Device and method for collection of exhaled alveolar breath condensate

Abstract

A diagnosis method for respiratory disease based on the separation of the expired airway phase in an exhaled breath from the alveolar phase, and a device to accomplish the method. The device includes a cartridge assembly and a disposable condensing chamber carried in a substantially enclosed housing. The cartridge assembly includes a disposable cartridge and a reusable control system that monitors a characteristic of gas passing through the cartridge to determine when to divert the exhaled breath to an exhaust outlet and when to divert the exhaled breath to the condensing chamber. The characteristic is selected as being representative of the transition from the expired airway phase to the alveolar phase. Also included are a refrigeration system, an auxiliary monitoring system for determining when a sufficient volume of gas has been produced, and a built-in analyzer.

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       42 . An apparatus for separating the expired airway phase of breath exhaled by a mammalian subject from the alveolar phase of the exhaled breath, the apparatus comprising: 
 (a) a fluid inlet;    (b) at least a first fluid outlet and a second fluid outlet;    (c) a valve assembly adjustable between at least two states, the at least two states including a first state wherein fluid received at the fluid inlet is diverted to the first fluid outlet, and a second state wherein fluid received at the fluid inlet is diverted to the second fluid outlet; and    (d) a control system that adjusts the state of the valve assembly, the control system including: 
 a spectrometer arranged to monitor at least one characteristic of a generally gaseous fluid passing through the separation apparatus, the characteristic generally capable of distinguishing the expired airway phase of an exhaled breath from a mammalian subject from the alveolar phase of the exhaled breath, and  
 an actuator device, coupled to the spectrometer and the valve assembly, that adjusts the state of the valve assembly on the basis of the state of the monitored characteristic.  
   
   
   
       43 . The apparatus of  claim 42 , wherein the spectrometer is arranged to measure the partial pressure of a particular predetermined gas in the gaseous fluid passing through the separation apparatus.  
   
   
       44 . The apparatus of  claim 43 , wherein the actuator device adjusts the state of the valve assembly from its first state to its second state when the partial pressure of the particular predetermined gas reaches a predetermined level.  
   
   
       45 . The apparatus of  claim 44 , wherein the partial pressure reaches the predetermined level by rising to the predetermined level.  
   
   
       46 . The apparatus of  claim 44 , wherein the partial pressure reaches the predetermined level by dropping to the predetermined level.  
   
   
       47 . The apparatus of  claim 44 , wherein the particular predetermined gas is selected from the group consisting of CO 2 , O 2 , N 2 , CO and NO.  
   
   
       48 . The apparatus of  claim 44 , wherein the fluid inlet, the at least two fluid outlets and the valve assembly define a cartridge assembly, and wherein the apparatus further comprises a housing adapted to carry the cartridge assembly and the control system.  
   
   
       49 . The apparatus of  claim 48 , wherein the cartridge assembly is adapted to be removable from the housing for disposal after a single use, while the control system is adapted for repeated reuse.  
   
   
       50 . The apparatus of  claim 44 , further comprising a chamber having an inlet connected in fluid communication with one of the at least two fluid outlets and adapted to collect at least a portion of the generally gaseous fluid passing through the separation apparatus.  
   
   
       51 . The apparatus of  claim 50 , wherein the chamber is a condensing chamber adapted to collect liquid condensed out of the generally gaseous fluid.  
   
   
       52 . The apparatus of  claim 50 , wherein the chamber is connected to the second fluid outlet, and wherein the actuator device adjusts the valve assembly from the first state to the second state when the partial pressure reaches the predetermined level.  
   
   
       53 . The apparatus of  claim 50 , wherein the chamber is connected to the second fluid outlet, and wherein the actuator device adjusts the valve assembly from the second state to the first state when the partial pressure reaches the predetermined level.  
   
   
       54 . The apparatus of  claim 43 , wherein the valve assembly includes a valve adjustable between at least two positions, wherein in the first valve assembly state the valve is in a first position diverting fluid received at the fluid inlet to the first fluid outlet and away from the second fluid outlet, and wherein in the second valve assembly state the valve is in a second position diverting fluid received at the fluid inlet to the second fluid outlet and away from the first fluid outlet.  
   
   
       55 . The apparatus of  claim 54 , wherein the valve is a directional flap.  
   
   
       56 . The apparatus of  claim 55 , wherein the actuator device is a rotary solenoid.  
   
   
       57 . The apparatus of  claim 43 , wherein the valve assembly includes at least two valves.  
   
   
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