Analyte Test Device

• US 20080033318A1
• Filed: 07/31/2007
• Published: 02/07/2008
• Est. Priority Date: 06/15/2004
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Laboratories Incorporated
• Inventors: Mace, Chad, Dehart, Damon, Nicolaisen, Andrea
• Granted Patent: US 8,971,980 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 5/150358 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 affixed to said base, said cover including a top surface, a bottom surface, a front end and a rear end;

(c) a lancet carrier;

(d) a lancet mounted on said lancet carrier; and

(e) an analyte testing region including a plurality of electrodes and assay chemistry disposed between said base and said cover; and

(f) wherein said device is constructed as a unitary, single-use, disposable tester; and

(g) wherein said device has a low profile design.

2. The device of claim 1, wherein a skin receiving surface is formed into the front end of said base in the form of an arcuate notch which extends inward from the front end of the base.

3. The device of claim 1, wherein said device has a substantially flat design.

4. The device of claim 3, wherein a skin receiving surface is formed into the front end of said base in the form of an arcuate notch which extends inward from the front end of the base.

5. The device of claim 3, wherein the bottom surface of said base and the top surface of said cover are flat.

6. The device of claim 5, wherein a skin receiving surface is formed into the front end of said base in the form of an arcuate notch which extends inward from the front end of the base.

7. The device of claim 1, wherein the bottom surface of said base and the top surface of said cover are flat.

8. The device of claim 7, wherein a skin receiving surface is formed into the front end of said base in the form of an arcuate notch which extends inward from the front end of the base.

9. The device of claim 1, wherein said lancet comprises a sharpened needle.

10. The device of claim 1, further comprising a cap mounted on said lancet.

11. 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 affixed to said base, said cover including a top surface, a bottom surface, a front end and a rear end;

(c) a lancet carrier;

(d) a lancet mounted on said lancet carrier; and

(e) an analyte testing region including a plurality of electrodes and assay chemistry disposed between said base and said cover; and

(f) wherein said device is constructed as a unitary, single-use, disposable tester; and

(g) wherein the bottom surface of said base and the top surface of said cover are flat.

12. The device of claim 11, wherein a skin receiving surface is formed into the front end of said base in the form of an arcuate notch which extends inward from the front end of the base.

13. The device of claim 11, wherein said device has a substantially flat design.

14. The device of claim 13, wherein a skin receiving surface is formed into the front end of said base in the form of an arcuate notch which extends inward from the front end of the base.

15. The device of claim 11, wherein said lancet comprises a sharpened needle.

16. The device of claim 11, further comprising a cap mounted on said lancet.

17. 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 affixed to said base, said cover including a top surface, a bottom surface, a front end and a rear end;

(c) a lancet carrier;

(d) a lancet mounted on said lancet carrier; and

(e) an analyte testing region including a plurality of electrodes and assay chemistry disposed between said base and said cover; and

(f) wherein said device is constructed as a unitary, single-use, disposable tester; and

(i) wherein a skin receiving surface is formed into the front end of said base in the form of an arcuate notch which extends inward from the front end of the base.

18. The device of claim 17, wherein said device has a substantially flat design.

19. The device of claim 17, wherein said lancet comprises a sharpened needle.

20. The device of claim 17, further comprising a cap mounted on said lancet.