System and method for treating glaucoma

• US 20060036207A1
• Filed: 08/23/2005
• Published: 02/16/2006
• Est. Priority Date: 02/24/2004
• Status: Abandoned Application

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Sniegowski, Jeffry J., Rodgers, M. Steven, McWhorter, Paul J., Barnes, Stephen M., Smith, Norman F., Koonmen, James P.
• Application Number:
  US11/209,357
• Publication Number:
  US 20060036207A1
• Time in Patent Office: Days
• 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: B82Y 30/00 Nanotechnology for materials or surface science, e.g. nanocomposites

Abstract

An integral conduit (407) in the formed of stepped tubing defines at least part of a drainage flow path (408/408′) that accommodates a flow rate of at least about 0.15 microliters/minute/mm²/mm-Hg out of the anterior chamber (284) of the eye (266). One or more flow modules (415) may be disposed within this drainage flow path (408/048′) and are located exteriorly of the eye (266). Each flow module (415) may be in the form of a filter or a pressure regulator. In one embodiment, one flow module (415) in the form of a filter is used in combination with another flow module (415) in the form of a pressure regulator.

Claims

1. A method for addressing intraocular pressure within an eye, comprising the step of:

providing a drainage flow path from an anterior chamber of an eye to a first drainage location, wherein said drainage flow path allows a flow of at least about 0.15 microliters/minute/mm²/mm-Hg through said drainage flow path.

2. The method of claim 1, wherein said first drainage location is exteriorly of the eye.

3. The method of claim 1, wherein said providing step comprises directing a first conduit section of a conduit through said eye and into said anterior chamber, wherein an entirety of a second conduit section of said conduit is disposed exteriorly of said eye, and wherein said first conduit section comprises a first cross-sectional profile taken perpendicularly to a length dimension of said first conduit section that is smaller than a second cross-sectional profile of said second conduit section taken perpendicularly to a length dimension of said second conduit section.

4. The method of claim 3, wherein a flow module is disposed within said second conduit section.

5. The method of claim 4, wherein said flow module is selected from the group consisting of a filter, a pressure regulator, and a device comprising filter and pressure regulator sections.

6. The method of claim 4, further comprising step of replacing said flow module, wherein said replacing step comprises expanding at least a portion of said second conduit section.

7. The method of claim 3, wherein first and second flow modules are disposed within said second conduit section.

8. The method of claim 7, wherein said first flow module is a filter and wherein said second flow module is a pressure regulator.

9. The method of claim 7, wherein said first flow module allows an at least substantially linear increase in a flow through said first flow module in response to an increase in a differential pressure across said first flow module, and wherein said second flow module allows greater than a linear increase in a flow through said second flow module in response to an increase in a differential pressure across said second flow module.

10. The method of claim 7, wherein said first and second flow modules are disposed in series within said second conduit section.

11. The method of claim 3, wherein said second conduit section is entirely disposed within a conjunctival cul-de-sac.

12. The method of claim 3, wherein said first and second conduit sections are integrally formed.

13. The method of claim 12, wherein a flow module is disposed within said second conduit section.

14. The method of claim 13, further comprising step of replacing said flow module, wherein said replacing step comprises expanding at least a portion of said second conduit section.

15. The method of claim 12, wherein a third conduit section is interconnected with said second conduit section by a coupling, and wherein a flow module is disposed within said third conduit section.

16. The method of claim 15, wherein an outer wall of said coupling comprises first and second protuberances, wherein said second conduit section is disposed over said first protuberance and wherein said third conduit section is disposed over said second protuberance.

17. The method of claim 15, further comprising the step of replacing said flow module, wherein said replacing step comprises disconnecting at least one of said coupling from said second conduit section and disconnecting said third conduit section from said coupling, wherein said flow module remains within said third conduit section during said replacing step.

18. The method of claim 3, wherein a third conduit section is interconnected with said second conduit section by a coupling, and wherein a flow module is disposed within said third conduit section.

19. The method of claim 18, further comprising the step of replacing said flow module, wherein said replacing step comprises disconnecting at least one of said coupling from said second conduit section and disconnecting said third conduit section from said coupling, wherein said flow module remains within said third conduit section during said replacing step.

20. The method of claim 3, wherein said first and second conduit sections each comprise a cylindrical outer wall.

21. The method of claim 1, wherein said providing step comprises directing a conduit through said eye and into said anterior chamber.

22. The method of claim 21, further comprising the step of applying an anti-bacterial material to said eye before said directing step.

23. The method of claim 21, wherein at least a portion of an exterior of said conduit promotes adhesion with adjoining biological tissue.

24. The method of claim 23, wherein said biological tissue is selected from the group consisting of the conjunctiva and the sclera of said eye.

25. The method of claim 21, wherein a first end of said conduit is disposed within said anterior chamber and a second end of said conduit is disposed within a conjunctival cul-de-sac.

26. The method of claim 21, wherein a flow module is disposed within said conduit.

27. The method of claim 26, wherein said flow module is selected from the group consisting of a filter, a pressure regulator, and a device comprising filter and pressure regulator sections.

28. The method of claim 26, wherein said flow module comprises at least one hydrophilic surface.

29. The method of claim 26, wherein said flow module comprises means for reducing the ability of biological material to attach to said flow module.

30. The method of claim 26, wherein at least one surface of said flow module that is exposed to a fluid within said drainage flow path comprises a self-assembled monolayer coating.

31. The method of claim 26, wherein said flow module accommodates greater than a linear increase in a flow through said flow module in response to an increase in a differential pressure across said flow module.

32. The method of claim 26, wherein said flow module accommodates at least a substantially linear increase in a flow through said flow module in response to an increase in a differential pressure across said flow module.

33. The method of claim 26, wherein each flow path through said flow module is of an at least substantially fixed dimension.

34. The method claim 26, wherein said flow module comprises at least one element that moves in response to a change in a differential pressure to which said at least one element is exposed.

35. The method of claim 26, further comprising the step of at least substantially occluding said conduit and thereafter replacing said flow module.

36. The method of claim 35, further comprising the steps of applying an anti-bacterial material to said eye before said replacing step.

37. The method of claim 35, wherein a first portion of said conduit is disposed within said eye and a second portion of said conduit is disposed exteriorly of said eye, wherein said flow module is disposed within said second portion of said conduit, and wherein said replacing step is executed without removing said first portion of said conduit from said eye.

38. The method of claim 26, wherein a first portion of said conduit is disposed within said eye and a second portion of said conduit is disposed exteriorly of said eye, wherein said flow module is disposed within said second portion of said conduit, and wherein said method further comprises the step of replacing said flow module without removing said first portion of said conduit from said eye.

39. The method of claim 38, further comprising the step of at least substantially occluding said conduit before said replacing step.

40. The method of claim 38, further comprising the step of applying an anti-bacterial material to said eye before said replacing step.

41. The method of claim 21, wherein first and second flow modules are disposed within said conduit.

42. The method of claim 41, wherein said first flow module is a filter in wherein said second flow module is a pressure regulator.

43. The method of claim 41, wherein said first flow module accommodates at least a substantially linear increase in a flow through said first flow module in response to an increase in a differential pressure across said first flow module, and wherein said second flow module accommodates greater than a linear increase in a flow through said second flow module in response to an increase in a differential pressure across said second flow module.

44. The method of claim 41, wherein said first and second flow modules are disposed in series within said conduit.

45. The method of claim 1, wherein said drainage flow path allows a flow of at least about 0.30 microliters/minute/mm²/mm-Hg through said drainage flow path.

46. The method of claim 1, wherein said drainage flow path allows a flow of at least about 0.6 microliters/minute/mm²/mm-Hg through said drainage flow path.

47. The method of claim 1, wherein said drainage flow path allows a flow of at least about 1.2 microliters/minute/mm²/mm-Hg through said drainage flow path.

48. The method of claim 1, wherein said drainage flow path allows a flow of about 1.5 microliters/minute/mm²/mm-Hg through said drainage flow path.

49. The method of claim 1, wherein said drainage flow path comprises a first region, wherein said first region is located outside of said anterior chamber of said eye, and wherein said first region is configured to retain particles having a minimum dimension of at least about 0.4 microns.

50. The method of claim 1, wherein said drainage flow path comprises a first region, wherein said first region is located outside of said anterior chamber of said eye, and wherein said first region is configured to retain particles having a minimum dimension of at least about 0.3 microns.

51. The method of claim 1, wherein said drainage flow path comprises a first region, wherein said first region is located outside of said anterior chamber of said eye, and wherein said first region is configured to retain particles having a minimum dimension of at least about 0.2 microns.

52. The method of claim 1, wherein said drainage flow path comprises a first region, wherein said first region is located outside of said anterior chamber of said eye, and wherein said first region is configured to retain particles having a minimum dimension of at least about 0.1 microns.

53. The method of claim 1, wherein said drainage flow path comprises a first region, wherein said first region is configured to retain pseudomonas aeruginosa.

54. The method of claim 1, wherein said drainage flow path comprises a first region, wherein said first region is configured to retain staphylococcus aureus.

55. The method of claim 1, wherein said drainage flow path comprises a first region, wherein said first region is configured to retain brevundimonas diminuta.

56. A method for addressing intraocular pressure within an eye, comprising the steps of:

occluding a portion of a conduit that extends from an anterior chamber of an eye to a first drainage location; and

replacing a flow module disposed within said conduit after said occluding step.

57. A system for addressing intraocular pressure within an eye, comprising:

a conduit comprising a drainage flow path, wherein a first end of said conduit is directed through the eye to fluidly interface with the anterior chamber of the eye when said system is installed, and wherein a second end of said conduit is disposed outside of the anterior chamber when said system is installed; and

means for allowing a flow of at least about 0.15 microliters/minute/mm²/mm-Hg out of said anterior chamber through said drainage flow path.

58. A system for addressing intraocular pressure within an eye, comprising:

a conduit comprising a drainage flow path;

a first flow module disposed within said drainage flow path; and

a second flow module disposed within said drainage flow path.

59. A system for addressing intraocular pressure within an eye, comprising:

an integral first conduit comprising a drainage flow path, wherein said first conduit comprises first and second conduit sections, wherein said first conduit section comprises a first cross-sectional profile taken perpendicularly to a length dimension of said first conduit section that is smaller than a second cross-sectional profile of said second conduit section taken perpendicularly to a length dimension of said second conduit section, wherein an end of said first conduit section is directed through the eye when said system is installed, and wherein an entirety of said second conduit is disposed exteriorly of the eye when said system is installed.

60. A system for addressing intraocular pressure within an eye, comprising:

a conduit comprising a drainage flow path, wherein a first end of said conduit is directed through the eye to fluidly interface with the anterior chamber of the eye when said system is installed, and wherein a second end of said conduit is disposed outside of the anterior chamber when said system is installed;

a MEMS flow module disposed within said conduit, wherein said MEMS flow module comprises a plurality of gaps through which a flow may progress, wherein a size of a largest of said plurality of gaps is no more than about 105% of a size of a smallest of said plurality of gaps.

61. A method for reducing intraocular pressure in an eye, said method comprising providing a drainage path from an anterior chamber to an external location, wherein the drainage path allows the outflow of aqueous fluid at a rate of at least 1.5 microliters/minute in response to an ocular pressure of 10 mm-Hg or higher while preventing the intrusion of substantially all bacteria having a dimension of 0.35 micrometer or larger.

62. The method of claim 61, wherein the drainage path has a cross-sectional area no greater than 1 mm².

63. The method of claim 61, wherein a filter is disposed within the drainage path.

64. A method for treating glaucoma, said method comprising draining aqueous fluid at a rate of at least 1.5 microliters/minute whenever an intraocular pressure exceeds 10 mm-Hg while substantially completely excluding the intrusion of Pseudomonas aeruginosa and larger bacteria.

65. A system for reducing intraocular pressure in an eye, said system comprising:

a conduit structure adapted to be implanted from an anterior chamber of an eye to a location external of the eye; and

a filter structure in the conduit structure, said filter structure allowing the outflow of aqueous fluid at a rate of at least 1.5 microliters/minute in response to an ocular pressure of 10 mm-Hg or higher while preventing the intrusion of substantially all bacteria having a dimension of 0.35 micrometer or larger.

66. The system of claim 65, wherein a flow path through the conduit structure has a cross-sectional area no greater than 1 mm².