PUNCTURING SYSTEM

• US 20130066356A1
• Filed: 09/14/2012
• Published: 03/14/2013
• Est. Priority Date: 10/08/2005
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: List, Hans, Hoerauf, Christian, Deck, Frank, Weiss, Thomas, Keil, Michael, Schmelzeisen-Redeker, Guenther, Fruhstorfer, Heinrich, Haar, Hans-Peter, Kraemer, Uwe, Hoenes, Joachim, Miltner, Karl
• Granted Patent: US 10,278,631 B2
• Time in Patent Office: Days
• US Class Current: 606/185
• 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 with 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 a test parameter on which a sample-obtaining probability depends. A securing facility is also provided that, in a locked state, locks the triggering means and, in a triggering state, releases the triggering means such that a puncturing motion can be triggered by actuation thereof. 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.

Claims

1. A puncturing device, comprising:

a housing which contains components of the puncturing device;

a puncturing element;

a puncturing element drive adapted to move the puncturing element relative to the housing in a puncturing direction;

a press-on part rigidly connected to the puncturing element drive, the press-on part being configured to be pressed onto a body part in which a puncture wound is to be generated; and

a pressure sensor for determining whether pressure exerted on the press-on part meets or exceeds a defined minimum value, the pressure sensor comprising a spring element against the spring force of which the press-on part is movable relative to the housing opposite the puncturing direction.

2. The puncturing device of claim 1, further comprising a trigger which can be actuated to cause a puncturing motion of the puncturing element after the press-on part is pressed.

3. The puncturing device of claim 2, wherein the trigger becomes actuable when the pressure on the press-on part meets or exceeds the defined minimum value.

4. The puncturing device of claim 2, wherein the trigger is inoperable when the pressure on the press-on part is less than the defined minimum value.

5. The puncturing device of claim 4, wherein the trigger is locked when the pressure on the press-on part is less than the defined minimum value.

6. The puncturing device of claim 1, wherein the puncture element is movable in the puncturing direction only if (i) the pressure on the press-on part meets or exceeds the defined minimum value and (ii) a trigger is subsequently actuated.

7. The puncturing device of claim 1, further comprising a securing facility having a locked state in which the securing facility prevents a puncture from taking place.

8. The puncturing device of claim 7, wherein the securing facility further comprises a triggering state in which a puncture can take place.

9. The puncturing device of claim 8, wherein the securing facility is transitioned from the locked state to the triggering state when the pressure exerted on the press-on part meets or exceeds the defined minimum value.

10. The puncturing device of claim 1, further comprising a visible marker that becomes covered or uncovered when the press-on part is shifted.

11. The puncturing device of claim 1, wherein the device signals the user regarding orientation of the press-on part with respect to the body part.

12. The puncturing device of claim 1, further comprising a signaling facility that produces a signal when the press-on part meets or exceeds the defined minimum value.

13. The puncturing device 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.

14. A puncturing device, comprising:

a housing which contains components of the puncturing device;

a puncturing element;

a puncturing element drive adapted to move the puncturing element relative to the housing in a puncturing direction;

a press-on part connected to the puncturing element drive, the press-on part being configured to be pressed onto a body part in which a puncture wound is to be generated, wherein the press-on part and puncturing element drive move together relative to the housing when the press-on part is pressed onto a body part; and

a pressure sensor for determining whether pressure exerted on the press-on part meets or exceeds a defined minimum value, the pressure sensor comprising a spring element against the spring force of which the press-on part is movable relative to the housing opposite the puncturing direction.

15. The puncturing device of claim 14, wherein the press-on part is rigidly connected to the puncturing element drive.

16. The puncturing device of claim 14, wherein the housing defines a bushing that surrounds the press-on part and puncturing element drive.

17. The puncturing device of claim 14, wherein the puncturing depth of the device is not affected by movement of the press-on part relative to the housing.

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

a housing which contains components of the puncturing system;

a puncturing element movable relative to the housing in a puncturing direction to generate a puncture wound in a body part;

a press-on part configured to be pressed onto the body part and having an opening for the lancet tip to puncture the body part;

a trigger, a manual actuation of which causes the puncturing element to move in the puncturing direction;

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

a securing facility having a locked state 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 the manual actuation, the securing facility being transitioned from the locked state to the triggering state when the at least one test parameter determined by the testing facility meets defined minimum requirements, wherein, the puncturing element is movable in the puncturing direction to generate a puncture wound only if (i) the testing facility determines a test parameter that indicates a successful puncture can be executed and if (ii) the trigger is subsequently actuated.

19. The puncturing system of claim 18, wherein the press-on part is rigidly connected to the puncturing element drive.

20. The puncturing device of claim 18, further comprising 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.

21. The puncturing device of claim 18, wherein the testing facility comprises a sensor configured to determine the blood supply status of a body part touching against the press-on part.

22. The puncturing system of claim 18, 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.

23. The puncturing system of claim 22, wherein the pressure sensor includes 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.

24. The puncturing system of claim 23, further comprising a marker that indicates when the press-on part is in the end position.