In numerous locations of the human anatomy, a primary bodily conduit (e.g., primary blood vessel) is connected with one or more secondary bodily conduits (e.g., branch or peripheral vessels) that branch off from the primary bodily conduit. In some cases the secondary bodily conduits convey fluid into the primary bodily conduit (e.g., venous conduits), while in other cases the secondary bodily conduits convey fluid away from the primary bodily conduit (e.g., arterial conduits).
The human vasculature includes many examples of primary bodily conduits that have secondary branches. One example of a primary bodily conduit is the aorta. In the abdominal aorta, a plurality of arteries branch off from the aorta.
Bodily conduits and/or circulatory (or other bodily) systems with which they are associated may suffer from various diseases, defects and conditions, or may otherwise benefit from augmentation using one or more implantable prosthetic conduits, including grafts, stent-grafts, filters, anastomosis devices, prosthetic valves, and others. Generally, such implantable conduits have tubular forms configured to convey fluid in the body.
Disclosed herein are examples of an implantable device.
According to one example, (“Example 1”), an implantable device includes a tubular member having a first end and a second end, the tubular member forming a primary lumen having a first opening at the first end of the tubular member and a second opening at the second end of the tubular member, the tubular member includes a column positioned within the primary lumen and forming a secondary lumen, the tubular member defining a plurality of apertures opening into the secondary lumen at positions longitudinally between the first end and the second end of the tubular member, the column having a column opening; and a stent member supporting the tubular member.
According to another example (“Example 2”), further to Example 1, the tubular member includes a first graft member defining the primary lumen and a second graft member coupled to the first graft member forming the column and defining the secondary lumen between the first and second graft members.
According to another example (“Example 3”), further to Example 2, the secondary lumen opens into the primary lumen at the proximal opening of the secondary lumen.
According to another example (“Example 4”), further to any of the preceding Examples, the secondary lumen is collapsible.
According to another example (“Example 5”), further to any of the preceding Examples, the secondary lumen is unsupported by a stent.
According to another example (“Example 6”), further any of the preceding Examples, the stent member includes a plurality of stent rings spaced longitudinally along the tubular member.
According to another example (“Example 7”), further to Example 6, each of the plurality of apertures is separated from each other by at least one of the plurality of stent rings.
According to another example (“Example 8”), further to any of the preceding Examples, each aperture of the plurality of apertures includes a circular shape or a shape defining a rounded portion and a substantially flat portion.
According to another example (“Example 9”), further to any of the preceding Examples, the tubular member includes a plurality of secondary lumens extending longitudinally along at least a portion of the tubular member and circumferentially spaced from each other.
According to another example (“Example 10”), further to any of the preceding Examples, the implantable device further includes a constraining member receiver positioned surrounding at least a portion of the stent member.
According to another example (“Example 11”), further to any of the preceding Examples, the tubular member includes a scallop at the first end.
According to another example (“Example 12”), further to any of the preceding Examples, the secondary lumen extends along a secondary lumen axis that extends longitudinally at an angle greater than zero relative to an axis of the primary lumen.
According to another example (“Example 13”), an implantable device includes a tubular member having a first end and a second end, the tubular member forming a primary lumen having a first opening at the first end of the tubular member and a second opening at the second end of the tubular member, the tubular member including a plurality of columns each defining a secondary lumen, each column of the plurality of columns being circumferentially spaced from each other, each secondary lumen having an aperture defined through the tubular member at a position between the first end and the second end and having a column opening proximate the second end of the tubular member, each column being operable to collapse under hydrostatic pressure; and a stent member supporting the tubular member.
According to another example (“Example 14”), a delivery system includes an implantable device including a main body and a side branch, the main body including a tubular member and a stent member supporting the tubular member, the tubular member forming a primary lumen having a first opening and a second opening, the tubular member forming a secondary lumen having an aperture defined through the tubular member and having a proximal opening proximal the second opening of the tubular member; an elongate member having a first end and a second end, the main body of the implantable device being positioned at the first end of the elongate member, the elongate member defining a delivery lumen extending along at least a portion of a longitudinal length of the elongate member and through which the side branch is operable to be delivered; a catheter olive positioned at the first end of the elongate member such that the main body of the implantable device is positioned longitudinally between a leading tip of the catheter olive and the second end of the elongate member; a constraining member positioned about the main body and constraining the main body to a delivery configuration; and a secondary constraining member positioned about the stent of the main body, the secondary constraining member operable to constrain the main body to a partially constrained configuration.
According to another example (“Example 15”), further to Example 14, the delivery system further includes a guide member extending from the delivery lumen of the elongate member, through the secondary lumen of the tubular member from the proximal opening and through the aperture, and coupled to the catheter olive.
According to another example (“Example 16”), further to Example 15, the delivery system further includes an exchange catheter coupled to the guide member and operable to be advance along the guide member.
According to another example (“Example 17”), further to Example 16, the delivery system further includes a first guidewire operable to be delivered through the exchange catheter; a curved catheter operable to be advanced over the first guidewire; and a second guidewire that is stiffer than the first guidewire, the second guidewire operable to be advanced through the curved catheter, the side branch operable to be advanced to a target site along the second guidewire.
According to another example (“Example 18”), a delivery system includes an implantable device including a main body and a side branch, the main body including tubular member and stent member supporting the tubular member, the tubular member forming a primary lumen having a first opening and a second opening, the tubular member including a column defining a secondary lumen and having an aperture defined through the tubular member and having a column opening proximal the second opening of the tubular member; an elongate member having a first end and a second end, the main body of the implantable device being positioned proximal to the first end of the elongate member, the elongate member defining a lumen through which the side branch is operable to be delivered; a catheter olive positioned at the first end of the elongate member such that the main body of the implantable device is positioned longitudinally between a leading tip of the catheter olive and the second end of the elongate member; a constraining member positioned about the main body and constraining the main body to a delivery configuration; and a guide member extending from the lumen of the elongate member, through the secondary lumen of the tubular member from the proximal opening and through the aperture, and coupled to the catheter olive.
According to another example (“Example 19”), the delivery system further includes a secondary constraining member positioned about the stent of the main body, the secondary constraining member operable to constrain the main body to a partially constrained configuration.
According to another example (“Example 20”), further to Example 19, the stent member of the main body includes a plurality of stent rings, wherein the secondary constraining member includes a plurality of wires, wherein a wire of the plurality of wires corresponds to a corresponding stent ring of the plurality of stent rings.
According to another example (“Example 21”), a method of delivering an implantable device to a target site including a main vessel and side branch vessels, the method including advancing a main body of the implantable device to the main vessel of the target site, the main body being constrained by a constraining member about an elongate member proximate a first end of the elongate member, the main body including a tubular member having a first end and a second end, the tubular member forming a primary lumen having a first opening at the first end of the tubular member and a second opening at the second end of the tubular member, the tubular member having a plurality of columns each defining a secondary lumens extending along at least a portion of a longitudinal length of the tubular member and each having a plurality of apertures defined through the tubular member at positions between the first end and the second end of the tubular member, each secondary lumen having a column opening proximal the second end of the tubular member, the tubular member including a scallop at the first end of the tubular member, the main body including a stent member supporting the tubular member and operable to be configured in a delivery configuration and in a deployed configuration; positioning the scallop of the tubular member proximate a side branch vessel; releasing the main body from the constraining member such that the main body is operable to be expanded from a delivery configuration to an expanded configuration; advancing an exchange catheter toward a side branch vessel, the exchange catheter advanced along a guide member extending from the elongate member, through one of the plurality of secondary lumens of the tubular member from the proximal opening and through a first end aperture of the plurality apertures, and releasably coupled to a catheter olive at the first end of the elongate member; introducing a first guidewire through the exchange catheter such that first guidewire extends beyond the first end aperture of the secondary lumen; retracting the exchange catheter away from around the first guidewire; selecting a target aperture of the plurality of apertures through which the side branch is delivered, including retracting the first guidewire is positioned at or through the target aperture; exchanging the first guidewire with a second, stiffer guidewire; advancing the side branch to a side branch vessel via the second guidewire; and deploying the side branch at the side branch vessel.
The foregoing examples are just that, and should not be read to limit or otherwise narrow the scope of any of the inventive concepts otherwise provided by the instant disclosure. While multiple examples are disclosed, still other embodiments will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative examples. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature rather than restrictive in nature.
The accompanying drawings are included to provide a further understanding of the disclosure and are incorporated in and constitute a part of this specification, illustrate embodiments, and together with the description serve to explain the principles of the disclosure.
Persons skilled in the art will readily appreciate that various aspects of the present disclosure can be realized by any number of methods and apparatuses configured to perform the intended functions. It should also be noted that the accompanying drawing figures referred to herein are not necessarily drawn to scale, but may be exaggerated to illustrate various aspects of the present disclosure, and in that regard, the drawing figures should not be construed as limiting.
This disclosure is not meant to be read in a restrictive manner. For example, the terminology used in the application should be read broadly in the context of the meaning those in the field would attribute such terminology.
With respect to terminology of inexactitude, the terms “about” and “approximately” may be used, interchangeably, to refer to a measurement that includes the stated measurement and that also includes any measurements that are reasonably close to the stated measurement. Measurements that are reasonably close to the stated measurement deviate from the stated measurement by a reasonably small amount as understood and readily ascertained by individuals having ordinary skill in the relevant arts. For example, such deviations may be attributable to measurement error or minor adjustments made to optimize performance. In the event it is determined that individuals having ordinary skill in the relevant arts would not readily ascertain values for such reasonably small differences, the terms “about” and “approximately” and similar terminology can be understood to mean plus or minus 10% of the stated value.
Various aspects of the present disclosure are directed to apparatuses, systems, and methods that include an implantable device. The implantable device may be arranged within a patient for supporting one or more fluid passageway(s). The implantable device may be positioned in a main portion of fluid passageway (e.g., artery, vein, CSF passageway, and so forth) and include side branches that extend into side branch passageways within the patient. In certain instances, the implantable device may be a graft or stent graft that is arranged within the vasculature. The apparatuses, systems, and methods may be used in improving or assisting circulatory function and specifically that of side branches (e.g., leading to critical organs such as the kidneys). In one example, a patient may have an abdominal aortic aneurysm (“AAA”). The AAA may develop near the renal arteries and/or extend into the renal arteries. An implantable device may be used to help prevent enlargement and rupturing of the aneurysm while maintaining perfusion of the main artery and one or more side branch arteries, such as the renal arteries.
As shown in
In some embodiments, the tubular member 20 includes a first graft member 41 defining the primary lumen 26 and a second graft member 42 coupled to the first graft member 41 to form the column 28 defining the secondary lumen 30 between the first graft member 41 and the second graft member 42. For example, the first graft member 41 includes graft material formed in the shape of a tube to define the primary lumen 26. And, the second graft member 42 optionally includes graft material that is coupled to the first graft member 41 (e.g., via boding, adhesive, or by otherwise being coupled together) to form the secondary lumen 30. The graft materials of the first and second graft members 41, 42 may be the same material or different materials as desired. Though some materials may provide certain advantages over others, a variety of suitable graft materials may be implemented, and generally any suitable graft material may be implemented including those materials discussed herein.
In some embodiments the secondary lumen 30 extends at least partially along a longitudinal length of the main body 12. The secondary lumen 30 of the column 28 opens into the primary lumen 26 at the proximal opening of the secondary lumen 30. In some embodiments, the column 28 extends to the second end 24 of the tubular member 20 such that the column opening 34 is positioned at or coplanar with the second opening 25 of the tubular member 20. In other embodiments, the column 28 extends toward the second end 24 of the tubular member 20 such that the column opening 34 is longitudinally spaced from the second opening 25 of the tubular member 20. In embodiments including a plurality of columns 28, the column openings 34 may be positioned at the same longitudinal length across, or in different terms, at the same longitudinal position along, the tubular member 20 or they may be staggered at two or more longitudinally-spaced positions along the length of the tubular member 20.
In some embodiments, the column 28, and consequently the secondary lumen 30 are collapsible. For example, the column 28 may be unsupported by a stent member, although supported, collapsible embodiments are also contemplated. Lack of a support, or a suitably configured support, may allow the column 28 to be collapsed (radially collapsed) to seal the aperture 32 and limit the leaking or other passing of fluids (e.g., blood) through the aperture 32. In some embodiments, the pressure (e.g., hydrostatic pressure, fluid pressure gradients, and/or pressure exerted by fluids in motion) that is exerted by the fluid collapses the column 28 such that the column coats or seals against the tubular member 20 to limit flow through the secondary lumen 30 and consequently the aperture 32.
As illustrated in
Referring again to
As illustrated in
Referring to
In some embodiments, the main body 12 may include a plurality of columns 28. For instance, the main body 12 may include two columns 28 that are circumferentially spaced from each other in order to deploy two side branches 14 into the side branch lumens of the patient's anatomy. Furthermore, the main body 12 may include a plurality of columns 28 that are associated with each side branch lumen of the patient's anatomy. For example, if the main body 12 is to be deployed in the abdominal aorta and the side branches 14 are to be deployed into the renal arteries, each patient may have a various positions circumferentially at which the renal arteries enter the aorta.
By having a plurality of columns 28 through which each side branch 14 may be deployed, the surgeon may select the appropriate columns 28 that best conform to the patient's native anatomy without applying torsion to the vessels when the implantable device 10 is deployed. Thus, in one example, the main body 12 may include three columns 28 on one circumferential side of the tubular member 20 and three more columns 28 on an opposite circumferential side of the tubular member 20. Each column 28 is circumferentially spaced from the adjacent column 28 about the circumference of the tubular member 20. It is contemplated that any number of columns 28 and the spacing of the columns 28 may be implemented, including one, two, three, four, five, six, seven, eight, or more columns 28 which may be spaced equally or variably about the circumference of the tubular member 20. It is further contemplated that the specific spacing may be determined by surveying the average circumferential spacing of side branches for a particular implementation in a sample population of patients to determine the spacing of the columns 28. Circumferential spacing of the column 28 allows for clocking of the main body 12 within the patient's anatomy with increased positions for appropriately positioning the side branches 14 into the side branch vessels. As used herein, the term “clocking” refers to the ability to position features at a desired location about a circumference of an object. This ability to clock the one or more columns 28 can be further advantageous for use with visualization, for example when the procedure is being performed via fluoroscopy. This simplifies placement by providing several entry points when dealing with the two-dimensional planes shown by visualization techniques and for parallax associated with such visualization. In some embodiments, the columns 28 may be irregularly spaced about the circumference of the main body 12 (e.g., non-uniform spacing between the columns 28). In some embodiments not shown, the column 28 extends longitudinally and at angle greater than zero relative to the main body 12 longitudinal axis. For example, the secondary lumen 30 extends along a secondary lumen axis that extends longitudinally at an angle greater than zero relative to an axis of the primary lumen 26 (e.g., helically about the main body 12).
Referring again to
In some embodiments, the tubular member 20 may include a scallop 52 at the first end 22. The scallop 52 is a facilitates placement of the tubular member 20 in a lumen including a side branch lumen that does not need a prosthetic side branch deployed. For example, when the implantable device 10 is positioned in the abdominal aorta and the superior mesenteric artery does not need a side branch 14 deployed therein, the scallop 52 may be positioned over the entrance into the superior mesenteric artery without blocking or restricting blood perfusion therethrough (see
Referring now to
The delivery system 100 is operable to facilitate placement of the implantable device 10 at a branched lumen, allow for at least partial collapse and re-expansion of the main body 12 of the implantable device 10 once deployed, and fenestration of the main body 12 with a side branch 14 for implantation of the side branch 14 at the side branch lumen.
The delivery system 100 is provided with an elongate member 110 (e.g., a delivery catheter), a catheter olive 130, a constraining member 150, a secondary constraining member 170, and a guide member 190. The delivery system may also include a delivery handle 200 for operating, controlling, and otherwise manipulating the delivery system 100 and its various components.
The elongate member includes a first end 112 and a second end 114, the main body 12 of the implantable device 10 being positioned at the first end 112 of the elongate member 110. Referring to
A catheter olive 130 positioned at the first end 112 of the elongate member 110 such that the main body 12 of the implantable device 10 is positioned longitudinally between the catheter olive 130 and the second end 114 of the elongate member 110. Although an embodiment of the catheter olive 130 is depicted in the drawings, it is in the scope of the disclosure that any catheter olive 130 may be implemented within the scope of this disclosure. The catheter olive 130 may be implement to atraumatically advance the delivery system 100 through the patient and to dilate the surrounding anatomy where appropriate. For example, the catheter olive may include a leading tip which is advanced first through the patient's anatomy. Referring to
A constraining member 150 is positioned about the main body 12 and constraining the main body to a delivery configuration. Any number of constraining members 150 may be implemented, and may include a knit, tubular, or any other releasable structure that can be selectively released or actuated to allow expansion of the device. Such structures include those discussed in U.S. Pat. No. 6,224,627 to Armstrong granted Jun. 15, 1998 and U.S. Pat. No. 7,753,945 to Bruun granted Jul. 13, 2010, the content of which is herein expressly incorporated by reference in their entireties. The constraining member 150 is removed and the main body 12 is operable to expand (e.g., self-expanding) or be expanded (e.g., balloon expandable) to an expanded configuration. The constraining member 150 may be controlled (e.g., released) from the main body 12 via a deployment line (not shown) extending through the constraining member lumen 120.
A secondary constraining member 170 positioned about the stent member 40 of the main body 12. In those embodiments including a plurality of stent rings 44, the delivery system 100 may include a plurality of secondary constraining members 170 corresponding to each stent ring 44. Referring to
The secondary constraining members 170 may pass through the tubular member 20 in some embodiments. In order to limit leakage through the tubular member once removed, the secondary constraining members 170 may pass through the tubular member 20 in a column 28 (see
The secondary constraining members 170 may be implemented in order to pull the tubular member 20 away from the vessel wall in order to reposition the main body 12, to allow perfusion through the side branch vessels while the placement and delivery of the implantable device 10 is still being performed, or for visualization of the main body 12 within the vessel (e.g., via fluoroscopy). For example, the main body 12 may have a first diameter corresponding to the delivery configuration and a second diameter corresponding to the deployed configuration, the second diameter being greater than the first configuration. When the secondary constraining members 170 are activated to constrain the main body 12, the main body may include an intermediate diameter that is less than the second diameter and greater than the first diameter and corresponding to the partially constrained configuration.
Referring to
Referring to
More specifically,
Referring now to
With further reference to
It is understood that the procedure can be implemented in a de novo procedure or as a reintervention. The method is largely the same for both procedures. As previously discussed, the implantable device 10 may be implemented with various other implantable components for engaging other anatomy such as branched device and so forth (as seen in
A variety of material sets may be implemented for the graft members, including known vascular graft and stent graft materials. Polymers, biodegradable and natural materials can be used for specific applications. And, a variety of manufacturing techniques may be implemented to form the graft members, including extruding, coating, wrapping, combinations thereof, and others.
A biocompatible material for the graft components, discussed herein, may be used. In certain instances, the graft may include a fluoropolymer, such as a polytetrafluoroethylene (PTFE) polymer or an expanded polytetrafluoroethylene (ePTFE) polymer. In some instances, the graft may be formed of, such as, but not limited to, a polyester, a silicone, a urethane, a polyethylene terephthalate, or another biocompatible polymer, or combinations thereof. In some instances, bioresorbable or bioabsorbable materials may be used, for example a bioresorbable or bioabsorbable polymer. In some instances, the graft can include Dacron, polyolefins, carboxy methylcellulose fabrics, polyurethanes, or other woven, non-woven, or film elastomers.
Examples of suitable synthetic polymers include, but are not limited to nylon, polyacrylamide, polycarbonate, polyformaldehyde, polymethylmethacrylate, polytetrafluoroethylene, polytrifluorochlorethylene, polyvinylchloride, polyurethane, elastomeric organosilicon polymers, polyethylene, polypropylene, polyurethane, polyglycolic acid, polyesters, polyamides, their mixtures, blends and copolymers are suitable as a graft member. In one embodiment, the graft is made from a class of polyesters such as polyethylene terephthalate including DACRON® and MYLAR® and polyaramids such as KEVLAR®, polyfluorocarbons such as polytetrafluoroethylene (PTFE) with and without copolymerized hexafluoropropylene (TEFLON® or GORE-TEX®), and porous or nonporous polyurethanes. In another embodiment, the graft comprises expanded fluorocarbon polymers (especially PTFE) materials. Included in the class of preferred fluoropolymers are polytetrafluoroethylene (PTFE), fluorinated ethylene propylene (FEP), copolymers of tetrafluoroethylene (TFE) and perfluoro (propyl vinyl ether) (PFA), homopolymers of polychlorotrifluoroethylene (PCTFE), and its copolymers with TFE, ethylenechlorotrifluoroethylene (ECTFE), copolymers of ethylene-tetrafluoroethylene (ETFE), polyvinylidene fluoride (PVDF), and polyvinylfluoride (PVF). Especially preferred, because of its widespread use in vascular prostheses, is ePTFE. In another embodiment, the graft comprises a combination of the materials listed above. In another embodiment, the graft is substantially impermeable to bodily fluids. The substantially impermeable graft can be made from materials that are substantially impermeable to bodily fluids or can be constructed from permeable materials treated or manufactured to be substantially impermeable to bodily fluids (e.g. by layering different types of materials described above or known in the art). In one embodiment, the main body and branch members, as described above, are made from any combinations of the materials above. In another embodiment, the main body and branch members, as described above, comprise ePTFE.
The stents, as described, may be provided in the form of a series of rings arranged generally coaxially along the graft body. In some embodiments, as described, may be generally cylindrical when restrained and/or when unrestrained and comprise helically arranged undulations having plurality of helical turns. The undulations preferably are aligned so that they are “in-phase” with each other. More specifically, undulations comprise apices in opposing first and second directions. When the undulations are in-phase, apices in adjacent helical turns are aligned so that apices can be displaced into respective apices of a corresponding undulation in an adjacent helical turn. In one embodiment, the undulations have a sinusoidal shape. In another embodiment, the undulations are U-shaped. In another embodiment, the undulations are V-shaped. In another embodiment, the undulations are ovaloid shaped.
In various embodiments, the stent can be fabricated from a variety of biocompatible materials including commonly known materials (or combinations of materials) used in the manufacture of implantable medical devices. Typical materials include 316L stainless steel, cobalt-chromium-nickel-molybdenumiron alloy (“cobalt-chromium”), other cobalt alloys such as L605, tantalum, nitinol, or other biocompatible metals. In one embodiment, any stent-graft described herein is a balloon expandable stent-graft. In another embodiment, any stent-graft described herein is a self-expanding stent-graft. In another embodiment, the stent is a wire wound stent. In another embodiment, the wire wound stent includes undulations, or a repeating, undulating pattern of apices.
The wire wound stent can be constructed from a reasonably high strength material, e.g., one which is resistant to plastic deformation when stressed. In one embodiment, the stent member comprises a wire which is helically wound around a mandrel having pins arranged thereon so that the helical turns and undulations can be formed simultaneously, as described below. Other constructions also may be used. For example, an appropriate shape may be formed from a flat stock and wound into a cylinder or a length of tubing formed into an appropriate shape or laser cutting a sheet of material. In another embodiment, said stent is made from a super-elastic alloy. There are a variety of disclosures in which super-elastic alloys such as nitinol are used in stents.
A variety of materials variously metallic, super elastic alloys, such as Nitinol, are suitable for use in these stents. Primary requirements of the materials are that they be suitably springy even when fashioned into very thin sheets or small diameter wires. Various stainless steels which have been physically, chemically, and otherwise treated to produce high springiness are suitable as are other metal alloys such as cobalt chrome alloys (e.g., ELGILOY®), platinum/tungsten alloys, and especially the nickel-titanium alloys generically known as “nitinol”.
Nitinol is especially preferred because of its “super-elastic” or “pseudo-elastic” shape recovery properties, i.e., the ability to withstand a significant amount of bending and flexing and yet return to its original form without permanent deformation. These metals are characterized by their ability to be transformed from an austenitic crystal structure to a stress-induced martensitic structure at certain temperatures, and to return elastically to the austenitic shape when the stress is released. These alternating crystalline structures provide the alloy with its super-elastic properties.
Other suitable stent materials include certain polymeric materials, particularly engineering plastics such as thermotropic liquid crystal polymers (“LCP's”). These polymers are high molecular weight materials which can exist in a so-called “liquid crystalline state” where the material has some of the properties of a liquid (in that it can flow) but retains the long range molecular order of a crystal. The term “thermotropic” refers to the class of LCP's which are formed by temperature adjustment. LCP's may be prepared from monomers such as p,p′-dihydroxy-polynuclear-aromatics or dicarboxy-polynuclear-aromatics. The LCP's are easily formed and retain the necessary interpolymer attraction at room temperature to act as high strength plastic artifacts as are needed as a foldable stent. They are particularly suitable when augmented or filled with fibers such as those of the metals or alloys discussed below. It is to be noted that the fibers need not be linear but may have some preforming such as corrugations which add to the physical torsion enhancing abilities of the composite.
Any of a variety of bio-active agents may be implemented with any of the foregoing. For example, any one or more of (including portions thereof) the device 10 may comprise a bio-active agent. Bio-active agents can be coated onto one or more of the foregoing features for controlled release of the agents once the device 10 is implanted. Such bio-active agents can include, but are not limited to, thrombogenic agents such as, but not limited to, heparin. Bio-active agents can also include, but are not limited to agents such as anti-proliferative/antimitotic agents including natural products such as vinca alkaloids (e.g., vinblastine, vincristine, and vinorelbine), paclitaxel, epidipodophyllotoxins (e.g., etoposide and teniposide), antibiotics (e.g., dactinomycin (actinomycin D), daunorubicin, doxorubicin, and idarubicin), anthracyclines, mitoxantrone, bleomycins, plicamycin (mithramycin) and mitomycin, enzymes (e.g., L-asparaginase which systemically metabolizes L-asparagine and deprives cells which do not have the capacity to synthesize their own asparagine); antiplatelet agents such as G(GP) IIb/IIIa inhibitors and vitronectin receptor antagonists; anti-proliferative/antimitotic alkylating agents such as nitrogen mustards (e.g., mechlorethamine, cyclophosphamide and analogs, melphalan, chlorambucil), ethylenimines and methylmelamines (e.g., hexamethylmelamine and thiotepa), alkyl sulfonates-busulfan, nitrosoureas (e.g., carmustine (BCNU) and analogs, streptozocin), trazenes-dacarbazinine (DTIC); anti-proliferative/antimitotic antimetabolites such as folic acid analogs (e.g., methotrexate), pyrimidine analogs (e.g., fluorouracil, floxuridine, and cytarabine), purine analogs and related inhibitors (e.g., mercaptopurine, thioguanine, pentostatin and 2-chlorodeoxyadenosine {cladribine}); platinum coordination complexes (e.g., cisplatin and carboplatin), procarbazine, hydroxyurea, mitotane, aminoglutethimide; hormones (e.g., estrogen); anti-coagulants (e.g., heparin, synthetic heparin salts and other inhibitors of thrombin); anti-platelet agents (e.g., aspirin, clopidogrel, prasugrel, and ticagrelor); vasodilators (e.g., heparin, aspirin); fibrinolytic agents (e.g., plasminogen activator, streptokinase, and urokinase), aspirin, dipyridamole, ticlopidine, clopidogrel, abciximab; antimigratory agents; antisecretory agents (e.g., breveldin); anti-inflammatory agents, such as adrenocortical steroids (e.g., cortisol, cortisone, fludrocortisone, prednisone, prednisolone, 6α-methylprednisolone, triamcinolone, betamethasone, and dexamethasone), non-steroidal agents (e.g., salicylic acid derivatives, such as aspirin); para-aminophenol derivatives (e.g., acetaminophen); indole and indene acetic acids (e.g., indomethacin, sulindac, and etodalac), heteroaryl acetic acids (e.g., tolmetin, diclofenac, and ketorolac), arylpropionic acids (e.g., ibuprofen and derivatives), anthranilic acids (e.g., mefenamic acid and meclofenamic acid), enolic acids (e.g., piroxicam, tenoxicam, phenylbutazone, and oxyphenthatrazone), nabumetone, gold compounds (e.g., auranofin, aurothioglucose, and gold sodium thiomalate); immunosuppressives (e.g., cyclosporine, tacrolimus (FK-506), sirolimus (rapamycin), azathioprine, and mycophenolate mofetil); angiogenic agents (e.g., vascular endothelial growth factor (VEGF)), fibroblast growth factor (FGF); angiotensin receptor blockers; nitric oxide donors; anti-sense oligonucleotides and combinations thereof; cell cycle inhibitors, m TOR inhibitors, growth factor receptor signal transduction kinase inhibitors; retinoids; cyclin/CDK inhibitors; HMG co-enzyme reductase inhibitors (statins); and protease inhibitors.
Numerous characteristics and advantages of the present invention have been set forth in the preceding description, including preferred and alternate embodiments together with details of the structure and function of the invention. The disclosure is intended as illustrative only and as such is not intended to be exhaustive. It will be evident to those skilled in the art that various modifications may be made, especially in matters of structure, materials, elements, components, shape, size and arrangement of parts within the principals of the invention, to the full extent indicated by the broad, general meaning of the terms in which the appended claims are expressed. To the extent that these various modifications do not depart from the spirit and scope of the appended claims, they are intended to be encompassed therein. In addition to being directed to the embodiments described above and claimed below, the present invention is further directed to embodiments having different combinations of the features described above and claimed below.
It will be apparent to those skilled in the art that various modifications and variations can be made in the embodiments without departing from the scope of the disclosure. Thus, it is intended that the embodiments cover the modifications and variations of this invention provided they come within the scope of the appended claims and their equivalents.
This application is a national phase application of PCT Application No. PCT/US2022/017251, internationally filed on Feb. 22, 2022, which claims the benefit of Provisional Application No. 63/176,031, filed Apr. 16, 2021, which are incorporated herein by reference in their entireties for all purposes.
Filing Document | Filing Date | Country | Kind |
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PCT/US2022/017251 | 2/22/2022 | WO |
Number | Date | Country | |
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63176031 | Apr 2021 | US |