Test strip with integrated lancet

• US 20080208078A1
• Filed: 02/28/2007
• Published: 08/28/2008
• Est. Priority Date: 02/28/2007
• Status: Active Grant

• Current Assignee: Trividia Health, Inc. (Sinocare, Inc.)
• Original Assignee: Home Diagnostics Incorporated
• Inventors: Caban, Allan Javier, Neel, Gary
• Granted Patent: US 8,636,672 B2
• Time in Patent Office: Days
• 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 5/1411 by percutaneous method, e.g. by lancet
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/15019 Depth adjustment mechanism using movable stops located inside the piercing device housing and limiting the travel of the drive mechanism mechanisms using distal end caps A61B5/150183, mechanisms at the piercing element carrier proximal end A61B5/150198
• CPC Class Codes: A61B 5/150282 for piercing elements, e.g. blade, lancet, canula, needle
• 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 5/150435 Specific design of proximal end
• CPC Class Codes: A61B 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• CPC Class Codes: A61B 5/150572 Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
• CPC Class Codes: A61B 5/15107 Piercing being assisted by a triggering mechanism
• CPC Class Codes: A61B 5/15117 comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
• CPC Class Codes: A61B 5/15123 comprising magnets or solenoids
• CPC Class Codes: A61B 5/1519 comprising driving means, e.g. a spring, for propelling the piercing unit
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood

Abstract

The present disclosure provides methods and systems to collect blood from a patient using a lancet integrated with a test strip. The present disclosure provides integrated test strips having an integrated lancet, as well as meters for actuating the lancet integrated within a test strip. The analyte test strip comprises a first test strip substrate material and a second test strip substrate material. At least one test strip substrate material comprises an elongate cavity. The test strip further comprises a reaction test site for testing analyte concentrations in blood. The test strip further comprises at least one opening communicating with the at least one cavity.

Claims

1. An analyte test strip comprising:

a first test strip substrate;

a second test strip substrate;

an elongate cavity extending through at least one of the first substrate and the second substrate;

a lancet disposed in the at least one elongate cavity;

an opening disposed at one end of the test strip and communicating with the at least one cavity; and

a reaction test site.

2. The test strip of claim 1, wherein the lancet comprises at least one of a biocompatible plastic and a biocompatible metal.

3. The test strip of claim 1, wherein the lancet comprises a first, sharp end and a second end opposite the sharp end configured to engage an actuation mechanism of an analyte meter.

4. The test strip of claim 1, wherein the reaction test site comprises one or more enzymes selected to facilitate a reaction with glucose.

5. The test strip of claim 4, wherein the one or more enzymes comprise at least one of glucose oxidase and glucose dehydrogenase.

6. The test strip of claim 1, further including a material covering the opening to fluidly seal the cavity.

7. The test strip of claim 6, wherein the covering is comprised of a thin film.

8. The test strip of claim 7, wherein the thin film is comprised of a polymer.

9. The test strip of claim 7, wherein the thin film is comprised of a latex.

10. The test strip of claim 7, wherein the thin film is comprised of a polyethylene.

11. An analyte meter for monitoring a characteristic of a sample of blood, comprising:

a test strip interface for engaging a first end of a test strip, the test strip including;

a first test strip substrate;

a second test strip substrate;

an elongate cavity extending through a portion of one of the first substrate and the second substrate;

a lancet disposed in the at least one elongate cavity;

an opening disposed at one end of the test strip and communicating with the at least one cavity;

a reaction test site;

an actuation mechanism configured to engage one end of the lancet and to advance a second sharp end of the lancet through the opening of the test strip; and

a meter for measuring the concentration of an analyte in a sample of blood.

12. The analyte meter of claim 11, wherein the actuation mechanism comprises a spring.

13. The analyte meter of claim 11, wherein the actuation mechanism comprises a motor.

14. The analyte meter of claim 11, wherein the lancet comprises a mechanism for adjusting the depth of penetration of the lancet.

15. A method of producing a test strip having an integrated lancet, comprising:

selecting a first test strip substrate;

selecting a second test strip substrate;

forming an elongate cavity in at least one of the first test strip substrate or second test strip substrate;

selecting a lancet body having at least one sharp end;

positioning the lancet body in the at least one elongate cavity; and

attaching the first and second substrates to one another.

16. The method of claim 15, wherein forming the at least one elongate cavity comprises forming the cavity using a laser.

17. The method of claim 15, wherein forming the at least one elongate cavity comprises forming the cavity using a pressurized water-jet cutter.

18. The method of claim 15, wherein forming the at least one elongate cavity comprises forming the cavity using a chemical.

19. The method of claim 15, wherein forming at least one elongate cavity comprises forming the cavity using a saw or a cutting tool.

20. The method of claim 15, further including sterilizing the lancet before positioning the lancet in the at least one elongate cavity.

21. The method of claim 20, wherein sterilizing the lancet includes autoclaving the lancet.

22. The method of claim 20, wherein sterilizing the lancet includes exposing the lancet to radiation.

23. The method of claim 20, wherein sterilizing the lancet includes using ethylene oxide.

24. The method of claim 20, wherein sterilizing the lancet includes using ethyl alcohol.

25. The method of claim 15, further including sterilizing the test strip and integrated lancet after the lancet is disposed in the cavity of the test strip.

26. The method of claim 25, wherein sterilizing the test strip and integrated lancet includes autoclaving.

27. The method of claim 25, wherein sterilizing the test strip and integrated lancet includes using radiation.

28. The method of claim 25, wherein sterilizing the test strip and integrated lancet includes using ethylene oxide.

29. The method of claim 25, wherein sterilizing the test strip and integrated lancet includes using ethyl alcohol.

30. The method of claim 15, wherein the first and second substrates can be attached to another using any of a number of glues, epoxies, nails, pins, or screws.