Method and apparatus for penetrating tissue

• US 20090192411A1
• Filed: 01/27/2009
• Published: 07/30/2009
• Est. Priority Date: 04/19/2002
• Status: Active Grant

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Inventors: Freeman, Dominique
• Granted Patent: US 8,556,829 B2
• Time in Patent Office: Days
• US Class Current: 600/583
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• CPC Class Codes: A61B 5/1427 Multiple blood sampling, e.g. at periodic or pre-established intervals
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
• 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 5/150221 Valves
• CPC Class Codes: A61B 5/150343 Collection vessels for collecting blood samples from the skin surface, e.g. test tubes, cuvettes sampling from within body cavities A61B5/150015, A61B5/150045
• 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 5/150427 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 5/150755 Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• 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 5/15113 Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
• CPC Class Codes: A61B 5/15123 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 5/15176 : 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 5/15194 : 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: A61B 5/157 : Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61B 5/6886 : Monitoring or controlling distance between sensor and tissue
• CPC Class Codes: A61M 5/3295 : Multiple needle devices, e.g. a plurality of needles arranged coaxially or in parallel

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 the housing member, and a pressure applicator coupled to the housing member.

2. The system of claim 1, wherein the pressure applicator is configured to enhance fluid flow from a target tissue.

3. The system of claim 1, wherein the tissue stabilizer member creates a stretching of a skin surface.

4. The system of claim 1, wherein the pressure applicator includes a plurality of protrusions.

5. The system of claim 1, wherein the pressure applicator applies a vacuum to a target tissue.

6. The system of claim 1, wherein the pressure applicator 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.

7. The system of claim 1, wherein the tissue stabilizing device applies a stimulation to a target tissue.

8. The system of claim 1, wherein the depth of penetration is 100 to 2500 microns.

9. The system of claim 1, wherein the depth of penetration is 500 to 750 microns.

10. The system of claim 1, wherein the penetrating member sensor is further configured to provide an indication of velocity of a penetrating member.

11. The system of claim 1, further comprising:

a second penetrating member sensor configured to provide an indication of velocity of a penetrating member.

12. The system of claim 1, further comprising:

a feedback loop coupled to the penetrating member sensor.

13. The system of claim 1, wherein the penetrating member driver is an electric drive force member.

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

15. The system of claim 1, wherein the penetrating member sensor is coupled to a processor with control instructions for the penetrating member driver.

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

17. The system of claim 15, wherein the processor is utilized to monitor position and speed of a penetrating member as the penetrating member moves in a first direction.

18. The system of claim 15, wherein the processor is utilized to adjust an application of force to a penetrating member to achieve a desired speed of the penetrating member.

19. The system of claim 15, 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 within a desired range of speed.

20. The system of claim 15, 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.

21. The system of claim 20, 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.

22. The system of claim 21, 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.

23. The system of claim 21, 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.

24. The system of claim 20, 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 20, 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 20, 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 20, wherein a speed of a penetrating member in the first direction is the range of 3.0 to 8.0 m/sec.

28. The system of claim 20, 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 1, further comprising:

a plurality of cartridges integrated in a cassette.

32. The system of claim 31, wherein each cartridge has an exit port, and upon launch each penetrating member exists from the exit port.

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

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

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

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

37. The system of claim 1, further comprising:

an analyte detecting member.

38. The system of claim 1, further comprising:

a plurality of analyte detecting members each coupled to a penetrating member.

39. 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 .mu.L of the body fluid.

40. 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 .mu.L of the body fluid.

41. 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 .mu.L of the body fluid.

42. 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 .mu.L of the body fluid.

43. 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 .mu.L of the body fluid.

44. 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 .mu.L of a body fluid disposed in the sample chamber.

45. 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 .mu.L of a body fluid disposed in the sample chamber.

46. 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 .mu.L of a body fluid disposed in the sample chamber.

47. 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 .mu.L of a body fluid disposed in the sample chamber.

48. 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 .mu.L of a body fluid disposed in the sample chamber.

49. 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 cm.sup.3/penetrating member.

50. 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 cm.sup.3/penetrating member.

51. 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 cm.sup.3/penetrating member.

52. 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 cm.sup.3/penetrating member.

53. 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 cm.sup.3/penetrating member.

54. The system of claim 39, wherein each of a penetrating member and an associated sample chamber have a combined packing density of no more than 1.0 cm.sup.3.

55. The system of claim 39, wherein each of a penetrating member and an associated sample chamber have a combined packing density of no more than 0.75 cm.sup.3.

56. The system of claim 39, wherein each of a penetrating member and an associated sample chamber have a combined packing density of no more than 0.5 cm.sup.3.

57. The system of claim 39, wherein each of a penetrating member and an associated sample chamber have a combined packing density of no more than 0.25 cm.sup.3.

58. The system of claim 39, wherein each of a penetrating member and an associated sample chamber have a combined packing density of no more than 0.1 cm.sup.3

59. 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.

60. The system of claim 59, further comprising:

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

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

62. 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.

63. The system of claim 1, further comprising:

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

64. The system of claim 1, further comprising:

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

65. The system of claim 1, further comprising:

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

66. The system of claim 1, further comprising:

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

67. The system of claim 1, further comprising:

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

68. The system of claim 1, further comprising:

a support structure for receiving the penetrating members.

69. The system of claim 68, wherein the support structure is a bandolier.

70. The system of claim 68, wherein the support structure is a drum.

71. The system of claim 68, wherein the support structure is a disc.

83. The system of claim 1, wherein the tissue stabilizer member is configured to enhance fluid flow from a target tissue.

84. The system of claim 1, wherein the tissue stabilizer member creates a stretching of a skin surface.

85. The system of claim 1, wherein the tissue stabilizer member includes a plurality of protrusions.

86. The system of claim 1, wherein the tissue stabilizer member applies a vacuum to a target tissue.

87. The system of claim 1, wherein the tissue stabilizer member 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.

88. The system of claim 1, wherein the tissue stabilizing device applies a stimulation to a target tissue.

90. The system of claim 1, wherein the tissue stabilizer member is configured to enhance fluid flow from a target tissue.

91. The system of claim 1, wherein the tissue stabilizer member creates a stretching of a skin surface.

92. The system of claim 1, wherein the tissue stabilizer member includes a plurality of protrusions.

93. The system of claim 1, wherein the tissue stabilizer member applies a vacuum to a target tissue.

94. The system of claim 1, wherein the tissue stabilizer member 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.

95. The system of claim 1, wherein the tissue stabilizing device applies a stimulation to a target tissue.

97. The system of claim 1, wherein the tissue stabilizer member is configured to enhance fluid flow from a target tissue.

98. The system of claim 1, wherein the tissue stabilizer member creates a stretching of a skin surface.

99. The system of claim 1, wherein the tissue stabilizer member includes a plurality of protrusions.

100. The system of claim 1, wherein the tissue stabilizer member applies a vacuum to a target tissue.

101. The system of claim 1, wherein the tissue stabilizer member 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.

102. The system of claim 1, wherein the tissue stabilizing device applies a stimulation to a target tissue.

72. A tissue penetrating system, comprising:

a housing member;

a plurality of penetrating members; and

a stimulating member coupled to the housing member and configured to increase blood circulation at a skin surface.

73. A tissue penetrating system, comprising:

a housing member;

a plurality of penetrating members; and

a stimulating vibratory member coupled to the housing member and configured to apply a vibratory motion to a skin surface.

74. A method of obtaining a sample of capillary whole blood from a target tissue, comprising

providing a penetrating system that includes a tissue stabilizing member;

applying skin stimulation to a skin surface site with the tissue stabilizing member;

introducing a penetrating member through the skin surface site to form an incision; and

collecting blood from the incision in the penetrating system.

75. The method of claim 74, wherein the skin stimulation is a vibratory motion applied to the skin surface.

76. The method of claim 74, wherein the skin stimulation increases blood circulation at the skin surface.

77. The method of claim 74, further comprising:

monitoring position and speed of a penetrating member as the penetrating member moves in the first direction toward the skin target.

78. The method of claim 74, further comprising:

adjusting an application of force to a penetrating member to achieve a desired speed of the penetrating member.

79. The method of claim 74, further comprising:

adjusting an application of force to a penetrating member when the penetrating member contacts a skin target so that the penetrating member penetrates the skin target within a desired range of speed.

80. The method of claim 74, further comprising:

monitoring position and speed of a penetrating member as the penetrating member moves in a first direction toward the skin target, wherein the application of a launching force to the penetrating member is controlled based on position and speed of the penetrating member.

81. The method of claim 74, further comprising:

controlling a withdraw force to the penetrating member so that the penetrating member moves in a second direction away from the skin target.

82. A tissue penetrating system comprising:

an electromechanical penetrating member driver;

a plurality of penetrating members each having a sharpened distal tip;

a plurality of cartridges each associated with a penetrating member and coupled to the penetrating member driver, each cartridge having a plurality of seals for maintaining the distal tip of the penetrating member in a sterile condition prior to launch; and

a tissue stabilizing member coupled to at least one of the cartridges.

89. A tissue penetrating system, comprising:

a penetrating member driver having penetrating member position feedback control;

a plurality of penetrating members each having a sharpened distal tip;

a plurality of cartridges each associated with a penetrating member and coupled to the penetrating member driver, each cartridge having a plurality of seals for maintaining the distal tip of the penetrating member in a sterile condition prior to lancing; and

a tissue stabilizing member coupled to at least one of the cartridges.

96. A tissue penetrating system, comprising:

a penetrating member driver having penetrating member position feedback control;

a plurality of penetrating members each having a sharpened distal tip;

a plurality of cartridges, each associated with a penetrating member and coupled to the penetrating member driver, each cartridge having a plurality of seals for maintaining the distal tip of the penetrating member in a sterile condition prior to lancing;

a cartridge transport device for moving each of the cartridges to a position aligning the penetrating member with the penetrating member driver so that the penetrating member may be driven along a path into the tissue site; and

a tissue stabilizing member coupled to at least one of the cartridges.