Lancing Element, Lancing System and a Method for Skin Detection

• US 20080294064A1
• Filed: 05/09/2008
• Published: 11/27/2008
• Est. Priority Date: 11/10/2005
• Status: Abandoned Application

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: Calasso, Irio, Korner, Stephan, Wahl, Hans-Peter, Glauser, Michael, Bruendler, Oliver
• Application Number:
  US12/118,146
• Publication Number:
  US 20080294064A1
• Time in Patent Office: Days
• US Class Current: 600/547
• 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 5/150068 by tissue compression, e.g. with specially designed surface of device contacting the skin area to be pierced
• CPC Class Codes: A61B 5/150175 Adjustment of penetration depth
• 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 5/150435 Specific design of proximal end
• 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 5/150954 Means for the detection of operative contact with patient, e.g. by temperature sensitive sensor
• CPC Class Codes: A61B 5/15107 Piercing being assisted by a triggering mechanism
• 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 5/157 Devices characterised by integrated means for measuring characteristics of blood

Abstract

In the case of a disposable lancing element for collecting body fluid through the skin comprising a support and a lancing member which distally projects therefrom and can pierce the skin in a lancing movement, it is proposed that a pretensioning means which tightens the skin in the area of the puncture site is arranged on the support and has a contact member which impacts the skin laterally from the lancing member during the lancing movement.

Claims

1. A lancing element for collecting a body fluid through skin, comprising:

a support;

a lancing member which rigidly projects from the support configured to pierce a skin in a lancing movement; and

,

a pretensioning means coupled to the support which tightens the skin near a puncture site, the pretensioning means having a contact member that impacts the skin during the lancing movement and moves back during the lancing movement in an opposite direction to the lancing member.

2. The lancing element as in claim 1 where the contact member in an initial state is positioned in a direction of lancing to a side and in front of the lancing member or the contact member and the contact member is located at a same level or downstream of the lancing member and is reset against the support during the lancing movement while in contact with the skin.

3. The lancing element as in claim 2 wherein the contact member is supported on the support via a spring element.

4. The lancing element as in claim 2 wherein the contact member is locked in a reset position that is proximally set back relative to the lancing member by means of a locking mechanism.

5. The lancing element as in claim 2 wherein the contact member is moved together with the support when the support is retracted while reducing or removing a contact pressure on the skin.

6. The lancing element as in claim 1 wherein the pretensioning means has a coupling member that is elastically compressible and held by frictional lock that connects the contact member with the support.

7. The lancing element as in claim 1 wherein the coupling member is formed by a folding arm that is bent having at least one bending point.

8. The lancing element as in claim 1 wherein the pretensioning means is attached as an integral component of the support.

9. The lancing element as in claim 1 wherein the support, the lancing member, and the pretensioning means are formed uniformly from one material as a disposable part.

10. The lancing element as in claim 1 wherein the support, the lancing member, and pretensioning means are formed from a flat substrate that is etched and the pretensioning means is arranged as a part of the substrate in a substrate plane or is bent out of the substrate plane.

11. The lancing element as in claim 1 wherein the contact member has a point shaped or linear edge contour configured to be pressed against the skin laterally next to the lancing member.

12. The lancing element as in claim 1 wherein the lancing member is configured to be inserted into the skin at a lateral distance of less than 3 mm from the contact member.

13. The lancing element as in claim 1, further comprising,

a collecting structure that is capillary-active for collecting a body fluid.

14. The lancing element as in claim 1, further comprising,

a stop coupled to the support that limits a lancing depth of the lancing member, the stop having a skin contact surface that impacts at a defined proximal distance from the lancing member during the lancing movement.

15. The lancing element as in claim 14 wherein the stop length that projects from the base member is adjusted to adjust the lancing depth.

16. A lancing system for collecting a body fluid through the skin, comprising:

a support;

a lancing member which rigidly projects from the support configured to pierce skin in a lancing movement;

a pretensioning means coupled to the support which tightens the skin near a puncture site, the pretensioning means having a contact member that impacts the skin during the lancing movement and moves back during the lancing movement in an opposite direction to the lancing member; and

,

a lancing drive for moving the lancing member forwards and backwards to create the lancing movement.

17. The lancing system as in claim 16, further comprising,

a position detector for detecting the position of the skin that has been tightened during the lancing movement of the lancing element.

18. The lancing system as in claim 16 wherein the lancing drive has a device for adjusting a lancing depth of the lancing member relative to a detected reference position of the skin that has been tightened.

19. The lancing system as in claim 16 wherein a distance measuring unit operates incrementally to detect a relative position of the contact member and a lancing member.

20. The lancing system as in claim 17 wherein the skin is supported on a circular receiver and the pretensioning means engages in the receiver.

21. The lancing system as in claim 17 wherein the position detector probes the skin that has been tightened by the pretensioning means using the contact member or the lancing member as a sensor to determine the skin position.

22. The lancing system as in claim 21 wherein the position detector detects a change in capacitance or conductivity or force when it probes the skin.

23. A system for skin detection during taking of body fluid samples, comprising:

a lancing element;

a position detector for detecting the position of a skin relative to a movement axis of the lancing element; and

,

a pretensioning means for locally tightening the skin when the position detector detects the position of the skin relative to a movement axis of the lancing element.

24. The system as in claim 23 wherein the lancing element is moved into a retracted position from the skin after the position detector has detected the position of the skin and before the lancing element moves along the movement axis.

25. The system as in claim according to claim 23 wherein the pretensioning means is formed by a lancing member or a contact member of the lancing element.

26. The system as in claim 23 wherein the lancing element movement is controlled according to the detected position of the skin by a lancing drive in order to set a defined lancing depth.

27. A method for skin detection for taking samples of a body fluid, comprising:

detecting a position of a skin relative to a movement axis of a lancing element; and

,

tightening locally the skin during detecting the position of the skin by a pretensioning means of the lancing element.

28. The method as in claim 27, further comprising,

moving the lancing element into a position that is retracted from the skin after detecting the position of the skin and before a lancing movement.

29. The method as in claim 27 wherein the pretensioning means comprises a lancing member or a contact member of the lancing element.

30. The method as in claim 28 wherein the lancing element is controlled according to a detected skin position in order to set a defined lancing depth.

31. A lancing element with skin pretensioner for lancing depth control while collecting body fluid through skin, comprising:

a support;

a lancing member coupled to the support and configured to rigidly project from the support to pierce skin during a lancing movement; and

,

a pretensioner coupled to the support, the pretensioner having a contact member configured to impact skin during the lancing movement and move in a direction opposite to that of the lancing member during the lancing movement.

32. A lancing element with skin pretensioner for lancing depth control while collecting body fluid through skin, comprising:

a support;

a lancing member coupled to the support and configured to rigidly project from the support to pierce skin during a lancing movement; and

,

means for pretensioning coupled to the support configured to impact skin during the lancing movement and move in a direction opposite to that of the lancing member during the lancing movement.

33. A method for controlling lancing depth during lancing to collect body fluid through a patient'"'"'s skin, comprising:

detecting the position of a skin relative to movement of a lancing element;

tightening skin locally during detecting position of the skin with a pretensioner;

retracting the lancing element from the skin after detecting the position of the skin;

lancing the skin with the lancing element by advancing the lancing element into the skin;

controlling movement of the lancing element according to the position of the skin to set a defined lancing depth; and

,

withdrawing the lancing element by moving the lancing element away from the skin.

34. The method as in claim 33, further comprising,

locking the lancing element at substantially a maximum advance of the lancing element so the pretensioner that has been compressed no longer presses against the skin while withdrawing the lancing element from the skin.