Method and apparatus for coding diagnostic meters

• US 8,388,905 B2
• Filed: 03/13/2006
• Issued: 03/05/2013
• Est. Priority Date: 03/13/2006
• Status: Active Grant

• Current Assignee: Trividia Health, Inc. (Sinocare, Inc.)
• Original Assignee: Nipro Diagnostics, Inc.
• Inventors: Neel, Gary T., Modzelewski, Brent E., Oti, Carlos, Caban, Allan Javier, Rounds, George R.
• Primary Examiner(s): MERKLING, SALLY ANNE
• Application Number:
  US11/373,284
• Publication Number:
  US 20070212258A1
• Time in Patent Office: 2,549 Days
• Field of Search: 436/50, 436/8, 436/14, 422/58
• US Class Current: 422/401
• CPC Class Codes: G01N 33/48757 Test elements dispensed from a stack
• CPC Class Codes: G01N 33/48771 Coding of information, e.g. calibration data, lot number

Abstract

A system for diagnostic testing may include a meter for performing a diagnostic test on a sample applied to a test media, the meter having a housing and an interface for receiving a signal representing coding information, and a container configured to contain test media compatible with the meter, the container having a coding element associated therewith. Additionally, the system may provide a mechanisms for removing the meter from an interconnected test container and reattaching it to a new container using on-container coding methods that can recalibrate the meter for the new container of test strips. The system may further provide a sampling device, such as a lancet, operably 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. In addition, the system may further provide a refillable test strip container which includes a foil pouch of test strips with a desiccant pill used to refill test strip container when empty.

Claims

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

a meter for performing a diagnostic test on a sample applied to test media, the meter having a housing, a meter housing attachment portion, and an interface for receiving a signal representing coding information;

a container having a base, walls, and a container attachment portion, the container including continuous interior volume, the continuous interior volume containing a plurality of loose, singulated test media housed therein compatible with the meter, and the container having a coding element associated therewith, wherein the meter housing attachment portion is shaped to conform to the container attachment portion to permit a press-fit engagement between the meter housing and the container;

a coding pattern provided on the coding element configured to present coding information via the interface;

alignment features disposed on the meter housing attachment portion and the container attachment portion, and configured to interlock and align the container, and the meter in a single predetermined axial orientation with respect to each other, thereby preventing the press-fit engagement between the meter housing and the container if the meter housing and the container are not aligned,

wherein the meter and the container are configured to form an integral unit.

2. The system for diagnostic testing of claim 1, wherein the meter housing is configured to close an opening of the container.

3. The system for diagnostic testing of claim 1, wherein the coding element is sized to fit on a top, bottom, or side portion of the container.

4. The system for diagnostic testing of claim 1, wherein the coding pattern provided on the coding element is directly printed on the container.

5. The system for diagnostic testing of claim 1, wherein the coding element is a contact pad attached to the container.

6. The system for diagnostic testing of claim 5, wherein the contact pad is attached to a top, bottom, or side portion of the container.

7. The system for diagnostic testing of claim 5, wherein the contact pad comprises an analog interface.

8. The system for diagnostic testing of claim 5, wherein the contact pad, comprises a digital interface.

9. The system for diagnostic testing of claim 1, wherein the coding element is a memory chip.

10. The system for diagnostic testing of claim 9, wherein the memory chip is an electrically erasable programmable read-only memory chip.

11. The system for diagnostic testing of claim 9, wherein the coding element further comprises a circuit board.

12. The system for diagnostic testing of claim 11, wherein the circuit board is attached to a top, bottom, or side portion of the container.

13. The system for diagnostic testing of claim 9, wherein the memory chip is configured to be disabled after the meter performs a predetermined number of diagnostic tests.

14. The system for diagnostic testing of claim 1, wherein the coding element is a near field communication device.

15. The system for diagnostic testing of claim 14, wherein the near field communication device is a radio frequency device.

16. The system for diagnostic testing of claim 15, wherein the radio frequency device is attached to a top, bottom, or side portion of the container.

17. The system for diagnostic testing of claim 15, wherein the interface is wireless.

18. The system for diagnostic testing of claim 15, wherein the radio frequency device is configured to be disabled after the meter performs a predetermined number of diagnostic tests.

19. The system for diagnostic testing of claim 1, wherein the container further comprises a display configured to display results of a diagnostic test.

20. The system for diagnostic testing of claim 1, wherein the meter is configured to attach to a side portion of the container.

21. The system for diagnostic testing of claim 1, further comprising an integrated sampling device, forming a composite diagnostic device.

22. The system for diagnostic testing of claim 21, wherein the sampling device is a lancet.

23. The system for diagnostic testing of claim 21, wherein the meter and the sampling device are configured to be separatable devices.

24. The system for diagnostic testing of claim 21, wherein the meter and the sampling device are connected by a clip member.

25. The system for diagnostic testing of claim 21, wherein the meter and the sampling device are connected by an attachment member having at least one hole.

33. The system of claim 1, wherein the alignment features configured to interlock comprise a tab and a slot, wherein one of the tab or the slot is disposed on the container and the other of the tab or the slot is disposed on the meter housing.

26. A test system for determining an analyte concentration in a fluid sample, comprising:

a sensor container having a base, a lid, and a sensor container attachment portion, the sensor container including continuous interior volume with a plurality of loose, singulated test sensors housed therein, the sensor container including a calibration label attached thereto, the calibration label including a plurality of electrical contacts located thereon, the electrical contacts being adapted to encode calibration information onto the calibration label; and

a testing device having an auto-calibration feature external to the testing device, and a testing device attachment portion, the testing device being adapted to determine the analyte concentration in the fluid sample, the auto-calibration feature including a plurality of calibration elements being adapted to communicate with the plurality of electrical contacts on the calibration label, wherein the testing device attachment portion is shaped to conform to the sensor container attachment portion to permit a press-fit engagement between the testing device and the sensor container,

wherein the testing device is adapted to determine the calibration information encoded on the calibration label in response to the calibration elements engaging the electrical contacts when the testing device and the sensor container are press-fit engaged, the encoded calibration information being determined without inserting the sensor container or the calibration label into the testing device.

27. The test system of claim 26, wherein the calibration label is attached to the lid of the sensor container.

28. The test system of claim 26, wherein the testing device and the auto-calibration feature form a digital electronic circuit.

29. The test system of claim 26, wherein the testing device and the auto-calibration feature form an analog electronic circuit.

30. The test system of claim 26, wherein the calibration label is symmetrically shaped.

31. The test system of claim 26, wherein the plurality of test sensors is a plurality of electrochemical test sensors.

32. The test system of claim 26, wherein the plurality of test sensors is a plurality of optical test sensors.