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 . An implantable medical device, comprising:
a group of first elongate non-biologic elements;
a sheath wrapped around and surrounding at least a portion of the group of first elongate non-biologic elements; and
at least one second elongate non-biologic element, wherein the at least one second element secures at least one end portion of the group of first elongate non-biologic elements.
2 . The implantable medical device of claim 1 , wherein at least a portion of the group of first elongate non-biologic elements are under a tensile or compressive stress prior to implantation.
3 . The implantable medical device of claim 2 , wherein at least a portion of the group of first elongate non-biologic elements are loaded with the tensile or compressive stress independently of the sheath.
4 . The implantable medical device of claim 1 , wherein at least a portion of the group of first elongate non-biologic elements and the sheath are loaded together with a tensile or compressive stress.
5 . The implantable medical device of claim 2 , wherein the group of first elongate non-biologic elements have a higher load capacity than the sheath at the time of implantation.
6 . The implantable medical device of claim 5 , wherein the sheath has a higher load capacity than the group of first elongate non-biologic elements after implantation and following growth of native cells within the sheath.
7 . The implantable medical device of claim 1 , wherein the sheath comprises a non-biologic material.
8 . The implantable medical device of claim 1 , wherein the sheath comprises a biologic component including a biomatrix.
9 . The implantable medical device of claim 8 , wherein the biomatrix comprises an acellular tissue matrix or a particulate acellular tissue matrix.
10 . The implantable medical device of claim 1 , wherein the at least one second elongated non-biologic element is wrapped around and over the sheath to secure at least one end portion of the group of first elongate non-biologic elements.
11 . The implantable medical device of claim 1 , wherein the sheath forms a single layer over the group of first elongate non-biologic elements.
12 . The implantable medical device of claim 1 , wherein the sheath is wrapped in a jellyroll fashion with multiple layers over the group of first elongate non-biologic elements.
13 . The implantable medical device of claim 1 , wherein the sheath is wrapped in a non-uniform jellyroll fashion with multiple non-concentric layers over the group of first elongate non-biologic elements.
14 . The implantable medical device of claim 1 , comprising an outer sheath wrapped around and surrounding at least a portion of the sheath.
15 . The implantable medical device of claim 1 , wherein the group 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.
16 . The implantable medical device of claim 1 , wherein the group of first elongate non-biologic elements comprise at least one material chosen from polyhydroxyalkanoate, poly-hydroxybutyrate, 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(.epsilon.-caprolactone), a polydihydropyran, a polyphosphazene, a poly(cyano acrylates), modified polysaccharides, cellulose, starch, chitin, modified proteins, collagen, fibrin, and combinations and copolymers thereof.
17 . The implantable medical device of claim 1 , wherein the group of first elongate non-biologic elements comprise a bioabsorbable polymer, a bioabsorbable metal or a combination of a bioabsorbable polymer and bioabsorbable metal.
18 . The implantable medical device of claim 2 , wherein the group of first elongate non-biologic elements are under a tensile stress ranging from greater than 0 N to about 1800 N.
19 . The implantable medical device of claim 1 , wherein the group of first elongate non-biologic elements comprise a plurality of threads, cords, cables, ribbons, or braids.
20 . An implantable medical device, comprising:
a group of first elongate non-biologic elements, at least a portion of which are under a tensile or compressive stress prior to implantation;
a sheath wrapped around and surrounding at least a portion of the group of first elongate non-biologic elements; and
at least one second elongate non-biologic element, wherein the at least one second element secures at least one end portion of the group of first elongate non-biologic elements;
wherein the group of first elongate non-biologic elements have a higher load capacity than the sheath at the time of implantation; and
wherein the sheath has a higher load capacity than the group of first elongate non-biologic elements after implantation and following growth of native cells within the sheath.