Expandable transition element for transcatheter delivery device

Abstract

To provide a delivery device reducing gap formation between a nose cone and an artificial valve of a delivery device.SOLUTION: A transcatheter delivery system including an expandable transition element is disclosed. An assembly may comprise a prosthetic valve and a delivery device. The delivery device may comprise an outer shaft with a distal end portion forming a sheath adapted to enclose the prosthetic valve therein in a radially compressed configuration; an inner shaft which is arranged within the outer shaft, includes a nose cone arranged at a distal end of the inner shaft, the nose cone being arranged outside the outer shaft at a distal end portion of the outer shaft; and an expandable transition element configured to expand from a non-expanded state within the outer shaft to an expanded state outside the outer shaft and in which in the expanded state, the transition element forms a continuous transition from the nose cone to the prosthetic valve when the sheath is moved to uncover the prosthetic valve.SELECTED DRAWING: Figure 5

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims the benefit of U.S. Provisional Application No. 62 / 928,973, filed Oct. 31, 2019, entitled “EXPANDABLE TRANSITION ELEMENT FOR A TRANSCATHETER DELIVERY DEVICE,” which is hereby incorporated by reference in its entirety.

[0002] The present disclosure relates to embodiments of an assembly and related methods for providing a more continuous transition between an artificial medical device and a nose cone of a delivery device configured to deliver the artificial medical device to a target implantation site via a transition element.

Background Art

[0003] The human heart can suffer from various valvular diseases. These valvular diseases can lead to significant heart dysfunction and ultimately may require repair of the native valve or replacement of the native valve with an artificial valve. There are known repair devices (e.g., stents) and artificial valves, as well as multiple known methods for implanting these devices and valves into humans. Percutaneous and minimally invasive surgical approaches are used in various procedures to deliver artificial medical devices to locations within the body that are not easily accessible surgically or where it is desirable to access without surgery. In a specific example, an artificial heart valve can be attached in a crimped state to the distal end of a delivery device (e.g., a delivery apparatus) proximate to the nose cone of the delivery device and advanced through the patient's vasculature (e.g., the femoral artery and aorta) until the artificial valve reaches the implantation site in the heart. The artificial valve is then expanded to its functional size, for example, by inflating a balloon to which the artificial valve is attached, actuating a mechanical actuator that applies an expanding force to the artificial valve, or deploying the artificial valve from the sheath of the delivery device such that the artificial valve can self - expand to its functional size.

[0004] Artificial valves that rely on mechanical actuators for expansion can be referred to as "mechanically expandable" artificial heart valves. The actuator typically takes the form of a pull cable, suture, wire, and / or shaft configured to transmit an expansion force from the handle of the delivery device to the artificial valve.

[0005] In some embodiments, after the artificial valve is deployed from the sheath of the delivery device but before it is actively expanded by the actuator of the delivery device, the artificial valve can assume a partially expanded (e.g., uncompressed) diameter that is larger than its fully compressed diameter (after crimping) and smaller than its fully expanded diameter (after being expanded by the actuator of the delivery device). As a result of this diameter expansion, a gap can be formed between the nose cone of the delivery device and the distal end of the artificial valve. This gap can create a discontinuity between the artificial valve and the nose cone and can make it difficult to reposition the artificial valve at the target implantation site. For example, in some embodiments, during repositioning of the artificial valve, the gap can cause the artificial valve to contact the patient's anatomical structure unnecessarily. Therefore, an improvement to the delivery device that reduces the formation of a gap between the nose cone of the delivery device and the artificial valve (in some examples, after deployment from the sheath of the delivery device) is desirable.

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

Patent Document 8

Patent Document 9

Patent Document 10

Patent Document 11

Patent Document 12

Patent Document 13

Patent Document 14

Patent Document 15

Summary of the Invention

Means for Solving the Problems

[0007] Disclosed herein are an assembly comprising an artificial valve and a delivery device, and related methods for delivering and implanting an artificial valve to a target implantation site using the delivery device. The delivery device (which may sometimes be referred to herein as a delivery device) can be used to deliver an implantable medical device such as an artificial heart valve to a target site in a patient, such as the heart. In some embodiments, the delivery device can be a component of a delivery system (e.g., an intravascular delivery system or a transcatheter delivery system) that can be used to deliver an artificial heart valve or other implantable medical device.

[0008] In some embodiments, the delivery device may be configured to have an expandable transition element disposed in a non-expanded (e.g., compressed) state within the outer shaft of the delivery device while delivering (e.g., manipulating) the delivery device to the target implantation site. The transition element may be configured to expand from a non-expanded state within the outer shaft to an expanded state outside the outer shaft. In the expanded state, the transition element moves the distal end of the outer shaft away from the nose cone and forms a continuous transition from the nose cone of the delivery device to the prosthetic valve when exposing the prosthetic valve. The expandable transition element may be any of an inflatable balloon, a pre-inflated balloon, a compressible element (e.g., sponge), and a mechanical element (having an expandable frame).

[0009] In a representative embodiment, the assembly includes a prosthetic valve and a delivery device. The delivery device has an outer shaft having a distal end portion forming a sheath configured to surround the prosthetic valve in a radially compressed configuration, and an inner shaft disposed within the outer shaft and having a nose cone disposed at the distal end of the inner shaft. The nose cone is disposed outside the outer shaft at the distal end portion of the outer shaft and includes an expandable transition element configured to expand from a non-expanded state within the outer shaft to an expanded state outside the outer shaft. In the expanded state, the transition element moves the sheath away from the nose cone and forms a continuous transition from the nose cone to the prosthetic valve when exposing the prosthetic valve.

[0010] In some embodiments, the delivery device further includes at least one actuator assembly disposed within the outer shaft and releasably coupled to the prosthetic valve.

[0011] In some embodiments, the transition element is a balloon.

[0012] In some embodiments, the balloon is an inflatable balloon that can expand from a contracted state before removing the artificial valve from the sheath to an expanded state after removing the artificial valve from the sheath. Further, in some embodiments, when the balloon is in the contracted state, the balloon is disposed within the sheath in a radially compressed configuration between the nose cone and the distal end of the artificial valve. In some embodiments, when the balloon is in the expanded state, the balloon is disposed outside the outer shaft between the nose cone and the distal end of the artificial valve.

[0013] In some embodiments, the balloon is a stretchable balloon formed from an elastic material and is configured to expand to a desired size within a range of possible sizes based on the size of the artificial valve.

[0014] In some embodiments, the balloon is a semi-stretchable balloon containing Pebax.

[0015] In some embodiments, the balloon is a non-stretchable balloon formed from a non-elastic material and is configured to expand to a predetermined size when fully inflated, and the predetermined size is selected based on the size of the artificial valve.

[0016] In some embodiments, the balloon is a pre-inflated balloon that passively transitions between a compressed state when disposed within the sheath and an expanded state when the sheath is moved away from the balloon, and is pre-inflated to the expanded state.

[0017] In some embodiments, the transition element is a compressible element including one or more of a compressible foam and a sponge. In some embodiments, the proximal end of the compressible element tapers inwardly toward the longitudinal central axis of the assembly.

[0018] In some embodiments, the transition element is an expandable mechanical element. In some embodiments, the mechanical element comprises an expandable frame with a plurality of arms, each arm of the plurality of arms having a distal end attached to a nose cone and a proximal end not attached to a delivery device and configured to expand from a compressed state to an expanded state. In some embodiments, the mechanical element further comprises a cover surrounding the plurality of arms around the periphery of the expandable frame. In some embodiments, the mechanical element further comprises a compression mechanism configured to recompress the frame from an expanded state to a compressed state.

[0019] In some embodiments, in the expanded state, the proximal end of the transition element contacts the distal end of the prosthetic valve and the distal end of the transition element contacts the proximal end of the nose cone.

[0020] In some embodiments, the distal end of the transition element is attached to the proximal end of the nose cone.

[0021] In another exemplary embodiment, the method comprises advancing a delivery device of a transcatheter delivery system to a target implantation site in a patient, the delivery device comprising an outer shaft having a distal end portion that forms a sheath surrounding a radially compressed prosthetic valve proximate to the proximal end of the nose cone of the delivery device, and after reaching the target implantation site, moving the distal end portion of the outer shaft axially away from the nose cone to expose the prosthetic valve, and expanding a transition element of the delivery device in a space formed between the proximal end of the nose cone and the distal end of the prosthetic valve.

[0022] In some embodiments, the prosthetic valve expands to a partially expanded state when the distal end portion of the outer shaft is moved away from the nose cone.

[0023] In some embodiments, the method can further comprise repositioning the partially expanded prosthetic valve to the target implantation site after expanding the transition element.

[0024] In some embodiments, after repositioning the prosthetic valve, the method can further include actively expanding the prosthetic valve radially to a radially expanded state.

[0025] In some embodiments, the step of actively expanding the prosthetic valve includes actively expanding the prosthetic valve via one or more actuator assemblies of the delivery device, and the one or more actuator assemblies extend from within the outer shaft and are coupled to the prosthetic valve.

[0026] In some embodiments, the transition element is an inflatable balloon, and the step of expanding the transition element includes expanding the inflatable balloon from a collapsed state to an inflated state.

[0027] In some embodiments, the inflatable balloon is a stretchable balloon formed from an elastic material, and the step of expanding the inflatable balloon from a collapsed state to an inflated state includes expanding the inflatable balloon to a desired size within a range of possible sizes based on the size of the prosthetic valve.

[0028] In some embodiments, the inflatable balloon is a semi-stretchable balloon comprising Pebax, and the step of expanding the inflatable balloon from a collapsed state to an inflated state includes expanding the inflatable balloon to a desired size within a range of possible sizes based on the size of the prosthetic valve.

[0029] In some embodiments, the inflatable balloon is a non-stretchable balloon formed from a non-elastic material, and the step of expanding the inflatable balloon from a collapsed state to an inflated state includes expanding the inflatable balloon to a predetermined size selected based on the size of the prosthetic valve.

[0030] In some embodiments, the distal end of the inflatable balloon is attached to the proximal end of the nose cone.

[0031] In some embodiments, the transition element is a pre - inflated balloon, and the step of expanding the transition element includes passively expanding the pre - inflated balloon from a radially compressed state to a radially expanded state, and the pre - inflated balloon assumes its pre - inflated size when in the radially expanded state.

[0032] In some embodiments, the transition element is a compressible element including one of a compressible form and a sponge material, and the step of expanding the transition element includes passively expanding the compressible element from a compressed state to an expanded non - compressed state, and the compressible element assumes its resting state when in the expanded state.

[0033] In some embodiments, the transition element is a mechanical element with an expandable frame having a distal end coupled to a nose cone, and the step of expanding the transition element includes expanding the proximal end of the expandable frame from a compressed state to an expanded state.

[0034] In another representative embodiment, the assembly can include a mechanically expandable prosthetic valve having a distal end and a proximal end, and a delivery device. The delivery device includes an outer shaft having a distal end portion forming a sheath configured to surround the prosthetic valve in a radially compressed configuration, at least one actuator assembly disposed within the outer shaft and releasably coupled to the prosthetic valve, and an inner shaft. The inner shaft is disposed within the outer shaft and includes a nose cone disposed at the distal end of the inner shaft. The nose cone is disposed adjacent to the distal end of the prosthetic valve outside the outer shaft. The assembly can include an expandable transition element configured to expand from a non - expanded state within the outer shaft to an expanded state outside the outer shaft. In the expanded state, the transition element forms a continuous transition from the proximal end of the nose cone to the distal end of the prosthetic valve when the sheath moves away from the nose cone and exposes the prosthetic valve.

[0035] In some embodiments, the distal end of the transition element is attached to the proximal end of the nose cone.

[0036] In some embodiments, the transition element is an inflatable balloon configured to inflate from a contracted state before removing the artificial valve from the sheath to an expanded state after removing the artificial valve from the sheath.

[0037] In some embodiments, the balloon is a stretchable balloon formed from an elastic material and is configured to inflate to a desired size within a range of possible sizes based on the size of the artificial valve.

[0038] In some embodiments, the balloon is a semi-stretchable balloon containing Pebax.

[0039] In some embodiments, the balloon is a non-stretchable balloon formed from a non-elastic material and is configured to expand to a predetermined size when fully inflated, and the predetermined size is selected based on the size of the artificial valve.

[0040] In some embodiments, the transition element is a pre-inflated balloon that passively transitions between a compressed state when disposed within the sheath and an expanded state when the sheath is moved away from the balloon, and is pre-inflated to the expanded state.

[0041] In some embodiments, the pre-inflated balloon is pre-filled with physiological saline.

[0042] In some embodiments, the pre-inflated balloon is pre-filled with hydrogel.

[0043] In some embodiments, the transition element is a compressible element that includes one or more of a compressible foam and a sponge.

[0044] In some embodiments, the transition element is an expandable mechanical element with an expandable frame having a plurality of arms, each arm of the plurality of arms having a distal end attached to the nose cone and a proximal end configured to expand from a compressed state when disposed within the sheath to an expanded state when the sheath is moved away from the mechanical element and not attached to the delivery device.

[0045] In some embodiments, in the expanded state, the transition element has a diameter that tapers from the distal end of the prosthetic valve to the proximal end of the nose cone.

[0046] In another representative embodiment, the assembly includes a prosthetic valve and a delivery device. The delivery device includes an outer shaft having a distal end portion that forms a sheath configured to surround the prosthetic valve in a radially compressed configuration, and an inner shaft disposed within the outer shaft and having a nose cone disposed at the distal end of the inner shaft, the nose cone being disposed outside the outer shaft, the outer shaft and the inner shaft being configured to move axially relative to each other to move the nose cone away from the distal end portion of the outer shaft to expose the prosthetic valve, and an expandable transition element disposed between the prosthetic valve and the nose cone and configured to expand from a non-expanded state within the outer shaft to an expanded state outside the outer shaft. The transition element is in a non-expanded state when the sheath covers the prosthetic valve and the transition element, and is in an expanded state when the sheath moves away from the nose cone to expose the prosthetic valve. In the expanded state, the transition element forms a continuous transition from the nose cone to the prosthetic valve.

[0047] In some embodiments, the distal end of the transition element is attached to the proximal end of the nose cone.

[0048] In some embodiments, the delivery device further includes at least one actuator assembly disposed within the outer shaft and releasably coupled to the prosthetic valve.

[0049] In some embodiments, at least one actuator assembly is configured to radially expand an artificial heart valve.

[0050] In some embodiments, the transition element is a balloon.

[0051] In some embodiments, the balloon is an inflatable balloon configured to receive inflation fluid and expand from a deflated state to an inflated state.

[0052] In some embodiments, when the balloon is in the deflated state, the balloon is disposed within the sheath in a radially compressed configuration between the nose cone and the distal end of the artificial valve.

[0053] In some embodiments, when the balloon is in the inflated state, the balloon is disposed outside the outer shaft between the nose cone and the distal end of the artificial valve.

[0054] In some embodiments, the balloon is a stretchable balloon formed from an elastic material and configured to inflate to a desired size within a range of possible sizes based on the size of the artificial valve.

[0055] In some embodiments, the balloon is a semi-stretchable balloon containing Pebax.

[0056] In some embodiments, the balloon is a non-stretchable balloon formed from a non-elastic material and configured to expand to a predetermined size when fully inflated, the predetermined size being selected based on the size of the artificial valve.

[0057] In some embodiments, the balloon is a pre-inflated balloon that passively transitions between a compressed state when disposed within the sheath and an expanded state when the sheath is moved away from the balloon, and is pre-inflated to the expanded state.

[0058] In some embodiments, the transition element is a compressible element that includes one or more of a compressible form and a sponge.

[0059] In some embodiments, the proximal end of the compressible element tapers inwardly toward the longitudinal central axis of the assembly.

[0060] In some embodiments, the transition element is an expandable mechanical element.

[0061] In some embodiments, the mechanical element includes an expandable frame with a plurality of arms, and each arm of the plurality of arms has a distal end attached to a nose cone and a proximal end that is not attached to the delivery device and is configured to expand from a compressed state to an expanded state.

[0062] In some embodiments, the mechanical element further includes a cover that surrounds the plurality of arms around the periphery of the expandable frame.

[0063] In some embodiments, the mechanical element further includes a compression mechanism configured to recompress the frame from an expanded state to a compressed state.

[0064] In some embodiments, in the expanded state, the proximal end of the transition element contacts the distal end of the artificial valve, and the distal end of the transition element contacts the proximal end of the nose cone.

[0065] The foregoing and other objects, features and advantages of the present invention will become more apparent from the following detailed description of the invention with reference to the accompanying drawings.

Brief Description of the Drawings

[0066]

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DETAILED DESCRIPTION OF THE INVENTION

[0067] Examples of a prosthetic valve, a delivery device (or device) configured to deliver the prosthetic valve to a target implantation location within the body, and a method of delivering and implanting the prosthetic valve to the target implantation site using the delivery device are described herein. The prosthetic valve (e.g., a prosthetic heart valve) can comprise a frame having a proximal end and a distal end. As used herein, the "distal end" of the frame can refer to the end of the frame that is disposed adjacent to and / or adjacent to the distal shoulder / nose cone of the delivery device when disposed within the outer shaft of the delivery device. For example, the distal end can be oriented downstream of the proximal end of the frame when the delivery device with the prosthetic valve disposed therein is advanced through the patient's lumen towards the target implantation site.

[0068] The delivery device may include an outer shaft having a distal end portion configured to form a sheath (or capsule) configured to surround the artificial valve in a radially compressed configuration while advancing the delivery device to the target implantation site. The delivery device may include an inner shaft, which is disposed within the outer shaft and includes a nose cone disposed at the distal end of the inner shaft, and the nose cone may further include an inner shaft disposed outside the outer shaft at the distal end portion of the outer shaft (while the outer shaft covers the artificial valve). In some embodiments, the delivery device may further include an expandable transition element configured to expand from a non-expanded state within the outer shaft to an expanded state outside the outer shaft. In the expanded state, the transition element may move such that the sheath moves away from the nose cone and may form a continuous transition from the nose cone to the artificial valve axially with respect to the longitudinal central axis of the delivery device when exposing the artificial valve. As a result, the artificial valve can be more easily repositioned via the delivery device at the target implantation site without causing an undesirable contact (which may in some cases cause damage to the anatomical structure or the valve) between the side of the patient's anatomical structure and the artificial valve.

[0069] The artificial valves disclosed herein can be radially compressible and expandable between a radially compressed configuration and a radially expanded configuration. Thus, the artificial valve can be crimped to an implant delivery device (e.g., a device) in a radially compressed configuration during delivery and then expanded to a radially expanded configuration when the artificial valve reaches the implantation site.

[0070] FIG. 1 shows an exemplary artificial valve 10 according to one embodiment. The artificial valve 10 can be radially compressible and expandable between a radially compressed configuration (see, e.g., FIG. 3) configured for delivery to a patient and a radially expanded configuration (see, e.g., FIGS. 1 and 4). In certain embodiments, the artificial valve 10 can be implanted within the native aortic valve annulus, but can also be implanted at other locations within the heart, including within the native mitral valve, native pulmonary valve, and native tricuspid valve. The artificial valve 10 can comprise an annular stent or frame 12 having a first end 14 and a second end 16.

[0071] In the depicted embodiment, the first end 14 is the inflow end and the second end 16 is the outflow end. The outflow end 16 can be coupled to a delivery device for delivering and implanting the artificial valve within the native aortic valve via a transfemoral retrograde delivery approach. Thus, in the delivery configuration of the artificial valve, the outflow end 16 is the most proximal end of the artificial valve. In other embodiments, the inflow end 14 can be coupled to the delivery device depending on the particular native valve being replaced and the delivery technique used (e.g., transseptal, transapical, etc.). For example, the inflow end 14 can be coupled to the delivery device when delivering the artificial valve to the native mitral valve via a transseptal delivery approach (thus being the most proximal end of the artificial valve in the delivery configuration).

[0072] The artificial valve 10 can also comprise a valve structure 18 coupled to the frame 12 and configured to regulate blood flow through the artificial valve 10 from the inflow end to the outflow end. The artificial valve 10 can further comprise a plurality of actuators 20 attached to the inner surface of the frame 12 and disposed equidistantly therearound. Each of the actuators 20 can be configured to make a releasable connection with one or more corresponding actuators of the delivery device, as further described below.

[0073] The valve structure 18 can include, for example, a leaflet assembly having one or more leaflets 22 (three leaflets 22 in the illustrated embodiment) made of a flexible material. The leaflets 22 of the leaflet assembly can be made entirely or partially of 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). The leaflets 22 can be arranged to form commissures 24, which can be attached to respective actuators 20, for example. Further details regarding transcatheter prosthetic heart valves, including aspects of coupling the valve structure to the frame 12 of the prosthetic valve 10, can be found in, for example, Patent Documents 1 to 6, all of which are hereby incorporated by reference in their entirety.

[0074] In some embodiments, the prosthetic valve 10 can include a plurality of commissure support elements configured as commissure retainers or clamps 26. In the illustrated configuration, the prosthetic valve includes commissure clamps 26 disposed at each commissure 24 at a radially inner spaced-apart position of the frame 12 and configured to grip adjacent portions of two leaflets 22 at each commissure 24. Each clamp 26 can be attached to an actuator 20 as shown. In alternative embodiments, the commissure support elements (such as clamp 26) can be attached to struts 28 of the frame, or alternatively, the commissures 24 can be attached directly (e.g., sutured) to struts of the frame. Further details of other techniques for attaching the commissure clamps 26 and the commissures of the valve assembly to the frame can be found in Patent Document 6.

[0075] Although not shown, the prosthetic valve 10 can also include one or more skirts or seal members. For example, the prosthetic valve 10 can include an inner skirt attached to the inner surface of the frame. The inner skirt can function as a seal member to prevent or reduce perivalvular leakage, to secure the valve leaflets 22 to the frame, and / or to protect the valve leaflets from damage caused by contact with the frame during crimping and during the operating cycle of the prosthetic valve. The prosthetic valve 10 can further include an outer skirt attached to the outer surface of the frame 12. The outer skirt can function as a seal member for the prosthetic valve by sealing against the tissue of the native annulus and assisting in reducing paravalvular leakage through 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.

[0076] The frame 12 can be made of any of a variety of suitable materials, such as stainless steel, cobalt-chromium alloy, or nickel-titanium alloy (“NiTi”), such as Nitinol. Referring again to FIG. 1, as shown, the frame 12 can include a plurality of interconnected struts 28 arranged in a lattice pattern. The struts 28 are shown as being arranged obliquely, or offset at an angle with respect to the longitudinal axis of the prosthetic valve 10, and radially offset from the longitudinal axis when the prosthetic valve 10 is in the expanded configuration. In other embodiments, the struts 28 can be offset by a different amount than depicted in FIG. 1, or some or all of the struts 28 can be arranged parallel to the longitudinal axis of the prosthetic valve 10.

[0077] In the illustrated embodiment, struts 28 are pivotally coupled to each other at one or more pivot joints along the length of each strut. For example, in the illustrated configuration, each of the struts 28 can be formed with openings (e.g., see opening 114 in FIG. 4) at both ends of the strut and openings spaced along the length of the strut. Each hinge can be formed at a position where the struts 28 overlap each other via a fastener or pivot member such as a rivet or pin 30 extending through the openings. The hinge can enable the struts 28 to pivot relative to each other when the frame 12 is radially expanded or compressed, such as during the assembly, preparation, or implantation of the prosthetic valve 10.

[0078] In some embodiments, the frame 12 can be constructed by forming individual components (e.g., the struts and fasteners of the frame) and then mechanically assembling and connecting the individual components together. In other embodiments, the struts 28 are not coupled to each other at each hinge but are pivotable or bendable relative to each other in another way to allow for radial expansion and contraction of the frame 12. For example, the frame 12 can be formed from a single piece of material (e.g., a metal tube) (e.g., via laser cutting, electroforming, or physical vapor deposition). Further details regarding the structure of the frame and prosthetic valve are described in Patent Documents 7-9, all of which are incorporated herein by reference. Additional examples of expandable prosthetic valves that can be used with the delivery device disclosed herein are described in Patent Documents 10 and 11, which are incorporated herein by reference.

[0079] Referring further to FIG. 1, in some embodiments, the prosthetic valve 10 can include one or more actuators 20 configured to cause radial expansion and compression of the frame. One or more actuators in the illustrated embodiment include one or more push-pull mechanisms 32 coupled to the frame 12. In the illustrated embodiment, the prosthetic valve 10 has three push-pull mechanisms 32, although in other embodiments, a greater or lesser number of push-pull mechanisms 32 can be used.

[0080] Each push-pull mechanism 32 can generally include an inner member 34, such as an inner tubular member, and an outer member 36 disposed around the inner member 34. The inner member 34 and the outer member 36 can be telescopically and longitudinally movable relative to each other to radially expand and contract the frame 12, as further described in Patent Documents 7, 12, and 13, which are incorporated herein by reference. The inner member 34 can be, for example, a rod, a cable, a wire, or a tube. The outer member 36 can be, for example, a tube or a sheath having sufficient rigidity to apply a distally directed force to the frame without buckling or buckling.

[0081] The inner member 34 can have a distal end portion 34a coupled to the inflow end 14 of the frame 12 (using a coupling element such as a pin member 30, for example). In the illustrated embodiment, each of the inner members 34 is coupled to the frame at respective tops 38 at the inflow end 14 of the frame 12. For example, the distal end portion 34a of each inner member 34 can be pivotally connected to a rivet or pin 30 that connects two struts at adjacent tops 38. The outer member 36 can be coupled to the top 38 of the outflow end 16 of the frame 12, if desired, for example, at an intermediate portion of the outer member 36 or at a proximal end portion of the outer member, as shown in FIG. 1. The outer member 36 can be pivotally connected to a rivet or pin 30 that connects two struts at adjacent tops 38.

[0082] The inner member 34 and the outer member 36 can be nested with respect to each other between a fully contracted state (corresponding to the fully radially expanded state of the artificial valve) and a fully extended state (corresponding to the fully radially compressed state of the artificial valve). In the fully extended state, the inner member 34 extends fully from the outer member 36. In this way, the push-pull mechanism 32 enables the artificial valve to be fully expanded or partially expanded to various diameters and holds the artificial valve in a partially or fully expanded state. As long as the inner and outer members of each actuator are coupled by pivot joints spaced apart in the axial direction of the frame, it should be understood that the inner member 34 and the outer member 36 can be coupled at other positions of the frame to cause radial compression and expansion of the frame.

[0083] In use, as further described below, a delivery device, such as the exemplary delivery device (e.g., device) 300 shown in FIG. 5, can be releasably coupled to the push-pull mechanism 32 of the artificial valve 10. For example, the delivery device can have one or more actuator assemblies releasably coupled to the respective push-pull mechanisms 32 of the artificial valve. The actuator (e.g., actuator assembly) of the delivery device can be configured to transmit a pushing force and / or a pulling force from the handle of the delivery device to the push-pull mechanism 32 of the artificial valve. Each of the actuator assemblies of the delivery device can include an inner member 42 releasably coupled to the respective inner member 34 of the push-pull mechanism 32. Each actuator assembly of the delivery device can further include an outer member (not shown) releasably coupled to the respective outer member 36 of the push-pull mechanism 32.

[0084] Once coupled to the delivery device, the prosthetic valve 10 can then be radially collapsed (see, e.g., FIG. 3), and the distal end portion of the delivery device can be inserted into the patient together with the radially collapsed valve. When the prosthetic valve 10 is at the desired implantation site, the prosthetic valve can be radially expanded (see, e.g., FIG. 4). In some embodiments, as shown in FIG. 1, the push-pull mechanism 32 can include one or more locking mechanisms 40 to enable the frame 12 to maintain the expanded diameter after the prosthetic valve is released from the delivery device. Further details of the locking mechanism can be found in Patent Document 6.

[0085] FIG. 2 shows a medical assembly according to another embodiment. The assembly includes a prosthetic valve 100 and one or more linear actuator assemblies 200 (one is shown in FIG. 2) releasably coupled to the prosthetic valve. The prosthetic valve 100 includes a frame 102. The prosthetic valve 100 can include the valve structure (e.g., having valve leaflets) 18 described above and inner and / or outer skirts, but these components are omitted for illustration purposes. The frame 102 includes a plurality of struts 116 in which an opening 114 (see FIG. 4) is formed, and pivot members 118 (e.g., pins or rivets) connecting the struts to each other form a plurality of pivot joints. The frame 102 can have the same structure as the frame 12, except that the frame 102 includes struts 116 that are longer than the struts 28 of the frame 12. The longer struts 116 form more pivot joints along the length of each strut, forming more openings or cells in the frame compared to the struts 28.

[0086] Figures 3-4 show the bare frame 102 (without valve tips and other components) of the prosthetic valve 100 to show the expansion of the prosthetic valve from a radially compressed configuration to a radially expanded configuration. FIG. 3 shows the frame 102 in a radially compressed configuration (having a diameter D), and FIG. 4 shows the frame 102 in a fully radially expanded configuration (having a diameter d). The prosthetic valve 100 of the illustrated configuration can be expanded radially by maintaining the first end 104 of the frame 102 in a fixed position while applying an axial force to the second end 106 toward the first end 104. Alternatively, the prosthetic valve 100 can be expanded by applying an axial force to the first end 104 while maintaining the second end 106 in a fixed position, or by applying opposite axial forces to each of the first end 104 and the second end 106.

[0087] One or more actuator assemblies 200 can be components of a delivery device (e.g., delivery device 300 of FIG. 5) and are configured to cause a radial expansion and compression of the frame 102. FIG. 2 shows a linear actuator assembly 200 that is in the process of separating from the frame 102 after the frame has been radially expanded. As shown, the actuator assembly 200 can include an inner actuator member 202 (which can also be referred to as an actuating member), a cover tube 204 that extends coaxially over the actuator member, a support tube or pusher member 206 that extends coaxially over the cover tube 204, and a threaded screw 208. The actuator member 202 can be, for example, a rod, a cable, or a wire. The actuator member 202 is connected to the threaded screw 208 at its distal end such that rotation of the actuator member causes rotation of the threaded screw 208. The proximal end of the actuator member 202 can be connected to a handle or other control device (not shown) of the delivery device that a physician or operator of the delivery device can use to rotate the actuator member 202. Similarly, the proximal ends of each cover tube 204 and each support tube 206 can be connected to the handle. For each actuator assembly 200, a pair of threaded nuts or sleeves 110 and stoppers 112 can be attached to the frame at axially spaced positions, for example, at or adjacent to the distal and proximal ends of the frame.

[0088] The screw 208 has an external threaded surface that can engage an internal threaded surface of a sleeve 110 attached to the frame 102, such as at the distal end of the frame. When the actuator member 202 rotates to screw the screw 208 into the sleeve 110, the actuator member 202 is connected to the distal end of the frame 102 such that proximal or distal movement of the actuator member 202 causes proximal or distal movement of the distal end of the frame 102, respectively.

[0089] The cover tube 204 annularly surrounds the actuator member 202. The cover tube 204 can be connected to the actuator member 202 such that the actuator member 202 and the cover tube 204 rotate together and move axially together. The actuator member 202 and the cover tube 204 extend through a stopper 112 that can be attached to the proximal end of the frame. The support tube 206 annularly surrounds the cover tube 204. The stopper 112 has an annular inner surface with an inner diameter larger than the outer diameters of the cover tube 204 and the screw 208 such that when the frame 102 is expanded and the actuator is retracted proximally by the user separating the actuator from the frame, the cover tube 204 and the screw 208 can be retracted through the stopper 112. The stopper 112 is sized to abut or engage the distal end of the support tube 206 so as to prevent the support tube 206 from moving distally beyond the stopper 112.

[0090] During operation, prior to implantation in a patient, the screw 208 is threaded into the sleeve 110, thereby connecting the linear actuator assembly 200 to the frame 102. The frame 102 can then be placed in a radially collapsed state and the distal end portion of the artificial valve and the delivery device can be inserted into the patient. Once the artificial valve 100 is positioned at the desired implantation site, the frame 102 can be radially expanded as described herein.

[0091] To radially expand the frame 102, the support tube 206 contacts the stopper 112 and is firmly held. Next, the actuator member 202 is pulled proximally through the support tube 206, for example, by pulling the proximal end of the actuator member 202 or by operating the control knob of the handle to move the actuator member 202 in the proximal direction. Since the support tube 206 is held in contact with the stopper 112 connected to the proximal end of the frame 102, the proximal end of the frame 102 is prevented from moving relative to the support tube 206 and the handle. Therefore, as a result of moving the actuator member 202 in the proximal direction, the distal end of the frame 102 is moved in the proximal direction, causing the frame 102 to contract axially and expand radially.

[0092] It should be understood that the frame 102 can also be radially expanded by pressing the support tube 206 against the stopper 112 while keeping the actuator member 202 stationary relative to the handle, or alternatively, by pushing the support tube 206 distally relative to the stopper 112 and simultaneously pulling the actuator member 202 proximally, thereby pushing the proximal end of the frame towards the distal end of the frame.

[0093] After the frame 102 has been expanded to a desired radially expanded size, one or more locking mechanisms can be actuated to lock the frame 102 at the desired radially expanded size, and the linear actuator assembly 200 can be separated from the frame 102. To separate the linear actuator assembly 200 from the frame 102, the actuator member 202 can be rotated to remove the screw 208 from the stopper 112. Then, the actuator member 202 and the cover tube 204 can be retracted proximally through the stopper 112, and the linear actuator assembly 200 (including the actuator member 202, the screw 208, the cover tube 204, and the support tube 206) can be withdrawn from the patient. The cover tube 204 facilitates the passage of the screw 208 through the stopper 112. In some embodiments, the cover tube 204 may be omitted. In embodiments having a plurality of linear actuator assemblies 200, the above-described procedure for expanding the frame 102 is performed for each linear actuator assembly 200

[0094] Further details of the actuator assembly and various exemplary locking mechanisms can be found in Patent Document 15.

[0095] FIG. 5 shows a delivery device 300 (also referred to herein as a delivery device) according to one embodiment configured to deliver an artificial heart valve 308 (e.g., an artificial valve), such as the artificial heart valve 100 shown in FIGS. 2-4 and / or the artificial valve 10 shown in FIG. 1, as described above. The artificial valve 308 can be releasably coupled to the delivery device 300, as further described below. It should be understood that the delivery device 300 and other delivery devices disclosed herein can be used to implant artificial devices other than artificial valves, such as stents or grafts.

[0096] The delivery device 300 of the illustrated embodiment generally includes a handle 302, an elongated shaft 304 extending distally from the handle 302 (which constitutes the outer or outermost shaft in the illustrated embodiment), an inner (e.g., innermost) shaft 310, and at least one actuator assembly (e.g., member or actuator) 306 for expanding and compressing an artificial valve that extends distally outward from the distal end portion 312 of the outer shaft 304 through the outer shaft 304.

[0097] The inner shaft 310 can define a lumen configured to receive a guidewire. For example, while delivering a medical device (e.g., an artificial heart valve) implantable using the delivery device 300 to a target implantation site, the delivery device 300 can be advanced along a guidewire to the target implantation site.

[0098] The delivery device 300 can include three actuator assemblies 306 (only two of the three are shown in FIG. 5) releasably coupled to the artificial valve. However, in alternative embodiments, the delivery device 300 can include more or fewer than three actuator assemblies 306 (e.g., one, two, four, etc.). As shown in FIG. 5, the plurality of actuator assemblies 306 can be circumferentially spaced from each other around the delivery device 300 and can extend axially through the outer shaft 304 from the handle 302 to the artificial valve 308.

[0099] In certain embodiments, each actuator assembly 306 can be releasably coupled to a corresponding actuator of the prosthetic valve (e.g., the push-pull mechanism 32 shown in FIG. 1). Each actuator assembly 306 can include an inner member having a distal end releasably coupled to an inner member 34 of the push-pull mechanism 32 (similar to inner member 42 shown in FIG. 1), and an outer member having a distal end releasably coupled to an outer member 36 of the push-pull mechanism 32. In another embodiment, each actuator assembly 306 can be an actuator assembly 200 releasably coupled to the prosthetic valve via a threaded sleeve 110.

[0100] As shown in FIG. 5, the distal end of the inner shaft 310 can include a nose cone 314 that can be used to guide the delivery device 300 through the patient's lumen to the target implantation site of the prosthetic valve 308. The nose cone 314 may be disposed proximate the distal end of the prosthetic valve 308.

[0101] In use, the delivery device 300 can be releasably coupled to the prosthetic valve 308 to effect radial expansion and compression of the frame of the prosthetic valve 308. In some embodiments, the actuator assembly 306 of the delivery device 300 can be configured to transmit a pushing force and / or a pulling force from the handle 302 of the delivery device 300 to the prosthetic valve 308. For example, in some embodiments, the actuator assembly 306 can have a distal end portion that can be releasably connected to the prosthetic valve 308 via respective release and lock units.

[0102] In some embodiments, the outer shaft 304 of the delivery device 300 can be configured as an operable guide catheter having an adjustable curvature for use when manipulating the delivery device 300 through the patient's vasculature. In certain embodiments, the outer shaft 304 can include an operable distal section, the curvature of which can be adjusted by the operator to assist in guiding the device through the patient's vasculature.

[0103] The outer shaft 304 and the actuator assembly 306 can be moved relative to each other (in the axial and / or rotational directions) to facilitate the delivery and positioning of the prosthetic valve 308 at the implantation site within the patient's body.

[0104] In some embodiments, the distal end portion 312 of the outer shaft 304 is formed and / or functions as a sheath (e.g., a capsule) sized and shaped to receive and accommodate the prosthetic valve 308 in a radially compressed state for delivery through the patient's vasculature. As the prosthetic valve 308 is advanced to or adjacent to the implantation site, the prosthetic valve 308 can be advanced from the sheath by advancing the actuator assembly 306 relative to the outer shaft 304, and then the prosthetic valve 308 can be radially expanded. In alternative embodiments, the outer shaft 304 can be configured to move axially relative to the actuator assembly 306 and the prosthetic valve.

[0105] Advancement of the prosthetic valve 308 from the sheath by axially moving the actuator assembly 306 relative to the outer shaft 304, or by retracting the outer shaft 304 relative to the actuator assembly 306, can be actuated by operating the first knob 316 of the handle 302. The first knob 316 can be operably connected to the proximal end portion of the outer shaft 304 and can be configured to retract the outer shaft 304 proximally relative to the actuator assembly 306 to deploy the prosthetic valve 308 from the distal end portion 312 of the sheath, or the first knob 316 can be operably connected to the proximal end of the actuator assembly 306 to advance the actuator assembly 306 distally relative to the outer shaft 304 to deploy the prosthetic valve 308 from the distal end portion 312 of the sheath. The first knob 316 can be a slidable or rotatable adjustment element operably connected to the actuator assembly 306 and / or the outer shaft 304.

[0106] As shown in FIG. 5, the handle 302 may include additional adjustment knobs such as a second knob 318 and a third knob 320. In some embodiments, the second knob 318 is operably coupled to the actuator assembly 306 and operates the actuator assembly 306 to adjust the prosthetic valve 308 from a non-expanded (or radially compressed) configuration (shown in FIG. 6B below) to a radially expanded configuration (shown in FIG. 6C below), and vice versa.

[0107] In some embodiments, the third knob 320 is operably coupled to the actuator assembly 306 and operates the actuator assembly 306 to be separable from the prosthetic valve 308. As a result, the prosthetic valve 308 can be detached from the delivery device 300 and implanted (e.g., placed) at the target implantation site.

[0108] Referring now to FIGS. 6A - 6C, portions of the delivery device 300 are shown at various stages of the prosthetic valve placement (e.g., implantation) procedure. As described above with reference to FIG. 5, the delivery device 300 includes an outer shaft 304 having a distal end portion 312 that forms a sheath (e.g., capsule) 322 configured to receive the crimped (radially compressed) prosthetic valve 308 while delivering the prosthetic valve 308 to the target implantation site. The delivery device 300 further includes an inner shaft 310 having a nose cone 314 attached to the distal end of the inner shaft 310. The inner shaft 310 extends through the interior of the outer shaft 304.

[0109] In some embodiments, as shown in FIGS. 6A-6C, the delivery device 300 can further include an intermediate shaft 324 that is coaxial with the outer shaft 304 and the inner shaft 310 (in the radial direction with respect to the longitudinal central axis of the delivery device) and is disposed therebetween. The intermediate shaft 324 may be configured to house and organize the actuator assembly 306. For example, the actuator assembly 306 may be housed within the distal end of the intermediate shaft 324 and may extend outwardly from the distal end of the intermediate shaft 324. In some embodiments, each actuator assembly 306 may remain separated from other actuator assemblies 306 within the intermediate shaft 324. For example, each actuator assembly 306 can extend through a separate lumen of the intermediate shaft 324.

[0110] Although FIGS. 6A-6C show only two actuator assemblies 306, the delivery device 300 can include three actuator assemblies 306 disposed around the perimeter of the frame of the prosthetic valve 308.

[0111] FIG. 6A shows the prosthetic valve 308 held in a radially compressed state within the sheath 322 of the delivery device 300. Thus, in FIG. 6A, the prosthetic valve 308 is in its radially compressed configuration having a minimum diameter D1. The minimum diameter D1 may be approximately the same as the inner diameter of the sheath 322. As shown in FIG. 6A, the sheath 322 surrounding the outside of the prosthetic valve 308 can maintain the prosthetic valve in a radially compressed configuration. As a result, the prosthetic valve 308 can be advanced through the patient's vasculature, for example, to a target implantation site via the delivery device 300.

[0112] As shown in FIG. 6A, the distal end 326 of the prosthetic valve 308 is disposed adjacent to the proximal end of the nose cone 314. Thus, there may be little to no gap between the nose cone 314 and the distal end 326 of the prosthetic valve 308.

[0113] After reaching the target implantation site, the sheath 322 can be pulled proximally along the longitudinal central axis of the delivery device 300 away from the nose cone 314 and the prosthetic valve 308 to expose the prosthetic valve 308. In an alternative embodiment, the actuator assembly 306 can be advanced distally to move the prosthetic valve 308 out of the sheath 322. FIG. 6B shows the prosthetic valve 308 in this exposed (e.g., released) state, disposed outside the sheath 322. In this state, the prosthetic valve 308 is not actively expanded via the actuator assembly 306. However, since the prosthetic valve 308 is no longer constrained (e.g., held within) by the sheath 322, the prosthetic valve 308 can assume a partially expanded diameter D2 that is larger than the minimum diameter D1 due to the inherent elasticity of the struts of the frame. For example, after being deployed from the sheath 322, the prosthetic valve 308 can expand radially by 10% - 20% with respect to the longitudinal central axis of the valve and the delivery device 300. It should be noted that the degree of expansion of the prosthetic valve 308 from the compressed minimum diameter D1 (FIG. 6A) to the partially expanded diameter D2 (FIG. 6B) may be exaggerated in FIG. 6B for illustrative purposes. The expansion of the diameter of the prosthetic valve 308 from the minimum diameter D1 to the partially expanded diameter D2 may form a gap having a length L2 between the distal end 326 of the prosthetic valve 308 and the proximal end of the nose cone 314.

[0114] FIG. 6C shows the prosthetic valve 308 after being actively expanded via the actuation of the actuator assembly 306. For example, from FIG. 6B to FIG. 6C, the user can actuate the actuator assembly 306 (e.g., via the second knob 318 of the handle 302 shown in FIG. 5) to expand the prosthetic valve 308 radially. As a result, the prosthetic valve 308 can be expanded radially to the expanded diameter D3 as shown in FIG. 6C. The expanded diameter D3 is larger than the partially expanded diameter D2. As a result of the larger expanded diameter D3, the gap between the nose cone 314 and the distal end 326 of the prosthetic valve 308 can increase to a length L3.

[0115] As shown in the embodiment of FIG. 6B, in a partially expanded state, the gap formed between the distal end of the valve and the nose cone may cause discontinuity. If repositioning of the prosthetic valve at the target implantation site is required at this stage, this discontinuity makes it difficult to advance the prosthetic valve distally, especially when the user attempts to pass through the native aortic valve annulus again. Further, in some embodiments, it may be necessary to reposition the prosthetic valve even after the prosthetic valve has been partially or fully expanded. Repositioning or re-passing of the prosthetic valve may require at least partial compression of the valve, subsequent repositioning (e.g., distally or proximally), and re-expansion at the new position. The gap between the nose cone and the distal end of the prosthetic valve can make valve repositioning difficult. For example, due to the formed gap, it may be difficult to reposition the valve distally and / or proximally without the valve contacting the patient's anatomical structure.

[0116] In some cases, the actuator assembly 306 may be configured to prevent any expansion of the prosthetic valve 308 after the prosthetic valve 308 has been advanced from the sheath 322 but before actively expanding the prosthetic valve using the actuator assembly. In other words, the prosthetic valve 308 can have a diameter equal to D1 after being advanced from the sheath 322. If there is a gap between the prosthetic valve 308 and the nose cone 314 when the prosthetic valve is held in the sheath 322, that gap typically remains even after the prosthetic valve has been advanced from the sheath 322. In such cases, the gap can make re-passing the native valve leaflets difficult.

[0117] In some embodiments, a gap may form between the nose cone and the distal end of a non-mechanical prosthetic valve (e.g., a balloon-expandable or self-expandable prosthetic valve) after expansion. In some cases, it may be necessary to reposition these types of valves after expansion. However, as described above, this gap can make repositioning of these types of prosthetic valves difficult.

[0118] Accordingly, it may be desirable to reduce the gap formed between a fully compressed artificial valve or a partially or fully expanded artificial valve and the nose cone of the delivery device, such that the valve can be more easily repositioned without damaging the patient's anatomical structure. As an example, even after partial or full expansion of the artificial valve, by forming a continuity (e.g., a continuous transition) between the nose cone and the distal end of the artificial valve, this gap can be reduced (or in some cases eliminated), thereby enabling the artificial valve to be more easily repositioned at the target implantation site.

[0119] For example, in some embodiments, a delivery device (e.g., an apparatus) configured to deliver an artificial medical device, such as an artificial heart valve, to a target implantation site can include a transition element configured to be disposed between the nose cone of the delivery device and the artificial medical device after being deployed from within the sheath of the outer shaft of the delivery device. In some embodiments, as shown in FIGS. 7A - 7D, the transition element can be a balloon. In some such embodiments, the balloon is deflated and disposed within the outer shaft during the device delivery process and is actively inflated between the distal end of the device and the proximal end of the nose cone after the device has been deployed from the sheath (if re - passage or repositioning is required; otherwise, there is no need to inflate the balloon), and can be an inflatable balloon. In other such embodiments, the balloon can be pre - filled (e.g., pre - inflated) within the outer shaft (or within another tube or shaft of the delivery device) during the delivery process, compressed, and then passively expanded between the nose cone and the device after the device has been deployed from the sheath.

[0120] In other embodiments, as shown in FIGS. 8A-8C, the transition element may be a compressible element such as a sponge. In still other embodiments, as shown in FIGS. 9A-9C, the transition element may be a mechanical element with an expandable frame. In this way, after being deployed from the sheath, the transition element may form a continuous transition between the nose cone and the artificial medical device.

[0121] FIGS. 7A-9C show embodiments of a delivery device (e.g., apparatus) 400 comprising a transition element 402 configured to be disposed between a nose cone 414 of the delivery device 400 and a partially expanded artificial valve (e.g., artificial heart valve) 408 after deployment from a sheath 422 of the delivery device 400. These embodiments can also be used when there is a gap between the fully compressed artificial valve and the nose cone 414 after deployment from the sheath (i.e., when the artificial valve has a diameter D1 after deployment from the sheath). Similar to the delivery device 300 described above with reference to FIGS. 5 and 6A-6C, the delivery device 400 includes an outer shaft 404 that can extend distally from a handle (not shown in FIGS. 7A-9C) of the delivery device 400. The outer shaft 404 has a distal end portion 412 that forms a sheath (e.g., capsule) 422 configured to receive the artificial valve 408 in a radially compressed (e.g., crimped) configuration during delivery of the artificial valve 408 to a target implantation site.

[0122] The delivery device 400 further includes an inner shaft 410 having a nose cone 414 attached to the distal end of the inner shaft 410. The inner shaft 410 extends through the interior of the outer shaft 404.

[0123] In some embodiments, the delivery device 400 can further include an intermediate shaft 424 that is coaxial with the outer shaft 404 and the inner shaft 410 and is disposed therebetween. The intermediate shaft 424 may be configured to house and organize one or more actuator assemblies (e.g., actuators) 406. For example, the actuator assembly 406 may be housed within the distal end of the intermediate shaft 424 and may extend outwardly from the distal end of the intermediate shaft 424.

[0124] The prosthetic valve 408 includes a frame having a proximal end 416 and a distal end 426, and the distal end 426 is disposed on the opposite side of the proximal end 416 in the direction of the longitudinal central axis 418 of the delivery device 400 (and the valve). The actuator assembly 406 may be coupled to the proximal end 416 of the frame of the prosthetic valve 408. The distal end 426 of the frame of the prosthetic valve 408 is disposed in proximity to the proximal end 420 of the nose cone (e.g., the proximal end 420 is disposed closer to the distal end 426 than the proximal end 416 of the frame of the prosthetic valve 408).

[0125] The prosthetic valve 408 shown in FIGS. 7A-9C is a mechanically expandable valve, but in alternative embodiments, the prosthetic valve 408 may be a balloon-expandable valve or a self-expandable valve. Thus, the delivery device 400 may not include the actuator assembly 406, and instead, if the prosthetic valve is fully self-expandable, it may not include an inflatable balloon, sheath, or additional components for expanding the prosthetic valve 408.

[0126] In some embodiments, as shown in FIGS. 7A-7D, the transition element 402 is the balloon 436. As shown in FIG. 7A, the prosthetic valve 408 is held in a radially compressed (e.g., crimped) state within the sheath 422 of the outer shaft 404. The balloon 436 is also disposed within the outer shaft 404. In some embodiments, as shown in FIG. 7A, the balloon 436 may be disposed within the sheath 422 between the distal end 426 of the prosthetic valve 408 and the proximal end 420 of the nose cone 414 (in the axial direction with respect to the longitudinal central axis 418). In alternative embodiments, the balloon 436 may be disposed within the outer shaft 404 at an alternative location (e.g., proximal to the prosthetic valve 408). In these embodiments, the prosthetic valve 408 may be disposed adjacent to the nose cone 414, and after the sheath 422 is retracted, the balloon 436 may be advanced proximally through the interior of the now uncompressed prosthetic valve 408 into the gap formed between the prosthetic valve 408 and the nose cone 414.

[0127] In some embodiments, the balloon 436 is an inflatable balloon configured to inflate from a deflated state (the state shown in FIG. 7A) to an inflated state (the state shown in FIG. 7B, further described below). For example, the balloon 436 may be held in a deflated (e.g., non-inflated) state within the sheath 422 when the prosthetic valve 408 is also held within the sheath 422 (in a radially compressed state), as shown in FIG. 7A. After the prosthetic valve 408 is deployed from the sheath 422 and exposed (e.g., not surrounded by the sheath 422) (e.g., via axially retracting the outer shaft 404 proximally and / or advancing the valve 408 axially distally from the outer shaft 404), the prosthetic valve 408 can assume a partially expanded state (e.g., not actively expanded by an actuator assembly) having a partially expanded diameter that is larger than the radially compressed diameter when disposed within the sheath 422 (as described above with reference to FIG. 6B). The balloon 436 may then be actively inflated via an inflation device, as shown in FIG. 7B.

[0128] In one embodiment, a balloon catheter may be used to inflate and deflate balloon 436. For example, the balloon catheter may extend through intermediate shaft 424 and / or inner shaft 410 and be fluidly coupled to balloon 436. In another embodiment, the lumen of inner shaft 410 is used to deliver inflation fluid (e.g., saline) to balloon 436 through one or more ports or openings disposed along inner shaft 410 in the region of inner shaft 410 disposed within balloon 436.

[0129] As shown in FIG. 7B, balloon 436 is inflated to a larger outer diameter forming an outer surface that forms a continuous transition between distal end 426 of artificial valve 408 and proximal end 420 of nose cone 414. For example, the outer surface of balloon 436 may form a curved and / or tapered surface that curves from distal end 426 and proximal end 420. As shown in FIG. 7B, in the expanded state, proximal end 438 of balloon 436 contacts distal end 426 of artificial valve 408 and distal end 439 of balloon 436 contacts proximal end 420 of nose cone 414. In some embodiments, the distal end of balloon 436 may be attached to proximal end 420 of nose cone 414 or may be integrally formed with the nose cone.

[0130] Balloon 436 may be inflated by an amount that provides this continuous transition between proximal end 420 of nose cone 414 and distal end 426 of artificial valve 408.

[0131] In some embodiments, the balloon 436 can be an expandable balloon formed from an elastic material (e.g., polyurethane or silicone). The expandable balloon 436 can be inflated to a desired size within a range of possible sizes based on the size of the prosthetic valve 408. In other embodiments, the balloon 436 can be a semi-expandable balloon formed from a material that is relatively less elastic than the materials used for expandable balloons (e.g., Pebax or high durometer polyurethane). Similar to expandable balloons, the semi-expandable balloon can be inflated to a desired size within a range of possible sizes based on the size of the prosthetic valve 408, but cannot expand or stretch to the extent possible for expandable balloons.

[0132] In still other embodiments, the balloon 436 can be a non-expandable balloon formed from a non-elastic material or a material having slight elasticity (e.g., polyester or nylon). The non-expandable balloon expands to a predetermined size when fully inflated, which can be selected based on the size of the prosthetic valve with which the balloon is used.

[0133] As shown in FIG. 7B, the inflated balloon 436 can facilitate such repositioning of the prosthetic valve 408, particularly in the distal direction, after reaching the target implantation site. For example, the continuous transition between the nose cone 414 provided by the inflated balloon 436 and the prosthetic valve 408 can enhance the operability of the prosthetic valve 408 via the delivery device 400 without the prosthetic valve contacting and / or damaging the patient's anatomical structure at the target implantation site.

[0134] When the prosthetic valve 408 is actively expanded (as shown, for example, in FIG. 6C) and implanted at the target implantation site, the balloon 436 can be contracted to the contracted state shown, for example, in FIG. 7A, and then retracted into the sheath 422 through the lumen of the expanded prosthetic valve 408. In this way, the balloon 436 can be contracted to reduce its diameter to more easily remove it from the target implantation site through the patient's vasculature without displacing the implanted valve.

[0135] In some embodiments, the distal end of the balloon 436 may be attached to the proximal end 420 of the nose cone 414.

[0136] In other embodiments, as shown in FIGS. 7C and 7D, the balloon 436 may be a pre-expanded (or pre-filled) balloon, which can be actively expanded from the compressed state (shown in FIG. 7A) to the expanded state (shown in FIGS. 7C - 7D) or configured to passively expand, as further described below.

[0137] As an example, the balloon 436 may be pre-filled with a compressible fluid or other type of compressible material (such as a hydrogel, which may be in the form of hydrogel beads) to the expanded state, and then compressed (to a smaller diameter) to fit within the sheath 422 between the nose cone 414 and the prosthetic valve 408 as shown in FIG. 7A. Next, when the sheath 422 is retracted away from the prosthetic valve 408 to expose and deploy the valve, the pre-filled balloon 436 can passively expand (by the amount of expansion based on its pre-filled size or diameter). For example, a pre-filled (e.g., pre-expanded) balloon may assume its pre-expanded size (e.g., diameter) when in the (radially) expanded state.

[0138] In some embodiments, by moving the proximal and distal ends of the balloon relative to each other, the shape of the balloon (regardless of whether pre-filled or inflated) can be changed by the user. For example, as shown in FIGS. 7C and 7D, a pre-filled balloon may be attached to a tension member 434, such as a cable or shaft, at its proximal end (e.g., the end closest to the prosthetic valve 408), or at its distal end, to a nose cone 414 and / or an inner shaft 410. The tension member 434 may be configured to apply a pulling force (e.g., an axial force in the proximal direction) or a pushing force (e.g., an axial force in the distal direction) to the proximal end of the balloon 436. Axially moving the tension member 434 relative to the inner shaft 410, or vice versa, is effective in adjusting the length and diameter of the balloon 436. In particular, retracting the tension member 434 in the proximal direction and / or advancing the inner shaft 410 in the distal direction is effective in increasing the length of the balloon 436 and decreasing its diameter (FIG. 7D) (effectively radially compressing the balloon), while advancing the tension member 434 in the distal direction and / or retracting the inner shaft 410 in the proximal direction is effective in decreasing the length of the balloon 436 and increasing its diameter (FIG. 7C) (effectively radially expanding the balloon). The balloon can be retracted into the sheath 422 at the end of the procedure by retracting both the inner shaft 410 and the tension member 434 proximally relative to the sheath 422.

[0139] In some cases, as shown in FIG. 7C, the balloon 436 may assume an expanded diameter 428 that is larger than the desired outer diameter of the balloon 436. This can occur when the proximal end 420 of the nose cone 414 and the distal end 426 of the prosthetic valve 408 are too close to each other, as indicated by a first length 430 that represents the (axial) length of the balloon 436. In these cases, as shown in FIG. 7D, it may be possible to extend the length of the balloon 436 from the first length 430 (shown in FIG. 7C) to a longer second length 432.

[0140] When the length of balloon 436 is extended to a second length 432, the outer diameter of balloon 436 decreases. In one example, the second length 432 may be selected such that, as shown in FIG. 7D, the maximum diameter of balloon 436 is equal to or slightly smaller than the outer diameter of the prosthetic valve 408 (e.g., the non-actively expanded diameter). In this way, the outer surface of balloon 436 creates a continuous (and gradual) transition between the outer diameter of prosthetic valve 408 and the outer diameter of the proximal end 420 of nose cone 414.

[0141] The dimensions including the length and filling volume of the balloon may be selected to provide a continuous transition between the proximal end 420 of nose cone 414 and the distal end 426 of prosthetic valve 408.

[0142] Furthermore, in an embodiment of a pre-filled (non-actively expandable) balloon 436, the length and filling volume of the balloon may be further selected to allow for retraction of the balloon through the lumen of prosthetic valve 408 at the end of the implantation procedure (e.g., after the valve has been actively expanded and positioned in the patient's anatomy).

[0143] In another embodiment, balloon 436 may be pre-filled with a liquid (e.g., saline). The balloon can be radially compressed by retracting tension member 434 in the proximal direction and / or advancing inner shaft 410 in the distal direction such that the diameter of balloon 436 is reduced until the diameter of balloon 436 is less than or equal to D1 and can be housed within sheath 422 during delivery of the prosthetic valve. At the implantation site, prosthetic valve 408 and balloon 436 can be deployed from sheath 422. The user can then adjust the size of balloon 436 to create a smooth transition between the prosthetic valve and the balloon, as depicted in FIG. 7C.

[0144] Since the pre-filled balloon does not require an inflation / deflation catheter, the overall structure of the delivery device 400 can be simplified. In an alternative embodiment, the balloon may be pre-filled, but can also be configured to receive additional inflation fluid during the implantation procedure to further increase the size of the balloon if necessary.

[0145] In an alternative embodiment, the configuration shown in FIGS. 7C and 7D can be used to adjust the length of the inflatable balloon either before or after inflating the balloon with an inflation medium.

[0146] In this way, the balloon of the delivery device (either actively inflatable or pre-inflated) can be configured to be disposed between the nose cone and the prosthetic valve after releasing the prosthetic valve from the outer shaft of the delivery device, thereby providing a continuous transition and filling the gap created between the nose cone and the non-compressible prosthetic valve. As a result, the prosthetic valve can be more easily repositioned at the target implantation site, if necessary, without damaging the patient's anatomy and / or the prosthetic valve.

[0147] In some embodiments, as shown in FIGS. 8A-8C, the transition element 402 is a compressible element 440 such as a compressible foam or sponge. For example, in some embodiments, the compressible element 440 may include a foam or sponge material that is compressible, relatively flexible, and / or porous. As an example, the compressible element 440 may include a compressible material such as a foam or sponge that is compressed when a compressive force is applied and is able to return (e.g., bounce back) to its resting or non-compressed size after the compressive force is removed.

[0148] Thus, the compressible element 440 may have an expanded uncompressed (e.g., stationary) state or geometry when held within the sheath 422 of the delivery device 400 (as shown in FIGS. 8C and 8D) and not compressed by the sheath. Further, the compressible element 440 may be compressible into a radially compressed state or geometry (having an outer diameter smaller than the expanded uncompressed geometry).

[0149] For example, as shown in FIG. 8A, the compressible element 440 is held in a (radially) compressed state having a first diameter 442 within the sheath 422 of the delivery device 400. The compressible element 440 is disposed within the sheath 422 in the space between the proximal end 420 of the nose cone 414 and the distal end 426 of the prosthetic valve 408 in the direction of the longitudinal central axis 418. In this way, the compressible element 440 can be disposed directly adjacent to each of the nose cone 414 and the prosthetic valve 408. The inner shaft 410 can extend through the compressible element 440. The compressible element 440 may be attached to the nose cone 414 and / or the inner shaft 410.

[0150] The compressible element 440 is configured to expand to its stationary (e.g., expanded uncompressed) state between the nose cone 414 and the prosthetic valve 408 when the sheath 422 moves away from the compressible element 440 and the prosthetic valve 408 and no longer covers them.

[0151] For example, as shown in FIG. 8B, when the sheath 422 is partially pulled proximally 444 from the nose cone 414, the distal portion of the compressible element 440 (e.g., the portion disposed adjacent to the nose cone 414) is exposed and exposed to the external environment (outside the sheath 422). As a result, the distal portion of the compressible element 440, which is no longer disposed inside the sheath 422, can expand to a diameter larger than the first diameter 442. However, the portion (e.g., the proximal portion) that remains confined within the sheath 422 maintains its compressed first diameter 442.

[0152] In FIG. 8C, the sheath 422 is pulled back in the proximal direction 444 to expose the entire further compressible element 440 and the prosthetic valve 408. As a result, the prosthetic valve 408 expands to a partially expanded state, which in some embodiments can also be a passively expanded state. Thus, the diameter of the prosthetic valve 408 may be larger in its passively expanded state than its radially compressed diameter shown in FIG. 8A.

[0153] After being fully deployed from the sheath 422 (e.g., disposed outside the sheath), the compressible element 440 expands to its resting state (also referred to as its expanded and uncompressed state) having a second diameter 450, as shown in FIG. 8C. The second diameter 450 is larger than the first diameter 442. In the expanded state, the proximal end 446 of the compressible element 440 can contact the distal end 426 of the prosthetic valve 408, and the distal end 448 of the compressible element 440 can contact the proximal end 420 of the nose cone 414.

[0154] In this way, due to its compressible nature, the compressible element 440 is configured to passively (e.g., without active actuation from an external actuation source) expand from its compressed state to its expanded and uncompressed state when removed from within the sheath 422. This is due to the inner wall of the sheath 422 no longer applying an inward compressive force against the outer surface of the compressible element 440.

[0155] As shown in FIG. 8C, the outer surface of the compressible element 440 creates a continuous transition from the distal end 426 of the prosthetic valve 408 to the proximal end 420 of the nose cone 414. For example, the outer surface of the compressible element 440 may form a curved surface that curves between the distal end 426 and the proximal end 420.

[0156] For example, in some embodiments, the compressible element 440 tapers in diameter from a second diameter 450 in the middle portion of the compressible element 440 to the proximal end 420 of the nose cone 414, and tapers in diameter from the second diameter 450 in the middle portion to the distal end 426 of the artificial valve 408.

[0157] In some embodiments, as shown in FIG. 8D, the compressible element 440 has a proximal taper region 452 that tapers to a third diameter 454 at the most proximal end 456 of the compressible element 440. The third diameter 454 is smaller than the diameter of the artificial valve 408 (in the uncompressed state shown in FIG. 8D) and smaller than the second diameter 450.

[0158] In some embodiments, as shown in FIG. 8D, the proximal taper region 452 is disposed within the artificial valve 408 and extends partially into the artificial valve 408 from the distal end 426 of the artificial valve 408. This taper allows the distal end of the artificial valve to overlap partially with the compressible element 440, ensuring a smooth transition between the artificial valve 408 and the compressible element 440. Further, this taper allows the compressible element 440 to be compressed against either the distal lip of at least a partially expanded frame or sheath 422 of the artificial valve 408 and to be easily retracted (in the proximal direction 444) at the end of the valve implantation procedure. Thus, in some embodiments, the compressible element 440 having the proximal taper region 452 can be more easily retracted through the artificial valve 408 and removed from the implantation site and the patient.

[0159] In some embodiments, the proximal end 446 of the compressible element 440 (or, in embodiments where the compressible element has a proximal taper region 452, the most proximal end 456) is configured to apply a pulling force in the proximal direction 444 to retract the compressible element 440 closer to the prosthetic valve 408 at the end of the procedure, or to retract it away from the implantation site, (instead of or in addition to being attached to the inner shaft 410 or nose cone 414) and may be attached to a tensile member such as a cable or shaft (not shown in FIGS. 8A - 8D).

[0160] Due to its compressible nature, the compressible element 440 can be compressed to a smaller diameter (e.g., smaller than the second diameter 450) while being removed from the implantation site at the end of the implantation procedure and radially expanded such that it cannot interfere with or displace the implanted prosthetic valve 408.

[0161] In this way, the compressible element of the delivery device (e.g., a compressible foam or sponge) may be configured to be disposed between the nose cone and the prosthetic valve after releasing the prosthetic valve from the outer shaft of the delivery device, thereby providing a continuous transition between the nose cone and the partially expanded prosthetic valve. As a result, the prosthetic valve can be more easily repositioned at the target implantation site, if necessary, without damaging the patient's anatomy and / or the prosthetic valve.

[0162] In some embodiments, as shown in FIGS. 9A - 9C, the transition element 402 is an expandable mechanical element 460 with an expandable frame 462. The mechanical element 460 is movable from a radially compressed state (shown in FIG. 9A) to an expanded state (shown in FIG. 9B). In its expanded state, the mechanical element 460 is configured to provide an axially continuous transition between the nose cone 414 and the frame of the prosthetic valve 408.

[0163] As shown in FIGS. 9A - 9C, the expandable frame 462 can include a plurality of arms 464 attached to the proximal region of the nose cone 414. In some embodiments, the distal end 468 of each arm 464 can be coupled to the proximal end 420 of the nose cone 414.

[0164] In some embodiments, the distal end 468 of each arm 464 can be coupled to the proximal end 420 of the nose cone 414 via a hinged connection 466. For this reason, each arm 464 may be configured to pivot about its hinged connection 466 between a compressed state (shown in FIG. 9A) and an expanded state (shown in FIG. 9B).

[0165] Each arm 464 extends proximally in the axial direction from its distal end 468 towards the proximal end 470 of the arm 464 and towards the artificial valve 408. The proximal end 470 of each arm 464 may be a free end that is not attached to another component of the delivery device 400 and is thus configured to move freely from the compressed state to the expanded state.

[0166] In some embodiments, the arms 464 can be covered by a circumferentially flexible cover 472 (shown in FIGS. 9A - 9B). The cover 472 may include a fabric (e.g., cloth), a flexible polymer, and / or the like. For example, the cover 472 can overlap and cover the outer surface of each arm 464 and surround the frame 462 around the periphery of the mechanical element 460. In this way, the mechanical element 460 can form a sleeve with the mechanically expandable frame 462 and the cover 472.

[0167] As shown in FIG. 9A, the frame 462 can be held in its radially compressed state within the sheath 422 when the sheath 422 surrounds both the artificial valve 408 and the mechanical element 460 of the frame and its arms 464 are in contact with the inner wall of the sheath 422 and spring - biased. For example, the frame 462 can be held in its radially compressed state by an inward compressive force from the inner wall surrounding the sheath 422.

[0168] Next, when the sheath 422 is removed to expose the frame 462 (e.g., when retracted in a proximal direction away from the nose cone 414), the frame 462 assumes an expanded configuration with a diameter that tapers from the artificial valve 408 to the nose cone 414.

[0169] For example, as shown in FIG. 9B, when the sheath 422 is axially moved away from the frame 462 to expose the frame 462 and the artificial valve 408, each proximal end 470 of the arms 464 can be pushed radially outward (with respect to the longitudinal central axis) due to the preloaded spring force. Each distal end 468 of the arms 464 remains fixed to the nose cone 414, but each arm can pivot about its corresponding hinged connection 466 to the nose cone 414 such that the proximal end 470 of each arm 464 expands radially outward to an expanded diameter 474 (shown in FIG. 9B) that is larger than the compressed diameter 476 of the frame 462 (shown in FIG. 9A).

[0170] As shown in FIG. 9B, in its expanded state, the frame 462 tapers towards the proximal end 420 of the nose cone 414. For example, in some embodiments, in the expanded state, the proximal end 470 of each arm 464 of the frame 462 contacts the distal end 426 of the artificial valve 408, and the distal end 468 of each arm 464 of the frame 462 contacts the proximal end 420 of the nose cone 414.

[0171] In this way, the mechanical element 460 extends between and forms a continuous transition between the nose cone 414 and the artificial valve 408 after the artificial valve 408 is deployed from within the sheath 422 and assumes at least a partially expanded configuration (as shown in FIG. 9B). Further, the mechanical element 460 fills a gap that can be created between the at least partially expanded artificial valve 408 and the nose cone 414 in another way, as described above with reference to FIGS. 6B - 6C.

[0172] In some embodiments, as shown in FIG. 9C, the mechanical element 460 can further include a compression mechanism 478 configured to recompress the frame 462 to its compressed state to facilitate the retraction of the frame 462 from the implantation site, through the lumen of the expanded artificial valve 408, and into the sheath 422 upon completion of the implantation procedure. As a result, the mechanical element 460 and the nose cone 414 can be retracted in the proximal direction, away from the implantation site and through the lumen of the artificial valve, without interfering with or displacing the implanted artificial valve.

[0173] It should be noted that FIG. 9C shows the mechanical element 460 without the cover 472 surrounding the frame 462 for illustrative purposes. The mechanical element 460 may or may not include the cover 472 in different embodiments. In embodiments where the mechanical element 460 includes the cover 472, the compression mechanism 478 may be configured to surround the cover 472 and compress the cover 472 and the frame 462 together into a compressed state.

[0174] As shown in FIG. 9C, in some embodiments, the compression mechanism 478 includes an adjustable loop 480 (e.g., a loop of wire or suture) that wraps around or surrounds the arm 464 of the frame 462, and an actuating member 482 (e.g., a wire or suture) configured to reduce the size of the loop to compress the frame 462. Pulling the actuating member 482 in the proximal direction (with the handle of the delivery device) is effective in reducing the diameter of the loop, thereby radially compressing the mechanical element 460. Further details of such a compression mechanism can be found in Patent Document 14, the entire text of which is incorporated herein by reference.

[0175] In this manner, the expandable mechanical element of the delivery device is configured to be disposed between the nose cone and the prosthetic valve after releasing the prosthetic valve from the outer shaft of the delivery device, thereby providing a continuous transition between the nose cone and the uncompressed prosthetic valve. As a result, the prosthetic valve can be more easily repositioned at the target implantation site, if desired, without damaging the patient's anatomy and / or the prosthetic valve.

[0176] FIG. 10 shows a method 1000 for delivering a prosthetic valve to a target implantation site according to one embodiment. The prosthetic valve may be any of the prosthetic valves described herein, such as the prosthetic valve 10 of FIG. 1, the prosthetic valve 100 of FIGS. 2-4, the prosthetic valve 308 of FIGS. 5-6C, and the prosthetic valve 408 of FIGS. 7A-9C.

[0177] At 1002, method 1000 includes advancing a delivery device of a transcatheter delivery system (e.g., the delivery device 300 of FIGS. 5-6C and / or the delivery device 400 of FIGS. 7A-9C) to a target implantation site (e.g., the heart) of a patient, the delivery device comprising an outer shaft having a distal end portion that forms a sheath surrounding a radially compressed prosthetic valve proximate the proximal end of the nose cone of the delivery device. An example of the sheath of the outer shaft of the delivery device surrounding the radially compressed prosthetic valve is shown in FIGS. 6A, 7A, 8A, and 9A as described above.

[0178] In 1004, after reaching the target implantation site, method 1000 includes the step of retracting (or moving, e.g., axially moving) the distal end portion of the outer shaft away from the nose cone to expose the prosthetic valve, whereby the prosthetic valve can expand to a partially expanded state (e.g., as shown in FIGS. 6B, 7B-7D, 8C-8D, and 9B). For example, when the sheath is axially moved away from the prosthetic valve, the prosthetic valve can expand to a partially expanded state (e.g., passively, without an active actuating force from an external mechanism) as described above with reference to FIG. 6B. In other cases, when the prosthetic valve is removed from the sheath, it may remain in a fully compressed state.

[0179] In 1006, if repositioning (e.g., recrossing of the native valve) is required, method 1000 includes the step of expanding the transition element of the delivery device in the space formed between the proximal end of the nose cone and the distal end of the prosthetic valve in a partially expanded state or a fully compressed state. The transition element may include one of the transition elements described herein with reference to FIGS. 7A-9C. For example, in some embodiments, the transition element is an inflatable balloon, and the step of expanding the transition element includes expanding the inflatable balloon from a collapsed state to an inflated state (shown in FIGS. 7A-7B) between the nose cone and the partially expanded (e.g., uncompressed) or fully compressed prosthetic valve.

[0180] In other embodiments, the transition element is a pre-inflated balloon, and the step of expanding the transition element includes passively expanding the pre-inflated balloon from a radially compressed state (shown in FIG. 7A) to a radially expanded state (shown in FIGS. 7C-7D) between the nose cone and the prosthetic valve, and the pre-inflated balloon assumes its pre-inflated size when in the radially expanded state. Alternatively, the pre-filled balloon can be actively expanded to change its shape from a radially compressed state to a radially expanded state.

[0181] In yet other embodiments, the transition element is a compressible element that includes one of a compressible form and a sponge material, and the step of expanding the transition element includes passively expanding the compressible element from a compressed state (shown in FIG. 8A) to an expanded uncompressed state (shown in FIGS. 8C and 8D), and the compressible element is in its resting state when in the expanded state. In other embodiments, the transition element is a mechanical element with an expandable frame having a distal end coupled to the nose cone, and the step of expanding the transition element includes expanding the proximal end of the expandable frame from a compressed state (shown in FIG. 9A) to an expanded state (shown in FIG. 9B). If necessary, the position of the prosthetic valve can be adjusted to contact or be partially overlapped with the proximal end of the transition element at the distal end of the prosthetic valve.

[0182] In 1008, method 1000 optionally (e.g., if required for treatment due to inaccurate placement) includes, after expanding the transition element, repositioning the prosthetic valve in a partially expanded state or a fully compressed state to the target implantation site by adjusting components of the delivery device. The more continuous transition provided by the transition element between the nose cone of the delivery device and the prosthetic valve can allow the valve to be easily manipulated in the distal or proximal direction during repositioning without causing degradation to the patient's anatomy and / or the prosthetic valve.

[0183] At 1010, method 1000 includes actively expanding the prosthetic valve radially to a radially expanded state after repositioning the prosthetic valve or after positioning the prosthetic valve (without repositioning). For example, the step of actively expanding the prosthetic valve may include actuating one or more actuator assemblies of the delivery device (e.g., actuator assembly 306 shown in FIGS. 6A-6C and / or actuator assembly 406 shown in FIGS. 7A-9C) to actively expand the prosthetic valve to its expanded diameter (e.g., D3 shown in FIG. 6C). In an alternative embodiment, the step of actively expanding the prosthetic valve may include filling an inflatable balloon of a balloon catheter around which the prosthetic valve is attached to radially expand the prosthetic valve.

[0184] At 1012, method 1000 includes retracting the nose cone and transition element of the delivery device proximally away from the implantation site and removing the delivery device from the patient's body. In some embodiments, the method of 1012 may include compressing the transition element to a geometry (e.g., diameter) smaller than the diameter in the expanded state. For example, if the transition element is an inflatable balloon, the method of 1012 may include deflating the balloon and then retracting the nose cone and balloon proximally through the lumen of the prosthetic valve. In another example, if the transition element is a compressible element (e.g., a compressible foam or sponge), the method of 1012 may include pulling the nose cone and compressible element proximally through the lumen of the prosthetic valve and passively compressing the compressible element radially to a smaller state (e.g., via pressure contacting the lumen of the prosthetic valve). In yet another example, if the transition element is a mechanical element having an expandable (and compressible) frame, the method of 1012 may include recompressing the mechanical element to its compressed state via a compression mechanism (e.g., as shown in FIG. 9C) and then pulling the nose cone and the compressed mechanical element proximally through the lumen of the prosthetic valve.

[0185] In this way, a more continuous transition between at least partially expanded or fully compressed prosthetic valves (e.g., after removal from the sheath of a delivery device) provided by one of the transition elements described herein and the nose cone of the delivery device can enable easier repositioning of the prosthetic valve at or near the target implantation site within the patient's body. For example, at least partially expanded or fully compressed prosthetic valves can be more easily moved distally and / or proximally with respect to the target implantation site to reposition the prosthetic valve, and when the transition element is utilized, the prosthetic valve can be fully expanded and implanted at the target implantation site without damaging the patient's body and / or the prosthetic valve. Further, by having a compressible or actively expandable and compressible transition element, the transition element can be stored in a compressed state inside the outer shaft of the delivery device during operation of the delivery device to the target implantation site and then expanded to its expanded uncompressed state after the prosthetic valve is exposed from the distal end of the outer shaft, thereby forming a more continuous transition into the space formed between the exposed prosthetic valve and the nose cone. The compressible transition element can then be recompressed through the lumen of the expanded prosthetic valve prior to removing the delivery device from the implantation site, thereby enabling easier removal without interfering with or displacing the implanted prosthetic valve.

[0186] General Considerations It should be understood that the disclosed embodiments can be configured to deliver and implant an artificial device at any of the heart's native valve annuli (e.g., the pulmonary valve annulus, the mitral valve annulus, and the tricuspid valve annulus) and can be used with any of a variety of delivery approaches (e.g., retrograde, antegrade, transseptal, transventricular, transatrial, etc.).

[0187] For the purposes of this specification, certain aspects, advantages, and novel features of embodiments of the present disclosure are described herein. The disclosed methods, apparatuses, and systems should in no way be construed as limiting. Rather, the present disclosure is directed to all novel and non-obvious features and aspects of the various disclosed embodiments, alone and in various combinations and sub-combinations with each other. The methods, apparatuses, and systems are not limited to any particular aspect or feature, or combination thereof, and the disclosed embodiments do not require the presence of any one or more particular advantages or the solving of any particular problems. The techniques of any example may be combined with the techniques described in any one or more of the other examples. In view of the many possible embodiments to which the principles of the disclosed techniques may be applied, it should be recognized that the illustrated embodiments are only preferred examples and should not be regarded as limiting the scope of the disclosed techniques.

[0188] Some of the operations of the disclosed embodiments are described in a particular order for convenient presentation, but such presentation should be understood to encompass rearrangement, unless a particular order is required by the specific language set forth below. For example, operations described sequentially may in some cases be rearranged or performed simultaneously. Further, for the sake of brevity, the accompanying drawings may not show the various ways in which the disclosed method can be used in combination with other methods. Further, in this specification, terms such as "provide" or "achieve" may be used to describe the disclosed method. These terms are high-level abstractions of the actual actions being performed. The actual actions corresponding to these terms may vary depending on the particular embodiment and are readily identifiable by those skilled in the art.

[0189] As used herein, with respect to a transcatheter delivery system, an artificial heart valve, a delivery device, a delivery apparatus, and a transition element, "proximal" refers to the position, orientation, or portion of a component that is closer to the handle of the delivery system that is outside the patient, and "distal" refers to the position, orientation, or portion of a component that is further away from the handle (further into the patient's body). The terms "longitudinal" and "axial" refer to an axis that extends in the proximal and distal directions, unless otherwise explicitly defined.

[0190] As used in this specification and the claims, the singular forms "a", "an", and "the" include the plural forms unless the context clearly dictates otherwise. Further, the term "includes" means "comprises". Further, the terms "coupled" and "connected" generally mean electrically, electromagnetically, and / or physically (e.g., mechanically or chemically) coupled or connected, and do not exclude the presence of intermediate elements between the coupled or related articles unless a specific contrary statement is made.

[0191] Directions and other relative designations (e.g., inside, outside, up, down, etc.) may be used to facilitate the discussion of the drawings and principles of this specification, but are not intended to be limiting. For example, specific terms such as "inside", "outside", "up", "down", "inner", "outer", etc. may be used. Such terms are used, if applicable, to clarify the description to some extent when dealing with relative relationships, particularly with respect to the illustrated embodiments. However, such terms do not mean absolute relationships, positions, and / or directions. For example, with respect to an object, if the object is turned over, the "up" portion can become the "down" portion. Nevertheless, it is the same member and the object remains the same. As used herein, "and / or" means "and" or "or", as well as "and" and "or".

[0192] Considering the many possible embodiments to which the principles of the disclosed invention can be applied, it should be recognized that the illustrated embodiments are only preferred examples of the invention and should not be regarded as limiting the scope of the invention. Rather, the scope of the invention is defined by the following claims. Accordingly, we claim as our invention all that comes within the scope and spirit of these claims.

Explanation of Reference Numerals

[0193] 10 Artificial valve 12 Frame 14 End, inflow end 16 End, outflow end 18 Valve structure 20 Actuator 22 Valve tip 24 Cross-linking part 26 Clamp 28 Strut 30 Pin 32 Push-pull mechanism 34 Inner member 34a Distal end portion 36 Outer member 38 Top 40 Lock mechanism 42 Inner member 100 Artificial valve 102 Frame 104 End 106 End 110 Threaded sleeve, sleeve 112 Stopper 114 Opening 116 Strut 118 Pivot member 200 Actuator assembly 202 Actuator member 204 Cover tube 206 Support tube 208 Screw, threaded screw, support tube 300 Delivery device, delivery device 302 Handle 304 Outer shaft 306 Actuator assembly 308 Artificial valve 310 Inner shaft 312 Distal end portion 314 Nose cone 316 Knob 318 Knob 320 Knob 322 Sheath 324 Intermediate shaft 326 Distal end 400 Delivery device 402 Transition element 404 Outer shaft 406 Actuator assembly 408 Artificial valve 410 Inner shaft 412 Distal end portion 414 Nose cone 416 Proximal end 418 Longitudinal central axis 420 Proximal end 422 Sheath 424 Intermediate shaft 426 Distal end 428 Expansion diameter 434 Tension member 436 Balloon 438 Proximal end 439 Distal end 440 Element 444 Proximal direction 446 Proximal end 448 Distal end 452 Proximal taper region 456 End 460 Mechanical element 462 Frame 463 Frame 464 Arm 466 Hinge type connection part 468 Distal end 470 Proximal end 472 Cover 478 Compression mechanism 480 Loop 482 Actuating member D1 Minimum diameter D2 Partially expanded diameter D3 Expanded diameter

Claims

【Claim 1】 The assembly described in the specification and drawings.

Images