Device and method for withdrawing body fluid

• US 9,028,426 B2
• Filed: 08/11/2010
• Issued: 05/12/2015
• Est. Priority Date: 02/11/2008
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: List, Hans, Rdel, Wolfgang, Hrauf, Christian
• Primary Examiner(s): EISEMAN, ADAM JARED
• Application Number:
  US12/854,665
• Publication Number:
  US 20110054274A1
• Time in Patent Office: 1,735 Days
• Field of Search: 600/583, 600/584, 606/181, 606/182
• US Class Current: 600/583
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150198 Depth adjustment mechanism at the proximal end of the carrier of the piercing element
• 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 5/150503 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 5/150748 Having means for aiding positioning of the piercing device at a location where the body is to be pierced means for aiding positioning of devices for bringing media into the body A61M5/427, locating blood vessels A61B5/489
• CPC Class Codes: A61B 5/15103 Piercing procedure
• 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 5/15115 Driving means for propelling the piercing element to pierce the skin, e.g. comprising mechanisms based on shape memory alloys, magnetism, solenoids, piezoelectric effect, biased elements, resilient elements, vacuum or compressed fluids
• 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 5/15123 comprising magnets or solenoids
• CPC Class Codes: A61B 5/15128 comprising 2D- or 3D-shaped elements, e.g. cams, curved guide rails or threads comprising tooth-shaped elements A61B5/15132
• CPC Class Codes: A61B 5/1519 comprising driving means, e.g. a spring, for propelling the piercing unit
• CPC Class Codes: A61B 5/15194 fully automatically retracted, i.e. the retraction does not require a deliberate action by the user, e.g. by terminating the contact with the patient's skin

Abstract

The invention relates to a device for removing body fluid with a puncture element that can puncture the skin of a body part. The device includes a housing structure for body fluids obtained from the skin puncture and a puncture drive for a back and forth movement of the puncture element. The duration of withdrawal movement is longer than the duration of the forward movement. The puncture drive is designed to withdraw the puncture element in a first withdrawal phase of the withdrawal movement with a maximum withdrawal speed of more than 0.02 m/s. A second retraction phase follows the first retraction phase. Body fluid is collected during the second retraction phase, which has a duration of between 0.3 and 0.8 seconds and/or a retraction speed of between 0.6 and 2 mm/s.

Claims

1. A device for withdrawing body fluid, comprising:

a lancing element adapted for puncturing the skin of a body part, the lancing element having a lancet tip and a receiving structure for collecting body fluid by capillary action;

a lancing drive for moving the lancing element in forward and return movements;

wherein, the duration of the return movement is longer than the duration of the forward movement, the return movement comprising a first retraction phase during which the lancing drive is configured to move the lancing element at a maximum retraction speed of more than 0.02 m/s, the first retraction phase followed by a second retraction phase for collecting body fluid into the receiving structure, the second retraction phase beginning with a retraction movement of the lancing element and continuing until the lancet tip exits the skin, the lancing drive being configured to move the lancing element during the second retraction phase for a duration of between 0.3 and 0.8 s and/or a retraction speed of between 0.6 and 2 mm/s.

2. The device of claim 1, wherein the lancing element is configured to retract during the first retraction phase a distance of up to 0.5 mm.

3. The device of claim 1, wherein the receiving structure is configured to be filled with body fluid during the second retraction phase while the lancing element still projects into the skin.

4. The device of claim 1, wherein the duration of the forward movement is between 0.3 and 0.7 ms.

5. The device of claim 1, wherein the duration of the first retraction phase is between 0.3 and 3 ms.

6. The device of claim 1, wherein the second retraction phase has a duration of between 0.4 and 0.5 s.

7. The device of claim 1, wherein the mean retraction speed of the lancing element during the second retraction phase is between 1.0 and 1.5 mm/s.

8. The device of claim 1, wherein maximum lancing depth is adjustable between 1 and 2.5 mm.

9. The device of claim 1, further comprising a variable lancing depth, wherein the speed of the lancing element during the return movement is adapted as a function of the variable lancing depth such that the lancing element is configured to remain inserted into the skin for a predetermined dwell period.

10. The device of claim 1, wherein the speed time course during the return movement of the lancing element is presettable independently of the lancing depth.

11. The device of claim 1, wherein the speed of the lancing element in the second retraction phase is essentially constant.

12. The device of claim 1, further comprising a test element for detecting an analyte and to which body fluid can be applied from the receiving structure.

13. The device of claim 12, wherein the total duration of the return movement of the lancing element is less than 2 s.

14. The device of claim 1, wherein the receiving structure comprises a channel configured to be brought into contact with the body fluid during skin puncture.

15. The device of claim 1, wherein the lancing drive has a drive motor and a mechanical drive mechanism, the drive mechanism controlling the forward movement and return movement.

16. The device of claim 15, wherein the drive motor supplies the drive mechanism with mechanical energy for automatic movement control.

17. The device of claim 15, wherein the drive motor is configured to retract the lancing element in the second retraction phase by means of the drive mechanism.

18. The device of claim 15, wherein the drive mechanism comprises a spring-driven cam control.

35. The device of claim 1, wherein the second retraction phase has a retraction speed of between 0.6 and 2 mm/s.

36. The device of claim 1, wherein the duration of the dwell time of the lancet tip during movement of the lancet tip in the second retraction phase is between 0.3 and 0.8 s.

19. A device for withdrawing body fluid, comprising:

a lancing element adapted for puncturing the skin of a body part, the lancing element having a receiving structure for collecting body fluid by capillary action;

a lancing drive for moving the lancing element in forward and return movements;

a test element for detecting an analyte in the body fluid, the lancing drive configured to move the lancing element at a speed during the return movement such that the transfer time for transferring the body fluid from the receiving structure onto the test element is less than 0.5 s, wherein the total duration from the start of the return movement of the lancing element until completion of loading the test element with the body fluid is less than 2 s;

further wherein the return movement comprises a first retraction phase followed by a second retraction phase, the second retraction phase configured for collecting body fluid into the receiving structure, the lancing drive being configured to move the lancing element during the second retraction phase at a retraction speed of between 0.6 and 2 mm/s, wherein the second retraction phase begins with a retraction movement of the lancing element and continues until the lancet tip exits the skin.

20. The device of claim 19, wherein the receiving structure comprises a channel configured to be brought into contact with the body fluid during skin puncture.

21. The device of claim 19, wherein the lancing drive has a drive motor and a mechanical drive mechanism, the drive mechanism configured to control the forward movement and retraction movement during a first retraction phase of the lancing element and the drive motor configured to effect the retraction movement of the lancing element in a second retraction phase.

22. The device of claim 21, wherein the drive motor is configured to supply the drive mechanism with mechanical energy for automatic movement control.

23. The device of claim 21, wherein the drive motor is configured to retract the lancing element in the second retraction phase by means of the drive mechanism.

24. The device of claim 21, wherein the drive mechanism comprises a spring-driven cam control.

40. The device of claim 19, wherein the return movement comprises a first retraction phase followed by a second retraction phase, the second retraction phase configured for collecting body fluid into the receiving structure, the lancing drive being configured to move the lancing element during the second retraction phase at a retraction speed of between 0.6 and 2 mm/s.

25. A method of collecting body fluid with a lancing element having a tip and a receiving structure for collecting blood by capillary action, the method comprising:

inserting the tip of the lancing element into the skin of a body part to a puncture depth;

retracting the tip at a speed of more than 0.02 m/s during a first retraction phase; and

then

retracting the tip during a second retraction phase during which body fluid is collected in the receiving structure, the second retraction phase beginning with a retraction movement of the tip and continuing until the tip exits the skin, the second retraction phase having a duration of between 0.3 and 0.8 s and/or the tip of the lancing element having a retraction speed of between 0.6 and 2 mm/s.

26. The method of claim 25, wherein the first retraction phase comprises retracting the tip of the lancing element a distance of up to 0.5 mm, the distance extending from the deepest puncture position into an intermediate position situated under the skin surface.

27. The method of claim 25, further comprising filling the receiving structure with body fluid during the second retraction phase.

28. The method of claim 25, wherein the step of inserting the lancet tip to a puncture depth has a duration of between 0.3 and 0.7 ms.

29. The method of claim 25, wherein the first retraction phase has a duration of between 0.3 and 3 ms.

30. The method of claim 25, wherein the second retraction phase has a duration of between 0.4 and 0.5 s.

31. The method of claim 25, wherein the lancet tip has an average speed of between 1 and 1.5 mm/s during the second retraction phase.

32. The method of claim 25, wherein the lancet tip has a substantially constant speed during the second retraction phase.

33. The method of claim 25, further comprising transferring the body fluid from the receiving structure onto a test element in less than 0.5 s.

34. The method of claim 33, wherein the total duration from the start of the retracting the tip at a speed of more than 0.02 m/s until completion of loading of the test element with body fluid is less than 2 s.

37. The method of claim 25, wherein the second retraction phase has a retraction speed of between 0.6 and 2 mm/s.

38. The method of claim 25, wherein the duration of the second retraction phase extends until the lancet tip exits the skin.

39. The method of claim 25, wherein the duration of the dwell time of the lancet tip during movement of the lancet tip in the second retraction phase is between 0.3 and 0.8 s.

41. A device for withdrawing body fluid, comprising:

a lancing element adapted for puncturing the skin of a body part, the lancing element having a receiving structure for collecting body fluid by capillary action; and

a lancing drive for moving the lancing element in forward and return movements;

wherein, the duration of the return movement is longer than the duration of the forward movement, the return movement comprising a first retraction phase during which the lancing drive is configured to move the lancing element at a maximum retraction speed of more than 0.02 m/s, the first retraction phase followed by a second retraction phase for collecting body fluid into the receiving structure, wherein the duration of the dwell time of the lancet tip during the retraction movement in the second retraction phase is between 0.3 and 0.8 s and/or the average speed of the lancing element during the retraction movement in the second retraction phase is 0.6 to 2 mm/s.

42. The device of claim 41, wherein the receiving structure is configured to be filled with body fluid during the second retraction phase while the lancing element still projects into the skin.

43. The device of claim 41, wherein the duration of the forward movement is between 0.3 and 0.7 ms.

44. The device of claim 41, wherein the second retraction phase has a duration of between 0.4 and 0.5 s.

45. The device of claim 41, wherein the average retraction speed of the lancing element during the second retraction phase is between 1.0 and 1.5 mm/s.

46. The device of claim 41, further comprising a variable lancing depth, wherein the speed of the lancing element during the return movement is adapted as a function of the variable lancing depth such that the lancing element is configured to remain inserted into the skin for a predetermined dwell period.

47. The device of claim 41, wherein the speed time course during the return movement of the lancing element is presettable independently of the lancing depth.

48. The device of claim 41, wherein the speed of the lancing element in the second retraction phase is essentially constant.