WO2024158613A1

WO2024158613A1 - Prosthetic heart valve

Info

Publication number: WO2024158613A1
Application number: PCT/US2024/011970
Authority: WO
Inventors: Niall F. Duffy
Original assignee: Medtronic, Inc.
Priority date: 2023-01-25
Filing date: 2024-01-18
Publication date: 2024-08-02

Abstract

A heart valve prosthesis includes an annular frame extending along a valve axis between a first valve end of the heart valve prosthesis and a second valve end of the heart valve prosthesis. The annular frame includes a plurality of frame members and is adjustable between a radially-collapsed position and a radially-expanded position. The heart valve prosthesis includes a support arm extending between a first end and a second end along an arm axis that is substantially parallel to the valve axis. The first end includes an attachment member including a wall surrounding a recess. A frame member of the plurality of frame members is received within the recess to attach the support arm to an outer radial side of the annular frame. The second end extends adjacent to and detached from the outer radial side. Methods of implanting a heart valve prosthesis are provided.

Description

PROSTHETIC HEART VALVE

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] The application claims the benefit of U.S. Provisional Application No. 63/441,062, filed January 25, 2023, the entire contents of which are incorporated herein by reference.

FIELD

[0002] The present disclosure relates generally to a prosthetic heart valve and, more particularly, to a prosthetic heart valve comprising a support arm that assists in positioning the heart valve prosthesis at a treatment location.

BACKGROUND

[0003] It is known to provide a prosthetic heart valve for implantation within a target site of the vasculature of a patient. The heart valve prosthesis can be moved from a radially-collapsed position to a radially-expanded position. The heart valve prosthesis can comprise a frame and a valve sub-assembly, such as, for example, a skirt and a plurality of leaflets. Positioning of the heart valve prosthesis at a treatment location can be difficult and time-consuming.

SUMMARY

[0004] The following presents a simplified summary of the disclosure to provide a basic understanding of some aspects described in the detailed description.

[0005] In aspects, a heart valve prosthesis comprises an annular frame extending along a valve axis between a first valve end of the heart valve prosthesis and a second valve end of the heart valve prosthesis. The annular frame comprises a plurality of frame members and is configured to be adjustable between a radially-collapsed position and a radially-expanded position. The heart valve prosthesis comprises a support arm extending between a first end and a second end along an arm axis that is substantially parallel to the valve axis. The first end comprises an attachment member comprising a wall surrounding a recess. A frame member of the plurality of frame members is configured to be received within the recess to attach the support arm to an outer radial side of the annular frame. The second end extends adjacent to and detached from the outer radial side.

[0006] In aspects, the attachment member comprises a first segment and a second segment. The first segment is spaced apart from the second segment and defines the recess between the first segment and the second segment.

[0007] In aspects, the first segment comprises a first wall and a second wall. The first wall defines a first angle relative to the second wall that is within a range from about 70 degrees to about 110 degrees. The first wall extends along a first plane and the second wall extends along a second plane.

[0008] In aspects, the second segment comprises a third wall and a fourth wall. The third wall defines a second angle relative to the fourth wall that is within a range from about 70 degrees to about 110 degrees. The third wall extends along a third plane that is substantially parallel to the first plane, and the fourth wall extends along the second plane.

[0009] In aspects, the second wall extends between a first end, which is attached to the first wall, and a second end. The fourth wall extends between a third end, which is attached to the third wall, and a fourth end. The second end and the fourth end are spaced a distance apart and define a gap between the second wall and the fourth wall.

[0010] In aspects, the distance is less than a width of the frame member received within the recess. The width is measured along a width axis that is parallel to the second plane and intersects the first wall and the third wall.

[0011] In aspects, the support arm comprises a nitinol material.

[0012] In aspects, a native leaflet is positioned between the second end and the outer radial side of the frame.

[0013] In aspects, the support arm is spaced a separating distance apart from the outer radial side that is less than about 3 millimeters.

[0014] In aspects, a heart valve prosthesis comprises an annular frame extending along a valve axis between a first valve end of the heart valve prosthesis and a second valve end of the heart valve prosthesis. The annular frame comprises a plurality of frame members and is configured to be adjustable between a radially-collapsed position and a radially-expanded position. The heart valve prosthesis comprises a support arm extending between a first end and a second end along an arm axis that is substantially parallel to the valve axis. The first end comprises a first attachment member comprising a first wall surrounding a first recess. A first frame member of the plurality of frame members is configured to be received within the first recess. The first end comprises a second attachment member comprising a second wall surrounding a second recess. A second frame member of the plurality of frame members is configured to be received within the second recess. The first attachment member is spaced circumferentially apart from the second attachment member around the annular valve such that the first attachment member and the second attachment member are configured to attach the support arm to an outer radial side of the annular frame. The support arm comprises an elongated body member extending non-linearly between the first attachment member and the second attachment member. The body member comprises a rounded shape at the second end that is adjacent to and detached from the outer radial side of the annular frame. A separating distance separating the outer radial side from the support arm is non-constant between the first end and the second end.

[0015] In aspects, an attachment plane that is perpendicular to the valve axis intersects the first attachment member and the second attachment member.

[0016] In aspects, the support arm comprises a shape that substantially matches a shape of the outer radial side of the annular frame.

[0017] In aspects, the support arm comprises a nitinol material.

[0018] In aspects, a native leaflet is positioned between the second end and the outer radial side of the frame.

[0019] In aspects, methods of implanting a heart valve prosthesis can comprise positioning a heart valve prosthesis at a treatment location. The heart valve prosthesis comprises a frame and a support arm attached to an outer radial side of the frame. Methods comprise removing a first portion of the heart valve prosthesis from a first sheath. The first portion of the heart valve prosthesis comprises the support arm such that the support arm moves radially outwardly from a radially-collapsed position while in the first sheath to a radially-expanded position outside of the first sheath. Methods comprise moving the heart valve prosthesis such that the support arm is located radially outwardly from a native leaflet at the treatment location. Methods comprise removing a second portion of the heart valve prosthesis from a second sheath such that the frame moves from the radially-collapsed position to the radially-expanded position and the native leaflet is positioned radially between, and in contact with, the frame and the support arm.

[0020] In aspects, the first portion of the heart valve prosthesis comprises a central region spaced a first distance from the first valve end and a second distance from the second valve end such that upon removing the first portion, the first valve end is positioned within the first sheath and the second valve end is positioned within the second sheath.

[0021] In aspects, the second portion of the heart valve prosthesis comprises a second end region extending from the second valve end to the first portion such that removing the second portion comprises removing the second valve end from the second sheath.

[0022] In aspects, after removing the second portion, methods comprise removing a third portion of the heart valve prosthesis from the first sheath. The third portion comprises a first end region extending from the first valve end to the first portion.

[0023] In aspects, the support arm applies a force to the native leaflet to bias the native leaflet toward the frame and secure the frame relative to the native leaflet.

[0024] In aspects, removing the first portion of the heart valve prosthesis from the first sheath comprises moving the first sheath in a first movement direction, and removing the second portion of the heart valve prosthesis from the second sheath comprises moving the second sheath in a second movement direction opposite the first movement direction.

[0025] 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 and constitute 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

[0026] 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:

[0027] FIG. 1 schematically illustrates example aspects of a heart valve prosthesis in a radially-expanded position in accordance with aspects of the disclosure;

[0028] FIG. 2 illustrates a perspective view of a support arm attached to a frame of the heart valve prosthesis of FIG. 1 in accordance with aspects of the disclosure;

[0029] FIG. 3 illustrates a side view of an attachment member of the support arm being attached to a frame member of the frame in accordance with aspects of the disclosure;

[0030] FIG. 4 illustrates a side view of an attachment member of the support arm being attached to a frame member of the frame in accordance with aspects of the disclosure;

[0031] FIG. 5 illustrates a side view of an attachment member of the support arm being attached to a frame member of the frame in accordance with aspects of the disclosure;

[0032] FIG. 6 illustrates a side view of the support arm attached to the frame in accordance with aspects of the disclosure;

[0033] FIG. 7 illustrates a side view of the support arm engaging a native leaflet to position the heart valve prosthesis at a treatment location in accordance with aspects of the disclosure;

[0034] FIG. 8 illustrates a side view of a delivery apparatus for delivering the heart valve prosthesis to a treatment location in accordance with aspects of the disclosure;

[0035] FIG. 9 illustrates a side view of a delivery apparatus for delivering the heart valve prosthesis to a treatment location with a first sheath moving in a movement direction in accordance with aspects of the disclosure;

[0036] FIG. 10 illustrates a side view of a delivery apparatus for delivering the heart valve prosthesis to a treatment location in accordance with aspects of the disclosure;

[0037] FIG. 11 illustrates a side view of a delivery apparatus for delivering the heart valve prosthesis to a treatment location with a second sheath moving in a movement direction in accordance with aspects of the disclosure; and [0038] FIG. 12 illustrates a side view of a delivery apparatus for delivering the heart valve prosthesis to a treatment location in accordance with aspects of the disclosure.

DETAILED DESCRIPTION

[0039] 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.

[0040] 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.

[0041] 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 be further understood that the endpoints of each of the ranges are significant both in relation to the other endpoint, and independently of the other endpoint.

[0042] Directional terms as used herein - for example up, down, right, left, front, back, top, bottom, upper, lower, first, second, etc. - are made only with reference to the figures as drawn and are not intended to imply absolute orientation.

[0043] 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.

[0044] 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.

[0045] 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.

[0046] As used herein, the terms “comprising,” and “including,” and variations thereof, shall be construed as synonymous and open-ended, unless otherwise indicated. A list of elements following the transitional phrases comprising or including is a nonexclusive list, such that elements in addition to those specifically recited in the list may also be present.

[0047] 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. For example, a “substantially planar” surface is intended to denote a surface that is planar or approximately planar. 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.

[0048] 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.

[0049] 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 (e.g., super-elastic 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 L-D lactic copolymer, oligo caprylactone copolymer and poly cyclo-octine can be used separately or in conjunction with other shape memory polymers.

[0050] 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.

[0051] 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.

[0052] FIG. 1 illustrates a prosthetic annular heart valve prosthesis 101 (hereinafter “heart valve prosthesis” or “valve prosthesis” or “valve”) that can be delivered to a desired location within a body of a patient, for example, a patient’s heart. The valve prosthesis 101 can be moved between a radially-collapsed position and a radially-expanded position, with the valve prosthesis 101 illustrated in the radially-expanded position in FIG. 1. The valve prosthesis 101 can move through a vasculature of the patient while in the radially-collapsed position, and, upon reaching the desired location, can move to the radially-expanded position.

[0053] The valve prosthesis 101 can comprise an expandable stent or frame 103 that supports a valve sub-assembly within the interior of the frame 103. In aspects, the frame 103 can be self-expanding to return to a radially-expanded deployed state from a radially-compressed or constricted delivery state and may be made from stainless steel, a pseudo-elastic metal such as a nickel titanium alloy or Nitinol, 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 the wire or tubular structure that forms the frame 103 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, or a polymer, such as any of the polymers disclosed in U.S. Pat. Appl. Pub. No. 2004/0111111 to Lin, which is incorporated by reference herein in its entirety. Alternatively, the valve prosthesis 101 may be balloonexpandable or mechanically-expandable (e.g., via an actuator mechanism) as would be understood by one of ordinary skill in the art.

[0054] The valve prosthesis 101 can comprise the valve sub-assembly 104 positioned within the interior of the frame 103. The valve sub-assembly 104 is capable of blocking flow in one direction to regulate flow through the valve prosthesis 101 via valve leaflets 106 that may form a bicuspid or tricuspid replacement valve. FIG. 1 illustrates an exemplary tricuspid valve comprising three leaflets 106, although a bicuspid leaflet configuration is also envisioned. If the valve prosthesis 101 is configured for placement within a native valve comprising three leaflets such as the aortic, tricuspid, or pulmonary valves, the valve prosthesis 101 may comprise three valve leaflets 106. If the valve prosthesis 101 is configured for placement within a native valve comprising two leaflets such as the mitral valve, the valve prosthesis 101 may comprise two valve leaflets 106. The valve leaflets 106 may be sutured or otherwise securely and sealingly attached to the interior surface of the frame 103 and/or a graft material or skirt 108 which encloses or lines the frame 103. The leaflets 106 may be attached along their bases at a margin of attachment (MOA) 110 to the skirt 108, for example, using sutures or a suitable biocompatible adhesive. Adjoining pairs of leaflets may be attached to one another at their lateral ends to form commissures, with free edges of the leaflets forming coaptation edges that meet in an area of coaptation.

[0055] In aspects, the valve prosthesis 101 can extend along a valve axis 105 between a first valve end 107 (e.g., outflow end) of the valve prosthesis 101 and a second valve end 109 (e.g., inflow end) of the valve prosthesis 101. The valve prosthesis 101 can comprise an inner passage 111 extending along the valve axis 105 between the first valve end 107 and the second valve end 109. The inner passage 111 may be circumferentially bounded by the frame 103. The frame 103 can expand from a radially-collapsed position (e g., illustrated in FIGS. 8-10) to a radially-expanded position (e.g., illustrated in FIG. 1). In aspects, in the radially-expanded position, the frame 103 can comprise a first diameter 115, and in the radially-collapsed position, the frame 103 can comprise a second diameter that is less than the first diameter 115. [0056] The frame 103 of the transcatheter heart valve prosthesis 101 further includes a plurality of struts 117 that are arranged to form a plurality of openings or cells 119 arranged circumferentially around the longitudinal valve axis 105 of the transcatheter heart valve prosthesis 101 and longitudinally to form a tubular structure defining the inner passage 111 of the transcatheter heart valve prosthesis 101. The frame 103 is configured to secure the valve sub-assembly 104 within the inner passage 111 of the frame 103 and to secure the transcatheter heart valve prosthesis 101 in place in the vasculature of the patient. The struts 117 are defined herein as the elongated wire segments of the frame 103. Struts 117 come together to form crowns 116 or nodes 118, as can be seen in FIG. 1. The frame 103 can comprise a plurality of frame members, wherein the frame members comprise one or more of the struts 117, the crowns 116, and/or the nodes 118. The frame 103 of the heart valve prosthesis 101 includes a plurality of cells 119 defined as the spaces between the plurality of crowns 116, the plurality of nodes 118, and the plurality of struts 117.

[0057] In the example embodiment shown in FIG. 1, the plurality of cells 119 may be diamond-shaped, although other shaped cells and/or one or more cells having different sizes (e g., a relatively larger cell for coronary access) may be provided without departing from the scope of the disclosure. Although not shown, in some embodiments the transcatheter heart valve prosthesis 101 may include an outer skirt extending circumferentially around an outer circumference of the frame 103 at or near the inflow end (e g., second valve end 109) to prevent paravalvular leakage of blood around the outside of the transcatheter heart valve prosthesis 101 once implanted in the patient.

[0058] Although disclosed herein as a self-expanding frame 103 formed of a shapememory material, in other aspects, the frame 103 can comprise one or more frame members that may be attached and interconnected. For example, the frame 103 can comprise frame members that may be pivotably attached such that the frame members can pivot between the radially-collapsed position and the radially-expanded position when acted on by a mechanical force or a mechanical device. The frame members can be pivotably attached in several ways, for example, by mechanical fasteners (e.g., rivets, screws, bolts), by snapfitting without fasteners, etc. and/or may comprise the shape-memory material that can move to a predetermined shape. In aspects, the frame 103 may also be expanded from the collapsed position to the expanded position using a balloon or other inflation device to plastically deform the material from which the frame 103 is manufactured. .

[0059] In aspects, the frame 103 can comprise an asymmetric hourglass shape comprising an enlarged first section 124, a constricted or waist region 125, and a second section 126. In aspects, the enlarged first section 124 can comprise a nominal deployed diameter 115, the second section 126 can comprise a nominal deployed diameter D2, and the waist region 125 can comprise a deployed substantially fixed diameter D3. In aspects, the valve prosthesis 101 can comprise a number of different configurations and sizes to meet different requirements of the location in which the valve prosthesis 101 may be implanted. When configured as a replacement for an aortic valve, the second section 126 can function as an inflow end of valve prosthesis 101 and extends into and anchors within the aortic annulus of a patient's left ventricle, while the first section 124 can function as an outflow end of the valve prosthesis 101 and may be positioned in the patient's ascending aorta. When configured as a replacement for a mitral valve, the enlarged first section 124 can function as an inflow end of valve prosthesis 101 and may be positioned in the patient's left atrium, while the second section 126 can function as an outflow end of the valve prosthesis 101 and can extend into and anchor within the mitral annulus of a patient's left ventricle. For example, U.S. Patent Application Publication Nos. 2012/0101572 to Kovalsky et al. and 2012/0035722 to Tuval, each of which are herein incorporated by reference in their entirety, illustrate heart valve prostheses configured for placement in a mitral valve. Each section of the frame 103 may comprise the same or different crosssection which may be for example circular, ellipsoidal, rectangular, hexagonal, rectangular, square, or other polygonal shape. As alternatives to the deployed asymmetric hourglass configuration of FIG. 1, the frame 103 may comprise a symmetric hourglass configuration, a generally tubular configuration, or other stent configuration or shape known in the art for valve replacement. The frame 103 also may comprise eyelets for use in loading the valve prosthesis 101 into a delivery catheter.

[0060] The valve prosthesis 101 can comprise a support arm 131 that can be attached to an outer radial surface of the frame 103. FIG. 1 illustrates the support arm 131 detached and spaced apart from the frame 103 for purposes of illustration. However, in operation, the support arm 131 can be attached to and in contact with the frame 103. The support arm 131 can extend between a first end 133 and a second end 135 along an arm axis 137 that may be substantially parallel to the valve axis 105. The support arm 131 can comprise a first attachment member 141 and a second attachment member 143 positioned at the first end 133. In aspects, the support arm 131 can comprise an elongated body member 145 extending non-linearly between the first attachment member 141 and the second attachment member 143. By extending non-linearly, in aspects, the body member 145 can comprise a rounded shape at the second end 135, and a shape that substantially matches a shape of the frame 103, for example, the first section 124, the waist region 125, and/or the second section 126. Initially, for example, prior to insertion of the valve prosthesis 101 into the patient’s vasculature, the support arm 131 may be detached and separated from the frame 103. To attach the support arm 131 to the outer radial surface of the frame 103, and as illustrated in FIG. 1, the support arm 131 can be moved in a movement direction toward the frame 103.

[0061] In aspects, a physician or other medical personnel may selectively add or remove the support arm 131 from the frame 103 prior to implantation, depending on whether a support arm 131 is desired for the medical procedure. For example, in some aspects, the physician may determine that one or more non-exclusive factors warrant the addition of one or more support arms 131, such as the patient’s anatomy, the level of calcification of the native valve leaflets, the age or other health characteristics of the patient, or whether the prosthetic heart valve prosthesis 101 is be employed to replace the function of a native heart valve or is being employed to replace the function of a previously implanted prosthetic heat valve (e.g., TAV-in-TAV procedure). Thus, by providing a support arm 131 that is selectively attachable and/or detachable from the frame 103, the physician is afforded the choice of more options and alternative configurations for the prosthetic heart valve prosthesis 101. Moreover, the physician may be able to employ an existing transcatheter heart valve prosthesis and selectively add the support arm 131 to the existing prosthesis without modifying the existing prosthesis.

[0062] It is envisioned that the support arm 131 could be provided alone to be employed with a separate prosthesis or could be provided together with the prosthesis. For example, in aspects, a medical device in accordance with aspects of the disclosure can include the support arm 131 provided separately, the support arm 131 provided together with but not attached to a prosthetic valve (e.g., provided in the same or corresponding packaging), or the support arm 131 provided together with and attached to a prosthetic valve. In the first example, the physician may employ the support arm 131 by selectively attaching the support arm 131 to an existing prosthesis (e.g., a prosthesis shipped, sold, or otherwise available independently from the support arm 131. In the second example, the physician may employ the support arm 131 by selectively attaching the support arm 131 to the prosthesis with which the support arm 131 was provided prior to implantation within a patient. In the third example, the physician may employ the support arm 131 by implanting the prosthesis and the support arm 131 attached thereto as provided. Optionally, in the third example, the physician may have at his or her disposal the prosthesis with the support arm 131 attached, and then prior to implantation, may decide to selectively remove one or more support arms from the prosthesis to which the support arm 131 was previously attached. Thus, the selectively removable and selectively attachable support arms 131 of the disclosure provide various options and alternative configurations using the same components.

[0063] FIG. 2 illustrates the support arm 131 in attachment with the outer radial surface of the frame 103. In aspects, the first attachment member 141 and the second attachment member 143 may be attached to the frame 103, for example, by being attached to one or more struts 117 of the frame 103. In this way, the support arm 131 may be fixed relative to the frame 103 such that the support arm 131 is limited from inadvertently detaching from the frame 103. The second end 135 may be adjacent to and detached from the outer radial side of the frame 103. Accordingly, the support arm 131 may be attached to the frame 103 at one end (e.g., the first end 133) and not attached to the frame 103 at an opposing end (e.g., the second end 135). In aspects, an attachment plane 201 that is perpendicular to the valve axis 105 can intersect the first attachment member 141 and the second attachment member 143, such that the first attachment member 141 and the second attachment member 143 may be located the same distance from the first valve end 107. The first attachment member 141 may be spaced circumferentially apart from the second attachment member 143 around the valve prosthesis 101 such that the first attachment member 141 and the second attachment member 143 can attach the support arm 131 to the outer radial side of the frame 103. In other aspects, one or both of the first attachment member 141 and the second attachment member 143 may be attached to the frame at any combination of a strut 117, a crown 116, and a node 118.

[0064] FIG. 3 illustrates an enlarged view of the first attachment member 141, wherein the first attachment member 141 may be substantially identical to the second attachment member 143. The first attachment member 141 can comprise a first segment 301 and a second segment 303. The first segment 301 can be spaced apart from the second segment 303 to define a recess 305 between the first segment 301 and the second segment 303. The first segment 301 can comprise a first wall 311 and a second wall 313, with the first wall 311 extending along a first plane 315 and the second wall 313 extending along a second plane 317. In aspects, the first plane 315 may be angled and non-planar with the second plane 317. For example, the first wall 311 can define a first angle 321 relative to the second wall 313 that may be within a range from about 70 degrees to about 110 degrees, or about 90 degrees. In this way, the second wall 313 can project from the first wall 311 toward the second segment 303. The second wall 313 can extend between a first end 325, which is attached to the first wall 311, and a second end 327. The recess 305 can be at least partially bounded on one side by the first wall 311 and on another side by the second wall 313.

[0065] The second segment 303 can be substantially identical to the first segment 301, with the second segment 303 spaced apart from, and arranged as a mirror image as, the first segment 301. For example, the second segment 303 can comprise a third wall 331 and a fourth wall 333, with the third wall 331 extending along a third plane 335 and the fourth wall 333 extending along the second plane 317. In aspects, the third plane 335 may be angled and non-planar with the second plane 317. For example, the third wall 331 can define a second angle 341 relative to the fourth wall 333 that may be within a range from about 70 degrees to about 110 degrees, or about 90 degrees. In this way, the fourth wall 333 can project from the third wall 331 toward the first segment 301. The fourth wall 333 can extend between a third end 345, which is attached to the third wall 331, and a fourth end 347. The recess 305 can be at least partially bounded on one side by the third wall 331 and on another side by the fourth wall 333. In aspects, the first wall 311 and the third wall 331 may be substantially parallel and spaced apart, with the recess 305 positioned therebetween. The second wall 313 and the fourth wall 333 may be co-planar along the second plane 317. In aspects, the second end 327 and the fourth end 347 can be spaced a distance 351 apart to define a gap 353 between the second wall 313 and the fourth wall 333. By providing the gap 353, a frame member 357 (e.g., any one or more of a strut 117, crown 116, or node 118) of the frame 103, with the frame member 357 being substantially identical to the frame members 116, 117, 118, can be inserted into the recess 305 through the gap 353. In aspects, the distance 351 may be less than a width 359 of the frame member 357 that can be received within the recess 305. The width 359 can be measured along a width axis 361 that is parallel to the second plane 317. The width axis 361 can intersect the first wall 311 and the third wall 331 when the frame member 357 is received within the recess 305 (e.g., illustrated in FIG. 5). The recess 305 may be bounded on substantially all sides but for the gap 353.

[0066] FIG. 3 illustrates the attachment member 141 prior to the frame member 357 being received within the recess 305 (e.g., similar to the detached position of the support arm 131 relative to the valve prosthesis 101 of FIG. 1). FIG. 4 illustrates the frame member 357 being inserted into the recess 305. For example, the attachment member 141 can comprise a nitinol material that, when cooled, can flex and move. In aspects, the attachment member 141 can be cooled by being immersed in a liquid, for example, water (e.g., ice water), a cooled saline solution, etc. Upon being cooled, the first segment 301 and the second segment 303 can be flexed away from one another. For example, the first segment 301 can be flexed in a first flexing direction 401 that is away from the second segment 303. In addition, the second segment 303 can be flexed in a second flexing direction 403, opposite the first flexing direction 401, that is away from the first segment 301. For example, without intending to be bound by theory, it is believed that by cooling a shape-memory material, the shape-memory characteristics may become temporarily delayed such that the attachment member 141 can temporarily deform to maintain the open configuration shown in FIG. 4 long enough to connect the attachment member 141 to the frame member 357. As the temperature of the shape-memory material increases, the shapememory characteristics are restored and the attachment member 141 returns to the original, predetermined shape set at the time of manufacture (see e.g., the configuration in FIG. 3). In this way, when flexed open, the first plane 315 of the first wall 311 may no longer be parallel with the third plane 335 of the third wall 331. By moving in the flexing directions 401, 403, the gap 353 can be increased in size, from the distance 351 to a second distance 405. In aspects, the second distance 405 can be larger than the width 359 of the frame member 357. As such, the frame member 357 can be moved in a movement direction 407 toward the attachment member 141, through the gap 353, and into the recess 305. In addition or alternatively, the attachment member 141 can be connected to the frame member 357 by moving the attachment member 141 in a direction opposite the movement direction 407 toward the frame member 357.

[0067] If employed with a step of cooling the attachment member 141, as the temperature of the shape-memory material increases, the shape-memory characteristics are restored and the attachment member 141 returns to the original, predetermined shape set at the time of manufacture, thereby at least partially enclosing and connecting to the frame member 357 as shown in FIG. 5. Although disclosed as including a step of cooling the attachment member 141 prior to or during connection with the frame member 357, such a step is optional. In some aspects, the attachment member 141 can be attached to the frame member 357 at room temperature or at any other temperature above or below room temperature. The attachment member 141 can also be attached to the frame member 357 in a gas (e.g., air) or liquid (e.g., saline water solution) environment. In some aspects, a mechanical device (e.g., pliers, tweezers, or other type of mechanical spreader or tool (not shown)) may be employed to flex one or both of the first segment 301 and the second segment 303 to open the attachment member 141 for connecting with the frame member 357. In addition or alternatively, the attachment member 141 can be connected to the frame member 357 by applying a force from the frame member 357 to the attachment member 141 to flex one or both of the first segment 301 and the second segment 303. For example, in aspects, the first segment 301 and/or the second segment 303 can be flexed with a mechanical tool and/or by pressing or pushing the attachment member 141 against the frame member 357 such that the first segment 301 and/or the second segment 303 elastically deform from the applied force and then return to the original shape (e.g., once connected to the frame member 357) when the applied force is decreased or removed. Similarly, in aspects, the attachment member 141 can be removed or disconnected from engagement with the frame member 357 by employing one or more techniques disclosed alone or in combination for engaging the attachment member 141 and the frame member 357 in a reverse manner such that the first segment 301 and the second segment 303 flex open and the attachment member 141 can be removed or disconnected from the frame member 357.

[0068] FIG. 5 illustrates the frame member 357 after being inserted into the recess 305 and after the first segment 301 and the second segment 303 have returned to their original positions. For example, with the frame member 357 positioned within the recess, the gap 353 can comprise the distance 351 (e.g., between the second wall 313 and the fourth wall 333) that is less than the width 359 of the frame member 357. In this way, the frame member 357 can be retained within the recess 305 by the second wall 313 and the fourth wall 333. The second attachment member 143, which may be substantially identical to the attachment member 141, can receive a frame member (e.g., which may be substantially identical to the frame member 357) in substantially the same manner as the frame member 357 is received by the attachment member 141. In this way, the second attachment member 143 can likewise be attached to a frame member of the frame 103. The support arm 131 is not limited to comprising two attachment members (e.g., 141, 143) at the first end 133. Rather, in aspects, the support arm 131 can comprise fewer or additional attachment members (e.g., one or more), with each attachment member configured to receive a frame member.

[0069] FIG. 6 illustrates an enlarged side view of the support arm 131 in relation to the outer radial side of the frame 103 with the support arm 131 attached to the frame 103. The support arm 131 can be spaced a separating distance 601 apart from the outer radial side of the frame 103. In aspects, the separating distance 601 may be less than about 3 millimeters. The separating distance 601 may be non-constant between the first end 133 and the second end 135. For example, the separating distance 601 may be less than about 3 millimeters at the first end 133, and, in aspects, less than about 1 millimeter or zero at the second end 135. In aspects, the second end 135 may be in contact with the outer radial side of the frame 103. As such, the separating distance 601 may decrease from the first end 133 toward the second end 135. In aspects, the support arm 131 can comprise a shape that substantially matches a shape of the outer radial side of the frame 103. For example, with the frame 103 comprising the hourglass shape illustrated in FIG. 1, the support arm 131 can comprise an undulating, hourglass shape between the first end 133 and the second end 135 substantially matching the shape of the frame 103.

[0070] FIG. 7 illustrates the support arm 131 attached to the frame 103 as the valve prosthesis 101 is positioned at a treatment location 701 within the vasculature of a patient. The treatment location 701 can comprise a native leaflet 703 that can be positioned between the second end 135 of the support arm 131 and the outer radial side of the frame 103. By being positioned radially between the second end 135 of the support arm 131 and the outer radial side of the frame 103, the native leaflet 703 can be located such that the frame 103 is positioned on an inner radial side of the native leaflet 703 and the support arm 131 is positioned on an outer radial side of the native leaflet 703. In aspects, the support arm 131 can apply a force, for example, a compressive force, to the native leaflet 703 to bias the native leaflet 703 toward the frame 103. In this way, the native leaflet 703 can be held by the support arm 131 such that the engagement between the support arm 131, the native leaflet 703, and the frame 103 can secure the valve prosthesis 101 at the treatment location 701 and limit the valve prosthesis 101 from moving relative to the native leaflet 703. Although disclosed as engaging a native leaflet 703, it is to be understood that one or more features of the disclosure may be employed alone or in combination to provide a support arm 131 and a frame 103 between which a non-native leaflet (e.g., a leaflet of a previously implanted transcatheter prosthetic valve) can be held, thereby facilitating a TAV-in-TAV procedure.

[0071] In aspects, the valve prosthesis 101 is not limited to comprising the one support arm (e.g., the support arm 131) illustrated herein. Rather, the valve prosthesis 101 can comprise a second support arm 707 that may be substantially identical in structure, function, and material to the support arm 131. The second support arm 707 can differ from the support arm 131 in that the second support arm 707 can be circumferentially offset from the support arm 131, for example, by about 180 degrees about the valve axis 105. In this way, the support arm 131 and the second support arm 707 can be attached to opposing sides of the frame 103. In aspects, the second support arm 707 can engage a second native leaflet 709, which may be substantially identical to the native leaflet 703, in substantially the same manner that the support arm 131 engages the native leaflet 703. As such, in aspects, the valve prosthesis 101 can be secured in place at the treatment location 701 by a plurality of support arms 131, 707 that engage and radially compress a plurality of native leaflets 703, 709. In aspects, the valve prosthesis 101 is not limited to comprising the two support arms 131, 707, but, rather, may comprise additional or fewer support arms. For example, a valve prosthesis 101 having three support arms may be employed advantageously for implantation in a native tricuspid valve such that each support arm corresponds exactly with a respective native leaflet and, thus, each support arm can be employed to hold an individual leaflet. In some aspects, in addition to providing an anchoring system for the valve prosthesis 101 to be placed in a native annulus, the valve prosthesis 101 and support arms 131, 707 may also hold native leaflets in a manner such that the native leaflets do not interfere with the function or operation of the replacement valve prosthesis 101, thereby improving performance of the replacement valve prosthesis 101

[0072] FIG. 8 illustrates a delivery apparatus 801 for delivering the valve prosthesis 101 to the treatment location 701. In aspects, the delivery apparatus 801 can comprise a first sheath 803, a second sheath 805, and a third sheath 807 that, together, can receive the valve prosthesis 101. For example, the first sheath 803 can comprise a first cavity 809, the second sheath 805 can comprise a second cavity 811, and the third sheath 807 can comprise a third cavity 813. The third sheath 807 can be positioned within the first cavity 809 of the first sheath 803, with the first sheath 803, the second sheath 805, the third sheath 807, and the valve prosthesis 101 extending substantially coaxially. In aspects, the first valve end 107 can be positioned within the third cavity 813, such that the third sheath 807 can receive the first valve end 107. A portion of the valve prosthesis 101 extending from the first valve end 107 to a central region of the valve prosthesis 101 and the support arm 131 can be received within the first cavity 809. In this way, the support arm 131 can be circumferentially surrounded by the first sheath 803. In aspects, a portion of the valve prosthesis 101 extending from the second valve end 109 to the central region of the valve prosthesis 101 can be received within the second cavity 811. In this way, the first sheath 803 and the second sheath 805 can abut and may be positioned end-to-end while surrounding and receiving the valve prosthesis 101 within the first cavity 809 and the second cavity 811. [0073] The valve prosthesis 101 can be placed within the delivery apparatus 801 while the valve prosthesis 101 and the delivery apparatus 801 are at an exterior of the patient’s vasculature. In aspects, the delivery apparatus 801, for example, the sheaths 803, 805, 807, can be attached to and controlled by an actuator, for example, a handle, to selectively move the sheaths 803, 805, 807 relative to the valve prosthesis 101. In aspects, the handle can comprise a push-pull actuator that may be attached or connected to an end of one or more of the sheaths 803, 805, 807. In aspects, the handle can comprise a rotatable knob such that, when the knob is rotated, the sheaths 803, 805, 807 may be independently moved or retracted, which can release the valve prosthesis 101 from the cavities of the sheaths 803, 805, 807. In aspects, the delivery apparatus 801 can comprise further structures for facilitating delivery of the valve prosthesis 101, for example, wires (e.g., guidewires), etc.

[0074] In aspects, the valve prosthesis 101 can comprise a first portion 817, a second portion 819, and a third portion 821. The first portion 817 may comprise a central region of the valve prosthesis 101 and may comprise the support arm 131. The second portion 819 may comprise a second end region extending from the second valve end 109 to the first portion 817. The third portion 821 can comprise a first end region extending from the first valve end 107 to the first portion 817. In this way, the first portion 817 can be spaced a first distance 823 from the first valve end 107 and a second distance 825 from the second valve end 109. In aspects, methods can comprise positioning the heart valve prosthesis 101 at the treatment location 701, with the heart valve prosthesis 101 comprising the frame 103 and the support arm 131 attached to the outer radial side of the frame 103. Positioning the heart valve prosthesis 101 can comprise moving the delivery apparatus 801 through the vasculature of a patient until the delivery apparatus 801 reaches the treatment location 701. In aspects, the first portion 817 may be positioned in the first sheath 803, the second portion 819 may be positioned in the second sheath 805, and the third portion 821 may be positioned in the third sheath 807.

[0075] It will be appreciated that, in aspects, the delivery apparatus 801 is not limited to comprising the three sheaths 803, 805, 807 as illustrated. Rather, in aspects, the delivery apparatus 801 can comprise two sheaths: the first sheath 803 and the second sheath 805. In this way, the first portion 817 and the third portion 821 can be positioned in the first cavity 809, and the second portion 819 can be positioned in the second cavity 811. As such, the first sheath 803 can receive the first portion 817 and the third portion 821 and can radially-compress the first portion 817 and the third portion 821, and the second sheath 805 can receive the third portion 821.

[0076] Referring to FIG. 9, in aspects, methods can comprise removing the first portion 817 of the heart valve prosthesis 101 from the first sheath 803. The first portion 817 of the heart valve prosthesis 101 can comprise the support arm 131 such that the support arm 131 moves radially outwardly from a radially-collapsed position while in the first sheath 803 to a radially-expanded position outside of the first sheath 803. In aspects, removing the first portion 817 of the heart valve prosthesis 101 from the first sheath 803 can comprise moving the first sheath 803 in a first movement direction 901. The first movement direction 901 may be away from the second sheath 805. By moving the first sheath 803 in the first movement direction 901, the first portion 817 comprising the support arm 131 may no longer be positioned within the first cavity 809 such that the support arm 131 can radially expand upon being removed from the first cavity 809. Accordingly, upon removing the first portion 817, the first valve end 107 can be positioned within the first sheath 803 (e.g., and the third sheath 807) and the second valve end 109 can be positioned within the second sheath 805. In aspects in which the delivery apparatus 801 comprises two sheaths (e.g., the first sheath 803 and the second sheath 805), the first valve end 107, the third portion 821, and at least some of the first portion 817 are positioned within the first sheath 803, and, in aspects, may contact an inner radial surface of the first sheath 803.

[0077] Referring to FIG. 10, in aspects, methods can comprise moving the heart valve prosthesis 101 such that the support arm 131 is located radially outwardly from the native leaflet 703 at the treatment location 701. Likewise, the second support arm 707 can be positioned radially outwardly from the second native leaflet 709. For example, moving the heart valve prosthesis 101 can comprise axially adjusting a position of the delivery apparatus 801 and, thus, the heart valve prosthesis 101, relative to the native leaflet 703. The native leaflet 703 can be in a similar position relative to the support arm 131 in FIG. 10 as illustrated in FIG. 7. Likewise, the second native leaflet 709 can be in a similar position relative to the second support arm 707 as illustrated in FIG. 7. In aspects, the support arms 131, 707 may be in contact with the outer radial sides of the native leaflets 703, 709. In this way, the valve prosthesis 101 may remain in the radially-compressed position (e.g., not expanded) while the support arms 131, 707 are in a radially-expanded position, thus allowing for the delivery apparatus 801 to move axially and adjust a position of the support arms 131, 707 relative to the native leaflets 703, 709 at the treatment location 701

[0078] Referring to FIG. 11, in aspects, methods can comprise removing the second portion 819 of the heart valve prosthesis 101 from the second sheath 805 such that the frame 103 moves from the radially-collapsed position to the radially-expanded position and the native leaflet 703 is positioned radially between, and in contact with, the frame 103 and the support arm 131. Though obstructed from view in FIG. 11, the second native leaflet 709 can similarly be positioned radially between, and in contact with, the frame 103 and the second support arm 707. For example, removing the second portion 819 of the heart valve prosthesis 101 from the second sheath 805 comprises moving the second sheath 805 in a second movement direction 1101 opposite the first movement direction 901. As mentioned above, the movement of the sheaths 803, 805, 807 in the movement directions 901, 1101 can be controlled by the handle (e.g., at an exterior of the patient’s vasculature), such that the handle can cause the sheaths 803, 805, 807 to move independently in the respective movement directions 901, 1101.

[0079] The second movement direction 1101 may be away from the first sheath 803. In this way, the second portion 819 of the valve prosthesis 101 and the second valve end 109 may be uncovered and not positioned within the second sheath 805. Accordingly, removing the second portion 819 can comprise removing the second valve end 109 from the second sheath 805. With the second portion 819 in the radially-expanded position, in aspects, the native leaflet 703 can be positioned between and in contact with the support arm 131 and the outer radial side of the frame 103. The support arm 131 can apply a force to the native leaflet 703 to bias the native leaflet 703 toward the frame 103 and secure the frame 103 relative to the native leaflet 703. Similarly, the second support arm 707 can apply a force to the second native leaflet 709 to bias the second native leaflet 709 toward the frame 103. In this way, by securing the frame 103, the valve prosthesis 101 is limited from moving out of position, for example, axially or by rotating, due to the engagement between the support arms 131, 707 and the native leaflets 703, 709. [0080] Referring to FIG. 12, in aspects, after removing the second portion 819, methods can comprise removing the third portion 821 of the heart valve prosthesis 101 from the first sheath 803 and the third sheath 807, with the third portion 821 comprising a first end region extending from the first valve end 107 to the first portion 817. For example, to remove the third portion 821, the first sheath 803 and the third sheath 807 can be moved in the first movement direction 901 away from the second sheath 805. Upon being removed from first sheath 803 and the third sheath 807, the third portion 821 can move from the radially-contracted position to the radially-expanded position. At this point, the valve prosthesis 101 may be in the radially-expanded position with the support arms 131, 707 engaging the native leaflets 703, 709. The delivery apparatus 801 can then be withdrawn and removed, for example, by moved and retracted in the first movement direction 901. The valve prosthesis 101 may remain in the illustrated and desired position at the treatment location 701 as the delivery apparatus 801 is withdrawn. In aspects in which the delivery apparatus 801 comprises two sheaths (e.g., the first sheath 803 and the second sheath 805), the first valve end 107, the third portion 821, and at least some of the first portion 817 are initially positioned in the first sheath 803 (e g., illustrated in FIG. 11) and may contact an inner radial surface of the first sheath 803. As illustrated in FIG. 12, the first sheath 803 can be moved in the first movement direction 901, thus allowing for the first valve end 107, the third portion 821, and the first portion 817 to be removed from the first sheath 803 and the heart valve prosthesis 101 can move tot eh radially-expanded position.

[0081] The support arms 131, 707 illustrated and described herein can provide several benefits. For example, the support arms 131, 707 can assist in securing the valve prosthesis 101 at the treatment location 701 by engaging the native leaflets 703, 709 and applying a radially-compressive force to the native leaflets 703, 709. In this way, the valve prosthesis 101 is limited from moving (e.g., axially, rotationally, etc.) from a desired position upon being positioned at the treatment location 701. In addition, the valve prosthesis 101, for example, the frame 103 and the valve sub-assembly 104, can accommodate the support arms 131, 707 without re-designing or altering a structure, dimension, or material of the frame 103 and the valve sub-assembly 104. That is, an existing frame 103 is capable of being attached to the support arms 131, 707. Further, the support arms 131, 707 can be modified based on characteristics of the patient, such as, for example, an anatomy of the patient. For example, the size of the patient’s native leaflets 703, 709 can be determined prior to positioning of the valve prosthesis 101. Based on the size of the patient’s native leaflets 703, 709, a size and/or shape of the support arms 131, 707 can be selected and attached to the frame 103. Further, the frame 103 can accommodate one support arm, two support arms, three support arms depending on the treatment location 701. In addition, in aspects, the support arms 131, 707 can be covered in a radiopaque material to further facilitate imaging the patient to ensure that the valve prosthesis 101 is positioned at a desired location. For example, prior to insertion of the valve prosthesis 101, a radiopaque material can be applied to the support arms 131, 707, for example, at the second end 135, such that imaging (e.g., fluoroscopy) can be conducted during delivery and deployment to monitor the position of the support arms 131, 707 relative to the native leaflets 703, 709.

[0082] 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 heart valve prosthesis comprising: an annular frame extending along a valve axis between a first valve end of the heart valve prosthesis and a second valve end of the heart valve prosthesis, the annular frame comprising a plurality of frame members and configured to be adjustable between a radially-collapsed position and a radially-expanded position; and a support arm extending between a first end and a second end along an arm axis that is substantially parallel to the valve axis, the first end comprising an attachment member comprising a wall surrounding a recess, a frame member of the plurality of frame members configured to be received within the recess to attach the support arm to an outer radial side of the annular frame, the second end extending adjacent to and detached from the outer radial side.

2. The heart valve prosthesis of claim 1, wherein the attachment member comprises a first segment and a second segment, the first segment spaced apart from the second segment and defining the recess between the first segment and the second segment.

3. The heart valve prosthesis of claim 2, wherein the first segment comprises a first wall and a second wall, the first wall defining a first angle relative to the second wall that is within a range from about 70 degrees to about 110 degrees, the first wall extending along a first plane and the second wall extending along a second plane.

4. The heart valve prosthesis of claim 3, wherein the second segment comprises a third wall and a fourth wall, the third wall defining a second angle relative to the fourth wall that is within a range from about 70 degrees to about 110 degrees, the third wall extending along a third plane that is substantially parallel to the first plane, and the fourth wall extending along the second plane.

5. The valve prosthesis valve of claim 4, wherein the second wall extends between a first end, which is attached to the first wall, and a second end, and wherein the fourth wall extends between a third end, which is attached to the third wall, and a fourth end, further wherein the second end and the fourth end are spaced a distance apart and define a gap between the second wall and the fourth wall.

6. The heart valve prosthesis of claim 5, wherein the distance is less than a width of the frame member received within the recess, the width measured along a width axis that is parallel to the second plane and intersects the first wall and the third wall.

7. The heart valve prosthesis of claim 1, wherein the support arm comprises a nitinol material.

8. The heart valve prosthesis of claim 1, wherein a native leaflet is positioned between the second end and the outer radial side of the frame.

9. The heart valve prosthesis of claim 9, wherein the support arm is spaced a separating distance apart from the outer radial side that is less than about 3 millimeters.

10. A heart valve prosthesis comprising: an annular frame extending along a valve axis between a first valve end of the heart valve prosthesis and a second valve end of the heart valve prosthesis, the annular frame comprising a plurality of frame members and configured to be adjustable between a radially-collapsed position and a radially-expanded position; and a support arm extending between a first end and a second end along an arm axis that is substantially parallel to the valve axis, the first end comprising: a first attachment member comprising a first wall surrounding a first recess, a first frame member of the plurality of frame members configured to be received within the first recess; and a second attachment member comprising a second wall surrounding a second recess, a second frame member of the plurality of frame members configured to be received within the second recess, the first attachment member spaced circumferentially apart from the second attachment member around the annular valve prosthesis such that the first attachment member and the second attachment member are configured to attach the support arm to an outer radial side of the annular frame; the support arm comprising an elongated body member extending non-linearly between the first attachment member and the second attachment member, the body member comprising a rounded shape at the second end that is adjacent to and detached from the outer radial side of the annular frame, wherein a separating distance separating the outer radial side from the support arm is non-constant between the first end and the second end.

11. The heart valve prosthesis of claim 10, wherein an attachment plane that is perpendicular to the valve axis intersects the first attachment member and the second attachment member.

12. The heart valve prosthesis of claim 10, wherein the support arm comprises a shape that substantially matches a shape of the outer radial side of the annular frame.

13. The heart valve prosthesis of claim 10, wherein the support arm comprises a nitinol material.

14. The heart valve prosthesis of claim 10, wherein a native leaflet is positioned between the second end and the outer radial side of the frame.