Implantable vascular device
First Claim
1. An implantable valve for a bodily passage of tubular shape, comprising:
- a self-expanding support frame having a first end and a second end, said support frame configured for expansion to conform to a wall of the bodily passage, said support frame having only two, three or four bends occurring at each end of said first end and said second end of said support frame, said bends configured to provide outward radial force for expansion of said self-expanding frame to anchor the implantable valve to the wall of the bodily passage, said support frame when expanded providing a plurality of side elements each defining a path extending at least partially longitudinally along the wall and at least partially circumferentially around the wall,only two, three or four leaflets, each leaflet having a body extending from a wall-engaging outer edge to an inner edge proximate a corresponding inner edge of at least one other leaflet of the plurality of leaflets,the inner edges of said leaflets cooperable to define an opening therebetween to permit fluid flow in a first direction along the bodily passage, and further cooperable to engage each other sufficiently to restrict fluid flow in a second direction opposing the first direction,the outer edge of each one of the leaflets includes an attachment extending along at least selected ones of the side elements such that the outer edge is adapted to resiliently and sealingly engage the wall of the bodily passage along said path, wherein said attachment includes an amount of the outer edge of the leaflet wrapped around a corresponding side element to which the outer edge is attached so as to provide an amount of material from which the leaflet is made occurring on an outer side of said corresponding side element, each leaflet extending along said bodily passage away from the inner edges thereof in said second direction to form a curved structure for trapping fluid against the inner wall of the bodily passage in response to fluid flow in said second direction so as to cause said inner edges of said leaflets to engage one another sufficiently to restrict fluid flow in said second direction;
wherein the implantable valve further includes at least one barb to anchor the implantable valve to the wall of the bodily passage;
wherein the number of leaflets of said implantable valve is equal to the number of bends occurring at each end of the support frame; and
wherein said support frame is adapted to assume a plurality of configurations, a first configuration of the plurality of configurations being a generally flat plane.
3 Assignments
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Accused Products
Abstract
A multiple-sided medical device comprises a frame comprising wire or other resilient material and having a series of bends and interconnecting sides. The device has both a flat configuration and a second, folded configuration which a generally serpentine shape. The device is pushed from a delivery catheter into the lumen of a duct or vessel and may include one or more barbs for anchoring purposes. A full or partial covering of fabric or other flexible material such as DACRON, PTFE, or a collagen-based material such as small intestinal submucosa (SIS), may be sutured or attached to the frame to form an occlusion device, a stent graft, or an implantable, intraluminal valve such as for correcting incompetent veins in the lower legs and feet.
430 Citations
25 Claims
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1. An implantable valve for a bodily passage of tubular shape, comprising:
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a self-expanding support frame having a first end and a second end, said support frame configured for expansion to conform to a wall of the bodily passage, said support frame having only two, three or four bends occurring at each end of said first end and said second end of said support frame, said bends configured to provide outward radial force for expansion of said self-expanding frame to anchor the implantable valve to the wall of the bodily passage, said support frame when expanded providing a plurality of side elements each defining a path extending at least partially longitudinally along the wall and at least partially circumferentially around the wall, only two, three or four leaflets, each leaflet having a body extending from a wall-engaging outer edge to an inner edge proximate a corresponding inner edge of at least one other leaflet of the plurality of leaflets, the inner edges of said leaflets cooperable to define an opening therebetween to permit fluid flow in a first direction along the bodily passage, and further cooperable to engage each other sufficiently to restrict fluid flow in a second direction opposing the first direction, the outer edge of each one of the leaflets includes an attachment extending along at least selected ones of the side elements such that the outer edge is adapted to resiliently and sealingly engage the wall of the bodily passage along said path, wherein said attachment includes an amount of the outer edge of the leaflet wrapped around a corresponding side element to which the outer edge is attached so as to provide an amount of material from which the leaflet is made occurring on an outer side of said corresponding side element, each leaflet extending along said bodily passage away from the inner edges thereof in said second direction to form a curved structure for trapping fluid against the inner wall of the bodily passage in response to fluid flow in said second direction so as to cause said inner edges of said leaflets to engage one another sufficiently to restrict fluid flow in said second direction; wherein the implantable valve further includes at least one barb to anchor the implantable valve to the wall of the bodily passage; wherein the number of leaflets of said implantable valve is equal to the number of bends occurring at each end of the support frame; and wherein said support frame is adapted to assume a plurality of configurations, a first configuration of the plurality of configurations being a generally flat plane. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13)
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14. A bi-leaflet implantable valve for a bodily passage of tubular shape, comprising:
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a support frame having a first end and a second end, said support frame having only two bends at each of said first end and said second end, said support frame configured for expansion to conform to a wall of the bodily passage, said support frame when expanded providing a plurality of side elements each defining a path extending at least partially longitudinally along the wall and at least partially circumferentially around the wall, only two leaflets, each leaflet comprising an extracellular collagen matrix material, each leaflet having a body extending from a wall-engaging outer edge to an inner edge proximate a corresponding inner edge of the other leaflet, the inner edges of said leaflets cooperable to define an opening therebetween to permit fluid flow in a first direction along the bodily passage, and further cooperable to engage each other sufficiently to restrict fluid flow in a second direction opposing the first direction, the outer edge of each one of the leaflets attached along one side element of said plurality of side elements and thereby adapted to directly engage the wall of the bodily passage therearound and provide ingrowth of adjacent native tissue into the extracellular collagen matrix material, wherein the outer edge of each one of the plurality of leaflets is wrapped around a corresponding side element to which the outer edge is attached so as to provide an amount of material from which the leaflet is made occurring on an outer side of said corresponding side element; and wherein the implantable valve includes at least one barb to anchor the implantable valve to the wall of the bodily passage. - View Dependent Claims (15, 16, 17, 18)
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19. An implantable valve for a bodily passage of tubular shape, comprising:
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a frame that includes a first end and a second end and a plurality of legs, each of the legs originating from a pair of bends located about the first end of the frame, and extending in an opposite direction therefrom, each of the plurality of legs terminating at the second end of the frame opposite the first end such that the plurality of legs generally assume a serpentine configuration along the circumference of a bodily passage when situated therein, a plurality of leaflets, each leaflet comprising a covering that includes one or more flexible materials, the leaflet including a body that comprises a wall-engaging outer edge and an inner edge, the outer edge at least partially attached to, and reinforced by one of the plurality of legs, the outer edge and the associated leg adapted to sealingly engage the inner wall of the bodily passage, and wherein the outer edge is wrapped around a corresponding leg to which the outer edge is attached so as to provide an amount of material from which the leaflet is made occurring on an outer side of said corresponding leg; wherein the body of the leaflet extends inward from the wall of the bodily passage and extending toward the first end of the implantable valve where it terminates at the inner edge, the body and inner edge traversing the lumen of the bodily passage when situated therein and being configured such that the leaflet is cooperable with at least one other leaflet to define an opening that permits positive flow of fluid therethrough in a first direction, while the plurality of leaflets are further adapted to trap between the leaflets and the inner wall of the bodily passage fluid flowing in a second direction opposite the first direction and seal against one another to restrict fluid flow in said second direction; wherein the frame is adapted to assume a plurality of configurations, a first configuration of the plurality of configurations being a generally flat plane; and wherein the implantable valve includes at least one barb to anchor the implantable valve to the wall of the bodily passage; and wherein the number of leaflets of said implantable valve is equal to the number of bends occurring at each end of the frame.
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20. An implantable valve for a bodily passage of tubular shape, comprising:
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a frame that includes a plurality of legs, each of the legs originating from a pair of bends located about a first end of the implantable valve, and extending in an opposite direction therefrom, each of the plurality of legs terminating at a second end of the implantable valve opposite the first end such that the plurality of legs generally assume a serpentine configuration along the circumference of a bodily passage when situated therein, a plurality of leaflets, each leaflet comprising a covering that includes one or more flexible materials, the leaflet including a body that comprises a wall-engaging outer edge and an inner edge, the outer edge at least partially attached to, and reinforced by one of the plurality of legs, the outer edge and the associated leg adapted to sealingly engage the inner wall of the bodily passage, wherein the body of the leaflet extends inward from the wall of the bodily passage and extending toward the first end of the implantable valve where it terminates at the inner edge, the body and inner edge traversing the lumen of the bodily passage when situated therein and being configured such that the leaflet is cooperable with at least one other leaflet to define an opening that permits positive flow of fluid therethrough in a first direction, while the plurality of leaflets are further adapted to trap between the leaflets and the inner wall of the bodily passage fluid flowing in a second direction opposite the first direction and seal against one another to restrict fluid flow in said second direction; and wherein the frame is adapted to assume a plurality of configurations, a first configuration of the plurality of configurations being a generally flat plane; and wherein the covering includes two leaflets such that when the frame in the generally flat configuration generally assumes a diamond shape with the inner edges of the two leaflets defining a slit therebetween.
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21. A bi-leaflet valve prosthesis for implantation in a blood vessel, comprising:
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a support frame including a plurality of bends and interconnected sides, the support frame having a first configuration for intravascular delivery into the blood vessel and a second configuration for implantation therein;
the support frame having a first end and a second end, and the support frame having only two said bends occurring at each of said first end and second end;only two opposing leaflets, each leaflet having an inner edge and an outer edge; wherein the inner edges of the opposing leaflets are cooperable with one another to permit blood flow in a first direction within the vessel, while restricting blood flow in a second direction opposite the first direction; and wherein the outer edge of each of the leaflets is attached to at least one of the plurality of interconnected side elements such that the plurality of outer edges engage walls of the bodily passage and collectively form a seal thereagainst along a pathway defined by the plurality of interconnected side elements; wherein the outer edge of each of the leaflets includes an amount wrapped around a corresponding side element to which the outer edge is attached so as to provide an amount of material from which the leaflet is made occurring on an outer side of said side element; and wherein the prosthesis includes at least one barb to anchor the prosthesis to a wall of the bodily passage. - View Dependent Claims (22, 23)
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24. A bi-leaflet vascular valve prosthesis, comprising:
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a support frame including a first end and a second end and a plurality of bends and interconnected side elements, the support frame having a first configuration for intravascular delivery and a second configuration for implantation in a vascular vessel; only two bends occurring at each of said first end and said second end of said support frame, said bends including a first bend and a second bend at said first end of said support frame, wherein the first bend and the second bend are adapted to be positioned opposite one another when the support frame is in the second configuration; only two leaflets, said two leaflets including a first leaflet and a second leaflet providing a bi-leaflet valve configuration having a valve orifice extending in a direction between the first bend and the second bend; the first leaflet having a first outer edge portion attached extending along a side element connected to said first bend, and a second outer edge portion attached extending along a side element connected to the second bend; the second leaflet having a first outer edge portion attached extending along a side element connected to the first bend and a second outer edge portion attached extending along a side element connected to the second bend; wherein each of said outer edge portions is wrapped around a corresponding side element to which the outer edge portion is attached so as to provide an amount of material occurring on an outer side of said corresponding leg; and wherein said prosthesis includes at least one barb to anchor the prosthesis to a vascular vessel. - View Dependent Claims (25)
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Specification