Method and apparatus for encoding test strips

• US 9,176,091 B2
• Filed: 09/16/2011
• Issued: 11/03/2015
• Est. Priority Date: 09/17/2010
• Status: Active Grant

• Current Assignee: Agamatrix Incorporated (AgaMatrix Holdings LLC d/b/a WaveForm Diabetes)
• Original Assignee: Agamatrix Incorporated (AgaMatrix Holdings LLC d/b/a WaveForm Diabetes)
• Inventors: Iyengar, Sridhar, Boiteau, Charles, Forest, Martin, Butters, Colin
• Primary Examiner(s): DIETERLE, JENNIFER M
• Application Number:
  US13/823,650
• Publication Number:
  US 20130175184A1
• Time in Patent Office: 1,509 Days
• Field of Search: 20440301-40315, 600/345, 422/82.01, 435/287.1
• US Class Current: 1/1
• CPC Class Codes: A61B 5/05 Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves impedance plethysmography A61B5/0295; measuring movement of the entire body or parts thereof A61B5/11; detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof A61B5/24
• CPC Class Codes: A61B 5/14 Devices for taking samples of blood hypodermic syringes A61M5/00; Measuring characteristics of blood in vivo, e.g. gas concentration within the blood, pH-value of blood measuring of blood pressure A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: C12Q 1/00 Measuring or testing processes involving enzymes, nucleic acids or microorganisms measuring or testing apparatus with condition measuring or sensing means, e.g. colony counters, C12M1/34; Compositions therefor; Processes of preparing such compositions
• CPC Class Codes: G01N 27/327 Biochemical electrodes , e.g. electrical or mechanical details for in vitro measurements
• CPC Class Codes: G01N 27/3272 Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels optical biosensors G01N33/52
• CPC Class Codes: G01N 27/3273 Devices therefor, e.g. test element readers, circuitry details not specific to biochemical electrodes G01N33/4875
• CPC Class Codes: G01N 33/48771 Coding of information, e.g. calibration data, lot number

Abstract

A test meter for receiving a test strip comprises:

• • (a) a housing;
  • (b) electronic circuitry disposed within the housing and
  • (c) a strip port connector connected to the electronic circuitry and extending to an opening in the housing, said strip port connector connecting the electronic circuitry with a received test strip. The strip port connector contains a pair of top and bottom contacts, said top and bottom contacts having a proximal end and a distal end and a central contact portion, the top and bottom contacts of the pair are transversely aligned with one another; and the distal ends of the top and bottom contacts are separated or separable from one another by insertion of a test strip between the opposed contacts. The contacts and the meter are adapted to permit detection of faulty contacts and/or coding associated with an inserted test strip.

Claims

1. A method for determining the concentration of an analyte in a sample comprising the steps of:

inserting an electrochemical test strip for detecting the analyte into a test meter,

said test strip being generally planar and comprising a sample cell for receiving a test sample for analysis and electrodes disposed within the sample cells for performing an electrochemical assay, said test strip having a top surface and a bottom surface, wherein the test strip comprises a connection region and wherein the test strip further comprises;

(a) electrical connectors for connecting the electrodes to a test meter, said electrical connectors being disposed within the connection region and exposed for connection on the top surface, and

(b) a plurality of encoding pads disposed within the connection region on the bottom surface of the test strip, wherein at least two of the encoding pads are in electrical connection with each other; and

wherein said test meter comprises;

(a) a housing;

(b) electronic circuitry disposed within the housing and configured to test for electrical contact between the pair of top and bottom contacts one or more times when no test strip is received in the meter, and

(c) a strip port connector connected to the electronic circuitry and extending to an opening in the housing, said strip port connector connecting the electronic circuitry with the received test strip, wherein

the strip port connector contains a pair of opposed contacts, the pair having a top contact and a bottom contact, said top and bottom contacts having a proximal end and a distal end and a central contact portion,

the top and bottom contacts of the pair are transversely aligned with one another; and

the top and bottom contacts are biased such that the central contact portions of the contacts are in electrical contact with one another when no test strip is received in the test meter, and

the distal ends of the top and bottom contacts are separable from one another by insertion of the test strip between the opposed contacts;

introducing a sample into the test strip, measuring an initial value for concentration of analyte; and

adjusting the initial concentration of analyte as needed based upon information conveyed by encoding pads on the test strip to determine the concentration of analyte in the sample.

2. The method of claim 1, wherein the analyte is glucose and the sample is blood or interstitial fluid.

11. The test meter of claim 1, wherein one of the top and bottom contacts is a flexible bent spring, and the other of the top and bottom contacts is a flat contact surface.

12. The test meter of claim 11, wherein the housing comprises a ledge adjacent to the distal end of the flexible bent spring contact, said ledge limiting deflection of the adjacent contact in the event spring forces of the top and bottom contacts are mismatched.

13. The test meter of claim 1, wherein the electronic circuitry is configured to check for electrical contact between the opposed contacts a predetermined number of times per day.

14. The test meter of claim 13, wherein the circuitry is configured to check for electric contact from 10 or 24 times per day.

15. The test meter of claim 1, wherein the electronic circuitry is configured to check for electrical contact between the opposed contacts at predetermined time intervals.

16. The test meter of claim 15, wherein the, electronic circuitry is configured to check for electrical contact between the opposed contacts at an interval selected from the group consisting of every 5 minutes, every 30 minutes and every hour.

17. The test meter of claim 1, wherein the electronic circuitry is configured to check for electrical contact between the opposed contacts immediately following removal of the test strip from the strip port connector.

18. The test meter of claim 1, wherein the electronic circuitry is configured to generate an error state if the extent of electrical contact between the top and bottom contacts in the absence of the received test strip fails to me a predefined threshold.

19. The test meter of claim 1, wherein the test meters comprises at least one additional pair of opposed contacts in the strip port connector, wherein

each of the additional pairs of contacts includes an additional top and an additional bottom contact, said additional top and bottom contacts having a proximal end and a distal end and a central contact portion;

the additional top and bottom contacts of each the additional pair are transversely aligned with one another; and

the distal ends of the additional top and bottom contacts of each additional pair are separable from one another by insertion of the test strip between the opposed additional contacts.

20. The test meter of claim 19, wherein the contacts of at least one additional pair of contacts are biased such that the central contact portions of the contacts are in electrical contact with one another when no test strip is received in the test meter.

21. The test meter of claim 19, where the plurality of pairs of top and bottom contacts include a first pair having a first longitudinal length between the proximal end and the contact region of the central portion, and a second pair having a second longitudinal length, different from the first longitudinal length, between the proximal end and the contact region of the central portion.

22. The test meter of claim 21, where the meter comprises five pairs of top and bottom contacts, three pairs having a shorter longitudinal length and two having a longer longitudinal length, disposed in an alternating array.

3. A method for monitoring a test meter that receives an electrochemical test strip to confirm integrity of the contacts that make electrical connection to the electrochemical test strip, wherein

the meter comprises a strip port connector comprising a pair of opposed contacts, the pair of contacts having a top contact and a bottom contact, said top and bottom contacts having a proximal end and a distal end and a central contact portion,

the top and bottom contacts of the pair are transversely aligned with one another;

the top and bottom contacts are biased such that the central contact portions of the contacts are in electrical contact with one another when no test strip is received in the test meter, and

the distal ends of the top and bottom contacts are separable from one another by insertion of the test strip between the opposed contacts, said method comprising the step of testing for electrical contact between the pair of top and bottom contacts at one or more times when no test strip is received in the test meter.

4. The method of claim 3, wherein testing for electrical contact between the opposed contacts is performed a predetermined number of times per day.

5. The method of claim 4, wherein testing for electrical contact between the opposed contacts is performed a 10 or 24 times per day.

6. The method of claim 3, wherein testing for electrical contact between the opposed contacts is performed at predetermined time intervals.

7. The method of claim 6, wherein testing for electrical contact between the opposed contacts is performed at a predetermined time interval selected from the group consisting of every 5 minutes, every 30 minutes and every hour.

8. The method of claim 3, wherein testing for electrical contact between the opposed contacts is performed immediately following removal of the test strip from the strip port connector.

9. The method of claim 3, further comprising the step of generating an error state if the extent of electrical contact between the top and bottom contacts in the absence of the received test strip fails to meet a predefined threshold.

10. A test meter for receiving a test strip comprising:

(a) a housing;

(b) electronic circuitry disposed within the housing and

(c) a strip port connector connected to the electronic circuitry and extending to an opening in the housing, said strip port connector connecting the electronic circuitry with a received test strip, wherein

the strip port connector contains a pair of opposed contacts, the pair having a top contact and a bottom contact, said top and bottom contacts having a proximal end and a distal end and a central contact portion,

the top and bottom contacts of the pair are transversely aligned with one another; and

the top and bottom contacts are biased such that the central contact portions of the contacts are in electrical contact with one another when no test strip is received in the test meter, and

the distal ends of the top and bottom contacts are separable from one another by insertion of the test strip between the opposed contacts,

wherein the electronic circuitry is configured to test for electrical contact between the pair of top and bottom contacts one or more times when no test strip is received in the meter.

23. A test meter for receiving a test strip comprising:

(a) a housing;

(b) electronic circuitry disposed within the housing and

(c) a strip port connector connected to the electronic circuitry and extending to an opening in the housing, said strip port connector connecting the electronic circuitry with a received test strip, wherein

the strip port connector contains a pair of opposed contacts, the pair having a top contact and a bottom contact, said top and bottom contacts having a proximal end and a distal end and a central contact portion,

the top and bottom contacts of the pair are transversely aligned with one another;

the top and bottom contacts are biased towards each other such that the central contact portions of the contacts are close to but not in electrical contact with one another when no test strip is received in the test meter, and

the distal ends of the top and bottom contacts are separable from one another by insertion of the test strip between opposed contacts such that the central contact portions contact the received test strip, wherein one of the top or bottom contacts is connected to the electronic circuitry to read encoding marks disposed on one surface of the test strip, and the other of the top or bottom contacts is connected to the electronic circuitry to obtain information about measurements made by the test strip on a sample introduced into the test strip, and

wherein the electronic circuitry is configured to test for electrical contact between the pair of top and bottom contacts one or more times when no test strip is received in the meter.

24. A test meter for receiving a test strip comprising:

(a) a housing;

(b) electronic circuitry disposed within the housing and

(c) a strip port connector connected to the electronic circuitry and extending to an opening in the housing, said strip port connector connecting the electronic circuitry with a received test strip, wherein

the strip port connector comprises a pair of contacts, the pair of contacts having a top contact and a bottom plate, said top contact having a proximal end and a distal end and a central contact portion and said bottom plate being disposed in alignment with the central contact portion;

the top contact is biased such that the central contact portions of the contacts are in electrical contact with one another when no test strip is received in the test meter,

the distal ends of the top contact and the plate are separable from one another by insertion of the test strip therebetween, and

the electronic circuitry is configured to test for electrical contact between the top contact and the bottom plate at one or more times when no test strip is received in the test meter.

25. A test meter for receiving a test strip comprising:

(a) a housing;

(b) electronic circuitry disposed within the housing and

(c) a strip port connector connected to the electronic circuitry and extending to an opening in the housing, said strip port connector connecting the electronic circuitry with a received test strip, wherein

the strip port connector receives the test strip through one longitudinal end of the strip port connector,

the strip port connector contains a pair of opposed contacts, the pair having a top contact and a bottom contact, said top and bottom contacts having a proximal end and a distal end and a central contact portion,

the top and bottom contacts of the pair are transversely aligned with one another; and

one of the top and bottom contacts extends longitudinally within the strip port connector to a greater extent than the other,

the top and bottom contacts are biased such that the central portions of the top and bottom contacts are in electrical contact with one another when no test strip is received in the test meter, and

the distal ends of the top and bottom contacts being separable from one another by insertion of the test strip between the opposed contacts,

wherein the electronic circuitry is configured to test for electrical contact between the pair of top and bottom contacts one or more times when no test strip is received in the meter.

26. A test meter for receiving a test strip comprising:

(a) a housing;

(b) electronic circuitry disposed within the housing and

(c) a strip port connector connected to the electronic circuitry and extending to an opening in the housing, said strip port connector connecting the electronic circuitry with a received test strip, wherein

the strip port connector contains a pair of opposed contacts, the pair having a top contact and a bottom contact, said top and bottom contacts having a proximal end and a distal end and a central contact portion,

the top and bottom contacts of the pair are transversely aligned with one another;

the top and bottom contacts are biased such that the central contact portions of the contacts are in electrical contact with one another when no test strip is received in the test meter, and

the distal ends of the top and bottom contacts are separable from one another by insertion of the test strip between the opposed contacts, wherein one of the top or bottom contacts is connected to the electronic circuitry to read encoding marks disposed on one surface of a test strip, and the other of the top or bottom contacts is connected to the electronic circuitry to obtain information about measurements made by the test strip on a sample introduced into the test strip,

wherein the electronic circuitry is configured to test for electrical contact between the pair of top and bottom contacts one or more times when no test strip is received in the meter.

27. The test meter of claim 26, wherein one of the top and bottom contacts extends longitudinally within the strip port connector to a greater extent than the other.

28. The test meter of claim 26, wherein one of the top and bottom contacts extends longitudinally within the strip port connector to a greater extent than the other.