Unitary biochip providing sample-in to results-out processing and methods of manufacture
Inventors
Selden, Richard F. • Tan, Eugene
Assignees
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Publication Number
US-11612894-B2
Publication Date
2023-03-28
Expiration Date
Abstract
A biochip for the integration of all steps in a complex process from the insertion of a sample to the generation of a result, performed without operator intervention includes microfluidic and macrofluidic features that are acted on by instrument subsystems in a series of scripted processing steps. Methods for fabricating these complex biochips of high feature density by injection molding are also provided.
Core Innovation
The invention describes a unitary biochip configured for conducting multiplexed PCR analysis of at least two nucleic acids while used with an instrument that includes a process controller, a pneumatic subsystem, and a thermal cycling subsystem. The biochip includes an integrated macrofluidic block and corresponding pneumatic and fluidics subassemblies that support receiving a nucleic-acid sample and generating multiplex PCR mix solution for amplification.
A macrofluidic block includes preloaded lysis reagent solution storage chambers sealed by a first foil seal bonded to the bottom end and a second foil seal bonded to the top end. The biochip provides a pneumatic subsystem interface aligned with a fluidics subassembly via a through hole, and a pneumatic subassembly that delivers pneumatic pressure to the top ends of the chambers, thereby causing the foils to burst under scripted controls from the process controller and releasing the contents into the flow path.
The fluidics subassembly includes at least one reconstitution chamber preloaded with lyophilized multiplexed PCR reagent in fluid communication with the lysis solution storage chamber, and at least one thermal cycling chamber positioned in thermal communication with the instrument. The generated PCR mix solution travels along the primary flow path to the thermal cycling chamber, with multiplexed PCR analysis supported by controlled reconstitution and scripted automated process steps.
Claims Coverage
The document provides one independent claim directed to a unitary biochip for multiplexed PCR analysis of at least two nucleic acids integrated with instrument pneumatic and thermal cycling subsystems. The main inventive features are centered on sealed preloaded lysis reagent chambers with burst driven by an instrument pneumatic subsystem, reconstitution of a lyophilized multiplexed PCR reagent, and routing of the resulting PCR mix solution through thermal cycling chambers under scripted controls.
Unitary biochip with instrument process controller, pneumatic subsystem, and thermal cycling subsystem
A unitary biochip for conducting multiplexed PCR analysis of at least two nucleic acids, used with an instrument comprising a process controller, a pneumatic subsystem, and a thermal cycling subsystem, where the biochip comprises a macrofluidic block, a pneumatic subassembly, a fluidics subassembly, and a thermal cycling subassembly positioned in thermal communication with the instrument.
Sealed preloaded lysis reagent chambers with foil bursting
A macrofluidic block that includes at least one preloaded lysis reagent solution storage chamber sealed by a first foil seal bonded to the bottom end and a second foil seal bonded to the top end, where the biochip includes a pneumatic subsystem interface configured to receive pressure from the instrument aligned with the pneumatic plate via a through hole.
Pneumatic plate drive lines delivering pressure to burst foils under scripted controls
A pneumatic subassembly having a pneumatic plate comprising one or a plurality of drive lines that contain only air, aligned with a fluidics assembly via through holes for each preloaded lysis reagent storage chamber, and configured to receive pressure from the instrument and deliver it to the top ends to cause the first and second foils to burst and release the contents upon scripted controls from the process controller.
Reconstitution of lyophilized multiplexed PCR reagent to generate PCR mix solution
A fluidics subassembly comprising at least one reconstitution chamber preloaded with lyophilized multiplexed PCR reagent in fluid communication with the lysis solution storage chamber, and configured so that release of lysate causes the lysate to reconstitute the lyophilized multiplexed PCR reagent to generate PCR mix solution.
Primary flow path routing PCR mix to thermal cycling chamber
A fluidics subassembly that includes at least one thermal cycling chamber and a primary flow path in fluid communication with the reconstitution chamber and the thermal cycling chamber, such that PCR mix solution travels along the primary flow path to the thermal cycling chamber for amplification.
Overall, the claim coverage centers on an integrated unitary biochip that uses instrument-controlled pneumatic pressure to burst sealed preloaded lysis reagent chambers, reconstitutes a lyophilized multiplexed PCR reagent to form PCR mix solution, and routes that PCR mix solution through thermal cycling chambers under scripted process-controller control.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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