Patent Description:
A wide variety of intracorporeal medical devices have been developed for medical use, for example, surgical and/or intravascular use. Some of these devices include guidewires, catheters, medical device delivery systems (e.g., for stents, grafts, replacement valves, etc.), and the like. These devices are manufactured by any one of a variety of different manufacturing methods and may be used according to any one of a variety of methods. Of the known medical devices and methods, each has certain advantages and disadvantages. There is an ongoing need to provide alternative medical devices as well as alternative methods for manufacturing and/or using medical devices. <CIT> discloses a valve prosthesis and an implantation device utilizing movable claspers for positioning and anchoring the valve prosthesis.

The present invention pertains to a replacement heart valve as set forth in the appended claims. In accordance with the invention, the replacement heart valve implant defines a central longitudinal axis extending from an upstream end to a downstream end and comprises an expandable anchor member configured to shift between a delivery configuration and a deployed configuration. The expandable anchor member forms a plurality of crowns extending downstream. The implant further comprises a circumferential support member distinct from and attached to the expandable anchor member, at least a portion of the circumferential support member extending downstream of the expandable anchor member. One of the plurality of crowns overlaps at least a portion of the circumferential support member to define a commissure attachment location. The implant further comprises a plurality of valve leaflets secured to the expandable anchor member. The plurality of valve leaflets include a valve leaflet commissure movable from a first longitudinal position within the lumen of the expandable anchor member relative to the downstream end in the delivery configuration to a second longitudinal position within the lumen of the expandable anchor member relative to the downstream end in the deployed configuration. The valve leaflet commissure is attached to the expandable anchor member at the commissure attachment location in the deployed configuration.

While aspects of the disclosure are amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit aspects of the disclosure to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the scope of the disclosure.

The following description should be read with reference to the drawings, which are not necessarily to scale, wherein like reference numerals indicate like elements throughout the several views. The detailed description and drawings are intended to illustrate but not limit the claimed invention. Those skilled in the art will recognize that the various elements described and/or shown may be arranged in various combinations and configurations without departing from the scope of the disclosure. The detailed description and drawings illustrate example embodiments of the claimed invention.

The term "extent" may be understood to mean a greatest measurement of a stated or identified dimension, unless the extent or dimension in question is preceded by or identified as a "minimum", which may be understood to mean a smallest measurement of the stated or identified dimension. For example, "outer extent" may be understood to mean a maximum outer dimension, "radial extent" may be understood to mean a maximum radial dimension, "longitudinal extent" may be understood to mean a maximum longitudinal dimension, etc. Each instance of an "extent" may be different (e.g., axial, longitudinal, lateral, radial, circumferential, etc.) and will be apparent to the skilled person from the context of the individual usage. Generally, an "extent" may be considered a greatest possible dimension measured according to the intended usage, while a "minimum extent" may be considered a smallest possible dimension measured according to the intended usage. In some instances, an "extent" may generally be measured orthogonally within a plane and/or cross-section, but may be, as will be apparent from the particular context, measured differently - such as, but not limited to, angularly, radially, circumferentially (e.g., along an arc), etc..

The terms "monolithic" and "unitary" shall generally refer to an element or elements made from or consisting of a single structure or base unit/element. A monolithic and/or unitary element shall exclude structure and/or features made by assembling or otherwise joining multiple discrete elements together.

Diseases and/or medical conditions that impact the cardiovascular system are prevalent throughout the world. Some mammalian hearts (e.g., human, etc.) include four heart valves: a tricuspid valve, a pulmonary valve, an aortic valve, and a mitral valve. The purpose of the heart valves is to allow blood to flow through the heart and from the heart into the major blood vessels connected to the heart, such as the aorta and the pulmonary artery, for example. In a normally functioning heart valve, blood is permitted to pass or flow downstream through the heart valve (e.g., from an atrium to a ventricle, from a ventricle to an artery, etc.) when the heart valve is open, and when the heart valve is closed, blood is prevented from passing or flowing back upstream through the heart valve (e.g., from a ventricle to an atrium, etc.). Some relatively common medical conditions may include or be the result of inefficiency, ineffectiveness, or complete failure of one or more of the valves within the heart. Treatment of defective heart valves poses other challenges in that the treatment often requires the repair or outright replacement of the defective valve. Such therapies may be highly invasive to the patient. Disclosed herein are medical devices that may be used within a portion of the cardiovascular system in order to diagnose, treat, and/or repair the system.

At least some of the medical devices disclosed herein may include a replacement heart valve implant (e.g., a replacement aortic valve, a replacement mitral valve, etc.) and may reduce, treat, and/or prevent the occurrence of defects such as (but not limited to) regurgitation, leaflet prolapse, and/or valve stenosis. In addition, the devices disclosed herein may deliver the replacement heart valve implant percutaneously and, thus, may be much less invasive to the patient, although other surgical methods and approaches may also be used. The devices disclosed herein may also provide a number of additional desirable features and benefits as described in more detail below. For the purpose of this disclosure, the discussion below is directed toward a replacement aortic valve and will be so described in the interest of brevity. This, however, is not intended to be limiting as the skilled person will recognize that the following discussion may also apply to a replacement mitral valve or another replacement heart valve with no or minimal changes to the structure and/or scope of the disclosure.

<FIG> illustrates an example replacement heart valve delivery device <NUM> including a replacement heart valve implant <NUM> configured to be disposed within a native heart valve (e.g., a mitral valve, an aortic valve, etc.), wherein the replacement heart valve implant <NUM> may be disposed within a lumen of the replacement heart valve delivery device <NUM> in a delivery configuration for delivery to the native heart valve, where the replacement heart valve implant <NUM> may be shifted to a deployed configuration. In some embodiments, the replacement heart valve delivery device <NUM> may include a delivery sheath <NUM> having a lumen extending from a proximal portion and/or proximal end of the delivery sheath <NUM> to a distal end of the delivery sheath <NUM>. The replacement heart valve implant <NUM> may be disposed within the lumen of the delivery sheath <NUM> proximate the distal end of the delivery sheath <NUM> in the delivery configuration. In some embodiments, the replacement heart valve delivery device <NUM> may include a handle <NUM> disposed proximate the proximal end of the delivery sheath <NUM>.

The replacement heart valve delivery device <NUM> may include an elongate shaft <NUM> disposed within the lumen of the delivery sheath <NUM> and/or slidable with respect to the delivery sheath <NUM> within the lumen of the delivery sheath <NUM>. In some embodiments, the elongate shaft <NUM> may be a tubular structure having a lumen extending therethrough, the elongate shaft <NUM> may be a solid shaft, or the elongate shaft <NUM> may be a combination thereof. In some embodiments, the replacement heart valve delivery device <NUM> may include a plurality of elongate members <NUM> releasably connecting the replacement heart valve implant <NUM> to the elongate shaft <NUM> and/or the handle <NUM>. The plurality of elongate members <NUM> may extend distally from the elongate shaft <NUM> to the replacement heart valve implant <NUM>. In some embodiments, the plurality of elongate members <NUM> may be slidably disposed within and/or may extend slidably through the elongate shaft <NUM>.

In use, the elongate shaft <NUM> and/or the plurality of elongate members <NUM> may be used to move the replacement heart valve implant <NUM> with respect to the delivery sheath <NUM> of the replacement heart valve delivery device <NUM>. For example, the elongate shaft <NUM> and/or the plurality of elongate members <NUM> may be advanced distally within the lumen of the delivery sheath <NUM> to push the replacement heart valve implant <NUM> out the distal end of the delivery sheath <NUM> and/or the replacement heart valve delivery device <NUM> to deploy the replacement heart valve implant <NUM> within the native heart valve. Alternatively, the elongate shaft <NUM> and/or the plurality of elongate members <NUM> may be held in a fixed position relative to the replacement heart valve implant <NUM> and the delivery sheath <NUM> may be withdrawn proximally relative to the elongate shaft <NUM>, the plurality of elongate members <NUM>, and/or the replacement heart valve implant <NUM> to deploy the replacement heart valve implant <NUM> within the native heart valve. Some examples of suitable but non-limiting materials for the replacement heart valve delivery device <NUM>, the delivery sheath <NUM>, the elongate shaft <NUM>, the plurality of elongate members <NUM>, the handle <NUM>, and/or components or elements thereof, are described below.

<FIG> illustrate a replacement heart valve implant <NUM> in accordance with the invention in the delivery configuration (e.g., <FIG>, <FIG>) and the deployed configuration (e.g., <FIG>, <FIG>). The replacement heart valve implant <NUM> defines a central longitudinal axis <NUM> extending through a lumen of the replacement heart valve implant <NUM> from an upstream end <NUM> to a downstream end <NUM>. The replacement heart valve implant <NUM> includes an expandable anchor member <NUM> configured to shift between the delivery configuration and the deployed configuration. In the delivery configuration, the expandable anchor member <NUM> may be radially compressed and/or longitudinally elongated, while in the deployed configuration, the expandable anchor member <NUM> may be radially expanded and/or longitudinally shortened.

In some embodiments, the expandable anchor member <NUM> may comprise an expandable stent structure and/or framework. In some embodiments, the expandable anchor member <NUM> may comprise a self-expanding braided and/or woven mesh structure made up of one or more filaments disposed and/or interwoven circumferentially about the lumen of the expandable anchor member <NUM> and/or the replacement heart valve implant <NUM>. Non-self-expanding, mechanically-expandable, and/or assisted self-expanding expandable anchor members are also contemplated. In at least some embodiments, the expandable anchor member <NUM> may be formed as a unitary structure (e.g., formed from a single filament or strand of wire, cut from a single tubular member, etc.). Some examples of suitable but non-limiting materials for the replacement heart valve implant <NUM>, the expandable anchor member <NUM>, and/or components or elements thereof, are described below.

<FIG> illustrates some additional aspects of the expandable anchor member <NUM>, shown in the deployed configuration. In some embodiments, the expandable anchor member <NUM> may define a generally cylindrical outer surface in the deployed configuration. Other configurations are also possible - a generally elliptical outer surface, for example. In some embodiments, the expandable anchor member <NUM> may form a plurality of crowns <NUM> extending varying distances downstream from the upstream end <NUM>. Each of the plurality of crowns <NUM> may define a downstreammost extent <NUM> of that crown. The downstreammost extents <NUM> of the plurality of crowns <NUM> may extend varying distances downstream from the upstream end <NUM>. In some embodiments, the plurality of crowns <NUM> may comprise a plurality of commissure crowns <NUM>, a plurality of intermediate crowns <NUM>, and a plurality of anchor crowns <NUM>.

The example replacement heart valve implant <NUM> and/or the expandable anchor member <NUM> may be shown in the figures with a particular number or quantity of some features. However, other numbers and/or quantities of these features are also contemplated and may fall within the scope of the instant disclosure. In some embodiments, the plurality of commissure crowns <NUM> may include two commissure crowns <NUM>, three commissure crowns <NUM>, or another suitable number of commissure crowns <NUM>. Each of the plurality of intermediate crowns <NUM> may be disposed immediately adjacent the plurality of commissure crowns <NUM>, such that one commissure crown <NUM> is disposed between two intermediate crowns <NUM>. Accordingly, a pair of (e.g., two) intermediate crowns <NUM> may be disposed between two adjacent commissure crowns <NUM>. In some embodiments, the plurality of intermediate crowns <NUM> may include four (e.g., two pair of) intermediate crowns <NUM>, six (e.g., three pair of) intermediate crowns <NUM>, or another suitable number of intermediate crowns correlated to and/or determined by the plurality of commissure crowns <NUM>. The plurality of anchor crowns <NUM> may be disposed between each pair of intermediate crowns <NUM> disposed between two adjacent commissure crowns <NUM>. In some embodiments, the plurality of anchor crowns <NUM> may include more than one discrete group of anchor crowns <NUM>, wherein each discrete group of anchor crowns <NUM> is disposed between the pair of intermediate crowns <NUM> disposed between two adjacent commissure crowns <NUM>. For example, as will become apparent, in a tricuspid or three-leaflet configuration, the plurality of anchor crowns <NUM> may include three discrete groups of anchor crowns <NUM>.

As seen in <FIG>, the plurality of commissure crowns <NUM> may extend a first distance D1 downstream from the upstream end <NUM> in the delivery configuration and/or the deployed configuration. The plurality of intermediate crowns <NUM> may extend a second distance D2 downstream from the upstream end <NUM> in the delivery configuration and/or the deployed configuration. The plurality of anchor crowns <NUM> may extend a third distance D3 downstream from the upstream end <NUM> in the delivery configuration and/or the deployed configuration. In most embodiments, the first distance D1 is greater than the second distance D2 and the second distance D2 is greater than the third distance D3. Similarly, the first distance D1 is greater than the third distance D3. Other configurations may also be possible. For example, in one alternative, the second distance D2 and the third distance D3 may be substantially identical. In yet another alternative, some of the plurality of anchor crowns <NUM> may extend a varying distance downstream from the upstream end <NUM> in the delivery configuration and/or the deployed configuration (e.g., the third distance D3 may vary within the plurality of anchor crowns <NUM> and/or within a discrete group of anchor crowns <NUM>).

Turning back to <FIG>, the replacement heart valve implant <NUM> in accordance with the invention includes a circumferential support member <NUM> secured and/or attached to the expandable anchor member <NUM>. The circumferential support member <NUM> is distinct and/or separately-formed from the expandable anchor member <NUM>. In some embodiments, the circumferential support member <NUM> may be secured and/or attached to the expandable anchor member <NUM> using sutures, adhesive bonding, welding, brazing, or other suitable means. In one alternative example, the circumferential support member <NUM> may be unitary and/or integrally-formed with the expandable anchor member <NUM>.

At least a portion of the circumferential support member <NUM> extends downstream of the expandable anchor member <NUM> (e.g., downstream of the downstreammost extent of the plurality of commissure crowns <NUM>, and/or may extend a distance downstream from the upstream end <NUM> in the delivery configuration and/or the deployed configuration greater than the first distance D1), as most easily seen in <FIG> for example. In some embodiments, the circumferential support member <NUM> may be directly attached to at least two of the plurality of crowns <NUM> (e.g., at least two of the plurality of commissure crowns <NUM>, etc.). In some embodiments, the circumferential support member <NUM> may be attached to the expandable anchor member <NUM> at about the third distance D3 downstream from the upstream end <NUM> in the delivery configuration and/or the deployed configuration. In some embodiments, the circumferential support member <NUM> may be attached to the expandable anchor member <NUM> at about the first distance D1 downstream from the upstream end <NUM> in the delivery configuration and/or the deployed configuration. In some embodiments, the at least two of the plurality of crowns <NUM> (e.g., at least two of the plurality of commissure crowns <NUM>, etc.) to which the circumferential support member <NUM> is directly attached extend further downstream from the upstream end <NUM> in the delivery configuration and/or the deployed configuration than any immediately adjacent crowns <NUM> (e.g., the plurality of intermediate crowns <NUM>, etc.) - for example, at a distance greater than the second distance D2.

In accordance with the invention, one of the plurality of crowns <NUM> longitudinally and/or circumferentially overlaps at least a portion of the circumferential support member <NUM> to define a commissure attachment location <NUM> in the delivery configuration and/or the deployed configuration. In some embodiments, the circumferential support member <NUM> may be directly attached to the expandable anchor member <NUM> at the commissure attachment location <NUM> in the delivery configuration and/or the deployed configuration. In some embodiments, more than one of the plurality of crowns <NUM> longitudinally and/or circumferentially overlaps at least a portion of the circumferential support member <NUM> to define more than one commissure attachment location <NUM> in the delivery configuration and/or the deployed configuration. In some embodiments, the circumferential support member <NUM> may be directly attached to the expandable anchor member <NUM> at each of the commissure attachment locations <NUM> in the delivery configuration and/or the deployed configuration.

In some embodiments, at least a portion of the circumferential support member <NUM> extends radially outward of and/or from the expandable anchor member <NUM> in the deployed configuration, as most easily seen in <FIG>. Also shown in <FIG>, but omitted from the other figures in the interest of clarity, the replacement heart valve implant <NUM> includes a plurality of valve leaflets <NUM> disposed within the lumen of the replacement heart valve implant <NUM> and secured to the expandable anchor member <NUM>. In some embodiments, the plurality of valve leaflets <NUM> may be attached and/or secured to the expandable anchor member <NUM> at a plurality of locations within the lumen of the replacement heart valve implant <NUM> and/or the expandable anchor member <NUM>. In some embodiments, the plurality of valve leaflets <NUM> may be attached and/or secured to the expandable anchor member <NUM> using sutures, adhesives, or other suitable means.

In some embodiments, the plurality of valve leaflets <NUM> may include two leaflets, three leaflets, four leaflets, etc. as desired. The plurality of valve leaflets <NUM> of the replacement heart valve implant <NUM> may be configured to move between an open configuration permitting antegrade fluid flow through the replacement heart valve implant <NUM> and/or the lumen of the replacement heart valve implant <NUM> and/or the expandable anchor member <NUM>, and a closed configuration preventing retrograde fluid flow through the replacement heart valve implant <NUM> and/or the lumen of the replacement heart valve implant <NUM> and/or the expandable anchor member <NUM>. The plurality of valve leaflets <NUM> may each have a free edge, wherein the free edges of the plurality of valve leaflets <NUM> coapt within the replacement heart valve implant <NUM>, the expandable anchor member <NUM>, and/or the lumen extending through the expandable anchor member <NUM> in the closed configuration. Some examples of suitable but non-limiting materials for the plurality of valve leaflets <NUM> may include bovine pericardial, polymeric materials, or other suitably flexible biocompatible materials.

The plurality of valve leaflets <NUM> include in accordance with the invention a valve leaflet commissure <NUM> movable from a first longitudinal position within the lumen of the replacement heart valve implant <NUM> and/or the expandable anchor member <NUM> relative to the downstream end <NUM> in the delivery configuration, as seen in <FIG>, to a second longitudinal position within the lumen of the replacement heart valve implant <NUM> and/or the expandable anchor member <NUM> relative to the downstream end <NUM> in the deployed configuration, as seen in <FIG>. Further description regarding this movement is provided below. In some embodiments, the plurality of valve leaflets <NUM> may include more than one valve leaflet commissure <NUM>. For example, each adjacent pair of valve leaflets <NUM> may form and/or define one valve leaflet commissure <NUM>. Therefore, the number of valve leaflet commissures <NUM> may be directly related to the number of valve leaflets <NUM> (e.g., three valve leaflets <NUM> form and/or define three valve leaflet commissures <NUM>, two valve leaflets <NUM> form and/or define two valve leaflet commissures <NUM>, etc.), as seen in <FIG>.

Turning back to <FIG>, in some embodiments, the circumferential support member <NUM> may include a plurality of lobes <NUM> extending circumferentially around the central longitudinal axis <NUM>, each lobe <NUM> corresponding to one of the plurality of valve leaflets <NUM> and/or positioned opposite one of the plurality of valve leaflets <NUM> with respect to the expandable anchor member <NUM>. The plurality of lobes <NUM> may each extend radially outward from the expandable anchor member <NUM>. In some embodiments, the plurality of lobes <NUM> may each be positioned against and/or proximate the outer surface of the expandable anchor member <NUM> in the delivery configuration, as seen in <FIG> for example. The plurality of lobes <NUM> may each extend radially outward from, and may be radially spaced away from, the outer surface of the expandable anchor member <NUM> in the deployed configuration, as seen in <FIG> for example. The circumferential support member <NUM> may include a longitudinal portion <NUM> extending toward the upstream end <NUM>, the longitudinal portion <NUM> being disposed between circumferentially adjacent lobes <NUM> of the plurality of lobes <NUM>. In some embodiments, the circumferential support member <NUM> may include a plurality of longitudinal portions <NUM> corresponding to the plurality of lobes <NUM>, each longitudinal portion <NUM> being disposed between two circumferentially adjacent lobes <NUM> of the plurality of lobes <NUM>. In some embodiments, the and/or each longitudinal portion <NUM> may correspond to and/or at least partially define the commissure attachment location(s) <NUM>. Each lobe <NUM> adjacent the commissure attachment location(s) <NUM> may extend toward the upstream end <NUM> and/or radially outward from the commissure attachment location(s) <NUM>.

In the deployed configuration, at least a portion of the circumferential support member <NUM> extends radially outward from the expandable anchor member <NUM>, upstream and/or toward the upstream end <NUM> from the plurality of commissure crowns <NUM>, and reaches its upstreammost extent (e.g., the position or extent longitudinally closest to the upstream end <NUM> and/or farthest from the downstream end <NUM>) proximate the plurality of anchor crowns <NUM>. For example, as seen in the deployed configuration illustrated in <FIG>, the upstreammost extent of at least a portion of the circumferential support member <NUM> is proximate the plurality of anchor crowns <NUM>. In some embodiments, the upstreammost extent of the circumferential support member <NUM> may be defined by the longitudinal portion(s) <NUM>. In some embodiments, the upstreammost extent of the circumferential support member <NUM> may be defined by one or more of the plurality of lobes <NUM>.

Additionally, in the deployed configuration, the circumferential support member <NUM> may approximate a path around the replacement heart valve implant <NUM> and/or the central longitudinal axis <NUM> following the longitudinal position of the downstreammost extents of the plurality of crowns <NUM> (e.g., the plurality of commissure crowns <NUM>, the plurality of intermediate crowns <NUM>, and/or the plurality of anchor crowns <NUM>) along a common radius from the central longitudinal axis <NUM>. For example, when viewed radially outwardly from the central longitudinal axis <NUM>, as the view is rotated on the central longitudinal axis <NUM> (e.g., when turning as to produce a <NUM>-degree view) the path of the circumferential support member <NUM> may generally follow, mimic, and/or approximate a path connecting, following, and/or along the downstreammost extents of the plurality of crowns <NUM> (e.g., the plurality of commissure crowns <NUM>, the plurality of intermediate crowns <NUM>, and/or the plurality of anchor crowns <NUM>). Some examples of suitable but non-limiting materials for the circumferential support member <NUM>, the plurality of lobes <NUM>, the longitudinal portion(s) <NUM>, and/or components or elements thereof, are described below.

In some embodiments, the replacement heart valve implant <NUM> may include a seal member <NUM> disposed on and/or around at least a portion of the outer surface of the expandable anchor member <NUM>. In some embodiments, the seal member <NUM> may be coupled and/or secured to the expandable anchor member <NUM> and/or the plurality of valve leaflets <NUM>. In some embodiments, a downstream edge <NUM> of the seal member <NUM> may follow the downstreammost extents of the plurality of crowns <NUM> (e.g., the plurality of commissure crowns <NUM>, the plurality of intermediate crowns <NUM>, and/or the plurality of anchor crowns <NUM>). The seal member <NUM> may be sufficiently flexible and/or pliable to conform to and/or around native valve leaflets and/or the native heart valve in the deployed configuration, thereby sealing an exterior of the replacement heart valve implant <NUM> and/or the expandable anchor member <NUM> within and/or against the native heart valve and/or the native valve leaflets and preventing leakage around the replacement heart valve implant <NUM> and/or the expandable anchor member <NUM>.

In some embodiments, the seal member <NUM> may include a plurality of layers of polymeric material. Some suitable polymeric materials may include, but are not necessarily limited to, polycarbonate, polyurethane, polyamide, polyether block amide, polyethylene, polyethylene terephthalate, polypropylene, polyvinyl chloride, polytetrafluoroethylene, polysulfone, and copolymers, blends, mixtures or combinations thereof. Other suitable polymeric materials are also contemplated, some of which are discussed below.

As briefly discussed above, when the replacement heart valve implant <NUM> and/or the expandable anchor member <NUM> is shifted from the delivery configuration to the deployed configuration, the valve leaflet commissure(s) <NUM> moves from the first longitudinal position relative to the downstream end <NUM> in the delivery configuration (e.g., <FIG>) to the second longitudinal position relative to the downstream end <NUM> in the deployed configuration (e.g., <FIG>). As seen in <FIG>, the valve leaflet commissure(s) <NUM> may be releasably connected to the plurality of elongate members <NUM> (of the replacement heart valve delivery device <NUM>). In some embodiments, as the replacement heart valve implant <NUM> is deployed, the valve leaflet commissure(s) <NUM> may be pulled toward the commissure attachment location(s) <NUM>, which may be held in a fixed position, or the commissure attachment location(s) <NUM> may be pushed toward the valve leaflet commissure(s) <NUM>, which may be held in a fixed position. In some embodiments, the valve leaflet commissure(s) <NUM> may be pulled toward the commissure attachment location(s) <NUM> and the commissure attachment location(s) <NUM> may be pushed toward the valve leaflet commissure(s) <NUM>, either in sequence or simultaneously. The valve leaflet commissure(s) <NUM> is in accordance with the invention attached to the expandable anchor member <NUM> at the commissure attachment location(s) <NUM> in the deployed configuration. The valve leaflet commissure(s) <NUM> may also be attached to the expandable anchor member <NUM> at the upstream end <NUM> in the delivery configuration and in the deployed configuration, using a suture for example.

Turning now to <FIG>, in some embodiments, the replacement heart valve implant <NUM> may further comprise a fabric element <NUM> overlapping the commissure attachment location(s) <NUM> (only one instance of which is shown/discussed in the interest of brevity and/or clarity). In some embodiments, the fabric element <NUM> may be disposed over the outer surface of the expandable anchor member <NUM>, an inner surface of the expandable anchor member <NUM>, an outer surface of the circumferential support member <NUM>, an inner surface of the circumferential support member <NUM>, and/or combinations thereof.

In some embodiments, the fabric element <NUM> may be wrapped around one of the plurality of crowns <NUM> (e.g., the commissure crowns <NUM>, the intermediate crowns <NUM>, the anchor crowns <NUM>) and the portion of the circumferential support member <NUM> overlapped by that crown. For example, in some embodiments, the commissure crown(s) <NUM> may longitudinally and/or circumferentially overlap at least a portion of the circumferential support member <NUM> (e.g., the longitudinal portion(s) <NUM>), and the fabric element <NUM> may be wrapped around the and/or each commissure crown <NUM> and the corresponding longitudinal portion <NUM> of the circumferential support member <NUM>.

In some embodiments, the fabric element <NUM> may extend from the commissure attachment location(s) <NUM> upstream and/or toward the upstream end <NUM> to each immediately adjacent crown <NUM>. For example, in some embodiments, the fabric element <NUM> may extend from the commissure attachment location(s) <NUM> (and/or the commissure crown <NUM> corresponding thereto) upstream and/or toward the upstream end <NUM> to each immediately adjacent intermediate crown <NUM>. A shape of the fabric element <NUM> may generally correspond to and/or align with the circumferential support member <NUM>, as seen in <FIG> for example. The fabric element <NUM> may provide additional sealing around the replacement heart valve implant <NUM> in the deployed configuration within the native heart valve, may provide and/or improve protection from abrasion of the components of the replacement heart valve implant <NUM> against the native anatomy, and/or may reduce embolization and/or thrombus formation, among other benefits. Some examples of suitable but non-limiting materials for the fabric element <NUM>, and/or components or elements thereof, are described below.

The materials that can be used for the various components of the replacement heart valve delivery device <NUM>, the replacement heart valve implant <NUM>, the expandable anchor member <NUM>, the circumferential support member <NUM>, the seal member <NUM>, the fabric element <NUM>, etc. (and/or other systems or components disclosed herein) and the various elements thereof disclosed herein may include those commonly associated with medical devices. For simplicity purposes, the following discussion makes reference to the replacement heart valve delivery device <NUM>, the replacement heart valve implant <NUM>, the expandable anchor member <NUM>, the circumferential support member <NUM>, the seal member <NUM>, the fabric element <NUM>, etc. However, this is not intended to limit the devices and methods described herein, as the discussion may be applied to other elements, members, components, or devices disclosed herein, such as, but not limited to, the delivery sheath <NUM>, the elongate shaft <NUM>, the plurality of elongate members <NUM>, the handle <NUM>, the plurality of crowns <NUM>, the plurality of lobes <NUM>, the longitudinal portion(s) <NUM>, and/or elements or components thereof.

In some embodiments, the replacement heart valve delivery device <NUM>, the replacement heart valve implant <NUM>, the expandable anchor member <NUM>, the circumferential support member <NUM>, the seal member <NUM>, the fabric element <NUM>, etc., and/or components thereof may be made from a metal, metal alloy, polymer (some examples of which are disclosed below), a metal-polymer composite, ceramics, combinations thereof, and the like, or other suitable material. Some examples of suitable metals and metal alloys include stainless steel, such as 444V, <NUM>, and 314LV stainless steel; mild steel; nickel-titanium alloy such as linear-elastic and/or super-elastic nitinol; other nickel alloys such as nickel-chromium-molybdenum alloys (e.g., UNS: N06625 such as INCONEL® <NUM>, UNS: N06022 such as HASTELLOY® C-<NUM>®, UNS: N10276 such as HASTELLOY® C276®, other HASTELLOY® alloys, and the like), nickel-copper alloys (e.g., UNS: N04400 such as MONEL® <NUM>, NICKELVAC® <NUM>, NICORROS® <NUM>, and the like), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R44035 such as MP35-N® and the like), nickel-molybdenum alloys (e.g., UNS: N10665 such as HASTELLOY® ALLOY B2®), other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten or tungsten alloys, and the like; cobalt-chromium alloys; cobalt-chromium-molybdenum alloys (e.g., UNS: R44003 such as ELGILOY®, PHYNOX®, and the like); platinum enriched stainless steel; titanium; platinum; palladium; gold; combinations thereof; and the like; or any other suitable material.

In at least some embodiments, portions or all of the replacement heart valve delivery device <NUM>, the replacement heart valve implant <NUM>, the expandable anchor member <NUM>, the circumferential support member <NUM>, the seal member <NUM>, the fabric element <NUM>, etc., and/or components thereof, may also be doped with, made of, or otherwise include a radiopaque material. Radiopaque materials are understood to be materials capable of producing a relatively bright image on a fluoroscopy screen or another imaging technique during a medical procedure. This relatively bright image aids a user in determining the location of the replacement heart valve delivery device <NUM>, the replacement heart valve implant <NUM>, the expandable anchor member <NUM>, the circumferential support member <NUM>, the seal member <NUM>, the fabric element <NUM>, etc. Some examples of radiopaque materials can include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloy, polymer material loaded with a radiopaque filler, and the like. Additionally, other radiopaque marker bands and/or coils may also be incorporated into the design of the replacement heart valve delivery device <NUM>, the replacement heart valve implant <NUM>, the expandable anchor member <NUM>, the circumferential support member <NUM>, the seal member <NUM>, the fabric element <NUM>, etc. to achieve the same result.

In some embodiments, a degree of Magnetic Resonance Imaging (MRI) compatibility is imparted into the replacement heart valve delivery device <NUM>, the replacement heart valve implant <NUM>, the expandable anchor member <NUM>, the circumferential support member <NUM>, the seal member <NUM>, the fabric element <NUM>, etc. For example, the replacement heart valve delivery device <NUM>, the replacement heart valve implant <NUM>, the expandable anchor member <NUM>, the circumferential support member <NUM>, the seal member <NUM>, the fabric element <NUM>, etc., and/or components or portions thereof, may be made of a material that does not substantially distort the image and create substantial artifacts (e.g., gaps in the image). Certain ferromagnetic materials, for example, may not be suitable because they may create artifacts in an MRI image. The replacement heart valve delivery device <NUM>, the replacement heart valve implant <NUM>, the expandable anchor member <NUM>, the circumferential support member <NUM>, the seal member <NUM>, the fabric element <NUM>, etc., or portions thereof, may also be made from a material that the MRI machine can image. Some materials that exhibit these characteristics include, for example, tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS: R44003 such as ELGILOY®, PHYNOX®, and the like), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R44035 such as MP35-N® and the like), nitinol, and the like, and others.

In some embodiments, the replacement heart valve delivery device <NUM>, the replacement heart valve implant <NUM>, the expandable anchor member <NUM>, the circumferential support member <NUM>, the seal member <NUM>, the fabric element <NUM>, etc., and/or portions thereof, may be made from or include a polymer or other suitable material. Some examples of suitable polymers may include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, for example, DELRIN® available from DuPont), polyether block ester, polyurethane (for example, Polyurethane 85A), polypropylene (PP), polyvinylchloride (PVC), polyether-ester (for example, ARNITEL® available from DSM Engineering Plastics), ether or ester based copolymers (for example, butylene/poly(alkylene ether) phthalate and/or other polyester elastomers such as HYTREL® available from DuPont), polyamide (for example, DURETHAN® available from Bayer or CRISTAMID® available from Elf Atochem), elastomeric polyamides, block polyamide/ethers, polyether block amide (PEBA, for example available under the trade name PEBAX®), ethylene vinyl acetate copolymers (EVA), silicones, polyethylene (PE), Marlex high-density polyethylene, Marlex low-density polyethylene, linear low density polyethylene (for example REXELL®), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), poly paraphenylene terephthalamide (for example, KEVLAR®), polysulfone, nylon, nylon-<NUM> (such as GRILAMID® available from EMS American Grilon), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefin, polystyrene, epoxy, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (for example, SIBS and/or SIBS 50A), polycarbonates, ionomers, polyurethane silicone copolymers (for example, ElastEon® from Aortech Biomaterials or ChronoSil® from AdvanSource Biomaterials), biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers thereof, polymer/metal composites, and the like. In some embodiments, the sheath can be blended with a liquid crystal polymer (LCP). For example, the mixture can contain up to about <NUM> percent LCP.

In some embodiments, the replacement heart valve delivery device <NUM>, the replacement heart valve implant <NUM>, the expandable anchor member <NUM>, the circumferential support member <NUM>, the seal member <NUM>, the fabric element <NUM>, etc. may include a textile material. Some examples of suitable textile materials may include synthetic yarns that may be flat, shaped, twisted, textured, pre-shrunk or un-shrunk. Synthetic biocompatible yarns suitable for use in the present invention include, but are not limited to, polyesters, including polyethylene terephthalate (PET) polyesters, polypropylenes, polyethylenes, polyurethanes, polyolefins, polyvinyls, polymethylacetates, polyamides, naphthalene dicarboxylene derivatives, natural silk, and polytetrafluoroethylenes. Moreover, at least one of the synthetic yarns may be a metallic yarn or a glass or ceramic yarn or fiber. Useful metallic yarns include those yarns made from or containing stainless steel, platinum, gold, titanium, tantalum or a Ni-Co-Cr-based alloy. The yarns may further include carbon, glass or ceramic fibers. Desirably, the yarns are made from thermoplastic materials including, but not limited to, polyesters, polypropylenes, polyethylenes, polyurethanes, polynaphthalenes, polytetrafluoroethylenes, and the like. The yarns may be of the multifilament, monofilament, or spun-types. The type and denier of the yarn chosen may be selected in a manner which forms a biocompatible and implantable prosthesis and, more particularly, a vascular structure having desirable properties.

In some embodiments, the replacement heart valve delivery device <NUM>, the replacement heart valve implant <NUM>, the expandable anchor member <NUM>, the circumferential support member <NUM>, the seal member <NUM>, the fabric element <NUM>, etc. may include and/or be treated with a suitable therapeutic agent. Some examples of suitable therapeutic agents may include anti-thrombogenic agents (such as heparin, heparin derivatives, urokinase, and PPack (dextrophenylalanine proline arginine chloromethylketone)); anti-proliferative agents (such as enoxaparin, angiopeptin, monoclonal antibodies capable of blocking smooth muscle cell proliferation, hirudin, and acetylsalicylic acid); anti-inflammatory agents (such as dexamethasone, prednisolone, corticosterone, budesonide, estrogen, sulfasalazine, and mesalamine); antineoplastic/antiproliferative/anti-mitotic agents (such as paclitaxel, <NUM>-fluorouracil, cisplatin, vinblastine, vincristine, epothilones, endostatin, angiostatin and thymidine kinase inhibitors); anesthetic agents (such as lidocaine, bupivacaine, and ropivacaine); anti-coagulants (such as D-Phe-Pro-Arg chloromethyl keton, an RGD peptide-containing compound, heparin, anti-thrombin compounds, platelet receptor antagonists, anti-thrombin antibodies, anti-platelet receptor antibodies, aspirin, prostaglandin inhibitors, platelet inhibitors, and tick antiplatelet peptides); vascular cell growth promoters (such as growth factor inhibitors, growth factor receptor antagonists, transcriptional activators, and translational promoters); vascular cell growth inhibitors (such as growth factor inhibitors, growth factor receptor antagonists, transcriptional repressors, translational repressors, replication inhibitors, inhibitory antibodies, antibodies directed against growth factors, bifunctional molecules consisting of a growth factor and a cytotoxin, bifunctional molecules consisting of an antibody and a cytotoxin); cholesterol-lowering agents; vasodilating agents; and agents which interfere with endogenous vascoactive mechanisms.

Claim 1:
A replacement heart valve implant (<NUM>) defining a central longitudinal axis (<NUM>) extending from an upstream end (<NUM>) to a downstream end (<NUM>), comprising:
an expandable anchor member (<NUM>) configured to shift between a delivery configuration and a deployed configuration, wherein the expandable anchor member (<NUM>) forms a plurality of crowns (<NUM>) extending downstream;
a circumferential support member (<NUM>) distinct from and attached to the expandable anchor member (<NUM>), at least a portion of the circumferential support member (<NUM>) extending downstream of the expandable anchor member (<NUM>), wherein one of the plurality of crowns (<NUM>) overlaps at least a portion of the circumferential support member (<NUM>) to define a commissure attachment location (<NUM>); characterized by
a plurality of valve leaflets (<NUM>) secured to the expandable anchor member (<NUM>), the plurality of valve leaflets (<NUM>) including a valve leaflet commissure (<NUM>) movable from a first longitudinal position within the lumen of the expandable anchor member (<NUM>) relative to the downstream end (<NUM>) in the delivery configuration to a second longitudinal position within the lumen of the expandable anchor member (<NUM>) relative to the downstream end (<NUM>) in the deployed configuration, wherein the valve leaflet commissure (<NUM>) is attached to the expandable anchor member (<NUM>) at the commissure attachment location (<NUM>) in the deployed configuration.