WO2023183249A1

WO2023183249A1 - Delivery apparatus and methods for implanting prosthetic heart valves

Info

Publication number: WO2023183249A1
Application number: PCT/US2023/015669
Authority: WO
Inventors: Elazar Levi SCHWARCZ; Natanel Simcha SIROTE; Peleg HAREL
Original assignee: Edwards Lifesciences Corporation
Priority date: 2022-03-22
Filing date: 2023-03-20
Publication date: 2023-09-28

Abstract

A method of implanting a prosthetic heart valve includes engaging an actuator driver coupled to a shaft with an actuator coupled to a frame of the prosthetic heart valve. The prosthetic heart valve is delivered to an implantation location. A diameter of the prosthetic heart valve is adjusted by rotating a knob coupled to the shaft. The knob is released to stop adjustment of the diameter of the prosthetic heart valve. After releasing the knob, the knob or a locker disposed between knob and the shaft is tilted relative to the shaft to prevent backlash of the knob.

Description

DELIVERY APPARATUS AND METHODS

FOR IMPLANTING PROSTHETIC HEART VALVES

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Application No. 63/423,887, filed November 9, 2022, and U.S. Provisional Application No. 63/322,294, filed March 22, 2022, both of which are incorporated by reference herein.

FIELD

[0002] The field relates to implantable prosthetic devices, such as prosthetic heart valves, and to delivery apparatus and methods for implanting prosthetic heart valves.

BACKGROUND

[0003] The human heart can suffer from various valvular diseases. These valvular diseases can result in significant malfunctioning of the heart and ultimately require repair of the native valve or replacement of the native valve with an artificial valve. There are a number of known repair devices (e.g., stents) and artificial valves, as well as a number of known methods of implanting these devices and valves in humans. Percutaneous and minimally - invasive surgical approaches are used in various procedures to deliver prosthetic medical devices to locations inside the body that are not readily accessible by surgery or where access without surgery is desirable.

[0004] In one specific example, a prosthetic heart valve can be mounted in a crimped state on the distal end of a delivery apparatus and advanced through the patient’s vasculature (e.g., through a femoral artery and the aorta) until the prosthetic heart valve reaches the implantation site in the heart. The prosthetic heart valve is then expanded to its functional size, for example, by inflating a balloon on which the prosthetic valve is mounted, actuating a mechanical actuator that applies an expansion force to the prosthetic heart valve, or by deploying the prosthetic heart valve from a sheath of the delivery apparatus so that the prosthetic heart valve can self-expand to its functional size.

[0005] Prosthetic heart valves that rely on a mechanical actuator for expansion can be referred to as “mechanically expandable” prosthetic heart valves. Mechanically expandable prosthetic heart valves can provide one or more advantages over self-expandable and balloonexpandable prosthetic heart valves. For example, mechanically expandable prosthetic heart valves can be expanded to various diameters. Mechanically expandable prosthetic heart valves can also be compressed after an initial expansion (e.g., for repositioning and/or retrieval). However, some known devices and methods can cause rotation or movement of the prosthetic valve during expansion.

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

SUMMARY

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

[0008] A delivery apparatus for a prosthetic heart valve can comprise a handle and one or more shafts coupled to the handle.

[0009] In some examples, a delivery apparatus for a prosthetic heart valve comprises a handle body, a shaft, a knob, and a pin. The shaft is disposed within a cavity of the handle body and has a first longitudinal axis. The knob is rotatably coupled to the handle body and has a second longitudinal axis. The pin couples the shaft to the knob and is eccentric relative to the first longitudinal axis and the second longitudinal axis. A first movement of the pin due to rotation of the knob about the second longitudinal axis rotates the shaft about the first longitudinal axis. A second movement of the pin due to release of the knob tilts the knob relative to the shaft and about the pin.

[0010] In some examples, a handle for the delivery apparatus comprises a shaft, a knob, and a pin. The shaft is rotatably disposed about a first longitudinal axis. The knob is rotatably disposed about a second longitudinal axis. The pin is eccentric to the first longitudinal axis and the second longitudinal axis. The shaft is fixedly coupled to a first end portion of the pin and the knob is pivotable on a second end portion of the pin such that a first movement of the pin due to the rotation of the knob rotates the shaft and a second movement of the pin due to release of the knob tilts the knob relative to the shaft and about the second end portion of the pin.

[0011] In some examples, a method of implanting a prosthetic heart valve comprises engaging an actuator driver coupled to a shaft with an actuator coupled to a frame of the prosthetic heart valve and delivering the prosthetic heart valve to an implantation location. The method can further include adjusting a diameter of the prosthetic heart valve by rotating a knob coupled to the shaft. The method can further include releasing the knob from rotation, wherein releasing the knob from rotation tilts the knob relative to the shaft to prevent backlash of the knob.

[0012] In some examples, a delivery apparatus for a prosthetic heart valve comprises a handle body, a shaft, a knob, a locker, and a first pin. The shaft is disposed within a cavity of the handle body and has a first longitudinal axis. The knob is rotatably coupled to the handle body. The knob has a second longitudinal axis. The locker comprises a first locker member having a third longitudinal axis. The first locker member is pivotally coupled to the knob. The first pin couples the shaft to the first locker member and is eccentric relative to the first longitudinal axis and the third longitudinal axis. A first movement of the first pin due to rotation of the knob rotates the shaft about the first longitudinal axis. A second movement of the first pin due to release of the knob tilts the first locker member relative to the shaft and about the first pin.

[0013] hi some examples, a handle for a delivery apparatus comprises a shaft, a knob, a locker member, and a first pin. The shaft is rotatably disposed about a first longitudinal axis. The knob is rotatably disposed about a second longitudinal axis. The locker member has a third longitudinal axis and is pivotably coupled to the knob. The first pin couples the shaft to the locker member and is eccentric relative to the first longitudinal axis and the third longitudinal axis. A first movement of the first pin due to rotation of the knob rotates the shaft. A a second movement of the first pin due to release of the knob from rotation tilts the locker member relative to the shaft and the knob and about the first pin.

[0014] In some examples, a method of implanting a prosthetic heart valve comprises engaging an actuator driver coupled to a shaft of a handle with an actuator coupled to a frame of the prosthetic heart valve and delivering the prosthetic heart valve to an implantation location. The method can further include adjusting a diameter of the prosthetic heart valve by rotating a knob coupled to the shaft by a locker member. The method can further include releasing the knob to stop adjustment of the diameter of the prosthetic heart valve, wherein releasing the knob tilts the locker member relative to the shaft and the knob to prevent backlash of the knob.

[0015] In some examples, a delivery apparatus for a prosthetic heart valve comprises a handle body, a gear train disposed within the handle body, a knob rotatably coupled to the handle body, and a flexible coupling disposed between the gear train and the knob and operatively coupling the knob to the gear train.

[0016] In some examples, a delivery assembly comprises a prosthetic heart valve releasably coupled to any of the handles or any of the delivery apparatus.

[0017] In some examples, a delivery apparatus for a prosthetic heart valve, the delivery apparatus comprises a handle body having a cavity, a shaft disposed within the cavity, a knob having a longitudinal axis and rotatable relative to the handle body about the longitudinal axis, a first rotatable knob member fixedly coupled to the knob, a second rotatable knob member fixedly coupled to the shaft and rotatably coupled to the first rotatable knob member; and a first biased movable member disposed between the first rotatable knob member and the second rotatable knob member, the first biased movable member forming a first releasable rotational lock between the first rotatable knob member and the second rotatable knob member in a free state, wherein the first releasable rotational lock prevents spontaneous rotation of the knob in at least one of a first rotational direction and a second rotational direction that is opposite to the first rotational direction.

[0018] In some examples, a method of implanting a prosthetic heart valve, comprising engaging an actuator driver with an actuator of a prosthetic heart valve, wherein the actuator driver is coupled to a shaft, rotating a knob in a first direction to release a biased movable member from forming a rotational lock between a first rotatable knob member coupled to the knob and a second rotatable knob member coupled to the shaft; after releasing the biased movable member form forming the rotational lock, further rotating the knob in the first direction to transfer torque to the shaft through the first rotatable knob member and the second rotatable knob member, wherein the torque transferred to the shaft causes the actuator driver to rotate the actuator and adjust a diameter of the prosthetic heart valve; and releasing the knob to stop adjustment of the diameter of the prosthetic heart valve, wherein releasing the knob returns the biased movable member to forming the rotational lock between the first rotatable knob member and the second rotational knob member.

[0019] In some examples, a delivery apparatus for a prosthetic heart valve, the delivery apparatus comprising a handle body having a cavity, a shaft disposed within the cavity, a knob rotatable relative to the handle body about a longitudinal axis, a first rotatable knob member coupled to the knob and rotatable with the knob, a second rotatable knob member coupled to the shaft and rotatable with the shaft, a first rotational biasing member coupling the second rotatable knob member to the first rotatable knob member at a first position, the first rotational biasing member forming a first releasable rotational lock between the first rotatable knob member and the second rotatable knob member in a free state, wherein the first releasable rotational lock prevents spontaneous rotation of the knob in a first rotational direction.

[0020] In some examples, a method of implanting a prosthetic heart valve, comprising engaging an actuator driver with an actuator of a prosthetic heart valve, wherein the actuator driver is coupled to a shaft, rotating a knob in a first direction to release a first rotational biasing member from forming a first rotational lock between a first rotatable knob member coupled to the knob and a second rotatable knob member coupled to the shaft that resists rotation of the knob in the first direction, after releasing the first rotational biasing member from forming the first rotational lock, further rotating the knob in the first direction to transfer torque to the shaft through the first rotatable knob member and the second rotatable knob member, wherein the torque transferred to the shaft causes the actuator driver to rotate the actuator and adjust a diameter of the prosthetic heart valve, and releasing the knob to stop adjustment of the diameter of the prosthetic heart valve, wherein releasing the knob returns the first rotational biasing member to forming the first rotational lock between the first rotatable knob member and the second rotatable knob member.

[0021] The various innovations of this disclosure can be used in combination or separately. This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the detailed description. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. The foregoing and other objects, features, and advantages of the disclosure will become more apparent from the following detailed description, claims, and accompanying figures.

BRIEF DESCRIPTION OF THE DRAWINGS

[0022] FIG. 1 is a perspective view of a prosthetic heart valve.

[0023] FIG. 2A is a perspective view of the prosthetic heart valve in a radially expanded configuration with the valvular structure removed, depicting actuator heads at an outflow end of the frame.

[0024] FIG. 2B is a perspective view of the prosthetic heart valve in a radially expanded configuration, depicting actuator heads at an inflow end of the frame.

[0025] FIG. 3 is a detail view of an actuator of the prosthetic heart valve.

[0026] FIG. 4A is a side view of a proximal end portion of a delivery apparatus.

[0027] FIG. 4B is a side view of a distal end portion of a deliver)' apparatus with the prosthetic heart valve in a radially expanded configuration coupled thereto.

[0028] FIG. 5 is a cross-sectional view of a shaft assembly of the delivery apparatus, taken along line 5-5 of FIG. 4B.

[0029] FIG. 6 is a perspective view of a portion of an actuation assembly of the delivery apparatus.

[0030] FIG. 7A is a perspective view of the actuation assembly of the delivery apparatus aligned with an actuator of the prosthetic heart valve.

[0031] FIG. 7B is a perspective view of the actuation assembly engaged with the actuator.

[0032] FIG. 7C is a perspective view of the outer sleeve of the actuation assembly engaged with the frame of the prosthetic heart valve.

[0033] FIG. 8 is a cross-section of a handle of the delivery apparatus, taken along line 8-8 of FIG. 4A.

[0034] FIG. 9A is a portion of the handle of the delivery apparatus depicting a gearbox within the handle coupled to a knob of the handle. [0035] FIG. 9B is a perspective view of the gearbox with the gearbox housing depicted as transparent.

[0036] FIG. 9C is a perspective view of a portion of the handle of the delivery apparatus depicting compartments inside the gearbox housing.

[0037] FIG. 10A is a perspective view of a gear train of the gearbox.

[0038] FIG. 10B is a plan view of the gear train in a direction parallel to the longitudinal axis of the handle.

[0039] FIG. 10C is a plan view of the gear train in a direction transverse to the longitudinal axis of the handle.

[0040] FIG. 11 is another perspective view of the prosthetic heart valve without the valvular structure and illustrating division of the actuation rods into two sets.

[0041] FIG. 12 is a schematic of a delivery assembly including the prosthetic heart valve in a radially expanded configuration and the delivery apparatus,

[0042] FIG. 13A is a perspective view of a torque limiter for an actuator driver.

[0043] FIG. 13B is a cross-sectional view of the torque limiter along lines 13B-13B as depicted in FIG. 13A.

[0044] FIG. 14 is a perspective view of a torsion spring.

[0045] FIG. 15 is a perspective view of a first rotational body of a rotational assembly of the torque limiter.

[0046] FIG. 16 is a perspective view of a second rotational body of the rotational assembly of the torque limiter.

[0047] FIG. 17A is a cross-sectional view of the torque limiter generally along the line 17A-17A as depicted in FIG. 13B.

[0048] FIG. 17B is a cross-sectional view of the torque limiter generally along the line 17B-17B as depicted in FIG. 13B.

[0049] FIG. 18 is a cross-sectional view of the torque limiter disposed within a housing. [0050] FIG. 19 is a cross-sectional view of the torque limiter within a housing taken along the line 19-19 as depicted in FIG. 18.

[0051] FIGS. 20A and 20B illustrate approximation of the arms of the torsion spring during twisting of the torsion spring.

[0052] FIG. 21 A is a cross-sectional view of a proximal end portion of the handle depicting a load cell mounted to the body of the handle.

[0053] FIG. 21B is a portion of the handle depicting a plate extension on the gearbox in contact with the load cell.

[0054] FIG. 22A is a top view of the gearbox housing.

[0055] FIG. 22B is a side view of the gearbox housing.

[0056] FIG. 22C is a proximal end view of the gearbox housing.

[0057] FIG. 22D is a cross-sectional view of the gearbox housing along line 22D-22D as depicted in FIG. 22B.

[0058] FIG. 22E is a cross-sectional view of the gearbox housing along line 22E-22E as depicted in FIG. 22B.

[0059] FIG. 22F is a cross-sectional view of the gearbox housing along line 22F-22F as depicted in FIG. 22B.

[0060] FIG. 22G is a cross-sectional view of the gearbox housing along line 22G-22G as depicted in FIG. 22B.

[0061] FIG. 22H is a cross-sectional view of the gearbox housing along line 22H-22H as depicted in FIG. 22B.

[0062] FIG. 221 is a perspective view of a distal end portion of the gearbox housing.

[0063] FIG. 22J is a distal end view of the gearbox housing.

[0064] FIG. 22K is a perspective view of the gearbox illustrating an encoder mounted on an output shaft.

[0065] FIG. 23 is a perspective view of a portion of the handle depicting a pull body coupled to a knob and the gearbox. [0066] FIG. 24A is a perspective view of a portion of the handle depicting a pull body coupled to the gearbox.

[0067] FIG. 24B is a perspective view of the pull body viewed from an end of the pull body.

[0068] FIG. 24C is a perspective view of the pull body.

[0069] FIG. 24D is a cross-sectional view of the pull body along a plane extending along line 24D-24D as depicted in FIG. 24C.

[0070] FIG. 24E is a cross-sectional view of a portion of the handle along a plane extending along line 24E-24E as depicted in FIG. 24A with slider arms of the pull body abutting first stop surfaces on the gearbox housing.

[0071] FIG. 24F is a cross-sectional view as depicted in FIG. 24E with slider arms of the pull body abutting second stop surfaces on the gearbox housing.

[0072] FIG. 24G is a cross-sectional view of a portion of the handle along a plane extending along line 24G-24G as depicted in FIG. 24A.

[0073] FIG. 25 A is a cross-sectional of a knob having inner channels.

[0074] FIG. 25B is a cross-sectional view of the knob along a plane extending along line

25B-25B as depicted in FIG. 25 A.

[0075] FIG. 26 is a cross-sectional view of the handle along line 26-26 as depicted in FIG. 4A.

[0076] FIG. 27 is a cross-sectional view of a proximal end portion of the handle including a mechanism for preventing backlash.

[0077] FIG. 28A is a perspective view of the cross-sectional view depicted in FIG. 27.

[0078] FIG. 28B is an end view of a disc portion of the input shaft depicted in FIG. 27, illustrating a first movement of a pin during rotation of a knob.

[0079] FIG. 28C is an end view of the disc portion of the input shaft depicted in FIG. 28B, illustrating a second movement of the pin after release of the knob.

[0080] FIG. 29 is a cross-sectional view of the proximal end portion of the handle depicted in FIG. 27 with the knob in a tilted position. [0081] FIG. 30 is a cross-sectional view of a knob assembly including a mechanism for preventing backlash, according to another example.

[0082] FIG. 31 illustrates the knob assembly of FIG. 30 with a tiltable locker member in a tilted position.

[0083] FIG. 32 is a cross-sectional view of a knob assembly including a mechanism for preventing backlash, according to another example.

[0084] FIG. 33A is an end view of a disc portion of the input shaft depicted in FIG. 30 illustrating a first movement of a pin during rotation of a knob.

[0085] FIG. 33B is an end view of the disc portion of the input shaft depicted in FIG. 33A illustrating a second movement of the pin after release of the knob.

[0086] FIG. 34 is cross-sectional view of the handle as depicted in FIG. 8 with the knob assembly as depicted in FIG. 30.

[0087] FIG. 35 is a portion of a handle depicting a gearbox mounted on a support shaft coupled to the handle body.

[0088] FIG. 36 is a portion of a handle depicting a flexible coupling disposed between a knob and a gearbox.

[0089] FIG. 37 is a portion of a handle as depicted in FIG. 36 illustrating coupling of the knob to an input gear within the gearbox using the flexible coupling.

[0090] FIG. 38 is a perspective view of the jaw coupling of the flexible coupling.

[0091] FIG. 39 is a cross-sectional view of the handle as depicted in FIG. 37 along line 39-

39.

[0092] FIG. 40 is a cross-sectional view of the handle as depicted in FIG. 37 along line 40-

40.

[0093] FIG. 41 is a portion of a handle depicting a flexible coupling disposed between a knob assembly having a backlash prevention mechanism and a gearbox.

[0094] FIG. 42 is a cross-sectional view of a proximal end portion of a handle including a knob assembly with a knob and a mechanism for preventing backlash. [0095] FIG. 43 is a cross-sectional view of the knob assembly as depicted in FIG. 42 along line 43-43.

[0096] FIG. 44A is a cross-sectional view of a proximal end portion of a handle as depicted in FIG. 42 illustrating an initial state of the backlash mechanism.

[0097] FIG. 44B is a detail of 44A as depicted in FIG. 44A.

[0098] FIG. 45 A is a cross-sectional view of a proximal end portion of a handle as depicted in FIG. 42 illustrating rotation of the knob in a counterclockwise direction to release rotational locks of the backlash mechanism.

[0099] FIG. 45B is a detail of 45A as depicted in FIG. 45 A.

[0100] FIG. 46A is a cross-sectional view of a proximal end portion of a handle as depicted in FIG. 42 illustrating further rotation of the knob in the counterclockwise direction to engage rotatable members of the backlash mechanism.

[0101] FIG. 46B is a detail of 46A as depicted in FIG. 46A.

[0102] FIG. 47A is a cross-sectional view of a proximal end portion of a handle as depicted in FIG. 42 illustrating return of the backlash mechanism to the initial state.

[0103] FIG. 47B is a detail of 47B as depicted in FIG. 47B.

[0104] FIG. 48 is a perspective view of a proximal end portion of a handle including a knob assembly having a knob (depicted as transparent) and a mechanism for preventing backlash.

[0105] FIG. 49 is a cross-sectional view of the proximal end portion shown in FIG. 48.

[0106] FIG. 50A is a perspective view of a proximal end portion of a handle as depicted in FIG. 48 illustrating an initial state of the knob assembly without rotation of the knob (depicted as transparent).

[0107] FIG. 50B is a distal end view of the knob assembly in the state depicted in FIG. 50A.

[0108] FIG. 51A is a perspective view of a proximal end portion of a handle as depicted in FIG. 48 illustrating rotation of the knob (depicted as transparent) in a counterclockwise direction to release rotational locks of the backlash mechanism. [0109] FIG. 51B is a distal end view of the knob assembly in the state depicted in FIG.

51A.

[0110] FIG. 52 A is a perspective view of a proximal end portion of a handle as depicted in FIG. 48 illustrating further rotation of the knob (depicted as transparent) in the counterclockwise direction to engage rotatable members of the backlash mechanism.

[0111] FIG. 52B is a distal end view of the knob assembly in the state depicted in FIG. 52A.

101121 FIG. 53A is a perspective view of a proximal end portion of a handle as depicted in

FIG. 48 illustrating release of the knob (depicted as transparent) and return of the knob assembly to the initial state.

[0113] FIG. 53B is a distal end view of the knob assembly in the state depicted in FIG. 53A.

[0114] FIG. 54 A is a perspective view of a proximal end portion of a handle as depicted in FIG. 48 illustrating rotation of the knob (depicted as transparent) in a clockwise direction to release rotational locks of the backlash mechanism.

[0115] FIG. 54B is a distal end view of the knob assembly in the state depicted in FIG. 54A.

[0116] FIG. 55 A is a perspective view of a proximal end portion of a handle as depicted in FIG. 48 illustrating further rotation of the knob (depicted as transparent) in the clockwise direction to engage rotatable members of the backlash mechanism.

[0117] FIG. 55B is a distal end view of the knob assembly in the state depicted in FIG. 55A.

DETAILED DESCRIPTION

[0118] General Considerations

[0119] The subject matter is described with implementations and examples. In some cases, as will be recognized by one skilled in the art, the disclosed implementations and examples may be practiced without one or more of the disclosed specific details, or may be practiced with other methods, structures, and materials not specifically disclosed herein. All the implementations and examples described herein and shown in the drawings may be combined without any restrictions to form any number of combinations, unless the context clearly dictates otherwise, such as if the proposed combination involves elements that are incompatible or mutually exclusive. The sequential order of the acts in any process described herein may be rearranged, unless the context clearly dictates otherwise, such as if one act requires the result of another act as input.

[0120] In the interest of conciseness, and for the sake of continuity in the description, same or similar reference characters may be used for same or similar elements in different figures, and description of an element in one figure will be deemed to carry over when the element appears in other figures with the same or similar reference character. In some cases, the term “corresponding to” may be used to describe correspondence between elements of different figures. In an example 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 stated otherwise.

[0121] The word “comprise” and derivatives thereof, such as “comprises” and “comprising”, are to be construed in an open, inclusive sense, that is, as “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 of elements, means any one or more of the listed elements. The term “or” is generally employed in its broadest sense, that is, as meaning “and/or”, unless the context clearly dictates otherwise.

[0122] The term “coupled” without a qualifier generally means physically coupled or linked and does not exclude the presence of intermediate elements between the coupled elements absent specific contrary language. The term “plurality” or “plural” when used together with an element means two or more of the element. Directions and other relative references (e.g., inner and outer, upper and lower, above and below, left and right, and proximal and distal) may be used to facilitate discussion of the drawings and principles herein but are not intended to be limiting.

[0123] The terms “proximal” and “distal” are defined relative to the use position of a delivery apparatus. In general, the end of the delivery apparatus closest to the user of the apparatus is the proximal end, and the end of the delivery apparatus farthest from the user (e.g., the end that is inserted into a patient’s body) is the distal end. The term “proximal” when used with two spatially separated positions or parts of an object can be understood to mean closer to or oriented towards the proximal end of the delivery apparatus. The term “distal” when used with two spatially separated positions or parts of an object can be understood to mean closer to or oriented towards the distal end of the delivery apparatus.

[0124] Intro to the Disclosed Technology

[0125] Described herein are prosthetic heart valves, delivery apparatus, and methods for implanting prosthetic heart valves. The prosthetic heart valves can include two or more actuators that can be operated to radially expand or radially compress the prosthetic heart valve. The delivery apparatus can include actuator drivers to releasably engage and operate the actuators.

[0126] In some examples, the delivery apparatus can include a counter-rotation mechanism operatively coupled to the actuators such that a net moment force on the prosthetic heart valve while operating the actuators is substantially zero. During expansion of the prosthetic heart valve using the actuators, the counter-rotation movement of the actuators can help maintain the prosthetic heart valve at a rotationally fixed position relative to the native anatomy.

[0127] In some examples, the counter-rotation mechanism can include a gearbox pivotably mounted within a handle of the delivery apparatus and coupled to the actuator drivers. In some examples, a stop member can be arranged within the handle to engage and limit pivoting of the gearbox during expansion of the prosthetic heart valve. In some examples, the stop member can include a sensor to measure load on the gearbox while the gearbox is engaged with the stop member.

[0128] In some examples, the delivery apparatus can include a mechanism that limits the torque applied to an actuator driver during expansion of the prosthetic heart valve. The torque limiter can be configured to halt a gear train of the gearbox once the torque applied to the actuator driver is within a tolerance of a predetermined maximum torque.

[0129] In some examples, the delivery apparatus can include a shaft and a knob coupled to the shaft such that the shaft can be rotated by rotating the knob. In some examples, the delivery mechanism can include a mechanism that prevents backlash when the knob is released. In some examples, the shaft can be coupled to a gear train. In some examples, the delivery apparatus can include a mechanism that prevents the shaft from transferring lateral displacements or vibrations to the gear train when the shaft is rotated by the knob.

[0130] Examples of the Disclosed Technology

[0131] FIG. 1 illustrates a prosthetic heart valve 100, according to one example. The prosthetic heart valve 100 can be configured to replace a native heart valve (e.g., aortic, mitral, pulmonary, and/or tricuspid valves). The prosthetic heart valve 100 is illustrated as a mechanically expandable prosthetic heart valve that can be radially compressed for delivery to an implantation location within a patient’ s body and then radially expanded to a working diameter at the implantation location. The prosthetic heart valve 100 can include a frame 104 having an annular shape. The prosthetic heart valve 100 can further include a valvular structure 108 supported within and coupled to the frame 104.

[0132] In the example, the valvular structure 108 includes one or more leaflets 112 made of flexible material and configured to open and close to regulate blood flow. In one example, the valvular structure 108 can have three leaflets 112, which can be arranged to collapse in a tricuspid arrangement. The leaflets 112 can be made in whole or in part from pericardial tissue (e.g., bovine pericardial tissue), biocompatible synthetic materials, or various other suitable natural or synthetic materials.

[0133] As illustrated more clearly in FIG. 2A, the frame 104 has an inflow end 116, an outflow end 120, and a longitudinal axis L extending in a direction from the inflow end 116 to the outflow end 120. The frame 104 can include a plurality of support posts 124, 128 aligned with the longitudinal axis L and spaced along a circumference of the frame 104. In one example, the support posts 124, 128 can be arranged in an alternating manner along the circumference of the frame 104. The frame 104 can further include a plurality of stmts 132 extending circumferentially between adjacent support posts 124, 128 and interconnecting the support posts 124, 128. The stmts 132 and support posts 124, 128 define cells 136 of the frame 104. As illustrated, the stmts 132 can have a curved shape.

[0134] As illustrated in FIGS. 1 and 2A, one or more commissure windows 140 can be formed in one or more of the support posts 124. Commissures 144 can be formed at the commissure windows 140 to couple the leaflets 112 to the frame 104. One or more of the support posts 124 can further include cantilevered struts 148 extending to the inflow end 116 of the frame 104. In some cases, inflow edge portions 152 of the leaflets 112 can be attached to the cantilevered struts 148 (e.g., by sutures 154) and/or to selected struts 132 of the frame 104 (e.g., using sutures 156).

[0135] In one example, the frame 104 can be adjusted between a radially expanded configuration and a radially compressed configuration by deflecting the struts 132. In one example, the frame 104 (e.g., the posts and struts) can be made of biocompatible plastically - expandable materials that will allow the frame 104 to be adjusted between the radially expanded configuration and radially compressed configuration. Suitable examples of plastically-expandable materials that can be used in forming the frame 104 include, but are not limited to, stainless steel, cobalt chromium alloy, and/or nickel titanium alloy (which can also be referred to as “NiTi” or “nitinol”).

[0136] Referring to FIG. 2A, in one example, one or more actuators 168 can be coupled to the support posts 128 and used to adjust the frame 104 between the radially expanded configuration and the radially compressed configuration. In one example, each support post 128 can include an upper post member 160 and a lower post member 164 (the terms “upper” and “lower” are relative to the orientation of the frame 104 in FIG. 1) aligned with the longitudinal axis L of the frame 104 and having opposing ends separated by a gap G. The respective actuator 168 can be coupled to the post members 160, 164 and operable to increase or decrease the gap G in order to radially compress or expand the frame 104.

[0137] In one example, the actuator 168 can include an actuator rod 172 with an attached actuator head 176. In the examples illustrated 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 example illustrated 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 retained at the outflow apex of the upper post member 160. In the example illustrated 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 retained at the inflow apex of the lower post member 164.

[0138] In some examples, the actuator rod 172 is externally threaded. As illustrated in FIGS. 2A and 2B, the lower post member 164 can include a nut 180 with an internal thread to threadedly engage the actuator rod 172. In this case, the actuator rod 172 can be translated in a longitudinal direction by rotating the actuator rod 172 relative to the nut 180. In some examples, the actuator rod 172 can be freely slidable relative to the upper post member 160. In other examples, the actuator rod 172 can threadedly engage the upper post member 160.

[0139] As illustrated in FIG. 3, the actuator head 176 can include a pair of protrusions 184 forming a slot 188. The actuator head 176 can further include one or more shoulders 192. As will be further described, an actuation assembly of the delivery apparatus can releasably engage the actuator head 176 via the slot 188 and shoulders 192.

[0140] Referring to FIGS. 2A and 2B, in one scenario, the actuator rod 172 can be rotated in a first direction to move the upper post member 160 towards the lower post member 164 and thereby decrease the size of gap G, which can have the effect of radially expanding the frame 104. In another scenario, the lower post member 164 may 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 and thereby increase the size of 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) may be installed on the actuator rod 172 to limit the travel of the actuator rod 172 while rotating the actuator rod 172 to radially compress the frame 104.

[0141] In some examples, as will be further described, some of the actuator rods 172 can be rotated in one direction while the other actuator rods 172 are rotated in an opposite direction simultaneously to either radially expand the frame or radially compress the frame. This counter-rotation of the actuator rods can be used to help reduce the likelihood of the entire frame 104 rotating about the longitudinal axis L during rotation of the actuator rods 172 about their respective axes (e.g., when radially expanding the frame 104).

[0142] Additional examples of mechanically expandable valves can be found in International Application No. PCT/US2021/052745 and U.S. Provisional Application No. 63/209904, which are incorporated by reference herein.

[0143] FIGS. 4A and 4B illustrate a delivery apparatus 200, according to one example. The delivery apparatus 200 can be used to deliver the prosthetic heart valve 100 to an implantation location within a patient’s body. The delivery apparatus 200 includes a handle 204 and a shaft assembly 208 coupled to the handle 204. The delivery apparatus 200 can further include one or more actuation assemblies 220 that can be used to releasably 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.

[0144] The prosthetic heart valve 100 is shown in an expanded configuration in FIG. 4B. To facilitate delivery of the prosthetic heart valve 100 to an implantation location, the delivery apparatus 200 (and/or other crimping devices) can be used to move the prosthetic heart valve 100 from a radially expanded, functional configuration to a radially compressed, delivery configuration. Once at the implantation location, actuation drivers of the actuation assemblies 220 can operate the actuators 168 of the prosthetic heart valve 100 to radially expand the prosthetic heart valve 100 to a working diameter.

[0145] In one example, the handle 204 includes a handle body having a proximal body portion 212 and a distal body portion 216 coupled together. The body portions 212, 216 define a cavity (depicted as 205 in FIG. 8) extending along a longitudinal axis LI of the handle 204. Various mechanisms of the delivery apparatus 200 are disposed within the cavity 205.

[0146] As illustrated in FIGS. 4B and 5, the shaft assembly 208 can include an outer delivery shaft 224 having a lumen 225 extending along the entire length of the shaft. The shaft assembly 208 can include a multi-lumen delivery shaft 228 extending through the lumen 225 and having lumens 234, 242. The shaft assembly 208 can include a nosecone shaft 232 extending through the lumen 234. The actuation assemblies 220 can extend through the lumens 242. The lumen 234 can be centrally disposed within the multi-lumen delivery shaft 228, and the lumens 242 can be angularly spaced apart (uniformly or non- uniformly) about a central axis of the multi-lumen delivery shaft 228 and disposed around the lumen 234.

[0147] In one example, the proximal end portion of the nosecone shaft 232 extends into the portion of the cavity of the handle 204 defined in the proximal body portion 212 (indicated in FIG. 4A), and the 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 can be disposed around the distal end portion of the nosecone shaft 232 when releasably coupled to the actuation assemblies 220. [0148] The nosecone shaft 232 can define a guidewire lumen 236 for receiving a guidewire. As shown in FIG. 4B, a nosecone 240 can be attached to a distal end of the nosecone shaft 232. The nosecone 240 can have a central opening 241 that is aligned and connected to the guidewire lumen 236. During an implantation procedure, a guidewire can be initially inserted into a patient’s vasculature. The proximal end of the guidewire can be inserted into the central opening 241 of the nosecone 240 to allow the delivery apparatus 200 to be advanced through the patient’ s vasculature to an implantation location over the guidewire.

[0149] FIG. 6 illustrates a distal end portion of the actuation assembly 220. Each actuation assembly 220 can include an outer sleeve 244 and an actuator driver 248 extending through the outer sleeve 244. In the example, the actuator driver 248 includes a distal head having a central protrusion 252 and one or more flexible elongated elements 254. The central protrusion 252 can be configured to extend into the slot 188 (shown in FIG. 3) of the actuator head 176 of an actuator 168 of the prosthetic heart valve. The flexible elongated elements 254 can have radial protrusions 256 configured to engage the shoulders 192 (shown in FIG. 3) of the actuator head 176.

[0150] FIGS. 7A-7C illustrate engagement of an actuation assembly 220 with a respective actuator 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. 7 A. The distal end portion of the actuator driver 248 is then advanced such that the central protrusion 252 of the actuator driver 248 is disposed within the slot 188 of the actuator head 176 of the actuator 168. When the central protrusion 252 is engaged with the slot 188, the flexible elongated elements 254 are disposed at the sides of the actuator head 176, and the radial protrusions 256 of the flexible elongated elements 254 are positioned distally to the shoulders 192 on the actuator head 176, as shown in FIG. 7B.

[0151] The outer sleeve 244 can be advanced over the distal end portion of the actuator driver 248 to radially compress the flexible elongated elements 254 against the actuator head 176 until the radial protrusions 256 abut the shoulders 192, thereby coupling the actuator driver 248 to the actuator 168. The outer sleeve 244 can be further advanced until the outer sleeve 244 engages the frame 104, as illustrated in FIG. 7C. [0152] The outer sleeve 244 can have first and second support extensions 260 defining gaps or notches 262 between the support extensions 260. As illustrated in FIG. 7C, the support extensions 260 can be oriented such that when the actuation assembly 220 is coupled to a respective actuator 168, the support extensions 260 extend partially over a proximal end portion of the upper post arm 160 of the respective support post 128. The engagement of the support extensions 260 with the frame 104 can counteract rotational forces applied to the frame 104 by the actuator rods 172 during expansion of the frame 104.

[0153] Various other coupling mechanisms can be used to releasably couple the prosthetic heart valve to the actuation assembly of the delivery apparatus. For example, additional coupling mechanisms are described in U.S. Application No. 63/194,285 and U.S. Patent Application having attorney docket no. 12052US01, which are incorporated by reference herein.

[0154] As shown in FIG. 4A, the handle 204 can include one or more knobs that can be configured to perform various functions of the delivery apparatus 200 to deliver the prosthetic heart valve 100 to an implantation location within a patient’s body. In one example, the handle 204 can include a first knob 264, a second knob 268, and a third knob 272. In one example, the knobs 264, 268, 272 can be knobs that are rotatable about the longitudinal axis LI of the handle 204 and relative to the body portions 212, 216 of the handle. The handle 204 can include other knobs that can be rotatable or slidable, such as a safety knob 276.

[0155] In the example, the first knob 264 is located at a proximal end of the handle 204 and can be used to operate the actuation assemblies 220 of the delivery apparatus 200 and the actuators 168 of the prosthetic heart valve 100. As illustrated in FIG. 8, the first knob 264 can be configured to operate a gearbox 300 disposed within a proximal portion of the cavity 205 of the handle 204. The actuator drivers 248 of the actuation assemblies 220 can be coupled to the gearbox 300 in order to be rotated by the gearbox 300. The rotation of the actuator drivers 248 can be translated to rotational motion of the actuators 168 of the prosthetic heart valve 100.

[0156] In the example, the second knob 268 is located where the proximal and distal body portions 212, 216 of the handle 204 are coupled together. The second knob 268 can be configured to release the actuation assemblies 220 from the prosthetic heart valve 100 (e.g., after positioning the prosthetic heart valve 100 at the desired implantation location and expanding the prosthetic heart valve 100 to the working diameter). In one example, the safety knob 276 can be configured to prevent unintentional release of the actuation assemblies 220 from the prosthetic heart valve. For example, the safety knob 276 can slide into a recess in the second knob 268 to prevent rotation of the second knob 268. Retraction of the safety knob 276 from the recess can allow the second knob 268 to be rotated.

[0157] In the example, the third knob 272 is located at a distal end of the handle 204. The third knob 272 can be configured such that rotation of the knob relative to the handle body results in the outer delivery shaft 224 moving axially relative to the actuation assemblies 220, the prosthetic heart valve 100, and the nosecone shaft 232.

[0158] In one example, a delivery capsule 226 (shown in FIG. 4B) can be attached to a distal end of the outer delivery shaft 224. Axial movement of the outer delivery shaft 224 in a distal direction relative to the other shafts and prosthetic valve can move the delivery capsule 226 over the distal end portions of the actuation assemblies 220 and the prosthetic heart valve 100 (i.e., when the prosthetic heart valve 100 is in the radially compressed configuration) such that the prosthetic heart valve 100 is enclosed within the delivery capsule. Axial movement of the outer delivery shaft 224 in a proximal direction relative to the other shafts and the prosthetic valve can retract the delivery capsule 226 from the prosthetic heart valve 100, exposing the prosthetic heart valve, for example, for deployment at an implantation location. In some examples, the third knob 272 can be operatively coupled to a carriage 280 within the distal portion of the cavity 205 of the handle 204. The outer delivery shaft 224 can be coupled to the carriage 280 such that movement of the carriage 280 due to rotation of the third knob 272 results in axial displacement of the outer delivery shaft 224.

[0159] During expansion of the prosthetic heart valve 100, rotation of the actuators 168 can apply moment forces to the frame 104, i.e., due to the frictional forces acting between the frame 104 and the actuator rods 172 of the actuators 168. These moment forces can, in some instances, result in the frame 104 rotating or pivoting about the longitudinal axial L of the frame during the expansion/contraction procedure. To help reduce such rotation of the entire frame, the actuators 168 can be divided into two sets, and the two sets can be rotated in opposite directions such that the moment forces due to one set of actuators is counterbalanced by the moment forces due to the other set of actuators. This can, for example, help the frame 104 to remain rotationally fixed or at least substantially rotationally fixed during expansion of the prosthetic heart valve. Thus, this configuration can, for example, make positioning and/or deploying a prosthetic heart valve relatively easier and/or predictable.

[0160] As illustrated in FIGS. 9A-9C, the gearbox 300 of the handle 204 can include a gearbox housing 304 with various compartments 306 to hold the components of a gear train 308. The output shafts of the gear train 308 can be coupled to the actuator drivers 248 such that operation of the gear train 308 results in rotation of the actuator drivers 248 and consequently rotation of the actuators 168 of the prosthetic heart valve 100. In one example, the gearbox 300 can be a counter-rotation gearbox where the gear train 308 is configured to rotate two sets of actuator drivers in opposite directions.

[0161] FIGS. 10A-10C illustrate one example of the gear train 308. In the example, the gear train 308 includes an input shaft 324 and an input gear 320 coupled to the input shaft 324. In one example, the input shaft 324 is aligned with the longitudinal axis LI of the handle 204 (as depicted in FIG. 8). The input shaft 324 can be coupled to the first knob 264 of the handle 204 (as depicted in FIG. 8) such that rotation of the first knob 264 results in rotation of the input shaft 324. The input gear 320 rotates with the input shaft 324. The rotational direction R1 of the input gear 320 can be clockwise or counterclockwise, depending on the direction in which the first knob 264 is rotated.

[0162] The gear train 308 can include a transmission gear 328 coupled to a transmission shaft 332, which can be arranged in parallel to the input shaft 324. The teeth of the input gear 320 are meshed 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 one example, rotation of the input gear 320 in a first direction R1 drives the transmission gear 328 in a second direction R2 that is opposite to the first direction (whether R2 is clockwise or counterclockwise will depend on the rotational direction R1 as determined by the rotation of the first knob 264).

[0163] The gear train 308 can include a first driving gear 336 coupled to the transmission shaft 332 and disposed distally to the transmission gear 328. In this case, rotation of the transmission shaft 332 in response to driving the transmission gear 328 by the input gear 320 is translated to rotation of the first driving gear 336. The first driving gear 336 rotates in the same direction R2 as the transmission gear 328. [0164] The gear train 308 can include a second driving gear 340 supported on a driving shaft 342 that is arranged in parallel to the transmission shaft 332. The teeth of the second driving gear 340 are meshed with the teeth of the first driving gear 336 such that rotation of the first driving gear 336 drives the second driving gear 340. The driving shaft 342 rotates with the second driving gear 340. The second driving gear 340 rotates in a direction R1 that is opposite to the direction R2 in which the first driving gear 336 rotates.

[0165] The gear train 308 can include a set of first output gears (which can also be referred to as “pinion gears”) angularly spaced apart about a central axis of the first driving gear 336 and having teeth meshed with the teeth of the first driving gear 336. In the example, the set of first output gears includes output gears 344a, 344b, 344c. The output gears 344a, 344b, 344c rotate in a direction R1 that is opposite to the direction R2 in which the first driving gear 336 is rotating. In one example, the output gears 344a, 344b, 334c are coupled to output shafts 346a, 346b, 346c, respectively. The output shafts 346a, 346b, 346c can be coupled to a first set of actuator drivers.

[0166] The gear train 308 can include a second set of output gears (which can also be referred to as “pinion gears”) angularly spaced apart about a central axis of the second driving gear 340 and having teeth meshed with the teeth of the second driving gear 340. In the example, the second set of output gears includes output gears 344d, 344e, 344f. The output gears 344d, 344e, 344f rotate in a direction R2 that is opposite to the direction R1 in which the second driving gear 340 is rotating. As such, the output gears 344d, 344e, 344f of the second set of output gears rotate in a direction that is opposite to the direction in which the output gears 344a, 344b, 344c of the first set of output gears rotate. In one example, the output gears 344d, 344e, 344f are coupled to output shafts 346d, 346e, 346f, respectively. The output shafts 346d, 346e, 346f can be coupled to a second set of actuator drivers.

[0167] For illustrative purposes, FIG. 11 shows the frame 104 with actuators 168a, 168b, 168c, 168d, 168e, 168f coupled to support posts 128a, 128b, 128c, 128d, 128e, 128f, respectively. In one example, a first set of actuators can include actuators 168a, 168b, 168c, and a second set of actuators can include actuators 168d, 168e, 168f. The first set of actuators 168a, 168b, 168c can be coupled to the first set of actuator drivers 248a, 248b, 248c, and the second set of actuators 168d, 168e, 168f can be coupled to the second set of actuator drivers 248d, 248e, 248f, as illustrated in FIG. 12 (several details of the delivery apparatus are not shown in FIG. 12 for simplicity; for example, the body of the handle 204 and the outer delivery shaft 224 through which the multi-lumen delivery shaft 228 extends are not shown).

[0168] Returning to FIG. 11, the actuator rods 172a, 172b, 172c of the actuators 168a, 168b, 168c in the first set of actuators can have threads with a first configuration (e.g., righthand threads). The actuator rods 172d, 172e, 172f of the actuators 168d, 168e, 168f in the second set of actuators can have threads with a second configuration (e.g., left-hand threads) that are opposite to the first configuration. For example, if the actuator rods 172a, 172b, 172c have right-hand threads, the actuator rods 172d, 172e, 172f can have left-hand threads (or vice versa). Thus, when the actuators 168a, 168b, 168c in the first set and the actuators 168d, 168e, 168f in the second set are simultaneously rotated in opposite directions, all the actuators will act in concert to either increase the respective gap G or decrease the gap G.

[0169] Other examples of dividing the actuators into two sets are possible. For example, a first set of actuators could include actuators 168a, 168c, 168e, and a second set of actuators could include actuators 168b, 168d, 168f (i.e., alternating actuators around the circumference of the frame could be included in a set). In this case, the actuator rods 172a, 172c, 172e of the first set of actuators can have threads with a first configuration (e.g., right-hand threads), and the actuator rods 172b, 172d, 172f of the second set of actuators can have threads with a second configuration that is opposite to the first configuration (e.g., left-hand threads).

[0170] Examples have been given with the prosthetic heart valve 100 having six actuators divided into two sets. In other examples, the prosthetic heart valve could have greater than six (e.g., 7-15) or fewer than six (e.g., 1-5) actuators. In other cases, the prosthetic heart valve could have an odd number of actuators, in which case one set of actuators could have a greater number of actuators compared to the other set of actuators. The number of actuation assemblies/actuator drivers of the delivery apparatus can generally match the number of actuators of the prosthetic heart valve.

[0171] In the simplified illustration of FIG. 12, each of the actuator drivers 248a, 248b, 248c in 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 in 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 the 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 the 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.

[0172] To radially expand the prosthetic heart valve 100, for example, at an 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 counter-rotation of the two sets of actuator drivers results in counter-rotation of the first set of actuators 168a, 168b, 168c and the second set of actuators 168d, 168e, 168f. This counterrotation of the two sets of actuators can advantageously help reduce the likelihood of the prosthetic heart valve rotating relative to the native anatomy during expansion of the prosthetic heart valve.

[0173] hi some examples, a torque limit can be defined for each actuator driver 248, and one or more torque limiters can be provided (e.g., one for each actuator driver 248) to prevent torque on the actuator driver 248 from exceeding the predefined limit. The torque limiter can, for example, prevent overloading of the actuator driver 248 during expansion of the prosthetic heart valve 100. In one example, the torque limiter restricts rotation of the corresponding actuator driver 248 when the torque on the actuator driver 248 has reached a predefined limit. Since all the actuator drivers 248 are coupled to the gear train 308, the gear train 308 effectively halts when any of the actuator drivers 248 is stopped by the torque limiter.

[0174] FIGS. 13A and 13B illustrate a torque limiter 400, according to one example. The torque limiter 400 can couple an actuator driver 248 to an output shaft 346 of the gear train 308 and can operate to prevent rotation of the actuator driver 248 when a torque on the actuator driver 248 is within a predetermined torque limit range. The upper limit of the predefined torque limit range can be a maximum torque on the actuator driver 248, and the lower limit of the predetermined torque limit range can be a torque that is within a tolerance of the maximum torque (e.g., within 15% of the maximum torque). In one example, the maximum torque on the actuator driver 248 can be 50 N-mm. The torque limiter 400 can 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. Although only one torque limiter 400 is depicted in FIGS. 9B and 9C, in some examples, the handle 204 for the delivery apparatus 200 can comprise a plurality (e.g., 2-15) of torque limiters 400. For example, each actuation driver 248 of the delivery apparatus could have a respective torque limiter 400.

[0175] Returning to FIGS. 13A-13B, the torque limiter 400 has a longitudinal axis L2.

The torque limiter 400 includes a rotatable assembly 401 aligned with and rotatable about the longitudinal axis L2. The rotatable assembly 401 couples a connector shaft 402 to one of the output shafts 346 of the gearbox 300. An output gear 344 is coupled to the output shaft 346, as previously described. One of the actuator drivers 248 can 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.

[0176] The rotatable assembly 401 includes a first rotatable body 404 and a second rotatable body 408. In the example, the second rotatable body 408 is positioned distally to the first rotatable body 404, and both the first and second rotatable bodies 404, 408 are rotatable about the longitudinal axis L2. The first rotatable body 404 is fixedly coupled to the output shaft 346 such that the first rotatable body 404 and the output shaft 346 can rotate together about the longitudinal axis L2. In the example, the first rotatable body 404 is positioned distally 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.

[0177] In one example, the first rotatable body 404 includes a proximal axial bore 412 and a distal axial bore 416. A distal end portion of the output shaft 346 is inserted into the proximal axial bore 412 and engages the proximal axial bore 412 in a manner that allows the first rotatable body 404 to rotate with the output shaft 346. In one example, the proximal axial bore 412 can have a non-circular cross-sectional profile (taken in a plane perpendicular to the longitudinal axis L2) that is adapted to match with a non-circular cross-sectional profile (taken in a plane perpendicular to the longitudinal axis L2) on the output shaft 346 such that rotation of the output shaft 346 results in rotation of the first rotatable body 404. For example, the non-circular cross-sectional profile of the proximal axial bore 412 can be “D shaped” (which can also be referred to as having a “flat”) that can engage a similarly D- shaped (or “flat”) output shaft 346 and allow the first rotatable body 404 to rotate in the same direction as the output shaft 346. In some examples, the output shaft 346 can be attached to the proximal axial bore 412 (e.g., by other means for fixedly coupling such as welding, gluing, and the like) to allow the first rotatable body 404 to rotate with the output shaft 346.

[0178] The second rotatable body 408 can include an axial bore 420 that is aligned 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 into the distal axial bore 416 of the first rotatable body 404. The connector shaft 402 can engage the second rotatable body 408 in a manner that allows the connector shaft 402 to rotate with the second rotatable body 408. For example, the axial bore 420 can have a non-circular profile to engage a complementary noncircular profile on the connector shaft member 402. In some examples, the connector shaft 402 can be attached to the axial bore 420 (e.g., by welding, gluing, and the like) to allow the second rotatable body 408 to be rotatable with the connector shaft 402. In some examples, the distal end of the output shaft 346 and the proximal end of the connector shaft 402 can be axially spaced apart (e.g., separated by a wall or shoulder of the first rotatable body 404).

[0179] In other examples, the opposing ends of the connector shaft 402 and output shaft 346 can axially overlap. In such example, the shafts 402, 346 can 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 output shaft 346. For example, in some instances, the connector shaft 402 (or at least a portion thereof) can comprise an outer diameter that is smaller than a diameter of an internal bore of the output shaft 346 such that the connector shaft can extend axially into the output shaft 346 (or vice versa).

[0180] In any event, the output shaft 346 and the connector shaft 402 are not fixedly coupled together. Thus, in some instances, which are further explained below, the output shaft 346 (and the first rotatable body 404) and the connector shaft 402 (and the second rotatable body 408) can rotate relative to each other.

[0181] In the example, the first rotatable body 404 and the second rotatable body 408 are coupled together by a rotational biasing member (e.g., a torsion spring 424). As illustrated in FIG. 14, the torsion spring 424 can be a helical torsion spring including a coil portion 426 terminating at opposite ends in first and second end (or arm) portions 428, 430. The first and second end portions 428, 430 of the torsion spring 424 can extend radially outward beyond the coil portion 426 of the torsion spring 424. The torsion spring 424 can be configured such that the first end portion 428 is rotationally offset from the second end portion 430.

[0182] In one example, as illustrated in FIG. 15, the proximal end portion of the second rotatable body 408 can include a recess 432 and a connected lateral slot 436. The recess 432 can be centrally aligned with the longitudinal axis L2 and connected to the axial bore 420. As illustrated in FIG. 16, the distal end portion of the first rotatable body 404 can include a recess 440 and connected lateral slots 442, 444. The recess 440 can be centrally aligned with the longitudinal axis L2 and connected to the distal axial bore 416. The lateral slots 442, 444 are rotationally offset from each other 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 into the distal axial bore 416.

[0183] The coil portion 426 of the torsion spring 424 can be arranged in the chamber formed by the aligned recesses 432, 440 with the first end portion 428 extending into the connected lateral slot 436 (as illustrated in FIG. 17 A) and the second end portion 430 extending into one of the lateral slots 442, 444 in the first rotatable body 404 (as illustrated in FIG. 17B). In this position, the coil portion 426 is disposed around the portion of the connector shaft 402 extending through the recesses 432, 440 (depicted 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 the rotatable bodies 404, 408 can rotate about the central axis of the coil portion 426.

[0184] As illustrated in FIG. 17A, the end portions 430, 428 of the torsion spring 424 can engage surfaces 444a, 436a of the respective receiving slots 444, 436 formed in the rotatable bodies 404, 408. The torsion spring 424 can bias the rotatable bodies 404, 408 into an initial position in which the rotatable bodies 404, 408 rotate together as a single body. The torsion spring 424 is configured to twist in a direction in which the end portions 430, 428 approximate each other when the torque on the actuator driver 248 is within predefined torque limit range. In some cases, the torsion spring 424 can be preloaded, and the torsion spring 424 can start twisting when the torque on the actuator driver 248 exceeds the preload in the torsion spring 424. The preload in the torsion spring 424 can be set as the lower limit of the predetermined range. The upper limit of the predetermined range can be the predetermined torque limit on the actuator driver 248, and the lower limit of the predetermined range can be less than the predetermined torque limit on the actuator driver 248 (e.g., within 10 to 15% of the predetermined torque limit). This means that the torsion spring 424 will start twisting as the actuator driver 248 approaches the predetermined torque limit rather than after the actuator driver 248 reaches or exceeds the predetermined torque limit. In some cases, the predetermined torque limit can be 50 N-mm. The initial angular spacing 429 illustrated in FIG. 17 A corresponds to the initial position of the rotatable bodies 404, 408. The angular spacing 429 becomes smaller as the end portions 430, 428 approximate each other during twisting of the torsion spring 424.

[0185] As illustrated in FIG. 15, tapered recessed portions 448 can be formed on the outer surface 446 of the second rotatable body 408. In the example, each tapered recessed portion 448 includes a first radial shoulder 452, a second radial shoulder 456 spaced from the first radial shoulder 452 in a circumferential direction of the second rotatable body 408, and a portion 446a of the outer surface 446 between the first and second radial shoulders 452, 456. The outer surface portion 446a can be a curved surface in one example.

[0186] 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 in the radial direction (i.e., deep to shallow) from the first radial shoulder 452 to the second radial shoulder 456. Each tapered recessed portion can extend axially along the entire length of the second rotatable body 408 or partially along the length of the second rotatable body 408. In one example, two tapered recessed portions 448 are formed on the outer surface 446. The tapered recessed portions 448 are angularly spaced from each other about a central axis of the second rotatable body 408, which can be the same as the longitudinal axis L2 of the torque limiter. The angular spacing between the two tapered recessed portions 448 can be such that the two tapered recessed portions are diametrically opposed about the central axis of the second rotatable body 408.

[0187] As further illustrated in FIG. 18, the rotatable assembly 401 of the torque limiter 400 can be disposed in a housing 460 such that the outer surface 446 of the second rotatable body 408 is circumscribed by an inner surface 464 of the housing 460. The tapered recessed portions 448 in the outer surface 446 and the inner surface 464 can define circumferentially tapered channels 468 disposed on the periphery of the second rotatable body 408, as illustrated more clearly in FIG. 19. The housing 460 can be a compartment of the gearbox housing 304 (e.g., one of compartments 374a-f illustrated in FIG. 22G) or can be a separate housing that is mounted to the gearbox housing 304.

[0188] As shown more clearly in FIG. 19, each channel 468 accommodates a wedge member 472. In one example, the wedge member 472 can be in the form of a longitudinal rod member. In one example, the wedge members 472 are fixedly coupled to the first rotatable body 404 such that the wedge members 472 rotate with the first rotatable body 404. In one example, proximal portions of the wedge members 472 extend into longitudinal holes 476 in the first rotatable body 404 (shown in FIGS. 13A, 16, 17A, 17B, 19). The wedge members 472 can be held in place in the holes 476 using any suitable method (e.g., by friction, welding, gluing, and the like).

[0189] FIGS. 19, 20A, and 20B illustrate 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 working, the gear train 308 rotates the output shaft 346. The first rotatable body 404 rotates with the output shaft 346. Rotation of the first rotatable body 404 is translated to rotation of the second rotatable body 408 through the torsion spring 424. As the second rotatable body 408 rotates, the actuator driver 248, which is coupled to the second rotatable body 408 via the connector shaft 402, also rotates. In the state shown in FIG. 19, the torsion spring 424 is in its resting, undeflected state, with an initial angular difference 429 between the end portions 428, 430. In this state, the wedge members 472 are freely accommodated in the wide end of the channels 468, and the first and second rotatable bodies 404, 408 rotate together.

[0190] If a torque on the actuator driver 248 reaches a predefined torque limit range set by the size and properties of the torsion spring 424, the coil portion 426 of the torsion spring 424 twists in a manner that approximates the end portions 428, 430 of the torsion spring 424 towards each other. FIG. 20A illustrates an angular spacing 429a between the end portions 428, 430 that is smaller than the initial angular spacing 429 (depicted in FIG. 19) due to the end portions 428, 430 approximating each other (the initial angular spacing 429 shown in FIG. 19 is the sum of the angular spacings 429a, 429b indicated in FIG. 20A). As the torsion spring 424 twists, the first rotatable body 404 rotates relative to the second rotatable body 408 (rather than rotating together), as illustrated in FIG. 20 A. As the first rotatable body 404 rotates relative to the second rotatable body 408, the wedge members 472 move along the tapered channels 468 in a direction from the wide end of the channels to the narrow end of the channels, as illustrated by the arrow 475.

[0191] The first rotatable body 404 stops rotating when the wedge members 472 are pressed against the narrow end of the channels 468 such that further rotational movement of the wedge members 472 within the tapered channels 468 is not possible due to the interference between the surfaces of the housing 460 and the second rotatable body 408 and the wedge members 472, as illustrated in FIG. 20B. In this state, the second rotatable body 408 also stops rotating. Since all the gears of the gear train 308 are interconnected, once the actuator driver 248 reaches a torque limit that halts rotation of the first and second rotatable bodies 404, 408 and the output gear 344 associated with the actuator driver 248, the movement of the entire gear train 308 stops, preventing rotational movement of all other actuator drivers 248 coupled to the gearbox 300.

[0192] In this manner, the torque limiter 400 can help ensure that the actuation members and/or other components of the prosthetic heart valve and/or delivery apparatus are operated within the predetermined torque limits. This can, among other things, reduce or prevent the prosthetic heart valve from being damaged during expansion/contraction and/or prevent the prosthetic heart valve from being overly expanded relative to a native annulus (and/or other native tissue).

[0193] The gearbox housing 304 can include various compartments to accommodate the components of the gear train 308 and torque limiter 400, as illustrated in FIGS. 22A-22J.

[0194] In one example, as shown in FIG. 22A-22D, the gearbox housing 304 can have a first housing section 310 (which can also be referred to as “first gear housing”) forming a proximal end portion of the gearbox housing. The first housing section 310 can include compartments 312 and 314 to accommodate the input gear 320 (shown in FIGS. 10A-10C) and the transmission gear 328 (shown in FIGS. 10A-10C), respectively. The first housing section 310 can include a hole 316 for passage of a proximal end portion of the input shaft 324 (e.g., to allow coupling of the proximal end portion of the input shaft 324 to the first knob 264 (shown in FIG. 12)). The first housing section 310 can include holes 318a-f for passage of proximal end portions of the output shafts 346a-f (shown in FIGS. 10A-10C). The first housing section 310 can further include fastening holes 326 (shown in FIG. 22C) that can receive fasteners, such as bolts, which can be used to fasten the first housing section 310 to other housing sections of the gearbox housing.

[0195] In some cases, the first housing section 310 can include mounting holes 322 for mounting of an encoder about a proximal end portion of one of the output shafts 346a-f. For example, the mounting holes 322 can receive fasteners, such as screws, that are used to attach the encoder to the first housing section 310 and around the respective output shaft. FIG. 22K shows an encoder 311 mounted on one of the output shafts. In one example, the encoder 311 can include a sensing member that can detect the number of rotations of the output shaft. In one example, the encoder can be a magnetic encoder including a magnetic sensor and a magnetic arrangement to generate a magnetic field. The magnetic sensor can detect changes in the magnetic field as the output shaft rotates. Other types of encoders can be used, such as optical encoders.

[0196] In one example, as shown in FIGS. 22A-22E, the gearbox housing 304 can have a second housing section 330 (which can also be referred to as “second gear housing”) disposed adjacent to the first housing section 310. The second housing section 330 includes a central opening 348 and compartments 350a-f formed on the periphery of the central opening 348. The central opening 348 can accommodate the driving 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 in the first housing section 310. The second housing section 330 can include fastening holes 354 that can be aligned with the fastening holes 326 in the first housing section 310 to receive fasteners. The second housing section 330 can include an opening 349 that is aligned with the compartment 312 in the first housing section 310. The opening 349 can allow the input shaft 324 to extend through the second housing section 330 when the input gear 320 is mounted in the compartment 312.

[0197] In one example, as shown in FIGS. 22A, 22B, 22E, and 22F, the gearbox housing 304 can have a third housing section 358 (which can also be referred to as “shaft support”) disposed adjacent to the second housing section 330 and forming an end wall for the central opening 348 and compartments 350a-f in the second housing section 330. The third housing section 358 can include holes 362a-f (shown in FIG. 22F) to receive the output shafts 346a-f (shown in FIGS. 10A-10C) when the output gears 344a-f (shown in FIGS. 10A-10C) are disposed in the compartments 350a-f of the second housing section 330. The third housing section 358 can include holes 366 and 368 to receive the transmission shaft 332 (shown in FIGS. 10A-10C) and the driving shaft 342 when the driving gears 336, 340 are disposed in the central opening 348 of the second housing section 330. The third housing section 358 can include an opening 369 that is aligned with the opening 349 in the second housing section 330. The opening 369 can 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 can include fastening holes 370 that can be aligned with the fastening holes 354 in the second housing section 330 and the fastening holes 326 in the first housing section 310 to receive fasteners.

[0198] In one example, as shown in FIGS. 22A, 22B, and 22G, the gearbox housing 304 can have a fourth housing section 372 (which can also be referred to as “torque limiter housing”) disposed adjacent to the third housing section 358. The fourth housing section 372 can include compartments 374a-f arranged in the same pattern as the holes 362a-f in the third housing section 358 and the compartments 350a-f in the second housing section 330. Each of the compartments 374a-f can accommodate a torque limiter 400 (shown in FIG. 18), which can be coupled to a respective output shaft 346a-f extending through a respective hole 362a-f. The fourth housing section 372 include holes 376a-f in end walls of the compartments 374a-f for passage of the connector shafts 402 of the torque limiters 400 outside of the fourth housing 372 when the rotatable assemblies 401 (shown in FIG. 18) of the torque limiters 400 are accommodated within the compartments 374a-f. The fourth housing section 372 can include fastening holes 378 that can be aligned with the fastening holes 370, 354, 326 in the housing sections 358, 330, 310. The compartments 374a-f can be arranged in a pattern to define a channel 375. The input shaft 324 can extend through the channel 375.

[0199] In one example, as shown in FIGS. 22A, 22B, 22G, and 22H, the gearbox housing 304 can have a fifth housing section 380 disposed adjacent to the fourth housing section 372. The fifth housing section 380 (which can also be referred to as “release housing”) 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 for 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 to receive end portions of the torque limiters 400 (shown in FIG. 18) when the rotatable assemblies 401 of the torque limiters 400 are disposed in the compartments 374a-f of the fourth housing section 372. The base member 381 can include openings 386a-f connected to the receptacles 384a-f such that the coupling sections 403 of the connector shafts 402 of the torque limiters 400 can be mounted in the openings 386a-f, or are accessible through the openings 386a-f, when the rotatable assemblies 401 are disposed in the compartments 374a-f in the fourth housing section 372. The fifth housing section 380 can include fastening holes 388 that can be aligned with the fastening holes 378, 370, 354, 326 in the housing sections 372, 358, 330, 310 to receive fasteners.

[0200] In one example, as shown in FIGS. 22A, 22B, and 22H-22J, the fifth housing section 380 can further include a guide member 389 projecting from the base member 381. The guide member 389 can include a hole 390 aligned with the hole 382 in the plate member 381 to receive an end portion of the input shaft 324. Thus, when the gearbox 300 is fully assembled, the input shaft 324 will extend across all the housing sections 310, 330, 358, 372, and 380 (as shown in FIGS. 24E and 24F). The input shaft 324 defines a longitudinal axis of the gearbox housing, which is also an axis about which the gearbox housing can pivot. The longitudinal axis of the gearbox housing 304 is aligned with the longitudinal axis LI of the handle 204. A pair of guide slots 392 are formed on opposed surfaces (e.g., top and bottom surfaces) 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 opposed end walls forming opposed stop surfaces 393, 394. A pair of guide channels 395 are formed on opposed sides of the guide member 389. The guide channels 395 extend axially in a direction along the longitudinal axis of the gearbox housing. As will be further described, the guide slots 392 and guide channels 395 can guide translation of a pull body along the longitudinal axis LI of the handle.

[0201] The various housing sections 310, 330, 358, 372, and 380 of the gearbox housing 304 can be provided as separate members that are fastened together or as integral portions of the gearbox housing 304. In some cases, two or more of the housing sections 310, 330, 358, 372, and 380 can be integrally formed such that the gearbox housing 304 has fewer components to fasten together. In some cases, the gearbox housing 304 can be provided in two halves that can be fastened together. In other cases, the housing sections of the gearbox housing 304 can be attached together using means other than fasteners, e.g., by welding, adhesive, and the like.

[0202] Referring to FIG. 23, the handle 204 can further include a pull body 500 disposed distally to the gearbox 300 and releasably engaged with the fifth housing section/release housing 380 of the gearbox housing 304. The second knob 268 can rotatably engage the pull body 500 such that rotation of the second knob 268 relative to the handle body produces translation of the pull body 500 along the longitudinal axis LI of the handle. The pull body 500 can be coupled to the outer sleeves 244 of the actuation assemblies 220 such that translation of the pull body 500 along the longitudinal axis LI of the handle results in axial displacement of the outer sleeves 244 relative to the handle. This axial displacement can be used, for example, to axially displace the outer sleeves 244 relative to the corresponding actuator drivers 248 and thereby release the actuator drivers 248 from the prosthetic heart valve.

[0203] Referring to FIGS. 24A-24D, the pull body 500 has an axial axis L3 that is parallel to the longitudinal axis LI of the handle. The pull body 500 includes a first pull body member 504 having a plurality of elongate sockets 508 that are parallel to the axial axis L3 of the pull body 500. Each of the sockets 508 can receive an actuation tube 512 (only two sockets 508 receiving actuation tubes 512 are illustrated in FIGS. 24A-24C). The number of sockets 508 can match the number of actuation assemblies 220 of the delivery apparatus 200. For example, if the delivery apparatus 200 has six actuation assemblies 220, the pull body 500 can have six sockets 508. The sockets 508 are located on a side of the first pull body member 504 facing the gearbox 300.

[0204] The first pull body member 504 can include a pair of slider arms 516 extending in a direction parallel to the longitudinal axis LI of the handle (and parallel to the axial axis L3 of the pull body) and towards the gearbox 300. With respect to each other, the slider arms 516 are spaced apart in a direction transverse to the longitudinal axis LI of the handle (e.g., radially) and are in opposed relation. Each guide arm 516 terminates in a hooked end 522 having opposed stop surfaces 522a, 522b, which can be oriented transversely to the longitudinal axis Ll/axial axis L3. As illustrated in FIG. 24A, the slider arms 516 can be disposed in the respective guide slots 392 in the release housing 380 of the gearbox housing 304. Each slider arm 516 can move longitudinally within the respective guide slot 392 in a direction parallel to the longitudinal axis LI of the handle. The opposed stop surfaces 522a, 522b of the hooked end 522 of the slider arm 516 can engage the opposed stop surfaces 393, 394 of the respective guide slot 392 in order to limit travel of the slider arm 516 in the proximal direction or the distal direction. For example, when the stop surface 522a of the hooked end 522 abuts the stop surface 393, further movement of the slider arm 516 in the proximal direction is prevented (as depicted in FIG. 24F). Similarly, when the stop surface 522b of the hooked end 522 abuts the stop surface 394, further movement of the slider arm 516 in the distal direction is prevented (as depicted in FIG. 24E). The distance between the stop surfaces 393, 394 and/or the length of the slider arms 516 can be configured to allow the desired displacement of the pull body 500 and attached outer sleeves 244.

[0205] The first pull body member 504 can include a pair of guide beams 520 extending axially in a direction parallel to the longitudinal axis LI of the handle (and parallel to the axial axis L3 of the pull body 500). Relative to each other, the guide beams 520 are spaced apart in a direction transverse to the longitudinal axis LI of the handle (e.g., radially) and are in opposed relation. As illustrated in FIG. 24A, the guide beams 520 can be disposed in the respective guide channels 395 in the release housing 380 of the gearbox housing 304. Each guide beam 520 can move longitudinally within the respective guide channel 395 in a direction parallel to the longitudinal axis LI of the handle as the slider arms 516 move longitudinally within the respective guide slots 392.

[0206] The pull body 500 includes a second pull body member 524 disposed adjacent to the first pull body member 504 (e.g., distal in the depicted example). The second pull body member 524 can be attached to the first pull body member 504 by fasteners or other suitable method, such as welding, adhesive, and the like. In some instances, the first pull body member 504 and second pull body member can be formed (e.g., molded) as a single, unitary component. The second pull body member 524 includes a central hub 528 having a longitudinal axis that is aligned with the longitudinal axis L3 of the pull body 500. The second pull body member 524 includes a plurality of radial arms 532 extending from the central hub 528 to a periphery of the pull body 500. The radial arms 532 are angularly spaced about the axial axis L3 of the pull body 500, or angularly offset from each other. Each radial arm 532 comprises a pin 536 that 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, or angularly offset from each other, by virtue of the radial arms 532 being angularly spaced about the axial axis L3 of the pull body 500.

[0207] The second pull body member 524 has a plurality of openings 540 corresponding in number and position to the plurality of sockets 508 in the first pull body member 504. The actuation tube 512 can thereby extend into the sockets 508 through the openings 540. As further illustrated in FIG. 24D, each actuation tube 512 can have keys 542 (e.g., radial protrusions on the outer diameter of the actuation tube) that are received in slots 544 formed in the sockets 508 to prevent rotation of the actuation tube 512 within the sockets 508 (i.e., the actuation tubes 512 are rotationally fixed relative to the pull body 500).

[0208] As illustrated in FIGS. 24E and 24F, the first pull body member 504 and the second pull body member 524 have aligned openings 546, 547 to receive a guide rod 548. The guide rod 548 extends into an opening in the release housing 380 of the gearbox housing 304 and together with the slider arms 516 and guide beams 520 maintain longitudinal alignment of the pull body 500 with the gearbox 300 as the slider arms 516 move within the respective slots 392 in the release housing 380 of the gearbox housing 304.

[0209] As illustrated in FIGS. 24D and 24G, the outer sleeve 244 of each actuation assembly 200 extends into the lumen 513 of one of the actuation tubes 512 from the distal end of the actuation tube 512. The outer sleeve 244 is fixedly attached to the respective actuation tube 512 (e.g., using adhesive or set screws) so that the outer sleeve 244 can move when the pull body 500 moves. The actuator driver 248 associated with the outer sleeve 244 extends through the outer sleeve 244 to the release housing 380 of the gearbox housing 304. The actuator driver 248 can be secured to a coupling section 403 (e.g., as depicted in FIG. 18) mounted to the release housing 380 so as to couple the actuator driver 248 to the gearbox 300. In the example, the coupling section 403 is connected to a connector shaft 402, which can be coupled to a torque limiter 400. The torque limiter 400 is coupled to one of the output gears 344 of the gearbox 300. If the handle does not use torque limiters, the connector shaft 402 can be coupled directly to the respective output gear 344.

[0210] In one example, as shown in FIG. 24G, the outer sleeve 244 may not extend through the entire lumen 513 of the actuation tube 512. In this example, to provide support to the proximal end portion 512a of the actuation tube 512 that hangs out of the pull body 500, a support extension tube 552 can extend from the coupling section 403 into the portion of the lumen 513 of the actuation tube 512 not occupied by the outer sleeve 244. The support extension tube 552 can be fixedly attached to the coupling section 403 but slidable relative to the actuation tube 512 so that the actuation tube 512 can translate over the support extension tube 552 towards or away from the coupling section 403 as the slider arms 516 move along the slots 392 in the release housing 380 of the gearbox housing 304. In this example, each actuation driver 248 extends through the respective outer sleeve 244, through the portion of the lumen 513 of the actuation tube 512 between the outer sleeve 244 and the support extension tube 552, through the support extension tube 552, through the coupling section 403, into the connector shaft 402 (as depicted in FIG. 24G).

[0211] Referring to FIGS. 25A and 25B, the second knob 268 can have an inner surface 271 forming a cylindrical lumen 269. In the example, the cylindrical lumen 269 defines a central axis L6, which is oriented parallel to the longitudinal axis LI of the handle when the second knob 268 is mounted on the handle body (e.g., as depicted in FIGS. 8 and 23). Cam slots 270 are formed in the inner surface 271 of the second knob 268 that defines the lumen 269). The number of cam slots 270 can match the number of pins 536 of the pull body 500. The cam slots 270 can be rotationally offset from each other about the central axis L6 of the second knob 268 (e.g., for three cam slots 270, the center points of the cam slots 270 can be 120 degrees apart) such that when the second knob 268 is disposed around the pull body 500 (as illustrated in FIG. 23), each pin 536 can extend into a corresponding cam slot 270.

[0212] Referring to FIG. 25B, each cam slot 270 can have an angled portion 270a and lateral portions 270b, 270c at the opposite ends of the angled slot portion 270a. The angled slot portion 270a can extend along a path that is angled relative to the central axis L6. For example, the angled slot portion 270a can extend along a helical path. In one example, the path along which the angled slot portion 270a extends, or the inclination angle of the angle slot portion 270a relative to the central axis L6, can be configured such that movement of the pin 536 within and along the angled slot portion 270a produces movement of the pull body 500 in a direction parallel to the longitudinal axis LI of the handle (or the central axis L6 of the second knob 268). [0213] Each pin 536 can slide into the lateral slot portions 270b, 270c of the respective cam slot 270 upon reaching the end of a movement of the pull body 500 in a proximal direction or in a distal direction. As shown in FIGS. 4A, 8, and 23, the handle 204 can include a safety knob 276 that can slide into a slot in the second knob 268 to prevent the second knob 268 from being rotated relative to the handle body. The safety knob 276 can be used to restrict rotation of the second knob 268 relative to the body of the handle 204 and thereby prevent or reduce the likelihood of accidental release of the actuation assemblies 220 from the prosthetic heart valve 100. In one example, the second knob 268 can be configured such that the safety knob 276 can slide into the receiving slot in the second knob 268 when the pins 536 are in either of the lateral slot portions 270b, 270c. In some examples, the safety knob (which can also be called “a safety switch”) can be biased (e.g., with a biasing member such as a spring) toward the engaged/locked position with the second knob 268. When the safety knob 276 is removed from the receiving slot in the second knob 268 (e.g., by sliding the safety knob 276 distally), it will be possible to rotate the second knob 268 such that the pins 536 can be displaced into the angled slot portions 270a.

[0214] When the second knob 268 is rotated relative to the handle body, the pins 536 slide along the cam slots 270. As the pins 536 slide along the angled slot portions 270a of the cam slots 270, the pull body 500 is translated along the longitudinal axis LI of the handle. FIG. 7C shows the outer sleeves 244 engaged with the frame 104 of the prosthetic heart valve 100 and covering the flexible elongated elements 254 (shown in FIG. 7B) of the actuator drivers 248. To release the actuation assemblies 220 from the prosthetic heart valve 100 (e.g., after radially expanding the prosthetic heart valve 100 at the implantation location), the outer sleeves 244 need to be released from the frame 104 and also from covering the flexible elongated elements 254 of the actuator drivers 248. Both actions can be achieved by axially displacing the outer sleeves 244 relative to the handle. For example, the second knob 268 can be rotated in a direction to move the pull body 500 proximally (i.e., towards the gearbox 300). Since the outer sleeves 244 are attached to the pull body 500, the outer sleeves 244 are axially displaced in a direction along the longitudinal axis LI of the handle and towards the proximal end of the handle. The axial displacement of the outer sleeves 244 can retract the outer sleeves 244 from the frame 104 and from the flexible elongated elements 254, allowing the flexible elongated elements 254 (shown in FIGS. 7A-7B) of the actuator drivers 248 to be released from the actuator heads 176 of the prosthetic heart valve 100. [0215] During expansion of the prosthetic heart valve 100, rotational movement of the actuator drivers 248 by operation of the gearbox 300 applies a torque to the prosthetic heart valve 100 that tends to rotate the prosthetic heart valve about the longitudinal axis L of the prosthetic heart valve. Since the outer sleeves 244 are engaged with the frame 104 of the prosthetic heart valve 100, the outer sleeves 244 tend to rotate around the longitudinal axis L of the prosthetic heart valve 100. Since the pull body 500 is coupled to the outer sleeves 244, the pull body 500 likewise tends to rotate with the outer sleeves 244.

[0216] The gearbox 300 can pivot about the longitudinal axis LI of the handle, which is aligned with the axial axis of the input shaft 324 and the axial axis of the guide rod 548. Thus, rotation of the pull body 500 during expansion of the prosthetic heart valve 100 can result in pivoting of the gearbox 300 about the longitudinal axis LI of the handle 204. In some examples, the handle 204 includes a mechanism to limit pivoting of the gearbox 300 at least during expansion of the prosthetic heart valve 100. In one example, the mechanism can include a stop member that engages the gearbox housing 304 when the gearbox housing 304 is in a predetermined rotational position relative to the body of the handle 204.

[0217] Referring to FIGS. 21A, 21B, 22C-22E, the gearbox housing 304 can have an extension arm 356 projecting 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 surrounding the gearbox housing 304 (as shown in FIG. 21 A). In one example, the extension arm 356 can be a flat member lying in a plane transverse to the longitudinal axis LI of the handle. A protrusion member 360 can be attached to or integrally formed with the extension arm 356. The protrusion member 360 can be in the form of a rod or pin. The protrusion member 360 can have a rounded end 359 for contact with a stop member. The protrusion member 360 can be oriented in a direction transverse to the longitudinal axis LI of the handle. The extension arm 356 can position the protrusion member 360 such that an axial axis L4 (depicted in FIG. 22E) of the protrusion member 360 is tangential to a circular path 361 centered around the pivoting axis of the gearbox 300 (or longitudinal axis LI of the handle). This could also be described as the protrusion member 360 being radially outward of the pivoting axis of the gearbox 300. Thus, the protrusion member 360 moves along the circular path 361 as the gearbox 300 pivots. [0218] 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 could be an integral part of any of the other housing sections of the gearbox housing in other examples. Also, the extension arm 356 is shown at the top of the housing section 330. However, it could be located elsewhere on the housing section 330 provided that it positions the protrusion member 360 along the circular path 361. In some examples, the circular path can be larger or smaller than the circular path 361 so long as it is coaxial with the longitudinal axis LI of the handle.

[0219] A stop member 352 can be mounted to an inner surface of the proximal body portion 212 of the handle 204 (as depicted in FIG. 21A) such that the protrusion member 360 can contact the stop member 352 as the protrusion member 360 moves along the circular path 361. The stop member 352 can be positioned such that an axial axis L5 (shown in FIG. 22E) of the stop member 352 is also tangential to the circular path 361. Thus, as the protrusion member 360 moves along the circular path 361, the protrusion member 360 will encounter the stop member 352. In one example, the stop member 352 can be positioned such that when the first knob 264 (shown in FIG. 21 A) is rotated in a direction to expand the prosthetic heart valve (e.g., in the clockwise direction when viewing from the proximal end of the handle), the stop member 352 acts to limit the pivoting of the gearbox 300.

[0220] In one example, the first knob 264 can be rotated in a direction to expand the prosthetic heart valve 100 (e.g., in the clockwise direction when viewing from the proximal end of the handle). As the prosthetic heart valve 100 is expanded, if the protrusion member 360 is not yet in contact with the stop member 352, the entire gearbox 300 can pivot about the longitudinal axis LI of the handle (which is the same as the axial axis of the input shaft 324 as depicted in FIG. 21 A) in a direction towards the stop member 352. As the gearbox 300 pivots, the protrusion member 360 moves along the circular path 361 until the protrusion member 360 encounters the stop member 352, which then prevents further pivoting of the gearbox 300 in the same direction. While the protrusion member 360 is in contact with the stop member 352, the gear train 308 can still be operated through rotation of the first knob 264 and input shaft 324.

[0221] In one example, the stop member 352 can be a load cell (or force sensor) such that when the protrusion member 360 is in contact with the stop member 352 during expansion of the prosthetic heart valve (as depicted more clearly in FIG. 21B; the stop member 352 is shown in FIG. 2 IB without the handle body to which it is coupled for simplicity of illustration), any load applied to the stop member 352 by the protrusion member 360 can be measured. This measured load can be used to determine the torque applied to the prosthetic heart valve 100 during expansion of the valve. For example, the measured load can be multiplied by the moment arm as defined by the extension arm 356. Thus, the stop member 352 implemented with a load cell can perform the function of limiting pivoting of the gearbox 300 and measuring torque applied to the prosthetic heart valve 100. Load cells can be provided in dimensions that are significantly smaller than those of conventional torque meters, allowing a more compact handle design.

[0222] As the first knob 264 is rotated in a direction that compresses the prosthetic heart valve 100 (e.g., in the counterclockwise direction when viewing from the proximal end of the handle), the protrusion member 360 is spaced away from the stop member 352. As such, the stop member 352 does not act to limit pivoting of the gearbox 300 and does not measure torque when the prosthetic heart valve 100 is being compressed. In some cases, the handle body can act to limit pivoting of the gearbox 300 during compression of the prosthetic heart valve 100. For example, as illustrated in FIG. 26, the proximal body portion 212 of the handle 204 can include an inner protrusion 213 that engages the gearbox 300 when the gearbox 300 pivots in a direction R3 corresponding to compression of the prosthetic heart valve (e.g., the counterclockwise direction when viewed from the proximal end of the handle or the clockwise direction when viewed from the distal end of the handle). In some cases, the gearbox 300 can be provided with a second extension arm and protrusion member, and a second load cell (or a multi-directional load sensor) can be mounted on the handle body. The protrusion member on the second extension arm can be arranged to contact the second load cell to measure the torque applied to the prosthetic heart valve 100 while compressing the prosthetic heart valve.

[0223] The actuator drivers 248 are rotated by the gearbox 300, which can be operated by rotating the first knob 264. For example, the first knob 264 can be rotated in a direction that results in expansion of the prosthetic heart valve via the actuator drivers 248. In some cases, the actuator drivers 248 can spring back/recoil and slightly rotate in an opposite direction (e.g., counterclockwise) from the direction that the actuator drivers 248 were being rotated by the first knob 264 (e.g., clockwise). This can occur, for example, when the user releases or stops rotating the first knob 264. This spring back/recoil of the actuation drivers (e.g., the actuation drivers 248) can be referred to as “backlash.” Mechanisms are described below that can prevent the backlash of the actuator drivers 248 from being transferred to the first knob 264.

[0224] In some instances, the mechanisms that prevent transfer of backlash to the first knob can help the first knob stay in the same rotational position and not rotate back after the user stops rotating the knob or releases the knob. The mechanisms can thus help the user keep track of the number of rotations applied to the first knob, enable better reading of the rotational position of the first knob, and/or enable a more precise procedure.

[0225] In some instances, backlash of the first knob can result in a slight change in the expanded state of the prosthetic heart valve. For example, the prosthetic heart valve may have a first diameter (e.g., 29.2 mm) prior to the user releasing the actuation knob and have a second diameter which is slightly smaller (e.g., 29 mm) after the user releases the actuation knob and backlash occurs. The mechanisms that prevent transfer of backlash to the first knob can reduce a change in the expansion of the prosthetic heart valve when the user releases or stops rotating the first knob.

[0226] FIGS. 27-29 depict a backlash prevention mechanism, according to one example. The various components of the backlash prevention mechanism and their interaction with various other components of the delivery apparatus 200 are described below.

[0227] FIGS. 27 and 28A illustrate a support body 610, which can be a proximal end portion of the handle 204 (e.g., corresponding to proximal body portion 212 in FIGS. 4A and 8). A first knob 603 is rotatable relative to the support body 610 and coupled to the input shaft 324 of the gearbox 300 (the gearbox 300 is not shown in FIGS. 27 and 28A but can be seen within the cavity of the handle 204, for example, in FIG. 8).

[0228] A backlash prevention mechanism can, in some examples, include a pin 616 that couples the input shaft 324 to the first knob 603, as further described below. Referring to FIG. 27, the pin 616 is eccentric relative to a central longitudinal axis L7 of the first knob 603 and the longitudinal axis LI of the input shaft 324. In this manner, the pin 616 can transfer torque from the first knob 603 to the input shaft 324. The backlash prevention mechanism is also configured such that when backlash through the delivery apparatus via the input shaft 324 attempts to torque the first knob 603 (e.g., after the knob is released by the user), the first knob 603 can tilt relative to the input shaft 324 about the pin 616. In the tilted position, the first knob 603 is temporarily locked, thereby preventing the rotational position of the first knob 603 from changing when the user releases or stops rotating the first knob 603. The user can unlock the first knob 603 by grasping the first knob 603 and rotating the first knob 603 in a desired direction.

[0229] The first knob 603 with the backlash prevention mechanism can be used in place of the first knob 264 (depicted, for example, in FIG. 8). In the depicted example, the first knob 603 includes a head portion 600 and a shaft portion 602, which define the longitudinal axis L7. The head portion 600 can have a larger diameter compared to the shaft portion 602. The head portion 600 can be grasped by a user to rotate the first knob 603 relative to the support body 610 and can, in some examples, include surface features and textures to assist with gripping the knob.

[0230] The support body 610 includes a chamber 612 that is open at the proximal end of the handle 204. The chamber 612 can be in the form of a cylindrical bore, for example. The shaft portion 602 of the first knob 603 can be inserted into a proximal end portion of the chamber 612 of the support body 610.

[0231] In one example, the first knob 603 can comprise a shoulder 601 formed between the shaft portion 602 and the head portion 600. The shoulder 601 of the first knob 603 can touch the proximal end of the support body 610 when the shaft portion 602 of the first knob 603 is fully inserted into the chamber 612 of the support body 610. In this manner, the shoulder 601 can create a slight gap between the head portion 600 of the first knob 603 and the proximal end of the support body 610.

[0232] The shaft portion 602 of the first knob 603 can include a locking portion that can engage the inner wall of the chamber 612 when the shaft portion 602 is tilted within the chamber 612. For example, in some instances, the locking portion can comprise one or more annular protrusions extending radially outwardly from the shaft portion 602. In the depicted example, the locking portion includes a first annular protrusion 606 and a second annular protrusion 608. The annular protrusions 606, 608 are spaced axially relative to each other along the shaft portion 602. In the depicted example, the protrusions 606, 608 circumscribe the shaft portion 602. Additionally, or alternatively, the locking portion can comprise tabs that extend radially outwardly from the main portion of the shaft portion 602 but do not circumscribe the shaft portion 602.

[0233] The diameters dl, d2 of the shaft portion 602 at the protrusions 606, 608 can be slightly smaller than the inner diameter of the chamber 612 such that there are circumferential gaps gl, g2 between the protrusions 606, 608 and the wall 614 of the chamber 612. The circumferential gaps gl, g2 and the diameters dl, d2 can allow the shaft portion 602 to be freely rotatable within the chamber 612 and about the longitudinal axis L7 (e.g., when the first knob 603 is rotated during expansion or compression of the prosthetic heart valve) and to allow the first knob 603 to tilt about the pin 616. The diameters dl, d2 can be the same or different, as can be the gaps gl, g2.

[0234] The input shaft 324 can include a shaft portion 323 and a disc portion 325. The disc portion 325 can be disposed in a distal portion of the chamber 612 such that a proximal end face 325a of the disc portion 325 is in opposing relation to a distal end face 602a of the shaft portion 602 of the first knob 603. The shaft portion 323, which is attached to the disc portion 325, can extend through a distal opening 613 of the chamber 612 and into the cavity 205 of the handle 204. The shaft portion 323 is the portion of the input shaft 324 that can be coupled to the input gear 320 of the gearbox 300 (as depicted in FIG. 10B, for example).

[0235] The disc portion 325 can be positioned against a base surface 615 of the chamber 612 while being freely rotatable within the chamber 612 about the longitudinal axis LI of the input shaft 324/handle 204. The sum of the axial lengths of the disc portion 325 and the shaft portion 602 can be less than the axial length of the chamber 612 such that there is a gap 622 between the opposing end surfaces 325a, 602a of the disc portion 325 and the shaft portion 602. The gap 622 (together with the gaps gl, g2) can allow tilting of the shaft portion 602 within the chamber 612 and about the pin 616.

[0236] A first bore 618 is formed in the disc portion 325 of the input shaft 324. The first bore 618 can extend distally from the proximal end surface 325a of the disc portion 325. A distal end portion 616a of the pin 616 can be inserted into the first bore 618 and secured within the first bore using any suitable method (e.g., friction fitting, adhesive, welding, etc.). The first bore 618 is eccentric relative to the disc portion 325, which means that a central axis of the first bore 618 is radially (or laterally) offset from the longitudinal axis LI of the input shaft 324/disc portion 325 (as depicted by offset distance r2). [0237] A second bore 620 is formed in the shaft portion 602 of the first knob 603. The second bore 620 can extend proximally from the distal end surface 602a of the shaft portion 602 of the first knob 603. A proximal end portion 616b of the pin 616 can be received in the second bore 620. The second bore 620 is eccentric with the shaft portion 602, which means that a central axis of the second bore 620 is radially (or laterally) offset from the longitudinal axis L7 of the shaft portion 602/first knob 603 (as depicted by offset distance rl).

[0238] The first and second bores 618, 620 can be radially and circumferentially aligned (or rotationally aligned) so that the pin 616 can extend between the disc portion 325 and the shaft portion 602 and through the gap 622. The second bore 620 and the pin 616 are sized such that the pin 616 is slightly smaller than the second bore 620. This size difference can facilitate pivoting of the shaft portion 602 of the knob 603 on the distal end portion 616b of the pin 616.

[0239] The pin 616, with its end portions 616a, 616b received in the bores 618, 620, is eccentric to the disc portion 325 and to the shaft portion 602. In a first mode (see, e.g., FIG. 27), the eccentricity of the pin 616 allows rotation of the first knob 603 about the longitudinal axis L7 to be transferred to the input shaft 324 (the rotational force applied is proportional to the force applied to the pin 616 times the offset distance r2 of the pin from the center of the disc portion 325). Rotation of the first knob 603 results in tangential movement of the pin 616 (as depicted by arrow Y5 in FIG. 28B) along a circular path C2 (depicted in FIG. 28B) that is centered with the disc portion 325. The movement of the pin 616 results in rotation of the disc portion 325 in the same direction (as depicted by arrow Y6) about the longitudinal axis LI. In a second mode (see, e.g., FIG. 29), the eccentricity of the pin 616, the axial gap 622 between the shaft portion 602 and the disc portion 325, and the clearance between the distal end portion 616b of the pin 616 and the bore 620 allow movement of the pin 616 (as depicted by arrow Y7 in FIG. 28C) due to rotation of the disc portion 325 (as depicted by arrow Y8 in FIG. 28C) to tilt the shaft portion 602 within the chamber 612, relative to the input shaft 324 and about the pin 616.

[0240] When the first knob 603 is rotated in a first direction by a user, the rotational movement of the first knob 603 is translated, via the pin 616 and the input shaft 324, to the gearbox 300 and the actuator drivers 248 (the gearbox 300 and actuator drivers 248 are not shown in FIGS. 27 and 28A but can be seen in, for example, FIG. 12, where the knob 264 can be replaced with the first knob 603 with the backlash preventing mechanism). When the first knob 603 is released, the actuator drivers 248 can, in some instances, spring back in a second direction that is opposite to the first direction, thereby applying a rotational force to the disc portion 325 of the input shaft 324 in the second direction. This rotational force will result in tangential movement of the pin 616, due to the pin 616 being eccentric to the disc portion 325, which will cause the shaft portion 602 to tilt within the chamber 612, as shown in FIG. 29. Tilting of the shaft portion 602 causes the protrusions 606, 608 to be forcibly pressed against the chamber wall 614.

[0241] In the example illustrated in FIG. 29, the first protrusion 606 is pressed against a lower portion 614a of the chamber wall 614, and the second protrusion 608 is pressed against an upper portion 614b of the chamber wall 614 (i.e., the protrusions 606, 608 are pressed against opposite sides of the chamber wall 614). Thus, the first knob 603 is locked within the chamber 612 due to the frictional forces applied between the protrusions 606, 608 and the chamber wall 614. This in turn locks the pin 616, and consequently the entire gearbox 300 and the actuator drivers 248 coupled to the gearbox 300, in place, thus preventing backlash and a change in the diameter of the prosthetic heart valve.

[0242] The dimensions of the chamber 612 (e.g., axial length and inner diameter of the chamber), the dimensions of the protrusions 606, 608 (e.g., radial width and axial length of the protrusions), the size of the gaps gl, g2 between the protrusions 606, 608 and the chamber wall 614, and the coefficient of friction of the material of the protrusions 606, 608 can be designed to achieve the desired lock to prevent backlash while allowing the lock to be overcome when manual force is applied by the user to rotate the first knob 603.

[0243] FIGS. 30-31 depict another example of a backlash prevention mechanism. FIGS. 30 and 31 illustrate a knob assembly 650 coupled to a support body 652, which can be attached to, or integrated with, a proximal end portion of the handle 204 (as depicted in FIG. 34). The knob assembly 650 includes a first knob 654 that can be coupled to the input shaft 324 of the gearbox 300 within the handle 204 such that rotation of the first knob 654 operates the gearbox 300 (as depicted in FIG. 34).

[0244] The knob assembly 650 includes a mechanism that can prevent backlash when the first knob 654 is released (e.g., after using the first knob 654 to expand or compress the prosthetic valve). In one example, the mechanism includes a pin 696 coupled to the input shaft 324. The mechanism can further include a locker 656 disposed between the input shaft 324 and the first knob 654. The locker 656 can include a tiltable locker member (e.g., inner locker member 688) that can be tilted relative to the first knob 654 and the input shaft 324 and about the pin 696.

[0245] While the tiltable locker member (e.g., inner locker member 688) of the locker 656 is not tilted relative to the input shaft 324 and the first knob 654, the first knob 654 can be rotated in a first direction (which can be clockwise or counterclockwise depending on how the first knob 654 is configured to perform a desired operation, e.g., valve expansion or compression) relative to the support body 652. The rotation of the first knob 654 can be translated to movement of the pin 696 via the locker 656 (e.g., via the inner locker member 688). The movement of the pin 696 is configured to rotate the input shaft 324 about the longitudinal axis LI of the input shaft 324/handle 204, which results in operation of the gearbox 300 and rotation of the actuation drivers 248. When the first knob 654 is released, the actuator drivers 248 can spring back/recoil in a second direction (e.g., counterclockwise) that is opposite to the first direction (e.g., clockwise). This movement in the second direction is transferred to the input shaft 324 via the gearbox 300, which can result in rotation of the disc portion 325 of the input shaft 324 and movement of the pin 696 in the second direction. The tiltable locker member (e.g., inner locker member 688) of the locker 656 is configured to tilt in response to this second movement of the pin 696 such that further rotation of the input shaft 324 (and gearbox 300) in the second direction is prevented and such that movement of the pin 696 is not transferred to the first knob 654.

[0246] In the illustrated example, the support body 652 includes a chamber 661 that extends along a longitudinal axis of the support body 652. The chamber 661 has a first chamber portion 662 with an opening 666 at a proximal end 668 of the support body 652 and a second chamber portion 664 with an opening 670 at a distal end 672 of the support body 652. The support body 652 can have a guide extension 676 formed at the distal end 672. The guide extension 676 can include crossed slots 678 and 680. Slot 678 can be connected to the second chamber portion 664 through the opening 670.

[0247] The first knob 654 can be rotatably mounted to the support body 652. In one example, the first knob 654 can have a head portion 658 and a shaft portion 660. The head portion 658 can have a larger diameter compared to the shaft portion 660. The head portion 658 can be the portion of the first knob 654 that is held by a user in order to rotate the first knob 654 and can, in some examples, include surface features and/or textures to assist in gripping the knob. The shaft portion 660 can be inserted into the first chamber portion 662 through the opening 666. The diameter of the head portion 658 can be larger than the opening 666 such that the head portion 658 is disposed outside of the first chamber portion 662 and positioned adjacent to the proximal end 668 of the support body 652. In some cases, the head portion 658 can be offset from the proximal end 668 of the support body 652 to create a slight gap between the head portion 658 and the proximal end 668 of the support body 652.

[0248] The first knob 654 can be supported in the first chamber portion 662 such that a longitudinal axis L8 of the first knob 654/shaft portion 660 is aligned with the longitudinal axis LI of the input shaft 324/handle 204. In one example, the shaft portion 660 can include a protrusion 682 extending into a channel 684 formed in a wall of the first chamber portion 662 such that the first knob 654 is restrained from tilting within the first chamber portion 662 and relative to the input shaft 324. In the depicted example, the protrusion 682 is an annular protrusion extending radially outwardly from the shaft portion 660 and circumscribing the shaft portion 660. In another example, the protrusion 682 can comprise tabs that extend radially outwardly from the shaft portion 660 but do not circumscribe the shaft portion 660. There can be a clearance or gap between the protrusion 682 and the channel 684 that allows the protrusion 682 to move freely within the channel 684 when the first knob 654 is rotated relative to the support body 652.

[0249] The input shaft 324 can be rotatably mounted to the support body 652 (e.g., via the guide extension 676). In one example, the input shaft 324 can have a shaft portion 323 and a disc portion 325. The input gear 320 of the gearbox 300 can be attached to one end of the shaft portion 323, while the disc portion 325 is attached to the other end of the shaft portion 323. The disc portion 325 can be disposed in the slot 678 of the guide extension 676, with the shaft portion 323 extending through the slot 680. In some cases, the disc portion 325 can extend partly into the second chamber portion 664 through the opening 670 of the second chamber 664. The positioning of the disc portion 325 can be such that an end surface 325a of the disc portion 325 is in opposed relation to an end surface 660a of the shaft portion 660 of the first knob 654. [0250] First and second bores 702, 704 are formed in the shaft portion 660 of the first knob 654. The bores 702, 704 can extend proximally from the distal end surface 660a of the shaft portion 660. Distal end portions of knob pins 698, 700 can be inserted into the bores 702, 704 and secured within the bores 702, 704 using any suitable method (e.g., friction fitting, adhesive, welding, etc.). In one example, the bores 702, 704 are rotationally offset from each other. For example, the bores 702, 704 can be at diametrically opposed positions relative to the longitudinal axis L8 of the shaft portion 660/first knob 654. In one example, the bores 702, 704 are eccentric relative to the longitudinal axis L8 of the shaft portion 660/first knob 654 such that the knob pins 698, 700 are eccentric relative to the longitudinal axis L8 of the shaft portion 660/first knob 654. The knob pins 698, 700 can be used to couple the first knob 654 to the tiltable locker member of the locker 656.

[0251] A first bore 710 is formed in the disc portion 325 of the input shaft 324. The bore 710 can extend to the proximal end surface 325a of the disc portion 325. The pin 696 (which can also be referred to as disc pin 696 for convenience) can be inserted into the bore 710 and secured to the bore using any suitable method (e.g., friction fitting, adhesive, welding, and the like). In one example, the bore 710 is eccentric relative to the longitudinal axis LI of the disc portion 325/input shaft 324. The disc pin 696 can be used to couple the disc portion 325 to the tiltable locker member of the locker 656.

[0252] The locker 656 is disposed within the second chamber portion 664 and between the opposed end surfaces 325a, 660a (or between the input shaft 324 and the first knob 654). The locker 656 includes an outer locker member 686 and an inner locker member 688 (or tiltable locker member). The outer locker member 686 includes a chamber 694 in which the inner locker member 688 is located and within which the inner locker member 688 is tiltable. The outer locker member 686 is coupled to the support body 652. In one example, the outer locker member 686 can include a protrusion 690 extending radially outward from the outer locker member 686 into a channel 692 in the inner wall of the second chamber portion 664. The protrusion 690 can be an annular protrusion or can comprise tabs. The protrusion 690 and channel 692 can cooperate to restrain the outer locker member 686 from tilting within the second chamber portion 664.

[0253] First and second bores 706, 708 are formed in the inner locker member 688. The bore 706 can extend from the proximal end to the distal end of the inner locker member 688. The bore 708 can extend distally from the proximal end of the inner locker member 688. The bores 706, 708 can be rotationally offset and eccentric relative to a longitudinal axis L9 of the inner locker member 688. The configuration of the bores 706, 708 can be such that the bores 706, 708 of the inner locker member 688 can be longitudinally aligned with the bores 702, 704, respectively, of the shaft portion 660. For example, the rotational offset between the bores 706, 708 of the inner locker member 688 can be the same as the rotational offset between the bores 702, 704 of the shaft portion 660, and the eccentricities of the bores 706, 708 relative to the longitudinal axis L9 can be the same as the eccentricities of the bores 702, 704 relative to the longitudinal axis L8.

[0254] The disc portion 325 is coupled to the inner locker member 688 by extending a proximal end portion of the disc pin 696 into a distal portion of the bore 706 in the inner locker member 688. The shaft portion 660 of the first knob 654 is coupled to the inner locker member 688 by extending the distal end portions of the knob pins 698, 700 into respective proximal end portions of the bores 706, 708.

[0255] In one example, the inner locker member 688 includes a locking portion that can engage the inner wall of the chamber 694 when the inner locker member 688 is tilted within the chamber 694. In the depicted example, the locking portion includes an annular protrusion 712 extending radially outward from the inner locker member 688. The radial width of the annular protrusion 712 (i.e., a dimension in a direction transverse to the longitudinal axis L9 of the inner locker member 688) and the axial width of the annular protrusion 712 (measured in a direction parallel to the longitudinal axis L9 of the inner locker member 688) can be selected such that opposite corners 712a, 712b of the annular protrusion 712 engage the inner wall of the chamber 694 when the inner locker member 688 is sufficiently tilted (shown in FIG. 31).

[0256] When the inner locker member 688 is not tilted within the chamber 694, the longitudinal axis L9 of the inner locker member 688 can be aligned with the longitudinal axes LI, L8. In this position, when the first knob 654 is rotated in a first direction, the rotational movement of the first knob 654 is translated to tangential movement of the disc pin 696 via the knob pins 698, 700. The tangential movement of the disc pin 696 (depicted by arrow Y 1 in FIG. 33A) is translated to rotation of the disc portion 325 (depicted by arrow Y2 in FIG. 33A) of the input shaft 324, which then produces rotation of the actuator drivers 248 via the gearbox 300 (e.g., to expand or compress the prosthetic heart valve). The tangential movement is a movement along a circle Cl (depicted in FIG. 33 A) centered with the disc portion 325, where the radius of the circle Cl is defined by an offset of the pin 696 from the center of the disc portion 325.

[0257] When the first knob 654 is released, the actuator drivers 248 and gearbox 300 will tend to rotate in a second direction that is opposite to the first direction, thereby tending to rotate the disc portion 325 in the second direction (depicted as Y3 in FIG. 33B), which will result in tangential movement of the disc pin 696 in an opposite direction to which the disc pin 696 was previously moving (depicted by arrow Y4 in FIG. 33B). The second tangential movement of the disc pin 696, which is caused by movement of the disc portion 325, tilts the inner locker member 688 within the chamber 694 (i.e., the longitudinal axis L9 of the inner locker member 688 becomes inclined to the longitudinal axes LI, L8).

[0258] The inner locker member 688 can be tilted to engage the annular protrusion 712 with the inner wall of the chamber 694. As illustrated in FIG. 31, the lower corner 712b of the annular protrusion 712 is pressed against a lower portion of the chamber 694, resulting in an upward-oriented reaction force. The upper corner 712a of the annular protrusion 712 is pressed against an upper portion of the chamber 694, resulting in a downward-oriented reaction force. These forces wedge the inner locker member 688 within the chamber 694, temporarily preventing further rotation of the disc portion 325 and the gearbox 300/actuator drivers 248. However, subsequent rotation of the first knob 654 can release the inner locker member 688 from the wall of the chamber 694 such that rotation of the first knob 654 can again be translated to the disc pin 696 and eventually the gearbox 300/actuator drivers 248.

[0259] In one example, the inner locker member 688 can have a single annular protrusion 712 with an axial width sufficiently large to allow opposite corners of the annular projection 712 to engage opposite sides of the chamber 694. In another example, as illustrated in FIG. 32, the locking portion of the inner locker member 688 can include two annular protrusions 714, 716, spaced axially relative to each other along the inner locker member 688 (e.g., in a direction parallel to the longitudinal axis L9). In this case, when the inner locker member 688 is tilted, one of the annular protrusions (e.g., annular protrusion 714) can press against a lower side of the chamber 694 while the other annular protrusion (e.g., annular protrusion 716) presses against the upper side of the chamber 694. [0260] In the example illustrated in FIGS. 27-29, the gaps between the first knob 603 and the chamber wall 614 may result in rocking of the handle 204 during rotation of the first knob 603. In the examples illustrated in FIGS. 30-34, the first knob 654 is coupled to the support body 652 in a manner that does not allow the first knob 654 to tilt (e.g., by the protrusion 682 that extends into the channel 684). Thus, the inner locker member 688 can tilt to prevent backlash without tilting the first knob 654. Advantageously, the examples illustrated in FIGS. 30-34 can both prevent backlash due to release of the first knob 654 and avoid rocking of the handle 204 during rotation of the first knob 654.

[0261] In some examples, the gearbox 300 can be supported on the body of the handle 204. FIG. 35 illustrates an example where the gearbox 300 is mounted on a support shaft 800, for example, via a flange 804 provided on the gearbox housing 304. The support shaft 800 can extend proximally from the flange 804 and through openings in the proximal body portion 212 of the handle 204, thereby coupling the gearbox 300 to the handle body. In this example, if the input shaft 324 directly couples the first knob 264 to the gear train 308 (or if the input shaft 324 is a continuous shaft), the shaft can transfer lateral displacements (e.g., vibrations) to the gear train 308 along with torque from the first knob 264. The gear train 308 can in turn transfer the lateral displacements to the gearbox housing 304 and eventually to the handle body. In some examples, to allow torque to be transferred from the first knob to the gear train 308 while reducing other movement (e.g., lateral displacement, vibrations, etc.), a flexible coupling can be used to couple the first knob to the gear train 308.

[0262] Various types of flexible couplings can be used to couple the first knob to the gear train. For example, a “jaw and spider” type flexible coupling can be used, as further described below. In other examples, U joint, flexible torque cable, hypodermic needle tubing (or “hypotube”), or other flexible joint or method that can transmit torque without unwanted bending forces can be used to couple the first knob to the gear train.

[0263] FIGS. 36 and 37 illustrate an example of coupling the first knob 264 to the gear train 308 within the gearbox 300 using a flexible coupling 806, which is a jaw and spider type flexible coupling. In the example, the flexible coupling 806 includes a first flexible coupling member (e.g., a jaw coupling 812) and a second flexible coupling member (e.g., a spider coupling 814). A first shaft 808 has a proximal end portion that is coupled to the first knob 264. The jaw coupling 812 is coupled to a distal end portion of the first shaft 808 such that rotation of the first knob 264 rotates both the first shaft 808 and the jaw coupling 812. A second shaft 810 extends distally into the gearbox housing 304 and is coupled to the input gear 320 of the gear train 308. The spider coupling 814 is coupled to a proximal end portion of the shaft 810 disposed proximally to the gearbox housing 304. The jaw coupling 812 engages the spider coupling 814 to form the flexible coupling 806. The longitudinal axis LI of the handle can extend through the first shaft 808, the spider coupling 814, the jaw coupling 812, and the second shaft 810.

[0264] hi one example, the jaw coupling 812 of the flexible coupling 806 includes an end surface 818 that is transverse to the longitudinal axis LI. Protrusions 820 (or lugs) are formed on the end surface 818 (see, e.g., FIG. 38). The protrusions 820 extend distally away from the jaw coupling 812 in a direction parallel to the longitudinal axis LI. The protrusions 820 are angularly spaced about the longitudinal axis LI. In the example, four protrusions 820 are formed on the end surface 818 and are angularly spaced apart by 90 degrees relative to each other. In other examples, the jaw coupling 812 can have fewer or greater than four protrusions 820 with an appropriate angular spacing. In some examples, the protrusions can be equally spaced relative to each other (e.g., by 90 degrees, 120 degrees, 180 degrees, etc.). In other examples, the protrusions can be non-equally spaced relative to each other.

[0265] In one example, the spider coupling 814 of the flexible coupling 806 includes a plurality of protrusions 824 extending radially outwardly (see, e.g., FIG. 39) from a central hub portion. The protrusions 824 are angularly spaced apart about the longitudinal axis LI. The protrusions 824 define channels 826 between adjacent pairs of protrusions that are also angularly spaced apart about the longitudinal axis LI. The number of channels 826 of the spider coupling 814 can be equal to the number of protrusions 820 on the jaw coupling 812 such that each protrusion 820 of the jaw coupling 812 can mate with a corresponding channel 826 of the spider coupling 814. In one example, the angular spacing between the channels 826 can be the same as the angular spacing between the protrusions 820.

[0266] The flexible coupling 806 is formed by extending the protrusions 820 of the jaw coupling 812 into the corresponding channels 826 of the spider coupling 814 (as depicted in FIGS. 36, 37, and 40). The protrusions 820 and channels 826 allow relative lateral (which can also be referred to as “axial”) displacement between the jaw coupling 812 and the spider coupling 814 as torque is transferred across the flexible coupling 806. Thus, instead of transferring lateral displacements from the first knob 264 to the gear train 308 during rotation of the first knob 264, the flexible coupling 806 absorbs the lateral displacements.

[0267] The channels 826 can have curved walls (e.g., U shaped walls) along which the protrusions 820 can move. The protrusions 820 can have cylindrical shapes (as depicted in FIGS. 38 and 39) or more complex curved shapes depending on the profile of the channels 826. In general, the profiles of the channels 826 and protrusions 820 can be designed such that the protrusions 820 can move along the channels 826 in response to lateral displacements of the jaw coupling 812 and such that the protrusions 820 can be retained within the channels 826 while torque is transferred across the flexible coupling 806.

[0268] In some examples, the flexible coupling 806 can be used to couple a knob with a backlash preventing mechanism to the gear train. For example, FIG. 41 shows the flexible coupling 806 disposed between the knob assembly 650 (previously described with reference to FIGS. 30-32) and the gearbox 300. The spider coupling 814 is coupled to the gear train within the gearbox 300 as previously described. In this example, the first shaft 810 with the jaw coupling 812 is coupled to the knob 654 via the pins 696, 698, 700 and the inner locker member 688 that form part of the backlash preventing mechanism of the knob assembly 650.

[0269] Referring to FIGS. 1-41, the prosthetic heart valve 100 can be placed in a radially compressed configuration, and the actuation assemblies 220 of the delivery apparatus 200 can be releasably coupled to the actuators 168 of the prosthetic heart valve 100. The delivery apparatus 200 and the prosthetic heart valve 100 can be advanced over a guidewire through the vasculature of a patient to a selected implantation location (e.g., the native aortic annulus). For example, when implanting the prosthetic heart valve 100 within the native aortic valve, the delivery apparatus 200 and the prosthetic heart valve 100 can be inserted into and through a femoral artery, and through the aorta to the native aortic valve. The prosthetic heart valve 100 can then be deployed at the implantation location.

[0270] hi one example, the prosthetic heart valve 100 is enclosed in a delivery capsule 226 prior to insertion into the patient’s vasculature. In this case, the third knob 272 can be operated to retract the delivery capsule 226 and expose the prosthetic heart valve 100. To deploy the prosthetic heart valve 100, the physician can turn the first knob 264 (603, 654) to rotate the set of first actuator drivers (e.g., 248a, 248b, 248c) in a first direction and the set of second actuator drivers (e.g., 248d, 248e, 248f) in a second direction, corresponding to counter-rotation of the first and second sets of the actuators of the prosthetic heart valve 100 in a direction that radially expands the prosthetic heart valve 100. The actuator drivers can be rotated via a gear train. The first knob can be coupled to the gear train via a flexible coupling such that pure torque is transferred from the first knob to the gear train. The backlash prevention mechanism associated with the first knob 603, 654 can prevent backlash after the first knob is released.

[0271] During the valve expansion, the torque exerted on the native anatomy can be measured via the stop member/load cell 352 in the handle 204. During the valve expansion, torque limiter(s) 400 can stop the gearbox 300 if respective actuator driver(s) 248 become overloaded. After the prosthetic heart valve 100 has been expanded to the working diameter by rotation of the actuators, the actuation assemblies 220 can be released from the prosthetic heart valve 100. To release the actuation assemblies 220, the pull body 500 can be translated proximally along the longitudinal axis LI of the handle 204 (e.g., by rotating the second knob 268) so as to retract the outer sleeves 244 from the frame 104 of the prosthetic heart valve 100 and the flexible elongated elements 254 of the actuator drivers 248. The freed flexible elongated elements 254 can be removed from the actuator heads 176 of the prosthetic heart valve 100, allowing the delivery apparatus to be withdrawn from the body.

[0272] FIG. 42 illustrates an exemplary knob assembly 950 including a backlash prevention mechanism 952. The knob assembly 950 can be coupled to the proximal body portion 212 of the handle 204 (as depicted for the first knob 264 in FIGS. 4A and 8). The knob assembly 950 can include a first knob 954 having a longitudinal axis L9. The first knob 954 is rotatable relative to the proximal body portion 212 and about the longitudinal axis L9. The backlash mechanism 952 can couple the first knob 954 to the input shaft 324 of the gearbox 300 (the gearbox 300 is not shown in FIG. 42 but can be seen within the cavity of the handle 204, for example, in FIG. 8). The backlash mechanism 952 can transfer rotation of the first knob 954 to the input shaft 324 and prevent backlash of the first knob 954 when the first knob 954 is released.

[0273] In some examples, the backlash mechanism 952 includes a first rotatable knob member 956 that is attached to, or integrally formed with, the first knob 954 such that the first rotatable knob member 956 can rotate with the first knob 954 about the longitudinal axis L9. As illustrated in FIG. 42, in some examples, the first rotatable knob member 956 can be mounted within a distal portion of an inner chamber 958 of the first knob 954 and attached to the first knob 954 (for example, by fasteners, adhesive, etc.).

[0274] In some examples, the first rotatable knob member 956 includes a circumferential inner surface 960, a recessed annular surface 962, and a central opening 964. The recessed annular surface 962 is recessed relative to a proximal end of the first rotatable knob member 956. The central opening 964 is axially aligned with the longitudinal axis L9. In some examples, an outer edge 962a of the recessed annular surface 962 is connected to the circumferential inner surface 960, and an inner edge 962b of the recessed annular surface 962 is connected to (or adjacent to) the central opening 964.

[0275] In some examples, the backlash mechanism 952 includes a second rotatable knob member 966 that can be selectively rotatably coupled to the first rotatable knob member 956 as will be further described herein. The input shaft 324 is coupled to the second rotatable knob member 966 such that the input shaft 324 can rotate with the second rotatable knob member 966. For example, a distal end portion of the input shaft 324 can be received within a bore 968 of the second rotatable knob member 966 and fixed within the bore 968 (for example, by adhesive, set screws, etc.). When the second rotatable knob member 966 is rotatably coupled to the first rotatable knob member 956, rotation of the first knob 954 can be transferred to the input shaft 324 via the first rotatable knob member 956 and the second rotatable knob member 966.

[0276] hi some examples, the second rotatable knob member 966 extends through the central opening 964 of the first rotatable knob member 956 into the inner chamber 958 of the first knob 954. The second rotatable knob member 966 can include a radial flange 970 positioned adjacent to the recessed annular surface 962 of the first rotatable knob member 956. The radial flange 970 includes a circumferential outer surface 972 in opposing relation to and radially spaced from the circumferential inner surface 960 of the first rotatable knob member 956. The circumferential inner surface 960 and the circumferential outer surface 972 define an annular channel 974 between the first rotatable knob member 956 and the second rotatable knob member 966/radial flange 970.

[0277] In some examples, as shown more clearly in FIG. 43, the backlash mechanism 952 includes a set of release pins 978 protruding from an outer portion 962c of the recessed annular surface 962 that is adjacent to the circumferential inner surface 960. The set of release pins 978 can be integrally formed or otherwise attached to the first rotatable knob member 956. The set of release pins 978 extends into the annular channel 974 formed between the first rotatable knob member 956 and the radial flange 970. The set of release pins 978 can include one or more pins (six pins are shown for illustrative purposes). The release pins 978 are spaced around the circumferential outer surface 972 of the radial flange 970.

[0278] In some examples, the backlash mechanism 952 includes a set of driving pins 980 protruding from an inner portion 962d of the recessed annular surface 962 that is adjacent to the central opening 964 (shown in FIG. 42). The set of driving pins 980 can be integrally formed or otherwise attached to the first rotatable knob member 956. The set of driving pins 980 is positioned radially inward of the set of release pins 978 and can be concentric with the set of release pins 978. The driving pins 980 can be spaced in the same direction or different directions as of the release pins 978 (for example, in a circumferential direction around the central opening 964). Both sets of teeth 978, 980 circumscribe the longitudinal axis L9 (shown in FIG. 42). The set of driving pins 980 can include one or more pins (six pins are shown for illustrative purposes). The number of driving pins 980 can be the same as or can be different from the number of release pins 978.

[0279] The radial flange 970 is disposed adjacent to the inner portion 962d (shown in FIG. 42) of the recessed annular surface 962 and can abut the inner portion 962d of the recessed annular surface 962. As illustrated in FIG. 43, the radial flange 970 includes a set of openings 982 corresponding to and receiving the set of driving pins 980. In some examples, the openings 982 have spaces 984 around the set of driving pins 980 that allow play of the driving pins 980 within the corresponding openings 982. During rotation of the first rotatable knob member 956 relative to the second rotatable knob member 966, the driving pins 980 can move within the openings 982 in the rotational direction until the pins 980 engage the opposing edges of the openings 982. While the driving pins 980 are engaged with the edges of the openings 982, the driving pins 980 rotatably couple the first rotatable knob member 956 to the second inner knob member 968 and can transfer torque from the first rotatable knob member 956 to the second inner knob member 966.

[0280] In some examples, the backlash mechanism 952 includes one or more first biased movable members 986 disposed in the annular channel 974 (six first biased movable members are shown for illustrative purposes). One or more first biased movable members 986 can be positioned between two adjacent release pins 978, and the same or different number of first movable members 986 can be positioned between different sets of adjacent release pins 978. In the illustrated example, a first biased movable member 986 is positioned between each two adjacent release pins 978, forming an alternating arrangement of the release pins 978 and the first biased movable members 986. In some examples, each first biased movable member 986 can include a bias element 988 (for example, a spring) and two rolling elements 990a, 990b (for example, spherical beads, cylindrical rods, etc.) attached to the ends of the bias element 988. The bias element 988 extends between the rolling elements 990a, 990b and is configured to bias the rolling elements 990a, 990b away from each other (for example, towards adjacent release pins 978).

[0281] In some examples, the annular channel 974 has narrowed channel portions 992. In some examples, the narrowed channel portions 992 are formed by providing the circumferential inner surface 960 and the circumferential outer surface 972 forming the annular channel 974 with different shape profiles. In some examples, the circumferential inner surface 960 can have a cylindrical surface, and the circumferential outer surface 972 can have a polygonal surface (shown as a hexagonal surface for illustrative purposes, but not limited thereto). The narrowed channel portions 992 are formed towards the corners of the polygonal surface. The rolling elements 990a, 990b can be biased into the narrowed channel portions 992 to form releasable rotational locks that prevent spontaneous rotational movement of the first knob 954 (shown in FIG. 42) in either direction about the longitudinal axis L9. When the releasable rotational lock is formed, the first rotatable knob member 956 is not rotatably coupled to the second rotational knob member 966.

[0282] FIGS. 44A-47B illustrate a sequence of operations of the backlash mechanism 952. Initially, as shown in FIGS. 44A and 44B, first biased movable members 986 can form releasable rotational locks between the circumferential inner surface 960 of the first rotatable knob member 956 and the circumferential outer surface 972 of the second rotatable knob member 966 (for example, by biasing the rolling elements 990a, 990b into wedged positions in the narrowed channel portions 992 between the surfaces 960, 972).

[0283] When an operator rotates the first knob 954 in one direction, such as a clockwise direction as illustrated in FIG. 45A and 45B, the first rotatable knob member 956 rotates with the first knob 954. As the first rotatable knob member 956 rotates, the set of release pins 978 also rotates with the first rotatable knob member 956. An initial rotation (for example, about a fraction of a degree) causes the set of release pins 978 to contact the corresponding rolling elements 990a and release the rolling elements 990a from the wedged positions (or push the rolling elements 990a away from the wedged positions) in the narrowed channel portions 992.

[0284] Further rotation of the first knob 954 in the same direction, as illustrated in FIGS. 46A and 46B, causes each driving pin 980 to contact an edge of the respective opening 982, pushing the second rotatable knob member 966 in the direction of rotation. While pushing the second rotatable knob member 966 in the direction of rotation, the set of release pins 978 remains in contact with the leading rolling elements 990a and continues to push the rolling elements 990a in the same rotational direction, keeping the rolling elements 990a in released positions as long as the rotation continues. The rolling elements 990b remain in their wedged portions as the rolling elements 990a are pushed in the rotational direction.

[0285] The rotation of the second rotatable knob member 966 is translated to rotation of the input shaft 324, which can be transferred to rotation of the output shafts 346 of the gearbox 300 (see FIG. 10B) as previously described. The rotating output shafts 346 of the gearbox 300 rotate the actuator drivers 248 in a selected direction (for example, in a direction to facilitate expansion of the prosthetic heart valve via the actuators of the prosthetic heart valve). Once the operator releases the first knob 954, the first biased movable members 986 return to the free state where the rolling elements 990a, 990b are biased into their wedged positions in the narrowed channel portions 992. When the rolling elements 990a, 990b are in their wedged positions, while the input shaft 324 may tend to rotate in the opposite direction (for example, the counterclockwise direction) due to backlash, the second rotatable knob member 966 will be prevented from spontaneously rotating in this opposite direction due to the resistance conferred by the wedged rolling elements 990a, 990b, as illustrated in FIGS. 47A and 47B.

[0286] Returning to FIG. 42, in some examples, a third rotatable knob member 994 can be mounted within a proximal portion of the inner chamber 958 of the first knob 954 and proximal to the first rotatable knob member 956. In some cases, a proximal portion of the second rotatable knob member 966 can extend through a central opening 996 of the third rotatable knob member 994 into an inner chamber 998 of the third rotatable knob member 994. The second rotatable knob member 966 can be axially restrained by a proximal flange 993 that abuts an inner surface 993 of the third rotatable knob member 994 within the inner chamber 998 and a distal flange 995 that abuts an inner surface 997 of the proximal body portion 212.

[0287] In some examples, the third rotatable knob member 994 can be selectively rotatably coupled to the first knob 954 by one or more second biased movable members 977 (three second biased movable members 977 are shown in FIG. 43 for illustrative purposes) extending radially from the third rotatable knob member 994. In some examples, each second biased movable member 977 can include a bias element 979 (for example, a spring) and a rolling element 981 (for example, a spherical bead, cylindrical rod, etc.) attached to an end of the bias element 979. The second biased movable members 977 can be disposed in circumferentially spaced radial openings 983 in the third rotatable knob member 994. In some examples, each bias element 979 can be disposed in one of the radial openings 996 such that at least a portion of the rolling element 981 attached to the bias element 979 protrudes (for example, radially) from the third rotatable knob member 994.

[0288] In some examples, a circumferential inner surface 954a of the first knob 954 includes circumferentially spaced sockets 985 (shown more clearly in FIG. 43). Each socket 985 can receive a rolling element 981 of one of the second biased movable members 977 when radially aligned with the rolling element. The number of sockets 985 can be the same as or greater than the number of biased radial members 977. In FIG. 43, three second biased movable members 977 and twelve sockets 985 are shown for illustrative purposes. The angular spacing between the sockets 985 can be selected such that the rolling elements 981 can be simultaneously received in corresponding sockets 985. For example, N radial openings 983 angularly spaced m degrees apart and N rolling elements 981 protruding from the N radial openings 982, there can be one or more sets of N sockets 985 spaced m degrees apart to receive the N rolling elements 981 simultaneously.

[0289] In some examples, the bias elements 979 (shown in FIG. 42) of the second biased movable members 977 are stiffer than the bias elements 984 (shown in FIG. 43) of the first biased movable members 986. For example, the spring constant of each bias element 979 can be greater than the spring constant of each bias element 984. In some examples, the bias elements 979 are stiff enough such that during normal operation the bias elements 979 bias the rolling elements 981 into the sockets 985 in a manner that forces both the first knob 954 and the third rotatable knob member 994 to rotate simultaneously in the same direction.

[0290] In some examples, if a torque limiter locks the actuator drivers 248 (the actuator drivers 248 are not shown in FIGS. 42 and 43 but can be seen in, for example, FIG. 12, where the knob 264 can be replaced with the knob assembly 950) from further rotational movement in a selected direction (for example, when a torque on any of the actuation drivers 248 exceeds a threshold), continued rotation of the first knob 954 in the same direction overcomes the stiffness of the bias elements 979. With the stiffness of the bias member 979 overcome, the rolling elements 981 slide from one socket 985 to the next (and along the portion of the circumferential inner surface 954a between the sockets 985) such that continued rotation of the first knob 954 by the operator does not damage the backlash mechanism 952 while the actuator drivers 248 are locked.

[0291] FIGS. 48 and 49 illustrate an exemplary knob assembly 1050 including a backlash prevention mechanism 1052. The knob assembly 1050 can be coupled to the proximal body portion 212 of the handle 204 (as depicted for the first knob 264 in FIGS. 4A and 8). The knob assembly 1050 can include a first knob 1054 having a longitudinal axis L10. The first knob 1054 is rotatable relative to the proximal body portion 212 and about the longitudinal axis L10. The backlash mechanism 1052 can couple the first knob 1054 to the input shaft 324 of the gearbox 300 (the gearbox 300 is not shown in FIG. 48 but can be seen within the cavity of the handle 203, for example, in FIG. 8). The backlash mechanism 1052 can transfer rotation of the first knob 1054 to the input shaft 324 and prevent backlash of the first knob 1054 when the first knob 1054 is released.

[0292] In some examples, the backlash mechanism 1052 includes a first rotatable knob member 1056 that is attached to, or integrally formed with, the first knob 1054 such that the first rotatable knob member 1056 can rotate with the first knob 1054 about the longitudinal axis L10. The first rotatable knob member 1056 can be mounted within a distal portion of an inner chamber 1058 of the first knob 1054 and attached to the first knob 1054 using any suitable method (for example, by fasteners, adhesive, etc.).

[0293] In some examples, as shown more clearly in FIG. 49, the first rotatable knob member 1056 includes a central opening 1060 axially aligned with the longitudinal axis L10. The first rotatable knob member 1056 includes a circumferential inner wall 1062 circumscribing the central opening 1060 and a circumferential outer wall 1064 circumscribing and radially spaced from the circumferential inner wall 1062. A proximal end face of the circumferential inner wall 1062 includes a set of inner pins 1066 (shown in FIG. 48) angularly spaced about the longitudinal axis L10. The circumferential outer wall 1064 includes a set of outer pins 1068 (shown in FIG. 48) angularly spaced about the longitudinal axis L10. The set of outer pins 1068 are radially spaced from the set of inner pins 1066.

[0294] The backlash mechanism 1052 includes a second rotatable knob member 1070 attached to a distal end portion of the input shaft 324. For example, the second rotatable knob member 1070 can have a bore 1073 receiving the distal end portion of the input shaft 324. The distal end portion of the input shaft 324 can be secured within the bore 1073 using any suitable method (such as by set screws, adhesive, etc.). The second rotatable knob member 1070 extends through the central opening 1060 of the first rotatable knob member 1056 into a proximal portion of the inner chamber 1058 of the first knob 1054.

[0295] The second rotatable knob member 1070 includes a radial flange 1072 extending over the circumferential inner wall 1062 and circumferential outer wall 1064 of the first rotatable knob member 1056. The radial flange 1072 includes a set of inner slots 1074 (shown in FIG. 48) angularly spaced about the longitudinal axis L10. The set of inner slots 1074 are at a radial distance from the longitudinal axis L10 to receive the set of inner pins 1066. The radial flange 1072 includes a set of outer slots 1076 (shown in FIG. 48) that are radially spaced from the set of inner slots 1074 and angularly spaced about the longitudinal axis L10. The set of outer slots 1076 are at a radial distance from the longitudinal axis L10 to receive the set of outer pins 1068.

[0296] An inner rotational biasing member 1078 (for example, a torsion spring) is attached to the radial flange 1072. The inner rotational biasing member 1078 extends into a circumferential space 1080 between the circumferential inner wall 1062 and circumferential outer wall 1064 of the first rotatable knob member 1056. The inner rotational biasing member 1078 is wound around the circumferential inner wall 1062. An outer rotational biasing member 1082 (for example, a torsion spring) is attached to the radial flange 1072 and extends into a circumferential space 1081 around the circumferential outer wall 1064 of the first rotatable knob member 1056. The outer rotational biasing member 1082 is wound around the circumferential outer wall 1064.

[0297] The rotational biasing members 1078, 1082 are biased in opposite directions. For example, the outer rotational biasing member 1082 can be designed to resist counterclockwise rotational movement of the first knob 1054/first rotatable knob member 1056, while the inner rotational biasing member 1078 can be designed to resist clockwise rotational movement of the first knob 1054/first rotatable knob member 1056. In other examples, the outer rotational biasing member 1082 could resist clockwise rotational movement of the first knob 1054/first rotatable knob member 1056, while the inner rotational biasing member 1078 resists counter-clockwise rotational movement of the first knob 1054/first rotatable knob member 1056.

[0298] In some examples, the rotational biasing members 1078, 1082 include torsion springs having coil diameters that are slightly smaller than the diameters of the corresponding walls 1062, 1064 about which the rotational biasing members are wound. For example, the coil diameter of the torsion spring/inner rotational biasing member 1078 (in the free state) is smaller than the diameter of the circumferential inner wall 1062, and the coil diameter of the torsion spring/outer rotational biasing member 1082 (in the free state) is smaller than the diameter of the circumferential outer wall 1064. In the free state, the outer rotational biasing members 1078, 1082 are locked to the corresponding walls 1062, 1064 so as to prevent spontaneous rotation of the second rotatable knob member 1070 in either rotational direction. The rotational biasing members 1078, 1082 are released from the locked states by unwinding the rotational biasing members 1078, 1082 in opposite directions to their bias directions.

[0299] FIGS. 50A-52B illustrate sequential steps of counterclockwise rotational movement of the first knob 1054. In some examples, rotation of the input shaft 324 (shown in FIG. 49) in one direction (for example, the counter-clockwise direction) may serve to rotate the actuator drivers 248 (the actuators are not shown in FIGS. 50A-52B but can be seen in, for example, FIG. 12, where the knob 264 can be replaced with the knob assembly 1050) in a direction that facilitates expansion of the prosthetic heart valve, while rotation of the input shaft 324 in the opposite direction (for example, the clockwise direction) may serve to rotate the actuator drivers 248 in a direction that facilitates compression of the prosthetic heart valve. [0300] In the free-state position illustrated in FIGS. 50A and 50B, the outer rotational biasing member 1082 is biased to a locked position. The outer pins 1068 can be in the middle of the respective slots 1076, and the inner pins 1066 can be in the middle of the respective slots 1074, as shown in FIG. 50A. Initial rotation of the first knob 1054 in a counterclockwise direction, as shown in FIGS. 51A and 51B, from the locked position/free- state position (shown in FIGS. 50A and 50B) serves to release the outer rotational biasing member 1082 from its locked state. During this initial rotation, the outer pins 1068 move within the corresponding outer slots 1076 in the counterclockwise direction. However, as shown in FIGS. 50A and 50B, the outer pins 1068 do not reach the opposing edges 1076a (in the counterclockwise direction) of the outer slots 1076 during this initial rotation, which means that the first rotatable knob member 1056 is not yet rotatably coupled to the second rotatable knob member 1070. The extent to which the first knob 1054 is rotated to release the outer rotational biasing member 1082 from the locked state without engaging the second rotatable knob member 1070 can be suitably selected (for example, the initial rotation can be about 20 degrees).

[0301] The first knob 1054 can be further rotated in the counterclockwise direction until the outer pins 1068 contact the opposing edges 1076a of the respective outer slots 1076, as shown in FIGS. 52A and 52B. Once the outer pins 1068 contact the edges 1076a of the outer slots 1076, the second rotatable knob member 1070 is engaged. Additional rotation of the first knob 1054 will then force the second rotatable knob member 1070 to rotate. Since the input shaft 324 (shown in FIG. 49) is connected to the second rotatable knob member 1070, the input shaft 324 will rotate as well, which will result in rotation of the actuator drivers 248 via the gearbox 300 and, for example, expansion of the prosthetic heart valve. When the first knob 1054 is released, the outer rotational biasing member 1082 will return to its free state and locked position. Since the inner rotational biasing member 1078 is biased to resist clockwise rotational movement, according to the illustrated example, the inner rotational biasing member 1078 does not resist the counterclockwise rotation of the first knob 1054 during the sequence illustrated in FIGS. 50A-52B.

[0302] FIGS. 53A-55B illustrate sequential steps of clockwise rotational movement of the first knob 1054. In the free-state position illustrated in FIGS. 53A and 53B, the inner rotational biasing member 1078 is biased to a locked position. Initial rotation of the first knob 1054 in a clockwise direction, as shown in FIGS. 54A and 54B, from the locked position (as shown in FIGS. 53A and 53B) serves to release the inner rotational biasing member 1078 from its locked state. During this initial rotation, the inner pins 1066 move within the corresponding inner slots 1074. The first knob 1054 can be further rotated in the clockwise direction until the inner pins 1066 contact the opposing edges 1074a (in the rotational direction) of the inner slots 1074, as shown in FIGS. 55A and 55B. Once the inner pins 1066 contact the edges 1074a of the inner slots 1074, the second rotatable knob member 1070 is engaged. Additional rotation of the first knob 1054 will then force the second rotatable knob member 1070 to rotate in the clockwise direction. Since the input shaft 324 is connected to the second rotatable knob member 1070, the input shaft 324 will rotate as well, which will result in rotation of the actuator drivers 248 via the gearbox 300 and, for example, compression of the prosthetic heart valve. When the first knob 1054 is released, the inner rotational biasing member 1078 will return to its free state and locked position. Since the outer rotational biasing member 1082 is biased to resist counterclockwise rotational movement, according to the illustrated example, the outer rotational biasing member 1082 does not resist the clockwise rotation of the first knob 1054 during the sequence illustrated in FIGS. 53A-55B.

[0303] The backlash mechanism 1052 incorporating oppositely biased rotational biasing members 1078, 1082 prevents spontaneous rotation of the second rotatable knob member 1070. In some examples, only manual rotation of the first knob 1054 by the operator that releases a corresponding rotational biasing member 1078, 1082 from the locked state can cause rotation of the actuation drivers 248 in the desired direction.

[0304] Additional Examples

[0305] Additional examples based on principles described herein are enumerated below. Further examples falling within the scope of the subject can be configured by, for example, taking one feature of an example in isolation, taking more than one feature of an example in combination, or combining one or more features of one example with one or more features of one or more other examples.

[0306] Example 1 : A delivery apparatus for a prosthetic heart valve comprising a handle body; a shaft disposed within a cavity of the handle body, the shaft having a first longitudinal axis; a knob rotatably coupled to the handle body, the knob having a second longitudinal axis; and a pin coupling the shaft to the knob and eccentric relative to the first longitudinal axis and the second longitudinal axis; wherein a first movement of the pin due to rotation of the knob about the second longitudinal axis rotates the shaft about the first longitudinal axis; and wherein a second movement of the pin due to release of the knob tilts the knob relative to the shaft and about the pin.

[0307] Example 2: The delivery apparatus of any example herein, particularly Example 1, wherein the shaft is fixedly coupled to a first end portion of the pin, and wherein the knob is pivotably coupled to a second end portion of the pin.

[0308] Example 3: The delivery apparatus of any example herein, particularly any one of Examples 1-2, wherein a chamber is formed in an end portion of the handle body, wherein the knob comprises a shaft portion, and wherein the shaft portion extends into the chamber and is rotatably supported within the chamber.

[0309] Example 4: The delivery apparatus of any example herein, particularly Example 3, wherein the shaft portion comprises a locking portion configured to engage an inner wall of the chamber when the knob is tilted relative to the shaft and about the pin.

[0310] Example 5: The delivery apparatus of any example herein, particularly Example 4, wherein the locking portion comprises two annular protrusions extending radially from the shaft portion and axially spaced from each other in a direction parallel to the second longitudinal axis, and wherein the two annular protrusions engage opposite portions of the inner wall of the chamber when the knob is tilted relative to the shaft and about the pin.

[0311] Example 6: The delivery apparatus of any example herein, particularly Example 5, wherein a diameter of the shaft portion at each of the annular protrusions is less than a diameter of the inner wall of the chamber such that the shaft portion can rotate freely within the chamber.

[0312] Example 7: The delivery apparatus of any example herein, particularly any one of Examples 3 to 6, wherein the shaft comprises a disc portion disposed within the chamber, wherein the disc portion comprises a first end surface and the shaft portion comprises a second end surface, and wherein the first and second end surfaces are in opposing relation to each other within the chamber. [0313] Example 8: The delivery apparatus of any example herein, particularly Example 7, wherein the disc portion comprises a first bore connected to the first end surface, wherein the first bore is eccentric relative to the first longitudinal axis, and wherein the first end portion of the pin is received in the first bore.

[0314] Example 9: The delivery apparatus of any example herein, particularly Example 8, wherein the shaft portion comprises a second bore connected to the second end surface, wherein the second bore is eccentric relative to the second longitudinal axis, and wherein the second end portion of the pin is received in the second bore.

[0315] Example 10: The delivery apparatus of any example herein, particularly any one of Examples 7-9, wherein the pin extends through a gap between the first and second end surfaces.

[0316] Example 11: The delivery apparatus of any example herein, particularly any one of Examples 1-10, further comprising a gear train disposed within the cavity of the handle body, wherein the shaft is coupled to the gear train.

[0317] Example 12: The delivery apparatus of any example herein, particularly Example 11 , further comprising one or more actuator drivers coupled to the gear train.

[0318] Example 13: A handle for a delivery apparatus comprising: a shaft rotatably disposed about a first longitudinal axis; a knob rotatably disposed about a second longitudinal axis; and a pin eccentric to the first longitudinal axis and the second longitudinal axis; wherein the shaft is fixedly coupled to a first end portion of the pin and the knob is pivotable on a second end portion of the pin such that a first movement of the pin due to the rotation of the knob rotates the shaft and a second movement of the pin due to release of the knob tilts the knob relative to the shaft and about the second end portion of the pin.

[0319] Example 14: The handle of any example herein, particularly Example 13, further comprising one or more actuator drivers coupled to the shaft.

[0320] Example 15: The handle of any example herein, particularly Example 13, further comprising a gear train coupled to the shaft.

[0321] Example 16: The handle of any example herein, particularly Example 15, further comprising one or more actuator drivers coupled to the gear train. [0322] Example 17: A delivery assembly comprising: the delivery apparatus of any example herein, particularly any one of Examples 1-12 or the handle of any example herein, particularly any one of Examples 13-16; and a prosthetic heart valve releasably coupled to the handle or the delivery apparatus.

[0323] Example 18: The delivery assembly of any example herein, particularly Example 17, wherein the prosthetic heart valve comprises a mechanically expandable frame.

[0324] Example 19: A method of implanting a prosthetic heart valve comprising: engaging an actuator driver coupled to a shaft with an actuator coupled to a frame of the prosthetic heart valve; delivering the prosthetic heart valve to an implantation location; adjusting a diameter of the prosthetic heart valve by rotating a knob coupled to the shaft; and releasing the knob from rotation, wherein releasing the knob from rotation tilts the knob relative to the shaft to prevent backlash of the knob.

[0325] Example 20: A delivery apparatus for a prosthetic heart valve, the delivery apparatus comprising: a handle body; a shaft disposed within a cavity of the handle body, the shaft having a first longitudinal axis; a knob rotatably coupled to the handle body, the knob having a second longitudinal axis; a locker comprising a first locker member having a third longitudinal axis, the first locker member pivotally coupled to the knob; and a first pin coupling the shaft to the first locker member and eccentric relative to the first longitudinal axis and the third longitudinal axis; wherein a first movement of the first pin due to rotation of the knob rotates the shaft about the first longitudinal axis; and wherein a second movement of the first pin due to release of the knob from rotation tilts the first locker member relative to the shaft and about the first pin.

[0326] Example 21: The delivery apparatus of any example herein, particularly Example

20, further comprising two second pins coupling the knob to the first locker member, wherein the two second pins are rotationally offset from each other and are eccentric relative to the second longitudinal axis and the third longitudinal axis.

[0327] Example 22: The delivery apparatus of any example herein, particularly Example

21, wherein the shaft comprises a disc portion, and wherein a first end portion of the first pin is inserted into a first bore formed in the disc portion and a second end portion of the pin extends into a second bore formed in the first locker member. [0328] Example 23: The delivery apparatus of any example herein, particularly any one of Examples 21-22, wherein the knob comprises a shaft portion, wherein two second bores are formed in the shaft portion and two third bores are formed in the first locker member in positions corresponding to the two second bores formed in the shaft portion, and wherein first end portions of the two second pins are inserted into the two second bores and second end portions of the two second pins extend into the two third bores.

[0329] Example 24: The delivery apparatus of any example herein, particularly Example 23, wherein the two third bores are larger in diameter than the respective second end portions of the two second pins.

[0330] Example 25: The delivery apparatus of any example herein, particularly any one of Examples 23-24, further comprising a first chamber formed in an end portion of the handle body, wherein the shaft portion is received in a first portion of the first chamber.

[0331] Example 26: The delivery apparatus of any example herein, particularly Example

25, wherein a first portion of the first chamber comprises a first channel, wherein the shaft portion comprises a first protrusion that extends into the first channel, and wherein the first protrusion and the first channel restrain tilting of the second longitudinal axis relative to the first longitudinal axis when the third longitudinal axis is tilted relative to the first longitudinal axis by the second movement of the first pin.

[0332] Example 27: The delivery apparatus of any example herein, particularly Example

26, further comprising a second locker member received in a second portion of the first chamber, wherein the first locker member is disposed in a second chamber within the second locker member.

[0333] Example 28: The delivery apparatus of any example herein, particularly Example

27, wherein the second portion of the first chamber comprises a second channel, wherein the second locker member comprises a second protrusion that extends into the second channel, and wherein the second protrusion and the second channel restrain tilting of the second locker member when the third longitudinal axis is tilted relative to the first longitudinal axis by the second movement of the first pin.

[0334] Example 29: The delivery apparatus of any example herein, particularly any one of Examples 27-28, wherein the first locker member comprises a locking portion configured to engage an inner wall of the second chamber when the third longitudinal axis is tilted relative to the first longitudinal axis by the second movement of the first pin.

[0335] Example 30: The delivery apparatus of any example herein, particularly Example 29, wherein the locking portion comprises an annular protrusion extending radially from the first locker member, and wherein opposite comers of the annular protrusion engages the inner wall of the second chamber when the third longitudinal axis is tilted relative to the first longitudinal axis by the second movement of the first pin.

[0336] Example 31: The delivery apparatus of any example herein, particularly Example 29, wherein the locking portion comprises two annular protrusions extending radially from the first locker member and axially spaced from each other in a direction parallel to the third longitudinal axis, and wherein the two annular protrusions engage opposite portions of the inner wall of the second chamber when the third longitudinal axis is tilted relative to the first longitudinal axis by the second movement of the first pin.

[0337] Example 32: The delivery apparatus of any example herein, particularly any one of Examples 20-31, further comprising a gear train disposed within the handle body, wherein the shaft is coupled to the gear train.

[0338] Example 33: The delivery apparatus of any example herein, particularly Example 32, further comprising one or more actuator drivers coupled to the gear train.

[0339] Example 34: A handle for a delivery apparatus comprising: a shaft rotatably disposed about a first longitudinal axis; a knob rotatably disposed about a second longitudinal axis; a locker member having a third longitudinal axis and pivotably coupled to the knob; a first pin coupling the shaft to the locker member and eccentric relative to the first longitudinal axis and the third longitudinal axis; wherein a first movement of the first pin due to rotation of the knob rotates the shaft; and wherein a second movement of the first pin due to release of the knob from rotation tilts the locker member relative to the shaft and the knob and about the first pin.

[0340] Example 35: The handle of any example herein, particularly Example 34, further comprising a handle body having a chamber formed in an end portion thereof, wherein the knob comprises a shaft portion disposed in a first portion of the chamber, and wherein the locker member is disposed in a second portion of the chamber that is longitudinally displaced from the first portion of the chamber.

[0341] Example 36: The handle of any example herein, particularly Example 35, further comprising two second pins coupling the shaft portion to the locker member such that the second movement of the first pin tilts the locker member about the two second pins, wherein the two second pins are angularly spaced from each other and eccentric relative to the second longitudinal axis and the third longitudinal axis.

[0342] Example 37 : The handle of any example herein, particularly any one of Examples

35-36, wherein the shaft is fixedly coupled to a first end portion of the first pin, and wherein the locker member is pivotably mounted on a second end portion of the first pin.

[0343] Example 38: The handle of any example herein, particularly any one of Examples

36-37, wherein the knob is fixedly coupled to first end portions of the two second pins, wherein the locker member is pivotably mounted on second end portions of the two second pins, and wherein the knob is restrained from pivoting within the first portion of the chamber.

[0344] Example 39: The handle of any example herein, particularly any one of Examples 35-38, wherein the locker member comprises a locking portion configured to engage a surface within the chamber when the locker member is tilted relative to the shaft and the knob and about the first pin.

[0345] Example 40: The handle of any example herein, particularly any one of Examples 34-39, further comprising one or more actuator drivers coupled to the shaft.

[0346] Example 41 : The handle of any example herein, particularly any one of Examples 34-39, further comprising a gear train and one or more actuator drivers coupled to the gear train, wherein the shaft is coupled to an input gear of the gear train.

[0347] Example 42: A delivery assembly comprising: the delivery apparatus of any example herein, particularly any one of Examples 20-33 or the handle of any example herein, particularly any one of Examples 34-41; and a prosthetic heart valve releasably coupled to the handle or the delivery apparatus.

[0348] Example 43: The delivery assembly of any example herein, particularly Example 42, wherein the prosthetic heart valve comprises a mechanically expandable frame. [0349] Example 44: A method of implanting a prosthetic heart valve comprising: engaging an actuator driver coupled to a shaft of a handle with an actuator coupled to a frame of the prosthetic heart valve; delivering the prosthetic heart valve to an implantation location; adjusting a diameter of the prosthetic heart valve by rotating a knob coupled to the shaft by a locker member; and releasing the knob to stop adjustment of the diameter of the prosthetic heart valve, wherein releasing the knob tilts the locker member relative to the shaft and the knob to prevent backlash of the knob.

[0350] Example 45: A delivery apparatus for a prosthetic heart valve, the delivery apparatus comprising: a handle body; a gear train disposed within the handle body; a knob rotatably coupled to the handle body; and a flexible coupling disposed between the gear train and the knob and operatively coupling the knob to the gear train.

[0351] Example 46: The delivery apparatus of any example herein, particularly Example

45, further comprising a first shaft coupled to the knob and a second shaft coupled to the gear train, wherein the flexible coupling couples the first shaft to the second shaft.

[0352] Example 47: The delivery apparatus of any example herein, particularly Example

46, wherein the flexible coupling comprises a jaw coupling having axial protrusions and a spider coupling having radial openings, wherein the jaw coupling is mated with the spider coupling such that the axial protrusions extend into the radial openings.

[0353] Example 48: The delivery apparatus of any example herein, particularly Example

47, wherein the jaw coupling is coupled to the first shaft, and wherein the spider coupling is coupled to the second shaft.

[0354] Example 49: The delivery apparatus of any example herein, particularly any one of Examples 45-48, further comprising a gearbox housing coupled to the handle body, wherein the gear train is disposed within the gearbox housing.

[0355] Example 50: A delivery assembly comprising: the delivery apparatus of any example herein, particularly any one of Examples 45-49; and a prosthetic heart valve releasably coupled to the delivery apparatus.

[0356] Example 51 : A delivery apparatus for a prosthetic heart valve, the delivery apparatus comprising: a handle body having a cavity; a shaft disposed within the cavity; a knob having a longitudinal axis and rotatable relative to the handle body about the longitudinal axis; a first rotatable knob member fixedly coupled to the knob; a second rotatable knob member fixedly coupled to the shaft and rotatably coupled to the first rotatable knob member; and a first biased movable member disposed between the first rotatable knob member and the second rotatable knob member, the first biased movable member forming a first releasable rotational lock between the first rotatable knob member and the second rotatable knob member in a free state, wherein the first releasable rotational lock prevents spontaneous rotation of the knob in at least one of a first rotational direction and a second rotational direction that is opposite to the first rotational direction.

[0357] Example 52: The delivery apparatus of any example herein, particularly Example 51 , wherein a plurality of first biased movable members is disposed between the first rotatable knob member and the second rotatable knob member, wherein the plurality of first biased movable members forms a plurality of first releasable rotational locks between the first rotatable knob member and the second rotatable knob member in free states.

[0358] Example 53: The delivery apparatus of any example herein, particularly Example 51 , wherein the first rotatable knob member comprises a set of first pins disposed circumferentially around the second rotatable knob member, wherein the set of first pins is movable in a circumferential direction around the second rotatable knob member by rotation of the first rotatable knob member, and wherein the releasable rotational lock is released by contact of one pin of the set of first pins with the first biased movable member during movement of the set of first pins in the circumferential direction.

[0359] Example 54: The delivery apparatus of any example herein, particularly Example

53, wherein the first rotatable knob member comprises an inner surface, wherein the second rotatable knob member comprises an outer surface in opposing relation to the inner surface and radially spaced from the inner surface, wherein the inner surface and the outer surface define an annular channel extending around the second rotatable knob member and wherein the set of first pins extends into the annular channel.

[0360] Example 55: The delivery apparatus of any example herein, particularly Example

54, wherein the inner surface and the outer surface define a plurality of narrowed channel portions within the annular channel, and wherein the first biased movable member is biased to a wedged position in at least one of the narrowed channel portions to form the first releasable rotational lock. [0361] Example 56: The delivery apparatus of any example herein, particularly Example 55, wherein the inner surface is a cylindrical surface, and wherein the outer surface is a polygonal surface.

[0362] Example 57 : The delivery apparatus of any example herein, particularly any one of Examples 54-56, wherein the first biased movable member is disposed within the annular channel and between an adjacent pair of first pins.

[0363] Example 58: The delivery apparatus of any example herein, particularly Example

57, wherein the first biased movable member comprises a first bias element and two first rolling elements attached to opposite ends of the first bias element, and wherein the first bias element is configured to bias the two first rolling elements in opposite directions in the free state.

[0364] Example 59: The delivery apparatus of any example herein, particularly Example

58, wherein the first bias element biases the two first rolling elements into a pair of narrowed channel portions between the adjacent pair of first pins to form the first releasable rotational lock.

[0365] Example 60: The delivery apparatus of any example herein, particularly any one of Examples 53-59, wherein the first rotatable knob member further comprises a set of second pins radially inward of the set of first pins.

[0366] Example 61: The delivery apparatus of any example herein, particularly Example 60, wherein the second rotatable knob member comprises a set of openings receiving the set of second pins, and wherein the set of openings have spaces permitting movement of the set of second pins within the set of openings in the circumferential direction.

[0367] Example 62: The delivery apparatus of any example herein, particularly any one of Examples 60-61, wherein the first rotatable knob member comprises a recessed annular surface having a first edge connected to the inner surface and a second edge radially inward of the first edge, wherein the set of first pins protrudes from a first portion of the recessed annular surface adjacent to the first edge, and wherein the set of second pins protrudes from a second portion of the recessed annular surface adjacent to the second edge.

[0368] Example 63: The delivery apparatus of any example herein, particularly any one of Examples 51-62, further comprising: a third rotatable knob member disposed within an inner chamber of the knob; and a second biased movable member extending radially from the third rotatable knob member, the second biased movable member forming a second releasable rotational lock between the third rotatable knob member and the knob.

[0369] Example 64: The delivery apparatus of any example herein, particularly Example 63, wherein a stiffness of the second biased movable member is greater than a stiffness of the first biased movable member.

[0370] Example 65: The delivery apparatus of any example herein, particularly any one of Examples 63-64, wherein the knob comprises a plurality of sockets disposed circumferentially around the third rotatable knob member, and wherein the second biased movable member extends radially into one of the plurality of sockets to form the second releasable rotational lock.

[0371] Example 66: The delivery apparatus of any example herein, particularly any one of Examples 63-65, wherein the second biased movable member comprises a second bias element and a second rolling element attached to the second bias element, wherein the second bias element biases the second rolling element in an outward radial direction in the free state.

[0372] Example 67: The delivery apparatus of any example herein, particularly Example 66, wherein the third rotatable knob member comprises a radial opening receiving the second rolling element such that at least a portion of the second rolling element is disposed outside the radial opening in the free state.

103731 Example 68: The delivery apparatus of any example herein, particularly any one of Examples 63-67, further comprising a plurality of second biased movable members extending radially from the third rotatable knob member, the plurality of second biased movable members forming a plurality of second releasable rotational locks between the third rotatable knob member and the knob.

[0374] Example 69: The delivery apparatus of any example herein, particularly any one of Examples 51-68, further comprising a gearbox disposed within the cavity, wherein the shaft is coupled to the gearbox.

[0375] Example 70: The delivery apparatus according to any example herein, particularly Example 69, further comprising one or more actuator drivers coupled to the gearbox. [0376] Example 71 : A method of implanting a prosthetic heart valve, comprising: engaging an actuator driver with an actuator of a prosthetic heart valve, wherein the actuator driver is coupled to a shaft; rotating a knob in a first direction to release a biased movable member from forming a rotational lock between a first rotatable knob member coupled to the knob and a second rotatable knob member coupled to the shaft; after releasing the biased movable member form forming the rotational lock, further rotating the knob in the first direction to transfer torque to the shaft through the first rotatable knob member and the second rotatable knob member, wherein the torque transferred to the shaft causes the actuator driver to rotate the actuator and adjust a diameter of the prosthetic heart valve; and releasing the knob to stop adjustment of the diameter of the prosthetic heart valve, wherein releasing the knob returns the biased movable member to forming the rotational lock between the first rotatable knob member and the second rotational knob member.

[0377] Example 72: A delivery apparatus for a prosthetic heart valve, the delivery apparatus comprising: a handle body having a cavity; a shaft disposed within the cavity; a knob rotatable relative to the handle body about a longitudinal axis; a first rotatable knob member coupled to the knob and rotatable with the knob; a second rotatable knob member coupled to the shaft and rotatable with the shaft; a first rotational biasing member coupling the second rotatable knob member to the first rotatable knob member at a first position, the first rotational biasing member forming a first releasable rotational lock between the first rotatable knob member and the second rotatable knob member in a free state, wherein the first releasable rotational lock prevents spontaneous rotation of the knob in a first rotational direction.

[0378] Example 73: The delivery apparatus of any example herein, particularly Example 72, further comprising a second rotational biasing member coupling the second rotatable knob member to the first rotatable knob member at a second position and forming a second releasable rotational lock between the first rotatable knob member and the second rotatable knob member in a free state, wherein the second releasable rotational lock prevents spontaneous rotation of the knob in a second rotational direction that is opposite to the first rotational direction.

[0379] Example 74: The delivery apparatus of any example herein, particularly Example 73, wherein the first rotatable knob member comprises a set of first pins angularly spaced

- T1 - about the longitudinal axis, wherein the second rotatable knob member comprises a set of first slots receiving the set of first pins, and wherein the set of first pins are movable within the set of first slots by rotation of the first rotatable knob member in the first direction.

[0380] Example 75: The delivery apparatus of any example herein, particularly Example

74, wherein the first rotatable knob member comprises a set of second pins angularly spaced about the longitudinal axis, wherein the second rotatable knob member comprises a set of second slots receiving the set of second pins, and wherein the set of second pins are movable within the set of second slots by rotation of the first rotatable knob member in the second direction.

[0381] Example 76: The delivery apparatus of any example herein, particularly Example

75, wherein the set of second pins are disposed radially inward of the set of first pins.

[0382] Example 77: The delivery apparatus any example herein, particularly any one of Examples 73-76, wherein the first rotational knob member comprises a first circumferential wall, and wherein the first rotational biasing member is disposed around the first circumferential wall.

[0383] Example 78: The delivery apparatus of any example herein, particularly Example

77, wherein the first rotational knob member comprises a first torsion spring wound around the first circumferential wall and configured to resist rotational movement of the knob in the first rotational direction.

103841 Example 79: The delivery apparatus of any example herein, particularly Example

78, wherein a diameter of the first torsion spring in the free state is smaller than a diameter of the first circumferential wall.

[0385] Example 80: The delivery apparatus of any example herein, particularly any one of Examples 77-79, wherein the first rotational knob member comprises a second circumferential wall, and wherein the second rotational biasing member is disposed around the second circumferential wall.

[0386] Example 81: The delivery apparatus of any example herein, particularly Example 80, wherein the second circumferential wall is radially inward of the first circumferential wall. [0387] Example 82: The delivery apparatus of any example herein, particularly any one of Examples 80-81, wherein the second rotational knob member comprises a second torsion spring wound around the second circumferential wall and configured to resist rotational movement of the knob in the second rotational direction.

[0388] Example 83: The delivery apparatus of any example herein, particularly Example 82, wherein a diameter of the second torsion spring in the free state is smaller than a diameter of the second circumferential wall.

[0389] Example 84: A method of implanting a prosthetic heart valve, comprising: engaging an actuator driver with an actuator of a prosthetic heart valve, wherein the actuator driver is coupled to a shaft; rotating a knob in a first direction to release a first rotational biasing member from forming a first rotational lock between a first rotatable knob member coupled to the knob and a second rotatable knob member coupled to the shaft that resists rotation of the knob in the first direction; after releasing the first rotational biasing member from forming the first rotational lock, further rotating the knob in the first direction to transfer torque to the shaft through the first rotatable knob member and the second rotatable knob member, wherein the torque transferred to the shaft causes the actuator driver to rotate the actuator and adjust a diameter of the prosthetic heart valve; and releasing the knob to stop adjustment of the diameter of the prosthetic heart valve, wherein releasing the knob returns the first rotational biasing member to forming the first rotational lock between the first rotatable knob member and the second rotatable knob member.

[0390] Example 85 : The method of any example herein, particularly Example 84, wherein rotating the knob in the first direction to release the first rotational biasing member from forming the first rotational lock comprises rotating the knob by a fraction of a degree.

[0391] Example 86: The method of any example herein, particularly any one of Examples 84-85, wherein rotating the knob in the first direction to release the first rotational biasing member from forming the first rotational lock comprises unwinding a first torsion spring configured to resist rotation of the knob in the first direction.

[0392] Example 87 : The method of any example herein, particularly any one of Examples 84-88, further comprising: rotating the knob in a second direction that is opposite to the first direction to release a second rotational biasing member from forming a second rotational lock between a first rotatable knob member coupled to the knob and a second rotatable knob member coupled to the shaft that resists rotation of the knob in the second direction; after releasing the second rotational biasing member from forming the second rotational lock, further rotating the knob in the second direction to transfer torque to the shaft through the first rotatable knob member and the second rotatable knob member, wherein the torque transferred to the shaft causes the actuator driver to rotate the actuator and adjust the diameter of the prosthetic heart valve; and releasing the knob to stop adjustment of the diameter of the prosthetic heart valve, wherein releasing the knob returns the second rotational biasing member to forming the second rotational lock between the first rotatable knob member and the second rotatable knob member.

[0393] Example 88: The method of any example herein, particularly Example 87, wherein rotating the knob in the second direction to release the second rotational biasing member from forming the second rotational lock comprises rotating the knob by a fraction of a degree.

[0394] Example 89: The method of any example herein, particularly any one of Examples 87-88, wherein rotating the knob in the second direction to release the second rotational biasing member from forming the second rotational lock comprises unwinding a second torsion spring configured to resist rotation of the knob in the second direction.

[0395] The subject matter has been described with a selection of implementations and examples, but these preferred implementations and examples are not to be taken as limiting the scope of the subject matter since many other implementations and examples are possible that fall within the scope of the subject matter. The scope of the claimed subject matter is defined by the claims.

Claims

1. A delivery apparatus for a prosthetic heart valve, the delivery apparatus comprising: a handle body; a shaft disposed within a cavity of the handle body, the shaft having a first longitudinal axis; a knob rotatably coupled to the handle body, the knob having a second longitudinal axis; and a pin coupling the shaft to the knob and eccentric relative to the first longitudinal axis and the second longitudinal axis; wherein a first movement of the pin due to rotation of the knob about the second longitudinal axis rotates the shaft about the first longitudinal axis; and wherein a second movement of the pin due to release of the knob tilts the knob relative to the shaft and about the pin.

2. The delivery apparatus of claim 1, wherein the shaft is fixedly coupled to a first end portion of the pin, and wherein the knob is pivotably coupled to a second end portion of the pin.

3. The delivery apparatus of claim 1 or claim 2, wherein a chamber is formed in an end portion of the handle body, wherein the knob comprises a shaft portion, and wherein the shaft portion extends into the chamber and is rotatably supported within the chamber.

4. The delivery apparatus of claim 3, wherein the shaft portion comprises a locking portion configured to engage an inner wall of the chamber when the knob is tilted relative to the shaft and about the pin.

5. The delivery apparatus of claim 4, wherein the locking portion comprises two annular protrusions extending radially from the shaft portion and axially spaced from each other in a direction parallel to the second longitudinal axis, and wherein the two annular protrusions engage opposite portions of the inner wall of the chamber when the knob is tilted relative to the shaft and about the pin.

6. The delivery apparatus of claim 5, wherein a diameter of the shaft portion at each of the annular protrusions is less than a diameter of the inner wall of the chamber such that the shaft portion can rotate freely within the chamber.

7. The delivery apparatus of any one of claims 3-6, wherein the shaft comprises a disc portion disposed within the chamber, wherein the disc portion comprises a first end surface and the shaft portion comprises a second end surface, and wherein the first and second end surfaces are in opposing relation to each other within the chamber.

8. The delivery apparatus of claim 7, wherein the disc portion comprises a first bore connected to the first end surface, wherein the first bore is eccentric relative to the first longitudinal axis, and wherein the first end portion of the pin is received in the first bore.

9. The delivery apparatus of claim 8, wherein the shaft portion comprises a second bore connected to the second end surface, wherein the second bore is eccentric relative to the second longitudinal axis, and wherein the second end portion of the pin is received in the second bore.

10. The delivery apparatus of any one of claims 7-9, wherein the pin extends through a gap between the first and second end surfaces.

11. A delivery apparatus for a prosthetic heart valve, the delivery apparatus comprising: a handle body; a gear train disposed within the handle body; a knob rotatably coupled to the handle body; and a flexible coupling disposed between the gear train and the knob and operatively coupling the knob to the gear train.

12. The delivery apparatus of claim 11, further comprising a first shaft coupled to the knob and a second shaft coupled to the gear train, wherein the flexible coupling couples the first shaft to the second shaft.

13. The delivery apparatus of claim 12, wherein the flexible coupling comprises a jaw coupling having axial protrusions and a spider coupling having radial openings, wherein the jaw coupling is mated with the spider coupling such that the axial protrusions extend into the radial openings.

14. The delivery apparatus of claim 13, wherein the jaw coupling is coupled to the first shaft, and wherein the spider coupling is coupled to the second shaft.

15. The delivery apparatus of any one of claims 11-14, further comprising a gearbox housing coupled to the handle body, wherein the gear train is disposed within the gearbox housing.

16. A delivery apparatus for a prosthetic heart valve, the delivery apparatus comprising: a handle body having a cavity; a shaft disposed within the cavity; a knob having a longitudinal axis and rotatable relative to the handle body about the longitudinal axis; a first rotatable knob member fixedly coupled to the knob; a second rotatable knob member fixedly coupled to the shaft and rotatably coupled to the first rotatable knob member; and a first biased movable member disposed between the first rotatable knob member and the second rotatable knob member, the first biased movable member forming a first releasable rotational lock between the first rotatable knob member and the second rotatable knob member in a free state, wherein the first releasable rotational lock prevents spontaneous rotation of the knob in at least one of a first rotational direction and a second rotational direction that is opposite to the first rotational direction.

17. The delivery apparatus of claim 16, wherein a plurality of first biased movable members is disposed between the first rotatable knob member and the second rotatable knob member, wherein the plurality of first biased movable members forms a plurality of first releasable rotational locks between the first rotatable knob member and the second rotatable knob member in free states.

18. The delivery apparatus of claim 16, wherein the first rotatable knob member comprises a set of first pins disposed circumferentially around the second rotatable knob member, wherein the set of first pins is movable in a circumferential direction around the second rotatable knob member by rotation of the first rotatable knob member, and wherein the releasable rotational lock is released by contact of one pin of the set of first pins with the first biased movable member during movement of the set of first pins in the circumferential direction.

19. The delivery apparatus of claim 18, wherein the first rotatable knob member comprises an inner surface, wherein the second rotatable knob member comprises an outer surface in opposing relation to the inner surface and radially spaced from the inner surface, wherein the inner surface and the outer surface define an annular channel extending around the second rotatable knob member and wherein the set of first pins extends into the annular channel.

20. The delivery apparatus of claim 19, wherein the inner surface and the outer surface define a plurality of narrowed channel portions within the annular channel, and wherein the first biased movable member is biased to a wedged position in at least one of the narrowed channel portions to form the first releasable rotational lock.

21. A method of implanting a prosthetic heart valve, comprising: engaging an actuator driver with an actuator of a prosthetic heart valve, wherein the actuator driver is coupled to a shaft; rotating a knob in a first direction to release a first rotational biasing member from forming a first rotational lock between a first rotatable knob member coupled to the knob and a second rotatable knob member coupled to the shaft that resists rotation of the knob in the first direction; after releasing the first rotational biasing member from forming the first rotational lock, further rotating the knob in the first direction to transfer torque to the shaft through the first rotatable knob member and the second rotatable knob member, wherein the torque transferred to the shaft causes the actuator driver to rotate the actuator and adjust a diameter of the prosthetic heart valve; and releasing the knob to stop adjustment of the diameter of the prosthetic heart valve, wherein releasing the knob returns the first rotational biasing member to forming the first rotational lock between the first rotatable knob member and the second rotatable knob member.