Uveoscleral shunt and methods for implanting same

• US 8,506,515 B2
• Filed: 11/09/2007
• Issued: 08/13/2013
• Est. Priority Date: 11/10/2006
• Status: Active Grant

• Current Assignee: Glaukos Corporation
• Original Assignee: Glaukos Corporation
• Inventors: Burns, Thomas W., Haffner, David, Heitzmann, Harold A., Fjield, Todd N., Hill, Richard A.
• Primary Examiner(s): Wiest, Philip R
• Application Number:
  US11/938,238
• Publication Number:
  US 20080228127A1
• Time in Patent Office: 2,104 Days
• Field of Search: 604 8- 10, 604 15- 18, 604/29, 604/49, 604/104, 604/164, 604/175, 604/264, 604/272, 604/274, 604/280, 604/294, 604/284, 606107-108, 623/4.1
• US Class Current: 604/8
• 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: A61P 27/06 Antiglaucoma agents or miotics

Abstract

Devices and methods for treating intraocular pressure are disclosed. The devices include shunts for draining aqueous humor from the anterior chamber to the uveoscleral outflow pathway, including the supraciliary space and the suprachoroidal space. The shunts are preferably implanted by ab interno procedures.

Claims

1. A system for treating an ocular disorder in a patient, comprising:

a drainage implant which, following implantation at an implantation site, conducts fluid from the anterior chamber to a uveoscleral outflow pathway of an eye; and

a delivery instrument for implanting the drainage implant, said instrument having a distal end sufficiently sharp to penetrate eye tissue at an insertion site near the limbus of the patient'"'"'s eye, and being sufficiently long to advance the implant transoccularly from the insertion site across the anterior chamber to the implantation site, wherein at least the distal end of the delivery instrument is flexible, a distal end portion having a non-linear shape, said instrument having a sufficiently small cross section such that the insertion site self seals without suturing upon withdrawal of the instrument from the eye, said instrument being comprised of plural members longitudinally moveable relative to each other and a seal between said members to prevent aqueous humor from passing between the members proximal the seal when the instrument is in the eye,

wherein the seal is integral with one of the plural members.

2. The system of claim 1, wherein an outer diameter of the delivery instrument is not greater than about 18 gauge and is not smaller than about 21 gauge.

3. The system of claim 1, wherein the plural members of the delivery instrument comprises an outer incision member and an inner implantation member that interacts with the implant.

4. The system of claim 3, wherein the inner implantation member comprises a flexible trocar that passes through the implant.

5. The system of claim 3, wherein the implantation member is less than 20 gauge yet larger than 27 gauge.

6. The system of claim 3, wherein the seal is between at least portions of the incision member and the implantation member.

7. The system of claim 6, wherein the seal comprises a coating present on at least one of the incision and implantation members.

8. The system of claim 7, wherein the coating comprises a hydrophobic coating.

9. The system of claim 7, wherein the coating comprises a hydrophilic coating.

10. The system of claim 7, wherein the coating comprises a silicone coating.

11. The system of claim 6, wherein the seal is entirely disposed proximate of the drainage implant when carried by the delivery instrument.

12. The system of claim 1, wherein the delivery instrument includes a distal end having a beveled shape.

13. The system of claim 1, wherein the delivery instrument includes a distal end having a spatula shape with a sharpened edge.

14. The system of claim 1, wherein the drainage implant has a distal end that is sufficiently sharp to pierce eye tissue near the scleral spur of the eye.

15. The system of claim 1, wherein the drainage implant includes at least one lumen extending between an inlet, which is disposed within the anterior chamber once implanted, and an outlet, which is disposed within the physiologic outflow path once implanted.

16. The system of claim 15, wherein the drainage implant additionally includes a flow regulator to control fluid flow through the at least one lumen.

17. The system of claim 16, wherein the flow regulator includes a pressure relief valve that opens when fluid pressure within the anterior chamber exceeds a preset level.

18. The system of claim 17, wherein the pressure relief valve comprises a ball, a ball seat and a biasing member urging the ball towards the ball seat.

19. The system of claim 15, wherein at least a portion of the at least one lumen has a sufficiently small cross-sectional area along a sufficiently long length to restrict fluid flow through said lumen to a rate not to exceed about 5 μ

l/min.

20. The system of claim 15, wherein the portion of the at least one lumen has a sufficiently small cross-sectional area along a sufficiently long length to restrict fluid flow through said lumen to a rate not to exceed about 2.5 μ

l/min.

21. The system of claim 1, wherein the drainage implant has a cylindrical body.

22. The system of claim 1, wherein the drainage implant has a length between an inlet portion and an outlet portion ranging between about 1 mm and 3 mm.

23. The system of claim 1, wherein the drainage implant has an overall length not greater than 5 mm.

24. The system of claim 1, wherein the drainage implant has sufficient length between an inlet portion and an outlet portion such that, following implantation, the inlet portion is disposed within the anterior chamber and the outlet portion is disposed with the uveoscleral outflow pathway.

25. The system of claim 1, wherein the distal end portion of the delivery instrument is curved.

26. The system of claim 1, wherein the distal end portion of the delivery instrument is angled.