Multilayer Membrane Actuators

• US 20130150775A1
• Filed: 12/09/2011
• Published: 06/13/2013
• Est. Priority Date: 12/09/2011
• Status: Active Grant

• Current Assignee: Alcon Research, LLC (Alcon Incorporated)
• Original Assignee: Alcon Research Limited (Nestle SA)
• Inventors: Dos Santos, Cesario P., Gelvin, Michael L.
• Granted Patent: US 8,840,578 B2
• Time in Patent Office: Days
• US Class Current: 604/9
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts
• CPC Class Codes: A61F 9/007 Methods or devices for eye surgery
• 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 2005/14204 with gas-producing electrochemical cell
• CPC Class Codes: A61M 2005/14513 with secondary fluid driving or regulating the infusion
• CPC Class Codes: A61M 2202/0014 removed from the body
• CPC Class Codes: A61M 2202/04 Liquids
• CPC Class Codes: A61M 2205/8231 using electrochemical gas generating device for the driving gas
• CPC Class Codes: A61M 2210/0612 Eyes
• CPC Class Codes: A61M 27/002 Implant devices for drainage of body fluids from one part of the body to another intraocular A61F9/00781; middle ear A61F11/202
• CPC Class Codes: A61M 5/14276 specially adapted for implantation

Abstract

An IOP control device for implantation in an eye of a patient is disclosed. The device includes a housing and a multilayer membrane. The housing is sized for implantation into the eye and includes an entrance port and an exit port. The membrane is anchored within the housing to form a flow control chamber on a first side and a fluid flow passageway on a second opposing side of the membrane. The chamber is arranged to contain a gas creating a chamber pressure, and the membrane is configured to affect flow through the passageway from the entrance port to the exit port by deflecting in response to changes in the chamber pressure. The membrane comprises a first layer having a higher permeability and a higher flexibility than the second layer, which is disposed adjacent the first layer and restricts the diffusion of gas in the chamber through the membrane.

Claims

1. An IOP control device for implantation in an eye of a patient, comprising:

a housing sized for implantation into the eye of the patient and including an entrance port and an exit port; and

a multilayer membrane anchored within the housing in a manner forming a flow control chamber on a first side of the multilayer membrane and a fluid flow passageway on a second opposing side of the membrane, the flow control chamber being arranged to contain a gas creating a flow control chamber pressure, the multilayer membrane configured to affect flow through the fluid flow passageway from the entrance port to the exit port by deflecting in response to changes in the flow control chamber pressure, the multilayer membrane comprising;

a first layer having a higher permeability and a higher flexibility, and

a second layer having a lower permeability and a lower flexibility disposed adjacent the first layer, the second layer restricting diffusion of gas in the chamber through the multilayer membrane.

2. The IOP control device of claim 1, wherein the multilayer membrane comprises at least one base layer and at least one regulating layer shaped and configured to reduce the gas permeability of the membrane to at least one type of gas.

3. The IOP control device of claim 2, wherein the regulating layer is shaped and configured to reduce the gas permeability of the membrane to hydrogen.

4. The IOP control device of claim 3, wherein the at least one regulating layer includes gold.

5. The IOP control device of claim 2, wherein the regulating layer comprises a continuous layer in contact with the at least one base layer.

6. The IOP control device of claim 2, wherein the regulating layer comprises a non-continuous layer in contact with the at least one base layer.

7. The IOP control device of claim 2, wherein the multilayer membrane further comprises at least one adherent layer shaped and configured to aid the adherence between the at least one regulating layer and the at least one base layer.

8. The IOP control device of claim 7, wherein the at least one adherent layer includes titanium.

9. The IOP control device of claim 1, wherein the multilayer membrane is shaped and configured as a flexible, corrugated membrane.

10. The IOP control device of claim 1, wherein the flow control chamber includes an actuator fluid and an electrolysis system configured to affect the flow control chamber pressure by generating bubbles by converting at least a portion of the actuator fluid to the gas.

11. The IOP control device of claim 10, wherein the flow control chamber comprises a diffusion barrier disposed adjacent the actuator fluid, the diffusion barrier being sized to reduce the rate of state change from gas molecules to liquid molecules.

12. An IOP control system for implantation in an eye of a patient, comprising:

a drainage tube configured to convey aqueous humor from an anterior chamber of the eye; and

an electrolysis-based implantable device in fluid communication with the drainage tube and including a multilayer membrane, the multilayer membrane anchored within the implantable device to form a flow control chamber on a first side of the multilayer membrane, the implantable device being actuatable in response to a flow control chamber pressure and the membrane being configured to control flow rates of the aqueous humor along the drainage tube by deflecting in response to the flow control chamber pressure.

13. The IOP control system of claim 12, wherein the membrane comprises at least one base layer and at least one regulating layer shaped and configured to reduce the gas permeability of the membrane to at least one type of gas.

14. The IOP control system of claim 13, wherein the regulating layer is shaped and configured to reduce the gas permeability of the membrane to hydrogen.

15. The IOP control system of claim 14, wherein the at least one regulating layer includes gold.

16. The IOP control system of claim 13, wherein the regulating layer comprises a continuous layer in contact with the at least one base layer.

17. The IOP control system of claim 13, wherein the regulating layer comprises a non-continuous layer in contact with the at least one base layer.

18. The IOP control system of claim 13, wherein the multilayer membrane further comprises at least one adherent layer shaped and configured to aid the adherence between the at least one regulating layer and the at least one base layer.

19. The IOP control system of claim 18, wherein the at least one adherent layer includes titanium.

20. The IOP control system of claim 12, wherein the multilayer membrane is shaped and configured as a flexible, corrugated membrane.

21. A method of regulating drainage from an anterior chamber of an eye with an implantable device, comprising:

directing fluid through a fluid flow passageway formed in part by a flexible, multilayer membrane comprising at least one base layer and at least one regulating layer shaped and configured to reduce gas permeability through the membrane; and

modifying the amount of drainage through the implantable device in response to a flow control pressure acting on the multilayer membrane by deflecting the membrane to increase or decrease the size of the fluid flow passageway in the membrane valve.

22. The method of claim 21, wherein an electrolysis process greets the flow control pressure acting on the multilayer membrane.

23. The method of claim 22, wherein the at least one regulating layer is shaped and configured to reduce the gas permeability of the membrane to hydrogen.