Pinch to open sample collection device

Inventors

Johnson, Brandon T.

Assignees

Nightingale Health Oyj

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Publication Number

US-11358139-B2

Patent

Publication Date

2022-06-14

Expiration Date


Abstract

A blood sample collection and/or storage device includes a two-piece housing that encompasses a port at which a fingertip blood sample is collected. After the sample is taken, the two-piece housing is moved to a closed position to protect the sample for storage and optionally process the sample within the housing. The housing may also be opened to access the stored sample for further processing.

Core Innovation

An apparatus collects a biological sample using a housing configurable from an open position to a closed position. A sample collection port is configured to collect the biological sample when the housing is in the open position, and one or more fluid pathways draw in the biological sample from the collection port. A membrane is disposed within the housing, and a portion of the membrane is configured to separate cellular material from the biological sample when the biological sample is introduced onto the membrane.

The apparatus includes a preservative in the membrane and a structural member disposed within the housing configured to hold the membrane within the housing. A mechanical actuator dispenses the biological sample from the one or more fluid pathways onto the membrane when the housing is moved from the open position to the closed position. A desiccant is provided in the apparatus, and the housing is further configured to allow the fluid pathways to be viewed when the housing is in the open position while the sample collection port is inaccessible when the housing is in the closed position.

The one or more fluid pathways comprise a capillary tube, and a reagent is included by being coated on an inner surface of the capillary tube or comprised in the membrane. The mechanical actuator comprises one or more plungers configured to be inserted into the one or more fluid pathways, so the sample is dispensed onto the membrane during the open-to-closed movement.

Claims Coverage

The document provides coverage centered on a single independent apparatus claim, supported by multiple dependent claim refinements. Across the independent claim, the inventive concept contains approximately nine core inventive features: open/closed housing with an inaccessible collection port in the closed position, visible fluid pathways in the open position, a membrane with a preservative for cellular separation, a mechanical actuator that dispenses sample from capillary pathways onto the membrane during closing, and inclusion of a desiccant, a capillary-tube fluid pathway, a reagent in the capillary tube or membrane, and plungers inserted into the capillary tubes.

Open/close housing with inaccessible collection port

A housing configurable from an open position to a closed position; the sample collection port is inaccessible when the housing is in the closed position.

Visible fluid pathways when open

The housing is further configured to allow the fluid pathways to be viewed when the housing is in the open position.

Membrane with preservative for cellular separation

A membrane, disposed within the housing, wherein the membrane comprises a preservative; a portion of the membrane is configured to separate cellular material from the biological sample when the biological sample is introduced onto the membrane.

Structural member holding the membrane

A structural member disposed within the housing and configured to hold the membrane within the housing.

Mechanical actuator dispensing during open-to-closed movement

A mechanical actuator, configured to dispense the biological sample from the one or more fluid pathways onto the membrane when the housing is moved from the open position to the closed position.

Desiccant in the apparatus

A desiccant.

Capillary tube fluid pathways

The one or more fluid pathways comprise a capillary tube.

Reagent associated with the capillary tube or membrane

The apparatus further comprises a reagent (i) coated on an inner surface of the capillary tube or (ii) comprised in the membrane.

Plungers inserted into fluid pathways

The mechanical actuator comprises one or more plungers which are configured to be inserted into the one or more fluid pathways.

Overall, the claim coverage centers on an openable/closeable housing that directs a biological sample through one or more capillary-tube fluid pathways to a membrane containing a preservative with a cellular-separating function, while a mechanical actuator dispenses the sample onto the membrane during closing and the system includes a desiccant and a reagent associated with the capillary tube or membrane.

Stated Advantages

Improved quantitative assay opportunity versus standard dried blood spots.

Documented Applications

Infectious disease testing using the red cell portion and related separation/plasma collection on a separation/storage membrane or assay strip, as described conceptually in the document summary.

Quantitative assay processing based on separation of cellular material and/or providing a membrane suitable for assay regions, as described in the document summary.

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