METHOD AND DEVICE FOR SAMPLING AND ANALYZING INTERSTITIAL FLUID AND WHOLE BLOOD SAMPLES

• US 20080081976A1
• Filed: 10/29/2007
• Published: 04/03/2008
• Est. Priority Date: 03/27/2000
• Status: Abandoned Application

• Current Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Original Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Inventors: Hodges, Alastair, Chatelier, Ronald, Chambers, Garry
• Application Number:
  US11/926,510
• Publication Number:
  US 20080081976A1
• Time in Patent Office: Days
• US Class Current: 600/345
• CPC Class Codes: A61B 2010/008 Interstitial fluid
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157 disposable multilayered or laminated electrodes G01N27/307; details of handling chemical test elements G01N33/4875
• CPC Class Codes: A61B 5/14514 using means for aiding extraction of interstitial fluid, e.g. microneedles or suction
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• 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 5/150213 Venting means
• CPC Class Codes: A61B 5/150221 Valves
• 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 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• 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 5/150755 Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• CPC Class Codes: A61B 5/15105 Purely manual piercing, i.e. the user pierces the skin without the assistance of any driving means or driving devices
• 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 5/15117 comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
• CPC Class Codes: A61B 5/15142 Devices intended for single use, i.e. disposable
• CPC Class Codes: A61B 5/1519 comprising driving means, e.g. a spring, for propelling the piercing unit

Abstract

The invention disclosed in this application is a method and device for combining the sampling and analyzing of sub-dermal fluid samples, e.g., interstitial fluid or whole blood, in a device suitable for hospital bedside and home use. It is applicable to any analyte that exists in a usefully representative concentration in the fluid, and is especially suited to the monitoring of glucose.

Claims

1. A fluid sampling device comprising:

a body including;

a penetration probe having a penetrating end and a communicating end; and

an analysis chamber having a volume;

a releasable actuator adapted to receive the body, wherein the releasable actuator is capable of supplying a force sufficient to cause the penetration probe to penetrate a dermal layer of a user'"'"'s skin; and

a pressure sensor, the pressure sensor providing an indication that the penetration probe has penetrated the user'"'"'s skin.

2. The fluid sampling device of claim 1, wherein the penetration probe is in fluid communication with the analysis chamber such that fluid can flow from the penetration probe toward the analysis chamber.

3. The fluid sampling device of claim 1, wherein the fluid sampling device is adapted to limit the penetration of the penetrating end into the dermal layer to a depth of less than approximately 2 mm.

4. The fluid sampling device of claim 1, wherein the pressure sensor provides an indication that sufficient pressure has been applied to obtain a sample.

5. The fluid sampling device of claim 1, further comprising an interface for communication with a meter.

6. A fluid sampling system comprising:

a meter; and

a fluid sampling device, the fluid sampling device comprising;

an interface for communicating with the meter;

a body, the body including a dermal layer penetration probe having a penetrating end and a communicating end, the penetration probe having a volume; and

an analysis chamber having a proximal and distal end, the analysis chamber having a volume.

7. The fluid sampling system of claim 6, wherein the penetration probe is in fluid communication with the analysis chamber such that fluid can flow from the penetration chamber toward the analysis chamber.

8. The fluid sampling system of claim 6, wherein the penetration probe is capable of exerting a first capillary force and the analysis chamber is capable of exerting a second capillary force, and wherein a differential in capillary force exists between the first capillary force and the second capillary force.

9. The fluid sampling system of claim 6, wherein the fluid sampling device further comprises a pre-chamber having a volume and a first and second end, the pre-chamber interposed between the penetration probe and the analysis chamber such that the first end of the pre-chamber is adjacent the communicating end of the penetration probe and the second end of the pre-chamber is adjacent the proximal end of the analysis chamber.

10. The fluid sampling system of claim 6, wherein the volume of the pre-chamber is greater than the volume of the analysis chamber.

11. The fluid sampling system of claim 6, wherein the analysis chamber has at least one flexible wall and wherein upon compression of the chamber at the flexible wall the volume of the analysis chamber is reduced.

12. The fluid sampling system of claim 6, wherein the pre-chamber has at least one flexible wall and wherein upon compression of the pre-chamber at the flexible wall the volume of the pre-chamber is reduced.

13. The fluid sampling device of claim 6, wherein the fluid sampling device is adapted to limit the penetration of the penetrating end into the dermal layer to a depth of less than approximately 2 mm.

14. The fluid sampling system of claim 6, wherein the analysis chamber comprises an electrochemical cell, the cell comprising a working electrode and a counter/reference electrode.

15. The fluid sampling system of claim 6, wherein the meter is configured to display, store, or record test data.

16. A fluid sampling system comprising:

a meter; and

a fluid sampling device, the fluid sampling device comprising;

an interface for communicating with a meter;

a body including;

a penetration probe having a penetrating end and a communicating end;

an analysis chamber having a volume; and

a releasable actuator adapted to receive the test strip, wherein the releasable actuator is capable of supplying a force sufficient to cause the penetration probe to penetrate a dermal layer of a user'"'"'s skin; and

a pressure sensor, the pressure sensor providing an indication that the penetration probe has penetrated the user'"'"'s skin.

17. The fluid sampling system of claim 16, wherein the pressure sensor additionally provides an indication that sufficient pressure has been applied to obtain a sample.

18. The fluid sampling system of claim 16, wherein the penetration probe is in fluid communication with the analysis chamber such that fluid can flow from the penetration chamber toward the analysis chamber.

19. The fluid sampling system of claim 16, wherein the fluid sampling device further comprises a pre-chamber having a volume and a first and second end, the pre-chamber being interposed between the penetration probe and the analysis chamber such that the first end of the pre-chamber is adjacent the communicating end of the penetration probe and the second end of the pre-chamber is adjacent the proximal end of the analysis chamber.

20. The fluid sampling system of claim 16, wherein the volume of the pre-chamber is greater than the volume of the analysis chamber.

21. The fluid sampling system of claim 16, wherein the analysis chamber has at least one flexible wall and wherein upon compression of the chamber at the flexible wall the volume of the analysis chamber is reduced.

22. The fluid sampling system of claim 16, wherein the pre-chamber has at least one flexible wall and wherein upon compression of the pre-chamber at the flexible wall the volume of the pre-chamber is reduced.

23. The fluid sampling device of claim 16, wherein the fluid sampling device is adapted to limit the penetration of the penetrating end into the dermal layer to a depth of less than approximately 2 mm.

24. The fluid sampling system of claim 16, wherein the analysis chamber comprises an electrochemical cell, the cell comprising a working electrode and a counter/reference electrode.

25. The fluid sampling system of claim 16, wherein the meter is configured to display, store, or record test data.