Apparatus, Method, and System for Testing Human Olfactory Systems

• US 20160287161A1
• Filed: 03/31/2016
• Published: 10/06/2016
• Est. Priority Date: 04/03/2015
• Status: Active Grant

• Current Assignee: Olfaxis, LLC
• Original Assignee: Olfaxis, LLC
• Inventors: Smith, David W., Eberdt, Jesse S. III
• Granted Patent: US 10,682,087 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 5/4011 Evaluating olfaction, i.e. sense of smell
• CPC Class Codes: A61B 5/4088 Diagnosing of monitoring cognitive diseases, e.g. Alzheimer, prion diseases or dementia

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.

Claims

1-20. -20. (canceled)

21. A method for standardized testing of olfactory system function, comprising:

providing a device constructed and configured with at least one cartridge having at least one odorant for delivering a predetermined amount and a predetermined concentration via a controlled odorant delivery mechanism, and

activating the device to deliver to a test subject the predetermined concentration of the at least one odorant for providing a standardized test for olfactory function.

22. The method of claim 21, further including the step of delivering a series of standardized doses of the at least one odorant.

23. The method of claim 21, further including the step of delivering a series of standardized doses of a multiplicity of predetermined odorants.

24. The method of claim 23, wherein the method is suitable for testing at least an odor sensitivity and an odor identification, and/or an odor discrimination, an odor adaptation, and an odor masking of the test subject.

25. The method of claim 21, further including the step of recording test results.

26. The method of claim 21, further including the step of reporting test results for the test subject.

27. The method of claim 21, further including the step of reporting the test results for the test subject compared to a population.

31. A system for standardized testing of olfactory system function, comprising:

a compressed gas source, a carrier mass gas controller, a stimulus mass gas controller, at least one standardized stimulus odorant cartridge including at least one odorant, at least one stimulus odorant cartridge activator, and an output;

wherein the compressed gas source produces compressed gas to be channeled through the standardized stimulus odorant cartridge to the output; and

wherein the carrier mass gas controller and stimulus mass gas controller control the carrier gas mass flow and the stimulus gas mass flow, respectively, to provide a predetermined concentration of the at least one odorant to a test subject,

thereby providing a standardized test for olfactory function.

32. The system of claim 31, wherein the system delivers a series of standardized doses of the at least one odorant.

33. The system of claim 31, wherein the system delivers a series of standardized doses of a multiplicity of predetermined odorants.

34. The system of claim 33, wherein the system tests at least odor sensitivity and odor identification, and/or odor discrimination, odor adaptation, and odor masking.

35. The system of claim 31, wherein the at least one standardized stimulus odorant cartridge is a puncture-activated, non-resealable cartridge that is standardized to provide a predetermined number of tests at a predetermined concentration and configured to fit into the at least one olfactory measurement apparatus.

36. The system of claim 31, wherein the at least one computing device communicates over a network with the at least one olfactory measurement apparatus;

and further including;

a remote database accessible by the computing device over the network;

wherein the at least one computing device receives test results from the at least one olfactory measurement apparatus and stores them in the remote database, and wherein the at least one computing device compares the test results from the at least one olfactory measurement apparatus with test results stored in the remote database;

thereby providing a standardized test for olfactory function.

37. The system of claim 36, further comprising a multiplicity of olfactory measurement apparatuses in real-time communication with the at least one computing device and database.

38. The system of claim 31, wherein the cartridge includes an identifier with information and the device includes an identifier reader, and wherein the device uses the identifier information to control the testing or access information to control the testing.

39. The method of claim 38, wherein the information used to control the testing is selected from the group consisting:

the name of the odorant, carrier, concentration in carrier, headspace of the cartridge, maximum flow rate through the cartridge, total actuatable volume, maximum total odorant available, the vapor pressure, vapor ionization voltage, time required to saturate the headspace, and combinations thereof.