Method and apparatus using optical techniques to measure analyte levels

• US 20120264204A1
• Filed: 06/26/2012
• Published: 10/18/2012
• Est. Priority Date: 12/30/2002
• Status: Active Grant

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Inventors: Freeman, Dominique M., Jones, Robert, Cullen, David, Owen, Michael J., Dryer, Christopher, Boccker, Dirk, MacLood, Malcom, Carlson, William
• Granted Patent: US 9,034,639 B2
• Time in Patent Office: Days
• US Class Current: 435/288.7
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• 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 5/150274 Manufacture or production processes or steps for blood sampling devices
• 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 5/150503 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 5/15113 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 5/1513 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 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: B01L 2200/027 : for microfluidic devices
• CPC Class Codes: B01L 2300/0803 : Disc shape
• CPC Class Codes: B01L 2300/0887 : Laminated structure
• CPC Class Codes: B01L 2400/0406 : capillary forces
• CPC Class Codes: B01L 3/5025 : for parallel transport of multiple samples
• CPC Class Codes: B01L 3/502715 : characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces
• CPC Class Codes: G01N 21/6408 : with measurement of decay time, time resolved fluorescence

Abstract

A device is provided for use with a tissue penetrating system and/or a metering device for measuring analyte levels. The device comprises a cartridge and a plurality of analyte detecting members mounted on the cartridge. The cartridge may have a radial disc shape. The cartridge may also be sized to fit within the metering device. The analyte detecting members may be optical system using fluorescence lifetime to determine analyte levels. In one embodiment, the device may also include a fluid spreader positioned over at least a portion of the 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 in a metering device for measuring analyte levels in a sample fluid, said device comprising:

a housing;

a controllable electronic driver;

a plurality of penetrating members;

a cartridge;

a plurality of analyte detecting members positioned on an analyte detecting member support that is positionable in the cartridge and each of an analyte detecting member being associated with a penetrating member, each of an analyte detecting member providing an indicator of analyte levels in said sample fluid; and

the analyte detecting member support being moveable in the cartridge so as to be able to move and present new, unused analyte detecting members in sequence with new unused penetrating members of cartridge.

2. The device of claim 1, further comprising:

a penetrating member sensor.

3. The device of claim 1, further comprising:

a processor coupled to the controllable electronic driver.

4. The device of claim 3, further comprising:

a feedback loop coupled to the processor.

5. The device of claim 3, wherein processor includes control instructions for the penetrating member driver.

6. The device of claim 5, wherein the processor includes a memory for storage and retrieval of a set of penetrating member profiles.

7. The device of claim 1, further comprising:

a first seal formed between the plurality of penetrating members and the cartridge.

8. The device of claim 7, further comprising:

a second seal located at least one of the distal port or proximal port of cartridge.

9. The device of claim 1, wherein each penetrating member is an elongated member without molded attachments.

10. The device of claim 1, further comprising:

a penetrating member transport device for moving each of a penetrating member into a position aligned with the penetrating member driver.

11. The device of claim 1, further comprising:

a belt for holding the penetrating members in an array configuration.

12. The device of claim 1, further comprising:

a tape device configured to hold the penetrating members in an array configuration.

13. The device of claim 1, further comprising:

a support channel configured to hold the penetrating members in an array configuration.

14. The device of claim 1, further comprising:

a cog configured to hold the penetrating members in an array configuration.

15. The device of claim 1, further comprising:

a plurality of connectors between penetrating members for holding the penetrating members in an array configuration.

16. The device of claim 1, further comprising:

a support structure for receiving the penetrating members.

17. The device of claim 16, wherein the support structure is a bandolier.

18. The device of claim 16, wherein the support structure is a drum.

19. The device of claim 16, wherein the support structure is a disc.