Integrated sensor for analyzing biological samples

• US 8,105,244 B2
• Filed: 09/28/2006
• Issued: 01/31/2012
• 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): Hindenburg, Max
• Assistant Examiner(s): EISEMAN, ADAM JARED
• Application Number:
  US11/535,986
• Publication Number:
  US 20070149897A1
• Time in Patent Office: 1,951 Days
• Field of Search: 600/573, 600/575, 600/576, 600/577, 600/578, 600/579, 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
• 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, the strip comprising:

a lancet body including a test strip receiving end and a lancet end;

a lancet needle coupled with, protruding from, and fixed relative to the lancet end of the lancet body;

a test strip coupled to the test strip receiving end of the lancet body having multiple electrodes and assay chemistry for testing the body analyte level of an applied body fluid, wherein the contacts for electrically coupling to a meter are disposed on a surfaced of the test strip at the test strip receiving end of the lancet body;

wherein the test strip and lancet needle are relatively disposed at different end of the lancet body for providing both lancing and application of body fluid at a lancing site, the test strip including a sample receiving portion at an end opposite the lancet needle, and wherein the contacts are between the sample receiving portion and the lancet needle; and

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 lancet needle and test strip are separated such as not to be in fluid communication with regard to the body fluid.

3. The integrated lancet and testing strip of claim 2, wherein the lancet needle and test strip are separated sufficiently that test strip is out of reach of spreading analyte prior to withdrawing, re-orienting and re-advancing the integrated lancet and testing strip.

4. The integrated lancet and testing strip of claim 1, wherein the reorienting comprises rotating the integrated lancet and testing strip.

5. 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.

6. The integrated lancet and testing strip of claim 5, wherein each of said pair of recesses comprises a substantially trapezoidal shape.

7. The integrated lancet and testing strip of claim 5, wherein the recesses are configured for coupling with a spring-loaded ball and detent mechanism.

8. The integrated lancet and testing strip of claim 5, wherein the recesses are configured for coupling with a latching mechanism.

9. The integrated lancet and testing strip of claim 1, wherein the reorienting comprises flipping approximately 180 degrees.

10. The integrated lancet and testing strip of claim 1, wherein the test strip and lancet are symmetrically disposed at opposite ends of the lancet body.

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

12. The integrated lancet and testing strip of claim 11, wherein the lancet cap comprises one or more elastomeric arms that couple with defined cutouts in the lancet body for snapping the cap into and out of mating relationship with the lancet body by respective application of sufficient coupling and separation force.

13. The integrated lancet and testing strip of claim 1, wherein the lancet body and test strip comprise at least one tooth that fits a corresponding slot, along with a mechanism for rotationally stabilizing the test strip relative to the lancet body, for coupling the lancet body and test strip together.

14. The integrated lancet and testing strip of claim 13, wherein the lancet body and test strip comprise at least two teeth that fit corresponding slots for coupling the lancet body and test strip together with rotational stability.

15. The integrated lancet and testing strip of claim 14, wherein the lancet body comprises said teeth and the test strip comprises said corresponding slots.

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

17. The integrated lancet and testing strip of claim 16, wherein the base has at least one layer of electrically conductive material applied to one or more major surfaces thereof.

18. The integrated lancet and testing strip of claim 16, wherein the cover has a working electrode applied to one or more major surfaces thereof.

19. The integrated lancet and testing strip of claim 18, further comprising a trigger electrode.

20. The integrated lancet and testing strip of claim 16, wherein the base is adhered to the cover by at least one layer of adhesive.

21. The integrated lancet and testing strip of claim 20, wherein said at least one layer of adhesive is a layer of electrically conductive adhesive.

22. The integrated lancet and testing strip of claim 20, wherein said at least one layer of adhesive is a layer of non-conductive adhesive.

23. The integrated lancet and testing strip of claim 16, wherein the sensor-containing portion comprises a sample flow channel.

24. The integrated lancet and testing strip of claim 23, wherein the sensor-containing portion comprises a sample flow channel, and a working electrode is positioned in said flow channel.

25. The integrated lancet and testing strip of claim 24, wherein the flow channel has a volume of about 1 microliter or less.

26. The integrated lancet and testing strip of claim 24, wherein the flow channel has a volume of about 0.5 microliter or less.

27. The integrated lancet and testing strip of claim 24, wherein the flow channel has a volume of about 0.2 microliter or less.

28. The integrated lancet and testing strip of claim 16, wherein the cover comprises at least one electrical passageway running from an inner face to an outer face.

29. The integrated lancet and testing strip of claim 16, wherein the cover comprises at least one slot formed therein to attach the sensor-containing portion to at least one tab in the lancet-containing body.

30. The integrated lancet and testing strip of claim 16, wherein the base comprises at least one opening formed therein to attach the sensor-containing portion to at least one tab in the lancet-containing body.

31. The integrated lancet and testing strip of claim 16, wherein the base or the cover, or both, has a recess formed in an edge thereof that forms the sample receiving portion of the test strip.

32. The integrated lancet and testing strip of claim 31, wherein the recess has a hydrophilic material applied thereto.

33. The integrated lancet and testing strip of claim 31, wherein said lancet is positioned approximately 180°

from said recess.

34. The integrated lancet and testing strip of claim 33, wherein electrical contact pads are on at least one major surface of the cover.

35. The integrated lancet and testing strip of claim 33, wherein electrical contact pads are on at least one major surface of the base.

36. The integrated lancet and testing strip of claim 33, wherein the cover comprises a layer of an electrically conductive or semiconductive material or both.

37. The integrated lancet and testing strip of claim 36, wherein said working electrode comprises carbon.

38. The integrated lancet and testing strip of claim 19, wherein said trigger electrode comprises carbon.

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

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

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

42. The integrated lancet and testing strip of claim 1, further comprising a lancet cap for securing the lancet before or after use, or both.