Apparatus for diagnostic meter strip control and identification
Inventors
Modzelewski, Brent E. • Leone, Steven V. • Combs, Bradley
Assignees
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Publication Number
US-10416148-B2
Publication Date
2019-09-17
Expiration Date
Abstract
A system for measuring a property of a sample in a liquid which includes a test strip and a meter is provided. Some embodiments relate to a diagnostic test strip for collecting a sample, the strip having a plurality of electrodes for measuring a property of the sample, and the strip having a control circuit at a distal region of the strip, the control circuit configured to communicate with a controller of a meter, the control circuit including an embedded temperature sensor, a memory for lot coding and authentication of the test strip, and an inhibit logic for inhibiting the test from being used more than once; and a diagnostic meter for receiving the test strip, the meter having a controller programmed to communicate with the control circuit.
Core Innovation
The invention describes an electrochemical diagnostic test strip that includes a substrate carrying a plurality of electrodes disposed at a proximal region for measuring a property of a sample. An integrated control circuit is disposed at a distal region of the substrate and is connected to the plurality of electrodes, and the integrated control circuit is configured to communicate with a controller of a meter and to control a plurality of peripherals.
The integrated control circuit includes an embedded temperature sensor and controls measurement-related functionality through communication with the meter controller. The integrated control circuit is also configured to control memory for lot coding and authentication of the test strip, and includes inhibit logic for inhibiting the test strip from being used after removal of the test strip from the meter.
The integrated control circuit is connected to ground and communicates with the controller of the meter via a one wire interface. The memory includes non-volatile storage such as a non-volatile string of bits for lot coding and a non-volatile string of bits for authentication password, and the test strip further includes electrical strip contacts and conductive traces electrically connecting the plurality of electrodes to the contacts, with an insulation layer and a conductive pattern on the substrate.
Claims Coverage
The document includes two independent claims. Together, they define a distal integrated control circuit with a one wire interface, embedded temperature sensing, non-volatile lot coding and authentication memory, and inhibit logic that disables or inhibits the strip after removal and/or when temperature is outside a pre-selected range, with a thermal fuse and one-time-use type disabling features.
Proximal electrodes and distal integrated control circuit
A test strip with a substrate; a plurality of electrodes disposed at a proximal region of the substrate for measuring a property of a sample; and an integrated control circuit disposed at a distal region of the substrate, the integrated control circuit being connected to the plurality of electrodes and configured to communicate with a controller of a meter.
One wire interface with ground-connected integrated control circuit
The integrated control circuit is connected to ground and configured to communicate with the controller of the meter via a one wire interface.
Embedded temperature sensor, lot coding/authentication memory, and inhibit logic
The integrated control circuit is configured to control a plurality of peripherals comprising an embedded temperature sensor, a memory for lot coding and authentication of the test strip, and an inhibit logic for inhibiting the test strip from being used after removal from the meter.
Temperature-measuring integrated control circuit with temperature-range inhibition
A diagnostic test strip in which the integrated control circuit is configured to measure a temperature of the test strip and programmed to inhibit the test strip when the temperature is outside a pre-selected range of temperatures.
Thermal fuse and inhibit logic to disable more than once
The integrated control circuit is configured to control peripherals comprising an embedded temperature sensor, a thermal fuse to disable the test strip if it encounters a temperature outside a pre-selected range, a memory for lot coding and authentication of the test strip, and an inhibit logic for inhibiting the test strip from being used more than once.
Electrical strip contacts and conductive traces from electrodes
The test strip further includes electrical strip contacts at a distal region on the substrate, with conductive traces electrically connecting the plurality of electrodes to at least some of the electrical strip contacts.
Overall, the claim coverage centers on a test strip architecture that separates proximal electrode sensing from a distal integrated control circuit that communicates with a meter via a one wire interface. The integrated control circuit controls embedded temperature sensing, non-volatile memory for lot coding and authentication, and inhibit logic that prevents use after removal and/or inhibits operation when temperature is outside a pre-selected range, including thermal-fuse disabling and more-than-once inhibition, and it includes distal electrical contacts connected by conductive traces.
Stated Advantages
Documented Applications
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