Analyte test device

• US 9,101,302 B2
• Filed: 05/03/2004
• Issued: 08/11/2015
• 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: Mace, Chad Harold, Yang, Paul Sen, Shahrokni, Farzad
• Primary Examiner(s): Mallari, Patricia
• Assistant Examiner(s): CATINA, MICHAEL ANTHONY
• Application Number:
  US10/837,886
• Publication Number:
  US 20050245844A1
• Time in Patent Office: 4,117 Days
• Field of Search: 600/345, 600/347, 600/365
• US Class Current: 1/1
• 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, comprising:

a housing shaped to define an aperture for receiving a body fluid sample through the skin of a patient disposed at the aperture, the housing defining a cavity spaced apart and isolated from the aperture, the cavity being externally accessible through an opening;

an analyte test sensor coupled within said housing such that said test sensor is exposed to both of said aperture and said cavity, said test sensor comprising a reaction area defined between a plurality of electrodes, said test sensor configured such that a vacuum path is formed between said test sensor and a surface within said housing such that said body fluid sample is drawn from said aperture to said reaction area and prevented from entering said cavity during a process for analyte testing of said body fluid sample;

a mechanically-fired lancet coupled within said housing and disposed for projecting through said aperture for puncturing said skin of said patient,

wherein said test sensor is adapted to collect said body fluid sample at said reaction area from said patient through said aperture and said vacuum path after said puncturing of said skin of said patient without moving said skin of said patient relative to its position during puncturing, and

wherein said housing comprises a skin receiving surface around said aperture, and wherein the skin receiving surface has an inward contour which is substantially rounded.

2. The analyte test device as claimed in claim 1, further comprising a gasket, wherein said gasket comprises a ring-shaped pad constructed of a sticky material which is adapted to be pressed against the patient'"'"'s skin and to grab the skin when so pressed.

3. The analyte test device as claimed in claim 2, further comprising an outer protective layer over said ring-shaped pad which can be peeled off, thereby exposing pad and aperture.

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

28. The analyte test device as claimed in claim 1 wherein the interior cavity is externally accessible through said opening.

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

30. The analyte test device as claimed in claim 29 wherein the skin receiving surface at least partially defines the aperture in said housing.

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

32. The analyte test device as claimed in claim 31 wherein the reaction area of said test sensor is disposed to project into said vacuum path.

33. The analyte test device as claimed in claim 31 wherein the reaction area of said test sensor is disposed to project into said aperture.

34. The analyte test device as claimed in claim 31 wherein a cover layer of said test sensor is affixed to a base layer of said test sensor using an adhesive.

35. The analyte test device as claimed in claim 31 wherein at least a portion of said electrodes are externally accessible.

36. The analyte test device as claimed in claim 1 wherein a cover of the device is constructed of a transparent material.

37. The analyte test device as claimed in claim 1 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.

38. The analyte test device as claimed in claim 1 wherein said lancet is aligned to project through the aperture in said base upon deformation of a flexible dome-shaped member.

39. The analyte test sensor of claim 1, wherein said lancet is adapted to selectively penetrate through the aperture in the housing.

40. The analyte test device as claimed in claim 31 wherein said device is constructed as a unitary, single-use, disposable cartridge.

41. The analyte test device as claimed in claim 1 further comprising a pad coupled to a bottom surface of the said test sensor.

42. The analyte test device as claimed in claim 41 further comprising a protective layer coupled to the bottom surface of said test sensor over said pad.

43. The analyte test device as claimed in claim 42 wherein said protective layer is constructed as a thin layer of sealing tape.

44. The analyte test device as claimed in claim 1 further comprising a flexible member coupled to the lancet.

45. The analyte test device as claimed in claim 44 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.

46. The analyte test device as claimed in claim 41 wherein said lancet is aligned to project through said aperture defined in the bottom surface of the test sensor.

47. The analyte test device as claimed in claim 1, wherein the cavity is U-shaped in longitudinal cross-section.

4. An analyte test device, comprising:

a housing shaped to define an aperture for receiving a body fluid sample through the skin of a patient disposed at the aperture, the housing defining a cavity spaced apart and isolated from the aperture, the cavity being externally accessible through an opening;

an analyte test sensor coupled within said housing such that said test sensor is exposed to both of said aperture and said cavity, said test sensor comprising a reaction area defined between a plurality of electrodes, said test sensor configured such that a vacuum path is formed between said test sensor and a surface within said housing such that said body fluid sample is drawn from said aperture to said reaction area and prevented from entering said cavity during a process for analyte testing of said body fluid sample;

a mechanically-fired lancet coupled within said housing and disposed for projecting through said aperture for puncturing said skin of said patient,

wherein said test sensor is adapted to collect said body fluid sample at said reaction area from said patient through said aperture and said vacuum path after said puncturing of said skin of said patient without moving said skin of said patient relative to its position during puncturing,

wherein said housing comprises a skin receiving surface around said aperture, and a gasket coupled to said housing immediately surrounding said skin receiving surface to create an effective seal between the patient'"'"'s skin and the device; and

wherein the skin receiving surface has an inward contour which is substantially rounded.

5. The analyte test device as claimed in claim 4, wherein said device is constructed as a unitary, single-use, disposable cartridge.

6. The analyte test device as claimed in claim 4, wherein the interior cavity is externally accessible through said opening.

7. The analyte test device as claimed in claim 4, wherein a bottom surface of said housing is shaped to include said skin receiving surface.

8. The analyte test device as claimed in claim 7, wherein the skin receiving surface at least partially defines the aperture in said housing.

9. The analyte test device as claimed in claim 4, wherein said analyte test sensor comprises an electrochemical analyte test sensor which comprises said reaction area.

10. The analyte test device as claimed in claim 9, wherein the reaction area of said test sensor is disposed to project into said vacuum path.

11. The analyte test device as claimed in claim 9, wherein the reaction area of said test sensor is disposed to project into said aperture.

12. The analyte test device as claimed in claim 9, wherein a cover layer of said test sensor is affixed to a base layer of said test sensor using an adhesive.

13. The analyte test device as claimed in claim 9, wherein at least a portion of said electrodes are externally accessible.

14. The analyte test device as claimed in claim 9 wherein said device is constructed as a unitary, single-use, disposable cartridge.

15. The analyte test device as claimed in claim 4, wherein a cover of the device is constructed of a transparent material.

16. The analyte test device as claimed in claim 4, 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.

17. The analyte test device as claimed in claim 4, wherein said lancet is aligned to project through the aperture in said base upon deformation of a flexible dome-shaped member.

18. The analyte test sensor as claimed in claim 4, wherein said lancet is adapted to selectively penetrate through the aperture in the housing.

19. The analyte test device as claimed in claim 4, further comprising a pad coupled to a bottom surface of the said test sensor.

20. The analyte test device as claimed in claim 19 further comprising a protective layer coupled to the bottom surface of said test sensor over said pad.

21. The analyte test device as claimed in claim 20 wherein said protective layer is constructed as a thin layer of sealing tape.

22. The analyte test device as claimed in claim 19 wherein said lancet is aligned to project through said aperture defined in the bottom surface of the test sensor.

23. The analyte test device as claimed in claim 4 further comprising a flexible member coupled to the lancet.

24. The analyte test device as claimed in claim 23 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.

25. The analyte test device as claimed in claim 4, wherein said gasket comprises a ring-shaped pad constructed of a sticky material which is adapted to be pressed against the patient'"'"'s skin and to grab the skin when so pressed.

26. The analyte test device as claimed in claim 25, further comprising an outer protective layer over said ring-shaped pad which can be peeled off, thereby exposing pad and aperture.