Method of producing an epithelial flap (II)

Abstract

This relates to a lens made of donor corneal tissue suitable for use as a contact lens or an implanted lens, 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 optionally are replaced with human epithelium and keratocytes to form a lens that has a structural anatomy similar to human cornea. The ocular lens may be used to correct conditions such as astigmatism, myopia, aphakia, and presbyopia.

1 . A method for acting on an eye having an anterior corneal surface and an epithelial tissue layer, the method comprising: 
 a.) lifting from the anterior corneal surface, a portion of the epithelial tissue layer resulting in a lifted continuous epithelial layer separated from a corneal stromal margin and having a portion of that lifted continuous epithelial layer connected to the corneal surface,    b.) performing an action on the corneal stromal margin from which a portion of the epithelial layer has been separated, and    c.) returning the lifted continuous epithelial layer to the eye adjacent to the corneal stromal margin from which a portion of the epithelial layer has been separated.    
     
     
         2 . The method of  claim 1  wherein the step of performing an action on the corneal stromal margin comprises placing an ocular device onto the corneal stromal margin from which a portion of the epithelial layer has been separated.  
     
     
         3 . The method of  claim 1  wherein the step of performing an action on the corneal stromal margin comprises placing a corrective ocular device onto the corneal stromal margin from which a portion of the epithelial layer has been separated.  
     
     
         4 . The method of  claim 1  wherein the step of performing an action on the corneal stromal margin comprises performing a laser corrective procedure on the corneal stromal margin from which a portion of the epithelial layer has been separated.  
     
     
         5 . The method of  claim 1  wherein said lifting step comprises employing vacuum to lift the epithelial layer from the anterior surface.  
     
     
         6 . A method for acting on an eye having an anterior corneal surface and an epithelial tissue layer, the method comprising: 
 a.) lifting from the anterior corneal surface with a device, a portion of the epithelial layer resulting in a living, lifted continuous epithelial layer separated from a corneal stromal margin having a portion connected to the corneal surface, and    b.) removing the device and leaving the separated epithelial layer connected to the corneal surface.    
     
     
         7 . The method of  claim 6  further comprising the step of performing an action on the corneal stromal margin from which a portion of the epithelial layer has been separated.  
     
     
         8 . The method of  claim 6  further comprising the step of returning the lifted continuous epithelial layer to the eye adjacent to the corneal stromal margin from which a portion of the epithelial layer has been separated.  
     
     
         9 . The method of  claim 7  wherein the step of performing an action on the corneal stromal margin comprises placing an ocular device onto the corneal stromal margin from which a portion of the epithelial layer has been separated.  
     
     
         10 . The method of  claim 7  wherein the step of performing an action on the corneal stromal margin comprises placing a corrective ocular device onto the corneal stromal margin from which a portion of the epithelial layer has been separated.  
     
     
         11 . The method of  claim 7  wherein the step of performing an action on the corneal stromal margin comprises performing a laser corrective procedure on the corneal stromal margin from which a portion of the epithelial layer has been separated.  
     
     
         12 . The method of  claim 7  wherein said lifting step comprises employing vacuum to lift the continuous epithelial layer separated from the corneal stromal margin.  
     
     
         13 . The method of  claim 1  wherein the continuous epithelial layer separated from a corneal stromal margin contains substantially no corneal tissue.  
     
     
         14 . A method for acting on an eye having a cornea and epithelial tissue attached thereto, the method comprising: 
 a) separating from the cornea a tissue layer comprising epithelial tissue substantially free of other corneal tissue resulting in an exposed anterior corneal surface and a separated continuous epithelial tissue layer separated from the exposed anterior corneal surface, the separated layer having a portion connected to the eye,    b) placing a corrective ocular device entirely onto the exposed anterior corneal surface, and    c) placing at least a portion of the separated layer onto the corrective ocular device.    
     
     
         15 . The method of  claim 14  wherein the separating step comprises employing vacuum to lift the tissue layer comprising epithelial tissue from the cornea.  
     
     
         16 . The method of  claim 14  wherein the corrective ocular device further contains at least one of a therapeutic agent, an immunosuppressive agent, and one or more growth factors.  
     
     
         17 . The method of  claim 14  wherein the corrective ocular device comprises a lens.  
     
     
         18 . The method of  claim 14  wherein the separating step separates from the cornea a tissue layer consisting essentially of epithelial tissue.  
     
     
         19 . The method of  claim 14  wherein the separating step separates from the cornea a tissue layer of substantially only epithelial tissue.  
     
     
         20 . The method of  claim 14  wherein the separating step comprises separating the tissue layer from Bowman's Membrane.  
     
     
         21 . A method for acting on an eye having a cornea and epithelial tissue attached thereto, the method comprising: 
 a) separating from the cornea with a device, a tissue layer comprising epithelial tissue substantially free of other corneal tissue to produce an exposed anterior corneal surface, and a lifted, living, continuous epithelial tissue layer separated from the exposed anterior corneal surface and having a portion connected to the eye,    b) removing the device from the eye leaving the lifted epithelial tissue layer having a portion connected to the eye,    c.) introducing a corrective ocular device entirely onto the exposed anterior corneal surface, and    c) placing at least a portion of the lifted layer onto the corrective ocular device.    
     
     
         22 . The method of  claim 21  wherein the using step comprises employing a vacuum to lift the tissue layer comprising epithelial tissue from the cornea.  
     
     
         23 . The method of  claim 21  wherein the corrective ocular device further contains at least one of a therapeutic agent, an immunosuppressive agent, and one or more growth factors.  
     
     
         24 . The method of  claim 21  wherein the corrective ocular device comprises a lens.  
     
     
         25 . The method of  claim 21  wherein the separating step separates from the cornea a tissue layer consisting essentially of epithelial tissue.  
     
     
         26 . The method of  claim 21  wherein the separating step separates from the cornea a tissue layer of substantially only epithelial tissue.  
     
     
         27 . The method of  claim 21  wherein the separating step comprises separating the tissue layer from Bowman's Membrane.  
     
     
         28 . A method for acting on an eye having a cornea and epithelial tissue attached thereto, wherein a tissue layer comprising epithelial tissue substantially free of other corneal tissue has been separated from the cornea, resulting in an exposed anterior corneal surface and a separated continuous epithelial tissue layer separated from the cornea and the separated layer having a portion connected to the eye, the method comprising: 
 a) placing a corrective ocular device entirely onto the exposed anterior corneal surface, and    b) placing at least a portion of the separated layer onto the corrective ocular device.    
     
     
         29 . The method of  claim 28  wherein the corrective ocular device further contains at least one of a therapeutic agent, an immunosuppressive agent, and one or more growth factors.  
     
     
         30 . The method of  claim 28  wherein the corrective ocular device is a lens.  
     
     
         31 . The method of  claim 28  wherein the separated layer consists essentially of epithelial tissue.  
     
     
         32 . The method of  claim 28  wherein the separated layer is substantially only epithelial tissue.  
     
     
         33 . The method of  claim 28  wherein the separated layer is free of Bowman's Membrane.  
     
     
         34 . A method for acting on an eye having a cornea and epithelial tissue attached thereto, wherein a tissue layer comprising epithelial tissue substantially free of other corneal tissue has been separated from the cornea, resulting in an exposed anterior corneal surface and a separated continuous epithelial tissue layer separated from the cornea and the separated layer having a portion connected to the eye, and a corrective ocular device has been placed entirely onto the exposed anterior corneal surface, the method comprising the step of: 
 placing at least a portion of the separated layer onto the corrective ocular device.    
     
     
         35 . The method of  claim 34  wherein the corrective ocular device further contains at least one of a therapeutic agent, an immunosuppressive agent, and one or more growth factors.  
     
     
         36 . The method of  claim 34  wherein the corrective ocular device comprises a lens.  
     
     
         37 . The method of  claim 34  wherein the separated layer consists essentially of epithelial tissue.  
     
     
         38 . The method of  claim 34  wherein the separated layer is substantially only epithelial tissue.  
     
     
         39 . The method of  claim 34  wherein the separated layer is free of Bowman's Membrane.  
     
     
         40 . A method for acting on an eye having a cornea and epithelial tissue attached thereto, the method comprising the step of separating from the cornea a tissue layer comprising epithelial tissue substantially free of other corneal tissue, the separating step producing an exposed anterior corneal surface and a separated continuous epithelial tissue layer separated from the exposed anterior corneal surface, the separated layer having a portion connected to the eye.  
     
     
         41 . The method of  claim 40  further comprising the step of performing an action on the corneal stromal margin from which the separated continuous epithelial tissue layer has been separated.  
     
     
         42 . The method of  claim 41  wherein the step of performing an action on the corneal stromal margin comprises placing an ocular device onto the corneal stromal margin from which the separated continuous epithelial tissue layer has been separated.  
     
     
         43 . The method of  claim 41  wherein the step of performing an action on the corneal stromal margin comprises placing a corrective ocular device onto the corneal stromal margin from which the separated continuous epithelial tissue layer has been separated.  
     
     
         44 . The method of  claim 41  wherein the step of performing an action on the corneal stromal margin comprises performing a laser corrective procedure on the corneal stromal margin from which the separated continuous epithelial tissue layer has been separated.  
     
     
         45 . The method of  claim 41  further comprising the step of returning the separated continuous epithelial tissue layer to the eye adjacent to the corneal stromal margin from which a portion of the epithelial layer has been separated.  
     
     
         46 . The method of  claim 42  further comprising the step of returning the separated continuous epithelial tissue layer to the eye adjacent to the corneal stromal margin from which a portion of the epithelial layer has been separated.  
     
     
         47 . The method of  claim 43  further comprising the step of returning the separated continuous epithelial tissue layer to the eye adjacent to the corneal stromal margin from which a portion of the epithelial layer has been separated.  
     
     
         48 . The method of  claim 44  further comprising the step of returning the separated continuous epithelial tissue layer to the eye adjacent to the corneal stromal margin from which a portion of the epithelial layer has been separated.  
     
     
         49 . The method of  claim 40  wherein the separating step comprises employing vacuum to lift the tissue layer comprising epithelial tissue from the cornea.  
     
     
         50 . The method of  claim 43  wherein the corrective ocular device further contains at least one of a therapeutic agent, an immunosuppressive agent, and one or more growth factors.  
     
     
         51 . The method of  claim 43  wherein the corrective ocular device comprises a lens.  
     
     
         52 . The method of  claim 40  wherein the separating step separates from the cornea a tissue layer consisting essentially of epithelial tissue.  
     
     
         53 . The method of  claim 40  wherein the separating step separates from the cornea a tissue layer of substantially only epithelial tissue.  
     
     
         54 . The method of  claim 41  wherein the separating step comprises separating the tissue layer from Bowman's Membrane.  
     
     
         55 . A method for acting on an eye having a cornea and epithelial tissue attached thereto, wherein a tissue layer comprising epithelial tissue substantially free of other corneal tissue has been separated from the cornea, resulting in an exposed anterior corneal surface and a separated continuous epithelial tissue layer separated from the cornea and the separated layer having a portion connected to the eye, the method comprising the step of performing a vision corrective action upon the exposed anterior corneal surface.  
     
     
         56 . The method of  claim 55  wherein the step of performing an action on the corneal stromal margin comprises placing an ocular device onto the corneal stromal margin from which the separated continuous epithelial tissue layer has been separated.  
     
     
         57 . The method of  claim 55  wherein the step of performing an action on the corneal stromal margin comprises placing a corrective ocular device onto the corneal stromal margin from which the separated continuous epithelial tissue layer has been separated.  
     
     
         58 . The method of  claim 55  wherein the step of performing an action on the corneal stromal margin comprises performing a laser corrective procedure on the corneal stromal margin from which the separated continuous epithelial tissue layer has been separated.  
     
     
         59 . The method of  claim 55  further comprising the step of returning the separated continuous epithelial tissue layer to the eye adjacent to the corneal stromal margin from which a portion of the epithelial layer has been separated.  
     
     
         60 . The method of  claim 56  further comprising the step of returning the separated continuous epithelial tissue layer to the eye adjacent to the corneal stromal margin from which a portion of the epithelial layer has been separated.  
     
     
         61 . The method of  claim 57  further comprising the step of returning the separated continuous epithelial tissue layer to the eye adjacent to the corneal stromal margin from which a portion of the epithelial layer has been separated.  
     
     
         62 . The method of  claim 58  further comprising the step of returning the separated continuous epithelial tissue layer to the eye adjacent to the corneal stromal margin from which a portion of the epithelial layer has been separated.  
     
     
         63 . The method of  claim 57  wherein the corrective ocular device further contains at least one of a therapeutic agent, an immunosuppressive agent, and one or more growth factors.  
     
     
         64 . The method of  claim 57  wherein the corrective ocular device comprises a lens.  
     
     
         65 . The method of  claim 55  wherein the separated continuous epithelial tissue layer consists essentially of epithelial tissue.  
     
     
         66 . The method of  claim 55  wherein the separated continuous epithelial tissue layer is substantially only epithelial tissue.  
     
     
         67 . The method of  claim 55  wherein the separated continuous epithelial tissue layer is free of Bowman's Membrane.