Method and apparatus for analyte measurement test time

• US 20090054811A1
• Filed: 12/30/2005
• Published: 02/26/2009
• Est. Priority Date: 12/30/2004
• Status: Abandoned Application

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Inventors: Boecker, Dirk
• Application Number:
  US11/813,014
• Publication Number:
  US 20090054811A1
• 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 5/150175 Adjustment of penetration depth
• 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 5/150503 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 5/15113 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 5/15182 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 the analyte measurement by a user using an analyte measurement device. A penetrating member and unused analyte detecting member of the analyte measurement device are presented into an active position. The penetrating member is fired to prick the skin and bring a fluid sample to the analyte detecting member. The analyte level is measured. These three steps occur in less than 10 seconds.

Claims

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

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

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

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

2. The method of claim 1, further comprising:

displaying the analyte level to the user

3. The method of claim 1, further comprising:

storing a value of the analyte level.

4. The method of claim 1, wherein steps (a) through (d) occur in less than 7 seconds

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

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

7. The method of claim 1, wherein blood is applied to an analyte detection member during lancing.

8. The method of claim 7, 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.

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

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

11. 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.

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

13. The method of claim 1 further comprising:

returning the device to a storage condition without having to dispose of a used penetrating member or used analyte detecting members.

14. The method of claim 1 wherein the device is ready for the next lancing event without having to dispose of the used penetrating member or the used analyte detecting member.

15. 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.

34. The method of claim 14 wherein there is no disposal of a used analyte detecting member and a used penetrating member after each lancing step.

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

(a) making a decision to test;

(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;

(d) measuring the analyte level, and

wherein steps (a) through (d) occur in no more than 1 minute.

17. The method of claim 16, wherein steps (a) through (d) occur in no more than 30 seconds.

18. The method of claim 16, wherein steps (a) through (d) occur in no more than 15 seconds.

19. The method of claim 16, wherein steps (a) through (d) occur in no more than 10 seconds.

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

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

(b) 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;

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

(d) measuring the analyte levels; and

wherein steps (a) through (d) are completed in no more than 10 seconds.

21. The method of claim 20, further comprising:

displaying the analyte level to the user

22. The method of claim 20, further comprising:

storing a value of the analyte level.

23. The method of claim 20, wherein steps (a) through (d) are performed without the user directly handling the penetrating member to obtain a fresh penetrating member or load the penetrating member

24. The method of claim 20, wherein steps (a) through (d) are performed without the user coding the analyte measurement device.

25. The method of claim 20, wherein blood is applied to an analyte detection member during lancing.

26. The method of claim 25, 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.

27. The method of claim 20, wherein steps (a) through (d) are performed without a separate step of apply blood to a analyte detection member after lancing.

28. The method of claim 20, wherein steps (b) and (c) are performed without milking a wound.

29. The method of claim 20, wherein steps (b) and (c) are performed using at least one of a penetrating member drivers selected from, spring based, electromechanical based, magnetic driver based, and nanomuscle based.

30. The method of claim 20, wherein step (c) is performed with controlled velocity and depth of penetration.

31. The method of claim 20, further comprising:

returning the device to a storage condition without having to dispose of a used penetrating member or used analyte detecting members.

32. The method of claim 20, wherein the device is ready for the next lancing event without having to dispose of the used penetrating member or the used analyte detecting member.

33. The method of claim 20, wherein a time from pressing an on button of the device to lancing and measuring the analyte level is no more than 10 seconds.

35. The method of claim 20, wherein steps (a) through (d) are performed without a disposal or handling of waste step.