Use of amniotic membrane as biocompatible devices
Amniotic membranes with enhanced rigidity as biocompatible devices or with biocompatible devices that may be implanted to provide desirable features. The amniotic membrane may be included with one or more polymers that may be crosslinked to provide durability and ease of implantation. The amniotic membrane may be used to form the device, or it may be contained on or within a pre-existing device, such as an ocular shunt or contact lens.
1 . A biocompatible composition comprising an isolated amniotic membrane treated with at least one consistency-modifying component in an amount sufficient to enhance membrane rigidity of a non-treated amniotic membrane and at least one excipient.
2 . The composition of claim 1 wherein the component is at least one of a polymer or a crosslinking agent..
3 . The composition of claim 1 wherein the component is present in the composition in an amount ranging from about 0.01% w/w to about 99.99% w/w .
4 . The composition of claim 1 wherein the amniotic membrane is selected from at least one of human derived, non-human derived, or recombinant.
5 . The composition of claim 2 wherein the polymer is naturally occurring.
6 . The composition of claim 2 wherein the polymer is at least one of collagen, mucopolysaccharides, condroitin sulfate, laminin, elastin, fibroin, keratins, hyaluranic acid, integrin, glucosaminoglycan, proteoglycans, fibronectin, hyaluronan, starches, cellulose, agar, alginate, carrageenan, pectin, konjac, gums, chitan, sulfated chitan, chitosan, polylactic acid, polyhydroxyalkanoates, silks, collegin/gelatin, reslin, palamino acids, wheat gluten, casein, soy, zein, serum albumin, cellulose, xanthum, dextran, gellan, levan, curd lan, polygalactosamine, pullulan, elsinan, yeast glucans, acetoglycerides, waxes, emulsan, surfactants, lignin, tannin, humic acid, shellac, polygammaglutamic acid, or natural rubber.
7 . The composition of claim 2 wherein the polymer is synthetic.
8 . The composition of claim 2 wherein the polymer is at least one of hydrogel, hilafilcon, hilafilcon B, synthetic polymers made from natural fats and oils, polyethylene, poly(alkylcyanoacrylates), polybutylcyanoacrylates, polyhexylcyanoacrylates, polyethylcyanoacrylate, polyisobutylcyanoacrylate, polycyanoacylate, silica, poly(D,L-lactide-coglycolide, silicone, polyvinylpyrollidone, polyvinylalcohol, polycaprolactone, poly(glycolic acid) (PGA), poly(lactic acid) (PLA), copolymers of PGA and PLA, polydioxananone (PDS), poly(methylmethacrylate) (PMMA), poly(hydroxyethylmethacrylate) (HEMA), glyceroldimethacrylate (GDM), glycerol methacrylate (GMA), copolymerized PMMA with methacryloxypropyl tris(trimethysiloxy silane) (TRIS) PMMA-TRIS, MMA-TRIS doped with fluoromethacrylates, or polydimethylsiloxane (PDMS).
9 . The composition of claim 2 wherein the polymer is crosslinked.
10 . The composition of claim 1 wherein the concentration of amniotic membrane ranges from about 0.1% w/w to about 100% w/w .
11 . The composition of claim 1 being molded and cured to form a device.
12 . The composition of claim 1 capable of forming at least one of an ocular shunt or a contact lens.
13 . The composition of claim 1 capable of forming at least part of a biocompatible device or of attaching to a preformed biocompatible device without suturing.
14 . The composition of claim 1 wherein the component is radiation.
15 . An insertable or implantable medical device comprising an isolated amniotic membrane treated with at least one consistency-modifying component to provide enhanced membrane rigidity.
16 . The device of claim 15 wherein the amniotic membrane is treated with at least one crosslinkable biocompatible polymer to form an amniotic membrane-polymer composition.
17 . The device of claim 15 wherein the treated membrane forms the device or is contained on at least a portion of the device without suturing.
18 . The device of claim 15 further comprising a drug.
19 . A medical device comprising an isolated amniotic membrane treated with at least one isolated polymer to form a treated membrane having enhanced rigidity, said polymer in an amount sufficient to shape said treated membrane for insertion or implantation at an anatomical site.
20 . The device of claim 19 wherein the device is inserted or implanted without suturing to the anatomical site.
21 . The device of claim 19 wherein the anatomical site is the eye.
22 . The device of claim 19 further comprising a drug.
23 . An implantable or insertable medical device consisting essentially of an isolated amniotic membrane-biocompatible polymer composition to enhance rigidity of the amniotic membrane rendering the amniotic membrane capable of forming a device for implantation or insertion within an anatomical site.
24 . The device of claim 23 forming at least one of an ocular shunt, a contact lens, or a portion of a blood vessel.
25 . The device of claim 23 wherein the polymer is at least one of collagen, mucopolysaccharides, condroitin sulfate, laminin, elastin, fibroin, keratins, hyaluranic acid, integrin, glucosaminoglycan, proteoglycans, fibronectin, hyaluronan, starches, cellulose, agar, alginate, carrageenan, pectin, konjac, gums, chitan, sulfated chitan, chitosan, polylactic acid, polyhydroxyalkanoates, silks, collegin/gelatin, reslin, palamino acids, wheat gluten, casein, soy, zein, serum albumin, cellulose, xanthum, dextran, gellan, levan, curd lan, polygalactosamine, pullulan, elsinan, yeast glucans, acetoglycerides, waxes, emulsan, surfactants, lignin, tannin, humic acid, shellac, polygammaglutamic acid, natural rubber, hydrogel, hilafilcon, hilafilcon B, synthetic polymers made from natural fats and oils, polyethylene, poly(alkylcyanoacrylates), polybutylcyanoacrylates, polyhexylcyanoacrylates, polyethylcyanoacrylate, polyisobutylcyanoacrylate, polycyanoacylate, silica, poly(D,L-lactide-coglycolide, silicone, polyvinylpyrollidone, polyvinylalcohol, polycaprolactone, poly(glycolic acid) (PGA), poly(lactic acid) (PLA), copolymers of PGA and PLA, polydioxananone (PDS), poly(methylmethacrylate) (PMMA), poly(hydroxyethylmethacrylate) (HEMA), glyceroldimethacryl ate (GDM), glycerol methacrylate (GMA), copolymerized PMMA with methacryloxypropyl tris(trimethysiloxy silane) (TRIS) PMMA-TRIS, MMA-TRIS doped with fluoromethacrylates, or polydimethylsiloxane (PDMS).
26 . A method of forming a biocompatible device comprising shaping an amniotic membrane-polymer composition with enhanced rigidity to fit an anatomical site requiring the device to form an implantable or insertable form-fitting device.
27 . The method of claim 26 wherein at least one of the amniotic membrane or polymer is crosslinked.
28 . The method of claim 27 wherein crosslinking is by at least one of chemical crosslinking, photocrosslinking, or radiation crosslinking.
29 . The method of claim 26 wherein the device is an ocular device.
30 . The method of claim 26 wherein the device is at least one of a therapeutic contact lens, a refractive contact lens, an intraocular lens, or a corneal lens inlay.
31 . The method of claim 26 wherein the device contains at least one drug.
32 . The method of claim 31 wherein the drug is provided in the composition.
33 . The method of claim 31 wherein the drug is provided to the device.
34 . The method of claim 31 wherein the drug is at least one of an antiproliferative drug, an antineoplastic drug, an antimicrobial, a steroid, a growth stimulatory factor, a growth inhibitory factor, a hormone, an antibody, or an immunomodulator.
35 . A method to reduce a proliferative response to an implanted or inserted synthetic medical device comprising providing at least a portion of the synthetic medical device with an isolated amniotic membrane composition treated to have enhanced membrane rigidity to provide a physiological surface and thereby reduce a proliferative response.
36 . The method of claim 35 wherein the amniotic membrane composition further comprises at least one of a polymer or a crosslinking agent
37 . A method to provide a biocompatible implantable or insertable device comprising enhancing rigidity of an isolated amniotic membrane by providing a consistency-modifying component to the isolated amniotic membrane in a concentration sufficient to enhance rigidity of the amniotic membrane and forming a three-dimensional biocompatible implantable or insertable device from the membrane with enhanced rigidity.
38 . The method of claim 37 wherein the consistency-modifying component is at least one of a polymer, radiation, a photocrosslinker, or a chemical crosslinker.
39 . The method of claim 37 wherein the device is an ocular device.