Method and apparatus for measuring analytes

• US 20060200044A1
• Filed: 12/15/2003
• Published: 09/07/2006
• Est. Priority Date: 04/19/2002
• Status: Abandoned Application

• Current Assignee: Pelikan Technologies, Inc.
• Original Assignee: Pelikan Technologies, Inc.
• Inventors: Freeman, Dominique M, Boecker, Dirk
• Application Number:
  US10/540,912
• Publication Number:
  US 20060200044A1
• Time in Patent Office: Days
• US Class Current: 600/583
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150152 by an adequate mechanical impact on the puncturing location
• CPC Class Codes: A61B 5/150167 Adjustable piercing speed of skin piercing element, e.g. blade, needle, lancet or canula, for example with varying spring force or pneumatic drive
• CPC Class Codes: A61B 5/150213 Venting means
• CPC Class Codes: A61B 5/150305 Packages specially adapted for piercing devices or blood sampling devices kits for diabetes A61M5/003; packaging in general B65D
• 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 5/150412 Pointed piercing elements, e.g. needles, lancets for piercing the skin blade-like piercing elements A61B5/150442
• CPC Class Codes: A61B 5/150824 by visual feedback
• CPC Class Codes: A61B 5/15113 Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
• CPC Class Codes: A61B 5/15123 comprising magnets or solenoids
• 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 5/15169 Characterized by a rolled strip
• CPC Class Codes: A61B 5/15171 Characterized by propelling the piercing element perpendicular to the direction of movement of the strip
• CPC Class Codes: A61B 5/15176 Stocking means comprising cap, cover, sheath or protection for aseptic stocking
• CPC Class Codes: A61B 5/15182 Means for keeping track or checking of the total number of piercing elements already used or the number of piercing elements still remaining in the stocking, e.g. by check window, counter, display
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61B 5/259 using conductive adhesive means, e.g. gels
• CPC Class Codes: B82Y 10/00 Nanotechnology for information processing, storage or transmission, e.g. quantum computing or single electron logic
• CPC Class Codes: B82Y 15/00 : Nanotechnology for interacting, sensing or actuating, e.g. quantum dots as markers in protein assays or molecular motors
• CPC Class Codes: B82Y 30/00 : Nanotechnology for materials or surface science, e.g. nanocomposites

Abstract

A device comprises a cartridge (12) and a plurality of analyte detecting members (18) mounted on said cartridge. The cartridge may have a radial disc shape. The analyte detecting members may be a three-electrode system wherein only a working electrode is covered with a glucose oxidase. In one embodiment, the device may also include a fluid spreader (28) positioned over at least a portion of said analyte detecting member to urge fluid toward one of the detecting members. A plurality of analyte detecting members may be used. Each analyte detecting member may be a low volume device.

Claims

1. A device for use with a metering device for measuring analyte levels, said device comprising:

a cartridge;

a plurality of analyte detecting members mounted on said cartridge.

2. The device of claim 1 wherein said cartridge does not include any penetrating members.

3. The device of claim 1 wherein said cartridge has a radial disc shape.

4. The device of claim 1 wherein said cartridge is sized to fit withn said metering device.

5. The device of claim 1 wherein said analyte detecting members wherein only a working electrode is covered with a glucose oxidase.

6. The device of claim 1 wherein said analyte detecting members include working and counter electrodes formed from one of the following:

Ag or Ag/Cl.

7. The device of claim 1 wherein said analyte detecting members have different sensitivity ranges enhancing the overall range of sensitivity of an array of such members when used on a single fluid sample.

8. The device of claim 1 wherein said analyte detecting members can provide their analysis requiring no more than one of the following volumes:

300, 200, 100, 60, 50, 30, 20, 15, 10, and 5 nanoliters.

9. The device of claim 1 wherein said analyte detecting member comprises a working electrode, a reference electrode, and counter electrode, wherein only the working electrode is covered with a redox mediator.

10. The device of claim 1 said analyte detecting members use an amperometric measurement technique.

11. The device of claim 1 further comprising a mesh configured fluid spreader positioned over said analyte detecting member.

12. The device of claim 1 further comprising a hydrophilic membrane positioned over said analyte detecting member 4.53 cubic centimeters

13. The device of claim 1 wherein the cartridge has a higher density of analyte detecting members than 4.53 cubic centimeters divided by 17 per single analyte detecting member.

14. The device of claim 1 wherein the cartridge has a higher density of analyte detecting members than 4.53 cubic centimeters divided by 20 per single analyte detecting member.

15. The device of claim 1 wherein the cartridge has a higher density of analyte detecting members than 4.53 cubic centimeters divided by 25 per single analyte detecting member.

16. The device of claim 1 wherein the cartridge has a higher density of analyte detecting members than 4.53 cubic centimeters divided by 50 per single analyte detecting member.

17. A device for use with a body fluid sampling device for extracting bodily fluid from an anatomical feature, said device comprising:

a cartridge having a plurality of sample chambers;

a plurality of analyte detecting members;

wherein at least one of said analyte detecting members forms a portion of one wall of one of said plurality of sample chambers.

18. The device of claim 17 wherein said cartridge comprises a connector disc and an analyte detecting member disc.

19. A device for use with a body fluid sampling device for extracting bodily fluid from an anatomical feature, said device comprising:

a cartridge having a plurality of sample chambers;

a plurality of penetrating members each at least partially contained in said cavities of the single cartridge wherein the penetrating members are slidably movable to extend outward from openings on said cartridge to penetrate tissue;

a plurality of analyte detecting members;

wherein said chamber is positioned substantially adjacent an outer periphery of said cartridge;

at least one opening in one of said sample chambers leading fluid along a fluid path towards one of said analyte detecting members.

20. The device of claim 19 wherein said fluid path contains a channel sized to hold no more than 1 microliter.

21. A method for determining a concentration of an analyte in body fluid, comprising:

collecting a sample of body fluid of about 500 nL or less;

covering an electrochemical sensor with at least a portion of the sample;

determining the concentration of the analyte in the sample using a potentiometric technique.

22. A device comprising:

a plurality of analyte detecting members defining an array;

wherein at least two of said members have different sensitivity ranges enhancing the overall range of sensitivity of the array when used on a sample fluid.

23. A device comprising:

a single cartridge having a plurality of cavities;

a plurality of analyte detecting members defining an analyte array;

wherein at least two of said sensors have different sensitivity ranges enhancing the overall range of sensititiviy of the array when used on a sample fluid;

wherein said plurality of cavities each has one analyte array.

24. A system comprising:

an electric penetrating member driver;

a single cartridge having a plurality of cavities;

a plurality of penetrating members housed in said cavities and individually movable by said driver to penetrate tissue;

a plurality of analyte detecting members defining an analyte array;

wherein at least two of said sensors have different sensitivity ranges enhancing the overall range of sensitivity of the array when used on a sample fluid;

wherein said plurality of cavities each has one analyte array.