PUNCTURING SYSTEM

• US 20080262387A1
• Filed: 03/28/2008
• Published: 10/23/2008
• Est. Priority Date: 10/08/2005
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: List, Hans, Hoenes, Joachim, Weiss, Thomas, Haar, Hans-Peter, Kraemer, Uwe, Hoerauf, Christian, Deck, Frank, Miltner, Karl, Schmelzeisen-Redeker, Guenther, Fruhstorfer, Heinrich, Kistner, Michael
• Granted Patent: US 8,287,467 B2
• Time in Patent Office: Days
• US Class Current: 600/583
• 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 5/150412 Pointed piercing elements, e.g. needles, lancets for piercing the skin blade-like piercing elements A61B5/150442
• 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 5/150824 by visual feedback
• 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 5/15113 Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
• CPC Class Codes: A61B 5/1519 comprising driving means, e.g. a spring, for propelling the piercing unit

Abstract

The invention relates to a puncturing system for generating a puncture wound for obtaining a sample of a body fluid, comprising a press-on part to be pressed onto a body part in which a puncture wound is to be generated, a triggering means, by the actuation of which a user can trigger a puncturing motion of a puncturing element after the press-on part is pressed on, and a testing facility for determining at least one test parameter on which a sample-obtaining probability depends. A securing facility is also provided that, in a locked state, locks the triggering means such that no puncturing motion can be triggered, and, in a triggering state, releases the triggering means such that a puncturing motion can be triggered by actuation thereof, whereby the securing facility is transitioned from the locked state to the triggering state by the testing facility when the test parameter determined by the testing facility meets defined minimum requirements. A signaling facility is also provided for signaling a transition of the securing facility to the triggering state and/or for signaling that the securing facility is in the triggering state. The invention also relates to a method for preparing a puncturing system for generating a puncture wound.

Claims

1. A puncturing system for generating a puncture wound for obtaining a sample of a body fluid, comprising:

a press-on part configured to be pressed onto a body part in which a puncture wound is to be generated;

a trigger, actuation of which causes a puncturing motion of a puncturing element;

a testing facility for determining at least one test parameter on which a sample-obtaining probability depends;

a securing facility having a locked stated and a triggering state, wherein in the locked state the securing facility prevents the trigger from being actuated, and in the triggering state, the securing facility releases the trigger to allow actuation thereof, the securing facility being transitioned from the locked state to the triggering state by the testing facility when the at least one test parameter determined by the testing facility meets defined minimum requirements; and

a signaling facility that signals a transition of the securing facility from the locked state to the triggering state or signals that the securing facility is in the triggering state.

2. The puncturing system of claim 1, wherein the testing facility comprises a sensor configured to determine the blood supply status of a body part touching against the press-on part.

3. The puncturing system of claim 1, wherein the testing facility comprises a pressure sensor configured to determine whether a pressure that exceeds a predetermined minimum pressure bears on the press-on part.

4. The puncturing system of claim 3, wherein the pressure sensor comprises a snap-action element that snaps from a first configuration to a second configuration when a critical minimum pressure is applied thereto.

5. The puncturing system of claim 4, wherein the snap-action element comprises a metal sheet.

6. The puncturing device of claim 3, wherein the pressure sensor comprises a spring element having a spring force against which the press-on part can be shifted with respect to a housing part, further wherein, the press-on-part reaches an end position relative to the housing part when at least the minimum pressure is applied.

7. The puncturing device of claim 6, wherein the press-on part is rigidly connected to a puncturing element drive.

8. The puncturing device of claim 7, further comprising a marker that indicates when the press-on part is in the end position.

9. The puncturing device of claim 8, wherein the marker is disposed on the press-on part.

10. The puncturing system of claim 1, wherein the testing facility generates signals that assist a user in orienting the press-on part with respect to a body part in which a puncture wound is to be generated.

11. The puncturing system of claim 1, wherein the signals comprise visual signals.

12. The puncturing system of claim 1, further comprising a sample reception unit configured to receive a sample of a body fluid during a collection phase after a puncture, wherein the testing facility remains active during the collection phase and displays a warning signal in response to a change of the at least one test parameter that is disadvantageous for sample reception.

13. The puncturing system of claim 12, further comprising a measuring unit for examination of a body fluid sample for a medically significant analyte, the testing facility being connected to the measuring unit, wherein an analysis of the sample thus obtained is prevented if a critical change of the at least one test parameter occurs during the collection phase.

14. A method of using a puncturing device for generating a puncture wound to obtain a body fluid sample, comprising:

pressing a press-on part of the puncturing system against a body part to be punctured;

determining at least one test parameter on which a sample-obtaining probability depends;

when the test parameter meets a defined minimum requirement, unlocking a trigger of the puncturing device;

providing a signal that that the trigger is unlocked; and

actuating the trigger, thereby causing a puncturing motion of a puncturing element.

15. The method of claim 14, wherein the determining step comprises determining pressure exerted on the body part by the press-on part.

16. The method of claim 14, further comprising moving the press-on part relative to a housing of the device.

17. The method of claim 16, further comprising resisting the movement of the press-on part using a spring.

18. The method of claim 14, wherein the step of providing the signal comprises providing a visual signal.

19. The method of claim 14, wherein the step of providing a signal comprises covering or uncovering a marker.

20. The method of claim 14, further comprising collecting a body fluid sample while monitoring the at least one test parameter and providing a warning signal when the monitored value of the at least one test parameter reaches an unfavorable state.

21. A method of using a puncturing device for generating a puncture wound to obtain a body fluid sample, comprising:

pressing a press-on part of the puncturing system against a body part to be punctured;

measuring the pressure exerted on the body part by the press-on part;

when the measured pressure meets or exceeds a defined minimum value, unlocking a trigger of the puncturing device;

providing a signal that that the trigger is unlocked; and

manually actuating the trigger, thereby causing a puncturing motion of a puncturing element.

22. The method of claim 21, further comprising moving the press-on part relative to a housing of the device.

23. The method of claim 22, further comprising resisting the movement of the press-on part using a spring.

24. The method of claim 21, wherein the step of providing the signal comprises providing a visual signal.

25. The method of claim 21, wherein the step of providing a signal comprises covering or uncovering a marker.

26. A puncturing device, comprising:

a housing;

a puncturing element;

a press-on part movable relative to the housing and configured to be pressed onto a body part in which a puncture wound is to be generated;

a trigger, actuation of which causes a puncturing motion of the puncturing element;

a pressure sensor for determining whether pressure exerted on the press-on part meets or exceeds a defined minimum value;

a securing facility having a locked stated and a triggering state, wherein in the locked state the securing facility prevents the trigger from being actuated, and in the triggering state, the securing facility releases the trigger to allow actuation thereof, the securing facility being transitioned from the locked state to the triggering state when the pressure sensor determines that the pressure exerted on the press-on part meets or exceeds the defined minimum value; and

a signaling facility that signals a transition of the securing facility from the locked state to the triggering state or signals that the securing facility is in the triggering state.

27. The puncturing system of claim 26, wherein the pressure sensor comprises a snap-action element that snaps from a first configuration to a second configuration when a critical minimum pressure is applied thereto.

28. The puncturing system of claim 27, wherein the snap-action element comprises a metal sheet.

29. The puncturing device of claim 26, wherein the pressure sensor comprises a spring element having a spring force against which the press-on part can be shifted relative to a housing of the device, further wherein the press-on-part reaches an end position with respect to the housing when the pressure meets or exceed the minimum value.

30. The puncturing device of claim 29, further comprising a marker that indicates when the press-on part is in the end position.

31. The puncturing device of claim 30, wherein the marker is disposed on the press-on part.

32. The puncturing system of claim 26, further comprising a sample reception unit that is used to receive a sample of a body fluid during a collection phase after a puncture, wherein the testing facility remains active until the end of the collection phase and displays a warning signal in response to a change of the at least one test parameter that is disadvantageous for sample reception.

33. The puncturing system of claim 26, further comprising a measuring unit for examination of a body fluid sample for a medically significant analyte, the pressure sensor communicating with the measuring unit, wherein an analysis of the sample thus obtained is prevented if a critical change of the measured pressure occurs during the collection phase.