REINFORCED BIOLOGIC MATERIAL
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.
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.