Delivery device for mechanically expandable valves

Abstract

A 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 with an engagement portion configured to releasably couple an actuator of a prosthetic heart valve. The engagement portion may include: a driver head including an engagement element configured to engage with a corresponding engagement element in a head portion of the actuator; and a gripper member, the gripper member including a plurality of arms, the plurality of arms configured to releasably couple the head portion of the actuator. Each arm may have a distal end portion having a circumferential width greater than a circumferential width of the proximal end portion, and each arm may have 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

[0001] Cross-reference to related applications

[0002] This application claims the benefit of U.S. Application No. 63 / 325,525, filed on March 30, 2022, which is incorporated herein by reference in its entirety. Technical Field

[0003] The present disclosure relates to implantable mechanically expandable prosthetic devices, such as prosthetic heart valves, and methods and delivery assemblies for and involving such prosthetic devices. Background Art

[0004] The human heart may suffer from various valvular diseases. These valvular diseases may cause significant dysfunction of the heart, and ultimately require repairing the natural valve or replacing the natural valve with an artificial valve. There are many known repair devices (e.g., stents) and artificial valves, as well as many known methods for implanting these devices and valves into the human body. Percutaneous and minimally invasive surgical methods are used in various surgeries to deliver prosthetic medical devices to a position that is not easily accessible by surgery or a position that is expected to be accessible without surgery. In a specific example, a prosthetic heart valve can be mounted on the distal end of a delivery device in a curled state, and advance through the patient's vascular system (e.g., through the femoral artery and aorta) until the prosthetic heart valve reaches the implantation site in the heart. The prosthetic heart valve is then expanded to its functional size, for example, by inflating the balloon on which the prosthetic valve is mounted, actuating a mechanical actuator that applies an expansion force to the prosthetic heart valve, or by unfolding the prosthetic heart valve from the sheath of the delivery device so that the prosthetic heart valve can be self-expanded to its functional size.

[0005] 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 self-expanding and balloon-expandable prosthetic heart valves. 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 after initial expansion (e.g., for repositioning and / or removal). However, some known devices and methods may cause rotation or movement of the prosthetic valve during expansion.

[0006] Despite recent advances in percutaneous valve technology, there remains a need for improved transcatheter heart valves and delivery devices for such valves. Summary of the invention

[0007] Prosthetic heart valves, delivery devices, and methods for implanting prosthetic heart valves are described herein. For example, the disclosed prosthetic heart valves, delivery devices, and methods can allow the delivery device to radially expand the prosthetic heart valve at a selected implantation site. Thus, the devices and methods disclosed herein can overcome one or more deficiencies of typical prosthetic heart valves and their delivery devices, among other things.

[0008] A delivery device for a prosthetic implant may include a handle and one or more shafts coupled to the handle.

[0009] In some examples, the delivery device can include one or more actuator assemblies extending from the handle and configured to couple to one or more actuators that actuate the prosthetic heart valve to radially expand and radially compress the prosthetic heart valve.

[0010] In some examples, the actuator assemblies can each include a driver and an outer sleeve. In some examples, the driver can have an engagement portion including a driver head and a gripper member.

[0011] In some instances, the outer sleeve can include one or more support extensions that extend partially over a radially inner surface or a radially outer surface of the frame, the support extensions being configured to inhibit rotation of the frame relative to the one or more actuator assemblies during expansion or compression of the prosthetic valve.

[0012] In some examples, the gripper member includes a plurality of arms configured to releasably couple to a head portion of an actuator of a prosthetic valve. In some examples, a distal portion of each arm includes a tooth extending radially inward, each tooth including an angled proximal surface. In some examples, a thickness of each arm is uniform from a proximal portion to a distal portion of the arm.

[0013] In a representative example, the delivery device may include one or more actuator assemblies extending from a handle. Each actuator assembly may include an outer sleeve and an actuating member extending through the outer sleeve and having a distal portion, the distal portion being configured to releasably couple an actuator of a prosthetic heart valve. The distal portion may include: a driver head, the driver head including an engagement member extending distally from a body of the driver head, the engagement member being configured to extend into a corresponding recess in the head portion of the actuator; and a clamp member, the clamp member including a plurality of arms, the plurality of arms being configured to releasably couple the head portion of the actuator. The plurality of arms may each include a distal portion having teeth extending radially inwardly toward a longitudinal axis of the actuating member, and each arm may have an arcuate cross-sectional shape. 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 a representative example, an 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 being configured to radially expand the frame when the one or more actuators are rotated, 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 portion. The distal portion may include: a driver head, the driver head including an engagement member, the engagement member extending distally from the body of the driver head, the engagement member extending into the central recess of the corresponding actuator; and a clamp member, the clamp member including a plurality of arms, the plurality of arms being configured to releasably couple the head portion of the corresponding actuator, the plurality of arms each including a distal portion, the distal portion having teeth extending into the circumferential recess of the corresponding actuator. 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.

[0015] In a representative example, a method may include advancing an actuating member of an actuator assembly of a delivery device axially relative to an actuator of a radially expandable and compressible prosthetic valve, so that a plurality of arms of the actuating member advance over a head portion of the actuator, the head portion comprising a central recess and a circumferential recess. The method may further include continuing to advance the actuating member so that teeth extending radially inward from the plurality of arms are disposed within the circumferential recess, and so that an engagement member extending distally from the actuating member is disposed within the central recess; and advancing an outer sleeve of the actuator assembly over the actuating member so that the plurality of arms are radially compressed, thereby retaining the teeth within the circumferential recess, and coupling the actuator assembly to the prosthetic valve.

[0016] In another representative example, the delivery device may include 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 and having a distal portion, the distal portion being configured to releasably couple an actuator of a prosthetic heart valve. The distal portion may include: a driver head, the driver head including an engagement member extending distally from the body of the driver head, the engagement member being configured to extend into a corresponding recess in the head portion of the actuator, the engagement member including one or more facets, the one or more facets being configured to engage with corresponding facets in the corresponding recess; and a clamp member, the clamp member including a plurality of arms, the plurality of arms being configured to releasably couple the head portion of the actuator, the plurality of arms each including a distal portion having teeth extending radially inwardly toward the longitudinal axis of the actuating member, the distal 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.

[0017] In a representative example, 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 columns, one or more of which are configured as an actuation mechanism, the actuation mechanism comprising a first frame member having a first inner hole, a second frame member having a second inner hole, the first frame member and the second frame member being axially spaced from each other; an actuator; and a plurality of struts that couple adjacent columns to each other. The actuator may have an external threaded surface and may extend through the first inner hole and the second inner hole. 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 axial movement of the first frame member and the second frame member toward each other to radially expand the prosthetic device.

[0018] The various innovations of the present disclosure may be used in combination or alone. The present disclosure is provided to introduce a series of concepts further described in the following specific embodiments in a simplified form. The present disclosure is not intended to identify the 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 foregoing and other objects, features and advantages of the present disclosure will become more apparent from the following specific embodiments, claims and drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Figure 1 is a perspective view of a prosthetic heart valve according to one embodiment.

[0020] Figure 2 is a side elevation view of a delivery apparatus for a prosthetic heart valve according to one example.

[0021] Figure 3 is a perspective view of a frame of a prosthetic heart valve including multiple actuator mechanisms, one of which is shown as an actuator assembly coupled to a delivery device, according to one example.

[0022] Figure 4 yes Figure 3 A perspective view of an actuator mechanism and a portion of an actuator assembly.

[0023] Figure 5 yes Figure 4 A perspective view of an actuator mechanism and a portion of an actuator assembly.

[0024] Figure 6 yes Figure 4 A perspective view of an actuator mechanism and a portion of an actuator assembly with the outer sleeve shown transparently.

[0025] Figure 7 yes Figure 4 A perspective view of an actuator mechanism and a portion of an actuator assembly.

[0026] Figure 8 yes Figure 3 A perspective view of a portion of a frame and actuator assembly shown coupled together.

[0027] Fig. 9 yes Figure 3 A perspective view of a portion of a frame and actuator assembly shown coupled together with the outer sleeve shown transparently.

[0028] Fig.10 yes Figure 3 A perspective view of a portion of a frame and actuator assembly shown coupled together.

[0029] Fig.11 yes Figure 3 A partial cross-sectional view of a portion of a frame and actuator assembly shown coupled together.

[0030] Fig.12 is a perspective view of a prosthetic heart valve according to one embodiment.

[0031] Fig.13 yes Fig.12 A perspective view of a portion of a frame of a prosthetic heart valve.

[0032] Fig.14 yes Fig.12 Schematic top view of a prosthetic heart valve.

[0033] Fig.15 is a perspective view of a threaded rod of an actuator mechanism according to one example.

[0034] Fig.16 yes Fig.15 A side elevation view of a portion of a threaded rod.

[0035] Fig.17 yes Fig.15 An end view of a portion of a threaded rod.

[0036] Fig.18 is a perspective view of a portion of an outer sleeve of an actuator assembly according to one example.

[0037] Fig.19 is a perspective view of a portion of a driver of an actuator assembly according to one example.

[0038] Fig. 20 yes Fig.19 A perspective view of the drive head of a drive.

[0039] Fig.21 yes Fig.19 A perspective view of a holder member of a drive.

[0040] Figure 22-25 A perspective view of an exemplary method for decoupling an actuator assembly from an actuator mechanism of a prosthetic heart valve is shown according to one example.

[0041] Figure 26-28 Shown Figure 22-25 A cross-sectional side elevation view of an exemplary method for decoupling an actuator assembly.

[0042] 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 example.

[0043] Figure 30-32 Demonstrated for Fig.29 A perspective view of an exemplary method of decoupling an actuator assembly from an actuator mechanism of a prosthetic heart valve.

[0044] Figure 33-35 Shown Figure 30-32 A cross-sectional view of an exemplary method for decoupling an actuator assembly.

[0045] 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 example.

[0046] Fig.37 is a perspective view of a driver head of a driver of an actuator assembly according to one example.

[0047] Fig.38 is a perspective view of a gripper member of a driver of an actuator assembly according to one example.

[0048] Fig.39 According to one embodiment, a prosthetic heart valve comprises Fig.36 An exemplary frame portion of a threaded rod and comprising Figure 37-38 A perspective view of a portion of an actuator assembly of a driver head and a gripper member.

[0049] Fig.40 Based on an example Fig.39 of Fig.39 A perspective view of an actuator assembly coupled to a portion of an exemplary prosthetic heart valve frame.

[0050] Fig.41 Based on an example Fig.39 of Fig.39 A cross-sectional view of an actuator assembly coupled to a portion of an exemplary prosthetic heart valve frame.

[0051] Fig.42 is a perspective view of a hypotube portion of an outer sleeve of an actuator assembly according to one example.

[0052] Fig.43 is based on an example including Fig.42 A perspective view of an actuator assembly with a hypotube portion coupled to a portion of an exemplary prosthetic valve frame.

[0053] Fig.44 Based on an example Fig.43 of Fig.43 0026] A cross-sectional view of an actuator assembly coupled to a prosthetic heart valve frame, with the outer sleeve shown transparently for illustrative purposes.

[0054] Fig.45 Yes Fig.42 A side elevation view of a portion of an outer sleeve of an actuation assembly of a hypotube portion of FIG. 1 , showing the hypotube in an expanded configuration.

[0055] Fig.46 yes Fig.45 A side elevation view of a portion of the outer sleeve showing the hypotube in a compressed configuration. DETAILED DESCRIPTION

[0056] General considerations

[0057] For the purposes of this description, certain aspects, advantages, and novel features of examples of the present disclosure are described herein. The disclosed methods, devices, and systems should not be construed as limiting in any way. Rather, the present disclosure relates to all novel and non-obvious features and aspects of the various disclosed examples, individually and in various combinations and sub-combinations with each other. The methods, devices, and systems are not limited to any particular aspect or feature or combination thereof, nor do the disclosed examples require the presence of any one or more specific advantages or solutions to problems.

[0058] Although the operations of some of the disclosed examples are described in a particular sequential order for ease of presentation, it should be understood that this manner of description encompasses rearrangement unless the specific language set forth below requires a specific order. For example, in some cases, the operations described in sequence may be rearranged or performed simultaneously. In addition, for simplicity, the accompanying drawings may not show the various ways in which the disclosed methods can be used in conjunction with other methods. In addition, this specification sometimes uses terms such as "providing" or "implementing" to describe the disclosed methods. These terms are high-level abstractions of the actual operations performed. The actual operations corresponding to these terms may vary depending on the specific implementation and are easily discernible by a person of ordinary skill in the art.

[0059] All features described herein are independent of each other and can be used in combination with any other features described herein unless structurally impossible. Figure 2 The delivery device 100 shown can be used in combination with the prosthetic valve 200 or 400 described herein. Figure 3 The actuator mechanism 206 shown may be used with Fig.12 The prosthetic valve 400 and / or Figure 1 The prosthetic valve 10 is shown for use in combination.

[0060] As used in this application and claims, the singular forms "a," "an," and "the" include the plural forms unless the context clearly dictates otherwise. Additionally, the term "include" means "comprise." Further, the term "coupled" generally means a physical, mechanical, chemical, magnetic, and / or electrical connection or connection, and does not exclude the presence of intervening elements between the coupled or associated items absent specific language to the contrary.

[0061] As used herein, the term "proximal" refers to a device that is closer to the user and further away from the location, direction or part of the implantation site. As used herein, the term "distal" refers to a device that is further away from the user and closer to the location, direction or part of the implantation site. Therefore, for example, the proximal movement of the device is the movement of the device away from the implantation site and toward the user (e.g., leaving the patient's body), and the distal movement of the device is the movement of the device away from the user and toward the implantation site (e.g., entering the patient's body). The terms "longitudinal" and "axial" refer to the axis extending in the proximal and distal directions, unless otherwise clearly defined.

[0062] As used herein, "such as" means "for example," and "ie" means "that is to say."

[0063] Examples of the disclosed technology

[0064] Examples of prosthetic implants, such as prosthetic heart valves, that can be implanted in any of the natural valves of the heart (e.g., aortic valve, mitral valve, tricuspid valve, and pulmonary valve) are described herein. The present disclosure also provides a frame for use with such a prosthetic implant. The frame may further include an actuator mechanism (e.g., an expansion mechanism) and / or a locking mechanism to better control radial compression or expansion of the valve body. The frame may include struts of different shapes and / or sizes to minimize the overall curling profile of the implant and provide sufficient structural strength and rigidity for the required area.

[0065] The prosthetic valve disclosed herein can be radially compressed and expanded between a radially compressed state and a radially expanded state. Thus, during delivery, the prosthetic valve can be crimped on or held by an implant delivery device in a radially compressed state, and then once the prosthetic valve reaches the implantation site, the prosthetic valve is expanded to a radially expanded state. It should be understood that the valve disclosed herein can be used with a variety of implant delivery devices, and examples thereof will be discussed in more detail later.

[0066] Figure 1An exemplary prosthetic valve 10 according to one example is shown. The prosthetic valve 10 can include an annular stent or frame 12 having an inflow end 14 and an outflow end 16. The prosthetic valve 10 can also include a valve structure 18 coupled to and supported within the frame 12. The valve structure 18 is configured to regulate blood flow through the prosthetic valve 10 from the inflow end 14 to the outflow end 16.

[0067] The valve structure 18 may include, for example, a leaflet assembly including one or more leaflets 20 made of a flexible material. The leaflets 20 may be made in whole or in part of a biomaterial, a biocompatible synthetic material, or other such material. Suitable biomaterials may include, for example, bovine pericardium (or pericardium from other sources). The leaflets 20 may be fixed to each other at their adjacent sides to form commissures, each of which may be fixed to a corresponding actuator mechanism 50 or frame 12.

[0068] In the depicted example, the valve structure 18 includes three leaflets 20 that can be arranged to collapse in a tricuspid arrangement. Each leaflet 20 can have an inflow edge portion 22. Figure 1 As shown, the inflow edge portion 22 of the leaflet 20 can define an undulating curved scallop shape that circumferentially follows or tracks the plurality of interconnected strut segments of the frame 12 when the frame 12 is in the radially expanded configuration. The inflow edge of the leaflet can be referred to as a "scallop line."

[0069] In some instances, the inflow edge portion 22 of the leaflet 20 can be sutured to adjacent struts of the frame approximately along the scalloped line. In some instances, the inflow edge portion 22 of the leaflet 20 can be sutured to an inner skirt, which in turn is sutured to adjacent struts of the frame. By forming the leaflets 20 with such a scalloped geometry, the stress on the leaflets 20 is reduced, which in turn improves the durability of the valve 10. In addition, due to the scalloped shape, folds and corrugations at the belly of each leaflet 20 (the central area of ​​each leaflet) can be eliminated or at least minimized, which can lead to early calcification of these areas. The scalloped geometry also reduces the amount of tissue material used to form the valve structure 18, thereby allowing a smaller, more uniform curl profile at the inflow end 14 of the valve 10.

[0070] Additional details regarding transcatheter prosthetic heart valves, including manners in which the valve structure can be mounted to the frame of the prosthetic valve, can be found, for example, in U.S. Patent 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 herein by reference in their entirety.

[0071] The prosthetic valve 10 can be radially compressed and expanded between a radially compressed configuration and a radially expanded configuration. The frame 12 can include a plurality of interconnected lattice struts 24 arranged in a lattice-type pattern and forming a plurality of apexes 34 at the outflow end 16 of the prosthetic valve 10. The struts 24 can also form similar apexes 32 at the inflow end 14 of the prosthetic valve 10.

[0072] The struts 24 can be pivotally coupled to each other at one or more pivot joints or pivot junctions 28 along the length of each strut. For example, in one example, each of the struts 24 can be formed with apertures 30 at opposite ends of the struts, and the apertures can be spaced apart along the length of the struts. Respective hinges can be formed at locations where the struts 24 overlap each other by fasteners 38, such as rivets or pins extending through the apertures 30. The hinges can allow the struts 24 to pivot relative to each other when radially expanding or compressing the frame 12, such as during assembly, preparation, or implantation of the prosthetic valve 10.

[0073] The frame struts and components used to form the pivot joints of the frame 12 (or any frame described below) can be made of various suitable materials, such as stainless steel, cobalt-chromium alloys, or nickel-titanium alloys ("NiTi"), such as Nitinol. In some instances, the frame 12 can be constructed by forming separate components (e.g., the struts and fasteners of the frame), and then mechanically assembling and connecting the separate components together. Additional details regarding the construction of the frame and prosthetic valve are described in U.S. Patents Nos. 10,806,573, 10,603,165, 10,869,759, and 11,446,141, all of which are incorporated herein by reference in their entirety.

[0074] In the illustrated example, the prosthetic valve 10 can be mechanically expanded from a radially contracted configuration to a radially expanded configuration. For example, the prosthetic valve 10 can be radially expanded by maintaining the inflow end 14 of the frame 12 in a fixed position while applying a force to the outflow end 16 in an axial direction toward the inflow end 14. Alternatively, the prosthetic valve 10 can 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 end 14 and the outflow end 16, respectively.

[0075] like Figure 1 As shown, the prosthetic valve 10 can include one or more actuators 50 mounted to and equally spaced around the inner surface of the frame 12. Each of the actuators 50 can be configured to form a releasable connection with one or more corresponding actuators of a delivery device.

[0076] In the illustrated example, 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 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 junction between two struts. Each actuator 50 is configured to increase the distance between the attachment locations of the corresponding sleeve 54 and the nut 56, which causes the frame 12 to axially extend and radially compress, and is configured to decrease the distance between the attachment locations of the corresponding sleeve 54 and the nut 56, which causes the frame 12 to axially shorten and radially expand.

[0077] For example, each rod 52 may have an external thread that engages with an internal thread of a nut 56, so 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 the nut 56 to move closer to each other to radially expand the frame, or away from each other to radially compress the frame, depending on the direction of rotation of the rod 52.

[0078] In some examples, the actuator 50 can be a reciprocating actuator configured to apply an axial force to the frame to produce radial expansion and compression of the frame. For example, the rod 52 of each actuator can be axially fixed relative to the nut 56 and can be 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 will cause the frame to be radially compressed. In contrast, moving the rod 52 proximally relative to the sleeve 54 and / or moving the sleeve 54 distally relative to the rod 52 will cause the frame to be radially expanded.

[0079] When a reciprocating actuator is used, the prosthetic valve may also include one or more locking mechanisms that hold the frame in the expanded state. The locking mechanism may be a separate component mounted on the frame, spaced apart from the actuator, or a subassembly of the actuator itself.

[0080] Each rod 52 can include an attachment member 58 along a proximal portion of the rod 52 that is configured to form a releasable connection with a corresponding actuator of a delivery device. The actuator of the delivery device can apply a force to the rod to radially compress or expand the prosthetic valve 10. The attachment member 58 in the illustrated configuration includes a notch 60 and a protrusion 62 that can engage with a corresponding protrusion of the actuator of the delivery device.

[0081] In the example shown, the prosthetic valve 10 includes three such actuators 50, although a greater or lesser number of actuators may be used in other examples. The leaflet 20 may have a commissure attachment member 64 wrapped around a sleeve 54 of the actuator 50. Additional details of the actuator, locking mechanism, and delivery device for actuating the actuator may be found in U.S. Patents 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 actuator and locking mechanism disclosed in the previously submitted application may be incorporated into any prosthetic valve disclosed herein. Further, any delivery device disclosed in the previously submitted application may be used to deliver and implant any prosthetic valve disclosed herein.

[0082] The prosthetic valve 10 can include one or more skirts or sealing members. In some examples, the prosthetic valve 10 can include an inner skirt (not shown) mounted on the inner surface of the frame. The inner skirt can be used as a sealing member to prevent or reduce paravalvular leakage, to anchor the leaflets to the frame, and / or to protect the leaflets from damage caused by contact with the frame during crimping and during the working cycle of the prosthetic valve. Figure 1 As shown, the prosthetic valve 10 may also include an outer skirt 70 mounted on the outer surface of the frame 12. The outer skirt 70 can be used as a sealing member of the prosthetic valve by sealing the tissue of the natural valve ring and helping to reduce paravalvular leakage through the prosthetic valve. The inner skirt and the outer skirt can be formed of any of a variety of suitable biocompatible materials, including various synthetic materials, including any of fabrics (e.g., polyethylene terephthalate fabrics) or natural tissues (e.g., pericardial tissue). Additional details about the use of skirts or sealing members in prosthetic valves can be found, for example, in U.S. Patent No. 11,399,932, which is incorporated herein by reference in its entirety.

[0083] Figure 2 A delivery device 100 is shown according to one example, which is suitable for delivering a prosthetic heart valve 102, such as the illustrated prosthetic heart valve 10 described above. The prosthetic valve 102 can be releasably coupled to the delivery device 100. It should be understood that the delivery device 100 and other delivery devices disclosed herein can be used to implant prosthetic devices other than prosthetic valves, such as stents or grafts.

[0084] The delivery device 100 in the illustrated example generally includes a handle 104, a first elongated shaft 106 (comprising an outer shaft in the illustrated example) 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 contract the prosthetic valve 102 when actuated.

[0085] Although the illustrated example 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 examples, there may be a greater or lesser number of actuator assemblies.

[0086] In some examples, the distal portion 116 of the shaft 106 can be sized to contain the prosthetic valve in its radially compressed delivery state during delivery of the prosthetic valve through the patient's vasculature. In this way, the distal portion 116 acts as a delivery sheath or capsule for the prosthetic valve during delivery.

[0087] The actuator assembly 108 can be releasably connected to the prosthetic valve 102. For example, in the example shown, each actuator assembly 108 can be connected to the corresponding 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 thrust and / or pulling force to each part of the prosthetic valve to radially expand and collapse the prosthetic valve as previously described. The actuator assembly 108 can be at least partially radially arranged in one or more lumens of the outer shaft 106 and axially extend through the lumens. For example, the actuator assembly 108 can extend through the central lumen of the shaft 106 or through a separate corresponding lumen formed in the shaft 106.

[0088] The handle 104 of the delivery device 100 can include one or more control mechanisms (e.g., knobs or other actuation mechanisms) for controlling the various components of the delivery device 100 in order to expand and / or deploy the prosthetic valve 102. For example, in the illustrated example, the handle 104 includes a first knob 110, a second knob 112, and a third knob 114.

[0089] The first knob 110 can be a rotatable knob configured to produce axial movement of the outer shaft 106 relative to the prosthetic valve 102 in a distal direction and / or a proximal direction so as to deploy the prosthetic valve from the delivery sheath 116 when the prosthetic valve has been advanced to a position at or adjacent to a desired implantation position in the patient. For example, rotating the first knob 110 in a first direction (e.g., clockwise) can retract the sheath 116 proximally relative to the prosthetic valve 102, and rotating the first knob 110 in a second direction (e.g., counterclockwise) can advance the sheath 116 distally. In some examples, the first knob 110 can be actuated by axially sliding or moving the knob 110, such as pulling and / or pushing the knob. In some examples, actuation of first knob 110 (rotational or sliding movement of knob 110 ) can produce axial movement of actuator assembly 108 (and thus prosthetic valve 102 ) relative to delivery sheath 116 to advance the prosthetic valve distally from sheath 116 .

[0090] The second knob 112 can be a rotatable knob configured to produce radial expansion and / or contraction of the prosthetic valve 102. For example, rotation of the second knob 112 can cause the actuator member and the support tube to move axially relative to each other. Rotation of the second knob 112 in a first direction (e.g., clockwise) can cause the prosthetic valve 102 to expand radially, and rotation of the second knob 112 in a second direction (e.g., counterclockwise) can cause the prosthetic valve 102 to collapse radially. In some instances, the second knob 112 can be actuated by axially sliding or moving the knob 112, such as pulling and / or pushing the knob.

[0091] The third knob 114 can be a rotatable knob configured to keep the prosthetic heart valve 102 in its expanded configuration. For example, the third knob 114 can be operably connected to the proximal portion of the locking tool of each actuator assembly 108. As described above, rotating the third knob in a first direction (e.g., clockwise) can rotate each locking tool to advance the locking nut to its distal position to resist radial compression of the frame of the prosthetic valve. Rotating the knob 114 in the opposite direction (e.g., counterclockwise) can rotate each locking tool in the opposite direction to decouple each locking tool from the prosthetic valve 102. In some instances, the third knob 114 can be actuated by axially sliding or moving the third knob 114, such as pulling and / or pushing the knob.

[0092] Although not shown, the handle 104 can include a fourth rotatable knob operatively connected to the proximal portion of each actuator member. The fourth knob can be configured to rotate each actuator member when the knob is rotated to unscrew each actuator member from the proximal portion of the corresponding actuator. As described above, once the locking tool and the actuator member are decoupled from the prosthetic valve 102, the locking tool and the actuator member can be removed from the patient.

[0093] Figure 3 An exemplary embodiment of a prosthetic heart valve 200 including an integral lattice frame 202 is shown. As previously described, the prosthetic valve 200 can include a valve structure including a plurality of leaflets (such as the valve structure 18 including the leaflets 20) and an inner skirt and / or an outer skirt, although these components are omitted for purposes of illustration. The frame 202 can include one or more axially extending struts or posts 204, one or more of which can be configured as an integral expansion and locking mechanism or actuator mechanism 206, the actuator mechanism including an actuator 234 (such as a threaded rod) and a first actuator strut / actuator post 222 and a second actuator strut / actuator post 224.

[0094] Figure 3 The frame 202 is illustrated in a partially expanded configuration and is shown coupled to an actuator assembly 300 of a delivery device (eg, delivery device 100).

[0095] The frame 202 can include an inflow end portion 208 (which is the distal end of the frame in the delivery configuration for the illustrated example) and an outflow end portion 210 (which is the proximal end of the frame in the delivery configuration for the illustrated example).

[0096] As described above, the frame 202 can include a plurality of axially extending struts or columns 204, one or more of which can be configured as an actuator mechanism 206. The actuator mechanism 206 can include a plurality of first actuator struts or actuator columns 222 (lower columns in the illustrated example, and can extend to the inflow end of the frame) and a plurality of second actuator struts or actuator columns 224 (upper columns in the illustrated example, and can extend to the outflow end of the frame). Each first actuator column 222 can be axially aligned with a corresponding second actuator column 224 to form a pair of first columns and second columns. One or more pairs of actuator columns 222, 224 can be configured as part of the actuator mechanism 206. The actuator columns 204 can be coupled together by a plurality of link members or struts 212. For example, in the illustrated example, the struts 212 define a plurality 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 examples, the cells may have any of a variety of other shapes, such as triangular, teardrop, rectangular, square, oval, square-oval, etc. For example, as described in more detail below, Fig.13 Another example of a prosthetic heart valve 400 is shown including a frame 402 having a plurality of axially extending struts or posts 404 coupled together by a plurality of curved link members or struts 412 .

[0097] Each hexagonal unit 214 is formed by two upper struts 252a, 252b, two lower struts 254a, 254b and two axial struts 256, 258, each axial strut extending between and connecting the respective ends of the upper struts 252a, 252b and the lower struts 254a, 254b. The upper struts 252a, 252b can be part of the upper row of struts that define the outflow end of the frame, and the lower struts 254a, 254b can be part of the lower row of struts that define the inflow end of the frame. Each rhombus unit 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 unit 214 can be connected to the second column 224, and the upper ends of the upper struts 260a, 260b of the corresponding diamond unit 216 can also be connected to the same second column 224. The lower ends of the lower struts 254a, 254b of each hexagonal unit 214 can be connected to the first column 222, and the lower ends of the lower struts 262a, 262b of the corresponding diamond unit 216 can also be connected to the same first column 222.

[0098] In the example shown, there is one row of hexagonal cells 214 and one row of diamond-shaped cells 216. In an alternative example, the frame 202 may include multiple rows of hexagonal cells 214 and multiple rows of diamond-shaped cells 216 arranged along the length of the frame, wherein the diamond-shaped cells 216 are positioned within the hexagonal cells.

[0099] The hexagonal cells 214 and the diamond cells 216 may each include a corresponding inflow vertex 218 and an outflow vertex 220. Each pair of actuator posts 222, 224 may extend through and be coupled to the inflow vertex 218 and the outflow vertex 220 of the corresponding pair of hexagonal cells 214 and diamond cells 216. In the illustrated example, the frame 202 includes six hexagonal cells 214 extending circumferentially in a row, each hexagonal cell 214 having a diamond cell 216 therein, and six pairs of actuator posts 222, 224 coupled to the corresponding pair of cells 214, 216. However, in some examples, the frame 202 may include a greater or lesser number of hexagonal cells 214 in a row, and a corresponding greater or lesser number of diamond cells 216 and / or pairs of actuator posts 222, 224.

[0100] In some examples, each pair of actuator posts 222, 224 can include a portion of the actuator mechanism 206 in combination with an actuator / threaded rod 234. For example, in the illustrated example, the frame includes six pairs of posts 222, 224, each pair of posts being configured as a portion of the actuator mechanism 206. In some examples, the frame 202 can include a greater or lesser number of actuator posts, and not all pairs of posts 222, 224 need to be actuator posts. Where a pair of posts 222, 224 are configured as a portion of the actuator mechanism, an actuator / screw / actuation bolt / threaded rod 234 extends through each actuator post 222, 224 in the pair to effectuate radial compression and expansion of the frame, as further described below. If the pair of posts 222, 224 are not configured as part of an actuator mechanism, the actuator / threaded rod 234 need not extend through the pair of posts 222 and 224, and the posts 222 and 224 need not include the other features described below for radially compressing and expanding the frame.

[0101] Although in the illustrated example, the actuator 234 is shown as a threaded rod, in some examples, the actuator can be any of a variety of members and / or mechanisms configured to axially move the first actuator post 222 and the second actuator post 224 relative to each other. For example, in some examples, the actuator 234 can be a linear rack including a plurality of teeth and configured to engage with corresponding pawls on the first and / or second actuator posts, or vice versa.

[0102] The upper end of each first actuator column 222 and the lower end of the corresponding second actuator column 224 can be separated by a gap G, thereby allowing the actuator columns 222, 224 to move toward and away from each other during radial expansion and radial compression of the frame. In the following description, the first actuator column 222 and the second actuator column 224, which are respectively part of the actuator mechanism (i.e., the actuator mechanism including the threaded rod 234), can also be referred to as the first actuator frame member 222 and the second actuator frame member 224, or more simply, the first frame member 222 and the second frame member 224.

[0103] Each actuator frame member 222, 224 may include an inner hole 232 ( Fig.11 ), the inner hole extends along the length of the frame members 222, 224, and the threaded rod 234 can extend through the inner hole. The outflow end portion 226 of the first frame member 222 can include or accommodate a nut 228. In some examples, the nut 228 can be formed separately from the frame member 222, and the frame member can be formed with a cutout area defining the window 230 in the outflow end portion of the frame member. The nut 228 can be positioned or accommodated in the cutout area. Figure 3 As shown, the nut 228 may be visible through the window 230. The nut 228 may include an internally threaded hole configured to engage the threads of the threaded rod 234 so that rotation of the threaded rod 234 causes the first frame member 222 coupled to the nut 228 to move relative to the second frame member 224, which remains stationary.

[0104] In some examples, instead of using a nut 228, a portion of the inner bore 232 of the first frame member 222 can be threaded. For example, the outflow end portion of the first frame member 222 can include internal threads that are configured to engage with the threaded rod 234, so that rotation of the threaded rod causes the first frame member 222 to move relative to the second frame member 224. In some examples, the inner bore 232 of the first frame member 222 can be threaded along its entire length. In alternative examples, each second frame member 224 can have internal threads or can accommodate a nut 228 that can engage with the external threads of the threaded rod 234.

[0105] Rotation of the threaded rod 234 in a first direction (e.g., clockwise) causes the first frame member 222 and the second frame member 224 to move toward corresponding axial directions of each other, thereby expanding the frame 202, and rotation of the threaded rod 234 in a second direction (e.g., counterclockwise) causes the first frame member 222 and the second frame member 224 to move away from corresponding axial directions of each other, thereby compressing the frame. When the frame 202 moves from the compressed configuration to the expanded configuration, the gap G between the first frame member 222 and the second frame member 224 of the actuator mechanism 206 can narrow. The threaded rod 234 can include a stopper 236 (e.g., in the form of a nut) disposed thereon. Figure 3 As shown, the stopper 236 can be disposed on the threaded rod 234 so 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) such that the stopper 236 moves toward the outflow end portion 210 of the frame 202 until the stopper abuts the inflow edge of the second frame member 224, thereby preventing the frame 202 from over-curling.

[0106] See also Figure 4 , the outflow end portion or proximal portion 238 of each threaded rod 234 may include a head portion 240 configured to be releasably coupled to a corresponding actuator assembly 300. The head portion 240 may include a first protrusion and a second protrusion 242 defining a channel or slot 244 therebetween, and one or more shoulders 246. Fig.11 As shown, the width of the head portion 240 can be greater than the diameter of the inner hole 232, so that the head portion 240 is prevented from moving into the inner hole 232 of the second frame member 224 and the head portion 240 abuts the outflow end portion 210 of the frame 402. For example, during radial expansion of the frame 402, the head portion 240 can be used to apply a distal force to the second frame member 224.

[0107] While the second frame member 224 is stably held in a fixed position relative to the distal device and surrounding anatomical structures (e.g., using the actuator assembly 300 of the delivery device) or a distal force is applied to the second frame member 224, the rotation of the threaded rod 234 causes the inflow end 208 and the outflow end 210 to move axially relative to each other, thereby causing radial expansion or compression of the frame 202. For example, moving the inflow end 208 and the outflow end 210 toward each other causes the frame to shorten axially and expand radially. In contrast, moving the inflow end 208 and the outflow end 210 away from each other causes the frame 202 to lengthen axially and compress radially.

[0108] like Figure 4-11As shown, the threaded rod 234 of each actuator mechanism 206 can be releasably coupled to a corresponding actuator assembly 300 of a delivery device (such as the delivery device 100 described previously). Figure 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. For illustration purposes, the outer sleeve 302 is Figure 4-6 9 and transparently shown. The distal end portion of the outer sleeve 302 and the driver 304 can 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 portion of the outer sleeve 302 and the driver 304 can be operably connected to the handle (e.g., handle 104) of the delivery device. The delivery device in this example can include the same features previously described for the delivery device 100. In some instances, the proximal portion of each driver 304 can be operably connected to the knob 112 so that the rotation of the knob 112 (clockwise or counterclockwise) causes the corresponding rotation of the driver 304. The proximal portion of each outer sleeve 302 can be operably connected to the knob 114 so that the rotation of the knob 114 (clockwise or counterclockwise) causes the sleeve 302 (towards the proximal side or to the distal side) relative to the corresponding axial movement of the driver 304. In some instances, the handle can include a motor for actuating these components.

[0109] The distal end portion of the driver 304 may include a central protrusion 306 configured to extend into the slot 244 of the threaded rod 234, and one or more flexible elongated elements 308 including protrusions or teeth 310 configured to releasably couple to the shoulder 246 of the threaded rod 234. The protrusions 310 may extend radially inwardly toward the longitudinal axis of the driver / second actuation member 304. Figure 4-5 As shown, the elongated element 308 can be configured to be biased radially outward into the expanded state, such as by shaping the element 308 .

[0110] like Figure 5 As shown, to couple the actuator assembly 300 to the threaded rod 234, the driver 304 can be positioned so that the central protrusion 306 is disposed within the slot 244 ( Figure 4 ) and position the protrusion 310 of the elongated element 308 distally of the shoulder 246. Figure 6 As the outer sleeve 302 is advanced (e.g., distally) over the driver 304, the elongated element 308 is radially compressed until the protrusion 310 abuts the shoulder 246, thereby coupling the actuator assembly 300 to the threaded rod 234. The outer sleeve 302 can continue to be advanced until the outer sleeve 302 is engaged with the frame 202, as shown in FIG. Figure 8So coupled, the driver 304 can be rotated (e.g., using a handle of the delivery device 100) to cause a corresponding rotation of the threaded rod 234. The central protrusion 306 can be configured (e.g., sized and shaped) such that it is advantageously spaced apart from the inner wall of the outer sleeve 302 so that the central protrusion 306 does not frictionally contact the outer sleeve 302 during rotation.

[0111] Although in the illustrated example, the cross-section of the central protrusion 306 is substantially rectangular, in some examples, the protrusion 306 may have any of a variety of shapes, such as square, triangular, oval, etc. The slot 244 may be correspondingly shaped to receive the protrusion 306 .

[0112] Reference now Figure 7 , the distal portion of the outer sleeve 302 may include a first support extension and a second support extension 312, defining a gap or recess 314 between the extensions 312. Figure 8 As shown, the support extension 312 can be oriented so that when the actuator assembly 300 is coupled to the corresponding actuator mechanism 206, the support extension 312 partially extends over the proximal portion (e.g., upper portion) of the second frame member 224, and specifically extends over the radially outer surface 248 and the radially inner surface 250 of the second frame member 224. The engagement of the support extension 312 with the frame 202 counteracts the rotational forces applied to the frame by the rod 234 during expansion of the frame. In the absence of a reaction force to resist these rotational forces, when the rod is actuated to expand the frame, the frame tends to "shake" or rock in the rotational direction of the rod. The illustrated configuration is advantageous because when engaged with the second frame member 224, the outer sleeve can prevent or mitigate such shaking or rocking motion of the frame when the frame is expanded.

[0113] The prosthetic valve 200 including one or more actuator mechanisms 206 can be expanded in the following exemplary manner. Generally, the prosthetic valve 200 is placed in a radially compressed state and releasably coupled to a delivery device (e.g., Figure 2The delivery device 100 shown in the figure can be provided with one or more actuator assemblies 300 of the delivery device 100 as described above, and the delivery device and the prosthetic valve can be advanced over the guidewire through the patient's vasculature to a selected implantation site (e.g., a native aortic valve annulus). For example, when the prosthetic valve is implanted within a native aortic valve, the delivery device and the prosthetic valve can be inserted into and through the femoral artery, and through the aorta to the native aortic valve. The prosthetic valve 200 can then be deployed at the implantation site (e.g., within the native aortic valve) and can be expanded and locked in an expanded configuration using the actuator mechanism 206. Once the selected diameter of the prosthetic valve 200 is reached, the actuator assembly 300 can be disconnected from the actuator mechanism 206 and removed from the patient.

[0114] To deploy the prosthetic valve 200, the physician may actuate the actuator assembly 300 by rotating the driver 304 in a first direction (e.g., by rotating the knob 112 or actuating the motor), which may cause a corresponding rotation of the threaded rod 234. The rotation of the threaded rod 234 may cause the first frame member 222 and the second frame member 224 of the actuator mechanism 206 to move axially toward each other to reduce the distance between the frame members 222, 224, thereby causing the frame 202 to shorten axially and expand radially until a selected diameter is reached. The disclosed actuator mechanism examples advantageously allow for continuous prosthetic valve expansion (e.g., without stepped expansion caused by a ratchet mechanism), and allow the prosthetic heart valve to be deployed at any of a variety of diameters.

[0115] Once prosthetic valve 200 has been implanted at a selected implantation site in a patient, the patient's native anatomy (e.g., native aortic annulus) may exert radial forces on prosthetic valve 200 that would tend to compress frame 202. However, the engagement of threaded rod 234 with nut 228 prevents such forces from compressing frame 202, thereby ensuring that the frame remains locked in the desired radially expanded state.

[0116] If it is desired to reposition or recapture and remove the prosthetic valve 200, the prosthetic valve can be compressed (from an expanded or partially expanded configuration) by rotating the driver 304 in a second opposite direction and thereby rotating the threaded rod 234. The rotation of the threaded rod 234 can cause the first frame member 222 and the second frame member 224 of the actuator mechanism 206 to move axially away from each other to increase the distance between the frame members 222, 224, thereby axially extending and radially compressing the frame 202. Once the prosthetic valve 200 has been recompressed, the prosthetic valve can be repositioned at the implantation site, and once repositioned, the prosthetic valve 200 can be expanded as previously described. The prosthetic valve can be recompressed, repositioned and re-expanded multiple times as needed. In some cases, the prosthetic valve 200 can be fully compressed and "recaptured", i.e., retracted into the sheath and / or removed from the patient.

[0117] Once the final positioning and expansion of the prosthetic valve is achieved, the actuator assembly 300 can be released from the prosthetic valve 200 by retracting the sleeves 302 to expose the connection between the driver 304 and the rod 234. This can be achieved by rotating the knob 114 or actuating the motor in the handle of the delivery device. As each sleeve 302 is retracted, the expandable element 308 of the driver 304 can expand outward and away from the shoulder 246 of the head portion 240 of the rod 234, thereby decoupling the driver 304 from the rod 234. At this stage, the delivery device (including all actuator assemblies 300) can be retracted relative to the prosthetic valve 200 and removed from the patient.

[0118] Fig.12 An example of a prosthetic valve 400 is shown having a frame 402 including 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 from the inflow end 408 through the prosthetic valve 400 to the outflow end 410.

[0119] Prosthetic valve 400 may be similar to prosthetic valve 200 described above, including a frame 402 including a plurality 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 by a plurality of linkage members or struts 412. Prosthetic valve 400 in this example may include the same features previously described with respect to prosthetic valve 200, and may be coupled to actuator assembly 300 and expanded as described above with respect to prosthetic valve 200.

[0120] The valve structure 454 can include, for example, a leaflet assembly including one or more leaflets 456 made of a flexible material. The leaflets 456 can be made of a biomaterial, a biocompatible synthetic material, or other such material in whole or in part. Suitable biomaterials can include, for example, bovine pericardium (or pericardium from other sources). The leaflets 456 can be fixed to each other at their adjacent sides to form commissures 458, each of which can be fixed to a corresponding column 404 (e.g., fixed to a support column 407) or fixed to the frame 402.

[0121] In the depicted example, the valve structure 454 includes three leaflets 456 that can be arranged to collapse in a tricuspid arrangement. Each leaflet 456 can have an inflow edge portion 460. Fig.12 As shown, the inflow edge portion 460 of the leaflet 456 can define an undulating curved scalloped edge that follows or tracks in the circumferential direction a portion of the struts 412 of the frame 402 when the frame 402 is in the radially expanded configuration. The inflow edge 460 of the leaflet can be referred to as a "scalloped line."

[0122] like Fig.12 As shown, the inflow edge portion 460 of the leaflet 456 can be sutured generally along the scalloped line to the inner skirt 464. The inner skirt 464 can in turn be sutured to the adjacent struts 412 of the frame 402, for example, by one or more sutures 462. In other examples, the leaflet 456 can be sutured directly to the frame 402 along the scalloped line.

[0123] The prosthetic valve 400 may further include one or more skirts or sealing members. For example, as mentioned above, the prosthetic valve 400 may include an inner skirt 464 mounted on the radially inner surface of the frame 402. The inner skirt 464 may be used as a sealing member to prevent or reduce paravalvular leakage, to anchor the leaflets to the frame, and / or to protect the leaflets from damage caused by contact with the frame during curling and during the working cycle of the prosthetic valve. The prosthetic valve 400 may further include an outer skirt 466 mounted on the outer surface of the frame 402. The outer skirt 466 may be used as a sealing member of the prosthetic valve by sealing the tissue of the natural valve ring and helping to reduce paravalvular leakage through the prosthetic valve. The inner and outer skirts 464, 466 may be formed of any of a variety of suitable biocompatible materials, including various synthetic materials, including any of fabrics (e.g., polyethylene terephthalate fabrics) or natural tissues (e.g., pericardial tissue). Additional details regarding the use of skirts or sealing members in prosthetic valves can be found, for example, in US Patent Application No. 62 / 854,702.

[0124] Prosthetic valve 400 is radially expandable and compressible between a radially expanded configuration and a radially compressed configuration. Fig.13 A bare frame 402 (without leaflets or other components) of the prosthetic valve 400 is shown for purposes of illustrating the configuration of the frame 402. Fig.13 Only one side of the frame 402 is depicted in FIG. 4 , but it should be understood that the frame 402 forms an annular structure having opposing sides that are substantially the same as the portion shown.

[0125] like Fig.13 As shown, the struts 412 of the frame 402 may include 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, the axially extending elliptical shape including a first vertex and a second vertex 416 (e.g., an inflow vertex 416a and an outflow vertex 416b) disposed at the primary highest point of the ellipse. Each first cell 414 may further include a corresponding second cell 418 disposed within the outer perimeter of the first cell 414. The second cell 418 may have a circumferentially extending elliptical shape, the circumferentially extending elliptical shape including a first vertex and a second vertex 420 (e.g., an inflow vertex 420a and an outflow vertex 420b) disposed at the secondary highest point of the ellipse.

[0126] In some instances, such as Fig.13 In the example shown, each pillar 412 can have an inverted bend or S-shape, which includes a first upward curved portion 413 and a second downward 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, while 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 pillar 412 can be abutted against a column 404 (e.g., support column 407 and / or actuator mechanism 406) in an asymptotic manner and terminate at either end, so that it is almost parallel to the longitudinal axis extending through the inflow end and the outflow end of the frame 402. The pillar 412 can be arranged so that the upward curved portion 413 is placed closer to the inflow end 408 of the frame 402, and the downward curved portion 415 is placed closer to the outflow end 410.

[0127] As mentioned, the frame 402 can include a plurality of axially extending struts or columns 404, which include a plurality of first actuator struts or actuator columns 422 (lower columns in the illustrated example, and can extend to the inflow end of the frame) and a plurality of second actuator struts or actuator columns 424 (upper columns in the illustrated example, and can extend to the outflow end of the frame). Each first actuator column 422 can be axially aligned with a corresponding second actuator column 424 of a pair of first and second actuator columns. One or more pairs of actuator columns 422, 424 in combination with an actuator 426 (such as a threaded rod) can be configured as an actuator mechanism 406. The frame 402 can further include additional columns 404, which are configured as support columns 407. A support column 407 may be disposed between each adjacent pair of circumferentially disposed first cells 414, and an actuator mechanism 406 may be disposed such that it extends through and couples to vertices 416, 420 of the first and second cells. The columns 404 may be coupled together by struts 412.

[0128] Each first unit 414 is formed by two upper struts 468a, 468b and two lower struts 470a, 470b. Each upper strut 468 and lower strut 470 is connected to the actuator mechanism 406 at one end and is connected to the support column 407 at the other end. The upper struts 468a, 468b can be part of the upper row of struts that define the outflow end of the frame, and the lower struts 470a, 470b can be part of the lower row of struts that define the inflow end of the frame. Each second unit 418 is formed by two upper struts 472a, 472b and two lower struts 474a, 474b. The lower ends of the upper struts 472a, 472b and the upper ends of the lower struts 474a, 474b can be connected to the support column 407. The upper ends of the upper struts 472a, 472b and the lower ends of the lower struts 474a, 474b can be connected to the corresponding actuator mechanism 406. In the illustrated example, the upper ends of the upper struts 472a, 472b may be connected to the second column 424 and the lower ends of the lower struts 474a, 474b may be connected to the first column 422.

[0129] As mentioned, the first unit 414 and the second unit 418 can each include an inflow vertex 416a, 420a and an outflow vertex 416b, 420b. Each pair of posts 422, 424 can extend through and be coupled to the inflow vertex 416 and the outflow vertex 420 of the corresponding first unit pair and the second unit pair. In the illustrated example, the frame 402 includes six first units 414 extending circumferentially in a row, each of the first units 414 having a second unit 418 therein, and six pairs of posts 422, 424 coupled to the corresponding pair of units 414, 418. However, in some examples, the frame 402 can include a greater or lesser number of first units 414 and a corresponding greater or lesser number of second units 418 and / or pairs of posts 422, 424 in a row.

[0130] In some examples, each pair of actuator posts 422, 424 can be configured as part of an actuator mechanism 406 in combination with an actuator 426 (e.g., a threaded rod). For example, in the illustrated example, each of the six pairs of actuator posts 422, 424 is configured as part of an actuator mechanism 406 in combination with an actuator 426. In some examples, not all pairs of actuator posts 422, 424 need to be part of an actuator mechanism. In the case where a pair of actuator posts 422, 424 are configured as part of an actuator mechanism, a screw / actuator bolt / threaded rod 426 (including a head portion 425) extends through each of the pair of actuator posts 422, 424 to achieve radial compression and expansion of the frame, similar to the previously described actuator mechanism 206. If a pair of actuator posts 422, 424 is not used as an actuator mechanism, the actuator 426 does not need to extend through the pair of actuator posts 422, 424. In the following description, the first actuator column 422 and the second actuator column 424 respectively used as an actuator mechanism (i.e., an actuator mechanism including the actuator 426) may be referred to as the first actuator frame member 422 and the second actuator frame member 424, or more simply, the first frame member 422 and the second frame member 424.

[0131] Although in the illustrated example, the actuator 426 is shown as a threaded rod, in some examples, the actuator 426 can be configured to axially move the first actuator post 422 and the second actuator post 424 relative to each other to expand and / or compress any of the various components and / or mechanisms of the frame 402. For example, in some examples, the actuator 426 can be a linear rack including a plurality of teeth and can be configured to engage with corresponding pawls on the first and / or second actuator posts, or vice versa.

[0132] In the illustrated example, the actuator mechanism 406 can function in the same manner as the actuator mechanism 206 and can include a threaded nut 423 disposed at an outflow end portion of the first frame member 422 configured to engage the threaded rod 426. The nut 423 can be received in a passageway of the second frame member 422 (e.g., disposed within a window 427). Figure 12-13 As shown, the nut 423 may be sized to fill the window 427 such that movement of the nut 423 relative to the second frame member 422 is limited.

[0133] Rotation of the threaded rod 426 in a first direction (e.g., clockwise) can cause the first frame member 422 and the second frame member 424 to move toward each other (as indicated by arrows 428), thereby expanding the frame 402; and rotation of the threaded rod 426 in a second direction (e.g., counterclockwise) causes the first frame member 422 and the second frame member 424 to move away from each other (as indicated by arrows 430), thereby compressing the frame. As the frame 402 moves from the compressed configuration to the expanded configuration, the gap G ( Fig.13 ) can be narrowed.

[0134] 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) such that the stopper 432 moves toward the outflow end portion 434 of the frame 402 until the stopper abuts the inflow edge of the second frame member 424.

[0135] Because the threaded rod 426 is fixed to the frame 402 at axially spaced locations (the inflow end 408 and the outflow end 410), rotating the threaded rod 426 causes the inflow end 436 and the outflow end 434 to move axially relative to each other to cause radial expansion or compression of the frame 402. For example, moving the inflow end and the outflow end 436, 434 toward each other causes the frame 402 to shorten axially and expand radially. In contrast, moving the inflow end and the outflow end 436, 434 away from each other causes the frame 402 to lengthen axially and compress radially.

[0136] like Fig.13As shown, the support column 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 support columns 407 can include a commissure support member 442. The commissure support member 442 can include a first commissure arm and a second commissure arm 444 defining a commissure opening 446 therebetween. The commissure opening 446 can extend radially through the thickness of the column 404 and can be configured to receive a portion of the valve structure 454 (e.g., the commissure 458) to couple the valve 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 column 404. However, in other examples, the commissure opening can have any of a variety of shapes (e.g., square, oval, square-oval, triangle, L-shaped, T-shaped, C-shaped, etc.). In some examples, the opening 446 can be completely closed by the 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 extending into the commissure opening 446. The teeth 448 can help to retain the commissure 458 within the commissure opening. Each commissure 458 can be mounted to a corresponding commissure support member 442, such as by inserting a pair of adjacent leaflets through the opening 446 and suturing the commissure tabs to each other and / or the arms 444.

[0137] The inflow end portion 438 of each support column 407 may include a cantilevered extension 450 extending toward the inflow end portion 436 of the frame 402. The extension 450 may include an orifice 452 extending radially through the thickness of the extension. In some examples, the extension 450 may extend so that the inflow edge of the extension is aligned or substantially aligned with the inflow edge of the frame 402. In use, the extension 450 can prevent or mitigate the radial inward extension of a portion of the outer skirt 466, and thereby prevent or mitigate any flow obstruction through the inflow end 436 caused by the outer skirt 466. The extension 450 can further act as a support to which portions of the inner skirt 464 and / or the outer skirt 466 can be coupled. For example, sutures for connecting the inner skirt and / or the outer skirt can be wrapped around the extension 450 and / or can extend through the opening 452. In some examples, the tip edge portion 460 of the leaflet 456 can be supported by the extension 450 or a selected extension in the extension. For example, the cusp edge portion 460 can be secured to the adjacent extension 450 with sutures, which can extend through the opening 452.

[0138] As mentioned, Fig.13 Only one side of the frame 402 is depicted. Although only one support column 407 including the commissure support member 442 is shown Fig.134, but it should be noted that the frame 402 can include any number of support columns 407, any number of which can be configured as commissure support members 442. For example, the frame 402 can include six support columns 407, three of which are configured as commissure support members 442. In some examples, for example, the frame can include one, two, three, or four commissure support members.

[0139] The actuator mechanism 406 may be releasably coupled to one or more actuator assemblies 300, as previously described 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 previously described with respect to the prosthetic heart valve 200. The actuator assembly 300 may actuate the actuator mechanism 406 to cause the frame 402 to expand and / or compress.

[0140] Once prosthetic valve 400 has been implanted at a selected implantation site in a patient, the patient's native anatomy (e.g., native aortic annulus) may exert radial forces on prosthetic valve 400 that would tend to compress frame 402. However, the engagement of threaded rod 426 with threaded nut 423 of first frame member 422 prevents such forces from compressing frame 402, thereby ensuring that the frame remains locked in the desired radially expanded state.

[0141] If it is desired to reposition or recapture and remove the prosthetic valve 400, the prosthetic valve can 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). The rotation of the threaded rod 426 can cause the first and second frame members 422, 424 of the column to move axially away from each other to increase the distance between the frame members 422, 424, thereby extending the frame axially and compressing radially. Once the prosthetic valve 400 has been recompressed, the prosthetic valve can be repositioned at the implantation site, and once repositioned, the prosthetic valve 400 can be expanded as previously described. The prosthetic valve can be recompressed, repositioned, and re-expanded multiple times as needed. In some cases, the prosthetic valve 400 can be fully compressed and "recaptured", i.e., retracted into the sheath and / or removed from the patient.

[0142] In some examples, selected threaded rods 426 may be configured as "right-hand" rods, and selected threaded rods 426 may be configured as "left-hand" rods. As used herein, the term "right-hand" rod means a rod in which rotation of the rod in a first direction (e.g., clockwise) effects expansion of the frame 402, and the term "left-hand" rod means a rod in which rotation of the rod in a second direction (e.g., counterclockwise) effects expansion of the frame 402. Fig.14, the prosthetic valve 400 can include six actuator mechanisms 406, each actuator mechanism including a threaded rod 426 (eg, threaded rods 426a, 426b, 426c, 426d, 426e, and 426f).

[0143] In some examples, right-hand 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 in a first direction (e.g., clockwise) (e.g., using a mechanism in the handle of the delivery device), and the left-hand rods 426b, 426d, and 426f can be rotated in a second direction (e.g., counterclockwise) opposite to the first direction. 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 oppositely directed rotational forces to alternating rods 426 can help prevent or mitigate shaking or rocking motion of the frame as it expands or compresses.

[0144] In some examples, the right-hand lever can be disposed along a first semicircular portion of the circumference of the frame 402, and the left-hand lever can be disposed along a second semicircular portion of the circumference, such that the levers 426a, 426b, and 426c are configured as right-hand levers, and the levers 426d, 426e, and 426f are configured as left-hand levers. During expansion of the frame 402, the right-hand levers 426a, 426b, 426c can rotate in a first direction (e.g., clockwise), and the left-hand levers 426d, 426e, 426f can rotate in a second, opposite direction (e.g., counterclockwise). During compression of the frame 402, the right-hand lever can rotate in a second direction (e.g., counterclockwise), and the left-hand lever can rotate in a first direction (e.g., clockwise).

[0145] Figure 15-28 An actuator assembly 500 of a delivery device that can be used to expand and / or compress a prosthetic valve (e.g., any of the prosthetic valves disclosed herein) is shown (see, e.g., Fig. 22 ). Actuator assembly 500 can be a component of a delivery device (such as delivery device 100 described previously) and can be configured to releasably couple and actuate a corresponding actuator / screw / actuation bolt / threaded rod of a prosthetic valve, such as threaded rod 504 of actuator mechanism 506, partially shown in Figure 22-25Although not fully shown, actuator mechanism 506 can have first and second actuator post / frame members separated by a gap through which threaded rod 504 extends (similar to first and second frame members 422 and 424 of prosthetic valve 400). Threaded rod 504 can be used in place of or in addition to threaded rods 234 and / or 426 of prosthetic valves 200 and 400. The delivery device can include multiple actuator assemblies 500, one for each threaded rod 504 of the prosthetic valve.

[0146] refer to Figure 15-17 , the threaded rod 504 can include an elongated body 508 having a threaded portion 510, a non-threaded portion 511, and a head portion 512, the head portion being configured to be releasably coupled to the corresponding actuator assembly 500. In some examples, such as the illustrated example, the threaded rod 504 can include an annular recess 514 formed in the non-threaded portion 511. In some examples, the recess 514 can accommodate a stopper, such as the previously described stopper 432, which can be swaged to the rod 504. In some examples, the threaded rod 504 can be formed without the recess 514. In such examples, the stopper can be welded to the rod 504 at a selected location.

[0147] like Fig. 27 As shown, the diameter D1 of the head portion 512 can be larger than the diameter D2 of the inner hole 516 of the frame 502 of the prosthetic valve, so that the head portion 512 is prevented from moving into the inner hole 516 of the frame 502 and the head portion 512 abuts against the outflow edge 518 of the frame 502, for example, as shown in FIG. Fig.28 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 that of the frame 402.

[0148] The head portion 512 may include a central recess 520 and one or more protrusions 522 disposed around the outer periphery of the head portion 512. In the illustrated example, as shown in FIG. Fig.17 As shown, the cross-section of the protrusion 522 can be substantially semicircular. In some examples, the cross-section of the protrusion 522 can have any of a variety of other shapes, such as square, rectangular, triangular, etc. Although the illustrated example shows four protrusions 522, in some examples, the head portion 512 can have any number of protrusions, such as one, two, three, four, five, six, seven, eight, etc. In the illustrated example, the central recess 520 is configured as a square recess with rounded corners, however, in some examples, the central recess 520 can have any of a variety of other shapes, such as rectangular, oval, triangular, etc.

[0149] While the outflow end of the frame 502 is stably held in a fixed position relative to the distal portion of the delivery device and the surrounding anatomical structures (e.g., using the actuator assembly 500 of the delivery device) or a force directed toward the distal side is applied to the frame 502, the rotation of the threaded rod 504 causes the inflow end and the outflow end of the frame 502 to move axially relative to each other to cause radial expansion or compression of the frame. For example, moving the inflow end and the outflow end toward each other causes the frame 502 to shorten axially and expand radially. In contrast, moving the inflow end and the outflow end away from each other causes the frame 502 to lengthen axially and compress radially.

[0150] refer to Figure 18-21 Each actuation assembly 500 may include a first actuation member ( Fig.18 ) and a second actuating member ( Fig.19 ).like Fig.26 As best seen, the driver 526 can extend through the outer sleeve / support tube 524. The outer sleeve 524 and the distal end portion of the driver 526 can be configured to mate with the outflow end portion 528 ( Fig.15 ) and / or the outflow end portion 530 of the frame 502. The outer sleeve 524 and the proximal portion of the driver 526 can be operatively coupled to a handle of a delivery device (e.g., the handle 104 of the delivery device 100). The delivery device in this example can include the same features previously described for the delivery device 100. In some examples, the proximal portion of each driver 526 can be operatively coupled to the knob 112 so that rotation of the knob 112 (clockwise or counterclockwise) causes a corresponding rotation of the driver 526. The proximal portion of each outer sleeve 524 can be operatively coupled to the knob 114 so that rotation of the knob 114 (clockwise or counterclockwise) causes a corresponding axial movement of the sleeve 524 (proximally or distally) relative to the driver 526. In some examples, the handle can include a motor for actuating these components.

[0151] refer to Fig.18 , the first or distal portion 532 of the outer sleeve 524 may include a first support extension and a second support extension 534 defining a gap or recess 535 therebetween. Fig. 22As shown, the support extension 534 can be oriented so that when the actuator assembly 500 is coupled to the corresponding actuator 506 of the frame 502, the support extension 534 partially extends over the outflow end portion (e.g., upper end portion) of the frame 502, such as the outflow vertex or pillar portion, and specifically extends over the radial outer surface 536 and radial inner surface 538 of the outflow vertex and the vertical pillar extending from the vertex. The engagement of the support extension 534 with the frame 502 offsets the rotational forces applied to the frame by the rod 504 during the expansion of the frame 502. In the absence of a reaction force to resist these rotational forces, when the rod is actuated to expand the frame, the frame tends to "shake" or rock in the rotational direction of the rod. The configuration shown is advantageous because when engaged with the actuator mechanism 506, the outer sleeve 524 can prevent or mitigate such shaking or rocking motion of the frame when the frame is expanded.

[0152] In some instances, such as Fig.18 As shown, the distal portion 532 of the outer sleeve 524 may include a material and / or construction that is different from the material and / or construction of the elongated body 537. For example, in some examples, the distal portion 532 may be a formed laser cut tube that includes a nickel-cobalt based alloy such as MP35N. And the elongated body 537 can be stainless steel. In some examples, the elongated body 537 can be a hollow torque cable. In some examples, the elongated body 537 can be a laser cut slotted hypotube.

[0153] refer to Fig.19 , the driver 526 may include an elongated body 540 and a coupling portion 542 disposed at a distal portion of the elongated body 540. In some examples, the elongated body 540 may include a cable, such as a 0.85 mm cable. In some examples, the elongated body 540 may be, for example, a slotted hypotube. The coupling portion 542 may include a driver head 544 and a clamp member 546. As shown in the illustrated example, the driver head 544 may be coupled to the elongated body using, for example, a fastener 548. In some examples, the driver head 544 may be welded or otherwise permanently coupled to the elongated body 540. In some examples, the driver head 544 and the elongated body 540 may be integrally formed with each other.

[0154] In some examples, the gripper member 546 can be coupled to the elongated body 540 by sandwiching the annular base 560 of the gripper member 546 between the second end portion 554 of the driver head 544 and the fastener 548. The fastener 548 can then be welded to the driver head 544, capturing the annular base 560 therebetween so as to limit axial movement of the gripper member relative to the driver head 544. In some examples, the gripper member 546 can be integrally formed with the fastener 548, or can be coupled to the fastener 548 in other ways, such as by welding. In some examples, the elongated body 540, the driver head 544, and the gripper member 546 can be welded together, while in some examples, they can be coupled together using a swaged connection.

[0155] refer to Fig. 20 , the driver head 544 may include a body 550 having a first end portion 552 and a second end portion 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 each other around the periphery of the driver head 544. The engagement member 556 may extend distally from the first end portion 552 of the body 550 and may be configured to engage with the recess 520 of the corresponding threaded rod 504. Although in the illustrated example, the cross-section of the engagement member 556 is a square with chamfered edges, in some examples, the engagement member 556 may have any of a variety of shapes, such as rectangular, triangular, oval, etc. The recess 520 in 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 the torque transmission from the driver 526 to the threaded rod 504.

[0156] like Fig.26 As best seen, the first end portion 552 of the driver head 544 can have a first diameter D3, and the second end portion 554 can have a second, smaller diameter D4. The second end portion 554 can extend into the fastener 548 to couple the driver head 544 to the elongated body 540. In some examples, the driver head 544 can include a nickel-cobalt based alloy, such as MP35N.

[0157] Reference now Fig.21 , the clamp member 546 may include an annular base member 560 and one or more extension members / wings / arms 562. The arms 562 may extend distally from the base member 560 and may be resilient so that they may be positioned in an extended position ( Fig.19 ) and compression positioning ( Fig.23) between the arms 562. The arms 562 can be configured to be biased radially outward (e.g., away from the longitudinal axis of the driver 526) into an expanded shape, for example, by shaping the arms 562. Each arm 562 can include a first elongated opening 564 and a second opening 566. In the illustrated example, the gripper member 546 includes four arms, however, in some examples, the gripper member 546 can include any number of arms, such as one, two, three, four, five, six, seven, eight, etc. In some examples, the gripper member 546 can include a laser cut Nitinol tube that can be heat set so that the arms 562 are biased radially outward.

[0158] like Fig.19 As shown, the protrusion 558 of the driver head 544 can extend into the first opening 564 to limit the axial and rotational movement of the clamp member 546 relative to the driver head 544. The second opening 566 can be configured (e.g., sized and shaped) to engage with the protrusion 522 disposed on the head portion 512 of the corresponding threaded rod 504, thereby releasably coupling the actuation assembly 500 to the threaded rod 504. In the illustrated example, the first opening 564 is an elongated rectangular opening and the second opening 566 is a substantially square opening, however, in some examples, 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.

[0159] The actuator assembly 500 can be coupled to the corresponding actuator mechanism 506 of the prosthetic valve as follows. The engagement member 556 of the driver 526 can be disposed within the recess 520 of the head portion 512 of the threaded rod 504 such that the second opening 566 of the gripper member arm 562 is disposed adjacent to the protrusion 522. As the outer sleeve 524 is advanced (e.g., distally) over the driver 526, the arm 562 is radially compressed until the protrusion 522 is located within the second opening 566, thereby coupling the actuator assembly 500 to the threaded rod 504 (e.g., as shown in FIG. 1 ). Fig.26 ). The outer sleeve 524 may continue to advance until the support extension 534 engages with the radial inner surface 536 and the radial outer surface 538 of the frame 502, as shown. Fig. 22 So coupled, the driver 526 can be rotated (e.g., using 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 the torque transfer between the driver and the threaded rod 504.

[0160] Typically, the prosthetic valve is placed in a radially compressed state and the actuator mechanism 506 of the prosthetic valve is releasably coupled to one or more actuator assemblies 500 in the manner previously described, such as Fig. 22 and 26 As shown. The delivery device and prosthetic valve can be advanced over the guide wire through the patient's vasculature to a selected implantation site (e.g., a native aortic annulus). For example, when the prosthetic valve is implanted within a native aortic valve, the delivery device and prosthetic valve can be inserted into and through the femoral artery, and through the aorta to the native aortic valve. The prosthetic valve can then be deployed at the implantation site (e.g., within the native aortic valve) and can be expanded and locked in an expanded configuration using an actuator mechanism 506.

[0161] To deploy the prosthetic valve, the physician may actuate the actuator mechanism 506 by rotating the driver 526 in a first direction (e.g., by rotating the knob 112 or actuating the motor), which causes a corresponding rotation of the threaded rod 504. The rotation of the threaded rod 504 in the first direction causes the first and second frame members of the actuator mechanism (e.g., similar to the first and second frame members 422, 424 of the prosthetic valve 400) to move axially toward each other, thereby causing the frame 502 to shorten axially and expand radially until a selected diameter is reached. The disclosed actuator mechanism examples advantageously allow for continuous prosthetic valve expansion (e.g., without stepped expansion caused by a ratchet mechanism), and allow the prosthetic heart valve to be deployed at any of a variety of diameters.

[0162] refer to Figure 22-28 Once final positioning and expansion of the prosthetic valve is achieved, the actuator assembly 500 can be released from the prosthetic valve in the following exemplary manner. The outer sleeve 524 can be retracted to expose the connection between the driver 526 and the threaded rod 504, such as Fig.23 and 27 This can be accomplished by rotating the knob 114 or actuating a motor in the handle of the delivery device 100. Fig.24 and 27 As shown, once the outer sleeve 524 is retracted, the arms 562 of the clamp member 546 can be expanded radially outward away from the head portion 512 of the threaded rod 504. Fig.25 and 28 As shown, the driver 526 can then be retracted, thereby removing the engagement member 556 from the recess 520 of the stem 504, thereby decoupling the driver 526 from the stem 504. At this stage, the delivery device (including the actuator assembly 500) can be retracted relative to the prosthetic valve and removed from the patient.

[0163] Figure 29-35Another example of an actuator assembly 600 of a delivery device that may be used to radially expand and / or compress a prosthetic valve is shown. Fig.29 The actuator assembly 600 is shown in use on an exemplary frame 700 of a prosthetic valve, however, the actuator assembly 600 may be used on any of the prosthetic valves described herein and / or other prosthetic valves having a similar expansion mechanism. Fig.29 700, it should be understood that frame 700 forms an annular structure having an opposite side substantially identical to the one side shown. Further, although not shown, frame 700 can support a valve structure and can include an inner skirt and / or an outer skirt to form a prosthetic heart valve similar to prosthetic heart valve 400.

[0164] The actuator assembly 600 can be a component of a delivery device (such as the delivery device 100 previously described) and can be configured to releasably couple and actuate a corresponding actuator / screw / actuation bolt / threaded rod of a prosthetic valve, such as the threaded rod 702 of the actuator mechanism 704, partially shown in FIG. Figure 29-35 Reference Fig.29 , the actuator mechanism 704 can have a first actuator column / frame member 706 and a second actuator column / frame member 708 (similar to the first frame member 422 and the second frame member 424 of the prosthetic valve 400) separated by a gap through which the threaded rod 702 extends. The threaded rod 702 can be used instead of or in addition to the threaded rods 234 and / or 426 of the prosthetic valves 200 and 400. The delivery device can include a plurality of actuator assemblies 600, one actuator assembly for each threaded rod 702 of the prosthetic valve. The delivery device can include any number of actuator assemblies (e.g., 1-15 actuator assemblies). The number of actuator assemblies of the delivery device can be determined, for example, by the number of threaded rods of the prosthetic valve that the delivery device is being used to implant. For example, a delivery device including three actuator assemblies can be used with a prosthetic valve including three threaded rods. As another example, a delivery device including six actuator assemblies can be used with a prosthetic valve including six threaded rods. Although for illustrative purposes Fig.29 Only one threaded rod 702 is shown in FIG. 7 , but it should be understood that each pair of first and second actuator column / frame members may include a threaded rod 702 .

[0165] The threaded rod 702 may include an elongated body 710 (partially shown in Fig.33 ) and a head portion 712 configured to be releasably coupled to a corresponding actuator assembly 600. Fig.34As shown, the diameter D1 of the head portion 712 can be greater than the diameter D2 of the inner hole 714 of the second column 708, so that the head portion 712 is prevented from moving into the inner hole 714 of the frame 700 and the head portion 712 abuts the outflow edge 716 of the frame 700, for example, as shown in FIG. Fig.34 Head portion 712 of threaded rod 702 can be used to apply a distally directed force to frame 700 , for example, during radial expansion of frame 700 . Frame 700 can be similar to frame 402 of prosthetic heart valve 400 .

[0166] refer to Fig.32 , the head portion 712 can include a central recess 718 and a circumferential recess 720 extending around the head portion 712. In the illustrated example, the central recess 718 is configured as a square recess, however, in some examples, the central recess can have rounded corners (e.g., similar to the recess 520), or can have any of a variety of other non-circular shapes, such as rectangular, oval, triangular, star-shaped, etc. In some examples, the central recess 718 can have one or more facets that engage with corresponding facets of the engagement member 624 of the driver head, so that when the engagement member 624 is disposed in the central recess 718, the rotational movement of the driver 604 causes the threaded rod 702 to rotate. In some examples, the central recess 718 can be threaded, and the engagement member 624 can correspondingly have a threaded shape so that the two components can be coupled together. In such examples, the cross-section of the central recess 718 and / or the engagement member 624 can be circular. The angled / chamfered proximal surface 724 ( Fig.33 ) is substantially tubular in shape, which can, for example, facilitate engagement with a delivery device as described below.

[0167] Rotation of the threaded rod 702 relative to the frame 700 (e.g., using the actuator assembly 600 of the delivery device) causes relative axial movement between the inflow end and the outflow end of the frame 700, which in turn causes radial expansion or compression of the frame. For example, moving the inflow end and the outflow end toward each other (by rotation of the rod 702) causes the frame 700 to shorten axially and expand radially. In contrast, moving the inflow end and the outflow end away from each other (by rotation of the rod 702) causes the frame 700 to lengthen axially and compress radially.

[0168] refer to Figure 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. The distal end portions of the outer sleeve 602 and the driver 604 can be configured to engage or abut with the head portion 712 of the threaded rod 702 and / or the outflow end portion 722 of the frame 700.

[0169] The outer sleeve 602 and the proximal portion of the driver 604 can be operatively coupled to a handle of a delivery device (e.g., the handle 104 of the delivery device 100). The delivery device in this example can include the same or similar features previously described for the delivery device 100. In some examples, the proximal portion of each driver 604 can be operatively coupled to the knob 112, such that rotation of the knob 112 (clockwise or counterclockwise) causes a corresponding rotation of the driver 604. The proximal portion of each outer sleeve 602 can be operatively coupled to the knob 114, such that rotation of the knob 114 (clockwise or counterclockwise) causes a corresponding axial movement of the sleeve 602 (proximally or distally) relative to the driver 604. In some examples, the handle can include a motor, button, switch, circuitry, etc. for actuating these components.

[0170] refer to Fig.31 , the outer sleeve 602 may include a first or distal portion 606 and an elongated body 612. The distal portion 606 of the outer sleeve 602 may include a first support extension and a second support extension 608, the support extensions defining a gap or recess 610 ( Fig.30 ). The support extension 608 and the recess 610 can function in the same or similar manner as described previously for the support extension 534 and the recess 535. In some examples, the distal portion 606 of the outer sleeve 602 can include a material and / or construction different from that of the elongated body 612.

[0171] refer to Fig.33 , the driver 604 may include an elongated body 614 and an engagement portion 616 disposed at a distal portion of the elongated body 614. The engagement portion 616 may include a driver head 618 and a clamp member 620. As shown in the illustrated example, the driver head 618 and the clamp member 620 may be coupled to the elongated body 614. In some examples, the driver head 618 and / or the clamping portion 620 may be friction fit, welded, or otherwise coupled to the elongated body 614. In some examples, the driver head 618 and the elongated body 614 may be integrally formed with each other. The engagement portion 616 may be coupled to the elongated body 614 using any of the structures / methods previously described for the clamp member 546 and / or the driver head 544.

[0172] refer to Fig.33 The driver head 618 may include 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 periphery of the driver head 618. Fig.31 As can be seen, the protrusion 626 can include an elongated rectangular prism shape including chamfered side edges. In some examples, the protrusion 626 can have any of a variety of other shapes.

[0173] The engagement member 624 can extend distally from the body 622 and can be configured to engage with a recess 718 of a corresponding threaded rod 702. Although in the illustrated example, the cross-section of the engagement member 624 is square, in some examples, the engagement member 624 can have any of a variety of non-circular shapes, such as rectangular, triangular, oval, star-shaped, etc. The recess 718 in the head portion 712 of the threaded rod 702 can be correspondingly shaped to receive the engagement member 624. The shape of the engagement member 624 and the corresponding recess 718 can, for example, advantageously improve the torque transmission from the driver 604 to the threaded rod 702.

[0174] Reference now Fig.31 , the gripper member 620 can include an annular base member 628 and one or more extension members / wings / arms 630 configured similar to a chuck or collet. The collet-shaped arms 630 can be disposed around the head portion 712 of the threaded rod 702 to releasably engage the actuator assembly 600 with the actuator mechanism 704 of the frame 700. The arms 630 can be movable between an expanded configuration (e.g., when the outer sleeve 602 moves proximally relative to the arms 630) and a compressed configuration (e.g., when the outer sleeve 602 is advanced distally over the arms 630).

[0175] refer to Fig.33 , the arms 630 can extend distally from the base member 628 and can each include a wider end portion 632 (also referred to as a protrusion, projection, or tooth 632) disposed at a distal end portion of the arms 630 and extending radially inward toward the longitudinal axis of the driver 604. The teeth 632 can be configured (e.g., sized and shaped) to be positioned within the circumferential recess 720 of the head portion 712 when the actuator assembly 600 is coupled to the frame 700, as shown. Fig.33 As shown, the tooth 632 may include an angled or inclined proximal surface 634 ( Fig.34), the proximal surface may correspond to the chamfered surface 724 of the circumferential recess 720. Such a configuration may advantageously allow the arm 630 to easily slide into and / or out of engagement with the circumferential recess 720. Fig.33 As shown, the distal portion 636 of each arm 630 can be radially flared outward (e.g., away from the longitudinal axis of the driver 604) such that the distal portion 636 extends radially outward relative to the body 638 of the arm 630 and such that the outer surface of the distal portion 636 is radially spaced outward from the outer surface of the body 638. In other words, the radial thickness of the distal portion 636 of each arm 630 can be thicker than the radial thickness of the body 638 of the arm 630, as shown in FIG. Fig.33 Such a configuration may improve the engagement of the teeth 632 with the circumferential recess 720 by increasing the contact between the outer sleeve 602 and the distal end portion 636 .

[0176] The arms 630 can be configured to be biased radially outward (e.g., away from the longitudinal axis of the driver 604) into an expanded shape, such as by shaping the arms 630 using any of a variety of known methods. In the illustrated example, the gripper member 620 includes four arms, which advantageously distribute the engagement force more evenly around the circumference of the head portion 712. However, in some examples, the gripper member 620 can include any number of arms 630, such as one, two, three, four, five, six, seven, eight, etc.

[0177] like Fig.32 As can be seen, the distal portion 636 of each arm 630 can have an increased circumferential width relative to the body 638 of the arm 630. The increased width can advantageously improve the engagement of the distal portion 636 with the circumferential recess 720 of the head portion 712. The cross-sectional shape of each arm 630 can be arcuate in the circumferential direction (i.e., a cross-section of each arm taken in a plane perpendicular to the longitudinal axis of the arm can be curved), which can, for example, help the arm 630 resist bending in the circumferential direction. The narrower body 638 of the arm 630 reduces the bending width, so that the arm 630 can, for example, bend radially more easily (e.g., when the arm is pulled toward or away from engagement with the head portion 712).

[0178] like Fig.31 As can be seen, the protrusions 626 of the driver head 618 can extend between the arms 630 so that when the actuator assembly 600 is engaged with the frame 700, the arms 630 are located within the recesses defined between the protrusions 626. The protrusions 626 can, among other things, retain the arms in the engaged configuration and / or prevent lateral displacement of the arms 630, thereby improving the stability of the arms 630 without requiring the arms to be welded or otherwise secured around the driver head 618. This can, for example, advantageously maintain engagement stability without requiring welding of such small components.

[0179] In some examples, the actuator assembly 600 can be coupled to a corresponding actuator mechanism 704 of a 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 are advanced over the head portion 712 until the teeth 632 are seated within the circumferential recesses 720 and the engagement members 624 of the driver 604 are seated within the central recess 718. As the outer sleeve 602 is advanced over the driver 604 (e.g., distally), the distal 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 Fig.33 ). The outer sleeve 602 may continue to advance until the support extension 608 engages with the radial inner and outer surfaces of the frame 700, as shown. Fig.30 So coupled, the driver 604 can be rotated (e.g., using a 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 the torque transfer between the driver 604 and the threaded rod 702.

[0180] So coupled, the delivery device and prosthetic valve can be advanced over the guidewire through the patient's vasculature to a selected implantation site (e.g., a native aortic annulus). For example, when implanting a prosthetic valve within a native aortic valve, the delivery device and prosthetic valve can be inserted into and passed through the femoral artery, through the aorta, and to the native aortic valve. The prosthetic valve can then be deployed at the implantation site (e.g., within the native aortic valve) and can be expanded and locked in an expanded configuration using the actuator mechanism 704.

[0181] refer to Figure 30-32 ( Figure 33-35 ), once final positioning and expansion of the prosthetic valve is achieved, the actuator assembly 600 can be released from the prosthetic valve in the following exemplary manner. The outer sleeve 602 can be retracted to expose the connection between the driver 604 and the threaded rod 702, such as Fig.31 and 34 With the outer sleeve proximal relative to the distal end portion 636 of the arm 630, the arm 630 can move radially outward (e.g., due to being shaped into 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 can, for example, help promote radial expansion of the arm 630 as the arm 630 moves proximally from the circumferential recess 720. The driver 604 can then be moved as shown. Fig.32 and 35600 is retracted, thereby removing engagement member 624 from recess 718 of stem 702, thereby decoupling driver 604 from stem 702. At this stage, the delivery apparatus (including actuator assembly 600) can be retracted relative to the prosthetic valve and removed from the patient.

[0182] Figure 36-41 An actuator assembly 800 ( FIG. 1 ) of a delivery device that can be used to radially expand and / or compress a prosthetic valve is shown. Fig.39 ). The actuator assembly 800 can be similar to the previously described actuator assemblies 500 and 600, except that the one or more arms / extension members / wings 838 of the gripper member 818 can have a uniform thickness, which advantageously makes it easier to manufacture without requiring a rod turning procedure. The gripper member 818 can also be configured to advantageously couple to the driver 804 without requiring welding, as described in more detail below.

[0183] Figure 39-41 Actuator assembly 800 is shown used on a portion of an exemplary frame 902 of a prosthetic valve 900, however, actuator assembly 800 can be used on any of the prosthetic valves described herein and / or on any other prosthetic valve having a similar expansion mechanism. Although only a portion of frame 902 is shown, it should be understood that frame 902 is an annular structure that can support a valve structure and can include an inner skirt and / or an outer skirt to form a prosthetic heart valve 900 similar to prosthetic heart valve 400.

[0184] The actuator assembly 800 can be a component of a delivery device (such as the delivery device 100 previously described) and can be configured to releasably couple and actuate a corresponding actuator / screw / actuation bolt / threaded rod of a prosthetic valve 900, such as the threaded rod 904 of the actuator mechanism 906, partially shown in FIG. Figure 39-41 . The actuator mechanism 906 can be the same or similar to the actuator mechanisms 206, 406, and / or 704 described previously. The rod 904 can 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 can include a plurality of actuator assemblies 800, one for each rod 904 of the prosthetic valve 900. The delivery device can include any number of actuator assemblies (e.g., 1-15 actuator assemblies). The number of actuator assemblies of the delivery device can be determined, for example, by the number of threaded rods of the prosthetic valve that the delivery device is being used to implant.

[0185] refer to Fig.36, the rod 904 may include an elongated body 908 (partially shown) and a head portion 910 configured to be releasably coupled to the corresponding actuator assembly 800. The elongated body 908 may include a threaded portion (not shown). The head portion 910 may have a generally Ω-shape and an open base portion 918, the generally Ω-shape including a protrusion 912, the protrusion including a protrusion head 914 and a protrusion neck 916. The width W1 of the protrusion head 914 may be greater than the width W2 of the protrusion neck 916. The protrusion 912 and the open base portion 918 may together define a first curved recess and a second curved recess 920 on opposite sides of the head portion 910. As shown Fig.41 As shown, the diameter D1 of the flared base portion 918 can be greater than the diameter D2 of the opening 922 in the frame 902 so that the head portion 910 is prevented from moving into the frame 902 and causes the head portion 910 to abut the outflow edge of the frame, such as Fig.41 The head portion 910 of the rod 904 can be used to apply a distally directed force to the frame 902, for example, during radial expansion of the frame 902.

[0186] Rotation of the threaded rod 904 relative to the frame 902 (e.g., using the actuator assembly 800 of the delivery device) causes relative axial movement between the inflow end and the outflow end of the frame 902, which in turn causes radial expansion or compression of the frame. For example, moving the inflow end and the outflow end toward each other (by rotation of the rod 904 in a first direction) causes the frame 902 to shorten axially and expand radially. In contrast, moving the inflow end and the outflow end away from each other (by rotation of the rod 904 in a second direction) causes the frame 902 to lengthen axially and compress radially.

[0187] refer to Figure 39-41 Each actuation assembly 800 may include a first actuation member ( Figure 39-40 804) and a second actuating member configured as a driver 804. The driver 804 can extend through the outer sleeve 802, as shown. The outer sleeve 802 and the distal end portion of the driver 804 can be configured to engage or abut with the head portion 910 of the rod 904 and / or a portion of the frame 902.

[0188] The outer sleeve 802 and the proximal portion of the driver 804 can be operatively coupled to a handle of a delivery device (e.g., the handle 104 of the delivery device 100). The delivery device in this example can include the same or similar features previously described for the delivery device 100. In some examples, the proximal portion of each driver 804 can be operatively coupled to the knob 112, such that rotation of the knob 112 (clockwise or counterclockwise) causes a corresponding rotation of the driver 804. The proximal portion of each outer sleeve 802 can be operatively coupled to the knob 114, such that rotation of the knob 114 (clockwise or counterclockwise) causes a corresponding axial movement of the sleeve 802 (proximally or distally) relative to the driver 804. In some examples, the handle can include a motor, button, switch, circuitry, etc. for actuating these components.

[0189] refer to Fig.39 , the distal portion 806 of the outer sleeve 802 may include a first support extension and a second support extension 808 defining a gap or notch 810 therebetween. The support extension 808 and notch 810 may function in the same or similar manner as described previously for the support extension 534 / 608 and notch 535 / 610.

[0190] The driver 804 may include an elongated 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 clamp member 818.

[0191] refer to Fig.37 , the driver head 816 may include a body 820 including a first end portion 822 having a first end surface 824 and a second end portion 826 having a second end surface 828, and first and second shoulders 830 extending radially outward from a second end portion 826. In some examples, as shown, the body 820 may be substantially cylindrical.

[0192] like Fig.41 As shown, the second end surface 828 may include an engagement recess 832 that extends into the body 820 and is configured (e.g., sized and shaped) to engage with the protrusion head 914 of the rod 904. The cross-section of the engagement recess 832 may be substantially semicircular. Fig.37 and 39-40, the shoulder 830 can include a notch 834 (e.g., a semicircular notch) configured to (e.g., sized and shaped to) engage with the protrusion head 914. In some examples, the cross-sections of the engagement recess 832 and the notch 834 can be any of a variety of shapes, such that the engagement recess and the notch are 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, for example, advantageously improve torque transmission from the driver 804 to the rod 904.

[0193] Reference now Fig.38 , the clamp member 818 can include an annular base member 836 and one or more extension members / wings / arms 838. In the illustrated example, the clamp member 818 has first and second diametrically opposed arms 838, which define first and second diametrically opposed recesses 840 therebetween. The recess 840 can have an omega shape so that it substantially corresponds to the omega shape of the head portion 910 of the rod 904. In some examples, the clamp member 818 can have any number of arms and any number of recesses. In some examples, the arms 838 can be movable between an extended 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 above the arms 838).

[0194] As shown, the arm 838 can extend distally from the base member 836 and can include a proximal neck portion 842 having a first circumferential width and a distal portion 844 having a second, wider circumferential width. The distal portion 844 can include a circumferentially extending curved protrusion 846 that is configured to be seated within the curved recess 920 of the rod head 910 so that the clamp member 818 engages with the rod 904, as shown. Fig.40 As shown. The increased width of the distal portion 844 including the curved protrusion 846 can advantageously improve the engagement of the distal portion 844 with the curved recess 920 of the rod head 910. The cross-sectional shape of each arm 838 can be arcuate in the circumferential direction (i.e., a cross-section of each arm taken in a plane perpendicular to the longitudinal axis of the arm can be curved), which can, for example, help the arm 838 resist bending in the circumferential direction. The narrower neck portion 842 of the arm 838 reduces the bending width, so that the arm 838 can, for example, be more easily bent radially (e.g., when the arm is pulled toward or away from engagement with the head portion 910).

[0195] As can be seen in e.g. Fig.41804 , the arms 838 are uniform in thickness from the base member 836 to the distal portion 844, unlike the arms 630 of the holder member 620. Such a configuration advantageously allows the holder member 818 to be more easily manufactured, for example, using laser cutting and shape setting (e.g., heat setting) of the arms, without requiring a rod rotation procedure. In some examples, the holder member 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 using any of a variety of known methods to shape setting (e.g., heat setting) the arms 838. In the illustrated example, the holder member 818 includes two arms 838, however, in some examples, the holder member can include any number of arms.

[0196] The driver head 816 and the clamp member 818 can each be coupled to the elongated body 812 of the driver 804. For example, Figure 39-41 As shown, the driver 804 can include a coupling member 848 (e.g., a cylindrical tube) coupled (e.g., welded) to the elongated body 812 at a first end portion 850 and coupled to the driver head 816 at a second end portion 852. As can be seen in, for example, Fig.41 As seen in FIG. 8 , the clamp member 818 can be positioned over the driver head 816 at a location distal to the coupling member 848 such that the proximal edge 854 of the annular base member 836 abuts the distal edge 856 of the coupling member 848. Fig.40 As shown, this positions the shoulder 830 of the driver head 816 within the corresponding proximal portion 858 of the corresponding recess 840. The gripper member 818 is thereby restricted from axial and rotational movement relative to the driver head 816 and the elongated body 812 by the engagement of the shoulder 830 and the distal edge portion 856 of the coupling member 848. Thus, the gripper member 818 is advantageously coupled to the elongated body 812 without the need for welding, which simplifies the manufacturing process.

[0197] In some examples, the driver head 816 and / or the gripper member 818 can be friction fit, welded, or otherwise coupled to the elongated body 812. In some examples, the driver head 816 and the elongated body 812 can be integrally formed with each other. In some examples, the engagement portion 814 can be coupled to the elongated body 812 using any of the structures / methods previously described for the gripper members 546 / 620 and / or the driver head 544 / 618.

[0198] In some examples, the actuator assembly 800 can be coupled to a corresponding actuator mechanism 906 of a prosthetic valve as follows. 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 arm 838 can be deflected radially outward as it is advanced over the head portion 910 until the curved protrusion 846 is seated within the curved recess 920 of the rod head 910 and the engagement recess 832 of the driver head 816 engages with the protrusion head 914 of the rod. As the outer sleeve 802 is advanced over the engagement portion 814 (e.g., distally), the distal end portion 844 of the arm 838 is radially compressed, thereby retaining the curved protrusion 846 within the curved recess 920 and coupling the actuator assembly 800 to the rod 904 (e.g., as shown in FIG. 1 ). Figure 40-41 ). The outer sleeve 802 may continue to advance until the support extension 808 engages the radial inner and outer surfaces of the frame 902, such as, for example Fig.40 So coupled, the driver 804 can be rotated (e.g., using the handle of the delivery device 100) to cause a corresponding rotation of the rod 904. The engagement between the actuator assembly 800 and the rod 904 can advantageously improve the torque transfer between the driver 804 and the threaded rod 904.

[0199] So coupled, the delivery device and prosthetic valve can be advanced over the guidewire through the patient's vasculature to a selected implantation site (e.g., a native aortic annulus). For example, when implanting a prosthetic valve within a native aortic valve, the delivery device and prosthetic valve can be inserted into and passed through the femoral artery, through the aorta, and to the native aortic valve. The prosthetic valve can then be deployed at the implantation site (e.g., within the native aortic valve) and can be expanded and locked in an expanded configuration using the actuator mechanism 704.

[0200] Once the final positioning and expansion of the prosthetic valve is achieved, the actuator assembly 800 can be released from the prosthetic valve in the following exemplary manner. The outer sleeve 802 can be retracted to expose the connection between the driver 804 and the rod 904. In the case where the outer sleeve is proximal relative to the distal portion 844 of the arm 838, the arm 838 can move radially outward (for example, due to the shape being set to a radially expanded / disengaged state). The driver 804 can then be retracted, thereby removing the engagement recess 832 of the driver head 816 from the protrusion head 914, thereby disengaging the driver 804 from the rod 904. At this stage, the delivery device (including the actuator assembly 800) can be retracted relative to the prosthetic valve and removed from the patient's body.

[0201] In some cases, an outer sleeve (such as outer sleeve 302, 524, 602, or 802 previously described) 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. Figure 42-46In some examples, any of the actuation assemblies described herein may include an outer sleeve 1000, at least a portion of which is configured as a hypotube 1002, in place of or in addition to the outer sleeves 302, 524, 602, and 802 described previously. For purposes of illustration, Fig.44 The outer sleeve 1000 is shown transparently. The hypotube 1002 can be expanded and compressed between a first length and a second length. During use, the outer sleeve 1000 can be initially positioned around an actuator (e.g., any of the actuators described herein) in a compressed configuration so that even if the outer sleeve 1000 and the actuator are bent during delivery or use, the outer sleeve 1000 can be advantageously biased into an expanded configuration in which the arms of the actuator remain covered and thus restrained.

[0202] like Fig.42 As shown, 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 spaced apart from one another by circumferentially extending members or ribs 1006. As mentioned, the hypotube 1002 may be movable between an expanded configuration having a first overall length, in which the ribs are spaced apart from one another by a first distance D1 ( Fig.45 ), in the compressed configuration the ribs are spaced apart from each other by a second distance D2 shorter than the first distance ( Fig.46 ). Although the difference between D1 and D2 may be very slight (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 at most). The hypotube 1002 may be configured to be biased into an expanded configuration. In some examples, the hypotube 1002 may be a laser cut tube.

[0203] The diamond-shaped slots 1004 can be configured (e.g., sized and shaped) to provide the desired elongation and resulting force. For example, the slots 1004 can be configured to provide less force but greater elongation. The axial preload of the hypotube portion prevents or mitigates undesirable 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 space available to do so. In some cases, undesirable movement can undesirably cause the actuator assembly to decouple from the prosthetic valve, and it is therefore important to mitigate such movement.

[0204] In some examples, the outer sleeve 1000 can further be used to visually indicate to the physician that the actuator assembly has been successfully released from the prosthetic valve. For example, this can be accomplished by releasing a mechanical latch at the proximal end of the loaded outer sleeve. Once the latch is released, the proximal portion of the outer sleeve can be expanded in a proximal direction (e.g., toward the physician) and not only release the outer sleeve from the prosthetic valve, but also move 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 that will be visible on an X-ray screen.

[0205] For example Fig.43 As shown, the outer sleeve 1000 may include a first elongated portion 1008 including a hypotube 1002 and a non-hypotube second portion 1010 at its distal end. The second portion 1010 may include a first support extension and a second support extension 1012 that define a gap or notch 1014 therebetween. The support extension 1012 and the notch 1014 may function in the same or similar manner as described previously with respect to the support extension 608 / 534 / 808 and the notch 610 / 535 / 810. For example, as described above, the outer sleeve 1000 may include a first elongated portion 1008 including a hypotube 1002 and a non-hypotube second portion 1010 at its distal end. The second portion 1010 may include a first support extension and a second support extension 1012 that define a gap or notch 1014 therebetween. The support extension 1012 and the notch 1014 may function in the same or similar manner as described previously with respect to the support extension 608 / 534 / 808 and the notch 610 / 535 / 810. Fig.43 As shown, the first support extension 1012 can extend partially over the radially inner surface 1016 of the frame 1018 of the prosthetic valve 1020, and the second support extension 1012 can extend partially over the radially outer surface 1022 of the frame 1018 to limit the rotation of the frame 1018 relative to the actuator assembly. In some examples, the distal portion 1010 of the outer sleeve 1000 can include a material and / or construction different from the material and / or construction of the first portion.

[0206] During delivery and / or use, outer sleeve 1000 including hypotube 1002 can be axially preloaded so that it rests in a compressed configuration over an actuator (such as actuators 304, 526, 604, or 804 described herein). If the outer sleeve bends during delivery or use, hypotube portion 1002 advantageously expands, allowing distal portion 1010 to remain positioned over the arm, thus preventing the arm from inadvertently expanding.

[0207] Any of the systems, devices, equipment, etc. herein can be sterilized (e.g., with heating / heat, pressure, steam, radiation, and / or chemicals, etc.) to ensure that it is safe for use with patients, and as one of the steps of the method, pressure, steps, any of the methods herein can include sterilization of the associated system, device, equipment, etc. Examples of heating / thermal sterilization include steam sterilization and autoclave sterilization. Examples of radiation used for sterilization include, but are not limited to, gamma radiation, ultraviolet radiation, and electron beams. Examples of chemicals used for sterilization include, but are not limited to, ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde, and glutaraldehyde. For example, sterilization using hydrogen peroxide can be accomplished using hydrogen peroxide plasma.

[0208] The therapeutic techniques, methods, steps, etc. described or suggested herein or incorporated by reference herein may be performed on living animals or non-living mimics, such as cadavers, cadaver hearts, anthropomorphic ghosts, simulated bodies (e.g., utilizing simulated body parts, tissues, etc.), and the like.

[0209] Additional Examples of the Disclosed Technology

[0210] Considering the above-mentioned embodiments of the disclosed subject matter, the present application discloses the additional examples listed below. It should be noted that one feature of a separate example or one or more features of the examples adopted in combination, and optionally combined with one or more features of one or more additional examples, are additional examples that also fall within the disclosure of the present application.

[0211] Example 1. An assembly comprising:

[0212] A prosthetic heart valve, the prosthetic heart valve comprising:

[0213] A radially expandable and compressible frame having an inflow end portion, an outflow end portion, and a plurality of actuator mechanisms, each actuator mechanism comprising:

[0214] a first frame member having a first internal bore and a second frame member having a second internal bore, the first frame member and the second frame member being axially spaced from each other, and

[0215] an actuator having an externally threaded surface and extending through the first inner bore and the second inner bore; and

[0216] A delivery device, the delivery device comprising:

[0217] handle,

[0218] one or more actuator assemblies extending from the handle, each actuator assembly comprising:

[0219] a first actuation member having a distal portion releasably coupled to the outflow end portion of the frame, the distal portion including a first support extension and a second support extension; and

[0220] a second actuation member extending through the first actuation member and including a distal portion having an engagement portion releasably coupled to the rod;

[0221] wherein rotation of the second actuation member in a first direction causes corresponding rotation of the rod such that the first member and the second member move axially toward each other to expand the prosthetic valve; and

[0222] Wherein during expansion of the prosthetic valve, the first support extension and the second support extension inhibit rotation of the frame relative to the one or more actuator assemblies.

[0223] Example 2. The assembly of any example herein, in particular example 1, wherein the first support extension extends partially over a radially inner surface of the frame, and the second support extension extends partially over a radially outer surface of the frame.

[0224] Example 3. An assembly according to any of any of the examples herein, particularly any of examples 1 to 2, wherein the proximal portion of the actuator includes a first protrusion and a second protrusion defining a slot therebetween.

[0225] Example 4. The assembly of any example herein, particularly example 3, wherein the engagement portion comprises a central protrusion extending into the slot.

[0226] Example 5. The assembly of any example herein, in particular example 4, wherein the central protrusion is sized so that it does not contact an inner surface of the first actuation member.

[0227] Example 6. An assembly according to any example herein, in particular any one of examples 1 to 5, wherein the proximal portion of the actuator includes one or more shoulders extending radially from a surface of the actuator.

[0228] Example 7. The assembly of any example herein, particularly example 6, wherein the engagement portion comprises one or more flexible elongated elements releasably coupled to the shoulder.

[0229] Example 8. The assembly of any example herein, particularly example 7, wherein each elongated element comprises a protrusion extending radially inwardly toward a longitudinal axis of the second actuation member.

[0230] Example 9. The assembly of any example herein, particularly example 7, wherein the one or more elongated elements are offset radially outward from a longitudinal axis of the second actuation member.

[0231] Example 10. An assembly according to any example herein, particularly any one of Examples 1 to 9, wherein rotation of the second actuating member along a second direction causes a corresponding rotation of the actuator such that the first frame member and the second frame member move axially away from each other to radially compress the prosthetic valve.

[0232] Example 11. According to any example herein, in particular the assembly described in any one of Examples 1 to 10, each actuator includes a stopper axially disposed between the first frame member and the second frame member, the stopper being configured to selectively abut the inflow end portion of the second frame member to prevent excessive curling of the frame.

[0233] Example 12. According to any example herein, in particular the assembly described in any one of Examples 1 to 11, each first frame member includes a nut disposed at the outflow end portion of the first frame member, the nut including an internal threaded hole configured to engage with the external threaded surface of the actuator.

[0234] Example 13. The assembly of any example herein, particularly example 12, wherein the nut is visible through a window extending through a wall of the first member.

[0235] Example 14. According to any example herein, in particular the assembly of any one of examples 1 to 13, the frame comprises a plurality of circumferentially disposed hexagonal units.

[0236] Example 15. The assembly of any example herein, particularly example 14, wherein each hexagonal cell comprises a diamond-shaped cell disposed within an outer perimeter of the hexagonal cell.

[0237] Example 16. The assembly of any example herein, particularly example 15, wherein each hexagonal unit and diamond unit comprises an inflow vertex and an outflow vertex, and wherein each actuator extends through the inflow vertex and the outflow vertex.

[0238] Example 17. An assembly according to any example herein, particularly any one of examples 1 to 16, wherein the frame further comprises one or more axially extending support columns.

[0239] Example 18. An assembly according to any example herein, particularly any one of examples 1 to 17, wherein the plurality of actuator mechanisms are each coupled to one or more support columns via a plurality of struts.

[0240] Example 19. An assembly according to any example herein, in particular example 18, wherein the struts are curled.

[0241] Example 20. An assembly according to any example herein, particularly any one of examples 18 to 19, wherein each strut has a recurved shape comprising a first portion and a second portion separated by an inflection point.

[0242] Example 21. An assembly according to any example herein, in particular example 20, wherein the first portion is an upwardly curved portion, and the second portion is a downwardly curved portion.

[0243] Example 22. An assembly according to any example herein, in particular any one of Examples 18 to 21, wherein each support post comprises a first end portion and a second end portion, and wherein the first end portion and the second end portion terminate asymptotically at at least one of the corresponding support column and the actuator mechanism.

[0244] Example 23. An assembly according to any example herein, particularly any one of examples 1 to 22, wherein each actuator is configured as at least one of a right-hand stick and a left-hand stick.

[0245] Example 24. An assembly according to any example herein, in particular Example 23, wherein the prosthetic heart valve comprises six actuator mechanisms, and wherein the actuators of the actuator mechanisms alternate between right-hand and left-hand levers around the circumference of the frame.

[0246] Example 25. An assembly comprising:

[0247] A prosthetic heart valve, the prosthetic heart valve comprising:

[0248] A radially expandable and compressible frame having an inflow end portion and an outflow end portion, the frame comprising a plurality of actuation mechanisms, each actuation mechanism comprising:

[0249] a first frame member having a first internal bore and a second frame member having a second internal bore, the first frame member and the second frame member being axially spaced from each other, and

[0250] a rod having an externally threaded surface and extending through the first and second inner bores, a proximal end portion of the rod including first and second protrusions defining a slot therebetween, and first and second shoulders; and

[0251] A delivery device, the delivery device comprising:

[0252] handle,

[0253] one or more actuator assemblies extending from the handle, each actuator assembly comprising:

[0254] a first actuation member, a distal end portion of the first actuation member abutting the outflow end portion of the frame, and

[0255] a second actuation member extending through the first actuation member, the second actuation member including a distal portion of a central projection extending into the slot, and first and second flexible elongated elements releasably coupled to the shoulder; and

[0256] wherein rotation of the second actuation member in a first direction causes corresponding rotation of the rod such that the first frame member and the second frame member move axially toward each other to expand the prosthetic valve.

[0257] Example 26. An assembly according to any example herein, in particular Example 25, wherein the first actuation member further includes a first support extension and a second support extension, wherein the support extensions are configured to inhibit rotation of the frame relative to the first actuation member during expansion of the frame.

[0258] Example 27. The assembly of any example herein, particularly Example 26, wherein the first support extension extends partially over a radially inner surface of the frame, and the second support extension extends partially over a radially outer surface of the frame.

[0259] Example 28. An assembly according to any example herein, particularly any one of examples 25 to 27, wherein the central protrusion is sized so that it does not contact an inner surface of the first actuation member.

[0260] Example 29. The assembly of any example herein, particularly any one of examples 25 to 28, wherein each elongated element comprises a protrusion extending radially inwardly.

[0261] Example 30. The assembly of any example herein, in particular example 29, wherein the one or more elongated elements are offset radially outward from a longitudinal axis of the second actuation member.

[0262] Example 31. An assembly according to any example herein, particularly any one of Examples 25 to 30, wherein rotation of the second actuating member along a second direction causes a corresponding rotation of the rod such that the first frame member and the second frame member move axially away from each other to radially compress the prosthetic valve.

[0263] Example 32. According to any example herein, in particular the assembly described in any one of Examples 25 to 31, each rod includes a stopper disposed between the first frame member and the second frame member, the stopper being configured to selectively abut the inflow end portion of the second frame member to prevent excessive curling of the frame.

[0264] Example 33. According to any example herein, in particular the assembly of any one of Examples 25 to 32, each first frame member includes a nut disposed at the outflow end portion of the first member, the nut including an internal threaded hole configured to engage with the threaded rod.

[0265] Example 34. An assembly according to any example herein, particularly example 33, wherein the nut is visible through a window extending through a wall of the first frame member.

[0266] Example 35. The assembly according to any example herein, in particular any one of examples 25 to 34, further comprising a plurality of columns;

[0267] wherein one or more of the columns are configured as the actuation mechanism; and

[0268] The plurality of columns are connected to each other by a plurality of struts.

[0269] Example 36. An assembly according to any example herein, particularly Example 35, wherein the struts are curled.

[0270] Example 37. An assembly according to any example herein, particularly any one of examples 25 to 26, wherein each strut has a recurved shape comprising a first portion and a second portion separated by an inflection point.

[0271] Example 38. An assembly according to any example herein, in particular example 37, wherein the first portion is an upwardly curved portion, and the second portion is a downwardly curved portion.

[0272] Example 39. An assembly according to any example herein, particularly any one of Examples 25 to 38, wherein each strut comprises a first end portion and a second end portion, and wherein the first end portion and the second end portion terminate asymptotically at a respective column.

[0273] Example 40. A delivery device comprising:

[0274] handle,

[0275] one or more actuator assemblies extending from the handle, each actuator assembly comprising:

[0276] a first actuation member having a distal portion configured to abut an outflow end portion of a prosthetic heart valve, the distal portion including a first support extension and a second support extension; and

[0277] a second actuation member extending through the first actuation member and having a distal portion configured to releasably couple to an actuator of the prosthetic heart valve;

[0278] wherein rotation of the second actuation member in a first direction causes radial expansion of the prosthetic valve, and rotation of the second actuation member in a second direction causes radial compression of the prosthetic valve; and

[0279] Wherein the first support extension is configured to extend partially over a radially inner surface of the prosthetic valve, and the second support extension is configured to extend partially over a radially outer surface of the prosthetic valve to inhibit rotation of the frame of the prosthetic valve relative to the actuator assembly.

[0280] Example 41. A delivery device according to any example herein, particularly Example 40, wherein the second actuation member comprises a central protrusion.

[0281] Example 42. The delivery device of any example herein, particularly Example 41, wherein the central protrusion is sized so that it does not contact an inner surface of the first actuation member.

[0282] Example 43. A delivery device according to any example herein, particularly any one of Examples 40 to 42, wherein the distal portion of the second actuation member comprises one or more flexible elongated elements.

[0283] Example 44. The delivery device of any example herein, particularly Example 43, wherein each elongated element comprises a protrusion extending radially inwardly toward a longitudinal axis of the second actuation member.

[0284] Example 45. The delivery device of any example herein, particularly Example 44, wherein the one or more elongated elements are offset radially outward from a longitudinal axis of the second actuation member.

[0285] Example 46. An implantable prosthetic device comprising:

[0286] A radially expandable and compressible frame having an inflow end portion and an outflow end portion, the frame comprising:

[0287] A plurality of columns, one or more of which are configured as an actuation mechanism, the actuation mechanism comprising:

[0288] a first frame member having a first inner hole,

[0289] a second frame member having a second internal bore, the first frame member and the second frame member being axially spaced from each other, and

[0290] an actuator having an externally threaded surface and extending through the first and second inner bores, a proximal end portion of the actuator including first and second protrusions defining a slot therebetween, and first and second shoulders extending radially from an outer surface of the actuator; and

[0291] a plurality of struts coupling adjacent struts to one another; and

[0292] Wherein rotation of the actuator in a first direction causes axial movement of the first frame member and the second frame member toward each other to radially expand the prosthetic device.

[0293] Example 47. The prosthetic device of any example herein, in particular Example 46, further comprising a valve structure comprising a plurality of leaflets disposed within the frame.

[0294] Example 48. The prosthetic device of any example herein, particularly any one of Examples 46 to 47, wherein rotation of the actuator in the second direction causes axial movement of the first member and the second member away from each other to radially compress the prosthetic device.

[0295] Example 49. In accordance with any example herein, in particular the prosthetic device described in any one of Examples 46 to 48, each actuator includes a stopper axially disposed between the first frame member and the second frame member, the stopper being configured to selectively abut an inflow end portion of the second frame member to prevent excessive curling of the frame.

[0296] Example 50. According to any example herein, in particular the prosthetic device described in any one of Examples 46 to 49, each first frame member includes a nut disposed at an outflow end portion of the first frame member, the nut including an internal threaded hole configured to engage with the external threaded surface of the rod.

[0297] Example 51. According to any example herein, particularly Example 50, wherein the nut is visible through a window extending through the wall of the first frame member.

[0298] Example 52. According to any example herein, in particular the prosthetic device of any one of Examples 46 to 51, the struts and columns define a plurality of circumferentially disposed hexagonal units.

[0299] Example 53. A prosthetic device according to any example herein, in particular Example 52, wherein each hexagonal cell includes a diamond-shaped cell disposed within an outer perimeter of the hexagonal cell.

[0300] Example 54. The prosthetic device of claim 53 wherein each hexagonal cell and diamond-shaped cell comprises an inflow vertex and an outflow vertex, and wherein each actuation mechanism extends through the inflow vertex and the outflow vertex.

[0301] Example 55. A prosthetic device according to any example herein, particularly any one of Examples 46 to 54, wherein each strut is curved.

[0302] Example 56. A prosthetic device according to any example herein, particularly any one of Examples 46 to 55, wherein each strut has a recurved shape comprising a first portion and a second portion separated by an inflection point.

[0303] Example 57. A prosthetic device according to any example herein, in particular Example 56, wherein the first portion is an upwardly curved portion and the second portion is a downwardly curved portion.

[0304] Example 58. A prosthetic device according to any example herein, particularly any one of Examples 46 to 57, wherein each strut comprises a first end portion and a second end portion, and wherein the first end portion and the second end portion terminate asymptotically at respective posts.

[0305] Example 59. A method comprising:

[0306] inserting a distal end of a delivery device into the vasculature of a patient, the delivery device releasably coupled to a prosthetic heart valve via a plurality of actuator assemblies, the prosthetic heart valve comprising a frame, the frame comprising a plurality of actuation mechanisms, the plurality of actuation mechanisms each comprising a first frame member, a second frame member axially spaced from the first frame member, and an actuator extending through the first frame member and the second frame member, 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 the outflow end of the actuator, the first actuation member comprising a first support extension extending partially over a radially inner surface of the frame and a second support extension extending partially over and through a radially upper surface of the frame;

[0307] advancing the prosthetic valve to a selected implantation site; and

[0308] The second actuating member is rotated to cause a corresponding rotation of the actuator, thereby causing the first frame member and the second frame member to move axially toward each other to radially expand the prosthetic valve, and the first support extension and the second support extension inhibit rotation of the frame relative to the first actuating member during expansion.

[0309] Example 60. According to any example herein, in particular the method of example 59, further comprising:

[0310] Rotating the second actuating member in a second direction causes corresponding rotation of the actuator, thereby causing axial movement of the first frame member and the second frame member away from each other to radially compress the prosthetic valve, and the first support extension and the second support extension inhibit rotation of the frame relative to the first actuating member during compression of the frame.

[0311] Example 61. A method according to any example herein, specifically any one of Examples 59 to 60, wherein the actuator includes a stopper disposed between the first frame member and the second frame member, and wherein during radial compression of the frame, the stopper selectively abuts the inflow end of the second frame member.

[0312] Example 62. An assembly comprising:

[0313] A prosthetic heart valve, the prosthetic heart valve comprising:

[0314] a radially expandable and compressible frame having an inflow end portion and an outflow end portion, and

[0315] one or more actuators having an externally threaded surface and configured to radially expand the frame when the one or more actuators are rotated; and

[0316] A delivery device, the delivery device comprising:

[0317] handle,

[0318] one or more actuator assemblies extending from the handle, each actuator assembly comprising:

[0319] a first actuation member having a distal portion releasably coupled to the outflow end portion of the frame, the distal portion including a first support extension and a second support extension; and

[0320] a second actuation member extending through the first actuation member and comprising a distal portion having an engagement portion comprising:

[0321] a driver head having an engagement member extending into a corresponding recess in a corresponding actuator, and

[0322] a gripper member comprising one or more arms releasably coupled to one or more protrusions extending from the actuator;

[0323] wherein rotation of the second actuation member in a first direction causes corresponding rotation of the actuator to radially expand the prosthetic valve; and

[0324] Wherein during expansion of the prosthetic valve, the first support extension and the second support extension inhibit rotation of the frame relative to the one or more actuator assemblies.

[0325] Example 63. An assembly according to any example herein, in particular Example 62, wherein the first support extension extends partially over a radially inner surface of the frame, and the second support extension extends partially over a radially outer surface of the frame.

[0326] Example 64. An assembly according to any example herein, particularly any one of examples 62 to 63, wherein the cross-section of the joining portion is a square with chamfered corners.

[0327] Example 65. The assembly of any example herein, particularly Example 64, wherein the engagement member extends distally from the driver head.

[0328] Example 66. An assembly according to any example herein, particularly any one of Examples 62 to 65, wherein the engagement portion is sized so that it does not contact an inner surface of the first actuation member.

[0329] Example 67. An assembly according to any example herein, particularly any one of examples 62 to 66, wherein the arm is movable between an extended position and a compressed position.

[0330] Example 68. An assembly according to any example herein, particularly Example 67, wherein the arm is offset radially outward from a longitudinal axis of the second actuation member.

[0331] Example 69. An assembly according to any example herein, particularly any one of Examples 62 to 68, wherein each arm includes an opening, and wherein a corresponding protrusion of the actuator is selectively disposed within the opening.

[0332] Example 70. An assembly according to any example herein, particularly any one of Examples 62 to 69, wherein rotation of the second actuation member in a second direction causes a corresponding rotation of the actuator to radially compress the prosthetic valve.

[0333] Example 71. An assembly according to any example herein, particularly any one of Examples 62 to 70, wherein the frame comprises one or more pairs of axially spaced first and second frame members, each actuator extending through a corresponding pair of the first and second frame members.

[0334] Example 72. An assembly according to any example herein, in particular Example 71, wherein each actuator includes a stopper axially disposed between corresponding pairs of the first and second frame members, the stopper being configured to selectively abut an inflow end portion of the second frame member.

[0335] Example 73. An assembly according to any example herein, specifically any one of Examples 71 to 72, wherein each first frame member includes a nut disposed at an outflow end portion of the first frame member, the nut including an internal threaded hole configured to engage with a corresponding actuator.

[0336] Example 74. A delivery device comprising:

[0337] handle;

[0338] one or more actuator assemblies extending from the handle, each actuator assembly comprising:

[0339] a first actuation member having a distal portion configured to abut an end portion of a prosthetic heart valve, the distal portion including a first support extension and a second support extension,

[0340] a second actuation member extending through the first actuation member and comprising: a driver head having an engagement member configured to engage with a corresponding engagement portion of an actuator of the prosthetic heart valve; and a gripper member including one or more arms configured to releasably couple the actuator; and

[0341] wherein rotation of the second actuation member in a first direction is configured to radially expand the prosthetic valve, and rotation of the second actuation member in a second direction is configured to radially compress the prosthetic valve.

[0342] Example 75. A delivery device according to any example herein, specifically Example 74, wherein the first support extension is configured to extend partially over a radially inner surface of the prosthetic valve, and the second support extension is configured to extend partially over a radially outer surface of the prosthetic valve to inhibit rotation of the frame of the prosthetic valve relative to the actuator assembly.

[0343] Example 76. A delivery device according to any example herein, particularly any one of Examples 74 to 75, wherein the cross-section of the engagement portion is a square with chamfered corners.

[0344] Example 77. The delivery device of any example herein, particularly Example 76, wherein the engagement member extends distally from the driver head.

[0345] Example 78. A delivery device according to any example herein, particularly any one of Examples 74 to 77, wherein the second actuation member is sized so that it does not contact an inner surface of the first actuation member.

[0346] Example 79. A delivery device according to any example herein, particularly any one of Examples 74 to 78, wherein the one or more arms comprises a plurality of arms.

[0347] Example 80. A delivery device according to any example herein, in particular Example 79, wherein the arm is movable between an extended position and a compressed position.

[0348] Example 81. A delivery device according to any example herein, in particular Example 80, wherein the arm is offset radially outward from a longitudinal axis of the second actuation member.

[0349] Example 82. A delivery device according to any example herein, particularly any one of Examples 74 to 81, wherein each arm comprises an opening configured to selectively couple to a corresponding protrusion of the actuator.

[0350] Example 83. A delivery device according to any example herein, particularly any one of Examples 74 to 82, wherein rotation of the second actuation member along the second direction is configured to cause corresponding rotation of the corresponding actuator to radially compress the prosthetic valve.

[0351] Example 84. A prosthetic heart valve comprising:

[0352] A radially expandable and compressible frame, the frame comprising:

[0353] a plurality of circumferentially spaced axially extending posts;

[0354] a plurality of circumferentially spaced pairs of axially extending frame members, wherein each pair of frame members comprises an axially extending proximal frame member and an axially extending distal frame member, the distal frame member being axially spaced from the proximal frame member to define a gap therebetween, wherein each pair of frame members is circumferentially positioned between two posts;

[0355] a plurality of connecting struts connecting the posts to the proximal frame members and the distal frame members, wherein each post is connected (i) to an adjacent distal frame member of a first adjacent pair of frame members by two connecting struts, (ii) to an adjacent side frame member of the first adjacent pair of frame members by two connecting struts, (iii) to an adjacent distal frame member of a second adjacent pair of frame members by two connecting struts, and (iv) to an adjacent side frame member of the second adjacent pair of frame members by two connecting struts, wherein each connecting strut has a concave curvature and a convex curvature separated by an inflection point;

[0356] a plurality of actuators extending through respective pairs of first and second frame members, wherein the actuators are configured to radially expand the frame from a radially compressed state to a radially expanded state; and

[0357] A valve structure is disposed within the frame and is configured to regulate unidirectional blood flow through the frame.

[0358] Example 85. A prosthetic heart valve according to any example herein, in particular Example 84, wherein the struts, the columns, and the proximal and distal frame members are arranged to form a plurality of hexagonal units and a plurality of rhombus units, wherein each rhombus unit is disposed within one of the hexagonal units.

[0359] Example 86. A prosthetic heart valve according to any example herein, in particular Example 85, wherein each rhombus-shaped unit is located at the center of a corresponding hexagonal unit.

[0360] Example 87. A prosthetic heart valve according to any example herein, particularly any one of Examples 85 to 86, wherein each hexagonal unit defines an inflow vertex of the frame and an outflow vertex of the frame.

[0361] Example 88. A prosthetic heart valve according to any example herein, particularly any one of Examples 85 to 87, wherein there are exactly six hexagonal cells and exactly six diamond cells.

[0362] Example 89. A prosthetic heart valve according to any example herein, particularly any one of Examples 85 to 88, wherein the hexagonal cells extend the entire length of the frame.

[0363] Example 90. A prosthetic heart valve according to any example herein, specifically any one of Examples 84 to 89, wherein the valve structure includes a plurality of leaflets, each leaflet including two commissure tabs located on opposite sides of the leaflet, wherein each commissure tab is paired with an adjacent commissure tab of an adjacent leaflet to form a commissure, wherein each commissure is fixed to an adjacent post.

[0364] Example 91. A prosthetic heart valve according to any example herein, in particular Example 90, wherein each post adjacent to a commissure comprises a slot, and a pair of commissure tabs of adjacent commissures extend through the slot.

[0365] Example 92. A prosthetic heart valve according to any example herein, particularly any one of Examples 84 to 91, wherein the plurality of actuators comprises a threaded rod having external threads.

[0366] Example 93. A prosthetic heart valve according to any example herein, in particular Example 92, wherein for each pair of proximal and distal frame members having an actuator extending therethrough, the proximal frame member has an unthreaded hole, the distal frame member has a hole with an internal thread, and the actuator extends through the unthreaded hole of the proximal frame member and the hole of the distal frame member, wherein the external threads of the actuator engage with the internal threads of the distal frame member.

[0367] Example 94. A prosthetic heart valve according to any example herein, in particular Example 93, wherein for each pair of proximal and distal frame members having an actuator extending therethrough, the distal frame member includes a cutout area and a nut disposed in the cutout area, wherein the nut defines the internal thread of the hole of the distal member.

[0368] Example 95. A prosthetic heart valve according to any example herein, particularly any one of Examples 84 to 94, wherein each post comprises a cantilevered extension extending toward an inflow end of the frame.

[0369] Example 96. According to any example herein, in particular the prosthetic heart valve described in Example 95, further comprising an inner skirt and / or an outer skirt, wherein the inner skirt and / or the outer skirt are mounted on the frame, wherein the inner skirt and / or the outer skirt are fixed to the extension portion with sutures.

[0370] Example 97. A prosthetic heart valve according to any example herein, particularly any one of Examples 95 to 96, wherein the cusp edge portion of the leaflet of the valve structure is secured to the extension portion with sutures.

[0371] Example 98. A prosthetic heart valve, comprising:

[0372] A radially expandable and compressible frame, the frame comprising:

[0373] a plurality of pairs of axially extending frame members, wherein each pair of frame members includes a first frame member and a second frame member, the second frame member being axially spaced from the first frame member, wherein the pairs of frame members are circumferentially spaced from one another about a circumference of the frame, wherein the first frame member of each pair includes a cutout region that receives a nut having internal threads;

[0374] a plurality of threaded rods extending through respective pairs of first and second frame members, wherein each threaded rod includes external threads that engage with internal threads of a corresponding nut, wherein rotation of the threaded rods in a first direction radially expands the frame from a radially compressed state to a radially expanded state;

[0375] A valve structure is disposed within the frame and is configured to regulate unidirectional blood flow through the frame.

[0376] Example 99. A prosthetic heart valve according to any example herein, in particular Example 98, wherein the frame further comprises a plurality of axially extending posts and a plurality of connecting struts, wherein each post is circumferentially disposed between a first pair and a second pair of frame members, and the connecting struts connect the posts to the paired frame members.

[0377] Example 100. A prosthetic heart valve according to any example herein, in particular Example 99, wherein each column (i) is connected to an adjacent first frame member of a first adjacent pair of frame members by two connecting struts, (ii) is connected to an adjacent second frame member of the first adjacent pair of frame members by two connecting struts, (iii) is connected to an adjacent first frame member of a second adjacent pair of frame members by two connecting struts, and (iv) is connected to an adjacent second frame member of the second adjacent pair of frame members by two connecting struts.

[0378] Example 101. A prosthetic heart valve according to any example herein, particularly any one of Examples 99 to 100, wherein each connecting strut has a concave curvature and a convex curvature separated by an inflection point.

[0379] Example 102. A prosthetic heart valve according to any example herein, specifically any one of Examples 99 to 101, wherein the struts, the columns, and the first and second frame members are arranged to form a plurality of hexagonal units and a plurality of rhombus units, wherein each rhombus unit is disposed within one of the hexagonal units.

[0380] Example 103. A prosthetic heart valve according to any example herein, in particular Example 102, wherein each rhombus-shaped unit is located at the center of a corresponding hexagonal unit.

[0381] Example 104. A prosthetic heart valve according to any example herein, particularly any one of Examples 102 to 103, wherein each hexagonal unit defines an inflow vertex of the frame and an outflow vertex of the frame.

[0382] Example 105. A prosthetic heart valve according to any example herein, particularly any one of Examples 102 to 104, wherein there are exactly six hexagonal cells and exactly six diamond cells.

[0383] Example 106. A prosthetic heart valve according to any example herein, particularly any one of Examples 102 to 105, wherein the hexagonal units extend the entire length of the frame.

[0384] Example 107. A prosthetic heart valve according to any example herein, specifically any one of Examples 98 to 106, wherein the valve structure includes a plurality of leaflets, each leaflet including two commissure tabs located on opposite sides of the leaflet, wherein each commissure tab is paired with an adjacent commissure tab of an adjacent leaflet to form a commissure, wherein each commissure is fixed to an adjacent post.

[0385] Example 108. The prosthetic heart valve of any example herein, particularly Example 107, wherein each post adjacent to a commissure comprises a slot, and a pair of commissure tabs of adjacent commissures extend through the slot.

[0386] Example 109. A delivery device comprising:

[0387] One or more actuator assemblies extending from the handle, each actuator assembly comprising:

[0388] Outer sleeve;

[0389] an actuation member extending through the outer sleeve and having a distal portion configured to releasably couple to an actuator of a prosthetic heart valve, the distal portion comprising:

[0390] a driver head including an engagement member extending distally from a body of the driver head, the engagement member being configured to extend into a corresponding recess in a head portion of the actuator, and

[0391] a gripper member comprising a plurality of arms configured to releasably couple to the head portion of the actuator, the plurality of arms each comprising a distal portion having teeth extending radially inwardly toward a longitudinal axis of the actuation member, and each arm having an arcuate cross-sectional shape;

[0392] wherein 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.

[0393] Example 110. The delivery device of any example herein, particularly Example 109, wherein the distal end of the outer sleeve comprises a first support extension and a second support extension.

[0394] Example 111. A delivery device according to any example herein, specifically Example 110, wherein the first support extension is configured to extend partially over a radially inner surface of the prosthetic valve, and the second support extension is configured to extend partially over a radially outer surface of the prosthetic valve to inhibit rotation of the frame of the prosthetic valve relative to the actuator assembly.

[0395] Example 112. A delivery device according to any example herein, particularly any one of Examples 109 to 111, wherein the plurality of arms are movable between an expanded position and a compressed position.

[0396] Example 113. A delivery device according to any example herein, particularly Example 112, wherein the plurality of arms are configured to be biased radially outward away from a longitudinal axis of the actuation member.

[0397] Example 114. A delivery device according to any example herein, particularly any one of Examples 109 to 113, wherein the cross-section of the engagement member is square.

[0398] Example 115. A delivery device according to any example herein, particularly any one of Examples 109 to 114, wherein the engagement member comprises one or more facets configured to engage with corresponding facets in corresponding recesses in the head portion of the actuator.

[0399] Example 116. A delivery device according to any example herein, particularly any one of Examples 109 to 115, wherein the driver head includes one or more protrusions extending radially outward from the driver head.

[0400] Example 117. A delivery device according to any example herein, particularly Example 116, wherein the one or more protrusions are disposed between adjacent arms when the plurality of arms are in a compressed position.

[0401] Example 118. A delivery device according to any example herein, particularly any one of Examples 116 to 117, wherein the protrusion comprises a rectangular prism shape with chamfered side edges.

[0402] Example 119. The delivery device of any example herein, particularly any one of Examples 116 to 118, wherein the one or more protrusions include four protrusions spaced apart from one another around the periphery of the driver head.

[0403] Example 120. A delivery device according to any example herein, particularly any one of Examples 109 to 119, wherein the holder member comprises an annular base member and the plurality of arms extend distally from the annular base member.

[0404] Example 121. A delivery device according to any example herein, particularly any one of Examples 109 to 120, wherein the plurality of arms and the outer sleeve form a collet.

[0405] Example 122. A delivery device according to any example herein, particularly any one of Examples 109 to 121, wherein each tooth comprises an angled proximal surface.

[0406] Example 123. A delivery device according to any example herein, particularly any one of Examples 109 to 122, wherein the distal portion of each arm flares radially outward such that the radial thickness of the distal portion is thicker than the radial thickness of the body of the arm.

[0407] Example 124. A delivery device according to any example herein, particularly any one of Examples 109 to 123, wherein the plurality of arms comprises four arms.

[0408] Example 125. A delivery device according to any example herein, particularly any one of Examples 109 to 124, wherein the distal portion of each arm has an increased circumferential width relative to the body of the arm.

[0409] Example 126. An assembly comprising:

[0410] A prosthetic heart valve, the prosthetic heart valve comprising:

[0411] a radially expandable and compressible frame having an inflow end portion and an outflow end portion, and

[0412] one or more actuators having a body and a head portion, the actuators being configured to radially expand the frame upon rotation of the one or more actuators, the head portion may include a central recess and a circumferentially extending recess; and

[0413] A delivery device, the delivery device comprising:

[0414] handle,

[0415] one or more actuator assemblies extending from the handle, each actuator assembly comprising an outer sleeve and an actuating member extending through the outer sleeve, the actuating member having a distal portion, the distal portion comprising:

[0416] a driver head including an engagement member extending distally from a body of the driver head, the engagement member extending into a central recess of a corresponding actuator, and

[0417] a gripper member comprising a plurality of arms configured to releasably couple to the head portion of the respective actuator, the plurality of arms each comprising a distal portion having teeth extending into a circumferential recess of the respective actuator; and

[0418] wherein 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.

[0419] Example 127. An assembly according to any example herein, particularly Example 126, wherein the cross-section of the central recess is square.

[0420] Example 128. A delivery device according to any example herein, particularly any one of Examples 126 to 127, wherein the cross-section of the engagement member is square.

[0421] Example 129. An assembly according to any example herein, particularly any one of Examples 126 to 128, wherein the joining member includes one or more facets configured to join with corresponding facets in the central recess.

[0422] Example 130. An assembly according to any example herein, particularly any one of Examples 126 to 129, wherein the circumferential recess extends circumferentially around the head portion and includes an angled proximal surface.

[0423] Example 131. An assembly according to any example herein, particularly any of Examples 126 to 130, wherein each tooth includes an angled proximal surface corresponding to the angled proximal surface of the circumferential recess.

[0424] Example 132. An assembly according to any example herein, particularly any one of Examples 126 to 131, wherein the distal end of the outer sleeve includes a first support extension and a second support extension.

[0425] Example 133. An assembly according to any example herein, specifically Example 132, wherein the first support extension is configured to extend partially over a radially inner surface of the prosthetic valve, and the second support extension is configured to extend partially over a radially outer surface of the prosthetic valve to inhibit rotation of the frame of the prosthetic valve relative to the actuator assembly.

[0426] Example 134. An assembly according to any example herein, particularly any one of Examples 126 to 133, wherein the plurality of arms are movable between an extended position and a compressed position.

[0427] Example 135. An assembly according to any example herein, in particular Example 134, wherein the plurality of arms are configured to be biased radially outward away from a longitudinal axis of the actuation member.

[0428] Example 136. The assembly of any example herein, particularly any one of Examples 126 to 135, wherein the driver head includes one or more protrusions extending radially outward from the driver head.

[0429] Example 137. An assembly according to any example herein, particularly Example 136, wherein the one or more protrusions are disposed between adjacent arms when the plurality of arms are in a compressed position.

[0430] Example 138. An assembly according to any example herein, particularly any one of examples 136 to 137, wherein the protrusion comprises a rectangular prism shape with chamfered side edges.

[0431] 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 perimeter of the driver head.

[0432] Example 140. An assembly according to any example herein, particularly any one of Examples 126 to 139, wherein the clamp member includes an annular base member and the plurality of arms extend distally from the annular base member.

[0433] Example 141. An assembly according to any example herein, particularly any one of Examples 126 to 140, wherein the plurality of arms and the outer sleeve form a collet.

[0434] Example 142. An assembly according to any example herein, particularly any one of Examples 126 to 141, wherein the distal portion of each arm flares radially outwardly such that the radial thickness of the distal portion is thicker than the radial thickness of the body of the arm.

[0435] Example 143. An assembly according to any example herein, particularly any one of Examples 126 to 142, wherein the plurality of arms includes four arms.

[0436] Example 144. An assembly according to any example herein, particularly any one of Examples 126 to 143, wherein the distal portion of each arm has an increased circumferential width relative to the body of the arm.

[0437] Example 145. An assembly according to any example herein, particularly any one of Examples 126 to 145, wherein the frame comprises a plurality of pairs of axially extending frame members, wherein each pair of frame members comprises a first frame member and a second frame member, the second frame member being axially spaced apart from the first frame member, and wherein the one or more actuators each extend through a corresponding pair of frame members.

[0438] Example 146. An assembly according to any example herein, particularly Example 145, wherein the pair of frame members are circumferentially spaced from each other around the circumference of the frame.

[0439] Example 147. A method comprising:

[0440] axially advancing an actuation member of an actuator assembly of a delivery device 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;

[0441] continuing to advance the actuation member such that teeth extending radially inwardly from the plurality of arms are seated within the circumferential recess and such that an engagement member extending distally from the actuation member is seated within the central recess; and

[0442] Advancing an outer sleeve of the actuator assembly over the actuation member radially compresses the plurality of arms, thereby retaining the teeth within the circumferential recesses and coupling the actuator assembly to the prosthetic valve.

[0443] Example 148. A delivery device comprising:

[0444] One or more actuator assemblies extending from the handle, each actuator assembly comprising:

[0445] Outer sleeve;

[0446] an actuation member extending through the outer sleeve and having a distal portion configured to releasably couple to an actuator of a prosthetic heart valve, the distal portion comprising:

[0447] a driver head comprising an engagement member extending distally from a body of the driver head, the engagement member being configured to extend into a corresponding recess in a head portion of the actuator, the engagement member comprising one or more facets configured to engage with corresponding facets in the corresponding recess, and

[0448] a gripper member comprising a plurality of arms configured to releasably couple to the head portion of the actuator, the plurality of arms each comprising a distal portion having teeth extending radially inwardly toward a longitudinal axis of the actuation member, the distal portion of each arm having an increased circumferential width relative to a body of the arm;

[0449] wherein rotation of the actuation member in a first direction causes the prosthetic valve to radially expand, and rotation of the actuation member in a second direction causes the prosthetic valve to radially compress.

[0450] Example 148. An implantable prosthetic device comprising:

[0451] A radially expandable and compressible frame having an inflow end portion and an outflow end portion, the frame comprising:

[0452] A plurality of columns, one or more of which are configured as an actuation mechanism, the actuation mechanism comprising:

[0453] a first frame member having a first inner hole,

[0454] a second frame member having a second internal bore, the first frame member and the second frame member being axially spaced from each other, and

[0455] an actuator having an externally threaded surface and extending through the first and second inner bores, the actuator comprising a body and a head portion, the head portion comprising a circumferential recess; and

[0456] a plurality of struts coupling adjacent struts to one another; and

[0457] Wherein rotation of the actuator in a first direction causes axial movement of the first frame member and the second frame member toward each other to radially expand the prosthetic device.

[0458] Example 149. An implantable prosthetic device according to any example herein, particularly Example 148, wherein the circumferential recess comprises an angled proximal surface.

[0459] Example 150. An implantable prosthetic device according to any example herein, particularly any one of Examples 148 to 149, wherein the head portion further includes a central recess.

[0460] Example 151. An implantable prosthetic device according to any example herein, particularly Example 150, wherein the central recess comprises one or more facets configured to engage with corresponding facets on an actuation assembly of a delivery apparatus.

[0461] Example 152. An implantable prosthetic device according to any example herein, particularly any one of Examples 150 to 151, wherein the cross-section of the central recess is square.

[0462] Example 153. A delivery device comprising:

[0463] One or more actuator assemblies extending from the handle, each actuator assembly comprising:

[0464] an outer sleeve including a first support extension and a second support extension extending from a distal portion thereof;

[0465] 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:

[0466] a driver head including an engagement element configured to engage with a corresponding engagement element in a head portion of the actuator, and

[0467] a holder member comprising a plurality of arms configured to releasably couple to the head portion of the actuator, the plurality of arms each comprising a first proximal portion and a second distal portion, the distal portion having a circumferential width greater than a circumferential width of the proximal portion, and each arm having an arcuate cross-sectional shape;

[0468] wherein 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.

[0469] Example 154. The delivery device of any example herein, particularly Example 153, wherein the driver head engagement element comprises a protrusion extending distally from a body of the driver head, the protrusion having a square cross-section.

[0470] Example 155. A delivery device according to any example herein, in particular Example 154, wherein the engagement element of the head portion of the actuator includes a corresponding recess, and wherein the drive head engagement element includes one or more small facets, and the one or more small facets are configured to engage with corresponding small facets in the corresponding recess.

[0471] Example 156. A delivery device according to any example herein, particularly any one of Examples 153 to 155, wherein the drive head includes one or more protrusions extending radially outward from the drive head such that when the multiple arms are in a compressed position, the one or more protrusions are positioned between adjacent arms.

[0472] Example 157. A delivery device according to any example herein, in particular Example 156, wherein the protrusion comprises a rectangular prism shape with chamfered side edges.

[0473] Example 158. A delivery device according to any example herein, particularly any one of Examples 153 to 157, wherein the plurality of arms and the outer sleeve together form a collet.

[0474] Example 159. A delivery device according to any example herein, particularly any one of Examples 153 to 158, wherein each arm comprises a tooth extending radially inwardly toward a longitudinal axis of the actuation member, and wherein each tooth comprises an angled proximal surface.

[0475] Example 160. A delivery device according to any example herein, particularly any one of Examples 153 to 159, wherein the distal portion of each arm flares radially outward such that the radial thickness of the distal portion is thicker than the radial thickness of the body of the arm.

[0476] Example 161. A delivery device according to any example herein, particularly Example 153, wherein the driver head engagement element comprises a recess having a semicircular cross-section.

[0477] Example 162. A delivery device according to any example herein, in particular Example 161, wherein the engagement element of the head portion of the actuator includes a corresponding Ω-shaped protrusion, and the corresponding Ω-shaped protrusion is configured to be at least partially disposed within the recess.

[0478] Example 163. A delivery device according to any example herein, particularly any one of Examples 161 to 162, wherein the thickness of each arm from the proximal portion to the distal portion is uniform.

[0479] Example 164. A delivery device according to any example herein, particularly any one of Examples 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.

[0480] Example 165. A delivery device according to any example 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.

[0481] Example 166. A delivery device comprising:

[0482] One or more actuator assemblies extending from the handle, each actuator assembly comprising:

[0483] Outer sleeve;

[0484] an actuation member extending through the outer sleeve and having a distal portion configured to releasably couple to an actuator of a prosthetic heart valve, the distal portion comprising:

[0485] a driver head including an engagement member extending distally from a body of the driver head, the engagement member being configured to extend into a corresponding recess in a head portion of the actuator, the driver head including one or more protrusions extending radially from the driver head, and

[0486] a gripper member comprising a plurality of arms configured to releasably couple to the head portion of the actuator, the plurality of arms each comprising a distal portion having teeth extending radially inwardly toward a longitudinal axis of the actuation member, and each arm having an arcuate cross-sectional shape;

[0487] wherein 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.

[0488] Example 167. A delivery device according to any example herein, specifically Example 166, wherein the distal end of the outer sleeve includes a first support extension and a second support extension, and wherein the first support extension is configured to extend partially over a radial inner surface of the prosthetic valve and the second support extension is configured to extend partially over a radial outer surface of the prosthetic valve to inhibit rotation of the prosthetic valve relative to the actuator assembly.

[0489] Example 168. A delivery device according to any example herein, particularly any one of Examples 166 to 167, wherein the one or more protrusions are disposed between adjacent arms when the plurality of arms are in a compressed position.

[0490] Example 169. A delivery device comprising:

[0491] One or more actuator assemblies extending from the handle, each actuator assembly comprising:

[0492] Outer sleeve;

[0493] an actuation member extending through the outer sleeve and having a distal portion configured to releasably couple to an actuator of a prosthetic heart valve, the distal portion comprising:

[0494] a driver head including an engagement recess extending proximally into a body of the driver head, the engagement recess being 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, and

[0495] a gripper member comprising a plurality of arms configured to releasably couple to the head portion of the actuator, the plurality of arms each having an arcuate cross-sectional shape, each pair of adjacent arms of the plurality of arms defining an Ω-shaped recess therebetween;

[0496] wherein 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.

[0497] Example 170. According to any example herein, in particular the delivery device of Example 169, wherein the engaging member of the head portion of the actuator includes an Ω-shaped protrusion, and the Ω-shaped protrusion is configured to be at least partially disposed within the engaging recess and one or more of the Ω-shaped recesses of the clamping member.

[0498] Example 171. A delivery device according to any example herein, particularly any one of Examples 169 to 170, wherein the thickness of each arm from the proximal portion to the distal portion is uniform.

[0499] Example 172. A delivery device according to any example herein, specifically any one of Examples 169 to 171, wherein each of the plurality of arms has a neck portion and a distal portion, the neck portion having a first circumferential width, the distal portion having a second circumferential width greater than the first circumferential width.

[0500] In view of the many possible examples to which the principles of the present disclosure may be applied, it should be appreciated that the examples shown are only preferred examples and should not be considered as limiting the scope. Instead, the scope is defined by the following claims. Therefore, protection is sought for all that falls within the scope and spirit of these claims.

Claims

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; and 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 with a corresponding engagement element in a head portion of the actuator, and a holder member comprising a plurality of arms configured to releasably couple to the head portion of the actuator, the plurality of arms each comprising a first proximal portion and a second distal portion, the distal portion having a circumferential width greater than a circumferential width of the proximal portion, and each arm having an arcuate cross-sectional shape; wherein 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.

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 being square in cross-section.

3. A delivery device according to claim 2, wherein the engagement element of the head portion of the actuator includes a corresponding recess, and wherein the driver head engagement element includes one or more small facets, and the one or more small facets are configured to engage with corresponding small facets in the corresponding recess.

4. The delivery device of any one of claims 1 to 3, wherein the driver head comprises one or more protrusions extending radially outward from the driver head such that when the plurality of arms are in a compressed position, the one or more protrusions are disposed between adjacent arms.

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. The delivery device of any one of claims 1 to 6, wherein each arm comprises a tooth extending radially inwardly toward a longitudinal axis of the actuation member, and wherein each tooth comprises an angled proximal surface.

8. The delivery device of any one of claims 1 to 7, wherein the distal portion of each arm flares radially outwardly such that the radial thickness of the distal portion is thicker than the radial thickness of the body of the arm.

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

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

11. The delivery device of any one of claims 9 to 10, wherein the thickness of each arm from the proximal portion to the distal portion is uniform.

12. The delivery device of any one of claims 1 to 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 the circumference of the outer sleeve.

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

15. A delivery device according to claim 14, wherein the distal end of the outer sleeve includes a first support extension and a second support extension, and wherein the first support extension is configured to extend partially over the radial inner surface of the prosthetic valve and the second support extension is configured to extend partially over the radial outer surface of the prosthetic valve to inhibit rotation of the prosthetic valve relative to the actuator assembly.

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

17. A delivery device comprising: One or more actuator assemblies extending from the handle, each actuator assembly comprising: an outer sleeve; and an actuation member extending through the outer sleeve and having a distal portion configured to releasably couple to an actuator of a prosthetic heart valve, the distal portion comprising: a driver head including an engagement recess extending proximally into a body of the driver head, the engagement recess being 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, and a gripper member comprising a plurality of arms configured to releasably couple to the head portion of the actuator, the plurality of arms each having an arcuate cross-sectional shape, each pair of adjacent arms of the plurality of arms defining an Ω-shaped recess therebetween; wherein 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.

18. A delivery device according to claim 17, wherein the engagement member of the head portion of the actuator includes an Ω-shaped protrusion, which is configured to be at least partially disposed within the engagement recess and one or more of the Ω-shaped recesses of the clamp member.

19. The delivery device of any one of claims 17 to 18, wherein the thickness of each arm from the proximal portion to the distal portion is uniform.

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 portion having a second circumferential width greater than the first circumferential width.

Images