Occlusive medical device
阅读说明:本技术 闭塞医疗装置 (Occlusive medical device ) 是由 约书亚·马克·依诺也 于 2019-02-14 设计创作,主要内容包括:公开了一种示例性闭塞植入物。该示例性闭塞植入物包括具有一定高度的可膨胀框架和多个支撑构件,所述支撑构件限定了可膨胀框架的近侧端部区域,以及附接到该多个支撑构件的中心毂部构件。此外,可膨胀框架被构造成在第一构型和第二构型之间变换,其中可膨胀框架的高度在第一构型和第二构型中都保持基本相同。此外,在可膨胀框架在第一构型和第二构型之间变换时,中心毂部构件被构造成相对于近侧端部区域变换。(An exemplary occlusive implant is disclosed. The example occlusive implant includes an expandable frame having a height and a plurality of support members defining a proximal end region of the expandable frame, and a central hub member attached to the plurality of support members. Further, the expandable frame is configured to transition between a first configuration and a second configuration, wherein the height of the expandable frame remains substantially the same in both the first configuration and the second configuration. Further, the central hub member is configured to shift relative to the proximal end region as the expandable frame shifts between the first configuration and the second configuration.)
1. An occlusive implant, comprising:
An expandable frame having a height and a plurality of support members defining a proximal end region of the expandable frame;
a center hub member attached to the plurality of support members;
wherein the expandable frame is configured to transition between a first configuration and a second configuration, wherein a height of the expandable frame remains substantially the same in both the first configuration and the second configuration; and the number of the first and second electrodes,
wherein the hub member is configured to shift relative to the proximal end region when the expandable frame is shifted between a first configuration and a second configuration.
2. The occlusive implant of claim 1, wherein the expandable frame comprises a first radially outward force in the first configuration and a second radially outward force in the second configuration, and wherein the first radially outward force is substantially equal to the second radially outward force.
3. The occlusive implant of any of claims 1-2, wherein the expandable frame includes a longitudinal axis, and wherein a central hub member is configured to translate along the longitudinal axis.
4. The occlusive implant of any of claims 1-3, wherein the central hub member shifts in a distal direction when shifting from the first configuration to the second configuration.
5. The occlusive implant of any of claims 1-4, wherein the plurality of support members define a recess within a central region of the expandable frame.
6. The occlusive implant of claim 5, wherein the central hub member is positioned within the recess.
7. The occlusive implant of any of claims 1-6, wherein the expandable member has a first width in the first configuration and a second width in the second configuration, wherein the first width is wider than the second width.
8. The occlusive implant of any of claims 5-7, wherein the recess of the expandable member has a first recess height in the first configuration and a second recess height in the second configuration, and wherein the second recess height is greater than the first recess height.
9. The occlusive implant of any of claims 1-8, further comprising a first occlusive member disposed along a proximal end region of the expandable frame.
10. The occlusive implant of any of claims 1-9, further comprising a second occlusive member disposed along a distal end region of the expandable frame.
11. A medical implant for occluding a left atrial appendage, comprising:
an expandable frame having a first height, a proximal end region, and a plurality of support members defining a central recess region; and the number of the first and second groups,
a central hub member attached to the plurality of support members and positioned within the central recessed region;
wherein the central recessed region extends a first distance into the expandable member;
wherein the expandable frame is configured to transition between an expanded configuration and a collapsed configuration;
wherein the first distance increases as the expandable frame transitions between the expanded configuration and the collapsed configuration.
12. The medical implant of claim 11, wherein the height of the expandable frame remains substantially the same in both the expanded and collapsed configurations.
13. The medical implant of any of claims 11-12, wherein the expandable frame includes a first radially outward force in the expanded configuration and a second radially outward force in the collapsed configuration, and wherein the first radially outward force is substantially equal to the second radially outward force.
14. The medical implant of any one of claims 11-13, wherein the central hub member is configured to shift relative to the proximal end region as the expandable frame shifts between the expanded configuration and the collapsed configuration.
15. The medical implant of any of claims 11-14, wherein the expandable frame includes a longitudinal axis, and wherein the central hub member is configured to translate along the longitudinal axis.
Background
The Left Atrial Appendage (LAA) is a small organ attached to the left atrium of the heart in a pocket-like extension. In patients with atrial fibrillation, the left atrial appendage may not contract properly with the left atrium, causing it to become stagnant, which may lead to undesirable thrombus formation within the left atrial appendage. Thrombi formed in the left atrial appendage may slough off the area and enter the blood stream. Thrombi migrating through the blood vessels may eventually plug smaller blood vessels downstream and thereby cause stroke or heart disease. Clinical studies have shown that most blood clots in patients with atrial fibrillation are found in the left atrial appendage. As a method of treatment, medical devices have been developed that are positioned in the left atrial appendage and deployed to isolate the ostium of the left atrial appendage. Over time, one or more exposed surfaces across the ostium of the left atrial appendage are covered with tissue (a process known as endothelialization), effectively removing the left atrial appendage from the circulatory system and reducing or eliminating the number of thrombi that may enter the blood stream from the left atrial appendage. There is a continuing need for improved medical devices and methods for controlling thrombus formation in the left atrial appendage of patients suffering from atrial fibrillation.
Disclosure of Invention
The present disclosure provides design, materials, manufacturing methods, and use alternatives for medical devices. An example occlusive implant includes an expandable frame having a height and a plurality of support members defining a proximal end region of the expandable frame, and a central hub member attached to the plurality of support members. Further, the expandable frame is configured to transition between a first configuration and a second configuration, wherein the height of the expandable frame remains substantially the same in both the first configuration and the second configuration. Further, the central hub member is configured to shift relative to the proximal end region as the expandable frame shifts between the first configuration and the second configuration.
Additionally or alternatively, wherein the expandable frame comprises a first radially outward force in the first configuration and a second radially outward force in the second configuration, and wherein the first radially outward force is substantially equal to the second radially outward force.
Additionally or alternatively, wherein the expandable frame comprises a longitudinal axis, and wherein the central hub member is configured to translate along the longitudinal axis.
Additionally or alternatively, wherein the central hub member shifts in the distal direction when shifting from the first configuration to the second configuration.
Additionally or alternatively, wherein the plurality of support members define a recess in a central region of the expandable frame.
Additionally or alternatively, wherein the central hub member is positioned within the recess.
Additionally or alternatively, wherein the expandable member has a first width in the first configuration and a second width in the second configuration, wherein the first width is wider than the second width.
Additionally or alternatively, wherein the recess of the expandable member has a first recess height in the first configuration and a second recess height in the second configuration, and wherein the second recess height is greater than the first recess height.
Additionally or alternatively, a first occlusion member disposed along a proximal end region of the expandable frame is also included.
Additionally or alternatively, a second occlusion member disposed along a distal end region of the expandable frame is also included.
Another medical implant for occluding a left atrial appendage comprises:
an expandable frame comprising a first height, a proximal end region, and a plurality of support members defining a central recess region; and the number of the first and second groups,
a central hub member attached to the plurality of support members and positioned within the central recessed region;
Wherein the central recessed region extends a first distance into the expandable member;
wherein the expandable frame is configured to transition between an expanded configuration and a collapsed configuration;
wherein the first distance increases as the expandable frame transitions between the expanded configuration and the collapsed configuration.
Additionally or alternatively, wherein the height of the expandable frame remains substantially the same in both the expanded and collapsed configurations.
Additionally or alternatively, wherein the expandable frame comprises a first radially outward force in the expanded configuration and a second radially outward force in the collapsed configuration, and wherein the first radially outward force is substantially equal to the second radially outward force.
Additionally or alternatively, wherein the central hub member is configured to shift relative to the proximal end region as the expandable frame shifts between the expanded configuration and the collapsed configuration.
Additionally or alternatively, wherein the expandable frame comprises a longitudinal axis, and wherein the central hub member is configured to translate along the longitudinal axis.
Additionally or alternatively, wherein the central hub member shifts in a distal direction when shifting from the expanded configuration to the collapsed configuration.
Additionally or alternatively, a first occlusion member disposed along a proximal end region of the expandable frame is also included.
Additionally or alternatively, a second occlusion member disposed along a distal end region of the expandable frame is also included.
An exemplary method for occluding a left atrial appendage comprises:
advancing an occlusion implant to the left atrial appendage, the occlusion implant comprising:
an expandable frame comprising a height and a plurality of support members defining a proximal end region of the expandable frame;
a center hub member attached to the plurality of support members;
wherein the expandable frame is configured to transition between a first configuration and a second configuration;
wherein the height of the expandable frame remains substantially the same in both the first configuration and the second configuration; and the number of the first and second groups,
the expandable frame is expanded within the left atrial appendage such that the expandable frame transitions between a first configuration and a second configuration.
Additionally or alternatively, wherein expanding the expandable frame from the first configuration to the second expanded configuration shifts the central hub member relative to the proximal end region.
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 that follow more particularly exemplify these embodiments.
Drawings
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:
FIG. 1 illustrates an exemplary occluding implant positioned in a heart;
FIG. 2 is a plan view of an exemplary occlusive implant;
FIG. 2A is a plan view of another exemplary occlusion implant;
FIG. 3 is a plan view of another exemplary occlusion implant;
FIG. 4 is a plan view of another exemplary occlusion implant;
FIG. 5 is a plan view of another exemplary occlusion implant;
fig. 6 illustrates an exemplary occlusion implant positioned in the left atrial appendage;
fig. 7 illustrates another exemplary occlusion implant positioned in the left atrial appendage;
FIG. 8 is a plan view of an exemplary occlusive implant;
fig. 9 illustrates an exemplary occlusion implant positioned in the left atrial appendage;
fig. 10 illustrates another exemplary occlusion implant positioned in the left atrial appendage;
FIG. 11 is a plan view of another exemplary occlusion implant;
fig. 12 is a plan view of the occlusive implant of fig. 11 in a collapsed configuration.
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.
Detailed Description
The following description should be read with reference to the accompanying drawings, which are not necessarily drawn to scale. Wherein like reference numerals refer to like elements throughout the several views. The detailed description and drawings are intended to be illustrative of the claimed disclosure rather than limiting. Those of ordinary skill in the art will recognize that the various elements described and/or illustrated may be arranged in various combinations and configurations without departing from the scope of the present disclosure. The detailed description and drawings illustrate example embodiments of the claimed disclosure. However, for clarity and ease of understanding, although not every feature and/or element is shown in every drawing, it should be understood that such feature(s) and/or element(s) may be present in any way unless otherwise indicated.
For the following defined terms, these definitions shall be applied, unless a different definition is given in the claims or elsewhere in this specification.
All numerical values are herein assumed to be modified by the term "about," whether or not explicitly indicated. In the context of numerical values, the term "about" generally refers to a range of numbers that one of ordinary skill in the art would consider equivalent to the recited value (e.g., having the same function or result). In many cases, the term "about" can include numbers rounded to the nearest significant figure. Other usage of the term "about" (e.g., in the context of other than a divisor value) can be assumed to have their ordinary and customary definition, as understood from and consistent with the context of the specification, unless otherwise specified.
The recitation of numerical ranges by endpoints includes all numbers subsumed within that range, including the recited endpoint (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 are disclosed for various components, features, and/or specifications, one of ordinary skill in the art, in light of this disclosure, will appreciate that contemplated dimensions, ranges, and/or values may deviate from the explicitly disclosed dimensions, ranges, and/or values.
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 should be noted that certain features of the disclosure may be described in the singular for ease of understanding, although these features may be in the plural or may be repeated in one or more embodiments disclosed. Each instance of such a feature may include and/or be included in one or more singular disclosures unless expressly stated to the contrary. For purposes of simplicity and clarity, not all elements of the disclosure are necessarily shown in each figure or discussed in detail below. However, it should be understood that the following discussion may apply equally to any and/or all components (more than one present) unless explicitly stated to the contrary. Moreover, not all examples of certain elements or features may be shown in each figure for clarity.
Relative terms such as "proximal", "distal", "advancing", "retracting", and variants thereof, may generally be considered in connection with the positioning, orientation, and/or operation of the elements relative to a user/operator of the device, where "proximal" and "retracting" mean or refer to being closer to or toward the user, and "distal" and "advancing" mean or refer to being farther from or farther away from the user. In some instances, the terms "proximal" and "distal" may be arbitrarily designated to aid in understanding the present disclosure, and these conditions will be readily understood by those skilled in the art. Other related terms, such as "upstream," "downstream," "inflow," and "outflow," refer to the direction of fluid flow within a lumen, such as a body lumen, blood vessel, or device.
The term "limit" may be understood to mean the largest measurement of the stated or identified dimension, unless the limit or dimension in question is preceded by or identified as "minimum" (which may be understood to mean the smallest measurement of the stated or identified dimension). For example, "outer limit" may be understood to mean the largest outer dimension, "radial limit" may be understood to mean the largest radial dimension, "longitudinal limit" may be understood to mean the largest longitudinal dimension, and the like. Each instance of "limit" may be different (e.g., axial, longitudinal, lateral, radial, circumferential, etc.), and will be apparent to one skilled in the art from the respective context of use. In general, "limit" may be considered the largest possible dimension measured according to the intended use, while "minimum limit" may be considered the smallest possible dimension measured according to the intended use. In some cases, the "limit" may be measured generally orthogonally within a plane and/or cross-section, but as will be apparent from the particular context, it may be measured differently, such as, but not limited to, angularly, radially, circumferentially (e.g., along an arc), and so forth.
The terms "unitary" and "unitary" generally refer to one or more elements made or combined from a single structure or base unit/element. Unitary and/or singular elements are intended to exclude structures and/or features formed by assembling or otherwise joining together a plurality of discrete elements.
It should be noted that references in the specification to "one embodiment," "some embodiments," "other embodiments," or the like, indicate that the embodiment or embodiments 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 is submitted that it is within the knowledge of one skilled in the art to effect such 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 still considered to be combinable with or arrangeable with each other to form other additional embodiments or to supplement and/or enrich the described embodiments, as understood by one of ordinary skill in the art.
For clarity, certain identifying numerical terms (e.g., first, second, third, fourth, etc.) may be used throughout the specification and/or claims to name and/or distinguish various described and/or claimed features. It should be understood that the numerical terms are not limiting, but are merely exemplary. In some embodiments, changes and deviations from the numerical terms used previously may be made for brevity and clarity. That is, features identified as "first" elements may be referred to hereafter as "second" elements, "third" elements, etc., or may be omitted entirely, and/or different features may be referred to as "first" elements. The meaning and/or name in each case will be apparent to the skilled practitioner.
The development of thrombi in the Left Atrial Appendage (LAA) during atrial fibrillation may be due to stasis in the LAA. The pooled blood may still be drawn from the left atrium by the left ventricle, but is less effective due to irregular contraction of the left atrium caused by atrial fibrillation. Thus, instead of actively supporting the blood flow by contracting the left atrium and left atrial appendage, the filling of the left ventricle may rely primarily or solely on the pumping effect produced by the left ventricle. However, the contraction of the left atrial appendage may not be synchronized with the cycle of the left ventricle. For example, the contraction of the left atrial appendage may be up to 180 degrees out of phase with the left ventricle, which may create significant resistance to the desired blood flow. Furthermore, the geometry of most left atrial appendages is complex and highly variable, having large irregular surfaces and narrow apertures or openings compared to the depth of the left atrial appendage. These and other aspects, alone or in various combinations, may result in high flow resistance to blood flow out of the left atrial appendage.
In order to reduce the occurrence of thrombosis in the left atrial appendage and prevent thrombi from entering the blood stream from within the left atrial appendage, it may be desirable to develop a medical device and/or an occlusive implant (occluvisoimmi) that isolates the left atrial appendage from the heart and/or circulatory system, thereby reducing the risk of stroke due to thrombolytic substances entering the blood stream from the left atrial appendage. Exemplary medical devices and/or occlusion implants for sealing a left atrial appendage (or other similar opening) are disclosed herein.
Fig. 1 shows an
The delivery system 20 may include a handle 22. The handle 22 may be manipulated by the clinician to guide the distal end region of the delivery catheter 24 to a position adjacent the left
Fig. 1 further illustrates the
In addition, fig. 1 shows that the
Fig. 1 shows that the
Fig. 2 shows an
Further, fig. 2 shows that the
The
In some embodiments, the first occlusion member 14 may be permeable or impermeable to blood and/or other fluids (such as water). In some embodiments, the first occlusion member 14 may include: woven, knitted, and/or knitted materials, fibers, sheet-like materials, fabrics, polymeric membranes, metal or polymeric meshes, porous filter-like materials, or other suitable configurations. In some embodiments, the first occlusion member 14 can prevent thrombus (i.e., blood clots, etc.) from passing through the first occlusion member 14 and exiting the left atrial appendage into the blood stream. In some embodiments, the first occlusion member 14 can promote endothelialization upon implantation effective to remove the left atrial appendage from the circulatory system of the patient. Examples of some suitable, but non-limiting, materials for the first occlusion member 14 are discussed below.
Fig. 2 further illustrates that the
In some examples, the
As shown in fig. 2, the plurality of anchor members 16 disposed along the
While fig. 2 illustrates an
As noted above, it may be desirable to design the
For simplicity, fig. 3 shows a "silhouette" of the occluding implant 10 (described above) in an expanded configuration. In particular, fig. 3 shows the profile of the
As noted above, fig. 3 illustrates the occluding
Fig. 4 illustrates the occluding
Furthermore, while fig. 4 shows
However, to vary the width of the
Fig. 5 shows the
As noted above, while fig. 5 illustrates an
Further, fig. 5 shows the plurality of
As noted above, in some cases, it may be desirable to design the implant 10 (or any of the other implants discussed herein) to maintain a substantially constant radially outward force regardless of the particular configuration (e.g., geometry) that the
Fig. 6 and 7 show the
As shown, fig. 6 and 7 illustrate that the
In addition, fig. 6 shows the
As described above, fig. 7 shows the
Fig. 8 illustrates another
In addition, fig. 8 shows that the
In some embodiments, the second occlusion member 115 can be permeable or impermeable to blood and/or other fluids (such as water). In some embodiments, the second occlusion member 115 can include: woven, knitted, and/or knitted materials, fibers, sheet-like materials, fabrics, polymeric membranes, metal or polymeric meshes, porous filter-like materials, or other suitable configurations. In some embodiments, the second occlusion member 115 can prevent thrombus (i.e., blood clots, etc.) from passing through the second occlusion member 115 and exiting the left atrial appendage into the blood stream. Examples of some suitable, but non-limiting, materials for the second occlusion member 115 are discussed below.
Similar to fig. 6 and 7 above, fig. 9 and 10 show an
As shown, fig. 9 and 10 illustrate that the
Further, fig. 9 shows
As described above, fig. 10 shows the
Fig. 11 illustrates another
Fig. 12 illustrates the occlusion member of fig. 11 in a collapsed (e.g., narrowed) configuration. As can be appreciated from fig. 12, the occlusion disk 256 (described above) may narrow as the
Materials that may be used for the various components of the
In some embodiments, the occlusive implant 10 (and variants, systems, or components thereof disclosed herein) may be made of a metal, metal alloy, polymer (some examples of which are disclosed below), metal-polymer composite, ceramic, combinations thereof, or the like, or other suitable material. Some examples of suitable metals and metal alloys include: stainless steels such as 444V, 444L and 314V stainless steels; low carbon steel; nickel titanium alloys such as linear elastic nitinol and/or superelastic nitinol; other nickel alloys, e.g. nickelChromium molybdenum alloys (e.g., UNS: N06625, such as,625, UNS: n06022 is a sequence of, for example,
C-UNS: n10276, e.g.Others are Alloys, etc.), nickel-copper alloys (e.g., UNS: n04400, the use of, for example,400、400、400, etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: r44035, e.g., MP35-Etc.), nickel-molybdenum alloys (e.g., UNS: n10665 is, for example,ALLOY) Other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten or tungsten alloys, and the like; a cobalt chromium alloy; cobalt-chromium-molybdenum alloys (e.g., UNS: R44003, such as,etc.); platinum-rich stainless steel; titanium; platinum; palladium; gold; combinations thereof or the like; or any other suitable material.As implied herein, in the family of commercially available nickel-titanium or nickel-titanium alloys, the categories designated "linear elastic" or "non-superelastic" may exhibit different and useful mechanical properties, although they may be similar in chemical nature to conventional shape memory and superelastic varieties. Linear elastic and/or non-superelastic nitinol may be distinguished from superelastic nitinol in that linear elastic and/or non-superelastic nitinol does not exhibit a significant "superelastic plateau" or "flag region" (flag region) in its stress/strain curve as does superelastic nitinol. In contrast, in linear elastic and/or non-superelastic nitinol, as the recoverable strain increases, the stress continues to increase in a substantially linear relationship or in some but not necessarily fully linear relationship until plastic deformation begins, or at least increases in a more linear relationship than the superelastic stability level and/or flag region seen in the case of superelastic nitinol. Thus, for the purposes of this disclosure, linear elastic and/or non-superelastic nitinol may also be referred to as "substantially" linear elastic and/or non-superelastic nitinol.
In some cases, the linear elastic and/or non-superelastic nitinol may also be distinguished from superelastic nitinol in that the linear elastic and/or non-superelastic nitinol may receive a strain of up to about 2-5% while remaining substantially elastic (e.g., prior to plastic deformation), while superelastic nitinol may receive a strain of up to about 8% prior to plastic deformation. Both of these materials are distinguishable from other linear elastic materials, such as stainless steel (which may also be distinguished by its composition), which may only accept approximately 0.2 to 0.44 percent strain prior to plastic deformation.
In some embodiments, the linear elastic and/or non-superelastic nickel-titanium alloy is an alloy that does not exhibit any martensite/austenite phase transformations in a large temperature range detectable by Differential Scanning Calorimetry (DSC) and Dynamic Metal Thermal Analysis (DMTA) analysis. For example, in some embodiments, in a linear elastic and/or non-superelastic nickel-titanium alloy, in the range of about-60 degrees Celsius (C.) to about 120℃, there may be no martensite/austenite phase transformation detectable by DSC and DMTA analysis. Thus, the mechanical bending properties of such materials are generally inert to temperature over a wide temperature range. In some embodiments, the mechanical bending properties of linear elastic and/or non-superelastic nickel-titanium alloys at ambient or room temperature are substantially the same as the mechanical properties at body temperature, e.g., because they do not exhibit superelastic stability levels and/or flag regions. In other words, the linear elastic and/or non-superelastic nickel-titanium alloy retains its linear elastic and/or non-superelastic characteristics and/or properties over a wide temperature range.
In some embodiments, the linear elastic and/or non-superelastic nickel-titanium alloy may be in the range of about 50 to about 60 weight percent nickel, with the remainder being substantially 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 available from Furukawa Techno Material, Inc. of Shenkana, Japan. Other suitable materials may include ULTANIUMTM(available from Neo-Metrics) and GUMMETALTM(available from Toyota). In some other embodiments, superelastic alloys, such as superelastic nitinol, may be used to achieve the desired properties.
In at least some embodiments, part or all of the occlusive implant 10 (as well as variations, systems, or components thereof disclosed herein) can also be doped with, made of, or otherwise include a radiopaque material. Radiopaque materials are understood to be materials that are capable of producing relatively bright images on a fluoroscopic screen or other imaging techniques during a medical procedure. Such a relatively bright image aids the user in determining the location of the occluding implant 10 (and variations, systems or components thereof as disclosed herein). Some examples of radiopaque materials may include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloys, polymeric materials loaded with radiopaque fillers, and the like. In addition, other radiopaque marker bands and/or coils may also be incorporated into the design of the occluding implant 10 (as well as variations, systems, or components thereof disclosed herein) to achieve the same effect.
In some embodiments, a degree of Magnetic Resonance Imaging (MRI) compatibility is imparted into the occlusive implant 10 (as well as variants, systems, or components thereof disclosed herein). For example, the occlusion implant 10 (and variations, systems, or components thereof disclosed herein) and/or components or portions thereof may be made of materials that do not significantly distort the image and create significant artifacts (e.g., gaps in the image). For example, certain ferromagnetic materials may not be suitable because they may create artifacts in the MRI images. The occlusion implant 10 (as well as the variations, systems, or components disclosed herein) or portions thereof may also be made of materials that can be imaged by an MRI machine. Some materials exhibiting these properties include, for example, tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS: R44003, such asEtc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: r44035, such as MP35-
Etc.), nitinol, etc., among others.In some embodiments, the occlusive implant 10 (and variants, systems, or components thereof disclosed herein) and/or portions thereof may be made of or include a polymer or other suitable material. Some examples of suitable polymers may include copolymers, polyisobutylene-polyurethanes, Polytetrafluoroethylene (PTFE), Ethylene Tetrafluoroethylene (ETFE), Fluorinated Ethylene Propylene (FEP), polyoxymethylene (POM, e.g., available from DuPont
) Polyether block esters, polyurethanes (e.g., polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyether esters (e.g., available from DSM engineering plastics)) Ether or ester based copolymers (e.g., butylene/poly (alkylene ether) phthalate) and/or other polyester elastomers such as those available from DuPont) Polyamides (e.g. available from Bayer)Or obtainable from Elf Atochem) Elastomeric polyamides, polyamide/ether blocks, polyether block amides (PEBA, for example under the trade nameSold), Ethylene Vinyl Acetate (EVA), silicone, Polyethylene (PE), Marlex high density polyethylene, Marlex low density polyethylene, linear low density polyethylene (e.g., ethylene vinyl acetate copolymer), polyethylene (PE-PE), polyethylene (EVA) Polyesters, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polypropylene terephthalate, polyethylene naphthalate (PEN), Polyetheretherketone (PEEK), Polyimide (PI), Polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), poly (paraphenylene terephthalamide) (e.g.,) Polysulfones, nylons, nylon-12 (e.g., available from EMS American Grilon)) Perfluoro (propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefins, polystyrene, epoxy resins, polyvinylidene chloride (PVdC), poly (styrene-b-isobutylene-b-styrene) (e.g., SIBS and/or SIBS 50A), polycarbonates, ionomers, silicone polyamide copolymers (e.g., from Aortech Biomaterials) Is/are as followsOr from Advan Source Biomaterials) Biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers, polymer/metal composites, and the like thereof. In some embodiments, the sheath (sheath) may be mixed with a Liquid Crystal Polymer (LCP). For example, the mixture may contain up to about 6 percent LCP.In some embodiments, the occlusive implant 10 (and variants, systems, or components thereof disclosed herein) may comprise a woven material. Some examples of suitable woven materials may include synthetic yarns, which may be flat, formed, 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, polypropylene, polyethylene, polyurethanes, polyolefins, polyvinyls, polymethyl acetates, polyamides, naphthalene dicarboxylic derivatives, natural silk, and polytetrafluoroethylene. Furthermore, the at least one synthetic yarn may be a metal yarn or a glass or ceramic yarn or fiber. Useful metal yarns include yarns made of or containing stainless steel, platinum, gold, titanium, tantalum or nickel-cobalt-chromium based alloys. The yarn may further comprise carbon, glass or ceramic fibers. Desirably, the yarns are made of thermoplastic materials including, but not limited to, polyester, polypropylene, polyethylene, polyurethane, polynaphthalene, polytetrafluoroethylene, and the like. The yarns may be of the multifilament, monofilament or staple type. The type and denier of the selected yarn may be selected in a manner that forms a biocompatible and implantable prosthesis, and more particularly, a vascular structure having desired characteristics may be formed.
In some embodiments, the occlusive implant 10 (and variants, 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 antithrombotic agents such as heparin, heparin derivatives, urokinase, and PPack (dextrophenylalanine proline arginine chloromethyl ketone); anti-malignant cell proliferation agents (e.g., enoxaparin, angiopeptin, monoclonal antibodies capable of blocking smooth muscle cell proliferation, hirudin and acetylsalicylic acid); anti-inflammatory agents (e.g., dexamethasone, prednisolone, corticosterone, budesonide, estrogen, sulfasalazine, and mesalamine); anti-tumor/anti-malignant cell proliferation/anti-mitotic agents (e.g., paclitaxel, 5-fluorouracil, cisplatin, vinblastine, vincristine, epothilones, endostatin, angiostatin, and thymidine kinase inhibitors); anesthetics (e.g., lidocaine, bupivacaine, and ropivacaine); anticoagulants (e.g., D-Phe-Pro-Arg chloromethyl ketone, RGD peptide-containing compounds, heparin, antithrombin compounds, platelet receptor antagonists, antithrombin antibodies, antiplatelet receptor antibodies, aspirin, prostaglandin inhibitors, platelet inhibitors, and tick antiplatelet peptides); vascular cell growth promoters (e.g., growth factor inhibitors, growth factor receptor antagonists, transcription activators, and transformation promoters); vascular cell growth inhibitors (e.g., growth factor inhibitors, growth factor receptor antagonists, transcription inhibitors, transformation inhibitors, replication inhibitors, inhibitory antibodies, antibodies to growth factors, bifunctional molecules consisting of growth factors and cytotoxins, bifunctional molecules consisting of antibodies and cytotoxins); a cholesterol lowering agent; a vasodilator; and agents that interfere with endogenous vasoactive mechanisms.
Although the above discussion is generally directed to occlusion implants for use in the left atrial appendage of the heart, the features described above may also be used with other types of medical implants in which a fabric or membrane is attached to a frame or support structure, including, but not limited to, implants for treating 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 occlusion devices (e.g., atrial septal occluders, cerebral aneurysm occluders, peripheral arterial 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. To the extent appropriate, this may include using any of the features of one example embodiment used in other embodiments. The scope of the present disclosure is, of course, defined by the language in which the appended claims are expressed.
- 上一篇:一种医用注射器针头装配设备
- 下一篇:栓塞材料