BODY FLUID SAMPLING DEVICE

• US 20060293611A1
• Filed: 08/31/2006
• Published: 12/28/2006
• 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, Griss, Patrick, Sarofim, Emad, Hasker, Dave, Jaeggi, Rainer, Zimmer, Volker, Kraemer, Uwe
• Granted Patent: US 8,000,762 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 5/150251 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, wherein at least a portion of said fluid pathway is open to the environment and

a fluid receiving means being out of fluidic contact from said fluid pathway so that fluid in said pathway will not contact the fluid receiving means initially wherein the fluid receiving means comprises two or more 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 (26) in which upstanding elements (26′

) 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 said contacting area of the two or more test zones and the capillary channel is located in an intermediate portion of the capillary channel so that a fluid bolus entering the capillary first is not contacted with the test zones.

17. System for body fluid analysis comprising

a sampling element with a fluid pathway for receiving body fluid, wherein at least a portion of said fluid pathway is open to the environment and

a fluid receiving means being out of fluidic contact from said fluid pathway during filling so that fluid in said pathway will not contact the fluid receiving means initially

said fluid receiving means comprising two or more test zones.

18. System according to claim 17, 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.

19. System according to claim 18, 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.

20. System according to claim 17, 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.

21. System according to claim 18, 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.

22. System according to claim 20, 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.

23. System according to claim 20, 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.

24. System according to claim 17, 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.

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

a) receiving body fluid in a fluid pathway of a sampling element,

b) contacting the sampling element with a fluid receiving means comprising two or more test zones so that body fluid from a fluid pathway of the sampling element contacts the fluid receiving means and reaches at least one of said test zones,

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

d) processing said signals to determine an analyte concentration.

26. Method according to claim 25, wherein a time period beginning with step b) is monitored and determination of analyte concentration is initiated based on the time passed.

27. Method according to claim 25, wherein step b) initiates a monitoring of signals and the change of signal over time is employed to determine a point in time for concentration determination.

28. Method according to claim 25 comprising pricking skin with said skin piercing element.

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 spaced from the channel in a first status and the fluid receiving means being in contact with fluid located in the access region 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. 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 being spaced from the channel

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 onto said fluid receiving means,

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

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

a) receiving body fluid in a fluid pathway of a sampling element,

b) contacting the sampling element with a first fluid receiving means comprising at least one test zone so that body fluid from a fluid pathway of the sampling element contacts the first fluid receiving means and reaches its at least one test zone,

c) simultaneously or subsequently contacting the sampling element with a second fluid receiving means comprising at least one test zone so that body fluid from the fluid pathway of the sampling element contacts the second fluid receiving means and reaches its at least one test zone,

d) receiving signals from the at least one test zone of the first and second fluid receiving means,

e) processing said signals to determine analyte concentrations.