Method and apparatus for an improved sample capture device

• US 8,945,910 B2
• Filed: 06/19/2012
• Issued: 02/03/2015
• Est. Priority Date: 09/29/2003
• Status: Active Grant

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Inventors: Marsot, Travis, Lum, Paul, Alden, Don, Ross, James, Bardell, Ron L., Weigl, Bernhard Hans
• Primary Examiner(s): SZMAL, BRIAN SCOTT
• Application Number:
  US13/526,882
• Publication Number:
  US 20120259186A1
• Time in Patent Office: 959 Days
• Field of Search: 600/583, 600/584, 606181-183, 382/128, 204/403.01, 738/632.1, 435/287.1
• US Class Current: 435/287.1
• CPC Class Codes: A61B 2560/0223 of calibration, e.g. protocols for calibrating sensors
• 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 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
• 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 5/150358 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 5/150572 Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
• CPC Class Codes: A61B 5/15107 Piercing being assisted by a triggering mechanism
• CPC Class Codes: A61B 5/15121 comprising piezos
• 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 5/15153 Multiple piercing elements stocked in a single 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: A61B 5/6848 Needles

Abstract

A body fluid sampling device is provided. A mesh (120) may be used to guide blood or fluid to travel directly form the wound to an analyte detecting port on the cartridge (121). Thus the volume of blood or body fluid produced at the wound site irregardless of its droplet geometry can be reliable and substantially completely transported to the analyte detecting member (150) for measurement.

Claims

1. A body fluid sampling device comprising:

an indexable cartridge;

a plurality of penetrating members positioned in the cartridge, the penetrating members movable to extend radially outward from the cartridge to penetrate tissue;

a plurality of analyte detecting members positioned in the cartridge, wherein at least one of the analyte detecting members positioned on the cartridge to receive body fluid from a wound in the tissue created by a penetrating member when the cartridge is in an operative position; and

a structure to draw fluid generated by the tissue towards one of the analyte detecting members; and

wherein an initial concentration (mm) of an analyte detecting member is;

[HO₂]=f_AqS_O2Aq+f_SiS_{O2 Si},

the effective partition coefficient is

2. The device of claim 1, wherein the cartridge is configured to be indexed in a manner that adjacent penetrating members can be used serially or sequentially.

3. The device of claim 1, further comprising:

a penetrating member driver.

4. The device of claim 3, further comprising:

a gripper configured to couple the penetrating member driver with a penetrating member.

5. The device of claim 4, wherein each one of a penetrating member has a notch or groove to facilitate coupling to the gripper.

6. The device of claim 3, wherein the penetrating member driver is in a same plane as the cartridge.

7. The device of claim 1, wherein the cartridge is a radial cartridge.

8. The device of claim 1, further comprising:

a support positioned in the cartridge that includes the plurality of analyte detecting members.

9. The device of claim 8, wherein the support includes a plurality of electrodes.

10. The device of claim 1 further comprising a ring around the cartridge wherein the analyte detecting members are mounted on the ring, along with the structure to draw fluid.

11. The device of claim 1 further comprising a ring around the cartridge wherein the analyte detecting members are coupled to the cartridge through the ring.

12. The device of claim 1 further comprising a plurality of electrodes coupled to the analyte detecting member.

13. A body fluid sampling device comprising:

a housing;

a cartridge positionable and removable from the housing;

a plurality of penetrating members positioned in the cartridge and operatively couplable to a penetrating member driver;

a plurality of analyte detecting members positioned in the cartridge, wherein at least one of the analyte detecting members positioned on the cartridge to receive body fluid from a wound in the tissue created by a penetrating member when the cartridge is in an operative position, the plurality of penetrating members and plurality of analyte detecting members positioned in the cartridge; and

a movement structure that moves penetrating members in the cartridge into positions for launching of penetrating members to create a tissue penetration event; and

wherein an initial concentration (mm) of an analyte detecting member is;

[HO₂]=f_AqS_O2Aq+f_SiS_{O2 Si},

the effective partition coefficient is

14. The device of claim 13, wherein the cartridge is configured to be indexed in a manner that adjacent penetrating members can be used serially or sequentially.

15. The device of claim 13, further comprising:

a penetrating member driver.

16. The device of claim 15, further comprising:

a gripper configured to couple the penetrating member driver with a penetrating member.

17. The device of claim 16, wherein each of a penetrating member has a notch or groove to facilitate coupling to the gripper.

18. The device of claim 15, wherein the penetrating member driver is in a same plane as the cartridge.

19. The device of claim 13, wherein the cartridge is a radial cartridge.

20. The device of claim 13, further comprising:

a support positioned in the cartridge that includes the plurality of analyte detecting members.

21. The device of claim 20, wherein the support includes a plurality of electrodes.

22. The device of claim 13, further comprising a ring around the cartridge wherein the analyte detecting members are mounted on the ring, along with the structure to draw fluid.

23. The device of claim 13, further comprising a ring around the cartridge wherein the analyte detecting members are coupled to the cartridge through the ring.

24. The device of claim 13, further comprising a plurality of electrodes coupled to the analyte detecting member.