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 . A method for reducing side effects of glaucoma surgery, comprising; 
 providing a surgically implantable device adapted to provide fluid flow, wherein the device is coated with a therapeutic agent;    transporting aqueous humor from the anterior chamber of the eye to an internal anatomical structure of the eye by implantation of the surgical device; and    establishing a flow rate of the aqueous humor that reduces intraocular pressure without hypotony.    
   
   
       2 . A method for reducing side effects of glaucoma surgery, comprising; 
 providing a surgically implantable device adapted to provide fluid flow, wherein the device comprises a therapeutic agent;    transporting aqueous humor from the anterior chamber of the eye to an internal anatomical structure of the eye by implantation of the surgical device; and    establishing a flow rate of the aqueous humor that reduces intraocular pressure without hypotony.    
   
   
       3 . The method of  claim 2 , wherein the flow rate is below that which would cause hypotony in the eye.  
   
   
       4 . The method of  claim 2 , wherein the flow rate is sufficient to maintain intraocular pressure above that which would cause hypotony in the eye.  
   
   
       5 . The method of  claim 2 , wherein the flow rate maintains intraocular pressure at a substantially normal pressure.  
   
   
       6 . The method of  claim 2 , wherein the device comprises a unidirectional valve.  
   
   
       7 . The method of  claim 2 , wherein the device comprises a substantially tubular body comprising open ends.  
   
   
       8 . The method of  claim 7 , 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.  
   
   
       9 . The method of  claim 7 , wherein the internal anatomical structure of the eye is Schlemm's canal.  
   
   
       10 . The method of  claim 7 , wherein a portion of the body is designed for insertion into Schlemm's canal, wherein said portion of the device is flexible, and wherein the flexible portion is adapted to conform to a radius of curvature of about 6 mm.  
   
   
       11 . The method of  claim 7 , wherein the tubular body comprises first and second integrally formed sections disposed transverse to each other.  
   
   
       12 . The method of  claim 7 , wherein the tubular body has an outer diameter of between 0.03 mm and 0.5 mm.  
   
   
       13 . The method of  claim 7 , wherein the tubular body defines an aqueous humor directing channel with a maximum width up to 1.5 mm.  
   
   
       14 . The method of  claim 7 , wherein the tubular body further comprises an anchor portion for stabilizing the tubular body in Schlemm's canal.  
   
   
       15 . The method of  claim 7 , wherein the tubular body further comprises a retention portion for stabilizing the tubular body in Schlemm's canal.  
   
   
       16 . The method of  claim 7 , wherein the tubular body comprises an arcuate outer surface.  
   
   
       17 . The method of  claim 7 , wherein the tubular body comprises a cylindrical outer cross-section.  
   
   
       18 . The method of  claim 7 , wherein the tubular body is curved.  
   
   
       19 . The method of  claim 2 , wherein at least a portion of the device comprises a solid material.  
   
   
       20 . The method of  claim 19 , wherein the solid material is porous.  
   
   
       21 . The method of  claim 19 , wherein the device comprises a V-shape.  
   
   
       22 . The method of  claim 19 , 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.  
   
   
       23 . The method of  claim 2 , wherein a portion of the device is adapted for insertion into Schlemm's canal and comprises a solid material.  
   
   
       24 . The method of  claim 2 , wherein a portion of the device is adapted for insertion within the anterior chamber and comprises a solid material.  
   
   
       25 . The method of  claim 2 , wherein the device comprises a biocompatible material.  
   
   
       26 . The method 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.  
   
   
       27 . The method of  claim 2 , wherein the device comprises a V-shape.  
   
   
       28 . The method of  claim 27 , wherein the aqueous humor is transported in a unidirectional manner within Schlemm's canal.  
   
   
       29 . The method of  claim 27 , wherein a portion of the device is adapted for insertion into Schlemm's canal and comprises an opening adjacent to a junction with a portion for insertion within the anterior chamber, to facilitate bi-directional flow of fluid within Schlemm's canal.  
   
   
       30 . The method of  claim 29 , wherein the portion for insertion within Schlemm's canal comprises a lumen therethrough that directs the passage of fluid into Schlemm's canal.  
   
   
       31 . The method of  claim 29 , wherein the portion for insertion within the anterior chamber has a lumen therethrough that facilitates the passage of fluid into the portion of the device that is inserted within Schlemm's canal.  
   
   
       32 . The method of  claim 29 , 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.  
   
   
       33 . A method of treating glaucoma in a patient in need thereof comprising: 
 delivering into an eye of a patient an implantable channel forming body having an inlet section positioned in the anterior chamber and a distal section positioned in Schlemm's canal to facilitate flow of aqueous humor from the anterior chamber into Schlemm's canal;    conducting aqueous humor through the channel forming body to reduce intraocular pressure in the eye; and    providing at least one medication to the eye of the patient.    
   
   
       34 . The method of  claim 33 , wherein aqueous humor is drained at a flow rate is below that which would cause hypotony in the eye.  
   
   
       35 . The method of  claim 33 , aqueous humor is drained at a flow rate sufficient to maintain intraocular pressure above which would cause hypotony in the eye.  
   
   
       36 . The method of  claim 33 , aqueous humor is drained at a flow rate sufficient to maintain intraocular pressure at a substantially normal pressure.  
   
   
       37 . The method of  claim 33 , wherein the channel forming body comprises a therapeutic agent.  
   
   
       38 . The method of  claim 33 , wherein the channel forming body is coated with a therapeutic agent.  
   
   
       39 . The method of  claim 33 , wherein the 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.  
   
   
       40 . The method of  claim 33 , wherein the channel forming body has an outer diameter of between 0.03 mm and 0.5 mm.  
   
   
       41 . The method of  claim 33 , wherein the channel forming body defines an aqueous humor directing channel with a maximum width of 1.5 mm.  
   
   
       42 . The method of  claim 33 , wherein the channel forming body further comprises a portion for stabilizing the tubular body in Schlemm's canal.  
   
   
       43 . The method of  claim 33 , wherein the channel forming body comprises an arcuate outer surface.  
   
   
       44 . The method of  claim 33 , wherein the channel forming body comprises a cylindrical outer cross-section.  
   
   
       45 . The method of  claim 33 , wherein the channel forming body is curved.  
   
   
       46 . The method of  claim 33 , wherein the channel forming body comprises a unidirectional valve.  
   
   
       47 . The method of  claim 48 , wherein the channel forming body comprises a biocompatible material.  
   
   
       48 . The method of  claim 33 , wherein the channel forming body comprises a V-shape.  
   
   
       49 . The method of  claim 33 , wherein the channel forming body 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.  
   
   
       50 . The method of  claim 48 , wherein the aqueous humor is directed unidirectionally within Schlemm's canal.  
   
   
       51 . The method of  claim 48 , wherein a portion of the body for insertion into Schlemm's canal comprises an opening adjacent to a junction with a portion of the body for insertion within the anterior chamber, to facilitate bi-directional flow of fluid within Schlemm's canal.  
   
   
       52 . The method of  claim 51 , wherein the portion for insertion within Schlemm's canal comprises a lumen therethrough that directs the passage of fluid into Schlemm's canal.  
   
   
       53 . The method of  claim 51 , wherein the portion for insertion within the anterior chamber has a lumen therethrough that facilitates the passage of fluid into the portion of the device that is inserted within Schlemm's canal.  
   
   
       54 . The method of  claim 51 , 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.  
   
   
       55 . A method of treating glaucoma in a patient in need thereof comprising: 
 delivering into an eye of a patient an implantable surgical implant having an inlet section positioned in the anterior chamber and a distal section positioned in Schlemm's canal to facilitate flow of aqueous humor from the anterior chamber into Schlemm's canal;    conducting aqueous humor along the surgical implant to reduce intraocular pressure in the eye; and    providing at least one medication to the eye of the patient.    
   
   
       56 . The method of  claim 55 , wherein the implant comprises a unidirectional valve.  
   
   
       57 . The method of  claim 55 , wherein at least a portion of the implant comprises a solid material.  
   
   
       58 . The method of  claim 57 , wherein the solid material is porous.  
   
   
       59 . The method of  claim 57 , wherein the implant comprises a V-shape.  
   
   
       60 . The method of  claim 57 , wherein the implant 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.  
   
   
       61 . The method of  claim 55 , wherein a portion of the implant for insertion into Schlemm's canal comprises a solid material.  
   
   
       62 . The method of  claim 55 , wherein a portion of the implant for insertion within the anterior chamber comprises a solid material.  
   
   
       63 . The method of  claim 55 , wherein the implant 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.  
   
   
       64 . The method of  claim 55 , wherein the implant comprises a V-shape.  
   
   
       65 . The method of  claim 64 , wherein the aqueous humor is drained unidirectionally within Schlemm's canal.  
   
   
       66 . The method of  claim 64 , wherein the portion for insertion within Schlemm's canal comprises a lumen therethrough that directs the passage of fluid into Schlemm's canal.  
   
   
       67 . The method of  claim 64 , wherein the portion for insertion within the anterior chamber has a lumen therethrough that facilitates the passage of fluid into the portion of the device that is inserted within Schlemm's canal.  
   
   
       68 . The method of  claim 64 , wherein the portion for insertion within the anterior chamber has two lumens therethrough that facilitate the passage of fluid into a portion of the device that is inserted within Schlemm's canal.