Analyte test device

• US 20050245844A1
• Filed: 05/03/2004
• Published: 11/03/2005
• Est. Priority Date: 05/03/2004
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Shahrokni, Farzad, Mace, Chad Harold, Yang, Paul Sen
• Granted Patent: US 9,101,302 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 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150099 by negative pressure, other than vacuum extraction into a syringe by pulling on the piston rod or into pre-evacuated tubes
• CPC Class Codes: A61B 5/150229 Pumps for assisting the blood sampling
• CPC Class Codes: A61B 5/150305 Packages specially adapted for piercing devices or blood sampling devices kits for diabetes A61M5/003; packaging in general B65D
• 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 5/150534 Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
• CPC Class Codes: A61B 5/150969 Low-profile devices which resemble patches or plasters, e.g. also allowing collection of blood samples for testing
• CPC Class Codes: A61B 5/15144 comprising driving means, e.g. a spring, for retracting the piercing unit into the housing
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood

Abstract

An analyte test device is constructed as an integrated, single-use, disposable cartridge which can be releasably installed into a compatible analyte test monitor. In use, the device can be used in conjunction with the monitor to lance the skin of a patient to create a blood sample, express the blood sample from the wound site using vacuum forces and calculate the concentration of a particular analyte in the expressed blood sample. In one embodiment, the device includes a base which includes a top surface and a bottom surface. The base is also shaped to define an aperture which extends transversely through its top and bottom surfaces. An electrochemical test sensor is affixed to the base in such a manner so that a vacuum path is at least partially defined between the base and the test sensor, the vacuum path being in fluid communication with the aperture. A cover is affixed to the top surface of the base over the aperture, the cover comprising a flexible dome-shaped member and a lancet coupled to the member, the lancet being orientated such that its longitudinal axis extends at an approximate right angle relative to the longitudinal axis of the test sensor. The bottom surface of the base is shaped to include a skin receiving surface which at least partially defines the aperture in the base, the skin receiving surface having a steep inward contour to distend the skin of the patient when pressed thereagainst.

Claims

1. An analyte test device which is adapted to be removably coupled to a compatible analyte test meter, said analyte test device comprising:

(a) a base, said base including a top surface, a bottom surface, a first end and a second end, said base being shaped to define an aperture which extends transversely through its top and bottom surfaces,

(b) an analyte test sensor coupled to said base, said base and said test sensor together at least partially defining a vacuum path in fluid communication with said aperture, and

(c) a cover coupled to the top surface of said base over the aperture.

2. The analyte test device as claimed in claim 1 wherein said device is constructed as a unitary, single-use, disposable cartridge.

3. The analyte test device as claimed in claim 1 wherein the second end of said base is adapted to matingly engage with said analyte test meter.

4. The analyte test device as claimed in claim 1 wherein the second end of said base is shaped to define an opening, said base being adapted to receive the connector of a vacuum tube through the opening.

5. The analyte test device as claimed in claim 4 wherein said base is shaped to define an interior cavity in fluid communication with the vacuum path and the opening.

6. The analyte test device as claimed in claim 5 wherein the opening is in fluid communication with the aperture via the interior cavity.

7. The analyte test device as claimed in claim 6 wherein the interior cavity is externally accessible through said opening.

8. The analyte test device as claimed in claim 1 wherein the bottom surface of said base is shaped to include a skin receiving surface.

9. The analyte test device as claimed in claim 8 wherein the skin receiving surface at least partially defines the aperture in said base.

10. The analyte test device as claimed in claim 9 wherein the skin receiving surface has a steep inward contour.

11. The analyte test device as claimed in claim 1 wherein said analyte test sensor is an electrochemical analyte test sensor which comprises a reaction area.

12. The analyte test device as claimed in claim 11 wherein the reaction area of said test sensor is disposed to project into said vacuum path.

13. The analyte test device as claimed in claim 11 wherein the reaction area of said test sensor is disposed to project into said aperture.

14. The analyte test device as claimed in claim 11 wherein said test sensor is affixed to said base using an adhesive.

15. The analyte test device as claimed in claim 11 wherein said test sensor comprises a plurality of electrodes, at least a portion of said electrodes being externally accessible.

16. The analyte test device as claimed in claim 1 wherein said cover is affixed to said base over said test strip.

17. The analyte test device as claimed in claim 16 wherein said cover is constructed of a transparent material.

18. The analyte test device as claimed in claim 16 wherein said cover includes:

(a) a flexible dome-shaped member, and

(b) a lancet coupled to said member.

19. The analyte test device as claimed in claim 18 wherein said lancet is orientated such that its longitudinal axis extends at an approximate right angle relative to the longitudinal axis of said analyte test sensor.

20. The analyte test device as claimed in claim 18 wherein said lancet is aligned to project through the aperture in said base upon deformation of said flexible dome-shaped member.

21. An analyte test device which is adapted to be removably coupled to a compatible analyte test meter, said analyte test device comprising:

(a) an analyte test sensor, said analyte test sensor comprising a substrate and a reaction area on said substrate, said substrate comprising a top surface, a bottom surface, a first end and a second end, said substrate being shaped to define an aperture which extends transversely through its top and bottom surfaces, and

(b) a flexible member coupled to the top surface of the substrate over the aperture, said flexible member comprising a lancet adapted to selectively penetrate through the aperture in the substrate.

22. The analyte test device as claimed in claim 21 wherein said device is constructed as a unitary, single-use, disposable cartridge.

23. The analyte test device as claimed in claim 21 further comprising a pad coupled to the bottom surface of said substrate around the aperture.

24. The analyte test device as claimed in claim 23 wherein said pad is constructed of a sticky material.

25. The analyte test device as claimed in claim 24 wherein said pad has an annular shape.

26. The analyte test device as claimed in claim 23 further comprising a protective layer coupled to the bottom surface of said substrate over said pad.

27. The analyte test device as claimed in claim 26 wherein said protective layer is constructed as a thin layer of sealing tape.

28. The analyte test device as claimed in claim 21 wherein the reaction area is located on the top surface of the substrate.

29. The analyte test device as claimed in claim 28 wherein said flexible member is affixed to the top surface of said substrate over at least a portion of the reaction area.

30. The analyte test device as claimed in claim 23 wherein the reaction area is located on the bottom surface of the substrate.

31. The analyte test device as claimed in claim 30 wherein said pad is affixed to the bottom surface of said substrate around at least a portion of the reaction area.

32. The analyte test device as claimed in claim 21 wherein said flexible member includes a dome.

33. The analyte test device as claimed in claim 32 wherein said lancet is coupled to said dome.

34. The analyte test device as claimed in claim 33 wherein said lancet is orientated such that its longitudinal axis extends at an approximate right angle relative to the longitudinal axis of said analyte test sensor.

35. The analyte test device as claimed in claim 33 wherein said lancet is aligned to project through the aperture in the substrate upon deformation of said dome.