BODY FLUID SAMPLING DEVICE

• US 20070016103A1
• Filed: 09/06/2006
• Published: 01/18/2007
• 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, Arnitz, Theo, Fuerst, Otto, Roe, Steven, List, Hans, Jaeggi, Rainer, Schmid, Wilfried, Haar, Hans-Peter, Zimmer, Volker, Kraemer, Uwe, Griss, Patrick, Sarofim, Emad, Hasker, Dave
• Granted Patent: US 7,819,822 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, 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 collection zone for receiving body fluid, wherein at least a portion of said collection zone is open to the environment and

a fluid receiving means comprising a test zone and being spaced from said collection zone so that the fluid receiving means being out of fluidic contact with said collection zone, so that fluid present in said collection zone will not contact the fluid receiving means.

2. Device according to claim 1, wherein said device being adapted to undergo a physical change upon actuation so as to assume a contacting state in which a fluid in said collection zone contacts said fluid receiving means.

3. Device according to claim 2, wherein said device having a moveable portion which can be moved and at least a portion of said collection zone is located on said moveable portion.

4. Device according to claim 1, wherein body fluid received in said collection zone is moved onto the fluid receiving means by electrical actuation.

5. Device according to claim 1, wherein the body fluid received in said collection zone is transferred to contact the fluid receiving means without using body fluid as transport means.

6. Device according to claim 1, wherein the collection zone comprises holes in which the received body fluid is collected.

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

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

l or less.

9. Device according to claim 1, wherein the device further comprises expression means.

10. Device according to claim 9, wherein the expression means comprises a finger cone.

11. System for body fluid analysis comprising

a skin-piercing element with a collection zone for receiving body fluid, wherein at least a portion of said collection zone is open to the environment and

a fluid receiving means remote from said collection zone so that the fluid receiving means being out of fluidic contact with said collection zone, so that fluid present in said pathway will not contact the fluid receiving means,

said fluid receiving means comprising a test zone.

12. System according to claim 11, comprising a contacting means which contacts a portion of the collection zone of the skin-piercing means with the fluid receiving means to provide the test zone with sample fluid.

13. System according to claim 11, wherein the collection zone receives a body fluid sample while at least a portion of the collection zone is in the body.

14. System according to claim 11, wherein the collection zone is located at the tip of the skin-piercing element and the collection zone is completely introduced into the body.

15. System according to claim 11, wherein the system comprises means to adjust temperature of the test zone to a temperature in the range of 20°

C. to 40°

C.

16. System according to claim 12, wherein said skin-piercing means has a moveable portion and said contacting means applies a force to said moveable portion to move at least a portion of the collection zone into contact with the fluid receiving means.

17. System according to claim 11, comprising a drive means for driving the skin-piercing means into skin to pierce the skin for obtaining a body fluid sample.

18. System according to claim 12, wherein said contacting means comprises voltage means for applying an electrical potential between said collection zone and said fluid receiving means so that fluid from said collection zone contacts fluid receiving means.

19. System according to claim 11, further comprising a transport means for transporting the skin-piercing element relative to the fluid receiving means.

20. System according to claim 12, wherein said contacting means comprise ultrasound means to force the body fluid sample in said collection zone so that fluid from said collection zone contacts said fluid receiving means.

21. System according to claim 11, wherein the time the skin-piercing element remains in the body to receive the body fluid sample is less than 0.5 sec.

22. System according to claim 11, further comprising:

a transport means to bring the skin-piercing element into contact with the fluid receiving means, and

a detection unit for receiving signals from said fluid receiving means to determine the presence and/or concentration of an analyte in the body fluid sample.

23. System according to claim 22, wherein the transport means comprises electrical actuation.

24. System according to claim 22, wherein the transport means comprises spring force actuation.

25. System according to claim 22, wherein the transport means comprises manual actuation.

26. System according to claim 22, wherein the transport means comprises a combination of electrical, spring force or manual actuation.

27. System according to claim 22, further comprising a magazine for storing multiple fluid receiving means.

28. Method for determining an analyte concentration in body fluid comprising the steps of:

a) receiving body fluid in a collection zone of a skin-piercing element,

b) contacting the collection zone of the skin-piercing element with the fluid receiving means so that body fluid reaches a test zone on the fluid receiving means,

c) receiving signals from said test zone which are characteristic for an analyte concentration

d) processing said signals to determine the analyte concentration.

29. Method according to claim 28 further comprising pricking skin with said skin-piercing element.

30. Method according to claim 28, wherein the skin-piercing element is transferred by transport means to the fluid receiving means to contact the skin-piercing means with the fluid receiving means.

31. Method according to claim 28, wherein the skin-piercing element is transferred automatically to the fluid receiving means to contact the skin-piercing element with the fluid receiving mean.

32. Method according to claim 28, wherein the skin-piercing element is transferred manually to the fluid receiving means to contact the skin-piercing element with the fluid receiving mean.

33. Method according to claim 28, wherein the time of the skin-piercing element remaining in the body to receive the body fluid sample is less than 0.5 sec.

34. Method for body fluid sampling comprising the steps of:

a) receiving body fluid in a collection zone of a skin-piercing element, and

b) removing the skin-piercing element from the body keeping the body fluid sample at the collection zone.

35. Method according to claim 34, wherein the method further comprises determining the presence and/or concentration of an analyte in the body fluid sample.

36. Method according to claim 34, wherein step a) comprises collecting a body fluid sample at the collection zone while the skin-piercing element is introduced in the body.

37. Method according to claim 34, wherein the method comprises pricking skin with said skin-piercing element in advance of step a).

38. System for body fluid analysis comprising

a skin-piercing element having a collection zone for receiving body fluid, wherein at least a portion of said collection zone is open to the environment,

a transport element being spaced from said collection zone so that fluid in said pathway will not contact the transport element,

a fluid receiving means comprising a test zone,

a transport means to bring the transport element into contact with the fluid receiving means, and

a detection unit for receiving signals from said fluid receiving means to determine the presence and/or concentration of an analyte in the body fluid sample.

39. Body fluid sampling device comprising

a skin-piercing element having a collection zone for receiving body fluid, wherein at least a portion of said collection zone is open to the environment and wherein the collection zone comprises 3 or more holes in which the received body fluid is collected

40. Device according to claim 39, wherein the collection zone comprises a porous surface to receive the body fluid.

41. Device according to claim 39, wherein the volume of the body fluid received by the sampling devices is 0.5 μ

l or less.

42. Device according to claim 39, wherein the thickness of the skin-piercing element is below 500 micrometers, preferably below 250 micrometers.

43. System for sample analysis with a device according to claim 39,

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.