Corneal mask formed of degradation resistant polymer and providing reduced corneal deposits

Abstract

Disclosed are masks configured to be implanted in a cornea of a patient. In one embodiment, the body of the mask has a light transmitting portion, a light blocking portion disposed about the light transmitting portion, and an outer periphery surrounding the light blocking portion. The mask is adapted to reside between two intracorneal layers of a cornea. In a preferred embodiment, the mask is formed from a material comprising a highly fluorinated polymeric material and an opacification agent and is resistant to degradation upon exposure to ultraviolet light. In another embodiment, the mask is formed from a material which comprises a polyanionic compound. In some embodiments, the mask includes one or more wound healing modulator compounds to aid in proper healing following implantation.

1 . A mask configured to be implanted in a cornea of a patient, the mask comprising: 
 a body formed from a polymeric material, the body having a light transmitting portion, a light blocking portion disposed about the light transmitting portion, an outer periphery surrounding the light blocking portion, an anterior surface, and a posterior surface, the anterior surface configured to reside adjacent a first intracorneal layer, the posterior surface configured to reside adjacent a second intracorneal layer, wherein the polymeric material includes one or more polyanionic compounds loaded into the polymeric material.    
     
     
         2 . The mask of  claim 1 , wherein the total weight of the one or more polyanionic compounds is about 5% by weight to about 20% by weight.  
     
     
         3 . The mask of  claim 1 , wherein the total weight of the one or more polyanionic compounds is about 12% by weight to about 17% by weight.  
     
     
         4 . The mask of  claim 1 , wherein the one or more polyanionic compounds comprise proteoglycans or glycosaminoglycans.  
     
     
         5 . The mask of  claim 1 , wherein the one or more polyanionic compounds includes at least one compound selected from the group consisting of dermatan sulfate, chondroitin sulfate, keratan sulfate, heparan sulfate, heparin, dextran sulfate, hyaluronic acid, pentosan polysulfate, xanthan, carrageenan, fibronectin, laminin, chondronectin, vitronectin, poly L-lysine salts, and alginate.  
     
     
         6 . The mask of  claim 1 , wherein the one or more polyanionic compounds comprises dextran sulfate.  
     
     
         7 . The mask of  claim 1 , wherein the polymeric material comprises a highly fluorinated polymeric material.  
     
     
         8 . The mask of  claim 7 , wherein the highly fluorinated polymeric material comprises polyvinylidene fluoride (PVDF).  
     
     
         9 . The mask of  claim 1 , wherein the material forming the light blocking portion of the body comprises an opacification agent selected from the group consisting of organic dyes organic pigments, inorganic dyes, and inorganic pigments.  
     
     
         10 . The mask of  claim 9 , wherein the opacification agent comprises carbon.  
     
     
         11 . The mask of  claim 10 , further comprising at least one wound healing modulator compound.  
     
     
         12 . The mask of  claim 11 , wherein at least a portion of the wound healing modulator compound is adsorbed to the carbon.  
     
     
         13 . The mask of  claim 11 , wherein the wound healing modulator compound is selected from the group consisting of antibiotics, antineoplastics, antimitotics, antimetabolics, anti-inflammatories, immunosupressants, and antifungals.  
     
     
         14 . The mask of  claim 13 , wherein the wound healing modulator compound is selected from the group consisting of fluorouracil, mitomycin C, paclitaxel, ibuprofen, naproxen, flurbiprofen, carprofen, suprofen, ketoprofen, and cyclosporins.  
     
     
         15 . The mask of  claim 1 , wherein the light transmitting portion comprises a substantially circular aperture that is sized to transmit a fraction of the light incident on the anterior surface.  
     
     
         16 . The mask of  claim 1 , wherein the body comprises a plurality of holes extending at least partially between the anterior surface and the posterior surface.  
     
     
         17 . The mask of  claim 1 , wherein the polymeric material includes a UV absorbing component.  
     
     
         18 . A mask configured to be implanted in a cornea of a patient, the mask comprising: 
 a body formed from a material comprising a highly fluorinated polymeric material, the body having a light transmitting portion, a light blocking portion disposed about the light transmitting portion, and outer periphery surrounding the light blocking portion, an anterior surface, and a posterior surface, the anterior surface configured to reside adjacent a first intracorneal layer, the posterior surface configured to reside adjacent a second intracorneal layer, wherein the material comprising a highly fluorinated polymeric material has loaded therein one or more polyanionic compounds.    
     
     
         19 . The mask of  claim 18 , wherein the one or more polyanionic compounds comprise proteoglycans or glycosaminoglycans.  
     
     
         20 . The mask of  claim 18 , wherein the one or more polyanionic compounds are selected from the group consisting of dermatan sulfate, chondroitin sulfate, keratan sulfate, heparan sulfate, heparin, dextran sulfate, hyaluronic acid, pentosan polysulfate, xanthan, carrageenan, fibronectin, laminin, chondronectin, vitronectin, poly L-lysine salts, and alginate.  
     
     
         21 . The mask of  claim 18 , wherein the one or more polyanionic compounds comprises dextran sulfate.  
     
     
         22 . The mask of  claim 18 , wherein the total weight of the one or more polyanionic compounds is about 10% by weight to about 20% by weight.  
     
     
         23 . The mask of  claim 18 , wherein the highly fluorinated polymeric material comprises PVDF.  
     
     
         24 . The mask of  claim 18 , wherein the material forming the light blocking portion of the body comprises an opacification agent selected from the group consisting of organic dyes organic pigments, inorganic dyes, and inorganic pigments.  
     
     
         25 . The mask of  claim 24 , wherein the opacification agent is carbon.  
     
     
         26 . The mask of  claim 25 , further comprising at least one wound healing modulator compound.  
     
     
         27 . The mask of  claim 26 , wherein at least a portion of the wound healing modulator compound is adsorbed to the carbon.  
     
     
         28 . The mask of  claim 26 , wherein the wound healing modulator compound is selected from the group consisting of antibiotics, antineoplastics, antimitotics, antimetabolics, anti-inflammatories, immunosupressants, and antifungals.  
     
     
         29 . The mask of  claim 28 , wherein the wound healing modulator compound is selected from the group consisting of fluorouracil, mitomycin C, paclitaxel, ibuprofen, naproxen, flurbiprofen, carprofen, suprofen, ketoprofen, and cyclosporins.  
     
     
         30 . The mask of  claim 18 , wherein the light transmitting portion comprises a substantially circular aperture that is sized to transmit a fraction of the light incident on the anterior surface.  
     
     
         31 . The mask of  claim 18 , wherein the material further comprises a second polymeric material.  
     
     
         32 . The mask of  claim 31 , wherein the second polymeric material includes a UV absorbing component.  
     
     
         33 . A mask comprising: 
 an aperture having a major axis of about 2.2 mm or less; and    an annular body extending between the aperture and an outer periphery of the mask, the annular body having an anterior surface and a posterior surface, the annular body being formed of a material comprising:    a highly fluorinated polymeric material;    an opacification agent, the opacification agent being present in sufficient quantity to prevent at least a substantial portion of light incident on the anterior surface from being transmitted from the anterior surface to the posterior surface; and    one or more polyanionic compounds and/or wound healing modulator compounds.    
     
     
         34 . The mask of  claim 33 , wherein the total weight of the one or more polyanionic compounds is about 5% by weight to about 20% by weight.  
     
     
         35 . The mask of  claim 33 , wherein the total weight of the one or more polyanionic compounds is about 12% by weight to about 17% by weight.  
     
     
         36 . The mask of  claim 33 , wherein the one or more polyanionic compounds comprise proteoglycans or glycosaminoglycans.  
     
     
         37 . The mask of  claim 33 , wherein the one or more polyanionic compounds are selected from the group consisting of dermatan sulfate, chondroitin sulfate, keratan sulfate, heparan sulfate, heparin, dextran sulfate, hyaluronic acid, pentosan polysulfate, xanthan, carrageenan, fibronectin, laminin, chondronectin, vitronectin, poly L-lysine salts, and alginate.  
     
     
         38 . The mask of  claim 33 , wherein the one or more polyanionic compounds comprises dextran sulfate.  
     
     
         39 . The mask of  claim 33 , wherein the highly fluorinated polymeric material comprises PVDF.  
     
     
         40 . The mask of  claim 33 , wherein the opacification agent is selected from the group consisting of organic dyes organic pigments, inorganic dyes, and inorganic pigments.  
     
     
         41 . The mask of  claim 40 , wherein the opacification agent is carbon.  
     
     
         42 . The mask of  claim 41 , further comprising at least one wound healing modulator compound.  
     
     
         43 . The mask of  claim 42 , wherein at least a portion of the wound healing modulator compound is adsorbed to the carbon.  
     
     
         44 . The mask of  claim 42 , wherein the wound healing modulator compound is selected from the group consisting of antibiotics, antineoplastics, antimitotics, antimetabolics, anti-inflammatories, immunosupressants, and antifungals.  
     
     
         45 . The mask of  claim 44 , wherein the wound healing modulator compound is selected from the group consisting of fluorouracil, mitomycin C, paclitaxel, ibuprofen, naproxen, flurbiprofen, carprofen, suprofen, ketoprofen, and cyclosporins.  
     
     
         46 . The, mask of  claim 33 , wherein the anterior surface is configured to reside adjacent a first intracorneal layer of a cornea, and the posterior surface is configured to reside adjacent a second intracorneal layer.  
     
     
         47 . The mask of  claim 46 , wherein the mask does not substantially alter the curvature of a cornea following application of the mask to a cornea.  
     
     
         48 . The mask of  claim 33 , wherein the annular body has a substantially constant thickness between the anterior and posterior surfaces.  
     
     
         49 . The mask of  claim 33 , wherein the annular body has a thickness between the anterior and posterior surfaces of about 20 microns or less.  
     
     
         50 . The mask of  claim 33 , wherein the annular body has a thickness between the anterior and posterior surfaces of about 8 microns.  
     
     
         51 . A mask configured to be implanted in a cornea of a patient, the mask comprising: 
 a body formed from a polymeric material, the body having a light transmitting portion, a light blocking portion disposed about the light transmitting portion, an outer periphery surrounding the light blocking portion, an anterior surface configured to reside adjacent a first intracorneal layer, a posterior surface configured to reside adjacent a second intracorneal layer, and at least one wound healing modulator loaded in the polymeric material and/or bound to at least one of the anterior surface and the posterior surface.    
     
     
         52 . The mask of  claim 51 , wherein at least the light blocking portion comprises carbon.  
     
     
         53 . The mask of  claim 52 , wherein at least a portion of the wound healing modulator compound is adsorbed to the carbon.  
     
     
         54 . The mask of  claim 51 , wherein the wound healing modulator compound is selected from the group consisting of antibiotics, antineoplastics, antimitotics, antimetabolics, anti-inflammatories, immunosupressants, and antifungals.  
     
     
         55 . The mask of  claim 54 , wherein the wound healing modulator compound is selected from the group consisting of fluorouracil, mitomycin C, paclitaxel, ibuprofen, naproxen, flurbiprofen, carprofen, suprofen, ketoprofen, and cyclosporins.  
     
     
         56 . The mask of  claim 51 , wherein the polymeric material is UV-resistant and/or includes a UV absorbing component.  
     
     
         57 . The mask of  claim 56 , wherein the polymeric material comprises a highly fluorinated polymeric material.  
     
     
         58 . The mask of  claim 57 , wherein the highly fluorinated polymeric material comprises polyvinylidene fluoride (PVDF).  
     
     
         59 . The mask of  claim 51 , wherein the light transmitting portion comprises a substantially circular aperture that is sized to transmit a fraction of the light incident on the anterior surface.  
     
     
         60 . The mask of  claim 51 , wherein the body comprises a plurality of holes extending at least partially between the anterior surface and the posterior surface.  
     
     
         61 . The mask of  claim 51 , wherein polymeric material comprises one or more polyanionic compounds.  
     
     
         62 . The mask of  claim 61 , wherein the total weight of the one or more polyanionic compounds is about 5% by weight to about 20% by weight.  
     
     
         63 . The mask of  claim 61 , wherein the one or more polyanionic compounds comprise proteoglycans or glycosaminoglycans.  
     
     
         64 . The mask of  claim 61 , wherein the one or more polyanionic compounds includes at least one compound selected from the group consisting of dermatan sulfate, chondroitin sulfate, keratan sulfate, heparan sulfate, heparin, dextran sulfate, hyaluronic acid, pentosan polysulfate, xanthan, carrageenan, fibronectin, laminin, chondronectin, vitronectin, poly L-lysine salts, and alginate.  
     
     
         65 . The mask of  claim 61 , wherein the one or more polyanionic compounds comprises dextran sulfate.