Flexible test strip lancet device

• US 20040127929A1
• Filed: 12/16/2003
• Published: 07/01/2004
• Est. Priority Date: 12/30/2002
• 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.
• Granted Patent: US 7,211,052 B2
• Time in Patent Office: Days
• US Class Current: 606/181
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• 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 5/150412 Pointed piercing elements, e.g. needles, lancets for piercing the skin blade-like piercing elements A61B5/150442
• 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 5/15113 Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
• CPC Class Codes: A61B 5/15117 comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
• CPC Class Codes: A61B 5/1519 comprising driving means, e.g. a spring, for propelling the piercing unit

Abstract

A bodily fluid sampling device includes a flexible test strip, a lancet, and a deflection mechanism. The test strip is biased to be positioned over the incision site formed by the lancet. The deflection mechanism positions the test strip away from the incision site during lancing so as to allow the lancet to have clear access to the incision site. Due to the flexible nature of the test strip, after lancing the incision, the test strip returns to the original position so as to collect fluid from the incision.

Claims

1. A method of sampling a body fluid, comprising:

forming an incision in skin with a lancet of a body fluid sampling device that includes a fluid collection means that is resiliently biased away from the incision; and

releasing the fluid collection means in order to resiliently move over the incision site to collect the body fluid from the incision.

2. The method of claim 1, further comprising deflecting the fluid collection means away from the lancet with a deflection mechanism before said forming the incision.

3. The method of claim 2, wherein:

the deflection mechanism includes a cam arm that is coupled to the lancet to move in unison with the lancet; and

said deflecting includes pressing the cam arm against the fluid collection means to bend the fluid collection means.

4. The method of claim 3, wherein said releasing includes retracting the lancet to disengage the cam arm from the fluid collection means.

5. The method of claim 4, further comprising:

wherein the fluid collection means includes a test strip; and

analyzing the body fluid with the test strip.

6. The method of claim 2, wherein:

the fluid collection means is coupled to a deflection arm in the in the body fluid sampling device;

the deflection mechanism includes a trigger to fire the lancet; and

said deflecting includes actuating the trigger to bend the deflection arm.

7. The method of claim 1, wherein said releasing includes disengaging a cam arm in the body fluid sampling device from the fluid collection means.

8. The method of claim 1, wherein:

the body fluid sampling device includes a deflection arm that is coupled to the fluid collection means; and

said releasing includes disengaging a trigger in the body fluid sampling device from the deflection arm.

9. The method of claim 1, further comprising:

wherein the fluid collection means includes a test strip; and

analyzing the body fluid with the test strip.

10. A body fluid sampling device, comprising:

a lancet configured to form an incision in skin;

a sampling mechanism having a sampling end disposed proximal to the lancet that is moveable between a first position over the incision and a second position away from the incision;

a deflection mechanism engageable with the sampling mechanism to deflect the sampling end of the sampling mechanism from the first position to the second position in order to allow the lancet to form the incision; and

wherein at least a portion of the sampling mechanism is resilient in order to return to the first position after the incision is formed.

11. The device of claim 10, wherein the sampling mechanism includes a fluid collection element.

12. The device of claim 11, wherein the fluid collection element includes a test strip.

13. The device of claim 11, wherein the fluid collection element is resilient.

14. The device of claim 11, wherein the sampling mechanism includes a deflection arm that is coupled to the fluid collection element.

15. The device of claim 14, wherein the deflection mechanism includes a trigger configured to fire the lancet.

16. The device of claim 10, wherein the deflection mechanism includes a trigger configured to fire the lancet.

17. The device of claim 10, wherein the deflection mechanism includes a cam arm coupled to the lancet to move in unison with the lancet.

18. The device of claim 17, wherein the cam arm has an angled surface that is engageable with the sampling mechanism to deflect the sampling mechanism.

19. The device of claim 17, wherein the sampling mechanism includes a, fluid collection element.

20. The device of claim 19, further comprising a holder defining a cam arm cavity in which the cam arm is slidably received, the holder defining a fluid collection element cavity in which the fluid collection element is received, wherein the cam arm cavity intersects the fluid collection element cavity.

21. The device of claim 20, wherein:

the holder defines a lancet cavity in which the lancet is slidably received; and

the holder defines a deflection cavity in which the fluid collection element is able to deflect.

22. The device of claim 19, wherein the fluid collection element is angled at an acute angle relative to the lancet to allow the cam arm deflect the fluid collection element before the lancet is able to strike the fluid collection element.

23. The device of claim 10, wherein the sampling end portion of the sampling mechanism is angled at an acute angle relative to the lancet.

24. A body fluid sampling device, comprising:

a lancet for forming an incision at an incision site;

a test strip that is biased over the incision site; and

means for deflecting the test strip from the incision site.

25. The device of claim 24, wherein the means for deflecting the test strip includes a cam arm coupled to the lancet that is configured to deflect the test strip during lancing.

26. The device of claim 24, wherein the means for deflecting the test strip includes a trigger adapted to fire the lancet.

27. A body fluid sampling device, comprising:

means for forming an incision into skin at an incision site;

means for collecting body fluid from the incision; and

a deflection mechanism configured to deflect the means for collecting the body fluid from the incision to allow the means for forming the incision access to the incision site during formation of the incision.

28. The device of claim 27, wherein:

the means for forming the incision includes a lancet; and

the means for collecting the body fluid from the incision includes a test strip.

29. The device of claim 27, wherein the deflection mechanism includes a cam arm.

30. The device of claim 27, wherein the deflection mechanism includes a trigger.