Method and apparatus for penetrating tissue

• US 8,403,864 B2
• Filed: 05/01/2006
• Issued: 03/26/2013
• Est. Priority Date: 04/19/2002
• Status: Expired due to Term

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Inventors: Boecker, Dirk, Alden, Don, Freeman, Dominique M.
• Primary Examiner(s): TOWA, RENE T
• Application Number:
  US11/417,312
• Publication Number:
  US 20060271083A1
• Time in Patent Office: 2,521 Days
• Field of Search: 600/573, 600575-579, 600/583, 606181-183
• US Class Current: 600/583
• CPC Class Codes: A61B 17/32093 for skin incisions
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• 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 5/150213 Venting means
• 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 5/15153 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 5/15176 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 5/157 : Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61M 2005/004 : Magazines with multiple needles directly inserted into an injection or infusion device, e.g. revolver-like magazines
• CPC Class Codes: B01L 2200/10 : Integrating sample preparation and analysis in single entity, e.g. lab-on-a-chip concept
• CPC Class Codes: B01L 2300/0663 : Whole sensors
• CPC Class Codes: B01L 2300/18 : Means for temperature control
• 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
• CPC Class Codes: B01L 3/502715 : characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces
• CPC Class Codes: G01N 33/4905 : Determining clotting time of blood by chemical methods G01N33/86, C12Q1/54
• CPC Class Codes: G01N 33/557 : using kinetic measurement, i.e. time rate of progress of an antigen-antibody interaction

Abstract

A tissue penetrating system has a housing member. A plurality of penetrating members are positioned in the housing member. A tissue stabilizing member is coupled to the housing. A penetrating member sensor is coupled to the plurality of penetrating members. The penetrating member sensor is configured to provide information relative to a depth of penetration of a penetrating member through a skin surface.

Claims

1. A tissue penetrating system, comprising:

a housing member;

a plurality of penetrating members positioned in a disposable in the housing member, the disposable having a plurality of penetrating member module portions each with a penetrating member channel, each of a penetrating member channel being parallel to a longitudinal axis of the disposable each of a penetrating member being free to slide in a respective penetrating member channel of the disposable with a sharpened tip of the penetrating member being withdrawn into a penetrating member channel to protect the tip and allow rotational motion between the disposable relative to the housing, a radial center of each penetrating member channel being disposed in a fixed, known radial distance from a longitudinal axis of the disposable to provide that each of a penetrating member channel is repeatably aligned in a functional arrangement with penetrating member channels of the disposable, the disposable configured to rotate about a pivot;

a plurality of analyte sensors, each of an analyte sensors being associated with a penetrating member,

an electronic penetrating member driver for driving each of the plurality of penetrating members;

a processor coupled to the electronic penetrating member driver, the processor including a user customizable velocity profile for setting penetration parameters of at least one of the plurality of penetrating members to successfully create the puncture wound with a desired degree of painlessness, success rate, and blood volume;

wherein the processor causes the electronic penetrating member driver to advance and retract said at least one penetrating member of the plurality of penetrating members with predetermined force to achieve said user customizable velocity profile; and

a penetrating member transport device for moving each of the plurality of penetrating members into a position for alignment with and to be driven by the penetrating member driver.

2. The system of claim 1, wherein a tissue stabilizing member is configured to enhance fluid flow from a target tissue.

3. The system of claim 1, wherein a tissue stabilizing member includes a plurality of protrusions.

4. The system of claim 1, wherein a tissue stabilizing member applies a vacuum to a target tissue.

5. The system of claim 1, wherein a tissue stabilizing member is configured to apply a force to a target tissue and cause the target tissue to press in an inward direction.

6. The system of claim 1, wherein a tissue stabilizing member applies a stimulation to a target tissue.

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

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

9. The system of claim 1, wherein the penetrating member sensor includes a capacitive incremental encoder.

10. The system of claim 1, wherein the penetrating member sensor includes an incremental encoder.

11. The system of claim 1, wherein the penetrating member sensor includes an optical encoder.

12. The system of claim 1, wherein the penetrating member sensor includes an interference encoder.

13. The system of claim 1, further comprising:

a sample chamber with an opening for transport of a body fluid into the sample chamber, the sample chamber being sized to receive no more than 1.0 μ

L of the body fluid.

14. The system of claim 1, further comprising:

a sample chamber with an opening for transport of a body fluid into the sample chamber, the sample chamber being sized to receive no more than 0.75 μ

L of the body fluid.

15. The system of claim 1, further comprising:

a sample chamber with an opening for transport of a body fluid into the sample chamber, the sample chamber being sized to receive no more than 0.5 μ

L of the body fluid.

16. The system of claim 1, further comprising:

a sample chamber with an opening for transport of a body fluid into the sample chamber, the sample chamber being sized to receive no more than 0.25 μ

L of the body fluid.

17. The system of claim 1, further comprising:

a sample chamber with an opening for transport of a body fluid into the sample chamber, the sample chamber being sized to receive no more than 0.1 μ

L of the body fluid.

18. The system of claim 1, further comprising:

an analyte detecting member coupled to a sample chamber, the analyte detecting member being configured to determine a concentration of an analyte in a body fluid using a sample that does not exceed a volume of 1 μ

L of a body fluid disposed in the sample chamber.

19. The system of claim 1, further comprising:

an analyte detecting member coupled to a sample chamber, the analyte detecting member being configured to determine a concentration of an analyte in a body fluid using a sample that does not exceed a volume of 0.75 μ

L of a body fluid disposed in the sample chamber.

20. The system of claim 1, further comprising:

an analyte detecting member coupled to a sample chamber, the analyte detecting member being configured to determine a concentration of an analyte in a body fluid using a sample that does not exceed a volume of 0.5 μ

L of a body fluid disposed in the sample chamber.

21. The system of claim 1, further comprising:

an analyte detecting member coupled to a sample chamber, the analyte detecting member being configured to determine a concentration of an analyte in a body fluid using a sample that does not exceed a volume of 0.25 μ

L of a body fluid disposed in the sample chamber.

22. The system of claim 1, further comprising:

an analyte detecting member coupled to a sample chamber, the analyte detecting member being configured to determine a concentration of an analyte in a body fluid using a sample that does not exceed a volume of 0.1 μ

L of a body fluid disposed in the sample chamber.

23. The system of claim 1, wherein each penetrating member is an elongated member without molded attachments.

24. The system of claim 1, further comprising:

a penetrating member transport device for moving each of a penetrating member into a position aligned with the penetrating member driver.

25. The system of claim 1, further comprising,

a belt for holding the penetrating members in an array configuration.

26. The system of claim 1, further comprising:

a tape device configured to hold the penetrating members in an array configuration.

27. The system of claim 1, further comprising:

a support channel configured to hold the penetrating members in an array configuration.

28. The system of claim 1, further comprising:

a cog configured to hold the penetrating members in an array configuration.

29. The system of claim 1, further comprising:

a plurality of connectors between penetrating members for holding the penetrating members in an array configuration.

30. The system of claim 1, further comprising:

a penetrating member sensor coupled to each of the plurality of penetrating members, the penetrating member sensor configured to provide information relative to a depth of penetration of a penetrating member through a skin surface.

31. The system of claim 30, wherein the depth of penetration is 100 to 2500 microns.

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

33. The system of claim 30, further comprising:

a feedback loop coupled to the penetrating member sensor.

34. The system of claim 30, wherein the depth of penetration is 500 to 750 microns.

35. The system of claim 34, wherein a 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 34, wherein a processor is utilized to monitor position and speed of a penetrating member as the penetrating member moves in a first direction.

37. The system of claim 34, wherein a processor is utilized to adjust an application of force to a penetrating member to achieve a desired speed of the penetrating member.

38. The system of claim 34, wherein a processor is utilized to adjust an application of force to a penetrating member when the penetrating member contacts a target tissue so that the penetrating member penetrates the target tissue within a desired range of speed.

39. The system of claim 34, wherein a processor is utilized to monitor position and speed of a penetrating member as the penetrating member moves in the first direction toward a target tissue, wherein the application of a launching force to the penetrating member is controlled based on position and speed of the penetrating member.

40. The system of claim 30, wherein the penetrating member driver is a voice coil drive force generator.

41. The system of claim 40, wherein a processor is utilized to control a withdraw force to the penetrating member so that the penetrating member moves in a second direction away from a target tissue.

42. The system of claim 40, wherein a speed of a penetrating member in a first direction is the range of 0.05 to 60 m/sec.

43. The system of claim 40, wherein a speed of a penetrating member in a first direction is the range of 0.1 to 20.0 m/sec.

44. The system of claim 40, wherein a speed of a penetrating member in a first direction is the range of 1.0 to 10.0 m/sec.

45. The system of claim 40, wherein a speed of a penetrating member in a first direction is the range of 3.0 to 8.0 m/sec.

46. The system of claim 40, wherein a dwell time of the penetrating member in a target tissue below a skin surface is in the range of 1 microsecond to 2 seconds.

47. The system of claim 30, wherein the penetrating member sensor is coupled to a processor with control instructions for the penetrating member driver.

48. The system of claim 47, wherein in a first direction the penetrating member moves toward the target tissue at a speed that is different than a speed at which the penetrating member moves away from a target tissue.

49. The system of claim 47, wherein in a first direction the penetrating member moves toward the target tissue at a speed that is greater than a speed at which the penetrating member moves away from a target tissue.

50. The system of claim 1, further comprising:

a seal formed by a fracturable material between the penetrating member and a cartridge, the seal being positioned at least one of a distal port or a proximal port of the cartridge.

51. The system of claim 50, further comprising

a second fracturable seal located at least one of the distal port or proximal port of cartridge.

52. The system of claim 1, further comprising:

a support structure for receiving the penetrating members.

53. The system of claim 52, wherein the support structure is a bandolier.

54. The system of claim 52, wherein the support structure is a drum.

55. The system of claim 52, wherein the support structure is a disc.