Multiple-biosensor article

• US 8,211,038 B2
• Filed: 09/17/2004
• Issued: 07/03/2012
• Est. Priority Date: 09/17/2004
• Status: Expired due to Fees

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Wang, Yi, Watkin, Jared Lee, Mace, Chad Harold, Zocchi, Michael Robert, Karinka, Shridhara Alva, Tess, Mark E.
• Primary Examiner(s): TOWA, RENE T
• Application Number:
  US10/944,302
• Publication Number:
  US 20060064035A1
• Time in Patent Office: 2,846 Days
• Field of Search: 600573-583, 435/4, 435/817, 204/403, 204/403.03, 204/409, 204/416, 204/418, 204/419
• US Class Current: 600/584
• 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 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: G01N 27/27 Association of two or more measuring systems or cells, each measuring a different parameter, where the measurement results may be either used independently, the systems or cells being physically associated, or combined to produce a value for a further parameter
• CPC Class Codes: G01N 27/3272 Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels optical biosensors G01N33/52
• CPC Class Codes: G01N 33/4875 Details of handling test elements, e.g. dispensing or storage, not specific to a particular test method test-elements per se B01L, automatic analysers G01N35/00, in-vivo analysis on the human body for medical diagnosis A61B

Abstract

An article suitable for conducting one or more assays with an apparatus, e.g., a meter, for determining the presence or concentration of an analyte in a sample of biological fluid. The article contains a plurality of biosensors arranged in such a manner that each of the biosensors can be utilized before the article must be removed from the apparatus.

Claims

1. An article for providing a plurality of test strips, said article comprising:

(a) a thin, flat plate comprising

     1) a sample receiving side and

     2) a backing-facing side that is opposite the sample receiving side;

wherein said thin, flat plate has a plurality of sectors, each of said sectors comprising;

an electrode arrangement applied thereto on the backing-facing side, and a first aperture for receiving a sample, wherein the electrode arrangement is adjacent the first aperture;

(b) a backing comprising

     1) a lancet-receiving side and

     2) a plate-facing side that is opposite the lancet-receiving side, wherein the plate-facing side faces the backing-facing side of the thin, flat plate;

wherein the backing has a plurality of sectors, each of said sectors having a recessed portion on the lancet-receiving side of the backing, the recessed portion comprising a wall portion and a base portion, and wherein the base portion includes a second aperture therethrough, wherein the wall portion is arranged and configured to guide a lancing device through the recessed portion and second aperture in from the lancet-receiving side and out the plate-facing side of the backing;

wherein the plate-facing side of the backing includes a flow channel extending from the second aperture along a major surface of the plate-facing side of the backing, and wherein the flow channel is in register with the second aperture and said electrode arrangement;

wherein said major surface of said plate-facing side of the backing is in facing orientation to the backing-facing side of said thin, flat plate such that the flow channel is on the plate-facing side of the backing and in facing arrangement with the electrode arrangement;

wherein said first aperture is in facing arrangement with said second aperture, said first aperture is in register with said second aperture in said base portion of said backing, wherein the electrode arrangement is disposed on the thin, flat plate adjacent to the first and second apertures;

wherein said lancing device passes first through the recessed portion of the lancet-receiving side of said backing and then through said second and first apertures out to the sample receiving side of the thin, flat plate.

2. The article of claim 1, wherein each of said first apertures in said thin, flat plate has a notch located on the periphery thereof.

3. The article of claim 1, wherein one major surface of said thin, flat plate is adhered to said major surface of said backing comprising said second aperture.

4. The article of claim 3, wherein a layer of adhesive adheres said one major surface of said thin, flat plate to said major surface of said backing, said layer of adhesive comprising a plurality of channels for the transport of biological fluid from the skin of a patient to said electrode arrangements.

5. The article of claim 1, wherein said thin, flat plate has a central opening and said backing has a central opening.

6. The article of claim 1, wherein the major surfaces of said thin, flat plate and said backing are circular in shape.

7. The article of claim 6, wherein said article is advanced by rotating said article.

8. The article of claim 1, further including a plurality of alignment posts for ensuring that said first aperture in said thin, flat plate is in register with said second aperture in said recessed portion in said backing.

9. The article of claim 1, wherein said backing is attached to said thin, flat plate by means of press-fitting.

10. The article of claim 1, wherein said backing is attached to said thin, flat plate by means of a weld.

11. The article of claim 1, wherein each electrode arrangement comprises a working electrode and a second electrode.

12. The article of claim 11, wherein the second electrode is a counter electrode and said electrode arrangement further comprises a reference electrode.

13. The article of claim 12, wherein said counter electrode functions as a trigger electrode.

14. The article of claim 1, wherein said first and second apertures are circular in shape.

15. The article of claim 1, wherein said thin, flat plate and said backing are made of polymeric material.

16. The article of claim 1, wherein said flow channel includes a mesh.

17. The article of claim 1, wherein said flow channel has a volume ranging from 0.1 to 4 μ

L.

18. The article of claim 1, further comprising a plurality of lancets.

19. The article of claim 18, wherein said plurality of lancets comprises a head and a blade.

20. The article of claim 1, wherein said electrode arrangement comprises a working electrode and a dual-purpose reference/counter electrode.

21. The article of claim 1, wherein said article is used for a glucose assay.