Body fluid sampling device

• US 7,819,822 B2
• Filed: 09/06/2006
• Issued: 10/26/2010
• Est. Priority Date: 03/06/2004
• Status: Expired due to Fees

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: List, Hans, Griss, Patrick, Calasso, Irio Guiseppe, Roe, Steven N., Arnitz, Theo, Fuerst, Otto, Sarofim, Emad, Hasker, Dave, Jaeggi, Rainer, Schmid, Wilfried, Haar, Hans-Peter, Zimmer, Volker, Kraemer, Uwe
• Primary Examiner(s): Hindenburg; Max
• Assistant Examiner(s): Stout; Michael C
• Application Number:
  US11/470,368
• Publication Number:
  US 20070016103A1
• Time in Patent Office: 1,511 Days
• Field of Search: 600/573, 600/583, 606/181, 606/183
• 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, and the device further comprising a fluid receiving means remote spaced apart from the collection zone so that body fluid in the collection zone will not contact the fluid receiving means initially. The collection zone takes up a very small volume of body fluid of about 10 to 500 nl in a very short time period of less than 0.5 seconds. The fluid receiving means may have a test zone for performing an analytical reaction. Fluid sample from the collection zone is automatically or manually transported to the fluid receiving means to contact the fluid with the test zone.

Claims

1. Body fluid sampling device, comprising:

a skin-piercing element having a sharpened end for piercing tissue and a collection zone for receiving body fluid from the tissue, the collection zone being exposed to the outside environment at the sharpened end of the skin-piercing element;

a fluid receiving element connected to the skin-piercing element and comprising a test zone;

the collection zone of the skin-piercing element being adapted to retain a sample of body fluid at the sharpened end and in isolation from the fluid receiving element when piercing the tissue; and

the fluid receiving element being configured to contact the collection zone at the sharpened end of the skin-piercing element, when contacting the fluid receiving element, the collection zone transfers the body fluid directly to the fluid receiving element.

2. The device of claim 1, further comprising:

the skin-piercing element and the fluid receiving element extending in a parallel manner with respect to one another; and

the fluid receiving element being configured to contact the collection zone of the skin-piercing member in a perpendicular manner.

3. The device of claim 1, further comprising:

the fluid receiving element being received in a chamber; and

the fluid receiving element being stored in a bent state inside the chamber to contact the collection zone of the skin-piercing element when the fluid receiving element is extended from the chamber.

4. The device of claim 1, in which the fluid volume needed for measurement does not increase by increasing the distance between the collection zone and the fluid receiving element.

5. The device of claim 1, further comprising:

a controller configured to move the skin-piercing element and the fluid receiving element from a non-contacting orientation to a contacting orientation;

wherein at the non-contacting orientation the skin-piercing element and the fluid receiving element are spaced apart from one another; and

wherein at the contacting orientation the skin-piercing element and the fluid receiving element are contacting one another.

6. The device of claim 1, in which the skin-piercing element is solid.

7. The device of claim 1, wherein the collection zone comprises holes in which the body fluid is collected.

8. The device of claim 7, wherein the holes are blind holes.

9. The device of claim 7, wherein the holes are through holes.

10. The device of claim 1, wherein the collection zone comprises a porous surface to receive the body fluid.

11. The device of claim 1, wherein the collection zone is a discrete structure configured to retain the discrete sample only at the sharpened end.

12. The device of claim 1, wherein the collection zone is adapted to retain at most 0.5 μ

l of body fluid.

13. The device of claim 1, wherein the device further comprises expression means.

14. The device of claim 13, wherein the expression means comprises a finger cone.

15. The device of claim 1, further comprising:

a magazine in which the skin-piercing element and the fluid receiving element are arranged.

16. The device of claim 15, wherein the magazine includes a skin-piercing element drum in which the skin-piercing element is received and a test strip drum in which the fluid receiving element is received, the skin-piercing element drum and the test strip drum being arranged in a concentric manner.

17. The device of claim 16, wherein the test strip drum is received around the skin-piercing element drum.

18. The device of claim 16, wherein the skin-piercing element and the fluid receiving element are each mounted on respective sliders that have an external grip.

19. The device of claim 18, further comprising:

the test strip drum defining a chamber in which the fluid receiving element is received; and

the fluid receiving element being bent to contact the collection zone of the skin-piercing element when the fluid receiving element is extended from the chamber.

20. The device of claim 19, further comprising:

a foil sealing the chamber.

21. The device of claim 1, wherein the fluid receiving element is bent to contact the collection zone of the skin-piercing element when the fluid receiving element is extended.

22. The device of claim 1, wherein skin-piercing element includes a solid lancet with a groove that forms the collection zone.

23. The device of claim 1, further comprising a cartridge connected to the skin-piercing element and connected to the fluid receiving element, wherein the skin-piercing element and the fluid receiving element are connected to one another through their individual connections to the cartridge.

24. Body fluid sampling device, comprising:

a skin-piercing element having a sharpened end for piercing tissue and a collection zone for receiving body fluid from the tissue, the collection zone being exposed to the outside environment at the sharpened end of the skin-piercing element;

a fluid receiving element connected to the skin-piercing element and comprising a test zone;

the skin-piercing element lacking a fluid path for directly transporting the body fluid from the collection zone to the fluid receiving element when piercing the tissue, the collection zone being isolated at the sharpened end and configured to retain a sample of the body fluid at a discrete location at the sharpened end, the discrete location terminating before fluidically connecting with the fluid receiving element when the skin-piercing element is piercing the tissue;

the skin-piercing element and the fluid receiving element extending in a parallel manner with respect to one another; and

the fluid receiving element being configured to contact the collection zone of the skin-piercing member in a perpendicular manner.

25. The device of claim 24, further comprising:

the fluid receiving element being received in a chamber; and

the fluid receiving element being stored in a bent state inside the chamber to contact the collection zone of the skin-piercing element when the fluid receiving element is extended from the chamber.

26. The device of claim 24, in which the fluid volume needed for measurement does not increase by increasing the distance between the collection zone and the fluid receiving element.

27. The device of claim 24, further comprising:

a controller configured to move the skin-piercing element and the fluid receiving element from a non-contacting orientation to a contacting orientation;

wherein at the non-contacting orientation the skin-piercing element and the fluid receiving element are spaced apart from one another; and

wherein at the contacting orientation the skin-piercing element and the fluid receiving element are contacting one another.

28. The device of claim 24, in which the skin-piercing element is solid.

29. The device of claim 24, wherein the collection zone comprises holes in which the body fluid is collected.

30. The device of claim 29, wherein the holes are blind holes.

31. The device of claim 29, wherein the holes are through holes.

32. The device of claim 24, wherein the collection zone comprises a porous surface to receive the body fluid.

33. The device of claim 24, wherein the collection zone is a discrete structure configured to retain the discrete sample only at the sharpened end.

34. The device of claim 24, wherein the collection zone is adapted to retain at most 0.5 μ

l of body fluid.

35. The device of claim 24, wherein the device further comprises expression means.

36. The device of claim 35, wherein the expression means comprises a finger cone.

37. The device of claim 24, further comprising:

a magazine in which the skin-piercing element and the fluid receiving element are arranged.

38. The device of claim 37, wherein the magazine includes a skin-piercing element drum in which the skin-piercing element is received and a test strip drum in which the fluid receiving element is received, the skin-piercing element drum and the test strip drum being arranged in a concentric manner.

39. The device of claim 38, wherein the test strip drum is received around the skin-piercing element drum.

40. The device of claim 38, wherein the skin-piercing element and the fluid receiving element are each mounted on respective sliders that have an external grip.

41. The device of claim 40, further comprising:

the test strip drum defining a chamber in which the fluid receiving element is received; and

the fluid receiving element being bent to contact the collection zone of the skin-piercing element when the fluid receiving element is extended from the chamber.

42. The device of claim 41, further comprising:

a foil sealing the chamber.

43. The device of claim 24, wherein the fluid receiving element is bent to contact the collection zone of the skin-piercing element when the fluid receiving element is extended.

44. The device of claim 24, wherein skin-piercing element includes a solid lancet with a groove that forms the collection zone.

45. The device of claim 24, further comprising a cartridge connected to the skin-piercing element and connected to the fluid receiving element, wherein the skin-piercing element and the fluid receiving element are connected to one another through their individual connections to the cartridge.