Implantable vascular device
First Claim
1. An implantable valve for a bodily passage of tubular shape, comprising:
- a plurality of leaflets, each leaflet thereof having a body extending from a wall-engaging outer edge to an inner edge proximate a corresponding inner edge of at least one or another of the plurality of leaflets, the inner edges of said plurality of 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 at least substantially occlude fluid flow in a second direction opposing the first direction, the outer edge of each of the plurality of leaflets adapted to engage a wall of the bodily passage oriented at least partially longitudinally therealong and at least partially circumferentially therearound such that the leaflet extends along said bodily passage away from the inner edges in said second direction,
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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.
868 Citations
49 Claims
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1. An implantable valve for a bodily passage of tubular shape, comprising:
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a plurality of leaflets, each leaflet thereof having a body extending from a wall-engaging outer edge to an inner edge proximate a corresponding inner edge of at least one or another of the plurality of leaflets, the inner edges of said plurality of 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 at least substantially occlude fluid flow in a second direction opposing the first direction, the outer edge of each of the plurality of leaflets adapted to engage a wall of the bodily passage oriented at least partially longitudinally therealong and at least partially circumferentially therearound such that the leaflet extends along said bodily passage away from the inner edges in said second direction, - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 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 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 a opposite direction therefrom, each of the plurality of legs terminating at the second end of the implantable valve 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, while the plurality of leaflets are further adapted to seal against one another to at least substantially reduce retrograde flow. - View Dependent Claims (20, 21, 22, 23, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37)
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24. The implantable valve of 19 wherein the frame includes at least one open section therealong, the at least one open section including a portion of the covering, the covering constraining the frame, thereby providing a bridge across the at least one open section.
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38. An implantable vascular valve comprising:
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a covering including first and second oppositely facing curvilinear surfaces when positioned across a vascular opening and also including at least a first arcuate outer edge that exerts pressure against, and at least forms a partial seal with, a vascular wall when positioned thereagainst;
wherein the covering also includes an orifice extending through the oppositely facing curvilinear surfaces;
wherein the orifice is in a closed position blocking fluid flow therethrough when fluid is applied to the first oppositely curvilinear surface with the valve positioned across the vascular opening; and
wherein the orifice is in an open position permitting fluid flow therethrough when fluid is applied to the second oppositely curvilinear surface with the valve positioned across the vascular opening. - View Dependent Claims (41)
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39. An implantable vascular valve comprising:
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a covering including first and second oppositely curvilinear facing surfaces when positioned across a vascular opening and also including at least a first resilient arcuate outer edge that exerts pressure against, and at least forms a partial seal with, a vascular wall when positioned thereagainst;
wherein the covering also includes an orifice extending through the oppositely facing curvilinear surfaces;
wherein the orifice is in a closed position blocking fluid flow therethrough when fluid is applied to the first oppositely curvilinear surface with the valve positioned across the vascular opening; and
wherein the orifice is in an open position permitting fluid flow therethrough when fluid is applied to the second oppositely curvilinear surface with the valve positioned across the vascular opening.
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40. An implantable vascular valve comprising:
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a covering including first and second oppositely facing curvilinear surfaces when positioned across a vascular opening and also including at least a first arcuate outer edge that exerts pressure against, and at least forms a partial seal with, a vascular wall when positioned thereagainst;
wherein the covering also includes an orifice extending through the oppositely facing curvilinear surfaces and has at least a flexible portion cooperating with the orifice;
wherein the orifice is in a closed position blocking fluid flow therethrough when fluid is applied to the first oppositely curvilinear surface with the valve positioned across the vascular opening; and
wherein the orifice is in an open position permitting fluid flow therethrough when fluid is applied to the second oppositely curvilinear surface with the valve positioned across the vascular opening. - View Dependent Claims (43, 46, 47)
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42. An implantable vascular valve comprising:
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a covering including first and second oppositely facing curvilinear surfaces when positioned across a vascular opening and also including at least a first arcuate outer edge that exerts pressure against, and at least forms a partial seal with, a vascular wall when positioned thereagainst;
wherein the covering also includes an orifice extending through the oppositely facing curvilinear surfaces and has at least a first and a second flexible portion cooperating with the orifice;
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wherein the orifice is in a closed position blocking fluid flow therethrough when fluid is applied to the first oppositely curvilinear surface with the valve positioned across the vascular opening; and
wherein the orifice is in an open position permitting fluid flow therethrough when fluid is applied to the second oppositely curvilinear surface with the valve positioned across the vascular opening.
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44. An implantable medical device comprising:
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a covering including first and second oppositely facing curvilinear surfaces when positioned across a vascular opening and also including at least a resilient first arcuate outer edge that exerts pressure against, and at least forms a partial seal with, a vascular wall when positioned thereagainst;
wherein the covering is constrained in a predetermined direction, whereby at least the pressure exerted against the vascular wall is distributed substantially uniformly.
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45. A multiple-sided intraluminal medical device comprising:
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a single frame having a closed circumference with an aperture therethrough, said closed circumference having a plurality of sides, adjacent ones of said plurality of sides and interconnecting bends, the frame adapted to assume a plurality of configurations, a fist configuration of the plurality of configurations being in a generally flat plane;
wherein, the frame, having been formed in a first shape, is so constrained into a second shape such that at least selected ones of the plurality of bends, having been resiliently formed into a first angle between respective adjacent ones of the plurality of sides, are maintained at a second angle such that the frame is constrained against its bias to return to the first shape such that the at least selected ones of the plurality of bends would reassume the first angle between the adjacent ones of the plurality of sides.
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48. An implantable valve for a bodily passage of tubular shape, comprising:
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a frame having a pair of legs, the frame being radially expandable against the walls of the bodily passage, a plurality of leaflets comprising material derived from small intestinal submucosa, each leaflet thereof having a body extending from a wall-engaging outer edge to a free edge proximate a corresponding free edge of at least one or another of the plurality of leaflets, the wall-engaging outer edge of the leaflet being at least partially reinforced by one of the plurality of legs of the frame, the free edges of said plurality of leaflets cooperable to define an opening therebetween to permit fluid flow in a first direction along said bodily passage, and further cooperable to engage each other sufficiently to at least substantially occlude fluid flow in a second direction opposing the first direction, the outer edge of each said leaflet adapted to engage a wall of the bodily passage oriented at least partially longitudinally therealong and at least partially circumferentially therearound such that the leaflet extends along said bodily passage away from the free edges in said second direction, at least a portion of the body of each said leaflet being flexible at least proximate the free edge thereof, and the plurality of leaflets having a first shape when unconstrained and relaxed and being compressible into a second shape of smaller general size for delivery to a treatment site in said bodily passage, and being expandable at said treatment site upon delivery thereto for the outer edges of said leaflets to sealingly engage the passage wall while the free edges of the bodies of all said leaflets are moveable into and out of engagement with each other in response to fluid flow.
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49. An implantable valve for a bodily passage of tubular shape, comprising:
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a self-expanding frame that includes a pair of legs, each of the legs originating from a pair of bends located about a first end of the implantable valve, and extending in a opposite direction therefrom, each of the pair of legs terminating about the second end of the implantable valve such that the pair of legs generally and collectively assume a serpentine configuration along the circumference of a bodily passage when situated therein;
a plurality of barbs, at least one barb attached to each of the pair of legs, at least one of the barb including a terminal projection, the terminal projection configured to releasably engage with a delivery system for deployment of the inplantable valve into the bodily passage;
a pair of leaflets, each leaflet comprising tissue derived from an extracellular collagen matrix, each of the leaflets including a body that comprises a wall-engaging outer edge and an inner edge, the outer edge at least partially attached to, and reinforced the frame, 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 the other of the plurality of leaflets to define an opening that permits positive flow of fluid therethrough, while the pair of leaflets are further adapted to seal against one another to at least substantially reduce retrograde flow.
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Specification