Apparatus for compressing a replacement heart valve implant - Patent Application 20070122997

Abstract

The apparatus for compressing a replacement heart valve implant may include a tubular member having a wall with an outer surface and an inner surface forming a lumen of the tubular member, the inner surface including a tapered portion having a radially inward taper in a distal direction and a plurality of flexible arms projecting radially inward from the tapered portion. The plurality of flexible arms may project radially inward from the inner surface in an unbiased configuration at least 50% of the distance from the inner surface to a central longitudinal axis of the tubular member. The plurality of flexible arms may be configured to urge a plurality of leaflets of the replacement heart valve implant radially inward as the replacement heart valve implant passes through the tubular member.

Description

[Technical Field]

[0001] The present disclosure relates to medical devices, systems, and methods for making and / or using the medical devices and / or systems. More particularly, the present disclosure relates to an improved design for an apparatus for compressing replacement heart valve implants, and methods for using the apparatus. [Background technology]

[0002] A wide variety of intracorporeal medical devices have been developed for medical applications, such as intravascular use. Some of these devices include guidewires, catheters, medical device delivery systems (e.g., stents, grafts, replacement valves, etc.), and the like. These devices can be manufactured by any one of a variety of different manufacturing methods and used according to any one of a variety of different methods. Each of the known medical devices and methods has certain advantages and disadvantages. There is a continuing need to provide alternative medical devices and alternative methods of manufacturing and using medical devices. Summary of the Invention

[0003] In one embodiment, a device for compressing a replacement heart valve implant may include a tubular member having a wall, the wall having an outer surface and an inner surface forming a lumen of the tubular member, the inner surface including a tapered portion tapering radially inward in a distal direction, and a plurality of flexible arms projecting radially inward from the tapered portion, the plurality of flexible arms projecting radially inward from the inner surface in an unbiased configuration at least 50% of the distance from the inner surface to a central longitudinal axis of the tubular member.

[0004] Additionally or alternatively to any example described herein, the plurality of flexible arms, in the unbiased configuration, protrude radially inward from the inner surface at least 75% of the distance from the inner surface to the central longitudinal axis of the tubular member.

[0005] Additionally or alternatively to any of the examples described herein, the plurality of flexible arms are fixedly attached to the wall of the tubular member. Additionally or alternatively to any of the examples described herein, the plurality of flexible arms are formed from a monofilament polymer material.

[0006] Additionally or alternatively to any of the examples described herein, the plurality of flexible arms are formed from a different material than the tubular member. Additionally or alternatively to any of the examples described herein, the device may further include a threaded nut configured to engage threads formed on the outer surface of the tubular member, and a push member comprising an annular ring and a plurality of extension members extending radially inward from the annular ring, the annular ring configured to slide over the outer surface of the tubular member.

[0007] Additionally or alternatively to any example described herein, the tubular member includes a plurality of longitudinal slots extending through the wall, and the plurality of extension members extend through the plurality of longitudinal slots and into the lumen of the tubular member when the annular ring slides over the outer surface of the tubular member.

[0008] Additionally or alternatively to any of the examples described herein, a replacement heart valve system may include a replacement heart valve implant including an expandable framework and a plurality of leaflets secured to the expandable framework, and an apparatus for compressing the replacement heart valve implant. The apparatus may include a tubular member having a wall, the wall having an outer surface and an inner surface forming a lumen of the tubular member, the inner surface including a tapered portion tapering radially inward in a distal direction and a plurality of flexible arms projecting radially inward from the tapered portion. The flexible arms are configured to compress the plurality of leaflets radially inward as the replacement heart valve implant passes through the tubular member.

[0009] Additionally or alternatively to any of the examples described herein, the multiple flexible arms are equally circumferentially spaced about the central longitudinal axis of the tubular member. Additionally or alternatively to any of the examples described herein, the flexible arms are spaced approximately 120 degrees apart from one another.

[0010] Additionally or alternatively to any of the examples described herein, each of the plurality of leaflets is engaged by only one of the plurality of flexible arms as the replacement heart valve implant passes through the tubular member.

[0011] Additionally or alternatively to any of the examples described herein, the leaflets are secured to the expandable framework at the commissures and include free edges extending between the commissures, and between circumferentially adjacent commissures, the replacement heart valve implant is free of the expandable framework at longitudinal locations radially outward of the free edges of the leaflets.

[0012] Additionally or alternatively to any of the examples described herein, a method of compressing a replacement heart valve implant may include: Inserting the inflow end of the replacement heart valve implant into a device for compressing the replacement heart valve implant, the device comprising: a tubular member having a wall, the wall having an outer surface and an inner surface forming a lumen of the tubular member, the inner surface including a tapered portion tapering radially inward in a distal direction; a plurality of flexible arms projecting radially inward from the tapered portion; sliding a push member including an annular ring and a plurality of extension members extending radially inward from the annular ring over the proximal end of the tubular member until the plurality of extension members engage the plurality of commissures of the replacement heart valve implant; disposing a threaded nut on the proximal end of the tubular member, the threaded nut configured to engage threads formed on an exterior surface of the tubular member; and advancing the threaded nut distally along the tubular member to move the push member distally along the tubular member, the push member advancing the replacement heart valve implant distally within the lumen of the tubular member.

[0013] Additionally or alternatively to any of the examples described herein, as the replacement heart valve implant is advanced through the plurality of flexible arms, the plurality of flexible arms push the plurality of leaflets of the replacement heart valve implant radially inward from the expandable framework of the replacement heart valve implant.

[0014] Additionally or alternatively to any example described herein, each of the plurality of flexible arms is circumferentially disposed between two circumferentially adjacent extension members of the plurality of extension members.

[0015] Additionally or alternatively to any of the examples described herein, a plurality of extension members extend radially inward through a plurality of longitudinal slots formed in the tubular member. Additionally or alternatively to any of the examples described herein, the plurality of longitudinal slots extend from the proximal end of the tubular member toward the distal end of the tubular member.

[0016] Additionally or alternatively to any example described herein, each of the plurality of flexible arms is circumferentially disposed between two circumferentially adjacent longitudinal slots of the plurality of longitudinal slots.

[0017] In addition to or in the alternative to any of the examples described herein, the replacement heart valve implant is radially compressed by advancing the replacement heart valve implant distally within the lumen of the tubular member.

[0018] Additionally or alternatively to any of the examples described herein, a plurality of flexible arms extend distally from the inner surface of the tubular member within the lumen of the tubular member. The above summary of some embodiments, aspects, and / or examples is not intended to describe each disclosed embodiment or every implementation of the present disclosure. The following figures and detailed description more particularly exemplify these embodiments. [Brief explanation of the drawings]

[0019] The present disclosure may be more fully understood by considering the following detailed description in conjunction with the accompanying drawings, in which: [Figure 1] 1A-1D illustrate selected aspects of a replacement heart valve implant. [Figure 2] 2A-2C illustrate selected embodiments of an apparatus for compressing the replacement heart valve implant of FIG. 1. [Figure 3] 3A-3C are cross-sectional views showing selected aspects of the device of FIG. 2. [Figure 4] 3 is an end view of selected aspects of the device of FIG. 2. [Figure 5] FIG. 3 is an exploded view showing selected aspects of the device of FIG. 2. [Figure 6] FIG. 1 is an exploded view illustrating selected aspects of a replacement heart valve system. [Figure 7] 1A-1D illustrate aspects of a method for compressing a replacement heart valve implant. [Figure 8] 1A-1D illustrate aspects of a method for compressing a replacement heart valve implant. [Figure 9] 1A-1D illustrate aspects of a method for compressing a replacement heart valve implant. [Figure 10] 1A-1D illustrate aspects of a method for compressing a replacement heart valve implant. DETAILED DESCRIPTION OF THE INVENTION

[0020] While aspects of the present disclosure are amenable to various modifications and alternative forms, details 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 present disclosure to the particular embodiments described. On the contrary, the present invention covers all modifications, equivalents, and alternatives falling within the spirit and scope of the present disclosure.

[0021] The following description should be read with reference to the drawings, which are not necessarily to scale, and in which like reference numerals indicate like elements throughout the several views. The detailed description and drawings are intended to illustrate, not limit, the disclosure. Those skilled in the art will recognize that the various elements described and / or illustrated can be arranged in various combinations and configurations without departing from the scope of the present disclosure. The detailed description and drawings illustrate exemplary embodiments of the present disclosure. However, for clarity and ease of understanding, not all features and / or elements may be shown in every drawing.

[0022] For the following defined terms, these definitions shall be applied, unless a different definition is given in the claims or elsewhere in this specification. In this specification, all numerical values ​​are assumed to be modified by the term "about," whether explicitly stated or not. The term "about" in the context of numerical values ​​generally refers to a range of numbers that one of ordinary skill in the art would consider equivalent to the recited value (e.g., having the same function or result). In many cases, the term "about" can include numbers that are rounded to the nearest significant figure. Other uses of the term "about" (e.g., in contexts other than numerical values) can be assumed to have their ordinary and customary definition as understood from and consistent with the context of this specification, unless otherwise specified.

[0023] The recitation of numerical ranges by endpoints includes all numbers within that range, inclusive of the endpoints (eg, 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5). Although some suitable dimensions, ranges and / or values ​​for various components, features and / or specifications are disclosed, those skilled in the art inspired by this disclosure will understand that the desired dimensions, ranges and / or values ​​may deviate from those expressly disclosed.

[0024] 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 used in its sense to include "and / or" unless the content clearly dictates otherwise. For ease of understanding, it should be noted that some features of the present disclosure may be described in the singular even though those features may be multiple or repeated within a disclosed embodiment. Each instance of a feature may include and / or be encompassed by the singular disclosure unless expressly stated to the contrary. For simplicity and clarity, not every element of the disclosure is necessarily shown in every figure or described in detail below. However, it will be understood that the following description may apply equally to any and / or all components present in more than one instance unless expressly stated to the contrary. Moreover, for clarity, not every instance of some elements or features is shown in every figure.

[0025] Relative terms such as “proximal,” “distal,” “advance,” “retract,” and variations thereof may generally be considered with respect to the position, orientation, and / or movement of various elements relative to a user / operator / manipulator of a device, with “proximal” and “retract” indicating or referring to being closer to or toward the user, and “distal” and “advance” indicating or referring to being farther from or away from the user. In some cases, the terms “proximal” and “distal” may be assigned arbitrarily to facilitate understanding of the present disclosure, and such instances will be readily apparent to those skilled in the art. Other relative terms, such as “upstream,” “downstream,” “inflow,” and “outflow,” refer to the direction of fluid flow within a body lumen, a lumen such as a blood vessel, or within a device. Still other relative terms, such as “axial,” “circumferential,” “longitudinal,” “lateral,” “radial,” and / or variations thereof, generally refer to directions and / or orientations relative to a central longitudinal axis of the disclosed structure or device.

[0026] The term "range" may be understood to mean the maximum measurement of a stated or specified dimension unless the range or dimension is followed by or specified as "minimum," which may be understood to mean the minimum measurement of the stated or specified dimension. For example, an "outer range" may be understood to mean an outer dimension, a "radial range" may be understood to mean a radial dimension, and a "longitudinal range" may be understood to mean a longitudinal dimension. Each instance of "range" may be different (e.g., axially, longitudinally, laterally, radially, circumferentially, etc.) and will be apparent to one of ordinary skill in the art from the context of the particular use. Generally, a "range" may be considered the maximum possible dimension measured according to the intended use, while a "minimum range" may be considered the minimum possible dimension measured according to the intended use. In some cases, a "range" may generally be measured orthogonally in a plane and / or cross-section, but may also be measured differently, such as, but not limited to, angularly, radially, circumferentially (e.g., along an arc), etc., as will become apparent from the particular context.

[0027] The terms "monolithic" and "unitary" shall generally refer to one or more elements made from or consisting of a single structure or base unit / element. Monolithic and / or unitary element shall exclude structures and / or features made by assembling or otherwise joining together multiple separate structures or elements.

[0028] The terms "transaortic valve implantation" and "transcatheter aortic valve implantation" are sometimes used interchangeably and may each be referred to using the acronym "TAVI (transcatheter aortic valve implantation)." The terms "transaortic valve replacement" and "transcatheter aortic valve replacement" are sometimes used interchangeably and may each be referred to using the acronym "TAVR (transcatheter aortic valve replacement)."

[0029] It should be noted that references herein to "one embodiment," "some embodiments," "other embodiments," etc., indicate that the described embodiment may include a particular feature, structure, or characteristic, but that not all embodiments necessarily include the particular feature, structure, or characteristic. Moreover, such phrases do not necessarily refer to the same embodiment. Furthermore, when a particular feature, structure, or characteristic is described in connection with an embodiment, it will be within the knowledge of one of ordinary skill in the art to affect the particular feature, structure, or characteristic in connection with other embodiments, unless expressly stated to the contrary, whether or not explicitly described. That is, it is contemplated that various individual elements described below, even if not explicitly shown in specific combinations, can be combined or arranged with one another to form other or additional embodiments, or to complement and / or enhance the described embodiments, as will be understood by one of ordinary skill in the art.

[0030] For purposes of clarity, certain distinguishing numerical nomenclature (e.g., first, second, third, fourth, etc.) may be used throughout the specification and / or claims to name and / or distinguish various features of the specification and / or claims. It should be understood that the numerical nomenclature is not intended to be limiting and is merely exemplary. In some embodiments, variations and departures from previously used numerical nomenclature may be made for brevity and clarity. That is, a feature identified as a "first" element may later be referred to as a "second," "third," etc., or may be omitted entirely, and / or a different feature may be referred to as the "first" element. The meaning and / or name in each instance will be apparent to one of ordinary skill in the art.

[0031] Diseases and / or conditions affecting the cardiovascular system are widespread throughout the world. Traditionally, treatment of the cardiovascular system has often been performed by directly accessing the affected portion of the system. For example, treatment of blockages in one or more coronary arteries has traditionally been treated using coronary artery bypass surgery. As can be readily appreciated, such treatments are highly invasive for the patient and require significant recovery time and / or procedures. More recently, less invasive treatments (e.g., angioplasty) have been developed that allow blocked coronary arteries to be accessed and treated, for example, via a percutaneous catheter. Such treatments have gained widespread acceptance among patients and clinicians.

[0032] The heart of some mammals (e.g., humans) contains four heart valves: the tricuspid valve, the pulmonary valve, the aortic valve, and the mitral valve. Several relatively common conditions may involve or result from inefficiency, ineffectiveness, or complete failure of one or more of the valves in the heart. For example, aortic or mitral valve failure can have serious consequences for the human body and, if not properly addressed, can lead to serious health conditions or death. Treating defective heart valves poses another challenge in that this treatment often requires repair or complete replacement of the defective heart valve. Such treatments can be highly invasive for the patient. Disclosed herein are devices, systems, and / or methods that can be used to prepare and / or deliver medical implants to portions of the cardiovascular system to diagnose, treat, and / or repair the cardiovascular system. In some embodiments, the devices, systems, and / or methods disclosed herein can be used before and / or during procedures to diagnose, treat, and / or repair defective heart valves (e.g., aortic valves, mitral valves, etc.). Additionally, the replacement heart valve implant may be delivered percutaneously and therefore much less invasive to the patient. The devices, systems, and / or methods disclosed herein may also provide other desirable features and / or advantages, as described below.

[0033] It should be noted that for ease of understanding, certain features of the present disclosure may be described in the singular even though those features may be plural or repeated within one or more disclosed embodiments. Each instance of a feature may include and / or be encompassed by the singular or plural disclosures unless expressly stated to the contrary. For example, a reference to a "leaflet," "lumen," or other feature may equally refer to all instances and quantities of more than one of said feature. Accordingly, it will be understood that the following description may equally apply to any and / or all of two or more components present in a replacement heart valve implant and / or device, unless expressly stated to the contrary.

[0034] Additionally, it should be noted that in any given figure, some features may not be shown or may be shown schematically for clarity and / or simplicity. Additional details regarding some components and / or method steps may be shown in greater detail in other figures. The devices and / or systems may be used to prepare and / or deliver various medical devices to several locations within the anatomy. In at least some embodiments, the devices and / or systems may be used to prepare and / or deliver a replacement aortic heart valve and, for brevity, will be described herein in that context. However, this is not intended to be limiting, as the devices and / or systems may also be used for other interventions, including mitral valve replacement, valve repair, etc., or other similar interventions.

[0035] 1 illustrates selected embodiments of a replacement heart valve implant 100. It should be understood that the replacement heart valve implant 100 can be any type of heart valve (e.g., mitral valve, aortic valve, etc.). In use, the replacement heart valve implant 100 can be implanted (e.g., surgically or via transcatheter delivery) into the heart of a mammal. The replacement heart valve implant 100 can be configured to allow unidirectional flow through the replacement heart valve implant 100 from the inflow end to the outflow end.

[0036] The replacement heart valve implant 100 may include an expandable framework 102 that, in some embodiments, forms a central lumen that may be substantially cylindrical. The side of the expandable framework 102 and other components that faces the central lumen may be referred to as the lumen surface or lumen side. The opposite side of the expandable framework 102 and other components (e.g., the side facing away from the central lumen) may be referred to as the abluminal surface or abluminal side. In some embodiments, the expandable framework 102 may have a substantially circular cross-section. In some embodiments, the expandable framework 102 may have a non-circular cross-section (e.g., D-shaped, elliptical, etc.). In some embodiments, a non-circular expandable framework may be used to repair a mitral valve or another non-circular valve in the body. Some suitable, but non-limiting, examples of materials that may be used to form the expandable framework 102 are described below, including, but not limited to, metals and metal alloys, composites, ceramics, polymers, etc.

[0037] The expandable framework 102 may include a plurality of frame struts. The frame struts may form a framework or lattice structure. In some embodiments, the expandable framework 102 may form open spaces or gaps between the frame struts. However, in other embodiments, the expandable framework 102 may not include such open spaces.

[0038] In some embodiments, the expandable framework 102 and / or frame struts may form a lower crown 106, an upper crown 108, and a plurality of stabilizing arches 110. In some embodiments, the lower crown 106 may be disposed at and / or correspond to the inflow end of the expandable framework 102 and / or replacement heart valve implant 100. In some embodiments, the upper crown 108 and / or the plurality of stabilizing arches 110 may be disposed at and / or correspond to the outflow end of the expandable framework 102 and / or replacement heart valve implant 100.

[0039] The replacement heart valve implant 100 may include multiple leaflets 104 disposed within the central lumen. Each of the multiple leaflets 104 may include a root edge coupled to the expandable framework 102 and a free edge (e.g., a coaptation edge) movable relative to the root edge to coapt with the coaptation edge of another leaflet along a coaptation region. In some embodiments, the multiple leaflets 104 may be integrally formed with one another such that the multiple leaflets 104 are formed as a single, integral and / or monolithic unit. In some embodiments, the "root edge" may be a formed edge, such as when the multiple leaflets 104 are formed in place on the expandable framework 102. In some embodiments, the plurality of leaflets 104 may be integrally formed with other structures, such as the inner skirt 112 and / or outer skirt 114, a base structure, a liner, etc., and in those situations, the "root edge" is not a cut or otherwise divided edge, but rather the location opposite the free edge where each of the plurality of leaflets 104 contacts those other structures.

[0040] The free edges of the leaflets 104 can move together in the closed position to substantially restrict fluid flow through the replacement heart valve implant 100. Specifically, the leaflets 104 can move together to fill or close the central lumen of the replacement heart valve implant 100, thereby preventing fluid flow in an upstream or retrograde direction. The free edges of the leaflets 104 can move apart in the open position to allow fluid flow through the replacement heart valve implant 100. Specifically, the leaflets 104 can move apart to open the central lumen of the replacement heart valve implant 100, thereby allowing fluid flow in a downstream or antegrade direction. In FIG. 1 , the leaflets 104 are shown in an open or partially open position (e.g., a neutral position) to which the leaflets 104 can move when unbiased by fluid flow.

[0041] Each of the plurality of leaflets 104 may further include two connecting portions. One connecting portion may be disposed on either end of the free edge of that individual leaflet such that the connecting portion contacts or abuts the expandable framework 102 at the plurality of commissures 116. In some embodiments, the plurality of leaflets 104 may be fixed and / or attached to the expandable framework 102 at the plurality of commissures 116. The free edges of the plurality of leaflets 104 may extend between the plurality of commissures 116.

[0042] In some embodiments, the commissures 116 may be disposed at the base of the stabilizing arches 110. In some embodiments, each of the commissures 116 may connect circumferentially adjacent stabilizing arches of the stabilizing arches 110 together. In some embodiments, the commissures 116 may be disposed distal to the stabilizing arches 110 and proximal to the upper crown 108. In at least some embodiments, between circumferentially adjacent commissures of the commissures 116, the replacement heart valve implant 100 is not provided with the expandable framework 102 at longitudinal positions radially outward from the free edges of the leaflets 104. Thus, the free edges of the leaflets 104 may not be in direct contact with the expandable framework 102 when the leaflets 104 open and / or close.

[0043] In some embodiments, the connecting portions of the plurality of leaflets 104 may be referred to as commissure attachment tabs. In some embodiments, the connecting portions are at least partially disposed within connecting openings formed and / or extending through the expandable framework 102, thereby allowing the plurality of leaflets 104 to be coupled or attached to the expandable framework 102. In some embodiments, the connecting portions may be protrusions from their respective leaflets. In some embodiments, the connecting portions may be integrally formed with their respective leaflets, such that the leaflets and connecting portions are a single, unitary and / or monolithic part or structure. In some embodiments, the connecting portions of the leaflets may extend completely through the connecting openings, such as when the connecting openings extend completely through the expandable framework 102.

[0044] In some embodiments, the connecting portions may surround a portion of the expandable framework 102, such as when the connecting portions contact the struts where the struts and / or the expandable framework 102 do not form connecting openings. In some embodiments, the plurality of leaflets 104 and / or connecting portions may be attached to the expandable framework 102 using sutures, adhesive, or other suitable methods.

[0045] In some embodiments, the replacement heart valve implant 100 may include an inner skirt 112. In some embodiments, the inner skirt 112 may form a substantially tubular shape. The inner skirt 112 may be disposed on a luminal surface of the expandable framework 102. The inner skirt 112 may direct fluid, such as blood, flowing through the replacement heart valve implant 100 toward the plurality of leaflets 104. The inner skirt 112 may ensure that fluid flows through the central lumen of the replacement heart valve implant 100 and that fluid does not flow around the plurality of leaflets 104 when the plurality of leaflets 104 is in the closed position.

[0046] The inner skirt 112 may include connecting protrusions that extend from the inner skirt 112 into one or more connecting openings. In some embodiments, the connecting protrusions may extend around a portion of the struts and / or the expandable framework 102. In some embodiments, the connecting protrusions may extend around a portion of the struts and into one or more connecting openings. In some embodiments, the connecting protrusions may interact with the expandable framework 102 to attach or bond the inner skirt 112 to the expandable framework 102 by a surface area contact structure and / or a form-fit structure. In some embodiments, the connecting protrusions may be attached to the expandable framework 102 using sutures, adhesives, or other suitable methods.

[0047] In some embodiments, the replacement heart valve implant 100 can include an outer skirt 114. In some embodiments, the outer skirt 114 can form a substantially tubular shape. In some embodiments, the outer skirt 114 can be disposed on an abluminal surface of the expandable framework 102. In some embodiments, the outer skirt 114 can be disposed between the expandable framework 102 and the vessel wall to prevent fluids, such as blood, from flowing around the replacement heart valve implant 100 and / or the expandable framework 102. The outer skirt 114 can ensure that fluids flow through the replacement heart valve implant 100 and not around the replacement heart valve implant 100, such as by ensuring that fluid flow can be stopped when the plurality of leaflets 104 are in a closed position.

[0048] The outer skirt 114 may include connecting protrusions that extend from the outer skirt 114 into one or more connecting openings. In some embodiments, the connecting protrusions may extend around a portion of the posts and / or the expandable framework 102. In some embodiments, the connecting protrusions may extend around a portion of the posts and / or the expandable framework 102 and into one or more connecting openings. In some embodiments, the connecting protrusions may interact with the expandable framework 102 to attach or bond the outer skirt 114 to the expandable framework 102, such as by a surface area contact structure or a form-fit structure. In some embodiments, the connecting protrusions may be attached to the expandable framework 102 using sutures, adhesive, or other suitable methods.

[0049] In some embodiments, the plurality of leaflets 104 may be constructed from a polymer, such as a thermoplastic polymer. In some embodiments, the plurality of leaflets 104 may comprise at least 50 weight percent polymer. In some embodiments, the plurality of leaflets 104 may be formed from bovine pericardium or other biological tissue. Other configurations and / or materials are also contemplated.

[0050] In some embodiments, inner skirt 112 may include a polymer, such as a thermoplastic polymer. In some embodiments, inner skirt 112 may include at least 50 weight percent polymer. In some embodiments, outer skirt 114 may include a polymer, such as a thermoplastic polymer. In some embodiments, outer skirt 114 may include at least 50 weight percent polymer. In some embodiments, one or more of leaflets 104, inner skirt 112, and / or outer skirt 114 may be formed from the same polymer or multiple polymers. In some embodiments, the polymer may be polyurethane. Some suitable, but non-limiting, examples of materials that may be used to form inner skirt 112 and / or outer skirt 114, including but not limited to polymers, composites, etc., are described below.

[0051] In some embodiments, the inner skirt 112 may be coupled to the lower crown 106 and / or the upper crown 108. In some embodiments, the inner skirt 112 may be coupled to only the upper crown 108. In some embodiments, the outer skirt 114 may be coupled to the lower crown 106 and / or the upper crown 108. In some embodiments, the outer skirt 114 may be coupled to only the lower crown 106. In some embodiments, the plurality of leaflets 104 may be coupled to the expandable framework 102 at or just below the plurality of stabilizing arches 110 and above the upper crown 108.

[0052] 2-4 illustrate selected aspects of an apparatus 200 for compressing a replacement heart valve implant 100. The apparatus 200 may include a tubular member 210 having a wall 212 with an outer surface 214 and an inner surface 216 that forms a lumen 218 of the tubular member 210, the tubular member 210 extending from a proximal end 204 of the tubular member 210 to a distal end 206 of the tubular member 210, as shown in FIG. 2. In some embodiments, the apparatus 200 and / or the tubular member 210 may include external threads formed on the outer surface 214 of the tubular member 210. Some suitable, but non-limiting, examples of materials that may be used to form the tubular member 210 are described below, including, but not limited to, metals and metal alloys, composites, ceramics, polymers, and the like. In some embodiments, the tubular member 210 may be formed from a polymeric material.

[0053] In some embodiments, the device 200 and / or tubular member 210 may include a plurality of longitudinal slots 222 formed in and / or extending through the wall 212 of the tubular member 210 from the outer surface 214 to the inner surface 216. In some embodiments, the plurality of longitudinal slots 222 may extend from the proximal end 204 of the tubular member 210 toward the distal end 206 of the tubular member 210. In some embodiments, the plurality of longitudinal slots 222 may begin at and / or extend from the proximal-most surface of the tubular member 210 toward the distal end 206 of the tubular member 210. In some embodiments, the device 200 and / or tubular member 210 may include a plurality of recesses 224 formed in the wall 212 and / or outer surface 214 of the tubular member 210. In at least some embodiments, the plurality of recesses 224 may taper radially inward in the distal direction. For example, the distal ends of the plurality of recesses 224 may extend radially inward a greater distance from the outer surface 214 than the proximal ends of the plurality of recesses 224. In some embodiments, the proximal ends of the plurality of recesses 224 may be distal to the proximal end 204 of the tubular member 210. In some embodiments, the proximal ends of the plurality of recesses 224 may be disposed within an intermediate region of the tubular member 210, and the distal ends of the plurality of recesses 224 may be disposed within a distal region of the tubular member 210. Other configurations are also contemplated.

[0054] In at least some embodiments, the inner surface 216 of the tubular member 210 may include a tapered portion 230 that tapers radially inward in the distal direction, as shown in the cross-sectional view of FIG. 3 . The device 200 may include a plurality of flexible arms 240 that project radially inward from the tapered portion 230 of the inner surface 216 of the tubular member 210. In some embodiments, the plurality of flexible arms 240 may include two flexible arms, three flexible arms, four flexible arms, or another suitable number of flexible arms. In some embodiments, the number of flexible arms may be a multiple of the number of leaflets in the plurality of leaflets 104. For example, if the plurality of leaflets 104 includes three leaflets, the plurality of flexible arms 240 may include three flexible arms, six flexible arms, etc. Other configurations are also contemplated. Some suitable, but non-limiting, examples of materials that may be used to form the plurality of flexible arms 240 are described below, including, but not limited to, metals and metal alloys, composites, ceramics, polymers, etc. In some embodiments, the plurality of flexible arms 240 may be formed from a polymeric material. In some embodiments, the plurality of flexible arms 240 may be formed from a monofilament polymeric material. In some embodiments, the plurality of flexible arms 240 may be formed from a different material than the tubular member 210. Other configurations are also contemplated.

[0055] In some embodiments, the plurality of flexible arms 240 may be circumferentially spaced apart about the central longitudinal axis 202 of the tubular member 210. In some embodiments, the plurality of flexible arms 240 may be equally spaced apart about the central longitudinal axis 202 of the tubular member 210. In some embodiments, the plurality of flexible arms 240 may be spaced apart approximately 120 degrees from one another, as shown in FIG. 4 , for example. Other configurations and / or spacings, such as equally and unevenly spaced, are also contemplated. In some embodiments, each of the plurality of flexible arms 240 may be circumferentially disposed between two circumferentially adjacent longitudinal slots of the plurality of longitudinal slots 222. As will become apparent, in some embodiments, the quantity of flexible arms and / or spacing between adjacent flexible arms of the plurality of flexible arms 240, as well as other elements, structures, and / or features, may be related to and / or dependent on the number of leaflets in the plurality of leaflets 104.

[0056] The plurality of flexible arms 240 may be attached and / or fixed to the wall 212 of the tubular member 210. In some embodiments, the plurality of flexible arms 240 may be fixedly attached to the wall 212 of the tubular member 210. For example, the plurality of flexible arms 240 may be adhesively bonded to the wall 212 of the tubular member 210, or the plurality of flexible arms 240 may be welded to the wall 212 of the tubular member 210. Other configurations are also contemplated.

[0057] In some embodiments, the plurality of flexible arms 240, in the unbiased configuration, at a location where the plurality of flexible arms 240 are attached and / or secured to the tubular member 210, may protrude radially inward from the inner surface 216 of the tubular member 210 at least 50% of the distance from the inner surface 216 of the tubular member 210 to the central longitudinal axis 202 of the tubular member 210. In some embodiments, the plurality of flexible arms 240, in the unbiased configuration, at a location where the plurality of flexible arms 240 are attached and / or secured to the tubular member 210, may protrude radially inward from the inner surface 216 of the tubular member 210 at least 75% of the distance from the inner surface 216 of the tubular member 210 to the central longitudinal axis 202 of the tubular member 210. In some embodiments, the plurality of flexible arms 240, in the unbiased configuration, at a location where the plurality of flexible arms 240 are attached and / or secured to the tubular member 210, may protrude radially inward from the inner surface 216 of the tubular member 210 at least 80% of the distance from the inner surface 216 of the tubular member 210 to the central longitudinal axis 202 of the tubular member 210. In some embodiments, the plurality of flexible arms 240, in the unbiased configuration, at a location where the plurality of flexible arms 240 are attached and / or secured to the tubular member 210, may protrude radially inward from the inner surface 216 of the tubular member 210 at least 85% of the distance from the inner surface 216 of the tubular member 210 to the central longitudinal axis 202 of the tubular member 210. In some embodiments, the multiple flexible arms 240, in their unbiased configuration, may protrude radially inward from the inner surface 216 of the tubular member 210 at least 90% of the distance from the inner surface 216 of the tubular member 210 to the central longitudinal axis 202 of the tubular member 210 at the position where the multiple flexible arms 240 are attached and / or fixed to the tubular member 210.

[0058] In some embodiments, the plurality of flexible arms 240 may extend from the inner surface 216 of the tubular member 210 distally within the lumen 218 of the tubular member 210 in the unbiased configuration. This can be seen most clearly in FIG. 3 . However, other configurations are also contemplated. For example, in some embodiments, the plurality of flexible arms 240 may extend radially inward from the inner surface 216 perpendicular to the central longitudinal axis 202 of the tubular member 210 in the unbiased configuration. In some embodiments, the plurality of flexible arms 240 may be curved and / or form an arc in the unbiased configuration. In some embodiments, the plurality of flexible arms 240 may be substantially straight in the unbiased configuration.

[0059] 5 , the apparatus 200 for compressing the replacement heart valve implant 100 may further include a push member 250 comprising an annular ring 252 and a plurality of extension members 254 extending radially inward from the annular ring 252. In at least some embodiments, the plurality of extension members 254 may extend radially inward to free ends. In some embodiments, the free ends of the plurality of extension members 254 may be spaced apart from one another about the center and / or central axis of the annular ring 252. The push member 250 and / or the annular ring 252 may be configured to slide over the outer surface 214 of the tubular member 210 and / or the external threads of the tubular member 210. In some embodiments, the plurality of extension members 254 can extend through the plurality of longitudinal slots 222 into the lumen 218 of the tubular member 210 as the push member 250 and / or the annular ring 252 slides over the outer surface 214 of the tubular member 210 and / or the external threads of the tubular member 210. Some suitable, but non-limiting, examples of materials that can be used to form the push member 250 are described below, including, but not limited to, metals and metal alloys, composites, ceramics, polymers, etc. In some embodiments, the push member 250 can be formed from a polymeric material.

[0060] The apparatus 200 for compressing the replacement heart valve implant 100 may further include a threaded nut 260 having internal threads configured to engage with external threads formed on the outer surface 214 of the tubular member 210. The threaded nut 260 may be configured to rotate about the tubular member 210. Rotation of the threaded nut 260 about the tubular member 210 may move and / or advance the threaded nut 260 distally along the outer surface 214 of the tubular member 210. Some suitable, but non-limiting, examples of materials that may be used to form the threaded nut 260 are described below, including, but not limited to, metals and metal alloys, composites, ceramics, polymers, etc. In some embodiments, the threaded nut 260 may be formed from a polymeric material.

[0061] In some embodiments, the push member 250 and the threaded nut 260 may be formed from the same material. In some embodiments, the push member 250 and the threaded nut 260 may be formed from different materials. In some embodiments, the push member 250 and / or the threaded nut 260 may be formed from the same material as the tubular member 210. In some embodiments, the push member 250 and / or the threaded nut 260 may be formed from a different material than the tubular member 210.

[0062] 6 is an exploded view illustrating aspects of a replacement heart valve system. In at least some embodiments, the replacement heart valve system may include a replacement heart valve implant 100 and an apparatus 200 for compressing the replacement heart valve implant 100. The replacement heart valve implant 100 may be inserted into the apparatus 200 as shown.

[0063] 6 may be used in a method of compressing a replacement heart valve implant 100. The method may include inserting the inflow end of the expandable framework 102 and / or the replacement heart valve implant 100 into the lumen 218 of the tubular member 210 of the apparatus 200 to compress the replacement heart valve implant 100, as generally shown in FIG. 6 . The method may include sliding the push member 250 over the proximal end 204 of the tubular member 210 until the plurality of extension members 254 engage with the plurality of commissures 116 of the replacement heart valve implant 100. When the push member 250 and / or the annular ring 252 engage and / or advance over the tubular member 210, the plurality of stabilizing arches 110 may be positioned between the plurality of extension members 254 such that the plurality of extension members 254 align with the plurality of commissures 116. The plurality of extension members 254 may advance within and / or extend through the plurality of longitudinal slots 222 as the annular ring 252 slides over the outer surface 214 of the tubular member 210 .

[0064] The push member 250 may be configured to push the replacement heart valve implant 100 through the lumen 218 of the tubular member 210. The plurality of extension members 254 may be configured to engage and / or push against the plurality of commissures 116 of the replacement heart valve implant 100 as the push member 250 pushes the replacement heart valve implant 100 through the tubular member 210. As the replacement heart valve implant 100 is pushed and / or advanced distally through the lumen 218 of the tubular member 210, the inner surface 216 and / or tapered portion 230 of the tubular member 210 gradually compress the expandable framework 102 and / or replacement heart valve implant 100 radially inward toward a delivery configuration, as shown in FIG.

[0065] The method may include disposing a threaded nut 260 on the proximal end 204 of the tubular member 210. As described herein, the threaded nut 260 may include female threads configured to engage with male threads formed on the outer surface 214 of the tubular member 210. The threaded nut 260 may be configured to rotate about the tubular member 210, thereby advancing the threaded nut 260 toward the distal end 206 of the tubular member 210. In some embodiments, a clockwise rotation of the threaded nut 260 about the tubular member 210 may advance the threaded nut 260 distally along the tubular member 210, when viewed from proximal to distal. A distal surface of the threaded nut 260 may be configured to engage a proximal surface of the push member 250 and / or the annular ring 252.

[0066] The method may include advancing the threaded nut 260 distally along and / or over the tubular member 210 to move the push member 250 distally along the tubular member 210, the push member 250 advancing the replacement heart valve implant 100 distally within the lumen 218 of the tubular member 210. By advancing the replacement heart valve implant 100 distally within the lumen 218 and / or tapered portion 230 of the tubular member 210, the expandable framework 102 and / or the replacement heart valve implant 100 may be radially compressed.

[0067] As the replacement heart valve implant 100 advances through the lumen 218 and / or tapered portion 230 of the tubular member 210 and passes through the plurality of flexible arms 240, the plurality of flexible arms 240 may be configured to push the plurality of leaflets 104 of the replacement heart valve implant 100 radially inward from the expandable framework 102 and / or the plurality of commissures 116 of the replacement heart valve implant 100 as the replacement heart valve implant 100 passes through the tubular member 210, as shown in Figures 8 and 9. The push member 250 and threaded nut 260 are not shown in Figures 8 and 9 for greater clarity; Figure 8 is shown in partial cross section and Figure 9 is an end view of the system in the position shown in Figure 8.

[0068] 9 , each of the plurality of flexible arms 240 may be circumferentially disposed between two circumferentially adjacent ones of the plurality of longitudinal slots 222. Thus, because the plurality of extension members 254 of the push member 250 extend through the plurality of longitudinal slots 222, each of the plurality of flexible arms 240 may be circumferentially disposed between two circumferentially adjacent ones of the plurality of extension members 254. The plurality of leaflets 104 and / or free edges of the plurality of leaflets 104 may be aligned with the plurality of flexible arms 240. As the upper crown 108 moves past the plurality of flexible arms 240, the plurality of flexible arms 240 may engage the plurality of leaflets 104 as the replacement heart valve implant 100 is advanced distally within the lumen 218 of the tubular member 210.

[0069] In at least some embodiments, each of the plurality of leaflets 104 may be engaged by only one of the plurality of flexible arms 240 as the replacement heart valve implant 100 passes through the lumen 218 of the tubular member 210, as shown in FIG. 9 . In some embodiments, each of the plurality of leaflets 104 may be engaged by two or more of the plurality of flexible arms 240, such as in embodiments having a number of flexible arms that is a multiple of the number of leaflets (e.g., three leaflets and six flexible arms, etc.). Other configurations are also contemplated. As shown in FIG. 9 , the plurality of flexible arms 240 may be configured to fold or assist in folding the plurality of leaflets 104 radially inward as the expandable framework 102 and / or replacement heart valve implant 100 are radially compressed toward the delivery configuration. Once the inflow end of the replacement heart valve implant 100 exits the distal end 206 of the tubular member 210, the expandable framework 102 and / or the replacement heart valve implant 100 may be in a delivery configuration, as shown in FIG.

[0070] In some embodiments, the expandable framework 102 and / or replacement heart valve implant 100 can be radially compressed from an outer diameter of about 23 millimeters (mm), about 25 mm, about 27 mm, about 30 mm, etc. in the unconstrained configuration to about 10 mm, about 9 mm, about 8 mm, about 7 mm, about 6 mm, etc. in the delivery configuration. Other configurations are also contemplated.

[0071] The various components of the apparatus and / or systems disclosed herein, as well as materials that can be used for the various elements thereof, can include materials commonly associated with medical devices. For ease of explanation, the following description will refer to systems. However, this is not intended to limit the devices and methods described herein, and the description may apply to other elements, members, components, or devices disclosed herein, such as, but not limited to, an expandable framework, an inner skirt, an outer skirt, multiple leaflets, a tubular member, a push member, a threaded nut, multiple flexible arms, and / or elements or components thereof.

[0072] In some embodiments, the system and / or its components may be made from metals, metal alloys, polymers (some examples of which are disclosed below), metal-polymer composites, ceramics, combinations thereof, etc., or other suitable materials.

[0073] Other examples of some suitable polymers include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, e.g., DELRIN® available from DuPont), polyether block esters, polyurethanes (e.g., Polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyether-esters (e.g., ARNITEL® available from DSM Engineering Plastics), ether- or ester-based copolymers (e.g., butylene / poly(alkylene ether) phthalates and / or other polyester elastomers, such as HYTREL® available from DuPont), polyamides (e.g., DURETHAN® available from Bayer, or CRISTAMID® available from Elf Atochem), elastomeric polyamides, block polyamide / ethers, polyether block amides (PEBA, e.g., available under the trade name PEBAX®), ethylene vinyl acetate copolymers (EVA). , silicone, polyethylene (PE), MARLEX® high density polyethylene, MARLEX® low density polyethylene, linear low density polyethylene (e.g., REXELL®), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyether ether ketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO) , polyparaphenylene terephthalamide (e.g., KEVLAR®), polysulfone, nylon, nylon-12 (such as GRILAMID® available from EMS American Grillon), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefin, polystyrene, epoxy, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS50A), polycarbonate, polyisobutylene (PIB),The sheath may include polyisobutylene polyurethane (PIBU), polyurethane-silicone copolymer (e.g., Elast-Eon® from Aortec Biomaterials or ChronoSil® from AdvanceSource Biomaterials), ionomer, biocompatible polymer, other suitable material, or mixtures, combinations, copolymers, polymer / metal composites, etc. In some embodiments, the sheath may be blended with a liquid crystal polymer (LCP). For example, the mixture may contain up to about 6% LCP.

[0074] Some examples of suitable metals and metal alloys include stainless steels, such as 304V, 304L, and 316LV stainless steel; mild steel; nickel-titanium alloys, such as linear elastic and / or superelastic nitinol; nickel-chromium-molybdenum alloys (e.g., UNS: N06625, such as INCONEL® 625; UNS: N06022, such as HASTELLOY® C-22®; HASTELLOY® C276®; and Nickel-copper alloys (e.g., UNS:N10276, other HASTELLOY® alloys, etc.), nickel-cobalt alloys (e.g., UNS:N04400, such as MONEL® 400, NICKELVAC® 400, NICORROS® 400, etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS:R30035, such as MP35-N®), nickel-molybdenum alloys (e.g., HASTELLOY® ALLOY Other nickel alloys such as UNS:N10665, such as 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; cobalt-chromium alloys; cobalt-chromium-molybdenum alloys (e.g., UNS:R30003, such as ELGILOY®, PHYNOX®); platinum-rich stainless steel; titanium; platinum; palladium; gold; combinations thereof; or any other suitable material.

[0075] In at least some embodiments, some or all of the system and / or components may also be doped with, made of, or include a radiopaque material. A radiopaque material is understood to be a material capable of producing a relatively bright image on a fluoroscopy screen or another imaging technique during a medical procedure. This relatively bright image assists the user of the system in determining its location. Some examples of radiopaque materials include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloys, polymeric materials loaded with radiopaque fillers, and the like. Additionally, other radiopaque marker bands and / or coils may be incorporated into the system design to achieve the same results.

[0076] In some embodiments, a degree of magnetic resonance imaging (MRI) compatibility is imparted to the systems and / or other elements disclosed herein. For example, the systems and / or components or portions thereof may be made of materials that do not substantially distort images or cause substantial artifacts (e.g., gaps in the images). For example, certain ferromagnetic materials may not be suitable because they may cause artifacts in MRI images. The systems or portions thereof may also be made of materials that can be imaged by MRI machines. Some materials that exhibit these properties include, for example, tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS:R30003, such as ELGILOY®, PHYNOX®, etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS:R30035, such as MP35-N®), nitinol, etc., and others.

[0077] In some embodiments, the systems and / or other elements disclosed herein may include a woven material disposed on or within the structure. The woven material may be composed of a biocompatible material, such as a polymeric material or a biomaterial adapted to promote tissue ingrowth. In some embodiments, the woven material may include a bioabsorbable material. Some examples of suitable woven materials include, but are not limited to, polyethylene glycol (PEG), nylon, polytetrafluoroethylene (PTFE, ePTFE), polyolefin-based materials such as polyethylene, polypropylene, polyester, polyurethane, and / or blends or combinations thereof.

[0078] In some embodiments, the systems and / or other elements disclosed herein may include and / or be formed from textile materials. Some examples of suitable textile materials include synthetic yarns, which may be flat, shaped, twisted, textured, pre-shrunk, or unshrunk. Synthetic biocompatible yarns suitable for use in the present disclosure include, but are not limited to, polyesters, including polyethylene terephthalate (PET) polyester, polypropylene, polyethylene, polyurethane, polyolefins, polyvinyls, polymethylacetates, polyamides, naphthalenedicarboxylic acid derivatives, natural silk, and polytetrafluoroethylene. Furthermore, at least one of the synthetic yarns may be a metal yarn, glass, or ceramic yarn or fiber. Useful metal yarns include yarns made from or containing stainless steel, platinum, gold, titanium, tantalum, or Ni-Co-Cr-based alloys. The yarns may further include carbon fiber, glass fiber, or ceramic fiber. Desirably, the threads are made from thermoplastic materials, including, but not limited to, polyester, polypropylene, polyethylene, polyurethane, polynaphthalene, polytetrafluoroethylene, etc. The threads may be of the multifilament, monofilament, or spun type. The type and denier of the thread selected may be selected to form a biocompatible and implantable prosthesis, and more particularly, a vascular structure, having desired properties.

[0079] In some embodiments, the systems and / or other elements disclosed herein may include and / or be treated with a suitable therapeutic agent. Some examples of suitable therapeutic agents include antithrombotic agents (such as heparin, heparin derivatives, urokinase, and PPack (dextrophenylalanine proline arginine chloromethyl ketone)); antiproliferative 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); antitumor / antiproliferative / antimitotic agents (such as paclitaxel, 5-fluorouracil, cisplatin, vinblastine, vincristine, epothilones, endostatin, angiostatin, and thymidine kinase inhibitors); anesthetic agents (such as lidocaine, bupivacaine, and ropivacaine); anticoagulants (such as D-Phe-Pro-Arg chloromethyl ketone, RGD peptide-containing compounds, heparin, antithrombin compounds, platelet receptor antagonists, antithrombin antibodies, antiplatelet receptor antibodies, aspirin, prostaglandin inhibitors, platelet inhibitors, and tick antiplatelet peptides); vascular cell growth promoters (such as growth factor inhibitors, growth factor receptor antagonists, transcription activators, and translation promoters); vascular cell growth inhibitors (such as growth factor inhibitors, growth factor receptor antagonists, transcription repressors, translation repressors, replication inhibitors, inhibitory antibodies, antibodies 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; vasodilators; and agents that interfere with endogenous vasoactive mechanisms.

[0080] It will be understood that this disclosure is, in many respects, merely illustrative. Changes may be made in details, particularly in matters of shape, size, and arrangement of steps, without exceeding the scope of the disclosure. This may include, to the extent appropriate, using any of the features of one illustrative embodiment in other embodiments. The scope of the disclosure is, of course, defined in the language in which the appended claims are expressed.

Claims

1. 1. An apparatus for compressing a replacement heart valve implant, the replacement heart valve implant including a plurality of circumferentially spaced commissures and a plurality of valve leaflets, each leaflet of the plurality of leaflets disposed between adjacent ones of the plurality of commissures, comprising: a tubular member having a wall, the wall having an outer surface and an inner surface forming a lumen of the tubular member, the inner surface including a tapered portion tapering radially inward in a distal direction; a plurality of flexible arms projecting radially inward from the tapered portion, each flexible arm of the plurality of flexible arms configured to engage one of the plurality of valve leaflets; a push member including an annular ring; a plurality of extension members extending radially inward from the annular ring, the plurality of extension members being circumferentially arranged such that each extension member of the plurality of extension members engages one commissure of the plurality of commissures; The device, wherein the plurality of flexible arms, in an unbiased configuration, project radially inward from the inner surface at least 50% of the distance from the inner surface to the central longitudinal axis of the tubular member.

2. 2. The device of claim 1, wherein the plurality of flexible arms, in an unbiased configuration, protrude radially inward from the inner surface at least 75% of the distance from the inner surface to the central longitudinal axis of the tubular member.

3. The device of claim 1 , wherein the plurality of flexible arms are fixedly attached to the wall of the tubular member.

4. The device of claim 1 , wherein the plurality of flexible arms are formed from a monofilament polymer material.

5. The device of claim 1 , wherein the plurality of flexible arms are formed from a different material than the tubular member.

6. a threaded nut configured to engage threads formed on the outer surface of the tubular member; The device of claim 1 , wherein the annular ring is configured to slide over the outer surface of the tubular member.

7. the tubular member includes a plurality of longitudinal slots extending through the wall; The device of claim 6 , wherein the plurality of extension members extend through the plurality of longitudinal slots into the lumen of the tubular member when the annular ring slides over the outer surface of the tubular member.

8. 1. A replacement heart valve system comprising: a replacement heart valve implant; and a device according to any one of claims 1 to 7, The replacement heart valve system, wherein the plurality of flexible arms are configured to urge the plurality of valve leaflets radially inward as the replacement heart valve implant passes through the tubular member.

9. 9. The replacement heart valve system of claim 8, wherein the plurality of flexible arms are equally circumferentially spaced about a central longitudinal axis of the tubular member.

10. 10. The replacement heart valve system of claim 9, wherein the flexible arms are spaced approximately 120 degrees apart from one another.

11. 9. The replacement heart valve system of claim 8, wherein each of the plurality of valve leaflets is engaged by only one of the plurality of flexible arms as the replacement heart valve implant passes through the tubular member.

12. The replacement heart valve system of claim 8, wherein the replacement heart valve system includes an expandable framework, the plurality of valve leaflets are fixed to the expandable framework at a plurality of commissures and include free edges extending between the plurality of commissures, and between circumferentially adjacent commissures, the replacement heart valve implant does not have the expandable framework at longitudinal positions radially outward of the free edges of the plurality of valve leaflets.

13. 1. A method of compressing a replacement heart valve implant, comprising: inserting the inflow end of the replacement heart valve implant into a device for compressing the replacement heart valve implant; a tubular member having a wall, the wall having an outer surface and an inner surface forming a lumen of the tubular member, the inner surface including a tapered portion tapering radially inward in a distal direction; a plurality of flexible arms projecting radially inward from the tapered portion, each flexible arm configured to engage one of a plurality of valve leaflets of the replacement heart valve implant; sliding a push member including an annular ring and a plurality of extension members extending radially inward from the annular ring over the proximal end of the tubular member until the plurality of extension members engage a plurality of commissures of the replacement heart valve implant; disposing a threaded nut on the proximal end of the tubular member, the threaded nut configured to engage threads formed on the exterior surface of the tubular member; and advancing the threaded nut distally along the tubular member to move the push member distally along the tubular member, wherein the push member advances the replacement heart valve implant distally within the lumen of the tubular member.

14. 14. The method of claim 13, wherein the plurality of flexible arms urge the plurality of valve leaflets of the replacement heart valve implant radially inward from an expandable framework of the replacement heart valve implant as the replacement heart valve implant is advanced through the plurality of flexible arms.

15. The method of claim 13 , wherein each of the plurality of flexible arms is circumferentially disposed between two circumferentially adjacent extension members of the plurality of extension members.

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