Implantable repair device

Abstract

An implantable prosthesis for repairing or reinforcing a tissue or muscle wall defect including a first composite structure including at least one layer of a non-absorbable material, wherein the first composite structure has a central portion sized and shaped to cover at least a portion of the tissue or muscle wall defect, and has an outer periphery. The prosthesis further includes a second structure having a reinforced central region and an outer peripheral edge, a reinforcing element positioned between the first and second structures, and having an outer periphery and a stiffness greater than that of the first and second structures, and at least one pulling element coupled to the reinforced central region of the second structure. The second structure is coupled to the first structure substantially only at their respective peripheries.

1 . An implantable prosthesis for repairing or reinforcing a tissue or muscle wall defect, comprising:
 a first biocompatible structure having a central portion sized and shaped to cover at least a portion of the tissue or muscle wall defect and having a top side, a bottom side, and first and second extension portions extending laterally outward from opposite sides of the central portion;   a reinforcement element positioned adjacent the top side of the patch portion and having a top side, a bottom side, and an outer circumferential edge; and   a second biocompatible structure having a top side and a bottom side and at least one opening therethrough, the at least one opening being substantially centrally located;   wherein the first and second extension portions of the first structure extend about the outer circumferential edge of the reinforcement element and then inwardly along the top side of the reinforcement element between the reinforcement element and the second structure, to a central portion of the reinforcement element, and then outwardly from the central portion through the at least one opening in the second structure, the first and second structures being secured to one another at least about a peripheral edge of the prosthesis.   
     
     
         2 . The prosthesis according to  claim 1 , wherein the reinforcement element has a stiffness greater than a stiffness of the first and second structures. 
     
     
         3 . The prosthesis according to  claim 1 , wherein the reinforcement element further comprises an outer circumferential ring and an inner circumferential ring and a plurality of spoke elements extending there between. 
     
     
         4 . The prosthesis according to  claim 1 , wherein the reinforcement element has a three-dimensional shape. 
     
     
         5 . The prosthesis according to  claim 4 , wherein the reinforcement element further comprises an outer circumferential ring, an inner circumferential ring, and a plurality of spoke elements extending there between, and wherein the outer circumferential ring lies substantially in a first horizontal plane and the inner circumferential ring lies substantially in a second horizontal plane spaced apart from the first horizontal plane. 
     
     
         6 . The prosthesis according to  claim 5 , further comprising at least one rib-like element extending outwardly from at least one of the plurality of spoke elements, and aligned longitudinally along a length of the at least one spoke element. 
     
     
         7 . The prosthesis according to  claim 6 , wherein the at least one rib-like element is aligned longitudinally along a length of the at least one spoke element. 
     
     
         8 . The prosthesis according to  claim 1 , wherein distal ends of the first and second extension portions are folded over to form first and second looped elements. 
     
     
         9 . The prosthesis according to  claim 8 , further comprising first and second grasping members secured to the first and second looped elements respectively. 
     
     
         10 . The prosthesis according to  claim 1 , wherein the first structure further comprises:
 a patch member comprised of a non-absorbable mesh; and   first and second absorbable film layers positioned adjacent top and bottom sides of the patch member respectively and secured thereto.   
     
     
         11 . The prosthesis according to  claim 10 , wherein the patch member is comprised of polypropylene and the first and second film layers are comprised of polydioxanone. 
     
     
         12 . The prosthesis according to  claim 10 , wherein the first structure further comprises a third layer positioned adjacent to a bottom side of the second film layer and secured thereto. 
     
     
         13 . The prosthesis according to  claim 12 , wherein the third layer is comprised of an absorbable material. 
     
     
         14 . The prosthesis according to  claim 13 , wherein the third layer is comprised of oxidized regenerated cellulose. 
     
     
         15 . The prosthesis according to  claim 1 , wherein the second structure further comprises a ring element having an outer diameter less than an outer diameter of the second structure, and wherein the first and second extension portions of the first structure are coupled to the ring element. 
     
     
         16 . The prosthesis according to  claim 15 , wherein the second structure further comprises a mesh layer, and third and fourth film layers positioned adjacent top and bottom sides respectively of the mesh layer and secured thereto. 
     
     
         17 . The prosthesis according to  claim 16 , wherein the mesh layer and third and fourth film layers of the second structure are comprised of absorbable materials. 
     
     
         18 . The prosthesis according to  claim 17 , wherein the mesh layer is comprised of polyglactin and the third and fourth film layers are comprised of polydioxanone. 
     
     
         19 . An implantable prosthesis for repairing or reinforcing a tissue or muscle wall defect, comprising:
 a first composite structure including at least one layer of a non-absorbable material, the first composite structure having a central portion sized and shaped to cover at least a portion of the tissue or muscle wall defect, and having an outer periphery;   a second structure having a reinforced central region and an outer peripheral edge;   a reinforcing element positioned between the first and second structures, and having an outer periphery and a stiffness greater than that of the first and second structures; and   at least one pulling element coupled to the reinforced central region of the second structure;   wherein the second structure is coupled to the first structure substantially only at their respective peripheries.   
     
     
         20 . The prosthesis according to  claim 19  having a substantially circular overall shape. 
     
     
         21 . The prosthesis according to  claim 19 , wherein the reinforcing element has a three-dimensional shape. 
     
     
         22 . The prosthesis according to  claim 21 , wherein the reinforcing element has an outer circumferential ring lying in a first horizontal plane and an inner circumferential ring lying in a second horizontal plane spaced apart from the first horizontal plane, and a plurality of spoke element extending between the inner and outer circumferential rings. 
     
     
         23 . The prosthesis according to  claim 19 , wherein the first composite structure further comprises first and second absorbable film layers positioned adjacent top and bottom sides of the non-absorbable layer. 
     
     
         24 . The prosthesis according to  claim 23 , wherein the non-absorbable layer is a mesh layer. 
     
     
         25 . The prosthesis according to  claim 24 , wherein the first composite structure further includes an absorbable layer positioned adjacent a bottom side of the first film layer. 
     
     
         26 . The prosthesis according to  claim 19 , wherein the central region of the second structure is reinforced by a ring element located therein. 
     
     
         27 . The prosthesis according to  claim 19 , wherein the second composite structure is comprised of absorbable materials. 
     
     
         28 . An implantable prosthesis for repairing or reinforcing a tissue or muscle wall defect, comprising:
 a first substantially flat, flexible composite structure including at least one layer of non-absorbable material, the first composite structure having a central portion sized and shaped to cover at least a portion of the tissue or muscle wall defect and having an outer periphery;   a second substantially flat, flexible, structure having an outer periphery substantially similar to the outer periphery of the first structure, and having a reinforced central region;   a three-dimensional reinforcing element positioned between the first and second structures and having an outer periphery substantially similar to the outer periphery of the first and second structures; and   at least one pulling element coupled to the central region of the second structure;   wherein the first composite structure and the second structure are coupled to one another substantially only around their respective outer peripheries.   
     
     
         29 . The prosthesis according to  claim 28 , wherein the reinforcement element further comprises an outer circumferential ring in a first horizontal plane, an inner circumferential ring in a second horizontal plane, and a plurality of spoke elements extending therebetween. 
     
     
         30 . The prosthesis according to  claim 28 , wherein the at least one pulling element is a separate element coupled directly to the reinforced central region of the second structure. 
     
     
         31 . The prosthesis according to  claim 28 , wherein the at least one pulling element is integrally formed with the first composite structure. 
     
     
         32 . The prosthesis according to  claim 28 , wherein the non-absorbable layer of the first laminate structure is a mesh, and wherein the first structure further comprises first and second absorbable film layers positioned adjacent the top and bottom sides of the mesh. 
     
     
         33 . The prosthesis according to  claim 32 , wherein the mesh is comprised of polypropylene and the first and second film layers are comprised of polydioxanone. 
     
     
         34 . The prosthesis according to  claim 33 , wherein the second structure is further comprised of a mesh layer and third and fourth film layers positioned adjacent top and bottom sides of the mesh layer. 
     
     
         35 . The prosthesis according to  claim 34 , wherein the mesh layer and third and fourth film layers of the second structure are comprised of absorbable materials. 
     
     
         36 . The prosthesis according to  claim 28 , wherein the reinforcing element is comprised of an absorbable material. 
     
     
         37 . An implantable prosthesis for repairing or reinforcing a tissue or muscle wall defect, comprising:
 a first biocompatible structure having a central portion sized and shaped to cover at least a portion of the tissue or muscle wall defect and having a top side, a bottom side,   and first and second extension portions extending laterally outward from opposite sides of the central portion;   a reinforcement element positioned adjacent the top side of the first structure and having a top side, a bottom side, and an outer circumferential edge wherein the reinforcement element further comprises rings and a plurality of spoke elements extending therebetween; and,   a second biocompatible structure having a top side and a bottom side and at least one opening therethrough, the at least one opening being substantially centrally located;   wherein the first and second extension portions of the first structure extend about the outer circumferential edge of the reinforcement element and then inwardly along the top side of the reinforcement element between the reinforcement element and the second structure, to a central portion of the reinforcement element, and then outwardly from the central portion through the at least one opening in the second structure, the first and second structures being secured to one another at least about a peripheral edge of the prosthesis.   
     
     
         38 . The prosthesis according to  claim 37 , wherein the reinforcement element has a stiffness greater than a stiffness of the first and second structures. 
     
     
         39 . The prosthesis according to  claim 37 , wherein the reinforcement element has a three-dimensional shape. 
     
     
         40 . The prosthesis according to  claim 37 , wherein distal ends of the first and second extension portions are folded over to form first and second looped elements, and further comprising first and second grasping members secured to the first and second looped elements respectively. 
     
     
         41 . The prosthesis according to  claim 37 , wherein the first structure further comprises:
 a patch member comprised of a non-absorbable mesh; and   first and second absorbable film layers positioned adjacent top and bottom sides of the patch member respectively and secured thereto.   
     
     
         42 . The prosthesis according to  claim 41 , wherein the patch member is comprised of polypropylene and the first and second film layers are comprised of polydioxanone. 
     
     
         43 . The prosthesis according to  claim 41 , wherein the first structure further comprises a third layer of an absorbable material positioned adjacent to a bottom side of the second film layer and secured thereto. 
     
     
         44 . The prosthesis according to  claim 37 , wherein the second structure further comprises a ring element having an outer diameter less than an outer diameter of the second structure, and wherein the first and second extension portions of the first structure are coupled to the ring element. 
     
     
         45 . The prosthesis according to  claim 44 , wherein the second structure further comprises a mesh layer, and third and fourth film layers positioned adjacent top and bottom sides respectively of the mesh layer and secured thereto, and wherein the mesh layer and third and fourth film layers of the second structure are comprised of an absorbable material. 
     
     
         46 - 88 . (canceled)