Heart valve attachment mechanism

Abstract

The replacement heart valve implant includes an expandable framework configured to transition between a radially collapsed configuration and a radially expanded configuration, and a plurality of valve leaflets secured to the framework. The framework includes a tubular wall defining an inflow end and an outflow end. The inflow end includes a mounting tab extending radially inward from the tubular wall. The replacement heart valve system includes the above-described implant and a delivery system including a shaft assembly extending distally from a handle. A method of loading the implant includes placing the implant in the collapsed configuration adjacent an implant-holding portion of the delivery system, positioning a distal sheath of the delivery system at least partially over a groove formed in an outer surface of a stent holder of the delivery system, inserting the mounting tab into the groove, and rotating the implant relative to the delivery system.

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. Specifically, the disclosure relates to features for coupling a replacement heart valve implant to an implant delivery device. This application claims the benefit of priority to U.S. Provisional Application No. 63 / 427,669, filed November 23, 2022, the entire disclosure of which is incorporated herein by reference. [Background technology]

[0002] A wide variety of intracorporeal medical devices have been developed for medical applications, such as surgical and / or intravascular applications. Some of these devices include guidewires (e.g., for stents, grafts, replacement valves, etc.), catheters, medical device systems, etc. 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 remains a 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 implant can include an expandable framework configured to transition between a radially collapsed configuration and a radially expanded configuration, and a plurality of valve leaflets secured to the expandable framework. The expandable framework can include a tubular wall defining an inflow end and an outflow end. The inflow end can include an attachment tab extending radially inward from the tubular wall.

[0004] Additionally or alternatively to any embodiment described herein, the attachment tabs extend radially inward from the tubular wall between about 1.5 millimeters and about 3.5 millimeters.

[0005] Additionally or alternatively to any embodiment described herein, the attachment tabs extend radially inward from the tubular wall between about 2.0 millimeters and about 3.0 millimeters.

[0006] Additionally or alternatively to any embodiment described herein, the attachment tabs are axially spaced apart from the plurality of leaflets. Additionally or alternatively to any embodiment described herein, the outflow end includes a plurality of stabilizing arches extending axially away from the plurality of leaflets.

[0007] Additionally or alternatively to any of the embodiments described herein, the replacement heart valve implant may include a sealing member disposed on the expandable framework proximate the inflow end.

[0008] Additionally or alternatively to any of the embodiments described herein, a replacement heart valve system may include a replacement heart valve implant and an implant delivery system. The replacement heart valve implant includes an expandable framework configured to transition between a radially collapsed configuration and a radially expanded configuration, and a plurality of valve leaflets secured to the expandable framework. The expandable framework includes a tubular wall defining an inflow end and an outflow end, the inflow end including a mounting tab extending radially inward from the tubular wall. The implant delivery system includes a handle and an elongate shaft assembly extending distally from the handle. A distal portion of the elongate shaft assembly includes an implant retention portion configured to engage the replacement heart valve implant in the radially collapsed configuration.

[0009] Additionally or alternatively to any of the embodiments described herein, the elongate shaft assembly includes an outer tubular member extending distally from the handle and an inner shaft extending distally from the handle within the outer tubular member to a distal tip distal to the implant holding portion.

[0010] Additionally or alternatively to any of the embodiments described herein, the implant holding portion may include a proximal sheath configured to cover a proximal portion of the replacement heart valve implant in the radially folded configuration, and a distal sheath configured to cover a distal portion of the replacement heart valve implant in the radially folded configuration.

[0011] Additionally or alternatively to any embodiment described herein, a distal portion of the replacement heart valve implant includes the inflow end. Additionally or alternatively to any embodiment described herein, the implant holding portion includes a stent holder having a groove formed in an outer surface of the stent holder, the groove configured to receive the mounting tab.

[0012] Additionally or alternatively to any embodiment described herein, the implant holding portion includes an atraumatic transition shield disposed proximally of the stent holder, the atraumatic transition shield including slots aligned with the grooves of the stent holder.

[0013] Additionally or alternatively to any embodiment described herein, the groove is formed as an L-shaped slot having a first portion extending axially and a second portion extending circumferentially from the first portion.

[0014] Additionally or alternatively to any embodiment described herein, the second portion of the L-shaped slot is axially spaced from a proximal end of the first portion of the L-shaped slot.

[0015] Additionally or alternatively to any of the embodiments described herein, a method of loading a replacement heart valve implant into a replacement heart valve system may include positioning the replacement heart valve implant adjacent an implant holding portion of an implant delivery system, the replacement heart valve implant having an expandable framework structure positioned in a radially collapsed configuration; positioning a distal sheath of the implant delivery system at least partially over a groove formed in an outer surface of a stent holder of the implant delivery system; inserting a mounting tab provided proximate an inflow end of the expandable framework into the groove; and rotating the replacement heart valve implant relative to the implant delivery system.

[0016] Additionally or alternatively to any embodiment described herein, the groove is formed as an L-shaped slot having a first portion extending axially and a second portion extending circumferentially from the first portion.

[0017] Additionally or alternatively to any embodiment described herein, rotating the replacement heart valve implant includes translating the mounting tabs into the second portion of the L-shaped slot.

[0018] Additionally or alternatively to any of the embodiments described herein, the method may include translating a proximal sheath of the implant delivery system distally over a proximal portion of a replacement heart valve implant.

[0019] Additionally or alternatively to any embodiment described herein, inserting attachment tabs into grooves includes axially translating the replacement heart valve implant relative to the implant delivery system.

[0020] Additionally or alternatively to any embodiment described herein, the attachment tabs are monolithically formed with the expandable framework. 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 figures and the detailed description that follow more particularly exemplify these embodiments. [Brief explanation of the drawings]

[0021] [Figure 1] FIG. 1 illustrates selected embodiments of a replacement heart valve implant. [Figure 2] FIG. 2 illustrates selected aspects of an expandable framework associated with the replacement heart valve implant of FIG. [Figure 3] FIG. 3 illustrates selected embodiments of an implant delivery system that can be used with the replacement heart valve implant of FIG. [Figure 4-8] 4-8 illustrate selected aspects of using the implant delivery system of FIG. 3 with the replacement heart valve implant of FIG. DETAILED DESCRIPTION OF THE INVENTION

[0022] The present disclosure can be more fully understood in consideration of the following detailed description of various embodiments in conjunction with the drawings, in which: While the present disclosure is susceptible to various modifications and alternative forms, specific forms thereof have been shown by way of example in the drawings and are described in detail below. However, the aspects of the present disclosure are not intended to be limited to the particular embodiments described. Rather, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present disclosure.

[0023] The following detailed description should be read with reference to the drawings, which are not necessarily to scale and in which similar elements in different drawings are numbered the same. The detailed description and drawings are illustrative of the disclosure and are not intended to 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 illustrate exemplary embodiments of the disclosure.

[0024] For the following defined terms, these definitions shall be applied, unless a different definition is given in the claims or elsewhere in this specification. All numerical values, whether explicitly stated herein or not, are assumed to be modified by the term "about." The term "about" refers to a range of numerical values ​​that one of ordinary skill in the art would generally consider equivalent to the recited value (e.g., having the same function or result). In many cases, the term "about" may include numbers that are rounded to the nearest significant figure. Other uses of the term "about" (e.g., in contexts other than numerical values) may be assumed to have one or more of their ordinary and accustomed definitions that are understood from and consistent with the context of this specification, unless otherwise specified.

[0025] 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 certain preferred dimensions, ranges, and / or values ​​for various components, features, and / or specifications are disclosed, those skilled in the art, having access to this disclosure, will understand that the desired dimensions, ranges, and / or values ​​may deviate from those expressly disclosed.

[0026] As used in this specification and claims, the term "a" includes plural referents unless the context clearly dictates otherwise. As used in this specification and claims, the term "or" generally includes "and / or" unless the context clearly dictates otherwise. For ease of understanding, some features of the present disclosure may be described in the singular, even though those features may be multiple or repeated within one or more disclosed embodiments. Each instance of a plurality of features may include and / or be encompassed by the singular disclosure unless expressly stated to the contrary. For example, a reference to a feature may also refer to two or more instances and quantities of that feature unless expressly stated to the contrary. Thus, the following description may apply equally to any and / or all of two or more instances of a component present in a device, unless expressly stated to the contrary.

[0027] Relative terms such as “proximal,” “distal,” “advancing,” “retracting,” and variations thereof may generally be considered with respect to the positioning, orientation, and / or movement of various elements relative to a user / operator / pilot 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 instances, the terms “proximal” and “distal” may be assigned arbitrarily to facilitate understanding of the present disclosure, and such instances may be readily apparent to one of ordinary skill in the art. Other relative terms such as “upstream,” “downstream,” “inflow,” and “outflow” refer to the direction of fluid flow within a lumen, such as a body lumen, blood vessel, or 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.

[0028] The term "extent" may be understood to mean the maximum measurement of a stated or specified dimension, unless the range or dimension in question is preceded by or specified as "minimum," where "minimum" may be understood to mean the smallest measurement of a stated or specified dimension. For example, an "outer extent" may be understood to mean the largest outer dimension, a "radial extent" may be understood to mean the largest radial dimension, and a "longitudinal extent" may be understood to mean the largest longitudinal dimension. Instances of "extent" may vary (e.g., axial, longitudinal, lateral, radial, circumferential, etc.) and may be apparent to one of ordinary skill in the art from the context of a particular use. Generally, an "extent" may be considered the largest possible dimension measured according to the intended use, and a "minimum extent" may be considered the smallest possible dimension measured according to the intended use. In some instances, "extent" may generally be measured perpendicularly in a plane and / or cross-section, but may also be measured variously, including but not limited to, at an angle, radially, circumferentially (e.g., along an arc), etc., as may become apparent from the particular context.

[0029] The terms "monolithic" and "unitary" generally refer to one or more elements made up of or consisting of a single structure or base unit / element. Monolithic and / or unitary elements are intended to exclude structures and / or features made by assembling or joining together multiple separate elements.

[0030] References herein to "an embodiment," "some embodiments," "other embodiments," etc., mean that the described embodiment may include a particular feature, structure, or characteristic, but not all embodiments necessarily include that particular feature, structure, or characteristic. Furthermore, such phrases do not necessarily refer to the same embodiment. Furthermore, when a particular feature, structure, or characteristic is described in connection with one embodiment, those skilled in the art will recognize that such particular feature, structure, or characteristic also applies to other embodiments, unless expressly stated to the contrary, whether or not explicitly described. That is, it is intended that the 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 would be understood by those skilled in the art.

[0031] For purposes of clarity, certain numerical terms (e.g., first, second, third, fourth, etc.) may be used throughout the specification and / or claims to name and / or distinguish between various features described and / or claimed. This numerical terminology is not intended to be limiting, but is merely exemplary. In some embodiments, variations and departures from previously used numerical terminology 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 designation in each instance will be apparent to one of ordinary skill in the art.

[0032] Also, for clarity and / or brevity, some features may not be shown or may be shown only diagrammatically in any given figure. Additional details regarding some components and / or method steps may be shown in more detail in other figures. The apparatus and / or methods disclosed herein may provide several desirable features and advantages, as described in more detail below.

[0033] 1 illustrates selected embodiments of a replacement heart valve implant 10. It should be noted that the replacement heart valve implant 10 may be any type of replacement heart valve (e.g., mitral valve, aortic valve, etc.). In use, the replacement heart valve implant 10 may be implanted (e.g., surgically or via transcatheter delivery) into the heart of a mammal. The replacement heart valve implant 10 may be configured to allow unidirectional flow through the replacement heart valve implant 10 from the inflow end to the outflow end.

[0034] The replacement heart valve implant 10 may include an expandable framework 12 defining 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, oval, etc.). Some suitable, non-limiting examples of materials that may be used to form the expandable framework 12 are described below, including metals and metal alloys, composites, ceramics, polymers, etc. The expandable framework 12 may be configured to transition between a radially collapsed configuration and a radially expanded configuration. In some embodiments, the expandable framework 12 may be self-expanding. In some embodiments, the expandable framework 12 may be self-biased toward the radially expanded configuration. In some embodiments, the expandable framework 12 may be mechanically expandable. In some embodiments, the expandable framework 12 may be balloon-expandable. Other configurations are also contemplated. In some embodiments, the expandable framework 12 can include and / or define a plurality of apertures (eg, openings) therethrough.

[0035] In some embodiments, the expandable framework 12 can define a lower apex 14 proximate the inflow end, an upper apex 16 proximate the outflow end, and a plurality of stabilizing arches 18 extending downstream from the outflow end. In some embodiments, the lower apex 14 can be located at the inflow end. In some embodiments, the upper apex 16 can be located at the outflow end. In some embodiments, the expandable framework 12 can include a tubular wall defining a central lumen, an inflow end, an outflow end, the lower apex 14, and / or the upper apex 16. In some embodiments, the plurality of stabilizing arches 18 can extend downstream of and / or away from the upper apex 16 in a direction opposite the lower apex 14. In some embodiments, the upper apex 16 can be located longitudinally and / or axially between the lower apex 14 and the plurality of stabilizing arches 18.

[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 be relative to the implant delivery device and / or relative to the direction of implantation relative to the 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 an upper apex 16 and / or multiple leaflets 20. In some embodiments, the distal portion may include an inflow end and / or lower apex 14. Other configurations are also contemplated.

[0037] In some embodiments, the replacement heart valve implant 10 can include a plurality of leaflets 20 disposed within a central lumen. The leaflets 20 can be coupled, fixed, and / or fixedly attached to the expandable framework 12. In some embodiments, the outflow end of the expandable framework 12 can include a plurality of stabilizing arches 18 that extend axially away from the leaflets 20 and / or that extend axially away from one or more joints or attachment points between the leaflets 20 and the expandable framework 12.

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

[0039] The leaflets 20 can 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 ends of the leaflets 20 can move together in the closed position to substantially restrict fluid flow through the replacement heart valve implant 10. The free ends of the leaflets 20 can move apart in the open position to allow fluid flow through the replacement heart valve implant 10. In FIG. 1 , the leaflets 20 are shown in an open or partially open position (e.g., a neutral position) to which the leaflets 20 can move when not biased by fluid flow.

[0040] In some embodiments, the plurality of leaflets 20 may be composed of a polymer (e.g., a thermoplastic polymer). In some embodiments, the plurality of leaflets 20 may comprise at least 50 weight percent polymer. In some embodiments, the plurality of 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 can include an inner skirt 22 disposed on and / or extending along an inner surface of the expandable framework 12. In at least some embodiments, the inner skirt 22 can be fixedly attached to the expandable framework 12. The inner skirt 22 can 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 can be fixedly attached to and / or integrally formed with the plurality of valve leaflets 20. The inner skirt 22 can ensure that fluid flows through a central lumen of the replacement heart valve implant 10, preventing fluid from flowing around the plurality of valve leaflets 20 when the plurality of valve leaflets 20 are in a 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 apexes 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 flow through the replacement heart valve implant 10 and do not flow around the replacement heart valve implant 10, thereby preventing fluid flow when the plurality of valve leaflets 20 are in the 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 a 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 a polymer. In some embodiments, one or more of the 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. In some embodiments, the inner skirt 22 and / or the outer skirt 24 can be substantially impermeable to fluids. In some embodiments, the inner skirt 22 and / or the outer skirt 24 can be formed from thin tissue (e.g., bovine pericardium, etc.). In some embodiments, the inner skirt 22 and / or the outer skirt 24 can be formed from a coated textile material. In some embodiments, the inner skirt 22 and / or the outer skirt 24 can be formed from a non-porous and / or impermeable textile material. Other configurations are contemplated. Some suitable, non-limiting examples of materials that may be used to form the inner skirt 22 and / or outer skirt 24 are described below, including, but not limited to, polymers, composites, and the like.

[0044] In some embodiments, the inner skirt 22 and / or the outer skirt 24 may seal one, some, a plurality, or each of a plurality of gaps formed in the expandable framework 12. In at least some embodiments, sealing a gap may be considered to prevent fluid from flowing through the gap 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, tying with sutures or filaments, adhesive bonding, fusion bonding, embedding or overmolding, welding, etc.

[0045] In some embodiments, the replacement heart valve implant 10 can include a sealing member disposed on the expandable framework 12 proximate the inflow end. In some embodiments, the sealing member can include and / or can be an inner skirt 22. In some embodiments, the sealing member can include and / or can be an outer skirt 24. In some embodiments, the sealing member can include and / or can be an inner skirt 22 and an outer skirt 24. Other configurations are also contemplated.

[0046] In some embodiments, the expandable framework 12 and / or replacement heart valve implant 10 can have an outer extent in an unconstrained configuration (e.g., in 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 outer extent in a radially collapsed configuration of about 10 mm, about 9 mm, about 8 mm, about 7 mm, about 6 mm, etc. Other configurations are also contemplated.

[0047] 2 illustrates selected aspects of the expandable framework 12, with other elements of the replacement heart valve implant 10 removed for clarity. In at least some embodiments, the inflow end and / or lower apex 14 can include attachment tabs 15 extending radially inward from the expandable framework 12 and / or the tubular wall. In some embodiments, the attachment tabs 15 can be formed and / or provided at the axial tip of the expandable framework 12. In some embodiments, the attachment tabs 15 can be provided within a distal portion of the replacement heart valve implant 10. In some embodiments, the attachment tabs 15 can be provided at the distal-most end of the expandable framework 12.

[0048] In some embodiments, the attachment tabs 15 may be monolithically and / or integrally formed with the expandable framework 12. In some embodiments, the attachment tabs 15 may be axially spaced apart from the plurality of valve leaflets 20. In some embodiments, the attachment tabs 15 may extend radially inward from the expandable framework 12 and / or tubular wall between about 1.5 millimeters and about 3.5 millimeters. In some embodiments, the attachment tabs 15 may extend radially inward from the expandable framework 12 and / or tubular wall between about 2.0 millimeters and about 3.0 millimeters. In some embodiments, the attachment tabs 15 may extend radially inward from the expandable framework 12 and / or tubular wall between about 2.25 millimeters and about 2.75 millimeters. In some embodiments, the mounting tabs 15 may extend radially inward from the expandable framework 12 and / or tubular wall about 2.0 millimeters, about 2.1 millimeters, about 2.2 millimeters, about 2.3 millimeters, about 2.4 millimeters, about 2.5 millimeters, about 2.6 millimeters, about 2.7 millimeters, about 2.8 millimeters, or another suitable distance. Other configurations are also contemplated.

[0049] In some embodiments, the inflow end and / or lower apex 14 can include multiple attachment tabs extending radially inward from the expandable framework 12 and / or tubular wall. In some embodiments, the multiple attachment tabs can be spaced apart around the circumference of the expandable framework 12 and / or tubular wall. In some embodiments, the multiple attachment tabs can be spaced apart equidistantly around the circumference of the expandable framework 12 and / or tubular wall.

[0050] In some embodiments, at least one of the plurality of mounting tabs may be formed and / or disposed at an axial tip of the expandable framework 12. In some embodiments, at least one of the plurality of mounting tabs may be provided within a distal portion of the replacement heart valve implant 10. In some embodiments, at least one of the plurality of mounting tabs may be provided at a distal-most end of the expandable framework 12. In some embodiments, at least one of the plurality of mounting tabs may be monolithically and / or integrally formed with the expandable framework 12. In some embodiments, at least one of the plurality of mounting tabs may be axially spaced apart from the plurality of valve leaflets 20. In some embodiments, at least one of the plurality of mounting tabs may extend radially inward from the expandable framework 12 and / or the tubular wall between about 1.5 millimeters and about 3.5 millimeters. In some embodiments, at least one of the plurality of mounting tabs may extend radially inward from the expandable framework 12 and / or the tubular wall between about 2.0 millimeters and about 3.0 millimeters. In some embodiments, at least one of the plurality of mounting tabs can extend radially inward from the expandable framework 12 and / or the tubular wall between about 2.25 millimeters and about 2.75 millimeters. In some embodiments, at least one of the plurality of mounting tabs can extend radially inward from the expandable framework 12 and / or the tubular wall about 2.0 millimeters, about 2.1 millimeters, about 2.2 millimeters, about 2.3 millimeters, about 2.4 millimeters, about 2.5 millimeters, about 2.6 millimeters, about 2.7 millimeters, about 2.8 millimeters, or another suitable distance. Other configurations are also contemplated.

[0051] In some embodiments, each mounting tab of the plurality of mounting tabs may be formed and / or provided at an axial tip of the expandable framework 12. In some embodiments, each mounting tab of the plurality of mounting tabs may be provided within a distal portion of the replacement heart valve implant 10. In some embodiments, each mounting tab of the plurality of mounting tabs may be located at the distal-most end of the expandable framework 12. In some embodiments, each mounting tab of the plurality of mounting tabs may be monolithically and / or integrally formed with the expandable framework 12. In some embodiments, each mounting tab of the plurality of mounting tabs may be axially spaced apart from the plurality of valve leaflets 20. In some embodiments, each mounting tab of the plurality of mounting tabs may extend radially inward from the expandable framework 12 and / or the tubular wall between about 1.5 millimeters and about 3.5 millimeters. In some embodiments, each mounting tab of the plurality of mounting tabs may extend radially inward from the expandable framework 12 and / or the tubular wall between about 2.0 millimeters and about 3.0 millimeters. In some embodiments, each mounting tab of the plurality of mounting tabs can extend radially inward from the expandable framework 12 and / or tubular wall between about 2.25 millimeters and about 2.75 millimeters. In some embodiments, each mounting tab of the plurality of mounting tabs can extend radially inward from the expandable framework 12 and / or tubular wall about 2.0 millimeters, about 2.1 millimeters, about 2.2 millimeters, about 2.3 millimeters, about 2.4 millimeters, about 2.5 millimeters, about 2.6 millimeters, about 2.7 millimeters, about 2.8 millimeters, or another suitable distance. Other configurations are also contemplated.

[0052] 3 illustrates selected embodiments of a replacement heart valve system including an implant delivery system 30 that is compatible with and / or usable with the replacement heart valve implant 10. Note that at least one scale has been altered in FIG. 3 (e.g., not all parts of the figure are drawn to scale) for clarity of illustration and to show additional details of selected embodiments of the implant delivery system 30. Also, some elements of the replacement heart valve implant 10 are not shown for clarity of illustration.

[0053] 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 46 and a second rotatable knob 48. In at least some embodiments, the first rotatable knob 46 and / or the second rotatable knob 48 may be configured to rotate about a central longitudinal axis of the implant delivery system 30 and / or the handle 40.

[0054] In some embodiments, the distal portion of the implant delivery system 30 and / or the elongate shaft assembly 50 may include an implant retaining portion configured to engage and / or retain the replacement heart valve implant 10 and / or the expandable framework 12 in a radially collapsed configuration. The elongate shaft assembly 50 may include an outer tubular member 56 extending distally from the handle 40 and an inner shaft 60 extending distally from the handle 40 within the outer tubular member 56 to a distal tip 58 disposed distally of the implant retaining portion. In some embodiments, the implant retaining portion may include a proximal sheath 52 and a distal sheath 54. In some embodiments, the inner shaft 60 may be slidably disposed within the lumen of the outer tubular member 56. In some embodiments, the inner shaft 60 may be fixedly attached to the distal sheath 54 and / or the distal tip 58. In some embodiments, the distal sheath 54 may be fixedly attached to the distal tip 58. In some embodiments, the distal sheath 54 can extend proximally from the distal tip 58. In some embodiments, the inner shaft 60 can include and / or at least partially define a guidewire lumen extending therethrough. In some embodiments, the guidewire lumen can extend through the handle 40.

[0055] In some embodiments, the handle 40 can be configured to manipulate and / or translate the proximal sheath 52 and / or the distal sheath 54 relative to one another. In some embodiments, the first rotatable knob 46 and / or the second rotatable knob 48 can be configured to manipulate and / or axially translate the proximal sheath 52 and / or the distal sheath 54 relative to one another. In some embodiments, the handle 40 can be configured to manipulate and / or translate the inner shaft 60 relative to the elongate shaft assembly 50 and / or the proximal sheath 52. In some embodiments, the first rotatable knob 46 and / or the second rotatable knob 48 can be configured to manipulate and / or axially translate the inner shaft 60 relative to the outer tubular member 56 and / or the proximal sheath 52.

[0056] During delivery of the replacement heart valve implant 10 to a treatment site, the replacement heart valve implant 10 may be at least partially disposed within the proximal sheath 52 and / or the distal sheath 54 in a radially collapsed configuration. In some embodiments, the proximal sheath 52 and / or the distal sheath 54 may collectively define an implant retaining portion of the implant delivery system 30. In some embodiments, the implant retaining portion may be configured to restrain the replacement heart valve implant 10 in the radially collapsed configuration. In some embodiments, the replacement heart valve implant 10 may be removably coupled to the inner shaft 60.

[0057] In some embodiments, the proximal sheath 52 can be configured to cover a proximal portion of the replacement heart valve implant 10 in the radially collapsed configuration. As described herein, the proximal portion of the replacement heart valve implant 10 can include the inflow end and / or the attachment tabs 15. In some embodiments, the distal sheath 54 can be configured to cover a distal portion of the replacement heart valve implant 10 in the radially collapsed configuration.

[0058] In some embodiments, the implant holding portion can include a stent holder 70 (e.g., FIGS. 4-7). In at least some embodiments, the stent holder 70 can be fixedly attached to the elongate shaft assembly 50 or a component thereof. In some embodiments, the stent holder 70 can have a generally bulbous shape. In some embodiments, the stent holder 70 can include a groove 72 formed in an outer surface of the stent holder 70. The groove 72 can be configured to receive the mounting tab 15 therein. In some embodiments, the groove 72 can be configured to slidably receive the mounting tab 15 therein.

[0059] In some embodiments, groove 72 may be formed as an L-shaped slot having a first portion 74 and a second portion 76. First portion 74 extends axially and / or generally parallel to the central longitudinal axis of elongate shaft assembly 50, and second portion 76 extends circumferentially about the central longitudinal axis of elongate shaft assembly 50 and / or circumferentially from first portion 74 of the L-shaped slot.

[0060] In some embodiments, the radially outermost portion of the stent holder 70 may be located proximate the distal end of the stent holder 70. In some embodiments, the stent holder 70 may taper radially inward in a proximal direction from the radially outermost portion of the stent holder 70. In some embodiments, the first portion 74 of the L-shaped slot may extend distally from the proximal face of the stent holder 70. In some embodiments, the first portion 74 of the L-shaped slot may extend distally from the proximal-facing, radially inward tapered surface of the stent holder 70. The second portion 76 of the L-shaped slot may be axially spaced from the proximal face of the stent holder 70 and / or from the proximal end of the first portion 74 of the L-shaped slot.

[0061] In some embodiments, the implant retaining portion can include an atraumatic transition shield 80 (e.g., FIGS. 4-7). The atraumatic transition shield 80 can be disposed adjacent to the stent holder 70. In some embodiments, the atraumatic transition shield 80 can be disposed between the stent holder 70 and the handle 40. In some embodiments, the atraumatic transition shield 80 can be disposed proximally of the stent holder 70. In some embodiments, the atraumatic transition shield 80 can be disposed at and / or adjacent to the proximal end of the stent holder 70. In some embodiments, the atraumatic transition shield 80 can axially overlap a portion of the stent holder 70. In some embodiments, the atraumatic transition shield 80 can be disposed radially outward of at least a portion of the stent holder 70. In some embodiments, the atraumatic transition shield 80 can taper proximally and / or radially inward toward the handle 40. The atraumatic transition shield 80 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.

[0062] In some embodiments, the atraumatic transition shield 80 can include a slot 82 aligned with the groove 72 of the stent holder 70. In some embodiments, the slot 82 can be axially aligned with the groove 72 of the stent holder 70. In some embodiments, the slot 82 can be circumferentially aligned with the groove 72 of the stent holder 70. In some embodiments, the atraumatic transition shield 80 can include a deflectable end disposed proximate to the stent holder 70. In some embodiments, the distal end of the atraumatic transition shield 80 can be resiliently deflectable and / or resiliently deflectable when subjected to a radially inward force. When and / or after the radially inward force is removed, the atraumatic transition shield 80 can return to its original shape. In some embodiments, the slot 82 can provide a tactile interface and / or tactile response when the mounting tabs 15 of the expandable framework 12 are inserted into the grooves 72 of the stent holder 70.

[0063] In at least some embodiments, the stent holder 70 and / or the atraumatic transition shield 80 may be axially fixed relative to the handle 40. The elongate shaft assembly 50 and / or the inner shaft 60 of the implant delivery system 30 may be slidably disposed within and / or through the stent holder 70 and / or the atraumatic transition shield 80. That is, the inner shaft 60 may be slidable relative to the stent holder 70 and / or the atraumatic transition shield 80. In some embodiments, the elongate shaft assembly 50 may include at least one tubular member disposed between the inner shaft 60 and the outer tubular member 56 (e.g., covering the inner shaft 60 within the outer tubular member 56). In some embodiments, the at least one tubular member may include multiple layers secured to one another. In some embodiments, the at least one tubular member may be multiple tubular members that are movable relative to one another (e.g., axially, rotationally, etc.). In at least some embodiments, the inner shaft 60 may extend through and / or be axially slidable relative to at least one tubular member. In some embodiments, the stent holder 70 and / or the atraumatic transition shield 80 may be fixed to and / or fixedly attached to at least one tubular member of the elongate shaft assembly 50 through which the inner shaft 60 extends and / or passes. Other configurations are also contemplated.

[0064] As described herein, in some embodiments, the inflow end and / or lower apex 14 may include a plurality of attachment tabs extending radially inward from the expandable framework 12 and / or tubular wall. Similarly, in some embodiments, the stent holder 70 may include a plurality of grooves, and the atraumatic transition shield 80 may include a plurality of slots aligned with the plurality of grooves of the stent holder 70. The plurality of grooves may be configured to receive the plurality of attachment tabs therein.

[0065] In some embodiments, the stent holder 70 can include a same number of grooves formed therein as there are attachment tabs included on the replacement heart valve implant 10 and / or the expandable framework 12. In some embodiments, the stent holder 70 can include more grooves formed therein than there are attachment tabs included on the replacement heart valve implant 10 and / or the expandable framework 12. In some embodiments, the atraumatic transition shield 80 can include a greater number of slots formed therein than there are grooves included on the stent holder 70. In some embodiments, the atraumatic transition shield 80 can include a same number of slots formed therein as there are grooves included on the stent holder 70. Other configurations are also contemplated.

[0066] The configuration and / or arrangement shown in Figure 3 may be achieved according to a method for loading a replacement heart valve implant 10 into a replacement heart valve system and / or implant delivery system 30, some details of which are further illustrated in Figures 4-7.

[0067] A method of loading the replacement heart valve implant 10 into the replacement heart valve system and / or implant delivery system 30 may include positioning the replacement heart valve implant 10 adjacent to an implant-retaining portion of the implant delivery system 30. As seen in FIG. 3 , the replacement heart valve implant 10 and / or the expandable framework 12 may be positioned in a radially collapsed configuration.

[0068] In at least some embodiments, the method may include positioning the distal sheath 54 of the implant delivery system 30 at least partially over a groove 72 formed in an outer surface of a stent holder 70 of the implant delivery system 30, as seen in FIG. 4. For clarity, the distal sheath 54 is shown in phantom to illustrate the presence of the distal sheath 54 while drawing attention to the other components. Thus, radial insertion and / or engagement of the mounting tabs 15 into the groove 72 and / or stent holder 70 may be avoided and / or prevented by the distal sheath 54.

[0069] 5 , the method may include inserting the expandable framework 12 and / or mounting tabs 15 provided proximate the inflow end of the replacement heart valve implant 10 into grooves 72 formed in the outer surface of the stent holder 70. In some embodiments, inserting the mounting tabs 15 into grooves 72 formed in the outer surface of the stent holder 70 may include axially translating the replacement heart valve implant 10, the expandable framework 12, and / or the mounting tabs 15 relative to the implant delivery system 30 and / or the stent holder 70. In some embodiments, inserting the mounting tabs 15 into grooves 72 formed in the outer surface of the stent holder 70 may include inserting and / or translating the expandable framework 12 and / or mounting tabs 15 inside and / or within the distal sheath 54. In some embodiments, inserting the mounting tabs 15 into the grooves 72 formed in the outer surface of the stent holder 70 can include inserting and / or translating the expandable framework 12 and / or the mounting tabs 15 into and / or within the distal sheath 54 without moving the distal sheath 54 relative to the stent holder 70. In some embodiments, inserting the mounting tabs 15 into the grooves 72 formed in the outer surface of the stent holder 70 can include inserting and / or translating the expandable framework 12 and / or the mounting tabs 15 into and / or within the distal sheath 54 while holding the distal sheath 54 in a fixed position relative to the stent holder 70.

[0070] In some embodiments, inserting the mounting tabs 15 into the grooves 72 formed in the outer surface of the stent holder 70 can include inserting and / or translating the expandable framework 12 and / or the mounting tabs 15 through slots 82 formed in the atraumatic transition shield 80. In some embodiments, inserting the mounting tabs 15 into the grooves 72 formed in the outer surface of the stent holder 70 can include inserting and / or translating the expandable framework 12 and / or the mounting tabs 15 through slots 82 formed in the atraumatic transition shield 80 before and / or during insertion of the mounting tabs 15 into the grooves 72 formed in the outer surface of the stent holder 70.

[0071] In some embodiments, the method may include rotating the replacement heart valve implant 10, expandable framework 12, and / or mounting tabs 15 relative to the implant delivery system 30 and / or stent holder 70. In some embodiments, rotating the replacement heart valve implant 10, expandable framework 12, and / or mounting tabs 15 relative to the implant delivery system 30 and / or stent holder 70 may include translating the mounting tabs 15 into the second portion 76 of the L-shaped slot, as seen in Figure 6. Figure 7 is a partial cross-sectional view illustrating selected aspects of the configuration and / or related arrangements shown in Figure 6.

[0072] After rotating the replacement heart valve implant 10, the expandable framework 12, and / or the mounting tabs 15 relative to the implant delivery system 30 and / or the stent holder 70, the inflow end of the replacement heart valve implant 10 and / or the expandable framework 12 may be prevented from disengaging from the stent holder 70. For example, the distal sheath 54 may substantially prevent radial expansion of the inflow end of the replacement heart valve implant 10 and / or the expandable framework 12. In another example, interference between the mounting tabs 15 and the grooves 72 of the stent holder 70 may substantially prevent axial movement of the replacement heart valve implant 10 and / or the expandable framework 12 relative to the stent holder 70 and / or the implant delivery system 30.

[0073] In some embodiments, the method may include translating the proximal sheath 52 of the implant delivery system 30 over the proximal portion of the replacement heart valve implant 10, as seen in Figure 8. In some embodiments, the method may include translating the proximal sheath 52 of the implant delivery system 30 distally over the proximal portion of the replacement heart valve implant 10. In some embodiments, the method may include translating the proximal sheath 52 of the implant delivery system 30 distally relative to the inner shaft 60 and / or the stent holder 70.

[0074] In some embodiments, the replacement heart valve implant 10 and / or the expandable framework 12 can be held in a radially collapsed configuration by the proximal sheath 52 and the distal sheath 54 in the delivery configuration of the implant delivery system 30. In some embodiments, the proximal sheath 52 can be disposed adjacent to the distal sheath 54 in the delivery configuration. In some embodiments, the proximal sheath 52 can abut the distal sheath 54 in the delivery configuration. In some embodiments, the proximal sheath 52 can be axially spaced apart from the distal sheath 54 in the delivery configuration. In some embodiments, the proximal sheath 52 can be axially spaced apart from the distal sheath 54 by less than 20% of the overall length of the replacement heart valve implant 10 and / or the expandable framework 12 in the delivery configuration. In some embodiments, the proximal sheath 52 can be axially spaced apart from the distal sheath 54 by less than 15% of the overall length of the replacement heart valve implant 10 and / or the expandable framework 12 in the delivery configuration. In some embodiments, the proximal sheath 52 can be axially spaced apart from the distal sheath 54 by less than 10% of the overall length of the replacement heart valve implant 10 and / or expandable framework 12 in the delivery configuration. In some embodiments, the proximal sheath 52 can be axially spaced apart from the distal sheath 54 by less than 5% of the overall length of the replacement heart valve implant 10 and / or expandable framework 12 in the delivery configuration.

[0075] The components, features, and / or methods described herein may simplify the loading of the replacement heart valve implant 10 into a replacement heart valve system and / or implant delivery system 30. Simplified loading may reduce training requirements for physicians and / or hospital staff using and / or preparing the replacement heart valve system. Simplified loading may also reduce damage to the replacement heart valve system and / or its components. Simplified loading may also reduce the scrap rate and / or costs due to incorrect loading of the replacement heart valve implant 10. The components, features, and / or methods described herein may reduce the cost of manufacturing a replacement heart valve system compared to existing systems and / or products. Other advantages are also contemplated and / or expected.

[0076] In use, the implant delivery system 30 can be advanced percutaneously through the vascular system to a location adjacent to a treatment site. For example, the implant delivery system 30 can be advanced through the vascular system, across the aortic arch, and to a location adjacent to a defective native heart valve. Alternative approaches for treating defective aortic and / or other heart valves are also contemplated with the implant delivery system 30. After navigating the implant delivery system 30 and / or the implant-retaining portion to the treatment site, the proximal sheath 52 and / or the distal sheath 54 can be axially translated relative to one another to release the implant-retaining portion. The replacement heart valve implant 10 and / or the expandable framework 12 can be configured to transition from a radially collapsed configuration to a radially expanded configuration when not constrained by the implant-retaining portion. After axially translating the proximal sheath 52 and / or the distal sheath 54 away from each other and / or the stent holder 70, the replacement heart valve implant 10 and / or the expandable framework 12 may be transitioned to a radially expanded configuration, thereby translating the mounting tabs 15 radially outward from the grooves 72 of the stent holder 70, allowing the replacement heart valve implant 10 and / or the expandable framework 12 to be separated and / or removed from the implant delivery system 30. It may be appreciated that no rotation of the replacement heart valve implant 10 and / or the expandable framework 12 relative to the implant delivery system 30 and / or stent holder 70 is required to release the replacement heart valve implant 10 and / or the expandable framework 12.

[0077] In at least some interventions, the replacement heart valve implant 10 may be placed 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 placed in its place as a replacement. Some suitable, non-limiting materials, e.g., metallic and / or polymeric materials, for the implant delivery system 30, handle 40, elongate shaft assembly 50, proximal sheath 52, distal sheath 54, inner shaft 60, stent holder 70, atraumatic transition shield 80, and / or their components or elements are described below.

[0078] The various components of the replacement heart valve systems disclosed herein and materials that may be used for the various elements may include those generally associated with medical devices. For ease of explanation, this description refers to systems, but this is not intended to limit the devices, components, and methods described herein, and this description may also apply to other elements, members, components, or devices disclosed herein, such as, but not limited to, replacement heart valve implants, expandable frameworks, multiple leaflets, implant delivery systems, handles, elongate shaft assemblies, and / or elements or components thereof.

[0079] 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 any other suitable material.

[0080] Some examples of 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®), and the like. (trademark), 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.), perfluor Examples of suitable materials include poly(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefins, polystyrene, epoxies, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS 50A), polycarbonates, polyurethane silicone copolymers (e.g., Elast-Eon® or ChronoSil®), biocompatible polymers, other suitable materials, mixtures, combinations, copolymers thereof, polymer / metal composites, and the like.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.

[0081] 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, other nickel alloys such as nickel-chromium-molybdenum alloys (e.g., UNS: N06625 such as INCONEL® 625, UNS: N06022 such as HASTELLOY® C-22®, HASTELLOY® C27®, and the like). 6 (registered trademark), 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 B2®, etc.), 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.

[0082] In at least some embodiments, some or all of the systems and / or their components may be doped with, made from, or include radiopaque materials. Radiopaque materials are materials capable of producing a relatively bright image on a fluoroscopy screen or other imaging technique (e.g., ultrasound, etc.) during a medical procedure. This relatively bright image aids 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, etc. Other radiopaque marker bands and / or coils may also be incorporated into the system design to achieve the same results.

[0083] 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 produce substantial artifacts (e.g., gaps in the images). For example, certain ferromagnetic materials may not be suitable because they may produce artifacts in MRI images. The systems, or portions thereof, may be made of materials that MRI machines can image. 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.

[0084] In some embodiments, the systems and / or other elements disclosed herein may include a fabric material disposed over or within the structure. The fabric 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 fabric material may include a bioabsorbable material. Some examples of suitable fabric materials include, but are not limited to, polyethylene glycol (PEG), nylon, polytetrafluoroethylene (PTFE, ePTFE), polyolefin materials such as polyethylene, polypropylene, polyester, polyurethane, and / or blends or combinations thereof.

[0085] 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, polyvinyl, polymethyl acetate, polyamide, naphthalenedicarboxylene derivatives, natural silk, and polytetrafluoroethylene. Additionally, at least one of the synthetic yarns may be a metal yarn or a 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 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 with desired properties.

[0086] In some embodiments, the systems and / or other elements disclosed herein may include and / or be treated with suitable therapeutic agents. 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), and the like. etc.), anticoagulants (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, etc.), vascular cell growth promoters (growth factor inhibitors, growth factor receptor antagonists, transcription activators, and translation promoters, etc.), vascular cell growth inhibitors (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, etc.), cholesterol-lowering agents, vasodilators, and agents that interfere with endogenous vasoactive mechanisms.

[0087] It should be understood that this disclosure is in many respects merely illustrative. Changes may be made in details, particularly with respect to shape, size, and arrangement of steps, without exceeding the scope of the disclosure. This may include, to the extent appropriate, the use of any of the features of one illustrative embodiment in another embodiment. The scope of the disclosure is, of course, defined by the language in which the appended claims are expressed.

Claims

1. 1. A replacement heart valve implant, comprising: an expandable frame structure configured to transition between a radially collapsed configuration and a radially expanded configuration; a plurality of leaflets secured to the expandable framework; the expandable framework includes a tubular wall defining an inflow end and an outflow end; The replacement heart valve implant, wherein the inflow end includes a mounting tab extending radially inward from the tubular wall.

2. The replacement heart valve implant of claim 1 , wherein the mounting tabs extend radially inward from the tubular wall between about 1.5 millimeters and about 3.5 millimeters.

3. The replacement heart valve implant of claim 2 , wherein the mounting tabs extend radially inward from the tubular wall between about 2.0 millimeters and about 3.0 millimeters.

4. The replacement heart valve implant of any one of claims 1 to 3, wherein the attachment tabs are axially spaced apart from the plurality of leaflets.

5. 1. A replacement heart valve system comprising: A replacement heart valve implant according to any one of claims 1 to 4; 1. An implant delivery system comprising: The handle and an elongate shaft assembly extending distally from the handle; and the implant delivery system comprising: The replacement heart valve system, wherein a distal portion of the elongate shaft assembly includes an implant retaining portion configured to engage the replacement heart valve implant in the radially collapsed configuration.

6. 6. The replacement heart valve system of claim 5, wherein the elongate shaft assembly includes an outer tubular member extending distally from the handle and an inner shaft extending distally from the handle within the outer tubular member to a distal tip located distal to the implant holding portion.

7. The implant holding portion a proximal sheath configured to cover a proximal portion of the replacement heart valve implant in the radially folded configuration; a distal sheath configured to cover a distal portion of the replacement heart valve implant in the radially folded configuration; 7. The replacement heart valve system of claim 5 or 6, comprising:

8. The replacement heart valve system of claim 7 , wherein a distal portion of the replacement heart valve implant includes the inflow end.

9. 9. The replacement heart valve system of claim 5, wherein the implant holding portion includes a stent holder having grooves formed in an outer surface of the stent holder, the grooves being configured to receive the mounting tabs.

10. 10. The replacement heart valve system of claim 9, wherein the implant holding portion includes an atraumatic transition shield disposed proximally of the stent holder, the atraumatic transition shield including slots aligned with the grooves of the stent holder.

11. 11. The replacement heart valve system of claim 9, wherein the groove is formed as an L-shaped slot having a first portion extending axially and a second portion extending circumferentially from the first portion.

12. 12. The replacement heart valve system of claim 11, wherein the second portion of the L-shaped slot is axially spaced from a proximal end of the first portion of the L-shaped slot.

13. 1. A method of loading a replacement heart valve implant into a replacement heart valve system, comprising: positioning a replacement heart valve implant adjacent to an implant holding portion of an implant delivery system, the replacement heart valve implant having an expandable framework disposed in a radially collapsed configuration; positioning a distal sheath of the implant delivery system at least partially over a groove formed in an outer surface of a stent holder of the implant delivery system; inserting a mounting tab adjacent an inflow end of the expandable framework into the groove; and rotating the replacement heart valve implant relative to the implant delivery system.

14. the groove is formed as an L-shaped slot having a first portion extending axially and a second portion extending circumferentially from the first portion; 14. The method of claim 13, wherein rotating the replacement heart valve implant comprises translating the mounting tabs into the second portion of the L-shaped slot.

15. 15. The method of claim 13 or 14, wherein inserting the mounting tabs into the grooves comprises axially translating the replacement heart valve implant relative to the implant delivery system.

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