Wearable auricular nerve stimulator and method of use

Abstract

In an exemplary embodiment, the wearable auricular stimulator includes a flexible body adapted to be at least partially fitted around the wearer's auricle, the flexible body having an exterior for contacting and positioning with the wearer's skin and an interior for supporting a three-dimensional (3D) circuit layout; a three-dimensional (3D) circuit layout having a three-dimensional (3D) circuit layout having wiring mounted on the interior surface of the flexible body and electrodes for delivering electrical stimulation therapy to the wearer via the skin-facing side of the flexible body; and electronic components(s) electrically connected to the electrodes and wiring, the electronic components including processing circuit elements for delivering electrical stimulation therapy(s) via the electrodes.

Description

Technical Field

[0003] , ,

[0001] Related Applications This application is a continuation of U.S. Patent Application No. 18 / 675,492, filed on May 28, 2024, entitled "Wearable Auricular Neurostimulator and Methods of Use", and claims priority thereto. The specification of the 18 / 675,492 application is a continuation of U.S. Patent Application No. 18 / 209,852, filed on June 14, 2023, entitled "Wearable Auricular Neurostimulator and Methods of Use", and claims priority thereto.

Background Art

[0002] Non-invasive, easy-to-use, and / or accessible therapies are the goal of new non-drug treatments. The main examples of these treatments are wearable medical devices. The main purpose of medical devices is to be safe and effective, but the goal of any wearable medical device is comfort, ease of use, and aesthetics. Aligning these two sets of goals is often difficult.

[0003] Devices for stimulating nerve structures above and around a patient's ear have been designed to provide stimulation by puncturing or without puncturing the dermis above or around the ear. Non-puncture electrodes may be held frictionally and / or adhesively in contact with the skin above and around the patient's ear to target various nerve structures. Non-puncture electrodes may have a considerably larger surface area compared to systems that rely on dermal puncture electrodes, so that multiple nerve endings are stimulated by a single electrode during therapy. Some nerve endings may be located in close proximity directly beneath and / or below the skin where the non-puncture electrode is placed. By targeting multiple nerve endings, the positioning of each electrode does not necessarily need to be precise. Therefore, for example, the patient or caregiver can put the device on or take it off as desired / as needed (e.g., for sleep, showering, etc.). Furthermore, targeting multiple nerve endings is advantageous because stimulating multiple nerve branches elicits a stronger response than stimulating a single branch in cases where pinpoint electrodes such as needle electrodes are used. Such devices are described, for example, in U.S. Patent No. 10,695,568, entitled "Device and Method for the Treatment of Substance Use Disorders," and in U.S. Patent No. 11,623,088, entitled "Devices and Methods for the Treatment of Substance Use Disorders," each of which is incorporated herein by reference in whole.

[0004] Transcutaneous stimulation of these nerve regions enables a variety of beneficial treatments. In some cases, these include the treatment of acute or chronic pain, inflammatory diseases, and cognitive impairment. For example, the nucleus tractus solitarius (NTS) receives afferent connections from many regions, including the trigeminal cervical complex (TCC) and the cervical vagus nerve, as well as from the auricular branch (ABVN) of the vagus nerve. The TCC is a region in the cervical and brainstem areas where synapses of trigeminal and occipital nerve fibers, including the auriculotemporal nerve (ATN), lesser occipital nerve, and greater auricular nerve, are formed. The TCC projects to several regions of the brainstem, including, but not limited to, the greater raphe nucleus (NRM) and other parts of the raphe nuclei (in this specification, all specific raphe nuclei are referred to as raphe nuclei (RN)), locus coeruleus (LC), periaqueductal gray nucleus (PAG), nucleus basal ganglia of Meynert (NBM), nucleus ambiguus (NA), ventral tegmental area (VTA), nucleus accumbens (NAc), ntonic septum (NTS), and parapontine nuclei (PbN). In particular, the NTS also projects to higher brain functions such as the RN (e.g., NRM), LC, and PAG, as well as the hypothalamus, and incorporates into the arcuate nucleus (ARC), which receives afferent input from the NTS, the majority of which is from the non-hypothalamic region. Furthermore, many interconnections exist between different brainstem nuclei (e.g., PAG, LC, RN, NRM, NBM, PbN, PPN, NA, VTA, NAc). For example, LC, PAG, and RN (e.g., NRM) project to NA, and PPN projects to VTA. VTA then projects to the prefrontal cortex, interconnecting with the hypothalamus and hippocampus. VTA also projects directly to the hippocampus. The hippocampus then projects to NAc, which interconnects with the hypothalamus.

[0005] There are descending indirect connections leading to the heart, lungs, intestines, and spleen. Indirect connections include those where at least one synapse is located elsewhere before reaching the target. This means that modulating the activity of these neural circuits can affect the respective organs. For example, it is possible to regulate heart rate (e.g., decrease heart rate or increase heart rate variability), increase oxygen absorption in the lungs by increasing bronchial tissue compliance and thus increasing the potential for oxygen transport, thus increasing the likelihood that more oxygen will be absorbed into the blood, increase intestinal motility by a descending pathway originating from the dorsal motor nucleus (DMV) of the vagus nerve, and since DMV activity is regulated by NTS activity, intestinal motility can be influenced by modulating NTS activity, and a reduction in circulating pro-inflammatory cytokines can be achieved by modulating splenic activity via the NTS descending pathway. For examples of increased bronchial compliance and reduced inflammation, see U.S. Patent No. 10,967,182, entitled "Devices and Methods for Reducing Inflammation Using Electrical Stimulation," which is incorporated herein by reference in its entirety. Furthermore, by regulating splenic activity, platelet function can be enhanced, enabling faster and more effective coagulation, which may occur even in the presence of coagulation factor deficiencies (e.g., hemophilia A, B, and C, factor I, factor II, factor V, factor VII, factor X, factor XII, factor XIII deficiencies) and / or other coagulation disorders (e.g., von Willebrand disease (VWD)).

[0006] Heart rate variability (HRV) is a reflection of the state of the autonomic nervous system (ANS). In stressful situations, the sympathetic branches of the ANS, which are more active, tend to increase heart rate (HR) and decrease HRV, while the parasympathetic branches of the ANS tend to decrease HR and increase HRV. Low HRV is associated with morbidity and mortality in several diseases, while high HRV is associated with well-being; therefore, HRV has been used as a health biomarker. For an example of treating stress, see U.S. Patent Application Publication 2023 / 0149703, entitled "Devices and Methods for Treating Stress and Improving Alertness Using Electrical Stimulation," which is incorporated in its entirety herein by reference.

[0007] There are at least three distinct opioid receptors, Mu(μ), Delta(δ), and Kappa(κ), which can, among other things, modulate pain and directly and indirectly regulate the production of important neuromodulators such as dopamine (DA), norepinephrine (NE), serotonin (5-HT), and acetylcholine (Ach). The body produces endogenous agonist peptides for each of these three opioid receptors. These peptides are called endorphins, which primarily bind to the Mu(μ) receptor; enkephalins, which primarily bind to the Delta(δ) receptor and less to the Mu(μ) receptor; and dynorphins, which primarily bind to the Kappa(κ) receptor. Pain research suggests that the central production of these endogenous peptides follows different pathways. Enkephalin production is more distributed, while endorphin production is mainly mediated by the activity of the arcuate nucleus (ARC) in the hypothalamus, and parapontine nucleus activity greatly influences dynorphin production. Neurostimulation therapy for pain regulation may be performed to reduce or alleviate chronic pain, recurrent pain, and / or acute pain. For example, the devices described herein may be used to treat chronic low back pain, headaches, migraines, cluster headaches, pain due to temporomandibular joint disorders (TMD), pain due to endometriosis, menstrual cramps, and / or spasms (e.g., menstrual cramps, endometriosis, etc.).

[0008] Transcutaneous stimulation therapy devices can be used to induce neuronal plasticity or neural plasticity to improve cognitive function, recover from stroke, treat post-traumatic stress disorder (PTSD), phobias, attention deficit / hyperactivity disorder (ADHD), attention deficit disorder (ADD), and dementia, including Alzheimer's disease. Since neural plasticity is fundamental to learning, strategies that enhance neural plasticity during training can significantly accelerate the rate of learning. Previous research has successfully demonstrated that invasive or implantable vagus nerve (VNS) stimulation can promote robust and specific neural plasticity. Short bursts of VNS stimulation, when combined with training, activate plasticity-promoting neural modal circuits, strengthening specific neural networks involved in learning. This can be achieved non-invasively, for example, via ABVN stimulation, and indirectly via ATN stimulation. This precise control of neural plasticity, coupled with the flexibility to pair with virtually any training paradigm, establishes stimulation of any of these neurons as a promising targeted neural plasticity training paradigm. For an example of the treatment of cognitive impairment, see U.S. Patent No. 11,351,370, entitled “Devices and Methods for Treating Cognitive Dysfunction and Depression Using Electrical Stimulation,” which is incorporated herein by reference in its entirety. Another example is training to restore function after a stroke, which can be done with or without feedback. When feedback is used, it is usually in the form of a trigger mechanism. In some examples, the trigger mechanism may be, among other things, the person / trainer observing the person being trained, or a sensor, such as a motion sensor, accelerometer, EEG, EKG, or EMG sensor.

[0009] The vagus nerve is one of the longest cranial nerves and can be located adjacent to the carotid artery in the neck along its trajectory (i.e., the cervical vagus nerve). Direct stimulation of the vagus nerve activates the nucleus tractus solitarius (NTS), which projects to the nucleus basal ganglia (NBM) and locus coeruleus (LC). The NBM and LC are deep brain structures that release acetylcholine and norepinephrine, respectively, which are plasticity-promoting neurotransmitters important for learning and memory. Vagus nerve stimulation using chronically implanted electrode cuffs has been safely used in humans to treat epilepsy and depression and has shown success in clinical trials for tinnitus and motor dysfunction after stroke. For an example of treating depression, see U.S. Patent No. 11,351,370, entitled "Devices and Methods for Treating Cognitive Dysfunction and Depression Using Electrical Stimulation."

[0010] The ABVN ascends adjacent to the external auditory canal and emerges to the surface via the mastoid tubule (MsC, also known as Arnold's canal), supplying several dermatome regions of the external ear, such as the concha and the tragus. Non-invasive stimulation of the ABVN can stimulate activity in similar brain regions as invasive vagus nerve stimulation. Recently, auricular nerve stimulation has been shown to be beneficial in the treatment of several human diseases.

[0011] Therapeutic devices may be designed to provide transcutaneous stimulation therapy to treat the same diseases treated with implantable and transcutaneous devices. Transcutaneous stimulation therapy may be designed to restore autonomic nervous system balance impaired by diseases such as heart failure, atrial fibrillation (AF), anxiety, stress, post-traumatic stress disorder (PTSD), gastric motility, depression, cluster headaches, migraines, inflammation, and autoimmune diseases. Furthermore, these devices may be designed to accelerate coagulation and stop bleeding more quickly to help with chronic diseases such as coagulation disorders, and cyclical diseases such as cases of periodic severe bleeding such as menorrhagia and / or heavy menstrual bleeding, as well as to minimize bleeding in acute scenarios such as bleeding after a traumatic event, or in surgical and postoperative scenarios. Transcutaneous electrical stimulation of the tragus (e.g., the anterior prominence of the outer ear), which is partially innervated by the auricular branch of the vagus nerve, can induce evoked potentials in the brainstem of human subjects. Based on these observations, it was demonstrated that percutaneous low-level VNS stimulation achieved by stimulating the auricular branch of the vagus nerve in the tragus suppressed the likelihood of inducing atrial fibrillation. Non-invasive percutaneous low-level VNS stimulation increases the AF threshold (reducing the risk of AF) and reduces AF load in mammals, including humans. In healthy subjects, percutaneous low-level VNS stimulation can also effectively restore parasympathetic / sympathetic balance by increasing heart rate variability, increasing parasympathetic tone, and / or decreasing sympathetic outflow.

[0012] Transcutaneous stimulation therapy devices can be used to reduce inflammation caused by viral or bacterial infections, as well as other reasons. In the early stages of infection, the body's response includes the secretion of pro-inflammatory cytokines. In some cases, controlling this inflammatory response can help the body heal more quickly. The inflammatory response is a double-edged sword in the sense that it is necessary to eradicate cells infected with viruses and bacteria. However, an excessive pro-inflammatory response can actually be fatal. In respiratory infections in particular, pro-inflammatory cytokines can lead to increased pathogen replication. Furthermore, lung function can be impaired by the accumulation of pro-inflammatory cytokines. Studies suggest that the pro-inflammatory response is often excessive in some people (e.g., the elderly). In many of these cases, this pro-inflammatory response causes more harm than the infection itself, potentially leading to death in the infected subject. For example, the human body exhibits an excessive pro-inflammatory response in response to coronavirus disease 2019 (COVID-19) and severe acute respiratory syndrome (SARS). In fact, the evidence gathered so far suggests that in some severe COVID-19 patients, the body responds by intensifying the release of pro-inflammatory cytokines. Reducing the inflammatory response by, for example, decreasing circulating pro-inflammatory cytokines may, in some cases, shorten the time to recovery and / or shorten the time an infected person may need assisted breathing therapy, such as requiring a ventilator. Generally, patients are connected to a ventilator for less than 5 days on average, but in the case of COVID-19, patients continue to use a ventilator three or four times longer, i.e., 15 to 20 days. Medical centers generally have enough ventilators to accommodate patients who require a ventilator for less than 5 days on average. The increased time required for ventilators in COVID-19 patients is a contributing factor to the overall mortality seen in COVID-19, because many patients who require ventilators do not have access to them.The therapeutic devices and methods described herein can, through modulation of NTS activity, a) increase bronchial tissue compliance, ultimately delivering more oxygen to the body, and b) alleviate inflammation by reducing circulating pro-inflammatory cytokines in the body, including the lungs. These two effects make it possible for the novel therapeutic devices and methods described herein to act as adjunctive therapies in the treatment of respiratory infections (e.g., Middle East Respiratory Syndrome Coronavirus (MERS), Severe Acute Respiratory Syndrome (SARS), COVID-19, or Chronic Obstructive Pulmonary Disease (COPD)).

[0013] Bronchial compliance is generated by the regulation of autonomic lung pathways. In particular, the novel therapies presented herein stimulate the ABVN and / or auricular-temporal nerve (ATN), which project to the NTS. The NTS projects to the LC, PAG, and RN (e.g., NRM). These brainstem nuclei deliver inhibitory signals to airway-related preganglionic neurons located in the nucleus ambiguus (NA). The NA signals airway smooth muscle, primarily via efferent pathways through the vagus nerve, inducing bronchiectasis.

[0014] The anti-inflammatory effect is provided through the activation of anti-inflammatory pathways (also known as cholinergic anti-inflammatory pathways). In particular, the novel therapies described herein stimulate the ABVN and / or ATN, which have projections to the NTS as previously stated, and these projections induce cholinergic anti-inflammatory effects via efferent pathways, primarily via the vagus nerve. Systemic anti-inflammatory responses may also be used to treat and / or prevent sepsis, one of the most costly and often fatal diseases. Another inflammatory disease that can be treated via a systemic anti-inflammatory response is pancreatitis. Pancreatitis is acute or chronic inflammation of the pancreas, which can be caused by a variety of factors. Systemic anti-inflammatory effects occur when the vagus nerve modulates splenic function, thereby reducing the amount of circulating pro-inflammatory cytokines. In addition, local anti-inflammatory effects occur in organs reached by efferent pathways, such as the lungs, intestines, and heart. Furthermore, platelet modification through the regulation of spleen activity leads to faster coagulation, even in the presence of coagulation disorders such as hemophilia A, B, and C, as well as in other coagulation factor deficiencies, such as factor I, factor II, factor V, factor VII, factor X, factor XII, and factor XIII deficiencies, and similarly in cases where other coagulation disorders such as vellus disease (VWD) are present.

[0015] For the reasons stated above, the rapid production of effective, low-cost transcutaneous nerve stimulation devices can bring significant medical benefits to a wide range of people. The inventors recognized the need to develop new manufacturing techniques and stimulus delivery mechanisms to improve usability, thereby increasing therapy compliance, reducing manufacturing costs, and increasing production volume, thereby enabling broader access to symptom relief and / or improvement of conditions in patients exhibiting the various disorders detailed above, as well as additional disorders and diseases for which transcutaneous nerve stimulation therapy may be beneficial. [Prior art documents] [Patent Documents]

[0016] [Patent Document 1] U.S. Patent No. 10695568 [Patent Document 2] U.S. Patent No. 11623088 [Patent Document 3] U.S. Patent No. 10967182 [Patent Document 4] U.S. Patent Application Publication No. 2023 / 0149703 [Patent Document 5] U.S. Patent No. 11351370 [Overview of the project] [Means for solving the problem]

[0017] The inventors recognized the need to pursue seamless integration of medical devices and wearable devices into desired form factors. They achieved this integration by using the flexible wearable body of the wearable medical device as the substrate for the printed circuit board (PC), realizing a three-dimensional (3D) circuit that integrates the electronic components of the auricular electroneuromodulator into the geometric shape of the wearable device. This offers several advantages over commonly used methods of integrating electronic and mechanical components. In commonly used methods, rigid, flexible, or rigidflex printed circuit boards (PCBs) are miniaturized as much as possible and then inserted into a housing, which may be the wearable device itself. The interconnection between the PCB and the wearable device is one of the most common points of failure, and therefore they are usually made very robust, thereby increasing cost, weight, and size. Furthermore, user interfaces, such as buttons or LEDs, typically need to be close to the outer surface of the wearable device or coplanar with the wearable device. This is usually achieved by using additional components such as light pipes and connecting rods that run from the circuit to the surface. In many cases, even with such connectors, the PCB layout is determined by the desired position of user interface components determined by the mounted device, and the best position for such components rarely aligns with what is already on the PCB. Therefore, the position of user interface components imposes limitations on the PCB layout. Furthermore, since user interface components are typically the largest components on a circuit today, miniaturization of the PCB is severely limited. Moreover, even with flexible or rigid-flex PCBs, circuits can be bent, but they cannot be stretched. Each of the above limitations can be overcome by the embodiments described herein.

[0018] In one embodiment, the disclosure relates to design and manufacturing techniques for creating a wearable auricular nerve stimulator (WANS) having a three-dimensional (3D) electronic circuit with integrated electronic components including at least two electrode components for delivering nerve stimulation. The WANS may include at least one earpiece assembly portion manufactured using a flexible and / or stretchable material (e.g., plastic, rubber, silicone, polyethylene terephthalate (PET), thermoplastic polyurethane (TPU), nonwoven polypropylene, etc.). The earpiece assembly portion may be, for example, molded or three-dimensional printed. One of the earpiece assembly portions incorporates a desired topography on its surface area for positioning each of the electronic components of the three-dimensional circuit in the horizontal and / or vertical position most suitable for that electronic component. For example, a button component may have a topographic footprint positioned in close proximity to one of the surfaces of the molded portion. Wiring between electronic components may be printed using conductive ink that allows the printed substrate to bend and stretch, thereby connecting electronic components mounted at various topographic surface positions to the electronic circuit. In some implementations, a dielectric layer is placed over all wiring and / or electronic components. In some implementations, a second earpiece assembly portion is provided as a cover for sealing the WANS earpiece assembly. The cover may be molded, for example, using one or more flexible materials, or it may be 3D printed. In some embodiments, a more traditional PCB (e.g., a rigid-flex PCB) can be combined with printed 3D structured circuits to provide several advantages, such as manufacturing advantages.

[0019] In some embodiments, the WANS is configured to be powered by a primary battery, such as a coin cell battery. Using a primary battery may be preferable when designing a completely disposable WANS.

[0020] In some embodiments, the WANS has a rechargeable battery. The battery may be designed to recharge, for example, via electromagnetic induction. In another example, the rechargeable battery can be recharged via a temporarily connected cable.

[0021] In some embodiments, the WANS is fully sealed to prevent ingress of water and dust. The outer cover can provide, for example, a waterproof or water-resistant surface seal.

[0022] In one aspect, the present disclosure relates to a self - contained auricular neuromodulator configured to be disposed around a wearer's ear such that surface electrodes are positioned at locations that electrically stimulate one or more branches of the vagus nerve and / or trigeminal nerve to provide therapy to the wearer.

[0023] In some embodiments, the auricular electrical neuromodulator is configured to be disposed around the wearer's ear such that at least one of its electrode components (e.g., at least one vagus nerve stimulation electrode) is proximate to a branch of the vagus nerve. In one example, at least one vagus nerve stimulation electrode may be disposed at a position to stimulate the auricular branch of the vagus nerve (ABVN). The ABVN can be targeted, for example, by disposing one or more vagus nerve stimulation electrodes that contact the tragus of the wearer's ear. In another example, one or more vagus nerve stimulation electrodes may be disposed to contact the scapha of the wearer's ear. In a further example, one or more vagus nerve stimulation electrodes may be disposed to contact a portion of the skin behind the wearer's ear (e.g., auricular skin, head skin, or both), and the vagus nerve stimulation electrode is close to the mastoid canal (i.e., Arnold's canal) where the ABVN appears on the surface from the temporal bone. In an additional example, the ABVN can be targeted by disposing one or more vagus nerve stimulation electrodes to contact the posterior surface of the external auditory canal of the wearer's ear. In yet another example, since the ABVN has a branch connected to the posterior auricular nerve, the ABVN can be indirectly activated by stimulating the posterior auricular nerve. In this example, one or more vagus nerve stimulation electrodes can be disposed at a position to contact the skin behind the ear and / or the skin of the head disposed close to the posterior auricular nerve pathway.

[0024] In some embodiments, the auricular electrical neuromodulator is configured to be disposed around the wearer's ear such that at least one of its electrode components (e.g., trigeminal nerve stimulation electrode) is proximate to a branch of the auriculotemporal nerve (ATN). In one example, the ATN can be targeted by disposing one or more trigeminal nerve stimulation electrodes on the facial skin of the patient in front of the ear. By way of illustration, the facial skin may be disposed to cover or be close to the temporomandibular joint. In another example, the ATN can be targeted by disposing one or more trigeminal nerve stimulation electrodes to contact the anterior portion of the external auditory canal of the wearer's ear through which a branch of the ATN (e.g., the external auditory canal nerve) passes.

[0025] In some embodiments, the auricular electroneuromodulator is configured to be positioned around the wearer's ear such that at least one of its electrode components (e.g., an ABVN stimulating electrode) is positioned close to the site where ABVN surfaces via the MsC. Using different approaches, many researchers have targeted ABVN via the external auditory canal as well as the concha and internal tragus. However, modulating ABVN activity (directly or indirectly) when it surfaces via the MsC is a novel concept that offers significant utility and manufacturability advantages.

[0026] The above general description of exemplary implementations and the following detailed description are merely illustrative of the teachings of this disclosure and are not limiting.

[0027] The accompanying drawings incorporated herein and forming part thereof illustrate one or more embodiments, and these embodiments are described together with the description. The accompanying drawings are not necessarily drawn to scale. The dimensions of values ​​shown in the accompanying graphs and drawings are for illustrative purposes only and may or may not represent actual or preferred values ​​or dimensions. Where applicable, some or all features may not be illustrated to aid in the description of the underlying features. The drawings are as follows: [Brief explanation of the drawing]

[0028] [Figure 1] This is a block diagram of an exploded view of the components of an exemplary wearable auricular nerve stimulator (WANS). [Figure 2A] This figure shows exemplary three-dimensional topography, printed circuitry, and additional electronic devices for forming various components of an exemplary WANS device. [Figure 2B] This figure shows exemplary three-dimensional topography, printed circuitry, and additional electronic devices for forming various components of an exemplary WANS device. [Figure 2C] This figure shows exemplary three-dimensional topography, printed circuitry, and additional electronic devices for forming various components of an exemplary WANS device. [Figure 2D] This figure shows exemplary three-dimensional topography, printed circuitry, and additional electronic devices for forming various components of an exemplary WANS device. [Figure 2E] This figure shows exemplary three-dimensional topography, printed circuitry, and additional electronic devices for forming various components of an exemplary WANS device. [Figure 2F] This figure shows exemplary three-dimensional topography, printed circuitry, and additional electronic devices for forming various components of an exemplary WANS device. [Figure 2G] This figure shows exemplary three-dimensional topography, printed circuitry, and additional electronic devices for forming various components of an exemplary WANS device. [Figure 3] This figure shows an exemplary three-dimensional printed flexible circuit for a WANS device. [Figure 4] This figure shows an example of a cover for a WANS device. [Figure 5] This figure shows an exemplary adhesive area layout and protective liner positioning on the external skin-facing surface of the WANS device. [Figure 6] This is a diagram showing an exemplary assembled WANS device. [Figure 7A] This figure shows an exemplary method for manufacturing a WANS device having a three-dimensionally printed flexible circuit. [Figure 7B] This figure shows an exemplary method for manufacturing a WANS device having a three-dimensionally printed flexible circuit. [Figure 8A] This figure shows an exemplary target nerve region for directing therapy using a WANS device. [Figure 8B] This figure shows an exemplary target nerve region for directing therapy using a WANS device. [Figure 8C] This figure shows an exemplary target nerve region for directing therapy using a WANS device. [Figure 8D] This figure shows an exemplary target nerve region for directing therapy using a WANS device. [Figure 9] This figure shows an exemplary target nerve region for directing therapy using a WANS device. [Figure 10] This figure shows an exemplary target nerve region for directing therapy using a WANS device. [Figure 11] This figure shows an exemplary WANS device including two auricle units connected by a band. [Figure 12] This is a block diagram of the components of an exemplary pulse generator that communicates with an exemplary auricular therapy device. [Figure 13A] This figure shows a second example of a WANS device that has been assembled. [Figure 13B] Figure 13A shows the internal components of an exemplary WANS device. [Figure 14A] This is an exemplary cross-sectional view of a WANS (Wall-Aided Synthetic Component) illustrating the limited degrees of freedom of movement of an electronic component. [Figure 14B] This is an exemplary cross-sectional view of a WANS (Wall-Aided Synthetic Component) illustrating the limited degrees of freedom of movement of an electronic component. [Figure 14C] This is an exemplary cross-sectional view of a WANS (Wall-Aided Synthetic Component) illustrating the limited degrees of freedom of movement of an electronic component. [Figure 14D] This is an exemplary cross-sectional view of a WANS (Wall-Aided Synthetic Component) illustrating the limited degrees of freedom of movement of an electronic component. [Figure 15A] This is a detailed diagram showing some of the internal components of a second exemplary WANS device. [Figure 15B] This is a detailed diagram showing some of the internal components of a second exemplary WANS device. [Figure 15C] This is a detailed diagram showing some of the internal components of a second exemplary WANS device. [Modes for carrying out the invention]

[0029] The following description, in relation to the accompanying drawings, is intended to describe various exemplary embodiments of the disclosed subject matter. Specific features and functions are described in relation to each exemplary embodiment. However, it will be apparent to those skilled in the art that the disclosed embodiments may be carried out without each of those specific features and functions.

[0030] Throughout this specification, any reference to “one embodiment” or “one embodiment” means that a particular feature, structure, or characteristic described in relation to one embodiment is included in at least one embodiment of the disclosed subject matter. Therefore, occurrences of the phrase “in one embodiment” or “in one embodiment” in various places throughout this specification do not necessarily refer to the same embodiment. Furthermore, a particular feature, structure, or characteristic can be combined in any suitable manner in one or more embodiments. Moreover, embodiments of the disclosed subject matter are intended to encompass modifications and variations thereof.

[0031] It should be noted that, as used herein and in the appended claims, the singular forms “a,” “an,” and “the” include plural references unless the context clearly indicates otherwise. That is, unless otherwise explicitly stated, terms such as “a,” “an,” and “the” as used herein mean “one or more.” In addition, it should be understood that terms such as “left,” “right,” “up,” “down,” “front,” “back,” “side,” “height,” “length,” “width,” “upper side,” “lower side,” “inside,” “external,” “inside,” and “outside” as may be used herein merely describe reference points and do not necessarily limit embodiments of the disclosure to any particular orientation or configuration. Furthermore, terms such as “first,” “second,” and “third” merely identify one of several parts, components, steps, actions, functions, and / or reference points disclosed herein and similarly do not necessarily limit embodiments of the disclosure to any particular orientation or configuration.

[0032] Furthermore, the terms “approximately,” “about,” “approximate,” “small variation,” and similar terms typically refer to a range that includes, in a particular embodiment, identified values ​​within a margin of 20%, 10%, preferably 5%, and any values ​​in between.

[0033] All functions described in relation to one embodiment are intended to be applicable to the additional embodiments described below, unless explicitly stated otherwise or the feature or function is incompatible with the additional embodiment. For example, if a given feature or function is explicitly described in relation to one embodiment but not explicitly mentioned in relation to an alternative embodiment, it should be understood that the inventors intend that the feature or function may be developed, utilized, or implemented in relation to the alternative embodiment, unless the feature or function is incompatible with the alternative embodiment.

[0034] Figure 1 is a block diagram of an exploded view of the components of an exemplary wearable auricular nerve stimulator (WANS) 100 having an integrated three-dimensional printed circuit for advantageous positioning of circuit components in a compact and convenient arrangement. As shown, the WANS device 100 includes a body 102, a printed circuit 104 for mounting on the body 102, a set of electronic components 106 for adding to the printed circuit 104 at printed connection points, a cover 108 for enclosing the printed circuit 104 and electronic components 106 within the body 102, a conductive adhesive (e.g., a hydrogel or dry material such as FLEXcon® OMNI-WAVE® from FLEXcon Company, Inc., Spencer, Massachusetts) 110 configured to transfer energy from the WANS device 100 to the wearer's skin, a non-conductive adhesive (e.g., a hydrophilic colloid or dry skin adhesive) 112 for enhancing adhesion between the WANS device 100 and the wearer's skin, and one or more liners 114 for protecting the adhesive elements before attachment.

[0035] In some implementations, the body 102 is a flexible and / or stretchable wearable substrate designed to comfortably conform to the wearer's contours. The body 102 may be formed using, for example, rubber, plastic (e.g., PET, TPU, nonwoven polypropylene, etc.), and / or silicone. In some examples, the body 102 may be three-dimensionally printed and / or molded. The body 102 may be molded, for example, as a continuous molded product of a single material. In another example, the body 102 may be formed from two or more materials, for example, in a layered or two-step process. As shown in the figure, the body 102 includes a plurality of surface wells and protrusions to enable printing and / or positioning of the circuit 104 along the three-dimensional surface.

[0036] Referring to Figure 2A, the WANS-mounted main body portion 200 of the first example may be considered to include a front portion 202a, a rear portion 202b, and an ear rest portion 202c, each portion including at least one opening 204a-204c for electrodes. The WANS may be wrapped around the ear such that when the wearer puts it on, the front portion 202a is positioned in front of the ear and the rear portion 202b is positioned behind the ear. The ear rest portion 202c, connected to the front portion 202a by a flexible connector 206, may be held to the concha by friction and / or adhesive. In some embodiments, the ear rest portion 202c is formed of a different material from the front portion 202a and the rear portion 202b. For example, the ear rest portion 202c may be designed to exhibit different properties from the front portion 202a and the rear portion 202b, e.g., in some examples, deformability, adhesion, and / or different levels of flexibility.

[0037] In some implementations, one or more protrusions are formed within the material of the mountable body section 200. For example, the front portion 202a includes a pair of protrusions 208a-m. In another example, the rear portion 202b includes a protrusion 208n and a rounded wall mechanism 212. Most of the protrusions 208 are substantially rectangular or circular in shape, but in other embodiments, the protrusions may be formed in a variety of shapes. In some examples, specific protrusions may be provided for mounting or positioning certain circuit elements near the outer surface of the WANS device, which may be, for example, LEDs, control buttons, and / or sensors. For example, therapeutic electrodes are placed on the skin-facing surface of the WANS for convenience of use, while any control buttons may be positioned near a more accessible surface of the WANS. Some protrusions 208 may be formed, for example, as landing zones for pick-and-place circuit components. Some of the protrusions 208 may be partially formed to support the separation of the body section 200 from the corresponding cover or from other body sections, for example, to prevent circuit components from being crushed during use. At least some of the protrusions 208, for example, protrusions 208h and 208i, may be formed with inclined sides so that when circuit wiring is placed on them or flexible circuit wiring reaches the protrusions 208h and 208i, they do not form a 90-degree angle. The angle (e.g., up to 80°, up to 70°, about 45°, etc.) may be selected to place smooth electrical wiring and / or to increase the durability of the wiring (e.g., placed electrical wiring and / or flexible circuit wiring). Different protrusions 208 can be made using different materials and / or printed compositions to enhance the properties of the protrusions. For example, certain protrusions 208 may be designed to be substantially flexible (e.g., identical or similar to the flexibility of the body section 200), while other protrusions 208 may include reinforcing materials or components to increase rigidity. In some examples, protrusions designed to support heavier electronic components and / or to maintain separation between the body section 200 and the second body section or cover may be printed to increase rigidity.In certain cases, the protrusion may be mounted in an aspect ratio designed to support the electronic component at a desired height while substantially maintaining the position of the electronic component and / or without causing damage due to stress on the protrusion.

[0038] In some implementations, one or more wells are fabricated within the material of the wearable body section 200. The front section 202a includes, for example, a set of wells 210a-f. Certain wells 210 can provide positioning for electrical components, which in some examples are functional subunits such as capacitors, sensor components, power components, processing circuit components, memory components, and / or flex circuits, flex-rigid circuits, or rigid-flex circuits, which require additional vertical space between the body section and the corresponding cover or other body sections. In another example, several wells 210 can provide snag and / or precise positioning for electrical components. Furthermore, at least a portion of the wells 210 can provide positioning close to a region of interest. For example, wells 210 can be fabricated to position temperature sensors, acoustic sensors, electrocardiogram (ECG) sensors, and / or vibration sensors close to the skin for better collection of biometric data. In an additional example, at least a portion of the well 210 may provide a collection area for placing adhesive used to secure larger electronic components to the mounting body section 200. The electronic components may be placed on the adhesive area, for example, before printing three-dimensional circuit wiring.

[0039] In some implementations, the wearable body section 200 includes one or more port areas for connecting to circuits within the WANS. For example, the wearable body section 200 has a port 214 provided for electrically connecting external circuits (e.g., charging devices, control devices, one or more wired sensors, etc.) to the WANS. In other implementations, port 214 is provided to be used as a routing channel for wrapping 3D printed circuits to other areas of the WANS, such as external locations.

[0040] Returning to Figure 1, in some implementation configurations, the printed circuit 104 for mounting on the main body 102 is printed using conductive ink that allows the substrate on which the circuit wiring is printed to bend and stretch, thereby connecting electronic components 106 mounted at various topographic surface positions on the main body 102 to the printed circuit 104. In some examples, the printed circuit 104 may include connection wiring, logic components, electrodes, and / or conductive pads for receiving electronic components. In some cases, the electronic components may include mounted rigid-flex circuits.

[0041] Figure 3 shows an exemplary layout of a printed circuit 300 of another WANS device. Referring to Figure 3, the printed circuit 300 includes a front section 302 (similar to the layout of the printed circuit of the front section 202a shown, for example, in Figure 2D), an upper rear section 304a, and a lower rear section 304b. The upper rear section 304a includes an electrode 306a connected to a pairing 306b on the front section 302. The lower rear section 304b includes an electrode 308a connected to a pairing 308b on the front section 302. The front section 302 further includes an electrode 310.

[0042] Referring to Figure 2B, the partial view of the wearable body section 200 in Figure 2A shows the printed circuitry mounted on the front portion 202a and the portion that goes inside the ear 202c. As shown, the electrical wiring is defined from each projection 208a-208m to the electrical contacts (e.g., electrical contacts 226a-n) mounted thereon. Furthermore, the same partial view of the wearable body section 200 is reproduced in Figure 2C, which here includes labels referring to wells 210a-e. As shown, well 210c contains two electrical contacts 228a, 228b mounted therein. Similarly, well 210e has two electrical contacts 228c, 228d mounted therein, and well 210f has two electrical contacts 228e, 228f mounted therein.

[0043] As shown in Figures 2B and 2C, the first electrode pairing 220a, 220b is positioned between the ear canal portion 202c (e.g., placed over the opening 204c in Figure 2A) and the anterior portion 202a. The electrode pad 222b of the second electrode pairing (e.g., between the anterior portion 202a and the posterior portion 202b) is located on the opposite side of the anterior portion electrode 224 (e.g., placed over the opening 204a in Figure 2A). The electrode pairings may be arranged to contact, for example, a drive circuit for delivering therapeutic pulses via the electrodes (e.g., 220a and 224).

[0044] Although shown as a single layer of printed circuitry, in other embodiments, multiple layers can be created, for example, by placing additional flexible material of the mounting body section 200 on top of at least a portion of the first layer of printed circuitry and / or the layer of dielectric material. In further embodiments, the second layer of circuitry may be placed on the corresponding mounting body section 200 (e.g., cover 108 in Figure 1), and the layers of circuitry may be connected when the first body section and the second body section are pressed together.

[0045] Returning to Figure 1, in some implementations, various electronic components 106 are added to the printed circuit board 104. In the first example, the electronic components 106 may include motion sensor components such as one or more accelerometers and / or gyroscopes (e.g., MEMS gyroscopes) to track the wearer's movement and / or orientation. For example, a gyroscope can be used to determine when the wearer is not oriented nearly vertically, such as in the case of a disoriented pilot who may not be aiming along the horizon, so that a stimulus can be applied to treat motion sickness. Similarly, an accelerometer can be used to determine when the pilot's body is being exposed to G-forces that could lead to motion sickness. In other exemplary examples, motion sensors can be used to recognize involuntary movements of the wearer, such as physical tics / tremors, or to track the wearer's activities (e.g., motor routines). In the second example, the electronic component 106 may include one or more commercially available bio-monitoring electrical sensors, vibration sensors, and / or acoustic sensors to recognize the wearer's biosignature (e.g., pulse, heart rate). The biosignature may be used, for example, as feedback to control therapy (e.g., initiation, adjustment, and / or termination). In the third example, the electronic component 106 may include a power source such as a battery. In the fourth example, the electronic component 106 may include an input / output (I / O) device, which in some examples is one or more buttons, one or more switches, one or more pressure touch sensors, one or more light-emitting diodes (LEDs), one or more speakers, one or more microphones, and / or one or more connectors (e.g., cable connectors or multi-pin connectors) for tethering an external device. The external device may be a controller, such as a stimulation generator and / or an external power supply, as an example.

[0046] In some implementations, the electronic component 106 includes one or more integrated circuits (ICs) and / or printed circuit boards (PCBs). In some examples, a boost converter can be added using the PCB to control the impedance at critical locations in the circuit. In another example, the PCB may include a quad flat no-lead (QFN) package for heat dissipation. In yet another example, a Bluetooth IC module or other wireless transceiver can be added to provide wireless communication between the WANS device 100 and a controller and / or separate WANS devices, for example, WANS devices designed as a pair to coordinate therapy delivered to the left and right ears of a wearer.

[0047] In some embodiments, wireless communication enables the WANS to communicate with sensors. In some cases, sensors can provide feedback signals to adjust or control the therapy provided by the WANS. For example, a biosensor that assesses the concentration of cortisol in the skin can provide a signal to determine the user's stress level. In another case, a sensor can be used to assess electromyography (EMG) activity and provide early detection of intent to activate muscles, or a motion sensor can provide information about limb movements. In these two cases, the sensor signals may be used, for example, as triggers for stroke recovery training protocols. In yet another example, a sensor that provides pupillary measurements may be used as a measure of attention, alertness, or arousal (or lack thereof). Such signals may be used as feedback to adjust therapy to maintain a desired level of attention, alertness, and / or arousal. Similarly, in a further example, attention, alertness, and / or arousal may be assessed by an ultrasound sensor that measures cerebral blood flow velocity (CBFV). In such embodiments, CBFV may be used as feedback to adjust therapy.

[0048] In some implementations, robotic pick-and-place manufacturing is used to add at least a portion of the electronic components 106 to the printed circuit 104. The robotic system can align the electronic components 106 with the contact pads printed for each electronic component 106, for example, using a programmed coordinate arrangement based on the print coordinates. In another example, the automated system can use sensors to detect the coordinates of the contact pads printed for adding various electronic components 106.

[0049] In some implementations, at least a portion of the electronic component 106 is soldered in place. For example, specific electronic components 106 can be connected by manual or robotic soldering. In some implementations, at least a portion of the electronic component 106 is attached to the printed circuit board 104 using conductive epoxy. In further implementations, at least a portion of the electronic component 106 is mated in place using pins, snaps, or other mechanical connectors to permanently or removablely secure each electronic component 106 in place on the printed circuit board 104. In some implementations, specific electronic components 106 can be sufficiently fixed to the printed pads of the printed circuit board 104 by heat and / or ultraviolet (UV) curing.

[0050] Referring to Figure 2D, in the initial addition of electronic components to the front section 202a, a pair of electronic components 230a-f are attached to protrusions 208a-k. Furthermore, electronic components 232a and 232b are added to wells 210d and 210e.

[0051] Referring to Figure 2E, in the second addition of electronic components to the front section 202a, a PCB or IC 234, an input control 236 with a push button 238, and an LED 240 are added to the area including wells 210a, 210b, and 210d, electrode 224, electrode pairings 222 and 220b.

[0052] In Figure 2F, an overhead view of the WANS-mounted main unit section 200 shows the completed circuit including the positioning of additional electronic components. As shown, the rear section 202b includes a power element 242 (e.g., a button battery). As shown in Figure 2B, to connect to the power element 242, the inclined projection 244 provides an inclined surface for mounting printed circuit wiring, thereby avoiding mounting at right angles or similarly sharp angles (e.g., greater than 85°, greater than 80°, greater than 75°, etc.) which may be more susceptible to damage or breakage.

[0053] Returning to Figure 1, in some implementations, after completing the circuit deposition 104 and circuit component addition 106 within the body section 102, a cover 108 can be added to enclose the printed circuit 104 and electronic components 106 within the body 102. The cover 108 may be formed as a cap or lid that extends substantially downward along the side of the body section 102, as shown in the figure. In other embodiments, the cover 108 may wrap at least partially around the body section 102, for example, to enhance water resistance and / or retention. The cover 108 may be formed from the same material as the body section 102 or from a different material. For example, the cover 108 may be molded or 3D printed using one or more flexible materials. In some embodiments, the cover 108 is overmolded onto the body section 102. The overmolded cover 108 may be formed using one or more flexible materials that are the same as or different from the material of the body section 102. In some embodiments, the cover 108 may include one or more openings for passing through I / O electrical components, such as one or more buttons, power cord connectors, controller connectors, and / or LEDs. The cover may further include openings that allow skin contact with one or more electrodes. In some embodiments, the cover 108 includes one or more transparent areas to allow visual indicators, such as LEDs, to pass through. Referring to Figure 4, for example, the cover 400 for the body section 200 in Figures 2A–2G includes a connector port 402, an LED port 404, and a button control port 406.

[0054] Returning to Figure 1, in some implementations, the conductive adhesive 110 is added to the back of the main body section 102 of the WANS at the electrode(s)(s)(s) to transfer energy from the electrodes of the WANS device 100 to the wearer's skin. The conductive adhesive 110 may include, for example, a hydrogel and / or another conductive adhesive suitable for skin contact (e.g., a carbon-based adhesive). Depending on the electrode positions, in some embodiments, the conductive adhesive may be placed on the front of the cover 108 and the back of the main body section 102. In some embodiments, the conductive adhesive 110 is a conductive double-sided tape that is manually or robotically placed over the electrode positions on the WANS device 100. In some embodiments, the conductive adhesive 110 is three-dimensionally printed on the section of the WANS device 100. In embodiments using directional conductive epoxy, since the directional conductive epoxy is conductive only in the Z direction when cured under a magnetic field, the epoxy may be provided over a wider surface area (e.g., over multiple electrodes, or otherwise substantially coating the skin contact surface of the WANS device 100).

[0055] Referring to Figure 5, the WANS device 500 includes a front portion 502 including a conductive adhesive region 510 and a rear portion 504 including conductive adhesive regions 506 and 508. The conductive adhesive region 510 of the front portion 502 may correspond, for example, to the electrode 310 of the circuit 300 in Figure 3. Similarly, the conductive adhesive region 506 may correspond to the electrode 306a in Figure 3, and the conductive adhesive region 508 may correspond to the electrode 308a in Figure 3.

[0056] In some implementations, the conductive adhesive area 510 is configured to contact the wearer's skin in the region of the auriculotemporal electrode (ATN) and / or the nerve structure connected to the ATN, thereby allowing the delivery of therapeutic stimuli via the conductive adhesive area 510 to modulate ATN activity. Referring to Figures 8A and 8B, for example, the ATN 802 is shown in relation to the person's ear 800 (Figure 8A), running in front of the ear 800, and skeletal in relation to the external auditory canal 810 (Figure 8B). In exemplary examples, the electrode electrically communicating with the conductive adhesive area 506 (e.g., electrode 308a in Figure 3) may be positioned close to the temporomandibular joint.

[0057] In some embodiments, the conductive adhesive area 506 is in contact with the wearer's skin in a region of nerve structures of the auricular branch (ABVN) of the vagus nerve and / or nerve structures connected to the ABVN, thereby configuring the delivery of therapeutic stimuli via the conductive adhesive area 506 to modulate ABVN activity. For example, as shown in Figures 8A–8D, the ABVN 804 emerges to the surface through the mastoid tubule (MsC) 812 (e.g., Arnold's canal) (Figure 8D), and its association with the ear 800 (Figure 8A), the external auditory canal 810 (Figure 8B), and the area behind the ear (Figure 8C) is illustrated. Referring to Figure 9, the posterior auricular nerve 900 intersects with a branch of the ABVN, providing another target for ABVN stimulation. In exemplary examples, the electrode electrically communicating with the conductive adhesive area 506 (e.g., electrode 306a in Figure 3) may be positioned in close proximity to the MsC.

[0058] In some embodiments, the conductive adhesive region 508 is configured to contact the patient's skin as a return electrode, thereby forming an electrical circuit throughout the tissue using electrodes corresponding to the anterior conductive adhesive region 510 and the posterior conductive adhesive region 506, respectively. While shown as a single return electrode (e.g., region 508) for each positive electrode corresponding to the adhesive regions 510 and 506, in other embodiments, separate return electrodes may be provided for each positive electrode. In further embodiments, three or more return electrode paths may be provided for two positive electrodes. Other combinations are also possible.

[0059] Referring to Figure 2F, a conductive adhesive region is similarly provided, allowing an electrical communication path to be formed from the electrode 220a of the wearable body section 200 to the wearer's skin in the anterior part of the external auditory canal. Referring to Figure 10, the electrode 220a may be positioned to stimulate, for example, the external auditory canal nerve branch 1000 of ATN802.

[0060] Returning to Figure 1, in some implementations, a non-conductive adhesive 112, such as a hydrophilic colloid, is applied to the WANS 100 so as to roughly surround each region of the conductive adhesive 110. For example, as shown in Figure 5, the non-conductive adhesive 112 may be provided in roughly region 512a (e.g., around the conductive adhesive 510) and 512b (e.g., between conductive regions 506 and 508, around region 508, and at least partially around region 506). The non-conductive adhesive 112 may be used, for example, to electrically insulate conductive regions generated by electrical communication between the electrodes and the conductive adhesive 110. In this way, the non-conductive adhesive 112 can be used to avoid short circuits in the WANS device 100. In some examples, the non-conductive adhesive 112 may be placed on the front side of the cover 108 and the back side of the main body section 102 (e.g., by spraying or 3D printing). In some embodiments, the non-conductive adhesive 112 is double-sided tape that is manually or robotically placed on the WANS device 100. In other embodiments, instead of using a non-conductive adhesive, the gripping material and / or pattern is molded and / or three-dimensionally printed onto sections of the WANS device 100. For example, to improve the retention of the WANS device around the wearer's ear, a three-dimensional adhesive microstructure can be provided on the surface of the main body 102 and / or cover 108.

[0061] In some implementations, one or more liners 114 are placed over the bonding area (e.g., conductive adhesive 110 and non-conductive adhesive 112) to maintain the tackiness and cleanliness of the adhesive material before installation. As shown in Figure 5, for example, a front liner 514a is shown to cover the bonding areas 510 and 512a of the front section 502, and a rear liner 514b is shown to cover the bonding areas 506, 508, and 512b of the rear section 504. In other embodiments, a single liner may be provided to cover all bonding areas of the WANS.

[0062] Referring to Figure 13A, another exemplary WANS device 1300 is shown. Similar to the first exemplary WANS device 100 in Figure 1, the WANS device 1300 includes a front section 1302a, a rear section 1302b, and an ear-mount section 1302c. Compared to the internal diagram of the first exemplary WANS device 100 shown in Figure 1, the WANS device 1300 replaces many of the smaller components of the WANS device 100 with the same or similar functions provided by a set of circuit components, such as shown in the flexible body section 1304 of the WANS device 1300. The circuit components may be used, for example, in place of certain printed circuit components of the first exemplary WANS device 100 in Figure 1. Furthermore, certain circuit components may integrate one or more of the electronic components described in relation to the WANS device 100, as described in relation to Figures 2A to 2G. In some examples, circuit components may include flexible circuit printed circuit boards (PCBs), rigid-flex PCBs, and / or rigid-flex PCBs. Certain circuit components may be bent, curved, and / or folded to create a three-dimensional surface area of ​​the PCB, thereby enabling the circuit component to best fit within the three-dimensional structure of the flexible body portion 1302. Different circuit components may have different manufacturing types, for example, based on the type of circuit and / or positioning. For example, components that need to maintain a position (e.g., mechanical buttons or switches, LEDs, etc.) may be formed as less flexible (e.g., rigid-flex) or more rigid circuit components, while components in high-flex areas (e.g., a portion of the WANS device 1300 enclosing the auricle) and / or components that need to bend or fold to fit into an assigned position within the WANS device 1300 may be manufactured as flexible circuit components.

[0063] As shown in the figure, the front portion 1302a of the exemplary WANS device 1300 includes an input circuit component 1306 on which a mechanical control component (e.g., a button switch) 1308 is mounted on top. The flexible body portion 1304 includes a mounting platform 1310 for supporting the input circuit component 1306 with the mechanical control component 1308. In some embodiments, the mounting platform 1310 is formed as part of the flexible body portion 1304. In other embodiments, the mounting platform 1310 is printed or disposed within the flexible body portion 1304. For example, the mounting platform 1310 may be formed of a harder / more rigid material than the flexible body portion 1304 in order to hold the mechanical control component 1310 in position on the surface of the cover of the WANS device 1300 (e.g., the cover 1350 in Figure 13B).

[0064] As shown in the first detail drawing 1500 of the WANS device 1300 in Figure 15A, the input circuit component 1306 is electrically connected to the circuit component 1312 by a three-dimensionally formed flexible circuit bridge 1502. For example, the flexible circuits bridging the components of the WANS device 1300 may include wiring for each signal type carried by a particular device, as well as power wiring to supply power to the entire components of the WANS device 1300. The flexible circuits bridging the components may be connected to other components (such as rigidflex, rigidizeflex, etc.) by pin connections, for example.

[0065] The circuit components 1312 of the front portion 1302a include, in some embodiments, various circuit components (e.g., resistors, capacitors, etc.) to support the function of the WANS device. The circuit components 1312 are electrically connected to the processing circuit components 1314 via the flexible circuit bridge component 1504.

[0066] In some embodiments, the circuit component 1312 is positioned on a rounded (e.g., circular) cavity 1326a, which has one or more flexible protrusions extending from and / or surrounding the cavity 1326a. For example, the cavity 1326a may house and / or be surrounded by a pattern of small pillars, thereby allowing the circuit component 1312 to slide against the flexible protrusions during bending of the WANS device 1300. The flexible protrusions can further generate frictional forces, for example, to maintain the movement of the circuit component 1312 in a limited area. In one example, the friction element may be made at least partially by sandwiching the circuit component 1312 between two sets (e.g., an upper set and a lower set) of small flexible protrusions. In other embodiments, the frictional effect may be generated by the type of material (e.g., sticky, adhesive, etc.) and / or finish (e.g., roughness and / or pattern formation) of the flexible protrusion(s). As shown in Figures 15A and 15B, for example, cavity 1326a is surrounded by pillar 1506. Cavity 1326a and projections are described in more detail below in relation to Figures 14A to 14D.

[0067] The processing circuit component 1314 (e.g., a microcontroller) controls therapeutic nerve stimulation delivered via electrodes in the front portion 1302a, the rear portion 1302b, and the ear-rest portion 1302c, in some implementation configurations. The electrodes may be electrically connected to the processing circuit component 1314 via printed circuit wiring, via extensions from one of the circuit and / or flexible circuit components, and / or via pin connections to electronic components, in some examples.

[0068] As shown in the figure, for example, pin 1340 extends through an extension 1336 of the processing circuit component 1314 to connect at least one first electrode to the processing circuit component 1314. The extension 1336 may be, for example, a flexible circuit extension of the printed circuit board of the processing circuit component 1314. Pin 1340 extends into an opening (e.g., a via) 1338 of the flexible body 1304. In Figure 15A, a first detail drawing 1500 of the WANS device 1300 shows the layout more clearly. For example, electrodes can be made by three-dimensional printing on the back of the flexible body 1304 and then filling the opening 1338 with conductive ink to ensure electrical connection with the processing circuit component 1314. The conductive ink may harden once it is placed as an electrode and filled into a via.

[0069] In another example, an ear-mounted flexible circuit component 1344 (e.g., a flex circuit, rigidflex circuit, rigidizeflex circuit, etc.) is connected to a processing circuit component 1314 to provide power and communication to one or more electrodes located on or electrically communicating with the ear-mounted flexible circuit component 1344.

[0070] In another example, the processing circuit component 1314 may be electrically connected (for example, via printed circuit wiring) to the electrodes of the rear section 1302b. In some embodiments, the processing circuit component 1314 may be indirectly connected to other electrodes via another circuit component, such as the power circuit component 1324 of the rear section 1302b.

[0071] As shown in the figure, the output electronic component 1316 is mounted on top of the processing circuit component 1314. In some examples, the output electronic component 1316 may be a haptic feedback component, a speaker component, and / or a lighting component. The output electronic component 1316 can be controlled, for example, by the processing circuit component 1314 to present the wearer with vibration and / or audible alarms, such as a low battery alarm or a therapy start alarm. In some implementations, the therapeutic device includes one or more haptic feedback actuators between electrode pairs. The haptic feedback actuator(s) can move from a first position to a second position in a repeating pattern, for example, to mask the sensation felt by the stimulation of the electrodes. The haptic feedback actuator(s) may be configured to separate or electrically insulate conductive shunts between electrodes, for example, between portions of conductive gel.

[0072] In some implementations, the processing circuit component 1314 and the lighting circuit component 1318 are arranged adjacent to each other within the rectangular cavity 1346. The cavity allows, for example, the connector of the processing circuit component 1314 to be aligned with the bottom surface of the flexible body 1304, thereby avoiding unnecessary bending of the flexible circuit connector component 1342 or the ear-mounted flexible circuit 1344.

[0073] In some embodiments, the lighting circuit component 1318 provides the user with illumination feedback indicating, for example, that the WANS device 1300 is powered on, has low battery power, and / or is currently active during therapy. In some embodiments, the lighting circuit is supported by one or more protrusions (e.g., pillars or bases), such as pillars 1322, and positions the lighting adjacent to the surface of the WANS device 1300 and / or partially through the cover of the WANS device 1300 (e.g., exposing one or more light-emitting diode (LED) lamps 1320). In some embodiments, LEDs can be used to signal the output intensity of the WANS.

[0074] Referring to Figure 15B, in the second detailed drawing 1510 of the WANS device 1300, the lighting circuit component 1318 is shown on the pillar 1322 (e.g., a base or platform), and the lighting circuit component 1318 is positioned closer to the height of the output component 1316. As shown, the three-dimensional curved branch 1342a of the flexible circuit connector component 1342 connects the processing circuit component 1314 and the lighting component 1318 to the circuit of the rear section 1302b. Returning to Figure 13A, as shown, the flexible circuit connector component 1342 connects to the power circuit component 1324 or the transition circuit component 1332 of the rear section 1302b.

[0075] In some implementations, the power circuit component 1324 manages the power distribution to the circuits and components of the WANS device 1300. As shown in the figure, the power circuit component 1324 is placed on a rounded (e.g., elliptical) cavity (e.g., well, recess) 1326b. In some embodiments, a rounded cavity 1326b smaller than the power circuit component 1324 can provide the power circuit component 1324 with a limited range of motion. The power circuit component 1324 communicates directly electrically with an inductor component 1328 located next to the battery 1330.

[0076] Referring to Figure 15C, a third detail diagram 1520 of the WANS device 1300 shows an inductor component 1328 connected to a power circuit component 1324 by a flexible circuit connector 1534. In particular, the flexible circuit connector 1534 is connected to an inductor circuit component 1536 on which the inductor 1328 is mounted.

[0077] As shown in the figure, the battery 1330 (for example, a coin cell battery) is installed in a rectangular cavity 1522. In some embodiments, the position of the battery 1330 is maintained by an adhesive placed or positioned within the cavity 1522.

[0078] In some implementations, the transition circuit component 1332 (e.g., PCB) is connected using three-dimensional printed wiring to enable electrical communication between the battery 1330, electrodes, and / or circuit components (e.g., components 1306, 1312, 1314, 1318, and 1324). Referring to Figure 15C, for example, printed circuit wiring 1524 electrically connects the transition circuit component 1332 to the battery. The first portion of printed circuit wiring 1524a extends from the transition circuit component 1332 down the inclined projection 1528a, along the underside of the flexible body 1304, down the inclined portion 1526, and into the cavity 1522, where it electrically connects to the battery 1330. A second portion of the printed circuit wiring 1524b exits the cavity via another inclined section (not shown), travels along the underside of the flexible body 1304, ascends the inclined projection 1528b, and reaches the transition circuit component 1332.

[0079] In some mounting configurations, the transition circuit component 1332 is also connected to a rear portion electrode via a via 1530. The printed circuit trace 1532 runs down another inclined projection 1528c from the transition circuit component 1332 and over the via 1530. Similar to the pin 1340 shown in detail in Figure 15A, electrodes can be printed on the outer surface of the flexible body 1304 and the via 1530 can be filled with conductive material to form an electrical connection between the transition circuit component 1332 and the electrode.

[0080] Flexible circuit bridge components 1538 and 1540 connect the transition circuit component 1332 to the power circuit component 1324 and the capacitor circuit component 1334, respectively. The capacitor circuit component 1334 may be provided to support the power circuit component 1324.

[0081] Referring to Figure 14A, the first detailed cross-sectional view 1400 shows a circuit component 1312 suspended above the cavity 1326a by a ring of pillar component 1506. Furthermore, an upper pillar component 1402 extends downward and connects with the circuit component 1312. The upper pillar component 1402 may be formed on or incorporated into, for example, the cover 1350 of the WANS device 1300. As shown, the upper pillar component 1402 surrounds the upper cavity 1404 within the cover 1350. When assembling the flexible body 1304 with the cover 1350, the combination of the lower cavity 1326a and the upper cavity 1404 provides a peripheral cavity region that can limit the movement of the circuit component 1312. The pillar rings of the flexible body 1304 and cover 1350 can also be seen in the perspective view of the WANS device 1300 in Figure 13B.

[0082] The upper pillar component 1402 and / or the lower pillar component 1506 are, in some embodiments, deformable and flexible so as to be able to respond to both lateral and compressive forces caused by the bending of the WANS device 1300. For example, referring to the second detailed cross-sectional view 1410 in Figure 14B, when the WANS device 1300 bends within the area of ​​circuit component 1312, certain pillars can bend at a certain angle (best seen, for example, the upper pillar 1402d and the lower pillar 1506b). Furthermore, certain pillars 1402 and / or 1506 can be compressed to adjust to the forces applied by the bending of the WANS device 1300.

[0083] In some implementations, forces applied to the WANS device 1300, including bending forces, compressive forces, and / or gravity, cause the circuit component 1312 to shift back and forth (for example, between the input circuit component 1306 and the processing circuit component 1314). Referring to Figures 14C and 14D, comparative cross-sectional views 1430 and 1440 of the WANS device 1300 illustrate an exemplary range of lateral motion of the electronic component 1312.

[0084] As described in relation to electronic component 1312, the designs shown in Figures 14A to 14D may generally be extended to other layouts of one or more compressible / deformable / flexible upper elements and corresponding one or more compressible / deformable / flexible lower elements, the lower elements providing a cavity for the component along with some range of movement of the component due to stress applied to the WANS device 1300. The movable holding mechanism provided by sandwiching the component between the upper flexible element(s) and lower flexible element(s) can prevent, for example, damage to the connection and / or damage to the appearance of the component itself during use of the WANS device 1300.

[0085] In embodiments other than those shown in Figures 14A to 14D, pillars and / or cavities of different shapes and sizes may be used, such as a pillar positioned beneath the power circuit component 1324 within the elliptical cavity 1326b in Figure 13A. In further embodiments, cavities may not be provided. For example, two raised regions may instead provide a "nesting" in which components may be placed.

[0086] Although the pillars are shown as rectangular blocks, in other implementations they may be formed as circular, hexagonal, or other shapes. Furthermore, in some implementations the pillars may be tapered (e.g., rounded cones, or truncated cones or pyramids).

[0087] In some implementations, instead of pillars, areas of flexible material can be cut or notched to provide mobility. For example, a raised ring formed in a donut shape can be cut and slit to allow bending and / or curvature. In other implementations, a matching pair of three-dimensional flexible donut-shaped areas (e.g., body portion 1304 and cover 1350) may be provided to allow deformation during or while bending and some sliding operation.

[0088] Figures 7A and 7B show flowcharts of an exemplary method 700 for manufacturing a WANS device, such as device 100 in Figure 1, device 500 in Figure 5, and / or device 1300 in Figure 13B.

[0089] In some implementations, Method 700 begins by creating a three-dimensional (3D) circuit layout designed to incorporate electronic circuit components within the volume of the WANS device while conveniently positioning I / O components for user-friendliness. In some embodiments, a rigid or rigid-flex PCB containing multiple electronic components is treated as a single electronic component and incorporated into the WANS 3D circuit layout itself. Furthermore, in some embodiments, a flexible circuit connector with electrical wiring connections for transferring signals from one circuit component to another may be treated as an electronic component. The 3D circuit layout may be designed, for example, using a computer-aided design software package.

[0090] In some implementations, a flexible body portion of the WANS device is manufactured including protrusions and / or wells to support a three-dimensional circuit layout (704). The flexible body portion may be manufactured, for example, as described in relation to body portion 102 in Figure 1. The protrusions and / or wells may be manufactured, for example, in the same manner as described in relation to protrusion 208 and / or well 210 in Figure 2A. The flexible body portion may be manufactured to have one or more openings for therapeutic electrode communication and / or access to I / O circuit elements. The openings may be, for example, similar to opening 204 in Figure 2A. In some embodiments, one or more openings are formed in the flexible body portion after manufacturing. In some examples, one or more openings can be punched out or laser-cut from a molded part or a printed part.

[0091] In some implementations, conductive wiring, therapeutic electrodes, and / or other printed circuits are mounted on the flexible body portion (706). The printed circuits may be mounted as described, for example, in relation to printed circuit 104 in Figure 1, the printed circuit shown in Figure 2B, and / or printed circuit 300 in Figure 3. The printed circuits may include one or more therapeutic electrodes, such as electrodes 220a and 224 in Figure 2B, electrode 222a in Figure 2F, and / or electrodes 306a, 308a, and 310 in Figure 3. The printed circuits may include one or more landing pads and / or connecting components (e.g., electrical contacts 226a-n in Figure 2B) for adding one or more electronic components, such as electronic component 106 in Figure 1, to the 3D circuit.

[0092] In some implementations, if optional connecting components and / or landing pads are provided (708), at least one of one or more electronic components is added to the printed circuit at the location of the landing pad and / or connecting component (710). Adding electronic components may include soldering, inserting, and / or gluing each component. Certain components may be added to the printed circuit automatically, while others may be added to the printed circuit manually. Electronic components may be added as described, for example, in relation to electronic component 106 in Figure 1.

[0093] In some implementations, any remaining electronic components are added to the 3D circuit layout (712). For example, circuit components and flexible circuit connectors may be added to the 3D circuit layout of the WANS device 1300 in Figure 13A.

[0094] In some implementations, a dielectric layer is added on top of the printed circuit and / or electronic components (714). In some examples, the dielectric layer may be printed, 3D printed, and / or sprayed onto the printed circuit and / or electronic components. The dielectric layer can protect the printed circuit and / or electronic components from short circuits, crosstalk, and / or signal delays, for example. The dielectric layer can also provide thermal conductivity to prevent overheating of the circuit components.

[0095] In some implementations where the three-dimensional circuit layout includes two or more layers (716), one or more of operations 706 to 714 can be repeated. For example, an added dielectric layer (714) can be used to separate multiple layers of conductive wiring, allowing them to intersect each other across different layers. As shown in Figures 2D and 2E, for example, electronic components may be added to one or more layers on top of the printed circuit. In another example, after placing a particular electronic component, additional wiring can be added, such as wiring 1524 and 1532 connecting to a transition component 1332 as shown in Figure 15C, to link a particular component and / or connect a particular component to other features of the printed circuit (e.g., electrodes, landing pads, etc.). After placing wiring 1524 and 1532, for example, a battery 1330 can be added to the 3D circuit layout of the WANS device 1300 in Figure 13A (710).

[0096] In some implementations, if the 3D circuit layout includes an outer layer on the outer surface of the flexible body portion (718), conductive wiring, one or more therapeutic electrodes, and / or other printed circuits are placed on the outer surface of the flexible body portion (720). For example, electrodes may be formed and vias 1338 and 1530 filled, as described in relation to Figures 13A and 15C.

[0097] In some implementations, a cover is positioned on the flexible body portion to enclose printed circuits and electronic components (722). The cover may be formed from the same or similar material as the flexible body portion. In some examples, the cover may be molded, overmolded, and / or three-dimensional printed. In some embodiments, the cover includes one or more features, such as one or more seals and / or drainage channels, to provide a water-resistant or waterproof seal with the flexible body portion. The cover may be designed similarly to, for example, cover 108 in Figure 1.

[0098] In some embodiments, the cover includes one or more openings, such as openings 404 and 406 in the cover 400 of Figure 4. Positioning the cover may involve aligning the opening(s) of the cover with one or more features of printed circuits and / or electronic components. Referring to Figure 6, a diagram of a fully assembled transparent WANS device 600 is shown to illustrate the internal positioning of various components and circuits shown in Figures 2A to 2E. As illustrated, the button 238 and LED 240 are exposed by openings in the cover (e.g., the cover 400 in Figure 4). In other embodiments, the material of the cover is thinned in certain areas so that the LED 240 or more LEDs are visible through the remaining thickness of the cover material when light is shone on them, for example, without actual openings, thus keeping the inside of the WANS sealed.

[0099] Referring to Figure 7B, in some implementations, conductive adhesive is added to the location of one or more therapeutic electrodes (724). Furthermore, as described in relation to Figures 3 and 5, the electrodes may include return electrodes. The conductive adhesive may be added, for example, in one or more of the methods described with respect to the conductive adhesive 110 in Figure 1. In certain embodiments, although shown in relation to the flexible portion, conductive adhesive may be added to the location of one or more electrodes aligned with the cover of the WANS device.

[0100] In some implementations, the non-conductive adhesive is added to substantially surround the location of one or more conductive adhesive regions (726). The non-conductive adhesive may be added, for example, in one or more of the methods described in relation to the non-conductive adhesive 112 in Figure 1. The non-conductive adhesive may partially or completely surround the conductive adhesive, as described and illustrated in relation to Figure 5. In certain embodiments, although shown in relation to the flexible portion, the non-conductive adhesive may be added to the cover of the WANS device at locations around one or more conductive adhesive regions added.

[0101] In some implementations, the adhesive areas of the WANS device (e.g., conductive and / or non-conductive) are covered with one or more protective liners (728). The liners can maintain the adhesive quality and cleanliness of the adhesive areas of the device until the device is fitted. The liners may be provided, for example, in relation to liner 114 in Figure 1 and / or liners 514a, 514b in Figure 5. In another example, as shown in Figure 6, a front liner 602a, a rear liner 602b, and a liner 602c for the part that goes inside the ear are provided to cover the adhesive area.

[0102] In exemplary cases, therapeutic devices such as device 100 in Figure 1 or device 1300 in Figure 13 may be mounted as follows: In mounting configurations having a protective liner on the skin adhesive and / or on the electrodes, remove the protective liner before use. Place the auricle component around the patient's auricle and press the patient's skin so that the exposed skin adhesive and adhesive / hydrogel (or other conductive adhesive) adhere to the skin. Next, position the auricle component in the ear so that at least a portion of the auricle component is positioned outside the external auditory canal within the external auditory canal and / or engages with the concha.

[0103] For example, electrodes can be made larger or combined so that multiple electrodes, such as contact pads 804a, 804b, and 804c, are combined to form one large contact. In some embodiments, the therapeutic device includes a set of electrodes configured to be virtually grouped together to form one or more effective electrodes. For example, a first group of electrodes may correspond to electrode 804a, a second group of electrodes may correspond to electrode 804b, and a third group of electrodes may correspond to electrode 804c. Grouping smaller electrodes provides the ability to have multiple electrodes, each having a current source that is independently controlled, enabling current steering, thereby providing better spatial resolution and targeting capabilities. The electrodes may be virtually grouped by a processing circuit.

[0104] Although Method 700 is described in relation to a specific set of operations, in other embodiments, more or fewer operations may be included in Method 700. For example, in other embodiments, a second flexible body portion may be manufactured that is designed to mate with a first flexible body portion to complete the connection of a shared circuit between the flexible body portions, rather than positioning the cover (722). In certain embodiments, one or more operations may be performed in different orders or in parallel. For example, conductive adhesives and non-conductive adhesives may be added in different orders and / or simultaneously (724, 726).

[0105] The WANS device 100 in Figure 1, the WANS device 500 in Figure 5, and the WANS device 1300 in Figure 13A are described as devices worn on one ear of a patient, but other forms of the WANS device can be constructed using the general operational flow of Method 700, for example, devices worn on both ears of a patient, or devices having a flexible body portion and a three-dimensional circuit for delivering therapy to other parts of the wearer's face and / or neck, such as a band designed to contact the wearer's temples and / or jawline. In the exemplary example including two auricle units, the WANS device includes identical or similar elements for the flexible body portion of each ear, but may be printed in a similar manner (e.g., substantially mirror-image). In addition to this example, the two flexible body portions may be connected by a band or cord. The band or cord may be molded and / or printed in a manner similar to that described with respect to the flexible body portion (704). The flexible body portions may be connected by, for example, an elastic “telephone cord” coil band, a flat elastic band, a flat semi-rigid band, or other physical connection connecting two flexible body portions. Rather than creating a continuous device having two auricle units and connectors (e.g., bands, cables, cords, etc.), in some embodiments two separate auricle units can each be mounted to a shared connector or plugged in. For example, each auricle unit can be pivotably or rotatably mounted to the connector (e.g., using a ball joint, a rotary hinge, etc.) to make contact with the ear and assist in adjusting the auricle unit. The three-dimensional circuit layout may be designed to include a master flexible body portion including a controller configured to deliver coordinated therapy between the two ear portions (702). In another example, the WANS device may include two separate ear-mounted devices formed as described in connection with method 700, at least one of the ear-mounted devices including a control circuit, and each ear-mounted device including a wireless communication circuit for coordinating the delivery of therapeutic pulses.

[0106] Referring to Figure 11, the exemplary WANS device 1100 includes two auricle units 1102a, 1102b connected by a band 1116 configured to be worn around the back of the wearer's head (e.g., in contact with the back of the head). Similar to the WANS device 100 described in relation to Figures 2A to 2E, each auricle unit 1102 of the WANS device 1100 includes an anterior portion 1104, a posterior portion 1106, and an ear rest portion 1108. As shown, the left auricle unit 1102a includes a control button 1110 and an indicator light 1112. The skin-facing surfaces of the anterior portions 1104a, 1104b, the posterior portions 1106a, 1106b, and the ear rest portions 1108a, 1108b are protected by liners 1114a to f.

[0107] In some implementations, the control housing 1118 is positioned on the band 1116. In some embodiments, the control housing 1118 includes a control circuit for delivering therapeutic pulses via the electrodes of the auricle units 1102a and 1102b. In some embodiments, the control housing 1118 includes a wireless communication unit for receiving control commands from a separate device. For example, the pulse generator component of the control housing 1118 may be controlled by commands delivered via wireless communication. The control housing 1118 may further include a power circuit, such as a battery unit for supplying power to the auricle units 1102a and 1102b.

[0108] Referring to Figure 12, a block diagram 1200 of exemplary components of a pulse generator 1250 communicating with exemplary components of an auricle component 1260 is shown. In some embodiments, the multi-channel pulse generator circuit 1250 has a microcontroller or microprocessor 1210, which has at least one core. For example, if there are multiple microcontrollers or multiple cores, one can control the wireless communication 1220, and the other core(s) can be dedicated to controlling the therapy. In some implementations, a low-power programmable logic circuit (e.g., a field-programmable gate array (FPGA) or programmable logic device (PLD)) 1212 is also provided. For example, the microcontroller 1210 may be configured to switch to a low-power mode as often as possible while the programmable logic circuit 1212 controls the therapy delivery.

[0109] In some embodiments, inverter circuits 1245a~n are used to generate two-phase / bipolar pulses. In some embodiments, one inverter circuit 1245a~n is used for each channel 1270a~n, and in other embodiments, a single inverter circuit 1245 is used for multiple channels 1270a~n. Each channel 1245a~n can target, for example, a different anatomical region (e.g., tissue region) 1248a~n. By using high voltage compliance (e.g., >50V, >70V in other embodiments, >90V in yet another embodiment), one or more high-voltage inverters 1240a~n can be provided for each inverter circuit 1245a~n, thereby ensuring that there is a sufficient margin at potential to generate the current required by the intensity control 1242a~n of each inverter circuit 1245a~n. For added safety, in some embodiments, overcurrent detection circuits 1244a~n are provided for each inverter circuit 1245a~n. In some embodiments, impedance measurement circuits 1246a-n are provided for each inverter circuit 1245a-n. The impedance measurement circuits 1246a-n can support tracking impedance over time to identify, for example, failures in adequate therapy delivery. In some examples, therapy delivery may be impaired if the electrodes are not in contact with or are not in good contact with the target tissue 1248a-n, if the cable or connector of the multi-channel pulse generator 1250 is disconnected from one of the auricle components 1260, or if the electrodes are degraded or defective. Monitoring impedance over time provides the additional benefit of being able to track the condition of the contact electrodes, allowing the controller to warn the user when the contact electrodes are nearing the end of their lifespan or are no longer usable. The FPGA 1212 can control the inverter circuits 1245a-n and receive feedback from the inverter control components 1238a-n.

[0110] In some implementations, a battery 1232 is used to power the pulse generator 1250. The battery 1232 can, for example, power components of the pulse generator 1250 and / or auricle components(s) 1260 via one or more low-voltage converters 1234. Furthermore, the pulse generator 1250 may include a high-voltage converter 1236 coupled to one or more high-voltage inverters 1240a-1240n to deliver electrical stimulation therapy via one or more channels 1245a-n.

[0111] In some embodiments, an isolated port 1218, such as a Universal Serial Bus (USB), is used to charge the battery 1232 (e.g., via a battery charging circuit 1230) and to communicate with the microcontroller(s) 1210 (e.g., via a communication port 1216). Communication may be in both ways, allowing for the uploading of instructions or entire new code to the microcontroller(s) 1210 and the downloading of information stored in memory 1222. In some embodiments, memory 1222 or additional memory can be added to the circuit as an external component (e.g., via wireless or wired communication with a pulse generator 1250). For example, the memory can be connected to the pulse generator 1250 using the isolated port 1218 (e.g., USB). In other embodiments, at least a portion of memory 1222 may be located inside the microcontroller(s) 1210. In some embodiments, the FPGA 1212 may also have internal memory.

[0112] In some embodiments, an external trigger circuit 1224 is included to allow stimulation to be started and / or stopped via an external signal. In some embodiments, the external trigger signal can pass through an isolation port 1218, and in yet other embodiments, the trigger signal can be passed using a modified USB configuration (i.e., not using a standard USB pin configuration). Using a modified USB configuration means that a custom USB cable is used, thereby ensuring that an off-the-shelf USB cable cannot be used to inadvertently provide external triggering. In further embodiments, the external trigger signal may be transmitted wirelessly from a separate source (e.g., by Bluetooth).

[0113] In some embodiments, a hardware user interface is provided for interacting with the multichannel pulse generator 1250 via a user interface circuit 1226. For example, the user interface circuit 1226 may include tactile (e.g., piezoelectric) devices such as buttons, LEDs, and buzzers, and / or displays, or any combination thereof. In some embodiments, the user interface circuit 1226 includes signal processing components for interpreting user interface commands delivered via an external device (e.g., via wireless communication 1220). In some embodiments, the external device may be a smartphone app, a tablet computer, or a medical monitoring device (e.g., in a hospital setting).

[0114] In some embodiments, an external master clock 1228 is used to drive the microcontroller 1210 and / or FPGA 1212. In other embodiments, the component clock(s) can be internal, integrated, or co-packaged with the microcontroller(s) 1210 and / or FPGA 1212. In some embodiments, one or more oscillators, including optionally adjustable oscillators 1214, are used to set pulse parameters such as frequency and / or pulse width.

[0115] In some embodiments, the auricle component 1260 is fabricated from a thin flexible PCB or printed electronics so that it is lightweight and can be easily bent to accommodate different anatomical structures. In some embodiments, the auricle component 1260 has two or more channels. The auricle component 1260 or each of its channels may include peak suppression circuits 1247a-n and electrodes 1265a-n for contact with the skin at the location of target tissue 1248a-n. In some embodiments, the auricle component 1260 includes a unique chip identifier or unique ID chip 1249. The unique ID chip can be used to track usage and prevent other unauthorized circuits from being connected to the multichannel pulse generator 1250. At least one auricle component 1260 is connected to the multichannel pulse generator 1250.

[0116] In exemplary embodiments, the system utilizes feedback to monitor and / or modify the therapy. Feedback may be obtained from one or more sensors capable of monitoring one or more symptoms being treated by the therapy. For example, if one or more symptoms are reduced or resolved, the therapeutic output may be reduced or discontinued accordingly. Conversely, if one or more symptoms are increased or added, the therapeutic output may be activated or modulated accordingly (increase, dilate, etc.). In some embodiments, sensors may monitor one or more of the following: skin electrical activity (e.g., sweating), motor activity (e.g., tremor, physiological movement), glucose levels, nerve activity (e.g., via EEG), muscle activity (e.g., via EMG), and / or cardiopulmonary activity (e.g., EKG, heart rate, blood pressure (systolic, diastolic, and / or mean)). Imaging techniques such as MRI and fMRI can be used to modulate the therapy in a given user's clinical setting. In other embodiments, for example, a mobile phone and / or smart glasses can be used to image pupillary changes (e.g., pupillary dilation) to provide feedback for therapy modification. In some implementations, one or more sensors are integrated into the earpiece and / or conchae. In some implementations, one or more sensors are integrated into the pulse generator. For example, periodic monitoring may be achieved by triggering the wearer to touch one or more electrodes on the system (e.g., electrodes integrated into the surface of the pulse generator) or otherwise interact with the pulse generator (e.g., holding a pulse generator that extends away from the body and using a motion detector within the pulse generator to monitor tremors). In further implementations, one or more sensor outputs may be obtained from an external device such as a fitness computer, smartwatch, or wearable health monitor.

[0117] The monitoring used may be partially based on the therapeutic environment. For example, EEG monitoring is easier in a hospital setting, but heart rate monitoring can be achieved by sensors such as pulse meters built into earpieces, or by other sensors built into low-cost health monitoring devices such as fitness monitoring devices or smartwatches.

[0118] In exemplary embodiments, feedback related to skin electrical activity can be used to monitor and detect the rate or timing of symptoms and / or therapeutic outcomes. In one example, skin electrical activity may be sensed by electrodes on a therapeutic earpiece device. In another example, skin electrical activity may be detected by electrodes on another part of the body and transmitted to the system. In some embodiments, skin electrical electrodes may be such that they detect a specific substance in the skin (e.g., cortisol) via electrochemical means.

[0119] In some implementations, the system may further include one or more motion detectors, such as accelerometers or gyroscopes, which can be used to collect information and adjust the therapy. In one example, one or more motion detectors are configured to detect tremors and / or physiological movements. In one embodiment, the tremors and / or physiological movements may indicate an underlying disease and / or treatment of the underlying disease. In one example, the tremors and / or physiological movements may indicate symptoms associated with substance withdrawal. In one embodiment, feedback from glucose monitoring can be used to adjust the therapy.

[0120] In further implementations, EKG can be used to assess heart rate and heart rate variability, determine autonomic nervous system activity in the overall and / or relative activity of the sympathetic and parasympathetic branches of the autonomic nervous system, and adjust therapy accordingly. Autonomic nervous system activity can manifest symptoms associated with substance withdrawal. In one embodiment, a therapeutic device can be used to provide therapy for treating cardiac diseases such as atrial fibrillation and heart failure. In one example, therapy can be provided for the regulation of the autonomic nervous system. In some implementations, a therapeutic device can be used to provide therapy that balances the ratios between any combination of the autonomic nervous system, parasympathetic nervous system, and sympathetic nervous system.

[0121] In one embodiment, the system can monitor impedance measurements that enable closed-loop nerve stimulation. In one example, monitoring feedback can be used to alert the patient / caregiver if the therapy is not delivered properly and if the therapeutic device is removed.

[0122] While specific embodiments have been described, these embodiments are presented merely as examples and are not intended to limit the scope of this disclosure. In fact, the novel methods, apparatuses, and systems described herein can be embodied in a variety of other forms. Furthermore, various omissions, substitutions, and modifications in the forms of the methods, apparatuses, and systems described herein can be made without departing from the spirit of this disclosure. The appended claims and their equivalents are intended to encompass forms or modifications that fall within the scope and spirit of this disclosure.

Claims

1. A wearable auricular stimulator, A first flexible body portion adapted to be fitted at least partially around the wearer's auricle, The outer surface that faces the skin, The first flexible body portion comprises the inner side opposite to the outer side facing the skin, and having at least one projection for supporting a three-dimensional circuit layout, wherein the at least one projection projects away from the outer side facing the skin, The three-dimensional circuit on the inside of the first flexible body portion, A plurality of conductive wires are configured such that at least a portion of them is placed on the first flexible body portion so that they stretch and / or bend as the first flexible body portion moves, The three-dimensional circuit comprises a plurality of electrodes configured to deliver electrical stimulation therapy to the wearer via the outer surface of the first flexible body portion facing the skin, A plurality of electronic components coupled to the three-dimensional circuit, Multiple electronic components are electrically coupled to one or more corresponding wirings among the multiple conductive wirings and / or one or more corresponding electrodes among the multiple electrodes of the three-dimensional circuit. The plurality of electronic components comprises two or more elements of different types selected from the group of element types consisting of lighting elements, processing circuit elements, physical control elements, communication elements, memory elements, and combinations thereof. Each electronic component of one or more of the aforementioned electronic components is positioned above or above each of the at least one of the aforementioned protrusions, A wearable auricular stimulator comprising: a second flexible body portion that fits with the first flexible body portion and is configured to substantially enclose the three-dimensional circuit and the plurality of electronic components.

2. One or more of the aforementioned plurality of electronic components are incorporated into at least one circuit component. The wearable auricular stimulator according to claim 1, wherein coupling one or more electronic components to the three-dimensional circuit includes attaching at least one circuit component to the inside of the first flexible body portion.

3. The wearable auricular stimulator according to claim 2, wherein the at least one circuit component comprises one or more flex circuits, one or more rigid flex circuits, and / or one or more rigid flex circuits.

4. The wearable auricular stimulator according to claim 2 or 3, wherein the at least one circuit component comprises one or more three-dimensionally formed circuit components having one or more bent or curved portions.

5. The at least one projection includes at least one pair of flexible projections, and each pair of flexible projections at least partially supports one or more of the third electronic components among the plurality of electronic components. Each set of flexible protrusions provides the respective electronic component with a limited range of motion relative to the first flexible body portion. The wearable auricular stimulator according to claim 4, wherein each set of flexible protrusions is configured to apply a frictional force to the movement of each of the electronic components.

6. The wearable auricular stimulator according to claim 5, wherein the first set of flexible protrusions among the at least one set of flexible protrusions comprises a plurality of flexible pillars.

7. The wearable auricular stimulator according to claim 6, wherein the second set of flexible protrusions among the at least one set of flexible protrusions comprises a second set of flexible pillars arranged opposite to the set of flexible pillars.

8. The inside of the first flexible body portion is provided with at least one well, The wearable auricular stimulator according to any one of claims 1 to 7, wherein each of the second one or more electronic components among the plurality of electronic components is arranged on one or more wells of the at least one well.

9. The wearable auricular stimulator according to any one of claims 1 to 8, wherein the first flexible body portion has one or more openings passing through the first flexible body portion so as to be positioned in close proximity to the auricle and to electrically communicate with the wearer's skin, and at least one surface of each electrode of at least a portion of the plurality of electrodes is exposed.

10. The wearable auricular stimulator according to any one of claims 1 to 9, wherein at least one of the first flexible body portion or the second flexible body portion has one or more openings, and at least one of the plurality of electronic components is accessible through each of the one or more openings while the first flexible body portion and the second flexible body portion are fitted together.

11. The wearable auricular stimulator according to claim 10, wherein the at least one electronic component comprises a control button or a control switch.

12. The wearable auricular stimulator according to any one of claims 1 to 11, wherein the first flexible main body portion is molded as a continuous molded piece of a single material.

13. The first flexible body portion is A first section configured to be aligned substantially in front of the auricle, A wearable auricular stimulator according to any one of claims 1 to 12, comprising: a second section configured to contact and substantially align with the rear of the auricle.

14. The wearable auricular stimulator according to claim 13, wherein the plurality of conductive wirings of the three-dimensional circuit comprises a first plurality of conductive wirings that electrically connect a portion of the plurality of electronic components arranged in the second section to a portion of the three-dimensional circuit arranged in the first section.

15. The wearable auricular stimulator according to claim 14, wherein the first plurality of conductive wirings of the three-dimensional circuit electrically connect a portion of the plurality of electrodes arranged in the second section to at least one of the therapeutic stimulation sources of the plurality of electronic components arranged in the first section or the return electrodes of the plurality of electrodes arranged in the first section.

16. The wearable auricular stimulator according to claim 14 or 15, further comprising a third section configured to maintain the first flexible body portion in at least one of the concha or ear canal of the auricle.

17. The wearable auricular stimulator according to claim 16, wherein at least one electrode among the plurality of electrodes is arranged in the third section.

18. A wearable auricular stimulator according to any one of claims 13 to 17, wherein a first electrode among the plurality of electrodes configured to be positioned on, over, or adjacent to a branch of the auricular-temporal nerve (ATN) is positioned in the first section of the first flexible body portion.

19. The wearable auricular stimulator according to claim 18, wherein the branch of the ATN is the external auditory canal nerve.

20. A wearable auricular stimulator according to any one of claims 13 to 19, wherein the first electrode among the plurality of electrodes is configured to be positioned on, along with, or in close proximity to the auricular branch (ABVN) of the vagus nerve near the point in which the ABVN faces the mastoid canal (MsC), and is positioned in the second section of the first flexible body portion.

21. A wearable auricular stimulator, A first flexible body portion adapted to be fitted at least partially around the wearer's auricle, The outer surface that faces the skin, The first flexible body portion comprises an inner side opposite to the outer side facing the skin, which has at least one projection for supporting a three-dimensional circuit layout, wherein the at least one projection projects away from the outer side facing the skin. The three-dimensional circuit on the inside of the first flexible body portion, A plurality of conductive wires, at least partially placed on the first flexible body portion, wherein at least a portion of the plurality of conductive wires is configured to stretch and / or bend as the first flexible body portion moves, The three-dimensional circuit comprises a plurality of electrodes configured to deliver electrical stimulation therapy to the wearer via the outer surface of the first flexible body portion facing the skin, A plurality of electronic components coupled to the three-dimensional circuit, Each of the plurality of electronic components is electrically coupled to one or more corresponding wirings among the plurality of conductive wirings and / or one or more corresponding electrodes among the plurality of electrodes of the three-dimensional circuit. The plurality of electronic components comprises two or more elements of different types selected from the group of element types consisting of lighting elements, processing circuit elements, physical control elements, communication elements, memory elements, and combinations thereof. Each electronic component of one or more of the aforementioned electronic components is positioned above or above each of the at least one of the aforementioned protrusions, A wearable auricular stimulator comprising: a second flexible body portion that fits with the first flexible body portion and is configured to substantially enclose the three-dimensional circuit and the plurality of electronic components.

22. One or more of the aforementioned plurality of electronic components are incorporated into at least one circuit component. The wearable auricular stimulator according to claim 21, wherein coupling one or more electronic components to the three-dimensional circuit includes attaching at least one circuit component to the inside of the first flexible body portion.

23. The wearable auricular stimulator according to claim 22, wherein the at least one circuit component comprises one or more flex circuits and / or one or more rigid flex circuits and / or one or more rigid flex circuits.

24. The wearable auricular stimulator according to claim 22 or 23, wherein the at least one circuit component comprises one or more three-dimensionally formed circuit components having one or more bent or curved portions.

25. The at least one projection includes at least one pair of flexible projections, and each pair of flexible projections at least partially supports one or more of the third electronic components among the plurality of electronic components. Each set of flexible protrusions provides the respective electronic component with a limited range of motion relative to the first flexible body portion. Each set of flexible protrusions is configured to apply a frictional force to the movement of each of the electronic components. The wearable auricular stimulator according to claim 24.

26. The wearable auricular stimulator according to claim 25, wherein the first set of flexible protrusions among the at least one set of flexible protrusions comprises a first plurality of flexible pillars.

27. The wearable auricular stimulator according to claim 26, wherein the second flexible body portion comprises a second plurality of flexible pillars arranged opposite to the first plurality of flexible pillars.

28. The inside of the first flexible body portion is provided with at least one well, Each of the third one or more electronic components among the plurality of electronic components is placed on one or more wells of the at least one well. A wearable auricular stimulator according to any one of claims 21 to 27.

29. The wearable auricular stimulator according to any one of claims 21 to 28, wherein the first flexible body portion has one or more openings passing through the first flexible body portion so as to be positioned in close proximity to the auricle and to electrically communicate with the wearer's skin, and at least one surface of each electrode of at least a portion of the plurality of electrodes is exposed.

30. The wearable auricular stimulator according to any one of claims 21 to 29, wherein at least one of the first flexible body portion or the second flexible body portion has one or more openings, and at least one of the plurality of electronic components is accessible through each of the one or more openings while the first flexible body portion and the second flexible body portion are fitted together, and the at least one electronic component comprises a control button or a control switch.

31. The wearable auricular stimulator according to any one of claims 21 to 30, wherein the first flexible main body portion is molded as a continuous molded piece of a single material.

32. The first flexible body portion is A first section configured to be aligned substantially in front of the auricle, A wearable auricular stimulator according to any one of claims 21 to 31, comprising: a second section configured to contact and substantially align with the rear of the auricle.

33. The wearable auricular stimulator according to claim 32, wherein the plurality of conductive wirings of the three-dimensional circuit comprises a first plurality of conductive wirings that electrically connect a portion of the plurality of electronic components arranged in the second section to a portion of the three-dimensional circuit arranged in the first section.

34. The wearable auricular stimulator according to claim 33, wherein the first plurality of conductive wirings of the three-dimensional circuit electrically connect a portion of the plurality of electrodes arranged in the second section to at least one of the therapeutic stimulation sources of the plurality of electronic components arranged in the first section or the return electrodes of the plurality of electrodes arranged in the first section.

35. The wearable auricular stimulator according to claim 33 or 34, further comprising a third section configured to be maintained in at least one of the concha or ear canal of the auricle, wherein at least one of the plurality of electrodes is positioned in the third section.

36. A wearable auricular stimulator formed by a process including the following, namely: Manufacturing a first flexible body portion configured to at least partially enclose the auricle of one ear such that the wearable auricular stimulator is substantially supported by the wearer's ear and has an outer side facing the skin and an inner side opposite to the outer side facing the skin, wherein the first flexible body portion comprises at least one of i) one or more projections formed on the inner side and projecting from the outer side facing the skin, or ii) one or more wells formed on the inner side. The first circuit of the three-dimensional circuit layout is placed on the inside of the first flexible body portion, wherein the first circuit is A plurality of first conductive wires are placed along the base surface of the inner surface, i) along each of the projections of at least a portion of the one or more projections, and / or ii) within each of the wells of at least a portion of the one or more wells, a second plurality of conductive wirings extending from the base surface, Multiple electrodes, a) one or more conductive landing pads, or b) one or more conductive connecting components, comprising at least one of these, for mounting, a) at each of the one or more landing pads, or b) at at least one of the one or more connecting components, one or more electronic components of the three-dimensional circuit layout are coupled to the first circuit, A wearable auricular stimulator formed by a process that includes enclosing the three-dimensional circuit layout within the wearable auricular stimulator by covering the first flexible body portion with a second flexible body portion.

37. At least one of the one or more electronic components mentioned above is incorporated into at least one circuit component. The wearable auricular stimulator according to claim 36, wherein coupling one or more electronic components to the first circuit includes attaching at least one circuit component to the first flexible body portion.

38. The wearable auricular stimulator according to claim 36 or 37, wherein the process further comprises adding a conductive adhesive to at least one outer surface of the first flexible body portion or the second flexible body portion at the locations of one or more therapeutic electrodes among the plurality of electrodes.

39. The wearable auricular stimulator according to any one of claims 36 to 38, wherein manufacturing the first flexible body portion includes manufacturing one or more openings in the first flexible body portion, and each of the one or more openings is positioned at the location of each of the electrodes of the plurality of electrodes.

40. The wearable auricular stimulator according to any one of claims 36 to 39, wherein manufacturing the first flexible body portion includes adding a conductive adhesive to at least one of the one or more wells for bonding the first electronic component of the one or more electronic components to the first flexible body portion.

41. The wearable auricular stimulator according to any one of claims 36 to 40, wherein the process further comprises adding a dielectric layer on top of the three-dimensional circuit layout.

42. The wearable auricular stimulator according to any one of claims 36 to 41, wherein covering the first flexible body portion includes aligning the opening of the second flexible body portion with a portion of the electronic components of the first flexible body portion.

43. The wearable auricular stimulator according to any one of claims 36 to 42, wherein manufacturing the first flexible body portion includes mold molding the first flexible body portion from a flexible material comprising one or more of rubber, plastic, or silicone.

44. A wearable auricular stimulator according to any one of claims 36 to 43, wherein covering the first flexible body portion includes overmolding the second flexible body portion onto the first flexible body portion.

45. The wearable auricular stimulator according to any one of claims 36 to 44, wherein covering the first flexible body portion seals the second flexible body portion to the first flexible body portion so that the wearable auricular stimulator is waterproof or water-resistant.

46. The wearable auricular stimulator according to any one of claims 36 to 45, wherein the second flexible body portion is manufactured from the same material as the first flexible body portion.

47. The wearable auricular stimulator according to any one of claims 36 to 46, wherein manufacturing the first flexible body portion comprises forming a set of regions having a material thinner than the thickness of the rest of the first flexible body portion, and each region of the set of regions is configured to receive each of the electrodes of the plurality of electrodes.

48. A wearable auricular stimulator formed by a process including the following, namely: Manufacturing a first flexible body portion configured to wrap at least partially around the wearer's ear such that the wearable auricular stimulator is substantially supported by the wearer's ear and has an outer side facing the skin and an inner side opposite to the outer side facing the skin, wherein the first flexible body portion comprises at least one of i) one or more projections formed on the inner side and projecting from the outer side facing the skin, or ii) one or more wells formed on the inner side. The first circuit of the three-dimensional circuit layout is applied to the inside of the first flexible body portion, wherein the first circuit is Multiple flexible conductive wirings, A portion of the plurality of flexible conductive wirings includes a plurality of flexible conductive wirings that extend i) on each of the protrusions of at least a portion of the one or more protrusions, and / or ii) within each of the wells of at least a portion of the one or more wells, Multiple electrodes, Applicable to: a) one or more conductive landing pads, or b) one or more conductive connecting components, at least one of these, a) at each of the one or more landing pads, or b) at at least one of the one or more connecting components, one or more electronic components of the three-dimensional circuit layout are coupled to the first circuit, A wearable auricular stimulator formed by a process that includes enclosing the three-dimensional circuit layout within the wearable auricular stimulator by covering the first flexible body portion with a second flexible body portion.

49. The wearable auricular stimulator according to claim 48, wherein the one or more electronic components include one or more of the following: an illumination element, a processing circuit element, a physical control element, a communication element, or a memory element.

50. At least one of the one or more electronic components mentioned above is incorporated into at least one circuit component. The wearable auricular stimulator according to claim 48 or 49, wherein coupling one or more electronic components to the first circuit includes attaching at least one circuit component to the first flexible body portion.

51. The wearable auricular stimulator according to claim 50, wherein the at least one circuit component comprises one or more flex circuits, one or more rigid flex circuits, and / or one or more rigid flex circuits.

52. The wearable auricular stimulator according to claim 50, wherein the at least one circuit component comprises one or more three-dimensionally formed circuit components including one or more bent or curved portions.

53. The wearable auricular stimulator according to any one of claims 48 to 52, wherein the process further comprises adding a conductive adhesive to at least one outer surface of the first flexible body portion or the second flexible body portion at the location of one or more of the electrodes.

54. The wearable auricular stimulator according to any one of claims 48 to 53, wherein manufacturing the first flexible body portion includes manufacturing one or more openings in the first flexible body portion, and each opening of at least a portion of the one or more openings is positioned at the location of each electrode of the plurality of electrodes.

55. The wearable auricular stimulator according to any one of claims 48 to 54, wherein manufacturing the first flexible body portion includes manufacturing one or more openings in the first flexible body portion, and each opening of at least a portion of the one or more openings is positioned at the location of a control element of the one or more electronic components.

56. The wearable auricular stimulator according to any one of claims 48 to 55, wherein manufacturing the first flexible body portion includes adding a conductive adhesive to at least one of the one or more wells for bonding the first electronic component of the one or more electronic components to the first flexible body portion.

57. The wearable auricular stimulator according to any one of claims 48 to 56, wherein the process further comprises adding a dielectric layer on top of the three-dimensional circuit layout.

58. The wearable auricular stimulator according to any one of claims 48 to 57, wherein covering the first flexible body portion includes aligning the opening of the second flexible body portion with a portion of the electronic components of the first flexible body portion.

59. The wearable auricular stimulator according to any one of claims 48 to 58, wherein manufacturing the first flexible body portion includes mold molding the first flexible body portion from a flexible material comprising one or more of rubber, plastic, or silicone.

60. A wearable auricular stimulator according to any one of claims 48 to 59, wherein covering the first flexible body portion includes overmolding the second flexible body portion onto the first flexible body portion.

61. The wearable auricular stimulator according to any one of claims 48 to 60, wherein covering the first flexible body portion seals the second flexible body portion to the first flexible body portion so that the wearable auricular stimulator is waterproof or water-resistant.

62. The wearable auricular stimulator according to any one of claims 48 to 61, wherein the second flexible body portion is manufactured from the same material as the first flexible body portion.

63. The wearable auricular stimulator according to any one of claims 48 to 62, wherein manufacturing the first flexible body portion comprises forming a set of regions having a material thinner than the thickness of the rest of the first flexible body portion, and each region of the set of regions is configured to receive each of the electrodes of the plurality of electrodes.

64. The wearable auricular stimulator according to any one of claims 48 to 63, wherein the first flexible body portion includes a flexible connector portion that connects the auricle mounting section of the first flexible body portion to an ear-rest mounting section configured to be maintained in contact with at least one of the concha or ear canal of the ear, and the ear-rest mounting section includes at least one electrode from the plurality of electrodes.

65. The wearable auricular stimulator according to any one of claims 48 to 64, wherein the method comprises manufacturing one or more openings and / or one or more regions having a material thinner than the thickness of the rest of the second flexible body portion.

66. The wearable auricular stimulator according to claim 65, wherein each opening and / or each region of at least a portion of the one or more openings is positioned at the location of each electrode of the plurality of electrodes.

67. The wearable auricular stimulator according to claim 65 or 66, wherein each opening and / or each region of at least a portion of the one or more openings is positioned at the location of a control element of the one or more electronic components.

68. A system for treating one or more nerve disorders using a wearable auricular stimulator, The aforementioned wearable auricular stimulator is, A flexible body adapted to be fitted at least partially around the wearer's auricle, The external part that contacts the wearer's skin to position it, The flexible body comprises an interior for supporting a three-dimensional circuit layout, The aforementioned three-dimensional circuit layout, A plurality of wires placed on the internal surface of the flexible body, A plurality of electrodes configured to deliver electrical stimulation therapy to the wearer via the skin-facing side of the flexible body, A first electrode among the plurality of electrodes configured to be positioned on, over, or adjacent to a branch of the auricular-temporal nerve (ATN), A three-dimensional circuit layout comprising a plurality of electrodes, each comprising: a second electrode among the plurality of electrodes configured to be positioned on, over, or in close proximity to the auricular branch (ABVN) of the vagus nerve; One or more electronic components electrically coupled to a portion of the plurality of electrodes and / or the plurality of wirings, each comprising one or more electronic components having a processing circuit element for delivering at least one electrical stimulation therapy via the plurality of electrodes, A controller configured to instruct the processing circuit elements of one or more electronic components to deliver the at least one electrical stimulation therapy for treating one or more nerve disorders via the plurality of electrodes, wherein the at least one electrical stimulation therapy is Stimulating the ATN via the first electrode, A controller comprising stimulating the ABVN via the second electrode, A system wherein the flexible body of the wearable auricle stimulator comprises a plurality of openings and / or a plurality of thin-walled regions of the material of the flexible body, enabling electrical communication between each electrode of the plurality of electrodes and the wearer's skin adjacent to the auricle.

69. The interior of the flexible body is provided with at least one projection, Each electronic component of at least one of the aforementioned one or more electronic components is positioned on or above one or more of the aforementioned at least one protrusions. The system according to claim 68.

70. The system according to claim 68 or 69, wherein the one or more neurological disorders include one or more of stress, anxiety, migraine, cluster headache, depression, post-traumatic stress disorder (PTSD), attention deficit / hyperactivity disorder (ADHD), attention deficit disorder (ADD), phobia, or addictive behavior.

71. The system according to any one of claims 68 to 70, wherein the wearable auricular stimulator comprises the controller.

72. The system according to any one of claims 68 to 71, wherein the processing circuit element comprises the controller.

73. A system for inducing neuronal plasticity or nerve plasticity in order to induce cognitive improvement and / or alleviate cognitive decline in a wearer using a wearable auricular stimulation device, The aforementioned wearable auricular stimulator is, A flexible body adapted to be fitted at least partially around the auricle of the wearer, The external part that contacts the wearer's skin to position it, The flexible body comprises an interior for supporting a three-dimensional circuit layout, The aforementioned three-dimensional circuit layout, A plurality of wires placed on the internal surface of the flexible body, A plurality of electrodes configured to deliver electrical stimulation therapy to the wearer via the skin-facing side of the flexible body, A first electrode among the plurality of electrodes configured to be positioned on, over, or adjacent to a branch of the auricular-temporal nerve (ATN), A three-dimensional circuit layout comprising a plurality of electrodes, including a second electrode among the plurality of electrodes configured to be positioned on, over, or in close proximity to the auricular branch (ABVN) of the vagus nerve, One or more electronic components electrically coupled to a portion of the plurality of electrodes and / or the plurality of wirings, each comprising a processing circuit element for delivering at least one electrical stimulation therapy via the plurality of electrodes, A controller configured to instruct the processing circuit elements of one or more electronic components to deliver the at least one electrical stimulation therapy to induce neuronal plasticity or nerve plasticity in the wearer via the plurality of electrodes, wherein the at least one electrical stimulation therapy is Stimulating the ATN via the first electrode, A controller comprising stimulating the ABVN via the second electrode, A system wherein the flexible body of the wearable auricle stimulator comprises a plurality of openings and / or a plurality of thin-walled regions of the material of the flexible body for enabling electrical communication between each electrode of the plurality of electrodes and the wearer's skin adjacent to the auricle.

74. The interior of the flexible body is provided with at least one projection, Each electronic component of at least one of the aforementioned one or more electronic components is positioned on or above one or more of the aforementioned at least one protrusions. The system according to claim 73.

75. The system according to claim 73 or 74, wherein inducing neuronal plasticity or neural plasticity in the wearer includes one or more of the following: improved learning, accelerated recovery from stroke, improved memory, or increased vigilance.

76. The system according to claim 75, wherein improving memory includes alleviating and / or slowing the progression of symptoms of dementia and / or Alzheimer's disease.

77. The system according to any one of claims 73 to 76, wherein the wearable auricular stimulator comprises the controller.

78. The system according to any one of claims 73 to 77, wherein the processing circuit element comprises the controller.

79. A system for reducing the wearer's pain using a wearable auricular stimulator, The aforementioned wearable auricular stimulator is, A flexible body adapted to be fitted at least partially around the wearer's auricle, The external part that contacts the wearer's skin to position it, The flexible body comprises an interior for supporting a three-dimensional circuit layout, The aforementioned three-dimensional circuit layout, A plurality of wires placed on the internal surface of the flexible body, A plurality of electrodes configured to deliver electrical stimulation therapy to the wearer via the skin-facing side of the flexible body, A first electrode among the plurality of electrodes configured to be positioned on, over, or adjacent to a branch of the auricular-temporal nerve (ATN), A three-dimensional circuit layout comprising a plurality of electrodes, including a second electrode among the plurality of electrodes configured to be positioned on, over, or in close proximity to the auricular branch (ABVN) of the vagus nerve, One or more electronic components electrically coupled to a portion of the plurality of electrodes and / or the plurality of wirings, the one or more electronic components comprising a processing circuit element for delivering at least one electrical stimulation therapy via the plurality of electrodes, A controller configured to instruct the processing circuit elements of one or more electronic components to deliver the at least one electrical stimulation therapy to alleviate the wearer's pain via the plurality of electrodes, wherein the at least one electrical stimulation therapy is Stimulating the ATN via the first electrode, A controller comprising stimulating the ABVN via the second electrode, A system wherein the flexible body of the wearable auricle stimulator comprises a plurality of openings and / or a plurality of thin-walled regions of the material of the flexible body for enabling electrical communication between each electrode of the plurality of electrodes and the wearer's skin adjacent to the auricle.

80. The interior of the flexible body is provided with at least one projection, Each electronic component of at least one of the aforementioned one or more electronic components is positioned on or above one or more of the aforementioned at least one protrusions. The system according to claim 79.

81. The system according to claim 79 or 80, wherein the at least one electrical stimulation treatment is configured to treat one or more of the following: substance withdrawal symptoms, migraines, cluster headaches, acute pain, chronic pain, menstrual cramps, or temporomandibular joint disorders (TMD).

82. The system according to any one of claims 79 to 81, wherein the wearable auricular stimulator comprises the controller.

83. The system according to any one of claims 79 to 82, wherein the processing circuit element comprises the controller.

84. A system for increasing the coagulation rate and / or reducing bleeding in a wearer using a wearable auricular stimulator, The aforementioned wearable auricular stimulator is, A flexible body adapted to be fitted at least partially around the wearer's auricle, The external part that contacts the wearer's skin to position it, The flexible body comprises an interior for supporting a three-dimensional circuit layout, The aforementioned three-dimensional circuit layout, A plurality of wires placed on the internal surface of the flexible body, A plurality of electrodes configured to deliver electrical stimulation therapy to the wearer via the skin-facing side of the flexible body, A first electrode among the plurality of electrodes configured to be positioned on, over, or adjacent to a branch of the auricular-temporal nerve (ATN), A three-dimensional circuit layout comprising a plurality of electrodes, including a second electrode among the plurality of electrodes configured to be positioned on, or in close proximity to, the auricular branch (ABVN) of the vagus nerve, One or more electronic components electrically coupled to a portion of the plurality of electrodes and / or the plurality of wirings, the one or more electronic components comprising a processing circuit element for delivering at least one electrical stimulation therapy via the plurality of electrodes, A controller configured to instruct the processing circuit elements of one or more electronic components to deliver, via the plurality of electrodes, the at least one electrical stimulation therapy to increase the wearer's coagulation rate and / or reduce bleeding, wherein the at least one electrical stimulation therapy is Stimulating the ATN via the first electrode, A controller comprising stimulating the ABVN via the second electrode, A system wherein the flexible body of the wearable auricle stimulator comprises a plurality of openings and / or a plurality of thin-walled regions of the material of the flexible body for enabling electrical communication between each electrode of the plurality of electrodes and the wearer's skin adjacent to the auricle.

85. The interior of the flexible body is provided with at least one projection, Each electronic component of at least one of the aforementioned one or more electronic components is positioned on or above one or more of the aforementioned at least one protrusions. The system according to claim 84.

86. The system according to claim 84 or 85, wherein the at least one electrical stimulation treatment is configured to improve coagulation ability and / or reduce bleeding ability prior to bleeding of the wearer.

87. The system according to claim 86, wherein the at least one electrical stimulation therapy is configured to be delivered to the wearer before surgical treatment.

88. The system according to any one of claims 84 to 87, wherein the at least one electrical stimulation therapy is configured to be delivered to a wearer having a coagulation disorder.

89. The system according to claim 88, wherein the coagulation disorder is one of hemophilia, hemophilia A, hemophilia B, hemophilia C, von Willebrand disease (VWD), factor I deficiency, factor II deficiency, factor V deficiency, factor VII deficiency, factor X deficiency, factor XII deficiency, or factor XIII deficiency.

90. The system according to any one of claims 84 to 89, wherein the at least one electrical stimulation treatment is configured to treat menorrhagia and / or severe menstrual bleeding.

91. The system according to any one of claims 84 to 90, wherein the at least one electrical stimulation treatment is configured to treat internal bleeding.

92. The system according to any one of claims 84 to 91, wherein the wearable auricular stimulator comprises the controller.

93. The system according to any one of claims 84 to 92, wherein the processing circuit element comprises the controller.

94. A system for increasing the coagulation rate and / or reducing bleeding in a wearer using a wearable auricular stimulator, The aforementioned wearable auricular stimulator is, A flexible body adapted to be fitted at least partially around the wearer's auricle, The external part that contacts the wearer's skin to position it, The flexible body comprises an interior for supporting a three-dimensional circuit layout, The aforementioned three-dimensional circuit layout, A plurality of electrodes configured to deliver electrical stimulation therapy to the wearer via the skin-facing side of the flexible body, A first electrode among the plurality of electrodes configured to be positioned on, over, or adjacent to the branch of the auricular-temporal nerve (ATN), and / or A three-dimensional circuit layout comprising the plurality of electrodes, the plurality of electrodes comprising a second electrode among the plurality of electrodes configured to be positioned on, on, or in close proximity to, the auricular branch (ABVN) of the vagus nerve, One or more electronic components, each of which is electrically coupled to i) a portion of the plurality of electrodes and / or ii) one or more flexible conductive wirings among a plurality of flexible conductive wirings placed on the internal surface of the flexible body, and which comprises one or more electronic components, each comprising a processing circuit element for delivering at least one electrical stimulation therapy via the plurality of electrodes, A controller configured to instruct the processing circuit elements of one or more electronic components to deliver the at least one electrical stimulation therapy to increase the wearer's coagulation rate and / or reduce bleeding via the plurality of electrodes, wherein the at least one electrical stimulation therapy is Stimulating the ATN through the first electrode, and / or A controller comprising stimulating the ABVN via the second electrode, A system wherein the flexible body of the wearable auricular stimulator comprises a plurality of openings and / or a plurality of thin-walled regions of the material of the flexible body to enable electrical communication between each electrode of the plurality of electrodes and the wearer's skin.

95. The interior of the flexible body is provided with at least one projection, Each electronic component of at least one of the aforementioned one or more electronic components is positioned on or above one or more of the aforementioned at least one protrusions. The system according to claim 94.

96. The system according to claim 94 or 95, wherein the at least one electrical stimulation treatment is configured to improve coagulation ability and / or reduce bleeding ability prior to bleeding of the wearer.

97. The system according to claim 96, wherein the at least one electrical stimulation therapy is configured to be delivered to the wearer before surgical treatment.

98. The system according to any one of claims 94 to 97, wherein the at least one electrical stimulation therapy is configured to be delivered to a wearer having a coagulation disorder.

99. The system according to claim 98, wherein the coagulation disorder is one of hemophilia, hemophilia A, hemophilia B, hemophilia C, von Willebrand disease (VWD), factor I deficiency, factor II deficiency, factor V deficiency, factor VII deficiency, factor X deficiency, factor XII deficiency, or factor XIII deficiency.

100. The system according to any one of claims 94 to 99, wherein the at least one electrical stimulation treatment is configured to treat menorrhagia and / or severe menstrual bleeding.

101. The system according to any one of claims 94 to 100, wherein the at least one electrical stimulation treatment is configured to treat internal bleeding.

102. The system according to any one of claims 94 to 101, wherein the wearable auricular stimulator comprises the controller.

103. The system according to any one of claims 94 to 102, wherein the processing circuit element comprises the controller.

104. The system according to any one of claims 94 to 103, wherein the one or more electronic components further comprises one or more of the following: an illumination element, a physical control element, a communication element, or a memory element.

105. The system according to any one of claims 94 to 104, wherein the interior of the flexible body comprises one or more wells formed on the interior side, and a portion of the plurality of flexible conductive wirings extends into each well of at least a portion of the one or more wells.

106. At least one of the one or more electronic components is incorporated into at least one circuit component. The system according to any one of claims 94 to 105, wherein electrically coupling the at least one electronic component with i) a portion of the plurality of electrodes and / or ii) a portion of the plurality of flexible conductive wirings includes attaching the at least one circuit component to the first flexible body portion.

107. The system according to claim 106, wherein the at least one circuit component comprises one or more flex circuits, one or more rigid flex circuits, and / or one or more rigid flex circuits.

108. The system according to claim 106, wherein the at least one circuit component comprises one or more three-dimensionally formed circuit components having one or more bent or curved portions.

109. The flexible body comprises a first section configured to be aligned substantially in front of the auricle, A second section configured to contact and substantially align with the rear of the auricle, The system according to any one of claims 94 to 108.

110. The aforementioned flexible body is An auricle attachment portion that is at least partially attached around the auricle of the wearer, An ear rest mounting portion configured to be in contact with and maintained on at least one of the concha or ear canal of the ear, The system includes a flexible connector that connects the auricle attachment portion to the ear rest attachment portion, The system according to any one of claims 94 to 109, wherein the ear-rest attachment portion comprises at least one electrode from the plurality of electrodes.

111. The system according to any one of claims 94 to 110, wherein the flexible body of the wearable auricular stimulator comprises at least one opening and / or at least one thin-walled material region of the flexible body for allowing the wearer to operate the control elements of one or more electronic components.

112. The aforementioned flexible body, The first flexible body portion, The outer side facing the skin is configured to come into contact with the skin around the auricle of the wearer, A first flexible body portion comprising an inner side opposite to the outer side facing the skin, The system according to any one of claims 94 to 111, comprising: a second flexible body portion that fits with the first flexible body portion and is configured to substantially enclose the three-dimensional circuit and the plurality of electronic components; and a second flexible body portion.

113. The system according to claim 112, wherein the second flexible body portion comprises one or more openings and / or one or more thin-walled regions of the material of the second flexible body portion to enable electrical communication between each electrode of one or more of the plurality of electrodes and the wearer's skin.

114. A system for reducing inflammation in the wearer using a wearable auricular stimulator, The aforementioned wearable auricular stimulator is, A flexible body adapted to be fitted at least partially around the wearer's auricle, The external part that contacts the wearer's skin to position it, The flexible body comprises an interior for supporting a three-dimensional circuit layout, The aforementioned three-dimensional circuit layout, A plurality of wires placed on the internal surface of the flexible body, A plurality of electrodes configured to deliver electrical stimulation therapy to the wearer via the skin-facing side of the flexible body, A first electrode among the plurality of electrodes configured to be positioned on, over, or adjacent to a branch of the auricular-temporal nerve (ATN), A three-dimensional circuit layout comprising a plurality of electrodes, the plurality of electrodes comprising: a second electrode among the plurality of electrodes configured to be positioned on, on, or in close proximity to, the auricular branch (ABVN) of the vagus nerve; One or more electronic components electrically coupled to a portion of the plurality of electrodes and / or the plurality of wirings, each comprising one or more electronic components having a processing circuit element for delivering at least one electrical stimulation therapy via the plurality of electrodes, A controller configured to instruct the processing circuit elements of one or more electronic components to deliver the at least one electrical stimulation therapy to reduce inflammation in the wearer via the plurality of electrodes, wherein the at least one electrical stimulation therapy is Stimulating the ATN via the first electrode, A controller comprising stimulating the ABVN via the second electrode, A system wherein the flexible body of the wearable auricle stimulator comprises a plurality of openings and / or a plurality of thin-walled regions of the material of the flexible body for enabling electrical communication between each electrode of the plurality of electrodes and the wearer's skin adjacent to the auricle.

115. The interior of the flexible body is provided with at least one projection, Each electronic component of at least one of the aforementioned one or more electronic components is positioned on or above one or more of the aforementioned at least one protrusions. The system according to claim 114.

116. The system according to claim 114 or 115, wherein the at least one electrical stimulation therapy is configured to treat a lung infection.

117. The system according to claim 116, wherein the lung infection is COVID-19 or long COVID.

118. The system according to any one of claims 114 to 117, wherein the at least one stimulating treatment is configured to treat sepsis and / or pancreatitis.

119. The system according to any one of claims 114 to 118, wherein the wearable auricular stimulator comprises the controller.

120. The system according to any one of claims 114 to 119, wherein the processing circuit element comprises the controller.

121. A wearable auricular stimulator formed by a process including the following, namely: Manufacturing a first flexible body portion configured to wrap at least partially around the wearer's ear such that the wearable auricular stimulator is substantially supported by the wearer's ear and has an outer side facing the skin and an inner side opposite to the outer side facing the skin, wherein the first flexible body portion comprises at least one of i) one or more projections formed on the inner side and projecting from the outer side facing the skin, or ii) one or more wells formed on the inner side. The first circuit of the three-dimensional circuit layout is applied to the inside of the first flexible body portion, wherein the first circuit is Multiple flexible conductive wirings, A portion of the plurality of flexible conductive wirings includes a plurality of flexible conductive wirings that extend i) on each of the protrusions of at least a portion of the one or more protrusions, and / or ii) within each of the wells of at least a portion of the one or more wells, Multiple electrodes, a) one or more conductive landing pads, or b) one or more conductive connecting components, to be applied, a) connecting one or more electronic components of the three-dimensional circuit layout to the first circuit at the location of one or more landing pads, or b) at the location of at least one of the one or more connecting components, A wearable auricular stimulator formed by a process that includes enclosing the three-dimensional circuit layout within the wearable auricular stimulator by covering the first flexible body portion with a second flexible body portion.

122. The wearable auricular stimulator according to claim 121, wherein the one or more electronic components comprise one or more of the following: an illumination element, a processing circuit element, a physical control element, a communication element, or a memory element.

123. At least one of the one or more electronic components mentioned above is incorporated into at least one circuit component. The wearable auricular stimulator according to claim 121 or 122, wherein coupling the one or more electronic components to the first circuit includes attaching the at least one circuit component to the first flexible body portion.

124. The wearable auricular stimulator according to claim 123, wherein the at least one circuit component comprises one or more flex circuits, one or more rigid flex circuits, and / or one or more rigid flex circuits.

125. The wearable auricular stimulator according to claim 123 or 124, wherein the at least one circuit component comprises one or more three-dimensionally formed circuit components having one or more bent or curved portions.

126. The wearable auricular stimulator according to any one of claims 121 to 125, wherein the process further comprises adding a conductive adhesive to at least one outer surface of the first flexible body portion or the second flexible body portion at the location of one or more of the electrodes of the plurality of electrodes.

127. The wearable auricular stimulator according to any one of claims 121 to 126, wherein manufacturing the first flexible body portion comprises manufacturing one or more openings in the first flexible body portion, and each opening of at least a portion of the one or more openings is positioned at the location of each electrode of the plurality of electrodes.

128. The wearable auricular stimulator according to any one of claims 121 to 127, wherein manufacturing the first flexible body portion includes manufacturing one or more openings in the first flexible body portion, and each opening of at least a portion of the one or more openings is positioned at the location of a control element of the one or more electronic components.

129. The wearable auricular stimulator according to any one of claims 121 to 128, wherein manufacturing the first flexible body portion includes adding a conductive adhesive to at least one of the one or more wells for bonding the first electronic component of the one or more electronic components to the first flexible body portion.

130. The wearable auricular stimulator according to any one of claims 121 to 129, wherein the process further comprises adding a dielectric layer on the three-dimensional circuit layout.

131. The wearable auricular stimulator according to any one of claims 121 to 130, wherein covering the first flexible body portion includes aligning the opening of the second flexible body portion with a portion of the electronic components of the first flexible body portion.

132. The wearable auricular stimulator according to any one of claims 121 to 131, wherein the manufacturing of the first flexible body portion includes molding the first flexible body portion from a flexible material comprising one or more of rubber, plastic, or silicone.

133. A wearable auricular stimulator according to any one of claims 121 to 132, wherein covering the first flexible body portion includes overmolding the second flexible body portion onto the first flexible body portion.

134. The wearable auricular stimulator according to any one of claims 121 to 133, wherein covering the first flexible body portion seals the second flexible body portion to the first flexible body portion so that the wearable auricular stimulator is waterproof or water-resistant.

135. The wearable auricular stimulator according to any one of claims 121 to 134, wherein the second flexible body portion is manufactured from the same material as the first flexible body portion.

136. The wearable auricular stimulator according to claim 135, wherein manufacturing the first flexible body portion comprises forming a set of regions having a material thinner than the thickness of the rest of the first flexible body portion, and each region of the set of regions is configured to receive each of the electrodes of the plurality of electrodes.

137. The wearable auricular stimulator according to any one of claims 121 to 136, wherein the first flexible body portion includes a flexible connector portion that connects the auricle mounting section of the first flexible body portion to an ear-rest mounting section configured to be maintained in contact with at least one of the concha or ear canal of the ear, and the ear-rest mounting section includes at least one electrode from the plurality of electrodes.

138. The wearable auricular stimulator according to any one of claims 121 to 137, wherein the method comprises manufacturing one or more openings and / or one or more regions having a material thinner than the thickness of the rest of the second flexible body portion.

139. The wearable auricular stimulator according to claim 138, wherein each opening and / or each region of at least a portion of the one or more openings is positioned at the respective electrode locations of the plurality of electrodes.

140. The wearable auricular stimulator according to claim 138 or 139, wherein each opening and / or each region of at least a portion of the one or more openings is positioned at the location of a control element of the one or more electronic components.

Images