Shunt device and method for treating glaucoma

Abstract

The present invention provides a shunt for the flow of aqueous humor from the anterior chamber of the eye to Schlemm's canal. The device comprises at least one lumen and optionally has at least one anchor extending from the proximal portion within the anterior chamber to assist in placement and anchoring of the device in the correct anatomic position.

1 . An aqueous humor shunt device to divert aqueous humor in an eye from the anterior chamber into Schlemm's canal, the shunt device comprising a distal portion having at least one terminal aspect sized and shaped to be received circumferentially within a portion of Schlemm's canal and a proximal portion having at least one terminal aspect sized and shaped to be received within the anterior chamber of the eye, wherein the distal portion has an outer diameter of from about 0.1 mm to about 0.5 mm and a length of from about 1 mm to 40 mm, wherein the device permits fluid communication from the proximal portion in the anterior chamber to the distal portion in Schlemm's canal.  
   
   
       2 . The device of  claim 1 , wherein the outer diameter of the distal portion is from about 0.23 mm to about 0.28 mm.  
   
   
       3 . The device of  claim 1 , wherein the outer diameter of the distal portion is from about 0.23 mm to about 0.26 mm.  
   
   
       4 . The device of  claim 1 , wherein the length of the distal portion is from about 1 mm to about 20 mm.  
   
   
       5 . The device of  claim 1 , wherein the length of the distal portion is from about 4 mm to about 7 mm.  
   
   
       6 . The device of  claim 1 , wherein the length of the distal portion is from about 6.0 mm.  
   
   
       7 . The device of  claim 1 , wherein the length of the proximal portion extends at least about 0.1 mm into the anterior chamber.  
   
   
       8 . The device of  claim 1 , wherein the proximal portion extends about 0.1 mm to about 3 mm into the anterior chamber.  
   
   
       9 . The device of  claim 1 , wherein the device is selectively coated with a therapeutic agent.  
   
   
       10 . The device of  claim 9 , wherein the device is selectively coated with a tissue growth promoting agent.  
   
   
       11 . The device of  claim 9 , wherein the terminal aspects are selectively coated with a tissue growth inhibiting agent.  
   
   
       12 . The device of  claim 1 , wherein the device permits a flow of aqueous humor therethrough at a rate of about 2.5 microliters per minute.  
   
   
       13 . The device of  claim 1 , wherein the shunt device is a dual lumen shunt.  
   
   
       14 . The device of  claim 13 , wherein the dual lumen is bifurcated for insertion into opposite directions within Schlemm's canal.  
   
   
       15 . The device of  claim 13 , wherein the dual lumen anchors the shunt.  
   
   
       16 . The shunt of  claim 13 , wherein the dual lumen shunt is extruded as a dual lumen tube and the individual lumens are partially separated during manufacture.  
   
   
       17 . The shunt of  claim 13 , wherein the dual lumen shunt is extruded as a single lumen and two single lumens are partially attached together during manufacture.  
   
   
       18 . An aqueous humor shunt device to divert aqueous humor in an eye from the anterior chamber into Schlemm's canal, the shunt device comprising a distal portion having at least one terminal aspect sized and shaped to be received circumferentially within a portion of Schlemm's canal and a proximal portion having at least one terminal aspect sized and shaped to be received within the anterior chamber of the eye, wherein the device permits fluid communication from the proximal portion in the anterior chamber to the distal portion in Schlemm's canal, and wherein the proximal portion has an anchor thereon to maintain the device in position when implanted in tissues.  
   
   
       19 . The device of  claim 18 , wherein the anchor extends circumferentially around the proximal portion of the device.  
   
   
       20 . The device of  claim 18 , wherein the anchor extends toward the iris when implanted in the eye.  
   
   
       21 . The device of  claim 18 , wherein the anchor extends away from the iris when implanted in the eye.  
   
   
       22 . The device of  claim 18 , wherein the anchor extends laterally relative to the iris when implanted in the eye.  
   
   
       23 . The device of  claim 18 , wherein the proximal portion has a plurality of anchors.  
   
   
       24 . The device of  claim 18 , wherein the anchor is inside the anterior chamber when the device is implanted in the eye.  
   
   
       25 . The device of  claim 18 , wherein the anchor is outside the anterior chamber when the device is implanted in the eye.  
   
   
       26 . The device of  claim 18 , wherein the shunt is anchored on a shelf of corneo-scleral tissue created by a surgeon when the device is implanted in the eye.  
   
   
       27 . The device of  claim 18 , wherein the terminal aspect of the proximal portion has an acute angle to facilitate passage into the anterior chamber.  
   
   
       28 . A method of implanting the anchored aqueous humor shunt device of  claim 1  or  claim 18  to divert aqueous humor in an eye from the anterior chamber into Schlemm's canal, comprising: 
 a. creating a conjunctival flap and a partial thickness scleral flap dissected half-thickness into clear cornea;    b. dissecting the flap anteriorly to unroof the outer wall of Schlemm's canal;    c. continuing the dissection along a more shallow plane to create a corneo-scleral shelf over the trabecular meshwork;    d. inserting the device into Schlemm's canal and the anterior chamber within the angle between the iris and the cornea; and    e. closing the scleral flap and conjunctival wound.    
   
   
       29 . The method of  claim 28 , wherein the device is further anchored by the shelf.  
   
   
       30 . The method of  claim 28 , wherein Schlemm's canal is injected with a viscoelastic agent and/or a mitotic agent prior to insertion of the device.  
   
   
       31 . The method of  claim 28 , wherein the distal portion of the device is inserted into Schlemm's canal before the posterior portion is inserted into the anterior chamber.  
   
   
       32 . The method of  claim 28 , wherein the distal portion of the device is inserted into Schlemm's canal after the posterior portion is inserted into the anterior chamber.