Apparatus, method, and system for testing human olfactory systems

Abstract

An apparatus, module, methods and systems for automated, standardized assessment and analysis of a human olfactory system's odor detection ability as an indicator or predictor of cognitive impairment or change in cognitive health, and other health conditions such as diabetes. Notably, the present invention is operable for use across all age groups of humans and provides quantitative detection and analysis of a human olfactory system's detection ability compared to a relevant demographic population.

1 . A method for testing olfactory system function, comprising
 providing a cartridge-based olfactometry system;   providing a puncture-activated, non-resealable cartridge with an odorant and a headspace, the cartridge standardized to provide a predetermined number of tests at a predetermined concentration into the olfactometry system;   inserting the cartridge in the olfactometry system and activating it; and   testing an organism.   
     
     
         2 . The method of  claim 1 , wherein the olfactometry system further includes an extra headspace cartridge and the method steps include recirculating the headspace gas between the odorant cartridge and the extra headspace cartridge. 
     
     
         3 . The method of  claim 1 , further including the step of the olfactometry system detecting the concentration of the odorant in the headspace of the odorant cartridge. 
     
     
         4 . The method of  claim 1 , wherein the olfactometry system further includes a cartridge identifier reader and the odorant cartridge includes an identifier; the method steps include the olfactometry system reading the identifier and adjusting the gas flow through the cartridge based on the information from the identifier. 
     
     
         5 . The method of  claim 1 , wherein the olfactometry system further includes:
 a computing device operable to communicate over a network; and   a remote database accessible by the computing device over the network; and
 wherein the computing device receives test results, stores them in the remote database, and compares them with test results stored in the remote database. 
   
     
     
         6 . The method of  claim 5 , wherein the olfactometry system includes multiple, geographically distributed testers in real-time communication with the database and the method steps include the database updating in real-time with test results from the distributed testers. 
     
     
         7 . A method for testing olfactory system function, comprising:
 determining a present minimum concentration of an odorant in a carrier gas needed in an odorant containment structure to obtain a present positive response to the odorant;   creating an olfaxis composite index based on the present minimum concentration of the odorant in the carrier gas needed in the odorant containment structure to obtain the present positive response to the odorant, wherein the olfaxis composite index is created by:
 dividing a past minimum concentration of the odorant in the carrier gas needed in the odorant containment structure to obtain a past positive response by the present minimum concentration of the odorant in the carrier gas needed in the odorant containment structure to obtain the positive response to the odorant, or 
 dividing an average past minimum concentration of the odorant in the carrier gas needed in the odorant containment structure to obtain past positive responses by the present minimum concentration of the odorant in the carrier gas needed in the odorant containment structure to obtain the positive response to the odorant. 
   
     
     
         8 . The method of  claim 7 , wherein determining the present minimum concentration of the odorant in the carrier gas needed in the odorant containment structure to obtain the present positive response to the odorant includes:
 providing a predetermined concentration of the odorant in the carrier gas using a carrier gas assembly and an olfactory measurement apparatus;   delivering the predetermined concentration of the odorant in the carrier gas from the olfactory measurement apparatus to the odorant containment structure;   determining the present positive response to the odorant or a present negative response to the odorant at the predetermined concentration of the odorant;
 if the present negative response to the odorant is determined, providing at least one sequential predetermined concentration of the odorant in the carrier gas using the carrier gas assembly and the olfactory measurement apparatus until the present positive response is determined, wherein the at least one sequential predetermined concentration of the odorant in the carrier gas is an increased concentration of the odorant in the carrier gas compared to the predetermined concentration of the odorant in the carrier gas; and 
 upon determining the present positive response, determining the predetermined concentration of the odorant in the carrier gas or the at least one sequential predetermined concentration of the odorant in the carrier gas to be the present minimum concentration of the odorant in the carrier gas. 
   
     
     
         9 . The method of  claim 7 , wherein the present positive response to the odorant is given by a user and wherein the past positive response is given by the user. 
     
     
         10 . The method of  claim 7 , wherein the present positive response to the odorant is given by a user, and wherein the past positive responses are given by a demographic population having similar age, weight, gender, socioeconomic status, ethnicity, height, genetic predispositions, existing health conditions, and/or combinations thereof to the user. 
     
     
         11 . An apparatus for producing a predetermined concentration of an odorant comprising:
 a main inlet;   a main outlet;   a piston assembly including a piston, a piston shaft, and a carrier chamber;   a linear potentiometer;   a mixing chamber;   a scent reservoir;   a carrier gas inlet valve controlled by a carrier gas inlet solenoid;   a mixture outlet valve controlled by a mixture outlet solenoid;   an odor inlet valve controlled by an odor inlet solenoid; and   a mixing chamber valve controlled by a mixing chamber solenoid,   wherein upon opening of the carrier gas inlet valve, carrier gas flows into the apparatus from a carrier gas assembly;   wherein upon opening of the odor inlet valve, the carrier gas flows into the scent reservoir to mix with an odorant in the scent reservoir to create a concentration of odorant in the carrier gas;   wherein upon retraction of the piston, the piston assembly is operable to receive the concentration of odorant in the carrier gas up to the point of retraction of the piston;   wherein upon opening of the mixture outlet valve, opening of the mixing chamber valve, and reverse retraction of the piston, the piston assembly is operable to force the concentration of odorant in the carrier gas through the mixing chamber and out of the main outlet of the apparatus.   
     
     
         12 . The apparatus of  claim 11 , further comprising a linear potentiometer for controlling movement of the piston. 
     
     
         13 . The apparatus of  claim 11 , further comprising an ultrasonic transducer for activating the odorant in the scent reservoir. 
     
     
         14 . The apparatus of  claim 11 , further comprising a photoionozation detector (PID) for measuring the concentration of odorant in the carrier gas. 
     
     
         15 . The apparatus of  claim 11 , wherein the carrier gas inlet valve, the mixture outlet valve, the odor inlet valve, and the mixing chamber valve each include an o-ring for creating an air-tight seal when closed. 
     
     
         16 . A system for assessing, analyzing, and quantifying olfactory system function comprising:
 at least one olfactory measurement apparatus comprising:
 a system controller, a carrier gas assembly comprising a first piston assembly, an odorant gas assembly comprising a second piston assembly, at least one odorant detector, a mixer coupled to the first piston assembly and the second piston assembly, a reader and an output configured to couple to a nasal delivery device, 
 wherein the reader is configured to electronically obtain information from an odorant source device, wherein the system controller is in communication with the reader and is configured to electronically direct the at least one olfactory measurement apparatus to run a test sequence using different defined concentrations of one or more odorant from the odorant source device for delivery to the output based, at least in part, on to the obtained information, and wherein the at least one odorant detector measures a concentration of odorant in a respective at least one olfactory measurement apparatus; and 
 a remote database configured to obtain test data from the at least one olfactory measurement apparatus over a computer network. 
   
     
     
         17 . The system of  claim 16 , wherein the system controller directs a linear actuator coupled to the second piston assembly to move at a controlled speed and/or move a defined distance to provide a defined volume of an odorant gas of a respective odorant in the second piston assembly, then directs the second piston assembly to discharge the defined volume to the mixer. 
     
     
         18 . The system of  claim 17 , wherein the system controller directs a linear actuator coupled to the first piston assembly to move at a controlled speed to provide a carrier gas to the mixer, and wherein, during one or more test sequences, the system controller directs the first and second linear actuators to move to provide adjustable and controlled concentrations of a respective odorant in an odorant and carrier gas mixture that is fluidly directed to the output. 
     
     
         19 . The system of  claim 16 , further comprising a first linear actuator coupled to the first piston assembly and a second linear actuator coupled to the second piston assembly, wherein the system controller controls distance and/or velocity of movement of the first and second linear actuators to provide controlled adjustable concentrations of odorant in odorant gas and carrier gas mixtures for the test sequence. 
     
     
         20 . The system of  claim 16 , wherein the system is configured to generate an olfaxis composite index derived from different olfactory measures based on the test data.