CN115955992A - Therapeutic device and method for improving body function - Google Patents

Abstract

Methods and therapeutic devices for non-invasively improving brain function, improving eye health, improving digestive system health, and improving immune function are described. The non-invasive means is selected from electrical stimulation, thermal stimulation, IR (infrared) radiation, mechanical stimulation or a combination thereof. In some embodiments, the methods and devices utilize stimulation of selected skin areas on the human body to achieve a desired therapeutic effect.

Description

Therapeutic device and method for improving body function

Cross Reference to Related Applications

This application is a continuation-in-part application of U.S. patent application 16/819,165 filed on 3/15/2020, patent application 16/819,165 claiming priority to U.S. provisional patent application 62/823,656 filed on 26/3/2019, the disclosure of which is incorporated herein by reference in its entirety as if fully set forth in the prior application disclosure. This application also claims rights and priority to U.S. provisional patent application 63/077,707, filed on 9/14/2020, U.S. provisional patent application 63/090,253, filed on 11/10/2020, and U.S. provisional patent application 63/111,066, filed on 8/11/2020. The entire disclosure of the prior application is considered to be part of the disclosure of the present application and is incorporated herein by reference.

Background

Dementia is a wide range of brain disorders that can lead to a long-term and gradual decline in thought and memory, severe enough to affect daily functioning. Other common symptoms include emotional problems, language difficulties, and reduced motivation. The basis for the diagnosis of dementia includes changes beyond a person's usual psychological functions and a greater decline in mental function than that of a person's normal aging. The most common type of dementia is alzheimer's disease, accounting for 50% to 70% of cases. Other common forms include vascular dementia, dementia with lewy bodies, frontotemporal dementia, hydrocephalus under normal pressure, dementia with parkinson's disease, and creutzfeldt-jakob disease. There is currently no known method of treating dementia. US patent application US20190126062A1 discloses devices, systems and methods for treating dementia or alzheimer's disease in a subject in need thereof using visual/auditory stimuli having a frequency of about 30Hz to about 50Hz, more particularly about 40Hz, that are non-invasively delivered to the subject to cause gamma wave oscillations in multiple brain regions of the subject, including the prefrontal cortex (PFC) and hippocampus.

Summary of The Invention

Methods and treatment devices are disclosed having non-invasive means for improving brain function, such as improving sleep and memory, and treating senile dementia, including Alzheimer's disease. The non-invasive means is selected from the group consisting of light stimulation, electrical stimulation, thermal stimulation, IR (infrared) radiation, mechanical stimulation (e.g. sound/vibration stimulation) or combinations thereof. In some embodiments, the present invention utilizes an electric current through the skin, including acupuncture sites on the human head or hand, to achieve desired therapeutic and beneficial effects. It also provides methods and devices for improving sleep quality, including inducing deep sleep patterns such as slow wave sleep, improving eye health, improving digestive system health, and enhancing immune function.

In some embodiments, the devices and methods of the present invention are directed to stimulating one or more areas, including acupuncture points selected from the group consisting of wrist, waist, arm, neck, head, face, forehead, hand, foot, finger, toe, palm, sole of the foot, including the sun (EX-HN 5), sunny, indian hall, baihui (DU/GV 20), machining (EX-HN 1), fengchi (GB 20), and shenting (DU/GV 24), with the purpose of improving brain function and treating senile dementia, including alzheimer's disease. Preferably, the device of the present invention is portable and self-contained, having a structural device attachable to the head or other body part. It may be in the form of a hat or hair band, or it may be in the form of glasses or a helmet. The device may generate electrical pulses or heat or light or infrared radiation or vibration or sound or a combination thereof and apply them to the skin area, such as the target acupuncture points.

In some embodiments, light and/or electrical stimulation is also applied to the inner surface of the ear area or nose or eyes or eyelids. Devices that can deliver these stimuli (e.g. electrodes, light sources, shapes/forms with ear muffs/ear inserts/ear plugs or nose masks/nose inserts or eye masks/glasses) are also included within the device.

In one aspect, the methods and devices described in this invention use electrical pulses or electrical pulses in combination with vibration/sound or heat or light, such as infrared IR radiation, applied to the body region and/or the acupuncture points or other areas of the head to achieve the desired therapeutic effect. Persons desiring improved brain function (e.g., delayed aging, improved memory and sleep, improved blood flow, improved brain metabolism and detoxification, reduced brain dysfunction, reduced cognitive dysfunction, improved learning, improved reasoning and problem solving, improved sensory processing, improved brain tissue growth, improved neuronal/neural integrity, growth, function, activity and function, or treatment of dementia, such as alzheimer's disease or vascular dementia) place electrodes on one or more regions and acupoints selected from the group consisting of wrist, waist, arm, hand, palm, neck, head, face, forehead, hand, foot, finger, toe, palm, sole, temple, yangbai, itangtang, baihui, sishenclent, fengchi, shenting). Heat and/or light and/or infrared and/or vibration and/or sound stimuli generated by the device may also be applied to these areas and acupuncture points for these purposes to improve brain function and/or alleviate symptoms of dementia. The same devices and methods can also be used to treat depression and insomnia, and to improve sleep, including inducing deep sleep, such as slow wave sleep, which will also improve memory consolidation and improve cerebrospinal fluid flow, thereby clearing metabolites and toxic waste products (e.g., amyloid) from the brain to improve brain health. The stimulation pulse generating circuitry and power source may be conveniently packaged in a housing structure with structural means for attachment to the head or other body part, such as a hat or helmet shaped structure. One or more electrodes are located on an inner surface of the housing that is in contact with the skin. The device is positioned such that the one or more electrodes cover a targeted skin area or acupuncture point known to affect the desired treatment. Alternatively, the device is placed so that the electrodes are close to or cover the nerves extending below the acupuncture points, in which case the device may be placed at a distance from the relevant acupuncture points so that the device may be comfortably placed. It may also be attached to other areas of the head or other body areas.

The device may also contain one or more built-in heating elements that can maintain the temperature of the skin contact surface between 40 and 60 degrees to provide a heating effect to the stimulation site/area. The device may also contain one or more built-in visible and/or Infrared (IR) radiating elements that can generate and deliver light to the skin contact surface to provide a visible and/or infrared stimulating effect to the stimulation site/area, as well as a means of providing mechanical (e.g., sound) stimulation.

Brief description of the drawings

Fig. 1 shows examples of stimulation frequencies for cyclic mode (1 a), amplitude and frequency modulated wave (1 b) and pulse width modulation (1 c).

Fig. 2 shows an example of a block circuit diagram suitable for a device with or without an additional heating element.

Fig. 3 shows an example of a block circuit diagram suitable for an apparatus having electrodes, a heating element, a speaker and a vibrator.

Fig. 4 shows an example of a device electrode assembly.

Fig. 5 shows an example of another type of electrode assembly.

Fig. 6 shows an example of an electrode assembly having a heating element.

Fig. 7 shows an example of an electrode assembly having a light-radiating member.

Fig. 8 shows an example of an electrode assembly having infrared radiation and heating functions.

Figure 9 shows a representation of an example of the device of the invention worn on the head of a person using the device.

Fig. 10 shows an example of stimulation points of the head.

Fig. 11 shows an example of a device comprising an array of electrodes, LEDs and a heating element, and an additional speaker.

Fig. 12 shows an example of a device having a shape that can be wrapped around a neck.

Fig. 13 shows other examples of device modes that may be used.

Fig. 14 shows an example of a device style that may be attached to the head.

Figure 15 shows a version of the device with a helmet-like design.

Fig. 16 shows another example of a helmet-type device.

Fig. 17 shows a version of the device with the stimulation output mounted on a sled.

Fig. 18 shows an exemplary form of an apparatus for improving eye health.

Figure 19 shows the skin-contacting surface of a device for improving eye health.

Fig. 20 shows an example form of a device in the form of a wearable garment with multiple LED lights.

Fig. 21 shows an example form of a vest-style wearable device with multiple LED lights and an additional speaker or vibrator.

Fig. 22 shows an example form of a vest-shaped wearable device and a pants-shaped wearable device with an additional extension at the bottom.

Fig. 23 shows an exemplary device for stimulating a lymph node area.

Fig. 24 shows an example of a pluggable device.

FIG. 25 shows an insertable device for treating hemorrhoids.

FIG. 26 shows a device for treating hemorrhoids in the form of a chair seat.

Detailed Description

In some embodiments, the frequency of the electrical pulses used by the methods and devices of the present invention is preferably (but not limited to) a combination of frequencies between 2-100Hz or in the range of 2-100 Hz; the preferred pulse width is 0.001-50ms and the preferred current is 0.5-100 milliamps. In some embodiments, exemplary preferred electrical pulse repetition rates are about 2 pulses per second and a pulse width of 600 microseconds, or about 15 pulses per second and a pulse width of 300 microseconds, or about 40 pulses per second (e.g., 30-50 or 35-45 pulses) a pulse width of 200 microseconds, or about 100 pulses per second, a pulse width of 200 microseconds, or a combination of the above waveforms to provide effective results. Preferred electrical power levels may be about 0.5-50 milliamps pulse peak height or other power levels that are desirable for a subject to feel comfortable. These non-invasive stimulation devices may also use a wider range of pulse patterns. Bidirectional electrical pulses are preferred to avoid skin damage. Generally, stimulation for 10-60 minutes per day or on demand can provide effective treatment for a person in need thereof.

In other examples, intermediate frequency currents are used. Typical intermediate frequencies (e.g., 1k-10 kHz) can stimulate muscles and provide a massage-like sensation to the treatment area. In order to intervene in the depolarization of the current, a rhythmic increase and decrease of the amplitude (amplitude modulation) can be applied. The Amplitude Modulation Frequency (AMF) determines the frequency of depolarization. The AMF corresponds to the frequency used in low frequency electrotherapy. The amplitude modulation may also be replaced by pulse width modulation.

Modulation of the current pattern used in intermediate frequency electrotherapy can be used in the apparatus of the present invention. Suitable frequencies may be 2k-10kHz. A combination of low and medium frequencies may be used, such as a combination of low frequency current of 1-50Hz and medium frequency current of 2k-10kHz. The low and/or medium frequency may have a variety of waveforms/patterns (e.g., sinusoidal, square, continuous, interrupted, variable, symmetrical or asymmetrical, etc.). The amplitude of the intermediate frequency may vary in the low frequency mode. In some embodiments, a suitable current is between 0.05-5 mA.

Gamma waves (gamma) are a mode of human neural oscillation with a frequency between 25 and 100 hertz, typically 40 hertz. It can improve brain function. The present invention may employ optical, acoustic, vibrational, electrical frequency, electromagnetic or magnetic stimulation capable of stimulating gamma waves in the brain, for example between 25-100Hz, preferably between 30-80 Hz. Stimulation with a frequency may induce the brain to resonate at a similar frequency. In some embodiments, the stimulation frequency, such as an electrical or optical pulse or acoustic pulse or other mechanical (e.g., vibration) frequency, is between 30-60 Hz. In some embodiments, the stimulation frequency, such as the electrical pulse frequency, is between 35-50 Hz. In some embodiments, the stimulation frequency, such as the electrical pulse frequency, is 40Hz. In some embodiments, the frequency is 40Hz and the peak width is between 0.1-0.6ms, e.g., the electrical pulse is 0.3ms. The peak widths of sound, light and other mechanical stimuli may be different, e.g. 1ms to 10ms. In some embodiments, the stimulation frequency of the electrical pulses, etc., is applied in cyclic batches, with the current starting from low to high in each cyclic batch, then being held constant for a period of time, e.g., 1-10 seconds, and then gradually dropping to the next cyclic batch. For example, as shown in FIG. 1a, a stimulation pulse at about 40Hz starts low to high in about 300 milliseconds, then remains constant for about 800 milliseconds, and then gradually falls to low in about 300 milliseconds until the next cycle batch. There may be a period of intervals (no stimulation pulses) between each cyclic batch, for example 1-10 seconds. Combinations of gamma waves of different frequencies may also be used, for example, frequencies of 35Hz for the first 5 minutes, then 5Hz for 40, then 5Hz for 45, and then back to 40Hz for 10 minutes.

In some embodiments, the gamma wave stimulation is administered using medium frequency stimulation such as current or light or sound or vibration. A typical intermediate frequency (e.g., 1k-10kHz as the carrier frequency) may be used. To deliver gamma wave stimulation, the amplitude may be increased and decreased rhythmically at the gamma wave frequency (amplitude modulation). The Amplitude Modulation Frequency (AMF) determines the frequency of the gamma wave signal. The AMF corresponds to the frequency used in the low frequency signal stimulation used in the treatment. Therefore, stimulation such as current patterns used in modulated intermediate frequency electrotherapy may also be used in the apparatus of the present invention. A suitable carrier frequency may be 2k-10kHz. The amplitude of the intermediate frequency may be varied in a low frequency mode of the gamma wave frequency to produce gamma wave stimulation. Combinations of low and medium frequencies can be used, for example, a combination of a low frequency of 30-100Hz gamma frequency stimulation, such as current stimulation, and a medium frequency of 2k-10kHz, such as current stimulation. The low and/or medium frequency may have a variety of waveforms/patterns (e.g., sinusoidal, square, continuous, interrupted, variable, symmetrical or asymmetrical, etc.). In some examples, a suitable current is between 0.05-5 mA. If other stimuli are used, such as light or sound, the intensity of the use should be tolerable or comfortable for the user. Fig. 1b shows an example pattern of amplitude modulated and frequency modulated waves.

Similarly, a light stimulus may also be administered to a subject in need of the same indication. The light stimulation may be gamma wave stimulation with medium or high frequency light. Typical intermediate frequencies (e.g., carrier frequencies of 1k-10kHz or higher) may be used. To give gamma wave stimulation, the amplitude of the light intensity may be increased and decreased rhythmically at the gamma wave frequency (amplitude modulation). The Amplitude Modulation Frequency (AMF) determines the frequency of the gamma wave. The AMF corresponds to the frequency used in low frequency light stimulation. Thus, modulating the light pattern in a medium frequency flash (blinking) can be used in the apparatus of the present invention. Suitable carrier frequencies may be 2k-10kHz or higher, e.g., 10k-1MHz. In some embodiments, the carrier frequency is between 2k-10kHz. The amplitude of the medium frequency may be varied in a low frequency mode of the gamma wave frequency to produce gamma wave stimulation. A combination of low and medium frequencies may be used, such as a combination of low frequency light flashes at a gamma wave frequency of 30-100Hz (e.g., 40 Hz) and medium frequency light flashes at 2k-10kHz. The low and/or medium frequency may have a variety of waveforms/patterns (e.g., sinusoidal, square, continuous, interrupted, variable, symmetrical or asymmetrical, etc.). The amplitude of the intermediate frequency may vary in the low frequency mode. The analog intensity and stimulation duration used should be tolerable or comfortable to the user.

Similarly, sound and/or vibration or other mechanical stimuli may also be administered to subjects of the same indication. Sound/vibration or other mechanical stimulation may be given to gamma wave stimulation using medium or high frequency sound/vibration. Typical intermediate frequencies (e.g., 1k-20 kHz) may be used. To deliver gamma wave stimulation, the amplitude of sound/vibration or other mechanical stimulation intensity (amplitude modulation) may be rhythmically increased and decreased at the gamma wave frequency. The Amplitude Modulation Frequency (AMF) determines the frequency of the gamma wave. The AMF corresponds to the frequency used in low frequency sound/vibration stimulation. Thus, sound/vibration or other mechanical stimulation patterns that modulate the intermediate frequency can be used in the device of the present invention. Suitable frequencies may be 2k-10kHz or higher, for example 10k-100kHz. Lower frequencies, such as 100Hz-1kHz, may also be used. In some embodiments, a suitable carrier frequency may be 0.2k-10kHz. The amplitude of the intermediate frequency may be varied in a low frequency mode of the gamma wave frequency to produce gamma wave stimulation. A combination of low and mid frequencies may be used, for example a combination of low frequencies of 30-100Hz (e.g. 40 Hz) gamma frequency sound/vibration/other mechanical stimulation and mid frequency sound/vibration/other mechanical stimulation of 2k-10kHz. The low and/or medium frequency may have a variety of waveforms/patterns (e.g., sinusoidal, square, continuous, interrupted, variable, symmetrical or asymmetrical, etc.). The amplitude of the intermediate frequency may vary in the low frequency mode. The intensity and duration of the stimulus used should be tolerable or comfortable for the user.

Alternatively, frequency modulated wave (FMF) or PWM (pulse width modulated) stimulation may be used instead of or in combination with Amplitude Modulated Frequency (AMF) to achieve the desired low frequency stimulation (e.g., about 40Hz or delta wave frequency) by using medium carrier frequency (e.g., 1k-10 kHz) or high frequency waves for light or electricity or sound/vibration/other mechanical stimulation or visible or infrared stimulation. PWM (pulse width modulation) is widely used in OLED displays. The present invention can readily employ similar techniques. Fig. 1c shows several pulse width modulation formats. By varying the pulse width at the PWM switching frequency, stimulation at a desired frequency (e.g., about 40Hz gamma frequency or delta wave frequency) can be achieved. For example, a suitable PWM switching frequency may be 1k-10kHz or higher, such as 10k-1M kHz. In some embodiments, a suitable PWM switching frequency may be 10k-100kHz. The low and/or high frequencies may have various waveforms/patterns (e.g., sinusoidal, square, continuous, discontinuous, variable, symmetrical, or asymmetrical, etc.). The amplitude of the PWM frequency may be varied in the low frequency mode. The intensity and duration of the stimulus used should be tolerable or comfortable for the user.

In some embodiments, rather than using gamma wave stimulation, the devices and methods of the present invention use alpha (7.5-14 Hz), or theta (4-7.5 Hz), or delta (about 0.1-4 Hz) wave frequencies/pulse stimulation, or a combination thereof. The stimulus may be selected from electrical pulses, electromagnetic waves, magnetic fields, visible light, infrared, sound/vibration/other mechanical stimuli, or combinations thereof. A stimulus with a particular frequency may induce the brain to resonate at a similar frequency. For inducing brain waves at alpha (7.5-14 Hz) or theta (4-7.5 Hz) or delta (0.5-4 Hz) or zeta (0.1-0.5 Hz), the frequency of stimulation may be alpha (7.5-14 Hz), or theta (4-7.5 Hz), or delta (0.5-4 Hz), or zeta (0.1-0.5 Hz). These patterns and generation of alpha (7.5-14 Hz) or theta (4-7.5 Hz) or delta (0.5-4 Hz) or zeta (0.1-0.5 Hz) stimulation may be similar to those in the previously described gamma wave stimulation, for example the frequencies of alpha (7.5-14 Hz) or theta (4-7.5 Hz) or delta (0.5-4 Hz) or zeta (0.1-0.5 Hz) stimulation may be used directly, or the Amplitude Modulation Frequency (AMF) or FMW (frequency modulated wave) or PWM (pulse width modulation) frequencies or combinations thereof may be used indirectly, similar to the previously described gamma frequencies. Although delta wave frequencies are described in some literature as 0.5-4Hz frequencies, the Zeta (0.1-0.5 Hz) wave frequencies are considered a subset of the delta wave frequencies. The frequency differences between different brain waves are not obvious and are not well defined. For example, some publications define the delta wave frequency as <3Hz, rather than 0.5-4Hz or 0.1-4Hz. In the present invention, the delta wave frequency is defined as a wave having a frequency between 0.1-4Hz.

In embodiments of the invention, the stimulation frequency, such as electrical or optical or acoustic/vibration pulse frequency or other mechanical stimulation (e.g., periodically applying mechanical force/pressure at a particular frequency is considered vibration) is between 0.1-4Hz to induce delta waves. The term mechanical stimulus in the present invention includes acoustic/vibrational stimulus. The sound stimulus is essentially a vibration stimulus. The term vibration in the present invention includes mechanical stimulation, such as applying mechanical force/pressure to a target area periodically at a specific frequency (e.g. pulses). The term vibrator refers to a physical device that can produce vibrations to a target area. Examples of vibrators may be found in devices that provide a massage effect, such as vibrators used in commercial massagers. For example, the vibrator may be a device that provides a kneading effect, such as a finger press. The spinning wheel or inflatable air bladder may be used to apply pressure to the body part to provide a massage effect. The inflatable bladder may be inflated and deflated periodically to provide a cyclic pressure to create a massage effect. In some embodiments, the electrical pulse frequency, the optical pulse frequency, the vibration frequency, and the like, are between 1-3 Hz. In some embodiments, the stimulation frequency, such as electrical pulse frequency, light pulse frequency, vibration frequency, etc., is 2Hz. In some embodiments, the stimulation frequency, such as the electrical pulse frequency, the optical pulse frequency, the vibration frequency, etc., is varied repeatedly between 0.5-4 Hz. In some embodiments, the electrical pulse frequency is 0.3-2Hz and the peak width is between 0.1-10ms, such as 1ms. In some embodiments, the light or vibration pulse frequency is 1-2Hz and the peak width is between 10-400ms, such as 200ms. In some embodiments, the light or vibration pulse frequency is 0.5-1Hz and the peak width is between 100-1000ms, such as 500ms. In some embodiments, the electrical pulse, light pulse, vibration, etc. stimulus is applied in cyclic batches, where in each cyclic batch, the current starts from low to high, for example, then remains constant for a period of time, for example 5-10 seconds, then gradually falls to low for the next cyclic batch, as shown in fig. 1 a. There may be a period of intervals (no electrical or optical or vibration pulses) between each cyclic batch, for example 1-10 seconds. Combinations of different frequencies of the delta wave may also be used, for example a frequency of first 15 minutes 3hz, then 15 minutes 2hz, then 15 minutes 1hz and then 15 minutes 0.5hz back to 1hz for 15 minutes. Combinations of different brain wave stimuli may also be used. In some embodiments, the stimuli are applied in a decreasing frequency sequence, such as an optional gamma (35-45 Hz) wave stimulus for 15 minutes, followed by an alpha 7.5-14 Hz) wave stimulus for 15 minutes, followed by a theta (4-7.5 Hz) wave stimulus for 10 minutes, followed by a delta wave stimulus for 30 minutes.

In some embodiments, medium frequency stimulation, such as electrical current or light or sound or vibration, is used to generate the delta wave stimulation. A typical intermediate frequency (e.g., 1k-10kHz as the carrier frequency) is used. To give the delta wave stimulation, the amplitude may be increased and decreased rhythmically at the delta wave frequency (amplitude modulation). The Amplitude Modulation Frequency (AMF) determines the frequency of the delta wave signal. The AMF corresponds to the frequency used in the low frequency signal stimulation used in the treatment. Therefore, modulation of stimulation, such as current patterns, used in medium frequency electrotherapy can also be used in the apparatus of the present invention. A suitable carrier frequency may be 1k-50kHz. The amplitude of the intermediate frequency may be varied in a low frequency mode of the delta wave frequency to produce the delta wave stimulus. Combinations of low and intermediate frequencies may be used, for example a combination of a low frequency such as current and an intermediate frequency such as current of 2k-10kHz stimulated with a delta frequency of 0.1-4Hz. The low and/or intermediate frequencies may have a variety of waveforms/patterns (e.g., sinusoidal, square, continuous, discontinuous, variable, symmetrical, or asymmetrical, etc.). In some examples, a suitable current is between 0.05-5 mA. If other stimuli are used, such as light or sound, the intensity of the use should be tolerable or comfortable for the user.

Similarly, a subject in need thereof may also be administered a delta wave light stimulus. Light stimulation uses medium or high frequency light to give the delta wave stimulation. Typical intermediate frequencies (e.g., carrier frequencies of 1k-10kHz or higher) may be used. To give the delta wave stimulus, the amplitude of the light intensity may be rhythmically increased and decreased at the delta wave frequency (amplitude modulation). The Amplitude Modulation Frequency (AMF) determines the frequency of the delta wave. The AMF corresponds to the frequency used in low frequency light stimulation. Thus, modulating the light pattern in a medium frequency flash (flicker) can be used in the apparatus of the present invention. Suitable carrier frequencies may be 2k-10kHz or higher, e.g., 10k-1MHz. In some embodiments, a suitable carrier frequency may be 2k-10kHz. The amplitude of the intermediate frequency may be varied in a low frequency mode of the delta wave frequency to produce the delta wave stimulus. The low and/or medium frequency may have a variety of waveforms/patterns (e.g., sinusoidal, square, continuous, interrupted, variable, symmetrical or asymmetrical, etc.). The amplitude of the intermediate frequency may vary in the low frequency mode. The analog intensity and stimulation duration used should be tolerable or comfortable to the user.

Similarly, sound and/or vibration stimuli may also be administered to a subject in need thereof. Sound/vibration stimulation may use low or mid or high frequency sound/vibration to impart delta wave stimulation. Typical low frequencies (e.g., 20Hz-1K Hz) or medium frequencies (e.g., 1K-20 kHz) may be used. To give the delta wave stimulus, the amplitude of the sound/vibration intensity may be rhythmically increased and decreased at the delta wave frequency (amplitude modulation). The Amplitude Modulation Frequency (AMF) determines the frequency of the delta wave. The AMF corresponds to the target frequency used in the sound/vibration stimulation. Thus, the sound/vibration pattern used in the modulated low/medium frequency can be used in the device of the invention. Suitable carrier frequencies may be 2k-10kHz or higher, for example 10k-100kHz. Lower carrier frequencies, such as 20Hz-1kHz, may also be used. In some embodiments, a suitable carrier frequency may be 20Hz-10kHz. A suitable carrier frequency may be 100Hz-1kHz in some embodiments. The amplitude of the carrier frequency may be varied in a low frequency mode of the delta wave frequency to produce the delta wave stimulus. A combination of low and mid frequencies may be used, such as a combination of low frequencies for 0.1-5Hz (e.g., 2 Hz) delta frequency sound/vibration and mid frequencies for 2k-10kHz sound/vibration. The low and/or intermediate frequencies may have a variety of waveforms/modes (e.g., sine waves, square waves, continuous waves, interrupted waves, luffing, symmetric waves, asymmetric waves, etc.). The amplitude of the intermediate frequency may vary in the low frequency mode. The intensity and duration of the stimulus used should be tolerable or comfortable for the user.

Alternatively, PWM (pulse width modulation) or FMW stimulation may also be used instead of or in combination with Amplitude Modulated Frequency (AMF) to use low/medium frequency (e.g. 1Hz-10 kHz) or high frequency for optical or electrical or acoustic/vibrational or visible light or infrared stimulation. PWM (pulse width modulation) is widely used in OLED displays. The present invention can readily employ similar techniques. Stimulation at a desired frequency (e.g., a delta frequency of about 2 Hz) may be achieved by varying the pulse width at a carrier frequency (e.g., a frequency of about 2 khz). For example, a suitable PWM switching frequency may be 1k-10kHz or higher, such as 10k-1M kHz. In some embodiments, a suitable PWM switching frequency may be 10k-100kHz. The low and/or high frequencies may have a variety of waveforms/patterns (e.g., sinusoidal, square, continuous, discontinuous, variable, symmetric, or asymmetric, etc.). The amplitude of the PWM frequency may be varied in the low frequency mode. The intensity and duration of the stimulus used should be tolerable or comfortable for the user.

Humans can detect audio sounds in the frequency range of about 20Hz to 20 kHz. To produce gamma wave sound stimulation, audio sound with a vibration frequency of gamma wave frequency (e.g., 35-50 Hz) may be used directly, as it is in the frequency range audible to the human ear. Alternatively, sound having one or more carrier frequencies other than gamma wave frequencies (e.g., 100Hz to 10 Kz) may be used and gamma wave frequency stimulation provided at gamma frequencies (e.g., 35-50 Hz) by modulating the carrier wave using amplitude modulated waves or pulse width modulated or frequency modulated waves. The carrier sound may be in the form of a single tone/syllable, or a combination of multiple tones/syllables or melodies.

While mechanical stimulation of the skin at a delta frequency, such as vibration stimulation at 0.1-4Hz, is feasible, sounds at delta frequencies (0.1-4 Hz) are not in the human auditory range. To produce a delta-wave audio sound stimulus audible to a human, sound having one or more carrier frequencies in the range of human hearing (e.g., 20Hz to 20 Kz) may be used, and the delta-wave frequency stimulus provided by using a modulated carrier sound wave, by employing an amplitude modulated wave or a pulse width modulated or frequency modulated wave of incremental frequency (e.g., 0.1-4 Hz). The carrier sound may be in the form of a single tone/syllable, or a combination of multiple tones/syllables or melodies.

The current invention discloses devices with means of providing electrical or electromagnetic or magnetic fields or visible light or infrared or sound/vibration or combinations thereof to improve brain and body function. The apparatus includes means for delivering said stimulus at said brain wave frequency. In some embodiments, the apparatus comprises means for generating electrical pulses. The device may also comprise one or more built-in heating means which can maintain the temperature of the skin contact surface between 35-60 degrees to provide a heating effect to the stimulation site/area. The heating means may be an electrical heating element powered by a power source external to the battery. The preferred surface heating temperature is between 40-55 degrees. In some embodiments, the heating temperature of the surface is between 40-50 degrees. Preferred heating elements are self-regulating heaters, such as polymer PTC heating elements or ceramic PTC heaters or carbon fibre/sheet heaters. The resistive heater may be made of a conductive PTC rubber material or a ceramic PTC material, in which the resistivity increases exponentially with increasing temperature. Such heaters generate high power when cold and rapidly heat themselves to a constant temperature. Because the resistivity increases exponentially, the heater will never heat itself to a temperature above the set temperature. The temperature may be chosen during the production of the rubber or ceramic. The heating step may be cycled to avoid skin desensitization. For example, each heating step is 1 to 10 minutes followed by a non-heating period of 0.5 to 3 minutes.

The device may also contain one or more built-in visible and/or infrared radiation elements that can generate visible and/or infrared radiation to produce thermal or non-thermal effects and deliver them to the skin contact surface or area of interest, for example to provide a photonic stimulation and/or heating effect to the stimulation site/area. The visible or infrared radiating elements may be tungsten wire, carbon or alloys of iron, chromium and aluminum, as well as LEDs and lasers or combinations thereof to provide a wider wavelength coverage. Infrared radiating elements are widely used in physical therapy and they can be easily applied to the present invention. The device may have a concentrated visible and/or infrared radiation element coupled to a plurality of optical fibers that transmit visible and/or infrared radiation to the desired stimulation site. The surface of the device housing may have one or more light-transmissive windows to allow photons emitted from the light source to reach the skin suitable infrared wavelengths may be between 700nm and 1 mm. It may be NIR (near infrared) or MIR (mid infrared) or FIR (far infrared) or a combination thereof. In some embodiments, its wavelength is between 800nm-100 μm. In other examples, its wavelength is between 1um-20 μm. The output power of the infrared radiation can be adjusted to provide efficient and safe radiation. When a heating effect is desired, it is desirable to heat the target skin area to a temperature of 40℃ to 50℃ without burning/damaging the skin at a power level acceptable to the user. The radiation may be continuous or pulsed, as used in the electrical pulse stimulation described above. The intensity and duration of the stimulus used should be tolerable or comfortable for the user.

In one example, a 10W infrared radiating element having a wavelength output of 2 μm-10 μm is used; the output is coupled to an infrared fiber to transmit infrared radiation to the treatment site. In another example, an 808nm GaAlAs laser or a 1550nm laser may be used, connected to a plurality of optical fibres to deliver infrared pulses to the stimulation point, and at 10-1000mW/cm ² At a gamma wave frequency (between 30-50 Hz). When the infrared LED is used, each stimulation part can be connected with the infrared LED of the stimulation part without using an optical fiber. The red light and near infrared radiation can penetrate deep tissues, improve the activity of mitochondria and activate the energy metabolism of cells.

In some embodiments, the invention discloses a method for improving brain and other bodily functions in a subject in need thereof, the method comprising administering to a surface of a head region of the subject non-invasive electrical stimulation having a frequency of about 35Hz to about 45Hz and electrical stimulation having a frequency of about 0.1Hz to about 4Hz, such as 0.5-4 Hz. Additional thermal and/or NIR and/or acoustic stimulation may also be applied to the head. Also disclosed is a device having means for generating non-invasive electrical stimulation having a frequency of about 35Hz to about 45Hz and a frequency of about 0.1Hz to about 4Hz, such as 0.5-4Hz, applied to a surface region of a subject's head to improve brain function. The device comprises an electrical stimulation generating source and a fixation device to assist in fixation to the head.

Also disclosed is a method for improving brain function in a subject in need thereof, the method comprising administering to a cephalic region of the subject a non-invasive light stimulus having a frequency of about 0.1Hz to about 5Hz, e.g., 0.5-4 Hz. Additional thermal stimulation may also be applied to the head. The light may be white light, red light or near infrared light. The invention also discloses a device having means for generating non-invasive light stimuli having a frequency of about 0.1Hz to about 5Hz, such as 0.5-4 Hz) for application to a surface region of a subject's head to improve brain function, the device comprising a light stimulus generating source and an anchoring device to aid in anchoring to the head.

The method of improving brain function may also be a combination of electrical stimulation, heat, sound/vibration and visible/infrared (non-thermal effects) as described previously. In general, higher and longer stimulation levels may provide better results, but the stimulation intensity and duration used should be tolerable or comfortable to the user and should not cause damage to the treatment area/tissue and subject. The user can adjust the device output intensity to achieve the desired level. Different types of stimuli may be applied simultaneously or sequentially. For example, electrical stimulation and optical stimulation may be applied to the subject simultaneously, or alternatively or sequentially.

To enhance brain function and cellular activity, the wavelength of light illuminating the head region (non-eye region) may be between 500-1500nm, or 550-1100nm, for example with a peak wavelength of 590nm or 670nm or 780nm or 790nm or 808nm or 810nm or 850nm or 980nm or 1064nm or a combination thereof. In some embodiments, it is selected from red/NIR (near infrared), such as those light waves having peaks at 633, 670, 810, 850, 980, and 1064 nm. In some embodiments, it has a peak wavelength at 808-820nm. In some embodiments, it has a peak wavelength at 633nm or 670nm or 810nm or 850 nm. In some embodiments, the light intensity may be 10-1000mW/cm ² . For example, they may be a plurality of light emitting units, such as LEDs having a power level of 0.5-6W, each with a total power of 5-200W, and the light output of each light emitting unit (e.g., LED) may be 50-600 lumens each. In some embodiments, the irradiation may be from 1 minute to 100 minutes, from 1 to 3 times per day for 1 to 10 weeks or until the desired effect is achieved. The intensity of the light is not too high, otherwise damage to the skin in the illuminated area will occur. The light stimulation may be in a frequency pattern or non-pulsed (continuous) as described previously.

When light irradiation is applied to open eyes or eyelids to improve brain function, the intensity needs to be reduced to such an extent that the user feels comfortable and does not cause damage to the eyes (e.g., 5-100 mW/cm) ² ). When illuminating open eyes or eyelids or nose or ear canal to improve brain function, the wavelength may not be limited to red/NIR, it may be any visible and/or infrared light. The light stimulation may employ the frequency patterns described previously.

Also disclosed is a means and device for improving vision, improving eye health, reducing fatigue, treating dry eye, reducing inflammation of the eye, AMD, and promoting repair of ocular tissue and wounds by providing visible or infrared illumination and heating to the eyelid and/or the ocular region, the device having means for placement on the ocular region. The light stimulus and the thermal stimulus may be applied simultaneously or sequentially. Electrical stimulation may also be applied to the skin at or near the eye, such as at the site of associated acupuncture (e.g., the sun, the eye, the four whites, and the bamboo culm). The device comprises light generating means and heating means, such as the previously described means for head stimulation, and fixation means for placing it in the region of the eyes. Current generating means for providing pulsed electrical stimulation, such as those described previously, may also be and are included.

The wavelengths of the light may be between 550-1100nm, such as those having a peak wavelength at 590nm or 670nm or 780nm or 790nm or 810nm or 850nm or 980nm or 1064nm or a combination thereof. The light irradiation may be direct irradiation with the eyes open or irradiation with the eyes closed through eyelids. The light may have a wavelength of 550-1100nm, for example selected from 590nm, 633nm, 660nm, 670nm, 689nm, 780nm, 790nm, 810nm, 850nm, 980nm,

1064nm, or a combination thereof. If applied to a closed eye, continuous wave white or yellow light is also possible. When white or yellow light passes through the eyelid, it becomes red wavelength rich and other wavelengths are absorbed by the eyelid. When open eye light illumination is applied, in some embodiments, the intensity is 1-10mW/cm at the cornea ² The total dose is 0.1J-50J/cm ² . For each treatment, the radiation may be applied for 5-500 seconds, 1-3 times per day for 1-10 weeks or until the desired effect is achieved. In some embodiments, the intensity is between 20-50mW/cm ² In the meantime. In some embodiments, the intensity is about 40mW/cm ² . During closed eye irradiation, high light intensity irradiation can be used to improve user comfort, and irradiation time can be prolonged to improve user comfort, such as total power density on eyelid of 5-50J/cm ² In the meantime.

The device of the present invention may have a communication module that can communicate with an external control (command) module to receive commands for stimulus output (e.g., stimulus type, time, frequency, on/off, power level, and pulse pattern) and generate corresponding stimuli. The external control module can be a remote controller, and can also be a computer or a mobile phone provided with a special application program. The communication may utilize Wi-Fi or bluetooth or infrared or radio signals. The device may have an on/off control to turn the communication module on or off.

The circuitry of the device may be implemented using well known techniques. There are many designs that can implement a circuit. Fig. 2a depicts an example of a circuit diagram suitable for use in the device. The microprocessor receives input from a keyboard or other input device on the device to set the intensity level of the stimulation, e.g., electrical pulses, and current feedback to adjust the microprocessor output to the voltage converter and current source to produce stimulation pulses at the current level set by the keyboard. The voltage converter converts the battery voltage to a target voltage to drive the stimulation output. The output of the current source is connected to an electrode that contacts the skin. A battery, such as a rechargeable battery pack, provides power to each module.

Similarly, visible/infrared and/or sound/vibration and/or thermal stimulus generating circuitry may also be integrated into the device and controlled by the microprocessor, which is further controlled by a keyboard or remote control device such as a cell phone application. The stimulation tip (e.g., electrodes, speakers, LEDs) may be built into the device body along with other components, or may be separate from the body containing the other components and connected to the body by wires and/or optical fibers to provide better portability and user convenience.

Fig. 2b depicts an example of a circuit diagram of a device with an additional heating element controlled by a microprocessor and a voltage converter. The voltage converter provides two voltages to drive the heating element and the electrodes. Fig. 3 depicts an example of a circuit diagram for a device with electrodes, heating elements, light emitting LEDs and a sound/vibration generating speaker controlled by a microprocessor. An example of a circuit diagram is described in figure 3 of the present inventor's U.S. patent No. 16/819,165.

Figure 4 illustrates one embodiment of a device electrode assembly. On the skin contact surface of the device body, two electrodes are arranged side by side. One electrode serves as the positive pole (or connected to the hot line of a current source) and the other electrode serves as the negative pole (or connected to the neutral line). The outer electrode may also be used to connect to the housing via a connecting means such as a wire to transmit electrical pulses to the outer electrode. If the device comprises a plurality of housings, each housing may comprise only one electrode; the electrodes in some housings serve as positive electrodes while the electrodes in other housings serve as negative electrodes, which may change polarity during stimulation.

Figure 5 shows the skin contact surface of another type of embodiment of the device electrode assembly. A plurality of small electrodes are attached to the skin contact surface of the device body. Some of the electrodes serve as positive electrodes, while others serve as negative electrodes.

Fig. 6 shows an embodiment of a device electrode assembly having a heating element. On the skin contact surface of the device body, two electrodes are attached. Between the two electrodes is a heating element, or heat conducting area (e.g. a metal sheet), under which the heating element is attached. Alternatively, the heating elements or heat transfer areas may be in the form of an array. In a further alternative, the heat conducting areas may also be electrodes.

Fig. 7 shows an embodiment of a device electrode assembly with a light radiating element. On the skin contact surface of the assembly, two electrodes are connected. Between the two electrodes is a transparent window under which a laser or other type of light output source (e.g., LED) is integrated. Alternatively, the transparent windows may be in the form of an array. A laser or LED light source delivers light to these windows through optical fibers. It is also possible to embed a plurality of LEDs on the skin contact surface.

Because multiple stimulation sites are used, some electrode assemblies may serve as negative electrodes and others as positive electrodes, and thus there is no need to integrate different types of electrodes (negative or positive) into one electrode assembly. When connected to the brain region of the head, the electrodes can provide transcranial electrical stimulation, a non-invasive brain stimulation technique that delivers current in the cerebral cortex. Current is applied to the individual's scalp through two or more electrodes, with the current being conducted between the electrodes through the soft tissue and skull, and a portion of the current penetrating the scalp/nearby area and being conducted through the brain. In some embodiments, the transcranial electrical stimulation is gamma wave stimulation and/or delta wave stimulation. The electrodes may be negative or positive or alternately switched. The electrodes may also be connected to other body parts as desired.

Fig. 8 shows an embodiment of the device electrode assembly having a light radiating element and a heating element. The skin contact surface has electrodes, light radiation windows or light emitting diodes, heating elements or heat conducting surfaces, under which the heating elements are placed. The thermally conductive surface may be an electrode surface.

Fig. 9 is a perspective view of an embodiment of the device of the present invention worn on the head of a person using the device. The power supply and pulse generating circuitry of the device may be integrated within a helmet or cap-like shell. Alternatively, the control, power supply and/or pulse generating circuitry may be housed in another housing that is connected to the helmet or cap-like housing by wires. The housing may also be of other shapes and forms, such as a headband, so long as it contains means to secure it to the head or to provide support to place the housing on the head. An external control unit may be connected to the housing in the figure, with stimulation power control buttons and a status display (e.g. LCD or LED display) or touch screen control. The power control button controls the output power level of the electrode. Higher power levels (the intensity of the stimulation current) generally result in stronger stimulation, which may result in better therapeutic results. The person in need uses the control buttons to adjust the power level to achieve the desired therapeutic effect and optimal comfort. These buttons may also be used to control the pulse mode. The LCD display screen displays the operating state of the device, such as the current power level and the pulse mode. The timing function may also be integrated in the LCD.

The power supply and pulse generation circuitry of the device of figure 9 may be integrated in a helmet or cap-like housing 7. Alternatively, the control, power supply and/or pulse generating circuitry may be housed in another housing 8, connected to the housing 7 by wires as shown in figure 9. The housing may also be of other shapes and forms, such as a headband, so long as it contains means to secure it to the head or to provide support to place the housing on the head. An external control unit 8 is connected to the housing in the figure, having stimulation power control buttons and an LCD status display. The power control button controls the output power of the electrode. Higher power levels (the intensity of the stimulation current) generally produce stronger stimulation, which may result in better therapeutic results. The patient adjusts the power level using the control buttons to achieve the desired therapeutic effect and optimal comfort. These buttons may also be used to control the pulse mode. The LCD display screen displays the operating state of the device, such as the current power level and pulse mode. The timing function may also be integrated in the LCD. Four electrode assemblies 2, 3, 4, 5 are arranged on the inner surface of the casing, and respectively contact the skin of shenting, baihui, hind ancient cooking vessel and fengfu acupuncture points. Two external electrode assemblies 1 and 6 (shown in fig. 4) are connected to the housing 7 by wires to take electricity, and are respectively attached to the temple and the signet to provide stimulation. The housing sends electrical pulses to the electrode assembly to apply electrical and/or other stimulation (e.g., light, sound stimulation) to a person in need thereof. Self-adhesive electrodes may be used for the outer electrode assembly. In addition to using wires, a rigid or semi-rigid connection structure including wires may be used to connect the outer electrode assembly with the case.

The apparatus of figure 9 may also include means for providing heat, visible/infrared radiation, mechanical stimulation as previously described to the skin, acupuncture site and/or its vicinity at the top of the skull. The heating/light/infrared stimulation may be applied simultaneously with the electrical stimulation, or alternatively or sequentially. The device may contain sound/vibration generating means, such as one or more speakers/vibrators, which may be attached at a location near the acupuncture site or other head surface area (e.g., scalp or forehead or temple area) or in the form of speakers/earplugs placed in the ears. As previously mentioned, the light/sound/vibration generating means (e.g. LEDs, speakers) may be integrated in the electrode assembly. In some embodiments, the device comprises only sound/vibration and/or heating and/or visible and/or infrared radiation means without any electrical stimulation means, and the therapeutic effect is achieved only by direct heating and/or optical radiation and/or sound.

As shown in fig. 9, a person in need wears the device on the head, attaches electrodes to selected acupuncture points, and electrically stimulates the acupuncture points through the electrodes. Heating and/or light radiation and/or sound/vibration stimulation may also be applied to these sites simultaneously or separately using heat/light/sound/vibration generating means built into the device. The main stimulating acupoints (part shown in fig. 10) can be Baihui, sishencong, fengchi, shenting, benshen, shangxing, fengfu, yintang, taiyang, mute, danyang, tranquilization, shouquan, chengling, naohu, etc. One or more stimulation points may be used. Other auxiliary acupoints can be selected from DAZHUI, NEIGUAN, SANYINJIAO, RENZHONG, SHENMEN, XINSHU, ZHANGYUAN, GUYUAN, YONGQUAN, TAIXI, XUEHAI, BILING, carpal bone, DAZHU, RENYIN, and SHENSHU. The use of the auxiliary acupuncture points in combination with the main stimulation points has higher effectiveness than the use of the main acupuncture points alone. In addition, some of the acupuncture points require additional electrodes or other stimulation generating devices outside the head (e.g., additional electrodes or light or vibration on the wrist are required to stimulate the Neiguan acupuncture points). To stimulate the auxiliary acupuncture points, external electrodes or other stimulation outputs connected to the main housing (e.g., head housing or external power/electronics) can be used to reach these sites. The stimulation of each point/area may be performed simultaneously or sequentially based on a predefined pattern (e.g., cycling from left to right or center to periphery, etc.). As mentioned before, the electrical stimulation may be replaced by heat or light (e.g. red/infrared radiation or sound/vibration) by corresponding means.

Alternatively, the area for stimulation is not limited to the acupuncture site. The subject may be placed on other areas of the head as long as it feels comfortable. In some embodiments, the device as shown in fig. 9 or 11 may have an electrode array or an electrode array with heating/light radiation and/or sound/vibration means overlying the skin on top of the brain with stimulation pulse frequencies between 25-100Hz, preferably between 35-45Hz and/or delta wave frequencies. In some embodiments, the device generates a stimulation pulse frequency at a delta wave (0.1-4 Hz, e.g., 0.5-4Hz, e.g., 1 Hz). In some embodiments, the device generates the stimulation pulse frequency at a delta wave frequency at some point in time and at gamma waves (35-45 Hz) at other points in time. For example, the device used by Novocure may be modified to provide electrical, LED light and vibration stimulation at frequencies of 40Hz and the frequency of the delta waves to improve brain function and treat senile dementia, including alzheimer's disease. The devices disclosed in US patent numbers US8715203 and US7805201 may be modified to produce a frequency with the requirements of the current invention.

In example 1, the device described in fig. 9 or 11 or 13-17 was attached to the head of a volunteer to stimulate the skin at the top of the skull or the skin surface selected from the acupuncture points of the Indian hall, the shenting hall, the Baihui, the Sun and the Sishen or attached to other body parts to stimulate there, and the combined stimulation of electric pulses, pulses of light at 40Hz (e.g., 670nm and 810 nm) was used to improve brain function at an intensity at which the volunteer felt comfortable for about 0.5 hour per day. Optionally, sound/vibration pulse stimulation at gamma wave frequencies (35-50 Hz) is applied at power levels that the volunteer feels comfortable, while using a speaker of the device attached to the ear or skull or other body part. The method and the device can also be used for improving the efficiency in the learning process and the capability of reasoning and solving problems. An apparatus may also integrate external LED lights facing the nostril openings or inserted into the nostrils to provide light stimulation of the same frequency that the user may use in conjunction with light/sound/electrical stimulation of the cranium to improve brain learning and improve learning efficiency. Visible light pulses at gamma wave frequencies (35-50 Hz) from a light source (e.g., LED) may also be applied to the human eye or ambient light simultaneously or sequentially. The device may also have an external LED light and electrodes that can be inserted into the ear canal to provide light/electrical stimulation of the same frequency that the user can use in conjunction with light/electrical/acoustic stimulation of the cranium to improve brain function and improve learning efficiency during learning, and to improve the ability to reason about and solve problems. In another example, the stimulation frequency of the apparatus and method in example 1 is 40Hz.

In one experimental study, a volunteer received electrical pulses from electrodes attached to the apical skin surface at non-acupuncture sites, and applied red/near infrared (630 nm and 850 nm) pulse radiation and vibration stimulation to the apical skin. The intensity at which the volunteers felt comfortable at a frequency and power level of 35-45Hz was 0.5-1 hour per day. The different stimuli need to have the same frequency and the start time points of the 35-45Hz pulses in the different stimuli are aligned to oscillate synchronously. Volunteers had improved sensory memory, sleep quality and cognitive activity.

In another study, volunteers received 40Hz electrical pulses from electrodes, thermal stimulation from heating elements, continuous red/NIR (660 nm and 880 nm) radiation to stimulate acupuncture points selected from the sun, the auditorium, the instinct, the back vertex, the wind fair and the wind pool, and sound stimulation using an in-the-ear speaker with 40Hz pulses at power levels that were comfortable to the volunteers daily, 0.5-1 hour per day, for 2 weeks. The start time points in the 40Hz pulsed electrical stimulation and acoustic stimulation are aligned to synchronize the oscillations. Volunteers have improved sensory memory, sleep quality and cognitive activity.

The apparatus and method of example 2 is similar to that of example 1 except that only gamma frequency (35-50 Hz) is used in example 1 and the sum of gamma and delta frequency stimulation is used in example 2. Gamma wave frequency stimulation As in example 1, the device of example 1 is further provided with means capable of providing a delta wave frequency (0.1-4 Hz, e.g. 0.5-4 Hz) stimulation selected from the group consisting of light/sound/vibration/electrical stimulation. The method of example 1 is further based on the delta wave frequency (0.1-4 Hz, such as 0.5-4 Hz) light/sound/vibration/electric stimulation to improve brain function of the subject, improve learning efficiency during learning, and improve reasoning ability, thinking ability and problem solving ability. Stimulation was performed using gamma wave frequency and delta wave frequency sequentially at different time points each day. For example, gamma wave frequency stimulation may be applied during the day or during pre-sleep/sleep; the delta frequency stimulation is then applied at night or during sleep, for example during slow wave sleep. For example, the device described in fig. 9 or 11 or 13-17 is attached to the head of a volunteer to stimulate acupuncture sites selected from the group consisting of auditorium, shenting, congress, sun and hearing, or to other parts of the body to stimulate the skin surface there, and is used at a combination of electric pulses, light pulses (e.g., 670nm and 810 nm) at a frequency of delta waves for 0.5-2 hours per night or during sleep, such as slow wave sleep, at a power level at which the volunteer feels comfortable, to improve brain function. Visible light pulses at a delta wave frequency (0.1-4 Hz, e.g., 0.5-4 Hz) from a light source (e.g., an LED) may also be applied to the human eye or environment simultaneously or sequentially. It is also possible to simultaneously stimulate sound/vibration pulses at a delta wave frequency (0.1-4 Hz, e.g. 0.5-4 Hz) at a power level at which the volunteer feels comfortable by the administration of a speaker or vibrator device connected to the ear or head. The method and the device can also be used for improving the learning effect in the learning process. The device may also have an external light source (e.g., LED) facing the nasal passage opening or inserted into the nasal passage to provide the same delta wave frequency light stimulation and the user may use it in conjunction with light/sound/electrical stimulation to the head or other body part to improve brain function and improve learning efficiency during learning. The device may also have an external light source (e.g. LED) and electrodes that can be inserted into the ear canal to provide light/electrical stimulation at the same frequency of electrical pulses, light pulses (e.g. visible or red light/NIR, e.g. 670nm and 810nm light), combined with light/electrical/acoustic/vibration stimulation of the skull, improve brain function, improve learning efficiency during learning, improve reasoning, thinking activity and the ability to solve problems. In another embodiment, the device and method employ a stimulating delta wave frequency between 0.1-1 Hz. The device may be a unitary structure providing both gamma and delta wave stimulation, or may include a portion detachable from the body to provide delta wave stimulation. Alternatively, the device is essentially a kit containing two separate components that can be operated independently, e.g., one helmet format (such as those in fig. 15-16) component providing gamma wave stimulation during and another separate component (such as those in fig. 13-14) providing delta wave stimulation.

In example 3, the apparatus and method of examples 1 or 2 are for stimulating the shenting, baihui, sun and wisdom regions. In another example, the stimulation in the apparatus and methods of examples 1 or 2 is applied only to the sun or temporal regions. In another example, the stimulation in the apparatus and method of embodiment 1 or 2 is applied to an area of skin on top of the skull. In another embodiment, the stimulation in the devices and methods of embodiments 1 or 2 is applied to an area of skin on other body parts, such as the wrist, waist, arm, neck, head, face, forehead, hand, foot, finger, toe, palm or sole.

In one experiment, a volunteer received electrical pulses from electrodes attached to the top skin surface of the skull at non-acupuncture sites and applied red/near infrared pulse (630 nm and 850 nm) radiation and vibration stimulation to the top skin of the skull. At a frequency of 0.5-4Hz and a power level at which the volunteer feels comfortable, 0.5-1 hour per day. The different stimuli have the same frequency and the start times of the 0.5-4Hz pulses in the different stimuli are aligned at the same point in time to oscillate synchronously. Volunteers have improved sensory memory, sleep quality and cognitive activity.

In another experiment, the volunteers received 1Hz electrical pulses from the electrodes, thermal stimulation from the heating element, continuous red/NIR (660 nm and 880 nm) radiation to stimulate selected acupuncture points from the auditorium, benne, back roof, wind pool and the wind pool, and audio sound stimulation at a power level at which the volunteers were comfortable in the ears with pulses at a frequency of 1Hz, using a speaker for 0.5-1 hour per day stimulation. The start times of the 1Hz pulses in the electrical and acoustic stimulation are aligned at the same point in time to oscillate synchronously. Volunteers have improved sensory memory, sleep quality and cognitive activity.

In another experiment, the volunteers received 2Hz electrical pulses from the electrodes to the temples, and an additional 2Hz green wavelength and 880nm light and speaker were provided as ambient light/sound stimuli with the audio sounds emitted by the 2Hz pulses, without physical contact with the volunteers. The start times of the 2Hz pulses in the electrical, optical and acoustic stimuli are aligned at the same point in time to oscillate synchronously. Stimulation was performed during sleep at a power level at which volunteers felt comfortable 0.5-1 hour per day. Volunteers had improved sensory memory, sleep quality and cognitive activity.

In another experiment, volunteers received 0.1-1Hz red light and 100Hz sound pulses (pulse frequency 0.4-1 Hz) emitted from a speaker as ambient light/sound stimuli without physical contact with the volunteers. The light and acoustic pulses have the same frequency, between 0.1-1Hz, and the start of the pulses in the light and acoustic stimuli are aligned at the same point in time to oscillate synchronously. Stimulation was given daily during sleep for 1 hour at a stimulation level that did not wake the volunteers. Volunteers had improved sensory memory, sleep quality and cognitive activity.

In example 4, the device including the stimulation output device as described in fig. 11 to 17 was attached to the head of the volunteer to stimulate the skin surface of the head at acupuncture sites or non-acupuncture sites, or attached to other sites of the body to stimulate the skin surface there with electric pulses, red light and/or NIR pulses (e.g., 655nm, 810nm and 850 nm), sound/vibration stimulation at gamma wave frequencies (35-50 hz) and delta wave frequencies (0.1-4 hz) at power levels where the volunteer feels comfortable for 0.5-2 hours per day for 2 weeks to improve brain function (such as memory, sleep quality and cognitive ability) activities), improve learning efficiency and sensory processing ability, improve reasoning, thinking activity and problem solving ability. Stimulation was performed at different time points each day using gamma and delta wave frequencies, respectively. For example, gamma frequency stimulation is applied during the day, and delta frequency stimulation is applied at night or during sleep. In another example, gamma wave frequency stimulation is applied during the night or sleep, while delta wave frequency stimulation is applied during the day or awake state. The stimulus may be applied to a region of the head surface that covers only the frontal lobe or only the parietal lobe or only the occipital lobe or only the temporal lobe or any combination thereof. In another example, the apparatus and method of example 4 further comprises a heating element attached to the head of the volunteer to stimulate acupuncture sites selected from the group consisting of the auditorium, the god, the back vertex, the wind pool, or non-acupuncture sites on the scalp, among other types of stimulation. The device shown in fig. 11 has 18 stimulation outputs (9 on each side of the head), in some embodiments fewer (e.g., 4-10) or more (e.g., 20-30) stimulation outputs may be employed in the device and the foregoing method employed for applying electrical and/or optical and/or acoustic/vibrational stimulation to the head. These stimulation outputs may be spatially arranged uniformly or in a configuration to apply stimulation to a particular area. Furthermore, to improve brain function, the array of stimulation outputs may be embedded in the skin-contacting side of a cap or helmet-type covering that may cover the head to provide red and/or NIR stimulation to the surface of the head. The cap or helmet-mounted cover may have a light reflecting layer to prevent light leakage and direct most of the light towards the skin. The red and/or NIR stimulation frequencies may be gamma (35-45 Hz), alpha (7.5-14 Hz), theta (4-7.5 Hz), delta (0.1-4 Hz) waves at different points in time, such as 10 minutes each. Or continuous non-pulsed stimulation (e.g., 10 minutes). An array of heating elements may also be embedded in a hat or helmet-type covering to provide thermal stimulation to the brain region.

In one experiment, volunteers received electrical pulses from electrodes at a frequency between 35-45Hz to stimulate acupuncture sites of the sun, the auditorium, the god, the back roof, the wind pool, continuous red/near infrared pulses (630 nm and 850 nm) radiating the skin at the top of the skull, and acoustic stimulation of audio pulses transmitted from a speaker to the ear at a frequency between 35-45Hz during the day for 0.5-1 hour at the volunteer felt comfortable power level. The different pulsed stimuli have the same frequency and the start of the 35-45Hz pulses in the electrical and acoustic stimuli are aligned at the same point in time to oscillate synchronously. The volunteers also received 1-2Hz electrical pulses from the electrodes to the temples, with additional 1-2Hz light at green wavelength and 200Hz audio sounds emitted by the speaker at 1-2Hz pulses as ambient light/sound stimuli, providing stimuli without physical contact with the volunteers for 1-2 hours each day during sleep. Different stimuli have the same frequency and the pulse start times in the electrical, optical and acoustic stimuli are aligned at the same point in time to oscillate synchronously. The volunteers experienced improved sensory memory, sleep quality and cognitive activity, which was more pronounced than the use of stimuli during the day alone or during sleep alone.

Devices having a configuration/shape similar to that of fig. 9 or in examples 1-4, including a means of providing heat to the head, particularly the top and back of the head (e.g., using a heating element or thermal infrared radiation), can also be used to improve brain function and/or reduce symptoms of dementia by improving blood flow in the brain. Higher temperatures (heating) in the brain region can promote blood flow, thereby improving brain function and/or reducing the symptoms of dementia. The device is essentially a hat or helmet with a built-in heating means that covers most of the area of the top and/or back of the head, not limited to the acupuncture points described above. It may have a thermal insulation layer to maintain high temperature (e.g., 40-60 degrees) in the covered area. The heating may be constant or intermittent (e.g., alternating the heating off for 30 seconds for one minute). A person in need thereof may wear it to heat their brain area to improve brain function and/or reduce symptoms of dementia (e.g., 3 times a day, 0.5 hours each). The heating stimulus may be applied simultaneously with the other stimuli, or alternatively or sequentially. In some embodiments, the device comprises only heating means and optical radiation stimulation means at gamma and delta wave frequencies, and the therapeutic effect is achieved by heating and/or optical radiation. The device may also have an attachment, built-in heating and/or light stimulation means, which may wrap around the neck of a person in need thereof, heat the blood vessels of their neck to promote blood flow, and provide red/infrared radiation, which may be essentially a neckerchief/scarf with built-in heating/light stimulation means. Another form of device is one that wraps only around the neck of a person without being attached to a cap/helmet-like form. Fig. 12 shows an exemplary form of the device, which is shaped to wrap around the neck. The left side of figure 12 shows a version of the device with an extension on the back, which may reach or be close to the lower end of the occipital region, containing a heating element and/or red/NIR stimulation means (e.g. 670nm and 810nm LEDs) for applying thermal and/or optical stimulation to the carotid artery and jugular vein regions, and optionally electrodes for applying electrical pulses to the windpool and/or the Fengfu and/or the Pepper's acupoint region and/or the carotid sinus region. It can also be used to reduce blood pressure by applying heat (e.g., 40-60℃), light and/or electrical stimulation to the neck for 5-20 minutes or until the desired effect is achieved using the device. A method of improving brain function and/or alleviating the symptoms of dementia by increasing cerebral blood flow and activating mitochondrial activity of blood cells by applying heat and light irradiation (continuous or gamma wave frequency and/or delta wave frequency) to the neck and/or head region of a person in need thereof is disclosed.

Vibration/sound stimulation with optional frequencies of gamma (35-45 Hz), alpha (7.5-14 Hz), theta (4-7.5 Hz), delta (0.1-4 Hz), or combinations thereof can be applied to subjects with the above-mentioned need for improved brain function, and corresponding devices (e.g., speakers, motors, vibrators) can also be placed in the devices as shown in examples 1-4 and FIGS. 9-26. The sound and vibration may also mimic the snoring of a cat, which is typically between 20Hz and 150 Hz. The housing may also be a pillow-type shape, on which the user may lie and put his head to receive said vibration and/or sound stimuli. In some embodiments, the pillow device produces a vibration/sound stimulus. In some embodiments, the pillow device generates a vibration/sound stimulus as well as a heating stimulus and a cooling stimulus. In some embodiments, the pillow device produces vibration/sound stimulation and light stimulation and optionally thermal stimulation.

In some embodiments, the electrical and/or acoustic/vibratory or light pulses are selected from gamma waves (35-45 Hz), alpha waves (7.5-14 Hz), theta waves (4-7.5 Hz), delta waves (0.1-4 Hz), or combinations thereof, suitable for use in locations other than the head, such as the wrist, waist, legs, feet, arms, palm, and fingers. The frequency may be an apparent frequency (unmodulated) or an FMF frequency or an AMF frequency or a PWM frequency. The device may be a wrist band or watch type device or a hand held device with skin contacting electrodes on the housing, such as those described in patent application US20040102819 and chinese patent CN 2676947Y. It may also have a configuration that can be held in the palm of a hand, for example an egg shape, so that a stimulus can be applied to the palm of the hand. An example of a device configuration that may be used is shown in fig. 13. Fig. 13c and d show a device that can be held by hand with small circular or band-shaped electrodes on the surface to stimulate the palm. Additional sound/vibration and/or heating/cooling stimuli may also be provided by the handheld device with corresponding means incorporated therein. For example, red/near infrared LEDs may be embedded in the surface of the handheld device and a speaker/vibrator may be placed inside the device. The handheld device may be configured to emit gamma wave stimulation while the user is awake or delta wave stimulation while the user is asleep to improve brain function. In one example, a user holds the handheld device while he is awake to receive 40Hz electrical pulses to his palm and 40Hz vibration stimulation and 40Hz red light stimulate his palm for 0.5-1 hour per day, with the start times of the 40Hz pulses in the different stimulations aligned at the same point in time to oscillate synchronously; the user also holds the handheld device before sleeping and while asleep and receives 0.5-1Hz electrical pulses to his palm and 0.5-1Hz vibration stimulation and 0.5-1Hz audio sound stimulation to his palm, 1-3 hours per day, different types of stimulation having the same frequency and 0.5-1Hz pulses in different stimuli starting at the same point in time aligned to oscillate synchronously; so as to improve the brain function of the user and improve the sleep quality. Fig. 13g shows a belt-shaped device that can provide stimulation to the waist or abdominal area. The user may use these devices 1-3 times a day for 10-30 minutes to improve brain function. Users can also use them during learning to improve learning, for example, by applying 35-45Hz gamma wave stimulation (electrical or electrical + sound/vibration) at learning time to improve sensory processing and learning efficiency, improve reasoning, thinking activity, and the ability to solve problems. Multiple different types of devices can be used simultaneously to stimulate multiple areas of the body for better results, where the stimulation pulses need to be synchronized so they use the same frequency and the start of the pulses in different stimulations are aligned with the same time to oscillate synchronously.

As noted, the devices described in this invention for generating gamma wave stimuli (e.g., electrical pulses, visible/NIR, sound/vibration) including gamma wave stimuli can also be combined to generate stimulation devices having wave frequencies selected from alpha (7.5-14 Hz), theta (4-7.5 Hz) and delta (0.1-4 Hz) waves or combinations thereof. Thus, the method of improving brain function and treating senile dementia, including Alzheimer's disease, further comprises administering to a subject in need thereof a combination of gamma wave stimulation and stimulation selected from alpha wave (7.5-14 Hz), theta wave (4-7.5 Hz), delta wave (0.1 Hz-4Hz, such as 0.5-4 Hz). In some embodiments, the methods of improving brain function and treating senile dementia, including alzheimer's disease, further comprise administering to a subject in need thereof a combined stimulation with a frequency of gamma and delta waves (0.1-4 Hz, e.g., 1-2 Hz). The stimulus may be electrical pulses, light, NIR, sound/vibration and combinations thereof. In one example, a human head is stimulated with electrical stimulation at gamma wave frequencies (35-45 Hz) for 30-60 minutes followed by alpha wave frequencies or theta wave frequencies or delta wave frequencies, or alpha followed by theta wave frequencies for 30-60 minutes of pre-sleep stimulation, and 30 minutes in sleep at delta wave frequencies (0.1-4 Hz, e.g., 1-2 Hz) several times.

Devices suitable for use in the present invention may take many different forms, configurations and shapes, for example in the form of a hat or hair band or glasses or helmet or self-adhesive patch. Fig. 14-17 show some exemplary formats/configurations that may be appended to the header. Their skin-facing portion/skin contact surface may comprise one or more electrodes that may be used to apply electrical pulses to a subject in need thereof. It may also include a speaker or motor (vibrator) to provide sound/vibration stimulation as well as light/NIR output (e.g., LED) and/or heating elements. They may have means to communicate with and be controlled by a remote control device, such as a cell phone, with bluetooth or Wi-Fi or other radio frequency signals. A cell phone application may be used to control the device.

As shown in fig. 14a, the electrodes in the head-mounted device are attached to the head, and provide electrical stimulation with gamma (35-45 Hz) and delta (0.1-4 Hz) frequencies to improve brain function, and can also be used to improve learning ability, reasoning, thinking activity and problem solving ability during learning. Fig. 14b shows another version where stimulation outputs such as electrodes, light and sound/vibration stimulation devices are located on the skin contact side of the device and are applied to the forehead using self-adhesive. Figure 14c shows another form in which the stimulation output is connected to the skin contact side of the device. FIG. 14d shows another form in which the LEDs and electrodes of the device are connected to the temple regions; another LED and speaker/vibrator is mounted on the forehead area.

Figure 14e shows another form of spectacle frame similar to that without the lens area, where one or more electrodes are located on the skin contact side of the device. The device may be applied to the forehead and the speaker mounted near the ear area, attached to the head in a manner similar to that in fig. 14d or similar to that of wearing glasses. The device comprises a built-in electronic device which can generate 30-50Hz electric pulse stimulation and 30-50Hz audio sound pulse stimulation for a user; it can also generate electrical pulse stimulation of 0.1-2Hz and audio sound pulse stimulation of 0.1-2Hz for the user at different times. The device can communicate with a cell phone, which can control the device to adjust its stimulation frequency, intensity and operation time. FIG. 14f is a device similar to FIG. 14e with an LED attached facing the eye to provide optical stimulation to the eye at gamma or delta wave frequencies. The light may be white or colored light, such as yellow or green or red or NIR or a combination thereof. Fig. 14g is a device similar to fig. 14f except that it is in the shape of a pair of glasses, two LEDs are placed in the area in front of the eyes to provide light illumination, and two or more external electrodes are connected to the device body through cords to provide stimulation to more skin areas. It may also be in the shape of an eyecup similar to 18 and 19.

Figures 15 and 16 show a helmet-like form of device with means for providing stimulation to the head region. Portions 14 and 15 of the device have a light source (e.g., LED) and electrodes on their skin-contacting side to provide electrical pulses and red and/or NIR (e.g., 670nm and 810nm,20-200 mW/cm) to the skin area ² ) The light pulses stimulate the skin area overlying the parietal and occipital lobes. Part 16 of it has LEDs and electrodes to provide electrical and red/NIR light pulse stimulation to the skin area overlying the occipital lobe and wind pool, fengfu acupoints. Portions 11, 13 thereof have LEDs, electrodes and optional speakers/vibrators that provide electrical, optical and sound/vibration stimulation to the skin area in the frontal lobe and temple areas. The frequency of stimulation is selected from gamma waves (35-45 Hz), alpha waves (7.5-14 Hz), theta waves (4-7.5 Hz), delta waves (0.1-4 Hz), or combinations thereof. Part 12 of which contains a light source, such as an LED, that provides light stimulation to the eye (either through an eyelid-closed eye or an open eye) at gamma or delta frequencies for different periods of time; wherein the light may be red or NIR or white light or yellow or green light or a combination thereof. Additional heating/cooling elements and optional speakers/vibrators may also be incorporated in the components 11-16 to provide heating or cooling stimuli continuously or intermittently. A pair of earplugs are connected to the portion 13 to provide gamma or delta wave sound pulse stimulation to the user. The helmet is made up of two parts, the part containing 11-13 can be pushed closer or moved away from the part containing 14-16 to accommodate users of different head sizes. As shown in fig. 16, the knob and sled are used to adjust the device to fit the user's head. Vibrators such as air bladders may be placed on the skin contacting side of fig. 16 to provide a massage effect, such as massage stimulation at a delta wave frequency.

Fig. 17 shows another device form, a plurality of stimulation output units 21 are mounted on a slide rail 23 to allow the user to change the stimulation site. The stimulation output unit 21 is provided with light emitting diodes and electrodes to provide gamma (35-45 Hz) or delta (0.1-4 Hz) frequency stimulation. The speaker or vibrator 22 may provide gamma (35-45 Hz) or delta (0.1-4 Hz) frequency stimulation to the area near the ear. Additional LEDs that can provide light stimulation to the nose may also be included. Fig. 17c shows two stimulation output units 21 which may be mounted on the head by means of a slide rail 23 to provide thermal and near-infrared light stimulation to the area below.

Fig. 18 shows another type of device in the form of an eye mask covering the eyes and nearby areas to provide thermal and continuous or pulsed light stimulation to improve brain function and eye health. The light may be white or yellow or green or red or NIR or combinations thereof at gamma (35-45 Hz), alpha (7.5-14 Hz), theta (4-7.5 Hz), delta (0.1-4 Hz) frequencies or combinations thereof. The light intensity needs to be comfortable for the user. In one example shown in fig. 19a, the device of fig. 19a has a plurality of heating elements 31 built into it, two LEDs under the eye-facing region 32, and an elastic headband 33 for placing it on the head. The eye-facing surface 32 has a number of small holes to allow light from the underlying LED to pass through to the eye. It may also be a transparent window through which light passes, or a small aperture with a diverging lens through which light passes to illuminate a larger area. Optional electrodes may also be incorporated into the device to stimulate the area around the eye. As shown in fig. 19b, two or more external electrodes may be connected to the device body with a cord to provide stimulation to the skin.

The devices of fig. 18 and 19 may be used to improve vision, treat dry eye, reduce ocular inflammation, AMD and improve repair of ocular tissues and wounds by providing visible or infrared light illumination to the eyelids (which may close the eye) and/or the ocular region, as well as providing heat and optional electrical pulse stimulation to stimulate the ocular region as previously described. The light illumination may be white light or red light or NIR or a combination thereof. The light stimulation may be at a pulse rate to improve brain function, may be performed continuously without pulses, or may be performed intermittently (e.g., on for 2 minutes and off for 1 minute). For example, the light source may be a white LED or 780nm LED to provide 10-50mW/cm at the cornea ² Illumination of (2). Phototherapy may be performed 1-3 times a day for 2-20 minutes each time. The heat treatment may be performed as frequently as necessary. Can be applied simultaneouslyLight and heat stimulation. The white light stimulus is suitable for illuminating eyelid closed eye stimulus.

The device shown in fig. 19 is an exemplary device for improving vision, treating dry eye, reducing eye inflammation, AMD, and improving tissue and wound repair of an eye by providing red and/or NIR light illumination to the eyelid (which may be an occluded eye) and/or to the ocular region, and may also provide heating and/or cooling stimuli to the ocular region, and optionally electrical pulses to stimulate the ocular region or acupuncture sites (such as the bamboo cul-de-sac, sun, tetra-white, qing, zaar, and yu-zi instruments) that may improve ocular health, as previously described. The light illumination may be red light or NIR or a combination thereof. It has a USB interface for connecting a power source, such as a portable rechargeable battery pack, to power the circuitry, heating device and LEDs. It has a control interface to adjust the stimulation pattern, intensity and time. Fig. 19b shows the side facing the eye. It has a headband-like strap that can be secured to the eye area. It has a soft fabric covered raised area 1 containing a heating element to provide a 40-60 degree heating stimulus and a depressed area 2 containing one or more 630nm red LEDs and one or more 850nm NIR LEDs, facing the eye, to provide light illumination. Additional massaging devices, such as vibrators (e.g., airbags), may also be included. red/Near Infrared (NIR) light activates mitochondrial function, increases ATP production and has deep tissue penetration (up to several centimeters). They can improve cellular energy metabolism and improve/restore cell viability. They can promote tissue, nerve growth and repair in wound healing. Irradiation of the fundus with NIR or red light may improve vision by increasing photoreceptor sensitivity, which decreases after age 40, and may treat AMD in human subjects. Hot compress on the eyes can relieve dry eye and eye fatigue. In one example, a volunteer using a device such as the model b of fig. 19, heat stimulated an area of the eye at 40-60 degrees and red/NIR (670 nm and 810 nm) stimulation of the closed eye 3 times a day over a week felt the eye vision improved and eye fatigue and dry eye symptoms alleviated.

The brain function improving apparatus of the present invention may further include electroencephalogram (EEG) sensors (electrodes) to detect brain waves of a subject and accordingly give a stimulus to induce desired brain waves in the subject. Different people may have different brain wave frequencies, their brain wave frequencies (e.g., their gamma and delta wave frequencies) may be measured and the device may use these particular brain wave frequencies for stimulation. For example, if a person's gamma wave frequency is normally about 50 hertz, a 50 hertz electrical or optical or acoustic stimulus may be applied to the person to improve his brain function. When the target brain wave frequency is significantly different from the current brain wave frequency, the device may gradually change the stimulation frequency toward the target frequency until the desired brain wave frequency is reached. For example, if the target brain wave frequency is a delta wave (e.g., 0.5-4 Hz) and the currently measured brain wave frequency is a beta wave (12-38 Hz), the device may apply stimulation at the alpha wave frequency (7.5-12 Hz) to the brain until the measured brain wave is an alpha wave, then apply stimulation at the theta wave frequency (4-7.5 Hz) to the user until the measured brain wave is a theta wave, then apply stimulation at the delta wave frequency (0.5-4 Hz) to the user until the measured brain wave is a delta wave, and then maintain the delta wave stimulation for a certain time. In each stimulus, the frequency may also be gradually varied toward a target frequency, such as an alpha wave at 12Hz for the currently measured brain waves of the user, and a delta wave at 2Hz for the desired target, i.e., the stimulus may be applied gradually from 12Hz to 7.5Hz, then gradually to 4Hz, and then gradually to 2Hz. In some embodiments, when applying delta wave (0.5-4 Hz) stimulation during slow wave sleep, the device may monitor the user's brain waves and apply delta wave stimulation or apply stimulation gradually from the currently measured brain wave frequency stimulation (e.g., theta wave) to delta wave frequency stimulation once in the slow wave sleep mode. The device may monitor the sleep time of the user and apply the stimulus accordingly. In some embodiments, the device applies gamma wave frequency stimulation during rapid eye movement sleep of the user to improve brain function.

In some embodiments, both gamma and delta wave stimulation may be applied while the user is awake. In some embodiments, gamma and delta wave stimulation may be applied while the user is in a sleep state. In some embodiments, gamma wave stimulation is applied when the user is awake, and delta wave stimulation is applied when the user is asleep. When a stimulus is applied to a sleeping user, the stimulus should preferably not wake up the user. This may be done by adjusting the intensity to a lower level and/or gradually slowly increasing and decreasing the intensity while the stimulation pulse is applied.

Also disclosed are methods of improving body function, enhancing immunity, promoting metabolism, improving skin condition, treating skin disorders, resisting aging, increasing mitochondrial activity in human cells, reducing weight, controlling weight, burning fat, increasing cell viability and improving tissue regeneration by applying red and/or NIR light stimulation and optionally heat to a specific area or a substantial portion of the body's skin surface. red/Near Infrared (NIR) light activates mitochondrial function, increases ATP production and has deep tissue penetration (up to several centimeters). They can improve cellular energy metabolism and improve/restore cell viability. They can promote tissue, nerve growth and repair in wound healing. Its effect of improving blood and lymph circulation would also provide beneficial health effects. In some embodiments, the device may have the shape/structure/size of a blanket/comforter or sleeping bag or of the type of full body garment that can cover a large portion of the human body or in the form of a partial garment that can cover the torso of the body. The device comprises a flexible fabric sheet or membrane. The skin-contacting side of the device has an array of light emitting units, such as LEDs or light bulbs or lasers. The wavelength of the light may be between 550-1100nm, such as those having a peak wavelength at 590nm or 670nm or 780nm or 790nm or 808nm or 810nm or 850nm or 980nm or 1064nm, or combinations thereof. In some embodiments, it is selected from red/NIR, such as those having peaks at 633, 670, 810, 850, 980, and 1064 nm. In some embodiments, it has a peak wavelength at 808-820 nm. In some embodiments, it has a peak wavelength at 633nm or 670nm or 810nm or 850 nm. In some embodiments, the light emitting unit is a 670nm LED or a 810nm LED or a 850nm LED or a combination thereof. In some embodiments, the light intensity may be 0.1-100mW/cm, measured at the skin when it is placed on the human body ² . For example, the device may have a plurality of light emitting units, e.g. 10-100 spatially uniformly distributed LEDs, each havingThere is a power class of 0.1-6W, the total power is 5-200W, and the light output of each lighting unit (e.g. LED) may be 10-500 lumen. The light intensity and power level needs to be comfortable for the user. Excessive light intensity and power levels that may damage the irradiated skin/tissue should be avoided. The device may have a controller that can adjust the treatment time and intensity. The device may have a light reflecting layer (e.g. an aluminum coating) facing the light emitting unit and the skin to prevent light leakage to the outside and to keep most of the light towards the skin. The device may also have ventilation means, such as an air inlet connected to a fan, to direct an air flow into the covered body space to avoid overheating. It may be powered by batteries or a low voltage converter (e.g., 5V-36V) connected to a 110V-220V power outlet. To achieve the desired effect, the user may cover a specific area or a large part of the body with the device to receive red light

NIR radiation from 5 minutes to 1 hour, 1-3 times per day, naked or through-the-light clothing, similar to indoor tanning but using red/near infrared instead of UV. In some embodiments, the device has a flexible structure of neckerchief/scarf or a rigid structure similar to the device in fig. 12 to wrap around the neck to provide red/NIR light to the neck region to illuminate the arterial and jugular venous regions, particularly the carotid artery, to achieve these effects, rather than a full body coverage. Irradiation may be continuous or intermittent (e.g., 2 minutes on and 1 minute off). The pulse light irradiation may be performed at the electroencephalogram frequency. In some embodiments, the irradiation may be from 1 minute to 100 minutes, from 1 to 3 times per day for 1 to 10 weeks or until the desired effect is achieved. The intensity of the light is not too high, otherwise damage to the skin in the illuminated area will occur. The light stimulation may be in a frequency pattern (e.g., brain waves) or non-pulsed (continuous) as described previously. Additional devices that can provide sound or vibration stimulation may also be incorporated, such as gamma (35-45 Hz), alpha (7.5-14 Hz), theta (4-7.5 Hz), delta (0.1-4 Hz) stimulation, or combinations thereof, as previously described. In some embodiments, a speaker or vibrator or inflatable bladder provides sound or vibration or other mechanical stimulation at a frequency selected from between 0.1Hz and 10 Hz. In some embodiments, the speaker or vibrator or inflatable bladder provides sound or vibration or other mechanical stimulation at a frequency selected from between 10Hz and 50 Hz. In some embodiments, a speaker or vibrator or inflatable bladder provides sound or vibration or other mechanical stimulation at a frequency selected from between 20Hz and 150 Hz. In some embodiments, a speaker or vibrator or inflatable bladder provides sound or vibration or other mechanical stimulation at a frequency selected from between 100Hz and 200 Hz. In some embodiments, a speaker or vibrator or inflatable bladder provides sound or vibration or other mechanical stimulation at a frequency selected from between 200Hz and 500 Hz. In some embodiments, a speaker or vibrator or inflatable bladder provides sound or vibration or other mechanical stimulation at a frequency selected from between 500Hz and 600 Hz. In some embodiments, the speaker produces or simulates a cat snore sound. In some embodiments, it further comprises heating means, such as those previously described, to provide thermal stimulation to the body through the skin contact surface between 40-60 ℃. In some embodiments, the apparatus further comprises electrical pulse stimulation means, such as those previously described, to provide electrical pulse stimulation to the body. In some embodiments, it further comprises an electrical and/or magnetic field stimulus generating means for providing electrical/magnetic field stimuli to the body. Light or sound or vibration or heat or electric/magnetic field stimulation may be applied to selected specific areas, such as the acupuncture points or their nearby areas or the area covering the lymph nodes or the area covering specific organs or all areas that the fabric may cover, such as the whole body or torso, etc.

The device may have control means, such as a built-in circuit with control buttons/surfaces, which may adjust the treatment time and intensity as described above. The device may have a communication module that may communicate with an external control (command) module to receive commands for stimulus output (e.g., stimulus type, time, frequency, on/off, power level, and pulse pattern) and generate stimuli accordingly. The external control module can be a remote controller, and can also be a computer or a mobile phone provided with a special application program. The communication may utilize Wi-Fi or bluetooth or infrared or radio signals. The device may have an on/off control to turn the communication module on or off. The device may have a built-in power source, such as a battery or be connected to a power outlet.

In some embodiments, the device is in the form of a wearable garment, such as a vest, sleeveless upper body shirt, skirt, shorts, short sleeves, etc., as shown at the top of fig. 20. In some embodiments it has a hat/hood and/or a tall-neck shaped component so it can provide stimulation to the neck and head area as shown. As shown at the bottom of fig. 20, one exemplary device is a wearable device like a vest, with a plurality of LED lights fixed inside to face the skin. LEDs may also be placed on the outer surface of the fabric if the fabric is transparent to red/NIR or does not significantly block light. If it blocks the passage of light, it is necessary to place the LED on the inner surface of the fabric. The vest may have a plurality of pockets for holding the electronic components of the device, such as the control unit and power supply. In one example, the LEDs used in the vest in FIG. 20 are 650-670nm red LEDs at 0.2W each and 850nm NIR LEDs at 0.1W each. One volunteer used it 0.5-1 hour a day for one month, and reported a decrease in body fat, an improvement in skin condition, an enhancement in immunity, an increase in energy level, and an improvement in sleep quality.

As shown in fig. 21, one or more speakers or vibrators are placed on the vest to provide the sound/vibration stimulation. In one example, the LEDs used in the vest of FIG. 21 are 650-670nm red LEDs at 0.2W each and 850nm NIR LEDs at 0.1W each. The built-in speaker produces gamma wave sound (40-50 Hz) or Delta wave sound pulses modulated at 0.2-2 Hz. One volunteer used it 0.5-1 hour a day for one month, and reported a decrease in body fat, an improvement in skin condition, an enhancement in immunity, an increase in energy level, an improvement in sleep quality, and an enhancement in memory.

As shown in fig. 22, additional extensions are added to the bottom of the vest, which will provide stimulation to the lower abdomen, lower back, anal region (which can treat hemorrhoids and other digestive diseases such as constipation), pubic region, and genital region. These areas may also be stimulated by means of a device in the form of a panty as shown on the right in fig. 22. It can further be used to improve the production of sex hormones, thereby improving muscle growth and providing anti-aging effects. It can also improve female gynecological health. It may also be in the form of a waist/crotch cloth shaped in place of shorts, or in the form of a sanitary belt or diaper/diaper pants or pad, which may provide light stimulation with LEDs and optionally heat stimulation and other stimulation, such as sound/vibration stimulation of the anal, pubic and genital areas. It can be used to alleviate discomfort or improve the health of these areas or systematically improve health.

Also disclosed is a method of enhancing immunity by applying the red/NIR stimulation and optionally the heat stimulation to an area of skin selected from the group consisting of major lymph nodes, adenoids, tonsils, thymus and spleen. Additional sound/vibration and thermal stimuli as described above may also be applied. This will enhance the activity of immune cells, helping to fight aging, cancer and infection. The primary lymph node may be selected from a facial lymph node, a cervical lymph node, an supraclavicular lymph node, a subclavian lymph node, an supratrochlear lymph node, an axillary lymph node (an axillary lymph node), an inguinal lymph node, or a combination thereof. The device may be a red/NIR light or a device that can be attached to the neck, such as those previously described (e.g. similar to a scarf or those in fig. 12) or in the form of similar clothing with stimulation means as described above, fixed to the above-mentioned target area or other structural forms that can cover the lymph nodes. It may be a pouch or a soft pillow-like device with optional fastening means, such as straps/bands, suitable for placement under the armpit and over the inguinal lymph node area, containing the aforementioned stimulation means. It can be used by cancer patients to improve immunity to treat cancer. Light irradiation and heating can be applied to the tumor draining lymph node area or all major lymph nodes throughout the body. The user may use it to stimulate the target area for 10 minutes to 2 hours per day. The light wavelength may be 550-1100nm as previously described, for example light having a peak wavelength at 590nm or 670nm or 780nm or 790nm or 808nm or 810nm or 850nm or 980nm or 1064nm or a combination thereof. In some embodiments, it is selected from red/NIR (near infrared), such as those having peaks at 633, 670, 810, 850, 980, and 1064 nm. In some embodiments, itHas a peak wavelength of 808-820 nm. In some embodiments, it has a peak wavelength at 633nm or 670nm or 810nm or 850 nm. In some embodiments, the light intensity may be 10-1000mW/cm ² 。

An example of a small pillow-shaped device placed under the armpit to stimulate the underarm lymph nodes is shown on the left side of fig. 23. The surface of the LED lamp is provided with a plurality of 810nm infrared LEDs and 655nm red LEDs, and a heater is arranged in the LED lamp to keep the surface temperature at 40-55 ℃. It also has an elastic cord so that the user can hang the cord over the shoulder to secure the device under the arm. A speaker/vibrator may also be incorporated to provide mechanical stimulation and the stimulation pulses may be at the previously disclosed brain wave frequencies or higher (e.g., 100Hz to 10 khz). Fig. 23 right shows an example of a device in the form of an undergarment having a plurality of NIR LEDs and red LEDs on the skin-contacting surface, and a heating film to provide light and heat stimulation to the inguinal lymph node area of the user. In one example, a volunteer is illuminated with 650-670nm red and 850nm NIR LEDs at a total power level of 10W, and his axillary and inguinal lymph node areas are subjected to red and NIR radiation and heat stimulation of these areas by maintaining the skin contact surface between 40-50℃, for 30 minutes to 1 hour each, 1-3 times a day, for one month. Volunteers reported an increase in immunity and energy levels.

The red/NIR stimulation device (e.g., LED) described above may also be incorporated into an insertable device for insertion into the mouth or ear or nose or vagina or anus to apply the red/NIR stimulation described above to those interior areas of the body cavity to treat infections, inflammation, tissue damage, ulcerations and to promote cell growth/tissue repair and nerve growth therein. It is also possible to incorporate therein the above-mentioned sound/vibration/thermal stimulation generating means to apply the above-mentioned sound/vibration/thermal stimulation to these areas to enhance the therapeutic effect. The device has one or more light-transmissive windows made of a light-transmissive material to allow light generated by the internal LED to pass therethrough. Its structure may contain a bendable/flexible region to enable it to reach a target area of interest, such as an infected area or a lymph node area near the site of infection. Such asAs shown at the top of fig. 24, it contains a compartment with batteries and control circuitry inside, which allows the user to hold it by hand. The insertable shaft/tip portion has an LED inside to produce red and/or NIR light stimulation and an optional heating and vibration means inside. For use in different body cavities it may have different sizes, for example a smaller size for the ear and a larger size for the mouth. It can be inserted into oral cavity to treat oral ulcer by irradiating ulcer area, treat infection and inflammation by irradiating tonsil, or treat other oral cavity infection such as gingival/tooth infection by irradiating infection area or lymph node near infection position. It may also contain heating means to provide a thermal stimulus and means to provide a mechanical stimulus such as a sound or vibration stimulus. In some embodiments, the irradiation may be for 5-30 minutes, 1-3 times per day, until the desired effect is achieved. It can also be inserted into the vaginal cavity to treat infections and inflammation therein and to improve reproductive health. The lollipop-shaped insertable apparatus at the bottom of fig. 24 has a flexible region connecting the light emitting portion and the battery/control portion so that the user can bend it to reach the desired stimulation area. In some embodiments, the device comprises a plurality of 650-670nm red LEDs and 810-850nm NIR LEDs, which may provide 5-100mW/cm ² Light radiation of an intensity, a heater built in to maintain its skin contact surface between 40-50 degrees provides thermal stimulation to the treatment area. The stimulation pattern, time, temperature, light intensity and wavelength can be adjusted by the control means of the device. The device may also comprise means for generating a cooling stimulus (e.g. 5-15℃ for the treatment area), which may be applied to the treatment area. The cooling stimulus can reduce pain and inflammation.

The device of fig. 25 is used for insertion into the anus to treat hemorrhoids. The top insertable portion is used to stimulate the inside of the rectum to treat internal hemorrhoids and the bottom portion is used to stimulate the external area to treat external hemorrhoids. In some embodiments, the device comprises a device that can provide 5-100mW/cm ² A plurality of red LEDs and NIR LEDs of light radiation of intensity. It may also comprise heating means to provide thermal stimulation, e.g. 38-50 degrees of heating, to the anal region and mechanical stimulation, e.g.Sound or vibration stimulation. It may also be inserted into the vagina to improve tissue repair/healing and treat vaginal disorders such as local infections and relieve discomfort. The stimulation pattern, time, temperature, light intensity and wavelength can be adjusted by the control means of the device.

Another form of the device has a hemorrhoid cushion-like configuration, on which a person sits to provide light and heat stimulation to the anal region or genital region or both, and optionally vibration stimulation to the skin contact area of the buttocks. It has a raised cushion area to allow a person to sit on it and optionally contains a vibrator and heating element to provide vibratory and/or thermal stimulation to the buttocks. The mat may be of any shape suitable for a person to sit on, for example square or doughnut or pillow shaped. It has a recessed area or an aperture in the middle of the mat for receiving one or more red/NIR LEDs (e.g. 600-900nm wavelength) and a heating element such as a heating lamp (e.g. FIR lamp), a polymeric PTC heating element or a ceramic PTC heater or those previously described. It may also contain a fan to blow hot air generated by the heating element to the anogenital area and to prevent overheating of the device. When a person sits on his anus/genital area will be on top and exposed to the concave/pore area to receive light and heat stimuli. The heat level should be at a level that does not cause damage to the skin (e.g., temperature within 40-60 degrees) and can be controlled through a control interface. It can be used for improving tissue repair/healing in the genital area, treating hemorrhoids or vaginal conditions, such as local infections and relieving discomfort, for example, at a level of stimulation comfortable for the user for 10-30 minutes per day. It can also be used to improve the production of sex hormones by irradiating the genital area, such as the testis. As shown in the upper view of fig. 26, the O-ring soft seat cushion has a depressed area in the middle. The walls and bottom of the recessed area have a plurality of red and/or NIR LEDs (e.g., 600-850nm, as used in other devices described above), and the bottom has a plurality of heating elements and is adapted to receive the anogenital area, with the user sitting on the pad, providing light and thermal stimulation to his anogenital area. The control unit is connected to the device to control the stimulation pattern, intensity and time. The device may have one or more gaps/openings in the cushion to allow air circulation and to expel hot air as well as to better support the user's body and provide more stimulation area for the genital area, as shown at the bottom of fig. 26. The user can place it in a chair while working in the office to improve blood circulation, cell viability and promote tissue repair, thereby alleviating pain and accelerating healing of hemorrhoids. In one example, one volunteer received red and NIR radiation from 650-670nm red and 850nm NIR LEDs to the anogenital area with a total power of 10W and heat stimulation was performed by maintaining the device surface temperature between 40-50 degrees for 30 minutes-1 hour, 1-3 times daily for one month. Improved healing and increased libido levels were observed in the treated areas.

The devices described in the present invention may use heat stimulation. Alternatively, a cooling stimulus may be applied, or a cooling stimulus or a heating stimulus may be applied sequentially, such as a rotation of heating and cooling stimuli. The cooling effect can be achieved by using a built-in thermoelectric cooler, e.g. a Peltier element which can cool the skin contact surface to 5-15 ℃ or provide a cold air flow to the target area. Cold stimulation may be performed when there is inflammation and pain at the treatment site.

In this application, "/" denotes "and/or" and/or combinations thereof. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. All patents and publications mentioned in the specification are indicative of the levels of those skilled in the art to which the invention pertains. All patents and publications are herein incorporated by reference to the same extent as if each individual publication was specifically and individually indicated to be incorporated by reference. The above-described invention involves many well-known machines, instruments, methods and skills. The skilled person can easily find knowledge from textbooks, such as textbooks, scientific journal papers and other well-known reference resources.

Claims (9)

1. A method for improving brain function in a subject in need thereof, the method comprising administering to a skin surface of the subject a non-invasive electrical stimulus having a frequency of about 35Hz to about 45Hz while the subject is awake. Non-invasive electrical stimulation is applied to the skin of the subject at a frequency of about 0.1Hz to about 4Hz while the subject is in a sleep state.

2. The method of claim 1, wherein an additional thermal stimulus is applied to the head.

3. The method of claim 1, wherein additional infrared radiation stimulation is applied to the head.

4. The method according to claim 1, wherein the additional mechanical stimulation having a frequency of about 35Hz to about 45Hz is applied to the subject while awake and the mechanical stimulation having a frequency of about 0.1Hz to about 4Hz is applied to the subject while asleep.

5. An apparatus for improving brain function in a subject in need thereof, the apparatus comprising:

one or more infrared light emitting units facing the skin of the head; and

one or more electrode assemblies that can be attached to the skin of the head; and

at least one speaker unit.

6. The device of claim 5, wherein the electrodes can generate electrical pulses of about 35Hz to about 45Hz or about 0.1Hz to about 4Hz.

7. The apparatus of claim 5, wherein the speaker can produce sound pulses of about 35Hz to about 45Hz or about 0.1Hz to about 4Hz.

8. An eye-mask shaped device for improving eye health, the device comprising:

one or more eye-ward facing infrared LEDs; and

one or more heating elements.

9. The device of claim 8, wherein the heating element maintains a temperature of about 40 to 55 degrees at a skin contacting surface thereof.

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