Method and apparatus for analyte detecting device

• US 9,386,944 B2
• Filed: 04/10/2009
• Issued: 07/12/2016
• Est. Priority Date: 04/11/2008
• Status: Active Grant

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Inventors: Freeman, Dominique, Boecker, Dirk, Alden, Don
• Primary Examiner(s): HENSON, DEVIN B
• Application Number:
  US12/421,776
• Publication Number:
  US 20090259146A1
• Time in Patent Office: 2,650 Days
• Field of Search: 600/573, 600/583, 606181-183
• US Class Current: 1/1
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157
• 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 5/150152 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 5/150259 Improved gripping, e.g. with high friction pattern or projections on the housing surface or an ergonometric shape
• CPC Class Codes: A61B 5/150419 comprising means for capillary action
• 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 5/150572 Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
• CPC Class Codes: A61B 5/150702 fully automatically removed, i.e. the removing does not require any action by the user
• CPC Class Codes: A61B 5/150946 Means for varying, regulating, indicating or limiting the speed or time of blood collection
• 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 5/15146 Devices loaded with multiple lancets simultaneously, e.g. for serial firing without reloading, for example by use of stocking means. multiple simultaneous cutting or piercing A61B5/150977
• 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

An integrated analyte measurement system includes a housing and a disposable configured to be positioned in the housing. A plurality of penetrating members are positioned in the disposable. A penetrating member driver is configured to be coupled to each of a penetrating member. A plurality of analyte sensors are positioned in the disposable. The disposable houses both used and unused penetrating members and analyte sensors.

Claims

1. An integrated analyte measurement system, comprising:

a housing;

a disposable configured to be positioned in the housing;

a plurality of penetrating members positioned in the disposable;

a driver configured to be coupled to the penetrating member, the driver coupled to a processor and having position and velocity sensing capabilities to advance a penetrating member into a target tissue to create a wound from which body fluid will flow, the processor and driver providing control of drive power to a penetrating member and velocity of the penetrating member to account for variations in a skin thickness during advance of the penetrating member to create the wound; and

a plurality of analyte sensors positioned in the disposable, the disposable housing used and unused penetrating members as well as analyte sensors.

2. The system of claim 1, wherein the driver is an electromechanical driver.

3. The system of claim 1, wherein the system provides for electronic control of penetrating member trajectory during skin cutting.

4. The system of claim 1, further comprising:

a display; and

a user interface.

5. The system of claim 1, further comprising:

a shutter that covers at least a portion of a front end of the housing.

6. The system of claim 5, wherein a testing mode of the system is initiated by opening the shutter.

7. The system of claim 1, further comprising:

resources that include a microprocessor which provides at least one of, data processing, calibration curves and look-up tables.

8. The system of claim 1, further comprising:

at least one indexer for indexing the plurality of analyte sensors and penetrating members.

9. The system of claim 1, wherein the housing includes a front end with a skin stabilizer.

10. The system of claim 1, wherein the plurality of penetrating members are coupled to a support, the support being coupled to a frame that includes the plurality of analyte sensors.

11. The system of claim 1, further comprising:

at least one sterility seal and at least one humidity seal.

12. The system of claim 11, further comprising:

an opening member for opening at least one of, the at least one sterility seal and the humidity seal.

13. The system of claim 1, further comprising:

a desiccant positioned in an interior of at least one of the housing and the disposable.

14. The system of claim 3, wherein the electronic control provides for control of penetrating member position and velocity profile during an entire lancing process of the penetrating member.

15. The system of claim 3, wherein the system has an electronic brake for each of a penetrating member.

16. The system of claim 3, wherein the system provides for control of drive power to a penetrating member and a lancing speed to account for variations in skin thickness.

17. The system of claim 1, wherein each of an analyte sensor includes three electrodes positioned in a sample chamber.

18. The system of claim 1, wherein each analyte sensor is a glucose sensor with three electrodes positioned in a sample chamber.

19. The system of claim 18, wherein a mediator is included as part of a working electrode.

20. The system of claim 19, wherein the mediator is not a separate element from the working electrode.

21. The system of claim 18, wherein each glucose sensor includes a conductive layer, insulating layer, a reference electrode, a counter electrode and a working electrode.

22. The system of claim 21, wherein each glucose sensor includes a hydrophilic membrane, spacer layer and adhesive layer.

23. The system of claim 18, wherein the analyte sensors are screen-printed.

24. The system of claim 23, wherein a carbon paste is provided on top of a substrate to form conducting layers for a screen-printed three-electrode system.

25. The system of claim 1, wherein during sample acquisition and measurement a tip of a penetrating member remains within an associated analyte sensor.