IMPLANTABLE ANALYTE SENSOR

• US 20050242479A1
• Filed: 05/03/2004
• Published: 11/03/2005
• Est. Priority Date: 05/03/2004
• Status: Active Grant

• Current Assignee: DexCom Incorporated
• Original Assignee: DexCom Incorporated
• Inventors: Brauker, James H., Neale, Paul V., Shults, Mark, Brister, Mark, Petisce, James R.
• Granted Patent: US 8,277,713 B2
• Time in Patent Office: Days
• US Class Current: 264/650
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors

Abstract

Abstract of the Disclosure

An implantable analyte sensor including a sensing region for measuring the analyte and a non-sensing region for immobilizing the sensor body in the host. The sensor is implanted in a precisely dimensioned pocket to stabilize the analyte sensor in vivo and enable measurement of the concentration of the analyte in the host before and after formation of a foreign body capsule around the sensor. The sensor further provides a transmitter for RF transmission through the sensor body, electronic circuitry, and a power source optimized for long-term use in the miniaturized sensor body.

Claims

1. A method for manufacturing a multilayer membrane for an analyte sensor, the method comprising:

2. The method of claim 1, wherein the multilayer membrane further comprises an interference layer that substantially prevents passage of potentially electrochemically interfering substances.

3. The method of claim 1, wherein the multilayer membrane further comprises an electrolyte layer comprising a hydrogel for maintaining hydrophilicity at electrochemically reactive surfaces of the analyte sensor.

4. A method for casting a membrane that regulates the transport of glucose, the method comprising:

5. The method of claim 4, wherein the first elevated temperature is between about 60º

C and about 100º

C.

6. The method of claim 5, wherein the first elevated temperature is about 80º

C.

7. The method of claim 4, wherein the predetermined time period is at least about 24 hours.

8. The method of claim 7, wherein the predetermined time period is at least about 44 hours.

9. The method of claim 4, wherein the predetermined ramp rate is between about 3º

C per minute and 12º

C per minute.

10. The method of claim 4, wherein the predetermined ramp rate is about 7º

C per minute.

11. The method of claim 4, wherein the second elevated temperature is at least about 100º

C.

12. A method for casting a membrane for use with an electrochemical glucose sensor, wherein the membrane substantially prevents passage of potentially electrochemically interfering substances, the method comprising:

13. The method of claim 12, wherein the membrane limits the diffusion of hydrophilic species and large molecular weight species.

14. The method of claim 12, wherein membrane comprises a thickness between about 0.1 and 5 microns.

15. The method of claim 12, wherein membrane comprises a thickness between about 0.5 and 3 microns.

16. The method of claim 12, wherein the polymer comprises polyurethane.

17. The method of claim 12, wherein the sufficiently fast casting speed is between about 8 to about 15 inches/second.

18. The method of claim 12, wherein the sufficiently fast casting speed is about 11.5 inches/second.

19. A method for manufacturing an analyte sensor, the method comprising:

20. The method of claim 19, wherein the attaching step comprises a mechanical attachment.

21. The method of claim 20, wherein the mechanical attachment comprises a metal or plastic O-ring adapted to fit around a raised sensing region.

22. The method of claim 20, wherein the mechanical attachment comprises a metal or plastic disc adapted to be press-fit into the sensor body.

23. The method of claim 20, wherein the mechanical attachment comprises a metal or plastic clip adapted to be snap-fit into the sensor body.