Systems and methods for point of use evacuation of an array
Inventors
Wernerehl, Aaron • Jones, David E. • Zimmerman, Taylor • Ririe, Kirk M.
Assignees
Biomerieux Inc • Biofire Defense LLC
Publication Number
US-11305276-B2
Publication Date
2022-04-19
Expiration Date
2038-05-23
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Abstract
Systems, methods, and apparatus are provided for evacuating and for filling an array at the point of use.
Core Innovation
The invention relates to novel systems and methods for point-of-use evacuation and filling of a chamber or an array of wells, particularly for use in closed analytical systems. Unlike systems that require pre-evacuation during manufacture and storage under vacuum, these systems allow evacuation (application of vacuum) at the point of use, just prior to, or during the analytical method. The vacuum is applied via a dedicated vacuum channel and port, maintained by a seal, and then fluid is drawn into the evacuated wells by opening an openable seal, such as a frangible or peelable seal, between the fluid reservoir and the array.
The problem addressed is the challenge of reliably filling arrays of wells, such as in closed PCR systems, without introducing bubbles, preventing cross-talk and contamination, and reducing well-to-well variability. Previous methods have relied on positive pressure and venting, which may damage the containers or allow contamination, or on bulk evacuation during manufacture, which requires expensive, robust packaging. Additionally, traditional negative pressure methods are limited by the vapor pressure of the fluid if the vacuum is drawn through the liquid, limiting evacuation efficiency.
The disclosed invention allows for comprehensive air evacuation from the array assembly at the point of use because the vacuum is not drawn through a liquid but through dry wells, allowing for a much stronger vacuum (e.g., down to about 2 millibar). As a result, air bubbles are minimized or eliminated and a consistent volume of fluid is drawn into each well. The design includes a manifold-type channel system allowing all wells to be filled uniformly, and may be incorporated into a pouch or science card comprising multiple layers. The approach reduces the need for costly vacuum packaging, simplifies manufacture, and enables robust, contamination-resistant operation.
Claims Coverage
The independent claim of this patent covers a method with several inventive features related to the point-of-use evacuation and filling of an array within a sample container.
Method for point-of-use evacuation and filling of an array within a sample container
The method involves: 1. Providing a sample container comprising: - A first reaction zone with a fluid reservoir containing a fluid. - A second reaction zone comprising an array assembly with a plurality of wells configured in an array, a vacuum port, a vacuum channel fluidly connected to the vacuum port, and a plurality of channels connecting each well in the array to both the fluid channel and the vacuum port/channel. - A fluid channel extending between the first and second reaction zones and having an openable seal. 2. Drawing a vacuum on the array assembly via the vacuum port and vacuum channel, with the openable seal in a closed state. 3. After evacuation, sealing the vacuum port and/or channel to maintain the vacuum in the plurality of wells and channels, forming an evacuated array. 4. Subsequently, opening the openable seal so that fluid is drawn from the reservoir into the evacuated wells via the plurality of channels.
In summary, the claims are directed to a method for evacuating and filling a well array at point-of-use in a sample container, using a dedicated vacuum channel and an openable seal to control fluid entry, with the vacuum applied prior to introduction of fluid, ensuring efficient and uniform filling.
Stated Advantages
The need to maintain a vacuum during storage, shipping, and handling is eliminated, reducing the cost and complexity of manufacturing and packaging.
The point-of-use evacuation enables a strong vacuum to be applied directly before use, allowing for more thorough removal of air, minimization or elimination of residual bubbles, and more consistent fluid filling of wells.
The system reduces well-to-well variability and cross-talk between wells due to isolation features after filling.
Labor and material cost savings are achieved by avoiding the use of vacuum-sealable containers and robust packaging.
Minimizing or eliminating air bubbles improves the reliability of analytical processes such as PCR.
The array can be evacuated efficiently using relatively simple vacuum devices, such as a piston pump, due to the small volume being evacuated.
Documented Applications
Use in closed systems for performing analytical methods such as multiplex PCR assays, nucleic acid extraction, sample preparation, and amplification of biological samples.
Point-of-use filling of reaction vessels in pouches or science cards for automated diagnostic instruments.
Application in self-contained nucleic acid analysis pouches for detection of pathogens, antimicrobial susceptibility testing, and biological assays.
Use in systems requiring real-time or near real-time preparation of evacuated arrays for reaction filling in analytical workflows.
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