Method and apparatus for body fluid sampling and analyte sensing

• US 20070100255A1
• Filed: 05/28/2004
• Published: 05/03/2007
• Est. Priority Date: 04/19/2002
• Status: Abandoned Application

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Pelikan Technologies, Inc.
• Inventors: Boecker, Dirk, Alden, Don, Freeman, Dominique, Schumann, Matt, Beadman, Michael
• Application Number:
  US10/558,976
• Publication Number:
  US 20070100255A1
• Time in Patent Office: Days
• US Class Current: 600/583
• 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 5/150152 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 5/150358 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 5/15146 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 5/15161 Characterized by propelling the piercing element in a radial 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 5/157 Devices characterised by integrated means for measuring characteristics of blood

Abstract

A body fluid sampling system is provided for use on a tissue site. In one embodiment, the system comprises a cartridge; a penetrating member driver; a plurality of penetrating members arranged in a radial configuration on the cartridge wherein sharpened distal tips of the penetrating members point radially outward; wherein an active one of the penetrating members may be operatively coupled to the penetrating member driver, the penetrating member driver moving the active one along a path out of a housing having a penetrating member exit, into the tissue site, stopping in the tissue site, and withdrawing out of the tissue site; and a plurality of analyte detecting members, wherein at least one of the analyte detecting members is positioned to receive fluid from a wound created by the active one of the penetrating members, wherein the detecting members are not pierced by the active one of the penetrating members.

Claims

1. (canceled)

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

a cartridge;

a penetrating member driver;

a plurality of penetrating members arranged in a radial configuration on the cartridge wherein sharpened distal tips of the penetrating members point radially outward;

wherein an active one of said penetrating members may be operatively coupled to said penetrating member driver, said penetrating member driver moving said active one 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; and

a plurality of analyte detecting members, wherein at least one of said analyte detecting members is positioned to receive fluid from a wound created by said active one of said penetrating members, wherein said detecting members are not pierced by the active one of the penetrating members.

3. A system as in claim 2 wherein at least one of said detecting members is mounted about a penetrating member exit.

4. A system as in claim 2 wherein said detecting member is not pierced by the penetrating member and is within 2 mm of a front end of the housing.

5. A system as in claim 2 wherein said cartridge has a plurality of penetrating member exits, and wherein at least one of said detecting members is mounted about each of said penetrating member exits.

6. A system as in claim 2 wherein said analyte detecting members comprise test strips.

7. A system as in claim 2 wherein said analyte detecting members are housing a second cartridge.

8. A system as in claim 7 wherein the second cartridge is integrated with the cartridge housing the penetrating members.

9. A system as in claim 7 wherein the second cartridge may rotate relative to the penetrating member driver.

10. A system as in claim 2 wherein detecting members are mounted in a radial configuration on said cartridge.

11. A system as in claim 2 wherein said penetrating member driver comprises a spring based launching device.

12. A system as in claim 2 wherein said analyte detecting member comprises a test strip individually movable relative to said housing.

13. A system as in claim 2 wherein said detecting member is configured to determine a concentration of an analyte in the fluid using a sample of less than 1 μ

l of the fluid.

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

15. The system of claim 14, wherein the depth of penetration is about 100 to 2500 microns.

16. The system of claim 14, wherein the depth of penetration is 500 to 750 microns.

17. The system of claim 14, wherein the depth of penetration is no more than about 1000 microns beyond a stratum corneum thickness of a skin surface.

18. The system of claim 14, wherein the depth of penetration is no more than about 500 microns beyond a stratum corneum thickness of a skin surface.

19. The system of claim 14, wherein the penetrating member sensor is further configured to provide an indication of velocity of a penetrating member.

20. The system of claim 2, wherein one of said analyte detecting members is movable outward towards said wound to more easily engage said fluid.

21. The system of claim 2, wherein said analyte detecting members are individually actuatable to extend outward from said housing.

22. The system of claim 2, wherein the driver is selected from one of the following:

a voice coil, a rotary voice coil, a solenoid, a motor and gear box, a nanomuscle, or a combination of any of the above.

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

24. The system of claim 23, wherein the processor includes a memory for storage and retrieval of a set of penetrating member profiles utilized with the penetrating member driver.

25. The system of claim 23, wherein the processor is utilized to monitor position and speed of a penetrating member as the penetrating member moves in a first direction.

26. The system of claim 23, wherein the processor is utilized to adjust an application of force to a penetrating member to achieve a desired speed of the penetrating member.

27. The system of claim 23, 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.

28. The system of claim 23, 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.

29. The system of claim 28, 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.

30. The system of claim 29, 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.

31. The system of claim 29, 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.

32. The system of claim 28, wherein a speed of a penetrating member in the first direction is the range of about 2.0 to 10.0 m/sec.

33. The system of claim 28, wherein a speed of a penetrating member in the first direction is the range of 1.0 to 10.0 m/sec.

34. The system of claim 28, wherein a speed of a penetrating member in the first direction is the range of 3.0 to 8.0 m/sec.

35. The system of claim 28, 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.

36. The system of claim 2, 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.

37. The system of claim 2, 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.

38. The system of claim 29, 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.

39. The system of claim 14, wherein the penetrating member sensor is selected from one of the following:

a capacitive incremental encoder, an incremental encoder, an optical encoder, or interference encoder.

40. The system of claim 2 further comprising a plurality of analyte detecting members positioned to receive body fluid from said wound.

41. The system of claim 2, 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 about 1.0 μ

l of the body fluid.

42. The system of claim 2, 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 about 0.75 μ

l of the body fluid.

43. The system of claim 2, 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 about 0.5 μ

l of the body fluid.

44. The system of claim 2, 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 about 0.25 μ

l of the body fluid.

45. The system of claim 2, 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 about 0.1 μ

l of the body fluid.

46. The system of claim 2, 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 about 1 μ

l of a body fluid disposed in the sample chamber.

47. The system of claim 2, 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 about 0.75 μ

l of a body fluid disposed in the sample chamber.

48. The system of claim 2, 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 about 0.5 μ

l of a body fluid disposed in the sample chamber.

49. The system of claim 2, 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 about 0.25 μ

l of a body fluid disposed in the sample chamber.

50. The system of claim 2, 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 about 0.1 μ

l of a body fluid disposed in the sample chamber.

51. The system of claim 2, further comprising:

a tissue stabilizer device coupled to the housing.

52. The system of claim 51, wherein the tissue stabilizer device applies a vacuum to a target tissue.

53. The system of claim 51, 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.

54. The system of claim 2, further comprising:

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

55. The system of claim 51, further comprising

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

56. The system of claim 51, further comprising

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

57. The system of claim 2 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.

58. The system of claim 2, wherein each penetrating member each penetrating members is an elongate member without molded attachments.

59. The system of claim 2, wherein each penetrating member each penetrating members comprises a needle having a lumen therein.

60. The system of claim 2, wherein each penetrating member each penetrating members comprises a microneedle having a lumen therein.

61. The system of claim 2 further comprising a resilient member coupled to said penetrating member, said penetrating member driver aligned to move said resilient member which in turn moves the penetrating member.

62. The system of claim 2 wherein:

the penetrating member comprises a spring based device and at one of the following;

a motor and gear box, a nanomuscle, pneumatic device, a liquid magnetic coil actuation device, a stepper motor, a micro-clutch device, and an inductive motor.

63. The system of claim 2 wherein the penetrating member exit is configured to be positioned against the tissue when the penetrating member contacts the tissue.

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

a cartridge;

a penetrating member driver;

a plurality of penetrating members, each having a proximal end, an elongate portion, and a sharpened distal end, said members arranged in a radial configuration on the cartridge wherein sharpened distal tips of the penetrating members point radially outward;

wherein an active one of said penetrating members may be operatively coupled to said penetrating member driver, said penetrating member driver moving said active one 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; and

a plurality of analyte detecting members, wherein at least one of said analyte detecting members is positioned to receive fluid from a wound created by said active one of said penetrating members;

wherein said unused analyte detecting members are arranged in a stack.

said penetrating member driver configured to be controlled to follow a velocity trajectory into the tissue and out of said tissue, wherein said velocity into said tissue is at an average speed greater than an average speed of the penetrating member on the withdrawal.

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

a cartridge;

a penetrating member driver;

a plurality of penetrating members arranged in a radial configuration on the cartridge wherein sharpened distal tips of the penetrating members point radially outward;

wherein an active one of said penetrating members may be operatively coupled to said penetrating member driver, said penetrating member driver moving said active one 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; and

a plurality of analyte detecting members, wherein at least one of said analyte detecting members is positioned to receive fluid from a wound created by said active one of said penetrating members, wherein said detecting members are not pierced by the active one of the penetrating members;

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

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

a cartridge;

a penetrating member driver;

a plurality of penetrating members arranged in a radial configuration on the cartridge wherein sharpened distal tips of the penetrating members point radially outward;

wherein an active one of said penetrating members may be operatively coupled to said penetrating member driver, said penetrating member driver moving said active one 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; and

a plurality of analyte detecting members, wherein at least one of said analyte detecting members is positioned to receive fluid from a wound created by said active one of said penetrating members, wherein said detecting members are not pierced by the active one of the penetrating members;

a coupler on said penetrating member driver 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.

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

a cartridge;

a penetrating member driver;

a plurality of penetrating members arranged in a radial configuration on the cartridge wherein sharpened distal tips of the penetrating members point radially outward;

wherein an active one of said penetrating members may be operatively coupled to said penetrating member driver, said penetrating member driver moving said active one 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; and

a plurality of analyte detecting members, wherein at least one of said analyte detecting members is positioned to receive fluid from a wound created by said active one of said penetrating members, wherein said detecting members are not pierced by the active one of the penetrating members;

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

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

a cartridge;

a penetrating member driver;

a plurality of penetrating members arranged in a radial configuration on the cartridge wherein sharpened distal tips of the penetrating members point radially outward;

wherein an active one of said penetrating members may be operatively coupled to said penetrating member driver, said penetrating member driver moving said active one 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; and

a plurality of analyte detecting members, wherein at least one of said analyte detecting members is positioned to receive fluid from a wound created by said active one of said penetrating members, wherein said detecting members are not pierced by the active one of the penetrating members;

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

69. A body fluid sampling device using a penetrating member to extract fluid from an anatomical feature, said device comprising:

a penetrating member actuator for moving the penetrating member inbound towards the anatomical feature; and

a non-spring based, penetrating member retractor for moving said penetrating member outbound away from the anatomical feature;

wherein said penetrating member actuator is adapted to move said penetrating member at a velocity greater than a velocity achieved by the penetrating member retractor.

70. The device of claim 69 wherein the penetrating member actuator uses a spring to move said penetrating member.

71. The device of claim 69 wherein the penetrating member retractor uses one of the following to move said penetrating member:

a motor and gear box, a nanomuscle, pneumatic device, a liquid magnetic coil actuation, a stepper motor, a micro-clutch device, and an inductive motor.

72. The device of claim 69 further comprising a plurality of penetrating members arranged in a radial configuration.

73. The device of claim 69 further comprising a plurality of penetrating members arranged in a radial configuration on a disc, with distal tips of said penetrating members pointed radially outward.

74. The device of claim 69 wherein said penetrating member actuator include a gripper block shaped to extend into a cartridge containing said penetrating member in order to engage said penetrating member.

75. The device of claim 69 wherein said penetrating member actuator includes a portion for breaking a seal on a cartridge containing said penetrating members, said portion breaking said seal to allow the actuator to engage the penetrating member.

76. The device of claim 69 further comprising at least one guide bearing in said cartridge for providing support in at least one of the following:

lateral guidance or vertical guidance.

77. The device of claim 69 further comprising a slidable cutter for removing a seal on a cartridge prior to penetrating member actuation.

78. The device of claim 69 further comprising a damper coupled to a coupler attaching the penetrating member to a penetrating member actuator.

79. The device of claim 69 further comprising a damper for slowing said penetrating member prior to said penetrating member reaching a hard stop.

80. The device of claim 69 further comprising a damper coupled to a drive shaft of the penetrating member actuator.

81. The device of claim 69 further comprising a damper for slowing the penetrating member on the inbound direction, said damper selected from one of the following:

a pneumatic damper, a fluid piston, a rubber stop, a frictional surface, a magnetic fluid based damper, or a rheonetic fluid based damper.

82. The device of claim 69 further comprising an optically reflective member coupled to a drive shaft of the penetrating member actuator, said optically reflective member used for determining the positioning.

83. The device of claim 69 further comprising a penetrating member coupler attached to the actuator and the retractor.

84. The device of claim 69 further comprising a cartridge containing a plurality of penetrating members.

85. The device of claim 69 further comprising a cartridge containing a plurality of penetrating members.

86. The device of claim 69 further comprising a drive shaft coupled to the penetrating member actuator and a penetrating member coupler.

87. The device of claim 69 further comprising a carrier coupled to said retractor and movable between a first position and a second position, said penetrating member actuator mounted on the carrier and movable with the carrier.

88. The device of claim 69 further comprising a friction damper having a plunger, said damper having a lumen with a funnel shaped portion and an elongate portion, said plunger sized to engage said elongate portion to provide damping.

89. The device of claim 69 further comprising a friction damper on said carrier for slowing said penetrating member, said friction damper shaped to provide variable resistance based on the position of a penetrating member coupler.

90. The device of claim 69 further comprising a reset latch coupled to said carrier, said reset latch holding a penetrating member coupler in place while the drive is compressed.

91. A body fluid sampling device for extracting bodily fluid from an anatomical feature, said device comprising:

a cartridge having a plurality of cavities;

a plurality of penetrating members, each slidably movable between a first position and a second position to extend outward from said cartridge to penetrate the anatomical feature; and

a penetrating member driver structured to selectively and independently engage said penetrating members, said driver comprising a first resilient member for moving an active one of the penetrating members on an inbound path toward the anatomical feature to create a wound, and a second resilient member for moving the active one of the penetrating members on an outbound path away from the wound.

92. The device of claim 91 wherein said cartridge is disc shaped.

93. The device of claim 91 wherein the first resilient member comprises a spring.

94. The device of claim 91 wherein the second resilient member comprises a spring.

95. The device of claim 91 further comprising a damper coupled to said penetrating member driver.

96. The device of claim 91 further comprising a plurality of sample chambers on said cartridge.

97. The device of claim 95 wherein said sample chamber is sized to hold no more than 1 microliter.

98. A body fluid sampling device using a penetrating member to extract fluid from an anatomical feature, said device comprising:

a penetrating member driver, said driver selected from one of the following;

a motor and gear box, a nanomuscle, pneumatic device, a liquid magnetic coil actuation device, a stepper motor, a micro-clutch device, and an inductive motor;

a penetrating coupler attached to said driver, said coupler for releasably connecting the penetrating member to the driver.