Replacement heart valve implant delivery system

Abstract

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

Description

Cross - Reference to Related Applications

[0001] This application claims priority to U.S. Provisional Application No. 63 / 402,231, filed Aug. 30, 2022, the entire disclosure of which is incorporated herein by reference. Technical Field

[0002] The present disclosure relates to medical devices, systems, and methods of 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 of making a system for delivering a replacement heart valve implant. Background Art

[0003] A variety of in vivo medical devices have been developed for medical use, such as for intravascular use. Some of these devices include guidewires, catheters, medical device systems (such as for stents, grafts, replacement valves, etc.). These devices are manufactured by any of a variety of different manufacturing methods and can be used according to any of a variety of methods. Among known medical devices and methods, each has certain advantages and disadvantages. There is a continuing need to provide alternative medical devices and alternative methods of making and using medical devices. Summary of the Invention

[0004] In one example, a system for delivering a replacement heart valve implant can include a proximal handle and a valve sac spaced apart from the proximal handle, the valve sac being configured to receive a replacement heart valve implant; an inner shaft extending distally from the proximal handle to the valve sac; an outer sheath coaxially disposed on the inner shaft and extending distally from the proximal handle to the valve sac; a positioning sheath coaxially disposed on the outer sheath and extending distally from the proximal handle to a distal end spaced apart from the proximal end of the valve sac; 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 being selectively movable relative to the guide tube by rotation of the positioning sheath.

[0005] In addition to or as an alternative to any of the examples described herein, the distal hub includes a body portion and a helical ridge extending radially outwardly from the body portion.

[0006] In addition to or as an alternative to any of the examples described herein, the guide tube includes at least one set screw that threadedly engages the wall of the guide tube and is configured to extend between adjacent turns of the helical ridge.

[0007] In addition to or as an alternative to any of the examples described herein, the at least one set screw includes two or more set screws.

[0008] In addition to or as an 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 being selectively axially movable relative to the guide tube.

[0009] In addition to or as an alternative to any of the examples described herein, the proximal handle includes a first collar rotatably disposed around the guide tube. Rotating the first collar around the guide tube may be configured to axially move the proximal hub within the guide tube.

[0010] In addition to or as an alternative to any of the examples described herein, the distal hub serves as a hard stop for the proximal hub to move distally axially.

[0011] In addition to or as an alternative to any of the examples described herein, the valve sac includes a proximal sac portion fixedly attached to the distal portion of the outer sheath and a distal sac portion fixedly attached to the distal portion of the inner shaft.

[0012] In addition to or as an alternative to any of the examples described herein, the proximal sac portion is configured to cover a first portion of the replacement heart valve implant, and the distal sac portion is configured to cover a second portion of the replacement heart valve implant for percutaneous delivery of the replacement heart valve implant to the treatment site.

[0013] In addition to or as an 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, wherein: an inner shaft extends through the guide tube to a distal sac portion of a valve sac spaced apart from the proximal handle, the valve sac being configured to receive a replacement heart valve implant; the proximal hub is fixedly attached to the proximal end of an outer sheath coaxially disposed on the inner shaft and extending distally from the proximal handle to the proximal sac portion of the valve sac; the distal hub is fixedly attached to the proximal end of a positioning sheath coaxially disposed on the outer sheath and extending distally from the proximal handle to a distal end spaced apart from the proximal end of the valve sac; and at least one set screw is threadedly engaged with the wall of the guide tube; setting a first predetermined distance between the proximal sac portion and the distal sac 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 fix the distal hub within the guide tube at a second predetermined distance from the proximal hub.

[0014] In addition to or as an alternative to any of the examples described herein, axially moving the positioning sheath relative to the outer sheath includes rotating the positioning sheath relative to the outer sheath.

[0015] In addition to or as an alternative to any of the examples described herein, 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.

[0016] In addition to or as an alternative to any of the examples described herein, the 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.

[0017] In addition to or as an alternative to any of the examples described herein, the distal hub includes a proximal flange that extends radially outward from the body portion further than the helical ridge and a distal flange that extends radially outward from the body portion further than the helical ridge.

[0018] In addition to or as an alternative to any of the examples described herein, the second predetermined distance is less than the first predetermined distance.

[0019] In addition to 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 can include: a proximal handle and a valve sac spaced apart from the proximal handle, the valve sac configured to receive and hold a replacement heart valve implant in the collapsed configuration; an inner shaft extending distally from the proximal handle to the valve sac, wherein when the replacement heart valve implant is disposed within the valve sac, the inner shaft axially passes through the replacement heart valve implant; an outer sheath coaxially disposed on the inner shaft and extending distally from the proximal handle to the valve sac; a positioning sheath coaxially disposed on the outer sheath and extending distally from the proximal handle to a distal end spaced apart from the valve sac in the proximal direction; 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 disposed within the guide tube and selectively axially movable relative to the guide tube.

[0020] In addition to or as an alternative to any of the examples described herein, the guide tube is formed of a metallic material.

[0021] In addition to or as an alternative to any of the examples described herein, the distal hub is formed of a polymeric material.

[0022] In addition to or as an alternative to any of the examples 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 that threadedly engages the wall of the guide tube and extends radially inward therefrom. When the at least one set screw extends between adjacent turns of the helical ridge: upon disengagement of the at least one set screw from the body portion of the distal hub, rotation of the positioning sheath causes axial movement of the distal hub relative to the guide tube; and when an axial force is applied to the distal hub, 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.

[0023] In addition to or as an alternative to any 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 being selectively axially movable relative to the guide tube. 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 in the distal direction.

[0024] The foregoing summary of some embodiments, aspects, and / or examples is not intended to describe every disclosed embodiment or every implementation of the present disclosure. The following figures and detailed description more particularly illustrate these embodiments. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] The present disclosure may be more fully understood when considered in conjunction with the following detailed description, in which: Figure 1 Selected aspects of a system for delivering a replacement heart valve implant are shown; Figure 2 is a partial cross-sectional view showing Figure 1 selected aspects of the system in a delivery configuration; Figure 3 is a detailed view showing Figure 2 selected aspects of the system; Figure 4 is a partial cross-sectional view showing Figures 1 - 3 selected aspects of the system in a deployed configuration; Figure 5 is a partial cross-sectional view showing Figures 1 - 4 selected aspects of the handle of the system; Figure 6 is a partial cross-sectional view showing Figures 1 - 5 selected aspects of the handle of the system; Figures 7 - 8 is a partial cross-sectional view showing Figures 1 - 6 selected aspects of the system; and Figure 9 is a partial cross-sectional view showing Figures 1 - 8 selected aspects of the system in a retracted configuration.

[0026] Although aspects of the present disclosure may be susceptible to various modifications and alternative forms, specific details have been shown by way of example in the drawings and will be described in detail below. 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. DETAILED DESCRIPTION

[0027] The following description should be read in conjunction with the accompanying drawings, which are not necessarily drawn to scale, wherein like reference numerals in several views represent like elements. The detailed description and the drawings are intended to illustrate example embodiments of the present disclosure but do not limit the present disclosure. Those skilled in the art will recognize that the various elements described and / or shown 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 every feature and / or element is shown in every drawing.

[0028] For the terms defined below, these definitions shall apply unless a different definition is given in the claims or elsewhere in this specification.

[0029] All numerical values herein are assumed to be modified by the term "about" whether or not explicitly indicated. In the context of numerical values, the term "about" generally refers to a range of numbers that a person skilled in the art would consider equivalent to the stated value (e.g., having the same function or result). In many instances, the term "about" may include numbers rounded to the nearest significant digit. Other uses of the term "about" (e.g., in non-numerical contexts) shall be assumed to have their ordinary and customary definition, as understood from and consistent with the context of the specification, unless otherwise specified.

[0030] Numerical ranges expressed with endpoints include all numbers within that range, including the endpoints (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0031] Although some suitable dimensions, ranges, and / or values related to various components, features, and / or specifications are disclosed, those skilled in the art inspired by the present disclosure will understand that the desired dimensions, ranges, and / or values may deviate from those explicitly disclosed.

[0032] As used in this specification and the appended claims, the singular forms "a" and "the" include plural referents unless the context clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally used in its inclusive sense of "and / or" unless the context clearly dictates otherwise. It should be noted that for ease of understanding, certain features of the present disclosure may be described in the singular, even though these features may be plural or recurring in the disclosed embodiments. Each instance of a feature may include and / or be included in the singular disclosure unless clearly stated to the contrary. For simplicity and clarity, not all elements of the present disclosure are necessarily shown in each drawing or discussed in detail below. However, it should be understood that the following discussion applies equally to any and / or all components having multiple elements unless clearly stated to the contrary. Additionally, for clarity, not all instances of some elements or features are shown in each drawing.

[0033] Relative terms such as "proximal", "distal", "advance", "retract" and their variants are generally considered relative to the positioning, orientation and / or operation of various components by the user / operator / handler of the device, where "proximal" and "retract" indicate or refer to closer to or towards the user, while "distal" and "advance" indicate or refer to away from the user. In some cases, the terms "proximal" and "distal" may be arbitrarily designated to aid in the understanding of the present disclosure, and this will be 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 lumen, such as within a body lumen, blood vessel or within a device or system. Still other relative terms, such as "axial", "circumferential", "longitudinal", "lateral", "radial", etc. and their variants generally refer to the direction and / or orientation relative to the central longitudinal axis of the disclosed structure or device.

[0034] The term "range" shall be understood to refer to the maximum measurement of the stated or identified dimension, unless the range or dimension being discussed is preceded by "minimum" or identified as "minimum", in which case it shall be understood to refer to the minimum measurement of the stated or identified dimension. For example, an "outer range" may be understood to refer to an outer dimension, a "radial range" may be understood to refer to a radial dimension, a "longitudinal range" may be understood to refer to a longitudinal dimension, etc. Each instance of "range" may be different (e.g., axial, longitudinal, lateral, radial, circumferential, etc.), and will be apparent to those skilled in the art from their respective contexts of use. Generally, a "range" may be considered the maximum possible dimension measured according to the intended use, while a "minimum range" may be considered the minimum possible dimension measured according to the intended use. In some cases, a "range" may generally be measured orthogonally in a plane and / or cross-section, but may also be measured in different ways depending on the specific context, such as but not limited to angular measurement, radial measurement, circumferential measurement (e.g., along an arc), etc.

[0035] The terms "integral" and "one-piece" generally refer to one or more components made or composed of a single structure or basic unit / element. Integral and / or one-piece components shall exclude structures and / or features made by assembling or otherwise connecting multiple discrete structures or elements.

[0036] Note that references in the specification to "one embodiment", "some embodiments", "other embodiments", etc., indicate that the described embodiments may include a particular feature, structure, or characteristic, but not every embodiment necessarily includes that particular feature, structure, or characteristic. Moreover, these phrases do not necessarily refer to the same embodiment. Further, when a particular feature, structure, or characteristic is described in connection with an embodiment, those skilled in the art will know to use that particular feature, structure, or characteristic in other embodiments without explicit description, unless explicitly stated to the contrary. That is, the individual elements described below, even if not explicitly shown in a particular combination, are still contemplated to be combinable or arranged with each other to form other additional embodiments, or to supplement and / or enrich the described embodiments, as would be understood by those of ordinary skill in the art.

[0037] For clarity, certain identifying numerical nomenclature (e.g., first, second, third, fourth, etc.) may be used throughout the description and / or claims to name and / or distinguish various described and / or claimed features. It should be understood that the numerical nomenclature is not intended to be limiting and is merely exemplary. In some embodiments, for the sake of brevity and clarity, the previously used numerical nomenclature may be changed and deviated from. That is, a feature identified as a "first" element may later be referred to as a "second" element, a "third" element, etc., or may be omitted entirely, and / or different features may be referred to as a "first" element. The meaning and / or designation in each instance will be apparent to those skilled in the art.

[0038] The hearts of some mammals (such as humans, etc.) include four heart valves: the tricuspid valve, the pulmonary valve, the aortic valve, and the mitral valve. Some relatively common medical conditions may include the underfunctioning, ineffectiveness, or complete failure of one or more valves within the heart, or the consequences thereof. For example, the failure of the aortic valve or the mitral valve can have a serious impact on humans and, if not properly treated, may lead to serious health conditions and / or death. Treating defective heart valves presents other challenges because treatment typically requires repairing or directly replacing the defective heart valve. Such treatment can be highly invasive to the patient. The systems and / or methods disclosed herein can be used for a part of the cardiovascular system to diagnose, treat, and / or repair the system. In some embodiments, the systems and / or methods disclosed herein can be used before and / or during a procedure to diagnose, treat, and / or repair a defective heart valve (such as the aortic valve, the mitral valve, etc.). Additionally, replacement heart valve implants can be delivered percutaneously and are thus much less invasive to the patient. The systems and / or methods disclosed herein can also provide other desired features and / or benefits as described below.

[0039] Note that, for ease of understanding, some features of the present disclosure may be described in the singular, even though such features may be plural or repeated in the disclosed embodiments. Each feature instance may include and / or be included in the singular disclosure, unless expressly stated to the contrary. Accordingly, it should be understood that the following discussion applies equally to any and / or all components of a system and / or method having multiple elements, unless expressly stated to the contrary.

[0040] Additionally, it should be noted that, in any given drawing, for clarity and / or simplicity, some features may not be shown, or may be shown schematically. More details regarding some components and / or method steps may be shown in greater detail in other drawings. The systems and / or methods disclosed herein may provide many desirable features and benefits as described in greater detail below. For the purposes of the present disclosure, the following discussion is directed to the treatment of the native aortic valve and will be described as such for brevity. However, this is not intended to be limiting, as those skilled in the art will recognize that the following discussion may also be applied to the mitral valve or another heart valve with little or no change to the structure and / or scope of the present disclosure. Similarly, the systems and / or methods disclosed herein may have applications and uses in other parts of the patient's anatomy, such as, but not limited to, arteries, veins, and / or other body cavities.

[0041] Figure 1 Selected aspects of a system 100 for delivering a replacement heart valve implant 50 to a treatment site are shown. The replacement heart valve implant 50 is shown schematically. The replacement heart valve implant 50 may include an expandable frame defining a central lumen, which may be generally cylindrical in some embodiments. In some embodiments, the expandable frame may have a generally circular cross-section. In some embodiments, the expandable frame may have a non-circular (e.g., D-shaped, oval, etc.) cross-section. In some embodiments, the non-circular expandable frame may be used to repair the mitral valve or another non-circular valve in a patient's heart or body. Some suitable but non-limiting examples of materials that may be used to form the expandable frame are described below, including but not limited to metals and metal alloys, composite materials, ceramics, polymers, etc.

[0042] The replacement heart valve implant 50 and / or the expandable frame may be configured to transition between a contracted configuration (e.g., Figure 2 ) and an expanded configuration (e.g., Figure 4 ). In some embodiments, the contracted configuration may be a radially contracted configuration, while the expanded configuration may be a radially expanded configuration. In some embodiments, the expandable frame may be self-expanding. In some embodiments, the expandable frame may be self-biased to the expanded configuration. In some embodiments, the expandable frame may be mechanically expandable. In some embodiments, the expandable frame may be balloon-expandable. Other configurations are also contemplated.

[0043] It should 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 can be configured to allow fluid to flow unidirectionally from an inflow end to an outflow end through the replacement heart valve implant 50. In some embodiments of the replacement heart valve implant 50, the expandable frame can define a lower crown near the inflow end of the replacement heart valve implant 50, an upper crown near the outflow end of the replacement heart valve implant 50, and a plurality of stabilizing arches extending downstream from the outflow end.

[0044] In some embodiments, the replacement heart valve implant 50 can include a plurality of valve leaflets disposed within a central lumen. The plurality of valve leaflets can be connected, fixed, and / or securely attached to the expandable frame. In some embodiments, the plurality of valve leaflets can be integrally formed with each other such that the plurality of valve leaflets are formed as a single integral and / or unitary element. In some embodiments, the plurality of valve leaflets can be integrally formed with other structures (e.g., an inner skirt and / or an outer skirt, a base structure, a lining, etc.). The plurality of valve leaflets can be configured to substantially prevent fluid from flowing through the replacement heart valve implant 50 in a closed position. For example, in some embodiments, the free edges of the plurality of valve leaflets can be in contact with each other in the closed position to substantially prevent fluid from flowing through the replacement heart valve implant 50. The free edges of the plurality of valve leaflets can be separated from each other in an open position to allow fluid to flow through the replacement heart valve implant 50.

[0045] In some embodiments, the replacement heart valve implant 50 can include an inner skirt. The inner skirt can be disposed on and / or extend along the inner surface of the expandable frame. In at least some embodiments, the inner skirt can be securely attached to the expandable frame. The inner skirt can direct fluid such as blood to flow towards the plurality of valve leaflets as it flows through the replacement heart valve implant 50. In at least some embodiments, the inner skirt can be securely attached to and / or integrally formed with the plurality of valve leaflets. The inner skirt can ensure that fluid flows through the central lumen when the valve leaflets are in a closed position without bypassing the plurality of valve leaflets.

[0046] In some embodiments, the replacement heart valve implant 50 can include an outer skirt. In some embodiments, the outer skirt can be disposed on and / or extend along the outer surface of the expandable frame. In some embodiments, the outer skirt can be disposed between the expandable frame and natural tissue to prevent fluid such as blood from flowing around the expandable frame in a downstream direction, thereby ensuring that the plurality of valve leaflets can prevent fluid flow in a closed position.

[0047] In some embodiments, the plurality of valve leaflets may be constructed of a polymer (such as a thermoplastic polymer). In some embodiments, the plurality of valve leaflets may comprise at least 50% by weight of a 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.

[0048] In some embodiments, the inner skirt and / or the outer skirt may comprise a polymer, such as a thermoplastic polymer. In some embodiments, the inner skirt and / or the outer skirt may comprise at least 50% by weight of a 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 the outer skirt may be substantially fluid-impermeable. In some embodiments, the inner skirt and / or the outer skirt may be formed from thin tissue (such as bovine pericardium, etc.). In some embodiments, the inner skirt and / or the outer skirt may be formed from a coated fabric material. In some embodiments, the inner skirt and / or the outer skirt may be formed from a non-porous and / or impermeable fabric material. Other configurations are also contemplated. Some suitable but non-limiting examples of materials that can be used to form the inner skirt and / or the outer skirt are described below, including but not limited to polymers, composite materials, etc.

[0049] In some embodiments, the outer extent of the replacement heart valve implant 50 and / or the expandable frame in an unconstrained configuration (such as in the expanded configuration) may be about 23 millimeters (mm), about 25 mm, about 27 mm, about 30 mm, etc. In some embodiments, the outer extent of the replacement heart valve implant 50 and / or the expandable frame in the contracted configuration may be about 10 mm, about 9 mm, about 8 mm, about 7 mm, about 6 mm, etc. Other configurations are also contemplated.

[0050] In some embodiments, the system 100 may be configured to allow delivery of the replacement heart valve implant 50 to the treatment site while the heart is beating, such as using minimally invasive surgery and / or percutaneous procedures. In some embodiments, the system 100 may be configured to introduce into the anatomical vascular system and advance along the vascular system to the treatment site. In some embodiments, the system 100 may be configured to introduce into the femoral artery and guide retrograde through the descending aorta, aortic arch, and ascending aorta to the heart (sometimes referred to as the trans-femoral approach). In some embodiments, the system 100 may be inserted through the subclavian artery and guided retrograde to the heart (sometimes referred to as the trans-subclavian approach). In some embodiments, the system 100 may be directly inserted into a chamber of the heart (such as the left ventricle) through a direct approach while the heart is beating. For example, the direct approach may be through an opening made at the apex of the heart (sometimes referred to as the trans-apical approach). Other configurations are also contemplated.

[0051] It will be appreciated that during the delivery and / or deployment of the replacement heart valve implant 50, portions of the system 100 may need to be advanced through tortuous and / or narrow body cavities. Accordingly, it is desirable to utilize components and / or design configurations that can reduce the profile of the system portions while maintaining sufficient strength (e.g., compressive, torsional, etc.) and flexibility of the overall system.

[0052] In some embodiments, an introducer sheath may be inserted into a patient's anatomy to access the vascular system. In some embodiments, the introducer sheath may include a valve or other device to prevent fluid backflow from the introducer sheath. At least a portion of the system 100 may be inserted into and / or through the introducer sheath into the vascular system for advancement to the treatment site.

[0053] In some embodiments, the system 100 for delivering the replacement heart valve implant 50 may include a proximal handle 110 and a valve sac 120 spaced from the proximal handle 110. Figure 1 and Figure 2 The valve sac 120 is shown in a delivery configuration. In the delivery configuration, the valve sac 120 may be configured to receive and / or hold the replacement heart valve implant 50 in a contracted configuration, such as as Figure 2 shown. The valve sac 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 the treatment site.

[0054] The system 100 may include an inner shaft 130 extending distally from the proximal handle 110 to the valve sac 120. The system 100 may include an outer sheath 140 coaxially disposed on the inner shaft 130 and extending distally from the proximal handle 110 to the valve sac 120. The system 100 may include a positioning sheath 150 coaxially disposed on the outer sheath 140 and extending distally from the proximal handle 110 to a distal end 152 spaced proximally from the valve sac 120. In some embodiments, the inner shaft 130, the outer sheath 140, and / or the positioning sheath 150 may be movable relative to each other, as discussed herein.

[0055] In some embodiments, the valve sac 120 may include a proximal sac portion 122 and a distal sac portion 124. In some embodiments, the proximal sac portion 122 may open toward the distal sac portion 124, and / or the distal sac portion 124 may open toward the proximal sac portion 122. For example, the proximal sac portion 122 may open distally while the distal sac portion 124 may open proximally.

[0056] In some embodiments, the length of the proximal sac portion 122 may be greater than the length of the distal sac portion 124. For example, the ratio of the length of the proximal sac portion 122 divided by the length of the distal sac 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.

[0057] The proximal sac portion 122 may be configured to cover a first portion of the prosthetic heart valve implant 50, while the distal sac portion 124 may be configured to cover a second portion of the prosthetic heart valve implant 50 for percutaneous delivery of the prosthetic heart valve implant 50 to a treatment site. The first portion of the prosthetic heart valve implant 50 may be different from the second portion of the prosthetic heart valve implant 50. When the prosthetic heart valve implant 50 is disposed within the valve sac 120, the inner shaft 130 may longitudinally and / or axially pass through the prosthetic heart valve implant 50. In at least some embodiments, the inner shaft 130 may include a guidewire lumen extending therethrough.

[0058] The proximal sac portion 122 may be securely attached to the distal portion of the outer sheath 140. The distal sac portion 124 may be securely attached to the distal portion of the inner shaft 130. In at least some embodiments, the proximal sac portion 122 may be longitudinally and / or axially spaced from the distal sac portion 124. Accordingly, there may be no overlap between the proximal sac portion 122 and the distal sac portion 124 (e.g., the proximal sac portion 122 does not overlap any portion of the distal sac portion 124 longitudinally and / or axially). In some embodiments, in the delivery configuration, the proximal sac portion 122 may be longitudinally and / or axially spaced from the distal sac portion 124 by a first distance. In some embodiments, in the delivery configuration, the first distance may be approximately 4 mm. In some embodiments, in the delivery configuration, the first distance may be approximately 5 mm. In some embodiments, in the delivery configuration, the first distance may be approximately 6 mm. Other configurations are also contemplated.

[0059] The proximal sac portion 122 and the distal sac portion 124 may longitudinally and / or axially translate relative to each other between a delivery configuration (e.g., Figure 2 ) and a deployment configuration (e.g., Figure 4 ). In some embodiments, in the delivery configuration (e.g., Figure 2) and deployment configurations (e.g., Figure 4 ) between the proximal bladder portion 122 and the outer sheath 140 can be longitudinally and / or axially translated relative to the distal bladder portion 124 and the inner shaft 130 in opposite directions. For example, the proximal bladder portion 122 and the outer sheath 140 can be translated proximally while the distal bladder portion 124 and the inner shaft 130 can be translated distally. Other configurations are also contemplated.

[0060] In some embodiments, in a deployment configuration (e.g., Figure 4 ) the proximal bladder portion 122 can be longitudinally and / or axially spaced apart from the distal bladder portion 124 by a second distance. The second distance can be greater than the first distance. In some embodiments, in the deployment configuration, the second distance can be about 40 mm. In some embodiments, in the deployment configuration, the second distance can be about 44 mm. In some embodiments, in the deployment configuration, the second distance can be about 45 mm. In some embodiments, in the deployment configuration, the second distance can be about 46 mm. In some embodiments, in the deployment configuration, the second distance can be about 50 mm. Other configurations are also contemplated.

[0061] In the deployment configuration, the valve bladder 120 can be configured to release the replacement heart valve implant 50 such that the replacement heart valve implant 50 can expand from a compressed configuration to an expanded configuration. In at least some embodiments, the replacement heart valve implant 50 can be released and / or deployed at and / or within a treatment site (e.g., native aortic valve, etc.).

[0062] As Figures 2 - 4 shown, the system 100 can include a guide tube 160 disposed within the proximal handle 110. In at least some embodiments, the guide tube 160 can be formed of a metallic material. In some embodiments, the guide tube 160 can be formed of a polymeric material. The guide tube 160 can be formed of a composite material. Other configurations including combinations thereof are also contemplated. The guide tube 160 can include a lumen extending therethrough. The guide tube 160 can include a distal longitudinal slot 162 formed through the wall 164 of the guide tube 160 in the distal portion of the guide tube 160. The guide tube 160 can include a proximal longitudinal slot 163 formed through the wall 164 of the guide tube 160 in the proximal portion of the guide tube 160.

[0063] In some embodiments, the guide tube 160 includes at least one setscrew 170 that threadedly engages the wall 164 of the guide tube 160 in the distal portion of the guide tube 160 and extends radially inward therefrom, as Figure 3As shown. The guide tube 160 may include at least one threaded hole 168 formed in the wall 164 of the guide tube 160 to threadedly receive and / or engage 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.

[0064] The system 100 may include a distal hub 180 fixedly attached to the proximal end of the positioning sheath 150. The distal hub 180 is disposed within the guide tube 160 and may be selectively moved relative to the guide tube 160 by rotation of the positioning sheath 150 (e.g., Figures 7 - 8 ). In at least some embodiments, the distal hub 180 may be disposed within the lumen of the guide tube 160 in the 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.

[0065] The distal hub 180 may include a body portion 182 and a helical ridge 184 extending radially outward from the body portion 182, as Figure 3 shown. In some embodiments, the distal hub 180 may include a proximal flange 186 disposed near the proximal end of the distal hub 180 and / or a distal flange 188 disposed near 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 radial extent (radial dimension, radial span) of the proximal flange 186 may be less than the inner diameter of the lumen of the guide tube 160. In some embodiments, the radial extent of the distal flange 188 may be less than the inner diameter of the lumen of the guide tube 160. In at least some embodiments, the proximal flange 186 extends radially outward from the body portion 182 a greater distance than the helical ridge 184. In at least some embodiments, the distal flange 188 extends radially outward from the body portion 182 a greater distance than the helical ridge 184.

[0066] In some embodiments, the distal hub 180 may be formed of a polymeric material. In some embodiments, the distal hub 180 may be formed of a composite material. In some embodiments, the distal hub 180 may be formed of 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 then fixedly attached to the proximal end of the positioning sheath 150 by means such as adhesive bonding, welding, friction and / or interference fit, mechanical connection, etc.

[0067] In some embodiments, system 100 may include a proximal hub 190 fixedly attached to the proximal end of outer sheath 140. The proximal hub 190 may be disposed within the guide tube 160 and may be selectively axially movable relative to the guide tube 160. In at least some embodiments, the proximal hub 190 may be disposed within the lumen of the guide tube 160. The proximal hub 190 may be disposed within the distal portion of the guide tube 160, proximal to the distal hub 180.

[0068] 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 near the proximal end of the proximal hub 190 and / or a distal flange 196 disposed near 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 radial extent (radial dimension, radial span) of the proximal flange 194 may be less than the inner diameter of the lumen of the guide tube 160. In some embodiments, the radial extent of the distal flange 196 may be less than the inner diameter of the lumen of the guide tube 160.

[0069] In some embodiments, the proximal hub 190 may be formed of a polymeric material. In some embodiments, the proximal hub 190 may be formed of a composite material. In some embodiments, the proximal hub 190 may be formed of 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 then fixedly attached to the proximal end of the outer sheath 140 by means such as adhesive bonding, welding, friction and / or interference fit, mechanical connection, etc.

[0070] System 100 and / or the proximal handle 110 may include a first collar 200 rotatably disposed around the distal portion of the guide tube 160, as Figure 2 and Figure 4 shown. In some embodiments, rotating the first collar 200 around the distal portion of the guide tube 160 may be configured to axially move the proximal hub 190 within the guide tube 160.

[0071] System 100 and / or the proximal handle 110 may include a first helical guide 210 disposed radially outward of the distal portion of the guide tube 160 and radially inward of the first collar 200. The first helical guide 210 may be configured to rotate about the distal portion of the guide tube 160. In some embodiments, the first collar 200 may be non-rotatably engaged with the first helical guide 210 such that rotation of the first collar 200 drives rotation of the first helical guide 210. In some embodiments, at least a portion of the guide member 192 may be disposed within the distal longitudinal slot 162 of the guide tube 160. The guide member 192 may also extend into the first helical guide 210.

[0072] In use, when the first collar 200 rotates about the distal portion of the guide tube 160, the first helical guide 210 may also rotate about the distal portion of the guide tube 160, thereby pushing and / or causing the guide member 192 and / or the proximal hub 190 to move axially along the distal longitudinal slot 162. Thus, when the proximal hub 190 moves longitudinally and / or axially within the distal portion of the guide tube 160, the outer sheath 140 may move longitudinally and / or axially, thereby causing the proximal balloon portion 122 to move longitudinally and / or axially between the delivery configuration and the deployment configuration.

[0073] In some embodiments, system 100 and / or the proximal handle 110 may include a slider 220 slidably disposed within the proximal portion of the guide tube 160. The inner shaft 130 may pass longitudinally and / or axially through the slider 220. In at least some embodiments, the slider 220 may be fixedly fastened to the inner shaft 130. In some embodiments, the slider 220 may be fixedly fastened to the inner shaft 130 using locking elements 222 such as set screws, pins, etc. In some embodiments, system 100 and / or the proximal handle 110 may include a second collar 230 rotatably disposed about the proximal portion of the guide tube 160. In some embodiments, rotating the second collar 230 about the proximal portion of the guide tube 160 may be configured to cause the inner shaft 130 to move axially within and / or relative to the outer sheath 140, the positioning sheath 150, and / or the guide tube 160.

[0074] 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 drives rotation of the second helical guide 240. The locking element 222 may extend radially outward from the slider 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.

[0075] In use, when the second collar 230 rotates about the proximal portion of the guide tube 160, the second helical guide 240 may also rotate about the proximal portion of the guide tube 160, thereby pushing and / or moving the locking element 222 and / or the slider 220 axially along the proximal longitudinal slot 163. Accordingly, when the slider 220 moves longitudinally and / or axially within the proximal portion of the guide tube 160, the inner shaft 130 may move longitudinally and / or axially, thereby moving the distal sac portion 124 longitudinally and / or axially between the delivery configuration and the deployment configuration.

[0076] Accordingly, in 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 sac 120 at the treatment site by moving the proximal sac portion 122 and the distal sac portion 124 away from each other to the deployment configuration.

[0077] In some embodiments, a method of manufacturing and / or assembling the system 100 for delivering the replacement heart valve implant 50 may include positioning the proximal hub 190 and the distal hub 180 within the guide tube 160 of the proximal handle 110 of the system 100, as Figures 4 - 6 shown. In some embodiments, at least one set screw 170 may be configured to extend between adjacent turns of the helical ridges 184 of the distal hub 180, such as Figures 2 - 5 shown. In at least some embodiments, at least one set screw 170 may be disengaged from the body portion 182 of the distal hub 180 (e.g., spaced from and / or not in contact with the body portion 182).

[0078] A method of manufacturing and / or assembling the system 100 for delivering the replacement heart valve implant 50 may include setting a first predetermined distance 250 between the proximal sac portion 122 and the distal sac portion 124 of the valve sac 120 (e.g., Figure 4 ). The first predetermined distance 250 may correspond to the second distance in the deployment configuration discussed above. In at least some embodiments, the second distance is the first predetermined distance 250.

[0079] Setting the first predetermined distance 250 may include longitudinally and / or axially moving the outer sheath 140 relative to the inner shaft 130. In some embodiments, longitudinally and / or axially moving the outer sheath 140 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 sac portion 122 and the distal sac portion 124 of the valve sac 120 may be held in a fixed position relative to each other. In some embodiments, the proximal sac portion 122 and the distal sac portion 124 of the valve sac 120 may be held in a fixed position relative to each other using a fixing device. In some embodiments, a user or technician assembling the system 100 may hold the proximal sac portion 122 and the distal sac portion 124 of the valve sac 120 in a fixed position relative to each other. Other configurations including combinations thereof are also contemplated.

[0080] In some embodiments, the first predetermined distance 250 may be approximately 40 mm. In some embodiments, the first predetermined distance 250 may be approximately 42 mm. In some embodiments, the first predetermined distance 250 may be approximately 44 mm. In some embodiments, the first predetermined distance 250 may be approximately 46 mm. In some embodiments, the first predetermined distance 250 may be approximately 48 mm. In some embodiments, the first predetermined distance 250 may be approximately 50 mm. Other sizes and / or values are also contemplated.

[0081] In some embodiments, a method of manufacturing and / or assembling a system 100 for delivering a replacement heart valve implant 50 may include axially moving a positioning sheath 150 relative to the outer sheath 140 to set a second predetermined distance 260 between the proximal hub 190 and the distal hub 180 (e.g., Figure 6 ). In some embodiments, axially moving the positioning sheath 150 relative to the outer sheath 140 may include rotating the positioning sheath 150 relative to the outer sheath 140, as Figures 7 - 8 shown. As discussed herein, at least one set screw 170 may be configured to extend between adjacent turns of the helical ridges 184 of the distal hub 180. Thus, when at least one set screw 170 extends between adjacent turns of the helical ridges 184 of the distal hub 180, rotating the positioning sheath 150 relative to the outer sheath 140 may also cause the distal hub 180 to rotate relative to at least one set screw 170 and / or the outer sheath 140, such that when at least one set screw 170 disengages from the body portion 182 of the distal hub 180, the distal hub 180 moves longitudinally and / or axially relative to the guide tube 160.

[0082] As the positioning sheath 150 and / or the distal hub 180 rotate, the distal hub 180 can be advanced distally or retracted proximally relative to at least one set screw 170 and / or the outer sheath 140. For example, when viewed from proximal to distal, a clockwise rotation of the positioning sheath 150 can cause the distal hub to rotate clockwise and cause the distal hub 180 to be advanced distally within the guide tube 160 and / or relative to at least one set screw 170 and / or the outer sheath 140, as Figure 7 shown. Similarly, when viewed from proximal to distal, a counterclockwise rotation of the positioning sheath 150 can cause the distal hub to rotate counterclockwise and cause the distal hub 180 to be retracted proximally within the guide tube 160 and / or relative to at least one set screw 170 and / or the outer sheath 140, as Figure 8 shown. Other configurations are also contemplated, including configurations contrary to the explicitly described examples above.

[0083] In some embodiments, when at least one set screw 170 extends between adjacent turns of the helical ridges 184 of the distal hub 180, the mechanical interference between the at least one set screw 170 and the helical ridges 184 can prevent the distal hub 180 from longitudinally and / or axially moving relative to the guide tube 160 when an axial force is applied to the distal hub 180. For example, when at least one set screw 170 extends between adjacent turns of the helical ridges 184 of the distal hub 180, merely applying a longitudinal and / or axial force to the positioning sheath 150 and / or the distal hub 180 may not be sufficient to cause the distal hub 180 to longitudinally and / or axially move relative to the guide tube 160. When at least one set screw 170 extends between adjacent turns of the helical ridges 184 of the distal hub 180, it is necessary to rotate the positioning sheath 150 and the attached distal hub 180 to cause the distal hub 180 to longitudinally and / or axially move relative to the guide tube 160.

[0084] In some embodiments, the second predetermined distance 260 can be approximately 40 mm. In some embodiments, the second predetermined distance 260 can be approximately 41 mm. In some embodiments, the second predetermined distance 260 can be approximately 42 mm. In some embodiments, the second predetermined distance 260 can be approximately 43 mm. In some embodiments, the second predetermined distance 260 can be approximately 44 mm. In some embodiments, the second predetermined distance 260 can be approximately 45 mm. Other sizes and / or values are also contemplated. In at least some embodiments, the second predetermined distance 260 can be less than the first predetermined distance 250.

[0085] In some embodiments, at least one set screw 170 can be configured to engage the body portion 182 of the distal hub 180, such as Figures 7 - 8As shown. In some embodiments, the method may include engaging at least one set screw 170 with a body portion 182 of the distal hub 180 to longitudinally and / or axially fix the distal hub 180 within the guide tube 160 at a second predetermined distance 260 from the proximal hub 190. 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, due to mechanical interference between the at least one set screw 170 and a helical ridge 184 of the distal hub 180, 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 the guide tube 160.

[0086] 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 helical guide 210 and / or a first collar 200 to a proximal handle 110 above 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 helical guide 240 and / or a second collar 230 to the proximal handle 110 above 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 housing to the first helical guide 210 distal to the first collar 200. The first helical guide 210 may be configured to rotate within the handle housing when the first collar 200 rotates relative to the handle housing and / or the guide tube 160.

[0087] In use, the system 100 can be used to deliver a replacement heart valve implant 50 to a treatment site. As discussed herein, the replacement heart valve implant 50 in a contracted configuration can be disposed within the valve sac 120 in a delivery configuration, as Figures 1 - 2 shown. In the delivery configuration, the proximal sac portion 122 may be longitudinally and / or axially spaced from the distal sac portion 124 by a first distance (e.g., Figures 1 - 2 ). At the treatment site, the proximal handle 110 can be used, actuated, and / or manipulated to convert the valve sac 120 to a deployment configuration, thereby releasing the replacement heart valve implant 50 and causing the replacement heart valve implant 50 to transition from a contracted configuration (e.g., Figures 1 - 2 ) to an expanded configuration (e.g., Figure 4 ). In the deployment configuration (e.g., Figure 4 ), the proximal sac portion 122 may be longitudinally and / or axially spaced from the distal sac portion 124 by a second distance (e.g., a first predetermined distance 250).

[0088] After deploying the replacement heart valve implant 50, the proximal handle 110 can be used, actuated, and / or manipulated to convert the valve sac 120 to the retracted configuration, as Figure 9 shown. After deploying the replacement heart valve implant 50, longitudinal and / or axial movement of the proximal hub 190 distally within and / or relative to the guide tube 160 can cause the proximal hub 190 to contact the distal hub 180 and apply an axial force to the distal hub 180 in the distal direction. Longitudinal and / or axial movement of the proximal hub 190 distally can be achieved and / or provided by rotation of the first collar 200 and / or the first helical guide 210, thereby pushing and / or driving the guide member 192 of the proximal hub 190 to move distally within the distal longitudinal slot 162. The distal hub 180 can serve as a hard stop for the distal longitudinal and / or axial movement of the proximal hub 190, such that the proximal sac portion 122 and the distal sac portion 124 are spaced apart by a third distance (e.g., Figure 9 ) in the retracted configuration. The third distance can be less than the first distance.

[0089] In some embodiments, the third distance can be about 2 mm. In some embodiments, the third distance can be about 2.5 mm. In some embodiments, the third distance can be about 3 mm. In some embodiments, the third distance can be about 3.5 mm. In some embodiments, the third distance can be about 4 mm. Other configurations and / or values are also contemplated.

[0090] Since the third distance is less than the first distance, the gap for pinching adjacent patient anatomy, other medical devices, etc. between the proximal sac portion 122 and the distal sac portion 124 can be smaller. However, it may be important and / or beneficial to avoid contact between the proximal sac portion 122 and the distal sac portion 124. Thus, the distal hub 180 serving as a hard stop for the proximal hub 190 can prevent the proximal sac portion 122 from colliding with, contacting, and / or axially overlapping the distal sac portion 124 when the valve sac 120 is converted to the retracted configuration, thereby preventing damage to the valve sac 120 and / or harm to the patient that may result from such damage during withdrawal of the system 100.

[0091] When the valve sac 120 is converted from the deployed configuration to the retracted configuration, when the replacement heart valve implant 50 is not within the valve sac 120, the proximal handle 110 and / or the first collar 200 (in combination with the first helical guide 210) can cause the proximal hub 190 to move relatively easily in the distal direction. To reduce the training requirements for the practitioner and / or improve the consistency of the results, when closing the valve sac 120 (e.g., converting the valve sac 120 from the deployed configuration to the retracted configuration), the distal hub 180 is used as a hard stop for the proximal hub 190, which cannot move or shift longitudinally and / or axially during use. The mechanical interference between at least one set screw 170 and the helical ridge 184 can prevent the distal hub 180 from moving longitudinally and / or axially, thereby enhancing the function of the distal hub 180 as a hard stop for the proximal hub 190. However, the assembly of the system 100 during the manufacturing process requires building at least some adjustability into the system 100 to accommodate tolerances and the like. The same combination of features (e.g., at least one set screw 170 and the helical ridge 184, and the mechanical interference therebetween) can both prevent the distal hub 180 from moving longitudinally and / or axially and allow the distal hub 180 to move longitudinally and / or axially relative to the guide tube 160 by rotation of the positioning sheath 150 and / or the distal hub 180 when the at least one set screw 170 is disengaged from the body portion 182 of the distal hub 180, thereby achieving adjustability of the distal hub 180 positioning.

[0092] The materials that can be used for the various components and various elements of the devices disclosed herein can include those commonly associated with medical devices and devices used in and / or related to medical devices. For simplicity, the following discussion is in terms of the system. However, this is not intended to limit the devices and methods described herein, as the discussion can be applied to other elements, components, parts, or devices disclosed herein, such as but not limited to replacement heart valve implants, proximal handles, valve sacs, inner shafts, outer sheaths, positioning sheaths, guide tubes, proximal hubs, distal hubs, at least one set screw, etc., and their elements or components.

[0093] In some embodiments, the system and its components can be made of metals, metal alloys, polymers (some examples are disclosed below), metal-polymer composites, ceramics, combinations thereof, etc., or other suitable materials.

[0094] Some examples of suitable polymers can include polytetrafluoroethylene (PTFE), ethylene-tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (e.g., )), polyether block ester, polyurethane, polypropylene (PP), polyvinyl chloride (PVC), polyether-ester (e.g., ), ether or ester-based copolymers (e.g., butene / poly(alkylene ether) phthalate and / or other polyester elastomers, such as ), polyamides (e.g., or )、elastic polyamide, block polyamide / ether, polyether block amide (PEBA, e.g., available under the trade name ), ethylene-vinyl acetate copolymer (EVA), silicone, polyethylene (PE), high-density polyethylene, low-density polyethylene, linear low-density polyethylene (e.g., ), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polypropylene terephthalate, polyethylene naphthalate (PEN), polyether ether ketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), poly(p-phenylene terephthalamide) (e.g., ), polysulfone, nylon, nylon-12 (such as ), perfluoro(propyl vinyl ether) (PFA), ethylene-vinyl alcohol, polyolefin, polystyrene, epoxy resin, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS 50A), polycarbonate, polyisobutylene (PIB), polyisobutylene polyurethane (PIBU), polyurethane-silicone copolymer (e.g., Elast- or ), ionomer, biocompatible polymer, other suitable materials, or their mixtures, combinations, copolymers, polymer / metal composites, etc. In some embodiments, the sheath can be blended with liquid crystal polymer (LCP). For example, the content of LCP in the mixture can be up to about 6%.

[0095] Some examples of suitable metals and metal alloys include stainless steel, such as 304V, 304L, and 316LV stainless steel; low-carbon 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 625, UNS: N06022, such as C- UNS: N10276, such as other alloys, etc.), nickel-copper alloys (e.g., UNS: N04400, such as 400, 400, 400, etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035, such as MP35- etc.), nickel-molybdenum alloys (e.g., UNS: N10665, such as ALLOY ) 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, etc.; cobalt-chromium alloys; cobalt-chromium-molybdenum alloys (e.g., UNS: R30003, such as etc.); platinum-rich stainless steels; titanium; platinum; palladium; gold; combinations thereof; or any other suitable material.

[0096] In some embodiments, some or all of the system and its components may be doped, made of radiopaque materials, or otherwise include radiopaque materials. Radiopaque materials are understood to be materials that can produce relatively bright images on a fluoroscope or other imaging techniques (such as ultrasound, etc.) during a medical procedure. Such relatively bright images help the user to determine the position of the system. Some examples of radiopaque materials may include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloys, polymeric materials filled with radiopaque fillers, etc. In addition, other radiopaque marker bands and / or coils may also be incorporated into the design of the system to achieve the same result.

[0097] In some embodiments, the system has a certain degree of magnetic resonance imaging (MRI) compatibility. For example, the system and its components or parts may be made of materials that do not cause significant distortion of the image and produce significant artifacts (such as gaps in the image). For example, certain ferromagnetic materials may not be suitable because they may produce artifacts in the MRI image. The system or parts thereof may also be made of materials that can be imaged by an MRI machine. Some materials that exhibit these properties include, for example, tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS: R44003, such as etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R44035, such as MP35- etc.), nitinol, etc., and other materials.

[0098] In some embodiments, the system may include a textile material. Some examples of suitable textile materials may include synthetic yarns, which may be flat, profiled, twisted, textured, preshrunk or non-preshrunk. Synthetic biocompatible yarns suitable for the present invention include, but are not limited to, polyesters, including polyethylene terephthalate (PET) polyester, polypropylene, polyethylene, polyurethane, polyolefins, polyvinyl chloride, polymethyl acetate, polyamides, naphthalenedicarboxylic acid derivatives, natural silk and polytetrafluoroethylene. In addition, at least one synthetic yarn may be a metallic yarn or a glass or ceramic yarn or fiber. Useful metallic yarns include those made of or containing stainless steel, platinum, gold, titanium, tantalum or nickel-cobalt-chromium-based alloys. The yarn may also include carbon, glass or ceramic fibers. In some embodiments, the yarn may be made of a thermoplastic material, including but not limited to polyester, polypropylene, polyethylene, polyurethane, polynaphthalene, polytetrafluoroethylene, etc. The yarn may be of the multifilament, monofilament or staple yarn type. The type and denier of the yarn selected may be chosen in such a way as to form a biocompatible system.

[0099] In some embodiments, the system and / or other elements disclosed herein may include and / or be treated with a suitable therapeutic agent. Some examples of suitable therapeutic agents may include antithrombotic agents (such as heparin, heparin derivatives, urokinase, and PPack (D-phenylalanyl-prolyl-arginine chloromethyl ketone)); anti-protein and / or antibacterial agents (such as 2-methacryloyloxyethyl phosphorylcholine (MPC) and its polymers or copolymers); antiproliferative agents (such as enoxaparin, angiotensin, 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 mesalazine); anti-tumor / antiproliferative / antimitotic agents (such as paclitaxel, 5-fluorouracil, cisplatin, vinblastine, vincristine, epothilones, endostatin, angiostatin, and thymidine kinase inhibitors); anesthetics (such as lidocaine, bupivacaine, and ropivacaine); anticoagulants (such as D-Phe-Pro-Arg chloromethyl ketone, RGD peptide-containing compounds, heparin, antithrombin compounds, platelet receptor antagonists, antithrombin antibodies, anti-platelet receptor antibodies, aspirin, prostaglandin inhibitors, platelet inhibitors, and tick antiplatelet peptides); vascular cell growth promoters (such as growth factor inhibitors, growth factor receptor antagonists, transcriptional activators, and translational promoters); vascular cell growth inhibitors (such as growth factor inhibitors, growth factor receptor antagonists, transcriptional inhibitors, translational inhibitors, replication inhibitors, inhibitory antibodies, antibodies against growth factors, bifunctional molecules composed of growth factors and cytotoxins, bifunctional molecules composed of antibodies and cytotoxins); immunosuppressants (such as the "olimus" series of drugs, rapamycin analogs, macrolide antibiotics, biolimus, everolimus, zotarolimus, temsirolimus, pimecrolimus, novolimus, miolimus, tacrolimus, sirolimus, pimecrolimus, etc.); cholesterol-lowering agents; vasodilators; and agents that interfere with endogenous vasoactive mechanisms).

[0100] It should be understood that the present disclosure is illustrative in many respects. Changes may be made in details, particularly in the shape, size, and arrangement of steps, without departing from the scope of the present disclosure. Where appropriate, this may include using any feature of one exemplary embodiment in other embodiments. Of course, the scope of the present disclosure is defined by the language of the appended claims.

Claims

1. A system for delivering a replacement heart valve implant, comprising: a proximal handle and a valve sac spaced apart from the proximal handle, the valve sac being configured to receive a replacement heart valve implant; an inner shaft extending distally from the proximal handle to the valve sac; an outer sheath coaxially disposed on the inner shaft and extending distally from the proximal handle to the valve sac; a positioning sheath coaxially disposed on the outer sheath and extending distally from the proximal handle to a distal end proximally spaced from the valve sac; a guide tube disposed within the proximal handle; and a distal hub fixedly connected to the proximal end of the positioning sheath, the distal hub being disposed within the guide tube and being selectively movable relative to the guide tube by rotation of the positioning sheath.

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

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

4. The system according to claim 3, wherein the at least one set screw includes two or more set screws.

5. The system according to any one of claims 1-4, further comprising a proximal hub fixedly connected to the proximal end of the outer sheath, the proximal hub being disposed within the guide tube and being selectively axially movable relative to the guide tube.

6. The system according to claim 5, wherein the proximal handle includes a first collar rotatably disposed around the guide tube; wherein rotation of the first collar around the guide tube causes the proximal hub to axially move within the guide tube.

7. The system according to claim 5, wherein the distal hub serves as a hard stop for axial movement of the proximal hub in the distal direction.

8. The system according to any one of claims 1-7, wherein the valve sac includes a proximal sac portion fixedly connected to a distal portion of the outer sheath and a distal sac portion fixedly connected to a distal portion of the inner shaft.

9. The system according to claim 8, wherein the proximal sac portion is configured to cover a first portion of the replacement heart valve implant, and the distal sac portion is configured to cover a second portion of the replacement heart valve implant so as to deliver the replacement heart valve implant percutaneously to a treatment site.

10. 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, wherein: an inner shaft extends through the guide tube to a distal sac portion of a valve sac spaced apart from the proximal handle, the valve sac being for receiving a replacement heart valve implant; the proximal hub is fixedly connected to the proximal end of an outer sheath, the outer sheath being coaxially disposed on the inner shaft and extending distally from the proximal handle to a proximal sac portion of the valve sac; the distal hub is fixedly connected to the proximal end of a positioning sheath, the positioning sheath being coaxially disposed on the outer sheath and extending distally from the proximal handle to a distal end proximally spaced from the valve sac; and At least one set screw is threadedly connected to the wall of the guide tube; Set a first predetermined distance between the proximal bladder portion and the distal bladder portion; Axially move the positioning sheath relative to the outer sheath to set a second predetermined distance between the proximal hub and the distal hub; and Engage the at least one set screw with the body portion of the distal hub to axially fix the distal hub within the guide tube such that it is spaced from the proximal hub by the second predetermined distance.

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

12. The method according to any one of claims 10-11, 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 according to 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. The method according to any one of claims 12-13, wherein the distal hub includes a proximal flange extending radially outward from the body portion and farther than the helical ridge, and a distal flange extending radially outward from the body portion and farther than the helical ridge.

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

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