Embedded strip lot autocalibration

• US 10,527,575 B2
• Filed: 02/15/2018
• Issued: 01/07/2020
• Est. Priority Date: 07/15/2005
• Status: Active Grant

• Current Assignee: Trividia Health, Inc. (Sinocare, Inc.)
• Original Assignee: Trividia Health, Inc. (Sinocare, Inc.)
• Inventors: Neel, Gary T., Modzelewski, Brent E., Caban, Allan Javier, Will, Adam Mark, Oti, Carlos
• Primary Examiner(s): Noguerola, Alexander S
• Application Number:
  US15/897,548
• Publication Number:
  US 20180172616A1
• Time in Patent Office: 691 Days
• CPC Class Codes: C12Q 1/54 involving glucose or galactose
• CPC Class Codes: G01N 2035/00851 process control parameters
• 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
• CPC Class Codes: Y10T 29/49117 Conductor or circuit manufacturing
• CPC Class Codes: Y10T 29/49155 Manufacturing circuit on or in base

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 test strip meter may provide a predetermined varying resistance on one strip or a plurality of varying resistances from strip lot to strip lot.

Claims

1. A test strip for measuring a body fluid constituent comprising:

at least one electrically insulating layer with a proximal region and a distal region;

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 the proximal region of the strip, electrical strip contacts disposed on the at least one insulating layer at a conductive region at the distal region of the test 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

a machine-readable pattern formed on the at least one insulating layer and being readable to identify data particular to the test strip, the machine-readable pattern comprising a plurality of contacting pads with each contacting pad of the plurality of contacting pads having either a first or second predetermined electrical value, the first and second predetermined value being different from one another;

wherein the contacting pads are disposed distal of the electrical strip contacts and are electrically separated from the electrical strip contacts, and

wherein at least one of the contacting pads is configured to establish a common connection to ground or a voltage source configured to reverse polarity and is positioned to ensure a connection between the remaining contacting pads and the electrical strip contacts before the common connection to ground or the voltage source is established.

2. The test strip of claim 1, wherein an electrically insulating material over the at least one of the contacting pads provides the at least one of the contacting pads the second predetermined value.

3. The test strip of claim 1, wherein the second value is a non-zero value.

4. A system for measuring a body fluid constituent comprising:

a test strip comprising;

at least one electrically insulating layer with a proximal region and a distal region;

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 the proximal region of the strip, electrical strip contacts disposed on the at least one insulating layer at a conductive region at the distal region of the test 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

a machine-readable pattern formed on the at least one insulating layer and being readable to identify data particular to the test strip, the machine-readable pattern comprising a plurality of contacting pads with each contacting pad of the plurality of contacting pads having either a first or second predetermined electrical value, the first and second predetermined value being different from one another;

wherein the contacting pads are disposed distal of the electrical strip contacts and are electrically separated from the electrical strip contacts, and

a diagnostic meter comprising;

a connector comprising a channel having a proximal end and a distal end configured to receive the test strip;

a first plurality of connector contacts and a second plurality of connector contacts disposed in the channel, the first plurality of connector contacts and the second plurality of connector contacts being positioned in the channel to contact the electrical strip contacts located in distinct portions of the contact region of the test strip, and a microprocessor operable with a decoder for decoding a resistance of the electrical strip contacts as information

wherein (A) one of the connector contacts is configured to establish a common connection to ground or a voltage source configured to reverse polarity and is positioned relative to the remaining connector contacts to ensure a connection between the contacting pads of the test strip and the remaining connector contacts before the common connection to ground or the voltage source is established, or (B) at least one of the contacting pads is configured to establish a common connection to ground or a voltage source configured to reverse polarity and is positioned to ensure a connection between the remaining contacting pads and the electrical strip contacts before the common connection to ground or the voltage source is established.

5. The system of claim 4, wherein an electrically insulating material over the at least one of the contacting pads provides the at least one of the contacting pads the second predetermined value.

6. The system of claim 4, wherein the second value is a non-zero value.

7. The system of claim 4, wherein the first plurality of connector contacts are positioned in the channel to contact the electrical strip contacts and the second plurality of connector contacts are positioned in the channel distally of the first plurality of the connector contacts to contact the contacting pads.

8. The system of claim 4, wherein the second plurality of connector contacts includes a grounding connector contact configured to contact a grounding contacting pad of the contacting pad, wherein a proximal edge of the grounding connector contact is positioned distally relative to proximal edges of the remaining connector contacts of the second plurality of connector contacts.

9. The system of claim 4, wherein, when the test strip is inserted into the channel from the proximal end toward the distal end, the grounding connector contacts the grounding contacting pad to activate a completion of a circuit to wake-up the meter by providing a signal to power up the meter from a low-power sleep mode.

10. The system of claim 4, wherein the connector contacts of the first plurality of connector contacts are arranged in a first row and the connector contacts of the second plurality of connector contacts are arranged in a second row distal to the first row.

11. The system of claim 4, wherein the first plurality of connector contacts are offset laterally relative to the second plurality of connector contacts.

12. A method of making a plurality of test strips, the 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 with a proximal region and a distal region;

(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 distally of and electrically isolated from said plurality of electrodes, each contacting pad of the set of contacting pads having either a first or second predetermined electrical value, the first and second predetermined value being different from one another, the first and second predetermined electrical values associated with the contacting pads forming a machine-readable pattern readable to identify data particular to the test strip, wherein at least one of the contacting pads is configured to establish a common connection to ground or a voltage source configured to reverse polarity and is positioned to ensure a connection between the remaining contacting pads and the electrical strip contacts before the common connection to ground or the voltage source is established; and

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

13. The method of claim 12, wherein the predetermined electrical values are a resistance.

14. The method of claim 12, wherein the predetermined electrical value of the at least one contact varies from strip lot to strip lot.

15. The method of claim 12, wherein an electrically insulating material over the at least one of the contacting pads provides the at least one of the contacting pads the second predetermined value.

16. The method of claim 12, wherein the second value is a non-zero value.