Integrated cartridge for sample homogenization and nucleic acid fragmentation
Inventors
Thompson, Greg • McGEE, Zachary • Millirons, Paula
Assignees
Publication Number
US-11918996-B2
Publication Date
2024-03-05
Expiration Date
2040-04-14
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Abstract
Integrated cartridges for sample homogenization, nucleic acid fragmentation, and nucleic acid detection are disclosed herein. The integrated cartridges include a main housing having a sample well and a detection chamber and a sonication feature coupled to and extending outwardly from the main housing. The sonication feature includes a sonication chamber for receiving a sample fluid. A fluidic path directs the sample fluid from the sample well, to the sonication chamber, and to the detection chamber. Systems for use with the integrated cartridges can include sonotrodes with openings for positioning the sonication feature and/or temperature sensors for monitoring the temperature of the sonication feature. Methods include moving the sample fluid from the sample well to the sonication feature, transmitting ultrasonic energy into the sample fluid, moving the sample fluid from the sonication feature to the detection chamber, and performing a nucleic acid detection assay within the detection chamber.
Core Innovation
The invention provides integrated cartridges designed to perform automated and combined sample homogenization, nucleic acid fragmentation, and nucleic acid detection within a single device. The integrated cartridge includes a main housing with a sample well and detection chamber and a sonication feature that extends outwardly from the housing to sonicate sample fluid in a dedicated chamber. A fluidic path guides the sample fluid sequentially from the sample well to the sonication chamber and then to the detection chamber where nucleic acid detection assays are performed.
This system addresses the need for point-of-care nucleic acid detection that integrates preparatory steps, overcoming challenges of current laboratory-based techniques which require separate manual homogenization and fragmentation steps prior to analysis. Existing methods are often labor-intensive, require specialized equipment and trained personnel, and are not suitable for use in field conditions such as epidemic outbreaks or remote locations. The integration enables automation, reduces processing time, facilitates use by medical personnel with different experience levels, and supports portability and affordability in diverse medical settings.
Claims Coverage
The patent includes three independent claims covering the integrated cartridge device and systems related to sample homogenization, nucleic acid fragmentation, and detection, as well as the interaction with sonotrode components and temperature regulation.
Integrated cartridge with outwardly extending sonication feature
An integrated cartridge comprising a main housing with a sample inlet, sample well, and detection chamber, and a sonication feature with a sonication chamber spaced outwardly from the main housing by a coupling including a gasket and at least one conduit, forming a fluidic path that directs sample fluid through the sample well, sonication chamber, and detection chamber.
System with sonication container housing inert beads and temperature control
A system including an integrated cartridge having a generally cylindrical sonication container with inert beads coupled to the main housing and protruding outwardly, a fluidic path directing sample fluid through the container, a temperature sensor monitoring the sonication container, and a processor controlling a cooling and heating mechanism based on temperature readings to maintain predetermined temperature values.
System with elongate sonication feature insertable into sonotrode with temperature monitoring
A system comprising an integrated cartridge with an elongate sonication feature coupled and extending outwardly from the main housing, a fluidic path directing sample fluid through the sonication chamber to the detection chamber, and a sonotrode defining an opening into which the sonication feature is inserted. The sonotrode may contain a coupling fluid well and be coupled to a reader that monitors and controls sonotrode temperature via a temperature sensor.
The inventive features collectively provide a compact, integrated sample processing system combining fluidic sample handling, ultrasonic homogenization and fragmentation using an external sonication feature spaced from the main housing, temperature regulation through sensor feedback and heating/cooling mechanisms, and adaptability for insertion into nucleic acid detection readers, ensuring efficient point-of-care nucleic acid detection.
Stated Advantages
Automation of sample homogenization and nucleic acid fragmentation integrated with nucleic acid detection reduces time and complexity of testing.
Compact, portable, and disposable cartridge design facilitates point-of-care use in diverse settings including healthcare facilities and remote or emergency zones.
Temperature regulation mechanisms preserve sample integrity and maintain consistent sample concentration during sonication.
Spacing of the sonication feature from the main housing limits ultrasonic energy coupling to the housing, improving operation stability.
Documented Applications
Point-of-care nucleic acid testing in healthcare practitioner offices, emergency rooms, urgent care centers, pharmacy clinics, and field locations such as disaster zones, conflict zones, refugee camps, outbreak zones, and remote areas.
Detection and identification of organisms or pathogens, gene expression level determination, and measurement of small RNA levels affecting fields including human and veterinary medicine, food processing, and environmental testing.
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