Molecular diagnostic assay system
Inventors
Dority, Douglas B • PHAN, Tien • FROMM, David • Casler, Jr., Richard J. • DICKENS, DUSTIN • Morita, Stuart • Piccini, Matthew
Assignees
Publication Number
US-12280379-B2
Publication Date
2025-04-22
Expiration Date
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Abstract
Improved sub-assemblies and methods of control for use in a diagnostic assay system adapted to receive an assay cartridge are provided herein. Such sub-assemblies include: a brushless DC motor, a door opening/closing mechanism and cartridge loading mechanism, a syringe and valve drive mechanism assembly, a sonication horn, a thermal control device and optical detection/excitation device. Such systems can further include a communications unit configured to wirelessly communicate with a mobile device of a user so as to receive a user input relating to functionality of the system with respect to an assay cartridge received therein and relaying a diagnostic result relating to the assay cartridge to the mobile device.
Core Innovation
The invention provides improved sub-assemblies and methods of control for use in a diagnostic assay system adapted to receive an assay cartridge. Such sub-assemblies include: a brushless DC motor, a door opening/closing mechanism and cartridge loading mechanism, a syringe and valve drive mechanism assembly, a sonication horn, a thermal control device and optical detection/excitation device. Such systems can further include a communications unit configured to wirelessly communicate with a mobile device of a user so as to receive a user input relating to functionality of the system with respect to an assay cartridge received therein and relaying a diagnostic result relating to the assay cartridge to the mobile device.
The background identifies a pressing need created by rapid global spread of contagious pathogens and limited access to health care in remote and under-developed areas and states there exists a pressing need for new and improved diagnostic tools that are highly mobile, capable of performing complex molecular testing to generate rapid, reliable, and accurate diagnostic results regardless of location. The inventors describe a portable, optionally battery-powered molecular diagnostic assay system that performs fully automated molecular diagnostic assays, provides rapid accurate results, and includes secure cloud-based connectivity for conveying diagnostic results to remote reporting systems, thereby facilitating early detection and immediate response to potential epidemics.
Claims Coverage
Two independent claims are identified. The main inventive features extracted from each independent claim are listed below.
Valve drive mechanism with BLDC motor lacking encoder hardware
a valve drive mechanism chassis; a brushless DC (BLDC) motor coupled to the chassis, wherein the BLDC motor comprises a plurality of hall-effect sensors and does not include any encoder hardware; a transmission coupled to BLDC motor; and a valve drive coupled to the transmission, the valve drive configured to rotate positions of a valve body of a removable assay cartridge.
Sinusoidal-signal based valve position determination
wherein position of the valve drive output is determined based on analyzing a sinusoidal signal generated by the hall-effect sensors.
Cartridge-integrity monitoring via BLDC bridge current
wherein the BLDC motor is configured to monitor cartridge integrity based a current measurements of a bridge circuit of the BLDC motor, the current draw measurements being associated with events indicating loss of integrity of the removable assay cartridge.
Commanded rotation using hall-effect sinusoidal encoding
receiving a command to power a brushless DC (BLDC) motor coupled to the chassis to move a valve drive to a particular position, the valve drive being configured to rotate positions of a valve body of a removable assay cartridge, wherein a transmission coupled between the BLDC motor and the valve drive and wherein the BLDC motor comprises a plurality of hall-effect sensors that does not include any encoder hardware; powering the BLDC motor in response to rotate a shaft of the BLDC motor a particular number of turns to move the valve drive to the particular position based on a sinusoidal signal generated by the hall-effect sensors.
Centering protocol using hall-effect sinusoidal signal
wherein the BLDC motor is configured to home and center position of the valve drive output by performing a centering protocol based on the sinusoidal signal generated by the hall-effect sensors.
The independent claims focus on a valve drive system and method that employ a BLDC motor with multiple Hall-effect sensors but without encoder hardware, determine valve position from sinusoidal Hall signals, and monitor cartridge integrity via motor bridge current; the method further includes commanding motor turns based on the sinusoidal signals and performing a centering protocol based on those signals.
Stated Advantages
Portable, optionally battery-powered, small and lightweight diagnostic device permitting complete portable use at any location away from hospitals, laboratories, or drug stores.
Fully automated molecular diagnostic assays capable of detecting multiple pathogens and rapidly obtaining accurate results.
Secure cloud-based connectivity for conveying diagnostic results to remote reporting systems and mobile devices to enable instantaneous data sharing and epidemic monitoring.
Improved sub-assembly performance including use of BLDC motors with Hall-effect sensors and sinusoidal commutation to provide improved resolution and granularity without encoder hardware.
Force-based end-of-travel detection and cartridge integrity sensing derived from monitoring BLDC motor current, reducing or obviating need for additional position or pressure sensors.
Sonication horn control that utilizes phase matching and resonant frequency determination to ensure consistent, robust delivery of ultrasonic energy with reduced size and power requirements.
Thermal control device configurations that increase efficiency and speed of thermo-electric cooler operation to facilitate rapid thermal cycling.
Optical excitation/detection configuration providing improved optical sensitivity and facilitating optical alignment by arranging excitation and detection substantially orthogonal and using relatively low numerical aperture.
Documented Applications
Point-of-care applications including mobile diagnostic centers, in emerging countries, and in physician office labs.
Portable field use in locations where patients may be, away from hospitals, laboratories, or drug stores, including resource-limited settings where electrical power, communication, and traditional health care services may not be routinely available.
Use with disposable assay cartridges for specimen processing including sample preparation, nucleic acid amplification, and analyte detection to detect a variety of analytes including nucleic acid and protein.
Detection of bacteria, viruses, and disease specific markers for pathogenic disease states including Health Associated Infections (MRSA, C. difficile, Vancomycin resistant enterococcus (VRE), Norovirus), Critical Infectious Diseases (MTB/RIF, Flu, RSV, EV), Sexual Health (CT/NG, GBS), oncology (breast or bladder cancer) and Genetics (FII/FV).
Identification of cartridge type via near field communication or other identifiers to apply appropriate assay routines and to link cartridge identity to a sample identifier.
Conveyance of encrypted diagnostic information from the diagnostic device to a remote server and relay of diagnostic results to a user's mobile device for physician or patient reporting.
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