Method and apparatus for a multi-use body fluid sampling device

• US 20040102803A1
• Filed: 12/18/2002
• Published: 05/27/2004
• Est. Priority Date: 04/19/2002
• Status: Active Grant

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Pelikan Technologies, Inc.
• Inventors: Boecker, Dirk, Freeman, Dominique M., Wittig, Michael
• Granted Patent: US 7,708,701 B2
• Time in Patent Office: Days
• US Class Current: 606/183
• 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 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• 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 5/150358 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 5/150519 Details of construction of hub, i.e. element used to attach the single-ended needle to a piercing device or sampling device
• CPC Class Codes: A61B 5/150572 Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
• CPC Class Codes: A61B 5/150664 Pivotable protective sleeves, i.e. sleeves connected to, or integrated in, the piercing or driving device, and which are pivoted for covering or uncovering the piercing element
• 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 5/150916 : by blocking components, e.g. piston, driving device or fluid passageway
• 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 5/15117 : 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 5/1513 : comprising linear sliding guides comprising tooth-shaped elements A61B5/15132
• 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 5/15161 : Characterized by propelling the piercing element in a radial direction relative to the disc
• 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 5/15182 : Means for keeping track or checking of the total number of piercing elements already used or the number of piercing elements still remaining in the stocking, e.g. by check window, counter, display
• CPC Class Codes: A61B 5/15184 : Piercing device comprising a separate compartment or unit for used piercing elements separate compartments for used piercing elements in stocking means A61B5/15178
• CPC Class Codes: A61B 5/15186 : Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use
• CPC Class Codes: A61B 5/157 : Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61M 37/0015 : by using microneedles

Abstract

A device for use in penetrating tissue to obtain a body fluid sample is provided. A cartridge may be included. A plurality of penetrating members are slidably coupled to the cartridge. Each penetrating member has a distal end that is sufficiently sharp to pierce tissue. Each penetrating member may be moveable relative to the other ones of the penetrating members so that the sharpened distal ends extend radially outward to penetrate tissue. The penetrating members are elongate members without molded attachments.

Claims

1. A device for use in penetrating tissue to obtain a body fluid sample, comprising:

a cartridge; and

a plurality of penetrating members slidably coupled to the cartridge, each of said penetrating members having a distal end sufficiently sharp to pierce tissue, each of said penetrating members being moveable relative to the other ones of the penetrating members so that the sharpened distal ends extend radially outward to penetrate tissue;

wherein said penetrating members are elongate members without molded attachments.

2. The device of claim 1 wherein said cartridge defines a plane and said penetrating members are contained in substantially the same plane.

3. The device of claim 1 wherein said cartridge defines a plane and said penetrating members are oriented to extend radially outward in substantially the same plane as the cartridge.

4. The device of claim 1 wherein said penetrating members are substantially in a common plane.

5. The device of claim 1 wherein said penetrating members are arranged in a radial pattern.

6. The device of claim 1 wherein said penetrating members have notches on their surface.

7. The device of claim 1 wherein said penetrating members are coated with a material.

8. The device of claim 1 wherein said penetrating members are coated with a material selected from the following:

Teflon, glass, silicon, or polymer.

9. The device of claim 1 wherein cartridge has a flat radial configuration.

10. The device of claim 1 further comprising a sterility barrier coupled to said cartridge.

11. The device of claim 1 wherein said cartridge comprises a disc-shaped housing.

12. The device of claim 1 wherein said cartridge has a plurality of cavities housing said lancets.

13. The device of claim 1 wherein said cartridge has a plurality of grooves housing said lancets.

14. The device of claim 1 further comprising a plurality of ratchet surfaces near an inner radial surface of the cartridge.

15. The device of claim 1 wherein said cartridge comprises a disc-shaped housing with a non-chamfered outer periphery.

16. A device for use in penetrating tissue to obtain a body fluid sample, comprising:

a cartridge having a plurality of cavities; and

a plurality of bare lancets having sharpened tips and slidably coupled to the cartridge, each of said bare lancets being moveable relative to the other ones of the bare lancets along a path out of the cartridge to penetrate tissue;

said bare lancets arranged with said sharpened tips pointing radially outward;

wherein each of said cavities is defined in part by a deflectable portion, wherein said deflectable portion in a first position prevents said penetrating member from exiting the cartridge and said deflectable portion is movable to a second position creating an opening that allows said lancet to extend outward from the cartridge.

17. The device of claim 16 wherein said portion is vertically deflectable.

18. The device of claim 16 wherein said portion is horizontally deflectable.

19. The device of claim 16 further comprising a sterility barrier over a planar surface of the cartridge covering a plurality of longitudinal openings on the surface.

20. The device of claim 16 wherein each deflectable portion includes a penetrable wall for receiving a sharpened tip of a used penetrating member.

21. A device for use in penetrating tissue to obtain a body fluid sample, comprising:

a cartridge having a plurality of cavities; and

a plurality of penetrating member slidably coupled to the cartridge, each of said penetrating members at least partially housed in one of said cavities and being moveable relative to the other ones of the penetrating members along a path out of the cartridge and into tissue;

a sterility barrier covering a plurality of openings on said cartridge and creating a sterile environment in the plurality of cavities.

22. The device of claim 21 wherein said cartridge is a unitary body.

23. The device of claim 21 wherein said sterility barrier comprises a metallic foil.

24. The device of claim 21 wherein said penetrating members are each a unitary body without plastic molded attachments.

27. The device of claim 21 wherein said cartridge has a flat radial configuration.

28. The device of claim 21 wherein said second barrier covers a bottom surface of the cartridge.

29. The device of claim 21 wherein said second barrier covers a side surface of the cartridge.

25. A device comprising:

a single radial cartridge;

a plurality of bare lancets slidably coupled to said cartridge and selectively actuatable to penetrate tissue, each of said lancets having an longitudinal axis;

wherein the lancets are longitudinally oriented to be substantially in a common plane.

26. A device comprising:

a cartridge;

a plurality of bare lancets slidably coupled to said cartridge and selectively actuatable to penetrate tissue, each of said lancets having an longitudinal axis;

a first sterility barrier on a top surface of the cartridge;

a second sterility barrier another surface of the cartridge.

30. An apparatus for penetrating an organism comprising:

a penetrating member;

a first surface in physical contact with the penetrating member;

a second surface in physical contact with the penetrating member;

wherein the friction coefficient between the penetrating member and the second surface is at least 15% less than the friction coefficient between the penetrating member and the first surface.

31. The apparatus of claim 30, wherein the friction coefficient between the penetrating member and the second surface is at least half the friction coefficient between the penetrating member and the first surface.

32. The apparatus of claim 30, wherein the friction coefficient between the penetrating member and the second surface is at least one-quarter the friction coefficient between the penetrating member and the first surface.

33. The apparatus of claim 30, wherein the friction coefficient between the penetrating member and the second surface is at least one-tenth the friction coefficient between the penetrating member and the first surface.

34. The apparatus of claim 30, further comprising a driver coupled to the first surface configured to drive the first surface and penetrating member along a longitudinal axis of the penetrating member.

35. A lancing device, comprising a penetrating member having a shaft with a transverse slot configured to mate to a protuberance of a drive member.

36. A penetrating member, comprising a shaft having a friction enhanced outer surface.

37. A device comprising:

a cartridge defining a plurality of cavities; and

a plurality of penetrating members at least partially contained in said cavities of the single cartridge wherein the penetrating members are slidably movable to extend outward from said cartridge to penetrate tissue, said cavities each having a longitudinal opening providing access to an elongate portion of the penetrating member;

a sterility barrier coupled to said cartridge, said sterility barrier covering a plurality of the longitudinal openings.

38. A device comprising:

a cartridge defining a plurality of cavities; and

a plurality of penetrating members at least partially contained in said cavities of the single cartridge wherein the penetrating members are slidably movable to extend outward from lateral openings on said cartridge to penetrate tissue;

a sterility barrier coupled to said cartridge, said sterility barrier covering a plurality of said lateral openings.

39. A lancing system comprising:

a cartridge;

a plurality of penetrating members coupled to said cartridge and selectively actuatable to penetrate tissue, said penetrating members extending radially outward to penetrate tissue;

an electrically powered drive force generator operatively coupled to an active penetrating member to drive said penetrating member into a tissue site.

40. A system as in claim 39 further comprising a penetrating member coupler attached the drive force generator, the coupler configured to establish a frictional coupling with an active one of said penetrating members.

41. A system as in claim 39 further comprising means for moving said a penetrating member into contact with an active of said.

42. A system as in claim 39 wherein said penetrating member coupler is vertically movable.

43. A system as in claim 39 further comprising an actuator for rotating said radial cartridge.

44. A system as in claim 39 further comprising means for coupling with an active one of said penetrating members.

45. A system as in claim 39 further comprising a penetrating member sensor positioned to monitor an active one of said penetrating members, the penetrating member sensor configured to provide information relative to a depth of penetration of a penetrating member through a skin surface.

46. The system of claim 45, wherein the depth of penetration is 100 to 2500 microns.

47. The system of claim 45, wherein the depth of penetration is 500 to 750 microns.

48. The system of claim 45, wherein the depth of penetration is no more than about 1000 microns beyond a stratum corneum thickness of a skin surface.

49. The system of claim 45, wherein the depth of penetration is no more than about 500 microns beyond a stratum corneum thickness of a skin surface.

50. The system of claim 45, wherein the depth of penetration is no more than about 300 microns beyond a stratum corneum thickness of a skin surface.

51. The system of claim 45, wherein the depth of penetration is less than a sum of a stratum corneum thickness of a skin surface and 400 microns..

52. The system of claim 45, wherein the penetrating member sensor is further configured to control velocity of a penetrating member.

53. The system of claim 39, wherein the active penetrating member moves along a substantially linear path into the tissue.

54. The system of claim 39, wherein the active penetrating member moves along an at least partially curved path into the tissue.

55. The system of claim 39, wherein the driver is a voice coil drive force generator.

56. The system of claim 39, wherein the driver is a rotary voice coil drive force generator.

57. The system of claim 45, wherein the penetrating member sensor is coupled to a processor with control instructions for the penetrating member driver.

58. The system of claim 57, wherein the processor includes a memory for storage and retrieval of a set of penetrating member profiles utilized with the penetrating member driver.

59. The system of claim 57, wherein the processor is utilized to monitor position and speed of a penetrating member as the penetrating member moves in a first direction.

60. The system of claim 57, wherein the processor is utilized to adjust an application of force to a penetrating member to achieve a desired speed of the penetrating member.

61. The system of claim 57, 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.

62. The system of claim 57, 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.

63. The system of claim 62, 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.

64. The system of claim 63, 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.

65. The system of claim 63, 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.

66. The system of claim 62, wherein a speed of a penetrating member in the first direction is the range of about 2.0 to 10.0 m/sec.

67. The system of claim 63, 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.

68. The system of claim 45, wherein the penetrating member sensor includes a capacitive incremental encoder.

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

70. The system of claim 45, wherein the penetrating member sensor includes an optical encoder.

71. The system of claim 45, wherein the penetrating member sensor includes an interference encoder.

72. The system of claim 39 wherein said penetrating member is advanced along a path at a velocity following a lancing velocity profile.

73. The system of claim 39 further comprising a user interface configured to relay at least one of, penetrating member performance or a penetrating member setting.

74. The system of claim 73, wherein the user interface is configured to provide a user with at least one input selected from, depth of a penetrating member penetration, velocity of a penetrating member, a desired velocity profile, a velocity of a penetrating member into the target tissue, velocity of the penetrating member out of the target tissue, dwell time of the penetrating member in the target tissue;

tent and hold characteristic of the penetrating member.

75. The system of claim 73, wherein the user interface provides at least one output to the user selected from, number of penetrating members available, number of penetrating members used, actual depth of penetrating member penetration on a target tissue penetrating cycle, stratum corneum thickness, force delivered on a target tissue penetrating cycle, energy used by a penetrating member driver to drive a penetrating member into the target tissue, dwell time of the penetrating member, battery status, system status, consumed energy, and speed profile of the penetrating member during a target tissue penetrating cycle.

76. The system of claim 73, wherein the user interface is selected from at least one of, a visual display selected from:

an LCD, LED, TFT, and a backlit LCD display.

77. The system of claim 73, wherein the user interface includes an input device selected from a button, a touch pad, and a touch sensitive visual display.

78. The system of claim 73, further comprising:

a data exchange device for coupling a penetrating member driver to support equipment.

79. The system of claim 78, wherein the support equipment is selected from at least one of a personal computer, modem, PDA, and a computer network.

80. The system of claim 73, further comprising a data interface configured to couple the skin penetrating system to support equipment with a data interface.

81. The system of claim 80, wherein the data interface is selected from at least one of, Serial RS-232, modem interface, USB, HPNA, Ethernet, optical interface, IRDA, RF interface, Bluetooth interface, cellular telephone interface, 2 way pager interface, parallel port interface standard, near field magnetic coupling, and RF transceiver.

82. The system of claim 73, wherein the user interface includes a real time clock and one or more alarms to provide a user with a reminder of a next target penetrating event is needed.

83. A lancing system comprising:

a cartridge having a opening extending through a center of the cartridge;

a plurality of penetrating members coupled to said cartridge and selectively actuatable to penetrate tissue, said penetrating members extending radially outward to penetrate tissue;

a penetrating member driver at least partially positioned within said central opening, said driver operatively couplable to an active penetrating member to drive said penetrating member into a tissue site.

84. A lancing system comprising:

a single cartridge;

a plurality of penetrating members coupled to said single cartridge and selectively actuatable to penetrate tissue;

an drive force generator operatively coupled to an active penetrating member to drive said penetrating member into a tissue site;

a feedback loop for controlling the position of the active penetrating member coupled to the drive force generator.

85. A lancing system comprising:

a single cartridge;

a plurality of penetrating members coupled to said single cartridge and selectively actuatable to penetrate tissue;

an drive force generator operatively coupled to an active penetrating member to drive said penetrating member into a tissue site;

said drive force generator actuating at least one of said penetrating members to follow a velocity profile.

86. A device comprising:

a single cartridge;

a plurality of penetrating members coupled to said single cartridge and couplable to a penetrating member driver;

a plurality of ratchet surfaces on said cartridge for advancing the cartridge.

87. A device comprising:

a single cartridge;

at least 50 penetrating members coupled to and at least partially housed in said single cartridge wherein said cartridge has a diameter no greater than about 5 inches;

said penetrating members movable in an outward direction from the cartridge to penetrate tissue when actuated by said penetrating member driver.

88. The system of claim 87, wherein the diameter is no great than about 5 cm.

89. The system of claim 87, wherein a volume of the cartridge does not exceed a packing density of about 0.5 cm3/penetrating member.

90. The system of claim 87, wherein a volume of the cartridge does not exceed a packing density of about 0.1 cm3/penetrating member.

91. A device comprising:

a single cartridge;

at least 100 penetrating members coupled to and at least partially housed in said single cartridge wherein said cartridge has a diameter no greater than 6 inches;

[METRIC SIZE?]

said penetrating members movable in an outward direction from the cartridge to penetrate tissue when actuated by said penetrating member driver.

92. The system of claim 91, wherein the diameter is no great than about 5 cm.

93. The system of claim 91, wherein a volume of the cartridge does not exceed a packing density of about 0.5 cm3/penetrating member.

94. The system of claim 91, wherein a volume of the cartridge does not exceed a packing density of about 0.1 cm3/penetrating member.

95. A lancing system comprising:

a plurality of cartridges each including a plurality of penetrating members coupled to the cartridge and couplable to a penetrating member driver;

a cartridge loading device for moving at least one of said cartridges to be operatively coupled to the penetrating member driver.

96. A lancing device comprising:

a penetrating member cartridge wherein penetrating members are retractable and held within the cartridge so that they are not able to be used again.

97. A lancing device comprising:

a cartridge wherein the foil or seal broken by mechanism other than penetrating member.

98. A lancing system for use with a plurality of penetrating members, the lancing system comprising:

a penetrating member driver;

a cartridge housing said plurality of penetrating members;

a penetrating member release device releasing one of the penetrating members from a sterile environment prior to use;

a penetrating member coupling device wherein said cartridge is positionable for one of said penetrating members to engage the coupler to be operatively coupled to said penetrating member driver.

99. A manufacturing method comprising:

providing a cartridge having a plurality of cavities for holding penetrating members;

sealing a plurality of cavities with a seal layer;

providing a plurality of analyte sensors by coupling a sensor layer to the cartridge.

100. A manufacturing method comprising:

providing a cartridge having a plurality of cavities for holding penetrating members;

sterilizing said cartridge while each of said cavities is in a sealed condition and the cartridge contains at least one penetrating member;

applying a sterility barrier to said radial cartridge, said barrier covering a plurality of cavities.

101. A method comprising:

transporting a plurality of penetrating members each in a sterilized environment towards a penetrating member launch position;

releasing one of said penetrating members from a sterilized environment prior to actuation;

moving said penetrating member to the launch position to be operatively coupled to the penetrating member driver.

102. A method comprising:

providing a penetrating member driver;

installing a visual display on said penetrating member driver where said display when coupled to a processor, relays penetrating member information selected from;

lancing performance or lancing setting.

103. A method comprising:

providing a cartridge having a plurality of penetrating members;

penetrating a sterility barrier and moving the barrier clear of a path of an active one of the penetrating members;

forming a frictional coupling with the active one of the penetrating members;

actuating the active one of the penetrating members.

104. A method as in claim further comprising bending a portion of the cartridge to create an opening for said penetrating member to exit the cartridge.

105. A method comprising:

providing a cartridge having a plurality of bare lancets;

forming a frictional coupling with the active one of the bare lancets;

actuating the active one of the penetrating members.