EP-4736691-A2 - MASK-BASED DIAGNOSTIC SYSTEM USING EXHALED BREATH CONDENSATE

EP4736691A2EP 4736691 A2EP4736691 A2EP 4736691A2EP-4736691-A2

Abstract

A mask-based diagnostic apparatus is provided for detecting a biomarker contained in exhaled breath of a test subject. An exhaled breath condensate (EBC) collector converts breath vapor received from the lungs and airways of the test subject into a fluid biosample. The EBC collector including a thermal mass, a condensate-forming surface and a fluid conductor disposed on the condensate-forming surface. A fluid transfer system receives the fluid biosample from the EBC collector. A biomarker testing unit receives the fluid biosample from the fluid transfer system and tests the fluid biosample for a target biomarker. A testing system support is provided for supporting the EBC collector, the fluid transfer system and the biomarker testing unit. The testing system support is configured and dimensioned to fit inside a face mask. A face mask is provided forming an exhaled breath vapor containment volume to hold the exhaled breath vapor in proximity to the EBC collector to enable the condensate-forming surface cooled by the thermal mass to coalesce the exhaled breath vapor into the fluid biosample.

Inventors

DANIELS, JOHN J.

Assignees

Daniels, John J.

Dates

Publication Date: 20260506
Application Date: 20210418

Claims (12)

A mask-based diagnostic apparatus for detecting a biomarker contained in exhaled breath of a test subject, comprising: an exhaled breath condensate (EBC) collector for converting breath vapor received from the lungs and airways of the test subject into a fluid biosample, the EBC collector including a thermal mass, a condensate-forming surface and a fluid conductor disposed on the condensate-forming surface; a fluid transfer system for receiving the fluid biosample from the EBC collector; a biomarker testing unit for receiving the fluid biosample from the fluid transfer system and testing the fluid biosample for a target biomarker contained in the fluid biosample; a testing system support for supporting the EBC collector, the fluid transfer system and the biomarker testing unit, wherein the testing system support is configured and dimensioned to fit inside a face mask; and a face mask forming an exhaled breath vapor containment volume to hold the exhaled breath vapor in proximity to the EBC collector to enable the condensate-forming surface cooled by the thermal mass to coalesce the exhaled breath vapor into the fluid biosample.
A mask-based diagnostic apparatus according to claim 1, wherein the fluid transfer system comprises a biosample pooling area for pooling the fluid biosample received from the EBC collector; wherein the biomarker testing unit comprises a lateral flow assay where the fluid biosample flows through a multi-zone transfer medium through capillary action, the lateral flow assay including a sample pad disposed at the pooling area for receiving the fluid biosample, a conjugate release pad at which is formed a biomarker-labeled capture molecule complex, a detection zone and a flow membrane for causing the fluid sample flow from the sample pad through the release pad to the detection zone to detect the potential biomarker.
A mask-based diagnostic apparatus according to claim 2, where the fluid transfer system further comprises a fluid dam disposed in fluid communication between the EBC collector and the pooling area for accumulating a quantity of the fluid biosample until the fluid dam releases the quantity of the fluid biosample to flood the pooling area with the accumulated quantity of the fluid biosample and provide the accumulated quantity of the fluid biosample to the sample pad, where the fluid dam comprises one of a dissolvable material that is removed by being dissolved by the fluid biosample and a non-permeable material that is removed by a pull tab, where the removal of the fluid dam releases the accumulated quantity of the fluid biosample to flood the pooling area.
A mask-based diagnostic apparatus according to claim 1, wherein the fluid transfer system comprises a biosample pooling area for pooling the fluid biosample received from the EBC collector; wherein the biomarker testing unit comprises a lateral flow assay where the fluid biosample flows through a multi-zone transfer medium through capillary action, the lateral flow assay including a conjugate release pad disposed at the pooling area for receiving the fluid biosample, the conjugate release pad having capture molecules for capturing target molecules of the target biomarker and forming biomarker-labeled capture molecule complexes, the lateral flow assay further comprising a detection zone and a flow membrane for causing the fluid sample to flow from the conjugate release pad to the detection zone to detect the target biomarker, the fluid transfer system further comprising a fluid dam disposed in fluid communication between the conjugate release pad and the detection zone, where at the conjugate release pad a quantity of the fluid biosample is pooled over a time in contact with the capture molecules to provide the time and an opportunity for the capture molecules to bind with target molecules until the fluid dam releases the quantity of the fluid biosample with the biomarker-labeled capture molecule complexes formed over the time to flow along with the accumulated biosample from the conjugate release pad to the detection zone, where the fluid dam comprises one of a dissolvable material that is removed by being dissolved by the fluid biosample and a non-permeable material that is removed by a pull tab, where the removal of the fluid dam releases the at least a portion of the accumulated quantity of the fluid biosample and the biomarker-labeled capture molecule complexes formed over the time to flow to the detection area.
A mask-based diagnostic apparatus according to claim 1, wherein the biomarker testing unit comprises an electronic biosensor having capture molecules for capturing the target molecules contained in the fluid biosample and outputting an electrical signal dependent on the target molecules captured by the capture molecules.
A mask-based diagnostic apparatus according to claim 5, where the fluid transfer system includes a wick for absorbing a flow of the fluid biosample after the biomarker testing unit tests the flow of the fluid biosample, whereby the fluid biosample is caused to flow over the electronic biosensor over time so that the target molecules flow along with the fluid biosample to enable an opportunity for the capture molecules to capture the target molecules flowing along with the fluid biosample over the electronic biosensor.
A mask-based diagnostic apparatus according to claim 6, where the wick includes at least one of a super-absorbant-polymer (SAP) and a flow transfer layer for receiving and absorbing the flow of the fluid biosample; and where the thermal mass includes at least one of a metal foil, a contoured shape having flow transfer channels, an endothermic chemical reaction, a metal slug, and a composite material thermally enhanced for absorbing heat energy from the exhaled breath vapor, water, a water and SAP gel, and a composite layered structured; where the condensate-forming surface is at least one of a front surface of the thermal mass, a printed substrate having hydrophobic and hydrophilic channels and a coating printed to form a boundary to define the fluid conductor; where the fluid conductor is at least one of a coating printed to form a boundary and define the condensate-forming surface, the surface of the contoured shape, defined areas of the front surface of thermal mass having a hydrophilic texture, a microfluidic assembly having a transfer volume for absorbing the fluid biosample; and where the at least one capture molecule includes at least one of an aptamer, an engineered antibody, an antibody, proteins, antigens, nucleic acid-based ligands, and small molecules engineered to mimic monoclonal antibodies.
A mask-based diagnostic apparatus according to claim 5, where the electronic biosensor comprises an electrode layer having at least a source and a drain electrode; a binding surface disposed between the source and drain electrodes and functionalized with at least one capture molecule to capture the target biomarker, where capturing the target biomarker changes at least one electrical characteristic between the source and drain electrodes, where each capture molecule has an infinity for a respective biomarker, and further comprising an electronic circuit for receiving the output signal from the biomarker testing unit, determining a test signal value dependent on the affinity and calculating a result value for said at least one capture molecule and said respective biomarker.
A mask-based diagnostic apparatus according to claim 8, where the electronic biosensor further comprises a substrate, and the binding surface is a top surface of a binding bulk and a bottom surface of the binding bulk is diffusion bonded to the substrate.
A mask-based diagnostic apparatus according to claim 5, where the fluid transfer system is configured and dimensioned to pool an accumulation of the fluid biosample over the electronic biosensor, the fluid biosample is pooled over a time in contact with the capture molecules of the electronic biosensor to provide the time and an opportunity for the capture molecules to bind with target molecules while the fluid biosample accumulates.
A mask-based diagnostic apparatus according to claim 10, where the fluid transfer system is configured and dimensioned to flow a predetermined volume of the fluid biosample over the electronic biosensor during a predetermined amount of time, and where a concentration of target molecules are determinable as a function of the predetermined volume of the fluid biosample flowing over the electronic biosensor in the predetermined amount of time and a change in the electrical signal, where the electronic biosensor outputs an electrical signal having a change in electrical characteristics dependent on a capture molecule that changes the electrical signal dependent on the captured biomarker.
A mask-based diagnostic apparatus according to claim 11, wherein the fluid conductor includes a transfer volume for absorbing the fluid biosample, where the transfer volume has a absorption saturation point, where the fluid conductor conducts the fluid biosample at a slow rate before the absorption saturation point is reached and at a fast rate after the absorption saturation point is reached, and further comprising a flow initiation fluid freezable in the fluid conductor to facilitate reaching the adsorption saturation point during use, where the freezable solution includes at least one of a buffer and calibration ingredient for the test unit, where the calibration ingredient allows the electronic circuit to determine a calibration value from the initiation fluid, where prior to use of the mask-based diagnostic apparatus the freezable solution is held in a frozen state and during use of the mass-based diagnostic apparatus the freezable solution thaws and wets surfaces of the EBC collector to facilitate fluid transfer of the EBC liquid biosample.

Description

RELATED APPLICATIONS: This international application claims the benefit of priority of US Utility Patent Application Titled Mask-Based Diagnostic System using Exhaled Breath Condensate, Serial No. 17189711, filed 02-March-2021, which is a continuation-in-part and relates to and claims priority of co-pending US Utility Patent Application Titled Mask-Based Testing System for Detecting Biomarkers in Exhaled Breath Condensate, Aerosols and Gases, Serial No.: 17065488, filed 07-October-2020; and co-pending US Utility Patent Application Titled Using Exhaled Breath Condensate, Aerosols and Gases for Detecting Biomarkers, Serial No.: 16882447, filed 23-May-2020, and co-pending US Utility Patent Application Titled: Using Exhaled Breath Condensate for Testing for a Biomarker of COVID-19, Serial No.: 16876054, filed 17-May-2020, and US Provisional Applications Titled: A Low Cost, Scalable, Accurate, and Easy-to-Use Testing System for COVID-19, Serial No.: 63012247 filed 19-APR-2020; Using Exhaled Breath Condensate for Testing for a Biomarker of COVID-19, Serial No.: 63019378 filed 03-MAY-2020; and Using Exhaled Breath Condensate for Testing for a Biomarker of COVID-19, Serial No.: 63026052 filed 17-May-2020; the disclosures of which are herein incorporated by reference in their entireties. TECHNICAL FIELD: The exemplary and non-limiting embodiments of this invention relate generally to diagnostic systems, methods, devices and computer programs and, more specifically, relate to digital diagnostic devices for detecting a biomarker of a biological agent such as a coronavirus. The present invention also pertains to a device architecture, specific-use applications, and computer algorithms used to detect biometric parameters for the treatment and monitoring of physiological conditions in humans and animals. BACKGROUND: This section is intended to provide a background or context to the exemplary embodiments of the invention as recited in the claims. The description herein may include concepts that could be pursued but are not necessarily ones that have been previously conceived, implemented or described. Therefore, unless otherwise indicated herein, what is described in this section is not prior art to the description and claims in this application and is not admitted to being prior art by inclusion in this section. Governments around the world have instituted stay at home policies and the lockdown of citizens to slow the spread of the COVID-19 virus. There are currently billions of people around the world that have halted their usual employment, entertainment and socializing activities. Testing for biomarkers that indicate exposure, infection and recovery from COVID-19 can be used to enable a safer and more efficient restart of economic activities, while minimizing the spread of the virus. For example, protein and RNA testing for active virus shows who is currently contagious. Antibody testing can be used to find the members of a population that have recovered from the virus and now may be immune to reinfection. This knowledge could enable precision social distancing and more effective contact tracing, with the re-employment of a growing workforce of protected individuals and consumers. Those who remain at-risk of infection and transmission can be kept sequestered until a vaccine or other solution such as a high success rate pharmaceutical therapy is developed. SUMMARY: The below summary section is intended to be merely exemplary and non-limiting. The foregoing and other problems are overcome, and other advantages are realized, by the use of the exemplary embodiments of this invention. In accordance with a non-limiting exemplary embodiment, a mask-based diagnostic apparatus is provided for detecting a biomarker contained in exhaled breath of a test subject. An exhaled breath condensate (EBC) collector converts breath vapor received from the lungs and airways of the test subject into a fluid biosample. The EBC collector including a thermal mass, a condensate-forming surface and a fluid conductor disposed on the condensate-forming surface. A fluid transfer system receives the fluid biosample from the EBC collector. A biomarker testing unit receives the fluid biosample from the fluid transfer system and tests the fluid biosample for a target biomarker. A testing system support is provided for supporting the EBC collector, the fluid transfer system and the biomarker testing unit. The testing system support is configured and dimensioned to fit inside a face mask. A face mask is provided forming an exhaled breath vapor containment volume to hold the exhaled breath vapor in proximity to the EBC collector to enable the condensate-forming surface cooled by the thermal mass to coalesce the exhaled breath vapor into the fluid biosample. In accordance with a non-limiting exemplary embodiment, a mask-based testing system for detecting a biomarker received from lungs and airways of a test subject includes an exhaled breath condensate (EB