DELIVERY DEVICE FOR IMPLANTING A PROSTHETIC HEART VALVE - Patent application

Abstract

A delivery device for a prosthetic heart valve includes a handle, one or more actuator drivers, and a gearbox disposed within the handle and coupled to rotate the actuator drivers relative to the handle. The gearbox may include a counter-rotating gear train that may be operated to rotate the two sets of actuator drivers in opposite directions. One or more of the actuator drivers may have an associated torque limiter that prevents overloading of the actuator driver. The gearbox may be pivotally mounted within the handle. The gearbox may be configured to engage a stop member within the handle to limit pivoting of the gearbox in a predetermined direction. The handle may include a sensor positioned to measure torque applied to the prosthetic heart valve during rotation of the actuation driver.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 63 / 420,166, filed October 28, 2022, and U.S. Provisional Patent Application No. 63 / 282,463, filed November 23, 2021, both of which are incorporated by reference herein.

[0002] FIELD OF THE DISCLOSURE The present disclosure relates to prosthetic devices, such as prosthetic heart valves, and further to delivery devices and methods for implanting prosthetic heart valves. [Background technology]

[0003] The human heart can be affected by various valvular diseases. These valvular diseases can cause serious dysfunction of the heart, and ultimately, it may be necessary to repair the native valve or replace the native valve with an artificial valve. There are several known repair devices (e.g., stents) and artificial valves, and several known methods for implanting these devices and valves in humans. Percutaneous and minimally invasive surgical approaches can be used in various procedures to deliver artificial medical devices to locations in the body that are not easily accessible by surgery or where it is desirable to access them without surgery.

[0004] In one embodiment, the prosthetic heart valve can be mounted in a crimped state on the distal end of a delivery device and advanced through the patient's vascular system (e.g., through the femoral artery and aorta) to reach the prosthetic heart valve at an implantation site within the heart. The prosthetic heart valve is then expanded to its functional size, for example, by inflating a balloon on which the prosthetic valve is mounted and activating a mechanical actuator that applies an expansive force to the prosthetic heart valve, or by deploying the prosthetic heart valve from a sheath of the delivery device so that the prosthetic heart valve can 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. Mechanically expandable prosthetic heart valves may offer one or more advantages over self-expandable and balloon-expandable prosthetic heart valves. For example, mechanically expandable prosthetic heart valves may be expanded to a variety of diameters. Mechanically expandable prosthetic heart valves may also be compressed after initial expansion (e.g., for repositioning and / or retrieval). Summary of the Invention [Problem to be solved by the invention]

[0006] A delivery device and method for implanting a prosthetic heart valve are described herein. The disclosed delivery device and method can, for example, reduce the obstacles and / or time required to implant a prosthetic heart valve. The disclosed delivery device is relatively simple and easy to use, and includes various safeguards that can help ensure that the prosthetic heart valve is safely and securely implanted. [Means for solving the problem]

[0007] A delivery device for a prosthetic heart valve may include a handle and a shaft assembly coupled to the handle. The delivery device may further include one or more actuation assemblies that may be used to releasably couple the prosthetic heart valve to the shaft assembly and radially expand and / or compress the prosthetic heart valve.

[0008] In some examples, a delivery device for a prosthetic heart valve may be summarized as including: a handle having a proximal end, a distal end, and a cavity extending from the proximal end to the distal end; a first actuator driver having a proximal end portion disposed within the cavity and a distal end portion extending out of the cavity; a second actuator driver having a proximal end portion disposed within the cavity and a distal end portion extending out of the cavity; and a gear train disposed within the cavity and coupled to the proximal end portions of the first and second actuator drivers and configured to simultaneously rotate the first and second actuator drivers in opposite directions.

[0009] In some examples, a delivery device for a prosthetic heart valve may be summarized as including a handle having a longitudinal axis and a cavity extending along the longitudinal axis; a set of first actuator drivers, each first actuator driver having a proximal end portion disposed within the cavity and a distal end portion extending out of the cavity; a set of second actuator drivers, each second actuator driver having a proximal end portion disposed within the cavity and a distal end portion extending out of the cavity; a first drive gear coupled to the first actuator driver and configured to rotate the first actuator driver in a first direction; and a second drive gear coupled to the second actuator driver and configured to rotate the second actuator driver in a second direction opposite the first direction.

[0010] In some examples, the prosthetic heart valve may be summarized as including a frame having an inflow end, an outflow end, and a longitudinal axis extending from the inflow end to the outflow end and movable between a radially expanded configuration and a radially compressed configuration, a first actuator coupled to the frame at a first location, and a second actuator coupled to the frame at a second location spaced from the first location along a circumference of the frame, wherein rotating the first actuator in a first rotational direction and rotating the second actuator in a second rotational direction opposite the first rotational direction causes the frame to move between the radially expanded configuration and the radially compressed configuration.

[0011] In some examples, the delivery assembly may be summarized as including a prosthetic heart valve comprising a frame having an inflow end, an outflow end, and a longitudinal axis extending from the inflow end to the outflow end and movable between a radially expanded configuration and a radially compressed configuration, a first actuator coupled to the frame at a first location, and a second actuator coupled to the frame at a second location spaced apart from the first location along a circumference of the frame. The delivery assembly comprises a handle having a proximal end, a distal end, and a cavity extending from the proximal end to the distal end, a first actuator driver having a proximal end portion disposed within the cavity and a distal end portion extending out of the cavity and removably coupled to the first actuator, a second actuator driver having a proximal end portion disposed within the cavity and a distal end portion extending out of the cavity and removably coupled to the second actuator, and a gear train disposed within the cavity and coupled to the proximal end portions of the first and second actuator drivers and configured to simultaneously rotate the first and second actuator drivers in opposite directions.

[0012] In some embodiments, a delivery device for a prosthetic heart valve may be summarized as including a handle having a cavity, a gearbox disposed within the cavity and including at least one output shaft and a gear coupled thereto, an actuator driver having a predetermined torque limit range, and a rotatable assembly coupling the at least one output shaft to the actuator driver, the rotatable assembly having a first rotational state in which the at least one output shaft and the actuator driver rotate together about a longitudinal axis, and a second rotational state in which the at least one output shaft and the actuator driver do not rotate together about the longitudinal axis, the first rotational position corresponding to when a torque applied to the actuator driver is below the predetermined torque limit range, and the second rotational position corresponding to when a torque applied to the actuator driver is within the predetermined torque limit range.

[0013] In some embodiments, a delivery device for a prosthetic heart valve may be summarized as including a handle having a cavity, a gearbox disposed within the cavity and including a plurality of output shafts and a plurality of output gears coupled thereto, a plurality of actuator drivers, each actuator driver having a predetermined torque limit range, and a plurality of rotatable assemblies, each rotatable assembly coupled at a first end to one of the output shafts and at a second end to one of the actuator drivers. Each rotatable assembly includes a first rotatable body, a second rotatable body, and a rotational biasing member coupling the first rotatable body to the second rotatable body. The rotational biasing member biases the first rotatable body and the second rotatable body to a position where the first rotatable body and the second rotatable body rotate together about the longitudinal axis when a torque applied to the actuator driver is below the predetermined torque limit range. The rotational biasing member enables relative rotation between the first rotatable body and the second rotatable body about the longitudinal axis when a torque applied to the actuator driver is within a predetermined torque limit range.

[0014] In some examples, a delivery device for a prosthetic heart valve may be summarized as including a handle body having a longitudinal axis, a gear box mounted within the handle body and rotatable about the longitudinal axis, and a stop member coupled to the handle body and positioned to limit rotation of the gear box about the longitudinal axis when the gear box is rotated in a predetermined direction.

[0015] In some examples, a delivery device for a prosthetic heart valve may be summarized as including a handle body having a longitudinal axis, a load cell coupled to the handle body and having a first axial axis positioned tangentially to a circular path about the longitudinal axis, and a gearbox having a protruding member pivotally mounted about the longitudinal axis and with a first axial axis positioned tangentially to the circular path, the protruding member configured to contact the load cell when the gearbox is pivoted in a predetermined direction corresponding to movement of the gearbox to expand the prosthetic heart valve.

[0016] In some examples, a delivery device for a prosthetic heart valve can be summarized as including an actuator driver, a gearbox having at least one output shaft, an engagement member coupled to the at least one output shaft and rotatable about a longitudinal axis with the at least one output shaft and having a first engagement surface and a first locking surface spaced apart along the longitudinal axis, a driver member coupled to the actuator driver and rotatable about the longitudinal axis and having a second engagement surface in opposing relationship with the first engagement surface and engaging with the first engagement surface, and a base member rotationally fixed relative to the longitudinal axis and having a second locking surface in opposing relationship with the first locking surface, wherein the engagement member is axially displaceable along the longitudinal axis in response to a torque of the actuator driver between a first position where the first locking surface is separated from the second locking surface and a second position where the first locking surface is interlocked with the second locking surface, the second position corresponding to a condition where the torque of the actuator driver exceeds a threshold value.

[0017] In some embodiments, a delivery device for a prosthetic heart valve includes a handle having a cavity, a gearbox disposed within the cavity and having at least one output shaft, an actuator driver extending into the cavity, a torque limiter coupling the actuator driver to the at least one output shaft, the torque limiter including an engagement member coupled to the at least one output shaft and rotatable about a longitudinal axis in response to rotation of the at least one output shaft, the engagement member including a set of engagement teeth at a first end and a first set of locking teeth at a second end spaced from the first end, the engagement member being rotatable about a longitudinal axis in response to rotation of the at least one output shaft, the engagement member including a set of engagement teeth at a first end and a first set of locking teeth at a second end spaced from the first end, the torque limiter being rotatable about a longitudinal axis and configured to engage the actuator. and a torque limiter comprising: a driver member coupled to the actuator driver and having a set of driver teeth in opposing relationship with and slidably engaging with the set of engagement teeth; and a base member rotationally fixed relative to the longitudinal axis and having a second set of locking teeth in opposing relationship with the first set of locking teeth, wherein the engagement member is axially displaceable along the longitudinal axis in response to a torque of the actuator driver, and the engagement member is axially displaceable to engage the first set of locking teeth with the second set of locking teeth when the torque of the actuator driver exceeds a threshold value.

[0018] In some embodiments, the method may be summarized as including: coupling the prosthetic heart valve to at least one actuator driver of a delivery device, where an engagement member is movably coupled to the at least one actuator driver and fixedly coupled to an output shaft of a gearbox of the delivery device, where the engagement member is axially displaceable along a longitudinal axis between the at least one actuator driver and a base member that is rotationally fixed relative to the longitudinal axis in response to a torque of the at least one actuator driver; and rotating the output shaft of the gearbox to rotate the at least one actuator driver in a first direction to radially expand the prosthetic heart valve to an operating diameter, where rotation of the output shaft is automatically stopped by engagement of the engagement member with the base member if a torque of the at least one actuator driver exceeds a threshold value. [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 the distal end portion of the delivery apparatus with a prosthetic heart valve in a radially expanded configuration coupled thereto. [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 the actuation assembly of the delivery device. [Figure 7A] FIG. 7A is a perspective view of the actuation assembly of the delivery device aligned with the actuator of the prosthetic heart valve. [Figure 7B] FIG. 7B is a perspective view of an actuation assembly that engages the 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 the 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 in transparency. [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 gear box. [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 perpendicular to the longitudinal axis of the handle. [Figure 11] FIG. 11 is another perspective view of the prosthetic heart valve without the valve 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 and a delivery device in a radially expanded configuration. [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. [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 shown in FIG. 13B. [Figure 17B] FIG. 17B is a cross-sectional view of the torque limiter taken generally along line 17B-17B shown in FIG. 13B. [Figure 18] FIG. 18 is a cross-sectional view of a torque limiter disposed within a housing. [Figure 19] 19 is a cross-sectional view of the torque limiter in the housing taken along line 19-19 shown in FIG. [Figure 20A] 20A and 20B show the approximation of the arms of a torsion spring during twisting of the torsion spring. [Figure 20B]Same as above. [Figure 21A] FIG. 21A is a cross-sectional view of the proximal end portion of the handle showing the load cell mounted 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 shown in FIG. 22B. [Figure 22E] FIG. 22E is a cross-sectional view of the gearbox housing taken along line 22E-22E shown in FIG. 22B. [Figure 22F] FIG. 22F is a cross-sectional view of the gearbox housing taken along line 22F-22F shown in FIG. 22B. [Figure 22G] FIG. 22G is a cross-sectional view of the gearbox housing taken along line 22G-22G shown in FIG. 22B. [Fig. 22H] FIG. 22H is a cross-sectional view of the gearbox housing taken along line 22H-22H shown in 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 shown in 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 shown in FIG. 24A. [Figure 24F] FIG. 24F is a cross-sectional view of a portion of the handle taken along a plane extending along line 24F-24F shown in 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 shown in FIG. 25A. [Figure 26] FIG. 26 is a cross-sectional view of the handle taken along line 26-26 shown in FIG. 4A. [Figure 27A] FIG. 27A is a cross-sectional view of a torque limiter for an actuator driver according to some embodiments in a locked state. [Figure 27B] FIG. 27B is a cross-sectional view of the torque limiter of FIG. 27A in an unlocked state. [Figure 28A] FIG. 28A is a perspective view of a driver member of the torque limiter of FIGS. 27A and 27B. [Figure 28B] FIG. 28B is a perspective view of an engagement member of the torque limiter of FIGS. 27A and 27B. [Figure 28C] FIG. 28C is a schematic diagram of the forces between opposing tooth flanks of the driver member of FIG. 28A and the engagement member of FIG. 28B. [Figure 29A] FIG. 29A is a perspective view of a torque limiter for an actuator driver, according to some embodiments. [Figure 29B] FIG. 29B is a detail view showing the tooth geometry of the engagement member and driver member of the torque limiter of FIG. 29A. [Figure 29C]FIG. 29C is a cross-sectional view of the torque limiter taken along line 29C-29C shown in FIG. 29A. [Figure 30A] 30A-30D show the transition of the state of the torque limiter of FIG. 29A during the transition from an unlocked state to a locked state. [Figure 30B] 30A-30D show the transition of the state of the torque limiter of FIG. 29A during the transition from an unlocked state to a locked state. [Figure 30C] 30A-30D show the transition of the state of the torque limiter of FIG. 29A during the transition from an unlocked state to a locked state. [Figure 30D] 30A-30D show the transition of the state of the torque limiter of FIG. 29A during the transition from an unlocked state to a locked state. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0020] General Considerations

[0021] The subject matter of the invention is described by 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 restriction, 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 deemed to apply if the element appears in another figure with the same or similar reference characters. In some cases, the term "corresponding to" may be used to describe the correspondence between elements of different figures. In exemplary usage, 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 deemed to have the characteristics of the other element in the second figure, and vice versa, unless otherwise stated.

[0023] The word "comprise" and variations thereof, such as "comprises" and "comprising," should be construed in an open-ended, inclusive sense, i.e., "including, but not limited to." The singular forms "a," "an," "at least one," and "the" include plural referents unless the context dictates otherwise. The term "and / or," when used between the last two elements of a list, means any one or more of the listed elements. The term "or" is generally used in its broadest sense, i.e., meaning "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 "plural," when used with an element, means two or more of the elements. Directions and other relative references (e.g., medial and lateral, upper and lower, upward and downward, left and right, and proximal and distal) may be used to facilitate review 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] Overview of 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 that can be manipulated to radially expand or radially compress the prosthetic heart valve. The delivery device may include an actuator driver for releasably engaging and manipulating 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 while manipulating 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 may 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 may be disposed within the handle to engage and limit the rotation of the gear box during expansion of the prosthetic heart valve. In some examples, the stop member may 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 gearbox once the torque applied to the actuator driver falls within a predetermined maximum torque tolerance.

[0031] Examples of the disclosed technology

[0032] FIG. 1 illustrates a prosthetic heart valve 100 according to some embodiments. 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 may be radially compressed for delivery to an implantation site within a patient's body and then radially expanded to a working diameter at the implantation site. 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 supported within and coupled to the frame 104.

[0033] In embodiments, the valve structure 108 includes one or more leaflets 112 that are made of a flexible material and configured to open and close to regulate blood flow. In some embodiments, the valve structure 108 may include three leaflets 112 that may be arranged to be folded in a tricuspid configuration. The leaflets 112 may be made in whole or in part from 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 some embodiments, the support posts 124, 128 may be disposed 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 adjacent support posts 124, 128 and interconnecting the 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 commissure windows 140 may be formed in one or more of the support posts 124. A commissure 144 may be formed in the commissure windows 140 to couple 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 suture 154) and / or to selected struts 132 of the frame 104 (e.g., using suture 156).

[0036] In some examples, frame 104 may be adjusted between a radially expanded configuration and a radially compressed configuration by deflecting posts 132. In some examples, frame 104 (e.g., the posts and posts) may be made of a biocompatible, plastically expandable material that may allow frame 104 to be adjustable between a radially expanded configuration and a radially compressed configuration. Suitable examples of plastically expandable materials that may be used to form 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 some embodiments, one or more actuators 168 may be coupled to the support posts 128 and may be used to adjust the frame 104 between a radially expanded configuration and a radially compressed configuration. In some embodiments, each support post 128 may include an upper post member 160 and a lower post member 164 (the terms "upper" and "lower" being 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 may be operable to increase or decrease the gap G to radially compress or expand the frame 104.

[0038] In some embodiments, the actuator 168 may include an actuator rod 172 with an actuator head 176 attached thereto. In the embodiment shown in FIGS. 2A and 2B, the actuator rod 172 extends through or into the post members 160, 164 and across the gap G. In the embodiment shown in FIG. 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 on the outflow apex of the upper post member 160. In the embodiment shown in FIG. 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 on 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 may include a nut 180 with internal threads to threadably engage the actuator rod 172. In this case, the actuator rod 172 may be translated longitudinally by rotating the actuator rod 172 relative to the nut 180. In some embodiments, the actuator rod 172 may be freely slidable relative to the top post member 160. In other embodiments, the actuator rod 172 may be threadably engaged with the top post member 160.

[0040] 3, the actuator head 176 may include a pair of protrusions 184 that form a slot 188. The actuator head 176 may further include one or more shoulders 192. As described in further detail herein, an actuation assembly of the delivery device may removably engage the actuator head 176 via the slot 188 and shoulders 192.

[0041] 2A and 2B, in one situation, the actuator rod 172 can 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 can have the effect of radially expanding the frame 104. In another situation, the lower post member 164 can be held steady 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 can have the effect of radially compressing the frame 104. To avoid over-crimping the prosthetic heart valve, a stopper 185 (e.g., a nut) can be placed on the actuator rod 172 to limit the movement of the actuator rod 172 while rotating the actuator rod 172 to radially compress the frame 104.

[0042] In alternative implementations, as described further herein, some of the actuator rods 172 may be rotated in one direction while the other actuator rod 172 is simultaneously rotated in the opposite direction to either radially expand the frame or radially compress the frame. This counter-rotation of the actuator rods may 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 Patent Application No. PCT / US2021 / 052745 and U.S. Provisional Patent Application No. 63 / 209904, which are incorporated by reference herein.

[0044] 4A and 4B show a delivery device 200, according to some embodiments, that 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 may be used to removably couple the prosthetic heart valve 100 to a distal end portion of the shaft assembly 208 and 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 site, a delivery device 200 (and / or other crimping devices) may be used to move the prosthetic heart valve 100 from a radially expanded configuration to a radially compressed delivery configuration. An actuation driver of the actuation assembly 220 may manipulate the actuator 168 of the prosthetic heart valve 100, once in the implantation position, to radially expand the prosthetic heart valve 100 to an working diameter.

[0046] In some embodiments, 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 (uniformly or non-uniformly) about a central axis of the multi-lumen delivery shaft 228 and disposed about the lumen 234.

[0048] In some embodiments, 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 (as 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 (as shown in FIG. 4B ). The prosthetic heart valve 100 may be disposed about the distal end portion of the nosecone shaft 232 when it is removably coupled to the actuation assembly 220.

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

[0050] 6 illustrates a distal end portion of the actuation assembly 220. Each actuation assembly 220 may include an outer sleeve 244 and an actuator driver 248 extending through the outer sleeve 244. In an embodiment, the actuator driver 248 includes a distal head having a central projection 252 and one or more flexible elongate elements 254. The central projection 252 may 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 elongate elements 254 may have a radial projection 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. The distal end portion of the actuator driver 248 is then 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. When 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 distally 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, radially compressing 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 further advanced 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 the proximal end portions of the upper post members 160 of the respective support posts 128 when the actuation assembly 220 is coupled to the respective actuators 168. The engagement of the support extensions 260 with the frame 104 can counteract rotational forces applied to the frame 104 by the actuator rod 172 during expansion of the frame 104.

[0054] A variety of other coupling mechanisms may be used to releasably couple the prosthetic heart valve to the working assembly of the delivery device. For example, additional coupling mechanisms are described in International Patent Application No. PCT / US2022 / 031257 and U.S. Patent Application No. 63 / 319,702, 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 some embodiments, the handle 204 may include a first knob 264, a second knob 268, and a third knob 272. In some embodiments, the knobs 264, 268, 272 may be rotatable 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 an embodiment, 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 embodiments, 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 a working diameter). In some embodiments, 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, preventing the second knob 268 from rotating. Retracting the safety knob 276 from the recess can allow the second knob 268 to rotate.

[0058] In an embodiment, 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 causes the outer delivery shaft 224 to move axially relative to the actuation assembly 220, the prosthetic heart valve 100, and the nosecone shaft 232.

[0059] In some embodiments, a delivery capsule 226 (shown in FIG. 4B ) may be attached to a distal end of the outer delivery shaft 224. Distal axial movement of the outer delivery shaft 224 relative to the other shafts and the prosthetic valve may 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. Proximal axial movement of the outer delivery shaft 224 relative to the other shafts and the prosthetic valve may retract the delivery capsule 226 from the prosthetic heart valve 100, exposing the prosthetic heart valve, for example, for deployment at an implantation site. In some embodiments, the third knob 272 may be operably coupled to a carriage 280 within 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, moment forces may be applied to the frame 104 due to the rotation of the actuators 168, i.e., due to frictional forces acting between the frame 104 and the actuator rods 172 of the actuators 168. These moment forces may, 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 may be split into two sets, which may be rotated in opposite directions such that the moment forces due to one set of actuators are counterbalanced by the moment forces due to the other set of actuators. This may, for example, help the frame 104 to remain rotationally fixed, or at least substantially rotationally fixed, during expansion of the prosthetic heart valve. Thus, this configuration may, for example, make the 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 with 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 rotates the actuator driver 248, which in turn rotates the actuator 168 of the prosthetic heart valve 100. In some embodiments, 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 embodiment, the gear train 308 includes an input shaft 324 and an input gear 320 coupled to the input shaft 324. In some embodiments, the input shaft 324 is aligned with a longitudinal axis L1 of the handle 204 (as shown in FIG. 8). The input shaft 324 may be coupled to the first knob 264 of the handle 204 such that rotation of the first knob 264 rotates the input shaft 324 (as shown in FIG. 8). The input gear 320 rotates with the input shaft 324. The rotation direction R1 of the input gear 320 may be clockwise or counterclockwise depending on the direction in which the first knob 264 is rotated.

[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. The teeth of the input gear 320 mesh with the 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 some embodiments, when the input gear 320 rotates in a first direction R1, the transmission gear 328 is driven 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, in response to driving the transmission gear 328 by the input gear 320, rotation of the transmission shaft 332 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 as the first drive gear 336 rotates, the second drive gear 340 is driven. 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 embodiment, the set of first 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 some embodiments, 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 some embodiments, 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 R3 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 some embodiments, 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 with actuators 168a, 168b, 168c, 168d, 168e, and 168f coupled to support posts 128a, 128b, 128c, 128d, 128e, and 128f, respectively. In some embodiments, a first set of actuators may include actuators 168a, 168b, and 168c, and a second set of actuators may include actuators 168d, 168e, and 168f. The first set of actuators 168a, 168b, 168c may be coupled to a first set of actuator drivers 248a, 248b, 248c, as shown in FIG. 12, and the 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 apparatus are not shown in FIG. 12, e.g., the body of the handle 204 and the outer delivery shaft 224 through which the multi-lumen delivery shaft 228 extends are not shown).

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

[0070] Other embodiments in which the actuators are divided into two sets are also possible. 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 a set). In this case, actuator rods 172a, 172c, 172e of the first set of actuators may have threads with a first configuration (e.g., right-handed threads), and actuator rods 172b, 172d, 172f of the second set of actuators may have threads with a second configuration opposite the first configuration (e.g., left-handed 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 more actuators than 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] 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 a respective actuator 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 a respective actuator 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 knob 264 can be used to rotate the first set of actuator drivers 248a, 248b, 248c and the second set of actuator drivers 248d, 248e, 248f in opposite directions. The opposite rotation of the two sets of actuator drivers causes the first set of actuators 168a, 168b, 168c and the second set of actuators 168d, 168e, 168f to rotate in opposite directions. This opposite rotation of the two sets of actuators can advantageously help reduce the possibility of the prosthetic heart valve rotating relative to the native 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 of 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 some examples, the torque limiters limit the rotation of the corresponding actuator driver 248 if the torque of 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 if any of the actuator drivers 248 are stopped by a torque limiter.

[0075] 13A and 13B show a torque limiter 400 according to some embodiments. 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 of 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 of 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 some embodiments, the maximum torque of 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 shows 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 a respective torque limiter 400.

[0076] Returning to Figures 13A and 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 embodiment, the second rotatable body 408 is positioned distal to the first rotatable body 408, 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 embodiment, 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 some embodiments, 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 such that the first rotatable body 404 is rotatable with the output shaft 346. In some embodiments, 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 as the input shaft 346 rotates, the first rotatable body 404 rotates. 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 having “flat”), which may engage a similarly D-shaped (or “flat”) output shaft 346 such that the first rotatable body 404 may be rotatable 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, gluing, or other means for a fixed connection) such that the first rotatable body 404 is rotatable therewith.

[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 to the distal axial bore 416 of the first rotatable body 404. The connector shaft 402 may engage the second rotatable body 408 in a manner such that the connector shaft 402 is rotatable therewith. For example, the axial bore 420 may have a non-circular profile to engage 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 such that the second rotatable body 408 is rotatable therewith. 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 embodiments, the opposing ends of the connector shaft 402 and the output shaft 346 may axially overlap. In such embodiments, the shafts 402, 346 may include one or more features that facilitate alignment of the connector shaft 402 with 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 cases, 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. Thus, 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) may rotate relative to one another.

[0082] In an embodiment, 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 opposite 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 some embodiments, 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 can be 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 can be 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 to the distal axial bore 416.

[0084] The coil portion 426 of the torsion spring 424 may be disposed within a 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 of the rotatable bodies 404, 408 may 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 may engage surfaces 444a, 436a of respective receiving slots 444, 436 formed in the rotatable bodies 404, 408. The torsion spring 424 may 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 of the actuator driver 248 is within a predetermined torque limit range. In some cases, the torsion spring 424 may be preloaded, and the torsion spring 424 may begin to twist when the torque of the actuator driver 248 exceeds the preload of the torsion spring 424. The preload in the torsion spring 424 may be set as the lower limit of the predetermined range. The upper limit of the predetermined range may be the predetermined torque limit of the actuator driver 248, and the lower limit of the predetermined range may be less than the predetermined torque limit of the actuator driver 248 (e.g., within 10-15% 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 may 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 recessed portions 448 may be formed on the outer surface 446 of the second rotatable body 408. In embodiments, each tapered recessed portion 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 may be curved in some embodiments.

[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 recessed portion 448 tapers radially (i.e., from deep to shallow) from the first radial shoulder 452 to the second radial shoulder 456. Each tapered recessed portion 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 some embodiments, two tapered recessed portions 448 are formed on the outer surface 446. The tapered recessed portions 448 are angularly spaced apart from each other about 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 recessed portions 448 may be such that the two tapered recessed portions are diametrically opposed about 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 recessed portion 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 the sections 374a-f shown in FIG. 22G) or may be a separate housing that is attached to the gearbox housing 304.

[0089] As shown more clearly in FIG. 19, each channel 468 receives a wedge member 472. In some embodiments, the wedge member 472 can be in the form of a longitudinal rod member. In some embodiments, the wedge member 472 is fixedly coupled to the first rotatable body 404 such that the wedge member 472 rotates with the first rotatable body 404. In some embodiments, a proximal portion of the wedge member 472 extends into a longitudinal bore 476 in 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. While the gear train 308 is operating, it 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 is also coupled to the second rotatable body 408 via the connector shaft 402 and 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 of 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 toward one another. FIG. 20A shows the angular spacing 429a between the end portions 428, 430 being smaller than the initial angular spacing 429 (shown in FIG. 19) due to the end portions 428, 430 moving closer together (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 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 is pressed against the narrow end of the channel 468 such that further rotational movement of the wedge member 472 within the tapered channel 468 is not possible due to interference between the surfaces 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, once 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, movement of the entire gear train 308 stops, preventing rotational movement of all other actuator drivers 248 coupled to the gear box 300.

[0093] In this manner, the torque limiter 400 may help ensure that the actuation members and / or prosthetic heart valve and / or other components of the delivery device are operated within predetermined torque limits, which may, 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 native annulus (and / or other natural tissue).

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

[0095] In some embodiments, as shown in FIGS. 22A-22D, the gearbox housing 304 can have a first housing section 310 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., to allow the proximal end portion of the input shaft 324 to be coupled to the first knob 264 (shown in FIG. 12)). The first housing section 368 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 fastening holes 326 (shown in FIG. 22C) that may receive fasteners, such as bolts, which may be used to fasten the first housing section 310 to other housing sections of the gearbox housing.

[0096] In some cases, 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 attach the encoder to the first housing section 310 around the respective output shaft. FIG. 22K shows an encoder 311 mounted on one of the output shafts. In some embodiments, the encoder 311 may include a sensing member capable of detecting the number of rotations of the output shaft. In some embodiments, the encoder may be a magnetic encoder including a magnetic sensor and a magnetic device to generate 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 some embodiments, as shown in FIGS. 22A-22E, the gearbox housing 304 can have a second housing section 330 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 be aligned 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 mounted in the compartment 312.

[0098] In some embodiments, as shown in FIGS. 22A, 22B, 22E, and 22F, the gearbox housing 304 can have a third housing section 358 disposed adjacent to the second housing section 330 and forming end walls of the central opening 348 and 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 the output shafts 346a-f (shown in FIGS. 10A-10C) when the output gears 344a-f (shown in FIGS. 10A-10C) are disposed within the compartments 350a-f of the second housing section 330. The third housing section 358 can include holes 366a and 366b for receiving the transmission shafts 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 mounted in 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 to receive fasteners.

[0099] 22A, 22B, and 22G, the gearbox housing 304 can have a fourth housing section 372 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 the respective hole 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 housed within the compartments 374a-f. The fourth housing section 372 may include a fastener hole 378 that may align with the fastener 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 some embodiments, 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 can form a distal end portion of the gearbox housing 304. The fifth housing section 380 can include a base member 381 forming 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 of the torque limiter 400 (shown in FIG. 18 ) 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 some embodiments, as shown in FIGS. 22A, 22B, and 22H-22J, the fifth housing section 380 may further include a guide member 389 protruding from the base member 381. The guide member 389 may include a hole 390 aligned with the hole 382 of the plate member 381 for receiving 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 FIG. 24E). 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 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 described further herein, the guide slots 392 and the guide channels 395 may 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 engaging a distal end portion (or fifth housing section) 380 of the gearbox housing 304. The second knob 268 may rotatably engage the pull body 500 such that rotation of the second knob 268 relative to the handle body produces 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 produces 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, pull body 500 has an axial axis L3 parallel to the longitudinal axis L1 of the handle. Pull body 500 includes a first pull body member 504 having a plurality of elongated sockets 508 axially aligned with the axial axis L3 of pull body 500. Each of sockets 508 may 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 may correspond to the number of actuation assemblies 220 of the delivery device. The sockets 508 are located on a side of first pull body member 504 that faces gearbox 300.

[0105] The first pull body member 504 may include a pair of guide arms 516 extending toward the gearbox 300 in a direction parallel to the handle longitudinal axis L1 (and parallel to the pull body axial axis L3). The guide arms 516 are spaced apart in a direction perpendicular to the handle longitudinal axis L1 and in opposing relationship. Each guide arm 516 terminates in a hooked end 522. As shown in FIG. 24A, the guide arms 516 may be disposed in respective guide slots 392 in the fifth housing section / distal end portion 380 of the gearbox housing 304. Each guide arm 516 may move within the respective guide slot 392 in a direction parallel to the handle longitudinal axis L1. The hooked ends 522 of the guide arms 516 have opposing surfaces 522a, 522b for engaging shoulders in the respective guide slots 392 to limit the movement of the guide arms 516 in a proximal or distal direction.

[0106] The first pull body member 504 may include a pair of guide members 520 extending in a direction parallel to the handle longitudinal axis L1 (and parallel to the axial axis L3 of the pull body 500). The guide members 520 are spaced apart in an opposing relationship in a direction perpendicular to the handle longitudinal axis L1. As shown in FIG. 24A, the guide members 520 may be disposed in respective guide channels 395 in the fifth housing section / distal end portion 380 of the gearbox housing 304. Each guide member 520 may move within its respective guide channel 395 in a direction parallel to the handle longitudinal axis L1 as the guide arm 516 moves longitudinally within its respective guide slot 392.

[0107] The pull body 500 includes a second pull body member 524 disposed adjacent to the first pull body member 504. The second pull body member 524 may be attached to the first pull body member 524 by fasteners or other suitable methods, such as welding, adhesives, etc. The second pull body member 524 includes a central hub 528 having an axial axis aligned with the axial 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 to the periphery of the pull body 500. The radial arms 532 are angularly spaced apart about the axial axis L3 of the pull body 500. Each radial arm 532 carries a pin 536 such that the pin 536 protrudes from the periphery of the pull body 500. The pins 536 are angularly spaced about the axial axis L3 of the pull body 500 by the radial arms 532 which are 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 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 tubes 512 are rotationally fixed relative to the pull body 500).

[0109] 24E , first pull body member 504 and second pull body member 524 have aligned openings 546, 547 for receiving guide rod 548. Guide rod 548 extends into an opening in the fifth housing section / distal end portion 380 of gearbox housing 304 and, together with guide arm 516 and guide member 520, maintains longitudinal alignment of pull body 500 with gearbox 300 as guide arm 516 moves within respective slots 392 in the fifth housing section / distal end portion 380 of gearbox housing 304.

[0110] As shown in FIGS. 24D and 24F , the lumen 513 of each actuation tube 512 receives a proximal end portion of the outer sleeve 244 of the actuation assembly 220. The outer sleeve 244 is fixedly attached (e.g., using a set screw) to the actuation tube 512. In some cases, the actuation tube 512 may not extend all the way to the coupling section 403 located at the distal end of the gearbox 300 (e.g., the coupling section 403 located adjacent to the compartment 374 or the housing 460 that holds the rotatable assembly 401 of the torque limiter 400, as shown in FIG. 18 ). In these cases, a support extension tube 552 may extend from the coupling section 403 into the lumen 513 of the actuation tube 512 to provide support to the proximal end portion of the actuation tube 512. The support extension tube 552 may be fixedly attached to the coupling section 403. The support extension tube 552 is not fixed 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 guide arm 516 moves along the slot 392 of the fifth housing section / distal end portion 380 of the gearbox 304. Each actuation driver 248 extends through a respective outer sleeve 244, through a lumen 513 of the actuation tube 512, through the support extension tube 552, to and is fixed to the connector shaft 402.

[0111] 25A and 25B, inner channels 270 are formed along an inner surface of second knob 268. The number of inner channels 270 may match the number of pins 536 of pull body 500. The number of inner channels 270 may be angularly spaced about central axis L6 of second knob 268 such that when second knob 268 is disposed about pull body 500 (as shown in FIG. 23), each pin 536 may extend into a corresponding inner channel 270. Each channel 270 may have a Z-shape (or S-shape), as shown in FIG. 25B.

[0112] When the second knob 268 is rotated, the pin 536 slides along the inner channel 270. As the pin 536 slides along the inner channel 270, the pull body 500 is translated along the longitudinal axis L1 of the handle. To release the actuation assembly 220 from the prosthetic heart valve 100 (e.g., after the prosthetic heart valve 100 has been radially expanded at the implantation site), the second knob 268 may be rotated in a direction that moves 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. Axial displacement of the outer sleeve 244 may cause the outer sleeve 244 to retract from the frame 104 and from the flexible elongated element 254, and the flexible elongated element 254 of the actuator driver 248 (shown in Figures 7A and 7B) may be released from the actuator head 176 of the prosthetic heart valve 100.

[0113] 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.

[0114] The gearbox 300 may 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, as the pull body 500 rotates during expansion of the prosthetic heart valve 100, the gearbox 300 may pivot about the longitudinal axis L1 of the handle 204. In some embodiments, the handle 204 includes a mechanism for limiting the pivoting of the gearbox 300, at least during expansion of the prosthetic heart valve 100. In some embodiments, the mechanism may include a stop member that engages the gearbox housing 304 when the gearbox housing 304 is in a predetermined rotational position relative to the body of the handle 204.

[0115] 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 some embodiments, the extension arm 356 may be a flat member that lies in a plane perpendicular to the longitudinal axis L1 of the handle. The protruding member 360 may be attached to or integrally formed with the extension arm 356. The protruding member 360 may be in the form of a rod or a pin. The protruding member 360 may have a rounded end 359 for contacting a stop member. The protruding member 360 may be oriented in a direction perpendicular to the longitudinal axis L1 of the handle. The extension arm 356 may position the protruding member 360 such that the axial axis L4 (as 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 may 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.

[0116] 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. The extension arm 356 is also shown at the top of the housing section 330. However, the extension arm can be located anywhere 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.

[0117] The stop member 352 may be mounted 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 may 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, the protrusion member 360 encounters the stop member 352 as the protrusion member 360 moves along the circular path 361. In some embodiments, the stop member 352 may be positioned such that the stop member 352 acts to limit the rotation 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).

[0118] In some embodiments, 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 has not yet contacted 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, as 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 contacts the stop member 352, the gear train 308 can still be operated through rotation of the first knob 264 and the input shaft 324.

[0119] In some embodiments, the stop member 352 may be a load cell (or force sensor) so that any load applied to the stop member 352 by the protruding member 360 may be measured when the protruding member 360 contacts the stop member 352 during expansion of the prosthetic heart valve (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 may be used to determine the torque applied to the prosthetic heart valve 100 during expansion of the valve. For example, the measured load may be multiplied by the moment arm defined by the extension arm 356. Thus, the stop member 352 implemented with a load cell may function to limit the rotation of the gearbox 300 and to measure the torque applied to the prosthetic heart valve 100. The load cell may be provided in dimensions significantly smaller than those of conventional torque meters, allowing for a more compact handle design.

[0120] 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. Thus, the stop member 352 does not act to limit the rotation of the gear box 300 and does not measure torque when the prosthetic heart valve 100 is compressed. In some cases, the handle body may act to limit the rotation 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 the gear box 300 when the gear box 300 rotates 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 be provided with 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 disposed to contact the second load cell to measure the torque applied to the prosthetic heart valve 100 while compressing the prosthetic heart valve.

[0121] 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 removably 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 site (e.g., the native aortic valve annulus). For example, when implanting the prosthetic heart valve 100 into the native aortic valve, the delivery device 200 and prosthetic heart valve 100 may be inserted into the femoral artery, through the femoral artery, and through the aorta to the native aortic valve. The prosthetic heart valve 100 may then be deployed at the implantation site.

[0122] In some embodiments, 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 may be manipulated to encase the delivery capsule 226 and expose the prosthetic heart valve 100. To deploy the prosthetic heart valve 100, the physician may 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.

[0123] During valve expansion, the torque applied to the native anatomy can be measured via the stop member / load cell 352 in the handle 204. During valve expansion, the torque limiter 400 can stop the gear box 300 if the respective actuator driver 248 is overloaded. After the prosthetic heart valve 100 is expanded to the working diameter by the 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 along the longitudinal axis L1 of the handle 204 (e.g., by rotating the second knob 268) to retract the outer sleeve 244 from the frame 104 of the prosthetic heart valve 100 and the flexible elongated element 254 of the actuator driver 248. The released flexible elongated element 254 can be detached from the actuator head 176 of the prosthetic heart valve 100, and the delivery device can be withdrawn from the body.

[0124] 27A and 27B illustrate a torque limiter 600, according to some embodiments. The torque limiter 600 may couple the actuator driver 248 to the output shaft 346 of the gearbox 300 (e.g., as shown in FIGS. 9A-9C) and may operate to prevent rotation of the actuator driver 248 if the torque of the actuator driver 248 exceeds a threshold value. In an unlocked state, as shown in FIG. 27A, the torque limiter 600 transmits rotation of the output shaft 346 to the actuator driver 248. In a locked state, as shown in FIG. 27B, rotation of the actuator driver 248 via the output shaft 346 is prevented. The torque limiter 600 transitions from the unlocked state to a locked state if the torque of the actuator driver 248 exceeds a threshold value, as described further below. The threshold value may be a maximum torque allowed by the actuator driver 248 (or within a tolerance of the maximum torque allowed by the actuator driver 248) while rotating the actuator driver 248 to rotate the prosthetic heart valve. Continued rotation of the actuator driver 248 at a torque above the maximum torque may cause damage to the actuator driver 248 and / or the prosthetic heart valve. If the torque of the actuator driver 248 exceeds a threshold, the torque limiter 600 is transitioned to a locked state to prevent continued operation of the actuator driver 248 above the maximum torque.

[0125] Torque limiter 600 includes a housing 620 having a longitudinal axis L7. Housing 620 can be a separate housing that can be attached to gearbox 300 or an integral section of gearbox housing 304 (e.g., as shown in Figures 9A-C).

[0126] The torque limiter 600 includes a driver member 608, an engagement member 612, and a base member 616. The driver member 608, the engagement member 612, and the base member 616 may be disposed within a chamber 622 of a housing 620 and axially aligned along a longitudinal axis L7 in some embodiments. The engagement member 612 is fixedly secured to the output shaft 346, is located between the driver member 608 and the base member 616, and is axially movable along the longitudinal axis L7. The driver member 608 is fixedly secured to the actuator driver 248. The driver member 608 and the engagement member 612 are rotatable about the longitudinal axis L7 relative to the housing 620. The base member 616 is rotationally fixed (e.g., via the housing 620) relative to the longitudinal axis L7.

[0127] The actuator driver 248 is attached to and rotates with the driver member 608. The output shaft 346 is attached to and rotates with the engagement member 612. The output shaft 346 may extend from the engagement member 612, through a hole in the base member 616, to the gear 344. The gear 344 is part of a gear train (e.g., gear train 308 shown in FIGS. 10A-10C).

[0128] In the unlocked state of the torque limiter 600 (as shown in FIG. 27A ), the engagement member 612 engages the driver member 608 and is separated from the base member 616 (e.g., by a gap G1). In the unlocked state, torque can be transmitted, for example, from the handle, through the gearbox, to the output shaft 346, and through the engagement member 612 and the driver member 608 to the actuator driver 248. If the torque generated by the actuator driver 248 (e.g., on the engagement member 612 via rotation of the driver member 608) exceeds a threshold value, the engagement member 612 can be displaced axially toward the base member 616 (as shown in FIG. 27B ) until the engagement member 612 engages the base member 616. At this point, the torque limiter 600 is in a locked state (or is locked), and the engagement member 612 can no longer be rotated relative to the driver member 608. Because the output shaft 346 is connected to the engagement member 612, when the torque limiter is in the locked state, the output shaft 346 is also prevented from rotating.

[0129] In some embodiments, due to the connections between the gears of the gearbox, if one or more of the torque limiters are locked, all actuator drivers are prevented from rotating. A locked torque limiter also prevents rotation of the actuation knob. Thus, in some embodiments, a handle for a delivery device may include one or more torque limiters regardless of whether the delivery device includes one or more actuator drivers. In some embodiments, a handle for a delivery device may include multiple torque limiters (e.g., one torque limiter for each actuator driver).

[0130] 28A, the driver member 608 of the torque limiter 600 may include a driver body 628. A proximal end face 630 of the driver body 628 includes a set of driver teeth 636 arranged along an axis perpendicular to the longitudinal axis L7. Each driver tooth 636 of the set of driver teeth 636 has opposing tooth flanks 636a, 636b. In some embodiments, the tooth flank 636a is an axial surface that extends in an axial direction defined by the longitudinal axis L7 (e.g., parallel to the longitudinal axis L7), and the tooth flank 636b is an inclined surface (e.g., inclined in the axial direction). In some embodiments, the tooth flank 636a may be an inclined surface (e.g., not extending parallel to the longitudinal axis L7). The tooth flanks 636a, 636b are joined at a cusp 638 having an angle α1.

[0131] The actuator driver 248 extends distally from a distal end of the driver body 628. The actuator driver 248 may be coupled to the driver body 628 using any suitable method, such as by inserting an end portion of the actuator driver 248 into a hole in the driver body 628 and securing the end portion to the hole via adhesive, fasteners, and / or other coupling means. In some examples, the actuator driver 248 and the driver member 608 may be integrally formed as a single, unitary component.

[0132] 28B, the engagement member 612 includes an engagement member body 640. A distal end surface 642 of the engagement member body 640 includes a set of engagement teeth 648 disposed about a longitudinal axis L7. Each engagement tooth 648 of the set of engagement teeth 648 has opposing tooth flanks 648a, 648b. In some embodiments, the tooth flank 648a is an axial surface extending in an axial direction defined by the longitudinal axis L7 (e.g., parallel to the longitudinal axis L7), and the tooth flank 648b is an inclined surface (e.g., inclined in the axial direction). In some embodiments, the tooth flank 648a can be an inclined surface (e.g., not extending parallel to the longitudinal axis L7). The tooth flanks 648a, 648b are joined at a tooth cusp 649 having an angle α2. In some embodiments, the angle α2 can be the same as the angle α1 (shown in FIG. 28A). In other embodiments, the angle α2 can be different from the angle α1. The inclined tooth flanks 636b, 648b can slide relative to one another as the engagement member 612 is displaced axially relative to the driver member 608.

[0133] The output shaft 346 extends proximally from the proximal end of the engagement member body 640. The output shaft 346 may be coupled to the engagement member body 640 using any suitable method (e.g., by inserting an end portion of the output shaft 346 into a bore in the engagement member body 640 and securing the end portion to the bore via adhesive, fasteners, and / or other coupling means). In some examples, the output shaft 346 and the engagement member 612 may be integrally formed as a single, unitary component.

[0134] 27A and 27B, in the torque limiter 600, the engagement member 612 is axially aligned with the driver member 608 and oriented such that the set of engagement teeth 648 is in opposing relationship with the set of driver teeth 636. In some embodiments, the set of engagement teeth 648 may be complementary to the set of driver teeth 636 in that the set of engagement teeth 648 may engage with the set of driver teeth 636 as shown in FIG. 27A and 27B. In some embodiments, the tooth profile of the engagement teeth 648 may be identical to the tooth profile of the driver teeth 636 (e.g., the angles α1 and α2 are identical and the inclination of the tooth flanks of the engagement teeth 648 and the driver teeth 636 are identical). In some embodiments, the tooth profile of engagement tooth 648 may be different from the tooth profile of driver tooth 636 (e.g., angles α1 and α2 may be different, or angles α1 and α2 may be the same but the slope of the tooth flanks of engagement tooth 648 and driver tooth 636 may be different).

[0135] In some examples, the torque limiter 600 may include a biasing member, shown as a spring 624 in FIGS. 27A and 27B, but may be a different type of biasing member (e.g., an elastically deformable member, a hydraulic piston, a pneumatic piston, etc.). The spring 624 (or biasing member) is configured to bias the engagement member 612 away from the base member 616 and against the driver member 608. In an unlocked state of the torque limiter 600, the spring 624 (or biasing member) may bias the engagement member 612 against the driver member 608 such that the set of engagement teeth 648 fully engages the set of driver teeth 636 (see, e.g., FIG. 27A). When the torque of the actuator driver 248 exceeds a threshold value, the engagement member 612 is moved axially away from the driver member 608 and the spring 624 (or biasing member) is compressed (see, e.g., FIG. 27B).

[0136] 28C shows the force components at the interface between opposing driver teeth 636 and engagement teeth 648. Force component F x acts in a direction parallel to the longitudinal axis L7 (or axial direction) and has a force component F θacts in a direction perpendicular to the longitudinal axis L7. The corresponding axial and tangential forces between the teeth 636, 648 can be expressed as: F θ =M / R (1) F x =KΔY (2) F τ (α)=F x / F θ (3)

[0137] In formulas (1) to (3), F x is the force component acting on the tooth in a direction parallel to the longitudinal axis L7 (or axial direction), and F θ is the force component acting on the tooth in a direction perpendicular to the longitudinal axis L7, M is the moment applied to the tooth by the actuator driver, R is the moment arm (e.g., the radial distance of the tooth from the longitudinal axis L7), and F T is the tangential force applied to the tooth, α is the angle between the tooth flanks, k is the spring constant of spring 624 (or the biasing constant of the biasing member), and ΔY is the distance that engagement member 612 (or set of engagement teeth 648) is displaced from driver member 608 (or from set of driver teeth 636). When the set of teeth 636, 648 is fully engaged (as shown in FIG. 27A), ΔY is zero.

[0138] 27A and 27B, a proximal end face 650 of the engagement member 612 includes a set of locking teeth 652. The base member 616 includes a base body 660. A distal end face 662 of the base body 660 includes a set of locking teeth 664 positioned in opposing relationship with, and may interlock with, the set of locking teeth 652 of the engagement member 612. In an unlocked state of the torque limiter 600, the set of locking teeth 652 of the engagement member 612 are separated from the set of locking teeth 664 of the base member 616 by a gap G1 (shown in FIG. 27A). This separation may be maintained by a spring 624 biasing the engagement member 612 toward the driver member 608. While the locking teeth 664, 652 are separated, the engagement member 612 can be rotated about the longitudinal axis L7 by the output shaft 346.

[0139] The base body 660 may include a proximal flange 668 that may be used to attach the base member 616 to the housing 620, which would prevent rotation of the base member 616 about the longitudinal axis L7 relative to the housing 620. The output shaft 346 may extend proximally from the engagement member 612 through a central opening or bore 661 in the base body 660. The spring 624 is disposed about a portion of the output shaft 346 between the engagement member 612 and the base member 616. One end of the spring 624 may be attached to the engagement member 612 while the other end of the spring 624 abuts a surface 666 of the base member 616 (or vice versa).

[0140] In the unlocked state of the torque limiter 600, the spring 624 is free and biases the engagement member 612 toward the driver member 608. In the unlocked state, the set of locking teeth 652 of the engagement member 612 is separated from the set of locking teeth 664 of the base member 616 by a gap G1 that allows the engagement member 612 (and output shaft 346) to freely rotate relative to the base member 616. The biasing force of the spring 624 may be relieved if the torque of the actuator driver 248 exceeds a threshold value. When this occurs, the engagement member 612 may be displaced axially toward the base member 616 until the set of locking teeth 652 of the engagement member 612 engage and interlock with the set of locking teeth 664 of the base member 616, as shown in FIG. 27B. Because the base member 616 is rotationally fixed, rotation of the engagement member 612 is prevented when the set of locking teeth 652 of the engagement member 612 is interlocked with the set of locking teeth 664 of the driver member 616. As a result, the driver member 608 and actuator driver 248, as well as the output shaft 346, are prevented from rotating relative to the base member 616. This may, for example, reduce the chance of an actuation shaft of a prosthetic heart valve being damaged.

[0141] In some examples, the angle α between the tooth flanks of the driver tooth 636 and the engagement tooth 648 (corresponding to α1 and α2 in FIGS. 28A and 28B ) and the spring constant k of the spring 624 can be selected to permit a displacement ΔY of the engagement member 612 in response to the torque M of the actuator driver 248 such that if the torque M exceeds a threshold value, the displacement ΔY of the engagement member 612 is sufficient to interlock the set of locking teeth 652 of the engagement member 612 with the set of locking teeth 664 of the base member 616, which will stop further rotation of the engagement member 612. The threshold value can be within a tolerance of the maximum torque that the actuator driver 248 can have (e.g., within 15% of the maximum torque). In some examples, the maximum torque of the actuator driver 248 can be 50 N-mm.

[0142] When the engagement member 612 stops rotating due to the interlocking of the sets of teeth 652, 664, the output shaft 346 and the gear 344 engaged to the output shaft 346 stop rotating. Because all gears within the gearbox 300 are interconnected (e.g., as shown in FIG. 10A), the entire gearbox will also stop, which may prevent rotational movement of all other actuator drivers coupled to the gearbox 300. Each of the actuator drivers coupled to the gearbox 300 may be provided with a torque limiter 600 such that once the torque of any one of the actuator drivers exceeds a threshold, the gearbox 300 may be stopped.

[0143] In some examples, the axial lengths H1, H2 (shown in FIG. 27A) of the set of engagement teeth 648 and the set of driver teeth 636 can be longer than the gap G1 (shown in FIG. 27A) between the set of locking teeth 652 and the set of locking teeth 664 in the unlocked state of the torque limiter 600. Thus, when the gap G1 is closed during interlocking of the set of locking teeth 652, 664 in the locked state of the torque limiter 600, as shown in FIG. 27B, the inclined tooth surface 648b of the set of engagement teeth 648 can remain engaged with the inclined tooth surface 636b of the set of driver teeth 636. The set of engagement teeth 648 and the driver teeth 636 engage with each other to prevent rotation of the actuator driver 248 while the set of locking teeth 652, 664 are interlocked with each other.

[0144] 29A illustrates a torque limiter 700, according to some embodiments. Similar to the torque limiter 600 described herein, the torque limiter 700 includes a driver member 708, an engagement member 712, and a base member 716 disposed within a cavity 722 of a housing 720 having a longitudinal axis L8. The members 708, 712, 716 are axially aligned along the longitudinal axis L8. The engagement member 712 is located between the driver member 708 and the base member 716. The driver member 708 and the engagement member 712 are rotatable relative to the housing 720 about the longitudinal axis L8. The base member 716 is rotationally fixed relative to the housing 720 about the longitudinal axis L8.

[0145] The driver member 708 includes a driver body 728. A proximal end face 730 of the driver body 728 includes a set of driver teeth 736. The driver teeth 736 are arranged about a longitudinal axis L8 with the roots of adjacent teeth 736 connected to one another at the proximal end face 730. Each driver tooth 736 has opposing tooth flanks 736a, 736b. In some embodiments, the tooth flanks 736a, 736b are inclined relative to the longitudinal axis L8. The tooth flanks 736a, 736b are inclined toward one another and meet at cusps having an acute angle α3. The inclination angles β1 and β2 of the tooth flanks 736a, 736b may be different.

[0146] The actuator driver 248 extends distally from the distal end of the driver body 728. The actuator driver 248 may be coupled to the driver body 728 using any suitable method, such as by inserting an end portion of the actuator driver 248 into a hole in the driver body 728 and securing the end portion to the hole.

[0147] The engagement member 712 includes an engagement body 740. A distal end surface of the engagement body 740 includes a set of engagement teeth 748 disposed about a longitudinal axis L8. As shown in FIG. 29B, the engagement teeth 748 have opposing tooth flanks 748a, 748b. In some embodiments, the tooth flanks 748a, 748b are inclined toward one another relative to the longitudinal axis L8. The tooth flanks 748a, 748b form tooth cusps 750 having an angle α4 that may be the same or different than the angle α3 between the driver tooth flanks 736a, 736b. The inclination angles β3 and β4 of the tooth flanks 748a, 748b may be the same or different from the inclination angles β1 and β2 of the driver tooth flanks 736a, 736b.

[0148] 29A , the output shaft 346 extends proximally from the proximal end of the engagement member 740. The output shaft 346 may be engaged to the engagement member body 740 using any suitable method (e.g., by inserting an end portion of the output shaft 346 into a bore in the engagement member body 740 and securing the end portion within the bore).

[0149] The engagement member 712 is axially aligned with the driver member 708 and oriented such that a set of engagement teeth 748 is in opposing relationship with a set of engagement teeth 732. The set of teeth 732, 744 are complementary in that the teeth 732, 744 can engage with one another in both the locked and unlocked states of the torque limiter. In some embodiments, the teeth 732, 744 can be complementary and have the same tooth profile. In other embodiments, the teeth 732, 744 can be complementary and have different tooth profiles. The two angled surfaces of each of the teeth 736, 748 allow the set of teeth 732, 744 to slide over one another during rotational movement of the actuator driver 248 in either direction.

[0150] The proximal end portion 710 of the engagement member 712 includes a set of locking teeth 756 disposed about the longitudinal axis L8. The locking teeth 756 of the set of locking teeth 756 are angularly spaced about the longitudinal axis L8 by slots 754. Each locking tooth 756 has opposing tooth flanks 756a, 756b oriented radially relative to the longitudinal axis L8. The opposing tooth flanks 756a, 756b are connected to a tooth tip 758. The edges between the tooth flanks 756a, 756b and the tooth crest 758 may be chamfered. The tooth flanks 756a, 756b on adjacent teeth 756 may be angled to form a wedge-shaped slot 754 (shown in FIG. 29C ) between the teeth.

[0151] The base member 716 includes a base body 760 having a distal end in opposing relationship to the proximal end of the engagement member 712. The distal end portion of the base body 760 includes a set of locking teeth 768 that are complementary to the set of locking teeth 756 in that the locking teeth 768 can engage (e.g., intermesh) with the locking teeth 756. The locking teeth 768 of the set of locking teeth 768 are spaced apart by slots 766. Each locking tooth 768 has opposing tooth flanks 768a, 768b that are oriented radially relative to the longitudinal axis L8. The opposing tooth flanks 768a, 768b are connected to a tooth tip 770. The edges between the tooth flanks 768a, 768b and the tooth crest 770 may be chamfered. Tooth surfaces 768a, 768b on adjacent teeth 768 may be angled to form a wedge-shaped slot 754 (FIG. 29C) between the teeth.

[0152] To form an interlock between the set of teeth 756, 768, the engagement member 712 may be displaced toward the base member 716 until the tooth tips 758, 770 are proximate one another. The engagement member 712 may be simultaneously rotated such that the locking tooth 756 of the engagement member 712 may slide into the slot 766 between the locking teeth 768 of the base member 716 when the locking tooth 756 of the engagement member 712 aligns with the slot 766 between the locking teeth 768 of the base member 716 (and the locking tooth 768 aligns with the slot 754 between the locking teeth 756). Further displacement of the engagement member 712 toward the base member 716 may force the locking tooth 756 further into the slot 766 until the tooth tip 758 contacts the bottom of the slot 766. In some embodiments, the slots 766, 754 may be wedge-shaped slots to form a secure interlock between the sets of teeth 756, 768 (wedge-shaped slot 754 is shown in FIG. 29C and wedge-shaped slot 766 may be similar to wedge-shaped slot 754).

[0153] The base member 716 may include a proximal flange 762 that may be attached to the housing 720 to rotationally secure the base member 716 relative to the housing 720 about the longitudinal axis L8. The output shaft 324 may extend proximally from the engagement member 712 through the proximal flange 762 and a central opening formed in the base body 760. A gear 344 of a gear train (e.g., the gear train 308 shown in FIGS. 10A-10C) is coupled to the output shaft 346. The output shaft 324 may be axially aligned with the longitudinal axis L8. A spring 724 may be disposed about the output shaft 324 between the engagement member 712 and the base member 716. In a free state, the spring 724 may exert a force on the engagement member 712 that biases the engagement member 712 toward the driver member 708.

[0154] FIG. 30A illustrates an initial state of the torque limiter 700 where the actuator torque is below a threshold value. In this initial state, the spring 724 is free, the engagement member 712 is biased against the driver member 708, and the driver teeth 732 and engagement teeth 748 are fully engaged. In this state, the locking teeth 756 of the engagement member 712 are separated (axially spaced) from the locking teeth 768 of the base member 716 by a gap G2, which may allow the engagement member 712 to be rotatable by the output shaft 346 (shown in FIG. 29A). Because the driver teeth 732 and engagement teeth 748 are engaged, rotation of the engagement member 712 may be transmitted to the actuator driver 248.

[0155] When the torque of the actuator driver 248 reaches a threshold value, the engagement member 712 begins to move in a proximal direction (i.e., toward the base member 716) as shown in FIG. 30B (where the gap G3 between the locking teeth 756, 768 is smaller than the previous G2 shown in FIG. 30A). The engagement teeth 748 begin to slide over the driver teeth 736 during the proximal movement of the engagement member 712, causing the engagement member 712 to act against the spring 724. While the engagement member 712 is displaced toward the base member 716 but the set of locking teeth 756 of the engagement member 712 is not engaged with the set of locking teeth 768 of the base member 716, rotation of the actuator driver 248 in either direction is possible by sliding the engagement teeth 748 over the driver teeth 736 in either direction.

[0156] As the torque of the actuator driver 248 increases, further movement of the engagement member 712 towards the base member 716 causes the locking teeth 756 of the engagement member 712 to interlock with the locking teeth 768 of the base member 716, as shown in Figures 30C and 30D. Once the locking teeth 756, 768 are interlocked, rotation of the engagement member 712 is no longer possible. As shown in Figure 30D, the distance between the driver member 708, engagement member 712, and base member 716 can be designed such that even when the locking teeth 756, 768 are interlocked, the engagement teeth 748 remain in contact with the driver teeth 732, thus effectively preventing rotational movement of the driver member 708 and the actuator driver 248.

[0157] The torque limiters 600 and 700 may be housed in the handle of the delivery device in the same manner as described for the torque limiter 400. For example, any of the torque limiters 600 and 700 may replace the torque limiter 400 shown in the handle 204 of FIG. 21A. One or more of the actuator drivers 248 coupled to the output shaft 324 of the gearbox 300 may have a corresponding torque limiter 600 or 700. In some embodiments, each of the actuator drivers 248 may have a corresponding torque limiter 600 or 700 such that the torque limiter 600 or 700 may act to stop the gearbox 300 if the torque of any one of the actuator drivers 248 exceeds a threshold value. By stopping the gearbox 300, damage to the natural anatomy and / or prosthetic heart valve may be prevented.

[0158] In some embodiments, while a user is rotating a knob (e.g., the first knob 264 shown in FIG. 8 ) coupled to the gear box 300 in a direction to expand the prosthetic heart valve, the torque of any one of the actuator drivers 248 may exceed a threshold. If the torque exceeds a threshold, a torque limiter (e.g., torque limiter 600 or 700) coupled to the actuator driver 248 may act to stop the gear box 300. When the gear box 300 is stopped, the user can no longer rotate the knob in a direction to expand the prosthetic heart valve. At this point, if the prosthetic heart valve is already expanded to a desired working diameter, the user can release the actuator driver 248 from the prosthetic heart valve. Alternatively, if the prosthetic heart valve is not at the desired working diameter, the user can compress the prosthetic heart valve by rotating the knob in a direction opposite to the expansion direction. The user can remove the prosthetic heart valve from the implantation site.

[0159] Any of the systems, devices, apparatus, etc. herein may be sterilized (e.g., using heat, radiation, and / or chemicals, etc.) to ensure that they are safe for use with patients, and any of the methods herein may 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.

[0160] The therapeutic 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 body simulations such as cadavers, cadaver hearts, simulators (e.g., simulating body parts, tissues, etc.).

[0161] [Example] Some examples based on the principles described herein are listed below. Examples 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 by combining one or more features of one embodiment with one or more features of one or more other embodiments.

[0162] Example 1. A delivery device for a prosthetic heart valve includes a handle having a proximal end, a distal end, and a cavity extending from the proximal end to the distal end, a first actuator driver having a proximal end portion disposed within the cavity and a distal end portion extending out of the cavity, a second actuator driver having a proximal end portion disposed within the cavity and a distal end portion extending out of the cavity, and a gear train disposed within the cavity and coupled to the proximal end portions of the first and second actuator drivers and configured to simultaneously rotate the first and second actuator drivers in opposite directions.

[0163] Example 2. The delivery device of Example 1, wherein the gear train comprises an input gear, a transmission gear engaged with and driven by the input gear, a first drive gear rotatably coupled to the transmission gear, a second drive gear engaged with and driven by the first drive gear, a first output gear engaged with and driven by the first drive gear, the first actuator driver coupled to the first output gear, and a second output gear engaged with and driven by the second drive gear, the second actuator driver coupled to the second output gear.

[0164] Example 3. The delivery device of example 2, wherein the handle further comprises a rotatable knob coupled to the input gear.

[0165] Example 4. The delivery device of example 3, wherein the rotatable knob is disposed on a proximal end of the handle.

[0166] Example 5. A delivery device described in any one of Examples 3-4, wherein the input gear is coupled to the input shaft and the rotatable knob is coupled to the input shaft.

[0167] Example 6. The delivery device of Example 5, wherein the transmission gear and the first drive gear are coupled to a first shaft arranged parallel to the input shaft, and the second drive gear is coupled to a second shaft arranged parallel to the first shaft.

[0168] Example 7. A delivery device described in any one of Examples 5 to 6, wherein the handle has a first longitudinal axis extending from the proximal end to the distal end, and the input shaft has a second longitudinal axis aligned with the first longitudinal axis.

[0169] Example 8. A delivery device for a prosthetic heart valve includes a handle having a longitudinal axis and a cavity extending along the longitudinal axis; a set of first actuator drivers, each first actuator driver having a proximal end portion disposed within the cavity and a distal end portion extending out of the cavity; a set of second actuator drivers, each second actuator driver having a proximal end portion disposed within the cavity and a distal end portion extending out of the cavity; a first drive gear coupled to the first actuator driver and configured to rotate the first actuator driver in a first direction; and a second drive gear coupled to the second actuator driver and configured to rotate the second actuator driver in a second direction opposite the first direction.

[0170] Example 9. The delivery device described in Example 8 further comprises an input shaft aligned with the longitudinal axis, an input gear coupled to the input shaft, a first shaft arranged parallel to the input shaft, and a transmission gear coupled to the first shaft and engaged with the input gear, wherein a first drive gear is coupled to the first shaft and a second drive gear is engaged with the first drive gear.

[0171] Example 10. The delivery device of Example 9 further comprises a second shaft disposed parallel to the first shaft, and a second drive gear is coupled to the second shaft.

[0172] Example 11. The delivery device described in any one of Examples 8 to 10 further includes a set of first output gears engaging with the first drive gear and a set of second output gears engaging with the second drive gear, each of the first output gears being coupled to a proximal end portion of one of the first actuator drivers, and each of the second output gears being coupled to a proximal end portion of one of the second actuator drivers.

[0173] Example 12. A delivery device described in any one of Examples 9 to 11, wherein the handle comprises a rotatable knob coupled to the input shaft.

[0174] Example 13. The delivery device described in any one of Examples 7 to 12 further comprises a shaft assembly coupled to the handle, the shaft assembly comprising a first delivery shaft having a first lumen and a second delivery shaft having a plurality of lumens, the second delivery shaft extending through the first lumen, and the first and second actuator drivers extending through the plurality of lumens of the second delivery shaft.

[0175] Example 14. A delivery device described in any one of Examples 7 to 13, wherein the set of first actuator drivers includes three first actuator drivers and the set of second actuator drivers includes three second actuator drivers.

[0176] Example 15. The prosthetic heart valve comprises a frame having an inflow end, an outflow end, and a longitudinal axis extending from the inflow end to the outflow end, the frame being movable between a radially expanded configuration and a radially compressed configuration, a first actuator coupled to the frame at a first location, and a second actuator coupled to the frame at a second location spaced from the first location along a circumference of the frame, wherein the frame moves between the radially expanded configuration and the radially compressed configuration when the first actuator rotates in a first rotational direction and the second actuator rotates in a second rotational direction opposite the first rotational direction.

[0177] Example 16. 16. The prosthetic heart valve of Example 15, wherein the first actuator comprises a threaded portion having a first configuration and the second actuator comprises a threaded portion having a second configuration opposite the first configuration.

[0178] Example 17. An artificial heart valve as described in any one of Examples 15 to 16, wherein the frame comprises a plurality of support posts aligned on a longitudinal axis and a plurality of struts interconnecting the support posts, a first actuator being coupled to a first support post of the plurality of support posts, and a second actuator being coupled to a second support post of the plurality of support posts.

[0179] Example 18. 18. The prosthetic heart valve of Example 17, wherein each of the first support post and the second support post comprises a gap, and each of the actuators comprises an actuator rod extending across the gap of the respective support post, and rotation of each of the actuation rods adjusts the size of the gap of the respective support post.

[0180] Example 19. The prosthetic heart valve according to any one of Examples 15 to 18 further comprises a valve structure disposed within and coupled to the frame.

[0181] Example 20. The delivery assembly comprises a prosthetic heart valve comprising a frame having an inflow end, an outflow end, and a longitudinal axis extending from the inflow end to the outflow end and movable between a radially expanded configuration and a radially compressed configuration, a first actuator coupled to the frame at a first location, and a second actuator coupled to the frame at a second location spaced from the first location along a circumference of the frame. The delivery assembly further comprises a handle having a proximal end, a distal end, and a cavity extending from the proximal end to the distal end, a first actuator driver having a proximal end portion disposed within the cavity and a distal end portion extending out of the cavity and removably coupled to the first actuator, a second actuator driver having a proximal end portion disposed within the cavity and a distal end portion extending out of the cavity and removably coupled to the second actuator, and a gear train disposed within the cavity and coupled to the proximal end portions of the first and second actuator drivers and configured to simultaneously rotate the first and second actuator drivers in opposite directions.

[0182] Example 21. The delivery assembly of Example 20, wherein the prosthetic heart valve further comprises a valve structure disposed within and coupled to the frame.

[0183] Example 22. A delivery device for a prosthetic heart valve comprises a handle having a cavity, a gear box disposed within the cavity and having at least one output shaft and a gear coupled thereto, an actuator driver having a predetermined torque limit range, and a rotatable assembly coupling the at least one output shaft to the actuator driver, the rotatable assembly having a first rotational state in which the at least one output shaft and the actuator driver rotate together about a longitudinal axis, and a second rotational state in which the at least one output shaft and the actuator driver do not rotate together about the longitudinal axis, the first rotational state corresponding to when a torque applied to the actuator driver is below the predetermined torque limit range, and the second rotational state corresponding to when a torque applied to the actuator driver is within the predetermined torque limit range.

[0184] Example 23. The delivery device of Example 22, wherein the rotatable assembly comprises a first rotatable body coupled to at least one output shaft, a second rotatable body coupled to an actuator driver, and a rotational biasing member coupling the first rotatable body to the second rotatable body.

[0185] Example 24. 24. The delivery device of example embodiment 23, wherein the rotational biasing member comprises a torsion spring having a coil portion, a first end portion coupled to the first rotatable body, and a second end portion coupled to the second rotatable body.

[0186] Example 25. 25. The delivery device of example 24, wherein the torsion spring is configured to twist in a direction that reduces the angular spacing between the first end portion and the second end portion when a torque applied to the actuator driver is within a predetermined torque limit range.

[0187] Example 26. The delivery device of Example 24, wherein the torsion spring has a preload, and the rotatable assembly transitions from the first rotated state to the second rotated state when a torque applied to the actuator driver exceeds the preload in the torsion spring.

[0188] Example 27. 27. A delivery device described in any one of Examples 24 to 26, further comprising a connector shaft extending through the second rotatable body, the coil portion being disposed around the connector shaft.

[0189] Example 28. 28. The delivery device of Example 27, wherein a first end portion of the connector shaft extends into the first rotatable body and a second end portion of the connector shaft is coupled to the actuator driver.

[0190] Example 29. A delivery device described in any one of Examples 23 to 28, wherein the rotatable assembly further comprises a tapered channel and a wedge member movably disposed within the tapered channel, the wedge member preventing rotational movement of the first and second rotatable bodies when the wedge member is positioned at a predetermined position within the tapered channel.

[0191] Example 30. 30. The delivery device of Example 29, wherein the wedge member has a first end portion coupled to the first rotatable body and a second end portion disposed within the tapered channel.

[0192] Example 31. A delivery device described in any one of Examples 29-30, wherein the tapered channel is formed on the periphery of the second rotatable body.

[0193] Example 32. The delivery device of Example 31, wherein the rotatable assembly further comprises a housing, a tapered channel being formed between an inner surface of the housing and an outer surface of the second rotatable body, and the wedge member is interference-engaged with both the inner and outer surfaces at a predetermined position.

[0194] Example 33. 33. The delivery device of Example 32, wherein an outer surface of the second rotatable body comprises a recessed portion, and a tapered channel is formed between the recessed portion and an inner surface of the housing.

[0195] Example 34. The delivery device of Example 33, wherein the outer surface of the second rotatable body has a first radial shoulder and a second radial shoulder spaced circumferentially around the second rotatable body, and the concave portion is formed between the first radial shoulder and the second radial shoulder.

[0196] Example 35. A delivery device described in any one of Examples 32 to 34, wherein the housing is a compartment of a gearbox housing.

[0197] Example 36. A delivery device as described in Example 25, wherein the second rotatable body has a pair of tapered concave portions at diametrically opposed positions, the pair of tapered concave portions defining a pair of tapered channels.

[0198] Example 37. The delivery device of Example 36, further comprising a pair of wedge members, each of which has a first end portion coupled to the first rotatable body and a second end portion disposed within one of the tapered channels, each of which is movable along its respective tapered channel in response to relative movement between the first and second rotatable bodies during torsion of the torsion spring, and wherein the second end portion of each wedge member is configured to form a wedge at a predetermined position within its respective tapered channel that prevents further rotation of the first and second rotatable bodies.

[0199] Example 38. A delivery device described in any one of Examples 36-37, wherein each of the tapered channels tapers in a direction along the circumference of the second rotatable body.

[0200] Example 39. A delivery device described in any one of Examples 24 to 38, wherein the first rotatable body has a first recess that receives a first portion of the coil portion of the torsion spring and a first slot that receives a first end portion of the torsion spring, and the second rotatable body has a second recess that receives a second end portion of the coil portion and a second slot that receives the second end portion.

[0201] Example 40. 40. The delivery device of example embodiment 39, wherein the actuator driver extends through the coil portion and the first and second recesses.

[0202] Example 41. A delivery device for a prosthetic heart valve comprises a handle having a cavity, a gearbox disposed within the cavity and comprising a plurality of output shafts and a plurality of output gears coupled thereto, a plurality of actuator drivers, each actuator driver having a predetermined torque limit range, and a plurality of rotatable assemblies, each of the rotatable assemblies coupled at a first end to one of the output shafts and at a second end to one of the actuator drivers, each rotatable assembly comprising a first rotatable body, a second rotatable body, and a rotational biasing member coupling the first rotatable body to the second rotatable body, the rotational biasing member biasing the first rotatable body and the second rotatable body to a position where the first rotatable body and the second rotatable body rotate together about the longitudinal axis when a torque applied to the actuator driver is below the predetermined torque limit range, and the rotational biasing member permits relative rotation between the first rotatable body and the second rotatable body about the longitudinal axis when a torque applied to the actuator driver is within the predetermined torque limit range.

[0203] Example 42. A delivery device for a prosthetic heart valve includes a handle body having a longitudinal axis and a gearbox pivotally mounted within the handle body about the longitudinal axis.

[0204] Example 43. The delivery device of Example 42, wherein the gearbox comprises a gearbox housing and a gear train disposed within the gearbox housing, and further comprises a rotatable knob coupled to the gear train.

[0205] Example 44. A delivery device for a prosthetic heart valve includes a handle body having a longitudinal axis, a gearbox pivotally mounted within the handle body about the longitudinal axis, and a stop member coupled to the handle body and positioned to limit rotation of the gearbox about the longitudinal axis when the gearbox is pivoted in a predetermined direction.

[0206] Example 45. The delivery device of Example 44, wherein the gearbox comprises a gear train having an input shaft aligned with the longitudinal axis, and a gearbox housing enclosing the gear train, the gearbox housing having an extension arm protruding from an outer surface of the gearbox housing and a protruding member attached to the extension arm, the protruding member being configured to contact a stop member when the gearbox rotates in a predetermined direction.

[0207] Example 46. The delivery device of Example 45, wherein the protruding members are oriented in a direction perpendicular to the longitudinal axis.

[0208] Example 47. A delivery device described in any one of Examples 44 to 46, wherein the predetermined direction is a direction in which the prosthetic heart valve is expanded.

[0209] Example 48. A delivery device described in any one of Examples 44 to 47, wherein the stop member comprises a load cell, and the protruding member is configured to apply a load to the load cell when the gear box is pivoted in a predetermined direction.

[0210] Example 49. A delivery device for a prosthetic heart valve comprises a handle body having a longitudinal axis, a load cell coupled to the handle body and having a first axial axis positioned tangentially to a circular path centered on the longitudinal axis, and a gearbox having a protruding member pivotally mounted about the longitudinal axis and having a first axial axis positioned tangentially to the circular path, the protruding member configured to contact the load cell when the gearbox is pivoted in a predetermined direction corresponding to movement of the gearbox to expand the prosthetic heart valve.

[0211] Example 50. The delivery device of Example 49, wherein the gearbox comprises a gearbox housing and a gear train disposed within the gearbox housing, and further comprises a rotatable knob coupled to the gear train.

[0212] Example 51. A delivery device for a prosthetic heart valve comprises an actuator driver, a gearbox having at least one output shaft, an engagement member coupled to the at least one output shaft and rotatable about a longitudinal axis with the at least one output shaft and having a first engagement surface and a first locking surface spaced along the longitudinal axis, a driver member coupled to the actuator driver and rotatable about the longitudinal axis and having a second engagement surface in opposing relationship with the first engagement surface and engaging the first engagement surface, and a base member rotationally fixed relative to the longitudinal axis and having a second locking surface in opposing relationship with the first locking surface, wherein the engagement member is axially displaceable along the longitudinal axis in response to torque of the actuator driver between a first position in which the first locking surface is disengaged from the second locking surface and a second position in which the first locking surface is engaged with the second locking surface, the second position corresponding to a condition in which the torque of the actuator driver exceeds a threshold value.

[0213] Example 52. The delivery device described in any embodiment herein, particularly embodiment 51, wherein at least one output shaft extends through a central opening of the base member.

[0214] Example 53. A delivery device described in any of the embodiments herein, particularly any one of embodiments 51-52, further comprising a spring arranged to apply a force to the engagement member biasing the first engagement surface against the second engagement surface in the first position.

[0215] Example 54. The delivery device described in any embodiment herein, particularly embodiment 53, wherein the spring is disposed around the at least one output shaft between the engagement member and the base member.

[0216] Example 55. A delivery device described in any one of the embodiments herein, particularly any one of embodiments 51-54, wherein the first locking surface comprises a first set of locking teeth and the second locking surface comprises a second set of locking teeth complementary to the first set of locking teeth.

[0217] Example 56. A delivery device as described in any of the embodiments herein, particularly embodiment 55, wherein the first set of locking teeth comprises a plurality of first teeth separated by a first slot, the second set of locking teeth comprises a plurality of second teeth separated by a second slot, the plurality of first teeth configured to extend into the second slot, and the plurality of second teeth configured to extend into the first slot to interlock the first set of locking teeth with the second set of locking teeth.

[0218] Example 57. A delivery device described in any one of the embodiments herein, particularly any one of embodiments 51-56, wherein the first engagement surface comprises a set of engagement teeth and the second engagement surface comprises a set of driver teeth complementary to the set of engagement teeth.

[0219] Example 58. A delivery device as described in any of the embodiments herein, particularly embodiment 57, wherein each tooth of the set of engaging teeth has a first axial tooth surface and a first inclined tooth surface joined at a first tooth cusp, each tooth of the set of driver teeth has a second axial tooth surface and a second inclined tooth surface joined at a second tooth cusp, and the first inclined tooth surface of the set of engaging teeth slides along the second inclined tooth surface of the set of engaging teeth during axial displacement of the engagement member.

[0220] Example 59. A delivery device as described in any of the embodiments herein, particularly embodiment 57, wherein each tooth of the set of engagement teeth has a first inclined tooth surface and a second inclined tooth surface joined at a first tooth cusp, and each tooth of the set of driver teeth has a third inclined tooth surface and a fourth inclined tooth surface joined at a second tooth cusp end, and the first and second inclined tooth surfaces slide over the third and fourth inclined tooth surfaces in a first rotational direction about the longitudinal axis or in a second rotational direction about the longitudinal axis during axial displacement of the engagement member.

[0221] Example 60. The delivery device of any of the embodiments herein, particularly any one of embodiments 51-59, further comprising a housing, wherein the engagement member, the driver member, and the base member are disposed inside the housing.

[0222] Example 61. The delivery device of any embodiment herein, particularly embodiment 60, wherein the engagement member and the driver member are rotatable relative to the housing, and the base member is fixedly coupled to the housing.

[0223] Example 62. A delivery device described in any one of the embodiments herein, particularly any one of embodiments 60-61, wherein the housing is coupled to a gear box.

[0224] Example 63. A delivery device described in any of the embodiments herein, particularly any one of embodiments 51 to 62, further comprising a handle, wherein the gearbox is disposed in a cavity within the handle.

[0225] Example 64. A delivery device for a prosthetic heart valve includes a handle having a cavity, a gearbox disposed within the cavity and having at least one output shaft, an actuator driver extending into the cavity, a torque limiter coupling the actuator driver to the at least one output shaft, an engagement member coupled to the at least one output shaft and rotatable about a longitudinal axis in response to rotation of the at least one output shaft, the engagement member having a set of engagement teeth at a first end and a first set of locking teeth at a second end spaced from the first end, and an actuator rotatable about a longitudinal axis and configured to engage the actuator. a torque limiter comprising: a driver member coupled to the actuator driver, the driver member having a set of driver teeth in opposing relationship with and slidably engaging the set of engagement teeth; and a base member rotationally fixed relative to the longitudinal axis and having a second set of locking teeth in opposing relationship with the first set of locking teeth, wherein the engagement member is axially displaceable along the longitudinal axis in response to a torque of the actuator driver, the engagement member being axially displaceable to engage the first set of locking teeth with the second set of locking teeth when the torque of the actuator driver exceeds a threshold value.

[0226] Example 65. A delivery device as described in any of the embodiments herein, particularly embodiment 64, wherein the gearbox has a plurality of output shafts and a plurality of torque limiters couple the plurality of output shafts to a corresponding plurality of actuator drivers.

[0227] Example 66. A delivery device for a prosthetic heart valve comprises an actuator driver, a gearbox having at least one output shaft, a base member rotationally fixed relative to a longitudinal axis, and an engagement member movably coupled to the actuator driver and fixedly coupled to the at least one output shaft, the engagement member being axially displaceable relative to the actuator driver and base member along the longitudinal axis in response to torque of the actuator driver, the engagement member being configured to engage the base member when the torque of the actuator driver exceeds a threshold value.

[0228] Example 67. The method includes coupling the prosthetic heart valve to at least one actuator driver of a delivery device, where an engagement member is movably coupled to the at least one actuator driver and fixedly coupled to an output shaft of a gearbox of the delivery device, where the engagement member is axially displaceable along a longitudinal axis between the at least one actuator driver and a base member that is rotationally fixed relative to the longitudinal axis in response to a torque of the at least one actuator driver, and rotating the output shaft of the gearbox to rotate the at least one actuator driver in a first direction to radially expand the prosthetic heart valve to an operating diameter, where rotation of the output shaft is automatically stopped by engagement of the engagement member with the base member if a torque of the at least one actuator driver exceeds a threshold value.

[0229] Example 68. The method of any of the examples herein, particularly Example 67, may further include inserting the prosthetic heart valve and a distal end of a delivery device into the patient's vascular system, and advancing the delivery device through the patient's vascular system to position the prosthetic heart valve at the implantation site.

[0230] Example 69. The method of any embodiment herein, particularly any one of embodiments 67-68, may further include rotating the output shaft in a second direction to radially compress the prosthetic heart valve.

[0231] Example 70. The method of any embodiment herein, particularly any one of embodiments 67-69, may further include releasing the prosthetic heart valve from the at least one actuator driver.

[0232] Example 71. The method of any of the embodiments herein, particularly any one of embodiments 67-70, wherein rotating the output shaft comprises rotating a knob coupled to the gearbox.

[0233] Example 72. A method comprising sterilizing any one of the delivery devices described in any one of Examples 1-14 and 20-66.

[0234] Example 73. A method comprising sterilizing any one of the prosthetic heart valves according to any one of Examples 15 to 19.

[0235] Example 74. 67. A method comprising implanting a prosthetic device using any one of the delivery devices of claims 1-14 and 20-66.

[0236] Example 75. A method of simulating an implantation procedure for a prosthetic device using any one of the delivery devices described in any one of Examples 1-14 and 20-66.

[0237] Example 76. A delivery device for a prosthetic heart valve comprises a driver member rotatable about a first axis, an output shaft rotatable about the first axis, and an engagement member rotatably coupled to the output shaft and configured to move between an unlocked state and a locked state, wherein the driver member is configured to generate a torque on the engagement member when rotated about the first axis, the torque of the engagement member configured to cause the engagement member to move from the unlocked state to the locked state when the torque of the engagement member exceeds a predetermined threshold amount, and the engagement member prevents the output shaft from rotating about the first axis when in the locked state.

[0238] Although the subject matter of the invention is described with certain 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 following claims and equivalents thereof.

Claims

1. 1. A delivery device for a prosthetic heart valve, comprising: a handle having a longitudinal axis and a cavity extending along the longitudinal axis; a set of actuator drivers comprising a first actuator driver and a second actuator driver, each of the first actuator driver and the second actuator driver having a proximal end portion disposed within the cavity and a distal end portion extending out of the cavity; a gear train coupled to the proximal end portions of the first actuator driver and the second actuator driver and configured to simultaneously rotate the first actuator driver and the second actuator driver in opposite directions.

2. the gear train includes an input gear; an input shaft disposed within the cavity and coupled to the input gear; The delivery device of claim 1 , further comprising: a rotatable knob disposed at a proximal end of the handle and coupled to the input shaft.

3. The gear train includes: a transmission gear engaged with and driven by the input gear; a first drive gear rotatably coupled to the transmission gear; a second drive gear engaged with and driven by the first drive gear; a first output gear engaged with and driven by the first drive gear, the first actuator driver being coupled to the first output gear; 3. The delivery device of claim 2, further comprising: a second output gear engaged with and driven by the second drive gear, the second actuator driver coupled to the second output gear.

4. 10. The delivery device of claim 1, wherein the first actuator driver is one of a plurality of first actuator drivers and the second actuator driver is one of a plurality of second actuator drivers, and the gear train is configured to simultaneously rotate the plurality of first actuator drivers in a first direction and the plurality of second actuator drivers in a second direction opposite the first direction.

5. 5. The delivery device of claim 4, wherein the gear train comprises: a first drive gear coupled to the plurality of first actuator drivers and configured to rotate the plurality of first actuator drivers in the first direction; and a second drive gear coupled to the plurality of second actuator drivers and configured to rotate the plurality of second actuator drivers in the second direction.

6. The gear train includes: a plurality of first output gears engaged with the first drive gear; a plurality of second output gears engaged with the second drive gears; each of the first output gears is coupled to the proximal end portion of one of the first actuator drivers; The delivery device of claim 5 , wherein each of the second output gears is coupled to the proximal end portion of one of the second actuator drivers.

7. 2. The delivery device of claim 1, further comprising a shaft assembly coupled to the handle, the shaft assembly comprising a first delivery shaft having a first lumen and a second delivery shaft having multiple lumens, the second delivery shaft extending through the first lumen, and the first and second actuator drivers extending through the multiple lumens of the second delivery shaft.

8. 8. The delivery device of claim 1, further comprising a gearbox mounted within the cavity and pivotable about the longitudinal axis, the gearbox housing one or more components of the gear train.

9. 9. The delivery device of claim 8, further comprising a stop member coupled to the handle and positioned to limit rotation of the gearbox about the longitudinal axis when the gearbox is pivoted in a predetermined direction.

10. 10. The delivery device of claim 9, wherein the stop member comprises a load cell, and the gearbox comprises a protruding member configured to apply a load to the load cell when the gearbox is pivoted in the predetermined direction.

11. 1. A delivery device for a prosthetic heart valve, comprising: a driver member rotatable about a first axis; an output shaft rotatable about the first axis; an engagement member rotatably coupled to the output shaft and configured to move between an unlocked state and a locked state; the driver member is configured to generate a torque on the engagement member when rotated about the first axis, the torque on the engagement member configured to move the engagement member from the unlocked state to the locked state when the torque on the engagement member exceeds a predetermined threshold amount, and the engagement member, when in the locked state, prevents the output shaft from rotating about the first axis.

12. 12. The delivery device of claim 11, wherein the engagement member is axially displaceable relative to the driver member in response to the torque along the first axis, the engagement member comprising a set of engagement teeth at a first end, and the driver member comprising a set of driver teeth in opposing relationship with the set of engagement teeth.

13. The delivery device of claim 12 , further comprising a biasing member disposed to apply a biasing force to the engagement member that biases the set of engagement teeth against the set of driver teeth in the unlocked state.

14. each tooth of the set of engaging teeth includes a first axial tooth flank and a first inclined tooth flank joined at a first cusp; each tooth of the set of driver teeth includes a second axial tooth flank and a second inclined tooth flank joined by a second cusp; 14. The delivery device of claim 13, wherein the first inclined tooth surface of the set of engagement teeth slides along the second inclined tooth surface of the set of engagement teeth during axial displacement of the engagement member.

15. each tooth of the set of engaging teeth includes a first inclined tooth surface and a second inclined tooth surface joined at a first cusp; each tooth of the set of driver teeth includes a third inclined tooth surface and a fourth inclined tooth surface joined at a second cusp; 14. The delivery device of claim 13, wherein the first and second inclined tooth surfaces slide over the third and fourth inclined tooth surfaces in a first rotational direction about the first axis or a second rotational direction about the first axis during axial displacement of the engagement member along the first axis.

16. 14. The delivery device of claim 13, further comprising a base member rotationally fixed relative to the first axis, the engagement member being axially displaceable along the first axis to engage the base member when the torque of the engagement member exceeds the predetermined threshold amount.

17. the engaging member includes a first set of locking teeth at a second end spaced from the first end; 17. The delivery device of claim 16, wherein the base member comprises a second set of locking teeth in opposing relationship to the first set of locking teeth, the second set of locking teeth configured to engage the first set of locking teeth in the locked state.

18. 18. The delivery device of claim 16, wherein the output shaft extends through a central opening in the base member, and the biasing member comprises a spring disposed around the output shaft and between the engagement member and the base member.

19. 1. A method comprising: coupling the prosthetic heart valve to a driver member configured to generate torque on an engagement member, the engagement member being coupled to an output shaft of a gearbox and having a locked state and an unlocked state; rotating the output shaft in a first direction to radially expand the prosthetic heart valve to a working diameter; transmitting rotation of the output shaft to the driver member by engagement of the engagement member with the driver member in the unlocked state of the engagement member; and moving the engagement member from the unlocked state to the locked state when the torque on the engagement member exceeds a predetermined threshold amount.

20. 20. The method of claim 19, wherein rotating the output shaft comprises rotating a knob coupled to the gearbox.

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