Delivery device and method for implanting a prosthetic heart valve

Abstract

The delivery device for the prosthetic heart valve includes a handle having at least one rotatable knob. A pull body is disposed within the cavity and operably coupled to the knob such that rotation of the knob results in movement of the pull body within the cavity along a longitudinal axis of the handle. An actuation assembly capable of releasably engaging with an actuator of the prosthetic heart valve includes a sleeve member. An end portion of the sleeve member is disposed within the cavity of the handle and coupled to the pull body such that movement of the pull body by rotation of the knob axially displaces the sleeve member relative to the handle. The sleeve member may be axially displaced to release the actuation assembly from engagement with the actuator of the prosthetic heart valve.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 63 / 292,285, filed December 21, 2021, which is incorporated by reference in its entirety.

[0002] The present invention relates to implantable prosthetic devices, such as prosthetic heart valves, and to delivery devices and methods for implanting prosthetic heart valves. [Background technology]

[0003] The human heart can suffer from a variety of valvular diseases that can cause serious malfunction of the heart, ultimately necessitating repair of the native valve or replacement of the native valve with an artificial valve. Numerous repair devices (e.g., stents) and artificial valves are known, as are numerous methods for implanting such devices and valves in humans. Percutaneous and minimally invasive surgical approaches are used in a variety of procedures to deliver artificial medical devices to locations within the body that are not easily accessible by surgery or where access without surgery is desirable.

[0004] In one embodiment, the prosthetic heart valve may be mounted in a crimped state on the distal end of a delivery device and advanced through the patient's vascular system (e.g., through the femoral artery and the aorta) to reach the implantation site within the heart. The prosthetic heart valve is then expanded to its functional size, for example, by inflating a balloon to which the prosthetic heart valve is mounted, or by activating a mechanical actuator that applies an expansive force to the prosthetic heart valve, or by deploying the prosthetic heart valve from a sheath of the delivery device, allowing it to self-expand to its functional size.

[0005] A prosthetic heart valve that relies on a mechanical actuator for expansion may be referred to as a "mechanically expandable" prosthetic heart valve. A mechanically expandable prosthetic heart valve may provide one or more advantages over a self-expandable prosthetic heart valve and over a balloon-expandable prosthetic heart valve. For example, a mechanically expandable prosthetic heart valve may be expanded to a variety of diameters. A mechanically expandable prosthetic heart valve may also be compressed (e.g., for repositioning and / or for retrieval) after the initial expansion. However, some known devices and methods may cause rotation or movement of the prosthetic valve during expansion.

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

[0007] Described herein are delivery devices and methods for implanting a prosthetic heart valve. The disclosed delivery devices and methods can, for example, reduce the difficulty and / or time required to implant a prosthetic heart valve. The disclosed delivery devices are relatively simple and easy to use, and include various safeguards that can help ensure that the prosthetic heart valve is safely and securely implanted.

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

[0009] In some examples, a delivery device for a prosthetic heart valve may include a handle body, a pull body, an actuation assembly, and a knob. The handle has a cavity and defines a longitudinal axis. The pull body is disposed within the cavity and is movable within the cavity and along the longitudinal axis. The actuation assembly includes a sleeve member having an end portion disposed within the cavity and coupled to the pull body such that movement of the pull body along the longitudinal axis axially displaces the sleeve member relative to the handle body. The knob is rotatably mounted on the handle body and operably coupled to the pull body such that rotation of the knob relative to the handle body moves the pull body within the cavity and along the longitudinal axis.

[0010] In some examples, a delivery device for a prosthetic heart valve may include a handle body, an actuator driver, a sleeve member, and a pull body. The handle body has a first end, a second end, a cavity between the first end and the second end, and a longitudinal axis extending through the first end, the cavity, and the second end. The actuator driver has a first driver end portion disposed within the cavity, a second driver end portion disposed outside the cavity, and a first axial axis extending through the first and second driver end portions. The sleeve member is operably coupled to the actuator driver. The sleeve member has a first sleeve end portion disposed within the cavity, a second sleeve end portion disposed outside the cavity, and a second axial axis extending through the first and second sleeve end portions, the second axial axis being parallel to the first axial axis. The pull body is disposed within the cavity and coupled to the first sleeve end portion. The pull body is movable along the longitudinal axis such that movement of the pull body axially displaces the sleeve member relative to the handle body.

[0011] In some embodiments, the delivery device comprises one or more of the components listed in Examples 1-40 herein.

[0012] The assembly may include a prosthetic heart valve and a delivery device.

[0013] In some examples, the delivery assembly may include a prosthetic heart valve, a handle, an actuator driver, a sleeve member, a pull body, and a knob. The prosthetic heart valve includes a frame and at least one actuator coupled to the frame and operable to move the frame between a radially expanded configuration and a radially compressed configuration. The handle includes a handle body having a cavity and defining a longitudinal axis. The actuator driver is configured to releasably engage at least one actuator of the prosthetic heart valve. The sleeve member is operably coupled to the actuator driver and is movable between a first position in which the actuator driver is held in engagement with the at least one actuator and a second position in which the actuator driver is disengaged from the at least one actuator. The pull body is disposed within the cavity and coupled to an end portion of the sleeve member, the pull body being movable along the longitudinal axis such that movement of the pull body axially displaces the sleeve member between the first position and the second position. The knob is rotatably mounted on the handle body and operably coupled to the pull body such that rotation of the knob relative to the handle body moves the pull body along the longitudinal axis.

[0014] In some embodiments, the delivery assembly includes one or more of the components listed in Examples 41-48 herein.

[0015] The implantation method may include coupling the prosthetic heart valve to a delivery device, delivering the prosthetic heart valve to an implantation location with the delivery device, and expanding the prosthetic heart valve to a functional size or working diameter using the delivery device.

[0016] In some examples, a method of implanting a prosthetic heart valve may include engaging an end portion of an actuator driver coupled to a handle with an end portion of an actuator coupled to a frame of the prosthetic heart valve, moving a pull body in a first direction along a longitudinal axis of the handle to extend an end portion of a sleeve member coupled to the pull body over the engaged end portions of the actuator driver and the actuator, delivering the prosthetic heart valve to an implantation location, radially expanding the prosthetic heart valve to a functional size, moving the pull body in a second direction along the longitudinal axis of the handle opposite the first direction to withdraw the end portion of the sleeve member from the engaged end portion of the actuator driver and the actuator, and releasing the end portion of the actuator driver from the end portion of the actuator.

[0017] In some embodiments, the method includes one or more of the acts recited in Examples 49-50 herein.

[0018] The various innovations of the present disclosure can be used in combination or separately. This Summary is provided to introduce in a simplified form a selection of concepts that are further described in the Detailed Description below. This Summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. These and other objects, features, and advantages of the present disclosure will become more apparent from the Detailed Description that follows, from the claims, and from the accompanying drawings. [Brief description of the drawings]

[0019] [Figure 1] FIG. 1 is a perspective view of a prosthetic heart valve. [Figure 2A] FIG. 2A is a perspective view of the prosthetic heart valve in a radially expanded configuration with the valvular structure removed, showing the actuator head at the outflow end of the frame. [Figure 2B]FIG. 2B is a perspective view of the prosthetic heart valve in a radially expanded configuration, showing the actuator head at the inflow end of the frame. [Diagram 3] FIG. 3 is a detailed view of the actuator of the prosthetic heart valve. [Figure 4A] FIG. 4A is a side view of the proximal end portion of the delivery device. [Figure 4B] FIG. 4B is a side view of a distal end portion of a delivery device having a prosthetic heart valve coupled thereto, in a radially expanded configuration. [Diagram 5] FIG. 5 is a cross-sectional view of the shaft assembly of the delivery device taken along line 5-5 of FIG. 4B. [Figure 6] FIG. 6 is a perspective view of a portion of an actuation assembly of a delivery device. [Figure 7A] FIG. 7A is a perspective view of an actuation assembly of a delivery device aligned with an actuator of a prosthetic heart valve. [Figure 7B] FIG. 7B is a perspective view of an actuation assembly that engages with an actuator. [Figure 7C] FIG. 7C is a perspective view of the outer sleeve of the actuation assembly engaging with the frame of the prosthetic heart valve. [Figure 8] FIG. 8 is a cross-sectional view of the handle of the delivery device taken along line 8-8 of FIG. 4A. [Figure 9A] FIG. 9A is a portion of the handle of a delivery device showing a gearbox within the handle coupled to a knob on the handle. [Figure 9B] FIG. 9B is a perspective view of the gearbox, with the gearbox housing shown as transparent. [Figure 9C] FIG. 9C is a perspective view of a portion of the handle of the delivery device, showing the interior compartment of the gearbox housing. [Figure 10A] FIG. 10A is a perspective view of the gear train of the gearbox. [Figure 10B] FIG. 10B is a plan view of the gear train, oriented parallel to the longitudinal axis of the handle. [Figure 10C] FIG. 10C is a plan view of the gear train, transverse to the longitudinal axis of the handle. [Figure 11] FIG. 11 is another perspective view of the prosthetic heart valve without the valvular structure and showing the division of the actuation rods into two sets. [Figure 12] FIG. 12 is a schematic diagram of a delivery assembly including a prosthetic heart valve in a radially expanded configuration and a delivery device. [Figure 13A] FIG. 13A is a perspective view of a torque limiter for an actuator driver. [Figure 13B] FIG. 13B is a cross-sectional view of the torque limiter taken along line 13B-13B of FIG. 13A. [Figure 14] FIG. 14 is a perspective view of a torsion spring. [Figure 15] FIG. 15 is a perspective view of a first rotating body of a rotating assembly of the torque limiter. [Figure 16] FIG. 16 is a perspective view of a second rotating body of the rotating assembly of the torque limiter. [Figure 17A] FIG. 17A is a cross-sectional view of the torque limiter taken generally along line 17A-17A of FIG. 13B. [Figure 17B] FIG. 17B is a cross-sectional view of the torque limiter taken generally along line 17B-17B of FIG. 13B. [Figure 18] FIG. 18 is a cross-sectional view of a torque limiter disposed within a housing. [Figure 19] FIG. 19 is a cross-sectional view of the torque limiter in the housing taken along line 19-19 of FIG. [Figure 20A] 20A and 20B show the approximation of the arms of a torsion spring during twisting of the torsion spring. [Figure 20B] 20A and 20B show the approximation of the arms of a torsion spring during twisting of the torsion spring. [Figure 21A] FIG. 21A is a cross-sectional view of the proximal end portion of the handle showing the load cell attached to the body of the handle. [Figure 21B] FIG. 21B is a portion of the handle showing the plate extension on the gearbox that contacts the load cell. [Figure 22A] FIG. 22A is a top view of the gearbox housing. [Figure 22B] FIG. 22B is a side view of the gearbox housing. [Figure 22C] FIG. 22C is a proximal end view of the gearbox housing. [Figure 22D] FIG. 22D is a cross-sectional view of the gearbox housing taken along line 22D-22D of FIG. 22B. [Figure 22E] FIG. 22E is a cross-sectional view of the gearbox housing taken along line 22E-22E of FIG. 22B. [Figure 22F] FIG. 22F is a cross-sectional view of the gearbox housing taken along line 22F-22F of FIG. 22B. [Figure 22G] FIG. 22G is a cross-sectional view of the gearbox housing taken along line 22G-22G of FIG. 22B. [Fig. 22H] FIG. 22H is a cross-sectional view of the gearbox housing taken along line 22H-22H of FIG. 22B. [Figure 22I] FIG. 22I is a perspective view of the distal end portion of the gearbox housing. [Figure 22J] FIG. 22J is a distal end view of the gearbox housing. [Figure 22K] FIG. 22K is a perspective view of the gearbox showing the encoder mounted on the output shaft. [Diagram 23] FIG. 23 is a perspective view of a portion of the handle showing the pull body coupled to the knob and gear box. [Figure 24A] FIG. 24A is a perspective view of a portion of the handle showing the pull body coupled to the gearbox. [Figure 24B] FIG. 24B is a perspective view of the pull body as viewed from its end. [Figure 24C] FIG. 24C is a perspective view of the pull body. [Figure 24D]FIG. 24D is a cross-sectional view of the pull body taken along a plane extending along line 24D-24D of FIG. 24C. [Figure 24E] FIG. 24E is a cross-sectional view of a portion of the handle taken along a plane extending along line 24E-24E in FIG. 24A, where the slide arm of the pull body abuts against a first stop surface on the gearbox housing. [Figure 24F] FIG. 24F is a cross-sectional view shown in FIG. 24E where the slider arm of the pull body abuts a second stop surface on the gearbox housing. [Figure 24G] FIG. 24G is a cross-sectional view of a portion of the handle taken along a plane extending along line 24G-24G of FIG. 24A. [Figure 25A] FIG. 25A is a cross-sectional view of a knob having an internal channel. [Figure 25B] FIG. 25B is a cross-sectional view of the knob along a plane extending along line 25B-25B of FIG. 25A. [Figure 26] FIG. 26 is a cross-sectional view of the handle taken along line 26-26 of FIG. 4A. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0020] General Considerations

[0021] The subject matter is described using implementations and examples. In some cases, as will be recognized by those skilled in the art, the disclosed implementations and examples may be practiced without one or more of the specific details disclosed, or may be practiced with other methods, structures, and materials not specifically disclosed herein. All implementations and examples described herein and shown in the drawings may be combined, without any limitation, to form any number of combinations, unless the context clearly dictates otherwise, such as when the proposed combination includes incompatible or mutually exclusive elements. The sequential order of the actions in any process described herein may be rearranged, unless the context clearly dictates otherwise, such as when one action requires the result of another action as input.

[0022] For brevity and continuity of description, the same or similar reference characters may be used for the same or similar elements in different figures, and a description of an element in one figure is considered to be carried over when the element appears in another figure with the same or similar reference character. In some instances, the term "corresponding to" may be used to describe the correspondence between elements of different figures. In the examples used, when an element in a first figure is described as corresponding to another element in a second figure, the element in the first figure is considered to have the characteristics of the other element in the second figure, and vice versa, unless otherwise stated.

[0023] The word "comprise" and its derivatives such as "comprises" and "comprising" should be interpreted in an open, inclusive sense, i.e., "including, but not limited to." The singular forms "a," "an," "at least one," and "the" include plural references unless the context dictates otherwise. The term "and / or," when used between the last two elements of a list of elements, means any one or more of the listed elements. The term "or" is generally used in its broadest sense, i.e., "and / or," unless the context clearly dictates otherwise.

[0024] The term "coupled" without a modifier generally means physically coupled or connected and does not exclude the presence of intermediate elements between coupled elements unless specifically stated to the contrary. The terms "plurality" or "plurality" when used with an element means two or more of the element. Directions and other relative references (e.g., medial and lateral, upper and lower, superior and inferior, left and right, and proximal and distal) may be used to facilitate discussion of the figures and principles herein but are not intended to be limiting.

[0025] The terms "proximal" and "distal" are defined relative to the location of use of the delivery device. Generally, the end of the delivery device closest to the user of the device is the proximal end, and the end of the delivery device furthest from the user (e.g., the end inserted into the patient's body) is the distal end. When used with two spatially separated locations or portions of an object, the term "proximal" may be understood to mean closer to or oriented toward the proximal end of the delivery device. When used with two spatially separated locations or portions of an object, the term "distal" may be understood to mean closer to or oriented toward the distal end of the delivery device.

[0026] Introduction to the disclosed technology

[0027] Described herein are prosthetic heart valves, delivery devices, and methods for implanting the prosthetic heart valves. The prosthetic heart valves may include two or more actuators operable to radially expand or radially compress the prosthetic heart valve. The delivery device may include an actuator driver for releasably engaging and operating the actuators.

[0028] In some examples, the delivery device may include a counter-rotation mechanism operably coupled to the actuator such that a net moment force on the prosthetic heart valve is substantially zero during actuation of the actuator. During expansion of the prosthetic heart valve using the actuator, the counter-rotational movement of the actuator may help maintain the prosthetic heart valve in a rotationally fixed position relative to the native anatomy.

[0029] In some examples, the counter-rotation mechanism can include a gear box pivotally mounted within a handle of the delivery device and coupled to an actuator driver. In some examples, a stop member can be disposed within the handle to engage the gear box and limit its pivoting during expansion of the prosthetic heart valve. In some examples, the stop member can include a sensor to measure a load on the gear box while the gear box is engaged with the stop member.

[0030] In some examples, the delivery device may include a mechanism for limiting the torque applied to the actuator driver during expansion of the prosthetic heart valve. The torque limiter may be configured to stop the gear train of the gear box when the torque applied to the actuator driver is within a predetermined maximum torque tolerance.

[0031] Examples of the disclosed technology

[0032] FIG. 1 illustrates a prosthetic heart valve 100, according to one embodiment. The prosthetic heart valve 100 may be configured to replace a native heart valve (e.g., an aortic valve, a mitral valve, a pulmonary valve, and / or a tricuspid valve). The prosthetic heart valve 100 is illustrated as a mechanically expandable prosthetic heart valve that can be radially compressed for delivery to an implantation location within a patient's body and then radially expanded to an operating diameter at the implantation location. The prosthetic heart valve 100 may include a frame 104 having an annular shape. The prosthetic heart valve 100 may further include a valve structure 108 coupled to and supported within the frame 104.

[0033] In an example, the valvular structure 108 includes one or more leaflets 112 made of a flexible material and configured to open and close to regulate blood flow. In one example, the valvular structure 108 may have three leaflets 112, which may be arranged to be folded in a tricuspid configuration. The leaflets 112 may be made in whole or in part of pericardial tissue (e.g., bovine pericardial tissue), a biocompatible synthetic material, or a variety of other suitable natural or synthetic materials.

[0034] As shown more clearly in FIG. 2A , the frame 104 has an inlet end 116, an outlet end 120, and a longitudinal axis L extending in a direction from the inlet end 116 to the outlet end 120. The frame 104 may include a plurality of support posts 124, 128 aligned with the longitudinal axis L and spaced apart along the periphery of the frame 104. In one example, the support posts 124, 128 may be arranged in an alternating manner along the periphery of the frame 104. The frame 104 may further include a plurality of struts 132 extending circumferentially between and interconnecting adjacent support posts 124, 128. The struts 132 and the support posts 124, 128 define cells 136 of the frame 104. As shown, the struts 132 may have a curved shape.

[0035] 1 and 2A, one or more interdigital windows 140 may be formed in one or more of the support posts 124. Interdigital portions 144 may be formed in the interdigital windows 140 for coupling the leaflets 112 to the frame 104. One or more of the support posts 124 may further include a cantilever strut 148 that extends to the inflow end 116 of the frame 104. In some cases, the inflow edge 152 of the leaflets 112 may be attached to the cantilever strut 148 (e.g., by sutures 154) and / or to selected struts 132 of the frame 104 (e.g., using sutures 156).

[0036] In one example, the frame 104 may be adjusted between a radially expanded configuration and a radially compressed configuration by deflecting the posts 132. In one example, the frame 104 (e.g., the posts and the posts) may be made of a biocompatible, plastically expandable material that allows the frame 104 to be adjusted between a radially expanded configuration and a radially compressed configuration. Suitable examples of plastically expandable materials that may be used to form the frame 104 include, but are not limited to, stainless steel, cobalt chromium alloy, and / or nickel titanium alloy (which may also be referred to as "NiTi", or "nitinol").

[0037] 2A, in one example, one or more actuators 168 may be coupled to the support posts 128 and used to adjust the frame 104 between a radially expanded configuration and a radially compressed configuration. In one example, each support post 128 may include an upper post member 160 and a lower post member 164 (the terms "upper" and "lower" are relative to the orientation of the frame 104 in FIG. 1) aligned with the longitudinal axis L of the frame 104 and having opposing ends separated by a gap G. Each actuator 168 may be coupled to the post members 160, 164 and operable to increase or decrease the gap G to radially compress or expand the frame 104.

[0038] In one example, the actuator 168 may include an actuator rod 172 having an actuator head 176 attached thereto. In the example shown in Figures 2A and 2B, the actuator rod 172 extends through or into the post members 160, 164 and across the gap G. In the example shown in Figure 2A, the actuator rod 172 is inserted into the upper post member 160 from the outflow end 120, and the actuator head 176 is disposed or carried at the outflow apex of the upper post member 160. In the example shown in Figure 2B, the actuator rod 172 is inserted into the lower post member 164 from the inflow end 116, and the actuator head 176 is disposed or carried at the inflow apex of the lower post member 164.

[0039] In some embodiments, the actuator rod 172 is externally threaded. As shown in Figures 2A and 2B, the bottom post member 164 can include a nut 180 having internal threads for threaded engagement with the actuator rod 172. In this case, the actuator rod 172 can be moved longitudinally by rotating the actuator rod 172 relative to the nut 180. In some embodiments, the actuator rod 172 can be freely slidable relative to the top post member 160. In other examples, the actuator rod 172 can be threadedly engaged with the top post member 160.

[0040] 3, the actuator head 176 can include a pair of protrusions 184 that form a slot 188. The actuator head 176 can further include one or more shoulders 192. As will be described further, an actuation assembly of a delivery device can releasably engage with the actuator head 176 via the slot 188 and the shoulders 192.

[0041] 2A and 2B, in one scenario, the actuator rod 172 may be rotated in a first direction to move the upper post member 160 toward the lower post member 164, thereby decreasing the size of the gap G, which may have the effect of radially expanding the frame 104. In another scenario, the lower post member 164 may be held stable while the actuator rod 172 is rotated in a second direction to move the upper post member 160 away from the lower post member 164, thereby increasing the size of the gap G, which may have the effect of radially compressing the frame 104. To avoid over-crimping the prosthetic heart valve, a stopper 185 (e.g., a nut) may be placed on the actuator rod 172 to limit the movement of the actuator rod 172 while the actuator rod 172 is rotated to radially compress the frame 104.

[0042] In an alternative implementation, as described further, some of the actuator rods 172 can rotate in one direction while other actuator rods 172 simultaneously rotate in the opposite direction to either radially expand the frame or radially compress the frame. This counter-rotation of the actuator rods can be used to help reduce the likelihood of the entire frame 104 rotating about the longitudinal axis L during rotation of the actuator rods 172 about their respective axes (e.g., when radially expanding the frame 104).

[0043] Additional examples of mechanically expandable valves can be found in International Application No. PCT / US2021 / 052745 and U.S. Provisional Patent Application No. 63 / 209904, which are incorporated by reference herein.

[0044] 4A and 4B illustrate a delivery device 200 according to one embodiment. The delivery device 200 may be used to deliver the prosthetic heart valve 100 to an implantation location within a patient's body. The delivery device 200 includes a handle 204 and a shaft assembly 208 coupled to the handle 204. The delivery device 200 may further include one or more actuation assemblies 220 that releasably couple the prosthetic heart valve 100 to a distal end portion of the shaft assembly 208 and may be used to radially expand and / or compress the prosthetic heart valve 100.

[0045] The prosthetic heart valve 100 is shown in an expanded configuration in Figure 4B. To facilitate delivery of the prosthetic heart valve 100 to an implantation location, the delivery device 200 (and / or other crimping devices) can be used to move the prosthetic heart valve 100 from a radially expanded functional configuration to a radially compressed delivery configuration. Once in the implantation location, an actuation driver of the actuation assembly 220 can operate the actuator 168 of the prosthetic heart valve 100 to radially expand the prosthetic heart valve 100 to an operating diameter.

[0046] In one example, the handle 204 includes a proximal body portion 212 and a distal body portion 216 coupled together. The body portions 212, 216 define a cavity (shown as 205 in FIG. 8 ) that extends along the longitudinal axis L1 of the handle 204. Various features of the delivery device 200 are disposed within the cavity 205.

[0047] 4B and 5, the shaft assembly 208 may include an outer delivery shaft 224 having a lumen 225 extending along the entire length of the shaft. The shaft assembly 208 may include a multi-lumen delivery shaft 228 extending through the lumen 225 and having lumens 234, 242. The shaft assembly 208 may include a nosecone shaft 232 extending through the lumen 234. The actuation assembly 220 may extend through the lumen 242. The lumen 234 may be centrally disposed within the multi-lumen delivery shaft 228, and the lumens 242 may be angularly spaced (evenly or non-uniformly) around a central axis of the multi-lumen delivery shaft 228 and disposed about the lumen 234.

[0048] In one example, a proximal end portion of the nosecone shaft 232 extends into a portion of the cavity of the handle 204 defined in the proximal body portion 212 (shown in FIG. 4A ), and a distal end portion of the nosecone shaft 232 extends distally from the distal end of the multi-lumen delivery shaft 228 (shown in FIG. 4B ). The prosthetic heart valve 100 can be disposed about the distal end portion of the nosecone shaft 232 when releasably coupled to the actuation assembly 220.

[0049] Nosecone shaft 232 may define a guidewire lumen 236 for receiving a guidewire. As shown in FIG. 4B, nosecone 240 may be attached to a distal end of nosecone shaft 232. Nosecone 240 may have a central opening 241 that is aligned with and connected to guidewire lumen 236. During an implantation procedure, a guidewire may be initially inserted into the patient's vasculature. A proximal end of the guidewire may be inserted into central opening 241 of nosecone 240 to allow delivery device 200 to be advanced through the patient's vasculature to an implantation location over the guidewire.

[0050] 6 shows a distal end portion of an actuation assembly 220. Each actuation assembly 220 can include an outer sleeve 244 and an actuator driver 248 extending through the outer sleeve 244. In an example, the actuator driver 248 includes a distal head having a central protrusion 252 and one or more flexible elongated elements 254. The central protrusion 252 can be configured to extend into a slot 188 (shown in FIG. 3 ) of an actuator head 176 of a prosthetic heart valve actuator 168. The flexible elongated elements 254 can have a radial protrusion 256 configured to engage a shoulder 192 (shown in FIG. 3 ) of the actuator head 176.

[0051] 7A-7C illustrate engagement of the actuation assembly 220 with each of the actuators 168. Initially, the distal end portion of the actuation assembly 220 is aligned with the actuator head 176 of the actuator 168, as shown in FIG. 7A. Next, the distal end portion of the actuator driver 248 is advanced such that the central projection 252 of the actuator driver 248 is disposed within the slot 188 of the actuator head 176 of the actuator 168. Once the central projection 252 engages the slot 188, the flexible elongated element 254 is disposed to the side of the actuator head 176 and the radial projection 256 of the flexible elongated element 254 is positioned distal to a shoulder 192 on the actuator head 176, as shown in FIG. 7B.

[0052] The outer sleeve 244 may be advanced over the distal end portion of the actuator driver 248 to radially compress the flexible elongated element 254 against the actuator head 176 until the radial protrusion 256 abuts the shoulder 192, thereby coupling the actuator driver 248 to the actuator 168. The outer sleeve 244 may be advanced further until the outer sleeve 244 engages the frame 104, as shown in FIG. 7C.

[0053] The outer sleeve 244 can have first and second support extensions 260 that define a gap or notch 262 between the extensions 260. As shown in FIG. 7C, the support extensions 260 can be oriented such that the support extensions 260 extend partially over a proximal end portion of the upper post arm 160 of each support post 128 when the actuation assembly 220 is coupled to a respective actuator 168. The engagement of the support extensions 260 with the frame 104 can counteract a rotational force applied to the frame 104 by the actuator rod 172 during expansion of the frame 104.

[0054] A variety of other coupling mechanisms can be used to releasably couple the prosthetic heart valve to the actuation assembly of the delivery device, for example, additional coupling mechanisms are described in U.S. Patent Application Serial No. 63 / 194,285 and U.S. Patent Application having Attorney Docket No. 12052US01, which are incorporated herein by reference.

[0055] 4A, the handle 204 may include one or more knobs that may be configured to perform various functions of the delivery device 200 to deliver the prosthetic heart valve 100 to an implantation location within a patient. In one example, the handle 204 may include a first knob 264, a second knob 268, and a third knob 272. In one example, the knobs 264, 268, 272 may be rotatable knobs relative to the handle body portions 212, 216 about the longitudinal axis L1 of the handle 204. The handle 204 may include other knobs, such as a safety knob 276, that may be rotatable or slidable.

[0056] In the example, the first knob 264 is located at a proximal end of the handle 204 and may be used to operate the actuation assembly 220 of the delivery device 200 and the actuator 168 of the prosthetic heart valve 100. As shown in FIG. 8 , the first knob 264 may be configured to operate a gear box 300 disposed within a proximal portion of the cavity 205 of the handle 204. The actuator driver 248 of the actuation assembly 220 may be coupled to the gear box 300 such that it is rotated by the gear box 300. Rotation of the actuator driver 248 may be translated into rotational motion of the actuator 168 of the prosthetic heart valve 100.

[0057] In an example, the second knob 268 is located where the proximal body portion 212 and the distal body portion 216 of the handle 204 are coupled together. The second knob 268 can be configured to release the actuation assembly 220 from the prosthetic heart valve 100 (e.g., after positioning the prosthetic heart valve 100 at a desired implantation location and expanding the prosthetic heart valve 100 to an operating diameter). In an example, the safety knob 276 can be configured to prevent unintentional release of the actuation assembly 220 from the prosthetic heart valve. For example, the safety knob 276 can slide into a recess in the second knob 268 to prevent rotation of the second knob 268. The safety knob 276 can be pulled out of the recess to rotate the second knob 268.

[0058] In the example, the third knob 272 is located at the distal end of the handle 204. The third knob 272 can be configured such that rotation of the knob relative to the handle body effects axial translation of the outer delivery shaft 224 relative to the actuation assembly 220, the prosthetic heart valve 100, and the nosecone shaft 232.

[0059] In one example, a delivery capsule 226 (shown in FIG. 4B ) can be attached to a distal end of the outer delivery shaft 224. Axial movement of the outer delivery shaft 224 in a distal direction relative to the other shafts and the prosthetic valve can move the delivery capsule 226 over a distal end portion of the actuation assembly 220 and the prosthetic heart valve 100 (i.e., when the prosthetic heart valve 100 is in a radially compressed configuration) such that the prosthetic heart valve 100 is encapsulated within the delivery capsule. Axial movement of the outer delivery shaft 224 in a proximal direction relative to the other shafts and the prosthetic valve can pull the delivery capsule 226 out of the prosthetic heart valve 100, exposing the prosthetic heart valve, for example, for deployment at an implantation location. In some embodiments, the third knob 272 can be operably coupled to a carriage 280 in a distal portion of the cavity 205 of the handle 204. The outer delivery shaft 224 may be coupled to the carriage 280 such that movement of the carriage 280 by rotation of the third knob 272 results in axial displacement of the outer delivery shaft 224 .

[0060] During expansion of the prosthetic heart valve 100, rotation of the actuator 168 can apply moment forces to the frame 104, i.e., due to frictional forces acting between the frame 104 and the actuator rod 172 of the actuator 168. These moment forces can, in some cases, cause the frame 104 to rotate or pivot about the longitudinal axis L of the frame during the expansion / contraction procedure. To help reduce such rotation of the entire frame, the actuators 168 can be split into two sets, which can rotate in opposite directions such that moment forces due to the actuators of one set are counterbalanced by moment forces due to the actuators of the other set. This can, for example, help the frame 104 to remain rotationally fixed, or at least substantially rotationally fixed, during expansion of the prosthetic heart valve. This configuration can thus, for example, make positioning and / or deployment of the prosthetic heart valve relatively easy and / or predictable.

[0061] 9A-9C, the gearbox 300 of the handle 204 may include a gearbox housing 304 having various compartments 306 for holding components of a gear train 308. The output shaft of the gear train 308 may be coupled to the actuator driver 248 such that operation of the gear train 308 results in rotation of the actuator driver 248 and, consequently, rotation of the actuators 168 of the prosthetic heart valve 100. In one example, the gearbox 300 may be a counter-rotating gearbox, where the gear train 308 is configured to rotate two sets of actuator drivers in opposite directions.

[0062] 10A-10C show one implementation of the gear train 308. In an example, the gear train 308 includes an input shaft 324 and an input gear 320 coupled to the input shaft 324. In one example, the input shaft 324 is aligned with the longitudinal axis L1 of the handle 204 (as shown in FIG. 8). The input shaft 324 can be coupled to the first knob 264 of the handle 204 (as shown in FIG. 8) such that rotation of the first knob 264 results in rotation of the input shaft 324. The input gear 320 rotates with the input shaft 324. The rotation direction R1 of the input gear 320 can be clockwise or counterclockwise depending on the direction in which the first knob 264 rotates.

[0063] The gear train 308 may include a transmission gear 328 coupled to a transmission shaft 332, which may be disposed parallel to the input shaft 324. Teeth of the input gear 320 mesh with teeth of the transmission gear 328 such that rotation of the input gear 320 drives the transmission gear 328. The transmission shaft 332 rotates with the transmission gear 328. In one example, rotation of the input gear 320 in a first direction R1 drives the transmission gear 328 in a second direction R2 opposite the first direction (whether R2 is clockwise or counterclockwise depends on the rotational direction R1 determined by rotation of the first knob 264).

[0064] The gear train 308 may include a first drive gear 336 coupled to the transmission shaft 332 and disposed distally of the transmission gear 328. In this case, rotation of the transmission shaft 332 in response to driving the transmission gear 328 by the input gear 320 is translated into rotation of the first drive gear 336. The first drive gear 336 rotates in the same direction R2 as the transmission gear 328.

[0065] The gear train 308 may include a second drive gear 340 supported on a drive shaft 342 disposed parallel to the transmission shaft 332. The teeth of the second drive gear 340 mesh with the teeth of the first drive gear 336 such that rotation of the first drive gear 336 drives the second drive gear 340. The drive shaft 342 rotates with the second drive gear 340. The second drive gear 340 rotates in a direction R1 opposite to the direction R2 in which the first drive gear 336 rotates.

[0066] The gear train 308 may include a set of first output gears (which may also be referred to as "pinion gears") that are angularly spaced about a central axis of the first drive gear 336 and have teeth that mesh with the teeth of the first drive gear 336. In an example, the first set of output gears includes output gears 344a, 344b, 344c. The output gears 344a, 344b, 344c rotate in a direction R1 opposite to the direction R2 in which the first drive gear 336 rotates. In one example, the output gears 344a, 344b, 344c are coupled to output shafts 346a, 346b, 346c, respectively. The output shafts 346a, 346b, 346c may be coupled to a first set of actuator drivers.

[0067] The gear train 308 may include a second set of output gears (which may also be referred to as "pinion gears") that are angularly spaced about a central axis of the second drive gear 340 and have teeth that mesh with the teeth of the second drive gear 340. In an example, the second set of output gears includes output gears 344d, 344e, and 344f. The output gears 344d, 344e, and 344f rotate in a direction R2 opposite to the direction R1 in which the second drive gear 340 rotates. Thus, the output gears 344d, 344e, and 344f of the second set of output gears rotate in a direction opposite to the direction in which the output gears 344a, 344b, and 344c of the first set of output gears rotate. In one example, the output gears 344d, 344e, and 344f are coupled to output shafts 346d, 346e, and 346f, respectively. The output shafts 346d, 346e, 346f may be coupled to a second set of actuator drivers.

[0068] 11 shows frame 104 having actuators 168a, 168b, 168c, 168d, 168e, and 168f coupled to support posts 128a, 128b, 128c, 128d, 128e, and 128f, respectively. In one example, a first set of actuators can include actuators 168a, 168b, and 168c, and a second set of actuators can include actuators 168d, 168e, and 168f. As shown in FIG. 12, a first set of actuators 168a, 168b, 168c may be coupled to a first set of actuator drivers 248a, 248b, 248c, and a second set of actuators 168d, 168e, 168f may be coupled to a second set of actuator drivers 248d, 248e, 248f (for simplicity, some details of the delivery device are not shown in FIG. 12, e.g., the body of the handle 204 and the outer delivery shaft 224 from which the multi-lumen delivery shaft 228 extends are not shown).

[0069] 11, actuator rods 172a, 172b, 172c of actuators 168a, 168b, 168c in a first set of actuators can have threads with a first configuration (e.g., right-hand threads). Actuator rods 172d, 172e, 172f of actuators 168d, 168e, 168f in a second set of actuators can have threads with a second configuration opposite the first configuration (e.g., left-hand threads). For example, if actuator rods 172a, 172b, 172c have right-hand threads, actuator rods 172d, 172e, 172f can have left-hand threads (or vice versa). Thus, when a first set of actuators 168a, 168b, 168c and a second set of actuators 168d, 168e, 168f rotate simultaneously in opposite directions, all of the actuators act in concert to either increase their respective gaps G or decrease gap G.

[0070] Other embodiments are possible in which the actuators are divided into two sets. For example, a first set of actuators may include actuators 168a, 168c, 168e, and a second set of actuators may include actuators 168b, 168d, 168f (i.e., alternating actuators around the circumference of the frame may be included in the sets). In this case, actuator rods 172a, 172c, 172e of the first set of actuators may have threads having a first configuration (e.g., right-hand threads), and actuator rods 172b, 172d, 172f of the second set of actuators may have threads having a second configuration opposite the first configuration (e.g., left-hand threads).

[0071] An example is provided of a prosthetic heart valve 100 having six actuators, divided into two sets. In other examples, the prosthetic heart valve may have more than six actuators (e.g., 7-15) or less than six actuators (e.g., 1-5). In other cases, the prosthetic heart valve may have an odd number of actuators, where one set of actuators may have a greater number of actuators compared to the other set of actuators. The number of actuation assemblies / actuator drivers of the delivery device may generally match the number of actuators of the prosthetic heart valve.

[0072] In the simplified diagram of Figure 12, each of the actuator drivers 248a, 248b, 248c of the first set of actuator drivers extends through the multi-lumen delivery shaft 228 and is connected to each of the actuators 168a, 168b, 168c of the prosthetic heart valve 100. Similarly, each of the actuator drivers 248d, 248e, 248f of the second set of actuator drivers extends through the multi-lumen delivery shaft 228 and is connected to each of the actuators 168d, 168e, 168f of the prosthetic heart valve 100. The actuator drivers 248a, 248b, 248c are coupled to a first set of output shafts of the gearbox 300 (346a, 346b, 346c in FIGS. 10A-10C), and the actuator drivers 248d, 248e, 248f are coupled to a second set of output shafts of the gearbox 300 (346d, 346e, 346f in FIGS. 10A-10C). The input shaft 324 of the gearbox 300 is coupled to the first knob 264.

[0073] To expand the prosthetic heart valve 100, for example, radially at the implantation location, the first set of actuator drivers 248a, 248b, 248c and the second set of actuator drivers 248d, 248e, 248f can be rotated in opposite directions using the first knob 264. The opposite rotation of the two sets of actuator drivers results in opposite rotation of the first set of actuators 168a, 168b, 168c and the second set of actuators 168d, 168e, 168f. This opposite rotation of the two sets of actuators can advantageously help reduce the possibility of the prosthetic heart valve rotating relative to its own anatomy during expansion of the prosthetic heart valve.

[0074] In some implementations, a torque limit may be defined for each actuator driver 248, and one or more torque limiters (e.g., one for each actuator driver 248) may be provided to prevent the torque on the actuator driver 248 from exceeding a predetermined limit. The torque limiters may prevent overloading of the actuator driver 248, for example, during expansion of the prosthetic heart valve 100. In one example, the torque limiter limits the rotation of the corresponding actuator driver 248 when the torque on the actuator driver 248 reaches a predetermined limit. Because all actuator drivers 248 are coupled to the gear train 308, the gear train 308 is effectively stopped when any of the actuator drivers 248 is stopped by the torque limiter.

[0075] 13A and 13B illustrate a torque limiter 400, according to one embodiment. The torque limiter 400 may couple the actuator driver 248 to the output shaft 346 of the gear train 308 and may operate to prevent rotation of the actuator driver 248 when the torque on the actuator driver 248 is within a predetermined torque limit range. The upper limit of the predetermined torque limit range may be a maximum torque on the actuator driver 248 and the lower limit of the predetermined torque limit range may be a torque within a tolerance of the maximum torque (e.g., within 15% of the maximum torque). In one example, the maximum torque on the actuator driver 248 may be 50 N-mm. The torque limiter 400 may be housed within a compartment of the gearbox housing 304. For illustrative purposes, FIG. 9B illustrates the torque limiter 400 within one of the compartments 306 of the gearbox housing 304. 9B and 9C, in some embodiments, the handle 204 for the delivery device 200 can include multiple (e.g., 2-15) torque limiters 400. For example, each actuation driver 248 of the delivery device can have its own torque limiter 400.

[0076] Returning to FIGS. 13A-13B, the torque limiter 400 has a longitudinal axis L2. The torque limiter 400 includes a rotatable assembly 401 aligned with and rotatable about the longitudinal axis L2. The rotatable assembly 401 couples a connector shaft 402 to one of the output shafts 346 of the gearbox 300. The output gear 344 is coupled to the output shaft 346 as described above. One of the actuator drivers 248 may be coupled to the connector shaft 402 at a coupling section 403 of the connector shaft 402 (e.g., using one or more set screws 407). In one mode, the rotatable assembly 401 allows the connector shaft 402 to rotate with the output shaft 346. In another mode, the rotatable assembly 401 prevents rotation of both the connector shaft 402 and the output shaft 346.

[0077] The rotatable assembly 401 includes a first rotatable body 404 and a second rotatable body 408. In an example, the second rotatable body 408 is positioned distal to the first rotatable body 404, and both the first and second rotatable bodies 404, 408 are rotatable about the longitudinal axis L2. The first rotatable body 404 is fixedly coupled to the output shaft 346 such that the first rotatable body 404 and the output shaft 346 can rotate together about the longitudinal axis L2. In an example, the first rotatable body 404 is positioned distal to the output gear 344. The second rotatable body 408 is fixedly coupled to the connector shaft 402 such that the second rotatable body 408 and the connector shaft 402 can rotate together about the longitudinal axis L2.

[0078] In one example, the first rotatable body 404 includes a proximal axial bore 412 and a distal axial bore 416. A distal end portion of the output shaft 346 is inserted into and engages the proximal axial bore 412 in a manner that allows the first rotatable body 404 to rotate with the output shaft 346. In one example, the proximal axial bore 412 can have a non-circular cross-sectional profile (taken in a plane perpendicular to the longitudinal axis L2) that is adapted to match a non-circular cross-sectional profile (taken in a plane perpendicular to the longitudinal axis L2) on the input shaft 346 such that rotation of the input shaft 346 results in rotation of the first rotatable body 404. For example, the non-circular cross-sectional profile of the proximal axial bore 412 may be “D-shaped” (which may also be referred to as “flat”), which may engage a similarly D-shaped (or “flat”) output shaft 346 to allow the first rotatable body 404 to rotate in the same direction as the output shaft 346. Alternatively, the output shaft 346 may be attached to the proximal axial bore 412 (e.g., by welding, adhesive, or other means for a fixed connection) to allow the first rotatable body 404 to rotate with the output shaft 346.

[0079] The second rotatable body 408 may include an axial bore 420 that aligns with the distal axial bore 416 of the first rotatable body 404. The connector shaft 402 extends through the axial bore 420 of the first rotatable body 404 and into the distal axial bore 416 of the first rotatable body 404. The connector shaft 402 may engage with the second rotatable body 408 in a manner that allows the connector shaft 402 to rotate with the second rotatable body 408. For example, the axial bore 420 may have a non-circular profile for engaging with a complementary non-circular profile on the connector shaft member 402. Alternatively, the connector shaft 402 may be attached (e.g., by welding, adhesive, etc.) to the axial bore 420 to allow the second rotatable body 408 to be rotatable with the connector shaft 402. In some embodiments, the distal end of the output shaft 346 and the proximal end of the connector shaft 402 may be axially spaced apart (eg, separated by a wall or shoulder of the first rotatable body 404).

[0080] In other examples, opposing ends of the connector shaft 402 and the output shaft 346 may axially overlap. In such examples, the shafts 402, 346 may include one or more features that facilitate alignment of the connector shaft 402 and the output shaft 346 along the longitudinal axis L2 while also allowing relative rotational movement between the connector shaft 402 and the input shaft 346. For example, in some instances, the connector shaft 402 (or at least a portion thereof) may include an outer diameter that is smaller than a diameter of an interior bore of the output shaft 346 such that the connector shaft may extend axially into the output shaft 346 (or vice versa).

[0081] In either case, the output shaft 346 and the connector shaft 402 are not fixedly coupled together and, therefore, in some cases, described further below, the output shaft 346 (and first rotatable body 404) and the connector shaft 402 (and second rotatable body 408) can rotate relative to one another.

[0082] In an example, the first rotatable body 404 and the second rotatable body 408 are coupled together by a rotational biasing member, such as a torsion spring 424. As shown in FIG. 14, the torsion spring 424 may be a helical torsion spring including a coil portion 426 that terminates at opposing ends in first and second end (or arm) portions 428, 430. The first end portion 428 and the second end portion 430 of the torsion spring 424 may extend radially outward beyond the coil portion 426 of the torsion spring 424. The torsion spring 424 may be configured such that the first end portion 428 is rotationally offset from the second end portion 430.

[0083] In one example, as shown in FIG. 15, the proximal end portion of the second rotatable body 408 can include a recess 432 and a connected lateral slot 436. The recess 432 can be centrally aligned with the longitudinal axis L2 and connected to the axial bore 420. As shown in FIG. 16, the distal end portion of the first rotatable body 404 can include a recess 440 and connected lateral slots 442, 444. The recess 440 can be centrally aligned with the longitudinal axis L2 and connected to the distal axial bore 416. The lateral slots 442, 444 are rotationally offset from one another about the longitudinal axis L2. As shown in FIG. 13B, the connector shaft 402 can extend through the recesses 432, 440 while passing through the axial bore 420 and into the distal axial bore 416.

[0084] The coil portion 426 of the torsion spring 424 may be disposed within the chamber formed by the aligned recesses 432, 440 with the first end portion 428 extending into the connected lateral slot 436 (as shown in FIG. 17A) and the second end portion 430 extending into one of the lateral slots 442, 444 of the first rotatable body 404 (as shown in FIG. 17B). In this position, the coil portion 426 is disposed around a portion of the connector shaft 402 that extends through the recesses 432, 440 (as shown in FIG. 13B). The central axis of the coil portion 426 is aligned with the longitudinal axis L2 of the torque limiter 400 such that both rotatable bodies 404, 408 can rotate about the central axis of the coil portion 426.

[0085] As shown in FIG. 17A, the end portions 430, 428 of the torsion spring 424 can engage with surfaces 444a, 436a of respective receiving slots 444, 436 formed in the rotatable bodies 404, 408. The torsion spring 424 can bias the rotatable bodies 404, 408 to an initial position in which the rotatable bodies 404, 408 rotate together as a single body. The torsion spring 424 is configured to twist the end portions 430, 428 toward each other when the torque on the actuator driver 248 is within a predetermined torque limit range. In some cases, the torsion spring 424 can be preloaded and the torsion spring 424 can begin to twist when the torque on the actuator driver 248 exceeds the preload of the torsion spring 424. The preload in the torsion spring 424 can be set as a lower limit of the predetermined range. The upper limit of the predetermined range can be a predetermined torque limit on the actuator driver 248, and the lower limit of the predetermined range can be less than the predetermined torque limit on the actuator driver 248 (e.g., within 10% to 15% of the predetermined torque limit). This means that the torsion spring 424 begins to twist as the actuator driver 248 approaches the predetermined torque limit, rather than after the actuator driver 248 reaches or exceeds the predetermined torque limit. In some cases, the predetermined torque limit can be 50 N-mm. The initial angular interval 429 shown in FIG. 17A corresponds to an initial position of the rotatable bodies 404, 408. The angular interval 429 becomes smaller as the end portions 430, 428 approach each other during twisting of the torsion spring 424.

[0086] 15, tapered recesses 448 may be formed on the outer surface 446 of the second rotatable body 408. In an example, each tapered recess 448 includes a first radial shoulder 452, a second radial shoulder 456 spaced circumferentially from the first radial shoulder 452 of the second rotatable body 408, and a portion 446a of the outer surface 446 between the first radial shoulder 452 and the second radial shoulder 456. The outer surface portion 446a, in one example, may be curved.

[0087] The radial projection of the first radial shoulder 452 is greater than the radial projection of the second radial shoulder 456 such that the recesses 448 taper radially (i.e., from deep to shallow) from the first radial shoulder 452 to the second radial shoulder 456. Each tapered recess may extend axially along the entire length of the second rotatable body 408 or partially along the length of the second rotatable body 408. In one example, two tapered recesses 448 are formed on the outer surface 446. The tapered recesses 448 are angularly spaced apart from each other around a central axis of the second rotatable body 408, which may be identical to the longitudinal axis L2 of the torque limiter. The angular spacing between the two tapered recesses 448 may be such that the two tapered recesses are diametrically opposed to each other around the central axis of the second rotatable body 408.

[0088] As further shown in FIG. 18, the rotatable assembly 401 of the torque limiter 400 may be disposed within a housing 460 such that an outer surface 446 of the second rotatable body 408 is surrounded by an inner surface 464 of the housing 460. The tapered recesses 448 of the outer surface 446 and the inner surface 464 may define a circumferentially tapered channel 468 disposed about the periphery of the second rotatable body 408, as shown more clearly in FIG. 19. The housing 460 may be a section of the gearbox housing 304 (e.g., one of sections 374a-f shown in FIG. 22G) or a separate housing attached to the gearbox housing 304.

[0089] As shown more clearly in FIG. 19, each channel 468 receives a wedge member 472. In one example, the wedge member 472 can be in the form of a longitudinal rod member. In one example, the wedge member 472 is fixedly coupled to the first rotatable body 404 such that the wedge member 472 rotates therewith. In one example, a proximal portion of the wedge member 472 extends into a longitudinal bore 476 of the first rotatable body 404 (shown in FIGS. 13A, 16, 17A, 17B, 19). The wedge member 472 can be held in place within the bore 476 using any suitable method (e.g., by friction, welding, adhesive, etc.).

[0090] 19, 20A, and 20B show the operation of the torque limiter 400. The first knob 264 of the handle 204 can be rotated to operate the gear train 308. During operation of the gear train 308, the gear train 308 rotates the output shaft 346. The first rotatable body 404 rotates with the output shaft 346. The rotation of the first rotatable body 404 is translated to the rotation of the second rotatable body 408 through the torsion spring 424. As the second rotatable body 408 rotates, the actuator driver 248 coupled to the second rotatable body 408 via the connector shaft 402 also rotates. In the state shown in FIG. 19, the torsion spring 424 is in its resting, unbiased state and has an initial angular difference 429 between the end portions 428, 430. In this condition, the wedge member 472 is freely received in the wide end of the channel 468 and the first and second rotatable bodies 404, 408 rotate together.

[0091] When the torque on the actuator driver 248 reaches a predetermined torque limit range, set by the size and characteristics of the torsion spring 424, the coil portion 426 of the torsion spring 424 twists in a manner that causes the end portions 428, 430 of the torsion spring 424 to move closer together. FIG. 20A shows that the end portions 428, 430 move closer together such that the angular spacing 429a between the end portions 428, 430 is less than the initial angular spacing 429 (shown in FIG. 19 ) (the initial angular spacing 429 shown in FIG. 19 is the sum of the angular spacings 429a, 429b shown in FIG. 20A ). As the torsion spring 424 twists, the first rotatable body 404 rotates relative to (rather than together with) the second rotatable body 408, as shown in FIG. 20A . As the first rotatable body 404 rotates relative to the second rotatable body 408, the wedge member 472 moves along the tapered channel 468 in a direction from the wide end of the channel to the narrow end of the channel, as indicated by arrow 475.

[0092] The first rotatable body 404 stops rotating when the wedge member 472 presses against the narrow end of the channel 468, which prevents further rotational movement of the wedge member 472 within the tapered channel 468 due to interference between the surface of the housing 460, the second rotatable body 408, and the wedge member 472, as shown in FIG. 20B. In this condition, the second rotatable body 408 also stops rotating. Because all of the gears in the gear train 308 are interconnected, when the actuator driver 248 reaches a torque limit that stops rotation of the first and second rotatable bodies 404, 408 and the output gear 344 associated with the actuator driver 248, the entire gear train 308 stops moving, preventing rotational movement of all other actuator drivers 248 coupled to the gear box 300.

[0093] In this manner, the torque limiter 400 can help ensure that the actuation member and / or prosthetic heart valve and / or other components of the delivery device operate within predetermined torque limits, which can, among other things, reduce or prevent the prosthetic heart valve from being damaged during expansion / contraction and / or prevent the prosthetic heart valve from being over-expanded against the natural annulus (and / or other natural tissue).

[0094] The gearbox housing 304 may include various compartments that house the components of the gear train 308 and the torque limiter 400, as shown in Figures 22A-22J.

[0095] In one example, as shown in FIGS. 22A-22D, the gearbox housing 304 can have a first housing section 310 (which can also be referred to as a first gear housing) forming a proximal end portion of the gearbox housing. The first housing section 310 can include compartments 312 and 314 for accommodating an input gear 320 (shown in FIGS. 10A-10C) and a transmission gear 328 (shown in FIGS. 10A-10C). The first housing section 310 can include a hole 316 for passage of a proximal end portion of an input shaft 324 (e.g., for coupling the proximal end portion of the input shaft 324 to the first knob 264 (shown in FIG. 12)). The first housing section 310 can include holes 318a-f for passage of proximal end portions of output shafts 346a-f (shown in FIGS. 10A-10C). The first housing section 310 may further include fastener holes 326 that can receive fasteners, such as bolts, that can be used to secure the first housing section 310 to other housing sections of the gearbox housing (shown in FIG. 22C).

[0096] In some instances, the first housing section 310 may include a mounting hole 322 for mounting an encoder around a proximal end portion of one of the output shafts 346a-f. For example, the mounting hole 322 may receive a fastener, such as a screw, used to mount the encoder to the first housing section 310 and around each of the output shafts. FIG. 22K shows an encoder 311 mounted to one of the output shafts. In one example, the encoder 311 may include a sensing member capable of detecting the number of rotations of the output shaft. In one example, the encoder may be a magnetic encoder including a magnetic sensor and a magnetic arrangement for generating a magnetic field. The magnetic sensor may detect changes in the magnetic field as the output shaft rotates. Other types of encoders, such as optical encoders, may be used.

[0097] In one example, as shown in FIGS. 22A-22E, the gearbox housing 304 can have a second housing section 330 (which can also be referred to as a "second gear housing") disposed adjacent to the first housing section 310. The second housing section 330 includes a central opening 348 and compartments 350a-f formed on a periphery of the central opening 348. The central opening 348 can accommodate the drive gears 336, 340 (shown in FIGS. 10A-10C). The compartments 350a-f can accommodate the output gears 344a-f (shown in FIGS. 10A-10C). The compartments 350a-f are longitudinally aligned with the holes 318a-f of the first housing section 310. The second housing section 330 can include fastener holes 354 that can align with the fastener holes 326 of the first housing section 310 to receive fasteners. The second housing section 330 may include an opening 349 that aligns with the compartment 312 in the first housing section 310. The opening 349 may allow the input shaft 324 to extend through the second housing section 330 when the input gear 320 is attached to the compartment 312.

[0098] 22A, 22B, 22E, and 22F, the gearbox housing 304 can have a third housing section 358 (which can also be referred to as a "shaft support") disposed adjacent to the second housing section 330 and forming a central opening 348 and end walls of compartments 350a-f of the second housing section 330. The third housing section 358 can include holes 362a-f (shown in FIG. 22F) for receiving output shafts 346a-f (shown in FIG. 10A-C) when the output gears 344a-f (shown in FIG. 10A-C) are disposed within the compartments 350a-f of the second housing section 330. The third housing section 358 may include holes 366 and 368 for receiving the transmission shaft 332 (shown in FIGS. 10A-10C ) and the drive shaft 342 when the drive gears 336, 340 are disposed within the central opening 348 of the second housing section 330. The third housing section 358 may include an opening 369 that aligns with the opening 349 of the second housing section 330. The opening 369 may allow the input shaft 324 to extend through the third housing section 358 when the input gear 320 is attached to the compartment 312 of the first housing section 310. The third housing section 358 may include fastener holes 370 that may align with the fastener holes 354 of the second housing section 330 and the fastener holes 326 of the first housing section 310 for receiving fasteners.

[0099] 22A, 22B, and 22G, the gearbox housing 304 can have a fourth housing section 372 (which can also be referred to as a “torque limiter housing”) disposed adjacent to the third housing section 358. The fourth housing section 372 can include segments 374a-f arranged in the same pattern as the holes 362a-f of the third housing section 358 and the segments 350a-f of the second housing section 330. Each of the segments 374a-f can house a torque limiter 400 (shown in FIG. 18), which can be coupled to a respective output shaft 346a-f extending through each of the holes 362a-f. The fourth housing section 372 includes holes 376a-f in end walls of the compartments 374a-f for passage of the connector shaft 402 of the torque limiter 400 outside of the fourth housing 372 when the rotatable assembly 401 (shown in FIG. 18) of the torque limiter 400 is received within the compartments 374a-f. The fourth housing section 372 may include a fastening hole 378 that may be aligned with the fastening holes 370, 354, 326 of the housing sections 358, 330, 310. The compartments 374a-f may be arranged in a pattern that defines a channel 375. The input shaft 324 may extend through the channel 375.

[0100] In one example, as shown in FIGS. 22A, 22B, 22G, and 22H, the gearbox housing 304 can have a fifth housing section 380 disposed adjacent to the fourth housing section 372. The fifth housing section 380 (which can also be referred to as a “release housing”) can form a distal end portion of the gearbox housing 304. The fifth housing section 380 can include a base member 381 that forms an end wall of the channel 375. A hole 382 can be formed in the base member 381 to allow the input shaft 324 to pass through the base member 381. The fifth housing section 380 can further include receptacles 384a-f formed in the base member 381 for receiving end portions (shown in FIG. 18 ) of the torque limiter 400 when the rotatable assembly 401 of the torque limiter 400 is disposed in the compartments 374a-f of the fourth housing section 372. The base member 381 may include openings 386a-f connected to the receptacles 384a-f such that a coupling section 403 of a connector shaft 402 of the torque limiter 400 may be mounted within or accessible through the openings 386a-f when the rotatable assembly 401 is disposed within the compartments 374a-f of the fourth housing section 372. The fifth housing section 380 may include fastener holes 388 that may be aligned with the fastener holes 378, 370, 354, 326 of the housing sections 372, 358, 330, 310 to receive fasteners.

[0101] In one example, as shown in FIGS. 22A, 22B, and 22H-22J, the fifth housing section 380 may further include a guide member 389 that protrudes from the base member 381. The guide member 389 may include a hole 390 that aligns with the hole 382 in the plate member 381 to receive an end portion of the input shaft 324. Thus, when the gearbox 300 is fully assembled, the input shaft 324 extends through all of the housing sections 310, 330, 358, 372, and 380 (as shown in FIGS. 24E and 24F). The input shaft 324 defines the longitudinal axis of the gearbox housing, which is also the axis about which the gearbox housing can pivot. The longitudinal axis of the gearbox housing 304 is aligned with the longitudinal axis L1 of the handle 204. A pair of guide slots 392 are formed on opposing surfaces (e.g., top and bottom) of the guide member 389. The guide slots 392 extend axially in a direction along the longitudinal axis of the gearbox housing. Each guide slot 392 has opposing end walls forming opposing stop surfaces 393, 394. A pair of guide channels 395 are formed on opposing sides of the guide member 389. The guide channels 395 extend axially in a direction along the longitudinal axis of the gearbox housing. As will be further described, the guide slots 392 and the guide channels 395 can guide translational movement of the pull body along the longitudinal axis L1 of the handle.

[0102] The various housing sections 310, 330, 358, 372, and 380 of the gearbox housing 304 may be provided as separate members that are fastened together or as an integral part of the gearbox housing 304. In some cases, two or more of the housing sections 310, 330, 358, 372, and 380 may be integrally formed such that the gearbox housing 304 has fewer components to fasten together. In some cases, the gearbox housing 304 may be provided in two halves that may be fastened together. In other cases, the housing sections of the gearbox housing 304 may be attached together using means other than fasteners, for example, by welding, adhesives, etc.

[0103] 23, the handle 204 may further include a pull body 500 disposed distally of the gearbox 300 and releasably engaged with the fifth housing section / release housing 380 of the gearbox housing 304. The second knob 268 may be rotatably engaged with the pull body 500 such that rotation of the second knob 268 relative to the handle body generates translational motion of the pull body 500 along the longitudinal axis L1 of the handle. The pull body 500 may be coupled to the outer sleeve 244 of the actuation assembly 220 such that translational motion of the pull body 500 along the longitudinal axis L1 of the handle results in axial displacement of the outer sleeve 244 relative to the handle. This axial displacement may be used, for example, to axially displace the outer sleeve 244 relative to a corresponding actuator driver 248, thereby releasing the actuator driver 248 from the prosthetic heart valve.

[0104] 24A-24D, the pull body 500 has an axial axis L3 parallel to the longitudinal axis L1 of the handle. The pull body 500 includes a first pull body member 504 having a plurality of elongated sockets 508 parallel to the axial axis L3 of the pull body 500. Each of the sockets 508 can receive an actuation tube 512 (only two sockets 508 that receive actuation tubes 512 are shown in FIGS. 24A-24C). The number of sockets 508 can correspond to the number of actuation assemblies 220 of the delivery device 200. For example, if the delivery device 200 has six actuation assemblies 220, the pull body 500 can have six sockets 508. The sockets 508 are located on a side of the first pull body member 504 that faces the gear box 300.

[0105] The first pull body member 504 may include a pair of slider arms 516 extending in a direction parallel to the handle longitudinal axis L1 (and parallel to the pull body axial axis L3) and toward the gearbox 300. Relative to one another, the slider arms 516 are in a transversely (e.g., radially) spaced and opposed relationship to the handle longitudinal axis L1. Each guide arm 516 terminates in a hooked end 522 having opposed stop surfaces 522a, 522b, which may be oriented transversely to the longitudinal axis L1 / axial axis L3. As shown in FIG. 24A, the slider arms 516 may be disposed in respective guide slots 392 of the release housing 380 of the gearbox housing 304. Each slider arm 516 may move longitudinally within each guide slot 392 in a direction parallel to the handle longitudinal axis L1. Opposing stop surfaces 522a, 522b of the hooked end 522 of the slider arm 516 can engage opposing stop surfaces 393, 394 of each guide slot 392 to limit movement of the slider arm 516 in a proximal or distal direction. For example, when the stop surface 522a of the hooked end 522 abuts the stop surface 393, further movement of the slider arm 516 in the proximal direction is prevented (as shown in FIG. 24F). Similarly, when the stop surface 522b of the hooked end 522 abuts the stop surface 394, further movement of the slider arm 516 in the distal direction is prevented (as shown in FIG. 24E). The distance between the end walls 393, 394 and / or the length of the slider arm 516 can be configured to allow for a desired displacement of the pull body 500 and attached outer sleeve 244.

[0106] The first pull body member 504 may include a pair of guide beams 520 extending axially in a direction parallel to the handle longitudinal axis L1 (and parallel to the axial axis L3 of the pull body 500). Relative to one another, the guide beams 520 are laterally (e.g., radially) spaced apart and in opposing relationship to the handle longitudinal axis L1. As shown in FIG. 24A , the guide beams 520 may be disposed in respective guide channels 395 in the release housing 380 of the gearbox housing 304. Each guide beam 520 may move longitudinally within its respective guide channel 395 in a direction parallel to the handle longitudinal axis L1 as the slider arm 516 moves longitudinally within its respective guide slot 392.

[0107] The pull body 500 includes a second pull body member 524 disposed adjacent (e.g., distally in the illustrated example) to the first pull body member 504. The second pull body member 524 may be attached to the first pull body member 504 by fasteners or other suitable methods, such as welding, adhesives, etc. In some cases, the first pull body member 504 and the second pull body member may be formed (e.g., molded) as a single, integral component. The second pull body member 524 includes a central hub 528 having a longitudinal axis aligned with the longitudinal axis L3 of the pull body 500. The second pull body member 524 includes a plurality of radial arms 532 extending from the central hub 528 around the periphery of the pull body 500. The radial arms 532 are angularly spaced apart or angularly offset from one another around the axial axis L3 of the pull body 500. Each radial arm 532 includes a pin 536 that projects from the outer periphery of the pull body 500. The pins 536 are angularly spaced about the axial axis L3 of the pull body 500 or are angularly offset from one another by the radial arms 532 being angularly spaced about the axial axis L3 of the pull body 500.

[0108] The second pull body member 524 has a number of openings 540 that correspond to the number and location of the number of sockets 508 of the first pull body member 504, whereby the actuation tubes 512 may extend through the openings 540 and into the sockets 508. As further shown in FIG. 24D , each actuation tube 512 may have a key 542 (e.g., a radial protrusion on the outer diameter of the actuation tube) that is received in a slot 544 formed in the socket 508 to prevent rotation of the actuation tube 512 within the socket 508 (i.e., the actuation tube 512 is rotationally fixed relative to the pull body 500).

[0109] 24E and 24F, the first pull body member 504 and the second pull body member 524 have aligned openings 546, 547 to receive a guide rod 548. The guide rod 548 extends into an opening in the release housing 380 of the gearbox housing 304 and, together with the slider arm 516 and guide beam 520, maintains longitudinal alignment of the pull body 500 and the gearbox 300 as the slider arm 516 moves within each slot 392 in the release housing 380 of the gearbox housing 304.

[0110] 24D and 24G, the outer sleeve 244 of each actuation assembly 200 extends from a distal end of the actuation tube 512 into one lumen 513 of the actuation tube 512. The outer sleeve 244 is fixedly attached (e.g., using a set screw 513) to each actuation tube 512 such that the outer sleeve 244 can move when the pull body 500 moves. The actuator rod 248 associated with the outer sleeve 244 extends through the outer sleeve 244 and into a release housing 380 of the gearbox housing 304. The actuator rod 248 can be secured to a coupling section 403 (e.g., as shown in FIG. 18 ) attached to the release housing 380 to couple the actuator rod 248 to the gearbox 300. In an example, the coupling section 403 is connected to a connector shaft 402, which can be coupled to a torque limiter 401. The torque limiter 401 is coupled to one of the output gears 344 of the gearbox 300. If the handle does not use a torque limiter, the connector shaft 402 may be coupled directly to each of the output gears 344.

[0111] 24G, the outer sleeve 244 may not extend through the entire lumen 513 of the actuation tube 512. In this embodiment, the support extension tube 552 may extend from the coupling section 403 into a portion of the lumen 513 of the actuation tube 512 not occupied by the outer sleeve 244 to provide support to the proximal end portion 512a of the actuation tube 512 suspended from the pull body 500. The support extension tube 552 may be fixedly attached to the coupling section 403 but slidable relative to the actuation tube 512 such that the actuation tube 512 can translate on the support extension tube 552 toward or away from the coupling section 403 as the slider arm 516 moves along the slot 392 of the release housing 380 of the gearbox housing 304. In this embodiment, each actuation driver 248 extends through a respective outer sleeve 244, through a portion of the lumen 513 of the actuation tube 512 between the outer sleeve 244 and the support extension tube 522, through the support extension tube 552, through the coupling section 403, and into the connector shaft 402 (as shown in FIG. 24G).

[0112] 25A and 25B, the second knob 268 can have an inner surface 271 that forms a cylindrical bore 269. In an example, the cylindrical bore 269 defines a central axis L6 that is oriented parallel to the longitudinal axis L1 of the handle when the second knob 268 is mounted on the handle body (e.g., as shown in FIGS. 8 and 23). Cam slots 270 are formed in the inner surface 271 of the second knob 268 that defines the bore 269. The number of cam slots 270 can match the number of pins 536 of the pull body 500. The cam slots 270 may be rotationally offset from one another around the central axis L6 of the second knob 268 (e.g., in the case of three cam slots 270, the center points of the cam slots 270 may be 120 degrees apart) such that when the second knob 268 is positioned around the pull body 500 (as shown in FIG. 23), each pin 536 may extend into a corresponding cam slot 270.

[0113] 25B, each cam slot 270 can have an angled portion 270a and a lateral portion 270b, 270c at either end of the angled slot portion 270a. The angled slot portion 270a can extend along a path that is angled relative to the central axis L6. For example, the angled slot portion 270a can extend along a helical path. In one example, the path along which the angled slot portion 270a extends, or the inclination angle of the angled slot portion 270a relative to the central axis L6, can be configured such that movement of the pin 536 within and along the angled slot portion 270a produces movement of the pull body 500 in a direction parallel to the longitudinal axis L1 of the handle (or the central axis L6 of the second knob 268).

[0114] Each pin 536 can slide into the horizontal slot portion 270b, 270c of the respective cam slot 270 when the pull body 500 reaches the end of its proximal or distal travel. As shown in FIGS. 4A, 8, and 23, the handle 204 can include a safety knob 276 that can slide into a slot of the second knob 268 to prevent the second knob 268 from rotating relative to the handle body. The safety knob 268 can be used to limit the rotation of the second knob 268 relative to the body of the handle 204, thereby preventing or reducing the possibility of accidental release of the actuation assembly 220 from the prosthetic heart valve 100. In one example, the second knob 268 can be configured such that the safety knob 276 can slide into a receiving slot of the second knob 268 when the pin 536 is in either of the horizontal slot portions 270b, 270c. In some embodiments, the safety knob (which may also be referred to as a "safety switch") may be biased (e.g., with a biasing member such as a spring) toward an engaged / locked position with the second knob 268. When the safety knob 276 is removed from a receiving slot in the second knob 268 (e.g., by sliding the safety knob 276 distally), the second knob 268 may be rotated such that the pin 536 may be displaced into the angled slot portion 270a.

[0115] As the second knob 268 rotates relative to the handle body, the pin 536 slides along the cam slot 270. As the pin 536 slides along the angled slot portion 270a of the cam slot 270, the pull body 500 translates along the longitudinal axis L1 of the handle. FIG. 7C shows the outer sleeve 244 engaging the frame 104 of the prosthetic heart valve 100 and covering the flexible elongated element 254 (shown in FIG. 7B) of the actuator driver 248. To release the actuation assembly 220 from the prosthetic heart valve 100 (e.g., after radially expanding the prosthetic heart valve 100 at the implantation position), the outer sleeve 244 must be released from the frame 104 and also from covering the flexible elongated element 254 of the actuator driver 248. Both actions can be achieved by axially displacing the outer sleeve 244 relative to the handle. For example, the second knob 268 can be rotated in a direction to move the pull body 500 proximally (i.e., toward the gear box 300). Because the outer sleeve 244 is attached to the pull body 500, the outer sleeve 244 is displaced axially in a direction along the longitudinal axis L1 of the handle and toward the proximal end of the handle. The axial displacement of the outer sleeve 244 can withdraw the outer sleeve 244 from the frame 104 and from the flexible elongated element 254, allowing the flexible elongated element 254 (shown in FIGS. 7A-7B ) of the actuator driver 248 to be released from the actuator head 176 of the prosthetic heart valve 100.

[0116] During expansion of the prosthetic heart valve 100, rotational movement of the actuator driver 248 by operation of the gear box 300 applies a torque to the prosthetic heart valve 100 tending to rotate the prosthetic heart valve about the longitudinal axis L of the prosthetic heart valve. Because the outer sleeve 244 engages the frame 104 of the prosthetic heart valve 100, the outer sleeve 244 tends to rotate about the longitudinal axis L of the prosthetic heart valve 100. Because the pull body 500 is coupled to the outer sleeve 244, the pull body 500 likewise tends to rotate with the outer sleeve 244.

[0117] The gearbox 300 can pivot about a longitudinal axis L1 of the handle, which is aligned with the axial axis of the input shaft 324 and the axial axis of the guide rod 548. Thus, rotation of the pull body 500 during expansion of the prosthetic heart valve 100 can result in pivoting of the gearbox 300 about the longitudinal axis L1 of the handle 204. In some embodiments, the handle 204 includes a mechanism for limiting pivoting of the gearbox 300, at least during expansion of the prosthetic heart valve 100. In one example, the mechanism can include a stop member that engages with the gearbox housing 304 when the gearbox housing 304 is in a predetermined rotational position relative to the body of the handle 204.

[0118] 21A, 21B, 22C-22E, the gearbox housing 304 may have an extension arm 356 that protrudes from an outer surface of the gearbox housing 304. When the gearbox housing 304 is positioned within the cavity 205 of the handle 204, the extension arm 356 extends into a portion of the cavity 205 that surrounds the gearbox housing 304 (as shown in FIG. 21A). In one example, the extension arm 356 may be a flat member that lies in a plane transverse to the longitudinal axis L1 of the handle. The protruding member 360 may be attached to the extension arm 356 or may be integrally formed therewith. The protruding member 360 may be in the form of a rod or pin. The protruding member 360 may have a rounded end 359 for contacting a stop member. The protruding member 360 may be oriented transverse to the longitudinal axis L1 of the handle. The extension arm 356 can position the protruding member 360 such that the axial axis L4 (shown in FIG. 22E) of the protruding member 360 is tangential to a circular path 361 about the pivot axis of the gearbox 300 (or the longitudinal axis L1 of the handle). This can also be described as the protruding member 360 being radially outward of the pivot axis of the gearbox 300. Thus, the protruding member 360 moves along the circular path 361 as the gearbox 300 pivots.

[0119] The extension arm 356 is shown as an integral part of the housing section 330 of the gearbox housing 304. However, the extension arm 356 can be an integral part of any of the other housing sections of the gearbox housing in other embodiments. Also, the extension arm 356 is shown at the top of the housing section 330. However, it can be located elsewhere in the housing section 330, provided that it positions the protruding member 360 along the circular path 361. Alternatively, the circular path can be larger or smaller than the circular path 361, as long as it is coaxial with the longitudinal axis L1 of the handle.

[0120] The stop member 352 may be attached to an inner surface of the proximal body portion 212 of the handle 204 (as shown in FIG. 21A ) such that the protrusion member 360 can contact the stop member 352 as the protrusion member 360 moves along the circular path 361. The stop member 352 may be positioned such that an axial axis L5 (as shown in FIG. 22E ) of the stop member 352 is also tangential to the circular path 361. Thus, as the protrusion member 360 moves along the circular path 361, the protrusion member 360 encounters the stop member 352. In one example, the stop member 352 may be positioned such that the stop member 352 acts to limit the pivoting of the gear box 300 when the first knob 264 (as shown in FIG. 21A ) is rotated in a direction to expand the prosthetic heart valve (e.g., in a clockwise direction when viewed from the proximal end of the handle).

[0121] In one example, the first knob 264 can be rotated in a direction to expand the prosthetic heart valve 100 (e.g., in a clockwise direction when viewed from the proximal end of the handle). When the prosthetic heart valve 100 is expanded, if the protruding member 360 is not yet in contact with the stop member 352, the entire gear box 300 can pivot about the longitudinal axis L1 of the handle (which is the same as the axial axis of the input shaft 324 shown in FIG. 21A ) in a direction toward the stop member 352. As the gear box 300 pivots, the protruding member 360 moves along a circular path 361 until the protruding member 360 encounters the stop member 352, which then prevents further pivoting of the gear box 300 in the same direction. While the protruding member 360 is in contact with the stop member 352, the gear train 308 can still be operated through rotation of the first knob 264 and the input shaft 324.

[0122] In one example, the stop member 352 may be a load cell (or force sensor) that can measure any load applied by the protruding member 360 to the stop member 352 during expansion of the prosthetic heart valve when the protruding member 360 is in contact with the stop member 352 (as shown more clearly in FIG. 21B; the stop member 352 is shown in FIG. 21B without the handle body to which it is coupled for ease of illustration). This measured load can be used to determine the torque applied to the prosthetic heart valve 100 during expansion of the valve. For example, the measured load can be multiplied by the moment arm, as defined by the extension arm 356. Thus, the load cell implemented stop member 352 can perform the functions of limiting the pivoting of the gear box 300 and measuring the torque applied to the prosthetic heart valve 100. The load cell can be provided in dimensions significantly smaller than those of conventional torque meters, allowing for a more compact handle design.

[0123] When the first knob 264 is rotated in a direction to compress the prosthetic heart valve 100 (e.g., in a counterclockwise direction when viewed from the proximal end of the handle), the protruding member 360 is spaced from the stop member 352. In this manner, the stop member 352 does not act to limit the pivoting of the gear box 300 and does not measure torque when the prosthetic heart valve 100 is being compressed. In some cases, the handle body may act to limit the pivoting of the gear box 300 during compression of the prosthetic heart valve 100. For example, as shown in FIG. 26 , the proximal body portion 212 of the handle 204 may include an inner protrusion 213 that engages with the gear box 300 when the gear box 300 pivots in a direction R3 corresponding to compression of the prosthetic heart valve (e.g., in a counterclockwise direction when viewed from the proximal end of the handle, or in a clockwise direction when viewed from the distal end of the handle). In some cases, the gearbox 300 may include a second extension arm and protruding member, and a second load cell (or multi-directional load sensor) may be mounted on the handle body. The protruding member on the second extension arm may be positioned to contact the second load cell to measure the torque applied to the prosthetic heart valve 100 while compressing the prosthetic heart valve.

[0124] 1-26, the prosthetic heart valve 100 may be placed in a radially compressed configuration, and the actuation assembly 220 of the delivery device 200 may be releasably coupled to the actuator 168 of the prosthetic heart valve 100. The delivery device 200 and prosthetic heart valve 100 may be advanced over a guidewire through the patient's vasculature to a selected implantation location (e.g., the native aortic valve annulus). For example, if the prosthetic heart valve 100 is to be implanted within a native aortic valve, the delivery device 200 and prosthetic heart valve 100 may be inserted into and through the femoral artery and through the aorta to the native aortic valve. The prosthetic heart valve 100 may then be deployed to the implantation location.

[0125] In one example, the prosthetic heart valve 100 is enclosed within a delivery capsule 226 prior to insertion into the patient's vasculature. In this case, the third knob 272 can be operated to withdraw the delivery capsule 226 and expose the prosthetic heart valve 100. To deploy the prosthetic heart valve 100, the physician can rotate the first knob 264 to rotate a first set of actuator drivers (e.g., 248a, 248b, 248c) in a first direction and a second set of actuator drivers (e.g., 248d, 248e, 248f) in a second direction, which corresponds to counter-rotation of the first and second sets of actuators of the prosthetic heart valve 100 in directions that radially expand the prosthetic heart valve 100.

[0126] During valve expansion, the torque applied to the native anatomy can be measured via the stop member / load cell 352 of the handle 204. During valve expansion, the torque limiter(s) 400 can stop the gearbox 300 if the respective actuator driver(s) 248 are overloaded. After the prosthetic heart valve 100 is expanded to an operating diameter by rotation of the actuator, the actuation assembly 220 can be released from the prosthetic heart valve 100. To release the actuation assembly 220, the pull body 500 can be translated proximally (e.g., by rotating the second knob 268) along the longitudinal axis L1 of the handle 204 to pull the outer sleeve 244 from the frame 104 of the prosthetic heart valve 100 and the flexible extended element 254 of the actuator driver 248. The released flexible elongated element 254 may be detached from the actuator head 176 of the prosthetic heart valve 100, allowing the delivery device to be withdrawn from the body.

[0127] Any of the systems, devices, apparatus, etc. herein can be sterilized (e.g., using heat, radiation, and / or chemicals, etc.) to ensure that they are safe for use in patients, and any of the methods herein can include sterilization of the associated system, device, apparatus, etc. as one of the steps of the method. 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.

[0128] The treatment techniques, methods, processes, etc. described or suggested in this specification or the references incorporated herein may be performed on living animals or on non-living simulations such as cadavers, cadaver hearts, anthropomorphic ghosts, simulators (e.g., simulated using body parts, tissues, etc.). Further Examples

[0129] Additional embodiments based on the principles described herein are described below. Additional embodiments within the scope of the subject matter may be constructed, for example, by taking one feature of an embodiment alone, taking multiple features of an embodiment in combination, or combining one or more features of one embodiment with one or more features of one or more other embodiments.

[0130] Example 1: A delivery device for a prosthetic heart valve, the delivery device comprising: a handle body having a cavity and defining a longitudinal axis; a pull body disposed within the cavity and movable along the longitudinal axis within the cavity; an actuation assembly comprising a sleeve member disposed within the cavity and having an end portion coupled to the pull body such that movement of the pull body along the longitudinal axis axially displaces the sleeve member relative to the handle body; and a knob rotatably mounted on the handle body and operably coupled to the pull body such that rotation of the knob relative to the handle body moves the pull body within the cavity and along the longitudinal axis.

[0131] Example 2: A delivery device according to any of the embodiments described herein, particularly example 2, wherein the pull body defines an axial axis oriented parallel to the longitudinal axis and includes at least one pin member disposed radially relative to the axial axis and protruding from a periphery of the pull body.

[0132] Example 3: A delivery device according to any of the embodiments described herein, particularly example 2, wherein the knob includes a cam slot, the knob being disposed around a periphery of the pull body such that the pin member extends into the cam slot.

[0133] Example 4: A delivery device according to any of the embodiments described herein, particularly example 3, wherein the knob includes an inner surface forming a cylindrical lumen, the cylindrical lumen defining a central axis oriented parallel to the longitudinal axis, and the cam slot is formed in the inner surface and includes an angled slot portion.

[0134] Example 5: A delivery device according to any of the embodiments described herein, particularly example 4, wherein the angled slot portion is configured such that when the pin member moves along the angled slot portion, the pull body moves in a direction parallel to the longitudinal axis.

[0135] Example 6: A delivery device according to any of the embodiments described herein, particularly example 1, wherein the pull body defines an axial axis oriented parallel to the longitudinal axis and includes a plurality of pin members arranged radially relative to the axial axis, the pin members being rotationally offset about the axial axis and projecting from a periphery of the pull body.

[0136] Example 7: A delivery device according to any of the embodiments described herein, particularly example 6, wherein the knob includes an inner surface forming a cylindrical bore having a central axis, the knob includes a plurality of cam slots formed in the inner surface and rotationally offset from one another about the central axis, and the knob is disposed around a periphery of the pull body such that each of the pin members extends into one of the cam slots.

[0137] Example 8: A delivery device according to any of the embodiments described herein, particularly example 7, wherein each of the cam slots includes an angled slot portion extending along a path that is angled relative to the central axis.

[0138] Example 9: Any of the embodiments described herein, particularly example 8, further specifying that the central axis is oriented parallel to the longitudinal axis and each path is configured such that when the pin member moves along the angled slot portion of the respective cam slot, the pull body moves in a direction parallel to the longitudinal axis.

[0139] Example 10: A delivery device for a prosthetic heart valve, comprising: a handle body having a first end, a second end, a cavity between the first end and the second end, and a longitudinal axis extending through the first end, the cavity, and the second end; an actuator driver having a first driver end portion disposed within the cavity and a second driver end portion disposed outside the cavity, and a first axial axis extending through the first driver end portion and the second driver end portion; and a sleeve member operably coupled to the actuator driver. 11. A delivery device comprising: a sleeve member, the sleeve member having a first sleeve end portion disposed within the cavity, a second sleeve end portion disposed outside the cavity, and a second axial axis extending through the first sleeve end portion and the second sleeve end portion, the second axial axis being parallel to the first axial axis; and a pull body disposed within the cavity and coupled to the first sleeve end portion, the pull body being movable along the longitudinal axis such that movement of the pull body axially displaces the sleeve member relative to the handle body.

[0140] Example 11: A delivery device according to any of the examples described herein, particularly example 10, wherein the sleeve member is disposed around the actuator driver.

[0141] Example 12: A delivery device according to any of the embodiments described herein, particularly example 10 or example 11, wherein the sleeve member is coaxial with the actuator driver.

[0142] Example 13: A delivery device as described in any of the embodiments described herein, particularly any one of embodiments 10-12, wherein the second driver end portion includes an engagement member that releasably couples the actuator driver to an actuator of the prosthetic heart valve.

[0143] Example 14: A delivery device according to any of the embodiments described herein, particularly example 13, wherein the sleeve member is extendable over the engagement member and retractable from the engagement member by movement of the pull body along the longitudinal axis.

[0144] Example 15: A delivery device according to any of the embodiments described herein, particularly embodiment 13 or 14, wherein the engagement member comprises a central protrusion and one or more flexible elongated elements disposed about the central protrusion.

[0145] Example 16: A delivery device as described in any of the embodiments described herein, particularly any one of embodiments 10-15, further comprising a gearbox disposed within the cavity and coupled to the actuator driver for rotation of the actuator driver.

[0146] Example 17: A delivery device according to any of the embodiments described herein, particularly example 16, wherein the gearbox includes a gearbox housing enclosing a gear train, and the pull body is movably coupled to the gearbox housing.

[0147] Example 18: A delivery device according to any of the embodiments described herein, particularly example 17, further comprising a knob coupled to the pull body, wherein rotation of the knob relative to the handle body moves the pull body along the longitudinal axis.

[0148] Example 19: Any embodiment described herein, particularly example 18, wherein the pull body includes a first pull body portion, a second pull body portion, and a third axial axis extending through a center of the first pull body portion and a center of the second pull body portion, the third axial axis being parallel to the longitudinal axis.

[0149] Example 20: A delivery device according to any of the embodiments described herein, particularly example 19, wherein the first pull body portion includes a pin member disposed radially relative to the third axial axis and positioned on the periphery of the pull body, the knob including a cam slot, and the knob disposed about the periphery of the pull body such that the pin member extends into the cam slot.

[0150] Example 21: A delivery device according to any of the embodiments described herein, particularly example 20, wherein the knob includes an inner surface forming a cylindrical lumen, the cylindrical lumen defining a fourth axial axis oriented parallel to the longitudinal axis, and the cam slot includes an angled slot portion formed in the inner surface and extending along a path angled with respect to the fourth axial axis.

[0151] Example 22: A delivery device as described in any of the embodiments described herein, particularly embodiment 20 or 21, wherein the first pull body portion comprises a central hub and radial arms protruding from the central hub, and the pin member is formed at an end of the radial arms.

[0152] Example 23: A delivery device according to any of the embodiments described herein, particularly embodiments 19-22, wherein the second pull body portion includes a socket extending in a direction parallel to the third axial axis, and the first pull body portion includes an opening forming an extension of the socket.

[0153] Example 24: Any of the embodiments described herein, particularly example 23, further comprising an actuation tube extending through the opening and socket, the sleeve member being rigidly coupled to the actuation tube, and the actuation tube being rotationally fixed relative to the pull body.

[0154] Example 25: A delivery device according to any of the embodiments described herein, particularly example 19, wherein the first pull body includes a plurality of pin members disposed radially relative to the third axial axis and positioned on a periphery of the pull body, the pin members being angularly offset from one another.

[0155] Example 26: A delivery device according to any of the embodiments described herein, particularly example 25, wherein the knob includes a plurality of cam slots, the knob being disposed about the pull body such that each of the pin members is received in one of the cam slots.

[0156] Example 27: A delivery device according to any of the embodiments described herein, particularly example 26, wherein the knob includes an inner surface forming a cylindrical bore, the cylindrical bore defining a fourth axial axis, and each of the cam slots includes an angled slot portion formed in the inner surface and extending along a path angled with respect to the fourth axial axis.

[0157] Example 28: A delivery device described in any of the examples described herein, particularly any one of Examples 25-27, wherein the first pull body portion includes a central hub and a plurality of radial arms projecting from the central hub and angularly offset from one another, and each of the pin members is formed at an end of one of the radial arms.

[0158] Example 29: A delivery device described in any of the embodiments described herein, particularly any one of embodiments 25 to 28, further comprising additional actuator drivers and additional sleeve members, each additional sleeve member being operably coupled to one of the additional actuator drivers.

[0159] Example 30: A delivery device according to any of the embodiments described herein, particularly example 29, wherein the second pull body portion includes a plurality of sockets extending in a direction parallel to the third axial axis, and the first pull body portion includes a plurality of openings, each of the openings forming an extension of one of the sockets.

[0160] Example 31: A delivery device as described in any of the embodiments described herein, particularly example 30, further comprising a plurality of actuation tubes, each of which extends through one of the sockets and corresponding openings, each of the sleeve member and additional sleeve member being rigidly coupled to one of the actuation tubes, and each of the actuation tubes being rotationally fixed relative to the pull body.

[0161] Example 32: Any embodiment described herein, particularly example 31, wherein for each of the sockets and actuation tubes extending through the sockets, one of the sockets and each actuation tube includes a key and the other of the sockets and each actuation tube includes a slot, the key and the slot cooperating to prevent rotation of the actuation tube within the socket.

[0162] Example 33: A delivery device according to any of the embodiments described herein, particularly any one of embodiments 19 to 32, wherein the second pull body portion comprises a pair of slider arms projecting in a direction parallel to the third axial axis and spaced apart from each other in a direction transverse to the third axial axis.

[0163] Example 34: A delivery device according to any of the embodiments described herein, particularly example 33, wherein each slider arm comprises an end portion having a pair of opposing surfaces oriented transversely to the third axial axis.

[0164] Example 35: A delivery device described in any of the examples described herein, particularly any one of Examples 33-34, wherein an end portion of the gearbox housing includes a pair of slots extending in a direction along the longitudinal axis, and the pair of slider arms extend into the pair of slots and are movable along the pair of slots in response to movement of the pull body along the longitudinal axis.

[0165] Example 36: A delivery device according to any of the embodiments described herein, particularly example 35, wherein each of the slots in the gearbox housing includes a pair of opposing stop surfaces spaced along the longitudinal axis and positioned to selectively engage and stop movement of the slider arm in a predetermined direction.

[0166] Example 37: A delivery device described in any of the examples described herein, particularly any one of Examples 33-36, wherein the second pull body portion includes a pair of guide beams that protrude in a direction along the third axial axis and are spaced apart from each other in a direction transverse to the third axial axis.

[0167] Example 38: A delivery device according to any of the embodiments described herein, particularly example 37, wherein the pair of guide beams are oriented perpendicular to the pair of slider arms.

[0168] Example 39: A delivery device described in any of the examples described herein, particularly any one of examples 37-38, wherein an end portion of the gearbox housing includes a pair of channels extending in a direction along the longitudinal axis, and the pair of guide beams extend into the pair of channels and are movable along the pair of channels in response to movement of a pull body along the longitudinal axis.

[0169] Example 40: A delivery device according to any of the embodiments described herein, particularly any one of embodiments 19 to 39, wherein the pull body includes a first opening extending in a direction along the third axial axis, the gearbox housing includes a second opening extending in a direction along the longitudinal axis, and further includes a guide rod extending through the first and second openings.

[0170] Example 41: 1. A delivery assembly comprising: a prosthetic heart valve having a frame and at least one actuator coupled to the frame and operable to move the frame between a radially expanded configuration and a radially compressed configuration; a handle comprising a handle body having a cavity and defining a longitudinal axis; an actuator driver configured to releasably engage the at least one actuator; a sleeve member operably coupled to the actuator driver and movable between a first position in which the actuator driver is held in engagement with the at least one actuator and a second position in which the actuator driver is released from engagement with the at least one actuator; a pull body disposed within the cavity and coupled to an end portion of the sleeve member, the pull body being movable along the longitudinal axis such that movement of the pull body axially displaces the sleeve member between the first position and the second position; and a knob rotatably mounted on the handle body, the knob operably coupled to the pull body such that rotation of the knob relative to the handle body moves the pull body along the longitudinal axis.

[0171] Example 42: A delivery assembly according to any of the embodiments described herein, particularly example 41, wherein the prosthetic heart valve further comprises a valve structure disposed within and coupled to a frame.

[0172] Example 43: A delivery assembly described in any of the examples described herein, particularly any one of Examples 41-42, wherein the pull body defines an axial axis oriented parallel to the longitudinal axis, and the pull body comprises at least one pin member disposed radially relative to the axial axis and protruding from a periphery of the pull body.

[0173] Example 44: A delivery assembly as described in any of the embodiments described herein, particularly example 43, wherein the knob includes a cam slot and the knob is disposed around the periphery of the pull body such that the pin member extends into the cam slot.

[0174] Example 45: A delivery assembly according to any of the embodiments described herein, particularly example 44, wherein the knob includes an inner surface forming a cylindrical bore, the cylindrical bore defining a central axis oriented parallel to the longitudinal axis, and the cam slot includes an angled slot portion formed in the inner surface and extending along a path angled relative to the central axis.

[0175] Example 46: A delivery assembly according to any of the embodiments described herein, particularly example 45, wherein the path is configured such that as the pin member moves along the slot portion, the pull body moves in a direction parallel to the central axis.

[0176] Example 47: A delivery assembly described in any of the embodiments described herein, particularly any one of embodiments 41 to 46, further comprising a gear box disposed within the cavity and coupled to the actuator driver for rotation of the actuator driver.

[0177] Example 48: A delivery assembly according to any of the embodiments described herein, particularly example 47, wherein the pull body is movably coupled to the gear box.

[0178] Example 49: A method of implanting a prosthetic heart valve, the method comprising: engaging an end portion of an actuator driver coupled to a handle with an end portion of an actuator coupled to a frame of the prosthetic heart valve; moving a pull body in a first direction along a longitudinal axis of the handle to extend an end portion of a sleeve member coupled to the pull body over the engaged end portions of the actuator driver and actuator; delivering the prosthetic heart valve to an implantation location; radially expanding the prosthetic heart valve to a functional size; moving the pull body in a second direction along the longitudinal axis of the handle opposite the first direction to pull the end portion of the sleeve member from the engaged end portions of the actuator driver and actuator; and releasing the end portion of the actuator driver from the end portion of the actuator.

[0179] Example 50: The method of any of the examples described herein, particularly example 49, wherein each movement of the pull body along the longitudinal axis of the handle includes rotating a knob operably coupled to the pull body.

[0180] Although the subject matter has been described with a selection of implementations and examples, these preferred implementations and examples should not be taken as limiting the scope of the subject matter, as many other implementations and examples are possible that are within the scope of the subject matter. The scope of the claimed subject matter is defined by the claims.

Claims

1. 1. A delivery device for a prosthetic heart valve, the delivery device comprising: a handle body having a first end, a second end, a cavity between the first end and the second end, and a longitudinal axis extending through the first end, the cavity, and the second end; an actuator driver having a first driver end portion disposed within the cavity, a second driver end portion disposed outside the cavity, and a first axial axis extending through the first driver end portion and the second driver end portion; a sleeve member operably coupled to the actuator driver, the sleeve member having a first sleeve end portion disposed within the cavity, a second sleeve end portion disposed outside the cavity, and a second axial axis extending through the first sleeve end portion and the second sleeve end portion, the second axial axis being parallel to the first axial axis; a pull body disposed within the cavity and coupled to the first sleeve end portion, the pull body being movable along the longitudinal axis such that movement of the pull body axially displaces the sleeve member relative to the handle body.

2. 2. The delivery device of claim 1, wherein the second driver end portion comprises an engagement member for releasably coupling the actuator driver to an actuator of the prosthetic heart valve, and the sleeve member is extendable over and retractable from the engagement member by movement of the pull body along the longitudinal axis.

3. 3. The delivery device of claim 1 or 2, further comprising a gearbox disposed within the cavity and coupled to the actuator driver for rotation thereof, the gearbox comprising a gearbox housing enclosing a gear train, the pull body being movably coupled to the gearbox housing.

4. The delivery device of claim 3 , further comprising a knob coupled to the pull body, wherein rotation of the knob relative to the handle body moves the pull body along the longitudinal axis.

5. 5. The delivery device of claim 4, wherein the pull body comprises a first pull body portion, a second pull body portion, and a third axial axis extending through a center of the first pull body portion and a center of the second pull body portion, the third axial axis being parallel to the longitudinal axis.

6. 6. The delivery device of claim 5, wherein the first pull body portion comprises a pin member disposed radially relative to the third axial axis and positioned on a periphery of the pull body, the knob comprising a cam slot, and the knob disposed about the periphery of the pull body such that the pin member extends into the cam slot.

7. 7. The delivery device of claim 6, wherein the knob has an inner surface forming a cylindrical lumen, the cylindrical lumen defining a fourth axial axis oriented parallel to the longitudinal axis, and the cam slot comprises an angled slot portion formed in the inner surface and extending along a path angled with respect to the fourth axial axis.

8. 8. The delivery device of claim 6 or 7, wherein the first pull body portion comprises a central hub and radial arms projecting from the central hub, the pin members being formed at ends of the radial arms.

9. 9. The delivery device of any one of claims 6-8, wherein the second pull body portion comprises a socket extending in a direction parallel to the third axial axis, and the first pull body portion comprises an opening forming an extension of the socket.

10. 10. The delivery device of claim 9, further comprising an actuation tube extending through the opening and socket, the sleeve member being rigidly coupled to the actuation tube, the actuation tube being rotationally fixed relative to the pull body.

11. 6. The delivery device of claim 5, wherein the first pull body comprises a plurality of pin members disposed radially relative to the third axial axis and positioned on a periphery of the pull body, the pin members being angularly offset from one another.

12. The delivery device of claim 11 , wherein the knob includes a plurality of cam slots, the knob being disposed about the pull body such that each of the pin members is received in one of the cam slots.

13. 13. The delivery device of claim 12, wherein the knob includes an inner surface forming a cylindrical bore, the cylindrical bore defining a fourth axial axis, and each of the cam slots includes an angled slot portion formed in the inner surface and extending along a path angled with respect to the fourth axial axis.

14. 14. The delivery device of any one of claims 11 to 13, wherein the first pull body portion comprises a central hub and a plurality of radial arms projecting from the central hub and angularly offset from one another, each of the pin members being formed at an end of one of the radial arms.

15. A delivery device according to any one of claims 11 to 14, further comprising additional actuator drivers and additional sleeve members, each additional sleeve member operably coupled to one of the additional actuator drivers.

16. 16. The delivery device of claim 15, wherein the second pull body portion comprises a plurality of sockets extending in a direction parallel to the third axial axis, and the first pull body portion comprises a plurality of openings, each of the openings forming an extension of one of the sockets.

17. 17. The delivery device of claim 16, further comprising a plurality of actuation tubes, each of the actuation tubes extending through one of the sockets and corresponding openings, each of the sleeve member and additional sleeve member rigidly coupled to one of the actuation tubes, and each of the actuation tubes being rotationally fixed relative to the pull body.

18. 18. The delivery device of any one of claims 7 to 17, wherein the second pull body portion comprises a pair of slider arms projecting in a direction parallel to the third axial axis and spaced apart from one another in a direction transverse to the third axial axis.

19. each slider arm including an end portion having a pair of opposing surfaces oriented transversely to the third axial axis; an end portion of the gearbox housing including a pair of slots extending in a direction along the longitudinal axis, the pair of slider arms extending into the pair of slots and movable along the pair of slots in response to movement of the pull body along the longitudinal axis; 20. The delivery device of claim 18, wherein each of the slots in the gearbox housing comprises a pair of opposing stop surfaces spaced along the longitudinal axis and positioned to selectively engage and stop movement of the slider arm in a predetermined direction.

20. the second pull body portion includes a pair of guide beams projecting in a direction along the third axial axis and spaced apart transversely to the third axial axis; 20. The delivery device of any one of claims 5 to 19, wherein an end portion of the gearbox housing includes a pair of channels extending in a direction along the longitudinal axis, and the pair of guide beams extend into the pair of channels and are movable along the pair of channels in response to movement of the pull body along the longitudinal axis.

21. 21. The delivery device of any one of claims 5-20, wherein the pull body comprises a first opening extending in a direction along the third axial axis, and the gearbox housing comprises a second opening extending in a direction along the longitudinal axis, and further comprising a guide rod extending through the first opening and the second opening.

22. 1. A method of implanting a prosthetic heart valve, comprising: engaging an end portion of an actuator driver coupled to a handle with an end portion of an actuator coupled to a frame of the prosthetic heart valve; moving a pull body in a first direction along a longitudinal axis of the handle to extend an end portion of a sleeve member coupled to the pull body over the engaged end portions of the actuator driver and actuator; delivering the prosthetic heart valve to an implantation location; radially expanding the prosthetic heart valve to a functional size; moving the pull body in a second direction along the longitudinal axis of the handle opposite the first direction to pull the end portion of the sleeve member from the engaged end portions of the actuator driver and actuator; and releasing the end portion of the actuator driver from the end portion of the actuator.

23. 23. The method of claim 22, wherein each of the moving the pull body along the longitudinal axis of the handle comprises rotating a knob operably coupled to the pull body.

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