Reinforced biologic material

Abstract

The present disclosure provides an implantable medical device comprising a composite graft material including a first biologic component, such as an acellular tissue matrix, and a second non-biologic component.

What is claimed is: 
     
         1 . A method of making a composite prosthesis, comprising:
 providing a plurality of first elongate non-biologic elements;   applying a load to the plurality of first elongate non-biologic elements;   covering at least a portion of the plurality of first elongate non-biologic elements with at least one biologic component; and   securing the plurality of first elongate non-biologic elements with at least one second elongate non-biologic element.   
     
     
         2 . The method of  claim 1 , wherein the plurality of first elongate non-biologic elements comprise at least one material chosen from bioabsorbable polymer, bioabsorbable metal, or a combination of bioabsorbable polymer and bioabsorbable metal. 
     
     
         3 . The method of  claim 1 , wherein the plurality of first elongate non-biologic elements comprise at least one material chosen from polyhydroxyalkanoate, polyhydroxybutyrate, polylactic acid (PLA), polyglycolic acid (PGA), polylactideglycolide acid (PLGA), polydioxanone (PDO), polycaprolactone (PCL), a polyanhydride, a polyorthoester, a poly(amino acid), a polypeptide, a polydepsipeptide, a nylon-2/nylon-6 copolyamide, a poly(alkylene succinate), poly(hydroxyl butyrate) (PHB), poly (butylene diglocolate), poly (ϵ-caprolactone), a polydihydropyran, a polyphosphazene, a poly (cyano acrylates), modified polysaccharides, cellulose, starch, chitin, modified proteins, collagen, fibrin, and copolymers thereof. 
     
     
         4 . The method of  claim 1 , wherein the plurality of first elongate non-biologic elements comprise at least one of a noble metal, near noble metal, iron, or magnesium. 
     
     
         5 . The method of  claim 1 , wherein the plurality of first elongate non-biologic elements comprises a plurality of threads, cords, cables, ribbons, or braids. 
     
     
         6 . The method of  claim 1 , further comprising:
 covering the plurality of first elongate non-biologic elements with a bioabsorbable sheath; and   applying a tensile load to the sheath and the plurality of first elongate non-biologic elements.   
     
     
         7 . The method of  claim 1 , wherein all or a portion of the plurality of first elongate non-biologic elements are tensile loaded with a force ranging from greater than 0 N to about 1800 N. 
     
     
         8 . The method of  claim 7 , wherein only a portion of the plurality of first elongate non-biologic elements are tensile loaded. 
     
     
         9 . The method of  claim 1 , wherein all or a portion of the plurality of first elongate non-biologic elements are compressively loaded. 
     
     
         10 . The method of  claim 9 , wherein only a portion of the first elongate non-biologic elements are compressively loaded. 
     
     
         11 . The method of  claim 1 , wherein the at least one biologic components comprises a biomatrix. 
     
     
         12 . The method of  claim 11 , wherein the biomatrix comprises an acellular tissue matrix or a particulate acellular tissue matrix. 
     
     
         13 . The method of  claim 1 , wherein the at least one biologic component forms a sheath about the plurality of first elongate non-biologic elements. 
     
     
         14 . The method of  claim 1 , wherein the at least one biologic component at least partially separates at least one of the elongate non-biologic elements comprised within the plurality of first elongate non-biologic elements. 
     
     
         15 . The method of  claim 1 , wherein the at least one biologic component at least partially coats each elongate member comprised within the plurality of elongate non-biologic elements. 
     
     
         16 . The method of  claim 1 , further comprising applying the at least one biologic component to the plurality of first elongate non-biologic elements in the form of a coating, a paste, a powder, a liquid, or a spray. 
     
     
         17 . The method of  claim 1 , wherein securing the plurality of first elongate non-biologic elements comprises at least one of whipping, wrapping, and winding an end portion of the plurality of first elongate non-biologic elements with the at least one second elongate non-biologic element. 
     
     
         18 . The method of  claim 17 , wherein securing the plurality of first elongate non-biologic elements includes formation of at least one layer of the at least one second elongate non-biologic element about the plurality of first elongate non-biologic elements. 
     
     
         19 . The method of  claim 18 , wherein securing the plurality of first elongate non-biologic elements includes formation of a pitched portion for engaging an anchoring screw. 
     
     
         20 . The method of  claim 1 , wherein the at least one second elongate non-biologic element is bioabsorbable. 
     
     
         21 . The method of  claim 1 , wherein the at least one second elongate non-biologic element is comprised of the same material as the plurality of first elongate non-biologic elements. 
     
     
         22 . The method of  claim 1 , wherein the at least one second elongate non-biologic element comprises a thread, cord, cable, ribbon, or braid. 
     
     
         23 . The method of  claim 1 , wherein the second elongate non-biologic element secures the plurality of first elongate non-biologic elements while maintaining the load applied to the plurality of first elongate non-biologic elements. 
     
     
         24 . The method of  claim 1 , wherein the plurality of first elongate non-biologic elements have a higher load capacity than the at least one biologic component at a time of implantation. 
     
     
         25 . The method of  claim 1 , wherein the at least one biologic component has a higher load capacity than the plurality of first elongate non-biologic elements after implantation and following ingrowth of native cells within the at least one biologic component. 
     
     
         26 . An method of making a composite prosthesis, comprising:
 providing at least one non-biologic core;   applying a tensile load to the non-biologic core; and   disposing at least one biologic element about the at least one non-biologic core, the at least one biologic element comprising a biomatrix,   wherein:
 the at least one non-biologic core bears a greater tensile load at a time of implantation than the at least one biologic element, while transmitting strain to the at least one biologic element; and 
 after implantation, the at least one non-biologic core gradually weakens, thereby transferring additional tensile load to the at least one biologic element. 
   
     
     
         27 . The method of  claim 26 , wherein the strain applied to the at least one biologic element by the at least one non-biologic core is less than 50% of the strain applied to the at least one non-biologic care by the at least one tensile load.