Self optimizing lancing device with adaptation means to temporal variations in cutaneous properties

• US 7,316,700 B2
• Filed: 06/12/2002
• Issued: 01/08/2008
• Est. Priority Date: 06/12/2001
• Status: Expired due to Fees

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Pelikan Technologies, Inc.
• Inventors: Alden, Don, Freeman, Dominique M.
• Primary Examiner(s): Hayes; Michael J.
• Assistant Examiner(s): NGUYEN, VI X
• Application Number:
  US10/220,828
• Publication Number:
  US 20030233112A1
• Time in Patent Office: 2,036 Days
• Field of Search: 606181-186, 606/156, 606/169, 600/557, 600/573, 600/583, 604/46, 604197-198
• US Class Current: 606/181
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/15016 by accessories for bringing the piercing element into the body, e.g. through rotation of the piercing element
• CPC Class Codes: A61B 5/150167 Adjustable piercing speed of skin piercing element, e.g. blade, needle, lancet or canula, for example with varying spring force or pneumatic drive
• CPC Class Codes: A61B 5/150427 Specific tip design, e.g. for improved penetration characteristics
• CPC Class Codes: A61B 5/150435 Specific design of proximal end
• 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 5/151 Devices specially adapted for taking samples of capillary blood, e.g. by lancets , needles or blades
• CPC Class Codes: A61B 5/15123 comprising magnets or solenoids
• CPC Class Codes: A61B 5/1513 comprising linear sliding guides comprising tooth-shaped elements A61B5/15132

Abstract

A lancing device, an embodiment of which controls the advancement and retraction of a lancet by monitoring the position of the lancet in conjunction with a lancet controller which incorporates a feedback loop for modulating the lancet driver to follow a predetermined tissue lancing profile.

Claims

1. A lancing device comprising:

a lancet with a shaft having a proximal driving end and a distal lancing end;

a lancet driver coupled to said lancet for longitudinal displacement of said lancet; and

a lancet controller coupled to said lancet driver and configured to change a magnitude of force exerted on the lancet during a lancing cycle, said lancet controller including a feedback loop for monitoring a longitudinal displacement and velocity to provide a controlled acceleration of said lancet and for modulating the lancet driver to provide a predetermined tissue lancing profile having characteristic phases for lancet advancement and retraction; and

a position sensor coupled to the lancet and to the lancet controller, the position sensor and the lancet controller configured to measure

a distance from an initialization point to a point of contact of the lancet to a target tissue surface, the lancet being retracted by the driver to the initialization point with a distance to the target tissue being measured and a depth of penetration of the lancet determined.

2. A lancing device according to claim 1 wherein:

said lancet driver comprises a solenoid.

3. A lancing device according to claim 2 wherein:

said solenoid drives the lancet with electric current.

4. A lancing device according to claim 3 wherein:

said lancet controller comprises additional coil segments disposed adjacent to said solenoid for monitoring the lancet displacement.

5. A lancing device according to claim 1 wherein:

said lancet driver including a means for oscillating the lancet to improve the lancet cutting ability.

6. A lancing device according to claim 5 wherein:

said oscillating means includes a piezoelectric driver.

7. A lancing device according to claim 6 wherein:

said lancet controller controllably varies said tissue lancing profile as a function of impedance changes sensed from said piezoelectric driver resulting from said lancet interacting with said tissue.

8. A lancing device according to claim 5 wherein:

said lancet controller comprises a means for sensing a change in lancing pressure to determine the lancet displacement.

9. A lancing device according to claim 1 wherein:

said lancet controller comprises a processor for modulating the lancet driver.

10. A lancing device according to claim 9 wherein:

said processor comprises memory for storage and retrieval of a set of alternative lancing profiles which the processor uses to modulate the lancet driver.

11. A lancing device according to claim 10 wherein:

a user of said lancing device selects the profile desired from the alternative profiles to modulate the lancet.

12. A lancing device according to claim 9 wherein:

said processor optimizes said phases of said tissue lancing profile based on information entered by the user of said lancing device.

13. A lancing device according to claim 9 wherein:

said processor modulates the lancet driver by comparing an actual profile of the lancet to the profile and maintaining a preset error limit between the actual profile and the profile.

14. A lancing device according to claim 9 wherein:

said processor comprises a database for the user.

15. A lancing device according to claim 14 wherein:

said database allows the calculation of statistics for a profile.

16. A lancing device according to claim 9 or 14 wherein:

said processor comprises an internal clock which links the lancing event with a time stamp.

17. A lancing device according to claim 9 wherein:

said processor calculates an appropriate lancet diameter and geometry to collect a blood volume required by the user.

18. A lancing device according to claim 1 wherein:

said feedback loop further comprises a light detecting sensor and a light emitter for monitoring the relative position of said lancet.

19. A lancing device according to claim 1 wherein:

said feedback loop further comprises an electromagnetic sensor for monitoring the relative position of at least one magnetically permeable region disposed on a region of said shaft, said sensor comprising at least one solenoid.