Tissue penetrating apparatus

• US 20090209883A1
• Filed: 01/15/2009
• Published: 08/20/2009
• Est. Priority Date: 01/17/2008
• Status: Abandoned Application

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Inventors: BOECKER, DIRK, HIGGINS, MICHAEL, LOERWALD, DIETER, RHODES, BRAD, EVANS, WILLIAM, GREENBERG, DIANA
• Application Number:
  US12/354,173
• Publication Number:
  US 20090209883A1
• Time in Patent Office: Days
• US Class Current: 600/575
• 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 5/150061 Means for enhancing collection
• CPC Class Codes: A61B 5/150068 by tissue compression, e.g. with specially designed surface of device contacting the skin area to be pierced
• CPC Class Codes: A61B 5/150099 by negative pressure, other than vacuum extraction into a syringe by pulling on the piston rod or into pre-evacuated tubes
• 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 5/15019 Depth adjustment mechanism using movable stops located inside the piercing device housing and limiting the travel of the drive mechanism mechanisms using distal end caps A61B5/150183, mechanisms at the piercing element carrier proximal end A61B5/150198
• CPC Class Codes: A61B 5/150213 Venting means
• CPC Class Codes: A61B 5/150221 Valves
• 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 5/150427 Specific tip design, e.g. for improved penetration characteristics
• 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 5/150572 Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
• 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 5/15153 Multiple piercing elements stocked in a single compartment
• CPC Class Codes: A61B 5/15163 : Characterized by propelling the piercing element in an axial 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 5/15174 : Piercing elements stocked in the form of a stack or pile
• CPC Class Codes: A61B 5/15176 : Stocking means comprising cap, cover, sheath or protection for aseptic stocking
• CPC Class Codes: A61B 5/15178 : Stocking means comprising separate compartments or units for new and for used piercing elements separate compartments for used piercing elements in piercing devices A61B5/15184
• CPC Class Codes: A61B 5/15184 : Piercing device comprising a separate compartment or unit for used piercing elements separate compartments for used piercing elements in stocking means A61B5/15178
• 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 5/157 : Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61M 2005/005 : Magazines with multiple ampoules directly inserted into an injection or infusion device, e.g. revolver-like magazines containing ampoules with or without needles
• CPC Class Codes: A61M 2005/206 : With automatic needle insertion
• CPC Class Codes: A61M 2205/502 : User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 5/20 : Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically A61M5/142 , A61M5/46 take precedence; hypodermic projectiles F42B12/54
• CPC Class Codes: A61M 5/2425 : by compression of deformable ampoule or carpule wall
• CPC Class Codes: A61M 5/3287 : Accessories for bringing the needle into the body; Automatic needle insertion A61M5/20, A61M5/31525 take precedence
• CPC Class Codes: A61M 5/3291 : Shafts with additional lateral openings
• CPC Class Codes: G16H 40/63 : for local operation

Abstract

A body fluid sampling system is provided for use on a tissue site. A drive force generator is provided. A housing has at least a first handle portion with a first average diameter, and a head portion with a second average diameter that is larger than the first average diameter. The housing includes a plurality of analyte sensors and a plurality of sample chambers. Each analyte sensor is associated with a sample chamber and is configured to receive body fluid from a wound in tissue created by a penetrating member. A plurality of penetrating members are operatively coupled to the drive force generator. The drive force generator moves each of the penetrating members along a path out of the housing into the tissue site, stops in the tissue site, and withdraws out of the tissue site. Each penetrating member is at least partially positioned adjacent to an analyte sensor in a sample chamber. A user interface is included.

Claims

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

a drive force generator;

a housing with at least a first handle portion with a first average diameter, and a head portion with a second average diameter that is larger than the first average diameter, the housing including a plurality of analyte sensors and a plurality of sample chambers, each of an analyte sensor being associated with a sample chamber and configured to receive body fluid from a wound in tissue created by a penetrating member;

a plurality of penetrating members operatively coupled to the drive force generator, the drive force generator moving each of the penetrating members along a path out of the housing into the tissue site, stopping in the tissue site, and withdrawing out of the tissue site;

each of a penetrating member at least partially positioned adjacent to an analyte sensor in a sample chamber; and

a user interface.

2. The system of claim 1, wherein the penetrating members and the analyte sensors are positioned in the head portion of the housing.

3. The system of claim 1, wherein the handle is sized to be held by a user'"'"'s hand during use of the system by a user.

4. The system of claim 1, wherein the head portion serves as a stop of movement of the system in a user'"'"'s hand.

5. The system of claim 1, further comprising:

a display coupled to the housing.

6. The system of claim 1, further comprising:

a user control pad coupled to the housing.

7. The system of claim 1, further comprising:

a battery door coupled to the housing.

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

9. The system of claim 8, wherein at least one of a user'"'"'s hand digits can access the function keys.

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

11. The system of claim 8, wherein the function keys are arranged as direction arrows in a circular geometry.

12. The system of claim 8, 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.

13. The system of claim 6, wherein the user uses the control pad to provide for up, down, left, right, center and then presses enter.

14. The system of claim 5, wherein the display is backlit.

15. The system of claim 5, wherein the display hides in the housing in an off mode.

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

17. The system of claim 16, wherein the door is a hinged door coupled to the housing.

20. The system of claim 1, further comprising:

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

21. The system of claim 20, wherein the sliding shutter is configured to slide around a curvature of the head section.

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

23. The system of claim 1, wherein the user interface is 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.

24. The system of claim 1, further wherein the user interface is coupled to a processor, 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.

25. The system of claim 1, wherein the user interface is 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.

26. 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.

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

28. The system of claim 1, wherein the head portion has a substantially cylindrical geometric configuration.

29. The system of claim 1, wherein the analyte members and the analyte sensors are housed in a disposable that is positionable in the head portion of the housing.

30. The system of claim 29, wherein the disposable has a geometry selected from at least one of a drum, disk, magazine and bandolier.

31. The system of claim 29, wherein the disposal is rotatable within the head portion of the housing.

32. 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.

33. 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.

34. The system of claim 33, wherein the penetrating member sensor is further configured to provide an indication of velocity of a penetrating member.

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

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

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

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

39. 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.

40. 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.

41. The system of claim 40, wherein the first and second speeds are the same.

42. The system of claim 40, wherein the first speed is greater than the second speed.

43. The system of claim 40, wherein the first speed is about 2.0 to 10.0 m/sec.

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

45. The system of claim 40, wherein the first speed is about 0.1 to 20.0 m/sec.

46. The system of claim 40, wherein the first speed is about 1.0 to 10.0 m/sec.

47. The system of claim 40, wherein the first speed is about 3.0 to 8.0 m/sec.

48. 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.

50. 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.

51. 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.

52. The system of claim 1, further comprising:

a processor coupled to the drive force generator, the processor including control instructions that implement, controlling impact, retraction velocity, and dwell time of the penetrating member within a tissue site.

53. The system of claim 52, wherein the processor provides feedback control to the drive force generator.

54. The system of claim 53, wherein the feedback control is based on at least one of, penetrating member displacement, velocity, and acceleration.

55. The system of claim 54, wherein feedback control information relating to a penetrating member path is returned to the processor.

56. The system of claim 55, wherein the feedback control information regulates an amount of energy to the drive force.

57. The system of claim 52, wherein the processor provides control of the drive force generator to provide that retraction of the penetrating member is at a lower than a an in-bound velocity through the tissue site.

58. The system of claim 52, wherein the processor stores driver profiles of lancing events or user profiles in a memory.

59. The system of claim 58, wherein the processor is adapted to receive user input information about desired circumstances or parameters for a lancing event.

60. The system of claim 58, wherein the processor is configured to select a driver profile from a set of alternative driver profiles that have been preprogrammed in the processor based on desired tissue penetration device performance.

61. The system of claim 58, wherein the processor is configured to customize a profile by modifying the profile based on additional user input information.

62. The system of claim 58, wherein the processor measures a location of the penetrating member using a penetrating member position sensor

63. The system of claim 58, wherein the processor is configured to calculate movement of the penetrating member by comparing an actual profile of the penetrating member to a predetermined profile.

64. The system of claim 58, wherein following a lancing event the processor is configured to allow the user to rank the results of the lancing event.

65. The system of claim 64, wherein the processor stores the results that have been ranked and construct a database for the individual user.

66. The system of claim 65, wherein the processor accesses the database to calculate profile traits.

67. The system of claim 66, wherein the processor optimizes profiles for each user.

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

19. The system of claim 18, wherein at least a portion of the head section is rounded.