Shunt and Method Treatment of Glaucoma

• US 20090036818A1
• Filed: 08/12/2008
• Published: 02/05/2009
• Est. Priority Date: 05/29/2002
• Status: Active Grant

• Current Assignee: University Of Saskatchewan
• Original Assignee: University Of Saskatchewan
• Inventors: Stilling, Denise Sharon, Grahn, Bruce Harold, Storey, Eric Shad
• Granted Patent: US 7,947,008 B2
• Time in Patent Office: Days
• US Class Current: 604/8
• CPC Class Codes: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts
• CPC Class Codes: A61F 9/00781 Apparatus for modifying intraocular pressure, e.g. for glaucoma treatment drainage implants in general A61M27/002
• CPC Class Codes: A61M 2210/0612 Eyes
• CPC Class Codes: A61M 27/002 Implant devices for drainage of body fluids from one part of the body to another intraocular A61F9/00781; middle ear A61F11/202
• CPC Class Codes: A61M 39/22 Valves or arrangement of valves A61M39/02, A61M39/0247, A61M39/16 take precedence; regulating valves in infusion systems A61M5/16881; in devices worn by the patient for the reception of urine, faeces, catamenial or other discharge, or in colostomy devices A61F5/4405

Abstract

This invention provides a shunt for implantation between the anterior chamber of the eye and the epithelial-lined space through the frontal sinus bone of a patient for the treatment of glaucoma. The shunt includes a tube having a length sufficient to span the distance between the anterior chamber of the eye and the epithelial-lined space of the patient, the tube having an open anterior chamber end and a closed epithelial-lined space end, and a seal device associated with the tube between the anterior chamber and epithelial-lined space ends, for sealing a hole in the frontal sinus bone, and for anchoring the tube against movement from the frontal sinus bone. The shunt also includes a fluid pressure openable valve in the tube, located at or near the epithelial-lined space sinus end, allowing for controlled flow of aqueous humor through the tube when implanted. The invention also extends to a method of treating glaucoma in a patient by surgically implanting the shunt between the anterior chamber of the eye and the frontal sinus.

Claims

1. A shunt for implantation between the anterior chamber of the eye and an epithelial-lined space of a patient for the treatment of glaucoma, comprising:

a tube having a length sufficient to span the distance between the anterior chamber of the eye and the epithelial-lined space of the patient, the tube having an open anterior chamber end and an epithelial-lined space end;

a seal device associated with the tube between the anterior chamber and epithelial-lined space ends to seal and anchor the tube against movement once implanted; and

an adjustable valve in the tube to control flow of aqueous humor through the tube when implanted.

2. The shunt of claim 1, wherein the valve is adjustable to open and close to maintain a desired intraocular pressure for the patient.

3. The shunt of claim 2, wherein the tube has a length sufficient to span the distance between the anterior chamber and the epithelial-lined space selected from the maxillary sinus, nasal sinus, respiratory sinus or space, subdural space or meningeal cavity.

4. The shunt of claim 3, wherein the valve is located at or near the epithelial-lined space end of the tube.

5. The shunt of claim 4, wherein the epithelial-lined space is the frontal sinus, and the epithelial-lined space end of the tube is thus the frontal sinus end.

6. The shunt of claim 4, wherein the valve is fluid pressure openable.

7. The shunt of claim 5, wherein the frontal sinus end of the tube is closed and wherein the valve comprises a longitudinal slit in the tube, and one or more ligature devices around the tube overlying or adjacent the slit such that adjustment of the one or more ligature devices adjusts fluid flow through the valve.

8. The shunt of claim 5, wherein the shunt further comprises a reservoir located at the frontal sinus end of the tube, said reservoir having a side wall forming one or more apertures through which fluid can flow from the tube, and wherein the valve is located in the reservoir.

9. The shunt of claim 8, wherein the valve comprises a pair of spaced apart discs connected together by a spring member, the disc facing the anterior chamber end being apertured to allow the valve to open with a predetermined fluid flow pressure from the anterior chamber end.

10. The shunt of claim 9, wherein the valve is a tapered nipple type valve.

11. The shunt of claim 9, wherein the valve is a butterfly type valve.

12. The shunt of claim 5, wherein the seal device comprises a widened portion of the tube, or a pliable spool-shaped plug fixed to the tube and through which the tube is threaded, said plug having upper and lower pliable flanges which seal on either side of a hole in the frontal sinus bone and which prevent movement of the plug relative to the frontal sinus bone, the upper flange being anterior chamber facing and being sufficiently pliable to be slid through the hole in the frontal sinus bone.

13. The shunt of claim 12, wherein the seal device or the plug bends the tube through an angle sufficient to prevent kinking of the tube as it is implanted between the anterior chamber and the frontal sinus.

14. The shunt of claim 12, wherein the seal device or the plug bends the tube through an angle of between 80 and 100°

.

15. A method of treating glaucoma in a patient, comprising:

forming a hole from the exterior into the epithelial-lined space of the patient;

surgically implanting through the hole, between the anterior chamber and the epithelial-lined space, a shunt as defined in claim 1; and

draining aqueous humor from the anterior chamber through the shunt to the epithelial-lined space.

16. The method of claim 15, wherein the valve is adjustable to open or close to maintain a desired intraocular pressure for the patient.

17. The method of claim 16, wherein the tube has a length sufficient to span the distance between the anterior chamber and the epithelial-lined space selected from the maxillary sinus, nasal sinus, respiratory sinus or space, subdural space or meningeal cavity, and wherein the shunt is implanted between the anterior chamber and the selected epithelial-lined space.

18. The method of claim 17, wherein the valve is located at or near the epithelial-lined space end of the tube.

19. The method of claim 18, wherein the epithelial-lined space is the frontal sinus, wherein the hole is formed in the frontal sinus bone, and wherein the epithelial-lined space end is the frontal sinus end.

20. The method of claim 18, wherein the valve is fluid pressure openable.

21. The method of claim 19, wherein the frontal sinus end of the valve is closed, and wherein the valve comprises a longitudinal slit in the tube, and one or more ligature devices around the tube overlying or adjacent the slit such that adjustment of the one or more ligature devices adjusts fluid flow through the valve.

22. The method of claim 19, wherein the shunt further comprises a reservoir located at the frontal sinus end of the tube, said reservoir having a side wall forming one or more apertures through which fluid can flow from the tube, and wherein the valve is located in the reservoir.

23. The method of claim 22, wherein the valve comprises a pair of spaced apart discs connected together by a spring member, the disc facing the anterior chamber end being apertured to allow the valve to open with a predetermined fluid flow pressure associated with glaucoma from the anterior chamber end.

24. The method of claim 22, wherein the valve is a tapered nipple type valve.

25. The method of claim 22, wherein the valve is a butterfly type valve.

26. The method of claim 19, wherein the seal device is located to seal the hole in the frontal sinus bone through which the tube is inserted, and to anchor the tube against movement from the frontal sinus bone.

27. The method of claim 26, wherein said seal device comprises a widened portion of the tube, or a pliable spool shaped plug fixed to the tube and through which the tube is threaded, said plug having upper and lower pliable flanges which seal on either side of the hole in the frontal sinus bone and which prevent movement of the plug relative to the frontal sinus bone, the upper flange being anterior chamber facing and being sufficiently pliable to be slid through the hole in the frontal sinus bone.

28. The method of claim 27, wherein the seal device or plug bends the tube through an angle sufficient to prevent kinking of the tube as it is implanted between the anterior chamber and the frontal sinus.

29. The method of claim 27, wherein the seal device or plug bends the tube through an angle of between 80 and 100°

.

30. A shunt for implantation between the anterior chamber of the eye and the frontal sinus of a patient for the treatment of glaucoma, comprising:

a tube having a length sufficient to span the distance between the anterior chamber of the eye and the frontal sinus of the patient, the tube having a tube end and a valved frontal sinus end;

a seal component on the tube spaced from the frontal sinus end to hold the tube in place in the frontal sinus;

a slit extending longitudinally in the tube and located at the frontal sinus end, allowing for flow of aqueous humor through the tube when implanted; and

one or more sutures around the tube near the slit to control flow through the slit.

31. The shunt of claim 30, wherein the seal component bends the tube to prevent kinking of the tube as it is implanted between the anterior chamber and the frontal sinus.

32. The shunt of claim 31, wherein the tube is formed of silicone.

33. The shunt of claim 32, wherein the tube has an internal diameter of approximately 0.3 mm.