Analyte test device

• US 8,971,980 B2
• Filed: 07/31/2007
• Issued: 03/03/2015
• Est. Priority Date: 06/15/2004
• 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, Nicolaisen, Andrea, Dehart, Damon H.
• Primary Examiner(s): Mallari, Patricia
• Assistant Examiner(s): WESTON, TIFFANY C
• Application Number:
  US11/831,649
• Publication Number:
  US 20080033318A1
• Time in Patent Office: 2,772 Days
• Field of Search: 600/347, 600/365, 600/345
• US Class Current: 600/345
• 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 flat lancet carrier comprising a flat spring and a lancet support surface, said lancet carrier including a top surface, a bottom surface, a front end and a rear end;

a lancet comprising a flat member having a needle projecting therefrom, the lancet extending along said lancet support surface and said flat spring, said lancet secured to a first end of said spring;

an analyte test strip coupled to the lancet carrier and lancet, the test strip including a plurality of electrodes and assay chemistry; and

a housing comprising a base and a cover, the housing including an interior cavity being sized and shaped to receive said lancet carrier, said lancet, and said test strip, wherein said housing comprises a skin receiving surface at a proximal end of said housing and an opening in communication with said interior cavity formed into said proximal end of said housing, wherein electrical contacts of the analyte test strip are accessible to a compatible analyte test meter at a distal end of said housing, and

wherein said skin receiving surface is in the form of a notch which extends inward from said proximal end toward a distal end of said housing, wherein the width of the notch is less than the width of the analyte test strip.

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

3. The device of claim 1, wherein said spring is integrally formed into said lancet carrier.

4. The device of claim 1, wherein a recess is formed into the top surface of said lancet carrier, said recess being sized and shaped to receive said lancet.

5. The device of claim 1, wherein said lancet is positioned between said test strip and said lancet carrier.

6. The device of claim 1, wherein said lancet carrier is positioned between said test strip and said lancet.

7. The device of claim 1, wherein said device is constructed as a unitary, single use, disposable tester.

8. The device of claim 1, wherein said notch is an arcuate notch.

9. The device of claim 1, wherein said notch is on said base.

10. The device of claim 9, wherein said notch is an arcuate notch.

11. The device of claim 1, wherein said lancet carrier is fixedly coupled to said base at a distal end of said housing.