ANALYTE TEST DEVICE

• US 20080188732A1
• Filed: 02/21/2008
• Published: 08/07/2008
• Est. Priority Date: 06/15/2004
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Laboratories Incorporated
• Inventors: Nicolaisen, Andrea, Mace, Chad Harold, Dehart, Damon H.
• Granted Patent: US 8,509,870 B2
• Time in Patent Office: Days
• US Class Current: 600/347
• 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. A unitary, disposable test cartridge capable of being removably coupled to a compatible analyte meter, said unitary, disposable cartridge comprising:

(a) a base, the base including a top surface, a bottom surface, a front end, and a read end,

(b) a cover coupled to the base, whereby a substantially enclosed volume is provided,

(c) a lancet carrier defining the substantially enclosed volume,

(d) a lancet removably mounted on the lancet carrier within the substantially enclosed volume, and

(e) an analyte test strip disposed between the base and the cover in the substantially enclosed volume, the analyte test strip having a first end, a second end and a plurality of electrodes, wherein the base includes a pair of elongated sidewalls between which the plurality of electrodes are externally accessible, and

(f) a skin receiving surface formed into the front end of said base in the form of an arcuate notch that extends inward from the front end of the base.

2. The unitary, disposable test cartridge as claimed in claim 1, further comprising a support member adapted for stable, releasable retention of the cartridge.

3. The unitary, disposable test cartridge as claimed in claim 1 wherein the cartridge has a substantially flat, low profile design.

4. The unitary, disposable test cartridge as claimed in claim 3 wherein the top and bottom surfaces of the housing are flat.

5. The unitary, disposable test cartridge as claimed in claim 4 wherein a recess is formed within the base, the shallow recess being sized and shaped to retain the lancet.

6. The unitary, disposable test cartridge as claimed in claim 1, wherein the lancet includes a sharpened needle.

7. A unitary, disposable test cartridge capable of being removably coupled to a compatible analyte meter, said unitary, disposable cartridge comprising:

(a) a base, the base including a top surface, a bottom surface, a front end, and a read end,

(b) a cover coupled to the base, whereby a substantially enclosed volume is provided,

(c) a lancet carrier defining a further substantially enclosed volume,

(d) a lancet removably mounted on the lancet carrier within the substantially enclosed volumes, and

(e) an analyte test strip having a first end, a second end and a plurality of electrodes, wherein the base includes a pair of elongated sidewalls between which the plurality of electrodes is externally accessible, and

(f) wherein said analyte test strip is adapted to be retained between the pair of elongated sidewalls, which sidewalls each have an L-shaped cross section including an outer section at either side of the analyte test strip and an overhang portion beneath which an outer edge of the analyte test strip is disposed, and

(g) wherein the elongated sidewalls are shaped to define an opening through which a portion of the analyte test strip is externally visible including a lower space and an upper space, wherein the lower space is defined between the outer sections of the elongated sidewalls and is shaped for disposing the test strip therein and thus has dimensions at least including those of the analyte test strip, and wherein the upper space is defined between the overhang portions of the elongated sidewalls and thus has at least a width dimension that is less than a width of the analyte test strip.

8. The unitary, disposable test cartridge as claimed in claim 7 wherein the cartridge has a substantially flat, low profile design.

9. The unitary, disposable test cartridge as claimed in claim 8 wherein the top and bottom surfaces of the housing are flat.

10. The unitary, disposable test cartridge as claimed in claim 9 wherein a recess is formed within the base, the shallow recess being sized and shaped to retain the lancet.

11. The unitary, disposable test cartridge as claimed in claim 7, wherein the lancet includes a sharpened needle.

12. The unitary, disposable test cartridge as claimed in claim 7, further comprising a skin receiving surface formed into the front end of the base.

13. The unitary, disposable test cartridge as claimed in claim 12, wherein the skin receiving surface includes an arcuate notch that extends inward from the front end of the base.

14. The unitary, disposable test cartridge as claimed in claim 7, further comprising a support member adapted for stable, releasable retention of the cartridge.

15. 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 coupled with said housing, said analyte test strip comprising a first end, a second end and a plurality of electrodes, and

(d) a cap mounted on said lancet, and

(e) wherein said housing includes a generally cylindrical sidewall which defines the interior cavity, the sidewall comprising an inner surface and an open end, and

(f) 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 end of said sidewall, and

(g) wherein a needle support is integrally formed by the generally cylindrical sidewall, the needle support being shaped to define a longitudinal bore which is sized and shaped to receive at least a portion of said lancet.

16. The unitary, disposable test cartridge as claimed in claim 15, further comprising a skin receiving surface formed into the front end of said base in the form of an arcuate notch that extends inward from the front end of the base.

17. The unitary, disposable test cartridge as claimed in claim 15, wherein the housing includes a pair of elongated sidewalls between which the plurality of electrodes is externally accessible.

18. The unitary, disposable test cartridge as claimed in claim 17, wherein said analyte test strip is adapted to be retained between the pair of elongated sidewalls, which sidewalls each have an L-shaped cross section including an outer section at either side of the analyte test strip and an overhang portion beneath which an outer edge of the analyte test strip is disposed.

19. The unitary, disposable analyte test strip cartridge as claimed in claim 18, wherein the elongated sidewalls are shaped to define an opening through which a portion of the analyte test strip is externally visible including a lower space and an upper space, wherein the lower space is defined between the outer sections of the elongated sidewalls and is shaped for disposing the test strip therein and thus has dimensions at least including those of the analyte test strip, and wherein the upper space is defined between the overhang portions of the elongated sidewalls and thus has at least a width dimension that is less than a width of the analyte test strip.

20. The unitary, disposable test cartridge as claimed in claim 15, further comprising a support member adapted for stable, releasable retention of the cartridge.