Selectable Varied Control Valve Systems For IOP Control Systems

• US 20130085440A1
• Filed: 10/03/2011
• Published: 04/04/2013
• Est. Priority Date: 10/03/2011
• Status: Active Grant

• Current Assignee: Alcon Incorporated
• Original Assignee: Sebastian Bohm
• Inventors: Field, Leslie A., Bhm, Sebastian
• Granted Patent: US 9,072,588 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

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 the 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, and

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 passageways.

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 flow control mechanism comprises a flexible membrane 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 passageway until an aqueous pressure exceeds the biasing force.

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

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

13. The TOP 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 TOP 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 flow control valve system 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 a 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 TOP 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 TOP 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 second pressure sensor measures or approximates intraocular pressure.

22. The TOP valve of claim 21, further comprising a controller configured to use readings from the first pressure sensor and the second 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 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 sensors 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 TOP 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 TOP 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 flow control mechanism comprises a flexible membrane configured to displace the change of flow through at least one of the plurality of flow control pathways, the latch being 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 one of a hook and a mechanical displacement device.

31. 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 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.

32. The method of claim 31, 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.

33. The method of claim 32, wherein the step of detecting an atmospheric pressure reference includes detecting pressure with a sensor located under the conjunctiva of the eye.

34. The method of claim 31, 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.

35. The method of claim 34, wherein the step of detecting an atmospheric pressure reference includes detecting pressure with a sensor located under the conjunctiva of the eye.

36. The method of claim 31, wherein adjusting drainage aqueous flow comprises controlling access to an array of substantially identical parallel flow pathways.

37. The method of claim 31, 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.

38. The method of claim 31, wherein adjusting access to one of a plurality of parallel flow paths includes displacing a flexible membrane to modify a flow area.

39. The method of claim 38, further comprising mechanically securing the flexible membrane at a desired displacement to maintain a desired flow setting.

40. The method of claim 38, wherein displacing a flexible membrane to modify a flow area comprises using electrolysis to modify a pressure acting on the flexible membrane.

41. The IOP valve of claim 38, wherein the step of displacing a flexible membrane occurs when an aqueous pressure exceeds a biasing force.

42. 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; and

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.

43. The IOP valve of claim 42, comprising a flow control mechanism associated with both the first and second flow control pathways.

44. The IOP valve of claim 43, wherein the first and second flow control pathways are structurally configured to permit substantially the same flow rates of aqueous.

45. The IOP valve of claim 43, wherein the flow control mechanism comprises a single membrane configured to influence flow rates though the first and second flow control pathways.

46. The IOP valve of claim 42, comprising independent first and second flow control mechanisms respectively associated with the first and second flow control pathways.

47. The IOP valve of claim 46, wherein the first and second flow control pathways are structurally configured to permit different flow rates of aqueous.

48. The IOP valve of claim 47, wherein the first and second flow control pathways comprises respective first and second orifices, the first orifice having a size different than the second orifice.

49. The IOP valve of claim 46, wherein each of the first and second flow control mechanisms comprise a membrane configured to influence flow rates though the respective first and second flow control pathways.