Delivery apparatus and methods for implanting prosthetic heart valves

Abstract

To provide implantable, mechanically expandable prosthetic devices, such as prosthetic heart valves, and delivery apparatus and methods for implanting the prosthetic heart valves.SOLUTION: A delivery apparatus for implanting a prosthetic valve includes a handle, a first shaft, a plurality of actuation shafts, and a control mechanism. The first shaft has one or more lumens extending from a first end portion to a second end portion. The actuation shafts each have a proximal end portion and a distal end portion, and the actuation shafts extend through the one or more lumens of the first shaft. The control mechanism is coupled to the actuation shafts and to the handle. The control mechanism is configured such that the actuation shafts can move axially relative to each other in a first operational mode and such that the actuation shafts can be moved axially simultaneously in a second operational mode. Additionally or alternatively, the first shaft can include a plurality of helical lumens configured for receiving the actuation shafts.SELECTED DRAWING: Figure 23

Description

[Technical Field]

[0001] [CROSS-REFERENCE TO RELATED APPLICATIONS] This application claims the benefit of U.S. Provisional Patent Application No. 62 / 945,039, filed December 6, 2019, which is incorporated herein by reference.

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

[0003] The human heart can suffer from a variety of valvular heart diseases. These valvular heart diseases can result in significant cardiac dysfunction, ultimately requiring repair of the native valve or replacement of the native valve with a prosthetic valve. There are numerous known repair devices (e.g., stents) and prosthetic valves, as well as numerous known methods for implanting these devices and prosthetic valves in humans. Percutaneous, minimally invasive surgical approaches are utilized in various procedures to deliver prosthetic medical devices to internal locations not readily accessible by surgery or where non-surgical access is desirable. In one specific example, a prosthetic heart valve may be crimped onto the distal end of a delivery device and advanced through the patient's vasculature (e.g., through the femoral artery and aorta) until the prosthetic heart valve reaches the implantation site within the heart. The prosthetic heart valve is then expanded to its functional size, such as by inflating a balloon on which the prosthetic 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 in the delivery device so that the prosthetic heart valve can self-expand to its functional size.

[0004] A prosthetic heart valve that relies on a mechanical actuator for expansion can be referred to as a "mechanically expandable" prosthetic heart valve. Mechanically expandable prosthetic heart valves can have one or more advantages over self-expanding prosthetic heart valves and balloon-expandable prosthetic heart valves. For example, mechanically expandable prosthetic heart valves can be expanded to a variety of diameters. Mechanically expandable prosthetic heart valves can also be compressed after initial expansion (e.g., for repositioning and / or retrieval).

[0005] Despite these advantages, mechanically expandable prosthetic heart valves can have several drawbacks. For example, it can be difficult to control the forces applied to the prosthetic heart valve and / or delivery device during the implantation procedure. These drawbacks can be further compounded when the delivery device is disposed within a tortuous passageway, such as a patient's vasculature. It can also be difficult to release the mechanically expandable prosthetic heart valve from the delivery device. Furthermore, with multiple moving components to control, typical delivery devices can be difficult and / or time-consuming for the user to operate. Therefore, there is a need for improved delivery devices and methods for implanting mechanically expandable prosthetic heart valves. [Prior art documents] [Patent documents]

[0006] [Patent Document 1] U.S. Patent No. 10,603,165 [Patent Document 2] U.S. Patent No. 10,806,573 [Patent Document 3] US Patent Application Publication No. 2018 / 0344456 [Patent Document 4] International Publication No. 2020 / 081893 [Patent Document 5] International Publication No. 2021 / 003167 [Patent Document 6] U.S. Patent No. 9,700,442 [Patent Document 7] U.S. Patent No. 9,827,093 [Patent Document 8] U.S. Patent No. 6,730,118 [Patent Document 9] U.S. Patent No. 7,393,360 [Patent Document 10] U.S. Patent No. 7,510,575 [Patent Document 11] U.S. Patent No. 7,993,394 [Patent Document 12] U.S. Patent No. 8,652,202 [Patent Document 13] US Patent Application Publication No. 2018 / 0325665 [Patent Document 14] International Publication No. 2021 / 016018 Summary of the Invention [Problem to be solved by the invention]

[0007] Described herein are prosthetic heart valves, delivery devices, and methods for implanting the prosthetic heart valves. The disclosed delivery devices and methods can be effective, for example, in ensuring that forces applied by the delivery device to the prosthetic valve are evenly distributed, which can reduce the likelihood of damage to the delivery device and / or the prosthetic heart valve during the implantation procedure. The disclosed delivery devices and methods can also be effective in ensuring that the prosthetic heart valve is evenly expanded. The disclosed delivery devices are also relatively simple and / or easy to use, which can reduce the risk of failure and / or shorten the time required to implant the prosthetic heart valve, for example. [Means for solving the problem]

[0008] In one exemplary embodiment, a delivery device for implanting a prosthetic heart valve is provided. The delivery device includes a handle, a first shaft, multiple actuation shafts, and a control mechanism. The first shaft has a first end portion, a second end portion, and one or more lumens extending from the first end portion to the second end portion. The first end portion is coupled to the handle. Each actuation shaft has a proximal end portion and a distal end portion, and the actuation shafts extend through the one or more lumens of the first shaft. The control mechanism is coupled to the actuation shafts and to the handle. The control mechanism has a first mode of operation and a second mode of operation. In the first mode of operation, the proximal end portions of the actuation shafts can be moved axially relative to each other and the first shaft, and in the second mode of operation, the actuation shafts can be moved axially simultaneously.

[0009] In some embodiments, the delivery device is part of a delivery assembly that further comprises a mechanically expandable prosthetic heart valve.

[0010] In another exemplary embodiment, a delivery device includes a handle, a first shaft, multiple actuation shafts, and a force control mechanism. The first shaft has a first end portion, a second end portion, and one or more lumens extending from the first end portion to the second end portion. The first end portion is coupled to the handle. Each actuation shaft has a proximal end portion and a distal end portion, and the actuation shaft extends through the one or more lumens of the first shaft. The force control mechanism is coupled to the actuation shafts and to the handle. The force control mechanism is configured to allow the proximal end portions of the actuation shafts to move axially relative to each other when the first shaft is bent.

[0011] In some embodiments, the force control mechanism comprises a pulley system interconnected with the actuation shaft.

[0012] In another exemplary embodiment, a delivery device includes a handle, a first shaft, multiple actuation shafts, and a displacement control mechanism. The first shaft has a first end portion, a second end portion, and one or more lumens extending from the first end portion to the second end portion. The first end portion is coupled to the handle. Each actuation shaft has a proximal end portion and a distal end portion, and the actuation shaft extends through the one or more lumens of the first shaft. The displacement control mechanism is coupled to the actuation shafts and to the handle. The displacement control mechanism is configured to allow the proximal end portions of the actuation shafts to move axially relative to each other when the first shaft is bent.

[0013] In some embodiments, the displacement control mechanism comprises one or more gear assemblies.

[0014] In another exemplary embodiment, a delivery device includes a handle, a first shaft, and multiple actuation shafts. The first shaft has a first end portion, a second end portion, and multiple helical lumens extending from the first end portion to the second end portion. The first end portion is coupled to the handle. Each actuation shaft has a proximal end portion and a distal end portion, and an actuation shaft extends through a respective helical lumen of the first shaft.

[0015] In another exemplary embodiment, a delivery device includes a handle, a first shaft, multiple actuation shafts, a force control mechanism, and a displacement control mechanism. The first shaft has a first end portion, a second end portion, and one or more lumens extending from the first end portion to the second end portion. The first end portion is coupled to the handle. Each actuation shaft has a proximal end portion and a distal end portion, and the actuation shaft extends through the one or more lumens of the first shaft. The force control mechanism is coupled to the actuation shafts and to the handle. The force control mechanism is configured to allow the proximal end portions of the actuation shafts to move axially relative to each other when the first shaft is bent. The displacement control mechanism is coupled to the actuation shafts and to the handle. The displacement control mechanism is configured to allow the proximal end portions of the actuation shafts to move axially relative to each other when the first shaft is bent.

[0016] In another exemplary embodiment, a delivery device includes a handle, a first shaft, multiple actuation shafts, and a force control mechanism. The first shaft has a first end portion, a second end portion, and multiple helical lumens extending from the first end portion to the second end portion. The first end portion is coupled to the handle. Each actuation shaft has a proximal end portion and a distal end portion, and the actuation shaft extends through each helical lumen of the first shaft. The force control mechanism is coupled to the actuation shafts and configured to evenly distribute force applied to the actuation shafts.

[0017] In another exemplary embodiment, a delivery device includes a handle, a first shaft, multiple actuation shafts, and a displacement control mechanism. The first shaft has a first end portion, a second end portion, and multiple helical lumens extending from the first end portion to the second end portion. The first end portion is coupled to the handle. Each actuation shaft has a proximal end portion and a distal end portion, and the actuation shaft extends through each of the helical lumens of the first shaft. The displacement control mechanism is coupled to the actuation shafts and configured to allow the proximal end portions of the actuation shafts to move axially relative to each other when the first shaft is bent.

[0018] In another exemplary embodiment, a delivery device includes a handle, a first shaft, multiple actuation shafts, a force control mechanism, and a displacement limiting device. The first shaft has a first end portion, a second end portion, and multiple helical lumens extending from the first end portion to the second end portion. The first end portion is coupled to the handle. Each actuation shaft has a proximal end portion and a distal end portion, and the actuation shaft extends through each of the helical lumens of the first shaft. The force control mechanism is coupled to the actuation shafts and configured to uniformly distribute force applied to the actuation shafts. The displacement control mechanism is coupled to the actuation shafts and configured to allow the proximal end portions of the actuation shafts to move axially relative to each other when the first shaft is bent.

[0019] In another exemplary embodiment, a force control mechanism for a delivery device for implanting a prosthetic heart valve is provided. The force control mechanism includes a pulley system and a movable carriage. The pulley system is configured to interconnect multiple actuation shafts of the delivery device. The movable carriage is coupled to the pulley system and configured to be movably coupled to a handle of the delivery device. The pulley system and the movable carriage are configured to move axially and / or rotationally to balance forces applied to and / or transmitted by the actuation shafts of the delivery device.

[0020] In another exemplary embodiment, a force control mechanism for a delivery device for implanting a prosthetic heart valve is provided. The force control mechanism includes a first pulley, a second pulley, a third pulley, and a carriage. The first pulley is configured to be coupled to a first actuation shaft and a second actuation shaft of the delivery device. The second pulley is configured to be coupled to a third actuation shaft of the delivery device. The third pulley is configured to be coupled to the third actuation shaft of the delivery device. The carriage is configured to be movably coupled to a handle of the delivery device. The first pulley and the second pulley are rotatably coupled to the carriage, and the carriage is axially movable relative to the third pulley. Proximal end portions of the first actuation shaft and the second actuation shaft move axially relative to each other, and the first pulley rotates when tension in the first actuation shaft and the second actuation shaft is unequal. When the tension in the third actuation shaft and the first actuation shaft or the second actuation shaft is not equal, the proximal end portion of the third actuation shaft moves axially relative to the first actuation shaft and the second actuation shaft, and the second pulley and the third pulley rotate.

[0021] In another exemplary embodiment, a displacement control mechanism for a delivery device configured to implant a prosthetic heart valve is provided. The displacement control mechanism includes one or more gear assemblies configured to be coupled to actuation shafts of the delivery device. The gear assemblies are configured to allow proximal end portions of the actuation shafts to independently move axially relative to one another and simultaneously rotate the actuation shafts about their respective axes.

[0022] In another exemplary embodiment, a shaft for a delivery device configured for implanting a prosthetic heart valve is provided, the shaft including a plurality of helical lumens extending from a first end portion of the shaft to a second end portion of the shaft, each helical lumen configured to receive an actuation shaft of the delivery device.

[0023] The various embodiments of the present disclosure can be used in combination or separately. This Summary is provided to introduce selected concepts in a simplified form that are further described below in the Detailed Description. This Summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. The foregoing and other objects, features, and advantages of the present disclosure will become more apparent from the following Detailed Description, the claims, and the accompanying drawings. [Additional note 1] 1. A delivery device for a prosthetic valve, comprising: The handle and a first shaft having a first end portion, a second end portion, and one or more lumens extending from the first end portion to the second end portion, the first end portion being coupled to the handle; a plurality of actuation shafts, each having a proximal end portion and a distal end portion, the actuation shafts extending through the one or more lumens of the first shaft; a control mechanism coupled to the actuation shaft and to the handle, the control mechanism having a first mode of operation and a second mode of operation, wherein in the first mode of operation, the proximal end portions of the actuation shafts are axially movable relative to each other and relative to the first shaft, and in the second mode of operation, the actuation shafts are axially movable simultaneously; A delivery device comprising: [Additional note 2] 10. The delivery device of claim 1, wherein the control mechanism includes a force control mechanism. [Additional note 3] 3. The delivery device of claim 2, wherein the force control mechanism includes a pulley, wherein the proximal end portions of two of the actuation shafts are coupled together via the pulley, and wherein when tension forces acting on the two of the actuation shafts are unequal, the proximal end portions of the two of the actuation shafts move axially relative to each other and the pulley rotates. [Additional note 4] the plurality of actuation shafts include a first actuation shaft, a second actuation shaft, and a third actuation shaft; the force control mechanism includes a carriage, a first pulley, a second pulley, and a third pulley; the carriage is movable relative to the handle; the first pulley and the second pulley are rotatably attached to the carriage; the third pulley is fixed relative to the handle; the proximal end portions of the first actuation shaft and the second actuation shaft are coupled together via the first pulley; the third actuation shaft extends around the second pulley and the third pulley; when tension acting on the first actuation shaft is different from tension acting on the second actuation shaft, the proximal end portions of the first actuation shaft and the second actuation shaft move axially relative to each other and the first pulley rotates; 3. The delivery device of claim 2, wherein when the tension acting on the third actuation shaft is different from the tension acting on the first actuation shaft and the second actuation shaft, the proximal end portion of the third actuation shaft moves relative to the first actuation shaft and the second actuation shaft, and the second pulley and the third pulley rotate. [Additional note 5] 5. The delivery device of any one of clauses 1 to 4, further comprising an actuation mechanism coupled to one of the actuation shafts, the actuation mechanism configured to simultaneously axially move the actuation shafts. [Additional note 6] the actuation mechanism comprises a rotatable knob; 6. The delivery device of claim 5, wherein rotation of the rotatable knob simultaneously moves the actuation shaft axially. [Additional note 7] the actuation mechanism comprises an electric motor having a rotatable shaft; 6. The delivery device of claim 5, wherein rotation of the rotatable shaft simultaneously moves the actuation shaft axially. [Additional note 8] 8. The delivery device of any one of clauses 5 to 7, wherein the actuation mechanism comprises a spool configured to increase or decrease tension acting on the actuation shaft. [Additional note 9] 9. The delivery device of any one of clauses 1 to 8, wherein the control mechanism includes a displacement control mechanism. [Additional Note 10] the displacement control mechanism includes a gear assembly having an outer gear and a plurality of inner gears; The internal gears are coupled to respective actuation shafts; 10. The delivery device of claim 9, wherein rotating the outer gear relative to the first shaft causes the inner gear and the actuation shaft to simultaneously rotate relative to the first shaft. [Additional Note 11] the displacement control mechanism includes a first gear assembly and a second gear assembly; rotating the first gear assembly relative to the first shaft simultaneously moves the actuation shaft axially relative to the first shaft; 10. The delivery device of claim 9, wherein rotating the second gear assembly relative to the first shaft simultaneously rotates the actuation shaft relative to the first shaft. [Additional Note 12] the first gear assembly is coupled to an actuation mechanism; The delivery device of claim 11, wherein the second gear assembly is coupled to a release mechanism. [Additional Note 13] the displacement control mechanism includes a sliding external gear configured to be moved between a first position and a second position; In the first position, the sliding outer gear engages a plurality of first inner gears of the first gear assembly; 13. The delivery device of claim 11 or claim 12, wherein in the second position, the sliding outer gear engages with a plurality of second inner gears of the second gear assembly. [Additional Note 14] the displacement control mechanism includes a coupling member, an actuating member, and a gear assembly; the coupling member is coupled to the distal end portion of the actuation shaft; the actuation member extends through the first shaft; a first end portion of the actuation member coupled to the coupling member; the gear assembly is coupled to the proximal end portion of the actuation shaft; Axial movement of the actuating member relative to the first shaft simultaneously moves the coupling member and the actuating shaft axially relative to the first shaft and the gear assembly; 10. The delivery device of claim 9, wherein rotating the gear assembly relative to the first shaft simultaneously rotates the actuation shaft relative to the first shaft. [Additional Note 15] 15. The delivery device of claim 14, wherein the actuation member is coupled to an actuation mechanism. [Additional Note 16] A delivery device according to any one of claims 1 to 15; a mechanically expandable prosthetic heart valve; A delivery assembly comprising: [Additional Note 17] The mechanically expandable prosthetic heart valve comprises a frame including a plurality of struts and a plurality of actuators; the struts of the frame are pivotally coupled together; 17. The delivery assembly of claim 16, wherein the actuator is coupled to the struts of the frame and configured to transition the frame between a radially compressed configuration and a radially expanded configuration. [Additional Note 18] 18. The delivery assembly of claim 17, wherein the actuation shaft of the delivery device is releasably coupled to the actuator of the prosthetic heart valve such that relative axial movement between the actuation shaft and the first shaft transitions the frame of the prosthetic heart valve between the radially compressed configuration and the radially expanded configuration. [Brief explanation of the drawings]

[0024] [Figure 1] FIG. 1 is a perspective view of a delivery assembly including a mechanically expandable prosthetic heart valve and a delivery device. [Figure 2] FIG. 1 is a perspective view of a prosthetic heart valve. [Figure 3] FIG. 10 is another perspective view of the prosthetic heart valve without the valve structure, with the frame of the prosthetic heart valve in a radially expanded configuration. [Figure 4] FIG. 1 is a side view of a prosthetic heart valve in a radially compressed configuration. [Figure 5] FIG. 1 is a detailed view of the actuator of the prosthetic heart valve. [Figure 6] 1 is a cross-sectional view of an actuator of a prosthetic heart valve. [Figure 7] FIG. 10 is a side view of the proximal end portion of the delivery device. [Figure 8] FIG. 10 is a side view of a distal end portion of a delivery device. [Figure 9] 9 is a cross-sectional view of the shaft of the delivery device taken along line 9-9 shown in FIG. 8. [Figure 10] FIG. 10 is a detailed view of the distal end portion of the shaft of the delivery device. [Figure 11] FIG. 1 is a detailed view of the prosthetic heart valve released from the delivery device. [Figure 12] FIG. 1 is a detailed view of a prosthetic heart valve coupled to a delivery device. [Figure 13]FIG. 1 is a side view of a prosthetic heart valve coupled to a delivery device, with the prosthetic heart valve in a radially expanded configuration. [Figure 14] FIG. 1 is a side view of a prosthetic heart valve coupled to a delivery device, with the prosthetic heart valve in a radially compressed configuration. [Figure 15] FIG. 10 is a side view of a distal end portion of a delivery device. [Figure 16] 1A-1C illustrate an example implantation procedure in which a prosthetic heart valve is implanted in a heart (shown in cross section) along with a delivery device. [Figure 17] 1A-1C illustrate an example implantation procedure in which a prosthetic heart valve is implanted in a heart (shown in cross section) along with a delivery device. [Figure 18] 1A-1C illustrate an example implantation procedure in which a prosthetic heart valve is implanted in a heart (shown in cross section) along with a delivery device. [Figure 19] 1A-1C illustrate an example implantation procedure in which a prosthetic heart valve is implanted in a heart (shown in cross section) along with a delivery device. [Figure 20] FIG. 1 is a schematic diagram of a handle of a delivery device including an example force control mechanism. [Figure 21] FIG. 10 is a schematic diagram of another handle of a delivery device including another example force control mechanism. [Figure 22] FIG. 10 is a schematic diagram of a handle of a delivery device including a force control mechanism according to another embodiment. [Figure 23] FIG. 1 is a side view of an example delivery device including a displacement control mechanism. [Figure 24] FIG. 24 is a perspective view of a coupling member of an example of the displacement control mechanism of FIG. 23. [Figure 25] FIG. 24 is a detailed view of the distal end portion of the displacement control mechanism of FIG. 23, showing the coupling member in a distal position. [Figure 26] FIG. 24 is a detailed view of the distal end portion of the displacement control mechanism of FIG. 23, showing the coupling member in a proximal position. [Figure 27] FIG. 24 is a perspective view of an inner gear of the example displacement control mechanism of FIG. 23. [Figure 28] FIG. 24 is a perspective view of an inner gear of the example displacement control mechanism of FIG. 23. [Figure 29]FIG. 24 is a perspective view of an outer gear of the example displacement control mechanism of FIG. 23. [Figure 30] FIG. 24 is an end view of a gear assembly of the example displacement control mechanism of FIG. [Figure 31] FIG. 24 is a partial cross-sectional view of a gear assembly of the displacement control mechanism of FIG. [Figure 32] FIG. 10 is a side view of a delivery device including a displacement control mechanism according to another embodiment. [Figure 33] FIG. 33 is a detailed view of the distal end portion of the displacement control mechanism of FIG. 32. [Figure 34] FIG. 33 is a cross-sectional view showing a distal end portion of the displacement control mechanism of FIG. 32. [Figure 35] FIG. 10 is a perspective view of a proximal end portion of a delivery device including a displacement control mechanism according to another embodiment. [Figure 36] FIG. 36 is a perspective view of a first gear assembly of the example displacement control mechanism of FIG. 35. [Figure 37] FIG. 36 is a perspective view of components of one example of a first gear assembly of the displacement control mechanism of FIG. [Figure 38] FIG. 36 is a perspective view of components of one example of a first gear assembly of the displacement control mechanism of FIG. [Figure 39] FIG. 36 is a perspective view of components of one example of a first gear assembly of the displacement control mechanism of FIG. [Figure 40] FIG. 36 is a perspective view of a second gear assembly of the example displacement control mechanism of FIG. 35. [Figure 41] FIG. 36 is a perspective view of an example sliding external gear and displacement control mechanism of FIG. 35, showing the external gear in a proximal position. [Figure 42] FIG. 36 is a perspective view of the previously shown sliding external gear and displacement control mechanism of FIG. 35, showing the external gear in a distal position. [Figure 43] FIG. 10 is a top view of a proximal end portion of a delivery device including another example displacement control mechanism. [Figure 44] FIG. 44 is an end view of a first gear assembly of the example displacement control mechanism of FIG. 43. [Figure 45] FIG. 44 is an end view of a second gear assembly of the example displacement control mechanism of FIG. 43. [Figure 46] FIG. 44 is a partial cross-sectional view of the first gear assembly of the displacement control mechanism of FIG. 43, showing the first gear assembly in an unlocked configuration. [Figure 47] FIG. 44 is a partial cross-sectional view of the first gear assembly of the displacement control mechanism of FIG. 43, showing the first gear assembly in a locked configuration. [Figure 48] FIG. 10 is a side view of an example shaft for a delivery device. [Figure 49] FIG. 49 is a cross-sectional view of the shaft of FIG. 48. [Figure 50] FIG. 49 is a cross-sectional view of the shaft of FIG. 48. [Figure 51] FIG. 49 is a cross-sectional view of the shaft of FIG. 48. DETAILED DESCRIPTION OF THE INVENTION

[0025] General matters This detailed description describes certain aspects, advantages, and novel features of embodiments of the present disclosure. These disclosed methods, apparatus, and systems should not be construed as limiting in any respect. Rather, the present disclosure is directed to all novel and non-obvious features and aspects of the various disclosed embodiments, alone and in various combinations and subcombinations with each other. These methods, apparatus, and systems are not limited to any particular aspect or feature thereof or combination thereof, nor are embodiments of the present disclosure required for any particular advantage or advantages to be present or problems to be solved.

[0026] Although some operations in the embodiments of the present disclosure are described in a particular sequential order for convenience of presentation, it should be understood that this method of description encompasses reordering unless a particular order is required by specific language set forth below. For example, a series of operations described sequentially may in some cases be reordered or performed simultaneously. Moreover, for reasons of simplicity, the accompanying drawings may not show various ways in which the methods of the present disclosure may be utilized in combination with other methods. Furthermore, at times, the description uses terms such as "implement" or "achieve" to describe the methods of the present disclosure. These terms are highly abstract representations of actual operations that are performed. The actual operations corresponding to these terms may vary depending on the specific implementation and are readily discernible by those skilled in the art.

[0027] In this application and claims, the singular forms "a," "an," and "the" include the plural unless the context clearly dictates otherwise. Furthermore, the term "include" means "comprise." Furthermore, the term "coupled" generally means physically, mechanically, chemically, magnetically, and / or electrically coupled or linked, and does not exclude the presence of intermediate elements between coupled or associated items, unless specifically stated to the contrary.

[0028] As used herein, the term "proximal" refers to a position, orientation, or portion of a device that is closer to the user and farther away from the implantation site. As used herein, the term "distal" refers to a position, orientation, or portion of a device that is farther away from the user and closer to the implantation site. Thus, for example, proximal movement of a device is movement of the device away from the implantation site toward the user (e.g., outside the patient's body), and 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," unless expressly defined otherwise, refer to axes extending in the proximal and distal directions.

[0029] Examples of the techniques of the present disclosure Described herein are prosthetic heart valves, delivery devices, and methods for implanting the prosthetic heart valves. The disclosed delivery devices and methods can be effective, for example, in ensuring that forces applied by the delivery device to the prosthetic valve are evenly distributed, which can reduce the likelihood of damage to the delivery device and / or the prosthetic heart valve during the implantation procedure. The disclosed delivery devices and methods can also be effective in ensuring that the prosthetic heart valve is evenly expanded. The disclosed delivery devices are also relatively simple and / or easy to use, which can reduce the risk of failure and / or shorten the time required to implant the prosthetic heart valve, for example.

[0030] FIG. 1 illustrates a delivery assembly 10 according to one embodiment. In the illustrated embodiment, the delivery assembly 10 includes a prosthetic heart valve 100 and a delivery device 200. The prosthetic valve 100 may be configured to replace a native heart valve (e.g., an aortic valve, a mitral valve, a pulmonary valve, and / or a tricuspid valve). As illustrated, the prosthetic valve 100 may be releasably coupled to a distal end portion of the delivery device 200. The delivery device 200 may be used to deliver and implant the prosthetic valve 100 into a patient's native heart valve (see, e.g., FIGS. 16-19 ). Further details regarding the prosthetic valve 100 and the delivery device 200 are provided below.

[0031] 2 illustrates a prosthetic valve 100. As illustrated, the prosthetic valve 100 comprises three main components: a frame 102, a valve structure 104, and one or more actuators 106 (three actuators in the illustrated embodiment). The frame 102 (which may also be referred to as a "stent" or a "support structure") may be configured to support the valve structure 104 and to anchor the prosthetic valve 100 within the native heart valve. The valve structure 104 is coupled to the frame 102 and / or the actuators 106. The valve structure 104 is configured to allow blood flow through the prosthetic valve 100 in one direction (i.e., the antegrade direction) and restrict blood flow in the opposite direction (i.e., the retrograde direction) through the prosthetic valve 100. An actuator 106 is coupled to the frame 102 and configured to adjust the expansion of the frame 102 to a plurality of configurations, including one or more functional or expanded configurations (e.g., FIGS. 2-3), one or more delivery or compressed configurations (e.g., FIG. 4), and / or one or more intermediate configurations intermediate the functional and delivery configurations. Note that the valve structure 104 of the prosthetic valve 100 is not shown in FIGS. 1 and 3-4 for illustrative purposes.

[0032] 3, the frame 102 of the prosthetic valve 100 has a first end 108 and a second end 110. In the illustrated embodiment, the first end 108 of the frame 102 is the inflow end and the second end 110 of the frame 102 is the outflow end. In other embodiments, the first end 108 of the frame 102 can be the outflow end and the second end 110 of the frame 102 can be the inflow end.

[0033] The frame 102 may be made from any of a variety of suitable materials, including biocompatible metals and / or biocompatible polymers. Examples of biocompatible metals from which the frame can be formed include stainless steel, cobalt-chromium alloy, and / or nickel-titanium alloy (also known as "NiTi" or "nitinol").

[0034] 3, the frame 102 includes a plurality of interconnected struts 112 arranged in a lattice-type pattern. In FIG. 3, the frame 102 of the prosthetic valve 100 is in a radially expanded configuration, which results in the struts 112 of the frame 102 extending diagonally relative to the longitudinal axis of the prosthetic valve 100. In other configurations, the struts 112 of the frame 102 may be offset by amounts different from those shown in FIG. 3. For example, FIG. 4 shows the frame 102 of the prosthetic valve 100 in a radially compressed configuration. In this configuration, the struts 112 of the frame 102 extend parallel (or at least substantially parallel) to the longitudinal axis of the prosthetic valve 100.

[0035] To facilitate transitions between these expanded and compressed configurations, the struts 112 of the frame 102 are pivotally coupled to one another at one or more pivot joints along the length of each strut. For example, each strut 112 can be formed with apertures at both ends and along the length of the strut. The frame 102 includes hinges where the struts 112 overlap and are pivotally coupled together by fasteners, such as rivets or pins 114, that extend through the apertures in the struts 112. These hinges allow the struts 112 to pivot relative to one another as the frame 102 transitions between the radially expanded and radially compressed configurations, such as during assembly, preparation, and / or implantation of the prosthetic valve 100.

[0036] In some embodiments, the frame 102 can be fabricated by forming each component (e.g., the struts 112 and pins 114 of the frame 102) and then mechanically assembling and coupling these components together. In other embodiments, the struts are not coupled to each other with hinges but are otherwise pivotable or bendable relative to each other, allowing the frame to radially expand and contract. For example, the frame can be formed (e.g., by laser cutting, electroforming, or physical vapor deposition) from a single piece of material (e.g., a metal tube). Further details regarding the fabrication of these frames and prosthetic valves are described in U.S. Patent Nos. 6,213,249; 6,213,249; 6,213,249; and International Patent Application Publication Nos. 6,213,249 and 6,213,249, which are incorporated herein by reference. Further examples of expandable prosthetic valves that can be used with the delivery devices disclosed herein are described in U.S. Patent Nos. 6,213,249; 6,213,249; and 6,213,249, which are incorporated herein by reference.

[0037] 2 , the valve structure 104 of the prosthetic valve 100 is coupled to the frame 102. The valve structure 104 is configured to allow blood flow through the prosthetic valve 100 from the inflow end 108 to the outflow end 110 and to restrict blood from passing through the prosthetic valve 100 from the outflow end 110 to the inflow end 108. The valve structure 104 can comprise, for example, a leaflet assembly including one or more leaflets 116 (e.g., three leaflets in the illustrated embodiment).

[0038] The leaflets 116 of the prosthetic valve 100 may be made from a flexible material. For example, the leaflets 116 of the leaflet assembly may be made entirely or partially from a biological material, a biocompatible synthetic material, or other such material. Suitable biological materials may include, for example, bovine pericardium (or pericardium from other sources).

[0039] 2, the leaflets 116 can be configured to form commissures 118 (e.g., adjacent leaflet pairs), which can be attached, for example, to respective actuators 106. Further details regarding prosthetic heart valves, including the manner in which the valve structure 104 can be coupled to the frame 102 of the prosthetic valve 100, can be found in U.S. Patent Nos. 6,275,929; ... and 6,275,929, which are incorporated herein by reference.

[0040] The valve structure 104 may be coupled to the actuator 106. For example, the commissures 118 of the valve structure 104 may be coupled to a housing member 122 of the actuator 106. Further details regarding coupling the valve structure to the actuator may be found, for example, in International Patent Application Publication No. WO 2006 / 024990.

[0041] As shown in FIG. 3 , the actuators 106 of the prosthetic valve 100 are attached to and circumferentially spaced apart from an inner surface of the frame 102. The actuators 106 are configured, among other things, to radially expand and / or radially compress the frame 102. As such, the actuators 106 may also be referred to as "expansion mechanisms." The actuators 106 are also configured to lock the frame 102 in a desired expanded configuration. As such, the actuators 106 may also be referred to as "lockers" or "locking mechanisms." As described further below, each actuator 106 may be configured to form a releasable connection with one or more respective actuation shafts of a delivery device.

[0042] 5-6 , each actuator 106 includes a rack member 120 (which may also be referred to as an “actuation member”), a housing member 122 (which may also be referred to as a “support member”), and a locking member 124. The rack member 120 may be coupled to the frame 102 of the prosthetic valve 100 at a first axial location (e.g., near the inflow end 108 of the frame 102), and the housing member 122 may be coupled to the frame at a second axial location (e.g., near the outflow end 110 of the frame 102). The rack member 120 extends through each housing member 122 and is axially movable relative to each housing member 122. Thus, relative axial movement between the rack member 120 and the housing member 122 applies an axial force to the frame 102, causing the struts 112 of the frame 102 to rotate relative to each other about the pins 114, resulting in radial expansion / compression of the frame 102. Moving the rack member 120 proximally (e.g., upward in the orientation shown in FIGS. 5-6) relative to the housing member 122 radially expands the frame 102 (e.g., FIG. 3). In contrast, moving the rack member 120 distally (e.g., downward in the orientation shown in FIGS. 5-6) relative to the housing member 122 radially compresses the frame 102 (e.g., FIG. 4).

[0043] 6 , one or more of the rack members 120 include a segment having a plurality of teeth 126. Each locking member 124 is coupled to a respective housing member 122 and includes a pawl 128 biased to engage the teeth 126 of the rack member 120. In this manner, the rack members 120 and the locking members 124 form a ratchet-type mechanism that allows the rack member 120 to move proximally relative to the housing member 122 (thereby allowing expansion of the prosthetic valve 100) and restricts the rack member 120 from moving distally relative to the housing member 122 (thereby restricting compression of the prosthetic valve 100).

[0044] In the illustrated embodiment, the locking member 124 is integrally formed as a unitary structure with the housing member 122. In other embodiments, the locking member 124 and the housing member 122 may be formed as separate components that are joined together (e.g., with fasteners, adhesives, welding, and / or other joining means).

[0045] In the illustrated embodiment, the prosthetic valve 100 includes three actuators 106. In other embodiments, more or fewer actuators may be used. For example, in one embodiment, the prosthetic valve may have one actuator. As another example, the prosthetic valve may have two actuators. In yet another example, the prosthetic valve may have between four and fifteen actuators.

[0046] Although not shown, the prosthetic valve 100 may also include one or more skirts or sealing members. For example, the prosthetic valve 100 may include an inner skirt attached to the inner surface of the frame 102. The inner skirt may function as a sealing member to prevent or reduce paravalvular regurgitation, to secure the leaflets 116 to the frame 102, and / or to protect the leaflets 116 from damage caused by contact with the frame 102 during crimping and the work cycle of the prosthetic valve 100. The prosthetic valve 100 may also include an outer skirt attached to the outer surface of the frame 102. The outer skirt may function as a sealing member for the prosthetic valve by sealing against the tissue of the native annulus, thereby reducing paravalvular regurgitation around the prosthetic valve. The inner and outer skirts may be formed from any of a variety of suitable biocompatible materials, including any of a variety of synthetic materials (e.g., PET) or natural tissue (e.g., pericardial tissue). The inner and outer skirts may be attached to the frame using sutures, adhesives, welding, and / or other means for attaching the skirts to the frame.

[0047] 7-10 illustrate a delivery device 200 and its components, which may also be referred to as a "valve catheter" or "delivery catheter." As shown, the delivery device 200 includes a handle 202, a first shaft 204, a second shaft 206, one or more support sleeves 208 (e.g., three in the illustrated embodiment), one or more actuation shafts 210 (e.g., three in the illustrated embodiment), an optional recompression shaft 212, a nosecone shaft 214, and a nosecone 216. The handle 202 is configured to manipulate the shafts and sleeves relative to one another. The prosthetic heart valve 100 is releasably coupled to a distal end portion of the delivery device 200 (see, e.g., FIGS. 11-13 ), and the delivery device 200 may be used to position the prosthetic valve 100 and / or to expand, compress, and lock the prosthetic valve 100 in a desired radially expanded configuration.

[0048] In the illustrated embodiment, the delivery device 200 includes three pairs of support sleeves 208 and actuation shafts 210 (i.e., one pair of support sleeves 208 and actuation shafts 210 for each actuator 106 of the prosthetic valve 100). In other embodiments, the delivery device 200 can include two or fewer (e.g., one or two) or four or more (e.g., four to fifteen) pairs of support sleeves 208 and actuation shafts 210, depending on the number of actuators included in the prosthetic valve.

[0049] The handle 202 of the delivery device 200 includes one or more mechanisms configured to move the shaft and sleeve relative to one another. For example, as shown in FIG. 7 , the handle 202 includes a first mechanism 218, a second mechanism 220, a third mechanism 222, and / or a fourth mechanism 224.

[0050] The first mechanism 218 of the handle 202 is coupled to the first shaft 204 and the second shaft 206 and is configured to axially move the first shaft 204 and the second shaft 206 relative to one another. As described further below, the first mechanism 218 of the handle 202 may be used to deploy the prosthetic valve 100 from a delivery capsule on the first shaft 204 (see FIG. 7 ). As such, the first mechanism 218 may be referred to as a “deployment mechanism.”

[0051] In the illustrated embodiment, the first mechanism 218 includes a first knob 226 configured to actuate the first mechanism 218. Although not shown, in other embodiments, the first mechanism 218 can include various other types of actuators configured to actuate the first mechanism 218, such as a button, a switch, etc. The first mechanism 218 can also include one or more other components (e.g., an electric motor, a rotatable shaft, a drive screw, a gear assembly, etc.) configured to facilitate and / or limit relative axial movement between the first shaft 204 and the second shaft 206. For example, the first mechanism 218 can be configured such that rotating the first knob 226 (and / or the electric motor) relative to the housing 228 of the handle 202 results in relative axial movement between the first shaft 204 and the second shaft 206.

[0052] The second mechanism 220 of the handle 202 is coupled to the actuation shaft 210 and is configured to axially move the actuation shaft 210 relative to the support sleeve 208. When the prosthetic valve 100 is coupled to the delivery device 200 via the actuation shaft 210, the second mechanism 220 of the handle 202 may be used to radially expand and / or compress the prosthetic valve 100, as described further below. Accordingly, the second mechanism 220 may be referred to as an "actuation mechanism" and / or an "expansion mechanism."

[0053] In the illustrated embodiment, the second mechanism 220 includes a second knob 230 configured to actuate the second mechanism 220. In other embodiments, the second mechanism 220 can include various other types of actuators. Also, although not shown, the second mechanism 220 can further include one or more additional components configured to facilitate and / or limit relative axial movement of the actuation shaft 210 with respect to the support sleeve 208. For example, the second mechanism 220 can include an electric motor, a drive screw, a gear assembly, and / or other components. In some embodiments, the second mechanism 220 can be configured such that rotating the second knob 230 (and / or the electric motor) relative to the handle housing 228 results in relative axial movement of the actuation shaft 210 and the support sleeve 208.

[0054] Additionally, a third mechanism 222 of the handle 202 is coupled to the actuation shaft 210 and is configured to rotate the actuation shaft 210 relative to the support sleeve 208. In this manner, the third mechanism 222 may be used to simultaneously couple and release the actuation shaft 210 to and from the prosthetic valve 100, as described further below. Thus, the third mechanism 222 may be referred to as a "release mechanism" or a "coupling mechanism."

[0055] In the illustrated embodiment, the third mechanism 222 includes a third knob 232 configured to actuate the third mechanism 222. In other embodiments, the third mechanism 222 can include various other types of actuators. The third mechanism 222 can also include one or more other components (e.g., a gear assembly and / or an electric motor) configured to facilitate and / or limit relative rotational movement between the actuation shaft 210 and the support sleeve 208. For example, the third mechanism 222 can be configured such that rotating the third knob 232 relative to the housing 228 results in rotation of the actuation shaft 210 relative to the support sleeve 208.

[0056] A fourth mechanism 224 of the handle 202 is coupled to the nosecone shaft 214 and configured to axially move the nosecone shaft 214 and the nosecone 216 relative to the first shaft 204 and second shaft 206. As such, the fourth mechanism 224 may be referred to as a “nose cone mechanism.”

[0057] In the illustrated embodiment, the fourth mechanism 224 comprises a slider 234 configured to actuate the fourth mechanism 224. Although not shown, the fourth mechanism 224 can comprise various other components configured to facilitate and / or limit relative axial movement of the nosecone shaft 214 and the first and second shafts 204, 206. For example, in some embodiments, the fourth mechanism 224 can comprise one or more biasing members (e.g., springs) configured to bias the nosecone shaft 214 to a predetermined axial position relative to the first and second shafts 204, 206. In such embodiments, the slider 234 can be biased to a particular axial position (e.g., a proximal position) relative to the housing 228. The nosecone shaft 214 can be moved axially relative to the first and second shafts 204, 206 by sliding the slider 234 relative to the housing 228 with sufficient force to overcome the resisting force of the biasing members. When released, the slider 234 may return to the biased position. In other embodiments, the fourth mechanism may include a rotatable knob, an electric motor, and / or a drive screw configured to translate relative rotational movement between the knob (and / or motor) and the housing into relative axial movement between the nosecone shaft and the first and second shafts.

[0058] 7-8 , a proximal end portion of a first shaft 204 is coupled to and extends distally from a handle 202. The first shaft 204 includes a lumen for accommodating a second shaft 206 of the delivery device 200. The distal end portion of the first shaft 204 is configured to receive the prosthetic valve 100 in a radially compressed configuration (see FIGS. 14-17 ). As such, the first shaft 204 may also be referred to as a “sheath” or a “delivery capsule.” Alternatively, the delivery capsule can be a separately formed component coupled to the distal end portion of the first shaft 204.

[0059] As shown in FIGS. 8-9 , the second shaft 206 extends coaxially through the first shaft 204 and is axially movable relative to the first shaft 204. The second shaft 206 includes multiple lumens extending axially therethrough and may therefore be referred to as a "multi-lumen shaft." For example, as shown in FIG. 9 , the second shaft 206 includes one or more first lumens 236 (e.g., three in the illustrated embodiment) circumferentially spaced apart from one another. The first lumens 236 may be configured to receive respective actuation shafts 210 and / or support sleeves 208. In the illustrated embodiment, the first lumens 236 are uniformly spaced apart from one another (i.e., spaced apart by approximately 120 degrees). In other embodiments, the first lumens 236 may be non-uniformly spaced apart from one another.

[0060] In some embodiments, second shaft 206 can further include one or more additional lumens. For example, as shown in FIG. 9 , second shaft 206 includes a recompression lumen 238 and a guidewire lumen 240. Guidewire lumen 240 can be radially centrally disposed within second shaft 206. Recompression lumen 238 can be radially outwardly disposed relative to guidewire lumen 240. In some embodiments, recompression lumen 238 can be radially aligned with and / or circumferentially spaced apart from first lumen 236.

[0061] The support sleeve 208 may extend distally from the first lumen 236 of each of the second shafts 206 and be configured to contact the actuator 106 of the prosthetic valve 100 (see FIG. 12 ). The support sleeve 208 may have a relatively higher stiffness than the actuation shaft 210. As such, the support sleeve 208 may be used to apply a distal force to the housing member 122 of the actuator 106 that may counteract the proximal force applied by the actuation shaft 210 of the delivery device 200 to the rack member 120 of the actuator 106, thereby enabling expansion of the prosthetic valve 100 caused by relative axial movement between the rack member 120 of the actuator 106 and the housing member 122.

[0062] In the illustrated embodiment, the support sleeves 208 are relatively short tubes that are coupled to distal end portions of the second shafts 206 but do not extend the entire length of the second shafts 206 through the handle 202. The sleeves 208 may, in some instances, be secured (e.g., with an adhesive) to the inner surface of the second shafts 206 that defines the first lumens 236. In some embodiments, the proximal end portions of the support sleeves 208 are coupled to the handle 202, and the support sleeves 208 may extend through the respective first lumens 236 of the second shafts 206 and beyond the distal end of the second shafts 206. In either instance, each support sleeve 208 includes a lumen configured to receive a respective actuation shaft 210, as shown in FIG. 9 .

[0063] The actuation shaft 210 may extend distally from the handle 202 through the first lumen 236 of each of the second shafts 206 and through the lumen of the respective support sleeve 208. The distal end portion of the actuation shaft 210 may include a mating feature configured to releasably couple the actuation shaft to the actuator 106 of the prosthetic valve 100. For example, as shown in FIGS. 10-12 , the distal end portion of the actuation shaft 210 includes an externally threaded portion 242 configured to mate with a corresponding internally threaded portion 130 of the rack member 120 of the actuator 106.

[0064] In some embodiments, actuation shaft 210 can be a relatively flexible member. For example, actuation shaft can be a wire, cable, cord, suture, etc. In other embodiments, actuation shaft can be a relatively rigid member, such as a rod. In other embodiments, actuation shaft 210 can include one or more relatively flexible segments (e.g., located at the distal end portion) and one or more relatively rigid segments (e.g., located at the proximal end portion).

[0065] Referring to Figure 8, the recompression shaft 212 extends from the handle 202 through the recompression lumen 238 of the second shaft 206. As shown in Figure 9, the recompression shaft 212 includes a lumen 244 through which a recompression member 246 (e.g., a wire, cable, suture, etc.) extends. As shown in Figure 13, the recompression member 246 may extend around the prosthetic valve 100 in a lasso-like manner. As such, the recompression member 246 may be used to recompress the prosthetic valve 100 by applying tension to the recompression member 246 around the prosthetic valve 100, thereby tightening it.

[0066] The prosthetic valve 100 may be coupled to a distal end portion of a delivery device 200 to form a delivery assembly (see FIGS. 11-13). Furthermore, the delivery device 200 may be used to implant the prosthetic valve 100 within a patient (see FIGS. 13-19). The prosthetic valve 100 may be coupled to the delivery device 200 by positioning the delivery device 200 in the configuration shown in FIG. 8. As shown in FIG. 13, with the prosthetic valve 100 in a radially expanded configuration, the prosthetic valve 100 may be positioned over the proximal portion of the nosecone 216 and the nosecone shaft 214, and optionally within the loop of the recompression member 246. The actuator 106 of the prosthetic valve 100 may be positioned adjacent to the distal end of the actuation shaft 210, as shown in FIG. 11. The actuation shaft 210 may then be inserted into the housing member 122 of the actuator 106 and threaded onto the rack member 120 of the actuator 106, as shown in FIG. 12.

[0067] With the prosthetic valve 100 releasably coupled to the delivery device 200 (see FIG. 13 ), the prosthetic valve 100 can be radially compressed by actuating the actuator 106, applying tension to the recompression member 246, and / or inserting the prosthetic valve 100 and delivery device 200 into a crimping device. Further details regarding an example crimping device for a mechanically expandable prosthetic valve can be found in International Patent Application Publication No. 2004 / 002499, which is incorporated herein by reference. FIG. 14 shows the prosthetic valve 100 in a radially compressed configuration. Then, as shown in FIG. 15 , the first shaft 204 of the delivery device 200 is advanced over the second shaft 206 of the delivery device 200 and the prosthetic valve 100 so that the prosthetic valve 100 is disposed within the lumen of the first shaft 204, and the distal end of the first shaft 204 can abut the nosecone 216. This can be accomplished, for example, by actuating the first mechanism 218 of the handle 202.

[0068] The distal end portion of the delivery assembly 10 may then be inserted into the patient's vasculature and the prosthetic valve 100 may be advanced to an implantation location using the delivery device 200. For example, Figures 16-19 illustrate one example implantation technique for implanting the prosthetic valve 100 within a patient's heart 300 utilizing a transfemoral delivery technique. In other embodiments, a variety of other delivery techniques may be utilized, such as transventricular, transapical, transseptal, etc.

[0069] 16 , the distal end portion of the delivery assembly 10 is inserted into the patient's vasculature such that the first shaft 204 extends through the patient's aorta 302 and the nosecone 216 extends through the patient's native aortic valve annulus 304 and into the left ventricle 306 of the patient's heart 300. With reference to FIG. 17 , the prosthetic valve 100 may be deployed from the first shaft 204 of the delivery device 200 by actuating the first mechanism 218 of the handle 202, thereby moving the first shaft 204 of the delivery device 200 proximally relative to the second shaft 206 of the delivery device 200 (and / or moving the second shaft 206 distally relative to the first shaft 204). The first shaft 204 may be further moved proximally such that the support sleeve 208 is exposed from the distal end of the first shaft 204 (see, e.g., FIG. 14 ).

[0070] 18 , the prosthetic valve 100 may then be radially expanded. This may be accomplished, for example, by actuating the second mechanism 220 of the handle 202 to move the actuation shaft 210 and rack member 120 of the actuator 106 (coupled to the actuation shaft 210) proximally relative to the support sleeve 208 and housing member 122 of the actuator 106 (which abuts the distal end of the support sleeve 208). Once the prosthetic valve 100 is positioned and secured within the native aortic valve annulus 304 as desired, the locking member 124 may engage the rack member 120 to hold the prosthetic valve 100 in the expanded state.

[0071] If repositioning of the prosthetic valve is desired, the second mechanism 220 can be used to actuate the actuator 106 to radially compress the prosthetic valve 100. Alternatively, or in addition to using the second mechanism 220, the prosthetic valve 100 can be recompressed and repositioned and / or retrieved using a recompression member 246. In some instances, the recompression member 246 can radially compress the prosthetic valve to a smaller diameter than would be possible using the actuator 106 alone. Note that for illustration purposes, the recompression shaft 212 and recompression member 246 are not shown in FIGS. 17-18 , and the nosecone shaft 214 and nosecone 216 are not shown in FIGS. 18-19 .

[0072] Once expanded and secured, the prosthetic valve 100 may then be released from the delivery device 200, as shown in FIG. 19 . This may be achieved by actuating the third mechanism 222 of the handle 202, which rotates the actuation shaft 210 of the delivery device 200 relative to the rack member 120 of the prosthetic valve 100, thereby disengaging the threaded portion 242 of the actuation shaft 210 from the threaded portion 130 of the rack member 120. The actuation shaft 210, support sleeve 208, and second shaft 206 may then be retracted back into the first shaft 204, and the delivery device 200 may be removed from the patient's body.

[0073] During an implantation procedure, the delivery device is advanced through the patient's vasculature. The patient's vasculature may include various curves, including some relatively sharp curves, such as the natural aortic arch (see FIGS. 16-19). When the delivery device is curved, some of the shafts of the delivery device follow a different path length than other shafts of the delivery device. The path lengths of the shafts may vary depending on their radial distance from a neutral axis. For example, in the case of delivery device 200, the central longitudinal axes of first shaft 204 and second shaft 206 form the neutral axis. Therefore, the first shaft 204 and second shaft 206 follow the same length when extending through a curve because the first shaft 204 and second shaft 206 are coaxial and concentric. As shown in FIG. 9, the actuation shaft 210 is spaced radially outward from the central longitudinal axes of the first shaft 204 and second shaft 206. In other words, the actuation shaft 210 is non-coaxial and eccentric with the first shaft 204 and the second shaft 206. As a result, when the delivery device 200 is disposed over a curve, each actuation shaft 210 follows a different path length. If all of the actuation shafts 210 had the same length, the different path lengths could result in uneven tension and / or stretching of the actuation shafts 210. Uneven tension and / or stretching of the actuation shafts 210 is undesirable because it results in uneven force distribution across the actuation shafts and / or uneven displacement of the actuation shafts. Uneven forces in the actuation cables can result in excessive force on one or more of the actuation shafts 210, which in some instances can cause damage to the actuator 106 and / or the actuation shafts 210. For example, uneven displacement of the actuation cables can result in uneven radial expansion of the prosthetic heart valve. It is therefore desirable to reduce or prevent non-uniform forces and / or non-uniform displacements in these actuation shafts.

[0074] Disclosed herein are various control mechanisms and multi-lumen shafts configured to control the force and / or displacement of the actuation shaft, even when the actuation shaft is bent. In some examples, these control mechanisms may be coupled to the expansion mechanism and / or release mechanism of the delivery device. The disclosed control mechanisms may be effective, for example, to evenly distribute load on the actuation shaft. Additionally or alternatively, the disclosed control mechanisms may adjust the lengths of the actuation shafts relative to one another to ensure even expansion of the prosthetic valve when the expansion mechanism is activated. The disclosed control mechanisms may be used, for example, with delivery device 200.

[0075] Generally, the control mechanisms of the present disclosure operate by allowing one end of the actuation shaft (e.g., the proximal end portion) to move relative to other components of the delivery device, rather than having both ends of the actuation shaft fixed. In this way, the actuation shaft is allowed to "float" when the delivery device is bent, thereby preventing uneven tension and / or stretch in the actuation shaft.

[0076] In some embodiments, the control mechanism can be a force control mechanism for the delivery device. The force control mechanism can be configured to evenly distribute the force applied to the actuation shaft of the delivery device. In some embodiments, the force control mechanism can include a pulley system. The pulley system can include one or more pulleys interconnected to the actuation shaft. The pulleys allow proximal end portions of the actuation shafts to move relative to one another, thereby evenly distributing the load of the actuation shaft. In some embodiments, the force control mechanism can be coupled to the actuation mechanism of the delivery device.

[0077] In some embodiments, the control mechanism can be a displacement control mechanism for the delivery device. In certain embodiments, the displacement control mechanism can include one or more gear assemblies coupled to an actuation shaft of the delivery device. These gear assemblies can be configured to axially and / or rotationally move the actuation shaft relative to other components of the delivery device and / or the prosthetic heart valve. In this manner, the displacement mechanism can be used, for example, to expand the prosthetic heart valve and / or release the prosthetic heart valve from the delivery device. In certain embodiments, the displacement control mechanism can be coupled to an actuation mechanism and / or a release mechanism of the delivery device.

[0078] In other embodiments, a multi-lumen shaft may be provided that includes multiple spiral lumens. These spiral lumens may be configured to receive respective actuation shafts of a delivery device. For example, the spiral lumens may be effective in ensuring that the actuation shafts travel the same or substantially the same distance even when the multi-lumen shaft is bent. Thus, the multi-lumen shafts disclosed herein may be effective in ensuring, for example, uniform valve expansion.

[0079] In some examples, the delivery device can have a force control mechanism, a displacement control mechanism, and / or a multi-lumen shaft with a helical lumen. In other examples, the delivery device can include a force control mechanism but omit a displacement control mechanism and / or a multi-lumen shaft with a helical lumen. In still other embodiments, the delivery device can include various other combinations and / or subcombinations of force control mechanisms, displacement control mechanisms, and / or a multi-lumen shaft with a helical lumen.

[0080] 20 illustrates a force control mechanism 400, according to one embodiment. As shown, in some instances, the force control mechanism 400 can be a component of the delivery device 200. In some such instances, the force control mechanism can be housed within the handle 202 of the delivery device 200, for example. The force control mechanism 400 can be coupled to and disposed between the actuation shaft 210 and the actuation mechanism 220. In this manner, the force control mechanism 400 can be used to evenly distribute forces in and / or applied to the actuation shaft 210.

[0081] The force control mechanism 400 includes a plurality of pulleys coupled to the actuation shaft 210 and the actuation mechanism 220. One or more of the pulleys may be disposed on a movable carriage on which they may be disposed such that the pulleys are movable relative to the housing 228 of the handle 202, and one or more of the pulleys may be coupled to the housing 228 of the handle 202 such that they are stationary relative to the housing 228.

[0082] More specifically, the force control mechanism 400 includes a first dynamic pulley 402, a second dynamic pulley 404, a static pulley 406, a carriage 408, and a base member 410. The first dynamic pulley 402 and the second dynamic pulley 404 are rotatably coupled to the carriage 408. The static pulley 406 is rotatably coupled to the base member 410, which is fixedly coupled to the housing 228 of the handle 202.

[0083] In the illustrated embodiment, the force control mechanism 400 further includes a first connecting member 412 and a second connecting member 414. The first connecting member 412 and the second connecting member 414 can be flexible cords, wires, cables, sutures, or the like. The first connecting member 412 extends around the first dynamic pulley 402, with a first end portion 412a coupled to the proximal end portion of the first actuation shaft 210a and a second end portion 412b coupled to the proximal end portion of the second actuation shaft 210b. The second connecting member 414 extends around the second dynamic pulley 404 and the static pulley 406, with a first end portion 414a coupled to the proximal end portion of the third actuation shaft 210c and a second end portion 414b coupled to the actuation mechanism 220.

[0084] In other embodiments, the force control mechanism may not have these linking members. In such embodiments, the first actuation shaft 210a and the second actuation shaft 210b may be integrally formed or directly coupled together. Also, the third actuation shaft 210c may be directly coupled to the actuation mechanism 220.

[0085] The carriage 408 is axially movable relative to the housing 228 of the handle 202. For example, the carriage 408 can be slidably coupled to the housing 228 such that the carriage 408 can move axially relative to the housing 228. In some embodiments, the carriage 408 can be coupled to the housing 228 via a track 416 configured to facilitate relative axial movement between the carriage 408 and the housing 228. In some examples, friction-reducing elements (e.g., bearings, wheels, rollers, lubricant, slippery material, etc.) can be disposed between the carriage 408, the track 416, and / or the housing 228 to help the carriage 408 move more easily relative to the track 416 and / or the housing 228.

[0086] In operation, the proximal end portions of the first actuation shaft 210a and the second actuation shaft 210b are free to move axially relative to each other via the first coupling member 412 and the first dynamic pulley 402. Therefore, any difference in force (e.g., tension) between the first actuation shaft 210a and the second actuation shaft 210b is balanced by the axial movement of the proximal end portions of the first actuation shaft 210a and the second actuation shaft 210b relative to each other. Additionally, the proximal end portion of the third actuation shaft 210c is free to move axially relative to the proximal end portions of the first actuation shaft 210a and / or the second actuation shaft 210b via the second coupling member 414, the second dynamic pulley 404, the static pulley 406, and the carriage 408. Therefore, the difference in force between the third actuation shaft 210c and the first actuation shaft 210a and / or the second actuation shaft 210b is balanced by the axial movement of the proximal end portions of the actuation shafts 210 relative to each other.

[0087] Additionally, when the actuation mechanism 220 is actuated to expand the prosthetic valve 100 and tension builds in the second connecting member 414, the force control mechanism 400 allows the proximal end portions of the actuation shafts 210 to move axially relative to one another, thereby evenly distributing the tension acting on the second connecting member 414 among the actuation shafts 210. For example, as shown in FIG. 20 , the proximal end portion of each actuation shaft 210 is located at a different axial position relative to the handle 202.

[0088] Uniform force distribution among the actuation shafts can be effective in ensuring that none of the actuation shafts experiences excessive loads that could result in uneven expansion of the prosthetic valve and / or damage to the actuation shaft (e.g., damage to the threads 242 located at the distal end portion of the actuation shaft 210). As a result, for example, the force control mechanism can improve the functionality, safety, and / or reliability of the delivery device.

[0089] 21 shows a portion of a delivery device 500 according to another embodiment. The delivery device 500 includes a handle 502 and multiple actuation shafts 504a-504d (collectively or collectively "actuation shafts 504"). The delivery device 500 also includes a force control mechanism 506 and an actuation mechanism 508. The actuation shaft 504 is coupled to the handle 502 via the force control mechanism 506 and the actuation mechanism 508. The force control mechanism 506 and the actuation mechanism 508 are configured substantially similarly to the force control mechanism 400 and the actuation mechanism 220, respectively, except that the force control mechanism 506 is configured to balance the forces of four actuation shafts instead of three.

[0090] In the illustrated embodiment, the force control mechanism 506 of the delivery device 500 includes a first dynamic pulley 510, a second dynamic pulley 512, a third dynamic pulley 514, a fourth dynamic pulley 516, a static pulley 518, a first carriage 520, a second carriage 522, a first linkage member 524, a second linkage member 526, a third linkage member 528, a base member 530, and an anchor 532. The first dynamic pulley 510 and the second dynamic pulley 512 are rotatably mounted to the first carriage 520, which is movably coupled to the handle 502. The third dynamic pulley 514 and the fourth dynamic pulley 516 are rotatably mounted to the second carriage 522, which is also movably coupled to the handle 502. The static pulley 518 is rotatably mounted to a base member 530, which is fixedly coupled to the handle 502. A first coupling member 524 extends around the first dynamic pulley 510 and has a first end portion coupled to the proximal end portion of the first actuation shaft 504a and a second end portion coupled to the proximal end portion of the second actuation shaft 504b. A second coupling member 526 extends around the third dynamic pulley 514 and has a first end portion coupled to the proximal end portion of the third actuation shaft 504c and a second end portion coupled to the proximal end portion of the fourth actuation shaft 504d. A third coupling member 528 extends from the actuation mechanism 508, around the second dynamic pulley 512, around the static pulley 518, around the fourth dynamic pulley 516, to the anchor 532. Anchor 532 is fixedly coupled to handle 502 .

[0091] The first coupling member 524 and the first dynamic pulley 510 allow the proximal end portions of the first and second actuation shafts 504a, 504b to move axially relative to each other, thereby evenly distributing forces between the first and second actuation shafts 504a, 504b. The second coupling member 526 and the third dynamic pulley 514 allow the proximal end portions of the third and fourth actuation shafts 504c, 504d to move axially relative to each other, thereby evenly distributing forces between the third and fourth actuation shafts 504c, 504d. The third coupling member 528, the second and fourth dynamic pulleys 512, 516, the static pulley 518, and the anchor 532 allow the first and second carriages 520, 522 to move axially relative to one another, which in turn allows the proximal end portions of the first and second actuation shafts 504a, 504b to move axially relative to the proximal end portions of the third and fourth actuation shafts 504c, 504d, thereby evenly distributing forces among all of the actuation shafts 504.

[0092] In other embodiments, the force control mechanism 506 may not have a linkage, and the actuation shafts may be directly coupled together and / or to other components of the delivery device 500.

[0093] 22 shows a portion of a delivery device 600 according to another embodiment. The delivery device 600 includes a handle 602 and multiple actuation shafts 604a-604e (collectively or collectively "actuation shafts 604"). The delivery device 600 also includes a force control mechanism 606 and an actuation mechanism 608, where the actuation shaft 604 is coupled to the handle 602 via the force control mechanism 606 and the actuation mechanism 608. The force control mechanism 606 and the actuation mechanism 608 are configured similarly to the force control mechanism 400 and the actuation mechanism 220, respectively, except that the force control mechanism 606 is configured to balance the forces of five actuation shafts instead of three.

[0094] The force control mechanism 606 includes a plurality of dynamic pulleys 610 (e.g., four in the illustrated embodiment (610a-610d)), a plurality of static pulleys 612 (e.g., two in the illustrated embodiment (612a-612b)), a plurality of carriages 614 (e.g., two in the illustrated embodiment (614a-614b)), and a plurality of linkage members 616 (e.g., three in the illustrated embodiment (616a-616c)).

[0095] These components of force control mechanism 606 cooperate to allow the proximal end portions of actuation shafts 604 to move axially relative to one another in a manner similar to that described above in connection with force control mechanisms 400 and 506. As a result, forces are evenly distributed between actuation shafts 604.

[0096] Force control mechanisms 400, 506, and 606 are configured for delivery devices having three, four, or five actuation shafts, respectively. In other embodiments, the force control mechanisms may be configured for use with delivery devices having two or fewer (e.g., two) or six or more (e.g., six to fifteen) actuation shafts.

[0097] 23 illustrates a displacement control mechanism 700. As shown, in some examples, the displacement control mechanism 700 can be used with the delivery device 200. In particular, the displacement control mechanism 700 allows all of the actuation shafts 210 to be moved axially simultaneously (e.g., to expand a prosthetic valve). The displacement control mechanism 700 also allows all of the actuation shafts to be released simultaneously (e.g., when decoupling a prosthetic valve from a delivery device). Furthermore, the displacement control mechanism 700 allows the proximal end portions of the actuation shafts of the delivery device to move axially relative to each other when the actuation shafts follow different path lengths (e.g., when the actuation shafts bend at a bend).

[0098] In the illustrated embodiment, the displacement control mechanism 700 comprises three main components: a coupling member 702, an actuation member 704, and a gear assembly 706. The coupling member 702 of the displacement control mechanism 700 is disposed near a distal end portion of the shaft 206 of the delivery device 200 and is coupled to the actuation shaft 210 of the delivery device 200. Note that the shaft 206 is shown as transparent for illustrative purposes. The actuation member 704 of the displacement control mechanism 700 extends through the shaft 206 and is coupled to the coupling member 702 of the displacement control mechanism 700 at the distal end of the actuation member 704 and to the actuation mechanism 220 of the delivery device 200 at the proximal end of the actuation member 704. The gear assembly 706 of the displacement control mechanism 700 is disposed within the handle 202 of the delivery device 200 and is coupled to the proximal end portion of the actuation shaft 210 and to the release mechanism 222 of the delivery device 200. In this manner, axial movement of actuation member 704 relative to shaft 206 causes coupling member 702 and actuation shaft 210 to move axially (e.g., to expand the prosthetic valve), and rotational movement of gear assembly 706 relative to shaft 206 causes actuation shaft 210 to rotate (e.g., to release the prosthetic valve from delivery device 200). Further details regarding displacement control mechanism 700 and its components are presented below.

[0099] 24, the coupling member 702 of the displacement control mechanism 700 comprises a cylindrical or disk-shaped body. In other embodiments, the coupling member may comprise a variety of other shapes (e.g., a cube, a prism, etc.).

[0100] The coupling member 702 has a plurality of openings 708 extending axially therethrough. As shown in FIG. 26 , the openings 708 in the coupling member 702 are configured to allow the actuation shaft 210 to extend therethrough and rotate freely relative to the coupling member 702.

[0101] 26 , a plurality of stop members 170 are provided to limit relative axial movement between the coupling member 702 and the actuation shaft 210. The stop members 710 are fixedly coupled (e.g., by fasteners, adhesive, welding, frictional engagement, etc.) to the actuation shaft 210 adjacent the proximally and distally facing surfaces of the coupling member 702. The stop members 710 are radially larger than the openings 708 in the coupling member 702. As a result, the stop members 710 abut the proximally and distally facing surfaces of the coupling member 702, thus limiting the relative axial movement between the actuation shaft 210 and the coupling member 702.

[0102] As shown in Figures 25-26, a distal end portion of the actuation member 704 is coupled to the coupling member 702. Thus, axial movement of the actuation member 704 results in axial movement of the coupling member 702 and, therefore, the actuation shaft 210. For example, Figure 25 shows the actuation member 704, coupling member 702, and actuation shaft 210 in a proximal position where the coupling member 702 abuts the distal manifold 248 of the delivery device 200, which is shown as transparent for illustrative purposes. The manifold 248 of the delivery device 200 is coupled to the distal end portion of the shaft 206 and is used to couple the support sleeve 208 to the shaft 206. The manifold 248 also serves as a distal stop for the coupling member 702.

[0103] The actuation member 704 can be coupled to the coupling member 702 in a variety of ways, including tying, fasteners, adhesives, embedding, etc. Although not shown, in some embodiments, the coupling member 702 can include an attachment element (e.g., a bore, an opening, an eyelet, etc.) configured to facilitate attachment of the actuation member 704 to the coupling member 702.

[0104] 23 , a proximal end portion of the actuation member 704 is coupled to an actuation mechanism 220 of the handle 202. In some embodiments, the actuation mechanism 220 can include a spool or other device configured to retract and release the actuation member 704, which can be used to increase and decrease tension on the actuation member 704. The actuation mechanism 220 can have a first mode of operation that increases tension on the actuation member 704, thereby moving the actuation member 704, coupling member 702, and actuation shaft 210 proximally relative to the support sleeve 208. As such, the first mode of operation can be utilized, for example, to radially expand a prosthetic valve (e.g., prosthetic valve 100) coupled to the distal end portion of the actuation shaft 210. The actuation mechanism 220 may have a second mode of operation that reduces tension on the actuation members 704, causing (or enabling) distal movement of the actuation members 704, the coupling members 702, and the actuation shafts 210. Thus, the second mode of operation may be utilized, for example, to radially compress a coupled prosthetic valve (e.g., the prosthetic valve 100) relative to the distal end portions of the actuation shafts 210. In this manner, the displacement control mechanism 700 advantageously allows simultaneous axial movement of all of the actuation shafts 210, which in turn allows simultaneous actuation of the actuators 106 of the prosthetic valves 100. This may, for example, improve uniform expansion of the prosthetic valve.

[0105] 27-31 illustrate the gear assembly 706 and its components of the displacement control mechanism 700. Referring initially to FIGS. 30 and 31 , the gear assembly 706 includes a plurality of internal gears 712 and an external gear 714 surrounding the internal gears 712. The internal gears 712 are coupled to a proximal end portion of the actuation shaft 210. The internal gears 712 and the proximal end portion of the actuation shaft 210 may move axially relative to the external gears 714. The external gears 714 engage each of the internal gears 712 such that rotation of the external gears 714 about their central longitudinal axis results in rotation of the internal gears 712 about their respective longitudinal axes. In this manner, the gear assembly 706 may be used to simultaneously rotate each actuation shaft 210 relative to the shaft 206, such as when coupling and / or releasing a prosthetic valve from the delivery device 200.

[0106] 27-28 , each internal gear 712 includes a mounting portion 716 and a plurality of teeth 718. The mounting portion 716 can be configured to couple the internal gear 712 to a corresponding actuation shaft 210 ( FIG. 23 ). For example, in the illustrated embodiment, the mounting portion 716 of the internal gear 712 includes an axial opening 720 (or bore) configured to receive a proximal end portion of the actuation shaft 210. The mounting portion 716 also includes a radial opening 721 intersecting the axial opening 720. A fixing element 722 (e.g., a set screw) can be disposed within the radial opening 721 and adjustably (e.g., threadably) coupled to the mounting portion 716. Thus, the fixing element 722 can extend into the axial opening 720 and contact the actuation shaft 210 to limit relative movement (e.g., axial and rotational movement) between the internal gear 712 and the actuation shaft 210. Thus, axial movement of the internal gear 712 results in axial movement of the actuation shaft 210 , and rotational movement of the internal gear 712 results in rotational movement of the actuation shaft 210 .

[0107] Instead of or in addition to the axial opening 720, the radial opening 721, and / or the securing element 722, the internal gear 712 can be secured to the actuation shaft in various other ways. For example, the internal gear 712 can be secured to the actuation shaft 210 via adhesive, welding, and / or other connecting means. Additionally or alternatively, in some embodiments, each actuation shaft 210 can include a “flat” (i.e., a segment having a “D-shaped” cross-sectional profile in a plane perpendicular to the longitudinal axis of the actuation shaft). This flat of the actuation shaft can be axially aligned with the radial opening 721 of the internal gear 712 such that the securing element 722 engages the flat of the actuation shaft (rather than the circular portion of the actuation shaft), thereby providing an increased restriction on relative rotational movement between the actuation shaft and the internal gear. Additionally or alternatively, the axial openings 720 of the actuation shaft and the internal gear 712 can have corresponding non-circular cross-sectional shapes (e.g., D-shaped, square-shaped, triangular, star-shaped / gear-shaped, etc.) that can mate together to limit relative rotational movement between the actuation shaft and the internal gear.

[0108] The teeth 718 of the internal gear 712 extend radially outward from the mounting portion 716. As shown in FIG. 30 , the teeth 718 of the internal gear 712 mesh with corresponding radially inwardly directed teeth 724 of the external gear 714. The internal gear 712 of the displacement control mechanism 700 and the actuation shaft 210 of the delivery device 200 may be mounted within the handle 202 of the delivery device 200 such that the internal gear 712 and the actuation shaft 210 can rotate about their respective central axes but cannot move circumferentially (orbitally) relative to the external gear 714. Thus, rotation of the external gear 714 about its central axis relative to the handle 202 of the delivery device 200 results in rotation of the internal gear 712 and the actuation shaft 210 about their respective central axes relative to the handle 202 (and shaft 206).

[0109] The inner gear 712 has a smaller diameter than the outer gear 714, so that one rotation of the outer gear 714 about its central axis results in the inner gear 712 rotating more than one rotation about their respective central axes. By varying the relative diameters of the inner gear 712 and the outer gear 714, various gear ratios between the inner gear 712 and the outer gear 714 can be selected.

[0110] Additionally, the inner gear 712 and actuation shaft 210 may be mounted within the handle 202 of the delivery device 200 such that proximal end portions of the inner gear 712 and actuation shaft 210 may move axially relative to the outer gear 714 and relative to each other. Advantageously, this may allow the actuation shaft 210 to be adjusted to various path lengths depending on the curvature in the shaft 206 (e.g., when curving around the aortic arch). For example, FIG. 31 shows two actuation shafts 210 and inner gear 712, each located at a different axial position. When the shaft 206 is curved (see, e.g., FIG. 23 ), a first actuation shaft positioned on the outer portion of the curve follows a longer path length than a second actuation shaft positioned on the inner portion of the curve. 31, the proximal end portion of the first actuation shaft can move distally relative to the outer gear (and the other actuation shafts and the inner gear, assuming the actuation shafts are all the same length), and / or the proximal end portion of the second actuation shaft can move proximally relative to the outer gear (and the other actuation shafts and the inner gear). When shaft 206 is straight, the proximal end portions of the actuation shafts can move axially relative to the outer gear 714 and be axially aligned with each other.

[0111] To accommodate axial movement of the proximal end portion of the actuation shaft 210 and the internal gear 712, the external gear 714 can have an axial length L1 that is greater than the axial length L2 of the teeth 718 of the internal gear 712. This allows the teeth 718 of the internal gear 712 to remain engaged with the teeth 724 of the external gear 714 even when the components move axially relative to one another. The length L1 of the external gear 714 can be set to accommodate maximum changes in the length of the actuation shaft. In other words, the length L1 of the external gear 714 relative to the length L2 of the internal gear 712 is set so that the teeth 718 of the internal gear 712 remain engaged with the teeth 724 of the external gear 714 regardless of the axial position of the internal gear 712 (e.g., when the shaft 206 is torqued), which may vary based on the degree of curvature of the shaft 206 and / or the circumferential position of the actuation shaft 210 relative to the curvature. For example, in some embodiments, the ratio of lengths L1 and L2 can be between 1.5 and 10. In certain embodiments, the ratio of lengths L1 and L2 can be between 2 and 6. In some embodiments, the ratio of lengths L1 and L2 can be between 3 and 5. In still other embodiments, the ratio of lengths L1 and L2 can be between 4 and 4.5.

[0112] The delivery device 200 including the displacement control mechanism 700 can be used to implant a prosthetic valve. For example, as shown in FIG. 1 , the prosthetic valve 100 can be coupled to the delivery device 200 such that the actuation shaft 210 of the delivery device 200 is releasably (e.g., threadably) coupled to the respective rack members 120 of the prosthetic valve 100, and the support sleeve 208 of the delivery device 200 abuts the respective housing members 122 of the actuator 106. Similar to the manner described above in connection with FIGS. 16-19 , the prosthetic valve 100 and the delivery device 200 can be inserted into a patient's body, and the delivery device 200 can be used to deploy and implant the prosthetic valve 100 within the patient's body. Specifically, as the prosthetic valve 100 and the delivery device 200 are advanced through the patient's vasculature, the shaft 206 can bend through the patient's vasculature to the implantation location. As shaft 206 bends, displacement control mechanism 700 allows the proximal end portions of actuation shaft 210 (and inner gear 712) to move axially relative to each other and relative to outer gear 714 to accommodate different path lengths of actuation shaft 210. During such movement, inner gear 712 remains engaged with outer gear 714.

[0113] The prosthetic valve 100 can be expanded by actuating the actuation mechanism 220 of the handle 202, thereby moving the actuation member 704, the coupling member 702, the actuation shaft 210, and the rack member 120 axially proximally relative to the shaft 206, the support sleeve 208, and the housing member 122. As the actuation member 704 and the actuation shaft 210 move proximally, the inner gear 712 remains engaged with the outer gear 714.

[0114] If desired, the prosthetic valve 100 can be recompressed for repositioning and / or retrieval.

[0115] Once the prosthetic valve 100 is positioned and secured as desired within the patient, it may be released from the delivery device 200. This may be accomplished, for example, by actuating the gear assembly 706 of the displacement control mechanism 700, via actuating the release mechanism 222 of the delivery device 200. Actuation of the gear assembly 706 causes the outer gear 714 to rotate about its central axis relative to the handle 202, which in turn causes the inner gear 712 to rotate about its respective central axis. This in turn causes the actuation shaft 210 to rotate relative to the rack member 120 of the prosthetic valve 100, which retracts the threads 242 of the actuation shaft 210 from the threads of the rack member 120, thereby releasing the prosthetic valve 100 from the delivery device 200.

[0116] Thus, configuring the displacement control mechanism 700 in this manner allows a user to simultaneously move multiple actuation shafts (e.g., actuation shafts 210) axially via a single actuation member (e.g., actuation member 704). Furthermore, by allowing the proximal end portions of the actuation shafts 210 to move axially relative to one another, the displacement control mechanism 700 ensures that the distal end portions of all actuation shafts move a constant (or nearly constant) distance when the actuation member 704 is moved axially. This can be effective, for example, in ensuring that the prosthetic valve is uniformly radially expanded, even when the delivery device is in a curved configuration. The displacement control mechanism 700 can also simplify the actuation mechanism by having a single actuation member. Furthermore, the presently disclosed displacement control mechanism 700 allows the actuation shafts 210 to be rotated simultaneously via the gear assembly 706. This can allow, for example, the prosthetic valve to be quickly and easily released from the delivery device.

[0117] 32-34 illustrate a displacement control mechanism 800 according to another embodiment. Referring to FIG. 33, displacement control mechanism 800 (FIG. 32) includes a coupling member 802, an actuation member 804, and a gear assembly 806. In general, displacement control mechanism 800 is configured and operates similarly to displacement control mechanism 700. One difference between displacement control mechanism 800 and displacement control mechanism 700 is that gear assembly 806 of displacement control mechanism 800 is disposed at the distal end portion of delivery device 200 (see FIG. 32), rather than being disposed within handle 202 like gear assembly 706 of displacement control mechanism 700 (see FIG. 23). Note that shaft 206 is omitted from FIG. 34 for illustrative purposes.

[0118] The displacement control mechanism 800 can be used with various delivery devices. For example, in the illustrated embodiment, the displacement control mechanism 800 is shown with the delivery device 200. With reference to FIG. 32 , the coupling member 802 of the displacement control mechanism 800 is disposed within a distal end portion of the shaft 206 of the delivery device 200. For illustration purposes, the shaft 206 and the manifold 248 are shown as transparent. The coupling member 802 of the displacement control mechanism 800 is coupled to the actuation shaft 210 of the delivery device 200. The actuation member 804 of the displacement control mechanism 800 extends from the handle 202 of the delivery device 200, extends through the shaft 206, and is coupled to the coupling member 802 at the distal end portion. A proximal end portion of actuation member 804 is coupled to actuation mechanism 220 and release mechanism 222 of delivery device 200, which are coupled to and / or disposed within handle 202. Gear assembly 806 of displacement control mechanism 800 is disposed within a distal end portion of shaft 206. In other embodiments, gear assembly 806 may be disposed adjacent to the distal end portion of shaft 206 rather than within shaft 206.

[0119] In use, axial movement of the actuation member 804 relative to the shaft 206 causes the coupling member 802 and actuation shaft 210 to move axially (e.g., to expand the prosthetic valve), and rotational movement of the actuation member 804 relative to the shaft 206 causes the gear assembly 806 and actuation shaft 210 to rotate (e.g., to release the prosthetic valve from the delivery device 200). Further details regarding the displacement control mechanism 800 and its components are provided below.

[0120] Coupling member 802 may include a plurality of openings (not shown) extending axially therethrough (e.g., similar to openings 708 in coupling member 702). Referring to FIG. 33, the openings in coupling member 802 are configured to allow actuation shaft 210 to extend therethrough and rotate freely relative to coupling member 802.

[0121] The distal end portion of actuation shaft 210 is coupled to coupling member 802 such that it is unable to move axially relative to coupling member 802. This may be achieved by fixedly coupling peripheral gear 808 of gear assembly 806 to actuation shaft 210 either proximally (as shown) or distally of coupling member 802. Peripheral gear 808 is radially larger than the opening in coupling member 802. As such, peripheral gear 808 of gear assembly 806 limits relative axial movement between actuation shaft 210 and coupling member 802 in a first direction (e.g., the distal direction in the illustrated configuration). To limit relative axial movement in an opposite second direction (e.g., the proximal direction), a support member (not shown, but see stop member 710 in FIGS. 25-26 ) may be coupled to actuation shaft 210 on the side of coupling member 802 opposite peripheral gear 808. Thus, the actuation shaft 210 moves axially with the coupling member 802, the actuation member 804, the gear assembly 806, and the stop member.

[0122] In the illustrated embodiment, the actuation shafts 210 extend from a location distal to the support sleeve 208, through the support sleeve 208, through the coupling member 802, through the peripheral gear 808, through the shaft 206, and to the handle 202. In such an embodiment, the proximal end portions of the actuation shafts 210 can move axially relative to each other and relative to the handle 202. This allows the actuation shafts 210 to move axially relative to each other, thereby accommodating various path lengths for each actuation shaft (e.g., when the actuation shafts bend around a curve). Additionally, moving a single component (i.e., the actuation member 804) results in all of the actuation shafts moving simultaneously (via the coupling member 802) a constant (or at least substantially constant) distance, even when the proximal end portions of each actuation shaft are at different positions relative to each other. As a result, the displacement control mechanism 800 can be effective in ensuring uniform radial expansion of the prosthetic valve, even when the delivery device is placed in a curved configuration.

[0123] In other embodiments, the actuation shaft 210 can be relatively short. In such embodiments, a distal end portion of the actuation shaft 210 can extend beyond the distal end of the support sleeve 208, and a proximal end portion of the actuation shaft 210 can be coupled to the peripheral gear 808 of the displacement control mechanism 800. The relatively short length of the actuation shaft makes it less likely that the actuation shaft will be positioned along a curve in the patient's anatomy during expansion of the prosthetic valve. This reduces the need to allow the actuation shafts to move axially relative to each other while still achieving uniform expansion of the prosthetic valve.

[0124] Actuating member 804 is fixedly coupled to central gear 810 of gear assembly 806. Thus, actuating member 804 and central gear 810 move axially and rotate together. Central gear 810 is coupled to coupling member 802 such that it can rotate relative to coupling member 802 and is limited to moving axially relative to coupling member 802. For example, in some embodiments, central gear 810 may be mounted to coupling member 802 via a bearing.

[0125] The actuation shaft 210 and actuation member 804 may be coupled to the peripheral gear 808 and central gear 810, respectively, in a variety of ways, including, for example, fasteners 812, adhesives, welding, and / or other coupling means. In some embodiments, the actuation shaft 210, actuation member 804, and / or gears 808, 810 may include non-circular mating features (e.g., flats on the actuation shaft 210 and / or actuation member 804) to facilitate coupling and / or prevent relative rotational movement therebetween.

[0126] In the illustrated embodiment, gear assembly 806 is disposed proximally of coupling member 802. In other embodiments, gear assembly 806 may be disposed distally of coupling member 802. In such embodiments, coupling member 802 may include a central opening configured to allow actuation member 804 to extend therethrough and rotate therewithin. Central gear 810 may prevent actuation member 804 from moving proximally relative to coupling member 802, and a stop member may be disposed proximally of coupling member 802 to prevent actuation member 804 from moving distally relative to coupling member 802.

[0127] The peripheral gears 808 of the gear assembly 806 include teeth that mesh with the teeth of the central gear 810 of the gear assembly 806. Note that the peripheral gears 808 are restricted from rotating (i.e., orbiting) about the central axis of the central gear 810. Thus, rotation of the central gear 810 about its axis results in rotation of the peripheral gears 808 about their respective axes. Rotation of the central gear 810 about its axis in a first direction (e.g., clockwise) results in rotation of the peripheral gears 808 about their respective axes in a second direction (e.g., counterclockwise), and vice versa.

[0128] A prosthetic valve (e.g., prosthetic valve 100) may be coupled to delivery device 200 with displacement control mechanism 800 in a manner similar to that shown in FIG. 13 . Prosthetic valve 100 may be compressed and loaded into shaft 206 (see FIGS. 14-15 ). Prosthetic valve 100 may be inserted into a patient's vasculature, advanced to or near the implantation location, and deployed from shaft 206 (see FIGS. 16-17 ). Prosthetic valve 100 may be expanded by moving actuation member 804 of displacement control mechanism 800 proximally relative to shaft 206, thereby moving coupling member 802 and actuation shaft 210 relative to shaft 206 and moving rack member 120 of actuator 106 relative to housing member 122 of the actuator, thereby expanding frame 102 of prosthetic valve 100. The actuation member 804 can be moved proximally by actuating the actuation mechanism 220 and / or by manually moving the actuation member 804 proximally relative to the handle 202. Once the prosthetic valve 100 is expanded and secured at the implantation location (e.g., within the native valve annulus), the prosthetic valve 100 can be released from the delivery device 200 by rotating the actuation member 804 of the displacement control mechanism 800 about its axis relative to the shaft 206, which causes the central gear 810 to rotate about its axis, which in turn causes the peripheral gear 808 and actuation shaft 210 to rotate about their axes. This decouples the actuation shaft 210 from the rack member 120 of the actuator 106. The actuation member 804 can be rotated by actuating the release mechanism 222 and / or by manually rotating the actuation member 804 relative to the handle 202.

[0129] 35-40 illustrate a displacement control mechanism 900 and its components according to another embodiment. Similar to displacement control mechanisms 700 (and 800 and force control mechanisms 400, 506, 606), displacement control mechanism 900 allows the proximal end portions of the delivery device's actuation shafts to move axially relative to one another. Thus, displacement control mechanism 900 is effective in ensuring that the actuation shafts move the prosthetic valve's actuators a consistent distance, resulting in uniform expansion of the prosthetic valve. Displacement control mechanism 900 also allows the actuation shafts to be moved axially simultaneously, which can also be effective in ensuring uniform expansion of the prosthetic valve. Furthermore, displacement control mechanism 900 allows the actuation shafts to be rotated simultaneously, and thus released from the prosthetic valve's actuators.

[0130] 35 , the displacement control mechanism 900 can be coupled to and / or disposed within a handle of a delivery device, such as the handle 202 of the delivery device 200. The displacement control mechanism 900 includes a first gear assembly 902 and a second gear assembly 904. The first gear assembly 902 is movably coupled to the actuation shaft 210 and configured to convert rotational movement of the first gear assembly 902 into axial movement of the actuation shaft 210 (e.g., to expand the prosthetic valve). As such, the first gear assembly 902 can also be referred to as an “expansion gear assembly.” The second gear assembly 904 is fixedly coupled to the actuation shaft 210 and configured such that rotation of the second gear assembly 904 results in rotation of the actuation shaft 210 (e.g., to release the prosthetic valve from the delivery device). As such, the second gear assembly 904 can also be referred to as a “release gear assembly.”

[0131] 36 , the first gear assembly 902 of the displacement control mechanism 900 includes a first external gear 906 and a plurality of first internal gears 908 disposed within and engaged with the first external gear 906. As shown schematically in FIG. 35 , the first external gear 906 is coupled to the actuation mechanism 220 of the delivery device 200. For example, in some embodiments, the first external gear 906 may be coupled to an electric motor of the actuation mechanism 220 configured to rotate the first external gear 906 about its axis and relative to the handle 202. In other embodiments, the first external gear 906 may be coupled to or form an actuation knob of the actuation mechanism 220, which may be manually rotated relative to the handle 202.

[0132] 36 , the first external gear 906 has an axial length that is longer than the axial length of the first internal gear 908. This allows the first internal gear 908 to remain engaged with the first external gear 906 when the proximal end portion of the actuation shaft 210 is moved axially relative to the first external gear 906 (e.g., when the delivery device is curved and the actuation shafts follow different path lengths).

[0133] The first internal gears 908 may be coupled to their respective actuation shafts 210 such that relative rotational movement between the first internal gears 908 and the actuation shafts 210 results in relative axial movement between the first internal gears 908 and the actuation shafts 210. For example, as shown in FIG. 39 , the first gear assembly 902 includes inserts 910 fixedly coupled to each first internal gear 908. The inserts 910 include threaded bores 912 configured to engage corresponding threads on the proximal end portions of the actuation shafts 210.

[0134] The first internal gears 908 and the inserts 910 may be coupled together in a manner configured to limit relative rotational and / or axial movement therebetween. For example, the first internal gears 908 and the inserts 910 may be coupled together using adhesives, welding, mating features, and / or other coupling means. For example, as shown in FIGS. 37-39 , the first internal gears 908 and the inserts 910 include mating features configured to limit relative rotational movement therebetween. Specifically, each of the first internal gears 908 includes a non-circular (e.g., square) opening 914 that corresponds to the non-circular (e.g., square) outer surface of the insert 910. Furthermore, each of the first internal gears 908 includes a slot 915 configured to receive a corresponding tab 917 on the insert 910. These non-circular features and / or slots and tabs limit relative rotational and / or axial movement between the first internal gears 908 and their respective inserts 910. In other examples, various other non-circular shapes (e.g., polygonal, elliptical, etc.) and / or other types of mating features (e.g., "slot and key" connections) may be used to limit relative rotational and / or axial movement between the first internal gears 908 and their respective inserts 910.

[0135] 35-36 , rotating the first outer gear 906 about its central axis relative to the handle 202 results in the first inner gear 908 and the insert 910 rotating about their respective axes. The actuation shaft 210 does not rotate with the insert 910 because its rotational movement is restricted by the second gear assembly 904. Thus, the actuation shaft 210 moves axially relative to the insert 910 as the gears 906, 908, and insert 910 rotate due to the threaded connection between the actuation shaft 210 and the insert 910. When the distal end portion of the actuation shaft 210 is coupled to an actuator of a prosthetic valve, axial movement of the actuation shaft 210 results in expansion / contraction of the prosthetic valve.

[0136] The threads between the proximal end portion of the actuation shaft 210 and the threaded bore 912 of the insert 910 can be configured so that rotation of the gears 906, 908 in a desired rotational direction (e.g., clockwise / counterclockwise) results in a desired axial movement of the actuation shaft 210 (e.g., proximal / distal). For example, in some embodiments, the threads between the proximal end portion of the actuation shaft 210 and the threaded bore 912 of the insert 910 can be right-handed. In such embodiments, rotating the gears 906, 908 in a clockwise direction moves the actuation shaft proximally (e.g., to radially expand the prosthetic valve), and rotating the gears 906, 908 in a counterclockwise direction moves the actuation shaft distally (e.g., to radially contract the prosthetic valve). In other embodiments, the threads between the proximal end portion of the actuation shaft 210 and the threaded bore 912 of the insert 910 can be left-handed. In such an embodiment, rotating gears 906, 908 counterclockwise moves the actuation shaft proximally (e.g., to radially expand the prosthetic valve), and rotating gears 906, 908 clockwise moves the actuation shaft distally (e.g., to radially contract the prosthetic valve).

[0137] Instead of the insert 910, the first internal gear 908 can include a threaded bore configured to directly engage corresponding threads on the proximal end portion of the actuation shaft 210. In yet other embodiments, the proximal end portion of the actuation shaft 210 can have threaded members (e.g., sleeves) fixedly coupled (e.g., with adhesive, welding, fasteners, etc.) thereto. These threaded members can be configured to threadably mate with the respective threaded bores 912 of the insert 910 or the respective threaded bores of the first internal gear 908.

[0138] Varying thread pitches or thread counts ("TPI (threads per inch)") can be used on the proximal end portion of the actuation shaft 210 and the threads of the threaded bore 912 of the insert 910 to vary the axial distance traveled by the actuation shaft with each rotation of the internal gear 908. For example, a lower thread pitch / higher thread count results in less axial movement of the actuation shaft per rotation of the internal gear 908. In contrast, a higher thread pitch / lower thread count results in more axial movement of the actuation shaft per rotation of the internal gear 908.

[0139] Also, different diameters and / or gear ratios of the gears 906, 908 may be used to vary the axial distance traveled by the actuation shaft 210 with each rotation of the gears 906, 908.

[0140] 40 , second gear assembly 904 of displacement control mechanism 900 includes a second external gear 916 and a plurality of second internal gears 918 disposed within and engaged with second external gear 916. Generally, second gear assembly 904 of displacement control mechanism 900 may be configured and function similarly to gear assembly 706 of displacement control mechanism 700 in that it allows proximal end portions of actuation shafts 210 to move axially to accommodate the different path lengths traveled by the actuation shafts (e.g., due to curvatures in shafts 206) and is configured such that rotation of second external gear 916 simultaneously rotates the actuation shafts (e.g., to release the prosthetic valve from a delivery device).

[0141] 35 , the second external gear 916 may be coupled to and / or form a component of the release mechanism 222 of the delivery device 200. For example, in some embodiments, the second external gear 916 may be coupled to an electric motor of the release mechanism 222 configured to rotate the second external gear 916 relative to the handle 202. In other embodiments, the second external gear 916 may be coupled to or form a release knob of the release mechanism 222 that may be manually rotated relative to the handle 202.

[0142] 40 , the second external gear 916 can have an axial length that is longer than the axial length of the second internal gear 918. This allows the second internal gear 918 to remain engaged with the second external gear 916 when the proximal end portion of the actuation shaft 210 moves axially relative to the second external gear 916 (e.g., due to the different path lengths traveled by the actuation shafts).

[0143] The second internal gears 918 may be fixedly coupled to their respective actuation shafts 210 such that the second internal gears 918 and the actuation shafts 210 move together both axially and rotationally. The second internal gears 918 may be fixedly coupled to the actuation shafts 210 in a variety of ways, including fasteners (e.g., set screws and / or keyed connections), welding, adhesives, mating non-circular features, and / or other coupling means.

[0144] The second gear assembly 904 can be used to disengage / couple the actuation shaft 210 from / to the prosthetic valve. For example, rotating the gears 916, 918 in a first direction (e.g., clockwise) can rotate the actuation shaft 210 in the first direction, resulting in the threads 242 on the distal end portion of the actuation shaft 210 engaging the threads of the rack member of the prosthetic valve (e.g., if the threads on the distal end portion of the actuation shaft and the rack member are right-handed). Rotating the gears 916, 918 in a second direction (e.g., counterclockwise) can rotate the actuation shaft 210 in a second direction, resulting in the threads 242 on the distal end portion of the actuation shaft 210 disengaging from the threads of the rack member of the prosthetic valve (e.g., if the threads on the distal end portion of the actuation shaft and the rack member are right-handed).

[0145] During rotation of the first gear assembly 902 (e.g., when expanding / contracting the prosthetic valve), the second gear assembly 904 may be prevented from rotating with the first gear assembly 902. This may be achieved either actively (e.g., with a locking mechanism) or passively (e.g., by sufficient static friction in the second gear assembly 904). Thus, the second gear assembly 904 may be effective in preventing the actuation shaft 210 from rotating with the first internal gear 908 and the insert 910 of the first gear assembly 902, which may further facilitate axial movement of the actuation shaft 210 relative to the insert 910 due to the threaded connection between the actuation shaft 210 and the insert 910. Additionally, when the proximal end portions of the actuation shafts 210 move axially, either together due to rotation of the first gear assembly 902 (e.g., during valve expansion / contraction) or individually in response to the actuation shafts moving along paths of different lengths (e.g., when disposed in the aortic arch), the second inner gear 918 can move axially relative to the second outer gear 916.

[0146] In the illustrated embodiment, the first gear assembly 902 is disposed proximally of the second gear assembly 904. In other embodiments, the first gear assembly 902 may be disposed distally of the second gear assembly 904.

[0147] 41-42 show a sliding external gear 1000 that can be used, for example, in place of the first external gear 906 and the second external gear 916, with the displacement control mechanism 900. The sliding external gear 1000 can be moved (slid) axially between a first position and a second position. In the first position (FIG. 41), the sliding external gear 1000 engages the first internal gear 908 and disengages from the second internal gear 918. Rotating the sliding external gear 1000 (manually and / or via the actuation mechanism 220) while it is in the first position rotates the first internal gear 908 and moves the actuation shaft 210 axially relative to the first internal gear 908 (e.g., to expand or contract the prosthetic valve). Thus, the first position may also be referred to as the "expansion position" or "expansion mode." In the second position (FIG. 42), the sliding external gear 1000 engages the second internal gear 918 and disengages from the first internal gear 908. Rotating the sliding external gear 1000 when it is in the second position rotates the second internal gear 918 and thus the actuation shaft 210 (e.g., to release / couple the prosthetic valve). As such, the second position may also be referred to as the "release position" or "release mode."

[0148] The sliding external gear 1000 may provide several advantages. For example, the sliding external gear 1000 may reduce the number of components in the displacement control mechanism 900. The sliding external gear 1000 may also enhance safety by reducing the likelihood that a user will accidentally release the prosthetic valve from the delivery device. For example, in some embodiments, the displacement control mechanism 900 may include biasing members (e.g., springs), locking elements (e.g., switches and / or grooves), and / or other features configured to position and / or retain the sliding external gear 1000 in the extended position ( FIG. 41 ) by default. To release the prosthetic valve, the user must intentionally move the sliding external gear 1000 to the released position ( FIG. 42 ) by overcoming the bias, lock, etc., thereby reducing the likelihood of accidental release of the prosthetic valve.

[0149] 43-47 illustrate yet another embodiment of a displacement control mechanism 1100. As shown in FIG. 43, the displacement control mechanism 1100 can be used with, for example, a delivery device 200. The displacement control mechanism 1100 can be coupled to a proximal end portion of an actuation shaft 210 of the delivery device 200 and disposed within the handle 202 of the delivery device 200. In one mode of operation, the displacement control mechanism 1100 allows the proximal end portions of the actuation shafts 210 to move axially relative to the displacement control mechanism 1100 and relative to each other (e.g., when the actuation shafts are curved such that they follow different path lengths). In a second mode of operation, the displacement control mechanism 1100 can be used to simultaneously move the actuation shaft 210 axially relative to the shaft 206 and the support sleeve 208 (not shown) (e.g., to expand / contract a prosthetic valve). In a third mode of operation, the displacement control mechanism 1100 can be used to simultaneously rotate the actuation shaft 210 relative to the shaft 206 and the support sleeve 208 (eg, to release / couple the prosthetic valve).

[0150] 43 , the displacement control mechanism 1100 includes a first gear assembly 1102 and a second gear assembly 1104. The first gear assembly 1102 may be coupled to and / or may form a component of the actuation mechanism 220 of the delivery device 200. The second gear assembly 1104 may be coupled to and / or may form a component of the release mechanism 222 of the delivery device 200.

[0151] In the illustrated embodiment, the first gear assembly 1102 is disposed distally of the second gear assembly 1104. In other embodiments, the first gear assembly 1102 may be disposed proximally of the second gear assembly 1104.

[0152] The first gear assembly 1102 can be moved between an unlocked configuration and a locked configuration. When the first gear assembly 1102 is in the unlocked configuration, the proximal end portion of the actuation shaft 210 can move freely (axially and / or rotationally) relative to the first gear assembly 1102 and can move axially relative to the second gear assembly 1104 (e.g., to allow the actuation shafts to be adjusted to different path lengths and / or to unlock / couple the prosthetic valve to / from a delivery device). Also, when the first gear assembly 1102 is in the unlocked configuration, the second gear assembly 1104 can be used to simultaneously rotate the actuation shaft 210 relative to the shaft 206 and support sleeve 208 (e.g., to unlock / couple the prosthetic valve to / from a delivery device). When the first gear assembly 1102 is in the locked configuration, the actuation shafts 210 are fixed (axially and rotationally) relative to the first gear assembly 1102 and each other, and the first gear assembly 1102 can be used to simultaneously move the actuation shafts 210 axially relative to the second gear assembly 1104, the shaft 206, and the support sleeve 208 (e.g., to expand / contract the prosthetic valve). Further details regarding the first gear assembly 1102 and the second gear assembly 1104 and their operation are presented below.

[0153] 43-44, the first gear assembly 1102 includes a face gear 1106, a plurality of first spur gears 1108 (e.g., three), a carriage member 1110, a plurality of locking screws 1112 (FIG. 46), and a drive screw 1114. The face gear 1106 and the spur gears 1108 include teeth configured to mesh together, such that rotating the face gear 1106 about its axis causes the spur gears 1108 to rotate about their respective axes. The carriage member 1110 is coupled to the spur gears 1108 by the locking screws 1112 (see FIG. 46). The carriage member 1110 can be selectively coupled to the actuation shaft 210 via the locking screws 1112 (see FIGS. 46-47). The carriage member 1110 may also be movably coupled to the drive screw 1114, whereby rotating the drive screw 1114 about its axis relative to the carriage member 1110 results in axial movement of the carriage member 1110 (and axial movement of the actuation shaft 210 if coupled to the carriage member 1110).

[0154] The front gear 1106 of the first gear assembly 1102 may include teeth disposed on an axially facing surface configured to engage corresponding teeth on the spur gear 1108. In some embodiments, the front gear 1106 and the spur gear 1108 may be bevel-shaped (also referred to as "bevel gears"). In the illustrated embodiment, the teeth of the front gear 1106 are disposed on a distally facing surface of the front gear 1106. In other embodiments, the teeth of the front gear 1106 may be disposed on a proximally facing surface of the front gear 1106.

[0155] 44, the face gear 1106 has an annular shape with a central opening 1116, the carriage member 1110 is disposed within the central opening 1116, and the actuation shaft 210 may extend axially through the central opening 1116. In particular, the central opening 1116 allows the face gear 1106 to rotate about its axis relative to the carriage member 1110 and the actuation shaft 210. The face gear 1106 may be rotated manually and / or via a motor 1118 (FIG. 43).

[0156] 46 , each spur gear 1108 includes a central bore 1120 configured to receive a locking screw 1112. The spur gears 1108 also include an annular shoulder extending radially inward into the central bore 1120. The shoulder is configured to allow a shaft portion of the locking screw 1112 to extend beyond the shoulder into the carriage member 1110. The shoulder is also configured to engage a head portion of the locking screw 1112 such that the head portion cannot pass completely through the central bore 1120.

[0157] The locking screws 1112 are fixedly coupled to their respective spur gears 1108 such that the locking screws 1112 move (rotationally and axially) with their respective spur gears 1108. For example, in some embodiments, the central bores of the spur gears can have a non-circular cross-sectional shape (e.g., square, hexagonal, etc.) and the heads of the locking screws can have a corresponding non-circular cross-sectional shape. Additionally or alternatively, the locking screws can be fixedly coupled to their respective spur gears in a variety of other ways, including with fasteners (e.g., set screws), adhesives, welding, etc. In still other embodiments, the locking screws and spur gears can be integrally formed as a unitary structure. For example, the locking screws can be a unitary threaded shaft portion extending from a unitary spur gear portion. In such embodiments, the central bore 1120 can be omitted.

[0158] 43-44, the carriage member 1110 includes a main body 1122, an extension arm 1124, and a connecting element 1126. The main body 1122 is radially aligned with the central opening 1116 of the face gear 1106. The extension arm 1124 extends radially outward from the main body 1122, and the connecting element 1126 extends radially outward from the extension arm 1124.

[0159] As shown in FIGS. 46-47 , the main body 1122 of the carriage member 1110 includes a plurality of axial openings 1128 and a plurality of radial openings 1130. The axial openings 1128 are configured to receive the actuation shaft 210 and allow the actuation shaft 210 to move freely relative to the main body 1122. The radial openings 1130 extend radially outward from the axial openings 1128 to the outer surface of the main body 1122. The radial openings 1130 are surrounded by internal threads configured to engage corresponding external threads on the locking screw 1112. Rotating the locking screw 1112 relative to the carriage member 1110 moves the locking screw 1112 either into or out of the radial openings 1130 of the carriage member 1110 depending on the direction of rotation (e.g., clockwise / counterclockwise) and the thread configuration (e.g., right-hand / left-hand). This allows the locking screw 1112 to be engaged or disengaged from the actuation shaft 210 , thereby selectively limiting relative movement between the actuation shaft 210 and the carriage member 1110 .

[0160] 43-44, the coupling element 1126 of the carriage member 1110 includes an aperture having internal threads configured to engage corresponding external threads on the drive screw 1114. Thus, rotation of the drive screw 1114 about its axis relative to the coupling element 1126 results in axial translation of the carriage member 1110 along the drive screw 1114.

[0161] As mentioned above, and with reference again to FIGS. 46-47 , the first gear assembly 1102 can be moved between an unlocked configuration ( FIG. 46 ) and a locked configuration ( FIG. 47 ) by radially moving the locking screw 1112 relative to the radial opening 1130 in the carriage member 1110. The locking screw 1112 can be moved radially by rotating the spur gear 1108 about their respective axes relative to the carriage member 1110. Due to the threaded connection, such rotation moves the locking screw 1112 relative to the carriage member 1110. The locking screw 1112 can be rotated relative to the carriage member 1110 by rotating the face gear 1106 about its axis relative to the carriage member 1110, thereby rotating the spur gear 1108 and locking screw 1112 together about their respective axes and relative to the carriage member 1110.

[0162] Rotating the face gear 1106 about its axis in a first direction (e.g., counterclockwise) relative to the carriage member 1110 results in the spur gear 1108 and locking screw 1112 rotating about their respective axes in the first direction relative to the carriage member 1110. Rotating the locking screw 1112 counterclockwise relative to the carriage member 1110 (if it is a right-hand threaded configuration) backs off the locking screw 1112 from the radial opening 1130 in the carriage member 1110. The locking screw 1112 can be backed off relative to the carriage member 1110 so as not to block the axial opening 1128 in the carriage member 1110, as shown in FIG. 46 . This is the unlocked configuration of the first gear assembly 1102, allowing the actuation shaft 210 to move freely (axially and / or rotationally) relative to the carriage member 1110.

[0163] Rotating the face gear 1106 about its axis in a second direction (e.g., clockwise) relative to the carriage member 1110 results in the spur gear 1108 and locking screw 1112 rotating about their respective axes in the second direction relative to the carriage member 1110. Rotating the locking screw 1112 in a clockwise direction (if it is a right-hand threaded configuration) relative to the carriage member 1110 advances the locking screw 1112 into the radial opening 1130 of the carriage member 1110. As shown in FIG. 47 , the locking screw 1112 can be advanced relative to the carriage member 1110 so as to contact the actuation shaft 210 and urge the actuation shaft 210 radially inward against the inner wall of the carriage member 1110 that defines the axial opening 1128. This is the locking configuration of the gear assembly 1102, which limits relative axial movement between the actuation shaft 210 and the carriage member 1110 by frictional engagement between the lock screw 1112 and the inner walls of the actuation shaft 210 and the carriage member 1110.

[0164] The locking screw 1112 can be configured to prevent damage to the actuation shaft 210 when the locking screw 1112 contacts the actuation shaft 210. For example, in some embodiments, the locking screw 1112 can include an atraumatic tip configured to engage the actuation shaft 210 in a manner that does not result in damage to the actuation shaft 210.

[0165] 45 , the second gear assembly 1104 may include an external gear 1132 and a plurality of internal gears 1134 radially disposed within and engaging the external gear 1132. The second gear assembly 1104 may be configured and function similarly to the second gear assembly 904 of the displacement control mechanism 900 and / or the gear assembly 706 of the displacement control mechanism 700. The external gear 1132 of the second gear assembly 1104 has an axial length that is longer than the axial length of the internal gear 1134. This allows the internal gear 1134 to remain engaged with the external gear 1132 when the proximal end portion of the actuation shaft 210 is moved axially relative to the external gear 1132 (e.g., due to different path lengths of the actuation shafts and / or to expand / contract the prosthetic valve). The inner gears 1134 are fixedly coupled to their respective actuation shafts 210 such that the inner gears 1134 and actuation shafts 210 move together both axially and rotationally.

[0166] In this manner, the gear assembly 1104 can be used to disengage / couple the actuation shaft 210 from / to the prosthetic valve. For example, by rotating the gears 1132, 1134 in a first direction (e.g., clockwise), the actuation shaft 210 is rotated in the first direction, which results in the threads 242 on the distal end portion of the actuation shaft 210 engaging the threads on the rack member of the prosthetic valve (if the threads on the distal end portion of the actuation shaft and on the rack member are right-handed threads) (see FIGS. 11-12 ). By rotating the gears 1132, 1134 in a second direction (e.g., counterclockwise), the actuation shaft 210 is rotated in the second direction, which results in the threads 242 on the distal end portion of the actuation shaft 210 disengaging from the threads on the rack member of the prosthetic valve (if the threads on the distal end portion of the actuation shaft and on the rack member are right-handed threads).

[0167] The displacement control mechanism 1100 can be used with, for example, the delivery device 200 and the prosthetic valve 100. With the prosthetic valve 100 coupled to the distal end portion of the delivery device 200 and in a radially compressed configuration (see, for example, FIGS. 13-15 ), the prosthetic valve can be inserted into a patient's vasculature (e.g., the patient's left femoral artery). The first gear assembly 1102 of the displacement control mechanism 1100 can be positioned in an unlocked position while the prosthetic valve 100 and delivery device 200 are advanced through the patient's vasculature to an implantation location (e.g., the patient's native aortic valve). With the first gear assembly 1102 in the unlocked configuration, the proximal end portions of the actuation shaft 210 can move axially relative to each other, relative to the first gear assembly 1102, and relative to the outer gear 1132 of the second gear assembly 1104, thereby adjusting for varying actuation shaft travel path lengths due to curvatures in the shaft 206 of the delivery device 200 (e.g., when the shaft 206 is disposed in the aortic arch of a patient).

[0168] Once the prosthetic valve 100 is disposed at or near the implantation site, the first gear assembly 1102 of the displacement control mechanism 1100 can be moved from the unlocked configuration to the locked configuration by rotating the face gear 1106, the spur gear 1108, and the locking screw 1112 about their respective axes relative to the carriage member 1110, as described above. With the first gear assembly 1102 in the locked configuration, the drive screw 1114 can be rotated about its axis in a first direction relative to the extension arm 1124 of the carriage member 1110, thereby moving the carriage member 1110 and actuation shaft 210 proximally relative to the shaft 206 of the delivery device 200. This results in radial expansion of the prosthetic valve 100. The prosthetic valve 100 can be recompressed (e.g., for repositioning and / or retrieval) by rotating the drive screw 1114 in an opposite, second direction. The drive screw 1114 can be rotated in the first and second directions in a variety of ways, including by a motor or knob of the actuation mechanism 220 .

[0169] Once the prosthetic valve 100 is positioned and expanded within the patient as desired by the user, the prosthetic valve 100 can be locked in the radially expanded state and released from the delivery device 200. This can be achieved by moving the first gear assembly 1102 of the displacement control mechanism 1100 from a locked configuration to an unlocked configuration, allowing the actuation shaft 210 to move freely relative to the carriage member 1110. The outer gear 1132 of the second gear assembly 1104 is then rotated about its axis relative to the handle 202, causing the inner gear 1134 and actuation shaft 210 to rotate together about their respective axes. As a result, the threaded portion 242 located at the distal end portion of the actuation shaft 210 retracts from the prosthetic valve 100 actuator 106, thereby releasing the actuation shaft 210 from the prosthetic valve 100. The external gear 1132 of the second gear assembly 1104 can be rotated relative to the handle 202 in a variety of ways, including by a motor or knob of the release mechanism 222 and / or by directly rotating the external gear 1132. The delivery device 200 can then be withdrawn from the patient's vasculature.

[0170] 48-51 illustrate a multi-lumen shaft 1200 according to one embodiment. This multi-lumen shaft 1200 (also referred to as "shaft 1200") may be used with delivery device 200, for example, in place of shaft 206. Shaft 1200 includes multiple helical working lumens 1202a, 1202b, and 1202c (collectively and / or collectively referred to as "working lumens 1202") and a central lumen 1204 disposed radially inward from working lumens 1202. Working lumen 1202 may be configured to receive respective working shafts 210a, 210b, and 210c (collectively and / or collectively referred to as "working shafts 210"). Central lumen 1204 may be configured to receive nosecone shaft 214. Although not shown, shaft 1200 may include one or more other lumens, such as a recompression lumen.

[0171] Each working lumen 1202 extends in a helical path from the proximal end of the shaft 1200 to the distal end of the shaft 1200. Configuring the shaft 1200 with a helical working lumen 1202 can be effective, for example, to ensure that each working shaft follows a similar axial path length even when the shaft 1200 is in a curved configuration (e.g., when the shaft 1200 is disposed within a patient's aortic arch). This can be effective to reduce stretching in these curved working shafts 210 and / or to ensure that stretching in these curved working shafts 210 is at least substantially uniform. Each actuation shaft 210 extending through the shaft 1200 is disposed at a first circumferential position (e.g., a neutral position) on the shaft 1200 along its first length, at a second circumferential position (e.g., an outer position) on the shaft 1200 along its second length, at a third circumferential position (e.g., an inner position) on the shaft 1200 along its third length, and at various circumferential positions between the first, second, and third circumferential positions, so that the actuation shafts 210 travel a similar distance. Thus, the distance traveled by each actuation shaft 210 through the shaft 1200 is the same (or at least substantially similar) as the other actuation shafts 210 when the shaft 1200 is straight and when the shaft 1200 is curved. In this manner, the shaft 1200 can be effective, for example, in ensuring that a prosthetic valve is uniformly expanded.

[0172] As used herein, the terms "neutral position" and "neutral point" refer to the circumferential position of an actuation shaft when it is radially aligned with the plane of symmetry of the curved shaft through which it extends. For example, when shaft 1200 is curved to the left ( FIG. 48 ) or right, the neutral position of the actuation shaft is when it is at the 0 / 360 degree (12 o'clock) position (see, for example, the position of actuation shaft 210a in FIG. 49 ) and / or when it is at the 180 degree (6 o'clock) position. As used herein, the term "offset position / point" refers to any circumferential position of an actuation shaft when it is radially offset from the plane of symmetry of the curved shaft through which it extends. In other words, an offset position is any non-neutral position. As used herein, the term "outside position / point" refers to any circumferential position of an actuation shaft when it is radially offset outside the plane of symmetry of the curved shaft through which it extends. For example, when shaft 1200 is bent to the left (FIG. 48), the outer position of the actuation shaft is when the actuation shaft is located anywhere between 1 and 179 degrees (with the 90 degree position being the outermost position, see, e.g., the position of actuation shaft 210a in FIG. 50). As used herein, the term "inner position / location" refers to any circumferential position of the actuation shaft when the actuation shaft is radially offset inside the plane of symmetry of the curved shaft through which it extends. For example, when shaft 1200 is bent to the left (FIG. 48), the inner position of the actuation shaft is when the actuation shaft is located anywhere between 181 and 359 degrees (with the 270 degree position being the innermost position, see, e.g., the position of actuation shaft 210a in FIG. 51).

[0173] In some embodiments, all of the helical lumens 1202 can have the same pitch (i.e., the number of circumferential turns of each actuation lumen per unit axial length of the shaft), and various pitches can be used. Providing a relatively high pitch for the actuation lumens 1202 can help ensure that each actuation shaft 210 follows the same path length even when the shaft 1200 is bent at an acute angle. A high pitch can also reduce the force required to move the actuation shaft axially (e.g., when expanding a prosthetic valve). Therefore, the pitch of the actuation lumens 1202 of the shaft 1200 can be selected to accommodate the degree to which the shaft 1200 is bent during the implantation procedure while also allowing the actuation shaft to be moved axially to expand the prosthetic valve. For example, in some embodiments, the pitch of the actuation lumens can be less than 200 mm. In some embodiments, the pitch of the actuation lumens can be less than 140 mm. In some embodiments, the pitch of the actuation lumens can be between 140 mm and 70 mm. In certain embodiments, the pitch of the working lumens can be between 125 mm and 100 mm.

[0174] In the illustrated embodiment, the working lumens 1202 are uniformly distributed relative to one another around the circumference of the shaft 1200. In other words, there is approximately 120 degrees between adjacent working lumens 1202. In other embodiments, the working lumens 1202 may be non-uniformly distributed relative to one another.

[0175] In some embodiments, the delivery device can include a shaft and omit the force and / or displacement control mechanisms because the shafts 1200 are effective in ensuring that the shafts 1200 follow a similar distance when curved. This can be effective, for example, in ensuring that the prosthetic valve is uniformly expanded when the actuation shaft is moved axially.

[0176] In other embodiments, the delivery device 200 can include a shaft 1200, a force control mechanism, and / or a displacement control mechanism.

[0177] Although primarily shown and described in connection with prosthetic valve 100 and delivery device 200, it should be noted that the force control mechanisms, displacement control mechanisms, and multi-lumen shafts disclosed herein can be used with a variety of other prosthetic valves and / or delivery devices.

[0178] The disclosed delivery devices, components, and related methods for controlling actuation shaft force and / or displacement can be effective, for example, in ensuring that the force applied by the delivery device to the prosthetic heart valve is evenly distributed. This can reduce the likelihood that the delivery device and / or prosthetic heart valve will be damaged during the implantation procedure. The disclosed delivery devices and methods can also be effective in ensuring that the prosthetic heart valve is evenly expanded. The delivery devices disclosed herein are also relatively simple and / or easy to use. This can reduce the risk of failure and / or shorten the time required for implanting a prosthetic heart valve, for example.

[0179] Further examples of the techniques of the present disclosure In view of the above-described implementations of the subject matter of the present disclosure, the present application discloses the following additional embodiments: It should be noted that one feature of an embodiment alone or a combination of two or more features of that embodiment, optionally in combination with one or more features of one or more other embodiments, constitutes an additional embodiment that is also within the scope of the present disclosure of the present application. [Example]

[0180] A delivery device for implanting a prosthetic heart valve includes a handle, a first shaft, multiple actuation shafts, and a control mechanism. The first shaft has a first end portion, a second end portion, and one or more lumens extending from the first end portion to the second end portion. The first end portion is coupled to the handle. Each actuation shaft has a proximal end portion and a distal end portion, and the actuation shafts extend through the one or more lumens of the first shaft. A control mechanism is coupled to the actuation shafts and the handle. The control mechanism has a first operating mode and a second operating mode. In the first operating mode, the proximal end portions of the actuation shafts can be moved axially relative to each other and relative to the first shaft, and in the second operating mode, the actuation shafts can be moved axially simultaneously. [Example]

[0181] The delivery device of any embodiment of this section, particularly embodiment 1, wherein the control mechanism comprises a force control mechanism. [Example]

[0182] A delivery device of any embodiment of this chapter, particularly embodiment 2, wherein the force control mechanism comprises a pulley, and two proximal end portions of the actuation shaft are coupled together via the pulley, and when the two tensions in the actuation shaft are unequal, the two proximal end portions of the actuation shaft move axially relative to each other and the pulley rotates. [Example]

[0183] The delivery device of any embodiment of this section, particularly embodiment 2, wherein the plurality of actuation shafts comprises a first actuation shaft, a second actuation shaft, and a third actuation shaft; the force control mechanism comprises a carriage, a first pulley, a second pulley, and a third pulley; the carriage is movable relative to the handle; the first pulley and the second pulley are rotatably mounted relative to the carriage; the third pulley is fixed relative to the handle; proximal end portions of the first actuation shaft and the second actuation shaft are coupled together via the first pulley; and the third actuation shaft is fixed relative to the handle. A delivery device, wherein the shaft extends around the second pulley and the third pulley, and when the tension acting on the first actuating shaft is different from the tension acting on the second actuating shaft, the proximal end portions of the first actuating shaft and the second actuating shaft move axially relative to each other and the first pulley rotates, and when the tension acting on the third actuating shaft is different from the tension acting on the first actuating shaft and the second actuating shaft, the proximal end portion of the third actuating shaft moves relative to the first actuating shaft and the second actuating shaft and the second pulley rotates. [Example]

[0184] The delivery device of any embodiment of this section, particularly any one of embodiments 1 to 4, further comprising an actuation mechanism coupled to one of the actuation shafts and configured to axially move said actuation shafts simultaneously. [Example]

[0185] A delivery device of any embodiment of this chapter, particularly embodiment 5, wherein the actuation mechanism comprises a rotary knob, and rotation of the rotary knob results in simultaneous axial movement of the multiple actuation shafts. [Example]

[0186] A delivery device of any embodiment of this chapter, particularly embodiment 5, wherein the actuation mechanism comprises an electric motor having a rotating shaft, and rotation of the rotating shaft results in simultaneous axial movement of the multiple actuation shafts. [Example]

[0187] The delivery device of any embodiment of this chapter, particularly any one of embodiments 5 to 7, wherein the actuation mechanism comprises a spool configured to increase or decrease tension acting on the actuation shaft. [Example]

[0188] The delivery device of any embodiment of this section, particularly any one of embodiments 1 to 9, wherein the control mechanism comprises a displacement control mechanism. [Example]

[0189] A delivery device of any embodiment of this chapter, particularly embodiment 9, wherein the displacement control mechanism comprises a gear assembly having an outer gear and a plurality of inner gears, the inner gears being coupled to respective actuation shafts, and rotating the outer gears relative to the first shaft results in simultaneous rotational movement of the inner gears and actuation shafts relative to the first shaft. [Example]

[0190] A delivery device of any embodiment of this chapter, particularly embodiment 9, wherein the displacement control mechanism comprises a first gear assembly and a second gear assembly, and rotating the first gear assembly relative to the first shaft results in simultaneous axial movement of the multiple actuating shafts relative to the first shaft, and rotating the second gear assembly relative to the first shaft results in simultaneous rotational movement of the multiple actuating shafts relative to the first shaft. [Example]

[0191] The delivery device of any embodiment of this section, particularly embodiment 11, wherein the first gear assembly is coupled to the actuation mechanism and the second gear assembly is coupled to the release mechanism. [Example]

[0192] A delivery device of any embodiment of this chapter, particularly any of embodiments 11-12, wherein the displacement control mechanism comprises a sliding external gear configured to be moved between a first position and a second position, wherein in the first position the sliding external gear engages with a plurality of first internal gears of the first gear assembly, and in the second position the sliding external gear engages with a plurality of second internal gears of the second gear assembly. [Example]

[0193] A delivery device of any embodiment of this chapter, particularly embodiment 9, wherein the displacement control mechanism comprises a coupling member, an actuating member, and a gear assembly, the coupling member being coupled to a distal end portion of the actuating shaft, the actuating member extending through the first shaft, the first end portion of the actuating member being coupled to the coupling member, and the gear assembly being coupled to a proximal end portion of the actuating shaft, and axially moving the actuating member relative to the first shaft results in the coupling member and the actuating shaft being moved axially simultaneously relative to the first shaft and the gear assembly, and rotating the gear assembly relative to the first shaft results in the multiple actuating shafts being rotated simultaneously relative to the first shaft. [Example]

[0194] The delivery device of any embodiment of this section, particularly embodiment 14, wherein the actuation member is coupled to the actuation mechanism. [Example]

[0195] A delivery assembly comprising a delivery device of any embodiment of this section, in particular the delivery device of any one of embodiments 1 to 15, and a mechanically expandable prosthetic heart valve. [Example]

[0196] A delivery assembly of any embodiment of this chapter, particularly embodiment 16, wherein the mechanically expandable prosthetic heart valve comprises a frame having a plurality of struts and a plurality of actuators, the struts of the frame being pivotally coupled together, and the actuators being coupled to the struts of the frame and configured to transition the frame between a radially compressed configuration and a radially expanded configuration. [Example]

[0197] A delivery assembly of any embodiment of this chapter, particularly embodiment 17, wherein the actuation shaft of the delivery device is releasably coupled to the actuator of the prosthetic heart valve such that relative axial movement between the actuation shaft and the first shaft transitions the frame of the prosthetic heart valve between a radially compressed configuration and a radially expanded configuration. [Example]

[0198] A delivery device includes a handle, a first shaft, multiple actuation shafts, and a force control mechanism. The first shaft has a first end portion, a second end portion, and one or more lumens extending from the first end portion to the second end portion. The first end portion is coupled to the handle. Each actuation shaft has a proximal end portion and a distal end portion, and the actuation shaft extends through the one or more lumens of the first shaft. The force control mechanism is coupled to the actuation shafts and the handle. The force control mechanism is configured to allow the proximal end portions of the actuation shafts to move axially relative to each other when the first shaft is bent. [Example]

[0199] A delivery device of any embodiment of this chapter, particularly embodiment 19, wherein the force control mechanism comprises a pulley system interconnected with the actuation shaft. [Example]

[0200] A delivery device of any embodiment of this chapter, particularly embodiment 20, wherein the pulley system comprises one or more pulleys that are axially movable relative to the handle and one or more pulleys that are axially fixed relative to the handle. [Example]

[0201] A delivery device includes a handle, a first shaft, multiple actuation shafts, and a displacement control mechanism. The first shaft has a first end portion, a second end portion, and one or more lumens extending from the first end portion to the second end portion. The first end portion is coupled to the handle. Each actuation shaft has a proximal end portion and a distal end portion, and the actuation shaft extends through the one or more lumens of the first shaft. The displacement control mechanism is coupled to the actuation shafts and the handle. The displacement control mechanism is configured to allow the proximal end portions of the actuation shafts to move axially relative to each other when the first shaft is bent. [Example]

[0202] A delivery device of any embodiment of this chapter, particularly embodiment 22, wherein the displacement control mechanism comprises a gear assembly having an outer gear and a plurality of inner gears, the inner gears being fixedly coupled to respective actuation shafts, and rotating the outer gears relative to the first shaft results in simultaneous rotational movement of the inner gears and actuation shafts relative to the first shaft. [Example]

[0203] A delivery device of any embodiment of this chapter, particularly embodiment 23, wherein the outer gear has radially inwardly facing teeth having a first axial length, and the inner gear has radially outwardly facing teeth having a second axial length, the first axial length being greater than the second axial length such that the teeth of the inner gear remain engaged with the teeth of the outer gear when the actuation shafts are moved axially relative to one another. [Example]

[0204] The delivery device of any embodiment of this section, particularly embodiment 24, wherein the ratio of the first axial length to the second axial length is in the range of 1.5 to 10. [Example]

[0205] The delivery device of any embodiment of this section, particularly embodiment 24, wherein the ratio of the first axial length to the second axial length is in the range of 2 to 6. [Example]

[0206] The delivery device of any embodiment of this section, particularly embodiment 24, wherein the ratio of the first axial length to the second axial length is in the range of 3 to 5. [Example]

[0207] The delivery device of any embodiment of this section, particularly embodiment 24, wherein the ratio of the first axial length to the second axial length is in the range of 4 to 4.5. [Example]

[0208] A delivery device of any embodiment of this chapter, particularly embodiment 29, wherein the displacement control mechanism includes a gear assembly having an inner gear and a plurality of peripheral gears disposed radially outward from the inner gear and engaged with the inner gear, the gear assembly is spaced from the handle and disposed within or adjacent to the distal end portion of the first shaft, and rotating the peripheral gear relative to the first shaft rotates the peripheral gear relative to the first shaft, and the peripheral gears are fixedly coupled to their respective actuation shafts. [Example]

[0209] A delivery device of any embodiment of this chapter, particularly embodiment 29, wherein the displacement control mechanism further comprises a coupling member and an actuating member, the peripheral gear is rotatably coupled to the coupling member, a first end portion of the actuating member is coupled to the coupling member, and a second end portion of the actuating member is disposed within the handle, and axial movement of the actuating member relative to the first shaft results in simultaneous axial movement of the coupling member and the actuating shaft relative to the first shaft, and rotation of the actuating member relative to the first shaft results in simultaneous rotational movement of the internal gear, the peripheral gear, and the actuating shaft relative to the first shaft. [Example]

[0210] A delivery device of any embodiment of this section, particularly embodiment 30, wherein the actuation member is coupled to the actuation mechanism. [Example]

[0211] A delivery device comprising a handle, a first shaft, and multiple actuation shafts. The first shaft has a first end portion, a second end portion, and multiple helical lumens extending from the first end portion to the second end portion. The first end portion is coupled to the handle. Each actuation shaft has a proximal end portion and a distal end portion, and the actuation shaft extends through a respective helical lumen of the first shaft. [Example]

[0212] A delivery device includes a handle, a first shaft, multiple actuation shafts, a force control mechanism, and a displacement control mechanism. The first shaft has a first end portion, a second end portion, and one or more lumens extending from the first end portion to the second end portion. The first end portion is coupled to the handle. Each actuation shaft has a proximal end portion and a distal end portion, and the actuation shaft extends through the one or more lumens of the first shaft. The force control mechanism is coupled to the actuation shafts and to the handle. The force control mechanism is configured to allow the proximal end portions of the actuation shafts to move axially relative to each other when the first shaft is bent. The displacement control mechanism is coupled to the actuation shafts and to the handle. The displacement control mechanism is configured to allow the proximal end portions of the actuation shafts to move axially relative to each other when the first shaft is bent. [Example]

[0213] A delivery device includes a handle, a first shaft, multiple actuation shafts, and a force control mechanism. The first shaft has a first end portion, a second end portion, and multiple helical lumens extending from the first end portion to the second end portion. The first end portion is coupled to the handle. Each actuation shaft has a proximal end portion and a distal end portion, and the actuation shaft extends through each helical lumen of the first shaft. The force control mechanism is coupled to the actuation shafts and configured to evenly distribute force applied to the actuation shafts. [Example]

[0214] A delivery device includes a handle, a first shaft, multiple actuation shafts, and a displacement control mechanism. The first shaft has a first end portion, a second end portion, and multiple helical lumens extending from the first end portion to the second end portion. The first end portion is coupled to the handle. Each actuation shaft has a proximal end portion and a distal end portion, and the actuation shaft extends through each of the helical lumens of the first shaft. The displacement control mechanism is coupled to the actuation shafts and configured to allow the proximal end portions of the actuation shafts to move axially relative to each other when the first shaft is bent. [Example]

[0215] A delivery device includes a handle, a first shaft, multiple actuation shafts, a force control mechanism, and a displacement control mechanism. The first shaft has a first end portion, a second end portion, and multiple helical lumens extending from the first end portion to the second end portion. The first end portion is coupled to the handle. Each actuation shaft has a proximal end portion and a distal end portion, and the actuation shaft extends through each of the helical lumens of the first shaft. The force control mechanism is coupled to the actuation shafts and configured to uniformly distribute a force applied to the actuation shafts. The displacement control mechanism is coupled to the actuation shafts and configured to allow the proximal end portions of the actuation shafts to move axially relative to each other when the first shaft is bent. [Example]

[0216] A force control mechanism for a delivery device for implanting a prosthetic heart valve is provided. The force control mechanism includes a pulley system and a movable carriage. The pulley system is configured to interconnect multiple actuation shafts of the delivery device. The movable carriage is coupled to the pulley system and configured to be movably coupled to a handle of the delivery device. The pulley system and the movable carriage are configured to move axially and / or rotationally to balance forces applied to and / or transmitted by the actuation shafts of the delivery device. [Example]

[0217] A force control mechanism for a delivery device for implanting a prosthetic heart valve is provided. The force control mechanism includes a first pulley, a second pulley, a third pulley, and a carriage. The first pulley is configured to be coupled to a first actuation shaft and a second actuation shaft of the delivery device. The second pulley is configured to be coupled to a third actuation shaft of the delivery device. The third pulley is configured to be coupled to the third actuation shaft of the delivery device. The carriage is configured to be movably coupled to a handle of the delivery device. The first pulley and the second pulley are rotatably coupled to the carriage, and the carriage is axially movable relative to the third pulley. Proximal end portions of the first actuation shaft and the second actuation shaft move axially relative to each other, and the first pulley rotates when tension in the first actuation shaft and the second actuation shaft is unequal. When the tension in the third actuation shaft and the first actuation shaft or the second actuation shaft is unequal, the proximal end portion of the third actuation shaft moves axially relative to the first actuation shaft and the second actuation shaft, and the second pulley and the third pulley rotate. [Example]

[0218] A displacement control mechanism for a delivery device configured to implant a prosthetic heart valve is provided. The displacement control mechanism includes one or more gear assemblies configured to be coupled to actuation shafts of the delivery device. The gear assemblies are configured to allow proximal end portions of the actuation shafts to independently move axially relative to one another and simultaneously rotate the actuation shafts about their respective axes. [Example]

[0219] A displacement control mechanism of any embodiment of this chapter, particularly embodiment 39, wherein the one or more gear assemblies include a first gear assembly configured to be disposed within or near the distal end portion of the shaft of the delivery device. [Example]

[0220] A displacement control mechanism of any embodiment of this chapter, particularly embodiment 40, wherein the first gear assembly comprises an inner gear and a plurality of peripheral gears surrounding the inner gear. [Example]

[0221] A displacement control mechanism of any embodiment of this chapter, particularly embodiment 39, wherein the one or more gear assemblies include a first gear assembly configured to be disposed within a handle located at the proximal end portion of the delivery device. [Example]

[0222] A displacement control mechanism of any embodiment of this chapter, particularly embodiment 42, wherein the first gear assembly comprises a plurality of inner gears and an outer gear surrounding the inner gears. [Example]

[0223] A displacement control mechanism of any embodiment of this chapter, particularly any one of embodiments 42-43, wherein the one or more gear assemblies include a second gear assembly configured to be disposed within a handle located at the proximal end portion of the delivery device. [Example]

[0224] A displacement control mechanism of any embodiment of this chapter, particularly embodiment 44, wherein the second gear assembly comprises a plurality of inner gears and an outer gear surrounding the inner gears. [Example]

[0225] A displacement control mechanism of any embodiment of this chapter, particularly embodiment 42, wherein the first gear assembly comprises a face gear and a plurality of spur gears. [Example]

[0226] A shaft for a delivery device configured for implanting a prosthetic heart valve is provided, the shaft including a plurality of helical lumens extending from a first end portion of the shaft to a second end portion of the shaft, each helical lumen configured to receive an actuation shaft of the delivery device. [Example]

[0227] A shaft according to any embodiment of this chapter, particularly embodiment 47, wherein each spiral lumen is circumferentially spaced apart from an adjacent spiral lumen. [Example]

[0228] The shaft of any embodiment of this chapter, particularly any one of embodiments 47-48, wherein the shaft comprises 3 to 15 helical lumens. [Example]

[0229] The shaft of any embodiment of this chapter, particularly any one of embodiments 47-49, wherein the shaft comprises 3-6 helical lumens. [Example]

[0230] The shaft of any embodiment of this chapter, particularly any one of embodiments 47-50, wherein the shaft comprises exactly three helical lumens.

[0231] Unless otherwise stated, features described herein with respect to any example may be combined with other features described in any one or more of the other examples. For example, any one or more of the features of force control mechanism 400 may be combined with any one or more features of force control mechanism 606. As another example, any one or more features of displacement control mechanism 700 may be combined with any one or more features of displacement control mechanism 900.

[0232] In view of the numerous possible embodiments to which the principles of the present disclosure may be applied, it should be understood that these illustrated embodiments are examples only and should not be construed as limiting the scope of the claims. Moreover, the scope of claimed subject matter is defined by the appended claims and their equivalents. [Explanation of symbols]

[0233] 10 Delivery Assembly 100 Artificial Heart Valves 102 frames 104 Valve structure 106 Actuator 108 first end 110 second end 112 Strut 114 pins 116 Valve Leaflet 118 Commissure 120 Rack components 122 Housing member 124 Locking member 126 teeth 128 Brake 130 Female thread 170 Stopper member 200 Delivery device 202 Handle 204 First Shaft 206 Second Shaft 208 Support sleeve 210 operating shaft 210a First operating shaft 210b Second operating shaft 210c third actuation shaft 212 Recompression Shaft 214 Nose cone shaft 216 Nosecone 218 First mechanism, deployment mechanism 220 Second mechanism, actuation mechanism, expansion mechanism 222 Third mechanism, release mechanism, coupling mechanism 224 Fourth mechanism, nose cone mechanism 226 First Knob 228 Housing 230 Second Knob 232 Third Knob 234 Slider 236 First Lumen 238 recompression lumens 240 Guidewire lumen 242 Male thread 244 lumens 246 Recompression member 248 Distal Manifold 300 Heart 302 Aorta 304 Native aortic valve annulus 306 Left ventricle 400 Force Control Mechanism 402 First Dynamic Pulley 404 Second Dynamic Pulley 406 Static Pulley 408 Carriage 410 Base material 412 First connecting member 412a first end portion 412b second end portion 414 Second connecting member 414a first end portion 414b second end portion 416 Trucks 500 delivery device 502 Handle 504 Operating shaft 504a First operating shaft 504b Second operating shaft 504c Third operating shaft 504d Fourth working shaft 506 Force Control Mechanism 508 Operating mechanism 510 First Dynamic Pulley 512 Second Dynamic Pulley 514 Third Dynamic Pulley 516 Fourth Dynamic Pulley 518 Static Pulley 520 First Carriage 522 Second Carriage 524 First connecting member 526 Second connecting member 528 Third connecting member 530 Base material 532 Anchor 600 Delivery Device 602 Handle 604 Operating shaft 604a Operating shaft 604b Actuating shaft 604c Actuating shaft 604d Actuating shaft 604e Actuating shaft 606 Force Control Mechanism 608 Operating Mechanism 610 Dynamic Pulley 610a Dynamic Pulley 610b Dynamic Pulley 610c Dynamic Pulley 610d Dynamic Pulley 612 Static Pulley 612a static pulley 612b static pulley 614 Carriage 614a Carriage 614b Carriage 616 Connecting member 616a Connecting member 616b Connecting member 616c Connecting member 700 Displacement Control Mechanism 702 Connecting members 704 Actuating member 706 Gear Assembly 708 Opening 710 Stopper member 712 Internal Gear 714 Outer gear 716 Mounting part 718 teeth 720 Axial opening 721 Radial opening 722 Fixed Elements 724 teeth 800 Displacement Control Mechanism 802 Connecting member 804 Actuating member 806 Gear Assembly 808 Peripheral Gear 810 Central Gear 812 fasteners 900 Displacement Control Mechanism 902 First Gear Assembly 904 Second Gear Assembly 906 First outer gear 908 First internal gear 910 Insert 912 Threaded Bore 914 Opening 915 Slots 916 Second outer gear 917 tabs 918 Second internal gear 1000 Sliding external gear 1100 Displacement control mechanism 1102 First Gear Assembly 1104 Second Gear Assembly 1106 Front gear 1108 Spur gear, first spur gear 1110 Carriage member 1112 Lock screw 1114 Drive screw 1116 Central opening 1118 Motor 1120 central bore 1122 Main body 1124 Extension Arm 1126 Connected Elements 1128 Axial opening 1130 Radial opening 1132 Outer gear 1134 Internal gear 1200 Multi-lumen shaft, shaft 1202 working lumens 1202a Spiral working lumen 1202b Spiral working lumen 1202c Spiral Working Lumen 1204 central lumen

Claims

[Claim 1] 1. A delivery device for a prosthetic valve, comprising: The handle and a first shaft having a first end portion, a second end portion, and one or more lumens extending from the first end portion to the second end portion, the first end portion being coupled to the handle; a plurality of actuation shafts, each having a proximal end portion and a distal end portion, the actuation shafts extending through the one or more lumens of the first shaft; a control mechanism coupled to the actuation shaft and to the handle, the control mechanism having a first mode of operation and a second mode of operation, wherein in the first mode of operation, the proximal end portions of the actuation shafts are axially movable relative to each other and relative to the first shaft, and in the second mode of operation, the actuation shafts are axially movable simultaneously; A delivery device comprising:

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