Apparatuses and methods for treating ophthalmic diseases and disorders

Abstract

The invention relates generally to the fields of biology and health sciences. More particularly, the invention relates to compositions and methods for modulating cellular physiology and pathological processing using a combination of compounds that can be found in amniotic membrane tissue and umbilical cord tissue preparations.

What is claimed is: 
     
         1 . An apparatus for treating dry eye or other diseases or disorders of the eye, by insertion of the device onto the surface of the eye of a patient in need thereof, wherein the apparatus comprises: one or more flexible tubular structures, wherein the one or more flexible tubular structures comprise a material selected from the group consisting of: ethylene vinyl acetate (EVA); polydimethylsiloxane (PDMS); polymethylmetacrylate (PMMA); polyethylene teraphthalate (PET); polycarbonate (PC); hydrogels; polyvinyl chloride (PVC); rubber; latex; polyethylene (PE); silicone; polytetrafluoroethylene (PTFE); polyurethane (PU); umbilical cord tissue; amniotic membrane tissue; placental tissue; chorion tissue and any combination thereof. 
     
     
         2 . The apparatus according to  claim 1 , wherein the apparatus is configured to reside in at least one of the group consisting of: superior conjunctiva fornix, inferior conjunctiva fornix and combinations thereof. 
     
     
         3 . The apparatus according to  claim 1 , wherein the apparatus is configured to reside in both conjunctiva fornices. 
     
     
         4 . The apparatus according to  claim 1 , wherein the apparatus deepen the fornix tear reservoir by stretching the conjunctival sac. 
     
     
         5 . The apparatus according to  claim 1 , wherein the apparatus induces blinking. 
     
     
         6 . The apparatus according to  claim 1 , wherein the one or more flexible tubular structures have a length of about 0.5 cm to about 15 cm. 
     
     
         7 . The apparatus according to  claim 1 , wherein the one or more flexible tubular structures have a circumference of about 2 cm to about 15 cm. 
     
     
         8 . The apparatus according to  claim 7 , wherein the one or more flexible tubular structures have a circumference of about 4 cm to about 12 cm. 
     
     
         9 . The apparatus according to  claim 1 , wherein the one or more flexible tubular structures have an outside diameter of about 0.5 cm to about 5.0 cm. 
     
     
         10 . The apparatus according to  claim 9 , wherein the one or more flexible tubular structures have an outside diameter of about 1.2 cm to about 3.5 cm. 
     
     
         11 . The apparatus according to  claim 1 , wherein the one or more flexible tubular structures have a cross sectional diameter of about 0.01 cm to about 1.0 cm. 
     
     
         12 . The apparatus according to  claim 11 , wherein the one or more flexible tubular structures have a cross sectional diameter of about 0.05 cm to about 0.2 cm 
     
     
         13 . The apparatus according to  claim 1 , wherein the one or more flexible tubular structures contains at least one porous inlet and at least one porous outlet. 
     
     
         14 . The apparatus according to  claim 13 , wherein the at least one porous inlet and the at least one porous outlet taken together form an osmotic pump when in contact with tears in the patient's eye. 
     
     
         15 . The apparatus according to  claim 1 , wherein the apparatus is configured to deliver one or more therapeutic agents to the patient. 
     
     
         16 . The apparatus according to  claim 15 , wherein the therapeutic agent is delivered by diffusion through the net movement of solute from an area of high concentration to an area of low concentration. 
     
     
         17 . The apparatus according to  claim 15 , wherein the therapeutic agent is delivered through compression of the apparatus via blinking. 
     
     
         18 . The apparatus according to  claim 15 , wherein the one or more therapeutic agents may be incorporated into the material of the one or more flexible tubular structures, on the surface of the one or more flexible tubular structures, inside the one or more flexible tubular structures or combinations thereof. 
     
     
         19 . The apparatus according to  claim 18 , wherein the one or more flexible tubular structures are configured to dissolve when in contact with tears in the patient's eye. 
     
     
         20 . The apparatus according to  claim 15 , wherein the one or more therapeutic agents may be frictionally engaged onto a surface of the one or more flexible tubular structures, into the one or more flexible tubular structures or a combination thereof. 
     
     
         21 . The apparatus according to  claim 20 , wherein the one or more therapeutic agents may be one or more sheets covering from about 25% to about 100% of the opening defined by the outer circumference of the one or more flexible tubular structures. 
     
     
         22 . The apparatus according to  claim 15 , wherein the one or more therapeutic agents is selected from the group consisting of: antibacterial antibiotics, synthetic antibacterials, antifungal antibiotics, synthetic antifungals, umbilical cord tissue, amniotic membrane tissue, placental tissue, chorion tissue, antineoplastic agents, steroidal anti-inflammatory agents, non-steroidal anti-inflammatory agents, anti-allergic agents, glaucoma-treating agents, antiviral agents, anti-mycotic agents, and any combination thereof, wherein the one of more therapeutic agents may be dispersed in a polymer, wherein the polymer is selected from the group consisting of: ethylene vinyl acetate (EVA); polydimethylsiloxane (PDMS); polymethylmetacrylate (PMMA); polyethylene teraphthalate (PET); polycarbonate (PC); hydrogels; polyvinyl chloride (PVC); rubber; latex; polyethylene (PE); silicone; polytetrafluoroethylene (PTFE); and polyurethane (PU). 
     
     
         23 . The apparatus according to  claim 22 , wherein the umbilical cord tissue, amniotic membrane tissue, placental tissue or chorion tissue may be present in any form from the group consisting of: lyophilized, fresh, sheet, morselized, powder matrix, extract, purified extract, previously frozen, suspension and on a physiologically acceptable support. 
     
     
         24 . The apparatus according to  claim 1 , wherein the apparatus further comprises a power source at least one positive electrode and at least one negative electrode wherein the apparatus is configured to introduce an electrical stimulus between about 0.1 milliamps and about 50 milliamps to the muscles of the patient's eyelids. 
     
     
         25 . Use of an apparatus according to  claim 1 , to promote an increase in tissue sensation, induce a patient to blink and tear more frequently to prevent dry eye, increase Tear Breakup Time in a patient suffering from dry eye disease, increase tear osmolarity in a patient suffering from dry eye disease, decrease corneal straining in a patient suffering from dry eye disease, increase the score on Schirmer's test in a patient suffering from dry eye disease, promote nerve growth in a contacted tissue, promote nerve regeneration in a contacted tissue, reduce an inflammatory response in a contacted tissue, or a combination thereof. 
     
     
         26 . The use according to  claim 25 , wherein the increase in nerve growth is between about 10% and about 100%. 
     
     
         27 . The use according to  claim 25 , wherein the increase in nerve regeneration is between about 10% and about 100%. 
     
     
         28 . An apparatus for treating dry eye or other diseases or disorders of the eye, by insertion of the apparatus onto the surface of the eye of a patient in need thereof, wherein the apparatus comprises:
 one or more flexible tubular structures, wherein the one or more flexible tubular structures comprise a material selected from the group consisting of: ethylene vinyl acetate (EVA); polydimethylsiloxane (PDMS); polymethylmetacrylate (PMMA); polyethylene teraphthalate (PET); polycarbonate (PC); hydrogels; polyvinyl chloride (PVC); rubber; latex; polyethylene (PE); silicone; polytetrafluoroethylene (PTFE); polyurethane (PU); umbilical cord tissue; amniotic membrane tissue; placental tissue; chorion tissue and any combination thereof; and   one or more flexible fastening cuffs,   wherein the inner surface of the one or more flexible fastening cuffs are frictionally engaging the outer surface of the one or more flexible tubular structures.   
     
     
         29 . The apparatus according to  claim 28 , wherein the apparatus is configured to reside in at least one of the group consisting of: superior conjunctiva fornix, inferior conjunctiva fornix and combinations thereof. 
     
     
         30 . The apparatus according to  claim 28 , wherein the apparatus is configured to reside in both conjunctiva fornices. 
     
     
         31 . The apparatus according to  claim 28 , wherein the apparatus deepen the fornix tear reservoir by stretching the conjunctival sac. 
     
     
         32 . The apparatus according to  claim 28 , wherein the apparatus induces blinking. 
     
     
         33 . The apparatus according to  claim 28 , wherein the one or more flexible tubular structures have a length of about 0.5 cm to about 15 cm. 
     
     
         34 . The apparatus according to  claim 28 , wherein the one or more flexible tubular structures have a circumference of about 2 cm to about 15 cm. 
     
     
         35 . The apparatus according to  claim 34 , wherein the one or more flexible tubular structures have a circumference of about 4 cm to about 12 cm. 
     
     
         36 . The apparatus according to  claim 28 , wherein the one or more flexible tubular structures have an outside diameter of about 0.5 cm to about 5.0 cm. 
     
     
         37 . The apparatus according to  claim 36 , wherein the one or more flexible tubular structures have an outside diameter of about 1.2 cm to about 3.5 cm. 
     
     
         38 . The apparatus according to  claim 28 , wherein the one or more flexible tubular structures have a cross sectional diameter of about 0.01 cm to about 1.0 cm. 
     
     
         39 . The apparatus according to  claim 38 , wherein the one or more flexible tubular structures have a cross sectional diameter of about 0.05 cm to about 0.2 cm 
     
     
         40 . The apparatus according to  claim 28 , wherein the one or more flexible tubular structures contains at least one porous inlet and at least one porous outlet. 
     
     
         41 . The apparatus according to  claim 28 , wherein the one or more flexible fastening cuffs comprises a material selected from the group consisting of: ethylene vinyl acetate (EVA); polydimethylsiloxane (PDMS); polymethylmetacrylate (PMMA); polyethylene teraphthalate (PET); polycarbonate (PC); hydrogels; polyvinyl chloride (PVC); rubber; latex; polyethylene (PE); silicone; polytetrafluoroethylene (PTFE); and polyurethane (PU). 
     
     
         42 . The apparatus according to  claim 40 , wherein the at least one porous inlet and the at least one porous outlet taken together form an osmotic pump when in contact with tears in the patient's eye. 
     
     
         43 . The apparatus according to  claim 28 , wherein the apparatus is configured to deliver one or more therapeutic agents to the patient. 
     
     
         44 . The apparatus according to  claim 43 , wherein the therapeutic agent is delivered by diffusion through the net movement of solute from an area of high concentration to an area of low concentration. 
     
     
         45 . The apparatus according to  claim 43 , wherein the therapeutic agent is delivered through compression of the apparatus via blinking. 
     
     
         46 . The apparatus according to  claim 43 , wherein the one or more therapeutic agents may be delivered from the one or more flexible fastening cuffs, the one or more flexible tubular structures or a combination thereof. 
     
     
         47 . The apparatus according to  claim 46 , wherein the one or more therapeutic agents may be incorporated into the material of the one or more flexible fastening cuffs, on the surface of the one or more flexible fastening cuffs or combinations thereof. 
     
     
         48 . The apparatus according to  claim 47 , wherein the one or more flexible fastening cuffs are configured to dissolve when in contact with tears in the patient's eye. 
     
     
         49 . The apparatus according to  claim 43 , wherein the one or more therapeutic agents may be incorporated into the material of the flexible tubular structure, on the surface of the flexible tubular structure, inside the flexible tubular structure or combinations thereof. 
     
     
         50 . The apparatus according to  claim 49 , wherein the one or more flexible tubular structures are configured to dissolve when in contact with tears in the patient's eye. 
     
     
         51 . The apparatus according to  claim 43 , wherein the one or more therapeutic agents may be frictionally engaged between the one or more flexible fastening cuffs and the flexible tubular structure. 
     
     
         52 . The apparatus according to  claim 43 , wherein the one or more therapeutic agents may be one or more sheets covering from about 25% to about 100% of the opening defined by the outer circumference of the flexible tubular structure. 
     
     
         53 . The apparatus according to  claim 43 , wherein the one or more therapeutic agents is selected from the group consisting of: antibacterial antibiotics, synthetic antibacterials, antifungal antibiotics, synthetic antifungals, umbilical cord tissue, amniotic membrane tissue, placental tissue, chorion tissue, antineoplastic agents, steroidal anti-inflammatory agents, non-steroidal anti-inflammatory agents, anti-allergic agents, glaucoma-treating agents, antiviral agents, anti-mycotic agents, and any combination thereof, wherein the one of more therapeutic agents may be dispersed in a polymer, wherein the polymer is selected from the group consisting of: ethylene vinyl acetate (EVA); polydimethylsiloxane (PDMS); polymethylmetacrylate (PMMA); polyethylene teraphthalate (PET); polycarbonate (PC); hydrogels; polyvinyl chloride (PVC); rubber; latex; polyethylene (PE); silicone; polytetrafluoroethylene (PTFE); and polyurethane (PU). 
     
     
         54 . The apparatus according to  claim 53 , wherein the umbilical cord tissue, amniotic membrane tissue, placental tissue or chorion tissue may be present in any form from the group consisting of: lyophilized, fresh, sheet, morselized, powder matrix, extract, purified extract, previously frozen, suspension and on a physiologically acceptable support. 
     
     
         55 . The apparatus according to  claim 28 , wherein the apparatus further comprises a power source at least one positive electrode and at least one negative electrode wherein the apparatus is configured to introduce an electrical stimulus between about 0.1 milliamps and about 50 milliamps to the muscles of the patient's eyelids. 
     
     
         56 . Use of an apparatus according to  claim 28 , to promote an increase in tissue sensation, induce a patient to blink and tear more frequently to prevent dry eye, increase Tear Breakup Time in a patient suffering from dry eye disease, increase tear osmolarity in a patient suffering from dry eye disease, decrease corneal straining in a patient suffering from dry eye disease, increase the score on Schirmer's test in a patient suffering from dry eye disease, promote nerve growth in a contacted tissue, promote nerve regeneration in a contacted tissue, reduce an inflammatory response in a contacted tissue, or a combination thereof. 
     
     
         57 . The use according to  claim 56 , wherein the increase in nerve growth is between about 10% and about 100%. 
     
     
         58 . The use according to  claim 56 , wherein the increase in nerve regeneration is between about 10% and about 100%. 
     
     
         59 . An apparatus for treating dry eye or other diseases or disorders of the eye, by insertion of the device onto the surface of the eye of a patient in need thereof, wherein the apparatus comprises:
 at least one sheet comprising a material selected from the group consisting of: umbilical cord tissue; amniotic membrane tissue; placental tissue; chorion tissue; ethylene vinyl acetate (EVA); polydimethylsiloxane (PDMS); polymethylmetacrylate (PMMA); polyethylene teraphthalate (PET); fibrins; polycarbonate (PC); hydrogels; polyvinyl chloride (PVC); rubber; latex; polyethylene (PE); silicone; polytetrafluoroethylene (PTFE); polyurethane (PU) and combinations thereof; and   at least one tubular structure comprising a second material selected from the group consisting of: umbilical cord tissue; amniotic membrane tissue; placental tissue; chorion tissue; ethylene vinyl acetate (EVA); polydimethylsiloxane (PDMS); polymethylmetacrylate (PMMA); polyethylene teraphthalate (PET); fibrins; polycarbonate (PC); hydrogels; polyvinyl chloride (PVC); rubber; latex; polyethylene (PE); silicone; polytetrafluoroethylene (PTFE); polyurethane (PU) and combinations thereof,   wherein at least one sheet and at least one tubular structure are adhering to maintain physical contact with one another.   
     
     
         60 . The apparatus according to  claim 59 , wherein the apparatus is configured to reside in at least one of the group consisting of: superior conjunctiva fornix, inferior conjunctiva fornix and combinations thereof. 
     
     
         61 . The apparatus according to  claim 59 , wherein the apparatus is configured to reside in both conjunctiva fornices. 
     
     
         62 . The apparatus according to  claim 59 , wherein the apparatus induces blinking. 
     
     
         63 . The apparatus according to  claim 59 , wherein the apparatus deepens the fornix tear reservoir by stretching the conjunctival sac. 
     
     
         64 . The apparatus according to  claim 59 , wherein the at least one tubular structure has a circumference of about 2 cm to about 15 cm. 
     
     
         65 . The apparatus according to  claim 64 , wherein the at least one tubular structure has a circumference of about 4 cm to about 12 cm. 
     
     
         66 . The apparatus according to  claim 59 , wherein the at least one tubular structure has an outside diameter of about 0.5 cm to about 5.0 cm. 
     
     
         67 . The apparatus according to  claim 66 , wherein the at least one tubular structure has an outside diameter of about 1.2 cm to about 3.5 cm. 
     
     
         68 . The apparatus according to  claim 59 , wherein the at least one tubular structure has a cross sectional diameter of about 0.01 cm to about 1.0 cm. 
     
     
         69 . The apparatus according to  claim 68 , wherein the at least one tubular structure has a cross sectional diameter of about 0.05 cm to about 0.2 cm 
     
     
         70 . The apparatus according to  claim 59 , wherein the apparatus is configured to deliver one or more additional therapeutic agents to the patient. 
     
     
         71 . The apparatus according to  claim 70 , wherein the one or more additional therapeutic agents may be incorporated into the material of the at least one tubular structure, on the surface of the at least one tubular structure or combinations thereof. 
     
     
         72 . The apparatus according to  claim 71 , wherein the at least one tubular structure is configured to dissolve when in contact with tears in the patient's eye. 
     
     
         73 . The apparatus according to  claim 70 , wherein the one or more additional therapeutic agents is selected from the group consisting of: antibacterial antibiotics, synthetic antibacterials, antifungal antibiotics, synthetic antifungals, umbilical cord tissue, amniotic membrane tissue, placental tissue, chorion tissue, antineoplastic agents, steroidal anti-inflammatory agents, non-steroidal anti-inflammatory agents, anti-allergic agents, glaucoma-treating agents, antiviral agents, and anti-mycotic agents, wherein the one of more therapeutic agents may be dispersed in a polymer, wherein the polymer is selected from the group consisting of: ethylene vinyl acetate (EVA); polydimethylsiloxane (PDMS); polymethylmetacrylate (PMMA); polyethylene teraphthalate (PET); polycarbonate (PC); hydrogels; polyvinyl chloride (PVC); rubber; latex; polyethylene (PE); silicone; polytetrafluoroethylene (PTFE); and polyurethane (PU). 
     
     
         74 . The apparatus according to  claim 59 , wherein the umbilical cord tissue, amniotic membrane tissue, placental tissue or chorion tissue may be present in any form from the group consisting of: lyophilized, fresh, sheet, morselized, powder matrix, extract, purified extract, previously frozen, suspension and on a physiologically acceptable support. 
     
     
         75 . The apparatus according to  claim 59 , wherein the apparatus further comprises a power source at least one positive electrode and at least one negative electrode wherein the apparatus is configured to introduce an electrical stimulus between about 0.1 milliamps and about 50 milliamps to the muscles of the patient's eyelids. 
     
     
         76 . The apparatus according to  claim 59 , wherein the at least one tubular structure is formed upon a surface of the at least one sheet by use of a three-dimensional (3D) printer. 
     
     
         77 . The apparatus according to  claim 59 , wherein the at least one tubular structure is formed upon a surface of the at least one sheet by use of polymer extrusion means. 
     
     
         78 . Use of an apparatus according to  claim 59 , to promote an increase in tissue sensation, induce a patient to blink and tear more frequently to prevent dry eye, increase Tear Breakup Time in a patient suffering from dry eye disease, increase tear osmolarity in a patient suffering from dry eye disease, decrease corneal straining in a patient suffering from dry eye disease, increase the score on Schirmer's test in a patient suffering from dry eye disease, promote nerve growth in a contacted tissue, promote nerve regeneration in a contacted tissue, reduce an inflammatory response in a contacted tissue, or a combination thereof. 
     
     
         79 . The use according to  claim 78 , wherein the increase in nerve growth is between about 10% and about 100%. 
     
     
         80 . The use according to  claim 78 , wherein the increase in nerve regeneration is between about 10% and about 100%. 
     
     
         81 . An apparatus for treating dry eye or other diseases or disorders of the eye, by insertion of the device onto the surface of the eye of a patient in need thereof, wherein the apparatus comprises:
 at least one first sheet comprising a material selected from the group consisting of: umbilical cord tissue; amniotic membrane tissue; placental tissue; chorion tissue; ethylene vinyl acetate (EVA); polydimethylsiloxane (PDMS); polymethylmetacrylate (PMMA); polyethylene teraphthalate (PET); fibrins; polycarbonate (PC); hydrogels; polyvinyl chloride (PVC); rubber; latex; polyethylene (PE); silicone; polytetrafluoroethylene (PTFE); polyurethane (PU) and combinations thereof; and   at least one second sheet comprising a second material selected from the group consisting of: umbilical cord tissue; amniotic membrane tissue; placental tissue; chorion tissue; ethylene vinyl acetate (EVA); polydimethylsiloxane (PDMS); polymethylmetacrylate (PMMA); polyethylene teraphthalate (PET); fibrins; polycarbonate (PC); hydrogels; polyvinyl chloride (PVC); rubber; latex; polyethylene (PE); silicone; polytetrafluoroethylene (PTFE); polyurethane (PU) and combinations thereof,   wherein the at least one first sheet and the at least one second sheet are adhering to maintain physical contact with one another.   
     
     
         82 . The apparatus according to  claim 81 , wherein the apparatus is configured to reside in at least one of the group consisting of: superior conjunctiva fornix, inferior conjunctiva fornix and combinations thereof. 
     
     
         83 . The apparatus according to  claim 81 , wherein the apparatus is configured to reside in both conjunctiva fornices. 
     
     
         84 . The apparatus according to  claim 81 , wherein the apparatus induces blinking. 
     
     
         85 . The apparatus according to  claim 81 , wherein the apparatus deepens the fornix tear reservoir by stretching the conjunctival sac. 
     
     
         86 . The apparatus according to  claim 81 , wherein the apparatus has a circumference of about 2 cm to about 15 cm. 
     
     
         87 . The apparatus according to  claim 86 , wherein the apparatus has a circumference of about 4 cm to about 12 cm. 
     
     
         88 . The apparatus according to  claim 81 , wherein the apparatus has an outside diameter of about 0.5 cm to about 5.0 cm. 
     
     
         89 . The apparatus according to  claim 88 , wherein the apparatus has an outside diameter of about 1.2 cm to about 3.5 cm. 
     
     
         90 . The apparatus according to  claim 81 , wherein the apparatus is configured to deliver one or more additional therapeutic agents to the patient. 
     
     
         91 . The apparatus according to  claim 90 , wherein the one or more additional therapeutic agents may be incorporated into the material of the at least one first sheet, on the surface of the at least one first sheet, into the material of the at least one second sheet, on the surface of the at least one second sheet or combinations thereof. 
     
     
         92 . The apparatus according to  claim 91 , wherein the at least one first sheet, the at least one second sheet or combinations thereof are configured to dissolve when in contact with tears in the patient's eye. 
     
     
         93 . The apparatus according to  claim 90 , wherein the one or more additional therapeutic agents is selected from the group consisting of: antibacterial antibiotics, synthetic antibacterials, antifungal antibiotics, synthetic antifungals, umbilical cord tissue, amniotic membrane tissue, placental tissue, chorion tissue, antineoplastic agents, steroidal anti-inflammatory agents, non-steroidal anti-inflammatory agents, anti-allergic agents, glaucoma-treating agents, antiviral agents, and anti-mycotic agents, wherein the one of more therapeutic agents may be dispersed in a polymer, wherein the polymer is selected from the group consisting of: ethylene vinyl acetate (EVA); polydimethylsiloxane (PDMS); polymethylmetacrylate (PMMA); polyethylene teraphthalate (PET); polycarbonate (PC); hydrogels; polyvinyl chloride (PVC); rubber; latex; polyethylene (PE); silicone; polytetrafluoroethylene (PTFE); and polyurethane (PU). 
     
     
         94 . The apparatus according to  claim 81 , wherein the umbilical cord tissue, amniotic membrane tissue, placental tissue or chorion tissue may be present in any form from the group consisting of: lyophilized, fresh, sheet, morselized, powder matrix, extract, purified extract, previously frozen, suspension and on a physiologically acceptable support. 
     
     
         95 . The apparatus according to  claim 81 , wherein the apparatus further comprises a power source at least one positive electrode and at least one negative electrode wherein the apparatus is configured to introduce an electrical stimulus between about 0.1 milliamps and about 50 milliamps to the muscles of the patient's eyelids.