Delivery Device and Method for Implanting an Artificial Heart Valve

Abstract

A delivery device for implanting a prosthetic valve includes a handle, a first shaft, multiple 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. 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 is configured such that in a first mode of operation, the actuation shafts can be moved axially relative to each other, and in a second mode of operation, the actuation shafts can be moved axially simultaneously. Additionally or alternatively, the first shaft can include multiple helical lumens configured to receive the actuation shafts.

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 Dec. 6, 2019. This provisional patent application is incorporated herein by reference.

[0002] This disclosure relates to implantable mechanically expandable artificial devices such as artificial heart valves, and delivery devices and methods for implanting artificial heart valves.

Background Art

[0003] The human heart can suffer from various heart valve diseases. These heart valve diseases can result in significant heart dysfunction and ultimately may require repairing the native valve or replacing the native valve with an artificial valve. There are numerous known repair devices (e.g., stents) and artificial valves, and numerous known methods for implanting these devices and artificial valves into humans. Percutaneous minimally invasive surgical approaches are utilized in various procedures to deliver artificial medical devices to body locations where surgical access is not readily possible or where access by other than surgical means is desirable. In one specific example, an artificial heart valve is attached in a crimped state on the distal end of a delivery device and can be advanced through a patient's vasculature (e.g., through the femoral artery and aorta) until the artificial heart valve reaches the implantation site within the heart. The artificial heart valve is then expanded to its functional size, for example, by inflating a balloon on which the artificial valve is mounted, activating a mechanical actuator that applies an expanding force to the artificial heart valve, or deploying the artificial heart valve from the sheath of the delivery device such that the artificial heart valve can self - expand to its functional size.

[0004] An artificial heart valve whose expansion depends on a mechanical actuator can be referred to as a "mechanically expandable" artificial heart valve. Mechanically expandable artificial heart valves may have one or more advantages compared to self-expanding and balloon-expandable artificial heart valves. For example, mechanically expandable artificial heart valves can be expanded to various diameters. Also, mechanically expandable artificial heart valves can be compressed after the initial expansion (e.g., for purposes such as repositioning and / or retrieval).

[0005] Despite having these advantages, mechanically expandable artificial heart valves may have multiple difficulties. For example, it may be difficult to control the forces applied to the artificial heart valve and / or the delivery device during the implantation procedure. These difficulties can be further complicated when the delivery device is disposed within a tortuous passage such as a patient's vasculature. Also, it can be difficult to release the mechanically expandable artificial heart valve from the delivery device. Furthermore, when there are multiple movable components to be controlled, with a typical delivery device, the user's operation may be difficult and / or time-consuming. Therefore, an improved delivery device and method for implanting a mechanically expandable artificial heart valve are needed.

Prior Art Documents

Patent Documents

[0006]

Patent Document 1

Patent Document 2

Patent Document 3

Patent Document 4

Patent Document 5

Patent Document 6

Patent Document 7

[0007] This specification describes an artificial heart valve, a delivery device, and a method for implanting an artificial heart valve. The delivery device and method of the present disclosure can be effective, for example, in ensuring that the force applied to the artificial valve by the delivery device is evenly distributed. Thereby, the possibility that the delivery device and / or the artificial heart valve are damaged during the implantation procedure can be reduced. Further, the delivery device and method of the present disclosure can be effective in ensuring that the artificial heart valve is evenly expanded. Also, the delivery device disclosed in this specification is relatively simple and / or easy to use. Thereby, for example, the risk of failure can be reduced and / or the time required for implanting the artificial heart valve can be shortened. [Means for Solving the Problems]

[0008] In a representative embodiment, a delivery device is provided for implanting an artificial heart valve. The delivery device includes a handle, a first shaft, a plurality of actuating 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 actuating shaft has a proximal end portion and a distal end portion, and these actuating shafts extend through one or more lumens of the first shaft. The control mechanism is coupled to the actuating shafts and to the handle. The control mechanism includes a first operating mode and a second operating mode. In the first operating mode, the proximal end portions of the actuating shafts are axially movable relative to each other and relative to the first shaft, and in the second operating mode, the actuating shafts are axially movable simultaneously.

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

[0010] In another representative embodiment, the delivery device includes a handle, a first shaft, a plurality of actuating 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 actuating shaft has a proximal end portion and a distal end portion, and the actuating shafts extend through one or more lumens of the first shaft. The force control mechanism is coupled to the actuating shafts and to the handle. The force control mechanism is configured such that when the first shaft is curved, the proximal end portions of the actuating shafts can move axially relative to each other.

[0011] In some embodiments, the force control mechanism includes a pulley system interconnected with the actuating shafts.

[0012] In another exemplary embodiment, the delivery device comprises a handle, a first shaft, a plurality of actuating 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 actuating shaft has a proximal end portion and a distal end portion, and the actuating shafts extend through one or more lumens of the first shaft. The displacement control mechanism is coupled to the actuating shafts and to the handle. The displacement control mechanism is configured such that when the first shaft is curved, the proximal end portions of the actuating shafts can move axially relative to each other.

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

[0014] In another exemplary embodiment, the delivery device comprises a handle, a first shaft, and a plurality of actuating shafts. The first shaft has a first end portion, a second end portion, and a plurality of helical lumens extending from the first end portion to the second end portion. The first end portion is coupled to the handle. Each actuating shaft has a proximal end portion and a distal end portion, and the actuating shafts extend through respective helical lumens of the first shaft.

[0015] In another representative embodiment, the delivery device includes a handle, a first shaft, a plurality of actuating 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 actuating shaft has a proximal end portion and a distal end portion, and the actuating shaft extends through one or more lumens of the first shaft. The force control mechanism is coupled to the actuating shaft and to the handle. The force control mechanism is configured such that when the first shaft is curved, the proximal end portions of the actuating shafts can move axially relative to each other. The displacement control mechanism is coupled to the actuating shaft and to the handle. The displacement control mechanism is configured such that when the first shaft is curved, the proximal end portions of the actuating shafts can move axially relative to each other.

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

[0017] In another representative embodiment, the delivery device comprises a handle, a first shaft, a plurality of actuating shafts, and a displacement control mechanism. The first shaft has a first end portion, a second end portion, and a plurality of helical lumens extending from the first end portion to the second end portion. The first end portion is coupled to the handle. Each actuating shaft has a proximal end portion and a distal end portion, and the actuating shafts extend through respective helical lumens of the first shaft. The displacement control mechanism is coupled to the actuating shafts and is configured such that when the first shaft is curved, the proximal end portions of the actuating shafts can move axially relative to each other.

[0018] In another representative embodiment, the delivery device comprises a handle, a first shaft, a plurality of actuating shafts, a force control mechanism, and a displacement limiting device. The first shaft has a first end portion, a second end portion, and a plurality of helical lumens extending from the first end portion to the second end portion. The first end portion is coupled to the handle. Each actuating shaft has a proximal end portion and a distal end portion, and the actuating shafts extend through respective helical lumens of the first shaft. The force control mechanism is coupled to the actuating shafts and is configured to evenly distribute the force applied to the actuating shafts. The displacement control mechanism is coupled to the actuating shafts and is configured such that when the first shaft is curved, the proximal end portions of the actuating shafts can move axially relative to each other.

[0019] In another representative embodiment, a force control mechanism for a delivery device for implanting an artificial heart valve is provided. The force control mechanism comprises a pulley system and a movable carriage. The pulley system is configured to interconnect with a plurality of actuating shafts of the delivery device. The movable carriage is coupled to the pulley system and is configured to be movably coupled to the handle of the delivery device. The pulley system and the movable carriage are configured to balance the force applied to the actuating shafts of the delivery device and / or the force transmitted by the actuating shafts of the delivery device by moving axially and / or rotationally.

[0020] In another representative embodiment, a force control mechanism for a delivery device for implanting an artificial heart valve is provided. This 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 operating shaft and a second operating shaft of the delivery device. The second pulley is configured to be coupled to a third operating shaft of the delivery device. The third pulley is configured to be coupled to the third operating 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. The proximal end portions of the first operating shaft and the second operating shaft move axially relative to each other, and the first pulley rotates when the tensions in the first operating shaft and the second operating shaft are not equal. When the tension in the third operating shaft is not equal to the tension in the first operating shaft or the second operating shaft, the proximal end portion of the third operating shaft moves axially relative to the first operating shaft and the second operating shaft, and the second pulley and the third pulley rotate.

[0021] In another representative embodiment, a displacement control mechanism for a delivery device configured to implant an artificial heart valve is provided. This displacement control mechanism includes one or more gear assemblies. These gear assemblies are configured to be coupled to an operating shaft of the delivery device. These gear assemblies are configured such that the proximal end portions of the operating shaft can move axially independently of each other, and are configured to rotate the operating shaft simultaneously about their respective axes.

[0022] In another representative embodiment, a shaft for a delivery device configured to implant an artificial heart valve is provided. This shaft includes a plurality of helical lumens extending from a first end portion of the shaft to a second end portion of the shaft, and each helical lumen is configured to receive an operating 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, and these concepts will be further described in the detailed description that follows. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. The foregoing and other objects, features, and advantages of the present disclosure will become more apparent from the following detailed description, the claims, and the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0024]

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[0025] General Matters In the embodiments for carrying out the present invention, some aspects, advantages, and novel features of the embodiments of the present disclosure are described. These disclosed methods, apparatuses, and systems should not be construed as limiting in any way. Rather, the present disclosure is directed to all novel and non-obvious features and aspects of the various disclosed embodiments, both individually and in various combinations and sub-combinations with each other. These methods, apparatuses, and systems are not limited to any particular aspect or feature or combination thereof, and the embodiments of the present disclosure do not require the presence of any one or more particular advantages or the solution of any problems.

[0026] Although some of the operations in the embodiments of the present disclosure are described in a specific sequential order for convenience of presentation, it should be understood that this description method includes a change in order unless the specific order is required by the specific language shown hereinafter. For example, a series of operations described sequentially may, in some cases, be changed in order or performed simultaneously. Further, for reasons of simplification, the accompanying drawings may not show various ways in which the method of the present disclosure can be utilized in combination with other methods. Further, sometimes, this description uses terms such as "realize" or "achieve" to describe the method of the present disclosure. These terms are highly abstract representations of the actual operations to be performed. The actual operations corresponding to these terms may vary depending on the specific implementation form and are easily recognizable to those skilled in the art.

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

[0028] As used herein, the term "proximal" refers to the position, direction, or part of the device that is closer to the user and farther from the implantation site. As used herein, the term "distal" refers to the position, direction, or part of the device that is farther from the user and closer to the implantation site. Thus, for example, proximal movement of the device is movement of the device away from the implantation site and toward the user (e.g., outside the patient's body), and distal movement of the device is movement of the device away from the user and toward the implantation site (e.g., into the patient's body). The terms "longitudinal" and "axial" refer to an axis extending in the proximal and distal directions unless otherwise clearly defined.

[0029] Examples of the technology of the present disclosure In this specification, an artificial heart valve, a delivery device, and a method for implanting an artificial heart valve are described. The delivery device and method of the present disclosure can be effective, for example, in ensuring that the force applied to the artificial valve by the delivery device is evenly distributed. Thereby, the possibility that the delivery device and / or the artificial heart valve are damaged during the implantation procedure can be reduced. Further, the delivery device and method of the present disclosure can be effective in ensuring that the artificial heart valve is evenly expanded. Also, the delivery device disclosed herein is relatively simple and / or easy to use. Thereby, for example, the risk of failure can be reduced and / or the time required for implanting the artificial heart valve can be shortened.

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

[0031] Figure 2 shows the prosthetic valve 100. As shown, the prosthetic valve 100 includes three main components, namely 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 "support structure") can be configured to support the valve structure 104 and to secure the prosthetic valve 100 within the native heart valve. The valve structure 104 is coupled to the frame 102 and / or the actuator 106. The valve structure 104 is configured to allow blood flow to pass through the prosthetic valve 100 in one direction (i.e., in the antegrade direction) and to restrict blood flow from passing through the prosthetic valve 100 in the opposite direction (i.e., in the retrograde direction). The actuator 106 is coupled to the frame 102 and is configured to regulate the expansion of the frame 102 into a plurality of configurations, including one or more functional configurations or expanded configurations (e.g., FIGS. 2-3), one or more delivery configurations or compressed configurations (e.g., FIG. 4), and / or one or more intermediate configurations intermediate the functional configuration and the delivery configuration. Note that the valve structure 104 of the prosthetic valve 100 is not shown in FIGS. 1 and 3-4 for purposes of illustration.

[0032] Referring to FIG. 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, it is possible for the first end 108 of the frame 102 to be the outflow end and the second end 110 of the frame 102 to be the inflow end.

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

[0034] Referring further to FIG. 3, the frame 102 comprises a plurality of interconnected struts 112 configured in a lattice type pattern. In FIG. 3, the frame 102 of the prosthetic valve 100 is in a radially expanded configuration, and as a result of this configuration, the struts 112 of the frame 102 extend in a diagonal direction with respect to the longitudinal axis of the prosthetic valve 100. In other configurations, the struts 112 of the frame 102 can be offset by an amount different from the amount 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 the transition between these expanded and compressed configurations, the struts 112 of the frame 102 are pivotally coupled to each other at one or more pivot joints along the length of each strut. For example, each strut 112 can be formed to have apertures at both ends and along the length of the strut. The frame 102 comprises hinges at positions where the struts 112 overlap and are pivotally coupled together by fasteners such as rivets or pins 114 that extend through the apertures of the struts 112. These hinges enable the struts 112 to pivot relative to each other when the frame 102 is transitioned between the radially expanded configuration and the radially compressed configuration, for example, during the assembly, preparation, and / or implantation of the prosthetic valve 100.

[0036] In some embodiments, the frame 102 can be made by forming each component (e.g., struts 112 and pins 114 of the frame 102) and then mechanically assembling and joining these components together. In other embodiments, the struts are not joined to each other using each hinge, but are rotatable or bendable relative to each other in other ways to allow for radial expansion and radial contraction of the frame. For example, the frame can be formed from a single piece of material (e.g., a metal tube) (e.g., by laser cutting, electroforming, or physical vapor deposition, etc.). Further details regarding the fabrication of these frames and prosthetic valves are described in Patent Document 1, Patent Document 2, Patent Document 3, and International Application Patent Documents 4 and 5, and these patent documents are incorporated herein by reference. Further examples of expandable prosthetic valves that can be used with the delivery device disclosed herein are described in Patent Document 6 and Patent Document 7, and these U.S. patents are incorporated herein by reference.

[0037] Referring again to FIG. 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 to pass 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 consist of, for example, a valve tip assembly having one or more valve tips 116 (e.g., three valve tips in the illustrated embodiment).

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

[0039] Referring to FIG. 2, the valve tips 116 can be configured to form intersections 118 (e.g., pairs of adjacent valve tips), and these intersections 118 can be attached to, for example, each actuator 106. Further details regarding the artificial heart valve, including the manner in which the valve structure 104 can be coupled to the frame 102 of the artificial valve 100, can be found in Patent Documents 8, 9, 10, 11, 12, and 13. These patent documents are incorporated herein by reference.

[0040] The valve structure 104 can be coupled to the actuator 106. For example, the intersections 118 of the valve structure 104 can be coupled to the housing member 122 of the actuator 106. Further details regarding coupling the valve structure to the actuator can be found, for example, in International Application Patent Document 5.

[0041] As shown in FIG. 3, the actuator 106 of the artificial valve 100 is attached to the inner surface of the frame 102 and is circumferentially spaced along this inner surface. The actuator 106 is configured to, in particular, radially expand and / or radially compress the frame 102. Thus, the actuator 106 can also be referred to as an "expansion mechanism." The actuator 106 is also configured to lock the frame 102 in a desired expanded configuration. Thus, the actuator 106 can also be referred to as a "locker" or a "locking mechanism." As will be further described hereinafter, each actuator 106 can be configured to form a releasable connection with one or more respective operating shafts of the delivery device.

[0042] Next, referring to FIGS. 5-6, each actuator 106 includes a rack member 120 (which may also be referred to as an "actuating member"), a housing member 122 (which may also be referred to as a "supporting member"), and a locking member 124. The rack member 120 is coupled to the frame 102 of the artificial valve 100 at a first axial position (e.g., near the inflow end 108 of the frame 102), and the housing member 122 may be coupled to this frame at a second axial position (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 of these housing members 122. Thus, the axial relative 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 pivot relative to each other about the pins 114, thereby resulting in a 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 causes the frame 102 to expand radially (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 causes the frame 102 to be compressed radially (e.g., FIG. 4).

[0043] As shown in FIG. 6, one or more of the rack members 120 includes segments having a plurality of teeth 126. Each locking member 124 is coupled to each housing member 122 and includes a detent 128 biased to engage the teeth 126 of the rack member 120. By doing so, the rack member 120 and the locking member 124 form a ratchet-type mechanism, and by this ratchet-type mechanism, the rack member 120 is enabled to move proximally relative to the housing member 122 (thereby enabling expansion of the artificial valve 100), and the rack member 120 is restricted from moving distally relative to the housing member 122 (thereby restricting compression of the artificial valve 100).

[0044] In the illustrated embodiment, the lock member 124 is integrally formed with the housing member 122 as a single structure. In other embodiments, the lock member 124 and the housing member 122 can be formed as separate components that are coupled together (e.g., using fasteners, adhesives, welding, and / or other coupling means).

[0045] In the illustrated embodiment, the prosthetic valve 100 includes three actuators 106. In other embodiments, it is possible to use more or fewer actuators. For example, in one embodiment, the prosthetic valve can have one actuator. As another example, the prosthetic valve can have two actuators. In yet other examples, the prosthetic valve can have 4 to 15 actuators.

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

[0047] Figures 7-10 show the delivery device 200 and its components, which may also be referred to as the "valve catheter" or the "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 actuating shafts 210 (e.g., three in the illustrated embodiment), an optional recompression shaft 212, a nose cone shaft 214, and a nose cone 216. The handle 202 is configured to manipulate the shafts and sleeves relative to each other. The artificial heart valve 100 is releasably coupled to the distal end portion of the delivery device 200 (see, e.g., FIGS. 11-13), and the delivery device 200 can be used to position the artificial valve 100 and / or expand, compress, and lock the artificial valve 100 into a desired radially expanded configuration.

[0048] In the illustrated embodiment, the delivery device 200 includes three pairs of support sleeves 208 and actuating shafts 210 (i.e., one pair of support sleeves 208 and actuating shafts 210 for each actuator 106 of the artificial 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., 4-15) pairs of support sleeves 208 and actuating shafts 210, depending on the number of actuators provided by the artificial valve.

[0049] The handle 202 of the delivery device 200 includes one or more mechanisms configured to move the shafts and sleeves relative to each other. 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 each other. As will be further described hereinafter, the first mechanism 218 of the handle 202 can be used to deploy the artificial valve 100 from the delivery capsule of the first shaft 204 (see FIG. 7). Therefore, the first mechanism 218 can be referred to as a "deployment mechanism".

[0051] In the illustrated embodiment, the first mechanism 218 includes a first knob 226 configured to operate the first mechanism 218. Although not shown, in other embodiments, the first mechanism 218 can include various other types of actuators configured to operate the first mechanism 218, such as buttons, switches, etc. Further, the first mechanism 218 can include one or more other non-illustrated components (such as an electric motor, a rotary shaft, a drive screw, a gear assembly, etc.) configured to facilitate and / or limit the axial relative movement between the first shaft 204 and the second shaft 206. For example, the first mechanism 218 can be configured such that by rotating the first knob 226 (and / or the electric motor) relative to the housing 228 of the handle 202, an axial relative movement between the first shaft 204 and the second shaft 206 is consequently obtained.

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

[0053] In the illustrated embodiment, the second mechanism 220 includes a second knob 230 configured to operate 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 the axial relative movement of the actuating shaft 210 relative 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 housing 228 of the handle results in axial relative movement between the actuating shaft 210 and the support sleeve 208.

[0054] Also, a third mechanism 222 of the handle 202 is coupled to the actuating shaft 210 and is configured to rotate the actuating shaft 210 relative to the support sleeve 208. By doing so, the third mechanism 222 can be used to simultaneously couple and decouple the actuating shaft 210 to and from the artificial valve 100, as will be further described hereinafter. Accordingly, the third mechanism 222 can be referred to as a "decoupling mechanism" or a "coupling mechanism".

[0055] In the illustrated embodiment, the third mechanism 222 includes a third knob 232 configured to operate the third mechanism 222. In other embodiments, the third mechanism 222 can include various other types of actuators. Also, the third mechanism 222 can include one or more other components (such as a gear assembly and / or an electric motor) configured to facilitate and / or limit the rotational relative movement between the actuating 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 actuating shaft 210 relative to the support sleeve 208.

[0056] The fourth mechanism 224 of the handle 202 is coupled to the nose cone shaft 214 and is configured to axially move the nose cone shaft 214 and the nose cone 216 relative to the first shaft 204 and the second shaft 206. Therefore, the fourth mechanism 224 may be referred to as a "nose cone mechanism".

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

[0058] Next, referring to FIGS. 7-8, the proximal end portion of the first shaft 204 is coupled to the handle 202 and extends distally from this handle 202. The first shaft 204 includes a lumen for receiving the 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). Thus, the first shaft 204 can 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 this first shaft 204. The second shaft 206 includes a plurality of lumens extending axially therethrough and can thus 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 from each other. The first lumens 236 can be configured to receive the respective actuation shafts 210 and / or support sleeves 208. In the illustrated embodiment, the first lumens 236 are evenly spaced from each other (i.e., spaced approximately 120 degrees apart). In other embodiments, the first lumens 236 can be unevenly spaced from each other.

[0060] In some embodiments, the second shaft 206 can further include one or more additional lumens. For example, as shown in FIG. 9, the second shaft 206 includes a recompression lumen 238 and a guide wire lumen 240. The guide wire lumen 240 can be disposed radially centrally within the second shaft 206. The recompression lumen 238 can be disposed radially outward of the guide wire lumen 240. In some embodiments, the recompression lumen 238 can be radially aligned with the first lumens 236 and / or circumferentially spaced from the first lumens 236.

[0061] The support sleeve 208 may extend distally from each first lumen 236 of the second shaft 206 and be configured to contact the actuator 106 of the artificial valve 100 (see FIG. 12). The support sleeve 208 may have a relatively high rigidity compared to the actuating shaft 210. Thus, the support sleeve 208 can be used to apply a distal force to the housing member 122 of the actuator 106, which can counteract the proximal force applied to the rack member 120 of the actuator 106 by the actuating shaft 210 of the delivery device 200, thereby enabling expansion of the artificial valve 100 caused by axial relative movement between the rack member 120 and the housing member 122 of the actuator 106.

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

[0063] The actuating shaft 210 may pass through the respective first lumens 236 of the handle 202 and the second shaft 206, and extend distally through the lumen of the respective support sleeve 208. The distal end portion of the actuating shaft 210 may comprise mating features configured to releasably couple the actuating shaft to the actuator 106 of the prosthetic valve 100. For example, as shown in FIGS. 10-12, the distal end portion of the actuating shaft 210 comprises a male threaded portion 242 configured to mate with a corresponding female threaded portion 130 of the rack member 120 of the actuator 106.

[0064] In some embodiments, the actuating shaft 210 can be a relatively flexible member. For example, the actuating shaft can be a wire, cable, cord, suture, or the like. In other embodiments, the actuating shaft can be a relatively rigid member such as a rod. In other embodiments, the actuating shaft 210 can comprise 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 FIG. 8, the recompression shaft 212 extends through the recompression lumen 238 of the handle 202 and the second shaft 206. As shown in FIG. 9, the recompression shaft 212 comprises a lumen 244 through which a recompression member 246 (e.g., a wire, cable, suture, etc.) extends. As shown in FIG. 13, the recompression member 246 can extend circumferentially around the prosthetic valve 100 in an annular fashion. Thus, the recompression member 246 can be used to recompress the prosthetic valve 100 by applying tension to and thereby tightening the recompression member 246 around the prosthetic valve 100.

[0066] The artificial valve 100 can be coupled to the distal end portion of the delivery device 200 to form a delivery assembly (see FIGS. 11-13). Further, the delivery device 200 can be used to implant the artificial valve 100 into a patient's body (see FIGS. 13-19). The artificial valve 100 can 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, in a state where the artificial valve 100 is in a radially expanded configuration, the artificial valve 100 can be positioned to cover the proximal portion of the nose cone 216 and the nose cone shaft 214, and optionally within the loop of the recompression member 246. The actuator 106 of the artificial valve 100 can be positioned adjacent to the distal end of the actuating shaft 210 as shown in FIG. 11. Then, as shown in FIG. 12, the actuating shaft 210 can be inserted into the housing member 122 of the actuator 106 and threaded to the rack member 120 of the actuator 106.

[0067] In a state where the artificial valve 100 is releasably coupled to the delivery device 200 (see FIG. 13), the artificial valve 100 can be radially compressed by actuating the actuator 106, applying tension to the recompression member 246, and / or inserting the artificial valve 100 and the delivery device 200 into a crimping device. Further details regarding an example of a crimping device for a mechanically expandable artificial valve can be found in International Application Patent Document 14, which is incorporated herein by reference. FIG. 14 shows the artificial 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 artificial valve 100, and the artificial valve 100 is disposed within the lumen of the first shaft 204, and the distal end of the first shaft 204 can abut the nose cone 216. This can be achieved, for example, by actuating the first mechanism 218 of the handle 202.

[0068] Next, the distal end portion of the delivery assembly 10 is inserted into the patient's vasculature, and the prosthetic valve 100 can be advanced to the implantation position using the delivery device 200. For example, FIGS. 16-19 illustrate an exemplary implantation technique for implanting the prosthetic valve 100 into the patient's heart 300 using a transfemoral delivery technique. In other embodiments, various other delivery techniques such as transventricular, transapical, transseptal, etc. can be utilized.

[0069] Referring to FIG. 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 nose cone 216 extends into the left ventricle 306 of the patient's heart 300 through the patient's native aortic valve annulus 304. Referring to FIG. 17, the prosthetic valve 100 can 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 in a proximal direction relative to the second shaft 206 of the delivery device 200 (and / or moving the second shaft 206 in a distal direction relative to the first shaft 204). The first shaft 204 can be further moved in the proximal direction such that the support sleeve 208 is exposed from the distal end portion of the first shaft 204 (see, e.g., FIG. 14).

[0070] As shown in FIG. 18, the prosthetic valve 100 can then be radially expanded. This can be achieved, for example, by actuating the second mechanism 220 of the handle 202 such that the actuating shaft 210 and the rack member 120 of the actuator 106 (coupled to the actuating shaft 210) move in a proximal direction relative to the support sleeve 208 and the housing member 122 of the actuator 106 (abutting the distal end portion of the support sleeve 208). Once the prosthetic valve 100 is positioned and fixed within the native aortic valve annulus 304 as desired, the lock member 124 can engage the rack member 120 to hold the prosthetic valve 100 in the expanded state.

[0071] When 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. Instead of or in addition to using the second mechanism 220, the prosthetic valve 100 can be recompressed using a recompression member 246 and repositioned and / or retrieved. In some examples, the recompression member 246 can radially compress the prosthetic valve to a diameter smaller than the diameter made possible by use of the actuator 106 alone. For purposes of illustration, note that the recompression shaft 212 and the recompression member 246 are not shown in FIGS. 17-18, and the nose cone shaft 214 and the nose cone 216 are not shown in FIGS. 18-19.

[0072] Once deployed and secured, the prosthetic valve 100 can then be released from the delivery device 200 as shown in FIG. 19. This can be accomplished by actuating a third mechanism 222 of the handle 202. Thereby, the actuating shaft 210 of the delivery device 200 is rotated relative to the rack member 120 of the prosthetic valve 100, whereby the threaded portion 242 of the actuating shaft 210 is disengaged from the threaded portion 130 of the rack member 120. The actuating shaft 210, the support sleeve 208, and the second shaft 206 can then be retracted into the first shaft 204 and the delivery device 200 can be removed from the patient's body.

[0073] During the implantation procedure, the delivery device is advanced through the patient's vasculature. The patient's vasculature may include various curvatures, including some relatively acute curvatures (e.g., the native aortic arch (see FIGS. 16-19)). When the delivery device is curved, some of the shafts within the delivery device follow different path lengths than other shafts of the delivery device. The path length of a shaft can vary depending on the radial distance from the neutral axis. For example, in the case of delivery device 200, the central longitudinal axes of the first shaft 204 and the second shaft 206 form the neutral axis. Thus, the first shaft 204 and the second shaft 206 follow the same length when extending across a curvature because the first shaft 204 and the second shaft 206 are coaxial and concentric. As shown in FIG. 9, the actuating shaft 210 is radially outwardly spaced from the central longitudinal axes of the first shaft 204 and the second shaft 206. In other words, the actuating shaft 210 is non-coaxial and eccentric with respect to the first shaft 204 and the second shaft 206. Thus, when the delivery device 200 is disposed across a curvature, each actuating shaft 210 follows a different path length. If all of the actuating shafts 210 have the same length, the different path lengths can result in non-uniform tension within each of the actuating shafts 210 and / or the actuating shafts 210 can be stretched. The non-uniform tension and / or stretching in these actuating shafts 210 is undesirable because it results in a non-uniform force distribution across the actuating shaft and / or non-uniform variation in the actuating shaft. The non-uniform force in the actuating cable can result in excessive force on one or more of the actuating shafts 210, which in some instances can cause damage to the actuator 106 and / or the actuating shaft 210. For example, the non-uniform displacement of the actuating cable can result in non-uniform radial expansion of the prosthetic heart valve. Accordingly, it is desirable to reduce or prevent the non-uniform force and / or non-uniform displacement in these actuating shafts.

[0074] Disclosed herein are various control mechanisms and multi-lumen shafts configured to control the force and / or displacement of an actuating shaft even when the actuating shaft is curved. In some examples, these control mechanisms can be coupled to an expansion mechanism and / or a release mechanism of a delivery device. The control mechanisms of the present disclosure can be effective, for example, in evenly distributing the load on the actuating shaft. Additionally or alternatively, the control mechanisms of the present disclosure can also adjust the length of the actuating shafts relative to each other such that the artificial valve expands evenly when the expansion mechanism is actuated. The control mechanisms disclosed herein can be used, for example, with a delivery device 200.

[0075] Generally, the control mechanisms of the present disclosure operate by allowing one end (e.g., the proximal end portion) of the actuating shaft to move relative to other components of the delivery device rather than having both ends of the actuating shaft fixed. By doing so, the actuating shaft can "float" when the delivery device is curved, thereby preventing non-uniform tension and / or elongation in the actuating 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 actuating 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 actuating shaft. These pulleys allow the proximal end portions of the actuating shaft to move relative to each other, thereby evenly distributing the load on the actuating shaft. In some embodiments, the force control mechanism can be coupled to the actuating 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 comprise one or more gear assemblies coupled to the actuating shaft of the delivery device. These gear assemblies can be configured to move the actuating shaft axially and / or rotationally relative to other components of the delivery device and / or the artificial heart valve. By doing so, the displacement mechanism can be used, for example, to expand the artificial heart valve and / or to release the artificial heart valve from the delivery device. In certain embodiments, the displacement control mechanism can be coupled to the actuating mechanism and / or the release mechanism of the delivery device.

[0078] In other embodiments, a multi-lumen shaft having a plurality of helical lumens can be provided. These helical lumens can be configured to receive respective actuating shafts of the delivery device. For example, the helical lumens can be effective to ensure that the actuating shafts move the same distance or a substantially same distance even when the multi-lumen shaft is curved. Thus, the multi-lumen shafts disclosed herein can be effective, for example, to ensure 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 having helical lumens. In other examples, the delivery device can comprise a force control mechanism but omit the displacement control mechanism and / or the multi-lumen shaft having helical lumens. In yet other embodiments, the delivery device can comprise various other combinations and / or sub-combinations of a force control mechanism, a displacement control mechanism, and / or a multi-lumen shaft having helical lumens.

[0080] FIG. 20 shows a force control mechanism 400 according to an embodiment. As shown, in some examples, this force control mechanism 400 can be a component of the delivery device 200. In some of such examples, the force control mechanism can be housed, for example, within the handle 202 of the delivery device 200. The force control mechanism 400 is coupled to the actuating shaft 210 and the actuating mechanism 220 and can be disposed between the actuating shaft 210 and the actuating mechanism 220. By doing so, the force control mechanism 400 can be used to evenly distribute the force in the actuating shaft 210 and / or the force applied to the actuating shaft 210.

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

[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, and the base member 410 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 a flexible cord, wire, cable, suture, 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 actuating shaft 210a and a second end portion 412b coupled to the proximal end portion of the second actuating 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 actuating shaft 210c and a second end portion 414b coupled to the actuating mechanism 220.

[0084] In other embodiments, it is possible for the force control mechanism not to have these connecting members. In such embodiments, the first actuating shaft 210a and the second actuating shaft 210b can be integrally formed or directly coupled together. Also, the third actuating shaft 210c can be directly coupled to the actuating 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 axial relative movement between the carriage 408 and the housing 228. In some examples, friction reducing elements (such as bearings, wheels, rollers, lubricants, slippery materials, etc.) are disposed between the carriage 408, the track 416, and / or the housing 228 to assist the carriage 408 in moving more easily relative to the track 416 and / or the housing 228.

[0086] During operation, the proximal end portions of the first operating shaft 210a and the second operating shaft 210b can move freely axially relative to each other by means of the first connecting member 412 and the first dynamic pulley 402. Therefore, the difference in force (e.g., tension) between the first operating shaft 210a and the second operating shaft 210b will be balanced by the axial movement of the proximal end portions of the first operating shaft 210a and the second operating shaft 210b relative to each other. Also, the proximal end portion of the third operating shaft 210c can move freely axially relative to the proximal end portion of the first operating shaft 210a and / or the second operating shaft 210b by means of the second connecting member 414, the second dynamic pulley 404, the static pulley 406, and the carriage 408. Therefore, the difference in force between the third operating shaft 210c and the first operating shaft 210a and / or the second operating shaft 210b will be balanced by the axial movement of the proximal end portions of the operating shafts 210 relative to each other.

[0087] Also, when the actuating mechanism 220 is actuated to expand the artificial valve 100 and the tension increases in the second connecting member 414, the force control mechanism 400 evenly distributes the tension acting on the second connecting member 414 between the operating shafts 210 by enabling the proximal end portions of the operating shafts 210 to move axially relative to each other. For example, as shown in FIG. 20, the proximal end portions of each operating shaft 210 are located at different axial positions relative to the handle 202.

[0088] The uniform force distribution between the operating shafts can be effective in ensuring that none of the operating shafts are subjected to excessive loads that could result in non-uniform expansion of the artificial valve and / or damage to the operating shafts (e.g., damage to the threaded portion 242 located at the distal end portion of the operating shaft 210). As a result, for example, the force control mechanism can improve the functionality, safety, and / or reliability of the delivery device.

[0089] FIG. 21 shows a portion of a delivery device 500 according to another embodiment. The delivery device 500 includes a handle 502 and a plurality of actuating shafts 504a-504d (collectively or generally referred to as "actuating shafts 504"). The delivery device 500 also includes a force control mechanism 506 and an actuating mechanism 508. The actuating shafts 504 are coupled to the handle 502 via the force control mechanism 506 and the actuating mechanism 508. The force control mechanism 506 and the actuating mechanism 508 are configured substantially the same as the force control mechanism 400 and the actuating mechanism 220, respectively, except that the force control mechanism 506 is configured to balance the forces of four actuating shafts rather than three actuating shafts.

[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 connecting member 524, a second connecting member 526, a third connecting member 528, a base member 530, and an anchor 532. The first dynamic pulley 510 and the second dynamic pulley 512 are rotatably attached to the first carriage 520, and the first carriage 520 is movably coupled to the handle 502. The third dynamic pulley 514 and the fourth dynamic pulley 516 are rotatably attached to the second carriage 522, and the second carriage 522 is also movably coupled to the handle 502. The static pulley 518 is rotatably attached to the base member 530, and the base member 530 is fixedly coupled to the handle 502. The first connecting member 524 extends around the first dynamic pulley 510, with a first end portion coupled to the proximal end portion of the first actuating shaft 504a and a second end portion coupled to the proximal end portion of the second actuating shaft 504b. The second connecting member 526 extends around the third dynamic pulley 514, with a first end portion coupled to the proximal end portion of the third actuating shaft 504c and a second end portion coupled to the proximal end portion of the fourth actuating shaft 504d. The third connecting member 528 extends from the actuating mechanism 508 around the second dynamic pulley 512, around the static pulley 518, around the fourth dynamic pulley 516 to the anchor 532. The anchor 532 is fixedly coupled to the handle 502.

[0091] The first connecting member 524 and the first dynamic pulley 510 enable the proximal end portions of the first actuating shaft 504a and the second actuating shaft 504b to move axially relative to each other. Thereby, the force is evenly distributed between the first actuating shaft 504a and the second actuating shaft 504b. The second connecting member 526 and the third dynamic pulley 514 enable the proximal end portions of the third actuating shaft 504c and the fourth actuating shaft 504d to move axially relative to each other. Thereby, the force is evenly distributed between the third actuating shaft 504c and the fourth actuating shaft 504d. The third connecting member 528, the second dynamic pulley 512, the fourth dynamic pulley 516, the static pulley 518, and the anchor 532 enable the first carriage 520 and the second carriage 522 to move axially relative to each other, and further thereby, the proximal end portions of the first actuating shaft 504a and the second actuating shaft 504b can move axially relative to the proximal end portions of the third actuating shaft 504c and the fourth actuating shaft 504d. Thereby, the force is evenly distributed among all the actuating shafts 504.

[0092] In other embodiments, the force control mechanism 506 can have no connecting members, and these actuating shafts can be directly coupled together and / or directly coupled to other components of the delivery device 500.

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

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

[0095] By the cooperation of these components of the force control mechanism 606, the proximal end portions of the actuating shafts 604 can move axially relative to each other in a manner similar to that described above in relation to the force control mechanisms 400 and 506. As a result, the force is evenly distributed between the actuating shafts 604.

[0096] The force control mechanisms 400, 506, and 606 are each configured for a delivery device having three, four, or five actuating shafts. In other embodiments, the force control mechanism can be configured for use with a delivery device having two or fewer (e.g., two) or six or more (e.g., 6 - 15) actuating shafts.

[0097] FIG. 23 shows 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 enables all of the actuating shafts 210 to be simultaneously moved axially (e.g., to expand an artificial valve). Also, the displacement control mechanism 700 allows all of the actuating shafts to be simultaneously released (e.g., when disconnecting an artificial valve from the delivery device). Further, when the actuating shafts follow different path lengths (e.g., when these actuating shafts bend at a curved portion), the proximal end portions of the actuating shafts of the delivery device can move axially relative to each other by the displacement control mechanism 700.

[0098] In the illustrated embodiment, the displacement control mechanism 700 includes three main components, namely a coupling member 702, an actuating member 704, and a gear assembly 706. The coupling member 702 of the displacement control mechanism 700 is disposed near the distal end portion of the shaft 206 of the delivery device 200 and is coupled to the actuating shaft 210 of the delivery device 200. Note that the shaft 206 is shown as being transparent for illustrative purposes. The actuating member 704 of the displacement control mechanism 700 extends through the shaft 206, is coupled to the coupling member 702 of the displacement control mechanism 700 at the distal end portion of the actuating member 704, and is coupled to the actuating mechanism 220 of the delivery device 200 at the proximal end portion of the actuating 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 actuating shaft 210 and to the release mechanism 222 of the delivery device 200. By doing so, the axial movement of the actuating member 704 relative to the shaft 206 axially moves the coupling member 702 and the actuating shaft 210 (e.g., to expand the prosthetic valve), and the rotational movement of the gear assembly 706 relative to the shaft 206 rotates the actuating shaft 210 (e.g., to release the prosthetic valve from the delivery device 200). Further details regarding the displacement control mechanism 700 and its components are presented hereinafter.

[0099] Referring to FIG. 24, the coupling member 702 of the displacement control mechanism 700 includes a cylindrical body or a disk-shaped body. In other embodiments, the coupling member may include various other shaped bodies (e.g., a cube, a prism, etc.).

[0100] A plurality of openings 708 extend axially through the coupling member 702. As shown in FIG. 26, the opening 708 of the coupling member 702 is configured such that the actuating shaft 210 extends through the coupling member 702 and can rotate freely relative to this coupling member 702.

[0101] Referring to FIG. 26, a plurality of stopper members 170 are provided to limit the axial relative movement between the coupling member 702 and the actuating shaft 210. These stopper members 710 are fixedly coupled to the actuating shaft 210 at positions adjacent to the surface facing the proximal direction and the surface facing the distal direction of the coupling member 702 (e.g., by fasteners, adhesives, welding, frictional engagement, etc.). The stopper member 710 is larger in the radial direction than the opening 708 of the coupling member 702. As a result, the stopper member 710 abuts against the surface facing the proximal direction and the surface facing the distal direction of the coupling member 702, thus restricting the axial relative movement between the actuating shaft 210 and the coupling member 702.

[0102] As shown in FIGS. 25-26, the distal end portion of the actuating member 704 is coupled to the coupling member 702. Accordingly, axial movement of the actuating member 704 results in axial movement of the coupling member 702 and thus the actuating shaft 210. For example, FIG. 25 shows the actuating member 704, the coupling member 702, and the actuating shaft 210 in a proximal position where the coupling member 702 abuts against 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. Also, the manifold 248 functions as a distal stopper for the coupling member 702.

[0103] The actuating member 704 can be coupled to the coupling member 702 in various ways including tying, fastening, adhesives, embedding, etc. Although not shown, in some embodiments, the coupling member 702 can include mounting elements (e.g., bores, openings, eyelets, etc.) configured to facilitate the mounting of the actuating member 704 to the coupling member 702.

[0104] As schematically shown in FIG. 23, the proximal end portion of the actuating member 704 is coupled to the actuating mechanism 220 of the handle 202. In some embodiments, the actuating mechanism 220 can include a spool or other device configured to draw in and release the actuating member 704, which can be used to raise and lower the tension of the actuating member 704. The actuating mechanism 220 can have a first mode of operation that raises the tension acting on the actuating member 704 and thus moves the actuating member 704, the coupling member 702, and the actuating shaft 210 proximally relative to the support sleeve 208. Thus, the first mode of operation can be utilized, for example, to radially expand an artificial valve (e.g., artificial valve 100) coupled to the distal end portion of the actuating shaft 210. The actuating mechanism 220 can have a second mode of operation that lowers the tension acting on the actuating member 704 and moves (or enables movement of) the actuating member 704, the coupling member 702, and the actuating shaft 210 distally. Accordingly, the second mode of operation can be utilized, for example, to radially compress an artificial valve (e.g., artificial valve 100) coupled to the distal end portion of the actuating shaft 210. By doing so, advantageously, the displacement control mechanism 700 enables simultaneous axial movement of all the actuating shafts 210, and further enables simultaneous actuation of the actuators 106 of the artificial valves 100. This can improve, for example, the uniform expansion of the artificial valves.

[0105] Figures 27-31 show the gear assembly 706 of the displacement control mechanism 700 and its components. Referring first to FIGS. 30 and 31, the gear assembly 706 includes a plurality of inner gears 712 and an outer gear 714 surrounding the inner gears 712. The inner gears 712 are coupled to the proximal end portion of the actuating shaft 210. The inner gears 712 and the proximal end portion of the actuating shaft 210 are axially movable relative to the outer gear 714. The outer gear 714 engages each inner gear 712 such that rotation of the outer gear 714 about its central longitudinal axis results in rotation of the inner gears 712 about their respective longitudinal axes. By doing so, the gear assembly 706 can be used to simultaneously rotate each actuating shaft 210 relative to the shaft 206, such as when coupling an artificial valve to the delivery device 200 and / or decoupling the artificial valve from the delivery device 200.

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

[0107] Instead of or in addition to the axial opening 720, the radial opening 721, and / or the fixing element 722, the inner gear 712 can be fixed to the drive shaft in various other ways. For example, the inner gear 712 can be fixed to the drive shaft 210 via an adhesive, welding, and / or other coupling means. Additionally or alternatively, in some embodiments, each drive shaft 210 can include a "flat portion" (i.e., a segment having a "D-shaped" cross-sectional profile in a plane perpendicular to the longitudinal axis of the drive shaft). This flat portion of the drive shaft is axially aligned with the radial opening 721 of the inner gear 712 such that the fixing element 722 engages the flat portion of the drive shaft (rather than the circular portion of the drive shaft), thereby enhancing the restriction on the relative rotational movement between the drive shaft and the inner gear. Additionally or alternatively, the axial openings 720 of the drive shaft and the inner gear 712 can have corresponding non-circular cross-sectional shapes (e.g., D-shaped, square-shaped, triangular-shaped, star-shaped / gear-shaped, etc.), and these shapes can engage with each other to restrict the relative rotational movement between the drive shaft and the inner gear.

[0108] The teeth 718 of the inner gear 712 extend radially outward from the mounting portion 716. As shown in FIG. 30, the teeth 718 of the inner gear 712 mesh with the corresponding radially inward-facing teeth 724 of the outer gear 714. The inner gear 712 of the displacement control mechanism 700 and the drive shaft 210 of the delivery device 200 can be mounted within the handle 202 of the delivery device 200 such that the inner gear 712 and the drive shaft 210 can rotate about their respective central axes but cannot move circumferentially relative to the outer gear 714 (i.e., cannot move in an orbital path). Thus, when the outer gear 714 rotates about its central axis relative to the handle 202 of the delivery device 200, rotation of the inner gear 712 and the drive shaft 210 about their respective central axes relative to the handle 202 (and the shaft 206) results.

[0109] Since the inner gear 712 has a diameter smaller than that of the outer gear 714, when the outer gear 714 rotates once about its central axis, the inner gear 712 rotates more than once about their respective central axes as a result. By changing 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] Also, the inner gear 712 and the actuating shaft 210 can be mounted within the handle 202 of the delivery device 200 such that the proximal end portions of the inner gear 712 and the actuating shaft 210 can move axially relative to the outer gear 714 and relative to each other. Advantageously, this can enable the actuating shaft 210 to be adjusted to various path lengths by a curvature in the shaft 206 (such as when curving around the aortic arch). For example, FIG. 31 shows two actuating shafts 210 and inner gears 712 each located at different axial positions. When the shaft 206 is curved (see, for example, FIG. 23), a first actuating shaft positioned at the outer portion of this curvature follows a longer path length than a second actuating shaft positioned at the inner portion of this curvature. Thus, as shown in FIG. 31, the proximal end portion of the first actuating shaft can move distally relative to the outer gear (and, assuming the actuating shafts are all of the same length, relative to other actuating shafts and inner gears), and / or the proximal end portion of the second actuating shaft can move proximally relative to the outer gear (and other actuating shafts and inner gears). When the shaft 206 is straight, the proximal end portions of the actuating shafts can move axially relative to the outer gear 714 and can be axially aligned with each other.

[0111] To accommodate axial movement of the proximal end portion of the actuating shaft 210 and the inner gear 712, the outer gear 714 may have an axial length L1 that is greater than the axial length L2 of the teeth 718 of the inner gear 712. Thereby, the teeth 718 of the inner gear 712 remain in an engaged state even when the components move axially relative to the teeth 724 of the outer gear 714. The length L1 of the outer gear 714 may be set to correspond to the maximum change in the length of the actuating shaft. In other words, the ratio of the length L1 of the outer gear 714 to the length L2 of the inner gear 712 may vary based on the curvature of the shaft 206 and / or the circumferential position of the actuating shaft 210 relative to the curved portion (e.g., when torque is applied to the shaft 206), and is set such that the teeth 718 of the inner gear 712 remain in an engaged state with the teeth 724 of the outer gear 714 regardless of the axial position of the inner gear 712. For example, in some embodiments, the ratio of the lengths L1 and L2 can be between 1.5 and 10. In certain embodiments, the ratio of the lengths L1 and L2 can be between 2 and 6. In some embodiments, the ratio of the lengths L1 and L2 can be between 3 and 5. In still other embodiments, the ratio of the lengths L1 and L2 can be between 4 and 4.5.

[0112] Delivery device 200 including a displacement control mechanism 700 can be used for implanting an artificial valve. For example, as shown in FIG. 1, the operating shaft 210 of the delivery device 200 is releasably (e.g., threadably) coupled to each rack member 120 of the artificial valve 100, and the support sleeve 208 of the delivery device 200 abuts against each housing member 122 of the actuator 106, so that the artificial valve 100 can be coupled to the delivery device 200. Similar to the manner described above in connection with FIGS. 16-19, the artificial valve 100 and the delivery device 200 are inserted into a patient's body, and the delivery device 200 can be used to deploy and implant the artificial valve 100 within the patient's body. Specifically, when the artificial valve 100 and the delivery device 200 are advanced through the patient's vasculature, the shaft 206 can curve through the patient's vasculature to the implantation position. When the shaft 206 curves, the displacement control mechanism 700 allows the proximal end portion (and the inner gear 712) of the operating shaft 210 to move axially relative to each other and relative to the outer gear 714, corresponding to different path lengths of the operating shafts 210. During such movement, the inner gear 712 remains engaged with the outer gear 714.

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

[0114] Optionally, the artificial valve 100 can be recompressed for repositioning and / or retrieval.

[0115] Once the artificial valve 100 is positioned and fixed as desired within the patient's body, the artificial valve 100 can be released from the delivery device 200. This can be achieved, for example, by actuating the gear assembly 706 of the displacement control mechanism 700 by operating the release mechanism 222 of the delivery device 200. When the gear assembly 706 is actuated, the outer gear 714 rotates about its central axis relative to the handle 202, whereby the inner gears 712 are rotated about their respective central axes. As a result, the actuating shaft 210 is rotated relative to the rack member 120 of the artificial valve 100, whereby the threaded portion 242 of the actuating shaft 210 is withdrawn from the thread of the rack member 120, thereby releasing the artificial valve 100 from the delivery device 200.

[0116] Therefore, by configuring the displacement control mechanism 700 in this way, the user can simultaneously move a plurality of actuating shafts (e.g., the actuating shaft 210) axially via a single actuating member (e.g., the actuating member 704). Further, since the proximal end portions of the actuating shafts 210 can move axially relative to each other, when the actuating member 704 is moved axially, the distal end portions of all the actuating shafts move a constant (or substantially constant) distance, which is ensured by this displacement control mechanism 700. This can be effective in ensuring that the artificial valve expands evenly radially, even, for example, when the delivery device has a curved configuration. Also, the displacement control mechanism 700 can simplify the actuation mechanism by having a single actuating member. Further, with the displacement control mechanism 700 of the present disclosure, these actuating shafts 210 can be simultaneously rotated via the gear assembly 706. Thereby, for example, it may be possible to quickly and easily release the artificial valve from the delivery device.

[0117] Figures 32 to 34 show a displacement control mechanism 800 according to another embodiment. Referring to FIG. 33, the displacement control mechanism 800 (FIG. 32) includes a coupling member 802, an actuating member 804, and a gear assembly 806. Generally, the displacement control mechanism 800 is configured and operates in the same manner as the displacement control mechanism 700. One difference between the displacement control mechanism 800 and the displacement control mechanism 700 is that the gear assembly 806 of the displacement control mechanism 800 is disposed not in the handle 202 like the gear assembly 706 of the displacement control mechanism 700 (see FIG. 23), but at the distal end portion of the delivery device 200 (see FIG. 32). Note that the shaft 206 is omitted from FIG. 34 for illustrative reasons.

[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. Referring to FIG. 32, the coupling member 802 of the displacement control mechanism 800 is disposed within the distal end portion of the shaft 206 of the delivery device 200. For illustrative reasons, 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 actuating shaft 210 of the delivery device 200. The actuating 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. The proximal end portion of the actuating member 804 is coupled to the actuating mechanism 220 and the release mechanism 222 of the delivery device 200, and these actuating mechanism 220 and release mechanism 222 are coupled to the handle 202 and / or disposed within the handle 202. The gear assembly 806 of the displacement control mechanism 800 is disposed within the distal end portion of the shaft 206. In other embodiments, the gear assembly 806 may be disposed adjacent to the distal end portion of the shaft 206 rather than within the shaft 206.

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

[0120] The coupling member 802 may comprise a plurality of apertures (not shown) extending axially therethrough (e.g., similar to the apertures 708 of the coupling member 702). Referring to FIG. 33, the apertures of the coupling member 802 are configured such that the actuating shaft 210 extends through the coupling member 802 and is free to rotate relative to the coupling member 802.

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

[0122] In the illustrated embodiment, the actuating shaft 210 passes through the support sleeve 208 from a position distal to the support sleeve 208, through the coupling member 802, through the peripheral gear 808, through the shaft 206, and extends to the handle 202. In such an embodiment, the proximal end portions of the actuating shaft 210 can move axially relative to each other and relative to the handle 202. Thereby, the actuating shaft 210 can move axially relative to each other, thereby corresponding to various path lengths of each actuating shaft (for example, when the actuating shaft bends around a curved portion). Also, by moving a single component (i.e., the actuating member 804), as a result, even when the proximal end portions of each actuating shaft 210 are different from each other, all the actuating shafts move simultaneously (via the coupling member 802) over a constant (or at least substantially constant) distance. 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 in a curved configuration.

[0123] In other embodiments, the actuating shaft 210 can be relatively short. In such an embodiment, the distal end portion of the actuating shaft 210 extends beyond the distal end of the support sleeve 208, and the proximal end portion of the actuating shaft 210 can be coupled to the peripheral gear 808 of the displacement control mechanism 800. The relatively short length of the actuating shaft reduces the likelihood that the actuating shaft will be positioned along a curved portion in the patient's anatomical structure during expansion of the prosthetic valve. This reduces the need to still achieve uniform expansion of the prosthetic valve while allowing the actuating shafts to move axially relative to each other.

[0124] The actuating member 804 is fixedly coupled to the central gear 810 of the gear assembly 806. Accordingly, the actuating member 804 and the central gear 810 both move axially and rotate together. The central gear 810 is coupled to the coupling member 802 such that it can rotate relative to the coupling member 802 and is restricted from moving axially relative to the coupling member 802. For example, in some embodiments, the central gear 810 can be attached to the coupling member 802 via a bearing.

[0125] The actuating shaft 210 and the actuating member 804 can be coupled to the peripheral gear 808 and the central gear 810 respectively in various manners. For example, such coupling manners include fasteners 812, adhesives, welding, and / or other coupling means. In some embodiments, the actuating shaft 210, the actuating member 804, and / or the gears 808, 810 can be provided with non-circular mating features (such as flats on the actuating shaft 210 and / or the actuating member 804) to facilitate these couplings and / or to prevent relative movement in the rotational direction.

[0126] In the illustrated embodiment, the gear assembly 806 is disposed on the proximal side of the coupling member 802. In other embodiments, the gear assembly 806 can be disposed on the distal side of the coupling member 802. In such embodiments, the coupling member 802 can be provided with a central opening configured such that the actuating member 804 can pass through and extend therein and rotate internally. The central gear 810 can prevent the actuating member 804 from moving proximally relative to the coupling member 802, and a stopper member can be disposed on the proximal side of the coupling member 802 to prevent the actuating member 804 from moving distally relative to the coupling member 802.

[0127] The peripheral gears 808 of the gear assembly 806 are provided with teeth that mesh with the teeth of the central gear 810 of the gear assembly 806. It should be noted that the rotation of the peripheral gears 808 (i.e., the movement along an orbit) is restricted around the central axis of the central gear 810. Therefore, when the central gear 810 rotates about its axis, as a result, the peripheral gears 808 are rotated about their respective axes. When the central gear 810 rotates about its axis in a first direction (e.g., clockwise), the peripheral gears 808 are, as a result, rotated about their respective axes in a second direction (e.g., counterclockwise), and vice versa.

[0128] An artificial valve (e.g., artificial valve 100) can be coupled to a delivery device 200 having a displacement control mechanism 800 in a manner similar to that shown in FIG. 13. The artificial valve 100 can be compressed and loaded into the shaft 206 (see FIGS. 14-15). The artificial valve 100 can be inserted into a patient's vasculature, advanced to or near an implantation position, and deployed from the shaft 206 (see FIGS. 16-17). The artificial valve 100 can be expanded by moving the actuating member 804 of the displacement control mechanism 800 proximally relative to the shaft 206, such that the coupling member 802 and the actuating shaft 210 are moved relative to the shaft 206, and the rack member 120 of the actuator 106 is moved relative to the housing member 122 of the actuator, thereby expanding the frame 102 of the artificial valve 100. The actuating member 804 can be moved proximally by actuating the actuating mechanism 220 and / or by manually moving the actuating member 804 proximally relative to the handle 202. When the artificial valve 100 is expanded and fixed at the implantation position (e.g., within the native valve annulus), the artificial valve 100 can be released from the delivery device 200 by rotating the actuating member 804 of the displacement control mechanism 800 about its axis relative to the shaft 206, whereby the central gear 810 is rotated about its axis, and further the peripheral gear 808 and the actuating shaft 210 are rotated about their axes. Thereby, the actuating shaft 210 is decoupled from the rack member 120 of the actuator 106. The actuating member 804 can be rotated by actuating the release mechanism 222 and / or by manually rotating the actuating member 804 relative to the handle 202.

[0129] Figures 35-40 show a displacement control mechanism 900 and its components according to another embodiment. Similar to the displacement control mechanisms 700 (and 800) and the force control mechanisms 400, 506, 606, the displacement control mechanism 900 enables the proximal end portions of the operating shafts of the delivery device to move axially relative to each other. Thus, the displacement control mechanism 900 is effective to ensure that these operating shafts move the actuator of the prosthetic valve over a certain distance and uniformly expand the prosthetic valve. With the displacement control mechanism 900, these operating shafts can be moved simultaneously in the axial direction, which can also be effective to ensure uniform expansion of the prosthetic valve. Further, with the displacement control mechanism 900, these operating shafts can be rotated simultaneously and thus released from the actuator of the prosthetic valve.

[0130] As shown in FIG. 35, the displacement control mechanism 900 can be coupled to and / or disposed within the handle of the 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 operating shaft 210 and is configured to convert the rotational movement of the first gear assembly 902 into axial movement of the operating shaft 210 (e.g., to expand the prosthetic valve). Thus, 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 operating shaft 210 and is configured such that rotation of the second gear assembly 904 results in rotation of the operating shaft 210 (e.g., to release the prosthetic valve from the delivery device). Accordingly, the second gear assembly 904 can also be referred to as a "release gear assembly".

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

[0132] Referring further to FIG. 36, the first outer gear 906 has an axial length longer than the axial length of the first inner gear 908. Thereby, the first inner gear 908 can remain engaged with the first outer gear 906 when the proximal end portion of the operating shaft 210 is axially moved relative to the first outer gear 906 (for example, when the delivery device is curved and the operating shafts follow different path lengths).

[0133] The first inner gear 908 can be coupled to each operating shaft 210 such that relative rotational movement between the first inner gear 908 and the operating shaft 210 results in relative axial movement between the first inner gear 908 and the operating shaft 210. For example, as shown in FIG. 39, the first gear assembly 900 includes inserts 910 fixedly coupled to the respective first inner gears 908. These inserts 910 include threaded bores 912 configured to engage corresponding threaded portions on the proximal end portions of the operating shafts 210.

[0134] The first inner gear 908 and the insert 910 can be coupled together in a manner configured to limit relative rotational and / or axial movement therebetween. For example, the first inner gear 908 and the insert 910 can be coupled together using an adhesive, welding, mating features, and / or other coupling means. For example, as shown in FIGS. 37-39, the first inner gear 908 and the insert 910 include mating features configured to limit relative rotational movement therebetween. Specifically, each of the first inner gears 908 includes a non-circular (e.g., square) opening 914 corresponding to the non-circular (e.g., square) outer surface of the insert 910. Further, each of the first inner gears 908 includes a slot 915 configured to receive a corresponding tab 917 of the insert 910. These non-circular shapes, and / or the slots and tabs, limit relative rotational and / or axial movement between the first inner gear 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" couplings) can be used to limit relative rotational and / or axial movement between the first inner gear 908 and their respective inserts 910.

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

[0136] The threaded portion between the proximal end portion of the actuating shaft 210 and the threaded bore 912 of the insert 910 can be configured such that when the gears 906, 908 rotate in a desired rotational direction (e.g., clockwise direction / counterclockwise direction), as a result, the actuating shaft 210 is moved in a desired axial direction (e.g., proximal direction / distal direction). For example, in some embodiments, the threaded portion between the proximal end portion of the actuating shaft 210 and the threaded bore 912 of the insert 910 can be a right-handed thread. In such embodiments, by rotating the gears 906, 908 in the clockwise direction, the actuating shaft is moved in the proximal direction (e.g., to radially expand the prosthetic valve), and by rotating the gears 906, 908 in the counterclockwise direction, the actuating shaft is moved in the distal direction (e.g., to radially contract the prosthetic valve). In other embodiments, the threaded portion between the proximal end portion of the actuating shaft 210 and the threaded bore 912 of the insert 910 can be a left-handed thread. In such embodiments, by rotating the gears 906, 908 in the counterclockwise direction, the actuating shaft is moved in the proximal direction (e.g., to radially expand the prosthetic valve), and by rotating the gears 906, 908 in the clockwise direction, the actuating shaft is moved in the distal direction (e.g., to radially contract the prosthetic valve).

[0137] Instead of the insert 910, the first inner gear 908 can be provided with a threaded bore configured to directly engage a corresponding threaded portion on the proximal end portion of the actuating shaft 210. In yet other embodiments, the proximal end portion of the actuating shaft 210 can have a threaded member (e.g., a sleeve) fixedly coupled (e.g., using an adhesive, welding, fasteners, etc.). These threaded members can be configured to threadedly engage the respective threaded bores 912 of the insert 910 or the respective threaded bores of the first inner gear 908.

[0138] To change the axial distance by which the actuating shaft moves with each rotation of the inner gears 908, various thread pitches or number of threads ("TPI (threads per inch)") can be used for the proximal end portion of the actuating shaft 210 and the threaded portion of the threaded bore 912 of the insert 910. For example, a lower thread pitch / higher number of threads results in a smaller axial movement of the actuating shaft per rotation of the inner gear 908. In contrast, a higher thread pitch / lower number of threads results in a greater axial movement of the actuating shaft per rotation of the inner gear 908.

[0139] Also, various diameters and / or gear ratios of the gears 906, 908 can be used to change the axial distance by which the actuating shaft 210 moves with each rotation of the gears 906, 908.

[0140] As shown in FIG. 40, the second gear assembly 904 of the displacement control mechanism 900 includes a second outer gear 916 and a plurality of second inner gears 918 disposed within and engaged with the second outer gear 916. Generally, the second gear assembly 904 of the displacement control mechanism 900 is configured such that the proximal end portion of the actuating shaft 210 can move axially so as to correspond to different path lengths (e.g., due to curvature in the shaft 206) along which these actuating shafts move, and such that the actuating shaft can be simultaneously rotated (e.g., to release the artificial valve from the delivery device) when the second outer gear 916 rotates, and can be configured and function in a manner similar to the gear assembly 706 of the displacement control mechanism 700.

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

[0142] Referring again to FIG. 40, the second outer gear 916 can have an axial length that is longer than the axial length of the second inner gear 918. Thereby, the second inner gear 918 remains engaged with the second outer gear 916 when the proximal end portion of the actuating shaft 210 moves axially relative to the second outer gear 916 (e.g., due to different path lengths that the actuating shaft moves).

[0143] The second inner gear 918 can be fixedly coupled to the respective actuating shaft 210 such that the second inner gear 918 and the actuating shaft 210 move together both axially and rotationally. The second inner gear 918 can be fixedly coupled to the actuating shaft 210 in a variety of ways including fasteners (e.g., set screws and / or key connections), welding, adhesives, mating non-circular shapes, and / or other coupling means.

[0144] The second gear assembly 904 can be used to disengage the actuating shaft 210 from the prosthetic valve / couple the actuating shaft 210 to the prosthetic valve. For example, by rotating the gears 916, 918 in a first direction (e.g., clockwise), the actuating shaft 210 is rotated in the first direction such that the threaded portion 242 on the distal end portion of the actuating shaft 210 can engage the threaded portion of the rack member of the prosthetic valve (e.g., when the threaded portions of the distal end portion of the actuating shaft and the rack member are right-handed threads). By rotating the gears 916, 918 in a second direction (e.g., counterclockwise), the actuating shaft 210 is rotated in the second direction such that the threaded portion 242 on the distal end portion of the actuating shaft 210 can be disengaged from the threaded portion of the rack member of the prosthetic valve (e.g., when the threaded portions of the distal end portion of the actuating shaft and the rack member are right-handed threads).

[0145] During rotation of the first gear assembly 902 (e.g., when expanding / contracting the prosthetic valve), the second gear assembly 904 can be prevented from rotating with the first gear assembly 902. This can be achieved either actively (e.g., using a locking mechanism) or passively (e.g., by sufficient static friction in the second gear assembly 904). Accordingly, the second gear assembly 904 is effective to prevent the actuating shaft 210 from rotating with the first inner gear 908 and the insert 910 of the first gear assembly 902, which can further facilitate axial movement of the actuating shaft 210 relative to the insert 910 due to the threaded connection between the actuating shaft 210 and the insert 910. Also, when the proximal end portions of the actuating shaft 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 actuating 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 proximal to the second gear assembly 904. In other embodiments, the first gear assembly 902 may be disposed distal to the second gear assembly 904.

[0147] Figures 41-42 show a sliding outer gear 1000 that can be used, for example, with a displacement control mechanism 900 instead of the first outer gear 906 and the second outer gear 916. This sliding outer gear 1000 is axially movable (slidable) between a first position and a second position. In the first position (Figure 41), the sliding outer gear 1000 engages the first inner gear 908 and disengages from the second inner gear 918. By rotating the sliding outer gear 1000 when it is in the first position (manually and / or via the actuation mechanism 220), the first inner gear 908 is rotated and the actuation shaft 210 is axially moved relative to the first inner gear 908 (e.g., to expand or contract an artificial valve). Thus, the first position may also be referred to as the "expansion position" or "expansion mode". In the second position (Figure 42), the sliding outer gear 1000 engages the second inner gear 918 and disengages from the first inner gear 908. By rotating the sliding outer gear 1000 when it is in the second position, the second inner gear 918 and further the actuation shaft 210 are rotated (e.g., to unlock / lock an artificial valve). Therefore, the second position may also be referred to as the "unlock position" or "unlock mode".

[0148] The sliding outer gear 1000 can provide a plurality of advantages. For example, the sliding outer gear 1000 can reduce the number of components of the displacement control mechanism 900. Also, the sliding outer gear 1000 can enhance safety by reducing the possibility that a user accidentally releases the artificial valve from the delivery device. For example, in some embodiments, the displacement control mechanism 900 can include a biasing member (such as a spring), a locking element (such as a switch and / or a groove), and / or other features configured to position and / or hold the sliding outer gear 1000 in an extended position (Figure 41) in an initial setting. To release the artificial valve, the user must intentionally move the sliding outer gear 1000 to a release position (Figure 42) by overcoming biasing, locking, etc., thereby reducing the possibility that the artificial valve is accidentally released.

[0149] Figures 43 to 47 show a displacement control mechanism 1100 according to yet another embodiment. As shown in Figure 43, the displacement control mechanism 1100 can be used, for example, together with a delivery device 200 or the like. The displacement control mechanism 1100 can be coupled to the proximal end portion of the operating shaft 210 of the delivery device 200 and can be disposed within the handle 202 of the delivery device 200. In one operating mode, the displacement control mechanism 1100 allows the proximal end portion of the operating shaft 210 to move axially relative to the displacement control mechanism 1100 and relative to each other (for example, when the operating shafts follow different path lengths due to the curvature of the operating shaft). In a second operating mode, the displacement control mechanism 1100 can be used to simultaneously move the operating shaft 210 axially relative to the shaft 206 and the support sleeve 208 (not shown) (for example, to expand / contract the artificial valve). In a third operating mode, the displacement control mechanism 1100 can be used to simultaneously rotate the operating shaft 210 relative to the shaft 206 and the support sleeve 208 (for example, to release / engage the artificial valve).

[0150] Referring further to FIG. 43, the displacement control mechanism 1100 includes a first gear assembly 1102 and a second gear assembly 1104. The first gear assembly 1102 can be coupled to and / or form components of the actuating mechanism 220 of the delivery device 200. The second gear assembly 1104 can be coupled to and / or form components 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 can 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 actuating shaft 210 is free to move (axially and / or rotationally) relative to the first gear assembly 1102 and axially relative to the second gear assembly 1104 (e.g., to allow the actuating shaft to be adjusted to different path lengths and / or to disengage / engage the prosthetic valve with the 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 actuating shaft 210 relative to the shaft 206 and the support sleeve 208 (e.g., to disengage / engage the prosthetic valve with the delivery device). When the first gear assembly 1102 is in the locked configuration, these actuating shafts 210 are fixed (axially and rotationally) relative to the first gear assembly 1102 and to each other, and the first gear assembly 1102 can be used to simultaneously move the actuating shaft 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 hereinafter.

[0153] Referring to FIGS. 43-44, the first gear assembly 1102 includes a front gear 1106, a plurality of first spur gears 1108 (e.g., three), a carriage member 1110, a plurality of lock screws 1112 (FIG. 46), and a drive screw 1114. The front gear 1106 and the spur gears 1108 each have teeth configured to mesh with each other, such that rotation of the front 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 lock screws 1112 (see FIG. 46). The carriage member 1110 can be selectively coupled to the actuating shaft 210 via the lock screws 1112 (see FIGS. 46-47). Also, the carriage member 1110 can be movably coupled to the drive screw 1114, such that rotation of 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 actuating shaft 210 if coupled to the carriage member 1110).

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

[0155] Referring to FIG. 44, the front gear 1106 has an annular shaped portion with a central opening 1116, the carriage member 1110 is disposed within this central opening 1116, and the actuating shaft 210 can extend axially through this central opening 1116. In particular, the central opening 1116 enables the front gear 1106 to rotate about its axis relative to the carriage member 1110 and the actuating shaft 210. The front gear 1106 can be rotated manually and / or via a motor 1118 (FIG. 43).

[0156] As shown in FIG. 46, each spur gear 1108 includes a central bore 1120 configured to receive a lock screw 1112. The spur gear 1108 also includes an annular shoulder extending radially inwardly into the central bore 1120. This shoulder is configured such that the shaft portion of the lock screw 1112 can extend beyond the shoulder and into the carriage member 1110. Further, this shoulder is configured to engage the head portion of the lock screw 1112 such that the head portion of the lock screw 1112 cannot completely penetrate the central bore 1120.

[0157] The lock screw 1112 is fixedly coupled to each respective spur gear 1108 such that the lock screw 1112 moves with (in the rotational direction and the axial direction) each respective spur gear 1108. For example, in some embodiments, the central bore of the spur gear can have a non-circular cross-sectional shape (e.g., square, hexagonal, etc.) and the head of the lock screw can have a corresponding non-circular cross-sectional shape. Additionally or alternatively, the lock screw can be fixedly coupled to each respective spur gear in a variety of other ways including fasteners (e.g., set screws), adhesives, welding, etc. In yet other embodiments, the lock screw and the spur gear can be integrally formed as a single unitary structure. For example, the lock screw can be a shaft portion with a screw portion extending from a single unitary spur gear portion. In such embodiments, the central bore 1120 can be omitted.

[0158] Referring to FIGS. 43 to 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 front 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 to 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 actuating shaft 210, and the actuating shaft 210 is configured to be freely movable 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 female threaded portions configured to engage corresponding male threaded portions of the lock screws 1112. By rotating the lock screws 1112 relative to the carriage member 1110, the lock screws 1112 move 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 configuration of the threaded portion (e.g., right-handed / left-handed). Thereby, the lock screws 1112 can engage or disengage from the actuating shaft 210, whereby the relative movement between the actuating shaft 210 and the carriage member 1110 is selectively restricted.

[0160] As shown in FIGS. 43 to 44, the connecting element 1126 of the carriage member 1110 includes an aperture having a female threaded portion configured to engage a corresponding male threaded portion of the drive screw 1114. Accordingly, as a result of the drive screw 1114 being rotated about its axis relative to the connecting element 1126, the carriage member 1110 is axially moved along the drive screw 1114.

[0161] As described above and referring 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 moving the lock screw 1112 radially with respect to the radial opening 1130 of the carriage member 1110. The lock screw 1112 can be moved radially by rotating the spur gear 1108 about its respective axis relative to the carriage member 1110. By means of a threaded connection, such rotation causes the lock screw 1112 to move relative to the carriage member 1110. The lock screw 1112 can be rotated relative to the carriage member 1110 by rotating the front gear 1106 about its axis relative to the carriage member 1110, thereby causing the spur gear 1108 and the lock screw 1112 to rotate together about their respective axes and relative to the carriage member 1110.

[0162] By rotating the front gear 1106 about its axis in a first direction (e.g., counterclockwise) relative to the carriage member 1110, as a result, the spur gear 1108 and the lock screw 1112 are rotated relative to the carriage member 1110 in the first direction about their respective axes. By rotating the lock screw 1112 counterclockwise relative to the carriage member 1110 (in the case of a right-hand thread configuration), the lock screw 1112 is retracted from the radial opening 1130 of the carriage member 1110. The lock screw 1112 can be retracted relative to the carriage member 1110 so as not to block the axial opening 1128 of the carriage member 1110 as shown in FIG. 46. This is the unlocked configuration of the first gear assembly 1102, whereby the actuating shaft 210 can move freely (axially and / or rotationally) relative to the carriage member 1110.

[0163] By rotating the spur gear 1106 about its axis in a second direction (e.g., clockwise) with respect to the carriage member 1110, as a result, the spur gear 1108 and the lock screw 1112 are rotated with respect to the carriage member 1110 in the second direction about their respective axes. When the lock screw 1112 is rotated clockwise with respect to the carriage member 1110 (in the case of a right-hand screw configuration), the lock screw 1112 advances into the radial opening 1130 of the carriage member 1110. As shown in FIG. 47, the lock screw 1112 contacts the actuating shaft 210 and can be advanced with respect to the carriage member 1110 so as to radially bias the actuating shaft 210 inwardly against the inner wall portion of the carriage member 1110 that defines the axial opening 1128. This is the locking configuration of the gear assembly 1102, whereby axial relative movement between the actuating shaft 210 and the carriage member 1110 is restricted by frictional engagement between the lock screw 1112, the actuating shaft 210, and the inner wall portion of the carriage member 1110.

[0164] The lock screw 1112 can be configured such that the actuating shaft 210 is not damaged when the lock screw 1112 contacts the actuating shaft 210. For example, in some embodiments, the lock screw 1112 can be provided with a non-abrasive tip configured to engage the actuating shaft 210 in a manner that does not result in damage to the actuating shaft 210.

[0165] Referring to FIG. 45, the second gear assembly 1104 may include an outer gear 1132 and a plurality of inner gears 1134 radially disposed within the outer gear 1132 and engaging with the outer gear 1132. The second gear assembly 1104 may be configured and function in the same manner as the second gear assembly 904 of the displacement control mechanism 900 and / or the gear assembly 706 of the displacement control mechanism 700. The outer gear 1132 of the second gear assembly 1104 has an axial length longer than the axial length of the inner gear 1134. Thereby, when the proximal end portion of the actuating shaft 210 is axially moved relative to the outer gear 1132, the inner gear 1134 can remain engaged with the outer gear 1132 (for example, due to different path lengths of the respective actuating shafts and / or for expanding / contracting the prosthetic valve). The inner gear 1134 is fixedly coupled to the respective actuating shaft 210 such that the inner gear 1134 and the actuating shaft 210 move together in both the axial and rotational directions.

[0166] By doing so, the gear assembly 1104 can be used to disengage / engage the actuating shaft 210 with the prosthetic valve. For example, by rotating the gears 1132, 1134 in a first direction (e.g., clockwise), the actuating shaft 210 is rotated in the first direction, and as a result, the threaded portion 242 on the distal end portion of the actuating shaft 210 can engage with the threaded portion of the rack member of the prosthetic valve (when the threaded portions on the distal end portion of the actuating 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 actuating shaft 210 is rotated in the second direction, and as a result, the threaded portion 242 on the distal end portion of the actuating shaft 210 can be disengaged from the threaded portion of the rack member of the prosthetic valve (when the threaded portions on the distal end portion of the actuating shaft and on the rack member are right-handed threads).

[0167] The displacement control mechanism 1100 can be used, for example, together with a delivery device 200 and an artificial valve 100. The artificial valve 100 is coupled to the distal end portion of the delivery device 200 and, in a radially compressed configuration (see, for example, FIGS. 13-15), 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 artificial valve 100 and the delivery device 200 are advanced through the patient's vasculature to an implantation position (e.g., the patient's native aortic valve). With the first gear assembly 1102 in an unlocked configuration, the proximal end portion of the actuating 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 accommodating various actuating shaft travel path lengths resulting from curvature in the shaft 206 of the delivery device 200 (such as when the shaft 206 is disposed in the patient's aortic arch).

[0168] When the artificial valve 100 is disposed at or near the implantation position, the first gear assembly 1102 of the displacement control mechanism 1100 can be moved from an unlocked configuration to a locked configuration by rotating the spur gear 1106, the flat gear 1108, and the lock screw 1112 about their respective axes relative to the carriage member 1110 as described above. With the first gear assembly 1102 in a 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 the actuating shaft 210 proximally relative to the shaft 206 of the delivery device 200. As a result, the artificial valve 100 is radially expanded. The artificial valve 100 can be recompressed by rotating the drive screw 1114 in an opposite second direction (e.g., for repositioning and / or retrieval). 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 actuating mechanism 220.

[0169] When the prosthetic valve 100 is positioned and expanded within the patient according to the user's desire, the prosthetic valve 100 can be locked in a 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. Thereby, the actuating shaft 210 can move freely relative to the carriage member 1110. Next, the outer gear 1132 of the second gear assembly 1104 is rotated about its axis relative to the handle 202, and as a result, the inner gear 1134 and the actuating shaft 210 are rotated together about their respective axes. As a result, the threaded portion 242 located at the distal end portion of the actuating shaft 210 retracts from the prosthetic valve 100 actuator 106. Thereby, the actuating shaft 210 is released from the prosthetic valve 100. The outer gear 1132 of the second gear assembly 1104 can be rotated relative to the handle 202 in various ways, including by a motor or knob of the release mechanism 222 and / or by directly rotating the outer gear 1132. Then, the delivery device 200 can be withdrawn from the patient's vasculature.

[0170] Figures 48 - 51 show a multi-lumen shaft 1200 according to one embodiment. This multi-lumen shaft 1200 (also referred to as "shaft 1200") can be used with the delivery device 200, for example, in place of the shaft 206. The shaft 1200 includes a plurality of helical actuation lumens 1202a, 1202b, and 1202c (collectively and / or generally referred to as "actuation lumens 1202") and a central lumen 1204 disposed radially inwardly from the actuation lumens 1202. The actuation lumens 1202 can be configured to receive respective actuating shafts 210a, 210b, and 210c (collectively and / or relatively referred to as "actuating shafts 210"). The central lumen 1204 can be configured to receive the nose cone shaft 214. Although not shown, the shaft 1200 can optionally include one or more other lumens, such as a recompression lumen.

[0171] Each actuation lumen 1202 extends in a helical path from the proximal end of the shaft 1200 to the distal end of the shaft 1200. The configuration of the shaft 1200 having the helical actuation lumen 1202 can be effective, for example, to ensure that each actuation shaft follows one similar axial path length even when the shaft 1200 is in a curved configuration (e.g., when the shaft 1200 is disposed within the aortic arch of a patient). This can be effective to reduce the elongation in these curved actuation shafts 210 and / or to ensure that the elongation in these curved actuation 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) of the shaft 1200 with respect to its first length portion, at a second circumferential position (e.g., an outer position) of the shaft 1200 with respect to its second length portion, at a third circumferential position (e.g., an inner position) of the shaft 1200 with respect to its third length portion, and at various circumferential positions between the first circumferential position, the second circumferential position, and the third circumferential position, so that these actuation shafts 210 move the same similar distance. Accordingly, the distance that each actuation shaft 210 moves through the shaft 1200 is the same (or at least substantially similar) to that of the other actuation shafts 210 whether the shaft 1200 is straight or curved. By doing so, the shaft 1200 can be effective, for example, to ensure that an artificial valve is uniformly expanded.

[0172] As used herein, the terms "neutral position" and "neutral location" refer to the circumferential position of the actuating shaft when the actuating shaft is radially aligned with the plane of symmetry of the curved shaft through which it extends. For example, when the shaft 1200 is curved to the left (Fig. 48) or right, the neutral position of the actuating shaft is when it is at the 0 / 360 degree (12 o'clock) position (see, for example, the position of the actuating shaft 210a in Fig. 49) and / or at the 180 degree (6 o'clock) position. As used herein, the term "offset position / location" refers to any circumferential position of the actuating shaft when the actuating shaft is radially offset from the plane of symmetry of the curved shaft through which it extends. In other words, the offset position is any non-neutral position. As used herein, the term "outer position / location" refers to any circumferential position of the actuating shaft when the actuating shaft is radially offset to the outside of the plane of symmetry of the curved shaft through which it extends. For example, when the shaft 1200 is curved to the left (Fig. 48), the outer position of the actuating shaft is when the actuating shaft is located at any position within the range of 1 to 179 degrees (the 90 degree position being the outermost position, see, for example, the position of the actuating shaft 210a in Fig. 50). As used herein, the term "inner position / location" refers to any circumferential position of the actuating shaft when the actuating shaft is radially offset to the inside of the plane of symmetry of the curved shaft through which it extends. For example, when the shaft 1200 is curved to the left (Fig. 48), the inner position of the actuating shaft is when the actuating shaft is located at any position within the range of 181 to 359 degrees (the 270 degree position being the innermost position, see, for example, the position of the actuating 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 rotations of each active lumen per unit length in the axial direction of the shaft), and various pitches can be used. By giving the active lumen 1202 a relatively high pitch, each active shaft 210 can be effective in ensuring that the same path length is followed even when the shaft 1200 is bent at an acute angle. Also, a high pitch can reduce the force required to move the active shaft axially (e.g., when expanding an artificial valve). Therefore, the pitch of the active lumen 1202 of the shaft 1200 can be selected to correspond to the degree to which the shaft 1200 is bent during the implantation procedure and to enable the active shaft to be moved axially to expand the artificial valve. For example, in some embodiments, the pitch of the active lumen can be less than 200 mm. In some embodiments, the pitch of the active lumen can be less than 140 mm. In some embodiments, the pitch of the active lumen can be between 140 mm and 70 mm. In certain embodiments, the pitch of the active lumen can be between 125 mm and 100 mm.

[0174] In the illustrated embodiment, the active lumens 1202 are uniformly distributed relative to each other in the circumferential direction of the shaft 1200. In other words, the angle between adjacent active lumens 1202 is approximately 120 degrees. In other embodiments, the active lumens 1202 can be non-uniformly distributed relative to each other.

[0175] In some embodiments, the delivery device can include a shaft and omit the force control mechanism and / or the displacement control mechanism. This is because the shaft 1200 is effective in ensuring that the shafts 1200 follow a similar distance even when bent. This can be effective in ensuring that the artificial valve expands uniformly, for example, when the active 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 mainly illustrated and described in connection with the prosthetic valve 100 and the delivery device 200, it should be noted that the force control mechanism, displacement control mechanism, and multi-lumen shaft disclosed herein can be used with a variety of other prosthetic valves and / or delivery devices.

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

[0179] Further embodiments of the technology of the present disclosure Considering the above-described implementations of the subject matter of the present disclosure, the present application discloses the following further embodiments. It should be noted that a single feature of one embodiment or a combination of two or more features of that embodiment can also be a further embodiment that is still within the scope of the present disclosure of the present application when combined with one or more features of one or more other embodiments, optionally.

Embodiment

[0180] A delivery device for implanting an artificial heart valve, the delivery device comprising a handle, a first shaft, a plurality of actuating 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 actuating shaft has a proximal end portion and a distal end portion, and these actuating shafts extend through one or more lumens of the first shaft. The control mechanism is coupled to the actuating 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 actuating shafts can move axially relative to each other and relative to the first shaft, and in the second operating mode, these actuating shafts can be moved axially simultaneously.

Example

[0181] A delivery device according to any embodiment of this chapter, particularly the delivery device of Example 1, wherein the control mechanism includes a force control mechanism.

Example

[0182] A delivery device according to any embodiment of this chapter, particularly the delivery device of Example 2, wherein the force control mechanism comprises a pulley, two proximal end portions of the actuating shafts are coupled together via this pulley, and when the tensions of these two actuating shafts are not equal, these two proximal end portions of the actuating shafts move axially relative to each other and the pulley rotates.

Example

[0183] In any embodiment of this chapter, particularly the delivery device of Embodiment 2, a plurality of operating shafts consist of a first operating shaft, a second operating shaft, and a third operating 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 operating shaft and the second operating shaft are coupled together via the first pulley. The third operating shaft extends around the second pulley and the third pulley. When the tension acting on the first operating shaft is different from the tension acting on the second operating shaft, the proximal end portions of the first operating shaft and the second operating shaft move axially relative to each other, the first pulley rotates. When the tension acting on the third operating shaft is different from the tension acting on the first operating shaft and the second operating shaft, the proximal end portion of the third operating shaft moves relative to the first operating shaft and the second operating shaft, and the second pulley and the third pulley rotate. Delivery device.

Embodiment

[0184] In any embodiment of this chapter, particularly the delivery device of any one of Embodiments 1 to 4, further comprising an operating mechanism coupled to one of the operating shafts and configured to axially move the plurality of aforementioned operating shafts simultaneously. Delivery device.

Embodiment

[0185] In any embodiment of this chapter, particularly the delivery device of Embodiment 5, the operating mechanism includes a rotary knob. When the rotary knob rotates, as a result, the plurality of aforementioned operating shafts are axially moved simultaneously. Delivery device.

Embodiment

[0186] In any embodiment of this chapter, particularly the delivery device of Embodiment 5, the operating mechanism includes an electric motor having a rotary shaft. When the rotary shaft rotates, as a result, the plurality of aforementioned operating shafts are axially moved simultaneously. Delivery device.

Example

[0187] A delivery device according to any example of this chapter, particularly any one of Examples 5 to 7, wherein the operating mechanism includes a spool configured to increase or decrease the tension acting on the operating shaft.

Example

[0188] A delivery device according to any example of this chapter, particularly any one of Examples 1 to 9, wherein the control mechanism includes a displacement control mechanism.

Example

[0189] A delivery device according to any example of this chapter, particularly the delivery device of Example 9, wherein the displacement control mechanism includes a gear assembly having an outer gear and a plurality of inner gears, the inner gears are respectively coupled to their respective operating shafts, and by rotating the outer gear with respect to the first shaft, as a result, the inner gears and the operating shafts are simultaneously rotated with respect to the first shaft.

Example

[0190] A delivery device according to any example of this chapter, particularly the delivery device of Example 9, wherein the displacement control mechanism includes a first gear assembly and a second gear assembly, by rotating the first gear assembly with respect to the first shaft, as a result, the plurality of aforementioned operating shafts are simultaneously axially moved with respect to the first shaft, and by rotating the second gear assembly with respect to the first shaft, as a result, the plurality of aforementioned operating shafts are simultaneously rotated with respect to the first shaft.

Example

[0191] A delivery device according to any example of this chapter, particularly the delivery device of Example 11, wherein the first gear assembly is coupled to the operating mechanism and the second gear assembly is coupled to the release mechanism.

Example

[0192] A delivery device according to any embodiment of this chapter, particularly any one of the delivery devices of Embodiments 11 to 12, comprising a sliding outer gear configured to be moved between a first position and a second position, wherein in the first position, the sliding outer gear engages a plurality of first inner gears of a first gear assembly, and in the second position, the sliding outer gear engages a plurality of second inner gears of a second gear assembly.

Example

[0193] A delivery device according to any embodiment of this chapter, particularly the delivery device of Embodiment 9, wherein the displacement control mechanism comprises a coupling member, an actuating member, and a gear assembly, the coupling member is coupled to the distal end portion of the actuating shaft, the actuating member extends through a first shaft, a first end portion of the actuating member is coupled to the coupling member, the gear assembly is coupled to the proximal end portion of the actuating shaft, by axially moving the actuating member relative to the first shaft, as a result, the coupling member and the actuating shaft are simultaneously axially moved relative to the first shaft and the gear assembly, and by rotating the gear assembly relative to the first shaft, as a result, the plurality of the foregoing actuating shafts are simultaneously rotated relative to the first shaft.

Example

[0194] A delivery device according to any embodiment of this chapter, particularly the delivery device of Embodiment 14, wherein the actuating member is coupled to an actuating mechanism.

Example

[0195] A delivery assembly comprising a delivery device according to any embodiment of this chapter, particularly any one of the delivery devices of Embodiments 1 to 15, and a mechanically expandable artificial heart valve.

Example

[0196] A delivery assembly according to any embodiment of this chapter, particularly the delivery assembly of embodiment 16, wherein the mechanically expandable artificial heart valve comprises a frame with a plurality of struts and a plurality of actuators, these struts of the frame being rotatably coupled together, the actuators being coupled to the struts of the frame and configured to move the frame between a radially compressed configuration and a radially expanded configuration.

Example

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

Example

[0198] A delivery device comprising a handle, a first shaft, a plurality of operating 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 operating shaft has a proximal end portion and a distal end portion, and the operating shaft extends through one or more lumens of the first shaft. The force control mechanism is coupled to the operating shaft and the handle. The force control mechanism is configured such that when the first shaft is curved, the proximal end portions of the operating shafts can move axially relative to each other.

Example

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

Example

[0200] A delivery device according to any embodiment of this chapter, particularly the delivery device of Embodiment 20, wherein the pulley system includes 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.

Embodiment

[0201] A delivery device comprising a handle, a first shaft, a plurality of actuating 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 actuating shaft has a proximal end portion and a distal end portion, and the actuating shaft extends through one or more lumens of the first shaft. The displacement control mechanism is coupled to the actuating shaft and the handle. The displacement control mechanism is configured such that when the first shaft is curved, the proximal end portions of the actuating shafts can move axially relative to each other.

Embodiment

[0202] A delivery device according to any embodiment of this chapter, particularly the delivery device of Embodiment 22, wherein the displacement control mechanism includes a gear assembly having an outer gear and a plurality of inner gears, the inner gears are fixedly coupled to their respective actuating shafts, and by rotating the outer gear relative to the first shaft, as a result, the inner gears and the actuating shafts are simultaneously rotated relative to the first shaft.

Embodiment

[0203] A delivery device according to any embodiment of this chapter, particularly the delivery device of Embodiment 23, wherein the outer gear has radially inwardly facing teeth having a first axial length, the inner gears have radially outwardly facing teeth having a second axial length, and the first axial length is greater than the second axial length such that when the actuating shafts move axially relative to each other, the teeth of the inner gears remain engaged with the teeth of the outer gear.

Embodiment

[0204] A delivery device according to any embodiment of this chapter, particularly the delivery device of 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] A delivery device according to any embodiment of this chapter, particularly the delivery device of 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] A delivery device according to any embodiment of this chapter, particularly the delivery device of 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] A delivery device according to any embodiment of this chapter, particularly the delivery device of 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 according to any embodiment of this chapter, particularly the delivery device of 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 engaging with the inner gear, the gear assembly being spaced from the handle and disposed within or adjacent to the distal end portion of the first shaft, and by rotating the peripheral gears relative to the first shaft, the peripheral gears are rotated relative to the first shaft and the peripheral gears are fixedly coupled to their respective operating shafts.

Example

[0209] A delivery device according to any embodiment of this chapter, particularly the delivery device of Embodiment 29, wherein the displacement control mechanism further includes a coupling member and an operating member, the peripheral gear is rotatably coupled to the coupling member, the first end portion of the operating member is coupled to the coupling member, the second end portion of the operating member is disposed within the handle, and when the operating member is axially moved relative to the first shaft, as a result, the coupling member and the operating shaft are simultaneously axially moved relative to the first shaft, and when the operating member is rotated relative to the first shaft, as a result, the inner gear, the peripheral gear, and the operating shaft are simultaneously rotated relative to the first shaft.

Embodiment

[0210] A delivery device according to any embodiment of this chapter, particularly the delivery device of Embodiment 30, wherein the operating member is coupled to the operating mechanism.

Embodiment

[0211] A delivery device including a handle, a first shaft, and a plurality of operating shafts. The first shaft has a first end portion, a second end portion, and a plurality of spiral lumens extending from the first end portion to the second end portion. The first end portion is coupled to the handle. Each operating shaft has a proximal end portion and a distal end portion, and the operating shaft extends through each respective spiral lumen of the first shaft.

Embodiment

[0212] A delivery device comprising a handle, a first shaft, a plurality of operating 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 operating shaft has a proximal end portion and a distal end portion, and the operating shafts extend through one or more lumens of the first shaft. The force control mechanism is coupled to the operating shafts and to the handle. The force control mechanism is configured such that when the first shaft is curved, the proximal end portions of the operating shafts can move axially relative to each other. The displacement control mechanism is coupled to the operating shafts and to the handle. The displacement control mechanism is configured such that when the first shaft is curved, the proximal end portions of the operating shafts can move axially relative to each other.

Example

[0213] A delivery device comprising a handle, a first shaft, a plurality of operating shafts, and a force control mechanism. The first shaft has a first end portion, a second end portion, and a plurality of helical lumens extending from the first end portion to the second end portion. The first end portion is coupled to the handle. Each operating shaft has a proximal end portion and a distal end portion, and the operating shafts extend through respective helical lumens of the first shaft. The force control mechanism is coupled to the operating shafts and is configured to uniformly disperse the force applied to the operating shafts.

Example

[0214] A delivery device comprising a handle, a first shaft, a plurality of operating shafts, and a displacement control mechanism. The first shaft has a first end portion, a second end portion, and a plurality of helical lumens extending from the first end portion to the second end portion. The first end portion is coupled to the handle. Each operating shaft has a proximal end portion and a distal end portion, and the operating shafts extend through respective helical lumens of the first shaft. The displacement control mechanism is coupled to the operating shafts and is configured such that when the first shaft is curved, the proximal end portions of the operating shafts can move axially relative to each other.

Embodiment

[0215] A delivery device comprising a handle, a first shaft, a plurality of operating shafts, a force control mechanism, and a displacement control mechanism. The first shaft has a first end portion, a second end portion, and a plurality of helical lumens extending from the first end portion to the second end portion. The first end portion is coupled to the handle. Each operating shaft has a proximal end portion and a distal end portion, and the operating shafts extend through respective helical lumens of the first shaft. The force control mechanism is coupled to the operating shafts and is configured to uniformly disperse the force applied to the operating shafts. The displacement control mechanism is coupled to the operating shafts and is configured such that when the first shaft is curved, the proximal end portions of the operating shafts can move axially relative to each other.

Embodiment

[0216] A force control mechanism for a delivery device for implanting an artificial heart valve is provided. The force control mechanism includes a pulley system and a movable carriage. The pulley system is configured to interconnect with a plurality of operating shafts of the delivery device. The movable carriage is coupled to the pulley system and is configured to be movably coupled to the handle of the delivery device. The pulley system and the movable carriage are configured to balance the force applied to the operating shafts of the delivery device and / or the force transmitted by the operating shafts of the delivery device by moving axially and / or rotationally.

Example

[0217] A force control mechanism for a delivery device for implanting an artificial heart valve is provided. This 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 operating shaft and a second operating shaft of the delivery device. The second pulley is configured to be coupled to a third operating shaft of the delivery device. The third pulley is configured to be coupled to the third operating 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. The proximal end portions of the first operating shaft and the second operating shaft move axially relative to each other, and the first pulley rotates when the tensions in the first operating shaft and the second operating shaft are not equal. When the tension in the third operating shaft is not equal to the tension in the first operating shaft or the second operating shaft, the proximal end portion of the third operating shaft moves axially relative to the first operating shaft and the second operating shaft, and the second pulley and the third pulley rotate.

Example

[0218] A displacement control mechanism for a delivery device configured for implanting an artificial heart valve is provided. This displacement control mechanism includes one or more gear assemblies. These gear assemblies are configured to be coupled to an operating shaft of the delivery device. The gear assemblies are configured such that the proximal end portions of the operating shaft can move axially independently of each other, and the operating shaft is configured to rotate simultaneously about their respective axes.

Example

[0219] A displacement control mechanism according to any embodiment of this chapter, particularly the displacement control mechanism of Embodiment 39, comprising a first gear assembly configured such that one or more gear assemblies are disposed within or near the distal end portion of the shaft of the delivery device.

Embodiment

[0220] A displacement control mechanism according to any embodiment of this chapter, particularly the displacement control mechanism of Embodiment 40, comprising a first gear assembly including an inner gear and a plurality of peripheral gears surrounding the inner gear.

Embodiment

[0221] A displacement control mechanism according to any embodiment of this chapter, particularly the displacement control mechanism of Embodiment 39, comprising a first gear assembly configured such that one or more gear assemblies are disposed within a handle located at the proximal end portion of the delivery device.

Embodiment

[0222] A displacement control mechanism according to any embodiment of this chapter, particularly the displacement control mechanism of Embodiment 42, comprising a first gear assembly including a plurality of inner gears and an outer gear surrounding these inner gears.

Embodiment

[0223] A displacement control mechanism according to any embodiment of this chapter, particularly the displacement control mechanism of any one of Embodiments 42 to 43, comprising a second gear assembly configured such that one or more gear assemblies are disposed within a handle located at the proximal end portion of the delivery device.

Embodiment

[0224] A displacement control mechanism according to any embodiment of this chapter, particularly the displacement control mechanism of Embodiment 44, comprising a second gear assembly including a plurality of inner gears and an outer gear surrounding these inner gears.

Embodiment

[0225] A displacement control mechanism according to any embodiment of this chapter, particularly the displacement control mechanism of Embodiment 42, wherein the first gear assembly includes a spur gear and a plurality of spur gears.

Embodiment

[0226] A shaft for a delivery device configured to implant an artificial heart valve is provided. The shaft includes a plurality of helical lumens extending from a first end portion of the shaft to a second end portion of the shaft, and each helical lumen is configured to receive an operating shaft of the delivery device.

Embodiment

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

Embodiment

[0228] A shaft according to any embodiment of this chapter, particularly the shaft of any one of Embodiments 47 to 48, comprising 3 to 15 helical lumens.

Embodiment

[0229] A shaft according to any embodiment of this chapter, particularly the shaft of any one of Embodiments 47 to 49, comprising 3 to 6 helical lumens.

Embodiment

[0230] A shaft according to any embodiment of this chapter, particularly the shaft of any one of Embodiments 47 to 50, comprising exactly three helical lumens.

[0231] Unless otherwise specified, features described in this specification in connection with any example can be combined with one or more other features described in any one or more of the other examples. For example, any one or more of the features of the force control mechanism 400 can be combined with any one or more of the features of the force control mechanism 606. As another example, any one or more of the features of the displacement control mechanism 700 can be combined with any one or more of the features of the displacement control mechanism 900.

[0232] Considering a number of possible embodiments to which the principles of the present disclosure can be applied, it should be understood that these exemplary embodiments are merely examples and should not be construed as limiting the scope of the claims. Furthermore, the scope of the claimed subject matter is defined by the appended claims and their equivalents.

Description of Reference Numerals

[0233] 10 Delivery assembly 100 Artificial heart valve 102 Frame 104 Valve structure 106 Actuator 108 First end 110 Second end 112 Strut 114 Pin 116 Valve tip 118 Crosslinking part 120 Rack member 122 Housing member 124 Lock member 126 Tooth 128 Tooth stop 130 Female threaded part 170 Stopper member 200 Delivery device 202 Handle 204 First shaft 206 Second shaft 208 Support sleeve 210 Actuating shaft 210a First actuating shaft 210b Second operating shaft 210c Third operating shaft 212 Recompression shaft 214 Nose cone shaft 216 Nose cone 218 First mechanism, deployment mechanism 220 Second mechanism, operating 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 lumen 240 Guide wire lumen 242 Male screw portion 244 Lumen 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 member 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 Track 500 Delivery device 502 Handle 504 Operating shaft 504a First operating shaft 504b Second operating shaft 504c Third operating shaft 504d Fourth operating 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 member 532 Anchor 600 Delivery device 602 Handle 604 Operating shaft 604a Operating shaft 604b Operating shaft 604c Operating shaft 604d Operating shaft 604e Operating 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 Coupling member 704 Actuating member 706 Gear assembly 708 Opening 710 Stopper member 712 Inner gear 714 Outer gear 716 Mounting portion 718 Tooth 720 Axial opening 721 Radial opening 722 Fixing element 724 Tooth 800 Displacement control mechanism 802 Coupling member 804 Actuating member 806 Gear assembly 808 Peripheral gear 810 Central gear 812 Fastener 900 Displacement control mechanism 902 First gear assembly 904 Second gear assembly 906 First outer gear 908 First inner gear 910 Insert 912 Bore with threaded portion 914 Opening 915 Slot 916 Second outer gear 917 Tab 918 Second inner gear 1000 Sliding outer gear 1100 Displacement control mechanism 1102 First gear assembly 1104 Second gear assembly 1106 Front gear 1108 Plain gear, first plain gear 1110 Carriage member 1112 Locking screw 1114 Drive screw 1116 Central opening 1118 Motor 1120 Central bore 1122 Main body 1124 Extension arm 1126 Connecting element 1128 Axial opening 1130 Radial opening 1132 Outer gear 1134 Inner gear 1200 Multi-lumen shaft, shaft 1202 Actuating lumen 1202a Spiral actuating lumen 1202b Spiral actuating lumen 1202c Spiral actuating lumen 1204 Central lumen

Claims

Claim 1 A delivery device for an artificial valve, comprising: a handle; 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, the first shaft; a plurality of actuating shafts each having a proximal end portion and a distal end portion, the actuating shafts extending through the one or more lumens of the first shaft; a control mechanism coupled to the actuating shafts and to the handle; In the delivery device, the control mechanism includes a force control mechanism; the plurality of actuating shafts include a first actuating shaft, a second actuating shaft, and a third actuating 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 actuating shaft and the second actuating shaft are commonly coupled via the first pulley; the third actuating shaft extends around the second pulley and the third pulley; 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; 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 and the third pulley rotate. A delivery device. Claim 2 The force control mechanism includes a pulley, and when the proximal end portions of two of the actuating shafts are commonly coupled via the pulley and the tensions acting on the two of the actuating shafts are not equal, the proximal end portions of the two of the actuating shafts move axially relative to each other and the pulley rotates. The delivery device according to claim 1. Claim 3 The delivery device according to claim 1 or 2, further comprising an operating mechanism coupled to one of the operating shafts of the operating shafts, the operating mechanism being configured to simultaneously move the operating shafts in the axial direction.

4. The operating mechanism includes a rotary knob, The delivery device according to claim 3, wherein the rotation of the rotary knob simultaneously moves the operating shaft in the axial direction.

5. The operating mechanism includes an electric motor having a rotary shaft, The delivery device according to claim 3, wherein the rotation of the rotary shaft simultaneously moves the operating shaft in the axial direction.

6. The delivery device according to any one of claims 3 to 5, wherein the operating mechanism includes a spool configured to increase or decrease the tension acting on the operating shaft.

7. The delivery device according to any one of claims 1 to 6, wherein the control mechanism includes a displacement control mechanism.

8. The displacement control mechanism includes a gear assembly having an outer gear and a plurality of inner gears, The inner gears are respectively coupled to the operating shafts, The delivery device according to claim 7, wherein by rotating the outer gear relative to the first shaft, the inner gears and the operating shafts are simultaneously rotated relative to the first shaft.

9. The displacement control mechanism includes a first gear assembly and a second gear assembly, By rotating the first gear assembly relative to the first shaft, the operating shaft is simultaneously axially moved relative to the first shaft, The delivery device according to claim 7, wherein by rotating the second gear assembly relative to the first shaft, the operating shaft is simultaneously rotated relative to the first shaft.

10. The first gear assembly is coupled to the operating mechanism, The delivery device according to claim 9, wherein the second gear assembly is coupled to the release mechanism.

11. The displacement control mechanism includes a sliding outer gear configured to move 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, The delivery device according to claim 9 or claim 10, wherein in the second position, the sliding outer gear engages a plurality of second inner gears of the second gear assembly.

12. 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 actuating shaft. The actuating member extends through the first shaft. A first end portion of the actuating member is coupled to the coupling member. The gear assembly is coupled to the proximal end portion of the actuating shaft. By axially moving the actuating member relative to the first shaft, the coupling member and the actuating shaft are simultaneously axially moved relative to the first shaft and the gear assembly. The delivery device according to claim 7, wherein by rotating the gear assembly relative to the first shaft, the actuating shaft is simultaneously rotated relative to the first shaft.

13. The delivery device according to claim 12, wherein the actuating member is coupled to an actuating mechanism.

14. A delivery assembly comprising the delivery device according to any one of claims 1 to 13, a mechanically expandable artificial heart valve.

15. The mechanically expandable artificial heart valve includes a frame having a plurality of struts and a plurality of actuators. The struts of the frame are rotatably coupled together. The delivery assembly according to claim 14, wherein the actuators are coupled to the struts of the frame and are configured to move the frame between a radially compressed configuration and a radially expanded configuration.

16. The actuating shaft of the delivery device is releasably coupled to the actuator of the artificial heart valve such that axial relative movement between the actuating shaft and the first shaft causes the frame of the artificial heart valve to move between the radially compressed configuration and the radially expanded configuration.

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