Integrated diagnostic test system

• US 8,147,426 B2
• Filed: 06/02/2004
• Issued: 04/03/2012
• Est. Priority Date: 12/31/2003
• Status: Active Grant

• Current Assignee: Trividia Health, Inc. (Sinocare, Inc.)
• Original Assignee: Nipro Diagnostics, Inc.
• Inventors: Neel, Gary T., Casterline, Cameron Scott, Modzelewski, Brent E.
• Primary Examiner(s): SZMAL, BRIAN SCOTT
• Application Number:
  US10/857,917
• Publication Number:
  US 20050143675A1
• Time in Patent Office: 2,862 Days
• Field of Search: 600/583, 600/584, 606181-183, 435/287.1, 422/50, 422/58, 422/68.1, 221/258, 221/25, 436/44, 702/22, 702/25
• US Class Current: 600/584
• 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 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 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 meter for performing a diagnostic test on a sample applied to a test media, the meter comprising:

an interface for accepting test media individually inserted from an exterior of the meter, and configured 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 to an interior volume of a container, the interior volume configured to be user accessible and to contain a plurality of loose, singulated test media compatible with the meter.

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

an interface for accepting test media individually inserted from an exterior of the meter, and configured 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 meter housing, the housing having a portion configured to conform to a closure portion of a container, the container having an interior volume configured to be user accessible and to contain a plurality of loose, singulated test media compatible with the meter.

3. 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 the controller has determined that a triggering event has occurred.

4. The meter of claim 3, 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.

5. The meter of claim 4, 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.

6. The meter of claim 4, wherein the operation of the meter is the performance of a diagnostic test.

7. The meter of claim 3, wherein the data is related to an associated plurality of test media.

8. The meter of claim 7, wherein the associated plurality of test media is a brand or lot of test media for which the meter has been calibrated.

9. The meter of claim 7, wherein the triggering event is related to an expiration date of the associated plurality of test media.

10. The meter of claim 7, wherein the associated plurality of test media is for a plurality of test media with which the meter has been packaged.

11. The meter of claim 10, 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.

12. 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 the controller has determined that a triggering event has occurred.

13. The meter of claim 12, 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.

14. The meter of claim 12, wherein the controller is configured to disable the diagnostic testing function by preventing the indicator from indicating the result of a diagnostic test.

15. The meter of claim 12, 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.

16. The meter of claim 15, wherein the other information is at least one of:

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

17. The meter of claim 12, 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.

18. The meter of claim 12, 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.

19. The meter of claim 18, 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.

20. The meter of claim 19, wherein the operation of the meter is the performance of a diagnostic test.

21. The meter of claim 12, wherein the data is related to an associated plurality of test media.

22. The meter of claim 21, wherein the associated plurality of test media is a brand or lot of test media for which the meter has been calibrated.

23. The meter of claim 21, wherein the triggering event is related to an expiration date of the associated plurality of test media.

24. The meter of claim 21, wherein the associated plurality of test media is for a plurality of test media with which the meter has been packaged.

25. The meter of claim 24, 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.