MULTI-LAYER PAD AND METHODS OF USING THE SAME

• US 20100206746A1
• Filed: 05/30/2007
• Published: 08/19/2010
• Est. Priority Date: 05/30/2007
• Status: Active Grant

• Current Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Original Assignee: Bayer Healthcare LLC (Bayer AG)
• Inventors: Zhu, Boru, Rebec, Mihailo V., Burson, Pamela J.
• Granted Patent: US 9,993,202 B2
• Time in Patent Office: Days
• US Class Current: 205/777.500
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157
• 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 enzyme being adapted to assist in determining the analyte concentration; and

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

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 hydrophillic polymer.

5. The pad of claim 1, wherein the first layer further includes fabric, porous membrane, or paper material.

6. The pad of claim 5, wherein the enzyme is physically absorbed on or in the fabric, porous membrane, or paper material.

7. The pad of claim 5, wherein the enzyme is chemically immobilized in the fabric, porous membrane, or paper material.

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

10. 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.

4. (canceled)

9. (canceled)

11-18. -18. (canceled)

19. 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 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.

22. The method of claim 19, wherein the sensor is an electrochemical sensor.

29. The method of claim 19, wherein the multi-layer pad further comprises a third layer, the first layer being located between the second layer and the third layer, the third layer being chemically cross-linked to the first layer.

20-21. -21. (canceled)

23-28. -28. (canceled)

30-35. -35. (canceled)

36. An electrochemical sensor system comprising:

an electrochemical sensor having a 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 attached to the first 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 enzyme being adapted to assist in determining the analyte concentration,

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

37-39. -39. (canceled)

40. A method of making a multi-layer pad for use in determining an analyte concentration, the method comprising the acts of:

immersing a first layer of the multi-layer pad in a first solution including at least one enzyme, the first layer having a first surface and a second surface;

removing the first layer from the first solution;

drying the first layer such that the at least one enzyme is physically absorbed in the first layer;

after drying the first layer, applying a second solution to at least one of the first surface and the second surface of the first layer; and

chemically cross-linking the second solution to the first layer, the chemically cross-linked second solution forming at least one outer polymeric layer.

41. The method of claim 40, wherein the first layer includes a porous membrane, a fabric material, or a paper material.

42. The method of claim 40, wherein the second solution is a monomer solution or a polymer solution.

43. The method of claim 40, wherein the second solution is a gelatin solution.

44. The method of claim 40, wherein the chemically cross-linking further includes irradiating UV light onto the first layer to assist in chemically cross-linking the second solution to the first layer.

45. The method of claim 40, wherein the at least one outer polymeric layer includes a first polymeric outer layer and a second polymeric outer layer, the first layer being located between the first polymeric outer layer and the second polymeric outer layer.

46. The method of claim 40, wherein the first solution is a buffered solution.

47. The method of claim 40, wherein the first solution is a water-soluble solution.

48. The method of claim 40, wherein the at least one enzyme is glucose oxidase.

49. The method of claim 40, wherein the second solution includes at least one monomer, a cross linker, and a UV initiator.

50. The method of claim 49, wherein the at least one monomer is N-vinyl pyrrolidone and vinyl acetate, the cross linker is diethylene glycol divinyl ether, and the UV initiator is 2-hydroxy-4′

-(2-hydroxyethoxy)-2-methylpropiophenone.

51. The method of claim 40, further comprising after the act of applying the second solution, wrapping the first layer with a plastic film.