Integrated sensor for analyzing biological samples

• US 8,066,649 B2
• Filed: 08/04/2008
• Issued: 11/29/2011
• 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: Nicholls, Clive, Chambers, Geoffrey Roger, Matula, Scott A, Cabrall, John J, Prieto, Javier, Ghesquiere, Alexander, Petyt, Adrian, Hector, Simon Andrew
• Primary Examiner(s): Hindenburg; Max
• Assistant Examiner(s): Eiseman; Adam
• Application Number:
  US12/185,117
• Publication Number:
  US 20090143700A1
• Time in Patent Office: 1,212 Days
• Field of Search: 600/573, 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. A method of providing a sample of body fluid to a test strip for measuring an analyte level within the fluid, comprising:

providing an integrated lancing and testing strip including a lancet needle and a test strip that are coupled at opposite ends of a lancet body of the integrated lancing and testing strip, the test strip having a flat substrate including first and second major surfaces and edge surfaces, wherein the first and second major surfaces are larger than the edge surfaces, and wherein the first major surface faces a first orthogonal direction;

loading the integrated lancing and testing strip within an analyte meter including arming the lancet needle by removing a lancet cap;

piercing a lancing site with the lancet needle at a predetermined location relative to the meter; and

automatically reorienting the integrated lancing and testing strip within the analyte meter such that the first major surface faces a second orthogonal direction; and

automatically advancing and contacting a sample receiving portion of the test strip at the lancing site, such that body fluid from the lancing site is automatically applied to the sample receiving portion of the test strip for measuring an analyte level.

2. The method of claim 1, further comprising disarming the lancet needle and disposing of the integrated lancing and testing strip.

3. The method of claim 1, wherein the lancing site remains approximately at said predetermined location relative to the meter when body fluid is applied to the sample receiving portion of the test strip.

4. The method of claim 1, wherein the loading comprises mating a first recess defined within the lancet body with a latching mechanism of the analyte meter, such that the integrated lancing and testing strip is specifically disposed at a lancing orientation.

5. The method of claim 4, wherein the flipping comprises mating a second recess defined within the lancet body with the same latching mechanism, such that the integrated lancing and testing strip is specifically disposed at a testing orientation.

6. The method of claim 5, wherein each of said pair of recesses comprises a trapezoidal shape.

7. The method of claim 6, wherein the loading comprises mating a first recess defined within the lancet body with a spring-loaded ball and detent mechanism of the analyte meter, such that the integrated lancing and testing strip is specifically disposed at a lancing orientation.

8. The method of claim 7, wherein the flipping comprises mating a second recess defined within the lancet body with the same ball and detent mechanism, such that the integrated lancing and testing strip is specifically disposed at a testing orientation.

9. The method of claim 1, wherein the lancing site remains approximately at said predetermined location relative to the meter when body fluid is applied to the sample receiving portion of the test strip, and wherein the test strip and lancet are symmetrically disposed at opposite ends of the lancet body.

10. The method of claim 9, wherein the loading comprises mating a first recess defined within the lancet body with a ball and detent mechanism of the analyte meter, such that the integrated lancing and testing strip is specifically disposed at a lancing orientation.

11. The method of claim 10, wherein the flipping further comprises mating a second recess defined within the lancet body symmetrically opposite the first recess with the same ball and detent mechanism, such that the integrated lancing and testing strip is specifically disposed at a testing orientation.

12. The method of claim 11, wherein the loading comprises mating a first recess defined within the lancet body with a latching mechanism of the analyte meter, such that the integrated lancing and testing strip is specifically disposed at a lancing orientation.

13. The method of claim 12, wherein the flipping further comprises mating a second recess defined within the lancet body symmetrically opposite the first recess with the same latching mechanism, such that the integrated lancing and testing strip is specifically disposed at a testing orientation.

14. The method of claim 1, wherein the arming comprises uncoupling a lancet cap by uncoupling one or more elastomeric arms of the lancet cap from defined cutouts in the lancet body by application of sufficient separating force.

15. The method of claim 14, further comprising disarming the lancet needle, including snapping the one or more elastomeric arms of the lancet cap back into mating relationship with the defined cutouts of the lancet body by application of sufficient coupling force.

16. The method of claim 1, further comprising coupling at least one tooth that fits a corresponding slot, and rotationally stabilizing the test strip relative to the lancet body, for coupling the lancet body and test strip together.

17. The method of claim 1, further comprising coupling at least two teeth that fit corresponding slots for coupling the lancet body and test strip together.

18. The method of claim 17, wherein the lancet body comprises said teeth and the test strip comprises said corresponding slots.