Diagnostic strip coding system and related methods of use

• US 20070015286A1
• Filed: 07/15/2005
• Published: 01/18/2007
• Est. Priority Date: 07/15/2005
• Status: Active Grant

• Current Assignee: Trividia Health, Inc. (Sinocare, Inc.)
• Original Assignee: Nipro Diagnostics, Inc.
• Inventors: Oti, Carlos, Neel, Gary, Will, Adam, Caban, Allan, Modzelewski, Brent
• Granted Patent: US 9,012,232 B2
• Time in Patent Office: Days
• US Class Current: 436/149
• CPC Class Codes: G01N 2035/00851 process control parameters
• 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 33/48771 Coding of information, e.g. calibration data, lot number
• CPC Class Codes: Y10T 436/144444 Glucose

Abstract

An auto-calibration system for diagnostic test strips is described for presenting data individually carried on each test strip readable by a diagnostic meter. The carried data may include an embedded code relating to data particular to that individual strip. The data is presented so at to be read by a meter associated with the diagnostic test strip in order to avoid manually inputting the information.

Claims

1. A diagnostic test strip comprising:

at least one electrically insulating layer;

a conductive pattern formed on the at least one insulating layer including at least one electrode disposed on the at least one insulating layer at a proximal region of the strip, electrical strip contacts disposed on at least one insulating layer at a distal region of the strip, and conductive traces electrically connecting the electrodes to at least some of the electrical strip contacts;

a reagent layer contacting at least a portion of at least one electrode; and

at least one discrete portion of electrical insulating material disposed over at least one of the electrical strip contacts to at least partially form a distinct pattern readable to identify data particular to the test strip.

2. The strip of claim 1, wherein each of the at least one electrodes is individually connected to one contact in a first plurality of electrical strip contacts.

3. The strip of claim 2, wherein the conductive pattern at the distal region of the strip includes a second plurality of electrical strip contacts.

4. The strip of claim 3, wherein the first and second plurality of electrical strip contacts are positioned to form distinct groups of electrical contacts, the groups being spaced from one another.

5. The strip of claim 3, wherein the second plurality of electrical strip contacts form a discrete set of contacting pads.

6. The strip of claim 5, wherein the distinct pattern is configured by covering certain contacting pads with the electrical insulating material.

7. The strip of claim 1, wherein the insulating material comprises a non-conductive insulating ink.

8. The strip of claim 3, wherein an electrically insulating region separates the first and second plurality of electrical strip contacts.

9. The strip of claim 5, wherein the contacting pads are configured for contact, when inserted into a compatible meter, with a plurality of contacts in a corresponding connector of the meter.

10. The strip of claim 9, further comprising a grounding contacting pad configured to establish a common connection to electrical ground.

11. The strip of claim 10, wherein said grounding contacting pad is positioned on the strip proximally relative to the remaining contacting pads through a non-conductive notch portion at a distal region of the strip.

12. The strip of claim 3, wherein an additional conductive pattern is formed on the insulating layer on a side opposite from that including the first and second plurality of electrical strip contacts, the additional conductive pattern comprising a third plurality of electrical strip contacts and at least one discrete portion of electrical insulating material disposed over at least one of the third plurality of electrical strip contacts to form a distinct pattern readable to further identify data particular to the test strip.

13. The strip of claim 3, wherein the first and second plurality of electrical strip contacts are positioned to form first and second distinct rows of contacts.

14. The strip of claim 13, wherein the first and second rows of contacts are laterally staggered relative to each other.

15. The strip of claim 1, wherein a resistive element is disposed over at least one of the electrical strip contacts to form part of the distinct pattern readable to identify data particular to the test strip.

16. A method of determining a constituent level within a fluid comprising:

providing a diagnostic test device comprising;

at least one electrically insulating layer;

a conductive pattern formed on the at least one insulating layer including at least one electrode disposed on the at least one insulating layer at a proximal region of the strip, electrical strip contacts disposed on at least one insulating layer at a distal region of the strip, and conductive traces electrically connecting the electrodes to at least some of the electrical strip contacts;

a reagent layer contacting at least a portion of at least one electrode; and

at least one discrete portion of electrical insulating material disposed over at least one of the electrical strip contacts to form a distinct pattern readable to identify data particular to the test strip.

connecting the distal region of the strip to a constituent level meter such that the electrical strip contacts engage with corresponding meter connector contacts;

applying a fluid sample at the reagent layer;

taking a measurement using the plurality of electrodes;

identifying particular data based on the distinct pattern formed at least in part by the electrical insulating material disposed over at least one of the electrical strip contacts; and

calculating the fluid constituent concentration based on the value of measured current and the data.

17. The method of claim 16, wherein each of the plurality of electrodes are individually connected to one contact in a first plurality of electrical strip contacts.

18. The method of claim 17, wherein the conductive pattern at a distal region of the strip includes a second plurality of electrical strip contacts individually electrically isolated to form a discrete set of contacting pads.

19. The method of claim 18, wherein identifying particular data includes reading the distinct pattern through an analog method.

20. The method of claim 18, wherein identifying particular data includes reading the distinct pattern through a digital method.

21. The method of claim 19, wherein providing a diagnostic test device further comprises covering certain contacting pads with the electrical insulating material such that a high impedance path is created and identifying particular data further includes, connecting a preset resistive ladder to a predetermined number of meter connector contacts such that a particular resulting voltage drop, resistance, or current measurement, in a circuit completed through the connection of the contacting pads and corresponding meter connector contacts, signals the meter to access distinct information.

22. The method of claim 20, wherein providing a diagnostic test device further comprises covering certain contacting pads with the electrical insulating material such that a high impedance path is created and identifying particular data includes, reading a meter connection between each contacting pad and a corresponding connector contact as either high impedance or low impedance and assigning a digital value to the connection in a circuit completed through the connection of the contacting pads and corresponding meter connector contacts such that the resulting digital value signals the meter to access distinct information.

23. The method of claim 22, wherein the number of code variations is determined by the expression N=2^P, where P is equal to the number of contacting pads.

24. The method of claim 22, wherein the meter includes an auto-on/wake-up feature provided by a conductive contacting pad and the number of code variations is determined by the expression N=2^P−

1, where P is equal to the number of contacting pads.

25. The method of claim 16, further comprising providing a resistive element over at least one of the electrical strip contacts to form part of the distinct pattern and wherein identifying particular data includes, reading a meter connection between the resistive element and a corresponding connector contact and alerting the meter to access an additional set of data relating to the particular test strip.

26. A method of making a plurality of test strips, said method comprising:

forming a plurality of test strip structures on one sheet, each of said test strip structures including;

(a) a sample chamber;

(b) an electrically insulating layer;

(c) a conductive pattern including a plurality of electrodes formed on said sheet, and a plurality of electrical strip contacts, formed on said sheet, , a portion of which are electrically connected to said plurality of electrodes;

(d) a set of electrical strip contacts individually electrically isolated to form a discrete set of contacting pads formed on said sheet and electrically isolated from said plurality of electrodes; and

(e) at least one discrete portion of electrical insulating material disposed over at least one of the contacting pads to at least partially form a distinct pattern readable to identify data particular to the test strip; and

separating said test strip structures into said plurality of test strips.

27. A method of claim 26, further comprising forming at least one contacting pad to include an auto-on electrical contact.

28. A diagnostic test strip comprising:

at least one electrically insulating layer;

a conductive pattern formed on the at least one insulating layer including at least one electrode disposed on the at least one insulating layer at a proximal region of the strip, electrical strip contacts disposed on at least one insulating layer at a distal region of the strip, and conductive traces electrically connecting the electrodes to at least some of the electrical strip contacts;

a reagent layer contacting at least a portion of at least one electrode; and

wherein each of the electrical strip contacts is selectively coverable with a discrete portion of electrical insulating material to at least partially form a distinct pattern readable to identify data particular to the test strip.

29. The strip of claim 28, further comprising at least one discrete portion of electrical insulating material disposed over at least one of the electrical strip contacts to at least partially form a distinct pattern readable to identify data particular to the test strip.

30. The strip of claim 28, wherein the distinct pattern readable to identify data particular to the test strip comprises an arrangement where none of the electrical strip contacts are covered with electrical insulating material.

31. The strip of claim 29, wherein a resistive element is disposed over at least one of the electrical strip contacts to form part of the distinct pattern readable to identify data particular to the test strip.

32. The strip of claim 28, wherein each of the at least one electrodes is individually connected to one contact in a first plurality of electrical strip contacts.

33. The strip of claim 32, wherein the conductive pattern at the distal region of the strip includes a second plurality of electrical strip contacts.

34. The strip of claim 33, wherein the first and second plurality of electrical strip contacts are positioned to form distinct groups of electrical contacts, the groups being spaced from one another.

35. The strip of claim 33, wherein the second plurality of electrical strip contacts form a discrete set of contacting pads.

36. The strip of claim 29, wherein the insulating material comprises a non-conductive insulating ink.

37. The strip of claim 35, wherein the contacting pads are configured for contact, when inserted into a compatible meter, with a plurality of contacts in a corresponding connector of the meter.

38. A diagnostic test strip comprising:

at least one electrically insulating layer;

a conductive pattern formed on the at least one insulating layer including at least one electrode disposed on the at least one insulating layer at a proximal region of the strip, electrical strip contacts disposed on at least one insulating layer at a distal region of the strip, and conductive traces electrically connecting the electrodes to at least some of the electrical strip contacts;

a reagent layer contacting at least a portion of at least one electrode;

a first plurality of electrical strip contacts comprised of contacts individually connected to an electrode;

a second plurality of electrical strip contacts comprised of the conductive pattern at the distal region of the strip; and

wherein an electrically insulating material separates the first and second plurality of electrical strip contacts.

39. The strip of claim 38, wherein each of the electrical strip contacts comprising the second plurality is selectively coverable with a discrete portion of electrical insulating material to at least partially form a distinct pattern readable to identify data particular to the test strip.

40. The strip of claim 39, further comprising at least one discrete portion of electrical insulating material disposed over at least one of the electrical strip contacts to at least partially form a distinct pattern readable to identify data particular to the test strip.

41. The strip of claim 39, wherein the distinct pattern readable to identify data particular to the test strip comprises an arrangement where none of the electrical strip contacts are covered with electrical insulating material.

42. The strip of claim 40, wherein a resistive element is disposed over at least one of the electrical strip contacts to form part of the distinct pattern readable to identify data particular to the test strip.

43. The strip of claim 38, wherein the second plurality of electrical strip contacts form a discrete set of contacting pads.

44. The strip of claim 38, wherein the insulating material comprises a non-conductive insulating ink.

45. The strip of claim 43, wherein the contacting pads are configured for contact, when inserted into a compatible meter, with a plurality of contacts in a corresponding connector of the meter.

46. A method of making a test strip comprising:

providing at least one electrically insulating layer;

providing a conductive pattern on the at least one insulating layer, the conductive pattern including at least one electrode disposed on the at least one insulating layer at a proximal region of the strip, electrical strip contacts disposed on at least one insulating layer at a distal region of the strip, and conductive traces electrically connecting the electrodes to at least some of the electrical strip contacts;

providing a reagent layer contacting at least a portion of at least one electrode; and

selectively covering at least one of the electrical strip contacts with a discrete portion of electrical insulating material to at least partially form a distinct pattern readable to identify data particular to the test strip.

47. The method of claim 46, further comprising providing a resistive element over at least one of the electrical strip contacts to form part of the distinct pattern readable to identify data particular to the test strip.