BODY FLUID SAMPLING DEVICE

• US 20110009774A1
• Filed: 09/10/2010
• Published: 01/13/2011
• Est. Priority Date: 03/06/2004
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Roe, Steven N., Calasso, Irio, Arnitz, Theo, Fuerst, Otto, List, Hans, Schmid, Wilifried, Griss, Patrick, Sarofim, Emad, Hasker, Dave, Jaeggi, Rainer, Haar, Hans-Peter, Zimmer, Volker, Kraemer, Uwe
• Granted Patent: US 8,814,808 B2
• Time in Patent Office: Days
• US Class Current: 600/583
• 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 5/150068 by tissue compression, e.g. with specially designed surface of device contacting the skin area to be pierced
• CPC Class Codes: A61B 5/150282 for piercing elements, e.g. blade, lancet, canula, needle
• 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 5/150396 Specific tip design, e.g. for improved penetration characteristics
• CPC Class Codes: A61B 5/150419 comprising means for capillary action
• CPC Class Codes: A61B 5/150427 Specific tip design, e.g. for improved penetration characteristics
• CPC Class Codes: A61B 5/15045 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 5/15151 Each piercing element being stocked in a separate isolated compartment
• CPC Class Codes: A61B 5/15163 Characterized by propelling the piercing element in an axial direction relative to the disc

Abstract

Body fluid sampling device comprising a skin-piercing element having a collection zone for receiving body fluid. In one embodiment, the collection zone includes a plurality of holes, e.g., 3 or more holes, or 50 to 100 holes. The hole size may be small, e.g., having a diameter of 0.01 to 0.5 mm. The holes may or may not extend through the lancet. In some embodiments, the holes have a depth of 50 to 500 μm. In other embodiments, the collection zone is porous, or is a roughened area. The collection zone can take up a very small volume of body fluid, e.g., 3 to 10 nL, in a very short time period, e.g., less than 0.5 seconds. In other embodiments, the device further comprises a fluid receiving means spaced apart from the collection zone so that body fluid in the collection zone will not contact the fluid receiving means initially.

Claims

1. Body fluid sampling device, comprising:

a skin-piercing element having a collection zone for receiving body fluid, wherein the collection zone comprises 3 or more holes in which the received body fluid is collected.

2. Device according to claim 1, wherein at least a portion of said collection zone is open to the environment.

3. Device according to claim 1, wherein the collection zone comprises a porous surface to receive the body fluid.

4. Device according to claim 1, wherein the volume of the body fluid received by the sampling device is 0.5 μ

L (microliters) or less.

5. Device according to claim 1, wherein the thickness of the skin-piercing element is below 500 μ

m (micrometers).

6. Device according to claim 5, wherein the thickness of the skin-piercing element is below 250 μ

m (micrometers).

7. Device according to claim 1, wherein the collection zone comprises 50 to 100 holes.

8. System for sample analysis with a device according to claim 1, further comprising:

a fluid receiving means with a test zone, wherein the thickness of the test zone is 10 to 80% of the depth of the holes in the fluid receiving zone of the skin-piercing element.

9. An apparatus, comprising:

a lancet adapted to penetrate the skin surface and obtain a sample of body fluid, the lancet including a plurality of holes forming a collection zone, wherein the diameter of each hole is 0.01 mm (millimeters) to 0.5 mm (millimeters).

10. The apparatus of claim 9 wherein the diameter of each hole is 20 μ

m (micrometers).

11. The apparatus of claim 9 wherein the depth of each hole is 50 to 500 μ

m (micrometers).

12. The apparatus of claim 9 wherein the plurality of holes includes 50 to 100 holes.

13. The apparatus of claim 9 wherein the sample volume of the collection zone is less than 0.5 μ

L (microliters).

14. The apparatus of claim 9 wherein the sample volume of the collection zone is 3 to 10 nL (nanoliters).

15. The apparatus of claim 9 wherein the holes extend through the lancet.

16. The apparatus of claim 9 wherein the holes do not extend through the lancet.

17. An apparatus, comprising:

a lancet adapted to penetrate a skin surface to obtain a sample of body fluid, the lancet including a collection zone adapted to hold a sample of bodily fluid as the lancet is withdrawn from the skin.

18. The apparatus of claim 17 wherein the collection zone is porous.

19. The apparatus of claim 17 wherein the collection zone is a roughened area on the surface of the lancet.

20. The apparatus of claim 17 wherein the collection zone includes a plurality of holes.

21. The apparatus of claim 17 wherein the collection zone includes 50 to 100 holes.

22. The apparatus of claim 17 wherein the collection zone includes a plurality of holes with a diameter of 0.01 mm (millimeters) to 0.5 mm (millimeters).

23. The apparatus of claim 17 wherein the collection zone includes a plurality of holes extending through the lancet.

24. The apparatus of claim 17 wherein the collection zone includes a plurality of holes that do not extend through the lancet.

25. The apparatus of claim 24 wherein the depth of the holes are 50 to 500 μ

m (micrometers).

26. The apparatus of claim 17 wherein the sample volume of the collection zone is 3 to 10 nL (nanoliters).

27. The apparatus of claim 17 wherein the collection zone is configured and adapted to fill with a sample of body fluid in less than 0.1 seconds.

28. The apparatus of claim 17 wherein the collection zone is configured and adapted to fill with a sample of body fluid in 1 to 10 ms (milliseconds).