Injectable glaucoma device

Abstract

A glaucoma device includes an aqueous tube shunt implant with a foldable reservoir plate for injecting below the conjunctiva of a patient's eye via a hollow cannula. The device has an internal ostium with a flared lip at one end of a shaft having a flattened wing extending to the sides. A foldable plate and reservoir are provided at the at the other end of the shaft and connected to an external ostium of the shaft. The flattened wing presents a flat surface to the overlying conjunctiva and helps position the device when used. The device is preferably made of silicone or acrylic so that the entire implant is foldable and may be rolled up for insertion via the cannula. Other improvements and a method for implanting the device are disclosed as well.

What is claimed is:  
     
         1 . A glaucoma device for implanting in the eye of a patient to relieve intraocular pressure, the device comprising: 
 a drainage shaft;    an internal ostium at one end of the drainage shaft, the internal ostium having a flared lip;    an external ostium adjacent the second end of the drainage shaft on an upper side of the shaft;    a foldable plate connected to the second end of the drainage shaft; and    a pair of foldable wings extending from each of the left and right sides of the drainage shaft.    
     
     
         2 . A glaucoma device according to  claim 1 , wherein the foldable wings and foldable reservoir plate are made of a biocompatible material.  
     
     
         3 . A glaucoma device according to  claim 2 , wherein the biocompatible material is one of PMMA, a silicone and an acrylic.  
     
     
         4 . A glaucoma device according to  claim 1 , wherein the drainage shaft has a diameter of about 350 microns and the internal ostium has a diameter of about 500 microns.  
     
     
         5 . A glaucoma device according to  claim 1 , further comprising a longitudinal pigmented stripe on the drainage shaft.  
     
     
         6 . A glaucoma device according to  claim 5 , wherein the pigmented stripe is colored differently from tissues found in a human eye.  
     
     
         7 . A glaucoma device according to  claim 5 , wherein the drainage shaft wall has a reduced thickness where the pigmented stripe is located relative to the remainder of the drainage shaft wall.  
     
     
         8 . A glaucoma device according to  claim 1 , further comprising a ligature suture constrictably tied around the end of the drainage shaft adjacent the external ostium.  
     
     
         9 . A glaucoma device according to  claim 2 , wherein the plate and wings are rolled to have a diameter which is about the same as a shaft diameter of the drainage shaft.  
     
     
         10 . A glaucoma shunt implantation kit comprising: 
 a glaucoma shunt having a drainage shaft, an internal ostium at one end of the drainage shaft, the internal ostium having a flared lip, an external ostium adjacent the second end of the drainage shaft on an upper side of the shaft, a foldable plate connected to the second end of the drainage shaft, a pair of foldable wings extending from each of the left and right sides of the drainage shaft; and    a hollow cannula injector having means for pushing the glaucoma shunt through the injector after the glaucoma shunt has been inserted within the injector with the plate and wings folded to a diameter less than an inner diameter of the injector.    
     
     
         11 . A kit according to  claim 10 , wherein the cannula injector can flex perpendicular to its longitudinal axis to facilitate implantation of the glaucoma shunt.  
     
     
         12 . A kit according to  claim 10 , wherein the glaucoma shunt is made of a biocompatible material.  
     
     
         13 . A kit according to  claim 12 , wherein the biocompantible material is selected from the group consisting of PMMA, acrylic and silicone.  
     
     
         14 . A kit according to  claim 10 , wherein the inner diameter of the injector is between 500 and 700 microns.  
     
     
         15 . A method of implanting a glaucoma shunt in a patient's eye, comprising: 
 providing a glaucoma shunt having a drainage shaft, an internal ostium at one end of the drainage shaft, the internal ostium having a flared lip, an external ostium adjacent the second end of the drainage shaft on an upper side of the shaft, a foldable plate connected to the second end of the drainage shaft, a pair of foldable wings extending from each of the left and right sides of the drainage shaft;    folding the glaucoma shunt to fit within a hollow cannula injector;    providing an implant opening in the patient's eye;    inserting the cannula injector with the glaucoma shunt through the implant opening;    injecting the glaucoma shunt below a conjunctiva of the patient's eye;    positioning the glaucoma shunt with the internal ostium inside the patient's eye and the wings and plate unfolded;    removing the cannula injector; and    closing the implant opening.    
     
     
         16 . A method according to  claim 15 , wherein providing the implant opening comprises performing a laser sclerostomy on a patient's eye to create the implant opening.  
     
     
         17 . A method according to  claim 16 , wherein the glaucoma shunt further comprises a longitudinal pigmented stripe on the drainage shaft, the method further comprising using a laser, after injecting and positioning the glaucoma shunt, to make fenestrations in the drainage shaft where the pigmented stripe is located.  
     
     
         18 . A method according to  claim 16 , further comprising tightening a ligature suture around the drainage shaft to to constrict the initial flow of aqueous through the glaucoma shunt.  
     
     
         19 . A method according to  claim 15 , wherein providing the implant opening comprises using the site of a previous trabeculectomy as the implant opening.  
     
     
         20 . A method according to  claim 19 , wherein the glaucoma shunt further comprises a longitudinal pigmented stripe on the drainage shaft, the method further comprising using a laser, after injecting and positioning the glaucoma shunt, to make fenestrations in the drainage shaft where the pigmented stripe is located.  
     
     
         21 . A method according to  claim 16 , further comprising tightening a ligature suture around the drainage shaft to to constrict the initial flow of aqueous through the glaucoma shunt.