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

Partus Diagnostics LLC • Paratus Diagnostics LLC

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Publication Number

US-10449538-B1

Patent

Publication Date

2019-10-22

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 relates to a specimen processing cartridge and diagnostic process in which a diagnostic device includes an intermediate reservoir having a fluid inlet, an elastic diaphragm, and a fluid outlet positioned along a fluid flow path between the intermediate reservoir and a downstream reservoir. The intermediate reservoir receives a volume of liquid from the fluid inlet and is positively pressurized such that the elastic diaphragm expands and contracts in response to the state of a dissolvable membrane.

The dissolvable membrane occludes the fluid outlet when in a first, undissolved state and permits flow from the intermediate reservoir to the downstream reservoir when in a second, dissolved state. The elastic diaphragm pressurizes the intermediate reservoir when the dissolvable membrane is in the first, undissolved state and contracts to propel at least a portion of the volume of liquid toward the downstream reservoir when the dissolvable membrane is in the second, dissolved state.

At least one storage reservoir is positioned within a corresponding actuation port and is operable to receive a corresponding actuation post positioned on an external device. Insertion of the diagnostic device into a mating adaptor applies hydraulic force to the storage reservoir(s), propelling first and second liquids into the intermediate reservoir so that the volume of liquid comprises a product of the first liquid and the second liquid.

The downstream portion of the fluid path is configured to move liquid across a viewing area and to a fluid sink via a wicking pad. In a wicking orientation, a first portion of the wicking pad is positioned below the viewing area, so that liquid received from the downstream reservoir can be received by the wicking pad and flow across the viewing area.

Claims Coverage

The independent claims cover four inventive features: an intermediate reservoir controlled by an elastic diaphragm and a dissolvable membrane, hydraulic actuation of storage reservoirs into the intermediate reservoir, a specimen receiving chamber with a viewing-area fluid flow path and wicking pad, and timed dissolvable membrane dissolution controlling liquid delivery in a diagnostic process.

Intermediate reservoir with elastic diaphragm and dissolvable membrane controlled outlet

An intermediate reservoir having a fluid inlet, an elastic diaphragm, and a fluid outlet positioned along a fluid flow path between the intermediate reservoir and a downstream reservoir, together with a dissolvable membrane that occludes the fluid outlet when in a first, undissolved state and permits flow from the intermediate reservoir to the downstream reservoir when in a second, dissolved state, where the elastic diaphragm is operable to pressurize the intermediate reservoir when the dissolvable membrane is in the first, undissolved state and contract to 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.

Hydraulic actuation of storage reservoirs into intermediate reservoir

At least one storage reservoir positioned within a corresponding actuation port to receive a corresponding actuation post from an external device, wherein applying hydraulic force to each storage reservoir upon insertion of the actuation post into the actuation port propels a first liquid and a second liquid into the intermediate reservoir so that the volume of liquid comprises a product of the first liquid and the second liquid.

Specimen receiving chamber coupled to collection liquid reservoir and viewing-area fluid flow path with wicking pad

A collection liquid reservoir operable to store a sample collection liquid and being coupled to an actuator, a specimen receiving chamber operable to receive a sample collection device and fluidly coupled to the collection liquid reservoir to receive the sample collection liquid upon actuation of the actuator, a fluid coupling extending from the specimen receiving chamber to the downstream reservoir, and a fluid flow path extending from the downstream reservoir across a viewing area and to a fluid sink, wherein the fluid flow path comprises a wicking pad positioned below the viewing area when the specimen processing cartridge is in a wicking orientation.

Timed dissolvable membrane dissolution controlling elastic diaphragm pressurization and release in a diagnostic process

A method implementing a diagnostic process delivering a volume of liquid to an intermediate reservoir via a fluid inlet of a diagnostic device comprising an elastic diaphragm within a boundary of the intermediate reservoir, a fluid outlet port along a fluid flow path to a downstream reservoir, at least one storage reservoir within an actuation port, and a dissolvable membrane that occludes the fluid flow path when in a first, undissolved state and permits flow when in a second, dissolved state, including inserting the diagnostic device into a mating adaptor with actuation post(s), exposing the dissolvable membrane to the volume of liquid so that the dissolvable membrane dissolves after a predetermined amount of time lapses following exposure, and where 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.

Across the independent claims, the inventive concept is a specimen processing/diagnostic cartridge in which an elastic diaphragm pressurizes an intermediate reservoir while a dissolvable membrane occludes a fluid outlet, and then membrane dissolution after exposing to a delivered volume permits the diaphragm to contract and propel liquid to a downstream reservoir. Actuation of storage reservoirs by inserting a mating adaptor provides hydraulic force to meter and combine liquids into the intermediate reservoir, and downstream fluid handling includes a fluid flow path across a viewing area and to a fluid sink with a wicking pad positioned relative to the viewing area.

Stated Advantages

Not explicitly described in patent.

Documented Applications

Not explicitly described in patent.

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