Delivery apparatus and methods for implanting prosthetic heart valves

Abstract

To provide prosthetic heart valves, delivery apparatus, and methods for implanting the prosthetic heart valves, which can reduce the difficulty and / or time needed to implant a prosthetic heart valve.SOLUTION: A delivery apparatus for implanting a prosthetic heart valve includes one or more shafts and a handle coupled to the one or more shafts. The handle comprises one or more knobs, one or more adjustment mechanisms, and / or one or more control mechanisms. The knobs are configured for actuating the one or more adjustment mechanisms and / or the one or more control mechanisms. The one or more adjustment mechanisms are configured for moving the shafts relative to each other and / or relative to the handle. The one or more control mechanisms are configured for limiting the direction of movement and / or the force applied to the one or more shafts.SELECTED DRAWING: Figure 39A

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Application No. 62 / 990,299, filed March 16, 2020, which is incorporated herein by reference.

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

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

[0004] In one particular example, the prosthetic heart valve may be crimped onto the distal end of a delivery device and advanced through the patient's vascular system (e.g., through the femoral artery and aorta) until it reaches an 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 heart valve is mounted, by activating a mechanical actuator that applies an expansive force to the prosthetic heart valve, or by deploying the prosthetic heart valve from a sheath of the delivery device so that it can self-expand to its functional size.

[0005] A prosthetic heart valve that relies on a mechanical actuator for expansion may be referred to as a "mechanically expandable" prosthetic heart valve. Mechanically expandable prosthetic heart valves may offer one or more advantages over self-expandable and balloon-expandable prosthetic heart valves. For example, mechanically expandable prosthetic heart valves may be expanded to a variety of diameters. Also, mechanically expandable prosthetic heart valves may be compressed after initial expansion (e.g., for repositioning and / or retrieval).

[0006] Despite these advantages, mechanically expandable prosthetic heart valves may present some challenges. For example, it may be difficult to control the forces applied to the prosthetic heart valve and / or the delivery device during the implantation procedure. These difficulties may be exacerbated when the delivery device is disposed in a tortuous path (e.g., the patient's vasculature, etc.). It may also be difficult to release the mechanically expandable prosthetic heart valve from the delivery device. Additionally, given the number of moving components to control, typical delivery devices may be difficult and / or time-consuming for a user to operate. Thus, there is a need for improved delivery devices and methods for implanting mechanically expandable prosthetic heart valves. [Prior art documents] [Patent documents]

[0007] [Patent Document 1] US Patent Publication No. 2018 / 0153689 [Patent Document 2] US Patent Publication No. 2018 / 0344456 [Patent Document 3] US Publication No. 2019 / 0060057 [Patent Document 4] U.S. Provisional Application No. 62 / 869,948 [Patent Document 5] US Patent Publication No. 2015 / 0135506 [Patent Document 6] US Patent Publication No. 2014 / 0296962 [Patent Document 7] U.S. Provisional Application No. 62 / 945,039 [Patent Document 8] U.S. Provisional Application No. 63 / 138,599 [Patent Document 9] U.S. Provisional Application No. 62 / 928,291 [Patent Document 10] U.S. Provisional Application No. 62 / 928,320 [Patent Document 11] U.S. Provisional Application No. 62 / 870,372 [Patent Document 12] U.S. Application No. 62 / 886,677 Summary of the Invention [Means for solving the problem]

[0008] Described herein are prosthetic heart valves, delivery devices, and methods for implanting prosthetic heart valves. The disclosed delivery devices and methods can, for example, reduce the difficulty and / or time required to implant a prosthetic heart valve. The disclosed delivery devices are relatively simple and easy to use and include various safety features that can help ensure that the prosthetic heart valve is safely and securely implanted.

[0009] In one representative example, a delivery device for implanting a prosthetic heart valve includes one or more shafts and a handle coupled to the one or more shafts. The handle includes one or more knobs, one or more adjustment mechanisms, and / or one or more control mechanisms. The one or more adjustment mechanisms are configured to move the shafts relative to each other and / or relative to the handle. The one or more control mechanisms are configured to limit the direction of movement and / or the force applied to the one or more shafts.

[0010] In another representative example, the delivery assembly includes a leading delivery device and a prosthetic heart valve, the prosthetic heart valve being capable of being coupled to the delivery device.

[0011] In another representative example, a method of implanting a prosthetic heart valve includes rotating a first knob on a handle of a delivery device to retract a first shaft of the delivery device relative to the prosthetic heart valve, rotating a second knob on the handle to adjust radial expansion of the prosthetic heart valve, and rotating a third knob on the handle to release the prosthetic heart valve from the delivery device.

[0012] In another representative example, an assembly for implanting a prosthetic heart valve includes a prosthetic heart valve configured to be moved between a compressed state and an expanded state, and a delivery device including one or more shafts and handles. The prosthetic heart valve is releasably coupled to at least one of the shafts of the delivery device. The handle is configured to position the prosthetic heart valve and to adjust the prosthetic heart valve between the compressed state and the expanded state.

[0013] In another representative example, a delivery device for implanting a prosthetic heart valve includes a first shaft, a second shaft extending through the first shaft, a third shaft extending through the second shaft, and a handle. The first shaft includes a distal end portion and a proximal end portion. The distal end portion of the first shaft includes a capsule, the capsule configured to receive the prosthetic heart valve in a radially compressed state. The second shaft includes a distal end portion and a proximal end portion. The distal end portion of the second shaft is configured to contact the prosthetic heart valve. The third shaft includes a distal end portion and a proximal end portion. The distal end portion of the third shaft is configured to be releasably coupled to the prosthetic heart valve. The handle includes a main portion and a first knob rotatably coupled to the main portion. The proximal end portions of the first shaft, the second shaft, and the third shaft are coupled to the main portion of the handle. The handle is configured such that rotating the first knob in a first direction relative to the main portion from a first rotational position to a second rotational position results in axial movement of the first shaft relative to the second shaft and the third shaft. The handle is further configured such that rotating the first knob in a first direction relative to the main portion from the second rotational position to the third rotational position results in axial movement of the first shaft and the second shaft relative to the third shaft.

[0014] In another representative example, a delivery device for implanting a prosthetic heart valve includes a first shaft having a first end portion and a second end portion, a second shaft extending through the first shaft and having a first end portion and a second end portion, a nosecone coupled to the first end portion of the second shaft, and a handle including a main portion and an adjustment mechanism. The second end portion of the first shaft is coupled to the main portion of the handle. The second end portion of the second shaft is coupled to the adjustment mechanism. The adjustment mechanism is configured such that axially moving the adjustment mechanism relative to the main portion results in axially moving the second shaft relative to the first shaft.

[0015] In another representative example, a delivery device for implanting a prosthetic heart valve includes a first shaft and a handle. The first shaft has a first end portion and a second end portion. The first end portion of the first shaft is configured to be releasably coupled to the prosthetic heart valve. The handle includes a main portion, a rotatable knob, and a locking mechanism. The rotatable knob is rotatably coupled to the main portion and to the second end portion of the first shaft. The locking mechanism is configured to limit relative rotational movement of the rotatable knob and the main portion.

[0016] In another representative example, a delivery device for a prosthetic heart valve includes a handle having a cavity, a plurality of actuation assemblies including a plurality of movable portions, a plate member disposed within the cavity, and a drive assembly operably coupled to the plate member. Each of the movable portions has a proximal end portion disposed within the cavity and a distal end portion disposed outside the cavity. The plate member is axially movable relative to the handle. The plate member has a first state and a second state, in the first state the plate member moves freely relative to the movable portions and in the second state the plate member engages the movable portions such that further axial movement of the plate member results in axial displacement of the movable portions. The drive assembly is operable to move the plate member axially relative to the handle.

[0017] In another representative example, a delivery assembly includes a preceding delivery device and a mechanically expandable prosthetic heart valve including a plurality of actuators, the movable portion of the actuation assembly being releasably coupled to the plurality of actuators.

[0018] In another representative example, the method includes the steps of inserting a distal end of a leading delivery assembly into the patient's vascular system; advancing the distal end of the delivery assembly through the patient's vascular system to position the prosthetic heart valve at a selected implantation location; disengaging a movable portion of the actuation assembly from an actuator of the prosthetic heart valve; axially moving a plate member relative to the handle to engage the movable portion of the actuation assembly; and pulling the plate member and the movable portion of the actuation assembly to retract the movable portion of the actuation assembly from the prosthetic heart valve.

[0019] In another representative example, a delivery device for a prosthetic heart valve includes a handle, an actuation assembly, a drive assembly, a first sensor member, and a second sensor member. The handle has a proximal end, a distal end, and a cavity extending from the proximal end to the distal end. The actuation assembly includes an actuation member and a sleeve member. The actuation member has a proximal end portion disposed within the cavity and a distal end portion disposed outside the cavity. The sleeve member is disposed about the distal end portion of the actuation member. The first sensor member is coupled to the actuation member and rotatable with the actuation member. The second sensor member is positioned to detect a change in rotational position of the first sensor member.

[0020] In another representative example, a delivery device for a prosthetic heart valve includes a handle, an actuation assembly, a drive assembly, an electrical circuit, and a current sensor. The handle has a proximal end, a distal end, and a cavity extending from the proximal end to the distal end. The actuation assembly includes an electrically conductive actuation member and a sleeve member. The electrically conductive actuation member has a proximal end portion disposed within the cavity and a distal end portion disposed outside the cavity. The sleeve member is disposed about the distal end portion of the electrically conductive actuation member. The drive assembly is coupled to the actuation member and the handle and is operable to rotate the actuation member from within the cavity. The electrical circuit has an electrical path including the handle and the electrically conductive actuation member, the electrical circuit having an open state and a closed state, the open state corresponding to the electrically conductive actuation member being engaged with the prosthetic heart valve and the closed state corresponding to the electrically conductive actuation member being disengaged from the prosthetic heart valve. The current sensor is coupled to the electrical circuit for detecting an electrical condition of the electrical circuit.

[0021] In another representative example, a delivery device for a prosthetic heart valve includes a handle, a first shaft, a second shaft, and a knob. The handle includes a proximal portion, a distal portion, and a longitudinal axis. The proximal portion and the distal portion are telescopically movable relative to one another along the longitudinal axis. The first shaft is coupled to the distal portion and has a first lumen. The second shaft extends through the first lumen and is coupled to the distal portion such that relative movement between the proximal portion and the distal portion results in axial movement of both the first shaft and the second shaft. The knob is coupled to the first shaft such that rotation of the knob moves the first shaft axially relative to the handle, independent of the second shaft.

[0022] In another representative example, a delivery device for a prosthetic heart valve includes a handle, a first movable component, a second movable component, a first shaft, a second shaft, and a knob. The handle includes an inner track. The first movable component is positioned along the inner track and is axially movable along the inner track. The first shaft has a proximal end and a distal end. The second movable component is positioned along the inner track and is axially movable along the inner track. The second shaft has a proximal end and a distal end. The proximal end of the first shaft is coupled to the first movable component and the proximal end of the second shaft is coupled to the second movable component. The knob is coupled to the first movable component and is rotatable to move the first movable component along the inner track. The first movable component is axially movable along the inner track between a first position and a second position, in which the first movable component is axially separated from the second movable component and movement of the first movable component along the inner track results in movement of only the first shaft, and in the second position the first movable component is engaged with the second movable component and movement of the first movable component results in movement of both the first shaft and the second shaft.

[0023] In another representative example, a delivery device for a prosthetic heart valve includes a handle, a first shaft, a second shaft, a third shaft, and a slider mechanism. The first shaft has a first end portion, a second end portion, and a first lumen extending from the first end portion to the second end portion. The first end portion of the first shaft is coupled to the handle. The second shaft has a first end portion, a second end portion, and one or more second lumens. The second shaft extends through the first shaft. The third shaft extends through one of the one or more second lumens. The slider mechanism is coupled to the handle and the third shaft and is operable to axially displace the third shaft relative to the handle.

[0024] In another representative example, a delivery device for a prosthetic heart valve includes a handle having a first portion and a second portion, the second portion being rotatable relative to the first portion. A receiver is formed in the second portion and is rotatable with the second portion of the handle. The delivery device further includes a shaft, the shaft having a first end portion, a second end portion, and one or more lumens. A plurality of actuating members extend through the one or more lumens of the shaft. The actuating members are rotatable by rotation of the receiver.

[0025] In another representative example, a delivery device for a prosthetic heart valve includes a handle, a slidable knob, a multi-lumen shaft, and a first shaft. The handle has a proximal portion, a distal portion, and a cavity extending from the proximal portion to the distal portion. The proximal portion includes a slot. The slidable knob is slidably engaged with the slot. The multi-lumen shaft has a proximal end portion, a distal end portion, and a plurality of first lumens. The proximal end portion of the multi-lumen shaft is disposed within the cavity. The first shaft extends through one of the first lumens. The first shaft has a proximal end portion and a distal end portion. The proximal end portion of the first shaft is coupled to the slidable knob. Movement of the slidable knob along the slot results in axial displacement of the first shaft relative to the handle.

[0026] In another representative example, a delivery device for a prosthetic heart valve includes a handle, a multi-lumen shaft, a plurality of actuating members, a recompression member, and a tension mechanism. The handle has a proximal portion, a distal portion, and a cavity extending from the proximal portion to the distal portion. The multi-lumen shaft has a proximal end portion, a distal end portion, and a plurality of first lumens. The proximal end portion of the multi-lumen shaft is disposed within the cavity. The plurality of actuating members extend through one or more of the first lumens. Each of the actuating members has a distal threaded head, a proximal actuating flexible portion, and an actuating torque transmission portion extending between the distal threaded head and the proximal actuating flexible portion. The recompression member extends through one of the first lumens. The tension mechanism is at least partially disposed within the cavity. The tension mechanism is coupled to the proximal actuating flexible portion and the recompression member. The tensioning force mechanism is operable to apply a tensioning force to the proximal actuation flexible portion in a first mode and to apply a tensioning force to the recompression member in a second mode.

[0027] The various innovations of the present disclosure may be used in combination or separately. This Summary is provided to introduce a selection of concepts in a simplified form, which 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 present disclosure will become more apparent from the following Detailed Description, the claims, and the accompanying drawings. [Brief description of the drawings]

[0028] [Figure 1] FIG. 1 is a perspective view of an exemplary delivery assembly including a delivery device coupled to a prosthetic heart valve. [Diagram 2] FIG. 1 is a perspective view of an exemplary prosthetic heart valve. [Figure 3A] FIG. 2 is a perspective view of a frame of a prosthetic heart valve, with the frame shown in a radially expanded configuration. [Figure 3B] FIG. 2 is a perspective view of a frame of a prosthetic heart valve, with the frame shown in a radially compressed configuration. [Figure 4A] FIG. 3 is a detailed view of the prosthetic heart valve shown in FIG. 2, illustrating an example of a rocker / actuator of the prosthetic heart valve. [Figure 4B] FIG. 4B is a cross-sectional view of the rocker / actuator shown in FIG. 4A. [Figure 5A] FIG. 1 is a side view of an exemplary implementation of a delivery device. [Figure 5B] 5B is a cross-sectional view of the delivery device of FIG. 5A taken along line 5B-5B as shown in FIG. 5A. [Figure 5C] 1A-1C are side views of an exemplary implementation of an actuation assembly of a delivery device. [Figure 5D] FIG. 5B is a cross-sectional view of a distal portion of the delivery device shown in FIG. 5A illustrating the nosecone attached to the nosecone shaft. [Figure 6A]13A-13D illustrate engagement of the actuation assembly of the delivery device from the rocker / actuator of the prosthetic heart valve. [Figure 6B] 13A-13D illustrate the release of the actuation assembly of the delivery device from the rocker / actuator of the prosthetic heart valve. [Figure 7A] 1 is a side view of a distal portion of a delivery assembly illustrating a recompression member looped around the prosthetic heart valve with the prosthetic heart valve in a radially expanded configuration; FIG. [Figure 7B] 7B is a side view of the distal portion of the delivery assembly shown in FIG. 7A after compressing the prosthetic heart valve with a recompression member. FIG. [Figure 8A] FIG. 13 is a side view of a distal portion of a delivery assembly with a prosthetic heart valve enclosed within an exemplary distal capsule of a delivery device. [Figure 8B] FIG. 13 is a side view of a distal portion of a delivery assembly with a prosthetic heart valve enclosed within another exemplary distal capsule of a delivery device. [Figure 8C] 8C illustrates the axial position of the prosthetic heart valve relative to the nose cone after the outer shaft of the delivery device has been retracted to remove the distal capsule shown in FIG. 8B from the prosthetic heart valve. [Figure 8D] 13 illustrates the axial position of the prosthetic heart valve relative to the nosecone after the outer shaft has been further retracted to expose the actuation assembly of the delivery device. [Figure 9A] FIG. 13 is a side view of an exemplary implementation of a delivery device with an additional shaft between the outer shaft and the multi-lumen shaft. [Figure 9B] 9B is a side view of a distal portion of a delivery assembly including the delivery device shown in FIG. 9A with the outer shaft and additional shaft in their respective extended positions. FIG. [Figure 9C] FIG. 9C illustrates the position of the outer shaft and additional shaft of FIG. 9B after a first stage of shaft retraction. [Figure 10A] 1A-1D illustrate stages in the delivery of a prosthetic heart valve to an implantation site. [Figure 10B] 1A-1D illustrate stages in the delivery of a prosthetic heart valve to an implantation site. [Figure 10C] 1A-1D illustrate stages in the delivery of a prosthetic heart valve to an implantation site. [Figure 10D] 1A-1D illustrate stages in the delivery of a prosthetic heart valve to an implantation site. [Figure 11] 1A-1C are elevational views of an exemplary implementation of a handle of a delivery device. [Figure 12A] 12A is a cross-sectional view of the handle shown in FIG. 11 taken along line 12A-12A as shown in FIG. 11. [Figure 12B] FIG. 12B is an enlarged view of the distal portion of the handle shown in FIG. 12A. [Figure 13] FIG. 12 is an elevational view of the handle of FIG. 11 with some components removed to expose a portion of the shaft displacement mechanism. [Figure 14A] 12 is a cross-sectional view of a portion of the handle shown in FIG. 11 illustrating a guide head with a fitting for a flushing port. [Figure 14B] 12 is a cross-sectional view of a portion of the handle shown in FIG. 11 illustrating a flushing port extending through the handle. [Figure 14C] 13A-13C illustrate alternative implementations of flushing paths in the handle. [Figure 15A] FIG. 12 is a cross-sectional view of a portion of the handle shown in FIG. [Figure 15B] FIG. 12 is a detail of a portion of the handle shown in FIG. 11 illustrating structure extending proximally from the multi-lumen shaft. [Figure 15C] FIG. 12 is a detail of a portion of the handle shown in FIG. 11 illustrating structure extending proximally from the multi-lumen shaft. [Figure 15D] FIG. 12 is a perspective view of the handle shown in FIG. 11 with some components removed to illustrate the actuation member and recompression member extending proximally into the handle. [Figure 16A] 1A-1C are elevational views of an exemplary implementation of an actuation assembly of a delivery device. [Figure 16B] FIG. 15B is a detailed view of area 16B shown in FIG. 15A. [Figure 17] FIG. 12 is a perspective view of the handle of FIG. 11 with some components removed to illustrate the valve expansion and recompression mechanism. [Figure 18] FIG. 12 is a perspective view of the handle of FIG. 11 with some components removed to further illustrate the valve expansion and recompression mechanism. [Figure 19] FIG. 19 is a simplified schematic diagram of the valve expansion and recompression mechanism shown in FIGS. 17 and 18. [Figure 20A] FIG. 13 is a perspective view of an exemplary implementation of a tensioning assembly included within the valve expansion and recompression mechanism. [Figure 20B] 13 is a perspective view of another exemplary implementation of a tensioning assembly included within the valve expansion and recompression mechanism. FIG. [Figure 21A] 1A-1C illustrate an example implementation of a force limiting mechanism. [Figure 21B] 1A-1C illustrate an example implementation of a force limiting mechanism. [Figure 21C] 21A-21B with an adjustable biasing assembly; [Figure 22A] FIG. 21D shows a detail of a portion of a handle including a force-limiting mechanism according to FIGS. 21A-21C. [Figure 22B] FIG. 21D shows a detail of a portion of a handle including a force-limiting mechanism according to FIGS. 21A-21C. [Figure 22C] FIG. 21D shows a detail of a portion of a handle including a force-limiting mechanism according to FIGS. 21A-21C. [Figure 23A] 14 illustrates another example implementation of a force limiting mechanism for a handle. [Figure 23B]14 illustrates another example implementation of a force limiting mechanism for a handle. [Figure 23C] 14 illustrates another example implementation of a force limiting mechanism for a handle. [Figure 23D] 14 illustrates another example implementation of a force limiting mechanism for a handle. [Figure 23E] 14 illustrates another example implementation of a force limiting mechanism for a handle. [Figure 23F] 14 illustrates another example implementation of a force limiting mechanism for a handle. [Figure 24A] 14 illustrates another example implementation of a force limiting mechanism for a handle. [Figure 24B] 14 illustrates another example implementation of a force limiting mechanism for a handle. [Figure 24C] 14 illustrates another example implementation of a force limiting mechanism for a handle. [Figure 25A] FIG. 13 shows details of a handle illustrating an exemplary implementation of a valve expansion limiting mechanism. [Figure 25B] FIG. 25B is a perspective view of a knob coupled to the valve expansion limiting mechanism of FIG. 25A. [Figure 25C] FIG. 25C is a perspective view of a component of the clicking mechanism coupled to the knob of FIG. 25B. [Figure 26A] 13 illustrates another implementation of a valve expansion limiting mechanism for a handle. [Figure 26B] 13 illustrates another implementation of a valve expansion limiting mechanism for a handle. [Figure 26C] 13 illustrates another implementation of a valve expansion limiting mechanism for a handle. [Figure 27A] FIG. 13 shows a portion of the handle illustrating the status indicator mechanism. [Figure 27B] FIG. 13 shows a portion of the handle illustrating the status indicator mechanism. [Figure 27C] FIG. 13 shows a portion of the handle illustrating the status indicator mechanism. [Figure 28A] FIG. 13 shows a portion of the handle illustrating the status indicator mechanism. [Figure 28B] FIG. 13 shows a portion of the handle illustrating the status indicator mechanism. [Figure 28C] FIG. 13 shows a portion of the handle illustrating the status indicator mechanism. [Figure 29A] FIG. 13 shows a detail of the handle illustrating the connection of the knob to the gear train. [Figure 29B] FIG. 29B shows details of the gear train shown in FIG. 29A. [Figure 30A] FIG. 13 shows details of the handle illustrating a ratchet mechanism configured to limit rotation of the knob in one direction. [Figure 30B] FIG. 13 shows details of the handle illustrating a ratchet mechanism configured to limit rotation of the knob in one direction. [Figure 31A] FIG. 1 illustrates a portion of a delivery device with a mechanism for pulling an actuation member, according to one example. [Figure 31B] FIG. 31B is a cross-sectional view of a portion of the delivery device shown in FIG. 31A. [Diagram 32] FIG. 31C is a simplified schematic diagram of a portion of the delivery device shown in FIGS. 31A and 31B. [Figure 33A] FIG. 33A is a cross-sectional view of a portion of the delivery device shown in FIG. 31A taken along line 33A-33A. [Figure 33B] FIG. 31C is an enlarged view of region 33B of FIG. 31B. [Figure 34A] FIG. 13 is a perspective view of a portion of a delivery device including a mechanism for pulling an actuation member, according to another example. [Figure 34B] FIG. 34B is a cross-sectional view of a portion of the delivery device shown in FIG. 34A. [Figure 34C]FIG. 34C is a cross-sectional view of a portion of the delivery device shown in FIG. 34B taken along line 34C-34C. [Fig. 34D] FIG. 34C is an enlarged view of region 34D of FIG. 34B. [Figure 35A] 1 illustrates a portion of a delivery device including a proximal actuation member pull mechanism and a proximal actuation member release mechanism. [Figure 35B] FIG. 13 is an end view of the release mechanism. [Figure 36A] 1 is a cross-sectional view of a portion of a delivery device including a displacement control mechanism. [Figure 36B] FIG. 36B is an end view of the gear assembly of the displacement control mechanism of FIG. 36A. [Figure 36C] FIG. 36B is an enlarged view of region 36C in FIG. 36A. [Figure 36D] FIG. 36B illustrates a portion of the delivery device of FIG. 36A with a release mechanism. [Figure 36E] FIG. 36E is a bottom view of a portion of the delivery device shown in FIG. 36D. [Figure 37A] FIG. 13 is a side view of a twisted multi-lumen shaft. [Figure 37B] FIG. 37B is a cross-sectional view of the twisted multi-lumen shaft taken along line 37B-37B as shown in FIG. 37A. [Figure 37C] FIG. 37C is a cross-sectional view of the twisted multi-lumen shaft taken along line 37C-37C as shown in FIG. 37A. [Figure 38A] FIG. 13 is a perspective view of a handle according to another implementation. [Figure 38B] FIG. 38B shows a detail of the handle of FIG. 38A illustrating the valve rotation mechanism. [Figure 38C] FIG. 38C is a side view of a distal end portion of a delivery device illustrating rotation of the valve by the valve rotation mechanism of FIG. 38B. [Figure 38D] FIG. 38D illustrates the rotational position of the rocker / actuator of the valve of FIG. 38C prior to rotation. [Figure 38E]FIG. 38D illustrates the rotational position of the rocker / actuator of the valve of FIG. 38C after rotation. [Figure 38F] FIG. 1 illustrates the clicking mechanism. [Figure 38G] FIG. 1 illustrates the clicking mechanism. [Figure 39A] FIG. 13 is a cross-sectional view of an assembly including a mechanism configured to control the release of actuating members from their respective rockers / actuators. [Figure 39B] FIG. 39B shows a cross-section of the assembly shown in FIG. 39A taken along line 39B-39B as shown in FIG. 39A. [Figure 39C] FIG. 39B is a plan view of the pull plate of the assembly shown in FIG. 39A. [Figure 40A] FIG. 13 illustrates an electrical mechanism configured to detect release of the actuating members from their respective rockers / actuators. [Figure 40B] FIG. 40B shows the actuating member of FIG. 40A being released from the rocker / actuator. [Figure 41A] FIG. 13 illustrates an electrical rotation counting mechanism configured to detect release of the actuating members from their respective rockers / actuators. [Figure 41B] FIG. 41B illustrates a cross-section of the actuation assembly taken along line 41B-41B as shown in FIG. 41A. [Diagram 42] 14A-14D illustrate a magnetic rotation counting mechanism configured to detect release of the actuating members from their respective rockers / actuators. [Diagram 43] FIG. 13 illustrates an optical rotation counting mechanism configured to detect release of the actuating members from their respective rockers / actuators. [Diagram 44] 12 is a detailed view of the handle of FIG. 11 illustrating the mechanism for displacing the nosecone shaft of the delivery device. [Figure 45A]13A-13D illustrate the use of nose cone shaft displacement to facilitate repositioning of a prosthetic heart valve during an implantation procedure. [Figure 45B] 13A-13D illustrate the use of nose cone shaft displacement to facilitate repositioning of a prosthetic heart valve during an implantation procedure. [Figure 45C] 13A-13D illustrate the use of nose cone shaft displacement to facilitate repositioning of a prosthetic heart valve during an implantation procedure. [Figure 46A] 13A-13D illustrate the use of nosecone shaft displacement to reduce the risk of valve migration during the implantation procedure. [Figure 46B] 13A-13D illustrate the use of nosecone shaft displacement to reduce the risk of valve migration during the implantation procedure. [Figure 46C] 13A-13D illustrate the use of nosecone shaft displacement to reduce the risk of valve migration during the implantation procedure. [Figure 46D] 13A-13D illustrate the use of nosecone shaft displacement to reduce the risk of valve migration during the implantation procedure. [Figure 46E] 13A-13D illustrate the use of nosecone shaft displacement to reduce the risk of valve migration during the implantation procedure. [Figure 47A] FIG. 13 is a perspective view of a handle of a delivery device according to another implementation. [Figure 47B] FIG. 13 is a perspective view of a handle of a delivery device according to another implementation. [Figure 47C] FIG. 13 is a perspective view of a handle of a delivery device according to another implementation. [Figure 48] FIG. 13 is a perspective view of a handle of a delivery device according to another implementation. [Figure 49A] FIG. 1 illustrates a two-stage shaft retraction mechanism. [Figure 49B] FIG. 1 illustrates a two-stage shaft retraction mechanism. [Figure 49C] FIG. 1 illustrates a two-stage shaft retraction mechanism. [Figure 49D]FIG. 1 illustrates a two-stage shaft retraction mechanism. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0029] General Considerations

[0030] For purposes of this description, certain aspects, advantages, and novel features of the disclosed examples are described herein. The disclosed methods, devices, and systems should not be construed as limiting in any way. Instead, the disclosure is directed to all novel and non-obvious features and aspects of the various disclosed examples, both alone and in various combinations and subcombinations with one another. The methods, devices, and systems are not limited to any particular aspect or feature or combination thereof, and the disclosed examples do not require that any one or more particular advantages be present or problems be solved.

[0031] Although some operations in the disclosed examples are described in a particular sequential order for convenient presentation, this style of description embraces rearrangements, unless a particular order is required by specific language described below. For example, operations described sequentially may be rearranged or performed simultaneously in some cases. Moreover, for simplicity, the accompanying figures may not show the various ways in which the disclosed methods may be used with other methods. Additionally, the description sometimes uses terms such as "providing" or "realizing" to describe the disclosed methods. These terms are high-level abstractions of actual operations that are performed. The actual operations that correspond to these terms may vary depending on the particular implementation and are readily discernible by those skilled in the art.

[0032] For brevity and continuity in the description, the same or similar reference characters may be used for the same or similar elements in different figures, and the description of an element in one figure shall be considered to be carried forward when that element appears in another figure with the same or similar reference characters. In some cases, the term "corresponding to" may be used to describe the correspondence between elements of different figures. In exemplary usage, when an element in a first figure is described as corresponding to another element in a second figure, the element in the first figure shall be considered to have the attributes of the other element in the second figure, and vice versa, unless otherwise stated.

[0033] The word "comprise" and its derivatives (e.g., "comprises" and "comprising") should be interpreted in an open, inclusive sense, i.e., "including, but not limited to." The singular forms "a," "an," "at least one," and "the" include plural referents unless the context indicates otherwise. The word "and / or," when used between the last two elements of a list of elements, means any one or more of the listed elements. The term "or" is generally used in its broadest sense, i.e., to mean "and / or," unless the context explicitly indicates otherwise.

[0034] As used herein, the term "proximal" refers to a location, direction, or portion of a device that is closer to the user and farther from the implantation site. As used herein, the term "distal" refers to a location, direction, or portion of a device that is farther from the user and closer to the implantation site. Thus, for example, proximal movement of a device is movement of the device away from the implantation site toward the user (e.g., out of the patient's body), while distal movement of a device is movement of the device away from the user toward the implantation site (e.g., into the patient's body). The terms "longitudinal" and "axial" refer to axes extending in the proximal and distal directions, unless expressly defined otherwise.

[0035] Introduction to the disclosed technology

[0036] Described herein are prosthetic heart valves, delivery devices, and methods for implanting the prosthetic heart valves. The disclosed delivery devices and methods may be used, for example, to implant mechanically expandable prosthetic heart valves.

[0037] In some examples, the delivery device can include a handle. The handle can be configured to manipulate the delivery device and / or the prosthetic heart valve, which is releasably coupled to the delivery device. In certain examples, the handle can include one or more knobs and / or actuators. For example, in certain examples, the handle can include three rotatable knobs. The first (e.g., distal) knob can be configured for bidirectional axial translation of the outer shaft with the distal capsule. The second (e.g., proximal) knob can be configured for both expansion and contraction of the valve. In some cases, the second knob can operate two rails simultaneously, and the actuation member and the recompression member can be simultaneously wrapped around the two rails in opposite directions. The third (e.g., middle) knob can be coupled to a gear train, which allows the actuation members to be simultaneously rotated about their central axes. In some examples, a slidable knob can also be provided that allows for bidirectional axial translation of a nosecone at the distal end of the delivery device.

[0038] The handle can further include one or more additional components. For example, the handle can include a tensioning assembly configured to apply a minimum tension to the actuation members and the recompression members. This can prevent or reduce slack formation in the handle. As another example, the handle can include an even force distribution mechanism configured to apply an even pulling force to each of the multiple actuation members. As another example, the handle can include a force limiting mechanism configured to limit the amount of force that can be applied to expand or compress the prosthetic heart valve.

[0039] As another example, the handle can include a ratchet mechanism configured to reduce the likelihood of unintentionally over-tightening the threaded head of the actuation member within the respective rack member of the prosthetic heart valve.

[0040] In some cases, one or more of the knobs of the handle may be rotated manually. Additionally or alternatively, one or more actuators (e.g., buttons, switches, circuitry, and / or software) may be used to actuate one or more automated mechanisms (e.g., electric motors) to move and / or assist in moving components of the handle, the delivery device, and / or a prosthetic heart valve coupled to the delivery device.

[0041] FIG. 1 illustrates an exemplary delivery assembly 10 including a delivery device 12 and a prosthetic valve 60. For clarity of illustration, FIG. 1 does not show all details of the prosthetic valve 60, and details of the exemplary prosthetic valve 60 may be found in FIG. 2. The delivery device 12 includes a handle 100 and a shaft assembly 11 coupled to the handle 100. The prosthetic valve 60 may be coupled to one of the shafts of the shaft assembly 11 and delivered to an implantation site within the patient's body by advancing the shaft assembly 11 through the patient's vasculature. The handle 100 includes controls and mechanisms for placing the prosthetic valve 60 at the implantation site.

[0042] The prosthetic valve 60 may be configured to replace a native heart valve (e.g., aortic, mitral, pulmonary, and / or tricuspid). The prosthetic valve 60 may be a mechanically expandable prosthetic heart valve, which may allow the prosthetic heart valve to be compressed for delivery through a patient's vascular system and then expanded at the implantation site. Examples of mechanically expandable prosthetic heart valves are disclosed in U.S. Patent Nos. 5,393, 5,433, 5,596, 6,741, 6,893, 7,971, 7,892, 8,971, 9 ...

[0043] FIG. 2 illustrates an exemplary prosthetic valve 60, which is mechanically expandable and can serve as a basis for describing the operation of the delivery device 12. However, the delivery device 12 is not limited to the example of the prosthetic valve 60 shown in FIG. 2. As illustrated by FIG. 2, the prosthetic valve 60 includes a frame 61 (or stent), one or more rockers / actuators 62 coupled to the frame 61, and a valve structure 63. The rockers / actuators 62 can be configured to move the frame 61 between a radially expanded configuration and a radially compressed configuration (or crimped state). In addition, the rockers / actuators 62 can lock the frame 61 in a desired radially expanded configuration. Three rockers / actuators 62 are shown in FIG. 2 for illustrative purposes. However, the prosthetic valve 60 can have fewer or more than three rockers / actuators 62 in other examples.

[0044] The valve structure 63 is mounted within and coupled to the frame 61 and controls the flow of blood through the frame 61 when the prosthetic valve 60 is implanted in a patient's anatomy. The valve structure 63 includes leaflets 71 that cycle between closed and open states during use of the valve. The leaflets 71 may be made of a flexible material. For example, the leaflets 71 may be made in whole or in part from a biological material, a biocompatible synthetic material, or other such material. Suitable biological materials can include, for example, bovine pericardium (as well as pericardium from other sources). The leaflets 71 may be arranged to form commissures 73 that may be mounted, for example, to the rocker / actuator 62 or the frame 61.

[0045] 3A and 3B, the frame 61 includes an inflow end 65, an outflow end 67, and a plurality of interconnected struts 69 arranged to form an annular shape. The terms "inflow" and "outflow" refer to the normal flow direction through the valve. The struts 69 can form a lattice-type pattern as shown, or in other cases, a different pattern. In one example, the struts 69 are pivotally connected to each other by hinges 75 (e.g., rivets, etc.). The struts 69 can pivot about the hinges 75 to move the frame 61 between a radially expanded configuration (shown in FIG. 3A) and a radially compressed configuration (shown in FIG. 3B). In an alternative implementation, the frame 61 can have struts connected together by compliant joints. An exemplary mechanically expandable frame with compliant joints is disclosed in U.S. Patent No. 5,399,233, which is incorporated herein by reference.

[0046] In one implementation, the rocker / actuators 62 are mounted to and circumferentially spaced about the inner surface of the frame 61. The rocker / actuators 62 can be operated to pivot the struts 69 about their respective hinges 75, thereby causing radial expansion or compression of the frame 61. A locking portion of the rocker / actuators 62 can allow the frame 61 to be held in a desired radially expanded configuration. In an alternative example, the rocker / actuators 62 can be integrally formed with the frame 61.

[0047] 4A and 4B illustrate an exemplary rocker / actuator 62. The actuating portion of the rocker / actuator 62 includes a rack member 68 and a housing member 64. The rack member 68 extends into the housing member 64 and is axially movable relative to the housing member 64. The rack member 68 is coupled to the frame 61 at a first location (e.g., at a hinge 75 near the inflow end 65, etc.). The housing member 64 is coupled to the frame 61 at a second location (e.g., at a hinge 75 near the outflow end 67, etc.). The first and second locations are such that the rack member 68 and the housing member 64 extend axially of the frame. Relative movement between the rack member 68 and the housing member 64 in the axial direction causes the struts 69 to pivot about their respective hinges 75, resulting in a radial expansion or radial compression of the frame 61. As an example, moving the rack member 68 in a direction toward the outflow end 67 (e.g., in a proximal direction) radially expands the frame 61, and moving the rack member 68 in a direction toward the inflow end 65 (e.g., in a distal direction) radially compresses the frame 61.

[0048] The rocker portion of the rocker / actuator 62 includes ratchet teeth 70 on the rack member 68 and a spring-loaded tooth or pawl 66 on the housing member 64. The pawl 66 engages the ratchet teeth 70 to form a ratchet type mechanism that limits relative movement between the rack member 68 and the housing member 64 to a particular direction. In one example, the ratchet type mechanism formed by the pawl 66 and the ratchet teeth 70 can allow the rack member 68 to move relative to the housing member 64 in a direction toward the outflow end 67, while preventing the rack member 68 from moving relative to the housing member 64 in a direction toward the inflow end 65. The ratchet type mechanism can be used to lock the frame / prosthetic heart valve in a desired expanded state.

[0049] Further details regarding rocker / actuators for prosthetic heart valves can be found in US Pat. No. 6,399,633, which is incorporated herein by reference.

[0050] 5A and 5B, the handle 100 and shaft assembly 11 extend between the proximal end 13 and the distal end 15 of the delivery device 12. The shaft assembly 11 includes an outer shaft 14 having a lumen 17 and a multi-lumen shaft 22 extending through the lumen 17. The delivery device 12 can include one or more actuation assemblies 32 that can engage with a rocker / actuator 62 (shown in FIGS. 4A and 4B) of the prosthetic valve 60 (shown in FIG. 2). Three actuation assemblies 32 are shown for illustrative purposes. However, the delivery device 12 can have any number of actuation assemblies 32 (e.g., between one and eighteen). The actuation assemblies 32 can be operated by one or more controls and mechanisms of the handle 100.

[0051] The actuation assemblies 32 extend distally from the multi-lumen shaft 22 through the lumens 23 of the multi-lumen shaft 22. The lumens 23 may be angularly spaced apart about a central axis of the multi-lumen shaft 22. Each actuation assembly 32 may include a sleeve member 34 and an actuation member 40 (see FIG. 5C). In some cases, a proximal end 33 of the sleeve member 34 may be coupled to the multi-lumen shaft 22 (e.g., by a sleeve coupler), while the actuation member 40 extends through each lumen 23 of the multi-lumen shaft 22 and through each sleeve member 34. A distal end portion of the actuation member 40 is formed as a threaded head 44 (see FIG. 5C).

[0052] 6A , each actuation assembly 32 may be connected to a respective rocker / actuator 62 of the prosthetic valve 60 by engaging a distal threaded head 44 of the actuation member 40 with a threaded bore 72 of a rack member 68 of the rocker / actuator 62 of the prosthetic valve 60. The distal threaded head 44 may be threaded into the threaded bore 72 such that the distal end 36 of the sleeve member 34 abuts the proximal end 65 of the housing member 64, which allows a force directed distally from the handle 100 of the delivery device to be applied through the sleeve member 34 to the housing member 64.

[0053] While the actuation member 40 is threadably engaged with the rack member 68, the handle 100 of the delivery device (shown in FIG. 5A ) can be operated to pull the actuation member 40 in a proximally oriented direction d1, causing the rack member 68 to move in the same direction. At the same time, a distally directed force is applied to the housing member 64 through the sleeve member 34, such that proximal movement of the housing member 64 is prevented or limited, resulting in relative axial movement between the rack member 68 and the housing member 64. The relative axial movement between the rack member 68 and the housing member 64 can be used to radially expand the prosthetic valve 60. After expanding the prosthetic valve 60, the actuation assembly 32 can be released from the rocker / actuator 62 by rotating the actuation member 40 (e.g., in a direction c1 as shown in FIG. 6B ) to disengage the distal threaded head 44 of the actuation member 40 from the threaded bore 72 of the rack member 68.

[0054] 5A and 5B, the shaft assembly 11 includes a nosecone shaft 56 that extends distally from the multi-lumen shaft 22 through the lumen 24 of the multi-lumen shaft 22. The lumen 24 may be radially centrally disposed within the multi-lumen shaft 22. The nosecone shaft 56 defines a guidewire lumen 57 for receiving a guidewire. Additionally, the nosecone shaft 56 defines a loading / unloading area for a prosthetic valve 60 (shown in FIG. 1).

[0055] The nosecone 50 is attached to the distal end of the nosecone shaft 56. As shown in FIG. 5D, the nosecone 50 has a central opening 51 for receiving a guidewire. The central opening 51 in the nosecone 50 is aligned with a guidewire lumen 57 in the nosecone shaft 56. During an implantation procedure, a guidewire may be initially inserted into the patient's vasculature. The proximal end of the guidewire may be inserted into the central opening 51 of the nosecone 50 such that the delivery device 12 may be advanced over the guidewire through the patient's vasculature to the implantation site. As the delivery device 12 is advanced through the patient's vasculature, the guidewire passes through the nosecone 50 and into the nosecone shaft 56.

[0056] 5A and 5B, the shaft assembly 11 can include a recompression shaft 80 that extends distally from the multi-lumen shaft 22 through a lumen 25 of the multi-lumen shaft 22. In one example, the lumen 25 is disposed radially outwardly from the centrally disposed lumen 24. A recompression member 82 extends through a lumen 81 of the recompression shaft 80 and forms a loop 84 that extends distally from the recompression shaft 80. The recompression member 82 can be a wire, cable, suture, or other material that can be formed into a loop. The recompression member 82 can be used to recompress the prosthetic heart valve after an initial expansion of the prosthetic heart valve.

[0057] 7A shows the prosthetic valve 60 disposed about the nosecone shaft 56 and in an expanded state. A loop 84 extends around the prosthetic valve 60 in a lasso-like fashion. The prosthetic valve 60 may be recompressed by pulling the recompression member 82 proximally (as indicated by arrow 83) through the lumen of the recompression shaft 80 to apply tension to the loop 84, which results in contraction of the prosthetic valve 60, as shown in FIG. 7B. In another example, the loop 84 may extend around or between the sleeves 40 of the actuation assembly 32 and may be similarly tensioned to contract the prosthetic valve 60, as further described in U.S. Patent No. 6,399,326, which is incorporated herein by reference.

[0058] Returning to FIG. 5A, the distal capsule 16 is attached to the outer shaft 14. The distal capsule 16 may be integrally formed with the outer shaft 14 or may be a separate member attached to the outer shaft 14. The distal capsule 16 may be sized to accommodate the prosthetic heart valve when it is in a compressed configuration and disposed about the nosecone shaft 56. The handle 100 may be operated to move the outer shaft 14 between an extended state for positioning the distal capsule 16 over the prosthetic heart valve and a retracted state for removing the distal capsule 16 from the prosthetic heart valve.

[0059] 8A shows the outer shaft 14 extended to position the distal capsule 16 over the prosthetic valve 60. The distal capsule 16 can abut the nosecone 50 as shown, such that there are no gaps in the delivery device when the prosthetic heart valve is encapsulated therein. The outer shaft 14 acts as a cover for structures extending between the prosthetic valve 60 proximal end and the distal end of the multi-lumen shaft 22 (e.g., the actuation assembly 32 and a portion of the recompression shaft 80, if present). The sleeve member 34 of the actuation assembly 32 can compress the prosthetic valve 60 and provide a retaining force to prevent proximal axial displacement of the prosthetic valve 60 when the outer shaft 14 is retracted to remove the distal capsule 16 from the prosthetic valve 60.

[0060] In the example illustrated by FIG. 8A, the distal capsule 16 and the outer shaft 14 have the same diameter, which is selected to accommodate the prosthetic valve 60. As a result, the outer shaft 14 can be larger than necessary to accommodate the structure extending between the multi-lumen shaft 22 and the prosthetic valve 60. FIG. 8B shows an example in which the diameter of the distal capsule 16a is enlarged compared to the diameter of the outer shaft 14. In the example illustrated by FIG. 8B, the outer shaft 14 is sized to closely encapsulate the structure extending between the proximal end of the prosthetic valve 60 and the distal end of the multi-lumen shaft 22, while the distal capsule 16a is sized to closely encapsulate the prosthetic valve 60 in a compressed configuration. As in the previous example, the sleeve member 34 of the actuation assembly 32 can compress the prosthetic valve 60.

[0061] The combination of the sizing of the outer shaft 14 / distal capsule 16a and the retaining force of the sleeve member 34 as illustrated by Fig. 8B can prevent undesired axial displacement of the prosthetic valve 60 during removal of the distal capsule 16a from the prosthetic valve 60. Figs. 8C and 8D show the distal portion of a delivery assembly based on the principle illustrated in Fig. 8B. As shown, the prosthetic valve 60 maintains its axial position (which can be viewed relative to the nose cone 50) after retracting the outer shaft 14 to remove the distal capsule 16a from the prosthetic valve 60.

[0062] FIG 9A illustrates an alternative shaft assembly 11a. The primary difference between shaft assembly 11a and shaft assembly 11 illustrated in FIG 5A and FIG 5B is that shaft assembly 11a includes an additional shaft 30 (or "commander shaft") between outer shaft 14 and multi-lumen shaft 22. The proximal portion of commander shaft 30 may be disposed within handle 100 in the same manner that proximal portions of outer shaft 14 and multi-lumen shaft 22 are disposed within handle 100. Commander shaft 30 has extended and retracted states that correspond to the extended and retracted states of outer shaft 14, respectively.

[0063] FIG. 9B shows the commander shaft 30 and the outer shaft 14 in an extended state. In the extended state, the commander shaft 30 extends to the proximal end of the prosthetic valve 60 and covers the structure extending between the distal end of the multi-lumen shaft 22 and the proximal end of the prosthetic valve 60. The outer shaft 14 extends over the commander shaft 30 and positions the distal capsule 16 over the prosthetic valve 60. The commander shaft 30 extending to the proximal end of the prosthetic valve 60 can restrain the axial movement of the prosthetic valve 60. As shown in FIG. 9C, when the outer shaft 14 is retracted to remove the distal capsule 16 from the prosthetic valve 60, the commander shaft 30 can remain extended to the proximal end of the prosthetic valve 60 to prevent undesired proximal displacement of the prosthetic valve 60 during removal of the distal capsule 16. Once the distal capsule 16 has been removed from the prosthetic valve 60, the outer shaft 14 can be retracted further along the commander shaft 30 to expose the structure between the distal end of the multi-lumen shaft 22 and the proximal end of the prosthetic valve 60.

[0064] 10A-10D illustrate stages of a valve implantation procedure using the delivery device 12. As shown in FIG. 10A, the prosthetic valve 60 is encapsulated in the distal capsule 16 of the delivery device 12 (which can alternatively be the distal capsule 16a shown in FIG. 8B) (see FIGS. 8A, 8B, and 9B). The distal end portion of the delivery device 12 is then inserted into the patient's body and guided to the implantation site. At the implantation site, the outer shaft 14 is retracted to remove the distal capsule 16 from the prosthetic valve 60, thereby exposing the prosthetic valve 60, as shown in FIG. 10B. The prosthetic valve 60 is radially expanded to a desired working diameter, as shown in FIG. 10C.

[0065] After the prosthetic valve 60 is secured to the native anatomy, the delivery device 12 is released from the prosthetic valve 60 (e.g., by disengaging the actuation assembly 32 from the rocker / actuator 62 of the prosthetic valve 60), as shown in FIG 10D. After the delivery device 12 is released from the prosthetic valve 60, the delivery device 12 is prepared for withdrawal from the patient's body (e.g., by extending the outer shaft 14 to cover the actuation assembly 32). The delivery device 12 is then withdrawn from the patient's body.

[0066] Various functions of the delivery device 12 are accessible through the handle 100. For example, the handle 100 can include one or more mechanisms for performing one or more of the following functions: retraction of the outer shaft 14 (or any other additional associated shaft) to expose the prosthetic valve 60; expansion of the prosthetic valve 60 via the actuation assembly 32 (e.g., by pulling the actuation member 40 while keeping the sleeve member 34 compressed against the valve); recompression of the prosthetic valve 60 via the recompression member 82 (e.g., by pulling the recompression member 82 and applying tension to the distal loop 84); release of the actuation members 40 from the prosthetic valve 60 (e.g., by rotating multiple actuation members 40 simultaneously to unscrew the actuation members from corresponding rockers / actuators of the valve); and / or complementary advantageous functionality of additional handle mechanisms (which are further described below).

[0067] In the description that follows, the prosthetic valve 60 is assumed to have three rocker / actuators 62, and the delivery device 12 is assumed to have three actuation assemblies 32 for releasably engaging the three rocker / actuators 62. However, the mechanisms described in this disclosure may be adapted to support any number of actuation assemblies and rocker / actuators.

[0068] 11, an exemplary handle 100 includes a distal end 102, a proximal end 104, and a longitudinal axis 101 that extends from the distal end 102 to the proximal end 104 and defines an axial direction of the handle. The handle 100 includes a proximal portion 112 and a distal portion 110 that are coupled together and define a cavity 107 (shown in FIG. 12A) that extends from the distal end 102 to the proximal end 104. The proximal end portion of the shaft assembly 11 extends into the cavity 107.

[0069] In the implementation illustrated by FIG. 11 , the handle 100 includes a rotatable knob 120, a rotatable knob 122, and a rotatable knob 124. The rotatable knob 120 may be positioned at the distal end 102 of the handle, the rotatable knob 122 may be positioned at the proximal end 104 of the handle, and the rotatable knob 124 may be positioned at an intermediate location between the rotatable knobs 120 and 122. The handle 100 may have additional knobs, such as a slidable knob 136 and a safety knob 130. A clinician may engage the knobs to perform one or more operations of the delivery device. Surface features or textures may be formed on the knobs to assist in manually gripping and adjusting the knobs.

[0070] In one example, the rotatable knob 120 operates a first mechanism, which is capable of axially displacing the outer shaft 14 relative to the handle. In one example, the rotatable knob 122 operates a second mechanism, which is capable of expanding and recompressing the prosthetic heart valve. In one example, the rotatable knob 124 operates a third mechanism, which is capable of releasing the actuating member 40 from the prosthetic heart valve. In one example, the safety knob 130, when engaged with the rotatable knob 124, is capable of preventing unintentional release of the actuating member 40 from the prosthetic heart valve. In one example, the slidable knob 136 operates a fourth mechanism, which is capable of displacing the nosecone shaft 56 (shown in FIG. 1 ) relative to the handle.

[0071] In other implementations, the handle 100 can include a fourth rotatable knob (FIGS. 47A-48 show a handle implementation with a fourth rotatable knob 126a, 126b), which operates the steering mechanism. For example, the steering mechanism can include at least one pull wire attached at its distal end to the outer shaft 14 (or other shaft of the shaft assembly), such that rotation of the fourth knob can change tension in the pull wire, which can be effective to change the curvature of the outer shaft 14 (or the curvature of the shaft assembly). If the shaft assembly is flexible enough to navigate the curvatures of the patient's vasculature, the steering mechanism can be omitted.

[0072] 12A, 12B, and 13, a first mechanism 1000 (i.e., shaft displacement mechanism) that can be controlled by a rotatable knob 120 to displace the outer shaft 14 relative to the handle 100 includes a lead member 142, an axial guide 162, and a nut 148 (or carriage). The lead member 142 is received within a portion of a cavity 107 in the distal portion 110. A distal end portion of the lead member 142 protrudes from the distal end of the distal portion 110. In one example, the rotatable knob 120 is attached to or integrally formed with the protruding distal end portion of the lead member 142 such that rotation of the rotatable knob 120 results in rotation of the lead member 142.

[0073] The lead member 142 includes a lead bore 144 with a lead internal thread 146. An axial guide 162 is disposed within and coaxial with the lead bore 144. The axial guide 162 is axially and rotationally fixed relative to the distal portion 110, meaning that the axial guide 162 does not rotate when the lead member 142 is rotated. The axial guide 162 includes a guide central bore 164 and two guide slots 166 (see FIG. 13 ), which may have a substantially tubular profile and which extend radially outward from the guide central bore 164 in opposite directions toward the lead internal thread 146. The guide central bore 164 and the guide slots 166 extend axially along the length of the axial guide 162.

[0074] 12B, the nut 148 is disposed within an axial guide 162. The nut 148 has a nut central portion 154 and two nut radial projections 150 that extend radially outwardly from the nut central portion 154 in opposite directions toward the lead internal thread 146. The nut central portion 154 may be shaped and dimensioned to sit within the guide central bore 164, while the axial guide slots 166 may be dimensioned to receive the respective nut radial projections 150.

[0075] The outer surface of each nut radial projection 150 includes a nut outer thread 152 (see FIG. 13) which engages the lead internal thread 146 through an axial guide slot 166 (see FIG. 13). Thus, rotation of the lead member 142 by the rotatable knob 120 results in translation of the nut 148 along the axial guide 162. The axial guide 162 ensures that translation of the nut 148 can only occur along the handle axis and prevents rotational movement of the nut 148.

[0076] The nut center portion 154 has a nut bore 156 that extends through the nut center portion 154. The nut bore 156 has a nut distal bore portion 158 having a first diameter and a nut proximal bore portion 159 having a second diameter smaller than the first diameter. A shoulder or step 157 is formed at the transition between the nut distal bore portion 158 and the nut proximal bore portion 159. The proximal end portion 18 of the outer shaft 14 extends into the nut distal bore portion 158 and abuts the shoulder 157.

[0077] The proximal end portion 18 of the outer shaft 14 may be rigidly coupled to the nut 148, for example, by attaching the proximal end portion 18 to the nut distal portion 158 and / or shoulder 157 using any suitable method (e.g., gluing, welding, clamping, screwing, etc.). The rigid connection between the proximal end portion 18 and the nut 148 will allow the outer shaft 14 to move axially when the nut 148 moves axially in response to rotation of the rotatable knob 120 and lead member 142.

[0078] The length of the lead bore 144, the length of the axial guide 162, and / or the length of the nut 148 can be selected to provide a desired range of axial translation of the outer shaft 14. The number and spacing of mating threads in the lead internal threads 146 and the nut external threads 152 can be selected to provide a desired ratio between the amount of rotation of the rotatable knob 120 and the range of axial translation of the outer shaft 14. In some cases, the nut 148 can have a nut distal extension 160 that allows the length of the nut distal bore portion 158 to be extended without adjusting the axial length of the nut radial projection 150. A longer nut bore 156 can improve engagement between the nut 148 and the proximal end portion 18 of the outer shaft 14.

[0079] The rotatable knob 120 is configured to operate the first mechanism 1000 to axially displace the outer shaft 14. For example, rotation of the rotatable knob 120 in a first direction can advance the outer shaft 14 distally, and rotation of the rotatable knob 120 in a second direction opposite the first direction can retract the outer shaft 14 proximally.

[0080] Prior to inserting the distal end portion of the delivery device 12 into the patient's body, distally oriented movement of the outer shaft 14 can be used to position the distal capsule 16, 16a of the delivery device 12 above the prosthetic valve 60 (see FIG. 10A). At the implantation site, proximally oriented movement of the outer shaft 14 can be used to expose the prosthetic valve 60 (see FIG. 10B). After the actuation member 40 is released from the prosthetic valve 60 (see FIG. 10C), distally oriented movement of the outer shaft 14 can be used to place the outer shaft 14 in close proximity to the nose cone 50, ensuring that the delivery device 12 can be easily withdrawn without encountering resistance that might otherwise occur between the patient's anatomy and the exposed boundary of the nose cone 50.

[0081] The first mechanism 1000 can include a guide head 168 disposed adjacent the proximal end of the axial guide 162. In one example, the guide head 168 is rotationally and axially fixed relative to the distal portion 110. In some cases, the guide head 168 can be integrally formed with the proximal end of the axial guide 162, in which case the guide head 168 can alternatively be referred to as a guide proximal body portion 168. As shown more clearly in FIG. 14A, the guide head 168 has a central bore 169 that is aligned with the central bore 164 of the axial guide 162. A shoulder 170 can be formed between the distal portion 169a and the proximal portion 169b of the central bore 169.

[0082] As shown in FIGS. 12A and 12B, the multi-lumen shaft 22 extends through the outer shaft 14 into the guide central bore 164 of the axial guide 162. As shown in FIG. 14A, the multi-lumen shaft 22 further extends into the distal portion 169a of the central bore 169 of the guide head 168. In one example, the proximal end of the multi-lumen shaft 22 includes a flange 128 with openings that match the lumens 23, 24, 25 (see FIG. 5B) of the multi-lumen shaft 22. The actuation member 40, the nosecone shaft 56, and the recompression member 82 can extend into the handle cavity 107 through respective openings in the flange 128. In one example, the flange 128 can be attached to a proximal shoulder 170 of the guide head 168 such that the multi-lumen shaft 22 is rotationally and axially fixed relative to the guide head 168.

[0083] As shown in FIG. 14A, the guide head 168 can further include an opening 171 that is fluidly connected to the proximal portion 169b of the central bore 169. A fitting 176 is seated in the opening 171. A flushing port 180 can be connected to the fitting 176 (as shown in FIG. 14B). The flushing port 180 can be a flexible tube with an internal conduit. The flushing port 180 can extend along the cavity 107, through an opening in the distal portion 110, to the outside of the handle 100 (as shown in FIG. 11). A connector 178 (e.g., a stopcock Luer connector, etc.) can be provided at an end of the flushing port 180 that is disposed on the outside of the handle 100 (as shown in FIG. 11). Fluid can be supplied through the flushing port 180 into the proximal portion 169b of the central bore 169. Fluid can enter the lumens of the multi-lumen shaft 22 through the openings in the flange 128, thereby allowing flushing of the lumens of the multi-lumen shaft 22.

[0084] 14C shows another example, where guide head 168 (integrally formed with the proximal end of axial guide 162) includes an opening 171a that is oriented radially relative to the longitudinal axis of the handle. Opening 171a is aligned with a similar opening in distal portion 110. A flushing port 180 extends from outside the handle into opening 171a and can be used to flush the lumen of the shaft within the handle.

[0085] 15A-15D, guide plates 173, 175 may be attached to the proximal end of guide head 168. Guide plates 173, 175 may have a central opening for passage of actuation member 40, recompression member 82, and nosecone shaft 56 into handle cavity 107. In one example, spreader plate 172 may be positioned proximal to guide plate 175. In some cases, spreader plate 172 may be fixedly coupled to guide plate 175 or may be otherwise fixed to multi-lumen shaft 22. Spreader plate 172 includes apertures 174 for receiving actuation member 40 and recompression member 82. The spacing between apertures 174 is greater than the spacing between the lumens from which actuation member 40 and recompression member 82 emerge, allowing actuation member 40 and recompression member 82 to be spread proximally.

[0086] 16A, each actuation assembly 32 may further include an actuation tube 364, which may be positioned within a cavity of the handle and proximal to the multi-lumen shaft 22 (e.g., as shown in FIG. 15D). An actuation member 40 extends through each actuation tube 364. The actuation member 40 may include an actuation torque transmission portion 42 and an actuation flexible portion 46. The actuation torque transmission portion 42 extends into the handle from a distal threaded head 44. The actuation flexible portion 46 is disposed proximal to and coupled to the actuation torque transmission portion 42.

[0087] The actuation torque transmission portion 42 can include a relatively rigid material, formed as a torque transmission wire, cable, or the like. The actuation flexible portion 46 can be formed as a flexible string, wire, cable, or the like, and can be configured to be flexible enough to be wrapped around various components (e.g., pulleys or reels, etc.). The actuation member 40 passes through the actuation tube 364, such that the actuation flexible portion 46 extends proximally from the actuation tube 364 for routing around a pulley or the like. In some cases, the actuation torque transmission portion 42 can be rigidly attached to the actuation tube 364, such that both can move axially together through the handle. In some cases, the actuation tube 364 can include a distal portion 366, which is provided with an enlarged diameter and which can include a coupler configured to couple the actuation torque transmission portion 42 to the actuation flexible portion 46.

[0088] Referring to FIG. 16B, a load cell 182 (which is an example of a force sensor) may be disposed between the guide head 168 and the internal radial extension of the handle. As the prosthetic valve 60 is expanded, the resistive force of the sleeve member 34 compressing against the housing member 64 of the rocker / actuator 62 is converted through the multi-lumen shaft 22 and the flange 28 into a proximally directed force 185 of the guide head 168 and applied to the load cell. The axial force measured by the load cell 182 may be used to calculate the radial force applied by the valve 60 against the surrounding native anatomical structure (e.g., the native aortic annulus, etc.). The load cell 182 may be operably coupled to an external device via one or more wires or cables 184. Alternatively or additionally, the load cell is capable of wirelessly transmitting a signal to the external device.

[0089] 17-19 illustrate various portions of the second mechanism 1100 (i.e., the valve expansion and compression mechanism) that may be controlled by the rotatable knob 122 of the handle. The second mechanism 1100 may be controlled to simultaneously pull all of the actuation members 40 of the actuation assembly 32, thereby expanding the prosthetic heart valve attached to the actuation members 40. In some examples, the second mechanism 1100 may be controlled to pull the recompression member 82, thereby recompressing the valve. In some examples, the rotatable knob 122 may control both the expansion and recompression parts of the mechanism 1100. For example, rotation of the rotatable knob 122 in a first direction, which may be clockwise or counterclockwise, may result in expansion of the prosthetic heart valve, and rotation of the rotatable knob 122 in a second direction opposite the first direction may result in compression of the valve. The movements of the actuating member 40 and the recompression member 82 may be synchronized so that the expansion and recompression parts of the mechanism do not interfere with each other.

[0090] In one implementation, the second mechanism 1100 can include a force balancing assembly 250, a tensioning assembly 256 (separately identified as 256a, 256b), and a rerouting pulley 246. The force balancing assembly 250 can balance the pulling forces applied to the actuation members 40 (separately identified as 40a, 40b, 40c), thereby reducing the risk of overloading any one of the rockers / actuators of the prosthetic valve. The tensioning assemblies 256a, 256b can maintain a minimum tension in the actuation members 40 and the recompression member 82, respectively.

[0091] In one example, the force balancing assembly 250 can include a first balancing pulley 252 and a second balancing pulley 254, each of which can freely rotate about its axis within the assembly. The first and second actuating flexible portions 46a, 46b of the first and second actuating members 40a, 40b extend proximally (i.e., toward the proximal end of the handle) from the respective actuating tubes 364a, 364b and are connected together to form a single flexible portion that is routed around the first balancing pulley 252. The first balancing pulley 252 can freely rotate about its axis and transmit tension between the actuating flexible portions 46a, 46b. As a result, no tension difference is generated between the actuating flexible portions 46a, 46b.

[0092] The third actuating flexible portion 46c of the third actuating member 40c extends proximally from the actuating tube 364c and through the first tensioning assembly 256a. Section 46c-1 of the third actuating flexible portion 46c extends proximally from the first tensioning assembly 256a to and around the rerouting pulley 246. Section 46c-2 of the third actuating flexible portion 46c extends distally from the rerouting pulley 246 into the force balancing assembly 250 and around the second balancing pulley 254. The third section 46c-3 extends proximally again from the second balancing pulley 254.

[0093] The rotatable knob 122 can be rotated to apply a pulling force to the section 46c-3 of the third actuating flexible portion 46c, which generates a tension in the third actuating flexible portion 46c. This tension is translated into an axial movement of the force balancing assembly 250 as a whole, which results in tension in both the first and second actuating flexible portions 46a, 46b, thus maintaining equal tension at all times among all actuating flexible portions 46a, 46b, 46c. In this manner, it is sufficient to apply a pulling force to a single actuating flexible portion (specifically, the third actuating flexible portion 46c), which simultaneously pulls all three actuating members 40a, 40b, 40c along equal distances.

[0094] Further details of the force balancing assembly, including examples of its use in implementations having four or more actuation assemblies, can be found in U.S. Provisional Application No. 62 / 945,039, which is incorporated herein by reference.

[0095] The recompression member 82 may be released while the rotatable knob 122 is rotated in one direction to pull the third actuating flexible portion 46c, and the third actuating flexible portion 46c may be released while the second knob is rotated in the opposite direction to pull the recompression member 82. Preferably, the third actuating flexible portion 46c and the recompression member 82 are maintained in a minimally tensioned state at all times (including their released phases) to prevent the formation of slack in the handle, since slack formed in the handle would result in an imbalance of synchronization between the third actuating flexible portion 46c and the recompression member 82 during rotation of the rotatable knob 122 in either direction. The third actuating flexible portion 46c and the recompression member 82 may be maintained in a minimally tensioned state by respective tensioning assemblies 256a, 256b.

[0096] 20A, in one example, tensioning assembly 256 (which may be used as either tensioning assembly 256a or 256b) includes a housing 257 and a tensioning spring 258 that is attached to one end of housing 257. Tensioning assembly 256 includes a spring slider 260 that is disposed in a spring slider slot 262 formed in housing 257. Spring slider 260 is axially movable within spring slider slot 262.

[0097] The spring slider 260 may be coupled at one end to the spring 258 and at another end to a flexible string that needs to be tensioned (e.g., the actuation flexible portion 46c or the recompression member 82). The actuation flexible portion 46c (or, in a similar manner, the recompression member 82) may be attached to or may extend through an eyelet of the spring slider 260. The spring slider 260 may include a ping 264 that extends through and is coupled to the free end of the spring 258. In one example, the spring 258 may be a constant force spring.

[0098] In use, when a pulling force is applied to actuation flexible portion 46c (or recompression member 82), spring slider 260 may slide proximally (i.e., in direction d1) within spring slider slot 262, for example, until spring slider 260 reaches proximal slot stop feature 266 (e.g., a vent or protruding extension configured to prevent further proximal movement of slider 260). At this point, if further pulling force is applied, the entire tensioning assembly 256 may translate proximally along with actuation member 40c (or along with recompression member 82). When the actuating flexible portion 46c (or recompression member 82) is released from the tension force, the spring 258 (which can be a constant load spring) pulls the slider 260 distally through the slot 262 (i.e., in the direction d2), thereby tensioning the actuating member 40c (or recompression member 82) sufficiently to prevent slack formation.

[0099] FIG. 20B illustrates an alternative tensioning assembly 256' that uses a tension spring 258' instead of a constant force spring. The alternative tensioning assembly 256' can include a housing 257' having a slot 262' with a tension spring 258' and a slider 260' disposed within the slot 262'. The spring 258' is attached to the slider 260' such that the slider 260' can move axially within the slot 262' in response to changes in tension in the spring 258'. The actuation flexible portion 46c (or recompression member 82) extends through the spring 258' and is coupled to the slider 260'.

[0100] When a tension force is applied to the actuation flexible portion 46c (or recompression member 82), the slider 260' can slide proximally within the slot 262'. When the actuation flexible portion 46c (or recompression member 82) is released from the tension force, the spring 258' pulls the slider 260' distally within the slot 262', thereby tensioning the actuation member 40c to prevent slack formation. It has been found that a small sized tension spring 258' can be used in place of the constant force spring 258 because the tension force that the spring needs to apply to tension the actuation member 40c (or recompression member 82) is relatively small. This configuration can advantageously provide a more compact small sized tensioning assembly.

[0101] In some cases, the handle 100 can include one or more mechanisms for limiting the amount of force that can be applied to expand or compress the prosthetic valve. For example, the handle 100 can include force-limiting mechanisms 234 (separately identified as 234a, 234b). The first force-limiting mechanism 234a is coupled to the third actuation flexible portion 46c and can limit the amount of force that can be applied to expand the prosthetic valve 60 by rotation of the rotatable knob 122. The second force-limiting mechanism 234b is coupled to the recompression member 82 and can limit the amount of force that can be applied to compress the prosthetic valve 60.

[0102] 21A and 21B illustrate an example force-limiting mechanism 234 that includes a pivot arm 236 having a first end portion 238 pivotally coupled to a base portion 248. The force-limiting mechanism 234 can include an arm pulley 242 that is coupled to a second end portion 240 of the pivot arm 236. The force-limiting mechanism 234 can further include a guide pulley 244 (shown in FIG. 18 ), which is laterally and / or axially offset from the pivot arm 236. The guide pulley 244 can extend along a plane that is substantially perpendicular to the plane of the arm pulley 242.

[0103] 18, a section 46c-3 of the actuating flexible portion 46c extending proximally from the force balancing assembly 250 may be routed around the first pivot arm 236a of the first force limiting mechanism 234a and partially routed around the first arm pulley 242a. A subsequent section 46c-4 of the actuating flexible portion 46c extends from the arm pulley 242a to the first guide pulley 244a. The actuating flexible portion 46c is partially routed around the first guide pulley 244a and thereby redirected such that a subsequent section 46c-5 of the third actuating flexible portion 46c extends toward the expansion reel 270 and has its proximal end attached to the expansion reel 270. In this manner, rotation of the expansion reel 270 in a particular direction can cause the third actuating flexible portion 46c to wrap around the expansion reel 270, tensioning the actuating flexible portion 46c and simultaneously pulling all three actuating members 46a, 46b, 46c, as previously described.

[0104] Similarly, section 82-1 of recompression member 82 extends proximally from second tensioning assembly 256b. Section 82-1 is routed around second pivot arm 236b of second force limiting mechanism 234b and partially routed around second arm pulley 242b. Subsequent section 82-2 of recompression member 82 extends from arm pulley 242b to second guide pulley 244b. Recompression member 82 is partially routed around second guide pulley 244b, thereby redirecting subsequent section 82-3 extending towards recompression reel 272 and having its proximal end attached thereto. Thus, rotation of recompression reel 272 in a direction opposite to the applied expansion direction can wrap recompression member 82 around recompression reel 272, tensioning recompression member 82 and recompressing valve 60.

[0105] Due to the routing of the actuating member 40c around the arm pulley 242a and the guide pulley 244a, when a pulling force is applied to the actuating member 40c, a pivoting force is applied to the pivot arm 236a, causing the arm to pivot. When the pivot arm 236a pivots to a certain extent corresponding to a maximum predefined pulling force, the actuating member 40c is pinched in the gap between the first end portion 238a and the base portion 248a (as shown in FIG. 21B), thereby preventing the actuating member 40c from being pulled further by the extension reel 270.

[0106] Similarly, when a pulling force is applied to the recompression member 82, a pivoting force is applied to the arm 236b, causing the arm to pivot. When the pivoting arm 236b pivots to a certain extent corresponding to a maximum predefined pulling force, the recompression member 82 is pinched in the gap between the first end portion 238b and the base portion 248b (as shown in FIG. 21B), thereby preventing the recompression member 82 from being further pulled by the recompression reel 272.

[0107] Further details regarding the force-limiting mechanism 234 and alternative examples thereof are detailed in US Pat. No. 6,399,323, the disclosure of which is incorporated herein by reference.

[0108] 21C illustrates an adjustable biasing assembly 220 that can be positioned to bias a pivot arm 236 of a force-limiting mechanism 234 to a released position. The adjustable biasing assembly 220 includes a biasing spring 232 (or any other biasing member) disposed between a stationary fixed end and the pivot arm 236. The adjustable biasing assembly 220 can further include an adjustment nut 224 that can be rotated to adjust the degree of pre-expansion or pre-compression of the spring 232. Each of the pivot arms 236a, 236b of the force-limiting mechanisms 234a, 234b can be provided with an adjustable biasing assembly 220a, 220b.

[0109] 22A-22C illustrate an implementation of an adjustable biasing assembly 220 including a plunger 222 that is axially movable within a cylinder 226. A biasing spring 232 is disposed around the plunger 222 between an adjustment nut 224 and a distal edge of the cylinder 226. The cylinder 226 is attached at an opposite mounting end 230 to a pivot arm 236, more specifically to a first end portion 238 of the pivot arm 236 of the force limiting mechanism (see FIG. 21C ). When a force is applied to pivot the arm 232 toward the clamping position, the first end portion 238 of the arm pushes the cylinder 226 toward the adjustment nut 224 in a distally oriented direction, compressing the biasing spring 232. The adjustment nut 224 can be preset to a desired position to preset the resistance force of the spring 232. When force is no longer applied to the arm 236 (by the third actuation member 40c or the recompression member 82), the spring expands, urging the arm 236 towards its released position.

[0110] The rotatable knob 122 may be coupled to the expansion reel 270 and the recompression reel 272 such that rotation of the rotatable knob 122 in a particular direction (which may be clockwise or counterclockwise) translates to rotation of both reels 270, 272 in the same direction, and rotation of the rotatable knob 122 in the opposite direction causes both reels 270, 272 to rotate therewith in the opposite direction. In one example, the third actuation flexible portion 46c and the recompression member 82 are attached to the expansion reel 270 and the recompression reel 272, respectively, from opposite directions (as shown in FIG. 18). When both reels are rotated in a particular direction (e.g., a direction configured to expand the prosthetic valve 60), the third actuation flexible portion 46c is wound around the expansion reel 270, while the recompression member 82 is unwound from the recompression reel 272. Similarly, when both reels are rotated in opposite directions (e.g., in a direction configured to compress the artificial valve 60), the recompression member 82 is wound around the recompression reel 272, while the third actuating flexible portion 46c is unwound from the expansion reel 270.

[0111] 23A-24C illustrate a force limiting mechanism 634 with an adjustable biasing assembly 620 that can serve as an alternative to the previously described force limiting mechanism 234 with adjustable biasing assembly 220. The force limiting mechanism 634 includes a base guide member 630. The adjustable biasing assembly 620 includes a plunger 622 having a proximal portion thereof axially movable within a respective bore of the base guide member 630. A distal portion 626 of the plunger 622 is attached to or integrally formed with a distal pulley housing 636 having a distal pulley 638 coupled to an internal passage thereof. The adjustable biasing assembly 620 includes a biasing spring 632 disposed about the plunger 622 and an adjustment nut 624. A biasing spring 632 extends between the base guide member 630 and the adjustment nut 624 .

[0112] In some examples, the force-limiting mechanism 634 further includes a proximal plate 650 coupled to or integrally formed with the rotatable knob 122 and configured to rotate therewith. The plate 650 includes at least one set of circumferential serrations, and the plunger 622 includes plunger proximal teeth 628 configured to engage the serrations. FIGS. 24A-C show different views of the proximal plate 650.

[0113] In one example, the proximal plate 650 can have two sets of circumferential serrations: outer serrations 652 and inner serrations 654, with the inner serrations 654 disposed radially inward relative to the outer serrations 652. The force-limiting mechanism 634 can have two adjustable biasing assemblies 620a, 620b, as shown in FIG. 23E. The adjustable biasing assembly 620a can be configured to cooperate with the third actuation flexible portion 46c, with the adjustable biasing assembly 620a having its plunger proximal teeth 628a radially aligned for engagement with the outer serrations 652. The adjustable biasing assembly 620b can be configured to cooperate with the recompression member 82, the adjustable biasing assembly 620b having its plunger proximal teeth 628b radially aligned for engagement with the internal serrated teeth 654.

[0114] As shown in FIG. 23B, for the adjustable biasing assembly 620a, the section 46c-3 of the third actuation flexible portion 46c extends proximally from the force balancing assembly 250 (similar to FIGS. 17 and 18) toward and around a reverting pulley 642a and reverts its subsequent extension 46c-4 in a distal direction. The reverting pulley 642a can be coupled to the base guide member 630a, for example. The subsequent section 46c-4 extends from the reverting pulley 642a toward and around the distal pulley 238a and reverts its subsequent extension 46c-5 in a distal direction. The subsequent section 46c-5 extends from the distal pulley 238a towards and is partially routed around the guide pulley 644a, such that the subsequent section 46c-6 extends from the guide pulley 644a to the expansion reel 270.

[0115] In use, when the rotatable knob 122 is rotated in a direction configured to drive expansion of the prosthetic valve 60, section 46c-6 of the third actuation flexible portion 46c wraps around the expansion reel 270, while subsequent sections 46c-5 and 46c-4 of the third actuation flexible portion 46c extend around the adjustable biasing assembly 620a in a manner configured to pull the plunger 622a proximally toward the plate 650. The plunger proximal teeth 628a are axially offset and distal to the outer serrated teeth 652 when the prosthetic valve 60 is in a compressed state. As the plunger 622a translates axially in the proximal direction during valve expansion, the proximal teeth 628a move closer to the outer serrations 652 until they engage the outer serrations 652 in a ratcheting manner that prevents further proximal movement of the plunger 622a. This engagement serves to prevent further rotation of the rotatable knob 122 in the same direction, thereby preventing further expansion of the prosthetic valve 60.

[0116] The outer serrated teeth 652, when engaged with the plunger proximal teeth 628, are angled to prevent further rotation (i.e., expansion) of the second knob in the same direction, but the teeth 628 are permitted to slide along the teeth 652 when the second knob is rotated in the opposite direction (i.e., to recompress the prosthetic valve 60 while releasing the third actuating flexible portion 46c).

[0117] The adjustment nut 624 can be preset to a desired position to set the resistive force of the spring 632. When force is no longer applied to the plunger 622 by further rotation or by holding the second knob in place (assuming the prosthetic valve 60 is not locked in the expanded state by the rocker / actuator 62), the spring 632 can expand and urge the plunger 652 back to its released position.

[0118] In some examples, the handle can include a distal stop feature 640 (shown in FIG. 23B ) that is positioned distally of the distal pulley housing 636 and cannot move relative to the handle. The distal stop feature 640 can be configured to limit a maximum translation of the plunger 622 in a distal direction. In some examples, the plunger 622 can be movable within a channel, such that a distal end of the channel serves as the distal stop feature 640.

[0119] The function of the adjustable biasing assembly 620b is similar to that of the adjustable biasing assembly 620a, where the recompression member 82 is configured to pull the plunger 222b toward the inner serrated teeth 654 upon rotation of the rotatable knob 122 in a direction configured to recompress the prosthetic valve 60, and stops when the plunger proximal teeth 628b engage the inner serrated teeth 654.

[0120] In some instances, the lateral edges of the plunger proximal teeth 628a, 628b are angled to properly abut the serrated teeth 652, 654.

[0121] In some cases, the handle 100 can include a mechanism to prevent overexpansion of the prosthetic valve, minimizing the risk of rupturing the valve annulus or damage to the surrounding anatomical structures.

[0122] 25A-25C illustrate an exemplary valve expansion limiting mechanism 400 including a primary gear 420 having external gear teeth and a secondary gear 422 having external gear teeth that interconnect with the external gear teeth of the primary gear. The primary gear 420 is coupled to the rotatable knob 122 and rotates therewith. The secondary gear 422 includes a threaded bore. A rod 424 is threadedly engaged with the threaded bore such that when the primary gear 420 rotates in a direction to pull the third actuation member 40c, the secondary gear 422 rotates in an opposite direction, which translates into axial displacement of the rod 424 in a proximal direction. The proximal portion of the rod 424 is threaded along a sufficient length for the required range of axial displacement thereof. The rod 424 includes a radially extending tab 426 that extends through a longitudinal slot 428 in the handle 100. Thus, the tab 426 is guided proximally along the slot 428 during retraction of the actuation member 40c.

[0123] The valve expansion limiting mechanism 400 may further include a slidable knob 430 configured to slide along a transverse slot 432 such that in a first position, the knob 430 does not overlap the longitudinal slot 428 and in a second position (shown in FIG. 25A ), the knob 430 overlaps the longitudinal slot 428. When the knob 430 is positioned in the first position, the tab 426 is free to move axially in a proximal direction toward the proximal end 104 of the handle 100 along the entire path defined by the slot 428. When the knob 430 is in the second position, the knob 430 obstructs the path defined by the slot 428 such that the tab 426 can only move axially until the tab 426 contacts the knob 430. At this point, any further movement of the tab 426 in the same direction is obstructed by the knob 430. Because the tab 426 (and attached rod 424) has stopped and cannot move further in the proximal direction beyond the position where the tab 426 abuts the knob 430 in the second position, the rest of the components involved in the movement transmission (including the secondary gear 422 and the primary gear 420) will likewise stop, thus preventing further retraction of the third actuation member 40c. When the third actuation member 40c stops, the prosthetic valve 60 is prevented from expanding any further. Thus, the position of the knob 430 defines the maximum allowed expansion of the valve 60. If the user desires further expansion of the valve, the user can manually slide the knob 430 to the first position.

[0124] The valve expansion limiting mechanism 400 may further include a clicking mechanism that produces a clicking sound in response to the movement of the knob 430 from a first position to a second position. As shown in FIG. 25B and FIG. 25C, the clicking mechanism may include a stationary member 438 having an axial protrusion (e.g., in the form of a dimple) in front of the base member 434 of the knob 430. The base member 434 may be provided with two notches 436. The clicking sound is produced when the knob 430 slides with the base member 434 from one position to another and the protrusions of the stationary member 438 flexibly move above the corresponding notches 436.

[0125] 26A-26C illustrate an alternative valve expansion limiting mechanism 400a in which the primary gear with external gear teeth (420 in FIGS. 25A and 25B) is replaced by an internally threaded nut 420a configured to threadingly engage a proximal threaded portion 422a of a rod 424a. Rotation of the nut 420a during retraction of the third actuation member 40c is translated into axial movement of the tab 426a via the proximal threaded portion 422a of the rod 424a, and functions in an otherwise similar manner to that described above with reference to FIGS. 25A and 25B.

[0126] In one example, the tab 426, 426a is removably attachable to the rod 424, 424a such that it can be positioned at different locations along the length of the rod 424, 424a. As shown in FIG. 26B, the tab 426a can be attached to the rod 424a by a set screw 427. If it is desired to set the maximum allowable expansion by the mechanism to a higher value, the set screw 427 can be released and the tab 426a can be displaced axially to a more distal position and then reattached to the rod 424a in the new position by screwing in the set screw 427a. If it is desired to set the maximum allowable expansion to a lower value, the same procedure can be performed, positioning the tab 426a at a more proximal location along the rod 424a. The same procedure can also be performed to recalibrate the mechanism to accommodate different valve sizes.

[0127] According to some examples, the handle 100 can include multiple knobs spaced axially from one another. FIG. 26C shows a series of knobs 430a slidable in respective lateral slots. Each knob 430a position corresponds to a different expansion diameter. The knobs 430a can act as switches that allow a single handle to be used with different valve sizes or according to different patient anatomies. For example, a clinician can slide a knob 430a having a desired maximum expansion limit to a second position while keeping the remaining knobs 430a at rest in a first position. Such a configuration can also be used to provide an expansion fine adjustment function, where some knobs 430a can be positioned in a second position, allowing the clinician to slide each of the knobs 430a to the first position to allow further expansion of the valve.

[0128] The handle 100 can include a status indicator mechanism to provide an indication regarding the valve expansion diameter.

[0129] An exemplary status indicator mechanism 450 is shown in Figures 27A-28C. Mechanism 450 is shown in a first state in Figures 27A-27C and in a second state in Figures 28A-28C. In some examples, the first state can be a state in which the prosthetic valve 60 is compressed and the second state can be a state in which the prosthetic valve 60 is fully expanded, with any transition state between the first and second states indicating the current valve diameter.

[0130] 27A-27C, the status indicator mechanism 450 can include a radial extension 228 (shown in FIG. 27C) that extends outwardly from a cylinder 226 (see FIGS. 22A-22C) of the adjustable biasing assembly 220 (see FIGS. 22A-22C). The status indicator mechanism 450 can further include a pivot member 447 (shown in FIG. 27C) that is configured to pivot about a hinge that is fixedly attached to the handle 100 (e.g., to the proximal portion 112). The status indicator mechanism 450 can include an indication tab 440 and a transition arm 446.

[0131] The pivot member 447 includes a first portion 447a (lower portion in FIG. 27C ) configured to contact the radial extension 228 during at least the second state of the status indicator mechanism, and a second portion 447b (upper portion in FIG. 27C ) rotatably connected to a transition arm 446. The transition arm 446 is connected at its opposite end to an indication tab 440, which may be formed, for example, as a slidable knob. The indication tab 440 is configured to slide axially in a slot 442 in the handle 100, such that the position of the indication tab 440 (between the distal and proximal ends of the slot) is visible to an operator or user of the device through the slot 442.

[0132] The status indicator mechanism 450 can include a tab spring 444 that is connected at its proximal end to the indication tab 440 and at its distal end to the handle 100. The tab spring 440 is a tension spring that is shown in a free compressed state when the status indicator mechanism is in a first state as shown in Figures 27A-27C.

[0133] 28A-28C show the status indicator mechanism 450 in a second state. When the third actuating member 40c is pulled in the proximal direction d1, the pivot arm 236 rotates about its hinge 128 in the direction c4. The rotation of the arm first end portion 236 in the direction c4 translates into axial movement of the cylinder 226 in the distal direction d2, acting to compress the spring 232.

[0134] The pivot member 447 is positioned such that its lower portion 447a (shown in FIG. 27C) is configured to slide over the radial extension 228 (shown in FIG. 27C) when the cylinder 226 translates in the distal direction d2 during the transition from the first state (FIGS. 27A-27C) to the second state (FIGS. 28A-28C). As a result, the pivot member 447 rotates about its hinge such that its upper portion rotates in the direction c3, pulling the transmission arm 446 along with it. The transmission arm 446 translates the rotational movement of the pivot member 447 into axial movement of the indication tab 440, which is pulled axially in the proximal direction d1 toward the proximal end of the slot 442.

[0135] When the third actuation member 40c is released, the spring 444 returns to its extended state such that the lower portion of the pivot member 447 no longer abuts the outer edge of the radial extension 228, thereby releasing the indication tab 440. The tab spring 444 returns to its free compressed state, pulling the indication tab 440 along therewith toward the distal end of the slot 442 such that the status indicator mechanism returns to the first condition of Figures 27A-27C.

[0136] In some examples, the handle 100 can include markings in or near the slot 442 to provide an easy visual indication of safe or unsafe areas and allow the clinician to compare the current position of the indication tab 440 to such markings.

[0137] 29A and 29B illustrate a portion of a third mechanism 1200 (i.e., an actuation release mechanism) that may be controlled by the handle's rotatable knob 124. As shown, the third mechanism 1200 may include a gear train 345, which is driven by the rotatable knob 124.

[0138] In one implementation, the gear train 345 includes an annular driver gear 344 and one or more driven pinion gears 356 (e.g., three pinion gears). The gear train 345 may further include one or more idler gears 350 (e.g., two idler gears). The rotatable knob 124 may be attached to the annular driver gear 344 such that rotation of the rotatable knob 124 in a first direction causes rotation of the annular driver gear 344 in the same direction. The rotatable knob 124 may include a protrusion 322 extending radially inward. The annular driver gear 344 may include a recess 346 that receives and mates with the protrusion 322.

[0139] The annular driver gear 344 can include driver gear inner teeth 348 that mesh with idler gear teeth 352 of the idler gear 350. The idler gear teeth 352 can then mesh with pinion gear teeth 358 of the pinion gear 356. The annular driver gear 344 can be configured to mesh with and drive the two idler gears 350. One of the two idler gears 350 can be configured to mesh with and drive the single third pinion gear 356, while the other idler gear 350 can be configured to mesh with and drive the single third pinion gear 356. Although two idler gears 350 are shown for illustrative purposes, any number of idler gears may be used to translate the rotational movement of the annular driver gear 344 into the rotational movement of the pinion gear 356. In other examples, the idler gear 350 may be omitted and the pinion gear 356 may be designed to directly contact and mesh with the driver gear teeth 348.

[0140] Each pinion gear 356 can include a pinion gear bore 360 ​​configured to receive an actuation tube 364 therein. In one example, the gear bore 360 ​​can have a non-circular profile adapted to match the non-circular profile of a portion of the actuation tube 364 extending therethrough. For example, the gear bore 360 ​​can have a flat edge 362. The non-circular profile of the portion of the actuation tube 364 can allow the torque shaft to move freely in a proximal or distal axial direction relative to the pinion gear 356. At the same time, when the pinion gear 356 is driven by the driver gear 344, the actuation tube 364 rotates in the same direction as the pinion gear.

[0141] When the rotatable knob 124 is rotated in a first direction, which can be clockwise or counterclockwise, all three actuation tubes 364 are rotated via the gear train (i.e., via the drive gear 344, the idler gear 350, and the driven pinion gear 356). As the actuation member torque transmitting portions 42 are attached to the actuation tubes 364, they are caused to rotate about their respective central axes and transmit rotational movement to their respective distal threaded heads 44, which can be unscrewed and disengaged from the rack member 68.

[0142] The safety knob 130 (see FIG. 11 ) can be configured to slide into a recess 134 in the rotatable knob 124. When the safety knob 130 is disposed in the recess 134, rotation of the rotatable knob 124 is prevented. This serves as a safety measure to prevent unintentional release of the delivery device from the prosthetic valve. Once the prosthetic valve is sufficiently expanded, the safety knob 130 can be pushed along the slot 132 (shown in FIG. 11 ) and away from the recess 134 to allow manual rotation of the third knob 124.

[0143] In some cases, rotation of the rotatable knob 124 in a first direction is translated into a rotation of each of the actuation torque transmitting portions 42 about their respective longitudinal axes, allowing the actuation torque transmitting portions 42 to disengage from the prosthetic heart valve, while preventing rotation of the rotatable knob 124 in a second direction opposite the first direction. This can advantageously avoid damage that could otherwise result from over-tightening the distal threaded head 44 due to accidental rotation of the rotatable knob 124 in the wrong direction.

[0144] A ratchet mechanism may be provided that allows the rotatable knob 124 to rotate in only one direction. With reference to FIGS. 30A and 30B , in one implementation, the ratchet mechanism may include a pawl member 324 that is spring biased against the inner teeth 320 of the rotatable knob 124. The pawl member 324 may be retained within a channel 336 of a pawl member housing 334. The pawl member 324 may include an outwardly facing portion 326 that is configured to bear against the inner teeth 320 of the rotatable knob 124. The outwardly facing portion 326 extends between an outwardly facing end 328 that is configured to contact the inner teeth 320 and a pawl member shoulder 330 formed at an opposite end thereof.

[0145] As shown in FIGS. 30A and 30B, the opposite end portion of the pawl member 324 extends radially outward from the channel 336 and the housing 334. The opposite end portion of the pawl member 324 can include a circumferential groove 332 that is configured to receive a fastener, such as a disk 340. The pawl member housing 334 can include a ridge 338 at its radially innermost end that extends toward the pawl member 324 such that the fastener 340 can abut or be pressed against the ridge 338. While the fastener 340 is shown as a disk in the illustrated example, it will become apparent that a variety of other fasteners, such as a cotter pin, can be utilized. In one example, the ridge 338 can be formed by a bent end of the pawl member housing 334, as shown in FIG. 30A.

[0146] A pawl spring 342 may be positioned above the pawl member 324 between the housing ridge 338 and the pawl member shoulder 330 to constantly bias the outward portion 326 against the inner teeth 320 of the third knob. As shown in FIG. 30B, the inner teeth 320 of the rotatable knob 124 may be angled in a particular direction and the outward end 328 of the pawl member 324 may be similarly angled so that the rotatable knob 124 is free to rotate in a counterclockwise direction with the outward end 328 of the pawl member 324 pressing against and sliding over the inner teeth 320 during such rotation. However, rotation of the rotatable knob 124 in the opposite clockwise direction causes the short edge of the inner teeth 320 to press against the sidewall of the outward end 328 of the pawl member 324.

[0147] 31A-33B illustrate a mechanism 300c that may be included in the handle 100. The mechanism 300c is configured to control the axial displacement of the actuation members 40 and simultaneously disengage the actuation members 40 from the prosthetic valve 60. The mechanism 300c includes a central pull cable 48c that may be pulled in a proximal direction d1 by rotating a rotatable knob 122 (see FIG. 11 ) of the handle. The central pull cable 48c is coupled to a drag member 280c that is coupled to the actuation members 40 such that axial movement of the central pull cable 48c translates into axial displacement of the actuation members 40. The mechanism 300c includes a gear assembly 301c including an annular driver gear 344c that can be rotated by the rotatable knob 124 of the handle (see FIG. 11 ) and a driven pinion gear 356c engaged with the annular driver gear 344c. The actuating member 40 is coupled to the driven pinion gear 356c such that rotation of the annular driver gear 344c results in simultaneous rotation of the actuating member 40.

[0148] The multi-lumen shaft 22 includes a sleeve coupler 38 at its distal end (it should be noted that the multi-lumen shaft 22 is shown as transparent in FIG. 31A for purposes of illustration). A proximal portion of the sleeve member 34 of the actuation assembly 32 is coupled to the sleeve coupler 38. In the illustrated example, the sleeve coupler 38 has a cylindrical or disk shape. In other examples, the sleeve coupler 38 can have a variety of other shapes (e.g., a cube, a prism, etc.). The sleeve coupler 38 includes a number of openings 39 extending axially therethrough. An actuation member 40 extends through each sleeve member 34 and through each opening 39 into the multi-lumen shaft 22. The openings 39 are configured to allow the actuation member 40 to extend through the sleeve coupler 38 and to rotate freely relative to the sleeve coupler 38.

[0149] The drag member 280c is disposed within the multi-lumen shaft 22 (e.g., proximate the distal end of the multi-lumen shaft 22) and is axially movable within a distal portion of the multi-lumen shaft 22. In some examples, the drag member 280c can be disk-shaped. In some examples, the sleeve coupler 38 can prevent displacement of the drag member 280c from the distal end of the multi-lumen shaft 22.

[0150] The central pull cable 48c extends through a lumen of the multi-lumen shaft 22 (e.g., the central pull cable 48c can extend generally parallel to the actuation member 40c) and into a proximal portion of a cavity defined in the handle. A distal end portion of the central pull cable 48c is coupled to the drag member 280c such that axial movement of the central pull cable 48c can be translated into axial movement of the drag member 280c. The central pull cable 48c is configured to be pulled via rotation of a rotatable knob 122 (shown in FIG. 11 ) of the handle. For example, the mechanism previously shown in FIG. 18 can be modified such that the central pull cable 48c is attached to the expansion reel 270 and configured to wrap around the expansion reel 270, replacing the third actuation flexible portion 46c.

[0151] The central pull cable 48c can be in the form of any flexible member known in the art (e.g., cable, string, rope, etc.). When the central pull cable 48c is used in a displacement control mechanism, the actuation members 40 need not include an actuation member flexible portion, as previously described. Instead, the entire length of each actuation member 40 can be in the form of a single torque transmission portion.

[0152] The drag member 280c includes a plurality of drag member apertures 282c. Each actuating member 40 can extend through each aperture 282c. In some examples, each actuating member 40 can freely rotate about its axis of symmetry within each aperture 282c, but cannot translate axially therethrough. In some examples, each actuating member 40c includes a distal radial extension 284c (or stopper) positioned distally of the drag member and a proximal radial extension 286c (or stopper) positioned proximally of the drag member 280c. Each radial extension is attached to the actuating member 40 and extends radially beyond the outer circumferential edge of the respective aperture 282c.

[0153] In some examples, both radial extensions 284c and 286c are located near the proximal and distal surfaces of drag member 280c, thereby preventing axial movement of actuating member 40 within aperture 282c of drag member 280c. In some examples, the inner diameter of each aperture 282c is larger than the outer diameter of each actuating member 40 to an extent that allows rotational movement of actuating member 40 within aperture 282c.

[0154] Each driven pinion gear 356c is attached to a proximal portion of a corresponding actuation member 40 and engaged with an annular driver gear 344c. Thus, rotation of the annular driver gear 344c is translated into rotation of the driven pinion gear 356c, which is translated into rotation of the actuation member 40. FIGS. 31A and 33A show the driven pinion gear 356c directly meshed with the internal teeth of the annular driver gear 344c. In alternative implementations, the gear train can include any number of idler gears to translate rotation from the annular driver gear 344c to the driven pinion gear 356c, for example, as illustrated in FIGS. 29A and 29B.

[0155] In some examples, the axial length L70 (shown in FIG. 33B) of the annular driver gear 344c is greater than the axial length L80 (shown in FIG. 33B) of each driven pinion gear 356c, which allows each driven pinion gear 356c to remain engaged with the annular driver gear 344c as the driven pinion gear 356c and the annular driver gear 344c move axially relative to one another along the length L70.

[0156] If the actuating members 40 have the same length, the location of the proximal end of the actuating member 40 may be different when the actuating member 40 is positioned along a curved path (e.g., along a bend in the patient's vasculature). As illustrated by FIG. 32, the distal portion of the actuating member 40 defined between the drag member 280c and the prosthetic valve 60 has the same length, but the proximal end of the actuating member 40 is positioned at a different axial position.

[0157] The slidable movement of the driven pinion gear 356c within the annular driver gear 344c allows for free repositioning of a proximal portion of each actuating member 40 within the annular driver gear 344c, thereby compensating for different travel paths of the actuating members 40. The axial length L70 may be defined by a range of acceptable or expected positions of the driven pinion gear 356c, which may vary according to each patient's anatomy.

[0158] Once the prosthetic valve 60 is positioned at the desired implantation location, the central pull cable 48c is pulled proximally by rotating the rotatable knob 122. Because the central pull cable 48c is attached to the drag member 280c, the drag member 280c translates proximally, dragging all of the actuation members 40 through the distal radial extensions 284c. Pulling the actuation members 40 proximally results in the expansion of the prosthetic valve 60.

[0159] To release the actuating member 40 after expanding the valve, the annular driver gear 344c is rotated by rotating the rotatable knob 122. Because all of the driven pinion gears 356c are engaged with the annular driver gear 344c (either directly or indirectly via idler gears), the rotation of the annular driver gear 344c is translated into a simultaneous rotation of the driven pinion gears 356c, which is translated into a simultaneous rotation of the actuating member 40. The rotation of the actuating member 40 results in disengagement of the actuating member 40 from the respective rack members 68 of the valve rocker / actuator 62.

[0160] Additional details regarding the displacement control and release mechanisms are detailed in US Provisional Application No. 62 / 945,039, which is incorporated herein by reference.

[0161] 34A-34D illustrate a mechanism 300d that may be included in the handle 100. The mechanism 300d is configured to control the axial displacement of the actuation members 40 along the same length and simultaneously release the actuation members 40 from the prosthetic valve. The mechanism 300d includes a central pull cable 48d that may be pulled in a proximal direction d1 by rotating the rotatable knob 122. The central pull cable 48d pulls all of the actuation members 40, thereby expanding the valve. The mechanism 300d includes a gear assembly 301d that includes a distal driving spur gear 357d that is rotated by the rotatable knob 124, and a distal driven pinion gear 356d that is engaged with the distal driving spur gear 357d. The actuating member 40 is coupled to the distal driven pinion gear 356d such that rotation of the distal driven pinion gear 356d results in simultaneous rotation of the actuating member 40.

[0162] The driving spur gear 357d and the distal driven pinion gear 356d are disposed within the multi-lumen shaft 22 (it should be noted that the multi-lumen shaft 22 is shown as transparent for purposes of illustration). The multi-lumen shaft 22 can include a sleeve coupler 38 at its distal end, which can have the same characteristics as described with reference to FIGS. 31A-33B. A proximal portion of the sleeve member 34 of the actuation member 40 is attached to the sleeve coupler 38. The mechanism 300d further includes a drag member 280d, which is disposed within the multi-lumen shaft 22 and between the gears 357d, 356d and the sleeve coupler 38. The drag member 280d is axially movable within the distal portion of the multi-lumen shaft 22.

[0163] A central pull cable 48d extends through the multi-lumen shaft 22. The distal end of the central pull cable 48 is coupled to a driving spur gear 357d (instead of being fixedly attached to the drag member as described with respect to the pulling mechanism illustrated by FIGS. 31A and 31B ). The distal driving spur gear 357d is then coupled to the drag member 280d. Axial movement of the central pull cable 48d translates to axial movement of the drag member 280d within the distal portion of the multi-lumen shaft 22. Because the central pull cable 48d is not fixedly attached to the drag member 280d, the central pull cable 48d can be rotated about its central axis, which rotates the distal driving spur gear 357d.

[0164] The actuating members 40 are coupled to the drag member 280d such that the actuating members 40 can rotate about their respective axes but cannot move axially relative to the drag member 280d. For example, the actuating members 40 can extend through apertures in the drag member 280d and have proximal and distal radial projections. In addition, each actuating member 40 is attached at its distal portion to one of the distal driven pinion gears 356d (instead of a pinion gear in a handle as described with respect to the pull mechanism illustrated in FIGS. 31A and 31B).

[0165] In some cases, the central pull cable 48d can include a pull cable rigid portion and a pull cable soft portion. The pull cable rigid portion can be coupled at its proximal portion (i.e., a portion in the handle) to a proximal gear driven by a rotatable knob 124 (see FIGS. 29A-29B). In such cases, the pull cable rigid portion can be any flexible torque transmitting material or structure known in the art for transmitting torque applied from one end thereof to its opposite end. The pull cable rigid torque transmitting portion can extend between the driving spur gear 357d and at least the proximal gear driven by the rotatable knob 124. The pull cable soft portion can include any flexible soft portion in the form of a string, cable, wire, etc., that can be attached to the proximal end of the pull cable rigid portion, for example, via a coupler (not shown), and configured to wrap around a pulley and / or reel.

[0166] Although the actuating member 40 is illustrated in FIGS. 34A and 34B as extending along the entire length of the multi-lumen shaft 22, in other examples, the actuating member 40 can extend along a shorter length (e.g., between the distal driven pinion gear 356d and the distal threaded head 44 of the actuating member 40) and can be configured to function as a torque transmission member in these portions.

[0167] Once the prosthetic valve 60 is positioned at the desired implantation site, the central pull cable 48d is pulled proximally by rotating the rotatable knob 122 (shown in FIG. 11 ), pulling the drag member 280 and all of the actuation members 40, thereby expanding the prosthetic valve 60. Once the prosthetic valve 60 is expanded, the distal driving spur gear 357d is rotated by rotating the rotatable knob 124 (shown in FIG. 11 ). Because all of the distal driven pinion gears 356d are engaged with the driving spur gears 357d (directly or indirectly via an idler gear), the distal driven pinion gears 356d rotate simultaneously with the driving spur gears 357d, which results in disengagement of the actuation members 40 from the respective rack members 68 of the valve rocker / actuator 62.

[0168] Additional details regarding the pull mechanism illustrated in Figures 34A-34D can be found in US Application No. 62 / 945,039.

[0169] 35A-35B illustrate a mechanism 300e that may be included in the handle 100. The mechanism 300e is configured to control the axial displacement of the actuation member 40 and simultaneously disengage the actuation member 40 from the prosthetic valve 60. The mechanism 300e includes a first gear assembly 301e, which includes a primary gear 420e and a secondary gear 456e. The actuation member 40 is coupled to the secondary gear 456e such that rotation of the secondary gear 456e by the primary gear 420e results in rotation and axial translation of the actuation member. The mechanism 300e includes a second gear assembly 302e, which is coupled to the actuation member 40e and is capable of rotating the actuation member 40 and disengaging the actuation member 40 from the valve.

[0170] The primary gear 420e is provided with internal teeth and is coupled to and rotatable with the rotatable knob 122 (shown in FIG. 11 ). The secondary gear 456e is provided with external gear teeth that interconnect with the internal teeth of the primary gear 420e. Each secondary gear 456e is coupled (directly or indirectly) to a respective actuating member 40 and urges axial translation of the actuating member 40 in response to rotation of the primary gear 420e. In some examples, the axial length of the primary gear 420e is longer than the length of each secondary gear 456e, thereby allowing slidable movement of each secondary gear 456e along the length of the primary gear 420e. The secondary gears 456e are shown as directly meshed with the internal teeth of the primary gear 420e. In alternative implementations, the gear train can include any number of idler gears (such as those illustrated by idler gear 350 in Figures 29A and 29B) to convert rotation of the primary gear 420e to the secondary gear 456e.

[0171] In some examples, the first adaptors 464e are coupled to the respective secondary gears 456e. Each of the first adaptors 464e has a threaded bore. In the example illustrated by FIGS. 35A-35B, the proximal portion of each of the actuating members 40 has threads that match the internal threads in the threaded bore of each of the first adaptors 464e. The proximal portion of each of the actuating members 40 extends through the threaded bore of each of the first adaptors 464e such that rotation of the first adaptors 464e is translated into axial displacement of the actuating member 40 via rotation of the respective secondary gears 456e.

[0172] In some examples, the first adapter 464e includes a polygonal outer shape that matches the polygonal central bore of the respective secondary gear 456e such that when the first adapter 464e is disposed in the polygonal central bore, the first adapter 464e cannot rotate relative to the secondary gear 456e. Thus, when the secondary gear 456e rotates, the respective first adapter 464e rotates with the secondary gear 456e. In the implementation illustrated by FIG. 35A, the first adapter 464e is square shaped. In other implementations, the central bore of the secondary gear 465e can include a bore flat edge (such as, for example, the bore flat edge 362 shown in FIG. 29B) that matches a similar flat edge of the first adapter 464e.

[0173] In some examples, the first adapter 464e can further include a proximal first adapter base 466e configured to abut the secondary gear 456e. In some examples, the first adapter 464e can be otherwise shaped to be secured to the secondary gear 456e. In some examples, the first adapter 464e includes features other than shape matching to prevent its rotational movement relative to the secondary gear 456e. In some examples, the first adapter 464e can be secured to the secondary gear 456e, such as by gluing and welding, for example.

[0174] In some examples, the assembly 300e does not include the first adapter 464e, and the threaded proximal portion of each actuation member 40e is configured to match the internal threads of the central bore of the secondary gear 456e. In this case, rotation of the secondary gear 456e is directly translated into axial displacement of the actuation member 40e as the actuation member 40e extends through the central bore of the secondary gear 456e.

[0175] The second gear assembly 302e includes an annular driver gear 344e and a plurality of driven pinion gears 356e engaged with the annular driver gear 344e. Each driven pinion gear 356e is coupled (directly or indirectly) to a respective actuation member 40 and urges rotation of the actuation member 40 about a central axis of the actuation member 40 in response to rotation of the driven pinion gears 356e. The pinion gears 356e are shown as directly meshing with internal teeth of the annular driver gear 344e. In alternative implementations, the gear train can include any number of idler gears (such as those illustrated by the idler gears 350 described with reference to FIGS. 29A-29B) for translating rotation of the annular driver gear 344e to the pinion gears 356e.

[0176] In some examples, the axial length of the annular driver gear 344e can be longer than the length of each driven pinion gear 356e, thereby enabling slidable movement of each pinion gear 356e along the length of the annular driver gear 344e.

[0177] In some examples, the actuating members 40e may be fixedly attached to and extend through their respective actuating tubes, which may be fixedly attached to and extend through respective bores in the pinion gears 365e. In other examples, the assembly may not include actuating tubes, and each actuating member 40 may be fixedly attached directly to and extend through a bore in the respective pinion gear 356e.

[0178] When the prosthetic valve 60 is installed in the patient's body, the positions of the proximal ends of the actuating members 40 in the handle may be different even though the lengths of all the actuating members 40 are the same. The positions of the proximal ends may be different due to the curved path along the patient's vasculature. The slidable movement of the secondary gear 456e in the primary gear 420e and the slidable movement of the pinion gear 356e in the driver gear 344e allows free repositioning of the proximal portions of each actuating member 40e. The lengths of the primary gear 420e and the driver gear 344e may be defined by the range of acceptable or expected positions of the secondary gear 456e and the pinion gear 356e, respectively, which may vary according to each patient's anatomy.

[0179] Once the prosthetic valve 60 is positioned at the desired implantation location, the rotatable knob 122 is rotated, causing the primary gear 420e to rotate. Since all secondary gears 456e are engaged with the primary gears 420e (directly or indirectly via idler gears), the secondary gears 456e rotate simultaneously with their respective first adaptors 464e. Rotation of the first adaptors 464e results in axial translation of the actuating members 40. Rotation in a particular predefined direction results in axial displacement of the actuating members 40 in the proximal direction. The pinion gear 356e is allowed to slide axially within the driver gear 344e during axial displacement of the actuating members 40. Pulling all actuating members 40 simultaneously along a fixed distance results in uniform radial expansion of the valve 60. The mechanism 300e is capable of operating without an expansion reel.

[0180] When the prosthetic valve 60 is expanded, the driver gear 344e is rotated by manual rotation of the rotatable knob 124. Because all of the pinion gears 356e are engaged with the driver gears 344e, all of the pinion gears 356e rotate simultaneously with their respective actuation tubes 364e (or actuation members 40, if the actuation members 40 are directly attached to the pinion gears), which translates to disengagement of the actuation members 40 from the rack member 68 of the valve rocker / actuator.

[0181] 36A-36E illustrate an alternative mechanism 300f that may be included in the handle 100. The alternative mechanism 300f is configured to control the axial displacement of the actuation member 40 and simultaneously disengage the actuation member 40 from the prosthetic valve. The mechanism 300f includes a primary bevel gear 540f and a plurality of locking gears 570f that may be disposed in the handle. The primary bevel gear 540f has a distal surface 542f, the distal surface 542f being provided with teeth projecting in a distal direction. The locking gears 570f are engaged with the teeth. In some examples, the peripheral locking gears 570f are bevel gears designed to intersect with the primary bevel gear 540f. Each locking gear 570f includes a threaded bore 572f. A locking screw 574f is threadably engaged with the threaded bore 572f and configured to translate in a radial direction d3 when each locking gear 570f is rotated.

[0182] The mechanism 300f can include a core element 544f, which is concentric with the primary bevel gear 540f and disposed between the peripheral locking gears 570f. In some examples, the core element 544f is attached to the primary bevel gear 540f. The core element 544f includes a plurality of axial channels 546f. Each axial channel 546f is configured to allow free axial movement of a respective actuating member 40 (corresponding to the actuating member 40) extending therethrough. The core element 544f further includes an opening 548f, which extends radially from each axial channel 546f to an outer circumferential surface of the core element 544f. The opening 548f is aligned with a locking screw 574f located in the threaded bore 572f. The opening 548f is configured to allow passage of the locking screw 574f therethrough.

[0183] When the locking screw 574f is translated radially inward in direction d3, it passes through the opening 548f and bears against the respective actuating member 40. Movement of the locking screw 574f in direction d3 is stopped when the respective actuating member 40 bears against the inner wall of the respective axial channel 546f such that the actuating member 40 is locked in place and can no longer move axially relative to the core element 544f. In some examples, the locking screw 574f is provided with an atraumatic tip to avoid damaging the actuating member 40.

[0184] In some cases, the core element extension 550f extends radially from the core element 544f. The core element extension 550f is provided with a threaded extension bore 552f. A driving screw element 554f is threadedly engaged with the threaded extension bore 552f such that rotation of the driving screw element 554f translates into an axial displacement of the core element 544f, accompanied by translation of the actuating members 40 when the actuating members 40 are sandwiched within the axial channel 546f. Rotating the driving screw element 554f in a particular direction about its axis of symmetry translates into simultaneous displacement of all actuating members 40 in the proximal direction.

[0185] In some examples, the drive screw element 554f is operable by a rotatable knob 122 such that rotation of the rotatable knob 122 is translated into axial movement of the drive screw element 554f together with the core element extension 550f.

[0186] In some examples, the handle can include a rotatable locking knob that is rotatable by a user of the handle and operable to rotate the primary bevel gear 540f.

[0187] In some examples, the handle can include a release mechanism, which can be operated by a rotatable knob 124 (shown in FIG. 11).

[0188] The release mechanism includes an annular driver gear 344f and a plurality of driven pinion gears 356f engaged with the annular driver gear 344f. Each driven pinion gear 356f is coupled (directly or indirectly) to a respective actuation member 40 and urges rotation of the actuation member 40 about a central axis of the actuation member 40 in response to rotation of the driven pinion gears 356f. The pinion gears 356f may be directly meshed with internal teeth of the driver gear 344fe, as shown, or may be engaged with the driver gear 344f via any number of idler gears (such as illustrated by idler gear 350 shown in FIGS. 29A-B).

[0189] In some cases, the axial length of the annular driver gear 344f is longer than the length of each pinion gear 356f, thereby allowing slidable movement of each pinion gear 356f along the length of the annular driver gear 344f.

[0190] When a valve is releasably coupled to the actuation member 40 and installed in a patient's body, the position of the proximal end of the actuation member 40 in the handle may vary due to the curved path along the patient's vasculature. The slidable axial movement of the actuation member 40 in the axial channel 546f and the slidable axial movement of the pinion gear 356f in the annular gear 344f allows for free repositioning of the proximal portion of each actuation member 40. The length of the driver gear 344f is defined by the range of acceptable or expected positions of the pinion gear 356f and may vary according to each patient's anatomy.

[0191] Once the valve is positioned at the desired implantation site, the primary bevel gear 540f can be rotated by manually rotating the locking knob on the handle. Because all of the peripheral locking gears 570 are engaged with the primary bevel gears 540f, the peripheral locking gears 570 rotate simultaneously as well. Each rotation of the locking gears 570f results in a radially inward (i.e., in the direction d3) displacement of the locking screws 574f, pinching and locking the actuating member 40 against the core element 544f.

[0192] Once the actuating members 40 are locked in place, the driving screw element 554f can be rotated via the rotatable knob 122f, resulting in proximal axial displacement of the core element 544f along with the actuating members 40, the peripheral locking gear 570f, and the main bevel gear 540f. Pulling all of the actuating members 40 simultaneously along a fixed distance results in uniform radial expansion of the valve. The mechanism formed by the assembly 300f does not require an expansion reel.

[0193] When the prosthetic heart valve is expanded, manual rotation of the rotatable knob 124 rotates the driver gear 344f. Because all of the pinion gears 356f are engaged with the driver gear 344f, the pinion gears 356f rotate simultaneously with the driver gear 344f. The rotation of the pinion gears 356f then translates into disengagement of the actuation member 40 from the rack member 68 of the valve rocker / actuator.

[0194] Additional details regarding the mechanism illustrated in Figures 36A-36E are detailed in US patent application Ser. No. 62 / 945,039.

[0195] As mentioned above, all actuating members 40 are provided with equal length, but their proximal portions may end up in different axial positions due to the curved path of the delivery system, since all actuating members 40 are disposed at different locations within the lumen of the multi-lumen shaft 22. While some of the different examples described above are configured to overcome the differential paths of the actuating members 40 by mechanisms that allow axial displacement of the proximal portions of the actuating members 40 within the handle, other examples may provide solutions that depend on the structure of the multi-lumen shaft itself.

[0196] 37A-37C illustrate a twisted multi-lumen shaft 22g configured to overcome the differential path of an actuating member 40. The multi-lumen shaft 22g includes lumens 24a, 24b, and 24c. Actuating members 40a, 40b, and 40c extend through lumens 24a, 24b, and 24c, respectively. The number of lumens in the multi-lumen shaft 22g can be different than three and generally can match the number of actuating members.

[0197] The path of each lumen 24a, 24b, 24c is twisted along the length of the multi-lumen shaft 22g such that the actuating members 40a, 40b, 40c are at different positions relative to one another along the cross-section of the multi-lumen shaft. The relative positions of the lumens 24a, 24b, 24c and the actuating members 40a, 40b, 40c extending therethrough vary between the proximal and distal ends of the multi-lumen shaft. Advantageously, the twisted path of the lumens 24a, 24b, 24c results in a uniform length of the lumens even when the multi-lumen shaft 22g is bent along the patient's vasculature.

[0198] Additional details regarding twisted multi-lumen shafts are detailed in US patent application Ser. No. 62 / 945,039, which is incorporated herein by reference.

[0199] In some cases, when the prosthetic heart valve is delivered to the implantation site, the rockers / actuators 62 of the prosthetic valve 60 may be oriented such that they block or impede blood flow into the coronary ostia near the aortic annulus. In these cases, a mechanism that can enable rotation of the prosthetic valve 60 to reorient the rockers / actuators relative to the surrounding anatomical structures during the implantation procedure would be advantageous.

[0200] FIG. 38A illustrates a handle 100h including a distal portion 110h and a proximal portion 112h. The proximal portion 112h is axially movable and rotatable relative to the distal portion 110h. The proximal portion 112h has a receiver 541 (shown in FIG. 38B). In one example, the receiver 541 is fixedly mounted within the proximal handle portion 112 such that there is no relative movement between the receiver 541 and the proximal handle portion 112. In another example, the receiver 541 may be recessed or mounted within an adjustment knob (such as, for example, knob 128h) such that an operator of the handle can rotate the receiver 541 instead of the entire proximal handle portion 112.

[0201] As shown in FIG. 38B, the receiver 541 is configured to receive the non-circular casing 530. For example, the receiver 541 can include an inner bore or socket 542 that is sized and shaped to accommodate the non-circular casing 530 such that when the receiver 541 rotates in one direction, the casing 530 rotates in the same direction. The shaft assembly 11 (see FIG. 38A) can extend into the handle such that the casing 530 is disposed about a proximal portion of the multi-lumen shaft 22. In some examples, the proximal portion of the multi-lumen shaft 22 can be fixedly attached (e.g., by gluing, welding, etc.) to the casing 530 such that there is no relative movement between the multi-lumen shaft 22 and the casing 530.

[0202] FIG. 38C shows the prosthetic valve 60 positioned at the implantation site. The actuation member 40 extending through the multi-lumen shaft 22 is connected to the rocker / actuator 62. In this position, if the rocker / actuator 62 needs to be repositioned, the operator can rotate the receiver 541 (e.g., by rotating the proximal handle portion 112h or by rotating the adjustment knob 128h), which will rotate the casing 530 and the multi-lumen shaft 22. Since the actuation member 40 is locked to the prosthetic valve 60, the valve will rotate as well (e.g., in the direction c6). The valve 60 can be rotated while in a compressed state. If required, the valve 60 can be recompressed before rotation. FIG. 38D and FIG. 38E show schematic positions of the three rockers / actuators 62a, 62b, 62c of the valve 60 before and after rotation, respectively.

[0203] In some examples, a clicking mechanism 501 (shown in FIGS. 38F and 38G) may be provided to add clicking sounds to the rotational movement of the multi-lumen shaft 22. The clicking mechanism 501 may include a proximal protrusion 532 at the proximal end of the multi-lumen shaft 22. The proximal protrusion 532 may be in the form of a dimple. The clicking mechanism 501 may include a clicking member 520 positioned in an opposing relationship to the proximal end of the multi-lumen shaft 22. The end face 521 of the clicking member 520 may include a plurality of notches 522, which may be equally spaced in a circular pattern. Each notch 522 may selectively receive a protrusion 532, thereby producing a clicking sound when the multi-lumen shaft 22 rotates and when the protrusion 532 flexibly moves over a corresponding one of the series of notches 522.

[0204] While the prosthetic valve 60 is at the desired implantation location within the patient's body, the prosthetic valve 60 may be expanded by rotating the rotatable knobs 122 to simultaneously pull on the actuating members 40. Once the valve is expanded to a desired diameter, the actuating members 40 can be rotated about their axes to release their respective distal threaded heads 44 from the rack members 68 of the valve rocker / actuator 62, thereby allowing the delivery device to be removed from the patient's body.

[0205] During valve expansion, the actuation member 40 is normally tensioned. To initiate the release process, the operator can release the rotatable knob 122 to reduce tension, which may inhibit the opening torque required to release the actuation member 40 from the valve. One of the risks associated with such a procedure is potential entanglement of the flexible portion of the actuation member in the handle, which may result in the application of excessive pulling force. A further risk is that releasing too much tension from the actuation member may result in an actuation member that is too loose (i.e., not tensioned at all), which may result in free spinning of the actuation member. Pulling on the delivery device while the actuation member is still connected to the valve may displace the valve from its implanted position, since the operator may not have an indication of whether the actuation member has been detached from the valve.

[0206] 39A-39C illustrate a mechanism 700 that can allow safe retraction of the actuation member only when it is fully disengaged from the valve. The mechanism 700 includes an annular driver gear 702 with internal teeth, a first pinion gear 704 with external teeth, and a second pinion gear 706 with external teeth. Typically, there will be one pinion gear 704 for each actuation member 40 in the delivery device. For illustrative purposes, three actuation members 40 and three first pinion gears 704 are shown. The annular driver gear 702 is configured to drive the first pinion gear 704 and the second pinion gear 706, either directly or via an idler gear (e.g., idler gear 705). In one example, the annular driver gear 702 can be rotated by a rotatable knob 124 (which can operate similarly to the mechanism shown in FIGS. 29A and 29B).

[0207] Each of the first pinion gears 704 is coupled to a respective actuation member 40. For example, each of the actuation members 40 can extend through and be coupled to a respective actuation tube 364, as previously described. Each of the first pinion gears 704 can be disposed about and coupled to a respective actuation tube 364, thereby coupling the first pinion gears 704 to the actuation members 40.

[0208] The second pinion gear 706 is coupled to the pull plate 708. In one example, the second pinion gear 706 is disposed around and coupled to a proximal portion of a plate rod 710. The plate rod 710 extends through a slot 712 in the pull plate 708 and includes a thread 714. A nut 716 is threadably engaged with the plate rod 710 and positioned distally of the pull plate 708 such that rotation of the plate rod 710 translates into axial movement of the nut 716 toward the distal end 708a of the pull plate 708. In one example, a spring 718 can be disposed between the nut 716 and the distal end 708a of the pull plate 708 to allow for a gradual increase in the pulling force applied to the pull plate 708 by the nut 716.

[0209] The pull plate 708 is positioned distally of the actuation tube 364 and includes a slot 720 for passage of the portion of the actuation member 40 that extends distally from the actuation tube 364. The pull plate 708 is capable of sliding over the actuation member 40 without impeding movement of the actuation member 40. At the same time, the diameter of the slot 720 that receives the actuation member 40 is selected to be smaller than the diameter of the actuation tube 364 such that once the pull plate 708 contacts the actuation tube 364, further axial movement of the pull plate 708 in the proximal direction d1 will pull all of the actuation tube 364 and attached actuation member 40.

[0210] The rotatable knob 124 can be rotated to move the pull plate 708 axially. The pull plate 708 is initially spaced away from the actuation tube 364 to allow the pull plate 708 to move freely along the actuation members 40 without pulling on or impeding their motion, thereby allowing the actuation members 40 to initially rotate about their axes and be fully released from the valve. After the pull plate 708 contacts the actuation tube 364, additional rotation of the rotatable knob 124 will retract the actuation members 40.

[0211] Advantageously, mechanism 700 allows an operator to pull actuating member 40 from the prosthetic heart valve in a safe manner (i.e., only when actuating member 40 is fully released from the prosthetic heart valve). Both release of actuating member 40 from the valve and retraction of actuating member 40 can be performed in a sequential manner by operating a single rotatable knob (e.g., rotatable knob 124). Various parameters (e.g., idler gear thread pitch, design, number, etc.) can be adjusted to provide sufficient desired performance of the mechanism.

[0212] Mechanism 700 may be combined with any of the mechanisms of the handle described in this disclosure. For example, the portion of actuation member 40 extending proximally from actuation tube 364 may be coupled to a mechanism for second mechanism 1100 for expanding and compressing the valve described with reference to Figures 17-19. While actuation member 40 is engaged with the rocker / actuator of prosthetic valve 60, second mechanism 1100 may be operable to expand and / or compress the valve.

[0213] After securing the prosthetic heart valve in the patient's anatomy, the actuating member is disengaged from the valve's rocker / actuator so that the delivery device can be retracted from the patient's body. It is important to ensure that the actuating member is fully disengaged from the valve before initiating retraction of the delivery device. The implantation site is typically monitored under fluoroscopy or other x-ray imaging during the implantation procedure. The clinician can visually inspect the relatively opaque structures and determine if the actuating member has disengaged from the valve (e.g., by identifying a gap formed between them or by detecting spontaneous lateral movement of the distal end of the actuating member). However, this method is highly subjective and can be inaccurate. It would be advantageous if the delivery device could provide an objective indication when the actuating member is fully disengaged from the valve. Various mechanisms for detecting disengagement of the actuating member from the prosthetic heart valve's rocker / actuator are described below.

[0214] 40A and 40B illustrate an electrical mechanism 800a that can detect the release of the actuating member 40 from the rocker / actuator 62 of the prosthetic valve 60. The mechanism 800a is based on forming an electrical circuit that is closed when the actuating member 40 is engaged with the rocker / actuator 62 and is open when the actuating member 40 is released from the rocker / actuator 62.

[0215] In mechanism 800a, actuation member 40 includes an electrically conductive medium 802 and an electrically insulating material (or insulator) 804 disposed about conductive medium 802. Conductive medium 802 is connected to distal threaded head 44 of actuation member 40, which is also electrically conductive. Insulator 804 extends substantially along the length of actuation member 40, allowing distal threaded head 44 to remain electrically exposed.

[0216] 40A, a proximal portion of the actuating member 40 extends into the handle 100 and a distal threaded head 44 of the actuating member 40 is threadingly engaged with a threaded bore in a rack member 68 of the valve rocker / actuator 62. The conductive medium 802 is electrically coupled to a power source 806 inside the handle. A sleeve member 34 disposed about the actuating member 40 preferably bears against a housing member 64 of the rocker / actuator 62 when the distal threaded head 44 is engaged with the rack member 68, as previously described with reference to FIG. 6A. The sleeve member 34 may be made of a non-conductive material.

[0217] The conductive medium 802 is configured to complete an electrical circuit when the distal threaded head 44 is engaged with the rack member 68. Thus, by monitoring the current flowing through the electrical circuit, it is possible to determine whether the actuation member 40 is disengaged from the rack member. A current monitor (or current sensor) 808, which can be in the handle 100, monitors the current flowing through the electrical circuit. In some cases, the current monitor 808 is configured to provide an indication when the electrical circuit is open, which will correspond to the release of the distal threaded head 44 from the rack member 68. The indication can be visual (e.g., via a digital screen, LED light, etc.), audible, and / or tactile.

[0218] After securing the valve at the implantation site, a voltage may be delivered from the power source 806 to the conductive media 802. The voltage may be very low to minimize risk to the patient. The actuating member 40 may be disengaged from the rack member 68 by unscrewing the distal threaded bore 44 from the rack member 68. The current monitor 808 will detect a current when the distal threaded head 44 is threadably engaged with the bore of the rack member 68. When the actuating member 40 is rotated to a point where the distal threaded head 44 is fully disengaged from the rack member 68, as shown in FIG. 40B, no current will be detected by the current monitor 808.

[0219] The current monitor 808 can provide an indication to an operator of the handle 100 when the actuating member 40 is fully disengaged from the rack member 68. Preferably, the sleeve member 34 remains compressed against the housing member 64 of the rocker / actuator 62 until the actuating member 40 is fully disengaged from the rack member 68. When the current monitor 808 indicates that the actuating member 40 is fully disengaged from the rack member 68, the voltage delivered to the actuating member 40 is turned off, allowing the operator to safely retract both the actuating member 40 and the sleeve member 34.

[0220] For valves with multiple rockers / actuators and delivery devices with corresponding multiple actuation members, it may be sufficient to monitor the disengagement of only one of the actuation members from each rocker / actuator of the valve (e.g., in cases where the actuation members are rotated simultaneously to disengage the actuation members from the valve). In other cases, the disengagement of each actuation member from each rocker / actuator may be monitored as described above. The current signals from each monitoring may be processed separately or combined into a single output.

[0221] 41A and 41B illustrate an electrical rotation counting mechanism 800b capable of detecting the release of an actuation member 40 from a rocker / actuator 62 of a prosthetic valve 60. Although the electrical rotation counting mechanism 820 is described below with respect to a single actuation member 40, the electrical rotation counting mechanism 820 is not limited to a single actuation member 40 and may be implemented with respect to any number of actuation members 40 in a delivery device. The electrical rotation counting mechanism 800b is based on counting the number of rotations of the actuation member 40 via electrical means as the actuation member 40 is rotated to unscrew the distal threaded head 44 from the rack member 68 of the respective rocker / actuator 62 of the prosthetic valve 60.

[0222] The electrical rotation counting mechanism 800b includes a ring member 822 having a conductive portion 822a extending partially along the circumference of the ring and an insulated portion 822b extending along the remaining portion of the circumference. The ring member 822 is disposed in a recess 824 formed in an inner surface of a sleeve member 34 disposed about the actuating member 40. In the electrical rotation counting mechanism 800b, the sleeve member 34 is made of a non-conductive or electrically insulating material.

[0223] The actuation member 40 includes a conductive medium 830 that is connected at one end to the distal threaded head 44 and at another end to a power source 834. The power source 834 can be in the handle 100. A conductive arm 826 extends laterally from the conductive member 830 at an axial location that is aligned with the location of the ring member 822 and is proximal to the distal threaded head 44 of the actuation member 40. The conductive arm 826 is biased (e.g., by a spring) against an inner surface 828 of the ring member 822. The conductive medium 830 is covered by a non-conductive layer 832 except for the area where the conductive medium 830 is connected to the conductive arm 826. Additionally, the conductive arm 826 is electrically exposed.

[0224] The conductive arm 826 rotates with the actuating member 40 while the actuating member 40 is rotated about its central axis to unscrew the distal threaded head 44 from the rack member 68 of the valve rocker / actuator 62. As the actuating member 40 rotates, the conductive arm 826 is always pressed against the inner surface of the ring member 822, so that electrical current is transferred to the conductive portion 822a of the ring member 822 during a portion of the rotational cycle when the conductive arm 826 is in contact with the conductive portion 822a. This results in a "pulsed" electrical current being generated during each rotational cycle of the actuating member 40.

[0225] Multiple rotational cycles of the actuating member 40 will result in a like number of electrical "pulses" conducted by the conductive portion 822a of the ring member 822, which may be transmitted to a counting mechanism in the handle. In one implementation, the number of rotations required to release the actuating member 40 from the rack member 68 is known (e.g., the number of rotations may correspond to the number of threads on the distal threaded head 44). Exceeding this required number of rotations may indicate release of the actuating member 40 from the rack member 68.

[0226] In one example, a counter 834 in the handle can detect and count the number of electrical pulses and can provide an indication when the number of electrical pulses exceeds a predetermined threshold that correlates to the number of rotations required to release the actuating member 40 from the rack member 68. The indication can be visual (e.g., via a digital screen, LED lights, etc.), audible, and / or tactile.

[0227] 42 illustrates a magnetic rotation counting mechanism 800c capable of detecting the release of an actuation member 40 from a rocker / actuator 62 of a prosthetic valve 60. Although the magnetic rotation counting mechanism 800c is described below with respect to a single actuation member 40, the magnetic rotation counting mechanism 800c is not limited to a single actuation member 40 and may be implemented with respect to any number of actuation members 40 in a delivery device. The magnetic rotation counting mechanism 800c is based on counting the number of rotations of the actuation member 40 via magnetic means as the actuation member 40 is rotated to unscrew the distal threaded head 44 from the rack member 68 of the respective rocker / actuator 62 of the prosthetic heart valve.

[0228] The magnetic rotation counting mechanism 800c can include a magnetic ring 842 that is attached to the actuating member 40 at an axial location proximal to the distal threaded head 44 of the actuating member 40. The magnetic ring 842 includes at least two regions provided with opposite polarities (S and N). Alternatively, at least two separate magnetic elements with opposite polarities can be substituted for the magnetic ring. The magnetic ring 842 (or magnetic element) rotates with the actuating member 40.

[0229] The magnetic rotation counting mechanism 800c includes a magnetic sensor 844 that is axially aligned with a magnetic ring 842 (or magnetic element). The magnetic sensor 844 may be attached to (e.g., on an outer surface of) a sleeve member 34 that is disposed around the actuating member 40 of the actuation assembly 32. The magnetic sensor 844 may be in communication with a signal counter 846 in the handle 100. The magnetic sensor 844 senses the rotation of the actuating member 40 (e.g., due to changes in polarity at different phases of a rotation cycle) and generates a corresponding signal that is received by the signal counter 846.

[0230] In one implementation, the number of rotations required to release the actuating member 40 from the rack member 68 of each rocker / actuator 62 is known, and the actuating member 40 is considered to be released when the number of rotations of the actuating member 40 exceeds the number of required rotations. In one example, a counter 846 counts the number of signals generated by the magnetic sensor 844 (which indicates the number of complete rotations of the actuating member).

[0231] In one example, the counter 846 is configured to provide an indication when the number of complete rotations of the actuating member 40 exceeds the number of rotations required to release the actuating member 40 from the rack member 68. The indication can be visual (e.g., via a digital screen, LED light, etc.), audible, and / or tactile.

[0232] 43 illustrates an optical rotation counting mechanism 800d configured to detect the release of an actuation member 40 from a rocker / actuator 62 of a prosthetic valve 60. Although the optical rotation counting mechanism 800d is described below with respect to a single actuation member 40, the optical rotation counting mechanism 800d is not limited to a single actuation member 40 and may be implemented with respect to any number of actuation members 40 in a delivery device. The optical rotation counting mechanism 800d is based on counting the number of rotations of the actuation member 40 via optical means as the actuation member 40 is rotated to unscrew the distal threaded head 44 from the rack member 68 of the respective rocker / actuator 62 of the prosthetic heart valve.

[0233] The optical rotation counting mechanism 800d may include a housing 862 that is circumferentially disposed about the actuating member 40 at an axial location proximal to the distal threaded head 44 of the actuating member 40. The housing 862 may be fixed to a sleeve member 34 that is disposed about the actuating member 40 such that the housing 862 can be stationary while the actuating member 40 is rotated. An inner chamber 864 is defined between the housing 862 and the actuating member 40. Preferably, the inner chamber 864 is sealed (e.g., by providing a seal member 866 in the interface between the housing 862 and the actuating member 40) to prevent blood flow into the inner chamber 864.

[0234] The optical rotation counting mechanism 800d includes a light absorber 868 that is coupled to a surface 863 of the actuating member 40 exposed to the inner chamber 864. The light absorber 868 is coupled to a section of the surface 863 and does not extend around the periphery of the actuating member 40. The light absorber 868 can be in the form of a dark marking or other light absorbing structure that can be coupled to the actuating member 40.

[0235] The optical rotation counting mechanism 800d includes two optical cores 870, 872 that extend into the inner chamber 864. The optical cores 870, 872 can extend from the handle 100 into the inner chamber 864. In one example, the optical cores 870, 872 can be provided as separate optical fibers. In another example, a single optical fiber with two cores can provide the optical cores 870, 872. The optical core 870 can be connected to a light source 874 (which can be within the handle 100 or otherwise coupled to the handle 100), and the optical fiber 870 can be connected to a light detector 876 (which can be within the handle 100 or otherwise coupled to the handle 100).

[0236] Optical core 870 is positioned to direct light towards surface 863 of actuating member 40 within inner chamber 864. For example, the end of optical core 870 inside inner chamber 864 may be oriented transversely (or radially) relative to the longitudinal axis of actuating member 40. Optical core 872 is positioned to detect light returned from surface 863 of actuating member exposed to inner chamber 864. Optical core 872 can have the same orientation as described with respect to optical core 870.

[0237] As the actuating member 40 is rotated to unscrew the distal threaded head 44 from the rack member 68, the optical core 870 emits light in a direction towards the rotational surface 863 of the actuating member 40, and the optical core 872 receives light returned from the rotational surface 863 of the actuating member 40. During each rotational cycle of the actuating member 40, at a particular rotational angle of the actuating member 40, the light emitted from the optical core 870 will impinge on the light absorber 868, and the intensity of the light returned from the light absorber 868 to the optical core 872 will be correspondingly reduced. By monitoring the change in the intensity of the light returned to the optical core 872 and detected at the photodetector 876, the number of rotations of the actuating member 40 can be determined.

[0238] In one implementation, the circuitry of the photodetector 876 is configured to count the number of reduced light intensity phases sensed by the optical core 872, which indicates the number of complete rotations of the actuating member 40. In one example, the number of rotations required to release the actuating member 40 from the rack member 68 is known (e.g., based on the number of threads in the distal threaded head 44), and the circuitry of the photodetector 876 is configured to generate an output when the count of reduced light intensity phases sensed from the optical core 872 exceeds the number of rotations required.

[0239] In one example, the photodetector 876 circuit is configured to provide an indication when the number of complete rotations of the actuating member 40 exceeds a predetermined number of rotations required to release the actuating member 40 from the rack member 68. The indication can be visual (e.g., via a digital screen, LED light, etc.), audible, and / or tactile.

[0240] During the valve implantation procedure, a distal gap may form between the nosecone and the distal end of the prosthetic heart valve after retracting the outer shaft from the prosthetic heart valve at the implantation site. This may be particularly true for prosthetic heart valves having a relatively large diameter, where the prosthetic heart valve assumes a pre-expanded or compressed diameter that is somewhat larger than the diameter of the distal capsule after the outer shaft is retracted. The distal gap creates a discontinuity in the delivery device that may make it difficult to advance the prosthetic heart valve distally if repositioning of the prosthetic heart valve is required. In this case, it may be desirable to close or minimize the distal gap before attempting to reposition the valve.

[0241] After securing the prosthetic heart valve to the native anatomy, the delivery device is released from the prosthetic heart valve so that the delivery device can be withdrawn from the patient's body. If the nosecone is distal to the prosthetic heart valve after releasing the delivery device from the prosthetic heart valve, the nosecone will have to be withdrawn through the valve in order to withdraw the delivery device from the patient's body. While the nosecone is being pulled through the valve, the proximal edge of the nosecone may contact an area of ​​the expanded prosthetic heart valve (including the distal lip of the prosthetic heart valve), resulting in a risk of valve migration as a result of the pulling force exerted on the valve by the nosecone. In this case, it may be desirable to move the nosecone proximal to the prosthetic heart valve before releasing the delivery device from the valve.

[0242] FIG. 44 illustrates a fourth mechanism 1300 (i.e., a shaft displacement mechanism) that may be controlled by the slidable knob 136. The fourth mechanism 1300 is configured to displace the nosecone shaft 56 relative to the handle 100. The mechanism 1300 includes a slider inner body portion 137 that is positioned within a proximal portion of the cavity 107 of the handle 100. The mechanism 1300 includes a slot 140 formed in the housing member 112. The slidable knob 136 is positioned to slide along the slot 140 and is coupled to the slider inner body portion 137. Movement of the slidable knob 136 along the slot 140 results in displacement of the slider inner body portion 137 in the axial direction of the handle.

[0243] The nosecone shaft 56 extends proximally from the multi-lumen shaft 22 and is coupled to the slider inner body 137 (e.g., by engaging a recess in the slider inner body 137) such that axial movement of the slider inner body 137 produces axial movement of the nosecone shaft 56. In one example, movement of the slidable knob 136 in the slot 140 in a distal direction advances the nosecone shaft 56 distally, and movement of the knob 136 in a proximal direction retracts the nosecone shaft 56 proximally. The nosecone shaft 56 can be advanced or retracted to adjust the position of the nosecone at the distal end of the nosecone shaft 56 relative to other structures in the delivery assembly (e.g., the prosthetic valve 60 or the outer shaft 14, etc.).

[0244] The knob rocker 138 is an example of a safety knob, and the knob rocker 138 may be coupled to the slidable knob 136. The knob rocker 138 may be adjustable to allow or prevent axial movement of the slidable knob 136 within the slot 140. The knob rocker 138 may be, for example, a screw. The knob rocker 138 may be rotatable in a first direction and may engage the slidable knob 136, thereby applying a frictional force to the slidable knob 136, which prevents axial movement of the slidable knob 136. The knob rocker 138 may be rotatable in a second direction opposite the first direction and may radially space the knob rocker 138 away from the slidable knob 136, thereby allowing the slidable knob 136 to slide freely axially along the slot 140.

[0245] 45A-C show different stages of steering the nosecone 50 via axial displacement of the nosecone shaft 56. FIG. 45A illustrates two optional positions of the nosecone 50 relative to the prosthetic valve 60 and the multi-lumen shaft 22 of the delivery device, where the nosecone 50 can be radially offset away from the centerline of the prosthetic valve 60 from a first location of the nosecone 50 and the nosecone shaft 56 to a second location shown in dashed lines of the nosecone 50' and the nosecone shaft 56'. As shown in FIG. 45B, for example, retraction of the nosecone 50' in the proximal direction during retrieval of the delivery device after the prosthetic valve 60 is in place can result in contact between the nosecone 50' and the distal edge of the valve. FIG. 45B shows a gap g1 that can be formed between the prosthetic valve 60 and the nosecone 50. FIG. 45C shows the nosecone 50 being pulled in a proximal direction d1 (e.g., by displacing the nosecone shaft 56 in a proximally oriented direction d1 using the slidable knob 136) to minimize the gap g1.

[0246] 46A-46E show steps in a method for controlling the position of the nosecone 50 to ensure its safe retrieval after the prosthetic valve 60 has been secured at the implantation site. FIG. 46A shows a first step in the method, in which the nosecone 50 is displaced distally relative to the expanded prosthetic valve 60 while the prosthetic heart valve is still attached to the delivery device via the actuation assembly of the delivery device. FIG. 46B shows a second step in the method, in which the nosecone 50 is pulled in the proximal direction d1 (e.g., by displacing the nosecone shaft 56 using the slidable knob 136). At this step, the prosthetic valve 60 (which is, for example, expanded against the aortic annulus) is still attached to the delivery device via the actuation assembly. Using the slidable knob 136, the nose cone 50 can be pulled back proximally through the expanded prosthetic valve 60, as indicated by arrow 135, until the nose cone 50 is positioned proximal to the prosthetic valve 60 (e.g., until the nose cone is positioned between the proximal edge of the prosthetic valve 60 and the distal edge of the multi-lumen shaft 22), as illustrated in FIG. 46C. FIG. 46C shows a third stage of the method, in which the prosthetic valve 60 has been disengaged from the delivery device. Because the nose cone 50 is now proximal to the prosthetic valve 60, it can be safely withdrawn along with the entire delivery device.

[0247] A fourth step of the method can include using each of the slidable knob 136 and the rotatable knob 120 (see FIG. 11 ) to close the gap between the nosecone 50 and the distal end of the outer shaft 14. For example, as shown in FIG. 46D , the slidable knob 136 can be operated to displace the nosecone 50 in a distally oriented direction, as indicated by arrow 139, such that the nosecone 50 is distal to the actuation assembly 32. As shown in FIG. 46E , the rotatable knob 120 can be operated to displace the outer shaft 14 in a distally oriented direction, as indicated by arrow 141, extending the outer shaft 14 above the actuation assembly 32 and the nosecone shaft 56 to close the gap between the nosecone 50 and the distal end of the outer shaft 14. If needed, the slidable knob 136 can be actuated to pull the nosecone 50 in a proximally oriented direction, as indicated by arrow 143, compressing the distal end of the outer shaft 14. Closing or minimizing any gap between the nosecone 50 and the distal end of the outer shaft 14 can allow for safer and easier retrieval of the delivery device from the patient's body.

[0248] Further details regarding how nosecone displacement may be used can be found in US Pat. No. 5,399,633.

[0249] 47A-47C illustrate another exemplary handle 100a including a distal portion 110a and a proximal portion 112a that are telescopically movable relative to one another along the longitudinal axis 101a of the handle. The distal portion 110a and the proximal portion 112a define a cavity for containing the components of the handle. The handle 100a includes a rotatable knob 120a, a rotatable knob 122a, a rotatable knob 124a, and a fourth knob 126a, which are illustrated as rotatable knobs. The handle 100a can further include a safety knob 130a and a knob 430a. The knobs 122a, 124a, 126a, 130a, 430a can have the corresponding functionality described with respect to the knobs 122, 124, 126, 130, 430.

[0250] The proximal portion of the shaft assembly 11 extends into the cavity of the handle. The shaft assembly 11 illustrated by FIGS. 47A-47C includes the outer shaft 14, the commander shaft 30, and the multi-lumen shaft 22 (as previously shown in FIG. 9A). The handle 110a includes a mechanism 1000a for retracting the outer shaft 14 and the commander shaft 30. The mechanism 1000a includes a rotatable knob 120a configured to retract the outer shaft 14. The mechanism 1000a further includes the proximal ends of the outer shaft 14 and the commander shaft 30, which are coupled to the distal portion 110a such that telescopic movement of the portions 110a, 112a can retract both the outer shaft 14 and the commander shaft 30.

[0251] In one example, the proximal portion 112a may be held relatively stationary while the distal portion 110a is moved toward the proximal portion 112a, which will retract both the outer shaft 14 and the commander shaft 30. For safety purposes, a removable cover 114a may be disposed between the distal portion 110a and the proximal portion 112a to prevent telescopic movement of the portions 110a, 112a until telescopic movement is desired. This may prevent unintentional retraction of the commander shaft 30. When it is desired to retract the commander shaft 30 (e.g., after an initial retraction of the outer shaft 14), the removable cover 114a may be removed, as shown in FIG. 47C.

[0252] Thus, the rotatable knob 120 and the telescopically movable portions 110a, 112a of the handle form a two-stage shaft retraction mechanism 1000a configured to retract the outer shaft 14 and the commander shaft 30. In a first stage, the outer shaft 14 can be retracted by rotating the rotatable knob 120, while the commander shaft 30 (covering the actuation assembly 32) is kept in its position to prevent both axial displacement and undesired radial expansion of the valve in this stage (as shown in FIG. 9C). In a second stage, the outer shaft 14 is further retracted together with the commander shaft 30 by telescopically sliding the portions 110a, 112a of the handle 100a towards each other.

[0253] The handle 100a may generally be used as follows: The distal end of the delivery device 12 (with the prosthetic heart valve encapsulated therein) is inserted into the patient's body and advanced through the patient's vascular system. If it is required to navigate the delivery device 12 through the patient's vascular system, the fourth knob 126a may be operated. Once the prosthetic heart valve is positioned at the desired implantation site, the rotatable knob 120a is rotated to retract the outer shaft 14 and the distal capsule attached to the outer shaft 14, exposing the prosthetic heart valve. The commander shaft 30 retains its position in this state and is compressed against the prosthetic heart valve, preventing proximal displacement of the prosthetic heart valve. Once the outer shaft 14 has been sufficiently retracted, a relative sliding movement between the distal portion 110a of the handle 100a is used to retract both the outer shaft 14 and the commander shaft 30, exposing the actuation assembly 32 of the delivery device 12.

[0254] Additional actions by the handle 100a can include operating the rotatable knob 122a to expand the prosthetic heart valve (e.g., the rotatable knob 122a can be operated to simultaneously pull the actuation member 40 as previously described) and operating the rotatable knob 124a to release the actuation members of the delivery device 12 from the prosthetic heart valve (e.g., the rotatable knob 124a can be operated to simultaneously rotate the actuation members 40, thereby unscrewing the threaded heads 44 of the actuation members 40 from the respective rack members 68 of the rocker / actuator 62 of the prosthetic heart valve as previously described). The delivery device 12 can be withdrawn from the patient's body after releasing the actuation members from the valve.

[0255] FIG. 48 illustrates another exemplary handle 100b, which includes a distal end 102b, a proximal end 104b, and a longitudinal axis 101b that extends from the distal end 102b to the proximal end 104b and defines an axial direction of the handle. The handle 100b includes housing members 110b, 112b, 113b that are coupled together and extend along the longitudinal axis 101b. The housing members 110b, 112b, 113b define a cavity for containing the components of the handle. The handle 100b includes a rotatable knob 120b, a rotatable knob 122b, a rotatable knob 124b, and a fourth knob 126b, which are illustrated as rotatable knobs. The handle 100b can further include a knob 430. Knobs 122b, 124b, 126b, and 430b may have the corresponding functionality described with respect to knobs 122, 124, 126, and 430.

[0256] The proximal portion of the shaft assembly 11 extends into the cavity of the handle. The shaft assembly 11 illustrated by FIG. 48 includes the outer shaft 14, the commander shaft 30, and the multi-lumen shaft 22 (as previously shown in FIG. 9A). FIGS. 49A-49D illustrate a two-stage shaft retraction mechanism 1000b that can be used to retract the outer shaft 14 and the commander shaft 30. In the example illustrated by FIGS. 49A-49D, a first axially movable component 148b is coupled to the proximal end of the outer shaft 14, and a second axially movable component 149b is coupled to the proximal end of the commander shaft 30. The first axially movable component 148b and the second axially movable component 149b are movable along an inner track 144b formed in the handle 100b.

[0257] In one example, the first axially movable component 148b can be an internal nut movable along the inner track 144b upon rotation of the rotatable knob 120b (shown in FIG. 48). The second axially movable component 149b is positioned proximal to the first axially movable component 148b and is slidable within the inner track 144b. In some cases, the mechanism can include a stopping feature 128b positioned to prevent distal displacement of the second axially movable component 149b beyond a predetermined position. In one example, the stopping feature 128b can be a rod disposed between the second axially movable component 149b and the distal end 102b of the handle.

[0258] Because the outer shaft 14 is attached to the first axially movable component 148b, proximal displacement of the first axially movable component 148b causes the outer shaft 14 to retract. The first axially movable component 148b and the second axially movable component 149b are configured to contact each other during proximal displacement of the first axially movable component 148b. For example, an inner surface of the first axially movable component 148b can be shaped to contact an adjacent outer surface of the second axially movable component 149b when the first and second axially movable components 148b, 149b meet each other along the inner track 144b.

[0259] FIG. 49B shows that the first axially movable component 148b has moved away from the handle distal surface 102b but has not yet reached the second axially movable component 149b. FIG. 49C shows the first axially movable component 148b during a first contact with the second axially movable component 149b. Further movement of the first axially movable component 148b after this first contact results in both the first and second axially movable components 148b, 149b moving in the same proximally oriented direction d1, as shown in FIG. 49D. Because the commander shaft 30 is attached to the second axially movable component 149b, the proximal displacement of the second axially movable component 149b retracts the commander shaft 30 (i.e., pulls the commander shaft 30 in the proximal direction).

[0260] Rotation of a single knob (e.g., rotatable knob 120b) retracts the outer shaft 14 and exposes the valve, while the commander shaft 30 (covering the actuation assembly 32) is held in position to prevent both axial displacement and undesired radial expansion of the valve. Further successive rotations of the same knob retract the commander shaft 30 and expose the actuation assembly 32. The distance that the first axially movable component 148b travels before reaching and contacting the second axially movable component 149b can be designed to match the amount the outer shaft 14 must be retracted to expose the valve. That distance can be defined, for example, by the stopping feature 128.

[0261] The two-stage shaft retraction mechanism described with reference to Figures 47A-47C requires the operator to first rotate a knob on the handle to retract the outer shaft 14 and then slide the handle portions together in a telescopic fashion to achieve two-stage shaft retraction. The two-stage shaft retraction mechanism described with reference to Figures 49A-49D achieves two-stage retraction in a sequential manner with a single knob.

[0262] Additional Examples of the Disclosed Technology

[0263] In view of the above-described implementations of the disclosed subject matter, the present application discloses additional examples, which are listed below. It should be noted that one feature of an example alone, or two or more features of an example in combination, and optionally two or more features of an example in combination with one or more features of one or more additional examples, are also additional examples that fall within the disclosure of the present application.

[0264] Example 1: A delivery device for implanting a prosthetic heart valve includes one or more shafts and a handle coupled to the one or more shafts, the handle including one or more knobs, one or more adjustment mechanisms, and / or one or more control mechanisms, the knobs configured to actuate the one or more adjustment mechanisms and / or the one or more control mechanisms, the one or more adjustment mechanisms configured to move the shafts relative to each other and / or relative to the handle, and the one or more control mechanisms configured to limit the direction of movement and / or force applied to the one or more shafts.

[0265] Example 2: A delivery assembly includes a delivery device as described in any of the examples herein, especially example 1, and a prosthetic heart valve coupled to the delivery device.

[0266] Example 3: A delivery assembly as described in any of the examples herein, especially example 2, wherein the prosthetic heart valve is a mechanically expandable prosthetic heart valve.

[0267] Example 4: A delivery assembly as described in any of the examples herein, especially Example 3, wherein the mechanically expandable prosthetic heart valve comprises a plurality of struts pivotally connected together.

[0268] Example 5: A delivery device as described in any one of the examples herein, particularly any one of Examples 1 to 4, wherein the one or more knobs of the handle include three to four rotatable knobs.

[0269] Example 6: A delivery device as described in any one of the examples herein, especially any one of Examples 1 to 5, wherein the one or more knobs of the handle include exactly three rotatable knobs.

[0270] Example 7: A delivery device as described in any one of the examples herein, especially any one of Examples 1 to 5, wherein the one or more knobs of the handle include exactly four rotatable knobs.

[0271] Example 8: A method of implanting a prosthetic heart valve includes rotating a first knob on a handle of a delivery device to retract a first shaft of the delivery device relative to the prosthetic heart valve; rotating a second knob on the handle to adjust radial expansion of the prosthetic heart valve; and rotating a third knob on the handle to release the prosthetic heart valve from the delivery device.

[0272] Example 9: The method of any of the examples herein, especially Example 8, further comprising rotating a slidable knob on the handle to adjust the curvature of the first shaft.

[0273] Example 10: An assembly for implanting a prosthetic heart valve includes a prosthetic heart valve configured to be moved from a compressed state to an expanded state and from the expanded state to a compressed state. The assembly further includes a delivery device including one or more shafts and a handle, the prosthetic heart valve releasably coupled to at least one of the one or more shafts of the delivery device, and the handle configured to position the prosthetic heart valve and to adjust the prosthetic heart valve from the compressed state to the expanded state and from the expanded state to the compressed state.

[0274] Example 11: A delivery device for implanting a prosthetic heart valve includes a first shaft including a distal end portion and a proximal end portion, the distal end portion of the first shaft including a capsule, the capsule configured to receive the prosthetic heart valve in a radially compressed state; a second shaft including a distal end portion and a proximal end portion, the second shaft extending through the first shaft, the distal end portion of the second shaft configured to contact the prosthetic heart valve; and a third shaft including a distal end portion and a proximal end portion, the third shaft extending through the second shaft, the distal end portion of the second shaft configured to be releasably coupled to the prosthetic heart valve. a third shaft, wherein the first shaft, the second shaft, and the third shaft are axially movable relative to one another; and a handle including a distal portion and a proximal portion, wherein the proximal end portion of the first shaft and the proximal end portion of the second shaft are coupled to the distal portion of the handle and the proximal end portion of the third shaft is coupled to the proximal portion of the handle, the handle configured for a first mode of operation and a second mode of operation, wherein in the first mode of operation the first shaft is axially movable relative to the second shaft and the third shaft, and wherein in the second mode of operation the first shaft and the second shaft are axially movable relative to the third shaft.

[0275] Example 12: A delivery device as described in any of the examples herein, especially Example 11, wherein the handle includes a locking member, and the locking member is configured to restrict the handle from being moved from the first operating mode to the second operating mode.

[0276] Example 13: A delivery device as described in any of the examples herein, especially Example 12, wherein the locking member comprises a cover disposed between the distal portion of the handle and the proximal portion of the handle.

[0277] Example 14: A delivery device as described in any of the Examples herein, particularly any one of Examples 11 to 13, wherein the handle further includes a first knob rotatably coupled to a distal portion of the handle, and the handle is configured such that rotating the first knob relative to the distal portion of the handle results in the first shaft moving axially relative to the second shaft and the third shaft.

[0278] Example 15: A delivery device as described in any example herein, particularly any one of Examples 11 to 14, wherein in the second mode of operation, the handle is configured such that a distal portion of the handle and a proximal portion of the handle can move axially relative to one another.

[0279] Example 16: A delivery device as described in any example herein, particularly any one of Examples 11 to 15, wherein in the second mode of operation, the handle is configured such that a distal portion of the handle and a proximal portion of the handle can move in a telescopic manner relative to one another.

[0280] Example 17: A delivery device as described in any of the examples herein, especially any one of Examples 11 to 16, wherein the handle further comprises a force balancing assembly.

[0281] Example 18: A delivery device as described in any of the examples herein, especially example 17, wherein the force balancing assembly includes one or more pulleys.

[0282] Example 19: A delivery device as described in any of the examples herein, especially any one of Examples 11 to 18, wherein the handle further comprises a displacement control mechanism.

[0283] Example 20: A delivery device as described in any example herein, especially example 19, wherein the displacement control mechanism includes a plurality of gears.

[0284] Example 21: A delivery device as described in any of the examples herein, particularly any one of Examples 11 to 18, wherein the delivery device further comprises a displacement control mechanism.

[0285] Example 22: A delivery device as described in any example herein, especially example 21, wherein the displacement control mechanism includes a plurality of gears.

[0286] Example 23: A delivery device as described in any example herein, particularly any one of Examples 11 to 22, wherein the handle further includes a second knob rotatably coupled to a proximal portion of the handle, and the handle is configured such that rotating the second knob in a first direction relative to the proximal portion of the handle results in radial expansion of the prosthetic heart valve, and the handle is configured such that rotating the second knob in a second direction relative to the proximal portion of the handle results in radial compression of the prosthetic heart valve.

[0287] Example 24: A delivery device for implanting a prosthetic heart valve includes a first shaft including a distal end portion and a proximal end portion, the distal end portion of the first shaft including a capsule, the capsule configured to receive the prosthetic heart valve in a radially compressed state; a second shaft including a distal end portion and a proximal end portion, the second shaft extending through the first shaft, the distal end portion of the second shaft configured to contact the prosthetic heart valve; and a third shaft including a distal end portion and a proximal end portion, the third shaft extending through the second shaft, the distal end portion of the second shaft configured to be releasably coupled to the prosthetic heart valve; a handle including a main portion and a first knob, wherein proximal end portions of the first shaft, the second shaft, and the third shaft are coupled to the main portion of the handle, the first knob being rotatably coupled to the main portion, the handle being configured such that rotating the first knob in a first direction relative to the main portion from a first rotational position to a second rotational position results in axial movement of the first shaft relative to the second shaft and the third shaft, and the handle being configured such that rotating the first knob in the first direction relative to the main portion from the second rotational position to the third rotational position results in axial movement of the first shaft and the second shaft relative to the third shaft.

[0288] Example 25: A delivery device as described in any of the examples herein, especially Example 24, wherein the handle further includes a force balancing assembly, the force balancing assembly being disposed within the main portion and coupled to the second shaft.

[0289] Example 26: A delivery device as described in any example herein, especially example 25, wherein the force balancing assembly comprises one or more pulleys.

[0290] Example 27: A delivery device as described in any of the examples herein, particularly any one of Examples 24 to 26, wherein the handle further includes a displacement control mechanism, the displacement control mechanism being disposed within the main portion and coupled to the second shaft.

[0291] Example 28: A delivery device as described in any example herein, especially example 27, wherein the displacement control mechanism includes a plurality of gears.

[0292] Example 29: A delivery device as described in any example herein, particularly any one of Examples 24 to 26, wherein the delivery device further includes a displacement control mechanism, the displacement control mechanism being disposed in the main portion and coupled to the second shaft.

[0293] Example 30: A delivery device as described in any example herein, especially example 29, wherein the displacement control mechanism includes a plurality of gears.

[0294] Example 31: A delivery device as described in any example herein, especially any one of Examples 24 to 30, wherein the handle further includes a second knob rotatably coupled to the main portion, and the handle is configured such that rotating the second knob in a first direction relative to the main portion results in radial expansion of the prosthetic heart valve, and the handle is configured such that rotating the second knob in a second direction relative to the main portion results in radial compression of the prosthetic heart valve.

[0295] Example 32: A delivery device as described in any of the Examples herein, in particular any one of Examples 24 to 31, wherein the handle includes a first axially movable component and a second axially movable component, the handle is configured such that when the first knob is rotated from the first rotational position to the second rotational position, the first axially movable component is spaced apart from the second axially movable component and moves axially relative to the second axially movable component, and when the first knob is rotated from the second rotational position to a third rotational position, the first axially movable component moves axially with the second axially movable component.

[0296] Example 33: A delivery device as described in any of the examples herein, especially Example 32, wherein the first axially movable component is disposed distally relative to the second axially movable component.

[0297] Example 34: A delivery device as described in any example herein, especially Example 32 or Example 33, wherein the first axially movable component moves proximally relative to the second axially movable component when the first knob moves from the first rotational position to the second rotational position.

[0298] Example 35: A delivery device as described in any example herein, particularly any one of Examples 32 to 34, wherein the first axially movable component and the second axially movable component move proximally relative to the main portion when the first knob moves from the second rotational position to the third rotational position.

[0299] Example 36: A delivery device as described in any of the examples herein, especially any one of Examples 24 to 35, wherein the first knob is axially fixed relative to the main portion.

[0300] Example 37: A delivery device for implanting a prosthetic heart valve includes a first shaft having a first end portion and a second end portion; a second shaft having a first end portion and a second end portion, the second shaft extending through the first shaft; a nose cone coupled to the first end portion of the second shaft; and a handle including a main portion and an adjustment mechanism, the second end portion of the first shaft coupled to the main portion of the handle and the second end portion of the second shaft coupled to the adjustment mechanism, the adjustment mechanism configured such that axially moving the adjustment mechanism relative to the main portion results in axial movement of the second shaft relative to the first shaft.

[0301] Example 38: A delivery device as described in any example herein, especially example 37, wherein the adjustment mechanism includes a slidable knob extending from the main body portion.

[0302] Example 39: A delivery device as described in any example herein, especially Example 37 or Example 38, wherein the adjustment mechanism includes a locking member configured to selectively limit movement between the adjustment mechanism and the main portion.

[0303] Example 40: A delivery device as described in any example herein, especially example 39, wherein the locking member comprises a rotatable knob.

[0304] Example 41: A delivery device as described in any example herein, particularly any one of Examples 37 to 40, wherein the main body portion includes a slot and the adjustment mechanism extends through the slot.

[0305] Example 42: A delivery device as described in any example herein, especially any one of Examples 1 to 41, wherein the handle further comprises a force limiting assembly.

[0306] Example 43: A delivery device as described in any example herein, particularly any one of Examples 1 to 42, wherein the handle further comprises an adjustable biasing assembly.

[0307] Example 44: A delivery device as described in any of the examples herein, especially any one of Examples 1 to 43, wherein the handle further comprises a force distribution mechanism.

[0308] Example 45: A delivery device as described in any one of the examples herein, especially any one of Examples 1 to 44, wherein the handle further comprises a displacement control mechanism.

[0309] Example 46: A delivery device as described in any one of the examples herein, especially any one of Examples 1 to 45, wherein the handle further comprises an expansion limiting mechanism.

[0310] Example 47: A delivery device as described in any example herein, particularly any one of Examples 1 to 46, wherein the handle further comprises an indicator configured to provide an indication of expansion of the prosthetic heart valve.

[0311] Example 48: A delivery device for implanting a prosthetic heart valve includes: a first shaft having a first end portion and a second end portion, the first end portion of the first shaft configured to be releasably coupled to the prosthetic heart valve; and a handle including a main portion, a rotatable knob, and a locking mechanism, the rotatable knob rotatably coupled to the main portion and to the second end portion of the first shaft, and the locking mechanism configured to limit relative rotational movement of the rotatable knob and the main portion.

[0312] Example 49: A delivery device as described in any of the Examples herein, especially Example 48, wherein the locking mechanism includes a first gear, a second gear, a threaded member, an extension member, and a switch, wherein the first gear is fixedly coupled to the rotatable knob, the second gear is fixedly coupled to the threaded member and engaged with the first gear, the extension member extends from the threaded member and is axially movable relative to the threaded member, and the switch is movable relative to the extension member from a locked position to an unlocked position, wherein in the locked position the switch limits axial movement of the extension member and in the unlocked position the switch allows axial movement of the extension member.

[0313] Example 50: A delivery device as described in any of the examples herein, especially example 49, wherein the switch is a first switch of a plurality of switches, each of the switches being axially spaced apart from an adjacent switch, and each of the switches being movable between a locked position and an unlocked position.

[0314] Example 51: A delivery device as described in any example herein, particularly any one of Examples 1 to 50, wherein the handle further includes a ratchet mechanism configured to selectively enable rotation of the knob relative to the handle in a first rotational direction and selectively limit rotation of the knob relative to the handle in a second rotational direction.

[0315] Example 52: A delivery device as described in any example herein, particularly any one of Examples 1 to 51, wherein the handle further includes a valve rotation mechanism having a rotatable knob, the valve rotation mechanism configured to selectively enable rotation of a shaft of the delivery device and rotation of a prosthetic heart valve releasably coupled to the shaft when the rotatable knob is rotated relative to the handle.

[0316] Example 53: A delivery device as described in any example herein, particularly any one of Examples 1 to 52, wherein the handle further includes an extension mechanism, the extension mechanism including a rotatable knob and a pull plate, and the pull plate is configured to move axially relative to the rotated knob when the rotatable knob is rotated.

[0317] Example 54: A delivery device as described in any example herein, particularly any one of Examples 1 to 53, wherein the delivery device further includes a current monitoring mechanism, the current monitoring mechanism configured to provide an indication of whether the delivery device is coupled to a prosthetic heart valve.

[0318] Example 55: A delivery device as described in any of the examples herein, especially Example 54, wherein the handle of the delivery device includes a current monitor coupled to the electrical circuit, the current monitor sensing current when the delivery device is coupled to the prosthetic heart valve and not sensing current when the delivery device is released from the prosthetic heart valve.

[0319] Example 56: A delivery device as described in any one of the examples herein, particularly any one of Examples 1 to 55, wherein the delivery device further comprises a magnetic rotation counting mechanism.

[0320] Example 57: A delivery device as described in any of the examples herein, particularly any one of Examples 1 to 56, wherein the delivery device further comprises an electrical rotation counting mechanism.

[0321] Example 58: A delivery device as described in any of the examples herein, particularly any one of Examples 1 to 57, wherein the delivery device further comprises an optical rotation counting mechanism.

[0322] Example 59: A delivery device as described in any example herein, particularly any one of Examples 1 to 58, wherein the handle includes one or more of a visual indicator, an audible indicator, and a tactile indicator configured to indicate to a user whether the delivery device is coupled to a prosthetic heart valve.

[0323] Example 60: A delivery device for a prosthetic heart valve includes a handle having a proximal end, a distal end, and a cavity extending from the proximal end to the distal end; a plurality of actuating assemblies, each including a movable portion, each movable portion having a proximal end portion disposed within the cavity and a distal end portion disposed outside the cavity; a plate member, disposed within the cavity and axially movable relative to the handle, the plate member having a first state and a second state, in the first state, the plate member moves freely relative to the movable portion and in the second state, the plate member is engaged with the movable portion such that further axial movement of the plate member results in axial displacement of the movable portion; and a drive assembly, operably coupled to the plate member and operable to move the plate member axially relative to the handle.

[0324] Example 61: A delivery device as described in any of the examples herein, especially example 60, wherein each of the movable portions includes an actuation tube and an actuation member, the actuation member extending through and coupled to the actuation tube, and the plate member is positioned distal to the actuation tube, such that axial movement of the plate member in a direction toward the proximal end of the handle results in contact between the plate member and the actuation tube.

[0325] Example 62: A delivery device as described in any example herein, especially example 61, wherein the plate member includes a plurality of slots for passage of the actuation member.

[0326] Example 63: A delivery device as described in any example herein, especially Example 61 or Example 62, wherein the drive assembly includes a driving gear operably engaged with a first driven gear, the first driven gear being coupled to the plate member, and wherein rotation of the driving gear results in axial movement of the plate member relative to the handle.

[0327] Example 64: A delivery device as described in any of the examples herein, especially example 63, wherein the drive assembly further includes a plurality of second driven gears operably engaged with the driving gear, each of the second driven gears being coupled to one of the actuation tubes such that rotation of the driving gear results in rotation of the actuation member.

[0328] Example 65: A delivery device as described in any of the examples herein, especially Example 64, wherein the delivery device further includes a first rotatable knob coupled to the driving gear, wherein rotation of the first rotatable knob results in rotation of the driving gear.

[0329] Example 66: A delivery device as described in any example herein, especially any one of Examples 61 to 65, wherein the delivery device further includes a second rotatable knob coupled to the actuation member and the handle, wherein rotation of the second rotatable knob in a first direction applies a pulling force to the actuation member, and rotation of the second rotatable knob in a second direction opposite to the first direction releases the pulling force from the actuation member.

[0330] Example 67: A delivery device as described in any of the examples herein, especially Example 66, wherein the delivery device further includes a pulling force mechanism, the pulling force mechanism including a reel, the reel coupled to the second rotatable knob and to one of the actuating members, and the reel applies a pulling force from the second rotatable knob to one of the actuating members.

[0331] Example 68: A delivery device as described in any of the examples herein, especially Example 67, wherein the pulling force mechanism further includes one or more pulleys, the one or more pulleys being arranged to distribute the pulling force applied to one of the actuation members evenly among the actuation members.

[0332] Example 68A: A delivery device as described in any example herein, especially Example 67 or Example 68, wherein each actuating member includes a threaded head, an actuating flexible portion, and an actuating torque transmission portion extending between the threaded head and the actuating flexible portion, and wherein the actuating flexible portion of one of the actuating members is connected to a reel.

[0333] Example 69: A delivery device as described in any example herein, particularly any one of Example 67, Example 68, and Example 68A, wherein the delivery device further includes a tensioning assembly coupled to one of the actuating members, the tensioning assembly including a spring member arranged to apply tension to one of the actuating members.

[0334] Example 69A: A delivery device as described in any example herein, particularly any one of Examples 61 to 69, wherein the delivery device further includes: a first sensor member, the first sensor member coupled to at least one of the actuating members and rotatable with the at least one of the actuating members; a second sensor member positioned to detect a change in a rotational position of the first sensor member; and a circuit for counting a number of rotations of at least one of the actuating members from an output of the second sensor member, the circuit for generating an indication responsive to the number of rotations of at least one of the actuating members exceeding a predetermined threshold.

[0335] Example 70: A delivery device as described in any example herein, particularly any one of Examples 61 to 69A, wherein the delivery device further includes a shaft assembly coupled to the handle, the shaft assembly including: a first shaft axially movable relative to the handle, the first shaft having a first lumen; and a second shaft extending through the first lumen, the second shaft having one or more second lumens, the actuating member extending through the one or more second lumens.

[0336] Example 71: A delivery device as described in any of the Examples herein, especially Example 70, wherein the delivery device further includes: a third shaft extending through one of the one or more second lumens, the third shaft having a proximal end portion extending into the cavity, a distal end portion disposed outside the cavity, and a third lumen; and a nose cone coupled to the distal end portion of the third shaft, the nose cone having a central opening aligned with the third lumen for passage of a guidewire.

[0337] Example 72: A delivery assembly includes a delivery device described in any one of Examples 60 to 71 and a mechanically expandable prosthetic heart valve including a plurality of actuators operable to adjust a diameter of the prosthetic heart valve, wherein a movable portion of the actuation assembly is releasably coupled to the plurality of actuators and is axially movable to operate the plurality of actuators.

[0338] Example 73: The method includes inserting a distal end of the delivery assembly described in Example 72 into the patient's vascular system; advancing the distal end of the delivery assembly through the patient's vascular system to position the prosthetic heart valve at a selected implantation location; disengaging a movable portion of the actuation assembly from an actuator of the prosthetic heart valve; axially moving the plate member relative to the handle until the plate member engages the movable portion of the actuation assembly; and pulling the plate member and the movable portion of the actuation assembly to retract the movable portion of the actuation assembly from the prosthetic heart valve.

[0339] Example 74: A delivery device for a prosthetic heart valve includes: a handle having a proximal end, a distal end, and a cavity extending from the proximal end to the distal end; an actuation assembly including an actuation member and a sleeve member, the actuation member having a proximal end portion disposed within the cavity and a distal end portion disposed outside the cavity, the sleeve member being disposed around the distal end portion of the actuation member; a drive assembly coupled to the proximal end portion of the actuation member, the drive assembly operable to rotate the actuation member from within the cavity; a first sensor member, the first sensor member coupled to the actuation member and rotatable with the actuation member; and a second sensor member positioned to detect a change in rotational position of the first sensor member.

[0340] Example 75: A delivery device as described in any of the examples herein, especially example 74, wherein the second sensor member includes a conductive portion and the first sensor member includes a conductive arm extending radially from the at least one actuation member, the conductive arm contacting the conductive portion during a portion of each rotational cycle of the actuation member.

[0341] Example 76: A delivery device as described in any of the examples herein, especially example 75, wherein the second sensor member further includes a non-conductive portion, and the first sensor member contacts the non-conductive portion during a remaining portion of each rotational cycle of the at least one actuation member.

[0342] Example 77: A delivery device as described in any example herein, especially example 75 or example 76, wherein the second sensor member is mounted in a recess in the sleeve member.

[0343] Example 78: A delivery device as described in any of the examples herein, especially example 74, wherein the first sensor member includes at least two magnetic regions having opposite polarity, and the second sensor member includes a magnetic sensor positioned to detect changes in the magnetic field produced by the at least two magnetic regions.

[0344] Example 79: A delivery device as described in any of the examples herein, especially Example 74, wherein the first sensor member comprises a light absorbing material disposed on a portion of a surface of the actuating member, and the second sensor member comprises a first optical core positioned to emit light toward the surface of the actuating member and a second optical core positioned to receive light returned from the surface of the actuating member.

[0345] Example 80: A delivery device as described in any example herein, particularly any one of Examples 74 to 79, wherein the delivery device further includes circuitry for counting the number of rotations of the actuating member from the output of the second sensor member, and for generating an indication in response to the number of rotations of the actuating member exceeding a predetermined threshold.

[0346] Example 81: A delivery device as described in any of the examples herein, particularly any one of Examples 76 to 80, wherein the drive assembly includes a gear train.

[0347] Example 82: A delivery device for a prosthetic heart valve includes: a handle having a proximal end, a distal end, and a cavity extending from the proximal end to the distal end; an actuation assembly including an electrically conductive actuating member and a sleeve member, the actuating member having a proximal end portion disposed within the cavity and a distal end portion disposed outside the cavity, and the sleeve member being disposed about the distal end portion of the actuating member; a drive assembly coupled to the actuating member and the handle, the drive assembly operable to rotate the actuating member from within the cavity; an electrical circuit having an electrical communication path including the handle and the electrically conductive actuating member, the electrical circuit having an open state and a closed state, the open state corresponding to the electrically conductive actuating member being engaged with the prosthetic heart valve and the closed state corresponding to the electrically conductive actuating member being disengaged from the prosthetic heart valve; and a current sensor coupled to the electrical circuit to detect an electrical state of the electrical circuit.

[0348] Example 83: A delivery device for a prosthetic heart valve includes a handle having a proximal portion, a distal portion, and a longitudinal axis, the proximal portion and the distal portion being telescopically movable relative to one another along the longitudinal axis; a first shaft, the first shaft coupled to the distal portion and having a first lumen; a second shaft, the second shaft extending through the first lumen and coupled to the distal portion, such that relative movement between the proximal and distal portions results in axial movement of both the first and second shafts; and a knob coupled to the first shaft, where rotation of the knob moves the first shaft axially relative to the handle independent of the second shaft.

[0349] Example 84: A delivery device for a prosthetic heart valve includes a handle including an inner track; a first movable component, the first movable component positioned along the inner track and axially movable along the inner track; a first shaft having a proximal end and a distal end, the proximal end of the first shaft coupled to the first movable component; a second movable component, the second movable component positioned along the inner track and axially movable along the inner track; and a second shaft having a proximal end and a distal end, the proximal end of the second shaft coupled to the second movable component. a second shaft that engages the first movable component; and a knob coupled to the first movable component and rotatable to move the first movable component along the inner track, the first movable component being axially movable along the inner track between a first position and a second position, where in the first position the first movable component is axially separated from the second movable component and movement of the first movable component along the inner track results in movement of only the first shaft, and where in the second position the first movable component is engaged with the second movable component and movement of the first movable component results in movement of both the first shaft and the second shaft.

[0350] Example 85: A delivery device for a prosthetic heart valve includes a handle; a first shaft having a first end portion, a second end portion, and a first lumen extending from the first end portion to the second end portion, the first end portion coupled to the handle; a second shaft having a first end portion, a second end portion, and one or more second lumens, the second shaft extending through the first shaft; a third shaft extending through one of the one or more second lumens; and a slider mechanism coupled to the handle and the third shaft, the slider mechanism operable to axially displace the third shaft relative to the handle.

[0351] Example 86: A delivery device for a prosthetic heart valve includes a handle having a first portion and a second portion, the second portion being rotatable and slidable relative to the first portion; a receiver formed in the second portion and rotatable with the second portion; a shaft having a first end portion, a second end portion, and one or more lumens, the first end portion of the shaft being received in the receiver; and a plurality of actuating members extending through the one or more lumens of the shaft, the plurality of actuating members being rotatable by rotation of the receiver.

[0352] Example 87: A delivery device as described in any example herein, especially example 86, wherein the delivery device further comprises a knob coupled to the receiving portion, and the receiving portion is rotatable by rotation of the knob.

[0353] Example 88: A delivery device as described in any example herein, especially Example 86 or Example 87, wherein the delivery device further includes a non-circular casing that mates with a socket in the receiver, and the first end portion of the handle is connected to the non-circular casing.

[0354] Example 89: A delivery device for a prosthetic heart valve, the delivery device including: a handle having a proximal portion, a distal portion, and a cavity extending from the proximal portion to the distal portion, the proximal portion having a slot formed therein; a slidable knob slidably engaged with the slot; a multi-lumen shaft having a proximal end portion, a distal end portion, and a plurality of first lumens, the proximal end portion of the multi-lumen shaft being disposed in the cavity; and a first shaft extending through one of the first lumens, the first shaft having a proximal end portion and a distal end portion, the proximal end portion of the first shaft being coupled to the slidable knob, wherein movement of the slidable knob along the slot results in axial displacement of the first shaft relative to the handle.

[0355] Example 90: A delivery device as described in any example herein, especially example 89, wherein the delivery device further includes a slider inner body portion disposed within the cavity, and the slidable knob is coupled to the slider inner body portion.

[0356] Example 91: A delivery device as described in any example herein, especially example 90, wherein the slider inner body portion includes a recess and the proximal end portion of the first shaft is received within the recess.

[0357] Example 92: A delivery device as described in any one of the examples herein, particularly any one of Examples 1 to 3, wherein the delivery device further comprises a nose cone coupled to a distal end portion of the first shaft.

[0358] Example 93: A delivery device described in any one of the examples herein, particularly any one of Examples 1 to 4, wherein the delivery device further includes an outer shaft having a proximal end portion, a distal end portion, and a second lumen, and the multi-lumen shaft extends through the second lumen.

[0359] Example 94: A delivery device as described in any of the Examples herein, especially Example 5, wherein the delivery device further includes a drive assembly coupled to the handle and a proximal end portion of the outer shaft, the drive assembly including a lead member rotatably supported within the cavity, and rotation of the lead member results in axial movement of the outer shaft relative to the handle.

[0360] Example 95: A delivery device as described in any example herein, especially example 94, wherein the delivery device further includes a rotatable knob coupled to the lead member, wherein rotation of the rotatable knob results in rotation of the lead member.

[0361] Example 96: A delivery device as described in any example herein, especially example 94 or example 95, wherein the drive assembly further includes a nut, the nut being threadably engaged with the lead member and having a bore for receiving a proximal end portion of the outer shaft, and rotation of the lead member results in axial movement of the nut and the outer shaft.

[0362] Example 97: A delivery device as described in any example herein, especially example 96, wherein the drive assembly further includes an axial guide, the axial guide positioned to guide movement of the nut in the axial direction.

[0363] Example 98: A delivery device as described in any example herein, especially Example 96 or Example 97, wherein the delivery device further includes a guide head disposed within the cavity, the guide head having a bore for receiving a proximal end portion of the multi-lumen shaft.

[0364] Example 99: A delivery device as described in any example herein, especially example 98, wherein the delivery device further includes a flushing port fluidly connected to the bore in the guide head, the flushing port extending outside the handle.

[0365] Example 100: A delivery device as described in any of the examples herein, especially example 98, wherein the delivery device further includes a load cell positioned in contact with the guide head and measures the force transmitted through the multi-lumen shaft.

[0366] Example 101: A delivery device for a prosthetic heart valve, the delivery device comprising: a handle having a proximal portion, a distal portion, and a cavity extending from the proximal portion to the distal portion; a multi-lumen shaft having a proximal end portion, a distal end portion, and a plurality of first lumens, the proximal end portion of the multi-lumen shaft being disposed within the cavity; and a plurality of actuating members extending through one or more of the first lumens, each of the actuating members having a distal threaded head, a proximal actuating flexible portion, and a distal threaded head and proximal actuating flexible portion. a plurality of actuating members having an actuation torque transmission portion extending between the proximal actuating flexible portion and the recompression member; a recompression member extending through one of the first lumens; and a tensioning force mechanism at least partially disposed within the cavity, the tensioning force mechanism coupled to the proximal actuating flexible portion and the recompression member, the tensioning force mechanism operable to apply a pulling force to the proximal actuating flexible portion in a first mode and to apply a pulling force to the recompression member in a second mode.

[0367] Example 102: A delivery device as described in any of the examples herein, particularly example 101, wherein the delivery device further includes a first rotatable knob coupled to a tension force mechanism, wherein rotation of the first rotatable knob in a first direction applies a tension force to the proximal actuation flexible portion, and rotation of the first rotatable knob in a second direction opposite the first direction applies a tension force to the recompression member.

[0368] Example 103: A delivery device as described in any example herein, especially Example 101 or Example 102, wherein the delivery device further includes a gear mechanism coupled to the multiple actuating members and operable to rotate the multiple actuating members simultaneously.

[0369] Example 104: A delivery device as described in any of the examples herein, especially example 103, wherein the delivery device further includes a second rotatable knob engaged with the gear mechanism, and rotation of the second rotatable knob operates the gear mechanism.

[0370] Features described herein with respect to any example may be combined with other features described in any one or more of the other examples, unless otherwise noted. For example, any example that includes a force control mechanism (and / or any components thereof) may be combined with any example that includes a displacement control mechanism (and / or any components thereof).

[0371] In view of the many possible ways in which the principles of this disclosure may be applied, it should be recognized that the illustrated configurations illustrate examples of the disclosed technology and should not be construed as limiting the scope of the disclosure or the claims that follow. Rather, the scope of claimed subject matter is defined by the following claims and their equivalents. [Explanation of symbols]

[0372] 10 Delivery Assembly 11 Shaft assembly 12 Delivery device 13 Proximal end 14 Outer Shaft 15 Distal end 16 Distal capsule 17 Lumens 18 Proximal end portion 22 Multi-lumen shaft 32 Actuation Assembly 34 Sleeve member 38 Sleeve Coupler 39 Opening 40 Operating member 42 Operating torque transmission part 44 Distal Threaded Head 46 Flexible operating part 50 Nosecone 56 Nose cone shaft 57 Guidewire lumen 60 Artificial Valves 62 Rocker / Actuator 63 Valve structure 64 Housing parts 80 Recompression shaft 100 Handle 107 Cavity 120 Rotatable Knob 136 Slidable Knob 138 Knob Rocker 140 Slots 142 Lead material 144 Leadbore 172 Spreader plate 173 Guide Plate 178 Connector 220 Adjustable Actuation Assembly 222 Plunger 224 Adjustment Nut 226 Cylinder 228 Radial Extension 232 energizing spring 234 Force Limiting Mechanism 236 Pivoting Arm 242 Arm pulley 244 Guide Pulley 248 Base 250 Force Balancing Assembly 364 Working Tube

Claims

[Claim 1] 1. A delivery device for a prosthetic heart valve, the delivery device comprising: a handle having a proximal end, a distal end, and a cavity extending from the proximal end to the distal end; a plurality of actuation assemblies, each of the actuation assemblies including a movable portion, each movable portion having a proximal end portion disposed within the cavity and a distal end portion disposed outside the cavity; a plate member disposed within the cavity and axially movable relative to the handle, the plate member having a first state and a second state, in the first state the plate member moves freely relative to the movable portion and in the second state the plate member engages the movable portion such that further axial movement of the plate member results in axial displacement of the movable portion; a drive assembly operatively coupled to the plate member and operable to axially move the plate member relative to the handle; A delivery device comprising:

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