Pre-fabricated corneal tissue lens and method of corneal overlay to correct vision

Abstract

This invention relates to a contact lens made of donor corneal tissue, to a method of preparing that lens, and to a technique of placing the lens on the eye. The lens is made of donor corneal tissue that is acellularized by removing native epithelium and keratocytes. These cells are replaced with human epithelium and keratocytes to form a lens that has a structural anatomy similar to human cornea. The ocular lens is used to correct conditions such as astigmatism, myopia, aphakia, and presbyopia.

I claim as my invention:  
     
         1 . An ocular lens device comprising: 
 a lens core comprising donor corneal tissue having a generally convex anterior surface and a posterior surface, and having replaced keratocytes in said lens core or replaced epithelial cells covering at least a portion of said anterior surface.    
     
     
         2 . The ocular lens device of  claim 1  wherein said posterior surface is generally concave.  
     
     
         3 . The ocular lens device of  claim 1  wherein said lens core comprises acellular corneal tissue.  
     
     
         4 . The ocular lens device of  claim 1  wherein said lens core consists essentially of acellular corneal tissue.  
     
     
         5 . The ocular lens device of  claim 1  wherein said posterior surface is concave.  
     
     
         6 . The ocular lens device of  claim 1  wherein said posterior surface has been subjected to a shaping step.  
     
     
         7 . The ocular lens device of  claim 6  wherein said posterior surface is shaped by an ablative laser.  
     
     
         8 . The ocular lens device of  claim 1  wherein said ocular lens has a clarity at least 85% of that of human corneal tissue of a corresponding thickness.  
     
     
         9 . The ocular lens device of  claim 8  wherein said ocular lens has a clarity between about 75% and about 100% of that of human corneal tissue of a corresponding thickness.  
     
     
         10 . The ocular lens device of  claim 9  wherein said lens core has a clarity at least 90% of that of human corneal tissue of a corresponding thickness.  
     
     
         11 . The ocular lens device of  claim 1  wherein said lens core comprises donor corneal tissue.  
     
     
         12 . The ocular lens device of  claim 11  wherein said lens core comprises human corneal tissue.  
     
     
         13 . The ocular lens device of  claim 11  wherein said lens core comprises allogeneic corneal tissue.  
     
     
         14 . The ocular lens device of  claim 11  wherein said lens core comprises xenogenic corneal tissue.  
     
     
         15 . The ocular lens device of  claim 14  wherein said xenogenic lens core comprises corneal tissue selected from the group consisting of rabbit, bovine, porcine, and guinea pig corneal tissue.  
     
     
         16 . The ocular lens device of  claim 11  wherein said lens core comprises transgenic corneal tissue.  
     
     
         17 . The ocular lens device of  claim 11  wherein said donor corneal tissue has a structural surface and said lens core anterior surface is the structural surface of the donor corneal tissue.  
     
     
         18 . The ocular lens device of  claim 1  wherein said size and configuration is selected to be corrective for at least one selected from the group consisting of astigmatism, myopia, aphakia, and presbyopia.  
     
     
         19 . The ocular lens device of  claim 18  wherein said size and configuration is selected to be corrective for myopia and said device has a generally circular, flat lens core center region.  
     
     
         20 . The ocular lens device of  claim 18  wherein said size and configuration is selected to be corrective for aphakia and said device has a generally flattened perimeter.  
     
     
         21 . The ocular lens device of  claim 18  wherein said size and configuration is selected to be corrective for presbyopia and has generally circular lens core central region without correction.  
     
     
         22 . The ocular lens device of  claim 18  wherein said size and configuration is selected to be bifocal.  
     
     
         23 . The ocular lens device of  claim 22  wherein said lens core further comprises an opaque annular ring having a central open region and peripheral diameter.  
     
     
         24 . The ocular lens device of  claim 23  wherein said ring is formed by tatooing or placement of opaque material on said posterior surface.  
     
     
         25 . The ocular lens device of  claim 23  wherein said central open region has a diameter less than about 1.5 mm.  
     
     
         26 . The ocular lens device of  claim 25  wherein said central open region has a diameter between about 0.5 mm and about 1.5 mm.  
     
     
         27 . The ocular lens device of  claim 25  wherein said central open region has a diameter between about 0.75 mm and about 1.25 mm.  
     
     
         28 . The ocular lens device of  claim 24  wherein said ring comprises a Dacron mesh.  
     
     
         29 . The ocular lens device of  claim 23  wherein said ring peripheral diameter is between 3-5 mm.  
     
     
         30 . The ocular lens device of  claim 29  wherein said ring peripheral diameter is selected to be less than the pupillary diameter of a selected recipient eye in low light.  
     
     
         31 . The ocular lens device of  claim 1  wherein said lens core further contains a therapeutic agent, immunosuppresive agent, or growth factors.  
     
     
         32 . The ocular lens device of  claim 1  wherein said lens core has not been frozen, lyophilized, or chemically treated by a fixative.  
     
     
         33 . The ocular lens device of  claim 11  wherein said lens core is comprised of corneal tissue grown in vitro.  
     
     
         34 . The ocular lens device of  claim 1  wherein said epithelial cells and keratocytes comprise human corneal cells.  
     
     
         35 . The ocular lens device of  claim 34  wherein said epithelial cells and keratocytes comprise neonatal, fetal, or tissue bank corneal cells.  
     
     
         36 . The ocular lens device of  claim 1  wherein said lens core has a thickness and said thickness is less than 300 μm.  
     
     
         37 . The ocular lens device of  claim 36  wherein said lens core thickness is between 5- 100 μm.    
     
     
         38 . The ocular lens device of  claim 1  wherein said lens core has replaced keratocytes.  
     
     
         39 . The ocular lens device of  claim 1  wherein said lens core has replaced epithelial cells covering at least a portion of said anterior surface.  
     
     
         40 . A method for correcting the vision of a human eye having a cornea with an anterior surface, comprising the steps of: 
 a) preparing the anterior surface of the cornea; and    b) introducing the ocular device of any of claims  1 - 39  upon said prepared anterior surface.    
     
     
         41 . The method of  claim 40  wherein said preparing step comprises removing a substantial portion of any epithelial cells present upon the anterior surface.  
     
     
         42 . A method for the preparation of an ocular lens device comprising: 
 a) harvesting a lens core comprising donor corneal tissue and having a generally convex anterior surface and a generally concave posterior surface; and    b) having replaced epithelium covering at least a portion of said generally convex anterior surface; and    c) having replaced keratocytes repopulating said lens core, comprising the steps of: 
 i) devitalizing said lens core; and  
 ii) revitalizing said lens core.  
   
     
     
         43 . The method of  claim 42  further comprising the step of shaping said posterior surface.  
     
     
         44 . The method of  claim 43  wherein said posterior surface is shaped by an ablative laser.  
     
     
         45 . The method  claim 43  wherein said posterior surface is shaped by an excimer laser or other suitable shaping lasers.  
     
     
         46 . The method of  claim 43  wherein said posterior surface is shaped by water jet cutting.  
     
     
         47 . The method of  claim 43  wherein said posterior surface is shaped to correct at least one selected from the group consisting of myopia, aphakia, presbyopia, and astigmatism.  
     
     
         48 . The method of  claim 42  further comprising the step of harvesting said lens core.  
     
     
         49 . The method of  claim 48  wherein said lens core is harvested from human, rabbit, bovine, porcine, or guinea pig corneal tissue.  
     
     
         50 . The method of  claim 42  wherein said revitalization step includes cells cultured from human corneal tissue.  
     
     
         51 . The method of  claim 50  wherein said cells are cultured from neonatal tissue, fetal tissue, or tissue bank tissue.  
     
     
         52 . The method of  claim 43  further comprising the step of sterilizing said lens core after said shaping step.  
     
     
         53 . The method of  claim 52  wherein said sterilization step includes the step of contacting said lens core with glycerol.  
     
     
         54 . The method of  claim 52  wherein said sterilization step includes the step of contacting said lens core with ethylene oxide gas.  
     
     
         55 . The method of  claim 42  wherein said devitalization step comprises removing epithelium from said anterior surface and keratocytes from said lens core.  
     
     
         56 . The method of  claim 42  wherein said revitalization step comprises adding epithelium to at least a portion of said anterior surface and keratocytes to said lens core.  
     
     
         57 . The method of  claim 42  wherein said revitalization step includes the step of placing said lens core on a polyelectrolyte gel.  
     
     
         58 . The method of  claim 42  wherein the corneal tissue matrix of said lens core is not altered.