Methods of manufacturing glucose measuring assemblies with hydrogels

• US 7,183,068 B2
• Filed: 02/17/2005
• Issued: 02/27/2007
• Est. Priority Date: 04/22/1999
• Status: Expired due to Term

• Current Assignee: LifeScan IP Holdings, LLC
• Original Assignee: Animas Technologies LLC (Johnson & Johnson)
• Inventors: Vijayakumar, Prema, Soni, Pravin, Uhegbu, Christopher, Van Wyhe, Michelle, Reidy, Michael, Burson, Kim K., Pudlo, Jeffrey
• Primary Examiner(s): Gitomer; Ralph
• Application Number:
  US11/060,524
• Publication Number:
  US 20050170448A1
• Time in Patent Office: 740 Days
• Field of Search: 435/14, 435/25, 205/777.5, 422/60, 424/94.1, 424/449, 424/488
• US Class Current: 435/14
• 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 method of manufacturing a collection assembly for use in a glucose sampling system and for electrochemical detection of an amount or concentration of glucose, the method comprising:

providing a hydrogel comprising;

polyethylene oxide present in an amount of about 5% to about 20% by weight based on the total weight of the hydrogel;

water in an amount of about 50% or more and about 95% or less based on the total weight of the hydrogel;

a chloride salt, wherein a 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, wherein said hydrogel comprises a first surface and a second surface;

contacting the first surface of the hydrogel with a mask layer, the mask layer comprising a material that is substantially impermeable to glucose or derivatives thereof, wherein the mask layer (i) has an inner face and an outer face, and the inner face is positioned in facing relationship with the first surface of the hydrogel, and (ii) defines a first opening that exposes at least a portion of the first surface of the hydrogel, and

contacting the second surface of the hydrogel with a gel retaining layer, the gel retaining layer comprising an inner face and an outer face, wherein the inner face is positioned in facing relationship with the second surface of the hydrogel, and wherein the gel retaining layer defines a first opening that exposes at least a portion of the second surface of the hydrogel to complete the collection assembly.

2. The method of manufacturing of claim 1, wherein said collection assembly is formed as a laminate.

3. The method of manufacturing of claim 1, further comprising positioning a release liner in contact with the mask layer.

4. The method of manufacturing of claim 3, further comprising positioning a plow-fold liner in contact with the gel retaining layer.

5. The method of manufacturing of claim 1, wherein the polyethylene oxide of said hydrogel comprises crosslinking.

6. The method of manufacturing of claim 5, wherein said crosslinking is achieved by thermal reaction, chemical reaction, or providing ionizing radiation.

7. The method of manufacturing of claim 6, wherein said ionizing radiation is provided by electron beam radiation, UV radiation, or gamma radiation.

8. The method of manufacturing of claim 1, wherein said biocide comprises undecylenic acid, a salt of undecylenic acid, or mixtures thereof.

9. The method of manufacturing of claim 1, wherein said background electrical signal is less than approximately 50 nA.

10. The method of manufacturing of claim 1, wherein said enzyme composition further comprises a mutarotase enzyme.

11. The method of manufacturing of claim 1, wherein (i) said glucose oxidase which catalyzes a reaction between glucose and oxygen resulting in the generation of hydrogen peroxide, and (ii) hydrogen peroxide degradative components of the hydrogel are reduced.

12. The method of manufacturing of claim 1, wherein said hydrogel further comprises a structural support material embedded in the hydrogel.

13. The method of manufacturing of claim 1, wherein one or more components of said hydrogel are treated to remove compounds that cause background electrical signals.

14. The method of manufacturing of claim 13, wherein one or more of said hydrogel components are treated using a diafiltration procedure to remove electroactive compounds therefrom.

15. The method of manufacturing of claim 1, wherein said hydrogel further comprises bisacrylamide.

16. The method of manufacturing 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.

17. The method of manufacturing of claim 16, 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.

18. The method of manufacturing of claim 17, 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.

19. The method of manufacturing of claim 1, wherein the collection assembly further comprises a second hydrogel having a first surface and a second surface, said second hydrogel comprising:

polyethylene oxide present in an amount of about 5% to about 20% by weight based on the total weight of the hydrogel;

water in an amount of about 50% or more and about 95% or less based on the total weight of the hydrogel;

a chloride salt, wherein a 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;

said inner face of the mask layer (i) is positioned in facing relationship with the first surface of the second hydrogel, and (ii) defines a second opening that exposes at least a portion of the first surface of the second hydrogel; and

said inner face of the gel retaining layer (i) is positioned in facing relationship with the second surface of the second hydrogel, and (ii) defines a second opening that exposes at least a portion of the second surface of the second hydrogel.