WO2023183270A1

WO2023183270A1 - Mechanically expandable prosthetic heart valve

Info

Publication number: WO2023183270A1
Application number: PCT/US2023/015707
Authority: WO
Inventors: Anatoly Dvorsky; Eran GROSU; Ilan LESHECZ; Nikolai Gurovich; Michael BUKIN; Joseph Mordechai LEICHNER; Elazar Levi SCHWARCZ; Alon Ben-Yosef
Original assignee: Edwards Lifesciences Corporation
Priority date: 2022-03-24
Filing date: 2023-03-20
Publication date: 2023-09-28

Abstract

A prosthetic heart valve includes a radially expandable and compressible frame having a pair of axially extending frame members including a first frame member and a second frame member axially spaced from the first frame member. The first frame member defines a window, and a threaded nut is received in the window. A threaded rod extends through the first and second frame members and through the nut in the window, wherein threads of the rod engage threads of the nut and rotation of the threaded rod in a first direction produces radial expansion of the frame from a radially compressed state to a radially expanded state. A valvular structure is disposed within the frame and configured to regulate blood flow through the frame. The window is sized to permit the nut to travel axially within the window between a first axial position and a second axial position.

Description

MECHANICALLY EXPANDABLE PROSTHETIC HEART VALVE

CROSS REFERENCE TO RELATED APPLICATION

[001] The present application claims the benefit of U.S. Provisional Application No. 63/323.415, filed March 24, 2022. U.S. Provisional Application No. 63/323.415 is incorporated herein by reference in its entirety.

FIELD

[002] The present disclosure relates to implantable, mechanically expandable prosthetic devices, such as prosthetic heart valves, and to improved expansion mechanisms for such prosthetic heart valves.

BACKGROUND

[003] The human heart can suffer from various valvular diseases. These valvular diseases can result in significant malfunctioning of the heart and ultimately require repair of the native valve or replacement of the native valve with an artificial valve. There are a number of known repair devices (e.g., stents) and artificial valves, as well as a number of known methods of implanting these devices and valves in humans. Percutaneous and minimally- invasive surgical approaches are used in various procedures to deliver prosthetic medical devices to locations inside the body that are not readily accessible by surgery or where access without surgery is desirable. In one specific example, a prosthetic heart valve can be mounted in a crimped state on the distal end of a delivery apparatus and advanced through the patient’s vasculature (e.g., through a femoral artery and the aorta) until the prosthetic heart valve reaches the implantation site in the heart. The prosthetic heart valve is then expanded to its functional size, for example, by inflating a balloon on which the prosthetic valve is mounted, actuating 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 apparatus so that the prosthetic heart valve can self-expand to its functional size.

[004] 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-expandable and balloonexpandable prosthetic heart valves. For example, mechanically expandable prosthetic heart valves can be expanded to various diameters. Mechanical] valves can also be collapsed and/or compressed after an initial expansion (e.g., for repositioning and/or retrieval). However, in the collapsed state members of the frame can experience compressive forces that can cause the frame members to bow or buckle outwardly. Accordingly, there remains a need for improved transcatheter heart valves.

SUMMARY

[005] Embodiments of the present disclosure concern prosthetic heart valves, such as mechanically-expandable prosthetic heart valves with expansion mechanisms including screw actuators comprising an actuator member such as a threaded rod disposed through a frame member of the prosthetic heart valve. The threaded rod can extend through a force transmission member such as a threaded nut, which can be positioned in an opening defined in the frame member of the prosthetic heart valve. Actuation of the threaded rod can move the prosthetic heart valve between the expanded configuration and the collapsed or compressed configuration. As the prosthetic heart valve expands and collapses the threaded nut can move axially within the window to reduce stress on the threaded rod to reduce the risk of buckling.

[006] In a representative embodiment, a prosthetic heart valve can comprise a radially expandable and compressible frame comprising a pair of axially extending frame members including a first frame member and a second frame member axially spaced from the first frame member, the first frame member defining a window. A threaded nut can be received in the window of the first frame member, and a threaded rod can extend through the first and second frame members and through the threaded nut in the window. Threads of the rod can engage threads of the threaded nut, and rotation of the threaded rod in a first direction produces radial expansion of the frame from a radially compressed state to a radially expanded state. A valvular structure is disposed within the frame and configured to regulate blood flow through the frame. The window is sized to permit the threaded nut to travel axially within the window between a first axial position and a second axial position.

[007] In another representative embodiment, a prosthetic heart valve comprises a radially expandable and compressible frame comprising a pair of axially extending frame members including a first frame member and a second frame member axially spaced from the first frame member, the first frame member defining a window. A threaded nut is received in the window of the first frame member, and a threaded rod exh frame members and through the threaded nut in the window. Threads of the threaded rod engage threads of the threaded nut and rotation of the threaded rod in a first direction produces radial expansion of the frame from a radially compressed state to a radially expanded state. A valvular structure is disposed within the frame and configured to regulate blood flow through the frame. The threaded nut comprises a guide member positioned outside the window that at least partially covers the window.

[008] In another representative embodiment, a method comprises collapsing a prosthetic heart valve from a radially expanded state to a radially collapsed state by rotating a threaded rod, the threaded rod extending through a first frame member and through a second frame member that is axially spaced from the first frame member and engaging a threaded nut positioned in a window defined in the first frame member, rotation of the threaded rod moving the threaded nut from a proximal position in the window to a distal position in the window.

[009] In another representative embodiment, a prosthetic heart valve comprises a radially expandable and compressible annular frame, a valvular structure disposed within the frame and configured to regulate blood flow through the frame, and an actuator assembly coupled to the frame and configured to apply force to the frame to radially expand or compress the frame. The actuator assembly comprises an axially extending frame member, the frame member defining a window, an actuator member extending through the frame member and through the window, and a force transmission member coupled to the actuator member and received in the window of the frame member. Motion of the actuator member in a first direction produces radial expansion of the frame from a radially compressed state to a radially expanded state, and the window of the frame member is sized to permit the force transmission member to travel axially within the window between a first axial position and a second axial position.

[010] The foregoing and other objects, features, and advantages of the disclosed technology will become more apparent from the following detailed description, which proceeds with reference to the accompanying figures. BRIEF DESCRIPTION OF THE

[Oil] FIG. 1 A is a perspective view of one example of a prosthetic valve including a frame and a plurality of leaflets attached to the frame.

[012] FIG. IB is a perspective view of the prosthetic valve of FIG. 1 A with an outer skirt disposed around the frame.

[013] FIG. 2A is a perspective view of a frame for the prosthetic valve of FIG. 1A.

[014] FIG. 2B is a front portion of the frame shown in FIG. 2A.

[015] FIG. 3 is a side elevation view of a delivery apparatus for a prosthetic device, such as a prosthetic valve, according to one example.

[016] FIG. 4 is a perspective view of a portion of an actuator of the prosthetic device of FIGS. 1A-2B and an actuator assembly of a delivery apparatus, according to one example.

[017] FIG. 5 is a perspective view of the actuator and actuator assembly of FIG. 4 with the actuator assembly physically coupled to the actuator.

[018] FIG. 6 is a side elevation view of a portion of an actuator mechanism including a post defining a window with an axial dimension that is greater than a thickness of the nut received in the window.

[019] FIG. 7 is a magnified side elevation view of the actuator mechanism of FIG. 6 illustrating the nut in a proximal position in the window.

[020] FIG. 8 is a magnified side elevation view of the actuator mechanism of FIG. 6 illustrating the nut in a distal position in the window.

[021] FIG. 9 is a perspective view of a nut, according to one example.

[022] FIG. 10 is a magnified side elevation view of the window in the post of FIG. 6 illustrating gaps between the side walls of the nut and the side walls of the window.

[023] FIG. 11 is a magnified side elevation view of the window in the post of FIG. 6 illustrating a nut in the window that has the same width as the window.

[024] FIGS. 12 and 13 are magnified perspective views of the actuator mechanism of FIG. 6 illustrating various examples of nuts including flanges on the outside of the post. [025] FIG. 14 is a top plan view of a nut including a plur example.

DETAILED DESCRIPTION

Explanation of Terms

[026] For purposes of this description, certain aspects, advantages, and novel features of examples of this disclosure are described herein. The disclosed methods, apparatus, and systems should not be construed as being limiting in any way. Instead, the present disclosure is directed toward all novel and nonobvious features and aspects of the various disclosed examples, alone and in various combinations and sub-combinations with one another. The methods, apparatus, and systems are not limited to any specific aspect or feature or combination thereof, nor do the disclosed examples require that any one or more specific advantages be present or problems be solved.

[027] Although the operations of some of the disclosed examples are described in a particular, sequential order for convenient presentation, it should be understood that this manner of description encompasses rearrangement, unless a particular ordering is required by specific language set forth below. For example, operations described sequentially may in some cases be rearranged or performed concurrently. Moreover, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed methods can be used in conjunction with other methods. Additionally, the description sometimes uses terms like “provide” or “achieve” to describe the disclosed methods. These terms are high-level abstractions of the actual operations that are performed. The actual operations that correspond to these terms may vary depending on the particular implementation and are readily discernible by one of ordinary skill in the art.

[028] As used in this application and in the claims, the singular forms “a,” “an,” and “the” include the plural forms unless the context clearly dictates otherwise. Additionally, the term “includes” means “comprises.” Further, the term “coupled” generally means physically, mechanically, chemically, magnetically, and/or electrically coupled or linked and does not exclude the presence of intermediate elements between the coupled or associated items absent specific contrary language. [029] As used herein, the term “proximal” refers to a pos device that is closer to the user and further away from the implantation site. As used herein, the term “distal” refers to a position, direction, or portion of a device that is further away from the user and closer to the implantation site. Thus, for example, proximal motion of a device is motion of the device away from the implantation site and toward the user (e.g., out of the patient’s body), while distal motion of the device is motion of the device away from the user and toward the implantation site (e.g., into the patient’s body). The terms “longitudinal” and “axial” refer to an axis extending in the proximal and distal directions, unless otherwise expressly defined.

Overview of the Disclosed Technology

[030] Prosthetic valves disclosed herein can be radially compressible and expandable between a radially compressed state and a radially expanded state. Thus, the prosthetic valves can be crimped on or retained by an implant delivery apparatus in the radially compressed state while being advanced through a patient’s vasculature on the delivery apparatus. The prosthetic valve can be expanded to the radially expanded state once the prosthetic valve reaches the implantation site. It is understood that the prosthetic valves disclosed herein may be used with a variety of implant delivery apparatuses and can be implanted via various delivery procedures, examples of which will be discussed in more detail later.

[031] FIGS. 1A-2B illustrate an exemplary prosthetic device (e.g., prosthetic heart valve) that can be advanced through a patient’s vasculature, such as to a native heart valve, by a delivery apparatus, such as the exemplary delivery apparatus shown in FIG. 3. The frame of the prosthetic heart valve can include one or more mechanical expansion and locking mechanisms that can be integrated into the frame - specifically, into axially extending posts of the frame. The mechanical expansion and/or locking mechanisms can be removably coupled to, and/or actuated by, the delivery apparatus to radially expand the prosthetic heart valve and lock the prosthetic heart valve in one or more radially expanded states.

[032] In some examples, axial frame members or posts of the prosthetic heart valve can define an opening referred to herein as a window. An actuator member such as a threaded rod extending through the post can extend through the window. A force transmission member such as a threaded nut can be disposed around the within the window. The axial length of the window can be greater than the axial thickness of the threaded nut such that the nut and the post can move axially relative to each other as the prosthetic heart valve radially expands and collapses. During such motion the axial position of the nut on the threaded rod need not change. This can relieve compressive and/or tensile force on the threaded rod associated with radially expanding and collapsing the prosthetic heart valve.

[033] In addition, in some examples the threaded nut can comprise a material with a lower hardness than the threaded rod, such as a polymeric material. This can facilitate motion of the threaded nut within the window of the post, and can also reduce wear of the threads of the rod. In some examples, the threaded nuts can also comprise guides such as flanges disposed on the radially outward and/or radially inward surfaces of the posts. The guides can guide motion of the threaded nut within the window, and/or cover the window to prevent the prosthetic valve leaflets and/or surrounding natural tissue from becoming caught in the window.

Example 1: Mechanically Expandable Prosthetic Heart Valve

[034] FIGS. 1A-2B show an exemplary prosthetic valve 100, according to one example. Any of the prosthetic valves disclosed herein are adapted to be implanted in the native aortic annulus, although in other examples they can be adapted to be implanted in the other native annuluses of the heart (the pulmonary, mitral, and tricuspid valves). The disclosed prosthetic valves also can be implanted within vessels communicating with the heart, including a pulmonary artery (for replacing the function of a diseased pulmonary valve, or the superior vena cava or the inferior vena cava (for replacing the function of a diseased tricuspid valve) or various other veins, arteries and vessels of a patient. The disclosed prosthetic valves also can be implanted within a previously implanted prosthetic valve (which can be a prosthetic surgical valve or a prosthetic transcatheter heart valve) in a valve-in-valve procedure.

[035] In some examples, the disclosed prosthetic valves can be implanted within a docking or anchoring device that is implanted within a native heart valve or a vessel. For example, in one example, the disclosed prosthetic valves can be implanted within a docking device implanted within the pulmonary artery for replacing the fu valve, such as disclosed in U.S. Publication No. 2017/0231756, which is incorporated by reference herein. In another example, the disclosed prosthetic valves can be implanted within a docking device implanted within or at the native mitral valve, such as disclosed in PCT Publication No. W02020/247907, which is incorporated herein by reference. In another example, the disclosed prosthetic valves can be implanted within a docking device implanted within the superior or inferior vena cava for replacing the function of a diseased tricuspid valve, such as disclosed in U.S. Publication No. 2019/0000615, which is incorporated herein by reference.

[036] FIGS. 1A-2B illustrate an example of a prosthetic valve 100 (which also may be referred to herein as “prosthetic heart valve 100”) having a frame 102. FIGS. 2A-2B show the frame 102 by itself, while FIGS. 1A-1B show the frame 102 with a valvular structure 150 (which can comprise leaflets 158, as described further below) mounted within and to the annular frame 102. FIG. IB additionally shows an optional skirt assembly comprising an outer skirt 103. While only one side of the frame 102 is depicted in FIG. 2B, it should be appreciated that the frame 102 forms an annular structure having an opposite side that is substantially identical to the portion shown in FIG. IB, as shown in FIGS. 1A-2A.

[037] As shown in FIGS. 1A and IB, the valvular structure 150 is coupled to and supported inside the frame 102. The valvular structure 150 is configured to regulate the flow of blood through the prosthetic valve 100, from an inflow end portion 134 to an outflow end portion 136. The valvular structure 150 can include, for example, a leaflet assembly comprising one or more leaflets 158 made of flexible material. The leaflets 158 can be made from in whole or part, biological material, bio-compatible synthetic materials, or other such materials.

Suitable biological material can include, for example, bovine pericardium (or pericardium from other sources). The leaflets 158 can be secured to one another at their adjacent sides to form commissures 152, each of which can be secured to a respective commissure support structure 144 (also referred to herein as “commissure supports”) and/or to other portions of the frame 102, as described in greater detail below.

[038] In the example depicted in FIGS. 1A and IB, the valvular structure 150 includes three leaflets 158, which can be arranged to collapse in a tricuspid arrangement. Each leaflet 158 can have an inflow edge portion 160 (which can also be referred to as a cusp edge portion) (FIG. 1A). The inflow edge portions 160 of the leaflets 15 scallop edge that generally follows or tracks portions of struts 112 of frame 102 in a circumferential direction when the frame 102 is in the radially expanded configuration. The inflow edge portions 160 of the leaflets 158 can be referred to as a “scallop line.”

[039] The prosthetic valve 100 may include one or more skirts mounted around the frame 102. For example, as shown in FIG. IB, the prosthetic valve 100 may include an outer skirt 103 mounted around an outer surface of the frame 102. The outer skirt 103 can function as a sealing member for the prosthetic valve 100 by sealing against the tissue of the native valve annulus and helping to reduce paravalvular leakage past the prosthetic valve 100. In some cases, an inner skirt (not shown) may be mounted around an inner surface of the frame 102. The inner skirt can function as a sealing member to prevent or decrease perivalvular leakage, to anchor the leaflets 158 to the frame 102, and/or to protect the leaflets 158 against damage caused by contact with the frame 102 during crimping and during working cycles of the prosthetic valve 100. In some examples, the inflow edge portions 160 of the leaflets 158 can be sutured to the inner skirt generally along the scallop line. The inner skirt can in turn be sutured to adjacent struts 112 of the frame 102. In other examples, as shown in FIG. 1 A, the leaflets 158 can be sutured directly to the frame 102 or to a reinforcing member 125 (also referred to as a reinforcing skirt or connecting skirt) in the form of a strip of material (e.g., a fabric strip) which is then sutured to the frame 102, along the scallop line via stitches (e.g., whip stitches) 133.

[040] The inner and outer skirts and the connecting skirt 125 can be formed from any of various suitable biocompatible materials, including any of various synthetic materials, including fabrics (e.g., polyethylene terephthalate fabric) or natural tissue (e.g., pericardial tissue). Further details regarding the use of skirts or sealing members in prosthetic valve can be found, for example, in U.S. Patent Publication No. 2020/0352711, which is incorporated herein by reference.

[041] Further details regarding the assembly of the leaflet assembly and the assembly of the leaflets and the skirts to the frame can be found, for example, in PCT Publication No. WO2022/261419, and PCT Publication No. W02023/003696, which are incorporated herein by reference. Further details of the construction and function of the frame 102 can be found in PCT Publication No. WO2022/072564, which is incorporated herein by reference. [042] The frame 102, which is shown alone and in greate comprises an inflow end 109, an outflow end 108, and a plurality of axially extending posts 104. The axial direction of the frame 102 is indicated by a longitudinal axis 105, which extends from the inflow end 109 to the outflow end 108 (FIGS. 2A and 2B). Some of the posts 104 can be arranged in pairs of axially aligned first and second struts or posts 122, 124. An actuator 126 (such as the illustrated threaded rod or bolt) can extend through one or more pairs of posts 122, 124 to form an integral expansion and locking mechanism or actuator mechanism 106 configured to radially expand and compress the frame 102, as further described below. One or more of posts 104 can be configured as support posts 107.

[043] The actuator mechanisms 106 (which can be used to radially expand and/or radially compress the prosthetic valve 100) can be integrated into the frame 102 of the prosthetic valve 100, thereby reducing the crimp profile and/or bulk of the prosthetic valve 100. Integrating the actuator mechanisms 106 (which can also be referred to herein as “expansion and locking mechanisms”) into the frame 102 can also simplify the design of the prosthetic valve 100, making the prosthetic valve 100 less costly and/or easier to manufacture. In the illustrated example, an actuator 126 extends through each pair of axially aligned posts 122, 124. In other examples, one or more of the pairs of posts 122, 124 can be without a corresponding actuator.

[044] The posts 104 can be coupled together by a plurality of circumferentially extending link members or struts 112. Each strut 112 extends circumferentially between adjacent posts 104 to connect all of the axially extending posts 104. As one example, the prosthetic valve 100 can include equal numbers of support posts 107 and pairs of actuator posts 122, 124 and the pairs of posts 122, 124 and the support posts 107 can be arranged in an alternating order such that each strut 112 is positioned between one of the pairs of posts 122, 124 and one of the support posts 107 (i.e., each strut 112 can be coupled on one end to one of the posts 122, 124 and can be coupled on the other end to one of the support posts 107). However, the prosthetic valve 100 can include different numbers of support posts 107 and pairs of posts 122, 124 and/or the pairs of posts 122, 124 and the support posts 107 can be arranged in a non-alternating order, in other examples.

[045] As illustrated in FIG. 2B, the struts 112 can include a first row of struts 113 at or near the inflow end 109 of the prosthetic valve 100, a second row of struts 114 at or near the outflow end 108 of the prosthetic valve 100, and third and respectively, positioned axially between the first and second rows of struts 113, 114. The struts 112 can form and/or define a plurality of cells (i.e., openings) in the frame 102. For example, the strut rows 113, 114, 115, and 116 can at least partially form and/or define a plurality of first cells 117 and a plurality of second cells 118 that extend circumferentially around the frame 102. Specifically, each first cell 117 can be formed by two struts 113a, 113b of the first row of struts 113, two struts 114a, 114b of the second row of struts 114, and two of the support posts 107. Each second cell 118 can be formed by two struts 115a, 115b of the third row of struts 115 and two struts 116a, 116b of the fourth row of struts 116. As illustrated in FIGS. 2A and 2B, each second cell 118 can be disposed within one of the first cells 117 (i.e., the struts 115a- 116b forming the second cells 118 are disposed between the struts forming the first cells 117 (i.e., the struts 113a, 113b and the struts 114a, 114b), closer to an axial midline of the frame 102 than the struts 113a-114b).

[046] As illustrated in FIGS. 2A and 2B, the struts 112 of frame 102 can comprise a curved shape. Each first cell 117 can have an axially-extending hexagonal shape including first and second apices 119 (e.g., an inflow apex 119a and an outflow apex 119b). In examples where the delivery apparatus is releasably connected to the outflow apices 119b (as described below), each inflow apex 119a can be referred to as a “distal apex” and each outflow apex 119b can be referred to as a “proximal apex”. Each second cell 118 can have a diamond shape including first and second apices 120 (e.g., distal apex 120a and proximal apex 120b). In some examples, the frame 102 comprises six first cells 117 extending circumferentially in a row, six second cells 118 extending circumferentially in a row within the six first cells 117, and twelve posts 104. However, in some examples, the frame 102 can comprise a greater or fewer number of first cells 117 and a correspondingly greater or fewer number of second cells 118 and posts 104.

[047] As noted above, some of the posts 104 can be arranged in pairs of first and second posts 122, 124. The posts 122, 124 are aligned with each other along the length of the frame 102 and are axially separated from one another by a gap G (FIG. 2B) (those with actuators 126 can be referred to as actuator posts or actuator struts). Each first post 122 (i.e., the lower post shown in FIGS. 2A and 2B) can extend axially from the inflow end 109 of the prosthetic valve 100 toward the second post 124, and the second post 124 (i.e., the upper post shown in FIGS. 2A and 2B) can extend axially from the outflow en< toward the first post 122. For example, each first post 122 can be connected to and extend from an inflow apex 119a and each second post 124 can be connected to and extend from an outflow apex 119b. Each first post 122 and the second post 124 can include an inner bore configured to receive a portion of an actuator member, such as in the form of a substantially straight threaded rod 126 (or bolt) as shown in the illustrated example. The threaded rod 126 also may be referred to herein as actuator 126, actuator member 126, and/or screw actuator 126. In examples where the delivery apparatus can be releasably connected to the outflow end 108 of the frame 102, the first posts 122 can be referred to as distal posts or distal axial struts and the second posts 124 can be referred to as proximal posts or proximal axial struts.

[048] Each threaded rod 126 extends axially through a corresponding first post 122 and second post 124. Each threaded rod 126 also extends through a bore of a nut 127 captured within a slot or window formed in an end portion 128 of the first post 122. The threaded rod

126 has external threads that engage internal threads of the bore of the nut 127. The inner bore of the second post 124 (through which the threaded rod 126 extends) can have a smooth and/or non-threaded inner surface to allow the threaded rod 126 to slide freely within the bore. Rotation of the threaded rod 126 relative to the nut 127 produces radial expansion and compression of the frame 102, as further described below.

[049] In some examples, the threaded rod 126 can extend past the nut 127 toward the inflow end 109 of the frame 102 into the inner bore of the first post 122. The nut 127 can be held in a fixed position relative to the first post 122 such that the nut 127 does not rotate relative to the first post 122. In this way, whenever the threaded rod 126 is rotated (e.g., by a physician) the threaded rod 126 can rotate relative to both the nut 127 and the first post 122. The engagement of the external threads of the threaded rod 126 and the internal threads of the nut

127 prevent the rod 126 from moving axially relative to the nut 127 and the first post 122 unless the threaded rod 126 is rotated relative to the nut 127. Thus, the threaded rod 126 can be retained or held by the nut 127 and can only be moved relative to the nut 127 and/or the first post 122 by rotating the threaded rod 126 relative to the nut 127 and/or the first post 122. In other examples, in lieu of using the nut 127, at least a portion of the inner bore of the first post 122 can be threaded. For example, the bore along the end portion 128 of the first post 122 can comprise inner threads that engage the external th the threaded rod causes the threaded rod 126 to move axially relative to the first post 122.

[050] When a threaded rod 126 extends through and/or is otherwise coupled to a pair of axially aligned posts 122, 124, the pair of axially aligned posts 122, 124 and the threaded rod 126 can serve as one of the expansion and locking mechanisms 106. In some examples, a threaded rod 126 can extend through each pair of axially aligned posts 122, 124 so that all of the posts 122, 124 (with their corresponding rods 126) serve as expansion and locking mechanisms 106. As just one example, the prosthetic valve 100 can include six pairs of posts 122, 124, and each of the six pairs of posts 122, 124 with their corresponding rods 126 can be configured as one of the expansion and locking mechanisms 106 for a total of six expansion and locking mechanisms 106. In other examples, not all pairs of posts 122, 124 need be expansion and locking mechanisms (i.e., actuators). If a pair of posts 122, 124 is not used as an expansion and locking mechanism, a threaded rod 126 need not extend through the posts 122, 124 of that pair.

[051] The threaded rod 126 can be rotated relative to the nut 127, the first post 122, and the second post 124 to axially foreshorten and/or axially elongate the frame 102, thereby radially expanding and/or radially compressing, respectively, the frame 102 (and therefore the prosthetic valve 100). Specifically, when the threaded rod 126 is rotated relative to the nut 127, the first post 122, and the second post 124, the first and second posts 122, 124 can move axially relative to one another, thereby widening or narrowing the gap G (FIG. 2B) separating the posts 122, 124, and thereby radially compressing or radially expanding the prosthetic valve 100, respectively. Thus, the gap G (FIG. 2B) between the first and second posts 122, 124 narrows as the frame 102 is radially expanded and widens as the frame 102 is radially compressed.

[052] The threaded rod 126 can extend proximally past the proximal end of the second post 124 and can include a head portion 131 at its proximal end that can serve at least two functions. First, the head portion 131 can removably or releasably couple the threaded rod 126 to a respective actuator assembly of a delivery apparatus that can be used to radially expand and/or radially compress the prosthetic valve 100 (e.g., the delivery apparatus 200 of FIG. 3, as described below). Second, the head portion 131 can prevent the second post 124 from moving proximally relative to the threaded rod 126 and can apply a distally directed force to the second post 124, such as when radially expanc

Specifically, the head portion 131 can have a width greater than a diameter of the inner bore of the second post 124 such that the head portion 131 is prevented from moving into the inner bore of the second post 124. Thus, as the threaded rod 126 is threaded farther into the nut 127, the head portion 131 of the threaded rod 126 draws closer to the nut 127 and the first post 122, thereby drawing the second post 124 towards the first post 122, and thereby axially foreshortening and radially expanding the prosthetic valve 100.

[053] The threaded rod 126 also can include a stopper 132 (e.g., in the form of a nut, washer or flange) disposed thereon. The stopper 132 can be disposed on the threaded rod 126 such that it sits within the gap G. Further, the stopper 132 can be integrally formed on or fixedly coupled to the threaded rod 126 such that it does not move relative to the threaded rod 126. Thus, the stopper 132 can remain in a fixed axial position on the threaded rod 126 such that it moves in lockstep with the threaded rod 126.

[054] Rotation of the threaded rod 126 in a first direction (e.g., clockwise) can cause corresponding axial movement of the first and second posts 122, 124 toward one another, thereby decreasing the gap G and radially expanding the frame 102, while rotation of the threaded rod 126 in an opposite second direction causes corresponding axial movement of the first and second posts 122, 124 away from one another, thereby increasing the gap G and radially compressing the frame. When the threaded rod 126 is rotated in the first direction, the head portion 131 of the rod 126 bears against an adjacent surface of the frame (e.g., an outflow apex 119b), while the nut 127 and the first post 122 travel proximally along the threaded rod 126 toward the second post 124, thereby radially expanding the frame. As the frame 102 moves from a compressed configuration to an expanded configuration, the gap G between the first and second posts 122, 124 can narrow.

[055] When the threaded rod 126 is rotated in the second direction, the threaded rod 126 and the stopper 132 move toward the outflow end 108 of the frame until the stopper 132 abuts the inflow end 170 of the second post 124 (as shown in FIGS. 2A and 2B). Upon further rotation of the rod 126 in the second direction, the stopper 132 can apply a proximally directed force to the second post 124 to radially compress the frame 102. Specifically, during crimping/radial compression of the prosthetic valve 100, the threaded rod 126 can be rotated in the second direction (e.g., counterclockwise) causing the stopper 132 to push against (i.e., provide a proximally directed force to) the inflow end 170 causing the second post 124 to move away from the first post 122, and thereby axially elongating and radially compressing the prosthetic valve 100.

[056] Thus, each of the second posts 124 can slide axially relative to a corresponding one of the first posts 122 but can be axially retained and/or restrained between the head portion 131 of a threaded rod 126 and a stopper 132. That is, each second post 124 can be restrained at its proximal end by the head portion 131 of the threaded rod 126 and at its distal end by the stopper 132. In this way, the head portion 131 can apply a distally directed force to the second post 124 to radially expand the prosthetic valve 100 while the stopper 132 can apply a proximally directed force to the second post 124 to radially compress the prosthetic valve 100. As explained above, radially expanding the prosthetic valve 100 axially foreshortens the prosthetic valve 100, causing an inflow end portion 134 and outflow end portion 136 of the prosthetic valve 100 (FIGS. 1A and IB) to move towards one another axially, while radially compressing the prosthetic valve 100 axially elongates the prosthetic valve 100, causing the inflow and outflow end portions 134, 136 to move away from one another axially.

[057] In other examples, the threaded rod 126 can be fixed against axial movement relative to the second post 124 (and the stopper 132 can be omitted) such that rotation of the threaded rod 126 in the first direction produces proximal movement of the nut 127 and radial expansion of the frame 102 and rotation of the threaded rod 126 in the second direction produces distal movement of the nut 127 and radial compression of the frame 102.

[058] As also introduced above, some of the posts 104 can be configured as support posts 107. As shown in FIGS. 2A and 2B, the support posts 107 can extend axially between the inflow and outflow ends 109, 108 of the frame 102 and each can have an inflow end portion 138 and an outflow end portion 139. The outflow end portion 139 of one or more support posts 107 can include a commissure support structure or member 144. The commissure support structure 144 can comprise strut portions defining a commissure opening 146 therein.

[059] The commissure opening 146 (which can also be referred to herein as a “commissure window 146”) can extend radially through a thickness of the support post 107 and can be configured to accept a portion of a valvular structure 150 (e.g., a commissure 152) to couple the valvular structure 150 to the frame 102. For example, each commissure 152 can be mounted to a respective commissure support structure 144 commissure tabs of adjacent leaflets 158 through the commissure opening 146 and suturing the commissure tabs to each other and/or the commissure support structure 144. In some examples, the commissure opening 146 can be fully enclosed by the support post 107 such that a portion of the valvular structure 150 can be slid radially through the commissure opening 146, from an interior to an exterior of the frame 102, during assembly. In the illustrated example, the commissure opening 146 has a substantially rectangular shape that is shaped and sized to receive commissure tabs of two adjacent leaflets therethrough. However, in some examples, the commissure opening can have any of various shapes (e.g., square, oval, square-oval, triangular, L-shaped, T-shaped, C-shaped, etc.).

[060] The commissure openings 146 are spaced apart about the circumference of frame 102 (or angularly spaced apart about frame 102). The spacing may or may not be even. In one example, the commissure openings 146 are axially offset from the outflow end 108 of the frame 102 by an offset distance d (indicated in FIG. 2A). As an example, the offset distance da may be in a range from 2 mm to 6 mm. In general, the offset distance da should be selected such that when the leaflets are attached to the frame 102 via the commissure openings 146, the free edge portions (e.g., outflow edge portions) of the leaflets 158 will not protrude from or past the outflow end 108 of the frame 102.

[061] The frame 102 can comprise any number of support posts 107, any number of which can be configured as commissure support structures 144. For example, the frame 102 can comprise six support posts 107, three of which are configured as commissure support structures 144. However, in some examples, the frame 102 can comprise more or less than six support posts 107 and/or more or less than three commissure support structures 144.

[062] The inflow end portion 138 of each support post 107 can comprise an extension 154 (show as a cantilevered strut in FIGS. 2 A and 2B) that extends toward the inflow end 109 of the frame 102. Each extension 154 can comprise an aperture 156 extending radially through a thickness of the extension 154. In some examples, the extension 154 can extend such that an inflow edge of the extension 154 aligns with or substantially aligns with the inflow end 109 of the frame 102. In use, the extension 154 can prevent or mitigate portions of an outer skirt from extending radially inwardly and thereby prevent or mitigate any obstruction of flow through the frame 102 caused by the outer skirt. The extensions 154 can further serve as supports to which portions of the inner and/or outer skirts ; connecting skirt 125 can be coupled. For example, sutures used to connect the inner and/or outer skirts and/or the leaflets and/or the connecting skirt 125 can be wrapped around the extensions 154 and/or can extend through apertures 156.

[063] As an example, each extension 154 can have an aperture 156 (FIG. 2A) or other features to receive a suture or other attachment material for connecting an adjacent inflow edge portion 160 of a leaflet 158 (FIG. 1A), the outer skirt 103 (in FIG. IB), the connecting skirt 125, and/or an inner skirt. In some examples, the inflow edge portion 160 of each leaflet 158 can be connected to a corresponding extension via a suture 135 (FIG. 1A).

[064] In some examples, the outer skirt 103 can be mounted around the outer surface of frame 102 as shown in FIG. IB and the inflow edge of the outer skirt 103 (lower edge in FIG. IB) can be attached to the connecting skirt 125 and/or the inflow edge portions 160 of the leaflets 158 that have already been secured to frame 102 as well as to the extensions 154 of the frame by sutures 129. The outflow edge of the outer skirt 103 (the upper edge in FIG. IB) can be attached to selected struts with stitches 137. In implementations where the prosthetic valve includes an inner skirt, the inflow edge of the inner skirt can be secured to the inflow edge portions 160 before securing the cusp edge portions to the frame so that the inner skirt will be between the leaflets and the inner surface of the frame. After the inner skirt and leaflets are secured in place, then the outer skirt can be mounted around the frame as described above.

[065] The frame 102 can be a unitary and/or fastener-free frame that can be constructed from a single piece of material (e.g., Nitinol, stainless steel or a cobalt-chromium alloy), such as in the form of a tube. The plurality of cells can be formed by removing portions (e.g., via laser cutting) of the single piece of material. The threaded rods 126 can be separately formed and then be inserted through the bores in the second (proximal) posts 124 and threaded into the threaded nuts 127.

[066] In some examples, the frame 102 can be formed from a plastically-expandable material, such as stainless steel or a cobalt-chromium alloy. When the frame is formed from a plastically-expandable material, the prosthetic valve 100 can be placed in a radially compressed state along the distal end portion of a delivery apparatus for insertion into a patient’s body. When at the desired implantation site, the prosthetic valve 100) can be radially expanded from the radially compressed state to a radially expanded state via actuation of actuation assemblies of the delivery apparatus (as further described below), which rotate the rods 126 to produce expansion of the frame 102. During delivery to the implantation site, the prosthetic valve 100 can be placed inside of a delivery capsule (sheath) to protect against the prosthetic valve contacting the patient’s vasculature, such as when the prosthetic valve is advanced through a femoral artery. The capsule can also retain the prosthetic valve in a compressed state having a slightly smaller diameter and crimp profile than may be otherwise possible without a capsule by preventing any recoil (expansion) of the frame once it is crimped onto the delivery apparatus.

[067] In other examples, the frame 102 can be formed from a self-expandable material (e.g., Nitinol). When the frame 102 is formed from a self-expandable material, the prosthetic valve can be radially compressed and placed inside the capsule of the delivery apparatus to maintain the prosthetic valve in the radially compressed state while it is being delivered to the implantation site. When at the desired implantation site, the prosthetic valve is deployed or released from the capsule. In some examples, the frame (and therefore the prosthetic valve) can partially self-expand from the radially compressed state to a partially radially expanded state. The frame 102 (and therefore the prosthetic valve 100) can be further radially expanded from the partially expanded state to a further radially expanded state via actuation of actuation assemblies of the delivery apparatus (as further described below), which rotate the rods 126 to produce expansion of the frame.

[068] As introduced above, the threaded rods 126 can removably couple the prosthetic valve 100 to actuator assemblies of a delivery apparatus. Referring to FIG. 3, it illustrates an exemplary delivery apparatus 200 for delivering a prosthetic device or valve 202 (e.g., prosthetic valve 100) to a desired implantation location. The prosthetic valve 202 can be releasably coupled to the delivery apparatus 200. It should be understood that the delivery apparatus 200 and other delivery apparatuses disclosed herein can be used to implant prosthetic devices other than prosthetic valves, such as stents or grafts.

[069] The delivery apparatus 200 in the illustrated example generally includes a handle 204, a first elongated shaft 206 (which comprises an outer shaft in the illustrated example) extending distally from the handle 204, at least one actuator assembly 208 extending distally through the first shaft 206, a second elongated shaft 209 (v the illustrated example) extending through the first shaft 206, and a nosecone 210 coupled to a distal end portion of the second shaft 209. The second shaft 209 and the nosecone 210 can define a guidewire lumen for advancing the delivery apparatus through a patient’s vasculature over a guidewire. The at least one actuator assembly 208 can be configured to radially expand and/or radially collapse the prosthetic valve 202 when actuated, such as by one or more knobs 211, 212, 214 included on the handle 204 of the delivery apparatus 200.

[070] Though the illustrated example shows two actuator assemblies 208 for purposes of illustration, it should be understood that one actuator assembly 208 can be provided for each actuator (e.g., actuator or threaded rod 126) on the prosthetic valve. For example, three actuator assemblies 208 can be provided for a prosthetic valve having three actuators. In some examples, a greater or fewer number of actuator assemblies can be present.

[071] In some examples, a distal end portion 216 of the shaft 206 can be sized to house the prosthetic valve in its radially compressed, delivery state during delivery of the prosthetic valve through the patient’s vasculature. In this manner, the distal end portion 216 functions as a deliver}' sheath or capsule for the prosthetic valve during delivery,

[072] The actuator assemblies 208 can be releasably coupled to the prosthetic valve 202. For example, in the illustrated example, each actuator assembly 208 can be coupled to a respective actuator (e.g., threaded rod 126) of the prosthetic valve 202. Each actuator assembly 208 can comprise a support tube and an actuator member. When actuated, the actuator assembly can transmit pushing and/or pulling forces to portions of the prosthetic valve to radially expand and collapse the prosthetic valve as previously described. The actuator assemblies 208 can be at least partially disposed radially within, and extend axially through, one or more lumens of the first shaft 206. For example, the actuator assemblies 208 can extend through a central lumen of the shaft 206 or through separate respective lumens formed in the shaft 206.

[073] The handle 204 of the delivery apparatus 200 can include one or more control mechanisms (e.g., knobs or other actuating mechanisms) for controlling different components of the delivery apparatus 200 in order to expand and/or deploy the prosthetic valve 202. For example, in the illustrated example the handle 204 comprii

211, 212, and 214, respectively.

[074] The first knob 211 can be a rotatable knob configured to produce axial movement of the first shaft 206 relative to the prosthetic valve 202 in the distal and/or proximal directions in order to deploy the prosthetic valve from the delivery sheath 216 once the prosthetic valve has been advanced to a location at or adjacent the desired implantation location with the patient’s body. For example, rotation of the first knob 211 in a first direction (e.g., clockwise) can retract the sheath 216 proximally relative to the prosthetic valve 202 and rotation of the first knob 211 in a second direction (e.g., counter-clockwise) can advance the sheath 216 distally. In some examples, the first knob 211 can be actuated by sliding or moving the first knob 211 axially, such as pulling and/or pushing the knob. In some examples, actuation of the first knob 211 (rotation or sliding movement of the first knob 211) can produce axial movement of the actuator assemblies 208 (and therefore the prosthetic valve 202) relative to the delivery sheath 216 to advance the prosthetic valve distally from the sheath 216.

[075] The second knob 212 can be a rotatable knob configured to produce radial expansion and/or compression of the prosthetic valve 202. For example, rotation of the second knob 212 can rotate the threaded rods of the prosthetic valve 202 via the actuator assemblies 208. Rotation of the second knob 212 in a first direction (e.g., clockwise) can radially expand the prosthetic valve 202 and rotation of the second knob 212 in a second direction (e.g., counterclockwise) can radially collapse the prosthetic valve 202. In some examples, the second knob 212 can be actuated by sliding or moving the second knob 212 axially, such as pulling and/or pushing the knob.

[076] The third knob 214 can be a rotatable knob operatively connected to a proximal end portion of each actuator assembly 208. The third knob 214 can be configured to retract an outer sleeve or support tube of each actuator assembly 208 to disconnect the actuator assemblies 208 from the proximal portions of the actuators of the prosthetic valve (e.g., threaded rod). Once the actuator assemblies 208 are uncoupled from the prosthetic valve 202, the delivery apparatus 200 can be removed from the patient, leaving just the prosthetic valve 202 in the patient. [077] Referring to FIGS. 4-5, they illustrate how each of prosthetic device 100 can be removably coupled to an exemplary actuator assembly 300 (e.g., actuator assemblies 208) of a delivery apparatus (e.g., delivery apparatus 200). Specifically, FIG. 5 illustrates how one of the threaded rods 126 can be coupled to an actuator assembly 300, while FIG. 4 illustrates how the threaded rod 126 can be detached from the actuator assembly 300.

[078] As introduced above, an actuator assembly 300 can be coupled to the head portion 131 of each threaded rod 126. The head portion 131 can be included at a proximal end portion 180 of the threaded rod 126 and can extend proximally past a proximal end of the second post 124 (FIG. 2A). The head portion 131 can comprise first and second protrusions 182 defining a channel or slot 184 between them, and one or more shoulders 186. As discussed above, the head portion 131 can have a width greater than a diameter of the inner bore of the second post 124 such that the head portion 131 is prevented from moving into the inner bore of the second post 124 and such that the head portion 131 abuts the outflow end 108 of the frame 102. In particular, the head portion 131 can abut an outflow apex 119b of the frame 102. The head portion 131 can be used to apply a distally-directed force to the second post 124, for example, during radial expansion of the frame 102.

[079] Each actuator assembly 300 can comprise a first actuation member configured as a support tube or outer sleeve 302 and a second actuation member configured as a driver 304. The driver 304 can extend through the outer sleeve 302. The outer sleeve 302 is shown transparently in FIGS. 4-5 for purposes of illustration. The distal end portions of the outer sleeve 302 and driver 304 can be configured to engage or abut the proximal end of the threaded rod 126 (e.g., the head portion 131) and/or the frame 102 (e.g., the apex 119b). The proximal portions of the outer sleeve 302 and driver 304 can be operatively coupled to the handle of a delivery apparatus (e.g., handle 204). The delivery apparatus in this example can include the same features described previously for delivery apparatus 200. In some examples, the proximal end portions of each driver 304 can be operatively connected to the knob 212 such that rotation of the knob 212 (clockwise or counterclockwise) causes corresponding rotation of the drivers 304. The proximal end portions of each outer sleeve 302 can be operatively connected to the knob 214 such that rotation of the knob 214 (clockwise or counterclockwise) causes corresponding axial movement of the sleeves 302 (proximally or distally) relative to the drivers 304. In som electric motors for actuating these components.

[080] The distal end portion of the driver 304 can comprise a central protrusion 306 configured to extend into the slot 184 of the threaded rod 126, and one or more flexible elongated elements or arms 308 including protrusions or teeth 310 configured to be releasably coupled to the shoulders 186 of the threaded rod 126. The protrusions 310 can extend radially inwardly toward a longitudinal axis of the second actuation member 304. As shown in FIGS. 4-5, the elongated elements 308 can be configured to be biased radially outward to an expanded state, for example, by shape setting the elements 308.

[081] As shown in FIG. 5, to couple the actuator assembly 300 to the threaded rod 126, the driver 304 can be positioned such that the central protrusion 306 is disposed within the slot 184 (FIG. 4) and such that the protrusions 310 of the elongated elements 308 are positioned distally to the shoulders 186. As the outer sleeve 302 is advanced (e.g., distally) over the driver 304, the sleeve 302 compresses the elongated elements 308 so that they abut and/or snap over the shoulders 186, thereby coupling the actuator assembly 300 to the threaded rod 126. Thus, the outer sleeve 302 effectively squeezes and locks the elongated elements 308 and the protrusions 310 of the driver 304 into engagement with (i.e., over) the shoulders 186 of the threaded rod 126, thereby coupling the driver 304 to the threaded rod 126.

[082] Because the central protrusion 306 of the driver 304 extends into the slot 184 of the threaded rod 126 when the driver 304 and the threaded rod 126 are coupled, the driver 304 and the threaded rod 126 can be rotationally locked such that they co-rotate. So coupled, the driver 304 can be rotated (e.g., using knob 212 of the handle of the delivery apparatus 200) to cause corresponding rotation of the threaded rod 126 to radially expand or radially compress the prosthetic device. The central protrusion 306 can be configured (e.g., sized and shaped) such that it is advantageously spaced apart from the inner walls of the outer sleeve 302, such that the central protrusion 306 does not frictionally contact the outer sleeve 302 during rotation. Though in the illustrated example the central protrusion 306 has a substantially rectangular shape in cross-section, in some examples, the protrusion 306 can have any of various shapes, for example, square, triangular, oval, etc. The slot 184 can be correspondingly shaped to receive the protrusion 306. [083] The outer sleeve 302 can be advanced distally relat elongated elements 308, until the outer sleeve 302 engages the frame 102 (e.g., a second post 124 of the frame 102). The distal end portion of the outer sleeve 302 also can comprise first and second support extensions 312 defining gaps or notches 314 between the extensions 312. The support extensions 312 can be oriented such that, when the actuator assembly 300 is coupled to a respective threaded rod 126, the support extensions 312 extend partially over an adjacent end portion (e.g., the upper end portion) of one of the second posts 124 on opposite sides of the post 124. The engagement of the support extensions 312 with the frame 102 in this manner can counter-act rotational forces applied to the frame 102 by the rods 126 during expansion of the frame 102. In the absence of a counter-force acting against these rotational forces, the frame can tend to “jerk” or rock in the direction of rotation of the rods when they are actuated to expand the frame. The illustrated configuration is advantageous in that outer sleeves, when engaging the proximal posts 124 of the frame 102, can prevent or mitigate such jerking or rocking motion of the frame 102 when the frame 102 is radially expanded.

[084] To decouple the actuator assembly 300 from the prosthetic device 100, the sleeve 302 can be withdrawn proximally relative to the driver 304 until the sleeve 302 no longer covers the elongated elements 308 of the driver 304. As described above, the sleeve 302 can be used to hold the elongated elements 308 against the shoulders 186 of the threaded rod 126 since the elongated elements 308 can be naturally biased to a radial outward position where the elongated elements 308 do not engage the shoulders 186 of the threaded rod 126. Thus, when the sleeve 302 is withdrawn such that it no longer covers/constrains the elongated elements 308, the elongated elements 308 can naturally and/or passively deflect away from, and thereby release from, the shoulders 186 of the threaded rod 126, thereby decoupling the driver 304 from the threaded rod 126.

[085] The sleeve 302 can be advanced (moved distally) and/or retracted (moved proximally) relative to the driver 304 via a control mechanism (e.g., knob 214) on the handle 204 of the delivery apparatus 200, by an electric motor, and/or by another suitable actuation mechanism. For example, the physician can turn the knob 214 in a first direction to apply a distally directed force to the sleeve 302 and can turn the knob 214 in an opposite second direction to apply a proximally directed force to the sleeve 302. Thus, when the sleeve 302 does not abut the prosthetic device and the physician rotates the knob 214 in the first direction, the sleeve 302 can move distally relative to the driver 304, thereby at driver 304. When the sleeve 302 does abut the prosthetic device, the physician can rotate the knob 214 in the first direction to push the entire prosthetic device distally via the sleeve 302. Further, when the physician rotates the knob 214 in the second direction the sleeve 302 can move proximally relative to the driver 304, thereby withdrawing/retracting the sleeve 302 from the driver 304.

Example 2:. Delivery. Technigues.

[086] For implanting a prosthetic valve within the native aortic valve via a transfemoral delivery approach, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus. The prosthetic valve and the distal end portion of the deliver/ apparatus are inserted into a femoral artery and are advanced into and through the descending aorta, around the aortic arch, and through the ascending aorta. The prosthetic valve is positioned within the native aortic valve and radially expanded (e.g., by inflating a balloon, actuating one or more actuators of the delivery apparatus, or deploying the prosthetic valve from a sheath to allow the prosthetic valve to self- expand). Alternatively, a prosthetic valve can be implanted within the native aortic valve in a transapical procedure, whereby the prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart and the prosthetic valve is positioned within the native aortic valve. Alternatively, in a transaortic procedure, a prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the aorta through a surgical incision in the ascending aorta, such as through a partial J- stemotomy or right parasternal mini-thoracotomy, and then advanced through the ascending aorta toward the native aortic valve.

[087] For implanting a prosthetic valve within the native mitral valve via a transseptal delivery approach, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus. The prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral vein and are advanced into and through the inferior vena cava, into the right atrium, across the atrial septum (through a puncture made in the atrial septum), into the left atrium, and toward the native mitral valve. Alternatively, a prosthetic valve can be implanted within the native mitral valve in a transapical procedure, whereby the prosthetic valve (on the distal end portion of the delivery apparatus) is irilroduced into the left ventricle through a surgical openin heart and the prosthetic valve is positioned within the native mitral valve.

[088] For implanting a prosthetic valve within the native tricuspid valve, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus. The prosthetic valve and tire distal end portion of the delivery apparatus are inserted into a femoral vein and are advanced into and through the inferior vena cava, and into the right atrium, and the prosthetic valve is positioned within the native tricuspid valve. A similar approach can be used for implanting the prosthetic valve within the native pulmonary valve or the pulmonary artery, except that the prosthetic valve is advanced through the native tricuspid valve into the right ventricle and toward the pulmonary valve/pulmonary artery.

[089] Another delivery approach is a transalrial approach whereby a prosthetic valve (on the distal end portion of the delivery apparatus) is inserted through an incision in the chest and an incision made through an atrial wall (of the right or left atrium) for accessing any of the native heart valves. Atrial delivery can also be made intravascularly, such as from a pulmonary vein. Still another delivery approach is a transventricular approach whereby a prosthetic valve (on the distal end portion of the delivery apparatus) is inserted through an incision in the chest and an incision made through the wall of the right ventricle (typically at or near the base of the heart) for implanting the prosthetic valve within the native tricuspid valve, the native pulmonary valve, or the pulmonary artery.

[090] In all delivery approaches, the delivery apparatus can be advanced over a guidewire previously inserted into a patient’s vasculature. Moreover, the disclosed delivery approaches are not intended to be limited. Any of the prosthetic valves disclosed herein can be implanted using any of various delivery procedures and delivery devices known in the art.

Example 3: Mechanically Expandable Prosthetic Valve with Enlarged Strut Window

[091] As stated previously, the prosthetic heart valve examples described herein can be compressible and expandable between a radially compressed or collapsed state, and a radially expanded state. The prosthetic valve examples described herein can be designed to operate within a range of diameters, referred to hereinafter as the “working diameter range” of the prosthetic heart valve. Within at least the working diameter range, the leaflets coapt to regulate blood flow through the prosthetic valve. For exar working diameter range of the prosthetic valves described herein can be 25 mm to 32 mm, such as 27 mm to 30.5mm. In some examples, the frame can have a “natural diameter” that corresponds, for example, to the diameter of the tube from which the frame is cut. The natural diameter can fall within the working diameter range of the prosthetic valve.

[092] To facilitate percutaneous delivery, the prosthetic valve can be crimped to a delivery diameter (also referred to as a crimped state) that is significantly less than the working diameter range, such as 10 mm or less, 8 mm or less, 7 mm or less, etc. In some examples, the prosthetic valves described herein can be crimped to a delivery diameter of 7 mm on the end of a delivery apparatus for insertion into a patient. The actuator mechanisms (also referred to as expansion and locking mechanisms) described herein can be operable to expand and collapse the frame within at least a portion of the working diameter range. The actuator mechanisms can also be operable to expand and collapse the frame at least part of the way between the working diameter range and the delivery diameter. In some examples, the frame can also be expanded beyond the diameter achievable using the actuator mechanisms. For example, in some examples the actuator mechanisms can be operable to expand the prosthetic heart valve to the natural diameter of the frame, and a balloon or other expansion device can be used to expand the frame further within the working diameter range, or beyond the working diameter range. Expanding the prosthetic heart valve beyond the natural diameter of the frame is referred to herein as “over-expanding” and “over-sizing” the prosthetic valve, and can be done in valve-in-valve procedures in which a second prosthetic heart valve is expanded within a first prosthetic heart valve.

[093] For example, in some examples the actuator mechanisms can be operable to collapse the frame from the working diameter range to an intermediate diameter between the working diameter range and the delivery diameter. In some examples, the intermediate diameter can be 12 mm to 16 mm, such as 14 mm. A crimper device can then be used to further compress the prosthetic heart valve from the intermediate diameter to the delivery diameter (e.g., for insertion into a delivery sheath). FIG. 6 schematically illustrates the forces acting on a representative actuator mechanism 106 as the prosthetic heart valve is crimped. As the posts 122 and 124 move axially apart, the restoring force of the struts 112 can place the threaded rod 126 in compression, as indicated by force F. The force F can include an axial component F_y and a radial component F_r. In some examples the fram< its diameter decreases, wherein the diameter of a midsection of the frame between the inflow end and the outflow end is larger than the diameter of the inflow end and the diameter of the outflow end. This can result in, and/or increase the magnitude of, the radial force component F_r on the threaded rod.

[094] Additionally, the length of the rod 126 between the posts 122 and 124 can increase as the posts 122 and 124 move apart. Thus, as the frame nears the intermediate diameter, the length of the rod 126 located between the posts 122 and 124 can be relatively large. Because the portion of the threaded rod 126 between the posts 122 and 124 is unsupported in the radial direction, it can be advantageous to reduce the force F acting on the threaded rod, and thereby the radial force component F_r, to avoid buckling of the threaded rod during valve crimping.

[095] Accordingly, one exemplary solution comprises an opening, slot, etc., referred to hereinafter as a window, formed in one of the posts, such as the post 122, that has a greater axial dimension than a force transmission member positioned in the window, such as the threaded nut described above. The nut can then travel axially within the window as the prosthetic valve moves between the expanded state and the crimped state and vice versa to limit the forces on the threaded rod. In some examples, the nut and threaded rod can move within the window when the threaded rod and/or the associated actuator mechanism are in a locked state (e.g., prevented from rotating).

[096] For example, FIG. 6 illustrates an exemplary post 122 defining a window 190. As indicated in FIGS. 7 and 8, the window 190 can include a proximal end wall or surface 193, a distal end wall or surface 194, and first and second side walls or surfaces 195 and 196. In some examples, the side walls 195 and 196 can be parallel or substantially parallel to the longitudinal axis of the prosthetic valve. A force transmission member configured as a threaded nut 192 (also referred to as a nut) is shown disposed around the threaded rod 126 and received in the window 190. The window 190 can have an axial dimension Li that is greater than an axial dimension (e.g., a thickness) L2 of the nut 192. Thus, the window 190 can be sized to permit the nut 192 to move (e.g., travel, slide) within the window 190 between a first axial position (FIGS. 6 and 7) and a second axial position (FIG. 8). In the orientation shown in the figures, the first axial position is a proximal position and the second axial position is a distal position, and this nomenclature is should be understood that this may be reversed depending upon, for example, the particular native heart valve in which the prosthetic heart valve is deployed and/or the structure of the delivery apparatus. In some examples, the nut 192 and the threaded rod 126 can move together within the window 190. Stated differently, the location of the nut 192 on the threaded rod 126 can be constant as the nut and rod move longitudinally within the window 190.

[097] In the example of FIG. 6, the window 190 can be defined in a portion 123 of the post 122 that has a greater thickness or diameter relative to the remainder of the post 122. The window 190 can also be offset along the negative y-axis (e.g., distally) from the proximal end 141 of the post 122. This can reduce the length of the unsupported (e.g., radially unsupported) portion of the rod when the prosthetic heart valve is in the compressed state.

[098] The nut 192 can move between various positions within the window 190 depending on the diameter of the prosthetic heart valve, and/or whether the prosthetic heart valve is moving between the crimped state and the expanded state or vice versa. For example, when the prosthetic heart valve is at its natural diameter (e.g., 27 mm in some examples), the nut 192 can be at a proximal position in the window 190 illustrated in FIGS. 6 and 7, wherein the nut is adjacent or contacting the proximal surface 193. When the threaded rod 126 is rotated to expand or collapse the frame, the nut 192 can move between the proximal position (FIGS.

6 and 7) and the distal position (FIG. 8) as appropriate to apply force to the post 122 and/or to relieve tension or compression on the threaded rod 126 as discussed below.

[099] For example, when collapsing the prosthetic heart valve from the working diameter range to the intermediate diameter (e.g., from a natural diameter of 27 mm to an intermediate diameter of 14 mm), the nut 192 can be in the distal position as shown in FIG. 8. In some examples, the nut 192 can contact the distal surface 194 of the window 190 in the distal position. By rotating the threaded rod 126 in the second direction (e.g., counterclockwise), the nut 192 can travel along the threaded rod 126 longitudinally in the direction of the negative y-axis in FIG. 6 (e.g., distally) relative to threaded rod 126, the post 122, and the post 124 until the nut contacts the distal surface 194 of the window. Continued rotation of the threaded rod can increase the longitudinal distance between the nut 192 and the stopper 132. Thus, the threaded rod 126 can apply force to the pos post 122 at the nut 192, forcing the posts 122 and 124 apart and collapsing the frame.

[0100] When the prosthetic heart valve reaches a selected intermediate diameter (e.g., 12 mm to 16 mm, such as 14 mm), the threaded rods 126 can be locked in position. The prosthetic heart valve can then be placed in a crimping device to further compress or “crimp” the frame to a selected diameter for delivery, such as any of the delivery diameters given above. In some examples, the crimping device can compress the prosthetic valve to a delivery diameter of 7 mm. During compression to the delivery diameter, the nut 192 (and the threaded rod 126) can slide proximally (e.g., along the positive y-axis) within the window 190 (e.g., as the post 122 moves distally along the negative y-axis relative to the threaded rod and the nut as the frame cells 117 and 118 are collapsed). In some examples, the nut 192 can move to the proximal position shown in FIGS. 6 and 7 during crimping. The distance between the nut 192 and the head portion 131 of the threaded rod 126 can remain constant during crimping. Relative motion of the nut 192 and the post 122 in this manner can advantageously relieve stress on the threaded rod 126 because the nut is not constrained by the proximal surface 193 of the window. In some examples, the nut 192 can contact the proximal surface 193 of the window 190 in the proximal position.

[0101] When the prosthetic heart valve expands from the delivery diameter to, for example, the intermediate diameter (e.g., when the prosthetic heart valve is unsheathed, such as by advancing it out of a delivery sheath), the nut 192 can return to the distal position in the window 190 (FIG. 8). The nut 192 can remain in the distal position as the prosthetic heart valve is expanded to the working diameter range (e.g., by rotating the threaded rods 126 as described above).

[0102] If over-expansion is indicated (e.g., expansion beyond the prosthetic heart valve’s natural diameter, such as during a valve-in- valve procedure), the threaded rod 126 can be locked, and a balloon or other expansion device can be positioned within the prosthetic heart valve and inflated to further expand the frame. During over-expansion of the prosthetic valve, the nut 192 can move to the proximal position in the window 190 (FIGS. 6 and 7). In some examples, the balloon or other expansion mechanism can expand the frame, pushing the posts 122 and 124 closer together such that the nut 192 is between the proximal and distal positions. During over-expansion of the frame with a balh

192 and the head portion 131 of the threaded rod 126 can be constant.

[0103] In some examples, if the nut 192 moves distally out of the proximal position during over-expansion of the prosthetic heart valve, the threaded rod 126 can be turned to advance the nut 192 proximally (e.g., along the positive y-axis in FIG. 6 toward the stopper 132) back to the proximal position in the window 190 such that when the balloon is deflated the nut 192 contacts the proximal surface 193 of the window 190. The nut 192 and the stopper 132 can thereby maintain the prosthetic valve at a selected diameter in the over-expanded state.

[0104] In some examples, the threaded rod 126 can be in tension when the prosthetic heart valve is over-expanded. In some examples, the prosthetic heart valve can be expanded beyond the frame’s natural diameter by rotating the threaded rod 126 to advance the nut 192 proximally without the aid of an expansion device.

[0105] The window 190 can have any selected length depending upon factors such as the size of the frame, the delivery diameter, the working range of the prosthetic heart valve, the thickness of the nut 192, etc. In some examples, the length Li of the window 190 can be 0.5 mm to 4 mm, such as 1 mm to 4 mm, 1 mm to 3.5 mm, 1 mm to 3 mm, 1 mm to 2.5 mm, 1.5 mm to 4 mm, 1.5 mm to 3.5 mm, 1.5 mm to 3 mm, 1.5 mm to 2.5 mm, 1.5 mm to 2.2 mm, 1.5 mm to 2 mm, etc., as measured along the longitudinal axis of the frame. In some examples, the length Li of the window 190 can be 1.5 mm to 2.2 mm.

[0106] In some examples, the thickness L2 of the nut 192 can be 0.1 mm to 2 mm, such as 0.1 mm to 1.5 mm, 0.1 mm to 1 mm, 0.1 mm to 0.9 mm, 0.5 mm to 2 mm, 0.5 mm to 1.5 mm, 0.5 mm to 1 mm, 0.5 mm to 0.9 mm, etc., as measured along the longitudinal axis of the frame. In some examples, the thickness L2 of the nut 192 can be 0.5 mm to 0.9 mm.

[0107] In some examples, a ratio of the thickness L2 of the nut to the length Li of the window (e.g., — Li ) can be 0.1 to 0.8, such as 0.1 to 0.67, 0.1 to 0.5, 0.1 to 0.33, 0.1 to 0.25, 0.1 to 0.167,

0.1 to 0.143, 0.125 to 0.8, 0.125 to 0.67, 0.125 to 0.5, 0.125 to 0.33, 0.125 to 0.25, 0.125 to 0.167, 0.125 to 0.143, 0.167 to 0.8, 0.167 to 0.67, 0.167 to 0..5, 0.167 to 0.0.33, 0.167 to 0.25, 0.8 or less, 0.67 or less, 0.5 or less, 0.33 or less, 0.25 or less, 0.167 or less, 0.143 or less, 0.125 or less, etc. [0108] In some examples, the length of the threaded rod E

10 mm to 15 mm, 10 mm to 12 mm, 8 mm to 12 mm, etc. In some examples, the length of the threaded rod can be 12 mm. In some examples, the major diameter of the threaded rod 126 can be 0.35 mm to 0.75 mm, such as 0.35 mm to 0.7 mm, 0.35 mm to 0.6 mm, 0.35 mm to 0.5 mm, 0.4 mm to 0.75 mm, 0.4 mm to 0.7 mm, 0.4 mm to 0.6 mm, 0.4 mm to 0.5 mm, 0.5 mm to 0.6 mm, etc. In some examples, the major diameter of the threaded rod can be 0.55 mm.

[0109] The frame examples with elongated windows described herein can also be applicable to mechanically expandable prosthetic heart valves with other types of actuator mechanisms besides screw actuators. For example, the prosthetic heart valves described herein can include actuator mechanisms in which the actuator member 126 comprises a ratchet, a ball and detent, recess, or track, or other system for applying force between the post 122 and the post 124 to expand and compress the frame. Such actuator systems can include a force transmission member such as a collar or flange coupled to the actuator member. The actuator member and force transmission member can be movably disposed within a window of a post, such as the window 190 of post 122, and can move within the window to relieve stress on the actuator member as described above.

[0110] Additionally, although the window 190 is shown in the post 122, the window 190 can also be defined in the post 124. The posts 122 and 124 can also each comprise a respective window. A corresponding threaded nut can be disposed in each window around the threaded rod, and the nuts can move within the windows of the posts 122 and 124 as described above. In some examples, the threaded nut 192 can also be configured as an elongated threaded sleeve.

[0111] Example 4: Threaded Nut with Guide Members

[0112] The nut 192 illustrated in FIGS. 6-8 can be mechanically captured within the window 190 of the post 122. Stated differently, the nut 192 can be disposed inside the opening in the post 122 forming the window 190, and motion of the nut 192 within the window 190 can be constrained at least primarily to a single degree of freedom along the y-axis in FIG. 6 between a first or proximal position and a second or distal position. In some examples, the size of the nut 192 relative to the window 190 and/or the material of the nut 192 can be varied to facilitate motion of the nut 192 within the window 190. material having the same or similar hardness to the material of the post 122, or a material having a lower hardness depending upon the particular characteristics sought.

[0113] For example, FIG. 9 illustrates an example of a nut 400. The nut 400 in FIG. 9 has a rectangular body (e.g., square), but it should be understood that the nut can have any specified shape, such as cylindrical, hexagonal, octagonal, etc., depending upon the particular characteristics sought. The nut can define a central opening 402 including threads 404 configured to engage threads of a threaded rod such as described above.

[0114] Referring to FIG. 10, in some examples the width or diameter Wi of the window 190 can be larger than the width or diameter W2 of the nut 192 to facilitate axial movement of the nut within the window. Accordingly, the side walls of the nut 192 can be spaced apart from the respective side walls of the window by gaps 408. This can be particularly advantageous when the post 122 and the nut 192 are made of the same material or materials having a similar hardness because this can reduce friction and binding of the nut within the window. In some examples, the width Wi of the window 190 and the width W2 of the nut 192 can be equal or substantially equal (e.g., within a tolerance of ± 5%, such as ± 2%, ± 1%, etc.). This is illustrated in FIG. 11. It can be advantageous to form the nut with a width that is equal or substantially equal to the width of the window when the nut is made of a material with a lower hardness than the post 122, as further described below. Such a configuration can also further constrain motion of the nut 192 along the x-axis and the z-axis in FIGS. 10 and 11.

[0115] In some examples, the nuts described herein can also include guides that are disposed outside of the window and configured (e.g., shaped and sized) to travel along the exterior of the post as the nut moves within the window. FIGS. 12-14 illustrate example configurations of nuts including flanges. For example, FIG. 12 illustrates the nut 400 including a flange 406 disposed outside the window 190 of a post 122 and coupled to the main body of the nut 400. The flange 406 can have a width W3 that is greater than the width Wi of the window such that the flange 406 constrains motion of the nut along the z-axis (e.g., in the radially inward and outward directions) (FIG. 6). The flange can extend over the post 122 on one side of the window 190, or on both sides of the window. In some examples, the nut 400 can include a flange 406 outside the frame (e.g., contacting the radially outer surface of the post 122) and inside the frame (e.g., contacting the radially inner surface of the post 122). Alternatively, the nut 400 can include a flange positioned on the outside < on the inside of the frame. FIG. 14 is a top plan view of a representative example of a nut 400 including two flanges 406

[0116] The flange 406 can have any specified shape and/or size. In some examples, the flange 406 can be configured as a cover member that at least partially cover the window 190 to prevent the prosthetic valve leaflets, the native leaflets, and/or other structures from extending into the window and potentially becoming damaged or trapped. For example, FIG. 13 illustrates another example of the nut 400 in which the flange 406 has a length Lj that is greater than or equal to the length Li of the window 190. Thus, the flange 406 can at least partially cover the window 190 at any position of the nut 400 within the window. In some examples, the flange can completely cover the window at any position of the nut within the window. The nuts and flanges are shown transparent in FIGS. 12 and 13 for purposes of illustration.

[0117] The nuts described herein can comprise any of a variety of materials. For example, in some examples the nuts can comprise a biocompatible metal material such as cobaltchromium alloys, nickel-titanium alloys such as Nitinol, etc. In some examples, the frame struts such as the post 122 and the nut can comprise a cobalt-chromium alloy. In some examples, cobalt-chromium alloys can have a Rockwell hardness of 30 to 40, such as 33 to 39, depending on a variety of factors including the particular alloy composition, the method of forming the frame (e.g., casting, selective laser melting (SLM), etc.), and the effect of any work hardening, etc. Where the frame and the nut both comprise a metal alloy (e.g., Co-Cr) having a similar hardness, it can be advantageous to undersize the nut relative to the window to reduce the friction and the risk of binding as the nut moves within the window.

[0118] The nuts can also comprise any of various polymeric materials, such as polyetheretherketone (PEEK), polyamide, etc. In some examples, the nuts can comprise a lubricious material. In some examples, the body of the nut can be made from a lubricious material, and/or the nut can comprise a lubricious coating. Exemplary lubricious materials include parylene, diamond-like carbon (DLC), polytetrafluoroethylene (PTFE), etc. In some examples, nuts comprising a polymeric material can have a Shore D hardness of 60 to 90. In some examples, polymeric nuts can be less complex to manufacture than metal nuts. For example, polymeric nuts can be molded (e.g., injection molded), and can be tapped and threaded by drilling with a reduced need for deburring. Pc easily formed with flanges. Additionally, because polymeric nuts have a lower hardness than the metal frame and thereby reduced friction, polymeric nuts can be made with looser tolerance constraints as compared to metal nuts because polymeric nuts will still slide within the strut window even when in contact with the walls (e.g., an interference fit). Polymeric nuts also reduce thread wear on the threaded rods 126, extending the life of the actuator mechanisms.

[0119] Any of the nut examples described herein can be used in combination with any of the frame examples described herein, including frames with elongated windows and those without.

[0120] One or more of the embodiments described herein can provide significant advantages over known mechanically expandable prosthetic heart valves. For example, providing a window in an axial strut member (e.g., a post) of the frame with an axial dimension that is greater than the axial dimension (e.g., a thickness) of the nut can allow the threaded rod and the nut to move axially relative to the frame (e.g., relative to the post 122) to relieve compressive and/or tensile force on the threaded rod during expansion and compression/collapsing of the frame. This can permit the threaded rod to remain straight or substantially straight during expansion and compression of the prosthetic heart valve, reducing the risk of buckling in both the crimped and expanded (e.g., over-expanded) states. Permitting the nut and threaded rod to move axially within the window can relieve stress on the threaded rod even when the threaded rod and/or the associated actuator mechanism is in a locked state, such as during compression of the prosthetic heart valve to the delivery diameter and/or during over-expansion of the prosthetic heart valve.

[0121] The various nut embodiments described herein can also provide a number of advantages. For example, by pairing a metallic threaded rod with a polymeric nut, thread wear on the threaded rod can be reduced due to the difference in hardness between the rod and the nut. This can also reduce the formation of chips or flakes from the thread material, which reduces the risk of the threads binding during operation. This can also reduce the need for deburring and other processing operations during manufacture of the nuts. Polymeric nuts can also provide for looser dimensional tolerances for the nut and for the window in the post, reducing manufacturing costs and improving reliability. Polymeric nuts can also contact the walls of the window during movement without binding. b> herein can also prevent internal components of the prosthetic heart valve such as the leaflets and/or the surrounding native tissue from becoming trapped in the window. Flanges can also improve stability of the nut during the transition between the proximal and distal positions when collapsing and expanding the prosthetic heart valve.

Additional Examples of the Disclosed Technology

[0122] In view of the above described implementations of the disclosed subject matter, this application discloses the additional examples enumerated below. It should be noted that one feature of an example in isolation or more than one feature of the example taken in combination and, optionally, in combination with one or more features of one or more further examples are further examples also falling within the disclosure of this application.

[0123] Example 1. A prosthetic heart valve, comprising: a radially expandable and compressible frame comprising: a pair of axially extending frame members including a first frame member and a second frame member axially spaced from the first frame member, the first frame member defining a window; a threaded nut received in the window of the first frame member; a threaded rod extending through the first and second frame members and through the nut in the window, wherein threads of the rod engage threads of the nut and rotation of the threaded rod in a first direction produces radial expansion of the frame from a radially compressed state to a radially expanded state; and a valvular structure disposed within the frame and configured to regulate blood flow through the frame; wherein the window is sized to permit the nut to travel axially within the window between a first axial position and a second axial position.

[0124] Example 2. The prosthetic heart valve of any example herein, particularly example 1, wherein when the prosthetic heart valve is compressed to a delivery diameter, the nut is in the first axial position.

[0125] Example 3. The prosthetic heart valve of any example herein, particularly example 1 or example 2, wherein when the prosthetic heart valve is at a natural diameter, the threaded nut is in the first axial position. [0126] Example 4. The prosthetic heart valve of any ex examples 1-3, wherein when the prosthetic heart valve is expanded beyond a natural diameter of the prosthetic heart valve, the threaded nut is in the first axial position.

[0127] Example 5. The prosthetic heart valve of any example herein, particularly one of examples 1-4, wherein when the prosthetic heart valve is radially collapsed to a diameter less than a working diameter range of the prosthetic heart valve, the threaded nut is in the second axial position.

[0128] Example 6. The prosthetic heart valve of any example herein, particularly any one of examples 1-5, wherein when the prosthetic heart valve is advanced from a delivery sheath, the threaded nut is in the second axial position.

[0129] Example 7. The prosthetic heart valve of any example herein, particularly any one of examples 1-6, wherein the first axial position is a proximal position; and the second axial position is a distal position.

[0130] Example 8. The prosthetic heart valve of any example herein, particularly any one of examples 1-7, wherein the window comprises a length Li of 1.5 mm to 3 mm measured along a longitudinal axis of the frame.

[0131] Example 9. The prosthetic heart valve of any example herein, particularly example

8, wherein the threaded nut comprises a thickness L2 of 0.5 mm to 1 mm measured along the longitudinal axis of the frame.

[0132] Example 10. The prosthetic heart valve of any example herein, particularly example

9, wherein a ratio — Li is from 0.167 to 0.67.

[0133] Example 11. The prosthetic heart valve of any example herein, particularly any one of examples 1-10, wherein the threaded nut is rectangular.

[0134] Example 12. The prosthetic heart valve of any example herein, particularly any one of examples 1-11, wherein the threaded rod comprises a first material, and the threaded nut comprises a second material that is different from the first material.

[0135] Example 13. The prosthetic heart valve of any example herein, particularly example 12, wherein a hardness of the second material is less than a hardness of the first material. [0136] Example 14. The prosthetic heart valve of any ex of examples 12 or 13, wherein the first material comprises a metal material and the second material comprises a polymeric material.

[0137] Example 15. The prosthetic heart valve of any example herein, particularly example 14, wherein the first material comprises a cobalt-chromium alloy and the second material comprises a plastic material.

[0138] Example 16. The prosthetic heart valve of any example herein, particularly any one of examples 1-15, wherein the threaded nut contacts side walls of the window.

[0139] Example 17. The prosthetic heart valve of any example herein, particularly any one of examples 1-16, wherein side walls of the threaded nut are separated from inner side walls of the window by respective gaps.

[0140] Example 18. The prosthetic heart valve of any example herein, particularly any one of examples 1-17, wherein the threaded nut comprises a guide member disposed outside of the window.

[0141] Example 19. The prosthetic heart valve of any example herein, particularly example 18, wherein the guide member is configured to travel axially along the first frame member as the threaded nut moves relative to the window.

[0142] Example 20. The prosthetic heart valve of any example herein, particularly any one of examples 18 or 19, wherein the guide member is sized and shaped to cover the window.

[0143] Example 21. The prosthetic heart valve of any example herein, particularly example 18, wherein the guide member is a flange.

[0144] Example 22. The prosthetic heart valve of any example herein, particularly any one of examples 18 to 21, wherein the threaded nut comprises a guide member positioned outside the frame.

[0145] Example 23. The prosthetic heart valve of any example herein, particularly any one of examples 18 to 22, wherein the threaded nut comprises a guide member positioned inside the frame. [0146] Example 24. The prosthetic heart valve of any ex of examples 18 to 23, wherein the threaded nut comprises a guide member positioned inside the frame and a guide member positioned outside the frame.

[0147] Example 25. A prosthetic heart valve, comprising: a radially expandable and compressible frame comprising: a pair of axially extending frame members including a first frame member and a second frame member axially spaced from the first frame member, the first frame member defining a window; a threaded nut received in the window of the first frame member; a threaded rod extending through the first and second frame members and through the threaded nut in the window, wherein threads of the threaded rod engage threads of the threaded nut and rotation of the threaded rod in a first direction produces radial expansion of the frame from a radially compressed state to a radially expanded state; and a valvular structure disposed within the frame and configured to regulate blood flow through the frame; wherein the threaded nut comprises a guide member positioned outside the window that covers the window.

[0148] Example 26. The prosthetic heart valve of any example herein, particularly 25, wherein the guide member is configured to travel axially along the first frame member as the threaded nut moves relative to the window.

[0149] Example 27. The prosthetic heart valve of any example herein, particularly example 25 or example 26, wherein the guide member is a flange.

[0150] Example 28. The prosthetic heart valve of any example herein, particularly any one of examples 25 to 27, wherein the guide member is positioned outside the frame.

[0151] Example 29. The prosthetic heart valve of any example herein, particularly any one of examples 25 to 28, wherein the guide member is positioned inside the frame.

[0152] Example 30. The prosthetic heart valve of any example herein, particularly any one of examples 25 to 29, wherein the guide member is a first guide member positioned inside the frame, and the threaded nut further comprises a second guide member positioned outside the frame.

[0153] Example 31. The prosthetic heart valve of any example herein, particularly any one of examples 25 to 30, wherein the window is sized to permit the threaded nut to travel axially within the window between a first axial position and a second axial position. [0154] Example 32. A method, comprising collapsing a radially expanded state to a radially collapsed state by rotating a threaded rod, the threaded rod extending through a first frame member and through a second frame member that is axially spaced from the first frame member and engaging a threaded nut positioned in a window defined in the first frame member, rotation of the threaded rod moving the threaded nut from a proximal position in the window to a distal position in the window.

[0155] Example 33. The method of any example herein, particularly example 32, further comprising compressing the prosthetic heart valve to a delivery diameter such that the threaded nut moves to the proximal position in the window.

[0156] Example 34. The method of any example herein, particularly example 33, further comprising unsheathing the prosthetic heart valve such that the prosthetic heart valve expands from the delivery diameter to an intermediate diameter and the threaded nut moves to the distal position in the window.

[0157] Example 35. The method of any example herein, particularly example 34, further comprising rotating the threaded rod to produce radial expansion of the prosthetic heart valve to a working diameter range of the prosthetic heart valve.

[0158] Example 36. The method of any example herein, particularly example 35, further comprising: positioning an expansion device within the prosthetic heart valve; and expanding the prosthetic heart valve with the expansion device such that the threaded nut moves to the distal position in the window.

[0159] Example 37. A prosthetic heart valve, comprising: a radially expandable and compressible annular frame; a valvular structure disposed within the frame and configured to regulate blood flow through the frame; an actuator assembly coupled to the frame and configured to apply force to the frame to radially expand or compress the frame, the actuator assembly comprising: an axially extending frame member, the frame member defining a window; an actuator member extending through the frame member and through the window; and a force transmission member coupled to the actuator member and received in the window of the frame member; wherein motion of the actuator member in a first direction produces radial expansion of the frame from a radially compressed state to a radially expanded state; and wherein the window of the frame member is sized to permit the force transmission member to travel axially within the window between a firs position.

[0160] In view of the many possible examples to which the principles of the disclosure may be applied, it should be recognized that the illustrated examples are only preferred examples and should not be taken as limiting the scope of the disclosure. Rather, the scope of the disclosure is at least as broad as the following claims and their equivalents. We therefore claim all that comes within the scope and spirit of these claims.

Claims

Claims:

1. A prosthetic heart valve, comprising: a radially expandable and compressible frame comprising: a pair of axially extending frame members including a first frame member and a second frame member axially spaced from the first frame member, the first frame member defining a window; a threaded nut received in the window of the first frame member; a threaded rod extending through the first and second frame members and through the threaded nut in the window, wherein threads of the rod engage threads of the threaded nut and rotation of the threaded rod in a first direction produces radial expansion of the frame from a radially compressed state to a radially expanded state; and a valvular structure disposed within the frame and configured to regulate blood flow through the frame; wherein the window is sized to permit the threaded nut to travel axially within the window between a first axial position and a second axial position.

2. The prosthetic heart valve of claim 1, wherein when the prosthetic heart valve is compressed to a delivery diameter, the threaded nut is in the first axial position.

3. The prosthetic heart valve of claim 1 or claim 2, wherein when the prosthetic heart valve is at a natural diameter, the threaded nut is in the first axial position.

4. The prosthetic heart valve of any one of claims 1-3, wherein when the prosthetic heart valve is expanded beyond a natural diameter of the prosthetic heart valve, the threaded nut is in the first axial position.

5. The prosthetic heart valve of any one of claims 1-4, wherein when the prosthetic heart valve is radially collapsed to a diameter less than a working diameter range of the prosthetic heart valve, the threaded nut is in the second axial position.

6. The prosthetic heart valve of any one of claims 1-5, wherein when the prosthetic heart valve is advanced from a delivery sheath, the threaded nut is in the second axial position.

7. The prosthetic heart valve of any one of claims 1-6, wherein: the first axial position is a proximal position; and the second axial position is a distal position.

8. The prosthetic heart valve of any one of claims 1-7, wherein the window comprises a length Li of 1.5 mm to 3 nmi measured along a longitudinal axis of the frame.

9. The prosthetic heart valve of claim 8, wherein the threaded nut comprises a thickness £2 of 0.5 mm to 1 mm measured along the longitudinal axis of the frame.

10. The prosthetic heart valve of any one of claim 8 or claim 9, wherein a ratio — Li is from 0.167 to 0.67.

11. The prosthetic heart valve of any one of claims 1-10, wherein the threaded nut is rectangular.

12. The prosthetic heart valve of any one of claims 1-11, wherein the threaded rod comprises a first material, and the threaded nut comprises a second material that is different from the first material.

13. The prosthetic heart valve of claim 12, wherein a hardness of the second material is less than a hardness of the first material.

14. The prosthetic heart valve of any one of claims 12 or 13, wherein the first material comprises a metal material and the second material comprises a polymeric material.

15. The prosthetic heart valve of claim 14, wherein the first material comprises a cobalt-chromium alloy and the second material comprises a plastic material.

16. The prosthetic heart valve of any one of claims 1-15, wherein the threaded nut contacts side walls of the window.

17. The prosthetic heart valve of any one of claims 1-16, wherein side walls of the threaded nut are separated from inner side walls of the window by respective gaps.

18. The prosthetic heart valve of any one of claims 1-17, wherein the threaded nut comprises a guide member disposed outside of the window.

19. The prosthetic heart valve of claim 18, wherein the guide member is configured to travel axially along the first frame member as the threaded nut moves relative to the window.

20. The prosthetic heart valve of any one of claims 18 or 19, wherein the guide member is sized and shaped to cover the window.

21. The prosthetic heart valve of any one of claims 18-20, wherein the guide member is a flange.

22. The prosthetic heart valve of any one of claims 18 to 21, wherein the threaded nut comprises a guide member positioned outside the frame.

23. The prosthetic heart valve of any one of claims 18 to 22, wherein the threaded nut comprises a guide member positioned inside the frame.

24. The prosthetic heart valve of any one of claims 18 to 23, wherein the threaded nut comprises a guide member positioned inside the frame and a guide member positioned outside the frame.

25. A prosthetic heart valve, comprising: a radially expandable and compressible frame comprising: a pair of axially extending frame members including a first frame member and a second frame member axially spaced from the first frame member, the first frame member defining a window; a threaded nut received in the window of the first frame member; a threaded rod extending through the first and second frame members and through the threaded nut in the window, wherein threads of the threaded rod engage threads of the threaded nut and rotation of the threaded rod in a first direction produces radial expansion of the frame from a radially compressed state to a radially expanded state; and a valvular structure disposed within the frame and configured to regulate blood flow through the frame; wherein the threaded nut comprises a guide member positioned outside the window that at least partially covers the window.

26. The prosthetic heart valve of claim 25, wherein the guide member is configured to travel axially along the first frame member as the threaded nut moves relative to the window.

27. The prosthetic heart valve of claim 25 or claim 26, wherein the guide member is a flange.

28. The prosthetic heart valve of any one of claims 25 to 27, wherein the guide member is positioned outside the frame.

29. The prosthetic heart valve of any one of claims 25 to 28, wherein the guide member is positioned inside the frame.

30. The prosthetic heart valve of any one of claims 25 to 29, wherein the guide member is a first guide member positioned inside the frame, and the threaded nut further comprises a second guide member positioned outside the frame.

31. The prosthetic heart valve of any one of claims 25 to 30, wherein the window is sized to permit the threaded nut to travel axially within the window between a first axial position and a second axial position.

32. A method, comprising collapsing a prosthetic heart valve from a radially expanded state to a radially collapsed state by rotating a threaded rod, the threaded rod extending through a first frame member and through a second frame member that is axially spaced from the first frame member and engaging a threaded nut positioned in a window defined in the first frame member, rotation of the threaded rod moving the threaded nut from a proximal position in the window to a distal position in the window.

33. The method of claim 32, further comprising compressing the prosthetic heart valve to a delivery diameter such that the threaded nut moves to the proximal position in the window.

34. The method of claim 33, further comprising unsheathing the prosthetic heart valve such that the prosthetic heart valve expands from the delivery diameter to an intermediate diameter and the threaded nut moves to the distal position in the window.

35. The method of claim 34, further comprising rotating the threaded rod to produce radial expansion of the prosthetic heart valve to a working diameter range of the prosthetic heart valve.

36. The method of claim 35, further comprising: positioning an expansion device within the prosthetic heart valve; and expanding the prosthetic heart valve with the expansion device such that the threaded nut moves to the distal position in the window.

37. A prosthetic heart valve, comprising: a radially expandable and compressible annular frame; a valvular structure disposed within the frame and configured to regulate blood flow through the frame; an actuator assembly coupled to the frame and configured to apply force to the frame to radially expand or compress the frame, the actuator assembly comprising: an axially extending frame member, the frame member defining a window; an actuator member extending through the frame member and through the window; and a force transmission member coupled to the actuator member and received in the window of the frame member; wherein motion of the actuator member in a first direction produces radial expansion of the frame from a radially compressed state to a radially expanded state; and wherein the window of the frame member is sized to permit the force transmission member to travel axially within the window between a first axial position and a second axial position.