Actuation mechanism for artificial heart valves

Abstract

The present disclosure is directed to prosthetic heart valves and actuators for prosthetic heart valves. In some embodiments, the actuators can include an internally threaded bore that engages with an externally threaded portion of a frame component, such as a fixation post. In some embodiments, the actuators can include an externally threaded end that engages with an internally threaded bore in a frame component, such as a fixation post.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Patent Application No. 63 / 318,547, filed March 10, 2022, the entire contents of which are incorporated by reference herein. Field

[0002] The present disclosure relates to implantable, expandable prosthetic heart valves and actuation mechanisms for use with expandable prosthetic heart valves. background [Background technology]

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

[0004] These prosthetic heart valves are subject to a variety of technical challenges. It is desirable for these prosthetic heart valves to have a small cross-sectional, or crimped, profile to facilitate delivery of the valve to the desired implantation site. Furthermore, it is desirable for the components of the prosthetic heart valve to be robust and protected from wear and fatigue to support extended periods of use without damage or failure.

[0005] Mechanical actuators for radially expanding transcatheter heart valves may increase the overall crimp profile of the prosthesis and / or increase the complexity and cost of the manufacturing process. Thus, there is a continuing need for new and improved transcatheter prosthetic heart valves having mechanical actuators. Summary of the Invention

[0006] Disclosed herein is a prosthetic heart valve assembly including an actuation bolt that directly engages one or more posts of a prosthetic heart valve frame. The disclosed actuation bolt can include an internally threaded bore and can operably engage with an externally threaded end of a post of the prosthetic heart valve. Alternatively, the disclosed actuation bolt can include an externally threaded end that can operably engage with an internally threaded bore in a post of the prosthetic heart valve. Such an actuation assembly can avoid the need for an actuation nut. This avoids the need for a nut window in the post of the prosthetic heart valve that is operably engaged with the actuation mechanism. In this manner, the actuation assembly disclosed herein allows for the design of a prosthetic heart valve with a narrower crimp profile, which avoids wear from the relative movement of the actuation nut to the post of the prosthetic heart valve.

[0007] The prosthetic heart valve may include a frame and a valve structure coupled to the frame. In addition to these components, the prosthetic heart valve may further include one or more of the components disclosed herein.

[0008] In some embodiments, the prosthetic heart valve can include a sealing member configured to reduce paravalvular leakage.

[0009] In some embodiments, the prosthetic heart valve may include an actuator that includes an internally threaded bore.

[0010] In some embodiments, the internally threaded hole can receive an externally threaded portion of the post.

[0011] In some examples, the prosthetic heart valve may include an actuator that includes an externally threaded portion.

[0012] In some embodiments, the externally threaded portion of the actuator may be received by an internally threaded bore in the post.

[0013] Certain examples relate to a prosthetic valve comprising a radially expandable frame having a plurality of interconnected struts, the frame being radially expandable between a radially compressed state and a radially expanded state, the frame comprising at least one axially oriented first post having an externally threaded portion. The prosthetic heart valve also includes a valve structure disposed within the frame and configured to regulate unidirectional blood flow through the frame, and at least one rotatable actuator operably coupled to the frame. The actuator comprises an internally threaded bore that receives the externally threaded portion of the post, the actuator being rotatable relative to the post in a first rotational direction to generate radial expansion of the frame from the radially compressed state to the radially expanded state.

[0014] Certain examples relate to a prosthetic valve comprising an annular frame having a first end, a second end, a longitudinal axis extending from the first end to the second end, and a plurality of struts forming a plurality of cells between the first end and the second end. The prosthetic valve also includes a valve structure disposed within the frame and configured to regulate unidirectional blood flow through the frame. The prosthetic valve also includes a plurality of vertical posts oriented parallel to the longitudinal axis and an actuation member having a first end and a second end, the first end including an axially oriented internally threaded bore. The internally threaded bore of the actuation member is operably coupled to an externally threaded portion of a first vertical post of the plurality of vertical posts. The actuation member is rotatable in a first rotational direction relative to the first vertical post to radially expand the frame from a radially compressed state to a radially expanded state, and is rotatable in a second rotational direction to radially compress the frame from the radially expanded state to a radially compressed state.

[0015] Certain examples relate to a medical assembly including a prosthetic heart valve having a radially expandable frame, a valve structure disposed within the frame and configured to regulate unidirectional blood flow through the frame, a vertically oriented first post, and at least one actuator operably coupled to the vertically oriented first post. The medical assembly also includes a delivery device removably attached to the actuator. The frame includes a plurality of interconnected struts and is radially expandable between a radially compressed state and a radially expanded state. The vertically oriented first post includes an externally threaded end. The actuator includes an internally threaded end that receives the externally threaded end of the vertically oriented first post, and the actuator is rotatable in a first rotational direction relative to the first post to generate radial expansion of the frame.

[0016] In some embodiments, the prosthetic heart valve comprises one or more of the components listed in Examples 1-36 below.

[0017] The various innovations in this disclosure can be used in combination or separately. This Summary is provided to introduce in a simplified form a selection of various concepts that are further described below in the Detailed Description. This Summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. These and other objects, features, and advantages of the present disclosure will become more apparent from the following Detailed Description, from the claims, and from the accompanying drawings. [Brief description of the drawings]

[0018] [Figure 1A] FIG. 1A is a perspective view of one embodiment of a prosthetic valve including a frame and multiple leaflets attached to the frame. [Figure 1B] FIG. 1B is a perspective view of the prosthetic valve of FIG. 1A having an outer skirt disposed about the frame. [Figure 2A] FIG. 2A is a perspective view of a frame for the prosthetic valve of FIG. 1A. [Figure 2B] FIG. 2B is a front portion of the frame shown in FIG. 2A. [Diagram 3] FIG. 3 is a side view of a delivery device for a prosthetic device, such as a prosthetic valve, according to one embodiment. [Figure 4] FIG. 4 is a perspective view of a portion of the actuator of the prosthetic device of FIGS. 1-2 and an actuator assembly of a delivery device, according to one embodiment. [Diagram 5] FIG. 5 is a perspective view of the actuator and actuator assembly of FIG. 4, with the actuator assembly physically coupled to the actuator. [Figure 6] FIG. 6 is a side view of a portion of an embodiment of a frame and an actuation member operably coupled to a vertical post of the frame. [Figure 7] FIG. 7 is a side view of a portion of an embodiment of a frame and an actuation member operably coupled to a vertical post of the frame, with the frame shown in a radially expanded configuration. [Figure 8] 8 is an enlarged view of a portion of the actuation member and vertical post of the frame of FIG. [Figure 9] 9 is a side view of the frame portion of FIG. 7 shown in a radially compressed configuration. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0019] Detailed Description General Considerations For purposes of this specification, certain aspects, advantages, and novel features of the disclosed examples are described herein. The disclosed methods, devices, and systems should not be construed as limiting in any way. Instead, the disclosure is directed to all novel and non-obvious features and aspects of the various disclosed examples, alone, in various combinations with each other, and in various subcombinations with each other. The methods, devices, and systems are not limited to any particular aspects, features, or combinations thereof, nor do the disclosed examples require that any one or more particular advantages be present or problems be solved.

[0020] Although operations in some disclosed examples are described in a particular sequential order for convenience of presentation, it will be understood that aspects of the description encompass permutations unless a particular order is required by specific language set forth herein. For example, operations described sequentially may in some cases be permuted or performed simultaneously. Moreover, for simplicity, the accompanying drawings may not show various ways in which the disclosed methods may be used in combination with other methods. Additionally, the description sometimes uses terms such as "provide" or "achieve" to describe the disclosed methods. These terms are high-level abstractions of the actual operations that are performed. The actual operations that correspond to these terms may vary depending on the particular implementation and are readily discernible by those skilled in the art.

[0021] 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." Furthermore, the term "coupled" generally means to be physically, mechanically, chemically, magnetically, and / or electrically coupled or connected, and does not exclude the presence of intermediate elements between coupled or associated members, unless specifically stated to the contrary.

[0022] As used herein, the term "proximal" refers to a position, orientation, or portion of a device that is closer to the user and farther away from the implantation site. As used herein, the term "distal" refers to a position, orientation, or portion of a device that is farther away from the user and closer to the implantation site. Thus, for example, proximal movement of a device is movement of the device away from the implantation site toward the user (e.g., outside the patient's body), while distal movement of a device is movement of the device away from the user toward the implantation site (e.g., into the patient's body). The terms "longitudinal" and "axial" refer to axes extending proximally and distally, unless expressly defined otherwise. Introduction to the disclosed technology

[0023] The prosthetic valves disclosed herein can be radially compressible and expandable between a radially compressed state and a radially expanded state. Thus, the prosthetic valve can be crimped onto or held by the implant delivery device in a radially compressed state while being advanced through the patient's vasculature on the delivery device. The prosthetic valve can be expanded to a radially expanded state once the prosthetic valve reaches the implantation site. It will be appreciated that the prosthetic valves disclosed herein can be used with a variety of implant delivery devices and can be implanted via a variety of delivery procedures, examples of which are described in more detail below.

[0024] 1A-2B illustrate an exemplary prosthetic device (e.g., a prosthetic heart valve) that can be advanced through a patient's vasculature, for example, to a native heart valve, by a delivery device, such as the exemplary delivery device illustrated in FIG. 3. The frame of the prosthetic heart valve can include one or more mechanical expansion and locking mechanisms that can be incorporated within the frame, specifically, within the axially extending posts of the frame. The mechanical expansion and / or locking mechanisms can be removably coupled to and / or actuated by the delivery device to radially expand the prosthetic heart valve and lock the prosthetic heart valve in one or more radially expanded states.

[0025] Examples of the disclosed technology 1A-2B show an exemplary prosthetic valve 100, according to one embodiment. Any prosthetic valve disclosed herein is adapted to be implanted in the native aortic valve annulus, but in some embodiments may be adapted to be implanted in other native valve annulus of the heart (pulmonary, mitral, and tricuspid valves). The disclosed prosthetic valves may also be implanted within blood vessels communicating with the heart, including the pulmonary artery (to replace the function of a diseased pulmonary valve), the superior vena cava or the inferior vena cava (to replace the function of a diseased tricuspid valve), or various other veins, arteries, and blood vessels of the patient. The disclosed prosthetic valves may also be implanted within a prosthetic valve previously implanted in a valve-in-valve procedure, which may be a prosthetic surgical valve or a prosthetic transcatheter heart valve.

[0026] In some embodiments, the disclosed prosthetic valves can be implanted within a docking device or anchoring device that is implanted within a native heart valve or blood vessel. For example, in one embodiment, the disclosed prosthetic valves can be implanted within a docking device implanted within the pulmonary artery to replace the function of a diseased pulmonary valve, as disclosed, for example, in U.S. Patent Application Publication No. 2017 / 0231756, which is incorporated herein by reference. In one embodiment, the disclosed prosthetic valves can be implanted within a native mitral valve or within a docking device implanted therein, as disclosed, for example, in International Publication No. WO2020 / 247907, which is incorporated herein by reference. In one embodiment, the disclosed prosthetic valves can be implanted within a docking device implanted within the superior vena cava or inferior vena cava to replace the function of a diseased tricuspid valve, as disclosed, for example, in U.S. Patent Application Publication No. 2019 / 0000615, which is incorporated herein by reference.

[0027] 1A-2B show an embodiment of a prosthetic valve 100 (sometimes referred to herein as a "prosthetic heart valve 100") having a frame 102. FIGS. 2A-2B show the frame 102 alone, while FIGS. 1A-1B show the frame 102 with a valvular structure 150 (which may include leaflets 158, as described further herein) within and attached to the annular frame 102. FIG. 1B also shows an optional skirt assembly comprising an outer skirt 103. Although only one side of the frame 102 is shown in FIG. 2B, it should be understood that the frame 102 forms an annular structure, as shown in FIGS. 1A-2A, with the opposite side being substantially identical to the portion shown in FIG. 1B.

[0028] 1A and 1B, the valve structure 150 is coupled to and supported within the frame 102. The valve structure 150 is configured to regulate blood flow through the prosthetic valve 100 from the inflow end 134 to the outflow end 136. The valve structure 150 may include a leaflet assembly including one or more leaflets 158 made, for example, of a flexible material. The leaflets 158 may be made, in whole or in part, from a biological material, from a biocompatible synthetic material, or from other such materials. Suitable biological materials may include, for example, bovine pericardium (or pericardium from other sources). The leaflets 158 may be secured to one another at their adjacent sides to form commissures 152, each of which may be secured to a respective commissure support structure 144 (also referred to herein as a "commissure support") and / or to other portions of the frame 102, as described in more detail herein.

[0029] 1A and 1B, the valve structure 150 includes three leaflets 158 that may be configured to fold in a tricuspid arrangement. Each leaflet 158 ​​may have an inflow edge 160 (which may also be referred to as a leaflet edge) (FIG. 1A). The inflow edges 160 of the leaflets 158 may define an undulating, curved, scalloped edge that generally circumferentially follows or tracks portions of the struts 112 of the frame 102 when the frame 102 is in a radially expanded configuration. The inflow edges 160 of the leaflets 158 may be referred to as a "scallop line."

[0030] The prosthetic valve 100 may include one or more skirts attached around the frame 102. For example, as shown in FIG. 1B, the prosthetic valve 100 may include an outer skirt 103 attached around the outer surface of the frame 102. The outer skirt 103 may function as a sealing member for the prosthetic valve 100 by sealing against the tissue of the native annulus and helping to reduce paravalvular leakage through the prosthetic valve 100. In some cases, an inner skirt (not shown) may be attached around the inner surface of the frame 102. The inner skirt may function as a sealing member to prevent or reduce paravalvular leakage, secure the leaflets 158 to the frame 102, and / or protect the leaflets 158 from damage caused by contact with the frame 102 during crimping and during the work cycle of the prosthetic valve 100. In some embodiments, the inflow edge 160 of the leaflets 158 may be sutured to the inner skirt, generally along a scallop line. The inner skirt may then be sewn to the adjacent struts 112 of the frame 102. In some embodiments, as shown in FIG. 1A, the leaflets 158 may be sewn directly to the frame 102 or to the reinforcement member 125 (also referred to as a reinforcement skirt, or connecting skirt) in the form of a strip of material (e.g., a fabric strip), which is then sewn to the frame 102 along the scallop line via stitches (e.g., whip stitches) 133.

[0031] The inner and outer skirts, as well as the connecting skirt 125, may be formed completely or partially from any suitable biological material, synthetic material (e.g., any of a variety of polymers), or combinations thereof. In some examples, the skirt may include a fabric having interwoven yarns or fibers, such as in the form of a woven, braided, or knitted fabric. In some examples, the fabric may have a nap or pile of fluff. Exemplary fabrics having a nap or pile of fluff include velour, velvet, corduroy, terry cloth, fleece, and the like. In some examples, the skirt may include a fabric without interwoven yarns or fibers, such as a felt or an electrospun fabric. Exemplary materials that may be used to form such fabrics (with or without interwoven yarns or fibers) include, but are not limited to, polyethylene (PET), ultra-high molecular weight polyethylene (UHMWPE), polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), polyamide, and the like. In some examples, the skirt can include a non-textile or non-fabric material, such as a film made from any of a variety of polymeric materials, such as PTFE, PET, polypropylene, polyamide, polyetheretherketone (PEEK), polyurethane (such as thermoplastic polyurethane (TPU)), etc. In some examples, the skirt can include a sponge material or foam, such as polyurethane foam. In some examples, the skirt can include natural tissue, such as pericardial tissue (e.g., bovine pericardium, porcine pericardium, equine pericardium, or pericardium from other sources).

[0032] Further details regarding the assembly of the leaflet assembly and the assembly of the leaflets and skirt to the frame can be found, for example, in U.S. Provisional Patent Application No. 63 / 209,904, filed June 11, 2021, and No. 63 / 224,534, filed July 22, 2021, which are incorporated by reference herein. Further details of the structure and function of the frame 102 can be found in International Patent Application No. PCT / US2021 / 052745, filed September 30, 2021, which is incorporated by reference herein.

[0033] The frame 102, shown alone and in more detail in Figures 2A and 2B, includes an inflow end 109, an outflow end 108, and a number of axially extending posts 104. The axial direction of the frame 102 is indicated by a longitudinal axis 105 extending from the inflow end 109 to the outflow end 108 (Figures 2A and 2B). Some of the posts 104 may be disposed in axially aligned pairs of first and second struts or posts 122, 124. An actuator 126 (such as a threaded rod or bolt, as shown) may 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 described further herein. One or more of the posts 104 may be configured as support posts 107.

[0034] The frame 102 can be formed from any of a variety of suitable plastically expandable materials (such as, for example, stainless steel) or from self-expanding materials (such as, for example, Nitinol) as known in the art. If constructed from a plastically expandable material, the frame 102 (and thus the valve 100) can be crimped into a radially compressed state on a delivery catheter and then expanded within the patient's body by an inflatable balloon or equivalent expansion mechanism. If constructed from a self-expandable material, the frame 102 (and thus the valve 100) can be crimped into a radially compressed state and constrained in the compressed state by insertion into a sheath or equivalent mechanism of the delivery catheter. After introduction into the body, the valve can be advanced from the delivery sheath, which allows the valve to expand to its functional size.

[0035] Suitable plastically expandable materials that can be used to form the frames disclosed herein (e.g., frame 102) include metal alloys, polymers, or combinations thereof. Exemplary metal alloys can include one or more of nickel, cobalt, chromium, molybdenum, titanium, or other biocompatible metals. In some embodiments, frame 102 can include stainless steel. In some embodiments, frame 102 can include cobalt-chromium. In some embodiments, frame 102 can include nickel-cobalt-chromium. In some embodiments, frame 102 can include nickel-cobalt-chromium. In some embodiments, frame 102 can include a nickel-cobalt-chromium alloy, such as MP35N™ (a trademark of SPS Technologies), which is equivalent to UNS R30035 (certified by ASTM F562-02). MP35N™ / UNS R30035 includes 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum by weight.

[0036] The actuator mechanism 106 (which may be used to radially expand and / or radially compress the prosthetic valve 100) may be incorporated into the frame 102 of the prosthetic valve 100, thereby reducing the crimp profile and / or bulk of the prosthetic valve 100. Incorporating the actuator mechanism 106 (which may also be referred to herein as an "expansion and locking mechanism") into the frame 102 may also simplify the design of the prosthetic valve 100, thereby making the prosthetic valve 100 less costly and / or easier to manufacture. In the illustrated embodiment, an actuator 126 extends through each pair of axially aligned posts 122, 124. In some embodiments, one or more of the pairs of posts 122, 124 may not have a corresponding actuator.

[0037] The posts 104 may be coupled together by a plurality of circumferentially extending link members or struts 112. Each strut 112 extends circumferentially between adjacent posts 104 and connects all of the axially extending posts 104. As an example, the prosthetic valve 100 may include an equal number of support posts 107 and pairs of actuator posts 122, 124, as well as pairs of posts 122, 124, and the support posts 107 may 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 may be coupled at one end to one of the posts 122, 124 and at the other end to one of the support posts 107). However, the prosthetic valve 100 may include a different number of support posts 107 and pairs of posts 122, 124, and / or the pairs of posts 122, 124 and the support posts 107 may be arranged in a non-alternating order in some embodiments.

[0038] 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 a third row of struts 115 and a fourth row of struts 116 each axially disposed between the first row of struts 113 and the second row of struts 114. The struts 112 can form and / or define a plurality of cells (i.e., openings) in the frame 102. For example, the struts 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 may be formed by two columns 113a, 113b of the first row of columns 113, two columns 114a, 114b of the second row of columns 114, and two of the support posts 107. Each second cell 118 may be formed by two columns 115a, 115b of the third row of columns 115, and two columns 116a, 116b of the fourth row of columns 116. As shown in Figures 2A and 2B, each second cell 118 may be located within one of the first cells 117 (i.e., the pillars 115a-116b forming the second cell 118 are closer to the center of the axial line of the frame 102 than the pillars 113a-114b and are located between the pillars forming the first cell 117 (i.e., pillars 113a, 113b and pillars 114a, 114b)).

[0039] As shown in FIGS. 2A and 2B, the struts 112 of the frame 102 may include a curved shape. Each first cell 117 may have an axially extending hexagonal shape including first and second vertices 119 (e.g., inflow vertex 119a and outflow vertex 119b). In embodiments where a delivery device is removably connected to the outflow vertex 119b (as described herein), each inflow vertex 119a may be referred to as a "distal vertex" and each outflow vertex 119b may be referred to as a "proximal vertex". Each second cell 118 may have a diamond shape including first and second vertices 120 (e.g., distal vertex 120a and proximal vertex 120b). In some embodiments, the frame 102 includes 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. In some embodiments, frame 102 may include a greater or lesser number of first cells 117 and a corresponding greater or lesser number of second cells 118 and posts 104 .

[0040] As referred to herein, some of the posts 104 may be arranged in pairs of first and second posts 122, 124. The posts 122, 124 are aligned with one another along the length of the frame 102 and axially spaced apart from one another by a gap G (FIG. 2B) (those with actuators 126 may be referred to as actuator posts, or actuator struts). Each first post 122 (i.e., the lower post shown in FIGS. 2A and 2B) may extend axially from the inflow end 109 of the prosthetic valve 100 toward the second post 124, and each second post 124 (i.e., the upper post shown in FIGS. 2A and 2B) may extend axially from the outflow end 108 of the prosthetic valve 100 toward the first post 122. For example, each first post 122 may be connected to and extend from the inflow apex 119a, and each second post 124 may be connected to and extend from the outflow apex 119b. Each of the first post 122 and second post 124 may include an internal 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 embodiment. The threaded rod 126 may also be referred to herein as the actuator 126, the actuator member 126, and / or the threaded actuator 126. In embodiments in which the delivery device is removably connectable to the outflow end 108 of the frame 102, the first post 122 may be referred to as the distal post or distal axial post, and the second post 124 may be referred to as the proximal post or proximal axial post.

[0041] Each threaded rod 126 extends axially through a corresponding first post 122 and second post 124. Each threaded rod 126 also extends through a hole in a nut 127 captured in a slot or window formed in an end 128 of the first post 122. The threaded rod 126 has external threads that engage with internal threads of the hole in the nut 127. The inner hole of the second post 124 through which the threaded rod 126 extends may have a smooth and / or unthreaded inner surface to allow the threaded rod 126 to slide freely within the hole. Rotation of the threaded rod 126 relative to the nut 127 causes the frame 102 to radially expand and compress, as described further herein.

[0042] In some embodiments, the threaded rod 126 may extend through the nut 127 and into an inner bore of the first post 122 toward the inflow end 109 of the frame 102. The nut 127 may 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 manner, 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 with the internal threads of the nut 127 prevents 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 may be held or supported by the nut 127 and may only be moved relative to the nut 127 and / or first post 122 by rotating the threaded rod 126 relative to the nut 127 and / or first post 122. In some embodiments, instead of using a nut 127, at least a portion of an internal bore of the first post 122 may be threaded. For example, a bore along an end 128 of the first post 122 may include internal threads that engage with the externally threaded rod 126 such that rotation of the threaded rod causes the threaded rod 126 to move axially relative to the first post 122 (as shown in FIG. 6 and described in more detail herein).

[0043] When the 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 function as one of the expansion and locking mechanisms 106. In some embodiments, the threaded rod 126 can extend through each pair of axially aligned posts 122, 124 such that all of the posts 122, 124 (with their corresponding rods 126) function as expansion and locking mechanisms 106. By way of example only, 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 some embodiments, not all pairs of posts 122, 124 need to be expansion and locking mechanisms (i.e., actuators). If the pair of posts 122, 124 is not used as an expansion and locking mechanism, the threaded rod 126 does not need to extend through the pair of posts 122, 124.

[0044] The threaded rod 126 can rotate relative to the nut 127, the first post 122, and the second post 124 to axially shorten and / or axially extend the frame 102, thereby radially expanding and / or radially compressing the frame 102 (and thus the prosthetic valve 100), respectively. Specifically, as the threaded rod 126 rotates 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, such that the gap G (FIG. 2B) separating the posts 122, 124 widens or narrows, and the prosthetic valve 100 radially compresses or expands, respectively. Thus, the gap G (FIG. 2B) between the first and second posts 122, 124 narrows as the frame 102 radially expands and widens as the frame 102 radially compresses.

[0045] The threaded rod 126 may extend proximally beyond the proximal end of the second post 124 and may include a head portion 131 at its proximal end that may serve at least two functions. First, the head portion 131 may detachably or releasably couple the threaded rod 126 to a respective actuator assembly of a delivery device that may be used to radially expand and / or radially compress the prosthetic valve 100 (e.g., the delivery device 200 of FIG. 3 as described herein). Second, the head portion 131 may prevent the second post 124 from moving proximally relative to the threaded rod 126 and may apply a distally directed force to the second post 124, such as when radially expanding the prosthetic valve 100. Specifically, the head portion 131 may be of a width greater than the diameter of the inner bore of the second post 124 to prevent the head portion 131 from moving into the inner bore of the second post 124. Thus, as the threaded rod 126 is threaded further into the nut 127, the head portion 131 of the threaded rod 126 is retracted closer to the nut 127 and the first post 122, thereby retracting the second post 124 toward the first post 122, and thereby shortening the artificial valve 100 axially and expanding it radially.

[0046] The threaded rod 126 may also include a stopper 132 (e.g., in the form of a nut, washer, or flange) disposed thereon. The stopper 132 may be disposed on the threaded rod 126 such that it is located within the gap G. Additionally, the stopper 132 may 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 may remain in a fixed axial position on the threaded rod 126 such that it moves in the same direction and at the same speed as the threaded rod 126.

[0047] Rotation of the threaded rod 126 in a first direction (e.g., clockwise) may cause corresponding axial movement of the first post 122 and the second post 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 may cause corresponding axial movement of the first post 122 and the second post 124 away from one another, thereby increasing the gap G and radially compressing the frame. As the threaded rod 126 rotates in the first direction, the head portion 131 of the rod 126 abuts an adjacent surface of the frame (e.g., the outflow apex 119b), while the nut 127 and the first post 122 move proximally along the threaded rod 126 toward the second post 124, thereby radially expanding the frame. As the frame 102 moves from the compressed configuration to the expanded configuration, the gap G between the first and second posts 122, 124 may narrow.

[0048] As the threaded rod 126 rotates in the second direction, the threaded rod 126 and 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 ). As the rod 126 further rotates in the second direction, the stopper 132 can apply a proximally directed force to the second post 124, radially compressing the frame 102. Specifically, during crimping / radial compression of the prosthetic valve 100, the threaded rod 126 can rotate in the second direction (e.g., counterclockwise) to cause the stopper 132 to press (i.e., provide a proximally directed force) against the inflow end 170 of the second post 124, such that the second post 124 moves away from the first post 122 and the prosthetic valve 100 elongates axially and compresses radially.

[0049] Thus, each of the second posts 124 can slide axially relative to a corresponding one of the first posts 122, but can be axially held and / or restrained between the head portion 131 and the stopper 132 of the threaded rod 126. 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 manner, the head portion 131 can apply a distally directed force to the second posts 124 to radially expand the prosthetic valve 100, while the stopper 132 can apply a proximally directed force to the second posts 124 to radially compress the prosthetic valve 100. As described herein, radially expanding the prosthetic valve 100 causes the prosthetic valve 100 to shorten axially, thereby causing the inflow and outflow ends 134, 136 (FIGS. 1A and 1B) of the prosthetic valve 100 to move axially toward each other, while radially compressing the prosthetic valve 100 causes the prosthetic valve 100 to elongate axially, causing the inflow and outflow ends 134, 136 to move axially away from each other.

[0050] In some embodiments, 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 a first direction moves the nut 127 proximally and expands the frame 102 radially, and rotation of the threaded rod 126 in a second direction moves the nut 127 distally and compresses the frame 102 radially.

[0051] As also introduced herein, some of the posts 104 may be configured as support posts 107. As shown in Figures 2A and 2B, the support posts 107 may extend axially between the inflow and outflow ends 109, 108 of the frame 102 and each may have an inflow end 138 and an outflow end 139. The outflow ends 139 of one or more of the support posts 107 may include a commissure support structure or member 144. The commissure support structure 144 may include a strut portion defining a commissure opening 146 therein.

[0052] The commissure openings 146 (sometimes referred to herein as "commissure windows 146") may extend radially through the thickness of the support posts 107 and may be configured to receive a portion of the valvular structure 150 (e.g., the commissures 152) to couple the valvular structure 150 to the frame 102. For example, each commissure 152 may be attached to a respective commissure support structure 144, for example, by inserting a pair of commissure tabs of adjacent leaflets 158 through the commissure openings 146 and suturing the commissure tabs to each other and / or to the commissure support structure 144. In some embodiments, the commissure openings 146 may be completely occluded by the support posts 107, such that a portion of the valvular structure 150 may be slid radially through its commissure openings 146 from the interior to the exterior of the frame 102 during assembly. In the illustrated embodiment, the commissure openings 146 have a substantially rectangular shape shaped and sized to receive the commissure tabs of two adjacent leaflets therethrough. However, in some embodiments, the commissure openings can have any of a variety of shapes, such as square, oval, square-oval, triangular, L-shaped, T-shaped, C-shaped, and the like.

[0053] The commissure openings 146 are spaced around the frame 102 (or are angularly spaced around the frame 102). The spacing may be even or uneven. In one embodiment, the commissure openings 146 are axially offset from the outflow end 108 of the frame 102 by an offset distance d3 (shown in FIG. 2A). By way of example, the offset distance d3 may be in the range of 2 mm to 6 mm. In general, the offset distance d3 should be selected such that the free edge (e.g., outflow edge) of the leaflet 158 ​​does not protrude from or beyond the outflow end 108 of the frame 102 when the leaflet is attached to the frame 102 via the commissure openings 146.

[0054] Frame 102 may include any number of support posts 107, any number of which may be configured as commissure support structures 144. For example, frame 102 may include six support posts 107, three of which may be configured as commissure support structures 144. However, in some embodiments, frame 102 may include more or less than six support posts 107 and / or more or less than three commissure support structures 144.

[0055] The inflow end 138 of each support post 107 may include an extension 154 (illustrated as a cantilevered post in FIGS. 2A and 2B ) that extends toward the inflow end 109 of the frame 102. Each extension 154 may include an opening 156 that extends radially through the thickness of the extension 154. In some embodiments, the extension 154 may extend such that the inflow edge of the extension 154 is aligned or substantially aligned with the inflow end 109 of the frame 102. In use, the extension 154 may prevent or reduce a portion of the outer skirt from extending radially inward, thereby preventing or reducing any obstruction of flow through the frame 102 caused by the outer skirt. The extension 154 may further function as a support to which the inner and / or outer skirts, and / or the leaflets, and / or portions of the connecting skirt 125 may be coupled. For example, the sutures used to connect the inner and / or outer skirts, and / or the valve leaflets, and / or the connecting skirt 125 may be wrapped around the extension 154 and / or extend through the opening 156.

[0056] As one example, each extension 154 may have an opening 156 (FIG. 2A) or other feature for receiving a suture or other attachment material to connect adjacent inflow edges 160 of the leaflets 158 (FIG. 1A), the outer skirt 103 (FIG. 1B), the connecting skirt 125, and / or the inner skirt. In some embodiments, the inflow edges 160 of each leaflet 158 ​​may be connected to a corresponding extension via a suture 135 (FIG. 1A).

[0057] In some embodiments, the outer skirt 103 can be attached around the outer surface of the frame 102 as shown in FIG. 1B, and the inflow edge (lower edge in FIG. 1B) of the outer skirt 103 can be attached to the inflow edge 160 of the leaflet 158 ​​already secured to the connecting skirt 125 and / or frame 102, and to the extension 154 of the frame by sutures 129. The outflow edge (upper edge in FIG. 1B) of the outer skirt 103 can be attached to selected struts by 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 160 prior to securing the leaflet edge to the frame, such that the inner skirt is between the leaflet and the inner surface of the frame. After the inner skirt and leaflets are secured in place, the outer skirt can be attached around the frame as described herein.

[0058] The frame 102 may be a unitary and / or fastener-less frame that can be constructed from a single piece of material (e.g., Nitinol, stainless steel, or cobalt chrome alloy), such as in the form of a tube. Multiple cells can be formed by removing portions of the single piece of material (e.g., via laser cutting). The threaded rod 126 can be formed separately and then inserted through a hole in the second (proximal) post 124 and threaded into the threaded nut 127.

[0059] In some embodiments, the frame 102 may be formed from a plastically expandable material, such as stainless steel or a cobalt chromium alloy. If the frame is formed from a plastically expandable material, the prosthetic valve 100 may be placed in a radially compressed state along the distal end of the delivery device for insertion into the patient's body. When at the desired implantation site, the frame 102 (and thus the prosthetic valve 100) may be radially expanded from the radially compressed state to a radially expanded state via actuation of an actuation assembly of the delivery device (as described further herein), which rotates the rod 126 and expands the frame 102. During delivery to the implantation site, the prosthetic valve 100 may be placed inside a delivery capsule (sheath) to protect the prosthetic valve from contacting the patient's vasculature, such as when the prosthetic valve is advanced through the femoral artery. The capsule also allows the prosthetic valve, when crimped onto the delivery device, to be held in a compressed state with a slightly smaller diameter and crimped profile than would be possible without the capsule, by preventing any recoil (expansion) of the frame.

[0060] In some embodiments, the frame 102 can be formed from a self-expandable material (e.g., Nitinol). If the frame 102 is formed from a self-expandable material, the prosthetic valve can be radially compressed and placed into a capsule of the delivery device, and the prosthetic valve can be maintained in a radially compressed state during delivery to the implantation site. Once the desired implantation site is reached, the prosthetic valve is deployed, or released, from the capsule. In some embodiments, the frame (and thus the prosthetic valve) can be partially self-expanding from a radially compressed state to a partially radially expanded state. The frame 102 (and thus the prosthetic valve 100) can be further radially expanded from a partially expanded state to a further radially expanded state via actuation of an actuation assembly of the delivery device (as described further herein), which rotates the rods 126 to expand the frame.

[0061] As introduced herein, the threaded rod 126 can removably couple the prosthetic valve 100 to an actuator assembly of the delivery device. Referring to FIG. 3 , this shows an exemplary delivery device 200 for delivering a prosthetic device or valve 202 (e.g., the prosthetic valve 100) to a desired implantation location. The prosthetic valve 202 can be removably coupled to the delivery device 200. It should be understood that the delivery device 200, as well as other delivery devices disclosed herein, may be used to implant prosthetic devices other than prosthetic valves, such as stents or grafts.

[0062] The delivery device 200 of the illustrated embodiment generally includes a handle 204, a first elongated shaft 206 (which in the illustrated embodiment comprises an outer shaft) extending distally from the handle 204, at least one actuator assembly 208 extending distally through the first shaft 206, a second elongated shaft 209 (which in the illustrated embodiment comprises an inner shaft) extending through the first shaft 206, and a nosecone 210 coupled to a distal end of the second shaft 209. The second shaft 209 and the nosecone 210 can define a guidewire lumen for advancing the delivery device over a guidewire through the patient's vasculature. The at least one actuator assembly 208 can be configured to radially expand and / or radially collapse the prosthetic valve 202 when actuated by one or more knobs 211, 212, 214, etc., included on the handle 204 of the delivery device 200.

[0063] While the illustrated embodiment shows two actuator assemblies 208 for illustrative purposes, it should be understood that one actuator assembly 208 may be provided for each actuator (e.g., actuator or threaded rod 126) on the prosthetic valve. For example, three actuator assemblies 208 may be provided in a prosthetic valve having three actuators. In some embodiments, there may be more or fewer actuator assemblies.

[0064] In some embodiments, the distal end 216 of the shaft 206 can be sized to accommodate 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 216 acts as a delivery sheath, or capsule, for the prosthetic valve during delivery.

[0065] The actuator assemblies 208 may be removably coupled to the prosthetic valve 202. For example, in the illustrated embodiment, each actuator assembly 208 may be coupled to a respective actuator (e.g., threaded rod 126) of the prosthetic valve 202. Each actuator assembly 208 may include a support tube and an actuator member. In operation, the actuator assembly may transmit a pushing force and / or a pulling force to a portion of the prosthetic valve to radially expand and collapse the prosthetic valve, as described above. The actuator assemblies 208 may be radially disposed at least partially within and may extend axially through one or more lumens of the first shaft 206. For example, the actuator assemblies 208 may extend through a central lumen of the shaft 206 or through separate respective lumens formed within the shaft 206.

[0066] The handle 204 of the delivery device 200 may include one or more control mechanisms (e.g., knobs or other actuation mechanisms) for controlling different components of the delivery device 200 for purposes of expanding and / or deploying the prosthetic valve 202. For example, in the illustrated embodiment, the handle 204 includes first, second, and third knobs 211, 212, and 214, respectively.

[0067] The first knob 211 may be a rotatable knob configured to generate axial movement of the first shaft 206 in a distal and / or proximal direction relative to the prosthetic valve 202 to deploy the prosthetic valve from the delivery sheath 216 once the prosthetic valve has been advanced to or adjacent a desired implantation location within 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., counterclockwise) can advance the sheath 216 distally. In some examples, the first knob 211 may be actuated by sliding or moving the first knob 211 axially, such as by pulling and / or pushing the knob. In some embodiments, actuation of the first knob 211 (rotation or sliding movement of the first knob 211) can generate axial movement of the actuator assembly 208 (and thus the prosthetic valve 202) relative to the delivery sheath 216 to advance the prosthetic valve distally from the sheath 216.

[0068] The second knob 212 may be a rotatable knob configured to radially expand and / or compress the prosthetic valve 202. For example, rotation of the second knob 212 may rotate a threaded rod of the prosthetic valve 202 via the actuator assembly 208. Rotation of the second knob 212 in a first direction (e.g., clockwise) may radially expand the prosthetic valve 202, and rotation of the second knob 212 in a second direction (e.g., counterclockwise) may radially collapse the prosthetic valve 202. In some examples, the second knob 212 may be actuated by sliding or moving the second knob 212 axially, such as by pulling and / or pushing the knob.

[0069] The third knob 214 may be a rotatable knob operably connected to the proximal end of each actuator assembly 208. The third knob 214 may be configured to retract the outer sleeve or support tube of each actuator assembly 208 to disconnect the actuator assembly 208 from the proximal portion of the actuator of the prosthetic valve (e.g., a threaded rod). Once the actuator assembly 208 is decoupled from the prosthetic valve 202, the delivery device 200 may be removed from the patient, leaving only the prosthetic valve 202 in the patient.

[0070] 4-5, which illustrate how each of the threaded rods 126 of the prosthetic device 100 can be removably coupled to an exemplary actuator assembly 300 (e.g., actuator assembly 208) of a delivery device (e.g., delivery device 200). Specifically, FIG. 5 illustrates how one of the threaded rods 126 can be coupled to the actuator assembly 300, and FIG. 4 illustrates how the threaded rod 126 can be removed from the actuator assembly 300.

[0071] As introduced herein, the actuator assembly 300 may be coupled to the head portion 131 of each threaded rod 126. The head portion 131 may be included at the proximal end 180 of the threaded rod 126 and may extend proximally beyond the proximal end of the second post 124 (FIG. 2A). The head portion 131 may comprise first and second protrusions 182 defining a channel or slot 184 therebetween and one or more shoulders 186. As discussed herein, the head portion 131 may 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 the head portion 131 abuts the outflow end 108 of the frame 102. In particular, the head portion 131 may abut the outflow apex 119b of the frame 102. Head portion 131 can be used, for example, to apply a distally directed force to second post 124 during radial expansion of frame 102 .

[0072] Each actuator assembly 300 may include 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 may extend through the outer sleeve 302. The outer sleeve 302 is shown transparent in FIGS. 4-5 for illustrative purposes. The distal ends of the outer sleeve 302 and the driver 304 may be configured to engage or abut the threaded rod 126 (e.g., head portion 131) and / or the proximal end (e.g., apex 119b) of the frame 102. The proximal portion of the outer sleeve 302 and the driver 304 may be operably coupled to a handle (e.g., handle 204) of the delivery device. The delivery device of this example may include the same features described above for the delivery device 200. In certain embodiments, the proximal end of each driver 304 may be operably connected to knob 212 such that rotation (clockwise or counterclockwise) of knob 212 causes a corresponding rotation of driver 304. The proximal end of each outer sleeve 302 may be operably connected to knob 214 such that rotation (clockwise or counterclockwise) of knob 214 causes a corresponding axial movement (proximal or distal) of sleeve 302 relative to driver 304. In some embodiments, the handle may include an electric motor for actuating these components.

[0073] The distal end of the driver 304 may include a central protrusion 306 configured to extend into the slot 184 of the threaded rod 126 and one or more flexible extended elements or arms 308 including protrusions or teeth 310 configured to be removably coupled to shoulders 186 of the threaded rod 126. The protrusions 310 may extend radially inward toward a longitudinal axis of the second actuation member 304. As shown in FIGS. 4-5, the extended elements 308 may be configured to be biased radially outward to an expanded state, for example, by shaping of the elements 308.

[0074] 5, to couple the actuator assembly 300 to the threaded rod 126, the driver 304 can be positioned such that the central projection 306 is disposed within the slot 184 (FIG. 4) and the projection 310 of the extended element 308 is positioned distal to the shoulder 186. As the outer sleeve 302 is advanced (e.g., distally) over the driver 304, the sleeve 302 compresses the extended elements 308 so that they abut and / or snap against the shoulder 186, thereby coupling the actuator assembly 300 to the threaded rod 126. Thus, the outer sleeve 302 effectively compresses and locks the extended elements 308 and the projection 310 of the driver 304 into engagement with (i.e., on) the shoulder 186 of the threaded rod 126, thereby coupling the driver 304 to the threaded rod 126.

[0075] The central projection 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, so that the driver 304 and the threaded rod 126 can be rotationally locked such that they co-rotate. When so coupled, the driver 304 can be rotated (e.g., using the knob 212 of the handle of the delivery device 200) to cause a corresponding rotation of the threaded rod 126 to radially expand or radially compress the prosthetic device. The central projection 306 can be configured (e.g., sized and shaped) to be advantageously spaced from the inner wall of the outer sleeve 302 such that the central projection 306 does not come into frictional contact with the outer sleeve 302 during rotation. In the illustrated embodiment, the central projection 306 has a substantially rectangular shape in cross section, although in some embodiments the projection 306 can have any of a variety of shapes, e.g., square, triangular, oval, etc. The slot 184 may be correspondingly shaped to receive the protrusion 306 .

[0076] The outer sleeve 302 can be advanced distally relative to the driver 304, past the extended element 308, until the outer sleeve 302 engages the frame 102 (e.g., the second post 124 of the frame 102). The distal end of the outer sleeve 302 can also include first and second support extensions 312 that define a gap or notch 314 between the extensions 312. The support extensions 312 can be oriented such that when the actuator assembly 300 is coupled to each threaded rod 126, the support extensions 312 extend partially over one adjacent end (e.g., the top end) of the second post 124 on opposing sides of the posts 124. In this manner, engagement of the support extensions 312 with the frame 102 can counteract a rotational force applied to the frame 102 by the rod 126 during expansion of the frame 102. Without a counter force acting against these rotational forces, the frame could tend to "shock" or rock in the direction of the rod rotation when actuated to expand the frame. The illustrated configuration is advantageous in that the outer sleeve, when engaged with the proximal post 124 of the frame 102, can prevent or reduce such shock or rocking movement of the frame 102 when it is radially expanded.

[0077] To separate the actuator assembly 300 from the prosthetic device 100, the sleeve 302 may be withdrawn proximally relative to the driver 304 until the sleeve 302 no longer covers the extended element 308 of the driver 304. As described herein, the extended element 308 may be naturally biased to a radially outward position in which the extended element 308 does not engage the shoulder 186 of the threaded rod 126, and thus the sleeve 302 may be used to hold the extended element 308 against the shoulder 186 of the threaded rod 126. Thus, once the sleeve 302 is withdrawn such that it no longer covers / restrains the extended element 308, the extended element 308 naturally and / or passively deflects and thereby releases from the shoulder 186 of the threaded rod 126, thereby allowing the driver 304 to be separated from the threaded rod 126.

[0078] The sleeve 302 can be advanced (moved distally) and / or retracted (moved proximally) relative to the driver 304 by an electric motor and / or by another suitable actuation mechanism via a control mechanism (e.g., knob 214) on the handle 204 of the delivery device 200. For example, a physician can rotate the knob 214 in a first direction to apply a distally directed force to the sleeve 302 and rotate 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 a first direction, the sleeve 302 can move distally relative to the driver 304, thereby advancing the sleeve 302 over the driver 304. When the sleeve 302 abuts the prosthetic device, the physician can rotate the knob 214 in a first direction to push the entire prosthetic device distally through the sleeve 302. Additionally, when the physician rotates the knob 214 in a second direction, the sleeve 302 may move proximally relative to the driver 304 , thereby withdrawing / retracting the sleeve 302 from the driver 304 .

[0079] Also disclosed herein are examples of prosthetic heart valve frames having an actuation assembly directly connected, for example, by a threaded connection, to one or more posts of the prosthetic heart valve frame. In some examples, the actuation assembly may include a bolt or rod having an internally threaded channel (also called a bore) that receives a corresponding externally threaded end section of a vertically oriented frame post. In some examples, the actuation assembly may include a bolt or rod having an externally threaded end that is received by a corresponding internally threaded channel or bore in the vertically oriented frame post.

[0080] Such an actuation assembly offers several advantages over those previously described. For example, because the actuation assembly is threadedly connected directly to the vertically oriented frame post, it does not need to include an actuator nut that allows for radial expansion and compression of the frame, and therefore does not need to widen the vertically oriented frame post to add a window to receive and accommodate the nut. This allows for a smaller vertically oriented frame post to reduce the overall crimp profile of the prosthetic heart valve, reducing the manufacturing complexity of the frame. Additionally, the elimination of the nut and nut window may improve frame durability by eliminating wear due to relative movement between the nut and nut window.

[0081] 6 shows a section of an exemplary prosthetic heart valve frame 400 having an actuator with externally threaded ends. As shown in FIG. 6, the prosthetic heart valve frame 400 may have the same or substantially the same configuration as the frame 102, as previously described, and may function in the same manner as described for the frame 102, except for the differences described herein. The prosthetic heart valve may include the frame 400 and any of the components described herein for the prosthetic heart valve 100 (e.g., the leaflets 158, inner and / or outer skirts, connecting members 125, etc.).

[0082] The frame 400 includes an inflow end 109, an outflow end 108, and a number of axially extending posts 104. The axial direction of the frame 400 is indicated by a longitudinal axis extending from the inflow end 109 to the outflow end 108, similar to axis 105 shown in FIGS. 2A and 2B. Some of the posts 104 may be arranged in axially aligned pairs of first and second struts or posts 402, 404. The posts 402, 404 may include first and second axially extending holes or channels 406, 408 that permit one or more components of an actuation assembly, such as an actuator 410. The actuator 410 (such as a threaded rod or bolt as shown) may extend through one or more channels 406, 408 to form an integrated expansion and locking mechanism, or actuator mechanism, configured to radially expand and compress the frame 400, as shown in FIG.

[0083] 6, the actuator 410 has a first end 412 (also referred to as the distal end 412) and a second end 414 (also referred to as the proximal end 414). The actuator 410 extends into and through the second bore 408. The first end 412 has an externally threaded portion 416 that extends into the first bore 406 and includes external threads that engage with internal threads formed along a corresponding internally threaded portion 418 of the first bore 406. The second end 414 of the actuator 410 can include a head portion 131 that is configured to be removably attached to a delivery system actuator assembly, such as the actuator assembly 300 discussed herein and shown in FIGS. 4 and 5.

[0084] In some embodiments, a stopper 420 may be positioned on the actuator 410 between the first post 402 and the second post 404. The stopper may be integrally formed with or fixedly coupled to the actuator 410 such that it does not move relative to the actuator 410 and thus remains in a fixed axial position on the actuator 410 and moves in the same direction and at the same speed as the actuator 410 when the frame is radially expanded and radially contracted.

[0085] 6 shows only a portion of the frame 400 having an actuator 410 extending axially through the first and second holes 406, 408 of a pair of posts 402, 404, it should be understood that the frame 400 may be similar or substantially identical to that shown in FIG. 6 and may comprise multiple frame sections arranged circumferentially to form the frame 400, similar to the frame 102 described herein and shown in FIGS. 1A-2B. In some embodiments, the actuator 410 extends axially through the first and second holes 406, 408 of each portion of the frame 400 as shown in FIG. 6. However, it should be understood that in some embodiments, one or more of the portions of the frame 400 may omit the actuator 410, and optionally omit the first and second holes 406, 408 as well. For example, in a frame including six substantially identical portions, such as that shown in FIG. 2A, there may be actuators extending through the channels 406, 408 of pairs of vertical posts 402, 404 of all six frame portions, or there may be actuators extending through the channels 406, 408 of pairs of vertical posts 402, 404 of fewer frame portions, such as five, four, three, two, or one frame portion.

[0086] Rotation of the actuator 410 in a first direction may cause corresponding axial movement of the first post 402 and the second post 404 toward one another, thereby decreasing the spacing between the first and second posts 402, 404 and radially expanding the frame, while rotation of the actuator 410 in a second direction opposite the first direction may cause corresponding axial movement of the first post 402 and the second post 404 away from one another, thereby increasing the spacing therebetween and radially compressing the frame.

[0087] As the actuator 410 rotates in a first direction, the head portion 131 of the actuator 410 abuts an adjacent surface of the frame (e.g., the outflow apex 119b) while the first post 402 translates proximally along the actuator toward the second post 404, thereby radially expanding the frame 400. As the frame 400 moves from the compressed configuration to the expanded configuration, the gap between the first post 402 and the second post 404 may narrow.

[0088] As the actuator 410 rotates in the second direction, the actuator 410 and stopper 420 move toward the outflow end 108 of the frame in the same manner as described herein and as shown in FIGS. 2A and 2B until the stopper 420 abuts the inflow end 170 of the second post 404. As the actuator 410 rotates further in the second direction, the stopper 420 can apply a proximally directed force to the second post 204, radially compressing the frame 400. Specifically, during crimping / radial compression of the frame 400, the actuator 410 can be rotated in the second direction to force the stopper 420 against the inflow end 170 of the second post 404, thereby moving the second post 404 away from the first post 402, and causing the frame 400 to elongate and radially compress.

[0089] The range of relative axial motion between the first post 402 and the second post 404 is defined by the axial length L1 of the first hole 406 in the first post 402, as shown in Figure 6. Thus, in some embodiments, the length L1 of the first hole 406 can be varied to accommodate different desired ranges of radial expansion and compression of the frame 400.

[0090] An exemplary prosthetic heart valve frame 500 having an actuation assembly directly connected to one or more struts of the frame is shown in Figures 7-9. As shown in Figure 9, the prosthetic heart valve frame 500 may have the same or substantially the same configuration as frames 102 and 400, as described above, and may function in the same manner as described above, except for the differences described herein. The prosthetic heart valve may include the frame 500 and any of the components described herein for the prosthetic heart valve 100 (e.g., leaflets 158, inner and / or outer skirts, connecting members 125, etc.).

[0091] As shown in FIG. 9, the frame 500 can include a plurality of axially extending posts 104. Some of the posts 104 can be arranged in an axially aligned pair of first and second posts 502, 504. The second post 504 can include a channel 506 through which an actuator 514 extends. The first post 502 can include a fixed end 508 (also referred to as a distal end 508) and a free end 510 (also referred to as a proximal end 510). The fixed end 508 can be attached to one or more of the components of the frame 500, such as the pair of struts 113, 115, as shown in FIG. 9. The free end 510 can further include an externally threaded rod 512 operably coupled to the actuator 514.

[0092] 9, the actuator 514 has a first end 516 (also referred to as the distal end 516) and a second end 518 (also referred to as the proximal end 518). The first end 516 may further include a cup structure 520 having an internally threaded channel 522 extending at least partially axially through a portion of the cup structure. The internally threaded channel 522 receives a corresponding externally threaded rod 512 and allows the actuator 514 to rotate in a first rotational direction and a second rotational direction relative to the first post 502. The second end 518 of the actuator 514 may include an enlarged head portion 131 extending through the channel 506 and disposed outside of the channel. The head portion 131 is configured to be removably attached to a delivery system actuator assembly, such as the actuator assembly 300 discussed herein and shown in FIGS. 4 and 5.

[0093] As shown, the cup structure 520 can have a larger diameter than the portion of the actuator 514 that extends between the cup structure 520 and the head portion 131. In some embodiments, the actuator 514 can be formed with an internally threaded bore 522 and can have a constant diameter along its length, except for the head portion 131.

[0094] In some embodiments, the stopper 524 may be positioned on the actuator 516 between the first post 502 and the second post 504. The stopper may be integrally formed with or fixedly coupled to the actuator 516 such that it does not move relative to the actuator 516 and thus remains at a fixed axial location on the actuator 516 and moves in the same direction and at the same speed as the actuator 516 as the frame is radially expanded and radially contracted.

[0095] 9 shows only a portion of the frame 500 having an actuator 516 operably coupled to components of the frame 500, it should be understood that in some embodiments, the frame 500 may be the same or substantially the same as that shown in FIG. 9 and may comprise multiple frame sections arranged circumferentially to form the frame 500, similar to the frame 102, as described herein and shown in FIGS. 1A-2B. In some embodiments, the actuator 516 extends axially through a hole 506 in each post 504 of the frame 500. However, it will be appreciated that in some embodiments, one or more of the portions of the frame 500 may omit the actuator 516, and optionally omit the hole 506. For example, in a frame including six substantially identical portions, such as that shown in FIG. 2A, there may be an actuator that extends through the channel 506 of the second vertical post 504 of all six frame portions, or there may be an actuator that extends through the channel 506 of the second vertical post 504 of fewer frame portions, such as five, four, three, two, or one frame portions.

[0096] Rotation of the actuator 516 in a first direction may cause corresponding axial movement of the first post 502 and the second post 504 toward one another, thereby decreasing the spacing between the first and second posts 502, 504 and radially expanding the frame, while rotation of the actuator 516 in a second direction opposite the first direction may cause corresponding axial movement of the first post 502 and the second post 504 away from one another, thereby increasing the spacing therebetween and radially compressing the frame.

[0097] 9, when frame 500 is in a radially compressed or partially radially compressed configuration, actuator 516 can be rotated in a first direction such that head portion 131 of actuator 516 abuts an adjacent surface of the frame (e.g., outflow apex 119b) and first post 502 translates proximally along the actuator toward second post 504, thereby radially expanding frame 500. As frame 500 moves from the compressed configuration to the expanded configuration (i.e., from the configuration shown in FIG. 9 to the configuration shown in FIGS. 7 and 8), the gap between first post 502 and second post 504 can narrow.

[0098] 7 and 8, when the frame 500 is in a radially expanded configuration or a partially radially compressed configuration, the actuator 516 can be rotated in a second direction such that the actuator 516 and stopper 524 move toward the outflow end 108 of the frame 500 until the stopper 524 abuts the inflow end 170 of the second post 504 in a manner identical to that described herein and as shown in FIGS. 2A and 2B. As the actuator 516 is further rotated in the second direction, the stopper 524 can apply a proximally directed force to the second post 504 to radially compress the frame 500. Specifically, during crimping / radial compression of the frame 500, the actuator 516 can be rotated in a second direction to force the stopper 526 against the inflow end 170 of the second post 504, thereby moving the second post 504 away from the first post 502 and causing the frame 500 to elongate and radially compress (i.e., from the configuration shown in Figures 7 and 8 to the configuration shown in Figure 9).

[0099] The range of relative axial motion between the first post 502 and the second post 504 is defined by the axial length L2 of the interior bore at the first end of the actuator 516, as shown in Figure 9. Thus, in some embodiments, the interior length L2 can be varied to accommodate different desired ranges of radial expansion and compression of the frame 500.

[0100] In this manner, the above-described embodiments may provide a frame suitable for use with prosthetic heart valves similar to those described above that may omit the actuator nut and corresponding window. Such embodiments may enable prosthetic heart valves with a narrower crimp profile and are not subject to wear that may result from relative movement between the actuator nut and surrounding components of the frame. Additionally, such embodiments may simplify the manufacturing process of the prosthetic valve since fewer components are required.

[0101] In some examples, a rotatable actuator (e.g., actuator 514) having an internally threaded bore can be implanted within an expandable frame for a prosthetic device (e.g., a prosthetic valve), the frame comprising a plurality of inner and outer struts pivotally connected to one another at a plurality of pivot joints or hinges. Examples of such frames are disclosed in U.S. Patent Publication Nos. 2018 / 0153689 and 2018 / 0344456, which are incorporated herein by reference. In such examples, one or more pairs of rotatable actuators having internal threads and fixation posts having external threads can be attached to an inner surface of the frame and / or an outer surface of the frame.

[0102] Any of the systems, devices, apparatus, etc. herein may be sterilized (e.g., using heat / heat, pressure, steam, radiation, and / or chemicals, etc.) to ensure safe use on patients, and any of the methods herein may include sterilizing the associated system, device, apparatus, etc. as one of the method steps. Examples of heat / heat sterilization include steam sterilization and autoclave sterilization. Examples of radiation used for sterilization include, but are not limited to, gamma radiation, ultraviolet light, and electron beam. Examples of chemicals used for sterilization include, but are not limited to, ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde, and glutaraldehyde. Hydrogen peroxide sterilization may be performed, for example, using hydrogen peroxide plasma.

[0103] delivery technology To implant the prosthetic valve into the native aortic valve via a transfemoral delivery approach, the prosthetic valve is mounted in a radially compressed state along the distal end of a delivery device. The prosthetic valve and the distal end of the delivery device are inserted into the femoral artery and advanced into and through the descending aorta, around the aortic arch, and through the ascending aorta. The prosthetic valve is positioned inside the native aortic valve and radially expanded (e.g., by inflating a balloon, by actuating one or more actuators of the delivery device, or by deploying the prosthetic valve from a delivery capsule to allow the prosthetic valve to self-expand). Alternatively, the prosthetic valve can be implanted inside the native aortic valve in a transapical procedure, in which the prosthetic valve (on the distal end of the delivery device) 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 inside the native aortic valve. Alternatively, in a transaortic procedure, the prosthetic valve (on the distal end of a delivery device) is introduced into the aorta through a surgical incision in the ascending aorta, such as by a partial J sternotomy or a right parasternal minithoracotomy, and then advanced through the ascending aorta toward the native aortic valve.

[0104] To implant the prosthetic valve inside the native mitral valve via a transseptal delivery approach, the prosthetic valve is mounted in a radially compressed state along the distal end of a delivery device. The prosthetic valve and the distal end of the delivery device are inserted into the femoral vein and 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, the prosthetic valve can be implanted inside the native mitral valve in a transapical procedure, in which the prosthetic valve (on the distal end of the delivery device) 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 inside the native mitral valve.

[0105] To implant the prosthetic valve inside the native tricuspid valve, the prosthetic valve is mounted in a radially compressed state along the distal end of a delivery device. The prosthetic valve and the distal end of the delivery device are inserted into the femoral vein and advanced into and through the inferior vena cava into the right atrium, where the prosthetic valve is positioned inside the native tricuspid valve. A similar approach can be used to implant a prosthetic valve inside the native pulmonary valve or pulmonary artery, except the prosthetic valve is advanced through the native tricuspid valve into the right ventricle and toward the pulmonary valve / artery.

[0106] Another delivery approach is the transatrial approach, where the prosthetic valve (on the distal end of the delivery device) is inserted through an incision in the chest and an incision is made through the atrial wall (either the right or left atrium) to access either of the native heart valves. Atrial delivery can also be performed endovascularly, such as from a pulmonary vein. Yet another delivery approach is the transventricular approach, where the prosthetic valve (on the distal end of the delivery device) is inserted through an incision in the chest and an incision is made through the wall of the right ventricle (typically at or near the base of the heart) to implant the prosthetic valve within the native tricuspid valve or within the native pulmonary valve or within the pulmonary artery.

[0107] In all delivery approaches, the delivery device may be advanced over a guidewire and / or over an introducer sheath previously inserted into the patient's vasculature. Moreover, the disclosed delivery approaches are not intended to be limiting. Any of the prosthetic valves disclosed herein may be implanted using any of a variety of delivery procedures and any of a variety of delivery devices known in the art.

[0108] Additional Examples of the Disclosed Technology In view of the above implementations of the disclosed subject matter, the present application discloses additional embodiments, as listed below. It should be noted that one feature of an embodiment in isolation, or two or more features of that embodiment taken in combination, and optionally in combination with one or more features of one or more additional embodiments, are also further embodiments that fall within the disclosure of the present application.

[0109] Example 1. A prosthetic valve comprising: a radially expandable frame including a plurality of interconnected struts, the frame being radially expandable between a radially compressed state and a radially expanded state, the frame including at least one axially oriented first post having an externally threaded portion; a valve structure disposed within the frame and configured to regulate unidirectional blood flow through the frame; and at least one rotatable actuator operably coupled to the frame, the actuator comprising an internally threaded bore that receives the externally threaded portion of the post, the actuator being rotatable in a first rotational direction relative to the post to generate a radial expansion of the frame from the radially compressed state to the radially expanded state.

[0110] Example 2. The prosthetic valve of any of the examples described herein, particularly Example 1, wherein the frame comprises at least one axially oriented second post having a channel extending therethrough, and the actuator extends through the channel.

[0111] Example 3. The prosthetic valve of any of the embodiments described herein, particularly Example 2, further comprising a stopper mounted on the actuator between the first axially oriented post and the second axially oriented post.

[0112] Example 4. The prosthetic valve of any of the examples described herein, particularly Examples 2-3, wherein the plurality of interconnected struts form a plurality of outer cells and a plurality of inner cells, each inner cell having a first apex and a second apex and disposed within a corresponding outer cell.

[0113] Example 5. The prosthetic valve of any of the examples described herein, particularly Example 4, wherein the axially oriented first post extends axially from the first apex of an inner cell to the second apex of the same inner cell.

[0114] Example 6. The prosthetic valve of any of the examples described herein, particularly Examples 4-5, wherein the axially oriented second post extends from the second apex of the inner cell to the apex of the outer cell.

[0115] Example 7. Any of the examples described herein, particularly examples 1-6, wherein the prosthetic valve comprises two or more actuators and a corresponding number of axially oriented first posts having externally threaded portions, each actuator comprising an internally threaded bore that receives the threaded portion of a corresponding axially oriented first post.

[0116] Example 8. The prosthetic valve of any of the embodiments described herein, particularly Examples 1-7, wherein the radially expandable frame is formed as a unitary structure.

[0117] Example 9. The prosthetic valve of any of the embodiments described herein, particularly Examples 1-8, wherein the radially expandable frame comprises a plastically expandable material.

[0118] Example 10. The prosthetic valve of any of the examples described herein, particularly Examples 1-9, wherein the radially expandable frame comprises a shape memory alloy.

[0119] Example 11. The prosthetic valve of any of the embodiments described herein, particularly example 10, wherein said shape memory alloy is Nitinol.

[0120] Example 12. The prosthetic valve of any of the embodiments described herein, particularly embodiments 1-11, wherein the head portion of the actuator is configured to be removably connected to a component of a delivery device actuator.

[0121] Example 13. The prosthetic valve of any of the embodiments described herein, particularly Examples 1-12, further comprising a sealing skirt attached around the outer surface of the frame.

[0122] Example 14. An artificial valve comprising: an annular frame including a first end, a second end, a longitudinal axis extending from the first end to the second end, and a plurality of struts forming a plurality of cells between the first end and the second end; a valve structure disposed within the frame and configured to regulate unidirectional blood flow through the frame; a plurality of vertical posts oriented parallel to the longitudinal axis; and an actuation member having a first end and a second end, the first end comprising an axially oriented internally threaded bore, the internally threaded bore of the actuation member being operably coupled to an externally threaded portion of a first vertical post of the plurality of vertical posts, the actuation member being rotatable in a first rotational direction relative to the first vertical post to radially expand the frame from a radially compressed state to a radially expanded state, and being rotatable in a second rotational direction to radially compress the frame from the radially expanded state to the radially compressed state.

[0123] Example 15. The prosthetic valve of any of the embodiments described herein, particularly Example 14, wherein the first vertical post is one of a pair of circumferentially aligned vertical posts comprising the first vertical post and a second vertical post.

[0124] Example 16. The prosthetic valve of any of the examples described herein, particularly example 15, wherein the second post comprises an axially oriented channel through which the actuation member extends.

[0125] Example 17. An artificial valve as described in any of the embodiments described herein, particularly Examples 14-16, wherein the plurality of cells comprises a plurality of outer cells extending from the first end of the frame to the second end of the frame, and a plurality of inner cells, each disposed within a corresponding outer cell.

[0126] Example 18. An artificial valve as described in any of the embodiments described herein, particularly Example 17, wherein the first vertical post has a first end and a second end, the first end being connected to a first apex of the inner cell, the first vertical post extending axially toward a second apex of the inner cell, and the first vertical post being operably coupled to the actuation member at a position between the first apex and the second apex.

[0127] Example 19. An artificial valve as described in any of the embodiments described herein, particularly Examples 15-18, further comprising a stopper mounted on the actuation member between the first vertical post and the second vertical post.

[0128] Example 20. The prosthetic valve of any of the embodiments described herein, particularly embodiments 14-19, wherein the prosthetic valve comprises two or more actuation members, each having an axially oriented internally threaded bore operably coupled to an externally threaded portion of one of the axially oriented vertical posts.

[0129] Example 21 The prosthetic valve of any of the embodiments described herein, particularly Examples 14-20, wherein the prosthetic valve comprises a shape memory alloy.

[0130] Example 22. The prosthetic valve of any of the embodiments described herein, particularly example 21, wherein the shape memory alloy is Nitinol.

[0131] Example 23. The prosthetic valve of any of the embodiments described herein, particularly embodiments 14-22, wherein the second end of the actuation member is configured to be removably attached to a component of a delivery device.

[0132] Example 24. The prosthetic valve of any of the embodiments described herein, particularly Examples 14-23, further comprising a sealing skirt extending around the outer surface of the frame.

[0133] Example 25. A medical assembly comprising: a prosthetic heart valve having a radially expandable frame; a valve structure disposed within the frame and configured to regulate unidirectional blood flow through the frame; a vertically oriented first post; at least one actuator operably coupled to the vertically oriented first post; and a delivery device removably attached to the actuator, wherein the frame has a plurality of interconnected struts and is radially expandable between a radially compressed state and a radially expanded state, the vertically oriented first post having an externally threaded end, the actuator having an internally threaded end that receives the externally threaded end of the vertically oriented first post, and the actuator is rotatable in a first rotational direction relative to the first post to generate radial expansion of the frame.

[0134] Example 26 The medical device of any of the embodiments described herein, particularly example 25, wherein the frame comprises a vertically oriented second post having an axially extending channel through which the actuator extends.

[0135] Example 27. Any of the embodiments described herein, particularly embodiments 25-26, further comprising a stopper disposed on the actuator between the first post and the second post.

[0136] Example 28. A medical assembly as described in any of the embodiments described herein, particularly embodiments 25-27, wherein the artificial valve comprises two or more actuators and a plurality of first posts, each actuator having an axially oriented internally threaded bore operably connected to the externally threaded end of a corresponding first post.

[0137] Example 29. A medical assembly described in any of the embodiments described herein, particularly Examples 25 to 28, wherein the radially expandable frame includes a plurality of outer cells arranged in an annular configuration and a plurality of inner cells each disposed within a corresponding outer cell.

[0138] Example 30 The medical assembly of any of the embodiments described herein, particularly example 29, wherein the first post is at least partially disposed within the inner cell.

[0139] Example 31. The medical assembly of any of the examples described herein, particularly examples 25-30, wherein the prosthetic valve comprises a shape memory alloy.

[0140] Example 32 The medical assembly of any of the embodiments described herein, particularly example 31, wherein the shape memory alloy is Nitinol.

[0141] Example 33. The medical assembly of any of the examples described herein, particularly examples 25-32, further comprising a sealing skirt extending around an outer surface of the frame.

[0142] Example 34. A medical assembly as described in any of the embodiments described herein, particularly embodiments 25 to 33, wherein the delivery device comprises an actuation assembly configured to be removably connected to the actuator of the prosthetic valve, the actuation assembly being configured to rotate the actuator when so coupled to the actuator.

[0143] Example 35. The expandable frame, leaflet, or prosthetic heart valve of any of the preceding examples, wherein the expandable frame, leaflet, or prosthetic heart valve is sterilized.

[0144] Example 36. A method comprising sterilizing the prosthetic heart valve, the frame, the medical assembly, or the stent of any of the preceding examples.

[0145] Features described herein with respect to any embodiment may be combined with other features described in any one or more of the embodiments, unless otherwise stated. For example, any one or more features with respect to one frame or actuator may be combined with any one or more features with respect to another frame or actuator.

[0146] In view of the many possible manners to which the principles of the present disclosure may be applied, it will be recognized that the illustrated configurations are illustrative examples of the disclosed technology and should not be taken as limiting the scope of the present disclosure or the claims that follow. Rather, the scope of the claimed subject matter is defined by the following claims, and equivalents thereof.

Claims

1. An artificial valve, a radially expandable frame including a plurality of interconnected struts, the frame being radially expandable between a radially compressed state and a radially expanded state, the frame including at least one axially oriented first post having an externally threaded portion; a valve structure disposed within the frame and configured to regulate unidirectional blood flow through the frame; at least one rotatable actuator operably coupled to the frame; the actuator comprises an internally threaded bore that receives the externally threaded portion of the post, the actuator being rotatable in a first rotational direction relative to the post to generate radial expansion of the frame from the radially compressed state to the radially expanded state.

2. 10. The prosthetic valve of claim 1, wherein the frame comprises at least one axially oriented second post having a channel extending therethrough, the actuator extending through the channel.

3. 3. The prosthetic valve of claim 2, further comprising a stopper mounted on the actuator between the first axially oriented post and the second axially oriented post.

4. 4. The prosthetic valve of claim 2 or 3, wherein the plurality of interconnected struts form a plurality of outer cells and a plurality of inner cells, each inner cell having a first apex and a second apex and disposed within a corresponding outer cell.

5. 5. The prosthetic valve of claim 4, wherein the first axially oriented post extends axially from the first apex of an inner cell to the second apex of the same inner cell.

6. 6. The prosthetic valve of claim 4 or 5, wherein the axially oriented second post extends from a second apex of the inner cell to an apex of the outer cell.

7. The artificial valve according to any one of claims 1 to 6, wherein the artificial valve comprises two or more actuators and a corresponding number of axially oriented first posts having externally threaded portions, each actuator comprising an internally threaded bore that receives the externally threaded portion of a corresponding axially oriented first post.

8. The prosthetic valve of any of claims 1 to 7, wherein the actuator head portion is configured to be removably connected to a delivery device actuator component.

9. The prosthetic valve of any one of claims 1 to 8, further comprising a sealing skirt attached around an outer surface of the frame.

10. An artificial valve, an annular frame including a first end, a second end, a longitudinal axis extending from the first end to the second end, and a plurality of struts forming a plurality of cells between the first end and the second end; a valve structure disposed within the frame and configured to regulate unidirectional blood flow through the frame; a plurality of vertical posts oriented parallel to the longitudinal axis; an actuation member having a first end and a second end, the first end including an axially oriented internally threaded bore; the internally threaded bore of the actuation member is operably coupled to an externally threaded portion of a first vertical post of the plurality of vertical posts; the actuation member is rotatable in a first rotational direction relative to the first vertical post to radially expand the frame from a radially compressed state to a radially expanded state, and in a second rotational direction to radially compress the frame from the radially expanded state to the radially compressed state.

11. 11. The prosthetic valve of claim 10, wherein the plurality of cells comprises a plurality of outer cells extending from the first end of the frame to the second end of the frame and a plurality of inner cells, each disposed within a corresponding outer cell.

12. 12. The prosthetic valve of claim 11, wherein the first vertical post has a first end and a second end, the first end being connected to a first apex of the inner cell, the first vertical post extending axially toward a second apex of the inner cell, and the first vertical post being operably coupled to the actuation member at a location between the first apex and the second apex.

13. The artificial valve of any one of claims 10 to 12, further comprising a stopper mounted on the actuation member between the first vertical post and a second vertical post axially spaced from the first vertical post.

14. The prosthetic valve of any one of claims 10 to 13, wherein the prosthetic valve comprises two or more actuation members, each having an axially oriented internally threaded bore operably coupled to an externally threaded portion of one of the vertical posts.

15. 1. A medical assembly comprising: A prosthetic heart valve having a radially expandable frame, a valve structure disposed within the frame and configured to regulate unidirectional blood flow through the frame, a vertically oriented first post, and at least one actuator operably coupled to the vertically oriented first post. a delivery device removably attached to the actuator; the frame having a plurality of interconnected struts and being radially expandable between a radially compressed state and a radially expanded state; the vertically oriented first post having an externally threaded end; a medical assembly, the actuator having an internally threaded end that receives the externally threaded end of the vertically oriented first post, the actuator being rotatable in a first rotational direction relative to the vertically oriented first post to generate radial expansion of the frame;

16. The medical assembly of claim 15 , wherein the frame comprises a vertically oriented second post that includes an axially extending channel through which the actuator extends.

17. 17. The medical assembly of claim 16, further comprising a stopper disposed on the actuator between the first vertically oriented post and the second vertically oriented post.

18. 18. The medical assembly of any of claims 15 to 17, wherein the prosthetic heart valve comprises two or more actuators and a plurality of first posts, each actuator having an axially oriented, internally threaded bore operably connected to an externally threaded end of a corresponding first post.

19. 19. The medical assembly of any of claims 15 to 18, wherein the radially expandable frame includes a plurality of outer cells arranged in an annular configuration and a plurality of inner cells each disposed within a corresponding outer cell.

20. 20. The medical assembly of any of claims 15 to 19, wherein the delivery device comprises an actuation assembly configured to be removably connected to the actuator of the prosthetic heart valve, the actuation assembly configured to rotate the actuator when so coupled to the actuator.

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