Integrated Sensor for Analyzing Biological Samples

• US 20070149897A1
• Filed: 09/28/2006
• Published: 06/28/2007
• Est. Priority Date: 11/30/2005
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories)
• Inventors: Nicholls, Clive, Ghesquiere, Alexander, Cabrall, John, Matula, Scott
• Granted Patent: US 8,105,244 B2
• Time in Patent Office: Days
• US Class Current: 600/583
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157
• 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 5/150358 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 5/150519 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 5/150564 Protectors removed by pulling or pushing
• CPC Class Codes: A61B 5/150572 Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
• CPC Class Codes: A61B 5/150702 fully automatically removed, i.e. the removing does not require any action by the user
• CPC Class Codes: A61B 5/150786 Optical identification systems, e.g. bar codes, colour codes
• CPC Class Codes: A61B 5/150793 Electrical or magnetic identification means
• CPC Class Codes: A61B 5/15132 comprising tooth-shaped elements, e.g. toothed wheel or rack and pinion
• CPC Class Codes: A61B 5/15153 Multiple piercing elements stocked in a single compartment
• CPC Class Codes: A61B 5/15174 Piercing elements stocked in the form of a stack or pile
• CPC Class Codes: A61B 5/15176 Stocking means comprising cap, cover, sheath or protection for aseptic stocking
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: C12Q 1/006 for glucose
• CPC Class Codes: G01N 33/48757 Test elements dispensed from a stack

Abstract

An integrated lancet and testing striplet for measuring a body analyte level in a health care regimen includes a skin piercing member and an analyte sensor coupled together.

Claims

1. An integrated lancet and testing striplet for measuring a body analyte level in a health care regimen, comprising:

(a) a lancet body including a test strip receiving end and a lancet end;

(b) a lancet needle coupled with, protruding from, and fixed relative to the lancet end of the lancet body,

(c) a test strip coupled to the test strip receiving end of the lancet body having multiple electrodes and assay chemistry for testing a glucose level of an applied body fluid; and

(d) wherein the test strip and lancet needle are relatively disposed at different ends of the striplet for providing both lancing and application of body fluid at a lancing site

2. The integrated lancet and testing striplet of claim 1, wherein the striplet is configured for lancing and application of body fluid at a lancing site by automatically lancing, withdrawing, reorienting and re-advancing the striplet.

3. The integrated lancet and testing striplet of claim 2, wherein the lancet needle and test strip are separated such as not to be in fluid communication with regard to the body fluid.

4. The integrated lancet and testing striplet of claim 3, wherein the lancet needle and test strip are separated sufficiently that test strip is out of reach of spreading analyte prior to withdrawing, re-orienting and re-advancing the striplet.

5. The integrated lancet and testing striplet of claim 2, wherein the reorienting comprises rotating the striplet.

6. The integrated lancet and testing striplet of claim 1, wherein the lancet body comprises a pair of relatively disposed recesses for respectively positioning the test strip for lancing and application of body fluid at said same lancing/testing site.

7. The integrated lancet and testing striplet of claim 6, wherein each of said pair of recesses comprises a substantially trapezoidal shape.

8. The integrated lancet and testing striplet of claim 6, wherein the recesses are configured for coupling with a spring-loaded ball and detent mechanism.

9. The integrated lancet and testing striplet of claim 6, wherein the recesses are configured for coupling with a latching mechanism.

10. The integrated lancet and testing striplet of claim 2, wherein the reorienting comprises flipping approximately 180 degrees.

11. The integrated lancet and testing striplet of claim 1, wherein the test strip and lancet are symmetrically disposed at opposite ends of the lancet body.

12. The integrated lancet and testing striplet of claim 1, further comprising a lancet cap for securing the protruding lancet needle.

13. The integrated lancet and testing striplet of claim 12, wherein the lancet cap comprises one or more elastomeric arms that couple with defined cutouts in the lancet body for snapping the cap into and out of mating relationship with the lancet body by respective application of sufficient coupling and separation force.

14. The integrated lancet and testing striplet of claim 1, wherein the lancet body and test strip comprise at least one tooth that fits a corresponding slot, along with a mechanism for rotationally stabilizing the test strip relative to the lancet body, for coupling the lancet body and test strip together.

15. The integrated lancet and testing striplet of claim 14, wherein the lancet body and test strip comprise at least two teeth that fit corresponding slots for coupling the lancet body and test strip together with rotational stability.

16. The integrated lancet and testing striplet of claim 15, wherein the lancet body comprises said teeth and the test strip comprises said corresponding slots.

17. The integrated lancet and testing striplet of claim 1, wherein the test strip comprises a base and a cover.

18. The integrated lancet and testing striplet of claim 17, wherein the base has at least one layer of electrically conductive material applied to one or more major surfaces thereof.

19. The integrated lancet and testing striplet of claim 17, wherein the cover has a working electrode applied to one or more major surfaces thereof.

20. The integrated lancet and testing striplet of claim 19, further comprising a trigger electrode.

21. The integrated lancet and testing striplet of claim 17, wherein the base is adhered to the cover by at least one layer of adhesive.

22. The integrated lancet and testing striplet of claim 21, wherein said at least one layer of adhesive is a layer of electrically conductive adhesive.

23. The integrated lancet and testing striplet of claim 21, wherein said at least one layer of adhesive is a layer of non-conductive adhesive.

24. The integrated lancet and testing striplet of claim 17, wherein the sensor-containing portion comprises a sample flow channel.

25. The integrated lancet and testing striplet of claim 24, wherein the sensor-containing portion comprises a sample flow channel, and a working electrode is positioned in said flow channel.

26. The integrated lancet and testing striplet of claim 25, wherein the flow channel has a volume of about 1 microliter or less.

27. The integrated lancet and testing striplet of claim 25, wherein the flow channel has a volume of about 0.5 microliter or less

28. The integrated lancet and testing striplet of claim 25, wherein the flow channel has a volume of about 0.2 microliter or less.

29. The integrated lancet and testing striplet of claim 17, wherein the cover comprises at least one electrical passageway running from an inner face to an outer face.

30. The integrated lancet and testing striplet of claim 17, wherein the cover comprises at least one slot formed therein to attach the sensor-containing portion to at least one tab in the lancet-containing body.

31. The integrated lancet and testing striplet of claim 17, wherein the base comprises at least one opening formed therein to attach the sensor-containing portion to at least one tab in the lancet-containing body.

32. The integrated lancet and testing striplet of claim 17, wherein the base or the cover, or both, has a recess formed in an edge thereof that forms the sample receiving portion of the test strip.

33. The integrated lancet and testing striplet of claim 32, wherein the recess has a hydrophilic material applied thereto.

34. The integrated lancet and testing striplet of claim 32, wherein said lancet is positioned approximately 180°

from said recess.

35. The integrated lancet and testing striplet of claim 34, wherein electrical contact pads are on at least one major surface of the cover.

36. The integrated lancet and testing striplet of claim 34, wherein electrical contact pads are on at least one major surface of the base.

37. The integrated lancet and testing striplet of claim 34, wherein the cover comprises a layer of an electrically conductive or semiconductive material or both.

38. The integrated lancet and testing striplet of claim 37, wherein said working electrode comprises carbon.

39. The integrated lancet and testing striplet of claim 27, wherein said trigger electrode comprises carbon.

40. The integrated lancet and testing striplet of claim 1, wherein the strip is configured to analyze the analyte in a volume of less than about 1 microliter of sample.

41. The integrated lancet and testing striplet of claim 1, wherein the strip is configured to analyze the analyte in a volume of less than about 0.5 microliter of sample.

42. The integrated lancet and testing striplet of claim 1, wherein the strip is configured to analyze the analyte in a volume of less than about 0.2 microliter of sample.

43. The integrated lancet and testing striplet of claim 1, further comprising a lancet cap for securing the lancet before or after use, or both.

44. An analyte test strip for measuring a body glucose level in a diabetes care regimen, comprising:

(a) a base;

(b) a cover;

(c) multiple electrodes including a working electrode electrode applied to one or more major surfaces of the cover;

(d) a layer of electrically conductive material applied to a major surface of the base;

(e) a sample flow channel including assay chemistry for testing a glucose level of an applied body fluid; and

(f) at least one layer of electrically conductive adhesive for adhering the base to the cover, such that at least one electrical passageway exists from an inner face to an outer face of the cover.

45. The analyte test strip of claim 44, wherein the working electrode and a trigger electrode are positioned in said flow channel.

46. The analyte test strip of claim 44, further comprising electrical contact pads on the outer face of the cover.

47. The analyte test strip of claim 44, further comprising a layer of an electrically conductive material applied to a major surface of the cover.

48. The analyte test strip of claim 44, wherein said working electrode comprises carbon.

49. The analyte test strip of claim 48, further comprising a trigger electrode.

50. The analyte test strip of claim 49, wherein the trigger electrode comprises carbon.

51. The analyte test strip of claim 44, wherein the strip is configured to analyze the analyte in a volume of less than about 1 microliter of sample.

52. The analyte test strip of claim 44, wherein the strip is configured to analyze the analyte in a volume of less than about 0.5 microliter of sample.

53. The analyte test strip of claim 44, wherein the strip is configured to analyze the analyte in a volume of less than about 0.2 microliter of sample.

54. The analyte test strip of claim 44, wherein the analyte comprises glucose.

65. The method of claim 44, wherein the loading comprises mating a first recess defined within the lancet body with a latching mechanism of the glucose meter, such that the test striplet is specifically disposed at a lancing orientation.

66. The method of claim 65, wherein the reorienting comprises mating a second recess defined within the lancet body with the same latching mechanism, such that the testing striplet is specifically disposed at a testing orientation.

67. The method of claim 66, wherein each of said pair of recesses comprises a trapezoidal shape.

68. The method of claim 67, wherein the loading comprises mating a first recess defined within the lancet body with a spring-loaded ball and detent mechanism of the glucose meter, such that the test striplet is specifically disposed at a lancing orientation.

69. The method of claim 65, wherein the reorienting comprises mating a second recess defined within the lancet body with the same ball and detent mechanism, such that the testing striplet is specifically disposed at a testing orientation.

55. An analyte test strip for measuring a body glucose level in a diabetes care regimen, comprising:

(a) a base;

(b) a cover;

(c) multiple electrodes including a working electrode and a trigger electrode applied to one or more major surfaces of the cover;

(d) a layer of electrically conductive material applied to a major surface of the base;

(e) a sample flow channel including assay chemistry for testing a glucose level of an applied body fluid;

(f) at least one layer of adhesive for adhering the base to the cover; and

(g) one or more electrically conductive vias defined in the cover and forming an electrical passageway from an inner face to an outer face of the cover.

56. The analyte test strip of claim 55, wherein the analyte comporises glucose.

57. The analyte test strip of claim 55, wherein the working electrode and a trigger electrode are positioned in said flow channel.

58. The analyte test strip of claim 55, further comprising electrical contact pads on the outer face of the cover.

59. The analyte test strip of claim 55, further comprising a layer of an electrically conductive material applied to at least one major surface of the cover.

60. The analyte test strip of claim 55, wherein said working electrode comprises carbon.

61. The analyte test strip of claim 60, further comprising a trigger electrode comprising carbon.

62. A method of providing a sample of body fluid to a test strip for measuring a glucose level within the fluid, comprising:

(a) providing an integrated glucose testing striplet including a lancet needle and a test strip that are coupled at different ends of a lancet body of the striplet;

(b) loading the testing striplet within a striplet-containing analyte meter including arming the lancet needle by removing a lancet cap;

(c) piercing a lancing site with the lancet needle at a predetermined location relative to the meter; and

(d) automatically reorienting the striplet within the glucose meter; and

(e) automatically advancing and contacting a sample receiving portion of the test strip at the lancing site, such that body fluid from the lancing site is automatically applied to the sample receiving portion of the test strip for measuring a glucose level.

63. The method of claim 62, further comprising disarming the lancet needle and disposing of the testing striplet.

64. The method of claim 62, wherein the lancing site remains approximately at said predetermined location relative to the meter when body fluid is applied to the sample receiving portion of the test strip, and wherein the reorienting comprises rotating the striplet.

70. The method of claim 62, wherein the lancing site remains approximately at said predetermined location relative to the meter when body fluid is applied to the sample receiving portion of the test strip, and wherein the test strip and lancet are symmetrically disposed at opposite ends of the lancet body, and the reorienting comprises flipping the striplet.

71. The method of claim 70, wherein the loading comprises mating a first recess defined within the lancet body with a ball and detent mechanism of the glucose meter, such that the test striplet is specifically disposed at a lancing orientation.

72. The method of claim 71, wherein the reorienting further comprises mating a second recess defined within the lancet body symmetrically opposite the first recess with the same ball and detent mechanism, such that the testing striplet is specifically disposed at a testing orientation.

73. The method of claim 72, wherein the loading comprises mating a first recess defined within the lancet body with a latching mechanism of the glucose meter, such that the test striplet is specifically disposed at a lancing orientation.

74. The method of claim 73, wherein the reorienting further comprises mating a second recess defined within the lancet body symmetrically opposite the first recess with the same latching mechanism, such that the testing striplet is specifically disposed at a testing orientation.

75. The method of claim 62, wherein the arming comprises uncoupling a lancet cap by uncoupling one or more elastomeric arms of the lancet cap from defined cutouts in the lancet body by application of sufficient separating force.

76. The method of claim 75, further comprising disarming the lancet needle, including snapping the one or more elastomeric arms of the lancet cap back into mating relationship with the defined cutouts of the lancet body by application of sufficient coupling force.

77. The method of claim 62, further comprising coupling at least one tooth that fits a corresponding slot, and rotationally stabilizing the test strip relative to the lancet body, for coupling the lancet body and test strip together.

78. The method of claim 62, further comprising coupling at least two teeth that fit corresponding slots for coupling the lancet body and test strip together.

79. The method of claim 78, wherein the lancet body comprises said teeth and the test strip comprises said corresponding slots.

80. An integrated lancing and testing kit for measuring a body analyte level in a health care regimen, comprising:

(a) a meter for analyzing the analyte to determine the body glucose level

(b) a cartridge containing one or more integrated lancet and testing striplets; and

(c) wherein the one or more striplets each comprise;

(i) a lancet body including a test strip receiving end and a lancet end;

(ii) a lancet needle coupled with, protruding from, and fixed relative to the lancet end of the lancet body,

(iii) a test strip coupled to the test strip receiving end of the lancet body having multiple electrodes and assay chemistry for testing a glucose level of an applied body fluid; and

(iv) wherein the test strip and lancet needle are relatively disposed at different ends of the striplet for providing both lancing and application of body fluid at a lancing site.

81. The integrated lancing and testing kit of claim 80, wherein the striplet is configured for lancing and application of body fluid at a lancing site by automatically lancing, withdrawing the striplet into the meter, reorienting the striplet within the meter, and re-advancing the striplet.

82. The integrated lancing and testing kit of claim 81, wherein the lancet needle and test strip are separated such as not to be in fluid communication with regard to the body fluid.

83. The integrated lancing and testing kit of claim 82, wherein the lancet needle and test strip are separated sufficiently that test strip is out of reach of spreading analyte prior to withdrawing the striplet into the meter, re-orienting the striplet within the meter, and re-advancing the striplet.

84. The integrated lancing and testing kit of claim 83, wherein the reorienting comprises rotating the striplet with the meter.

85. The integrated lancing and testing kit of claim 81, wherein the reorienting comprises flipping approximately 180 degrees.

86. The integrated lancing and testing kit of claim 80, wherein the test strip and lancet are symmetrically disposed at opposite ends of the lancet body.

87. The integrated lancing and testing kit of claim 80, wherein the lancet body comprises a pair of relatively disposed recesses for respectively positioning the test strip for lancing and application of body fluid at said same lancing/testing site.

88. The integrated lancing and testing kit of claim 80, further comprising a lancet cap for securing the protruding lancet needle.

89. The integrated lancing and testing kit of claim 88, wherein the lancet cap comprises one or more elastomeric arms that couple with defined cutouts in the lancet body for snapping the cap into and out of mating relationship with the lancet body by respective application of sufficient coupling and separation force.

90. The integrated lancing and testing kit of claim 80, further comprising a lancet cap for securing the lancet before or after use, or both.