Device and method for determining analyte levels

• US 7,136,689 B2
• Filed: 01/19/2005
• Issued: 11/14/2006
• Est. Priority Date: 03/04/1997
• Status: Expired due to Fees

Abstract

Devices and methods for determining analyte levels are described. The devices and methods allow for the implantation of analyte-monitoring devices, such as glucose monitoring devices that result in the delivery of a dependable flow of blood to deliver sample to the implanted device. The devices include unique architectural arrangement in the sensor region that slows accurate date to be obtained over long periods of time.

Claims

1. An implantable device for measuring an analyte in a biological fluid, the device comprising:

a sensor body comprising a sensor and electronics configured to measure the analyte; and

a porous angiogenic layer disposed on at least a portion of the sensor and a member for securing the sensor body to a host tissue, wherein one of the angiogenic layer and securing member is more proximal with respect to the sensor than the other of the angiogenic layer and securing member; and

wherein the sensor comprises an optical sensing mechanism or an acoustic sensing mechanism.

2. The implantable device of claim 1, wherein the optical sensing mechanism or acoustic sensing mechanism is selected from the group consisting of a surface plasmon resonance sensor, a surface acoustic wave sensor, an optical absorbanee sensor, and a polarized light optical rotation sensor.

3. The implantable device of claim 1, wherein the angiogenic layer comprises a biostable material selected from the group consisting of hydrophilic polyvinylidene fluoride, mixed cellulose esters, ePTFE, polyester, polyvinyl chloride, polypropylene, polyethylene, polysulfone, and polymethylmethacrylate.

4. The implantable device of claim 1, further comprising a bioprotective layer located more proximal to the sensor than the angiogenic layer.

5. The implantable device of claim 4, wherein the bioprotective layer comprises a biostable material selected from the group consisting of polytetrafluoroethylene, polypropylene, and polysulfone.

6. The implantable device of claim 4, wherein the angiogenic layer is placed over the bioprotective layer.

7. The implantable device of claim 1, wherein the securing member comprises a material selected from the group consisting of polyester, velour, expanded polytetrafluoroethylene, polytetrafluoroethylene felts, polypropylene cloth, and non-woven polyester.

8. The imnplantable device of claim 1, further comprising a sensing membrane.

9. The implantable device of claim 8, wherein the sensing membrane comprises a resistance layer configured to control a rate of delivery of the analyte through the sensing membrane.

10. The implantable device of claim 8, wherein the sensing membrane comprises an enzyme layer configured to catalyze the analyte with a cofactor.

11. The implantable device of claim 8, wherein the sensing membrane comprises an interference layer configured to allow the analyte to pass through, while preventing passage of an interfering substance.

12. An implantable device for measuring an analyte in a biological fluid, the device comprising:

a sensor body comprising a sensor and electronics configured to measure the analyte; and

a porous angiogenic layer disposed on at least a portion of the sensor and a member for securing the sensor body to a host tissue, wherein one of the angiogenic layer and securing member is more proximal with respect to the sensor than the other of the angiogenic layer and securing member, and wherein the angiogenic layer comprises a biostable material selected from the group consisting of hydrophilic polyvinylidene fluoride, mixed cellulose esters, ePTFE, polyester, polyvinyl chloride, polypropylene, polysulfone, and polymethylmethacrylate.

13. The implantable device of claim 12, further comprising a bioprotective layer located more proximal to the sensor than the angiogenic layer.

14. The implantable device according to claim 13, wherein the bioprotective layer comprises a biostable material selected from the group consisting of polytetrafluoroethylene, polypropylene, and polysulfone.

15. The implantable device of claim 13, wherein the angiogenic layer is placed over the bioprotective layer.

16. The implantable device of claim 12, wherein the securing member comprises a material selected from the group consisting of polyester, velour, expanded polytetrafluoroethylene, polytetrafluoroethylene felts, polypropylene cloth, and non-woven polyester.

17. The implantable device of claim 12, wherein the sensor is an electrochemical sensor.

18. The implantable device of claim 12, further comprising a sensing membrane.

19. The implantable device of claim 18, wherein the sensing membrane comprises a resistance layer configured to control a rate of delivery of the analyte through the sensing membrane.

20. The implantable device of claim 18, wherein the sensing membrane comprises an enzyme layer configured to catalyze the analyte with a cofactor.

21. The implantable device of claim 18, wherein the sensing membrane comprises an interference layer configured to allow the analyte to pass through, while preventing passage of an interfering substance.

22. The implantable device of claim 18, wherein the sensing membrane comprises an electrolyte layer configured maintain a hydrophilic environment at the sensor.

23. The implantable device of claim 12, further comprising an electrolyte phase, the electrolyte phase comprising a free-fluid phase comprising a solution comprising at least one compound that conducts an electric current.