Method and apparatus for a multi-use body fluid sampling device with sterility barrier release

• US 20040049220A1
• Filed: 12/18/2002
• Published: 03/11/2004
• Est. Priority Date: 04/19/2002
• Status: Active Grant

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Pelikan Technologies, Inc.
• Inventors: Boecker, Dirk, Alden, Don, Schumann, Matt, Cane, Michael, Beadman, Michael, Wittig, Michael
• Granted Patent: US 7,226,461 B2
• Time in Patent Office: Days
• US Class Current: 606/181
• 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 with a gripper is provided. A cartridge is provided that defines a plurality of cavities. A plurality of penetrating members are at least partially contained in the cavities of the cartridge. The penetrating members are slidably movable to extend outward from the cartridge to penetrate tissue. Each cavity has a longitudinal opening that provides access to an elongate portion of the penetrating member. A sterility barrier is coupled to the cartridge. The sterility barrier covers a plurality of the longitudinal openings. The sterility barrier is configured to be moved so that the elongate portion is accessed by the gripper without touching the barrier.

Claims

1. A device for use with a gripper, the device comprising:

a cartridge defining a plurality of cavities; and

a plurality of penetrating members at least partially contained in said cavities of the 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, wherein the sterility barrier covering the lateral openings is configured to be moved so that the elongate portion may be accessed by the gripper without touching the barrier.

2. The device of claim 1 wherein said cartridge includes at least one narrowed portion creating a frictional coupling with one of the penetrating members.

3. The device of claim 1 wherein each of said cavities further include a lateral opening.

4. 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 and each of said penetrating members being moveable relative to the other ones of the penetrating members, so that the distal end of the respective penetrating member is movable to penetrate tissue;

wherein each of said penetrating member is a bare lancet does not penetrate an outer sterility barrier during actuation.

5. A device comprising:

a cartridge having 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, wherein the sterility barrier covering the lateral openings is configured to be moved so that a penetrating member exits the lateral opening without contacting the barrier.

6. The device of claim 5 wherein the sterility barrier covering the lateral openings is configured to be moved substantially vertically so that a penetrating member exits the lateral opening without contacting the barrier.

7. The device of claim 5 wherein the sterility barrier covering the lateral openings is configured to be punched downward so that a penetrating member exits the lateral opening without contacting the barrier.

8. The device of claim 5 wherein the sterility barrier covering the lateral openings at least partially breaks away so that a penetrating member exits the lateral opening without contacting the barrier.

9. The device of claim 5 wherein the sterility barrier is positioned to define a surface at an angle between about 3 degrees and 90 degrees, relative to horizontal.

10. The device of claim 5 wherein the sterility barrier is postioned to define a surface at an angle of about 45 degrees, relative to horizontal.

11. The device of claim 5 wherein the sterility barrier is made of a material containing one of the following:

aluminum, polymer, and paper.

12. The device of claim 5 wherein the sterility barrier is made of a laminate made from one of the following:

aluminum, polymer, and paper.

13. The device of claim 5 wherein said cartridge includes at least one narrowed portion creating a frictional coupling with one of the penetrating members.

14. The device of claim 5 wherein said cartridge includes at least one narrowed portion near a sharpened end of each of said penetrating members, said narrowed portion acting as a guide for the penetrating member during actuation.

15. The device of claim 5 wherein said cartridge includes a plurality of indentations for assisting in cartridge indexing.

16. The device of claim 5 wherein said cartridge includes a plurality of indentations substantially adjacent an inner radial surface of the cartridge for assisting in cartridge indexing.

17. The device of claim 5 wherein said cartridge includes a plurality of indentations on the cartridge for assisting in cartridge indexing, wherein the indentations are not located on an outer peripheral surface of the cartridge.

18. The device of claim 5 wherein said cartridge includes a plurality of notches positioned to gather excess material from the sterility barrier.

19. The device of claim 5 wherein said plurality of penetrating members have sharpened tips pointed radially inward and said members are movable radially inward to penetrate tissue.

20. The device of claim 5 wherein the cartridge has a flat radial configuration.

21. The device of claim 5 wherein the cartridge includes at least a portion having a conical configuration.

22. The device of claim 5 having at least one empty cavity for receiving a penetrating member gripper when the cartridge is loaded.

23. The device of claim 5 wherein said plurality of penetrating members are substantially in a common plane.

24. The device of claim 5 wherein said plurality of penetrating members are bare lancets.

25. The device of claim 5 wherein said plurality of penetrating members each includes at least one notch to facilitate handling.

26. The device of claim 5 wherein said plurality of penetrating members includes at least one bent lancet.

27. The device of claim 5 wherein said cavity includes an indentation for receiving a penetrating member gripper.

28. The device of claim 5 wherein each penetrating member rests on a protrusion in the cavity, said protrusion configured to facilitate engagement of the penetrating member with a slot on a penetrating member gripper.

29. A device comprising means for housing a plurality of penetrating members in a radial configuration, said penetrating members individually couplable to a driver.

30. A lancing system 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 at least one of said lateral openings and configured to be moved so that a penetrating member exiting the lateral opening during actuation will not contact the barrier;

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

31. A lancing system 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 at least one of said lateral openings and configured to be moved so that a penetrating member exiting the lateral opening during actuation will not contact the barrier;

a feedback loop for controlling trajectory of each of said penetrating members extending outward from the cartridge during actuation.

32. A lancing system comprising:

a single cartridge having a plurality of cavities;

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;

a punch movable to penetrate the sterility barrier and release one of the penetrating members from a sterile environment created by the sterility barrier.

33. The system of claim 32 wherein the punch is positioned to penetrate the sterility barrier of a cavity adjacent an active cavity.

34. The system of claim 32 wherein the punch is positioned to penetrate the sterility barrier of a cavity that is not an active cavity.

35. The system of claim 32 wherein the punch moves vertically when urged by a cam surface.

36. The system of claim 32 wherein the cartridge moves vertically when urged by a cam surface.

37. The system of claim 32 further comprising a cam having a radial configuration for urging the motion of the punch.

38. The system of claim 32 further comprising a cam having a radial configuration for urging the motion of a cartridge pusher which in turn moves the cartridge.

39. The system of claim 32 further comprising a ratchet mechanism preventing a cam urging the motion of the punch from moving in reverse.

40. The system of claim 32 further comprising a mechanical slider actuated by a user, said slider configured to actuate a cam that urges the motion of the punch.

41. The system of claim 32 further comprising an electrically powered force generator for actuating an active one of said penetrating members.

42. The system of claim 32 further comprising:

an electrically powered force generator for actuating an active one of said penetrating members;

a position sensor coupled to said force generator used to determine position of an active one of said penetrating members.

43. A lancing system comprising:

a single cartridge having a plurality of cavities;

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;

a punch movable to penetrate the sterility barrier, pushing the sterility barrier into a position so that the penetrating member may be actuated without contacting the sterility barrier.

44. A device comprising:

a single cartridge;

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

a plurality of openings on said cartridge configured to position said cartridge to align an unused penetrating member with the driver.

an actuator configured to engage the openings and actuate the cartridge to move said unused penetrating member into alignment with the driver.

45. The device of claim 44 wherein said plurality of openings are adjacent an inner radial surface of the cartridge.

46. The device of claim 44 wherein said plurality of openings are located on an underside of the cartridge.

47. The device of claim 44 wherein said actuator is electrically powered.

48. The device of claim 44 wherein said actuator is coupled to a mechanical slider actuated by a user.

49. The device of claim 44 wherein said actuator moves horizontally to index the cartridge.

50. A lancing system comprising:

a driver;

a cartridge;

a plurality of bare lancets coupled to cartridge;

a lancet gripper coupled to the driver, wherein the gripper has a slot for receiving at least one of the bare lancets, said slot creating a frictional grip with said one of the bare lancets.

51. The system of claim 50 wherein the gripper has leg portions defining said slot, said legs movable elastically to receive the bare lancet.

52. The system of claim 50 wherein the gripper has a tuning fork shaped configuration.

53. The system of claim 50 wherein the gripper moves vertically relative to the lancet to engage an elongate portion of the lancet.

54. The system of claim 50 a gripper block for coupling the gripper to a driver.

55. A lancing system comprising:

a lancet driver;

a plurality of lancets in a disc-shaped housing;

a lancet gripper;

a lancet release device for releasing the lancet for a sterile environment prior to use; and

an actuator configured to move the disc-shaped housing relative to the lancet gripper to bring one of said lancets into contact with the lancet gripper.

56. A lancing system as in claim 55 wherein the lancet release device includes a punch with sufficient sharpness to penetrate a sterility barrier enclosing a cavity containing said lancet.

57. A lancing system as in claim 55 wherein the lancet release device includes a punch with sufficient sharpness to penetrate a sterility barrier enclosing a cavity containing said lancet and shaped to urge the barrier towards the sides of the cavity.

58. A lancing system as in claim 55 wherein the lancet release device includes a punch having a first portion for piercing one location of the sterility barrier and a second portion for opening a second location of the sterility barrier.

59. The system of claim 55 wherein said lancet driver is an electric powered driver.

60. The system of claim 55 wherein said release device comprises a movable member sufficient to pierce a lancet enclosure.

61. The system of claim 55 further comprising a lancet coupler suitable for engaging one of the lancets and independently advancing one of the lancets along a path outward from the housing, into a target tissue, and back into the housing.

62. The system of claim 55 further comprising a lancet coupler suitable for engaging one of the modules and advancing one of the modules and one of the lancets such that said one of the lances advances along a path outward from the housing, into a target tissue, and back into the housing.

63. A lancing system comprising:

a lancet driver;

a cartridge housing said plurality of lancets;

a lancet gripper coupled to said lancet driver;

a lancet release device releasing one of the lancets from a sterile environment prior to use;

said cartridge being movable relative to the lancet driver to engage and disengage one of said lancets from the lancet gripper.

64. The system of claim 63 wherein said lancet driver and cartridge are in the same plane.

65. The system of claim 63 wherein said cartridge moves vertically relative to the lancet driver.

66. A lancing system for use with a driver, said system comprising:

[CAM/PUNCH]

means for releasing a penetrating member from a sterile enclosure on a cartridge, said cartridge having a plurality of sterile enclosures and a plurality of penetrating members;

means for aligning and operatively coupling said penetrating member to said driver.

67. A method comprising:

loading a cartridge having a plurality of penetrating members into a housing of a lancing apparatus;

releasing said penetrating member from a sterilized environment on the cartridge;

transporting said penetrating member within the housing towards a launch position;

loading said lancet to be operatively coupled to a penetrating member driver in the apparatus.

68. The method of claim 67 wherein said releasing of said penetrating member comprises using a punch to penetrate a sterility barrier of a cavity adjacent a cavity in the launch position.

69. The method of claim 67 wherein said transporting comprises rotating said cartridge to move said cavity with the released penetrating member into the launch position.

70. The method of claim 67 wherein loading comprises creating a frictional coupling between the penetrating member and the driver.

71. The method of claim 67 wherein loading comprises moving the cartridge relative to the driver to bring the driver into contact with the released penetrating member.

72. A method comprising:

providing a cartridge having a plurality of individually sealed cavities each containing a penetrating member;

lowering a punch plate to release an unused penetrating member from one of the sealed cavities;

rotating the cartridge to align the unused penetrating member with a gripper;

creating a frictional engagement with the penetrating member by inserting the penetrating member into a receiving slot on the gripper.

73. A method comprising:

providing a cartridge having a plurality of cavities each containing a penetrating member, wherein each member is held by a coupling to the cartridge;

engaging a penetrating member with a gripper;

using a first force generator to move the gripper in a manner sufficient to release the penetrating member from the coupling to the cartridge;

using a second force generator to move the gripper in a manner sufficient to drive the penetrating member into tissue.

74. A method comprising:

providing a cartridge having a plurality of cavities each containing a penetrating member, wherein each member is held by a coupling to the cartridge;

providing a punch device;

providing a penetrating member gripper;

creating relative motion between the cartridge and the gripper wherein the cartridge is separated from the gripper;

creating relative motion between the cartridge and the gripper wherein the gripper is aligned over an unused penetrating member in the cartridge;

creating relative motion between the cartridge and the gripper wherein the gripper is engaged with the unused penetrating member.

75. A method comprising:

providing a lancet driver;

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

lancing performance or lancing setting.

76. A method comprising:

providing a cartridge having a plurality of cavities;

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

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

77. 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 a plurality of penetrating members;

using a planar sheet of sterility barrier material to cover a plurality of said cavities to create a sterile environment inside each of said cavities.

78. A method comprising:

providing a cartridge having a plurality of bare lancets;

moving at least a portion of a sterility barrier such that an active one of said bare lancets exits the cartridge to penetrate tissue without contacting said sterility barrier;

retracting said active one of said bare lancets back into the cartridge after penetrating tissue.

79. The method of claim 78 wherein said moving comprises using a punch to break off at least a portion of the sterility barrier.

80. The method of claim 78 wherein said moving comprises moving a punch vertically to penetrate the sterility barrier.

81. The method of claim 78 further comprising moving said cartridge to align the released bare lancet with a lancet gripper.

82. The method of claim 78 further comprising using a cam surface to move a punch to penetrate the sterility barrier.

83. The method of claim 78 further comprising having a patient move a mechanical slider to actuate a cam surface that moves a punch to penetrate the sterility barrier.