DELIVERY DEVICE FOR A MECHANICALLY EXPANDABLE VALVE - Patent application

Abstract

The delivery device may include one or more actuator assemblies extending from the handle. Each actuator assembly may include an outer sleeve and an actuation member extending with an engagement portion configured to releasably couple an actuator of a prosthetic heart valve. The engagement portion may include a driver head with an engagement element configured to engage a corresponding engagement element in a head portion of the actuator, and a gripper member with a plurality of arms configured to releasably couple the head portion of the actuator. Each arm may have a distal end portion with a circumferential width greater than the circumferential width of a proximal end portion and an arcuate cross-sectional shape. Rotation of the actuation member in a first direction may radially expand the prosthetic heart valve, and rotation of the actuation member in a second direction may radially compress the prosthetic heart valve.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Patent Application No. 63 / 325,525, filed March 30, 2022, which is incorporated by reference in its entirety.

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

[0003] The human heart can suffer from a variety of valvular diseases. These valvular diseases can cause serious malfunctions of the heart, eventually requiring repair of the native valve or replacement of the native valve with an artificial valve. Numerous repair devices (e.g., stents) and artificial valves are known, as are numerous methods for implanting the devices and valves in humans. Percutaneous and minimally invasive surgical approaches are used in a variety of 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 embodiment, the artificial heart valve may 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 activating a mechanical actuator that applies an expansive force to the prosthetic heart valve, or by deploying the prosthetic heart valve from a sheath of a delivery device, allowing it to self-expand to its functional size.

[0004] A prosthetic heart valve that relies on a mechanical actuator for expansion may be referred to as a "mechanically expandable" prosthetic heart valve. A mechanically expandable prosthetic heart valve may provide one or more advantages over a self-expandable prosthetic heart valve and over a balloon-expandable prosthetic heart valve. For example, a mechanically expandable prosthetic heart valve may be expanded to a variety of diameters. A mechanically expandable prosthetic heart valve may also be compressed (e.g., for repositioning and / or for retrieval) after the initial expansion. However, some known devices and methods may cause rotation or movement of the prosthetic valve during expansion.

[0005] Despite recent advances in percutaneous valve technology, a need remains for improved transcatheter heart valves and delivery devices for such valves. Summary of the Invention

[0006] Described herein are prosthetic heart valves, delivery devices, and methods for implanting the prosthetic heart valves. The disclosed prosthetic heart valves, delivery devices, and methods may, for example, enable the delivery device to radially expand the prosthetic heart valve at a selected implantation site. Thus, the devices and methods disclosed herein may overcome, among other things, one or more deficiencies associated with typical prosthetic heart valves and their delivery devices.

[0007] A delivery device for a prosthetic implant may include a handle and one or more shafts coupled to the handle.

[0008] In some embodiments, the delivery device may include one or more actuator assemblies extending from the handle and configured to actuate one or more actuators of the prosthetic heart valve to radially expand and radially compress the prosthetic heart valve.

[0009] In some embodiments, the actuator assemblies may each include a driver and an outer sleeve, hi some embodiments, the driver may have an engagement portion including a driver head and a gripper member.

[0010] In some embodiments, the outer sleeve may include one or more support extensions extending partially over a radially inner or radially outer surface of the frame, the support extensions configured to inhibit rotation of the frame relative to the one or more actuator assemblies during expansion or compression of the prosthetic valve.

[0011] In some embodiments, the gripper member comprises a plurality of arms configured to releasably couple to a head portion of an actuator of a prosthetic valve. In some embodiments, a distal end portion of each arm includes a radially inwardly extending tine, each tine including an angled proximal surface. In some embodiments, each arm has a uniform thickness from the proximal end portion to the distal end portion of the arm.

[0012] In an exemplary embodiment, the delivery device may include one or more actuator assemblies extending from a handle. Each actuator assembly may include an outer sleeve and an actuation member extending through the outer sleeve and having a distal end portion configured to releasably couple an actuator of a prosthetic heart valve. The distal end portion may include a driver head including an engagement member extending distally from a body of the driver head, the engagement member configured to extend into a corresponding recess in a head portion of the actuator, and a gripper member including a plurality of arms configured to releasably couple the head portion of the actuator. Each of the plurality of arms may include a distal end portion having teeth extending radially inward toward a longitudinal axis of the actuation member, and each arm may have an arcuate cross-sectional shape. Rotation of the actuation member in a first direction radially expands the prosthetic heart valve, and rotation of the actuation member in a second direction radially compresses the prosthetic heart valve.

[0013] In a representative example, the assembly may include a prosthetic heart valve and a delivery device. The prosthetic heart valve may include a radially expandable and compressible frame having an inflow end portion and an outflow end portion, and one or more actuators. The actuator may have a body and a head portion, the actuator configured to radially expand the frame upon rotation of the one or more actuators, and the head portion may include a central recess and a circumferentially extending recess. The delivery device may include a handle and one or more actuator assemblies extending from the handle. Each actuator assembly may include an outer sleeve and an actuating member extending through the outer sleeve, the actuating member having a distal end portion. The distal end portion may include a driver head including an engagement member extending distally from a body of the driver head that extends into the central recess of the respective actuator, and a gripper member including a plurality of arms configured to removably couple the head portion of the respective actuator, the plurality of arms each including a distal end portion having teeth that extend into the circumferential recess of the respective actuator. Rotation of the actuating member in a first direction radially expands the prosthetic heart valve, and rotation of the actuating member in a second direction radially compresses the prosthetic heart valve.

[0014] In an exemplary embodiment, the method may include advancing an actuation member of an actuator assembly of a delivery device axially relative to an actuator of a radially expandable and compressible prosthetic valve such that a plurality of arms of the actuation member are advanced over a head portion of the actuator, the head portion including a central recess and a circumferential recess. The method may further include continuing to advance the actuation member such that tines extending radially inward from the plurality of arms are disposed within the circumferential recesses and an engagement member extending distally from the actuation member is disposed within the central recess, and advancing an outer sleeve of the actuator assembly over the actuation member such that the plurality of arms are radially compressed, thereby retaining the tines within the circumferential recesses and coupling the actuator assembly to the prosthetic valve.

[0015] In another exemplary embodiment, the delivery device may include one or more actuator assemblies extending from a handle. Each actuator assembly may include an outer sleeve and an actuation member extending through the outer sleeve and having a distal end portion configured to releasably couple an actuator of a prosthetic heart valve. The distal end portion may include a driver head including an engagement member extending distally from a body of the driver head, the engagement member configured to extend into a corresponding recess in a head portion of the actuator, the engagement member including one or more surfaces configured to engage corresponding surfaces of the corresponding recess, and a gripper member including a plurality of arms configured to releasably couple the head portion of the actuator, each of the plurality of arms including a distal end portion having teeth extending radially inward toward a longitudinal axis of the actuation member, the distal end portion of each arm having an increased circumferential width relative to the body of the arm. Rotation of the actuation member in a first direction radially expands the prosthetic valve and rotation of the actuation member in a second direction radially compresses the prosthetic valve.

[0016] In an exemplary embodiment, an implantable prosthetic device may include a radially expandable and compressible frame having an inflow end portion and an outflow end portion. The frame may include a plurality of posts, one or more of which are configured as an actuation mechanism including a first frame member having a first inner hole, a second frame member having a second inner hole, the first and second frame members being axially spaced from one another, an actuator, and a plurality of struts connecting adjacent posts to one another. The actuator may have an external threaded surface and may extend through the first and second inner holes. The actuator may further include a body and a head portion, the head portion including a circumferential recess. Rotation of the actuator in a first direction causes the first and second frame members to move axially toward one another, radially expanding the prosthetic device.

[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 concepts that are further described in the Detailed Description below. 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. The above 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 1] FIG. 1 is a perspective view of an example prosthetic heart valve. [Diagram 2] FIG. 2 is a side view of a delivery device for a prosthetic heart valve, according to one embodiment. [Diagram 3] FIG. 3 is a perspective view of a frame of a prosthetic heart valve comprising multiple actuator mechanisms, one of which is shown coupled to an actuator assembly of a delivery device, according to one embodiment. [Figure 4] 4 is a perspective view of a portion of the actuator mechanism and actuator assembly of FIG. [Diagram 5] 5 is a perspective view of a portion of the actuator mechanism and actuator assembly of FIG. [Figure 6] FIG. 6 is a perspective view of a portion of the actuator mechanism and actuator assembly of FIG. 4, with the outer sleeve shown in transparency. [Figure 7] 7 is a perspective view of a portion of the actuator mechanism and actuator assembly of FIG. [Figure 8] FIG. 8 is a perspective view of a portion of the frame and actuator assembly of FIG. 3 shown connected together. [Figure 9] FIG. 9 is a perspective view of a portion of the frame and actuator assembly of FIG. 3 shown coupled together with an outer sleeve which is shown transparent. [Figure 10] FIG. 10 is a perspective view of a portion of the frame and actuator assembly of FIG. 3 shown connected together. [Figure 11] FIG. 11 is a partial cross-sectional view of a portion of the frame and actuator assembly of FIG. 3 shown connected together. [Figure 12] FIG. 12 is a perspective view of an example prosthetic heart valve. [Figure 13] 13 is a perspective view of a portion of the frame of the prosthetic heart valve of FIG. 12. FIG. [Figure 14] FIG. 14 is a top schematic view of the prosthetic heart valve of FIG. [Figure 15] FIG. 15 is a perspective view of a threaded rod of an actuator mechanism according to one embodiment. [Figure 16] FIG. 16 is a side view of a portion of the threaded rod of FIG. [Figure 17] FIG. 17 is an end view of the threaded rod of FIG. [Figure 18] FIG. 18 is a perspective view of a portion of an outer sleeve of an actuator assembly according to one embodiment. [Figure 19] FIG. 19 is a perspective view of a portion of a driver of an actuator assembly according to one embodiment. [Figure 20] 20 is a perspective view of a driver head of the driver of FIG. 19. FIG. [Figure 21] 21 is a perspective view of a gripper member of the driver of FIG. 19. FIG. [Figure 22] 22-25 show perspective views of an exemplary method for separating an actuator assembly from an actuator mechanism of a prosthetic heart valve, according to one embodiment. [Figure 23] 22-25 show perspective views of an exemplary method for separating an actuator assembly from an actuator mechanism of a prosthetic heart valve, according to one embodiment. [Figure 24]22-25 show perspective views of an exemplary method for separating an actuator assembly from an actuator mechanism of a prosthetic heart valve, according to one embodiment. [Diagram 25] 22-25 show perspective views of an exemplary method for separating an actuator assembly from an actuator mechanism of a prosthetic heart valve, according to one embodiment. [Figure 26] 26-28 show cross-sectional side views of an exemplary method for decoupling the actuator assemblies of FIGS. 22-25. [Figure 27] 26-28 show cross-sectional side views of an exemplary method for decoupling the actuator assemblies of FIGS. 22-25. [Figure 28] 26-28 show cross-sectional side views of an exemplary method for decoupling the actuator assemblies of FIGS. 22-25. [Figure 29] FIG. 29 is a perspective view of a portion of an exemplary frame for a prosthetic heart valve coupled to an actuator assembly, according to one embodiment. [Diagram 30] 30-32 show perspective views of an exemplary method for separating the actuator assembly of FIG. 29 from an actuator mechanism of a prosthetic heart valve. [Diagram 31] 30-32 show perspective views of an exemplary method for separating the actuator assembly of FIG. 29 from an actuator mechanism of a prosthetic heart valve. [Diagram 32] 30-32 show perspective views of an exemplary method for separating the actuator assembly of FIG. 29 from an actuator mechanism of a prosthetic heart valve. [Diagram 33] 33-35 show cross-sectional views of an exemplary method for separating the actuator assemblies of FIGS. 30-32. [Diagram 34] 33-35 show cross-sectional views of an exemplary method for separating the actuator assemblies of FIGS. 30-32. [Diagram 35] 33-35 show cross-sectional views of an exemplary method for separating the actuator assemblies of FIGS. 30-32. [Diagram 36] FIG. 36 is a perspective view of a head portion of a threaded rod of a frame of a prosthetic heart valve, according to one embodiment. [Figure 37] FIG. 37 is a perspective view of a driver head of a driver of an actuator assembly, according to one embodiment. [Figure 38] FIG. 38 is a perspective view of a gripper member of a driver of an actuator assembly according to one embodiment. [Figure 39] FIG. 39 is a perspective view of a portion of an exemplary frame for a prosthetic heart valve comprising the threaded rod of FIG. 36 and a portion of an actuator assembly comprising the driver head and gripper members of FIGS. 37-38, according to one embodiment. [Diagram 40] 40 is a perspective view of the actuator assembly of FIG. 39 coupled to a portion of the exemplary prosthetic heart valve frame of FIG. 39, according to one embodiment. [Diagram 41] 41 is a cross-sectional view of the actuator assembly of FIG. 39 coupled to a portion of the exemplary prosthetic heart valve frame of FIG. 39, according to one embodiment. [Diagram 42] FIG. 42 is a perspective view of a hypotube portion of an outer sleeve of an actuator assembly according to one embodiment. [Diagram 43] FIG. 43 is a perspective view of an actuator assembly comprising the hypotube portion of FIG. 42 coupled to a portion of an exemplary prosthetic valve frame, according to one embodiment. [Diagram 44] 44 is a perspective view of the actuator assembly of FIG. 43 coupled to the prosthetic heart valve frame of FIG. 43, with the outer sleeve shown transparent for illustrative purposes. [Diagram 45] 45 is a side view of a portion of the outer sleeve of the actuation assembly including the hypotube portion of FIG. 42, showing the hypotube in an expanded configuration. [Figure 46] FIG. 46 is a side view of a portion of the outer sleeve of FIG. 45 showing the hypotube in a 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 examples of the disclosure are described herein. The disclosed methods, apparatus, 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 and in various combinations and subcombinations with each other. The methods, apparatus, and systems are not limited to any particular aspect or feature, or combination thereof, nor do the disclosed embodiments require that any one or more particular advantages exist or problems be solved.

[0020] Although operations in some disclosed examples are described in a particular sequential order for convenience of presentation, it should be understood that aspects of the description encompass permutations unless a particular order is required by specific language set forth below. For example, operations described sequentially may be permuted in some cases and may be performed simultaneously. Moreover, for simplicity, the accompanying drawings may not show various aspects 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] All features described herein are independent of one another and may be used in combination with any other feature described herein, unless structurally impossible. For example, the delivery device 100 as shown in Figure 2 may be used in combination with the prosthetic valves 200 or 400 described herein. In another embodiment, the actuator mechanism 206 shown in Figure 3 may be used in combination with the prosthetic valve 400 shown in Figure 12 and / or the prosthetic valve 10 shown in Figure 1.

[0022] As used in this application and the claims, the singular forms "a," "an," and "the" include the plural unless the context clearly dictates otherwise. Additionally, the term "includes" means "comprises." Furthermore, the term "coupled" generally means to physically, mechanically, chemically, magnetically, and / or electrically connect or link, and does not exclude the presence of intermediate elements between connected or associated members, unless specifically stated to the contrary.

[0023] As used herein, the term "proximal" refers to a position, direction, 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, direction, 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 the movement of the device away from the implantation site and toward the user (e.g., out of the patient's body), while distal movement of a device is the movement of the device away from the user and toward the implantation site (e.g., into the patient's body). The terms "longitudinal" and "axial" refer to axes extending in the proximal and distal directions, unless expressly defined otherwise.

[0024] As used herein, "eg" means "for example," and "ie" means "that is."

[0025] Examples of the disclosed technology Described herein are examples of prosthetic implants, such as prosthetic heart valves, that may be implanted into any native valve in the heart (e.g., aortic, mitral, tricuspid, and pulmonary valves). The present disclosure also provides a frame for use with such prosthetic implants. The frame may further include an actuator mechanism (e.g., an expansion mechanism) and / or a locking mechanism to provide greater control over the radial compression or radial expansion of the valve body. The frame may include struts having different shapes and / or sizes, which may minimize the overall crimping profile of the implant while providing sufficient structural strength and rigidity in the areas where it is needed.

[0026] The prosthetic valves disclosed herein can be radially compressible and radially expandable between a radially compressed state and a radially expanded state. Thus, the prosthetic valve can be crimped or held by an implant delivery device in a radially compressed state during delivery, and then expanded to a radially expanded state after the prosthetic valve reaches the implantation site. It is understood that the valves disclosed herein can be used with a variety of implant delivery devices, examples of which are described in more detail below.

[0027] 1 illustrates an exemplary prosthetic valve 10, according to one embodiment. The prosthetic valve 10 may include an annular stent or frame 12 having an inflow end 14 and an outflow end 16. The prosthetic valve 10 may also include a valvular structure 18 coupled to and supported on the interior of the frame 12. The valvular structure 18 is configured to regulate the flow of blood through the prosthetic valve 10 from the inflow end 14 to the outflow end 16.

[0028] The valve structure 18 may include a leaflet assembly comprising one or more leaflets 20 made, for example, of a flexible material. The leaflets 20 may be made, in whole or in part, of a biological material, a biocompatible synthetic material, or other such material. Suitable biological materials may include, for example, bovine pericardium (or pericardium from other sources). The leaflets 20 may be secured to one another at their adjacent sides to form commissures, each of which may be secured to a respective actuator mechanism 50 or frame 12.

[0029] In the illustrated example, the valve structure 18 may include three leaflets 20 arranged to be folded in a tricuspid configuration. Each leaflet 20 may have an inflow edge 22. As shown in FIG. 1, the inflow edge 22 of the leaflets 20 may define an undulating, curved, scalloped shape that circumferentially follows or tracks the multiple interconnected strut segments of the frame 12 when the frame 12 is in a radially expanded configuration. The inflow edge of the leaflets may be referred to as a "scallop line."

[0030] In some embodiments, the inflow edge 22 of the leaflets 20 may be sutured to the adjacent struts of the frame generally along the scallop line. In some embodiments, the inflow edge 22 of the leaflets 20 may be sutured to the inner skirt, which is then sutured to the adjacent struts of the frame. Forming the leaflets 20 in such a scalloped shape reduces stress on the leaflets 20, thereby improving the durability of the valve 10. Additionally, the scalloped shape may eliminate or at least minimize bending and waviness in the abdomen (the central region of each leaflet) of each leaflet 20, which can cause premature calcification in those regions. The scalloped shape also reduces the amount of tissue material used to form the valve structure 18, thereby allowing for a smaller, more uniform crimp profile at the inflow end 14 of the valve 10.

[0031] Further details regarding transcatheter prosthetic heart valves, including the manner in which the valve structure may be attached to the frame of the prosthetic valve, can be found, for example, in U.S. Pat. Nos. 6,730,118, 7,393,360, 7,510,575, 7,993,394, 8,252,202, and 11,135,056, and International Application No. PCT / US2020 / 024559, all of which are incorporated by reference in their entireties herein.

[0032] The prosthetic valve 10 may be radially compressible and expandable between a radially compressed configuration and a radially expanded configuration. The frame 12 may include a plurality of interconnected lattice struts 24 arranged in a lattice-type pattern forming a plurality of apexes 34 at the outflow end 16 of the prosthetic valve 10. The struts 24 may also form similar apexes 32 at the inflow end 14 of the prosthetic valve 10.

[0033] The struts 24 may be pivotally coupled to one another at one or more pivot joints or junctions 28 along the length of each strut. For example, in one embodiment, each of the struts 24 may be formed with openings 30 at opposing ends of the strut, the openings being spaced along the length of the strut. A hinge may be formed at each of the struts 24 where they overlap one another via fasteners 38, e.g., rivets or pins, that extend through the openings 30. The hinges may allow the struts 24 to pivot relative to one another when the frame 12 is radially expanded or compressed, such as during assembly, preparation, or implantation of the prosthetic valve 10.

[0034] The components used to form the frame struts and pivot joints of frame 12 (or any of the frames described below) may be made of any of a variety of suitable materials, such as stainless steel, cobalt chromium alloy, or nickel titanium alloy ("NiTi"), e.g., Nitinol. In some embodiments, frame 12 may be constructed by forming the individual components (e.g., the frame struts and fasteners) and then mechanically assembling and connecting the individual components together. Further details regarding the construction of frames and prosthetic valves are described in U.S. Patent Nos. 10,806,573, 10,603,165, 10,869,759, and 11,446,141, all of which are incorporated herein by reference in their entireties.

[0035] In the illustrated example, the prosthetic valve 10 may be mechanically expanded from a radially contracted configuration to a radially expanded configuration. For example, the prosthetic valve 10 may be radially expanded by maintaining the inflow end 14 of the frame 12 in a fixed position while applying an axial force to the outflow end 16 toward the inflow end 14. Alternatively, the prosthetic valve 10 may be expanded by applying an axial force to the inflow end 14 while maintaining the outflow end 16 in a fixed position, or by applying opposing axial forces to the inflow and outflow ends 14, 16, respectively.

[0036] 1, the prosthetic valve 10 may include one or more actuators 50 attached to an inner surface of and evenly spaced about the periphery of the frame 12. Each of the actuators 50 may be configured to form a releasable connection with one or more respective actuators of a delivery device.

[0037] In the illustrated embodiment, the expansion and compression forces may be applied to the frame by actuators 50. Each of the actuators 50 may include a screw / actuation bolt / threaded rod 52, a first anchor in the form of a cylinder or sleeve 54, and a second anchor in the form of a threaded nut 56. The rod 52 extends through the sleeve 54 and the nut 56. The sleeve 54 may be secured to the frame 12, such as with a fastener 38 that forms a hinge at the joint between the two posts. Each actuator 50 is configured to increase the distance between the mounting locations of the respective sleeve 54 and nut 56, thereby causing the frame 12 to stretch axially and compress radially, and to decrease the distance between the mounting locations of the respective sleeve 54 and nut 56, thereby causing the frame 12 to shorten axially and expand radially.

[0038] For example, each rod 52 may have external threads that engage internal threads of a nut 56 such that rotation of the rod causes corresponding axial movement of the nut 56 toward or away from the sleeve 54 (depending on the direction of rotation of the rod 52). This causes the hinges supporting the sleeve 54 and nut 56 to move closer toward each other, causing the frame to radially expand, or move further away from each other, causing the frame to radially compress, depending on the direction of rotation of the rod 52.

[0039] In some embodiments, the actuators 50 may be reciprocating type actuators configured to apply an axial force to the frame to generate radial expansion and compression of the frame. For example, the rod 52 of each actuator may be axially fixed relative to the nut 56 and slidable relative to the sleeve 54. Thus, in this manner, moving the rod 52 distally relative to the sleeve 54 and / or moving the sleeve 54 proximally relative to the rod 52 radially compresses the frame. Conversely, moving the rod 52 proximally relative to the sleeve 54 and / or moving the sleeve 54 distally relative to the rod 52 radially expands the frame.

[0040] When using a reciprocating type actuator, the prosthetic valve may also include one or more locking mechanisms that hold the frame in the expanded state. The locking mechanisms may be separate components mounted on the frame separately from the actuator, or may be subcomponents of the actuator itself.

[0041] Each rod 52 may include an attachment member 58 along a proximal end portion of the rod 52 that is configured to form a releasable connection with a corresponding actuator of the delivery device. The actuator(s) of the delivery device may apply a force to the rod to radially compress or expand the prosthetic valve 10. In the illustrated configuration, the attachment member 58 includes a notch 60 and a protrusion 62 that may engage with a corresponding protrusion of the actuator of the delivery device.

[0042] In the illustrated embodiment, the prosthetic valve 10 includes three such actuators 50, although in other embodiments, a greater or lesser number of actuators may be used. The leaflets 20 may have commissure attachment members 64 that wrap around the sleeve 54 of the actuator 50. Further details of the actuators, locking mechanisms, and delivery devices for actuating the actuators can be found in U.S. Pat. Nos. 10,603,165 and 10,806,573, and 11,135,056, U.S. Publication No. 2022 / 0257367, and International Publication No. PCT / US2021 / 022467, each of which is incorporated herein by reference in its entirety. Any of the actuators and locking mechanisms disclosed in the previously filed applications may be incorporated into any of the prosthetic valves disclosed herein. Additionally, any of the delivery devices disclosed in the previously filed applications may be used to deliver and implant any of the prosthetic valves disclosed herein.

[0043] The prosthetic valve 10 may include one or more skirts or sealing members. In some embodiments, the prosthetic valve 10 may include an inner skirt (not shown) mounted on the inner surface of the frame. The inner skirt may function as a sealing member to prevent or reduce paravalvular leakage, secure the leaflets to the frame, and / or protect the leaflets from damage caused by contact with the frame during crimping and during the work cycle of the prosthetic valve. As shown in FIG. 1, the prosthetic valve 10 may also include an outer skirt 70 mounted on the outer surface of the frame 12. The outer skirt 70 may function as a sealing member for the prosthetic valve by sealing against the tissue of the native annulus and helping to reduce paravalvular leakage through the prosthetic valve. The inner and outer skirts may be formed from any of a variety of suitable biocompatible materials, including any of a variety of synthetic materials, including textiles (e.g., polyethylene terephthalate textiles), or autologous tissue (e.g., pericardial tissue). Further details regarding the use of skirts or sealing members in prosthetic valves can be found, for example, in US Pat. No. 11,399,932, which is incorporated herein by reference in its entirety.

[0044] 2 illustrates a delivery device 100 adapted to deliver a prosthetic heart valve 102, such as the illustrated prosthetic heart valve 10 described above, according to one embodiment. The prosthetic valve 102 can be removably coupled to the delivery device 100. It should be understood that the delivery device 100 and other delivery devices disclosed herein may be used to implant prosthetic devices other than prosthetic valves, such as stents or grafts.

[0045] The delivery device 100 of the illustrated embodiment generally includes a handle 104, a first elongated shaft 106 (which in the illustrated embodiment comprises an outer shaft) extending distally from the handle 104, and at least one actuator assembly 108 extending distally through the outer shaft 106. The at least one actuator assembly 108 can be configured to radially expand and / or radially collapse the prosthetic valve 102 when actuated.

[0046] While the illustrated embodiment shows two actuator assemblies 108 for illustrative purposes, it should be understood that one actuator 108 may be provided for each actuator on the prosthetic valve. For example, three actuator assemblies 108 may be provided for a prosthetic valve having three actuators. In some embodiments, there may be a greater or lesser number of actuator assemblies.

[0047] In some embodiments, the distal end portion 116 of the shaft 106 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 portion 116 acts as a delivery sheath or capsule for the prosthetic valve during delivery.

[0048] The actuator assemblies 108 can be releasably coupled to the prosthetic valve 102. For example, in the illustrated embodiment, each actuator assembly 108 can be coupled to a respective actuator of the prosthetic valve 102. Each actuator assembly 108 can include a support tube, an actuator member, and a locking tool. When actuated, the actuator assembly can 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 108 can be at least partially radially disposed within and extend axially through one or more lumens of the outer shaft 106. For example, the actuator assemblies 108 can extend through a central lumen of the shaft 106 or through separate respective lumens formed within the shaft 106.

[0049] The handle 104 of the delivery device 100 may include one or more control mechanisms (e.g., knobs or other actuation mechanisms) for controlling different components of the delivery device 100 to expand and / or deploy the prosthetic valve 102. For example, in the illustrated embodiment, the handle 104 includes first, second, and third knobs 110, 112, and 114.

[0050] The first knob 110 may be a rotatable knob configured to generate axial movement of the outer shaft 106 in a distal and / or proximal direction relative to the prosthetic valve 102 to deploy the prosthetic valve from the delivery sheath 116 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 110 in a first direction (e.g., clockwise) can retract the sheath 116 proximally relative to the prosthetic valve 102, and rotation of the first knob 110 in a second direction (e.g., counterclockwise) can advance the sheath 116 distally. In some examples, the first knob 110 may be actuated by sliding or moving the knob 110 axially, such as by pulling and / or pushing the knob. In some embodiments, actuation of the first knob 110 (rotation or sliding movement of the knob 110) can generate axial movement of the actuator assembly 108 (and thus the prosthetic valve 102) relative to the delivery sheath 116 to advance the prosthetic valve distally from the sheath 116.

[0051] The second knob 112 may be a rotatable knob configured to generate radial expansion and / or contraction of the prosthetic valve 102. For example, rotation of the second knob 112 may move the actuator member and the support tube axially relative to one another. Rotation of the second knob 112 in a first direction (e.g., clockwise) may cause the prosthetic valve 102 to radially expand, and rotation of the second knob 112 in a second direction (e.g., counterclockwise) may cause the prosthetic valve 102 to radially collapse. In some examples, the second knob 112 may be actuated by sliding or moving the knob 112 axially, such as by pulling and / or pushing the knob.

[0052] The third knob 114 may be a rotatable knob configured to hold the prosthetic heart valve 102 in its expanded configuration. For example, the third knob 114 may be operatively connected to a proximal end portion of a locking tool of each actuator assembly 108. Rotation of the third knob in a first direction (e.g., clockwise) may rotate the locking tools to advance the locking nuts to their distal positions to resist radial compression of the frame of the prosthetic valve, as described above. Rotating the knob 114 in the opposite direction (e.g., counterclockwise) may rotate the locking tools in the opposite direction to uncouple the locking tools from the prosthetic valve 102. In some examples, the third knob 114 may be actuated by sliding or moving the third knob 114 axially, such as by pulling and / or pushing the knob.

[0053] Although not shown, the handle 104 can include a fourth rotatable knob operably connected to the proximal end portion of each actuator member. The fourth knob can be configured to rotate each actuator member when the knob is rotationally actuated, thereby unscrewing each actuator member from the proximal portion of its respective actuator. As described above, the locking tool and actuator members can be removed from the patient after being uncoupled from the prosthetic valve 102.

[0054] 3 shows an illustrative example of a prosthetic heart valve 200 comprising a single lattice frame 202. The prosthetic valve 200 may include a valve structure including multiple leaflets (such as a valve structure 18 including leaflets 20) and inner and / or outer skirts, as previously described, although these components are omitted for purposes of illustration. The frame 202 may include one or more axially extending struts or posts 204, one or more of which may be configured as an integral expansion and locking mechanism or actuator mechanism 206 comprising an actuator 234 (such as a threaded rod) and first and second actuator struts / posts 222, 224.

[0055] FIG. 3 illustrates the frame 202 in a partially expanded configuration and shows the frame 202 coupled to an actuator assembly 300 of a delivery device (eg, delivery device 100).

[0056] The frame 202 may have an inflow end portion 208 (which in the delivery configuration of the illustrated embodiment is the distal end of the frame) and an outflow end portion 210 (which in the delivery configuration of the illustrated embodiment is the proximal end portion of the frame).

[0057] As described above, the frame 202 may include a number of axially extending struts or posts 204, one or more of which may be configured as an actuator mechanism 206. The actuator mechanism 206 may include a number of first actuator struts or posts 222 (which may be lower posts in the illustrated embodiment and may extend to the inflow end of the frame) and a number of second actuator struts or posts 224 (which may be upper posts in the illustrated embodiment and may extend to the outflow end of the frame). Each first actuator post 222 may be axially aligned with a corresponding second actuator post 224, thereby defining a pair of a first post and a second post. One or more pairs of actuator posts 222, 224 may be configured as part of the actuator mechanism 206. The actuator posts 204 may be connected together by a number of link members or posts 212. For example, in the illustrated embodiment, the posts 212 define a number of cells extending circumferentially around the frame 202. The circumferentially extending cells may include relatively large hexagonal cells 214 and relatively small diamond shaped cells 216 disposed within the hexagonal cells 214. However, in some embodiments, the cells may have any of a variety of other shapes, e.g., triangular, teardrop shaped, rectangular, square, oval, square oval, etc. For example, as described in more detail below, FIG. 13 illustrates another embodiment of a prosthetic heart valve 400 including a frame 402 having a plurality of axially extending struts or posts 404 connected together by a plurality of curved link members or struts 412.

[0058] Each hexagonal cell 214 is formed by two upper struts 252a, 252b, two lower struts 254a, 254b, and two axial struts 256, 258, each extending between and connecting the ends of the upper struts 252a, 252b and the lower struts 254a, 254b, respectively. The upper struts 252a, 252b may be part of an upper row of struts defining the outflow end of the frame, and the lower struts 254a, 254b may be part of a lower row of struts defining the inflow end of the frame. Each diamond-shaped cell 216 is formed by two upper struts 260a, 260b and two lower struts 262a, 262b. The lower ends of the upper struts 260a, 260b and the upper ends of the lower struts 262a, 262b can be connected to the axial struts 256, 258. The upper ends of the upper struts 252a, 252b of each hexagonal cell 214 can be connected to the second post 224, and the upper ends of the upper struts 260a, 260b of the corresponding diamond-shaped cell 216 can be connected to the same second post 224. The lower ends of the lower struts 254a, 254b of each hexagonal cell 214 can be connected to the first post 222, and the lower ends of the lower struts 262a, 262b of the corresponding diamond-shaped cell 216 can be connected to the same first post 222.

[0059] In the illustrated embodiment, there is one row of hexagonal cells 214 and one row of diamond shaped cells 216. In an alternative embodiment, the frame 202 can include multiple rows of hexagonal cells 214 and multiple rows of diamond shaped cells 216 arranged along the length of the frame, with the diamond shaped cells 216 positioned within the hexagonal cells.

[0060] Each of the hexagonal and diamond cells 214, 216 may include a respective inlet apex 218 and outlet apex 220. Each pair of actuator posts 222, 224 may extend through and be coupled to the inlet and outlet apexes 218, 220 of a respective pair of hexagonal cells 214 and diamond cells 216. In the illustrated embodiment, the frame 202 is comprised of six hexagonal cells 214 extending in a circumferential row, with a diamond-shaped cell 216 within each hexagonal cell 214, and six pairs of actuator posts 222, 224 coupled to each pair of cells 214, 216. However, in some embodiments, the frame 202 may be configured with a greater or lesser number of hexagonal cells 214 in a row, and a greater or lesser number of corresponding diamond cells 216 and / or pairs of actuator posts 222, 224.

[0061] In some embodiments, each pair of actuator posts 222, 224 may comprise part of the actuator mechanism 206 in combination with the actuator / threaded rod 234. For example, in the illustrated embodiment, the frame includes six pairs of posts 222, 224, each of which is configured as part of the actuator mechanism 206. In some embodiments, the frame 202 may include a greater or lesser number of actuator posts, and not all pairs of posts 222, 224 need to be actuator posts. If a pair of posts 222, 224 is configured as part of an actuator mechanism, an actuator / screw / actuating bolt / threaded rod 234 extends through each of the pair of actuator posts 222, 224 to effect radial compression and expansion of the frame, as described further below. If a pair of posts 222, 224 is not configured as part of an actuator mechanism, the actuator / threaded rod 234 does not need to extend through that pair of posts 222, 224, and the posts 222, 224 do not need to include other features described below to radially compress and expand the frame.

[0062] In the depicted example, the actuator 234 is shown as a threaded rod, however, in some examples, the actuator may be any of a variety of members and / or mechanisms configured to axially move the first and second actuator posts 222, 224 relative to one another. For example, in some embodiments, the actuator 234 may be a linear rack including a plurality of teeth and configured to engage corresponding pawls on the first and / or second actuator posts, or vice versa.

[0063] The upper end of each first actuator post 222 and the lower end of the corresponding second actuator post 224 may be separated by a gap G, allowing the actuator posts 222, 224 to move toward and away from each other during radial expansion and radial compression of the frame, respectively. In the following description, the first and second actuator posts 222, 224 that are part of the actuator mechanism (i.e., those that include the threaded rod 234) may also be referred to as the first and second actuator frame members 222, 224, respectively, or more simply as the first and second frame members 222, 224.

[0064] Each actuator frame member 222, 224 can include an internal bore 232 (FIG. 11) extending along the length of the frame member 222, 224 through which a threaded rod 234 can extend. The outflow end portion 226 of the first frame member 222 can include or house a nut 228. In certain embodiments, the nut 228 can be formed separately from the frame member 222, which can be formed with a cutout area that defines a window 230 in the outflow end portion of the frame member. The nut 228 can be positioned or housed within the cutout area. As shown in FIG. 3, the nut 228 is visible through the window 230. The nut 228 can include an internal threaded bore configured to engage the threads of the threaded rod 234 such that rotation of the threaded rod 234 moves the first frame member 222 coupled to the nut 228 relative to the second frame member 224, which is held stationary.

[0065] In some examples, instead of using nuts 228, a portion of the inner bore 232 of the first frame member 222 may be threaded. For example, an outflow end portion of the first frame member 222 may comprise internal threads configured to engage with a threaded rod 234, such that rotation of the threaded rod moves the first frame member 222 relative to the second frame member 224. In some embodiments, the inner bore 232 of the first frame member 222 may be threaded along its entire length. In alternative embodiments, each second frame member 224 may have internal threads or may house a nut 228 that may engage with the external threads of the threaded rod 234.

[0066] Rotation of the threaded rod 234 in a first direction (e.g., clockwise) causes corresponding axial movement of the first and second frame members 222, 224 toward one another, expanding the frame 202, and rotation of the threaded rod 234 in a second direction (e.g., counterclockwise) causes corresponding axial movement of the first and second frame members 222, 224 away from one another, compressing the frame. As the frame 202 moves from the compressed configuration to the expanded configuration, a gap G between the first and second frame members 222, 224 of the actuator mechanism 206 can narrow. The threaded rod 234 can include a stopper 236 (such as in the form of a nut) disposed thereon. As shown in FIG. 3, the stopper 236 can be disposed on the threaded rod 234 such that it is located within the gap G. During crimping / compression of the prosthetic valve 200, the threaded rod 234 can be rotated in a second direction (e.g., counterclockwise) to move the stopper 236 toward the outflow end portion 210 of the frame 202 until it abuts the inflow edge of the second frame member 224, thereby preventing over-crimping of the frame 202.

[0067] 4, the outflow or proximal end portion 238 of each threaded rod 234 may include a head portion 240 configured to be removably coupled to a respective actuator assembly 300. The head portion 240 may include first and second protrusions 242 defining a channel or slot 244 therebetween and one or more shoulders 246. As shown in FIG. 11, the head portion 240 may have a width greater than a diameter of the inner bore 232 such that the head portion 240 is prevented from moving into the inner bore 232 of the second frame member 224 and the head portion 240 abuts the outflow end portion 210 of the frame 402. The head portion 240 may be used to apply a force in a distal direction to the second frame member 224, for example, during radial expansion of the frame 402.

[0068] Rotation of the threaded rod 234 while holding the second frame member 224 stable in a fixed position relative to the distal device and surrounding anatomy (e.g., using the actuator assembly 300 of the delivery device) or while applying a distally directed force to the second frame member 224 causes axial movement of the inflow and outflow ends 208, 210 relative to one another, causing radial expansion or compression of the frame 202. For example, moving the inflow and outflow ends 208, 210 toward one another causes the frame to shorten axially and expand radially. Conversely, moving the inflow and outflow ends 208, 210 away from one another causes the frame 202 to elongate axially and compress radially.

[0069] As shown in FIGS. 4-11, the threaded rod 234 of each actuator mechanism 206 may be removably coupled to a respective actuator assembly 300 of a delivery device, such as the delivery device 100 described above. With reference to FIG. 4, 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 transparently in FIGS. 4-6 and 9 for illustrative purposes. Distal end portions of the outer sleeve 302 and the driver 304 may be configured to engage or abut the proximal end (e.g., outflow end) of the threaded rod 234 and / or the frame 202. The proximal portions of the outer sleeve 302 and the driver 304 may be operably coupled to a handle (e.g., handle 104) of the delivery device. The delivery device of this example may include the same features previously described for the delivery device 100. In some examples, a proximal end portion of each driver 304 may be operably connected to knob 112 such that rotation (clockwise or counterclockwise) of knob 112 causes a corresponding rotation of driver 304. A proximal end portion of each outer sleeve 302 may be operably connected to knob 114 such that rotation (clockwise or counterclockwise) of knob 114 causes a corresponding axial movement (proximal or distal) of sleeve 302 relative to driver 304. In some examples, the handle may include an electric motor for actuating these components.

[0070] The distal end portion of the driver 304 may include one or more flexible elongated elements 308 including a central protrusion 306 configured to extend into the slot 244 of the threaded rod 234 and protrusions or teeth 310 configured to be releasably coupled to a shoulder 246 of the threaded rod 234. The protrusions 310 may extend radially inward toward a longitudinal axis of the driver / second actuation member 304. As shown in FIGS. 4-5 , the elongated elements 308 may be configured to be biased radially outward to an expanded state, for example, by shaping of the elements 308.

[0071] As shown in FIG. 5, to couple the actuator assembly 300 to the threaded rod 234, the driver 304 may be positioned such that the central projection 306 is disposed within the slot 244 (FIG. 4) and the projection 310 of the elongated element 308 is positioned distal to the shoulder 246. With reference to FIG. 6, as the outer sleeve 302 is advanced (e.g., distally) over the driver 304, the elongated element 308 is radially compressed until the projection 310 abuts the shoulder 246, thereby coupling the actuator assembly 300 to the threaded rod 234. The outer sleeve 302 may continue to be advanced until the outer sleeve 302 engages the frame 202, as shown in FIG. 8. The driver 304 may then be rotated (e.g., with the handle of the delivery device 100) to cause a corresponding rotation of the threaded rod 234. Central protrusion 306 may be configured (eg, sized and shaped) to be advantageously spaced from the inner wall of outer sleeve 302 such that central protrusion 306 does not come into frictional contact with outer sleeve 302 during rotation.

[0072] In the illustrated embodiment, central protrusion 306 has a substantially rectangular shape in cross section, however, in some embodiments, protrusion 306 can have any of a variety of shapes, e.g., square, triangular, oval, etc. Slot 244 can be correspondingly shaped to receive protrusion 306.

[0073] 7, the distal end portion of the outer sleeve 302 may be comprised of first and second support extensions 312 that define a gap or notch 314 between the extensions 312. As shown in FIG. 8, the support extensions 312 may be oriented such that when the actuator assembly 300 is coupled to the respective actuator mechanism 206, the support extensions 312 extend partially onto the proximal end portion (e.g., the upper end portion) of the second frame member 224, and in particular onto the radially outer surface 248 and the radially inner surface 250 of the second frame member 224. The engagement of the support extensions 312 with the frame 202 counteracts the rotational forces applied to the frame by the rods 234 as the frame expands. If no forces were acting to counter these rotational forces, the frame would tend to "jerk" or rock in the direction of the rotation of the rods when the rods are actuated to expand the frame. The illustrated configuration is advantageous in that when the outer sleeve engages the second frame member 224, such jerking or rocking of the frame as it is expanded can be prevented or mitigated.

[0074] The prosthetic valve 200, including one or more actuator mechanisms 206, may be expanded in the following exemplary manner. Generally, the prosthetic valve 200 is placed in a radially compressed state and releasably coupled to one or more actuator assemblies 300 of a delivery device (such as the delivery device 100 shown in FIG. 2) as described above, and the delivery device and prosthetic valve may be advanced over a guidewire through the patient's vasculature to a selected implantation site (e.g., the native aortic annulus). For example, if the prosthetic valve is to be implanted within a native aortic valve, the delivery device and prosthetic valve may be inserted into and through the femoral artery and through the aorta to the native aortic valve. The prosthetic valve 200 may then be deployed to the implantation site (e.g., within the native aortic valve) and expanded and locked in an expanded configuration using the actuator mechanism 206. Once a selected diameter of the prosthetic valve 200 is reached, the actuator assembly 300 may be decoupled from the actuator mechanism 206 and removed from the patient's body.

[0075] To deploy the prosthetic valve 200, the physician can actuate the actuator assembly 300 by rotating the driver 304 in a first direction (e.g., by rotating the knob 112 or by activating the motor), which can cause a corresponding rotation of the threaded rod 234. Rotation of the threaded rod 234 can cause axial movement of the actuator mechanism 206 of the first and second frame members 222, 224 toward one another, decreasing the distance between the frame members 222, 224 and causing the frame 202 to shorten axially and expand radially until a selected diameter is achieved. Embodiments of the disclosed actuator mechanism advantageously allow for continuous prosthetic valve expansion (e.g., without the stepped expansion resulting from a ratchet mechanism), allowing the prosthetic heart valve to be deployed at any of a variety of diameters.

[0076] When the prosthetic valve 200 is implanted at a selected implantation site within a patient, the patient's natural anatomy (e.g., the native aortic valve annulus) can exert radial forces against the prosthetic valve 200 that tend to compress the frame 202. However, engagement of the threaded rod 234 and the threaded nut 228 prevents such forces from compressing the frame 202, thereby ensuring that the frame remains locked in a desired radially expanded state.

[0077] When repositioning or recapturing and removal of the prosthetic valve 200 is desired, the prosthetic valve may be compressed (from an expanded or partially expanded configuration) by rotating the driver 304, and thus the threaded rod 234, in a second, opposite direction. Rotation of the threaded rod 234 may cause the actuator mechanism 206 to axially move the first and second frame members 222, 224 away from each other, increasing the distance between the frame members 222, 224 and causing the frame 202 to elongate axially and compress radially. Once the prosthetic valve 200 is recompressed, it may be repositioned at the implantation site, and once repositioned, it may be expanded as previously described. The prosthetic valve may be recompressed, repositioned, and reexpanded multiple times as needed. In some cases, the prosthetic valve 200 may be fully compressed and "recaptured," i.e., pulled back into the sheath and / or removed from the patient's body.

[0078] Once final positioning and expansion of the prosthetic valve has been achieved, the actuator assembly 300 may be released from the prosthetic valve 200 by retracting the sleeve 302 to expose the connection between the driver 304 and the rod 234. This may be accomplished by rotating the knob 114 or by activating a motor in the handle of the delivery device. As each sleeve 302 is retracted, the expandable element 308 of the driver 304 may expand outwardly and away from the shoulder 246 of the head portion 240 of the rod 234, thereby separating the driver 304 from the rod 234. At this stage, the delivery device (including all of the actuator assembly 300) may be retracted relative to the prosthetic valve 200 and removed from the patient's body.

[0079] 12 illustrates an example of a prosthetic valve 400 having a frame 402 that includes an inflow end portion 408 and an outflow end portion 410. The prosthetic valve 400 may further include a valve structure 454 coupled to and supported within the frame 402. The valve structure 454 is configured to regulate the flow of blood through the prosthetic valve 400 from the inflow end 408 to the outflow end 410.

[0080] The prosthetic valve 400 may be similar to the prosthetic valve 200 described above, including a frame 402 with a number of axially extending posts 404, one or more of which (in combination with an actuator 426, such as a threaded rod) may be configured as an actuator mechanism 406 coupled together via a number of link members or struts 412. The prosthetic valve 400 of this example may include the same features as described above for the prosthetic valve 200, and may be coupled to an actuator assembly 300 and expanded as described above for the prosthetic valve 200.

[0081] The valve structure 454 may include a leaflet assembly with one or more leaflets 456 made, for example, of a flexible material. The leaflets 456 may be made, in whole or in part, of a biological material, of a biocompatible synthetic material, or of other such materials. Suitable biological materials may include, for example, bovine pericardium (or pericardium from other sources). The leaflets 456 may be secured to each other on adjacent sides to form commissures 458, and each commissure 458 may be secured to a respective post 404 (e.g., support post 407) or frame 402.

[0082] In the illustrated example, the valve structure 454 includes three leaflets 456 that may be configured to collapse in a tricuspid arrangement. Each leaflet 456 may have an inflow edge 460. As shown in FIG. 12 , the inflow edges 460 of the leaflets 456 may define an undulating, curved scalloped edge that follows or tracks portions of the struts 412 of the frame 402 in a circumferential direction when the frame 402 is in a radially expanded configuration. The inflow edges 460 of the leaflets may be referred to as a "scallop line."

[0083] 12, the inflow edge 460 of the leaflet 456 may be sutured generally along the scallop line to an inner skirt 464. The inner skirt 464 may then be sutured to adjacent struts 412 of the frame 402, for example, via one or more sutures 462. In some embodiments, the leaflet 456 may be sutured directly to the frame 402 along the scallop line.

[0084] The prosthetic valve 400 may further include one or more skirts or sealing members. For example, as previously described, the prosthetic valve 400 may include an inner skirt 464 attached to a radially inner surface of the frame 402. The inner skirt 464 may function as a sealing member to prevent or reduce paravalvular leakage, secure the leaflets to the frame, and / or protect the leaflets from damage caused by contact with the frame during crimping and during the work cycle of the prosthetic valve. The prosthetic valve 400 may further include an outer skirt 466 attached to an outer surface of the frame 402. The outer skirt 466 may function as a sealing member for the prosthetic valve by sealing against the tissue of the native annulus, helping to reduce paravalvular leakage through the prosthetic valve. The inner and outer skirts 464, 466 may be formed from any of a variety of suitable biocompatible materials, including any of a variety of synthetic materials, including woven fabrics (e.g., woven polyethylene terephthalate fabrics) or natural tissues (e.g., pericardial tissue). Further details regarding the use of skirts or sealing members in prosthetic valves can be found, for example, in US patent application Ser. No. 62 / 854,702.

[0085] The prosthetic valve 400 may be radially expandable and compressible between a radially expanded configuration and a radially compressed configuration. Figure 13 shows the bare frame 402 of the prosthetic valve 400 (without leaflets or other components) for purposes of illustrating the configuration of the frame 402. Although only one side of the frame 402 is depicted in Figure 13, it should be understood that the frame 402 forms an annular structure with an opposite side substantially identical to the portion shown.

[0086] As shown in FIG. 13, the struts 412 of the frame 402 may define a curved shape. The struts 412 may define a plurality of first and second cells extending circumferentially around the frame 402. Each first cell 414 may have an axially extending elliptical shape including first and second vertices 416 (e.g., inflow vertex 416a and outflow vertex 416b) disposed at a major vertex of the ellipse. Each first cell 414 may further include a respective second cell 418 disposed within an outer periphery of the first cell 414. The second cells 418 may have a circumferentially extending elliptical shape including first and second vertices 420 (e.g., inflow vertex 420a and outflow vertex 420b) disposed at a minor vertex of the ellipse.

[0087] In some embodiments, such as the embodiment shown in FIG. 13, each strut 412 may have a recurved or S-shaped shape including a first upwardly curved portion 413 and a second downwardly curved portion 415 separated by an inflection point. The curved portion 413 has a convex curved surface facing the outflow end of the frame and a concave curved surface facing the inflow end of the frame, and the curved portion 415 has a concave curved surface facing the outflow end of the frame and a convex curved surface facing the inflow end of the frame. Each strut 412 may terminate at either end in an asymptotic manner relative to the post 404 (e.g., the support post 407 and / or the actuator mechanism 406) such that it is approximately parallel to a longitudinal axis extending through the inflow and outflow ends of the frame 402. The struts 412 may be positioned such that the upwardly curved portion 413 is disposed closer to the inflow end 408 of the frame 402 and the downwardly curved portion 415 is disposed closer to the outflow end 410.

[0088] As described above, the frame 402 may include a plurality of axially extending struts or posts 404, including a plurality of first actuator struts or posts 422 (which may be lower posts in the illustrated embodiment and may extend to the inflow end of the frame) and a plurality of second actuator struts or posts 424 (which may be upper posts in the illustrated embodiment and may extend to the outflow end of the frame). Each first actuator post 422 may be axially aligned with a corresponding second actuator post 424 for each pair of the first and second actuator posts. One or more pairs of actuator posts 422, 424 in combination with an actuator 426 (e.g., a threaded rod) may be configured as an actuator mechanism 406. The frame 402 may further include additional posts 404 configured as support posts 407. The support posts 407 may be disposed between each pair of adjacent circumferentially disposed first cells 414, and the actuator mechanism 406 may be disposed to extend through and be coupled to the vertices 416, 420 of the first and second cells. The posts 404 may be connected together via struts 412 .

[0089] Each first cell 414 is formed by two upper columns 468a, 468b and two lower columns 470a, 470b. Each upper and lower column 468, 470 is coupled at one end to the actuator mechanism 406 and at the other end to a support post 407. The upper columns 468a, 468b can be part of an upper row of columns that define the outflow end of the frame, and the lower columns 470a, 470b can be part of a lower row of columns that define the inflow end of the frame. Each second cell 418 is formed by two upper columns 472a, 472b and two lower columns 474a, 474b. The lower ends of the upper columns 472a, 472b and the upper ends of the lower columns 474a, 474b can be connected to the support post 407. The upper ends of the upper posts 472a, 472b and the lower ends of the lower posts 474a, 474b can be connected to respective actuator mechanisms 406. In the illustrated embodiment, the upper ends of the upper posts 472a, 472b can be connected to the second post 424 and the lower ends of the lower posts 474a, 474b can be connected to the first post 422.

[0090] As described above, each of the first and second cells 414, 418 may include an inflow apex 416a, 420a and an outflow apex 416b, 420b. Each pair of posts 422, 424 may extend through and be coupled to the inflow and outflow apexes 416, 420 of the respective first and second cell pairs. In the illustrated embodiment, the frame 402 includes six first cells 414 extending in a circumferential row, a second cell 418 within each first cell 414, and six pairs of posts 422, 424 coupled to each pair of cells 414, 418. However, in some embodiments, the frame 402 may be configured with a greater or lesser number of first cells 414 in a row and a greater or lesser number of corresponding second cells 418 and / or pairs of posts 422, 424.

[0091] In some embodiments, each pair of actuator posts 422, 424 may be configured as part of the actuator mechanism 406 in combination with an actuator 426 (e.g., a threaded rod). For example, in the illustrated embodiment, each of the six pairs of actuator posts 422, 424 is configured as part of the actuator mechanism 406 in combination with an actuator 426. In some embodiments, not all pairs of actuator posts 422, 424 need to be part of an actuator mechanism. If a pair of actuator posts 422, 424 is configured as part of an actuator mechanism, a screw / actuator bolt / threaded rod 426 (including a head portion 425) extends through each actuator post 422, 424 of the pair to effect radial compression and expansion of the frame, similar to the actuator mechanism 206 described above. If a pair of actuator posts 422, 424 is not used as an actuator mechanism, the actuator 426 does not need to extend through that pair of actuator posts 422, 424. In the following description, the first and second actuator posts 422, 424 used as an actuator mechanism (i.e., including actuator 426) may be referred to as first and second actuator frame members 422, 424, respectively, or more simply as first and second frame members 422, 424.

[0092] In the depicted example, the actuator 426 is shown as a threaded rod, however, in some examples, the actuator 426 can be any of a variety of members and / or mechanisms configured to axially move the first and second actuator posts 422, 424 relative to one another to expand and / or compress the frame 402. For example, in some embodiments, the actuator 426 can be a linear rack with a number of teeth configured to engage corresponding pawls on the first and / or second actuator posts, or vice versa.

[0093] In the illustrated embodiment, actuator mechanism 406 may function in the same manner as actuator mechanism 206 and may include a threaded nut 423 disposed at an outflow end portion of first frame member 422 configured to engage threaded rod 426. Nut 423 may be received within a passageway of second frame member 422 (e.g., disposed within window 427). As shown in FIGS. 12-13 , nut 423 may be sized to fill window 427 such that nut 423 is restricted from movement relative to second frame member 422.

[0094] Rotation of the threaded rod 426 in a first direction (e.g., clockwise) causes corresponding axial movement of the first and second frame members 422, 424 toward one another (as shown by arrow 428), expanding the frame 402, and rotation of the threaded rod 426 in a second direction (e.g., counterclockwise) causes corresponding axial movement of the first and second frame members 422, 424 away from one another (as shown by arrow 430), compressing the frame. As the frame 402 moves from the compressed to the expanded configuration, a gap G ( FIG. 13 ) between the first and second frame members 422, 424 of the actuator mechanism 406 can be narrowed.

[0095] The threaded rod 426 can include a stopper 432 (e.g., a nut) disposed thereon. The stopper 432 can be disposed on the threaded rod 426 such that it is located within the gap G. During crimping / compression of the prosthetic valve 400, the threaded rod 426 can be rotated in a second direction (e.g., counterclockwise) to move the stopper 432 toward the outflow end portion 434 of the frame 402 until it abuts the inflow edge of the second frame member 424.

[0096] Because the threaded rod 426 is fixed to the frame 402 at axially spaced locations (the inlet end 408 and the outlet end 410), rotating the threaded rod 426 causes the inlet end 436 and the outlet end 434 to move axially relative to one another, causing a radial expansion or compression of the frame 402. For example, moving the inlet end 436 and the outlet end 434 toward one another causes the frame 402 to shorten axially and expand radially. Conversely, moving the inlet end 436 and the outlet end 434 away from one another causes the frame 402 to elongate axially and compress radially.

[0097] As shown in FIG. 13, the support post 407 can extend longitudinally and can have an inflow end portion 438 and an outflow end portion 440. The outflow end portion 440 of one or more of the support posts 407 can include a commissure support member 442. The commissure support member 442 can be comprised of first and second commissure arms 444 defining a commissure opening 446 therebetween. The commissure opening 446 can extend radially through the thickness of the post 404 and can be configured to receive a portion of the valvular structure 454 (e.g., the commissure 458) to couple the valvular structure 454 to the frame 402. In the illustrated example, the commissure opening 446 has a substantially rectangular shape and extends to the outflow end of the post 404. However, in some examples, the commissure opening can have any of a variety of shapes (e.g., square, oval, square-oval, triangular, L-shaped, T-shaped, C-shaped, etc.). In some examples, the opening 446 can be completely surrounded by a post (e.g., not extending to the outflow edge) so that a portion of the valve structure can be slid radially (rather than axially) into the commissure opening 446. The outflow end of each commissure arm 444 can include teeth 448 that extend into the commissure opening 446. The teeth 448 can help retain the commissure 458 within the commissure opening. Each commissure 458 can be attached to a respective commissure support member 442, such as by inserting a pair of commissure tabs of adjacent leaflets through the opening 446 and suturing the commissure tabs to each other and / or to the arm 444.

[0098] The inlet end portion 438 of each support post 407 can define a cantilevered extension 450 that extends toward the inlet end portion 436 of the frame 402. The extension 450 can include an opening 452 that extends radially through the thickness of the extension. In some examples, the extension 450 can extend such that the inlet edge of the extension aligns or substantially aligns with the inlet edge of the frame 402. In use, the extension 450 can prevent or mitigate a portion of the outer skirt 466 from extending radially inward, thereby preventing or mitigating an obstruction to flow through the inlet end 436 caused by the outer skirt 466. The extension 450 can further function as a support to which portions of the inner and / or outer skirts 464, 466 can be joined. For example, a suture used to connect the inner and / or outer skirts can be wrapped around the extension 450 and / or extend through the opening 452. In some embodiments, the leaflet portion 460 of the leaflet 456 may be supported by the extension 450, or by selected ones of the extensions. For example, the leaflet portion 460 may be secured to the adjacent extension 450 with a suture, which may extend through the opening 452.

[0099] As mentioned above, Fig. 13 shows only one side of the frame 402. Although Fig. 13 shows only one support post 407 that defines a commissure support member 442, it should be noted that the frame 402 can define any number of support posts 407, any number of which can be configured as commissure support members 442. For example, the frame 402 can be defined as six support posts 407, three of which can be configured as commissure support members 442. In some instances, for example, the frame can include one, two, three, or four commissure support members.

[0100] The actuator mechanism 406 may be removably coupled to one or more actuator assemblies 300, as described above with respect to the prosthetic valve 200. So coupled, the prosthetic heart valve 400 may be deployed at a selected implantation site using the same methods as described above with respect to the prosthetic heart valve 200. The actuator assembly 300 may actuate the actuator mechanism 406 to expand and / or compress the frame 402.

[0101] Once the prosthetic valve 400 is implanted at a selected implantation site within a patient, the patient's native anatomy (e.g., the native aortic annulus) may exert radial forces on the prosthetic valve 400 that tend to compress the frame 402. However, the engagement of the threaded rod 426 with the threaded nut 423 of the first frame member 422 prevents such forces from compressing the frame 402, thereby ensuring that the frame remains locked in a desired radially expanded state.

[0102] If repositioning or recapturing and removal of the prosthetic valve 400 is desired, the prosthetic valve may be compressed (from an expanded or partially expanded configuration) by rotating the threaded rod 426 in a second, opposite direction (e.g., using the driver 304 of the actuator assembly 300). Rotation of the threaded rod 426 may cause axial movement of the first and second frame members 422, 424 of the posts away from each other, increasing the distance between the frame members 422, 424 and allowing the frame to elongate axially and compress radially. Once the prosthetic valve 400 is recompressed, it may be repositioned at the implantation site, and once repositioned, the prosthetic valve 400 may be expanded as previously described. The prosthetic valve may be recompressed, repositioned, and reexpanded multiple times as needed. In some cases, the prosthetic valve 400 may be fully compressed and "recaptured," i.e., pulled back into the sheath and / or removed from the patient's body.

[0103] In some embodiments, selected threaded rods 426 can be configured as "right-handed" rods and selected threaded rods 426 can be configured as "left-handed" rods. As used herein, the term "right-handed" rods refers to rods where rotation of the rod in a first direction (e.g., clockwise) results in expansion of the frame 402 and the term "left-handed" rods refers to rods where rotation of the rod in a second direction (e.g., counterclockwise) results in expansion of the frame 402. With reference to FIG. 14, the prosthetic valve 400 can include six actuator mechanisms 406, each including a threaded rod 426 (e.g., threaded rods 426a, 426b, 426c, 426d, 426e, and 426f).

[0104] In some examples, the right and left hand rods can be arranged in an alternating pattern around the circumference of the valve 400 such that rods 426a, 426c, and 426e are configured as right hand rods and rods 426b, 426d, and 426f are configured as left hand rods. During expansion of the frame 402, the right hand rods 426a, 426c, 426e can be rotated (e.g., using a mechanism in the handle of the delivery device) in a first direction (e.g., clockwise) and the left hand rods 426b, 426d, and 426f can be rotated in a second direction opposite the first direction (e.g., counterclockwise). During compression of the frame 402, the right hand rods 426a, 426c, 426e can be rotated in a second direction (e.g., counterclockwise) and the left hand rods 426b, 426d, 426f can be rotated in a first direction (e.g., clockwise). Applying opposing rotational forces to alternating rods 426 can help prevent or reduce jerking or rocking motion of the frame while it is being expanded or compressed.

[0105] In some embodiments, the right hand rods can be positioned along a first semicircular portion of the circumference of the frame 402, and the left hand rods can be positioned along a second semicircular portion of the circumference, such that rods 426a, 426b, and 426c are configured as right hand rods and rods 426d, 426e, and 426f are configured as left hand rods. During expansion of the frame 402, the right hand rods 426a, 426b, 426c can rotate in a first direction (e.g., clockwise) and the left hand rods 426d, 426e, 426f can rotate in a second opposite direction (e.g., counterclockwise). During compression of the frame 402, the right hand rods can rotate in a second direction (e.g., counterclockwise) and the left hand rods can rotate in a first direction (e.g., clockwise).

[0106] 15-28 show another embodiment of an actuator assembly 500 (see, e.g., FIG. 22) of a delivery device that may be used to expand and / or compress a prosthetic valve, such as, for example, any of the prosthetic valves disclosed herein. The actuator assembly 500 may be a component of a delivery device (such as the delivery device 100 described above) and may be configured to removably couple and actuate a respective actuator / screw / actuation bolt / threaded rod of a prosthetic valve, such as the threaded rod 504 of the actuator mechanism 506 partially shown in FIGS. 22-25. Although not fully shown, the actuator mechanism 506 may have first and second actuator posts / frame members (similar to the first and second frame members 422 and 424 of the prosthetic valve 400) separated by a gap through which the threaded rod 504 extends. The threaded rod 504 may be used in place of or in addition to the threaded rods 234 and / or 426 of the prosthetic valves 200 and 400. The delivery device may include multiple actuator assemblies 500, one for each threaded rod 504 of the prosthetic valve.

[0107] 15-17, threaded rod 504 can include an elongated body 508 having a threaded portion 510, a non-threaded portion 511, and a head portion 512 configured to be removably coupled to a respective actuator assembly 500. In some embodiments, such as the illustrated embodiment, threaded rod 504 can include an annular notch 514 formed in non-threaded portion 511. In some embodiments, notch 514 can accommodate a stopper, such as stopper 432 described above, that can be swaged onto rod 504. In some embodiments, threaded rod 504 can be formed without notch 514. In such embodiments, the stopper can be welded to rod 504 at a selected location.

[0108] 27, the head portion 512 can have a diameter D1 that is greater than a diameter D2 of the inner bore 516 of the frame 502 of the prosthetic valve such that the head portion 512 is prevented from moving into the inner bore 516 of the frame 502 and the head portion 512 abuts the outflow edge 518 of the frame 502, as shown in FIG. 28, for example. The head portion 512 of the threaded rod 504 can be used to apply a distally directed force to the frame 502, for example, during radial expansion of the frame 502. The frame 502 can have the same configuration as the frame 402.

[0109] The head portion 512 can include a central recess 520 and one or more protrusions 522 disposed about the circumference of the head portion 512. In the illustrated example, the protrusions 522 can include a substantially semicircular shape in cross section, as shown in FIG. 17. In some examples, the protrusions 522 can have any of a variety of other cross-sectional shapes, such as a square, rectangular, triangular, etc. Although the illustrated embodiment shows four protrusions 522, in some embodiments, the head portion 512 can have any number of protrusions, e.g., one, two, three, four, five, six, seven, eight, etc. In the illustrated embodiment, the central recess 520 is configured as a square recess with rounded corners, although in some embodiments, the central recess 520 can have any of a variety of other shapes, such as a rectangle, an oval, a triangle, etc.

[0110] Rotation of the threaded rod 504 while stably holding the outflow end of the frame 502 in a fixed position relative to the distal end portion of the delivery device and the surrounding anatomical structures (e.g., using the actuator assembly 500 of the delivery device) or while applying a distally directed force to the frame 502 causes axial movement of the inflow and outflow ends of the frame 502 relative to one another to cause radial expansion or compression of the frame. For example, moving the inflow and outflow ends toward one another causes the frame 502 to shorten axially and expand radially. Conversely, moving the inflow and outflow ends away from one another causes the frame 502 to elongate axially and compress radially.

[0111] 18-21, each actuation assembly 500 can include a first actuation member configured as a support tube or outer sleeve 524 (FIG. 18) and a second actuation member configured as a driver 526 (FIG. 19). As best seen in FIG. 26, the driver 526 can extend through the outer sleeve / support tube 524. Distal end portions of the outer sleeve 524 and the driver 526 can be configured to engage or abut an outflow end portion 528 (FIG. 15) of the threaded rod 504 and / or an outflow end portion 530 of the frame 502. Proximal portions of the outer sleeve 524 and the driver 526 can be operably coupled to a handle of a delivery device (e.g., handle 104 of the delivery device 100). The delivery device of this example can include the same features described above for the delivery device 100. In some examples, a proximal end portion of each driver 526 may be operably connected to knob 112 such that rotation (clockwise or counterclockwise) of knob 112 causes a corresponding rotation of driver 526. A proximal end portion of each outer sleeve 524 may be operably connected to knob 114 such that rotation (clockwise or counterclockwise) of knob 114 causes a corresponding axial movement (proximal or distal) of sleeve 524 relative to driver 526. In some examples, the handle may include an electric motor for actuating these components.

[0112] 18, the first or distal end portion 532 of the outer sleeve 524 may be comprised of first and second support extensions 534 that define a gap or notch 535 therebetween. As shown in FIG. 22, the support extensions 534 may be oriented such that when the actuator assembly 500 is coupled to the respective actuators 506 of the frame 502, the support extensions 534 extend partially over an outflow end portion (e.g., top end portion) of the frame 502, such as the outflow apex or strut portion, and in particular over a radially outer surface 536 and a radially inner surface 538 of the outflow apex and the vertical strut extending from the apex. The engagement of the support extensions 534 with the frame 502 counteracts the rotational forces applied to the frame by the rods 504 during expansion of the frame 502. If no forces were acting to counter these rotational forces, the frame would tend to "jerk" or rock in the direction of the rotation of the rods when the rods are actuated to expand the frame. The illustrated configuration is advantageous in that the outer sleeve 524, when engaged with the actuator mechanism 506, can prevent or mitigate such jerking or rocking motion of the frame as it is expanded.

[0113] 18, the distal end portion 532 of the outer sleeve 524 may comprise a different material and / or construction than the elongated body 537. For example, in some embodiments, the distal end portion 532 may be a laser cut tube formed of a nickel-cobalt based alloy, such as MP35N Alloy®, and the elongated body 537 may be stainless steel. In some embodiments, the elongated body 537 may be a hollow torque cable. In some embodiments, the elongated body 537 may be a laser cut slotted hypotube.

[0114] 19, the driver 526 can include an elongated body 540 and an engagement portion 542 disposed at a distal end portion of the elongated body 540. In some embodiments, the elongated body 540 can include a cable, such as a 0.85 mm cable. In some embodiments, the elongated body 540 can be, for example, a slotted hypotube. The engagement portion 542 can include a driver head 544 and a gripper member 546. As shown in the illustrated embodiment, the driver head 544 can be coupled to the elongated body using, for example, a fastener 548. In some embodiments, the driver head 544 can be welded or otherwise permanently coupled to the elongated body 540. In some embodiments, the driver head 544 and the elongated body 540 can be integrally formed with one another.

[0115] In some embodiments, the gripper member 546 may be coupled to the elongated body 540 by sandwiching an annular base 560 of the gripper member 546 between the second end 554 of the driver head 544 and the fastener 548. The fastener 548 may then be welded to the driver head 544, capturing the annular base 560 therebetween such that the gripper member is restrained from axial movement relative to the driver head 544. In some embodiments, the gripper member 546 may be integrally formed with the fastener 548 or may otherwise be coupled to the fastener 548, such as via welding. In some embodiments, the elongated body 540, the driver head 544, and the gripper member 546 may be welded together, while in some embodiments, they may be coupled together using a swage coupling.

[0116] 20, the driver head 544 may include a body 550 having a first end 552 and a second end 554, an engagement member 556, and one or more extension members / protrusions 558. The one or more protrusions 558 may extend radially outward from the body 550 and may be spaced apart from one another around the circumference of the driver head 544. The engagement member 556 may extend distally from the first end 552 of the body 550 and may be configured to engage with a recess 520 of the respective threaded rod 504. In the illustrated embodiment, the engagement member 556 has a square shape with chamfered edges in cross section, however, in some embodiments, the engagement member 556 may have any of a variety of shapes, e.g., rectangular, triangular, oval, etc. The recess 520 of the head portion 512 of the threaded rod 504 may be correspondingly shaped to receive the engagement member 556. The shape of the engagement member 556 and the corresponding recess 520 may advantageously improve torque transmission from the driver 526 to the threaded rod 504 .

[0117] 26, a first end portion 552 of the driver head 544 may have a first diameter D3 and a second end portion 554 may have a second, smaller diameter D4. The second end 554 may extend into the fastener 548 to couple the driver head 544 to the elongated body 540. In some embodiments, the driver head 544 may include a nickel-cobalt based alloy, such as MP35N Alloy®.

[0118] 21, gripper member 546 may include an annular base member 560 and one or more extension members / wings / arms 562. Arms 562 may extend distally from base member 560 and may be resilient so as to be movable between an expanded position (FIG. 19) and a compressed position (FIG. 23). Arms 562 may be configured to be biased radially outward (e.g., away from the longitudinal axis of driver 526) into an expanded configuration, for example, by shaping arms 562. Each arm 562 may include a first elongated opening 564 and a second opening 566. In the illustrated example, gripper member 546 includes four arms, however, in some examples gripper member 546 may include any number of arms, e.g., one, two, three, four, five, six, seven, eight, etc. In some embodiments, gripper member 546 may include a laser cut Nitinol tube that may be heat set so that arms 562 are biased radially outward.

[0119] 19, the protrusion 558 of the driver head 544 can extend into the first opening 564 to restrain the gripper member 546 against axial and rotational movement relative to the driver head 544. The second opening 566 can be configured (e.g., sized and shaped) to engage with a protrusion 522 disposed on the head portion 512 of the respective threaded rod 504 to thereby removably couple the actuation assembly 500 to the threaded rod 504. In the illustrated embodiment, the first opening 564 is an elongated rectangular opening and the second opening 566 is a substantially square opening, although in some embodiments the openings 564, 566 can have any of a variety of shapes corresponding to the shapes and sizes of the protrusion 558 of the driver head 544 and the protrusion 522 of the threaded rod 504, respectively.

[0120] The actuator assembly 500 can couple the actuator mechanisms 506 of each of the prosthetic valves as follows: The engagement members 556 of the driver 526 can be disposed within the recesses 520 of the head portion 512 of the threaded rod 504 such that the second openings 566 of the gripper member arms 562 are disposed adjacent to the projections 522. As the outer sleeve 524 is advanced (e.g., distally) over the driver 526, the arms 562 are radially compressed until the projections 522 are disposed within the second openings 566, thereby coupling the actuator assembly 500 to the threaded rod 504 (e.g., as shown in FIG. 26 ). The outer sleeve 524 can continue to be advanced until the support extensions 534 engage the radially inner and outer surfaces 536, 538 of the frame 502, as shown in FIG. 22 . Once so coupled, the driver 526 can be rotated (e.g., with the handle of the delivery device 100) to cause a corresponding rotation of the threaded rod 504. The engagement between the actuator assembly 500 and the threaded rod 504 can advantageously improve torque transfer between the driver and the threaded rod 504 .

[0121] Generally, the prosthetic valve is placed in a radially compressed state, and the actuator mechanism 506 of the prosthetic valve is removably coupled to one or more actuator assemblies 500 in the manner previously described, as shown in Figures 22 and 26. The delivery device and prosthetic valve may be advanced over a guidewire through the patient's vasculature to a selected implantation site (e.g., the native aortic valve annulus). For example, if the prosthetic valve is to be implanted within a native aortic valve, the delivery device and prosthetic valve may be inserted into and through the femoral artery and through the aorta to the native aortic valve. The prosthetic valve may then be deployed at the implantation site (e.g., within the native aortic valve) and expanded and locked in the expanded configuration using the actuator mechanism 506.

[0122] To deploy the prosthetic valve, the physician can actuate the actuator mechanism 506 by rotating the driver 526 in a first direction (e.g., by rotating the knob 112 or by activating a motor), which causes a corresponding rotation of the threaded rod 504. Rotation of the threaded rod 504 in the first direction causes axial movement of the first and second frame members of the actuator mechanism (e.g., similar to the first and second frame members 422 and 424 of the prosthetic valve 400) toward one another, causing the frame 502 to shorten axially and expand radially until a selected diameter is achieved. Embodiments of the disclosed actuator mechanism advantageously allow for continuous prosthetic valve expansion (e.g., without the stepped expansion resulting from a ratchet mechanism), allowing the prosthetic heart valve to be deployed at any of a variety of diameters.

[0123] 22-28, once final positioning and expansion of the prosthetic valve has been achieved, the actuator assembly 500 may be released from the prosthetic valve in the following exemplary manner. The outer sleeve 524 may be retracted to expose the connection between the driver 526 and the threaded rod 504, as shown in FIGS. 23 and 27. This may be accomplished by rotating the knob 114 or by activating a motor in the handle of the delivery device 100. As shown in FIGS. 24 and 27, once the outer sleeve 524 is retracted, the arms 562 of the gripper members 546 may extend radially outwardly away from the head portion 512 of the threaded rod 504. As shown in FIGS. 25 and 28, the driver 526 may then be retracted and the engagement members 556 removed from within the recesses 520 of the rod 504, thereby separating the driver 526 from the rod 504. At this stage, the delivery device (including the actuator assembly 500) may be retracted relative to the prosthetic valve and removed from the patient's body.

[0124] 29-35 show another example of an actuator assembly 600 of a delivery device that may be used to radially expand and / or compress a prosthetic valve. Although FIG. 29 shows the actuator assembly 600 used on an exemplary frame 700 of a prosthetic valve, the actuator assembly 600 may be used on any of the prosthetic valves described herein and / or other prosthetic valves having similar expansion mechanisms. Although only one side of the frame 700 is shown in FIG. 29, it should be understood that the frame 700 forms an annular structure with an opposite side substantially identical to that shown. Additionally, although not shown, the frame 700 may support a valve structure and may include inner and / or outer skirts to form a prosthetic heart valve similar to the prosthetic heart valve 400.

[0125] The actuator assembly 600 may be a component of a delivery device (such as the delivery device 100 described above) and may be configured to removably couple and actuate a respective actuator / screw / actuation bolt / threaded rod of a prosthetic valve, such as the threaded rod 702 of the actuator mechanism 704 shown in part in FIGS. 29-35. With reference to FIG. 29, the actuator mechanism 704 may have first and second actuator posts / frame members 706, 708 separated by a gap through which the threaded rod 702 extends (similar to the first and second frame members 422 and 424 of the prosthetic valve 400). The threaded rod 702 may be used in place of or in addition to the threaded rods 234 and / or 426 of the prosthetic valves 200 and 400. The delivery device may include multiple actuator assemblies 600, one for each threaded rod 702 of the prosthetic valve. The delivery device may include any number of actuator assemblies (e.g., 1-15 actuator assemblies). The number of actuator assemblies of a delivery device may be determined, for example, by the number of threaded rods of a prosthetic valve that the delivery device is used to implant. For example, a delivery device with three actuator assemblies may be used with a prosthetic valve that includes three threaded rods. As another example, a delivery device with six actuator assemblies may be used with a prosthetic valve that includes six threaded rods. Although only one threaded rod 702 is shown in FIG. 29 for illustrative purposes, it will be appreciated that each pair of first and second actuator post / frame members may include a threaded rod 702.

[0126] The threaded rod 702 may include an elongated body 710 (partially shown in FIG. 33) and a head portion 712 configured to be removably coupled to a respective actuator assembly 600. As shown in FIG. 34, the head portion 712 may have a diameter D1 that is greater than a diameter D2 of the inner bore 714 of the second post 708 such that the head portion 712 is prevented from moving into the inner bore 714 of the frame 700 and abuts the outflow edge 716 of the frame 700, for example, as shown in FIG. 34. The head portion 712 of the threaded rod 702 may be used to apply a distally directed force to the frame 700, for example, during radial expansion of the frame 700. The frame 700 may be similar to the frame 402 of the prosthetic heart valve 400.

[0127] 32, head portion 712 may include a central recess 718 and a circumferential recess 720 extending around head portion 712. In the illustrated embodiment, central recess 718 is configured as a square recess, however, in some embodiments, central recess may have rounded corners (e.g., similar to recess 520) or may have any of a variety of other non-circular shapes, such as rectangular, oval, triangular, star-shaped, etc. In some embodiments, central recess 718 may have one or more surfaces that engage with corresponding surfaces of engaging member 624 of the driver head such that when engaging member 624 is disposed within central recess 718, rotational movement of driver 604 rotates threaded rod 702. In some embodiments, central recess 718 may be threaded and engaging member 624 may have a corresponding threaded shape such that the two components may be coupled together. In such embodiments, central recess 718 and / or engaging member 624 may have a circular shaped cross section. The circumferential recess 720 of the head portion 712 can have a substantially tube-like shape with an angled / chamfered proximal surface 724 (FIG. 33), which can, for example, facilitate mating with a delivery device described below.

[0128] Rotation of the threaded rod 702 relative to the frame 700 (e.g., using the actuator assembly 600 of the delivery device) results in relative axial movement between the inflow and outflow ends of the frame 700, which in turn results in radial expansion or compression of the frame. For example, moving the inflow and outflow ends toward one another (via rotation of the rod 702) causes the frame 700 to shorten axially and expand radially. Conversely, moving the inflow and outflow ends away from one another (via rotation of the rod 702) causes the frame 700 to elongate axially and compress radially.

[0129] 33-35 , each actuation assembly 600 can include a first actuation member configured as a support tube or outer sleeve 602 and a second actuation member configured as a driver 604. As shown, the driver 604 can extend through the outer sleeve / support tube 602. Distal end portions of the outer sleeve 602 and the driver 604 can be configured to engage or abut the head portion 712 of the threaded rod 702 and / or the outflow end portion 722 of the frame 700.

[0130] The proximal portions of the outer sleeve 602 and the driver 604 may be operably coupled to a handle of a delivery device (e.g., the handle 104 of the delivery device 100). The delivery device in this embodiment may include the same or similar features as described above for the delivery device 100. In some examples, the proximal end portion of each driver 604 may be operably connected to the knob 112 such that rotation (clockwise or counterclockwise) of the knob 112 causes a corresponding rotation of the driver 604. The proximal end portion of each outer sleeve 602 may be operably connected to the knob 114 such that rotation (clockwise or counterclockwise) of the knob 114 causes a corresponding axial movement (proximal or distal) of the sleeve 602 relative to the driver 604. In some examples, the handle may include an electric motor, button, switch, circuitry, or the like for actuating these components.

[0131] 31 , the outer sleeve 602 can include a first or distal end portion 606 and an elongated body 612. The distal end portion 606 of the outer sleeve 602 can be comprised of first and second support extensions 608 that define a gap or notch 610 ( FIG. 30 ) therebetween. The support extensions 608 and notch 610 can function in the same or similar manner as described for the support extensions 534 and notch 535 above. In some embodiments, the distal end portion 606 of the outer sleeve 602 can include a different material and / or structure than the elongated body 612.

[0132] 33, the driver 604 may include an elongated body 614 and an engagement portion 616 disposed at a distal end portion of the elongated body 614. The engagement portion 616 may include a driver head 618 and a gripper member 620. As shown in the illustrated embodiment, the driver head 618 and the gripper member 620 may be coupled to the elongated body 614. In some embodiments, the driver head 618 and / or the gripper portion 620 may be friction-fit, welded, or otherwise coupled to the elongated body 614. In some embodiments, the driver head 618 and the elongated body 614 may be integrally formed with one another. The engagement portion 616 may be coupled to the elongated body 614 using any of the structures / methods described above for the gripper member 546 and / or the driver head 544.

[0133] 33, the driver head 618 may be comprised of a body 622 including an engagement member 624 and one or more extension members / protrusions 626 (FIG. 31). The one or more protrusions 626 may extend radially outward from the body 622 and may be spaced apart from one another around the circumference of the driver head 618. As shown in FIG. 31, the protrusions 626 may include an elongated rectangular prism shape including chamfered side edges. In some embodiments, the protrusions 626 may have any of a variety of other shapes.

[0134] The engagement members 624 may extend distally from the body 622 and may be configured to engage with recesses 718 of the respective threaded rods 702. In the illustrated embodiment, the engagement members 624 have a square shape in cross-section, however, in some embodiments, the engagement members 624 may have any of a variety of non-circular shapes, e.g., rectangular, triangular, oval, star-shaped, etc. The recesses 718 of the head portion 712 of the threaded rods 702 may be correspondingly shaped to receive the engagement members 624. The shape of the engagement members 624 and corresponding recesses 718 may advantageously improve torque transmission from the driver 604 to the threaded rods 702, for example.

[0135] 31 , gripper member 620 may include an annular base member 628 and one or more extension members / wings / arms 630 configured similar to a chuck or collet. Collet-like arms 630 may be disposed about head portion 712 of threaded rod 702 to releasably engage actuator assembly 600 with actuator mechanism 704 of frame 700. Arms 630 may be movable between an expanded configuration (e.g., when outer sleeve 602 moves proximally relative to arms 630) and a compressed configuration (e.g., when outer sleeve 602 is advanced distally over arms 630).

[0136] With reference to FIG. 33 , the arms 630 may extend distally from the base member 628 and each may include a wider end 632 (also referred to as a protrusion, projection, or tooth 632) disposed at a distal end portion of the arm 630 and extending radially inward toward the longitudinal axis of the driver 604. The tooth 632 may be configured (e.g., sized and shaped) to fit within a circumferential recess 720 of the head portion 712 when the actuator assembly 600 is coupled to the frame 700, as shown in FIG. 33 . As shown, the tooth 632 may include an angled or sloped proximal surface 634 ( FIG. 34 ) that may correspond to the chamfered surface 724 of the circumferential recess 720. Such a configuration may advantageously allow the arms 630 to easily slide in and out of engagement with the circumferential recess 720. 33, the distal end portion 636 of each arm 630 may flare radially outward (e.g., away from the longitudinal axis of the driver 604) such that the distal end portion 636 extends radially outward relative to the body 638 of the arm 630 and such that the outer surface of the distal end portion 636 is spaced radially outward from the outer surface of the body 638. In other words, the distal end portion 636 of each arm 630 may be radially thicker than the body 638 of the arm 630, as seen in FIG. 33. Such a configuration may improve engagement of the teeth 632 with the circumferential recesses 720 by increasing contact between the outer sleeve 602 and the distal end portion 636.

[0137] The arms 630 may be configured to be biased radially outward (e.g., away from the longitudinal axis of the driver 604) into an expanded shape, for example, by shaping the arms 630 using any of a variety of known methods. In the illustrated embodiment, the gripper member 620 includes four arms, which advantageously spreads the engagement force more evenly around the circumference of the head portion 712. However, in some embodiments, the gripper member 620 may include any number of arms 630, e.g., 1, 2, 3, 4, 5, 6, 7, 8, etc.

[0138] As shown in FIG. 32 , the distal end portion 636 of each arm 630 may have an increased circumferential width relative to the body 638 of the arm 630. The increased width may advantageously improve engagement of the distal end portion 636 with the circumferential recess 720 of the head portion 712. The cross-sectional shape of each arm 630 may be circumferentially arcuate (i.e., each arm may be curved in a cross section taken in a plane perpendicular to the longitudinal axis of the arm), which may, for example, help the arm 630 resist bending in the circumferential direction. The narrower body 638 of the arm 630 reduces the curved width such that the arm 630, for example, may be more easily bent radially (e.g., as the arm is pulled toward or away from engagement with the head portion 712).

[0139] 31 , the protrusions 626 of the driver head 618 may extend between the arms 630 such that the arms 630 rest within recesses defined between the protrusions 626 when the actuator assembly 600 engages the frame 700. The protrusions 626 may, among other things, hold the arms in an engaged configuration and / or prevent lateral displacement of the arms 630, thereby improving stability of the arms 630 without having to weld or otherwise secure the arms around the driver head 618. This may advantageously maintain engagement stability without having to weld such small components, for example.

[0140] In some examples, the actuator assembly 600 can be coupled to the respective actuator mechanism 704 of the prosthetic valve as follows: The engagement portion 616 of the driver 604 can be advanced over the head portion 712 of the threaded rod 702. The arms 630 can be deflected radially outward as they advance over the head portion 712 until the teeth 632 are disposed within the circumferential recesses 720 and the engagement members 624 of the driver 604 are disposed within the central recesses 718. As the outer sleeve 602 advances (e.g., distally) over the driver 604, the distal end portions 636 of the arms 630 are radially compressed, thereby retaining the teeth 632 within the circumferential recesses 720 and coupling the actuator assembly 600 to the threaded rod 702 (e.g., as shown in FIG. 33). The outer sleeve 602 can continue to advance until the support extensions 608 engage the radially inner and outer surfaces of the frame 700, as shown in FIG. 30. When so coupled, the driver 604 can be rotated (e.g., with the handle of the delivery device 100) to cause a corresponding rotation of the threaded rod 702. The engagement between the actuator assembly 600 and the threaded rod 702 can advantageously improve torque transfer between the driver 604 and the threaded rod 702.

[0141] The delivery device and prosthetic valve thus coupled can be advanced over a guidewire through the patient's vasculature to a selected implantation site (e.g., the native aortic valve annulus). For example, if the prosthetic valve is to be implanted within a native aortic valve, the delivery device and prosthetic valve can be inserted into and through the femoral artery, through the aorta, and into the native aortic valve. The prosthetic valve can then be deployed at the implantation site (e.g., within the native aortic valve) and expanded and locked in an expanded configuration using actuator mechanism 704.

[0142] 30-32 (FIGS. 33-35 show cross-sectional views of the same process), once final positioning and expansion of the prosthetic valve is achieved, the actuator assembly 600 may be released from the prosthetic valve in the following exemplary manner: The outer sleeve 602 may be retracted to expose the connection between the driver 604 and the threaded rod 702, as shown in FIGS. 31 and 34. With the outer sleeve proximal to the distal end portion 636 of the arm 630, the arm 630 may be moved radially outward (e.g., due to the shape setting being in a radially expanded / disengaged state and / or by contacting the head portion 712 of the threaded rod 702). The angled surface 724 of the head portion 712 may help to facilitate radial expansion of the arm 630, for example, as the arm 630 moves proximally from the circumferential recess 720. 32 and 35, the driver 604 can then be retracted to remove the engagement member 624 from within the recess 718 of the rod 702, thereby separating the driver 604 from the rod 702. At this stage, the delivery device (including the actuator assembly 600) can be retracted relative to the prosthetic valve and removed from the patient's body.

[0143] 36-41 show another example of an actuator assembly 800 (FIG. 39) of a delivery device that may be used to radially expand and / or compress a prosthetic valve. The actuator assembly 800 may be similar to the actuator assemblies 500 and 600 described above, except that one or more arms / extension members / wings 838 of the gripper member 818 may have a uniform thickness, which advantageously facilitates manufacturing without the need for a rod rotation procedure. The gripper member 818 may also be configured to be advantageously coupled to the driver 804 without the need for welding, as described in more detail below.

[0144] 39-41 show actuator assembly 800 used on a portion of an exemplary frame 902 of prosthetic valve 900, however actuator assembly 800 may be used on any of the prosthetic valves described herein and / or any other prosthetic valves having a similar expansion mechanism. While only a portion of frame 902 is shown, it will be appreciated that frame 902 is an annular structure capable of supporting a valve structure and may include inner and / or outer skirts to form prosthetic heart valve 900 similar to prosthetic heart valve 400.

[0145] The actuator assembly 800 may be a component of a delivery device (such as the delivery device 100 described above) and may be configured to removably couple and actuate a respective actuator / screw / actuation bolt / threaded rod of the prosthetic valve 900, such as the threaded rod 904 of the actuator mechanism 906 partially shown in FIGS. 39-41. The actuator mechanism 906 may be the same as or similar to the actuator mechanisms 206, 406, and / or 704 described above. The rod 904 may be used in place of or in addition to the rods 234, 426, and / or 702 of the prosthetic valves 200, 400, and 700 described herein. The delivery device may include multiple actuator assemblies 800, one for each rod 904 of the prosthetic valve 900. The delivery device may include any number of actuator assemblies (e.g., 1-15 actuator assemblies). The number of actuation assemblies of the delivery device may be determined, for example, by the number of threaded rods of the prosthetic valve that the delivery device is used to implant.

[0146] 36, the rod 904 may include an elongated body 908 (partially shown) and a head portion 910 configured to be removably coupled to a respective actuator assembly 800. The elongated body 908 may include a threaded portion (not shown). The head portion 910 may have an overall Ω shape with a protrusion 912 including a protrusion head 914 and a protrusion neck 916, and a flared base 918. The protrusion head 914 may have a width W1 that is greater than a width W2 of the protrusion neck 916. The protrusion 912 and the flared base 918 together may define first and second curved recesses 920 on opposite sides of the head portion 910. 41, the flared base 918 can have a diameter D1 that is greater than a diameter D2 of the opening 922 in the frame 902 such that the head portion 910 is prevented from moving into the frame 902 and the head portion 910 abuts the outflow edge of the frame, for example, as shown in FIG 41. The head portion 910 of the rod 904 can be used to apply a force distally to the frame 902, for example, during radial expansion of the frame 902.

[0147] Rotation of the threaded rod 904 relative to the frame 902 (e.g., using the delivery device's actuator assembly 800) results in relative axial movement between the inflow and outflow ends of the frame 902, which in turn results in radial expansion or compression of the frame. For example, moving the inflow and outflow ends toward one another (via rotation of the rod 904 in a first direction) causes the frame 902 to shorten axially and expand radially. Conversely, moving the inflow and outflow ends away from one another (via rotation of the rod 904 in a second direction) causes the frame 902 to elongate axially and compress radially.

[0148] 39-41 , each actuation assembly 800 may include a first actuation member configured as a support tube or outer sleeve 802 (shown in dashed lines in FIGS. 39-40 ) and a second actuation member configured as a driver 804. The driver 804 may extend through the outer sleeve 802 as shown. Distal end portions of the outer sleeve 802 and the driver 804 may be configured to engage or abut a head portion 910 of the rod 904 and / or a portion of the frame 902.

[0149] The proximal portions of the outer sleeve 802 and the driver 804 may be operably coupled to a handle of a delivery device (e.g., the handle 104 of the delivery device 100). The delivery device of this example may include the same or similar features as described above for the delivery device 100. In some examples, the proximal end portion of each driver 804 may be operably connected to the knob 112 such that rotation (clockwise or counterclockwise) of the knob 112 causes a corresponding rotation of the driver 804. The proximal end portion of each outer sleeve 802 may be operably connected to the knob 114 such that rotation (clockwise or counterclockwise) of the knob 114 causes a corresponding axial movement (proximal or distal) of the sleeve 802 relative to the driver 804. In some examples, the handle may include an electric motor, button, switch, circuitry, or the like for actuating these components.

[0150] 39, the distal end portion 806 of the outer sleeve 802 may be comprised of first and second support extensions 808 that define a gap or notch 810 therebetween. The support extensions 808 and notch 810 may function in the same or similar manner as described for the support extensions 534 / 608 and notches 535 / 610 previously described.

[0151] The driver 804 may include an elongate body 812 (FIG. 41) and an engagement portion 814 disposed at a distal end portion thereof. The engagement portion 814 may include a driver head 816 and a gripper member 818.

[0152] 37, driver head 816 can include a body 820 including a first end 822 having a first end face 824, a second end 826 having a second end face 828, and first and second shoulders 830 extending radially outward from second end 826. In some examples, as shown, body 820 can have a substantially cylindrical shape.

[0153] As shown in FIG. 41, the second end surface 828 can include an engagement recess 832 extending into the body 820 and configured (e.g., sized and shaped) to engage with the protrusion head 914 of the rod 904. The engagement recess 832 can have a substantially semicircular shape in cross section. With reference to FIGS. 37 and 39-40, the shoulder 830 can include a notch 834, such as a semicircular shaped notch, configured (e.g., sized and shaped) to engage with the protrusion head 914. In some embodiments, the engagement recess 832 and the notch 834 can have any of a variety of shapes in cross section to be configured to receive the protrusion 912 of the rod 904. The shapes of the engagement recess 832, the notch 834, and the corresponding protrusion 912 can advantageously improve torque transmission from the driver 804 to the rod 904, for example.

[0154] 38, the gripper member 818 may include an annular base member 836 and one or more extension members / wings / arms 838. In the illustrated example, the gripper member 818 has first and second diametrically opposed arms 838 defining first and second diametrically opposed recesses 840 therebetween. The recesses 840 may have an Ω shape that substantially corresponds to the Ω shape of the head portion 910 of the rod 904. In some embodiments, the gripper member 818 may have any number of arms and any number of recesses. In some embodiments, the arms 838 may be movable between an expanded configuration (e.g., when the outer sleeve 802 is moved to a proximal position relative to the arms 838) and a compressed configuration (e.g., when the outer sleeve 802 is advanced distally and positioned over the arms 838).

[0155] As shown, the arms 838 may extend distally from the base member 836 and may include a proximal neck portion 842 having a first circumferential width and a distal end portion 844 having a second, wider circumferential width. The distal end portion 844 may include a circumferentially extending curved protrusion 846 configured to be disposed within a curved recess 920 of the rod head 910 such that the gripper members 818 engage the rod 904, as shown in FIG. 40. The increased width of the distal end portion 844, including the curved protrusion 846, may advantageously improve engagement of the distal end portion 844 with the curved recess 920 of the rod head 910. The cross-sectional shape of each arm 838 may be circumferentially arcuate (i.e., each arm may be curved in a cross section taken in a plane perpendicular to the longitudinal axis of the arm), which may help, for example, the arms 838 resist bending in the circumferential direction. The narrower neck portion 842 of the arm 838 reduces the curved width so that the arm 838 can, for example, bend radially more easily (e.g., when the arm is pulled toward or away from engagement with the head portion 910).

[0156] For example, as can be seen in FIG. 41 , unlike the arms 630 of the gripper member 620, the arms 838 have a uniform thickness from the base member 836 to the distal end portion 844. Such a configuration advantageously allows for easier manufacturing of the gripper members 818, for example, using laser cutting and shape setting (e.g., heat setting) of the arms without the need for a rod turning procedure. In some embodiments, the gripper members 818 can include Nitinol. The arms 838 can be configured to be biased radially outward (e.g., away from the longitudinal axis of the driver 804) into an expanded shape, for example, by shape setting (e.g., heat setting) the arms 838 using any of a variety of known methods. In the illustrated embodiment, the gripper members 818 include two arms 838, although in some embodiments, the gripper members can include any number of arms.

[0157] The driver head 816 and the gripper member 818 may each be coupled to the elongated body 812 of the driver 804. For example, as shown in FIGS. 39-41 , the driver 804 may include a coupling member 848, such as a cylindrical tube, that is coupled (e.g., welded) at a first end 850 to the elongated body 812 and at a second end 852 to the driver head 816. For example, as can be seen in FIG. 41 , the gripper member 818 may be disposed on the driver head 816 at a location distal to the coupling member 848 such that a proximal edge 854 of the annular base member 836 abuts a distal edge 856 of the coupling member 848. As shown in FIG. 40 , this positions the shoulders 830 of the driver head 816 within respective proximal portions 858 of respective recesses 840. Gripper member 818 is thereby constrained from axial and rotational movement relative to driver head 816 and elongate body 812 by engagement of shoulder 830 and distal edge portion 856 of coupling member 848. Gripper member 818 is therefore advantageously coupled to elongate body 812 without the need for welding, which simplifies the manufacturing process.

[0158] In some embodiments, the driver head 816 and / or the gripper member 818 may be friction-fit, welded, or otherwise coupled to the elongate body 812. In some embodiments, the driver head 816 and the elongate body 812 may be integrally formed with one another. In some embodiments, the engagement portion 814 may be coupled to the elongate body 812 using any of the structures / methods described above for the gripper members 546 / 620 and / or the driver heads 544 / 618.

[0159] In some examples, the actuator assembly 800 can be coupled to the respective actuator mechanism 906 of the prosthetic valve as follows: With reference to FIG. 39, the engagement portion 814 of the driver 804 can be advanced over the head portion 910 of the rod 904 in the direction indicated by arrow 859. The arms 838 can flex radially outward as they advance over the head portion 910 until the curved projections 846 are disposed within the curved recesses 920 of the rod head 910 and the engagement recesses 832 of the driver head 816 engage the projection head 914 of the rod. As the outer sleeve 802 advances (e.g., distally) over the engagement portion 814, the distal end portions 844 of the arms 838 are radially compressed, thereby retaining the curved projections 846 within the curved recesses 920 and coupling the actuator assembly 800 to the rod 904 (e.g., as shown in FIGS. 40-41). The outer sleeve 802 can continue to advance until the support extensions 808 engage radially inner and outer surfaces of the frame 902, as shown, for example, in FIG. 40. The driver 804 thus coupled can be rotated (e.g., using the handle of the delivery device 100) to cause corresponding rotation of the rod 904. The engagement between the actuator assembly 800 and the rod 904 can advantageously improve torque transfer between the driver 804 and the threaded rod 904.

[0160] The delivery device and prosthetic valve thus coupled can be advanced over a guidewire through the patient's vasculature to a selected implantation site (e.g., the native aortic valve annulus). For example, if the prosthetic valve is to be implanted within a native aortic valve, the delivery device and prosthetic valve can be inserted into and through the femoral artery, through the aorta, and into the native aortic valve. The prosthetic valve can then be deployed at the implantation site (e.g., within the native aortic valve) and expanded and locked in an expanded configuration using actuator mechanism 704.

[0161] Once final positioning and expansion of the prosthetic valve has been achieved, the actuator assembly 800 may be released from the prosthetic valve in the following exemplary manner: The outer sleeve 802 may be retracted to expose the connection between the driver 804 and the rod 904. Proximalization of the outer sleeve relative to the distal end portion 844 of the arm 838 allows the arm 838 to move radially outward (e.g., to be shaped to a radially expanded / disengaged state). The driver 804 may then be retracted, disengaging the engagement recess 832 of the driver head 816 from the projection head 914, thereby separating the driver 804 from the rod 904. At this stage, the delivery device (including the actuator assembly 800) may be retracted relative to the prosthetic valve and removed from the patient's body.

[0162] In some cases, the outer sleeve (such as the outer sleeves 302, 524, 602, or 802 described above) may inadvertently slip or bend during delivery or use, resulting in premature release of the arms and inadvertent disengagement of the actuation assembly from the frame. With reference to FIGS. 42-46, in some embodiments, instead of or in addition to the outer sleeves 302, 524, 602, and 802 described above, any of the actuation assemblies described herein may comprise an outer sleeve 1000, at least a portion of which is configured as a hypotube 1002. FIG. 44 shows the outer sleeve 1000 in a transparent manner for illustrative purposes. The hypotube 1002 may be expandable and compressible between a first length and a second length. During use, the outer sleeve 1000 may be initially disposed around a driver (e.g., any of the drivers described herein) in a compressed configuration such that even if the outer sleeve 1000 and driver bend during delivery or use, the outer sleeve 1000 may be advantageously biased into an extended configuration in which the arms of the driver remain covered and therefore restrained.

[0163] As shown in FIG. 42, the hypotube 1002 may include a plurality of compressible and expandable diamond-shaped openings or slots 1004 extending at least partially around the circumference of the outer sleeve 1000. The slots 1004 may be axially separated from one another by circumferentially extending members or ribs 1006. As described above, the hypotube 1002 may be movable between an expanded configuration having a first overall length in which the ribs are separated from one another by a first distance D1 (FIG. 45) and a compressed configuration in which the ribs are separated from one another by a second distance D2 (FIG. 46) that is less than the first distance. Although the difference between D1 and D2 may be very small (e.g., on the order of microns), the combined expansion of one or more slots 1004 may result in an overall elongation of the hypotube portion 1002 (e.g., on the order of several centimeters). The hypotube 1002 may be configured to be biased into the expanded configuration. In some examples, the hypotube 1002 may be a laser cut tube.

[0164] The diamond shaped slot 1004 can be configured (e.g., sized and shaped) to provide the desired extension and resulting force. For example, the slot 1004 can be configured to provide a low force, but a greater extension. Axial preloading of the hypotube portion prevents or mitigates undesired movement of the outer sleeve (e.g., caused by bending during navigation through the patient's anatomy) by allowing the hypotube to expand (e.g., in a compression spring-like manner) when there is available space. In some cases, undesired movement can undesirably decouple the actuator assembly from the prosthetic valve, and therefore, it is important to mitigate such movement.

[0165] In some embodiments, the outer sleeve 1000 may further function to visually indicate to the physician that the actuator assembly has been successfully released from the prosthetic valve. For example, this may be done by releasing a mechanical latch at the proximal end of the loaded outer sleeve. When the latch is released, a proximal end portion of the outer sleeve may expand in a proximal direction (e.g., toward the physician), not only releasing the outer sleeve from the prosthetic valve, but also moving the entire outer sleeve in a proximal direction, thereby providing a visual gap between the distal end of the actuator assembly and the prosthetic heart valve visible on an x-ray screen.

[0166] For example, as shown in FIG. 43, the outer sleeve 1000 may include a first elongated portion 1008 including the hypotube 1002 and a non-hypotube second portion 1010 at its distal end. The second portion 1010 may be comprised of first and second support extensions 1012 defining a gap or notch 1014 therebetween. The support extensions 1012 and notch 1014 may function in the same or similar manner as described for the support extensions 608 / 534 / 808 and notches 610 / 535 / 810 previously described. For example, as shown in FIG. 43, the first support extension 1012 may extend partially over a radially inner surface 1016 of a frame 1018 of a prosthetic valve 1020 and the second support extension 1012 may extend partially over a radially outer surface 1022 of the frame 1018 to inhibit rotation of the frame 1018 relative to the actuator assembly. In some embodiments, the distal end portion 1010 of the outer sleeve 1000 may comprise a different material and / or structure than the first portion.

[0167] During delivery and / or use, the outer sleeve 1000 with the hypotube 1002 may be axially preloaded to be placed over a driver (such as drivers 304, 526, 604, or 804 described herein) in a compressed configuration. If the outer sleeve is flexed during delivery or use, the hypotube portion 1002 advantageously expands, allowing the distal end portion 1010 to remain in place on the arm, thereby preventing inadvertent expansion of the arm.

[0168] 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.

[0169] Treatment techniques, methods, steps, etc., as described or suggested herein, or as described or suggested in the references incorporated herein, may be performed on live animals or may be performed on non-biological simulations, such as cadavers, cadaver hearts, anthropomorphic ghosts, simulators (e.g., in which body parts, tissues, etc. are simulated), etc. Further Examples of the Disclosed Technology

[0170] 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 any 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.

[0171] Example 1. An assembly comprising: 1. A prosthetic heart valve comprising: a radially expandable and compressible frame having an inlet end portion, an outlet end portion, and a plurality of actuator mechanisms, each actuator mechanism comprising: a first frame member having a first internal bore and a second frame member having a second internal bore, the first and second frame members being axially spaced from one another; a prosthetic heart valve having an actuator having an external threaded surface and extending through said first and second internal holes; 1. A delivery device comprising: A handle and and one or more actuator assemblies extending from the handle, each actuator assembly comprising: a first actuating member having a distal end portion removably coupled to the outflow end portion of the frame, the distal end portion including first and second support extensions; a second actuation member extending through the first actuation member and including a distal end portion having an engagement portion removably coupled to the rod; rotation of the second actuation member in a first direction causes a corresponding rotation of the rod such that the first and second members move axially toward one another to expand the prosthetic valve; a delivery device, wherein the first and second support extensions inhibit rotation of the frame relative to the one or more actuator assemblies during expansion of the prosthetic valve.

[0172] Example 2. The assembly described in any of the examples herein, particularly Example 1, wherein the first support extension extends partially onto the radially inner surface of the frame and the second support extension extends partially onto the radially outer surface of the frame.

[0173] Example 3. The assembly described in any of the examples herein, particularly any one of Examples 1-2, wherein the proximal end portion of the actuator includes first and second protrusions defining a slot therebetween.

[0174] Example 4. The assembly of any example herein, especially example 3, wherein the engagement portion includes a central protrusion that extends into the slot.

[0175] Example 5. The assembly of any example herein, especially example 4, wherein the central protrusion is sized so as not to contact the inner surface of the first actuation member.

[0176] Example 6. The assembly described in any of the examples herein, particularly any one of Examples 1-5, wherein the proximal end portion of the actuator includes one or more shoulders extending radially from a surface of the actuator.

[0177] Example 7. The assembly described in any of the examples herein, especially example 6, wherein the engagement portion comprises one or more flexible elongate elements removably coupled to the shoulder.

[0178] Example 8. The assembly of any example herein, particularly example 7, wherein each elongate element comprises a protrusion extending radially inwardly toward the longitudinal axis of the second actuation member.

[0179] Example 9. The assembly of any embodiment herein, particularly example 7, wherein the one or more elongate elements bias radially outward from the longitudinal axis of the second actuation member.

[0180] Example 10. An assembly as described in any of the embodiments herein, particularly any one of embodiments 1-9, wherein rotation of the second actuating member in a second direction causes corresponding rotation of the actuator such that the first and second frame members move axially away from one another to radially compress the prosthetic valve.

[0181] Example 11. An assembly as described in any of the embodiments herein, particularly any one of Examples 1-10, wherein each actuator includes a stopper axially disposed between the first and second frame members, the stopper configured to selectively abut an inflow end portion of the second frame member to prevent over-crimping of the frames.

[0182] Example 12. An assembly as described in any of the embodiments herein, particularly any one of embodiments 1-11, wherein each first frame member has a nut disposed on an outflow end portion of the first frame member, the nut having an internally threaded bore configured to engage an externally threaded surface of the actuator.

[0183] Example 13. The assembly of any embodiment herein, especially example 12, wherein the nut is visible through a window extending through the wall of the first member.

[0184] Example 14. The assembly of any example herein, particularly any one of Examples 1-13, wherein the frame comprises a plurality of circumferentially arranged hexagonal cells.

[0185] Example 15. The assembly of any of the examples herein, especially example 14, wherein each hexagonal cell includes diamond cells disposed within the perimeter of the hexagonal cell.

[0186] Example 16. The assembly of any of the embodiments herein, particularly Example 15, wherein each hexagonal cell and diamond cell includes an inlet apex and an outlet apex, and each actuator extends through the inlet and outlet apex.

[0187] Example 17. The assembly of any embodiment herein, particularly any one of Examples 1-16, wherein the frame further comprises one or more axially extending support posts.

[0188] Example 18. The assembly of any of the embodiments herein, particularly any one of Examples 1-17, wherein each of the plurality of actuator mechanisms is coupled to one or more support posts by a plurality of struts.

[0189] Example 19. The assembly of any embodiment herein, especially Example 18, wherein the struts are curved.

[0190] Example 20. The assembly of any of the embodiments herein, particularly any one of Examples 18-19, wherein each strut has a recurved shape including a first portion and a second portion separated by an inflection point.

[0191] Example 21. The assembly of any of the embodiments herein, especially example 20, wherein the first portion is an upwardly curved portion and the second portion is a downwardly curved portion.

[0192] Example 22. An assembly as described in any of the embodiments herein, particularly any one of embodiments 18-21, wherein each strut includes a first end portion and a second end portion, the first and second end portions terminating asymptotically to at least one of the respective support posts and actuator mechanisms.

[0193] Example 23. The assembly of any embodiment herein, particularly any one of embodiments 1-22, wherein each actuator is configured as at least one of a right hand rod and a left hand rod.

[0194] Example 24. The assembly described in any of the embodiments herein, particularly Example 23, wherein the prosthetic heart valve comprises six actuator mechanisms, the actuators of the actuator mechanisms alternating between right and left hand rods around the circumference of the frame.

[0195] Example 25. An assembly comprising: 1. A prosthetic heart valve comprising: a radially expandable and compressible frame having an inlet end portion and an outlet end portion, the frame including a plurality of actuation mechanisms, each actuation mechanism comprising: a first frame member having a first inner bore and a second frame member having a second inner bore, the first and second frame members being axially spaced from one another; a rod having an externally threaded surface and extending through the first and second internal holes, a proximal end portion of the rod including first and second projections and first and second shoulders defining a slot therebetween; and 1. A delivery device comprising: A handle and and one or more actuator assemblies extending from the handle, each actuator assembly comprising: a first actuating member having a distal end portion abutting the outflow end portion of the frame; a second actuating member extending through the first actuating member, the second actuating member including a distal end portion having a central projection extending into the slot and first and second flexible elongate elements removably coupled to the shoulder; a delivery device, wherein rotation of the second actuation member in a first direction causes corresponding rotation of the rod such that the first and second frame members move axially toward one another to expand the prosthetic valve.

[0196] Example 26. The assembly described in any of the examples herein, particularly example 25, wherein the first actuating member further comprises first and second support extensions configured to inhibit rotation of the frame relative to the first actuating member during expansion of the frame.

[0197] Example 27. The assembly described in any of the embodiments herein, particularly Example 26, wherein the first support extension extends partially onto the radially inner surface of the frame and the second support extension extends partially onto the radially outer surface of the frame.

[0198] Example 28. The assembly of any embodiment herein, particularly any one of Examples 25-27, wherein the central projection is sized so as not to contact the inner surface of the first actuation member.

[0199] Example 29. The assembly of any embodiment herein, particularly any one of embodiments 25-28, wherein each elongate element includes a radially inwardly extending protrusion.

[0200] Example 30. The assembly of any embodiment herein, particularly example 29, wherein the one or more elongate elements bias radially outward from the longitudinal axis of the second actuation member.

[0201] Example 31. An assembly described in any of the embodiments herein, particularly any one of embodiments 25-30, wherein rotation of the second actuating member in a second direction causes corresponding rotation of the rod such that the first and second frame members move axially away from one another to radially compress the prosthetic valve.

[0202] Example 32. An assembly described in any of the embodiments herein, particularly any one of Examples 25-31, wherein each rod includes a stopper disposed between the first frame member and the second frame member, the stopper configured to selectively abut an inflow end portion of the second frame member to prevent over-crimping of the frame.

[0203] Example 33. An assembly as described in any of the embodiments herein, particularly any one of embodiments 25-32, wherein each first frame member has a nut disposed at an outflow end portion of the first member, the nut having an internal threaded bore configured to engage with a threaded rod.

[0204] Example 34. The assembly of any example herein, especially example 33, wherein the nut is visible through a window extending through the wall of the first frame member.

[0205] Example 35. A method for manufacturing a gyro sensor, comprising: one or more of the posts are configured as the actuation mechanism; The assembly of any embodiment herein, particularly any one of embodiments 25-34, wherein the plurality of posts are connected to one another by a plurality of struts.

[0206] Example 36 The assembly of any embodiment herein, especially example 35, wherein the struts are curved.

[0207] Example 37. The assembly described in any of the examples herein, particularly any one of Examples 25-26, wherein each strut has a recurved shape including a first portion and a second portion separated by an inflection point.

[0208] Example 38. The assembly of any embodiment herein, especially example 37, wherein the first portion is an upwardly curved portion and the second portion is a downwardly curved portion.

[0209] Example 39. An assembly as described in any of the embodiments herein, particularly any one of Examples 25-38, wherein each strut includes a first end portion and a second end portion, the first and second end portions terminating asymptotically relative to the respective post.

[0210] Example 40. A delivery device comprising: A handle and One or more actuator assemblies extending from the handle, each actuator assembly comprising: a first actuation member having a distal end portion configured to abut an outflow end portion of the prosthetic heart valve, the distal end portion including first and second support extensions; a second actuating member extending through the first actuating member and having a distal end portion configured to releasably couple to an actuator of a prosthetic heart valve; Rotation of the second actuation member in a first direction radially expands the prosthetic valve and rotation of the second actuation member in a second direction radially compresses the prosthetic valve; A delivery device, wherein a first support extension is configured to extend partially onto a radially inner surface of the prosthetic valve and a second support extension is configured to extend partially onto a radially outer surface of the prosthetic valve to inhibit rotation of a frame of the prosthetic valve relative to the actuator assembly.

[0211] Example 41 The delivery device of any embodiment herein, especially example 40, wherein the second actuation member comprises a central protrusion.

[0212] Example 42 A delivery device as described in any embodiment herein, especially example 41, wherein the central protrusion is sized so as not to contact the inner surface of the first actuation member.

[0213] Example 43. A delivery device as described in any of the embodiments herein, particularly any one of embodiments 40-42, wherein the distal end portion of the second actuation member comprises one or more flexible elongate elements.

[0214] Example 44. A delivery device as described in any of the examples herein, particularly example 43, wherein each elongate element comprises a protrusion extending radially inward toward the longitudinal axis of the second actuation member.

[0215] Example 45. The delivery device of any of the embodiments herein, particularly example 44, wherein the one or more elongate elements bias radially outward from the longitudinal axis of the second actuation member.

[0216] Example 46. An implantable prosthetic device comprising: a radially expandable and compressible frame having an inlet end portion and an outlet end portion, the frame comprising: A plurality of posts, one or more of which: a first frame member having a first internal aperture; a second frame member having a second internal bore, the first and second frame members being axially spaced from one another; and a plurality of posts configured as an actuation mechanism comprising: an actuator having an externally threaded surface and extending through the first and second internal bores, a proximal end portion of the actuator comprising first and second projections defining a slot therebetween and first and second shoulders extending radially from an outer surface of the actuator; a plurality of struts connecting adjacent posts to each other; A prosthetic device, wherein rotation of an actuator in a first direction causes axial movement of the first and second frame members toward one another to radially expand the prosthetic device.

[0217] Example 47. The prosthetic device of any of the examples herein, particularly example 46, further comprising a valve structure including a plurality of leaflets disposed within the frame.

[0218] Example 48. The prosthetic device described in any of the embodiments herein, particularly any one of embodiments 46-47, wherein rotation of the actuator in a second direction causes axial movement of the first and second members away from each other, radially compressing the prosthetic device.

[0219] Example 49. An artificial device described in any of the embodiments herein, particularly any one of Examples 46-48, wherein each actuator comprises a stopper axially disposed between the first frame member and the second frame member, the stopper being configured to selectively abut against the inflow end portion of the second frame member to prevent excessive crimping of the frame.

[0220] Example 50. A prosthetic device as described in any of the embodiments herein, particularly any one of embodiments 46-49, wherein each first frame member has a nut disposed at an outflow end portion of the first frame member, the nut having an internally threaded hole configured to engage with an externally threaded surface of the rod.

[0221] Example 51. Any embodiment herein, but especially example 50, wherein the nut is visible through a window extending through the wall of the first frame member.

[0222] Example 52. The prosthetic device of any of the embodiments herein, particularly any one of embodiments 46-51, wherein the struts and posts define a plurality of circumferentially arranged hexagonal cells.

[0223] Example 53 The prosthetic device of any of the examples herein, particularly example 52, wherein each hexagonal cell comprises diamond cells disposed within the perimeter of the hexagonal cell.

[0224] Example 54. The prosthetic device of claim 53, wherein each hexagonal cell and diamond cell includes an inflow apex and an outflow apex, and each actuation mechanism extends through the inflow and outflow apex.

[0225] Example 55 The prosthetic device of any of the embodiments herein, particularly any one of embodiments 46 and 54, wherein the struts are curved.

[0226] Example 56. The prosthetic device of any of the examples herein, particularly any one of Examples 46-55, wherein each strut has a recurved shape including a first portion and a second portion separated by an inflection point.

[0227] Example 57 The prosthetic device of any of the embodiments herein, particularly example 56, wherein the first portion is an upwardly curved portion and the second portion is a downwardly curved portion.

[0228] Example 58. A prosthetic device as described in any of the embodiments herein, particularly any one of embodiments 46-57, wherein each strut has a first end portion and a second end portion, the first and second end portions terminating asymptotically to their respective posts.

[0229] Example 59. A method comprising: inserting a distal end of a delivery device into the vasculature of a patient, the delivery device being removably coupled to a prosthetic valve via a plurality of actuator assemblies, the prosthetic heart valve including a frame including a plurality of actuation mechanisms each including a first frame member, a second frame member axially spaced from the first frame member, and an actuator extending through the first and second frame members, each actuator assembly comprising a first actuation member engaging an outflow end of the prosthetic valve and a second actuation member extending through the first actuation member and engaging an outflow end of the actuator, the first actuation member comprising a first support extension extending partially onto a radially inner surface of the frame and a second support extension extending partially onto a radially outer surface of the frame; advancing the prosthetic valve to the selected implantation site; and rotating the second actuation member to cause corresponding rotation of the actuator such that the first and second frame members move axially toward one another to radially expand the prosthetic valve, wherein the first and second support extensions inhibit rotation of the frame relative to the first actuation member during expansion.

[0230] Example 60. The method of any of the embodiments herein, particularly example 59, further comprising: rotating the second actuating member in a second direction to cause corresponding rotation of the actuator, resulting in axial movement of the first and second frame members away from each other to radially compress the prosthetic valve, wherein the first and second support extensions inhibit rotation of the frame relative to the first actuating member during compression of the frame.

[0231] Example 61. The method of any of the embodiments herein, particularly any one of embodiments 59-60, wherein the actuator includes a stopper disposed between the first and second frame members, the stopper selectively abutting the inflow end of the second frame member during radial compression of the frame.

[0232] Example 62. An assembly comprising: 1. A prosthetic heart valve comprising: a radially expandable and compressible frame including an inlet end portion and an outlet end portion; one or more actuators having an external threaded surface and configured to radially expand the frame upon rotation of the one or more actuators; 1. A delivery device comprising: A handle and and one or more actuator assemblies extending from the handle, each actuator assembly comprising: a first actuating member having a distal end portion removably coupled to the outflow end portion of the frame, the distal end portion including first and second support extensions; a second actuation member extending through the first actuation member and having a distal end portion having an engagement portion, the engagement portion comprising: a driver head having an engagement member extending into a corresponding recess in a corresponding actuator; a gripper member having one or more arms removably coupled to one or more projections extending from the actuator; rotation of the second actuation member in a first direction causes the prosthetic valve to expand with a corresponding rotation of the actuator; an assembly, wherein the first and second support extensions inhibit rotation of the frame relative to the one or more actuator assemblies during expansion of the prosthetic valve.

[0233] Example 63. The assembly described in any of the embodiments herein, particularly example 62, wherein the first support extension extends partially onto the radially inner surface of the frame and the second support extension extends partially onto the radially outer surface of the frame.

[0234] Example 64. The assembly of any of the embodiments herein, particularly any one of Examples 62-63, wherein the engaging portion comprises a square shape in cross section having chamfered corners.

[0235] Example 65. The assembly of any example herein, particularly example 64, wherein the engagement member extends distally from the driver head.

[0236] Example 66 The assembly of any of the embodiments herein, particularly any one of Examples 62-65, wherein the engagement portion is sized so as not to contact the inner surface of the first actuation member.

[0237] Example 67. The assembly of any embodiment herein, particularly any one of embodiments 62-66, wherein the arms are movable between an extended position and a compressed position.

[0238] Example 68. The assembly of any embodiment herein, especially example 67, wherein the arm biases radially outward from the longitudinal axis of the second actuation member.

[0239] Example 69. The assembly of any of the embodiments herein, particularly any one of embodiments 62-68, wherein each arm has an aperture and each protrusion of the actuator is selectively disposed within the aperture.

[0240] Example 70. An assembly described in any of the embodiments herein, particularly any one of embodiments 62-69, wherein rotation of the second actuation member in a second direction causes the prosthetic valve to radially compress upon corresponding rotation of the actuator.

[0241] Example 71. An assembly described in any of the embodiments herein, particularly any one of embodiments 62-70, wherein the frame includes one or more pairs of axially spaced first and second frame members, and each actuator extends through a corresponding pair of first and second frame members.

[0242] Example 72. An assembly as described in any of the embodiments herein, particularly example 71, wherein each actuator comprises a stopper axially disposed between a corresponding pair of first and second frame members, the stopper configured to selectively abut an inflow end portion of the second frame member.

[0243] Example 73. An assembly described in any of the embodiments herein, particularly any one of embodiments 71-72, wherein each first frame member has a nut disposed at an outflow end portion of the first frame member, the nut having an internally threaded hole configured to engage with a corresponding actuator.

[0244] Example 74. A delivery device comprising: A handle and and one or more actuator assemblies extending from the handle, each actuator assembly comprising: a first actuation member having a distal end portion configured to abut an end of the prosthetic heart valve, the distal end portion including first and second support extensions; a second actuation member comprising a driver head extending through the first actuation member and having an engagement member configured to engage a corresponding engagement portion of an actuator of the prosthetic heart valve, and a gripper member having one or more arms configured to releasably couple the actuator; wherein rotation of the second actuating member in a first direction is configured to radially expand the prosthetic valve and rotation of the second actuating member in a second direction is configured to radially compress the prosthetic valve.

[0245] Example 75. A delivery device as described in any of the embodiments herein, particularly example 74, wherein the first support extension is configured to extend partially onto the radially inner surface of the prosthetic valve and the second support extension is configured to extend partially onto the radially outer surface of the prosthetic valve to inhibit rotation of the frame of the prosthetic valve relative to the actuator assembly.

[0246] Example 76. A delivery device described in any of the embodiments herein, particularly any one of embodiments 74-75, wherein the engagement portion has a square cross-section with chamfered corners.

[0247] Example 77 The delivery device of any embodiment herein, particularly example 76, wherein the engagement member extends distally from the driver head.

[0248] Example 78. A delivery device as described in any of the embodiments herein, particularly any one of embodiments 74-77, wherein the second actuation member is sized so as not to contact an inner surface of the first actuation member.

[0249] Example 79. A delivery device described in any embodiment herein, particularly any one of embodiments 74-78, wherein one or more arms comprise a plurality of arms.

[0250] Example 80 A delivery device as described in any embodiment herein, particularly embodiment 79, wherein the arms are movable between an extended position and a compressed position.

[0251] Example 81 The delivery device of any embodiment herein, particularly example 80, wherein the arm biases radially outward from the longitudinal axis of the second actuation member.

[0252] Example 82. A delivery device described in any of the embodiments herein, particularly any one of embodiments 74-81, wherein each arm has an opening configured to selectively couple to a respective protrusion of the actuator.

[0253] Example 83. A delivery device described in any of the embodiments herein, particularly any one of embodiments 74-82, configured such that rotation of the second actuating member in a second direction radially compresses the prosthetic valve upon corresponding rotation of the corresponding actuator.

[0254] Example 84. An artificial heart valve, comprising: a radially expandable and compressible frame, the frame comprising: a plurality of circumferentially spaced, axially extending posts; a plurality of circumferentially spaced pairs of axially extending frame members, each pair of frame members including an axially extending proximal frame member and an axially extending distal frame member axially spaced from the proximal frame member defining a gap therebetween, each pair of frame members being circumferentially positioned between two posts; a plurality of connecting struts coupling the posts to the proximal and distal frame members, each post (i) connected to an adjacent distal frame member of a first pair of adjacent frame members by two connecting struts, (ii) connected to an adjacent proximal frame member of the first adjacent pair by two connecting struts, (iii) connected to an adjacent distal frame member of a second pair of adjacent frame members by two connecting struts, and (iv) connected to an adjacent proximal frame member of a second adjacent pair by two connecting struts, each connecting strut having a concavely curved portion and a convexly curved portion separated by an inflection point; a plurality of actuators extending through each pair of first and second frame members, the actuators configured to radially expand the frame from a radially compressed state to a radially expanded state; a valve structure disposed within the frame and configured to regulate unidirectional blood flow through the frame.

[0255] Example 85. A prosthetic heart valve as described in any of the embodiments herein, particularly example 84, wherein the struts, posts, and proximal and distal frame members are arranged to form a plurality of hexagonal cells and a plurality of diamond-shaped cells, each diamond-shaped cell being disposed within one of the hexagonal cells.

[0256] Example 86 The prosthetic heart valve of any of the embodiments herein, particularly example 85, wherein each diamond-shaped cell is centrally disposed within a respective hexagonal cell.

[0257] Example 87. A prosthetic heart valve as described in any of the embodiments herein, particularly any one of embodiments 85-86, wherein each hexagonal cell defines an inflow apex and an outflow apex of the frame.

[0258] Example 88. The prosthetic heart valve of any embodiment herein, particularly any one of Examples 85-87, wherein exactly six hexagonal cells and exactly six diamond shaped cells are present.

[0259] Example 89. The prosthetic heart valve of any embodiment herein, particularly any one of embodiments 85-88, wherein the hexagonal cells extend the entire length of the frame.

[0260] Example 90. A prosthetic heart valve as described in any of the embodiments herein, particularly any one of embodiments 84-89, wherein the valve structure comprises a plurality of leaflets, each leaflet having two commissure tabs on either side of the leaflet, each commissure tab pairing with an adjacent commissure tab of an adjacent leaflet to form a commissure, and each commissure being secured to an adjacent post.

[0261] Example 91. The prosthetic heart valve of any of the embodiments herein, particularly example 90, wherein each post adjacent a commissure has a slot, and a pair of commissure tabs of the adjacent commissures extend through the slots.

[0262] Example 92. A prosthetic heart valve as described in any of the embodiments herein, particularly any one of embodiments 84-91, wherein the plurality of actuators comprises a threaded rod having an external thread.

[0263] Example 93. A prosthetic heart valve as described in any embodiment herein, particularly example 92, wherein for each pair of proximal and distal frame members having an actuator extending therethrough, the proximal frame member has a non-threaded hole and the distal frame member has a hole with an internal thread, the actuator extends through the non-threaded hole of the proximal frame member and the hole of the distal frame member, and the external threads of the actuator engage with the internal threads of the distal frame member.

[0264] Example 94. A prosthetic heart valve as described in any embodiment herein, particularly example 93, wherein for each pair of proximal and distal frame members having an actuator extending therethrough, the distal frame member includes a cutout region and a nut disposed within the cutout region, the nut defining an internal thread for the hole in the distal member.

[0265] Example 95. A prosthetic heart valve as described in any of the embodiments herein, particularly any one of embodiments 84-94, wherein each post includes a cantilevered extension portion extending toward the inflow end of the frame.

[0266] Example 96. The prosthetic heart valve of any of the embodiments herein, particularly example 95, further comprising an inner skirt and / or an outer skirt mounted on the frame, the inner skirt and / or the outer skirt being secured to the extension portion with sutures.

[0267] Example 97. A prosthetic heart valve as described in any of the embodiments herein, particularly any one of embodiments 95-96, wherein the leaflet portions of the valve structure are secured to the extension portions with sutures.

[0268] Example 98. An artificial heart valve comprising: a radially expandable and compressible frame, the frame comprising: a plurality of pairs of axially extending frame members, each pair including a first frame member and a second frame member axially spaced from the first frame member, the pairs of frame members being circumferentially spaced from one another around a circumference of the frame, the first frame member of each pair including a cut-out area to receive a nut having internal threads; a plurality of threaded rods extending through respective pairs of first and second frame members, each including external threads that engage with the internal threads of a corresponding nut, such that rotation of the threaded rod in a first direction produces radial expansion of the frame from a radially compressed state to a radially expanded state; a valve structure disposed within the frame and configured to regulate unidirectional blood flow through the frame.

[0269] Example 99. A prosthetic heart valve as described in any of the embodiments herein, particularly example 98, wherein the frame further comprises a plurality of axially extending posts and a plurality of connecting struts, each post being circumferentially disposed between a pair of first and second frame members, and the connecting struts coupling the posts to the pair of frame members.

[0270] Example 100. A prosthetic heart valve as described in any embodiment herein, particularly embodiment 99, wherein each post is (i) connected to an adjacent first frame member of a first pair of adjacent frame members by two connecting struts, (ii) connected to an adjacent second frame member of the first adjacent pair by two connecting struts, (iii) connected to an adjacent first frame member of a second pair of adjacent frame members by two connecting struts, and (iv) connected to an adjacent second frame member of a second adjacent pair by two connecting struts.

[0271] Example 101. A prosthetic heart valve described in any of the embodiments herein, particularly any one of embodiments 99-100, wherein each connecting strut has a concavely curved portion and a convexly curved portion separated by an inflection point.

[0272] Example 102. A prosthetic heart valve described in any of the embodiments herein, particularly any one of embodiments 99-101, wherein the struts, posts, and first and second frame members are arranged to form a plurality of hexagonal cells and a plurality of diamond-shaped cells, each diamond-shaped cell being disposed within one of the hexagonal cells.

[0273] Example 103 A prosthetic heart valve as described in any of the embodiments herein, particularly example 102, wherein each diamond-shaped cell is centrally disposed within a respective hexagonal cell.

[0274] Example 104. A prosthetic heart valve as described in any of the embodiments herein, particularly any one of embodiments 102-103, wherein each hexagonal cell defines an inflow apex of the frame and an outflow apex of the frame.

[0275] Example 105. The prosthetic heart valve of any of the embodiments herein, particularly any one of Examples 102-104, wherein there are exactly six hexagonal cells and exactly six diamond shaped cells.

[0276] Example 106 The prosthetic heart valve of any of the embodiments herein, particularly any one of embodiments 102-105, wherein the hexagonal cells extend the entire length of the frame.

[0277] Example 107. A prosthetic heart valve as described in any of the embodiments herein, particularly any one of embodiments 98 to 106, wherein the valve structure comprises a plurality of leaflets, each leaflet having two commissure tabs on either side of the leaflet, each commissure tab pairing with an adjacent commissure tab of an adjacent leaflet to form a commissure, and each commissure being fixed to an adjacent post.

[0278] Example 108. A prosthetic heart valve according to any of the embodiments herein, particularly example 107, wherein each post adjacent a commissure has a slot, and a pair of commissure tabs of the adjacent commissures extend through the slots.

[0279] Example 109. A delivery device comprising: One or more actuator assemblies extending from the handle, each actuator assembly comprising: An outer sleeve; an actuation member extending through the outer sleeve and having a distal end portion configured to releasably couple to an actuator of a prosthetic heart valve, the distal end portion comprising: a driver head including an engagement member extending distally from a body of the driver head, the engagement member configured to extend into a corresponding recess in a head portion of the actuator; a gripper member comprising a plurality of arms configured to releasably couple to the head portion of the actuator, each of the plurality of arms comprising a distal end portion having teeth extending radially inwardly toward a longitudinal axis of the actuation member, each arm having an arcuate cross-sectional shape; A delivery device, wherein rotation of the actuating member in a first direction radially expands the prosthetic heart valve and rotation of the actuating member in a second direction radially compresses the prosthetic heart valve.

[0280] Example 110 The delivery device of any embodiment herein, particularly example 109, wherein the distal end of the outer sleeve comprises first and second support extensions.

[0281] Example 111. A delivery device as described in any of the embodiments herein, particularly example 110, wherein the first support extension is configured to extend partially onto the radially inner surface of the prosthetic valve and the second support extension is configured to extend partially onto the radially outer surface of the prosthetic valve to inhibit rotation of the frame of the prosthetic valve relative to the actuator assembly.

[0282] Example 112. A delivery device described in any of the embodiments herein, particularly any one of embodiments 109-111, wherein the multiple arms are movable between an extended position and a compressed position.

[0283] Example 113. A delivery device as described in any of the embodiments herein, particularly embodiment 112, wherein the multiple arms are configured to bias radially outward away from the longitudinal axis of the actuation member.

[0284] Example 114 The delivery device of any of the embodiments herein, particularly any one of embodiments 109-113, wherein the engagement member comprises a square shape in cross section.

[0285] Example 115. A delivery device described in any of the embodiments herein, particularly any one of embodiments 109 to 114, wherein the engagement member has one or more surfaces configured to engage with corresponding surfaces of a corresponding recess in the head portion of the actuator.

[0286] Example 116. A delivery device described in any of the embodiments herein, particularly any one of embodiments 109-115, wherein the driver head comprises one or more protrusions extending radially outward from the driver head.

[0287] Example 117. A delivery device as described in any embodiment herein, particularly embodiment 116, wherein when the multiple arms are in the compressed position, one or more protrusions are disposed between adjacent arms.

[0288] Example 118. A delivery device described in any of the embodiments herein, particularly any one of embodiments 116-117, wherein the protrusion has a rectangular prism shape with chamfered side edges.

[0289] Example 119. A delivery device described in any of the embodiments herein, particularly any one of embodiments 116-118, wherein the one or more protrusions include four protrusions spaced apart from one another around the circumference of the driver head.

[0290] Example 120. A delivery device described in any of the embodiments herein, particularly any one of embodiments 109-119, wherein the gripper member comprises an annular base member and a plurality of arms extend distally from the annular base member.

[0291] Example 121 A delivery device described in any embodiment herein, particularly any one of embodiments 109-120, wherein the multiple arms and outer sleeve form a collet.

[0292] Example 122. A delivery device described in any embodiment herein, particularly any one of embodiments 109-121, wherein each tooth has an angled proximal surface.

[0293] Example 123. A delivery device described in any of the embodiments herein, particularly any one of embodiments 109-122, wherein the distal end portion of each arm expands radially outward such that the distal end portion is radially thicker than the body of the arm.

[0294] Example 124. A delivery device according to any of the embodiments herein, particularly any one of embodiments 109-123, wherein the plurality of arms consists of four arms.

[0295] Example 125 A delivery device described in any of the embodiments herein, particularly any one of embodiments 109-124, wherein the distal end portion of each arm has an increased circumferential width relative to the body of the arm.

[0296] Example 126. An assembly comprising: 1. A prosthetic heart valve comprising: a radially expandable and compressible frame including an inlet end portion and an outlet end portion; a prosthetic heart valve having one or more actuators having a body and a head portion, the actuators configured to radially expand the frame upon rotation of the one or more actuators, the head portion comprising a central recess and a circumferentially extending recess; 1. A delivery device comprising: A handle and one or more actuator assemblies extending from the handle, each actuator assembly including an outer sleeve and an actuating member extending through the outer sleeve, the actuating member including: a driver head including an engagement member extending distally from a body of the driver head that extends into a central recess of each actuator; a gripper member comprising a plurality of arms configured to releasably couple to the head portion of the respective actuator, each of the plurality of arms comprising a distal end portion having teeth extending into the circumferential recess of the respective actuator; An assembly, wherein rotation of the actuating member in a first direction radially expands the prosthetic heart valve and rotation of the actuating member in a second direction radially compresses the prosthetic heart valve.

[0297] Example 127 The assembly of any embodiment herein, especially example 126, wherein the central recess comprises a square shape in cross-section.

[0298] Example 128. The delivery device of any of the embodiments herein, particularly any one of embodiments 126-127, wherein the engagement member comprises a square shape in cross section.

[0299] Example 129. The assembly described in any of the embodiments herein, particularly any one of embodiments 126-128, wherein the engagement member comprises one or more surfaces configured to engage with corresponding surfaces in the central recess.

[0300] Example 130. An assembly described in any of the embodiments herein, particularly any one of embodiments 126-129, wherein the circumferential recess extends circumferentially around the head portion and includes an angled proximal surface.

[0301] Example 131. An assembly described in any of the embodiments herein, particularly any one of embodiments 126-130, wherein each tooth includes an angled proximal surface that corresponds to the angled proximal surface of the circumferential recess.

[0302] Example 132. The assembly described in any of the embodiments herein, particularly any one of embodiments 126-131, wherein the distal end of the outer sleeve includes first and second support extensions.

[0303] Example 133. An assembly as described in any of the embodiments herein, particularly example 132, wherein the first support extension is configured to extend partially onto the radially inner surface of the prosthetic valve and the second support extension is configured to extend partially onto the radially outer surface of the prosthetic valve to inhibit rotation of the frame of the prosthetic valve relative to the actuator assembly.

[0304] Example 134. The assembly of any of the embodiments herein, particularly any one of embodiments 126-133, wherein the arms are movable between an extended position and a compressed position.

[0305] Example 135. The assembly of any example herein, particularly example 134, wherein the multiple arms are configured to bias radially outwardly away from the longitudinal axis of the actuation member.

[0306] Example 136. The assembly described in any of the embodiments herein, particularly any one of embodiments 126-135, wherein the driver head comprises one or more protrusions extending radially outward from the driver head.

[0307] Example 137. The assembly of any embodiment herein, especially example 136, wherein when the arms are in the compressed position, one or more protrusions are disposed between adjacent arms.

[0308] Example 138. The assembly of any of the embodiments herein, particularly any one of embodiments 136-137, wherein the protrusion comprises a rectangular prism shape having chamfered side edges.

[0309] Example 139. The assembly of any one of claims 136 to 138, wherein the one or more protrusions include four protrusions spaced apart from one another around a circumference of the driver head.

[0310] Example 140. An assembly described in any of the embodiments herein, particularly any one of embodiments 126-139, wherein the gripper member comprises an annular base member and a plurality of arms extend distally from the annular base member.

[0311] Example 141. The assembly of any embodiment herein, particularly any one of embodiments 126-140, wherein the plurality of arms and the outer sleeve form a collet.

[0312] Example 142. An assembly described in any of the embodiments herein, particularly any one of embodiments 126-141, wherein the distal end portion of each arm flares radially outward such that the distal end portion is radially thicker than the main body of the arm.

[0313] Example 143. The assembly of any embodiment herein, particularly any one of embodiments 126-142, wherein the plurality of arms consists of four arms.

[0314] Example 144. An assembly described in any embodiment herein, particularly any one of embodiments 126-143, wherein the distal end portion of each arm has an increased circumferential width relative to the body of the arm.

[0315] Example 145. An assembly described in any of the examples herein, particularly any one of examples 126-145, wherein the frame includes multiple pairs of axially extending frame members, each pair of frame members including a first frame member and a second frame member axially spaced from the first frame member, and one or more actuators each extend through a respective pair of frame members.

[0316] Example 146. The assembly of any example herein, especially example 145, wherein the pair of frame members are circumferentially spaced apart from one another around the circumference of the frame.

[0317] Example 147. A method comprising: advancing an actuation member of an actuator assembly of a delivery device axially relative to an actuator of a radially expandable and compressible prosthetic valve such that a plurality of arms of the actuation member are advanced over a head portion of the actuator, the head portion comprising a central recess and a circumferential recess; continuing to advance the actuation member such that teeth extending radially inward from the plurality of arms are disposed within the circumferential recesses and an engagement member extending distally from the actuation member is disposed within the central recess; and advancing an outer sleeve of the actuator assembly over the actuation member such that the plurality of arms are radially compressed, thereby retaining the tines within the circumferential recesses and coupling the actuator assembly to the prosthetic valve.

[0318] Example 148. A delivery device comprising: One or more actuator assemblies extending from the handle, each actuator assembly comprising: An outer sleeve; an actuation member extending through the outer sleeve and having a distal end portion configured to releasably couple to an actuator of a prosthetic heart valve, the distal end portion comprising: a driver head comprising an engagement member extending distally from a body of the driver head, the engagement member configured to extend into a corresponding recess in a head portion of the actuator, the engagement member comprising one or more surfaces configured to engage corresponding surfaces of the corresponding recess; a gripper member comprising a plurality of arms configured to releasably couple to the head portion of the actuator, each of the plurality of arms comprising a distal end portion having teeth extending radially inwardly toward a longitudinal axis of the actuation member, the distal end portion of each arm having an increased circumferential width relative to a body of the arm; A delivery device, wherein rotation of the actuation member in a first direction radially expands the prosthetic valve and rotation of the actuation member in a second direction radially compresses the prosthetic valve.

[0319] Example 148. An implantable prosthetic device comprising: a radially expandable and compressible frame having an inlet end portion and an outlet end portion, the frame comprising: A plurality of posts, one or more of which: a first frame member having a first internal aperture; a second frame member having a second internal bore, the first and second frame members being axially spaced from one another; and a plurality of posts configured as an actuation mechanism comprising: an actuator having an externally threaded surface and extending through the first and second internal holes, the actuator comprising a body and a head portion, the head portion comprising a circumferential recess; a plurality of struts connecting adjacent posts to one another; A prosthetic device, wherein rotation of an actuator in a first direction causes axial movement of the first and second frame members toward one another to radially expand the prosthetic device.

[0320] Example 149 The implantable prosthetic device of any embodiment herein, particularly example 148, wherein the circumferential recess comprises an angled proximal surface.

[0321] Example 150 The implantable prosthetic device of any embodiment herein, particularly any one of embodiments 148-149, wherein the head portion further comprises a central recess.

[0322] Example 151. The implantable prosthetic device of any of the embodiments herein, particularly embodiment 150, wherein the central recess comprises one or more surfaces configured to engage corresponding surfaces on an actuation assembly of the delivery device.

[0323] Example 152 The implantable prosthetic device according to any of the embodiments herein, particularly any one of embodiments 150-151, wherein the central recess has a square shape in cross section.

[0324] Example 153. A delivery device comprising: One or more actuator assemblies extending from the handle, each actuator assembly comprising: an outer sleeve including first and second support extensions extending from a distal end portion thereof; an actuation member extending through the outer sleeve and having a distal engagement portion configured to releasably couple to an actuator of a prosthetic heart valve, the distal engagement portion comprising: a driver head including an engagement element configured to engage a corresponding engagement element in a head portion of the actuator; a gripper member including a plurality of arms configured to removably couple to the head portion of the actuator, each of the plurality of arms including a first proximal end portion and a second distal end portion, the distal end portions having a circumferential width greater than a circumferential width of the proximal end portions, and each arm having an arcuate cross-sectional shape; A delivery device, wherein rotation of the actuating member in a first direction radially expands the prosthetic heart valve and rotation of the actuating member in a second direction radially compresses the prosthetic heart valve.

[0325] Example 154. A delivery device as described in any of the embodiments herein, particularly example 153, wherein the driver head engagement element comprises a protrusion extending distally from the body of the driver head, the protrusion having a square shape in cross section.

[0326] Example 155. A delivery device as described in any embodiment herein, particularly example 154, wherein the engagement element of the head portion of the actuator has a corresponding recess and the driver head engagement element has one or more surfaces configured to engage with corresponding surfaces in the corresponding recess.

[0327] Example 156. A delivery device described in any of the embodiments herein, particularly any one of embodiments 153 to 155, wherein the driver head has one or more protrusions extending radially outward from the driver head such that when the arms are in a compressed position, the one or more protrusions are positioned between adjacent arms.

[0328] Example 157 A delivery device as described in any of the embodiments herein, particularly example 156, wherein the protrusion comprises a rectangular prism shape having chamfered side edges.

[0329] Example 158. A delivery device described in any of the embodiments herein, particularly any one of embodiments 153 to 157, wherein the multiple arms and outer sleeve together form a collet.

[0330] Example 159. A delivery device described in any of the embodiments herein, particularly any one of embodiments 153 to 158, wherein each arm has teeth extending radially inward toward the longitudinal axis of the actuation member, and each tooth has an angled proximal surface.

[0331] Example 160. A delivery device described in any of the embodiments herein, particularly any one of embodiments 153-159, wherein the distal end portion of each arm flares radially outward such that the distal end portion is radially thicker than the body of the arm.

[0332] Example 161 A delivery device as described in any of the embodiments herein, particularly example 153, wherein the driver head engagement element comprises a recess having a semicircular shape in cross section.

[0333] Example 162. A delivery device as described in any of the embodiments herein, particularly example 161, wherein the engagement element of the head portion of the actuator comprises a corresponding Ω-shaped protrusion configured to be at least partially disposed within the recess.

[0334] Example 163. A delivery device described in any of the embodiments herein, particularly any one of embodiments 161-162, wherein each arm has a uniform thickness from the proximal end portion to the distal end portion.

[0335] Example 164. A delivery device described in any of the embodiments herein, particularly any one of embodiments 153 to 163, wherein a portion of the outer sleeve comprises a hypotube configured to be axially expandable and compressible between a first length and a second length.

[0336] Example 165 A delivery device as described in any of the embodiments herein, particularly example 164, wherein the hypotube comprises a plurality of diamond-shaped slots extending at least partially around the circumference of the outer sleeve.

[0337] Example 166. A delivery device comprising: One or more actuator assemblies extending from the handle, each actuator assembly comprising: An outer sleeve; an actuation member extending through the outer sleeve and having a distal end portion configured to releasably couple to an actuator of a prosthetic heart valve, the distal end portion comprising: a driver head including an engagement member extending distally from a body of the driver head, the engagement member configured to extend into a corresponding recess in a head portion of the actuator, the driver head including one or more protrusions extending radially therefrom; an actuation member having a gripper member including a plurality of arms configured to removably couple to the head portion of the actuator, each of the plurality of arms including a distal end portion having teeth extending radially inwardly toward a longitudinal axis of the actuation member, each arm having an arcuate cross-sectional shape; A delivery device, wherein rotation of the actuating member in a first direction radially expands the prosthetic heart valve and rotation of the actuating member in a second direction radially compresses the prosthetic heart valve.

[0338] Example 167. A delivery device as described in any of the embodiments herein, particularly example 166, wherein the distal end of the outer sleeve has first and second support extensions, the first support extension configured to extend partially onto a radially inner surface of the prosthetic valve, and the second support extension configured to extend partially onto a radially outer surface of the prosthetic valve to inhibit rotation of the frame of the prosthetic valve relative to the actuator assembly.

[0339] Example 168. A delivery device described in any of the embodiments herein, particularly any one of embodiments 166-167, wherein when the multiple arms are in a compressed position, one or more protrusions are disposed between adjacent arms.

[0340] Example 169. A delivery device comprising: One or more actuator assemblies extending from the handle, each actuator assembly comprising: An outer sleeve; an actuation member extending through the outer sleeve and having a distal end portion configured to releasably couple to an actuator of a prosthetic heart valve, the distal end portion comprising: a driver head including an engagement recess extending proximally into a body of the driver head, the engagement recess configured to receive a portion of a corresponding engagement member of a head portion of the actuator, the driver head including one or more shoulders extending radially from the driver head, each shoulder including a notch configured to receive a portion of the corresponding engagement member; an actuation member having a gripper member comprising a plurality of arms configured to releasably couple to the head portion of the actuator, each of the plurality of arms having an arcuate cross-sectional shape, adjacent arms of each pair of the plurality of arms defining an Ω-shaped recess therebetween; A delivery device, wherein rotation of the actuating member in a first direction radially expands the prosthetic heart valve and rotation of the actuating member in a second direction radially compresses the prosthetic heart valve.

[0341] Example 170. A delivery device as described in any of the embodiments herein, particularly example 169, wherein the engagement member of the head portion of the actuator has an Ω-shaped protrusion configured to be at least partially disposed within the engagement recess and within one or more of the Ω-shaped recesses of the gripper member.

[0342] Example 171. A delivery device described in any of the embodiments herein, particularly any one of embodiments 169-170, wherein each arm has a uniform thickness from the proximal end portion to the distal end portion.

[0343] Example 172. A delivery device described in any of the embodiments herein, particularly any one of embodiments 169 to 171, wherein each arm of the multiple arms has a neck portion having a first circumferential width and a distal end portion having a second circumferential width greater than the first circumferential width.

[0344] In view of the many possible examples to which the principles of this disclosure may be applied, it will be recognized that the illustrated examples are merely preferred examples and should not be viewed as limiting the scope of the disclosure. Rather, the scope of the disclosure is defined by the following claims. We therefore claim all that comes within the scope and spirit of those claims.

Claims

1. 1. A delivery device comprising: One or more actuator assemblies extending from the handle, each actuator assembly comprising: an outer sleeve including first and second support extensions extending from a distal end portion thereof; an actuation member extending through the outer sleeve and having a distal engagement portion configured to releasably couple to an actuator of a prosthetic heart valve, the distal engagement portion comprising: a driver head including an engagement element configured to engage a corresponding engagement element in a head portion of the actuator; a gripper member comprising a plurality of arms configured to removably couple to the head portion of the actuator, each of the plurality of arms comprising a first proximal end portion and a second distal end portion, the distal end portions having a circumferential width greater than a circumferential width of the proximal end portions, each arm having an arcuate cross-sectional shape; A delivery device, wherein rotation of the actuating member in a first direction radially expands the prosthetic heart valve and rotation of the actuating member in a second direction radially compresses the prosthetic heart valve.

2. The delivery device of claim 1 , wherein the driver head engagement element comprises a protrusion extending distally from a body of the driver head, the protrusion having a square shape in cross section.

3. 3. The delivery device of claim 2, wherein the engagement element of the head portion of the actuator comprises a corresponding recess, and the driver head engagement element comprises one or more surfaces configured to engage corresponding surfaces in the corresponding recess.

4. 4. The delivery device of claim 1, wherein the driver head comprises one or more protrusions extending radially outward from the driver head such that the one or more protrusions are disposed between adjacent arms when the arms are in a compressed position.

5. The delivery device of claim 4 , wherein the protrusion comprises a rectangular prism shape having chamfered side edges.

6. The delivery device of any one of claims 1 to 5, wherein the plurality of arms and the outer sleeve together form a collet.

7. A delivery device according to any preceding claim, wherein each arm comprises a tooth extending radially inwardly towards a longitudinal axis of the actuation member, each tooth comprising an angled proximal surface.

8. A delivery device according to any preceding claim, wherein a distal end portion of each arm flares radially outwardly such that the distal end portion is radially thicker than the body of the arm.

9. The delivery device of claim 1 , wherein the driver head engagement element comprises a recess having a semicircular shaped cross-section.

10. The delivery device of claim 9 , wherein the engagement element of the head portion of the actuator comprises a corresponding Ω-shaped protrusion configured to be at least partially disposed within the recess.

11. A delivery device according to any one of claims 9 to 10, wherein each arm has a uniform thickness from the proximal end portion to the distal end portion.

12. 12. The delivery device of any one of claims 1-11, wherein a portion of the outer sleeve comprises a hypotube configured to be axially expandable and compressible between a first length and a second length.

13. The delivery device of claim 12 , wherein the hypotube comprises a plurality of diamond shaped slots extending at least partially around a circumference of the outer sleeve.

14. 1. A delivery device comprising: One or more actuator assemblies extending from the handle, each actuator assembly comprising: An outer sleeve; an actuation member extending through the outer sleeve and having a distal end portion configured to releasably couple to an actuator of a prosthetic heart valve, the distal end portion comprising: a driver head including an engagement member extending distally from a body of the driver head, the engagement member configured to extend into a corresponding recess in a head portion of the actuator, the driver head including one or more protrusions extending radially therefrom; a gripper member comprising a plurality of arms configured to releasably couple to the head portion of the actuator, each of the plurality of arms comprising a distal end portion having teeth extending radially inwardly toward a longitudinal axis of the actuation member, each arm having an arcuate cross-sectional shape; A delivery device, wherein rotation of the actuating member in a first direction radially expands the prosthetic heart valve and rotation of the actuating member in a second direction radially compresses the prosthetic heart valve.

15. 15. The delivery device of claim 14, wherein a distal end of the outer sleeve comprises first and second support extensions, the first support extension configured to extend partially onto a radially inner surface of the prosthetic valve and the second support extension configured to extend partially onto a radially outer surface of the prosthetic valve to inhibit rotation of the prosthetic valve relative to the actuator assembly.

16. A delivery device according to any one of claims 14 to 15, wherein the one or more protrusions are disposed between adjacent arms when the arms are in a compressed position.

17. 1. A delivery device comprising: One or more actuator assemblies extending from the handle, each actuator assembly comprising: An outer sleeve; an actuation member extending through the outer sleeve and having a distal end portion configured to releasably couple to an actuator of a prosthetic heart valve, the distal end portion comprising: a driver head including an engagement recess extending proximally into a body of the driver head, the engagement recess configured to receive a portion of a corresponding engagement member of a head portion of the actuator, the driver head including one or more shoulders extending radially from the driver head, each shoulder including a notch configured to receive a portion of the corresponding engagement member; a gripper member comprising a plurality of arms configured to releasably couple to the head portion of the actuator, each of the plurality of arms having an arcuate cross-sectional shape, adjacent arms of each pair of the plurality of arms defining an Ω-shaped recess therebetween; A delivery device, wherein rotation of the actuating member in a first direction radially expands the prosthetic heart valve and rotation of the actuating member in a second direction radially compresses the prosthetic heart valve.

18. 20. The delivery device of claim 17, wherein the engagement member of the head portion of the actuator comprises an Ω-shaped protrusion configured to be at least partially disposed within the engagement recess and within one or more of the Ω-shaped recesses of the gripper member.

19. A delivery device according to any one of claims 17 to 18, wherein each arm has a uniform thickness from the proximal end portion to the distal end portion.

20. 20. The delivery device of any one of claims 17 to 19, wherein each arm of the plurality of arms has a neck portion having a first circumferential width and a distal end portion having a second circumferential width greater than the first circumferential width.

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