Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Publication Number
US-10730041-B2
Publication Date
2020-08-04
Expiration Date
Abstract
Fluidic devices and related methods are generally provided. The fluidic devices described herein may be useful, for example, for diagnostic purposes (e.g., detection of the presence of one or more disease causing bacteria in a patient sample). Unlike certain existing fluidic devices for diagnostic purposes, the fluidic devices and methods described herein may be useful for detecting the presence of numerous disease causing bacteria in a patient sample substantially simultaneously (e.g., in parallel). In some embodiments, the fluidic devices and methods described herein provide highly sensitive detection of microbes in relatively large fluidic samples (e.g., between 0.5 mL and about 5 mL), as compared to certain existing fluidic detection (e.g., microfluidic) devices and methods. In an exemplary embodiment, increased detection sensitivity of microbial pathogens present in a patient sample (e.g., blood) is performed by selectively removing human nucleic acid prior to sensitive detection of microbial infection. In some embodiments, the fluidic device allows for the identification of microbial pathogens directly from unprocessed blood without having to conduct blood culturing processes.
Core Innovation
The invention relates to an integrated automated fluidic device for diagnostic microbiology in which a sample inlet is connected to a fluidic channel that is in fluidic communication with sequential processing regions. The workflow includes a first lysis region containing one or more non-ionic detergents that selectively lyses eukaryote cells, followed by a first isolation region, and then a second lysis region containing one or more reagents that lyses microbial cells, followed by a second isolation region.
A reaction region is provided downstream of the second isolation region, and an amplification region is provided downstream of the reaction region. The device includes a processing chamber in fluidic communication with the amplification region, where the processing chamber contains a duplex DNA Invading Artificial Nucleic Acid (DIANA) for detecting microbial genomic material from one or more microbial cells.
In related embodiments, the processing chamber contains a plurality of duplex DIANAs configured for detecting microbial genomic material from one or more microbial cells, where each duplex DIANA targets one or more amplicons from a specific microorganism or group of microorganisms. The DIANA configuration may include a peptide nucleic acid, a locked nucleic acid, or a bridged nucleic acid.
The invention also provides a mixing system within a reaction region, including a channel, a first valve that reversibly opens and closes, a fluidic reservoir connected to the channel, an outlet channel in fluidic communication with the fluidic reservoir, and a second valve that reversibly opens and closes. Adjacent to the fluidic reservoir is a cover that encloses the fluidic reservoir, where the cover comprises a semipermeable membrane that is hydrophobic, with an air permeability within specified ranges.
Claims Coverage
The document contains two independent claims. Across these independent claims, the inventive features focus on a multi-region microfluidic workflow for sequential eukaryote cell lysis, microbial cell lysis, isolation, reaction, amplification, and DIANA-based detection, and on a reaction-region mixing system combined with a hydrophobic semipermeable membrane cover with defined gas-transport properties.
Multi-region microfluidic lysis-to-detection workflow with DIANA processing chamber
A fluidic device with a sample inlet and a fluidic channel in fluidic communication with the sample inlet, a first lysis region containing one or more non-ionic detergents that selectively lyses eukaryote cells, a first isolation region, a second lysis region containing one or more reagents that lyses microbial cells, a second isolation region, at least one reaction region, an amplification region, and a processing chamber containing a duplex DNA Invading Artificial Nucleic Acid (DIANA) for detecting microbial genomic material from one or more microbial cells.
Reaction-region mixing system with two reversible valves and hydrophobic semipermeable membrane cover
A fluidic device with a sample inlet and a fluidic channel, a first lysis region with one or more detergents selectively lysing eukaryote cells, a first isolation region, a second lysis region with one or more reagents lysing microbial cells, a second isolation region, a reaction region comprising a mixing system including a channel, a first valve reversibly opening and closing, a fluidic reservoir connected to the channel, an outlet channel, and a second valve associated with the outlet channel and reversibly opening and closing, and a cover adjacent to the fluidic reservoir enclosing the reservoir, where the cover is a semipermeable membrane that is hydrophobic and has specified air permeability; an amplification region and a processing chamber in fluidic communication with at least one of the reaction region and/or the amplification region.
Independent claim coverage is centered on a sequential fluidic device workflow culminating in a DIANA-containing processing chamber for microbial genomic material detection, with additional independent-claim scope for a reaction-region mixing system using two reversibly operable valves and a hydrophobic semipermeable membrane cover having specified air permeability.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
Interested in licensing this patent?