“Electrode Member, Head Orthosis, Body Orthosis, And Wear Set” in Patent Application Approval Process (USPTO 20240115179): Patent Application

2024 APR 30 (NewsRx) -- By a News Reporter-Staff News Editor at Insurance Daily News -- A patent application by the inventor NAKATSUGAWA, Shigekazu (Tokyo, JP), filed on February 1, 2022, was made available online on April 11, 2024, according to news reporting originating from Washington, D.C., by NewsRx correspondents.

This patent application has not been assigned to a company or institution.

The following quote was obtained by the news editors from the background information supplied by the inventors: “In recent years, the situation surrounding human beings is changing drastically, such as climate extremes due to environmental destruction caused by global warming, widening of disparities in all aspects due to the global economy, the possibility of war due to the intensification of conflict between the United States and China, and fear of death, particularly in the elderly and people with chronic diseases, due to the global spread of the new coronavirus. The disparity extends not only to economic power, nutrition, and education, but also to exercise, information acquisition; processing capability, and the like. In other words, it is no exaggeration to say that we are in the midst of a whirlwind of unprecedented upheaval. Under such circumstances, it is quite difficult for people to maintain good sleep sufficient in both quality and quantity, which is important for maintaining the mental calmness and physical health.

“The life (daily activities) of people consists of about 34 to 50% in length of social activities outside of home, about 17 to 33% in length of home life, the remaining about 33% in sleep time, and is regulated by the body clock. It has been found that sleep, during which the memory is fixed, also plays a major role in maintenance of visceral function, and is essential for improving productivity. In a sense; activities other than sleep time are supported by, for example, the mind and the physical environment, that is, nutrition, exercise, sleep, lifestyle, memory; purpose of life, and the like, and conversely, the quality and quantity of sleep depend on the physical or psychological fatigue, stress, psychological state, other social activities, nutrition, exercise, lifestyle, and the like.

“In addition, it is also known that sleep has large individual differences such as a change in body temperature, a balance of a heat release amount (sweating ability, etc.) together with a calorific value (exercise amount, meal contents, etc.), and is greatly affected by a climate of a living area, that is, an environment such as temperature, humidity, sound, and light. Regarding individual differences, large differences are generated in a wide range of areas such as individual body composition, in particular, muscle mass related to calorific value, cardiovascular system and nervous system related to skeleton, heat dissipation, and sweating, degree of development and aging of internal organs, combination of lifestyle diseases, balance between immunity and endocrine system, and quality, amount and contents of work.

“Furthermore, in a case where the sleep time itself is shorter than 5 hours, in a case where the nap is 30 minutes or more, and in a case of sleep apnea syndrome or the like, it is known that the risk of sleep disorder and lifestyle diseases such as diabetes is high, and thus, the importance of the modulation mechanism of the autonomic nerve related to the biological clock is known, and it is suggested that the importance of ensuring a deep sleep time that continues nasal respiration that can make the parasympathetic nerve dominant. In this sense as well, it can be said that the know-how to realize good sleep including the sleep apnea syndrome treatment method (therapy for upper-airway restoration and maintenance: hereinafter referred to as “TURM”) is essential in this era in which it is difficult to avoid the anxiety of living with-corona.

“On the other hand, for reliable good sleep and falling asleep again, effects of acupuncture treatment including general massage have been known from long ago. In addition, in an uneasy psychological state such as lack of exercise, excessive eating, and high stress, and an increasing shift work and irregular work, waking up during sleep and early awakening frequently occur, and it is often difficult to fall asleep again. However, in recent years where the coronavirus infection continues, head massage or the like essentially needs a practitioner and is not realistic to be applied to sleep every night. Therefore, there is a demand for a methodology by which the user himself/herself produces an effect of falling asleep or re-falling asleep with the parasympathetic nerve dominance that can be relaxed similarly to the acupuncture treatment from an excitation activity state with the sympathetic nerve dominance.

“As for not only sleep apnea syndrome (SAS) but also an overnight polygraph test (hereinafter referred to as “PSG test”) known as a final test related to sleep, in our country, health insurance treatment fees have been significantly reduced since last spring, which incurs a large deficit against the required labor, and therefore facilities that stop the PSG test have been increased. As a result, it is socially difficult to diagnose SAS for which early detection and early treatment are desired, and it is expected that the PSG test will be strongly demanded to be carried out without labor cost and consumables cost.

“In the PSG test, the following configurations are considered.

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“1) Electroencephalogram Frontal (F3, F4 as defined in the international 10-20 system): useful in determining delta waves appearing in deep sleep. Central (C3, C4 as defined in the international 10-20 system): optimal for observation of aneurysm wave or parietal sharp wave, sleep spindle wave, K compound and a wave as an index of awakening.

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“Occipital (C1, C2 as defined in the international 10-20 system): to ensure determination of wakefulness (observing a waves).

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“2) Electrooculogram (derivation of changes in potential due to eye movement) important for differentiating stage R (REM sleep). Sleep onset can be predicted from gradual eye movement.

“3) Jaw electromyogram of the jaw important for differentiating between wakefulness and REM sleep.

“4) Electrocardiogram: to record heart rate, heart rate variability, arrhythmia, change in ST-T, and the like.

“5) Arterial oxygen saturation (SpO2): important for determining apnea/hypopnea and determining the severity of sleep disordered breathing.

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“SpO2 is measured using a pulse oximeter.

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“6) Respiration curve: important for classification of obstructive, central and mixed apnea and evaluation of hypopnea. The respiration curve requires measurement of air flow from the nostril and mouth and movement of the chest and abdomen.

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“As the nose/mouth sensor, it is recommended to use a temperature sensor (thermistor method, thermocouple method) that senses a temperature change of the airflow, a detection sensor for hypopnea determination, and a pressure transducer (air pressure method) that detects an airflow change from a pressure difference as a detection sensor for apnea determination.

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“7) Snoring sound: a snoring sound is recorded with an acoustic sensor (such as a microphone).

“8) Body position: In ° SAS, there are an example in which the severity is reduced by sleeping in a lateral position and an example in which the severity is exacerbated by sleeping in a supine position, which are information useful for treatment.

“9) Lower limb electromyogram: important for determining periodic limb movement (PLM). The tibialis anterior is used for the lower limb electromyogram.

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“As a PSG test device, for example, the technology of Patent Literature 1 has been proposed. Patent Literature 1 describes a device including a head orthosis for PSG test including an electroencephalogram electrode for acquiring an electroencephalogram of a user, an electrooculogram electrode for acquiring an electrooculogram of the user, and an oxygen saturation sensor for acquiring oxygen saturation of the user.”

In addition to the background information obtained for this patent application, NewsRx journalists also obtained the inventor’s summary information for this patent application: “SUMMARY:

“Technical Problem

“However, in the PSG test in a case where a user is highly obese or sebum or the like adheres to the body surface such as scalp of the user, it is difficult to capture a weak current such as electroencephalogram separated by cerebrospinal fluid or skull. Therefore, in a case of using the PSG test device or the like described in Patent Literature 1, it is necessary to remove sebum or makeup of the user before the test, which takes time and effort. In addition, when the PSG test is carried out, apnea and hypopnea during sleep may be less likely to occur if the sleep is shallow, and thus it is considered that a device for inducing the user to sleep is also necessary.

“In addition, there is a strong demand for a head orthosis, a body orthosis, and the like by which the user himself/herself produces an effect of falling asleep or re-falling asleep with the parasympathetic nerve dominance that can be relaxed similarly to the acupuncture treatment from an excitation activity state with the sympathetic nerve dominance.

“The present invention has been made in view of the above circumstances, and an object of the present invention is to provide an electrode member, a head orthosis, a body orthosis, and a wear set that can reliably perform PSG test while suppressing the cost and the inspection labor.

“Solution to Problem

“In order to solve the above problems, an electrode member of the present invention is an electrode member to be attached to a body surface of a user, and includes;

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“an adhesion part including a through hole near a center and capable of adhering to a body surface of a user;

“an electrode inserted into the through hole of the adhesion part; and

“a first retention part configured to retain a solution for dissolving sebum, in which

“a flow channel including a gap is formed between an inner peripheral surface of the through hole of the adhesion part and the electrode, and

“the solution for dissolving sebum retained in the first retention part is able to flow out from one end side of the through hole through the flow channel.

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“A head orthosis of the present invention includes the electrode member and a head mounted member.

“A body orthosis of the present invention includes the electrode member and a body mounted member.

“The wear set of the present invention is characterized by including a head orthosis and a body orthosis.

“Advantageous Effects of Invention

“With the electrode member, the head orthosis, the body orthosis, and the wear set of the present invention, it is possible to reliably perform the PSG test while reducing the cost and the time and effort for the test, and it is possible to reliably promote good sleep and re-falling asleep by the alternative therapeutic effect of the acupuncture treatment.”

The claims supplied by the inventors are:

“1. An electrode member to be attached to a body surface of a user, comprising: an adhesion part including a through hole near a center and capable of adhering to a body surface of a user; an electrode inserted into the through hole of the adhesion part; and a first retention part configured to retain a solution for dissolving sebum, wherein a flow channel including a gap is formed between an inner peripheral surface of the through hole of the adhesion part and the electrode, and the solution for dissolving sebum retained in the first retention part is able to flow out from one end side of the through hole through the flow channel.

“2. The electrode member according to claim 1, wherein the adhesion part includes a first concave portion formed around the one end side of the through hole and connected to the flow channel, and the solution for dissolving sebum is sent from the first retention part to the first concave portion through the flow channel.

“3. The electrode member according to claim 2, wherein the adhesion part includes a second concave portion formed around the first concave portion and adheres to a body surface of a user via the second concave portion.

“4. The electrode member according to claim 1, wherein the first retention part is provided on another end side of the through hole.

“5. The electrode member according to claim 1, further comprising a second retention part configured to retain an electrolyte gel, wherein the electrolyte gel is able to flow out from the one end side of the through hole from the second retention part through the flow channel.

“6. The electrode member according to claim 1, wherein the electrode member is used for massage or for PSG test.

“7. A head orthosis comprising: the electrode member according to claim 1; and a head mounted member.

“8. The head orthosis according to claim 7, wherein the head mounted member includes a moisture absorbing layer configured to come in contact with a head surface, and an insulating layer laminated on the moisture absorbing layer.

“9. The head orthosis according to claim 8 comprising a conductive wire connected to an electrode of the electrode member, wherein in the conductive wire, a mesh structure in which units of a substantially regular hexagon in a front view are continuous is formed, and a surface of the head mounted member on a side of the insulating layer is covered with the conductive wire.

“10. A body orthosis comprising: the electrode member according to claim 1; and a body mounted member.

“11. The body orthosis according to claim 10, wherein the body mounted member includes a moisture absorbing layer configured to come in contact with a body surface, and an insulating layer laminated on the moisture absorbing layer.

“12. The body orthosis according to claim 11 comprising a conductive wire connected to an electrode of the electrode member, wherein in the conductive wire, a mesh structure in which units of a substantially regular hexagon in a front view are continuous is formed, and a surface of the head mounted member on a side of the insulating layer is covered with the conductive wire.

“13. (canceled)

“14. A wear set comprising a head orthosis, a body orthosis, and an electrode member attached to a body surface of a user, wherein the head orthosis comprises a head mounted member and the body orthosis comprises a body mounted member, and wherein the electrode member comprises: an adhesion part including a through hole near a center and capable of adhering to a body surface of a user; an electrode inserted into the through hole of the adhesion part; and a first retention part configured to retain a solution for dissolving sebum, wherein a flow channel including a gap is formed between an inner peripheral surface of the through hole of the adhesion part and the electrode, and the solution for dissolving sebum retained in the first retention part is able to flow out from one end side of the through hole through the flow channel.”

URL and more information on this patent application, see: NAKATSUGAWA, Shigekazu. Electrode Member, Head Orthosis, Body Orthosis, And Wear Set. U.S. Patent Application Number 20240115179, filed February 1, 2022 and posted April 11, 2024. Patent URL (for desktop use only): https://ppubs.uspto.gov/pubwebapp/external.html?q=(20240115179)&db=US-PGPUB&type=ids

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