Artificial Cornea and Method of Making Same
The present invention is an artificial cornea designed to restore vision in patients who are not candidates to receive a natural cornea transplant (allograft). The present device construction involves the use of a biocompatible, non-porous optic disk intimately bonded to one or more anchoring layers of porous polymeric material, and a unique sealing region which enhances sealing of the artificial cornea in the recipient's eye.
1 . An artificial cornea comprising:
a disk comprising polymeric corneal substitute material having anterior and posterior surfaces, said disk having a protrusion comprising an optical surface on said anterior surface;
a mechanical anchoring region comprising (1) an annular layer having an inner opening, said annular layer comprising a polymeric material oriented on the anterior surface of said disk so that the inner opening of the annular layer is oriented around said protrusion, and (2) a second layer comprising a polymeric material oriented on the posterior surface of the disk; and
a sealing region around the perimeter of the optical surface.
2 . The artificial cornea of claim 1 , wherein said sealing region comprises a porous material.
3 . The artificial cornea of claim 1 , wherein said sealing region comprises a non-porous material having at least some surface features thereon.
4 . The artificial cornea of claim 1 , wherein said sealing region comprises a porous material having at least some surface features thereon.
5 . The artificial cornea of claim 1 , wherein said sealing region comprises a porous material and at least a portion of the porosity is filled with a second material selected from the group consisting of a biodegradable material, a drug and a cell growth enhancer.
6 . The artificial cornea of claim 1 , wherein said sealing region comprises an annular sealing layer comprising a porous fluoropolymer.
7 . The artificial cornea of claim 1 , wherein the annular layer and the sealing region comprise a single continuous material.
8 . The artificial cornea of claim 1 , wherein said sealing region comprises a continuous layer across the optical surface.
9 . The artificial cornea of claim 1 , wherein said sealing region comprises expanded PTFE.
10 . The artificial cornea of claim 8 , wherein said sealing region comprises expanded PTFE.
11 . The artificial cornea of claim 1 , wherein said polymeric corneal substitute material comprises a fluoropolymer.
12 . The artificial cornea of claim 1 , wherein said polymeric corneal substitute material comprises perfluoropolymer containing TFE as a comonomer.
13 . The artificial cornea of claim 13 , wherein said fluoropolymer comprises a copolymer of tetrafluoroethylene (TFE) and perfluoroalkylvinylether (PAVE).
14 . The artificial cornea of claim 13 , wherein said fluoropolymer comprises perfluoropolyether.
15 . The artificial cornea of claim 13 , wherein said fluoropolymer comprises a copolymer of TFE and hexafluoropropylene (FEP).
16 . The artificial cornea of claim 1 , wherein said polymeric corneal substitute material has a refractive index between about 1.2 and 1.6.
17 . The artificial cornea of claim 1 , wherein said polymeric corneal substitute material comprises at least one material selected from the group consisting of silicone, PMMA, hydrogel and polyurethane.
18 . The artificial cornea of claim 1 , wherein the polymeric corneal substitute material has a light transmission (visible wavelength) greater than 50%.
19 . The artificial cornea of claim 1 , wherein the polymeric corneal substitute material has a light transmission (visible wavelength) greater than 80%.
20 . The artificial cornea of claim 1 , wherein said annular layer and said second layer comprise expanded PTFE.
21 . The artificial cornea of claim 1 , further comprising at least one reinforcing member within at least a portion of said disk.
22 . The artificial cornea of claim 1 , wherein said artificial cornea further comprises at least one through-path in the disk.
23 . The artificial cornea of claim 22 , wherein said at least one through-path extends through the disk and through the first annular layer and the second layer.
24 . An artificial cornea comprising:
a disk comprising polymeric corneal substitute material having anterior and posterior surfaces, said disk having a first protrusion comprising an optical surface on said anterior surface and a second protrusion on said posterior surface;
a mechanical anchoring region comprising (1) a first annular layer having an inner opening, said first annular layer comprising a first polymeric material oriented on the anterior surface of said disk so that the inner opening of the first annular layer is oriented around said first protrusion, and (2) a second annular layer having an inner opening, said second annular layer comprising a second polymeric material oriented on the posterior surface of said disk so that the inner opening of the second annular layer is oriented around said second protrusion; and
a sealing region around the perimeter of the optical surface.
25 . The artificial cornea of claim 24 , wherein said sealing region comprises a porous material.
26 . The artificial cornea of claim 24 , wherein said sealing region comprises a non-porous material having at least some surface features thereon.
27 . The artificial cornea of claim 24 , wherein said sealing region comprises a porous material having at least some surface features thereon.
28 . The artificial cornea of claim 24 , wherein said sealing region comprises a porous material and at least a portion of the porosity is filled with a second material selected from the group consisting of a biodegradable material, a drug and a cell growth enhancer.
29 . The artificial cornea of claim 24 , wherein said sealing region comprises an annular layer of a porous fluoropolymer.
30 . The artificial cornea of claim 24 , wherein the first annular layer and the sealing region comprise a single continuous material.
31 . The artificial cornea of claim 24 , wherein said sealing region comprises a continuous layer across the optical surface.
32 . The artificial cornea of claim 24 , wherein said sealing region comprises expanded PTFE.
33 . The artificial cornea of claim 29 , wherein said sealing region comprises expanded PTFE.
34 . The artificial cornea of claim 24 , wherein said polymeric corneal substitute material comprises a fluoropolymer.
35 . The artificial cornea of claim 24 , wherein said polymeric corneal substitute material comprises perfluoropolymer containing TFE as a comonomer.
36 . The artificial cornea of claim 36 , wherein said fluoropolymer comprises a copolymer of tetrafluoroethylene (TFE) and perfluoroalkylvinylether (PAVE).
37 . The artificial cornea of claim 36 , wherein said fluoropolymer comprises a copolymer of TFE and hexafluoropropylene (FEP).
38 . The artificial cornea of claim 35 , wherein said fluoropolymer comprises perfluoropolyether.
39 . The artificial cornea of claim 24 , wherein said polymeric corneal substitute material has a refractive index between about 1.2 and 1.6.
40 . The artificial cornea of claim 24 , wherein said polymeric corneal substitute material comprises at least one material selected from the group consisting of silicone, PMMA, hydrogel and polyurethane.
41 . The artificial cornea of claim 24 , wherein the polymeric corneal substitute material has a light transmission (visible wavelength) greater than 50%.
42 . The artificial cornea of claim 24 , wherein the polymeric corneal substitute material has a light transmission (visible wavelength) greater than 80%.
43 . The artificial cornea of claim 24 , wherein said first annular layer and said second annular layer comprise expanded PTFE.
44 . The artificial cornea of claim 24 , further comprising at least one reinforcing member within at least a portion of said disk.
45 . The artificial cornea of claim 24 , wherein said artificial cornea further comprises at least one through-path in the disk.
46 . The artificial cornea of claim 45 , wherein said at least one through-path extends through the disk and through the first and second annular rings.
47 . An artificial cornea comprising:
a disk comprising polymeric corneal substitute material having anterior and posterior surfaces, said disk having a first protrusion comprising an optical surface on said anterior surface and a second protrusion on said posterior surface;
a first porous annular layer having an inner opening, said first annular layer comprising a first polymeric material oriented on the anterior surface of said disk so that the inner opening of the first annular layer is oriented around said first protrusion;
a second porous annular layer having an inner opening, said second annular layer comprising a second polymeric material oriented on the posterior surface of said disk so that the inner opening of the second annular layer is oriented around said second protrusion; and
a sealing region around the perimeter of the optical surface.
48 . An artificial cornea comprising:
a disk comprising a polymeric corneal substitute material having anterior and posterior surfaces, said disk having on said anterior surface an optical surface;
a mechanical anchoring means; and
a sealing region around the perimeter of the optical surface.
49 . The artificial cornea of claim 48 , wherein said sealing region comprises an annular layer of a porous fluoropolymer.
50 . The artificial cornea of claim 48 , wherein said sealing region comprises a continuous layer across the optical surface.
51 . The artificial cornea of claim 48 , wherein said polymeric corneal substitute material comprises a fluoropolymer.
52 . The artificial cornea of claim 51 , wherein said fluoropolymer comprises at least one material selected from the group consisting of a copolymer of tetrafluoroethylene (TFE) and perfluoroalkylvinylether (PAVE), a copolymer of tetrafluoroethylene (TFE) and hexafluoropropylene (PAVE), and perfluoropolyether.
53 . The artificial cornea of claim 48 , wherein said polymeric corneal substitute material has a refractive index between about 1.2 and 1.6.
54 . The artificial cornea of claim 48 , wherein said polymeric corneal substitute material comprises at least one material selected from the group consisting of silicone, PMMA, hydrogel and polyurethane.
55 . The artificial cornea of claim 48 , wherein the polymeric corneal substitute material has a light transmission (wavelength 350-750 nm) greater than 50%.
56 . The artificial cornea of claim 48 , wherein the polymeric corneal substitute material has a light transmission (wavelength 350-750 nm) greater than 80%.
57 . The artificial cornea of claim 48 , wherein said sealing region comprises expanded PTFE.
58 . The artificial cornea of claim 49 , wherein said sealing region comprises expanded PTFE.
59 . The artificial cornea of claim 50 , wherein said sealing region comprises expanded PTFE.
60 . The artificial cornea of claim 48 , further comprising at least one reinforcing member within at least a portion of said disk.
61 . The artificial cornea of claim 48 , wherein said sealing region comprises a non-porous material having at least some surface features thereon.
62 . The artificial cornea of claim 48 , wherein said sealing region comprises a porous material having at least some surface features thereon.
63 . The artificial cornea of claim 48 , wherein said sealing region comprises a porous material and at least a portion of the porosity is filled with a second material selected from the group consisting of a biodegradable material, a drug and a cell growth enhancer.
64 . The artificial cornea of claim 48 , wherein said artificial cornea further comprises at least one through-path in the disk.
65 . The artificial cornea of claim 48 , wherein said at least one through-path extends through the disk and through the mechanical anchoring means.