Method and apparatus for body fluid sampling and analyte sensing

• US 20100274157A1
• Filed: 06/10/2010
• Published: 10/28/2010
• Est. Priority Date: 06/06/2003
• Status: Active Grant

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Inventors: Hegener, Jason, Boecker, Dirk, Alden, Don, Freeman, Dominique M., Beadman, Mike, Marsot, Travis, Schumann, Matt, Briggs, Barry Dean
• Granted Patent: US 8,251,921 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 5/150152 by an adequate mechanical impact on the puncturing location
• 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 5/150175 Adjustment of penetration depth
• 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 5/150755 Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• 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 5/15123 comprising magnets or solenoids
• CPC Class Codes: A61B 5/15151 Each piercing element being stocked in a separate isolated compartment
• CPC Class Codes: A61B 5/15161 Characterized by propelling the piercing element in a radial direction relative to the disc
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood

Abstract

A method of controlling a penetrating member is provided. The method comprises providing a lancing device comprising a penetrating member driver having a position sensor and a processor that can determine the relative position and velocity of the penetrating member based on measuring relative position of the penetrating member with respect to time; providing a predetermined velocity control trajectory based on a model of the driver and a model of tissue to be contacted. In some embodiments, a feedforward control to maintain penetrating member velocity along said trajectory.

Claims

1. A method of controlling penetrating member velocity, the method comprising.

advancing the penetrating member to reach a first desired velocity;

providing a controller for applying braking force;

applying variable amounts of braking force and driving force to follow a predicted velocity profile, checking in each braking cycle whether braking force should be varied.

2. A method of controlling penetrating member velocity, the method comprising:

controlling penetrating member depth by using an electronic lancet drive system where inbound penetration of the member to the skin is determined by the amount of force applied by the motor to achieve a certain velocity at impact with the skin.

3. A method of body fluid sampling comprising:

moving a penetrating member at conforming to a selectable velocity profile or motion waveform;

measuring force applied by user to a front end of a lancing device;

determining amount of tissue tenting;

recording tenting and force.

4. The method of claim 3 further comprising using force and tenting to determine stratum corneum thickness based on a slope of multiple force and tenting data points.

5. A device for body fluid sampling usable with a cartridge housing a plurality of penetrating members, the device comprising:

a housing;

a penetrating member driver coupled to said housing and for use with said cartridge;

a processor for controlling said penetrating member driver to move at least one of said penetrating members at velocities which conform with a selectable velocity profile;

a pressure transducer coupled to a front end of the housing where a user places a target tissue, said transducer sending measurements to the processor, said processor also measuring tenting of the tissue.

6. The device of claim 5 comprising a window allowing a user to see the cartridge while the cartridge is in said housing.

7. The device of claim 5 comprising display showing device status.

8. The device of claim 5 comprising display showing lancing performance.

9. The device of claim 5 comprising display showing lancing parameters.

10. The device of claim 5 comprising a single button for actuating said penetrating member driver along an inbound path into tissue and then an outbound path out of the tissue.

11. The device of claim 5 wherein said penetrating member driver moves an active one of said penetrating members along a velocity profile that reduces initial pain and residual pain to levels below that of known devices.

12. The device of claim 5 wherein said penetrating member driver moves an active one of said penetrating members along a velocity profile that reduces initial pain and residual pain to levels at least 1.5 times less than that of known devices.

13. The device of claim 5 wherein said penetrating member driver moves an active one of said penetrating members along a velocity profile that reduces residual pain to levels at least 2 times less than that of known devices.

14. A method of determining contact between a tip of a penetrating member and target tissue of a patient comprising:

(a) Providing a lancing device comprising a penetrating member driver having a position sensor and a processor that can determine the relative position and velocity of the penetrating member based on measuring relative position of the penetrating member with respect to time;

(b) Measuring a magnitude of deceleration of the penetrating member during at least a portion of the inward cutting stroke of the lancing cycle and comparing the magnitude of the measured deceleration to a known value of deceleration; and

(c) Determining contact if the magnitude of the measured deceleration is sufficiently greater than the magnitude of the known value of deceleration.