Shunt device and method for treating glaucoma

Abstract

Surgical methods and related medical devices for treating glaucoma are disclosed. The method comprises trabecular bypass surgery, which involve bypassing diseased trabecular meshwork with the use of a seton implant. The seton implant is used to prevent a healing process known as filling in, which has a tendency to close surgically created openings in the trabecular meshwork. The surgical method and novel implant are addressed to the trabecular meshwork, which is a major site of resistance to outflow in glaucoma. In addition to bypassing the diseased trabecular meshwork at the level of the trabecular meshwork, existing outflow pathways are also used or restored. The seton implant is positioned through the trabecular meshwork so that an inlet end of the seton implant is exposed to the anterior chamber of the eye and an outlet end is positioned into fluid collection channels at about an exterior surface of the trabecular meshwork or up to the level of aqueous veins.

1 . An ocular device comprising: 
 a body for implantation into Schlemm's canal of an eye comprising a portion for insertion into the canal, and a portion sized to extend from a position within the canal to a position within an anterior chamber of the eye; and    wherein the body is configured and dimensioned such that implantation of the body in living tissue of the canal permits dynamic flow of aqueous humor toward a venous system of the eye; and    wherein the device is coated with a therapeutic agent.    
   
   
       2 . An ocular device comprising: 
 a body for implantation into Schlemm's canal of a living eye comprising a portion for insertion into the canal, and a portion sized to extend from a position within the canal to a position within an anterior chamber of the eye; and    wherein the body is configured and dimensioned such that implantation of the body in living tissue of the canal permits dynamic flow of aqueous humor toward an episcleral venous system of the eye; and    wherein the device comprises a therapeutic agent.    
   
   
       3 . The ocular device of  claim 2 , wherein the body is configured and dimensioned to permit dynamic flow of aqueous humor at a flow rate below that which would cause hypotony in the eye.  
   
   
       4 . The ocular device of  claim 2 , wherein the body is configured and dimensioned to permit dynamic flow of aqueous humor at a flow rate sufficient to maintain intraocular pressure above that which would cause hypotony in the eye.  
   
   
       5 . The ocular device of  claim 2 , wherein the body is configured and dimensioned to permit dynamic flow of aqueous humor at a flow rate that maintains intraocular pressure at a substantially normal pressure.  
   
   
       6 . The ocular device of  claim 2 , wherein a portion of the body for insertion into Schlemm's canal is flexible, and the flexible portion is adapted to conform to a radius of curvature of about 6 mm.  
   
   
       7 . The ocular device of  claim 2 , wherein the body comprises a substantially tubular body comprising open ends, and wherein the tubular body defines an aqueous humor directing channel extending between ends of the tubular body that is sized to permit flow of aqueous humor therein.  
   
   
       8 . The ocular device of  claim 7 , wherein the tubular body comprises first and second integrally formed sections disposed transverse to each other.  
   
   
       9 . The ocular device of  claim 7 , wherein the tubular body has an outer diameter of between 0.03 mm and 0.5 mm.  
   
   
       10 . The ocular device of  claim 7 , wherein the tubular body defines an aqueous humor directing channel with a maximum width of 1.5 mm.  
   
   
       11 . The ocular device of  claim 7 , wherein the tubular body further comprises an anchor portion for stabilizing the tubular body in Schlemm's canal.  
   
   
       12 . The ocular device of  claim 7 , wherein the tubular body further comprises a retention portion for stabilizing the tubular body in Schlemm's canal.  
   
   
       13 . The ocular device of  claim 7 , wherein the tubular body comprises an arcuate outer surface.  
   
   
       14 . The ocular device of  claim 7 , wherein the tubular body comprises a cylindrical outer cross-section.  
   
   
       15 . The ocular device of  claim 7 , wherein the tubular body is curved.  
   
   
       16 . The ocular device of  claim 2 , wherein the device further comprises a unidirectional valve.  
   
   
       17 . The ocular device of  claim 2 , wherein at least a portion of the device comprises a solid material.  
   
   
       18 . The ocular device of  claim 17 , wherein the device comprises a V-shape.  
   
   
       19 . The ocular device of  claim 17 , wherein the device comprises an inlet section and a distal section, wherein the distal section extends at an angle between about 30 degrees to about 150 degrees with reference to the inlet section.  
   
   
       20 . The ocular device of  claim 17 , wherein the solid material is porous.  
   
   
       21 . The ocular device of  claim 2 , wherein a portion of the device for insertion into Schlemm's canal comprises a solid material.  
   
   
       22 . The ocular device of  claim 2 , wherein a portion of the device for positioning within the anterior chamber comprises a solid material.  
   
   
       23 . The ocular device of  claim 2 , wherein the portion for insertion within the anterior chamber has two lumens therethrough that facilitate the passage of fluid into the portion of the device that is inserted within Schlemm's canal.  
   
   
       24 . The ocular device of  claim 2 , wherein the device comprises an inlet section and a distal section, wherein the distal section extends at an angle between about 30 degrees to about 150 degrees with reference to the inlet section.  
   
   
       25 . The ocular device of  claim 2 , wherein the device comprises a V-shape.  
   
   
       26 . The ocular device of  claim 25 , wherein the aqueous humor is directed in a unidirectional manner within Schlemm's canal.  
   
   
       27 . The ocular device of  claim 25 , wherein the portion of the device for insertion into Schlemm's canal comprises an opening adjacent to a junction with the portion for positioning within the anterior chamber, to facilitate bi-directional flow of fluid within Schlemm's canal.  
   
   
       28 . An ocular device for use in an eye having an anterior chamber and a Schlemm's canal for relieving intraocular pressure by facilitating flow from the anterior chamber of the eye into Schlemm's canal, the implant comprising: 
 a proximal portion in fluid communication with a distal portion,    the proximal portion being sized and shaped to fit at least partially in the anterior chamber of the eye, and    the distal portion being sized and shaped to fit at least partially in Schlemm's canal of the eye;    wherein the device is coated with a therapeutic agent.    
   
   
       29 . An ocular device for use in a living eye having an anterior chamber and a Schlemm's canal for relieving intraocular pressure by facilitating drainage from the anterior chamber of the living eye into Schlemm's canal, the implant comprising: 
 a proximal portion in fluid communication with a distal portion,    the proximal portion being sized and shaped to fit at least partially in the anterior chamber of the eye, and    the distal portion being sized and shaped to fit at least partially in Schlemm's canal of the eye;    wherein the device comprises a therapeutic agent.    
   
   
       30 . The ocular device of  claim 29 , wherein the device further comprises an anchor portion for stabilizing the device within Schlemm's canal.  
   
   
       31 . The ocular device of  claim 29 , wherein the device further comprises a retention portion for stabilizing the device within Schlemm's canal.  
   
   
       32 . The ocular device of  claim 29 , wherein the distal portion comprises an arcuate outer surface.  
   
   
       33 . The ocular device of  claim 29 , wherein the device comprises a unidirectional valve.  
   
   
       34 . The ocular device of  claim 29 , wherein the distal portion is flexible, and the flexible portion is adapted to conform to a radius of curvature of about 6 mm.  
   
   
       35 . The ocular device of  claim 29 , wherein at least a portion of the device comprises a substantially tubular body comprising an open end.  
   
   
       36 . The ocular device of  claim 35 , wherein the tubular body has an outer diameter of between 0.03 mm and 0.5 mm.  
   
   
       37 . The ocular device of  claim 35 , wherein the tubular body defines an aqueous humor directing channel with a maximum width of 1.5 mm.  
   
   
       38 . The ocular device of  claim 35 , wherein the tubular body comprises a cylindrical outer cross-section.  
   
   
       39 . The ocular device of  claim 35 , wherein the tubular body is curved.  
   
   
       40 . The ocular device of  claim 29 , comprising a portion for insertion within the anterior chamber comprising two lumens therethrough that facilitate the passage of fluid into a portion of the device that is inserted within Schlemm's canal.  
   
   
       41 . The ocular device of  claim 29 , wherein the distal portion of the device comprises a solid material.  
   
   
       42 . The ocular device of  claim 29 , wherein the proximal portion comprises a solid material.  
   
   
       43 . The ocular device of  claim 29 , wherein at least a portion of the device comprises a solid material.  
   
   
       44 . The ocular device of  claim 43 , wherein the solid material is porous.  
   
   
       45 . The ocular device of  claim 43 , wherein the device comprises a V-shape.  
   
   
       46 . The ocular device of  claim 43 , wherein the device comprises an inlet section and a distal section, wherein the distal section extends at an angle between about 30 degrees to about 150 degrees with reference to the inlet section.  
   
   
       47 . The ocular device of  claim 29 , wherein the device comprises an inlet section and a distal section, wherein the distal section extends at an angle between about 30 degrees to about 150 degrees with reference to the inlet section.  
   
   
       48 . The ocular device of  claim 29 , wherein the device comprises a V-shape.  
   
   
       49 . The ocular device of  claim 48 , wherein the device directs aqueous humor in a unidirectional manner within Schlemm's canal.  
   
   
       50 . The ocular device of  claim 48 , wherein the distal portion of the device comprises an opening adjacent to a junction with the proximal portion, to facilitate bi-directional flow of fluid within Schlemm's canal.