Diagnostic strip coding system and related methods of use

• US 9,012,232 B2
• Filed: 07/15/2005
• Issued: 04/21/2015
• Est. Priority Date: 07/15/2005
• Status: Active Grant

• Current Assignee: Trividia Health, Inc. (Sinocare, Inc.)
• Original Assignee: Nipro Diagnostics, Inc.
• Inventors: Neel, Gary T., Modzelewski, Brent E., Caban, Allan Javier, Will, Adam Mark, Oti, Carlos
• Primary Examiner(s): Fritchman, Rebecca M
• Application Number:
  US11/181,778
• Publication Number:
  US 20070015286A1
• Time in Patent Office: 3,567 Days
• Field of Search: 436/149, 436/95, 436/514, 422/82.01, 204/428, 204/429, 204/403.01, 205/792, 600/573, 435/14
• 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 electrically insulating layer including at least one electrode disposed on the at least electrically one insulating layer at a proximal region of the strip, electrical strip contacts disposed on the at least one electrically 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 and a set of individually electrically isolated contacting pads provided distal to the electrical strip contacts,

wherein at least one of the contacting pads is a grounding contacting pad configured to establish a common connection to an electrical ground, the grounding contacting pad including a proximal grounding portion and a distal notch portion electrically separated from the grounding portion, wherein a distal edge of the grounding portion of the grounding pad is positioned on the strip proximally relative to distal edges of the remaining contacting pads;

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

a machine-readable pattern readable to identify data particular to the strip, the machine-readable pattern formed by the contacting pads and at least one discrete portion of electrical insulating material disposed over an entire surface of at least one of the contacting pads.

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

3. The strip of claim 2, wherein, during insertion of the test strip into a test meter, the grounding portion is configured to electrically connect to the meter after the remaining electrical strip contacts of the second plurality electrically connect to the meter to prevent premature wake-up of the meter.

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

5. The strip of claim 1, wherein the contacting pads are electrically isolated from the electrodes.

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

7. The strip of claim 1, wherein an electrically insulating region separates the electrical strip contacts from the contacting pads.

8. The strip of claim 1, 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.

9. The strip of claim 1, 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 strip.

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

11. The strip of claim 10, wherein the first and second rows of contacts are laterally staggered relative to each other.

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

13. 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 and a set of individually electrically isolated contacting pads provided distal to the electrical strip contacts,

wherein at least one of the contacting pads is a grounding contacting pad configured to establish a common connection to an electrical ground, the grounding contacting pad including a proximal grounding portion and a distal notch portion electrically separated from the grounding portion, wherein a distal edge of the grounding portion of the grounding pad is positioned on the strip proximally relative to distal edges of the remaining contacting pads;

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 an entire surface of at least one of the contacting pads 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 the entire surface of at least one of the electrical strip contacts; and

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

14. The method of claim 13, wherein each of the plurality of electrodes are individually connected to one contact in a first plurality of electrical strip contacts.

15. The method of claim 14, wherein, during insertion of the test strip into a test meter, the grounding portion is configured to electrically connect to the meter after the remaining electrical strip contacts of the second plurality electrically connect to the meter to prevent premature wake-up of the meter.

16. The method of claim 15, wherein identifying particular data includes reading the distinct pattern through an analog method.

17. The method of claim 15, wherein identifying particular data includes reading the distinct pattern through a digital method.

18. The method of claim 16, 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.

19. The method of claim 17, 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.

20. The method of claim 19, wherein the number of code variations is determined by the expression N=2^P, where P is equal to the number of contacting pads.

21. The method of claim 19, 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.

22. The method of claim 13, 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.

23. A method of making a plurality of test strips, the method comprising:

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

(a) a sample chamber;

(b) an electrically insulating layer;

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

(d) a set of electrical strip contacts individually electrically isolated to form a discrete set of contacting pads formed on the sheet and electrically isolated from the plurality of electrodes, wherein at least one of the contacting pads is a grounding contacting pad configured to establish a common connection to an electrical ground, the grounding contacting pad including a proximal grounding portion and a distal notch portion electrically separated from the grounding portion, wherein a distal edge of the grounding portion of the grounding pad is positioned on the strip proximally relative to distal edges of the remaining contacting pads; and

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

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

24. A method of claim 23, further comprising forming at least one contacting pad to include an auto-on electrical contact.

25. A diagnostic test strip, comprising:

at least one electrically insulating layer;

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

a first plurality of electrical strip contacts comprised of contacts individually connected to each of the electrodes;

a code pattern comprising a second plurality of electrical strip contacts comprised of the conductive pattern at the distal region of the strip, the second plurality of electrical strip contacts electrically insulated from the electrodes, wherein at least one of the second plurality of electrical strip contacts is a grounding contacting pad configured to establish a common connection to an electrical ground, the grounding contacting pad including a proximal grounding portion and a distal notch portion electrically separated from the grounding portion, wherein a distal edge of the grounding portion of the grounding pad is positioned on the strip proximally relative to distal edges of the remaining electrical strip contacts of the second plurality; and

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

26. The strip of claim 25, 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.

27. The strip of claim 26, 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.

28. The strip of claim 25, 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.

29. The strip of claim 25, wherein the second plurality of electrical strip contacts form a discrete set of contacting pads.

30. The strip of claim 25, wherein the insulating material comprises a non-conductive insulating ink.

31. The strip of claim 29, 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.

34. The strip of claim 25, wherein, during insertion of the test strip into a test meter, the grounding portion is configured to electrically connect to the meter after the remaining electrical strip contacts of the second plurality electrically connect to the meter to prevent premature wake-up of the meter.

32. 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 and a set of individually electrically isolated contacting pads provided distal to the electrical strip contacts, wherein at least one of the contacting pads is a grounding contacting pad configured to establish a common connection to an electrical ground, the grounding contacting pad including a proximal grounding portion and a distal notch portion electrically separated from the grounding portion, wherein a distal edge of the grounding portion of the grounding pad is positioned on the strip proximally relative to distal edges of the remaining contacting pads;

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

selectively covering an entire surface of 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.

33. The method of claim 32, 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.