Active bimodal valve system for real-time IOP control

• US 8,585,631 B2
• Filed: 10/18/2011
• Issued: 11/19/2013
• Est. Priority Date: 10/18/2011
• Status: Active Grant

• Current Assignee: Alcon Research, LLC (Alcon Incorporated)
• Original Assignee: Alcon Research Limited (Nestle SA)
• Inventors: Dacquay, Bruno
• Primary Examiner(s): DEAK, LESLIE R
• Application Number:
  US13/275,711
• Publication Number:
  US 20130096483A1
• Time in Patent Office: 763 Days
• Field of Search: 604/8, 604/9
• 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: A61M 2205/04 implanted
• CPC Class Codes: A61M 2205/3341 stabilising pressure or flow to avoid excessive variation
• CPC Class Codes: A61M 2205/3344 Measuring or controlling pressure at the body treatment site
• CPC Class Codes: A61M 2210/0612 Eyes
• CPC Class Codes: A61M 39/22 Valves or arrangement of valves A61M39/02, A61M39/0247, A61M39/16 take precedence; regulating valves in infusion systems A61M5/16881; in devices worn by the patient for the reception of urine, faeces, catamenial or other discharge, or in colostomy devices A61F5/4405
• CPC Class Codes: A61M 39/227 Valves actuated by a secondary fluid, e.g. hydraulically or pneumatically actuated valves

Abstract

An IOP control system provides drainage from an anterior chamber of the eye to a drainage location at the eye. The system has a valve with an open flow position and a closed zero flow position. A sensor system includes a first sensor arranged to detect a first pressure representative of IOP. A controller receives data representing the detected pressure from the sensor system and compares the data to an upper pressure threshold and a lower pressure threshold to determine whether to change the state of the valve system in a bimodal fashion.

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 valve system having an open flow position and a closed zero flow position, the open flow position permitting fluid flow through the valve system, the closed zero flow position substantially preventing fluid flow through the valve system, the valve system comprising;

a housing;

a flexible membrane coupled with the housing, the flexible membrane having a first side and a second side;

a chamber bounded by an interior of the housing and a first side of the flexible membrane, the chamber holding an actuation fluid;

an entrance port and an exit port located in the housing adjacent to the second side of the flexible membrane;

a passage located inside the housing, the passage fluidly coupling the entrance port to the exit port;

wherein when the valve system is in the closed zero flow position, the flexible membrane occludes the entrance port;

a sensor system comprising a first sensor arranged to detect a first pressure representative of a real-time parameter of the eye; and

a controller arranged to receive data from the sensor system and compare data representing the detected pressure to a preestablished upper pressure threshold and a preestablished lower pressure threshold to determine whether to change the state of the valve system in a bimodal fashion from one of an open flow position and the closed zero flow position to the other of the open flow position and the closed zero flow position.

2. The IOP control system of claim 1, wherein the first sensor of the sensor system is arranged to detect the anterior chamber pressure.

3. The IOP control system of claim 2, wherein the sensor system comprises a second sensor arranged to detect the drainage site pressure.

4. The IOP control system of claim 3, wherein the sensor system comprises a third sensor arranged to detect an atmospheric pressure.

5. The IOP control system of claim 1, wherein the sensor system comprises a second sensor arranged to detect an atmospheric pressure, and

wherein the controller is arranged to determine a value representative of IOP, the controller being arranged to compare the IOP to the upper and lower pressure thresholds.

6. The IOP control system of claim 5, wherein the controller is also arranged to determine a value representative of drainage site pressure, the controller being arranged to compare the IOP to the upper and lower pressure thresholds and arranged to compare the drainage site pressure to the upper pressure threshold.

7. The IOP control system of claim 6, wherein the upper pressure threshold for the drainage location is in the range of about 12-15 mmHg.

8. The IOP control system of claim 1, wherein the processor is configured to generate a signal to open the valve when the data representing the pressures is above the upper threshold.

9. The IOP control system of claim 8, wherein the processor is configured to generate a signal to close the valve when the data representing the pressures is below the lower threshold.

10. The IOP control system of claim 1, wherein the upper pressure threshold for IOP is in the range of about 15 to 18 mmHg and the lower pressure threshold is in the range of about 8 to 10 mmHg.

11. The IOP control system of claim 1, further comprising an interface arranged to receive an input from a health care provider establishing one of the upper pressure threshold and the lower pressure threshold.

12. The IOP control system of claim 1, wherein the controller is configured to generate and output a signal to the valve system to change from said one of the open flow position and the closed zero flow position to the other of the open flow position and the closed zero flow position.

13. The IOP control system of claim 1, wherein the controller is configured to monitor the data from the sensor system in real time.

14. The IOP control system of claim 1, wherein the controller and valve system are arranged so that the open condition coincides with the open flow condition for the valve system.

15. A method for treating glaucoma using an IOP control system, comprising:

receiving an input representing a target pressure range for an eye of a patient, the target pressure range having an upper pressure threshold and a lower pressure threshold the upper and lower thresholds being extreme ends of the range of the target pressure range;

detecting with at least one pressure sensor an actual pressure associated with the eye of a patient;

comparing the actual pressure to the target pressure range; and

actuating a valve in a bimodal manner between a drainage flow-permitting condition and a drainage flow-preventing condition based on the comparison of the actual pressure to the target pressure range;

wherein actuating the valve in the drainage flow-preventing condition comprises performing electrolysis on an actuator fluid held in a chamber bounded by an interior of a valve housing and a side of a flexible membrane, such that a gas produced by electrolysis deflects the flexible membrane thereby occluding a port in the valve housing.

16. The method of claim 15, wherein the target pressure range for an eye of a patient is measured as an acceptable IOP range for the eye.

17. The method of claim 15, wherein the step of detecting with at least one pressure sensor comprises accounting for an anterior chamber pressure.

18. The method of claim 17, wherein the step of detecting with at least one pressure sensor further comprises accounting for an atmospheric pressure.

19. The method of claim 15, wherein receiving an input comprises receiving an input from one of a health care provider and a manufacturer.

20. The method of claim 15, wherein actuating a valve in a bimodal manner comprises opening the valve only when the comparison of the actual pressure to the target pressure range indicates that the pressure is greater than the upper pressure threshold.

21. The method of claim 15, wherein actuating a valve in a bimodal manner comprises closing the valve only when the comparison of the actual pressure to the target pressure range indicates that the pressure is less than the lower pressure threshold.