AU710038B2

AU710038B2 - Intraocular prostheses

Info

Publication number: AU710038B2
Application number: AU61671/94A
Authority: AU
Inventors: Jean T. Jacob-Labarre
Original assignee: JACOB LABARRE JEAN T
Current assignee: JACOB LABARRE JEAN T
Priority date: 1987-07-07
Filing date: 1994-01-28
Publication date: 1999-09-09
Anticipated expiration: 2014-01-28
Also published as: AU6167194A

Description

CD/99187022.3 1 INTRAOCULAR

PROSTHESES

Field of Invention This invention relates to intraocular optical lenses and other ocular prostheses within the human orbital space. More particularly, this invention relates to prostheses which contain in part a physical barrier against pathogen travel transversing across the prosthesis body, a prosthesis for replacing a part of the cornea of the eye which has suffered for example severe corneal damage, a part of the eye wall, and relates to a prosthesis for replacing the posterior lens of the eye which has variable power.

Prior Art and General Background For information about the prior art and general background, please see, for example, U.S. Patent No. 4,932,968 or U.S. Patent No. 5,282,851.

General, Summary Discussion of the Invention It is known in the art to provide ocular prostheses which include an 15 elastomeric optical element having an annular skirt which surrounds the periphery of the element. Included with the skirt is an annular porous portion.

The optical element is

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WO 95/20367 PCT/US94/01016 -2attached to the skirt by interpenetration of the periphery of the optical element into the pores of the porous portion.

The optical element may include convex anterior and posterior surfaces for replacement of the diseased or injured corneal button of the eye. An annular porous portion extending radially outwardly to periphery of the skirt is disposed in a lamellar incision which extends annularly into the stroma of the cornea surrounding the corneal button which is to be replaced.

A plurality of porous extensions, which may be six, extend radially outward from the periphiery of the skirt and are located in tunnels extending radially through the limbus into the sclera. The extensions are entirely embedded and are not exposed to the atmosphere and allow forward progression of fluid by means of their pores from the anterior chamber of the eye to the sclera, thus allowing adequate nutrition of the sclera while avoiding degeneration of any remaining corneal stroma.

Tissue ingriowth into the pores of the porous portion connects and surrounds the prosthesis to the remaining corneal tissues, thus preventing aqueous fluid from leaking past the implant while allowing no direct path for pathogens into the eye.

The optical element may include biconvex anterior and posterior surfaces for replacement of the posterior lens of the eye between the iris and the vitreous body. Firstly, a small incision is made. Secondly, the natural lens of the eye can then be removed by any method such as lensectomy or cryoextraction. Thirdly, the prosthesis is inserted through the incision and the opening in the iris and manipulated into the capsular bag.

The removal of the natural lens forms a void in the eye which is surrounded by the lens capsule, in which the prosthesis may be located, with its annular skirt in contact with the internal surface of the lens capsule (or capsular bag). Once the prosthesis has been manipulated CD/99187022.3 3 into position, the incision may be sutured closed, allowing the prosthesis to stabilise in the lens capsule, and to connect to the lens capsule through fibrous ingrowth into the pores of the porous portion of the skirt.

An ocular prosthesis can be made for use as an implant within the eye or on the outer surface, at least in part of a non-resorbable non-dissolving porous polymer material for forming a tissue attachment and/or ingrowth within the eye.

The prosthesis body can have tissue ingrowth and/or tissue adhesion means for forming a bond between the eye tissue and the prosthesis wherein the body and ingrowth means comprise a portion formed of a porous polymer material.

A total ocular prosthesis comprises a prosthesis body that includes in part a coating or layer of a porous polymer for forming a tissue ingrowth and/or adhesion attachment with ocular muscles. The polymer is preferably of a polymer material that will not unravel when cut.

o* Each prosthesis is adapted to form attachment to eye muscle tissue. One 15 prosthesis can be an ocular replacement with muscle attachment sites thereon.

The prosthesis can include means thereon for scleral reinforcement. The prosthesis can be in the form of a scleral buckle. The prosthesis can be in the form of a glaucoma drain.

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In one embodiment of the present invention, the polymer forms a porous S 20 layer and there is an adjacent non-porous layer so that a barrier is defined against bacterial penetration or fluid leakage. The non-porous layer can be an internal layer with porous polymer on both sides thereof. The non-porous layer is preferably of a polymer material. The non-porous layer is preferably a non-porous polyurethane.

In a preferred embodiment of the present invention, an ocular prosthesis for use as an implant within the eye socket region of a patient, within the patient's eye or on the outer surface of the patient's eye, comprises a prosthesis body that is positioned during use in the eye socket region of a patient's body, the region being exposed.

WO 95/20367 PCT/US94/01016 -4to the external environment and to the threat of pathogen travel from outside the patient's body. The prosthesis body includes tissue attachment means that includes a nonresorbable, non-dissolving porous polymer material with a pore size greater than 20 microns, and the pores of the porous polymer material form a tissue attachment site on a first outer surface of the prosthesis that allows tissue ingrowth by surrounding ocular tissue. The prosthesis body includes a solid or closed-pore polymer layer coextensive with the tissue attachment site that forms a barrier against generally transverse fluid or pathogen travel from second outer surface 1 o e a first outer surface, to the tissue attachment site.

In another preferred embodiment of the present invention, an ocular prosthesis for use as an implant within the eye socket region of a patient, within the patient's eye or on the outer surface of the patient's eye comprises a prosthesis body having tissue adhesion means on a first outer surface of the prostheis body for forming a bond between the eye tissue and the prosthesis, the tissue adhesion means comprising a portion formed of a porous polymer material having pores that enable connection to surrounding ocular tissue, the pores of the polymer defining a tissue attachment site. The prosthesis body has means for impeding fluid leakage past the implant at the tissue attachment site. The means for impeding comprises a portion formed of a solid or closed-pore polymer material coextensive with the tissue attachment site so that a barrier is formed against generally transverse fluid and pathogen penetration from a second outer surface, which opposes the first outer surface, to the tissue attachment site.

In a third preferred embodiment of the present invention, an ocular prosthesis comprises a prosthesis body that includes a first outer surface of a porous polymer material having a pore size of about twenty to ninety microns for forming a tissue adhesion surface defining WO 95/20367 PCT/US94/01016 a tissue attachment site for attachment of surrounding ocular tissue. The body has a means for impeding fluid and pathogens from leaking past the implant at the tissue attachment site. The means for impeding comprises a portion formed of a solid or closed-pore polymer material coextensive with the tissue attachment site so that a barrier is formed against generally transverse fluid and pathogen penetration from a second outer surface, which opposes the first outer surface, to the tissue attachment site.

In any of these three preferred embodiments, the plLer is preferably. a material that Will not unravel when cut. Further, preferably the polymer forms a porous layer and there is an adjacent non-porous layer so that a barrier is defined against bacterial penetration or fluid leakage.

In such a case, the non-porous layer is preferably a nonporous polyurethane.

In any of the preferred embodiments, the prosthesis is preferably made from any of the following polymer families: polyether polyurethanes, polysiloxanes, polyacrylonitriles, polyesters (saturated), polyethylenes, polyethylene terphthalates, polyacrylates, polyvinyl pyrrolidone, polymethacrylates, polytetrafluoroethylenes, or a copolymer of any of these.

In any of the preferred embodiments, the porous polymer material preferably comprises a material from the group consisting of polyurethane, polyethylene, polypropylene-polybutylene copolymer, polytetrafluoroethylene, and an acrylate based polymer.

The porous polymer material can be an expanded polymer foam, fabric or mesh, and the solid polymer layer is preferably substantially impermeable to fluids.

The present invention preferably includes an ocular prosthesis for use as an implant within the eye socket region of a patient, within the patient's eye or on the outer surface of the patient's eye, comprising a prosthesis body that is positioned during use in the eye socket region WO 95/20367 PCT/US94/01016 -6of a patient's body, the region being exposed to the external environment and to the threat of pathogen travel from outside the patient's body. The prosthesis body preferably includes tissue attachment means that includes a non-resorbable, non-dissolving porous polymer material wherein the pores of the polymer form a tissue attachment tissue ingrowth to surrounding ocular tissue defining a tissue attachment site.

The present invention can also include an ocular prosthesis for use as an implant within the eye socket region of a patient, within the patient's eye or on the outer surface of 1s eye L.LmpL.L±ing a prosthesis body having tissue ingrowth and/or tissue adhesion means for forming a bond between the eye tissue and the prosthesis, wherein the tissue ingrowth or tissue adhesion means comprises in part a portion formed of a porous polymer material having pores that enable connection to surrounding ocular tissue wherein the pores of the polymer define a tissue attachment site; the combination of the prosthesis body and surrounding attached tissue form a means for impeding fluid from leaking past the implant at the tissue attachment site.

The present invention can include an ocular prosthesis comprising a prosthesis body that includes an outer layer of a porous polymer material having a pore size of about twenty to ninety (20-90) microns for forming a tissue ingrowth or adhesion attachment with surrounding ocular tissue, the body and attached tissue defining a means for impeding fluid and/or pathogens from leaking past the implant at the tissue attachment site.

The polymer is preferably of a material that will not unravel when cut. Preferably, the polymer forms a porous layer and there is an adjacent non-porous layer so that a barrier is defined against bacterial penetration or fluid leakage. In such a case, the non-porous layer can preferably be a non-porous polyurethane.

The pore size is preferably about 20-90 microns, and WO 95/20367 PCT/US94/01016 -7the porous polymer material preferably comprises a material from the group consisting of polyurethane, polypropylenepolybutylene copolymer, polytetrafluoroethylene, and an acrylate based polymer.

The prosthesis body (including the tissue attachment site with its porous and non-porous layers) can be made by injection or pressure molding, solvent casting, or electrostatic deposition of the polymer materials together.

The porous polymer material can advantageously be an expanded polymer foam, fabric, or mesh.

Preferably, the non-porous polymer layer has a permeahbility of less than 1.00 microns.

The porous and non-porous polymer layers can advantageously be made from the same polymer or copolymer but have different physical structures. The optic portion and the porous polymer layer can be made from the same polymer or copolymer but have different physical properties or structures. Further, the optic portion, the porous and non-porous polymer layers can all be made from the same polymer or copolymer but have different physical properties or structures.

When the prosthesis of the present invention includes a lens and a skirt, there can be an interpenetration bond between the lens and the skirt, and the interpenetration bond between the lens and the skirt can be formed by injection molding of the prosthesis as one piece, polymer casting with solvent evaporation, or direct polymerization.

When there is a lens and a skirt with an interpenetration bond between the lens and the skirt, the interpenetration bond between the lens and the skirt can be either chemical or physical in nature.

The prosthesis preferably includes a lens and the porous polymer material preferably forms a skirt; the porous polymer material preferably has a closed pore barrier between the anterior and posterior aspects of the skirt to prevent the leakage of fluid and entrance of pathogens into the eye through the open pores before WO 95/20367 PCT/US94/01016 -8cellular infiltration/healing into the pores is complete.

In such a case, the closed pore barrier is preferably of the same polymer as the porous portion and is preferably made during the injection molding, polymerization process, or electrostatic deposition of the porous portion.

The non-porous layer is preferably a non-biodegradable polyether urethane, polyacrylate, polymethacrylate, polysiloxane, biopolymer, polyethylene, polyester (saturated) or a copolymer of these polymer families.

The porous polymer material preferably comprises a material from the group of polymer families consisting of polyether urethanes, polypropylene/polybutylenes, polytetrafluproethylenes, polyothoesters, polyesters (saturated), polyethylene terphthalates, polyacrylates, polyethylenes, polysiloxanes and silicone-polyurethane copolymers.

The tissue attachment site can be defined by two porous polymer material layers coherently attached to a central non-porous polymer material layer. In such a case, the two porous polymer material layers on either side of the central non-porous polymer material layer preferably have different average porosities both larger than microns.

BRIEF DESCRIPTION OF THE DRAWINGS: For a further understanding of the nature and objects of the present invention, reference should be made to the following detailed description, taken in conjunction with the accompanying drawings, in which like parts are given like reference numerals, and wherein: Figure 1 is a side, cutaway view of the eye; while Figure 2 is a side, cutaway detail of the eye.

Figure 3 and 3A are front and side, cross-sectional views, respectively, of a first, preferred, exemplary embodiment of the prostheses of the present invention.

Figures 4 and 4A are front and side, cross-section views, respectively, of a second, preferred, exemplary embodiment of the prostheses of the present invention.

WO 95/20367 PCT/US94/01016 -9- Figure 5 is a side, cutaway view of the eye with the first embodiment (Figures 3 and 3A) implanted; while Figure 6 is a side, cutaway view of the eye with the second embodiment (Figures 4 and 4A) implanted.

Figures 7-9 are schematic diagrams illustrating the layering of porous and non-porous layers of material used with the prostheses of the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EXEMPLARY EMBODIMENTS -GENERAL, OCULAR BACKGROUND- Referring to Figures 1 and 2, a cross-sectional view of the human eye Is shown, so 4-hat the loca 4. 4on anarrangement of the interior ocular element of the eye may be referred to.

As general background, the eye has a hemispherical shaped cornea 10, which extends laterally from the corneal epithelium 12 to the corneal endothelium 14. Extending laterally over the anterior surface of the corneal endothelium 14 is a hemispherical shaped membrane, known as Descement's membrane 16, which separates the body or stroma 17 of the cornea 10 from the corneal endothelium 14.

Surrounding the periphery of the cornea 10 is an annular portion called the limbus 18. The cornea 10 along with the limbus 18, are positioned in an opening in the sclera 20, with the tissues of the sclera interconnecting with the limbus 18.

Behind the posterior surface of the cornea is the posterior lens 22. The lens 22 is positioned in a pocket 23 between the iris 24 and the vitreous body 26 of the eye.

Between the iris 24 and the vitreous body 26 an annularly shaped portion known as the ciliary body 28 is found. The ciliary body 28 includes the ciliary muscle 101, ciliary prosthesis and zonular fibers 29 which interconnect with the circularly periphery of the lens capsule 122 so that the lens may change shape in response to ciliary body 28 contraction.

Also shown in Figures 1 and 2 are lateral rectus 102, WO 95/20367 PCT/US94/01016 retina 104, anterior chamber 106, fovea 107, choroid 108, dural sheath 109, optic nerve 113, bulbar conjunctiva 114, lamina cribrosa 115, ora serrata 117, medial rectus 118, Sphincter pupillae 121, lens capsule (or capsular bag) 122, lens epithelium 125, pigment layer 127, Bowman's membrane 128, ciliary processes 129, corneoscleral trabeculum 133, canal of Schlemm 134, and scleral spur 135.

In general, the prosthesis may be implanted in an annular void, which extends radially into the tissues of the eye generally between the anterior surface of the cornea 10 of the eye and the posterior surface of the lens capsule 122 of the eye. The prosthesis allows for the replacement of for example a diseased intraocular portion of the eye which is removed therefrom as discussed in the following.

The prosthesis includes a circular transparent ocular element which is elastomeric and preferably clear. The element may be made from any suitable material such as for example a polymer, with suitable types of polymer being a hydrophilic urethane, a strong hydrogel/hydrophilic urethane copolymer or interpenetrating network polymer, a strong hydrogel or a hydrophilic silicone, afluoropolymer, cellulose acetate butyrate or other like material that can be cast or formed.

Figures 7, 8, and 9 illustrate schematically examples of layering of the porous and non-porous layers. A prosthesis, designated respectively as 10A in Figure 7 and in Figure 8, includes a non-porous layer L2 forms an internal layer with porous polymer layers L1 and L3 positioned on both sides of the layer L2. In Figure 9, a prosthesis 10C having a porous polymer layer L3 abuts on one side a non-porous polymer layer L2. Layers L1, L2, and L3 can be made of the materials and in the manner described in the Summary of the invention.

Many prosthetic devices of the eye need to be anchored into the adjacent tissue to secure the prosthesis in place over time and prevent extrusion. Anchoring can be difficult WO 95/20367 PCT/US94/01016 -11since for best results the compliance of the anchoring portion of the device must be near that of the tissue. The compliance of metal is very different from tissue, so tissue tears away from metal under stress. The ocular prostheses of the present invention have porous polymer portions for ingrowth and attachment of the surrounding tissue to the prosthesis. Since compliance of the polymer material is similar to tissue, it does not easily tear away from the ingrown and attached tissue. The average size of the pores in the polymer material can range from 20 to microns. The configuration of the pores in the polymer materi.- may e different for different prosthetic applications. The configuration can be manipulated by the manufacturing techniques. The porous polymer material can be attached to the rest of the prosthesis or can comprise the entire prosthesis.

One configuration, similar to the one shown in Figure 9, but without layer L2, is that of a completely porous polymer material. This allows cellular ingrowth and attachment to concur completely throughout the porous polymer layer L3. Cell introduction can occur through all sides of the polymer material in layer L3 except where it is attached to the rest of the prosthesis. This material is useful for internal ocular prostheses where tissue anchoring is desired.

A second configuration, shown in Figures 7 and 8, is that of a porous polymer material (in layers L1 and L3) that has an internal non-porous layer L2 so that while ingrowth can occur from the anterior and posterior sides of the polymer there is no direct porous communication between the anterior and posterior sides. The non-porous layer L2 acts as a barrier against bacterial penetration or fluid leakage while the tissue is ingrowing and throughout the life of the prosthesis. This configuration is useful in scleral augmentation, conjunctival and corneal applications where complete security from an open globe situation is desired.

WO 95/20367 PCTUS94/01016 -12- A third configuration, shown in Figure 9, is that of a porous polymer material (in layer L3) with a non-porous side (layer L2). The pores may be of an average size or get progressively smaller as they approach the non-porous side L2. The non-porous side L2 may be surface grafted to change its hydrophilicity or be comprised of a more hydrophilic polymer than the porous portion L3 of the material. The material may be produced in a sheet or as a small diameter tube. In the tubular form it is a onepiece, ingrowth anchorable, tube with a non-porous inner surface and a porous outer surface, which can be used for fluid drainage applications such as glaucoma drains or lacrimal ducts.

The major manufacturing techniques used to make the porous polymer material are in the public domain such as electrostatic spinning and the Wong-Lightner technique.

The polymer used to produce the porous material can be a polyurethane, polypropylene-polybutylene copolymer, polytetrafluoroethylene, or an acrylate based polymer. The porous material may be grafted or coated to protect the polymer from oxidation or with proteins such as fibronectin, collagen or composites to promote and enhance cellular infiltration and attachment.

The material described above and shown in Figures 7, 8, and 9 (and including the material similar to that shown in Figure 9, but without layer L2), can be used as the flexible attachment means for the prostheses shown in Figures 3 and 4.

FIRST, KERATOPROSTHESIS EMBODIMENT (FIGS. 3, 3A Referring to Figures 3 and 3A, an embodiment of the prosthesis 30 suitable as a keratoprosthesis is shown. The prosthesis 30 includes an elastomeric element, which is generally hemispherically shaped, having a diameter generally eight millimeters.

The hemispherically shaped element 32 includes a convex anterior surface 34 having a radius of curvature WO 95/20367 PCT/US94/01016 -13generally for example 7.9 millimeters to insure good tear flow and lid closure and a concave posterior surface 36.

The radius of curvature for the concave posterior surface 36 controls how the power of the optic is determined and is dependent upon each patient's eye. Preoperatively the radius of curvature for the posterior surface may be determined for example, by performing an ultrasound scan and/or evaluating the patient's refraction and then making a clinical estimate of the proper power of the optic in order to determine proper refraction of the eye.

An annular skirt 38 extends radially from the peripheral edge 40 of the ocular element 32 and encircles the element 32. An annular porous portion 42 is included with the skirt 38 and surrounds element 32. The skirt 38 is circular and has a central opening 43, in which the optical element 32 is disposed.

The optical element 32 is permanently mated to the skirt 38 during the formation of the intraocular element A preferred embodiment for the skirt 38 has an annular portion 44, which is compressed by any suitable means and extends around the skirt 38. The annular portion 44 is located radially outward from the inner periphery 46 of the skirt 38 and radially inward from the outer periphery 48 of the skirt 38.

By compressing a portion of the skirt 38, a closed pore barrier 44 having a radial thickness of one millimeter may be formed which extends around the skirt 38 between its inner and outer peripheries 46, 48. Hence, suitable exemplary dimensions for the skirt 38 after compression would be for example a two millimeter radial thickness of annular open pore ingrowth space 50, which extends radially inward from the outer periphery 46 of the skirt 38; a one millimeter radial thickness annular closed pore barrier 44; and a one millimeter radial thickness open pore annular bonding portion 52, which extends radially outward from the inner periphery 46 of the skirt 38 and which surrounds WO 95/20367 PCTIUS94/01016 -14opening 43 for interpenetration and bonding of the lens element to the skirt 38.

A plurality of equidistantly spaced, spoke-like extensions or haptics 54 may extend radially outward from the periphery 48 of the skirt 38. The extensions 54 are likewise porous as the ingrowth space 50 and have a similar pore size of for example twenty-five to sixty microns.

Preferably, there are six, spoke-like extensions 54, which are spaced equidistant and radiate outward from the skirt 38.

SECOND, ACCOMMODATING, INTRAOCULAR LENS EMBODIMENT (FIGS. 4, 4A 6) Referring to Figures 4 and 4A, a second embodiment of the prosthesis 56 suitable as a replacement lens for the posterior lens of the eye is shown.

The prosthesis 56 includes an optical element 57 having at least one convex anterior 60 and a posterior 62 surface. The optical element 57 is elastomeric and of a suitable material such as the aforementioned hydrophilic, optical polyurethane so that it may be varied to focus on objects that are close or far away.

An annular skirt 64 extends radially from the peripheral edge 66 of the optical element 57 and encircles the element 57. The skirt 64 preferably has a diameter of for example thirteen millimeters and a thickness of for example 0.5 millimeters.

The embodiments and related methodologies described herein in detail for exemplary purposes are of course subject to many different variations in structure, design, methodology and application. Because many varying and different embodiments may be made within the scope of the inventive concept(s) herein taught, and because many modifications may be made in the embodiments herein detailed in accordance with the descriptive requirements of the law, it is to be understood that the details herein are to be interpreted as illustrative and not in a limiting sense.

CD/99187022.3 14a It will also be understood that the term "comprises" (or its grammatical variants) as used in this specification is equivalent to the term "includes" and should not be taken as excluding the presence of other elements or features.

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Claims

2. An ocular prosthesis for use as an implant within the eye socket region of a patient, within the patient's eye or on the outer surface of the patient's eye comprising: a) a prosthesis body having tissue adhesion means on a first outer surface of the prostheis body for forming a bond between the eye tissue and the prosthesis; b) wherein the tissue adhesion means comprises a portion formed of a porous polymer material having pores that enable connection to surrounding ocular tissue, wherein the pores of the polymer define a tissue attachment site; c) the prosthesis body having means for impeding fluid leakage past the implant at the tissue CD/99187022.3 16 attachment site; and d) wherein said means for impeding comprises a portion formed of a solid or closed-pore polymer material coextensive with the tissue attachment site so that a barrier is formed against generally transverse fluid and pathogen penetration from a second outer surface, which opposes said first outer surface, to the tissue attachment site.
3. An ocular prosthesis comprising: a) a prothesis body that includes a first outer surface of a porous polymer material having a pore size of about twenty to ninety (20-90) microns for 10 forming a tissue adhesion surface defining a tissue attachment site for attachment of surrounding ocular tissue; b) the body having a means for impeding fluid and pathogens .ooooi from leaking past the implant at the tissue attachment site; and c) wherein said means for impeding comprises a portion formed 15 of a solid or closed-pore polymer material coextensive with the tissue attachment site so that a barrier is formed against generally transverse fluid and pathogen S; penetration from a second outer surface, which opposes said first outer surface, to the tissue attachment site.
4. The prosthesis of claim 1, 2, or 3 wherein the porous polymer is of a material that will not unravel when cut. The prosthesis of claim 1, 2, or 3 wherein the porous polymer forms a porous layer and there is an adjacent non-porous layer so that a barrier is defined against bacterial penetration or fluid leakage.
6. The prosthesis of claim 5, wherein the non-porous layer is a non- porous polyurethane.
7. The prosthesis of any preceding claim, wherein the prosthesis is made from any of the following polymer families: polyether polyurethanes, polysiloxanes, polyacrylonitriles, polyesters (saturated), polyethylenes, CD/99187022.3 17 polyethylene terpthalates, polyacrylates, polyvinyl pyrrolidone, polymethacrylates, polytetrafluoroethylenes, or a copolymer of any of these.
8. The prosthesis of claim 1, 2 or 3 wherein: the porous polymer material comprises a material from the group consisting of polyurethane, polyethylene, polypropylene-polybutylene copolymer, polytetrafluoroethylene, and an acrylate based polymer.
9. The prosthesis of claim 1, 2 or 3, wherein the porous polymer material is an expanded polymer foam, fabric or mesh. The prosthesis of claim 1, 2 or 3, wherein the solid polymer layer is S. 10 substantially impermeable to fluids.
11. The ocular prosthesis of any preceding claim wherein the size of said pores is about 20-90 microns.
12. The prosthesis of any preceding claim wherein the prosthesis body (including the tissue attachment site with its porous and non-porous layers) is 15 made by injection or pressure molding, solvent casting, or electrostatic deposition ;of the polymer materials together.
13. The prosthesis of any preceding claim, wherein the non-porous polymer layer has a permeability of less than 1.00 microns.
14. The prosthesis of any preceding claim, wherein the porous and non-porous polymer layers are made from the same polymer or copolymer but have different physical structures. The prosthesis of any preceding claim, wherein there is at least an optic portion, and wherein the optic portion and the porous polymer layer are made from the same polymer or copolymer but have different physical properties or structures. CD/99187022.3 18
16. The prosthesis as claimed in any one of the preceding claims wherein there is a lens and a skirt with an interpenetration bond between the lens and the skirt, and wherein the interpenetration bond between the lens and the skirt is formed by injection molding of the prosthesis as one piece, polymer casting with solvent evaporation, or direct polymerization.
17. The prosthesis as claimed in any one of claims 1-14 wherein there is a lens and a skirt with an interpenetration bond between the lens and the skirt, and wherein the interpenetration bond between the lens and the skirt is either chemical or physical in nature.
18. The prosthesis as claimed in any one of claims 1-14, wherein there is a lens and the porous polymer material forms a skirt, and the porous polymer material has a closed pore barrier between the anterior and posterior aspects of said skirt to prevent the leakage of fluid and entrance of pathogens into the eye through the open pores before cellular infiltration/healing into the pores is 15 complete. o
19. The prosthesis of claim 18, wherein the closed pore barrier is of the same polymer as the porous portion and is made during the injection molding, polymerization process, or electrostatic deposition of the porous portion. S0*
20. The prosthesis of any one of claims 1-14, wherein the non-porous layer is a non-biodegradable polyether urethane, polyacrylate, polymethacrylate, polysiloxane, biopolymer, polyethylene, polyester (saturated) or a copolymer of these polymer families.
21. The prosthesis of any preceding claim, wherein the porous polymer material comprises a material from the group of polymer families consisting of polyether urethanes, polypropylene/polybutylenes, polytetrafluoroethylenes, polyothoesters, polyesters (saturated), polyethylene terphthalates, polyacrylates, polyethylenes, polysiloxanes and silicone-polyurethane copolymers.
22. The prosthesis of any preceding claim, wherein the tissue attachment site is CD/99187022.3 19 defined by two porous polymer material layers coherently attached to a central non-porous polymer material layer.
23. The prosthesis of claim 22, wherein the two porous polymer material layers on either side of the central non-porous polymer material layer have different average porosities both larger than 20 microns. Jean T. Jacob-Labarre By his Registered Patent Attorneys Freehills Patent Attorneys 7 July 1999 e go