Wearable devices with adjustment mechanisms

Abstract

An example device for placement relative to an ear includes a housing; a first extending structure; a second extending structure, the first and second extending structures are separated by an adjustable distance; a carriage coupled to the second extending structure and being at least partially disposed within the housing, the carriage being configured to move longitudinally along the housing and an adjustment mechanism configured to impart a force to cause longitudinal movement of the carriage to adjust the adjustable distance.

Description

[0001] WEARABLE DEVICES WITH ADJUSTMENT MECHANISMS

[0002] CROSS REFERENCE TO RELATED APPLICATIONS

[0003] The present application claims the benefit of and priority to US Prov. Pat. App. No. 63 / 744,537, filed January 13, 2025, titled WEARABLE DEVICES WITH ADJUSTMENT MECHANISMS, US Prov. Pat. App. No. 63 / 698,299, filed September 24, 2024, titled ANTI-INFLAMMATORY AURICULAR VAGAL NERVE STIMULATION, and US Prov. Pat. App. No. 63 / 656,895, filed June 6, 2024, titled ANTI-INFLAMMATORY AURICULAR VAGAL NERVE STIMULATION, the disclosures of which are incorporated herein by reference.

[0004] BACKGROUND

[0005] Wearable devices, particularly those designed to be disposed in or around the ear, have gained significant popularity in recent years. These devices, such as earbuds, are small, portable, and often wireless, providing users with hands-free access to audio, communication, and various small functions. Earbuds can connect to smartphones, computers, and other devices via Bluetooth, offering features like noise cancellation, voice assistants, fitness tracking, and even health monitoring and / or treatment of various health related issues. Their compact size and comfort make them ideal for daily use, whether for listening to music, taking calls, or tracking physical activity

[0006] The vagus nerve is linked to several neural systems of the body that can affect a wide variety of conditions. Commercial systems are available using an implanted pulse generator and a lead extending to the left vagus nerve, and are used to treat epilepsy or depression, and to aid post-stroke rehabilitation as the patient relearns aspects of physical movement. New and alternative ways of stimulating the vagus nerve are also being researched and written about. Some research suggests that the auricular branch of the vagus nerve may be usefully stimulated to address a range of conditions including stress, inflammation, mental focus, etc. New and alternative devices and methods for stimulating the vagus nerve near the ear are desired.

[0007] OVERVIEW A first illustrative and non-limiting example takes the form of a wearable device adapted for placement relative to an car of a patient, comprising a housing containing, electronics and a power source; wherein the housing comprises a lower container and an upper lid, a first extending structure having a first end at the housing and a second end apart from the housing, the first extending structure having a first length, the second end configured for contacting the posterior edge of the crus and / or antitragus; a first anchor arm extending laterally from the first extending structure and carrying an anchor element thereon, the anchor element configured for positioning beneath a tragus of the ear of the patient to thereby support positioning of the device; a second extending structure comprising a first end at the housing and a second end apart from the housing, wherein the first and second extending structures are separated by an adjustable distance; a carriage coupled to the first end of the second extending structure and being at least partially disposed within the housing, wherein the carriage is configured to move longitudinally along a length of the housing; and an adjustment mechanism coupled to the carriage, wherein the adjustment mechanism is configured to impart a force to cause longitudinal movement of the carriage to adjust the adjustable distance.

[0008] Additionally or alternatively, the adjustment mechanism is configured to press the first extending structure to apply force to opposed sides of the rim of the concha, to thereby hold the wearable device in a desired position in the ear of the patient. Additionally or alternatively, the opposed sides comprise one of an inferior crus or antihelix of the patient, and any one of the tragus, anti-tragus, or posterior edge of the antihelix.

[0009] Additionally, or alternatively, wherein the adjustment mechanism is an individual adjustment mechanism. Additionally, or alternatively, wherein: the adjustment mechanism is located at a first end of the housing; and a portion of the adjustment mechanisms extends a distance from the first end of the housing and a portion of the adjustment mechanism is located inside of the housing.

[0010] Additionally, or alternatively, wherein the adjustment mechanism is configured to be actuated by contact from one or more digits on an individual hand of a person to impart a force to cause longitudinal movement of the carriage and adjust the adjustable distance.

[0011] Additionally, or alternatively, wherein the adjustment mechanism is integral with the carriage. Additionally, or alternatively, wherein the adjustment mechanism is located on a first end of the carriage. Additionally, or alternatively, wherein adjustment mechanism comprises a protrusion extending radially from the carriage. Additionally, or alternatively, wherein the adjustment mechanism comprises a separate component that is coupled to the carriage. Additionally, or alternatively, wherein adjustment mechanism comprises a lever or a wheel. Additionally, or alternatively, wherein the adjustment mechanism further comprises a rotatable adjustment mechanism including an annulus, wherein the rotatable adjustment mechanism is configured to rotate about the annulus relative to the carriage, the housing, or both the carriage and the housing.

[0012] Additionally, or alternatively, wherein: the housing includes a slot extending through the first end of the housing; the rotatable adjustment mechanism comprises: a lever extending laterally therefrom through the slot to a position outside of the housing; and teeth disposed along at least a portion of a periphery of the rotatable adjustment mechanism that is located in the housing; and the carriage includes corresponding teeth that are configured to interface with the teeth to impart a force on the carriage to cause the longitudinal movement of the carriage responsive to rotation of the lever of the adjustment mechanism.

[0013] Additionally, or alternatively, wherein the carriage includes an elongated longitudinal slot extending along a portion of the length of the carriage; and the lower lid includes a peg configured to extend into the elongated longitudinal slot. Additionally, or alternatively, wherein the housing includes a slot extending through the first end of the housing; and the rotatable adjustment mechanism comprises a wheel with a toothed surface along at least a portion of a periphery of the rotatable adjustment mechanism and a curvilinear slot extending within a portion of the wheel.

[0014] Another illustrative and non- limiting example takes the form of a wearable device adapted for placement relative to an ear of a patient, comprising: a housing containing, electronics and a power source, the housing comprises a lower container and an upper lid defining a cavity therebetween; a first extending structure having a first end at the housing and a second end apart from the housing, the first extending structure having a first length, the second end configured for contacting the posterior edge of the crus and / or antitragus; a first anchor arm extending laterally from the first extending structure and carrying an anchor element thereon, the anchor element configured for positioning beneath a tragus of the ear of the patient to thereby support positioning of the device; a second extending structure comprising a first end at the housing and a second end apart from the housing, wherein the first and second extending structures arc separated by an adjustable distance; a carriage coupled to the first end of the second extending structure and being at least partially disposed within the cavity of the housing, wherein the carriage is configured to translate longitudinally along a length of the housing; and an adjustment mechanism coupled to the carriage, wherein the adjustment mechanism is an individual adjustment mechanism that is configured to impart a force to cause longitudinal translation of the carriage to adjust the adjustable distance.

[0015] Additionally, or alternatively, wherein the adjustment mechanism comprises a fixed protrusion extending radially from the carriage or a rotatable adjustment mechanism coupled to an end of the carriage.

[0016] Additionally, or alternatively, wherein the first extending structure is located on a first side of the housing, a second side of the housing opposite the first side comprises at least one control button or switch for controlling activity of the electronics including a multi-purpose light-emitting diode configured in a ring including a plurality of respective progress segments to indicate a device status and stimulation progress during a therapeutic stimulation session.

[0017] Another illustrative and non- limiting example takes the form of a method of placing a wearable device, the device comprising a housing and a first extending structure carrying thereon an anchor arm adapted for positioning in the auditory canal of a user, a second extending structure spaced from the first extending structure, a carriage coupled to the second extending structure, and an adjustment mechanism disposed at a first end of the housing and being configured to adjust a distance between the second extending structure and the first extending structure by imparting a force on the carriage to cause longitudinal movement of the carriage, the method comprising: placing the anchor arm in the auditory canal or at least partially beneath the tragus; and actuating the adjustment mechanisms to vary and adjustable distance between the first extending structure and the second extending structure until the second extending structure abuts the helix, the antihelix, the inferior crus, or any combination thereof. Additionally, or alternatively, wherein actuating the adjustment mechanism further comprises actuating the adjustment mechanism subsequent to placing the anchor arm in the auditory canal or at least partially beneath the tragus.

[0018] Additionally, or alternatively, wherein the adjustment mechanism is spring loaded to expand, and actuating the adjustment mechanism further comprises compression against the expansion such that when released the spring expands to securely anchor the device between the antihelix and lower concha.

[0019] Additionally, or alternatively, further comprising actuating the adjustment mechanism with one or more digits on an individual hand of a user.

[0020] Additionally, or alternatively, wherein the carriage, the adjustment mechanism, the housing, or any combination thereof, includes detents.

[0021] Additionally, or alternatively, wherein the carriage, the housing, or both the carriage and the housing includes detents to resist or arrest movement of the carriage into one or more spaced intervals, wherein detents are one of magnetic or mechanical structures.

[0022] Additionally, or alternatively, wherein the adjustment mechanism includes detents to resist or arrest movement of the carriage into one or more spaced intervals, wherein detents are one of magnetic or mechanical structures

[0023] Additionally, or alternatively, wherein the first vagus nerve stimulation element is positioned on the first extending structure or the second extending structure.

[0024] Additionally, or alternatively, wherein the first vagus nerve stimulation element is positioned on the first extending structure.

[0025] Additionally, or alternatively, wherein the first vagus nerve stimulation element is positioned on the second extending structure.

[0026] Additionally, or alternatively, wherein the first vagus nerve stimulation element is one of an optical transducer, a thermal transducer, a magnetic transducer, or a mechanical transducer; the vagus nerve stimulation device further includes a second vagus nerve stimulation element; both the first and the second vagus nerve stimulation elements are electrodes; the operational circuitry includes output circuitry configured to issue electrical signals via the electrodes; and the method further comprises performing electrical stimulation via the electrodes in accordance with the electrical signals issued from the output circuitry subsequent to actuating the adjustment mechanisms to vary the adjustable distance between the first extending structure and the second extending structure.

[0027] Additionally, or alternatively, a speaker, an electrical sensor, or both a speaker and an electrical sensor is positioned on the first extending structure or the second extending structure, and wherein the device has an absence of a nerve stimulating element.

[0028] This overview is intended to introduce the subject matter of the present patent application. It is not intended to provide an exclusive or exhaustive explanation. The detailed description is included to provide further information about the present patent application.

[0029] BRIEF DESCRIPTION OF THE DRAWINGS

[0030] The drawings illustrate, by way of example, but not by way of limitation, various embodiments discussed herein. In the drawings, which are not necessarily drawn to scale, like numerals may describe similar components in different views.

[0031] Figure 1A is a sketch of the human ear;

[0032] Figure IB shows several angles that may be used to provide opposing forces to hold a device in the ear;

[0033] Figures 2A-2C are views of a first wearable vagus nerve modulation device;

[0034] Figures 3A-3C are views of a second wearable vagus nerve modulation device;

[0035] Figures 4A-4C are views of a third wearable vagus nerve modulation device;

[0036] Figures 5A-5C are views of a fourth wearable vagus nerve modulation device;

[0037] Figure 6 illustrates placement of a wearable vagus nerve modulation device;

[0038] Figures 7 is a side section view illustrating electrode contact to the ear;

[0039] Figures 8A-8B shows an illustrative example of status and warning lights;

[0040] Figures 9A-9B shows an illustrative example of status and warning lights;

[0041] Figures 10A-10G show illustrative stimulation device designs;

[0042] Figure 11 is a block diagram for illustrative circuitry;

[0043] Figures 12A-12B show a block process flow diagram of an illustrative method;

[0044] Figures 13-14 illustrate wearable devices and charging systems;

[0045] Figure 15 illustrates various electrode combinations that may be used; Figures 16-18 illustrate further alternative designs for wearable vagus nerve modulation devices; and

[0046] Figures 19-20 show illustrative gel pad designs.

[0047] DETAILED DESCRIPTION

[0048] Figure 1 A is a sketch of the human ear. The auditory canal is covered at its opening by the tragus, and opens adjacent the concha. The concha is typically bisected by the crus helix into the conchae cymba superiorly and conchae cavum inferiorly. The helix is the outer rim of the ear that extends from the superior insertion of the ear on the scalp to the termination of the cartilage at the earlobe, having a superior aspect and posterior aspect, as marked in the drawing. The border of the helix usually forms a rolled rim, but the helix is highly variable in shape. The crus helix is the continuation of the anteroinferior ascending portion of the helix, and as shown in the drawing, extends in a posteroinferior direction into the cavity of the concha, typically about one half to two thirds the distance across the concha. The concha is generally bordered by the antihelix superiorly and antitragus inferiorly.

[0049] The auditory branch of the vagus nerve terminates in the crus helix. Because the vagus nerve can respond to stimuli (electrical, vibratory, acoustic, thermal, magnetic, optical, etc.) in desirable ways, any access point where such stimuli can be delivered is of great interest. Solutions for reliable, and preferably non-invasive access are in demand. Embodiments disclosed herein address shortcomings of prior approaches, as further described below.

[0050] A used herein, the phrase “nerve modulation” refers to the use of a signal, such as an electrical pulse, pulse train or other electrical signal, or any of a vibratory, acoustic, thermal, magnetic, or optical signals, to affect the nerve itself, processes the nerve controls or influences, and / or structures to which the nerve leads. More than one modality may be combined together, such as using optical and electrical stimulation together. Combinations may include alternating between two modalities, or using two modalities directed at a single volume of tissue, or directing one modality at one volume of tissue or target, while (or interleaved with) directing another modality at a different volume of tissue. Modulation may include up-regulating, down-regulating, blocking, etc. Modulation may include causing action potentials, blocking action potentials, or affecting the nerve by sub-action- potcntial processes. Modulation is thus used as a catch-all, and a specific mechanism of action is not to be inferred from this usage. Some examples below describe particular waveforms and / or effects which can fall into the broad category of modulation. The words “modulation” and “stimulation” may be used interchangeably herein.

[0051] In the context of a patient who has suffered from a trauma, such as a subarachnoid hemorrhage from stroke, aneurysm, or other vascular event affecting the brain, subsequent inflammatory response can be harmful. The inflammatory response may occur hours or days after the causative event. Additional discussion and details of underlying causes and effects of the post- stroke inflammatory response are in World Intellectual Property Organization Pub. No. W02023059760, published April 13, 2023, titled SYSTEMS AND METHODS FOR REDUCING INFLAMMATION IN THE CENTRAL NERVOUS SYSTEM, the disclosure of which is incorporated herein by reference.

[0052] There are numerous other injuries to the brain that can be associated with, cause, or lead to inflammation, and in many cases controlling or modulating that inflammation may aid in the healing process and / or prevent further injury. Concussions, for example, are (often mild) traumatic brain injuries caused by a blow to the head or sudden acceleration or deceleration of the head. Brain contusion, including cerebral contusion, is generally more severe than concussion, and involves actual bruising of the brain tissue. Cerebral or other intracranial hemorrhage involves bleeding in the brain, which can be caused by trauma or conditions such as aneurysms or strokes. Diffuse axonal injury involves damage to the brain's white matter caused by rapid acceleration or deceleration, leading to widespread axonal damage. Traumatic brain injury (TBI) relates to a broad category of brain injuries caused by external forces, ranging from mild concussions to severe injuries with long-term consequences. Penetrating head injury involves damage to the brain caused by a foreign object penetrating the skull, such as a bullet or a sharp object. Cerebral edema involves swelling of the brain tissue due to various causes, including trauma, infection, or stroke. Hypoxic-ischemic brain injury involves damage to the brain cells due to lack of oxygen or blood flow, leading to cell death and potential long-term deficits. Skull fracture, which involves a break in one or more of the bones of the skull can lead to brain injury, including, for example, if the fracture extends into the brain tissue. These various injuries may overlap and are neither exclusive nor exhaustive of the injuries that can affect the brain and lead to inflammatory response that may cause further damage and / or impair or delay the healing process. Treatment to reduce or modulate such inflammation may be desired.

[0053] In addition to injuries as the cause of inflammatory response, various disease conditions and / or infections can be associated with inflammation. For example, encephalitis is an inflammation of the brain usually caused by viral infections such as herpes simplex virus, West Nile virus, or autoimmune reactions. Meningitis is an inflammation of the protective membranes covering the brain and spinal cord, which can be caused by bacterial, viral, or fungal infections. Multiple Sclerosis (MS) is an autoimmune condition where the immune system attacks the protective covering of nerves in the brain and spinal cord, leading to inflammation and damage. A brain abscess is a collection of pus within the brain tissue, often caused by bacterial infections that lead to inflammation. Inflammation can occur around brain tumors as the body's immune response tries to contain or eliminate the abnormal growth. Autoimmune encephalitis includes inflammatory conditions caused by the immune system attacking healthy brain tissue, leading to symptoms such as seizures, cognitive impairment, and psychiatric symptoms. Neurodegenerative diseases and conditions, such as Alzheimer's disease, Parkinson's disease, and amyotrophic lateral sclerosis (ALS), can involve chronic inflammation in the brain, contributing to disease progression and symptoms. HIV-associated neurocognitive disorders (HAND) can also cause inflammation in the brain as a result of HIV infection, leading to cognitive impairment and other neurological symptoms. Treatment to reduce or modulate such inflammation may be desired.

[0054] Inflammation in the brain may also occur as a result of clinical conditions associated with bodily inflammation. Some illustrative conditions include, for example and without limitation, rheumatoid arthritis, osteoarthritis, inflammatory bowel disease (Crohn's disease, ulcerative colitis), psoriasis, asthma, chronic obstructive pulmonary disease (COPD), chronic sinusitis, chronic kidney disease, periodontal disease, diabetes, atherosclerosis, hepatitis, pancreatitis, endometriosis, and / or gout. Treatment to reduce or modulate such inflammation may be desired.

[0055] For patients suffering from any of these injuries, diseases, infections or conditions, the ability to control or modulate the inflammatory response may be helpful to recovery or healing or alleviation of other symptoms. Likewise, reducing, modulating or otherwise changing the degree of inflammation the patient experiences may prevent further injury in some circumstances.

[0056] Inflammation can also play a key role as patients are recovering from central or systemic insults in the intensive care unit (ICU). Inflammation can be associated with a variety of diagnoses, including for example and without limitation, sepsis, acute respiratory distress syndrome (ARDS), pneumonia, pancreatitis, peritonitis, meningitis, acute kidney injury, acute liver failure, acute myocardial infarction and congestive heart failure, traumatic brain injury, burns, surgical complications, systemic inflammatory response syndrome (SIRS), multi-organ dysfunction syndrome (MODS), and / or post-operative infections These conditions can lead to systemic inflammation, which can further exacerbate organ dysfunction and contribute to poor outcomes in critically ill patients. Close monitoring and prompt treatment of inflammation are crucial in managing patients in the ICU.

[0057] The aim in some examples herein is to provide a wearable device which is compact and non-intrusive, being easily placed and operated for a patient during an in-hospital stay for example in the intensive care unit. Some examples may have an intended life of up to two weeks, after which the device is intended to be discarded. Alternatively, the device can be discarded after each individual use and / or treatment. Other examples may provide such a wearable device, but for use at home or in other contexts and for different time durations. Some examples are characterized by a lack of external leads or lead wires, such that therapy electrodes and anchoring devices are all in a single housing, which may include a clip or may be used with adhesive tape for securing the apparatus in place.

[0058] The ICU is one example of a potential care environment. Others may include, for example and without limitation, hospitals generally, rehabilitation centers, pain management clinics, physical therapy clinics, neurology clinics, sports medicine clinics, chiropractic clinics, home health care settings, long-term care facilities including residential care or assisted living facilities, outpatient surgery centers, urgent care facilities, emergency rooms, convalescent homes, hospice centers, birthing centers, or any other medical care location or facility. The system and / or device may be provided as well for use in ambulances or other use cases, such as a first aid tent at a sporting event, outside of the controlled environment of a hospital or other care facility.

[0059] Moreover, in some embodiments, the system and / or device herein may be provided with an audio output device (e.g., a transducer or speaker). For example, the transducer or other type of audio output element can be positioned in one or both of the extending structures described herein. Hence in some embodiments an audio output device such as a speaker can be positioned on the first extending structure or the second extending structure. In such embodiments, the device can be provided with an absence of a nerve stimulating element (e.g., an absence of a nerve stimulating element on both the first and second extending structures). A circuit board, as described herein, can be configured to operate (e.g., turn on / off, alter volume, etc.) the transducer or other type of audio output element. For instance, the system / device herein may be manifested as an auditory ear bud including a transducer (with or without a sensor / stimulator element), such as a speaker.

[0060] While the example of Figures 2A-2C (and similarly Figures 3A-3C, 4A-4C, and 5A-5C) is described as having electrodes as vagus nerve stimulation elements, other devices, methods and / or modalities can be used. Examples may use any of optical stimulation with light sources (optical transducers) such as lasers (including vertical cavity emitting lasers) or light emitting diodes including, for example and without limitation, optical stimulation using wavelengths in the infrared, near- infrared, and / or visible spectrum. Other examples may use vibratory or acoustic stimulation with frequencies from relatively low levels (tens to hundreds of hertz) up to ultrasound frequency. Such stimulation may be described as mechanical stimulation, and may use a mechanical transducer to convert electrical energy to acoustic / vibratory energy using, for example a speaker or ultrasound generator. Some examples may use magnetic stimulation with electromagnetic fields generated using, for example, permanent magnets or electromagnetic sources such as one or more inductive coils or other magnetic transducers.

[0061] Some examples may be directed to non-therapeutic, sensory, and / or purely auditory devices, such as those including a speaker e.g., for the purposes of emitting sound or music to a user of the auditory devices and / or an electrical sensor. Some examples may include a sensor such as electrical, optical, and magnetic sensors configured to detect or sense galvanic skin impedance, heart rate, heart rate variability, oxygenation, movement or acceleration (e.g., an accelerometer and / or gyroscope), various signals such as nerve and brain signals (e.g., an electroencephalograph), and / or the presence of one or more molecules (e.g., optical or chemical sensors) and / or configured to sense molecules in or on tissue, among other types of sensors. The sensor can be configured to detect or sense one or more of the above mentioned elements, statuses, actions, or characteristics while the devices herein are inserted in an ear of a user.

[0062] Some devices disclosed herein, referred to sometimes as a clinical care device, are configured for use by a healthcare provider on a patient in the clinical, nursing care, or hospital environment (including the ICU or intensive care unit). Such configurations are achieved by having the device be fully self-contained and mounted at or in the ear of the patient. This configuration means that the patient cannot readily observe or monitor the emplacement and status of the device, insofar as a patient cannot see his or her own ear directly. The device is designed for compact and complete positioning in the ear so as to avoid interfering with other treatments and the surroundings in the hospital environment. The in-clinic version of the device may omit any patient-directed alert means (audible, tactile, etc.), such that the healthcare provider (nurse or physician, for example) is required to place, activate, and monitor the device. This configuration is distinct from a personal therapy device.

[0063] Some devices disclosed herein, referred to as a personal therapy device, are configured for use by the individual on herself. The personal therapy device configuration is achieved by including in the device design one or more of a wireless (such as Bluetooth) or wired coupling to a patient device, such as a smartphone, enabling the patient to monitor device status, including correct positioning / placement, therapy on / off, battery status, etc. The personal therapy device configuration may include, for example, audible or tactile mechanisms (vibration) for notifying the patient herself as to device positioning or status, as well as alerts such as when the device is activated, deactivated, or completes a therapy regimen. A personal therapy device, as contrasted with the clinical care device, may also include a replaceable or replenishable power supply, such as a rechargeable battery or a replaceable primary cell battery.

[0064] Illustrative devices may find use as an adjunct therapy to any treatment performed in a medical or other care environment, such as in clinic, in hospital (including ICU), and / or in nursing care. Treatments delivered with the illustrative devices may provide an antiinflammatory therapy as an adjunct to other therapies. Some illustrative contexts for such use include, for example and without limitation, post-stroke care, post-surgery care, etc. The device may be used for transitional care between in-clinic and out-of clinic care, as a stand-alone therapy or as an adjunct to continuing therapies. The device may also be used as a stand-alone therapy either within or outside of the clinical environment.

[0065] Figure IB shows a range of locations at which opposing forces can be applied to secure a device in position in the ear. Some examples herein provide a flexibility of positioning for different individuals, depending on anatomy. Not only are some ears larger or smaller, different features of the anatomy may vary in prominence and shape. Some examples may be described as anchoring the device in a desired position by a combination of an anchor arm that extends into the auditory canal, and an opposing force which rests against the rim of the concha. The rim of the concha may include, as illustrated in Figure IB, and proceeding in clockwise fashion, the anterior helix, the inferior crus of the antihelix, the anti-helix, and the antitragus, defining an angular range for positioning of the device. The positioning for a given individual may use any suitable portion of this rim of the concha, based on patient anatomy in particular, as the ear structures vary from one person to another.

[0066] In Figure IB, each line with arrows on an end thereof may serve to illustrate a position that can be used. Intermediate positions may be used as well. Opposing forces may rest against, for example, the anti-helix and auditory canal, the inferior crus of the anti- helix and the auditory canal, the region between the tragus and the anti- tragus, opposed to the inferior crus of the antihelix, the anterior helix and the antitragus, and the antitragus to the inferior crus of the antihelix. Illustrative devices may be positioned with opposing arms or other structures applying forces to opposed sides of the rim of the concha, which may be understood as being represented by the circle in Figure IB.

[0067] Figures 2A-2C are views of a first wearable vagus nerve modulation device 10. Figures 2A-2B are views of the wearable vagus nerve modulation device 10, while Figure 2C shows an exploded view of the wearable vagus nerve modulation device 10. The device 10 is adapted for placement relative to an ear of a patient. A housing 20 contains electronics and a power source configured for providing output therapy energy, which may come in various forms including, in some examples, electrical pulses or other waveforms. In some embodiments, the electronics comprises an output circuitry to provide power to the first vagus nerve stimulating element and the second vagus nerve stimulating element. Illustrative circuitry is shown and discussed relative to Figure 11, below.

[0068] The housing 20 has a length between a first end 22 and a second end 24, and a width between a first side or edge 26 and a second side or edge 28. The housing can be an elongated housing where the length between a first end 22 and a second end 24 is greater than the width in this example. For example, the length may be in the range of about 10 to about 60 millimeters, and width in the range of about 3 to about 30 millimeters, or more or less. The overall mass of the device 10 may be in the range of about 10 to about 50 grams, or more or less.

[0069] The device 10 includes a first extending structure 30 having a first end at the housing 20 and a second end apart from the housing 20. The first end of the first extending structure 30 can by coupled to or proximate to a proximal end of the carriage 80, as illustrated in Figures 2A-2B.

[0070] The first extending structure 30 has a length, generally in the range of about 3 to about 15 millimeters or more or less. At or near the second end of the first extending structure 30 is an anchor arm 44 extending laterally therefrom. Optionally, the second end of the first extending structure 30 may include a vaguest nerve stimulation element 46. In some examples, the device 10 may be characterized by the anchor arm 44 being configured to be positioned beneath the tragus when the device is placed. In some further examples, the anchor arm 44 is configured to be inserted into the external auditory canal of the patient, providing at least a first anchoring point for the device.

[0071] The first extending structure 30 can include a neck portion 33 located along the length of the first extending structure 30. For instance, the neck portion 33 can be located proximate or adjacent to the housing 20, as illustrated in FIGS. 3A and 5A. The neck portion 33 can have a smaller diameter than another portion or the remainder of the first extending structure 30. Stated differently, the neck portion 33 can form an indented portion of the first extending structure 30. In some embodiments, the neck portion 33 can be configured to provide an area into which tissue such as flaps of skin of the tragus and / or antitragus can overlay when the devices herein arc inserted into an car. For instance, the tragus and antitragus protrusions of the ear can desirably apply a force on the first extending structure 30 at the necked portion 33 such that the first extending structure 30 is securely retained in the ear (e.g., in the cavum) and / or an element located on the first extending structure 30 such as a first stimulating element is thereby affixed firmly against the ear (e.g., the cavum). The neck portion 33 can optionally be configured to rotate relative to the housing 20 and / or another portion or the remainder of the first extending structure 30. The degree of rotation of the neck portion 33 can be at least 15 degrees, at least 30 degrees, or at least 45 degrees, among other possibilities.

[0072] The housing 20 includes or is attached to a second extending structure 40 having a first end at the housing 20 and a second end apart from the housing 20. The first end of the second extending structure 40 can be coupled to the carriage 80. For instance, the first end of the first extending structure 40 can be coupled to an outer surface such as the lowermost surface of the carriage 80, as illustrated in Figures 2A-2B. The second extending structure 40 has a length which may be in the range of about 3 to about 15 millimeters, or more or less. The length of the second extending structure may be variable, for instance, due to the presence of a spring structure or other biasing member or structure to allow flexibility or variability in a length of the housing 20 when the device is placed within an ear of a patient.

[0073] A distance 31 between the first extending structure 30 and the second extending structure 40 can be adjusted. The distance 31 can be taken from a centerline or center point of each of the first extending structure 30 and the second extending structure 40, as illustrated in Figure 2B or can be taken from opposing surfaces of the first extending structure 30 and the second extending structure 40, as illustrated in Figure 3B. Hence, the distance 31 can refer to a distance between opposing faces of the respective first extending structure 30 and the second extending structure 40 and / or a distance between a central axis or respective center points of the first extending structure 30 and the second extending structure 40. The distance 31 can extend substantially along a longitudinal axis of the device 10. The distance 31 can be equal to a portion of the length of the device 10. The distance 31 can be adjustable or variable when the device 10 is placed within an ear of a patient. For example, the distance 31 may be in the range of about 2 to about 20 millimeters, when the device is inserted in an car of a patient (c.g., when at least a portion of the first extending structure 30 and the second extending structure 40 are inserted in an ear of a patient. The distance 31 can be varied by moving (e.g., longitudinally translating) the second extending structure 40 relative to the first extending structure 30. For instance, the first extending structure 30 may be fixed at a given longitudinal position and the second extending structure 40 may be configured to move (e.g., longitudinally translate distally relative to the first extend extending structure 30), as detailed herein. For instance, the second extending structure 40 may be configured to longitudinally translate responsive to actuation of an adjustment mechanism 81. Conversely, the first extending structure may be configured to longitudinally translate responsive to actuation of an adjustment mechanism 81, for example, when the first extending structure 30 is coupled to a proximal end of the carriage 80, and the second extending structure is coupled to the housing. Furthermore, both the first and second extending structures may be configured to longitudinally translate responsive to actuation by one or more adjustment mechanism 81 and carriages 80.

[0074] The adjustment mechanism 81, as detailed herein, can refer to an individual adjustment mechanism that is manifested as an individual component. Thus, the adjustment mechanism 81 can be configured to permit readily adjusting the distance 31, even when the device 10 is disposed in a patient (e.g., an ear of a patient). For instance, the adjustment mechanism 81 can be configured to permit a user (e.g., a patient) to adjust the distance 31 while the device 10 is disposed within an ear of the patient by actuation of the adjustment mechanism with a single hand (e.g., one or more digits on the single hand), as compared to some other devices which require any adjustment to be performed prior to insertion of a device in the patient and / or which require the use of two or more hands to adjust the device. That is, the adjustment mechanism 81 permits precise adjustment of the second extending structure’s position relative to the first extending structure’s position, ensuring optimal placement of the vagus nerve stimulating element(s) e.g., on the conchae cymba without the need of the user to remove the device from the ear. In examples, the adjustment mechanism 81 is used to generate forces on opposed sides of the rim of the concha (Figure IB), to thereby hold a device in a desired position relative to the ear. The adjustment mechanism 81 can be located at the first end 22 of the housing 20. Having the adjustment mechanism 81 be located at the first end 22 of the housing can promote aspects herein such as permitting a user to readily adjust the distance 31, even when the device 10 is disposed in an ear or a patient. For instance, the adjustment mechanism 81 can be located at the first end 22 of the housing 20 and a portion (e.g., first portion) of the adjustment mechanism 81 can be located outside of the housing 20, while another portion of the adjustment mechanism 81 can be located inside of the housing 20. The portion of the adjustment mechanism 81 that extends outside of the housing 20 can thus extend (e.g., in a substantially longitudinal direction) a distance away from the first end 22 of the housing 20. The portion of the adjustment mechanism 81 that extends outside of the housing 20 can be contacted by one or more digits on a hand of a user and the other portion of the adjustment mechanism can be configured to adjust or move the carriage 80 responsive to the contact. The portion (e.g., second portion) of the adjustment mechanism 81 that is inside the housing can be integral with or coupled to the carriage 80. For instance, as detailed herein, the second extending structure 40 can be coupled to the carriage 80. Thus, the movement of the carriage 80 can impart a corresponding movement in the second extending structure 40. For example, actuation of the first portion of the actuation mechanism 81 can directly or indirectly cause the carriage 80 to move, as detailed herein, thereby imparting a corresponding movement in the second extending structure 40 (e.g., in the same direction and magnitude as the movement in the carriage 80). One or more mechanisms 81 can be integral or coupled to more than one carriage 80 to impart movement on both the first and second extending structures.

[0075] As mentioned, in some embodiments the adjustment mechanism 81 can be integral with the carriage 80. For example, as illustrated in Figure 2A-2C and 3A-3C, the adjustment mechanism can be integral with the carriage 80. In such examples, the adjustment mechanism 81 can be located on a first end of the carriage 80. The first end of the carriage 80 refers to an end of the carriage 80 that is spaced away or least proximate to the first and second extending structures. Having the adjustment mechanism 81 be located on or integrally formed in the first end of the carriage 80 can promote aspects herein such as readily permitting a user to adjust the distance 31, even when the device 10 is implanted or disposed in an ear of a patient. For instance, the adjustment mechanism 81 can include a fixed protrusion extending radially from the carriage 80. Stated differently, the adjustment mechanism 81 can be formed of an integral fixed protrusion that extends from the carriage 80. For example, the adjustment mechanism 81 can be manifested as a raised surface or protrusion that extends (e.g., radially and / or longitudinally) a distance from the carriage 80, as illustrated in Figures 2A-2C. Other configurations of the adjustment mechanism 81 are possible. For instance, the adjustment mechanism 81 can be manifested as a recessed or indented portion of a surface (e.g., an indented portion in an end of a protrusion extending radially from the carriage 80), as illustrated in Figures 3A-3C.

[0076] As mentioned, in some embodiments the adjustment mechanism 81 can be a separate component that is coupled the carriage 80. For instance, the adjustment mechanism 81 can be a separate component that is coupled to a first end (e.g., that is spaced away from or least proximate to the first and second extending structures) of the carriage 80. For example, as illustrated in Figures 4A-4C and 5A-5C, the adjustment mechanism 81 can be a separate component that is coupled to the first end of the carriage 80. In such instances, the adjustment mechanism 81 can be a rotatable adjustment mechanism such as a rotatable wheel or rotatable lever. For instance, the adjustment mechanism 81 can be a rotatable adjustment mechanism including an annulus (e.g., annulus 93, as illustrated in Figures 4C and 5C), wherein the rotatable adjustment mechanism is configured to rotate about the annulus 93 relative to the carriage 80, the housing 20, or both the carriage 80 and the housing 20, as detailed herein. Hence, the rotatable adjustment mechanism (e.g., a rotatable lever or rotatable wheel) can be configured to rotate about a plane (extending through the annulus 93) that is normal to a longitudintional axis of the device 10 such that rotation of the adjustment mechanism imparts a force to cause longitudinal movement (e.g., translation) of the carriage 80, as detailed herein.

[0077] In some embodiments, the carriage 80, the actuation mechanism 81, and / or the housing 20 can include detents that are configured to predispose the carriage 80 to corresponding longitudinal positions along a length of travel (e.g., longitudinal translation) of the carriage 80. Employing detents can promote aspects herein such as promoting retention of the devices herein within an ear of a patient i.e., once the carriage 80 is disposed at a given longitudinal position corresponding to one or more of the detents. For instance, the presence of the detents can permit the carriage 80 to move between and be disposed in one or more fixed positions (e.g., three different longitudinal positions) to accommodate different sized cars (e.g., small, medium, and large sized cars) of various users of the devices herein.

[0078] The detents can be mechanical detents and / or magnetic detents (e.g., formed of two or more magnets including a magnet coupled to the carriage 80 and a magnet coupled to the housing 20). For instance, the carriage 80 can include detents located along one or more of the substantially longitudinally extending side surfaces of the carriage 80 and / or that are located along the elongated slot 98 or other aperture in the carriage 80. In some embodiments, the detents of the carriage 80 can be manifested as one or more substantially radially projecting arms or features. In some embodiments, the detents of the carriage 80 can be manifested as a series of undulating ridges (e.g., peaks and valleys disposed therebetween). The detents can be configured to predispose the carriage 80 to longitudinal positions associated with the valleys (e.g., at spaced intervals between adjacent valleys), while the peaks can be configured to provide a degree of resistance to the longitudinal movement (e.g., translation) of the carriage 80. The housing 20 can include one or more corresponding detents or projections that are configured to mechanically interfaces with the detents of the carriage 80. In some embodiments, the corresponding detents 89 can be manifested as one or more arms or projections or as a series of undulating ridges (e.g., peaks and valleys). In some embodiments, the corresponding detents 89 can be manifested as one or more pegs or projections, as illustrated in FIG. 4C.

[0079] As detailed herein, the carriage 80, the housing 20, or both the carriage 80 and the housing 20 can include detents that are configured to predispose the carriage to one or more longitudinal positions along a length of travel of the carriage 80. For example, FIG. 4C illustrates the presence of detents 88 along a substantially longitudinally extending surface of the elongated slot 98. In such instances, the housing 20 can have a corresponding substantially longitudinally extending surface with corresponding detents. For example, an interior surface (most proximal to the carriage 80) of an elongated peg 99 can include detents 89 that are configured to interface with (e.g., interference fit with) the detents 88 and permit the carriage 80 to be moved longitudinally between one or more positions at which the detents 88 of the carriage 20 and the corresponding detents 89 of the housing 20 predispose the carriage 80. In some embodiments, the location of the detents 88 of the carriage 80 and / or the location of the corresponding detents of the housing 20 can be varied for the locations in FIG. 4C. For instance, the detents 89 of the housing 20 can be located on one or both of the molded pieces 20 A, 20B. In other examples, the detents can be located on the adjustment mechanism 81, the housing 20, or both the adjustment mechanism 81 and the housing 20. For example, detents 88 can be located on the adjustment mechanism 81 along at least a portion of an exterior surface of the adjustment mechanism 81 and the housing 20 can include corresponding detents 89 that are configured to interface with the detents

[0080] 88 on the actuation mechanism 81. An example of alternative locations for the detents 88 and the corresponding detents 89, is indicated in FIG. 2A.

[0081] Alternatively, or in addition to varying the location of the detents 88 and / or the corresponding detents 89, the structures of the detents 88 and / or the corresponding detents

[0082] 89 can be varied. For instance, one of the detents 88 and the corresponding detents 89 can be manifested as a peg or projection, while the other of the detents 88 and the corresponding detents 89 can be manifested as a series of undulating ridges (e.g., peaks and valleys). For example, the detents 88 can be configured as a series of undulating ridges and the corresponding detents 89 can be manifested as one or more peg or projection that is configured to interface with the detents 88, as illustrated in FIG. 4C, or the detents 88 can be configured as a peg or projection and the corresponding detents 89 can be manifested as a series of ridges (e.g., peaks and valleys).

[0083] The housing 20 may comprise molded pieces 20 A, 20B assembled together. In this example, the first molded piece 20A may be an upper lid and a second molded piece 20B may have a lower container to which the upper lid attaches, collectively forming housing 20. In this example, the first extending structure 30 is shown to be integrally molded as part of the lower container 20B. Molded into the lower container 20B is an internal channel 85 configured to receive carriage 80. However, other configurations of the lower container 20B and the carriage 80 such as those having the internal channel 85 in a different location or an absence of the internal channel 85 are possible. In some examples, the carriage 80 and the upper portion (most proximate to the carriage) of the second extending structure 40 may be molded together as a singular piece for positioning into the internal channel 85. In some embodiments, the lower container 20B also includes an elongated aperture 125, situated between the first extending structure 30 and the first end 22 of the housing 20, for instance, as illustrated in Figures 3C, 4C, and 5C herein. In such embodiments, the carriage 80 can include a lower portion the extends through the aperture 125 to contact an upper portion of the second extending structure 40. Alternatively, an upper portion of second extending structure 40 can protrude through the aperture 125 away from the housing 20. In any case, the position of the carriage 80 in housing 20 (e.g., the position of the carriage 80 within the internal channel 85) is adjustable, and by virtue of the second extending structure 40 being coupled to carriage 80, the position of the second vagus nerve stimulating element 32 at the end of the second extending structure 30 is also adjustable. That is, the space between the first vagus nerve stimulating element 46 and the second vagus nerve stimulating element 32 is adjusted.

[0084] In some embodiments, the aperture 125 allows the second extending structure 40 to protrude through the lower container 20B and the internal channel 85 exceeds the length of the aperture 125, providing a guided pathway for the carriage 80 to slide within the lower container 20B. As a consequence of such configuration, the range of the carriage 80 movement can be limited to the extent that the second extending structure 40 can moveably slide within the bounds of the elongated aperture 125. This range of movement is illustrated, for instance, in pail by the arrow 29 in Figure 3B. By limiting such movement to the range allowed by the elongated aperture 125, manufacturing and assembly are made easier than if the housing had two components which slide together and apart, as controlling the maximum extent of movement is relatively simple. In an alternative example, rather than an aperture as shown in Figure 3B, the overall housing 20 may have first and second components that mate together in sliding fashion to allow the length of the housing itself to be varied.

[0085] In some examples, a shroud or cover can overlay a portion of or an entirety of the apertures described herein. The shroud or cover can be configured to prevent or mitigate ingress of material (e.g., liquids and / or particulate materials). The cover can be formed of a relatively thin and / or deformable sheet of material. Examples of suitable materials for the cover include various thermoplastics (e.g., polyethylene, polypropylene, polyvinyl chloride, Polyethylene Terephthalate, EVA (Ethylene Vinyl Acetate), Polyamide (Nylon), among others. Tn some examples, the cover can be located internal to the housing 20 and permit a component such as at least a portion of the carriage 80 to project through the cover to a location outside of the housing 80, for instance, to mitigate ingress of material into the housing 20.

[0086] During or subsequent to placement of the device in the ear of the patient, a position (longitudinal position) of the carriage 80 can be adjusted such that the second vagus nerve stimulating element 32 is positioned on a conchae cymba while the first vagus nerve stimulating element 46 is positioned desirably at the conchae caverna. Yet, in some examples, the second vagus nerve stimulating element 32 may be positioned at the conchae caverna. In this configuration, the second vagus nerve stimulating element 32 is not part of the second extending structure 40, but rather integrated into housing 20 or the first extending structure 30, enabling the second vagus nerve stimulating element 32 to be in contact with different areas of the conchae once device 10 is in position. In this example, the second extending structure 40 remains useful for stabilizing and securely attaching the vagus nerve modulation device 10 to the ear, regardless of whether an electrode is carried thereon. More generally, the carriage position can be adjusted so that the device applies force to opposed sides of the rim of the concha (Figure IB) to thereby hold the device in a desired position.

[0087] In some examples, the user may adjust the positioning of the second vagus nerve stimulating element 32 by manipulating a position of the carriage 80 with the housing 20 from outside of the device e.g., device 10. By enabling adjustment from outside of the device 10, the device 10 does not have to be removed from its previously secured location (e.g., within an ear). This form of manipulation also enables precise adaptation to individual ear anatomies, without compromising the stability of the device 10 placement as previously positioned. Adjustment of the carriage 80 in the housing 20 (e.g., within the internal channel 85 in the housing 20) may be done manually or via a spring-loaded mechanism. In the examples that use a spring-loaded mechanism, the mechanism can be compressed during device 10 placement in the ear and subsequently released to expand relative to a portion of the ear (e.g., the inferior crus, helix, or antihelix), effectively securing the device 10 in the ear. This expansion creates a counterforce against the conchae cavum, so that the first extending structure 30 is in contact against tragus and / or anti-tragus, or elsewhere in the rim of the concha (Figure IB), ensuring a snug fit. In some examples, the spring-loaded mechanism incorporates a latch system, allowing the device 10 to be locked in various positions between fully compressed and fully extended states. This allows further customization the fit and positioning of device 10 in accordance to the user’s ear anatomy and comfort preferences, while maintaining the device’s stability and effectiveness. In the manual configuration, users may adjust the positioning as needed including, but not limited to, using their fingers, tabs, hooks, loops, or pivoting levers. This adjustment can be done either before or after device 10 has been placed in the ear.

[0088] The second extending structure 40 may have a variable shape, allowing for bending to a desired angle, and / or may rotate or pivot, so that the device can be adjusted to fit the user’s ear. For example, Figure 10D illustrates a variable length and pivoting mechanical structure; in other examples the structure itself may be flexible.

[0089] As mentioned, in some examples, the housing 20 comprises molded pieces assembled together. For example, a first molded piece 20A may be an upper lid and a second molded 20B piece may be a lower container to which the upper lid attaches, thereby substantially forming the housing 20. Other manufacturing methods can be used. The first extending structure 30 may be a molded part of a lower container forming part of the housing 20, with the anchor arm 44 or a portion thereof included as part of the molding step, or attached thereto in a subsequent manufacturing step. Other assembly or manufacturing methods can be used.

[0090] The example shown here includes a first electrode 46 on the first extending structure 30, and a second electrode 32 on the second extending structure 40. There may be more than one electrode in each of these locations, as shown in further examples below. Some examples may omit one, the other, or both of electrodes 32, 46. Rather than electrodes at 32, 46, devices for creating other therapy outputs (transducers, for example, for optical, mechanical / vibratory, magnetic, thermal or other therapies) may be used, in which case at least one transducer may be positioned on the first extending structure 30 and / or the second extending structure 40. Desirably, the positioning and / or degree of insertion of the anchor arm 34 may be such that the electrodes 32, 46 come into contact with the skin in the ear of the patient. The anchor arm, or “wing” 34, located at the second end of the second extending structure 40 may have an expanded end portion coupled by a thinner portion coupled to the second extending structure. Stated another way, the radial dimensions of the anchor arm or wing 34 may extend outward beyond (e.g., be larger than) the radial dimensions of the extending structure 40, as shown for example by Figure 2B. The radial dimensions of the anchor arm or wing 34 may vary around its perimeter to form one or more edges or “lips” of varying size. The one or more ridges or lips of the anchor arm or wing 34 may be placed under the ridges and folds of skin formed by the helix, inferior crus, and antihelix. In some examples, when an illustrative device (e.g., the device 10) is placed in the ear, a portion of the anchor arm or wing 34 proximal to the helix may extend further than a portion of the anchor arm or wing 34 proximal to the inferior crus and antihelix, as appropriate to fit within the depths of skin folds formed by the helix, inferior crus, and antihelix. The curvature of the perimeter of the anchor arm or wing 34 may vary to optimally fit the curvature of the outer boundaries of the cymba formed by the helix, inferior crus, and antihelix. In some examples, the anchor arm or wing 34 may be rigidly coupled to the second extending structure 40. In some examples, the anchor arm or wing 34 may rotate relative to the housing 20. Rotation of the anchor arm or wing 34 may permit an improved fit to varying curvatures or differing geometries of the helix, inferior crus, and antihelix across users of the devices herein. The device 10 can be configured such that a distance between the first extending structure 30 and the second extending structure 40 is adjustable. For instance, adjustment of the distance between the between the first extending structure 30 and the second extending structure 40 can be adjustable via actuation or movement of the carriage 80. In such instances, movement of the carriage 80 can impart a corresponding movement (e.g., of the same magnitude and direction) in the second extending structure 40 and anchor arm or “wing” 34 e.g., as the anchor arm 34 is coupled to the first extending structure 40, which is coupled to the carriage 80. The device 10 can be configured such that the anchor arm or “wing”, 34, is positioned under any portion of the helix, inferior crus, and antihelix such that any portion of a ridge, or lip, of the anchor arm or wing 34 is held against the ear and resists dislodgement of the device 10 when a counter force is imparted against the tragus and antitragus when the carriage 80 is extended. As highlighted in Figure 2C, the anchor arm 44 may include an expanded or bulbous end portion coupled by a thinner portion to the first extending structure 30. While a bulbous end portion is shown, other shapes (oval, polygon, tapered, conical, etc.) may be used instead, and / or the end portion can be or include a foam material that can be compressed prior to placement, and then expands to secure the device in an anchored position. Alternatively, in other examples, the anchor arm 44 may have a consistent or tapered outer profile from its connection to the first extending structure 30 to its tip. The anchor arm 44 and end structure 38 may be a unitary or single piece, and may be hollow to allow audio signals to pass therethrough. In some examples, a speaker may be integrated into the device to deliver audio signals. The anchor arm 44 may also include one or more electrodes thereon. The anchor arm 44 and / or end structure 38 may be provided as a detachable / replaceable piece that can be selected from a range of sizes or shapes. In some examples, the anchor arm 44 and / or end structure 38 thereof may be formed of a compliant material to conform to the space under the tragus and / or inside the auditory canal.

[0091] The anchor arm 44 may extend at an angle relative direction of the length of the housing. The angle can be about ninety degrees, but in other examples it is envisioned that the angle can be in the range of about 60 to about 120 degrees, or about 70 to about 110 degrees, or about 80 to about 100 degrees. In an example, the angle of the anchor arm 44 may be adjustable, if desired, such as by use of a click-mechanism or flexible material to allow the anchor arm 44 to twist about the first extending structure 30. In still another example, the first extending structure 30 may be adjustable to twist about, for example, a central core (e.g., necked portion 33), entirely or through a limited range of motion such as (using the angle of the anchor arm as a guide) between about 60 to about 120 degrees, or more or less as desired. In the illustrative example shown in Figures 2A-2C, 3A-3C, 4A- 4C, and 5A-5C, the position of the anchor arm 44 is fixed. One or more stops may be included to limit the translation, extension or rotation of the anchor arm 44, to the extent it is adjustable. The first and second extending structures 30, 40 may likewise be adjustable in terms of translation, extension / retraction and / or rotation, as desired.

[0092] If desired, one or more through-openings or holes may be provided in the anchor arm 44 to allow air ingress / egress, facilitating hearing for the patient by avoiding complete blockage of the auditory canal. The anchor arm 44 may further include one or more electrodes and / or transducers, either for therapy purposes or to enable or augment hearing of a patient. For example, a speaker may be provided, allowing the patient / user to hear audible indications of device and / or therapy status, to amplify sounds (as with a hearing aid), or to provide entertainment or communications to the patient / user.

[0093] In first example, when the device 10 is placed relative to the ear of the patient, the anchor arm 44 is positioned to extend beneath the tragus, while the electrode 32 is positioned at (i.e. in contact with) the conchae cymba, and the electrode 46 is positioned at (i.e. in contact with) the conchae caverna. In second example, when the device 10 is placed relative to the ear of the patient, the anchor arm 44 is positioned to extend beneath the tragus, while the electrodes 32, 46 are on opposing sides of the crus helix. In a third example, when the device 10 is placed relative to the ear of the patient, the anchor arm 44 is positioned to extend into the auditory canal, while the electrode 32 is positioned at (i.e. in contact with) the conchae cymba, and the electrode 46 is positioned at (i.e. in contact with) the conchae caverna. In an example, when the device 10 is placed relative to the ear of the patient, the anchor arm 44 is positioned to extend into the auditory canal, while the first and second electrodes 32, 46 are on opposing sides of the crus helix. These examples are not intended to be an exhaustive list of descriptions of the device positioning. In illustrative examples, the device may be held in position using opposed sides of the rim of the concha, as shown in Figure IB.

[0094] The electrodes 32, 46 may each have a surface area in the range of about 20 mm2to about 100 mm2, or more or less. In some examples, each electrode as an area in the range of about 25 nun2to about 80 mm2. The electrode 46 may be larger than the electrode 32 in some examples, allowing stimulation to be more targeted to the region of the electrode 32 by increasing the current density in the vicinity of the electrode 32. The space or gap (edge to edge) between the electrodes 32, 46 may be in the range of about 2 mm to about 15 mm, or more or less. For example, electrodes 32, 46 may be about 5 mm to about 10 mm apart (edge to edge). Voltage and / or current controlled output waveforms may be used, as further described below. In some embodiments, the electrodes herein (e.g., the electrodes 32, 46) may be textured for instance to etching, scoring, pitted, porous, or comprised of one or more partially compressed strands. Employing textured electrodes (with a textured surface) can increase the surface area of the electrodes, thereby, decreasing intcrfacial impedance with the skin or interference through an applied conductive gel.

[0095] In some embodiments, the device 10 can be affixed to the ear in an absence of a clip, tape, and / or another type of attachment mechanism. For instance, as illustrated in Figures 2A-2C, the device 10 does not include a clip or adhesive tape. Instead, the device can be secured in place by the extending structures themselves and the anchor arms 44 and 34. The second extending structure 40, in some embodiments, aids in holding the device by having a variable length, using, for example, a spring loaded or otherwise adjustable connection between the upper part and lower part thereof, holding the electrode 32 on the skin of the patient while the anchor arm (or “wing”) 34 of the second extending structure 40 holds the device in a desired position and secures the placement of the electrode 32. For instance, abutment of the second extending structure to a first portion of an ear (e.g., the inferior crus and antihelix) creates an opposing force to the first extending structure positioned against a second portion of the ear (e.g., the antitragus). Additionally, in some embodiment abutment of the anchor arm or wing of the second extending structure in the ear (e.g., beneath the anterior fold of the helix superior to the tragus) creates an opposing force to posterior rotation of the device relative to the ear, as does abutment of a portion of the anchor arm or wing of the second extending structure in the ear (e.g., beneath the fold of the inferior crus and / or antihelix). Optionally, the examples herein can also include a clip (not illustrated), adhesive tape, or other for clipping the device 10 into a desired position in the ear of a patient.

[0096] Thermal stimulation may include heating of the nerve; heating may be achieved either by issuing higher frequency signals (RF heating), or by the use of a resistive heating element, for example and without limitation, wherein the resistive heating element may serve as a thermal transducer. Cooling may be provided, such as by having a removeable / replaceable thermal element that can be placed in a refrigerator prior to use, by including a Peltier cooling apparatus, or by having channels allowing cooling fluid to be circulated, either of which may be a thermal transducer. Thus, rather than the electrodes described above, one or more transducers can be used to convert stored power (usually electrical power from a battery) to a different energy modality. Each of these methods offers unique advantages and may be tailored to specific applications based on factors such as precision, invasiveness, and compatibility with the nerve tissue. For example, optical stimulation offers precise control over the timing and location of nerve activation. Acoustic and magnetic stimulation techniques can penetrate deeper tissues and may be non- invasive, making them suitable for certain clinical scenarios. Thermal stimulation, on the other hand, can modulate nerve activity by altering temperature gradients within the tissue.

[0097] In some examples, a combination of modalities can be used. For example, thermal stimulation may be generated by the use of higher frequency (RF) outputs from electrodes, paired with lower frequency pulsed electrical field outputs at frequencies in the tens to hundreds of hertz. Such signal combinations may be delivered in an overlapping or simultaneous manner, or the device may cycle between one therapy mode and another, as desired. Electrical stimulation can also be paired with magnetic, acoustic / vibratory, and / or optical stimulation. Other combinations can be used as well.

[0098] Separate therapy may also be provided, such as with the delivery of antiinflammatory or other medications to the patient along with the issuance of stimulation signals, or by also providing circulatory or respiratory support to the patient and / or additional stimulation signals, or thermal controls such as inducing therapeutic hypothermia or other temperature management. In some examples, therapy combined with an analgesic to ensure that the patient will not feel the therapy delivered by the stimulation device. An analgesic may be systemically delivered (injection, oral, etc.) or may be locally delivered such as by elution from the electrode surfaces or by using a gel or liquid containing analgesic substances (such as lidocaine) on the electrode surfaces.

[0099] The device may coordinate therapy delivery with other actions. In some examples, the device may be commanded to start a therapy session, while another therapeutic activity is ongoing, such as having the patient engage in a memory game or other activity while therapy is being delivered. Coordinated timing can be facilitated by use of the controls on the device itself, or the device may include communications circuitry (such as a Bluetooth or Bluetooth Low Energy antenna and chip) to communicate with a programming device or smartphone having counterpail communications circuitry; an application operating on the programming device or smartphone can be used to start therapy at a desired time and / or otherwise operate the devices herein (e.g., to cause a speaker in the device to emit sounds or music). Other coordination may include the use of biological signals. Heart rate, for example, can be monitored by the device itself (such as by adding or including an earlobe clip), or by a second device such as a cardiac monitor; when the heart rate is above a threshold, such as a threshold in the range of 100 to 140 beats per minute (or other setting), the patient may be experiencing a high degree of inflammatory response, so therapy can be turned on in response to elevated heart rate. On the other hand, if the heart rate becomes bradycardic, such as below about 40 to 60 beats per minute, therapy may be stopped. In another example, pupillometry can be used to turn therapy on or off by obtaining an image of the eye, using a smartphone or other device having a camera, and modulating or turning therapy on or off in response to the results of such measurements. Synchronization to other therapies, including physical therapy, drug delivery, or any other intervention can be useful to augment the patient’s response to other therapies by Vagus nerve stimulation.

[0100] The nerve stimulation elements of the device can be designed to be modular, allowing for easy customization and adaptability to individual patient needs. This feature enables healthcare professionals to easily change out the stimulation elements as necessary, providing a tailored and optimized treatment plan for each patient. The modular design enhances the versatility and flexibility of the device, ensuring that it can be easily adjusted to accommodate different therapeutic and anatomic requirements. This approach enhances the clinical utility of the device, offering a personalized and effective treatment option for patients with varying neurological conditions. Modularity may be provided by, for example, providing aspects of the device housing and / or neural stimulation elements in the system in a range of sizes or types. For example, if electrodes are used to issue electrical stimuli, the electrodes may come in different sizes (surface areas) and / or shapes, which may be selected and / or replaced. Aspects of the housing and the extending structures can also be adjustable or replaceable to accommodate different anatomies (larger or smaller ears), including, for example, pediatric sized systems for smaller ears. The system itself may come in a range of sizes, if desired.

[0101] The device may be programmable or reprogrammable, such as by plug-in-type attachment to a port located on the device, or by use of magnetic / inductive, wireless (RF, such as Bluetooth) communication, optical communication, or by having one or more buttons, dials, or other user-accessible controls accessible on the device. To this end, as discussed further below with reference to Figure 1 1 , a communications circuitry may be included in the device.

[0102] The materials used throughout may include any material suitable for skin contact for an extended period of time (hours, days or even weeks). For an electrical stimulation system, the electrodes 32, 46, for example, may be made of any of graphene, titanium, nickel titanium (nitinol), platinum, platinum-iridium, gold, silver, stainless steel (including MP35N alloy) or any other metal or conductive polymer or other material that can be worn on the skin. Coating layer(s) may be provided to optimize tissue interface characteristics, as desired. As illustrated in Figures 10A-10D, below, the electrodes may be configured to receive or carry thereon a conductive material, such as a gel, hydrogel, or other tissue interface component. Pads may be attached if desired. Alternatively, dry electrodes can be used, if desired. The other tissue contacting portions of the device 10 may be made of suitable plastics, silicone, etc. adapted for wear on the skin of a patient / user.

[0103] Biocompatible materials may be selected to enhance conduction of the therapy signal between the electrode or therapy generating element and the tissue (electrical conduction, mechanical conduction, optical transmission, etc.). Biocompatible materials may also be selected to enhance adhesion of the therapy generating element and the tissue. Biocompatible materials may also be selected to provide an analgesic effect to suppress perception of the therapy. All types of materials may also be combined into a single material. Materials may be attachably and detachably connected to the therapy-generating element. For example, hydrogel pads may be replaced. In cases of wet materials, one or more moisture barriers (e.g. metal foil) may be used for packaging and temporarily adhered over the material to preserve functionality for extended shelf life. In other examples, materials may be separately packaged within a preserving pouch, packet, or container and applied prior to use. In some cases, the material may include a barrier material or membrane that is removed prior to use. In some cases, the barrier material or membrane may include extensions, tabs, buttons, or other structures to aid in handling the material while attaching the material or removing the material from the device.

[0104] The housing 20 optionally includes indicator lights such as progress indicator lights and / or alert lights. If desired, a speaker may be included in or on the housing 20 as well and used for issuing audible alerts, instructions for use, device status, or other purposes such as for providing an audible signal for entertainment or relaxation purposes (playing music for example). The progress indicator lights may be light emitting diodes (LEDs) or any other suitable light generator, as desired. Upon powering the device, it may take some period of time (seconds to minutes) for electronic circuits to convert voltage levels from the power source (e.g. battery) to levels suitable to power the therapy driving sub-circuits. For example, a boost converter, or inverter may require time to charge up capacitors, or circuit elements that can supply voltage and or current draw more readily than a battery (e.g. coin cell, which has a limited voltage and current draw). An indicator may be used to indicate when the device is ready for use, such as when a capacitor used for storing power to be used in therapy is charged to a desired level. As the device is preparing itself, a different indicator may be used, such as having a flashing or blinking light during preparation of the device, which turns solid once the device is ready.

[0105] In some embodiments, the device 10 can include one optical indicator for providing an indication of a state of the wearable vagus nerve modulation device. For instance, the at least one optical indicator can be manifested as a multi-purpose light-emitting diode configured in a ring 351. The ring 351 can be formed of a plurality of respective progress segments to indicate a device status and stimulation progress during a therapeutic stimulation session, as illustrated in Figures 8A-8B and 9A-9B.

[0106] Electrical output therapy parameters may include, for example, issuance of square wave pulses that are either current-controlled or voltage controlled, as desired, issued at a pulse repetition rate in the range of about 1 to about 200 Hz, or about 10 to about 50 Hz, or about 20 Hz, 30 Hz, or 40 Hz, or more or less. Frequency may be adjustable or selectable, or it may be fixed. Current controlled pulses may be, for example, issued at an amplitude in the range of about 0.1 mA to about 20 mA, or about 0.4 mA to about 12 mA, or about 8 mA. Voltage controlled pulses may be, for example, in the range of about 1 mV to about 15 V, for example and without limitation. Peak voltages, either stored within the device or used for therapy outputs, may be in the range of up to about 50 V or higher.

[0107] Current or voltage may be adjustable, if desired, such as by providing wireless control in which the device 10 contains a transceiver, such as a Bluetooth chip and antenna, to be programmed by an external device such as a smartphone or tablet operating an application dedicated to the vagus nerve system. Alternatively, or in addition, in some embodiments the devices herein can include a port configured to receive a cable or a cord that can communicatively couple the devices herein to another device (c.g., a smartphone) that is configured to operate the devices herein. Other communication means can be used, including optical, magnetic / inductive, vibratory, etc., as desired. Alternatively, one or more buttons on the device may be used to increase or decrease output amplitude, as desired; additional indicators on the device may be used to allow amplitude settings to be determined visually. Some systems may, on the other hand, be pre-programmed with limited or no therapy adjustments available.

[0108] Electrical pulses may be delivered using, for example a pulse width in the range of about 10 microseconds to about 20 milliseconds, or more or less; pulse width may be adjustable or selectable, as desired. Some examples may use pulse width in the range of about 100 microseconds to about 500 microseconds. An illustrative example uses a pulse width of 250 microseconds, repetition rate of 20 Hz, and amplitude of 8 mA, delivered in a 20-minute session, once a day or twice a day, for up to two weeks, for example. More frequent sessions, or less frequent sessions, and shorter or longer sessions, and / or longer or shorter regimens (one day to several weeks, for example) may be used. For example, twice-daily, once-daily, or alternating day therapy can be used for period of weeks or months, or longer, depending on patient needs.

[0109] Other signals may be used, including burst outputs (having closely grouped pulses in time separated by longer quiescent periods), or shaped outputs (triangular, ramped, descending, etc.) and / or sinusoidal signals. Some examples deliver stimulus using a waveform without any underlying carrier wave. Others may use, for example, a carrier wave in with a frequency in the kHz to MHz range. Interferential stimulation may be used as well, in which two therapy signals (such as sinusoidal outputs) are delivered at different frequencies, resulting in the effective delivery of a beat frequency (the difference between the therapy signal frequencies) arriving at target tissue.

[0110] In some examples, a subperception therapy is delivered. For example, with an adjustable electrical stimulus system, any of amplitude, pulse width, or repetition rate may be adjusted until paresthesia (tingling) or other sensations are observed / reported by the patient, and then the controlled parameter (amplitude, pulse width, or repetition rate) is reduced. In one example, amplitude is increased until paresthesia is observed, indicating that the sensory threshold has been reached, and then therapy amplitude is set by reducing the amplitude by a fixed amount or a percentage relative to the sensory threshold. Pulse width may be increased until paresthesia is observed, indicating that the sensory threshold has been reached, and then pulse width is set by reducing by a fixed quantity or percentage. Other combinations may be used to achieve a sub-perception therapy. Supra-perception therapy may be used if desired, as a way of providing the patient feedback that the therapy is on and in use.

[0111] In some examples, therapy may be set by use of a population-based control and / or controls adjusted using patient characteristics. Closed loop sensing may not be available for some systems. A therapy setting for any of electrical, optical, mechanical (acoustic or vibration), and / or magnetic stimulation can be selected using amplitude, frequency / wavelength and / or other characteristics after testing in a population of test subjects. The therapy setting may be chosen provide effective therapy with minimized side effects based on the results of such testing.

[0112] Some of the preceding examples indicate the use or possibility of reshapeable first extending structure 30 and / or second extending structure 40, or an anchor arm 44, or an anchor arm 34, which are reshapeable. Other examples make each of these pieces a rigid element not allowing for reshaping. In some examples, a rigid second extending structure 40 has a spring or other resilient member therein allowing the length to vary in response to patient anatomy. The device may then be placed by inserting the anchor arm 44 with its end in the auditory canal of the patient, and then twisting the device to bring the second extending structure into contact with the conchae cymba. The twisting movement may be as indicated by arrow and line 260 in Figure 6, below, until the second extending structure 40 or attached anchor arm (or “wing”) 34 abuts the crus helix or antihelix, as explained relative to Figure 6.

[0113] Figures 3A-3C are views of a second wearable vagus nerve modulation device 11. The second wearable vagus nerve modulation device 11 is analogous to the first wearable vagus nerve modulation device 10 with the change that the adjustment mechanism 81 and components associated therewith (e.g., in contact therewith) are different. For instance, as illustrated in Figures 3A-3C, the adjustment mechanism 81 can include a protrusion 82 extending radially from the carriage 80 in a second direction (toward the first molded piece 20A), whereas the adjustment mechanism 81 of the first wearable vagus nerve modulation device 10 is a protrusion 82 extending radially from the carriage in a first direct (away from the first molded piece 20 A). Moreover, the adjustment mechanism 81 of the carriage 80 can be the first end 22 of the second wearable vagus nerve device 11, whereas the first end 22 of device 10 can be formed of the housing 20 (e.g., the carriage can move distal to the first end 22 of the device 10). Additionally, the protrusion forming the adjustment mechanism 81 of the second wearable vagus nerve modulation device 11 can have an indented or recessed portion configured to be contacted by a user, whereas the protrusion forming the adjustment mechanism 81 of the first wearable vagus nerve modulation device 10 can be a tab with planar surface that is configured to be contacted by the user.

[0114] Further, the carriage 80 of the second wearable vagus nerve modulation device 11 can include an extended portion 39 configured to extend through an elongated aperture 125 formed in the second molded piece 20B of the housing 20. The extended portion 39 can be configured to be inserted in and coupled to the second extending structure 40 e.g., via a friction fit or interference fit of tabs or ribs located on an end or other portion of the extended portion 39 within an opening in the second extending structure 40. In contrast, second molded piece 20B of the housing 20 of the first wearable vagus nerve modulation device 10 does not include an elongated aperture 125. Instead and as mentioned, the carriage 80 of the first wearable vagus nerve modulation device 10 can be located within the channel 85 formed in an exterior bottom surface of in the second molded piece 20B of the housing 20 and the second extending structure 40 can be coupled directly to a substantially planar surface of the carriage 80, as illustrated in Figures 2A-2C.

[0115] Figures 4A-4C are views of a third wearable vagus nerve modulation device 12, while Figures 5A-5C are views of a fourth wearable vagus nerve modulation device 13. The third wearable vagus nerve modulation device 12 and the fourth wearable vagus nerve modulation device 13 are analogous the first wearable vagus nerve modulation device 10 with the change that the adjustment mechanism 81 and components associated therewith (e.g., in contact therewith) are different. For instance, Figures 4A-4C illustrate embodiments where the adjustment mechanism is manifested as a rotatable lever, while Figures 5A-5C illustrate embodiments where the adjustment mechanisms is manifested as a rotatable wheel. Hence, each of Figures 5A-5C illustrate embodiments wherein the adjustment mechanism is manifested as a rotatable adjustment mechanism.

[0116] The rotatable adjustment mechanisms may be rotatable, at least partially, about an annulus 93 and / or a peg 104 disposed in the annulus 93. The range of rotation may be anywhere from about 10 degrees to about 360 degrees. For instance, the rotatable lever illustrated in Figures 4A-4C and the rotatable wheel illustrated in Figure 5A-5C may have a range of rotation that is in a range from about 10 to about 50 degrees. Each of the rotatable lever and the rotatable wheel may include a portion that is exposed from the housing 20 (e.g., a lever or a portion of the wheel) can is configured to be contacted by a user to impart rotation of the rotatably adjustment mechanism. That is, the housing 20 can include a slot or opening 90 at an end of the housing 20 that permits the wheel or the lever to protrude (e.g., in a substantially longitudinally direction) and extend a distance from the housing 20, while another portion of the adjustment mechanism 81 is disposed in the housing. For instance, the lever or a portion of the wheel can extend extending laterally through the slot 90 to a position outside of the housing 20, thereby permitting a user to actuate (rotate) the rotatable adjustment via contact with the lever or portion of the wheel outside of the housing 20.

[0117] As mentioned, the second extending structure 40 can be coupled to the carriage 80. As illustrated in Figures 4A-4C and 5A-5C, the carriage 80 of the third and fourth wearable vagus nerve modulation devices 12, 13 can include an extended portion 39 configured to extend through an elongated aperture 125 formed in the second molded piece 20B of the housing 20. The extended portion 39 can be configured to be inserted in or around and otherwise be coupled to the second extending structure 40 e.g., via a friction fit or interference fit of tabs or ribs located on an end or other potion of the extended portion 39 within an opening in the second extending structure 40. These are merely examples, alternate or additional mechanisms of coupling the components herein are possible such as coupling components together via a first connector (e.g., male connector) associated with or integral with a first component and a second corresponding connector (e.g., a female connector) associated with or integral with a second component, via a latch and / or pin in conjunction with a corresponding aperture, etc. are possible. Continuing with the description of Figures 4A-4C and 5A-5C, the portion of the adjustment mechanism 81 that is disposed within the housing can include a notched or tooth structure (e.g., notches 94 as illustrated in Figure 4C) that is configured to interface with (interference fit with) a corresponding notched or tooth structure (e.g., notches 92 as illustrated in Figure 4C) on the carriage 80. Hence, rotation of the rotatable lever or rotatable wheel in a given direction (e.g., in the direction 73) and be translated via the interface between the corresponding notched or tooth structures to impart longitudinal movement (e.g., in the direction 75) of the carriage 80. For instance, rotation of the wheel or lever in a first direction can impart movement of the carriage 80 longitudinally toward the first extending structure 30, while rotation of the wheel or lever in a second direction (opposing the first direction) can impart movement of the carriage 80 longitudinally away from the first extending structures 30. Thus, rotation of the lever or wheel permit a user to readily adjust that distance 31 between the first extending structure 30 and the second extending structure 40.

[0118] For instance, the lever can rotate from a first position (at a first end of the slot extending through the first end of the housing), as illustrated in Figure 4A, to a second position at a second end of the slot extending through the first end of the housing 20 that is opposite the first end of the slot), as illustrated in Figure 4B. Similarly, the wheel can include a curvilinear slot 91 extending within a portion of the wheel. In such instances, a first end or portion of another peg or projection element (not shown) can be disposed within the curvilinear slot 91 and a second end of the peg or projection can be fixable coupled to the housing 20 such that the peg or projection can limit the degree of rotation of the wheel. For instance, the wheel can be configured to move between a first position (where the peg or projection is located at a first end of the curvilinear slot), as illustrated in Figure 5A, to a second position (where the peg or projection is located at a second end of the curvilinear slot opposite the first end of the curvilinear slot, as illustrated in Figure 5B.

[0119] In some embodiments, a spring or other mechanism can disposition the carriage 80 of any one of the devices 10, 11, 12, or 13 to given position. When present, the dispositioning mechanism can be coupled to the carriage 80 or the adjustment mechanism. For instance, the dispositioning mechanism can be a spring that is directly coupled to the carriage 80 (e.g., having one end coupled to the carriage and another end coupled to the housing), among other possibilities. Similarly, in some embodiments the dispositioning mechanism can be a spring. The disposition mechanism (not shown) can be configured to disposition the carriage 80 to a longitudinally extended position or can be configured to disposition the carriage to a longitudinally contracted position.

[0120] In some embodiments, the carriage 80 can include an elongated slot 98 extending longitudinally along a portion of the length of the carriage 80. In such embodiments, a projection or peg can be configured to be slidably disposed within the elongated slot 98. For instance, the lower lid 20B can include an elongated peg 99 or other shaped protrusion configured to extend into the elongated longitudinal slot 98, as illustrated in Figure 4C. The presence of the elongated slot 98 and the corresponding protrusion or elongated peg 99 can promote aspects herein such as ensuring that the carriage 80 is configured to translate in a substantially longitudinal direction within the housing 20.

[0121] Figure 6 illustrates placement of a wearable vagus nerve modulation device. The device 250 includes an anchor arm 252. A button 254 is provided for use in activating, pausing or stopping therapy. A tap design, rather than button 254, may be used if desired. Indicator LEDs may be provided at 256 and / or 258. Alternatively, or in addition, the device 250 can include a progress ring (e.g., the progress ring 351 as illustrated in Figures 8A-8B and 9A-9B, herein). It may be noted that while the indicator lights 256 / 258 may be useful in the context of a patient having a caregiver, these may be of less utility for a patient using a device 250 at home. A speaker may be used to provide audible indications of status, such as by inclusion on the anchor arm 252 or elsewhere on the device. Alternatively, or in addition to the progress ring and / or other controls or indicators depicted on the device 250, a separate device such as a smartphone, tablet, or laptop computer, etc. and / or a special purpose programmer or patient device may be coupled in a wired or wireless manner to the device 250. This device may be configured with a software and / or firmware to communicate with the device 250. For instance, the device may be configured to control and / or monitor aspects of the device 250 such as starting, stopping, and / or otherwise modifying operation (e.g., therapeutic operation) of the device 250.

[0122] The system of Figure 6 is illustrated and described as providing electrical stimulation, though other modalities of therapy can be used instead. The device 250, with anchor arm 252, and first and second electrodes as in any of the preceding versions of a wearable vagus nerve modulation device, will be placed as indicated by the arrows. The anchor arm 252 passes behind the tragus, and / or into the auditory canal. This brings the first electrode to the position marked Electrode A, and the second electrode to the position marked Electrode B. Such positioning would also put the first electrode on / at the conchae caverna, and the second electrode on / at the conchae cymba. In other examples, one or the other of the electrodes may be differently placed, and / or more than two electrodes can be used; thus, in various examples, the device may be held in position using opposed sides of the rim of the concha, as shown in Figure IB. Further, rather than electrodes, other vagus nerve stimulation elements may be used, as desired, singly or in combinations.

[0123] As indicated by line / arrow 260, in several examples the device may be positioned by inserting the anchor arm 252 into the auditory canal, and / or beneath the tragus, and then twisting the device. Some examples may twist the device in a superior / anterior direction, bringing the second extending structure (not shown, but carrying Electrode B in several examples) into a position abutting the anatomy of the exterior of the ear, such as a superior portion at the posterior edge of the crus helix, marked at 262. This positions the housing more vertically in the ear, with the end opposite the anchor arm 252 near the superior helix. Other examples twist in the opposite direction, in an inferior / posterior direction, bringing the second extending structure (again, not shown, but carrying Electrode B in several examples) into a position abutting the anatomy of the exterior of the ear, such as the antihelix, as indicated at 264. Whether the device is twisted or not, once placed within the ear, expansion of the extending structures creates force between portions of the boundary of the cavum (ear canal, tragus, and antitragus) against portions of the boundary of the cymba (helix, crus of helix, and antihelix) to secure the device within the ear.

[0124] This twisting step highlighted at 260 works the device into a desired position, and can be performed by the patient or a caregiver, such as an ICU nurse, in a simple, quick installation step. In some examples, no molding, curing or reshaping is needed. Because the second extending structure has a variable length, such as by including therein a resilient member or spring, such twisting allows the device to more or less automatically achieve a desirable position in which the electrodes or other actuator(s) are positioned against the patient’s skin. An adhesive strip, such as tape or other substrate material, can be added if needed to maintain device positioning, however it is envisioned that an additional piece of tap will not be needed for most patients, again simplifying the use of the system for the patient and medical personnel.

[0125] Optionally, if a clip is used, the clip would pass over the helix, for example at a superior or posterior location, or elsewhere and / or in-between, to hold the device in place. Optionally, if tape is used, the tape may extend to and over the region marked superior helix, extend to and over the region marked posterior helix, or elsewhere.

[0126] Regardless of the optional clip or tape inclusion, the device 250, using the anchor arm 252 and the extending structures described herein, is configured for placement such that the entire device, in some examples, is positioned inside the periphery of the ear, with no wires extending therefrom. In other examples, a wire does extend out to a return electrode positioned elsewhere on the patient, such as the torso or neck, if desired. In some examples, only a single device 250 is present in the system, omitting a second device positioned on the other ear. The device 250 may be configured for positioning on the left ear, as may be inferred from Figure 6. Alternatively, the device may be configured for positioning on the right ear, if desired.

[0127] Some examples may include two devices 250 that are separately positioned, without mechanical / electrical contact therebetween, one for each ear of a patient. For such as “two-device” system, therapy can be delivered independently by each device, in some examples. In other examples, may be coordinated such as by providing wireless communication circuitry in each device so that the two devices can communicate with one another to coordinate therapy delivery, or so that each device can communicate with a programming device, such as a dedicated programmer or a user’s smartphone (operating an application specific to the system) that communicates with each device to synchronize therapy delivery. “Synchronized” therapy may include any of delivering therapy with pulses delivered at the same time, or with pulses interleaving, or with pulse trains overlapping, or with pulse trains from each device alternating with one another so that only one device is actively issuing output at any given time, or actively issuing an output pulse train at any one time.

[0128] Other examples may use a very lightweight version of the device 250, omitting electronics therein, and coupling to a separately positioned pulse generator such as by wired connection thereto, where the output of the pulse generator provides power and defines the pulsed outputs of the device.

[0129] Figures 7 is a side section views illustrating electrode contact and mechanisms for securing a wearable vagus nerve modulation device to the ear. In Figure 7, a device 300 is shown secured to the patient’s ear. Due to the capability of the devices herein to vary a length thereof (e.g., a variable length between the first and second extending members), in some embodiments the wearable vagus nerve modulation devices herein can be secured to the patient’s ear in the absence of another element (e.g., tape or other type of additional element). However, in some embodiments, tape or another type of adhesive element can optionally be attached to the device 300 and the superior helix 320 to promote retention of the wearable vagus nerve modulation device in the ear. In some embodiments, the device is sized and shaped so that when positioned as shown, the first electrode 312 is positioned at the conchae caverna 324, and the second electrode 314 rests against tissue at the conchae cymba 322. The positioning can also be characterized as having the first electrode 312 and second electrode 314 positioned on opposing sides of the crus of helix 326. In illustrative examples, the device may be held in position using opposed sides of the rim of the concha, as shown in Figure IB. Further, due to the capability of the devices herein to vary a length thereof, in some embodiments the wearable vagus nerve modulation device can be secured to the ear without any of an additional anchor arm, clip, and adhesive tape.

[0130] Illustratively, and without limitation to a particular layout, the device 300 is shown having a printed circuit board 302 therein, coupled by feedthrough or other wires (not shown) to the alert indicators 304, on / off / pause button 306, first electrode 312 and second electrode 314. A stack of battery cells 308, which may be standard button cells or may be a custom design, is contained in this example in the first extending structure 316. Other layouts and battery types can be used; any number of battery cells may be used, though it is expected generally that one to three cells would be used. The device may be a single use device (where single use means use for a single patient for a limited period of time, such as a single therapy session, or repeated therapy sessions for up to one month, or up to fifteen days, for example, and / or where single use indicates the batteries 308 are not replaceable). In other examples, the device may have rechargeable or replaceable batteries 308 and is adapted for chronic use. A removeable tab 318 may be used to preserve battery capacity prior to use; once the tab 318 is removed, the electrical circuit for powering the device is completed and the device electronics arc enabled. In some examples, an optical light pipe such as an optical fiber may be used to transmit light from LEDs on the circuit board 302 to desired positions, either for use on the indicators, or if used as therapy delivery devices, the optical fiber may extend to at least one of the stimulation elements 312 / 314, which would in turn be optical elements allowing light energy to pass therethrough, for example, lenses. If a light pipe is used, the “stimulation element” may be understood as including each of the LED or other optical source on the cir cuit board, the light pipe or fiber, and any interface element such as a lens that delivers light from the light pipe or fiber to tissue at a target location.

[0131] Figures 8A-8B and 9A-9D provides an illustrative example of status and warning lights. The illustrative device 350 can correspond to any of the devices 10, 11, 12, and / or 13 described herein. Alert indicators (lights typically) can include a contact alert 354A, a successfully completed therapy 354B, and an end of life or catastrophic failure alert or a low battery alert 354C. Other alerts and mechanisms for interaction with the user may be used. A digital screen can be used if desired instead of discrete alert lights.

[0132] The multi-purpose light emitting diode ring 351 can be configured to indicate simulation progress by illuminating, flashing, and / or turning off some or all the progress lights segments which comprise the ring. For instance, the multi-purpose light emitting diode ring 351 can be configured to incrementally indicate progress during the therapeutic segment by flashing or illuminating an individual progress segment to indicate that stimulation is occurring during a corresponding segment of time of the overall duration of the therapeutic stimulation session. For example, the multi-purpose light emitting diode ring 351 can be configured to incrementally indicate progress during the therapeutic segment by turning off the individual progress segment responsive to completion of stimulation for the corresponding segment of time of the overall time of the therapeutic stimulation session and flashing a subsequent individual progress segment to indicate that stimulation is occurring during a subsequent corresponding segment of time of the overall duration of the therapeutic stimulation session, as detailed herein. However, other mechanisms to indicate progress (e.g., changing a color, varying an intensity, etc. of the progress lights can be utilized alternatively or additional to indicate progress during a therapy session.

[0133] The multi-purpose light emitting diode ring 351 can be configured in a in a clocklike circular pattern to indicate stimulation progress and / or can include device status (e.g., in stimulation mode or paused mode) indicators. For example, the progress ring can be formed of various segments representative of distinct portions or segments of therapy. For instance, as illustrated in Figures 8A-8B and 9A-9B the progress ring 351 can have four progress lights 352A, 352B, 352C, 352D (collectively referred to herein as progress lights or progress segment 352). The progress lights 352 can correspond to respective therapy segments (e.g., each segment indicates a 5-minute segment of an overall 20-minute therapy). In such instances, a flashing light of a particular progress segment may indicate that the device is stimulating and also indicates the current 5-min period of the total therapy. A solid light can indicate that a particular segment of therapy (e.g., 5-minute period or segment) of the therapy has been completed. Hence, when therapy is being delivered, the progress indicator lights may light up or turn off in a one at a time manner to indicate progress of a therapy regimen, which may, for example, have a duration in the range of about 1 to about 60 minutes, or about 5 to about 30 minutes, or about 20 minutes. For example, if the device is currently at 6 minutes (has been stimulating for 6 minutes), a first progress light 352A is solid and the second progress light 352B can flash (e.g., periodically blink or turn on / off), as indicated at Figure 8A. Similarly, if the device is currently at 16 minutes into therapy, the first three progress lights 352A, 352B, 352C, can be solid and the 4thprogress light 352D can flash periodically, as illustrated at Figure 8B. A liquid crystal display, touchscreen, or other display may be used instead, if desired.

[0134] As illustrated in Figures 8B and 9A-9B, the device 350 can include one or more alert lights that can be selectively displayed or illuminated. Alert lights such as the alert lights 354A, 354B, and / or 354C (collectively referred to herein as alert lights 354) may include, for example, lights that indicate problems with the device, which may include poor contact with the skin (determined for example using a temperature sensor or an impedance monitor, as desired), expiration of the device, other failure in the device, low battery, etc. A button may be used to initiate or pause the device therapy, as desired. As illustrated in Figures 8A-8B and 9A-9C, the progress ring 351, the therapy segments 352, and / or the alert lights 354 can be located on an exterior surface (e.g., an exterior surface of the first molded piece 20 A, as described herein) of the device 350. Having the progress ring 351, the therapy segments 352, and / or the alert lights 354 be located on the exterior surface of the device can promote aspects herein such as permitting access to and / or permitting the progress ring 351, the therapy segments 352, and / or the alert lights 354 to be readily viewed (e.g., be visible) even when the device is implanted (e.g., in an ear of a patient). However, the quantity, the type, and / or the location of the progress ring 351, the therapy segments 352, and / or the alert lights 354 can be varied.

[0135] Figures 10A-10G show illustrative stimulation device designs. Figure 10A shows an electrode assembly at 360, having a flat contact surface on which a hydrogel or other tissue coupling element 362 is provided. An adhesive, for example, may attach the coupling element 362 to the electrode assembly 360. Figure 10B shows an alternative 370 with a concave contact region 372, which may help hold / contain the tissue coupling element and / or a hydrogel or other gel for aiding in signal transmission across the tissuestimulation element interface. In some instances, an electrode may have a surface that is textured, roughened, scored, or dimpled to increase effective surface area, to thereby lower impedance, in addition serving to receive or retain coupling material, gel, and / or adhesive. Not only electrodes, but any of the described vagus nerve stimulating elements may have textured, roughened, scored or dimpled surfaces, or may comprise an adhesive layer, or may receive a piece of coupling material, gel or adhesive thereon. Figure 10C shows an alternative 380 having a convex contact surface 382.

[0136] Figure 10D highlights two different ways that the electrode 398 contact can be made adjustable. A spring or other resilient member 392 or 396 can be used to maintain pressure against the tissue once the device 390 is placed. The resilient member 392 or 396 may be, for example, a coiled spring, a compressible foam, or any other suitable structure able to be compressed and expand after removal of applied force. A swivel or ball-joint structure shown at 394 can allow the electrode to be laterally angled as desired. The resilient member shown at 392 presses against the end of the swivel or ball-joint structure 394; alternatively, the resilient member 396 may be used instead and is shown extending up to the device enclosure, for example, all the way to the circuit board, on which an electrical connection can be made so that resilient member 396 serves also as the electrical contact to the electrode 398.

[0137] Figure 10E illustrates different approaches to delivery of electrical stimulation. An electrical output requires at least two “poles” for delivery. A bipolar delivery occurs between two relatively closely spaced electrodes. For example, some of the designs shown above include first and second electrodes disposed, respectively, on the conchae caverna and conchae cymba; when electrical signal passes between two such electrodes, a bipolar output is generated. Line A, between electrodes X and Y in Figure 10E can be understood as indicating a bipolar output. On the other hand, a monopolar delivery occurs between a first electrode positioned at a therapy site, and a remote electrode located away from the therapy target. Lines B (between electrode Y and a remote electrode, R) and C (between electrode X and a remote electrode, R) indicate monopolar therapy combinations. Multiple return electrodes can be used, for example to influence voltage fields and spread, focus or steer the outputs, such as shown in Figure 10F where electrode X issues a therapy output with two return electrodes. The return electrode in Figures 10E and 10F may be positioned at any desired distance, as indicated with the use of the broken line gaps. Each of these different types of therapy may be used in various examples. Some examples will omit the remote electrode, R. The opposed poles for bipolar outputs, and / or the pole for monopolar delivery, may be secured for a given device by holding the device in position using opposed sides of the rim of the concha, as shown in Figure IB.

[0138] Other therapy modalities may not require paired neural stimulation elements. For example, as indicated in Figure 10G, some stimulation elements, such as SI, can generate output stimulation that travels in a range of directions. Vibration / acoustic stimulation, as well as magnetic stimulation, may travel in this way, such that SI may be understood as an electro-mechanical, or electro-magnetic transducer. Thermal therapy can be generated as well, and so SI may instead be a thermal element such as a resistor that converts electrical current to heat. Some optical outputs provide collimated light outputs, such as light emitting diodes and / or vertical cavity surface emitting lasers, as illustrated at S2. A dispersing lens may be included as shown for S3, to provide a spread the output light energy; alternatively, a less directional light source can be used, as desired. Figure 11 is a block diagram for illustrative circuitry. The illustrative circuitry may be described as operational circuitry for the device, and would be contained in the housing as shown in any of the preceding examples. The device includes a controller 400. The controller 400 may take many forms, including, for example, a microcontroller or microprocessor, coupled to a memory 402 storing readable instructions for performing methods as described herein, as well as providing configuration of the controller for the various examples that follow. The controller 400 may include one more applicationspecific integrated circuits (ASIC) to provide additional or specialized functionality, such as, without limitation, a signal processing ASIC that can filter received signals from a sensor 403 such as those described herein using digital filtering techniques. Logic circuitry, state machines, and discrete or integrated circuit components may be included as well. A controller 400 may take the form of a state machine, if desired. The skilled person will recognize many different hardware implementations are available for a controller. Likewise, the memory 402 can take any suitable form, including Flash memory, combinations of multiple memory types, etc.

[0139] The operational circuitry also includes a power supply block 404, coupled to a battery 406. The power supply block may include voltage step-up or step-down circuitry, or may include appropriate regulators, converters and the like, as well as smoothing circuitry as needed / desired to obtain power from a battery 406 and provide power at specified voltage / current for use in the controller 400 as well as the output circuitry shown at 410. One, two, three, four or more battery cells may form a battery 406; commercial off- the shelf button-type batteries may be used, or specialized versions may be developed and used. For example, three or four lithium-chemistry button batteries may provide 9 or 12 volts of power supply, allowing maximum currents in the device to stay relatively small (reducing heat), while generating sufficient headroom to provide desired current or voltage levels for therapy. Batteries may be replaceable, if desired. Rechargeable batteries could be used, whether removeable and rechargeable or by providing a recharging circuit as indicated at 408, in the device, where power can be transferred to a recharging circuit by use of an electrical port on the device, or by wireless transmission (inductive, RF, ultrasonic, etc.) to a transducer on or inside the device. An example may use an inductive loop coupled to a rectification circuit that in turn delivers current / power to the battery 406 for recharging, for example. A recharging case or cord, for example, can be used to enable recharging of the device or devices (for example, if provided in pairs, rather than as stimulation for a single ear-). Some examples may include electrical contacts on the device for recharging in a recharging case / housing, if desired.

[0140] The power supply 404 may further include a dedicated voltage converter to provide, for example, a source for a current controlled output circuitry. In an example, an inductive or capacitive step-up circuit is used to store a 60- volt amplitude on one or more capacitors to provide headroom for a current controller output circuit using, for example, one or more current mirrors to control the output current. Suitable amplifier-based circuits may be used, instead, or any other desired circuit can be used. While inductive step-up circuitry can be used, capacitive converter designs may provide better MRI-compatibility and tend to be smaller and introduce less weight.

[0141] The output circuitry 410 may include a set of switches, such as an H-Bridge circuitry design, configured to provide alternating signal outputs. Square wave outputs may be used, and may be current controlled or voltage controlled, as desired. Non-square waves can be used as well, such as exponentially decaying, sinusoidal (in which case a resonant circuit can be included), triangle, ramped, etc. The output circuitry may be coupled to electrodes 430 for use in delivering electrical stimulation. Alternatively, or in addition, one or more transducers 432 for use in issuing optical, mechanical, or magnetic stimulation outputs can be coupled to the output circuitry 410. The power supply 404 is configured to provide voltage step-up (such as a voltage multiplier using inducive or capacitive elements), allowing the output circuitry to shape and control the power signals issued to the electrodes 430 or transducer 432. The transducer 432 may also receive control signals from the controller 400 to manage, for example, output frequency of the transducer, depending on design.

[0142] A set of monitoring circuity 412 can be included to monitor the operations of the output circuitry. For example, sample / hold circuits can be used to determine the voltage while issuing current controlled outputs, allowing the impedance that output signals encounter to be tracked. If a voltage-controlled output is used, current monitors can be used to determine impedance as well. If an exponentially decaying output is provided, the slope of voltage on a capacitor used to output the signal may be determined by monitoring voltage change over time, to give a measure of impedance as well. High impedance, over a predetermined threshold for example (which may vary with device placement, and / or inclusion or exclusion of hydrogel or other tissue interface enhancers) may be used to determine appropriate device placement and / or tissue contact. Low impedance, on the other hand, can indicate shorting between the output electrodes that could present a burning hazard to the patient, depending on other system controls.

[0143] The monitoring circuitry 412 can include, for example, a temperature sensor (such as a thermistor, resistance temperature detectors, thermocouples, and / or integrated circuit sensors) to monitor temperature at the tissue interface. If sensed temperature is below a low temperature threshold (for example, 25C), the monitoring circuitry 412 may stop therapy due to sensed poor tissue contact, and if the sensed temperature is above another threshold (for example, 40C), the monitoring circuitry 412 may stop therapy (or reduce therapy amplitude / intensity or change other therapy parameters) due to potential burn hazard due to, for example, device error, malpositioning, or amplitude settings that are too high. Other sensors may be included to monitor therapy output parameters, patient response, or patient characteristics to ensure therapy efficacy and / or prevent patient harm.

[0144] The monitoring circuitry 412 may also monitor battery status, including, for example, a current sensor or coulomb counter if desired to track actual battery use, or a voltage sensor to determine open, lightly loaded, or loaded output voltage of the battery 406 or individual cells therein. Battery usage may instead be tracked, for purpose of determining battery end of life / status, by the controller 400 using timers and therapy counting, as desired. Monitoring circuitry 412 may observe characteristics of the output circuitry to, for example, ensure that the power supply 404 is providing sufficient voltage step-up to allow therapy to be delivered as desired.

[0145] The memory 402 may store controller-readable instructions for operating the device in any suitable form, and can also store operating data, including time spent in pause, on / off or other operational data. Operational data may include temperature or impedance data, if desired, or any other sensed parameters or signal.

[0146] The controller is also coupled to what may be termed input-output devices, including any buttons 420 on the device, and / or the lights or speakers 422 described above. A screen or touchscreen may be used instead or as well as those items shown. Some systems may optionally include an RF circuit block 424, including, for example and without limitation, Bluetooth, WiFi, and / or any wireless communications circuitry (antenna, driver, crystal / resonator, etc.) for performing wireless communication with a separate device. For example, a smartphone operating an application may communicate via Bluetooth with the device to control any characteristic of therapy (duration, on / off, repetition rate, amplitude, pulse width, type, etc.) and / or to obtain therapy data (impedance, usage, etc.).

[0147] General purpose devices may communicate with the therapy system if desired, using for example an application operating on a smartphone, tablet, or computer. A “programmer” maybe used instead of a general-purpose device, where a programmer is a dedicated device configured for use with the stimulation system. In some examples, to simplify use in an emergency context or even in the ICU, a dongle may be provided that carries programming circuitry (communications and stored software instructions) for communicating with an programming a therapy device, wherein one end of the dongle can be plugged into, for example, a universal serial bus port (or any other port) on a tablet, smartphone or computer; once plugged, the software on the dongle can launch an application on the device for programming the therapy system, so that the physician / nurse or other medical user does not need to download any software to control the system.

[0148] Communication may be used to modify therapy settings, upload new software to the device, and / or to download therapy or other usage data. Device status, such as battery capacity, may be communicated. Communication may also be used to turn the device on or off, if desired, rather than relying on a button or other actuatable component on the device and / or device housing.

[0149] Figures 12A-12B show a block process flow diagram of an illustrative method. A relatively comprehensive method is shown; some other or alternative examples may omit one or more blocks / steps, or may replace the illustrative steps shown with other steps. For instance, the methods herein can additional include adjusting the actuating the adjustment mechanisms to vary and adjustable distance between the first extending structure and the second extending structure until the second extending structure abuts the helix, the antihelix, the inferior crus, or any combination thereof, as described herein. For example, the methods herein can include adjusting the adjustable distance prior to, during, and / or subsequent to placing the devices (e.g., an anchor arm of the devices) in the auditory canal. As mentioned, the adjustment mechanisms herein can be actuated with one or more digits on an individual hand of a user. Hence, the adjustment mechanisms herein can permit adjustment with one hand (an individual) hand of a user. The adjustment can be performed by way of rotation or translation of the adjustment mechanism e.g., relative to the housing 20, unlike some device that require pinching or the use of two hands to adjust aspects of a device.

[0150] At block 500, a user or a person helping the user (a nurse, physician, caretaker, etc.) presses the start button on the device. The device controller then uses stored instructions to execute a method as shown and described herein. First, the device controller checks device expiration, as indicated at 502. This may include determining battery status at 504, such as by comparing a measured battery voltage (open circuit or lightly loaded in some examples) to a battery voltage threshold. If the battery voltage is below the threshold, this indicates a low battery condition, and the controller will then activate an expired device indicated at block 510. If the expired device indicator is activated at 510, the method stops.

[0151] Checking device expiration at 502 also includes, in some examples, observing the status of a pause or life timer. A pause timer may indicate an amount of time since a therapy was initiated. A life timer may indicate an amount of time since the device was activated. One, the other, or both timers can be used in any given implementation. If either timer has exceeded a predetermined threshold, the controller determines the device has expired, and the controller will then activate an expired device indicated at block 510. Once the expired device indicator is activated at 510, the method stops.

[0152] Checking device expiration at 502 also includes, in some examples, determining whether a therapy regimen has been completed, as indicated at 508. Once the predetermined therapy regimen for the device has been completed, the controller determines the device is expired, and the controller will then activate an expired device indicated at block 510. Once the expired device indicator is activated at 510, the method stops. For example, a therapy regimen can be predetermined to provide a 20-minute duration therapy, once daily, for up to two weeks. For purposes of block 502, if more than two weeks, plus one to seven days to allow for therapy pauses, has occurred since device activation, this may be treated as exceeding the life timer, or if all the therapy steps of the regimen have been performed, this may be treated as completing the therapy, or if a pause of more than a set duration (72 hours, for example) has occurred, this can be treated as exceeding the pause timer. In some examples, a dual pause timer threshold is present. For example, if a first preset period (one to four hours, for example) is exceeded since a therapy pause, a therapy dose (for example a 20 minute session may be the therapy “dose”), the therapy dose can be re-started; if a second preset period (48 to 96 hours, for example) is exceeded, this can be treated as if the therapy regimen has been interrupted or stopped, and the device is treated by the controller as expired.

[0153] If the method passes block 502 without device expiration, the controller determines whether the therapy timer has been started at block 512. If the therapy timer has not been started, the method goes to block 514 and stalls the therapy timer. At block 514, the therapy pause timer may be initialized or reset, to ensure that it starts from zero if the therapy timer is also starting from zero. The method then proceeds to Figure 12B.

[0154] In Figure 12B, an impedance check is performed at 520. The impedance check may be performed by outputting a therapeutic or non-therapeutic pulse / waveform to obtain an impedance measurement and check the contact between the electrodes and the patient’s skin. For example, a non-therapeutic pulse can have a shorter pulse width, or a shorter amplitude, than a therapeutic pulse width so that the impedance can be checked without outputting a relatively higher energy therapy pulse. As noted, a therapy pulse can be used instead. The impedance, once obtained, is compared to at least a high impedance threshold, which, if exceeded, indicates poor or no contact with the patient tissue. Impedance may be compared to a low impedance threshold as well, if desired, to ensure there is no shorting of the output electrodes, in which case therapy may be ineffective if it does not reach the target tissue. If the impedance is out of range (too high, or too low, for example) the controller activates the bad contact indicator as indicated at 522. Therapy is paused as indicated at 524, and the pause timer starts at 526. The therapy timer is paused at 528, and the system awaits actuation of the stall button. Here, the end state is that therapy is paused with the bad contact indicator active, until the user adjusts device position and depresses the start button, which will return the method to block 500.

[0155] While impedance can be used for systems having electrodes for issuing electrical therapy, other system placement checks can be performed. In an example, a temperature sensor is checked to confirm an appropriate sensed temperature range (for example, 25C to 40C). For example, a temperature sensor can be positioned on the anchor arm, or adjacent to a stimulation element, such as a transducer. When the device is positioned against patient tissue, the sensed temperature should be near the temperature of tissue, typically in the range of 36C to 37C; the broader range of 25C to 40C may be used to allow for the device to activate promptly after positioning on tissue, in which case the temperature sensor may lag for seconds or even minutes as the surfaces and materials of the device warm up to body temperature in response to body contact. Contact or positioning may be determined using other approaches, such as having a pair of non-therapy, sensing-only electrodes positioned to sense tissue contact. If an optical output is used, an optical sensor may be positioned to observe reflected light from patient tissue, thereby confirming contact if the reflected light matches an expected bandwidth and / or intensity, for example. These examples are intended to be illustrative and not limiting.

[0156] If the impedance check is passed at 520, the method determines whether the pause button has been depressed at block 540. If so, the method includes activating the paused indicator at 524, and then follows the rest of the steps at 526, 528 and 530. Here, however, the end state is that the therapy is paused with only the paused indicator active, until the user depresses the start button, which will return the method to block 500.

[0157] At block 550, having passed the checks at 520 and 540, therapy is activated if not already active, and the device issues at least one output pulse. As this occurs, the therapy progress indicator is activated. After at least one output pulse is generated, the method proceeds to block 552, to determine whether therapy is completed. Therapy complete may be determined using a time since therapy started, a total time of therapy active, or a quantity of pulses delivered, or some other measure as desired. If therapy is not completed at block 552, the method reverts to block 520 and re-runs the impedance check; on such a reversion, in some examples, impedance determined during therapy pulse outputs is used, rather than any test pulses as described previously, so that therapy does not have to be interrupted. Alternatively, the method may return to block 520 at periodic intervals (every 1 to 15 seconds, for example) when therapy can be interrupted for a test pulse to determine impedance. As noted, non-impedance-based therapy monitoring or tissue contact monitoring can be used instead. If therapy is complete at block 522, the method stops the therapy outputs and ceases all clock / timcr activity at 554, and sets a therapy complete indicator at 556. A stored bit may be set as well to indicate therapy complete, so that actuation of the start button at any future time will result in a device expiration in the step at 502 in Figure 12 A.

[0158] For a recurring therapy method, there may be a shell outside of that shown in which a regimen of therapy is provided by executing a method as shown in Figures 12A-12B daily. The checks performed at block 502 may include a regimen complete check, as desired.

[0159] Returning to Figure 12A, in some examples, a replaceable battery or rechargeable battery is used; if so, the battery status 504, if failed, may yield a battery alert indicator being activated, rather than expired device. Additional monitors and checks may be included. A watchdog timer, as well as other failure monitors, can be used to set a failure or device expired bit in memory, causing the device to be marked as expired.

[0160] Throughout both Figures 12A and 12B, compliance 501 can be monitored in several ways. The device itself may carry, for example and without limitation, a barcode or quick response (QR) code readable or scannable by a mobile device, such as a smartphone, allowing device registration. Device registration can be used to activate the device remotely, to provide a code allowing device activation to a mobile device, and / or to track device activation and / or usage by the manufacturer or a health care provider. For example, in the intensive care unit (ICU) or other medical care context, a nurse, technician, physician or other person may scan a QR code when a device is applied to a patient. A device readable item (QR code for example) is illustrated on a stimulation device in Figure 13, at 602, for example. Any suitable positioning, including on external packaging of the stimulation device or on the device itself, can be used as desired. The QR code may be positioned on a removable tab 318 as shown in Figure 7 so that code scanning only takes place after the device has been activated, preventing erroneous or early activation.

[0161] Some examples may make use of a device logging function internal to the device electronics. For example, a log of usage and / or measured data may indicate (including with time stamps) when and how the device has been used by recording voltages and / or current delivered. Such a log may be stored in suitable manner in device memory. Any measurements the device takes including, for example, measured temperature, impedance and / or other data may be stored in a log file as well. Log files may be accessed and / or retrieved from a device by the use of wired transfer (such as via a plug-in device to a charger as in Figure 13, to a smartphone or computer, for example) and / or wireless transfer such as by cellular, Bluetooth, WiFi, optical or other communications modality. All or selected portions of logged data may be used to track compliance and / or to observe device operations for device quality or any other desired purposes.

[0162] The process flow in Figure 12B may be adjusted to use an interrupt, rather than a recurring check, on the user depressing or actuating the pause / start button. Thus block 540 may be used to interrupt any of the other process steps in response to user action, as desired. For example, block 550 may be a therapy on block, operable for a period of one to thirty seconds, during which actuation of the pause button would work as an interrupt. Periodically, then, the system would perform the impedance check. In other examples, the impedance check is performed after each delivered therapy pulse, if desired.

[0163] The device and system may be configured for a variety of use cases. For example, the wearable vagus nerve stimulation can be used in conjunction with pharmacological interventions to treat sepsis in ICU patients. By targeting inflammation including use of vagus nerve stimulation, the system can help modulate the immune response and potentially improve outcomes in patients with severe sepsis.

[0164] In another example, in patients with acute respiratory distress syndrome (ARDS) in the hospital setting, wearable vagus nerve stimulation can be utilized alongside mechanical ventilation and anti-inflammatory medications to reduce lung inflammation and improve oxygenation. This combined approach may enhance the overall management of ARDS and potentially speed up the recovery process.

[0165] In another example, for patients with severe pneumonia requiring intensive care, wearable vagus nerve stimulation can complement antibiotic therapy and respiratory support by targeting systemic inflammation. By regulating the inflammatory response, this adjunctive therapy may help in reducing the severity of pneumonia and preventing complications in critically ill patients.

[0166] In another example, in the management of inflammatory bowel disease (IBD) exacerbations in hospitalized patients, wearable vagus nerve stimulation can be used along with corticosteroids and immunosuppressants to control intestinal inflammation. This combined treatment approach may offer a novel strategy to alleviate symptoms and promote mucosal healing in patients with severe IBD flares.

[0167] In another example, wearable vagus nerve stimulation can be combined with pain management techniques in post-operative ICU patients to mitigate surgical inflammation and improve recovery outcomes. By targeting the inflammatory cascade, this adjunct therapy may aid in reducing post-operative complications and enhancing the overall healing process in critically ill surgical patients. In addition, again for the post-surgery context, wearable vagus nerve stimulation can be utilized post-operatively to enhance bowel motility by delivering targeted electrical impulses to the vagus nerve, promoting gastrointestinal motility and reducing the risk of post-operative ileus.

[0168] In another example, a wearable vagus nerve stimulation device can be used in conjunction with remote monitoring systems to continuously track the patient's heart rate, blood pressure, and other vital signs. By integrating real-time data from the device with the digital monitoring platform, healthcare providers can quickly identify any signs of worsening heart failure and intervene promptly to prevent readmission.

[0169] In an example, wearable vagus nerve stimulation can be used in combination with traditional pharmacological treatments for Congestive Heart Failure (CHF) to reduce readmission rates. By incorporating vagus nerve stimulation into the patient's treatment plan, the device can potentially improve heart function, reduce inflammation, and enhance autonomic balance, leading to better overall outcomes and decreased risk of hospital readmission.

[0170] Figures 13-14 show stimulation devices with chargers. For a patient to use a device in a chronic sense, the power supply must be either replaceable (such as with replaceable batteries) or replenishable. A rechargeable stimulation device may be useful in any context. In Figure 13, a stimulation device 600, carrying a QR code marker 602, is shown connected to a charger 610 using a wire 612. The connection may use standard connectors, such as uniform serial bus (USB) connectors, micro-USB, etc., or may be a special purpose connector 612 to prevent unauthorized use or modification of the stimulation device 600, if desired. The charger 610 may be battery powered or may use wall power, as desired. The stimulation device 600 may remain positioned in the ear of a patient during charging, or may be removed. Another example is shown at Figure 14. Here the stimulation device 620 is received in a charger 630, having a depression or cradle 632 for receiving the stimulation device 620. Electrical connectors can be provided in the cradle 632, positioned to align with electrical connections on the outside of the stimulation device 620 (such as any of the electrodes shown above, or using connectors adapted specifically for charging). Other modes of power transmission can be used, including inductive, RF, optical, etc., as desired.

[0171] In each of Figures 13-14, data transmission can be performed while charging takes place. For example, logs of therapy utilization and / or device status may be transferred to the charger 610, 630, which may in turn transmit any received data to a central database by any suitable communications mode, such as over the internet, cellular, etc. Likewise, therapy firmware in the stimulation devices 600, 620 may be updated, or settings modified, as desired. The chargers 610, 630 may be connectable to additional devices, such as a smartphone operating a dedicated application for the purposes of software updating, logfile reading / review, and / or parameter modification, if desired.

[0172] Figure 15 illustrates various electrode configurations that can be used, as desired. Electrode structures are shown at 32, 44, and 46, corresponding to the electrodes that can be used in systems and devices herein. Various examples of system electrode configurations may be achieved. Electrode structure 44 would be positioned on the anchor arm, and is omitted in some examples. The electrode structure 32 may be a single electrode 32a, or may include more than one electrode, such as electrodes 32b, 32c (more than two may be used, if desired). Likewise, the electrode structure 46 may be a single electrode 46a, or may include more than one electrode, such as electrodes 46b, 46c (more than two may be used, if desired). When present, the electrode structure 44 may be a single electrode 44a, or may include more than one electrode, such as electrodes 44b, 44c (more than two may be used, if desired). Various combinations are contemplated:

[0173] Electrode structure 32 may include two electrodes 32b, 32c, with therapy delivered between those two electrodes 32b, 32c only, directing therapy to the conchae cymba. Other electrodes may be omitted, or may be present but inactive, or may delivered a separate waveform. Electrode structure 46 may include two electrodes 46b, 46c, with therapy delivered between those two electrodes 46b, 46c only, directing therapy to the conchae caverna. Other electrodes may be omitted, or may be present but inactive, or may delivered a separate waveform.

[0174] Each of electrodes 32b, 32c, 46b, 46c may be included in some examples, and therapy may be delivered in sequential anode / cathode pairs, for example as shown here:

[0175] Anode Cathode

[0176] 32b 46b

[0177] 32c 46b

[0178] 32b 46c

[0179] 32c 46c

[0180] Therapy may start at the top row and proceed to each successive row. After one round of such therapy, the sequence may be repeated with opposite polarity, for example. Other combinations and / or sequences can be used. As the skilled person will understand, this approach may require multiple sources in the electronics of the device, providing multiple, independent signals to control individual electrodes. Some other examples may have one electrical source and a plurality of switches to direct therapy signals as desired. Some examples may have multiple electrical signal sources and a set of switches arranged to multi-plex the output signals as desired.

[0181] With a larger number of electrodes, additional flexibility is enabled allowing the electrical field applied to the underlying tissue to be shaped or tailored as desired. Groupings of electrodes may be electrically connected to form larger or smaller effective stimulation areas. Individual or grouped electrodes may be independently controlled to provide varying levels of stimulation so as to shape activation fields to location or depth to preferentially activate underlying tissue, or to avoid or suppress activation of underlying tissue. In some examples, stimulation intensity can be adjusted to account for electrode position / proximity and / or side. For example, larger currents can be delivered with ganged- together electrodes with less concern regarding patient comfort. Also, varying frequencies of stimulation between electrodes may be used to activate, inhibit, or avoid stimulation of underlying tissue by creating interacting activation fields, like beat frequencies, or inferential therapy. The circuitry in the stimulation device may include multiple outputs that allow for independent control over each electrode and / or plural electrode pairs, if desired, to allow multiple waveforms to be delivered at the same time. For example, a sinusoidal first stimulation signal issued between electrode 32b and electrode 46b at 40 Hz could be output at the same time as a second stimulation signal generated at 30 Hz using electrode 32c and electrode 46c, resulting in a 10 Hz beat frequency arising within the patient tissue. Other “beat” related approaches or interferential signals may be used instead or in addition to these examples.

[0182] Figures 16-18 illustrate further structures. In Figure 16, a wearable vagus nerve modulation device 700 includes an extending structure 702 which carries an anchor arm 704, having an extending anchor arm 706 moveably mounted therein as indicated by the arrow. Ridges are provided as shown at 708 for holding a removable tip thereon, to anchor in the auditory canal of the user’ s ear. An electrode or transducer (optical, sonic, magnetic, thermal, etc.) is provided as stimulating element 710. When placed, the stimulating element 710 may be placed against the user’s skin in the conchae caverna. A plurality of tips 712, in a range of sizes if desired, are provided with the device. Tips 712 may come in various shapes or sizes to allow different users to select a best fit. Tips 712 may be replaceable, as the position in the auditory canal may lead to wax build up, for example, making occasional or periodic replacement useful.

[0183] The extending structure 702 also carries a stimulator extension 722 which can be extended or retracted relative to a receiver 720, such as by including a spring-loaded structure, as indicated by the arrow. The stimulator extension 722 forms an angle 721 relative to the axis of the extending structure 702, the angle being, illustratively, in the range of about 30 to about 60 degrees; in an example, the angle 721 is about 45 degrees. A stimulating element 724 is positioned on a carrier 726, which may be a generally hollow piece that can slide over the stimulator extension 722, as indicated by the arrow. Positioning may again be spring loaded, if desired. This design has a single extending structure 702 relative to the main body of the device 700.

[0184] The extending structure 702 may be rotatable (at least partly) if desired, allowing the main body to directed, vertically, horizonal, or at an angle therebetween when placed on the patient. For example, if a patient is in a recumbent position in the ICU, as opposed to being ambulatory outside of the ICU, different positioning may be desired, so the rotation of the extending structure may be used to adjust for comfort and secure positioning. In some examples, the receiver 720 is rotatable relative to the anchor arm 704, for example, allowing different angles to be defined therebetween, if desired.

[0185] Figure 17 shows the orientation of actuators or electrodes of Figure 16. It may be noted that Figure 16 illustrates the location of the anchor arm 706 relative to the stimulator extension 722 at an angle so that the stimulator extension 722 can be observed in one drawing. Figure 17 illustrates these angles with a bit more clarity. The stimulating element 710, along with the stimulating element 724 and the anchor arm at tip 712 form an angle as shown at 711. The positions of stimulating element 724 and tip 712 are adjustable as illustrated with arcs 713 and 725, so that the angle 711 can be varied in the range of about 60 degrees to about 135 degrees, or more or less. The angle 711 may be, for example, about 90 degrees, if desired. The angle 711 can be adjustable if desired. In some examples, angle 711 is instead a fixed angle.

[0186] In some examples, textured, ridged, disk, or bulbous shapes (or combinations thereof) may be used to aid in securing the device in place by including such shapes on the anchor and / or an extending structure. For example, the three elements 710, 712, and 724 shown in Figure 17 each represent touch points to tissue of a patient. Any one, two or all three of these touch points can include a shape (such as bulbous or disk-shape), ridges, texture or roughening that discourages or prevents passage along or past tissue or a tissue ridge or layer, such as the helix, antihelix, helical crus, intertragal notch, tragus, and / or anti-tragus. Such shape, ridges, texture or roughening may be applied on all sides of any of the three touch points, or only along an outer edge or tissue-contacting side thereof, as desired. By outer edge, the intent is to indicate the portion of any anchor or extending structure that would press against tissue to hold the device in a desired position.

[0187] Figure 18 shows another example. Here, the wearable vagus nerve modulation device has a main body 750 and an extending structure 752. The extending structure 750 terminates with electrodes or transducers (optical, sonic, magnetic, thermal, etc.) provided as stimulating elements 752, 754, which may be positioned over the conchae caverna, as desired. An anchor extension 760 extends off at an angle from the extending structure 750, and carries an anchor arm 762 adapted to receive an anchor 764 for placement in the auditory canal. The anchor 764 can be replaceable and / or may come in various sizes and shapes, and further may include one or more electrodes or transducers (optical, sonic, magnetic, thermal, etc.) thereon, shown as stimulating element 766.

[0188] A stimulator extension 770 is also provided from the extending structure 752, extending laterally therefrom and having a carrier 772 for one or more stimulating elements 774, 776, which can be electrodes or transducers (optical, sonic, magnetic, thermal, etc.) as desired. The stimulator extension 770 is at more or less a right angle relative to the extending structure 752 in the illustrative example, as contrasted with the use of an angle in the range of about 30 to about 60 degrees for the stimulator extension 722 of Figure 16. The use of a sharper angle may make positioning easier relative to anatomical structures of the ear, such as avoiding interaction with the crus of helix.

[0189] The anchor arm 762 may be extendable / retractable, as indicated by the arrow. Likewise, the carrier 772 may extend or retract over the stimulator extension 770, as indicated by the arrow. Optionally, in some examples, the stimulator extension 770 and / or the anchor extension 760 may be rotatable relative to the extending structure 752, allowing repositioning and adjustment if desired. Still further, the extending structure 752 may itself be rotatable, in some examples, relative to the main body 750. Rotation of the extensions and / or structures relative to one another can be omitted in other examples.

[0190] Figures 19-20 show illustrative gel pad designs. In Figure 19, the gel pads are provided on the device for conducting electric (or other) signals to the skin. For example, a metal electrode placed on dry skin can encounter a larger impedance, thus attenuating therapy signals, than an electrode placed over a conductive liquid or gel on the skin. In the example of Figure 19, a first extending structure 800 may include two electrodes, each of which may be recessed relative to a surface 802. Gel pads 804, 806 reside on the electrodes in each associated recess and include or are made of a conductive and biocompatible material such as, but not limited to, a hydrogel. The recess helps to hold the gel pads in place, and prevents, for example, the gel pads 804, 806 migrating off of the electrodes and / or coming into contact with one another, either of which could reduce therapy efficacy by increasing tissue interface losses with added impedance (in the case of gel pad migration), or by shunting current (in the case the gel pads come into contact or close proximity with one another). A second extending structure 810 uses a similar recessed electrode structure and gel pads 812, 814. The gel pads 804, 806, 812, 814 may be a custom consumable for the system, and may be replaced with each use (in the event of home use) or may be left in place for a single-use device over the course of a therapy session or regimen lasting hours to weeks. Use of the recessed electrode is optional.

[0191] Figure 20 shows an alternative example. Here, the extending structure 820 carries a pad 822 that surrounds the stimulation element 824. In this case the pad 822 is used to help stick to the skin of the patient, and may have an adhesive backing for placement against the extending structure 820, surrounding the electrode 824 as shown in the inset side- section view. The pad 822 may be a custom consumable for the system, and may be replaced with each use (in the event of home use) or may be left in place for a single-use device over the course of a therapy session or regimen lasting hours to weeks. If the device uses an electrode as the stimulation element 824, the pad 822 may be a non-conductive substance, if desired, so that the electrical therapy output says focused at the location of the stimulation element 824. The pad may, for example, be a substrate of any suitable material, including natural materials (wool, cotton, silk, etc.) having an adhesive on each side, or a synthetic material, such as but not limited to polymers, again with an adhesive on each side thereof. Pad 822 may comprise a gel or other semi-liquid material.

[0192] Each of the non-limiting examples herein can stand on its own, or can be combined in various permutations or combinations with one or more of the other examples.

[0193] The above detailed description includes references to the accompanying drawings, which form a part of the detailed description. The drawings show, by way of illustration, specific embodiments. These embodiments are also referred to herein as “examples.” Such examples can include elements in addition to those shown or described. However, the present inventors also contemplate examples in which only those elements shown or described are provided. Moreover, the present inventors also contemplate examples using any combination or permutation of those elements shown or described (or one or more aspects thereof), either with respect to a particular example (or one or more aspects thereof), or with respect to other examples (or one or more aspects thereof) shown or described herein. In the event of inconsistent usages between this document and any documents so incorporated by reference, the usage in this document controls. In this document, the terms “a” or “an” are used, as is common in patent documents, to include one or more than one, independent of any other instances or usages of “at least one” or “one or more.” Moreover, in the claims, the terms “first,” “second,” and “third,” etc. arc used merely as labels, and are not intended to impose numerical requirements on their objects. Method examples described herein can be machine or computer-implemented at least in part. Some examples can include a computer-readable medium or machine- readable medium encoded with instructions operable to configure an electronic device to perform methods as described above. An implementation of such methods can include code, such as microcode, assembly language code, a higher-level language code, or the like. Such code can include computer readable instructions for performing various methods. The code may form portions of computer program products. Further, in an example, the code can be tangibly stored on one or more volatile, non-transitory, or nonvolatile tangible computer-readable media, such as during execution or at other times. Examples of these tangible computer-readable media can include, but are not limited to, hard disks, removable magnetic or optical disks, magnetic cassettes, memory cards or sticks, random access memories (RAMs), read only memories (ROMs), and the like. The above description is intended to be illustrative, and not restrictive. For example, the abovedescribed examples (or one or more aspects thereof) may be used in combination with each other. Other embodiments can be used, such as by one of ordinary skill in the art upon reviewing the above description. The Abstract is provided to comply with 37 C.F.R. §1 .72(b), to allow the reader to quickly ascertain the nature of the technical disclosure. It is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. Also, in the above Detailed Description, various features may be grouped together to streamline the disclosure. This should not be interpreted as intending that an unclaimed disclosed feature is essential to any claim. Rather, innovative subject matter may lie in less than all features of a particular disclosed embodiment. Thus, the following claims are hereby incorporated into the Detailed Description as examples or embodiments, with each claim standing on its own as a separate embodiment, and it is contemplated that such embodiments can be combined with each other in various combinations or permutations. The scope of the protection should be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.

Claims

What is claimed is:

1. A wearable device adapted for placement relative to an ear of a patient, comprising: a housing containing electronics and a power source; a first extending structure having a first end at the housing and a second end apart from the housing, the first extending structure having a first length, the second end configured for contacting the posterior edge of the crus of helix and / or antitragus; a first anchor arm extending laterally from the first extending structure and carrying an anchor element thereon, the anchor element configured for positioning beneath a tragus of the ear of the patient to thereby support positioning of the wearable device; a second extending structure comprising a first end at the housing and a second end apart from the housing, wherein the first and second extending structures are separated by an adjustable distance; a carriage coupled to the first end of the second extending structure and being at least partially disposed within the housing, wherein the carriage is configured to move longitudinally along a length of the housing; and an adjustment mechanism coupled to the carriage, wherein the adjustment mechanism is configured to impart a force to cause longitudinal movement of the carriage to adjust the adjustable distance.

2. The wearable device of claim 1, wherein the adjustment mechanism is configured to press the first extending structure to apply force to opposed sides of the rim of the concha, to thereby hold the wearable device in a desired position in the ear of the patient.

3. The wearable device of claim 2, wherein the opposed sides comprise one of an antihelix or an inferior crus of the antihelix of the patient, and any one of a tragus, an antitragus, or a posterior edge of the antihelix of the patient.

4. The wearable device of any of claims 1-3, wherein the adjustment mechanism is configured to be actuated by contact from one or more digits on an individual hand of a person to a surface or edge of the housing.

5. The wearable device of claim 1, wherein the adjustment mechanism is integral with the carriage.

6. The wearable device of claim 5, wherein the adjustment mechanism is located on a first end of the carriage.

7. The wearable device of claim 5, wherein adjustment mechanism comprises a protrusion extending from the carriage.

8. The wearable device of claim 1, wherein the adjustment mechanism comprises a separate component that is coupled to the carriage.

9. The wearable device of claim 8, wherein the adjustment mechanism further comprises a rotatable adjustment mechanism including an annulus, wherein the rotatable adjustment mechanism is configured to rotate about the annulus relative to the carriage, the housing, or both the carriage and the housing.

10. The wearable device of claim 9, wherein: the housing includes a slot extending through the first end of the housing; the rotatable adjustment mechanism comprises a lever extending through the slot to a position outside of the housing, and teeth disposed along at least a portion of a periphery of the rotatable adjustment mechanism that is located in the housing; and the carriage includes corresponding teeth that are configured to interface with the teeth to impart the longitudinal movement of the carriage responsive to rotation of the lever.

11. The wearable device of claim 10, wherein: the carriage includes an elongated longitudinal slot extending along a portion of the length of the carriage; and the housing includes a peg configured to extend into the elongated longitudinal slot.

12. The wearable device of claim 9, wherein: the housing includes a slot extending through the first end of the housing; and the rotatable adjustment mechanism comprises a wheel with a toothed surface along at least a portion of a periphery of the rotatable adjustment mechanism and a curvilinear slot extending within a portion of the wheel.

13. The wearable device of any of claims 1-12, wherein the second extending structure comprises a wing extending laterally therefrom, configured to contact and / or fit under one of the helix or the cymba of the patient’s ear.

14. The wearable device of claim 13, wherein the wing is rotatable relative to the second extending structure.

15. The wearable device of any of claims 1-14, wherein a first vagus nerve stimulating element is on the first extending structure, and a second vagus nerve stimulating element is on the second extending structure, the first vagus nerve stimulating element and the second vagus nerve stimulating element each being coupled to the electronics.

16. The wearable device of claim 15, wherein the first vagus nerve stimulating element and the second vagus nerve stimulating element are each electrodes.

17. The wearable device of any of claims 1-16, wherein the adjustment mechanism is spring loaded to expand, and actuating the adjustment mechanism further comprises compression against the expansion such that when released the spring expands to securely anchor the device in the rim of the concha, optionally between the inferior crus of the antihelix or the antihelix and lower concha.

18. The wearable device of any of claims 1-17, wherein at least one of the first extending structure or the second extending structure is compressible and / or has a variable or adjustable length.

19. The wearable device of any of claims 1- 18, wherein the first extending structure is located on a first side of the housing, and a second side of the housing opposite the first side comprises at least one control button or switch for controlling activity of the electronics and at least one light connected to the electronics for indicating one or more of a device status and a stimulation progress during a therapeutic stimulation session.

20. The wearable device of any of claims 1-19, wherein the carriage, the housing, or both the carriage and the housing include detents configured to predispose the carriage to one or more longitudinal positions along a length of travel of the carriage.

21. A wearable vagus nerve modulation device adapted for placement relative to an ear of a patient, comprising: a housing containing electronics and a power source, the housing having a housing length and a housing width; a first extending structure having a first end at the housing and a second end apart from the housing, the first extending structure having a first length, the second end configured for contacting the posterior edge of the crus of helix and / or antitragus and carrying at least a first vagus nerve stimulation element; a first anchor arm extending laterally from the first extending structure and carrying an anchor element thereon, the anchor element configured for positioning beneath a tragus of the ear of the patient to thereby support positioning of the device; a first vagus nerve stimulating element, coupled to the electronics; wherein the electronics comprises an output circuitry to provide an output to the first vagus nerve stimulating element; and wherein, when the device is placed relative to the ear of the patient with the anchor element positioned beneath the tragus, the first vagus nerve stimulating element is positioned at the conchae.

22. The wearable vagus nerve modulation device of claim 21, further comprising a second extending structure having a first end at the housing and a second end apart from the housing configured for contacting the inferior crus of anti-helix and / or helix.

23. The wearable vagus nerve modulation device of claim 22, wherein the second end of the second extending structure carries a second vagus nerve stimulation element, such that, when the device is placed relative to the ear of the patient with the anchor element beneath the tragus, the second vagus nerve stimulating element is at the conchae cymba.

24. The wearable vagus nerve modulation device of either of claims 22-23, wherein the second extending structure has a variable length.

25. The wearable vagus nerve modulation device of any of claims 22-24, wherein the first vagus nerve stimulating element is positioned about 5 millimeters to about 10 mm apart from the second vagus nerve stimulating element.

26. The wearable vagus nerve modulation device of claim 25, wherein a spacing between the first vagus nerve stimulating element and the second vagus nerve stimulating element is adjustable.

27. The wearable vagus nerve modulation device of any of claims 22-26, wherein the second end of the second extending structure comprises a wing extending laterally therefrom, configured to fit under one of the inferior crus of antihelix and / or helix of the patient’s ear.

28. The wearable vagus nerve modulation device of any of claims 21-27, wherein the first vagus nerve stimulating element is an electrode.

29. The wearable vagus nerve modulation device of any of claims 21-27, wherein the first vagus nerve stimulating element is an optical output element.

30. The wearable vagus nerve modulation device of any of claims 21-27, wherein the first vagus nerve stimulating element is a mechanical transducer.

31. The wearable vagus nerve modulation device of any of claims 21-27, wherein the first vagus nerve stimulating element is a magnetic transducer.

32. The wearable vagus nerve modulation device of any of claims 21-31, wherein the first extending structure is located on a first side of the housing, and a second side of the housing opposite the first side comprises at least one control button or switch for controlling activity of the electronics.

33. The wearable vagus nerve modulation device of any of claims 21-32, wherein the first extending structure is located on a first side of the housing, and a second side of the housing opposite the first side comprises at least one optical indicator for providing an indication of a state of the wearable vagus nerve modulation device.

34. The wearable vagus nerve modulation device of any of claims 21-33, further comprising a clip adapted to secure over a superior aspect or posterior aspect of the helix of the ear.

35. The wearable vagus nerve modulation device of any of claims 21-34, further comprising an adhesive substrate for securing to the ear when the device is placed relative to the ear of the patient with the anchor arm extended beneath the tragus.

36. The wearable vagus nerve modulation device of any preceding claim, wherein the anchor arm is configured to extend into the auditory canal of the patient.

37. The wearable vagus nerve modulation device of any preceding claim, wherein the anchor arm extends at an angle of less than 90 degrees relative to a lengthwise edge of the housing.

38. The wearable vagus nerve modulation device of any preceding claim, wherein the anchor arm extends beyond the width of the housing.

39. The wearable vagus nerve modulation device of any preceding claim, wherein: the first extending structure has a width equal to the width of the housing and is positioned at a first end of the housing; and the anchor arm extends from the first extending structure beyond the width of the housing.

40. The wearable vagus nerve modulation device of any preceding claim, wherein the anchor arm is rotatably connected to the first extending structure.

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