Test strip device and related methods thereof

• US 10,154,809 B2
• Filed: 06/24/2016
• Issued: 12/18/2018
• Est. Priority Date: 06/24/2015
• Status: Active Grant

• Current Assignee: University of Virginia Patent Foundation (University of Virginia)
• Original Assignee: University of Virginia Patent Foundation (University of Virginia)
• Inventors: Vereshchetin, Pavel, McElwee-Malloy, Molly
• Primary Examiner(s): Kosson, Rosanne
• Application Number:
  US15/192,468
• Publication Number:
  US 20160374604A1
• Time in Patent Office: 907 Days
• 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 5/14546 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 5/150358 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 5/150419 comprising means for capillary action
• CPC Class Codes: A61B 5/150572 Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
• CPC Class Codes: A61B 5/150664 Pivotable protective sleeves, i.e. sleeves connected to, or integrated in, the piercing or driving device, and which are pivoted for covering or uncovering the piercing element
• CPC Class Codes: A61B 5/150717 manually removed
• CPC Class Codes: A61B 5/15105 Purely manual piercing, i.e. the user pierces the skin without the assistance of any driving means or driving devices
• CPC Class Codes: G01N 27/3272 Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels optical biosensors G01N33/52
• CPC Class Codes: G01N 27/3273 Devices therefor, e.g. test element readers, circuitry details not specific to biochemical electrodes G01N33/4875
• CPC Class Codes: G01N 33/4875 Details of handling test elements, e.g. dispensing or storage, not specific to a particular test method test-elements per se B01L, automatic analysers G01N35/00, in-vivo analysis on the human body for medical diagnosis A61B

Abstract

An electrochemical biosensor test strip device and compatible meter or processor for determining the amount of an analyte in a liquid sample received from a subject. The device may include: a substrate having a liquid sampling end and an electrical contact end; a circuit disposed in communication with the substrate; a reaction area formed at the liquid sampling end of the substrate; and a lancet having a pointed end and an opposite end, whereby the opposite end of the lancet is disposed in communication with the substrate and located at the reaction area. The device may also include an interface area that may be separate or integrated as part the reaction area (or the reaction area may be integrated with interaction area).

Claims

1. An electrochemical biosensor test strip device for determining the amount of an analyte in a liquid sample received from a subject, wherein said device comprises:

a) a substrate having a liquid sampling end and an electrical contact end;

b) a circuit disposed in communication with said substrate;

c) a reaction area formed at said liquid sampling end of said substrate;

d) an interface area located at the liquid sampling end of said substrate;

e) a lancet having a pointed end and an opposite end, whereby said opposite end of said lancet is disposed on said substrate and located at said reaction area; and

wherein said electrical contact end of said substrate and said liquid sampling end of said substrate are configured to be able to fold over or pivot relative to each other such that said electrical end of said substrate folds over said liquid sampling end of said substrate so as to cover said lancet.

2. The device of claim 1, wherein said lancet is stationary relative to said substrate.

3. The device of claim 1, wherein said determining the amount of the analyte includes one or more of the following:

detecting the analyte,

measuring the analyte,

analyzing the analyte, or

obtaining the concentration of the analyte.

4. The device of claim 1, wherein said interface area is configured to be deformable from a rest position to a deformed position upon receiving force exerted by the subject.

5. The device of claim 4, wherein said interface area is configured to have a vertical height in the rest position that extends above the pointed end of said lancet.

6. The device of claim 5, wherein said interface area is configured to have a vertical height in the deformed position that extends below the pointed end of said lancet.

7. The device of claim 1, wherein said interface area comprises a plurality of blunt contact points disposed on its surface that provides sensory signal distraction to the subject during physical contact by the subject.

8. The device of claim 1, wherein said interface area is an absorptive material or structure.

9. The device of claim 1, wherein said interface area is a porous material or structure.

10. The device of claim 1, wherein said interface area is configured to provide a capillary force to carry the liquid sample from the subject to said reaction area.

11. The device of claim 1, wherein said device includes a pivot area whereby said electrical contact end of said substrate pivots, relative to said liquid sampling end of said substrate, at said pivot area from said at least one open position to said substrate fold over position.

12. The device of claim 1, further comprising a fastening material or fastening device disposed on said substrate for securing the electrical contact end of said substrate to said liquid sampling end of said substrate in said substrate fold over position.

13. The device of claim 1, wherein said reaction area comprises one or more enzymes selected to facilitate a reaction with the analyte.

14. The device of claim 13, wherein said analyte comprises glucose.

15. The device of claim 14, wherein the one or more enzymes comprise glucose oxidase or glucose dhydrogenase or both glucose oxidase and glucose dhydrogenase.

16. The device of claim 13, wherein said analyte comprises uric acid.

17. The device of claim 16, wherein the one or more enzymes comprise uricase.

18. The device of claim 13, wherein said analyte comprises cholesterol.

19. The device of claim 18, wherein the one or more enzymes comprise cholesterol oxidase or cholesterol esterase or both cholesterol oxidase and cholesterol esterase.

20. The device of claim 1, wherein said circuit has a meter engagement end configured to engage and communicate with an analyte meter.

21. The device of claim 1, wherein said circuit comprises a reaction area engagement end configured to receive electrical signals provided by said reaction area.

22. The device of claim 1, wherein said reaction area comprises one or more enzymes selected to facilitate a reaction with the analyte to provide electrical signals.

23. The device of claim 22, wherein said circuit comprises a reaction area engagement end configured to receive the electrical signals.

24. The device of claim 1, further comprising a channel disposed in said electrical contact end of said substrate configured to accommodate said lancet in said substrate fold over position.

29. The device of claim 1, wherein said lancet is movable relative to said substrate, whereby said lancet can pivot or change between an upright position and a flat position relative to said substrate.

30. The device of claim 1, wherein said lancet is attachable to and/or removable from said substrate.

31. The device of claim 1, wherein said electrical contact end of said substrate and said liquid sampling end of said substrate are configured to be separable relative to each other.

35. A kit comprising the device of claim 20 or claim 34, wherein the kit further comprises said analyte meter.

25. An electrochemical biosensor test strip device for determining the amount of an analyte in a liquid sample received from a subject, wherein said device comprises:

a) a substrate having a liquid sampling end and an electrical contact end;

b) a circuit disposed in communication with said substrate;

c) a reaction area formed at said liquid sampling end of said substrate;

d) an interface area located at the liquid sampling end of said substrate;

e) a lancet having a pointed end and an opposite end, whereby said opposite end of said lancet is disposed on said substrate and located at said reaction area;

wherein said electrical contact end of said substrate and said liquid sampling end of said substrate are configured to be separable relative to each other;

wherein said electrical contact end can be in at least one open position and wherein said electrical contact position can be in at least one reverse position, and further wherein;

in said at least one open position said electrical contact end is in an one open position relative to said liquid sampling end of said substrate; and

in said at least one reversed position said electrical contact end is placed on top of said liquid sampling end.

33. The device of claim 25, further comprising a channel disposed in said electrical contact end of said substrate configured to accommodate said lancet when said electrical contact is placed on top of said liquid sampling end.

34. The device of claim 25, wherein said circuit has a meter engagement end configured to engage and communicate with an analyte meter.

26. A system for determining the amount of an analyte in a liquid sample received from a subject, wherein said system comprises:

I) an electrochemical biosensor test strip device, said test strip device comprising;

a) a substrate having a liquid sampling end and an electrical contact end;

b) a circuit disposed in communication with said substrate, wherein said circuit has a meter engagement end configured to engage and communicate with an analyte meter;

c) a reaction area formed at said liquid sampling end of said substrate;

d) an interface area located at the liquid sampling end of said substrate;

e) a lancet having a pointed end and an opposite end, whereby said opposite end of said lancet is disposed on said substrate and located at said reaction area;

wherein said electrical contact end of said substrate and said liquid sampling end of said substrate are configured to be able to told over or pivot relative to each other such that said electrical end of said substrate folds over said liquid sampling end of said substrate so as to cover said lancet; and

II) an analyte meter configured to receive data from said electrochemical biosensor test strip device.

27. The system of claim 26, wherein said lancet is stationary relative to said substrate.

28. The system of claim 26, wherein said determining the amount of the analyte includes one or more of the following:

detecting the analyte,

measuring the analyte,

analyzing the analyte, or

obtaining the concentration of the analyte.

32. The system of claim 26, further comprising a channel disposed in said electrical contact end of said substrate configured to accommodate said lancet in said substrate fold over position.