Pressure application device

Abstract

The present invention relates to a device for improving the health of a subject, configured to be mounted on an ear of the subject, comprising an upper shackle, a lower shackle and at least two pressure elements, the lower shackle having a track and a curved end along a longitudinal side of the lower shackle.

Description

Technical Field

[0001] The present invention relates to the field of improving the health of an individual through acupressure devices. Background Art

[0002] Bioelectronic medicine is gaining attention as a non-drug treatment option for a variety of diseases. Specifically, electrical stimulation of the auricular vagus nerve is an emerging technology in the field of bioelectronic medicine for therapeutic applications. Numerous physiological processes and bodily states are associated with information transfer between the brain and the body. These include disease-modifying effects and sustainable therapeutic applications ranging from chronic pain disorders, neurodegenerative and metabolic diseases to inflammatory and cardiovascular diseases.

[0003] Tinnitus, hallucinations in the ears or head, can be caused by a variety of medical conditions. It's a very common condition, affecting 10% to 15% of people. Until recent years, there was little evidence that tinnitus treatments were effective. WO2019158674 and WO2021250104 disclose for the first time a proven device for successfully treating tinnitus in affected individuals. The device consists of a single pressure element that applies soft pressure at various points on the ear. It is configured as a bracket with a silicone plug, designed to rest in the area of ​​the posterior auricular muscle. The device is specifically designed for the treatment of tinnitus.

[0004] US2013 / 0301845A1 discloses an earplug system comprising an earplug device and an electronic control unit. The earplug device can be configured to further include acupuncture nodes for applying pressure. This device includes a programmable microchip located within the earplug and can be customized to provide user-specific soothing sounds to induce and maintain high-quality sleep.

[0005] However, subjects with tinnitus often have further health impairments, such as stress, pain, or psychometric dysfunction, which lead to further impaired health status.

[0006] Therefore, there remains a need for a device for treating tinnitus and / or improving an individual's health. Summary of the Invention

[0007] It is an object of the present invention to provide a device for treating tinnitus and / or improving the well-being of a subject. This object is solved by the subject matter of the present invention.

[0008] According to the present invention, there is provided a device 100 for wearing behind the outer ear of an individual subject for improving the subject's health.

[0009] One embodiment of the present invention relates to a device 100 for improving health, which is configured to be mounted on the ear of a subject, and includes an upper shackle 110, a lower shackle 120, and at least two pressure elements 300, wherein the lower shackle 120 has a track 122 and a curved end along a longitudinal side of the lower shackle 120.

[0010] The upper shackle 110 and the lower shackle 120 are connected by a connecting device 130, and the upper shackle 110 and the lower shackle 120 can move relative to each other. At least two pressure members 300 are installed on the track.

[0011] The upper shackle 110 and the lower shackle 120 may include a soft coating.

[0012] In one embodiment, element 300 includes 3 to 10 burls.

[0013] In one embodiment of the present invention, two, three, or four pressure elements 300 are installed in the track 122 .

[0014] According to one embodiment of the present invention, at least one pressure element 300 is located on the lower shackle 120 and is movable along the track 122 .

[0015] Another embodiment relates to a device 100 in which a pressure element 310 is fastened to the lower shackle 120 beside the connecting device 130 .

[0016] One embodiment of the present invention relates to a device 100 comprising an electrical stimulation device. The electrical stimulation device may be comprised in a pressure element 300.

[0017] When the device 100 is worn, the upper hook 110 is located on the upper side of the ear, and the lower hook 120 is located behind the auricle, with the curved end of the lower hook 120 extending to the tragus.

[0018] The device 100 is specifically configured to stimulate various acupuncture points around the ear when worn. Thus, as described herein, after wearing the device 100, the subject's health condition improved.

[0019] Another embodiment relates to the use of the device 100 as described herein for improving the health of a subject. A pressure element 300 located on the lower hook 120 of the device 100 changes the position of the pinna and / or stimulates various ear acupuncture points.

[0020] The pressure element 300 may comprise several burls. According to one embodiment, the pressure element 300 comprises 2, 3 or more burls.

[0021] One embodiment of the present invention relates to the use of the apparatus 100 for the non-invasive treatment of tinnitus.

[0022] Another embodiment involves the use of device 100 wherein pressure element 300 of device 100 stimulates the vagus nerve, thereby positively affecting various physiological functions of the subject.

[0023] One embodiment of the present invention is directed to a single device 100 as described herein, wherein the upper hook 110 of the device is placed on the upper side of the ear above the pinna and the lower hook 120 is placed behind the pinna and extends to the tragus around the lower pinna.

[0024] Another embodiment is directed to a device as described herein, wherein the pressure element 300 stimulates various acupuncture points around the ear.

[0025] Another embodiment is directed to the device 100 as described herein, wherein the curved portion of the lower hook 120 extends to the tragus and stimulates an acupuncture point on the front of the ear.

[0026] Another embodiment is directed to the device 100 as described herein, wherein the pressure element 300 applies stimulation to the auris vagus nerve.

[0027] One embodiment of the present invention relates to the use of the device 100 as described herein for improving the health of a subject.

[0028] Another embodiment involves use as described herein, wherein the pressure element 300 of the device 100 changes the position of the auricle and stimulates various auricular acupuncture points.

[0029] Another embodiment relates to the apparatus 100 as described herein for treating tinnitus and / or improving health conditions.

[0030] Another embodiment involves the use of the device 100 as described herein, wherein stimulation of the auricular vagus nerve affects various physiological functions.

[0031] Another embodiment relates to the use of the device 100 as described herein, wherein the plurality of physiological functions is selected from the group consisting of neurological diseases, psychometric functions, metabolic syndrome, cardiovascular diseases, and pain. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] Figure 1 A device 100 comprising two pressure elements 310 , 320 is depicted.

[0033] Figure 2 A device 100 comprising two pressure elements 310 , 320 is depicted.

[0034] Figure 3A 、 3B3C depicts a pressure element 300 of a different shape. DETAILED DESCRIPTION

[0035] The present invention provides a device specifically configured for treating tinnitus and / or improving the health of an individual.

[0036] The device 100 comprises an upper hook 110 connected to a lower hook 120 by a connecting means 130. The device is intended to be worn behind the outer ear ( Figure 1 、 2 ).

[0037] The upper shackle 110 is slightly curved to fit over the upper side of the subject's ear. To prevent pressure marks, the upper shackle can include a soft coating. These coatings can be made of a suitable material, such as silicone, rubber, plastic, fabric, felt, foam, gel, elastomer, or the like. The coating can cover the majority of the upper shackle or be formed as an inlay.

[0038] The lower hook 120 has a slightly curved portion, followed by a curved portion that surrounds the lower auricle and a generally straight portion that extends to the tragus. The slightly curved portion of the lower hook has a track for mounting the pressure element 300. The track can be configured as an opening, a notch, a slot, a gap, etc. The pressure element 300 is fixed in the track. The position of the pressure element 300 can then be variably moved along the track so that the pressure element 300 can be individually adapted to the needs of the subject ( Figure 1 、 2 ).

[0039] The pressure element 300 is mounted in the rail using suitable means. The fixing mechanism still allows the pressure element 300 to move along the rail, allowing for individual customer adjustments. For example, a rotary joint can be used to enable the pressure element 300 to move along a linear guide system. Alternatively, the pressure element 300 can be fixed in the groove, for example, using a clamping connection.

[0040] The upper shackle 110 and the lower shackle 120 may be connected by a connection means 130, such as a hinge or a swivel joint.

[0041] The upper and lower shackles can be made of stable materials, for example stainless steel, titanium, spring steel, other metals and metal alloys, plastics etc., are particularly suitable.

[0042] Pressure element 300 can have different shapes and sizes (see FIG3 ). Pressure element 300 can include 2, 3, 4, 5, 6, 7, 8, or 9 burls. These burls additionally apply pressure to the auris vagus nerve. The burls can be made of soft tissue, such as silicone, rubber, plastic, fabric, felt, foam, gel, rubber, or similar materials.

[0043] The pressure element 300 can be made of various materials. In principle, any material suitable for forming a correspondingly shaped body and providing comfort can be used. For example, the pressure element can be made of plastic, fabric, felt, foam, gel, rubber, elastic tape, or similar materials. The pressure point body can be made of a foam material, an elastically deformable material, or a plastic material (e.g., polypropylene).

[0044] The outer ear, or pinna, is the visible part of the ear, also known as the auricle. The outer ear acts as a funnel to collect sound, amplify it, and direct it to the ear canal. The entire outer ear is the pinna, which is divided into different sections. Each person's pinna leaves a unique imprint on sound waves entering the ear canal. The numerous ridges and valleys of the pinna form acoustic resonators that are excited every time sound strikes from a certain direction. This creates directionally dependent minima and maxima in the frequency spectrum of the ear signal, which the ear uses to determine the direction of incidence, such as top, bottom, front, or back (directional bands).

[0045] The middle ear consists of the eardrum and the auditory ossicles: the malleus, incus, and stapes. The round window connects the scala tympani to the middle ear. The Eustachian tube, also known as the ear trumpet, connects the middle ear to the nasopharynx. Mechanical impedance conversion occurs in the middle ear, enabling optimal signal transmission from the outer ear to the inner ear. Because the acoustic impedance of water is approximately 3,000 times that of air, without the lever system formed by the auditory ossicles, only a small fraction of the sound energy reaching the eardrum would be transmitted to the inner ear.

[0046] The inner ear is located in a small system of cavities (the bony labyrinth) within the petrous bone, a part of the temporal bone. The membranous labyrinth, located within this bony labyrinth, consists of the cochlea and the balance organ, where sound is converted into nerve impulses. The balance organ consists of a semicircular duct and two vesicular parts: the utricle and the saccule. The balance organ detects movement and changes in the direction of gravity. The cochlea and balance organ are structurally similar: both are filled with two common, parallel fluid systems (perilymph and endolymph) and contain hair cells. Hair cells are cylindrical and named for the approximately 30 to 150 hair-like extensions (stereocilia) at their upper ends. These hairs bend in response to fluid movement, triggering nerve impulses. At their lower ends, they form a synapse with a sensory neuron. These synapses release neurotransmitters even in the resting state. If these hair extensions are deflected by sound vibrations or changes in head movement, the amount of neurotransmitter released changes. In the balance organ, the hair extensions are covered with a gel layer on which small crystals of calcium carbonate are deposited, which enhance the effect of movement. From the cochlea, the auditory nerve, along with nerve bundles from the balance organs, extends toward the brain as the vestibulocochlear nerve.

[0047] The impact of tinnitus depends largely on the subjective perception and assessment of the ringing in the ears. The ringing in the ears may occur on one or both sides.

[0048] Tinnitus means "ringing in the ears." Medically, it is defined as an acoustic perception without information content that originates from outside the body in the absence of a corresponding acoustic stimulus.

[0049] In principle, two forms are distinguished. In objective tinnitus, there is a sound source in or near the ear that the subject perceives as emitting sound. This means that sounds, which often originate from blood vessels or muscles, are actually present and can therefore be heard by others, even if they are usually only heard with a stethoscope or other medical equipment.

[0050] More common, however, is subjective tinnitus. Here, the affected person perceives sounds and noises that cannot be attributed to a physical source and are therefore inaudible to others. This does not mean, however, that the sufferer merely imagines the buzzing, beeping, whistling, ringing, rustling, or knocking. Rather, subjective tinnitus results from incorrect formation or processing of information in the auditory system, which extends from the ear via the auditory nerve to the auditory center in the brain.

[0051] However, for many affected people, it is impossible to determine the exact cause of the ringing in the ears. This is called idiopathic tinnitus.

[0052] Surprisingly, it has now been discovered that by changing the position of the outer ear relative to the rest of the ear, the sound is altered – that is, it is refracted compared to its "normal" entry point. This leads to a different point of impact on the eardrum. As a result, the malleus (handle) of the first auditory bone moves differently, sending altered pressure signals to the next auditory bone and then to the cochlea. In the cochlea, the sensory hairs, which are stored in fluid, move differently. This leads to a change in the conversion of electrical signals to the brain and a change in the learning technology of the synapses – the previous sound is no longer heard and is therefore "forgotten" in the long term.

[0053] Tinnitus has many causes, ranging from medications and painkillers to neck or jaw problems, sleep deprivation and stress, anxiety, and depression. Research suggests that tinnitus may be linked to synchronized hyperactivity in the auditory cortex. If someone has a lot of neck tension or jaw problems, these neurons work in conjunction with the auditory nerve. When they become overactive, or excited ("on fire"), this energy flows to the auditory nerve, triggering these neurons to fire. This leads to the perception of sound in the auditory cortex. About two-thirds of people with tinnitus are able to change the loudness and pitch of the tinnitus with physical actions, such as clenching their teeth or tightening their neck muscles.

[0054] In addition to changing the position of the outer ear relative to the rest of the ear, the device can also address multiple acupuncture points around the ear. This particular device is configured to stimulate the muscles behind the ear, such as the superior and posterior auricularis muscles.

[0055] The superior auricularis muscle is a muscle located above the pinna of the external ear. It originates from the cranial aponeurosis and inserts into the upper part of the inner surface of the pinna. It pulls the pinna upward. The pressure element of this device stimulates the superior auricularis muscle.

[0056] The posterior auricularis muscle is a muscle located behind the pinna of the external ear. It originates from the mastoid portion of the temporal bone and inserts into the inferior cranial surface of the pinna of the external ear. It pulls the pinna posteriorly, usually with a very slight effect. A pressure element of the device positioned behind the pinna can stimulate the posterior auricularis muscle. The position of the pressure element can be varied by the client to target specific stimulation or acupressure points.

[0057] Furthermore, a complex bidirectional interaction exists between tinnitus and stress. Tinnitus patients often perceive their tinnitus as stressful, intrusive, and annoying, and a significant proportion experience insomnia, concentration, and psychological problems, such as anxiety or depression, due to the persistent perception of tinnitus. A bidirectional interaction is suggested, as stress can also worsen tinnitus perception. Many patients report that their tinnitus episodes were preceded by stressful events. Stress levels and affective states modulate the relationship between tinnitus loudness and the individual's perceived tinnitus distress. Furthermore, the dynamics of emotion over time are associated with the course of tinnitus, adding to the complex interplay of tinnitus distress, tinnitus loudness, stress, and emotional perception. This complex interaction has also been observed during the COVID-19 pandemic.

[0058] Depending on the condition being treated, the pressure element of the device can have different shapes, sizes, and thicknesses. The pressure element of the device can be individually customized in size, shape, and thickness to specifically target the auricular vagus nerve. The outer ear is an ideal location for non-invasive stimulation of the vagus nerve. Indeed, the auricular branch of the vagus nerve arises as an auricular afferent, thus forming a cutaneous receptive field in the auricle. The device according to the present invention can stimulate this receptive field.

[0059] Due to the change in the angle of incidence of the sound, ear noises (tinnitus) that were perceived as "disturbing" are no longer perceived, since the sound hits the eardrum at a different impact point.

[0060] Sound changes frequency due to different refractions (a change in path length). The frequency shifts due to the changing distance between the listener (eardrum) and the sound source (the Doppler effect). The sound path in the ear, between the outer ear and the eardrum, changes. As a result, "old" frequencies that were previously perceived as disturbing are no longer perceived because they have changed in frequency and are no longer perceived by the brain. This occurs primarily at high frequencies.

[0061] Using the device according to the present invention, the angle of sound entry is altered so that the affected person no longer hears the previously learned interfering sound. The device according to the present invention includes a pressure element that is individually sized for positioning behind the pinna. Consequently, the position of the pinna is altered by the device's pressure element. By changing the position of the outer ear, the angle of sound entry into the ear is also altered.

[0062] In particular, applying pressure to the outer ear using the device is advantageous. This pressure changes the position of the outer ear, thereby altering the angle of sound entry, so that the tinnitus is no longer audible. Using the device according to the present invention, the perception of noise that is not caused by acoustic signals from the environment can be reduced or completely eliminated.

[0063] The number of pressure elements used on the device depends on the individual requiring the device and the device's intended function. For tinnitus treatment, one pressure element is located in the middle of the device to apply soft pressure to the various stimulation points behind the ear and change the position of the pinna. To improve other health conditions, the pressure element can be smaller in size and thickness to apply only soft pressure to the stimulation points behind the pinna without significantly changing the position of the pinna.

[0064] A pressure element 310 is fixed to the upper side of the lower shackle, close to the connection device, in order to target the stimulation point there.

[0065] Treating tinnitus or other health conditions during sleep requires a custom-made device that can be worn easily without disrupting sleep.

[0066] The ear is the organ closest to the brain and is also the most sensitive, as it transmits stimuli quickly. Treating various ailments through the ear has been known for centuries. For example, pressing certain acupressure points on the pinna can relieve headaches, toothaches, backaches, insomnia, and other ailments.

[0067] Auricular acupressure therapy has been successfully used in patients with insomnia (Cha NH et al., Holistic Nursing Practice 2017, 102-109). Tinnitus sufferers are also often affected by insomnia. The curved portion of a single device, positioned behind the ear, stimulates the corresponding points. This stimulation can improve sleep in wearers of the device according to the present invention.

[0068] Stress can be defined as any type of change that causes physical, emotional, or psychological strain. Stress is your body's response to anything that demands attention or action. Everyone experiences stress to some degree. However, how you cope with stress can have a significant impact on your overall well-being. Stress affects both the brain and the body. A little bit of stress can benefit people's performance and protect them, but too much stress can overwhelm them, leading to fight, flight, or freeze responses. Therefore, learning how to cope with stress is important for our physical and mental health.

[0069] Stress is a feeling of emotional or physical tension. It can stem from any event or thought that makes you feel frustrated, angry, or nervous. Stress affects the mind in the same way it affects the body. It can lead to both mild and severe conditions, such as forgetfulness and concentration problems, sleep disturbances, limited performance and creativity, and nervous behavior.

[0070] The autonomic nervous system consists of two simultaneously active parts. One, the sympathetic nervous system, provides tension, while the other, the parasympathetic nervous system, provides relaxation. Stress causes tension, and if tension persists, the autonomic nervous system shifts into a mode of overactivation of the sympathetic nervous system, while the parasympathetic nervous system is responsible for alleviating stress.

[0071] The pressure element of the device is located behind the ear and can stimulate various points of the autonomic nervous system, more precisely various points of the parasympathetic nervous system. Due to this stimulation, a reduction in stress can be observed in the wearer of the device according to the invention.

[0072] In addition, studies have shown that tinnitus patients have a higher prevalence of sexual problems, and in particular, an association between tinnitus and erectile dysfunction (ED) has been established. This association was empirically tested in a study in Taiwan, China (Cheng YF. et al., Sci Rep. 2021, 11(1), 6982). Therefore, successful treatment of tinnitus disorder may have a positive impact on erectile dysfunction.

[0073] To improve other health conditions, the lower hook of the device extends toward the tragus. This extension is designed to apply gentle pressure to the tragus.

[0074] The vagus nerve is the 10th cranial nerve that originates in the brainstem and has two bilateral branches that wind and loop extensively in the neck, chest, and abdomen. The vagus nerve establishes interconnections between the brain and major body structures, such as the pharynx, larynx, trachea, heart, aorta, lungs, and the entire gastrointestinal tract, including the esophagus, stomach, liver, pancreas, and spleen. Vagus nerve activity is proportionally correlated with emotions such as well-being, happiness, relaxation, and even empathy. Therefore, the vagus nerve plays a crucial role in determining brain-body interactions (Kaniusas E. et al., Front. Neurosci 2019, 13, 1-23).

[0075] The external ear is the only body part to which the vagus nerve sends its sole peripheral branch. This auricular branch of the vagus nerve emerges as the auricular vagus nerve, forming a cutaneous receptive field in the auricle. This receptive field is readily accessible to external stimulation in terms of peripheral nerve stimulation. In particular, the auricular vagus nerve allows for easy external access via electrical stimulation, which then advantageously connects the applied stimulation directly to the brainstem (Kaniusas, 2019).

[0076] Therefore, auricular vagus nerve stimulation is a peripheral, non-pharmacological, and minimally invasive neuromodulatory technique that alters signal processing in the central nervous system, activates reflex circuits, and utilizes brain plasticity to achieve different therapeutic goals, thereby affecting different areas of the brain (Kaniusas, 2019).

[0077] Clinical applications of auricular vagus nerve stimulation in humans have been reported for neurological disorders, psychometric function, metabolic syndrome, cardiovascular disease, and pain. Stimulating the auricular vagus nerve has also been shown to have positive effects on epilepsy, depression, stroke, Alzheimer's disease, and many other conditions.

[0078] Until now, the auricular vagus nerve has primarily been stimulated electrically. Surprisingly, it has been discovered that the device according to the present invention also stimulates the auricular vagus nerve via the substantially straight, almost circular portion. When the device is worn, the pressure element rests on the outer ear, thereby stimulating the auricular vagus nerve.

[0079] The device according to the present invention is particularly suitable for stimulating the auricular vagus nerve. This is particularly advantageous because individuals do not have to waste time traveling to various locations where bioelectronic drugs are applied through electrical stimulation. The device is intended to treat tinnitus and / or stimulate the auricular vagus nerve.

[0080] According to one embodiment of the present invention, the device may optionally include an electrical stimulation device. A wide range of pulse patterns can be used with the non-invasive nerve stimulation device. The device may optionally include an electrical stimulation device that provides relief by electrically stimulating the auricular vagus nerve. Specifically, the device electrically stimulates the vagus nerve at an individual's auricular acupoint. The electrical stimulation device may be a battery-powered device that operates by transcutaneously stimulating the auricular vagus nerve.

[0081] The electrical stimulation device may be included in the housing of one of the pressure elements. Alternatively, the electrical stimulation device may be mounted on the upper or lower shackle.

[0082] Example

[0083] The following examples are intended to aid understanding of the present invention, but are not intended to, and should not be construed to, limit the scope of the present invention in any way.

[0084] Case Studies

[0085] A longitudinal observational study is investigating the temporal development of tinnitus and related symptoms during combined therapy. The combined therapy involves wearing a device around the ear and using a smartphone application to provide participants with self-help prompts. Participants provide self-reports of tinnitus loudness, tinnitus distress, mood, stress level, and jaw and neck muscle tension, as shown in Table 1. In addition to these questions, participants can also answer whether they use the device and enter comments in a free-text field.

[0086] Table 1. Questions used for ecological momentary assessment

[0087]

[0088] Treatment and app evaluations are conducted under natural conditions, with minimal data collection to assess the development of tinnitus and other health conditions, with high ecological validity and minimal disruption to daily life. Participants only need to answer brief questions in the app.

Claims

1. A device (100) for improving health, configured to be mounted on an ear of a subject, comprising: a. Upper hook (110); b. a lower shackle (120) having a track (122) and a curved end along a longitudinal side of the lower shackle; c. at least two pressure elements (300); wherein the upper shackle (110) and the lower shackle (120) are connected by a connecting device (130), and the upper shackle (110) and the lower shackle (120) can move relative to each other; and The at least two pressure elements (300) are installed in the rail (122).

2. The device (100) according to claim 1, wherein the upper shackle (110) comprises a soft coating (111).

3. The device (100) according to claim 1 or 2, wherein the curved end of the lower shackle (120) comprises a soft coating (121).

4. The device according to any one of claims 1 to 3, wherein the pressure element (300) comprises 3 to 10 burls.

5. The device (100) according to any one of claims 1 or 4, wherein two, three or four pressure elements (300) are installed in the rail.

6. The device (100) according to any one of claims 1 to 5, wherein the at least one pressure element (320) is located on the lower shackle (120) and is movable along the track (122).

7. The device (100) according to any one of claims 1 to 6, wherein a pressure element (310) is fixed to the lower shackle (110) close to the connecting device (130).

8. The device (100) according to any one of claims 1 to 7, wherein the at least two pressure elements (300) are different in shape and size.

9. The device (100) according to any one of claims 1 to 8, comprising an electrical stimulation device.

10. The device (100) according to claim 9, wherein the electrical stimulation device is included in the pressure element.

11. The device (100) according to any one of claims 1 to 10, wherein when worn, the upper hook (110) is located on the upper side of the ear, the lower hook (120) is located behind the auricle, and the curved end of the lower hook extends to the tragus.

12. The device (100) according to any one of claims 1 to 10, wherein various acupuncture points around the ear are stimulated when worn.

13. Use of the device (100) according to any one of claims 1 to 10 for improving the health of a subject.

14. Use of the device according to claim 13, wherein the pressure element located on the lower hook of the device changes the position of the pinna and / or stimulates various ear acupuncture points.

15. Use of the device according to claim 13 or 14 for the non-invasive treatment of tinnitus.

16. Use of the device according to claim 13 or 14, wherein a plurality of physiological functions are positively influenced when the pressure element stimulates the vagus nerve.

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