Methods and devices for removing interfering species

• US 6,615,078 B1
• Filed: 04/21/2000
• Issued: 09/02/2003
• Est. Priority Date: 04/22/1999
• Status: Expired due to Term

• Current Assignee: LifeScan IP Holdings, LLC
• Original Assignee: Cygnus, Inc. (Johnson & Johnson)
• Inventors: Vijayakumar, Prema, Soni, Pravin, Uhegbu, Christopher, Van Wyhe, Michelle, Reidy, Michael, Burson, Kim K., Pudlo, Jeffrey
• Primary Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US09/556,486
• Time in Patent Office: 1,229 Days
• Field of Search: 604/19, 604/20, 604/21, 604/500, 604/501, 604/504, 600/300, 600/309, 600/345-348, 600/362, 600/372, 600/363
• US Class Current: 604/20
• CPC Class Codes: A61N 1/30 Apparatus for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body, or cataphoresis

Abstract

This invention relates to methods for reducing the presence of a compound in an ionically conductive material, e.g., for use in iontophoretic devices, wherein the presence of the compound interferes with detecting a selected analyte. Removal of the compound can typically take place either during or after the manufacture of the ionically conductive material or an assembly comprising this material. Also disclosed are methods for generating selectively permeable barriers on the reactive faces of electrodes. Further, this invention relates to hydrogels comprising one or more biocides, as well as assemblies containing such hydrogels.

Claims

1. A hydrogel, comprising:

polyethylene oxide present in an amount of about 4% to about 20% by weight based on the total weight of the hydrogel;

water in an amount of about 95% or less based on the total weight of the hydrogel;

a chloride salt, wherein background electrical signal in the gel is less than approximately 200 nA;

a phosphate buffer in an amount sufficient to maintain a pH in the hydrogel in the range of 6 to 8;

an enzyme composition comprising glucose oxidase, said glucose oxidase present in an amount of from about 10 units to about 5,000 units per gram of the total weight of the hydrogel; and

a biocide comprising an undecylenate.

2. The hydrogel of claim 1, wherein said biocide comprises undecylenic acid, a salt of undecylenic acid, or mixtures thereof.

3. The hydrogel of claim 1, wherein said background electrical signal is less than approximately 50 nA.

4. The hydrogel of claim 1, wherein said enzyme composition further comprises a mutarotase enzyme.

5. The hydrogel of claim 1, wherein (i) the glucose oxidase can catalyze a reaction between glucose and oxygen resulting in the generation of hydrogen peroxide, and (ii) hydrogen peroxide degradative components of the enzyme composition are reduced such that a quantitation of hydrogen peroxide produced by the glucose oxidase reaction is not compromised.

6. The hydrogel of claim 1, having a flat configuration and a thickness in a range of about 1 mil to about 60 mils.

7. The hydrogel of claim 6, having a first and a second surface area wherein each surface area is in a range of about 0.5 cm² to about 10 cm² and wherein the hydrogel has a thickness of from about 1 mil to 10 mils.

8. The hydrogel of claim 1 further comprising a structural support material embedded in the hydrogel.

9. The hydrogel of claim 1, wherein the hydrogel is substantially planar and has first and second surfaces, said hydrogel further comprising first and second release liners respectively disposed on the first surface and the second surfaces, and a non-woven material embedded in the material.

10. The hydrogel of claim 1, wherein said hydrogel has sufficient flexibility so as to conform to human skin.

11. The hydrogel of claim 1, wherein the enzyme composition comprises a recombinant or synthetic glucose oxidase.

12. The hydrogel of claim 1, wherein the enzyme is present in an amount of about 200 units or more of enzyme per gram weight of the hydrogel.

13. The hydrogel of claim 1, wherein one or more components of the gel have been treated to remove compounds that cause background electrical signal.

14. The hydrogel of claim 13 wherein one or more of said gel components have been treated using a diafiltration procedure to remove electroactive compounds therefrom.

15. The hydrogel of claim 1, wherein the buffering agent is sufficient to maintain a pH of about 7.4.

16. The hydrogel of claim 8 wherein the structural support material is a nonwoven material.

17. The hydrogel of claim 1, wherein said hydrogel is substantially planar and has a thickness of about 10 mils to about 60 mils.

18. The hydrogel of claim 17 wherein the hydrogel has a thickness of about 25 mils.

19. The hydrogel of claim 1, wherein said hydrogel is substantially planar and has a thickness of about 1 mil to about 25 mils.

20. The hydrogel of claim 19 wherein the hydrogel has a thickness of about 5 mils.

21. A method for electroosmotically extracting glucose through the surface of the skin of a subject and into a hydrogel comprising

applying a device comprising the hydrogel of claim 1, said hydrogel in contact with an electrode, to the skin of the subject, and

generating an electrical current that moves the glucose through the skin and into the hydrogel.

22. A method for detecting an amount of glucose in a subject, comprising

extracting glucose through a skin surface of the subject using a device comprising the hydrogel of claim 1 contact with an electrode,

generating an electrical current that moves the glucose through the skin and into the hydrogel,

detecting the amount of glucose present in the hydrogel, and

relating the amount of glucose in the hydrogel to the amount of glucose in the subject.

23. The hydrogel of claim 1, wherein said hydrogel further comprises bisacrylamide.

24. The hydrogel of claim 1, wherein said biocide is present in the hydrogel at a concentration of between about 0.01% to about 5% based on the total weight of the hydrogel.

25. The hydrogel of claim 24, wherein said biocide is present in the hydrogel at a concentration of between about 0.1% to about 1% based on the total weight of the hydrogel.

26. The hydrogel of claim 25, wherein said biocide is present in the hydrogel at a concentration of between about 0.2% to about 0.5% based on the total weight of the hydrogel.