Systems and method for metering and timing of fluid flow in a point-of-care diagnostic cartridge
Inventors
Carrano, John Jacob • Carrano, John • Plata, Nicole
Assignees
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Publication Number
US-10717080-B2
Publication Date
2020-07-21
Expiration Date
Abstract
A specimen processing cartridge includes a reservoir having a fluid inlet, an elastic diaphragm, and a fluid outlet. The reservoir is operable to receive a volume of liquid from the fluid inlet, and the fluid outlet is positioned along a fluid flow path between the reservoir and a downstream reservoir. The cartridge includes a dissolvable membrane that occludes flow through the fluid outlet when the dissolvable membrane is in a first, undissolved state, and that permits flow from the reservoir to the downstream reservoir when in a second, dissolved state. The elastic diaphragm is operable to pressurize the reservoir upon receiving the volume of liquid when the dissolvable membrane is in the first, undissolved state, and is operable to contract and propel at least a portion of the volume of liquid from the reservoir to the downstream reservoir when the dissolvable membrane is in the second, dissolved state.
Core Innovation
The invention describes a specimen processing cartridge having an intermediate reservoir operable to receive a volume of liquid from a fluid inlet, and an elastic diaphragm positioned to pressurize the intermediate reservoir. A fluid outlet is positioned along a fluid flow path between the fluid inlet and a downstream reservoir, and the outlet is occluded by a dissolvable membrane when the membrane is in a first, undissolved state. When the dissolvable membrane is in a second, dissolved state, the membrane permits flow from the intermediate reservoir to the downstream reservoir.
The cartridge uses the state change of the dissolvable membrane to change the action of the elastic diaphragm. When the membrane is undissolved, applying positive pressure causes expansion of the elastic diaphragm and pressurizes the intermediate reservoir while the outlet remains occluded. After exposure of the dissolvable membrane to the volume of liquid and after a predetermined amount of time lapses, dissolution permits the elastic diaphragm to contract and propel at least a portion of the volume of liquid from the intermediate reservoir to the downstream reservoir.
The cartridge further provides orientation-dependent behavior tied to wicking orientation by positioning the fluid inlet below the fluid outlet and dissolvable membrane in a first orientation opposing a wicking orientation, and positioning the fluid inlet above the fluid outlet in the wicking orientation. In the wicking orientation, the device supports fluid transport across a viewing area via a wicking pad and downstream capillary flow, and may include a capillary plate assay apparatus coupled to the viewing-area fluid path.
Claims Coverage
The independent claims are directed to a specimen processing cartridge with timed metered delivery via an intermediate reservoir, elastic diaphragm, and dissolvable membrane, including orientation-dependent wicking behavior, and a method of implementing a diagnostic process using the same core components and timing/dissolution behavior. Across the claim set, the independent claims emphasize five core inventive features: membrane-state occlusion/dissolution controlling when diaphragm contraction propels liquid, positive pressure expansion while undissolved, inlet/outlet positioning that changes behavior by cartridge orientation relative to wicking, and timed dissolution after exposure to liquid.
Timed occlusion and release by dissolvable membrane states
An intermediate reservoir operable to receive a volume of liquid from a fluid inlet, with a fluid outlet positioned along a fluid flow path between the fluid inlet and a downstream reservoir, and a dissolvable membrane that occludes the fluid outlet when the dissolvable membrane is in a first, undissolved state and permits flow from the intermediate reservoir to the downstream reservoir when in a second, dissolved state.
Diaphragm pressurization and contraction driven by membrane dissolution
An elastic diaphragm operable to pressurize the intermediate reservoir upon receiving the volume of liquid when the dissolvable membrane is in the first, undissolved state, and wherein the elastic diaphragm is operable to contract and propel at least a portion of the volume of liquid from the intermediate reservoir to the downstream reservoir when the dissolvable membrane is in the second, dissolved state.
Orientation-dependent inlet/outlet positioning relative to wicking orientation
Wherein the fluid inlet is positioned below the fluid outlet and dissolvable membrane when the specimen processing cartridge is in a first orientation opposing a wicking orientation, and wherein the fluid inlet is positioned above the fluid outlet when the specimen processing cartridge is placed in the wicking orientation.
Positive pressure expansion while membrane is undissolved, followed by timed dissolution
Delivering a volume of liquid to an intermediate reservoir via a fluid inlet; applying a positive pressure to the intermediate reservoir thereby causing expansion of the elastic diaphragm when the dissolvable membrane is in the first, undissolved state; and exposing the dissolvable membrane to the volume of liquid, wherein the dissolvable membrane dissolves after a predetermined amount of time lapses following exposure to the volume of liquid.
Contraction and propulsion after membrane dissolution to downstream reservoir
Dissolution of the dissolvable membrane permits the elastic diaphragm to contract and propel at least a portion of the volume of liquid from the intermediate reservoir to the downstream reservoir.
Overall, the independent claims cover a diagnostic/specimen processing architecture where a dissolvable membrane in an undissolved state occludes a fluid outlet while an elastic diaphragm pressurizes the intermediate reservoir, and then after a predetermined time and membrane dissolution the membrane permits flow and the diaphragm contracts to propel liquid toward a downstream reservoir. The claims also include inlet/outlet placement that changes behavior based on cartridge orientation relative to wicking orientation.
Stated Advantages
Timed delivery is achieved by dissolving the dissolvable membrane after a predetermined amount of time lapses following exposure to the volume of liquid.
Documented Applications
Implementing a diagnostic process using a diagnostic device that includes an intermediate reservoir, elastic diaphragm, fluid outlet port, and dissolvable membrane to control when liquid flows to a downstream reservoir.
Specimen processing in a point-of-care context using a specimen processing cartridge with downstream wicking and a viewing area for detection.
Capillary plate assay using a capillary plate assay apparatus coupled to a wicking pad and a fluid sink across a viewing area.
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