Glucose monitor and test strip containers for use in same

• US 5,989,917 A
• Filed: 02/13/1996
• Issued: 11/23/1999
• Est. Priority Date: 02/13/1996
• Status: Expired due to Fees

• Current Assignee: Inverness Medical Technology, Inc. (Johnson & Johnson)
• Original Assignee: Selfcare Inc. (Johnson & Johnson)
• Inventors: Moerman, Piet H. C., Siu, Ta, McAleer, Jerome F.
• Primary Examiner(s): Le, Long V.
• Application Number:
  US08/600,449
• Time in Patent Office: 1,379 Days
• Field of Search: 422/50, 422/55, 422/58, 422/61, 422/67, 422/99, 422/102, 422/104, 422/68.1, 436/44, 436/46, 436/50
• US Class Current: 436/46
• CPC Class Codes: B01L 99/00 Subject matter not provided for in other groups of this subclass
• CPC Class Codes: G01N 2035/00108 Test strips, e.g. paper
• CPC Class Codes: G01N 2035/00782 reprogrammmable code
• CPC Class Codes: G01N 33/4875 Details of handling test elements, e.g. dispensing or storage, not specific to a particular test method test-elements per se B01L, automatic analysers G01N35/00, in-vivo analysis on the human body for medical diagnosis A61B
• CPC Class Codes: G01N 35/00732 Identification of carriers, materials or components in automatic analysers
• CPC Class Codes: Y10T 436/112499 with sample on test slide
• CPC Class Codes: Y10T 436/115831 Condition or time responsive

Abstract

A test meter of the type which receives a disposable test strip and a sample of bodily fluid from a patient and performs an electrochemical analysis of the amount of an analyte such as glucose in the sample includes a receptacle for receiving a container in which disposable test strips are provided, and a mechanism for reading information about the disposable test strips that is affixed to the container. For example, calibration values can be applied to the container in the form of a machine readable bar-code, a magnetic stripe, a memory chip or as a resonant wire loop. By automatically obtaining calibration values from the container in which the strips are provided, the chances of using the wrong calibration information are greatly reduced. The container may also contain information readable by the meter including the expiration date, and the number of test strips in the container.

Claims

1. A test meter which receives a disposable test strip and a sample of bodily fluid from a patient and performs an electrochemical analysis of the amount of an analyte in the sample, comprising

(a) a housing having formed therein

a slot for receiving a disposable test strip with a sample of bodily fluid thereon, said slot forming a connection between the exterior of the housing and an interior region in which electronics for measuring the amount of analyte are disposed;

and

a receptacle for receiving a container in which disposable test strips are provided, said receptacle having an open end providing access to the receptacle from the exterior of the housing and through which the container is received, and an inner end which does not provide an operative connection for disposable test strips to the interior region of the housing, said container having affixed thereto information specific to the disposable test strips provided in the container in a form readable by the test meter;

(b) means for reading the information affixed to the container while it is in the receptacle.

2. The test meter according to claim 1, wherein the means for reading the information comprises a bar-code reader.

3. The test meter according to claim 1, wherein the means for reading the information comprises a radio frequency emitter and receiver effective to evaluate a resonant wire loop used to store information specific to the test strips in the container.

4. The test meter according to claim 1, wherein the means for reading the information comprises a microprocessor for retrieving information from a memory chip used to store information specific to the test strips in the container.

5. The meter according to claim 1, wherein the information specific to the disposable test strip includes calibration values for the disposable test strips, and wherein the meter further comprises means for applying the calibration values to a raw data value to produce a calibrated value for the amount of analyte.

6. The meter according to claim 5, further comprising means for displaying the calibrated value for the amount of analyte.

7. The meter according to claim 1, wherein the information specific to the disposable test strip includes the number of test strips originally provided in the container, and the meter further comprises a data storage register for storing a value equal to the number of test strips used from the container and means for generating an error signal whenever the value stored in the data storage register exceed the number of test strips originally provided in the container.

8. The meter according to claim 7, wherein the information specific to the disposable test strip includes calibration values for the disposable test strips, and wherein the meter further comprises means for applying the calibration values to a raw data value to produce a calibrated value for the amount of analyte.

9. The meter according to claim 1, wherein the information specific to the disposable test strip includes the expiration date of test strips provided in the container, and the meter further comprises a data storage register for storing the current date and means for generating an error signal whenever the value stored in the data storage register is later than the expiration date of the test strips provided in the container.

10. The meter according to claim 9, wherein the means for generating an error signal generates a low level error signal which causes the meter to display a calibrated result and a warning when the date stored in the data register is within some predetermined number of days before or after the expiration date, and a high level error signal which causes the meter to refuse to display a calibrated result when the date stored in the data register is more than the predetermined number of days after the expiration date.

11. The meter according to claim 9, wherein the information specific to the disposable test strip includes calibration values for the disposable test strips, and wherein the meter further comprises means for applying the calibration values to a raw data value to produce a calibrated value for the amount of analyte.

12. The meter according to claim 1, further comprising means for rendering the information affixed to the container unreadable when a predetermined set of conditions is met.

13. The meter according to claim 1, wherein the analyte is glucose.

14. The test meter according to claim 13, wherein the means for reading the information comprises a bar-code reader.

15. The test meter according to claim 13, wherein the means for reading the information comprises a radio frequency emitter and receiver effective to evaluate a resonant wire loop used to store information specific to the test strips in the container.

16. The test meter according to claim 13, wherein the means for reading the information comprises a microprocessor for retrieving information from a memory chip used to store information specific to the test strips in the container.

17. The meter according to claim 13, wherein the information specific to the disposable test strip includes calibration values for the disposable test strips, and wherein the meter further comprises means for applying the calibration values to a raw data value to produce a calibrated value for the amount of analyte.

18. The meter according to claim 17, further comprising means for displaying the calibrated value for the amount of analyte.

19. The meter according to claim 13, wherein the information specific to the disposable test strip includes the number of test strips originally provided in the container, and the meter further comprises a data storage register for storing a value equal to the number of test strips used from the container and means for generating an error signal whenever the value stored in the data storage register exceed the number of test strips originally provided in the container.

20. The meter according to claim 19, wherein the information specific to the disposable test strip includes calibration values for the disposable test strips, and wherein the meter further comprises means for applying the calibration values to a raw data value to produce a calibrated value for the amount of analyte.

21. The meter according to claim 13, wherein the information specific to the disposable test strip includes the expiration date of test strips provided in the container, and the meter further comprises a data storage register for storing the current date and means for generating an error signal whenever the value stored in the data storage register is later than the expiration date of the test strips provided in the container.

22. The meter according to claim 21, wherein the means for generating an error signal generates a low level error signal which causes the meter to display a calibrated result and a warning when the date stored in the data register is within some predetermined number of days before or after the expiration date, and a high level error signal which causes the meter to refuse to display a calibrated result when the date stored in the data register is more than the predetermined number of days after the expiration date.

23. The meter according to claim 21, wherein the information specific to the disposable test strip includes calibration values for the disposable test strips, and wherein the meter further comprises means for applying the calibration values to a raw data value to produce a calibrated value for the amount of analyte.

24. The meter according to claim 13, further comprising means for rendering the information affixed to the container unreadable when a predetermined set of conditions is met.

25. A system for the detection of glucose comprising,

a test meter which receives a disposable test strip and a sample of bodily fluid from a patient and performs an electrochemical analysis of the amount of an analyte in the sample, said meter comprising:

(a) a housing having formed therein

slot for receiving a disposable test strip with a sample of bodily fluid thereon, said slot forming a connection between the exterior of the housing and an interior region in which electronics for measuring the amount of analyte are disposed; and

a receptacle for receiving a container in which disposable test strips are provided, said receptacle having an open end providing access to the receptacle from the exterior of the housing and through which the container is received, and an inner end which does not provide an operative connection for disposable test strips to the interior region of the housing, said container having affixed thereto information specific to the disposable test strips provided in the container in a form readable by the test meter;

(b ) means for reading the information affixed to the container while it is in the receptacle, and

a container of disposable glucose test strips sized to be placed within the receptacle, said container comprising;

(a) a sealable body member for receiving at least one glucose test strip;

(b) machine-readable means for storing information specific to glucose test strips provided in the container; and

(c) at least one disposable glucose test strip for electrochemical analysis of the amount of the glucose in a sample disposed within the sealable body member.

26. The system according to claim 25, wherein the machine-readable means is a bar-code.

27. The system according to claim 25, wherein the machine-readable means is a memory chip.

28. The system according to claim 25, wherein the machine-readable means is a resonant wire loop.

29. The according to claim 25, wherein the machine-readable means is a magnetic stripe.

30. The system according to claim 25, further comprising means for rendering the machine-readable means unreadable in response to an externally applied signal.

31. The system according to claim 25, wherein the information specific to the test strips includes calibration values for the test strips.

32. The system according to claim 31, wherein the information specific to the test strips includes the number of test strips originally provided in the container.

33. The system according to claim 31, wherein the information specific to the test strips includes the expiration date of the test strips provided in the container.

34. The system according to claim 25, wherein the information specific to the test strips includes the number of test strips originally provided in the container.

35. The system according to claim 25, wherein the information specific to the test strips includes the expiration date of the test strips provided in the container.

36. A method for detection of glucose in a sample of bodily fluid from a patient comprising the steps of:

providing an analytical system comprising;

a test meter which receives a disposable glucose test strip and a sample of bodily fluid from a patient and performs an electrochemical analysis of the amount of glucose in the sample, said meter comprising;

(a) a housing having formed therein

a slot for receiving a disposable glucose test strip with a sample of bodily fluid thereon, said slot forming a connection between the exterior of the housing and an interior region in which electronics for measuring the amount of glucose are disposed; and

a receptacle for receiving a container in which disposable glucose test strips are provided, said receptacle having an open end providing access to the receptacle from the exterior of the housing and through which the container is received, and an inner end which does not provide an operative connection for disposable test strips to the interior region of the housing, said container having affixed thereto information specific to the disposable test strips provided in the container in a form readable by the test meter;

(b) means for reading the information affixed to the container while it is in the receptacle, and

a container of disposable glucose test strips disposed within the receptacle, said container comprising

(a) a sealable body member for receiving at least one disposable glucose test strip;

(b) machine-readable means for storing information specific to glucose test strips provided in the container; and

(c) at least one disposable glucose test strip for electrochemical analysis of the amount of the glucose in a sample disposed within the sealable body member;

removing a test strip from the container disposed within the receptacle;

inserting the removed test strip into the slot formed in the housing; and

applying the sample to the test strip.