Oxygen enhancing membrane systems for implantable devices

• US 7,379,765 B2
• Filed: 07/21/2004
• Issued: 05/27/2008
• Est. Priority Date: 07/25/2003
• Status: Active Grant

• Current Assignee: DexCom Incorporated
• Original Assignee: DexCom Incorporated
• Inventors: Brauker, James H., Carr-Brendel, Victoria, Simpson, Peter C., Tapsak, Mark A., Petisce, James
• Primary Examiner(s): Marmor, II; Charles A.
• Assistant Examiner(s): Natnithithadha; Navin
• Application Number:
  US10/896,639
• Publication Number:
  US 20050054909A1
• Time in Patent Office: 1,406 Days
• Field of Search: 600345-366, 600/372, 600/373, 600/377, 600/395, 600/309, 20440301-40314, 204/415, 205/778, 205/782.5, 205/783, 205/937
• 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 electrochemical glucose sensor for determining a presence or a concentration of glucose in a fluid, the sensor comprising:

a multilayer membrane system comprising a cell impermeable domain that is substantially impermeable to cells, a resistance domain configured to restrict a flow of the glucose therethrough, and an enzyme domain comprising an enzyme that reacts with the glucose in the fluid as it passes though the enzyme domain; and

a working electrode comprising a conductive material, wherein the working electrode is configured to measure a product of a reaction of the enzyme with the glucose,

wherein the enzyme domain, the resistance domain, and the cell impermeable domain each comprise a polymer material with a higher oxygen solubility than an oxyhydrocarbon polymer and wherein each of the enzyme domain, the resistance domain, and the cell impermeable domain is configured to be permeable to the glucose.

2. The electrochemical sensor of claim 1, wherein the polymer material is selected from the group consisting of silicone, fluorocarbon, and perfluorocarbon.

3. The electrochemical sensor of claim 1, wherein the resistance domain comprises a polymer material selected from the group consisting of silicone, fluorocarbon, and perfluorocarbon.

4. The electrochemical sensor of claim 1, wherein the cell impermeable domain comprises a polymer material selected from the group consisting of silicone, fluorocarbon, and perfluorocarbon.

5. The electrochemical sensor of claim 1, further comprising a cell disruptive domain that comprises a substantially porous structure, wherein the cell disruptive domain is located more distal to the working electrode than the enzyme domain, and wherein the cell disruptive domain comprises a polymer material with high oxygen solubility.

6. The electrochemical sensor of claim 5, wherein the cell disruptive domain comprises a polymer material selected from the group consisting of silicone, fluorocarbon, and perfluorocarbon.

7. The electrochemical sensor of claim 1, further comprising an interference domain configured to limit or block interfering species, wherein the interference domain is located more proximal to the working electrode than the enzyme domain, and wherein the interference domain comprises a polymer material with a high oxygen solubility.

8. The electrochemical sensor of claim 7, wherein the interference domain comprises a polymer material selected from the group consisting of silicone, fluorocarbon, and perfluorocarbon.

9. The electrochemical sensor of claim 1, further comprising an electrolyte domain configured to provide hydrophilicity at the working electrode, wherein the electrolyte domain is located more proximal to the working electrode than the enzyme domain, and wherein the electrolyte domain comprises a polymer material with a high oxygen solubility.

10. The electrochemical sensor of claim 9, wherein the electrolyte domain comprises a polymer material selected from the group consisting of silicone, fluorocarbon, and perfluorocarbon.

11. The electrochemical sensor of claim 1, wherein the polymer material has a higher oxygen solubility than hydrocarbonaceous polymers.

12. The electrochemical sensor of claim 1, wherein the polymer material has an oxygen permeability of at least about 50 Barrer.

13. The electrochemical sensor of claim 1, wherein the polymer material has an oxygen permeability of at least about 100 Barrer.

14. The electrochemical sensor of claim 1, wherein the polymer material has an oxygen permeability of at least about 500 Barrer.

15. An electrochemical glucose sensor for determining a presence or a concentration of glucose in a fluid, the glucose sensor comprising:

a membrane system comprising;

an enzyme domain comprising an enzyme that reacts with the glucose in the fluid as it passes through the enzyme domain; and

a resistance domain configured to partially restrict a flow of the glucose therethrough, wherein the resistance domain is located more distal to the working electrode than the enzyme domain;

a cell impermeable domain that is substantially impermeable to cells; and

a working electrode, wherein the working electrode is configured to measure a product of a reaction of the enzyme with the glucose,

wherein the resistance domain and the cell impermeable domain each comprise a silicone polymer blended with a hydrophilic polymer and are configured to be at least partially permeable to the glucose.

16. The electrochemical sensor of claim 15, further comprising a cell disruptive domain that comprises a substantially porous structure configured to allow tissue ingrowth, wherein the cell disruptive domain is located more distal to the working electrode than the cell impermeable domain, and wherein the cell disruptive domain comprises a polymer material with high oxygen solubility.

17. The electrochemical sensor of claim 16, wherein the cell disruptive domain comprises a polymer material selected from the group consisting of silicone, fluorocarbon, and perfluorocarbon.

18. The electrochemical sensor of claim 15, wherein the silicone polymer blended with the hydrophilic polymer has a higher oxygen solubility than hydrocarbonaceous polymers.

19. The electrochemical sensor of claim 15, wherein the silicone polymer blended with the hydrophilic polymer has an oxygen permeability of at least about 50 Barrer.

20. The electrochemical sensor of claim 15, wherein the silicone polymer blended with the hydrophilic polymer has an oxygen permeability of at least about 100 Barrer.

21. The electrochemical sensor of claim 15, wherein the silicone polymer blended with the hydrophilic polymer has an oxygen permeability of at least about 500 Barrer.