Device and method for obtaining body fluid

• US 8,608,667 B2
• Filed: 07/16/2008
• Issued: 12/17/2013
• Est. Priority Date: 07/17/2007
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Hoerauf, Christian, List, Hans, Zimmer, Volker
• Primary Examiner(s): Hindenburg, Max
• Assistant Examiner(s): Foreman, Jonathan M
• Application Number:
  US12/174,346
• Publication Number:
  US 20090024059A1
• Time in Patent Office: 1,980 Days
• Field of Search: 600/583, 600/584, 606/181, 606/182
• US Class Current: 600/583
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• 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 5/150358 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 5/15117 comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
• 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

A device is disclosed for obtaining body fluid, in particular blood, comprising a lancing element having a tip for puncturing the skin of a body part and an actuator coupled with the lancing element for a forward and backward movement of the lancing element, where the lancing element can be inserted into the skin up to an optionally adjustable puncture position. The actuator is adapted to drive the lancing element forwardly to a penetration speed of at most 0.7 m/s when the lancing element penetrates the skin.

Claims

1. A device for obtaining a body fluid, the device comprising:

a lancing element having a tip for puncturing skin of a body part;

a test field fluidically connected to the lancing element; and

an actuator coupled to the lancing element for moving the lancing element forwardly to penetrate the skin and backwardly to retract from the skin, wherein the actuator drives the lancing element forwardly at a penetration speed less than 0.7 m/s and backwardly at an average retraction speed between 0.001 and 0.01 m/s, and wherein the penetration speed is less than 100 times the average retraction speed, wherein the actuator drives the tip of the lancing element forwardly to a deepest puncture position between 1 and 2 mm below the surface of the skin, and the actuator retracts the tip of the lancing element from the deepest puncture position to the surface of the skin during a retraction period of between 200 ms and 800 ms.

2. The device of claim 1 wherein the penetration speed is 0.4 to 0.5 m/s.

3. The device of claim 1 wherein the actuator accelerates the lancing element until it penetrates the skin.

4. The device of claim 1 wherein the actuator retracts the tip of the lancing element from the deepest puncture position to the surface of the skin during a retraction period of between 250 ms and 750 ms.

5. The device of claim 1 wherein the actuator drives the tip of the lancing element forwardly to the deepest puncture position about 1.2 mm below the surface of the skin.

6. The device of claim 1 wherein the lancing element comprises a collecting structure for taking up the body fluid.

7. The device of claim 6 wherein the collecting structure comprises a capillary.

8. The device of claim 1 further comprising a positioning device that positions the body part in a lancing area of the lancing element.

9. The device of claim 1, further comprising a measuring device that detects a substance contained in the body fluid obtained with the lancing element.

10. The device of claim 1 wherein the actuator comprises a spring-driven sliding gate drive that controls the movements of the lancing element.

11. The device of claim 1 wherein at least one of the actuator and the lancing element interact with at least one of a stop or a damping device to limit movement of the lancing element.

12. The device of claim 1 further comprising a linear guide which guides at least part of the lancing element in a straight line.

13. The device of claim 1 wherein the lancing element is formed from a round wire having a diameter of less than 0.5 mm.

14. The device of claim 1 wherein the lancing element is formed from a flat material having a thickness of less than 0.2 mm.

15. A method for obtaining body fluid, comprising:

a) providing a lancing element comprising a tip for puncturing skin of a body part and an actuator coupled with the lancing element;

b) actuating the actuator for moving the lancing element;

c) moving the lancing element forwardly at a penetration speed of less than 0.7 m/s to penetrate the skin to a deepest puncture position between 1 and 2 mm below the surface of the skin; and

d) moving the lancing element backwardly to retract from the skin at an average retraction speed between 0.001 and 0.01 m/s and wherein the penetration speed is less than 100 times the average retraction speed, and the actuator retracts the tip of the lancing element from the deepest puncture position to the surface of the skin during a retraction period of between 200 ms and 800 ms.

16. The method of claim 15 wherein the actuator is used to move the lancing element forwardly and backwardly.

17. The method of claim 15 wherein the penetration speed is between 0.4 and 0.5 m/s.

18. The method of claim 17 wherein the actuator is used to move the lancing element forwardly and backwardly.

19. A device for obtaining a body fluid, the device comprising:

a lancing element having a tip for puncturing skin of a body part;

a test field fluidically connected to the lancing element; and

an actuator coupled to the lancing element for moving the lancing element forwardly to penetrate the skin and backwardly to retract from the skin, wherein the actuator drives the lancing element forwardly at a penetration speed less than 0.7 m/s and backwardly at an average retraction speed between 3 and 9 mm/s, wherein the penetration speed is less than 100 times the average retraction speed.