Methods for cascading pure odorants to the nostrils of patients
원문보기
IPC분류정보
국가/구분
United States(US) Patent
등록
국제특허분류(IPC7판)
A61B-005/08
A61B-005/00
A61M-015/08
A61M-021/00
A61M-015/00
출원번호
US-0094327
(2016-04-08)
등록번호
US-9936913
(2018-04-10)
발명자
/ 주소
Mills, Gregory B.
출원인 / 주소
Inspired Technologies, Inc.
대리인 / 주소
Barnes & Thornburg, LLP
인용정보
피인용 횟수 :
0인용 특허 :
10
초록▼
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 cascading at least two pure odorants to the nostrils of a patient, comprising: providing at least two pure odorants capable of stimulating the first cranial nerve of the patient but not the fifth cranial nerve;establishing an introduction order for the at least two pure odorants;intr
1. A method for cascading at least two pure odorants to the nostrils of a patient, comprising: providing at least two pure odorants capable of stimulating the first cranial nerve of the patient but not the fifth cranial nerve;establishing an introduction order for the at least two pure odorants;introducing the at least two pure odorants in pure odorant-infused air in the established introduction order to the patient's first nostril, wherein the first nostril is the patient's right or left nostril, wherein when the patient indicates reaching the pure odorant detection threshold for an introduced pure odorant, the next successive pure odorant in the introduction order is introduced to the first nostril;measuring and recording a metric for an olfactory threshold latency period, the metric measuring the number of breaths taken by the patient between the introduction of the pure-odorant infused air to the reaching of the pure odorant detection threshold for each introduction of the pure odorant-infused air to the first nostril;introducing the at least two pure odorants in pure odorant-infused air in the established introduction order to the patient's second nostril, wherein when the patient indicates reaching the pure odorant detection threshold for an introduced pure odorant, the next successive pure odorant in the introduction order is introduced to the second nostril;measuring and recording the metric for an olfactory threshold latency period, the metric measuring the number of breaths taken by the patient between the introduction of the pure-odorant infused air to the reaching of the pure odorant detection threshold for each introduction of the pure odorant-infused air to the second nostril;comparing the measured and recorded metrics for the olfactory threshold latency period recorded for the left nostril with the measured and recorded metrics for the olfactory threshold period recorded for the right nostril;determining whether the olfactory threshold latency period measured for the left nostril statistically differs from the olfactory threshold latency period measured for the right nostril; andconcluding that the patient's left olfactory lobe has more damage than the patient's right olfactory lobe if the olfactory threshold latency period measured for the left nostril is statistically greater than the olfactory threshold latency period measured for the right nostril. 2. The method of claim 1, wherein the measured and recorded metric for the olfactory threshold latency period further comprises the elapsed time required by the patient to reach the pure odorant detection threshold for each introduction of pure odorant-infused air in the established introduction order. 3. The method of claim 1, wherein the pure odorant detection threshold consists of the point at which the concentration of pure odorant molecules for each one of the pure odorants introduced saturate the patient's olfactory nerve to the extent that a cognitive reaction occurs in the patient. 4. The method of claim 1, further comprising each pure odorant comprising a substance that stimulates the olfactory cell receptors of the first cranial nerve and that do not stimulate the fifth cranial nerve. 5. The method of claim 1, further comprising: switching from presenting a first pure odorant air flow to one of the patient's nostrils upon cognitive notice of the first pure odorant by the patient indicating reaching of the pure odorant detection threshold for the first pure odorant with the nostril; andpresenting without delay a second pure odorant air flow to the 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. 6. The method of claim 1, further comprising summing of each of the measured and recorded metrics for the olfactory threshold latency periods measured in the number of breaths taken by the patient for each of the left and right nostrils. 7. The method of claim 6, further comprising comparing the summed metric for the olfactory threshold latency periods for the left nostril with the summed metric for the olfactory threshold latency periods for the right nostril and determining whether the left nostril's olfactory threshold latency period statistically differs from the olfactory threshold latency period for the right nostril. 8. The method of claim 7, further comprising concluding that the patient's left olfactory lobe has more damage than the patient's right olfactory lobe if the olfactory threshold latency period for the left nostril is statistically greater than the olfactory threshold latency period for the right nostril. 9. The method of claim 7, further comprising concluding that the patient's left olfactory lobe is not damaged relative to the patient's right olfactory lobe if the olfactory threshold latency period for the left nostril is not statistically greater than the olfactory threshold latency period for the right nostril. 10. 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. 11. The method of claim 1, further comprising providing a device to introduce the at least two pure odorants in pure odorant infused-air to each of the patient's nostrils. 12. The method of claim 11, the device further comprising oleophobic airways. 13. The method of claim 11, 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 substantially 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, 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. 14. The method of claim 12, 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 13, 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 only through the aligned pure odorant chamber to create the pure odorant-infused air for presentation to the nasal tip. 16. The method of claim 15, 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 nostril upon the patient's cognitive notice of the first pure odorant, indicating the patient has reached the pure odorant detection threshold for the nostril and the first pure odorant; andpresenting 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 patient's nostril, and without aid of a reset period interposed between presentation of the first pure odorant infused air and the presentation of the second pure odorant infused air to the patient's nostril until the patient's cognitive notice of the second pure odorant indicating the patient has reached the pure odorant detection threshold for the nostril and the second pure odorant. 17. The method of claim 15, wherein at least one chamber of the pure odorant cartridge contains no pure odorant and is, therefore blank. 18. The method of claim 17, further comprising ruling out pure odorant contamination of the device if the patient cannot smell a pure odorant when the blank chamber of the pure odorant cartridge is aligned with the patient's nostril. 19. The method of claim 11, the device further comprising a bilateral visual indication that airflow is present to ensure valid results. 20. The method of claim 7, wherein the pure odorant detection metric further comprises: summing, for each of the patient's left and right nostrils, the measured and recorded metrics for the olfactory threshold latency periods measured in seconds elapsed required by the patient to reach cognitive notice of each of the presented pure odorants;comparing the summed pure odorant metrics metrics comprising elapsed time for the olfactory threshold latency periods for the left nostril with the summed metrics for the olfactory threshold latency periods comprising elapsed time for the right nostril and determining whether the left nostril's summed pure odorant metric olfactory threshold latency period statistically differs from the summed pure odorant metric olfactory threshold latency period for the right nostril;concluding that the patient's left olfactory lobe has more damage than the patient's right olfactory lobe if the summed pure odorant metrics comprising elapsed time for the olfactory threshold latency period for the left nostril is statistically greater than the summed pure odorant metrics comprising elapsed time for the olfactory threshold latency period for the right nostril; andconcluding that the patient's left olfactory lobe is not damaged relative to the patient's right olfactory lobe if the summed pure odorant metrics comprising elapsed time for the olfactory threshold latency period for the left nostril is not statistically greater than the summed pure odorant metrics comprising elapsed time for the olfactory threshold latency period for the right nostril. 21. The method of claim 20, comprising concluding that the patient's left olfactory lobe is not damaged relative to the patient's right olfactory lobe if either of the summed pure odorant metrics comprising elapsed time or breaths for the olfactory threshold latency period for the left nostril is not statistically greater than the summed pure odorant metrics comprising elapsed time or breaths for the olfactory threshold latency period for the right nostril. 22. The method of claim 20, comprising concluding that the patient's left olfactory lobe is damaged relative to the patient's right olfactory lobe if the summed pure odorant metrics comprising elapsed time for the olfactory threshold latency period for the left nostril is statistically greater than the summed pure odorant metrics comprising elapsed time for the olfactory threshold latency period for the right nostril, or if the summed pure odorant metrics comprising breaths for the olfactory threshold latency period for the left nostril is statistically greater than the summed pure odorant metrics comprising elapsed time for the olfactory threshold latency period for the right nostril.
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