Body fluid sampling device

• US 8,000,762 B2
• Filed: 08/31/2006
• Issued: 08/16/2011
• 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: Griss, Patrick, Sarofim, Emad, Jaeggi, Rainer, Zimmer, Volker, Kraemer, Uwe, Calasso, Irio G., Hasker, David
• Primary Examiner(s): Mallari; Patricia C
• Assistant Examiner(s): D'ANGELO, MICHAEL J
• Application Number:
  US11/469,123
• Publication Number:
  US 20060293611A1
• Time in Patent Office: 1,811 Days
• Field of Search: 600325-327, 600/345, 600/347, 600/348, 600/354, 600/573, 600/575, 600/576, 600/577, 600/578, 600583-584
• US Class Current: 600/345
• 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 5/150251 Collection chamber divided into at least two compartments, e.g. for division of samples injection syringes having more than one chamber A61M5/19; syringes for injection of two or more media A61M5/2448, A61M5/284; sample preparation for further analysis A61B5/150755
• CPC Class Codes: A61B 5/150297 for piercing devices, i.e. devices ready to be used for lancing or piercing for piercing elements A61B5/150282, for driving devices A61B5/15029
• 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 5/150419 comprising means for capillary action
• CPC Class Codes: A61B 5/150435 Specific design of proximal end
• 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 5/15107 Piercing being assisted by a triggering mechanism
• CPC Class Codes: A61B 5/15117 comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap

Abstract

Body fluid sampling device comprising a sampling element having a fluid pathway (11) for receiving body fluid, at least a portion of the fluid pathway is open to the environment and further comprising a fluid receiving means (40) being spaced from the fluid pathway so that fluid in the pathway will not contact the fluid receiving means initially. The fluid receiving means has two or more test zones (45) for performing analytical reactions. Fluid from the channel is contacted with the fluid receiving means either by bringing the fluid receiving means and the fluid into mechanical contact or by electrically transporting fluid from the channel onto the fluid receiving means.

Claims

1. A testing device comprising

a sampling element having a fluid pathway for receiving a sample fluid, the fluid pathway having an access region and an end portion, the end portion being downstream from the access region, wherein at least a portion of said fluid pathway is open to the environment and

a fluid receiving means being out of fluidic communication with said fluid pathway so that fluid in said pathway cannot contact the fluid receiving means initially

wherein the fluid receiving means comprises two or more test zones and

wherein the two or more test zones are adapted to contact and fluidically communicate with the access region of the fluid pathway so that a fluid bolus entering the fluid pathway first and residing in the end portion of the fluid pathway is not contacted with the test zones.

2. Device according to claim 1, wherein the sampling element is a skin piercing element.

3. 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 fluid pathway contacts said fluid receiving means.

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

5. Device according to claim 3, wherein said sampling element has a fluid transfer region and at least a portion of said fluid pathway in said fluid transfer region has pointed walls.

6. Device according to claim 5, wherein said fluid receiving means comprises a layer structure that can be depressed or cut by said pointed walls.

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

8. Device according to claim 7, wherein the sampling element has a collection zone in which upstanding elements are located.

9. Device according to claim 1, wherein said sampling element or the fluid receiving means have confining means for confining the area of fluid transfer from the fluid pathway onto the fluid receiving means.

10. Device according to claim 9, wherein said fluid pathway has protruding wall portions and a surface adjacent to the fluid pathway is recessed with respect to the protruding wall portions.

11. Device according to claim 9, wherein a surface adjacent to the fluid pathway is hydrophobic.

12. Device according to claim 1, wherein said fluid receiving means comprises at least one of a reaction zone, a filtration zone and a mixing zone.

13. Device according to claim 1, wherein said sampling element has two or more fluid pathways.

14. Device according to claim 1, wherein said fluid pathway in a first region (a) has a first width and in another region (c) has a second width which is smaller than the first width.

15. Device according to claim 14, wherein said fluid pathway further comprises a collecting zone (b).

16. Device according to claim 1, wherein the two or more test zones are adapted to contact an intermediate section of the fluid pathway so that a fluid bolus entering the fluid pathway first and residing in the end portion of the fluid pathway is not contacted with the test zones.

17. Device according to claim 1, wherein the two or more test zones are adapted to simultaneously contact a fluid in said fluid pathway.

18. Device according to claim 1, wherein the two or more test zones are adapted to contact a fluid in said fluid pathway in a tilted manner.

19. System for body fluid analysis comprising

a sampling element with a fluid pathway for receiving body fluid and a skin piercing tip, the fluid pathway extending from the skin piercing tip to an end portion and including an access region upstream of the end portion, wherein at least a portion of said fluid pathway is open to the environment and

a fluid receiving means being fluidically isolated from said fluid pathway during filling, there being no path for fluid to move between the fluid receiving means and the fluid pathway initially

said fluid receiving means comprising two or more test zones adapted to contact and fluidically communicate with the access region of the fluid pathway and to avoid contact with the fluid first entering the fluid pathway.

20. System according to claim 19, wherein said system comprises a meter with a detection unit for receiving signals from at least one of said test zones to determine the presence and/or concentration of an analyte.

21. System according to claim 20, wherein said meter includes a holder in which said fluid receiving means is received and signal transmission from said at least one test zone to the detector is enabled.

22. System according to claim 20, wherein said meter has a processing unit that receives a signal indicating that the contacting means has contacted the fluid pathway with the fluid receiving means or that sample fluid has reached a test zone.

23. System according to claim 19, comprising a contacting means which contacts a portion of the fluid pathway of the sampling element with the fluid receiving means to provide at least one of said the test zones with sample fluid.

24. System according to claim 23, wherein said contacting means comprises voltage means for applying an electrical potential between said fluid pathway and said fluid receiving means so that fluid from said fluid pathway contacts fluid receiving means.

25. System according to claim 23, wherein said sampling element has a moveable portion and said contacting means applies a force to said moveable portion to move at least a portion of the fluid pathway into contact with the fluid receiving means.

26. System according to claim 19, wherein said sampling element is a skin piercing means and the system further comprising a drive means for driving the skin piercing means into skin to pierce the skin for obtaining a body fluid sample.

27. System according to claim 19, wherein the two or more test zones are adapted to simultaneously contact a fluid in said fluid pathway.

28. System according to claim 19, wherein the two or more test zones are adapted to contact a fluid in said fluid pathway in a tilted manner.

29. Analytical device comprising

a support structure having a channel therein which is accessible from the surrounding in at least an access region, said channel having a fluid introduction region as well as a discharge region located downstream the access region

a fluid receiving means, the fluid receiving means being out of fluidic communication with the channel in a first status and the fluid receiving means being in fluidic communication with the access region of the channel in a second status to receive fluid, so that the fluid receiving means is not contacted with a fluid from the discharge region,

wherein the fluid receiving means comprises two or more test zones.

30. Device according to claim 29, wherein the two or most test zones are adapted to simultaneously contact a fluid located in the access region.

31. Device of claim 29, wherein the two or more test zones are adapted to contact fluid located in the access region in a tilted manner.

32. Analytical device comprising

a support structure having a channel for receiving fluid therein which is accessible from the surrounding in at least an access region,

a fluid receiving means initially being fluidically isolated from the channel and comprising two or more test zones, there being no path for fluid to be initially transported from said channel to said fluid receiving means, and

a source of electrical potential which when turned on applies an electrical potential between fluid in said access region and said fluid receiving means so that fluid from said access region is transported simultaneously onto said two or more test zones.

33. Device according to claim 32, wherein the channel has a discharge region located downstream from the access region, and wherein fluid in the discharge region is not transported onto the two or more test zones.