“Tetherless Wearable Thermal Devices and Methods of Using Them for Treatment of Sleeping and Neurological Disorders” in Patent Application Approval…

"Tetherless Wearable Thermal Devices and Methods of Using Them for Treatment of Sleeping and Neurological Disorders" in Patent Application Approval Process (USPTO 20170333667)

By a News Reporter-Staff News Editor at Politics & Government Week -- A patent application by the inventor TUCKER, Robert E. (Sanibel, FL), filed on May 16, 2017, was made available online on November 30, 2017, according to news reporting originating from Washington, D.C., by VerticalNews 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: "Sufficient and high-quality sleep is important for an individual's physical, mental, and emotional health. Despite various drugs and devices on the market for enhancing sleep and treating sleep disorders, disruption and irregularities, including insomnia, resulting in poor sleep is a widespread and pervasive problem. For example, previously described devices and techniques for the treatment of sleep disorders have included the use of cooling therapies, including applying cooling therapy to a patient's forehead, to enhance sleep. This has been described, for example, in U.S. Pat. No. 8,425,583, and U.S. Pat. No. 8,236,038, each of which are herein incorporated by reference in their entirety. Thus, there is evidence for enhancing sleep by cooling a subject's skin (e.g., forehead), perhaps by taking advantage of a mechanism involving cooling an underlying brain region. There is also recent work by these inventors suggesting that warming may also result in sleep enhancement, particularly warming relative to ambient temperature. The mechanism of action that temperature has on sleep has not been conclusively identified.

"In general, studies have suggested that the control of sleep and thermoregulation (regulation of body temperature) are integrated at the level of the hypothalamus in the brain. Human studies have shown that manipulation of environmental temperature by various means can have an impact on sleep, however it is not well understood how selective regions of the body can influence hypothalamic sleep and thermoregulatory centers. Clinical insomnia and sleeplessness in general are characterized by transient or chronic difficulty initiating and maintaining sleep. It is unclear if alterations in thermoregulation play a significant role in the pathophysiology or treatment of insomnia or sleeplessness. Physiological and neuroanatomical studies show that the forehead is a region of the body that has unique properties and suggesting that it may play a prominent role in impacting the hypothalamic control of thermoregulation and, by extension, may influence hypothalamic thermoregulatory control of sleep.

"Insomnia is often described as the inability to fall asleep easily, to stay asleep, or to experience quality sleep in an individual with adequate sleep opportunity. In the U.S., population-based estimates of either chronic (long-term) or transient (acute or short-term) insomnia range from 10% to 40% of the population, or 30 to 120 million adults. Similar prevalence estimates have been reported in Europe and Asia. Across studies, there are two age peaks for insomnia: 45-64 years of age and 85 years and older. Women are 1.3 to 2 times more likely to report trouble sleeping than men, as are those who are divorced or widowed, or have less education. In the U.S., the economic burden of insomnia approaches $100 billion in direct health care costs, functional impairment, increased risk of mental health problems, lost productivity, worker absenteeism, and excess health care utilization. Insomnia is recognized as a public health problem, contributing to more than twice the number of medical errors attributed to health care workers without insomnia episodes. Currently available treatments for insomnia are not satisfactory for a variety of reasons. Prescription drugs (e.g., sedative-hypnotics) that are given for insomnia treatment are associated with significant adverse events such as the potential for addiction/dependence, memory loss, confusional arousals, sleep walking, and problems with coordination that can lead to falls and hip fractures. The majority of insomnia patients prefer a non-pharmaceutical approach to treat their insomnia. Cognitive behavior therapy, while sometimes effective, is an expensive and labor intensive treatment that is not widely available and is not always covered by health insurance. Over-the-counter approaches to the treatment of insomnia include a variety of medications and devices that have not solved sleep problems, and inadequate clinical studies that fail to demonstrate significant effects in insomnia patients, as well as having potentially dangerous side effects. A large need exists, therefore, for a safe, effective, non-invasive treatment for treating sleep disorders and enhancing sleep.

"Normal sleep cycles through different stages. The induction, maintenance and timing of wake, non-rapid eye movement sleep (NREM) or slow wave sleep (SWS), and rapid eye movement (REM) sleep stages are the result of complex interactions among multiple structures and mechanisms which are widely distributed throughout the brain. Reciprocal interactions between sleep and wake promoting systems ensure that the behavioral state of sleep-wakefulness is altered as required. Prominent among these sleep-promoting structures are the pontine tegmentum and adjacent neuronal groups in the brain that are involved in the generation of REM sleep features. On the other hand, NREM sleep is promoted by several areas in the brain, including the medial preoptic area (mPOA), the lateral preoptic area (lPOA), the ventrolateral preoptic area (vlPOA), the median preoptic nucleus (mnPO), and the medial septum, which are referred to as basal forebrain (BF) areas. External and internal factors influence the swing of sleep-wakefulness toward either sleep or awake state. The basal forebrain plays a role in integrating thermoregulation and sleep regulation.

"Body temperature regulation (thermoregulation) is a fundamental homeostatic function that is regulated by the central nervous system. The preoptic area (or POA) of the hypothalamus is considered the most important thermoregulatory site in the brain on the basis of thermoregulatory studies, such as responses elicited by local warming and cooling, analysis of lesions, results from stimulation and single neuronal recording, and other techniques. Thermoregulation in the preoptic area is controlled by thermosensitive neurons. The thermosensitive neurons in the POA receive and integrate cutaneous (skin) and deep body thermal information. These neurons are tonically active at thermoneutral temperature, and control the thermoregulatory efferent pathway.

"The concept of the POA as a sleep-promoting area and the posterior hypothalamus as a wake promoting area is supported by several lines of animal experiments employing stimulation, lesion studies, single unit recording, neural transplantation, functional magnetic resonance imaging (fMRI), and c-fos studies. The neural mechanism involved in the regulation of sleep and temperature and their interrelationship has been explored in various studies.

"A thermoreceptor may be a peripheral thermoreceptor (e.g., a receptor on the skin or mucous membranes of a subject that monitors external temperature) or a central thermoreceptor (e.g., an internal receptor that monitors internal body temperature). The preoptic area of the hypothalamus contains temperature sensitive neurons (warm sensitive neurons (WSN) and cold sensitive neurons (CSN)). These neurons were identified in the preoptic area on the basis of in vivo and in vitro studies. Warm sensitive neurons are directly sensitive to (and fire in response to) locally warm temperatures and cold sensitive neurons are directly sensitive to (and fire in response to) local cool temperatures.

"Several studies indicate that both ambient and body temperatures influence sleep architecture. The thermoregulatory pathway which initiates a heat or cold defense response in the body is conveyed by skin thermoreceptors, en route dorsal horn, and parabrachial nuclei, to the POA. Much attention has been given to the physiological role of the POA because of its ability to control both thermoregulation and sleep. Many of the observations cited earlier support the hypothesis that sleep is modulated by thermosensitive neurons of the POA. Although this relationship has drawn considerable interest, it is still not known whether there is a 'cause and effect' relationship or whether these changes are merely coincidental. Notably, studies of skin temperature in insomnia patients have focused on distal skin temperatures in the feet and hands. Whether there are other more temperature sensitive regions of the body that can transmit temperature sensitive information to the POAH is not known.

"Among body regions, the forehead has unique physiological and neuroanatomical properties that suggest it may play a prominent role in influencing the thermoregulatory hypothalamic modulation of sleep. The distribution of warm and cold spots has been shown to be highest over the face and forehead of all body parts Thermal sensation has been shown to be highest in the forehead of all body parts. Further, the forehead comprising glabrous (non-hairy) skin has been shown to play a prominent role in the body response to thermoregulation given that the heat transfer function and efficacy of glabrous skin is unique within the entire body based on the capacity for a very high rate of blood perfusion and the novel capability for dynamic regulation of blood flow. Despite extensive research, it is still not well understood how sleep is controlled, and sleep disorders including insomnia, remain a significant problem for a large number of people.

"Described herein are methods and apparatuses capable of stimulating a response in a subject's body to improve sleep in the subject. These methods, systems and devices may stimulate temperature sensitive receptors (e.g., cold sensitive or warm sensitive neurons) in a subject's skin to enhance the subject's sleep. In particular, the apparatuses and methods described herein may use a tetherless (e.g., self-contained), wearable device (e.g., wearable on a forehead) apparatus that may be useful to decrease sleep onset (e.g., facilitate falling to sleep), decrease arousals, increase sleep duration, increase depth of sleep, and/or treat insomnia)."

In addition to the background information obtained for this patent application, VerticalNews journalists also obtained the inventor's summary information for this patent application: "Described herein are apparatuses and methods, including methods of using the apparatuses, to enhance sleep. Enhancing sleep may include one or more of: reducing sleep onset latency, extending sleep duration, reducing awakenings, and/or increasing the duration of deeper sleep stages relative to stage 1 sleep in a subject (e.g., increasing the ratio of deeper sleep stage duration relative to stage 1 sleep duration). These apparatuses and methods may be applied to subjects (e.g., persons, patients, etc.) in need thereof; for example, the methods described herein may be used to treat a subject suffering from a sleeping disorder such as insomnia. In general, these apparatuses and methods apply (and may maintain) stimulation of temperature-sensitive receptors in a subject's body (skin) and through the receptor provide signals that enhances the subject's sleep. Any of the apparatuses and methods of using them described herein may be configured to apply heat and/or cooling to a subject's forehead using a self-contained (e.g., tetherless) apparatus.

"For example, described herein are apparatuses for applying thermal energy to a subject's forehead to enhance sleep, the apparatus comprising: a conformable body configured to be worn on the subject's forehead having a skin-facing surface; a plurality of thermoelectric temperature regulators arranged across the skin-facing surface; a controller configured to apply power to cool the thermoelectric temperature regulators to between 1.degree. C.-30.degree. C.; and a holdfast configured to secure the apparatus to the subject's forehead.

"The holdfast may be a strap, hat, headband, adhesive, or the like.

"Any of these apparatuses may include one or more sensors. The sensor(s) may be configured to collect data from the subject and transit this data (wired or wirelessly) to the controller/processor in the apparatus, or a remote processor that is in communication with the controller in the wearable apparatus. The data may be used by the controller/processor to determine the sleep state of the subject wearing the device (e.g., awake, NREM (stage 1, 2 or 3), REM sleep, etc.), determine if the subject is wearing the apparatus and/or determine the parasympathetic status of the subject.

"Modulation of the parasympathetic nervous system may be used to reduce sleep onset and maintain sleep. One manner in which the autonomic nervous system can be modulated is through the primitive autonomic nervous system reflex known as the diving reflex. The diving reflex is triggered by immersion of the body in cold water, and is characterized by a reduction in heart rate (HR) due to an increase in cardiac vagal activity, a primary efferent of the parasympathetic nervous system; this is often associated with vasoconstriction of selected vascular beds, due to increased sympathetic output to the periphery. Thus, any of the apparatuses and methods described herein may be configured to induce a diving reflex response in a patient wearing the apparatus by providing cooling to the forehead of the patient (including local, spot cooling). Sensors that may detect the parasympathetic state (e.g., heart rate, heart rate variability, etc.) may therefore also be used to modulate the applied cooling therapy and toggle between cooling and standby temperatures.

"Thus, any of these apparatuses may include a sensor configured to detect one or more of the subject's autonomic state and the subject is sleep/wake state. The sensor may be an accelerometer integrated into the conformable body (e.g., detecting body position and/or motion, which may also be used to derive sleep state or simply sleep/awake status). The sensor may be configured to detect one or more of: body movement, respiratory rate, heart rate, electrocardiogram (ECG) signals, and electroencephalogram (EEG) signals.

"In general, the controller is further configured to apply the power to cool the thermoelectric temperature regulator to between 1.degree. C.-30.degree. C. In some variations, the controller may control the applied temperature during an active cooling phase for a predetermined time period (e.g., 10 minutes to 60 minutes, 10 minute to 45 minutes, etc. or any time between 10 minutes and 3 hours, which may be user selected or automatically determined), or until the apparatus detects that the user is asleep. The apparatus may then toggle into a standby state and may regulate the temperature at a standby temperature (e.g., between 26.degree. C. and 38.degree. C., between 28.degree. C. and 38.degree. C., between 30.degree. C. and 38.degree. C., etc. or within a few degree, e.g., +/-2.degree. C., of body surface/skin temperature). In some variations, the apparatus may apply the cooling in a ramp with decreasing temperature (e.g., decreasing from 30.degree. C. or 25.degree. C.) until the subject experiences a diving reflex, at which point the temperature may be sustained for a predetermined first treatment time period (e.g., 10 minutes to 60 minutes, 10 minute to 45 minutes, etc. or any time between 10 minutes and 3 hours).

"For example, a controller may be further configured to apply the power to cool the thermoelectric temperature regulator to between 1.degree. C.-30.degree. C. when the subject is awake. The controller may be further configured to apply power to the thermoelectric temperature regulators to maintain a standby temperature of between 26-38.degree. C. when the subject is asleep.

"Any of the apparatuses described herein may be battery powered (and/or rechargeable). For example, the apparatus may further comprise a battery. Any of these apparatuses may include a charging circuit and/or a charging antenna configured to recharge the battery from power inductively received by the charging antenna. The charging antenna may be configured to power the controller and the thermoelectric temperature regulators when power is received by the charging antenna.

"Any of these apparatuses may include a wireless communications circuit configured to wirelessly transmit and receive to and from the controller.

"In general, the controller may be configured to apply energy in a pulsatile manner so that the thermoelectric temperature regulators apply variably cooling to the forehead (e.g., varying between the cooling temperature and a temperature that is slightly higher than the cooling temperature). For example, the energy may be applied in pulses having a pulse duration of less than 360 seconds.

"Any of these apparatus may be configured for use with a cover, which may be removable or non-removable, having a thermally transmissive surface configured to be positioned over the skin-facing surface. For example, the cover may be a single-use cover to prevent dirtying of the device when worn and/or to help secure the device to the forehead.

"Also described herein are apparatuses for applying thermal energy to a subject's forehead to enhance sleep that include: a conformable body configured to be worn on the subject's forehead having a skin-facing surface; a plurality of thermoelectric temperature regulators arranged across the skin-facing surface; a sensor; a controller configured to receive sensor data from the sensor and to determine when the subject is sleeping or awake; further wherein the controller is configured to apply power to cool the thermoelectric temperature regulators to a first temperature of between 1.degree. C.-30.degree. C. when the patient is awake and to apply power to cool the thermoelectric temperature regulators to a standby temperature of between 26-38.degree. C. when the patient is asleep; and a holdfast configured to secure the apparatus to the subject's forehead.

"Also described herein are methods of enhancing sleep using a tetherless thermally-regulated applicator, the method comprising: optionally attaching the tetherless thermally-regulated applicator to a subject's forehead; determining when the subject is sleeping or awake based on sensor data received from one or more sensors in communication with a controller in the tetherless thermally-regulated applicator; applying power to cool a plurality of thermoelectric temperature regulators on the tetherless thermally-regulated applicator to a first temperature of between 1.degree. C.-30.degree. C. when the patient is awake; and decreasing the power to the thermoelectric temperature regulators and maintaining the tetherless thermally-regulated applicator at a standby temperature of between 26.degree. C.-38.degree. C. when the patient is asleep.

"Attaching may comprise attaching a holdfast to secure the tetherless thermally-regulated applicator to the subject's forehead.

"Determining if the subject is asleep or awake may comprise receiving data from one or more sensors integrated into the tetherless thermally-regulated applicator. For example, determining if the subject is asleep or awake may comprise receiving data from one or more sensors wirelessly communicating with the controller of the tetherless thermally-regulated applicator, wherein the one or more sensors are separate from the tetherless thermally-regulated applicator. Determining if the subject is asleep or awake may include determining if the subject is asleep or awake based on sensor data received from one or more sensors configured to detect one or more of: body movement, respiratory rate, heart rate, electrocardiogram (ECG) signals, and electroencephalogram (EEG) signals.

"Applying power to cool a plurality of thermoelectric temperature regulators on the tetherless thermally-regulated applicator to a first temperature may comprise applying power to the thermoelectric temperature regulators to cool to between 10.degree. C.-25.degree. C. when the patient is awake. Decreasing the power to the thermoelectric temperature regulators may comprise maintaining the tetherless thermally-regulated applicator at a standby temperature of between 32.degree. C.-38.degree. C. when the patient is asleep.

"Also described herein are method of enhancing sleep using a tetherless thermally-regulated applicator attached to a subject's forehead, the method comprising: applying power, using a controller in the tetherless thermally-regulated applicator, to a plurality of thermoelectric temperature regulators on the tetherless thermally-regulated applicator to cool a thermal transfer surface on the tetherless thermally-regulated applicator to a first temperature of between 1.degree. C.-25.degree. C. for a therapy period and decreasing the power applied to the thermoelectric temperature regulators after the first duration to maintain the tetherless thermally-regulated applicator at a standby temperature of between 26.degree. C.-38.degree. C. for a standby period. Optionally, the method may include cycling between the therapy period and the standby period.

"The therapy period may have a duration of greater than 10 minutes (e.g., greater than 15 minutes, greater than 20 minutes, greater than 30 minutes, greater than 40 minutes, greater than 45 minutes, greater than 1 hour, etc., including any value between 10 and 120 minutes).

"The therapy period may end when either the patient falls asleep or after a predetermined time period. The controller may monitoring the sleep state, but if the patient has not fallen asleep by the end of the therapy period, the controller may switch to the standby period. The predetermined time period is greater than 10 minutes (e.g., greater than 15 minutes, greater than 20 minutes, greater than 30 minutes, greater than 40 minutes, greater than 45 minutes, greater than 1 hour, etc., including any value between 10 and 120 minutes).

"The standby period may have a duration of greater than 10 minutes (e.g., greater than 15 minutes, greater than 20 minutes, greater than 30 minutes, greater than 40 minutes, greater than 45 minutes, greater than 1 hour, greater than 2 hours, greater than 3 hours, etc., including any value between 10 and 120 minutes). The standby period may end when the subject enters a new sleep state (e.g., awakens, transitions from NREM to REM, transitions within NREM from stage 1 to stage 2, stage 2 to stage 3, etc.).

"Thus, in any of these variations, the method may also include determining, in a processor in communication with the controller, that the patient is asleep or awake, and transitioning between the therapy period and the standby period when the patient falls asleep."

URL and more information on this patent application, see: TUCKER, Robert E. Tetherless Wearable Thermal Devices and Methods of Using Them for Treatment of Sleeping and Neurological Disorders. Filed May 16, 2017 and posted November 30, 2017. Patent URL: http://appft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PG01&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.html&r=1&f=G&l=50&s1=%2220170333667%22.PGNR.&OS=DN/20170333667&RS=DN/20170333667

Keywords for this news article include: Patents, Therapy, Epidemiology, Mental Health, Risk and Prevention.

Our reports deliver fact-based news of research and discoveries from around the world. Copyright 2017, NewsRx LLC