GLAUCOMA DRAINAGE DEVICE AND USES THEREOF

• US 20120089073A1
• Filed: 10/12/2011
• Published: 04/12/2012
• Est. Priority Date: 10/12/2010
• Status: Active Grant

• Current Assignee: Emmett T. Cunningham Jr
• Original Assignee: Emmett T. Cunningham Jr
• Inventors: Cunningham, Emmett T. Jr.
• Granted Patent: US 8,915,877 B2
• Time in Patent Office: Days
• US Class Current: 604/9
• 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: B82Y 5/00 Nanobiotechnology or nanomedicine, e.g. protein engineering or drug delivery

Abstract

In one aspect, the present invention provides an implant device for use in an eye with elevated intraocular pressure or glaucoma. In another aspect, the present invention provides a method for lowering intraocular pressure and/or treating a condition associated with elevated intraocular pressure using the implant device of the present invention.

Claims

1. A device for use in an eye with elevated intraocular pressure or glaucoma, the device comprising:

a. a tubular body portion having one or more lumens adapted and configured for diverting intraocular fluid from the vitreous cavity to the subconjunctival space at the pars plana;

b. the tubular body portion terminating on one end at an inlet section and on another end at an outlet section, the tubular body portion being sized and shaped such that the inlet section is in close apposition to intraocular surface at the pars plana and the outlet section rests on the sclera at the pars plana;

c. the inlet section adapted and configured for fluid communication with the outlet section via one or more lumens;

d. the inlet section adapted and configured to fit in apposition to the intraocular surface in the vitreous body at the pars plana so as to prevent dislocation or migration; and

e. the outlet section adapted and configured to fit in apposition to the surface of the sclera at the pars plana so as to prevent dislocation or migration.

2. The device of claim 1, wherein the tubular body portion has an 18 gauge or less external size.

3. The device of claim 1, wherein the tubular body portion is adapted and configured for placement in isolation at the pars plana to provide for direct intraocular fluid flow from the vitreous cavity to the subconjunctival space.

4. The device of claim 1, wherein the tubular body portion is adapted and configured for placement in direct or indirect connection with one or more devices in the subconjunctival space that are intended to enhance and/or direct intraocular fluid flow from the vitreous cavity to the subconjunctival space.

5. The device of claim 1, wherein each of the lumens is selectively controllable between an open and a closed position.

6. The device of claim 1, wherein each of the lumens comprises a flow regulating member.

7. The device of claim 6, wherein the flow regulating member is selected from the group consisting of a plurality of nanotubes, a plurality of capillary tubes, a plurality of collimated passages and combinations thereof.

8. The device of claim 6, wherein the flow regulating member comprises a biological mechanoprotein used to regulate fluid flow.

9. The device of claim 6, wherein the flow regulating member is a membrane.

10. The device of claim 6, wherein the flow regulating member is a micromechanical valve.

11. The device of claim 1, wherein each of the lumen is reclosably openable.

12. The device of claim 1, wherein each of the lumen is initially closed and irreversibly openable.

13. The device of claim 12, wherein the irreversibly openable lumen comprises a soluble barrier that is initially non-patent and over time due to the time-dependent erosion, dissolution or decomposition of the soluble barrier becomes patent.

14. The device of claim 12, wherein the irreversibly openable lumen comprises a barrier such as a membrane or plug that is initially non-patent and selectively opened using an external laser.

15. The device of claim 12, wherein the irreversibly openable lumen comprises a barrier such as a membrane or plug that is initially non-patent and selectively opened using an external mechanical probe.

16. The device of claim 1, wherein each of the lumens has a size that is different from the other lumen.

17. The device of claim 16, wherein the size is between about 20 and 50 gauge.

18. The device of claim 1, wherein each of the lumens is labeled so as to be differentiated from the other lumen.

19. The device of claim 18, wherein the lumen is labeled by color.

20. The device of claim 1, wherein the inlet section comprises a structure adapted and configured for minimizing clogging of the fluid communication at the inlet section by formed vitreous, blood, intraocular tissues, or scar formation.

21. The device of claim 20, wherein the structure for minimizing clogging is selected from the group consisting of a filter membrane, surface corrugations, a surrounded cage structure, surface ridges, multiple ports, multiple perforations, anti-clogging shaped structure, and combinations thereof.

22. The device of claim 21, wherein the anti-clogging shaped structure comprises a shape selected from the group consisting of a spiral, a screw, a helix, and combinations thereof

23. The device of claim 1, wherein the outlet section comprises a flange-like structure that is larger than the tubular body portion and the flange-like structure is adapted and configured to fit on the surface of the sclera at the pars plana so as to prevent the implant from dislocating or migrating.

24. The device of claim 1, wherein the inlet section comprises a flange-like structure that is larger than the tubular body portion and the flange-like structure is adapted and configured to fit on the intraocular surface at the pars plana so as to prevent the implant from dislocating or migrating.

25. The device of claim 1, wherein a portion of the external surface of the tubular body portion comprises a securing structure adapted and configured for securing the device in place near the pars plana.

26. The device of claim 25, wherein the securing structure is selected from the group consisting of a tissue adhesive, one or more barbs, a threading mechanism, a structure for suture placement, and combinations thereof.

27. The device of claim 1, wherein the device is made of a biocompatible material selected from the group consisting of titanium, stainless steel, silicone, polyurethane, ploylactic acid, polyvinyl alcohol, polyvinyl pyrolidone, collagen, heparinized collagen, polytetrafluoroethylene, expanded polytetrafluoroethylene, fluorinated polymer, fluorinated elastomer, flexible fused silica, polyolefin, polyester, polysilicon, polyamide, parylene, and combinations thereof.

28. The device of claim 1, wherein the device has a drug-eluting coating.

29. The device of claim 28, wherein the drug-eluting coating comprises an anti-inflammatory agent.

30. The device of claim 29, wherein the anti-inflammatory agent is selected from the group consisting of corticosteroids, immunosuppressive agents, non-steroidal anti-inflammatory drugs, anti-inflammatory proteins, peptides, or nucleic acids, and combinations thereof.

31. The device of claim 28, wherein the drug-eluting coating comprises an anti-proliferative agent.

32. The device of claim 31, wherein the anti-proliferative is selected from the group consisting of consisting of a corticosteroid, an immunosuppressive agent, mitomycin, 5-fluorouracil, heparin, anti-proliferative proteins, peptides, or nucleic acids and combinations thereof.

33. The device of claim 28, wherein the drug-eluting coating comprises an anti-microbial agent.

34. The device of claim 28, wherein the drug-eluting coating comprises an intraocular pressure lowering agent.

35. The device of claim 28, wherein the drug-eluting coating comprises a vitreolytic agent.

36. The device of claim 35, wherein the vitreolytic agent is selected from the group consisting of a dispase, urea, collagenase, hyaluronidase, plasmin, microplasmin, chondroitinase, a protease, and combinations thereof.

37. A method for lowering intraocular pressure, comprising introducing into an eye a device of claim 1, and diverting intraocular fluid from vitreous cavity to subconjunctival space at pars plana.

38. The method of claim 37, wherein the device is a self-contained transmural shunt device.

39. The method of claim 37, wherein the device resides entirely within the pars plana.

40. The method of claim 37, further comprising an eye surgery trabeculectomy.