EMBEDDED STRIP LOT AUTOCALIBRATION

• US 20150168335A1
• Filed: 03/03/2015
• Published: 06/18/2015
• 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
• Granted Patent: US 9,927,387 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• 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 diagnostic meter comprising:

a connector comprising;

a channel having a proximal end and a distal end for receiving a 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 distinct portions of a contact region of the test strip received in the channel; and

a microprocessor operable with a decoder for decoding a resistance of the contact region of the test strip as information.

2. The diagnostic meter of claim 1, wherein the first plurality of connector contacts are offset laterally relative to the second plurality of connector contacts.

3. The diagnostic meter of claim 1, 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.

4. The diagnostic meter of claim 3, wherein the second plurality of connector contacts includes a grounding connector contact with a proximal edge of the grounding connector contact being positioned distally relative to proximal edges of the remaining connector contacts of the second plurality of connector contacts.

5. The diagnostic meter of claim 1, wherein the connector contacts of the second plurality of connector contacts are longitudinally offset from the connector contacts of the first plurality of connector contacts in a longitudinal direction by a first length, with a connector contact of the second plurality of connector contacts being offset from the connector contacts of the first plurality of connector contacts in the longitudinal direction by a second length greater than the first length.

6. The diagnostic meter of claim 1, wherein the proximal end of the channel is flared out to receive the test strip.

7. The diagnostic meter of claim 1, wherein the connector further comprises tangs extending a predetermined height above a base of the channel and wherein the test strip is received between the base of the channel and the fangs.

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

a 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 conductive 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 readable to identify data particular to the test strip, the machine-readable pattern comprising;

(a) at least one of the electrical strip contacts; and

(b) at least one discrete portion of electrical insulating material disposed over an entire surface of at least one of 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.

9. The system of claim 8, wherein the conductive pattern on the test strip further comprises a set of individually electrically isolated contacting pads provided distal to the electrical strip contacts, and the machine-readable pattern is formed by the contacting pads and at least one discrete portion of a material disposed over at least one of the contacting pads to change a predetermined electrical property of the at least one of the contacting pads.

10. The system of claim 9, 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.

11. The system of claim 10, 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.

12. The system of claim 11, 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.

13. The system of claim 8, 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.

14. The system of claim 8, wherein the first plurality of connector contacts are offset laterally relative to the second plurality of connector contacts.

15. The system of claim 9, wherein the material disposed over the at least one of the contacting pads is an electrically insulating material.

16. The system of claim 9, wherein the contacting pads have a predetermined electrical property of a first value and the material disposed over the at least one contacting pad changes the electrical property of the at least one contacting pad to a second value different from the first value.

17. The system of claim 16, wherein the second value is a non-zero value.

18. 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;

(c) a conductive pattern comprising 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 at least one of said contacts having a predetermined electrical property of a first value;

(e) at least one discrete portion of a material having a predetermined electrical property different than said first value and 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.

19. The method of making a plurality of test strips of claim 18, wherein the predetermined electrical property is a resistance.

20. The method of making a plurality of test strips of claim 18, wherein the predetermined electrical property of the at least one contact varies from strip lot to strip lot.