Analyte test device

• US 20050277850A1
• Filed: 06/15/2004
• Published: 12/15/2005
• Est. Priority Date: 06/15/2004
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories)
• Original Assignee: Abbott Laboratories
• Inventors: Nicolaisen, Andrea, Mace, Chad Harold, Dehart, Damon H.
• Granted Patent: US 7,299,081 B2
• Time in Patent Office: Days
• US Class Current: 600/584
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157
• 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 5/150358 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 5/15107 Piercing being assisted by a triggering mechanism
• CPC Class Codes: A61B 5/1513 comprising linear sliding guides comprising tooth-shaped elements A61B5/15132
• CPC Class Codes: A61B 5/15151 Each piercing element being stocked in a separate isolated compartment
• CPC Class Codes: A61B 5/15161 Characterized by propelling the piercing element in a radial direction relative to the disc
• CPC Class Codes: A61B 5/15176 Stocking means comprising cap, cover, sheath or protection for aseptic stocking
• CPC Class Codes: A61B 5/1519 comprising driving means, e.g. a spring, for propelling the piercing unit
• CPC Class Codes: A61B 5/15194 fully automatically retracted, i.e. the retraction does not require a deliberate action by the user, e.g. by terminating the contact with the patient's skin

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 and, in turn, calculate the concentration of a particular analyte in the expressed blood sample. In one embodiment, the device includes a base and a cover which are affixed together to create a test cartridge which has a substantially flat and low profile design. A lancet carrier is disposed between the base and the cover and includes a anchor fixedly mounted on the base and a lancet support member which is slidably mounted on the base, the anchor and the lancet support member being connected by a spring. A lancet is removably mounted on the lancet support member is disposed directly beneath an analyte test strip which secured to the underside of the cover. In another embodiment, the device includes a cylindrical housing with an open top end and an open bottom end. A spring biased lancet is slidably mounted within the cylindrical housing. An analyte test strip is fixedly mounted within the cylindrical housing and is disposed at an acute angle relative to the lancet.

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 front end and a rear end,

(b) a cover removably affixed to said base, said cover including a top surface, a bottom surface, a front end and a rear end,

(c) a lancet carrier disposed between said base and said cover, said lancet carrier comprising a spring, the spring having a first end and a second end, the first end of the spring being fixedly coupled to said base, the second end of the spring capable of displacement relative to the first end,

(d) a lancet removably mounted on said lancet carrier, and

(e) an analyte test strip disposed between said base and said cover, said analyte test strip having a first end, a second end and a plurality of electrodes.

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

3. The analyte test device as claimed in claim 2 wherein said device has a substantially flat, low profile design.

4. The analyte test device as claimed in claim 3 wherein the bottom surface of said base and the top surface of said cover are flat.

5. The analyte test device as claimed in claim 1 wherein a skin receiving surface is formed into the front end of said base.

6. The analyte test device as claimed in claim 5 wherein the skin receiving surface is in the form of an arcuate notch which extends inward from the front end of the base.

7. The analyte test device as claimed in claim 1 wherein a anchor is formed onto the first end of the spring.

8. The analyte test device as claimed in claim 7 wherein the anchor is fixedly secured to said base.

9. The analyte test device as claimed in claim 8 wherein a lancet support member is formed onto the second end of the spring, said lancet support member being slidably mounted on the base and capable of linear displacement relative to said anchor.

10. The analyte test device as claimed in claim 9 wherein said lancet comprises:

(a) a tab adapted to be releasably retained on the lancet support member, and

(b) a sharpened needle formed onto said tab.

11. The analyte test device as claimed in claim 1 wherein said analyte test strip is adapted to be retained against said cover.

12. The analyte test device as claimed in claim 11 wherein said cover is shaped to define an opening along its front end through which a portion of the first end of said analyte test strip is externally visible.

13. The analyte test device as claimed in claim 12 wherein said cover is shaped to define a window through which the plurality of electrodes are externally accessible.

14. 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 front end and a rear end,

(b) a lancet removably mounted on said base,

(c) an analyte test strip mounted on said base over said lancet, said analyte test strip comprising a first end, a second end and a plurality of electrodes, and

(d) a housing, said housing including a top surface, a bottom surface, a front end, a rear end and a pair of sidewalls which together define a substantially enclosed interior cavity, the interior cavity being sized and shaped to receive said base, said lancet and said analyte test strip.

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

16. The analyte test device as claimed in claim 15 wherein said device has a substantially flat, low profile design.

17. The analyte test device as claimed in claim 16 wherein the top and bottom surfaces of said housing are flat.

18. The analyte test device as claimed in claim 14 wherein an opening is formed into the front end of said housing, the opening being in communication with the interior cavity.

19. The analyte test device as claimed in claim 18 wherein a skin receiving surface is formed into the front end of said base immediately surrounding the opening.

20. The analyte test device as claimed in claim 14 wherein a shallow recess is formed into the top surface of said base, the shallow recess being sized and shaped to receive said lancet.

21. The analyte test device as claimed in claim 14 wherein a spring is integrally formed into said base, the spring including a first end and a second end.

22. The analyte test device as claimed in claim 21 wherein the first end of the spring is fixed in place and wherein the second end of the spring is capable of displacement relative to the first end of the spring.

23. The analyte test device as claimed in claim 22 wherein said lancet is mounted on the second end of the spring.

24. The analyte test device as claimed in claim 23 wherein said lancet is substantially flat and includes a sharpened needle.

25. The analyte test device as claimed in claim 24 wherein a window is formed into the top surface of said housing through which the plurality of electrodes are externally accessible.

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

(a) a housing shaped to define an interior cavity,

(b) a lancet slidably mounted within the interior cavity of said housing, said lancet comprising a sharpened tip, the sharpened tip being adapted to selectively penetrate outside of the interior cavity of said housing, and

(c) an analyte test strip disposed within the interior cavity of said housing at an acute angle relative to said lancet, said analyte test strip comprising a first end, a second end and a plurality of electrodes.

27. The analyte test device as claimed in claim 26 wherein said device is constructed as a unitary, single-use, disposable test cartridge.

28. The analyte test device as claimed in claim 26 wherein said housing includes a generally cylindrical sidewall which defines the interior cavity, the sidewall comprising an inner surface, an outer surface, an open bottom end and an open top end.

29. The analyte test device as claimed in claim 28 wherein said analyte test strip is fixedly mounted onto the inner surface of the sidewall, the first end of said analyte test strip being spaced in from the open bottom end of said housing.

30. The analyte test device as claimed in claim 29 wherein a needle support is integrally formed onto the inner surface of said housing, the needle support being shaped to define a longitudinal bore which is sized and shaped to receive at least a portion of said lancet.

31. The analyte test device as claimed in claim 30 further comprising a spring for resiliently urging said the tip of said lancet away from the open bottom end of said housing, said spring including a first end and a second end.

32. The analyte test device as claimed in claim 31 further comprising a cap, said cap being fixedly mounted on said lancet.

33. The analyte test device as claimed in claim 32 wherein said spring is mounted axially over said lancet with the first end of said spring disposed against the needle support in said housing and the second end of said spring disposed against the cap.