Materials, devices, and methods for in-situ formation of composite intervertebral implants
An intervertebral disc repair devices is disclosed that includes a porous matrix and a polymerizable material. The intervertebral disc repair device is advantageous because it may be injected through a small annulus defect, it can form an implant larger than the annulus defect for improved expulsion resistance, it has increased toughness and durability because of the porous matrix, and it conforms to the partially or fully evacuated disc space during insertion or packing.
1 . An intervertebral disc repair device comprising:
a porous matrix;
and a polymerizable material.
2 . The device as in claim 1 , wherein the polymerizable material is injected into the porous matrix after the matrix is inserted into an evacuated disk space.
3 . The device as in claim 1 , wherein the porous matrix is contacted with the polymerizable material before the porous matrix is inserted into an evacuated disk space.
4 . The device as in claim 1 , wherein the polymerizable material is injected into the porous matrix after the matrix is inserted into an unevacuated disk space.
5 . The device as in claim 1 , wherein the porous matrix is contacted with the polymerizable material before the porous matrix is inserted into an unevacuated disk space.
6 . The device as in claim 1 , wherein the polymerizable material is selected from the group consisting of polyurethanes, polyvinyl alcohols (PVA), PVA hydrogels, collagen, fibrin, heparin, keratin, albumin, silk, elastin, polyvinylpyrrolidone (PVP), PVP hydrogels, polyethylene glycol (PEG), PEG hydrogels, acrylamide hydrogels, acrylamide/maleic acid hydrogels, acrylic based hydrogels, polyalkylimines, silicone elastomers, polymethylmethacrylates, and mixtures and combinations thereof
7 . The device as in claim 1 , wherein the polymerizable material is a water activated polymerizable material.
8 . The device as in claim 7 , wherein the water activated polymerizable material is a siloxane with a functional group that allows polymerization of the siloxane with water.
9 . The device as in claim 8 , wherein the water activated siloxane has alkoxy, acyloxy, acetoxy, amido, oximo, or amino functional groups.
10 . The device as in claim 9 , wherein the water activated polymerizable material is a polyfunctional isocyanate based polymerizable material.
11 . The device as in claim 1 , wherein the polymerizable material is a two-part polymerizable material.
12 . The device as in claim 11 , wherein the first part of the two-part polymerizable material is a solid.
13 . The device as in claim 12 , wherein the two-part polymerizable material forms a polyurethane and has as one part a diisocyanate or polymeric isocyanate and as the other part a polyol.
14 . The device as in claim 13 , wherein the two-part polymerizable material forms a silicone polyurethane.
15 . The device as in claim 13 , wherein the diisocyanate is selected from the group consisting of 2,4′-diphenylmethane diisocyanate, 4,4′-diphenylmethane diisocyanate, 2,2′-diphenylmethane diisocyanate, 2,4-toluene diisocyanate, 2,6-toluene diisocyanate, hexamethylene diisocyanate, dicyclohexylmethane diisocyanate, and mixtures thereof.
16 . The device as in claim 13 , wherein the polyol is selected from the group consisting of polycaprolactone polyols, polycarbonate polyols, polyester polyols, polytetrahydrofuran polyol, and mixtures thereof.
17 . The device as in claim 13 , wherein a catalyst is added to one of the two parts of the polymerizable material forming a polyurethane.
18 . The device as in claim 17 , wherein the catalyst is selected from the group consisting of tin esters, tin alkylesters, tin mercaptides, amines, tertiary amines, dibutyl tin dilaurate, and mixtures thereof.
19 . The device as in claim 13 , wherein low molecular weight diols are added to one part of the two-part polymerizable material forming a polyurethane.
20 . The device as in claim 11 , wherein the two-part polymerizable material has as one part mixtures of poly(hydroxyalkyl(meth)acrylates) and poly(alkyl(meth)acrylates) and as the other part polyfunctional (meth)acrylate monomers or oligomers.
21 . The device as in claim 20 , wherein the polymerizable material is cured using a free radical initiator and an amine activator.
22 . The device as in claim 11 , wherein the two-part polymerizable material has as one-part mixtures of tetra and trifunctional epoxy resin and as the other part a multifunctional amine or amino terminated elastomer.
23 . The device as in claim 11 , wherein the two-part polymerizable material is a polymer complex of polyanions or polycations.
24 . The device as in claim 23 , wherein the polymer complex of polyanions is selected from the group consisting of sodium carboxymethyl cellulose, sodium cellulose sulphate, sodium alginate, sodium hyaluronate, and mixtures thereof.
25 . The device as in claim 23 , wherein the polymer complex of polycations is selected from the group consisting of chitosan, quaternised chitosan, amino alkylated and subsequently quarternised cellulose, poly-L-lysine, and mixtures thereof.
26 . The device as in claim 1 , wherein the polymerizable material is a light activated polymerizable material.
27 . The device as in claim 26 , wherein the light activated polymerizable material comprises a mixture of a polyfunctional urethane acrylate or polyfunctional urethane methacrylate and a polyfunctional acrylate resin.
28 . The device as in claim 26 , wherein the light activated polymerizable material comprises a mixture of 2,2-bis-(4-(2-hydroxy-3-methacryloyloxypropoxy)phenyl) propane and a photoinitiation system.
29 . The device as in claim 26 , wherein the light activated polymerizable material comprises a one-part system of triisocyanates or higher isocyanates and OH-functional acrylates or methacrylates.
30 . The device as in claim 1 , wherein the polymerizable material is a heat activated polymerizable material.
31 . The device as in claim 1 , wherein the polymerizable material is in a state selected from the group consisting of a liquid, gel, colloid, paste, suspension, powder, grain, or granule.
32 . The device as in claim 1 , wherein the porous matrix is in the form of a woven or non-woven mesh, sheeting, braided or unbraided tubing, woven or non-woven fabric, or a sponge.
33 . The device of claim 1 , wherein the porous matrix is selected from the group consisting of polyethylenes including ultra high molecular weight polyethylenes, polyesters, polyetheretherketone, polyurethanes, polyesterurethane, polyester/polyol block copolymers, poly ethylene terepthalate, polytetrafluoro ethylene polyesters, nylons, polysulphanes, cellulose materials, polyaramids, carbon or glass fibers, polyvinyl chlorides, stryrenic resins, polypropylenes, polycarbonates, acrylonitrile-butadiene-styrene (“ABS”), acrylics, styrene acrylonitriles, and mixtures, copolymers, and mixtures thereof.
34 . A method for intervertebral disc repair comprising:
inserting a porous matrix into an at least partially evacuated disc space;
injecting a polymerizable material into the porous matrix;
and allowing the polymerizable material to polymerize in situ.
35 . A method as in claim 34 , wherein the polymerizable material is injected into the porous matrix using a hypodermic needle or cannula.
36 . A method as in claim 34 , wherein allowing the polymerizable material to cure in situ comprises allowing body fluids to contact the polymerizable material, applying light to the polymerizable material, or applying heat to the polymerizable material.
37 . A method for intervertebral disc repair comprising:
contacting a porous matrix with a polymerizable material;
inserting the porous matrix into an at least partially evacuated disc space; and
allowing the polymerizable material to polymerize in situ.
38 . A method as in claim 37 , wherein allowing the polymerizable material to cure in situ comprises allowing body fluids to contact the polymerizable material, applying light to the polymerizable material, or applying heat to the polymerizable material.
39 . A method for intervertebral disc repair comprising:
contacting a porous matrix with saline solution or water;
contacting the porous matrix with a water activated polymerizable material;
inserting the porous matrix into an at least partially evacuated disc space; and
allowing the water activated polymerizable material to polymerize in situ.
40 . A method for intervertebral disc repair comprising:
contacting a porous matrix with a first part of a two-part polymerizable material;
inserting the porous matrix into an at least partially evacuated disc space;
injecting the complementary second part of the two-part polymerizable material into the porous matrix; and
allowing the two-part polymerizable material to cure in situ.
41 . The method as in claim 40 , wherein the second part of the two-part polymerizable material is injected into the porous matrix using a hypodermic needle or cannula.
42 . The method as in claim 34 , wherein the disk space is evacuated by curettage, suction, laser nucleotomy, or chemonucleolysis.
43 . The method as in claim 34 , wherein the porous matrix is inserted into the evacuated disk space using a relatively small cannula and a flexible, semi-rigid push rod to push the matrix through the cannula.
44 . A surgical kit, comprising:
a porous matrix,
a trimming device for sizing the porous matrix,
a polymerizable material, and
a device for injecting the polymerizable material.