Integrated sensor for analyzing biological samples

• US 8,652,068 B2
• Filed: 01/03/2012
• Issued: 02/18/2014
• Est. Priority Date: 11/30/2005
• Status: Expired due to Fees

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Ghesquiere, Alexander G., Nicholls, Clive, Cabrall, John J., Matula, Scott A., Hector, Simon Andrew, Prieto, Javier, Petyt, Adrian, Chambers, Geoffrey Roger
• Primary Examiner(s): Hoekstra, Jeffrey G
• Assistant Examiner(s): EISEMAN, ADAM JARED
• Application Number:
  US13/342,677
• Publication Number:
  US 20120238850A1
• Time in Patent Office: 777 Days
• Field of Search: 600/573, 600575-579, 600/583, 600/584, 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 disposable multilayered or laminated electrodes G01N27/307; details of handling chemical test elements G01N33/4875
• 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 lancet and testing strip for measuring a body analyte level, comprising:

a flat lancet body having a top side, a bottom side opposite the top side, a test strip receiving end, and a lancet receiving end opposite the test strip receiving end, wherein the test strip receiving end comprises a first protruding arm spaced apart from a second protruding arm, the first protruding arm and the second protruding arm forming an opening on the top side of the lancet body, the opening flanked by the first and second protruding arms;

a lancet needle protruding from the lancet end of the lancet body; and

a test strip coupled to the test strip receiving end of the lancet body and disposed between the first and second protruding arms, the test strip comprising;

multiple electrodes and assay chemistry for testing the body analyte level of an applied body fluid;

contacts for electrically coupling to a meter disposed on a surface of the test strip at the test strip receiving end of the lancet body, wherein the contacts are disposed on the test strip between the first and second protruding arms such that the contacts are exposed through the opening on the top side of the lancet body; and

a sample receiving portion disposed at a distal edge of the test strip such that the sample receiving portion is at an opposite end of integrated lancet and test strip than the lancet needle;

wherein the integrated lancet and testing strip is configured for lancing and application of body fluid at a lancing site by automatically lancing, withdrawing, reorienting and re-advancing the integrated lancet and testing strip.

2. The integrated lancet and testing strip of claim 1, wherein the test strip is coupled to the test strip receiving end of the lancet body such that a first portion of the test strip is disposed between the first and second protruding arms and a second portion of the test strip is disposed outside the first and second protruding arms of the lancet body, and wherein the sample receiving portion is disposed on the second portion of the test strip.

3. The integrated lancet and testing strip of claim 1, wherein test strip is disposed within L-shaped grooves in the first and second protruding arms.

4. The integrated lancet and testing strip of claim 1, wherein the test strip comprises first and second openings to secure the test strip to the lancet body.

5. The integrated lancet and testing strip of claim 4, wherein the first opening in the test strip secures to a first tab of the first protruding arm of the lancet body, and the second opening in the test strip secures to a second tab of the second protruding arm of the lancet body.

6. The integrated lancet and testing strip of claim 4, wherein the first opening in the test strip secures to a first tab on the lancet body, and the second opening in the test strip secures to a second tab on the lancet body, wherein the first tab and the second tab are disposed on the bottom side of the lancet body in facing relation to the opening in the top side of the lancet body.

7. The integrated lancet and testing strip of claim 1, wherein the lancet needle and test strip are separated such as not to be in fluid communication with regard to the body fluid.

8. The integrated lancet and testing strip of claim 1, wherein the lancet body comprises a pair of relatively disposed recesses for respectively positioning the test strip for lancing and application of body fluid at said same lancing/testing site.

9. The integrated lancet and testing strip of claim 8, wherein each of said pair of recesses comprises a substantially trapezoidal shape.

10. The integrated lancet and testing strip of claim 8, wherein the recesses are configured for coupling with a spring-loaded ball and detent mechanism.

11. The integrated lancet and testing strip of claim 8, wherein the recesses are configured for coupling with a latching mechanism.

12. The integrated lancet and testing strip of claim 1, further comprising a lancet cap for securing the protruding lancet needle.

13. The integrated lancet and testing strip of claim 1, wherein the test strip comprises a base and a cover.

14. The integrated lancet and testing strip of claim 13, wherein the cover has a working electrode applied to one or more major surfaces thereof.

15. The integrated lancet and testing strip of claim 14, further comprising a trigger electrode.

16. The integrated lancet and testing strip of claim 15, wherein the sample receiving portion comprises a recess formed in an edge of the base or the cover, or both.

17. The integrated lancet and testing strip of claim 16, wherein the recess has a hydrophilic material applied thereto.

18. The integrated lancet and testing strip of claim 16, wherein said lancet needle is positioned approximately 180°

from said recess.