System for delivering a replacement heart valve implant - Patents.com

Abstract

A system for delivering a replacement heart valve implant may include a handle and a valve capsule, an inner shaft extending from the handle to the capsule, an outer sheath over the inner shaft and extending from the handle to the capsule, a positioning sheath over the outer sheath and extending from the handle, a guide tube within the handle, and a distal hub attached to the positioning sheath. The distal hub may be disposed within the guide tube and movable relative to the guide tube via rotation of the positioning sheath. A method of manufacturing the system may include positioning the proximal and distal hubs within the guide tube, setting a first predetermined distance between the proximal and distal capsule portions, moving the positioning sheath relative to the outer sheath to set a second predetermined distance between the hubs, and fixing the distal hub at the second predetermined distance within the guide tube.

Description

[Technical Field]

[0001] The present disclosure relates to medical devices, systems, and methods for making and / or using medical devices and / or systems. More particularly, the present disclosure relates to a system for delivering a replacement heart valve implant and / or a method for making a system for delivering a replacement heart valve implant. [Background technology]

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

[0003] In one example, a system for delivering a replacement heart valve implant may include a proximal handle, a valve capsule spaced from the proximal handle and configured to receive the replacement heart valve implant, an inner shaft extending distally from the proximal handle to the valve capsule, an outer sheath coaxially disposed over the inner shaft and extending distally from the proximal handle to the valve capsule, a positioning sheath coaxially disposed over the outer sheath and extending distally from the proximal handle to a distal end spaced proximally from the valve capsule, a guide tube disposed within the proximal handle, and a distal hub fixedly attached to the proximal end of the positioning sheath, the distal hub being disposed within the guide tube and selectively movable relative to the guide tube via rotation of the positioning sheath.

[0004] In addition or as an alternative to any example described herein, the distal hub includes a body portion and a helical ridge extending radially outward from the body portion. In addition to or in the alternative to any of the examples described herein, the guide tube includes at least one set screw threadably engaged with the wall of the guide tube and configured to extend between adjacent turns of the helical ridge.

[0005] Additionally or alternatively to any example described herein, the at least one set screw includes two or more set screws. In addition to or in the alternative to any of the examples described herein, the system may further include a proximal hub fixedly attached to the proximal end of the outer sheath, the proximal hub being disposed within the guide tube and selectively movable axially relative to the guide tube.

[0006] In addition or as an alternative to any example described herein, the proximal handle may include a first collar rotatably disposed about the guide tube, wherein rotation of the first collar about the guide tube is configured to move the proximal hub axially within the guide tube.

[0007] In addition to or as an alternative to any of the examples described herein, the distal hub acts as a hard stop for distal axial movement of the proximal hub. In addition to or as an alternative to any of the examples described herein, the valve capsule includes a proximal capsule portion fixedly attached to a distal portion of the outer sheath and a distal capsule portion fixedly attached to a distal portion of the inner shaft.

[0008] In addition to or as an alternative to any of the examples described herein, the proximal capsule portion is configured to cover a first portion of the replacement heart valve implant and the distal capsule portion is configured to cover a second portion of the replacement heart valve implant for percutaneous delivery of the replacement heart valve implant to a treatment site.

[0009] In addition to or in the alternative to any of the examples described herein, a method of manufacturing a system for delivering a replacement heart valve implant may include: positioning a proximal hub and a distal hub within a guide tube of a proximal handle of the system; an inner shaft extending through the guide tube to a distal capsule portion of the valve capsule spaced from the proximal handle, the valve capsule configured to receive a replacement heart valve implant; an outer sheath coaxially disposed over the inner shaft and extending distally from the proximal handle to a proximal capsule portion of the valve capsule, the proximal hub fixedly attached to a proximal end of the outer sheath; a positioning sheath coaxially disposed over the outer sheath and extending distally from the proximal handle to a distal end spaced proximally from the valve capsule, the distal hub fixedly attached to the proximal end of the positioning sheath; positioning, wherein at least one set screw is threadedly engaged with the wall of the guide tube; establishing a first predetermined distance between the proximal capsule portion and the distal capsule portion; axially moving the positioning sheath relative to the outer sheath to set a second predetermined distance between the proximal hub and the distal hub; and engaging at least one set screw with a body portion of the distal hub to axially secure the distal hub within the guide tube at a second predetermined distance from the proximal hub.

[0010] Additionally or alternatively to any example described herein, axially moving the positioning sheath relative to the outer sheath can include rotating the positioning sheath relative to the outer sheath.

[0011] In addition to or in the alternative to any example described herein, the distal hub includes a helical ridge extending radially outward from the body portion, and at least one set screw extends between adjacent turns of the helical ridge.

[0012] In addition or as an alternative to any of the examples described herein, engagement of the at least one set screw with the body portion of the distal hub prevents axial movement of the distal hub relative to the guide tube.

[0013] In addition to or as an alternative to any example described herein, the distal hub includes a proximal flange extending radially outward from the body portion farther than the helical ridge, and a distal flange extending radially outward from the body portion farther than the helical ridge.

[0014] Additionally or alternatively to any example described herein, the second predetermined distance is less than the first predetermined distance. In addition or as an alternative to any of the examples described herein, a system for delivering a replacement heart valve implant configured to transition between a collapsed configuration and an expanded configuration may include a proximal handle; a valve capsule spaced from the proximal handle and configured to receive and retain the replacement heart valve implant in the collapsed configuration; an inner shaft extending distally from the proximal handle to the valve capsule, the inner shaft extending axially through the replacement heart valve implant when the replacement heart valve implant is disposed within the valve capsule; an outer sheath coaxially disposed on the inner shaft and extending distally from the proximal handle to the valve capsule; a positioning sheath coaxially disposed on the outer sheath and extending distally from the proximal handle to a distal end spaced proximally from the valve capsule; a guide tube disposed within the proximal handle; and a distal hub fixedly attached to the proximal end of the positioning sheath and coaxially disposed on the inner shaft, the distal hub being disposed within the guide tube and selectively movable axially relative to the guide tube.

[0015] Additionally or alternatively to any of the examples described herein, the guide tube may be formed from a metallic material. In addition or as an alternative to any of the examples described herein, the distal hub may be formed from a polymeric material.

[0016] In addition or as an alternative to any example described herein, the distal hub includes a body portion and a helical ridge extending radially outward from the body portion. The guide tube includes at least one set screw threadedly engaged with a wall of the guide tube and extending radially inward therefrom. When the at least one set screw extends between adjacent turns of the helical ridge, rotation of the positioning sheath causes the distal hub to move axially relative to the guide tube when the at least one set screw disengages from the body portion of the distal hub, and mechanical interference between the at least one set screw and the helical ridge prevents axial movement of the distal hub relative to the guide tube when an axial force is applied to the distal hub.

[0017] In addition to or in the alternative to any of the examples described herein, the system may further include a proximal hub fixedly attached to the proximal end of the outer sheath, the proximal hub disposed within the guide tube and selectively movable axially relative to the guide tube, wherein distal movement of the proximal hub within the guide tube brings the proximal hub into contact with the distal hub and applies an axial force to the distal hub.

[0018] 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.

[0019] The present disclosure may be more fully understood by considering the following detailed description in conjunction with the accompanying drawings, in which: [Brief explanation of the drawings]

[0020] [Figure 1] 1 illustrates selected aspects of a system for delivering a replacement heart valve implant. [Figure 2] 2 is a partial cross-sectional view illustrating selected aspects of the system of FIG. 1 in a delivery configuration. [Figure 3]FIG. 3 is a detailed diagram illustrating selected aspects of the system of FIG. 2. [Figure 4] 4 is a partial cross-sectional view showing selected aspects of the system of FIGS. 1-3 in an expanded configuration. FIG. [Figure 5] 5A-5C are partial cross-sectional views illustrating selected aspects of the handle of the system of FIGS. 1-4. [Figure 6] 6A-6C are partial cross-sectional views illustrating selected aspects of the handle of the system of FIGS. 1-5. [Figure 7] 7A-7C are partial cross-sectional views illustrating selected aspects of the system of FIGS. 1-6. [Figure 8] 7A-7C are partial cross-sectional views illustrating selected aspects of the system of FIGS. 1-6. [Figure 9] 9A-9C are partial cross-sectional views illustrating selected aspects of the system of FIGS. 1-8 in a retracted configuration. DETAILED DESCRIPTION OF THE INVENTION

[0021] 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 intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present disclosure.

[0022] 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 exemplary embodiments of the present disclosure, not 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 present disclosure. However, for clarity and ease of understanding, not all features and / or elements may be shown in every drawing.

[0023] 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" 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) can be assumed to have their ordinary and customary definition as understood from and consistent with the context of this specification, unless otherwise specified.

[0024] 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.

[0025] As used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally used in its sense to include "and / or" unless the content clearly dictates otherwise. For ease of understanding, it should be noted that some features of the present disclosure may be described in the singular even though those features may be multiple or repeated within a disclosed embodiment. Each instance of a feature may include and / or be encompassed by the singular disclosure unless expressly stated to the contrary. For simplicity and clarity, not every element of the present disclosure is necessarily shown in every figure or described in detail below. However, it will be understood that the following description may apply equally to any and / or all of a component that is present more than once, unless expressly stated to the contrary. Moreover, for clarity, not every instance of some element or feature is shown in every figure.

[0026] 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 or system. 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.

[0027] The term "range" can be understood to mean the maximum measure of a stated or specified dimension unless the range or dimension is preceded by or identified as "minimum," which can be understood to mean the minimum measure of the stated or specified dimension. For example, an "outer range" can be understood to mean an outer dimension, a "radial range" can be understood to mean a radial dimension, and a "longitudinal range" can be understood to mean a longitudinal dimension. Each instance of "range" can 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" can be considered the maximum possible dimension measured according to the intended application, while a "minimum range" can be considered the smallest possible dimension measured according to the intended application. In some cases, a "range" can 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.

[0028] The terms "monolithic" and "unitary" shall generally refer to an element or elements made from or consisting of a single structure or base unit / element. Monolithic and / or unitary element shall exclude structures and / or features made by assembling or otherwise joining together multiple separate structures or elements.

[0029] It should be noted that references herein to "one embodiment," "some embodiments," "other embodiments," etc., indicate that the described embodiment may include a particular feature, structure, or characteristic, but that not all embodiments necessarily include that particular feature, structure, or characteristic. Moreover, such phrases do not necessarily refer to the same embodiment. Furthermore, if 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 use that 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 would be understood by one of ordinary skill in the art.

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

[0031] The heart of some mammals (e.g., humans) contains four heart valves: the tricuspid valve, the pulmonary valve, the aortic valve, and the mitral valve. Several relatively common conditions may involve or result from inefficiency, ineffectiveness, or complete failure of one or more of the valves in the heart. For example, failure of the aortic or mitral valve can have serious consequences for humans and, if not properly addressed, can lead to serious health conditions and / or death. Treating a defective heart valve poses another challenge in that the treatment often requires repair or complete replacement of the defective heart valve. Such treatments can be highly invasive for the patient. Disclosed herein are systems and / or methods that can be used in portions of the cardiovascular system to diagnose, treat, and / or repair the cardiovascular system. In some embodiments, the systems and / or methods disclosed herein may be used before and / or during a procedure to diagnose, treat, and / or repair a defective heart valve (e.g., an aortic valve, a mitral valve, etc.). Additionally, the replacement heart valve implant may be delivered percutaneously and therefore may be much less invasive to the patient. The systems and / or methods disclosed herein may also provide other desirable features and / or benefits, as described below.

[0032] It should be noted that for ease of understanding, some features of the present disclosure may be described in the singular even though those features may be plural 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. Accordingly, it will be understood that the following description may apply equally to any and / or all of components present in more than one system and / or method, unless expressly stated to the contrary.

[0033] Additionally, it should be noted that in any given figure, some features may not be shown or may be shown schematically for clarity and / or simplicity. Further details regarding some components and / or method steps may be shown in greater detail in other figures. The systems and / or methods disclosed herein may provide several desirable features and advantages, as described in more detail below. For purposes of this disclosure, the following description is directed to the treatment of a native aortic valve and is so described for brevity. However, this is not intended to be limiting, and those skilled in the art will recognize that the following description may also be applied to a mitral valve or another heart valve with no or minimal changes to the structure and / or scope of the present disclosure. Similarly, the systems and / or methods disclosed herein may have application and use in other parts of a patient's anatomy, such as, but not limited to, arteries, veins, and / or other body lumens.

[0034] FIG. 1 illustrates selected aspects of a system 100 for delivering a replacement heart valve implant 50 to a treatment site. The replacement heart valve implant 50 is shown schematically. The replacement heart valve implant 50 may include an expandable framework defining a central lumen, which may be substantially cylindrical in some embodiments. In some embodiments, the expandable framework may have a substantially circular cross-section. In some embodiments, the expandable framework may have a non-circular cross-section (e.g., D-shaped, elliptical, etc.). In some embodiments, the non-circular expandable framework may be used to repair a mitral valve or another non-circular valve within a patient's heart or body. Some suitable, but non-limiting, examples of materials that may be used to form the expandable framework are described below, including, but not limited to, metals and metal alloys, composites, ceramics, polymers, and the like.

[0035] The replacement heart valve implant 50 and / or the expandable framework may be configured to transition between a collapsed configuration (e.g., FIG. 2) and an expanded configuration (e.g., FIG. 4). In some embodiments, the collapsed configuration may be a radially collapsed configuration, and the expanded configuration may be a radially expanded configuration. In some embodiments, the expandable framework may be self-expanding. In some embodiments, the expandable framework may be self-biased toward the expanded configuration. In some embodiments, the expandable framework may be mechanically expandable. In some embodiments, the expandable framework may be balloon expandable. Other configurations are also contemplated.

[0036] It will be understood that the replacement heart valve implant 50 can be any type of heart valve (e.g., mitral valve, aortic valve, etc.). The replacement heart valve implant 50 may be configured to allow unidirectional flow through the replacement heart valve implant 50 from the inflow end to the outflow end. In some embodiments of the replacement heart valve implant 50, the expandable framework may define a lower crown proximate the inflow end of the replacement heart valve implant 50, an upper crown proximate the outflow end of the replacement heart valve implant 50, and a plurality of stabilizing arches extending downstream from the outflow end.

[0037] In some embodiments, the replacement heart valve implant 50 may include multiple valve leaflets disposed within the central lumen. The multiple valve leaflets may be coupled, secured, and / or fixedly attached to an expandable framework. In some embodiments, the multiple valve leaflets may be integrally formed with one another such that the multiple valve leaflets are formed as a single, integral and / or monolithic unit. In some embodiments, the multiple valve leaflets may be integrally formed with other structures, such as an inner skirt and / or an outer skirt, a base structure, a liner, etc. The multiple valve leaflets may be configured to substantially restrict fluid flow through the replacement heart valve implant 50 in the closed position. For example, in some embodiments, the free edges of the multiple valve leaflets may move to abut one another in the closed position to substantially restrict fluid flow through the replacement heart valve implant 50. The free edges of the multiple valve leaflets may move away from one another in the open position to allow fluid flow through the replacement heart valve implant 50.

[0038] In some embodiments, the replacement heart valve implant 50 may include an inner skirt. The inner skirt may be disposed on and / or extend along an inner surface of the expandable framework. In at least some embodiments, the inner skirt may be fixedly attached to the expandable framework. The inner skirt may direct fluid, such as blood, flowing through the replacement heart valve implant 50 toward the plurality of valve leaflets. In at least some embodiments, the inner skirt may be fixedly attached to and / or integrally formed with the plurality of valve leaflets. The inner skirt may ensure that fluid flows through the central lumen and not around the plurality of valve leaflets when they are in the closed position.

[0039] In some embodiments, the replacement heart valve implant 50 may include an outer skirt. In some embodiments, the outer skirt may be disposed on and / or extend along an outer surface of the expandable framework. In some embodiments, the outer skirt may be disposed between the expandable framework and the autologous tissue to prevent fluids, such as blood, from flowing downstream around the expandable framework and ensure that fluid flow can be stopped when the multiple valve leaflets are in the closed position.

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

[0041] In some embodiments, the inner skirt and / or outer skirt may comprise a polymer, such as a thermoplastic polymer. In some embodiments, the inner skirt and / or outer skirt may comprise at least 50 weight percent polymer. In some embodiments, one or more of the plurality of valve leaflets, the inner skirt, and / or the outer skirt may be formed from the same polymer or multiple polymers. In some embodiments, the polymer may be polyurethane. In some embodiments, the inner skirt and / or outer skirt may be substantially impermeable to fluids. In some embodiments, the inner skirt and / or outer skirt may be formed from thin tissue (e.g., bovine pericardium, etc.). In some embodiments, the inner skirt and / or outer skirt may be formed from a coated textile material. In some embodiments, the inner skirt and / or outer skirt may be formed from a non-porous and / or impermeable textile material. Other configurations are also contemplated. Some suitable, but non-limiting, examples of materials that may be used to form the inner skirt and / or outer skirt, including, but not limited to, polymers, composites, etc., are described below.

[0042] In some embodiments, the replacement heart valve implant 50 and / or the expandable framework may have an outer extent in an unconstrained configuration (e.g., in an expanded configuration) of about 23 millimeters (mm), about 25 mm, about 27 mm, about 30 mm, etc. In some embodiments, the replacement heart valve implant 50 and / or the expandable framework may have an outer extent in a collapsed configuration of about 10 mm, about 9 mm, about 8 mm, about 7 mm, about 6 mm, etc. Other configurations are also contemplated.

[0043] In some embodiments, system 100 may be configured to enable delivery of replacement heart valve implant 50 to a treatment site while the heart is still beating, for example, using minimally invasive surgical and / or percutaneous procedures. In some embodiments, system 100 may be configured to be introduced into the anatomical vasculature and advanced along the vasculature to the treatment site. In some embodiments, system 100 may be configured for introduction into the femoral artery and guided retrogradely into the heart via the descending aorta, the aortic arch, and the ascending aorta (sometimes referred to as transfemoral access). In some embodiments, system 100 may be insertable via the subclavian artery and guided retrogradely into the heart (sometimes referred to as transsubclavian access). In some embodiments, system 100 may be inserted directly into a heart chamber, such as a ventricle (e.g., the left ventricle), via a direct access route while the heart is beating. For example, the direct access route may be through an opening drilled in the apex of the heart (sometimes referred to as transapical access). Other configurations are also contemplated.

[0044] It can be appreciated that portions of the system 100 may be required to be advanced through tortuous and / or narrow body lumens during delivery and / or deployment of the replacement heart valve implant 50. Accordingly, it may be desirable to utilize components and / or design configurations that reduce the profile of portions of the system while maintaining sufficient strength (e.g., compression, torsion, etc.) and flexibility of the system as a whole.

[0045] In some embodiments, an introducer sheath may be inserted into the patient's anatomy to gain access to the vasculature. In some embodiments, the introducer sheath may include a valve or other means to prevent backflow of fluid from the introducer sheath. At least a portion of system 100 may be inserted into and / or through the introducer sheath into the vasculature for advancement to the treatment site.

[0046] In some embodiments, a system 100 for delivering a replacement heart valve implant 50 may include a proximal handle 110 and a valve capsule 120 spaced from the proximal handle 110. Figures 1 and 2 illustrate the valve capsule 120 in a delivery configuration. In the delivery configuration, the valve capsule 120 may be configured to receive and / or retain the replacement heart valve implant 50 in a folded configuration, as seen, for example, in Figure 2. The valve capsule 120 may be configured to cover at least a portion of the replacement heart valve implant 50 during delivery of the replacement heart valve implant 50 to a treatment site.

[0047] System 100 may include an inner shaft 130 extending distally from a proximal handle 110 to the valve capsule 120. System 100 may include an outer sheath 140 coaxially disposed over the inner shaft 130 and extending distally from the proximal handle 110 to the valve capsule 120. System 100 may include a positioning sheath 150 coaxially disposed over the outer sheath 140 and extending distally from the proximal handle 110 to a distal end 152 spaced proximally from the valve capsule 120. In some embodiments, the inner shaft 130, the outer sheath 140, and / or the positioning sheath 150 may be movable relative to one another, as described herein.

[0048] In some embodiments, valve capsule 120 can include a proximal capsule portion 122 and a distal capsule portion 124. In some embodiments, proximal capsule portion 122 can open toward distal capsule portion 124 and / or distal capsule portion 124 can open toward proximal capsule portion 122. For example, proximal capsule portion 122 can open distally and distal capsule portion 124 can open proximally.

[0049] In some embodiments, the proximal capsule portion 122 may have a length that is greater than the length of the distal capsule portion 124. For example, the ratio of the length of the proximal capsule portion 122 divided by the length of the distal capsule portion 124 may be at least 1.1, optionally at least 1.2, optionally at least 1.3, optionally at least 1.4, optionally at least 1.5, optionally at least 1.6, optionally at least 1.7, optionally at least 1.8, optionally at least 1.9, optionally at least 2.0, optionally at least 2.1, optionally at least 2.2, optionally at least 2.3, optionally at least 2.4, optionally at least 2.5, optionally at least 2.6, optionally at least 2.7, optionally at least 2.8, optionally at least 2.9, optionally at least 3, optionally at least 3.5, optionally at least 4, or optionally at least 4.5, or optionally at least 5.

[0050] For percutaneous delivery of the replacement heart valve implant 50 to a treatment site, the proximal capsule portion 122 may be configured to cover a first portion of the replacement heart valve implant 50, and the distal capsule portion 124 may be configured to cover a second portion of the replacement heart valve implant 50. The first portion of the replacement heart valve implant 50 may be different from the second portion of the replacement heart valve implant 50. The inner shaft 130 may extend longitudinally and / or axially through the replacement heart valve implant 50 when the replacement heart valve implant 50 is disposed within the valve capsule 120. In at least some embodiments, the inner shaft 130 may include a guidewire lumen extending therethrough.

[0051] The proximal capsule portion 122 may be fixedly attached to a distal portion of the outer sheath 140. The distal capsule portion 124 may be fixedly attached to a distal portion of the inner shaft 130. In at least some embodiments, the proximal capsule portion 122 may be longitudinally and / or axially spaced apart from the distal capsule portion 124. Thus, there may be no overlap between the proximal capsule portion 122 and the distal capsule portion 124 (e.g., the proximal capsule portion 122 does not longitudinally and / or axially overlap any portion of the distal capsule portion 124). In some embodiments, the proximal capsule portion 122 may be longitudinally and / or axially spaced apart from the distal capsule portion 124 by a first distance in the delivery configuration. In some embodiments, the first distance may be approximately 4 mm in the delivery configuration. In some embodiments, the first distance may be approximately 5 mm in the delivery configuration. In some embodiments, the first distance may be approximately 6 mm in the delivery configuration. Other configurations are also contemplated.

[0052] The proximal capsule portion 122 and the distal capsule portion 124 may be longitudinally and / or axially translatable relative to one another between a delivery configuration (e.g., FIG. 2) and a deployed configuration (e.g., FIG. 4). In some embodiments, the proximal capsule portion 122 and the outer sheath 140 may be longitudinally and / or axially translatable relative to the distal capsule portion 124 and the inner shaft 130 in opposite directions between the delivery configuration (e.g., FIG. 2) and the deployed configuration (e.g., FIG. 4). For example, the proximal capsule portion 122 and the outer sheath 140 may be proximally translatable, and the distal capsule portion 124 and the inner shaft 130 may be distally translatable. Other configurations are also contemplated.

[0053] In some embodiments, the proximal capsule portion 122 may be longitudinally and / or axially spaced a second distance from the distal capsule portion 124 in the deployed configuration (e.g., FIG. 4 ). The second distance may be greater than the first distance. In some embodiments, the second distance may be approximately 40 mm in the deployed configuration. In some embodiments, the second distance may be approximately 44 mm in the deployed configuration. In some embodiments, the second distance may be approximately 45 mm in the deployed configuration. In some embodiments, the second distance may be approximately 46 mm in the deployed configuration. In some embodiments, the second distance may be approximately 50 mm in the deployed configuration. Other configurations are also contemplated.

[0054] In the deployed configuration, the valve capsule 120 may be configured to release the replacement heart valve implant 50 such that the replacement heart valve implant 50 may expand from the compressed configuration to the expanded configuration. In at least some embodiments, the replacement heart valve implant 50 may be released and / or deployed at and / or within the treatment site (e.g., a native aortic valve, etc.).

[0055] As seen in FIGS. 2-4 , the system 100 may include a guide tube 160 disposed within the proximal handle 110. In at least some embodiments, the guide tube 160 may be formed from a metallic material. In some embodiments, the guide tube 160 may be formed from a polymeric material. The guide tube 160 may be formed from a composite material. Other configurations, including combinations thereof, are also contemplated. The guide tube 160 may include a lumen extending therethrough. The guide tube 160 may include a distal longitudinal slot 162 formed through a wall 164 of the guide tube 160 at a distal portion thereof. The guide tube 160 may include a proximal longitudinal slot 163 formed through a wall 164 of the guide tube 160 at a proximal portion thereof.

[0056] In some embodiments, the guide tube 160 includes at least one set screw 170 that is threadedly engaged with and extends radially inward from a wall 164 of the guide tube 160 at a distal portion of the guide tube 160, as seen in FIG. 3 . The guide tube 160 may include at least one threaded opening 168 formed in the wall 164 of the guide tube 160 that threadably receives and / or threadingly engages the at least one set screw 170. In some embodiments, the at least one set screw 170 may include two or more set screws. For example, the at least one set screw 170 may include two set screws, three set screws, four set screws, etc.

[0057] The system 100 may include a distal hub 180 fixedly attached to the proximal end of the positioning sheath 150. The distal hub 180 may be disposed within the guide tube 160 and selectively movable relative to the guide tube 160 via rotation of the positioning sheath 150 (e.g., FIGS. 7-8 ). In at least some embodiments, the distal hub 180 may be disposed within a lumen of the guide tube 160 within a distal portion of the guide tube 160. The distal hub 180 may be coaxially disposed on the inner shaft 130 and / or the outer sheath 140. The distal hub 180 may be coaxially and / or concentrically disposed within the guide tube 160.

[0058] The distal hub 180 may include a body portion 182 and a helical ridge 184 extending radially outward from the body portion 182, as shown in FIG. 3 . In some embodiments, the distal hub 180 may include a proximal flange 186 disposed proximate the proximal end of the distal hub 180 and / or a distal flange 188 disposed proximate the distal end of the distal hub 180. In some embodiments, the proximal flange 186 and / or the distal flange 188 may be configured to engage and / or slide along the wall 164 of the guide tube 160. In some embodiments, the proximal flange 186 may have a radial extent that is smaller than the inner diameter of the lumen of the guide tube 160. In some embodiments, the distal flange 188 may have a radial extent that is smaller than the inner diameter of the lumen of the guide tube 160. In at least some embodiments, proximal flange 186 may extend radially outward from body portion 182 further than helical ridge 184. In at least some embodiments, distal flange 188 may extend radially outward from body portion 182 further than helical ridge 184.

[0059] In some embodiments, the distal hub 180 may be formed from a polymeric material. In some embodiments, the distal hub 180 may be formed from a composite material. In some embodiments, the distal hub 180 may be formed from a metallic material. Other configurations, including combinations thereof, are also contemplated. In some embodiments, the distal hub 180 may be overmolded onto the proximal end of the positioning sheath 150. In some embodiments, the distal hub 180 may be formed separately from the positioning sheath 150 and later fixedly attached to the proximal end of the positioning sheath 150 by adhesive bonding, welding, a friction and / or interference fit, mechanical attachment, etc.

[0060] In some embodiments, system 100 may include a proximal hub 190 fixedly attached to the proximal end of outer sheath 140. Proximal hub 190 may be disposed within guide tube 160 and selectively movable axially relative to guide tube 160. In at least some embodiments, proximal hub 190 may be disposed within the lumen of guide tube 160. Proximal hub 190 may be disposed within a distal portion of guide tube 160 proximal to distal hub 180.

[0061] The proximal hub 190 may include a guide member 192 extending radially outward from the proximal hub 190. In some embodiments, the proximal hub 190 may include a proximal flange 194 disposed proximate the proximal end of the proximal hub 190 and / or a distal flange 196 disposed proximate the distal end of the proximal hub 190. In some embodiments, the proximal flange 194 and / or the distal flange 196 may be configured to engage and / or slide along the wall 164 of the guide tube 160. In some embodiments, the proximal flange 194 may have a radial extent that is smaller than the inner diameter of the lumen of the guide tube 160. In some embodiments, the distal flange 196 may have a radial extent that is smaller than the inner diameter of the lumen of the guide tube 160.

[0062] In some embodiments, the proximal hub 190 may be formed from a polymeric material. In some embodiments, the proximal hub 190 may be formed from a composite material. In some embodiments, the proximal hub 190 may be formed from a metallic material. Other configurations, including combinations thereof, are also contemplated. In some embodiments, the proximal hub 190 may be overmolded onto the proximal end of the outer sheath 140. In some embodiments, the proximal hub 190 may be formed separately from the outer sheath 140 and later fixedly attached to the proximal end of the outer sheath 140 by adhesive bonding, welding, a friction and / or interference fit, mechanical attachment, etc.

[0063] System 100 and / or proximal handle 110 may include a first collar 200 rotatably disposed about a distal portion of guide tube 160, as seen in Figures 2 and 4. In some embodiments, rotation of first collar 200 about the distal portion of guide tube 160 may be configured to axially translate proximal hub 190 within guide tube 160.

[0064] System 100 and / or proximal handle 110 may include a first helical guide 210 disposed radially outward of a distal portion of guide tube 160 and radially inward of first collar 200. First helical guide 210 may be configured to rotate about the distal portion of guide tube 160. In some embodiments, first collar 200 may be non-rotatably engaged with first helical guide 210 such that rotation of first collar 200 rotates first helical guide 210. In some embodiments, at least a portion of guide member 192 may be disposed within distal longitudinal slot 162 of guide tube 160. Guide member 192 may also extend within first helical guide 210.

[0065] In use, as first collar 200 rotates about the distal portion of guide tube 160, first helical guide 210 may also rotate about the distal portion of guide tube 160, thereby urging and / or moving guide member 192 and / or proximal hub 190 axially along distal longitudinal slot 162. As a result, outer sheath 140 may move longitudinally and / or axially as proximal hub 190 moves longitudinally and / or axially within the distal portion of guide tube 160, thereby moving proximal capsule portion 122 longitudinally and / or axially between the delivery configuration and the deployed configuration.

[0066] In some embodiments, the system 100 and / or the proximal handle 110 may include a sliding block 220 slidably disposed within a proximal portion of the guide tube 160. The inner shaft 130 may extend longitudinally and / or axially through the sliding block 220. In at least some embodiments, the sliding block 220 may be rigidly secured to the inner shaft 130. In some embodiments, the sliding block 220 may be rigidly secured to the inner shaft 130 using a locking element 222, such as a set screw, pin, or the like. In some embodiments, the system 100 and / or the proximal handle 110 may include a second collar 230 rotatably disposed about a proximal portion of the guide tube 160. In some embodiments, rotation of the second collar 230 about the proximal portion of the guide tube 160 may be configured to move the inner shaft 130 axially within and / or relative to the outer sheath 140, the positioning sheath 150, and / or the guide tube 160.

[0067] The system 100 and / or the proximal handle 110 may include a second helical guide 240 disposed radially outward of the proximal portion of the guide tube 160 and radially inward of the second collar 230. The second helical guide 240 may be configured to rotate about the proximal portion of the guide tube 160. In some embodiments, the second collar 230 may be non-rotatably engaged with the second helical guide 240 such that rotation of the second collar 230 rotates the second helical guide 240. The locking element 222 may extend radially outward from the slide block 220. In some embodiments, at least a portion of the locking element 222 may be disposed within the proximal longitudinal slot 163 of the guide tube 160. The locking element 222 may also extend into the second helical guide 240.

[0068] In use, as second collar 230 rotates about the proximal portion of guide tube 160, second helical guide 240 may also rotate about the proximal portion of guide tube 160, thereby urging and / or moving locking element 222 and / or sliding block 220 axially along proximal longitudinal slot 163. As a result, inner shaft 130 may move longitudinally and / or axially as sliding block 220 moves longitudinally and / or axially within the proximal portion of guide tube 160, thereby moving distal capsule portion 124 longitudinally and / or axially between the delivery configuration and the deployed configuration.

[0069] Thus, during use, the first collar 200 and the second collar 230 may be used together, or in some alternative configurations separately, to release and / or deploy the replacement heart valve implant 50 from the valve capsule 120 at the treatment site by moving the proximal capsule portion 122 and the distal capsule portion 124 toward and / or away from each other into the deployed configuration.

[0070] In some embodiments, a method of manufacturing and / or assembling a system 100 for delivering a replacement heart valve implant 50 may include positioning a proximal hub 190 and a distal hub 180 within a guide tube 160 of a proximal handle 110 of the system 100, as seen in FIGS. 4-6. In some embodiments, the at least one set screw 170 may be configured to extend between adjacent turns of the helical ridge 184 of the distal hub 180, as seen, for example, in FIGS. 2-5. In at least some embodiments, the at least one set screw 170 may be disengaged from (e.g., spaced apart from and / or not in contact with) the body portion 182 of the distal hub 180.

[0071] A method of manufacturing and / or assembling a system 100 for delivering a replacement heart valve implant 50 may include establishing a first predetermined distance 250 (e.g., FIG. 4 ) between the proximal capsule portion 122 and the distal capsule portion 124 of the valve capsule 120. The first predetermined distance 250 may correspond to the second distance in the deployed configuration described above. In at least some embodiments, the second distance is the first predetermined distance 250.

[0072] Setting the first predetermined distance 250 may include moving the outer sheath 140 longitudinally and / or axially relative to the inner shaft 130. In some embodiments, moving the outer sheath 140 longitudinally and / or axially relative to the inner shaft 130 may include moving the proximal hub 190 proximally and / or distally within the guide tube 160. After setting the first predetermined distance 250, the proximal capsule portion 122 and the distal capsule portion 124 of the valve capsule 120 may be held in a fixed position relative to each other. In some embodiments, the proximal capsule portion 122 and the distal capsule portion 124 of the valve capsule 120 may be held in a fixed position relative to each other using a fastener. In some embodiments, a user or technician assembling the system 100 may hold the proximal capsule portion 122, and the distal capsule portion 124 of the valve capsule 120 may be held in a fixed position relative to each other. Other configurations, including combinations thereof, are also contemplated.

[0073] In some embodiments, first predetermined distance 250 may be approximately 40 mm. In some embodiments, first predetermined distance 250 may be approximately 42 mm. In some embodiments, first predetermined distance 250 may be approximately 44 mm. In some embodiments, first predetermined distance 250 may be approximately 46 mm. In some embodiments, first predetermined distance 250 may be approximately 48 mm. In some embodiments, first predetermined distance 250 may be approximately 50 mm. Other dimensions and / or values ​​are contemplated.

[0074] In some embodiments, a method of manufacturing and / or assembling a system 100 for delivering a replacement heart valve implant 50 can include axially moving the positioning sheath 150 relative to the outer sheath 140 to set a second predetermined distance 260 (e.g., FIG. 6 ) between the proximal hub 190 and the distal hub 180. In some embodiments, axially moving the positioning sheath 150 relative to the outer sheath 140 can include rotating the positioning sheath 150 relative to the outer sheath 140, as seen in FIGS. 7-8 . As discussed herein, the at least one set screw 170 can be configured to extend between adjacent turns of the helical ridge 184 of the distal hub 180. In this manner, when the at least one set screw 170 extends between adjacent turns of the helical ridge 184 of the distal hub 180, rotation of the positioning sheath 150 relative to the outer sheath 140 may also rotate the distal hub 180 relative to the at least one set screw 170 and / or the outer sheath 140, such that the distal hub 180 moves longitudinally and / or axially relative to the guide tube 160 when the at least one set screw 170 disengages from the body portion 182 of the distal hub 180.

[0075] As the positioning sheath 150 and / or distal hub 180 are rotated, the distal hub 180 may be advanced distally and / or retracted proximally relative to the at least one set screw 170 and / or outer sheath 140. For example, as shown in FIG. 7 , clockwise rotation of the positioning sheath 150, viewed from proximal to distal, may rotate the distal hub clockwise and advance the distal hub 180 distally within the guide tube 160 and / or relative to the at least one set screw 170 and / or outer sheath 140. Similarly, as shown in FIG. 8 , counterclockwise rotation of the positioning sheath 150, viewed from proximal to distal, may rotate the distal hub counterclockwise and retract the distal hub 180 proximally within the guide tube 160 and / or relative to the at least one set screw 170 and / or outer sheath 140. Other configurations, including configurations opposite to those explicitly described above, are also contemplated.

[0076] In some embodiments, when an axial force is applied to the distal hub 180 while the at least one set screw 170 extends between adjacent turns of the helical ridge 184 of the distal hub 180, mechanical interference between the at least one set screw 170 and the helical ridge 184 may prevent longitudinal and / or axial movement of the distal hub 180 relative to the guide tube 160, and the at least one set screw 170 extends between adjacent turns of the helical ridge 184 of the distal hub 180. For example, applying longitudinal and / or axial force alone to the positioning sheath 150 and / or the distal hub 180 may be insufficient to move the distal hub 180 longitudinally and / or axially relative to the guide tube 160 when the at least one set screw 170 extends between adjacent turns of the helical ridge 184 of the distal hub 180. Rotation of the positioning sheath 150 and the distal hub 180 fixedly attached thereto is required to cause longitudinal and / or axial movement of the distal hub 180 relative to the guide tube 160 when at least one set screw 170 extends between adjacent turns of the helical ridge 184 of the distal hub 180.

[0077] In some embodiments, second predetermined distance 260 may be approximately 40 mm. In some embodiments, second predetermined distance 260 may be approximately 41 mm. In some embodiments, second predetermined distance 260 may be approximately 42 mm. In some embodiments, second predetermined distance 260 may be approximately 43 mm. In some embodiments, second predetermined distance 260 may be approximately 44 mm. In some embodiments, second predetermined distance 260 may be approximately 45 mm. Other dimensions and / or values ​​are also contemplated. In at least some embodiments, second predetermined distance 260 may be less than first predetermined distance 250.

[0078] In some embodiments, the at least one set screw 170 may be configured to engage with the body portion 182 of the distal hub 180, as seen in FIGS. 7-8 , for example. In some embodiments, the method may include engaging the at least one set screw 170 with the body portion 182 of the distal hub 180 to longitudinally and / or axially secure the distal hub 180 within the guide tube 160 at a second predetermined distance 260 from the proximal hub 190. The engagement of the at least one set screw 170 with the body portion 182 of the distal hub 180 may substantially prevent rotation of the distal hub 180 relative to the at least one set screw 170 and / or the guide tube 160. Similarly, engagement of the at least one set screw 170 with the body portion 182 of the distal hub 180 may prevent longitudinal and / or axial movement of the distal hub 180 relative to the at least one set screw 170 and / or guide tube 160 due to the aforementioned mechanical interference between the at least one set screw 170 and the helical ridge 184 of the distal hub 180.

[0079] In some embodiments, a method of manufacturing and / or assembling a system 100 for delivering a replacement heart valve implant 50 may include attaching a first spiral guide 210 and / or a first collar 200 to the proximal handle 110 over a distal portion of the guide tube 160. In some embodiments, a method of manufacturing and / or assembling a system 100 for delivering a replacement heart valve implant 50 may include attaching a second spiral guide 240 and / or a second collar 230 to the proximal handle 110 over a proximal portion of the guide tube 160. In some embodiments, a method of manufacturing and / or assembling a system 100 for delivering a replacement heart valve implant 50 may include attaching a handle shell over the first spiral guide 210 distal to the first collar 200. The first spiral guide 210 may be configured to rotate within the handle shell when the first collar 200 is rotated relative to the handle shell and / or the guide tube 160.

[0080] In use, the system 100 may be used to deliver a replacement heart valve implant 50 to a treatment site. As described herein, the replacement heart valve implant 50 in a collapsed configuration may be disposed within the valve capsule 120 in a delivery configuration, shown in FIGS. 1-2 . The proximal capsule portion 122 may be longitudinally and / or axially spaced a first distance from the distal capsule portion 124 in the delivery configuration (e.g., FIGS. 1-2 ). At the treatment site, the proximal handle 110 may be used, actuated, and / or manipulated to transition the valve capsule 120 to a deployed configuration to release the replacement heart valve implant 50, thereby allowing the replacement heart valve implant 50 to transition from the collapsed configuration (e.g., FIGS. 1-2 ) to an expanded configuration (e.g., FIG. 4 ). In the deployed configuration (e.g., FIG. 4), the proximal capsule portion 122 may be longitudinally and / or axially spaced apart from the distal capsule portion 124 by a second distance (e.g., first predetermined distance 250).

[0081] After deployment of the replacement heart valve implant 50, the proximal handle 110 can be used to actuate and / or manipulate the valve capsule 120 to transition toward and / or into the retracted configuration shown in FIG. 9 . After deployment of the replacement heart valve implant 50, distal longitudinal and / or axial movement of the proximal hub 190 within and / or relative to the guide tube 160 can bring the proximal hub 190 into contact with the distal hub 180 and apply an axial force to the distal hub 180 in a distal direction. The distal longitudinal and / or axial movement of the proximal hub 190 may be achieved and / or effected by rotation of the first collar 200 and / or first helical guide 210, thereby urging and / or driving the guide member 192 of the proximal hub 190 distally within the distal longitudinal slot 162. Distal hub 180 may act as a hard stop for distal longitudinal and / or axial movement of proximal hub 190, thereby positioning proximal capsule portion 122 and distal capsule portion 124 a third distance apart in the retracted configuration (e.g., FIG. 9 ). The third distance may be less than the first distance.

[0082] In some embodiments, the third distance may be about 2 mm. In some embodiments, the third distance may be about 2.5 mm. In some embodiments, the third distance may be about 3 mm. In some embodiments, the third distance may be about 3.5 mm. In some embodiments, the third distance may be about 4 mm. Other configurations and / or values ​​are contemplated.

[0083] Because the third distance is shorter than the first distance, there may be a smaller gap between the proximal capsule portion 122 and the distal capsule portion 124 for capturing adjacent patient anatomy, other medical devices, etc. However, it may be important and / or beneficial to avoid contact between the proximal capsule portion 122 and the distal capsule portion 124. Thus, the distal hub 180, acting as a hard stop for the proximal hub 190, prevents the proximal capsule portion 122 from colliding with, contacting, and / or axially overlapping the distal capsule portion 124 as the valve capsule 120 transitions to the retracted configuration, thereby preventing damage to the valve capsule 120 and / or injury to the patient that may result from such damage during retraction of the system 100.

[0084] When the valve capsule 120 transitions from the deployed configuration toward and / or to the retracted configuration, the proximal handle 110 and / or first collar 200 (in conjunction with the first helical guide 210) may provide relatively easy distal movement of the proximal hub 190 when the replacement heart valve implant 50 is not present within the valve capsule 120. To reduce the training requirements for the practitioner and / or improve the consistency of results, the distal hub 180 is used as a hard stop for the proximal hub 190 when closing the valve capsule 120 (e.g., transitioning the valve capsule 120 from the deployed configuration to the retracted configuration), preventing longitudinal and / or axial movement or translation during use. The mechanical interference between the at least one set screw 170 and the helical ridge 184 prevents longitudinal and / or axial movement of the distal hub 180, thereby enhancing the function of the distal hub 180 as a hard stop for the proximal hub 190. However, assembly of the system 100 during manufacturing requires that at least some adjustability be built into the system 100 to account for tolerances, etc. The same combination of features that function to prevent longitudinal and / or axial movement of the distal hub 180 (e.g., the at least one set screw 170 and the helical ridge 184, and the mechanical interference therebetween) also allows for adjustability in the positioning of the distal hub 180 via rotation of the positioning sheath 150 and / or the distal hub 180, such that longitudinal and / or axial movement of the distal hub 180 relative to the guide tube 160 occurs when the at least one set screw 170 is disengaged from the body portion 182 of the distal hub 180.

[0085] The various components of the devices disclosed herein, and materials that can be used for the various elements thereof, may include those commonly associated with medical devices and devices used with and / or associated with medical devices. For purposes of simplicity, the following description will refer to systems. However, this is not intended to limit the devices and methods described herein, as this discussion may apply to other elements, members, components, or devices disclosed herein, such as, but not limited to, a replacement heart valve implant, a proximal handle, a valve capsule, an inner shaft, an outer sheath, a positioning sheath, a guide tube, a proximal hub, a distal hub, at least one set screw, and / or elements or components thereof.

[0086] In some embodiments, the system and / or its components may be made from metals, metal alloys, polymers (some examples of which are disclosed below), metal-polymer composites, ceramics, combinations thereof, etc., or other suitable materials.

[0087] 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., available under the trade name PEBAX®), ethylene vinyl acetate copolymers (EVA), silicones, polyethylene (PE), MA, etc. RLEX® 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 (e.g., GRILAMID®), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefin, polystyrene, epoxy, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS)50A), polycarbonate, polyisobutylene (PIB), polyisobutylene polyurethane (PIBU), polyurethane silicone copolymers (e.g., Elast-Eon™ or ChronoSil™), ionomers, biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers, polymer / metal composites, and the like. In some embodiments, the sheath can be blended with a liquid crystal polymer (LCP). For example, the mixture can contain up to about 6% LCP.

[0088] 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, for example, nickel-chromium-molybdenum alloys (e.g., UNS: N06625 such as INCONEL® 625, UNS: N06022 such as HASTELLOY® C-22®, UNS: N06022 such as HASTELLOY® C-22®, and the like). 276™, 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™), 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.

[0089] In some embodiments, some or all of the system and / or its components may be doped with, made of, or otherwise include a radiopaque material. A radiopaque material is understood to be a material that can produce a relatively bright image on a fluoroscopy screen or another imaging technique (e.g., ultrasound) during a medical procedure. This relatively bright image aids the user in determining the location of the system. 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 also be incorporated into the system design to achieve the same results.

[0090] In some embodiments, the system is provided with a degree of Magnetic Resonance Imaging (MRI) compatibility. For example, the system and / or its components or portions may be made of materials that do not substantially distort images and do not introduce substantial artifacts (e.g., gaps in the image). For example, certain ferromagnetic materials may not be suitable because they may introduce artifacts into MRI images. The system 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:R44003, such as ELGILOY®, PHYNOX®, etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS:R44035, such as MP35-N™), nitinol, etc., and others.

[0091] In some embodiments, the system may include a textile material. 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 invention 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 also include carbon fiber, glass fiber, or ceramic fiber. In some embodiments, the threads may be 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 system.

[0092] 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)); antiprotein and / or antibacterial agents (such as 2-methacryloyloxyethyl phosphorylcholine (MPC) and its polymers or copolymers); 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); anti-tumor / anti-proliferative / anti-mitotic agents (such as paclitaxel, 5-fluorouracil, cisplatin, vinblastine, vincristine, epothilones, endostatin, angiostatin, and thymidine kinase inhibitors); anesthetic agents (such as lidocaine, bupivacaine, and ropivacaine); anticoagulants (D-Phe-Pro-Ar g 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 (growth factor inhibitors, growth factor receptor antagonists, transcription activators, and translation promoters); vascular cell growth inhibitors (growth factor inhibitors, growth factor receptor antagonists, transcription inhibitors, translation inhibitors, replication inhibitors, inhibitory antibodies, growth factor antibodies against leukemia cells, bifunctional molecules consisting of a growth factor and a cytotoxin, bifunctional molecules consisting of an antibody and a cytotoxin, etc.); immunosuppressants (e.g., the "olimus" family of drugs, rapamycin analogs, macrolide antibiotics, biolimus, everolimus, zotarolimus, temsirolimus, picrolimus, novolimus, myolimus, tacrolimus, sirolimus, pimecrolimus, etc.); cholesterol-lowering agents; vasodilators; and agents that interfere with endogenous vasoactive mechanisms.

[0093] It should 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 exemplary 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 system for delivering a replacement heart valve implant, comprising: a proximal handle; and a valve capsule spaced from the proximal handle, the valve capsule configured to receive the replacement heart valve implant; an inner shaft extending distally from the proximal handle to the valve capsule; an outer sheath coaxially disposed over the inner shaft and extending distally from the proximal handle to the valve capsule; a positioning sheath coaxially disposed over the outer sheath and extending distally from the proximal handle to a distal end spaced proximally from the valve capsule; a guide tube disposed within the proximal handle; a distal hub fixedly attached to the proximal end of the positioning sheath, the distal hub being disposed within and selectively movable relative to the guide tube via rotation of the positioning sheath; A system comprising:

2. The system of claim 1 , wherein the distal hub includes a body portion and a helical ridge extending radially outward from the body portion.

3. The system of claim 2 , wherein the guide tube includes at least one set screw configured to threadably engage a wall of the guide tube and extend between adjacent turns of the helical ridge.

4. The system of claim 3 , wherein the at least one set screw comprises two or more set screws.

5. 5. The system of claim 1, further comprising a proximal hub fixedly attached to the proximal end of the outer sheath, the proximal hub being disposed within the guide tube and selectively movable axially relative to the guide tube.

6. the proximal handle includes a first collar rotatably disposed about the guide tube; The system of claim 5 , wherein rotation of the first collar about the guide tube is configured to axially translate the proximal hub within the guide tube.

7. The system of claim 5 , wherein the distal hub acts as a hard stop for distal axial movement of the proximal hub.

8. 8. The system of claim 1, wherein the valve capsule comprises a proximal capsule portion fixedly attached to a distal portion of the outer sheath and a distal capsule portion fixedly attached to a distal portion of the inner shaft.

9. 9. The system of claim 8, wherein the proximal capsule portion is configured to cover a first portion of the replacement heart valve implant and the distal capsule portion is configured to cover a second portion of the replacement heart valve implant for percutaneous delivery of the replacement heart valve implant to a treatment site.

10. 1. A method of manufacturing a system for delivering a replacement heart valve implant, comprising: positioning a proximal hub and a distal hub within a guide tube of a proximal handle of the system; an inner shaft extends through the guide tube to a distal capsule portion of a valve capsule spaced from the proximal handle, the valve capsule configured to receive the replacement heart valve implant; an outer sheath coaxially disposed over the inner shaft and extending distally from the proximal handle to a proximal capsule portion of the valve capsule, the proximal hub being fixedly attached to a proximal end of the outer sheath; a positioning sheath coaxially disposed over the outer sheath and extending distally from the proximal handle to a distal end spaced proximally from the valve capsule, the distal hub being fixedly attached to a proximal end of the positioning sheath; positioning, wherein at least one set screw is threadedly engaged with a wall of the guide tube; establishing a first predetermined distance between the proximal capsule portion and the distal capsule portion; axially moving the positioning sheath relative to the outer sheath to set a second predetermined distance between the proximal hub and the distal hub; and engaging the at least one set screw with a body portion of the distal hub to axially secure the distal hub within the guide tube at the second predetermined distance from the proximal hub.

11. The method of claim 10, wherein axially moving the positioning sheath relative to the outer sheath comprises rotating the positioning sheath relative to the outer sheath.

12. 12. The method of claim 10 or 11, wherein the distal hub includes a helical ridge extending radially outward from the body portion, and the at least one set screw extends between adjacent turns of the helical ridge.

13. The method of claim 12 , wherein engagement of the at least one set screw with the body portion of the distal hub prevents axial movement of the distal hub relative to the guide tube.

14. 14. The method of claim 12 or 13, wherein the distal hub includes a proximal flange extending radially outward from the body portion farther than the helical ridge and a distal flange extending radially outward from the body portion farther than the helical ridge.

15. The method of any one of claims 10 to 14, wherein the second predetermined distance is less than the first predetermined distance.

Images