Integrated sensor for analyzing biological samples

• US 8,070,692 B2
• Filed: 08/04/2008
• Issued: 12/06/2011
• Est. Priority Date: 11/30/2005
• Status: Expired due to Fees

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories)
• Inventors: Ghesquiere, Alexander, Nicholls, Clive, Cabrall, John J, Matula, Scott A, Hector, Simon Andrew, Prieto, Javier, Petyt, Adrian, Chambers, Geoffrey Roger
• Primary Examiner(s): Hlndenburg, Max
• Assistant Examiner(s): Eiseman, Adam
• Application Number:
  US12/185,116
• Publication Number:
  US 20090159444A1
• Time in Patent Office: 1,219 Days
• Field of Search: 600/583, 600/584, 204/400, 204/403.01, 204/403.02, 204/403.03, 204/416, 606/181, 606/182
• US Class Current: 600/583
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• CPC Class Codes: A61B 5/150412 Pointed piercing elements, e.g. needles, lancets for piercing the skin blade-like piercing elements A61B5/150442
• CPC Class Codes: A61B 5/150519 Details of construction of hub, i.e. element used to attach the single-ended needle to a piercing device or sampling device
• CPC Class Codes: A61B 5/150564 Protectors removed by pulling or pushing
• CPC Class Codes: A61B 5/150572 Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
• CPC Class Codes: A61B 5/150702 fully automatically removed, i.e. the removing does not require any action by the user
• CPC Class Codes: A61B 5/150786 Optical identification systems, e.g. bar codes, colour codes
• CPC Class Codes: A61B 5/150793 Electrical or magnetic identification means
• CPC Class Codes: A61B 5/15132 comprising tooth-shaped elements, e.g. toothed wheel or rack and pinion
• CPC Class Codes: A61B 5/15153 Multiple piercing elements stocked in a single compartment
• CPC Class Codes: A61B 5/15174 Piercing elements stocked in the form of a stack or pile
• CPC Class Codes: A61B 5/15176 Stocking means comprising cap, cover, sheath or protection for aseptic stocking
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: C12Q 1/006 for glucose
• CPC Class Codes: G01N 33/48757 Test elements dispensed from a stack

Abstract

An integrated lancet and testing striplet for measuring a body analyte level in a health care regimen includes a skin piercing member and an analyte sensor coupled together.

Claims

1. An integrated analyte lancing and testing strip for measuring a body analyte-level, comprising:

a lancet needle; and

a test strip coupled to the lancet needle, the test strip and lancet needle on opposite ends of the integrated analyte lancing and testing strip, the test strip comprising;

a base;

a cover;

multiple electrodes including a working electrode applied to a first major surface of the cover;

a sample receiving portion of the test strip at an end opposite the lancet needle;

electrical contacts on a second major surface of the cover between the sample receiving portion of the test strip and the lancet needle;

a layer of electrically conductive material applied to a major surface of the base;

a sample flow channel including assay chemistry for testing an analyte level of an applied body fluid; and

at least one layer of electrically conductive adhesive for adhering the base to the cover, wherein at least one electrical passageway exists from the first major surface to the second major surface of the cover;

wherein the integrated analyte lancing and testing strip is configured to flip such that the test strip receives body fluid at the lancing site.

2. The integrated analyte lancing and testing strip of claim 1, wherein the working electrode and a trigger electrode are positioned in said flow channel.

3. The integrated analyte lancing and testing strip of claim 1, wherein the test strip further comprises a layer of an electrically conductive material applied to the first major surface of the cover.

4. The integrated analyte lancing and testing strip of claim 1, wherein said working electrode comprises carbon.

5. The integrated analyte lancing and testing strip of claim 4, further comprising a trigger electrode.

6. The integrated analyte lancing and testing strip of claim 5, wherein the trigger electrode comprises carbon.

7. The integrated analyte lancing and testing strip of claim 1, wherein the test strip is configured to analyze the analyte in a volume of less than about 1 microliter of sample.

8. The integrated analyte lancing and testing strip of claim 1, wherein the test strip is configured to analyze the analyte in a volume of less than about 0.5 microliter of sample.

9. The integrated analyte lancing and testing strip of claim 1, wherein the test strip is configured to analyze the analyte in a volume of less than about 0.2 microliter of sample.

10. The integrated analyte lancing and testing strip of claim 1, wherein the analyte comprises glucose.

11. An integrated analyte lancing and testing strip for measuring a body analyte level, comprising:

a lancet needle; and

a test strip coupled to the lancet needle, the test strip and lancet needle on opposite ends of the integrated analyte lancing and testing strip, the test strip comprising;

a base;

a cover;

multiple electrodes including a working electrode and a trigger electrode applied to a first major surface of the cover;

a sample receiving portion of the test strip at an end opposite the lancet needle;

electrical contacts on a second major surface of the cover between the sample receiving portion of the test strip and the lancet needle;

a layer of electrically conductive material applied to a major surface of the base;

a sample flow channel including assay chemistry for testing an analyte level of an applied body fluid;

at least one layer of adhesive for adhering the base to the cover; and

one or more electrically conductive vias defined in the cover and forming an electrical passageway from the first major surface to the second major surface of the cover;

wherein the integrated analyte lancing and testing strip is configured to flip such that the test strip receives body fluid at the lancing site.

12. The integrated analyte lancing and testing strip of claim 11, wherein the analyte comprises glucose.

13. The integrated analyte lancing and testing strip of claim 11, wherein the working electrode and a trigger electrode are positioned in said flow channel.

14. The integrated analyte lancing and testing strip of claim 11, wherein the test strip further comprises a layer of an electrically conductive material applied to the first major surface of the cover.

15. The integrated analyte lancing and testing strip of claim 11, wherein said working electrode comprises carbon.

16. The integrated analyte lancing and testing strip of claim 15, wherein the test strip further comprises a trigger electrode comprising carbon.