# US 2019/0170727 A1 · Electronic single use chemical diagnostics device > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2019/0170727 A1 - Document ID: US20190170727A1 - Status: Published application - Kind: A1 - Application number: 16/248,631 - Filed: 2019-01-15 - Published: 2019-06-06 - Earliest claimed: 2016-07-15 - Assignees: Gate Scientific, Inc. - Applicants: Gate Scientific, Inc. - Inventors: Morten Juel JENSEN; Kristian Michael SCABOO - Web page: https://patentgrep.com/patent/US20190170727A1 ## CPC - G01N 33/48792: {Data management, e.g. communication with processing unit (for in vivo diagnostics A61B5/0002; transmission systems for measured values G08C)} - B01L 3/52: {Containers specially adapted for storing or dispensing a reagent (B01L3/02 takes precedence; storing or dispensing test elements G01N33/4875; automated reagent dispensing G01N35/1002)} - B01L 3/545: {for laboratory containers} - G01K 1/14: Supports; Fastening devices; Arrangements for mounting thermometers in particular locations - G01K 13/00: Thermometers specially adapted for specific purposes - G01N 33/48707: {by electrical means (G01N33/49, G01N33/493 take precedence)} - B01L 2200/10: Integrating sample preparation and analysis in single entity, e.g. lab-on-a-chip concept - B01L 2200/141: Preventing contamination, tampering - B01L 2200/146: Employing pressure sensors - B01L 2200/147: Employing temperature sensors - B01L 2200/16: Reagents, handling or storing thereof - B01L 2300/023: Sending and receiving of information, e.g. using Bluetooth® - B01L 2300/024: Storing results with means integrated into the container - B01L 2300/027: Digital display, e.g. LCD, LED - B01L 2300/0663: Whole sensors - B01L 2300/1827: using resistive heater - B01L 2400/0481: squeezing of channels or chambers - G01K 2215/00: Details concerning sensor power supply - G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q) - B01L: CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE - G01K: MEASURING TEMPERATURE; MEASURING QUANTITY OF HEAT; THERMALLY-SENSITIVE ELEMENTS NOT OTHERWISE PROVIDED FOR (radiation pyrometry G01J5/00) ## Abstract An electronic diagnostics device can detect and report environmental conditions from manufacture to use. The device can include a reaction chamber configured to receive a biological sample and contain a reaction with the biological sample. A component of the biological sample can be detected based on the reaction. The device can also include one or more environmental sensors, such as a temperature sensor and a humidity sensor, to detect the environmental conditions. A processor can read data from the environmental sensors and compare the measured conditions to specified ranges. If an environmental parameter falls outside the specified range, the processor can disable the device or communicate to a user that the device should not be used to perform a diagnostic test. ## Claims ### Claim 1 A self-contained electronic diagnostic device for detecting analytes in biological fluids, comprising: a sample inlet area; a sample reaction area with one or more detectors; a battery for providing power to the device; a temperature sensor for measuring temperature; and a microcontroller in data communication with the temperature sensor, and wherein the microcontroller is configured to compare the temperature measured by the temperature sensor with at least one temperature limit; wherein the temperature sensor and microcontroller are configured to monitor the temperature from a time of manufacturing of the device until a time of end-use of the device, and wherein the microcontroller is configured to render the device unusable if the microcontroller determines that the measured temperature crosses the temperature limit. ### Claim 2 (depends on 1) The device of claim 1, wherein the microcontroller is configured to reduce the frequency at which the temperature sensor measures the temperature to save power. ### Claim 3 (depends on 1) A system comprising the device of claim 1 in a vacuum package, and vacuum sensor and/or pressure switch, wherein the vacuum sensor and/or pressure switch are configured to detect if the package is opened, and wherein the microcontroller is configured to render the device unusable is the microcontroller determines that the package has been opened too long before end-use. ### Claim 4 (depends on 3) The system of claim 3, wherein the microcontroller is configured to reduce the frequency at which the pressure sensor and/or pressure switch measure a pressure in the package to save power. ### Claim 5 (depends on 3) The system of claim 3, wherein the vacuum sensor or pressure switch is used to detect the opening of the packaging and thereby activating the measurement process in the device. ### Claim 6 (depends on 1) The device of claim 1, comprising a humidity sensor, wherein the configured to that verifies that the device has not been exposed to excessive humidity until the time of use; and wherein the device is rendered unusable if the humidity limit has been exceeded. ### Claim 7 (depends on 6) The device of claim 6, wherein the humidity sensor is only measured at certain intervals, so as to save power. ### Claim 8 (depends on 1) The device of claim 1, further comprising a tracking element configured for tracking elapsed time from manufacturing of the device until end-use of the device; and wherein the microcontroller is configured to render the device unusable if the elapsed time exceeds an expiration time. ### Claim 9 (depends on 1) The device of claim 1, further comprising a non-volatile memory, and wherein the memory is configured to store calibration factors. ### Claim 10 (depends on 1) The device of claim 1, further comprising an LCD display configured to display measurement results to a user. ### Claim 11 (depends on 10) The device of claim 10, further comprising a non-volatile memory, and wherein the results can be stored in the memory. ### Claim 12 (depends on 10) The device of claim 10, further comprising an antenna-based wireless transmitter configured to transmit the results to a remote system. ### Claim 13 (depends on 10) The device of claim 10, further comprising an optical and/or infra-red wireless transmitter configured to transmit the results to a remote system. ### Claim 14 (depends on 10) The device of claim 10, further comprising an electrical connector configured to transmit the results to a remote system. ### Claim 15 (depends on 1) The device of claim 1, further comprising a closed pouch containing a reagent fluid, and a spring element wherein the is moved or released from a closed pouch by use of a spring element and a resistive element that is coupled to an electrical conducting element by use of meltable material that is solid at room temperature but that melts below the destructive temperature of the other components in connection with the meltable material and where the heating of the resistive element will lead to the melting of the meltable material and whereby a mechanical link will be broken and whereby the breaking of the mechanical link will lead to the spring activation being engaged to move or release reagent fluid. ### Claim 16 (depends on 1) The device of claim 1, wherein multiple processing steps are controlled by use of a spring elements and a resistive elements that are connected to electrical conducting elements by use of meltable material that is solid at room temperature but that melts below the destructive temperature of the other components in connection with the meltable material and where the heating of the resistive element will lead to the melting of the meltable material and whereby mechanical links will be broken and whereby the breaking of the mechanical links will lead to the springs activating several fluid movements at different time points during the reaction. ### Claim 17 (depends on 1) The device of claim 1, wherein the device detects DNA or RNA target fragments corresponding to a genomic sequence ### Claim 18 A device where reagent fluid is moved or released from a closed pouch by use of a spring element and a resistive element that is coupled to an electrical conducting element by use of meltable material that is solid at room temperature but that melts below the destructive temperature of the other components in connection with the meltable material and where the heating of the resistive element will lead to the melting of the meltable material and whereby a mechanical link will be broken and whereby the breaking of the mechanical link will lead to the spring activation being engaged to move or release reagent fluid. ### Claim 19 (depends on 18) The device of claim 18 where the reagent fluid is stored in a closed pouch. ### Claim 20 A device wherein multiple processing steps are controlled by use of a spring elements and a resistive elements that are connected to electrical conducting elements by use of meltable material that is solid at room temperature but that melts below the destructive temperature of the other components in connection with the meltable material and where the heating of the resistive element will lead to the melting of the meltable material and whereby mechanical links will be broken and whereby the breaking of the mechanical links will lead to the springs activating several fluid movements at different time points during the reaction.