Delivery devices for prosthetic devices

Abstract

The delivery device for a prosthetic valve includes a handle body and a shaft displacement and shaft adjustment mechanism coupled to the handle body. The shaft displacement mechanism is configured to axially displace the shaft relative to the handle body. The adjustment mechanism is configured to adjust the curvature of the shaft and includes a pull wire coupled to the distal end of the shaft. A first knob is operably coupled to the shaft displacement mechanism and rotatable relative to the handle body, such that rotating the first knob relative to the handle body simultaneously axially displaces the shaft and the pull wire relative to the handle body. A second knob is operably coupled to the shaft adjustment mechanism and rotatable relative to the handle body, such that rotating the second knob relative to the handle body adjusts the curvature of the shaft independently of the axial displacement of the shaft.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Patent Application No. 63 / 404,496, filed September 7, 2022, the contents of which are incorporated herein by reference in their entirety.

[0002] FIELD OF THE DISCLOSURE The present disclosure relates to devices and methods for delivering, expanding, and implanting implantable radially expandable prosthetic devices, such as prosthetic heart valves, stents, and the like. [Background technology]

[0003] The human heart can suffer from a variety of valvular diseases. These valvular diseases can cause serious cardiac dysfunction, ultimately necessitating repair of the native valve or replacement of the native valve with a prosthetic valve. Numerous repair devices (e.g., stents) and prosthetic valves are known, as are numerous methods for implanting such devices and valves into humans. Percutaneous and minimally invasive surgical approaches are used in various procedures to deliver prosthetic medical devices to locations within the body that are not easily accessible by surgery or where non-surgical access is desirable. In one specific example, a prosthetic heart valve can be crimped onto the distal end of a delivery device and advanced through the patient's vascular system (e.g., through the femoral artery and aorta) to reach the implantation site within the heart. The prosthetic heart valve is then expanded to its functional size, for example, by inflating a balloon on which the prosthetic valve is mounted and activating a mechanical actuator that applies an expansive force to the prosthetic heart valve, or by deploying the prosthetic heart valve from a sheath of a delivery device so that the prosthetic heart valve can self-expand to its functional size. Summary of the Invention

[0004] Described herein are prosthetic heart valves, delivery devices, and methods for implanting the prosthetic heart valves. The disclosed prosthetic heart valves, delivery devices, and methods can provide, for example, manipulation of the radius of curvature of the shaft of the delivery device independent of axial displacement of the shaft relative to other components of the delivery device and / or relative to the prosthesis. Thus, the devices and methods disclosed herein can address, among other things, one or more deficiencies associated with typical prosthetic heart valves and their delivery devices.

[0005] A delivery device for a prosthetic implant may include a handle and a shaft coupled to the handle.

[0006] In some embodiments, the delivery device may include a shaft displacement mechanism coupled to the handle, and a first knob operably coupled to the shaft displacement mechanism and rotatable relative to the handle.

[0007] In some embodiments, the delivery device may include a shaft adjustment mechanism coupled to the handle and a second knob operably coupled to the shaft adjustment mechanism and rotatable relative to the handle.

[0008] In some embodiments, the shaft adjustment mechanism comprises a pull wire coupled to the distal end of the shaft.

[0009] In some examples, the shaft displacement mechanism may be configured such that rotating the first knob relative to the handle simultaneously axially displaces the shaft and pull wire relative to the handle.

[0010] In some examples, the shaft adjustment mechanism may be configured such that rotating the second knob relative to the handle adjusts the curvature of the shaft independently of the axial displacement of the shaft.

[0011] In some embodiments, the shaft adjustment mechanism may include a rotatable adjustment barrel having a bore with a threaded inner surface, and an adjustment nut coupled to the pull wire and disposed within the bore.

[0012] In some examples, the adjustment nut may have a threaded outer surface coupled to a threaded inner surface of the adjustment barrel, and the adjustment nut may be configured to translate axially relative to the adjustment barrel in response to rotation of the adjustment barrel.

[0013] In some examples, the adjustment nut can have an attachment member extending radially from the body of the adjustment nut, with the proximal end of the pull wire wrapped around the attachment member.

[0014] In some embodiments, the delivery device may include a connector shaft coupled to an adjustment mechanism and a shaft displacement mechanism.

[0015] In some embodiments, the adjustment nut may be circumferentially disposed around the connector shaft and may be axially movable relative to the connector shaft.

[0016] In some embodiments, the delivery device may be configured with a gear system operatively connecting the shaft adjustment mechanism and the second knob.

[0017] In some embodiments, the delivery device may be configured with a gear system operatively connecting the shaft displacement mechanism and the first knob.

[0018] In some examples, the delivery device may be configured with a rotatable indicator coupled to the shaft adjustment mechanism and configured to indicate the curvature of the shaft upon rotation of the second knob.

[0019] In some embodiments, the shaft displacement mechanism may comprise a displacement nut coupled to the shaft.

[0020] In some examples, the displacement nut may be configured to thread onto the first knob such that rotation of the first knob relative to the handle causes axial displacement of the displacement nut and shaft relative to the handle.

[0021] In some examples, a displacement nut may be threaded onto one or more threaded rods, each of which is coupled to a gear that meshes with an inner surface of the first knob, such that rotation of the first knob relative to the handle results in axial displacement of the displacement nut and the shaft relative to the handle.

[0022] In some examples, the first knob may be configured to be proximal to the second knob and the displacement nut such that the first knob and the second knob are axially separated on the handle of the delivery device.

[0023] In some embodiments, the delivery device includes one or more of the components described in Examples 1-95 and 103-106 below.

[0024] A prosthetic heart valve for use with the delivery devices disclosed in the present disclosure may include a frame and a valve structure coupled to the frame. In addition to these components, the prosthetic heart valve may further include one or more of the components disclosed herein.

[0025] A method of using a delivery device for delivery of a prosthetic implant can include adjusting the curvature of a delivery shaft that holds the prosthetic implant relative to a longitudinal axis of a handle coupled to the delivery shaft.

[0026] In some examples, the method may include moving a delivery shaft relative to the prosthetic implant, wherein the curvature may be maintained during the displacement.

[0027] In some embodiments, adjusting the curvature may include rotating a first knob relative to the handle.

[0028] In some embodiments, displacing the delivery shaft relative to the prosthetic implant can include rotating a second knob relative to the handle.

[0029] In some embodiments, the method includes one or more of the features described in Examples 96-102 below.

[0030] One or more of the methods described above can be performed on a live animal or on a simulation, such as a cadaver, a cadaver heart, an anthropomorphic ghost, a simulator (e.g., a simulated body part, heart, tissue, etc.), etc.

[0031] In some embodiments, a delivery device for a prosthetic valve comprises a handle body; a shaft displacement mechanism coupled to the handle body, the shaft displacement mechanism configured to axially displace a shaft relative to the handle body; a shaft adjustment mechanism coupled to the handle body, the shaft adjustment mechanism configured to adjust a curvature of the shaft, the shaft adjustment mechanism comprising a pull wire coupled to a distal end of the shaft; a first knob operably coupled to the shaft displacement mechanism and rotatable relative to the handle body, where rotating the first knob relative to the handle body simultaneously axially displaces the shaft and the pull wire relative to the handle body; and a second knob operably coupled to the shaft adjustment mechanism and rotatable relative to the handle body, where rotating the second knob relative to the handle body adjusts the curvature of the shaft independently of the axial displacement of the shaft.

[0032] In some embodiments, a handle for a delivery device for a prosthetic valve comprises: a handle body; a shaft displacement mechanism coupled to the handle body, the shaft displacement mechanism configured to axially displace a shaft relative to the handle body; a shaft adjustment mechanism coupled to the handle body, the shaft adjustment mechanism configured to adjust a curvature of the shaft, the shaft adjustment mechanism comprising a pull wire coupled to a distal end of the shaft; a first knob operably coupled to the shaft displacement mechanism and rotatable relative to the handle body, wherein rotating the first knob relative to the handle body simultaneously axially displaces the shaft and the pull wire relative to the handle body; and a second knob operably coupled to the shaft adjustment mechanism and rotatable relative to the handle body, wherein rotating the second knob relative to the handle body adjusts the curvature of the shaft independently of the axial displacement of the shaft.

[0033] In some examples, a delivery device for a prosthetic valve comprises: a delivery shaft; at least one expansion mechanism disposed within the delivery shaft; a displacement nut coupled to a proximal end portion of the delivery shaft, the displacement nut configured to axially displace the delivery shaft relative to the expansion mechanism; a shaft adjustment mechanism comprising a pull wire coupled to a distal end of the delivery shaft, the shaft adjustment mechanism configured to adjust a curvature of the delivery shaft; a connector shaft coupled to the displacement nut and the shaft adjustment mechanism; a first knob operably coupled to the displacement nut and rotatable relative to the expansion mechanism, wherein rotating the first knob relative to the expansion mechanism simultaneously axially displaces the displacement nut, the delivery shaft, the pull wire, and the connector shaft relative to the expansion mechanism; and a second knob operably coupled to the shaft adjustment mechanism and rotatable relative to the expansion mechanism, wherein rotating the second knob relative to the expansion mechanism adjusts tension in the pull wire independently of axial displacement of the delivery shaft.

[0034] In some embodiments, a delivery device for a prosthetic valve comprises a delivery shaft, at least one expansion mechanism disposed within the delivery shaft, a displacement member coupled to a proximal end portion of the delivery shaft, the displacement member configured to axially displace the delivery shaft relative to the expansion mechanism, a pull wire coupled to a distal end of the delivery shaft, the pull wire configured to adjust a curvature of the delivery shaft, an adjustment nut coupled to the pull wire, the adjustment nut having a threaded outer surface, and a rotatable adjustment barrel having a threaded inner surface coupled to the threaded outer surface of the adjustment nut, wherein rotation of the adjustment barrel relative to the expansion member results in axial displacement of the adjustment nut relative to the adjustment barrel.

[0035] In some embodiments, a method of implanting a prosthetic implant includes adjusting a curvature of a delivery shaft holding the prosthetic implant relative to a longitudinal axis of a handle coupled to the delivery shaft, and displacing the delivery shaft relative to the prosthetic implant, wherein the curvature is maintained during the displacement.

[0036] The various innovations in this disclosure can be used in combination or separately. This Summary is provided to introduce in a simplified form a selection of various concepts that are further described in the Detailed Description below. This Summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. These and other objects, features, and advantages of the present disclosure will become more apparent from the following Detailed Description, from the claims, and from the accompanying drawings. [Brief explanation of the drawings]

[0037] [Figure 1A] FIG. 1A is a perspective view of one embodiment of a prosthetic valve including a frame and multiple leaflets attached to the frame. [Figure 1B] FIG. 1B is a perspective view of the prosthetic valve of FIG. 1A having an outer skirt disposed around the frame. [Figure 2A] FIG. 2A is a perspective view of a frame for the prosthetic valve of FIG. 1A. [Figure 2B] FIG. 2B is a front view of the frame shown in FIG. 2A. [Figure 3] FIG. 3 is a side view of a delivery device for a prosthetic device, such as a prosthetic valve, according to one embodiment. [Figure 4] FIG. 4 is a perspective view of a portion of the actuator of the prosthetic device of FIGS. 1-2 and an actuator assembly of a delivery device, according to one embodiment. [Figure 5] FIG. 5 is a perspective view of the actuator and actuator assembly of FIG. 4, with the actuator assembly physically coupled to the actuator. [Figure 6] FIG. 6 is a side view of a delivery device for a prosthetic device, such as a prosthetic valve, according to one embodiment. [Figure 7] FIG. 8 is a partial cross-sectional view of the delivery device of FIG. 7. [Figure 8] 8 is a perspective view of the adjustment member and connector shaft of the delivery device of FIG. 6. FIG. [Figure 9] FIG. 9 is a detailed cross-sectional view of the delivery device of FIG. [Figure 10] FIG. 10 is a cross-sectional view of the delivery device of FIG. 6 taken along section 10-10 (FIG. 7). [Figure 11] 11 is a cross-sectional view of the adjustment lead member engaged with the gear of the delivery device of FIG. 6. FIG. [Figure 12] 12 is a cross-sectional view of the distal end of the handle of the delivery device of FIG. 6. FIG. [Figure 13] 13 is a cross-sectional view of the geared knob of the delivery device of FIG. 6. FIG. [Figure 14A] 14A is a cross-sectional view of the delivery device of FIG. 6 with the displacement mechanism in a first position. [Figure 14B] 14B is a cross-sectional view of the delivery device of FIG. 6 with the displacement mechanism in a second position. [Figure 15A] 15A is a cross-sectional view of the distal end of the delivery device of FIG. 6 positioned within the heart, showing the displacement mechanism in the first position of FIG. 14A. [Figure 15B] 15B is a cross-sectional view of the distal end of the delivery device of FIG. 6 positioned within the heart, showing the displacement mechanism in the second position of FIG. 14B. [Figure 16] 16 is a cross-sectional view of the delivery device of FIG. 6 with the displacement mechanism in a third position and the adjustment mechanism in a first position. [Figure 17] 17 is a cross-sectional view of the delivery device of FIG. 6 with the displacement mechanism in a third position and the adjustment mechanism in a second position. [Figure 18] 18 is a cross-sectional view of the distal end of the handle of the delivery device of FIG. 6, with the end cap omitted for purposes of illustration. [Figure 19] 19 is a perspective view of the distal end of the handle of the delivery device of FIG. 18. FIG. [Figure 20] 20 is a front view of the distal end of the handle of the delivery device of FIG. 18. FIG. [Figure 21] 21 shows a side view of the distal end of the handle of the delivery device of FIG. 6. FIG. [Figure 22] FIG. 22 is a perspective view of a delivery device for a prosthetic device, such as a prosthetic valve, according to another embodiment. [Figure 23] 23 is a perspective view of the delivery device of FIG. 22, omitting the housing of the delivery device. [Figure 24] 24 is a cross-sectional view of the delivery device of FIG. 22. DETAILED DESCRIPTION OF THE INVENTION

[0038] Detailed Description Basic premise For purposes of description, certain aspects, advantages, and novel configurations of examples of the disclosure are described in this disclosure. The disclosed methods, apparatus, and systems should not be construed as limiting in any way. Instead, the disclosure covers all novel and non-obvious configurations and aspects of the various disclosed examples, alone, in various combinations with each other, and in various subcombinations with each other. The methods, apparatus, and systems are not limited to any particular aspect, configuration, or combination thereof, nor do the disclosed embodiments require that any one or more particular advantages be present or problems be solved.

[0039] Although operations in some disclosed examples are described in a particular sequential order for convenience of presentation, it should be understood that aspects of the description encompass reordering unless a particular order is required by specific language set forth below. For example, operations described sequentially may, in some cases, be reordered or performed simultaneously. Moreover, for simplicity, the accompanying drawings may not show various ways in which the disclosed methods can be used in conjunction with other methods. Additionally, the description sometimes uses terms such as "provide" or "achieve" to describe the disclosed methods. These terms are high-level abstractions of the actual actions that are performed. The actual operations corresponding to these terms may vary depending on the particular implementation and are readily discernible by those skilled in the art.

[0040] As used in this application and in the claims, the singular forms "a," "an," and "the" include the plural forms unless the context clearly dictates otherwise. Additionally, the term "includes" means "comprises." Furthermore, the term "coupled" generally means to physically, mechanically, chemically, magnetically, and / or electrically join or link, and does not exclude the presence of intervening elements between coupled or associated members, unless specific language to the contrary exists.

[0041] As used in this disclosure, the term "proximal" refers to a position, orientation, or portion of a device that is closer to the user and farther away from the implantation site. As used in this disclosure, the term "distal" refers to a position, orientation, or portion of a device that is farther away from the user and closer to the implantation site. Thus, for example, proximal movement of a device is movement of the device away from the implantation site and toward the user (e.g., out of the patient's body), while distal movement of a device is movement of the device away from the user and toward the implantation site (e.g., into the patient's body). The terms "longitudinal" and "axial," unless expressly defined otherwise, refer to axes extending in the proximal and distal directions.

[0042] Overview of the disclosed technology The prosthetic valves disclosed in the present disclosure can be radially compressible and radially expandable between a radially compressed state and a radially expanded state. Thus, the prosthetic valve can be crimped onto or retained by an implant delivery device in a radially compressed state during delivery, and then expanded to a radially expanded state after the prosthetic valve reaches the implantation site. It is understood that the prosthetic valves disclosed in the present disclosure can be used with a variety of implant delivery devices and can be implanted via a variety of delivery procedures, examples of which are described in more detail below.

[0043] This disclosure describes examples of steerable delivery devices (sometimes referred to as steerable catheters) that can be used to navigate a subject's vasculature to deliver implantable, expandable medical devices (e.g., prosthetic heart valves), tools, medications, or other therapies to locations within the subject's body. Examples of procedures for which steerable catheters are useful include neurological, urological, reproductive, fertility (e.g., in vitro insemination, artificial insemination), laparoscopic, arthroscopic, transesophageal, transvaginal, transvascular, transrectal, and procedures involving access to any body canal or cavity. Specific examples include placing implants, including stents, grafts, embolic coils, etc.; positioning imaging devices and / or components thereof, including ultrasound transducers; and positioning energy sources, for example, to perform lithotripsy, RF sources, ultrasound emitters, electromagnetic sources, laser sources, thermal sources, etc.

[0044] The delivery device described herein may include a mechanism for adjusting (e.g., controlling, directing, bending, etc.) the distal end portion of a shaft that holds an implantable, expandable medical device (e.g., a prosthetic heart valve). The delivery device may also include a mechanism for axially displacing (e.g., advancing, retracting, etc.) the shaft relative to the medical device to position the medical device from the shaft at the implantation site. The shaft displacement mechanism and shaft adjustment mechanism can operate independently of each other, thus allowing for greater manipulation of the distal end portion of the shaft. For example, the displacement mechanism may be utilized to retract the shaft to deploy the medical device without affecting the curvature of the shaft during deployment. Furthermore, the control mechanism may be utilized to bend the shaft without affecting the axial position of the shaft relative to the handle of the delivery device. The delivery device described herein may also include a mechanism that indicates the amount of shaft adjustment (e.g., radius of curvature, etc.) based on operation of the adjustment mechanism.

[0045] 1A-2B illustrate an exemplary medical device (e.g., a prosthetic heart valve) that can be advanced through a patient's vasculature, for example, to a native heart valve, by a delivery device such as the delivery device shown in FIG. 3 or the delivery device shown in FIG. 6. Further details of a shaft displacement mechanism and a shaft adjustment mechanism for the delivery device are shown in FIGS. 7-17. An indicator mechanism for the delivery device is shown in FIGS. 18-21. Another exemplary delivery device according to the present disclosure is shown in FIGS. 22-24.

[0046] Examples of the disclosed technology 1A-2B illustrate a prosthetic valve 100 according to one embodiment. The prosthetic valve disclosed in this disclosure is adapted to be implanted in the native aortic valve annulus, but in some embodiments, may be adapted to be implanted in other native valve annulus of the heart (such as the pulmonary, mitral, and tricuspid valves). The disclosed prosthetic valves can also be implanted within blood vessels communicating with the heart, including the pulmonary artery (to replace the function of a diseased pulmonary valve), the superior vena cava, or the inferior vena cava (to replace the function of a diseased tricuspid valve), or various other veins, arteries, and blood vessels of a patient. The disclosed prosthetic valves can also be implanted within a previously implanted prosthetic valve (which may be a prosthetic surgical valve or a prosthetic transcatheter heart valve) in a valve-in-valve procedure.

[0047] In some examples, the disclosed prosthetic valves can be implanted within a docking device or anchoring device that is implanted within a native heart valve or blood vessel. For example, in one example, the disclosed prosthetic valves can be implanted within a docking device implanted within the pulmonary artery to replace the function of a diseased pulmonary valve, as disclosed in U.S. Publication No. 2017 / 0231756, which is incorporated herein by reference. In some examples, the disclosed prosthetic valves can be implanted within a docking device implanted within the native mitral valve or at the mitral valve, as disclosed in PCT Publication No. WO2020 / 247907, which is incorporated herein by reference. In some examples, the disclosed prosthetic valves can be implanted within a docking device implanted within the superior or inferior vena cava to replace the function of a diseased tricuspid valve, as disclosed in U.S. Publication No. 2019 / 0000615, which is incorporated herein by reference.

[0048] 1A-2B show an example of a prosthetic valve 100 (sometimes referred to in this disclosure as a "prosthetic heart valve 100") having a frame 102. FIGS. 2A-2B show the frame 102 alone, while FIGS. 1A-1B show the frame 102 with a valvular structure 150 (which may include valve leaflets 158, as described further below) within and attached to the annular frame 102. FIG. 1B also shows an optional skirt assembly comprising an outer skirt 103. While only one side of the frame 102 is shown in FIG. 2B, it should be understood that the frame 102 forms an annular structure, as shown in FIGS. 1A-2A, with the opposite side substantially identical to the portion shown in FIG. 1B.

[0049] As shown in FIGS. 1A and 1B , the valvular structure 150 is coupled to and supported within the frame 102. The valvular structure 150 is configured to regulate blood flow through the prosthetic valve 100 from the inflow end 134 to the outflow end 136. The valvular structure 150 may include a leaflet assembly including one or more leaflets 158 made, for example, of a flexible material. The leaflets 158 may be made, in whole or in part, from biological materials, biocompatible synthetic materials, or other such materials. Suitable biological materials may include, for example, bovine pericardium (or pericardium from other sources). The leaflets 158 may be secured to each other at their adjacent sides to form commissures 152, each of which may be secured to a respective commissure support structure 144 (also referred to in this disclosure as a “commissural support”) and / or other portions of the frame 102, as described in more detail below.

[0050] 1A and 1B, the valve structure 150 includes three leaflets 158 that can be configured to collapse in a tricuspid valve arrangement. Each leaflet 158 ​​may have an inflow edge 160 (which may also be referred to as a leaflet edge) ( FIG. 1A ). The inflow edges 160 of the leaflets 158 may be configured to define an undulating, curved, scalloped edge that generally circumferentially follows or tracks portions of the plurality of struts 112 of the frame 102 when the frame 102 is in a radially expanded configuration. The inflow edges 160 of the leaflets 158 may be referred to as a “scallop line.”

[0051] The prosthetic valve 100 may include one or more skirts attached around the frame 102. For example, as shown in FIG. 1B , the prosthetic valve 100 may include an outer skirt 103 attached around the outer surface of the frame 102. The outer skirt 103 may function as a sealing member for the prosthetic valve 100 by sealing against the tissue of the native annulus and helping to reduce paravalvular leakage through the prosthetic valve 100. In some cases, an inner skirt (not shown) may be attached around the inner surface of the frame 102. The inner skirt may function as a sealing member to prevent or reduce paravalvular leakage, secure the leaflets 158 to the frame 102, and / or protect the leaflets 158 from damage caused by contact with the frame 102 during crimping and during the work cycle of the prosthetic valve 100. In some examples, the inflow edges 160 of the leaflets 158 may be sutured to the inner skirt, generally along a scalloped line. The inner skirt may then be sutured to the adjacent struts 112 of the frame 102. In some examples, as shown in FIG. 1A , the leaflets 158 may be sutured directly to the frame 102 or to the reinforcement member 125 (also referred to as a reinforcement skirt or connecting skirt) in the form of a strip of material (e.g., a fabric strip), which is then sutured to the frame 102 along the scallop line via stitches (e.g., whip stitches) 133.

[0052] The inner and outer skirts, and connecting skirt 125, can be formed from any of a variety of suitable biocompatible materials, including any of a variety of synthetic materials, including woven fabrics (e.g., woven polyethylene terephthalate fabrics) or natural tissues (e.g., pericardial tissue). Further details regarding the use of skirts or sealing members in prosthetic valves can be found, for example, in U.S. Patent Publication No. 2020 / 0352711, which is incorporated herein by reference.

[0053] Further details regarding the assembly of the leaflet assembly and the assembly of the leaflets and skirt to the frame can be found, for example, in International Application No. PCT / US2022 / 032983, filed June 10, 2022, and U.S. Provisional Patent Application No. 63 / 224,534, filed July 22, 2021, which are incorporated herein by reference. Further details of the structure and function of frame 102 can be found in International Patent Application No. PCT / US2021 / 052745, filed September 30, 2021, which is incorporated herein by reference.

[0054] The frame 102, shown alone and in more detail in FIGS. 2A and 2B, includes an inflow end 109, an outflow end 108, and a plurality of axially extending posts 104. The axial direction of the frame 102 is indicated by a longitudinal axis 105 extending from the inflow end 109 to the outflow end 108 ( FIGS. 2A and 2B ). Some of the posts 104 may be arranged in axially aligned pairs of first and second struts or posts 122, 124. An actuator 126 (such as a threaded rod or bolt as shown) may extend through one or more pairs of posts 122, 124 to form an integrated expansion and locking mechanism or actuator mechanism 106 configured to radially expand and compress the frame 102, as described further below. One or more of the posts 104 may be configured as support posts 107.

[0055] The actuator mechanism 106 (which can be used to radially expand and / or radially compress the prosthetic valve 100) can be incorporated into the frame 102 of the prosthetic valve 100, thereby reducing the crimp profile and / or bulk of the prosthetic valve 100. Incorporating the actuator mechanism 106 (which may also be referred to in this disclosure as an "expansion and locking mechanism") into the frame 102 can also simplify the design of the prosthetic valve 100, making the prosthetic valve 100 less costly and / or easier to manufacture. In the illustrated example, an actuator 126 extends through each pair of axially aligned posts 122, 124. In some examples, one or more of the pairs of posts 122, 124 may not have a corresponding actuator.

[0056] The posts 104 may be coupled together by a plurality of circumferentially extending link members or struts 112. Each strut 112 extends circumferentially between adjacent posts 104, connecting all of the axially extending posts 104. As an example, the prosthetic valve 100 may include an equal number of support posts 107 and pairs of actuator posts 122, 124, as well as pairs of posts 122, 124, and the support posts 107 may be arranged in an alternating order such that each strut 112 is positioned between one of the pairs of posts 122, 124 and one of the support posts 107 (i.e., each strut 112 may have one end coupled to one of the posts 122, 124 and the other end coupled to one of the support posts 107). However, the prosthetic valve 100 may be configured to include a different number of support posts 107 and pairs of posts 122, 124, and / or the pairs of posts 122, 124 and support posts 107 may be arranged in a non-alternating order in some embodiments.

[0057] 2B , the struts 112 may include a first row of struts 113 at or near the inflow end 109 of the prosthetic valve 100, a second row of struts 114 at or near the outflow end 108 of the prosthetic valve 100, and a third row of struts 115 and a fourth row of struts 116 each axially disposed between the first row of struts 113 and the second row of struts 114. The struts 112 may be configured to form and / or define a plurality of cells (i.e., openings) within the frame 102. For example, the struts 113, 114, 115, and 116 may be configured to at least partially form and / or define a plurality of first cells 117 and a plurality of second cells 118 extending circumferentially around the frame 102. Specifically, each first cell 117 may be formed by two columns 113a, 113b of the first column 113, two columns 114a, 114b of the second column 114, and two support posts 107. Each second cell 118 may be formed by two columns 115a, 115b of the third column 115, and two columns 116a, 116b of the fourth column 116. As shown in Figures 2A and 2B, each second cell 118 may be located within one of the first cells 117 (i.e., the pillars 115a-116b forming the second cell 118 are closer to the center of the axial line of the frame 102 than the pillars 113a-114b, and are located between the pillars forming the first cell 117 (i.e., pillars 113a, 113b and pillars 114a, 114b)).

[0058] As shown in FIGS. 2A and 2B , the struts 112 of the frame 102 may have a curved shape. Each first cell 117 may have an axially extending hexagonal shape including first and second vertices 119 (e.g., inflow vertex 119 a and outflow vertex 119 b). In embodiments where a delivery device is removably connected to the outflow vertex 119 b (as described below), each inflow vertex 119 a may be referred to as a “distal vertex,” and each outflow vertex 119 b may be referred to as a “proximal vertex.” Each second cell 118 may have a diamond shape including first and second vertices 120 (e.g., distal vertex 120 a and proximal vertex 120 b). In some embodiments, the frame 102 includes six first cells 117 extending circumferentially in a row, six second cells 118 extending circumferentially in rows within the six first cells 117, and twelve posts 104. However, in some embodiments, the frame 102 can include a greater or lesser number of first cells 117 and a corresponding greater or lesser number of second cells 118 and posts 104.

[0059] As described above, some of the posts 104 may be arranged in pairs of first and second posts 122, 124. The posts 122, 124 are aligned with one another along the length of the frame 102 and axially spaced apart by a gap G (FIG. 2B) (those having actuators 126 may be referred to as actuator posts or actuator struts). Each first post 122 (i.e., the lower post shown in FIGS. 2A and 2B) may extend axially from the inflow end 109 of the prosthetic valve 100 toward the second post 124, and the second post 124 (i.e., the upper post shown in FIGS. 2A and 2B) may extend axially from the outflow end 108 of the prosthetic valve 100 toward the first post 122. For example, each first post 122 may be connected to and extend from the inflow apex 119a, and each second post 124 may be connected to and extend from the outflow apex 119b. Each of the first post 122 and second post 124 may include an internal bore configured to receive a portion of an actuator member, such as in the form of a substantially straight threaded rod 126 (or bolt), as shown in the illustrated embodiment. In this disclosure, the threaded rod 126 may also be referred to as the actuator 126, the actuator member 126, and / or the screw actuator 126. In embodiments in which the delivery device is removably connectable to the outflow end 108 of the frame 102, the first post 122 may be referred to as the distal post or distal axial post, and the second post 124 may be referred to as the proximal post or proximal axial post.

[0060] Each threaded rod 126 extends axially through a corresponding first post 122 and second post 124. Each threaded rod 126 also extends through a hole in a nut 127 captured in a slot or window formed in an end 128 of the first post 122. The threaded rod 126 has external threads that engage with internal threads of the hole in the nut 127. The inner hole of the second post 124 (through which the threaded rod 126 extends) may have a smooth and / or unthreaded inner surface to allow the threaded rod 126 to slide freely within the hole. Rotation of the threaded rod 126 relative to the nut 127 causes the frame 102 to radially expand and compress, as described further below.

[0061] In some embodiments, the threaded rod 126 may be configured to pass through the nut 127 and extend into an inner bore of the first post 122 toward the inflow end 109 of the frame 102. The nut 127 may be configured to be held in a fixed position relative to the first post 122 such that the nut 127 does not rotate relative to the first post 122. In this manner, whenever the threaded rod 126 is rotated (e.g., by a physician), the threaded rod 126 can rotate relative to both the nut 127 and the first post 122. The engagement of the external threads of the threaded rod 126 with the internal threads of the nut 127 prevents the rod 126 from moving axially relative to the nut 127 and the first post 122 unless the threaded rod 126 is rotated relative to the nut 127. Thus, threaded rod 126 may be held or supported by nut 127 and may move relative to nut 127 and / or first post 122 only by rotating threaded rod 126 relative to nut 127 and / or first post 122. In some embodiments, instead of using nut 127, at least a portion of the internal bore of first post 122 may be threaded. For example, a bore along end 128 of first post 122 may be configured with internal threads that engage with externally threaded rod 126 such that rotation of the threaded rod moves threaded rod 126 axially relative to first post 122.

[0062] When a threaded rod 126 extends through and / or is otherwise coupled to a pair of axially aligned posts 122, 124, the pair of axially aligned posts 122, 124 and the threaded rod 126 can function as one of the expansion and locking mechanisms 106. In some embodiments, a threaded rod 126 can be configured to extend through each pair of axially aligned posts 122, 124 such that all of the posts 122, 124 (with their corresponding rods 126) function as expansion and locking mechanisms 106. By way of example only, the prosthetic valve 100 can include six pairs of posts 122, 124, and each of the six pairs of posts 122, 124 with their corresponding rods 126 can be configured as one of the expansion and locking mechanisms 106, for a total of six expansion and locking mechanisms 106. In some embodiments, not all pairs of posts 122, 124 need be expansion and locking mechanisms (i.e., actuators). If the pair of posts 122, 124 is not used as an expansion and locking mechanism, the threaded rod 126 does not need to extend through the pair of posts 122, 124.

[0063] The threaded rod 126 can rotate relative to the nut 127, the first post 122, and the second post 124 to axially shorten and / or extend the frame 102, thereby radially expanding and / or radially compressing the frame 102 (and therefore the prosthetic valve 100), respectively. Specifically, as the threaded rod 126 rotates relative to the nut 127, the first post 122, and the second post 124, the first and second posts 122, 124 can move axially relative to one another, widening or narrowing the gap G ( FIG. 2B ) separating the posts 122, 124 and radially compressing or radially expanding the prosthetic valve 100, respectively. Thus, the gap G (FIG. 2B) between the first and second posts 122, 124 narrows as the frame 102 is radially expanded and widens as the frame 102 is radially compressed.

[0064] The threaded rod 126 may extend proximally beyond the proximal end of the second post 124 and may include a head portion 131 at its proximal end that can serve at least two functions. First, the head portion 131 can detachably or releasably couple the threaded rod 126 to a respective actuator assembly of a delivery device that can be used to radially expand and / or radially compress the prosthetic valve 100 (e.g., the delivery device 200 of FIG. 3 , described below). Second, the head portion 131 can prevent the second post 124 from moving proximally relative to the threaded rod 126 and can apply a distally directed force to the second post 124, such as when radially expanding the prosthetic valve 100. Specifically, the head portion 131 can have a width greater than the diameter of the inner bore of the second post 124 to prevent the head portion 131 from moving into the inner bore of the second post 124. Therefore, as the threaded rod 126 is threaded further into the nut 127, the head portion 131 of the threaded rod 126 is retracted closer to the nut 127 and the first post 122, thereby retracting the second post 124 toward the first post 122, and thereby shortening the prosthetic valve 100 axially and expanding it radially.

[0065] Threaded rod 126 may also include a stopper 132 (e.g., in the form of a nut, washer, or flange) disposed thereon. Stopper 132 may be disposed on threaded rod 126 such that it is located within gap G. Furthermore, stopper 132 may be integrally formed on or fixedly coupled to threaded rod 126 so as not to move relative to threaded rod 126. Thus, stopper 132 may remain in a fixed axial position on threaded rod 126 such that it moves in the same direction and at the same speed as threaded rod 126.

[0066] Rotation of threaded rod 126 in a first direction (e.g., clockwise) may cause corresponding axial movement of first post 122 and second post 124 toward one another, thereby decreasing gap G and radially expanding frame 102, while rotation of threaded rod 126 in an opposite second direction causes corresponding axial movement of first post 122 and second post 124 away from one another, thereby increasing gap G and radially compressing the frame. As threaded rod 126 rotates in the first direction, head portion 131 of rod 126 abuts an adjacent surface of the frame (e.g., outflow apex 119b), while nut 127 and first post 122 move proximally along threaded rod 126 toward second post 124, thereby radially expanding the frame. As the frame 102 moves from the compressed configuration to the expanded configuration, the gap G between the first and second posts 122, 124 can narrow.

[0067] As threaded rod 126 rotates in the second direction, threaded rod 126 and stopper 132 move toward the frame's outflow end 108 (as shown in FIGS. 2A and 2B) until stopper 132 abuts the inflow end 170 of second post 124. As rod 126 further rotates in the second direction, stopper 132 can apply a proximally directed force to second post 124, radially compressing frame 102. Specifically, during crimping / radial compression of the prosthetic valve 100, the threaded rod 126 can be rotated in a second direction (e.g., counterclockwise) to cause the stopper 132 to press against (i.e., provide a proximally directed force against) the inflow end 170 of the second post 124, causing the second post 124 to move away from the first post 122 and causing the prosthetic valve 100 to elongate axially and compress radially.

[0068] Thus, each of the second posts 124 can slide axially relative to a corresponding one of the first posts 122, but can be axially held and / or restrained between the head portion 131 and the stopper 132 of the threaded rod 126. That is, each second post 124 can be restrained at its proximal end by the head portion 131 of the threaded rod 126 and at its distal end by the stopper 132. In this manner, the head portion 131 can apply a distally directed force to the second post 124 to radially expand the prosthetic valve 100, while the stopper 132 can apply a proximally directed force to the second post 124 to radially compress the prosthetic valve 100. As described above, radially expanding the prosthetic valve 100 shortens the prosthetic valve 100 axially, causing the inflow and outflow ends 134, 136 (Figures 1A and 1B) of the prosthetic valve 100 to move axially toward each other, while radially compressing the prosthetic valve 100 lengthens the prosthetic valve 100 axially, causing the inflow and outflow ends 134, 136 to move axially away from each other.

[0069] In some embodiments, the threaded rod 126 can be fixed against axial movement relative to the second post 124 (and the stopper 132 can be omitted), such that rotation of the threaded rod 126 in a first direction moves the nut 127 proximally and expands the frame 102 radially, and rotation of the threaded rod 126 in a second direction moves the nut 127 distally and compresses the frame 102 radially.

[0070] As also described above, some of the posts 104 may be configured as support posts 107. As shown in Figures 2A and 2B, the support posts 107 may extend axially between the inflow and outflow ends 109, 108 of the frame 102 and each may have an inflow end 138 and an outflow end 139. The outflow ends 139 of one or more of the support posts 107 may include a commissure support structure or member 144. The commissure support structure 144 may include a strut portion defining a commissure opening 146 therein.

[0071] The commissure openings 146 (sometimes referred to in this disclosure as "commissure windows 146") may be configured to extend radially through the thickness of the support posts 107 and to receive a portion of the valvular structure 150 (e.g., a commissure 152) to couple the valvular structure 150 to the frame 102. For example, each commissure 152 may be attached to a respective commissure support structure 144 by, for example, inserting a pair of commissure tabs of adjacent leaflets 158 through the commissure openings 146 and suturing the commissure tabs to each other and / or to the commissure support structure 144. In some embodiments, the commissure openings 146 may be completely occluded by the support posts 107, allowing a portion of the valvular structure 150 to slide radially through the commissure openings 146 from the interior to the exterior of the frame 102 during assembly. In the illustrated embodiment, the commissure openings 146 have a substantially rectangular shape shaped and sized to receive the commissure tabs of two adjacent leaflets therethrough. However, in some embodiments, the commissure openings can have any of a variety of shapes, such as square, oval, square-oval, triangular, L-shaped, T-shaped, C-shaped, and the like.

[0072] The commissure openings 146 are spaced around the frame 102 (or angularly spaced around the frame 102). The spacing may or may not be uniform. In one embodiment, the commissure openings 146 are axially offset from the outflow end 108 of the frame 102 by an offset distance d3 (shown in FIG. 2A ). By way of example, the offset distance d3 may be in the range of 2 mm to 6 mm. Generally, the offset distance d3 should be selected such that the free edge (e.g., outflow edge) of the valve leaflet 158 ​​does not protrude beyond or beyond the outflow end 108 of the frame 102 when the leaflet is attached to the frame 102 via the commissure openings 146.

[0073] Frame 102 can include any number of support posts 107, any number of which can be configured as commissure support structures 144. For example, frame 102 can include six support posts 107, three of which can be configured as commissure support structures 144. However, in some embodiments, frame 102 can include more or fewer than six support posts 107 and / or more or fewer than three commissure support structures 144.

[0074] The inflow end 138 of each support post 107 may include an extension 154 (shown as a cantilevered strut in FIGS. 2A and 2B ) that extends toward the inflow end 109 of the frame 102. Each extension 154 may include an opening 156 that extends radially through the thickness of the extension 154. In some embodiments, the extension 154 may extend such that the inflow edge of the extension 154 aligns or substantially aligns with the inflow end 109 of the frame 102. In use, the extension 154 may prevent or reduce a portion of the outer skirt from extending radially inward, thereby preventing or reducing any blockage of flow through the frame 102 caused by the outer skirt. The extension 154 may further function as a support to which the inner and / or outer skirts, and / or the leaflets, and / or portions of the connecting skirt 125 may be coupled. For example, the sutures used to connect the inner and / or outer skirts, and / or the valve leaflets, and / or the connecting skirt 125 may be wrapped around the extension 154 and / or extend through the opening 156.

[0075] As one example, each extension 154 may have an opening 156 ( FIG. 2A ) or other configuration for receiving a suture or other attachment material to connect adjacent inflow edges 160 of the leaflets 158 ( FIG. 1A ), outer skirt 103 ( FIG. 1B ), connecting skirt 125, and / or inner skirt. In some examples, the inflow edges 160 of each leaflet 158 ​​may be connected to a corresponding extension via suture 135 ( FIG. 1A ).

[0076] In some embodiments, the outer skirt 103 can be attached around the outer surface of the frame 102, as shown in FIG. 1B , with the inflow edge (lower edge in FIG. 1B ) of the outer skirt 103 attached to the inflow edge 160 of the leaflet 158 ​​already secured to the connecting skirt 125 and / or frame 102, and to the frame extension 154 by sutures 129. The outflow edge (upper edge in FIG. 1B ) of the outer skirt 103 can be attached to selected struts by stitches 137. In implementations where the prosthetic valve includes an inner skirt, the inflow edge of the inner skirt can be secured to the inflow edge 160 before securing the leaflet edge to the frame, such that the inner skirt is between the leaflet and the inner surface of the frame. After the inner skirt and leaflets are secured in place, the outer skirt can be configured to fit around the frame as described above.

[0077] The frame 102 may be a unitary and / or fastener-less frame that can be constructed from a single piece of material (e.g., nitinol, stainless steel, or cobalt chromium alloy), such as in the form of a tube. Multiple cells may be formed by removing portions of the single piece of material (e.g., via laser cutting). The threaded rod 126 may be formed separately and inserted through a hole in the second (proximal) post 124 and threaded onto the threaded nut 127.

[0078] In some embodiments, frame 102 may be formed from a plastically expandable material, such as stainless steel or a cobalt-chromium alloy. If the frame is formed from a plastically expandable material, prosthetic valve 100 may be placed in a radially compressed state along the distal end portion of a delivery device for insertion into the patient's body. When at the desired implantation site, frame 102 (and thus prosthetic valve 100) may be radially expanded from the radially compressed state to a radially expanded state via actuation of the delivery device's actuation assembly (as described further below), which rotates rod 126 and expands frame 102. During delivery to the implantation site, prosthetic valve 100 may be mounted inside a delivery capsule (sheath) to protect it from contacting the patient's vasculature, such as when the prosthetic valve is advanced through the femoral artery. The capsule may also hold the prosthetic valve in a compressed state with a slightly smaller diameter and crimped profile than would be possible without the capsule by preventing any recoil (expansion) of the frame when crimped onto the delivery device.

[0079] In some embodiments, frame 102 can be formed from a self-expandable material (e.g., nitinol). If frame 102 is formed from a self-expandable material, the prosthetic valve can be radially compressed and placed within a capsule of a delivery device, and the prosthetic valve can be maintained in a radially compressed state during delivery to the implantation site. Once the desired implantation site is reached, the prosthetic valve is deployed, or released, from the capsule. In some embodiments, frame 102 (and thus prosthetic valve 100) can partially self-expand from a radially compressed state to a partially radially expanded state. Frame 102 (and thus prosthetic valve 100) can be further radially expanded from a partially expanded state to a further radially expanded state via actuation of an actuation assembly of the delivery device (as described further below), which rotates rod 126 to expand the frame.

[0080] As mentioned above, threaded rod 126 can removably couple prosthetic valve 100 to an actuator assembly of a delivery device. Referring to FIG. 3 , this shows an example of a delivery device 200 for delivering prosthetic valve 100 to a desired implantation location. Prosthetic valve 100 can be removably coupled to delivery device 200. It should be understood that delivery device 200, and other delivery devices disclosed in the present disclosure, can be used to implant prosthetic devices other than prosthetic valves, such as stents or grafts.

[0081] The delivery device 200 of the illustrated embodiment generally includes a handle 204, a first elongated shaft 206 (which, in the illustrated embodiment, comprises an outer shaft) extending distally from the handle 204, at least one actuator assembly 208 extending distally through the first shaft 206, a second elongated shaft 209 (which, in the illustrated embodiment, comprises an inner shaft) extending through the first shaft 206, and a nosecone 210 coupled to a distal end portion of the second shaft 209. The second shaft 209 and the nosecone 210 may be configured to define a guidewire lumen for advancing the delivery device over a guidewire through the patient's vasculature. The at least one actuator assembly 208 may be configured to radially expand and / or radially collapse the prosthetic valve 100 when actuated by one or more knobs 211, 212, 214, etc., included on the handle 204 of the delivery device 200.

[0082] While the illustrated embodiment shows two actuator assemblies 208 for illustrative purposes, it should be understood that one actuator assembly 208 may be provided for each actuator (e.g., actuator or threaded rod 126) on the prosthetic valve. For example, a prosthetic valve having three actuators may be configured with three actuator assemblies 208. In some embodiments, there may be more or fewer actuator assemblies 208.

[0083] In some embodiments, the distal end portion 216 of the shaft 206 can be sized to accommodate the prosthetic valve in its radially compressed delivery state during delivery of the prosthetic valve through the patient's vasculature. In this manner, the distal end portion 216 acts as a delivery sheath, or capsule, for the prosthetic valve during delivery. Furthermore, the distal end portion of the shaft can also be configured to accommodate various other implantable devices (e.g., stents, grafts, etc.).

[0084] The actuator assemblies 208 may be removably coupled to the prosthetic valve 100. For example, in the illustrated embodiment, each actuator assembly 208 may be coupled to a respective actuator (e.g., threaded rod 126) of the prosthetic valve 100. Each actuator assembly 208 may include a support tube and an actuator member. When actuated, the actuator assembly may transmit a pushing force and / or a pulling force to a portion of the prosthetic valve to radially expand and collapse the prosthetic valve, as described above. The actuator assemblies 208 may be at least partially radially disposed within and extend axially through one or more lumens of the first shaft 206. For example, the actuator assemblies 208 may extend through a central lumen of the shaft 206 or through separate lumens formed within the shaft 206.

[0085] The handle 204 of the delivery device 200 may be configured with one or more control mechanisms (e.g., knobs or other actuation mechanisms) for controlling different components of the delivery device 200 for purposes of expanding and / or deploying the prosthetic valve 100. For example, in the illustrated embodiment, the handle 204 includes first, second, and third knobs 211, 212, and 214, respectively.

[0086] The first knob 211 may be a rotatable knob configured to generate axial movement of the first shaft 206 in a distal and / or proximal direction relative to the prosthetic valve 100 to deploy the prosthetic valve from the delivery sheath 216 once the prosthetic valve has been advanced to or adjacent a desired implantation location within the patient. For example, rotation of the first knob 211 in a first direction (e.g., clockwise) may retract the sheath 216 proximally relative to the prosthetic valve 100, and rotation of the first knob 211 in a second direction (e.g., counterclockwise) may advance the sheath 216 distally. In some examples, the first knob 211 may be configured to be actuated by sliding or moving the first knob 211 axially, such as by pulling and / or pushing the knob. In some examples, actuation of the first knob 211 (rotation or sliding movement of the first knob 211) can generate axial movement of the actuator assembly 208 (and therefore the prosthetic valve 100) relative to the delivery sheath 216, advancing the prosthetic valve distally from the sheath 216.

[0087] The second knob 212 may be a rotatable knob configured to radially expand and / or compress the prosthetic valve 100. For example, rotation of the second knob 212 may rotate a threaded rod of the prosthetic valve 100 via the actuator assembly 208. Rotation of the second knob 212 in a first direction (e.g., clockwise) may radially expand the prosthetic valve 100, and rotation of the second knob 212 in a second direction (e.g., counterclockwise) may radially collapse the prosthetic valve 100. In some examples, the second knob 212 may be actuated by sliding or moving the second knob 212 axially, such as by pulling and / or pushing the knob.

[0088] The third knob 214 may be a rotatable knob operably connected to the proximal end portion of each actuator assembly 208. The third knob 214 may be configured to retract the outer sleeve or support tube of each actuator assembly 208 to disconnect the actuator assembly 208 from the proximal portion of the actuator of the prosthetic valve (e.g., a threaded rod). Once the actuator assembly 208 is decoupled from the prosthetic valve 100, the delivery device 200 may be removed from the patient, leaving only the prosthetic valve 100 in the patient.

[0089] 4-5, each figure illustrates how each of the threaded rods 126 of the prosthesis 100 may be configured to be removably coupled to an actuator assembly 300 (e.g., actuator assembly 208) of a delivery device (e.g., delivery device 200), according to one embodiment. Specifically, FIG. 5 illustrates how one of the threaded rods 126 may be coupled to the actuator assembly 300, and FIG. 4 illustrates how the threaded rod 126 may be removed from the actuator assembly 300.

[0090] As introduced above, the actuator assembly 300 may be coupled to the head portion 131 of each threaded rod 126. The head portion 131 may be included in the proximal end portion 180 of the threaded rod 126 and may extend proximally beyond the proximal end of the second post 124 (FIG. 2A). The head portion 131 may include first and second protrusions 182 defining a channel or slot 184 therebetween and one or more shoulders 186. As mentioned above, the head portion 131 may be configured to have a width greater than the diameter of the inner bore of the second post 124 such that the head portion 131 is prevented from moving into the inner bore of the second post 124 and the head portion 131 abuts the outflow end 108 of the frame 102. In particular, the head portion 131 may be configured to abut the outflow apex 119b of the frame 102. Head portion 131 can be used to apply a distally directed force to second post 124 , for example, during radial expansion of frame 102 .

[0091] Each actuator assembly 300 may include a first actuation member configured as a support tube or outer sleeve 302 and a second actuation member configured as a driver 304. The driver 304 may extend through the outer sleeve 302. The outer sleeve 302 is shown transparent in FIGS. 4-5 for illustrative purposes. The distal end portions of the outer sleeve 302 and the driver 304 may be configured to engage or abut the threaded rod 126 (e.g., head portion 131) and / or the proximal end (e.g., apex 119b) of the frame 102. The proximal portions of the outer sleeve 302 and the driver 304 may be operably coupled to a handle (e.g., handle 204) of a delivery device. The delivery device of this example may include the same components described above for the delivery device 200. In certain embodiments, a proximal end portion of each driver 304 may be operably connected to knob 212 such that rotation (clockwise or counterclockwise) of knob 212 causes corresponding rotation of driver 304. A proximal end portion of each outer sleeve 302 may be operably connected to knob 214 such that rotation (clockwise or counterclockwise) of knob 214 causes corresponding axial movement (proximal or distal) of sleeve 302 relative to driver 304. In some embodiments, the handle may include an electric motor for actuating these components.

[0092] The distal end portion of driver 304 may include a central protrusion 306 configured to extend into slot 184 of threaded rod 126 and one or more flexible elongated elements or arms 308 including protrusions or teeth 310 configured to be removably coupled to shoulder 186 of threaded rod 126. Protrusions 310 may extend radially inward toward the longitudinal axis of second actuation member 304. As shown in FIGS. 4-5 , elongated elements 308 may be configured to be biased radially outward to an expanded state, for example, by the shape of elements 308.

[0093] 5, to couple the actuator assembly 300 to the threaded rod 126, the driver 304 may be configured such that the central protrusion 306 is disposed within the slot 184 (FIG. 4) and the protrusion 310 of the extended element 308 is disposed distally of the shoulder 186. When the outer sleeve 302 is advanced (e.g., distally) over the driver 304, the sleeve 302 compresses the extended element 308 so that it abuts and / or snaps against the shoulder 186, thereby coupling the actuator assembly 300 to the threaded rod 126. Thus, the outer sleeve 302 effectively compresses and locks the extended element 308 and the protrusion 310 of the driver 304 into engagement with (i.e., on) the shoulder 186 of the threaded rod 126, thereby coupling the driver 304 to the threaded rod 126.

[0094] Because the central protrusion 306 of the driver 304 extends into the slot 184 of the threaded rod 126 when the driver 304 and the threaded rod 126 are coupled, the driver 304 and the threaded rod 126 can be rotationally locked such that they co-rotate. Once so coupled, the driver 304 can be rotated (e.g., using the knob 212 on the handle of the delivery device 200) and a corresponding rotation of the threaded rod 126 can radially expand or radially compress the prosthesis. The central protrusion 306 can be configured (e.g., sized and shaped) to be advantageously spaced from the inner wall of the outer sleeve 302 so that the central protrusion 306 does not come into frictional contact with the outer sleeve 302 during rotation. In the illustrated example, the central protrusion 306 has a substantially rectangular cross-sectional shape, although in some examples, the protrusion 306 can have any of a variety of shapes, such as a square, a triangle, an oval, etc. The slot 184 may be correspondingly shaped to receive the protrusion 306 .

[0095] The outer sleeve 302 can be advanced distally relative to the driver 304 through the elongated element 308 until the outer sleeve 302 engages the frame 102 (e.g., the second post 124 of the frame 102). The distal end portion of the outer sleeve 302 can also include first and second support extensions 312 that define a gap or notch 314 between the extensions 312. The support extensions 312 can be oriented such that when the actuator assembly 300 is coupled to each threaded rod 126, the support extensions 312 extend partially onto opposite sides of the posts 124 and onto one adjacent end (e.g., the upper end) of the second post 124. In this manner, engagement of the support extensions 312 with the frame 102 can counteract rotational forces applied to the frame 102 by the rod 126 during expansion of the frame 102. Without a counter force acting against these rotational forces, the frame may tend to "shock" or rock in the direction of the rod rotation when actuated to expand the frame. The illustrated configuration is advantageous in that the outer sleeve, when engaged with the proximal post 124 of the frame 102, can prevent or mitigate such shock or rocking movement of the frame 102 when the frame 102 is radially expanded.

[0096] To separate the actuator assembly 300 from the prosthesis 100, the sleeve 302 can be withdrawn proximally relative to the driver 304 until the sleeve 302 no longer covers the extended element 308 of the driver 304. As described above, the extended element 308 can be naturally biased to a radially outward position where the extended element 308 does not engage the shoulder 186 of the threaded rod 126, and thus the sleeve 302 can be used to hold the extended element 308 against the shoulder 186 of the threaded rod 126. Thus, when the sleeve 302 is withdrawn so that it no longer covers / restrains the extended element 308, the extended element 308 naturally and / or passively deflects and thereby releases from the shoulder 186 of the threaded rod 126, thereby allowing the driver 304 to separate from the threaded rod 126.

[0097] The sleeve 302 may be configured to be advanced (moved distally) and / or retracted (moved proximally) relative to the driver 304 by an electric motor and / or another suitable actuation mechanism via a control mechanism (e.g., knob 214) on the handle 204 of the delivery device 200. For example, a physician may rotate the knob 214 in a first direction to apply a distally directed force to the sleeve 302, and rotate the knob 214 in an opposite second direction to apply a proximally directed force to the sleeve 302. Thus, when the sleeve 302 is not abutting the prosthesis and the physician rotates the knob 214 in a first direction, the sleeve 302 may move distally relative to the driver 304, thereby advancing the sleeve 302 over the driver 304. When the sleeve 302 abuts the prosthesis, the physician may rotate the knob 214 in a first direction to push the entire prosthesis distally through the sleeve 302. Additionally, when the physician rotates the knob 214 in a second direction, the sleeve 302 may be configured to move proximally relative to the driver 304 , thereby withdrawing / retracting the sleeve 302 from the driver 304 .

[0098] 6 illustrates an example of a delivery device 400. The delivery device 400 may be configured to provide for manipulation of the radius of curvature of the shaft of the delivery device 400, for example, independent of axial displacement of the shaft relative to other components of the delivery device. For example, the shaft of the delivery device 400 may be configured to be retracted relative to a prosthetic implant coupled to the delivery device 400 via a shaft displacement mechanism without adjusting the radius of curvature of the shaft. Similarly, the delivery device 400 may be configured to allow adjustment of the curvature of the shaft via a shaft adjustment mechanism without changing the axial position of the shaft relative to the prosthetic implant.

[0099] Similar to delivery device 200, a prosthetic valve (e.g., a mechanically expandable prosthetic valve such as prosthetic valve 100 described herein, a self-expandable prosthetic valve, a balloon-expandable prosthetic valve, etc.) may be configured to be removably coupled to delivery device 400. It should be understood that delivery device 400 and other delivery devices disclosed in the present disclosure may be used to implant prosthetic devices other than prosthetic valves, such as stents or grafts.

[0100] The delivery device 400 in the illustrated example generally includes a handle 404, a first elongated shaft 406 extending distally from the handle 404, and at least one expansion mechanism 408 extending distally through the first shaft 406 (FIG. 7). Although not shown, a prosthetic device, such as a prosthetic heart valve, can be coupled to the expansion mechanism 408. The expansion mechanism 408 can be one of the expansion mechanisms described herein (e.g., one or more of the actuator assemblies described herein, such as a balloon for a balloon-expandable prosthesis, an inner shaft having a self-expandable prosthesis disposed on its outer surface, etc.), or other types of expansion mechanisms suitable for an expandable prosthesis.

[0101] In some embodiments, the distal end portion of shaft 406 can be sized to accommodate the prosthetic valve in its radially compressed delivery state (e.g., coupled to expansion mechanism 408) during delivery of the prosthetic valve through the patient's vasculature. In this manner, the distal end portion of shaft 406 functions as a delivery sheath or capsule for the prosthetic valve during delivery. Further details regarding delivery capsules and delivery capsule retraction are described, for example, in U.S. Provisional Patent Application No. 63 / 322,974, filed March 23, 2022, which is incorporated herein by reference.

[0102] The handle 404 of the delivery device 400 may include one or more control mechanisms (e.g., knobs or other actuation mechanisms) for controlling different components of the delivery device 400 for purposes of expanding and / or deploying the prosthetic valve. For example, in the illustrated embodiment, the handle 404 includes first, second, and third knobs 411, 412, and 414, respectively.

[0103] The first knob 411 (also referred to in the present disclosure as a "flex knob") may be a rotatable knob configured to assist in advancing and / or positioning the delivery shaft 406 in or adjacent to a patient's body and a desired implantation location. For example, the first knob 411 may be configured to allow a user to adjust the distal end portion of the delivery shaft 406 to bend, flex, twist, rotate, and / or otherwise articulate the delivery shaft 406 to assist in advancing and / or positioning the delivery shaft 406 for deployment of a prosthetic valve at an implantation site. For example, rotating the first knob 411 in a first direction (e.g., clockwise) relative to the handle 404 may increase the curvature of the shaft 406, and rotating the first knob 411 in a second direction (e.g., counterclockwise) relative to the handle 404 may decrease the curvature of the shaft 406. In some embodiments, the first knob 411 may be configured to be actuated by sliding or moving the first knob 411 axially, such as by pulling and / or pushing the knob.

[0104] The second knob 412 (also referred to in the present disclosure as the "shaft displacement knob") may be a rotatable knob configured to generate axial movement of the first shaft 406 in a distal and / or proximal direction relative to the prosthetic valve to deploy the prosthetic valve from the delivery shaft 406 as the prosthetic valve is advanced to or adjacent the desired implantation location. For example, rotating the second knob 412 in a first direction (e.g., clockwise) relative to the handle 404 may retract the shaft 406 proximally relative to the prosthetic valve, and rotating the second knob 412 in a second direction (e.g., counterclockwise) relative to the handle 404 may advance the shaft 406 distally. In some examples, the second knob 412 may be configured to be actuated by sliding or moving the second knob 412 axially, such as by pulling and / or pushing the knob. In some embodiments, actuation of the second knob 412 (rotation or sliding movement of the second knob 412) may be configured to generate axial movement of the expansion mechanism 408 (and therefore the prosthetic valve) relative to the shaft 406, advancing the prosthetic valve distally from the shaft 406.

[0105] The third knob 414 (also referred to in this disclosure as an "actuation knob") may be a rotatable knob configured to radially expand and / or compress the prosthetic valve. For example, in connection with a mechanically expandable prosthesis, rotation of the third knob 414 may rotate an actuator of the prosthetic valve via the expansion mechanism 408. Rotating the third knob 414 in a first direction (e.g., clockwise) relative to the handle 404 may radially expand the prosthetic valve, and rotating the third knob 414 in a second direction (e.g., counterclockwise) relative to the handle 404 may radially collapse the prosthetic valve. In some embodiments, in connection with a balloon-expandable prosthesis, rotation of the third knob 414 may cause inflation of the balloon expansion mechanism 408. In some embodiments, the third knob 414 may be omitted, for example, in connection with a self-expandable prosthesis. In some examples, the third knob 414 may be actuated by sliding or moving the third knob 414 axially, such as by pulling and / or pushing the knob.

[0106] The handle 404 of the delivery device 400 may be configured to include one or more indicator mechanisms, such as indicator 416. The indicator 416 (also referred to in this disclosure as a "flexion indicator") may be operably coupled to the first knob 411 and may be configured to indicate the amount of flex or curvature of the shaft 406 as the first knob 411 is rotated, as described in more detail below. As shown, the indicator 416 may include indicia such as alphanumeric characters, laterally aligned hash marks, graphics, etc. to visually indicate the amount of curvature of the shaft 406.

[0107] 6 , indicator 416 is disposed at a distal end 418 of handle 404. In some embodiments, as shown, first knob 411 may be disposed proximal to indicator 416. Second knob 412 may be disposed proximal to first knob 411. Third knob 414 may be disposed at a proximal end 420 of handle 404 and may be configured proximal to first knob 411 and second knob 412. In some embodiments, indicator 416 and knobs 411, 412, and 414 may be disposed in a different order, for example, third knob 414 may be disposed at distal end 418 of handle 404.

[0108] The handle 404 may also include an outer housing 422. As shown in FIG. 7 , within the housing 422 and / or one or more of the knobs 411, 412, etc., the handle 404 may include an expansion mechanism 408, an adjustment mechanism 424 for adjusting the bend or curvature of the delivery shaft 406, and a displacement mechanism 426 for axially displacing the delivery shaft 406 relative to the expansion mechanism 408. In some examples, the housing 422 may be integrally formed as a single, unitary component. In other examples, the housing 422 may include one or more segments formed as separate components that are coupled together (e.g., via fasteners, adhesive, mating features, and / or other coupling means).

[0109] In some embodiments, as shown, adjustment mechanism 424 can be coupled to displacement mechanism 426. Specifically, delivery device 400 can include a connector shaft 428 for coupling adjustment mechanism 424 and displacement mechanism 426.

[0110] The adjustment mechanism 424 may be operably coupled to the first knob 411. In some examples, the distal end portion of the delivery shaft 406 may be configured to be steerable via the adjustment mechanism 424 based on rotation of the first knob 411 relative to the housing 422. For example, by rotating the knob 411, the curvature of the distal end portion of the delivery shaft 406 may be adjusted such that the distal end portion of the delivery shaft 406 can be oriented at a desired angle. Specifically, for implantation of a prosthesis (e.g., prosthetic valve 100, etc.), the distal end portion of the delivery shaft 406 may be configured to orient the prosthetic valve so that it can be positioned at a target implantation location.

[0111] In addition to the knob 411, the adjustment mechanism 424 (also referred to in this disclosure as a "flex assembly") may include a pull wire 430, as shown in FIG. 7. The adjustment mechanism 424 may be configured to direct the distal end portion of the delivery shaft 406 via the knob 411 and the pull wire 430 by increasing or decreasing the tension in the pull wire 430. Specifically, the distal end of the pull wire 430 may be connected to the distal end portion of the delivery shaft 406. As the tension in the pull wire 430 changes, the curvature of the distal end portion of the delivery shaft 406 changes in response to the tension in the pull wire 430.

[0112] The adjustment mechanism 424 may also include a flex nut 432 and a flex lead member 434 for axially displacing the pull wire 430 relative to the handle 404. For example, the pull wire 430 may extend proximally within the handle 404, with the proximal end of the pull wire 430 connected to the flex nut 432 (FIG. 9). As described in more detail below, the flex nut 432 may be configured for axial translation relative to the flex lead member 434.

[0113] In some embodiments, delivery device 400 may also include one or more gear assemblies 472 for coupling knob 411 to other components of adjustment mechanism 424 disposed within handle 404, as described in more detail below. For example, each gear assembly 472 may include one or more first (or proximal) gears 436, one or more rods 438, and one or more second (or distal) gears 440.

[0114] As shown, gear assembly 472 allows flex nut 432 and flex lead member 434 of adjustment mechanism 424 to be positioned (or move proximally) proximal to at least a portion of a component of displacement mechanism 426 within handle 404 (such as carriage 464 of displacement mechanism 426). Gear assembly 472 may be configured to allow adjustment mechanism 424 to be positioned generally proximal to displacement mechanism 426, even though knob 411 corresponding to adjustment mechanism 424 is distal to knob 412 corresponding to displacement mechanism 426. For example, rod 438 may be configured to generally extend at least a portion of the length of handle 404, and rod 438 may extend proximally from gear 440, through carriage 464 of displacement mechanism 426, and to at least gear 436, which may be coupled to flex lead member 434 of adjustment mechanism 424. In some examples, rod 438 need not extend through carriage 464 of displacement mechanism 426.

[0115] As shown in FIGS. 8-9 , the flex nut 432 includes an attachment member 442 (also referred to as a “wire wrap”) for coupling the pull wire 430 to the flex nut 432. The attachment member 442 can be configured to secure the proximal end of the pull wire 430 thereto (e.g., by wrapping the end of the pull wire 430 around the attachment member 442). As shown, the attachment member 442 extends radially from a body 444 of the flex nut 432. In some embodiments, as shown, the attachment member 442 can include a radial protrusion 446 and a pin 448 extending axially from the protrusion 446. In this manner, the pin 448 can be radially offset from the body 444. The pull wire 430 can be wrapped around the protrusion 446 and the pin 448 to couple the pull wire 430 to the attachment member 442. In some embodiments, wrapping the pull wire 430 around the pin 448 can result in plastic deformation of the pull wire 430. In this manner, the plastic deformation of the pull wire 430 can help prevent the pull wire 430 from becoming separated or unraveling from the attachment member 442 .

[0116] In some embodiments, the pull wires may be coupled to the flex nut in a variety of other ways, such as using fasteners, adhesives, and / or other coupling means.

[0117] The flex nuts 432 may be disposed around the connector shaft 428 such that the connector shaft 428 extends through an opening in the flex nut 432. The flex nut 432 may be configured to translate axially relative to the connector shaft 428 to adjust the tension of the pull wire 430. In some examples, as described in more detail below, rotation of the flex lead members 434 may result in axial translation of the flex nut 432 relative to the connector shaft 428. Each flex nut 432 may include one or more notches 450 that may be configured to prevent rotational movement of the flex nut 432 relative to the connector shaft 428 during axial translation of the flex nut 432 along the connector shaft 428. In particular, the notches 450 in the flex nut 432 may be configured to engage with guides 452 on the connector shaft 428 when the flex nut 432 is moved axially by the flex lead members 434. In this manner, the guide 452 can prevent rotational movement of the flex nut 432 while allowing the flex nut 432 to move axially relative to the connector shaft 428 and flex lead member 434 .

[0118] As shown in FIG. 8 , the guide 452 may be a protrusion from the outer surface of the connector shaft 428 that extends along the length of the connector shaft 428. For example, the guide 452 may extend from the distal end of the connector shaft 428 to a flange 454 at the proximal end of the connector shaft 428. The flange 454 may include an opening 456 for the rod 438 to pass through (e.g., as shown in FIG. 12 ). While two notches 450 and two corresponding guides 452 are shown in the illustrated embodiment, some embodiments may include more or fewer notches 450 and guides 452.

[0119] The connector shaft 428 may include an axially extending slot 458 at its distal end that allows the pull wire 430 to pass from a radially inward location on the connector shaft 428 (e.g., the distal end of the delivery shaft 406) to a radially outward location on the connector shaft 428 (e.g., the attachment member 442). In some embodiments, as shown, the connector shaft 428 includes a central lumen 460. As shown in FIG. 10 , for example, the expansion mechanism 408 is disposed within and extends through the lumen 460.

[0120] 9 , the body 444 of the flex nut 432 includes external threads 433 that can mate with the internal threads 435 of the flex lead member 434. Specifically, the flex lead member 434 can include an inner surface 462 that defines an inner lumen and the internal threads 435, and the external threads 433 of the flex nut 432 can be configured to threadably mate with the threads 435 of the inner surface 462. As described in more detail below, the flex nut 432 is permitted to translate axially within the flex lead member 434 along the threads 435 of the inner surface 462 and along the connector shaft 428 based on rotation of the first knob 411 relative to the handle 404.

[0121] As described above, the connector shaft 428 may be coupled to the adjustment mechanism 424 and the displacement mechanism 426. Specifically, the distal end of the connector shaft 428 may be coupled to the carriage 464 of the displacement mechanism 426. In some embodiments, as shown, a pin 466 is used to couple the connector shaft 428 to the carriage 464. In some embodiments, the connector shaft 428 may be coupled to the carriage 464 in other manners, such as with adhesive, a friction fit, or other coupling mechanisms. At the proximal end of the connector shaft 428, a flange 454 may be coupled to the rod 438, and the flange 454 may abut the proximal ends of the flex lead member 434 and the proximal gear 436 (e.g., as shown in FIG. 12 ). In some embodiments, the flex lead member 434 may be disposed around the connector shaft 428, and the rod 438 may extend through an opening 456 in the flange 454 (e.g., as shown in FIG. 12 ). The rod 438 may be rotatable relative to the connector shaft 428 within the opening 456. The proximal gear 436 may be disposed on the rod 438 and may be configured to be coupled (e.g., rotatably coupled) to an outer surface of the flex lead member 434 (e.g., as shown in FIG. 11 ). In some embodiments, the proximal gear 436 is fixedly coupled to the rod 438.

[0122] The flex lead member 434 (also referred to in this disclosure as a "barrel" or "adjustment barrel") may have an inner surface 462 and an outer surface 468, as shown in FIG. 10. In some embodiments, the inner surface 462 is threaded, as shown, and the outer surface 468 includes external teeth, as shown in FIG. 11. As described above, the body 444 of the flex nut 432 includes external threads 433 that engage the internal threads 435 of the flex lead member 434, as shown in FIG. 9. The teeth on the outer surface 468 mesh with the teeth of the proximal gear 436. Thus, when the proximal gear 436 rotates due to rotation of the rod 438, the flex lead member 434 also rotates. The threaded connection between the flex lead member 434 and the flex nut 432 (i.e., the connection between the outer threads 433 of the flex nut 432 and the inner threads 435 of the flex lead member 434) allows the flex nut 432 (and therefore the pull wire 430) to be displaced axially (along the connector shaft 428 and within the flex lead member 434) to change the tension in the pull wire 430 and adjust the curvature or bend of the distal end portion of the delivery shaft 406.

[0123] 7 and 11 , the proximal gear 436 extends axially along the rod 438 and spans at least a portion of the length of the flex lead member 434. The length of the proximal gear 436 may be equal to the axial length between the carriage 464 and the flange 454. In some embodiments, the proximal gear 436 does not extend the entire axial length of the flex lead member 434. In some embodiments, one or more axially smaller gears 436 may be mounted on the rod 438 and coupled to the outer surface 468 of the flex lead member 434 (e.g., axially between the carriage 464 and the flange 454). Additionally, one or more optional spacers may be axially mounted on the rod 438 between the carriage 464, the gear(s), and / or the flange 454. In some instances, the combined axial length of the gear(s) and spacer(s) may be equal to the axial length of the flex lead member 434.

[0124] The proximal gear 436 and the distal gear 440 may be configured to couple to the rod 438 such that the gears 436, 440 are not permitted to rotate relative to the rod 438. For example, the rod 438 may be configured to be shaped (e.g., D-shaped) such that the rod 438 mates with corresponding openings in the gears 436, 440.

[0125] 12 and 13, the knob 411 is coupled to the rod 438 via the distal gear 440. Specifically, the knob 411 includes internal teeth 470 that mesh with (e.g., engage) the teeth of the distal gear 440. In some embodiments, as shown in FIG. 12, the adjustment mechanism 424 includes two groups of one proximal gear 436, one rod 438, and one distal gear 440. For example, each group 472 (also referred to as a "gear assembly 472") is circumferentially spaced apart such that the gear assemblies 472 are evenly spaced around the handle 404. While two gear assemblies 472 are included in the illustrated embodiment, other embodiments may include a different number of gear assemblies 472 (e.g., one, three, four, etc.). In some embodiments, each gear assembly 472 may include a different number of gears and / or rods (e.g., two proximal gears 436, one rod 438, one distal gear 440, etc.). In some embodiments, each gear assembly 472 may include a different configuration of gears or rods that operably couple knob 411 to flex lead member 434.

[0126] As described above, the delivery device 400 may also include a displacement mechanism 426 configured to axially displace the delivery shaft 406 relative to the expansion mechanism 408 (e.g., to retract the delivery shaft 406 relative to a prosthetic heart valve coupled to the expansion mechanism 408). Referring again to FIG. 7 , the displacement mechanism 426 may include a second knob 412 and a carriage 464 (also referred to in this disclosure as a “displacement nut 464” or “displacement member 464”). As described in more detail below, rotation of the knob 412 relative to the handle 404 may drive axial displacement of the carriage 464 (and the shaft 406 coupled thereto) relative to the handle 404.

[0127] The knob 412 may include an outer grip portion 474 and a barrel portion 476 (e.g., as shown in FIGS. 7 and 14A ). The grip portion 474 is configured for a user to engage and rotate the knob 412 relative to the handle 404. Rotation of the knob 412 (and thus the barrel portion 476) is configured to axially displace one or more components of the shaft displacement mechanism 426 (e.g., the displacement nut 464) relative to the barrel portion 476. In some embodiments, as shown, the barrel portion 476 may be radially disposed within the grip portion 474 and may extend proximally from the grip portion 474 within the outer housing 422. As shown in FIG. 7 , the displacement nut 464, the connector shaft 428, and one or more components of the adjustment mechanism 424 may be disposed within the barrel portion 476 of the knob 412. In some embodiments, as shown, the knob 412 may be integrally formed as a single, unitary component. In some embodiments, knob 412 may include one or more segments formed as separate components that are coupled together (e.g., via fasteners, adhesive, mating features, and / or other coupling means). For example, grip portion 474 and barrel portion 476 may each be formed as separate components that are coupled together.

[0128] The barrel portion 476 may include a threaded inner surface 478, and the displacement nut 464 may include a corresponding threaded outer surface 480. The displacement nut 464 may be disposed within the barrel portion 476 with the threaded outer surface 480 coupled to the inner surface 478. In this manner, rotation of the knob 412 can cause the displacement nut 464 to translate axially within the barrel portion 476 via the threaded connection between the surfaces 478, 480. In some embodiments, as shown, the displacement nut 464 may have an opening through which the rod 438 extends. As the displacement nut 464 is axially displaced, for example, as a result of rotation of the knob 412, the nut 464 translates axially along the rod 438. In addition to the displacement nut 464 being configured to translate axially relative to the rod 438, the rod 438 may be rotatable within the opening of the displacement nut 464, for example, as a result of rotation of the first knob 411.

[0129] The displacement nut 464 may be coupled to the proximal end portion 482 of the delivery shaft 406. In this manner, displacement of the nut 464 results in displacement of the delivery shaft 406.

[0130] 9 , the proximal end portion 482 of the delivery shaft 406 may also be coupled to the connector shaft 428. For example, the proximal end portion 482 of the delivery shaft 406 may be positioned within the lumen 460 of the connector shaft 428 and coupled to the connector shaft 428 (e.g., with an adhesive, etc.). In such an example, the connector shaft 428 may be coupled to the displacement nut 464, for example, via a pin 466. In this manner, the relative axial positioning of the delivery shaft 406, the displacement nut 464, and the connector shaft 428 may be fixed such that axial displacement of one of these components results in axial displacement of the other components.

[0131] For example, rotation of knob 412 can cause displacement nut 464 to translate axially within barrel portion 476 via the threaded connection of surfaces 478, 480, which can result in axial translation of delivery shaft 406 and connector shaft 428. Specifically, displacement nut 464 can be configured to translate axially relative to expansion mechanism 408 such that delivery shaft 406 can be retracted relative to expansion mechanism 408.

[0132] Figures 14A-15B illustrate in more detail the operation of the displacement mechanism 426. Specifically, Figures 14A-14B illustrate the operation of the components of the displacement mechanism 426 disposed within the handle 404, and Figures 15A-15B schematically illustrate the displacement of the delivery shaft 406 relative to the prosthetic valve 100 as a result of the operation shown in Figures 14A-14B.

[0133] 14A illustrates the displacement nut 464 in a first axial position within the handle 404, e.g., before rotation of the knob 412 in a first direction relative to the handle 404. FIG. 14B illustrates the displacement nut 464 in a second axial position within the handle 404, e.g., after rotation of the knob 412 in the first direction. As illustrated, the first axial position is distal to the second axial position. In some embodiments, rotating the knob 412 in a first direction may result in proximal translation of the displacement nut 464, while rotating the knob 412 in a second direction relative to the handle 404 (e.g., opposite the first direction) may result in distal translation of the displacement nut 464.

[0134] When the displacement nut 464 is in a first axial position ( FIG. 14A ), the distal end 406 d of the delivery shaft 406 is in a first position relative to the prosthetic valve 100 and the expansion mechanism 408 ( FIG. 15A ). When the displacement nut 464 is in a second axial position ( FIG. 14B ), the distal end 406 d of the delivery shaft 406 is in a second position relative to the prosthetic valve 100 and the expansion mechanism 408 ( FIG. 15B ). In the illustrated example, the delivery shaft 406 is partially retracted relative to the prosthetic valve 100 in the second position. As described in more detail below, the shaft displacement mechanism 426 operates independently of the shaft adjustment mechanism 424 such that the shaft displacement mechanism 426 can be operated without adjusting the curvature of the shaft 406. For example, the curvature of the delivery shaft 406 is substantially the same in the first position ( FIG. 15A ) as it is in the second position ( FIG. 15B ). This configuration may be useful when the prosthetic valve 100 is implanted in a target location that requires the delivery shaft 406 to bend during implantation of the prosthetic valve 100, such as when the delivery shaft 406 is positioned within the aortic arch 10.

[0135] When in the first axial position, the distal surface of the displacement nut 464 can abut the base member 484 of the handle 404 (as shown in FIG. 14A ). In some embodiments, as shown, the base member 484 can have a recess 486 such that at least a portion of the displacement nut 464 can fit within the recess 486 when in the first axial position. A distal end portion 488 of the base member 484 can be coupled to a cap 490 at the distal end 418 of the handle 404. The axial positions of the base member 484 and cap 490 can be fixed relative to the handle 404 (e.g., fixed relative to the knobs 411, 412, relative to the housing 422, relative to the expansion mechanism 408, etc.).

[0136] In some embodiments, as shown, gear 440 may be positioned adjacent a distal surface of base member 484 and circumferentially disposed about distal end portion 488 of base member 484. Rod 438 coupled to gear 440 may, in some examples, extend through base member 484. Specifically, as shown in FIG. 14A , base member 484 may have an opening through which rod 438 extends. Rod 438 is rotatable relative to base member 484, for example, as a result of rotation of first knob 411.

[0137] The knob 412 can be rotated relative to the handle 404 to adjust the axial positioning of the distal end 406d of the delivery shaft 406 relative to the expansion mechanism 408 and the prosthetic valve 100. For example, a user can engage the grip portion 474 and rotate the knob 412. When the knob 412 is rotated in a first direction 492, the threaded connection between the barrel portion 476 of the knob 412 and the displacement nut 464 can drive the displacement nut 464 axially such that the displacement nut 464 is translated (e.g., proximally) along the rod 438. Because the proximal end portion 482 of the delivery shaft 406 is fixedly coupled to the displacement nut 464, the shaft 406 is also translated axially (e.g., proximally) relative to the prosthetic valve 100 and the expansion mechanism 408. As shown in Figures 15A-15B, the axially translating shaft 406 allows the prosthetic valve 100 (and in some embodiments, the expansion mechanism 408) to be unsheathed from the distal end 406d of the shaft 406, for example, to allow radial expansion of the prosthetic valve 100 coupled to the expansion mechanism 408.

[0138] Additionally, due to the pinned connection 466 between the displacement nut 464 and the connector shaft 428, the connector shaft 428 and components of the adjustment mechanism 424 are also driven axially by the displacement nut 464. For example, rotation of the second knob 412 in the first direction 492 can result in axial displacement (e.g., proximal displacement) of the connector shaft 428, pull wire 430, flex nut 432, flex lead member 434, and proximal gear 436. In this manner, as the knob 412 rotates, both the shaft 406 and the pull wire 430 (coupled to the distal end of the shaft 406) are axially displaced by the same amount (equal to distance D1). This allows the axial position of the shaft 406 to be adjusted relative to the expansion mechanism 408 (and prosthetic valve 100) without changing the tension in the pull wire 430 and / or the radius of curvature of the distal end of the shaft 406. This may allow the prosthetic valve 100 to be deployed from the distal end of the shaft 406 without changing the curvature of the shaft 406, as shown, for example, in Figures 15A-15B. In this manner, the delivery device 400 may, among other things, improve the process of implanting a prosthesis and / or reduce the time of the implantation procedure.

[0139] As shown in FIG. 14B , after the knob 412 is rotated in the first direction 492, the nut 464 is displaced (e.g., proximally) a distance D1 relative to the base member 484. This distance may be equal to the displacement of the distal end 406d of the shaft 406 relative to the prosthetic valve 100 ( FIG. 15B ). In some embodiments, the knob 412 may be rotated in the first direction 492 several rotations, e.g., one or more rotations, to fully retract the shaft 406 relative to the prosthetic valve 100 coupled to the distal end portion of the expansion mechanism 408 ("full decapsulation"). As described above, rotation of the knob 412 in the second direction relative to the handle 404 may result in distal translation of the displacement nut 464, e.g., to advance the shaft 406 over the prosthesis and / or expansion mechanism 408.

[0140] 16-17 illustrate the operation of the adjustment mechanism 424 in more detail. Specifically, FIG. 16 illustrates the flex nut 432 in a first axial position relative to the flex lead member 434, e.g., before rotation of the knob 411 in a first direction relative to the handle 404. FIG. 17 illustrates the flex nut 432 in a second axial position relative to the flex lead member 434, e.g., after rotation of the knob 411 in the first direction. As illustrated, the first axial position is distal to the second axial position. In some embodiments, rotation of the knob 411 in a first direction relative to the handle 404 can result in proximal translation of the flex nut 432, while rotation of the knob 411 in a second direction relative to the handle 404 (e.g., opposite the first direction) can result in distal translation of the flex nut 432. 16-17, the displacement nut 464 is shown in a third axial position, proximal to the first and second axial positions described with reference to Figures 14A and 14B. It should be understood that operation of the adjustment mechanism 424 is the same regardless of the axial position of the displacement nut 464 (e.g., the first axial position (Figure 14A), the second axial position (Figure 14B), etc.).

[0141] The knob 411 may be configured to rotate relative to the handle 404 to adjust the radius of curvature of the delivery shaft 406. When the knob 411 is rotated in the first direction 494, the gear assembly 472 may be configured to drive rotation of the flex lead member 434 relative to the handle 404. Specifically, rotation of the knob 411 drives rotation of a gear 440 coupled to the knob 411. The rod 438 is coupled to the gears 436, 440 such that the rod 438 and the gears 436, 440 co-rotate. In this manner, as the gear 440 rotates, the rod 438 and the gear 436 rotate as well. Furthermore, as described herein, rotation of the gear 436 causes rotation of the flex lead member 434 due to teeth on the outer surface 468 of the flex lead member 434 meshing with the teeth of the proximal gear 436, as shown in FIG. 11 . Due to the threaded connection between the flex lead member 434 and the flex nut 432, rotation of the flex lead member 434 drives axial displacement of the flex nut 432 relative to the flex lead member 434 and along the connector shaft 428. Because the proximal end of the pull wire 430 is fixedly coupled to the flex nut 432, the proximal end of the pull wire 430 is also translated axially (relative to the shaft 406). This allows the tension in the pull wire 430 to be increased as the flex nut 432 and pull wire 430 are advanced proximally, for example, to increase the radius of curvature of the distal end portion of the shaft 406.

[0142] In the first axial position, the distal surface of the flex nut 432 may be configured to abut the displacement nut 464 such that the flex nut 432 is disposed at the distal end of the flex lead member 434. As shown in FIG. 17 , after the knob 411 is rotated in the first direction 494, the flex nut 432 is displaced a distance D2 relative to the displacement nut 464 (and relative to the distal end of the flex lead member 434). The tension in the pull wire 430 and the radius of curvature of the shaft 406 depend on this distance D2. In some examples, the knob 411 may be rotated in the first direction 494 a number of turns, such as one or more turns, to fully bend the shaft 406 to its maximum radius of curvature. As described above, rotation of the knob 411 in a second direction relative to the handle 404 may be configured to result in translation of the flex nut 432 from a second axial position to a first axial position, for example, to decrease tension in the pull wire 430 and decrease the radius of curvature of the shaft 406.

[0143] As shown in FIGS. 18-21 , knob 411 (which, as described above, controls the operation of adjustment mechanism 424) may be operably coupled to indicator 416. Specifically, knob 411 (and thus adjustment mechanism 424) may be coupled to indicator 416 via gear reduction mechanism 500. Indicator 416 may be a rotatable indicator that rotates relative to end cap 490 (see, for example, FIG. 21 ). For example, end cap 490 may be configured with a reference mark such that the rotational position of a mark on indicator 416 relative to end cap 490 can indicate the amount of bend (or radius of curvature) of shaft 406. In some embodiments, end cap 490 may include a mark, and indicator 416 may be configured with a reference mark. In this manner, the reference mark may be configured to rotate relative to a mark on end cap 490 to indicate the amount of bend or radius of curvature of shaft 406.

[0144] Rotation of the knob 411 may drive rotation of both the adjustment mechanism 424 and the indicator 416. When the knob 411 rotates at a first speed, the gear reduction mechanism 500 may be configured to rotate the indicator 416 at a reduced speed. In this manner, the gear reduction mechanism 500 may be configured to allow the indicator 416 to rotate less than the knob 411 when the knob 411 rotates relative to the handle 404 to adjust the curvature of the shaft 406. As an example, even if multiple rotations of the knob 411 are required to fully bend the shaft 406, a half-turn of the indicator may indicate the full range of curvature of the shaft 406. This may allow the full range of curvature represented by markings on the indicator 416 to be visible to a user of the delivery device 400 from one direction, for example, without the need to torque or rotate the handle 404.

[0145] The gear reduction mechanism 500 may include one or more pulleys 502 and a belt 504. In some embodiments, as shown, the gear reduction mechanism 500 may include two pulleys 502 extending radially from a sun gear 506. The sun gear 506 may have teeth that mesh with the teeth of the gear 440. In this manner, rotation of the knob 411 relative to the handle 404 can drive rotation of the sun gear 506 (and thus the pulleys 502) via the gear 440.

[0146] In some embodiments, as shown, the sun gear 506 may be disposed about the distal end portion 488 of the base member 484. In particular, the sun gear 506 may be rotatable relative to the base member 484, which is fixed relative to the handle 404. The teeth of the sun gear 506 may be disposed at a proximal end of the sun gear 506, and the pulley 502 may extend radially from the distal end of the sun gear 506.

[0147] 18-20 , pulley 502 may be coupled to an inner surface 508 of belt 504. An outer surface of belt 504 includes teeth 510. Teeth 510 may be configured to selectively mesh with teeth 496 disposed on the inner surface of indicator 416. Specifically, indicator 416 may have a greater number of teeth 496 than the number of teeth 510 on belt 504.

[0148] The pulley 502 may be configured to urge the belt 504 radially outward toward the indicator 416 such that a subset of the teeth 510 on the belt 504 mesh with a subset of the teeth 496 on the indicator 416 at a given time. Specifically, as the sun gear 506 rotates via the knob 411, the pulley 502 similarly rotates, which selectively urges the teeth 510 on the belt 504 against the teeth 496 on the indicator 416, causing the indicator 416 to rotate at a slower rate. In some examples, for example, only the teeth 496, 510 adjacent the pulley 502 mesh, while the teeth 496, 510 not adjacent the pulley 502 do not mesh together. The difference in the number of teeth 496, 510 allows the gear reduction mechanism 500 to rotate the indicator 416 at a slower rate than the knob 411.

[0149] In some embodiments, the gear ratio of gear reduction mechanism 500 may be changed to, for example, allow indicator 416 to move more or less than half a rotation as shaft 406 is moved from the unbent configuration to the fully bent configuration. Specifically, the number of teeth 496 on indicator 416 and / or the number of teeth 510 on belt 504 may be changed such that indicator 416 is driven at different speeds resulting in different numbers of rotations of indicator 416 relative to handle 404 between the unbent and fully bent configurations.

[0150] 22-24, another exemplary delivery device 600 is shown and described. In some embodiments, delivery device 600 may have one or more of the features of delivery devices 200, 400 discussed above. In some embodiments, delivery device 600 may have a different configuration than delivery devices 200, 400.

[0151] For example, similar to delivery device 400, delivery device 600 can provide for manipulation of the radius of curvature of the shaft of delivery device 600 independently of axial displacement of the shaft relative to other components of the delivery device. For example, the shaft of delivery device 600 can be configured to retract relative to a prosthetic implant coupled to delivery device 600 via a shaft displacement mechanism without adjusting the radius of curvature of the shaft. Similarly, delivery device 600 can allow for adjustment of the curvature of the shaft via a shaft adjustment mechanism without changing the axial position of the shaft relative to the prosthetic implant.

[0152] Unlike delivery device 400, the first and second knobs of the delivery device, which control the bending and axial displacement of the shaft (discussed below), may be axially offset relative to one another. In other words, the first knob may be located at (or closer to) the distal end of the handle, the second knob may be located at (or closer to) the proximal end of the handle, and a central portion of the handle may be located between the first and second knobs. In some examples, the separation of the first and second knobs may allow the housing of delivery device 600 to have a narrower (low-profile) distal end portion that may allow the operator to grasp and handle the delivery device. Further details of delivery device 600 are described below.

[0153] Similar to delivery devices 200, 400, prosthetic valves (e.g., mechanically expandable prosthetic valves such as prosthetic valve 100 described herein, self-expandable prosthetic valves, balloon-expandable prosthetic valves, etc.) and / or prosthetic devices other than prosthetic valves, such as stents or grafts, may be configured to be removably coupled to delivery device 600.

[0154] The delivery device 600 in the illustrated embodiment generally includes a handle 604, a first elongated shaft 606 extending distally from the handle 604, and at least one expansion mechanism 608 extending distally through the first shaft 606 ( FIG. 24 ). Although not shown, a prosthetic device, such as a prosthetic heart valve, may be coupled to the expansion mechanism 608. The expansion mechanism 608 may include one of the expansion mechanisms described herein (e.g., any of the actuator assemblies described herein, a balloon for a balloon-expandable prosthesis, an inner shaft having a self-expandable prosthesis disposed on its outer surface, etc.), or other types of expansion mechanisms suitable for expandable prostheses. In some embodiments, the distal end portion of the shaft 606 may be sized to accommodate the prosthesis in its radially compressed delivery state (e.g., coupled to the expansion mechanism 608) during delivery of the prosthetic valve through the patient's vasculature.

[0155] The handle 604 of the delivery device 600 may include one or more control mechanisms (e.g., knobs or other actuation mechanisms) for controlling different components of the delivery device 600 for purposes of expanding and / or deploying the prosthetic valve. For example, in the illustrated embodiment, the handle 604 includes a first (flex) knob 611 and a second (shaft displacement) knob 612. Although not shown, the handle 604 may include one or more additional knobs, such as an actuation knob similar to the third knob 414 of FIG. 6 or a separate actuation knob. The first knob 611 may have one or more of the configurations of the first (flex) knob 411, and the second knob 612 may have one or more of the configurations of the second (shaft displacement) knob 412.

[0156] For example, the first knob 611 can be a rotatable knob configured to advance and / or position the delivery shaft 606 at or adjacent to a desired implantation location in a patient's body, where rotating the first knob 611 in a first direction (e.g., clockwise) relative to the handle 604 can increase the curvature of the shaft 606, and rotating the first knob 611 in a second direction (e.g., counterclockwise) relative to the handle 604 can decrease the curvature of the shaft 606. In other examples, the second knob 612 can be a rotatable knob configured to cause axial movement of the first shaft 606 in a distal and / or proximal direction relative to the prosthetic valve to deploy the prosthetic valve from the delivery shaft 606 as the prosthetic valve advances to a position at or adjacent to the desired implantation location, where rotating the second knob 612 in a first direction (e.g., clockwise) relative to the handle 604 can retract the shaft 606 proximally relative to the prosthetic valve, and rotating the second knob 612 in a second direction (e.g., counterclockwise) relative to the handle 604 can advance the shaft 606 distally.

[0157] In some examples, first knob 611 and / or second knob 612 can be actuated by sliding the knob, such as by pulling and / or pushing the knob. In some examples, delivery device 600 can be configured to include one or more indicator mechanisms similar to indicator 416 or other indicator mechanisms described above.

[0158] 22 , the first knob 611 is disposed at the distal end portion 618 of the handle 604. In embodiments that include an indicator mechanism, the indicator mechanism may be configured to be proximal or distal to the first knob 611. The second knob 612 is axially offset from the first knob 611 in the proximal direction (i.e., closer to the proximal end portion 620 of the handle 604). In embodiments that include a third knob, the third knob may be proximal to the second knob 612.

[0159] The handle 604 may also include an outer housing 622. As shown in FIG. 22 , in some embodiments, the first knob 611 may be distal to the housing 622 and may be uncovered or exposed from the housing 622. In some embodiments, the second knob 612 may be a wheel disposed within the housing 622, and the housing 622 may have an opening 613 through which a portion of the second knob 612 extends. In the illustrated embodiment, the second knob 612 may have a smooth surface. In some embodiments, the second knob 612 may have a coating (e.g., a silicone coating) to allow an operator to grip the wheel. In some embodiments, the second knob 612 may have a surface configuration, such as a textured surface or a surface with a plurality of grooves (similar to the first knob 611).

[0160] 24 , the handle 604 can include an adjustment mechanism 624 for adjusting the bend or curvature of the delivery shaft 606 and a displacement mechanism 626 for axially displacing the delivery shaft 606 relative to the expansion mechanism 608 disposed within the housing 622. In some embodiments, the adjustment mechanism 624 can be coupled to the displacement mechanism 626. Specifically, the delivery device 600 can include a connector shaft 628 for coupling the adjustment mechanism 624 and the displacement mechanism 626.

[0161] The adjustment mechanism 624 may be operably coupled to the first (flex) knob 611. In some examples, the distal end portion of the delivery shaft 606 may be steerable via the adjustment mechanism 624 based on rotation of the first knob 611 relative to the housing 622. For example, by rotating the knob 611, the curvature of the distal end portion of the delivery shaft 606 may be adjusted such that the distal end portion of the delivery shaft 606 can be oriented at a desired angle. Specifically, for implantation of a prosthesis (e.g., prosthetic valve 100, etc.), the distal end portion of the delivery shaft 606 may be oriented such that the prosthetic valve can be positioned at a target implantation location.

[0162] In addition to the knob 611, the adjustment mechanism 624 (also referred to herein as a “flex assembly”) may include a pull wire 630. The adjustment mechanism 624 may be configured to direct the distal end portion of the delivery shaft 606 via the knob 611 and the pull wire 630 by increasing or decreasing the tension in the pull wire 630. Specifically, the distal end of the pull wire 630 may be configured to be connected to the distal end portion of the delivery shaft 606. As the tension in the pull wire 630 changes, the curvature of the distal end portion of the delivery shaft 606 changes in response to the tension in the pull wire 630.

[0163] The adjustment mechanism 624 may also include a flex nut 632 and a flex lead member 634 for axially displacing the pull wire 630 relative to the handle 604. For example, the pull wire 630 may extend proximally within the handle 604, with the proximal end of the pull wire 630 connected to the flex nut 632. In some examples, the proximal end of the pull wire 630 may be connected to the flex nut 632 in a manner similar to how the pull wire 430 is connected to the flex nut 432 (i.e., via an attachment member (also referred to as a "wire wrap") that couples the pull wire 630 to the flex nut 632). In other examples, the proximal end of the pull wire 630 may be connected to the flex nut 632 in a manner different from how the pull wire 430 is connected to the flex nut 432 (e.g., via a fastener, adhesive, and / or other coupling means).

[0164] In some embodiments, delivery device 600 may also include one or more gear assemblies 672 for coupling knob 611 to other components of adjustment mechanism 624 disposed within handle 604. For example, each gear assembly 672 may include one or more first (or proximal) gears 636, one or more rods 638, and one or more second (or distal) gears 640.

[0165] As shown, gear assembly 672 may be configured to allow flex nut 632 and flex lead member 634 of adjustment mechanism 624 to be positioned (or move proximally) proximal to at least a portion of a component of displacement mechanism 626 within handle 604 (such as carriage 664 of displacement mechanism 626). Gear assembly 672 may be configured to allow adjustment mechanism 624 to be positioned generally proximal to displacement mechanism 626, even though knob 611 corresponding to adjustment mechanism 624 is distal to knob 612 corresponding to displacement mechanism 626. For example, rod 638 may be configured to generally extend at least a portion of the length of handle 604, and rod 638 may be configured to extend proximally from gear 640, through carriage 664 of displacement mechanism 626, and to at least gear 636, which may be coupled to flex lead member 634 of adjustment mechanism 624. Unlike the delivery device 400, the gear assembly 672 and the adjustment mechanism 624 may be configured to be positioned distally relative to the second (storage) knob 612 to enable axial separation of the first knob 611 and the second knob 612.

[0166] The flex nut 632 can be configured to be disposed around the connector shaft 628 such that the connector shaft 628 extends through an opening in the flex nut 632. The flex nut 632 can be configured to translate axially relative to the connector shaft 628 to adjust the tension of the pull wire 630. In some examples, rotation of the flex lead member 634 can result in axial translation of the flex nut 632 relative to the connector shaft 628. In some examples, the flex nut 632 can include one or more notches that can engage guides on the connector shaft 628 and can be configured to prevent rotational movement of the flex nut 632 relative to the connector shaft 628 during axial translation of the flex nut 632 along the connector shaft 628, similar to the notches 450 and guides 452 of the delivery device 400.

[0167] Additionally, the connector shaft 628 may include an axially extending slot in a region extending through the carriage 664 to allow the pull wire 630 to pass from a radially inward position of the connector shaft 628 to a radially outward position of the connector shaft 628. In some examples, as shown, the connector shaft 628 includes a central lumen 660 in which the expansion mechanism 408 is disposed and extends therethrough.

[0168] In some embodiments, the flex nut 632 includes external threads 633 that can mate with internal threads 635 of the flex lead member 634. Specifically, the flex lead member 634 has an inner surface defining a lumen and internal threads 635, and the external threads 633 of the flex nut 632 can be configured to threadably mate with the threads 635 on the inner surface of the lumen. In some embodiments, the flex nut 632 can be configured to translate axially within the flex lead member 634 along the threads 635 on the inner surface 662 and along the connector shaft 628 based on rotation of the first knob 611 relative to the handle 604.

[0169] In some embodiments, connector shaft 628 may be coupled to adjustment mechanism 624 and displacement mechanism 626. Specifically, a distal end of connector shaft 628 may be coupled to carriage 664 of displacement mechanism 626. In some embodiments, connector shaft 628 may be coupled to carriage 664 using a pin, as shown. In some embodiments, connector shaft 628 may be coupled to carriage 664 in other manners, such as with adhesive, a friction fit, or other coupling mechanism. At the proximal end of connector shaft 628, flange 654 may be coupled to rod 638, and flange 654 may be adjacent to the proximal end of flex lead member 634. In some embodiments, flex lead member 634 may be disposed around connector shaft 628, and rod 638 may extend through opening 656 in flange 654. Rod 638 may be rotatable relative to connector shaft 628 within opening 656. The proximal gear 636 may be disposed on the rod 638 and may be coupled (e.g., rotatably coupled) to an outer surface of the flex lead member 634. In some embodiments, the proximal gear 636 is fixedly coupled to the rod 638.

[0170] Flex lead member 634 may have an internally threaded surface 662 and an outer surface 668 including external teeth. As described above, flex nut 632 may have external threads that engage with the internal threads of flex lead member 634, as shown in FIG. 24 . The teeth on outer surface 668 may intermesh with teeth on proximal gear 636. As such, when proximal gear 636 is rotated by rotation of rod 638, flex lead member 634 may also rotate. The threaded connection between flex lead member 634 and flex nut 632 allows flex nut 632 (and therefore pull wire 630) to displace axially (along connector shaft 628 and within flex lead member 634) to change the tension in pull wire 630 and adjust the curvature or bend of the distal end portion of delivery shaft 606.

[0171] Knob 611 may be configured to be coupled to rod 638 via distal gear 640. Specifically, knob 611 may be configured with internal teeth 670 that mesh with (e.g., engage) with teeth on distal gear 640 to operably couple knob 611 to flex lead member 634 such that rotation of knob 611 drives or results in axial movement of flex nut 632.

[0172] In some embodiments, knob 611, distal gear 640, proximal gear 636, and rod 638 may have one or more of the features or variations described above with respect to knob 411, distal gear 440, proximal gear 436, and rod 438. For example, proximal gear 636 and distal gear 640 may be configured to couple to rod 638 such that gears 636, 640 are not permitted to rotate relative to rod 638. For example, rod 638 may be configured to have a shape (e.g., a D-shape) such that rod 638 mates with corresponding openings in gears 636, 640.

[0173] As described above, the displacement mechanism 626 may be configured to axially displace the delivery shaft 606 relative to the expansion mechanism 608 (e.g., to retract the delivery shaft 606 relative to a prosthetic heart valve coupled to the expansion mechanism 608). The displacement mechanism 626 may include a second knob 612 and a carriage 664 (also referred to in this disclosure as a “displacement nut” or “displacement member”). As described in more detail below, rotation of the knob 612 relative to the handle 604 may drive axial displacement of the carriage 664 (and the shaft 606 coupled thereto) relative to the handle 604 for operation of both the adjustment mechanism 624 and the displacement mechanism 626.

[0174] 22 and 23 , knob 612 may be a wheel having a portion exposed through opening 613 in housing 622. In some embodiments, the exposed portion of knob 612 is configured for a user to engage and rotate knob 612 relative to handle 604. Rotation of knob 612 is configured to axially displace one or more components of shaft displacement mechanism 626 (e.g., displacement nut 664) relative to knob 612 and housing 622. As shown in FIG. 24 , displacement nut 664, connector shaft 628, and one or more components of adjustment mechanism 624 may be disposed within a central portion of housing 622 (and handle 604) distal to knob 612.

[0175] In some embodiments, delivery device 600 may further include one or more gear assemblies 673 for coupling knob 612 to other components of displacement mechanism 626 disposed within handle 604. For example, each gear assembly 673 may include one or more gears 683 and one or more threaded rods 674 (also referred to as "lead screws"). As seen in FIG. 23 , teeth on an inner surface 678 of knob 612 may mesh (e.g., engage) with gears 683 coupled at the proximal end of threaded rod 674. In this embodiment, delivery device 600 may include two gear assemblies 673 (only one of which is shown in FIG. 23 ) each including two gears 683 and two corresponding threaded rods 674 coupled thereto. In other embodiments, delivery device 600 may include more or fewer gear assemblies.

[0176] In some embodiments, the threaded rod 674 extends into the flex knob 611 through corresponding axially aligned openings in the second knob 612, the flange 654, and a disk 677 disposed below the displacement nut 664 of the displacement mechanism 626. In some embodiments, the threaded rod 674 is threadedly engaged with an inner surface of an opening 675 in the displacement nut 664 such that rotation of the threaded rod 674 results in axial movement of the displacement nut 664 and retraction of the delivery shaft 606. Specifically, the displacement nut 664 can be configured to be coupled to the proximal end portion 682 of the delivery shaft 606 such that axial translation of the displacement nut 664 relative to the expansion mechanism 608 can retract the delivery shaft 606 relative to the expansion mechanism 608. In this manner, rotation of the knob 612 can control axial movement of the delivery shaft 606. In some embodiments, the proximal end portion 682 of the delivery shaft 606 may be configured to be coupled to an attachment member 679 disposed within a central opening 681 defined by an inner surface 678 of the second knob 612.

[0177] In some embodiments, delivery device 600 may further include a support rod 676 (also referred to as a “lead rod”) (similar to threaded rod 674) that extends through a corresponding opening in flange 654, through displacement nut 664 of displacement mechanism 626, and into flex knob 611. Support rod 676 may have a smooth outer surface and may provide additional support for displacement nut 664 during its axial translation. In the embodiment shown in FIG. 23 , delivery device 600 may include four support rods 676. In other embodiments, delivery device 600 may include more support rods 676. In other embodiments, delivery device 600 may include fewer support rods 676 or may eliminate support rods 676 altogether. In some embodiments, support rod 676 may be replaced with an additional threaded rod 674 coupled to an additional gear assembly 673.

[0178] As discussed above, the displacement nut 664 may be configured to be axially displaced, for example, as a result of rotation of the knob 612, as the nut 664 translates axially along the rod 638. In addition to the displacement nut 664 being configured to translate axially relative to the rod 638, the rod 638 may be configured to be rotatable within the opening in the displacement nut 664, for example, as a result of rotation of the first knob 611.

[0179] In some embodiments, the proximal end portion 682 of the delivery shaft 606 may also be coupled to the connector shaft 628. For example, the proximal end portion 682 of the delivery shaft 606 may be disposed within the lumen 660 of the connector shaft 628 and coupled thereto (e.g., with an adhesive). In such embodiments, the connector shaft 628 may be coupled to the displacement nut 664 (e.g., via a pin, fastener, and / or adhesive). In this manner, the relative axial positioning of the delivery shaft 606, the displacement nut 664, and the connector shaft 628 may be fixed such that axial displacement of one of these components results in axial displacement of the other components.

[0180] In some embodiments, delivery device 600 may further include an indicator mechanism coupled to first knob 611, such as, for example, an indicator similar to indicator 416 or another indicator.

[0181] In some embodiments, the operation of adjustment mechanism 624 to adjust the bend or curvature of delivery shaft 606 may be similar to the operation described above with respect to adjustment mechanism 424. In some embodiments, the operation of displacement mechanism 626 to axially displace delivery shaft 606 relative to expansion mechanism 608 disposed within housing 622 may be similar to the operation described above with respect to displacement mechanism 426. In other embodiments, the operation of adjustment mechanism 624 and / or displacement mechanism 626 may differ from the operation of adjustment mechanism 424 and displacement mechanism 426.

[0182] As described above, to adjust the bend or curvature of the distal end of delivery shaft 606, a user can engage and rotate knob 611 relative to handle 604. Teeth on the inner surface of knob 611 mesh with distal gear 640, such that rotation of knob 611 drives rotation of gear 640 and its associated rod 638. Rotation of rod 638, in turn, causes rotation of proximal gear 636, which meshes with teeth on the outer surface of flex lead member 634, thereby driving rotation of flex lead member 634. The threaded connection between the flex lead member 634 and the flex nut 632 allows the flex nut 632 (and the pull wire 630) to be displaced axially (along the connector shaft 628 and within the flex lead member 634) to change the tension in the pull wire 630 and adjust the curvature or bending of the distal end portion of the delivery shaft 606 without retracting the delivery shaft 606 relative to the expansion mechanism 608 and / or the prosthetic valve coupled at the distal end of the delivery shaft.

[0183] In some embodiments, knob 612 can be configured to be rotated relative to handle 604 to adjust the axial positioning of the distal end of delivery shaft 606 relative to expansion mechanism 608 and its associated prosthetic valve. For example, a user can engage an exposed portion of knob 612 and rotate the knob. When knob 612 is rotated in a first direction, gear assembly 673 drives the rotation of threaded rod 674, which threadably engages with a threaded interior surface of opening 675 in displacement nut 664. The threaded engagement and rotation of threaded rod 674 can drive displacement nut 664 axially, such that displacement nut 664 is translated (e.g., proximally) along rod 638. Due to the proximal end portion 682 of the delivery shaft 606 being fixedly coupled to the displacement nut 664, the shaft 606 also translates axially (e.g., proximally) relative to the prosthetic valve and expansion mechanism 608, which may be configured to allow the prosthetic valve (and in some embodiments, the expansion mechanism 608) to be unsheathed from the distal end of the shaft 606, for example, to allow radial expansion of the prosthetic valve coupled to the expansion mechanism 608.

[0184] Furthermore, due to the connection between the displacement nut 664 and the connector shaft 628, the connector shaft 628 and components of the adjustment mechanism 624 are also driven axially by the displacement nut 664. For example, rotation of the second knob 612 in a first direction may result in axial displacement (e.g., proximal displacement) of the connector shaft 628, the pull wire 630, the flex nut 632, the flex lead member 634, and the proximal gear 636. Thus, in some embodiments, rotation of the knob 612 axially displaces both the shaft 606 and the pull wire 630 (coupled to the distal end of the shaft 606) by the same amount. This allows the axial position of the shaft 606 to be adjusted relative to the expansion mechanism 608 (and the prosthetic valve) without changing the tension in the pull wire 630 and / or the radius of curvature of the distal end of the shaft 606. This may allow, for example, the prosthetic valve to be deployed from the distal end of the shaft 606 without changing the curvature of the shaft 606. In this manner, delivery device 600 can, among other things, improve the process of implanting a prosthetic device and / or reduce the time of the implantation procedure.

[0185] delivery technology To implant a prosthetic valve into the native aortic valve via a transfemoral delivery approach, the prosthetic valve is mounted in radial compression along the distal end portion of a delivery device. The prosthetic valve and the distal end portion of the delivery device are inserted into the femoral artery and advanced into and through the descending aorta, around the aortic arch, and through the ascending aorta. The prosthetic valve is positioned within the native aortic valve and radially expanded (e.g., by inflating a balloon, by actuating one or more actuators of the delivery device, or by deploying the prosthetic valve from a sheath to allow the prosthetic valve to self-expand). Alternatively, the prosthetic valve can be implanted within the native aortic valve via a transapical procedure, in which the prosthetic valve (on the distal end portion of the delivery device) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart, and the prosthetic valve is positioned within the native aortic valve. Alternatively, in a transaortic procedure, the prosthetic valve (on the distal end portion of the delivery device) is introduced into the aorta through a surgical incision in the ascending aorta, such as by a partial J sternotomy or a right parasternal minithoracotomy, and then advanced through the ascending aorta toward the native aortic valve.

[0186] To implant a prosthetic valve into the native mitral valve via a transseptal delivery approach, the prosthetic valve is mounted in radial compression along the distal end portion of a delivery device. The prosthetic valve and the distal end portion of the delivery device are inserted into the femoral vein and advanced into and through the inferior vena cava, into the right atrium, across the atrial septum (through a puncture made in the atrial septum), into the left atrium, and toward the native mitral valve. Alternatively, the prosthetic valve can be implanted into the native mitral valve via a transapical procedure, in which the prosthetic valve (on the distal end portion of the delivery device) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart, and the prosthetic valve is positioned within the native mitral valve.

[0187] To implant the prosthetic valve within the native tricuspid valve, the prosthetic valve is mounted in radial compression along the distal end portion of a delivery device. The prosthetic valve and distal end portion of the delivery device are inserted into the femoral vein and advanced into and through the inferior vena cava into the right atrium, where the prosthetic valve is positioned within the native tricuspid valve. A similar approach can be used to implant a prosthetic valve within the native pulmonary valve or pulmonary artery, except that the prosthetic valve is advanced through the native tricuspid valve into the right ventricle and toward the pulmonary valve / pulmonary artery.

[0188] Another delivery approach is the transatrial approach, in which the prosthetic valve (on the distal end portion of the delivery device) is inserted through an incision in the chest and through an incision made through the atrial wall (of the right or left atrium) to access either of the native heart valves. Atrial delivery can also be performed intravascularly, for example, from a pulmonary vein. Yet another delivery approach is the transventricular approach, in which the prosthetic valve (on the distal end portion of the delivery device) is inserted through an incision in the chest and through an incision made through the wall of the right ventricle (typically at or near the base of the heart) to implant the prosthetic valve within the native tricuspid valve, the native pulmonary valve, or the pulmonary artery.

[0189] In all delivery approaches, the delivery device can be advanced over a guidewire previously inserted into the patient's vasculature. Moreover, the disclosed delivery approaches are not intended to be limiting. Any of the prosthetic valves disclosed in this disclosure can be implanted using any of a variety of delivery procedures and any of a variety of delivery devices known in the art.

[0190] Any of the systems, devices, apparatus, etc. of the present disclosure can be sterilized (e.g., using heat, radiation, and / or chemicals, etc.) to ensure safety for patient use, and any of the methods herein can include sterilization of the associated system, device, apparatus, etc. as one of the method steps. Examples of radiation for use in sterilization include, but are not limited to, gamma radiation and ultraviolet light. Examples of chemicals for use in sterilization include, but are not limited to, ethylene oxide and hydrogen peroxide.

[0191] Treatment techniques, methods, procedures, etc., as described or suggested in this disclosure, or as described or suggested in the references incorporated herein, may be performed on live animals or may be performed on non-biological simulations such as cadavers, cadaver hearts, anthropomorphic ghosts, simulators (e.g., where a body part, tissue, etc. is simulated), etc.

[0192] Additional Examples of the Disclosed Technology In view of the implementations described above with respect to the disclosed subject matter, the present application discloses the following additional examples: It should be noted that one feature individually in an example, or two or more features in combination in that example, and optionally in combination with one or more features in one or more additional examples, are also further examples falling within the disclosure of the present application.

[0193] Example 1. A delivery device for a prosthetic valve, comprising: a handle body; a shaft displacement mechanism coupled to the handle body, the shaft displacement mechanism configured to axially displace a shaft relative to the handle body; a shaft adjustment mechanism coupled to the handle body, the shaft adjustment mechanism configured to adjust a curvature of the shaft, the shaft adjustment mechanism comprising a pull wire coupled to a distal end of the shaft; a first knob operably coupled to the shaft displacement mechanism and rotatable relative to the handle body, wherein rotating the first knob relative to the handle body simultaneously axially displaces the shaft and the pull wire relative to the handle body; and a second knob operably coupled to the shaft adjustment mechanism and rotatable relative to the handle body, wherein rotating the second knob relative to the handle body adjusts the radius of curvature of the shaft independently of the axial displacement of the shaft.

[0194] Example 2. A delivery device as described in any example of the present disclosure, particularly example 1, wherein rotating the first knob in a first direction relative to the handle body displaces the shaft and the pull wire proximally relative to the handle body.

[0195] Example 3. A delivery device as described in any example herein, particularly Example 1 or Example 2, wherein rotating the first knob in a second direction relative to the handle body displaces the shaft and the pull wire distally relative to the handle body.

[0196] Example 4. A delivery device described in any of the examples of the present disclosure, particularly any one of Examples 1-3, wherein rotating the second knob in a first direction relative to the handle body increases the radius of curvature of the shaft.

[0197] Example 5. A delivery device described in any of the examples of the present disclosure, particularly any one of Examples 1 to 4, wherein rotating the second knob in a second direction relative to the handle body decreases the radius of curvature of the shaft.

[0198] Example 6. A delivery device described in any of the examples of the present disclosure, particularly any one of Examples 1-5, wherein the shaft adjustment mechanism further comprises: a rotatable adjustment barrel having an inner lumen with a threaded inner surface; and an adjustment nut coupled to the pull wire and disposed within the inner lumen, the adjustment nut having a threaded outer surface coupled to the threaded inner surface of the adjustment barrel, the adjustment nut configured to translate axially relative to the adjustment barrel in response to rotation of the adjustment barrel.

[0199] Example 7. The delivery device of any example herein, particularly example 6, wherein the proximal end of the pull wire is coupled to the adjustment nut.

[0200] Example 8. A delivery device as described in any of the examples of the present disclosure, particularly example 7, wherein the adjustment nut comprises an attachment member extending radially from the body of the adjustment nut, and the proximal end of the pull wire is wrapped around the attachment member.

[0201] Example 9. A delivery device according to any of the examples herein, particularly any one of Examples 6-8, further comprising a connector shaft coupled to the adjustment mechanism and the shaft displacement mechanism.

[0202] Example 10. A delivery device as described in any of the examples of the present disclosure, particularly example 9, wherein the adjustment nut is circumferentially disposed around the connector shaft and is axially movable relative to the connector shaft.

[0203] Example 11. A delivery device as described in any of the examples of the present disclosure, particularly example 10, wherein the connector shaft comprises a guide protrusion extending along the axial length of the connector shaft, the adjusting nut comprises a notch aligned with the guide protrusion, and axial displacement of the adjusting nut relative to the connector shaft moves the notch along the guide protrusion.

[0204] Example 12. A delivery device described in any of the examples of the present disclosure, particularly any one of Examples 9-11, further comprising a gear system operatively connecting the shaft adjustment mechanism and the second knob.

[0205] Example 13. A delivery device as described in any example herein, particularly example 12, wherein the gear system comprises at least one distal gear having teeth that mesh with the internal teeth of the second knob, at least one proximal gear having teeth that mesh with the external teeth of the adjustment barrel, and at least one rod, and the at least one distal gear and the at least one proximal gear are coupled to the at least one rod.

[0206] Example 14. A delivery device described in any of the examples of the present disclosure, particularly any one of Examples 1 to 13, further comprising a rotatable indicator coupled to the shaft adjustment mechanism and configured to indicate the curvature of the shaft upon rotation of the second knob.

[0207] Example 15. A delivery device described in any of the examples of the present disclosure, particularly Example 14, further comprising a gear reduction mechanism operably connected between the shaft adjustment mechanism and the indicator, wherein rotation of the second knob relative to the handle body results in rotation of the indicator at a reduced speed based on the gear reduction mechanism.

[0208] Example 16. A delivery device according to any of the embodiments of the present disclosure, particularly Example 15, wherein the gear reduction mechanism is a harmonic drive (registered trademark, strain wave gearing) comprising one or more pulleys and a belt.

[0209] Example 17. A delivery device according to any of the examples of the present disclosure, particularly any one of Examples 1-16, further comprising a shaft, the shaft configured to house an artificial implant.

[0210] Example 18. A delivery device described in any of the examples of the present disclosure, particularly example 17, wherein the shaft displacement mechanism comprises a displacement nut connected to the shaft, the displacement nut being threadably connected to the first knob, and rotation of the first knob relative to the handle body results in axial displacement of the displacement nut and the shaft relative to the handle body.

[0211] Example 19. The delivery device of any example of the present disclosure, particularly Example 17 or Example 18, wherein the prosthetic implant comprises one of a prosthetic heart valve or a stent.

[0212] Example 20. A delivery device according to any of the examples of the present disclosure, particularly any one of Examples 17-19, wherein the prosthetic implant is self-expandable, balloon-expandable, and / or mechanically expandable.

[0213] Example 21. A delivery device described in any of the examples of the present disclosure, particularly any one of Examples 17-20, further comprising an expansion mechanism disposed within the shaft and coupled to the artificial implant, the expansion mechanism including one of at least one actuator assembly for mechanical expansion of the artificial implant, an inflatable balloon catheter for balloon expansion of the artificial implant, and an inner shaft for self-expansion of the artificial implant.

[0214] Example 22. A handle for a delivery device for a prosthetic valve, comprising: a handle body; a shaft displacement mechanism coupled to the handle body, the shaft displacement mechanism configured to axially displace a shaft relative to the handle body; a shaft adjustment mechanism connected to the handle body, the shaft adjustment mechanism configured to adjust the curvature of the shaft, the shaft adjustment mechanism comprising a pull wire coupled to the distal end of the shaft; a first knob operably coupled to the shaft displacement mechanism and rotatable relative to the handle body, wherein rotating the first knob relative to the handle body simultaneously displaces the shaft and the pull wire axially relative to the handle body; and a second knob operably coupled to the shaft adjustment mechanism and rotatable relative to the handle body, wherein rotating the second knob relative to the handle body adjusts the curvature of the shaft independently of the axial displacement of the shaft.

[0215] Example 23. A handle described in any of the embodiments of the present disclosure, particularly Example 22, wherein rotating the first knob in a first direction relative to the handle body displaces the shaft and the pull wire proximally relative to the handle body.

[0216] Example 24. A handle described in any of the embodiments of the present disclosure, particularly Example 22 or Example 23, wherein rotating the first knob in a second direction relative to the handle body displaces the shaft and the pull wire distally relative to the handle body.

[0217] Example 25. A handle described in any of the examples of the present disclosure, particularly any one of Examples 22 to 24, wherein rotating the second knob in a first direction relative to the handle body increases the radius of curvature of the shaft.

[0218] Example 26. A handle described in any of the embodiments of the present disclosure, particularly any one of Examples 22 to 25, wherein rotating the second knob in a second direction relative to the handle body reduces the radius of curvature of the shaft.

[0219] Example 27. A handle described in any of the embodiments of the present disclosure, particularly any one of Examples 22 to 26, wherein the shaft adjustment mechanism comprises a rotatable adjustment barrel having an inner cavity including a threaded inner surface, and an adjustment nut coupled to the pull wire and disposed within the inner cavity, the adjustment nut having a threaded outer surface coupled to the threaded inner surface of the adjustment barrel, and the adjustment nut configured to translate axially relative to the adjustment barrel in response to rotation of the adjustment barrel.

[0220] Example 28. A handle described in any of the embodiments of the present disclosure, particularly Example 27, wherein the proximal end of the pull wire is connected to the adjustment nut.

[0221] Example 29. A handle described in any of the embodiments of the present disclosure, particularly Example 28, wherein the adjustment nut has an attachment member extending radially from the body of the adjustment nut, and the proximal end of the pull wire is wound around the attachment member.

[0222] Example 30. A handle described in any of the examples of the present disclosure, particularly any one of Examples 27 to 29, further comprising a connector shaft connected to the adjustment mechanism and the shaft displacement mechanism.

[0223] Example 31. A handle described in any of the embodiments of the present disclosure, particularly Example 30, wherein the adjustment nut is circumferentially disposed around the connector shaft and is axially movable relative to the connector shaft.

[0224] Example 32. A handle described in any of the embodiments of the present disclosure, particularly Example 31, wherein the connector shaft has a guide protrusion extending along the axial length of the connector shaft, the adjusting nut has a notch aligned with the guide protrusion, and axial displacement of the adjusting nut relative to the connector shaft moves the notch along the guide protrusion.

[0225] Example 33. A handle described in any of the examples of the present disclosure, particularly any one of Examples 30 to 32, further comprising a gear system operably connecting the shaft adjustment mechanism and the second knob.

[0226] Example 34. A handle described in any of the examples herein, particularly example 33, wherein the gear system comprises at least one distal gear having teeth that mesh with the internal teeth of the second knob, at least one proximal gear having teeth that mesh with the external teeth of the adjustment barrel, and at least one rod, and the at least one distal gear and the at least one proximal gear are connected to the at least one rod.

[0227] Example 35. A handle described in any of the examples of the present disclosure, particularly any one of Examples 22 to 34, further comprising a rotatable indicator coupled to the shaft adjustment mechanism and configured to indicate the curvature of the shaft upon rotation of the second knob.

[0228] Example 36. A handle described in any of the embodiments of the present disclosure, particularly Example 35, further comprising a gear reduction mechanism operably connected between the shaft adjustment mechanism and the indicator, wherein rotation of the second knob relative to the handle body results in rotation of the indicator at a reduced speed based on the gear reduction mechanism.

[0229] Example 37. A handle described in any of the embodiments of the present disclosure, particularly Example 36, wherein the gear reduction mechanism is a harmonic drive comprising one or more pulleys and a belt.

[0230] Example 38. A delivery device for a prosthetic valve, comprising: a delivery shaft; an expansion mechanism disposed within the delivery shaft; a displacement nut coupled to a proximal end portion of the delivery shaft, the displacement nut configured to axially displace the delivery shaft relative to the expansion mechanism; a shaft adjustment mechanism comprising a pull wire coupled to a distal end portion of the delivery shaft, the shaft adjustment mechanism configured to adjust the curvature of the delivery shaft; a connector shaft coupled to the displacement nut and the shaft adjustment mechanism; a first knob operably coupled to the displacement nut and rotatable relative to the expansion mechanism, wherein rotating the first knob relative to the expansion mechanism simultaneously axially displaces the displacement nut, the delivery shaft, the pull wire, and the connector shaft relative to the expansion mechanism; and a second knob operably coupled to the shaft adjustment mechanism and rotatable relative to the expansion mechanism, wherein rotating the second knob relative to the expansion mechanism adjusts the tension of the pull wire independently of the axial displacement of the delivery shaft.

[0231] Example 39. A delivery device described in any of the embodiments of the present disclosure, particularly Example 38, wherein rotating the first knob in a first direction relative to the expansion mechanism displaces the displacement nut, the delivery shaft, the pull wire, and the connector shaft proximally relative to the expansion mechanism.

[0232] Example 40. A delivery device described in any of the embodiments of the present disclosure, particularly Example 38 or Example 39, wherein rotating the first knob in a second direction relative to the expansion mechanism displaces the displacement nut, the delivery shaft, the pull wire, and the connector shaft distally relative to the expansion mechanism.

[0233] Example 41. A delivery device described in any of the examples of the present disclosure, particularly any one of Examples 38 to 40, wherein rotating the second knob in a first direction relative to the expansion mechanism increases the tension in the pull wire.

[0234] Example 42. A delivery device described in any of the examples of the present disclosure, particularly any one of Examples 38 to 41, wherein rotating the second knob in a second direction relative to the expansion mechanism reduces the tension in the pull wire.

[0235] Example 43. A delivery device described in any of the examples of the present disclosure, particularly any one of Examples 38 to 42, wherein the proximal end of the connector shaft includes a flange and the distal end of the connector shaft is coupled to the displacement nut.

[0236] Example 44. A delivery device as described in any of the embodiments of the present disclosure, particularly Example 43, wherein the shaft adjustment mechanism further comprises: a rotatable adjustment barrel having an inner lumen including a threaded inner surface; and an adjustment nut coupled to the pull wire and positioned within the lumen, the adjustment nut having a threaded outer surface coupled to the threaded inner surface of the adjustment barrel, and configured to translate axially relative to the adjustment barrel in response to rotation of the adjustment barrel.

[0237] Example 45. A delivery device described in any of the examples of the present disclosure, particularly example 44, wherein the adjustment barrel is disposed circumferentially around the connector shaft and axially between the displacement nut and the flange.

[0238] Example 46. A delivery device described in any of the examples of the present disclosure, particularly any of Example 44 or Example 45, wherein the displacement nut is distal to the adjustment barrel and the adjustment nut.

[0239] Example 47. A delivery device described in any of the examples of the present disclosure, particularly any one of Examples 44 to 46, further comprising a gear system operably connecting the shaft adjustment mechanism and the second knob.

[0240] Example 48. A delivery device described in any of the embodiments of the present disclosure, particularly Example 47, wherein the gear system comprises at least one distal gear having teeth that mesh with the internal teeth of the second knob, at least one proximal gear having teeth that mesh with the external teeth of the adjustment barrel, and at least one rod, and the at least one distal gear and the at least one proximal gear are connected to the at least one rod.

[0241] Example 49. A delivery device described in any of the embodiments of the present disclosure, particularly Example 48, wherein the at least one rod extends through at least one opening in the displacement nut and at least one opening in the flange.

[0242] Example 50. A delivery device described in any of the examples of the present disclosure, particularly Example 48 or Example 49, wherein the at least one proximal gear extends the axial length of the adjustment barrel.

[0243] Example 51. A delivery device described in any of the examples of the present disclosure, particularly Example 48 or Example 49, wherein the axial length of the at least one proximal gear is shorter than the axial length of the adjustment barrel.

[0244] Example 52. A delivery device as described in any of the examples of the present disclosure, particularly example 51, further comprising a spacer coupled to the at least one rod, the spacer being distal to the flange and proximal to the displacement nut.

[0245] Example 53. A delivery device described in any of the examples of the present disclosure, particularly any one of Examples 38 to 52, further comprising a rotatable indicator coupled to the shaft adjustment mechanism and configured to indicate the curvature of the delivery shaft upon rotation of the second knob.

[0246] Example 54. A delivery device described in any of the embodiments of the present disclosure, particularly Example 53, further comprising a gear reduction mechanism operably connected between the shaft adjustment mechanism and the indicator, wherein rotation of the second knob relative to the expansion mechanism results in rotation of the indicator at a reduced speed based on the gear reduction mechanism.

[0247] Example 55. A delivery device described in any of the embodiments of the present disclosure, particularly Example 54, wherein the gear reduction mechanism is a harmonic drive comprising one or more pulleys and a belt.

[0248] Example 56. A delivery device described in any of the examples of the present disclosure, particularly any one of Examples 38 to 55, wherein the distal end portion of the delivery shaft is coupled to the connector shaft.

[0249] Example 57. A delivery device described in any of the examples of the present disclosure, particularly any one of Examples 38 to 56, wherein the connector shaft is coupled to the displacement nut via one or more pins.

[0250] Example 58. A delivery device described in any of the examples of the present disclosure, particularly any one of Examples 38 to 57, wherein the first knob is proximal to the second knob.

[0251] Example 59. A delivery device described in any of the examples of the present disclosure, particularly any one of Examples 38 to 58, wherein the adjustment nut has an attachment member extending radially from the body of the adjustment nut, and the proximal end of the pull wire is wound around the attachment member.

[0252] Example 60. A delivery device described in any of the examples of the present disclosure, particularly any one of Examples 38 to 59, wherein the adjustment nut is circumferentially disposed around the connector shaft and is axially movable relative to the connector shaft.

[0253] Example 61. A delivery device described in any of the embodiments of the present disclosure, particularly Example 60, wherein the connector shaft has a guide protrusion extending along the axial length of the connector shaft, the adjusting nut has a notch aligned with the guide protrusion, and axial displacement of the adjusting nut relative to the connector shaft moves the notch along the guide protrusion.

[0254] Example 62. A delivery device described in any of the examples of the present disclosure, particularly any one of Examples 38 to 61, wherein the delivery shaft is configured to accommodate an artificial implant.

[0255] Example 63. A delivery device according to any of the examples of the present disclosure, particularly example 62, wherein the prosthetic implant comprises one of a prosthetic heart valve or a stent.

[0256] Example 64. A delivery device according to any of the examples of the present disclosure, particularly any of Example 62 or Example 63, wherein the artificial implant is self-expandable, balloon-expandable, and / or mechanically expandable.

[0257] Example 65. A delivery device described in any of the examples of the present disclosure, particularly any one of Examples 62 to 64, wherein the expansion mechanism includes one of at least one actuator assembly for mechanical expansion of the artificial implant, an inflatable balloon catheter for balloon expansion of the artificial implant, and an inner shaft for self-expansion of the artificial implant.

[0258] Example 66. A delivery device for a prosthetic valve, comprising: a delivery shaft; at least one expansion mechanism disposed within the delivery shaft; a displacement member coupled to a proximal end portion of the delivery shaft, the displacement member configured to axially displace the delivery shaft relative to the expansion mechanism; a pull wire coupled to a distal end of the delivery shaft, the pull wire configured to adjust the curvature of the delivery shaft; an adjustment nut coupled to the pull wire, the adjustment nut having a threaded outer surface; and a rotatable adjustment barrel having a threaded inner surface coupled to the threaded outer surface of the adjustment nut, wherein rotation of the adjustment barrel relative to the expansion member results in axial displacement of the adjustment nut relative to the adjustment barrel.

[0259] Example 67. A delivery device as described in any of the embodiments of the present disclosure, particularly Example 66, further comprising a first knob operably coupled to the displacement member and rotatable relative to the expansion mechanism, wherein rotating the first knob relative to the expansion mechanism simultaneously axially displaces the displacement member and at least one of the delivery shaft, pull wire, adjustment nut, and adjustment barrel relative to the expansion mechanism.

[0260] Example 68. A delivery device described in any of the embodiments of the present disclosure, particularly Example 67, wherein rotating the first knob relative to the expansion mechanism simultaneously axially displaces the displacement member, the delivery shaft, the pull wire, the adjustment nut, and the adjustment barrel relative to the expansion mechanism.

[0261] Example 69. A delivery device described in any of the embodiments of the present disclosure, particularly Example 67 or Example 68, wherein rotating a first knob in a first direction relative to the expansion mechanism displaces the displacement member in a proximal direction relative to the expansion mechanism.

[0262] Example 70. A delivery device described in any of the embodiments of the present disclosure, particularly any one of Examples 67 to 69, wherein rotating the first knob in a second direction relative to the expansion mechanism displaces the displacement member distally relative to the expansion mechanism.

[0263] Example 71. A delivery device described in any of the examples of the present disclosure, particularly any one of Examples 66 to 70, further comprising a second knob operably coupled to the adjustment barrel and rotatable relative to the expansion mechanism, wherein rotating the second knob relative to the expansion mechanism results in rotation of the adjustment barrel.

[0264] Example 72. A delivery device described in any of the examples herein, particularly example 71, wherein rotation of the adjustment barrel results in adjustment of the tension of the pull wire independent of axial displacement of the delivery shaft.

[0265] Example 73. A delivery device described in any of the examples of the present disclosure, particularly any of Example 71 or Example 72, wherein rotating the second knob in a first direction relative to the expansion mechanism increases the tension in the pull wire.

[0266] Example 74. A delivery device described in any of the embodiments of the present disclosure, particularly any one of Examples 71 to 73, wherein rotating the second knob in a second direction relative to the expansion mechanism reduces the tension in the pull wire.

[0267] Example 75. A delivery device described in any of the examples of the present disclosure, particularly any one of Examples 71 to 74, further comprising a gear system operatively connecting the adjustment barrel and the second knob.

[0268] Example 76. A delivery device described in any example herein, particularly example 75, wherein the gear system comprises at least one distal gear having teeth that mesh with the internal teeth of the second knob, at least one proximal gear having teeth that mesh with the external teeth of the adjustment barrel, and at least one rod, and the at least one distal gear and the at least one proximal gear are coupled to the at least one rod.

[0269] Example 77. A delivery device described in any of the embodiments of the present disclosure, particularly example 76, wherein the at least one proximal gear extends the axial length of the adjustment barrel.

[0270] Example 78. A delivery device described in any of the embodiments of the present disclosure, particularly Example 76, wherein the axial length of the at least one proximal gear is shorter than the axial length of the adjustment barrel.

[0271] Example 79. A delivery device described in any of the embodiments of the present disclosure, particularly any one of Examples 66 to 78, wherein the displacement member is distal to the adjustment barrel and the adjustment nut.

[0272] Example 80. A delivery device described in any of the embodiments of the present disclosure, particularly any one of Examples 66 to 79, further comprising a connector shaft connected to the displacement member and the shaft adjustment mechanism.

[0273] Example 81. A delivery device described in any of the embodiments of the present disclosure, particularly Example 80, wherein the proximal end of the connector shaft includes a flange and the distal end of the connector shaft is coupled to the displacement member.

[0274] Example 82. A delivery device described in any of the embodiments of the present disclosure, particularly Example 81, wherein the adjustment barrel is arranged circumferentially around the connector shaft and axially between the displacement member and the flange.

[0275] Example 83. A delivery device described in any of the embodiments of the present disclosure, particularly any one of Examples 80 to 82, wherein the adjustment member is circumferentially arranged around the connector shaft and is axially movable relative to the connector shaft.

[0276] Example 84. A delivery device described in any of the embodiments of the present disclosure, particularly Example 83, wherein the connector shaft has a guide protrusion extending along the axial length of the connector shaft, the adjustment member has a notch aligned with the guide protrusion, and axial displacement of the adjustment member relative to the connector shaft moves the notch along the guide protrusion.

[0277] Example 85. A delivery device described in any of the examples of the present disclosure, particularly any one of Examples 66 to 84, further comprising a rotatable indicator operably coupled to the second knob and configured to indicate the curvature of the delivery shaft when the second knob is rotated.

[0278] Example 86. A delivery device described in any of the embodiments of the present disclosure, particularly Example 85, further comprising a gear reduction mechanism operably coupled between the second knob and the indicator, wherein rotation of the second knob relative to the expansion mechanism results in rotation of the indicator at a reduced speed based on the gear reduction mechanism.

[0279] Example 87. A delivery device described in any of the embodiments of the present disclosure, particularly Example 86, wherein the gear reduction mechanism is a harmonic drive comprising one or more pulleys and a belt.

[0280] Example 88. A delivery device described in any of the examples of the present disclosure, particularly any one of Examples 66 to 87, wherein the distal end portion of the delivery shaft is coupled to the connector shaft.

[0281] Example 89. A delivery device described in any of the examples of the present disclosure, particularly any one of Examples 66 to 88, wherein the connector shaft is coupled to the displacement member via one or more pins.

[0282] Example 90. A delivery device described in any of the examples of the present disclosure, particularly any one of Examples 66 to 89, wherein the first knob is proximal to the second knob.

[0283] Example 91. A delivery device described in any of the embodiments of the present disclosure, particularly any one of Examples 66 to 90, wherein the adjustment member includes a radial protrusion and the proximal end of the pull wire is wound around the radial protrusion.

[0284] Example 92. A delivery device described in any of the examples of the present disclosure, particularly any one of Examples 66 to 91, wherein the delivery shaft is configured to accommodate an artificial implant.

[0285] Example 93. The delivery device of any example of the present disclosure, particularly example 92, wherein the prosthetic implant comprises one of a prosthetic heart valve or a stent.

[0286] Example 94. A delivery device according to any of the examples of the present disclosure, particularly any of Example 92 or Example 93, wherein the artificial implant is self-expandable, balloon-expandable, and / or mechanically expandable.

[0287] Example 95. A delivery device described in any of the examples of the present disclosure, particularly any one of Examples 92 to 94, wherein the expansion mechanism includes one of at least one actuator assembly for mechanical expansion of the artificial implant, an inflatable balloon catheter for balloon expansion of the artificial implant, and an inner shaft for self-expansion of the artificial implant.

[0288] Example 96. A method comprising sterilizing the delivery device of any one of Examples 1-21.

[0289] Example 97. A method comprising sterilizing the handle of any one of Examples 22-37.

[0290] Example 98. A method comprising sterilizing a delivery device comprising a handle and a shaft coupled to the handle according to any one of Examples 22-37.

[0291] Example 99. A method comprising sterilizing the delivery device of any one of Examples 38-95.

[0292] Example 100. A method for implanting an artificial implant, comprising: adjusting the curvature of a delivery shaft holding the artificial implant relative to a longitudinal axis of a handle coupled to the delivery shaft; and displacing the delivery shaft relative to the artificial implant, wherein the curvature is maintained during displacement.

[0293] Example 101. A method according to any of the embodiments of the present disclosure, particularly example 100, wherein adjusting the curvature includes rotating a first knob relative to the handle.

[0294] Example 102. The method according to any of the embodiments of the present disclosure, particularly example 100 or example 101, wherein displacing the delivery shaft relative to the artificial implant comprises rotating a second knob relative to the handle.

[0295] Example 103. A delivery device described in any of the examples of the present disclosure, particularly any one of Examples 1 to 17, wherein the shaft displacement mechanism comprises a displacement nut coupled to the shaft, the displacement nut being threaded onto one or more threaded rods, each of the one or more threaded rods being coupled to a gear that meshes with an inner surface of the first knob, and rotation of the first knob relative to the handle body results in axial displacement of the displacement nut and the shaft relative to the handle body.

[0296] Example 104. A delivery device described in any of the examples of the present disclosure, particularly example 103, wherein the first knob is proximal to the second knob and the displacement nut, and the first knob and the second knob are axially separated on the handle body.

[0297] Example 105. A delivery device described in any of the examples of the present disclosure, particularly any one of Examples 38 to 65, wherein the displacement nut is threaded onto one or more threaded rods, each of the one or more threaded rods is connected to a gear that meshes with the inner surface of the first knob, and rotation of the first knob results in axial movement of the displacement nut and the shaft.

[0298] Example 106. A delivery device described in any of the examples of the present disclosure, particularly example 105, wherein the first knob is proximal to the second knob and the displacement nut, and the first knob and the second knob are axially separated on the handle of the delivery device.

[0299] Unless otherwise stated, features described herein with respect to any example may be combined with other features described with respect to any one or more other examples. For example, any one or more features of one delivery device may be combined with any one or more features of another delivery device.

[0300] In view of the many possible ways in which the principles of the present disclosure may be applied, it will be recognized that the illustrated configurations are illustrative examples of the disclosed technology and should not be taken as limiting the scope of the present disclosure or the claims that follow. Rather, the scope of claimed subject matter is defined by the following claims and their equivalents.

Claims

1. 1. A delivery device for a prosthetic valve, comprising: The handle body and a shaft displacement mechanism coupled to the handle body, the shaft displacement mechanism configured to axially displace a shaft relative to the handle body; a shaft adjustment mechanism coupled to the handle body, the shaft adjustment mechanism configured to adjust the curvature of the shaft, the shaft adjustment mechanism including a pull wire coupled to a distal end of the shaft; a first knob operably coupled to the shaft displacement mechanism and rotatable relative to the handle body, wherein rotating the first knob relative to the handle body simultaneously axially displaces the shaft and the pull wire relative to the handle body; and a second knob operably coupled to the shaft adjustment mechanism and rotatable relative to the handle body, wherein rotating the second knob relative to the handle body adjusts the radius of curvature of the shaft independent of axial displacement of the shaft.

2. The delivery device of claim 1 , wherein rotating the first knob in a first direction relative to the handle body displaces the shaft and the pull wire proximally relative to the handle body.

3. 3. The delivery device of claim 1, wherein rotating the first knob in a second direction relative to the handle body displaces the shaft and the pull wire distally relative to the handle body.

4. The delivery device of any one of claims 1 to 3, wherein rotating the second knob relative to the handle body in a first direction increases the radius of curvature of the shaft.

5. The delivery device of any one of claims 1 to 4, wherein rotating the second knob in a second direction relative to the handle body decreases the radius of curvature of the shaft.

6. The shaft adjustment mechanism is a rotatable adjustment barrel having a bore with a threaded inner surface; 6. The delivery device of claim 1, further comprising: an adjustment nut coupled to the pull wire and disposed within the lumen, the adjustment nut having a threaded outer surface coupled to the threaded inner surface of the adjustment barrel, the adjustment nut configured to translate axially relative to the adjustment barrel in response to rotation of the adjustment barrel.

7. The delivery device of claim 6 , wherein a proximal end of the pull wire is coupled to the adjustment nut.

8. The delivery device of claim 7 , wherein the adjustment nut includes an attachment member extending radially from a body of the adjustment nut, the proximal end of the pull wire being wrapped around the attachment member.

9. The delivery device of any one of claims 6 to 8, further comprising a connector shaft coupled to the adjustment mechanism and the shaft displacement mechanism.

10. The delivery device of claim 9 , wherein the adjustment nut is circumferentially disposed around the connector shaft and is axially movable relative to the connector shaft.

11. 11. The delivery device of claim 10, wherein the connector shaft includes a guide protrusion extending along an axial length of the connector shaft, and the adjusting nut includes a notch aligned with the guide protrusion, such that axial displacement of the adjusting nut relative to the connector shaft moves the notch along the guide protrusion.

12. The delivery device of any one of claims 9 to 11, further comprising a gear system operatively connecting the shaft adjustment mechanism and the second knob.

13. said gear system comprising: at least one distal gear having teeth that mesh with the internal teeth of the second knob; at least one proximal gear having teeth that mesh with the external teeth of the adjustment barrel; 13. The delivery device of claim 12, comprising: at least one rod, wherein the at least one distal gear and the at least one proximal gear are coupled to the at least one rod.

14. 14. The delivery device of claim 1, further comprising a rotatable indicator coupled to the shaft adjustment mechanism and configured to indicate the curvature of the shaft upon rotation of the second knob.

15. 15. The delivery device of claim 14, further comprising a gear reduction mechanism operably coupled between the shaft adjustment mechanism and the indicator, wherein rotation of the second knob relative to the handle body causes rotation of the indicator at a reduced speed based on the gear reduction mechanism.

16. 16. The delivery device of claim 15, wherein the gear reduction mechanism is a harmonic drive comprising one or more pulleys and a belt.

17. The delivery device of any one of claims 1 to 16, further comprising the shaft, the shaft configured to house an artificial implant.

18. 18. The delivery device of claim 17, wherein the shaft displacement mechanism comprises a displacement nut coupled to the shaft, the displacement nut threadably coupled to the first knob, and wherein rotation of the first knob relative to the handle body results in axial displacement of the displacement nut and the shaft relative to the handle body.

19. 19. The delivery device of claim 17 or claim 18, wherein the prosthetic implant comprises one of a prosthetic heart valve or a stent.

20. The delivery device of any one of claims 17 to 19, wherein the artificial implant is self-expandable, balloon-expandable, and / or mechanically expandable.

21. 21. The delivery device of any one of claims 17 to 20, further comprising an expansion mechanism disposed within the shaft and coupled to the artificial implant, the expansion mechanism comprising one of: at least one actuator assembly for mechanical expansion of the artificial implant; an inflatable balloon catheter for balloon expansion of the artificial implant; and an inner shaft for self-expansion of the artificial implant.

22. 18. The delivery device of any one of claims 1-17, wherein the shaft displacement mechanism comprises a displacement nut coupled to the shaft, the displacement nut threadedly engaged with one or more threaded rods, each of the one or more threaded rods coupled to a gear that meshes with an interior surface of the first knob, and wherein rotation of the first knob relative to the handle body results in axial displacement of the displacement nut and the shaft relative to the handle body.

23. 23. The delivery device of claim 22, wherein the first knob is proximal to the second knob and the displacement nut, and the first knob and the second knob are axially separated on the handle body.

24. 1. A delivery device for a prosthetic valve, comprising: a delivery shaft; an expansion mechanism disposed within the delivery shaft; a displacement nut coupled to a proximal end portion of the delivery shaft, the displacement nut configured to axially displace the delivery shaft relative to the expansion mechanism; a shaft adjustment mechanism comprising a pull wire coupled to a distal end portion of the delivery shaft, the shaft adjustment mechanism configured to adjust the curvature of the delivery shaft; a connector shaft coupled to the displacement nut and the shaft adjustment mechanism; a first knob operably coupled to the displacement nut and rotatable relative to the expansion mechanism, wherein rotating the first knob relative to the expansion mechanism simultaneously axially displaces the displacement nut, the delivery shaft, the pull wire, and the connector shaft relative to the expansion mechanism; and a second knob operably coupled to the shaft adjustment mechanism and rotatable relative to the expansion mechanism, wherein rotating the second knob relative to the expansion mechanism adjusts tension in the pull wire independent of axial displacement of the delivery shaft.

25. 25. The delivery device of claim 24, wherein rotating the first knob in a first direction relative to the expansion mechanism displaces the displacement nut, the delivery shaft, the pull wire, and the connector shaft proximally relative to the expansion mechanism.

26. 26. The delivery device of claim 24 or claim 25, wherein rotating the first knob in a second direction relative to the expansion mechanism displaces the displacement nut, the delivery shaft, the pull wire, and the connector shaft distally relative to the expansion mechanism.

27. The delivery device of any one of claims 24 to 26, wherein rotating the second knob in a first direction relative to the expansion mechanism increases the tension in the pull wire.

28. 28. The delivery device of any one of claims 24 to 27, wherein rotating the second knob in a second direction relative to the expansion mechanism decreases the tension in the pull wire.

29. The delivery device of any one of claims 24 to 28, wherein a proximal end of the connector shaft includes a flange and a distal end of the connector shaft is coupled to the displacement nut.

30. The shaft adjustment mechanism is a rotatable adjustment barrel having a bore including a threaded inner surface; 30. The delivery device of claim 29, further comprising: an adjustment nut coupled to the pull wire and disposed within the lumen, the adjustment nut having a threaded outer surface coupled to the threaded inner surface of the adjustment barrel and configured to translate axially relative to the adjustment barrel in response to rotation of the adjustment barrel.

31. 31. The delivery device of claim 30, wherein the adjustment barrel is disposed circumferentially around the connector shaft and axially between the displacement nut and the flange.

32. 32. The delivery device of claim 30 or claim 31, wherein the displacement nut is distal to the adjustment barrel and the adjustment nut.

33. The delivery device of any one of claims 30 to 32, further comprising a gear system operatively connecting the shaft adjustment mechanism and the second knob.

34. said gear system comprising: at least one distal gear having teeth that mesh with the internal teeth of the second knob; at least one proximal gear having teeth that mesh with the external teeth of the adjustment barrel; 34. The delivery device of claim 33, comprising: at least one rod, wherein the at least one distal gear and the at least one proximal gear are coupled to the at least one rod.

35. 35. The delivery device of claim 34, wherein the at least one rod extends through at least one opening in the displacement nut and at least one opening in the flange.

36. 36. The delivery device of claim 34 or claim 35, wherein the at least one proximal gear extends the axial length of the adjustment barrel.

37. 36. The delivery device of claim 34 or claim 35, wherein the axial length of the at least one proximal gear is shorter than the axial length of the adjustment barrel.

38. 38. The delivery device of claim 37, further comprising a spacer coupled to the at least one rod, the spacer distal to the flange and proximal to the displacement nut.

39. 39. The delivery device of any one of claims 24 to 38, further comprising a rotatable indicator coupled to the shaft adjustment mechanism and configured to indicate the curvature of the delivery shaft upon rotation of the second knob.

40. 40. The delivery device of claim 39, further comprising a gear reduction mechanism operably coupled between the shaft adjustment mechanism and the indicator, wherein rotation of the second knob relative to the expansion mechanism results in rotation of the indicator at a reduced speed based on the gear reduction mechanism.

41. 41. The delivery device of claim 40, wherein the gear reduction mechanism is a harmonic drive comprising one or more pulleys and a belt.

42. The delivery device of any one of claims 24 to 41, wherein the distal end portion of the delivery shaft is coupled to the connector shaft.

43. The delivery device of any one of claims 24 to 42, wherein the connector shaft is coupled to the displacement nut via one or more pins.

44. The delivery device of any one of claims 24 to 43, wherein the first knob is proximal to the second knob.

45. 45. The delivery device of any one of claims 24 to 44, wherein the adjustment nut includes an attachment member extending radially from a body of the adjustment nut, the proximal end of the pull wire being wrapped around the attachment member.

46. 46. ​​The delivery device of any one of claims 24 to 45, wherein the adjustment nut is circumferentially disposed around the connector shaft and is axially movable relative to the connector shaft.

47. 47. The delivery device of claim 46, wherein the connector shaft includes a guide protrusion extending along an axial length of the connector shaft, and the adjusting nut includes a notch aligned with the guide protrusion, such that axial displacement of the adjusting nut relative to the connector shaft moves the notch along the guide protrusion.

48. 48. The delivery device of any one of claims 24 to 47, wherein the delivery shaft is configured to house a prosthetic implant.

49. 49. The delivery device of claim 48, wherein the prosthetic implant comprises one of a prosthetic heart valve or a stent.

50. 50. A delivery device according to claim 48 or claim 49, wherein the artificial implant is self-expandable, balloon-expandable, and / or mechanically expandable.

51. 51. The delivery device of any one of claims 48 to 50, wherein the expansion mechanism comprises one of at least one actuator assembly for mechanical expansion of the artificial implant, an inflatable balloon catheter for balloon expansion of the artificial implant, and an inner shaft for self-expansion of the artificial implant.

52. 52. The delivery device of any one of claims 24-51, wherein the displacement nut is threaded onto one or more threaded rods, each of the one or more threaded rods is coupled to a gear that meshes with an inner surface of the first knob, and wherein rotation of the first knob results in axial movement of the displacement nut and the shaft.

53. 53. The delivery device of claim 52, wherein the first knob is proximal to the second knob and the displacement nut, and the first knob and the second knob are axially separated on the handle of the delivery device.

Images