Integrated sensor for analyzing biological samples

• US 8,105,245 B2
• Filed: 08/04/2008
• Issued: 01/31/2012
• 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, 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 JARED
• Application Number:
  US12/185,118
• Publication Number:
  US 20090143701A1
• Time in Patent Office: 1,275 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. An integrated lancing and testing kit for measuring a body analyte level, comprising:

a meter for analyzing the analyte to determine the body analyte level;

a cartridge containing one or more integrated lancet and testing strips; and

wherein the one or more integrated testing strips each comprise;

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 an analyte level of an applied body fluid, wherein the contacts for electrically coupling to the meter are disposed on a surface 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 ends of the integrated lancet and testing strip 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 the integrated lancet and testing strip into the meter, reorienting the integrated lancet and testing strip within the meter, and re-advancing the integrated lancet and testing strip.

2. The integrated lancing and testing kit 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 lancing and testing kit 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 the integrated lancet and testing strip into the meter, re-orienting the integrated lancet and testing strip within the meter, and re-advancing the integrated lancet and testing strip.

4. The integrated and testing kit of claim 3, wherein the reorienting comprises rotating the integrated lancet and testing strip with the meter.

5. The integrated lancing and testing kit of claim 1, wherein the reorienting comprises flipping approximately 180 degrees.

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

7. The integrated lancing and testing kit 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 lancing/testing site.

8. The integrated lancing and testing kit of claim 1, further comprising a lancet cap for securing the protruding lancet needle.

9. The integrated lancing and testing kit of claim 8, 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.

10. The integrated lancing and testing kit of claim 1, further comprising a lancet cap securing the lancet before or after use, or both.