Devices, systems, and methods for sample collection

Inventors

Beyerlein, Dagmar • Drexel, Masao • JORDAN, Brett L. • Jackson, Alicia • Juneau, Kara

Assignees

Drawbridge Health Inc

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Publication Number

US-10638963-B2

Patent

Publication Date

2020-05-05

Expiration Date


Abstract

Disclosed herein are devices, apparatus, systems, methods and kits for collecting and storing a fluid sample from a subject. A device for collecting the fluid sample can include a housing comprising a recess having an opening, a vacuum chamber in the housing and in fluidic communication with the recess, and one or more piercing elements that are extendable through the opening to penetrate skin of the subject. The vacuum chamber can be configured for having a vacuum that draws the skin into the recess. The recess can be configured having a size or shape that enables an increased volume of the fluid sample to be accumulated in the skin drawn into the recess.

Core Innovation

The invention relates to portable handheld blood collection devices, systems, and kits that collect and store blood from a subject. A housing includes a recess having an opening and a vacuum chamber in the housing having an initial state of a vacuum, and activation of the vacuum establishes fluidic communication between the vacuum chamber and the recess to draw skin of the subject into the recess. The recess serves as a suction cavity for drawing the skin.

One or more piercing elements are extendable through the opening to penetrate the skin to enable collection of blood while the skin is drawn into the recess. The recess is configured so that the volume of skin enclosed by the recess under vacuum and the surface area of the skin in contact with the recess are in specified ranges, and the recess has a size or shape configured to enable an increased volume of blood to be collected under increased capillary pressure differential.

Blood is collected into a cartridge chamber configured to receive a cartridge, and the cartridge is releasably coupled via a cartridge port to an output port in the cartridge chamber. The cartridge includes one or more matrices for collecting and storing blood, with two paper matrices disposed substantially parallel to each other and separated by one or more spacers to form a channel through which blood can flow via capillary action and wicking.

One or more absorbent pads are in fluidic communication with the one or more matrices and are configured to hold excess blood. The cartridge further includes a seal that seals the cartridge when in the cartridge chamber, and a window configured to enable a subject or user to monitor progress of blood collection as blood flows into and is collected in the cartridge.

Claims Coverage

The document includes two independent claims. Both focus on a vacuum suction cavity that draws skin into a recess, one or more piercing elements that penetrate the skin, and a cartridge chamber for collecting and storing blood. One independent claim further specifies parallel paper matrices, spacers forming a capillary and wicking channel, absorbent pads, a seal, and a monitoring window.

Vacuum suction cavity that draws skin into a recess for blood collection

A housing comprising a recess having an opening, and a vacuum chamber in the housing with an initial state of a vacuum. Activation of the vacuum establishes fluidic communication between the vacuum chamber and the recess to draw skin into the recess, wherein the recess serves as a suction cavity and the enclosed skin volume and surface area are in specified ranges.

Piercing elements extendable through the recess opening while skin is drawn under vacuum

One or more piercing elements extendable through the opening to penetrate the skin to enable collection of blood while the skin is drawn into the recess.

Releasably coupled cartridge port and output port for collecting into a cartridge

A cartridge chamber configured to receive a cartridge configured to hold one or more matrices for collecting and storing the blood, with the cartridge releasably coupled via a cartridge port to an output port in the cartridge chamber.

Cartridge structure with parallel paper matrices, spacers forming a capillary channel, and absorbent pads

A cartridge comprising two paper matrices disposed substantially parallel to each other and separated by one or more spacers to form a channel through which blood can flow via capillary action and wicking, and one or more absorbent pads configured to hold excess blood.

Seal and monitoring window

A seal that seals the cartridge when the cartridge is in the cartridge chamber, and a window configured to enable a subject or user to monitor progress of blood collection as the blood flows into and is collected in the cartridge.

The claim coverage centers on drawing subject skin into a suction recess using a vacuum chamber, penetrating the skin with piercing elements while under vacuum, and collecting blood into a cartridge chamber via a releasable cartridge port/output port arrangement. One claim further specifies a cartridge with paper matrices, spacers forming capillary-action and wicking channels, absorbent pads for excess blood, and a monitoring window.

Stated Advantages

Enables increased volume of blood to be collected under increased capillary pressure differential, with increased blood volume dependent on the volume and/or surface area of the skin drawn into the recess.

A window configured to enable a subject or user to monitor progress of blood collection as blood flows into and is collected in the cartridge.

Documented Applications

Collecting and storing blood from a subject using a vacuum chamber and a cartridge for matrices that collect and store blood.

Blood collection and storage from a subject, including monitoring blood collection progress.

On-spot analysis and shipping to a testing facility.

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