PUNCTURING DEVICE

• US 20080064986A1
• Filed: 08/25/2007
• Published: 03/13/2008
• Est. Priority Date: 08/25/2006
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: List, Hans, Kraemer, Uwe
• Granted Patent: US 7,766,847 B2
• Time in Patent Office: Days
• US Class Current: 600/583
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• 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 5/150809 by audible feedback
• CPC Class Codes: A61B 5/150816 by tactile feedback, e.g. vibration
• CPC Class Codes: A61B 5/150824 by visual feedback
• CPC Class Codes: A61B 5/15111 Semi-automatically triggered, e.g. at the end of the cocking procedure, for instance by biasing the main drive spring or when reaching sufficient contact pressure, the piercing device is automatically triggered without any deliberate action by the user
• 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 5/1519 comprising driving means, e.g. a spring, for propelling the piercing unit

Abstract

A puncturing device for generating a puncture wound to sample a body fluid is provided and comprises a press-on part or contact element to be pressed against a body part to generate a puncture, a test sensor for measuring a test parameter value, and an analytical unit for determining whether the value of the measured test parameter satisfies a predefined minimum requirement for successful sampling. In one embodiment, the value of the test parameter is monitored during a waiting period by the test sensor once the value satisfies the predefined minimum requirement. After the waiting period has elapsed, so long as the values of the test parameter monitored during the waiting period are in a range of values that predicts sampling to be successful, the analytical unit initiates a puncture.

Claims

1. A puncturing device for generating a puncture in a body part for sampling a body fluid, comprising:

a housing having a contact element adapted to be pressed against a body part;

a sensor for detecting a test parameter; and

an analytical unit disposed in the housing and in communication with the sensor, the analytical unit determining whether the detected test parameter meets a test condition and initiating a waiting period that begins when the test parameter meets the test condition, the analytical unit determining whether to trigger the puncturing operation at the end of the waiting period.

2. The puncturing device of claim 1, wherein the sensor monitors the test parameter during the waiting period and the analytical unit determines whether the test parameter falls within a predefined range during the waiting period, wherein the analytical unit initiates the puncturing operation at the end of the waiting period if the test parameter falls within the predefined range during the waiting period.

3. The puncturing device of claim 1, further comprising a spring that compresses when the contact element presses against the body part, wherein the contact element moves relative to the housing.

4. The puncturing device of claim 3, wherein the sensor comprises a pressure sensor that detects pressure exerted on the contact element.

5. The puncturing device of claim 1, wherein the waiting period is at least 0.5 seconds.

6. The puncturing device of claim 1, further comprising an operating element that allows a user to adjust the waiting period.

7. The puncturing device of claim 6, wherein the operating element is configured to allow a user to set the test condition.

8. The puncturing device of claim 1, further comprising a signaling unit that indicates time remaining in the waiting period.

9. The puncturing device of claim 1, further comprising a display that displays whether the test parameter meets the test condition.

10. The puncturing device of claim 1, further comprising a measuring unit disposed in the housing and configured to test a body fluid sample.

11. The puncturing device of claim 1, further comprising a manually actuated element to trigger a puncture.

12. The puncturing device of claim 1, wherein the sensor monitors the test parameter during the waiting period and the analytical unit determines whether the test parameter meets a second test condition during the waiting period, wherein the analytical unit initiates the puncturing operation at the end of the waiting period if the second test condition is met during the waiting period.

13. The puncturing device of claim 12, wherein the test sensor comprises a pressure sensor and the test parameter comprises pressure exerted on the contact element, further wherein the test condition comprises a first pressure and the second test condition comprises a second pressure that is less than the first pressure.

14. A method for puncturing a body part to withdraw a body fluid sample, comprising:

pressing a contact element of a puncturing device against a body part while measuring a test parameter with a sensor of the puncturing device;

determining whether the test parameter meets a test condition;

beginning a waiting period if the test parameter meets the test condition; and

determining whether to puncture the body part at the end of the waiting period.

15. The method of claim 14, wherein the sensor continues to measure the test parameter during the waiting period.

16. The method of claim 14, wherein the sensor measures pressure applied by the contact element against the body part.

17. The method of claim 14, further comprising detecting the test parameter during the waiting period and determining whether the test parameter meets a second test condition.

18. The method of claim 17, further comprising restarting the waiting period if the test parameter fails to meet the second test condition.

19. The method of claim 17, further comprising puncturing the body part at the end of the waiting period if the test parameter meets the second test condition.

20. The method of claim 14, further comprising closing a switch when the test parameter meets the test condition.

21. The method of claim 14, wherein the pressing step further comprises compressing a spring that is connected to the contact element and measuring force thereby applied to the spring.

22. The method of claim 14, wherein the waiting period is at least 0.5 seconds.

23. The method of claim 14, further comprising displaying the time remaining in the waiting period.

24. The method of claim 14, further comprising displaying whether the test parameter satisfies the test condition.

25. The method of claim 14, further comprising manually actuating an initiation element to trigger a puncture.