Integrated diagnostic test system

• US 20050143675A1
• Filed: 06/02/2004
• Published: 06/30/2005
• Est. Priority Date: 12/31/2003
• Status: Active Grant

• Current Assignee: Trividia Health, Inc. (Sinocare, Inc.)
• Original Assignee: Home Diagnostics Incorporated
• Inventors: Modzelewski, Brent E., Neel, Gary T., Casterline, Cameron Scott
• Granted Patent: US 8,147,426 B2
• Time in Patent Office: Days
• US Class Current: 600/583
• CPC Class Codes: A61B 2560/0209 adapted for power saving
• 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 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150175 Adjustment of penetration depth
• CPC Class Codes: A61B 5/150259 Improved gripping, e.g. with high friction pattern or projections on the housing surface or an ergonometric shape
• CPC Class Codes: A61B 5/150305 Packages specially adapted for piercing devices or blood sampling devices kits for diabetes A61M5/003; packaging in general B65D
• 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 5/150503 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 5/150824 by visual feedback
• 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 5/1519 comprising driving means, e.g. a spring, for propelling the piercing unit
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: Y10T 436/110833 Utilizing a moving indicator strip or tape

Abstract

A system for diagnostic testing may include a meter for performing a diagnostic test on a sample applied to a test media and a container configured to contain test media compatible with the meter. The meter may include a closure portion for selectively closing the opening of the container. The system may further provide a sampling device, such as a lancet, operable connected to the container such that that a user may use the sampling device to obtain a sample without disconnecting the sampling device from the container. The system may also provide mechanisms to disable a power source, an auto-on function of the meter, a diagnostic testing function of the meter, or other function of the meter when it has been determined that a triggering event has occurred. The triggering event may be, e.g., the expiration of a certain time period, passage of a certain date, performance of a certain quantity of diagnostic tests, or use of a certain quantity of test media. The system may further provide mechanisms to reconfigure the meter to perform a new function when it has been determined that the triggering event has occurred.

Claims

1. A system for diagnostic testing, the system comprising:

a meter for performing a diagnostic test on a sample applied to a test media; and

a container configured to contain test media compatible with the meter, the container having an opening;

wherein the meter comprises;

an interface for accepting test media in order to perform the diagnostic test;

a controller configured to perform the diagnostic test;

an indicator for indicating a result of the diagnostic test; and

a closure portion for selectively closing the opening of the container.

2. The system of claim 1, wherein the diagnostic test is for the analysis of a biological sample.

3. The system of claim 2, wherein the diagnostic test is for the determination of the presence, concentration or amount of one of:

glucose, ketones, cholesterol, human choriogonadotropin, hemoglobin A1C, fructosamine, carbohydrates, a tumor marker, lead, an anti-epilepsy drug, bilirubin, a liver function marker, a toxin, a metabolite of a toxin, a controlled substance, and a blood coagulation factor.

4. The system of claim 1, wherein the diagnostic test employs a technique comprising at least one of:

a photometric technique, reflection, transmission, scattering, absorption, fluorescence, electrochemiluminescence, an electrochemical technique, coulometry, amperometry, and potentiometry.

5. The system of claim 1, wherein meter further comprises a housing and the closure is either affixed to or integral with the housing.

6. The system of claim 1, further comprising test media contained in the container, the meter being configured to conduct the diagnostic test on a sample applied to the test media contained in the container.

7. The system of claim 6, wherein the meter is calibrated for use with the test media contained in the container.

8. The system of claim 1, wherein the closure is configured to seal the opening against the infiltration of at least one of liquid, vapor and air.

9. The system of claim 1, wherein the closure comprises one of:

a press-fit closure, a twist-off closure, and a child-resistant closure.

10. The system of claim 1, wherein the meter is connected to the container by a flexible connector.

11. The system of claim 10, wherein the flexible connector is a hinge.

12. The system of claim 1, further comprising a sampling device operably connected to the container.

13. The system of claim 12, wherein the sampling device is a lancet.

14. The system of claim 13, wherein the lancet comprises a spring for propelling the lancet to puncture the skin and the lancet is operably connected to the container such that a user may load the spring and release the spring to draw a sample without disconnecting the lancet from the container.

15. The system of claim 13, wherein the lancet comprises a mechanism for adjusting the depth of penetration of the lancet and the lancet is operably connected to the container such that a user may operate the mechanism to adjust the depth of penetration of the lancet without disconnecting the lancet from the container.

16. The system of claim 1, further comprising a user control for controlling a function of the meter.

17. The system of claim 16, wherein the user control includes a button on a lateral side of the meter and the indicator includes a display on a top side of the meter.

18. The system of claim 1, further comprising a media dispensing mechanism for dispensing test media from the container.

19. The system of claim 18, wherein the media dispensing mechanism is configured to dispense test media into the interface.

20. The system of claim 1, wherein the system is configured to be hand held.

21. The system of claim 1, wherein the system further comprises:

data corresponding to at least one of;

a time period, a date, a quantity of diagnostic tests, and a quantity of diagnostic test media;

wherein the controller is configured to examine the data to determine if a triggering event has occurred and to disable a function of the meter when it has been determined that a triggering event has occurred.

22. The system of claim 21, wherein the system further comprises a power source and the controller is configured to disable the power source when it has been determined that a triggering event has occurred.

23. The system of claim 22, wherein the controller is configured to disable the power source by increasing a load on the power source so as to drain the power source

24. The system of claim 23, wherein the meter comprises a clock and the controller is configured to increase the load on the power source by increasing the frequency of the clock.

25. The system of claim 22, wherein the controller is configured to disable the power source by disconnecting the power source.

26. The system of claim 21, wherein the controller further comprises an auto-on function for initiating a diagnostic test upon the insertion of test media into the interface;

and the controller is configured to disable the auto-on function when it has been determined that a triggering event has occurred.

27. The system of claim 21, wherein the controller the controller is configured to disable the diagnostic testing function of the meter and to reconfigure the meter to perform a new function when it has been determined that a triggering event has occurred.

28. The system of claim 27, wherein the controller further comprises an auto-on function for initiating a diagnostic test upon the insertion of test media into the interface;

and the controller is configured to disable the diagnostic testing function by disabling the auto-on function.

29. The system of claim 27, wherein the controller is configured to disable the diagnostic testing function by preventing the indicator from indicating the result of a diagnostic test.

30. The system of claim 27, wherein the controller is configured to reconfigure the function of the meter by causing the indicator to indicate information other than the result of a diagnostic test.

31. The system of claim 30, wherein the other information is at least one of:

time, date, temperature, humidity, and a reading of an environmental sensor.

32. The system of claim 27, wherein the meter further comprises at least one user control and the controller is configured to reconfigure the function of the meter by reconfiguring the function of the at least one user control.

33. The system of claim 21, further comprising test media contained in the container, wherein the data is related to the test media contained in the container.

34. The system of claim 33, wherein the triggering event is related to one of:

an expiration date, and a quantity of the test media contained in the container.

35. The system of claim 21, wherein the triggering event is related to one of:

expiration of the time period, passage of the date, performance of the quantity of diagnostic tests, and use of the quantity of test media.

36. The system of claim 35, wherein the triggering event is related to the expiration of the time period relative to one of:

a date of a first use of an operation of the meter, and a date of first use of an operation of the meter with an associated plurality of test strips.

37. The system of claim 36, wherein the operation of the meter is the performance of a diagnostic test.

43. The device of claim 13, wherein the lancet comprises a mechanism for adjusting the depth of penetration of the lancet and the lancet is operably connected to the container such that a user may operate the mechanism to adjust the depth of penetration of the lancet.

38. A meter for performing a diagnostic test on a sample applied to a test media, the meter comprising:

an interface for accepting test media in order to perform the diagnostic test;

a controller configured to perform the diagnostic test;

an indicator for indicating a result of the diagnostic test; and

a closure portion for selectively closing an opening of a container configured to contain test media compatible with the meter.

39. A meter for performing a diagnostic test on a sample applied to a test media, the meter comprising:

an interface for accepting test media in order to perform the diagnostic test;

a controller configured to perform the diagnostic test;

an indicator for indicating a result of the diagnostic test; and

a housing, the housing having a portion configured to conform to a closure portion of a container configured to contain test media compatible with the meter.

40. A device comprising:

a container configured to contain test media for diagnostic testing of a sample;

a sampling device configured to obtain a sample compatible with the test media which the container is configured to contain;

wherein the sampling device is permanently affixed to the container such that a user may use the sampling device to obtain a sample.

41. The device of claim 40, wherein the sampling device is a lancet.

42. The device of claim 41, wherein the lancet comprises a spring for propelling the lancet to puncture the skin and the lancet is operably connected to the container such that a user may load the spring and release the spring to draw a sample.

44. The device of claim 40, further comprising test media contained in the container.

45. The device of claim 44, wherein the test media comprises test strips for blood glucose testing.

46. A meter for performing a diagnostic test on a sample applied to a test media, the meter comprising:

a power source;

an interface for accepting test media in order to perform the diagnostic test;

a controller configured to perform the diagnostic test;

an indicator for indicating a result of the diagnostic test; and

data corresponding to at least one of;

a time period, a date, a quantity of diagnostic tests, and a quantity of diagnostic test media;

wherein the controller is configured to examine the data to determine if a triggering event has occurred and to disable the power source when it has been determined that a triggering event has occurred.

47. The meter of claim 46, wherein the controller is configured to disable the power source by increasing a load on the power source so as to drain the power source

48. The meter of claim 47, wherein the meter comprises a clock and the controller is configured to increase the load on the power source by increasing the frequency of the clock.

49. The meter of claim 46, wherein the controller is configured to disable the power source by disconnecting the power source.

50. The meter of claim 46, wherein the triggering event is related to one of:

expiration of the time period, passage of the date, performance of the quantity of diagnostic tests, and use of the quantity of test media.

51. The meter of claim 50, wherein the triggering event is related to the expiration of the time period relative to one of:

a date of a first use of an operation of the meter, and a date of first use of an operation of the meter with an associated plurality of test strips.

52. The meter of claim 51, wherein the operation of the meter is the performance of a diagnostic test.

53. The meter of claim 46, wherein the data is related to an associated plurality of test media.

54. The meter of claim 53, wherein the associated plurality of test media is a brand or lot of test media for which the meter has been calibrated.

55. The meter of claim 53, wherein the triggering event is related to an expiration date of the associated plurality of test media.

56. The meter of claim 53, wherein the associated plurality of test media is for a plurality of test media with which the meter has been packaged.

57. The meter of claim 56, wherein the triggering event is related to one of:

an expiration date of the of the test media contained in the package, and the quantity of test media contained in the package.

58. A meter for performing a diagnostic test on a sample applied to a test media, the meter comprising:

a power source;

an interface for accepting test media in order to perform the diagnostic test;

a controller configured to perform the diagnostic test, the controller comprising an auto-on function for initiating a diagnostic test upon the insertion of test media into the interface;

an indicator for indicating a result of the diagnostic test; and

data corresponding to at least one of;

a time period, a date, a quantity of diagnostic tests, and a quantity of diagnostic test media;

wherein the controller is configured to examine the data to determine if a triggering event has occurred and to disable the disable the auto-on function when it has been determined that a triggering event has occurred.

59. The meter of claim 58, wherein the triggering event is related to one of:

expiration of the time period, passage of the date, performance of the quantity of diagnostic tests, and use of the quantity of test media.

60. The meter of claim 59, wherein the triggering event is related to the expiration of the time period relative to one of:

a date of a first use of an operation of the meter, and a date of first use of an operation of the meter with an associated plurality of test strips.

61. The meter of claim 59, wherein the operation of the meter is the performance of a diagnostic test.

62. The meter of claim 58, wherein the data is related to an associated plurality of test media.

63. The meter of claim 62, wherein the associated plurality of test media is a brand or lot of test media for which the meter has been calibrated.

64. The meter of claim 62, wherein the triggering event is related to an expiration date of the associated plurality of test media.

65. The meter of claim 62, wherein the associated plurality of test media is for a plurality of test media with which the meter has been packaged.

66. The meter of claim 65, wherein the triggering event is related to one of:

an expiration date of the test media contained in the package, and the quantity of test media contained in the package.

67. A meter for performing a diagnostic test on a sample applied to a test media, the meter comprising:

a power source;

an interface for accepting test media in order to perform the diagnostic test;

a controller configured to perform the diagnostic test;

an indicator for indicating a result of the diagnostic test; and

data corresponding to at least one of;

a time period, a date, a quantity of diagnostic tests, and a quantity of diagnostic test media;

wherein the controller is configured to examine the data to determine if a triggering event has occurred and to disable the diagnostic testing function of the meter and to reconfigure the meter to perform a new function when it has been determined that a triggering event has occurred.

68. The meter of claim 67, wherein the controller further comprises an auto-on function for initiating a diagnostic test upon the insertion of test media into the interface;

and the controller is configured to disable the diagnostic testing function by disabling the auto-on function.

69. The meter of claim 67, wherein the controller is configured to disable the diagnostic testing function by preventing the indicator from indicating the result of a diagnostic test.

70. The meter of claim 67, wherein the controller is configured to reconfigure the function of the meter by causing the indicator to indicate information other than the result of a diagnostic test.

71. The meter of claim 70, wherein the other information is at least one of:

time, date, temperature, humidity, and a reading of an environmental sensor.

72. The meter of claim 67, wherein the meter further comprises at least one user control and the controller is configured to reconfigure the function of the meter by reconfiguring the function of the at least one user control.

73. The meter of claim 67, wherein the triggering event is related to one of:

expiration of the time period, passage of the date, performance of the quantity of diagnostic tests, and use of the quantity of test media.

74. The meter of claim 73, wherein the triggering event is related to the expiration of the time period relative to one of:

a date of a first use of an operation of the meter, and a date of first use of an operation of the meter with an associated plurality of test strips.

75. The meter of claim 74, wherein the operation of the meter is the performance of a diagnostic test.

76. The meter of claim 67, wherein the data is related to an associated plurality of test media.

77. The meter of claim 76, wherein the associated plurality of test media is a brand or lot of test media for which the meter has been calibrated.

78. The meter of claim 76, wherein the triggering event is related to an expiration date of the associated plurality of test media.

79. The meter of claim 76, wherein the associated plurality of test media is for a plurality of test media with which the meter has been packaged.

80. The meter of claim 79, wherein the triggering event is related to one of:

an expiration date of the test media contained in the package, and the quantity of test media contained in the package.