Tissue substitute materials and methods for tissue repair
Non-woven graft materials for use in specialized surgical procedures such as neurosurgical procedures, methods for making the non-woven graft materials, and methods for repairing tissue such as neurological tissue using the non-woven graft materials are disclosed. More particularly, disclosed are non-woven graft materials including at least two distinct fiber compositions composed of different polymeric materials, methods for making the non-woven graft materials and methods for repairing tissue in an individual in need thereof using the non-woven graft materials.
1. A bioabsorbable non-woven graft material for facilitating regeneration of tissue, the bioabsorbable non-woven graft material comprising:
a single layer non-woven electrospun polymeric scaffold configured to facilitate tissue growth within the single layer non-woven electrospun polymeric scaffold wherein the single layer non-woven electrospun polymeric scaffold is configured to be bioabsorbed whereby the facilitated tissue growth remains after the single layer non-woven electrospun polymeric scaffold is bioabsorbed, the single layer non-woven electrospun polymeric scaffold comprising:
a first electrospun non-woven fiber composition, wherein the first electrospun non-woven fiber composition comprises a first polymer comprising glycolic acid; and
a second electrospun non-woven fiber composition, wherein the second electrospun non-woven fiber composition comprises a second polymer comprising caprolactone,
wherein the first electrospun non-woven fiber composition and the second electrospun non-woven fiber composition comprise different polymers,
wherein the first electrospun non-woven fiber composition and the second electrospun non-woven fiber composition are electrospun to form throughout the single layer non-woven electrospun polymeric scaffold of the bioabsorbable non-woven graft material to create an architecture resembling a native extracellular matrix,
wherein the bioabsorbable non-woven graft material further comprises a first region and a second region,
wherein the bioabsorbable non-woven graft material further comprises a plurality of pores formed among the first electrospun non-woven fiber composition and the second electrospun non-woven fiber composition,
wherein a density of the first region is less than a density of the second region,
wherein the single non-woven electrospun polymeric scaffold is sufficiently flexible for applying the bioabsorbable non-woven graft material to tissue, the non-woven electrospun polymeric scaffold has sufficient mechanical strength for the bioabsorbable non-woven graft material to be suturable, and the non-woven electrospun polymeric scaffold has sufficient mechanical strength for the bioabsorbable non-woven graft material to be trimmable,
wherein the bioabsorbable non-woven graft material is configured to be used in conjunction with one or more sutures for attaching the bioabsorbable non-woven graft material to the tissue,
wherein the bioabsorbable non-woven graft material is configured to facilitate regeneration of the tissue,
wherein the bioabsorbable non-woven graft material does not comprise more than one non-woven electrospun polymeric scaffold.
2. The bioabsorbable non-woven graft material of claim 1 , wherein the tissue comprises tendon, and the bioabsorbable non-woven graft material is configured to repair or augment at least the tendon.
3. The bioabsorbable non-woven graft material of claim 1 , wherein the bioabsorbable non-woven graft material comprises one or more hollow hole depression areas.
4. The bioabsorbable non-woven graft material of claim 3 , wherein the bioabsorbable non-woven graft material is configured to receive the one or more sutures in the bioabsorbable non-woven graft material through the one or more depression areas.
5. The bioabsorbable non-woven graft material of claim 1 , wherein the bioabsorbable non-woven graft material comprises a structure of fibers that are interlaid in an arrangement to create the architecture resembling the native extracellular matrix.
6. The bioabsorbable non-woven graft material of claim 1 , wherein the bioabsorbable non-woven graft material comprises a suture pull-out strength, the suture pull-out strength ranging from 1 Newtons to about 5 Newtons of force required for the one or more sutures to be torn from bioabsorbable non-woven graft material.
7. The bioabsorbable non-woven graft material of claim 1 , wherein the bioabsorbable non-woven graft material comprises one or more pores to promote cell infiltration.
8. The bioabsorbable non-woven graft material of claim 1 , wherein the bioabsorbable non-woven graft material comprises interconnecting pores.
9. The bioabsorbable non-woven graft material of claim 1 , the bioabsorbable non-woven graft material comprising a surface pattern.
10. The bioabsorbable non-woven graft material of claim 9 , wherein the surface pattern comprises a repeating non-random pattern.
11. The bioabsorbable non-woven graft material of claim 1 , wherein the first electrospun non-woven fiber composition and the second electrospun non-woven fiber composition are uniformly distributed throughout the bioabsorbable non-woven graft material.
12. The bioabsorbable non-woven graft material of claim 1 , wherein the first electrospun non-woven fiber composition and the second electrospun non-woven fiber composition comprises an average diameter not greater than 5,000 nanometers.
13. A bioabsorbable non-woven graft material for facilitating regeneration of tissue, the bioabsorbable non-woven graft material comprising:
a single layer non-woven electrospun polymeric scaffold configured to facilitate tissue growth within the single layer non-woven electrospun polymeric scaffold wherein the single layer non-woven electrospun polymeric scaffold is configured to be bioabsorbed whereby the facilitated tissue growth remains after the single layer non-woven electrospun polymeric scaffold is bioabsorbed, the single layer non-woven electrospun polymeric scaffold comprising:
a first electrospun non-woven fiber composition, wherein the first electrospun non-woven fiber composition comprises a first polymer comprising polydioxanone; and
a second electrospun non-woven fiber composition, wherein the second electrospun non-woven fiber composition comprises a second polymer,
wherein the first electrospun non-woven fiber composition and the second electrospun non-woven fiber composition comprise different polymers,
wherein the first electrospun non-woven fiber composition and the second electrospun non-woven fiber composition are electrospun to form the single layer non-woven electrospun polymeric scaffold of the bioabsorbable non-woven graft material to create an architecture resembling a native extracellular matrix,
wherein the bioabsorbable non-woven graft material further comprises a first region and a second region,
wherein the bioabsorbable non-woven graft material further comprises a plurality of pores formed among the first electrospun non-woven fiber composition and the second electrospun non-woven fiber composition,
wherein a density of the first region is less than a density of the second region,
wherein the single non-woven electrospun polymeric scaffold is sufficiently flexible for applying the bioabsorbable non-woven graft material to tissue and the non-woven electrospun polymeric scaffold has sufficient mechanical strength for the bioabsorbable non-woven graft material to be trimmable,
wherein the bioabsorbable non-woven graft material is configured to be attached to the tissue, and wherein the bioabsorbable non-woven graft material is configured to facilitate regeneration of the tissue,
wherein the bioabsorbable non-woven graft material does not comprise more than one non-woven electrospun polymeric scaffold.
14. The bioabsorbable non-woven graft material of claim 13 , wherein the second polymer comprises poly(lactic-co-glycolic acid).
15. The bioabsorbable non-woven graft material of claim 14 , wherein the tissue comprises one or more of dura mater, pericardium, small intestinal submucosa, dermis, epidermis, tendon, trachea, heart valve leaflet, gastrointestinal tract, and cardiac tissue.
16. The bioabsorbable non-woven graft material of claim 14 , wherein the bioabsorbable non-woven graft material is configured to be attached to the tissue using one or more sutures.
17. The bioabsorbable non-woven graft material of claim 16 , wherein the bioabsorbable non-woven graft material comprises one or more hollow hole depression areas.
18. The bioabsorbable non-woven graft material of claim 17 , wherein the bioabsorbable non-woven graft material is configured to receive the one or more sutures in the bioabsorbable non-woven graft material through the depression area.
19. The bioabsorbable non-woven graft material of claim 16 , wherein the bioabsorbable non-woven graft material comprises a suture pull-out strength, the suture pull-out strength ranging from 1 Newtons to about 5 Newtons of force required for the one or more sutures to be torn from bioabsorbable non-woven graft material.
20. The bioabsorbable non-woven graft material of claim 14 , wherein the bioabsorbable non-woven graft material comprises a structure of fibers that are interlaid in an arrangement to create the architecture resembling the native extracellular matrix.
21. The bioabsorbable non-woven graft material of claim 14 , wherein the bioabsorbable non-woven graft material comprises one or more pores to promote cell infiltration.
22. The bioabsorbable non-woven graft material of claim 14 , wherein the bioabsorbable non-woven graft material comprises interconnecting pores.
23. The bioabsorbable non-woven graft material of claim 14 , the bioabsorbable non-woven graft material comprising a surface pattern.
24. The bioabsorbable non-woven graft material of claim 23 , wherein the surface pattern comprises a repeating non-random pattern.
25. The bioabsorbable non-woven graft material of claim 14 , wherein the first electrospun non-woven fiber composition and the second electrospun non-woven fiber composition are uniformly distributed throughout the bioabsorbable non-woven graft material.
26. The bioabsorbable non-woven graft material of claim 14 , wherein the first electrospun non-woven fiber composition and the second electrospun non-woven fiber composition comprises an average diameter not greater than 5,000 nanometers.
27. A bioabsorbable non-woven graft material for facilitating regeneration of tissue, the bioabsorbable non-woven graft material comprising:
a single layer non-woven electrospun polymeric scaffold configured to facilitate tissue growth within the single layer non-woven electrospun polymeric scaffold wherein the single layer non-woven electrospun polymeric scaffold is configured to be bioabsorbed whereby the facilitated tissue growth remains after the single layer non-woven electrospun polymeric scaffold is bioabsorbed, the single layer non-woven electrospun polymeric scaffold comprising:
a first electrospun non-woven fiber composition, wherein the first electrospun non-woven fiber composition comprises a first polymer comprising glycolic acid; and
a second electrospun non-woven fiber composition, wherein the second electrospun non-woven fiber composition comprises a second polymer comprising caprolactone,
wherein the first electrospun non-woven fiber composition and the second electrospun non-woven fiber composition comprise different polymers,
wherein the first electrospun non-woven fiber composition and the second electrospun non-woven fiber composition are electrospun to form the single layer non-woven electrospun polymeric scaffold of the bioabsorbable non-woven graft material to create an architecture resembling a native extracellular matrix,
wherein the bioabsorbable non-woven graft material is configured to be attached to the tissue, and wherein the bioabsorbable non-woven graft material is configured to facilitate regeneration of the tissue,
wherein the bioabsorbable non-woven graft material further comprises a first region and a second region,
wherein the bioabsorbable non-woven graft material further comprises a plurality of pores formed among the first electrospun non-woven fiber composition and the second electrospun non-woven fiber composition,
wherein a density of the first region is less than a density of the second region,
wherein the single non-woven electrospun polymeric scaffold is sufficiently flexible for applying the bioabsorbable non-woven graft material to tissue, the non-woven electrospun polymeric scaffold has sufficient mechanical strength for the bioabsorbable non-woven graft material to be suturable, and the non-woven electrospun polymeric scaffold has sufficient mechanical strength for the bioabsorbable non-woven graft material to be trimmable,
wherein the bioabsorbable non-woven graft material comprises a suture pull-out strength, the suture pull-out strength ranging from 1 Newton to about 5 Newtons of force required for a suture to be torn from bioabsorbable non-woven graft material,
wherein the bioabsorbable non-woven graft material does not comprise more than one non-woven electrospun polymeric scaffold.
28. The bioabsorbable non-woven graft material of claim 27 , wherein the tissue comprises one or more of dura mater, pericardium, small intestinal submucosa, dermis, epidermis, tendon, trachea, heart valve leaflet, gastrointestinal tract, and cardiac tissue.
29. The bioabsorbable non-woven graft material of claim 27 , wherein the bioabsorbable non-woven graft material is configured to be attached to the tissue using one or more sutures.
30. The bioabsorbable non-woven graft material of claim 28 , wherein the bioabsorbable non-woven graft material comprises one or more hollow hole depression areas.
31. The bioabsorbable non-woven graft material of claim 30 , wherein the bioabsorbable non-woven graft material is configured to receive the one or more sutures in the bioabsorbable non-woven graft material through the one or more depression areas.
32. The bioabsorbable non-woven graft material of claim 27 , wherein the bioabsorbable non-woven graft material is configured to be attached to the tissue using one or more adhesives.
33. The bioabsorbable non-woven graft material of claim 27 , wherein the bioabsorbable non-woven graft material comprises a structure of fibers that are interlaid in an arrangement to create the architecture resembling the native extracellular matrix.
34. The bioabsorbable non-woven graft material of claim 27 , wherein the bioabsorbable non-woven graft material comprises one or more pores to promote cell infiltration.
35. The bioabsorbable non-woven graft material of claim 27 , wherein the bioabsorbable non-woven graft material comprises interconnecting pores.
36. The bioabsorbable non-woven graft material of claim 27 , the bioabsorbable non-woven graft material comprising a surface pattern.
37. The bioabsorbable non-woven graft material of claim 36 , wherein the surface pattern comprises a repeating non-random pattern.
38. The bioabsorbable non-woven graft material of claim 27 , wherein the first electrospun non-woven fiber composition and the second electrospun non-woven fiber composition are uniformly distributed throughout the bioabsorbable non-woven graft material.
39. The bioabsorbable non-woven graft material of claim 27 , wherein the first electrospun non-woven fiber composition and the second electrospun non-woven fiber composition comprises an average diameter not greater than 5,000 nanometers.
40. The bioabsorbable non-woven graft material of claim 1 , wherein the first region is a top surface and the second region is a bottom surface.
41. The bioabsorbable non-woven graft material of claim 1 , wherein the first region is a bottom surface and the second region is a top surface.
42. The bioabsorbable non-woven graft material of claim 13 , wherein the first region is a top surface and the second region is a bottom surface.
43. The bioabsorbable non-woven graft material of claim 13 , wherein the first region is a bottom surface and the second region is a top surface.
44. The bioabsorbable non-woven graft material of claim 27 , wherein the first region is a top surface and the second region is a bottom surface.
45. The bioabsorbable non-woven graft material of claim 27 , wherein the first region is a bottom surface and the second region is a top surface.
46. The bioabsorbable non-woven graft material of claim 1 , wherein the bioabsorbable non-woven graft material further comprises a top surface and a bottom surface, wherein the top surface or bottom surface comprises a plurality of protrusions.
47. The bioabsorbable non-woven graft material of claim 13 , wherein the bioabsorbable non-woven graft material further comprises a top surface and a bottom surface, wherein the top surface or bottom surface comprises a plurality of protrusions.
48. The bioabsorbable non-woven graft material of claim 27 , wherein the bioabsorbable non-woven graft material further comprises a top surface and a bottom surface, wherein the top surface or bottom surface comprises a plurality of protrusions.