Body fluid sampling device

• US 8,814,808 B2
• Filed: 09/10/2010
• Issued: 08/26/2014
• 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: Calasso, Irio Guiseppe, Griss, Patrick, Sarofim, Emad, Jaeggi, Rainer, Kraemer, Uwe, Hasker, Dave, Zimmer, Volker, Schmid, Wilifried, Fuerst, Otto, List, Hans, Haar, Hans-Peter, Arnitz, Theo, Roe, Steven N.
• Primary Examiner(s): Dougherty, Sean
• Assistant Examiner(s): Stout, Michael C
• Application Number:
  US12/879,500
• Publication Number:
  US 20110009774A1
• Time in Patent Office: 1,446 Days
• Field of Search: 600/583, 606181-183
• 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. A body fluid system, comprising:

a skin-piercing element having a sharpened end for piercing tissue and a collection zone for receiving body fluid from the tissue, wherein the thickness of the skin-piercing element is below 500 μ

m and the collection zone comprises 3 or more blind holes open to the environment for receiving the body fluid; and

a test zone for receiving body fluid from the collection zone of said skin-piercing element.

2. The system according to claim 1, wherein the sample volume of the collection zone is less than 0.5 μ

L (microliters).

3. The system according to claim 1, wherein the thickness of the skin-piercing element is below 250 μ

m (micrometers).

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

15. The sampling system of claim 1 and further comprising:

a meter with a detection unit for receiving signals from said test zone to determine the presence and/or concentration of an analyte in the body fluid based on the received signals.

5. A testing system comprising:

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

a test zone for receiving body fluid from the collection zone of said lancet.

6. The system of claim 5 wherein the depth of each hole is 50 to 500 μ

m (micrometers).

7. The apparatus of claim 5 wherein the plurality of holes includes 50 to 100 blind holes.

8. The system of claim 5 wherein the sample volume of the collection zone is less than 0.5 μ

L (microliters).

9. The apparatus of claim 5 wherein the sample volume of the collection zone is 3 to 10 nL (nanoliters).

16. The system of claim 5 and further comprising:

a meter with a detection unit for receiving signals from said test zone to determine the presence and/or concentration of an analyte in the body fluid based on the received signals.

10. A testing system comprising:

a lancet having a sharpened end 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, wherein the collection zone includes a plurality of blind holes open to the environment and having diameters of 0.01 mm to 0.5 mm; and

a test zone for receiving body fluid from the collection zone of said lancet.

11. The apparatus of claim 10 wherein the collection zone includes 50 to 100 blind holes.

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

13. The system of claim 10 wherein the collection zone is configured and adapted to fill with a sample of body fluid in less than 0.1 seconds.

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

17. A testing system comprising:

a lancet having a sharpened end 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, wherein the collection zone includes a plurality of blind holes open to the environment and having depths of 50 to 500 μ

m; and

a test zone for receiving body fluid from the collection zone of said lancet.

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

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

20. The system 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.

21. The system of claim 17 wherein the collection zone is configured and adapted to fill with a sample of body fluid in 1 to 10 ms.