Cross-Reference To Related Applications

This application claims the benefit of priority under 35 U. S.C. § 119 to U. S. Provisional Application Serial No. 62/516,804, filed June 8, 2017, the entirety of which is incorporated herein by reference.

Technical Field

The present disclosure pertains to medical devices, and methods for manufacturing and/or using medical devices. More particularly, the present disclosure pertains to a replacement heart valve implant and/or components thereof.

Background

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.

Summary

In a first aspect, a replacement heart valve implant defining a central longitudinal axis extending from an upstream end to a downstream end may comprise an expandable anchor member configured to shift between a delivery configuration and a deployed configuration, 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, and a plurality of valve leaflets secured to the expandable anchor member. The plurality of valve leaflets may include a valve leaflet commissure movable from a first longitudinal position relative to the downstream end in the delivery configuration to a second longitudinal position relative to the downstream end in the deployed configuration.

In addition or alternatively, and in a second aspect, at least a portion of the circumferential support member extends radially outward of the expandable anchor member in the deployed configuration.

In addition or alternatively, and in a third aspect, the circumferential support member includes a plurality of lobes, each lobe corresponding to one of the plurality of valve leaflets.

In addition or alternatively, and in a fourth aspect, the circumferential support member includes a longitudinal portion extending toward the upstream end disposed between circumferentially adjacent lobes of the plurality of lobes.

In addition or alternatively, and in a fifth aspect, the expandable anchor member forms a plurality of crowns extending downstream, each crown defining a downstreammost extent of that crown. The downstreammost extents of the plurality of crowns may extend varying distances from the upstream end.

In addition or alternatively, and in a sixth aspect, further including a seal member disposed around the expandable anchor member, wherein a downstream edge of the seal member follows the downstreammost extents of the plurality of crowns.

In addition or alternatively, and in a seventh aspect, the circumferential support member is directly attached to at least two of the plurality of crowns.

In addition or alternatively, and in an eighth aspect, the at least two of the plurality of crowns to which the circumferential support member is directly attached extend further downstream than any immediately adjacent crowns.

In addition or alternatively, and in a ninth aspect, a replacement heart valve implant defining a central longitudinal axis extending from an upstream end to a downstream end may comprise an expandable anchor member configured to shift between a delivery configuration and a deployed configuration, the expandable anchor member forming a plurality of crowns extending varying distances downstream from the upstream end; a circumferential support member secured to the expandable anchor member, at least a portion of the circumferential support member extending downstream of the expandable anchor member; and a plurality of valve leaflets secured to the expandable anchor member. The plurality of valve leaflets may include a valve leaflet commissure movable from a first longitudinal position relative to the downstream end in the delivery configuration to a second longitudinal position relative to the downstream end in the deployed configuration. One of the plurality of crowns may overlap at least a portion of the circumferential support member to define a commissure attachment location, the circumferential support member being directly attached to the expandable anchor member at the commissure attachment location.

In addition or alternatively, and in a tenth aspect, the valve leaflet commissure is attached to the expandable anchor member at the commissure attachment location in the deployed configuration.

In addition or alternatively, and in an eleventh aspect, more than one of the plurality of crowns overlaps at least a portion of the circumferential support member to define more than one commissure attachment location, the circumferential support member being directly attached to the expandable anchor member at each of the commissure attachment locations.

In addition or alternatively, and in a twelfth aspect, further comprising a fabric element overlapping the commissure attachment location.

In addition or alternatively, and in a thirteenth aspect, the fabric element is wrapped around the crown and the portion of the circumferential support member overlapped by the crown.

In addition or alternatively, and in a fourteenth aspect, the fabric element extends from the commissure attachment location upstream to each immediately adjacent crown.

In addition or alternatively, and in a fifteenth aspect, the circumferential support member includes a plurality of lobes, each lobe corresponding to one of the plurality of valve leaflets, and each lobe adjacent the commissure attachment location extending upstream and radially outward from the commissure attachment location.

In addition or alternatively, and in a sixteenth aspect, a replacement heart valve implant defining a central longitudinal axis extending from an upstream end to a downstream end may comprise an expandable anchor member configured to shift between a delivery configuration and a deployed configuration, a circumferential support member attached to the expandable anchor member, at least a portion of the circumferential support member extending downstream of the expandable anchor member, and a plurality of valve leaflets secured to the expandable anchor member. The expandable anchor member may form a plurality of crowns extending downstream, comprising a plurality of commissure crowns, a plurality of intermediate crowns, each disposed immediately adjacent the plurality of commissure crowns such that one commissure crown is disposed between two intermediate crowns, and a plurality of anchor crowns disposed between each pair of intermediate crowns disposed between two commissure crowns.

In addition or alternatively, and in a seventeenth aspect, the plurality of commissure crowns extends a first distance downstream from the upstream end, the plurality of intermediate crowns extends a second distance downstream from the upstream end, and the plurality of anchor crowns extends a third distance downstream from the upstream end. The first distance may be greater than the second distance and the second distance may be greater than the third distance.

In addition or alternatively, and in an eighteenth aspect, the circumferential support member is attached to the expandable anchor member at about the third distance downstream from the upstream end.

In addition or alternatively, and in a nineteenth aspect, the circumferential support member is further attached to the expandable anchor member at about the first distance downstream from the upstream end.

In addition or alternatively, and in a twentieth aspect, in the deployed configuration, at least a portion of the circumferential support member extends radially outward from the expandable anchor member, upstream from the plurality of commissure crowns, and reaches its upstreammost extent proximate the plurality of anchor crowns.

The above summary of some embodiments, aspects, and/or examples is not intended to describe each embodiment or every implementation of the present disclosure. The figures and the detailed description which follows more particularly exemplify these embodiments.

Brief Description of the Drawings

The disclosure may be more completely understood in consideration of the following detailed description of various embodiments in connection with the accompanying drawings, in which:

FIG. 1 illustrates an example replacement heart valve delivery device;

FIG. 2 illustrates an example replacement heart valve implant in a delivery configuration;

FIG. 3 illustrates the example replacement heart valve implant of FIG. 2 in a deployed configuration; FIG. 4 is a side view of the example replacement heart valve implant of FIG. 2 in the deployed configuration;

FIG. 5 is a top view of the example replacement heart valve implant of FIG. 2 in the deployed configuration;

FIG. 6 is a partial section view illustrating aspects of the example replacement heart valve implant shown in FIG. 2;

FIG. 7 is a partial section view illustrating aspects of the example replacement heart valve implant shown in FIG. 3;

FIG. 8 illustrates an example anchor member of the example replacement heart valve implant of FIG. 2;

FIG. 8A is a partial side view of selected aspects of the example anchor member of FIG. 8; and

FIG. 9 is a side view of the example replacement heart valve implant of FIG. 2 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 spirit and scope of the disclosure.

Detailed Description

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.

For the following defined terms, these definitions shall be applied, unless a different definition is given in the claims or elsewhere in this specification.

All numeric values are herein assumed to be modified by the term "about," whether or not explicitly indicated. The term "about", in the context of numeric values, generally refers to a range of numbers that one of skill in the art would consider equivalent to the recited value (e.g., having the same function or result). In many instances, the term "about" may include numbers that are rounded to the nearest significant figure. Other uses of the term "about" (e.g., in a context other than numeric values) may be assumed to have their ordinary and customary definition(s), as understood from and consistent with the context of the specification, unless otherwise specified.

The recitation of numerical ranges by endpoints includes all numbers within that range, including the endpoints (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

Although some suitable dimensions, ranges, and/or values pertaining to various components, features and/or specifications are disclosed, one of skill in the art, incited by the present disclosure, would understand desired dimensions, ranges, and/or values may deviate from those expressly disclosed.

As used in this specification and the appended claims, the singular forms "a",

"an", and "the" include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise. It is to be noted that in order to facilitate understanding, certain features of the disclosure may be described in the singular, even though those features may be plural or recurring within the disclosed embodiment(s). Each instance of the features may include and/or be encompassed by the singular disclosure(s), unless expressly stated to the contrary. For simplicity and clarity purposes, not all elements of the disclosed invention are necessarily shown in each figure or discussed in detail below. However, it will be understood that the following discussion may apply equally to any and/or all of the components for which there are more than one, unless explicitly stated to the contrary. Additionally, not all instances of some elements or features may be shown in each figure for clarity.

Relative terms such as "proximal", "distal", "advance", "retract", variants thereof, and the like, may be generally considered with respect to the positioning, direction, and/or operation of various elements relative to a user/operator/manipulator of the device, wherein "proximal" and "retract" indicate or refer to closer to or toward the user and "distal" and "advance" indicate or refer to farther from or away from the user. In some instances, the terms "proximal" and "distal" may be arbitrarily assigned in an effort to facilitate understanding of the disclosure, and such instances will be readily apparent to the skilled artisan. Other relative terms, such as "upstream", "downstream", "inflow", and "outflow" refer to a direction of fluid flow within a lumen, such as a body lumen, a blood vessel, or within a device.

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.

It is noted that references in the specification to "an embodiment", "some embodiments", "other embodiments", etc., indicate that the embodiment(s) described may include a particular feature, structure, or characteristic, but every embodiment may not necessarily include the particular feature, structure, or characteristic. Moreover, such phrases are not necessarily referring to the same embodiment. Further, when a particular feature, structure, or characteristic is described in connection with an embodiment, it would be within the knowledge of one skilled in the art to effect the particular feature, structure, or characteristic in connection with other embodiments, whether or not explicitly described, unless clearly stated to the contrary. That is, the various individual elements described below, even if not explicitly shown in a particular combination, are nevertheless contemplated as being combinable or arrangeable with each other to form other additional embodiments or to complement and/or enrich the described embodiment(s), as would be understood by one of ordinary skill in the art.

For the purpose of clarity, certain identifying numerical nomenclature (e.g., first, second, third, fourth, etc.) may be used throughout the description and/or claims to name and/or differentiate between various described and/or claimed features. It is to be understood that the numerical nomenclature is not intended to be limiting and is exemplary only. In some embodiments, alterations of and deviations from previously - used numerical nomenclature may be made in the interest of brevity and clarity. That is, a feature identified as a "first" element may later be referred to as a "second" element, a "third" element, etc. or may be omitted entirely, and/or a different feature may be referred to as the "first" element. The meaning and/or designation in each instance will be apparent to the skilled practitioner.

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. 1 illustrates an example replacement heart valve delivery device 10 including a replacement heart valve implant 16 configured to be disposed within a native heart valve (e.g., a mitral valve, an aortic valve, etc.), wherein the replacement heart valve implant 16 may be disposed within a lumen of the replacement heart valve delivery device 10 in a delivery configuration for delivery to the native heart valve, where the replacement heart valve implant 16 may be shifted to a deployed configuration. In some embodiments, the replacement heart valve delivery device 10 may include a delivery sheath 12 having a lumen extending from a proximal portion and/or proximal end of the delivery sheath 12 to a distal end of the delivery sheath 12. The replacement heart valve implant 16 may be disposed within the lumen of the delivery sheath 12 proximate the distal end of the delivery sheath 12 in the delivery configuration. In some embodiments, the replacement heart valve delivery device 10 may include a handle 18 disposed proximate the proximal end of the delivery sheath 12.

The replacement heart valve delivery device 10 may include an elongate shaft 14 disposed within the lumen of the delivery sheath 12 and/or slidable with respect to the delivery sheath 12 within the lumen of the delivery sheath 12. In some embodiments, the elongate shaft 14 may be a tubular structure having a lumen extending therethrough, the elongate shaft 14 may be a solid shaft, or the elongate shaft 14 may be a combination thereof. In some embodiments, the replacement heart valve delivery device 10 may include a plurality of elongate members 15 releasably connecting the replacement heart valve implant 16 to the elongate shaft 14 and/or the handle 18. The plurality of elongate members 15 may extend distally from the elongate shaft 14 to the replacement heart valve implant 16. In some embodiments, the plurality of elongate members 15 may be slidably disposed within and/or may extend slidably through the elongate shaft 14.

In use, the elongate shaft 14 and/or the plurality of elongate members 15 may be used to move the replacement heart valve implant 16 with respect to the delivery sheath 12 of the replacement heart valve delivery device 10. For example, the elongate shaft 14 and/or the plurality of elongate members 15 may be advanced distally within the lumen of the delivery sheath 12 to push the replacement heart valve implant 16 out the distal end of the delivery sheath 12 and/or the replacement heart valve delivery device 10 to deploy the replacement heart valve implant 16 within the native heart valve. Alternatively, the elongate shaft 14 and/or the plurality of elongate members 15 may be held in a fixed position relative to the replacement heart valve implant 16 and the delivery sheath 12 may be withdrawn proximally relative to the elongate shaft 14, the plurality of elongate members 15, and/or the replacement heart valve implant 16 to deploy the replacement heart valve implant 16 within the native heart valve. Some examples of suitable but non-limiting materials for the replacement heart valve delivery device 10, the delivery sheath 12, the elongate shaft 14, the plurality of elongate members 15, the handle 18, and/or components or elements thereof, are described below.

FIGS. 2-7 illustrate an example replacement heart valve implant 16 in the delivery configuration (e.g., FIGS. 2, 6) and the deployed configuration (e.g., FIGS. 3-5, 7). The replacement heart valve implant 16 may define a central longitudinal axis 20 extending through a lumen of the replacement heart valve implant 16 from an upstream end 22 to a downstream end 24. The replacement heart valve implant 16 may include an expandable anchor member 30 configured to shift between the delivery configuration and the deployed configuration. In the delivery configuration, the expandable anchor member 30 may be radially compressed and/or longitudinally elongated, while in the deployed configuration, the expandable anchor member 30 may be radially expanded and/or longitudinally shortened.

In some embodiments, the expandable anchor member 30 may comprise an expandable stent structure and/or framework. In some embodiments, the expandable anchor member 30 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 30 and/or the replacement heart valve implant 16. 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 30 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 16, the expandable anchor member 30, and/or components or elements thereof, are described below.

FIG. 8 illustrates some additional aspects of the expandable anchor member 30, shown in the deployed configuration. In some embodiments, the expandable anchor member 30 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 30 may form a plurality of crowns 40 extending varying distances downstream from the upstream end 22. Each of the plurality of crowns 40 may define a downstreammost extent 42 of that crown. The downstreammost extents 42 of the plurality of crowns 40 may extend varying distances downstream from the upstream end 22. In some embodiments, the plurality of crowns 40 may comprise a plurality of commissure crowns 44, a plurality of intermediate crowns 46, and a plurality of anchor crowns 48.

The example replacement heart valve implant 16 and/or the expandable anchor member 30 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 44 may include two commissure crowns 44, three commissure crowns 44, or another suitable number of commissure crowns 44. Each of the plurality of intermediate crowns 46 may be disposed immediately adjacent the plurality of commissure crowns 44, such that one commissure crown 44 is disposed between two intermediate crowns 46. Accordingly, a pair of (e.g., two) intermediate crowns 46 may be disposed between two adjacent commissure crowns 44. In some embodiments, the plurality of intermediate crowns 46 may include four (e.g., two pair of) intermediate crowns 46, six (e.g., three pair of) intermediate crowns 46, or another suitable number of intermediate crowns correlated to and/or determined by the plurality of commissure crowns 44. The plurality of anchor crowns 48 may be disposed between each pair of intermediate crowns 46 disposed between two adjacent commissure crowns 44. In some embodiments, the plurality of anchor crowns 48 may include more than one discrete group of anchor crowns 48, wherein each discrete group of anchor crowns 48 is disposed between the pair of intermediate crowns 46 disposed between two adjacent commissure crowns 44. For example, as will become apparent, in a tricuspid or three-leaflet configuration, the plurality of anchor crowns 48 may include three discrete groups of anchor crowns 48.

As seen in FIG. 8A, the plurality of commissure crowns 44 may extend a first distance Dl downstream from the upstream end 22 in the delivery configuration and/or the deployed configuration. The plurality of intermediate crowns 46 may extend a second distance D2 downstream from the upstream end 22 in the delivery configuration and/or the deployed configuration. The plurality of anchor crowns 48 may extend a third distance D3 downstream from the upstream end 22 in the delivery configuration and/or the deployed configuration. In most embodiments, the first distance Dl is greater than the second distance D2 and the second distance D2 is greater than the third distance D3. Similarly, the first distance Dl 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 48 may extend a varying distance downstream from the upstream end 22 in the delivery configuration and/or the deployed configuration (e.g., the third distance D3 may vary within the plurality of anchor crowns 48 and/or within a discrete group of anchor crowns 48).

Turning back to FIGS. 2-7, the replacement heart valve implant 16 may include a circumferential support member 50 secured and/or attached to the expandable anchor member 30. In at least some embodiments, the circumferential support member 50 may be distinct and/or separately-formed from the expandable anchor member 30. In some embodiments, the circumferential support member 50 may be secured and/or attached to the expandable anchor member 30 using sutures, adhesive bonding, welding, brazing, or other suitable means. In one alternative example, the circumferential support member 50 may be unitary and/or integrally- formed with the expandable anchor member 30.

In some embodiments, at least a portion of the circumferential support member 50 may extend downstream of the expandable anchor member 30 (e.g., downstream of the downstreammost extent of the plurality of commissure crowns 44, and/or may extend a distance downstream from the upstream end 22 in the delivery configuration and/or the deployed configuration greater than the first distance Dl), as most easily seen in FIGS. 6 and 7 for example. In some embodiments, the circumferential support member 50 may be directly attached to at least two of the plurality of crowns 40 (e.g., at least two of the plurality of commissure crowns 44, etc.). In some embodiments, the circumferential support member 50 may be attached to the expandable anchor member 30 at about the third distance D3 downstream from the upstream end 22 in the delivery configuration and/or the deployed configuration. In some embodiments, the circumferential support member 50 may be attached to the expandable anchor member 30 at about the first distance Dl downstream from the upstream end 22 in the delivery configuration and/or the deployed configuration. In some embodiments, the at least two of the plurality of crowns 40 (e.g., at least two of the plurality of commissure crowns 44, etc.) to which the circumferential support member 50 is directly attached extend further downstream from the upstream end 22 in the delivery configuration and/or the deployed configuration than any immediately adjacent crowns 40 (e.g., the plurality of intermediate crowns 46, etc.) - for example, at a distance greater than the second distance D2.

In some embodiments, one of the plurality of crowns 40 longitudinally and/or circumferentially overlaps at least a portion of the circumferential support member 50 to define a commissure attachment location 52 in the delivery configuration and/or the deployed configuration. In some embodiments, the circumferential support member 50 may be directly attached to the expandable anchor member 30 at the commissure attachment location 52 in the delivery configuration and/or the deployed configuration. In some embodiments, more than one of the plurality of crowns 40 longitudinally and/or circumferentially overlaps at least a portion of the circumferential support member 50 to define more than one commissure attachment location 52 in the delivery configuration and/or the deployed configuration. In some embodiments, the circumferential support member 50 may be directly attached to the expandable anchor member 30 at each of the commissure attachment locations 52 in the delivery configuration and/or the deployed configuration.

In some embodiments, at least a portion of the circumferential support member 50 extends radially outward of and/or from the expandable anchor member 30 in the deployed configuration, as most easily seen in FIG. 5. Also shown in FIG. 5, but omitted from the other figures in the interest of clarity, the replacement heart valve implant 16 may include a plurality of valve leaflets 60 disposed within the lumen of the replacement heart valve implant 16 and/or secured to the expandable anchor member 30. In some embodiments, the plurality of valve leaflets 60 may be attached and/or secured to the expandable anchor member 30 at a plurality of locations within the lumen of the replacement heart valve implant 16 and/or the expandable anchor member 30. In some embodiments, the plurality of valve leaflets 60 may be attached and/or secured to the expandable anchor member 30 using sutures, adhesives, or other suitable means.

In some embodiments, the plurality of valve leaflets 60 may include two leaflets, three leaflets, four leaflets, etc. as desired. The plurality of valve leaflets 60 of the replacement heart valve implant 16 may be configured to move between an open configuration permitting antegrade fluid flow through the replacement heart valve implant 16 and/or the lumen of the replacement heart valve implant 16 and/or the expandable anchor member 30, and a closed configuration preventing retrograde fluid flow through the replacement heart valve implant 16 and/or the lumen of the replacement heart valve implant 16 and/or the expandable anchor member 30. The plurality of valve leaflets 60 may each have a free edge, wherein the free edges of the plurality of valve leaflets 60 coapt within the replacement heart valve implant 16, the expandable anchor member 30, and/or the lumen extending through the expandable anchor member 30 in the closed configuration. Some examples of suitable but non- limiting materials for the plurality of valve leaflets 60 may include bovine pericardial, polymeric materials, or other suitably flexible biocompatible materials.

The plurality of valve leaflets 60 may include a valve leaflet commissure 62 movable from a first longitudinal position within the lumen of the replacement heart valve implant 16 and/or the expandable anchor member 30 relative to the downstream end 24 in the delivery configuration, as seen in FIG. 6, to a second longitudinal position within the lumen of the replacement heart valve implant 16 and/or the expandable anchor member 30 relative to the downstream end 24 in the deployed configuration, as seen in FIG. 7. Further description regarding this movement is provided below. In some embodiments, the plurality of valve leaflets 60 may include more than one valve leaflet commissure 62. For example, each adjacent pair of valve leaflets 60 may form and/or define one valve leaflet commissure 62. Therefore, the number of valve leaflet commissures 62 may be directly related to the number of valve leaflets 60 (e.g., three valve leaflets 60 form and/or define three valve leaflet commissures 62, two valve leaflets 60 form and/or define two valve leaflet commissures 62, etc.), as seen in FIG. 5.

Turning back to FIGS. 2-5, in some embodiments, the circumferential support member 50 may include a plurality of lobes 54 extending circumferentially around the central longitudinal axis 20, each lobe 54 corresponding to one of the plurality of valve leaflets 60 and/or positioned opposite one of the plurality of valve leaflets 60 with respect to the expandable anchor member 30. The plurality of lobes 54 may each extend radially outward from the expandable anchor member 30. In some embodiments, the plurality of lobes 54 may each be positioned against and/or proximate the outer surface of the expandable anchor member 30 in the delivery configuration, as seen in FIG. 2 for example. The plurality of lobes 54 may each extend radially outward from, and may be radially spaced away from, the outer surface of the expandable anchor member 30 in the deployed configuration, as seen in FIGS. 3-5 for example. The circumferential support member 50 may include a longitudinal portion 56 extending toward the upstream end 22, the longitudinal portion 56 being disposed between circumferentially adjacent lobes 54 of the plurality of lobes 54. In some embodiments, the circumferential support member 50 may include a plurality of longitudinal portions 56 corresponding to the plurality of lobes 54, each longitudinal portion 56 being disposed between two circumferentially adjacent lobes 54 of the plurality of lobes 54. In some embodiments, the and/or each longitudinal portion 56 may correspond to and/or at least partially define the commissure attachment location(s) 52. Each lobe 54 adjacent the commissure attachment location(s) 52 may extend toward the upstream end 22 and/or radially outward from the commissure attachment location(s) 52.

In the deployed configuration, at least a portion of the circumferential support member 50 extends radially outward from the expandable anchor member 30, upstream and/or toward the upstream end 22 from the plurality of commissure crowns 44, and reaches its upstreammost extent (e.g., the position or extent longitudinally closest to the upstream end 22 and/or farthest from the downstream end 24) proximate the plurality of anchor crowns 48. For example, as seen in the deployed configuration illustrated in FIG. 4, the upstreammost extent of at least a portion of the circumferential support member 50 is proximate the plurality of anchor crowns 48. In some embodiments, the upstreammost extent of the circumferential support member 50 may be defined by the longitudinal portion(s) 56. In some embodiments, the upstreammost extent of the circumferential support member 50 may be defined by one or more of the plurality of lobes 54.

Additionally, in the deployed configuration, the circumferential support member 50 may approximate a path around the replacement heart valve implant 16 and/or the central longitudinal axis 20 following the longitudinal position of the downstreammost extents of the plurality of crowns 40 (e.g., the plurality of commissure crowns 44, the plurality of intermediate crowns 46, and/or the plurality of anchor crowns 48) along a common radius from the central longitudinal axis 20. For example, when viewed radially outwardly from the central longitudinal axis 20, as the view is rotated on the central longitudinal axis 20 (e.g., when turning as to produce a 360-degree view) the path of the circumferential support member 50 may generally follow, mimic, and/or approximate a path connecting, following, and/or along the downstreammost extents of the plurality of crowns 40 (e.g., the plurality of commissure crowns 44, the plurality of intermediate crowns 46, and/or the plurality of anchor crowns 48). Some examples of suitable but non-limiting materials for the circumferential support member 50, the plurality of lobes 54, the longitudinal portion(s) 56, and/or components or elements thereof, are described below.

In some embodiments, the replacement heart valve implant 16 may include a seal member 70 disposed on and/or around at least a portion of the outer surface of the expandable anchor member 30. In some embodiments, the seal member 70 may be coupled and/or secured to the expandable anchor member 30 and/or the plurality of valve leaflets 60. In some embodiments, a downstream edge 72 of the seal member 70 may follow the downstreammost extents of the plurality of crowns 40 (e.g., the plurality of commissure crowns 44, the plurality of intermediate crowns 46, and/or the plurality of anchor crowns 48). The seal member 70 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 16 and/or the expandable anchor member 30 within and/or against the native heart valve and/or the native valve leaflets and preventing leakage around the replacement heart valve implant 16 and/or the expandable anchor member 30.

In some embodiments, the seal member 70 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, polyvinylchloride, 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 16 and/or the expandable anchor member 30 is shifted from the delivery configuration to the deployed configuration, the valve leaflet commissure(s) 62 moves from the first longitudinal position relative to the downstream end 24 in the delivery configuration (e.g., FIG. 6) to the second longitudinal position relative to the downstream end 24 in the deployed configuration (e.g., FIG. 7). As seen in FIGS. 6 and 7, the valve leaflet commissure(s) 62 may be releasably connected to the plurality of elongate members 15 (of the replacement heart valve delivery device 10). In some embodiments, as the replacement heart valve implant 16 is deployed, the valve leaflet commissure(s) 62 may be pulled toward the commissure attachment location(s) 52, which may be held in a fixed position, or the commissure attachment location(s) 52 may be pushed toward the valve leaflet commissure(s) 62, which may be held in a fixed position. In some embodiments, the valve leaflet commissure(s) 62 may be pulled toward the commissure attachment location(s) 52 and the commissure attachment location(s) 52 may be pushed toward the valve leaflet commissure(s) 62, either in sequence or simultaneously. The valve leaflet commissure(s) 62 may be attached to the expandable anchor member 30 at the commissure attachment location(s) 52 in the deployed configuration. The valve leaflet commissure(s) 62 may also be attached to the expandable anchor member 30 at the upstream end 22 in the delivery configuration and in the deployed configuration, using a suture for example.

Turning now to FIG. 9, in some embodiments, the replacement heart valve implant 16 may further comprise a fabric element 80 overlapping the commissure attachment location(s) 52 (only one instance of which is shown/discussed in the interest of brevity and/or clarity). In some embodiments, the fabric element 80 may be disposed over the outer surface of the expandable anchor member 30, an inner surface of the expandable anchor member 30, an outer surface of the circumferential support member 50, an inner surface of the circumferential support member 50, and/or combinations thereof.

In some embodiments, the fabric element 80 may be wrapped around one of the plurality of crowns 40 (e.g., the commissure crowns 44, the intermediate crowns 46, the anchor crowns 48) and the portion of the circumferential support member 50 overlapped by that crown. For example, in some embodiments, the commissure crown(s) 44 may longitudinally and/or circumferentially overlap at least a portion of the circumferential support member 50 (e.g., the longitudinal portion(s) 56), and the fabric element 80 may be wrapped around the and/or each commissure crown 44 and the corresponding longitudinal portion 56 of the circumferential support member 50.

In some embodiments, the fabric element 80 may extend from the commissure attachment location(s) 52 upstream and/or toward the upstream end 22 to each immediately adjacent crown 40. For example, in some embodiments, the fabric element 80 may extend from the commissure attachment location(s) 52 (and/or the commissure crown 44 corresponding thereto) upstream and/or toward the upstream end 22 to each immediately adjacent intermediate crown 46. A shape of the fabric element 80 may generally correspond to and/or align with the circumferential support member 50, as seen in FIG. 9 for example. The fabric element 80 may provide additional sealing around the replacement heart valve implant 16 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 16 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 80, 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 10, the replacement heart valve implant 16, the expandable anchor member 30, the circumferential support member 50, the seal member 70, the fabric element 80, 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 10, the replacement heart valve implant 16, the expandable anchor member 30, the circumferential support member 50, the seal member 70, the fabric element 80, 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 12, the elongate shaft 14, the plurality of elongate members 15, the handle 18, the plurality of crowns 40, the plurality of lobes 54, the longitudinal portion(s) 56, and/or elements or components thereof. In some embodiments, the replacement heart valve delivery device 10, the replacement heart valve implant 16, the expandable anchor member 30, the circumferential support member 50, the seal member 70, the fabric element 80, 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, 444L, 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® 625, UNS: N06022 such as HASTELLOY® C-22®, UNS: N10276 such as HASTELLOY® C276®, other HASTELLOY® alloys, and the like), nickel-copper alloys (e.g., UNS: N04400 such as MONEL® 400, NICKELVAC® 400, NICORROS® 400, 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.

As alluded to herein, within the family of commercially available nickel- titanium or nitinol alloys, is a category designated "linear elastic" or "non-super- elastic" which, although may be similar in chemistry to conventional shape memory and super elastic varieties, may exhibit distinct and useful mechanical properties. Linear elastic and/or non-super-elastic nitinol may be distinguished from super elastic nitinol in that the linear elastic and/or non-super-elastic nitinol does not display a substantial "superelastic plateau" or "flag region" in its stress/strain curve like super elastic nitinol does. Instead, in the linear elastic and/or non-super-elastic nitinol, as recoverable strain increases, the stress continues to increase in a substantially linear, or a somewhat, but not necessarily entirely linear relationship until plastic deformation begins or at least in a relationship that is more linear than the super elastic plateau and/or flag region that may be seen with super elastic nitinol. Thus, for the purposes of this disclosure linear elastic and/or non-super-elastic nitinol may also be termed "substantially" linear elastic and/or non-super-elastic nitinol.

In some cases, linear elastic and/or non-super-elastic nitinol may also be distinguishable from super elastic nitinol in that linear elastic and/or non-super-elastic nitinol may accept up to about 2-5% strain while remaining substantially elastic (e.g., before plastically deforming) whereas super elastic nitinol may accept up to about 8% strain before plastically deforming. Both of these materials can be distinguished from other linear elastic materials such as stainless steel (that can also be distinguished based on its composition), which may accept only about 0.2 to 0.44 percent strain before plastically deforming.

In some embodiments, the linear elastic and/or non-super-elastic nickel- titanium alloy is an alloy that does not show any martensite/austenite phase changes that are detectable by differential scanning calorimetry (DSC) and dynamic metal thermal analysis (DMTA) analysis over a large temperature range. For example, in some embodiments, there may be no martensite/austenite phase changes detectable by DSC and DMTA analysis in the range of about -60 degrees Celsius (°C) to about 120 °C in the linear elastic and/or non-super-elastic nickel -titanium alloy. The mechanical bending properties of such material may therefore be generally inert to the effect of temperature over this very broad range of temperature. In some embodiments, the mechanical bending properties of the linear elastic and/or non-super-elastic nickel- titanium alloy at ambient or room temperature are substantially the same as the mechanical properties at body temperature, for example, in that they do not display a super-elastic plateau and/or flag region. In other words, across a broad temperature range, the linear elastic and/or non-super-elastic nickel -titanium alloy maintains its linear elastic and/or non-super-elastic characteristics and/or properties.

In some embodiments, the linear elastic and/or non-super-elastic nickel- titanium alloy may be in the range of about 50 to about 60 weight percent nickel, with the remainder being essentially titanium. In some embodiments, the composition is in the range of about 54 to about 57 weight percent nickel. One example of a suitable nickel-titanium alloy is FHP-NT alloy commercially available from Furukawa Techno Material Co. of Kanagawa, Japan. Other suitable materials may include ULTANIUM™ (available from Neo-Metrics) and GUM METAL™ (available from Toyota). In some other embodiments, a superelastic alloy, for example a superelastic nitinol can be used to achieve desired properties. In at least some embodiments, portions or all of the replacement heart valve delivery device 10, the replacement heart valve implant 16, the expandable anchor member 30, the circumferential support member 50, the seal member 70, the fabric element 80, 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 10, the replacement heart valve implant 16, the expandable anchor member 30, the circumferential support member 50, the seal member 70, the fabric element 80, 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 10, the replacement heart valve implant 16, the expandable anchor member 30, the circumferential support member 50, the seal member 70, the fabric element 80, 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 10, the replacement heart valve implant 16, the expandable anchor member 30, the circumferential support member 50, the seal member 70, the fabric element 80, etc. For example, the replacement heart valve delivery device 10, the replacement heart valve implant 16, the expandable anchor member 30, the circumferential support member 50, the seal member 70, the fabric element 80, 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 10, the replacement heart valve implant 16, the expandable anchor member 30, the circumferential support member 50, the seal member 70, the fabric element 80, 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., U S: 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 10, the replacement heart valve implant 16, the expandable anchor member 30, the circumferential support member 50, the seal member 70, the fabric element 80, 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 85 A), 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-12 (such as GRILAMID® available from EMS American Grilon), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefin, polystyrene, epoxy, polyvinylidene chloride (PVdC), poly(styrene-/ Sobutylene-Z>- 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 6 percent LCP. In some embodiments, the replacement heart valve delivery device 10, the replacement heart valve implant 16, the expandable anchor member 30, the circumferential support member 50, the seal member 70, the fabric element 80, etc. may include a textile material. Some examples of suitable textile materials may include synthetic yams that may be flat, shaped, twisted, textured, pre-shrunk or un- shrunk. Synthetic biocompatible yams 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 yams may be a metallic yam or a glass or ceramic yam or fiber. Useful metallic yams include those yams made from or containing stainless steel, platinum, gold, titanium, tantalum or a Ni-Co-Cr-based alloy. The yams may further include carbon, glass or ceramic fibers. Desirably, the yams are made from thermoplastic materials including, but not limited to, polyesters, polypropylenes, polyethylenes, polyurethanes, polynaphthalenes, polytetrafluoroethylenes, and the like. The yams may be of the multifilament, monofilament, or spun-types. The type and denier of the yam 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 10, the replacement heart valve implant 16, the expandable anchor member 30, the circumferential support member 50, the seal member 70, the fabric element 80, 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, 5-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.

It should be understood that this disclosure is, in many respects, only illustrative. Changes may be made in details, particularly in matters of shape, size, and arrangement of steps without exceeding the scope of the invention. This may include, to the extent that it is appropriate, the use of any of the features of one example embodiment being used in other embodiments. The invention's scope is, of course, defined in the language in which the appended claims are expressed.