Method for external ear canal pressure regulation to alleviate disorder symptoms

Inventors

Sullivan, David Brice

Assignees

Nocira LLC

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Publication Number

US-12102506-B2

Patent

Publication Date

2024-10-01

Expiration Date


Abstract

A method for external ear canal pressure regulation to alleviate one or more symptoms associated with a disorder or treat one or more disorders, the method including providing a fluid transfer device which generates a fluid flow of a fluid through an earplug, the earplug having an earplug external surface configured to sealably engage an external ear canal wall as a barrier between an external ear canal pressure and an ambient pressure; sealably engaging the earplug of the fluid transfer device with the external ear canal wall as the barrier between the external ear canal pressure and the ambient pressure; and operating the fluid transfer device to generate the fluid flow of the fluid through the earplug to achieve an external ear canal pressure differential between the external ear canal pressure and the ambient pressure effective to alleviate a disorder symptom or treat a disorder.

Core Innovation

The invention is a non-pharmaceutical method for alleviating migraine headache pain being experienced by a patient. The method engages a first ear on a first side of the head with an earpiece to allow a first pressure in a first external ear canal to be adjusted, and fluid flow through the earpiece is controlled to make at least one pressure adjustment that generates at least one pressure differential between the first pressure and ambient pressure outside the external ear canal.

The method observes a response of the migraine headache pain to the at least one pressure adjustment. The observed response comprises a change in headache pain distribution that results in a higher degree of headache pain on the second side than on the first side of the patient’s head, and based on the observed response the method makes at least one additional pressure adjustment to a second pressure in a second external ear canal of the second ear to create at least one second pressure differential versus ambient pressure.

In described embodiments, pressure adjustment is produced by controlling a flow of fluid through the earpiece, including manipulating an insufflator bulb of an ear insufflation device, and sustaining a pressure differential and then returning the first pressure to ambient pressure before repeating. The therapeutic physiological response is described as comprising an afferent nerve signal into a brain and/or a deflection of a tympanic membrane in at least one of the first ear or the second ear.

Claims Coverage

Two independent claims are identified (clm-00001 and clm-00017). The claims include five inventive features centered on bilateral ear pressure adjustment, observed headache pain distribution, and a therapeutic physiological response.

Bilateral ear pressure differential guided by headache pain distribution

Engaging the first ear on the first side with an earpiece to adjust a first pressure in a first external ear canal, generating at least one pressure differential between the first pressure and ambient pressure, observing a change in headache pain distribution with higher pain on the second side, and then making at least one additional pressure adjustment to a second pressure in a second external ear canal to create a second pressure differential versus ambient pressure.

Non-pharmaceutical therapeutic physiological response from ear canal pressure differential

Configuring the method to cause a physiological response that is therapeutic for alleviating the migraine headache pain based on the observed migraine headache pain response.

Stopping first flow before additional pressure adjustment to the second ear

Stopping the first flow of fluid through the earpiece after generating the first pressure differential, then controlling a second flow of fluid to make at least one additional pressure adjustment in the second external ear canal to generate a second pressure differential versus ambient pressure.

Afferent nerve signal into the brain as therapeutic physiological response

Configuring the method so that the therapeutic physiological response comprises an afferent nerve signal into a brain of the patient.

Tympanic membrane deflection as therapeutic physiological response

Configuring the method so that the therapeutic physiological response comprises a deflection of a tympanic membrane in at least one of the first ear or the second ear.

The claim coverage centers on adjusting ear canal pressure via fluid flow to create pressure differentials relative to ambient pressure, observing migraine headache pain distribution changes to identify the side with higher pain, and applying an additional pressure adjustment to the other ear to achieve a therapeutic physiological response. The response is described as involving an afferent nerve signal to the brain and/or deflection of the tympanic membrane, and one independent claim includes stopping the first fluid flow before applying the second ear adjustment.

Stated Advantages

Alleviating migraine headache pain by a non-pharmaceutical method.

Documented Applications

Not explicitly described in patent.

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