Patent Grant
11672541
The left atrial appendage (LAA) is a small organ attached to the left atrium of the heart as a pouch-like extension. In patients suffering from atrial fibrillation, the left atrial appendage may not properly contract with the left atrium, causing stagnant blood to pool within its interior, which can lead to the undesirable formation of thrombi within the left atrial appendage. Thrombi forming in the left atrial appendage may break loose from this area and enter the blood stream. Thrombi that migrate through the blood vessels may eventually plug a smaller vessel downstream and thereby contribute to stroke or heart attack. Clinical studies have shown that the majority of blood clots in patients with atrial fibrillation are found in the left atrial appendage. As a treatment, medical devices have been developed which are positioned in the left atrial appendage and deployed to close off the ostium of the left atrial appendage. Over time, the exposed surface(s) spanning the ostium of the left atrial appendage becomes covered with tissue (a process called endothelization), effectively removing the left atrial appendage from the circulatory system and reducing or eliminating the number of thrombi which may enter the blood stream from the left atrial appendage. A continuing need exists for improved medical devices and methods to control thrombus formation within the left atrial appendage of patients suffering from atrial fibrillation.
An example occlusive implant include an expandable framework configured to shift between a first configuration and a second expanded configuration, an occlusive member disposed along at least a portion of an outer surface of the expandable framework and a resilient member coupled to the occlusive member. Further, the resilient member is configured to keep the occlusive member taut against an outer surface of the expandable member in both the first configuration and the second configuration.
In addition or alternatively, wherein the resilient member includes a spring having a first end attached to the occlusive member and a second end coupled to the expandable frame.
In addition or alternatively, wherein the resilient member includes an elastic band having a first end attached to the occlusive member and a second end coupled to the expandable frame.
In addition or alternatively, wherein further comprising a first resilient member including a spring and a second resilient member including an elastic band, wherein each of the spring and the elastic band has a first end attached to the occlusive member and a second end coupled to the expandable frame.
In addition or alternatively, wherein the resilient member includes one or more elastic fibers integrated with the occlusive member, and wherein the one or more elastic fibers are deigned to elongate and contract as the expandable member shifts between the first configuration and the second expanded configuration.
In addition or alternatively, wherein the occlusive member includes one or more inelastic fibers and wherein the one or more elastic fibers are interwoven with the one or more inelastic fibers.
In addition or alternatively, further comprising a plurality of rigid members disposed along the occlusive member, wherein each of the plurality of rigid members include an aperture designed to permit fluid to flow therethrough.
In addition or alternatively, wherein the occlusive member includes a mesh structure, and wherein the resilient member includes one or more elastic members interconnected to form an elastic matrix, and wherein the mesh structure is coupled to the elastic matrix.
In addition or alternatively, wherein the expandable matrix includes a plurality of interstices spaced throughout the matrix, and wherein the mesh structure is disposed within the plurality of interstices.
In addition or alternatively, further comprising a hub member disposed adjacent the occlusive member, and wherein the resilient member includes a coil member disposed around the hub member, and wherein the coil member is designed to tighten the occlusive member as the expandable member shifts between the first configuration and the second expanded configuration.
In addition or alternatively, further comprising a hub member disposed adjacent the occlusive member, and wherein the resilient member includes a ratcheting member disposed around the hub member, and wherein the ratcheting member is designed to rotate and tighten the occlusive member as the expandable member shifts between the first configuration and the second expanded configuration.
In addition or alternatively, further comprising a core wire coupled to the ratcheting member, and wherein the core wire is designed to rotate the ratcheting member.
Another occlusive implant includes:
an expandable framework configured to shift between a first configuration and a second expanded configuration;
an occlusive member disposed along at least a portion of an outer surface of the expandable framework; and
a tightening member coupled to the expandable framework, the occlusive member or both the expandable framework and the occlusive member;
wherein rotation of the tightening member is configured to keep the occlusive member taut against an outer surface of the expandable member in both the first configuration and the second configuration.
In addition or alternatively, further comprising a hub member coupled to the expandable framework, and wherein the tightening member includes a coil member disposed along the hub member, and wherein rotation of the coil member is designed to keep the occlusive member taut against the outer surface of the expandable member in both the first configuration and the second configuration.
In addition or alternatively, wherein the coil member is wound around an outer surface of the hub member.
In addition or alternatively, further comprising a hub member coupled to the expandable framework, and wherein the tightening member includes a ratcheting member disposed adjacent to the hub member, and wherein rotation of the ratcheting member is designed to keep the occlusive member taut against the outer surface of the expandable member in both the first configuration and the second configuration.
In addition or alternatively, further comprising a core wire coupled to the ratcheting member, and wherein rotating the core wire in a first direction is designed to rotate the ratcheting member.
In addition or alternatively, wherein the ratcheting member is designed to rotate in a first direction, and wherein the ratcheting member is prevented from rotating in a second direction opposite the first direction, and wherein the occlusive member is tightened when the ratcheting member is rotated in the first direction.
In addition or alternatively, wherein rotation of the core wire in the second direction is designed to separate the core wire from the ratcheting member while the ratcheting member keeps the occlusive member taut against the outer surface of the expandable member.
A method for occluding a left atrial appendage includes:
advancing an occlusive implant to the left atrial appendage, the occlusive implant including:
expanding the expandable framework within the left atrial appendage, wherein during expanding the expandable framework within the left atrial appendage the resilient member keeps the occlusive member taut against an outer surface of the expandable member.
The above summary of some embodiments, aspects, and/or examples is not intended to describe each embodiment or every implementation of the present disclosure. The figures and the detailed description which follows more particularly exemplify these embodiments.
The disclosure may be more completely understood in consideration of the following detailed description of various embodiments 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 claimed 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 claimed disclosure. However, in the interest of clarity and ease of understanding, while every feature and/or element may not be shown in each drawing, the feature(s) and/or element(s) may be understood to be present regardless, unless otherwise specified.
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 in order 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 simplicity and clarity purposes, not all elements of the disclosure are necessarily shown in each figure or discussed in detail below. However, it will be understood that the following discussion may apply equally to any and/or all of the components for which there are more than one, unless explicitly stated to the contrary. Additionally, not all instances of some elements or features may be shown in each figure for clarity.
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 in an effort 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.
The term “extent” may be understood to mean a 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 a smallest measurement of the stated or identified dimension. For example, “outer extent” may be understood to mean a maximum outer dimension, “radial extent” may be understood to mean a maximum radial dimension, “longitudinal extent” may be understood to mean a maximum 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 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 effect 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.
The occurrence of thrombi in the left atrial appendage (LAA) during atrial fibrillation may be due to stagnancy of blood pooling in the LAA. The pooled blood may still be pulled out of the left atrium by the left ventricle, however less effectively due to the irregular contraction of the left atrium caused by atrial fibrillation. Therefore, instead of an active support of the blood flow by a contracting left atrium and left atrial appendage, filling of the left ventricle may depend primarily or solely on the suction effect created by the left ventricle. However, the contraction of the left atrial appendage may not be in sync with the cycle of the left ventricle. For example, contraction of the left atrial appendage may be out of phase up to 180 degrees with the left ventricle, which may create significant resistance to the desired flow of blood. Further still, most left atrial appendage geometries are complex and highly variable, with large irregular surface areas and a narrow ostium or opening compared to the depth of the left atrial appendage. These aspects as well as others, taken individually or in various combinations, may lead to high flow resistance of blood out of the left atrial appendage.
In an effort to reduce the occurrence of thrombi formation within the left atrial appendage and prevent thrombi from entering the blood stream from within the left atrial appendage, it may be desirable to develop medical devices and/or occlusive implants that close off the left atrial appendage from the heart and/or circulatory system, thereby lowering the risk of stroke due to thromboembolic material entering the blood stream from the left atrial appendage. Example medical devices and/or occlusive implants that close off the left atrial appendage are disclosed herein.
The delivery catheter 23 may include a manifold 21. The manifold 21 may be manipulated by a clinician to direct the distal end region of the delivery catheter 23 to a position adjacent the left atrial appendage 50. In some embodiments, an occlusive implant delivery system may include a core wire 17. Further, a proximal end region 11 of the expandable framework 12 may be configured to releasably attach, join, couple, engage, or otherwise connect to the distal end of the core wire 17. In some embodiments, the proximal end region 11 of the expandable framework 12 may include a threaded insert coupled thereto. In some embodiments, the threaded insert may be configured to and/or adapted to couple with, join to, mate with, or otherwise engage a threaded member disposed at the distal end of a core wire 17. Other means of releasably coupling and/or engaging the proximal end region 11 of the expandable framework 12 to the distal end of the core wire 17 are also contemplated.
In some instances, it may be desirable to design the occlusive implant 10 described herein to include features which allow it to accommodate patient-to-patient variability in the shape of the left atrial appendage. In other words, it may be desirable to design the occlusive implant 10 such that a clinician may utilize the same device irrespective of the particular anatomy presented by a particular patient. For example, it is known that the diameter of the opening (e.g., orifice) of the left atrial appendage may vary widely among individuals. In particular, the diameter of the opening to the left atrial appendage may be narrower in certain individuals as compared to others. Therefore, it may be desirable to design the occlusive implant 10 such that it can change its shape to fit different orifice diameters of the left atrial appendage without sacrificing its effectiveness in sealing the left atrial appendage. In particular, it may be desirable to design the occlusive implant 10 such that it can expand or collapse without substantially changing the distance in which it extends into the left atrial appendage and without substantially changing the radial force in which it exerts upon the surrounding tissue. For example, the expandable framework 12 illustrated in
Further, it can be appreciated that the structural elements of the expandable framework 12 may be tailored to increase the flexibility of the expandable framework 12 and/or the occlusive implant 10, thereby permitting the expandable framework 12 and/or the occlusive implant 10 to conform to the tissue around it, rather than forcing the tissue to conform to the expandable framework 12 and/or the occlusive implant 10. Additionally, in some instances, it may be desirable to design the occlusive implant 10 to include various features, components and/or configurations which improve the sealing capabilities of the occlusive implant 10 within the left atrial appendage 50.
For example,
Additionally,
In some embodiments, the occlusive member 114 may be permeable or impermeable to blood and/or other fluids, such as water. In some embodiments, the occlusive member 114 may include a woven, braided and/or knitted material, a fiber, a sheet-like material, a fabric, a polymeric membrane, a metallic or polymeric mesh, a porous filter-like material, or other suitable construction. In some embodiments, the occlusive member 114 may prevent thrombi (e.g., blood clots, etc.) from passing through the occlusive member 114 and out of the left atrial appendage into the blood stream. In some embodiments, the occlusive member 114 may promote endothelization after implantation, thereby effectively removing the left atrial appendage from the patient's circulatory system. Some suitable, but non-limiting, examples of materials for the occlusive member 114 are discussed below.
In some examples, the expandable framework 112 and the plurality of anchor members 116 may be integrally formed and/or cut from a unitary member. In some embodiments, the expandable framework 112 and the plurality of anchor members 116 may be integrally formed and/or cut from a unitary tubular member and subsequently formed and/or heat set to a desired shape in the expanded configuration. In some embodiments, the expandable framework 112 and the plurality of anchor members 116 may be integrally formed and/or cut from a unitary flat member, and then rolled or formed into a tubular structure and subsequently formed and/or heat set to the desired shape in the expanded configuration. Some exemplary means and/or methods of making and/or forming the expandable framework 112 include laser cutting, machining, punching, stamping, electro discharge machining (EDM), chemical dissolution, etc. Other means and/or methods are also contemplated.
As illustrated in
As discussed above, in some instances it may be desirable to design the medical device implants disclosed herein to accommodate a variety of different patient populations (e.g., to accommodate the different shapes of left atrial appendages across different patients). For example, the medical device 110 may be designed such that it may expand and/or contract depending upon the particular diameter of a left atrial appendage in which it is being positioned. Further, it can be appreciated that an occlusive member disposed on, disposed over, disposed about or covering at least a portion of an outer (or outwardly-facing) surface of the expandable framework 112 may also be designed to expand and/or contract coincident with the expansion and/or contract of the expandable framework 112.
It can be appreciated that a variety of different structures may be incorporated within the expandable framework 112 and/or the occlusive member 114 which are designed to permit the occlusive member 114 to remain disposed along the outer surface of the expandable framework 112 as the expandable framework 112 shifts between an unexpanded and an expanded configuration. In other words, a variety of different structures may be incorporated within the expandable framework 112 and/or the occlusive member 114 which are designed to maintain the occlusive member 114 under tension (e.g., substantially taut) along the outer surface of the expandable framework 112. Keeping the occlusive member 114 taut along the outer surface of the expandable framework 112 may prevent the occlusive member 114 from forming wrinkles therein as the expandable framework shift between an unexpanded configuration and an expanded configuration. It may be desirable to reduce wrinkles in the occlusive member 114 to reduce the likelihood that particulate (e.g., thrombus) may be trapped therein.
Additionally,
Additionally,
Additionally, the detailed view of
It can be appreciated that the elastic fibers 317 may be compressed or stretched from a relaxed position. It can be further appreciated that the elastic fibers 317 may be designed such that they keep the occlusive member 314 taut against the outer surface of the expandable framework 312. Further, it can be appreciated that the ability of the elastic fibers 317 to expand and/or contract while maintaining a tension along the occlusive member 314 may keep the occlusive member 314 taut against the outer surface of the expandable framework 312 as the size of the framework member 312 changes (e.g., via expansion or contraction).
Additionally,
It can be appreciated that the elastic elements 417 in combination with the woven mesh portions 415 may be compressed or stretched. It can be further appreciated that the elastic elements 417 in combination with the woven mesh portions 415 may be designed such that they keep the occlusive member 414 taut against the outer surface of the expandable framework 412. Further, it can be appreciated that the ability of the elastic elements 417 in combination with the woven mesh portions 415 to expand and/or contract while maintaining a tension along the occlusive member 414 may keep the occlusive member 414 taut against the outer surface of the expandable framework 412 as the size (e.g., diameter) of the expandable framework 412 changes (e.g., via expansion or contraction).
In some instances, it may be beneficial to design the medical device 510 to include one or more apertures 521 disposed along the occlusive member 514. Similar to that described above with respect to the occlusive member 14, the occlusive member 514 may include a mesh structure 515 disposed along the exterior surface of the expandable framework 512. For example, the mesh structure 515 may include elastic fibers woven together to form the mesh structure 515. In some examples, the mesh structure 515 may include inelastic fibers interwoven with the elastic fibers (similar to the mesh structure illustrated and described with respect to the detail view of
As discussed above, it may be beneficial to include one or more apertures 521 disposed with the mesh structure 515. Each of the apertures 521 may be formed from a rigid material (e.g., polymeric rings), wherein the apertures 521 resist deformation as the occlusive member 514 expands or contracts with the expansion or contraction of the expandable framework 512. However, this is not intended to be limiting. It is contemplated that the apertures 521 may be formed from an elastic and/or semi-rigid material.
In some examples it may be desirable to design the apertures 521 to allow blood to flow therethrough. It can further be appreciated that designing the occlusive member 514 to include a plurality of apertures 521 formed from a rigid material may result in the occlusive member 514 maintaining a consistent “porosity” as the occlusive member 514 expands or contracts with the expansion or contraction of the expandable framework 512. Maintaining a consistent porosity as the occlusive member 514 expands or contracts may be desirable to maintain a consistent volume of blood flowing through the occlusive member 514 independent of the degree to which the expandable framework 512 expands or contracts.
Further,
It can be appreciated from
To that end,
It can be appreciated that the spring member 623 may be designed to wind the occlusive member 614 around the hub member 625 to collect the slack of the occlusive member 614 and thereby maintain the occlusive member 614 under tension (e.g., substantially taut) along the outer surface of the expandable framework 612. Keeping the occlusive member 614 taut along the outer surface of the expandable framework 612 may prevent the occlusive member 614 from forming wrinkles therein as the expandable framework 612 shifts between an unexpanded configuration and an expanded configuration. It may be desirable to reduce wrinkles in the occlusive member 614 to reduce the likelihood that particulate (e.g., thrombus) may be trapped therein.
Similar to the medical device 610 described above, in some instances it may be desirable to design medical device 710 include one or more elements which collect and tighten the occlusive member 714 around the outer surface of the expandable framework 712 as the expandable framework 712 contracts from an expanded configuration to an unexpanded configuration. To that end, the medical device 710 may include a ratcheting member 727 coupled to a hub member 725, the occlusive member 714 or both the hub member 725 and the occlusive member 714. Additionally, the ratcheting member 727 may be coupled to the core wire 17 (described above with respect to
The medical device 810 may include an expandable member 816. The expandable member 816 may also be referred to as an expandable balloon 816. The expandable member 816 may be formed from a highly compliant material (e.g., “inflation material”) which permits the expandable member 816 to expand from a first unexpanded (e.g., deflated, collapsed) configuration to a second expanded (e.g., inflated) configuration. In some examples, the expandable member 816 may be inflated to pressures from about 4 psi to 200 psi. It can be appreciated that the outer diameter of the occlusive member 810 may be larger in the expanded configuration versus the unexpanded configuration.
In some examples, the expandable member 816 may be constructed from silicone or a low-durometer polymer, however, other materials are contemplated. Additionally, the expandable member 816 may be impermeable to blood and/or other fluids, such as water. In some embodiments, the expandable member 816 may include a woven, braided and/or knitted material, a fiber, a sheet-like material, a metallic or polymeric mesh, or other suitable construction. Further, in some embodiments, the expandable member 816 may prevent thrombi (e.g., blood clots, etc.) originating in the left atrial appendage from passing through the occlusive member 810 and into the blood stream. Further, in some instances the occlusive member 810 may promote endothelial growth after implantation, thereby effectively removing the left atrial appendage from the patient's circulatory system. Some suitable, but non-limiting, examples of materials for the occlusive member 810 are discussed below.
However, it is contemplated that in some instances the spacing between spine members 818 may not be uniform. In some examples, the spacing between adjacent spine members 818 may be variable (e.g., non-uniformly spaced) around the circumference of the expandable member 816. Additionally, it is contemplated that the spine members 818 may form a framework in which the spine members 818 are connected to one another via a series of laterally extending members. A variety of different geometries for example frameworks are contemplated.
As illustrated in
In some instances, it may be beneficial to design the medical device 810 to include one or more apertures 821 disposed along the occlusive member 814. Similar to that described above with respect to the occlusive member 14, the occlusive member 814 may include a mesh structure 815 disposed along the exterior surface of the expandable member 816. For example, the mesh structure 815 may include elastic fibers woven together to form the mesh structure 815. In some examples, the mesh structure 815 may include inelastic fibers interwoven with elastic fibers.
As discussed above, it may be beneficial to include one or more apertures 821 disposed with the mesh structure 815. Each of the apertures 821 may be formed from a rigid material (e.g., polymeric rings), wherein the apertures 821 resist deformation as the occlusive member 814 expands or contracts with the expansion or contraction of the expandable member 816. In some examples, the diameter of each of the apertures 821 may be about 10 μm to 200 μm, or about 15 μm to 150 μm, or about 25 μm. However, this is not intended to be limiting. Further, it is contemplated that the apertures 821 may be formed from an elastic and/or semi-elastic material.
In some examples it may be desirable to design the apertures 821 to allow blood to flow therethrough. It can further be appreciated that designing the occlusive member 814 to include a plurality of apertures 821 formed from a rigid material may result in the occlusive member 814 maintaining a consistent “porosity” as the occlusive member 814 expands or contracts with the expansion or contraction of the expandable member 816. Maintaining a consistent porosity as the occlusive member 814 expands or contracts may be desirable to maintain a consistent filtering capacity for a given amount of blood flowing through the occlusive member 814 independent of the degree to which the expandable member 816 expands or contracts. The consistent porosity may also provide sufficient occlusive material to optimize endothelial growth thereon.
Additionally,
Similar to the apertures described with respect to
It can be appreciated that the fiber matrix (including the fiber elements 917 and the apertures 921) in combination with the woven mesh portions 915 may be compressed or stretched. It can be further appreciated that the fiber matrix (including the fiber elements 917 and the apertures 921) in combination with the woven mesh portions 915 may be designed such that they keep the occlusive member 914 taut against the outer surface of the expandable member 916. Further, it can be appreciated that the ability of the fiber matrix (including the fiber elements 917 and the apertures 921) in combination with the woven mesh portions 915 to expand and/or contract while maintaining a tension along the occlusive member 914 may keep the occlusive member 914 taut against the outer surface of the expandable member 916 as the size of the expandable member 912 changes (e.g., via expansion or contraction).
The materials that can be used for the various components of the occlusive implant 10 (and variations, systems or components thereof disclosed herein) and the various elements thereof disclosed herein may include those commonly associated with medical devices. For simplicity purposes, the following discussion makes reference to the occlusive implant 10 (and variations, systems or components disclosed herein). However, this is not intended to limit the devices and methods described herein, as the discussion may be applied to other elements, members, components, or devices disclosed herein.
In some embodiments, the occlusive implant 10 (and variations, systems or components thereof disclosed herein) may be made from a metal, metal alloy, polymer (some examples of which are disclosed below), a metal-polymer composite, ceramics, combinations thereof, and the like, or other suitable material. Some examples of suitable metals and metal alloys include stainless steel, such as 444V, 444L, and 314LV stainless steel; 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: R44035 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: R44003 such as ELGILOY®, PHYNOX®, and the like); platinum enriched stainless steel; titanium; platinum; palladium; gold; combinations thereof; and the like; or any other suitable material.
As alluded to herein, within the family of commercially available nickel-titanium or nitinol alloys, is a category designated “linear elastic” or “non-super-elastic” which, although may be similar in chemistry to conventional shape memory and super elastic varieties, may exhibit distinct and useful mechanical properties. Linear elastic and/or non-super-elastic nitinol may be distinguished from super elastic nitinol in that the linear elastic and/or non-super-elastic nitinol does not display a substantial “superelastic plateau” or “flag region” in its stress/strain curve like super elastic nitinol does. Instead, in the linear elastic and/or non-super-elastic nitinol, as recoverable strain increases, the stress continues to increase in a substantially linear, or a somewhat, but not necessarily entirely linear relationship until plastic deformation begins or at least in a relationship that is more linear than the super elastic plateau and/or flag region that may be seen with super elastic nitinol. Thus, for the purposes of this disclosure linear elastic and/or non-super-elastic nitinol may also be termed “substantially” linear elastic and/or non-super-elastic nitinol.
In some cases, linear elastic and/or non-super-elastic nitinol may also be distinguishable from super elastic nitinol in that linear elastic and/or non-super-elastic nitinol may accept up to about 2-5% strain while remaining substantially elastic (e.g., before plastically deforming) whereas super elastic nitinol may accept up to about 8% strain before plastically deforming. Both of these materials can be distinguished from other linear elastic materials such as stainless steel (that can also be distinguished based on its composition), which may accept only about 0.2 to 0.44 percent strain before plastically deforming.
In some embodiments, the linear elastic and/or non-super-elastic nickel-titanium alloy is an alloy that does not show any martensite/austenite phase changes that are detectable by differential scanning calorimetry (DSC) and dynamic metal thermal analysis (DMTA) analysis over a large temperature range. For example, in some embodiments, there may be no martensite/austenite phase changes detectable by DSC and DMTA analysis in the range of about −60 degrees Celsius (° C.) to about 120° C. in the linear elastic and/or non-super-elastic nickel-titanium alloy. The mechanical bending properties of such material may therefore be generally inert to the effect of temperature over this very broad range of temperature. In some embodiments, the mechanical bending properties of the linear elastic and/or non-super-elastic nickel-titanium alloy at ambient or room temperature are substantially the same as the mechanical properties at body temperature, for example, in that they do not display a super-elastic plateau and/or flag region. In other words, across a broad temperature range, the linear elastic and/or non-super-elastic nickel-titanium alloy maintains its linear elastic and/or non-super-elastic characteristics and/or properties.
In some embodiments, the linear elastic and/or non-super-elastic nickel-titanium alloy may be in the range of about 50 to about 60 weight percent nickel, with the remainder being essentially titanium. In some embodiments, the composition is in the range of about 54 to about 57 weight percent nickel. One example of a suitable nickel-titanium alloy is FHP-NT alloy commercially available from Furukawa Techno Material Co. of Kanagawa, Japan. Other suitable materials may include ULTANIUM™ (available from Neo-Metrics) and GUM METAL™ (available from Toyota). In some other embodiments, a superelastic alloy, for example a superelastic nitinol can be used to achieve desired properties.
In at least some embodiments, portions or all of the occlusive implant 10 (and variations, systems or components thereof disclosed herein) 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 during a medical procedure. This relatively bright image aids a user in determining the location of the occlusive implant 10 (and variations, systems or components thereof disclosed herein). 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 occlusive implant 10 (and variations, systems or components thereof disclosed herein). to achieve the same result.
In some embodiments, a degree of Magnetic Resonance Imaging (MRI) compatibility is imparted into the occlusive implant 10 (and variations, systems or components thereof disclosed herein). For example, the occlusive implant 10 (and variations, systems or components thereof disclosed herein) 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 occlusive implant 10 (and variations, systems or components disclosed herein) 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: R44003 such as ELGILOY®, PHYNOX®, and the like), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R44035 such as MP35-N® and the like), nitinol, and the like, and others.
In some embodiments, the occlusive implant 10 (and variations, systems or components thereof disclosed herein) and/or portions thereof, may be made from or include a polymer 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® available from DuPont), polyether block ester, polyurethane (for example, Polyurethane 85A), polypropylene (PP), polyvinylchloride (PVC), polyether-ester (for example, ARNITEL® available from DSM Engineering Plastics), ether or ester based copolymers (for example, butylene/poly(alkylene ether) phthalate and/or other polyester elastomers such as HYTREL® available from DuPont), polyamide (for example, DURETHAN® available from Bayer or CRISTAMID® available from Elf Atochem), elastomeric polyamides, block polyamide/ethers, polyether block amide (PEBA, for example available under the trade name 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® available from EMS American Grilon), 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, ionomers, polyurethane silicone copolymers (for example, ElastEon® from Aortech Biomaterials or ChronoSil® from AdvanSource Biomaterials), biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers thereof, polymer/metal composites, and the like. In some embodiments, the sheath can be blended with a liquid crystal polymer (LCP). For example, the mixture can contain up to about 6 percent LCP.
In some embodiments, the occlusive implant 10 (and variations, systems or components thereof disclosed herein) may include 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 occlusive implant 10 (and variations, systems or components thereof 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 chloromethylketone)); 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 keton, 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); cholesterol-lowering agents; vasodilating agents; and agents which interfere with endogenous vascoactive mechanisms.
While the discussion above is generally directed toward an occlusive implant for use in the left atrial appendage of the heart, the aforementioned features may also be useful in other types of medical implants where a fabric or membrane is attached to a frame or support structure including, but not limited to, implants for the treatment of aneurysms (e.g., abdominal aortic aneurysms, thoracic aortic aneurysms, etc.), replacement valve implants (e.g., replacement heart valve implants, replacement aortic valve implants, replacement mitral valve implants, replacement vascular valve implants, etc.), and/or other types of occlusive devices (e.g., atrial septal occluders, cerebral aneurysm occluders, peripheral artery occluders, etc.). Other useful applications of the disclosed features are also contemplated.
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 disclosure's scope is, of course, defined in the language in which the appended claims are expressed.
This application claims the benefit of priority under 35 U.S.C. § 119 to U.S. Provisional Application Ser. No. 62/682,201, filed Jun. 8, 2018, the entirety of which is incorporated herein by reference.
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| Number | Date | Country | |
|---|---|---|---|
| 62682201 | Jun 2018 | US |
