METHOD AND APPARATUS FOR LANCET LAUNCHING DEVICE INTEGRATED ONTO A BLOOD-SAMPLING CARTRIDGE

• US 20070239190A1
• Filed: 06/15/2007
• Published: 10/11/2007
• Est. Priority Date: 06/12/2001
• Status: Active Grant

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Inventors: Lum, Paul, Alden, Don, Freeman, Dominique
• Granted Patent: US 8,282,577 B2
• Time in Patent Office: Days
• US Class Current: 606/181
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• 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 5/150748 Having means for aiding positioning of the piercing device at a location where the body is to be pierced means for aiding positioning of devices for bringing media into the body A61M5/427, locating blood vessels A61B5/489
• CPC Class Codes: A61B 5/150809 by audible feedback
• CPC Class Codes: A61B 5/150832 by topography of the surface, e.g. Braille, embossed printing
• 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 5/15142 Devices intended for single use, i.e. disposable
• CPC Class Codes: A61B 5/15186 Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use
• CPC Class Codes: A61B 5/1519 comprising driving means, e.g. a spring, for propelling the piercing unit
• CPC Class Codes: A61B 5/15194 fully automatically retracted, i.e. the retraction does not require a deliberate action by the user, e.g. by terminating the contact with the patient's skin
• CPC Class Codes: B01L 2200/027 for microfluidic devices
• CPC Class Codes: B01L 2200/143 Quality control, feedback systems
• CPC Class Codes: B01L 2300/0816 Cards, e.g. flat sample carriers usually with flow in two horizontal directions
• CPC Class Codes: B01L 2400/0406 capillary forces
• CPC Class Codes: B01L 3/5027 by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip B01L3/5023 takes precedence; micromixers B01F33/30; microreactors for synthesis B01J19/0093; microcapillary devices in general B81B1/00

Abstract

A method and apparatus (2) for obtaining a sample of blood. An embodiment consists of an apparatus (2) which integrates lancing (12), sample collection, and analysis. The presence of patients finger on the active sampling area can be sensed by monitoring the pressure applied by the finger on the device (2).

Claims

1. A body fluid sampling system for use on a tissue site, comprising:

a drive force generator;

a housing with at least a proximal portion and a distal portion, the proximal portion being a handle portion configured to be held by a user, at least a portion of the distal portion having an ergonomically contoured surface adapted to conform to a tip of a finger;

a plurality of sample chambers and a plurality of penetrating members operatively couplable to the drive force generator, each of a sample chamber being associated with a penetrating member;

a disposable that houses the plurality of sample chambers and the plurality of penetrating members, the disposable being positioned in the distal portion of the housing.

2. The system of claim 1, wherein the ergonomically contoured surface is shaped to snugly fit the tip of the finger.

3. The system of claim 1, further comprising:

a display coupled to the housing.

4. The system of claim 1, further comprising:

a user control pad coupled to the housing.

5. The system of claim 1, further comprising:

a battery door coupled to the housing.

6. The system of claim 4, wherein the user control pad has a plurality of function keys.

7. The system of claim 6, wherein at least one of a user'"'"'s hand digits can access the function keys.

8. The system of claim 6, wherein the plurality of function keys are arranged in a circular geometry.

9. The system of claim 6, wherein the function keys are arranged as direction arrows in a circular geometry.

10. The system of claim 6, wherein the function keys include a center function key with function keys in a surrounding relationship to the center function key to provide for up, down, left and right movement.

11. The system of claim 4, wherein the user uses the control pad to provide for up, down, left, right, center and then presses enter.

12. The system of claim 3, wherein the display is backlit.

13. The system of claim 3, wherein the display hides in the housing in an off mode.

14. The system of claim 1, wherein the housing includes a door for introducing and removing the disposable to and from the housing.

15. The system of claim 14, wherein the door is a hinged door coupled to the housing.

18. The system of claim 1, further comprising:

a sliding shutter that covers and protects a front end of the housing.

19. The system of claim 18, wherein the sliding shutter is configured to slide around a curvature of the head section.

20. The system of claim 18, wherein the sliding shutter includes a latch or detent feature to provide that the shutter is not accidentally opened.

21. The system of claim 1, further comprising:

a user interface coupled to a processor, wherein in response to an input at the user interface by a user the processor provides an input to a penetrating member driver to relay a lancing penetration parameter selected from at least one of, penetrating member depth of penetration, penetrating member velocity, penetrating member braking, or penetrating member retraction from a tissue site.

22. The system of claim 1, further comprising:

a user interface coupled to a process, wherein the user interface is configured to provide a user with at least one input selected from, depth of a penetrating member penetration, velocity of a penetrating member, a desired velocity profile, a velocity of a penetrating member into the target tissue, velocity of the penetrating member out of the target tissue, dwell time of the penetrating member in the target tissue, and a target tissue relaxation parameter.

23. The system of claim 1, further comprising:

a user interface coupled to a processor, wherein the user interface provides at least one output to the user selected from, number of penetrating members available, number of penetrating members used, actual depth of penetrating member penetration on a target tissue, stratum corneum thickness, force delivered on a target tissue, energy used by a penetrating member driver to drive a penetrating member into the target tissue, dwell time of the penetrating member, battery status, system status, consumed energy, speed profile of a penetrating member, information relative to contact of a penetrating member with target tissue before penetration by the penetrating member, and information relative to a change of speed of a penetrating member as in travels in the target tissue.

24. The system of claim 1, further comprising:

a data interface configured to couple the tissue penetrating system to at least one of, support equipment with a data interface and the internet.

25. The system of claim 1, wherein, each of a sample chamber has a volume of no greater than 1 microliter.

26. The system of claim 1, wherein the disposable has a geometry selected from at least one of a drum, disk, magazine and bandolier.

27. The system of claim 1, wherein the disposal is rotatable within the distal portion of the housing.

28. The system of claim 1, further comprising:

a flexible support member coupling the penetrating members and configured to move each of the penetrating members to a launch position associated with the force generator.

29. The system of claim 1, further comprising:

a penetrating member sensor positioned to monitor a penetrating member coupled to the force generator, the penetrating member sensor configured to provide information relative to a depth of penetration of a penetrating member through a skin surface.

30. The system of claim 29, wherein the penetrating member sensor is further configured to provide an indication of velocity of a penetrating member.

31. The system of claim 1, wherein an active penetrating member is launched from the housing along a substantially linear path into the tissue.

32. The system of claim 1, wherein the active penetrating member moves along an at least partially curved path into the tissue.

33. The system of claim 1, wherein the driver is a voice coil drive force generator.

34. The system of claim 1, wherein the driver is a rotary voice coil drive force generator.

35. The system of claim 1, further comprising:

a processor, wherein the processor includes a memory for storage and retrieval of a set of penetrating member profiles utilized with the penetrating member driver.

36. The system of claim 1, wherein in a first direction into the tissue the penetrating member moves toward the target tissue at a first speed and withdraws out of the tissue at a second speed.

37. The system of claim 36, wherein the first and second speeds are the same.

38. The system of claim 36, wherein the first speed is greater than the second speed.

39. The system of claim 36, wherein the first speed is about 2.0 to 10.0 m/sec.

40. The system of claim 36, wherein the first speed is about 0.05 to 60 m/sec.

41. The system of claim 36, wherein the first speed is about 0.1 to 20.0 m/sec.

42. The system of claim 36, wherein the first speed is about 1.0 to 10.0 m/sec.

43. The system of claim 36, wherein the first speed is about 3.0 to 8.0 m/sec.

44. The system of claim 1, wherein a dwell time of the penetrating member in the target tissue below a skin surface is in the range of 1 microsecond to 2 seconds.

45. The system of claim 1, wherein a dwell time of the penetrating member in the target tissue below a skin surface is in the range of 500 milliseconds to 1.5 second.

46. The system of claim 1, wherein a dwell time of the penetrating member in the target tissue below a skin surface is in the range of 100 milliseconds to 1 second.

16. The system of 1, wherein at least a portion of the head section of the housing is symmetrical.

17. The system of claim 16, wherein at least a portion of the head section is rounded.