Unitary biochip providing sample-in to results-out processing and methods of manufacture

Inventors

Selden, Richard F. • Tan, Eugene

Assignees

Ande Corp

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 relates to a unitary, stationary, plastic biochip for insertion into an electrophoresis instrument having pneumatic, optical, and in some claims thermal subsystems, and a process controller. The biochip includes at least one pneumatic subsystem interface and at least one optical subsystem interface, and connects a macrofluidic processing subassembly to a fluidic subassembly, a pneumatic subassembly, and a separation and detection subassembly.

The macrofluidic processing subassembly comprises a chamber adapted to receive a sample and preloaded electrophoresis buffer storage chambers, preloaded sieving matrix storage chambers, and preloaded liquid reagent storage chambers with first and second foil seals positioned and configured for communication with separation channels and lyophilized sizing reagent reconstitution chambers. The fluidic subassembly includes a fluidic plate and at least one lyophilized sizing reagent reconstitution chamber preloaded with lyophilized sizing reagent and aligned with the preloaded liquid reagent storage chamber via through holes.

The pneumatic subassembly comprises a pneumatic plate with drive lines that contain only air, and delivers pressure to the top ends of the preloaded storage chambers to cause the first and second foils to burst upon scripted instructions from the process controller. This releases contents into the lyophilized sizing reagent reconstitution chamber to reconstitute the lyophilized sizing reagent, while the separation and detection subassembly includes separation channels having a detection region positioned to send signals to the optical subsystem on the instrument.

Certain claims further recite patterned thermoplastic fluidic and pneumatic plates, a valve subassembly positioned between the fluidic and pneumatic subassemblies, an amplification chamber or thermal cycling chamber adapted to connect to the thermal subsystem, a nucleic acid purification membrane, and lyophilized multiplexed PCR reagent reconstitution. Some claims also recite scripted physical-state change in one or more features of the fluidic, pneumatic, and/or separation and detection subassemblies.

Claims Coverage

The consolidated claim coverage centers on six inventive features across the independent claims: insertable biochip interfaces, macrofluidic preloaded foil-sealed chambers, lyophilized sizing reagent reconstitution, air-only pneumatic drive with scripted instructions, separation and detection with optical signaling, and thermal or workflow-specific claim variants.

The independent claims collectively require an insertable plastic biochip architecture that couples pneumatic air-driven bursting of foil-sealed preloaded chambers and controller-scripted physical state changes to on-chip reconstitution and reagent processing, with separation channels and detection regions that send signals to the optical subsystem. Several independent claims additionally define thermal subsystem integration and nucleic-acid workflow variants.

Stated Advantages

Documented Applications

No documented applications found