The present system is directed in various embodiments to devices, systems and methods for detection, evaluation and/or monitoring olfactory dysfunction by measuring and determining the patient's olfactory detection threshold for the left and the right nostril. More specifically, the present inventio
The present system is directed in various embodiments to devices, systems and methods for detection, evaluation and/or monitoring olfactory dysfunction by measuring and determining the patient's olfactory detection threshold for the left and the right nostril. More specifically, the present invention relates to devices, systems and methods for detecting an asymmetric differential in a patient's olfactory detection threshold (left vs right nostril) which, when present, may be used as a tool to screen, detect, diagnose and/or monitor relative olfactory deterioration resulting from Alzheimer's disease. A preferred embodiment comprises cascading aromas by serially administering more than one pure odorant to the patient's nostrils, left vs right, with measurement of the time, or numbers of breaths, required to cognitively notice the pure odorants' presence.
대표청구항▼
1. A method for ruling out the presence of Alzheimer's disease in a patient by measuring the sensitivity of the left and right olfactory bulbs to substances that only stimulate the first cranial nerve and not the 5th cranial nerve, comprising: providing at least two pure odorants, the pure odorants
1. A method for ruling out the presence of Alzheimer's disease in a patient by measuring the sensitivity of the left and right olfactory bulbs to substances that only stimulate the first cranial nerve and not the 5th cranial nerve, comprising: providing at least two pure odorants, the pure odorants capable of stimulating the first cranial nerve and not the 5th cranial nerve;establishing an introduction order for the at least two pure odorants; introducing pure odorant-infused air in the established introduction order to the patient's first nostril;measuring and recording a pure odorant detection metric for each of the pure odorant-infused air introductions, the pure odorant detection metric comprising the time and/or the number of inhalations required by the patient to reach a pure odorant detection threshold with the first nostril for each of the at least two pure odorants and switching from a first pure odorant in the established introduction order to the next pure odorant in the established introduction order after the patient reaches the pure odorant detection threshold for the first pure odorant;introducing pure odorant-infused air in the established introduction order to the patient's second nostril;measuring and recording a pure odorant detection metric for each of the pure odorant-infused air introductions, the pure odorant detection metric comprising the time and/or the number of inhalations required by the patient to reach a pure odorant detection threshold with the second nostril for each of the at least two pure odorants and switching from a first pure odorant in the established introduction order to the next pure odorant in the established introduction order after the patient reaches the pure odorant detection threshold for the first pure odorant;comparing the recorded pure odorant detection metric for the first nostril and the second nostril to obtain a relative pure odorant detection threshold value for each nostril;determining whether the obtained relative pure odorant detection threshold value for the first nostril is statistically different from the obtained relative pure odorant detection threshold for the second nostril; andconcluding that, if the patient's pure odorant detection threshold value for the patient's left nostril is not statistically higher than pure odorant detection threshold value for the patient's right nostril, the patient is ruled out for the presence of Alzheimer's disease, since the left and right olfactory bulbs have sensitivities to pure odorants that are statistically equivalent and therefore not consistent with Alzheimer's disease. 2. The method of claim 1, providing a device to introduce the more than two pure odorants in pure odorant infused-air to each of the patient's nostrils. 3. The method of claim 1, further comprising concluding that, if the patient's pure odorant detection threshold value for the patient's left nostril is not statistically greater than the pure odorant detection for the patient's right nostril, the patient's olfactory organ is not statistically impacted by Alzheimer's disease. 4. The method of claim 1, wherein the pure odorant detection threshold is the point at which the concentration of pure odorant molecules for each one of the cure odorants presented saturate the olfactory nerve to the extent that a cognitive reaction occurs. 5. The method of claim 2, the device comprising: a hand-held housing defining a chamber therein in valved communication with external atmospheric air;a nasal tip with a lumen therethrough, the lumen in fluid communication with the housing chamber;a pure odorant cartridge comprising a circular rigid body and having two sides, further comprising more than two pure odorant chambers defined by the rigid body, the more than two pure odorant chambers arranged sequentially in the established introduction order, and the cartridge being rotatably disposed in the housing; anda pure odorant disposed within each of the more than two sequentially arranged pure odorant chambers, wherein the sequentially arranged pure odorant chambers are successively rotatably aligned to enable a selected pure odorant chamber to move into fluid communication with the housing chamber and the nasal tip lumen. 6. The method of claim 5, the pure odorant cartridge comprising: a circular rigid central body and having two sides; andmore than two pure odorant chambers defined by the rigid body, each chamber arranged to hold an effective amount of one pure odorant, the more than two pure odorant chambers arranged sequentially in the established introduction order. 7. The method of claim 6, wherein the pure odorant cartridge further comprises a slot alignable with the position of each of the two or more pure odorant chambers in succession, the slot allowing atmospheric air to pass past or through the aligned pure odorant chamber to create the pure odorant-infused air or presentation to the nasal tip. 8. The method of claim 7, further comprising: advancing the pure odorant cartridge from the presenting of pure odorant infused air of a first pure odorant disposed in a first pure odorant chamber of the pure odorant cartridge to the patient's first nostril upon the patient's cognitive notice of the first pure odorant, indicating the patient has reached the pure odorant detection threshold for the first nostril and the first pure odorant; andpresenting of a second pure odorant infused air of a second pure odorant disposed in a second pure odorant chamber adjacent the first pure odorant chamber of the pure odorant cartridge to the patients first nostril until the patient's cognitive notice of the second pure odorant indicating the patient has reached the pure odorant detection threshold for the first nostril and the second pure odorant. 9. The method of claim 1, further comprising: switching from presenting a first pure odorant air flow to one of the patient's first nostrils upon cognitive notice of the first pure odorant by the patient indicating reaching of the pure detection threshold for the first pure odorant with the first nostril;presenting a second pure odorant air flow to the first nostril, whereupon the patient's cognitive notice of the first pure odorant is replaced by cognitive notice of the second pure odorant when the pure odorant detection threshold is reached for the second pure odorant, without aid of a reset period interposed between the presenting of the first pure odorant air flow and the presenting of the second pure odorant air flow. 10. The method of claim 5, the device further comprising oleophobic airways. 11. The method of claim 1, wherein the pure odorant detection metric further comprises the sum of periods measured in seconds elapsed between the presentation of the first pure odorant of the at least two pure odorants and the patient's reaching the pure odorant detection threshold for the first pure odorant, followed by immediate switching to the second pure odorant of the at least two pure odorants and presentation of the second pure odorant of the at least two pure odorants, and the patient's reaching the pure odorant detection threshold for the second pure odorant of the at least two pure odorants. 12. The method of claim 11, further comprising comparing the summed pure odorant metrics for the left nostril and the right nostril and determining whether the left nostril's summed pure odorant metric statistically differs from the summed pure odorant metric for the right nostril. 13. The method of claim 12, further comprising ruling out olfactory damage consistent with Alzheimer's disease if the summed pure odorant metrics for the left nostril are not statistically greater than the summed pure odorant metrics for the right nostril. 14. The method of claim 6, wherein the more than two pure odorants comprise a single pure odorant with successively increasing concentrations disposed in successive and adjacent pure odorant chambers until cognitive notice indicating the patient has reached the pure odorant detection threshold. 15. The method of claim 1, further comprising the at least two pure odorants consisting of the same pure odorant wherein the established introduction order comprises the pure odorant in successively increasing concentration until cognitive notice indicating the patient has reached the pure odorant detection threshold. 16. The method of claim 2, the device further comprising a bilateral visual indication that sufficient airflow is present to ensure valid results.
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이 특허에 인용된 특허 (10)
Walker James C. (Winston-Salem NC) Kurtz Daniel B. (Winston-Salem NC) Shore Ford M. (Winston-Salem NC), Apparatus for assessing responses of humans to stimulants.
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