Expandable transition element for transcatheter delivery device - Patent application

Abstract

A transcatheter delivery system with an expandable transition element is disclosed. In one example, the assembly includes a prosthetic valve and a delivery device. The delivery device can include an outer shaft having a distal end portion forming a sheath configured to surround the prosthetic valve in a radially compressed configuration, an inner shaft disposed within the outer shaft and including a nosecone disposed at a distal end of the inner shaft, the nosecone disposed outside the outer shaft at the distal end portion of the outer shaft, and an expandable transition element configured to expand from an unexpanded state within the outer shaft to an expanded state outside the outer shaft, wherein in the expanded state, the transition element forms a continuous transition from the nosecone to the prosthetic valve when the sheath moves away from the nosecone to expose the prosthetic valve.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Application No. 62 / 928,973, entitled “EXPANDABLE TRANSITION ELEMENT FOR A TRANSCATHETER DELIVERY DEVICE,” filed October 31, 2019, the entire contents of which are incorporated herein by reference.

[0002] The present disclosure relates to embodiments of assemblies and associated methods for providing a more continuous transition between a prosthetic medical device and a nose cone of a delivery apparatus configured to deliver the prosthetic medical device to a target implantation site via a transition element. [Background technology]

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

[0004] Prosthetic valves that rely on mechanical actuators for expansion can be referred to as "mechanically expandable" prosthetic heart valves. The actuators typically take the form of pull cables, sutures, wires, and / or shafts configured to transmit an expansion force from the handle of the delivery device to the prosthetic valve.

[0005] In some embodiments, after the prosthetic valve is deployed from the sheath of the delivery device, but before it is actively expanded by the actuator of the delivery device, the prosthetic valve can assume a partially expanded (e.g., uncompressed) diameter that is larger than its fully compressed diameter (after being crimped) and smaller than its fully expanded diameter (after being expanded by the actuator of the delivery device). This expansion of the diameter can result in a gap being formed between the nose cone of the delivery device and the distal end of the prosthetic valve. This gap can create a discontinuity between the prosthetic valve and the nose cone, making repositioning the prosthetic valve at the target implantation site difficult. For example, in some embodiments, the gap can cause the prosthetic valve to unnecessarily contact the patient's anatomy during repositioning of the prosthetic valve. Thus, an improvement in the delivery device that reduces gap formation between the nose cone of the delivery device and the prosthetic valve (in some instances, after deployment from the sheath of the delivery device) is desirable. [Prior art documents] [Patent documents]

[0006] [Patent Document 1] U.S. Patent No. 6,730,118 [Patent Document 2] U.S. Patent No. 7,393,360 [Patent Document 3] U.S. Patent No. 7,510,575 [Patent Document 4] U.S. Patent No. 7,993,394 [Patent Document 5] U.S. Patent No. 8,652,202 [Patent Document 6] US Patent Application Publication No. 2018 / 0325665 [Patent Document 7] U.S. Patent Application No. 15 / 831197 [Patent Document 8] U.S. Patent Application No. 62 / 515437 [Patent Document 9] U.S. Patent Application No. 62 / 548855 [Patent Document 10] US Patent Application Publication No. 2015 / 0135506 [Patent Document 11] US Patent Application Publication No. 2014 / 0296962 [Patent Document 12] U.S. Patent Application No. 62 / 430810 [Patent Document 13] U.S. Patent Application No. 15 / 978459 [Patent Document 14] U.S. Patent Application No. 62 / 799678 [Patent Document 15] US Patent Publication No. 2018 / 0153689 Summary of the Invention [Means for solving the problem]

[0007] Disclosed herein are assemblies including a prosthetic valve and a delivery apparatus, and associated methods for using the delivery apparatus to deliver and implant the prosthetic valve at a target implantation site. The delivery apparatus (sometimes referred to herein as a delivery device) can be used to deliver an implantable medical device, such as a prosthetic heart valve, to a target site in a patient, such as the heart. In some embodiments, the delivery apparatus 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 the prosthetic heart valve or other implantable medical device.

[0008] In some embodiments, the delivery device may be configured to have an expandable transition element that is disposed in a non-expanded (e.g., compressed) state within the outer shaft of the delivery device during delivery (e.g., manipulation) of 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 which the transition element forms a continuous transition from the nose cone of the delivery device to the prosthetic valve as the distal end of the outer shaft moves away from the nose cone to expose the prosthetic valve. The expandable transition element may be any of an inflatable balloon, a pre-inflated balloon, a compressible element (e.g., a sponge), and a mechanical element (having an expandable frame).

[0009] In one exemplary embodiment, the assembly includes a prosthetic valve and a delivery device, the delivery device including an outer shaft having a distal end portion forming a sheath configured to surround the prosthetic valve in a radially compressed configuration, an inner shaft, the inner shaft disposed within the outer shaft and including a nosecone disposed at a distal end of the inner shaft, the nosecone disposed outside of the outer shaft at the distal end portion of the outer shaft, and an expandable transition element configured to expand from an unexpanded state within the outer shaft to an expanded state outside of the outer shaft, in the expanded state the transition element forms a continuous transition from the nosecone to the prosthetic valve as the sheath moves away from the nosecone to expose the prosthetic valve.

[0010] In some embodiments, the delivery device further comprises 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 be expanded from a contracted state prior to removal of the prosthetic valve from the sheath to an expanded state after removal of the prosthetic valve from the sheath. Further, in some embodiments, when the balloon is in the contracted state, the balloon is disposed in a radially compressed configuration within the sheath and between the nosecone and the distal end of the prosthetic valve. In some embodiments, when the balloon is in the inflated state, the balloon is disposed outside the outer shaft and between the nosecone and the distal end of the prosthetic valve.

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

[0014] In some embodiments, the balloon is a semi-compliant balloon comprising Pebax.

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

[0016] In some embodiments, the balloon is a pre-inflated balloon that is pre-inflated to an expanded state 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.

[0017] In some embodiments, the transition element is a compressible element comprising one or more of a compressible foam and a sponge, hi some embodiments, a proximal end of the compressible element tapers inwardly toward the central longitudinal 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 comprising a distal end attached to the nosecone and a proximal end not attached to the 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 a periphery of the expandable frame. In some embodiments, the mechanical element further comprises a compression mechanism configured to recompress the frame from the expanded state to the 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 nosecone.

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

[0021] In another representative embodiment, a method includes advancing a delivery device of a transcatheter delivery system to a target implantation site of a patient, the delivery device including an outer shaft having a distal end portion proximate a proximal end of a nose cone of the delivery device to form a sheath surrounding a radially compressed prosthetic valve; 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 nosecone.

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

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

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

[0026] In some embodiments, the transition element is an inflatable balloon, and expanding the transition element comprises inflating the inflatable balloon from a deflated state to an inflated state.

[0027] In some embodiments, the inflatable balloon is a compliant balloon formed from an elastic material, and inflating the inflatable balloon from a deflated state to an inflated state includes inflating 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-compliant balloon comprising Pebax, and inflating the inflatable balloon from a deflated state to an inflated state comprises inflating 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-compliant balloon formed from a non-elastic material, and inflating the inflatable balloon from a deflated state to an inflated state includes inflating 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 nosecone.

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

[0032] In some embodiments, the transition element is a compressible element comprising one of a compressible foam and sponge material, and expanding the transition element comprises passively expanding the compressible element from a compressed state to an expanded, uncompressed state, the compressible element being in its resting state when in the expanded state.

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

[0034] In another exemplary embodiment, an assembly can include a mechanically expandable prosthetic valve with a distal end and a proximal end, and a delivery device. The delivery device can include 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, an inner shaft, the inner shaft being disposed within the outer shaft and including a nosecone disposed at a distal end of the inner shaft, the nosecone disposed outside of the outer shaft proximate the distal end of the prosthetic valve, and an expandable transition element configured to expand from an unexpanded state within the outer shaft to an expanded state outside of the outer shaft, where in the expanded state the transition element forms a continuous transition from the proximal end of the nosecone to the distal end of the prosthetic valve as the sheath moves away from the nosecone to expose the prosthetic valve.

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

[0036] In some embodiments, the transition element is an inflatable balloon configured to be inflated from a contracted state prior to removal of the prosthetic valve from the sheath to an expanded state after removal of the prosthetic valve from the sheath.

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

[0038] In some embodiments, the balloon is a semi-compliant balloon comprising Pebax.

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

[0040] In some embodiments, the transition element is a pre-inflated balloon that is pre-inflated to an expanded state 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.

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

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

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

[0044] In some embodiments, the transition element is an expandable mechanical element comprising an expandable frame with multiple arms, each arm of the multiple arms comprising 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 when disposed within a sheath to an expanded state when the sheath is moved away from the mechanical element.

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

[0046] In another exemplary embodiment, an assembly includes a prosthetic valve and a delivery device, the delivery device including an outer shaft having a distal end portion forming a sheath configured to surround the prosthetic valve in a radially compressed configuration, an inner shaft, the inner shaft disposed within the outer shaft and including a nosecone disposed at a distal end of the inner shaft, the nosecone disposed outside of the outer shaft, the outer shaft and the inner shaft configured to move axially relative to one another to move the nosecone 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 nosecone and configured to expand from an unexpanded state within the outer shaft to an expanded state outside the outer shaft, the transition element being in an unexpanded state when the sheath covers the prosthetic valve and the transition element and in an expanded state when the sheath moves away from the nosecone to expose the prosthetic valve, and in the expanded state the transition element forms a continuous transition from the nosecone to the prosthetic valve.

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

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

[0049] In some embodiments, the at least one actuator assembly is configured to radially expand the prosthetic 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 an inflation fluid and expand from a deflated state to an inflated state.

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

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

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

[0055] In some embodiments, the balloon is a semi-compliant balloon comprising Pebax.

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

[0057] In some embodiments, the balloon is a pre-inflated balloon that is pre-inflated to an expanded state 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.

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

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

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

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

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

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

[0064] 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 nosecone.

[0065] The above and other objects, features and advantages of the present invention will become more apparent from the following detailed description of the preferred embodiments taken in conjunction with the accompanying drawings. [Brief description of the drawings]

[0066] [Figure 1] FIG. 1 is a perspective view of an exemplary embodiment of a prosthetic heart valve. [Diagram 2] FIG. 2 is a perspective view of a portion of another exemplary embodiment of a prosthetic heart valve. [Diagram 3]3 is a side view of the frame of the prosthetic heart valve of FIG. 2 shown in a radially folded configuration. [Figure 4] 3 is a side view of the frame of the prosthetic heart valve of FIG. 2 shown in a radially expanded configuration. [Diagram 5] FIG. 1 is a side view of one embodiment of a prosthetic valve delivery device. [Figure 6A] 6 is a side view of a portion of the delivery device of FIG. 5 during a stage of a prosthetic valve installation procedure. [Figure 6B] 6 is a side view of a portion of the delivery device of FIG. 5 during a stage of a prosthetic valve installation procedure. [Figure 6C] 6 is a side view of a portion of the delivery device of FIG. 5 during a stage of a prosthetic valve installation procedure. [Figure 7A] 1 illustrates a side view of a portion of a delivery device with a transition element configured to be positioned between a nose cone of the delivery device and an uncompressed prosthetic valve, the transition element comprising a balloon. [Figure 7B] 1 illustrates a side view of a portion of a delivery device with a transition element configured to be positioned between a nose cone of the delivery device and an uncompressed prosthetic valve, the transition element comprising a balloon. [Figure 7C] 1 illustrates a side view of a portion of a delivery device with a transition element configured to be positioned between a nose cone of the delivery device and an uncompressed prosthetic valve, the transition element comprising a balloon. [Figure 7D] 1 illustrates a side view of a portion of a delivery device with a transition element configured to be positioned between a nose cone of the delivery device and an uncompressed prosthetic valve, the transition element comprising a balloon. [Figure 8A] 1 illustrates a side view of a portion of a delivery device with a transition element configured to be positioned between a nose cone of the delivery device and a non-compressed prosthetic valve, the transition element comprising a compressible element. [Figure 8B] 1 illustrates a side view of a portion of a delivery device with a transition element configured to be positioned between a nose cone of the delivery device and a non-compressed prosthetic valve, the transition element comprising a compressible element. [Figure 8C]1 illustrates a side view of a portion of a delivery device with a transition element configured to be positioned between a nose cone of the delivery device and a non-compressed prosthetic valve, the transition element comprising a compressible element. [Figure 8D] 1 illustrates a side view of a portion of a delivery device with a transition element configured to be positioned between a nose cone of the delivery device and a non-compressed prosthetic valve, the transition element comprising a compressible element. [Figure 9A] 1 illustrates a side view of a portion of a delivery device with a transition element configured to be positioned between a nose cone of the delivery device and an uncompressed prosthetic valve, the transition element comprising a mechanical element. [Figure 9B] 1 illustrates a side view of a portion of a delivery device with a transition element configured to be positioned between a nose cone of the delivery device and an uncompressed prosthetic valve, the transition element comprising a mechanical element. [Figure 9C] 1 illustrates a side view of a portion of a delivery device with a transition element configured to be positioned between a nose cone of the delivery device and an uncompressed prosthetic valve, the transition element comprising a mechanical element. [Figure 10] 1 is a flowchart of a method for delivering a prosthetic valve to a target implantation site using a delivery device with an expandable transition element, according to one embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0067] Described herein are examples of prosthetic valves, delivery apparatuses (or devices) configured to deliver the prosthetic valves to a target implantation location within a body, and methods of using the delivery apparatus to deliver and implant the prosthetic valves to a target implantation site. The prosthetic valve (e.g., a prosthetic heart valve) can include a frame with 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 proximal and / or adjacent to the distal shoulder / nose cone of the delivery apparatus when disposed within the outer shaft of the delivery apparatus. For example, the distal end can be directed downstream from the proximal end of the frame when the delivery apparatus with the prosthetic valve disposed therein is advanced through the patient's lumen toward the target implantation site.

[0068] The delivery device may include an outer shaft having a distal end portion that forms a sheath (or capsule) configured to surround the prosthetic valve in a radially compressed configuration during advancement of the delivery device to the target implantation site. The delivery device may further include an inner shaft, the inner shaft disposed within the outer shaft and the inner shaft including a nosecone disposed at a distal end of the inner shaft, the nosecone disposed outside the outer shaft at the distal end portion of the outer shaft (while the outer shaft covers the prosthetic 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 form a continuous transition from the nosecone to the prosthetic valve axially relative to a central longitudinal axis of the delivery device as the sheath moves away from the nosecone to expose the prosthetic valve. As a result, the prosthetic valve may be more easily repositioned through the delivery device at the target implantation site without causing undesired contact between the sides of the patient's anatomy and the prosthetic valve, which may potentially cause damage to the anatomy or the valve.

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

[0070] FIG. 1 illustrates an exemplary prosthetic valve 10 according to one embodiment. The prosthetic 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 prosthetic valve 10 can be implanted within a native aortic valve annulus, but can also be implanted in other locations of the heart, including within a native mitral valve, native pulmonary valve, and native tricuspid valve. The prosthetic valve 10 can include 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 prosthetic valve into a native aortic valve in a transfemoral retrograde delivery approach. Thus, in the delivery configuration of the prosthetic valve, the outflow end 16 is the most proximal end of the prosthetic valve. In other embodiments, the inflow end 14 can be coupled to a 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 a delivery device (and thus is the most proximal end of the prosthetic valve in the delivery configuration) when delivering the prosthetic valve to a native mitral valve via a transseptal delivery approach.

[0072] The prosthetic valve 10 may also include a valve structure 18 coupled to the frame 12 and configured to regulate the flow of blood through the prosthetic valve 10 from the inflow end to the outflow end. The prosthetic valve 10 may further include a plurality of actuators 20 attached to and evenly spaced about an inner surface of the frame 12. Each of the actuators 20 may be configured to form a releasable connection with one or more corresponding actuators of a delivery device, as described further below.

[0073] The valve structure 18 may, for example, comprise a leaflet assembly with one or more leaflets 22 (three leaflets 22 in the illustrated embodiment) made of a flexible material. The leaflets 22 of the leaflet assembly may be made entirely or partially from a biological material, a biocompatible synthetic material, or other such material. Suitable biological materials may include, for example, bovine pericardium (or pericardium from other sources). The leaflets 22 may be arranged to form commissures 24, which may, for example, be attached to respective actuators 20. Further details regarding transcatheter prosthetic heart valves, including the manner in which the valve structure may be coupled to the frame 12 of the prosthetic valve 10, may be found, for example, in U.S. Pat. Nos. 5,893,333; 5,933,621; 5,933,621; and 5,103,663, all of which are incorporated herein by reference in their entirety.

[0074] In some embodiments, the prosthetic valve 10 can include a plurality of commissure support elements configured as commissure clasps or clamps 26. In the illustrated configuration, the prosthetic valve includes a commissure clamp 26 disposed at each commissure 24 at spaced radially inward positions of the frame 12 and configured to grip adjacent portions of the two leaflets 22 at each commissure 24. Each clamp 26 can be attached to the actuator 20 as shown. In alternative embodiments, the commissure support elements (such as clamps 26) can be attached to struts 28 of the frame, or alternatively, the commissures 24 can be attached (e.g., sutured) directly to struts of the frame. Further details of the commissure clamps 26 and other techniques for attaching the commissures of the valve assembly to the frame can be found in U.S. Pat. No. 6,399,343.

[0075] Although not shown, the prosthetic valve 10 may also include one or more skirts or sealing members. For example, the prosthetic valve 10 may include an inner skirt attached to the inner surface of the frame. The inner skirt may function as a sealing member to prevent or reduce paravalvular leakage, to secure the leaflets 22 to the frame, and / or to protect the leaflets from damage caused by contact with the frame during crimping and during the operating cycle of the prosthetic valve. The prosthetic valve 10 may further include an outer skirt attached to the outer surface of the frame 12. The outer skirt may function as a sealing member for the prosthetic valve by sealing against the tissue of the native annulus and helping to reduce paravalvular leakage through the prosthetic valve. The inner and outer skirts may be formed from any of a variety of suitable biocompatible materials, including any of a variety of synthetic materials (e.g., PET) or natural tissues (e.g., pericardial tissue). The inner and outer skirts may be attached to the frame using sutures, adhesives, welding, and / or other means for attaching the skirts to the frame.

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

[0077] In the illustrated embodiment, the struts 28 are pivotally coupled to one another 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 at both ends of the strut (see, e.g., opening 114 in FIG. 4) and openings spaced apart along the length of the strut. Respective hinges can be formed where the struts 28 overlap one another via fasteners or pivot members, such as rivets or pins 30, that extend through the openings. The hinges can allow the struts 28 to pivot relative to one another when the frame 12 is radially expanded or compressed, such as during 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., frame struts and fasteners) and then mechanically assembling and connecting the individual components together. In other embodiments, the struts 28 are not coupled to one another at their respective hinges, but are otherwise pivotable or bendable relative to one another to allow radial expansion and contraction of the frame 12. For example, the frame 12 can be formed (e.g., via laser cutting, electroforming, or physical vapor deposition) from a single piece of material (e.g., a metal tube). Further details regarding the construction of the frame and prosthetic valves are described in U.S. Patent Nos. 5,213,633, 5,213,649, 5,213,714, 5,213,725, 5,213,735, 5,213,745, 5,213,755, 5,213,765, 5,213,775, 5,213,785, 5,213,795, 5,213,825, 5,213,975, 5,213,102, and 5,213,102, which are all incorporated herein by reference. Additional examples of expandable prosthetic valves that can be used with the delivery devices disclosed herein are described in U.S. Patent Nos. 5,213,633 and 5,213,795, 5,213,775, 5,213,795, 5,213,102, and 5,213, which are incorporated herein by reference.

[0079] 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. The 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 may generally include an inner member 34, such as an inner tubular member, and an outer member 36 disposed about the inner member 34. The inner member 34 and the outer member 36 may be telescopically and longitudinally movable relative to one another to radially expand and contract the frame 12, as further described in U.S. Patent Nos. 5,399,413, 5,423,631 and 5,596,797, which are incorporated herein by reference. The inner member 34 may be, for example, a rod, cable, wire, or tube. The outer member 36 may be, for example, a tube or sheath having sufficient stiffness to be able to apply a distally directed force to the frame without bending or buckling.

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

[0082] The inner member 34 and the outer member 36 are telescopically telescopic relative to one another between a fully contracted state (corresponding to a fully radially expanded state of the prosthetic valve) and a fully extended state (corresponding to a fully radially compressed state of the prosthetic valve). In the fully extended state, the inner member 34 is fully extended from the outer member 36. In this manner, the push-pull mechanism 32 allows the prosthetic valve to be fully expanded or partially expanded to various diameters and holds the prosthetic valve in a partially or fully expanded state. It should be understood that, so long as the inner and outer members of each actuator are coupled at axially spaced pivot joints of the frame, the inner and outer members 34 and 36 can be coupled to other locations of the frame to effect radial compression and expansion of the frame.

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

[0084] Once coupled to the delivery device, the prosthetic valve 10 can then be radially folded (see, e.g., FIG. 3) and the distal end portion of the delivery device with the radially folded valve can be inserted into the patient. Once 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, allowing the frame 12 to maintain an expanded diameter after the prosthetic valve is released from the delivery device. Further details of the locking mechanisms can be found in U.S. Patent No. 5,399,992.

[0085] FIG. 2 illustrates a medical assembly according to another embodiment. The assembly includes a prosthetic valve 100 and one or more linear actuator assemblies 200 (one shown in FIG. 2) releasably coupled to the prosthetic valve. The prosthetic valve 100 includes a frame 102. The prosthetic valve 100 can include valve structures (e.g., including leaflets) 18 as previously described, as well as inner and / or outer skirts, although for purposes of illustration, these components are omitted. The frame 102 includes a plurality of struts 116 with openings 114 (see FIG. 4 ) formed therein, and pivot members 118 (e.g., pins or rivets) connecting the struts to one another 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] 3-4 show the bare frame 102 (without valve leaflets and other components) of the prosthetic valve 100 to illustrate 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 in the illustrated configuration can be radially expanded by maintaining the first end 104 of the frame 102 in a fixed position while applying an axial force against the second end 106 toward the first end 104. Alternatively, the prosthetic valve 100 can be expanded by applying an axial force against the first end 104 while maintaining the second end 106 in a fixed position, or by applying opposing axial forces to the first end 104 and second end 106, respectively.

[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 radial expansion and compression of the frame 102. FIG. 2 shows the linear actuator assembly 200 in the process of being separated 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 extending coaxially over the actuator member, a support tube or pusher member 206 extending coaxially over the cover tube 204, and a threaded screw 208. The actuator member 202 can be, for example, a rod, cable, or wire. The actuator member 202 is connected at its distal end to the threaded screw 208 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 delivery device handle or other control device (not shown) that a physician or delivery device operator can use to rotate the actuator member 202. Similarly, the proximal end 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 locations, for example, at or adjacent the distal and proximal ends of the frame.

[0088] The screw 208 has an external threaded surface engageable with an internal threaded surface of a sleeve 110 that is attached to the frame 102, such as at the distal end of the frame. When the actuator member 202 is rotated to thread the screw 208 into the sleeve 110, the actuator member 202 is connected to a 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, which can be attached to a 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 diameter of the cover tube 204 and the screw 208 such that when the frame 102 is expanded and the actuator is retracted proximally by a 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 to prevent the support tube 206 from moving distally beyond the stopper 112.

[0090] In operation, prior to implantation into 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 may then be placed in a radially collapsed state and the prosthetic valve and a distal end portion of the delivery device may be inserted into the patient. Once the prosthetic valve 100 is positioned at the desired implantation site, the frame 102 may be radially expanded, as described herein.

[0091] To radially expand the frame 102, the support tube 206 is held tightly against the stopper 112. The actuator member 202 is then pulled proximally through the support tube 206, for example, by pulling on the proximal end of the actuator member 202 or by manipulating a control knob on the handle to move the actuator member 202 proximally. Because the support tube 206 is held against 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. Thus, moving the actuator member 202 proximally results in the distal end of the frame 102 moving proximally, causing the frame 102 to contract axially and expand radially.

[0092] It should be appreciated 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 proximal end of the frame toward the distal end of the frame by simultaneously pushing the support tube 206 distally against the stopper 112 and pulling the actuator member 202 proximally.

[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 disengage the screw 208 from the stopper 112. The actuator member 202 and cover tube 204 can then be retracted proximally through the stopper 112, and the linear actuator assembly 200 (including the actuator member 202, screw 208, cover tube 204, and support tube 206) can be withdrawn from the patient. The cover tube 204 facilitates passage of the screw 208 through the stopper 112. In some embodiments, the cover tube 204 may be omitted. In embodiments having multiple linear actuator assemblies 200, the above 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 US Pat. No. 6,399,633.

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

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

[0097] The inner shaft 310 can define a lumen configured to receive a guidewire. For example, during delivery of an implantable medical device (e.g., a prosthetic heart valve) to a target implantation site using the delivery apparatus 300, the delivery apparatus 300 can be advanced over the 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 prosthetic valve. However, in alternative embodiments, the delivery device 300 can include more or less than three actuator assemblies 306 (e.g., one, two, four, etc.). As shown in FIG. 5, the multiple actuator assemblies 306 can be circumferentially spaced from one another around the circumference of the delivery device 300 and extend axially through the outer shaft 304 from the handle 302 to the prosthetic valve 308.

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

[0100] 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 a patient's lumen to a target implantation site of the prosthetic valve 308. The nose cone 314 can 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 a frame of the prosthetic valve 308. In some embodiments, the actuator assembly 306 of the delivery device 300 can be configured to transmit pushing and / or pulling forces 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 locking units.

[0102] In some embodiments, the outer shaft 304 of the delivery device 300 can be configured as a steerable guide catheter having an adjustable curvature for use in maneuvering the delivery device 300 through a patient's vasculature. In certain embodiments, the outer shaft 304 can include a steerable 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 may be moved (axially and / or rotationally) relative to one another to facilitate delivery and positioning of the prosthetic valve 308 at an implantation site within a patient's body.

[0104] In some embodiments, the distal end portion 312 of the outer shaft 304 can be formed and / or function as a sheath (e.g., capsule) sized and shaped to receive and house the prosthetic valve 308 in a radially compressed state for delivery through the patient's vasculature. Once the prosthetic valve 308 has been advanced to or adjacent to an implantation site, the prosthetic valve 308 can be advanced out of the sheath by advancing the actuator assembly 306 relative to the outer shaft 304, which can then radially expand the prosthetic valve 308. 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 retracting the outer shaft 304 relative to the actuator assembly 306 can be actuated by manipulating a first knob 316 of the handle 302. The first knob 316 can be operably connected to a 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 can be operably connected to a 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] The handle 302 may include additional adjustment knobs, such as a second knob 318 and a third knob 320, as shown in Figure 5. In some embodiments, the second knob 318 is operably coupled to the actuator assembly 306 and may actuate the actuator assembly 306 to adjust the prosthetic valve 308 from an unexpanded (or radially compressed) configuration (shown in Figure 6B, below) to a radially expanded configuration (shown in Figure 6C, below), or vice versa.

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

[0108] 6A-6C, a portion of a delivery device 300 is shown at various stages of a prosthetic valve deployment (e.g., implantation) procedure. As described above with reference to FIG. 5, the delivery device 300 comprises an outer shaft 304 having a distal end portion 312 forming a sheath (e.g., capsule) 322 configured to house a crimped (radially compressed) prosthetic valve 308 during delivery of the prosthetic valve 308 to a target implantation site. The delivery device 300 further comprises an inner shaft 310 having a nose cone 314 attached to a 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 disposed coaxially (radially relative to the central longitudinal axis of the delivery device) between the outer shaft 304 and the inner shaft 310. The intermediate shaft 324 can be configured to house and organize the actuator assemblies 306. For example, the actuator assemblies 306 can be housed within the distal end of the intermediate shaft 324 and extend outwardly from the distal end of the intermediate shaft 324. In some embodiments, each actuator assembly 306 can remain separate from the 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 only two actuator assemblies 306 are shown in FIGS. 6A-6C, the delivery device 300 may include three actuator assemblies 306 positioned around the periphery 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, via the delivery device 300, to a target implantation site.

[0112] 6A, the distal end 326 of the prosthetic valve 308 is disposed adjacent to the proximal end of the nosecone 314. Thus, there may be little or no gap between the nosecone 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 central longitudinal 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 from the sheath 322. FIG. 6B illustrates this exposed (e.g., uncoiled) state in which the prosthetic valve 308 is disposed outside of the sheath 322. In this state, the prosthetic valve 308 is not being actively expanded via the actuator assembly 306. However, because the prosthetic valve 308 is no longer constrained (e.g., held within) the sheath 322, the prosthetic valve 308 can assume a partially expanded diameter D2, which is greater 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 may expand 10% to 20% radially relative to the central longitudinal axis of the valve and delivery device 300. It should be noted that the degree of expansion of the prosthetic valve 308 from a compressed minimum diameter D1 (FIG. 6A) to a partially expanded diameter D2 (FIG. 6B) may be exaggerated in FIG. 6B for illustrative purposes. The diametric expansion 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 illustrates the prosthetic valve 308 after being actively expanded via actuation of the actuator assembly 306. For example, from FIG. 6B to FIG. 6C, a user can actuate the actuator assembly 306 (e.g., via the second knob 318 of the handle 302 shown in FIG. 5) to radially expand the prosthetic valve 308. As a result, the prosthetic valve 308 can be radially expanded to an 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] In the partially expanded state, as shown in the example of FIG. 6B, a gap formed between the distal end of the valve and the nosecone may create a discontinuity. If repositioning of the prosthetic valve at the target implantation site is required at this stage, this discontinuity may make it difficult to advance the prosthetic valve in a distal direction, especially if the user is attempting to repass the native aortic annulus. Furthermore, in some embodiments, it may be necessary to reposition the prosthetic valve even after it has been partially or fully expanded. Repositioning or repassing the prosthetic valve may require at least partial compression of the valve, followed by repositioning (e.g., distally or proximally), and re-expansion at the new location. The gap between the nosecone and the distal end of the prosthetic valve may make repositioning the valve difficult. For example, the gap formed may make it difficult to reposition the valve in a distal and / or proximal direction without the valve contacting the patient's anatomy.

[0116] In some cases, the actuator assembly 306 may be configured to prevent any expansion of the prosthetic valve 308 after it has been advanced from the sheath 322, but before the actuator assembly is used to actively expand the prosthetic valve. In other words, the prosthetic valve 308 may have a diameter equal to D1 after it has been advanced from the sheath 322. If there is a gap between the prosthetic valve 308 and the nosecone 314 when the prosthetic valve is retained in the sheath 322, that gap will typically remain after the prosthetic valve has been advanced from the sheath 322. In such cases, the gap may make it difficult for the native valve leaflets to repass.

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

[0118] It may therefore be desirable to reduce the gap that forms between a fully compressed, or partially or fully expanded, prosthetic valve and the nose cone of the delivery device, allowing the valve to be more easily repositioned without damaging the patient's anatomy. As one example, by creating continuity (e.g., a continuous transition) between the nose cone and the distal end of the prosthetic valve, even after partial or full expansion of the prosthetic valve, this gap can be reduced (and in some cases eliminated), thereby allowing the prosthetic valve to be more easily repositioned at the target implantation site.

[0119] For example, in some embodiments, a delivery device (e.g., apparatus) configured to deliver a prosthetic medical device, such as a prosthetic heart valve, to a target implantation site can include a transition element configured to be positioned between a nose cone of the delivery device and the prosthetic medical device after deployment from within a sheath of the outer shaft of the delivery device. In some embodiments, the transition element can be a balloon, as shown in Figures 7A-7D. In some such embodiments, the balloon can be an inflatable balloon that is contracted and positioned 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 deployment of the device from the sheath (if repassage or repositioning is required; otherwise, the balloon does not need to be inflated). In other such embodiments, the balloon can be pre-filled (e.g., pre-inflated) and compressed within the outer shaft (or within another tube or shaft of the delivery apparatus) during the delivery process, and then passively expanded between the nose cone and the device after deployment of the device from the sheath.

[0120] In other embodiments, the transition element may be a compressible element, such as a sponge, as shown in Figures 8A-8C. In yet other embodiments, the transition element may be a mechanical element with an expandable frame, as shown in Figures 9A-9C. In this manner, the transition element may form a continuous transition between the nosecone and the prosthetic medical device after being deployed from the sheath.

[0121] 7A-9C show embodiments of a delivery device (e.g., apparatus) 400 with a transition element 402 configured to be positioned between a nose cone 414 of the delivery device 400 and a partially expanded prosthetic valve (e.g., prosthetic heart valve) 408 after deployment of the delivery device 400 from a sheath 422. These embodiments can also be used when a gap exists between a fully compressed prosthetic valve and the nose cone 414 after deployment from the sheath 422 (i.e., when the prosthetic valve has a diameter D1 after deployment from the sheath). Similar to the delivery apparatus 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 house the prosthetic valve 408 in a radially compressed (e.g., crimped) configuration during delivery of the prosthetic valve 408 to the target implantation site.

[0122] The delivery device 400 further comprises an inner shaft 410 having a nosecone 414 attached to a 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 coaxially disposed between the outer shaft 404 and the inner shaft 410. The intermediate shaft 424 can be configured to house and organize one or more actuator assemblies (e.g., actuators) 406. For example, the actuator assemblies 406 can be housed within a distal end of the intermediate shaft 424 and extend outwardly from the distal end of the intermediate shaft 424.

[0124] The prosthetic valve 408 comprises a frame having a proximal end 416 and a distal end 426, the distal end 426 being disposed opposite the proximal end 416 in the direction of a central longitudinal 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 proximate to the proximal end 420 of the nosecone (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] 7A-9C is a mechanically expandable valve, in alternative embodiments, the prosthetic valve 408 may be a balloon-expandable valve or a self-expanding valve. As such, the delivery device 400 may not include the actuator assembly 406, and may instead include an inflatable balloon, sheath, or no additional components for expanding the prosthetic valve 408, provided that the prosthetic valve is entirely self-expanding.

[0126] In some embodiments, as shown in Figures 7A-7D, the transition element 402 is a balloon 436. As shown in Figure 7A, the prosthetic valve 408 is held in a radially compressed (e.g., crimped) state within a sheath 422 of the outer shaft 404. The balloon 436 is also disposed within the outer shaft 404. In some embodiments, as shown in Figure 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 an axial direction relative to the central longitudinal 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 positioned adjacent to the nose cone 414, and after retraction of the sheath 422, the balloon 436 may be advanced proximally through the interior of the no-longer-compressed prosthetic valve 408 and into a 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 be inflated from a contracted state (as shown in FIG. 7A) to an inflated state (as shown in FIG. 7B, described further below). For example, the balloon 436 may be held in a contracted (e.g., uninflated) state within the sheath 422 when the prosthetic valve 408 is also held (in a radially compressed state) within the sheath 422, as shown in FIG. 7A. After the prosthetic valve 408 is deployed from the sheath 422 (e.g., via axially retracting the outer shaft 404 proximally and / or axially advancing the valve 408 distally from the outer shaft 404) and exposed (e.g., not surrounded by the sheath 422), the prosthetic valve 408 can assume a partially expanded state (e.g., not actively expanded by the actuator assembly) having a partially expanded diameter (as described above with reference to FIG. 6B) that is larger than its radially compressed diameter when disposed within the sheath 422. 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 the balloon 436. For example, a balloon catheter may extend through the midshaft 424 and / or the inner shaft 410 and be fluidly coupled to the balloon 436. In another embodiment, a lumen of the inner shaft 410 may be used to deliver an inflation fluid (e.g., saline) to the balloon 436 through one or more ports or openings disposed along the inner shaft 410 in a region of the inner shaft 410 disposed within the balloon 436.

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

[0130] The balloon 436 may be inflated an amount that provides this continuous transition between the proximal end 420 of the nosecone 414 and the distal end 426 of the prosthetic valve 408 .

[0131] In some embodiments, the balloon 436 can be a compliant balloon formed from an elastic material (e.g., polyurethane or silicone). The compliant 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-compliant balloon formed from a material that is relatively less elastic than the material used for compliant balloons (e.g., Pebax or high durometer polyurethane). Like a compliant balloon, a semi-compliant 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 stretch or expand to the extent that a compliant balloon can.

[0132] In yet other embodiments, the balloon 436 can be a non-compliant balloon formed from a non-elastic material or a material with slight elasticity (e.g., polyester or nylon). A non-compliant 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 will be used.

[0133] 7B, the inflated balloon 436 can facilitate repositioning of the prosthetic valve 408, especially in a distal direction, once the target implantation site is reached, if such repositioning is required. For example, the continuous transition between the nose cone 414 and the prosthetic valve 408 provided by the inflated balloon 436 can enhance maneuverability of the prosthetic valve 408 through the delivery device 400 without the prosthetic valve contacting and / or damaging the patient's anatomy at the target implantation site.

[0134] Once the prosthetic valve 408 has been actively expanded (e.g., as shown in FIG. 6C) and implanted at the target implantation site, the balloon 436 may be deflated, for example to a deflated state as shown in FIG. 7A, and then pulled back through the lumen of the expanded prosthetic valve 408 and into the sheath 422. In this manner, the balloon 436 may be deflated to reduce its diameter for easier removal through the patient's vasculature from the target implantation site without dislodging the implanted valve.

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

[0136] In other embodiments, as shown in Figures 7C and 7D, balloon 436 may be a pre-inflated (or pre-filled) balloon, which may be configured to be actively expanded or passively expanded from a compressed state (shown in Figure 7A) to an expanded state (shown in Figures 7C-7D), 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 (e.g., a hydrogel, which may be in the form of hydrogel beads, etc.) to an 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. The sheath 422 may then be retracted away from the prosthetic valve 408, exposing and deploying the valve, allowing the pre-filled balloon 436 to passively expand (by an expansion amount based on its pre-filled size or diameter). For example, a pre-filled (e.g., pre-inflated) balloon may assume its pre-inflated size (e.g., diameter) when in a (radially) expanded state.

[0138] In some embodiments, the shape of the balloon (whether pre-filled or inflated) can be altered by the user by moving the proximal and distal ends of the balloon relative to one another. For example, as shown in FIGS. 7C and 7D, the pre-filled balloon may be attached at its proximal end (e.g., the end closest to the prosthetic valve 408) to a pulling member 434, such as a cable or shaft, or at its distal end to the nosecone 414 and / or inner shaft 410. The pulling member 434 may be configured to apply a pulling force (e.g., axially in the proximal direction) or a pushing force (e.g., axially in the distal direction) to the proximal end of the balloon 436. Moving the pulling member 434 axially relative to the inner shaft 410, or vice versa, is effective to adjust the length and diameter of the balloon 436. In particular, retracting the pulling member 434 proximally and / or advancing the inner shaft 410 distally is effective to increase the length and decrease the diameter of the balloon 436 (FIG. 7D) (effectively radially compressing the balloon), while advancing the pulling member 434 distally and / or retracting the inner shaft 410 proximally is effective to decrease the length and increase the diameter of the balloon 436 (FIG. 7C) (effectively radially expanding the balloon). The balloon can be returned into the sheath 422 at the end of the procedure by retracting both the inner shaft 410 and the pulling member 434 proximally relative to the sheath 422.

[0139] In some cases, as shown in Figure 7C, the balloon 436 may assume an expanded diameter 428 that is larger than the desired outer diameter of the balloon 436. This may 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 one another, as shown by a first length 430 that represents the (axial) length of the balloon 436. In these cases, it may be possible to extend the length of the balloon 436 from the first length 430 (shown in Figure 7C) to a longer second length 432, as shown in Figure 7D.

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

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

[0142] Additionally, in embodiments of a pre-filled (non-actively inflatable) balloon 436, the length and fill volume of the balloon may further be selected to allow for retraction of the balloon through the lumen of the 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, the balloon 436 may be pre-filled with a liquid (e.g., saline). The balloon may be radially compressed by retracting the pulling member 434 proximally and / or advancing the inner shaft 410 distally to reduce the diameter of the balloon 436 until the diameter of the balloon 436 is equal to or less than D1 and can be stored within the sheath 422 during delivery of the prosthetic valve. At the implantation site, the prosthetic valve 408 and balloon 436 may be deployed from the sheath 422. The user may then adjust the size of the balloon 436 to create a smooth transition between the prosthetic valve and the balloon, as depicted in FIG. 7C.

[0144] A pre-filled balloon does not require an inflation / deflation catheter, thereby simplifying the overall construction of the delivery device 400. In an alternative embodiment, the balloon may be pre-filled, but may 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 Figures 7C and 7D can be used to adjust the length of an inflatable balloon either before or after the balloon is inflated with an inflation medium.

[0146] In this manner, the balloon of the delivery device (either actively inflatable or pre-inflated) can be configured to be positioned between the nosecone and the prosthetic valve after the prosthetic valve is unspooled from the outer shaft of the delivery apparatus, thereby providing a continuous transition and bridging the gap created between the nosecone and the uncompressed prosthetic valve, such that 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] 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 upon application of a compressive force and that is allowed to return (e.g., spring back) to its rest or uncompressed size after the compressive force is removed.

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

[0149] 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 direction of the central longitudinal axis 418 in a space between the proximal end 420 of the nosecone 414 and the distal end 426 of the prosthetic valve 408. In this manner, the compressible element 440 may be disposed directly adjacent each of the nosecone 414 and the prosthetic valve 408. The inner shaft 410 may extend through the compressible element 440. The compressible element 440 may be attached to the nosecone 414 and / or the inner shaft 410.

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

[0151] 8B, when the sheath 422 is partially pulled away from the nosecone 414 in a proximal direction 444, a distal portion of the compressible element 440 (e.g., the portion disposed adjacent the nosecone 414) is exposed and is exposed to the external environment (outside the sheath 422). As a result, the distal portion of the compressible element 440 that is no longer disposed within the sheath 422 may expand to a diameter greater than the first diameter 442. However, the portion that remains confined within the sheath 422 (e.g., the proximal portion) maintains its compressed first diameter 442.

[0152] In Figure 8C, the sheath 422 has been pulled back in a proximal direction 444 to further expose and uncover the entire 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 may also be a non-actively expanded state. Thus, the diameter of the prosthetic valve 408 may be larger in its non-actively expanded state than its radially compressed diameter shown in Figure 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, uncompressed state) having a second diameter 450, as shown in FIG. 8C. The second diameter 450 is greater 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 nosecone 414.

[0154] In this manner, by virtue of its compressible nature, compressible element 440 is configured to passively (e.g., without active actuation from an external actuation source) expand from its compressed state to an expanded, uncompressed state upon removal from within sheath 422. This is because the inner wall of sheath 422 no longer exerts an inward compressive force against the outer surface of compressible element 440.

[0155] 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 nosecone 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 the second diameter 450 at the mid-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 at the mid-portion to the distal end 426 of the prosthetic valve 408.

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

[0158] In some embodiments, as shown in FIG. 8D , the proximal tapered region 452 is disposed within the prosthetic valve 408 and extends partially into the interior of the prosthetic valve 408 from the distal end 426 of the prosthetic valve 408. This taper allows the distal end of the prosthetic valve to partially overlap the compressible element 440, ensuring a smooth transition between the prosthetic valve 408 and the compressible element 440. Additionally, this taper allows the compressible element 440 to be compressed against either the at least partially expanded frame of the prosthetic valve 408 or the distal lip of the sheath 422, 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 tapered region 452 may be more easily retracted through the prosthetic 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 in which the compressible element has a proximal tapered region 452, the proximal-most end 456) may be attached to a pulling member (not shown in FIGS. 8A-8D ) such as a cable or shaft (alternatively or in addition to being attached to the inner shaft 410 or nose cone 414) configured to apply a pulling force in the proximal direction 444 to retract the compressible element 440 closer to the prosthetic valve 408 or away from the implantation site at the end of the procedure.

[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) during removal from the implantation site at the end of the implantation procedure and cannot radially expand to interfere with or displace the implanted prosthetic valve 408.

[0161] In this manner, a compressible element of the delivery device (e.g., a compressible foam or sponge) may be configured to be disposed between the nosecone and the prosthetic valve after the prosthetic valve is unspooled from the outer shaft of the delivery device, thereby providing a continuous transition between the nosecone and the partially expanded prosthetic valve such that 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] 9A-9C, the transition element 402 is an expandable mechanical element 460 that includes 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 the expanded state, the mechanical element 460 is configured to provide an axially continuous transition between the nosecone 414 and the frame of the prosthetic valve 408.

[0163] 9A-9C, the expandable frame 462 can include a number of arms 464 attached to a proximal region of the nosecone 414. In some embodiments, a distal end 468 of each of the arms 464 can be coupled to the proximal end 420 of the nosecone 414.

[0164] In some embodiments, a distal end 468 of each of the arms 464 may be coupled to the proximal end 420 of the nosecone 414 via a hinged connection 466. As such, 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 axially proximally from its distal end 468 to a proximal end 470 of the arm 464, toward the prosthetic 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 thus is configured to move freely from a compressed state to an expanded state.

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

[0167] 9A , the frame 462 may be held in its radially compressed state within the sheath 422 when the sheath 422 encircles both the prosthetic valve 408 and the frame mechanical element 460, with its arms 464 spring-loaded against the inner wall of the sheath 422. For example, the frame 462 may be held in its radially compressed state by an inward compressive force from the surrounding inner wall of the sheath 422.

[0168] The sheath 422 is then removed to expose the frame 462 (eg, retracted proximally away from the nosecone 414), causing the frame 462 to assume an expanded configuration in which the diameter tapers from the prosthetic valve 408 to the nosecone 414.

[0169] For example, as shown in FIGURE 9B, when the sheath 422 is moved axially away from the frame 462 to expose the frame 462 and the prosthetic valve 408, the proximal end 470 of each of the arms 464 may be forced radially outward (relative to the central longitudinal axis) due to a preloaded spring force. The distal end 468 of each of the arms 464 remains fixed to the nosecone 414, but each arm may pivot about its corresponding hinged connection 466 to the nosecone 414 to allow the proximal end 470 of each arm 464 to expand radially outward to an expanded diameter 474 (shown in FIGURE 9B) that is larger than the compressed diameter 476 of the frame 462 (shown in FIGURE 9A).

[0170] 9B, in its expanded state, the frame 462 tapers toward the proximal end 420 of the nosecone 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 prosthetic valve 408 and the distal end 468 of each arm 464 of the frame 462 contacts the proximal end 420 of the nosecone 414.

[0171] In this manner, mechanical element 460 extends between and forms a continuous transition between nosecone 414 and prosthetic valve 408 after prosthetic valve 408 has been deployed from within sheath 422 and assumes an at least partially expanded configuration (as shown in FIG. 9B). Additionally, mechanical element 460 fills a gap that may otherwise be created between the at least partially expanded prosthetic valve 408 and nosecone 414, as described above with reference to FIGS. 6B-6C.

[0172] 9C, the mechanical element 460 can further comprise a compression mechanism 478 configured to recompress the frame 462 to its compressed state to facilitate retraction of the frame 462 from the implantation site, through the lumen of the expanded prosthetic valve 408, and into the sheath 422 once the implantation procedure is complete. As a result, the mechanical element 460 and nose cone 414 can be retracted proximally, away from the implantation site, and through the lumen of the prosthetic valve without disturbing or dislodging the implanted prosthetic valve.

[0173] 9C shows mechanical element 460 without cover 472 surrounding frame 462 for purposes of illustration. Mechanical element 460 may or may not include cover 472 in different embodiments. In embodiments in which mechanical element 460 includes cover 472, compression mechanism 478 may be configured to surround cover 472 and compress cover 472 and frame 462 together into a compressed state.

[0174] 9C, in some embodiments, the compression mechanism 478 comprises an adjustable loop 480 (e.g., a loop of wire or suture) that wraps or encircles the arm 464 of the frame 462, and an actuation member 482 (e.g., a wire or suture) configured to reduce the size of the loop and compress the frame 462. Pulling the actuation member 482 proximally (at the handle of the delivery device) is effective to reduce the diameter of the loop, thereby radially compressing the mechanical element 460. Further details of such compression mechanisms can be found in U.S. Patent Application Publication No. 2007 / 0139999, the entire contents of which are incorporated herein by reference.

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

[0176] Figure 10 illustrates 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 Figure 1, the prosthetic valve 100 of Figures 2-4, the prosthetic valve 308 of Figures 5-6C, and the prosthetic valve 408 of Figures 7A-9C.

[0177] At 1002, method 1000 includes advancing a delivery device of a transcatheter delivery system (e.g., delivery device 300 of FIGS. 5-6C and / or 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 forming a sheath surrounding a radially compressed prosthetic valve proximate a proximal end of a nose cone of the delivery device. An example of a sheath of the outer shaft of the delivery device surrounding a radially compressed prosthetic valve is shown in FIGS. 6A, 7A, 8A, and 9A, as described above.

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

[0179] At 1006, if repositioning (e.g., repassage of the native valve) is required, method 1000 includes expanding a transition element of the delivery device in a space formed between the proximal end of the nosecone and the distal end of the prosthetic valve in the partially expanded or 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 expanding the transition element includes inflating the inflatable balloon from a deflated state to an inflated state (shown in FIGS. 7A-7B) between the nosecone and the partially expanded (e.g., uncompressed) or fully compressed prosthetic valve.

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

[0181] In yet other embodiments, the transition element is a compressible element including one of a compressible foam and sponge material, and 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), where the compressible element is in its resting state when in the expanded state. In other embodiments, the transition element is a mechanical element including an expandable frame having a distal end coupled to a nosecone, and expanding the transition element includes expanding a 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 place the distal end of the prosthetic valve in contact with or partially overlapping the proximal end of the transition element.

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

[0183] At 1010, the method 1000 includes actively radially expanding the prosthetic valve to a radially expanded state after repositioning the prosthetic valve or after positioning the prosthetic valve (without repositioning). For example, 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, actively expanding the prosthetic valve may include filling an inflatable balloon of a balloon catheter around which the prosthetic valve is mounted to radially expand the prosthetic valve.

[0184] At 1012, the method 1000 includes retracting the nosecone 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 smaller geometry (e.g., diameter) than its 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 nosecone and balloon proximally through the lumen of the prosthetic valve. In another example, if the transition element is a compressible element (e.g., compressible foam or sponge), the method of 1012 may include pulling the nosecone and compressible element proximally through the lumen of the prosthetic valve to passively compress the compressible element (e.g., via pressure against the lumen of the prosthetic valve) to a radially smaller state. In yet another example, if the transition element is a mechanical element having an expandable (and compressible) frame, the method of 1012 may include the step of 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 compressed mechanical element proximally through the lumen of the prosthetic valve.

[0185] In this manner, a more continuous transition between an at least partially expanded or fully compressed prosthetic valve (e.g., after removal from a delivery device sheath) and the nosecone of the delivery device provided by one of the transition elements described herein may allow for easier repositioning of the prosthetic valve at or adjacent to a target implantation site within a patient's body. For example, an at least partially expanded or fully compressed prosthetic valve may be more easily moved distally and / or proximally relative to the target implantation site to reposition the prosthetic valve, and when a transition element is utilized, fully expand to implant the prosthetic valve at the target implantation site without causing damage to the patient's body and / or the prosthetic valve. Additionally, by having a compressible, or actively expandable and compressible, transition element, the transition element may be stored in a compressed state within the outer shaft of the delivery device during manipulation 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 creating a more continuous transition in the space formed between the exposed prosthetic valve and the nosecone. The compressible transition element can then be re-compressed through the lumen of the expanded prosthetic valve prior to removing the delivery device from the implantation site, thereby allowing for easier removal without disturbing or dislodging the implanted prosthetic valve.

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

[0187] For purposes of this specification, certain aspects, advantages, and novel features of the disclosed embodiments are described herein. The disclosed methods, devices, and systems should not be construed as limiting in any way. Rather, the present disclosure is directed to all novel and non-obvious features and aspects of the various disclosed embodiments, alone and in various combinations and subcombinations with each other. The methods, devices, and systems are not limited to any particular aspect or feature, or combination thereof, and the disclosed embodiments do not require that any one or more particular advantages exist or problems be solved. The technology of any example can be combined with the technology described in any one or more of the other examples. In view of the many possible embodiments to which the principles of the disclosed technology may be applied, it should be recognized that the illustrated embodiments are merely preferred examples and should not be considered as limiting the scope of the disclosed technology.

[0188] Although some operations of the disclosed embodiments are described in a particular order for convenient presentation, it should be understood that such description encompasses rearrangement, unless a particular order is required by specific language set forth below. For example, operations described sequentially may be rearranged or performed simultaneously in some cases. Furthermore, for the sake of brevity, the accompanying drawings may not show various ways in which the disclosed methods can be used in combination with other methods. Furthermore, terms such as "provide" or "achieve" may be used herein to describe the disclosed methods. These terms are high-level abstractions of the operations that are actually performed. The actual operations that correspond to these terms may vary depending on the specific implementation and are readily discernible by those of ordinary skill in the art.

[0189] As used herein, with respect to transcatheter delivery systems, prosthetic heart valves, delivery devices, delivery apparatus, and transition elements, "proximal" refers to the location, direction, or portion of the component closer to the handle of the delivery system that is outside the patient, and "distal" refers to the location, direction, or portion of the component further from the handle (further into the patient). The terms "longitudinal" and "axial" refer to axes extending in the proximal and distal directions, unless expressly defined otherwise.

[0190] As used in this specification and claims, the singular forms "a," "an," and "the" include the plural unless the context clearly dictates otherwise. Additionally, the term "includes" means "comprises." Additionally, 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 coupled or associated items unless specifically stated to the contrary.

[0191] Directions and other relative designations (e.g., inside, outside, above, below, etc.) may be used to facilitate discussion of the figures and principles herein, but are not intended to be limiting. For example, specific terms such as "inside," "outside," "up," "down," "internal," "external," etc. may be used. Such terms are used to provide some clarity of explanation, where applicable, when dealing with relative relationships, particularly with respect to the illustrated embodiments. However, such terms do not imply absolute relationships, positions, and / or directions. For example, with respect to an object, if the object is turned over, the "upper" part may become the "lower" part. 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] In view of the many possible embodiments to which the principles of the disclosed invention may be applied, it should be recognized that the illustrated embodiments are merely preferred examples of the invention and should not be considered as limiting the scope of the invention, which is rather defined by the following claims, and we therefore claim as our invention all that comes within the scope and spirit of these claims. [Explanation of symbols]

[0193] 10 Artificial valves 12 Frames 14 End, inlet end 16 End, outflow end 18 Valve Structure 20 Actuator 22 Valve leaflets 24 Commissures 26 Clamp 28 Strut 30 pin 32 Push-pull mechanism 34 Inner member 34a Distal end portion 36 Outer member 38 Top 40 Locking mechanism 42 Inner member 100 Artificial valve 102 Frames 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 apparatus, delivery device 302 Handle 304 Outer Shaft 306 Actuator Assembly 308 Artificial Valves 310 Inner Shaft 312 Distal end section 314 Nosecone 316 Nobu 318 Nobu 320 Nobu 322 Sheath 324 Intermediate shaft 326 Distal end 400 Delivery Device 402 Transitional Elements 404 Outer Shaft 406 Actuator Assembly 408 Artificial Valves 410 Inner Shaft 412 Distal end section 414 Nosecone 416 Proximal end 418 Longitudinal central axis 420 Proximal end 422 Sheath 424 Intermediate shaft 426 Distal end 428 Expanded Diameter 434 Tension member 436 Balloon 438 Proximal end 439 Distal end 440 elements 444 Proximal 446 Proximal end 448 Distal end 452 Proximal Taper Region 456 End 460 Mechanical elements 462 frames 463 Frames 464 Arm 466 hinged connection 468 Distal end 470 Proximal end 472 Cover 478 Compression Mechanism 480 Loops 482 Actuating member D1 Minimum diameter D2 Partially expanded diameter D3 Expanded diameter

Claims

1. A mechanically expandable prosthetic valve; A delivery device. An assembly comprising: The delivery device comprises: an outer shaft having a distal end portion forming a sheath configured to surround the prosthetic valve in a radially compressed configuration; an inner shaft, the inner shaft being disposed within the outer shaft and including a nosecone disposed at a distal end of the inner shaft, the nosecone disposed distally of the outer shaft at the distal end portion of the outer shaft; an expandable transition element configured to expand from an unexpanded state within the outer shaft to an expanded state outside the outer shaft, where in the expanded state the transition element forms a continuous transition from the nosecone to the prosthetic valve as the sheath moves away from the nosecone to expose the prosthetic valve; Equipped with The assembly, wherein the transition element is a balloon.

2. The assembly of claim 1 , wherein the delivery device further comprises at least one actuator assembly disposed within the outer shaft and releasably coupled to the prosthetic valve.

3. 3. The assembly of claim 1 or 2, wherein the balloon is an inflatable balloon that can be expanded from a contracted state prior to removal of the prosthetic valve from the sheath to an expanded state after removal of the prosthetic valve from the sheath.

4. 4. The assembly of claim 3, wherein when the balloon is in the deflated state, the balloon is disposed within the sheath in the radially compressed configuration between the nosecone and the distal end of the prosthetic valve.

5. 5. The assembly of claim 3 or 4, wherein when the balloon is in the inflated state, the balloon is disposed outside the outer shaft, between the nosecone and the distal end of the prosthetic valve.

6. 6. The assembly of claim 3, wherein the balloon is a compliant balloon formed from an elastic material and configured to be inflated to a desired size within a range of possible sizes based on the size of the prosthetic valve.

7. 6. The assembly of claim 3, wherein the balloon is a semi-compliant balloon comprising Pebax.

8. 6. The assembly of claim 3, wherein the balloon is a non-compliant 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 prosthetic valve.

9. 3. The assembly of claim 1 or 2, wherein the balloon is a pre-filled balloon with material for expansion 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.

10. 10. The assembly of claim 1, wherein in the expanded state, a proximal end of the transition element contacts a distal end of the prosthetic valve and a distal end of the transition element contacts a proximal end of the nosecone.

11. The assembly of claim 1 , wherein a distal end of the transition element is attached to a proximal end of the nosecone.

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