NON-WOVEN GRAFT MATERIALS FOR NERVE REPAIR AND REGENERATION
Disclosed herein are non-woven graft materials for use in specialized surgical procedures involving nerve repair and regeneration. Some embodiments describe electrospun fiber products such as conduits, wraps, or grafts comprising a resorbable hybrid-scale matrix to facilitate nerve repair and regeneration.
1 . (canceled)
2 . A method for facilitating nerve repair and regeneration, the method comprising:
identifying injured nerve tissue in a patient;
surgically isolating the injured nerve tissue;
inserting a hybrid-scale fiber matrix to a target site; and
securing the hybrid-scale fiber matrix to the injured nerve tissue.
3 . The method of claim 2 , further comprising releasing one or more therapeutically active molecules or biological therapeutics via one or more of surface functionalization, bulk loading, physical entrapment, or progressive degradation over a defined period of time.
4 . The method of claim 2 , further comprises applying a solvent comprising at least one of HFIP, DMF, DCM, Acetone, Chloroform, THF, Acetic Acid, Formic Acid, Trifluoroethanol, or Ethyl acetate.
5 . The method of claim 2 , wherein the hybrid-scale fiber matrix comprises an inner fiber layer comprising uniaxially-aligned or longitudinally-aligned fibers and an outer fiber layer comprises randomly-aligned fibers, wherein the hybrid-scale fiber matrix comprises hybrid-scale fibers comprising fibers having a range of fiber diameters between 10 nm and 10,000 nm.
6 . The method of claim 2 , wherein the hybrid-scale fiber matrix is secured to the injured nerve tissue using one or more techniques including suturing, tissue adhesive, or gravity.
7 . The method of claim 2 , wherein the hybrid-scale fiber matrix for repairing injured nervous tissue, wherein the hybrid-scale fiber matrix is secured end-to-end or in-line with injured nerve tissue.
8 . The method of claim 2 , wherein the injured nerve tissue comprises a peripheral nerve.
9 . The method of claim 2 , wherein the method is used for at least one of wound repair, oral surgery, dermal repair and regeneration, head and neck surgery, endonasal surgery, and bone repair.
10 . The method of claim 2 , wherein the hybrid-scale fiber matrix comprises a shape geometry selected from a group consisting of a tube, a conduit, a graft, a wrap, or a spiral wrap.
11 . The method of claim 2 , wherein the hybrid-scale fiber matrix comprise hybrid-scale fibers comprising a resorbable polymer selected from a group of polymers comprising a combination of polycaprolactone, polylactic acid, polyglycolic acid, polydioxanone, PEO, PEG, and poly(3-hydroxybutyrate-co-3-hydroxyvalerate).
12 . The method of claim 2 , wherein the hybrid-scale fiber matrix comprise hybrid-scale fibers that comprise biologically derived and natural materials selected from a group of materials comprising at least one of collagen, elastin, laminin, or fibrin.
13 . The method of claim 2 , wherein the hybrid-scale fiber matrix comprise hybrid-scale fibers that are distributed in a bimodal distribution, wherein at least 25% of the hybrid-scale fibers possessing a diameter less than 1000 nm and at least 25% of fibers possessing a diameter greater than 1000 nm.
14 . The method of claim 2 , wherein the hybrid-scale fiber matrix comprises a mean pore size less than 300 μm 2 .
15 . The method of claim 2 , wherein the hybrid-scale fiber matrix comprise hybrid-scale fibers that are configured to progressively resorb over time in parallel with tissue regeneration and formation in a time period between 4 to 100 weeks.
16 . The method of claim 5 , wherein a total thickness of the inner fiber layer and the outer fiber layer comprises at least one of a range between 250 microns and 550 microns or a range between 100 microns and 600 microns.
17 . The method of claim 5 , wherein a thickness of the inner fiber layer ranges between 0 to 50% of a total thickness of both the inner fiber layer and the outer fiber layer.
18 . The method of claim 2 , wherein a tensile strength of the hybrid-scale fiber matrix is at least 10.5 N, a suture pullout strength of the hybrid-scale fiber matrix is at least 1 N, and a compressive strength of the hybrid-scale fiber matrix is greater than 0.25 N.
19 . The method of claim 5 , wherein the hybrid-scale fiber matrix comprises at least one of:
an inner diameter of the inner fiber layer is less than 2 microns, and an outer diameter of the outer fiber layer is between 1.5 mm and 10 mm,
a length of the hybrid-scale fiber matrix that is between 8 mm to 30 mm,
a length of the hybrid-scale fiber matrix is at least 5 mm,
20 . The method of claim 2 , wherein the hybrid-scale fiber matrix comprises a volumetric density of uniaxially aligned or longitudinally-aligned fibers that is at least one of: between 0-25%, wherein a mean pore size of the hybrid-scale fiber matrix is less than 300 μm 2 , or between 0-50%.
21 . The method of claim 5 , wherein the outer fiber layer comprises an outer lumen contacting an outer surface of the inner fiber layer, wherein an overhang defined by a difference in an end of the inner fiber layer and an end of the outer fiber layer is between 1-10 mm.