Method and apparatus for body fluid sampling with hybrid actuation

• US 20040087990A1
• Filed: 05/30/2003
• Published: 05/06/2004
• Est. Priority Date: 04/19/2002
• Status: Active Grant

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Pelikan Technologies, Inc.
• Inventors: Freeman, Dominique M., Boecker, Dirk, Alden, Don, Beadman, Mike, Schumann, Matt
• Granted Patent: US 8,267,870 B2
• Time in Patent Office: Days
• US Class Current: 606/181
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• 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 5/150183 Depth adjustment mechanism using end caps mounted at the distal end of the sampling device, i.e. the end-caps are adjustably positioned relative to the piercing device housing for example by rotating or screwing
• CPC Class Codes: A61B 5/150305 Packages specially adapted for piercing devices or blood sampling devices kits for diabetes A61M5/003; packaging in general B65D
• CPC Class Codes: A61B 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• 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 5/150824 by visual feedback
• 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 5/15117 comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
• 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 5/15169 Characterized by a rolled strip
• CPC Class Codes: A61B 5/15171 Characterized by propelling the piercing element perpendicular to the direction of movement of the strip
• CPC Class Codes: A61B 5/15176 Stocking means comprising cap, cover, sheath or protection for aseptic stocking
• CPC Class Codes: A61B 5/15182 : Means for keeping track or checking of the total number of piercing elements already used or the number of piercing elements still remaining in the stocking, e.g. by check window, counter, display
• CPC Class Codes: A61B 5/157 : Devices characterised by integrated means for measuring characteristics of blood

Abstract

In one aspect, a body fluid sampling device is provided using a penetrating member to extract fluid from an anatomical feature. The device comprises a penetrating member actuator for moving the penetrating member inbound towards the anatomical feature and a non-spring based, penetrating member retractor for moving the penetrating member outbound away from the anatomical feature. The penetrating member actuator may be adapted to move the penetrating member at a velocity greater than a velocity achieved by the penetrating member retractor.

Claims

1. A body fluid sampling device using a penetrating member to extract fluid from an anatomical feature, said device comprising:

a penetrating member actuator for moving the penetrating member inbound towards the anatomical feature; and

a non-spring based, penetrating member retractor for moving said penetrating member outbound away from the anatomical feature;

wherein said penetrating member actuator is adapted to move said penetrating member at a velocity greater than a velocity achieved by the penetrating member retractor.

2. The device of claim 1 wherein the penetrating member actuator uses a spring to move said penetrating member.

3. The device of claim 1 wherein the penetrating member retractor uses one of the following to move said penetrating member:

a motor and gear box, a nanomuscle, pneumatic device, a liquid magnetic coil actuation, a stepper motor, a micro-clutch device, and an inductive motor.

4. The device of claim 1 further comprising a plurality of penetrating members arranged in a radial configuration.

5. The device of claim 1 further comprising a plurality of penetrating members arranged in a radial configuration on a disc, with distal tips of said penetrating members pointed radially outward.

6. The device of claim 1 wherein said penetrating member actuator include a gripper block shaped to extend into a cartridge containing said penetrating member in order to engage said penetrating member.

7. The device of claim 1 wherein said penetrating member actuator includes a portion for breaking a seal on a cartridge containing said penetrating members, said portion breaking said seal to allow the actuator to engage the penetrating member.

8. The device of claim 1 further comprising at least one guide bearing in said cartridge for providing support in at least one of the following:

lateral guidance or vertical guidance.

9. The device of claim 1 further comprising a slidable cutter for removing a seal on a cartridge prior to penetrating member actuation.

10. The device of claim 1 further comprising a damper coupled to a coupler attaching the penetrating member to a penetrating member actuator.

11. The device of claim 1 further comprising a damper for slowing said penetrating member prior to said penetrating member reaching a hard stop.

12. The device of claim 1 further comprising a damper coupled to a drive shaft of the penetrating member actuator.

13. The device of claim 1 further comprising a damper for slowing the penetrating member on the inbound direction, said damper selected from one of the following:

a pneumatic damper, a fluid piston, a rubber stop, a frictional surface, a magnetic fluid based damper, or a rheonetic fluid based damper.

14. The device of claim 1 further comprising an optically reflective member coupled to a drive shaft of the penetrating member actuator, said optically reflective member used for determining the positioning.

15. The device of claim 1 further comprising a penetrating member coupler attached to the actuator and the retractor.

16. The device of claim 1 further comprising a cartridge containing a plurality of penetrating members.

17. The device of claim 1 further comprising a cartridge containing a plurality of penetrating members.

18. The device of claim 1 further comprising a drive shaft coupled to the penetrating member actuator and a penetrating member coupler.

19. The device of claim 1 further comprising a carrier coupled to said retractor and movable between a first position and a second position, said penetrating member actuator mounted on the carrier and movable with the carrier.

20. The device of claim 1 further comprising a friction damper having a plunger, said damper having a lumen with a funnel shaped portion and an elongate portion, said plunger sized to engage said elongate portion to provide damping.

21. The device of claim 1 further comprising a friction damper on said carrier for slowing said penetrating member, said friction damper shaped to provide variable resistance based on the position of a penetrating member coupler.

22. The device of claim 1 further comprising a reset latch coupled to said carrier, said reset latch holding a penetrating member coupler in place while the drive is compressed.

29. The device of claim 13 wherein said sample chamber is sized to hold no more than I microliter.

23. A body fluid sampling device for extracting bodily fluid from an anatomical feature, said device comprising:

a cartridge having a plurality of cavities;

a plurality of penetrating members, each slidably movable between a first position and a second position to extend outward from said cartridge to penetrate the anatomical feature; and

a penetrating member driver structured to selectively and independently engage said penetrating members, said driver comprising a first resilient member for moving an active one of the penetrating members on an inbound path toward the anatomical feature to create a wound, and a second resilient member for moving the active one of the penetrating members on an outbound path away from the wound.

24. The device of claim wherein said cartridge is disc shaped.

25. The device of claim wherein the first resilient member comprises a spring.

26. The device of claim wherein the second resilient member comprises a spring.

27. The device of claim further comprising a damper coupled to said penetrating member driver.

28. The device of claim further comprising a plurality of sample chambers on said cartridge.

30. A body fluid sampling device using a penetrating member to extract fluid from an anatomical feature, said device comprising:

a penetrating member driver, said driver selected from one of the following;

a motor and gear box, a nanomuscle, pneumatic device, a liquid magnetic coil actuation device, a stepper motor, a micro-clutch device, and an inductive motor;

a penetrating coupler attached to said driver, said coupler for releasably connecting the penetrating member to the driver.