Trigeminal auriculotemporal occipital stimulator

Abstract

The present invention relates to a headset comprising a bilateral multimodal stimulator system for the non-invasive wireless stimulation of the trigeminocervical complex and the vagus nerve. In addition, the invention is controlled by a mobile application and / or compute, to enable the monitoring of the neurostimulation parameters as well as physiological data of the patients. The use of magnetic, electrical and mechanical stimulation of most of the nerves involved in pain processing and mood, may be used for the treatment, prevention or prophylaxis of neurological and psychiatric disorders like e.g., headache, migraine, chronic pain and depression.

Description

[0001] DESCRIPTION

[0002] TRIGEMINAL AURICULOTEMPORAL OCCIPITAL STIMULATOR

[0003] Technical Field

[0004] The present invention relates to a headset comprising a bilateral and multimodal stimulator system for the isolated or simultaneous non-invasive stimulation of the following nerve systems 1 ) trigeminocervical complex, 2) the cervical vagus nerves. In particular, the stimulator systems arranged on the adjustable headset are adapted in a manner that an electrical, mechanical, thermal or magnetic can be delivered.

[0005] Background of the invention

[0006] Neurological pain disorders or pathologies like e.g., headache or chronic pain are debilitating conditions affecting a significant portion of the population with limited effective treatment, prevention, or prophylaxis options available.

[0007] The trigeminocervical complex (TCC) refers to the relationship between the upper neck, the jaw, and trigeminal nerve, which can be associated with a wide range of conditions that affect the neck, face, and head.

[0008] It contains neurons that serve as crucial relay points for receiving pain signals from the meninges (membranes surrounding the brain) and the cervical (neck) structures. These neurons are directly involved in the transmission of pain like e.g., head pain. In addition, the trigeminocervical complex has a significant impact on the development of hypersensitivity, as well as the spread and referral of pain, commonly observed in individuals with primary headache disorders like e.g., migraine.

[0009] The trigeminocervical complex comprises various nerves, including the trigeminal nerve, the auriculotemporal nerves (ATN) and the occipital nerves.

[0010] The trigeminal nerve is anatomically divided into five segments: brainstem, cisternal, Meckel's cave and cavernous sinus, skull base and extracranial segments. Within the brainstem, it includes both sensory and motor nuclei, with the sensory component comprising four nuclei: the major sensory nucleus, the mesencephalic nucleus, the spinal trigeminal nucleus and the paratrigeminal nucleus. The nerve emerges in the mid-pons as separate sensory and motor roots, entering Meckel's cave, which contains the Gasserian ganglion. The sensory root divides into three branches — ophthalmic (V1 ), maxillary (V2), and mandibular (V3). These nerves play a crucial role in the sensation in the face of a human being as well as in some motor functions like e.g., chewing or biting.

[0011] The auriculotemporal nerves (ATN) are located at the lateral region of the head, including the pinna. ATN are tributaries of the mandibular division of the trigeminal nerve. The nerves that pick up the sensation in this area are branches of the trigeminal, facial, glossopharyngeal, vagus and posterior branch of cervical nerves. These nerves provide cutaneous sensory territories of the left and right half of the head at the level of the auriculotemporal-occipital region outside the auricle including auriculotemporal nerve (maxillary division of the trigeminal nerve), greater auricular nerve (spinal nerves C2-C3, lesser auricular nerve (spinal nerves C2-C3), auricular branch of the facial nerve, and auricular branch of the vagus nerve.

[0012] The occipital nerves are a complex of nerves that comprehend from the cervical spinal nerves C2 and C3 to the posterior scalp region. This complex consists of three nerves, the greater, the lesser, and the third occipital nerve. The principal function of the occipital nerves is to provide sensory supply to the skin in the posterior scalp and to the skin of the external ear. All three occipital nerves carry sensory fibers, but only the third occipital nerve bears some motor fibers.

[0013] The cervical vagus nerve is a branch of the vagus nerve, or the 10th cranial nerve (CN X). It is primarily associated with the parasympathetic division of the autonomic nervous system,. The vagus nerve is a mixed nerve, as it contains both afferent (sensory) and efferent (motor) fibers. This means it is responsible for not only carrying motor signals to the organs it innervates, but it also carries sensory information from these organs back to the central nervous system.

[0014] The cervical vagus nerve is a bilateral nerve with have several analgesic, antiinflimatory and antidepressive effects that modulates pain perception and mood in human being.

[0015] The stimulation of the Trigeminal Cervical Complex (TCC) and the Vagus Nerve are aims to excite the sensory nerves, activating specific natural pain relief mechanisms. These mechanisms primarily include the Pain Gate Mechanism and the Endogenous Opioid System.

[0016] The pain gate mechanism involves activation (excitation) of the A beta (Ap) sensory fibres, which reduces the transmission of the noxious painful stimulus from the ‘C’ fibres, through the spinal cord to higher brain centres. This mechanism provides pain relief by essentially "closing the gate" to pain signals. Ap are mainly activated using high frequencies of stimulation, typically 90-120Hz.

[0017] The opioid system mechanism involves stimulating the A delta (Ab) fibres which respond better to lower frequencies. These stimulations activate opioid mechanisms, leading to the release of endogenous opiates (E.G., enkephalins, endorphins) in the spinal cord that inhibits the transmission of noxious sensory signals. Ab fibres are stimulated at a lower frequency, typically 2-10Hz.

[0018] Burst mode stimulation combines the activation of both Ap and Ab fibres, offering a dual approach to pain relief. In this instance, the higher frequency stimulation output (typically at about 100Hz) is interrupted (or burst) at the rate of about 2 - 3 bursts per second. When the machine is ‘on’, it will deliver pulses at the 100Hz rate, thereby activating the Ap fibres and the pain gate mechanism, but by virtue of the rate of the burst, each burst will produce excitation in the Ab fibres, therefore stimulating the opioid mechanisms.

[0019] In addition, is well known that the vagus nerve regulates pro-inflammatory cytokine levels. Thus, it is hypothesized that the stimulation of the vagus nerve could reduce inflammation and, thus, the pain perception. Moreover, there is preclinical and clinical evidence that vagus nerve modulates the release of monoamine neurotransmitters, influencing pain thresholds and emotional state.

[0020] Stimulators from the state of the art are often limited in their performance capability and efficacy. There are no devices capable of stimulating all three nerves of the trigeminal- cervical nervous complex and the vagus nerve at the same time. Frequently, these stimulators deliver stimulation of only one nerve using exclusively one type of stimulation, mainly electrical or magnetic stimulation. Thus, the efficacy to treat pain disorders using non-invasive stimulation devices is limited. Furthermore, current Transcranial Magnetic Stimulation (TMS) are designed to stimulate deep brain areas, so the pulse should trespass the head and the skull to activate the brain. So, these devices are bulky because they need high energy sources.

[0021] In addition, known devices are only able to stimulate either the peripheral orbitofrontal branches of the trigeminal nerve, or vagus nerve, using exclusively electrical stimulation. In the case to stimulate more than 1 nerve simultaneously, only the occipital nerves and branches of the trigeminal nerves are to be stimulated. On the other hand, know non- invasive magnetic stimulators activates only the occipital nerves. Moreover, these occipital stimulators, deliver stimulation in all the occipital nerves without isolated stimulation of the Greater and Lesser nerves.

[0022] It is therefore necessary to find a new stimulation device with which the above-described drawbacks of the known systems are completely overcome or at least greatly reduced.

[0023] Summary of the invention

[0024] According to the present invention, the objectives set forth herein are achieved by the elements of the independent claim. Other advantageous embodiments also emerge from the dependent claims and the description.

[0025] In particular, the objects of the present invention are achieved by a headset for the stimulation of the trigeminocervical complex of a human being comprising at least a first, a second and a third stimulator system, said stimulator systems being arranged on the headset such that a stimulation of the Greater and Leser Occipital Nerves, the auriculotemporal and the trigeminal nerves of the trigeminocervical complex of said human being is enabled, wherein the first simulator system is arranged on the headset in such a way to stimulate the auriculotemporal nerves and orbitofrontal branches of the trigeminal nerve, wherein the second simulator system is arranged on the headset in such a way to stimulate the occipital nerves.

[0026] In addition, the stimulator system of the headset embeds a third bilateral (right and left) stimulator of the cervical branch of the vagus nerve. These stimulators are located over the sternocleidomastoid muscles of the front neck delivering one of the 3 possible stimulations (magnetic, electrical or mechanical). The stimulator systems of the headset of the present invention are uniquely arranged in such manner that a stimulation of all three major areas of the trigeminocervical complex, including the occipital nerves, as well as the orbitofrontal branches of the trigeminal nerve and branches of the auriculotemporal nerves of the trigeminal nerve is enabled. In addition, the system stimulates the cervical branch of the vagus nerve.

[0027] The use of multimodal stimulation, activating the Trigeminal Cervical System and the Vagus Nerve at the same time, produce a more efficient block of the nerve pain signal conduction to the brain, as well as increase the delivery of analgesic and antiinflammatory neurotransmissions.

[0028] In one preferred embodiment of the present invention the first electrical stimulator is a system composed of two elements. First, a temple-shaped stimulator with at least 5 electrodes around each ear to stimulate the Auriculotemporal Nerves. Secondly, a bilateral system located in the forehead, which embeds 2 electrodes in each side above the eyes, to stimulate the orbitofrontal branches of the trigeminal nerves.

[0029] The second stimulator is a back headband located in the occipital protuberance of the skull which embeds at least 2 circular or helical coils to generate a magnetic field to stimulate the Greater and Lesser Occipital nerves. Optionally, the magnetic headband can be substituted for another headband which embeds flexible electrodes to deliver electrical stimulation, or a piezoelectric system to produce mechanical stimulation. This stimulator has a thermal sensor as a safety system to avoid overheating of the occipital area which stops the stimulation in the case to reach a specific temperature.

[0030] In addition to the first headband, a second headband located in the back neck muscle with piezoelectric and an electrical resistance could be added to produce a relaxation of the muscle of the neck.

[0031] In still another preferred embodiment the third stimulator is a bilateral system prolonged through the sternocleidomastoid muscle which embeds at least 1 circular or helicoid coil per site (left and right), to produce a magnetic field reaching the cervical branch of the vagus nerve.

[0032] Optionally, the magnetic stimulator could be replaced for mechanical (using a piezoelectric system) or an electrical (using flexible electrodes) stimulator. The present invention relates to a headset comprising a bilateral and multimodal stimulator system for the non-invasive isolated or simultaneous stimulation of the Trigeminal Cervical Complex (TCC) and the Vagus Nerve. This electrical, magnetic, thermal and mechanical stimulation of the occipital nerves, the auriculotemporal nerves, the orbitofrontal branches of the trigeminal nerve, and the vagus nerve, may be used for the treatment, prevention or prophylaxis of neurological disorders or pathologies like e.g., headache, migraine, or chronic pain. Further, it may be used for the treatment of different mental conditions such as anxiety and depression, among others.

[0033] The present invention provides several improvements and advantages compared to stimulators of the prior art: The stimulator systems of the headset of the present invention are uniquely arranged in such manner that an individual or simultaneous multimodal stimulation i.e., electrical, magnetic and mechanical, al stimulation of all three major areas of the trigeminocervical complex as well as the Vagus Nerve is enabled.

[0034] The headset stimulator systems are arranged such on the headset that a first stimulator system is positioned at least partially around the ears and on the forehead. The second stimulator is located at the back of the neck-scalp region to deliver magnetic, or electrical stimulation. Additionally at the lower back of the skull, on the neck muscles, a mechanical (ultrasound or vibratory using a piezoelectrical device) or thermal stimulator using an electrical resistance could be added.

[0035] In addition, the third stimulator is a bilateral multimodal (magnetic, electrical or mechanical) stimulator of the cervical branch of the vagus nerve.

[0036] In this way, the trigeminal orbitofrontal branches are stimulated with 2 electrodes per side, to optimize the activation of the trigeminal nerve. These electrodes are in two mobile rails (one per side, left and right) to adapt the position of the electrodes to the head of each patient.

[0037] The auriculotemporal nerves are stimulated with 5 electrodes per side, to maximize the activation of the auricular nerves.

[0038] The upper occipital stimulator could use several types of stimulation to produce a high activation of the occipital nerves to block pain perception. Our invention, because it modulates the physiology of most of the nerves involves in the process in the development of hypersensitivity, as well as the spread and referral of pain, improve the current state of the art.

[0039] In addition, this stimulator embeds a thermometer to avoid overheating to stop the magnetic stimulation when the temperature reaches a certain level. The coils, electrodes or piezoelectric are embed in a mobile rail to adapt the position of the electrodes to the back head of each patient.

[0040] Optionally, the occipital stimulator could include a lower headband to deliver vibration and heat to the neck muscle to reduce the tension of these muscle which is responsible to several pain disorders such as tension headaches.

[0041] In addition, this invention includes a wearable peripheral magnetic stimulator able to deliver both repetitive pulsed magnetic stimulation what promoting long-lasting therapeutical effects.

[0042] This invention, because it is designed to stimulate peripheral nerves, need a much lower power energy being feasible to embed the power generator in a wearable device.

[0043] Brief description of the drawings

[0044] To complete the description and in order to provide for a better understanding of the invention, a set of drawings is provided. Said drawings form an integral part of the description and illustrate preferred embodiments of the invention, which should not be interpreted as restricting the scope of the invention, but just as an example of how the invention can be embodied.

[0045] The drawings comprise the following figures:

[0046] Fig. 1 is a rear perspective view illustrating the headset according to claim 1 of the present invention.

[0047] Fig. 2 is a perspective view illustrating the headset according to claim 2 of the present invention, showing the bilateral system to stimulate the supraorbital branch of the trigeminal nerve and the auriculotemporal nerves. Fig. 3 is a detailed view of the orbitofrontal stimulation system, with 2 electrodes per side located in two mobile rails to adapt the position of the electrodes to the head of each patient.

[0048] Fig. 4a is a front perspective view illustrating the magnetic stimulator for the occipital nerves.

[0049] Fig. 4b is a rear perspective illustrating the magnetic stimulator for the occipital nerves.

[0050] Fig. 5a is a detailed view illustrating the coils housed inside the magnetic stimulator, according to claim 3 of the present invention.

[0051] Fig. 5b is a detailed view illustrating the temperature sensor, according to claim 4 of the present invention.

[0052] Fig. 6 is a perspective view illustrating the electrical and mechanical modules to stimulate the occipital nerves according to the description of the present invention.

[0053] Fig. 7 is a detailed view of the electrical stimulation module according to claim 6 of the present invention.

[0054] Fig. 8 is a detailed view of the mechanical stimulation module according to claim 5 of the present invention.

[0055] Fig. 9 is a detailed view of the heater, and a vibratory system located at the bottom of the mechanical stimulator

[0056] Fig. 10 is a detailed view of the auriculotemporal electrodes, arranged on the first templeshaped component of the headset according to one preferred embodiment of the present invention.

[0057] Fig. 11 is a perspective view of the headset connection between the cervical stimulation modules and the first and second stimulation systems. Fig. 12a and fig. 12b are a detailed view of the connection between the electronic generator and the cervical stimulation modules via USB-C

[0058] Fig. 13 is a perspective view of the headset configuration with occipital and cervical magnetic stimulation.

[0059] Fig. 14 is a perspective view of the headset configuration with occipital magnetic and cervical electrical stimulation.

[0060] Fig. 15 is a perspective view of the headset configuration with occipital magnetic and cervical electrical stimulation.

[0061] Fig. 16 is a perspective view of the headset configuration with occipital and cervical electrical stimulation.

[0062] Fig. 17 is a perspective view of the headset configuration with occipital and cervical mechanical stimulation.

[0063] Detailed description of the invention

[0064] Fig. 1 is a perspective view of an embodiment of the headset according to one embodiment of the present invention comprising a first (1), a second (2) and a third (3) stimulator system.

[0065] Fig. 2 shows the first stimulator system (1 ), that has two different stimulation areas. First of them is arranged on a first (1.1) and a second (1.2) temple-shaped with at least 5 electrodes (12.1 , 12.2, 12.3, 12.4, 12.5) around each ear to stimulate the Auriculotemporal Nerves. Also incorporate a PPG sensor (13). This sensor is a critical component that can accurately monitor the wearer's cardiac variability in real-time to provide a personalized treatment for the stimulation.

[0066] Secondly, a bilateral system located in the forehead (14), which embeds 2 electrodes (15.1 , 15.2) in each side above the eyes, to stimulate the orbitofrontal branches of the trigeminal nerves. Electrodes are embebed into two rails located in the sides of the forehead (Fig.3). This type of stimulation ensures the highest efficiency on stimulating the areas with the greatest density of nerve fibers because of the rails, that customize the placement of the electrodes to match the user's anatomy, offer a snug fit while adhering to a standardized design.

[0067] The sides of the device, shaped like identical temples, are carefully designed to offer a comfortable and secure fit when placed on the back of both ears. This unique configuration not only ensures stability and precise electrical stimulation of the auriculotemporal nerves but a snug and unobtrusive fit for all kinds of users.

[0068] Second stimulator is a back headband (2) located in the occipital protuberance of the skull (Fig. 4a and 4b) which embeds, at least, 2 circular or helical coils (25.1 , 25.2) to generate a magnetic field to stimulate the Greater and Lesser Occipital nerves (Fig. 5a).

[0069] This second stimulator is connected to the first and has an adjustable thread system to adapt to the different head sizes of the people who use it and incorporates a thermal sensor (21) as a safety system, to avoid overheating of the occipital area which stops the stimulation in the case to reach a specific temperature (Fig 5b).

[0070] Optionally, the magnetic headband can be substituted for another headband which embeds flexible electrodes (22) to deliver electrical stimulation, or a piezoelectric system to produce mechanical stimulation (23) (Fig.6)

[0071] This stimulator also incorporates a thermal sensor (21) similar to the magnetic stimulator.

[0072] In this case, the upper headband (Fig. 7) stimulates both the greater and lesser occipital nerves electrically. The pair of electrodes (26.1 , 26.2) positioned on the skull are constructed with conductive polymer materials, providing both flexibility and a secure attachment to the skin. This design ensures effective electrical stimulation at a specific voltage.

[0073] The second one (23) is located over the suboccipital musculature in the neck-scalp regions. The set in charge of stimulating over the muscle possesses two areas of piezoelectric materials that generate a series of mechanical waves that act over the major occipital nerves, saturating the nerve fibers and preventing the signalling of painful stimuli (As described in the Gate Theory). The piezoelectric pieces (27.1 , 27.2) are located over a rail too, this allows a better placement of the device for the user. This piece is also equipped with a thermometer to ensure that the tissues don't overheat from the vibration (Fig 8).

[0074] Both pieces can be customized to fit the user's dimensions through the threaded mechanism located on the back of each piece. This threaded adjustment allows for precise and secure fitting when tightened.

[0075] Fig. 9 shows a detail of the thermal stimulator (24), incorporated into the mechanical stimulator headband.

[0076] Fig 10 is a detailed view of the auriculotemporal electrodes (12.1 , 12.2, 12.3, 12.4, 12.5) of the stimulator system (1) arranged on the first temple-shaped component (11). In addition, the arrangement of a sensor (13), e.g., a photoplethysmogram sensor, can be seen.

[0077] Third stimulator (3) is a bilateral system prolonged through the sternocleidomastoid muscle which embeds, in one of the embodiments, at least 1 circular or helicoid coil per site (left and right), to produce a magnetic field reaching the cervical branch of the vagus nerve. (Fig 11).

[0078] It’s a modular system, being able to connect the necessary element depending on the type of stimulation desired (magnetic (31.1 , 31.2), electrical (32.1 , 32.2) or mechanical (33.1 , 33.2) through its USB-C connection (34.1 , 34.2) as can be seen in figures 12a and 12b.

[0079] Thanks to its modularity, various combinations arise that allow the type of stimulation desired to be personalized and improve the effectiveness of the treatment depending on the patient's needs.

[0080] Fig. 13 shows the Trigeminal Auriculotemporal Occipital Stimulator in its electrical stimulation configuration for the trigeminal area (1.1 , 1.2) and magnetic stimulation in the occipital area (21 ) and the vertical branch of the vagus nerve (31.1 , 31 .2)

[0081] Changing the magnetic stimulation item for the electric one (Fig.14), a different effect is achieved. Electrical stimulation configuration for the trigeminal area (1.1 , 1.2) magnetic stimulation in the occipital area (21) and electrical stimulation for the vertical branch of the vagus nerve (32.1 , 32.2).

[0082] Along the same lines, Figure 15 shows a TAOS configuration similar to the previous ones except for mechanical ultrasound (33.1 , 33.2) stimulation in the cervical branch of the vagus nerve.

[0083] Figures 16 and 17 show different combinations of electrical and mechanical stimulation for the occipital and cervical areas.

[0084] In the following claims the word "comprising" does not exclude other elements or steps, and the indefinite article "a" or "an" does not exclude a plurality. A single unit or step may fulfil the functions of several features recited in the claims. The mere fact that certain measures are recited in mutually different dependent claims does not indicate that a combination of these measures cannot be used to advantage. The terms “essentially”, “about”, “approximately” and the like in connection with an attribute or a value particularly also define exactly the attribute or exactly the value, respectively. Any reference signs in the claims should not be construed as limiting the scope.

Claims

CLAIMS1. A headset system for the bilateral and simultaneous stimulation of 4 nerves: 1) occipital nerves; 2) supraorbital branch of the trigeminal nerve; 3) auriculotemporal nerves and; 4) vagus nerve.

2. The headset in accordance with Claim 1 , wherein a bilateral temple-shaped and forehead arm for the simultaneous electrical stimulation of the supraorbital branch of the trigeminal nerve and the auriculotemporal nerves.

3. The headset in accordance with Claim 1 , wherein a magnetic stimulator using repetitive peripheral magnetic stimulation (rPMS), is in the back of the head to stimulate occipital nerves.

4. The magnetic stimulator, in accordance with Claim 3, embeds a temperature sensor as a safety system.

5. The headset in accordance with Claim 1 , wherein a mechanical stimulator is in the back of the head to stimulate occipital nerves, using a piezoelectric device.

6. The headset in accordance with Claim 1 , wherein an electrical stimulator is in the back of the head using polymer flexible electrodes.

7. The headset in accordance with Claim 1 , wherein a heater and a vibratory system is in the neck muscle.

8. The headset in accordance with Claim 1 , wherein a magnetic stimulator using repetitive peripheral magnetic stimulation (rPMS), is in the neck over the sternocleidomastoid to stimulate the cervical branch of the vagus nerve.

9. The headset in accordance with Claim 1 , wherein an electrical stimulator is in the neck over the sternocleidomastoid to stimulate the cervical branch of the vagus nerve.

10. The headset in accordance with Claim 1 , wherein a mechanical stimulator is in the neck over the sternocleidomastoid to stimulate the cervical branch of the vagus nerve.

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