Indwelling shunt device and methods for treating glaucoma

Abstract

The present invention is directed to a novel indwelling shunt implant and an associated surgical method for the treatment of glaucoma in which the implant device comprises at least one spiral body and/or grooved or corrugated body and is placed to divert aqueous humor from the anterior chamber of the eye into Schlemm's canal, the collector channels, or the aqueous venous system or to distribute aqueous fluid within Schlemm's canal. The present invention is further directed to providing a permanent, indwelling shunt to provide increased egress of aqueous humor from the anterior chamber to Schlemm's canal, collector channels, or aqueous venous system for glaucoma management.

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 wherein the terminal aspect is an open coil and a proximal portion having at least one terminal aspect sized and shaped to be received within the anterior chamber of the eye, wherein device permits fluid communication from the proximal portion in the anterior chamber to the distal portion in Schlemm's canal.  
   
   
       2 . The shunt device of  claim 1  where in the distal end terminates in a ball shape.  
   
   
       3 . The shunt device of  claim 2  wherein the ball shape is an insert in the distal end.  
   
   
       4 . The shunt device of  claim 2  wherein the ball shape is formed from the coil of the distal end.  
   
   
       5 . The shunt device of  claim 1  wherein the proximal end of the shunt is a dual lumen spring  
   
   
       6 . The shunt device of  claim 1  wherein the shunt is made from shape memory materials.  
   
   
       7 . The shunt device of  claim 1  wherein the shunt is from 1.0 mm to 40.0 mm in length and an outer diameter of between about 0.1 to about 0.5 mm  
   
   
       8 . 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 wherein the terminal aspect comprises a flexible member having at least on conduit for fluid flow on the exterior of the flexible member and a proximal portion having at least one terminal aspect sized and shaped to be received within the anterior chamber of the eye, wherein device permits fluid communication from the proximal portion in the anterior chamber to the distal portion in Schlemm's canal.  
   
   
       9 . The shunt of  claim 8  wherein the flexible member has spiral or helical ridges running from the proximal to the distal end which define the conduit for fluid flow.  
   
   
       10 . The shunt of  claim 7  wherein the flexible member has straight or undulating ridges running from the proximal to the distal end which define the conduit for fluid flow.  
   
   
       11 . The shunt device of  claim 8  wherein the shunt is from 1.0 mm to 40.0 mm in length and an outer diameter of between about 0.1 to about 0.5 mm  
   
   
       12 . An aqueous humor shunt device to divert aqueous humor within Schlemm's canal, the shunt device comprising a distal portion having at least one terminal aspect sized and shaped to be received wholly within a portion of Schlemm's canal wherein the terminal aspect comprises a flexible member having ridges that define at least one conduit for fluid flow on the exterior of the flexible member, wherein the device permits fluid communication along the shunt within Schlemm's canal.  
   
   
       13 . The shunt of  claim 12  wherein the flexible member has spiral or helical ridges running from the proximal to the distal end which define the conduit for fluid flow.  
   
   
       14 . The shunt of  claim 12  wherein the flexible member has straight or undulating ridges running from the proximal to the distal end which define the conduit for fluid flow.  
   
   
       15 . The shunt device of  claim 12  wherein the shunt is from 1.0 mm to 40.0 mm in length and an outer diameter of between about 0.1 to about 0.5 mm  
   
   
       16 . An aqueous humor shunt device to divert aqueous humor within Schlemm's canal, the shunt device comprising a distal portion having at least one terminal aspect sized and shaped to be received wholly within a portion of Schlemm's canal wherein the terminal aspect comprises an open coil having a lumen there through wherein the device permits fluid communication along the shunt within Schlemm's canal.  
   
   
       17 . The shunt device of  claim 16  where in the distal end terminates in a ball shape.  
   
   
       18 . The shunt device of  claim 17  wherein the ball shape is an insert in the distal end.  
   
   
       19 . The shunt device of  claim 17  wherein the ball shape is formed from the coil of the distal end.  
   
   
       20 . The shunt device of  claim 16  wherein the shunt is made from shape memory materials.  
   
   
       21 . The shunt device of  claim 16  wherein the shunt is from 1.0 mm to 40.0 mm in length and an outer diameter of between about 0.1 to about 0.5 mm  
   
   
       22 . An aqueous humor shunt device to divert aqueous humor within Schlemm's canal, the shunt device comprising a distal portion having at least one terminal aspect sized and shaped to be received wholly within a portion of Schlemm's canal wherein the terminal aspect comprises a corrugated member having at least one aperture in the corrugation that defines at least one conduit for fluid flow on the interior of the flexible member, wherein device permits fluid communication inside the shunt within Schlemm's canal.  
   
   
       23 . The device according to  claim 23  wherein the corrugations are formed by transverse members alternating above and below a pair of longitudinal rails.  
   
   
       24 . The device according to  claim 23  wherein the corrugations are sinusoidal.  
   
   
       25 . The device according to  claim 25  wherein the corrugations are squared off.  
   
   
       26 . The device according to  claim 23  wherein the hunt is from 1.0 mm to 40.0 mm in length and an outer diameter of between about 0.1 to about 0.5 mm.  
   
   
       27 . A method of treating glaucoma in a patient in need thereof comprising: 
 First introducing a second end into Schlemm's canal wherein the second end comprises an open coil or stent;    Second introducing a first end of a shunt device into the anterior chamber of the eye, wherein the first end comprises a silicone tube, thereby allowing aqueous fluid to flow from the anterior chamber into Schlemm's canal.