Implantable vascular device comprising a bioabsorbable frame

Abstract

A multiple-sided valve for implantation within a body vessel comprising a frame comprising a bioabsorbable material is provided. The devices can be 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, or a bioabsorbable material, including a collagen-based material such as small intestinal submucosa (SIS), may be attached to the frame to form an occlusion device, a graft, or an implantable, intraluminal valve such as for correcting incompetent veins in the lower legs and feet.

1 . A device for implantation within a bodily passage comprising: 
 a bioabsorbable frame; and    at least one leaflet formed by a covering having remodelable properties that is attached to a portion of the frame;    wherein the leaflet has a flexible free edge that defines at least a portion of a valve orifice.    
   
   
       2 . The device for implantation within a body passage of  claim 1 , wherein the flexible free edge is an outer body edge of the leaflet.  
   
   
       3 . The device for implantation within a body passage of  claim 1 , wherein the leaflet has an arcuate shape.  
   
   
       4 . The device for implantation within a body passage of  claim 1 , wherein the flexible free edge at least partially opens in response to force exerted by a fluid traveling in a first direction within a bodily passage.  
   
   
       5 . The device for implantation within a body passage of  claim 1 , wherein the frame is formed integrally with the covering.  
   
   
       6 . The device for implantation within a body passage of  claim 1 , wherein the frame is moveable between a deployed configuration and a compressed delivery configuration.  
   
   
       7 . The device for implantation within a body passage of  claim 6 , wherein the frame in the deployed configuration assumes a serpentine configuration.  
   
   
       8 . The device for implantation within a body passage of  claim 1 , wherein the frame further comprises a means for anchoring the device in the lumen of a body passage.  
   
   
       9 . The device for implantation within a body passage of  claim 1 , wherein the frame further comprises one or more barbs.  
   
   
       10 . The device for implantation within a body passage of  claim 1 , wherein the material with remodeling properties is an extracellular matrix material.  
   
   
       11 . The device for implantation within a body passage of  claim 10 , wherein the extracellular matrix material is selected from the group consisting of: small intestine submucosa, pericardium, stomach submucosa, liver basement membrane, urinary bladder submucosa, tissue mucosa and dura mater.  
   
   
       12 . The device for implantation within a body passage of  claim 1 , wherein the material with remodeling properties is small intestine submucosa.  
   
   
       13 . The device for implantation within a body passage of  claim 1 , wherein the bioabsorbable material is selected from the group consisting of: poly-alpha hydroxyl acid, trimethylene carbonate, polycaprolactone, poly-beta hydroxyl acid, polyphosphazine, polyorganophosphazine, polyanhydride, polyesteramide, polyorthoester, polyethylene oxide, polyester-ether and polyamino acid.  
   
   
       14 . The device for implantation within a body passage of  claim 1 , wherein the bioabsorbable material is polyacetic acid, polylactide, polyglycolic acid or polyglycolide.  
   
   
       15 . The device for implantation within a body passage of  claim 1 , wherein the bioabsorbable material is polyhydroxybutyrate, polyhydroxyvalerate or a polydioxanone polyester-ether.  
   
   
       16 . The device for implantation within a body passage of  claim 1 , wherein the bioabsorbable material is poly-L-glutamic acid or poly-L-lysine.  
   
   
       17 . The device for implantation within a body passage of  claim 1 , wherein the bioabsorbable material is a modified polysaccharide, fibrin or casein.  
   
   
       18 . The device for implantation within a body passage of  claim 1 , wherein the bioabsorbable material is cellulose, chitin or dextran.  
   
   
       19 . A valve for implantation within a body passage, comprising: 
 a bioadsorbable frame, and two or more leaflets,    wherein each leaflet is formed by a covering having remodelable properties that is attached to one or more portions of the frame;    wherein each leaflet has a flexible free edge, and    wherein each flexible free edge of each leaflet meets to cooperably define an opening.    
   
   
       20 . Te valve of  claim 19 , wherein the valve has two leaflets.  
   
   
       21 . The valve of  claim 19 , wherein the valve has three leaflets.  
   
   
       22 . The valve of  claim 19 , wherein the covering with remodelable properties is an extracellular matrix material.  
   
   
       23 . The valve of  claim 19 , wherein the bioabsorbable frame comprises a material selected from the group consisting of: poly-alpha hydroxyl acid, trimethylene carbonate, polycaprolactone, poly-beta hydroxyl acid, polyphosphazine, polyorganophosphazine, polyanhydride, polyesteramide, polyorthoester, polyethylene oxide, polyester-ether and polyamino acid.  
   
   
       24 . A device for implantation within a body passage comprising: 
 a single frame having two or more sides, the frame formed into two or more legs and comprised of a bioabsorbable material;    a covering attached to at least two sides of a first leg to form a body of a first leaflet, the covering comprising a material with remodeling properties;    the first leaflet having an inner body edge and an outer body edge; and    wherein the inner body edge of the first leaflet is a flexible free edge that defines at least a portion of a valve orifice.    
   
   
       25 . The valve for implantation within a body passage of  claim 24  wherein the inner body edge of the first leaflet and the inner body edge of the second leaflet are sufficiently flexible to move apart in response to fluid flow through the valve orifice in a first direction.  
   
   
       26 . The valve for implantation within a body passage of  claim 25  wherein the inner body edge of the first leaflet is cooperable with the inner body edge of the second leaflet to substantially prevent retrograde fluid flow in a second direction that is opposite the first direction.  
   
   
       27 . The valve for implantation within a body passage of  claim 24  wherein the material with remodeling properties is an extracellular matrix material.  
   
   
       28 . The valve for implantation within a body passage of  claim 24  wherein the extracellular matrix material is selected from the group consisting of: 
 small intestine submucosa, pericardium, stomach submucosa, liver basement membrane, urinary bladder submucosa, tissue mucosa and dura mater.    
   
   
       29 . The valve for implantation within a body passage of  claim 24 , wherein the material with remodeling properties is small intestine submucosa.  
   
   
       30 . The valve for implantation within a body passage of  claim 24 , wherein the bioabsorbable material is selected from the group consisting of: poly-alpha hydroxyl acid, trimethylene carbonate, polycaprolactone, poly-beta hydroxyl acid, polyphosphazine, polyorganophosphazine, polyanhydride, polyesteramide, polyorthoester, polyethylene oxide, polyester-ether and polyamino acid.  
   
   
       31 . The valve for implantation within a body passage of  claim 24 , wherein the bioabsorbable material is polyacetic acid, polylactide, polyglycolic acid or polyglycolide.  
   
   
       32 . The valve for implantation within a body passage of  claim 24 , wherein the bioabsorbable material is a polydioxanone polyester-ether, polyhydroxybutyrate or polyhydroxyvalerate.  
   
   
       33 . The valve for implantation within a body passage of  claim 24 , wherein the bioabsorbable material is poly-L-glutamic acid or poly-L-lysine.  
   
   
       34 . The valve for implantation within a body passage of  claim 24 , wherein the bioabsorbable material is fibrin, casein or a modified polysaccharide.  
   
   
       35 . The valve for implantation within a body passage of  claim 24 , wherein the bioabsorbable material is cellulose, chitin or dextran.  
   
   
       36 . A valve for implantation within a body passage comprising: 
 a single frame having two or more sides, the frame formed into two or more legs and comprised of a bioabsorbable material;    a covering attached to at least two sides of a first leg to form the body of a first leaflet, the covering comprising a material with remodeling properties;    the first leaflet having a first inner body edge and a first outer body edge;    wherein the first inner body edge of the first leaflet is a first flexible free edge that defines at least a portion of a valve orifice;    the covering attached to at least two sides of a second leg to form the body of a second leaflet, the covering comprising a material with remodeling properties;    the second leaflet having a second inner body edge and a second outer body edge; and    wherein the second inner body edge of the second leaflet is a second flexible free edge that defines at least a portion of the valve orifice.    
   
   
       37 . A valve for implantation within a body passage comprising: 
 a single frame having two or more sides, the frame formed into three or more legs and comprising a bioabsorbable material;    a covering attached to at least two sides of a first leg to form the body of a first leaflet, the covering comprising a material with remodeling properties;    the first leaflet having a first inner body edge and a first outer body edge;    wherein the first inner body edge is a first flexible free edge that defines at least a portion of a valve orifice;    the covering attached to at least two sides of a second leg to form the body of a second leaflet, the covering comprising a material with remodeling properties;    the second leaflet having a second inner body edge and a second outer body edge; and    wherein the second inner body edge is a second flexible free edge that defines at least a portion of the valve orifice; and    the covering attached to at least two sides of a third leg to form the body of a third leaflet, the covering comprising a material with remodeling properties;    the third leaflet having a third inner body edge and a third outer body edge; and    wherein the third inner body edge is a third flexible free edge that defines at least a portion of the valve orifice.    
   
   
       38 . The device for implantation within a body passage of  claim 37  wherein the first inner body edge, the second inner body edge, and the third inner body edge, are sufficiently flexible to move apart in response to fluid flow through the valve orifice in a first direction.  
   
   
       39 . The device for implantation within a body passage of  claim 37 , wherein the first inner body edge is cooperable with the second inner body edge of the second leaflet and the third inner body edge to substantially prevent retrograde fluid flow in a second direction that is opposite the first direction.  
   
   
       40 . The device for implantation within a body passage of  claim 37  wherein the material with remodeling properties is an extracellular matrix material.  
   
   
       41 . The device for implantation within a body passage of  claim 37 , wherein the extracellular matrix material is selected from the group consisting of: small intestine submucosa, pericardium, stomach submucosa, liver basement membrane, urinary bladder submucosa, tissue mucosa and dura mater.  
   
   
       42 . A valve for implantation within a body passage comprising: 
 a single frame having two or more sides, the frame formed into two or more legs and comprising a bioabsorbable material;    wherein the bioabsorbable material is selected from the group consisting of: polyacetic acid, polylactide, polyglycolic acid, polyglycolide, trimethylene carbonate, polycaprolactone, polyhydroxybutyrate, polyhydroxyvalerate, polyphosphazine, polyorganophosphazine, polyanhydride, polyesteramide, polyorthoester, polyethylene oxide, polyester-ether, poly-L-glutamic acid, poly-L-lysine, cellulose, chitin, dextran, fibrin and casein;    a covering attached to at least two sides of a first leg to form a body of a first leaflet, the covering comprising a material with remodeling properties;    wherein the material with remodeling properties is an extracellular matrix material selected from the group consisting of: small intestine submucosa, pericardium, stomach submucosa, liver basement membrane, urinary bladder submucosa, tissue mucosa and dura mater;    the first leaflet having a first inner body edge and a first outer body edge;    wherein the first inner body edge of the first leaflet comprises a first flexible free edge that defines at least a portion of a valve orifice.    the covering is attached to at least two sides of a second leg to form a body of a second leaflet, the covering comprising a material with remodeling properties;    the second leaflet having a second inner body edge and a second outer body edge;    wherein the second inner body edge comprises a second flexible free edge that defines at least a portion of the valve orifice;    the first flexible free edge and the second flexible free edge are sufficiently flexible to move apart in response to fluid flow through the valve orifice in a first direction;    the first inner body edge is cooperable with second the inner body edge to substantially prevent retrograde fluid flow within a body vessel in a second direction that is opposite the first direction;    wherein the first outer body edge has an arcuate shape;    wherein the frame is moveable between a deployed configuration and a compressed delivery configuration; and    wherein the frame comprises one or more barbs.