Dual blade lancing test strip

• US 20040106941A1
• Filed: 12/03/2002
• Published: 06/03/2004
• Est. Priority Date: 12/03/2002
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Roe, Steven N., Roe, Jeffrey N.
• Granted Patent: US 7,244,264 B2
• Time in Patent Office: Days
• US Class Current: 606/181
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150213 Venting means
• 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 5/150442 Blade-like piercing elements, e.g. blades, cutters, knives, for cutting the skin
• 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 5/15142 Devices intended for single use, i.e. disposable

Abstract

An integrated lancing test strip includes a pair of blade members that each have a lancing tip that are configured to lance skin. A pair of spacer members connect the blade members together such that the blade members define an internal capillary. A test strip is positioned along the internal capillary, and the test strip is configured to test analyte levels in the bodily fluid. During use, the lancing tips form one or more incisions in the skin. The fluid from the incisions is drawn via capillary action through the internal capillary and onto the test strip.

Claims

1. An integrated lancing test strip device for collecting and analyzing bodily fluid from one or more incisions in skin, comprising:

at least a pair of blade members defining an internal capillary;

the blade members having at least a pair of lancing tips that are configured to lance the one or more incisions in the skin and positioned to draw bodily fluid from the one or more incisions into the internal capillary via capillary action; and

test media positioned along the internal capillary to analyze the bodily fluid.

2. The device of claim 1, wherein the lancing tips are oriented parallel to one another.

3. The device of claim 1, wherein the lancing tips are angled towards one another.

4. The device of claim 3, wherein the lancing tips touch one another.

5. The device of claim 1, further comprising at least a pair of spacer members attached between the blade members.

6. The device of claim 1, further comprising:

a vent block provided at one end of the capillary opposite the lancing tips; and

wherein the test media and the vent block define a vent opening for exhausting gas from the internal capillary.

7. The device of claim 6, wherein said vent block defines a registration opening for aligning the device.

8. The device of claim 1, further comprising wicking material received in the internal capillary.

9. The device of claim 1, wherein the test media includes a reagent test strip.

10. The device of claim 1, wherein the lancing tips have a triangular cross-sectional shape.

11. The device of claim 1, wherein the blade members are flat.

12. The device of claim 11, further comprising:

at least a pair of spacer members attached between the blade members;

a vent block provided at one end of the capillary opposite the lancing tips, said vent block defining a registration opening for aligning the device, wherein the vent block defines a vent opening for exhausting gas from the internal capillary; and

wherein the lancing tips have a triangular cross-sectional shape.

13. The device of claim 12, wherein the lancing tips are oriented parallel to one another.

14. The device of claim 12, wherein the lancing tips are angled towards one another.

15. The device of claim 14, further comprising wicking material received in the internal capillary.

16. An integrated bodily fluid sampling device, comprising:

a first blade member having a first lancing tip configured to lance skin;

a second blade member having a second lancing tip configured to lance the skin;

at least a pair of spacer members attaching the first blade member to the second blade member, the blade members and the spacer members defining a cavity to collect bodily fluid; and

means for testing the bodily fluid positioned along the cavity.

17. The device of claim 16, wherein the means for testing the bodily fluid includes a reagent test strip adapted to indicate analyte levels in the bodily fluid.

18. The device of claim 16, wherein the first and second lancing tips have a generally triangular cross sectional shape.

19. The device of claim 16, wherein the first blade member is flat.

20. The device of claim 19, wherein the second blade member is flat.

21. The device of claim 16, wherein the lancing tips extend parallel to one another.

22. The device of claim 16, wherein the first and second lancing tips angle towards one another.

23. The device of claim 22, wherein the first and second lancing tips contact one another.

24. The device of claim 16, wherein the first and second lancing tips define a capillary gap configured to draw the bodily fluid via capillary action.

25. The device of claim 16, further comprising a vent member enclosing one end of the cavity opposite the first and second lancing tips.

26. The device of claim 25, wherein the means for testing the bodily fluid is positioned along the cavity between the first blade member and the vent member.

27. The device of claim 26, wherein the means for testing the bodily fluid and the vent member define a vent opening for exhausting gas from the cavity.

28. The device of claim 25, wherein the vent member defines a registration opening.

29. The device of claim 16, wherein the cavity includes an internal capillary sized to draw the bodily fluid via capillary action.

30. The device of claim 16, further comprising wicking material received in the cavity.

31. The device of claim 16, wherein the first and second blade members are metallic.

32. The device of claim 16, wherein the spacer members include adhesive beads.

33. A method, comprising:

providing a lancing device that includes at least a pair of blade members that define an internal capillary and a test strip positioned along the internal capillary;

lancing one or more incisions in skin with the blade members; and

drawing bodily fluid from the one or more incisions onto the test strip via capillary action through the internal capillary.

34. The method of claim 33, wherein said drawing the fluid includes touching a drop of the bodily fluid from the one or more incisions in the skin with the blade members.

35. The method of claim 34, wherein said lancing includes removing the blade members from the one or more incisions in the skin before said touching.