Transcatheter devices

Abstract

Transcatheter devices comprise a cylindrical base extending along an elongated axis. The transcatheter devices comprise a spindle circumscribing an outer circumferential surface of the cylindrical base and rotatably coupled to the cylindrical base. The spindle is configured to rotate about the elongated axis relative to the cylindrical base. The transcatheter devices further comprise a friction feature associated with the cylindrical base and the spindle. The friction feature is configured to increase a rotational resistance between the spindle and the cylindrical base.

Description

TRANSCATHETER DEVICESCROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 675,888, filed July 26, 2024, the entire content of which is incorporated herein by reference.FIELD

[0002] The present disclosure relates generally to transcatheter devices, and more particularly, to transcatheter devices including a friction feature associated with a cylindrical base and a spindle.BACKGROUND

[0003] A human heart includes four heart valves that determine the pathway of blood flow through the heart: the mitral valve, the tricuspid valve, the aortic valve, and the pulmonary valve. The mitral and tricuspid valves are atrio-ventricular valves, which are between the atria and the ventricles, while the aortic and pulmonary valves are semilunar valves, which are in the arteries leaving the heart. Ideally, native leaflets of a heart valve move apart from each other when the valve is in an open position, and meet or “coapt” when the valve is in a closed position. Problems that may develop with valves include stenosis in which a valve does not open properly, and / or insufficiency or regurgitation in which a valve does not close properly. Stenosis and insufficiency may occur concomitantly in the same valve. The effects of valvular dysfunction vary, with regurgitation or backflow typically having relatively severe physiological consequences to the patient.

[0004] Diseased or otherwise deficient heart valves can be repaired or replaced using a variety of different types of heart valve surgeries. One conventional technique involves an open-heart surgical approach that is conducted under general anesthesia, during which the heart is stopped and blood flow is controlled by a heart-lung bypass machine.

[0005] More recently, minimally invasive approaches have been developed to facilitate catheter-based implantation of a prosthetic heart valve or prosthesis on the beating heart, intending to obviate the need for the use of classical sternotomy and cardiopulmonary bypass. In general terms, an expandable prosthetic valve is compressed about or within a catheter, inserted inside a body lumen of the patient, such as the femoral artery, anddelivered to a desired location in the heart. In catheter-based implantations of a prosthetic heart valve or prosthesis it is important that the heart valve is accurately located relative to the native annulus prior to full deployment to prevent serious complications, such as for example, where the prosthetic heart valve or prosthesis leaks or dislodges from the native heart valve implantation site.

[0006] In light of the above, a need exists for a transcatheter device that can help during catheter-based implantation of prosthetic heart valves.SUMMARY

[0007] The following presents a simplified summary of the disclosure to provide a basic understanding of some aspects described in the detailed description.

[0008] Features of the present disclosure provide a transcatheter device having a friction feature associated with a cylindrical base and a spindle where the spindle can rotate relative to the cylindrical base. Providing a transcatheter device with the friction feature and the spindle that can rotate relative to the cylindrical base can allow a clinician to replace a defective heart valve while preventing or minimizing a prosthetic heart valve from becoming stuck within the transcatheter device.

[0009] In aspects, transcatheter devices comprise a cylindrical base extending along an elongated axis. The transcatheter devices comprise a spindle circumscribing an outer circumferential surface of the cylindrical base and rotatably coupled to the cylindrical base. The spindle is configured to rotate about the elongated axis relative to the cylindrical base. The transcatheter devices further comprise a friction feature associated with the cylindrical base and the spindle. The friction feature is configured to increase a rotational resistance between the spindle and the cylindrical base.

[0010] Additional features and advantages of the aspects disclosed herein will be set forth in the detailed description that follows, and in part will be clear to those skilled in the art from that description or recognized by practicing the aspects described herein, including the detailed description which follows, the claims, as well as the appended drawings. It is to be understood that both the foregoing general description and the following detailed description present aspects intended to provide an overview or framework for understanding the nature and character of the aspects disclosed herein. The accompanying drawings are included to provide further understanding and are incorporated into andconstitute a part of this specification. The drawings illustrate various aspects of the disclosure, and together with the description explain the principles and operations thereof.BRIEF DESCRIPTION OF THE DRAWINGS

[0011] These and other features, aspects and advantages are better understood when the following detailed description is read with reference to the accompanying drawings, in which:

[0012] FIG. 1 is a schematic view of an exemplary transcatheter device in accordance with aspects of the present disclosure;

[0013] FIG. 2 is a side schematic view of an exemplary prosthetic heart valve that can be utilized with the transcatheter device of FIG. 1 in accordance with aspects of the present disclosure;

[0014] FIG. 2B is a top schematic view of the exemplary prosthetic heart valve of FIG. 2 illustrating leaflets of the prosthetic heart valve;

[0015] FIG. 3 is a schematic cross-sectional view of the transcatheter device taken along line 3-3 of FIG. 1 in accordance with aspects of the present disclosure;

[0016] FIG. 4 is a side schematic view of an exemplary spindle of the transcatheter device of FIG. 3 in accordance with aspects of the present disclosure;

[0017] FIG. 5 is a schematic cross-sectional view of the spindle taken along line 5-5 of FIG. 4;

[0018] FIG. 6 is a schematic cross-sectional view of another embodiment of the transcatheter device taken along line 3-3 of FIG. 1 in accordance with aspects of the present disclosure;

[0019] FIG. 7 is a side schematic view of an exemplary spindle of the transcatheter device of FIG. 6 in accordance with aspects of the present disclosure;

[0020] FIG. 8 is a schematic cross-sectional view of the spindle taken along line 8-8 of FIG. 7;

[0021] FIG. 9 is a schematic cross-sectional view of the spindle taken along line 9-9 of FIG. 7;

[0022] FIGS. 10-13 are schematic side view of various additional embodiments of a spindle of the transcatheter device of FIGS. 3 and 6 in accordance with aspects of the disclosure;

[0023] FIG. 14 is a schematic cross-sectional view of the additional embodiments of the spindles taken along line 14-14 of FIGS. 10-13, illustrating similar features of the additional embodiments of the spindles in accordance with aspects of the present disclosure;

[0024] FIG. 15 is a schematic cross-sectional view of any one of the embodiments of the spindles taken along line 15-15 of FIGS. 4, 7, and 10-13, illustrating similar features of any one of the embodiments of the spindles in accordance with aspects of the present disclosure;

[0025] FIG. 16 is a schematic enlarged view taken at view 16 of FIG. 14, illustrating vectors defining a sloped surface of the embodiments of the spindles of FIGS. 10-13 in accordance with aspects of the present disclosure;

[0026] FIG. 17 is a schematic cross sectional of the embodiments of the spindles taken along line 17-17 of FIGS. 10-13, illustrating the sloped surface in accordance with aspects of the present disclosure; and

[0027] FIG. 18 is a schematic exploded view of an embodiment of the transcatheter device of FIGS. 3 and 6 in accordance with aspects of the disclosure.DETAILED DESCRIPTION

[0028] Aspects will now be described more fully hereinafter with reference to the accompanying drawings in which example aspects are shown. Whenever possible, the same reference numerals are used throughout the drawings to refer to the same or like parts. However, this disclosure may be embodied in many different forms and should not be construed as limited to the aspects set forth herein.

[0029] As used herein, the term “about” means that amounts, sizes, formulations, parameters, and other quantities and characteristics are not, and need not be, exact, but may be approximate and / or larger or smaller, as desired, reflecting tolerances, conversion factors, rounding off, measurement error and the like, and other factors known to those of skill in the art.

[0030] Ranges can be expressed herein as from “about” one value, and / or to “about” another value. When such a range is expressed, aspects include from the one value to the other value. Similarly, when values are expressed as approximations by use of the antecedent “about,” it will be understood that the value forms another aspect. It will befurther understood that the endpoints of each of the ranges are significant both in relation to the other endpoint, and independently of the other endpoint.

[0031] Directional terms as used herein - for example up, down, right, left, front, back, top, bottom, upper, lower, etc. - are made only with reference to the figures as drawn and are not intended to imply absolute orientation.

[0032] Unless otherwise expressly stated, it is in no way intended that any methods set forth herein be construed as requiring that its steps be performed in a specific order, nor that with any apparatus, specific orientations be required. Accordingly, where a method claim does not actually recite an order to be followed by its steps, or that any apparatus claim does not actually recite an order or orientation to individual components, or it is not otherwise specifically stated in the claims or description that the steps are to be limited to a specific order, or that a specific order or orientation to components of an apparatus is not recited, it is in no way intended that an order or orientation be inferred in any respect.This holds for any possible non-express basis for interpretation, including matters of logic relative to arrangement of steps, operational flow, order of components, or orientation of components; plain meaning derived from grammatical organization or punctuation, and; the number or type of aspects described in the specification.

[0033] As used herein, the singular forms "a," "an," and "the" include plural references unless the context clearly dictates otherwise. Thus, for example, reference to “a” component includes aspects having two or more such components, unless the context clearly indicates otherwise.

[0034] The word “exemplary,” “example,” or various forms thereof are used herein to mean serving as an example, instance, or illustration. Any aspect or design described herein as “exemplary” or as an “example” should not be construed as preferred or advantageous over other aspects or designs. Furthermore, examples are provided solely for purposes of clarity and understanding and are not meant to limit or restrict the disclosed subject matter or relevant portions of this disclosure in any manner. It can be appreciated that a myriad of additional or alternate examples of varying scope could have been presented but have been omitted for purposes of brevity.

[0035] As used herein, the terms “comprising,” “including,” and variations thereof shall be construed as synonymous and open-ended, unless otherwise indicated. A list ofelements following the transitional phrases comprising or including is a non-exclusive list, such that elements in addition to those specifically recited in the list may also be present.

[0036] The terms “substantial,” “substantially,” and variations thereof as used herein are intended to represent that a described feature is equal or approximately equal to a value or description. Moreover, “substantially” is intended to denote that two values are equal or approximately equal. The term “substantially” may denote values within about 10% of each other, for example, within about 5% of each other, or within about 2% of each other.

[0037] Modifications may be made to the instant disclosure without departing from the scope or spirit of the claimed subject matter. Unless specified otherwise, “first,” “second,” or the like are not intended to imply a temporal aspect, a spatial aspect, an ordering, etc. Rather, such terms are merely used as identifiers, names, etc. for features, elements, items, etc. For example, a first end and a second end generally correspond to end A and end B or two different ends.

[0038] Unless otherwise indicated, the terms “distal” and “proximal” are used in the following description with respect to a position or direction relative to the treating clinician. “Distal” and “distally” are positions distant from or in a direction away from the clinician, and “proximal” and “proximally” are positions near or in a direction toward the clinician. In addition, the term “self-expanding” may be used in the following description with reference to one or more valve or stent structures of the prostheses hereof and is intended to convey that the structures are shaped or formed from a material that can be provided with a mechanical memory to return the structure from a compressed or constricted delivery configuration to an expanded deployed configuration or vice versa. Non-exhaustive exemplary self-expanding materials include stainless steel, a pseudoelastic metal such as a nickel titanium alloy or nitinol, various polymers, or a so-called super alloy, which may have a base metal of nickel, cobalt, chromium, or other metal. Mechanical memory may be imparted to a wire or stent structure by thermal treatment to achieve a spring temper in stainless steel, for example, or to set a shape memory in a susceptible metal alloy, such as nitinol. Various polymers that can be made to have shape memory characteristics may also be suitable for use in aspects hereof to include polymers such as polynorborene, trans-polyisoprene, styrene-butadiene, and polyurethane. As well poly U-D lactic copolymer, oligo caprylactone copolymer and poly cyclo-octine can be used separately or in conjunction with other shape memory polymers.

[0039] Diseases associated with heart valves, such as those caused by damage or a defect, can include stenosis and valvular insufficiency or regurgitation. For example, valvular stenosis causes the valve to become narrowed and hardened which can prevent blood flow to a downstream heart chamber from occurring at the proper flow rate and may cause the heart to work harder to pump the blood through the diseased valve. Valvular insufficiency or regurgitation occurs when the valve does not close completely, allowing blood to flow backwards, thereby causing the heart to be less efficient. A diseased or damaged valve, which can be congenital, age-related, drug-induced, or in some instances, caused by infection, can result in an enlarged, thickened heart that loses elasticity and efficiency. Some symptoms of heart valve diseases can include weakness, shortness of breath, dizziness, fainting, palpitations, anemia and edema, and blood clots which can increase the likelihood of stroke or pulmonary embolism. Symptoms can often be severe enough to be debilitating and / or life threatening.

[0040] Heart valve prostheses have been developed for repair and replacement of diseased and / or damaged heart valves. Such heart valve prostheses can be percutaneously delivered and deployed at the site of the diseased heart valve through catheter-based delivery systems. Such heart valve prostheses generally include a frame or stent and a prosthetic valve mounted within the frame. Such heart valve prostheses are delivered in a radially compressed or crimped configuration so that the heart valve prosthesis can be advanced through the patient’s vasculature. Once positioned at the treatment site, the heart valve prosthesis is expanded to engage tissue at the diseased heart valve region to, for instance, hold the heart valve prosthesis in position.

[0041] FIG. 1 shows an exemplary transcatheter device 302, 602 in accordance with the present disclosure. In some aspects, the transcatheter device 302, 602 can comprise a handle device 1802, a sheath 1804, and a distal tip 1806. In aspects, the handle device 1802 can comprise one or more actuators (i.e., one actor, two actuators, etc.) configured to actuate various components of the transcatheter device 302, 602. The handle device 1802 will be discussed in further detail with reference to FIG. 18.

[0042] Turning to FIG. 2 and 2B, an exemplary prosthetic heart valve 200 is shown. The prosthetic heart valve 200 is an example prosthetic heart valve 200 that can be utilized with any one of the features discussed herein with reference to the transcatheter device 302, 602. Accordingly, the exemplary prosthetic heart valve 200 will be utilizedhereinafter in order to described various operations and components of the transcatheter device 302, 602.

[0043] As shown, the prosthetic heart valve 200 can comprise an expandable stent frame 202, and prosthetic heart valve leaflets 204. In some aspects, the expandable stent frame 202 may be a self-expandable stent frame, such as for example, a nitinol self-expanding stent frame, or may be a balloon expandable stent frame. In further aspects, the expandable stent frame 202 can comprise a proximal portion 206 (outflow end) and a distal portion 208 (inflow end). In some aspects, the proximal portion 206 and the distal portion 208 can comprise a larger diameter than an intermediate portion 210 of the expandable stent frame 202. In some aspects, the proximal portion 206 may have a greater diameter, a smaller diameter, or an equal diameter to that of the distal portion 208. In some aspects, the expandable stent frame 202 can comprise a lumen 212 extending through a central axis 214 of the expandable stent frame 202.

[0044] As illustrated in FIG. 2B, in aspects, the prosthetic heart valve leaflets 204 can comprise one or more leaflets, such as for example, two leaflets to emulate a bicuspid valve. In some examples, as shown, the prosthetic heart valve leaflets 204 can comprise three leaflets to emulate a tricuspid valve. For example, the prosthetic heart valve leaflets can comprise a first leaflet 216, a second leaflet 218, and a third leaflet 220. Any other suitable number of leaflets may be utilized.

[0045] In some aspects, the prosthetic heart valve 200 can comprise one or more commissure points 222. The commissure points 222 can be utilized to couple the valve structure (e.g., the prosthetic heart valve leaflets 204) of the prosthetic heart valve 200 to the expandable stent frame 202. In some aspects, the valve structure can be coupled to the expandable stent frame 202 by a stitching pattern, such as for example, by stitching the valve structure to the expandable stent frame 202 at the one or more commissure points 222, such as shown in FIG. 2. Any other suitable means of coupling the valve structure to the expandable stent frame 202 may be utilized.

[0046] In some aspects, the proximal portion 206 of the expandable stent frame 202 can comprise a first plurality of cell structures 224. In further aspects, the distal portion 208 of the expandable stent frame 202 can comprise a second plurality of cell structures 226. As show, the first plurality of cell structures 224 and the second plurality of cell structures 226 can comprise diamond-shaped cell structures. The expandable stent frame 202 ismerely exemplary and any other suitable expandable stent frames may be utilized with the exemplary transcatheter device 302, 602 described herein. Furthermore, the first plurality of cell structures 224 and the second plurality of cell structures 226 should not be limited to diamond-shaped cell structures and should not be limited to the number of cell structures and / or size of the cell structures shown in FIG. 2. Accordingly, more or less suitable cell structures with a variety of different shapes and sizes can be employed with the transcatheter device 302, 602.

[0047] In some aspects, the prosthetic heart valve 200 can comprise a skirt 228 coupled to the expandable stent frame 202. As shown, in some examples, the skirt 228 can be coupled to the distal portion 208 of the expandable stent frame 202 and can be coupled to portions of the intermediate portion 210. For example, the skirt 228 can be coupled to the intermediate portion 210 of the expandable stent frame 202 and extend from the intermediate portion 210 towards the distal portion 208 (e.g., the skirt can extend to any portion of the distal portion 208). In other examples, the skirt 228 can extend along any length of the expandable stent frame 202. For example, the skirt can extend along any length of the expandable stent frame 202 defined between the proximal portion 206 and the distal portion 208 of the expandable stent frame 202. The skirt 228 can be coupled to the expandable stent frame 202 by any suitable coupling means. For example, skirt can be coupled to the expandable stent frame 202 by stitching, such as for example, coupling the skirt to the expandable stent frame 202 by a stitching pattern that extends from the intermediate portion 210 of the expandable stent frame 202, and along the distal portion 208 of the expandable stent frame 202 (i.e., along one or more of the second plurality of cell structures 226).

[0048] In aspects, as illustrated, a distal end 230 of the expandable stent frame 202 can comprise a plurality of crowns 232. For example, the distal end 230 of the expandable stent frame 202 can comprise one crown, two crowns, three crowns, and so on. In aspects, a proximal end 234 of the expandable stent frame 202 can comprise a plurality of crowns 236. For example, the proximal end 234 of the expandable stent frame 202 can comprise one crown, two crowns, three crowns, and so on. In some aspects, at least one crown of the plurality of crowns 236 of the proximal end 234 can comprise a paddle 238. In some aspects, the plurality of crowns 236 can comprise two paddles. In some aspects, any number of paddles can be provided. For example, each crown of the plurality of crowns236 can comprise a paddle. In some aspects, the at least one crown of the plurality of crowns 236 can comprise a stem portion 240 that extends in a direction of the central axis 214 of the expandable stent frame 202 and couples the at least one crown of the plurality of crowns 236 to the paddle 238.

[0049] While the transcatheter device 302, 602 will be referred to hereinafter as being utilized with the exemplary prosthetic heart valve 200, other suitable prosthetic heart valves known in the art may be utilized with the transcatheter device 302, 602.

[0050] Turning to FIGS. 3 and 6, embodiments of the transcatheter device 302, 602 are illustrated. In aspects, the transcatheter device 302, 602 can comprise a cylindrical base 304, 604 extending along an elongated axis 306. In some aspects, the cylindrical base 304, 604 can be circumferentially disposed around an inner shaft 1812 extending along the elongated axis 306. In aspects, the cylindrical base 304, 604 can be coupled to the inner shaft 1812 such that it can translate (e.g., proximally and / or distally along the elongated axis 306) and rotate (e.g., 360 degrees about the elongated axis 306) with the inner shaft 1812. In other examples, the cylindrical base 304, 604 can be coupled to the inner shaft 1812 and configured to translate (e.g., proximally and / or distally along the elongated axis 306) and rotate (e.g., 360 degrees about the elongated axis 306) relative to the inner shaft 1812. In yet another example, the cylindrical base 304, 604 can be coupled to the inner shaft 1812 and configured to translate (e.g., proximally and / or distally along the elongated axis 306) with the inner shaft 1812 but rotate relative to the shaft (e.g., 360 degrees about the elongated axis 306). The cylindrical base 304, 604 can be coupled to the inner shaft 1812 any suitable way, such as for example, by press fitting, mechanical coupling (e.g., screws, bolts, nuts, fasteners), soldering, plastic and / or polymer welding, and / or the like.

[0051] In some aspects, as illustrated, a spindle 400, 700, 1000, 1100, 1200, 1300 (described in greater detail hereinafter) can circumscribe an outer circumferential surface 312, 612 of the cylindrical base 304, 604. In some aspects, the spindle 400, 700, 1000, 1100, 1200, 1300 can be rotatably coupled to the cylindrical base 304, 604. For example, the spindle 400, 700, 1000, 1100, 1200, 1300 can be configured to rotate (e.g., 360 degrees) about the elongated axis 306 relative to the cylindrical base 304. Alternatively, in some aspects, which will be described in further detail hereinafter, the spindle 400, 700, 1000, 1100, 1200, 1300 can be fixed to the cylindrical base 304, 604 such that it does not rotate (see FIG. 14 description). In some aspects, such as shown, the cylindrical base 304,604 and the spindle 400, 700, 1000, 1100, 1200, 1300 can be disposed within the sheath 1804. In some such aspects, the sheath 1804 can be configured to translate relative to the spindle 400, 700, 1000, 1100, 1200, 1300 and the cylindrical base 304, 604.

[0052] In further aspects, a friction feature 314, 614 can be associated with the cylindrical base 304, 604 and / or the spindle 400, 700, 1000, 1100, 1200, 1300. The term “associated with” as utilized herein should be construed broadly with respect to the relationship between the friction feature 314, 614 and the cylindrical base 304, 604 and / or the spindle 400, 700, 1000, 1100, 1200, 1300. For example, in some aspects, the term “associated with” can mean that the friction feature 314, 614 can be an integral, unitary part formed as part of the spindle 400, 700, 1000, 1100, 1200, 1300 itself and / or can be coupled to the spindle 400, 700, 1000, 1100, 1200, 1300. Additionally and / or alternatively, “associated with” can mean that the friction feature 314, 614 can be an integral, unitary part formed as part of the cylindrical base 304, 604 itself and / or can be coupled to the cylindrical base 304, 604. Additionally and / or alternatively, “associated with” can mean that the friction feature 314, 614 can be an integral, unitary part formed as part of the cylindrical base 304, 604 and separately as part of the spindle 400, 700, 1000, 1100, 1200, 1300 and configured to interact with one another. Furthermore, the term “associated with” can mean that the friction feature 314, 614 can be a separate component distinct from both spindle 400, 700, 1000, 1100, 1200, 1300 and the cylindrical base 304, 604 that interacts with one or both of the spindle 400, 700, 1000, 1100, 1200, 1300 and / or the cylindrical base 304, 604. Therefore, the term “associated with” is meant to be an all-encompassing term that covers any functional relationship between the friction feature 314, 614 and at least one of or both of the spindle 400, 700, 1000, 1100, 1200, 1300 or the cylindrical base 304, 604, regardless of whether the friction feature 314, 614 is a unitary part of or is coupled to the spindle 400, 700, 1000, 1100, 1200, 1300, the cylindrical base 304, 604, and / or is a separate component.

[0053] In aspects, the friction feature 314, 614 can be configured to increase a rotational resistance between the spindle 400, 700, 1000, 1100, 1200, 1300 and the cylindrical base 304, 604. In some aspects, increasing the rotational resistance between the spindle 400, 700, 1000, 1100, 1200, 1300 and the cylindrical base 304, 604 can be beneficial for loading a prosthetic heart valve into the transcatheter device 302, 602, such as for example, when loading the prosthetic heart valve 200 into the transcatheter device 302,602. For example, typically a prosthetic heart valve is crimped around a valve holder, such as for example, where the valve holder comprises a spindle, a shaft, and / or a base member. If the valve holder, such as a spindle, were to freely rotate (e.g., with minimal resistance), it may be difficult for a clinician to load the prosthetic valve into the transcatheter device. However, by increasing the rotational resistance between the spindle 400, 700, 1000, 1100, 1200, 1300 and the cylindrical base 304, 604, in some aspects, the difficulty of loading the prosthetic heart valve into the transcatheter device 302, 602 can be reduced. In further aspects, increasing the rotational resistance between the spindle 400, 700, 1000, 1100, 1200, 1300 and the cylindrical base 304, 604 can help to minimize loading failure, such as for example, where the prosthetic heart valve is improperly positioned within the transcatheter device 302, 602, by allowing more precise positioning of the prosthetic heart valve in the transcatheter device 302, 602.

[0054] In aspects, as shown in FIGS. 3 and 6, a distal end portion 316, 616 of the cylindrical base 304, 604 can comprise a first coupling feature 318, 618. In aspects, the first coupling feature 318, 618 can comprise a first threaded portion (e.g., an exterior thread or an interior thread), as shown. For example, the outer circumferential surface 312, 612 of the cylindrical base 304, 604 can define the first threaded portion. In further aspects, the transcatheter device 302, 602 can further comprise a retaining member 320, 620 circumscribing the first coupling feature 318, 618 of the cylindrical base 304, 604. In aspects, the retaining member 320, 620 (e.g., a nut) can comprise a second threaded portion (e.g., an interior thread or an exterior thread), as shown. For example, an inner circumferential surface of the retaining member 320, 620 can define the second threaded portion. In aspects, the second threaded portion of the retaining member 320, 620 can correspond to the threads of the first threaded portion of the first coupling feature 318, 618. In this way, the retaining member 320, 620 and the first coupling feature 318, 618 of the cylindrical base 304, 604 can be threadably coupled together. In some alternative aspects (not shown), the first coupling feature 318, 618 can comprise an interior thread (e.g., as opposed to the illustrated exterior thread) while the retaining member 320, 620 can comprise an exterior thread (e.g., as opposed to the illustrated interior thread). Accordingly, the retaining member 320, 620 and the first coupling feature 318, 618 of the cylindrical base 304, 604 can be threadably coupled together similarly as described above.

[0055] In aspects, a proximal end portion 322, 622 of the cylindrical base 304, 604 can comprise a second coupling feature 324, 624. In some aspects, the second coupling feature 324, 624 can comprise a radially projecting protrusion circumscribing the elongated axis 306. For example, as illustrated, the radially projecting protrusion can be projecting radially outward relative to the outer circumferential surface 312, 612 of the cylindrical base 304, 604. In aspects, the spindle 400, 700, 1000, 1100, 1200, 1300 can be disposed between the retaining member 320, 620 and the second coupling feature 324, 624 of the cylindrical base 304, 604. For example, by disposing the spindle 400, 700, 1000, 1100, 1200, 1300 between the retaining member 320, 620 and the second coupling feature 324, 624 of the cylindrical base 304, 604 the spindle 400, 700, 1000, 1100, 1200, 1300 can rotate about the elongated axis 306 but be prevented from proximally and / or translating relative to the cylindrical base 304, 604.

[0056] Turning generally to FIGS. 4-5, 7-8, and 10-14 embodiments of the spindle 400, 700, 1000, 1100, 1200, 1300 are shown. FIG. 5 is a schematic cross-sectional view of FIG. 4 taken at line 5-5 of the spindle 400 shown in FIG. 4, while FIG. 8 is a schematic cross- sectional view of FIG. 7 taken at line 8-8 of the spindle 700 shown in FIG. 7. Additionally, FIG. 14 is a schematic cross-sectional view to represent similar features of the embodiments of the spindle 1000, 1100, 1200, 1300 of FIGS. 10-13. However, FIG. 14 is merely schematic and should not be construed as imparting limitation as to features of the discussed embodiments, unless specifically denoted. Thus, while in some aspects, the schematic cross-sectional view shown in FIG. 14 may show a general feature of the spindle 1000, 1100, 1200, 1300, this does not necessarily mean that the embodiments shown in FIGS. 10-13 are limited to the general feature shown in FIG. 14. Rather, the embodiments shown in FIGS. 10-13 may comprise shapes and / or features that are different than the cross-sectional view shown in FIG. 14, other than where specifically stated.

[0057] In aspects, the spindle 400, 700, 1000, 1100, 1200, 1300 can comprise a cylindrical body 402, 702, 1002, 1102, 1202, 1302. In aspects, the cylindrical body 402, 702, 1002, 1102, 1202, 1302 can extend in a distal direction 328 (see additionally FIGS. 3 and 6) of the elongated axis 306. In aspects, the cylindrical body 402, 702, 1002, 1102, 1202, 1302 can comprise an outer circumferential surface 404, 704, 1004, 1104, 1204, 1304 and an inner circumferential surface 502, 802, 1402 (see the cross-sectional view shown in FIGS.5, 8, and 14). In aspects, the inner circumferential surface 502, 802, 1402 can define a lumen 504, 804, 1404 (best shown in FIGS. 5, 8, and 14) of the spindle 400, 700, 1000, 1100, 1200, 1300 extending along the distal direction 328 of the elongated axis 306.

[0058] In aspects, the spindle 400, 700, 1000, 1100, 1200, 1300 can comprise at least one pocket 406, 706, 1006, 1106, 1206, 1306. In aspects, the at least one pocket 406, 706, 1006, 1106, 1206, 1306 can extend radially inward from the outer circumferential surface 404, 704, 1004, 1104, 1204, 1304 of the spindle 400, 700, 1000, 1100, 1200, 1300 towards the inner circumferential surface 502, 802, 1402 of the spindle 400, 700, 1000, 1100, 1200, 1300. In aspects, which will become more apparent hereinafter, the at least one pocket 406, 706, 1006, 1106, 1206, 1306 can be configured to received a portion of a prosthetic heart valve. For example, the at least one pocket can be configured to receive a proximal portion (outflow portion) of the prosthetic heart valve 200, such as for example, the at least one pocket 406, 706, 1006, 1106, 1206, 1306 can be configured to receive the paddle 238. In this way, the at least one pocket 406, 706, 1006, 1106, 1206, 1306 will prevent axial movement (e.g., movement in the direction of the elongated axis 306) of the prosthetic heart valve 200 (e.g., such as when the sheath 1804 is proximally and / or distally retracted) by inhibiting the paddle 238 from moving outside of the at least one pocket 406, 706, 1006, 1106, 1206, 1306 (e.g., the paddle 238 is trapped within the at least one pocket 406, 706, 1006, 1106, 1206, 1306) when the prosthetic heart valve 200 is compressed within the sheath 1804 .

[0059] In aspects, the at least one pocket 406, 706, 1006, 1106, 1206, 1306 can comprise an outwardly facing surface 408, 708, 1008, 1108, 1208, 1308 defined between a first pocket wall 410, 710, 1010, 1110, 1210, 1310 facing a second pocket wall 412, 712, 1012, 1112, 1212, 1312 opposite the first pocket wall 410, 710, 1010, 1110, 1210, 1310. In aspects, the at least one pocket 406, 706, 1006, 1106, 1206, 1306 can comprise a pocket end wall 414, 714, 1014, 1114, 1214, 1314 extending between and connecting proximal end portions 416, 716, 1016, 1116, 1216, 1316 of the first pocket wall 410, 710, 1010, 1110, 1210, 1310 and the second pocket wall 412, 712, 1012, 1112, 1212, 1312. In aspects, as shown, the pocket end wall 414, 714, 1014, 1114, 1214, 1314 can comprise an arcuate surface (e.g., having a continuous radius or several varying radii) extending between and connecting the proximal end portions 416, 716, 1016, 1116, 1216, 1316 of the first pocketwall 410, 710, 1010, 1110, 1210, 1310 and the second pocket wall 412, 712, 1012, 1112, 1212, 1312.

[0060] In further aspects, the at least one pocket 406, 706, 1006, 1106, 1206, 1306 can further comprise a first pocket channel 418, 718, 1018, 1118, 1218, 1318 extending into the outwardly facing surface 408, 708, 1008, 1108, 1208, 1308 and extending centrally between distal end portions 420, 720, 1020, 1120, 1220, 1320 of the first pocket wall 410, 710, 1010, 1110, 1210, 1310 and the second pocket wall 412, 712, 1012, 1112, 1212, 1312. With additional reference to FIG. 15, a schematic cross-sectional view is shown generally for embodiments of the spindle 400, 700, 1000, 1100, 1200, 1300. In some aspects, the first pocket channel 418, 718, 1018, 1118, 1218, 1318 and the outwardly facing surface 408, 708, 1008, 1108, 1208, 1308 can define a planar surface 422, 722, 1022, 1122, 1222, 1322. As best shown in FIG. 15, in aspects, the outwardly facing surface 408, 708, 1008, 1108, 1208, 1308 can comprise a pair of sloped surfaces 424, 724, 1024, 1124, 1224, 1324. In some aspects, a first sloped surface of the pair of sloped surfaces 424, 724, 1024, 1124, 1224, 1324 can slope downwardly from the planar surface 422, 722, 1022, 1122, 1222, 1322 towards one of the first pocket wall 410, 710, 1010, 1110, 1210, 1310 orthe second pocket wall 412, 712, 1012, 1112, 1212, 1312. In some such aspects, a second sloped surface of the pair of sloped surfaces 424, 724, 1024, 1124, 1224, 1324 can slope downwardly from the planar surface 422, 722, 1022, 1122, 1222, 1322 towards a different one of the first pocket wall 410, 710, 1010, 1110, 1210, 1310 or the second pocket wall 412, 712, 1012, 1112, 1212, 1312. In further aspects, each sloped surface of the pair of sloped surfaces 424, 724, 1024, 1124, 1224, 1324 can intersect the planar surface 422, 722, 1022, 1122, 1222, 1322 at an acute angle 1502. In aspects, the acute angle 1502 can face in a direction of one of the first pocket wall 410, 710, 1010, 1110, 1210, 1310 orthe second pocket wall 412, 712, 1012, 1112, 1212, 1312. For example, in some aspects, the acute angle 1502 of the first sloped surface of the pair of sloped surfaces 424, 724, 1024, 1124, 1224, 1324 can face one of the first pocket wall 410, 710, 1010, 1110, 1210, 1310 orthe second pocket wall 412, 712, 1012, 1112, 1212, 1312, while the acute angle 1502 of the second sloped surface of the pair of sloped surfaces 424, 724, 1024, 1124, 1224, 1324 can face the other one of the first pocket wall 410, 710, 1010, 1110, 1210, 1310 orthe second pocket wall 412, 712, 1012, 1112, 1212, 1312. In some aspects, the acute angle 1502 can comprise an angle from about 10 degrees to about 30degrees. For example, in some aspects, the acute angle 1502 can comprise an angle of about 10 degrees, or about 15 degrees, or about 20 degrees, or about 25 degrees, or about 30 degrees. In some aspects, the at least one pocket 406, 706, 1006, 1106, 1206, 1306, as shown in FIG. 15, can comprise a pair of pockets that are diametrically opposed to one another around the elongated axis 306. In aspects, both pockets of the pair of pockets can be the same as the at least one pocket 406, 706, 1006, 1106, 1206, 1306 described herein.

[0061] As generally shown in FIGS. 4, 7, and 10-13. In further aspects, the at least one pocket 406, 706, 1006, 1106, 1206, 1306 can be further defined by a first support structure 426, 726, 1026, 1126, 1226, 1326 and a second support structure 428, 728, 1028, 1128, 1228, 1328. In aspects, the first support structure 426, 726, 1026, 1126, 1226, 1326 and the second support structure 428, 728, 1028, 1128, 1228, 1328 can each comprise a columnar member extending radially outward from one of the pair of sloped surfaces 424, 724, 1024, 1124, 1224, 1324. In aspects, as shown, the first support structure 426, 726, 1026, 1126, 1226, 1326 can be identical to the second support structure 428, 728, 1028, 1128, 1228, 1328 although different structural configurations may be provided in further examples. The first support structure 426, 726, 1026, 1126, 1226, 1326 and the second support structure 428, 728, 1028, 1128, 1228, 1328 can comprise any suitable cross- sectional shape, such as for example, a circular cross section, a rectangular cross-section, a square cross-section, an octagonal cross-section, an irregularly (e.g., not have a particular shape) shaped cross-section, and / or the like. For example, as shown, the first support structure 426, 726, 1026, 1126, 1226, 1326 and the second support structure 428, 728, 1028, 1128, 1228, 1328 can comprise rectangular shaped support structures comprising one or more rounded comers, for example, to eliminate sharp edges and / or comers.

[0062] In aspects, as shown, the first pocket channel 418, 718, 1018, 1118, 1218, 1318 can extend centrally between the first support structure 426, 726, 1026, 1126, 1226, 1326 and the second support structure 428, 728, 1028, 1128, 1228, 1328. In aspects, a width W of the first pocket channel 418, 718, 1018, 1118, 1218, 1318 can be defined by a distance between the first support structure 426, 726, 1026, 1126, 1226, 1326 and the second support structure 428, 728, 1028, 1128, 1228, 1328. In some examples, the width W can be large enough to receive the stem portion 240 (see FIG. 2) of the paddle 238, such that the stem portion 240 can fit between the first support structure 426, 726, 1026, 1126, 1226, 1326 and the second support structure 428, 728, 1028, 1128, 1228, 1328.

[0063] With reference now to FIG. 3, particular embodiments of the transcatheter device 302 will be discussed. In aspects, the friction feature 314 can comprise a friction ring 326 circumferentially disposed between the cylindrical base 304 and the spindle 400, 1000, 1100, 1200, 1300. In aspects, the friction ring 326 can comprise a continuous ring circumscribing the elongated axis 306. In this way, the friction ring 326 can provide additional friction between the spindle 400, 1000, 1100, 1200, 1300 and the cylindrical base 304 to prevent the spindle 400, 1000, 1100, 1200, 1300 from freely rotating about elongated axis 306 relative to the cylindrical base 304, such as for example, to provide the benefits mentioned previously (e.g., to aide a clinician in loading a prosthetic heart valve in the transcatheter device 302). For example, in some aspects, as shown in FIG. 5, the inner circumferential surface 502 of the spindle 400 can comprise a relatively smooth inner circumferential surface to allow for rotation between the cylindrical base 304; however, the friction ring 326 can then provide an increased frictional resistance, as described, between the cylindrical base 304 and the spindle 400, 1000, 1100, 1200, 1300 to prevent free rotation of the spindle 400, 1000, 1100, 1200, 1300 relative to the cylindrical base 304. In some aspects, the friction ring 326 can comprise a polymer. In some non-limiting examples, the polymer can comprise Polyurethane (PU), Ethylene Propylene Diene Monomer (EPDM), Nitrile Butadiene Rubber (NBR), Hydrogenated Nitrile Butadiene Rubber (HNBR), silicone rubber, Neoprene, and / or the like. Any other suitable material can be utilized for the friction ring 326. In aspects, the friction ring 326 can comprise any suitable cross-sectional shape, such as for example, a circular cross- sectional shape, a rectangular cross-sectional shape, a square cross-sectional shape, and / or the like. In some aspects (not shown) the friction ring 326 can be a continuous or discontinuous ring formed integrally as part of either one of the spindle 400, 1000, 1100, 1200, 1300 and / or the cylindrical base 304, and can function similarly as described above.

[0064] With additional reference to FIGS. 4-5, the spindle 400 is shown. In some aspects, the spindle 400 can comprise a circumferential groove 506 (see FIG. 5) configured to receive a portion of the friction ring 326. For example, a width A of the circumferential groove can be slightly larger than, less than, or about equal to a width of the friction ring 326 such that a portion of the friction ring 326 can be disposed within the circumferential groove 506. In aspects, a depth B of the groove can be defined by a distance extending into the inner circumferential surface 502 of the spindle 400. In some aspects where thefriction ring comprises a circular cross-sectional shape, an inner circumferential surface of the circumferential groove 506 can match an outer convex surface of the friction ring 326 although the inner surface of the circumferential groove 506 can comprise other shapes in further embodiments. In further aspects where the friction ring comprises a circular cross- sectional shape, a diameter of the friction ring can be greater than the depth B of the groove 506 such that a portion of the friction ring 326 protrudes outside of the groove 506 when the friction ring is seated within the groove 506. While the circumferential groove 506 has been described specifically with reference to the spindle 400 illustrated in FIGS. 4-5, the circumferential groove can be utilized in addition to and / or interchangeably with any of the features described hereinafter with reference to the spindle 1000, 1100, 1200, 1300. For example, while the schematic cross-sectional view in FIG. 14 of the spindle 1000, 1100, 1200, 1300 does not show a circumferential groove in order to demonstrate various other features of the spindle 1000, 1100, 1200, 1300, the circumferential groove 506 can be incorporated into any of the embodiments of the spindle 1000, 1100, 1200, 1300, similarly as described with reference to the spindle 400.

[0065] In some embodiments, the friction feature 614 can comprise a plurality of protrusions extending radially from one of the cylindrical base and the inner circumferential surface of the spindle and a plurality of surface discontinuities extending into the other of the cylindrical base and the inner circumferential surface of the spindle. For example, as shown in FIG. 6, the friction feature 614 can comprise a plurality of protrusions 626 extending radially from the cylindrical base 604 and the plurality of surface discontinuities 902 (see FIG. 9) can extend into the the inner circumferential surface 802 of the spindle 700, 1000, 1100, 1200, 1300. In addition or alternatively, although not shown, some or all of the plurality of protrusions 626 can extend from the spindle 700, 1000, 1100, 1200, 1300, while some or all of the plurality of surface discontinuities 902 can extend into the cylindrical base 604. In one non-limiting example, in some aspects, as shown in FIG. 6, the plurality of protrusions 626 can comprise bumps, extrusions, projections, raised bosses, studs, pillars, knobs, protruding nodules, domeshaped protuberances and / or the like. In some aspects, the plurality of surface discontinuities 902 can comprise openings, apertures, orifices, voids, indentions, cavities, recesses, depressions, dimples, pickets, and / or the like.

[0066] As utilized herein, the term “surface discontinuities” should be construed to mean an increase in the areal average surface roughness (Sa) after forming the plurality of surface discontinuities 902. The areal average surface roughness value should be calculated on the raw material used to manufacture the inner circumferential surface 802 or the cylindrical base 604 (e.g., whichever will include the surface discontinuities 902) at the location of the raw material in which the plurality of surface discontinuities 902 will extend into. The calculated areal average surface roughness value of the raw material should be should then be compared to another areal average surface roughness value taken on the inner circumferential surface 802 or the cylindrical base 604 (e.g., along a length in the direction of the elongated axis 306 of the inner circumferential surface 802 or the cylindrical base 604; whichever will include the surface discontinuities 902) at a location where the plurality of surface discontinuities 902 are located. The surface area utilized to calculate the areal average surface roughness for the raw material and the inner circumferential surface 802 or the cylindrical base 604 should be substantially equal to one another. The areal average surface roughness value of the raw material should be less than the areal average surface roughness value of the inner circumferential surface 802 or the cylindrical base 604 where the plurality of surface discontinuities 902 are located. It can be appreciated that the areal average surface roughness can be determined utilizing know techniques for determining areal average surface roughness; however, the same technique and process should be utilized for both the raw material and the inner circumferential surface 802 or the cylindrical base 604.

[0067] With additional reference to FIG. 9, which illustrates a cross-section along line 9-9 of the spindle 700, one non-limiting example of the plurality of surface discontinuities 902 are shown. As depicted, in some aspects, each surface discontinuity of the plurality of surface discontinuities 902 can comprise an aperture 904 extending from the inner circumferential surface 802 of the spindle 700 to the outer circumferential surface 704 of the spindle 700. Each aperture 904 can comprise any suitable shaped apertures, such as for example, a circular apertures (as shown), oval apertures, square apertures, rectangular apertures, and / or the like. Each surface discontinuity of the plurality of surface discontinuities 902 can comprise any of the other aforementioned discontinuities, such as an indentation (e.g., does not extend all the way through the spindle 700). Accordingly, each of these other surface discontinuities of the plurality of surface discontinuities 902can comprise any suitable shape, such as for example but not limited to, circular discontinuities, square discontinuities, rectangular discontinuities, oval discontinuities, and / or the like.

[0068] In aspects, the plurality of surface discontinuities 902 can comprise any number of surface discontinuities, such as for example but not limited to, four surface discontinuities, five surface discontinuities, six surface discontinuities, seven surface discontinuities, eight surface discontinuities, nine surface discontinuities, etc. In further aspects, the plurality of protrusions 626 can comprise any number of protrusions, such as for example but not limited to, four protrusions, five protrusions, six protrusions, seven protrusions, etc. It can be appreciated that in some aspects, more or less of the plurality of surface discontinuities 902 and / or the plurality of protrusions 626 can be provided in order to modify the degree of rotational resistance or freedom experienced by the spindle 700.

[0069] While apertures are shown in the spindle 700 in FIG. 9, in other embodiments, the same or similar apertures (e.g., or the other described surface discontinuities, such as indentations) could be alternatively formed within the cylindrical base 604 (e.g., while the plurality of protrusions 626 are then formed within the spindle 700), similarly as described with reference to FIG. 9. It is emphasized herein that while the plurality of surface discontinuities 902 (e.g., apertures) and the plurality of protrusions 626 have been described specifically with reference to the spindle 700 illustrated in FIGS. 7-9, the plurality of surface discontinuities 902 and the plurality of protrusions 626 can be utilized in addition to and / or interchangeably with any of the features described hereinafter with reference to the spindle 1000, 1100, 1200, 1300. For example, while the schematic cross- sectional view in FIG. 14 of the spindle 1000, 1100, 1200, 1300 does not show the plurality of surface discontinuities 902 or the plurality of protrusions 626 in order to demonstrate various other features of the spindle 1000, 1100, 1200, 1300, the plurality of surface discontinuities 902 or the plurality of protrusions 626 can be incorporated into any of the embodiments of the spindle 1000, 1100, 1200, 1300, similarly as described with reference to the spindle 700.

[0070] Turning back to FIG. 6, as shown, the plurality of protrusions 626 can be configured to rotatably engage the plurality of surface discontinuities 902 to increase the rotational resistance between the spindle 700, 1000, 1100, 1200, 1300 and the cylindrical base 604. For example, as illustrated, the plurality of surface discontinuities 902 and theplurality of protrusions 626 can together form a clocking system. In some such examples, when the plurality of protrusions 626 are rotated to a specific rotational orientation relative to the plurality of surface discontinuities 902, the plurality of protrusions 626 can engage the plurality of surface discontinuities 902 and create an interference to prevent free rotation of the spindle 700, 1000, 1100, 1200, 1300. In aspects, by creating a rounded (e.g., sloped) transition on each protrusion of the plurality of protrusions 626 and / or on an opening of the plurality of surface discontinuities 902 on the inner circumferential surface 802, 1402 of the spindle 700, 1000, 1100, 1200, 1300, the rotational resistance can be increased to prevent unobstructed rotation, but the spindle 700, 1000, 1100, 1200, 1300 will still be able to rotate (e.g., 360 degrees) when an increased rotational force is applied to the spindle 700, 1000, 1100, 1200, 1300 that overcomes the added rotational resistance of the plurality of surface discontinuities 902. For example, when the plurality of protrusions 626 are rotationally aligned with the plurality of surface discontinuities 902 and a great enough rotational force is applied to the spindle 700, 1000, 1100, 1200, 1300, the plurality of protrusions 626 can rotate out of the plurality of surface discontinuities 902 (e.g., slide up the sloped transition) in order to rotate (e.g., 360 degrees) again. Thus, the spindle 700, 1000, 1100, 1200, 1300 will still be able still rotate but will require a greater rotational force in order to rotate when the plurality of protrusions 626 are engaged with the plurality of surface discontinuities 902.

[0071] As utilized herein, the term “engage” can mean that the plurality of protrusions 626 are mated, interfaced, interlocked, intermeshed, contacted, and / or the like with the plurality of surface discontinuities 902. In some aspects (not shown), in order to maintain some increased rotational resistance (e.g., to prevent free rotation) but reduce the amount of rotational force required to rotate the spindle 700, 1000, 1100, 1200, 1300, each protrusion of the plurality of protrusions 626 can comprise a retractable protrusion. In some examples, the retractable protrusion can comprise a spring-loaded protrusion where the spring can increase a height of the protrusions when engaged with the plurality of surface discontinuities 902 and decrease a height of each protrusion of the plurality of protrusions (e.g., when rotational force is applied) when not engaged with the plurality of surface discontinuities 902. For example, each protrusion of the plurality of protrusions 626 can comprise a helical compression spring or a coil spring that can compress whenrotating the spindle 700, 1000, 1100, 1200, 1300 and uncompress when engaged with the plurality of surface discontinuities 902.

[0072] It can be appreciated in some aspects that by providing the spindle 400, 700, 1000, 1100, 1200, 1300 with the ability to rotate as described above, a prosthetic heart valve can more easily be deployed from a transcatheter device. For example, in some procedures such as when replacing a native heart valve, a transcatheter device including a prosthetic heart valve held in a compressed arrangement within a sheath and a spindle, will be navigated within the tortuous vasculature of a patient and then subsequently guided into the native heart valve. The transcatheter device may then need to be further manipulated (e.g., rotated and translated) within the native heart valve in order to properly align the prosthetic heart valve within the native heart valve. However, due to this manipulation along with manipulation of the sheath when deploying the prosthetic heart valve, a proximal portion and a distal portion of the prosthetic heart valve may become twisted due to a torque differential between the proximal and distal ends of the prosthetic heart valve. Accordingly, this torque differential may lead to a failure of the prosthetic heart valve to be released from the spindle, such as for example, when the heart valve (e.g., a paddle of the heart valve) gets stuck on a ridge within a pocket of the spindle (e.g., the paddle is rotated 90 degrees relative to the pocket of the spindle). It can thus be appreciated that in some aspects, providing the spindle 400, 700, 1100, 1200, 1300 with the ability to rotate relative to the cylindrical base 304, 607 can minimize the differential torque by equalizing a torque between the proximal portion of the prosthetic heart valve and the distal portion of the prosthetic heart valve. For example, with refence to the prosthetic heart valve 200, when the paddle 238 is positioned within the at least one pocket 1106, 1206, 1306, and the transcatheter device 302, 602 is maneuvered through a patient and the sheath 1804 is retracted, the spindle 400, 700, 1100, 1200, 1300 will be able to rotate about the elongated axis 306 to sustainably balance (e.g., equate) the torque between the proximal portion 206 and the distal portion 208 of the prosthetic heart valve 200 to prevent the paddle from rotating (e.g., and getting stuck) relative to the at least one pocket 406, 706, 1006, 1106, 1206, 1306. The paddle 238 will have the differential toque reduced and thus the paddle can then be released properly from the spindle 400, 700, 1000, 1100, 1200, 1300.

[0073] The term “free rotation” as utilized herein should be construed to mean rotation without obstructions. Thus, the term “free rotation” as applied to the spindle 400, 700,1000, 1100, 1200, 1300 should be construed as if the spindle 400, 700, 1000, 1100, 1200, 1300 were rotating around the cylindrical base 304, 604 unobstructed by any physical intervening components.

[0074] Hereinafter, various additional features of the spindle 400, 700, 1000, 1100, 1200, 1300 will now be discussed. With reference to FIGS. 4, 7, 11-14, and 16-17, in some aspects, the spindle 400, 700, 1100, 1200, 1300 can comprise at least one support bridge 430, 730, 1130, 1230, 1330 connecting the distal end portion 420, 720, 1120, 1220, 1320 of the first pocket wall 410, 710, 1110, 1210, 1310 to the first support structure 426, 726, 1126, 1226, 1326 and / or the distal end portion 420, 720, 1120, 1220, 1320 of the second pocket wall 412, 712, 1112, 1212, 1312 to the second support structure 428, 728, 1128, 1228, 1328. In some examples, the at least one support bridge 430, 730, 1130, 1230, 1330 can comprise a first support bridge connecting the distal end portion 420, 720, 1120, 1220, 1320 of the first pocket wall 410, 710, 1110, 1210, 1310 to the first support structure 426, 726, 1126, 1226, 1326, and a second support bridge (e.g., the same or similar as the first support bridge) connecting the distal end portion 420, 720, 1120, 1220, 1320 of the second pocket wall 412, 712, 1112, 1212, 1312 to the second support structure 428, 728, 1128, 1228, 1328. In other aspects, only one support bridge can connect the distal end portion 420, 720, 1120, 1220, 1320 of the first pocket wall 410, 710, 1110, 1210, 1310 to the first support structure 426, 726, 1126, 1226, 1326 or the distal end portion 420, 720, 1120, 1220, 1320 of the second pocket wall 412, 712, 1112, 1212, 1312 to the second support structure 428, 728, 1128, 1228, 1328. In some such aspects, the other of the first support structure 426, 726, 1126, 1226, 1326 or the second support structure 428, 728, 1128, 1228, 1328 that does not include the support bridge can comprise a channel similar to that described hereinafter with reference to FIG. 10.

[0075] Turning specifically to the at least one support bridge 430, 730 of the spindle 400, 700, shown in FIGS. 4 and 7, in aspects, the at least one support bridge 430, 730 can comprise a vertical surface connecting the distal end portion 420, 720 of the first pocket wall 410, 710 to the first support structure 426, 726 and / or the distal end portion 420, 720 of the second pocket wall 412, 712 to the second support structure 428, 728. In aspects, the vertical surface can be defined by a plane that extends in a direction substantially orthogonal (e.g., 90 degrees) to the elongated axis 306. For example, as shown in the orientation in FIGS. 4 and 7 the plane can extend indefinitely into the page, while theelongated axis 306 extends parallel with the page, and thus the vertical surface can extend along the orthogonal plane. In further aspects, the vertical surface can comprise a continuous radius that connects the distal end portion 420, 720 of the first pocket wall 410, 710 to the first support structure 426, 726 and / or the distal end portion 420, 720 of the second pocket wall 412, 712 to the second support structure 428, 728. In some aspects, the vertical surface can comprise multiple radii that connect the distal end portion 420, 720 of the first pocket wall 410, 710 to the first support structure 426, 726 and / or the distal end portion 420, 720 of the second pocket wall 412, 712 to the second support structure 428, 728.

[0076] Now viewing the spindle 1100, 1200, 1300 in FIGS. 11-13 and 16-17, in aspects, the at least one support bridge 1130, 1230, 1330 can comprise a sloped surface 1132, 1232, 1332 extending outwardly from the outwardly facing surface 1108, 1208, 1308 and in the distal direction 328 of the elongated axis 306. More particularly, with reference to FIG. 17, a schematic cross-section taken at line 17-17 of FIGS. 11-13 is shown. FIG. 17 is merely schematic to represent similar features of the embodiments of the spindle 1100, 1200, 1300 of FIGS. 11-13. However, FIG. 17 is merely schematic and should not be construed as imparting limitation as to features of the discussed embodiments, unless specifically denoted. Thus, while in some aspects, the schematic cross-sectional view shown in FIG. 17 may show a general feature of the spindle 1100, 1200, 1300, this does not necessarily mean that the embodiments shown in FIGS. 11-13 are limited to the general feature shown in FIG. 17. Rather, the embodiments shown in FIGS. 11-13 may comprise shapes and / or features that are different than the cross-sectional view shown in FIG. 17, other than where specifically stated. As shown, the sloped surface 1132, 1232, 1332 can extend in the distal direction 328 of the elongated axis 306 from at least one of the pair of sloped surfaces 1124, 1224, 1324 of the outwardly facing surface 1108, 1208, 1308. In aspects, the sloped surface 1132, 1232, 1332 can be defined as a resultant vector 1702 (indicated by an arrow) of a first slope vector 1704 (indicated by an arrow) and a second slope vector 1706 (indicated by an arrow), where the second slope vector 1706 is orthogonal to the first slope vector 1704.

[0077] FIG. 16 illustrates an enlarged view taken at view 16 of FIG. 14. As shown, the slope vectors (e.g., the resultant vector 1702, the first slope vector 1704, and the second slope vector 1706) illustrated (and described above) in FIG. 17 have been projected ontothe planar surface 1122, 1222, 1322 of the outwardly facing surface 1108, 1208, 1308 of the spindle 1100, 1200, 1300 in order to show features of the spindle 1100, 1200, 1300. In further aspects, the sloped surface 1132, 1232, 1332 can form an acute angle 1602 extending in a direction (e.g., indicated generally by the resultant vector 1702) with respect to the planar surface 1122, 1222, 1322 defined by the first pocket channel 1118, 1218, 1318 and the outwardly facing surface 1108, 1208, 1308. In aspects, the acute angle 1602 can be from about 10 degrees to about 70 degrees. For example, in aspects, the acute angle 1602 can comprise an acute angle of about 10 degrees, or about 15 degrees, or about 20 degrees, or about 25 degrees, or about 30 degrees, or about 35 degrees, or about 40 degrees, or about 45 degrees, or about 50 degrees, or about 55 degrees, or about 60 degrees, or about 65 degrees, or about 70 degrees. In other examples, however, the planar surface 1122, 1222, 1322 can be less than 10 degrees or greater than 70 degrees (e.g., but less than 90 degrees).

[0078] It can be appreciated that in some aspects, providing the spindle 1100, 1200, 1300 with the sloped surface 1132, 1232, 1332 can be beneficial in releasing a prosthetic heart valve from the spindle 1100, 1200, 1300. For example, similar to the problem discussed above about differential torque in a prosthetic heart valve and with refence to the prosthetic heart valve 200, when the paddle 238 is positioned within the at least one pocket 1106, 1206, 1306, the paddle 238 will be able to ramp over the sloped surface 1132, 1232, 1332 to prevent the paddle 238 from getting caught and / or stuck within the at least one pocket 1106, 1206, 1306.

[0079] Now, turning to the spindle 1000 shown in FIG. 10, is some aspects, as illustrated, the spindle 1000 can comprise at least one second pocket channel 1030 positioned between the distal end portion 1020 of the first pocket wall 1010 and the first support structure 1026 and / or positioned between the distal end portion 1020 of the second pocket wall 1012 and the second support structure 1028. For example, in some aspects, the at least one second pocket channel 1030 can comprise a second pocket channel positioned between the distal end portion 1020 of the first pocket wall 1010 and the first support structure 1026, and another second pocket channel positioned between the distal end portion 1020 of the second pocket wall 1012 and the second support structure 1028. In some examples, similar to that described above for the sloped surface 1132, 1232, 1332, the at least one second pocket channel 1030 can help to prevent the above-describedproblem of a paddle getting stuck within a transcatheter device. Similarly, as described above, providing the additional channel(s) (e.g., the at least one second pocket channel 1030) can allow a paddle (e.g., such as the paddle 238) to slide between the additional channels, such as when a paddle has rotated relative to the at least one pocket 1006 of the spindle 1000, in order to release the paddle from the spindle 1000.

[0080] Now returning to the spindle 1000, 1100, 1200, 1300 shown in FIGS. 10-13 more generally, in aspects, as shown in FIG. 14, the inner circumferential surface 1402 of the spindle 1000, 1100, 1200, 1300 can comprise an optional interior thread 1406 configured to be received on the cylindrical base 304, 604. For example, while not specifically illustrated, the interior thread 1406 can be configured to be threaded onto an external thread of the cylindrical base 304, 604. In this way, as generally mentioned above, the spindle 1000, 1100, 1200, 1300 and the cylindrical base 304, 604 can rotate integrally as a unit. For instance, in some examples, where it is desired to prevent the spindle 1000, 1100, 1200, 1300 from rotating relative to the cylindrical base 304, 604, such as for example, where precise prosthetic heart valve alignment is required, the spindle 1000, 1100, 1200, 1300 can be threaded to the cylindrical base 304, 604 to prevent such rotation. While FIG. 14 illustrates the interior thread 1406, in some examples, the interior thread 1406 can be omitted and the spindle 1000, 1100, 1200, 1300 cross-section can look similar to the cross section of the spindle 400, 700 (see FIGS. 4 and 7) where the spindle 1000, 1100, 1200, 1300 can then be configured to rotate as described with reference to the spindle 400, 700.

[0081] It can be appreciated that the features described herein with reference to the spindle 400, 700 can be utilized in addition to or interchangeably with anyone of the features of the spindle 1000, 1100, 1200, 1300. More particularly, for example, any one or more of the features described with reference to the at least one pocket 1006, 1106, 1206, 1306 of the spindle 1000, 1100, 1200, 1300 can be utilized interchangeably with or in addition to the at least one pocket 406, 706 of the spindle 400, 700.

[0082] In some aspects, it can be appreciated that by including features of the spindle 1000, 1100, 1200, 1300 in combination with either one of the spindle 400, 700, the transcatheter device 302, 602 can further prevent a prosthetic heart valve from becoming stuck within the spindle 400, 700, 1000, 1100, 1200, 1300. For example, by including one of the sloped surface 1132, 1232, 1332 or the at least one second pocket channel 1030 in combination with the friction ring 326, the plurality of protrusions 626, or the plurality ofsurface discontinuities 902, a prosthetic heart valve becoming stuck within the transcatheter device 302, 602 can further be prevented or minimized.

[0083] FIG. 18 illustrates an exploded view of an embodiment of the transcatheter device 302, 602 illustrating the handle device 1802 comprising one or more actuators 1808. In aspects, the one or more actuators 1808 can be configured to actuate the sheath 1804 (e.g., by a sliding movement of the actuator). For example, the one or more actuators 1808 can proximally advance and / or distally retract the sheath 1804. In some aspects, the one or more actuators 1808 can be configured to rotate (e.g., 360 degree) an outer shaft 1810, the inner shaft 1812, the sheath 1804, the cylindrical base 304, 604 (see FIGS. 3 and 6), and / or the spindle 400, 700, 1000, 1100, 1200, 1300. In some examples, the one or more actuators 1808 can proximally retract and / or distally advance the sheath 1804 by way of the outer shaft 1810 coupled to the sheath 1804. In some aspects, as shown, the one or more actuators 1808 can be configured to actuate the inner shaft 1812. For example, the one or more actuators 1808 can distally advance and / or proximally retract the inner shaft 1812. In some aspects, proximally retracting and / or distally advancing the inner shaft 1812 can proximally retract and / or distally advance the cylindrical base 304, 604 and / or the spindle 400, 700, 1000, 1100, 1200, 1300. In some aspects, the one or more actuators 1808 can be configured to rotate (e.g., 360 degree) the inner shaft 1812. In some aspects, rotating the inner shaft 1812 can rotate the cylindrical base 304, 604 and / or the spindle 400, 700, 1000, 1100, 1200, 1300 relative to one another. In some embodiments the inner shaft 1812 can comprise a shaft assembly. For example, one or more shafts can be coupled together to define the inner shaft 1812.

[0084] In some aspects, the handle device 1802 can be configured to actuate components of the transcatheter device 302, 602 by any suitable actuating means. For example, the handle device 1802 can actuate components of the transcatheter device 302, 602 by sliding movements (e.g., proximally and / or distally sliding the actuator in a proximal or distal direction), rotational movements (e.g., clockwise and / or counter clockwise rotation), and / or pressure actuated movements (e.g., button presses). In some aspects, the handle device 1802 can be configured to be mechanically actuated, electrically actuated, electromechanically actuated, and / or any other suitable actuating means. The above examples are not meant to be limiting, and any other suitable handle devices may be utilized with the transcatheter device 302, 602 described herein.

[0085] The above-described configurations of the handle device 1802 are merely exemplary, and thus any other suitable configurations for actuating the transcatheter device 302, 602 can be utilized. Furthermore, the handle device 1802 should not be construed as being configured to only actuate the above-mentioned components. Rather, the handle device 1802 can actuate any other suitable components of the transcatheter device 302, 602. Furthermore, because the handle device 1802 is merely exemplary, any other suitable handle device may be utilized in actuating the transcatheter device 302, 602.

[0086] In accordance with the disclosure, non-limiting aspects of the disclosure will now be described. Various combinations of the aspects can be provided in accordance with the disclosure.

[0087] Aspect 1. A transcatheter device comprising a cylindrical base extending along an elongated axis. The transcatheter device comprises a spindle circumscribing an outer circumferential surface of the cylindrical base and rotatably coupled to the cylindrical base. The spindle is configured to rotate about the elongated axis relative to the cylindrical base. The transcatheter device further comprises a friction feature associated with the cylindrical base and the spindle. The friction feature is configured to increase a rotational resistance between the spindle and the cylindrical base.

[0088] Aspect 2. The transcatheter device of Aspect 1, wherein a distal end portion of the cylindrical base comprises a first coupling feature.

[0089] Aspect 3. The transcatheter device of Aspect 2, wherein the first coupling feature comprises a first threaded portion.

[0090] Aspect 4. The transcatheter device of any one of Aspects 2 - 3, further comprising a retaining member circumscribing the first coupling feature of the cylindrical base.

[0091] Aspect 5. The transcatheter device of Aspect 4, wherein the retaining member comprises a second threaded portion.

[0092] Aspect 6. The transcatheter device of any one of Aspects 4 - 5, wherein the retaining member and the first coupling feature of the cylindrical base are threadably coupled together.

[0093] Aspect 7. The transcatheter device of any one of Aspects 4 - 6, wherein a proximal end portion of the cylindrical base comprises a second coupling feature.

[0094] Aspect 8. The transcatheter device of Aspect 7, wherein the second coupling feature comprises a radially projecting protrusion circumscribing the elongated axis.

[0095] Aspect 9. The transcatheter device of any one of Aspects 7 - 8, wherein the spindle is disposed between the retaining member and the second coupling feature of the cylindrical base.

[0096] Aspect 10. The transcatheter device of any one of Aspects 1 - 9, wherein the friction feature comprises a plurality of protrusions extending radially from one of the cylindrical base and an inner circumferential surface of the spindle, and a plurality of surface discontinuities extending into the other of the cylindrical base and the inner circumferential surface of the spindle.

[0097] Aspect 11. The transcatheter device of Aspect 10, wherein the plurality of protrusions are configured to rotatably engage the plurality of surface discontinuities to increase the rotational resistance between the spindle and the cylindrical base.

[0098] Aspect 12. The transcatheter device of any one of Aspects 1 - 9, wherein the friction feature comprises a friction ring circumferentially disposed between the cylindrical base and the spindle.

[0099] Aspect 13. The transcatheter device of Aspect 12, wherein the friction ring comprises a continuous ring circumscribing the elongated axis.

[0100] Aspect 14. The transcatheter device of any one of Aspects 12 - 13, wherein the friction ring comprises a polymer.

[0101] Aspect 15. The transcatheter device of any one of Aspects 1 - 14, wherein the spindle further comprises a cylindrical body extending in a distal direction of the elongated axis. The cylindrical body comprises an outer circumferential surface and an inner circumferential surface. The inner circumferential surface defines a lumen of the spindle extending along the distal direction of the elongated axis. The spindle further comprises at least one pocket extending radially inward from the outer circumferential surface of the spindle towards the inner circumferential surface of the spindle. The at least one pocket comprising an outwardly facing surface defined between a first pocket wall facing a second pocket wall opposite the first pocket wall. The at least one pocket further comprises a first pocket channel extending into the outwardly facing surface and extending centrally between distal end portions of the first pocket wall and the second pocket wall.

[0102] Aspect 16. The transcatheter device of Aspect 15, wherein the at least one pocket is further defined by a first support structure and a second support structure, wherein the first pocket channel extends centrally between the first support structure and the second support structure, and a width of the first pocket channel is defined by a distance between the first support structure and the second support structure.

[0103] Aspect 17. The transcatheter device of Aspect 16, further comprising at least one support bridge connecting the distal end portion of the first pocket wall to the first support structure and / or the distal end portion of the second pocket wall to the second support structure, wherein the at least one support bridge comprises a sloped surface extending outwardly from the outwardly facing surface and in the distal direction of the elongated axis.

[0104] Aspect 18. The transcatheter device of Aspect 17, wherein the sloped surface forms an acute angle extending in a direction with respect to a planar surface defined by the first pocket channel and the outwardly facing surface.

[0105] Aspect 19. The transcatheter device of Aspect 18, wherein the acute angle is from about 10 degrees to about 70 degrees.

[0106] Aspect 20. The transcatheter device of any one of Aspects 17-19, wherein the at least one support bridge comprises a first support bridge connecting the distal end portion of the first pocket wall to the first support structure, and a second support bridge connecting the distal end portion of the second pocket wall to the second support structure.

[0107] Aspect 21. The transcatheter device of Aspect 16, further comprising at least one second pocket channel positioned between the distal end portion of the first pocket wall and the first support structure and / or positioned between the distal end portion of the second pocket wall and the second support structure.

[0108] Aspect 22. The transcatheter device of Aspect 21 , wherein the at least one second pocket channel comprises a second pocket channel positioned between the distal end portion of the first pocket wall and the first support structure, and another second pocket channel positioned between the distal end portion of the second pocket wall and the second support structure.

[0109] It should be understood that while various aspects have been described in detail relative to certain illustrative and specific examples thereof, the present disclosure should not be considered limited to such, as numerous modifications and combinations of the disclosed features are possible without departing from the scope of the following claims.

Claims

What is claimed is:

1. A transcatheter device (302, 602) comprising: a cylindrical base (304, 604) extending along an elongated axis (306); a spindle (400, 700, 1000, 1100, 1200, 1300) circumscribing an outer circumferential surface (312, 612) of the cylindrical base (304, 604) and rotatably coupled to the cylindrical base (304, 604), wherein the spindle (400, 700, 1000, 1100, 1200, 1300) is configured to rotate about the elongated axis (306) relative to the cylindrical base (304, 604); and a friction feature (314, 614) associated with the cylindrical base (304, 604) and the spindle (400, 700, 1000, 1100, 1200, 1300), wherein the friction feature (314, 614) is configured to increase a rotational resistance between the spindle (400, 700, 1000, 1100, 1200, 1300) and the cylindrical base (304, 604).

2. The transcatheter device (302, 602) of claim 1, wherein a distal end portion (316, 616) of the cylindrical base (304, 604) comprises a first coupling feature (318, 618).

3. The transcatheter device (302, 602) of any one of claims 1-2, further comprising a retaining member (320, 620) circumscribing the first coupling feature (318, 618) of the cylindrical base (304, 604).

4. The transcatheter device (302, 602) of any one of claims 2-3, wherein the retaining member (320, 620) and the first coupling feature (318, 618) of the cylindrical base (304, 604) are threadably coupled together.

5. The transcatheter device (302, 602) of any one of claims 3-4, wherein a proximal end portion (322, 622) of the cylindrical base (304, 604) comprises a second coupling feature (324, 624).

6. The transcatheter device (302, 602) of claim 5, wherein the second coupling feature (324, 624) comprises a radially projecting protrusion circumscribing the elongated axis (306).

7. The transcatheter device (302, 602) of any one of claims 5-6, wherein the spindle (400, 700, 1000, 1100, 1200, 1300) is disposed between the retaining member (320, 620) and the second coupling feature (324, 624) of the cylindrical base (304, 604).

8. The transcatheter device (602) of any one of claims 1-7, wherein the friction feature (614) comprises a plurality of protrusions (626) extending radially from one of the cylindrical base (604) and an inner circumferential surface (802) of the spindle (700, 1000, 1100, 1200, 1300), and a plurality of surface discontinuities (902) extending into the other of the cylindrical base (604) and the inner circumferential surface (802) of the spindle (700, 1000, 1100, 1200, 1300).

9. The transcatheter device (302) of any one of claims 1-8, wherein the friction feature (314) comprises a friction ring (326) circumferentially disposed between the cylindrical base (304) and the spindle (400, 1000, 1100, 1200, 1300).

10. The transcatheter device (302, 602) of any one of claims 1-9, wherein the spindle (400, 700, 1000, 1100, 1200, 1300) further comprises: a cylindrical body (402, 702, 1002, 1102, 1202, 1302) extending in a distal direction (328) of the elongated axis (306), the cylindrical body (402, 702, 1002, 1102, 1202, 1302) comprising an outer circumferential surface (404, 704, 1004, 1104, 1204, 1304) and an inner circumferential surface (502, 802), wherein the inner circumferential surface (502, 802) defines a lumen (504, 804) of the spindle (400, 700, 1000, 1100, 1200, 1300) extending along the distal direction (328) of the elongated axis (306); and at least one pocket (406, 706, 1006, 1106, 1206, 1306) extending radially inward from the outer circumferential surface (404, 704, 1004, 1104, 1204, 1304) of the spindle (400, 700, 1000, 1100, 1200, 1300) towards the inner circumferentialsurface (502, 802) of the spindle (400, 700, 1000, 1100, 1200, 1300), the at least one pocket (406, 706, 1006, 1106, 1206, 1306) comprising: an outwardly facing surface (408, 708, 1008, 1108, 1208, 1308) defined between a first pocket wall (410, 710, 1010, 1110, 1210, 1310) facing a second pocket wall (412, 712, 1012, 1112, 1212, 1312) opposite the first pocket wall (410, 710, 1010, 1110, 1210, 1310); and a first pocket channel (1018) extending into the outwardly facing surface (408, 708, 1008, 1108, 1208, 1308) and extending centrally between distal end portions (420, 720, 1020, 1120, 1220, 1320) of the first pocket wall (410, 710, 1010, 1110, 1210, 1310) and the second pocket wall (412, 712, 1012, 1112, 1212, 1312).

11. The transcatheter device (302, 602) of claim 10, wherein the at least one pocket (406, 706, 1006, 1106, 1206, 1306) is further defined by a first support structure (426, 726, 1026, 1126, 1226, 1326) and a second support structure (428, 728, 1028, 1128, 1228, 1328), wherein the first pocket channel (418, 718, 1018, 1118, 1218, 1318) extends centrally between the first support structure (426, 726, 1026, 1126, 1226, 1326) and the second support structure (428, 728, 1028, 1128, 1228, 1328), and a width of the first pocket channel (418, 718, 1018, 1118, 1218, 1318) is defined by a distance between the first support structure (426, 726, 1026, 1126, 1226, 1326) and the second support structure (428, 728, 1028, 1128, 1228, 1328).

12. The transcatheter device (302, 602) of claim 11, further comprising at least one support bridge (1130, 1230, 1330) connecting the distal end portion (1120, 1220, 1320) of the first pocket wall (1120, 1220, 1320) to the first support structure (1126, 1226, 1326) and / or the distal end portion (1120, 1220, 1320) of the second pocket wall (1112, 1212,1312) to the second support structure (1128, 1228, 1328), wherein the at least one support bridge (1130, 1230, 1330) comprises a sloped surface (1132, 1232, 1332) extending outwardly from the outwardly facing surface (1108, 1208, 1308) and in the distal direction13. The transcatheter device (302, 602) of claim 12, wherein the sloped surface (1108, 1208, 1308) forms an acute angle (1704) extending in a direction with respect to a planar surface (1122, 1222, 1322) defined by the first pocket channel (1118, 1218, 1318) and the outwardly facing surface (1108, 1208, 1308).

14. The transcatheter device (302, 602) of any one of claims 12-13, wherein the at least one support bridge comprises a first support bridge (1130, 1230, 1330) connecting the distal end portion (1120, 1220, 1320) of the first pocket wall (1110, 1210, 1310) to the first support structure (1126, 1226, 1326), and a second support bridge (1130, 1230, 1330) connecting the distal end portion (1120, 1220, 1320) of the second pocket wall (1112, 1212, 1312) to the second support structure (1128, 1228, 1328).

15. The transcatheter device (302, 602) of claim 11, further comprising at least one second pocket channel (1030) positioned between the distal end portion (1020) of the first pocket wall (1010) and the first support structure (1026) and / or positioned between the distal end portion (1020) of the second pocket wall (1012) and the second support structure (1028).

Images