Puncturing system

• US 10,278,631 B2
• Filed: 09/14/2012
• Issued: 05/07/2019
• 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
• Primary Examiner(s): Kremer, Matthew
• Application Number:
  US13/619,459
• Publication Number:
  US 20130066356A1
• Time in Patent Office: 2,426 Days
• Field of Search: None
• 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

Disclosed is 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 trigger, 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 trigger such that no puncturing motion can be triggered, and, in a triggering state, releases the trigger 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. Also disclosed is a method for preparing a puncturing system for generating a puncture wound.

Claims

1. A puncturing device, comprising:

a housing;

a puncture element;

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

a press-on part configured to be pressed onto a body part in which a puncture wound is to be generated and having an opening through which the puncture element extends to create the puncture wound during a puncture movement, the press-on part being rigidly connected and fixed to the puncture element drive, wherein the press-on part and the puncture element drive move together as a unit relative to the housing when the press-on part is pressed onto the body part, whereby puncturing depth of the puncture element relative to the press-on part is not affected by movement of the press-on part relative to the housing; 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 a 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 manually actuated to cause the puncture movement 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 manually actuated.

7. The puncturing device of claim 1, further comprising a lock facility having a locked state in which the lock facility prevents the puncture element from moving in the puncturing direction.

8. The puncturing device of claim 7, wherein the lock facility further comprises a triggering state in which a puncture can take place in which the puncture element drive can be actuated.

9. The puncturing device of claim 8, wherein the lock 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 moved relative to the housing.

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 signal generator 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 receptor configured to receive a sample of a body fluid during a collection phase after a puncture.

14. The puncturing device of claim 1, wherein the housing defines a bushing that surrounds the press-on part and the puncture element drive.

15. A puncturing device, comprising:

a housing;

a puncture element;

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

a one-piece press-on part configured to be pressed onto a body part in which a puncture wound is to be generated and having an opening through which the puncture element extends to create the puncture wound during a puncture movement, the press-on part being rigidly connected and fixed to the puncture element drive, wherein the press-on part and the puncture element drive move together as a unit relative to the housing when the press-on part is pressed onto the body part, whereby puncturing depth of the puncture element relative to the press-on part is not affected by movement of the press-on part relative to the housing; 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 a spring force of which the press-on part is movable relative to the housing opposite the puncturing direction.

16. A puncturing device, comprising:

a housing;

a puncture element;

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

a press-on part configured to be pressed onto a body part in which a puncture wound is to be generated and having an opening through which the puncture element extends to create the puncture wound during a puncture movement, the press-on part being rigidly connected to the puncture element drive, wherein the press-on part and the puncture element drive move together as a unit relative to the housing when the press-on part is pressed onto the body part, whereby puncturing depth of the puncture element relative to the press-on part is not affected by movement of the press-on part relative to the housing; 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 a spring force of which the press-on part is movable relative to the housing opposite the puncturing direction; and

a trigger which can be manually actuated to cause the puncture movement after the press-on part is pressed, the trigger being separately actuable by a user from the movement of the press-on part.