Puncturing system for collecting body fluid sample

• US 7,811,236 B2
• Filed: 05/19/2008
• Issued: 10/12/2010
• Est. Priority Date: 12/15/2005
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Eusemann, Michael, List, Hans, Haar, Hans-Peter, Meacham, George Bevan Kirby
• Primary Examiner(s): Hindenburg; Max
• Assistant Examiner(s): Lloyd; Emily M
• Application Number:
  US12/122,908
• Publication Number:
  US 20080262388A1
• Time in Patent Office: 876 Days
• Field of Search: 600/583, 600/573, 600/576, 600/584, 606/181, 606/182
• US Class Current: 600/583
• CPC Class Codes: A61B 5/14514 using means for aiding extraction of interstitial fluid, e.g. microneedles or suction
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150152 by an adequate mechanical impact on the puncturing location
• CPC Class Codes: A61B 5/150175 Adjustment of penetration depth
• CPC Class Codes: A61B 5/15019 Depth adjustment mechanism using movable stops located inside the piercing device housing and limiting the travel of the drive mechanism mechanisms using distal end caps A61B5/150183, mechanisms at the piercing element carrier proximal end A61B5/150198
• CPC Class Codes: A61B 5/150419 comprising means for capillary action
• CPC Class Codes: A61B 5/150519 Details of construction of hub, i.e. element used to attach the single-ended needle to a piercing device or sampling device
• 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 5/15119 comprising shape memory alloys
• 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
• CPC Class Codes: A61B 5/15196 semi-automatically retracted, i.e. in which the retraction of the piercing unit requires a deliberate action by the user such as manual release of spring-biased retraction means

Abstract

A microsampler puncturing system for collecting a body fluid from a body part is described, comprising a sample collection unit having a piercing element, and a puncturing instrument having a drive, by which a sample collection unit is movable on a movement path for piercing the piercing element into the skin of the body part and withdrawing it in a piercing and retraction movement, a setting device for setting the puncturing depth of the piercing wound to be generated, and a control device for controlling the piercing and retraction movement having the following sequentially executed movement phases: a forward phase, a retraction phase, and a collecting phase (S). The setting device is settable independently of the chronological mean <dr> of the defined residual puncturing depth (dr), with reference to the collecting phase.

Claims

1. A microsampler puncturing system for collecting a body fluid sample from a body part, comprising:

a sample collection unit having a piercing element, and

a puncturing instrument having;

a drive, wherein the sample collection unit is movable on a movement path in a piercing and retraction movement for piercing the piercing element into skin of the body part, creating a piercing wound and withdrawing the piercing element thereafter,

a setting device configured to set a defined puncturing depth of the piercing wound, and

a control device configured to control the piercing and retraction movement, the piercing and retraction movement including the following sequentially executed movement phases;

a forward phase, in which the piercing element is moved in a puncturing direction and pierced to the defined puncturing depth,

a retraction phase, in which the piercing element is partially withdrawn by a retraction distance and is decelerated toward an end of the retraction phase, in such a manner that the piercing element projects into the skin to a residual puncturing depth, and

a collecting phase, in which a body fluid sample is withdrawn by the sample collection unit, via the piercing element projecting into the skin and being stationary, such that the residual puncturing depth is constant, or moving opposite to the puncturing direction,

wherein a mean value of the residual puncturing depth corresponds to the time integral of the residual puncturing depth from the beginning of the collecting phase to the end of the collecting phase divided by the duration of the collecting phase,

the setting device is adapted to set the defined puncturing depth independently of the mean value of the residual puncturing depth and

the setting device is adapted to set the mean value of the residual puncturing depth independently of the defined puncturing depth.

2. The puncturing system according claim 1, wherein the control device is adapted to control, as a further movement phase, a further retraction phase, in which the piercing element is accelerated again and withdrawn completely from the skin.

3. The puncturing system according to claim 1, wherein the puncturing instrument comprises a retraction stop, wherein the piercing element is stopped at the residual puncturing depth at the end of the retraction phase.

4. The puncturing system according to claim 3, wherein the retraction stop comprises a spring element, wherein an abutting element of the retraction stop is moved into a blockade position to stop the piercing element.

5. The puncturing system according to claim 1, further comprising a reference element which is adapted for contacting the skin surface to ensure a reproducible defined puncturing depth during piercing, the reference element being movable in relation to the piercing element and in relation to a device housing.

6. The puncturing system according to claim 5, wherein the piercing element is moved together with the reference element in the puncturing direction during at least a part of the forward phase, and the reference element is moved backward opposite to the puncturing direction during at least a part of the retraction phase.

7. The puncturing system according to claim 6, wherein the reference element is moved forward simultaneously with the piercing element toward the end of the forward phase by at most 5 mm.

8. The puncturing system according to claim 7, wherein the reference element rests in a rest position during a part of the forward phase and is accelerated toward the end of the forward phase in the puncturing direction starting from the rest position.

9. The puncturing system according to claim 6, wherein the part of the forward phase during which the reference element is moved together with the piercing element is at most 100 ms in duration.

10. The puncturing system according claim 5, further comprising a drive spring that is, during at least one part of the forward phase, coupled to the piercing element;

the reference element being, during at least a part of the one part of the forward phase, coupled via a co-transport device to the piercing element and thus to the drive spring;

the co-transport device comprising a first puncturing depth delimiting stop coupled to the piercing element and a second puncturing depth delimiting stop coupled to the reference element; and

the puncturing depth delimiting stops abut against one another in such a manner that their relative distance in a longitudinal direction at a reversal point of the piercing movement defines a longitudinal position of the piercing element in relation to the reference element, thereby defining the defined puncturing depth.

11. The puncturing system according to claim 10, wherein the reference element is coupled via a bidirectionally acting co-transport device to the piercing element and the drive spring, the co-transport device comprising stops coupled to the piercing element and to the reference element, wherein the stops abutting against one another during at least a part of the retraction phase in such a manner that the position of the piercing element in relation to the reference element is thereby defined.

12. The puncturing system according to claim 1, wherein the retraction phase between the end of the forward phase and the start of the collecting phase is at most 2 seconds in duration.

13. The puncturing system according to claim 1, wherein the drive is a spring drive.

14. The puncturing system according to claim 13, wherein the spring drive has a drive rotor driven by a drive spring.

15. The puncturing system according to claim 1, wherein the control device comprises a curve controller having a control curve and a control curve traveler for traveling along the control curve.

16. The puncturing system according to claim 15, wherein the control curve comprises an active section along which the control curve traveler travels during the forward phase and the retraction phase, the active section having at least one boundary that is adjustable for setting at least one of the defined puncturing depth and the residual puncturing depth.

17. The puncturing system according to claim 16, wherein, with reference to the movement of the control curve traveler, an end of the active section of the control curve is adjustable for setting the residual puncturing depth.

18. The puncturing system according to claim 16, wherein, with reference to the movement of the control curve traveler, a start of the active section of the control curve is adjustable for setting the defined puncturing depth.

19. The puncturing system according to claim 15, wherein the control device comprises a second control curve and a second control curve traveler for traveling along the second control curve.

20. The puncturing system according to claim 19, wherein the control curve is provided on a first part of a drive rotor of the drive and the second control curve is provided on a second part of the drive rotor, a distance between the first part of the drive rotor and the second part of the drive rotor in the puncturing direction being adjustable by a setting device.

21. The puncturing system according to claim 19, wherein at least one of the control curve travelers is not guided during a part of the piercing and retraction movement by the respective control curve(s) of the at least one control curve traveler, the part of the piercing and retraction movement being adjustable by a setting device.

22. The puncturing system according to claim 1, wherein the control device comprises a pivot unit which is pivotable from a starting position into a final position, thereby causing the piercing and retraction movement of the piercing element, the final position being defined by an end stop which is adjustable to set the residual puncturing depth.

23. The puncturing system according to claim 22, wherein the pivot unit includes a parallelogram guide.

24. The puncturing system according to claim 22, wherein the pivot unit includes a toggle lever.

25. The puncturing system according to claim 22, wherein the starting position is defined by an adjustable starting stop.