Apparatus for diagnostic meter strip control and identification
Inventors
Modzelewski, Brent E. • Leone, Steven V. • Combs, Bradley
Assignees
Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Publication Number
US-9588101-B2
Publication Date
2017-03-07
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 provides an electrochemical diagnostic system for measuring a property of a sample in a liquid. A diagnostic test strip collects the sample and includes a plurality of electrodes for measuring the property, together with a control circuit at a distal region of the strip configured to communicate with a controller of a meter.
The control circuit includes an embedded temperature sensor, a memory for lot coding and authentication of the test strip, and inhibit logic for inhibiting the test strip from being used after removal from the meter. The control circuit runs diagnostics on the test strip, including reading autocode information, identifying the test strip, authenticating the test strip, calibrating the analog front end, measuring a temperature of the test strip, and validating electrodes on the test strip.
In embodiments, the system includes embedded sensors such as a humidity sensor, and humidity and temperature measurements are used to coordinate measurement or inhibit use when environmental conditions are outside pre-selected ranges of temperatures or humidity. The inhibit logic can include a fuse such as a digital fuse and a thermal fuse.
Claims Coverage
The independent claims cover five main inventive features centered on a distal-region control circuit in a diagnostic test strip that communicates with a meter controller.
Liquid-sample diagnostic system with distal control circuit
A diagnostic test strip for collecting a sample with plurality of electrodes and a control circuit at a distal region configured to communicate with a controller of a meter, the control circuit including an embedded temperature sensor, a memory for lot coding and authentication, and an inhibit logic for inhibiting the test strip from being used after removal from the meter; and a diagnostic meter receiving the test strip with a controller programmed to communicate with the control circuit.
Humidity-enabled liquid-sample diagnostic system with fuse inhibition
A diagnostic system with a diagnostic test strip having an embedded humidity sensor and a control circuit at a distal region communicating with a controller of a meter, the control circuit including embedded temperature sensor, memory for lot coding and authentication, and an inhibit logic including a fuse; and a diagnostic meter whose controller communicates with the humidity circuit and with the control circuit.
Diagnostic test strip structure with insulating layer, electrodes, reagent layer, and distal control circuit
A diagnostic test strip comprising an electrically insulating layer with a conductive pattern including plurality of electrodes at a proximal region; electrical strip contacts at a distal region with conductive traces connecting the electrodes to at least some of the contacts; a reagent layer contacting at least a portion of at least one electrode; and a control circuit disposed at the distal region connected to the electrodes and configured to communicate with a controller of a meter, the control circuit including an embedded temperature sensor, memory for lot coding and authentication, and an inhibit logic including a fuse.
Glucose measurement method using resistance and distal control diagnostics
A method for measuring a concentration of glucose in a blood sample using a diagnostic test strip and meter, where the control circuit runs diagnostics including reading autocode information, identifying the test strip, authenticating the test strip, calibrating the analog front end, measuring a temperature, and validating electrodes; a blood sample is applied; a resistance of the blood sample is measured and used to determine glucose concentration; and the control circuit inhibits the test strip from being used again.
Temperature-range reuse inhibition using thermal fuse
A system for measuring a property of a sample in a liquid with a diagnostic test strip having a distal-region control circuit including an embedded temperature sensor, memory for lot coding and authentication, and an inhibit logic for inhibiting use more than once; and a diagnostic meter with a controller that communicates with the control circuit; where the control circuit measures test-strip temperature and inhibits the test strip when the temperature is outside a pre-selected range, and the control circuit includes a thermal fuse.
The claims consistently center on a distal-region control circuit in an electrode-equipped diagnostic test strip that communicates with a meter controller. The control circuit includes embedded temperature sensing, lot coding and authentication memory, and inhibit logic, including a fuse or thermal fuse, to prevent reuse and to inhibit use based on measured temperature conditions. Additional coverage includes embedded humidity sensing and diagnostic test strip structure with insulating layer, electrode pattern, reagent layer, distal contacts, and traces.
Stated Advantages
Inhibits the test strip from being used after removal from the meter.
Inhibits the test strip from being used again.
Authenticates the test strip using lot coding and authentication memory.
Enables calibration of the analog front end and validation of electrodes through control-circuit diagnostics.
Supports temperature measurement and inhibition based on temperature being outside a pre-selected range.
Optionally supports humidity-based coordination of measurement through an embedded humidity sensor.
Documented Applications
Measuring a concentration of glucose in a blood sample using an electrochemical diagnostic system.
Measuring a property of a sample in a liquid using an electrochemical diagnostic test strip and meter.
Inhibiting strip use when environmental conditions, including temperature outside a pre-selected range and optionally humidity, are detected through embedded sensors.
Interested in licensing this patent?