INTEGRATED LANCET AND TEST STRIP AND METHODS OF MAKING AND USING SAME

• US 20110040208A1
• Filed: 08/11/2009
• Published: 02/17/2011
• Est. Priority Date: 08/11/2009
• Status: Abandoned Application

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories)
• Inventors: MCMINN, Daniel R., Yahnke, Mark S.
• Application Number:
  US12/539,483
• Publication Number:
  US 20110040208A1
• Time in Patent Office: Days
• US Class Current: 600/583
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150213 Venting means
• CPC Class Codes: A61B 5/150274 Manufacture or production processes or steps for blood sampling devices
• 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 5/150618 Integrally moulded protectors, e.g. protectors simultaneously moulded together with a further component, e.g. a hub, of the piercing element
• 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 5/1513 comprising linear sliding guides comprising tooth-shaped elements A61B5/15132
• 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 5/157 Devices characterised by integrated means for measuring characteristics of blood

Abstract

An integrated lancet and test strip for measuring an analyte level is provided. The test strip includes a protrusion at a sample receiving end of the test strip, and a notch at a body receiving end of the test strip. Further, a method of measuring an analyte level in a sample of bodily fluid using the integrated lancing and testing meter is also provided. Still further, a method of making a plurality of test strips for use in an integrated lancet and test strip is also provided.

Claims

1. An integrated lancet and test strip for measuring an analyte level, comprising:

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

a lancet needle coupled to the lancet end of the body; and

a test strip coupled to the test strip receiving end of the body, wherein the test strip comprises;

multiple electrodes and assay chemistry for determining an analyte level in a sample;

a protrusion at a sample receiving end of the test strip; and

a body receiving end of the test strip;

wherein the test strip and lancet needle are configured such that the test strip is not in fluid communication with the lancet needle.

2. The integrated lancet and test strip of claim 1, wherein the test strip further comprises a notch at the body receiving end of the test strip, and wherein the shape of the notch and protrusion are substantially triangular.

3. The integrated lancet and test strip of claim 1, wherein the test strip further comprises a notch at the body receiving end of the test strip, and wherein the notch comprises a shape different than a shape of the protrusion at the sample receiving end of the test strip.

4. The integrated lancet and test strip of claim 1, wherein the test strip further comprises a notch at the body receiving end of the test strip, and wherein the notch comprises a shape substantially the same as a shape of the protrusion at the sample receiving end of the test strip.

5. The integrated lancet and test strip of claim 4, wherein the test strip further comprises a notch at the body receiving end of the test strip, and wherein the shape of the notch and protrusion are one selected from the group consisting of substantially triangular, substantially semi-circular, and substantially rectangular.

6. The integrated lancet and test strip of claim 1, wherein the body receiving end of the test strip is opposite the fluid receiving end of the test strip.

7. The integrated lancet and test strip of claim 1, wherein the test strip further comprises a notch at the body receiving end of the test strip, and wherein a location of the notch along the body receiving end corresponds to a location of the protrusion along the sample receiving end.

8. The integrated lancet and test strip of claim 7, wherein the test strip further comprises a notch at the body receiving end of the test strip, and wherein the location of the notch is in a side region of the body receiving end, and the location of the protrusion is in a side region of the sample receiving end.

9. The integrated lancet and test strip of claim 1, wherein the test strip further comprises a notch at the body receiving end of the test strip, and wherein a location of the notch along the body receiving end is offset from a location of the protrusion along the sample receiving end.

10. The integrated lancet and test strip of claim 9, wherein the test strip further comprises a notch at the body receiving end of the test strip, and wherein the location of the notch is in a center region of the body receiving end, and the location of the protrusion is outside of a center region of the sample receiving end.

11. The integrated lancet and test strip of claim 1, wherein the test strip further comprises a channel extending from the sample receiving end to the body receiving end of the test strip, wherein the protrusion is located entirely on one side of a bisecting line of the channel.

12. The integrated lancet and test strip of claim 1, wherein the test strip further comprises:

a notch at the body receiving end of the test strip; and

a channel extending from the sample receiving end to the body receiving end of the test strip, wherein a peak point of the protrusion and a peak point of the notch align within a width of the channel.

13. The integrated lancet and test strip of claim 12, wherein the peak point of the protrusion aligns to one side of a bisecting line of the channel.

14. The integrated lancet and test strip of claim 13, wherein the protrusion comprises a substantially triangular shape.

15. The integrated lancet and test strip of claim 13, wherein the test strip further comprises a notch at the body receiving end of the test strip, and wherein the peak point of the notch aligns on the bisecting line of the channel.

16. The integrated lancet and test strip of claim 13, wherein the peak point of the protrusion aligns closer to a first side of the channel than to the bisecting line of the channel.

17. The integrated lancet and test strip of claim 13, wherein the test strip further comprises:

a first and second adhesive strip extending on a first and second side of the channel, respectively, and defining the channel.

18. The integrated lancet and test strip of claim 17, wherein the peak point of the protrusion aligns closer to the first adhesive strip than to the bisecting line of the channel.

19. The integrated lancet and test strip of claim 17, wherein a shape of the protrusion is one selected from the group consisting of substantially triangular, substantially semi-circular, and substantially rectangular.

20. The integrated lancet and test strip of claim 17, wherein the test strip further comprises a notch at the body receiving end of the test strip, and wherein the peak point of the notch aligns on the bisecting line of the channel.

21. The integrated lancet and test strip of claim 1, wherein the test strip further comprises:

a channel extending from the sample receiving end to the body receiving end of the test strip, the channel defined by a first and second structure on each side of the channel, the first structure providing structural rigidity to the protrusion.

22. The integrated lancet and test strip of claim 21, wherein the first and second structure are adhesive strips.

23. The integrated lancet and test strip of claim 1, wherein at least one of the multiple electrodes comprises an analyte response enzyme.

24. The integrated lancet and test strip of claim 23, wherein the analyte response enzyme is a glucose response enzyme or a ketone responsive enzyme.

25-103. -103. (canceled)