Field of the Invention

[0001] The present invention relates to the field of improving health conditions in an individual by an acupressure device.

Background Art

[0002] Bioelectronic medicine progressively comes into focus as a nonpharmaceutical treatment option for various diseases. Specifically, electrical stimulation of the auricular vagus nerve is an emerging technology in the field of bioelectronic medicine with applications in therapy. A large number of physiological processes and bodily states are associated with information transfer between the brain and body. These include diseases mitigating effects and sustainable therapeutic applications ranging from chronic pain diseases, neurodegenerative and metabolic ailments to inflammatory and cardiovascular diseases.

[0003] Tinnitus is a phantom sound perception in the ears or head and can arise from many different medical disorders. The condition is very common with a prevalence of 10 to 15%. There is little evidence for effective tinnitus treatments until the recent years. WO2019158674 and W02021250104 for the first time disclose a device with proved effect for successfully treating tinnitus in afflicted individuals. The device exerts soft pressure at various points at the ear. The device is configured as a bracket with a silicone plug to be located at the region of the posterior auricular muscle. The bracket is made from metal and as such quite stiff and consequently not suited for bearing it during sleep.

[0004] 3D scanning of the ear and printing ear impressions is commonly used to make in-ear monitors which are specifically used by musicians, people with hearing impairments and people that have tinnitus whom need slim ear plugs to sleep. [0005] US2013/0301845A1 discloses an ear plug system comprising an ear plug device and an electronic control unit. The shape of the ear plug device is selected to comfortably fit into most adults’ ear to provide a good seal against external noises.

[0006] In order to improve the treatment of tinnitus and/or health conditions in a subject, it would be desirable to have a flexible device at hand that may also be worn during sleep. [0007] Therefore, there is still the need for flexible device for treating tinnitus and/or improving health conditions in an individual wherein the devise is specifically suited to be used during sleep.

Summary of invention

[0008] It is the object of the present invention to provide a flexible device for treating tinnitus and/or improve health conditions in a subject. The object is solved by the subject matter of the present invention.

[0009] According to the invention, there is provided a flexible and soft device 10 which fits accurate to the individual subject’s external ear.

[0010] One embodiment of the invention relates to a method for producing an individual device 10 for improving health conditions in a subject, comprising: scanning the geometry of the outer ears, producing a 3D-model of the individual device 10, and manufacturing the device 10 specifically adapted to the individual geometry of the outer ears of the subject.

[0011] Specifically, the method for producing an individual device 10 for improving health conditions in a subject, comprises: scanning the geometry of the outer ears; producing a 3D-model of the individual device 10; and manufacturing the device 10; wherein the device 10 is specifically adapted to the individual geometry of the outer ears of the subject; to apply pressure to the external ear in a way that the position of the pinna is changes; to exert pressure on acupressure points around to the external ear; and wherein the device 10 is flexible.

[0012] Alternatively, a molding material is applied behind the pinna by means of an application device in order to mold the area between the pinna and the skull.

[0013] Suitable molding materials are for example selected from the group consisting of monophase impression materials, biphasic impression materials, double-mixed materials or alginates.

[0014] Further provided is a kit comprising the molding material, an application device and optionally a processing device punch device in order to bring the impression material into shape after curing. [0015] The kit may further contain fixing means in order to secure the plastic impression behind the ear when worn. This is advantageous since the device is intended to be worn in particular while sleeping, thus preventing it from slipping while sleeping.

[0016] A further aspect of the invention relates to a method for producing an individual device for treating a tinnitus condition and/or improving other health conditions, comprising the steps:

(a) applying an impression material to the area behind the pinna and the skull,

(b) allowing the impression material to cure,

(c) removing the cured material; and optional

(d) process the surface of the impression of the ear geometry.

[0017] In order to obtain a smooth surface of the impression, it may be necessary to manually process the surface of the impression by milling, polishing, smoothing, etc. Specifically, the surface of the impression of the ear geometry is smoothened after curing. This surface treatment can be carried out, for example, by means of a processing device suitable for this purpose, such as a stamping device.

[0018] A further embodiment relates to the method as described herein, wherein a silicone impression material is applied to the area between the pinna and the skull with a manual impression gun. According to one embodiment of the invention, a soft vinyl polysiloxane material may be chosen for its low viscosity. When applied, the soft malleable material entered area and cured to the shape of the area between the pinna and head. A fingernail may be used to gently touch the mold to make sure it was set before removing it from the area. A typical set of molds from one subject is depicted in Fig. 2.

[0019] A further embodiment relates to the method as described herein, wherein the device 10 comprises an approximately straight portion 20 having circular portion 21, and a curved portion 30, and wherein the device is configured to surround the outer ear.

[0020] A further embodiment relates to the method as described herein, wherein the curved portion 30 has a smaller diameter at the beginnings 40, 50 and thickens towards the middle.

[0021] A further embodiment relates to the method as described herein, wherein the device 10 is manufactured as one piece. [0022] Specifically, the device 10 comprises a straight portion 20 which is adapted to rest in front of the ear, a curved portion 30 which is adapted to rest behind the ear, and a circular portion 21 which is located in the middle of the straight portion 20.

[0023] One embodiment of the invention relates to an individual device 10 produced by a method as described herein, wherein the device fits accurate to the individual subject’s outer ear.

[0024] Specifically, the individual device 10 produced by a method as described herein relates to the device 10 which fits accurate to the individual subject’s outer ear; and wherein the device 10 is specifically adapted to the individual geometry of the outer ears of the subject; to apply pressure to the external ear in a way that the position of the pinna is changes; to exert pressure on acupressure points around to the external ear; and wherein the device 10 is flexible.

[0025] One embodiment of the invention relates to the individual device 10 as described herein, wherein the approximately straight portion 20 of the device rest in front of the ear and the curved portion 30 rest behind the ear.

[0026] A further embodiment relates to the method as described herein, wherein the curved portion 30 stimulates various acupressure points behind the ear.

[0027] A further embodiment relates to the method as described herein, wherein the circular portion 21 stimulates acupressure points in the front ear.

[0028] A further embodiment relates to the method as described herein, wherein the curved portion 30 exerts stimuli to the auricular vagus nerve.

[0029] One embodiment of the invention relates to the use of the individual device 10 as described herein for improving health conditions in a subject.

[0030] A further embodiment relates to the use as described herein, wherein the curved portion 30 of the device changes the position of the pinna and stimulates various auricular acupressure points.

[0031] A further embodiment relates to the device 10 as described herein, for use in the treatment of tinnitus.

[0032] A further embodiment relates to the use of the individual device 10 as described herein, wherein the stimulation of the vagus nerve affect multiple physiological functions. [0033] A further embodiment relates to the use of the individual device 10 as described herein, wherein the multiple physiological functions are selected from the group consisting of neurological disorder, psychometric functions, metabolic syndrome, cardiovascular disorders, and pain.

Brief description of drawings

[0034] Fig. 1 depicts a device 10 comprising an approximately straight portion 20 and a curved portion 30. The straight portion 20 of the device 10 comprises an approximately circular portion 21 which is located in the middle of the straight portion.

[0035] Fig. 2 depicts a device 1 comprising an upper 2 and lower part 3 to be worn behind the ear.

[0036] Description of Embodiments

[0037] The present invention provides a flexible device to be specifically worn during sleep in order to treat tinnitus and/or to improve health condition of an individual..

[0038] The device is According to one embodiment of the invention the flexible and soft device is made to surround the outer ear. The device comprises an approximately straight portion and a curved portion. The straight portion of the device comprises a circular portion which is located in the middle of the straight portion. The straight portion may be uniform in thickness.

[0039] The curved portion of the device has at the beginnings, i.e., at the upper and lower end, the same diameter as the straight portion for connecting the curved portion and the straight portion. The curved portion thickens towards the middle section.

[0040] The external ear, the pinna is the visible part of the ear and also known as the auricle. The function of the external ear is to collect sound by acting as a funnel, amplifying the sound and directing it to the auditory canal The entire outer ear is the pinna. It is divided into different parts. Each individual’s pinna creates a distinctive imprint on the acoustic wave traveling into the auditory canal. The numerous elevations and depressions of the auricle form acoustic resonators, which are excited each time sound hits from a certain direction. This creates direction-dependent minima and maxima in the frequency spectrum of the ear signal, which are used by the ear to determine the directions of incidence such as top, bottom, front or rear directional bands. [0041] The middle ear includes the eardrum and the ossicles hammer, anvil and stirrup. The round window connects the scala tympani of the inner ear with the middle ear. The Eustachian tube, also called the ear trumpet, connects the middle ear and nasopharynx. A mechanical impedance conversion takes place in the middle ear, which enables an optimal transmission of the signal from the outer ear to the inner ear. Since the acoustic impedance of water is approximately 3000 times that of air, without the lever system formed by the ossicles, only a small part of the sound energy that reaches the eardrum would be passed on to the inner ear. [0042] The inner ear is located in a small cavity system bony labyrinth within the petrous bone, a portion of the temporal bone. In said bony labyrinth the membranous labyrinth is located, consisting of the cochlea, in which sound is converted into nerve impulses, and the organ of equilibrium. The organ of equilibrium consists of the semicircular ducts and two vesicular portions, the utriculus and the sacculus. The organ of equilibrium is used to detect changes in movement and the direction of gravity. The cochlea and the organ of equilibrium are of similar construction: both are filled with two common parallel fluid systems perilymph and endolymph and have hair cells. The hair cells are cylindrical and are named after the approximately 30 to 150 hair-like extensions at the upper end of the cell stereocilia. The hairs are bent by movements of the fluid and thereby trigger nerve impulses. At the lower end there is a synapse with a sensory neuron. Said synapse releases neurotransmitters even in the resting state. If the hair extensions are deflected by sound vibrations or changes in the movement of the head, the amount of neurotransmitters changes. In the organ of equilibrium, the hair extensions are covered with a kind of gelatinous layer, on which small crystals of calcium carbonate are deposited, which intensify the effect of movements. From the cochlea, the auditory nerve together with the nerve bundles of the organ of equilibrium extend towards the brain as the vestibulocochlear nerve.

[0043] The effects of tinnitus strongly depend on the subjective perception and assessment of the ringing in the ears. Ringing in the ears can occur on one or both sides.

[0044] Tinnitus aurium means "ringing in the ears". Medically, tinnitus is defined as an acoustic perception that arises from outside the body without a corresponding acoustic stimulus and has no information content. [0045] A distinction is made in principle between two forms. In the case of objective tinnitus, there is a body's own sound source in the ear or near the ear, whose sound emissions are perceived. This means that the sounds that often emanate from the blood vessels or the muscles actually exist and can therefore also be heard by others, even if mostly only with a stethoscope or other medical devices.

[0046] Much more common, however, is subjective tinnitus. Here, those affected perceive sounds and noises that cannot be attributed to a physical sound source and therefore cannot be heard by other people. But this does not mean that the patients only imagine the humming, buzzing, whistling, ringing, rustling or knocking. Rather, subjective tinnitus is due to incorrect information formation or processing in the auditory system, which extends from the ear via the auditory nerve to the hearing centers in the brain.

[0047] For many of those affected, however, it is not possible to determine definitely the cause of the ringing in the ears. This is called idiopathic tinnitus. [0048] Surprisingly, it has now been found that by changing the position of the outer ear relative to the rest of the ear, the sound is changed, that is to say, the sound is refracted compared to the "normal entry". This leads to a different point of impact on the eardrum. As a result, the hammer handle of the first auditory bone is moved differently and sends changed pressure signals to the next auditory bones or then on to the cochlea. In the cochlea, the sensory hairs stored in a fluid are set in motion differently. This leads to a changed conversion of the electrical signals into the brain and to a change in the learning technology of the synapses - the previous sounds are no longer heard and thus "forgotten" in the long term.

[0049] There are many causes of tinnitus, from medications and pain relievers to neck or jaw issues, sleep deprivation and stress, anxiety, and depression. Studies have revealed that tinnitus may be associated with a synchronized hyperactivity in the auditory cortex. If someone has a lot of neck tension or jaw issues, these neurons run alongside the auditory nerve. When they are overactive or on fire, that energy bleeds over to the auditory nerve triggering those neurons to fire. Resulting in the perception of sound in the auditory cortex. Approximately two-thirds of people with tinnitus are able to alter the loudness and pitch of their tinnitus via somatic maneuvers, such as jaw clenching or tensing their neck muscles. [0050] In addition to the change of the position of the outer ear relative to the rest of the ear, the device further addresses multiple acupressure points around the ear. The particularly device is configured to stimulate the muscles behind the ear such as the musculus auricularis superior and the musculus auricularis posterior. [0051] The superior auricular muscle is a muscle above the auricle of the outer ear. It originates from the epicranial aponeurosis, and inserts into the upper part of the medial surface of the auricle. It draws the auricle upwards. The musculus auricularis superior may be stimulated by the upper part 40 of the device which is positioned on the upper part of the ear.

[0052] The posterior auricular muscle is a muscle behind the auricle of the outer ear. It arises from the mastoid part of the temporal bone, and inserts into the lower part of the cranial surface of the auricle of the outer ear. It draws the auricle backwards, usually a very slight effect. The musculus auricularis posterior may be stimulated by a portion 30b of the curved part 30 of the device which is positioned on the behind the auricle.

[0053] In addition, there is a complex bidirectional interaction between tinnitus and stress. Tinnitus patients often perceive their tinnitus as stressful, intrusive and annoying and a considerable subgroup develops insomnia, attentional and psychological problems such as anxiety or depression as a consequence of the ongoing tinnitus perception. A bidirectional interaction is suggested because stress can also aggravate tinnitus perception. Many patients report that the onset of their tinnitus was preceded by stressful events. The stress level and the affective state mediate the relationship between the loudness of the tinnitus and the individually perceived distress of tinnitus. Furthermore, dynamics of emotions are associated with the course of tinnitus over time, which adds to the complex interaction of tinnitus distress, tinnitus loudness, stress, and emotional perception. This complex interaction was also observed during the first wave of the COVID-19 pandemic.

[0054] The curved portion 30 of the device may be of different thickness, depending on the condition to be treated. Same sections 30a, b of the curved portion 30 of the device may be of individually customized thickness in order to address the vagus nerve. The external ear is an ideal place for a non-invasive stimulation of the vagus nerve. In fact, the auricular branch of the vagus nerve surfaces as the auricular afferent vagus nerve and thus forms a cutaneous receptive field in the pinna of the ear. This receptive field may be stimulated by the device according to the invention.

[0055] Due to changes in the entry angle of sound, the ear noises tinnitus perceived as “bothering” are no longer perceived, since the sound impinges on the eardrum at other points of impact.

[0056] Sound changes frequency due to a different refraction change in path length. Frequency change due to change in distance between observer eardrum and sound source Doppler effect. The sound path in the ear between the outer ear and the eardrum changes. For that reason, the previous “old” frequencies, which were perceived as bothering, are no longer perceived, since they changed in terms of “frequency” and are no longer perceived in the brain. This will mainly occur at high frequencies.

[0057] Using the device according to the invention, the entry angle of sound is changed so that those affected no longer hear the previously learned bothering sounds. The device according to the invention therefore comprises a thicker part in the curved portion which is dimensioned to positioned behind the auricle. Thus, due to that thicker part of the device, the position of the auricle is changed. By changing the position of the outer ear, the entry angle of the sound into the ear is changed.

[0058] In particular, it is advantageous to apply pressure to the external ear by the device. This pressure can result in that the position of the external ear is changed so that the entry angle of the sound is also changed and thus bothering tinnitus sounds are no longer heard. The perception of noises that are not caused by acoustic signals from the environment is reduced or eliminated altogether with the device according to the invention.

[0059] The final appearance of the device 10 is dependent on the individual subject in need of such a device and of the intended function of the device. For the treatment of tinnitus, the thickness of the middle section of the curved portion of the device may be elevated in order to exert a soft pressure at various points behind the ear and to change the position of the pinna. For improving other health conditions, the thickness of the middle section of the curved portion of the device may be elevated to a minor extend in order to exert only a soft pressure at various points behind the auricle without remarkably changing the position of the pinna. [0060] Treatment of tinnitus or other health condition during sleep requires a customized device that can be easily worn during this time without interfering with sleep.

[0061] The ear is the closest organ to the brain and the most sensitive one due to its rapid transmission of stimuli. Treatment of various disorders via the ears has been known since centuries. For example, acupressure on certain points of the auricles can relieve headaches, toothaches, backaches, insomnia and other ailments.

[0062] Ear acupressure therapy has been used successfully in patients with insomnia (Cha N.H. et al., Holistic Nursing Practice 2017, 102-109). Patients suffering from tinnitus are often affected by insomnia as well. The curved portion of the individual device rests behind the ear and may stimulate respective points. Because of this stimulation, an improvement in sleep could be observed in the wearers of the device according to the invention.

[0063] 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 requires attention or action. Everyone experiences stress to some degree. The way you respond to stress, however, make a big difference to your overall well-being. Stress affects both the brain and body. Little bit of stress is good for people to perform and protect themselves but too much stress can overwhelm them leading to fight, flight or freeze response. So learning how to cope with stress is important for our mental and physical wellbeing.

[0064] Stress is a feeling of emotional or physical tension. It can come from any event or thought that makes you feel frustrated, angry, or nervous. Stress affects the psyche in the same way as it affects the state of the body. It can lead to minor and serious illnesses, such as forgetfulness and concentration problems, sleep disorders, limited performance and creativity, nervous restless behavior, and much more.

[0065] The vegetative nervous system consists of two components which are active at the same time. One part, the so-called sympathetic nervous system, provides tension, the other part, the parasympathetic nervous system, provides relaxation. Stress leads to tension, and if tension persists, the vegetative nervous system tilts into a mode of overactivation of the sympathetic nervous system, while the parasympathetic nervous system is responsible for reducing stress in the human body.

[0066] The curved portion of the individual device rests behind the ear and may stimulate respective points of the vegetative nervous system, more precisely the parasympathetic nervous system. Because of this stimulation, a reduction in stress could be observed in the wearers of the device according to the invention.

[0067] Furthermore, studies have indicated a higher prevalence of sexual problems in patients with tinnitus, in particular an association between tinnitus and erectile dysfunction ED has been established. This connection was empirically examined in a Taiwanese study (Cheng Y-F. et al., Sci Rep. 2021, 111, 6982). Consequently, successful treatment of a tinnitus disorder may lead to positive impacts on an erectile dysfunction.

[0068] For improving other health conditions, the device further comprises a more or less circular portion 21 at the approximately straight portion 20. This more or less circular portion 21 exerts soft pressure on the tragus.

[0069] The vagus nerve is the 10th cranial nerve that starts at the brainstem with two bilateral branches and widely meanders and loops within the neck, thorax, and abdomen. The vagus nerve establishes a mutual connection between the brain and major body structures as pharynx, larynx, trachea, heart, aorta, lungs, and the entire gastrointestinal tract including esophagus, stomach, liver, pancreas, and spleen. The activity of the vagus nerve is proportionally associated with health, wellbeing, relaxation, and even emotions like empathy. The vagus nerve thus plays a crucial role in determining brain-body interactions Kaniusas E., et al. (Front. Neurosci 2019, 13, 1-23).

[0070] The external ear is the only place on the body where the vagus nerve sends its only peripheral branch. The auricular branch of vagus nerve surfaces as the afferent auricular vagus nerve and thus forms a cutaneous receptive field in the pinna of the ear. This field is susceptible to external stimuli in terms of peripheral nerve stimulation. In particular, auricular vagus nerve allows for an easy external access via electrical stimulation which then connects directly and favorably the applied stimuli to the brainstem Kaniusas, 2019.

[0071] Thus, auricular vagus nerve stimulation is a peripheral, non- pharmacological and minimally invasive neuromodulation technique, altering signal processing in the central nervous system, activating reflex circuitries, exploiting brain plasticity for different therapeutic purposes, and thus, affecting profoundly different areas of the brain Kaniusas, 2019.

[0072] Reported clinical application of the auricular vagus nerve stimulations in humans relate to neurological disorders, psychometric functions, metabolic syndrome, cardiovascular disorders, and pain. A positive influence of stimulation of auricular vagus nerve is also foreseen for epilepsy, depression, stroke, Alzheimer’s disease, and many other disorders.

[0073] Up to date, the auricular vagus nerve is primarily electrically stimulated. Surprisingly, it was found that the device according to the invention also stimulates the auricular vagus nerve through the almost circular part of the approximately straight portion. Upon wearing the device, the circular portion is located at the concha, thus stimulating the auricular vagus nerve.

[0074] The device according to the invention is specifically suited for the stimulation of the auricular vagus nerve. According to one embodiment of the invention, the device is configured to be worn while sleeping. This is particularly advantageous because the individual subject must not waste time for attending respective premises where the bioelectronic medicine is applied via electrical stimulation. The device is intended for treating tinnitus and/or stimulating the auricular vagus nerve while sleeping. However, if required, the device may also be worn when awake.

[0075] The device may be made as one piece or consist of several pieces which are connected to form one piece. In case the device if produced as one-piece it must be of a certain flexibility in order to be placed around the outer ear. For some embodiments, it may be advantage to provide a device with two or more pieces which are connected to one piece when placed around the outer ear. This will allow in same cases a convenient way to place the device around the outer ear. The two or more pieces are connected in order to gain one piece and to ensure the right fit. [0076] The two or more parts may be connected via a plug-in connector, a connection assembly or via a hook-and-loop-fastener.

[0077] The device may be made of synthetic material, e.g., of a plastic material. Preferably, the device is made by a 3D print device. Typical materials for 3D printing are silicones, polyurethanes and hydrogels. According to the invention, the individual device consists of elastomers, preferably of one and/or more crosslinking silicones and/or polyurethanes and/or hydrogels, also referred to as an emulsion with crosslinking agents as ink or 3D printing ink.

[0078] The device may be produced by additive manufacturing techniques. Additive manufacturing techniques comprise a process involving putting together or combining materials in order to manufacture 3D products from 3D modeling data, typically a computer-assisted design file, usually layer by layer.

[0079] In order to fit accurate to the individual subject’s outer ear, ear scanning is an important step in manufacturing the device. The detailed geometry of the subject’s ear needs to be obtained in order to acquire a perfect model of the individual’s ear geometry. Thus, according to the invention, the individual’s ear geometry encompasses the external ear, including the helix, the concha, the tragus, and the lobule and is obtained by scanning the external ear. The scan of the external ear is then converted into a model of the device e.g., to a computer-aided design CAD model or other digital representation of the model directly into the physical device. The model of the device may then be manufactured, preferably via additive manufacturing techniques, such as 3D printing.

[0080] Additive manufacturing systems make a three-dimensional 3D object through the solidification of layers of build material. Additive manufacturing systems make objects based on data in a 3D model of the object generated, for example, with a computer-aided drafting CAD computer program product. The model data is processed into slices, each slice defining portions of a layer of build material that is to be solidified.

[0081] The 3 D-printing method may be a method step in the manufacturing of the device in one batch by additive manufacturing using a layer-by-layer technique and using a 3D printing device.

[0082] According to the invention, a composition of a silicone 3D printing ink is provided as an additive manufacturing ink, which is free of any solvents, biocompatible with the human body and non-toxic, used for the manufacture of such a device Fig. 1.

[0083] 3D printed silicone removes the model and mold steps entirely, and simply prints the final part. Silicone materials for 3D printing must provide specific material properties, e.g., excellent thermal stability, available in different hardness’s, water resistance and suitability as a sealant, UV resistance, oxidation resistance, compression and shear resistance, flame retardancy, electrical insulation, biocompatibility, optionally suited for sterilization, color and translucency options. The silicone material may be blended with additives such as curing agent or other polymers. One suitable material is for example, ACEO® Silicones Wacker Chemie AG.

Examples

[0084] The Examples which follow are set forth to aid in the understanding of the invention but are not intended to, and should not be construed to limit the scope of the invention in any way.

Case Study

[0085] A longitudinal observation study is investigating the temporal development of tinnitus and related symptoms during a combination treatment. The combined treatment consists of the wearing the device around the ears during sleep together with a smartphone app that provides self-help tips to the participants. The participants provide self-reports about tinnitus loudness, tinnitus stress, mood, stress level, tensions in the jaw and neck muscles as outlined in Table 1. In addition to these questions, participants answer if they were using the device and entered comments in a free text field.

Table 1. Questions for ecological momentary assessment

[0086] The treatment and app assessment are done under naturalistic conditions and the data collection is reduced to a minimum to assess the development of tinnitus and other health conditions with high ecological validity and low intrusion to everyday life. Only the short questions within the app needs to be answered by the participants.