Wearable ear nerve stimulator and method of use

Abstract

In an illustrative embodiment, a wearable ear stimulator includes a flexible body adapted to be worn at least partially around an auricle of a wearer, the flexible body including an outer portion for positioning in contact with a wearer's skin, and an inner portion for supporting a three-dimensional (3D) circuitry layout, the 3D circuitry layout includes a trace deposited on a surface of the interior of the flexible body, an electrode for delivering electrical stimulation therapy to the wearer via a skin-facing side of the flexible body, and an electronic component in electrical connection with the electrode and the trace, the electronic assembly includes processing circuitry elements for delivering electrical stimulation therapy via the electrodes.

Description

[0001] Cross-references to related applications

[0002] This application is a continuation-into-priority of U.S. Patent Application Serial No. 18 / 675,492, entitled “Wearable Auricular Neurostimulator and Methods of Use,” filed May 28, 2024, which is a continuation-into-priority of U.S. Patent Application Serial No. 18 / 209,852, entitled “Wearable Auricular Neurostimulator and Methods of Use,” filed June 14, 2023. Background Technology

[0003] Non-invasiveness, ease of use, and / or application of medical therapies are the goals of novel non-pharmacological treatments. A prime example of these treatments is wearable medical devices. While the primary goals of medical devices are safety and effectiveness, the goals of any wearable device are comfort, ease of use, and aesthetics. These two sets of goals are often difficult to reconcile.

[0004] Devices for stimulating neural structures on and around a patient's ear are designed to provide stimulation with or without puncturing the dermis on or around the ear. For example, non-puncture electrodes can be held abrasively and / or adhesively against the skin on and around the patient's ear to target various neural structures. Compared to systems that rely on dermal puncture electrodes, non-puncture electrodes can have a significantly larger surface area, allowing for the stimulation of multiple nerve endings with a single electrode during therapy. Multiple nerve endings can be located directly below and / or beneath and adjacent to the skin where the non-puncture electrode is positioned. 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 apply and remove the device as desired / needled (e.g., for sleep, showering, etc.). Furthermore, targeting multiple nerve endings is advantageous because stimulating multiple branches of a nerve elicits a stronger response than stimulating a single branch, as is the case when using needle-tip electrodes such as needle electrodes. 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 U.S. Patent No. 11,623,088 entitled “Device and Method for the Treatment of Substance Use Disorders”, each of which is incorporated herein by reference in its entirety.

[0005] Transdermal stimulation of these neural regions can achieve a variety of beneficial treatments. In some instances, these include treating acute or chronic pain, inflammation, and cognitive difficulties. For example, the nucleus tractus solitarius (NTS) receives afferent connections from many areas, including the trigeminal-cervical complex (TCC), the cervical vagus nerve, and the auricular branch of the vagus nerve (ABVN). The TCC is a region in the cervical spine and brainstem, where trigeminal nerve and occipital lobe fiber synapses, including the auriculotemporal nerve (ATN), lesser occipital nerve, and greater auricular nerve, are located. The TCC projects to multiple areas in the brainstem, including, but not limited to, the greater raphe nucleus (NRM) and other parts of the raphe nuclei (referred to herein as raphe nuclei (RN)), locus coeruleus (LC), periaqueductal gray (PAG), basal ganglia (NBM), nucleus fuzzus (NA), ventral tegmental area (VTA), nucleus accumbens (NAc), NTS, and parabrachial nucleus (PbN). Among other things, the NTS projects to higher centers such as the RN (e.g., NRM), LC, and PAG, as well as the hypothalamus, including to the arcuate nucleus (ARC), which receives most of the non-hypothalamic afferent signals from the NTS. Furthermore, there are numerous interconnections between different brainstem nuclei (e.g., PAG, LC, RN, NRM, NBM, PbN, PPN, NA, VTA, NAc); for example, the LC, PAG, and RN (e.g., NRM) project to the NA, and the PPN projects to the VTA. The VTA then projects to the prefrontal cortex, interconnecting with the hypothalamus and hippocampus. The VTA also projects directly to the hippocampus. The hippocampus then projects to the NAc and interconnects with the hypothalamus.

[0006] There are descending indirect connections to the heart, lungs, intestines, and spleen. Indirect connections include connections at least once at another synapse before reaching the target. This means that modulating the activity of these neural circuits can affect the corresponding organs. For example, heart rate can be modulated (e.g., heart rate can be decreased and heart rate variability can be increased); oxygen uptake in the lungs can be increased by increasing bronchial tissue compliance, and thus the availability of oxygen transport can be increased, thereby increasing the likelihood of more oxygen being absorbed into the bloodstream; descending pathways originating from the dorsal motor nucleus of the vagus nerve (DMV) can enhance intestinal motility; since DMV activity is regulated by NTS activity, intestinal motility can be affected by modulating NTS activity; and modulating spleen activity via descending NTS pathways can reduce circulating pro-inflammatory cytokines. 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. In addition, regulating spleen activity can enhance platelet function, thereby achieving faster and more effective clotting; this can also occur even in cases of coagulation factor deficiency (e.g., hemophilia A, B and C, deficiencies of factors I, II, V, VII, X, XII, XIII) and / or the presence of other coagulation defects (e.g., von Willebrand disease, VWD).

[0007] Heart rate variability (HRV) reflects the state of the autonomic nervous system (ANS). Sympathetic branches of the ANS, which are more active under stress, tend to increase heart rate (HR) and decrease HRV; conversely, parasympathetic branches of the ANS tend to decrease HR and increase HRV. While lower HRV is associated with morbidity and mortality in several conditions, higher HRV is associated with health status; therefore, HRV has been used as a health biomarker. For an example of treating stress, see U.S. Patent Application Publication No. 2023 / 0149703, entitled “Devices and Methods for Treating Stress and Improving Alertness Using Electrical Stimulation,” which is incorporated herein by reference in its entirety.

[0008] Among other things, there are at least three distinct opioid receptors: Mu (µ), Delta (δ), and Kappa (κ), which modulate pain and directly and indirectly produce important neuromodulators such as dopamine (DA), norepinephrine (NE), serotonin (5-HT), and acetylcholine (Ach). The body produces endogenous agonist peptides targeting each of these three opioid receptors. These peptides are called endorphins, which bind primarily to Mu (µ) receptors; enkephalins, which bind primarily to Delta (δ) receptors and to a lesser extent to Mu (µ) receptors; and dynorphins, which bind primarily to Kappa (κ) receptors. Pain studies have shown that the central production of these endogenous peptides follows different pathways. While enkephalin production is more dispersed, endorphin production is primarily mediated by activity in the arcuate nucleus (ARC) of the hypothalamus, and activity in the parabrachial nucleus highly influences dynorphin production. Neurostimulation therapies can be employed for pain modulation to reduce or alleviate chronic, recurrent, and / or acute pain. For example, the device described herein can be used to treat chronic back pain, headache, migraine, cluster headache, pain due to temporomandibular joint disorder (TMD), pain due to endometriosis, menstrual pain and / or cramps (e.g., menstrual cramps, endometriosis, etc.).

[0009] Transdermal stimulation (TPS) devices can be used to induce neuronal plasticity, or neuroplasticity, to promote cognitive improvement, stroke recovery, post-traumatic stress disorder (PTSD), phobias, attention deficit hyperactivity disorder (ADHD), attention deficit disorder (ADD), dementia, including the treatment of Alzheimer's disease. Neuroplasticity is fundamental to learning; therefore, strategies to enhance neuroplasticity during training have the potential to significantly accelerate learning rates. Early research has successfully demonstrated that invasive or implantable vagus nerve stimulation (VNS) can drive strong, specific neuroplasticity. Brief bursts of VNS stimulation, combined with training, engage in pro-plasticity neural regulatory circuits and strengthen specific neural networks involved in learning. This can also be achieved non-invasively; for example, via stimulation of the ABVN and indirectly via stimulation of the ATN. This precise control over neuroplasticity, coupled with the flexibility to combine with virtually any training paradigm, allows for the stimulation of any of these neurons as a potential training paradigm for targeted neuroplasticity. For examples of cognitive impairment treatment, 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 for post-stroke rehabilitation, which can be performed with or without feedback. When feedback is used, it typically takes the form of a triggering mechanism. In some instances, the triggering mechanism may be an observer / trainee or a sensor such as a motion sensor and accelerometer, EEG, EKG, or EMG sensor.

[0010] The vagus nerve is one of the longest cranial nerves and can be located near the carotid artery in the neck (i.e., the cervical vagus nerve) along its trajectory. Direct stimulation of the vagus nerve activates the nucleus tractus solitarius (NTS), which projects to the basal ganglia (NBM) and locus coeruleus (LC). The NBM and LC are deep brain structures that release acetylcholine and norepinephrine, respectively, which are pro-plasticity neurotransmitters important for learning and memory. Vagus nerve stimulation using long-term implantable electrode sleeves has been safely used in humans to treat epilepsy and depression, and has been successful in clinical trials for post-stroke tinnitus and movement disorders. For examples of treatment for depression, see U.S. Patent No. 11,351,370, entitled “Apparatus and Method for Treating Cognitive Impairment and Depression with Electrical Stimulation.”

[0011] The ABVN ascends to the vicinity of the ear canal and, along its course, exposes itself via the mastoid canals (MsC, also known as Arnold's canals) to innervate several dermatome regions of the external ear, such as the cymba conchae and the interior of the tragus. Non-invasive stimulation of the ABVN may drive activity in brain-like regions, much like invasive vagus nerve stimulation. Recently, auditory nerve stimulation has been shown to be beneficial in the treatment of many human conditions.

[0012] Therapeutic devices can be designed to provide transdermal stimulation therapy to treat the same conditions as those treated with implanted and percutaneous devices. Transdermal stimulation therapy can be designed to restore impaired autonomic balance, for example, due to conditions such as heart failure, atrial fibrillation (AF), anxiety, stress, post-traumatic stress disorder (PTSD), gastric motility disorders, depression, cluster headaches, migraines, inflammation, and autoimmune diseases. Furthermore, these devices can be designed to accelerate blood clotting for faster hemostasis, for example, to help treat chronic conditions such as coagulation disorders; periodic conditions, such as periodic heavy bleeding, such as menorrhagia and / or heavy menstrual bleeding; and in acute situations, such as bleeding after a traumatic event or in surgical and postoperative situations, to minimize bleeding. Transcutaneous electrical stimulation of the tragus (e.g., the anterior eminence of the external ear), which is weakened by the auricular branch of the vagus nerve, can elicit evoked potentials in the brainstem of human subjects. Based on these observations, it is suggested that low-level transcutaneous VNS stimulation can suppress atrial fibrillation evoked potentials by stimulating the auricular branch of the vagus nerve at the tragus. Noninvasive percutaneous low-level VNS stimulation can increase the AF threshold (reducing AF risk) and alleviate the AF burden in mammals, including humans. In healthy subjects, percutaneous low-level VNS stimulation can also increase heart rate variability, increase parasympathetic tone, and / or reduce sympathetic outflow, effectively restoring parasympathetic / sympathetic balance.

[0013] Transdermal stimulation therapy devices can be used to reduce inflammation caused by viral or bacterial infections and other factors. In the initial stages of infection, the body's response includes the release of pro-inflammatory cytokines. In some cases, controlling this inflammatory response allows the inflammation to be reduced, helping the body heal more quickly. The inflammatory response is a double-edged sword, as it requires the elimination of cells infected by viruses and bacteria. However, an excessive pro-inflammatory response can actually lead to death. Particularly in respiratory infections, pro-inflammatory cytokines can lead to increased pathogen replication. Additionally, the accumulation of pro-inflammatory cytokines can impair lung function. Studies have shown that pro-inflammatory responses are often excessive in some individuals, such as the elderly. In many such cases, it is this pro-inflammatory response that causes more harm than the infection itself, potentially leading to death in the infected subject. For example, the body produces an excessive pro-inflammatory response in response to coronavirus disease 2019 (COVID-19) and severe acute respiratory syndrome (SARS). In fact, evidence gathered to date suggests that in some individuals with severe COVID-19, the body responds by exacerbating the release of pro-inflammatory cytokines. Reducing the inflammatory response, for example by decreasing circulating pro-inflammatory cytokines, will in some cases shorten healing time and / or reduce the duration for which infected individuals may require assisted respiratory therapy (such as mechanical ventilation). Generally, patients use ventilators for an average of no more than 5 days; however, in the case of COVID-19, patients use ventilators for much longer, up to 3 or 4 times longer; i.e., 15 to 20 days. Medical centers are typically equipped with sufficient ventilators to serve populations that will require such ventilators for an average of less than 5 days. The increased time COVID-19 patients require ventilators is a contributing factor to overall COVID-19 mortality, as many patients who need ventilators will not be able to access them. By modulating NTS activity, the therapeutic devices and methods described herein can not only a) increase bronchial tissue compliance, ultimately providing more oxygen to the body, but also b) alleviate inflammation by reducing circulating pro-inflammatory cytokines throughout the body, including the lungs. These two effects enable the novel therapeutic devices and methods described herein to serve as adjunctive therapies for respiratory infections such as Middle East respiratory syndrome coronavirus (MERS), severe acute respiratory syndrome (SARS), COVID-19, or chronic obstructive pulmonary disease (COPD).

[0014] Bronchial compliance arises via modulation of the autonomic lung pathway. Specifically, the novel therapeutic stimulation proposed in this paper involves the ABVN and / or auriculotemporal nerve (ATN) projecting to the NTS. The NTS projects to the LC, PAG, and RN (e.g., NRM). These brainstem nuclei deliver inhibitory signals to airway-associated ganglion-preganglionic neurons located in the nucleus fuzzus (NA). The NA signals airway smooth muscle via efferent pathways primarily through the vagus nerve, causing bronchodilation.

[0015] Anti-inflammatory effects are provided via activation of anti-inflammatory pathways (also known as cholinergic anti-inflammatory pathways). Specifically, the novel therapeutic stimuli described herein are the ABVN and / or ATN, which project to the NTS as previously mentioned; these projections induce cholinergic anti-inflammatory effects via efferent pathways, primarily through the vagus nerve. Systemic anti-inflammatory responses can be used to treat and / or prevent sepsis, one of the most expensive and highly fatal conditions. Another inflammatory condition that can be treated with a systemic anti-inflammatory response is pancreatitis. Pancreatitis is an 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 mediates spleen function, thereby reducing the amount of circulating pro-inflammatory cytokines. In addition, local anti-inflammatory effects occur in organs reached by efferent pathways; for example, in the lungs, intestines, and heart. In addition, the regulation of spleen activity can alter platelet counts, thereby causing clotting to occur more rapidly. This can also occur in the presence of coagulation disorders such as hemophilia A, B and C, as well as other coagulation factor deficiencies such as deficiencies of factor I, factor II, factor V, factor VII, factor X, factor XII and factor XIII. Furthermore, this can also occur in the presence of other coagulation disorders such as VWD.

[0016] For the reasons mentioned above and beyond, the rapid production of effective and low-cost transdermal neurostimulation devices could bring significant medical benefits to a wide population. The inventors recognize the need to develop new manufacturing techniques and stimulation delivery mechanisms to improve usability and thus treatment adherence, reduce manufacturing costs, and increase production yield, thereby enabling patients expressing the aforementioned conditions, as well as other conditions and symptoms from which transdermal neurostimulation therapy may benefit, to more broadly achieve symptom relief and / or improved medical conditions. Summary of the Invention

[0017] The inventors recognized the need for seamless integration of medical devices with desired form factors in wearable devices. They achieved this integration by using a flexible wearable body of the wearable medical device as a substrate for the printed circuit (PC), thereby integrating the electronic components of an electrooculography modulator into a three-dimensional (3D) circuit on the geometry of the wearable device. This offers several advantages compared to commonly used methods of integrating electronic and mechanical components. In conventional methods, rigid, flexible, or rigid-flexible printed circuit boards (PCBs) are miniaturized as much as possible and then inserted into a housing, which can be the wearable device itself. Interconnections between the PCB and the wearable device are one of the most common points of failure; they are often made very robust, increasing cost, weight, and size. Additionally, user interfaces such as buttons or LEDs often need to be close to or flush with the outer surface of the wearable device. This is typically achieved using additional components such as light tubes and connecting rods from the circuitry to the surface. In many cases, even with such connecting components, the PCB layout is still determined by the desired positioning of the user-interfacing components, which is determined by the wearable device and rarely aligned with the optimal positioning of such components within the PCB. Therefore, the positioning of user interface components imposes constraints on PCB layout. Furthermore, user interface components are typically the largest components on a circuit today, which significantly limits PCB miniaturization. Additionally, even with flexible or rigid-flexible PCBs, the circuitry can be bent but not stretched. Each of these limitations can be eliminated through the embodiments described herein.

[0018] On one hand, this disclosure relates to design and manufacturing techniques for creating wearable auditory nerve stimulators (WANS) having integrated three-dimensional (3D) electronic circuitry of electronic components, including at least two electrode assemblies for delivering neural stimulation. The WANS may include at least one earpiece assembly portion manufactured using flexible and / or stretchable materials, such as plastics, rubber, silicone, polyethylene terephthalate (PET), thermoplastic polyurethane (TPU), nonwoven polypropylene, etc. For example, the earpiece assembly portion may be molded or 3D printed. One of the earpiece assembly portions has a desired morphology constructed in its surface area to position each electronic component of the three-dimensional circuitry in a horizontal and / or vertical position best suited to the electronic component. For example, a button assembly may be provided with a terrain-covered area disposed near one of the surfaces of the molded portion. Traces between the electronic components may be printed using conductive ink, which allows the substrate on which they are printed to flex and stretch, thereby connecting the electronic components mounted at their different terrain surface locations to the electronic circuitry. In some embodiments, a dielectric layer is deposited over all traces and / or electronic components. In some embodiments, the second earpiece assembly portion is configured as a cover to seal the earpiece assembly of the WANS. The cover may be molded or 3D printed, for example, using one or more flexible materials. In some embodiments, a more conventional PCB (e.g., a rigid-flex PCB) may be combined with printed 3D structured circuitry to provide 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. Using a primary battery may be preferred when designing a completely disposable WANS.

[0020] In some embodiments, the WANS has a rechargeable battery. For example, the battery may be designed to be recharged via electromagnetic induction. In another instance, the rechargeable battery may be charged via a temporarily connected cable.

[0021] In some embodiments, the WANS is completely sealed to prevent water and dust from entering. For example, the outer cover may provide a waterproof or water-resistant surface seal.

[0022] On one hand, this disclosure relates to an independent otoelectric nerve modulator configured to be placed around the wearer’s ear such that surface electrodes are positioned for electrical stimulation of one or more branches of the vagus nerve and / or trigeminal nerve to provide therapy to the wearer.

[0023] In some embodiments, the otoelectric neuromodulator is configured to be placed around the wearer's ear, wherein at least one electrode assembly (e.g., at least one vagus nerve stimulation electrode) is adjacent to a branch of the vagus nerve. In one example, at least one vagus nerve stimulation electrode may be positioned at the location for stimulating the auricular branch (ABVN) of the vagus nerve. For example, the ABVN can be targeted by positioning one or more vagus nerve stimulation electrodes to contact the tragus of the wearer's ear. In another example, one or more vagus nerve stimulation electrodes may be positioned to contact the cymba conchae of the wearer's ear. In yet another example, one or more vagus nerve stimulation electrodes may be positioned to contact a piece of skin behind the wearer's ear (e.g., auricular skin, scalp skin, or both), wherein the piece of skin is adjacent to the mastoid canaliculi (i.e., Arnold's canals) through which the ABVN is exposed from the temporal bone. In yet another example, the ABVN can be targeted by positioning one or more vagus nerve stimulation electrodes to contact the posterior surface of the ear canal of the wearer's ear. Because the ABVN has branches connecting to the posterior auricular nerve, in yet another instance, the ABVN can be indirectly activated by stimulating the posterior auricular nerve. In this instance, one or more vagus nerve stimulation electrodes can be positioned in contact with the skin behind the ear and / or the scalp adjacent to the posterior auricular nerve pathway.

[0024] In some embodiments, the electrooculography (EOG) neuromodulator is configured to be placed around the wearer's ear, wherein at least one electrode assembly (e.g., a trigeminal nerve stimulation electrode) is adjacent to a branch of the auriculotemporal nerve (ATN). In one example, the ATN can be targeted by placing one or more trigeminal nerve stimulation electrodes on the facial skin in front of the patient's ear. For example, the facial skin may be positioned to cover or be adjacent to the temporomandibular joint. In another example, the ATN can be targeted by placing one or more trigeminal nerve stimulation electrodes to contact the anterior portion of the wearer's ear canal, through which branches of the ATN (e.g., the external auditory canal nerve) travel.

[0025] In some embodiments, the otoelectric neuromodulator is configured to be placed around the wearer's ear, wherein at least one electrode component of its electrode assembly (e.g., an ABVN stimulating electrode) is adjacent to the location where the ABVN is exposed via the MsC. Many researchers have used different approaches to target the ABVN through the ear canal, concha, and tragus. However, modulating ABVN activity (directly or indirectly) while the ABVN is exposed via the MsC is a novel concept offering significant advantages in terms of availability and manufacturability.

[0026] The foregoing general description of the illustrative embodiments and the following detailed description thereof are merely exemplary aspects of the teachings of this disclosure and are not limiting. Attached Figure Description

[0027] The accompanying drawings, which are incorporated in and form part of this specification, illustrate one or more embodiments and, together with the description, explain these embodiments. The drawings are not necessarily drawn to scale. Any dimensions accompanying the drawings and any values ​​illustrated in the 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 be omitted to aid in the description of basic features. In the drawings:

[0028] Figure 1 This is a block diagram of an exploded view of the components of an example wearable otostimulator (WANS) device;

[0029] Figures 2A to 2G The example three-dimensional form, printed circuit system, and additional electronic devices for forming the example WANS device are shown.

[0030] Figure 3 An example 3D printed flexible circuit system for WANS devices is shown;

[0031] Figure 4 An example cover for WANS devices is shown;

[0032] Figure 5 An example adhesive area layout and protective pad positioning for the skin-facing external surface of a WANS device are shown;

[0033] Figure 6 A sample assembled WANS device is shown;

[0034] Figure 7A and Figure 7B An example method for manufacturing WANS devices with three-dimensional printed flexible circuit systems is demonstrated.

[0035] Figures 8A to 8D , Figure 9 and Figure 10 This demonstrates an example of a targeted neural region used in therapy guided by the WANS device;

[0036] Figure 11 An example WANS device is shown, comprising two ear units connected by a strap;

[0037] Figure 12 A block diagram showing the components of an example pulse generator that communicates with an example ear therapy device;

[0038] Figure 13A The second example of a assembled WANS device is shown;

[0039] Figure 13B Showing Figure 13A Internal components of an example WANS device;

[0040] Figures 14A to 14D A cross-sectional view of a sample WANS is shown, illustrating the finite degrees of freedom of movement of the electronic components; and

[0041] Figures 15A to 15C A detailed view of the internal components of the second example WANS device is shown. Detailed Implementation

[0042] The following description, taken in conjunction with the accompanying drawings, is intended to illustrate various illustrative embodiments of the disclosed subject matter. Specific features and functions are described in conjunction with each illustrative embodiment; however, it will be apparent to those skilled in the art that the disclosed embodiments can be practiced without each of these specific features and functions.

[0043] Throughout this specification, references to "one embodiment" or "an embodiment" mean that a particular feature, structure, or characteristic described in connection with an embodiment is included in at least one embodiment of the disclosed subject matter. Therefore, the appearance of the phrase "in one embodiment" or "in one embodiment" throughout the specification does not necessarily require reference to the same embodiment. Furthermore, a particular feature, structure, or characteristic may be combined in any suitable manner in one or more embodiments. Further, it is intended that the embodiments of the disclosed subject matter cover modifications and variations thereof.

[0044] It must be noted that, as used in the specification and appended claims, the singular forms “a / an” and “the” include plural indicators unless the context clearly indicates otherwise. That is, unless otherwise expressly stated, as used herein, the words “a,” “an,” and “the” have the meaning of “one or more.” Furthermore, it should be understood that terms such as “left,” “right,” “top,” “bottom,” “front,” “rear,” “side,” “height,” “length,” “width,” “upper,” “lower,” “inner,” “outer,” “next,” and “external” as used herein describe reference points only and do not necessarily limit the embodiments of this disclosure to any particular orientation or configuration. Similarly, terms such as “first,” “second,” and “third” identify only one of the many parts, components, steps, operations, functions, and / or reference points disclosed herein, and likewise, do not necessarily limit the embodiments of this disclosure to any particular configuration or orientation.

[0045] In addition, the terms “approximately,” “about,” “close to,” “minor variation,” and similar terms generally refer to a defined value that includes a margin of 20%, 10%, or preferably 5% in some embodiments, as well as a range of values ​​in between.

[0046] All functionalities described in connection with one embodiment are intended to be applicable to other embodiments described below, unless expressly stated or incompatible with the other embodiments. For example, where a given feature or function is expressly described in connection with one embodiment but not expressly mentioned in connection with other embodiments, it should be understood that the inventors intend that the feature or function can be deployed, utilized, or implemented in connection with other embodiments, unless the feature or function is incompatible with the other embodiments.

[0047] Figure 1 This is an exploded block diagram of the components of an example wearable auditory nerve stimulator (WANS) device 100, which has an integrated three-dimensional printed circuit system for advantageously positioning the circuit system components in a compact and convenient arrangement. As shown, the WANS device 100 includes a body 102, a printed circuit system 104 deposited on the body 102, a set of electronic components 106 added to the printed circuit system 104 at printed connection points, a cover 108 for encapsulating the printed circuit system 104 and the electronic components 106 within the body 102, and a conductive adhesive (e.g., hydrogel or dry material, such as FLEXcon from FLEXcon Company, Inc. of Spencer, MA) configured to transfer energy from the WANS device 100 to the wearer's skin. ® 110, 112, a non-conductive adhesive (e.g., a hydrocolloid or dry skin adhesive) for increasing the adhesion between the WANS device 100 and the wearer's skin, and one or more pads 114 for protecting the adhesive elements before wearing.

[0048] In some embodiments, the body 102 is a flexible and / or stretchable wearable substrate designed to comfortably conform to the wearer's contours. The body 102 can be formed, for example, from rubber, plastics (e.g., PET, TPU, nonwoven polypropylene, etc.) and / or silicone. In some instances, the body 102 can be three-dimensionally printed and / or molded. The body 102 can, for example, be formed as a continuous molding of a single material. In another instance, the body 102 can be formed from two or more materials, for example, using a layered or two-step process. As shown, the body 102 includes multiple surface holes and protrusions for enabling the printing and / or positioning of the circuit system 104 along a three-dimensional surface.

[0049] Go to Figure 2AThe first example WANS wearable body segment 200 can be considered to include a front portion 202a, a rear portion 202b, and an ear loop portion 202c, each portion including at least one opening 204a-c for electrodes. When worn by a wearer, the WANS can be wrapped around the ear such that the front portion 202a is positioned in front of the ear and the rear portion 202b is positioned behind the ear. The ear loop portion 202c, connected to the front portion 202a via a flexible connector 206, can be friably and / or adhesively retained in the sacrum region of the ear. In some embodiments, the ear loop portion 202c is formed of a different material than the front portion 202a and the rear portion 202b. For example, the ear loop portion 202c can be designed to exhibit different characteristics than the front portion 202a and the rear portion 202b, such as deformability, adhesion, and / or different levels of flexibility in some instances.

[0050] In some embodiments, one or more protrusions are developed into the material of the wearable body segment 200. For example, the front portion 202a includes a set of protrusions 208a-m. In another example, the rear portion 202b includes protrusions 208n and a circular wall feature 212. While most protrusions 208 are typically rectangular or circular in shape, in other embodiments, the protrusions can be formed from a variety of geometries. In some instances, certain protrusions may be provided to mount or position certain circuitry components closer to the outer surface of the WANS device, such as LEDs, control buttons, and / or sensors in some instances. For example, when therapeutic electrodes are deposited on the skin-facing surface of the WANS, any control buttons may be placed near the more accessible surface of the WANS for ease of use. For example, some protrusions 208 may be formed as landing areas for picking up and placing circuitry components. Some protrusions 208 may be partially formed to support the separation of the body segment 200 from a corresponding cap or other body segment, for example, to protect the circuitry components from being crushed during use. At least some of the protrusions 208, such as protrusions 208h and 208i, may be formed with angled sides such that they do not form 90-degree angles if circuitry traces are deposited or flexible circuitry traces rise along protrusions 208h and 208i. Angles (e.g., up to 80°, up to 70°, about 45°, etc.) can be selected to deposit smooth electrical traces and / or enhance the durability of the traces (e.g., deposited electrical traces and / or flexible circuitry traces). Different protrusions 208 may be formed using different materials and / or printing compositions to enhance the properties of the protrusions. For example, some protrusions 208 may be designed to be substantially flexible (e.g., the same or similar in flexibility as the body section 200), while other protrusions 208 may include reinforcing materials or components to enhance rigidity. In some instances, protrusions designed to support heavier electronic components and / or maintain separation between the body section 200 and a second body section or cover may be printed to incorporate enhanced rigidity. In some instances, the protrusions may be deposited in an aspect ratio designed to support electronic components at a desired height while substantially maintaining the position of the electronic components and / or preventing breakage due to stress on the protrusions.

[0051] In some embodiments, one or more holes are developed into the material of the wearable body segment 200. For example, the front portion 202a includes a set of holes 210a-f. For example, some holes 210 can provide positioning for electronic components that require additional vertical space between the body segment and a corresponding cover or other body segment, such as capacitors, sensor components, power supply components, processing circuitry components, memory components, and / or functional subunits such as flexible, flexible-rigidified circuitry, or rigid-flexible circuitry in some instances. In another instance, some holes 210 can provide tight and / or precise positioning of electronic components. Furthermore, at least a portion of the holes 210 can provide positioning close to the area of ​​interest. For example, holes 210 can be created to position temperature sensors, acoustic sensors, electrocardiogram (ECG) sensors, and / or vibration sensors near the skin for better collection of biometric data. In yet another instance, at least a portion of the holes 210 can provide a collection area for placing adhesive used to secure larger electronic components to the wearable body segment 200. For example, electronic components can be placed onto the adhesive area before printing three-dimensional circuitry traces.

[0052] In some embodiments, the wearable body segment 200 includes one or more port areas for connecting to circuitry within the WANS. For example, the wearable body segment 200 includes port 214, which is provided to electrically connect external circuitry (e.g., charging devices, control devices, one or more tethered sensors, etc.) to the WANS. In other embodiments, port 214 is provided as a routing channel for routing 3D-printed circuitry to other areas of the WANS, such as external locations.

[0053] return Figure 1 In some embodiments, the printed circuit system 104 deposited on the body 102 is printed using conductive ink, which allows the substrate on which the circuit system traces are printed to flex and stretch, thereby connecting electronic components 106 mounted at various topographical surface locations on the body 102 to the printed circuit system 104. In some instances, the printed circuit system 104 may include connection traces, logic components, electrodes, and / or conductive pads for receiving electronic components. In some cases, the electronic components may include assembled rigid-flexible circuitry.

[0054] Figure 3 An example layout of a printed circuit system 300 for another WANS device is shown. Go to... Figure 3 The printed circuit system 300 includes a front portion 302 (e.g., similar to...). Figure 2DThe layout of the printed circuit system shown is as follows: front portion 202a, upper rear portion 304a, and lower rear portion 304b. The upper rear portion 304a includes an electrode 306a connected to a mating electrode 306b on the front portion 302. The lower rear portion 304b includes an electrode 308a connected to a mating electrode 308b on the front portion 302. The front portion 302 also includes an electrode 310.

[0055] Go to Figure 2B , Figure 2A A partial view of the wearable body segment 200 shows the printed circuitry system deposited on the front portion 202a and the earpiece portion 202c. As shown, traces extend along each protrusion 208a-m to electrical contacts (e.g., electrical contacts 226a-n) deposited thereon. Furthermore, the same partial view of the wearable body segment 200 is reproduced in... Figure 2C This includes the labels referencing orifices 210a-e. As shown, orifice 210c includes two electrical contacts 228a and 228b deposited therein. Similarly, orifice 210e has two electrical contacts 228c and 228d deposited therein, and orifice 210f has two electrical contacts 228e and 228f deposited therein.

[0056] like Figure 2B and Figure 2C As shown, the first electrode pair 220a, 220b is deposited on the ear canal portion 202c (e.g., deposited on...). Figure 2A The electrode pads 222b of the second electrode pair (e.g., between the front portion 202a and the rear portion 202b) are positioned above the opening 204c of the front portion electrode and between the front portion 202a and the front portion 202a. Figure 2A On the opposite side of the opening 204a. For example, the electrode pair can be positioned to contact the drive circuit system to deliver therapeutic pulses via electrodes (e.g., 220a and 224).

[0057] Although shown as a single-layer printed circuit system, in other embodiments, multiple layers can be developed, for example by depositing additional flexible material of the wearable body segment 200 on top of at least a portion of the first layer of printed circuit system and / or dielectric material layer. In other embodiments, a second layer of circuit system can be deposited in the corresponding wearable body segment 200 (e.g., similar to...). Figure 1 (The cover 108), and when the first main body section and the second main body section are pressed together, the circuit system layer can be connected.

[0058] return Figure 1In some embodiments, various electronic components 106 are added to the printed circuit system 104. In a first example, electronic components 106 may include motion sensor components, such as one or more accelerometers and / or gyroscopes (e.g., MEMS gyroscopes) for tracking the wearer's movement and / or orientation in some instances. For example, a gyroscope could be used to determine when the wearer is not in a generally vertical orientation, such as a disoriented pilot who may not be aiming along the horizon, in order to apply stimulation to treat motion sickness. Similarly, an accelerometer could be used to determine when the pilot's body is subjected to gravitational forces that may cause motion sickness. In other illustrative examples, motion sensors could be used to identify involuntary movements of the wearer, such as body twitches / tremors, or to track the wearer's activities (e.g., daily exercise). In a second example, electronic components 106 may include one or more readily available biometric monitoring electrical sensors, vibration sensors, and / or acoustic sensors to identify the wearer's biometrics (e.g., pulse, heart rate, etc.). For example, biometrics could be used as feedback to control therapy (e.g., starting, adjusting, and / or ending). In a third embodiment, electronic component 106 may include a power source, such as a battery. In a fourth embodiment, electronic component 106 may include input / output (I / O) devices, such as, in some embodiments, 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 connecting external devices. For example, external devices may be controllers, such as stimulators, and / or external power supplies.

[0059] In some implementations, electronic component 106 includes one or more integrated circuits (ICs) and / or printed circuit boards (PCBs). In some instances, the PCB may be used to add a boost converter to control impedance at critical locations in the circuitry. In another instance, the PCB may include a quad flat no-lead (QFN) package for heat dissipation. In yet another instance, a Bluetooth IC module or other wireless transceiver may be added to provide wireless communication between WANS device 100 and a controller and / or individual WANS devices, such as WANS devices designed as pairs to coordinate the delivery of therapy to both the wearer's right and left ears.

[0060] In some embodiments, wireless communication enables the WANS to communicate with sensors. In some cases, the sensors can provide feedback signals to adjust or control the therapy provided by the WANS. For example, a biosensor assessing cortisol concentration in the skin can provide signals to determine a user's stress level. In another case, sensors can be used to assess electromyography (EMG) activity and provide early detection of intent to activate muscles, or motion sensors can provide information about limb movement. For example, in both cases, sensor signals can be used as triggers for stroke recovery training programs. In yet another instance, sensors providing pupillary measurements can be used as measures of attention, alertness, or wakefulness (or lack thereof). Such signals can be used as feedback to adjust therapy to maintain desired levels of attention, alertness, and / or wakefulness. Similarly, in another instance, attention, alertness, and / or wakefulness can be assessed by an ultrasound sensor measuring cerebral blood flow velocity (CBFV). In such instances, CBFV can be used as feedback to adjust therapy.

[0061] In some implementations, robotic pick-and-place fabrication is used to add at least a portion of electronic components 106 to printed circuit system 104. For example, a robotic system can use coordinate placement programmed based on printed coordinates to align electronic components 106 with contact pads printed for each electronic component 106. In another instance, an automated system can use sensors to detect the coordinates of printed contact pads to add various electronic components 106.

[0062] In some embodiments, at least a portion of the electronic component 106 is soldered in place. For example, manual or robotic soldering can be performed to connect certain electronic components 106. In some embodiments, at least a portion of the electronic component 106 is attached to the printed circuit system 104 using conductive epoxy resin. In other embodiments, at least a portion of the electronic component 106 is assembled in place using pins, snaps, or other mechanical connectors to permanently or releasably secure each electronic component 106 to its appropriate location on the printed circuit system 104. In some embodiments, heat and / or ultraviolet (UV) curing provides sufficient attachment of certain electronic components 106 to the printed circuit system 104 (e.g., printed pads).

[0063] Go to Figure 2D When the electronic components are first added to the forward section 202a, a set of electronic components 230a-f has been installed to the protrusions 208a-k. Furthermore, electronic components 232a and 232b have been added to the holes 210d and 210e.

[0064] Go to Figure 2EWhen electronic components are added for the second time in the forward section 202a, a PCB or IC 234, an input control 236 with a button 238, and an LED 240 are added to the area including holes 210a, 210b and 210d, electrode 224, and electrode pairs 222 and 220b.

[0065] exist Figure 2F The top view of the WANS wearable body segment 200 shows the complete circuit system, including the placement of additional electronic components. As shown, the rear portion 202b includes a power supply element 242 (e.g., a coin cell battery). To connect to the power supply element 242, such as... Figure 2B As shown, the inclined protrusion 244 provides an angled surface for depositing traces of the printed circuit system, thereby avoiding right-angle or similarly narrow angles (e.g., greater than 85°, greater than 80°, greater than 75°, etc.) that may be more easily damaged or broken.

[0066] return Figure 1 In some embodiments, after the circuitry deposition 104 and circuitry addition 106 in the body segment 102 are completed, a cover 108 may be added to encapsulate the printed circuitry 104 and electronic components 106 within the body 102. As shown, the cover 108 may be formed as a cap or lid extending substantially downward along the side of the body segment 102. In other embodiments, the cover 108 may at least partially wrap around the body segment 102, for example, to increase water resistance and / or to increase retention. The cover 108 may be formed of the same or different material as the body segment 102. For example, the cover 108 may be molded or three-dimensionally printed using one or more flexible materials. In some embodiments, the cover 108 is overmolded onto the body segment 102. The overmolded cover 108 may be formed using one or more flexible materials, the same or different from the material of the body segment 102. The cover 108 may include one or more openings for the passage of I / O electronic components, such as, in some instances, one or more buttons, power cord connectors, controller connectors, and / or LEDs. The cover may further include an opening allowing skin to contact one or more electrodes. In some embodiments, the cover 108 includes one or more transparent areas, for example, to allow visual indicators such as LEDs to pass through. Figure 4 ,For example Figures 2A to 2G The cover 400 of the main body section 200 includes a connector port 402, an LED port 404, and a button control port 406.

[0067] return Figure 1In some embodiments, a conductive adhesive 110 is added at the electrode locations on the back side of the body segment 102 of the WANS 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 locations, in some embodiments, the conductive adhesive may be deposited on the front side of the cover 108 and the rear side of the body segment 102. In some embodiments, the conductive adhesive 110 is a conductive double-sided tape manually or automatically positioned above the electrode locations on the WANS device 100. In some embodiments, the conductive adhesive 110 is three-dimensionally printed onto the segments of the WANS device 100. In embodiments using oriented conductive epoxy, since oriented conductive epoxy is conductive only in the Z direction when cured under a magnetic field, the epoxy can be provided over a wider surface (e.g., across multiple electrodes or otherwise substantially coating the skin contact surface of the WANS device 100).

[0068] Go to Figure 5 The WANS device 500 includes a front portion 502 and a rear portion 504. The front portion includes a conductive adhesive region 510, and the rear portion includes conductive adhesive regions 506 and 508. The conductive adhesive region 510 of the front portion 502 may, for example, correspond to... Figure 3 The electrode 310 of the circuit system 300. Similarly, the conductive adhesive region 506 can correspond to Figure 3 The electrode 306a, and the conductive adhesive region 508 can correspond to Figure 3 Electrode 308a.

[0069] In some embodiments, the conductive adhesive region 510 is configured to contact the wearer's skin in the region of the neural structures of the auricular-temporal electrode (ATN) and / or the neural structures connected to the ATN, such that delivery of therapeutic stimulation via the conductive adhesive region 510 modulates ATN activity. [Go to...] Figure 8A and Figure 8B ATN 802 is 800 degrees relative to the human ear. Figure 8A ), usually running 80 degrees in front of the ear, and bony ( Figure 8B The description is relative to ear canal 810. In one illustrative example, the electrodes (which are in electrical communication with conductive adhesive region 506) Figure 3 Electrode 308a) can be positioned close to the temporomandibular joint.

[0070] In some embodiments, the conductive adhesive region 506 is configured to contact the wearer's skin in areas of neural structures of the auricular branch of the vagus nerve (ABVN) and / or neural structures connected to the ABVN, such that delivery of therapeutic stimulation via the conductive adhesive region 506 modulates ABVN activity. For example, as... Figures 8A to 8D As shown, ABVN 804 is presented via papillary canaliculi (MsC) 812 (e.g., Arnold canals) Figure 8D And relative to the ear 800 ( Figure 8A ), relative to ear canal 810 ( Figure 8B And relative to the back of the ear ( Figure 8C (Revealed.) Go to Figure 9 The posterior auricular nerve 900 encounters a branch of the ABVN, thus providing another target for ABVN stimulation. In an illustrative example, electrodes that are electrically communicated with the conductive adhesive region 506 ( Figure 3 The electrode 306a) can be positioned close to MsC.

[0071] In some embodiments, the conductive adhesive region 508 is configured to contact the patient's skin as a loop electrode, thereby forming a circuit across the tissue, wherein the electrode corresponds to each of the front conductive adhesive region 510 and the rear conductive adhesive region 506. Although illustrated as a single loop electrode (e.g., region 508) for each positive electrode corresponding to adhesive regions 510 and 506, in other embodiments, a separate loop electrode may be provided for each positive electrode. In yet another embodiment, three or more loop electrode paths may be provided for the two positive electrodes. Other combinations are also possible.

[0072] Go to Figure 2F Similarly, conductive adhesive regions can be provided to create an electrical communication path in the anterior part of the ear canal from the electrode 220a of the wearable body segment 200 to the wearer's skin. (Go to...) Figure 10 Electrode 220a can be positioned, for example, to stimulate the external auditory canal nerve branch 1000 of ATN 802.

[0073] return Figure 1 In some embodiments, a non-conductive adhesive 112, such as a hydrocolloid, is applied to the WANS 100, typically surrounding each area of ​​the conductive adhesive 110. For example, such as Figure 5As shown, the non-conductive adhesive 112 can generally be disposed in regions 512a (e.g., around the conductive adhesive 510) and 512b (e.g., between the conductive regions 506 and 508, around region 508, and at least partially around region 506). The non-conductive adhesive 112 can be used, for example, to electrically isolate the conductive regions created by the 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 instances, the non-conductive adhesive 112 can be deposited (e.g., sprayed, three-dimensionally printed, etc.) on the front side of the lid 108 and the back side of the main body section 102. In some embodiments, the non-conductive adhesive 112 is a double-sided tape manually or automatically placed on the WANS device 100. In other embodiments, instead of using a non-conductive adhesive, a gripping material and / or pattern is molded into and / or three-dimensionally printed on the sections of the WANS device 100. For example, three-dimensional adhesive microstructures can be provided on the surfaces of the main body 102 and / or the lid 108 to increase the retention force of the WANS device around the wearer's ear.

[0074] In some embodiments, one or more liners 114 are placed over the adhesive regions (e.g., the conductive adhesive 110 and the non-conductive adhesive 112) to maintain the stickiness and cleanliness of the adhesive material before wearing. As Figure 5 shown, for example, the front liner 514a is shown covering the adhesive regions 510 and 512a of the front section 502, and the back liner 514b is shown covering the adhesive regions 506, 508, and 512b of the back section 504. In other embodiments, a single liner can be provided to cover all of the adhesive regions of the WANS.

[0075] Turning to Figure 13A , another example WANS device 1300 is shown. Similar to Figure 1 the first example WANS device 100, the WANS device 1300 includes a front portion 1302a, a back portion 1302b, and a lanyard portion 1302c. Compared to the internal view of the first example WANS device 100 presented in Figure 1 , the WANS device 1300 has replaced many of the smaller components of the WANS device 100 with the same or similar functionality, which is provided by a set of circuit components as shown in the flexible body portion 1304 of the WANS device 1300. For example, the circuit components can replace Figure 1 certain printed circuit system components of the first example WANS device 100. Additionally, certain circuit components can be integrated as described with respect to Figures 2A to 2GThe description pertains to one or more electronic components described with respect to WANS device 100. In some instances, the circuit components may include flexible circuit system printed circuit boards (PCBs), rigid-flexible PCBs, and / or rigidified flexible PCBs. Certain circuit components may be bent, flexed, and / or folded to create three-dimensional surface areas of the PCB, thereby allowing the circuit components to be optimally fitted within the three-dimensional structure of the flexible body portion 1302. Different circuit components may have different manufacturing types, such as based on the type and / or positioning of the circuit system. For example, components that need to be held in position (e.g., mechanical buttons or switches, LEDs, etc.) may be formed as less flexible (e.g., rigidified flexible) or rigid circuit components, while components in highly flexible areas (e.g., the portion of WANS device 1300 wrapped around an ear) and / or that need to be bent or folded to fit into assigned positions within WANS device 1300 may be manufactured as flexible circuit system components.

[0076] As shown in the figure, the front portion 1302a of the example WANS device 1300 includes an input circuit assembly 1306 with a mechanical control component (e.g., a push-button switch) 1308 on top. The flexible body portion 1304 includes a mounting platform 1310 for supporting the input circuit assembly 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 placed 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 to hold the mechanical control component 1310 positioned within the cover of the WANS device 1300 (e.g., Figure 13B On the surface of the cover (1350).

[0077] like Figure 15A As shown in the first detailed view 1500 of the WANS device 1300, the input circuitry assembly 1306 is electrically connected to the circuitry assembly 1312 via a three-dimensionally formed flexible circuitry system bridge 1502. For example, the flexible circuitry system bridging the components of the WANS device 1300 may include traces for each signal type carried by a particular device and power traces for delivering power throughout the components of the WANS device 1300. For example, the flexible circuitry system bridging assembly may be connected to other components (rigid-flexible, rigid-flexible, etc.) via pin connections.

[0078] In some embodiments, the circuit assembly 1312 of the front portion 1302a includes various circuit system components (e.g., resistors, capacitors, etc.) for supporting the functionality of the WANS device. The circuit assembly 1312 is electrically connected to the processing circuit system assembly 1314 via a flexible circuit system bridging assembly 1504.

[0079] In some embodiments, the circuit assembly 1312 is disposed on a circular (e.g., annular) cavity 1326a having one or more flexible protrusions extending therefrom and / or surrounding the cavity 1326a. For example, the cavity 1326a may accommodate and / or be surrounded by a plinth pattern, thereby allowing the circuit assembly 1312 to slide against the flexible protrusions during flexure of the WANS device 1300. For example, the flexible protrusions may additionally generate frictional forces that maintain the movement of the circuit assembly 1312 to a limited area. In one example, frictional elements may be generated at least in part by clamping the circuit assembly 1312 between two sets (e.g., an upper and lower set) of small flexible protrusions. In other embodiments, the frictional effect may be generated by the material type (e.g., viscous, sticky, etc.) and / or material finish (e.g., roughness and / or patterning) of the flexible protrusions. Figure 15A and Figure 15B As shown, cavity 1326a is surrounded by pillar 1506. The following text is relative to... Figures 14A to 14D The cavity 1326a and the protrusion are described in more detail.

[0080] In some embodiments, the processing circuitry system assembly 1314 (e.g., a microcontroller) controls the delivery of therapeutic nerve stimulation via electrodes from the front portion 1302a, the rear portion 1302b, and the ear loop portion 1302c. In some instances, the electrodes may be electrically connected to the processing circuitry system assembly 1314 via printed circuitry traces, extensions of one of the circuitry and / or flexible circuitry system assemblies, and / or pin connections to electronic components.

[0081] As shown, for example, pin 1340 extends through extension 1336 of processing circuit system assembly 1314 to connect at least one first electrode to processing circuit system assembly 1314. For example, extension 1336 may be a flexible circuit system extension of the printed circuit board of processing circuit system assembly 1314. Pin 1340 extends into an opening (e.g., a through-hole) 1338 in flexible body 1304. Figure 15A In the first detailed view 1500 of the WANS device 1300, the layout is shown more clearly. For example, electrodes can be generated by three-dimensional printing on the back side of the flexible body 1304 and then filling the openings 1338 with conductive ink to ensure electrical connection with the processing circuit system assembly 1314. For example, once the conductive ink has been deposited as electrodes and the vias filled, it can be cured.

[0082] In another example, the ear loop flexible circuit system (e.g., flexible circuit system, rigid-flexible circuit system, rigidified flexible circuit system, etc.) assembly 1344 is connected to the processing circuit system assembly 1314 to provide power and communication to one or more electrodes on or in electrical communication with the ear loop flexible circuit system assembly 1344.

[0083] In another example, the processing circuitry system component 1314 may be electrically connected (e.g., via printed circuitry system traces) to the electrodes of the rear portion 1302b. In some embodiments, the processing circuitry system component 1314 may be indirectly connected to other electrodes via another circuitry component, such as the power supply circuitry system component 1324 of the rear portion 1302b.

[0084] As shown in the figure, the output electronics assembly 1316 is mounted on top of the processing circuitry system assembly 1314. In some instances, the output electronics assembly 1316 may be a haptic feedback assembly, a speaker assembly, and / or a light-emitting assembly. For example, the output electronics assembly 1316 may be controlled by the processing circuitry system assembly 1314 to present a vibratory and / or audible alarm to the wearer, such as a low battery alarm or a therapy start alarm. In some embodiments, the treatment device includes one or more haptic feedback actuators located between electrode pairs. For example, the haptic feedback actuators may move in a repetitive pattern from a first position to a second position to mask the sensations felt by stimulating the electrodes. The haptic feedback actuators may be configured to isolate or electrically separate conductive shunts between the electrodes, such as between portions of a conductive gel.

[0085] In some embodiments, the processing circuitry system assembly 1314 and the lighting circuitry system assembly 1318 are positioned adjacent to each other within a rectangular cavity 1346. For example, the cavity may allow the connector of the processing circuitry system assembly 1314 to align with the bottom surface of the flexible body 1304, thereby avoiding unnecessary deflection of the flexible circuitry connector assembly 1342 or the loop flexible circuitry system 1344.

[0086] In some embodiments, the lighting circuitry system assembly 1318 provides luminous feedback to the user, such as indicating that the WANS device 1300 is powered on, has a low battery, and / or is currently in therapy. In some embodiments, the lighting circuitry system is supported by one or more protrusions (e.g., a post or base) such as a post 1322 to position the light-emitting device 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, the LEDs may be used to indicate the output intensity of the WANS.

[0087] Go to Figure 15BIn the second detailed view 1510 of the WANS device 1300, the lighting circuit system assembly 1318 is shown on a post 1322 (e.g., a base or platform), positioning the lighting circuit system assembly 1318 at a height closer to the output assembly 1316. As shown, a three-dimensional bent branch 1342a of the flexible circuit system connector assembly 1342 connects the processing circuit system assembly 1314 and the lighting assembly 1318 to the circuit system of the rear portion 1302b. Figure 13A As shown in the figure, the flexible circuit system connector assembly 1342 is connected to the power circuit system assembly 1324 or the transition circuit system assembly 1332 of the rear portion 1302b.

[0088] In some implementations, the power circuitry system assembly 1324 manages the power distribution to the circuitry and components of the WANS device 1300. As shown, the power circuitry system assembly 1324 is positioned above a circular (e.g., elliptical) cavity (e.g., a hole, recess) 1326b. In some embodiments, the circular cavity 1326b, smaller than the power circuitry system assembly 1324, can provide a limited range of movement for the power circuitry system assembly 1324. The power circuitry system assembly 1324 is in direct electrical communication with an inductor assembly 1328 located adjacent to the battery 1330.

[0089] Go to Figure 15C A third detailed view 1520 of the WANS device 1300 shows an inductor assembly 1328 connected to a power circuit system assembly 1324 via a flexible circuit system connector 1534. Specifically, the flexible circuit system connector 1534 is connected to an inductor circuit system assembly 1536, on which the inductor 1328 is mounted.

[0090] As shown, a battery 1330 (e.g., a button cell) is disposed in a rectangular cavity 1522. In some embodiments, the position of the battery 1330 is maintained by an adhesive deposited or otherwise placed in the cavity 1522.

[0091] In some implementations, three-dimensional printed traces are used to connect transition circuit system components 1332 (e.g., PCBs) to enable electrical communication between battery 1330, electrodes, and / or circuit components (e.g., components 1306, 1312, 1314, 1318, and 1324). For example, go to Figure 15CPrinted circuit system trace 1524 electrically connects transition circuit system assembly 1332 to the battery. A first portion of printed circuit system trace 1524a extends from transition circuit system assembly 1332, descends along an angled protrusion 1528a, along the lower surface of flexible body 1304, and descends along ramp 1526 into cavity 1522, in which the first portion is electrically connected to battery 1330. A second portion of printed circuit system trace 1524b exits the cavity via another ramp (not shown), extends along the lower surface of flexible body 1304, and along angled protrusion 1528b to transition circuit system assembly 1332.

[0092] In some embodiments, the transition circuit system assembly 1332 is also connected to the rear portion electrode via a through-hole 1530. The printed circuit system trace 1532 extends downwards from the transition circuit system assembly 1332 along another angled protrusion 1528c and across the through-hole 1530. Figure 15A As detailed in the description of pin 1340, electrodes can be printed on the outer surface of flexible body 1304 and via 1530 is filled with conductive material to establish an electrical connection between transition circuit system component 1332 and the electrodes.

[0093] Flexible circuit system bridge assemblies 1538 and 1540 connect transition circuit system assembly 1332 to power circuit system assembly 1324 and capacitor circuit system assembly 1334, respectively. Capacitor circuit system assembly 1334 may be provided to support power circuit system assembly 1324.

[0094] Go to Figure 14A A first detailed cross-sectional view 1400 shows a circuit assembly 1312 suspended above a cavity 1326a by a ring of a column assembly 1506. Additionally, an upper column assembly 1402 extends downward to connect with the circuit assembly 1312. For example, the upper column assembly 1402 may be formed on or integrated into a cover 1350 of the WANS device 1300. As shown, the upper column assembly 1402 surrounds an upper cavity 1404 within the cover 1350. When the flexible body 1304 is assembled with the cover 1350, the combination of the lower cavity 1326a and the upper cavity 1404 provides a surrounding cavity region in which limited movement of the circuit assembly 1312 is permitted. The column ring in the flexible body 1304 and the cover 1350... Figure 13B It is also visible in the perspective view of the WANS device 1300.

[0095] In some embodiments, the upper column assembly 1402 and / or the lower column assembly 1506 are deformable and flexible, allowing them to respond to lateral and compressive forces caused by flexure of the WANS device 1300. For example, turn to Figure 14BIn the second detailed cross-sectional view 1410, when the WANS device 1300 flexes in the region of the circuit assembly 1312, certain posts can flex at an angle (e.g., best shown by upper post 1402d and lower post 1506b). Furthermore, certain posts 1402 and / or 1506 can compress to accommodate the forces exerted by the flexing of the WANS device 1300.

[0096] In some implementations, forces applied to the WANS device 1300, including flexural, compressive, and / or gravitational forces, cause the circuit assembly 1312 to move back and forth (e.g., between the input circuit assembly 1306 and the processing circuit system assembly 1314). Go to Figure 14C and Figure 14D The comparative cross-sectional views 1430 and 1440 of the WANS device 1300 show an example range of lateral movement of the electronic component 1312.

[0097] Although described relative to electronic component 1312, it is generally Figures 14A to 14D The design shown can be extended to other layouts of one or more compressible / deformable / flexible upper elements and one or more mating compressible / deformable / flexible lower elements, which provide cavities for the assembly and allow a range of motion for the assembly due to pressure applied to the WANS device 1300. For example, the mobility retention feature provided by clamping the assembly between the upper and lower flexible elements can protect the connection from breakage and / or various aspects of the assembly itself from damage during use of the WANS device 1300.

[0098] exist Figures 14A to 14D In embodiments other than those shown, columns and / or cavities of different shapes and sizes may be used, such as those arranged in... Figure 13A The pillar is located within the elliptical cavity 1326b, below the power circuit system assembly 1324. In another embodiment, the cavity may not be provided. For example, instead, two raised areas may provide a "nest" for placing components.

[0099] Although shown as a rectangular block, in other embodiments, the column can be formed as a cylinder, hexagonal prism, or other shape. Furthermore, in some embodiments, the column can be conical (e.g., a circular or truncated pyramid or prismatic shape).

[0100] In some embodiments, the flexible material region can be cut or slit to provide movement, rather than a column. For example, a raised ring formed as, for instance, an annular shape can be cut into slits to allow flexure and / or bending. In other embodiments, a pair of matching solid flexible annular shape regions (e.g., body portion 1304 and cap 1350) can be provided to allow deformation during flexure or overhang, as well as some sliding maneuverability.

[0101] Figure 7A and Figure 7B Demonstrated the use of devices for manufacturing WANS, such as Figure 1 Device 100 Figure 5 Device 500 and / or Figure 13B The flowchart of example method 700 of device 1300.

[0102] In some embodiments, method 700 begins by creating a three-dimensional (3D) circuit system layout designed to incorporate electronic circuitry components within the volume of the WANS device, while advantageously positioning I / O components for user convenience. In some embodiments, a rigid or rigid-flexible PCB containing multiple electronic components is considered a single electronic component and thus incorporated into the WANS 3D circuit system layout. Furthermore, in some embodiments, a flexible circuit system connector comprising trace connections for transmitting signals from one circuit system component to another can be considered an electronic component. For example, computer-aided design software packages can be used to design the 3D circuit system layout.

[0103] In some embodiments, a flexible body portion (704) of the WANS device is formed, including protrusions and / or holes for supporting a three-dimensional circuit system layout. For example, the flexible body portion may be as relative to Figure 1 The main body 102 is produced as described. For example, protrusions and / or holes can be formed relative to... Figure 2A The protrusion 208 and / or hole 210 are produced in a manner similar to that described. The flexible body portion can be produced to have one or more openings for communication and / or access to I / O circuit elements of the therapeutic electrodes. For example, the openings can be similar to Figure 2A Opening 204. In some embodiments, one or more openings are formed in the flexible body portion after production. In some instances, one or more openings can be stamped or laser-cut from a molded or printed part.

[0104] In some implementations, conductive traces, therapeutic electrodes, and / or other printed circuit systems are deposited on the flexible body portion (706). For example, this can be as relative to... Figure 1 Printed circuit system 104, Figure 2B The printed circuit system and / or shown Figure 3 The printed circuit system 300 is deposited as described. The printed circuit system may include one or more therapeutic electrodes, such as... Figure 2B Electrodes 220a and 224, Figure 2F Electrode 222a and / or Figure 3Electrodes 306a, 308a, and 310. The printed circuit system may include one or more landing pads and / or connection components (e.g., Figure 2B Electrical contacts 226a-n are used to add one or more electronic components to a 3D circuit system, such as... Figure 1 Electronic component 106.

[0105] In some implementations, if any connection components and / or landing pads (708) are provided, at least one electronic component (710) is added at the location of the landing pads and / or connection components in the printed circuit system. Adding electronic components may include soldering, inserting, and / or attaching each component. Some components may be added automatically to the printed circuit system, while others may be added manually. For example, they may be added as relative to... Figure 1 Electronic components are added as described in electronic component 106.

[0106] In some implementations, any remaining electronic components are added to the 3D circuit system layout (712). For example, they can be added... Figure 13A The WANS device 1300 features a 3D circuit system layout for circuit components and flexible circuit system connectors.

[0107] In some implementations, a dielectric layer (714) is added over the printed circuit system and / or electronic components. In some instances, the dielectric layer may be printed, 3D printed, and / or sprayed onto the printed circuit system and / or electronic components. The dielectric layer may, for example, isolate the printed circuit system and / or electronic components from short circuits, crosstalk, and / or signal delays. The dielectric layer may further provide thermal conductivity to prevent overheating of the circuit system components.

[0108] In some embodiments where the three-dimensional circuit system layout includes two or more layers (716), one or more of the operations 706 to 714 can be repeated. For example, the added dielectric layer (714) can be used to isolate multilayer conductive traces, thereby allowing them to cross each other over different layers. Figure 2D and 2E As shown, for example, electronic components can be added in one or more layers on top of a printed circuit system. In another example, additional traces can be added after positioning certain electronic components to interconnect certain components and / or connect certain components to other features of the printed circuit system (e.g., electrodes, landing pads, etc.), such as traces 1524 and 1532 connected to transition component 1332, as... Figure 15C As shown. For example, after deposition traces 1524 and 1532, battery 1330 can be added (710) to... Figure 13A In the 3D circuit system layout of the WANS device 1300.

[0109] In some implementations, if the 3D circuitry layout includes an outer layer (718) on the outer surface of the flexible host portion, conductive traces, one or more therapeutic electrodes, and / or other printed circuitry systems are deposited onto the outer surface of the flexible host portion (720). For example, this can be done as relative to... Figure 13A and Figure 15C Electrodes are formed as described and vias 1338 and 1530 are filled.

[0110] In some embodiments, the cover is positioned on the flexible body portion to encapsulate printed circuit systems and electronic components (722). The cover may be formed of the same or similar material as the flexible body portion. In some instances, the cover may be molded, overmolded, and / or three-dimensionally printed. In some embodiments, the cover includes one or more features, such as one or more seals and / or drainage paths, for providing a water-resistant or waterproof seal to the flexible body portion. For example, the cover may be positioned with... Figure 1 The design is similar to that of the 108.

[0111] In some embodiments, the cover includes one or more openings, such as Figure 4 The cover 400 has openings 404 and 406. Positioning the cover may include aligning the openings of the cover with one or more features of a printed circuit system and / or electronic component. Go to Figure 6 The diagram shows a transparent, fully assembled WANS device 600 to illustrate... Figures 2A to 2E The positioning of the various components and circuit systems shown. As shown, button 238 and LED 240 are connected by a cover (e.g., Figure 4 The opening in the cover 400 is exposed. In other embodiments, the material of the cover is made thinner in certain areas so that when illumination is provided without an actual opening, for example, LED 240 or multiple LEDs can be seen through the remaining thickness of the cover material, thereby maintaining the internal seal of the WANS.

[0112] Go to Figure 7B In some embodiments, a conductive adhesive (724) is added at the location of one or more therapeutic electrodes. Additionally, as relative to... Figure 3 and Figure 5 The electrodes discussed may include loop electrodes. For example, they may be relative to... Figure 1 The conductive adhesive is added in one or more of the manner described in the conductive adhesive 110. Although described with respect to the flexible portion, in some embodiments, the conductive adhesive may be added at the location of one or more electrodes aligned with the cover of the WANS device.

[0113] In some implementations, a non-conductive adhesive is added substantially around the location (726) of one or more conductive adhesive regions. For example, it can be relative to... Figure 1 The non-conductive adhesive is added in one or more of the ways described in Non-Conductive Adhesive 112. The non-conductive adhesive may partially or completely surround the conductive adhesive, as relative to... Figure 5 As described and shown. Although illustrated with respect to the flexible portion, in some embodiments, a non-conductive adhesive may be added around one or more conductive adhesive regions added to the cover of the WANS device.

[0114] In some embodiments, the adhesive area of ​​the WANS device (e.g., conductive and / or non-conductive) is covered by one or more protective pads (728). The pads can maintain the adhesive quality and cleanliness of the adhesive area of ​​the device until the device is worn. For example, they can be as relative to... Figure 1 Pad 114 and / or Figure 5 The gaskets 514a and 514b described herein provide gaskets. In another instance, such as Figure 6 As shown, a front pad 602a, a rear pad 602b, and an in-ear portion pad 602c are provided to cover the adhesive portion.

[0115] In illustrative examples, such as Figure 1 The therapeutic device, such as device 100 or device 1300 of Figure 13, can be worn as follows. In embodiments with protective pads on the skin adhesive and / or electrodes, the protective pads are removed before use. The auricular assembly is applied around the patient's auricle and pressed against the patient's skin, such that the exposed skin adhesive and adhesive / hydrogel (or other conductive adhesive) adhere to the skin. Next, the ear hook assembly is placed in the ear, such that at least a portion of the ear hook is positioned in a cavity outside the external auditory canal and / or engages with the cymba conchae of the ear.

[0116] Electrodes can be made larger or combined, such that multiple electrodes are combined into a large contact, such as contact pads 804a, 804b, and 804c. In some embodiments, the treatment device includes a set of electrodes configured to be virtually grouped together to form one or more effective electrodes. For example, a first set of electrodes may correspond to electrode 804a, a second set of electrodes may correspond to electrode 804b, and a third set of electrodes may correspond to electrode 804c. Grouping smaller electrodes can provide multiple electrodes, each with its own independently controlled current source, allowing current control and thus providing better spatial resolution and targeting capability. Electrodes can be virtually grouped through a processing circuit system.

[0117] Although method 700 is described relative to a particular series of operations, in other embodiments, method 700 may include more or fewer operations. For example, in other embodiments, instead of the positioning cap (722), a second flexible body portion may be created, which is designed to cooperate with the first flexible body portion to complete the connection of a shared circuit system between the flexible body portions. In some embodiments, one or more operations in the operation may be performed in a different order or in parallel. For example, conductive and non-conductive adhesives may be added in a different order and / or simultaneously (724, 726).

[0118] although Figure 1 WANS device 100, Figure 5 WANS devices 500 and Figure 13A The WANS devices 1300 are each described as devices worn on a single ear of a patient, but other forms of WANS devices can be constructed using the general operating procedures of method 700, such as devices worn on both ears of a patient or devices having flexible body portions and a three-dimensional circuitry system 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 illustrative example including two ear units, the WANS device can be printed in a similar manner, but includes the same or similar elements (e.g., substantially mirrored) for the flexible body portions for each ear. Further with respect to the example, the two flexible body portions can be connected via a band or cord. The band or cord can be molded and / or printed (704) in a manner similar to that described with respect to the flexible body portions. For example, the flexible body portions can be connected by a stretchable "telephone cord" coiled band, a flat stretchable band, a flat semi-rigid band, or other physical connection interconnecting the two flexible body portions. In some embodiments, instead of creating a continuous device with two ear units and connectors (e.g., straps, cables, cords, etc.), two separate ear units can be mounted or inserted into a shared connector. For example, to aid in adjusting the ear units against the ear, each ear unit can be pivotally or rotatably mounted to the connector (e.g., using a ball joint, swivel hinge, etc.). The three-dimensional circuitry layout can be designed (702) to include a main flexible body portion comprising a controller configured to deliver coordinated therapy between the two ear units. In another instance, the WANS device may include two separate ear-hook devices formed in a manner relative to method 700, wherein at least one of the ear-hook devices includes a control circuitry and each ear-hook device includes a wireless communication circuitry for coordinating the delivery of therapeutic pulses.

[0119] Go to Figure 11Example WANS device 1100 includes two ear units 1102a, 1102b connected by a strap 1116, the strap being configured to be worn around the back of the wearer's head (e.g., against the occipital bone). Similar to... Figures 2A to 2E The described example WANS device 100, each ear unit 1102 of the WANS device 1100 includes a front portion 1104, a rear portion 1106, and an ear hook portion 1108. As shown, the left ear unit 1102a includes a control button 1110 and an indicator light 1112. The skin-facing surfaces of the front portions 1104a, 1104b, the rear portions 1106a, 1106b, and the ear hook portions 1108a, 1108b are protected by pads 1114a-f.

[0120] In some embodiments, the control housing 1118 is positioned on the band 1116. In some embodiments, the control housing 1118 includes a control circuitry for delivering therapeutic pulses via electrodes of the ear units 1102a, 1102b. In some embodiments, the control housing 1118 includes a wireless communication unit for receiving control commands from a separate device. For example, a pulse generator assembly of the control housing 1118 may be controlled by commands transmitted wirelessly. The control housing 1118 may further include a power supply circuitry, such as a battery unit, for delivering power to the ear units 1102a, 1102b.

[0121] Go to Figure 12 A block diagram 1200 illustrates an example component of a pulse generator 1250 communicating with an example component of an auricle assembly 1260. In some embodiments, the multi-channel pulse generator circuit 1250 has at least one microcontroller or a microprocessor 1210 having at least one core. For example, when multiple microcontrollers or multiple cores are present, wireless communication 1220 can be controlled, and other cores can be dedicated to controlling therapy. In some embodiments, a low-power programmable logic circuit system (e.g., a field-programmable gate array (FPGA) or a programmable logic device (PLD)) 1212 is also provided. For example, the microcontroller 1210 can be configured to switch to a low-power mode as frequently as possible, while the programmable logic circuit system 1212 controls therapy delivery.

[0122] In some embodiments, inverter circuits 1245a-n are used to generate biphase / bipolar pulses. In some embodiments, one inverter circuit 1245a-n is used for each channel 1270a-n, while in other embodiments, multiple channels 1270a-n use a single inverter circuit 1245. For example, each channel 1245a-n may target a different anatomical region (e.g., tissue region) 1248a-n. High voltage compliance (e.g., >50V, >70V in other embodiments, and >90V in still others) is used to ensure sufficient margin on the potential to generate the current required for strength control 1242a-n of each inverter circuit 1245a-n by providing one or more high voltage inverters 1240a-n to each inverter circuit 1245a-n. In some embodiments, for improved safety, an overcurrent detection circuit 1244a-n is provided in each inverter circuit 1245a-n. In some embodiments, each inverter circuit 1245a-n is provided with an impedance measurement circuit 1246a-n. For example, the impedance measurement circuit 1246a-n may support tracking impedance over time to identify failures in adequate therapy delivery. In some instances, therapy delivery may be affected when the electrode is not in contact with or is not making good contact with the target tissue 1248a-n, when the cable or connector between the multichannel pulse generators 1250 is disconnected from one of the auricle components 1260, or when the electrode has deteriorated or is defective. Monitoring impedance over time provides the additional advantage of tracking the condition of the contact electrodes; thus allowing the controller to alert 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.

[0123] In some implementations, battery 1232 is used to power pulse generator 1250. For example, battery 1232 may power components of pulse generator 1250 and / or auricular assembly 1260 via one or more low-voltage converters 1234. Furthermore, pulse generator 1250 may include high-voltage converter 1236 coupled to one or more high-voltage inverters 1240a-1240n for delivering electrical stimulation therapy via one or more channels 1245a-n.

[0124] In some embodiments, an isolated port 1218, such as a Universal Serial Bus (USB), is used to charge the battery 1232 (e.g., via battery charging circuitry 1230) and communicate with the microcontroller 1210 (e.g., via communication port 1216). Communication can be bidirectional, allowing instructions or entire new codes to be uploaded to the microcontroller 1210 and information stored in memory 1222 to be downloaded. In some embodiments, memory 1222 or other memory can be added to the circuitry as an external component (e.g., for wireless or wired communication with pulse generator 1250). For example, isolated port 1218 (e.g., USB) can be used to connect memory to pulse generator 1250. In other embodiments, at least a portion of memory 1222 may be internal to the microcontroller 1210. In some embodiments, FPGA 1212 may also have internal memory.

[0125] In some embodiments, an external triggering circuit 1224 is included, allowing stimulation to be initiated and / or stopped via an external signal. In some embodiments, the external triggering signal can be transmitted via an isolated port 1218; in yet other embodiments, a modified USB configuration (i.e., not using a standard USB pin configuration) can be used to transmit the triggering signal. Using a modified USB configuration forces the use of a custom USB cable, thus ensuring that external triggering is not provided by incorrectly using an off-the-shelf USB cable. In another instance, the external triggering signal can be wirelessly transmitted from a separate source (e.g., via Bluetooth).

[0126] In some embodiments, a hardware user interface is provided for interacting with a multichannel pulse generator 1250 via a user interface circuitry system 1226. In one example, the user interface circuitry system 1226 may include buttons, LEDs, tactile (e.g., piezoelectric) devices (such as buzzers), and / or displays, or any combination thereof. In some embodiments, the user interface circuitry system 1226 includes signal processing components for interpreting user interface commands delivered via an external device (e.g., via wireless communication 1220). In some instances, the external device may be a smartphone application, a tablet computer, or a medical monitoring device (e.g., in a hospital setting).

[0127] In some embodiments, an external master clock 1228 is used to drive the microcontroller 1210 and / or the FPGA 1212. In other embodiments, the clock of the components may be internal or integrated with or co-packaged with the microcontroller 1210 and / or the FPGA 1212. In some embodiments, one or more oscillators (including, in some cases, an adjustable oscillator 1214) are used to set pulse parameters, such as frequency and / or pulse width.

[0128] In some embodiments, the auricle assembly 1260 is made of a thin, flexible PCB or printed electronics, making it lightweight and easily bendable to adapt to different anatomical structures. In some embodiments, the auricle assembly 1260 has more than one channel. The auricle assembly 1260 or each of its channels may include peak suppression circuitry 1247a-n and electrodes 1265a-n to contact the skin at the location of target tissue 1248a-n. In some embodiments, the auricle assembly 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 circuitry from connecting to the multichannel pulse generator 1250. At least one auricle assembly 1260 is connected to the multichannel pulse generator 1250.

[0129] In one exemplary embodiment, the system utilizes feedback to monitor and / or modify the therapy. Feedback can be obtained from one or more sensors capable of monitoring one or more symptoms being treated with the therapy. For example, after one or more symptoms are relieved or eliminated, the treatment output may similarly decrease or cease. Conversely, when one or more symptoms increase or are added, the treatment output may similarly be activated or adjusted (increased, expanded, etc.). In some instances, the sensors may monitor one or more of the following: electrical skin activity (e.g., sweating), motor activity (e.g., tremor, physiological movement), blood glucose levels, neural 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 adjust the therapy for a given user in a clinical setting. In other embodiments, imaging using, for example, pupillary changes (e.g., pupillary dilation) from a conventional mobile phone and / or smart glasses can be used to provide feedback for therapy adjustments. In some embodiments, one or more sensors are integrated into an earpiece and / or concha device. In some embodiments, one or more sensors are integrated into a pulse generator. For example, periodic monitoring can be achieved by prompting the wearer to touch one or more electrodes on the system (e.g., electrodes built into the surface of the pulse generator) or by otherwise interacting with the pulse generator (e.g., extending the pulse generator away from the body to monitor tremors using motion detectors within the pulse generator). In another embodiment, one or more sensor outputs can be obtained from an external device (such as a fitness computer, smartwatch, or wearable health monitor).

[0130] The monitoring used can be partly based on the treatment setup. For example, EEG monitoring is easier to perform in a hospital setting, while heart rate monitoring can be achieved using a sensor such as a pulse meter built into a stethoscope or another sensor built into a low-budget health monitoring device such as a fitness tracker or smartwatch.

[0131] In illustrative examples, feedback related to electrical skin activity can be used to monitor and detect the speed or timing of symptom and / or treatment outcomes. In one example, electrical skin activity can be sensed by electrodes on a therapeutic earpiece device. In another example, electrical skin activity can be detected by electrodes on another part of the body and transmitted to the system. In some embodiments, the electrical skin electrodes can enable the electrochemical detection of specific substances in the skin (e.g., cortisol).

[0132] 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 to adjust the therapy. In one instance, the one or more motion detectors are configured to detect tremors and / or physiological movements. On the one hand, tremors and / or physiological movements may indicate an underlying condition and / or treatment for the underlying condition. In one instance, tremors and / or physiological movements may indicate symptoms associated with substance withdrawal. On the other hand, feedback from blood glucose monitoring can be used to adjust the therapy.

[0133] In other embodiments, EKG can be used to assess heart rate and heart rate variability to determine general activity of the autonomic nervous system and / or the relative activity of the sympathetic and parasympathetic branches of the autonomic nervous system, and to modulate therapy. Autonomic nervous activity may indicate symptoms associated with substance withdrawal. On one hand, the treatment device can be used to provide therapy for treating heart diseases such as atrial fibrillation and heart failure. In one instance, therapy for modulating the autonomic nervous system can be provided. In some embodiments, the treatment device can be used to provide therapy to balance the ratio between any combination of the autonomic nervous system, parasympathetic nervous system, and sympathetic nervous system.

[0134] On one hand, the system can monitor impedance measurements that allow for closed-loop neural stimulation. In one instance, monitoring feedback can be used to alert the patient / caregiver whether the therapy has been adequately delivered and whether the treatment device has been removed.

[0135] While certain embodiments have been described, these embodiments are presented by way of example only 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 many other forms; furthermore, various omissions, substitutions, and changes can be made to the forms of the methods, apparatuses, and systems described herein without departing from the spirit of this disclosure. The appended claims and their equivalents are intended to cover any forms or modifications that fall within the scope and spirit of this disclosure.

Claims

1. A wearable ear stimulator comprising: A first flexible main body portion, the first flexible main body portion being adapted to be worn at least partially around the wearer's auricle, the first flexible main body portion comprising... Facing the outer side of the skin, and The inner side, opposite to the skin-facing outer side, includes at least one protrusion for supporting the layout of a three-dimensional circuit system, the at least one protrusion protruding away from the skin-facing outer side; A three-dimensional circuit system located on the inner side of the first flexible main body portion, wherein the three-dimensional circuit system includes... Multiple conductive traces are at least partially deposited on the first flexible body portion, such that at least a portion of the multiple conductive traces are configured to extend and / or bend as the first flexible body portion moves. Multiple electrodes configured to deliver electrical stimulation therapy to the wearer via the skin-facing outer side of the first flexible body portion; Multiple electronic components, wherein the multiple electronic components are coupled to the three-dimensional circuit system, Each of the plurality of electronic components is electrically coupled to one or more corresponding traces of the plurality of conductive traces of the three-dimensional circuit system and / or one or more corresponding electrodes of the plurality of electrodes. The plurality of electronic components comprise two or more different types of components selected from the group of component types comprising: lighting components, processing circuit system components, physical control components, communication components, memory components, and combinations thereof, and Each of one or more of the plurality of electronic components is disposed on or above one or more corresponding protrusions of the at least one protrusion. as well as The second flexible body portion is configured to cooperate with the first flexible body portion, thereby substantially encapsulating the three-dimensional circuit system and the plurality of electronic components.

2. The wearable ear stimulator of claim 1, wherein a second or more of the plurality of electronic components are integrated into at least one circuit component, wherein Couple the one or more electronic components to the three-dimensional circuit system by mounting the at least one circuit component to the inside of the first flexible body portion.

3. The wearable ear stimulator of claim 2, wherein the at least one circuit component comprises one or more flexible circuits, one or more rigid flexible circuits, and / or one or more rigid-flexible circuits.

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

5. The wearable ear stimulator of claim 4, wherein the at least one protrusion comprises at least one set of flexible protrusions, each set of flexible protrusions at least partially supporting a corresponding electronic component in a third or more of the plurality of electronic components, wherein Each set of flexible protrusions provides the corresponding electronic component with a limited range of motion relative to the first flexible body portion, and Each set of flexible protrusions is configured to apply friction to resist movement of the corresponding electronic component.

6. The wearable ear stimulator of claim 5, wherein the first group of flexible protrusions in the at least one group of flexible protrusions comprises a plurality of flexible pillars.

7. The wearable ear stimulator of claim 6, wherein the second set of flexible protrusions in the at least one set of flexible protrusions includes a second plurality of flexible posts arranged opposite to the plurality of flexible posts.

8. The wearable ear stimulator according to any one of the preceding claims, wherein the inner side of the first flexible body portion includes at least one hole, wherein Each of the second or more electronic components of the plurality of electronic components is disposed on a corresponding one or more holes in the at least one hole.

9. The wearable ear stimulator according to any one of the preceding claims, wherein the first flexible body portion includes one or more openings through the first flexible body portion, such that at least one surface of each of at least a portion of the plurality of electrodes is exposed to be positioned for electrical skin communication with the wearer near the auricle.

10. The wearable ear stimulator according to any of the preceding claims, wherein at least one of the first flexible body portion or the second flexible body portion includes one or more openings such that, when the first flexible body portion and the second flexible body portion are engaged, at least one of the plurality of electronic components can be accessed via at least one corresponding opening of the one or more openings.

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

12. The wearable ear stimulator according to any one of the preceding claims, wherein the first flexible body portion is formed as a continuous molded part of a single material.

13. The wearable ear stimulator according to any one of the preceding claims, wherein the first flexible body portion comprises: A first segment, configured to be aligned substantially in front of the auricle; and The second section is configured to be aligned substantially against the back of the auricle.

14. The wearable ear stimulator of claim 13, wherein the plurality of conductive traces of the three-dimensional circuitry comprises a first plurality of conductive traces electrically connecting a portion of the plurality of electronic components disposed in the second segment to a portion of the three-dimensional circuitry disposed in the first segment.

15. The wearable ear stimulator of claim 14, wherein the first plurality of conductive traces of the three-dimensional circuitry electrically connect a portion of the plurality of electrodes disposed in the second segment to at least one of a therapeutic stimulation source of the plurality of electronic components disposed in the first segment or a loop electrode of the plurality of electrodes disposed in the first segment.

16. The wearable ear stimulator of claim 14 or claim 15, wherein the first flexible body portion further comprises a third segment configured to be held on at least one of the concha or cavity of the auricle.

17. The wearable ear stimulator of claim 16, wherein at least one of the plurality of electrodes is disposed in the third segment.

18. The wearable ear stimulator according to any one of claims 13 to 17, wherein a first electrode of the plurality of electrodes configured to be positioned on, above or near a branch of the auricular-temporal nerve (ATN) is disposed in the first segment of the first flexible body portion.

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

20. The wearable ear stimulator according to any one of claims 13 to 19, wherein a first electrode of the plurality of electrodes is disposed in a second segment of the first flexible body portion, the first electrode being configured to be positioned on, above or near the auricular branch of the vagus nerve (ABVN), close to the point where the ABVN is exposed through the mastoid canaliculus (MsC).

21. A wearable ear stimulator comprising: A first flexible main body portion, the first flexible main body portion being adapted to be worn at least partially around the wearer's auricle, the first flexible main body portion comprising... Facing the outer side of the skin, and The inner side, opposite to the skin-facing outer side, includes at least one protrusion for supporting the layout of a three-dimensional circuit system, the at least one protrusion protruding away from the skin-facing outer side; A three-dimensional circuit system located on the inner side of the first flexible main body portion, wherein the three-dimensional circuit system includes... Multiple conductive traces are at least partially deposited on the first flexible body portion, such that at least a portion of the multiple conductive traces are configured to extend and / or bend as the first flexible body portion moves. Multiple electrodes configured to deliver electrical stimulation therapy to the wearer via the skin-facing outer side of the first flexible body portion; Multiple electronic components, wherein the multiple electronic components are coupled to the three-dimensional circuit system, Each of the plurality of electronic components is electrically coupled to one or more corresponding traces of the plurality of conductive traces of the three-dimensional circuit system and / or one or more corresponding electrodes of the plurality of electrodes. The plurality of electronic components comprise two or more different types of components selected from the group of component types comprising: lighting components, processing circuit system components, physical control components, communication components, memory components, and combinations thereof, and Each of one or more of the plurality of electronic components is disposed on or above one or more corresponding protrusions of the at least one protrusion. as well as The second flexible body portion is configured to cooperate with the first flexible body portion, thereby substantially encapsulating the three-dimensional circuit system and the plurality of electronic components.

22. The wearable ear stimulator of claim 21, wherein a second or more of the plurality of electronic components are integrated into at least one circuit component. Couplering the one or more electronic components to the three-dimensional circuit system includes mounting the at least one circuit component to the inner side of the first flexible body portion.

23. The wearable ear stimulator of claim 22, wherein the at least one circuit component comprises one or more flexible circuits, and / or one or more rigid flexible circuits, and / or one or more rigid-flexible circuits.

24. The wearable ear stimulator of claim 22 or claim 23, wherein the at least one circuit component comprises one or more three-dimensionally formed circuit components, the one or more three-dimensionally formed circuit components comprising one or more bent or curved portions.

25. The wearable ear stimulator according to claim 24, wherein: The at least one protrusion includes at least one set of flexible protrusions, each set of flexible protrusions at least partially supporting a corresponding electronic component in a third or more of the plurality of electronic components, wherein Each set of flexible protrusions provides the corresponding electronic component with a limited range of motion relative to the first flexible body portion, and Each set of flexible protrusions is configured to apply friction to resist movement of the corresponding electronic component.

26. The wearable ear stimulator of claim 25, wherein the first group of flexible protrusions in the at least one group of flexible protrusions comprises a first plurality of flexible pillars.

27. The wearable ear stimulator of claim 26, wherein the second flexible body portion includes a second plurality of flexible posts arranged opposite to the first plurality of flexible posts.

28. The wearable ear stimulator according to any one of claims 21 to 27, wherein: The inner side of the first flexible body portion includes at least one hole; and Each of the third or more electronic components of the plurality of electronic components is disposed on a corresponding one or more holes in the at least one hole.

29. The wearable ear stimulator of any one of claims 21 to 28, wherein the first flexible body portion includes one or more openings through the first flexible body portion, such that at least one surface of each of at least a portion of the plurality of electrodes is exposed to be positioned for electrical skin communication with the wearer near the auricle.

30. The wearable ear 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 includes one or more openings such that, when the first flexible body portion and the second flexible body portion are engaged, at least one of the plurality of electronic components can be accessed via at least one corresponding opening of the one or more openings, wherein the at least one electronic component includes a control button or a control switch.

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

32. The wearable ear stimulator according to any one of claims 21 to 31, wherein the first flexible body portion comprises: A first segment, configured to be aligned substantially in front of the auricle; and The second section is configured to be aligned substantially against the back of the auricle.

33. The wearable ear stimulator of claim 32, wherein the plurality of conductive traces of the three-dimensional circuitry includes a first plurality of conductive traces electrically connecting a portion of the plurality of electronic components disposed in the second segment to a portion of the three-dimensional circuitry disposed in the first segment.

34. The wearable ear stimulator of claim 33, wherein the first plurality of conductive traces of the three-dimensional circuit system electrically connect a portion of the plurality of electrodes disposed in the second segment to at least one of a therapeutic stimulation source of the plurality of electronic components disposed in the first segment or a loop electrode of the plurality of electrodes disposed in the first segment.

35. The wearable ear stimulator of claim 33 or claim 34, wherein the first flexible body portion further comprises a third segment configured to be held on at least one of the concha or cavity of the auricle, wherein at least one of the plurality of electrodes is disposed in the third segment.

36. A wearable ear stimulator, formed by comprising the following method: A first flexible body portion is formed, the first flexible body portion being configured to at least partially wrap around the auricle of the ear, such that the wearable ear stimulator is substantially supported by the wearer's ear and has a skin-facing outer side and an inner side opposite to the skin-facing outer side, the first flexible body portion comprising at least one of: i) one or more protrusions formed on the inner side and projecting away from the skin-facing outer side; or ii) one or more holes formed in the inner side; A first circuit system with a three-dimensional circuit system layout is deposited on the inner side of the first flexible body portion, the first circuit system comprising... The first plurality of conductive traces are deposited along the inner basal surface. The second plurality of conductive traces extend from the base surface along i) each of at least a portion of the one or more protrusions and / or ii) into each of at least a portion of the one or more holes. Multiple electrodes, and a) one or more conductive landing pads or b) at least one of one or more conductive connection components; One or more electronic components of the three-dimensional circuit system layout are coupled to the first circuit system at a corresponding location of at least one of a) the one or more landing pads or b) the one or more connection components; and The first flexible body portion is covered by a second flexible body portion, thereby encapsulating the three-dimensional circuit system layout within the wearable ear stimulator.

37. The wearable ear stimulator of claim 36, wherein at least one of the one or more electronic components is integrated into at least one circuit component, wherein Coupling the one or more electronic components to the first circuit system includes mounting the at least one circuit component to the first flexible body portion.

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

39. The wearable ear stimulator according to any one of claims 36 to 38, wherein generating the first flexible body portion includes generating one or more openings in the first flexible body portion, each of the one or more openings being disposed at the location of a corresponding electrode among the plurality of electrodes.

40. The wearable ear stimulator of any one of claims 36 to 39, wherein generating the first flexible body portion comprises adding a conductive adhesive to at least one of the one or more holes for adhering a first electronic component of the one or more electronic components to the first flexible body portion.

41. The wearable ear stimulator according to any one of claims 36 to 40, wherein the method further comprises adding a dielectric layer over the three-dimensional circuit system layout.

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

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

44. The wearable ear stimulator according to any one of claims 36 to 43, wherein covering the first flexible body portion comprises overmolding the second flexible body portion onto the first flexible body portion.

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

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

47. The wearable ear stimulator of any one of claims 36 to 46, wherein generating the first flexible body portion comprises forming a set of regions having a material thinner than the remainder of the first flexible body portion, wherein each region in the set of regions is configured to receive a corresponding electrode of the plurality of electrodes.

48. A wearable ear stimulator, formed by comprising the following method: A first flexible body portion is formed, the first flexible body portion being configured to at least partially wrap around the wearer's ear such that the wearable ear stimulator is substantially supported by the wearer's ear and has a skin-facing outer side and an inner side opposite to the skin-facing outer side, the first flexible body portion comprising at least one of: i) one or more protrusions formed on the inner side and projecting away from the skin-facing outer side; or ii) one or more holes formed in the inner side; A first circuit system with a three-dimensional circuit system layout is applied to the inside of the first flexible body portion, the first circuit system comprising... Multiple flexible conductive traces, among which A portion of the plurality of flexible conductive traces i) extends upward along at least a portion of each of the one or more protrusions and / or ii) extends into at least a portion of each of the one or more holes. Multiple electrodes, and a) one or more conductive landing pads or b) at least one of one or more conductive connection components; One or more electronic components of the three-dimensional circuit system layout are coupled to the first circuit system at a corresponding location of at least one of a) the one or more landing pads or b) the one or more connection components; and The first flexible body portion is covered by a second flexible body portion, thereby encapsulating the three-dimensional circuit system layout within the wearable ear stimulator.

49. The wearable ear stimulator of claim 48, wherein the one or more electronic components comprise one or more of an illumination element, a processing circuit system element, a physical control element, a communication element, or a memory element.

50. The wearable ear stimulator of claim 48 or 49, wherein at least one of the one or more electronic components is integrated into at least one circuit component, wherein Coupling the one or more electronic components to the first circuit system includes mounting the at least one circuit component to the first flexible body portion.

51. The wearable ear stimulator of claim 50, wherein the at least one circuit component comprises one or more flexible circuits, one or more rigid flexible circuits, and / or one or more rigid-flexible circuits.

52. The wearable ear stimulator of claim 50, wherein the at least one circuit component comprises one or more three-dimensionally formed circuit components, the one or more three-dimensionally formed circuit components comprising one or more bent or curved portions.

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

54. The wearable ear stimulator according to any one of claims 48 to 53, wherein generating the first flexible body portion includes generating one or more openings in the first flexible body portion, each of at least a portion of the one or more openings being disposed at the location of a corresponding electrode among the plurality of electrodes.

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

56. The wearable ear stimulator of any one of claims 48 to 55, wherein generating the first flexible body portion comprises adding a conductive adhesive to at least one of the one or more holes for adhering a first electronic component of the one or more electronic components to the first flexible body portion.

57. The wearable ear stimulator according to any one of claims 48 to 56, wherein the method further comprises adding a dielectric layer over the three-dimensional circuit system layout.

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

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

60. The wearable ear stimulator according to any one of claims 48 to 59, wherein covering the first flexible body portion comprises overmolding the second flexible body portion onto the first flexible body portion.

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

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

63. The wearable ear stimulator according to any one of claims 48 to 62, wherein generating the first flexible body portion comprises forming a set of regions having a material thinner than the remainder of the first flexible body portion, wherein each region in the set of regions is configured to receive a corresponding electrode of the plurality of electrodes.

64. The wearable ear stimulator according to any one of claims 48 to 63, wherein the first flexible body portion includes a flexible connector portion connecting an auricular mounting section of the first flexible body portion to an ear hook mounting section, the ear hook mounting section being configured to remain against at least one of the concha or cavity of the ear, wherein the ear hook mounting section includes at least one of the plurality of electrodes.

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

66. The wearable ear stimulator of claim 65, wherein each of at least a portion of the one or more openings and / or each region of the one or more regions is positioned at the location of a corresponding electrode among the plurality of electrodes.

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

68. A system for treating one or more neurological disorders using a wearable ear stimulator, the system comprising: The wearable ear stimulator includes... A flexible body adapted to at least partially surround the wearer's ear, the flexible body comprising... Externally, the external surface is positioned to contact the wearer's skin, and Internally, the internal structure is used to support the layout of the three-dimensional circuit system, and The three-dimensional circuit system layout includes... Multiple traces are deposited on the surface of the interior of the flexible body. Multiple electrodes configured to deliver electrical stimulation therapy to the wearer via the skin-facing side of the flexible body, wherein the multiple electrodes comprise The first electrode of the plurality of electrodes is configured to be positioned on, above, or near a branch of the auriculotemporal nerve (ATN), and The second electrode of the plurality of electrodes is configured to be positioned on, above, or near the auricular branch of the vagus nerve (ABVN), and One or more electronic components, each electronic component being electrically coupled to a portion of the plurality of electrodes and / or the plurality of traces, the one or more electronic components including processing circuitry system elements for delivering at least one electrical stimulation therapy via the plurality of electrodes; as well as A controller configured to instruct the processing circuitry system elements of the one or more electronic components to deliver at least one electrical stimulation therapy via the plurality of electrodes to treat the one or more neurological conditions, wherein the at least one electrical stimulation therapy comprises Stimulating the ATN via the first electrode, and The ABVN is stimulated via the second electrode; The flexible body of the wearable ear stimulator includes multiple openings and / or multiple thinned material regions for enabling electrical communication between each of the multiple electrodes and the wearer's skin near the auricle.

69. The system according to claim 68, wherein: The interior of the flexible body includes at least one protrusion; and Each of the at least one electronic component is disposed on or above one or more of the at least one protrusion.

70. The system of claim 68 or claim 69, wherein the one or more neurological disorders comprise 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 ear stimulator includes the controller.

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

73. A system for inducing neuronal plasticity or neuroplasticity using a wearable ear stimulator to stimulate cognitive improvement and / or reduce cognitive decline in a wearer, the system comprising: The wearable ear stimulator includes... A flexible body adapted to at least partially surround the wearer's ear, the flexible body comprising... Externally, the external surface is positioned to contact the wearer's skin, and Internally, the internal structure is used to support the layout of the three-dimensional circuit system, and The three-dimensional circuit system layout includes... Multiple traces are deposited on the surface of the interior of the flexible body. Multiple electrodes configured to deliver electrical stimulation therapy to the wearer via the skin-facing side of the flexible body, wherein the multiple electrodes comprise The first electrode of the plurality of electrodes is configured to be positioned on, above, or near a branch of the auriculotemporal nerve (ATN), and The second electrode of the plurality of electrodes is configured to be positioned on, above, or near the auricular branch of the vagus nerve (ABVN), and One or more electronic components, each electronic component being electrically coupled to a portion of the plurality of electrodes and / or the plurality of traces, the one or more electronic components including processing circuitry system elements for delivering at least one electrical stimulation therapy via the plurality of electrodes; as well as A controller configured to instruct the processing circuitry system elements of the one or more electronic components to deliver at least one electrical stimulation therapy via the plurality of electrodes to induce neuronal plasticity or neuroplasticity in the wearer, wherein the at least one electrical stimulation therapy comprises Stimulating the ATN via the first electrode, and The ABVN is stimulated via the second electrode; The flexible body of the wearable ear stimulator includes multiple openings and / or multiple thinned material regions for enabling electrical communication between each of the multiple electrodes and the wearer's skin near the auricle.

74. The system according to claim 73, wherein: The interior of the flexible body includes at least one protrusion; and Each of the at least one electronic component is disposed on or above one or more of the at least one protrusion.

75. The system of claim 73 or claim 74, wherein inducing neuronal plasticity or neuroplasticity in the wearer comprises one or more of improving learning, accelerating stroke recovery, improving memory, or increasing alertness.

76. The system of claim 75, wherein improving memory comprises alleviating symptoms of dementia and / or Alzheimer's disease and / or slowing its progression.

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

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

79. A system for relieving pain in a wearer using a wearable ear stimulator, the system comprising: The wearable ear stimulator includes... A flexible body adapted to at least partially surround the wearer's ear, the flexible body comprising... Externally, the external surface is positioned to contact the wearer's skin, and Internally, the internal structure is used to support the layout of the three-dimensional circuit system, and The three-dimensional circuit system layout includes... Multiple traces are deposited on the surface of the interior of the flexible body. Multiple electrodes configured to deliver electrical stimulation therapy to the wearer via the skin-facing side of the flexible body, wherein the multiple electrodes comprise The first electrode of the plurality of electrodes is configured to be positioned on, above, or near a branch of the auriculotemporal nerve (ATN), and The second electrode of the plurality of electrodes is configured to be positioned on, above, or near the auricular branch of the vagus nerve (ABVN), and One or more electronic components, each electronic component being electrically coupled to a portion of the plurality of electrodes and / or the plurality of traces, the one or more electronic components including processing circuitry system elements for delivering at least one electrical stimulation therapy via the plurality of electrodes; as well as A controller configured to instruct the processing circuitry system elements of the one or more electronic components to deliver at least one electrical stimulation therapy via the plurality of electrodes to alleviate the wearer's pain, wherein the at least one electrical stimulation therapy comprises Stimulating the ATN via the first electrode, and The ABVN is stimulated via the second electrode; The flexible body of the wearable ear stimulator includes multiple openings and / or multiple thinned material regions for enabling electrical communication between each of the multiple electrodes and the wearer's skin near the auricle.

80. The system according to claim 79, wherein: The interior of the flexible body includes at least one protrusion; and Each of the at least one electronic component is disposed on or above one or more of the at least one protrusion.

81. The system of claim 79 or claim 80, wherein the at least one electrical stimulation therapy is configured to treat one or more of substance withdrawal symptoms, migraine, cluster headache, acute pain, chronic pain, menstrual pain, menstrual cramps, or temporomandibular joint disorder (TMD).

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

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

84. A system for increasing the clotting rate and / or reducing bleeding in a wearable ear stimulator, the system comprising: The wearable ear stimulator includes... A flexible body adapted to at least partially surround the wearer's ear, the flexible body comprising... Externally, the external surface is positioned to contact the wearer's skin, and Internally, the internal structure is used to support the layout of the three-dimensional circuit system, and The three-dimensional circuit system layout includes... Multiple traces are deposited on the surface of the interior of the flexible body. Multiple electrodes configured to deliver electrical stimulation therapy to the wearer via the skin-facing side of the flexible body, wherein the multiple electrodes comprise The first electrode of the plurality of electrodes is configured to be positioned on, above, or near a branch of the auriculotemporal nerve (ATN), and The second electrode of the plurality of electrodes is configured to be positioned on, above, or near the auricular branch of the vagus nerve (ABVN), and One or more electronic components, each electronic component being electrically coupled to a portion of the plurality of electrodes and / or the plurality of traces, the one or more electronic components including processing circuitry system elements for delivering at least one electrical stimulation therapy via the plurality of electrodes; as well as A controller configured to instruct the processing circuitry system elements of the one or more electronic components to deliver at least one electrical stimulation therapy via the plurality of electrodes to increase the wearer's clotting rate and / or reduce bleeding, wherein the at least one electrical stimulation therapy comprises Stimulating the ATN via the first electrode, and The ABVN is stimulated via the second electrode; The flexible body of the wearable ear stimulator includes multiple openings and / or multiple thinned material regions for enabling electrical communication between each of the multiple electrodes and the wearer's skin near the auricle.

85. The system according to claim 84, wherein: The interior of the flexible body includes at least one protrusion; and Each of the at least one electronic component is disposed on or above one or more of the at least one protrusion.

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

87. The system of claim 86, wherein the at least one electrical stimulation therapy is configured to be delivered to the wearer prior to surgery.

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 suffering from a coagulation disorder.

89. The system of claim 88, wherein the coagulation disorder is one of hemophilia, hemophilia A, hemophilia B, hemophilia C, von Wöhlerbrand 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 therapy is configured to treat menorrhagia and / or excessive menstrual bleeding.

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

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

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

94. A system for increasing the clotting rate and / or reducing bleeding in a wearable ear stimulator, the system comprising: The wearable ear stimulator includes... A flexible body adapted to at least partially surround the wearer's ear, the flexible body comprising... Externally, the external surface is positioned to contact the wearer's skin, and Internally, the internal structure is used to support the layout of the three-dimensional circuit system, and The three-dimensional circuit system layout includes... Multiple electrodes configured to deliver electrical stimulation therapy to the wearer via the skin-facing side of the flexible body, wherein the multiple electrodes comprise The first electrode of the plurality of electrodes is configured to be positioned on, above, or near a branch of the auriculotemporal nerve (ATN), and / or The second electrode of the plurality of electrodes is configured to be positioned on, above, or near the auricular branch of the vagus nerve (ABVN), and One or more electronic components, each of the one or more electronic components being electrically coupled to i) a portion of the plurality of electrodes and / or ii) one or more flexible conductive traces deposited on the surface of the interior of the flexible body, the one or more electronic components comprising processing circuitry system elements for delivering at least one electrical stimulation therapy via the plurality of electrodes; as well as A controller configured to instruct the processing circuitry system elements of the one or more electronic components to deliver at least one electrical stimulation therapy via the plurality of electrodes to increase the wearer's clotting rate and / or reduce bleeding, wherein the at least one electrical stimulation therapy comprises Stimulating the ATN via the first electrode, and / or The ABVN is stimulated via the second electrode; The flexible body of the wearable ear stimulator includes multiple openings and / or multiple thinned areas of material for enabling electrical communication between each of the multiple electrodes and the wearer's skin.

95. The system according to claim 94, wherein: The interior of the flexible body includes at least one protrusion; and Each of the at least one electronic component is disposed on or above one or more of the at least one protrusion.

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

97. The system of claim 96, wherein the at least one electrical stimulation therapy is configured to be delivered to the wearer prior to surgery.

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 suffering from a coagulation disorder.

99. The system of claim 98, wherein the coagulation disorder is one of hemophilia, hemophilia A, hemophilia B, hemophilia C, von Wöhlerbrand 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 therapy is configured to treat menorrhagia and / or excessive menstrual bleeding.

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

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

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

104. The system according to any one of claims 94 to 103, wherein the one or more electronic components further comprise one or more of a lighting 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 includes one or more holes formed on the inside; wherein a portion of the plurality of flexible conductive traces extends into at least a portion of each of the one or more holes.

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

107. The system of claim 106, wherein the at least one circuit component comprises one or more flexible circuits, one or more rigid flexible circuits, and / or one or more rigid-flexible circuits.

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

109. The system according to any one of claims 94 to 108, wherein the flexible body comprises: A first segment, configured to be aligned substantially in front of the auricle; and The second section is configured to be aligned substantially against the back of the auricle.

110. The system according to any one of claims 94 to 109, wherein the flexible body comprises: An auricular mounting portion, said auricular mounting portion being worn at least partially around the auricle of the wearer; The ear-hook mounting portion is configured to remain against at least one of the concha or cavity of the ear; as well as A flexible connector that connects the auricle mounting portion to the ear hook mounting portion; The ear-mounting portion therein includes at least one of the plurality of electrodes.

111. The system according to any one of claims 94 to 110, wherein the flexible body of the wearable ear stimulator includes at least one opening and / or at least one thinned material region of the flexible body for enabling a wearer to operate control elements of the one or more electronic components.

112. The system according to any one of claims 94 to 111, wherein the flexible body comprises: The first flexible main body portion includes... The outer side facing the skin is adapted to contact the skin around the wearer's auricle, and The inner side, which is opposite to the outer side facing the skin; and The second flexible body portion is configured to cooperate with the first flexible body portion, thereby substantially encapsulating the three-dimensional circuit system and the plurality of electronic components as well as the second flexible body portion.

113. The system of claim 112, wherein the second flexible body portion includes one or more openings and / or one or more thinned material regions of the second flexible body portion for enabling electrical communication between each of one or more of the plurality of electrodes and the wearer's skin.

114. A system for reducing inflammation in a wearable ear stimulator, the system comprising: The wearable ear stimulator includes... A flexible body adapted to at least partially surround the wearer's ear, the flexible body comprising... Externally, the external surface is positioned to contact the wearer's skin, and Internally, the internal structure is used to support the layout of the three-dimensional circuit system, and The three-dimensional circuit system layout includes... Multiple traces are deposited on the surface of the interior of the flexible body. Multiple electrodes configured to deliver electrical stimulation therapy to the wearer via the skin-facing side of the flexible body, wherein the multiple electrodes comprise The first electrode of the plurality of electrodes is configured to be positioned on, above, or near a branch of the auriculotemporal nerve (ATN), and The second electrode of the plurality of electrodes is configured to be positioned on, above, or near the auricular branch of the vagus nerve (ABVN), and One or more electronic components, each electronic component being electrically coupled to a portion of the plurality of electrodes and / or the plurality of traces, the one or more electronic components including processing circuitry system elements for delivering at least one electrical stimulation therapy via the plurality of electrodes; as well as A controller configured to instruct the processing circuitry system elements of the one or more electronic components to deliver at least one electrical stimulation therapy via the plurality of electrodes to reduce inflammation in the wearer, wherein the at least one electrical stimulation therapy comprises Stimulating the ATN via the first electrode, and The ABVN is stimulated via the second electrode; The flexible body of the wearable ear stimulator includes multiple openings and / or multiple thinned material regions for enabling electrical communication between each of the multiple electrodes and the wearer's skin near the auricle.

115. The system according to claim 114, wherein: The interior of the flexible body includes at least one protrusion; and Each of the at least one electronic component is disposed on or above one or more of the at least one protrusion.

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

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

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

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

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

121. A wearable ear stimulator, formed by comprising the following method: A first flexible body portion is formed, the first flexible body portion being configured to at least partially wrap around the wearer's ear such that the wearable ear stimulator is substantially supported by the wearer's ear and has a skin-facing outer side and an inner side opposite to the skin-facing outer side, the first flexible body portion comprising at least one of: i) one or more protrusions formed on the inner side and projecting away from the skin-facing outer side; or ii) one or more holes formed in the inner side; A first circuit system with a three-dimensional circuit system layout is applied to the inside of the first flexible body portion, the first circuit system comprising... Multiple flexible conductive traces, among which A portion of the plurality of flexible conductive traces i) extends upward along at least a portion of each of the one or more protrusions and / or ii) extends into at least a portion of each of the one or more holes. Multiple electrodes, and a) one or more conductive landing pads or b) at least one of one or more conductive connection components; One or more electronic components of the three-dimensional circuit system layout are coupled to the first circuit system at a corresponding location of at least one of a) the one or more landing pads or b) the one or more connection components; and The first flexible body portion is covered by a second flexible body portion, thereby encapsulating the three-dimensional circuit system layout within the wearable ear stimulator.

122. The wearable ear stimulator of claim 121, wherein the one or more electronic components comprise one or more of an illumination element, a processing circuit system element, a physical control element, a communication element, or a memory element.

123. The wearable ear stimulator of claim 121 or claim 122, wherein at least one of the one or more electronic components is integrated into at least one circuit component, wherein Coupling the one or more electronic components to the first circuit system includes mounting the at least one circuit component to the first flexible body portion.

124. The wearable ear stimulator of claim 123, wherein the at least one circuit component comprises one or more flexible circuits, one or more rigid flexible circuits, and / or one or more rigid-flexible circuits.

125. The wearable ear stimulator of claim 123 or claim 124, wherein the at least one circuit component comprises one or more three-dimensionally formed circuit components, the one or more three-dimensionally formed circuit components comprising one or more bent or curved portions.

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

127. The wearable ear stimulator according to any one of claims 121 to 126, wherein generating the first flexible body portion includes generating one or more openings in the first flexible body portion, each of at least a portion of the one or more openings being disposed at the location of a corresponding electrode among the plurality of electrodes.

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

129. The wearable ear stimulator of any one of claims 121 to 128, wherein generating the first flexible body portion comprises adding a conductive adhesive to at least one of the one or more holes for adhering a first electronic component of the one or more electronic components to the first flexible body portion.

130. The wearable ear stimulator according to any one of claims 121 to 129, wherein the method further comprises adding a dielectric layer over the three-dimensional circuit system layout.

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

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

133. The wearable ear stimulator according to any one of claims 121 to 132, wherein covering the first flexible body portion comprises overmolding the second flexible body portion onto the first flexible body portion.

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

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

136. The wearable ear stimulator of claim 135, wherein generating the first flexible body portion comprises forming a set of regions having a material thinner than the remainder of the first flexible body portion, wherein each region in the set of regions is configured to receive a corresponding electrode of the plurality of electrodes.

137. The wearable ear stimulator according to any one of claims 121 to 136, wherein the first flexible body portion includes a flexible connector portion connecting an auricular mounting section of the first flexible body portion to an ear hook mounting section, the ear hook mounting section being configured to remain against at least one of the concha or cavity of the ear, wherein the ear hook mounting section includes at least one of the plurality of electrodes.

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

139. The wearable ear stimulator of claim 138, wherein each of at least a portion of the one or more openings and / or each region of the one or more regions is positioned at the location of a corresponding electrode among the plurality of electrodes.

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

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