Oxygen enhancing membrane systems for implantable devices

• US 8,909,314 B2
• Filed: 07/20/2011
• Issued: 12/09/2014
• Est. Priority Date: 07/25/2003
• Status: Active Grant

• Current Assignee: DexCom Incorporated
• Original Assignee: DexCom Incorporated
• Inventors: Petisce, James R., Tapsak, Mark A., Simpson, Peter C., Carr-Brendel, Victoria E., Brauker, James H.
• Primary Examiner(s): Natnithithadha, Navin
• Application Number:
  US13/187,277
• Publication Number:
  US 20110275919A1
• Time in Patent Office: 1,238 Days
• Field of Search: 600345-366, 600/309
• US Class Current: 600/345
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61B 5/14503 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1468 using chemical or electrochemical methods, e.g. by polarographic means A61B5/1486 takes precedence
• CPC Class Codes: A61B 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: A61B 5/14735 comprising an immobilised reagent
• CPC Class Codes: A61B 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
• CPC Class Codes: C12Q 1/002 Electrode membranes
• CPC Class Codes: C12Q 1/006 for glucose

Abstract

The present invention relates generally to systems and methods for increasing oxygen availability to implantable devices. The preferred embodiments provide a membrane system configured to provide protection of the device from the biological environment and/or a catalyst for enabling an enzymatic reaction, wherein the membrane system includes a polymer formed from a high oxygen soluble material. The high oxygen soluble polymer material is disposed adjacent to an oxygen-utilizing source on the implantable device so as to dynamically retain high oxygen availability to the oxygen-utilizing source during oxygen deficits. Membrane systems of the preferred embodiments are useful for implantable devices with oxygen-utilizing sources and/or that function in low oxygen environments, such as enzyme-based electrochemical sensors and cell transplantation devices.

Claims

1. An implantable device for continuous in vivo measurement of an analyte concentration in a host, the implantable device comprising:

a sensor configured to operatively connect with electronic circuitry, wherein the sensor is configured to generate a signal indicative of a concentration of an analyte in a host; and

a membrane located over the sensor, wherein the membrane has a thickness of from about 3 microns to about 100 microns, wherein the membrane has an oxygen permeability of from about 3 Barrers to about 1000 Barrers, and wherein the membrane has an oxygen solubility that is at least about three times greater than an oxygen solubility of water.

2. The implantable device of claim 1, wherein the membrane has an oxygen solubility that is at least about five times greater than the oxygen solubility of water.

3. The implantable device of claim 1, wherein the membrane has an oxygen solubility that is at least about ten times greater than the oxygen solubility of water.

4. The implantable device of claim 1, wherein the membrane has an oxygen permeability of from about 5 Barrers to about 500 Barrers.

5. The implantable device of claim 1, wherein the membrane has an oxygen permeability of from about 25 Barrers to about 250 Barrers.

6. The implantable device of claim 1, wherein the membrane has a thickness of from about 4 microns to about 25 microns.

7. The implantable device of claim 1, wherein the membrane comprises an enzyme domain, wherein the enzyme domain comprises an enzyme configured to react with the analyte.

8. The implantable device of claim 1, wherein the membrane is configured to limit or block passage of an interfering species therethrough.

9. The implantable device of claim 1, wherein the membrane comprises a copolymer comprising silicone and polyvinylpyrrolidone.

10. The implantable device of claim 1, wherein the analyte is glucose.

11. An implantable device for continuous in vivo measurement of an analyte concentration in a host, the implantable device comprising:

a sensor configured to operatively connect with electronic circuitry, wherein the sensor is configured to generate a signal indicative of a concentration of an analyte in a host; and

a membrane located over the sensor, the membrane comprising;

a first domain comprising an enzyme configured to react with the analyte, wherein the first domain further comprises a material having an oxygen solubility at least about three times greater than an oxygen solubility of water; and

a second domain configured to control a flux therethrough of an analyte to the first domain, wherein the second domain comprises a material having an oxygen permeability of from about 3 Barrers to about 1000 Barrers.

12. The implantable device of claim 11, wherein the material of the first domain has an oxygen solubility at least about five times greater than the oxygen solubility of water.

13. The implantable device of claim 11, wherein the material of the first domain has an oxygen solubility at least about ten times greater than the oxygen solubility of water.

14. The implantable device of claim 11, wherein the material of the first domain has an oxygen solubility of about 50-volume %.

15. The implantable device of claim 11, wherein the material of the second domain has an oxygen permeability of from about 5 Barrers to about 500 Barrers.

16. The implantable device of claim 11, wherein the material of the second domain has an oxygen permeability of from about 25 Barrers to about 250 Barrers.

17. The implantable device of claim 11, wherein the membrane has a thickness of from about 3 microns to about 100 microns.

18. The implantable device of claim 11, wherein the membrane further comprises a third domain configured to limit or block passage of an interfering species therethrough.

19. The implantable device of claim 11, wherein the material of the second domain comprises a copolymer comprising silicone and polyvinylpyrrolidone.

20. The implantable device of claim 11, wherein the analyte is glucose.