Mask-Based Diagnostic System using Exhaled Breath Condensate
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.
1 . A method of manufacturing a thermal-mass subassembly for an exhaled-breath-condensate (EBC) collector, comprising:
providing a substrate at a forming region;
forming a pocket in the substrate to define a cavity;
dispensing a thermal-mass composition into the cavity; and
sealing the substrate to seal the thermal mass composition in the cavity, where the thermal mass is in thermal communication with a condensation surface of the EBC collector.
2 . The method of claim 1 , wherein the substrate comprises a laminate and adhesive layers provided as web-based materials with the forming region being located at a step in a roll-to-roll manufacturing process.
3 . The method of claim 1 , wherein at least one of the forming and sealing steps is done under vacuum.
4 . The method of claim 1 , wherein the barrier layer comprises a heat-conductive metal layer.
5 . The method of claim 1 , wherein forming the pocket comprises thermoforming the pocket comprises by pressing the laminate against a forming surface to define a pocket geometry and a surrounding heat-seal land.
6 . The method of claim 1 , wherein the thermal mass composition comprises an endothermic chemical.
7 . A thermal-mass subassembly configured for integration with an EBC collection mask, comprising:
a web-based laminate including a barrier layer and an adhesive layer;
a pocket formed in the laminate defining a sealed cavity;
a thermal-mass composition encapsulated within the sealed cavity;
a hermetic perimeter seal surrounding the sealed cavity; and
a condensation surface in thermal contact with the thermal-mass composition.
8 . The thermal-mass subassembly of claim 7 , wherein the barrier layer comprises a heat-conductive metal foil.
9 . The thermal-mass subassembly of claim 7 , wherein the adhesive layer comprises at least one of a pressure-sensitive adhesive and a thermally activated adhesive.
10 . The thermal-mass subassembly of claim 7 , wherein the thermal-mass composition comprises water and a super-absorbent polymer (SAP) forming a hydrogel retained within the sealed cavity.
11 . The thermal-mass subassembly of claim 7 , wherein the thermal-mass composition comprises an endothermic assembly including water and an endothermic chemical, the subassembly further comprising a frangible internal barrier separating the water and the salt prior to activation, such that rupture of the frangible barrier initiates an endothermic reaction within the sealed cavity.
12 . A diagnostic mask system for collecting exhaled breath condensate, comprising:
a mask body forming a breath containment volume; and
the thermal-mass subassembly fixed inside the breath containment volume, the thermal-mass subassembly including a condensation surface,
wherein the thermal-mass subassembly provides thermal capacity during use to regulate a temperature of the condensation surface and promote condensation of exhaled breath.
13 . The diagnostic mask system of claim 12 , wherein the thermal-mass composition of the subassembly comprises an endothermic assembly including water and a salt selected from ammonium nitrate, calcium ammonium nitrate, or urea, and the subassembly further comprises a frangible internal barrier configured to be ruptured to initiate an endothermic reaction within the sealed cavity.