Filling structure for a graft system and methods of use

Abstract

A system for treating an aneurysm includes a first double-walled filling structure having an outer wall and an inner wall. The filling structure is adapted to be filled with a hardenable fluid filling medium so that the outer wall conforms to an inside surface of the aneurysm and the inner wall forms a generally tubular lumen to permit blood flow therethrough. The inner wall comprises a blood contacting layer and a reinforcing layer. The reinforcing layer prevents circumferential creep or elastic expansion of the lumen.

1 . A system for treating an aneurysm, said system comprising:
 a first double-walled filling structure having an outer wall and an inner wall, wherein the filling structure is adapted to be filled with a hardenable fluid filling medium so that the outer wall conforms to an inside surface of the aneurysm and the inner wall forms a generally tubular lumen to permit blood flow therethrough, and   wherein the inner wall comprises a blood contacting layer and a reinforcing layer, the reinforcing layer adapted to prevent circumferential creep or elastic expansion of the lumen.   
     
     
         2 . The system of  claim 1 , wherein the reinforcing layer comprises a metal, textile, membrane, or polymer mesh. 
     
     
         3 . The system of  claim 1 , wherein the reinforcing layer comprises fibers or filaments circumferentially disposed around the lumen. 
     
     
         4 . The system of  claim 1 , wherein the reinforcing layer comprises fibers or filaments disposed spirally around the lumen. 
     
     
         5 . The system of  claim 3 , wherein the fibers or filaments comprise a metal, a polymer, a membrane, or a textile. 
     
     
         6 . The system of  claim 1 , wherein the reinforcing layer encircles the inner lumen and is substantially noncompliant. 
     
     
         7 . The system of  claim 6 , wherein the inner lumen has a longitudinal length, and wherein the reinforcing layer has a longitudinal length that is less than the longitudinal length of the inner lumen. 
     
     
         8 . The system of  claim 7 , wherein the inner lumen has proximal and distal ends, and wherein the proximal and distal ends are flared. 
     
     
         9 . A system for treating an aneurysm, said system comprising:
 a first double-walled filling structure having an outer wall and an inner wall, wherein the filling structure is adapted to be filled with a hardenable fluid filling medium so that the outer wall conforms to an inside surface of the aneurysm and the inner wall forms a generally tubular lumen to permit blood flow therethrough, and   wherein the inner wall is comprised of a material with anisotropic stress properties oriented such that its greatest tensile strength is circumferential.   
     
     
         10 . A system for treating an aneurysm, said system comprising:
 a first double-walled filling structure having an outer wall and an inner wall, wherein the filling structure is adapted to be filled with a hardenable fluid filling medium so that the outer wall conforms to an inside surface of the aneurysm and the inner wall forms a generally tubular lumen to permit blood flow, and   wherein the lumen has a first end and a second end opposite the first end, and wherein a diameter at the first end or the second end is greater than a diameter of the lumen at a point between the first and the second ends.   
     
     
         11 . A system for treating an aneurysm, said system comprising:
 a first multi-walled filling structure having at least an outer wall and an inner wall, wherein the filling structure is adapted to be filled with a hardenable fluid filling medium so that the outer wall conforms to an inside surface of the aneurysm and the inner wall forms a generally tubular lumen to permit blood flow therethrough, and   wherein the filling structure comprises at least one interior wall that divides the multi-walled filling structure into at least a first compartment and a second compartment, each of the compartments fillable with the hardenable fluid filling medium or another filling medium.   
     
     
         12 . The system of  claim 11 , further comprising a fill port in fluid communication with the first compartment. 
     
     
         13 . The system of  claim 11 , wherein the first compartment surrounds the tubular lumen, and the second compartment surrounds the first compartment. 
     
     
         14 . The system of  claim 11 , wherein the first compartment is in restricted fluid communication with the second compartment. 
     
     
         15 . The system of  claim 11 , further comprising a first fill port in fluid communication with the first compartment, and a second fill port in fluid communication with the second compartment. 
     
     
         16 . The system of  claim 1 , wherein the inner surface of the filling structure is coated and modified to adhere with the filling medium. 
     
     
         17 . The system of  claim 1 , where the filling medium adheres to the inner walls of the filling structure to maintain device shape over time. 
     
     
         18 . The system of  claim 11 , where the inner and outer compartments are filled with filling media of varying mechanical properties to withstand mechanical forces from blood flow and long-term aneurysm remodeling. 
     
     
         19 . A system for treating an aneurysm, said system comprising:
 a first double-walled filling structure having a differential functional construct including an toroidal outer surface with a tubular inner lumen, wherein the filling structure is adapted to be filled with a hardenable fluid filling medium so that the outer surface wall conforms to an inside surface of the aneurysm and the lumenal wall forms a generally tubular lumen to permit blood flow therethrough, and wherein the lumenal wall withstands mechanical forces from blood flow and long-term aneurismal remodeling.   
     
     
         20 . A system for treating an aneurysm, said system comprising:
 a first double-walled filling structure having an outer wall and an inner wall, wherein the filling structure is adapted to be filled with a hardenable fluid filling medium so that the outer wall conforms to an inside surface of the aneurysm and the inner wall forms a generally tubular lumen to permit blood flow therethrough, and   wherein the inner wall is comprised of a first material and the outer wall is comprised of a second material that is different from the first material, and   wherein the inner wall material is adapted to resist creep and expansion due to pulsatile blood flow, and the outer wall is adapted to conform with the aneurismal sac.   
     
     
         21 . A system for treating an aneurysm, said system comprising:
 a first double-walled filling structure having an outer wall and an inner wall, wherein the filling structure is adapted to be filled with a hardenable fluid filling medium so that the outer wall conforms to an inside surface of the aneurysm and the inner wall forms a generally tubular lumen to permit blood flow therethrough, and   wherein the inner wall is has a first thickness and the outer wall has a second thickness that is less than the first thickness.   
     
     
         22 . A method for treating an aneurysm, said method comprising:
 providing a double-walled filling structure having an outer wall and an inner wall;   positioning the double-walled filling structure adjacent the aneurysm;   filling the filling structure with a hardenable fluid filling medium so that the outer wall conforms to an inside surface of the aneurysm and the inner wall forms a generally tubular lumen to permit blood flow therethrough; and   constraining the lumen from creeping or elastically expanding due to the blood flow through the lumen.   
     
     
         23 . The method of  claim 22 , wherein the constraining step comprises providing a reinforcing layer disposed at least partially around the tubular lumen. 
     
     
         24 . The method of  claim 22 , wherein the constraining step comprises filling a compartment disposed at least partially around the tubular lumen with the hardenable fluid filling medium.