Multi-layer pad and methods of using the same

• US 9,993,202 B2
• Filed: 05/30/2007
• Issued: 06/12/2018
• Est. Priority Date: 05/30/2007
• Status: Active Grant

• Current Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Original Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Inventors: Zhu, Boru, Rebec, Mihailo V., Burson, Pamela J.
• Primary Examiner(s): BERHANU, ETSUB D
• Application Number:
  US12/600,403
• Publication Number:
  US 20100206746A1
• Time in Patent Office: 4,031 Days
• Field of Search: 600316, 600345, 600347, 600365
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157 disposable multilayered or laminated electrodes G01N27/307; details of handling chemical test elements G01N33/4875
• CPC Class Codes: A61B 5/1451 for interstitial fluid
• 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 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/6833 Adhesive patches
• CPC Class Codes: C12N 11/10 the carrier being a carbohydrate
• CPC Class Codes: C12N 9/0006 acting on CH-OH groups as donors (1.1)
• CPC Class Codes: C12Q 1/001 Enzyme electrodes
• CPC Class Codes: C12Q 1/006 for glucose
• CPC Class Codes: G01N 33/525 Multi-layer analytical elements

Abstract

A multi-layer pad that is adapted to be used in determining an analyte concentration is disclosed. The multi-layer pad includes a first layer, a second layer, and a third layer. The first layer includes an enzyme wherein the enzyme is adapted to assist in determining the analyte concentration. The second layer is attached to a first surface of the first layer. The second layer is made of a skin-conforming material. The third layer is attached to a second surface of the first layer wherein the first layer is located between the second layer and the third layer. It is contemplated that the multi-layer pad may also be a two layer system.

Claims

1. A multi-layer pad adapted to be used in determining an analyte concentration, the pad comprising:

a first layer including an enzyme, the first layer comprising material selected from the group consisting of fabric, porous membrane, and paper material, the enzyme being adapted to assist in determining the analyte concentration; and

a second layer being chemically cross-linked to the first layer, the second layer being made of a skin-conforming material.

2. The pad of claim 1, wherein the skin-conforming material comprises a hydrogel.

3. The pad of claim 1, wherein the skin-conforming material is a cross-linked hydrophilic polymer.

4. The pad of claim 1, wherein the enzyme is physically absorbed on or in the selected material.

5. The pad of claim 1, wherein the enzyme is chemically immobilized in the selected material.

6. The pad of claim 1, wherein the enzyme is glucose oxidase or glucose dehydrogenase.

7. The pad of claim 1, further comprising a third layer in which the first layer is located between the second layer and third layer, the second and the third layers being chemically cross-linked to the first layer.

8. The pad of claim 1, wherein the first layer comprises a layer of porous membrane including cellulose, cellulose derivatives, nylon, polyacrylonitrile, polycarbonate, polypropylene, polysulfone, or polyvinyl chloride.

9. The pad of claim 1, wherein the first layer comprises a layer of paper material.

10. The pad of claim 9, wherein the paper material includes cellulose or cellulose derivatives.

11. The pad of claim 1, wherein the first layer comprises a layer of fabric and the enzyme is added to the fabric.

12. The pad of claim 11, wherein the fabric includes silk, cellulose, polyethylene terephtalate, polyurethane, or glass fibers.

13. A method of continuously determining an analyte concentration, the method comprising the acts of:

providing a multi-layer pad comprising a first layer and a second layer, the second layer being chemically cross-linked to the first layer, the first layer including an enzyme, the first layer comprising material selected from the group consisting of fabric, porous membrane, and paper material, the enzyme being adapted to assist in determining the analyte concentration, the second layer being made of a skin-conforming material;

providing a sensor that is adapted to assist in determining the analyte concentration;

placing the multi-layer pad on skin, the multi-layer pad being located between the sensor and the skin; and

determining the analyte concentration.

14. The method of claim 13, wherein the sensor is an electrochemical sensor.

15. The method of claim 13, wherein the multi-layer pad further comprises the first layer being located between the second layer and the third layer, the third layer being chemically cross-linked to the first layer.

16. The method of claim 13, wherein the first layer comprises a layer of porous membrane including cellulose, cellulose derivatives, nylon, polyacrylonitrile, polycarbonate, polypropylene, polysulfone, or polyvinyl chloride.

17. The method of claim 13, wherein the first layer comprises a layer of paper material including cellulose or cellulose derivatives or the first layer is a layer of fabric including silk, cellulose, polyethylene terephtalate, polyurethane, or glass fibers.

18. An electrochemical sensor system comprising:

an electrochemical sensor having at least a counter electrode and a working electrode; and

a multi-layer pad coupled to the electrochemical sensor, the multi-layer pad comprising a first layer and a second layer, the second layer being chemically cross-linked to the first layer, the second layer being biocompatible for skin contact, the first layer including an enzyme, the first layer comprising material selected from the group consisting of fabric, porous membrane, and paper material, the enzyme being adapted to assist in determining the analyte concentration,

wherein the multi-layer pad is attached to the electrochemical sensor.

19. The system of claim 18, wherein the first layer comprises a layer of porous membrane including cellulose, cellulose derivatives, nylon, polyacrylonitrile, polycarbonate, polypropylene, polysulfone, or polyvinyl chloride.

20. The system of claim 18, wherein the first layer comprises a layer of paper material including cellulose or cellulose derivatives or the first layer is a layer of fabric including silk, cellulose, polyethylene terephtalate, polyurethane, or glass fibers.