Method and apparatus for analyte measurement test time

• US 20080214917A1
• Filed: 03/26/2008
• Published: 09/04/2008
• Est. Priority Date: 12/30/2004
• Status: Abandoned Application

• Current Assignee: Pelikan Technologies, Inc.
• Original Assignee: Pelikan Technologies, Inc.
• Inventors: Boecker, Dirk
• Application Number:
  US12/056,017
• Publication Number:
  US 20080214917A1
• Time in Patent Office: Days
• US Class Current: 600/347
• 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 5/15016 by accessories for bringing the piercing element into the body, e.g. through rotation of the piercing element
• 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 5/150175 Adjustment of penetration depth
• CPC Class Codes: A61B 5/150213 Venting means
• 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 5/150427 Specific tip design, e.g. for improved penetration characteristics
• 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 5/150916 by blocking components, e.g. piston, driving device or fluid passageway
• CPC Class Codes: A61B 5/15123 comprising magnets or solenoids
• 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 5/15182 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

Abstract

A method is provided for analyte measurement by a user using an analyte measurement device. An analyte measurement is provided with a plurality of penetrating members and analyte sensors. Each analyte sensor is positioned in a sample chamber with a volume no greater than 1 μl. Each sample chamber has a working electrode, reference electrode and a counter electrode. The working electrode has a conductor, an enzyme and a mediator. A penetrating member and an unused analyte detecting member are presented into an active position. The following steps are then performed: (a) the penetrating member is fired to prick the skin and bring a fluid sample to the analyte detecting member, (b) the analyte level is measured, and (c) it takes no more than 10 seconds from the step of presenting the penetrating members and unused analyte into the active position through the step of measuring the analyte level.

Claims

1. A method of analyte measurement by a user using an analyte measurement device, comprising:

(a) providing an analyte measurement with a plurality of penetrating members and analyte sensors, each of an analyte sensor positioned in a sample chamber with a volume no greater than 1 μ

l, each of a sample chamber including a working electrode, reference electrode and a counter electrode, the working electrode having a conductor, an enzyme and a mediator;

(b) presenting a penetrating member and unused analyte detecting member of the analyte measurement device into an active position;

(c) firing the penetrating member to prick the skin and bring a fluid sample to the analyte detecting member; and

(d) measuring the analyte level, wherein steps (b) through (d) occur in less than 10 seconds.

2. The method of claim 1, wherein the conductor, mediator and enzyme are in a single layer of the working electrode.

4. The method of claim 1, wherein the analyte includes glucose.

5. The method of claim 1, wherein analyte is in a blood sample.

6. The method of claim 5, wherein the reagent interacts with glucose to produce an electroactive reaction product.

7. The method of claim 5, wherein electroactive reaction product is correlated to a concentration of glucose in the blood sample.

8. The method of claim 5, further comprising:

displaying the glucose level to the user.

9. The method of claim 1, further comprising:

storing a value of the analyte level.

10. The method of claim 1, wherein steps (b) through (c) occur in less than 7 seconds

11. The method of claim 1, wherein steps (b) through (c) are performed without the user directly handling the penetrating member to obtain a fresh penetrating member or load the penetrating member

12. The method of claim 1, wherein steps (b) through (c) are performed without the user coding the analyte measurement device.

13. The method of claim 1, wherein the application of blood to an analyte detection member during lancing occurs without removal and disposal of penetrating members from the analyte measurement device.

14. The method of claim 1, wherein steps (b) through (c) are performed without a separate step of apply blood to a analyte detection member after lancing.

15. The method of claim 1, wherein step (b) is performed without milking a wound.

16. The method of claim 1, wherein step (b) is performed using at least one of a penetrating member driver selected from, spring based, electro-mechanical based, magnetic driver based, and nanomuscle based.

17. The method of claim 1, wherein step (b) is performed with controlled velocity and depth of penetration.

18. The method of claim 1 wherein a time from pressing an on button of the device to lancing and measuring the analyte level is no more than 10 seconds.

3. The method of claim 3, wherein each of a working electrode includes a layer that has a conductor, a reagent and a mediator.

19. A method of analyte measurement by a user using an analyte measurement device, comprising:

(a) providing an analyte measurement with a plurality of penetrating members and analyte sensors, each of an analyte sensor positioned in a sample chamber with a volume no greater than 1 μ

l, each of a sample chamber including a working electrode, reference electrode and a counter electrode, the working electrode having a conductor, an enzyme and a mediator;

(b) making a decision to test;

(c) presenting a penetrating member and unused analyte detecting member of the analyte measurement device into an active position;

(d) firing the penetrating member to prick the skin and bring a fluid sample to the analyte detecting member;

(e) measuring the analyte level, and wherein steps (b) through (e) occur in no more than 1 minute.

20. The method of claim 19, wherein the conductor, mediator and enzyme are in a single layer of the working electrode.

21. The method of claim 19, wherein steps (b) through (e) occur in no more than 30 seconds.

22. The method of claim 19, wherein steps (b) through (e) occur in no more than 15 seconds.

23. The method of claim 19, wherein steps (b) through (e) occur in no more than 10 seconds.

24. A method of analyte measurement performed by an analyte measurement device, the method comprising:

(a) providing an analyte measurement with a disposable device that includes plurality of penetrating members and analyte sensors, each of an analyte sensor positioned in a sample chamber with a volume no greater than 1 μ

l, each of a sample chamber including a working electrode, reference electrode and a counter electrode, the working electrode having a conductor, an enzyme and a mediator;

(b) presenting a penetrating member and unused analyte detecting member of the analyte measurement device into an active position by rotating the disposable device to align in the active position, removing seals covering the penetrating member and analyte detecting member;

(c) firing the penetrating member to prick the skin using a driver to advance and retract from the skin to create a wound from which body fluid expresses;

(d) bringing a fluid sample to the analyte detecting member by providing a sample capture structure positioned to contact body fluid expressed from the wound;

(e) measuring the analyte levels; and

wherein steps (b) through (e) are completed in no more than 10 seconds.

25. The method of claim 24, wherein a time from pressing an on button of the device to lancing and measuring the analyte level is no more than 10 seconds.