Selectable varied control valve systems for IOP control systems

• US 9,072,588 B2
• Filed: 10/03/2011
• Issued: 07/07/2015
• Est. Priority Date: 10/03/2011
• Status: Active Grant

• Current Assignee: Alcon Incorporated
• Original Assignee: Alcon Research Limited (Nestle SA)
• Inventors: Bhm, Sebastian, Field, Leslie A.
• Primary Examiner(s): Ho, Tan-Uyen (Jackie) T
• Assistant Examiner(s): WARDAS, MARK A
• Application Number:
  US13/251,368
• Publication Number:
  US 20130085440A1
• Time in Patent Office: 1,373 Days
• Field of Search: 604 8- 10, 604/93.01, 604/104, 604/171, 604/246, 604/514, 604/521, 604/19, 604/21, 604/294, 604/298, 604/890.1, 604/891.1, 604/892.1, 604/30, 604/99.02, 424/427, 128/887, 128/898
• US Class Current: 1/1
• CPC Class Codes: A61F 9/00781 Apparatus for modifying intraocular pressure, e.g. for glaucoma treatment drainage implants in general A61M27/002

Abstract

A selectable IOP valve for implantation in an eye of a patient controls IOP and/or bleb pressure. The valve includes a drainage tube configured to convey aqueous from an anterior chamber of an eye and includes a selectable flow control valve in fluid communication with the drainage tube and configured to control flow rates of the aqueous. The valve system includes a plurality of flow control pathways arranged to operate in parallel with each other, each of the flow control pathways being in communication with an entry port to the valve system. A flow control mechanism controls aqueous flow through the pathways. Methods and systems are also disclosed.

Claims

1. A selectable IOP valve for implantation in an eye of a patient, comprising:

a flow control valve system configured to control flow rates of aqueous, the valve system comprising;

a plurality of flow control pathways arranged to operate in parallel with each other, each of the flow control pathways being in communication with an entry port to the valve system,

a flow control mechanism associated with each of the plurality of flow control pathways, the flow control mechanism being arranged to selectively control aqueous flow rates through the flow control pathways, and

a flexible membrane, wherein the flexible membrane is selectively actuatable by the flow control mechanism to occlude at least one of the plurality of flow control pathways to selectively increase or decrease the flow rate of the aqueous through the flow control valve system.

2. The IOP valve of claim 1, further comprising a drainage tube in fluid communication with the flow control valve system, the drainage tube being configured to convey aqueous from an anterior chamber of an eye.

3. The IOP valve of claim 1, wherein the flexible membrane is actuatable in response to pressure differentials.

4. The IOP valve of claim 3, wherein the flow control mechanism comprises a separate flow control mechanism associated with each of the plurality of flow control pathways.

5. The IOP valve of claim 4, further comprising a check valve disposed in at least one of the plurality of flow control pathways.

6. The IOP valve of claim 4, further comprising a check valve disposed in each of the plurality of flow control pathways.

7. The IOP valve of claim 1, wherein the flow control mechanism comprises a single flow control mechanism associated with multiple flow control pathways of the plurality of flow control pathways.

8. The IOP valve of claim 1, wherein the flow control mechanism comprises a separate flow control mechanism associated with each flow control pathway of the plurality of flow control pathways, each of the separate flow control mechanisms comprising a membrane valve.

9. The IOP valve of claim 8, wherein the membrane valve is biased closed to restrict flow through the flow control pathway until an aqueous pressure exceeds the biasing force.

10. The IOP valve of claim 9, wherein the membrane valve actuates in response to a pressure differential from at least two pressures present in the eye.

11. The IOP valve of claim 10, wherein the at least two pressures include the pressure in an anterior chamber, a drainage location, or atmospheric pressure.

12. The IOP valve of claim 11, wherein at least one pressure approximates atmospheric pressure via fluidic communication with a subconjunctival space of the eye.

13. The IOP valve of claim 1, wherein the flow control mechanism comprises a first membrane and a second membrane associated with at least one of the plurality of flow control pathways.

14. The IOP valve of claim 1, wherein each flow control pathway of the plurality of flow control pathways is arranged to provide a different resistance to aqueous flow.

15. The IOP valve of claim 14, comprising a controller configured to adjust the flow control mechanism to change the amount of flow through each of the plurality of flow control pathways and achieve a desired overall flow rate.

16. The IOP valve of claim 1, wherein the flow control mechanism comprises an actuator fluid and bubble generating system configured to generate bubbles by converting at least a portion of the actuator fluid to a gas.

17. The IOP valve of claim 16, wherein the bubble generating system comprises at least two electrodes.

18. The IOP valve of claim 1, further comprising:

a power source coupled to the flow control valve system; and

a processor configured to control the flow control valve system to increase and decrease permitted aqueous flow through the valve.

19. The IOP valve of claim 1, further comprising:

a first pressure sensor located in fluid communication with the anterior chamber of an eye; and

a second pressure sensor located in a drainage location;

wherein a difference between readings from the first pressure sensor and the second pressure sensor approximates a pressure differential between the anterior chamber and the drainage location.

20. The IOP valve of claim 19, wherein readings from the first pressure sensor and the second pressure sensor are used to control the flow control mechanism to modify aqueous flow through the valve.

21. The IOP valve of claim 1, further comprising:

a first pressure sensor located in fluid communication with the anterior chamber of an eye; and

a remote pressure sensor located remotely from the first pressure sensor such that the remote pressure sensor measures or approximates atmospheric pressure,

wherein a difference between readings from the first pressure sensor and the remote pressure sensor measures or approximates intraocular pressure.

22. The IOP valve of claim 21, further comprising a controller configured to use readings from the first pressure sensor and the remote pressure sensor to control the flow control mechanism to modify aqueous flow through the valve.

23. The IOP valve of claim 22, wherein the remote pressure sensor is disposable in the subconjunctival space of the eye.

24. The IOP valve of claim 1, further comprising:

a first pressure sensor located in a drainage location; and

a remote pressure sensor located remotely from the first pressure sensor such that the remote pressure sensor measures or approximates atmospheric pressure,

wherein a difference between readings from the first pressure sensor and the remote pressure sensor approximates pressure in the drainage location.

25. The IOP valve of claim 24, further comprising a controller configured to use readings from the first pressure sensor and the remote pressure sensor to control the flow control mechanism to modify aqueous flow through the valve.

26. The IOP valve of claim 24, wherein the remote sensor is disposable in the subconjunctival space of the eye.

27. The flow control valve system of claim 1, comprising a latch structurally arranged to maintain the flow control mechanism at a desired setting.

28. The IOP valve of claim 27, wherein the latch is disposed to secure the flexible membrane in a desired position.

29. The IOP valve of claim 27, comprising a controller configured to control the latch based on detected pressures.

30. The IOP valve of claim 27, wherein the flow control mechanism is a mechanical displacement device.

31. A selectable IOP valve for implantation in an eye of a patient, comprising:

a drainage pathway arranged to carry aqueous from an anterior chamber of an eye;

a first flow control pathway in communication with the drainage pathway;

a second flow control pathway in communication with the drainage pathway the first and second flow control pathways being arranged to carry aqueous in parallel from the drainage pathway; and

a flow control mechanism associated with both the first and second flow control pathways, wherein the flow control mechanism comprises a single membrane configured to be displaced to increase or decrease aqueous flow rates through the first and second flow control pathways, and wherein the membrane intersects an axis of each of the first and second flow control pathways to selectively occlude the flow of the aqueous through an end of the first and second flow control pathways.

32. The IOP valve of claim 31, wherein the first and second flow control pathways are structurally configured to permit substantially the same flow rates of aqueous.

33. The TOP valve of claim 31, wherein the first and second flow control pathways are structurally configured to permit different flow rates of aqueous.

34. A method performed by an IOP control system that drains aqueous from an anterior chamber of the eye to a drainage location of the eye, comprising:

detecting pressure within an anterior chamber of the eye;

detecting pressure at a drainage location of the eye;

determining whether to adjust drainage aqueous flow based on the detected pressures by comparing the detected pressures in both the anterior chamber and the drainage location to pre-established acceptable pressures; and

adjusting drainage aqueous flow from the anterior chamber by adjusting access to at least one of a plurality of parallel flow paths to achieve pressures in both the anterior chamber and the drainage location corresponding to the acceptable pressures, wherein adjusting access to the at least one of a plurality of parallel flow paths includes adjusting a flow control mechanism associated with the plurality of parallel flow paths, the flow control mechanism comprising a flexible membrane configured to be displaced to increase or decrease aqueous flow through the at least one of a plurality of parallel flow paths, the flexible membrane intersecting an axis of each of the plurality of parallel flow paths to selectively occlude the flow of the aqueous through an end of the plurality of parallel flow paths.

35. The method of claim 34, comprising detecting an atmospheric pressure reference, and wherein the step of determining whether to adjust drainage aqueous flow includes comparing the detected pressure in the anterior chamber and the atmospheric pressure reference.

36. The method of claim 35, wherein the step of detecting an atmospheric pressure reference includes detecting pressure with a sensor located under the conjunctiva of the eye.

37. The method of claim 34, comprising detecting an atmospheric pressure reference, and wherein the step of determining whether to adjust drainage aqueous flow includes comparing the detected pressure in a drainage location and the atmospheric pressure reference.

38. The method of claim 37, wherein the step of detecting an atmospheric pressure reference includes detecting pressure with a sensor located under the conjunctiva of the eye.

39. The method of claim 34, wherein adjusting drainage aqueous flow comprises controlling access to an array of substantially identical parallel flow pathways.

40. The method of claim 34, wherein adjusting drainage aqueous flow comprises controlling access to a plurality of flow pathways arranged in parallel, where each flow pathway of the plurality of flow pathways is structurally configured to permit a different rate of aqueous flow in response to a given driving pressure differential along the flow pathway.

41. The method of claim 34, wherein adjusting access to one of a plurality of parallel flow paths includes displacing a flexible membrane to modify a flow area.

42. The method of claim 41, further comprising mechanically securing the flexible membrane at a desired displacement to maintain a desired flow setting.

43. The method of claim 41, wherein displacing a flexible membrane to modify a flow area comprises using electrolysis to modify a pressure acting on the flexible membrane.

44. The IOP valve of claim 41, wherein the step of displacing a flexible membrane occurs when an aqueous pressure exceeds a biasing force.