Reinforced Biological Tissue
The present invention provides for an implantable medical device comprising a hybrid composite material including a first biological component such as an acellular tissue matrix and a second non-biological component for strengthening the device after implantation.
1 . A method of treatment, comprising:
identifying an implant site of a patient with a ligament, tendon, or soft tissue structure defect;
providing a composite material to the implant site to regenerate the ligament, tendon, or soft tissue structure defect, the composite material including (i) a sheet of an acellular tissue matrix, and (ii) a non-biological component including an upper portion and a lower portion, and a neck portion between the upper portion and the lower portion, the sheet of the acellular tissue matrix wrapping around the neck portion of the non-biological component between the upper portion and the lower portion and covering at least a portion of a surface of the non-biological component to form an elongated composite having a predetermined target load capacity approximating the load capacity of a native human ligament, tendon, or soft tissue structure to be replaced by the elongated composite;
providing one or more anchors to secure the composite material to the implant site; and
anchoring the composite material to the implant site with the one or more anchors.
2 . The method of claim 1 , wherein the upper portion of the non-biological component is folded over in the direction of the lower portion of the non-biological component to overlap a portion of the wrapped sheet of the acellular tissue matrix with the non-biological component while maintaining a central portion of the wrapped sheet of the acellular tissue matrix exposed between the upper and lower portions of the non-biological component.
3 . The method of claim 1 , wherein the lower portion of the non-biological component is folded over in the direction of the upper portion of the non-biological component to overlap a portion of the wrapped sheet of the acellular tissue matrix with the non-biological component while maintaining a central portion of the wrapped sheet of the acellular tissue matrix exposed between the upper and lower portions of the non-biological component.
4 . The method of claim 1 , wherein the non-biological component has a higher tensile load capacity than the sheet of the acellular tissue matrix at the time of implantation.
5 . The method of claim 4 , wherein the sheet of the acellular tissue matrix has a higher load capacity than the non-biological component after implantation and following growth of native cells within the acellular tissue matrix.
6 . The method of claim 5 , wherein a load capacity of the composite material is within a target load capacity range at the time of implantation and also following growth of the native cells within the acellular tissue matrix.
7 . The method of claim 1 , comprising allowing growth of native cells within the acellular tissue matrix after implantation of the composite material.
8 . The method of claim 1 , maintaining a load capacity of the composite material within a target load capacity range at the time of implantation and following growth of native cells within the acellular tissue matrix.
9 . The method of claim 1 , wherein the one or more anchors include one or more interference screws.
10 . The method of claim 9 , comprising inserting the one or more interference screws into a core of the composite material.
11 . The method of claim 10 , comprising anchoring the composite material to the implant site with the one or more interference screws from inside of the composite material.
12 . The method of claim 1 , wherein the at least one sheet of acellular tissue matrix overlays the non-biological component.
13 . The method of claim 1 , wherein the non-biological component comprises a bioabsorbable polymer.
14 . The method of claim 1 , wherein the non-biological component comprises a biocompatible metal.
15 . The method of claim 1 , wherein the non-biological component comprises polyhydroxybutyrate, polyactic acid, polyactideglycolide acid, polydioxanone or polycaprolactone.
16 . The method of claim 1 , wherein the non-biological component is a textile in the form of a knit, a weave, a braid, a nonwoven structure, or a combination of knit, weave, braid or nonwoven structures.
17 . The method of claim 16 , wherein the non-biological component comprises a monofilament of non-biological material.
18 . The method of claim 16 , wherein the non-biological component comprises a braided or spun multifilament yarn.
19 . The method of claim 16 , wherein the sheet of the acellular tissue matrix is integrated into the textile structure of the non-biological component.
20 . The method of claim 1 , wherein the composite material forms a sheet, a cylinder, a solid tube, a hollow tube, or a rolled sheet.