Ocular Implant System and Method

Abstract

An ocular implant and delivery system having a channel tool adapted to extend through at least a portion of Schlemm's canal of a human eye and to determine whether the Schlemm's canal portion provides a suitable location for the delivery of an ocular implant; an ocular implant adapted to be disposed within Schlemm's canal of a human eye; and a cannula comprising a distal opening adapted to deliver the channel tool and the ocular implant into Schlemm's canal of the eye. The invention also provides a method of treating glaucoma in a human eye including the steps of inserting a distal exit port of a cannula at least partially into Schlemm's canal of the eye; delivering a channel tool through the cannula into Schlemm's canal; delivering an ocular implant through the cannula into Schlemm's canal; and removing the channel tool and the cannula from the eye while leaving the ocular implant in place within Schlemm's canal.

1 . An ocular implant and delivery system comprising:
 a channel tool adapted to extend through at least a portion of Schlemm's canal of a human eye and to determine whether the Schlemm's canal portion provides a suitable location for the delivery of an ocular implant;   an ocular implant adapted to be disposed within Schlemm's canal of a human eye; and   a cannula comprising a distal opening adapted to deliver the channel tool and the ocular implant into Schlemm's canal of the eye.   
     
     
         2 . The system of  claim 1  wherein the channel tool is further adapted to open a channel within the Schlemm's canal portion. 
     
     
         3 . The system of  claim 1  further comprising a proximal control adapted to be operated from exterior to the eye to move the channel opening tool and the ocular implant when the distal opening of the cannula is within the eye. 
     
     
         4 . The system of  claim 1  wherein the channel opening tool is configured to be disposed within the ocular implant and to move with respect to the ocular implant. 
     
     
         5 . The system of  claim 1  wherein the channel opening tool comprises a coil. 
     
     
         6 . The system of  claim 1  further comprising a fluid and a fluid injection mechanism adapted to inject the fluid into Schlemm's canal of the eye through the cannula. 
     
     
         7 . The system of  claim 6  wherein the channel opening tool comprises a fluid lumen, the fluid injection mechanism being adapted to inject fluid through the channel opening tool fluid lumen. 
     
     
         8 . The system of  claim 7  wherein the channel opening tool further comprises a distal opening communicating with the fluid lumen. 
     
     
         9 . The system of  claim 7  wherein the channel opening tool further comprises a liner tube surrounding the fluid lumen. 
     
     
         10 . The system of  claim 6  wherein the fluid injection mechanism comprises a piston disposed in a cylinder. 
     
     
         11 . The system of  claim 10  wherein the proximal control comprises a handle, the fluid injection mechanism further comprising an injection tube extending from an outlet of the cylinder to the handle. 
     
     
         12 . The system of  claim 6  wherein the fluid comprises a dilatation agent adapted to dilate tissue within the Schlemm's canal portion. 
     
     
         13 . A method of treating glaucoma in a human eye comprising:
 inserting a distal exit port of a cannula at least partially into Schlemm's canal of the eye;   delivering a channel tool through the cannula into Schlemm's canal;   delivering an ocular implant through the cannula into Schlemm's canal; and   removing the channel tool and the cannula from the eye while leaving the ocular implant in place within Schlemm's canal.   
     
     
         14 . The method of  claim 13  further comprising delivering a dye through the channel tool and observing the behavior of the dye to identify the location of obstructions within Schlemm's canal. 
     
     
         15 . The method of  claim 13  further comprising opening a channel in Schlemm's canal with the channel tool. 
     
     
         16 . The method of  claim 15  wherein the opening step comprises moving the channel tool within Schlemm's canal. 
     
     
         17 . The method of  claim 15  wherein the opening step comprises delivering a fluid through the channel tool. 
     
     
         18 . The method of  claim 17  further comprises moving the fluid through an obstruction within Schlemm's canal to increase fluid communication between adjacent segments of Schlemm's canal. 
     
     
         19 . The method of  claim 17  wherein the fluid comprises a dilatation agent adapted to dilate tissue within the Schlemm's canal portion. 
     
     
         20 . The method of  claim 17  wherein the fluid comprises a therapeutic agent. 
     
     
         21 . The method of  claim 13  wherein the delivering steps comprise delivering the channel opening tool and the ocular implant without removing the distal tip of the cannula from the eye. 
     
     
         22 . The method of  claim 13  further comprising moving the channel opening tool and the ocular implant with respect to each other within Schlemm's canal. 
     
     
         23 . The method of  claim 13  wherein the delivering steps comprise delivering the ocular implant over the channel opening tool. 
     
     
         24 . The method of  claim 13  wherein the inserting step comprises inserting the distal exit port of the cannula at least partially into Schlemm's canal of the eye through an ab interno approach. 
     
     
         25 . The method of  claim 13  wherein the inserting step comprises inserting the distal exit port of the cannula at least partially into Schlemm's canal of the eye through an ab externo approach.