of the strut is positioned adjacent an outflow end of the frame and the second portion is positioned adjacent an inflow end of the frame.

6. The implantable prosthesis of claim 1 , wherein the first and second portions have equal lengths.

7. 6. The implantable prosthesis of claim 1, wherein the first portion has a first length and the second portion has a second length, the first length being greater than the second length.

8. 6. The implantable prosthesis of claim 1, wherein the first portion has a first length and the second portion has a second length, the second length being greater than the first length.

9. 9. The implantable prosthetic device of any one of claims 1 to 8, wherein the plurality of struts includes a first set of a plurality of struts extending in a first direction and a second set of a plurality of struts extending in a second direction, each strut of the first set of struts connected to at least one strut of the second set of struts to form a plurality of cells.

10. 10. The implantable prosthesis of claim 9, wherein the plurality of cells includes a first row of cells adjacent a first end of the frame and a second row of cells disposed between the first end and a second end of the frame, the first row of cells being smaller than the second row of cells.

11. 11. The implantable prosthesis of claim 10, further comprising a third row of cells adjacent the second end of the frame, the third row of cells being smaller than the second row of cells.

12. 12. The implantable prosthesis of any one of claims 1-11, wherein each strut extends from a first end of the frame to an axially opposite second end of the frame.

13. 13. The implantable prosthesis of any one of claims 1 to 12, wherein when the frame is in the radially expanded configuration, the frame tapers from a first diameter at a first location on the frame to a second diameter at a second location on the frame axially spaced from the first location, the first diameter being greater than the second diameter.

14. 13. The implantable prosthesis of any one of claims 1 to 12, wherein when the frame is in the radially expanded configuration, the frame has a first diameter at a first location on the frame and a second diameter at a second location on the frame axially spaced from the first location, the first diameter and the second diameter being substantially equal such that the frame has a cylindrical shape.

15. 15. The implantable prosthesis of any one of claims 1 to 14, further comprising a valve assembly including a plurality of leaflets attached inside the frame.

16. 16. The implantable prosthesis of any one of claims 1-15, wherein the plurality of struts includes a plurality of inner struts and a plurality of outer struts pivotally coupled to the inner struts at a plurality of pivot joints.

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