Replacement heart valve system with anti-migration element - Patent Application 20070122997

Abstract

The replacement heart valve system may include a replacement heart valve implant including an expandable framework configured to move from a radially contracted configuration to a radially expanded configuration and a plurality of valve leaflets attached to the expandable framework at a plurality of commissure posts, and an implant delivery system including a handle and an elongate shaft assembly. The elongate shaft assembly includes a tubular member fixedly attached to the handle and an implant retainer configured to restrain the expandable framework in the radially contracted configuration. The elongate shaft assembly includes an anti-migration element configured to move between the delivery configuration and the open configuration. The anti-migration element is configured to prevent proximal movement of the expandable framework relative to the tubular member in the open configuration.

Description

[Technical Field]

[0001] FIELD OF THE DISCLOSURE The present disclosure relates generally to medical devices, and more particularly to medical devices adapted for implanting stents and medical devices including stent components. [Background technology]

[0002] A wide variety of intracorporeal medical devices have been developed for medical applications, including prosthetic heart valves for repairing or replacing diseased heart valves. Prosthetic heart valves must be precisely aligned with the native valve annulus during implantation. Known medical devices and methods each have certain advantages and disadvantages. There is a continuing need to provide alternative medical devices and alternative methods for manufacturing and using medical devices. Summary of the Invention

[0003] In one example, a replacement heart valve system may include a replacement heart valve implant including an expandable framework configured to move from a radially contracted configuration to a radially expanded configuration and a plurality of valve leaflets attached to the expandable framework at a plurality of commissure posts, and an implant delivery system including a handle and an elongate shaft assembly. The elongate shaft assembly includes a tubular member fixedly attached to the handle and an implant retainer configured to restrain the expandable framework in the radially contracted configuration. The elongate shaft assembly may further include an anti-migration element configured to move between the delivery configuration and the open configuration. The anti-migration element may be configured to prevent proximal movement of the expandable framework relative to the tubular member in the open configuration.

[0004] In addition to or as an alternative to any of the examples disclosed herein, the anti-migration element can be engaged with a plurality of commissure posts. Additionally or alternatively to any example disclosed herein, the anti-migration element extends radially outward from the tubular member in the open configuration.

[0005] In addition to or in the alternative to any example disclosed herein, the anti-migration element includes an annular ring and a plurality of legs extending radially outward from the annular ring, the plurality of legs being engaged with a plurality of commissure posts.

[0006] Additionally or alternatively to any example disclosed herein, the annular ring is fixedly attached to the tubular member. Additionally or alternatively to any example disclosed herein, each leg of the plurality of legs extends radially outward of the plurality of commissure posts.

[0007] Additionally or alternatively to any example disclosed herein, the annular ring is positioned distal to the proximal-most portions of the plurality of legs when the anti-migration element is engaged with the plurality of commissure posts.

[0008] In addition to or in the alternative to any example disclosed herein, the plurality of legs extend longitudinally along the tubular member when the expandable framework is in a radially contracted configuration.

[0009] In addition to or in the alternative to any of the examples disclosed herein, a replacement heart valve system may include a replacement heart valve implant including an expandable framework configured to move from a radially contracted configuration to a radially expanded configuration, a plurality of valve leaflets attached to the expandable framework at a plurality of commissure posts, and an implant delivery system including a handle and an elongate shaft assembly. The elongate shaft assembly includes a tubular member fixedly attached to the handle and an implant holder configured to restrain the expandable framework in the radially contracted configuration. The elongate shaft assembly may further include an anti-migration element configured to move between the delivery configuration and the open configuration. The anti-migration element may be configured to prevent proximal movement of the expandable framework relative to the tubular member when the expandable framework is released from the implant holder.

[0010] In addition to or as an alternative to any example disclosed herein, a portion of the anti-migration element abuts a plurality of commissure posts. Additionally or alternatively to any example disclosed herein, the anti-migration element is not attached to the multiple commissure posts.

[0011] In addition to or as an alternative to any example disclosed herein, the implant delivery system can include a stent holder fixedly attached to the tubular member, the stent holder configured to engage a distal portion of the expandable framework when the expandable framework is restrained within the implant retainer.

[0012] Additionally or alternatively to any of the examples disclosed herein, the anti-migration element is positioned proximally relative to the stent holder. In addition to or in the alternative to any of the examples disclosed herein, a method of delivering a replacement heart valve implant to a native heart valve may include advancing an implant delivery system to a position adjacent to the native heart valve, wherein the replacement heart valve implant is restrained within an implant retainer of the implant delivery system, and deploying the replacement heart valve implant within the native heart valve. The replacement heart valve implant may include an expandable framework configured to move from a radially contracted configuration to a radially expanded configuration, and a plurality of valve leaflets attached to the expandable framework at a plurality of commissure posts. The implant delivery system may include a migration prevention element configured to move between the delivery configuration and the open configuration. The migration prevention element may be configured to prevent proximal migration of the expandable framework relative to the implant delivery system when the migration prevention element is in the open configuration.

[0013] In addition to or as an alternative to any of the examples disclosed herein, the step of deploying the replacement heart valve implant may further include moving a proximal sheath of the implant delivery system proximally relative to the replacement heart valve implant to release a proximal portion of the expandable framework, thereby allowing the proximal portion of the expandable framework to move toward the radially expanded configuration and the anti-migration element to move toward the open configuration, and then moving a distal sheath of the implant delivery system distally relative to the replacement heart valve implant to release a distal portion of the expandable framework, thereby allowing the distal portion of the expandable framework to move toward the radially expanded configuration.

[0014] Additionally or alternatively to any of the examples disclosed herein, the anti-migration element is fixedly attached to the tubular member of the implant delivery system at an attachment location located radially inward of the replacement heart valve implant.

[0015] In addition to or as an alternative to any of the examples disclosed herein, the anti-migration element extends proximally from the attachment location along the outer surface of the tubular member when the replacement heart valve implant is restrained within the implant holder.

[0016] In addition to or in the alternative to any of the examples disclosed herein, the method may further include, after deploying the replacement heart valve implant within the native heart valve, disengaging the anti-migration element from the expandable framework by retracting the implant delivery system proximally relative to the replacement heart valve implant.

[0017] In addition to or as an alternative to any example disclosed herein, after disengaging the anti-migration element from the expandable framework, the anti-migration element can be contracted radially inward to a retracted configuration in which the anti-migration element extends distally from the attached location.

[0018] Additionally or alternatively to any example disclosed herein, the anti-migration element may be biased toward the open configuration. 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] 1A-1D illustrate selected aspects of a replacement heart valve system. [Figure 3] 1A-1D illustrate selected aspects of a replacement heart valve system. [Figure 4]1A-1D illustrate selected aspects of an implant delivery system for a replacement heart valve system. [Figure 5] 1A-1D illustrate selected aspects of an implant delivery system for a replacement heart valve system. DETAILED DESCRIPTION OF THE INVENTION

[0020] While aspects of the present 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 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 disclosure. The detailed description and drawings depict exemplary embodiments of the disclosure.

[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.

[0023] 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, one 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 the disclosed embodiments. Each instance of a feature may include and / or be encompassed by the singular disclosure unless expressly stated to the contrary. For example, reference to a feature may also apply to all instances and quantities other than one of that feature unless expressly stated to the contrary. Thus, it will be understood that the following description may also apply to any and / or all components present in a plurality within a device, etc., unless expressly stated to the contrary.

[0025] Relative terms such as “proximal,” “distal,” “advancing,” “retracting,” 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 “retracting” indicating or referring to being closer to or toward the user, and “distal” and “advancing” 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 measure 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 measure 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 application, while a "minimum range" may be considered the smallest possible dimension measured according to the intended application. 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] 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 would be within the knowledge of one of ordinary skill in the art to implement 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 those skilled in the art.

[0029] 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.

[0030] Additionally, it should be noted that in any given figure, some features may not be shown or may be illustrated schematically for clarity and / or simplicity. Additional details regarding some components and / or method steps may be shown in more detail in other figures. The devices and / or methods disclosed herein can provide several desirable features and advantages, as described in more detail below.

[0031] 1 illustrates selected embodiments of a replacement heart valve implant 10. It should be understood that the replacement heart valve implant 10 can be any type of replacement heart valve (e.g., mitral valve, aortic valve, etc.). In use, the replacement heart valve implant 10 can be implanted (e.g., surgically or via transcatheter delivery) into the heart of a mammal. The replacement heart valve implant 10 can be configured to allow unidirectional flow through the replacement heart valve implant 10 from the inflow end to the outflow end.

[0032] For purposes of this disclosure, the description herein relates to use in treating a native heart valve, such as an aortic valve, and is so described for simplicity. However, this is not intended to be limiting, and those skilled in the art will recognize that the following description may be applied to other heart valves, blood vessels, and / or treatment sites within a patient with no or minimal alteration to the structure and / or scope of the present disclosure.

[0033] The replacement heart valve implant 10 may include an expandable framework 12 that forms a central lumen. In some embodiments, the expandable framework 12 may have a substantially circular cross-section. In some embodiments, the expandable framework 12 may have a non-circular cross-section (e.g., D-shaped, elliptical, etc.). Some suitable, but non-limiting, examples of materials that may be used to form the expandable framework 12 (including, but not limited to, metals and metal alloys, composites, ceramics, polymers, etc.) are described below. The expandable framework 12 may be configured to move between a radially collapsed configuration and a radially expanded configuration. In some embodiments, the expandable framework 12 may self-expand from the radially collapsed configuration to the radially expanded configuration. In some embodiments, the expandable framework 12 may be self-biased toward the radially expanded configuration. In some alternative embodiments, the expandable framework 12 may be mechanically expandable from the radially collapsed configuration to the radially expanded configuration. In some alternative embodiments, the expandable framework 12 may be balloon expandable from a radially contracted configuration to a radially expanded configuration. Other configurations are also contemplated. In some embodiments, the expandable framework 12 may include and / or define a plurality of interstices (e.g., openings) therethrough.

[0034] In some embodiments, the expandable framework 12 may include and / or define a lower crown 14 proximate the inflow end, an upper crown 16 proximate the outflow end, and a plurality of stabilizing arches 18 extending downstream from the outflow end. In some embodiments, the lower crown 14 may be disposed at the inflow end. In some embodiments, the upper crown 16 may be disposed at the outflow end. In some embodiments, the expandable framework 12 may include a tubular wall defining a central lumen, an inflow end, an outflow end, the lower crown 14, and / or the upper crown 16.

[0035] In some embodiments, the expandable framework 12 may include and / or define a plurality of commissure posts 17 proximate the outflow end. In some embodiments, the plurality of commissure posts 17 may at least partially define the outflow end. Other configurations are also contemplated. In some embodiments, the plurality of commissure posts 17 may be longitudinally and / or axially disposed between the upper crown 16 and the plurality of stabilizing arches 18. In some embodiments, the plurality of stabilizing arches 18 may extend downstream of the upper crown 16 and / or the plurality of commissure posts 17 and / or away from the upper crown 16 and / or the plurality of commissure posts 17 in a direction opposite the lower crown 14. In some embodiments, the upper crown 16 may be longitudinally and / or axially disposed between the lower crown 14 and the plurality of stabilizing arches 18. In some embodiments, the upper crown 16 may be longitudinally and / or axially disposed between the lower crown 14 and the plurality of stabilizing arches 18. In some embodiments, the upper crown 16 may be longitudinally and / or axially disposed between the lower crown 14 and the plurality of commissure posts 17.

[0036] In some embodiments, the replacement heart valve implant 10 may include a proximal portion and a distal portion. In some embodiments, the orientation of the replacement heart valve implant 10 may relate to the direction of implantation relative to the implant delivery device and / or target site. In some embodiments, the proximal portion may include an outflow end and / or multiple stabilizing arches 18. In some embodiments, the proximal portion may include multiple commissure posts 17, an upper crown 16, and / or multiple valve leaflets 20. In some embodiments, the distal portion may include an inflow end and / or a lower crown 14. Other configurations are contemplated.

[0037] In some embodiments, the replacement heart valve implant 10 can include multiple valve leaflets 20 disposed within the central lumen. The multiple valve leaflets 20 can be coupled, secured, and / or fixedly attached to the expandable framework 12. In at least some embodiments, the multiple valve leaflets 20 can be coupled, secured, and / or fixedly attached to the expandable framework 12 at multiple commissure posts 17 to form and / or define multiple commissures.

[0038] Each of the plurality of valve leaflets 20 may include a root edge coupled to the expandable framework 12 and a free edge (e.g., a coaptation edge) movable relative to the root edge to coapt with a free edge of another valve leaflet along a coaptation region. In some embodiments, the plurality of valve leaflets 20 may be integrally formed with one another such that the plurality of valve leaflets 20 are formed as a single, integral and / or monolithic unit. In some embodiments, the plurality of valve leaflets 20 may be integrally formed with other structures, such as the inner skirt 22 and / or outer skirt 24, a base structure, a liner, etc.

[0039] The plurality of valve leaflets 20 may be configured to substantially restrict fluid flow through the replacement heart valve implant 10 in the closed position. For example, in some embodiments, the free edges of the plurality of valve leaflets 20 may move together in the closed position to substantially restrict fluid flow through the replacement heart valve implant 10. The free edges of the plurality of valve leaflets 20 may move away from each other in the open position to allow fluid flow through the replacement heart valve implant 10. In FIG. 1 , the plurality of valve leaflets 20 are shown in an open or partially open position (e.g., a neutral position) to which the plurality of valve leaflets 20 may move when unbiased by fluid flow.

[0040] In some embodiments, the plurality of valve leaflets 20 may be constructed from a polymer (e.g., a thermoplastic polymer). In some embodiments, the plurality of valve leaflets 20 may comprise at least 50% polymer by weight. In some embodiments, the plurality of valve leaflets 20 may be formed from bovine pericardium or other biological tissue. Other configurations and / or materials are also contemplated.

[0041] In some embodiments, the replacement heart valve implant 10 may include an inner skirt 22 disposed on and / or extending along the inner surface of the expandable framework 12. In at least some embodiments, the inner skirt 22 may be fixedly attached to the expandable framework 12. The inner skirt 22 may direct fluid, such as blood, flowing through the replacement heart valve implant 10 toward the plurality of valve leaflets 20. In at least some embodiments, the inner skirt 22 may be fixedly attached to and / or integrally formed with the plurality of valve leaflets 20. The inner skirt 22 may ensure that fluid flows through a central lumen of the replacement heart valve implant 10 and that fluid does not flow around the plurality of valve leaflets 20 when in the closed position.

[0042] In some embodiments, the replacement heart valve implant 10 may include an outer skirt 24 disposed on and / or extending along the outer surface of the expandable framework 12. In some embodiments, the outer skirt 24 may be disposed on and / or adjacent to the lower crown 14. In some embodiments, the outer skirt 24 may be disposed between the expandable framework 12 and the vessel wall to prevent fluids, such as blood, from flowing downstream around the replacement heart valve implant 10 and / or the expandable framework 12. The outer skirt 24 may ensure that fluids can flow through the replacement heart valve implant 10 and not around the replacement heart valve implant 10, for example, to ensure that fluid flow can be stopped when the plurality of valve leaflets 20 are in a closed position.

[0043] In some embodiments, the inner skirt 22 can include a polymer, such as a thermoplastic polymer. In some embodiments, the inner skirt 22 can include at least 50 weight percent of the polymer. In some embodiments, the outer skirt 24 can include a polymer, such as a thermoplastic polymer. In some embodiments, the outer skirt 24 can include at least 50 weight percent of the polymer. In some embodiments, one or more of the plurality of valve leaflets 20, the inner skirt 22, and / or the outer skirt 24 can be formed from the same polymer or polymers. In some embodiments, the polymer can be polyurethane.

[0044] In some embodiments, the inner skirt 22 and / or the outer skirt 24 may be substantially impermeable to fluids. In some embodiments, the inner skirt 22 and / or the outer skirt 24 may be formed from thin tissue (e.g., bovine pericardium, etc.). In some embodiments, the inner skirt 22 and / or the outer skirt 24 may be formed from a coated woven material. In some embodiments, the inner skirt 22 and / or the outer skirt 24 may be formed from a non-porous and / or impermeable woven material. Other configurations are also contemplated. Some suitable, but non-limiting, examples of materials that may be used to form the inner skirt 22 and / or the outer skirt 24 (including, but not limited to, polymers, composites, etc.) are described below.

[0045] In some embodiments, the inner skirt 22 and / or the outer skirt 24 may seal one, some, more than one, or each of a plurality of gaps formed in the expandable framework 12. In at least some embodiments, sealing the gaps may be considered to prevent fluid from flowing through the gaps in the expandable framework 12. In some embodiments, the inner skirt 22 and / or the outer skirt 24 may be attached to the expandable framework 12 and / or a plurality of frame struts using one or more methods (including, but not limited to, suture or filament tying, adhesive bonding, fusion bonding, embedding or overmolding, welding, etc.).

[0046] In some embodiments, the replacement heart valve implant 10 may include a sealing member disposed on the expandable framework 12 adjacent the inflow end. In some embodiments, the sealing member may include and / or be the inner skirt 22. In some embodiments, the sealing member may include and / or be the outer skirt 24. In some embodiments, the sealing member may include and / or be the inner skirt 22 and the outer skirt 24. Other configurations are contemplated.

[0047] In some embodiments, the expandable framework 12 and / or replacement heart valve implant 10 can have an exterior in an unconstrained configuration (e.g., a radially expanded configuration) of about 23 millimeters (mm), about 25 mm, about 27 mm, about 30 mm, etc. In some embodiments, the expandable framework 12 and / or replacement heart valve implant 10 can have an exterior in a radially contracted configuration of about 10 mm, about 9 mm, about 8 mm, about 7 mm, about 6 mm, etc. Other configurations are also contemplated.

[0048] 2-5 illustrate selected embodiments of a replacement heart valve system including a replacement heart valve implant 10 and an implant delivery system 30 for delivering the replacement heart valve implant to a native heart valve (e.g., an aortic valve). The implant delivery system 30 may be compatible with and / or usable with the replacement heart valve implant 10. In FIG. 2, some elements not normally displayed are shown in phantom lines to illustrate relative positioning. In FIGS. 2-3, only the expandable framework 12 of the replacement heart valve implant 10 is shown. Other elements of the replacement heart valve implant 10 have been omitted for clarity. Note also that FIGS. 2-3 include at least one scale change (e.g., not all portions of the figures are drawn to the same scale) to improve visibility and to show additional details of selected embodiments of the implant delivery system 30.

[0049] The implant delivery system 30 may include a handle 40 and an elongate shaft assembly 50 extending distally from the handle 40. The handle 40 may include a first end 42 and a second end 44 opposite the first end 42. The elongate shaft assembly 50 may extend distally from the second end 44 of the handle 40. The handle 40 may include one or more rotatable knobs. In some embodiments, the one or more rotatable knobs may include a first rotatable knob and a second rotatable knob. In at least some embodiments, the first rotatable knob and / or the second rotatable knob may be configured to rotate about a central longitudinal axis of the implant delivery system 30 and / or the handle 40.

[0050] In some embodiments, the distal portion of the implant delivery system 30 and / or elongate shaft assembly 50 may include an implant retainer 60 configured to engage and / or restrain the replacement heart valve implant 10 and / or expandable framework 12 in a radially contracted configuration, as shown in Figure 2. The elongate shaft assembly 50 may comprise a tubular member fixedly attached to the handle 40.

[0051] In some embodiments, the elongate shaft assembly 50 can include an outer tubular member 52 extending distally from the handle 40 and an inner shaft 54 ​​extending distally from the handle 40 within the outer tubular member 52 to a distal tip 58 disposed distally of the implant holder 60. In some embodiments, the implant holder 60 can include a proximal sheath 62 and a distal sheath 64. In some embodiments, the proximal sheath 62 and / or the distal sheath 64 can be formed from a polymeric material. In some embodiments, the proximal sheath 62 and / or the distal sheath 64 can include a reinforcing structure disposed therein and / or thereon. In some embodiments, the reinforcing structure can be a coil, a mesh, one or more filaments, bands, or strips, or other suitable structure. Other configurations are also contemplated.

[0052] In some embodiments, the inner shaft 54 ​​can be slidably disposed within the lumen of the outer tubular member 52. In some embodiments, the tubular member fixedly attached to the elongate shaft assembly 50 and / or handle 40 can include an intermediate tubular member 56 disposed within and / or radially inward of the outer tubular member 52 and disposed around and / or radially outward of the inner shaft 54. In some embodiments, the inner shaft 54 ​​can be slidably disposed within the lumen of the tubular member, the outer tubular member 52, and / or the intermediate tubular member 56. In at least some embodiments, the inner shaft 54 ​​and the outer tubular member 52 are each axially translatable relative to the intermediate tubular member 56 independently of one another. For example, the inner shaft 54 ​​can translate relative to the intermediate tubular member 56 without translating the outer tubular member 52 relative to the intermediate tubular member 56, or vice versa.

[0053] In some embodiments, the proximal sheath 62 may be fixedly attached to the outer tubular member 52. In some embodiments, the proximal sheath 62 may be fixedly attached to the distal end of the outer tubular member 52 and / or may extend distally from the distal end of the outer tubular member 52. In some embodiments, the distal sheath 64 and / or the distal tip 58 may be fixedly attached to the inner shaft 54. In some embodiments, the distal sheath 64 may be fixedly attached to the distal tip 58. In some embodiments, the distal sheath 64 may extend proximally from the distal tip 58. In some embodiments, the inner shaft 54 ​​may include and / or at least partially define a guidewire lumen extending therethrough. In some embodiments, the guidewire lumen may extend through the handle 40.

[0054] In some embodiments, the handle 40 can be configured to manipulate and / or translate the proximal sheath 62 and / or the distal sheath 64 relative to one another using the first rotatable knob and / or the second rotatable knob. In some embodiments, the handle 40 can be configured to manipulate and / or translate the inner shaft 54 ​​and / or the distal sheath 64 relative to the elongate shaft assembly 50, the outer tubular member 52, the intermediate tubular member 56, and / or the proximal sheath 62. In some embodiments, the handle 40 can be configured to manipulate and / or translate the outer tubular member 52 and / or the proximal sheath 62 relative to the elongate shaft assembly 50, the inner shaft 54, the intermediate tubular member 56, and / or the distal sheath 64.

[0055] During delivery of the replacement heart valve implant 10 to a treatment site (e.g., a native heart valve, an aortic valve, etc.), the replacement heart valve implant 10 and / or the expandable framework 12 may be at least partially disposed within the proximal sheath 62 and / or the distal sheath 64 in a radially contracted configuration when the implant holder 60 is in the closed configuration (e.g., FIG. 2 ). In some embodiments, the proximal sheath 62 and / or the distal sheath 64 may collectively form the implant holder 60 of the implant delivery system 30. In some embodiments, the implant holder 60 may be configured to constrain the replacement heart valve implant 10 and / or the expandable framework 12 in the radially contracted configuration when the implant holder 60 is in the closed configuration (e.g., FIG. 2 ). In some embodiments, the replacement heart valve implant 10 and / or the expandable framework 12 may be releasably coupled to the inner shaft 54, the intermediate tubular member 56, and / or the stent holder 70 (described in more detail below) when the replacement heart valve implant 10 and / or the expandable framework 12 is restrained in a radially contracted configuration within the implant retaining portion 60 of the implant delivery system 30.

[0056] In some embodiments, the proximal sheath 62 may be configured to cover the proximal portion and / or outflow end of the replacement heart valve implant 10 and / or expandable framework 12 in a radially contracted configuration when the implant retaining portion 60 is in the closed configuration, and the distal sheath 64 may be configured to cover the distal portion and / or inflow end of the replacement heart valve implant 10 and / or expandable framework 12 in a radially contracted configuration when the implant retaining portion 60 is in the closed configuration. In some embodiments, the proximal sheath 62 may be disposed adjacent to the distal sheath 64 in the closed configuration. In some embodiments, the proximal sheath 62 may abut the distal sheath 64 in the closed configuration. In some embodiments, the proximal sheath 62 may be axially spaced from the distal sheath 64 in the closed configuration. In some embodiments, the proximal sheath 62 may be axially spaced from the distal sheath 64 by less than 20% of the overall length of the replacement heart valve implant 10 and / or expandable framework 12 in the closed configuration. In some embodiments, the proximal sheath 62 can be spaced axially from the distal sheath 64 by less than 15% of the overall length of the replacement heart valve implant 10 and / or expandable framework 12 in the closed configuration. In some embodiments, the proximal sheath 62 can be spaced axially from the distal sheath 64 by less than 10% of the overall length of the replacement heart valve implant 10 and / or expandable framework 12 in the closed configuration. In some embodiments, the proximal sheath 62 can be spaced axially from the distal sheath 64 by less than 5% of the overall length of the replacement heart valve implant 10 and / or expandable framework 12 in the closed configuration. Other configurations are contemplated.

[0057] After advancing the replacement heart valve system and / or implant delivery system 30 to a position adjacent to the native heart valve (e.g., the aortic valve), the replacement heart valve implant 10 and / or expandable framework 12 may be deployed within the native heart valve (e.g., the aortic valve). Deploying the replacement heart valve implant 10 and / or expandable framework 12 may include moving the proximal sheath 62 and the distal sheath 64 of the implant holder 60 from a closed configuration to an open configuration, as shown in FIG. 3 . In some embodiments, moving the proximal sheath 62 and the distal sheath 64 of the implant holder 60 from a closed configuration to an open configuration may include moving the proximal sheath 62 and the distal sheath 64 of the implant holder 60 axially away from each other.

[0058] In some embodiments, the implant holder 60 and / or the elongate shaft assembly 50 may include a stent holder 70, as shown in FIG. 3 . In at least some embodiments, the stent holder 70 may be fixedly attached to the elongate shaft assembly 50. In some embodiments, the stent holder 70 may be fixedly attached to the intermediate tubular member 56 of the elongate shaft assembly 50. In some embodiments, the stent holder 70 may be integrally formed with the elongate shaft assembly 50 and / or the intermediate tubular member 56. In some embodiments, the stent holder 70 may be configured to engage the expandable framework 12 in the radially contracted configuration and / or when the replacement heart valve implant 10 is restrained within the implant holder 60 of the implant delivery system 30. In some embodiments, the stent holder 70 may include at least one protrusion 73 configured to engage the expandable framework 12 in the radially contracted configuration. In some embodiments, the at least one protrusion 73 may be configured to engage the inflow end of the expandable framework 12 in the radially contracted configuration. In some embodiments, the at least one protrusion 73 can extend into and / or through interstices in the expandable framework 12. In some embodiments, the expandable framework 12 can include at least one mounting loop configured to receive and / or engage the at least one protrusion 73. Other configurations are contemplated.

[0059] The implant delivery system 30 and / or the elongate shaft assembly 50 may include a primary visual indicator 76 (e.g., FIGS. 3-4 ) disposed within the replacement heart valve implant 10 when the replacement heart valve implant 10 and / or the expandable framework 12 are restrained within the implant retainer 60 in a radially contracted configuration. The primary visual indicator 76 may be configured and / or adapted to be visible under fluoroscopy using an imaging device. Other imaging modalities suitable for use in transcatheter surgical procedures are also contemplated. The implant delivery system 30 and / or the primary visual indicator 76 may be configured to cooperate with the imaging device to position the replacement heart valve implant 10 at a desired insertion depth within the native heart valve (e.g., the aortic valve). In some embodiments, the primary visual indicator 76 may be fixedly attached to the elongate shaft assembly 50 and / or the intermediate tubular member 56 by shrink wrap or by an adhesive element. In some embodiments, the primary visual indicator 76 may be and / or include a marker band. In some embodiments, the primary visual indicator 76 may be at least partially radiopaque. In some embodiments, the primary visual indicator 76 may be completely radiopaque. Other configurations are contemplated.

[0060] In use, the implant delivery system 30 can be advanced to a location adjacent to a treatment site (e.g., a native heart valve). In one example, the implant delivery system 30 can be advanced through the vasculature, across the aortic arch, and to a location adjacent to a native heart valve (e.g., an aortic valve). Alternative approaches to treating defective aortic valves and / or other heart valve(s) are also contemplated by the implant delivery system 30.

[0061] The desired insertion depth may be selected to maximize the outward radial force of the expandable framework 12 within the native heart valve (e.g., aortic valve). By positioning the replacement heart valve implant 10 at the desired insertion depth and / or within the maximum allowable range of the desired insertion depth, the replacement heart valve implant 10 and / or the expandable framework 12 may exhibit optimal arch formation within the native heart valve (e.g., aortic valve), thereby preventing downstream (or upstream) migration of the replacement heart valve implant 10 and / or the expandable framework 12.

[0062] Positioning the replacement heart valve implant 10 and / or expandable framework 12 within the native heart valve (e.g., aortic valve) may be accomplished by locating the primary visual indicator 76 relative to the native heart valve (e.g., aortic valve). During visualization, the native heart valve (e.g., aortic valve) may be identified and / or visualized under fluoroscopy using known means and / or methods, such as contrast injection.

[0063] In some embodiments, the implant delivery system 30 and / or the elongate shaft assembly 50 may include a stent holder 70 configured to engage the expandable framework 12 of the replacement heart valve implant 10 in a radially contracted configuration and / or when the replacement heart valve implant 10 is restrained within the implant retaining portion 60 of the implant delivery system 30. In some embodiments, the stent holder 70 may include a body, a first end extending proximally from the body, and a second end disposed opposite the first end. In some embodiments, at least a portion of the first end may extend radially outward from and / or radially outward from the body. In some embodiments, the first end may have a generally bulbous shape. In some embodiments, the stent holder 70 may be configured and / or adapted to be visible under fluoroscopy. In some embodiments, the stent holder 70 may be formed from stainless steel. Some suitable, but non-limiting, materials for the stent holder 70 and / or its components or elements are described below.

[0064] In some embodiments, the outermost radial extent of the first end of the stent holder 70 can be disposed proximal to the distal end of the first end of the stent holder 70. In some embodiments, the first end of the stent holder 70 can taper radially inward from the outermost radial extent of the stent holder 70 in a proximal direction. In some embodiments, the stent holder 70 can include a lumen extending longitudinally and / or axially through the stent holder 70. In at least some embodiments, at least a portion of the elongate shaft assembly 50 can extend longitudinally and / or axially through the lumen of the stent holder 70.

[0065] The first end may be configured and / or adapted to engage the expandable framework 12 of the replacement heart valve implant 10 in a radially contracted configuration and / or when the replacement heart valve implant 10 is restrained within the implant retaining portion 60 of the implant delivery system 30. In some embodiments, the first end may include at least one protrusion 73 configured and / or adapted to engage the expandable framework 12 of the replacement heart valve implant 10 in a radially contracted configuration and / or when the replacement heart valve implant 10 is restrained within the implant retaining portion 60 of the implant delivery system 30. In some embodiments, the at least one protrusion 73 may extend radially outward from the first end of the stent holder 70.

[0066] In some embodiments, the implant delivery system 30 and / or the implant holder 60 can include an atraumatic transition shield 79, shown in FIG. 3 . The atraumatic transition shield 79 can be positioned adjacent to the stent holder 70. In some embodiments, the atraumatic transition shield 79 can be positioned between the stent holder 70 and the handle 40. In some embodiments, the atraumatic transition shield 79 can be positioned proximally relative to the stent holder 70. In some embodiments, the atraumatic transition shield 79 can be positioned at and / or adjacent to the first end of the stent holder 70. In some embodiments, the atraumatic transition shield 79 can axially overlap the first end of the stent holder 70. In some embodiments, the atraumatic transition shield 79 can be positioned radially outward of at least a portion of the first end of the stent holder 70. In some embodiments, the atraumatic transition shield 79 may taper downstream and / or proximally and / or radially inward toward the handle 40. The atraumatic transition shield 79 may be configured to prevent the replacement heart valve implant 10, the expandable framework 12, the plurality of valve leaflets 20, etc. from getting caught on the stent holder 70 when the implant delivery system 30 is withdrawn after deploying the replacement heart valve implant 10.

[0067] In some embodiments, the primary visual indicator 76 may be positioned adjacent the proximal end of the atraumatic transition shield 79. In some embodiments, the primary visual indicator 76 may be positioned downstream and / or proximal of the atraumatic transition shield 79. In some embodiments, the primary visual indicator 76 and the atraumatic transition shield 79 may axially overlap. In some embodiments, the primary visual indicator 76 may be fixedly attached to the elongate shaft assembly 50. In some embodiments, the primary visual indicator 76 may be embedded in the elongate shaft assembly 50 and / or the intermediate tubular member 56. In some embodiments, the primary visual indicator 76 may be fixedly attached to the intermediate tubular member 56 by, for example, adhesive bonding, welding, shrink wrapping, etc. Other configurations are also contemplated.

[0068] In some embodiments, the elongate shaft assembly 50 can include an anti-migration element 80 configured to move between a delivery configuration (e.g., FIG. 2) and an open configuration (e.g., FIGS. 3-4). In some embodiments, the anti-migration element 80 can be further configured to move between a delivery configuration (e.g., FIG. 2), an open configuration (e.g., FIGS. 3-4), and a withdrawal configuration (e.g., FIG. 5).

[0069] The migration prevention element 80 may be configured to prevent downstream and / or proximal migration of the replacement heart valve implant 10 and / or the expandable framework 12 relative to the tubular member (e.g., the intermediate tubular member 56) in the open configuration. In at least some embodiments, the migration prevention element 80 may be configured to prevent downstream and / or proximal migration of the replacement heart valve implant 10 and / or the expandable framework 12 relative to the tubular member (e.g., the intermediate tubular member 56) when the replacement heart valve implant 10 and / or the expandable framework 12 are released from the implant holder 60.

[0070] As shown in Figures 2-3, the migration preventing element 80 can be configured to engage multiple commissure posts 17. In some embodiments, the migration preventing element 80 can extend radially outward from the tubular member (e.g., intermediate tubular member 56). In some embodiments, the migration preventing element 80 can extend radially outward from the tubular member (e.g., intermediate tubular member 56) in the delivery configuration, the release configuration, and / or the withdrawal configuration. The migration preventing element 80 can be fixedly attached to the tubular member (e.g., intermediate tubular member 56) at the attachment location.

[0071] As shown most clearly in FIG. 4 , the migration preventing element 80 may include an annular ring 82 and a plurality of legs 84 extending radially outward from the annular ring 82. As shown in FIGS. 2-3 , the plurality of legs 84 of the migration preventing element 80 may be configured to engage a plurality of commissure posts 17. For example, the plurality of legs 84 of the migration preventing element 80 may be configured to engage a plurality of commissure posts 17 in the delivery configuration and / or the open configuration. The annular ring 82 of the migration preventing element 80 may be fixedly secured to and / or fixedly attached to a tubular member (e.g., the intermediate tubular member 56) at an attachment location. The attachment location may be located radially inward of the replacement heart valve implant 10 and / or the expandable framework 12 in the delivery configuration (e.g., when the replacement heart valve implant 10 and / or the expandable framework 12 are constrained within the implant retaining portion 60) and / or in the open configuration (e.g., when the replacement heart valve implant 10 and / or the expandable framework 12 are released from the implant retaining portion 60). Thus, anti-migration element 80 and / or annular ring 82 of anti-migration element 80 are prevented from translating, sliding, etc. along and / or relative to a tubular member (e.g., intermediate tubular member 56).

[0072] Each leg of the plurality of legs 84 of the migration preventing element 80 can extend radially outward from the annular ring 82 of the migration preventing element 80. In at least some embodiments, each leg of the plurality of legs 84 of the migration preventing element 80 can be configured to extend radially outward from the plurality of commissure posts 17. In some embodiments, each leg of the plurality of legs 84 of the migration preventing element 80 can extend radially outward from the plurality of commissure posts 17 in the delivery configuration. In some embodiments, each leg of the plurality of legs 84 of the migration preventing element 80 can extend radially outward from the plurality of commissure posts 17 in the open configuration. In some embodiments, each leg of the plurality of legs 84 of the migration preventing element 80 can extend radially outward from the plurality of commissure posts 17 in both the delivery configuration and the open configuration.

[0073] In at least some embodiments, migration preventing element 80 can be positioned downstream and / or proximal of stent holder 70 in the delivery configuration and / or in the open configuration. In some embodiments, migration preventing element 80 can be positioned downstream and / or proximal of atraumatic transition shield 79 in the delivery configuration and / or in the open configuration. In some embodiments, migration preventing element 80 can be positioned downstream and / or proximal of primary visual indicator 76 in the delivery configuration and / or in the open configuration. In some embodiments, annular ring 82 of migration preventing element 80 can be positioned downstream and / or proximal of stent holder 70.

[0074] In some embodiments, the annular ring 82 of the migration preventing element 80 may be positioned upstream and / or distal to the plurality of commissure posts 17 in the delivery configuration and / or when the replacement heart valve implant 10 and / or expandable framework 12 is constrained within the implant holder 60. In some embodiments, the annular ring 82 of the migration preventing element 80 may be positioned upstream and / or distal to the plurality of commissure posts 17 in the open configuration (e.g., during release of the replacement heart valve implant 10 and / or expandable framework 12 from the implant holder 60). In some embodiments, the annular ring 82 of the migration preventing element 80 may be positioned upstream and / or distal to the downstream-most end and / or the proximal-most end of the plurality of commissure posts 17 in the delivery configuration and / or when the replacement heart valve implant 10 and / or expandable framework 12 is constrained within the implant holder 60. In some embodiments, the annular ring 82 of the anti-migration element 80 can be positioned upstream and / or distal to the downstream-most and / or proximal-most ends of the plurality of commissure posts 17 in the open configuration (e.g., during release of the replacement heart valve implant 10 and / or expandable framework 12 from the implant holder 60). Thus, in some embodiments, the plurality of commissure posts 17 extend downstream and / or proximal to the annular ring 82 of the anti-migration element 80 in the delivery configuration and / or the open configuration.

[0075] In some embodiments, the legs 84 of the migration preventing element 80 extend downstream and / or proximally from the annular ring 82 of the migration preventing element 80 in the delivery configuration (e.g., FIG. 2) and / or the open configuration (e.g., FIGS. 3-4). In some embodiments, each leg of the legs 84 of the migration preventing element 80 is coupled to, fixed to, and / or fixedly attached to the annular ring 82 at the attachment end. Each leg of the legs 84 of the migration preventing element 80 may include a free end opposite the attachment end. In some embodiments, the legs 84 of the migration preventing element 80 extend downstream and / or proximally from the attachment end in the delivery configuration and / or the open configuration. In some embodiments, the free end may be located downstream and / or proximal of the attachment end and / or the annular ring 82 of the migration preventing element 80 in the delivery configuration. In some embodiments, the free end may be located downstream and / or proximal of the mounting end of the anti-migration element 80 and / or the annular ring 82 in the open configuration. Other configurations are also contemplated.

[0076] In some embodiments, a portion of the migration preventing element 80 can abut the commissure posts 17 in the delivery configuration and / or the open configuration. In some embodiments, the legs 84 of the migration preventing element 80 can abut the commissure posts 17 in the delivery configuration and / or the open configuration. In some embodiments, the migration preventing element 80 and / or the legs 84 of the migration preventing element 80 are in direct contact with the commissure posts 17 in the delivery configuration and / or the open configuration.

[0077] In at least some embodiments, the migration preventing element 80 is not attached to the plurality of commissure posts 17 in the delivery configuration and / or in the open configuration. In some embodiments, the migration preventing element 80 is not locked and / or interlocked with the plurality of commissure posts 17 in the delivery configuration and / or in the open configuration. In some embodiments, the legs 84 of the migration preventing element 80 are not attached to the plurality of commissure posts 17 in the delivery configuration and / or in the open configuration. In some embodiments, the legs 84 of the migration preventing element 80 are not locked and / or interlocked with the plurality of commissure posts 17 in the delivery configuration and / or in the open configuration.

[0078] In some embodiments, the annular ring 82 of the migration preventing element 80 is positioned upstream of and / or distal to the downstream-most portion and / or extent of the plurality of legs 84 of the migration preventing element 80 when the migration preventing element 80 is engaged with the plurality of commissure posts 17. In some embodiments, the annular ring 82 of the migration preventing element 80 is positioned upstream of and / or distal to the downstream-most portion and / or extent of the proximal-most portion and / or extent of the plurality of legs 84 of the migration preventing element 80 when the migration preventing element 80 is engaged with the plurality of commissure posts 17 in the delivery configuration. In some embodiments, the annular ring 82 of the anti-migration element 80 is positioned upstream of the downstream-most portion and / or the downstream-most extent of the multiple legs 84 of the anti-migration element 80 and / or distal of the proximal-most portion and / or the proximal-most extent of the multiple legs 84 when the anti-migration element 80 is engaged with the multiple commissure posts 17 in the open configuration.

[0079] In some embodiments, the legs 84 of the migration preventing element 80 may extend longitudinally along and / or along the outer surface of a tubular member (e.g., the intermediate tubular member 56) when the replacement heart valve implant 10 and / or the expandable framework 12 are constrained in a radially contracted configuration. In some embodiments, the legs 84 of the migration preventing element 80 may extend downstream and / or proximally along and / or along the outer surface of a tubular member (e.g., the intermediate tubular member 56) when the replacement heart valve implant 10 and / or the expandable framework 12 are constrained in a radially contracted configuration. In some embodiments, the legs 84 of the migration preventing element 80 may extend longitudinally along and / or along the outer surface of a tubular member (e.g., the intermediate tubular member 56) when the migration preventing element 80 is in a delivery configuration, as shown in FIG. 2 . In some embodiments, the multiple legs 84 of the migration prevention element 80 may extend downstream and / or proximally along and / or along the outer surface of a tubular member (e.g., intermediate tubular member 56) when the migration prevention element 80 is in the delivery configuration.

[0080] In some embodiments, the migration preventing element 80 and / or the legs 84 of the migration preventing element 80 may be biased toward the open configuration. In at least some embodiments, the migration preventing element 80 and / or the legs 84 of the migration preventing element 80 may be self-biased toward the open configuration. Thus, when no external force acts on the migration preventing element 80 and / or the legs 84 of the migration preventing element 80, the migration preventing element 80 and / or the legs 84 of the migration preventing element 80 "snap" into the open configuration. In some embodiments, the migration preventing element 80 and / or the legs 84 of the migration preventing element 80 may be formed from a shape memory material that is heat set in the open configuration. Other configurations are contemplated.

[0081] In some embodiments, the migration preventing element 80 and / or the legs 84 of the migration preventing element 80 may be biased toward the open configuration by one or more springs. In some embodiments, the migration preventing element 80 and / or the legs 84 of the migration preventing element 80 may be biased toward the open configuration using mechanical means. Other configurations are contemplated.

[0082] 5 illustrates selected embodiments of the implant delivery system 30 with the migration preventing element 80 positioned in the retracted configuration. After releasing the replacement heart valve implant 10 and / or the expandable framework 12 from the implant holder 60, the implant holder 60 can be moved toward and / or into the closed configuration before removing the implant delivery system 30 from the patient. Thus, after releasing the replacement heart valve implant 10 and / or the expandable framework 12 from the implant holder 60, the proximal sheath 62 and the distal sheath 64 can be moved axially and / or longitudinally relative to one another. After disengaging the migration preventing element 80 and / or the legs 84 of the migration preventing element 80 from the replacement heart valve implant 10, the expandable framework 12, and / or the commissure posts 17, the migration preventing element 80 and / or the legs 84 of the migration preventing element 80 can be collapsible radially inward toward the retracted configuration. As the proximal sheath 62 moves upstream and / or distally toward the distal sheath 64, the proximal sheath 62 engages with the multiple legs 84 of the migration prevention element 80, causing the multiple legs 84 to move radially inward and upstream and / or distally, resulting in at least a portion of the migration prevention element 80 extending upstream and / or distally from the attached position.

[0083] In some embodiments, the legs 84 of the migration preventing element 80 extend upstream and / or distally from the annular ring 82 of the migration preventing element 80 in the retracted configuration (e.g., FIG. 5). In some embodiments, the legs 84 of the migration preventing element 80 extend upstream and / or distally from the attachment end in the retracted configuration. In some embodiments, the free end may be located upstream and / or distally of the attachment end and / or the annular ring 82 of the migration preventing element 80 in the retracted configuration. Other configurations are contemplated.

[0084] In some embodiments, the legs 84 of the migration preventing element 80 can extend longitudinally along and / or along the outer surface of the tubular member (e.g., intermediate tubular member 56) when the migration preventing element 80 is in the retracted configuration, as shown in FIGURE 5. In some embodiments, the legs 84 of the migration preventing element 80 can extend upstream and / or distally along and / or along the outer surface of the tubular member (e.g., intermediate tubular member 56) when the migration preventing element 80 is in the retracted configuration.

[0085] A method of delivering a replacement heart valve implant 10 into a native heart valve (e.g., an aortic valve) may include advancing an implant delivery system 30 to a position adjacent to the native heart valve (e.g., an aortic valve). As described herein, the replacement heart valve implant 10 may be restrained within an implant retaining portion 60 of the implant delivery system 30, as shown in FIG. 2. A method of delivering a replacement heart valve implant 10 into a native heart valve (e.g., an aortic valve) may further include deploying the replacement heart valve implant 10 and / or the expandable framework 12 within the native heart valve (e.g., an aortic valve).

[0086] As described herein, the implant delivery system 30 may include a migration prevention element 80 configured to move between a delivery configuration and an open configuration. In some embodiments, the migration prevention element 80 may be further configured to move to a retraction configuration. The migration prevention element 80 may be configured to prevent downstream and / or proximal migration of the replacement heart valve implant 10 and / or the expandable framework 12 relative to the implant delivery system 30 and / or tubular member (e.g., intermediate tubular member 56) when the migration prevention element 80 is in the open configuration.

[0087] In some embodiments, deploying the replacement heart valve implant 10 and / or the expandable framework 12 within the native heart valve (e.g., an aortic valve) may further include moving the proximal sheath 62 and / or the implant retaining portion 60 of the implant delivery system 30 downstream and / or proximally relative to the replacement heart valve implant 10 and / or the expandable framework 12 to release a proximal portion of the replacement heart valve implant 10 and / or the expandable framework 12, thereby allowing the proximal portion of the replacement heart valve implant 10 and / or the expandable framework 12 to move toward a radially expanded configuration and the anti-migration element 80 to move toward an open configuration. In some embodiments, deploying the replacement heart valve implant 10 and / or expandable framework 12 within the native heart valve (e.g., an aortic valve) may further include subsequently moving the distal sheath 64 and / or implant retaining portion 60 of the implant delivery system 30 upstream and / or distally relative to the replacement heart valve implant 10 and / or expandable framework 12 to release a distal portion of the replacement heart valve implant 10 and / or expandable framework 12, thereby allowing the distal portion of the replacement heart valve implant 10 and / or expandable framework 12 to move toward a radially expanded configuration, as shown in FIG. 3.

[0088] In some embodiments, the method may include deploying the replacement heart valve implant 10 and / or the expandable framework 12 within the native heart valve (e.g., an aortic valve) and then retracting and / or withdrawing the implant delivery system 30 relative to the replacement heart valve implant 10 and / or the expandable framework 12. In some embodiments, retracting and / or withdrawing the implant delivery system 30 may include moving and / or translating the implant delivery system 30 downstream and / or proximally relative to the replacement heart valve implant 10 and / or the expandable framework 12. In some alternative configurations, retracting and / or withdrawing the implant delivery system 30 may include moving and / or translating the implant delivery system 30 upstream and / or distally relative to the replacement heart valve implant 10 and / or the expandable framework 12. Other configurations are contemplated.

[0089] In some embodiments, retracting and / or withdrawing the implant delivery system 30 relative to the replacement heart valve implant 10 and / or the expandable framework 12 may cause the anti-migration element 80 and / or the legs 84 of the anti-migration element 80 to disengage from the replacement heart valve implant 10, the expandable framework 12, and / or the commissure posts 17, as shown in FIG. 4 . In some embodiments, the implant delivery system 30 may be retracted and / or withdrawn relative to the replacement heart valve implant 10 and / or the expandable framework 12 by at least the length of the legs 84 of the anti-migration element 80 measured from the attachment end to the free end. In some embodiments, the implant delivery system 30 may be retracted and / or withdrawn relative to the replacement heart valve implant 10 and / or the expandable framework 12 by less than the length of the legs 84 of the anti-migration element 80 measured from the attachment end to the free end. For example, the implant delivery system 30 can be retracted and / or withdrawn relative to the replacement heart valve implant 10 and / or the expandable framework 12 to an extent sufficient to allow the migration preventing element 80 and / or the legs 84 of the migration preventing element 80 to move radially inward toward the retracted configuration, where the free end of each leg of the legs 84 of the migration preventing element 80 does not contact the replacement heart valve implant 10, the expandable framework 12, and / or the commissure posts 17 as the migration preventing element 80 and / or the legs 84 of the migration preventing element 80 move radially inward toward the retracted configuration. Other configurations are also contemplated. In FIG. 4 , the implant delivery system 30 is shown retracted and / or withdrawn an exaggerated amount relative to the replacement heart valve implant 10 and / or the expandable framework 12 to more clearly illustrate selected features of the implant delivery system 30.

[0090] In some embodiments, the method may include, after deploying the replacement heart valve implant 10 and / or the expandable framework 12 within a native heart valve (e.g., an aortic valve), moving the implant holder 60 from an open configuration to a closed configuration. For example, moving the implant holder 60 from the open configuration to the closed configuration may include moving and / or translating the proximal sheath 62 and the distal sheath 64 toward each other. In some embodiments, moving the implant holder 60 from the open configuration to the closed configuration may include moving and / or translating the proximal sheath 62 upstream and / or distally relative to the tubular member (e.g., the intermediate tubular member 56) and / or moving and / or translating the distal sheath 64 downstream and / or proximally relative to the tubular member (e.g., the intermediate tubular member 56).

[0091] In some embodiments, after disengaging the migration preventing element 80 and / or the legs 84 of the migration preventing element 80 from the replacement heart valve implant 10, the expandable framework 12, and / or the commissure posts 17, the migration preventing element 80 and / or the legs 84 of the migration preventing element 80 can contract radially inward to a retracted configuration in which the annular ring 82 of the migration preventing element 80 and / or the legs 84 of the migration preventing element 80 extend upstream and / or distally from the attachment location of the annular ring 82 of the migration preventing element 80 to the tubular member (e.g., the intermediate tubular member 56).

[0092] In some embodiments, moving the implant holding portion 60 from the open configuration to the closed configuration can include moving the migration preventing element 80 and / or the plurality of legs 84 of the migration preventing element 80 toward and / or to the retraction configuration, as shown in Figure 5. In some embodiments, moving the implant holding portion 60 from the open configuration to the closed configuration can include moving and / or retracting the migration preventing element 80 and / or the plurality of legs 84 of the migration preventing element 80 radially inward toward and / or to the retraction configuration.

[0093] In some embodiments, the method may include, after deploying the replacement heart valve implant 10 and / or the expandable framework 12 within the native heart valve (e.g., aortic valve), further retracting and / or withdrawing the implant delivery system 30 relative to the replacement heart valve implant 10 and / or the expandable framework 12. In some embodiments, the method may include, after deploying the replacement heart valve implant 10 and / or the expandable framework 12 within the native heart valve (e.g., aortic valve), further retracting and / or withdrawing the implant delivery system 30 from the treatment site, from a location adjacent to the native heart valve (e.g., aortic valve), and / or from the patient.

[0094] In at least some interventions, the replacement heart valve implant 10 may be deployed within the native heart valve (e.g., the native heart valve is left in place and not removed). Alternatively, the native heart valve may be removed (e.g., by valvuloplasty, etc.) and the replacement heart valve implant 10 may be deployed in its place as a replacement.

[0095] The various components of the replacement heart valve systems disclosed herein, and materials that can be used for the various elements thereof, may 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, components, and methods described herein, and the description may apply to other elements, members, components, or devices disclosed herein, such as, but not limited to, replacement heart valve implants, expandable frameworks, multiple valve leaflets, implant delivery systems, handles, elongate shaft assemblies, and / or elements or components thereof.

[0096] In some embodiments, the system and / or its components may be made from metals, metal alloys, polymers, metal-polymer composites, ceramics, combinations thereof, etc., or other suitable materials.

[0097] Other examples of some suitable polymers include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, e.g., DELRIN®), polyether block esters, polyurethanes, polypropylene (PP), polyvinyl chloride (PVC), polyether-esters (e.g., ARNITEL®), ether or ester based copolymers (e.g., butylene / poly(alkylene ether) phthalates and / or other polyester elastomers (such as HYTREL®), polyamides (e.g., DURETHAN®, or CRISTAMID®), elastomeric polyamides, block polyamide / ethers, polyether block amides (PEBA, e.g., PEBAX®), ethylene vinyl acetate copolymers (EVA), silicones, 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 (GRILAMID®, etc.), perfluoro(propyl vinyl ether) The polymer may include poly(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, polyurethane silicone copolymer (e.g., Elast-Eon® or ChronoSil®), ionomer, biocompatible polymer, other suitable material, or mixtures, combinations, copolymers, polymer / metal composites, etc.In some embodiments, the system and / or its components may be blended with a liquid crystal polymer (LCP). For example, the mixture may contain up to about 6% LCP.

[0098] 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®; UNS: N06022, such as HASTELLOY® C276®); UNS:N10276, other HASTELLOY® alloys, etc.), nickel-copper 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.

[0099] 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 (e.g., ultrasound, etc.) 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.

[0100] 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.

[0101] 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.

[0102] 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.

[0103] 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 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); immunosuppressants (such as the "olimus" family of drugs, rapamycin analogs, macrolide antibiotics, biolimus, everolimus, zotarolimus, temsirolimus, picrolimus, novolimus, myolimus, tacrolimus, sirolimus, pimecrolimus); cholesterol-lowering agents; vasodilators; and agents that interfere with endogenous vasoactive mechanisms.

[0104] 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. A replacement heart valve system comprising:

1. A replacement heart valve implant, comprising: an expandable framework configured to move from a radially contracted configuration to a radially expanded configuration; a plurality of valve leaflets attached to the expandable framework at a plurality of commissure posts; and an implant delivery system comprising a handle and an elongate shaft assembly, the elongate shaft assembly including a tubular member fixedly attached to the handle and an implant retainer configured to restrain the expandable framework in the radially contracted configuration; the elongate shaft assembly further includes an anti-migration element configured to move between a delivery configuration and an open configuration; The replacement heart valve system, wherein the anti-migration element is configured to prevent proximal movement of the expandable framework relative to the tubular member in the open configuration.

2. The replacement heart valve system of claim 1 , wherein the anti-migration element is engaged with the plurality of commissure posts.

3. 3. The replacement heart valve system of claim 1, wherein the anti-migration element extends radially outward from the tubular member in the open configuration.

4. 4. The replacement heart valve system of claim 3, wherein the anti-migration element includes an annular ring and a plurality of legs extending radially outward from the annular ring, the plurality of legs being engaged with the plurality of commissure posts.

5. 5. The replacement heart valve system of claim 4, wherein the annular ring is fixedly attached to the tubular member.

6. 6. The replacement heart valve system of claim 4, wherein each leg of the plurality of legs extends radially outward of the plurality of commissure posts.

7. 7. The replacement heart valve system of claim 4, wherein the annular ring is positioned distal to a proximal-most portion of the plurality of legs when the anti-migration element is engaged with the plurality of commissure posts.

8. 8. The replacement heart valve system of claim 4, wherein the plurality of legs extend longitudinally along the tubular member when the expandable framework is in the radially contracted configuration.

9. The replacement heart valve system of any one of claims 1 to 8, wherein the anti-migration element is biased toward the open configuration.

10. The replacement heart valve system of any one of claims 1 to 9, wherein a portion of the anti-migration element abuts the plurality of commissure posts.

11. The replacement heart valve system of any one of claims 1 to 10, wherein the anti-migration element is not attached to the plurality of commissure posts.

12. 12. The replacement heart valve system of claim 1, wherein the implant delivery system includes a stent holder fixedly attached to the tubular member, the stent holder configured to engage a distal portion of the expandable framework when the expandable framework is constrained within the implant retaining portion.

13. 13. The replacement heart valve system of claim 12, wherein the anti-migration element is positioned proximally relative to the stent holder.

14. 1. A method for delivering a replacement heart valve implant to a native heart valve, comprising: advancing an implant delivery system to a position adjacent the native heart valve, wherein the replacement heart valve implant is constrained within an implant retention portion of the implant delivery system; deploying the replacement heart valve implant within the native heart valve; the replacement heart valve implant includes an expandable framework configured to move from a radially contracted configuration to a radially expanded configuration, and a plurality of valve leaflets attached to the expandable framework at a plurality of commissure posts; the implant delivery system includes an anti-migration element configured to move between a delivery configuration and an open configuration; The method, wherein the anti-migration element is configured to prevent proximal migration of the expandable framework relative to the implant delivery system when the anti-migration element is in the open configuration.

15. Deploying the replacement heart valve implant includes: moving a proximal sheath of the implant delivery system proximally relative to the replacement heart valve implant to release a proximal portion of the expandable framework, thereby allowing the proximal portion of the expandable framework to move toward the radially expanded configuration and the anti-migration element to move toward the open configuration; and then moving a distal sheath of the implant delivery system distally relative to the replacement heart valve implant to release a distal portion of the expandable framework, thereby allowing the distal portion of the expandable framework to move toward the radially expanded configuration.

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