Bubble-Driven IOP Control System

• US 20130144202A1
• Filed: 12/06/2011
• Published: 06/06/2013
• Est. Priority Date: 12/06/2011
• Status: Active Grant

• Current Assignee: Alcon Research, LLC (Alcon Incorporated)
• Original Assignee: Alcon Research Limited (Nestle SA)
• Inventors: Field, Leslie, Rickard, Matthew
• Granted Patent: US 8,753,305 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

An intraocular pressure control system for implantation in an eye of a patient to provide drainage from an anterior chamber of the eye to a drainage location at the eye includes a drainage tube and a valve system arranged to control drainage flow between the anterior chamber and the drainage site, the valve system being configured to control fluid flow using an electrolysis process and closed loop feedback from pressure sensors able to determine: flow rate, TOP, bleb pressure, and internal valve pressure.

Claims

1. An IOP control system for implantation in an eye of a patient to provide drainage from an anterior chamber of the eye to a drainage location at the eye, comprising:

a drainage tube with a first end configured to be located in the anterior chamber of an eye and a second end, the tube being configured to convey fluid from the anterior chamber toward the drainage location to relieve IOP; and

a valve system in fluid communication with the drainage tube and configured for implantation in the eye, the valve system being arranged to control drainage flow through the drainage tube between the anterior chamber and the drainage site, the valve system being configured to control fluid flow using an electrolysis process.

2. The IOP control system of claim 1, wherein the valve system comprises an actuator liquid and the electrolysis system is configured to generate bubbles by converting at least a portion of the actuator liquid to a gas.

3. The IOP control system of claim 2, wherein the electrolysis system comprises a pair of electrodes.

4. The IOP control system of claim 3, wherein the pair of electrodes are interdigitated.

5. The IOP control system of claim 2, wherein the valve system comprises a diffusion barrier disposed adjacent the actuator liquid, the diffusion barrier being sized to reduce the rate of state change from gas molecules to liquid molecules.

6. The IOP control system of claim 1, wherein the valve system comprises an aqueous flow passageway and a flexible membrane forming a part of the passageway, the flexible membrane being configured to flex as a result of an electrolysis process.

7. The IOP control system of claim 6, wherein the flexible membrane is configured to displace and modify the cross-sectional area of the passageway.

8. The IOP control system of claim 6, wherein the passageway includes a first portion having a flow path substantially perpendicular to the flexible membrane

9. The IOP control system of claim 6, wherein the flow passageway comprises a first portion directed substantially at a central portion of the flexible membrane, such that flexure of the membrane affects the flow rate of fluid through the first portion.

10. The IOP control system of claim 6, wherein the flexible membrane has corrugations, to increase the flexibility of the membrane.

11. The IOP control system of claim 1, wherein the valve system comprises a first valve and a second valve connected in series, each of the first and second valves being configured to control flow using an electrolysis process.

12. The IOP control system of claim 1, further comprising a pump.

13. The IOP control system of claim 12, wherein the pump comprises an electrolysis system.

14. The IOP control system of claim 1, further comprising a sensor system comprising:

a first sensor configured to detected pressure in the anterior chamber;

a second sensor configured to detect atmospheric pressure; and

a third sensor configured to detect pressure at the drainage site.

15. The IOP control system of claim 14, further comprising a processor configured to receive data from the first, second, and third sensors and send control signals to the valve system based on the data.

16. The IOP control system of claim 15, further comprising a power source coupled to processor and valve system.

17. The IOP control system of claim 15, further comprising a radio frequency antenna coupled to the power source and processor for recharging, programming and data transfer.

18. The IOP control system of claim 14, further comprising a first barrier separating the first and second sensor and a second barrier separating the second and third sensor, and a third barrier separating the first and third sensors.

19. The TOP control system of claim 18, wherein the third barrier separating the first sensor and the third sensor is the valve system.

20. The TOP control system of claim 14, wherein the second sensor is configured to be disposed under the subconjuctiva.

21. The TOP control system of claim 14, wherein the valve system comprises a plate style shape having a barrier thereon, and the second sensor is disposed on a top of the plate and the third sensor is disposed on the bottom in contact with the drainage site.

22. An IOP control system for implantation in an eye of a patient to provide drainage from an anterior chamber of the eye to a drainage location at the eye, comprising:

a drainage tube with a first end configured to be located in an anterior chamber of an eye, the tube being configured to convey fluid from the anterior chamber;

a first sensor configured to detect pressure in the anterior chamber;

a second sensor configured to detect atmospheric pressure;

a third sensor configured to detect pressure at the drainage site;

a valve system in fluid communication with the drainage tube and configured for implantation in the eye, the valve system being arranged to control drainage flow through the drainage tube between the anterior chamber and the drainage site; and

a processor in communication with and configured to receive data from the first, second, and third sensors, the processor being configured to control the valve system based on the received data to maintain desired pressures in the anterior chamber and at the drainage site.

23. The TOP control system of claim 22, wherein the valve system is configured to control drainage fluid flow using an electrolysis process.

24. The TOP control system of claim 22, wherein a radio frequency antenna coupled to an onboard power source and processor for recharging, programming and data transfer.

25. The TOP control system of claim 22, further comprising a first barrier separating the first and second sensor and a second barrier separating the second and third sensor, and a third barrier separating the first and third sensors.

26. The IOP control system of claim 25, wherein the third barrier separating the first sensor and the third sensor is the valve system.

27. The IOP control system of claim 22, wherein the second sensor is configured to be disposed under the subconjuctiva.

28. The IOP control system of claim 22, wherein the valve system comprises a plate style shape having a barrier thereon, and the second sensor is disposed on a top of the plate and the third sensor is disposed on the bottom in contact with the drainage site.

29. A method performed by an IOP control system that drains fluid 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 fluid flow based on the detected pressures by comparing the detected pressures in both the anterior chamber and the drainage location to preestablished acceptable pressures or pressure profiles as a function of time; and

adjusting drainage fluid flow from the anterior chamber using a valve system to achieve pressures in both the anterior chamber and the drainage location corresponding to the acceptable pressures or pressure profiles as a function of time.

30. The method of claim 29, wherein adjusting drainage fluid flow comprises generating and directing a current through electrodes to perform an electrolysis procedure in a valve system implanted at the eye.

31. The method of claim 29, wherein adjusting drainage fluid flow comprises deflecting a flexible membrane forming a part of a wall of a passageway in the valve system to increase and decrease the cross sectional area of the passageway.

32. The method of claim 29, wherein adjusting drainage fluid flow comprises directing fluid through a valve system comprising first and second control valves, each control valve being independently operable to increase and decrease flow through the valve system.