Patent Application
20240307181
The disclosure relates generally to medical devices and more particularly to medical devices that are adapted for implanting stents and medical devices including a stent component.
A wide variety of intracorporeal medical devices have been developed for medical use including, artificial heart valves for repair or replacement of diseased heart valves. The artificial heart valves need to be precisely aligned relative to a native valve annulus when implanted. Of the known medical devices and methods, each has certain advantages and disadvantages. There is an ongoing need to provide alternative medical devices as well as alternative methods for manufacturing and using medical devices.
In one example, an implant delivery system for delivering a replacement heart valve implant to a native heart valve may comprise an elongate shaft assembly including an implant holding portion comprising a proximal sheath and a distal sheath. The implant holding portion may be configured to constrain a replacement heart valve implant in a radially collapsed configuration. The elongate shaft assembly may comprise a plurality of longitudinal marker elements configured to be visible under fluoroscopy with an imaging device. The plurality of longitudinal marker elements may be configured to rotationally align commissure posts of the replacement heart valve implant with native valve commissures of the native heart valve under fluoroscopy with the imaging device when the replacement heart valve implant is shifted to a radially expanded configuration within the native heart valve.
In addition or alternatively to any example described herein, the plurality of longitudinal marker elements is oriented parallel to a central longitudinal axis of the elongate shaft assembly.
In addition or alternatively to any example described herein, the plurality of longitudinal marker elements is spaced radially outward from an inner shaft of the elongate shaft assembly.
In addition or alternatively to any example described herein, the plurality of longitudinal marker elements is equally spaced apart from each other circumferentially about a central longitudinal axis of the elongate shaft assembly.
In addition or alternatively to any example described herein, the elongate shaft assembly includes a stent holder configured to engage an expandable framework of the replacement heart valve implant in the radially collapsed configuration.
In addition or alternatively to any example described herein, the plurality of longitudinal marker elements comprises a plurality of fingers extending distally from a body of the stent holder.
In addition or alternatively to any example described herein, the plurality of fingers includes exactly three fingers.
In addition or alternatively to any example described herein, the elongate shaft assembly includes at least one fluoroscopically transparent component disposed radially outward of the plurality of longitudinal marker elements and radially inward of the distal sheath.
In addition or alternatively to any example described herein, the plurality of longitudinal marker elements is only visible under fluoroscopy.
In addition or alternatively to any example described herein, the plurality of longitudinal marker elements is longitudinally spaced apart from the replacement heart valve implant in the radially collapsed configuration.
In addition or alternatively to any example described herein, the plurality of longitudinal marker elements is disposed distally of the replacement heart valve implant when the replacement heart valve implant is constrained in the radially collapsed configuration within the implant holding portion.
In addition or alternatively to any example described herein, an implant delivery system for delivering a replacement heart valve implant to a native heart valve may comprise an elongate shaft assembly including an outer tubular member, an inner shaft, and an implant holding portion. The implant holding portion may be configured to constrain a replacement heart valve implant in a radially collapsed configuration. The elongate shaft assembly may comprise a stent holder configured to engage a distal portion of an expandable framework of the replacement heart valve implant when the replacement heart valve implant is constrained within the implant holding portion of the implant delivery system, and a plurality of longitudinal marker elements extending distally from a distal end of the stent holder, the plurality of longitudinal marker elements being configured to be visible under fluoroscopy with an imaging device. The plurality of longitudinal marker elements may include a first longitudinal marker element, a second longitudinal marker element, and a third longitudinal marker element equally spaced apart from each other circumferentially around a central longitudinal axis of the elongate shaft assembly. The plurality of longitudinal marker elements may be configured to rotationally align commissure posts of the replacement heart valve implant with native valve commissures of the native heart valve under fluoroscopy with the imaging device when the replacement heart valve implant is shifted to a radially expanded configuration within the native heart valve.
In addition or alternatively to any example described herein, the implant holding portion includes a proximal sheath disposed about the inner shaft of the elongate shaft assembly and a distal sheath disposed about the inner shaft of the elongate shaft assembly. The proximal sheath is fixedly attached to the outer tubular member and the distal sheath is fixedly attached to the inner shaft.
In addition or alternatively to any example described herein, the stent holder is fixedly attached to an intermediate tubular member disposed radially inward of the outer tubular member and radially outward of the inner shaft. The inner shaft and the outer tubular member are each axially translatable relative to the intermediate tubular member independently of each other.
In addition or alternatively to any example described herein, a method of delivering a replacement heart valve implant to a native heart valve may comprise: configuring an imaging device to produce a 3-cusp view of the native heart valve in a first position and a cusp overlap view of the native heart valve in a second position; advancing an implant delivery system to a position adjacent the native heart valve, wherein the replacement heart valve implant is constrained within an implant holding portion of the implant delivery system; imaging the implant delivery system adjacent the native heart valve with the imaging device to determine an initial orientation of the replacement heart valve implant relative to the native heart valve via relative positioning of a plurality of longitudinal marker elements of the implant delivery system within the native heart valve; rotating the implant delivery system in situ to position the replacement heart valve implant in a desired final orientation by aligning the plurality of longitudinal marker elements with native valve commissures of the native heart valve; and deploying the replacement heart valve implant within the native heart valve with commissure posts of the replacement heart valve implant rotationally aligned with the native valve commissures of the native heart valve.
In addition or alternatively to any example described herein, imaging the implant delivery system adjacent the native heart valve to determine the initial orientation of the replacement heart valve implant relative to the native heart valve comprises: imaging the implant delivery system and the native heart valve in the 3-cusp view; and switching to the cusp overlap view to determine a direction of rotation of the implant delivery system required to position the replacement heart valve implant in the desired final orientation with as little rotation as possible.
In addition or alternatively to any example described herein, the method may further comprise switching back to the 3-cusp view prior to deploying the replacement heart valve implant.
In addition or alternatively to any example described herein, the implant delivery system includes an elongate shaft assembly including the implant holding portion and a stent holder configured to engage an expandable framework of the replacement heart valve implant when the replacement heart valve implant is constrained within an implant holding portion of the implant delivery system. The stent holder includes the plurality of longitudinal marker elements.
In addition or alternatively to any example described herein, rotating the implant delivery system in situ includes rotating the implant delivery system 60 degrees or less about a central longitudinal axis of the elongate shaft assembly of the implant delivery system.
In addition or alternatively to any example described herein, in the desired final orientation, a single longitudinal marker element of the plurality of longitudinal marker elements is positioned farther away from a non-coronary cusp of the native heart valve than other marker elements of the plurality of longitudinal marker elements in the cusp overlap view.
The above summary of some embodiments, aspects, and/or examples is not intended to describe each disclosed embodiment or every implementation of the present disclosure. The figures and detailed description which follow more particularly exemplify these embodiments.
The disclosure may be more completely understood in consideration of the following detailed description in connection with the accompanying drawings, in which:
While aspects of the 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 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 disclosure.
The following description should be read with reference to the drawings, which are not necessarily to scale, wherein like reference numerals indicate like elements throughout the several views. The detailed description and drawings are intended to illustrate but not limit the disclosure. Those skilled in the art will recognize that the various elements described and/or shown may be arranged in various combinations and configurations without departing from the scope of the disclosure. The detailed description and drawings illustrate example embodiments of the disclosure.
For the following defined terms, these definitions shall be applied, unless a different definition is given in the claims or elsewhere in this specification.
All numeric values are herein assumed to be modified by the term “about,” whether or not explicitly indicated. The term “about”, in the context of numeric values, generally refers to a range of numbers that one of skill in the art would consider equivalent to the recited value (e.g., having the same function or result). In many instances, the term “about” may include numbers that are rounded to the nearest significant figure. Other uses of the term “about” (e.g., in a context other than numeric values) may be assumed to have their ordinary and customary definition(s), as understood from and consistent with the context of the specification, unless otherwise specified.
The recitation of numerical ranges by endpoints includes 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).
Although some suitable dimensions, ranges, and/or values pertaining to various components, features and/or specifications are disclosed, one of skill in the art, incited by the present disclosure, would understand desired dimensions, ranges, and/or values may deviate from those expressly disclosed.
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 employed in its sense including “and/or” unless the content clearly dictates otherwise. It is to be noted that to facilitate understanding, certain features of the disclosure may be described in the singular, even though those features may be plural or recurring within the disclosed embodiment(s). Each instance of the features may include and/or be encompassed by the singular disclosure(s), unless expressly stated to the contrary. For example, a reference to one feature may be equally referred to all instances and quantities beyond one of said feature unless clearly stated to the contrary. As such, it will be understood that the following discussion may apply equally to any and/or all components for which there are more than one within the device, etc. unless explicitly stated to the contrary.
Relative terms such as “proximal”, “distal”, “advance”, “retract”, variants thereof, and the like, may be generally considered with respect to the positioning, direction, and/or operation of various elements relative to a user/operator/manipulator of the device, wherein “proximal” and “retract” indicate or refer to closer to or toward the user and “distal” and “advance” indicate or refer to farther from or away from the user. In some instances, the terms “proximal” and “distal” may be arbitrarily assigned to facilitate understanding of the disclosure, and such instances will be readily apparent to the skilled artisan. Other relative terms, such as “upstream”, “downstream”, “inflow”, and “outflow” refer to a direction of fluid flow within a lumen, such as a body lumen, a blood vessel, or within a device. Still other relative terms, such as “axial”, “circumferential”, “longitudinal”, “lateral”, “radial”, etc. and/or variants thereof generally refer to direction and/or orientation relative to a central longitudinal axis of the disclosed structure or device.
The term “extent” may be understood to mean the greatest measurement of a stated or identified dimension, unless the extent or dimension in question is preceded by or identified as a “minimum”, which may be understood to mean the smallest measurement of the stated or identified dimension. For example, “outer extent” may be understood to mean an outer dimension, “radial extent” may be understood to mean a radial dimension, “longitudinal extent” may be understood to mean a longitudinal dimension, etc. Each instance of an “extent” may be different (e.g., axial, longitudinal, lateral, radial, circumferential, etc.) and will be apparent to the skilled person from the context of the individual usage. Generally, an “extent” may be considered a greatest possible dimension measured according to the intended usage, while a “minimum extent” may be considered a smallest possible dimension measured according to the intended usage. In some instances, an “extent” may generally be measured orthogonally within a plane and/or cross-section, but may be, as will be apparent from the particular context, measured differently—such as, but not limited to, angularly, radially, circumferentially (e.g., along an arc), etc.
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. A monolithic and/or unitary element shall exclude structure and/or features made by assembling or otherwise joining multiple discrete structures or elements together.
It is noted that references in the specification to “an embodiment”, “some embodiments”, “other embodiments”, etc., indicate that the embodiment(s) described may include a particular feature, structure, or characteristic, but every embodiment may not necessarily include the particular feature, structure, or characteristic. Moreover, such phrases are not necessarily referring to the same embodiment. Further, when a particular feature, structure, or characteristic is described in connection with an embodiment, it would be within the knowledge of one skilled in the art to implement the particular feature, structure, or characteristic in connection with other embodiments, whether or not explicitly described, unless clearly stated to the contrary. That is, the various individual elements described below, even if not explicitly shown in a particular combination, are nevertheless contemplated as being combinable or arrangeable with each other to form other additional embodiments or to complement and/or enrich the described embodiment(s), as would be understood by one of ordinary skill in the art.
For the purpose of 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 differentiate between various described and/or claimed features. It is to be understood that the numerical nomenclature is not intended to be limiting and is exemplary only. In some embodiments, alterations of and deviations from previously used numerical nomenclature may be made in the interest of brevity and clarity. 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 a different feature may be referred to as the “first” element. The meaning and/or designation in each instance will be apparent to the skilled practitioner.
Additionally, it should be noted that in any given figure, some features may not be shown, or may be shown schematically, for clarity and/or simplicity. Additional details regarding some components and/or method steps may be illustrated in other figures in greater detail. The devices and/or methods disclosed herein may provide a number of desirable features and benefits as described in more detail below.
The replacement heart valve implant 100 may include an expandable framework 110 defining a central lumen. In some embodiments, the expandable framework 110 may have a substantially circular cross-section. In some embodiments, the expandable framework 110 can have a non-circular (e.g., D-shaped, elliptical, etc.) cross-section. Some suitable but non-limiting examples of materials that may be used to form the expandable framework 110, including but not limited to metals and metal alloys, composites, ceramics, polymers, and the like, are described below. The replacement heart valve implant 100 and/or the expandable framework 110 may be configured to shift between a radially collapsed configuration and a radially expanded configuration. In some embodiments, the expandable framework 110 may be self-expanding. In some embodiments, the expandable framework 110 may be self-biased toward the radially expanded configuration. In some embodiments, the expandable framework 110 may be mechanically expandable. In some embodiments, the expandable framework 110 may be balloon expandable. Other configurations, including combinations thereof, are also contemplated.
In some embodiments, the expandable framework 110 may define a lower crown 112 proximate and/or at the inflow end, an upper crown 114 proximate and/or at the outflow end, and a plurality of stabilization arches 116 extending downstream from the outflow end. In some embodiments, the plurality of stabilization arches 116 may extend downstream of and/or away from the upper crown 114 in a direction opposite the lower crown 112. In some embodiments, the upper crown 114 may be disposed longitudinally and/or axially between the lower crown 112 and the plurality of stabilization arches 116. The expandable framework 110 may define a central lumen extending therethrough.
In some embodiments, the replacement heart valve implant 100 may include a proximal portion and a distal portion. In some embodiments, orientation of the replacement heart valve implant 100 may be related to an implant delivery system 30 (e.g.,
In some embodiments, the replacement heart valve implant 100 may include a plurality of valve leaflets 120 disposed within the central lumen. The plurality of valve leaflets 120 may be coupled, secured, and/or fixedly attached to the expandable framework 110 at a plurality of posts 122 to form and/or define a plurality of commissures. The plurality of valve leaflets 120 may be configured to shift between an open position and a closed position. The plurality of valve leaflets 120 may be configured to substantially restrict fluid flow through the replacement heart valve implant 100 in the closed position. The plurality of valve leaflets 120 may move apart from each other and/or radially outward within the central lumen in the open position to permit fluid flow through the replacement heart valve implant 100 and/or the central lumen.
In some embodiments, the plurality of valve leaflets 120 may be comprised of a polymer, such as a thermoplastic polymer. In some embodiments, the plurality of valve leaflets 120 may include at least 50 percent by weight of a polymer. In some embodiments, the plurality of valve leaflets 120 may be formed from bovine pericardial or other living tissue. Other configurations and/or materials are also contemplated.
In some embodiments, the replacement heart valve implant 100 may include an inner skirt disposed on and/or extending along an inner surface of the expandable framework 110. In at least some embodiments, the inner skirt may be fixedly attached to the expandable framework 110. The inner skirt may direct fluid, such as blood, flowing through the replacement heart valve implant 100 toward the plurality of valve leaflets 120. In at least some embodiments, the inner skirt may be fixedly attached to and/or integrally formed with the plurality of valve leaflets 120. The inner skirt may ensure the fluid flows through the central lumen of the replacement heart valve implant 100 and does not flow around the plurality of valve leaflets 120 when they are in the closed position.
In some embodiments, the replacement heart valve implant 100 may include an outer skirt disposed on and/or extending along an outer surface of the expandable framework 110. In some embodiments, the outer skirt may be disposed at and/or adjacent the lower crown. The outer skirt may ensure the fluid flows through the replacement heart valve implant 100 and does not flow around the replacement heart valve implant 100 (e.g., between the expandable framework 110 and the vessel wall).
In some embodiments, the inner skirt and/or the outer skirt may include a polymer, and/or may include at least 50 percent by weight of a polymer. In some embodiments, the inner skirt and/or the outer skirt may be substantially impervious to fluid. In some embodiments, the inner skirt and/or the outer skirt may be formed from a thin tissue (e.g., bovine pericardial, etc.), a coated fabric material, or a nonporous and/or impermeable fabric 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 the outer skirt including but not limited to polymers, composites, and the like, are described below.
In some embodiments, the inner skirt and/or the outer skirt may seal one of, some of, a plurality of, or each of a plurality of interstices formed in the expandable framework 110. In at least some embodiments, sealing the interstices may be considered to prevent fluid from flowing through the interstices of the expandable framework 110. In some embodiments, the inner skirt and/or the outer skirt may be attached to the expandable framework 110 using one or more methods including but not limited to tying with sutures or filaments, adhesive bonding, melt bonding, embedding or over molding, welding, etc.
In some embodiments, the expandable framework 110 and/or the replacement heart valve implant 100 may have an outer extent of about 23 millimeters (mm), about 25 mm, about 27 mm, about 30 mm, etc. in an unconstrained configuration (e.g., in the radially expanded configuration). In some embodiments, the expandable framework 110 and/or the replacement heart valve implant 100 may have an outer extent of about 10 mm, about 9 mm, about 8 mm, about 7 mm, about 6 mm, etc. in the radially collapsed configuration. Other configurations are also contemplated.
The implant delivery system 30 may include a handle 40 and an elongate shaft assembly 50 extending distally from the handle 40. The handle 40 may include a first end 42 and a second end 44 opposite the first end 42. The elongate shaft assembly 50 may extend distally from the second end 44 of the handle 40. The handle 40 may include one or more rotatable knobs. In some embodiments, the one or more rotatable knobs may include a first rotatable knob and a second rotatable knob. In at least some embodiments, the first rotatable knob and/or the second rotatable knob may be configured to rotate about a central longitudinal axis of the implant delivery system 30 and/or the handle 40.
In some embodiments, a distal portion of the implant delivery system 30 and/or the elongate shaft assembly 50 may include an implant holding portion 60 configured to engage with and/or constrain the replacement heart valve implant 100 and/or the expandable framework 110 in the radially collapsed configuration. The elongate shaft assembly 50 may include an outer tubular member 52 extending distally from the handle 40 and an inner shaft 54 (e.g.,
In some embodiments, the inner shaft 54 may be slidably disposed within a lumen of the outer tubular member 52. In some embodiments, the elongate shaft assembly 50 may include an intermediate tubular member 56 disposed within and/or radially inward of the outer tubular member 52 and about and/or radially outward of the inner shaft 54. In at least some embodiments, the inner shaft 54 and the outer tubular member 52 are each axially translatable relative to the intermediate tubular member 56 independently of each other. For example, the inner shaft 54 may be translated relative to the intermediate tubular member 56 without translating the outer tubular member 52 relative to the intermediate tubular member 56, and vice versa.
In some embodiments, the proximal sheath 62 may be fixedly attached to the outer tubular member 52. In some embodiments, the proximal sheath 62 may be fixedly attached to and/or may extend distally from a distal end of the outer tubular member 52. In some embodiments, the distal sheath 64 and/or the distal tip 58 may be fixedly attached to the inner shaft 54. In some embodiments, the distal sheath 64 may be fixedly attached to the distal tip 58. In some embodiments, the distal sheath 64 may extend proximally from the distal tip 58. In some embodiments, the inner shaft 54 may include and/or at least partially define a guidewire lumen extending therethrough. In some embodiments, the guidewire lumen may extend through the handle 40.
In some embodiments, the handle 40 may be configured to manipulate and/or translate the proximal sheath 62 and/or the distal sheath 64 relative to each other using the first rotatable knob and/or the second rotatable knob. In some embodiments, the handle 40 may be configured to manipulate and/or translate the inner shaft 54 and/or the distal sheath 64 relative to the elongate shaft assembly 50, the outer tubular member 52, the intermediate tubular member 56, and/or the proximal sheath 62. In some embodiments, the handle 40 may be configured to manipulate and/or translate the outer tubular member 52 and/or the proximal sheath 62 relative to the elongate shaft assembly 50, the inner shaft 54, the intermediate tubular member 56, and/or the distal sheath 64.
During delivery of the replacement heart valve implant 100 to a treatment site (e.g., the native heart valve, the aortic valve 12, etc.), the replacement heart valve implant 100 may be disposed at least partially within the proximal sheath 62 and/or the distal sheath 64 in the radially collapsed configuration in a closed configuration of the implant holding portion 60. In some embodiments, the proximal sheath 62 and/or the distal sheath 64 may collectively define the implant holding portion 60 of the implant delivery system 30. In some embodiments, the implant holding portion 60 may be configured to constrain the replacement heart valve implant 100 in the radially collapsed configuration when the implant holding portion 60 is in the closed configuration. In some embodiments, the replacement heart valve implant 100 may be releasably coupled to the intermediate tubular member 56 and/or a stent holder 70 when the replacement heart valve implant 100 is constrained within the implant holding portion 60 of the implant delivery system 30 in the radially collapsed configuration.
In some embodiments, the proximal sheath 62 may be configured to cover the proximal portion of the replacement heart valve implant 100 in the radially collapsed configuration when the implant holding portion 60 is in the closed configuration, and the distal sheath 64 may be configured to cover the distal portion of the replacement heart valve implant 100 in the radially collapsed configuration when the implant holding portion 60 is in the closed configuration. In some embodiments, the replacement heart valve implant 100 and/or the expandable framework 110 may be constrained in the radially collapsed configuration by the proximal sheath 62 and the distal sheath 64 in the closed configuration of the implant holding portion 60. In some embodiments, the proximal sheath 62 may be disposed adjacent to the distal sheath 64 in the closed configuration. In some embodiments, the proximal sheath 62 may abut the distal sheath 64 in the closed configuration. In some embodiments, the proximal sheath 62 may be axially spaced apart from the distal sheath 64 in the closed configuration. In some embodiments, the proximal sheath 62 may be axially spaced apart from the distal sheath 64 in the closed configuration by less than 20% of an overall length of the replacement heart valve implant 100 and/or the expandable framework 110. In some embodiments, the proximal sheath 62 may be axially spaced apart from the distal sheath 64 in the closed configuration by less than 15% of an overall length of the replacement heart valve implant 100 and/or the expandable framework 110. In some embodiments, the proximal sheath 62 may be axially spaced apart from the distal sheath 64 in the closed configuration by less than 10% of an overall length of the replacement heart valve implant 100 and/or the expandable framework 110. In some embodiments, the proximal sheath 62 may be axially spaced apart from the distal sheath 64 in the closed configuration by less than 5% of an overall length of the replacement heart valve implant 100 and/or the expandable framework 110. Other configurations are also contemplated.
In some embodiments, the implant holding portion 60 and/or the elongate shaft assembly 50 may include the stent holder 70, which is shown in more detail in
The implant delivery system 30 and/or the elongate shaft assembly 50 may include a primary visual indicator 68 configured and/or adapted to be visible under fluoroscopy with an imaging device. Other imaging means suitable for use with transcatheter surgical procedures are also contemplated. The implant delivery system 30 and/or the primary visual indicator 68 may be configured to cooperate with the imaging device to position the replacement heart valve implant 100 at a desired insertion depth within the native heart valve (e.g., the aortic valve 12).
In use, the implant delivery system 30 may be advanced percutaneously through the vasculature to a position adjacent to the treatment site (e.g., the native valve annulus). For example, the implant delivery system 30 may be advanced through the vasculature and across the aortic arch 22 to a position adjacent to the native heart valve (e.g., the aortic valve 12). Alternative approaches to treat a defective aortic valve and/or other heart valve(s) are also contemplated with the implant delivery system 30.
The desired insertion depth may be selected to maximize radially outward force of the expandable framework 110 within the native heart valve (e.g., the aortic valve 12). Positioning the replacement heart valve implant 100 at the desired insertion depth and/or within a maximum tolerance from the desired insertion depth, the replacement heart valve implant 100 and/or the expandable framework 110 may exhibit optimal arching within the native heart valve (e.g., the aortic valve 12) and thereby prevent migration of the replacement heart valve implant 100 and/or the expandable framework 110 downstream (or upstream).
Positioning the replacement heart valve implant 100 and/or the expandable framework 110 within the native heart valve (e.g., the aortic valve 12) may be accomplished by locating the primary visual indicator 68 relative to the native heart valve (e.g., the aortic valve 12). During visualization, the native heart valve (e.g., the aortic valve 12) may be identified and/or visualized under fluoroscopy using known means and/or methods, such as contrast injection.
As seen in
In some embodiments, the implant delivery system 30 and/or the elongate shaft assembly 50 may include the stent holder 70 configured to engage the expandable framework 110 of the replacement heart valve implant 100 in the radially collapsed configuration and/or when the replacement heart valve implant 100 is constrained within the implant holding portion 60 of the implant delivery system 30. The stent holder 70 is shown in more detail in
In some embodiments, an outermost radial extent of the first end portion 72 of the stent holder 70 may be disposed proximate a distal end of the first end portion 72 of the stent holder 70. In some embodiments, the first end portion 72 of the stent holder 70 may be tapered radially inward in a proximal direction from the outermost radial extent of the stent holder 70. In some embodiments, the stent holder 70 may include a lumen extending longitudinally and/or axially therethrough. In at least some embodiments, at least a portion of the elongate shaft assembly 50 may extend longitudinally and/or axially through the lumen of the stent holder 70.
The first end portion 72 may be configured and/or adapted to engage the expandable framework 110 of the replacement heart valve implant 100 in the radially collapsed configuration and/or when the replacement heart valve implant 100 is constrained within the implant holding portion 60 of the implant delivery system 30. In some embodiments, the first end portion 72 may include at least one projection 73 configured and/or adapted to engage the expandable framework 110 of the replacement heart valve implant 100 in the radially collapsed configuration and/or when the replacement heart valve implant 100 is constrained within the implant holding portion 60 of the implant delivery system 30.
In some embodiments, at least one projection 73 may be configured and/or adapted to engage a distal portion and/or the lower crown 112 of the expandable framework 110 of the replacement heart valve implant 100 in the radially collapsed configuration and/or when the replacement heart valve implant 100 is constrained within the implant holding portion 60 of the implant delivery system 30. In some embodiments, the at least one projection 73 may extend radially outward from the first end portion 72 of the stent holder 70. In some embodiments, the at least one projection 73 may extend radially outward through the expandable framework 110 of the replacement heart valve implant 100 in the radially collapsed configuration and/or when the replacement heart valve implant 100 is constrained within the implant holding portion 60 of the implant delivery system 30.
The elongate shaft assembly 50 may comprise a plurality of longitudinal marker elements 80 configured to be visible under fluoroscopy with an imaging device. In some embodiments, the plurality of longitudinal marker elements 80 may include two longitudinal marker elements, three longitudinal marker elements, etc. In some embodiments, the plurality of longitudinal marker elements 80 may extend distally from the body 74 of the stent holder 70. In some embodiments, the plurality of longitudinal marker elements 80 may extend distally from a distal end of the body 74. In some embodiments, the second end portion 76 may include the plurality of longitudinal marker elements 80.
In some embodiments, the plurality of longitudinal marker elements 80 may be oriented parallel to a central longitudinal axis of the elongate shaft assembly 50. In some embodiments, the plurality of longitudinal marker elements 80 may be spaced radially outward from the inner shaft 54 of the elongate shaft assembly 50. In some embodiments, the plurality of longitudinal marker elements 80 may be equally spaced apart from each other circumferentially about the central longitudinal axis of the elongate shaft assembly 50.
In one example configuration, the plurality of longitudinal marker elements 80 may include a first longitudinal marker element 81, a second longitudinal marker element 82, and a third longitudinal marker element 83. In some embodiments, the first longitudinal marker element 81, the second longitudinal marker element 82, and the third longitudinal marker element 83 may be oriented parallel to a central longitudinal axis of the elongate shaft assembly 50. In some embodiments, the first longitudinal marker element 81, the second longitudinal marker element 82, and the third longitudinal marker element 83 may be spaced radially outward from the inner shaft 54 of the elongate shaft assembly 50. In some embodiments, the first longitudinal marker element 81, the second longitudinal marker element 82, and the third longitudinal marker element 83 may be equally spaced apart from each other circumferentially about the central longitudinal axis of the elongate shaft assembly 50. For example, the first longitudinal marker element 81, the second longitudinal marker element 82, and the third longitudinal marker element 83 may be arranged at 120 degrees apart from each other around the central longitudinal axis, and/or the first longitudinal marker element 81, the second longitudinal marker element 82, and the third longitudinal marker element 83 may be positioned and/or disposed on a theoretical circle around the central longitudinal axis and circumferentially spaced apart by an arc length equal to one third of a circumference of the theoretical circle.
In some embodiments, the plurality of longitudinal marker elements 80 may comprise a plurality of fingers extending distally from the body 74 of the stent holder 70. In some embodiments, the plurality of fingers may include two fingers, three fingers, four fingers, etc. In one example, the plurality of fingers may include exactly three fingers.
In some alternative configurations, the plurality of longitudinal marker elements 80 may be embedded within and/or fixedly attached to the elongate shaft assembly 50. In some further alternative configurations, the plurality of longitudinal marker elements 80 may extend from the first end portion 72 of the stent holder 70. Other configurations are also contemplated.
In some embodiments, the plurality of longitudinal marker elements 80 and/or the plurality of fingers may extend away from the body 74 of the stent holder 70. In some embodiments, the plurality of longitudinal marker elements 80 and/or the plurality of fingers may be longitudinally and/or axially aligned with the at least one projection 73. In some embodiments, the plurality of longitudinal marker elements 80 and/or the plurality of fingers may be configured and/or adapted to align with the plurality of posts 122 and/or the plurality of commissures of the replacement heart valve implant 100. In some embodiments, the plurality of longitudinal marker elements 80 and/or the plurality of fingers may be configured and/or adapted to be visible under fluoroscopy. In some embodiments, the plurality of longitudinal marker elements 80 and/or the plurality of fingers may be configured and/or adapted to align the implant delivery system 30, the stent holder 70, and/or the plurality of posts 122 and the plurality of the commissures of the replacement heart valve implant 100 with the native valve commissures 18 of the native heart valve (e.g., the aortic valve 12) under fluoroscopy. In some embodiments, the plurality of longitudinal marker elements 80 and/or the plurality of fingers may be configured and/or adapted to rotationally align the implant delivery system 30, the stent holder 70, and/or the plurality of posts 122 and the plurality of commissures of the replacement heart valve implant 100 with the native valve commissures 18 of the native heart valve (e.g., the aortic valve 12) under fluoroscopy.
Returning to
The implant delivery system 30 and/or the elongate shaft assembly 50 may include a cage 78 disposed radially outward of and/or extending radially outward from the elongate shaft assembly 50, the distal cap 77, and/or the stent holder 70. In some embodiments, the cage 78 may be configured to substantially center the distal sheath 64 over and/or around the elongate shaft assembly 50 as the distal sheath 64 is moved from an open configuration to the closed configuration. Other configurations are also contemplated.
The cage 78 may be positioned radially outward of and axially overlapping the plurality of longitudinal marker elements 80. In some embodiments, the cage 78 may be positioned radially outward of and axially overlapping the body 74 of the stent holder 70. In some embodiments, the cage 78 may be positioned radially outward of and axially overlapping a portion of the distal cap 77. In some embodiments, the distal cap 77 may include a flanged portion extending radially outward from the central longitudinal axis of the elongate shaft assembly 50. The flanged portion of the distal cap 77 and the first end portion 72 of the stent holder 70 may cooperate to axially retain the cage 78 in place over the second end portion 76 of the stent holder 70 and/or the plurality of longitudinal marker elements 80.
In at least some embodiments, the distal cap 77 and the cage 78 may be formed from a fluoroscopically transparent (or fluoroscopically translucent) material such that the plurality of longitudinal marker elements 80 is clearly visible under fluoroscopy. In some embodiments, the distal cap 77 and the cage 78 may be formed from a polymeric material. In some embodiments, the elongate shaft assembly 50 may include at least one fluoroscopically transparent (or fluoroscopically translucent) component disposed radially outward of the plurality of longitudinal marker elements 80 and radially inward of the distal sheath 64 of the implant holding portion 60. In some embodiments, the plurality of longitudinal marker elements 80 may not be visible to the naked eye, even if the replacement heart valve implant 100 is not present and the implant holding portion 60 is in the open configuration (e.g., the distal sheath 64 has been translated distally relative to the intermediate tubular member 56 and/or the stent holder 70). In some embodiments, the plurality of longitudinal marker elements 80 is only visible under fluoroscopy.
In some embodiments, the implant delivery system 30 and/or the implant holding portion may include an atraumatic transition shield 79. The atraumatic transition shield 79 may be disposed adjacent the stent holder 70. In some embodiments, the atraumatic transition shield 79 may be disposed between the stent holder 70 and the handle 40. In some embodiments, the atraumatic transition shield 79 may be disposed proximal the stent holder 70. In some embodiments, the atraumatic transition shield 79 may be disposed at and/or adjacent the first end portion 72 of the stent holder 70. In some embodiments, the atraumatic transition shield 79 may axially overlap the first end portion 72 of the stent holder 70. In some embodiments, the atraumatic transition shield 79 may be disposed radially outward of at least a portion of the first end portion 72 of the stent holder 70. In some embodiments, the atraumatic transition shield 79 may be tapered radially inward in the proximal direction and/or toward the handle 40. The atraumatic transition shield 79 may be configured to prevent the replacement heart valve implant 100, the expandable framework 110, the plurality of valve leaflets 120, etc. from catching on the stent holder 70 as the implant delivery system 30 is withdrawn after deploying the replacement heart valve implant 100.
In use, after advancing and/or navigating the implant delivery system 30 and/or the implant holding portion 60 to the treatment site (over a guidewire, for example), the proximal sheath 62 and/or the distal sheath 64 may be axially translated relative to each other to shift the implant holding portion 60 to the open configuration. When unconstrained by the implant holding portion 60, the replacement heart valve implant 100 and/or the expandable framework 110 may be configured to shift from the radially collapsed configuration to the radially expanded configuration. Shifting the replacement heart valve implant 100 and/or the expandable framework 110 toward the radially expanded configuration after axially translating the proximal sheath 62 and/or the distal sheath 64 away from each other and/or the stent holder 70 may permit the replacement heart valve implant 100 and/or the expandable framework 110 to decouple and/or detach from the implant delivery system 30. Some suitable but non-limiting materials for the implant delivery system 30, the handle 40, the elongate shaft assembly 50, the proximal sheath 62, the distal sheath 64, the primary visual indicator 68, the atraumatic transition shield 79, and/or components or elements thereof, for example metallic materials and/or polymeric materials, are described below.
In at least some interventions, the replacement heart valve implant 100 may be deployed within the native heart valve (e.g., the native heart valve is left in place and not excised). Alternatively, the native heart valve may be removed (such as through valvuloplasty, for example) and the replacement heart valve implant 100 may be deployed in its place as a replacement.
As seen in
The vast majority of the replacement heart valve implant 100 and/or the expandable framework 110 may be disposed proximal of the stent holder 70 when constrained in the radially collapsed configuration within the implant holding portion 60. The plurality of longitudinal marker elements 80 may be longitudinally spaced apart from the replacement heart valve implant 100 and/or the expandable framework 110 when the replacement heart valve implant 100 is constrained in the radially collapsed configuration within the implant holding portion 60 of the implant delivery system 30, as shown in
As shown in the fluoroscopic image of
When delivering the replacement heart valve implant 100 to the native heart valve (e.g., the aortic valve 12), fluoroscopy is used to visualize the procedure and is well known in the art. In some procedures, an imaging device may be configured to use two different views—the 3-cusp view and the cusp overlap view—and those views would be understood by the skilled artisan. In some embodiments, the 3-cusp view is used initially, and when a satisfactory positioning is seen in the 3-cusp view, the imaging device is switched to the cusp overlap view to verify the orientation and/or positioning of the replacement heart valve implant 100, the plurality of posts 122, and the plurality of commissures with respect to the native heart valve (e.g., the aortic valve 12) and the native valve commissures 18. In some embodiments, the imaging device may be switched between the 3-cusp view and the cusp overlap view multiple times during a procedure.
The 3-cusp view is illustrated schematically in
As may be seen when comparing
Accordingly, once the plurality of longitudinal marker elements 80 are seen generally aligned with the native valve commissures 18 in the 3-cusp view, as shown in
If the replacement heart valve implant 100 is positioned correctly (e.g., a desired final orientation), as in
If the replacement heart valve implant 100 is positioned incorrectly, as in
Accordingly, the relative position of a single longitudinal marker element of the plurality of longitudinal marker elements 80 with respect to other marker elements of the plurality of longitudinal marker elements 80 in the cusp overlap view (e.g.,
During delivery of the replacement heart valve implant 100 to the native heart valve, deployment of the replacement heart valve implant 100 may include shifting the replacement heart valve implant 100 from the radially collapsed configuration to the radially expanded configuration. In some embodiments, the proximal portion of the replacement heart valve implant 100 may be released and/or radially expanded first and/or before the distal portion of the replacement heart valve implant 100.
As discussed herein, the plurality of longitudinal marker elements 80 may be aligned with the plurality of posts 122 and the plurality of commissures of the replacement heart valve implant 100 when the replacement heart valve implant 100 is constrained within the implant holding portion 60 of the implant delivery system 30. The plurality of longitudinal marker elements 80 may be configured to rotationally align commissures of the replacement heart valve implant 100 with native valve commissures 18 of the native heart valve (e.g., the aortic valve 12) under fluoroscopy with the imaging device when the replacement heart valve implant 100 is shifted from the radially collapsed configuration to the radially expanded configuration within the native heart valve (e.g., the aortic valve 12). Accordingly, if the plurality of longitudinal marker elements 80 is rotationally aligned with the native valve commissures 18 of the native heart valve (e.g., the aortic valve 12) when the replacement heart valve implant 100 is shifted from the radially collapsed configuration to the radially expanded configuration within the native heart valve (e.g., the aortic valve 12), the plurality of posts 122 and the plurality of commissures of the replacement heart valve implant 100 will be aligned with the native valve commissures 18 of the native heart valve (e.g., the aortic valve 12).
In some embodiments, a method of delivering the replacement heart valve implant 100 to the native heart valve (e.g., the aortic valve 12), may comprise configuring an imaging device to produce a 3-cusp view of the native heart valve (e.g., the aortic valve 12) in a first position and a cusp overlap view of the native heart valve (e.g., the aortic valve 12) in a second position. In some alternative embodiments, two separate imaging devices may be used, with a first imaging device configured to produce the 3-cusp view and a second imaging device configuration to produce the cusp overlap view. Other configurations are also contemplated.
The method of delivering the replacement heart valve implant 100 to the native heart valve (e.g., the aortic valve 12) may comprise advancing the implant delivery system 30 to a position adjacent the native heart valve (e.g., the aortic valve 12), wherein the replacement heart valve implant 100 is constrained within the implant holding portion 60 of the implant delivery system 30.
The method of delivering the replacement heart valve implant 100 to the native heart valve (e.g., the aortic valve 12) may comprise imaging the implant delivery system 30 adjacent the native heart valve (e.g., the aortic valve 12) under fluoroscopy with the imaging device to determine an initial orientation of the replacement heart valve implant 100 relative to the native heart valve (e.g., the aortic valve 12) via relative positioning of the plurality of longitudinal marker elements 80 of the implant delivery system 30 within the native heart valve (e.g., the aortic valve 12). In at least some embodiments, it may be desirable for the plurality of posts 122 and the plurality of commissures of the replacement heart valve implant 100 to be rotationally aligned with the native valve commissures 18 of the native valve (e.g., the aortic valve 12), as shown generally in
In some embodiments, the method of delivering the replacement heart valve implant 100 to the native heart valve (e.g., the aortic valve 12) may comprise assessing the initial orientation under fluoroscopy in the 3-cusp view to determine if rotation of the implant delivery system 30 and the replacement heart valve implant 100 is needed to rotationally align the plurality of posts 122 and the plurality of commissures of the replacement heart valve implant 100 with the native valve commissures 18 of the native heart valve (e.g., the aortic valve 12). In some embodiments, a desired final orientation of the replacement heart valve implant 100 may include the plurality of longitudinal marker elements 80 being equally spaced apart under fluoroscopy in the 3-cusp view. If the plurality of longitudinal marker elements 80 appears to show a single longitudinal marker element of the plurality of longitudinal marker elements 80 isolated to the right of the other marker elements of the plurality of longitudinal marker elements 80 in the 3-cusp view, or a single longitudinal marker element of the plurality of longitudinal marker elements 80 isolated to the left of the other marker elements of the plurality of longitudinal marker elements 80 in the 3-cusp view, the plurality of longitudinal marker elements 80 (and thus the plurality of posts 122 and the plurality of commissures of the replacement heart valve implant 100) may be misaligned with the native valve commissures 18.
In some embodiments, imaging the implant delivery system 30 adjacent the native heart valve (e.g., the aortic valve 12) under fluoroscopy with the imaging device may comprise imaging the implant delivery system 30 and the native heart valve (e.g., the aortic valve 12) in the 3-cusp view, and switching to the cusp overlap view to determine a direction of rotation of the implant delivery system 30 and the replacement heart valve implant 100 required to position the replacement heart valve implant 100 in the desired final orientation with as little rotation as possible. Rotation of the implant delivery system 30 and the replacement heart valve implant 100 in situ may cause injury to the patient's vasculature and/or the native heart valve and thus, when necessary, should be minimized to limit unnecessary risk and/or discomfort to the patient. In some embodiments, assessing the initial orientation under fluoroscopy in the 3-cusp view may include determining the direction of rotation to be counterclockwise if the plurality of longitudinal marker elements 80 appears to show a single longitudinal marker element of the plurality of longitudinal marker elements 80 isolated to the left of the other marker elements of the plurality of longitudinal marker elements 80 in the 3-cusp view. In some embodiments, assessing the initial orientation under fluoroscopy in the 3-cusp view may include determining the direction of rotation to be clockwise if the plurality of longitudinal marker elements 80 appears to show a single longitudinal marker element of the plurality of longitudinal marker elements 80 isolated to the right of the other marker elements of the plurality of longitudinal marker elements 80 in the 3-cusp view.
In some embodiments, the method of delivering the replacement heart valve implant 100 to the native heart valve (e.g., the aortic valve 12) may comprise rotating the implant delivery system 30 and the replacement heart valve implant 100 in situ to position the replacement heart valve implant 100 in the desired final orientation by aligning the plurality of longitudinal marker elements 80 with the native valve commissures 18 of the native heart valve (e.g., the aortic valve 12). In some embodiments, rotating the implant delivery system 30 and the replacement heart valve implant 100 in situ may include rotating the implant delivery system 30 and the replacement heart valve implant 100 60 degrees or less about the central longitudinal axis of the elongate shaft assembly 50 of the implant delivery system 30. In some embodiments, rotating the implant delivery system 30 and the replacement heart valve implant 100 in situ may include rotating the implant delivery system 30 and the replacement heart valve implant 100 until the plurality of longitudinal marker elements 80 appear to be equally spaced apart under fluoroscopy in the 3-cusp view, as seen in
In some embodiments, in the desired final orientation, a single longitudinal marker element of the plurality of longitudinal marker elements 80 may be positioned farther away from the non-coronary cusp N of the native heart valve (e.g., the aortic valve 12) than other marker elements of the plurality of longitudinal marker elements 80 in the cusp overlap view, as seen in
In some embodiments, the method of delivering the replacement heart valve implant 100 to the native heart valve (e.g., the aortic valve 12) may comprise deploying the replacement heart valve implant 100 within the native heart valve (e.g., the aortic valve 12) with the plurality of posts 122 and the plurality of commissures of the replacement heart valve implant 100 rotationally aligned with the native valve commissures 18 of the native heart valve (e.g., the aortic valve 12). Deploying the replacement heart valve implant 100 within the native heart valve (e.g., the aortic valve 12) may include radially expanding the replacement heart valve implant 100 and/or the expandable framework 110 to the radially expanded configuration within the native heart valve (e.g., the aortic valve 12) while the plurality of posts 122 and the plurality of commissures of the replacement heart valve implant 100 are rotationally aligned with the native valve commissures 18 of the native heart valve (e.g., the aortic valve 12).
The materials that can be used for the various components of the replacement heart valve system and the various elements thereof disclosed herein may include those commonly associated with medical devices. For simplicity purposes, the following discussion refers to the system. However, this is not intended to limit the devices, components, and methods described herein, as the discussion may be applied to other elements, members, components, or devices disclosed herein, such as, but not limited to, the replacement heart valve implant, the expandable framework, the plurality of valve leaflets, the implant delivery system, the handle, the elongate shaft assembly, etc. and/or elements or components thereof.
In some embodiments, the system and/or components thereof may be made from a metal, metal alloy, polymer, a metal-polymer composite, ceramics, combinations thereof, and the like, or other suitable material.
Some examples of suitable polymers may include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM; for example, DELRIN®), polyether block ester, polyurethane, polypropylene (PP), polyvinylchloride (PVC), polyether-ester (for example, ARNITEL®), ether or ester based copolymers (for example, butylene/poly(alkylene ether) phthalate and/or other polyester elastomers such as HYTREL®), polyamide (for example, DURETHAN® or CRISTAMID®), elastomeric polyamides, block polyamide/ethers, polyether block amide (PEBA; for example, PEBAX®), ethylene vinyl acetate copolymers (EVA), silicones, polyethylene (PE), MARLEX® high-density polyethylene, MARLEX® low-density polyethylene, linear low density polyethylene (for example, REXELL®), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), poly paraphenylene terephthalamide (for example, KEVLAR®), polysulfone, nylon, nylon-12 (such as GRILAMID®), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefin, polystyrene, epoxy, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (for example, SIBS and/or SIBS 50A), polycarbonates, polyurethane silicone copolymers (for example, Elast-Eon® or ChronoSil®), biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers thereof, polymer/metal composites, and the like. In some embodiments, the system and/or components thereof can be blended with a liquid crystal polymer (LCP). For example, the mixture can contain up to about 6 percent LCP.
Some examples of suitable metals and metal alloys include stainless steel, such as 304 and/or 316 stainless steel and/or variations thereof; mild steel; nickel-titanium alloy such as linear-elastic and/or super-elastic nitinol; other nickel alloys such as nickel-chromium-molybdenum alloys (e.g., UNS: N06625 such as INCONEL® 625, UNS: N06022 such as HASTELLOY® C-22®, UNS: N10276 such as HASTELLOY® C276®, other HASTELLOY® alloys, and the like), nickel-copper alloys (e.g., UNS: N04400 such as MONEL® 400, NICKELVAC® 400, NICORROS® 400, and the like), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035 such as MP35-N® and the like), nickel-molybdenum alloys (e.g., UNS: N10665 such as 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, and the like; cobalt-chromium alloys; cobalt-chromium-molybdenum alloys (e.g., UNS: R30003 such as ELGILOY®, PHYNOX®, and the like); platinum enriched stainless steel; titanium; platinum; palladium; gold; combinations thereof; or any other suitable material.
In at least some embodiments, portions or all of the system and/or components thereof may also be doped with, made of, or otherwise include a radiopaque material. Radiopaque materials are understood to be materials capable of producing a relatively bright image on a fluoroscopy screen or another imaging technique (e.g., ultrasound, etc.) during a medical procedure. This relatively bright image aids the user of the system in determining its location. Some examples of radiopaque materials can include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloy, polymer material loaded with a radiopaque filler, and the like. Additionally, other radiopaque marker bands and/or coils may also be incorporated into the design of the system to achieve the same result.
In some embodiments, a degree of Magnetic Resonance Imaging (MRI) compatibility is imparted into the system and/or other elements disclosed herein. For example, the system and/or components or portions thereof may be made of a material that does not substantially distort the image and create substantial artifacts (e.g., gaps in the image). Certain ferromagnetic materials, for example, may not be suitable because they may create artifacts in an MRI image. The system or portions thereof may also be made from a material that the MRI machine can image. Some materials that exhibit these characteristics include, for example, tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS: R30003 such as ELGILOY®, PHYNOX®, and the like), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035 such as MP35-NR and the like), nitinol, and the like, and others.
In some embodiments, the system and/or other elements disclosed herein may include a fabric material disposed over or within the structure. The fabric material may be composed of a biocompatible material, such a polymeric material or biomaterial, adapted to promote tissue ingrowth. In some embodiments, the fabric material may include a bioabsorbable material. Some examples of suitable fabric materials include, but are not limited to, polyethylene glycol (PEG), nylon, polytetrafluoroethylene (PTFE, ePTFE), a polyolefinic material such as a polyethylene, a polypropylene, polyester, polyurethane, and/or blends or combinations thereof.
In some embodiments, the system and/or other elements disclosed herein may include and/or be formed from a textile material. Some examples of suitable textile materials may include synthetic yarns that may be flat, shaped, twisted, textured, pre-shrunk or un-shrunk. Synthetic biocompatible yarns suitable for use in the present disclosure include, but are not limited to, polyesters, including polyethylene terephthalate (PET) polyesters, polypropylenes, polyethylenes, polyurethanes, polyolefins, polyvinyls, polymethylacetates, polyamides, naphthalene dicarboxylene derivatives, natural silk, and polytetrafluoroethylenes. Moreover, at least one of the synthetic yarns may be a metallic yarn or a glass or ceramic yarn or fiber. Useful metallic yarns include those yarns made from or containing stainless steel, platinum, gold, titanium, tantalum, or a Ni—Co—Cr-based alloy. The yarns may further include carbon, glass, or ceramic fibers. Desirably, the yarns are made from thermoplastic materials including, but not limited to, polyesters, polypropylenes, polyethylenes, polyurethanes, polynaphthalenes, polytetrafluoroethylenes, and the like. The yarns may be of the multifilament, monofilament, or spun types. The type and denier of the yarn chosen may be selected in a manner which forms a biocompatible and implantable prosthesis and, more particularly, a vascular structure having desirable properties.
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 anti-thrombogenic agents (such as heparin, heparin derivatives, urokinase, and PPack (dextrophenylalanine proline arginine chloromethyl ketone)); anti-proliferative 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); antineoplastic/antiproliferative/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); anti-coagulants (such as D-Phe-Pro-Arg chloromethyl ketone, an RGD peptide-containing compound, heparin, anti-thrombin compounds, platelet receptor antagonists, anti-thrombin 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 repressors, translational repressors, replication inhibitors, inhibitory antibodies, antibodies directed against growth factors, bifunctional molecules consisting of a growth factor and a cytotoxin, bifunctional molecules consisting of an antibody and a cytotoxin); immunosuppressants (such as the “olimus” family of drugs, rapamycin analogues, macrolide antibiotics, biolimus, everolimus, zotarolimus, temsirolimus, picrolimus, novolimus, myolimus, tacrolimus, sirolimus, pimecrolimus, etc.); cholesterol-lowering agents; vasodilating agents; and agents which interfere with endogenous vasoactive mechanisms.
It should be understood that this disclosure is, in many respects, only 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 that it is appropriate, the use of any of the features of one example embodiment being used in other embodiments. The scope of the disclosure is, of course, defined in the language in which the appended claims are expressed.
This application claims the benefit of priority of U.S. Provisional Application No. 63/452,564 filed Mar. 16, 2023, the entire disclosure of which is hereby incorporated by reference.
| Number | Date | Country | |
|---|---|---|---|
| 63452564 | Mar 2023 | US |
