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Publication Number
US-10906042-B2
Publication Date
2021-02-02
Expiration Date
Abstract
A new method is disclosed for extracting plasma from whole blood and metering the amount of plasma to an exact volume for dispensing into a diagnostic test, in a fully automatic and self-contained device. The device can be used in resource limited settings by unskilled users to facilitate sophisticated medical diagnostic testing outside of a hospital, clinic or laboratory.
Core Innovation
The invention provides a method of producing a filtrate available for collection by overcoming the breakthrough pressure of a filtration membrane. A soluble matrix is placed in physical contact with the downstream surface of the membrane so that it draws the filtrate through the membrane passively under capillary action, and the soluble matrix then completely or partially dissolves in the filtrate, releasing the filtrate from being bound within the matrix and making the filtrate available for collection.
The invention uses passive capillary forces to drive automatic filling and completion of filtration so that a filtrate collection structure of known volume receives the filtrate. Metering is achieved by defining known start points and known end points within capillary tube or capillary barrier structures, such that the metered volume equals the known volume enclosed by the geometry.
A filtration delivery and dispensing arrangement is described in which a device includes an outlet tip in fluid communication with a filtrate collection structure and a pneumatic pressure generating structure to dispense the metered volume to a desired point. In another aspect, the invention overcomes the breakthrough pressure and an inlet capillary barrier simultaneously by placing the soluble matrix in a space between the membrane downstream surface and an inlet of the filtrate collection structure.
The invention also includes loading a chemical or reagent into a filtrate collection structure by placing the chemical or reagent in a fluid flow path between the soluble matrix and the filtrate collection structure, so that the chemical or reagent is drawn into the collection structure as filtrate fills the collection structure. Additionally, a process is described for loading a precise volume of input liquid using a two-stage liquid delivery structure separated by a capillary barrier, where passive capillary forces fill the first delivery structure up to the capillary barrier and gravitational forces then move the liquid through a downstream liquid processing system upon rotating upright.
Claims Coverage
The provided independent claims describe five inventive features. Across the claims, the inventive features repeatedly rely on passive capillary forces and defined geometries or structures to achieve known volumes and controlled availability of filtrate for collection or dispensing.
Soluble matrix to overcome membrane breakthrough pressure for passive capillary filtrate release
A soluble matrix placed in physical contact with the downstream surface of a filtration membrane draws filtrate through the membrane passively under capillary action, and the soluble matrix then completely or partially dissolves in the filtrate to release the filtrate for collection.
Passive capillary driven metered collection with known-volume filtrate delivery and pneumatic dispensing
A filtration device having an inlet structure, a filtration membrane downstream of the inlet structure, a filtrate collection structure of known volume, and a filtrate dispensing structure comprised of an outlet tip and a pneumatic pressure generating structure, where the inlet fills automatically driven by passive capillary forces, filtration proceeds to completion driven by passive capillary forces, and collection proceeds to completion driven by passive capillary forces.
Simultaneous breakthrough pressure and inlet capillary barrier overcoming by positioning soluble matrix in an interstitial space
A soluble matrix is placed in a space between a downstream surface of a filtration membrane and an inlet of a filtrate collection structure such that a portion of the soluble matrix extends into the inlet and a portion is in physical contact between the downstream membrane surface and a base structure designed for holding the soluble matrix, filtrate collection structure and membrane in place.
Chemical or reagent loading during filtrate filling via flow path between soluble matrix and collection structure
A chemical or reagent is placed in a fluid flow path between a soluble matrix and a filtrate collection structure so that the chemical or reagent is drawn into the filtrate collection structure as the filtrate fills the collection structure.
Precise volume loading using two-stage liquid delivery structures with capillary barrier and gravity after rotation
A process loads a precise volume using a liquid collection structure comprising a first liquid delivery structure of specific dimensions and a second liquid delivery structure leading to a downstream liquid processing system, where the first delivery structure is filled up to a capillary barrier and then rotating upright allows gravitational forces to move the liquid through the downstream liquid processing system.
The claim set emphasizes overcoming filtration breakthrough pressure using a soluble matrix with passive capillary action, and maintaining known-volume metering through specified capillary structures or delivery geometries. It also includes simultaneous management of membrane breakthrough and inlet capillary barriers via matrix placement, reagent loading driven by filtrate filling, and precise-volume loading using a two-stage delivery arrangement separated by a capillary barrier with a gravity-based transfer step.
Stated Advantages
Overcomes the breakthrough pressure of a filtration membrane by use of a soluble matrix placed in physical contact with the downstream surface of the membrane.
Releases filtrate from being bound within the soluble matrix by complete or partial dissolution in the filtrate, making filtrate available for collection.
Allows filtrate to be drawn passively through the filtration membrane under capillary action.
Enables automatic filling driven by passive capillary forces to completion for inlet filling, filtration, and collection processes.
Allows metering of a collected filtrate volume using known start and end points defined by capillary tube or capillary barrier geometry, providing a known volume to be dispensed.
Simultaneously overcomes a filtration membrane breakthrough pressure and an inlet capillary barrier by placing the soluble matrix in a space between the downstream membrane surface and the collection inlet.
Draws a chemical or reagent into a filtrate collection structure as filtrate fills the collection structure.
Documented Applications
Producing filtrate collection and delivery for plasma or serum.
Loading a chemical or reagent into a filtrate collection structure for subsequent use within the device context.
Delivering a metered volume of filtrate to a specific location or point using an outlet tip and pneumatic pressure generating structure as part of a filtration/dispensing workflow.
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