Puncturing device

• US 7,766,847 B2
• Filed: 08/25/2007
• Issued: 08/03/2010
• Est. Priority Date: 08/25/2006
• Status: Expired due to Fees

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: List, Hans, Kraemer, Uwe
• Primary Examiner(s): Hindenburg; Max
• Assistant Examiner(s): DOUGHERTY, SEAN PATRICK
• Application Number:
  US11/845,051
• Publication Number:
  US 20080064986A1
• Time in Patent Office: 1,074 Days
• Field of Search: 600583-584, 600/573, 606181-185
• US Class Current: 600/584
• 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;

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; and

a signaling unit that generates a user-recognizable optical, acoustic or vibratory signal indicating elapsed time of the waiting period;

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, further 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.

2. 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.

3. The puncturing device of claim 2, wherein the sensor comprises a pressure sensor that detects pressure exerted on the contact element.

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

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

6. The puncturing device of claim 5, wherein the operating element is configured to allow a user to set the test condition.

7. The puncturing device of claim 1, further comprising a signaling unit indicates whether the test parameter meets the test condition.

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

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

10. The puncturing device of claim 1, wherein the test sensor comprises a pressure sensor and the test parameter comprises pressure exerted on the contact element, further wherein the analytical unit initiates the puncturing operation at the end of the waiting period if the pressure exerted on the contact element remains within a predefined range of values during the waiting period.

26. The puncturing device of claim 1, wherein the signaling unit generates an optical signal indicating whether the test parameter meets the test condition.

27. The puncturing device of claim 26, further comprising a display that displays the optical signal.

11. 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;

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 a puncturing operation at the end of the waiting period; and

a signaling unit that generates a first signal indicating whether the test parameter meets the test condition and generates a second signal indicating the start of the waiting period, the first and second signals comprising user-recognizable optical, acoustic or vibratory signals.

12. The puncturing device of claim 11, 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, further 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.

13. The puncturing device of claim 11, further comprising:

a spring that compresses when the contact element presses against the body part, wherein the contact element moves relative to the housing; and

a pressure sensor that detects pressure exerted on the contact element, wherein the test parameter comprises pressure exerted on the contact element.

14. The puncturing device of claim 11, further comprising an operating element that allows a user to adjust the waiting period.

15. The puncturing device of claim 11, wherein the signaling unit generates a third user-recognizable optical, acoustic or vibratory signal indicating time remaining in the waiting period.

16. The puncturing device of claim 11, wherein the sensor comprises a pressure sensor and the test parameter comprises pressure exerted on the contact element, further wherein the analytical unit initiates the puncturing operation at the end of the waiting period if the pressure exerted on the contact element remains with a predefined range of values during the waiting period.

24. The puncturing device of claim 11, wherein at least one of the first and second signals comprises an optical signal.

25. The puncturing device of claim 24, further comprising a display that displays the optical signal.

17. 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;

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 a puncturing operation at the end of the waiting period; and

a signaling unit that generates a first signal indicating whether the test parameter meets the test condition and generates a second signal indicating elapsed time of the waiting period, the first and second signals comprising user-recognizable optical, acoustic or vibratory signals.

18. The puncturing device of claim 17, 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, further 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.

19. The puncturing device of claim 17, further comprising:

a spring that compresses when the contact element presses against the body part, wherein the contact element moves relative to the housing; and

a pressure sensor that detects pressure exerted on the contact element, wherein the test parameter comprises pressure exerted on the contact element.

20. The puncturing device of claim 17, further comprising an operating element that allows a user to adjust the waiting period.

21. The puncturing device of claim 17, wherein the signaling unit generates a third user-recognizable optical, acoustic or vibratory signal indicating the start of the waiting period.

22. The puncturing device of claim 17, wherein at least one of the first and second signals comprises an optical signal.

23. The puncturing device of claim 22, further comprising a display that displays the optical signal.