Method and apparatus for penetrating tissue

• US 20030199909A1
• Filed: 12/31/2002
• Published: 10/23/2003
• Est. Priority Date: 04/19/2002
• Status: Active Grant

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Pelikan Technologies, Inc.
• Inventors: Boecker, Dirk, Alden, Don, Freeman, Dominique M.
• Granted Patent: US 7,648,468 B2
• Time in Patent Office: Days
• US Class Current: 606/181
• 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 5/150068 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 5/150213 Venting means
• CPC Class Codes: A61B 5/150251 Collection chamber divided into at least two compartments, e.g. for division of samples injection syringes having more than one chamber A61M5/19; syringes for injection of two or more media A61M5/2448, A61M5/284; sample preparation for further analysis A61B5/150755
• 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 5/150435 Specific design of proximal end
• 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 5/150809 by audible feedback
• CPC Class Codes: A61B 5/150816 by tactile feedback, e.g. vibration
• CPC Class Codes: A61B 5/150824 by visual feedback
• CPC Class Codes: A61B 5/15087 short range, e.g. between console and disposable using implanted devices A61B5/150877
• CPC Class Codes: A61B 5/151 Devices specially adapted for taking samples of capillary blood, e.g. by lancets , needles or blades
• CPC Class Codes: A61B 5/15107 : Piercing being assisted by a triggering mechanism
• CPC Class Codes: A61B 5/15123 : comprising magnets or solenoids
• CPC Class Codes: A61B 5/15146 : Devices loaded with multiple lancets simultaneously, e.g. for serial firing without reloading, for example by use of stocking means. multiple simultaneous cutting or piercing A61B5/150977
• 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 5/15178 : 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 5/15186 : 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 2005/004 : 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 body fluid sampling system for use on a tissue site includes an electrically powered drive force generator. A penetrating member is operatively coupled to the force generator. The force generator moves the member along a path out of a housing having a penetrating member exit, into the tissue site, stops in the tissue site, and withdraws out of the tissue site. A cartridge houses the penetrating member. The cartridge has first and second seals coupled to the penetrating member to maintain a sterile environment around a portion of the penetration member prior to penetrating member actuation.

Claims

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

an electrically powered drive force generator;

a penetrating member operatively coupled to said force generator, said force generator moving said member along a path out of a housing having a penetrating member exit, into said tissue site, stopping in said tissue site, and withdrawing out of said tissue site;

a cartridge housing said penetrating member, said cartridge having a first and a second seal coupled to said penetrating member to maintain a sterile environment around a portion of the penetration member prior to penetrating member actuation.

2. A system as in claim 1 further comprising a penetrating member sensor positioned to monitor a penetrating member coupled to said force generator, the penetrating member sensor configured to provide information relative to a depth of penetration of a penetrating member through a skin surface.

3. The system of claim 2, wherein the depth of penetration is about 100 to 2500 microns.

4. The system of claim 2, wherein the depth of penetration is 500 to 750 microns.

5. The system of claim 2, wherein the depth of penetration is no more than about 1000 microns beyond a stratum corneum thickness of a skin surface.

6. The system of claim 2, wherein the depth of penetration is no more than about 500 microns beyond a stratum corneum thickness of a skin surface.

7. The system of claim 2, wherein the depth of penetration is no more than about 300 microns beyond a stratum corneum thickness of a skin surface.

8. The system of claim 2, wherein the depth of penetration is less than a sum of a stratum corneum thickness of a skin surface and 400 microns.

9. The system of claim 2, wherein the penetrating member sensor is further configured to provide an indication of velocity of a penetrating member.

10. The system of claim 1, wherein the active penetrating member moves along a substantially linear path into the tissue.

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

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

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

14. The system of claim 2, wherein the penetrating member sensor is coupled to a processor with control instructions for the penetrating member driver.

15. The system of claim 14, wherein the processor includes a memory for storage and retrieval of a set of penetrating member profiles utilized with the penetrating member driver.

16. The system of claim 14, wherein the processor is utilized to monitor position and speed of a penetrating member as the penetrating member moves in a first direction.

17. The system of claim 14, wherein the processor is utilized to adjust an application of force to a penetrating member to achieve a desired speed of the penetrating member.

18. The system of claim 14, wherein the 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 so that the penetrating member penetrates the target tissue within a desired range of speed.

19. The system of claim 14, wherein the 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.

20. The system of claim 19, wherein the processor is utilized to control a withdraw force to the penetrating member so that the penetrating member moves in a second direction away from the target tissue.

21. The system of claim 20, wherein in the 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 the target tissue.

22. The system of claim 20, wherein in the 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 the target tissue.

23. The system of claim 19, wherein a speed of a penetrating member in the first direction is the range of about 2.0 to 10.0 m/sec.

24. The system of claim 19, wherein a speed of a penetrating member in the first direction is the range of 0.05 to 60 m/sec.

25. The system of claim 19, wherein a speed of a penetrating member in the first direction is the range of 0.1 to 20.0 m/sec.

26. The system of claim 19, wherein a speed of a penetrating member in the first direction is the range of 1.0 to 10.0 m/sec.

27. The system of claim 19, wherein a speed of a penetrating member in the first direction is the range of 3.0 to 8.0 n/sec.

28. The system of claim 19, 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.

29. 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.

30. 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.

31. The system of claim 20, wherein the average velocity of the penetrating member during a tissue penetration stroke in the first direction is about 100 to about 1000 times greater than the average velocity of the penetrating member during a withdrawal stroke in a second direction.

32. The system of claim 1, further comprising:

a plurality of cartridges integrated in a cassette.

33. The system of claim 32, wherein each cartridge has an exit port, and upon launch each penetrating member exists from the exit port.

34. The system of claim 32 wherein unused cartridges are stored in a linear stack.

35. The system of claim 32 further comp rising a flexible support member coupling said cartridges together to define an array.

36. The system of claim 32, further comprising:

a plurality of connectors between said cartridges for holding said cartridges in an array configuration.

37. The system of claim 32, further comprising:

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

38. The system of claim 32, further comprising,

a belt for holding the cartridgess in an array configuration.

39. The system of claim 32, further comprising:

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

40. The system of claim 32, further comprising:

a tape device configured to hold the cartridges in an array configuration wherein said tape device defines a sack-like enclosure about each of said cartridges.

41. The system of claim 32, further comprising:

a tape device configured to hold the cartridges in an array configuration wherein said tape device defines an enclosure about each of said cartridges.

42. The system of claim 32, further comprising:

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

43. The system of claim 1, further comprising:

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

44. The system of claim 2, wherein the penetrating member sensor includes a capacitive incremental encoder.

45. The system of claim 2, wherein the penetrating member sensor includes an incremental encoder.

46. The system of claim 2, wherein the penetrating member sensor includes an optical encoder.

47. The system of claim 2, wherein the penetrating member sensor includes an interference encoder.

48. The system of claim 1 further comprising an analyte detecting member.

49. The system of claim 1 further comprising a plurality of analyte detecting members positioned to receive body fluid.

50. 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 mL of the body fluid.

51. 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 mL of the body fluid.

52. 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 mL of the body fluid.

53. 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 mL of the body fluid.

54. 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 mL of the body fluid.

55. The system of claim 1, further comprising:

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

56. The system of claim 1, further comprising:

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

57. The system of claim 1, further comprising:

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

58. The system of claim 1, further comprising:

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

59. 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 mL of a body fluid disposed in the sample chamber.

60. The system of claim 1, wherein each of a penetrating of the plurality of penetrating members has a packing density of no more than 1.0 cm3/penetrating member.

61. The system of claim 1, wherein each of a penetrating member of the plurality of penetrating members has a packing density of no more than 0.75 cm3/penetrating member.

62. The system of claim 1, wherein the each of a penetrating member of the plurality of penetrating members has a packing density of no more than 0.5 cm3/penetrating member.

63. The system of claim 1, wherein each of a penetrating member of the plurality of penetrating members has a packing density of no more than 0.25 cm3/penetrating member.

64. The system of claim 1, wherein each of a penetrating member of the plurality of penetrating members has a packing density of no more than 0.1 cm3/penetrating member.

65. The system of claim 50, wherein each of a penetrating member and an associated sample chamber have a combined packing density of no more than 1.0 cm3.

66. The system of claim 50, wherein each of a penetrating member and an associated sample chamber have a combined packing density of no more than 0.75 cm3.

67. The system of claim 50, wherein each of a penetrating member and an associated sample chamber have a combined packing density of no more than 0.5 cm3.

68. The system of claim 50, wherein each of a penetrating member and an associated sample chamber have a combined packing density of no more than 0.25 cm3.

69. The system of claim 50, wherein each of a penetrating member and an associated sample chamber have a combined packing density of no more than 0.1 cm3.

70. The system of claim 50 further comprising a third seal covering an entrance to said sample chamber.

71. The system of claim 1, further comprising:

a tissue stabilizer device coupled to the housing.

72. The system of claim 71, wherein the tissue stabilizer device is configured to enhance fluid flow from a target tissue.

73. The system of claim 71, wherein the tissue stabilizer device creates a stretching of a skin surface.

74. The system of claim 71, wherein the tissue stabilizer device includes a plurality of protrusions.

75. The system of claim 71, wherein the tissue stabilizer device applies a vacuum to a target tissue.

76. The system of claim 71, wherein the tissue stabilizer device is configured to apply a force to a target tissue and cause the target tissue to press in an inward direction relative to the housing member.

77. The system of claim 71, wherein the tissue stabilizing member applies a stimulation to a target tissue.

78. The system of claim 1 wherein said seals are formed by a fracturable material between the penetrating member and the cartridge, at least one of said seals being positioned at least one of a distal port or a proximal port of the cartridge.

79. The system of claim 71, further comprising

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

80. The system of claim 71, further comprising

at least three fracturable seal between the penetrating member and the cartridge.

81. The system of claim 1, wherein each penetrating member each penetrating members is an elongate member without molded attachments.

82. The system of claim 1, wherein said cartridge comprises a first housing portion and a second housing portion.

83. The system of claim 1 further comprising a vacuum source to provide a low pressure environment to draw fluid from a wound created by the penetrating member in the tissue.

84. The system of claim 1 wherein the penetrating member exit is configured to be positioned against the tissue when the penetrating member contacts the tissue.

85. The system of claim 1, further comprising:

a support structure for receiving the penetrating members.

86. The system of claim 85, wherein the support structure is a bandolier.

87. The system of claim 85, wherein the support structure is a drum.

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

an electrically powered drive force generator;

a penetrating member operatively coupled to said force generator, said force generator moving said member along a path out of a housing having a penetrating member exit, into said tissue site, stopping in said tissue site, and withdrawing out of said tissue site;

a cartridge housing said penetrating member, said cartridge having a first and a second seal coupled to said penetrating member to maintain a sterile environment around a portion of the penetration member prior to penetrating member actuation.

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

a drive force generator;

a penetrating member operatively coupled to said force generator, said force generator moving said member along a path out of a housing having a penetrating member exit, into said tissue site, stopping in said tissue site, and withdrawing out of said tissue site;

said drive force generator configured to be controlled to follow a predetermined velocity trajectory into the tissue and out of said tissue;

a cartridge housing said penetrating member, said cartridge having a first and a second seal coupled to said penetrating member to maintain a sterile environment around a portion of the penetration member prior to penetrating member actuation.

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

a drive force generator;

a penetrating member operatively coupled to said force generator, said force generator moving said member along a path out of a housing having a penetrating member exit, into said tissue site, stopping in said tissue site, and withdrawing out of said tissue site;

a position sensor positioned to provide an indication of a position of the penetrating member during actuation;

a cartridge housing said penetrating member, said cartridge having a first and a second seal coupled to said penetrating member to maintain a sterile environment around a portion of the penetration member prior to penetrating member actuation.

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

a drive force generator;

a penetrating member operatively coupled to said force generator, said force generator moving said member along a path out of a housing having a penetrating member exit, into said tissue site, stopping in said tissue site, and withdrawing out of said tissue site;

wherein said penetrating member is an elongate member without a molded attachment;

a coupler on said force generator configured to engage at least a portion of said elongate portion of the penetrating member and drive said member along a path into a tissue site and withdrawn from a tissue site;

a cartridge housing said penetrating member, said cartridge having a first and a second seal coupled to said penetrating member to maintain a sterile environment around a portion of the penetration member prior to penetrating member actuation.

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

a drive force generator;

a plurality of cartridges each containing a penetrating member, each of said cartridges coupled together to define a flexible array;

a transport device for moving each of said cartridges into a launch position operatively coupling said penetrating member to the force generator;

each cartridge having a first and a second seal coupled to said penetrating member to maintain a sterile environment around a portion of the penetration member prior to penetrating member actuation.

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

a drive force generator;

a penetrating member having an elongate portion without a molded attachment and operatively coupled to said force generator;

a sterility enclosure covering at least a tip of said penetrating member, said sterility enclosure removed from said penetrating member prior to actuation of the member and positioned so that the penetrating member will not contact said enclosure during actuation.

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

a drive force generator;

a penetrating member having an elongate portion without a molded attachment and operatively coupled to said force generator;

a sterility enclosure creating a sterile environment around at least a tip of said penetrating member, said penetrating member breaching said sterile environment during actuation.

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

a drive force generator;

a penetrating member operatively coupled to said force generator, said force generator moving said member along a path out of a housing having said a penetrating member exit, into said tissue site, stopping in said tissue site, and withdrawing out of said tissue site;

a skin stabilizer device suitable for stretching a surface of a tissue site, said skin stabilizer at least partially surrounding the penetrating member exit;

a cartridge housing said penetrating member, said cartridge having a first and a second seal coupled to said penetrating member to maintain a sterile environment around a portion of the penetration member prior to penetrating member actuation.

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

a drive force generator;

;

a penetrating member operatively coupled to said force generator, said force generator moving said member along a path out of a housing having said a penetrating member exit, into said tissue site, stopping in said tissue site, and withdrawing out of said tissue site;

a user interface for transmitting at least one input between a user;

a cartridge housing said penetrating member, said cartridge having a first and a second seal coupled to said penetrating member to maintain a sterile environment around a portion of the penetration member prior to penetrating member actuation.

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

a drive force generator;

a penetrating member operatively coupled to said force generator, said force generator moving said member along a path out of a housing having a penetrating member exit, into said tissue site, stopping in said tissue site, and withdrawing out of said tissue site;

an analyte detection member positioned to receive fluid from a wound created by said penetrating member, said detection member configured to determine a concentration of an analyte in the fluid using a sample of less than 1 mL of the fluid;

a cartridge housing said penetrating member, said cartridge having a first and a second seal coupled to said penetrating member to maintain a sterile environment around a portion of the penetration member prior to penetrating member actuation.