Cassette for sterility testing
Inventors
Aviles, Robert C. • Michaud, Devin T. • Browne, Douglas J.
Assignees
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Publication Number
US-10801004-B2
Publication Date
2020-10-13
Expiration Date
Abstract
The invention provides a device for growing cells—referred to as a cassette. The cell culturing device includes a housing that contains a lid having an optically clear window; a fluid distribution channel; a sample injection port fluidically connected to the fluid distribution channel; a base housing a porous media pad; and a media injection port fluidically connected to the media pad. The lid mates to the base to form a sterile seal; the fluid distribution channel is disposed over the media pad, which is viewable through the optical window; and sample fluid introduced into the fluid distribution channel is distributed evenly to the media pad, e.g., via a plurality of channels. The invention also provides kits that include cassettes of the invention and a tube set.
Core Innovation
The invention describes a sterile cell culturing cassette and kit that includes top, bottom, and side walls, a membrane, and an optically clear window in the top wall. The cassette includes a sample injection port and a media injection port, and it is sealed to prevent contamination. Cells from a sample introduced through the sample injection port are filtered through the membrane and retained on the membrane, and the membrane is viewable for imaging through the optically clear window.
The cassette supports cell growth on the membrane by allowing the addition of nutrient media through the media injection port. In the cassette, a sample introduced through the sample injection port flows through the membrane to the media injection port, and the configuration enables imaging of cells retained on the membrane through the optically clear window. Variants are described that include filtration through a membrane and imaging through a window to enable viewing of growth.
An additional embodiment includes a drainage port in the sealed cassette, where the sample introduced through the sample injection port flows through the membrane to the media injection port or the drainage port. The document also describes sterility-testing and microbial enumeration with imaging, including fluorescence imaging on an automated system, with an example showing bacterial growth images and colony correspondence.
Claims Coverage
The document provides two independent claims, each directed to a sealed cell culturing cassette that filters a sample through a membrane, retains cells on the membrane, and supports imaging through an optically clear window. Across the independent claims, the main inventive features revolve around the membrane filtration with imaging window, the paired sample and media injection ports (and, in one claim, a drainage port), and sealed construction to prevent contamination.
Optically clear imaging window for membrane-retained cells
The cassette includes a membrane and an optically clear window in the top wall, wherein the membrane is viewable for imaging through the optically clear window and cells in the sample are retained on the membrane.
Sealed cassette with sample injection port and filtration through membrane
The cassette is sealed to prevent contamination and includes a sample injection port, wherein the cassette allows filtration of a sample through the membrane and cells in the sample are retained on the membrane.
Nutrient media addition via media injection port to support growth
The cassette allows for the addition of nutrient media through the media injection port to support cell growth on the membrane, wherein a sample introduced through the sample injection port flows through the membrane to the media injection port.
Drainage port flow path from membrane to media injection port or drainage port
The cassette includes a drainage port, wherein a sample introduced through the sample injection port flows through the membrane to the media injection port or the drainage port.
Both independent claims broadly cover a sealed, membrane-based cell culturing cassette that retains cells from a filtered sample and enables imaging through an optically clear window, while also enabling nutrient media addition via a media injection port; one independent claim additionally introduces a drainage port to define an alternative flow path.
Stated Advantages
Enables imaging of the membrane and cells retained on the membrane through an optically clear window.
Supports cell growth on the membrane by allowing addition of nutrient media through a media injection port.
Prevents contamination by using a sealed cassette configuration.
Supports sterility testing and microbial enumeration with imaging, including fluorescence imaging, on an automated system.
Documented Applications
Sterility testing and microbial enumeration using imaging on an automated system, including fluorescence imaging and examples showing bacterial growth images and colony correspondence.
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