Analyte Test Device

• US 20090018411A1
• Filed: 10/08/2007
• Published: 01/15/2009
• Est. Priority Date: 06/15/2004
• Status: Abandoned Application

• Current Assignee: Abbott Laboratories Incorporated
• Original Assignee: Abbott Laboratories Incorporated
• Inventors: Nicolaisen, Andrea, Dehart, Damon H., Mace, Chad Harold
• Application Number:
  US11/868,762
• Publication Number:
  US 20090018411A1
• Time in Patent Office: Days
• US Class Current: 600/309
• 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 apparatus for measuring an analyte level within a sample of body fluid, comprising:

(a) an integrated analyte test strip including a lancet coupled with a test sensor; and

(b) a housing having an opening defined therein and a sealed recess within which the test strip is initially sealed within the housing to shield the test strip from contamination prior to use, and

(c) wherein the opening is disposed such that the lancet will pierce a lancing site of a user that is disposed in contact with said housing and over said opening by unsealing the test strip and exposing the lancet through the opening defined in the housing; and

(d) wherein body fluid is automatically applied to the test sensor for measuring an analyte level while the lancing site of the user remains approximately at the same location as during said piercing in contact with the housing and over said opening.

2. The apparatus of claim 1, said integrated analyte test strip comprising:

(a) a base, said base including a top surface, a bottom surface, a front end and a rear end, and

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

(c) wherein said lancet is mounted on said base, and

(d) wherein said test strip is coupled with said base, and includes a first end, a second end and a plurality of electrodes.

3. The apparatus of claim 1, comprising a unitary, single-use, disposable test cartridge.

4. The apparatus of claim 3, comprising a substantially flat, low profile design.

5. The apparatus of claim 1, wherein a skin receiving surface is formed into the front end of said base.

6. The apparatus of 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 apparatus of claim 1, wherein said lancet comprises a sharpened needle.

8. The apparatus of claim 1, wherein said analyte test strip is adapted to be retained against said base.

9. The apparatus of claim 1, wherein a portion of said analyte test strip is externally visible.

10. The apparatus of claim 1, wherein said housing defines a substantially enclosed interior cavity sized and shaped to receive said base, said lancet and said test strip.

11. The apparatus of claim 10, wherein an opening is formed into the front end of said housing, such that when the interior cavity is unsealed, the opening is in communication with the interior cavity, such that the integrated analyte test strip is exposed.

12. The apparatus of claim 1, further comprising a cap mounted on said lancet.

18. The apparatus of claim 1, wherein said housing defines a substantially enclosed interior cavity sized and shaped to receive said integrated analyte test strip.

19. The method of claim 18, wherein an opening is formed into the front end of said housing, such that when the interior cavity is unsealed, the opening is in communication with the interior cavity such that the integrated analyte test strip is exposed.

13. A method of providing a sample of body fluid to a test strip for measuring an analyte level within the fluid, comprising:

(a) loading within a housing an integrated analyte test strip including a lancet coupled with a test sensor, the housing having an opening defined therein, and wherein the test strip is initially sealed within the housing to shield the test strip from contamination prior to use;

(b) piercing a lancing site of a user by unsealing the test strip and exposing the lancet through the opening defined in the housing when the lancing site is disposed in contact with said housing and over said opening; and

(c) automatically applying body fluid to the test sensor for measuring an analyte level while the lancing site of the user remains approximately at the same location as during said piercing in contact with the housing and over said opening.

14. The method of claim 13, further comprising utilizing said integrated analyte test strip as a unitary, single-use, disposable test cartridge.

15. The method of claim 13, further comprising contacting said lancing site with a portion of said test sensor that is in the form of an arcuate notch which extends inward.

16. The method of claim 13, wherein said lancet comprises a sharpened needle.

17. The method of claim 13, wherein a portion of said analyte test strip is externally visible during said applying.

20. The method of claim 13, further comprising removing a cap initially mounted on said lancet.