Multilayered implant materials derived from amniotic membrane, methods of making the multilayered implant materials, and method of using multilayered implant materials
View Patent ↗Exemplary embodiments of the present disclosure provide for multi-layered implantation materials, methods of making a multi-layered implantation material, methods of forming a multi-layered implantation material, methods of forming a multi-layered implantation material having a spiral roll cross-section, and the like.
1. A method of forming a multi-layered implantation material, comprising the steps of:
obtaining an amniotic membrane;
decellularizing the amniotic membrane to produce a decellularized amniotic membrane;
forming a multi-layered implantation material by wrapping the amniotic membrane around itself to form a multi-layered structure having a spiral roll cross-section with two or more spiral layers;
freeze drying the multi-layered implantation material; and
after forming the multi-layered implantation material, culturing the multi-layered implantation material under conditions whereby the membrane is colonized by a population of cells.
2. The method of claim 1 , wherein the decellularized amniotic membrane is substantially free of non-amniotic tissue.
3. The method of claim 1 , wherein the amniotic membrane is decellularized by contact with sodium dodecyl sulphate or sodium chloride.
4. The method of claim 1 , wherein the amniotic membrane is decellularized by contact with sodium chloride.
5. The method of claim 1 , wherein the multi-layered implantation material is an implant for a subject human or animal.
6. The method of claim 1 , further comprising: disposing the multi-layered implantation material onto a second multi-layered implantation material to form a structure; and freeze drying the structure.
7. The method of claim 6 , further comprising: drilling a plurality of drilled holes in the amniotic membrane.
8. The method of claim 6 , wherein the drilled holes can have a diameter of about 1 to 500 micrometers and wherein one or more pairs of drilled holes are spaced by about 1 micrometer to 10 millimeters.
9. The method of claim 1 , further comprising: drilling a plurality of holes in the multi-layered amniotic membrane before wrapping the amniotic membrane around itself.
10. The method of claim 9 , wherein the drilled holes can have a diameter of about 1 to 500 micrometers and wherein one or more pairs of drilled holes are spaced by about 1 micrometer to 10 millimeters.
11. The method of claim 9 , further comprising: freeze drying the amniotic membrane before drilling the plurality of holes.
12. The method of claim 11 , further comprising: cross-linking the multi-layered amniotic membrane.
13. The method of claim 1 , wherein wrapping includes wrapping the multi-layered implantation material around a structure to form the multi-layered implantation structure having the spiral roll cross-section, wherein removal of the structure provides a lumen oriented along the longitudinal axis of the multi-layered implantation structure.
14. The method of claim 13 , wherein the lumen has a substantially circular cross-section.
15. The method of claim 13 , wherein the lumen has a diameter of about 0.2 mm to 30 mm and wherein the multi-layered implant has a diameter of about 1 mm to 30 mm.
16. The method of claim 1 , wherein the population of cells is selected from the group consisting of: a stem cell, an endothelial cell, a smooth muscle cell, a fibroblast, and a combination thereof.
17. The method of claim 1 , wherein the population of cells is a homogeneous population of cells.
18. The method of claim 1 , wherein the population of cells is a heterogeneous population of cells.
19. A method of forming a multi-layered implantation material having a spiral roll cross-section, comprising the steps of:
wrapping an amniotic membrane around itself to form a multi-layered structure having the spiral roll cross-section, wherein the multi-layered implant has two or more spiral layers; and
freeze drying the multi-layered structure.
20. The method of claim 19 , wherein the multi-layered implantation material has an inner edge, an outer edge, and a longitudinal axis along the length of the multi-layered implant.
21. The method of claim 19 , wherein the multi-layered structure has a plurality of holes.
22. The method of claim 19 , further comprising: cross-linking the multi-layered structure.
23. The method of claim 19 , further comprising: drilling a plurality of holes in the multi-layered structure.
24. The method of claim 19 , further comprising disposing a population of cells on said amniotic membrane before wrapping.
25. The method of claim 24 , further comprising decellularizing the amniotic membrane before disposing the population of cells on the amniotic membrane.
26. The method of claim 24 , wherein the lumen has a diameter of about 0.2 mm to 30 mm and wherein the multi-layered implant has a outside diameter of about 1 mm to 30 mm.
27. The method of claim 19 , further comprising decellularizing the amniotic membrane before wrapping.
28. The method of claim 19 , wherein each spiral layer has a thickness of about 45 μm to 2000 μm.
29. The method of claim 19 , wherein the multi-layered implantation material has a width along the longitudinal axis of about 0.01 mm to 1200 mm.
30. A method of forming a non-synthetic, multi-layered implantation tubular scaffold, the method comprising:
wrapping an amniotic membrane around itself to form a multi-layered implantation tubular scaffold having a spiral roll cross-section with two or more spiral layers;
optionally freeze drying the multi-layered implantation tubular scaffold; and
optionally culturing the multi-layered implantation tubular scaffold under conditions whereby the membrane is colonized by a populations of cells;
wherein the multi-layered implantation tubular scaffold does not comprise synthetic materials.