Puncturing System For Collecting Body Fluid Sample

• US 20080262388A1
• Filed: 05/19/2008
• Published: 10/23/2008
• 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: List, Hans, Haar, Hans-Peter, Meacham, George Bevan Kirby, Eusemann, Michael
• Granted Patent: US 7,811,236 B2
• Time in Patent Office: Days
• 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

The invention relates to a microsampler puncturing system for collecting a body fluid from a body part, 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 withdraw it again by means of 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 (V), in which the piercing element is pierced up to a defined puncturing depth (dm), a retraction phase (R1), in which the piercing element is partially retracted by a retraction distance (Δd) and is decelerated toward the end of the retraction phase (R1), so that it remains projecting into the skin at a defined residual puncturing depth (dr), and a collecting phase (S), in which the piercing element projects into the skin and a body fluid sample is absorbed by the sample collection unit. The setting device is adapted for the defined puncturing depth 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, andstanl

a puncturing instrument having

a drive by which 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 for setting a defined puncturing depth of the piercing wound, and

a control device for controlling 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,

retraction phase, in which the piercing element is partially withdrawn by a retraction distance and is decelerated toward an end of the retraction phase, so that the piercing element projects into the skin to a defined residual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

a collecting phase, in which the piercing element projects into the skin at the defined residual puncturing depth and a body fluid sample is withdrawn by the sample collection unit,

wherein

the setting device is adapted for setting the defined puncturing depth independently of a mean value of the defined residual puncturing depth, with reference to the collecting phase.

2. The puncturing system according to claim 1, wherein the setting device is adapted for setting the mean value of the defined residual puncturing depth independently of the defined puncturing depth.

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

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

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

6. The puncturing system according to claim 1, further comprising a reference element which is adapted for contacting the skin surface, thereby 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.

7. The puncturing system according to claim 6, 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.

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

9. The puncturing system according to claim 8, 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.

10. The puncturing system according to claim 7, 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.

11. 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 most 2 seconds in duration.

12. The puncturing system according claim 6, further comprising a drive spring which 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, the puncturing depth delimiting stops abutting 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.

13. The puncturing system according to claim 11, 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 acting in the retraction phase and coupled to the piercing element and to the reference element, respectively, 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.

14. The puncturing system according to claim 1, wherein a position of the skin is detected before triggering the piercing movement and the piercing movement is adapted to the detected skin position.

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

16. The puncturing system according to claim 15, wherein the spring drive has a drive rotor driven by a drive spring.

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

18. The puncturing system according to claim 17, wherein the control curve comprises an active section along which the control curve traveller 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 defined residual puncturing depth.

19. The puncturing system according to claim 18, wherein, with reference to the movement of the control curve traveller, an end of the active section of the control curve is adjustable for setting the defined residual puncturing depth.

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

21. The puncturing system according to claim 17, wherein the control device comprises a second control curve and a second control curve traveller for traveling along the second control curve.

22. The puncturing system according to claim 21, 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.

23. The puncturing system according to claim 21 wherein at least one of the control curve travellers is not guided during a part of the piercing and retraction movement by its respective control curve the part of the piercing and retraction movement being adjustable by a setting device.

24. 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 predefined by an end stop which is adjustable to set the defined residual puncturing depth.

25. The puncturing system according to claim 24, wherein the pivot unit includes a parallelogram guide.

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

27. The puncturing system according to claim 24, wherein the starting position is defined by an adjustable starting stop.

28. A puncturing instrument, comprising

a sample collection unit,

a lancet holder for holding the sample collection unit,

a drive for driving the lancet holder through a piercing and retraction movement,

and

a damping mechanism coupled to the lancet holder to damp deceleration of the lancet holder toward an end of the retraction movement.

29. The puncturing instrument according to claim 28, wherein the damping mechanism comprises a rotational damper.

30. The puncturing instrument according to claim 29, wherein the rotational damper comprises a chamber, in which a rotating body is mounted so it is rotatable in a damping liquid.

31. A puncturing instrument for collecting a fluid sample, comprising

a sample collection unit having a piercing element,

a control device for controlling movement of the sample collection unit through a plurality of movement phases including

a forward phase wherein the piercing element pierces skin of a body and moves to a puncturing depth,

a retraction phase wherein the piercing element retracts from the puncturing depth to a residual depth, and

a collection phase wherein the sample collection unit collects the fluid sample while the piercing element is substantially at the residual depth, and

a setting device configured to set the puncturing depth independently of the residual depth.