Method and device for treating and managing diseased ocular tissue

Abstract

A method of treating and managing diseased ocular tissue in the bulbar conjunctiva comprises providing a device comprising a plurality of microneedles arranged on a substrate contacting the device with a diseased ocular tissue region formed in the bulbar conjunctival stroma to form a plurality of micro-injury sites therein. A device comprises a contact lens substrate comprising a substantially elliptical corneal portion and a limbus portion located radially about the corneal portion. A scleral portion is located radially about the substrate. The device is at least partially degradable and comprises a therapeutic compound. At least a portion of the scleral portion is configured to overlay, and deliver the therapeutic compound to, a diseased ocular tissue located adjacent to the cornea of a patient.

What is claimed is: 
     
         1 . A method of treating and managing diseased ocular tissue in the bulbar conjunctiva comprising:
 providing a device comprising a plurality of microneedles arranged on a substrate; and   contacting the device with a diseased ocular tissue region formed in the bulbar conjunctival stroma to form a plurality of micro-injury sites within the diseased bulbar conjunctival stroma, and cause release of growth factors and formation of new collagen fibrils.   
     
     
         2 . The method of  claim 1 , comprising contacting the microneedles with the vasculature located in the bulbar conjunctival stroma to initiate bleeding and release of growth factors. 
     
     
         3 . The method of  claim 1 , comprising contacting the microneedles in bulbar conjunctival stroma to cause formation of aligned collagen and elastin fibrils. 
     
     
         4 . The method of  claim 1 , comprising penetrating the microneedles into the bulbar conjunctival stroma without penetrating through the scleral tissue located below the bulbar conjunctiva. 
     
     
         5 . The method of  claim 1 , wherein the diseased ocular tissue region comprises a pinguecula or pterygium. 
     
     
         6 . The method of  claim 1 , further comprising the step of determining the dimensions of the diseased ocular tissue region and determining the arrangement and dimensions of the microneedles based on the diseased tissue dimensions. 
     
     
         7 . The method of  claim 1 , wherein the device microneedles are arranged and dimensioned to penetrate a curved path on the diseased tissue around the cornea. 
     
     
         8 . The method of  claim 1 , wherein the microneedles are degradable and comprise a therapeutic compound. 
     
     
         9 . A device for treating and managing diseased ocular tissue in the bulbar conjunctiva, comprising:
 a substrate; and   a plurality of microneedles positioned on a substrate;   
       wherein the microneedles are arranged and dimensioned such that when the device is brought into contact with the diseased tissue, the microneedles penetrate a diseased ocular tissue region formed in the bulbar conjunctival stroma, to produce a plurality of micro-injury sites within the diseased bulbar conjunctival stroma region, and cause release of growth factors and formation of new collagen fibrils. 
     
     
         10 . The device of  claim 9 , wherein the shape of the substrate and arrangement of the microneedles provides coverage of the surface of diseased tissue penetrated without contacting the cornea. 
     
     
         11 . The device of  claim 9 , wherein the microneedles are arranged and dimensioned to interact with the vasculature located in the bulbar conjunctival stroma to initiate bleeding and release of growth factors. 
     
     
         12 . The device of  claim 9 , wherein the substrate is curved to substantially fit at least one radius of curvature of the diseased tissue. 
     
     
         13 . The device of  claim 9 , wherein the microneedles are degradable and comprising a therapeutic compound. 
     
     
         14 . A device for treating and managing diseased ocular tissue in the bulbar conjunctiva, comprising:
 a contact lens substrate comprising:   a substantially elliptical corneal portion;   a limbus portion located radially about the corneal portion; and   a scleral portion located radially about the substrate;   
       wherein the device is at least partially degradable and comprises a therapeutic compound, and wherein at least a portion of the scleral portion is configured to overlay, and deliver the therapeutic compound to, a diseased ocular tissue located adjacent to the cornea of a patient. 
     
     
         15 . The device of  claim 14 , comprising plurality of microneedles positioned on the scleral portion of the device, wherein the microneedles are arranged and dimensioned such that when the device is brought into contact with the diseased tissue, the microneedles penetrate a diseased ocular tissue region formed in the bulbar conjunctival stroma, to produce a plurality of micro-injury sites within the diseased bulbar conjunctival stroma region, and cause release of growth factors and formation of new collagen fibrils. 
     
     
         16 . The device of  claim 14 , wherein the scleral portion is at least partially degradable. 
     
     
         17 . The device of  claim 14 , wherein the scleral portion comprises at least one lateral extension portion configured to overlay a Pinguecula located on the nasal or temporal bulbar conjunctiva. 
     
     
         18 . The device of  claim 14 , wherein the scleral portion comprises at least one vertical extension portion configured to contact the interior eyelid wall. 
     
     
         19 . The device of  claim 14 , wherein the substrate comprises an optical material and is configured to correct a patient's visual acuity. 
     
     
         20 . The device of  claim 14 , wherein the device has a top side opposite an underside, and at least one degradable layer of a therapeutic compound on the top side or underside of the device. 
     
     
         21 . The device of  claim 14 , wherein the substrate comprises an open central pupil portion, the corneal portion comprises a colored portion, and wherein both the substrate and scleral portions comprise a therapeutic compound and are degradable. 
     
     
         22 . A device for treating and managing diseased ocular tissue in the bulbar conjunctiva, comprising:
 a contact lens substrate comprising:   a substantially elliptical corneal portion;   a limbus portion located radially about the corneal portion; and   a scleral portion located radially about the substrate;   
       wherein the scleral portion extends nasaly and temporally to overlay nasal and temporal bulbar conjunctiva and the sclera, to protect against ultraviolet damage and irritants.