Wearable devices, including for sleep apnea treatment systems, and associated methods
A wearable device around the neck tracks head and neck movements to efficiently deliver power and stimulation signals to implanted devices, addressing the discomfort and bulkiness of existing treatments for obstructive sleep apnea, enhancing compliance and treatment efficacy.
Patent Information
- Application Number
- PCT/US2025/012066
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2024-01-19
- Filing Date
- 2025-01-17
- Publication Date
- 2025-07-24
AI Technical Summary
Existing treatments for obstructive sleep apnea, such as CPAP machines and invasive surgical procedures, are uncomfortable, cumbersome, and have low compliance due to their bulkiness and requirement for invasive power transmission methods, especially for individuals with facial hair, leading to difficulties in aligning external power transmission devices with implanted devices.
A wearable device configured to be positioned around the neck, tracking head and neck movements without restriction, and wirelessly transmitting power and modulation signals to implanted devices near the hypoglossal nerve and ansa cervicalis nerve to stimulate muscles and maintain upper airway patency, using a system of support members, connectors, and power transmission devices to ensure consistent positioning and efficient power delivery.
The wearable device provides comfortable and effective treatment for obstructive sleep apnea by maintaining consistent positioning with the wearer's anatomy, enhancing power transmission efficiency, and improving compliance through reduced discomfort and unrestricted movement.
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Figure US2025012066_24072025_PF_FP_ABST
Abstract
Description
WEARABLE DEVICES, INCLUDING FOR SLEEP APNEA TREATMENT SYSTEMS, AND ASSOCIATED METHODSCROSS-REFERENCE TO RELATED APPLICATION
[0001] The present application claims priority to U.S. Provisional App. No. 63 / 622,921; filed on January 19, 2024; and titled “WEARABLE DEVICES, INCLUDING FOR SLEEP APNEA TREATMENT SYSTEMS, AND ASSOCIATED METHODS”; the entirety of which is hereby incorporated by reference herein.TECHNICAL FIELD100021 The present technology is directed to wearable devices, including wearable devices for sleep apnea treatment systems, and associated methods.BACKGROUND
[0003] Obstructive sleep apnea (OSA) is a medical condition in which a wearer's upper airway is occluded (partially or fully) during sleep, causing sleep arousal. Repeated occlusions of the upper airway may cause sleep fragmentation, which in turn may result in sleep deprivation, daytime tiredness, and / or malaise. More serious instances of OSA may increase the wearer's risk for stroke, cardiac arrhythmias, high blood pressure, and / or other disorders.
[0004] OSA may be characterized by the tendency for soft tissues of the upper airway to collapse during sleep, thereby occluding the upper airway. OSA is typically caused by the collapse of the wearer's soft palate, oropharynx, tongue, epiglottis, or combination thereof, into the upper airway, which in turn may obstruct normal breathing and / or cause arousal from sleep.
[0005] Some treatments have been available for OSA including, for example, surgery, constant positive airway pressure (CPAP) machines, and electrically stimulating muscles or related nerves associated with the upper airway to move the tongue (or other upper airway tissue). Surgical techniques have included procedures to remove portions of a wearer's tongue and / or soft palate, and other procedures that seek to prevent the tongue from collapsing into the back of the pharynx. These surgical techniques are very invasive. CPAP machines seek to maintain upper airway patency by applying positive air pressure at the wearer's nose and mouth. However, these machines are uncomfortable, cumbersome, and may have low compliance rates.
[0006] Some proposed OSA treatments include implanting one or more devices within a wearer to provide electrical stimulation that at least partially addresses the OSA. Many such implantable devices include an implanted power source, and implantation frequently requires invasive surgical intervention. Other implantable devices are powered from outside the body; however, existing techniques for transmitting power to wearers are often bulky and / or uncomfortable, leading to low wearer compliance. For example, external power transmission devices that adhere to a wearer’s skin with an adhesive can be uncomfortable (e.g., such as irritating the skin and / or pulling on the skin). This is particularly the case for individuals with facial hair. It can also be difficult to repeatably and / or consistently align external power transmission devices with one or more implantable devices.BRIEF DESCRIPTION OF THE DRAWINGS
[0007] FIG. 1 A is a side sectional view depicting a wearer's upper airway.
[0008] FIG. IB is a partially schematic illustration of representative neural structures and musculature of the wearer's lower jaw and neck.|0009| FIG. 1C is a perspective view of motion planes of the wearer’s lower jaw and neck.
[0010] FIG. 2A is a block diagram illustrating elements of a system for treating sleep disorders in accordance with embodiments of the present technology.
[0011] FIG. 2B is a side view the wearable device of FIG. 2A configured in accordance with embodiments of the present technology.
[0012] FIG. 2C is a side view the wearable device of FIG. 2A configured in accordance with embodiments of the present technology.|00l3| FIG. 3A is a plan view of a wearable device configured in accordance with embodiments of the present technology.
[0014] FIG. 3B is a perspective view of the wearable device of FIG. 3 A positioned around a wearer’s neck, in accordance with embodiments of the present technology.
[0015] FIG. 3C is a plan view of the wearable device of FIG. 3A and representative wearer musculature, in accordance with embodiments of the present technology.
[0016] FIGS. 4A and 4B are perspective views of another wearable device configured in accordance with embodiments of the present technology.DETAILED DESCRIPTION
[0017] The present technology is discussed under the following headings for ease of readability:Heading 1 : “Introduction”Heading 2: “Overall Physiology” (with a focus on FIGS. 1A-1C)Heading 3 : “Representative Wearable Devices and Associated Sleep Apnea Treatment System Elements” (with a focus on FIGS. 2A-4B)Heading 4: “Examples”|00l8[ While embodiments of the present technology are described under the selected headings indicated above, other embodiments of the technology can include elements discussed under multiple headings. Accordingly, the fact that an embodiment may be discussed under a particular heading does not necessarily limit that embodiment to only the elements discussed under that heading.1. Introduction[0019[ Electrical stimulation therapy for obstructive sleep apnea (OSA) typically includes delivering a modulation signal that modulates nerves and / or muscles to, e.g., cause the tongue and / or other soft tissue to move. The electrical stimulation can accordingly remove an obstruction of the upper airway, and / or prevent the tongue or other soft tissue from collapsing or obstructing the airway. As used herein, the terms “modulate” and “stimulate” are used interchangeably to mean having an effect on, e.g., a nerve and / or a muscle that in turn has an effect on one or more motor functions, e.g., a breathing-related motor function.10020] Representative methods and apparatuses for reducing the occurrence and / or severity of a breathing disorder, such as OSA, OSA with complete concentric collapse (“CCC”), central sleep apnea, and / or the like, are disclosed herein. In some embodiments, a signal delivery device is implanted at least proximate to or contacting one or more target tissues of the wearer’s upper airway, such as one or more nerves that innervate muscle(s) in the wearer’s airway and / or oral cavity. The signal delivery device can be implanted in the wearer via a minimally invasive percutaneous injection. The signal delivery device can receive power wirelessly from an external device and use that power to generate and / or deliver accurately targeted modulation signals (e.g., electrical signals, stimulation pulses, etc.) to the target tissues, thereby improving the wearer's upper airway patency and / or improve the tone of the tissue of the intraoral cavity to treat sleep apnea. The external device can include one or more mouthpiece portions, collar portions, chinstrapportions, pillow portions, mattress overlay portions, and / or one or more other suitable “wearables.”
[0021] Representative target tissues include nerves such as the hypoglossal nerve and / or the ansa cervicalis nerve, which are located adjacent and / or around the oral cavity or in the neck. Stimulating the hypoglossal nerve can cause the wearer’s tongue to move anteriorly / forward and / or prevent the tongue and / or other soft tissues in the airway from collapsing onto the back of the wearer’s pharynx and / or into the upper airway. Such movement of potentially obstructive tissue in the upper airway / pharynx is expected to improve the wearer’s sleep by mitigating or alleviating the obstruction. Stimulating the ansa cervicalis nerve can induce caudal traction (e.g., of the trachea), cause the hyoid bone to depress, and / or stabilize or stiffen the tongue and / or soft tissues of the upper airway. This, in turn, can reduce or prevent tissue collapse and / or other airflow obstructions in the wearer’s airway, thereby improving air flow through the upper airway and mitigating or even alleviating the breathing obstruction. Further target tissues can include one or more muscles innervated by the hypoglossal nerve or the ansa cervicalis nerve, the glossopharyngeal nerve, the pharyngeal branches of the glossopharyngeal nerve, the pharyngeal plexus, the C2 or C3 spinal nerve, a lateral part of the epidural space at the Cl, C2, and C3 vertebral bodies, the pharyngeal branches of the glossopharyngeal nerve, and / or other suitable and / or therapeutically effective targets.
[0022] Several embodiments of the present technology are described with reference to treating sleep apnea or other breathing obstructions. However, the present technology is not limited to these use cases and a person of ordinary skill in the art will appreciate that at least some embodiments of the present technology can be utilized to address problems with current wearable devices in additional and / or other fields. For example, many wearable devices configured to measure, augment, and / or otherwise address one or more head origin functions (e.g., speech, hearing, breathing, eating, swallowing, seeing, smell, feel, etc.) include a head contact element (eyeglasses, oxygen supply, respiration, hearing aids, helmets, head frames, head cradles, hats, ear muffs, ear plugs, chin straps, etc.) configured to support the device itself and / or one or more sensing elements configured to detect, measure, augment, or otherwise address one or more activities related to the head origin function. For example, continuous positive airway pressure (CPAP) machines and respirators include masks configured to cover the mouth and / or nose to provide CPAP therapy. As another example, many headsets and headphones include microphones and speakers to facilitate electronic communication. As a further example, augmented reality (AR) and / or virtual reality (VR) devices position display screens in front of a wearer’s eye, and mayinclude internally facing cameras for eye tracking and / or externally facing cameras to provide pass-through video. These and other wearable devices are secured to the wearer head and / or neck to maintain their position relative to target anatomical sites during use. The head and / or neck move frequently and through a considerable range of motion, and many daily functions (e.g., breathing, eating, speaking, etc.) involve jaw movement and are possible in many different head orientations. However, many existing wearable devices are bulky, heavy, unsightly, and / or restrict the wearer’s ability to move, which results in an undesirable, unpleasant, and / or otherwise uncomfortable experience. Embodiments of the present technology are lightweight, comfortable to wear, and securely fasten around the wearer’s neck without or substantially without restricting head and / or neck movement to provide a platform to which speakers, microphones, displays, and / or other functional components can be securely and stably coupled.
[0023] Many embodiments of the technology described below may take the form of or include computer- or machine- or controller-executable instructions, including routines executed by a programmable computer or controller. Those skilled in the relevant art will appreciate that the technology can be practiced on computer / controller systems other than those shown and described below. The technology can be embodied in a special-purpose computer, controller or data processor that is specifically programmed, configured or constructed to perform one or more of the computer-executable instructions described below. Accordingly, the terms “computer” and “controller” as generally used herein refer to any suitable data processor and can include Internet appliances and hand-held devices (including palm-top computers, wearable computers, tablets, cellular or mobile phones, multi-processor systems, processor-based or programmable consumer electronics, network computers, minicomputers and the like). Information handled by these computers can be presented at any suitable display medium, including a liquid crystal display (LCD). In some embodiments, manufacturers or other suitable entities can provide instructions to practitioners for executing the methods disclosed herein. Manufacturers can also program devices of the disclosed systems to carry out at least some of these methods.
[0024] The present technology can also be practiced in distributed environments where tasks or modules are performed by remote processing devices that are linked through a communications network. In a distributed computing environment, program modules or subroutines may be located in local and remote memory storage devices. Aspects of the technology described below may be stored or distributed on any suitable computer-readable media, including one or more ASICs, (e.g., with addressable memory), as well as distributedelectronically over networks. Data structures and transmissions of data particular to aspects of the technology are also encompassed within the scope of the embodiments of the technology.2. Overall Physiology
[0025] Representative embodiments described herein include wearable devices configured to position one or more sensors, power transmission devices, and / or other functional components relative to select portions of a patient’s anatomy and to maintain, or at least substantially maintain, a position of these components relative to the patient’s anatomy while the patient moves. In at least some embodiments, for example, the wearable devices of the present technology are configured to provide power to one or more signal delivery devices having electrodes that can be positioned to deliver one or more modulation signals to one or more specific target locations, e.g., specific nerves and / or specific positions along a nerve. Such locations include locations along the wearer's ansa cervicalis nerve, hypoglossal nerve, and / or vagus nerve, as well as those nerves that innervate muscles of the airway (e.g., palatal, oropharyngeal, laryngeal, omohyoid, sternohyoid, sternothyroid, thyrohyoid, nasal, lingual, pharyngeal, infrahyoid, diaphragmatic, and / or intercostal muscles). The target location can be identified with respect to any of, or any combination of, intrinsic or extrinsic muscles, associated nerve branches and / or portions thereof, and / or other physiological features. For example, some target locations can be within the wearer’s neck, such as at least proximate to the ansa cervicalis nerve, omohyoid muscle, sternohyoid muscle, sternothyroid muscle, and / or thyrohyoid muscle. Other target locations can be located superior to the neck and / or within or at least proximate to the wearer’s oral cavity, such as at least proximate to the hypoglossal nerve, at least proximate to the genioglossus muscle, and / or within the genioglossus muscle.
[0026] FIG. 1 A is a side sectional view depicting an upper airway of a wearer W (e.g., a patient or other person). The wearer W has a hard palate HP which overlies the tongue T and forms the roof of the oral cavity OC (e.g., the mouth). The hard palate HP includes bone support BS, and thus does not typically deform during breathing. The soft palate SP, which is made of soft tissue such as membranes, fibrous material, fatty tissue, and muscle tissue, extends rearward (e.g., in a posterior direction) from the hard palate HP toward the back of the pharynx PHR. More specifically, an anterior end AE of the soft palate SP is anchored to a posterior end of the hard palate HP, and a posterior end PE of the soft palate SP is unattached. Because the soft palate SP does not contain bone or hard cartilage, the soft palate SP is flexible and may collapse onto the back of the pharynx PHR and / or flap back and forth (e.g., especially during sleep).
[0027] The pharynx PHR, which passes air from the oral cavity OC and the nasal cavity NC into the trachea TR, is the part of the throat situated inferior to (below) the nasal cavity NC, posterior to (behind) the oral cavity OC, and superior to (above) the esophagus ES. The pharynx PHR is separated from the oral cavity OC by the palatoglossal arch PGA, which runs downward on either side to the base of the tongue T. Although not labeled for simplicity, the pharynx PHR includes the nasopharynx, the velopharynx, the oropharynx, and the laryngopharynx. The nasopharynx lies between the base of the cranium and the soft palate SP. The velopharynx is the section of the nasopharynx bounded ventrally by the soft palate. The oropharynx lies behind the oral cavity OC and extends from the soft palate SP to the pharyngoepiglottic fold. The oropharynx opens anteriorly into the oral cavity OC. The anterior portion of the oropharynx includes the base of the tongue T. A flap of connective tissue called the epiglottis EP closes over the glottis (not labeled for simplicity) when food is swallowed, to prevent aspiration. The laryngopharynx is the portion of the pharynx that divides anteriorly into the larynx and posteriorly into the esophagus, and is bounded by the pharyngoepiglottic fold superiorly and the upper esophageal sphincter inferiorly. Below the tongue T is the lower jaw or mandible M, and the geniohyoid muscle GH, which, along with the infrahyoid strap muscles, controls the movement of the hyoid bone HB.
[0028] FIG. IB is a partially schematic illustration of representative neural structures and musculature of the wearer's jaw J and neck N. The omohyoid muscle OHM extends between the hyoid bone HB and the scapula. The sternohyoid muscle SHM extends between the hyoid bone HB and the sternum ST, and the sternothyroid muscle STM extends between the sternum ST and the wearer's thyroid cartilage TH. The ansa cervicalis AC, and related branches emanating from the ansa cervicalis AC, innervate the omohyoid muscle OHM, the sternohyoid muscle SHM, and the sternothyroid muscle STM. The ansa cervicalis AC also extends at least partially parallel to and / or around the wearer’ s internal jugular vein IJV. FIG. IB also illustrates the wearer's mandible M, mylohyoid muscle MLH, and digastric muscle DG (more specifically, the anterior belly of the digastric muscle DG), as well as the sternothyroid muscle STM, sternocleidomastoid muscle SCM, and the sternohyoid muscle SHM. The sternohyoid muscles SHM and the sternothyroid muscles STM extend over (e.g., anterior to) the wearer’s larynx L. The muscles described above are contained within the wearer's oral cavity OC, neckN, and / or shoulder SH. By providing power to minimally invasive electrodes positioned at least proximate to one or more of the foregoing neural structures and / or associated musculature, embodiments of the present technology can direct one or more modulation signals to individual neural structures (e.g., single nerves or portions ofnerves associated with specific muscles or movements) and / or the associated musculature to control, reduce, and / or eliminate the effects of OSA and / or other breathing obstructions.
[0029] FIG. 1C is a perspective view of a head H and the neck N of the wearer W. The head H and / or neck N are highly mobile and can move (e.g., rotate) relative to pitch P, roll R, and / or yaw Y axes. The movement of the head H and the neck N are interrelated, but movement along the neck N is not always uniform. For example, when turning to the left, an upper portion of the neck N proximate the head H (represented by second plane 100b) can rotate or flex more (e.g., rotate or flex through a greater angle) than a lower portion of the neck N (represented by first plane 100a). The neck N can rotate in both the first plane 100a and the second plane 100b but at least a portion of the rotation in the second plane 100b can also be relative / in addition to the rotation in the first plane 100a. The first and second planes 100a,b are used for ease of reference. In practice, it will be appreciated that movement and / or rotation of individual cervical vertebra C1-C7 in the wearer’s neck N (shown schematically) can be interrelated and / or in response to movement and / or rotation of one or more others of the cervical vertebra C1-C7 about the pitch P, roll R, and / or yaw Y axes. For example, rotating the C7 cervical vertebra about the yaw axis Y can cause at least a corresponding rotation of one or more of the C1-C6 cervical vertebra. As another example, rotation of the head (e.g., to the right), each of the cervical vertebra C1-C7 can rotate (e.g., to the right), with Cl rotating by a greater amount than C2, C2 rotating by a greater amount than C3, etc.](>030[ Some wearable devices are configured to restrict or prevent movement of the head H and / or the neck N to consistently and repeatably position the wearable device relative to the wearer’s head H and / or neck N. However, devices that restrict neck movement are often uncomfortable and lead to low wearer compliance. As described in greater detail below, wearable devices of the present technology can be configured to be positioned at least partially around the wearer’s neck N to track or follow movement of the head H (or one or more of its elements including, e.g., the mouth, nose, eyes, ears, chin, etc.) and / or neck N without undue restriction while also carrying one or more power transmission devices, sensors, functional components, etc. For example, wearable devices that follow movement of the head H or neck N without, or at least substantially without, (a) discomfort that impacts daily activities or (b) pain or fatigue can be considered to track such movement without undue restriction. This enables consistent, easily repeatable, persistent positioning and placement of these components (sensors, power transmission devices, functional components, etc.), which in turn leads to increased operational efficacy, lower power consumption, and higher compliance. For example, easily and consistentlymaintaining the position of power transmission devices relative to one or more implanted signal delivery devices keeps a desired distance between these devices (e.g., reduces changes in the distance between these devices) to enhance power transmission efficiency.
[0031] Wearable devices in accordance with embodiments of the present technology are expected to track movement of various portions of the wearer’s head H and / or neck N, including overall movement (e.g., rotation in the first plane 100a and the second plane 100b) and relative movement (e.g., rotation in the second plane 100b relative to at least some or all rotation in the first plane 100a). For example, wearable devices in accordance with embodiments of the present technology can track (i) pitch, roll, and / or yaw of the head H and / or neck N; (ii) jaw movement with the head Hand / or neck N at various positions, (iii) movement of the head H and / or neck N relative to the wearer’s torso or other portions of the wearer’s anatomy, and / or (iv) other movement associated with the head H and / or neck N. This is expected to improve comfort, which is expected to improve compliance, while also allowing the wearable device to maintain an at least approximately consistent and / or repeatable position relative to the wearer’s head H and / or the neck N.3. Representative Wearable Devices and Associated Sleep Apnea Treatment System Elements
[0032] FIG. 2A is a block diagram illustrating elements of a system 200 for treating sleep disorders in accordance with embodiments of the present technology. The system 200 can include a wearable device 210, a charger 206, one or more implants or implantable devices (e.g., a first implantable device 202a, a second implantable device 202b . . . an nth implantable device 202n; referred to collectively as “implantable devices 202”) and a connected device or programmer 204. In general, the programmer 204 can transmit instructions for generating a modulation signal (e.g., signal delivery or waveform parameters) to the wearable device 210, the wearable device 210 can transmit the instructions and power to the implantable device(s) 202, and individual implantable devices 202 can collectively and / or independently generate modulation signals according to the transmitted instructions and apply the modulation signals to a wearer via electrodes carried by the implantable device(s) 202. At least some elements of the system 200 (e.g., the wearable device 210, the charger 206, the implantable devices 202, etc.) can be at least generally similar or identical in structure and / or function to one or more elements described in U.S. Pat. App. No. 17 / 851,718, the entirety of which is hereby incorporated by reference herein.
[0033] In some embodiments, the implantable devices 202 can include one or more capacitors and / or other devices configured to store a charge (e.g., for no more than 1 second, 2 seconds, 3 seconds, 4 seconds, 5 seconds, 10 seconds, 20 seconds, 30 seconds, 1 minute, 2 minutes, 3 minutes, 4, minutes, or 5 minutes). In some embodiments, the implantable devices do not include a battery, power capacitor (e.g., a super capacitor), and / or other power storage element configured to store a charge for extended periods of time (e.g., at least 1 hour, 6 hours, 12 hours, 1 day, 1 week, 1 month, etc.) for powering the implantable devices 202 for prolonged periods of time in the absence of wirelessly delivered power. In other embodiments, one or more of the implantable devices 202 include one or more power storage elements configured to storage a charge for extended periods of time. Such implantable devices can be configured for use with wearable devices that omit power transmission devices. Individual implantable devices 202 can be implanted in a wearer to deliver a modulation signal to one or more portions of the hypoglossal nerve HGN (including the anterior branches AB and / or the distal brachiated portions DB (FIG. 2B), the genioglossus muscle GG, the ansa cervicalis muscle, and / or one or more other stimulation targets described herein.
[0034] The programmer 204 can include a patient-operated programmer and / or a clinician-operated programmer and can be configured to control one or more characteristics of the modulation signal delivered to the wearer. In a representative embodiment, the programmer 204 can include a therapy adjustment module configured to select one or more of the electrodes carried by the implantable device(s) 202 and to adjust an amplitude, frequency, pulse width, burst duration, whether the electrode is active or inactive, and / or any other suitable signal delivery parameter. Additionally, the programmer 204 can synthesize information (e.g., diagnostic and / or feedback information) received from a user, the wearable 210, and / or the individual implantable devices 202 and can adjust one or more of the signal delivery parameters based at least partially on the synthesized information. For example, the programmer 204 can be configured to direct the modulation signal to specific distal brachiated portions DB (FIG. 2B) based, at least in part, on a tissue collapse pattern of the wearer.
[0035] The programmer 204 can transmit the signal delivery parameters to the implantable device(s) 202 directly and / or via the wearable device 210. For example, the programmer 204 can be connected to individual implantable devices 202 and / or the wearable device 210 via a wired or wireless communication link, such as WiFi, Bluetooth (“BT”), cellular connectivity, and / or any other suitable communication link. In these and other embodiments, the programmer 204 can be connected to the “cloud” 208 and / or other computer service(s), e.g., toupload data received from the wearable device’s 210 sensors and / or to download information to the wearable device 210 and / or the implantable device(s) 202. In these and other embodiments, the programmer 204 can include a display and / or a user interface. A user (e.g., the wearer, the patient, the clinician, and / or other suitable user) can interact with and / or otherwise control one or more aspects of the programmer 204 via the user interface, e.g., to manually adjust one or more of the signal delivery parameters, to read data received from the wearable device 210 sensors, provide one or more inputs corresponding to a tissue collapse pattern, and / or carry out other tasks.
[0036] The wearable device 210 can have any of the features and / or form factors described herein with reference to FIGS. 3A-4B. The wearable device 210 can include one or more sensors (e.g., a single sensor, an array of sensors, and / or other suitable sensor arrangements) configured to collect data associated with a wearer. Representative data received from the wearer can include respiratory rate, sleep state, wake state, heart rate, audio signals (corresponding to audible snoring, hypopnea events, and / or apnea events), body temperature, head orientation / position, saturated blood oxygen levels, air flow levels, thyroid movement, trachea movement, tongue movement, and / or photoplethysmography (PPG) data, among others, each of which can be received by a corresponding type of sensor (e.g., heart rate data from a heart rate sensor, head orientation / position data from an accelerometer, etc.). These data can be received via one or more corresponding sensors (e.g., body temperature from a temperature sensor, audio signals from a microphone or other audio sensor, etc.), and can correspond to a measure of the wearer’s respiratory performance, sleep state, wake state, and / or other suitable metrics, for example, metrics that are used to rate the wearer on the Apnea-Hypopnea Index (AHI). Additionally, or alternatively, the wearable device 210 can receive data from the individual implantable devices 202, e.g., using backscatter, pulse width modulation, frequency modulation, and / or one or more other suitable techniques. For example, the implantable devices 202 can transmit a receipt to indicate that power has been received and what magnitude the power is. This information can be used to autoregulate (up or down) the output of the implantable device’s pulse generator, e.g., the transmitted signal and phase.
[0037] The wearable device 210 can further include a power source (e.g., a stored power device such as battery), one or more power transmission devices configured to transmit power and / or signal delivery parameters to the implantable device(s) 202, and one or more algorithms configured to control one or more aspects of the operation of the wearable device 210. Individual sensors can collect data associated with the wearer, such as a wearer’ s sleep state and / or respiratory performance. The one or more algorithms can be configured to adjust at least one ofthe signal delivery parameters based at least partially on the data collected by the sensors. In a representative embodiment, the wearable 210 can include an integrated sleep, respiratory diagnostics, and / or therapy modulation system configured to adjust or otherwise control one or more delivery parameters of the modulation signal delivered to the wearer based on the collected sleep state and / or respiratory performance data, e.g., via one of more algorithms.
[0038] In some embodiments, the wearable device 210 can further include a cover or housing, at least a portion of which may be removeable, e.g., to expose an interior or interior portion of the wearable device 210. In these and other embodiments, the cover can include fabric, or any other suitable material. Optionally, the wearable device 210 can include a reduced-scope and / or simplified user interface configured to allow a user to interact with and / or otherwise control one or more of the elements of the wearable device 210, e.g., without using the programmer 204. For example the wearable device user interface may allow the user to check a charging status of the power source, power on and / or off the wearable device 210, adjust one or more of the signal delivery parameters, configured and / or verify therapy delivery, select one or more therapy presets, confirm and / or verify placement of the wearable device, etc.
[0039] The charger 206 for the wearable device 210 can be configured to supply power to the wearable device’s 210 power source. The charger 206 can include a wireless (e.g., inductive) charger, a wired charger (e.g., wall-plug, charging cable, etc.), and / or any other suitable charger or charging device. Optionally, the charger 206 can include an integrated controller and / or a connected device, e.g., to control the charging of the wearable device 210 and / or to upload / download data to the wearable device 210 while the wearable device 210 is charging.
[0040] The one or more implantable devices 202 can each include an RFID component (e.g., a unique RFID tag that can be used to identify and / or locate the associated implantable device 202a-n), a power receiving device (e.g., one or more RF power antennas, one or more inductive coils, etc.), a power rectifier / DC-DC converter, circuitry (e.g., one or more application-specific integrated circuits (ASICs), a state machine, etc.), a signal generator, and two or more electrodes that are each individually selectable to deliver a modulation signal to a wearer. The power receiving device can receive power from the power transmission component (e.g., one or more RF power antennas, one or more inductive coils, etc.) of the wearable device. The power rectifier / DC-DC converter can be operably coupled to the electrode receiver antenna and can be configured to transmit the received power to the signal generator. Additionally, each of the implantable devices 202 can receive, via the power receiving device and / or one or more othercommunication components, information regarding one or more of the delivery parameters of the modulation signal to be generated by the signal generator and / or delivered to the wearer via at least one of the electrodes of the implantable device(s) 202. The circuitry can include machine- readable instructions associated with the operation of the implantable device(s) 202. For example, the circuitry can include instructions that, when executed, can cause the signal generator to generate the modulation signal having the signal delivery parameter(s) received via the electrode receiver antenna. In these and other embodiments, the power receiving device and / or the one or more other communication components can be used to transmit information associated with the implantable device 202 to the wearable device 210. For example, the implantable device 202 information to the wearable device 210 associated with one or more of the signal delivery parameters of the modulation signal being applied to the wearer. In these and other embodiments, one or more of the implantable devices 202 can include a hermetic package or housing configured such that the implantable device(s) 202 can be implanted within a wearer.[00411 In some embodiments, one or more of the implantable devices 202 are passive devices that do not include an onboard pulse generator configured to generate modulation signals. Instead, the passive implantable device can wirelessly receive a power signal from the wearable device 210 and transmit the received power signal to the wearer via the electrodes. The passible implantable device may condition or otherwise process the received power signal, but does not use the received power signal to power an onboard pulse generator.(0042] FIG. 2B is a side view the wearable device 210. In the illustrated embodiment, the wearable device 210 is configured to be worn on or near an underside of the wearer’s jaw J. In this position, the wearable device 210 can be configured to transmit power energy E, such as electromagnetic radiation in the form power and / or modulation signals via one or more of the power transmission devices 212a, b to an implantable device 202 positioned at least proximate to the hypoglossal nerve HGN and / or one or more distal branches DB thereof.(0043] FIG. 2C is another side view of the wearable device 210. In the illustrated embodiment, the wearable device 210 is configured to be worn on or at least partially around the wearer’s neck N. In this position, the wearable device 210 can be configured to transmit energy E, such as electromagnetic radiation in the form power and / or modulation signals via one or more of the power transmission devices 212a,b to an implantable device 202 positioned at least proximate to the ansa cervicalis AC.
[0044] Both FIG. 2B and 2C illustrate embodiments in which the wearable device210 is configured to transmit power to one target location within the wearer W, i.e., at least proximate to the hypoglossal nerve HGN in FIG. 2B and at least proximate to the ansa cervicalis nerve AC in FIG. 2C. In other embodiments, the wearable device 210 can be configured to transmit power to multiple target locations within the wearer, such as at least proximate to the hypoglossal nerve HGN (e.g., as in FIG. 2B) and at least proximate to the ansa cervicalis nerve AC (e.g., as in FIG. 2C). In the illustrated embodiment, the wearable device 210 includes more power transmission devices 212 than there are implantable devices 202. Having more power transmission devices 212 than implantable devices 202 enables the wearable device 210 to dynamically select one of the power transmission devices 212, or a subset of the power transmission devices 212, to provide power to a given implantable device 202. For example, the power transmission device(s) 212 can be selected based at least in part on which of the power transmission device(s) 212 is closest to the implantable device 202 and / or has the best coupling with a power receiving component carried by the implantable device 202. The wearable device 210 can accordingly compensate for migration and / or other movement of the power transmission device(s) 212 relative to the patient and / or the implantable device 202. For example, during sleep, movement by the wearer can cause the wearable device 210 to move in relation to the wearer by, e.g., a few centimeters. Since migration of the wearable device 210 can disrupt or otherwise effect power transmission to the implantable device 202, having multiple power transmission devices 212 at various locations on the wearable device 210 enables the wearable device 310 to continuously provide therapy even after the wearable device 210 migrates. This is achieved, for example, by dynamically switching to the power transmission device(s) that provides the best coupling with the implantable device(s), which is generally the power deliver device that is closest to the implantable device at any given moment.
[0045] FIG. 3 A is a front view of a wearable device 310 configured in accordance with embodiments of the present technology. The wearable device 310 can include a first or primary support member 314a, a second or secondary support member 314b, an anterior connector 316, one or more posterior connection members 318 (individually identified as a first posterior connection member 318a and a second posterior connection member 318b), and a loop portion 320. The first support member 314a can include an elongate first body extending between a first or superior end portion 322a and a second or inferior end portion 322b. The second support member 314b can include an elongate second body extending between a first or superior end portion 324a and a second or inferior end portion 324b. The first and / or second support members314a, 314b can include one or more polymers (e.g., polyimide, Nylon 6 / 6, low modulus polycarbonate, polypropylene, etc.), metals (e.g., Nitinol) and / or other suitable materials. The first and / or second support members 314a, 314b can be at least generally rigid, e.g., configured to at least partially resist deformation and / or otherwise maintain their shape in response to externally applied forces. The second support member 314b can be bilaterally symmetrical to and / or a mirror of the first support member 314a, e.g., about a longitudinal axis L-L of the wearable device 310, such as shown in FIG. 3 A. When the wearable device 310 is worn, the longitudinal axis L-L can correspond to an inferior-superior axis, a cranial-caudal axis, and / or a mid-sagittal plane of the wearer W. When viewed from the front, as in FIG. 3 A, the first support member 314a and the second support member 314b can be angled outwardly from the longitudinal axis L-L in the inferior-to-superior direction, such that the inferior end portions 322b, 324b of the first and second support members 314a, 314b can be positioned closer to the longitudinal axis L-L than the superior end portions 322a, 324a. This outwardly angling of the first and second support members 314a, 314b can help the wearable device 310 track, follow, and / or otherwise move with movement of a wearer’s head and / or neck, as described below with reference to at least FIG. 3C.
[0046] The anterior connector 316 can include one or more straps, ties, bindings, and / or other suitable connection members and can extend between and / or couple the inferior end portion 322b of the first support member 314a to the inferior end portion 324b of the second support member 314b. The anterior connector 316 can have a length that is adjustable, for example, to help seat the first support member 314a and / or the second support member 314b comfortably and / or securely against select portions of the wearer’s anatomy, which is expected to help the wearable device 310 track, follow, and / or otherwise move with movement of a wearer’s head and / or neck, as described below with reference to at least FIG. 3C. In some embodiments, the anterior connector 316 can be flexible and / or otherwise configured to undergo at least generally elastic deformation, for example, to allow the inferior end portions 322b, 324b of the first and second support members 314a, 314b to move relative to one another. In other embodiments, the anterior connector 316 can be generally inflexible, have a fixed or unchanging length, and / or be otherwise configured to at least partially resist, or even prevent entirely, the inferior end portions 322b, 324b from moving relative to one another.
[0047] The first posterior connection member 318a can be coupled to the first support member 314a, e.g., between the superior end portion 322a and the inferior end portion 322b, and can include a one or more first coupling features 326a. The second posterior connection member 318b can be coupled to the second support member 314b, e.g., between the superior endportion 324a and the inferior end portion 324b, and can include one or more second coupling features 326b. The first coupling features 326a and the second coupling features 326b can be configured to couple (e.g., releasably couple) to one another to join the first posterior connection member 318a with the second posterior connection member 318b, e.g., to from an overall posterior connection member (“posterior connector 318”). Each of the coupling features 326a, b can include one or more buckles, clasps, Velcro® and / or other hook and loop closures, snap closures, zippers, magnetics, magnetic claps, magnetic snaps, adhesives, self-adhesive sections, laces, and / or other suitable coupling features. The posterior connector 318 can have a length that is adjustable, for example, to help seat the first support member 314a and / or the second support member 314b comfortably and securely against select portions of the wearer’ s anatomy. This, in turn, is expected to help the wearable device 310 track, follow, and / or otherwise move with movement of a wearer’s head and / or neck, as described below with reference to at least FIG. 3C.|0048| The loop portion 320 can have a first end portion 328a and a second end portion 328b and can include one or more elongate elements (e.g., wires, filaments, etc.) extending at least partially between the first and second end portions 328a, b. The first end portion 328a can be operably coupled to the superior end portion 322a of the first support member 314a at a first connection point or joint 330a. The second end portion 328b can be operably coupled to the superior end portion 324b of the second support member 314b at a second connection point or joint 330b. The loop portion 320 can be flexible and / or otherwise configured to undergo at least generally elastic deformation, e.g., in response to movement of the user’s head and / or neck. In at least some embodiments, for example, the loop portion 320 includes a shape memory material such as Nitinol configured to return to a “memorized” shape or configuration in the absence of externally applied force. The ability of the loop portion 320 to track movement of the wearer’s head and / or neck can be based, at least partially, on the shape (e.g., nominal shape, shape under force, curvature, etc.) of the loop portion 320. In some embodiments, the loop portion 320 is generally flexible but includes a more rigid section along its length, e.g., the loop portion 320 can include a wire and the rigid section can be coupled to the wire, or the rigid section can be connected to the first and second support members 314a,b by respective wire segments coupled to the rigid section.
[0049] The wearable device 310 can be configured to transmit power (e.g., wirelessly) to one or more implantable devices (e.g., the implantable devices 202 of FIGS. 2A- 2C). For example, the wearable device 310 can include one or more power transmission devices 312 (shown schematically in dashed lines, and individually identified as first through fourth powertransmission devices 312a-d, respectively) and / or an electronics housing 332. In some embodiments, the wearable device 310 can include as many power transmission devices 312 as there are implanted devices (e.g., one power transmission device for one implantable devices, two power transmission devices for two implantable devices, etc.). In other embodiments, the wearable device 310 can include a number of power transmission devices 312 that is greater or less than the number of implantable devices (e.g., one power transmission device for two implantable devices, two power transmission devices for one implantable devices, etc.). One advantage to having more power transmission devices 312 than implantable devices is the ability to identify the power transmission device(s) closest to the implantable devices and use the identified power transmission device(s) to transmit power to the implantable device, which is expected to improve power transmission efficiency.
[0050] The wearable device 310 can be configured to hold the respective power transmission devices 312 against the neck with sufficient force (e.g., a sufficient uniform circumferential compressive force, including between 0.01 pounds per square inch (PSI) and 1 PSI ) to maintain a position of each of the power transmission devices 312 relative to one or more devices implanted within the wearer while also being comfortable for the wearer (e.g., without or substantially without skin blanching or contact pressure that could cause pressure or shear on the skin to irritate it). The illustrated embodiment of the wearable device 310 includes four power transmission devices 312a-d, coupled to the first support member 314a, the second support member 314b, and the loop portion 320, respectively. Additionally, or alternatively, the wearable device 310 can include one or more power transmission devices 312 coupled to the anterior connector 316, the posterior connector 318, the loop portion 320, the electronics housing 332, and / or at one or more other suitable locations. In these and / or other embodiments, the power transmission devices 312 can be positioned based, at least in part, on the target site within the wearer at which one or more implanted devices are to be positioned.
[0051] Although the power transmission devices 312 are described as being configured to transmit power to one or more implantable devices, in some embodiments one or more of the power transmission devices 312 are configured to provide transcutaneous modulation signals to one or more target locations within the wearer’s neck N. For example, at least one of the power transmission devices 312 can be positioned to transcutaneously modulate the ansa cervicalis and / or one or more of the muscles innervated thereby. In such embodiments, the modulation signals can be electrical signals or magnetic signals, and the wearable device 310 can deliver the modulation signals without using the implantable devices 202.
[0052] The electronics housing 332 can contain one or more batteries, processors, computer memory, and / or other components operable (e.g., independently or in combination) to cause one or more of the power transmission devices 312 to transmit power. In some embodiments, the electronics housing 332 is coupled to the posterior connector 318, e.g., to be positioned on a posterior side of a wearer’s neck when the wearable device 310 is worn (e.g., to reduce or prevent interfering with caudal traction and / or other movement at or near an anterior side of the neck N during treatment). In other embodiments, the electronics housing 332 and / or one or more of the electronic components contained therein can be carried by or otherwise coupled to one or more other portions of the device 310, such as one of the support members 314.
[0053] In some embodiments, the wearable device 310 includes one or more functional components 334 (shown schematically and in dashed line). The functional components 334 can include one or more sensors, such as one or more microphones, photoplethysmography (PPG) sensors, temperature sensors, heart rate sensors, electromyography (EMG) sensors, accelerometers, movement sensors, contact sensors, acoustic sensors, pressure sensors, breath sensors, flow sensors, oxygen sensors, moisture sensors, strain sensors, rotation sensors, inclinometers, light sensors, capacitive sensors, and / or other suitable sensors. Additionally, or alternatively, the functional components 334 can include one or more cameras, display screens, speakers, Light Detection and Ranging (LiDAR) devices, Radio Detection and Ranging (RADAR) devices, Sound Detection and Ranging (SONAR) devices, haptic feedback devices, user interfaces, and / or other suitable functional components.
[0054] The functional components 334 are illustrated as being coupled to the loop portion 320 in FIG. 3 A. Because the loop portion 320 can be configured to contact a wearer’s jaw when the wearable device 310 is worn, it may be advantageous to couple sensors configured to detect snoring, speech, breathing, airflow, etc., to the loop portion 320 (or one or more rigid sections of the loop portion) so that they can be positioned proximate the wearer’s jaw when the wearable device is worn without, or substantially without, obstructing other natural and / or head origin functions such as speech, chewing / eating, swallowing, smelling, breathing, seeing, etc. In other embodiments, however, all or a subset of the function components 334 can be coupled to the first support member 314a, the second support member 314b, the anterior connector 316, and / or the posterior connector 318 without, or substantially out, obstructing other natural and / or head origin functions. In at least some embodiments, for example, the functional components 334 include one or more PPG sensors coupled to the first support member 314a, the second support member 314b, and / or the posterior connector 318 at location(s) that align the PPG sensors withone or more blood vessels in the wearer’s neck when the wearable device 310 is worn. Additionally, or alternatively, the functional components 334 can include one or more accelerometers, strain gauges, rotation sensors, etc. at one or more of the joints 330a, b to measure bending, deflection, and / or other movement of the loop portion 320. This data can, in turn, be used to detect whether the wearer is moving their jaw, e.g., to speak, chew, breathe, etc. In these and / or other embodiments, one or more capacitive sensors can be coupled to the first support member 314a and / or the second support member 314b and data from these sensors can be used to determine whether the wearer is wearing the wearable device 310. In some embodiments, the user can touch, press, tap, or otherwise interact with one or more capacitive sensors and / or other functional components 334 to control the operation of the wearable device 310, such as to start or stop power transmission. Because the loop portion 320 and / or the support members 314a,b can maintain a position of one or more of the functional components 334 (e.g., sensors) relative the wearer’s head and / or neck, the loop portion 320 can allow the functional components 334 to obtain accurate data associated with the wearer’s head (e.g., sound detection, airflow measurements, eye tracking, speech detection, etc.) while the wearer moves their head through a wide range of motion.
[0055] In some embodiments, the first support member 314a, the second support member 314b, the anterior connector 316, the posterior connector 318, and / or the loop portion 320 can include one or more contact surfaces. While these and / or other portions of the wearable device 310 may contact, and / or be configured to contact, the neck N when the wearable device 310 is worn, the contact surfaces can be configured to have increased friction relative to all, or at least a subset, of these other portions of the wearable device 310. For example, in at least some embodiments individual contact surfaces can include silicone and / or one or more other materials configured to reduce to prevent movement of the wearable device 310 relative to the head H and / or neck N, and / or improve overall wearer comfort (e.g., hypoallergenic, biocompatible, durable, etc.). Additionally, or alternatively, one or more of the contact surfaces can be textured or include friction-increasing features, such as one or more ridges, adhesives, etc.
[0056] In some embodiments, the wearable device 310 can include a covering configured to extend at least partially or fully around all, or at least a subset, of the wearable device 310. For example, the first support member 314a and / or the second support member 314b can be fully contained within the covering. In some embodiments, the covering is removable for cleaning and / or to provide access to various components contained within the covering.
[0057] FIG. 3B is a perspective view of the wearable device 310 positioned around the neck N of the wearer W, in accordance with embodiments of the present technology. When worn, the anterior connector 316 can contact an anterior portion of the wearer’s neck N and the posterior connector 318 can contact a posterior portion of the wearer’s neck N, e.g., opposite the anterior portion and / or the anterior connector 316. In some embodiments, the anterior connector 316 and the posterior connector 318 can be combined to form a single connector or loop that extends along anterior and posterior surfaces of the neck N.
[0058] The first support member 314a and the second support member 314b can extend posteriorly in the inferior-to-superior direction, such that the superior end portions 322a, 324a of the first and second support members 314a, 314b can be positioned posteriorly from the inferior end portions 322b, 324b. The support members 314a, 314b can position one or more power transmission devices (e.g., the power transmission device 312b) to transmit power to one or more devices implanted within the wearer’s neck N, e.g., to target the ansa cervicalis and / or associated muscles. The loop portion 320 can contact an underside of the wearer’s jaw J and position one or more power transmission devices (e.g., the power transmission device 312d) to transmit power to one or more devices or device portions implanted within or near the wearer’s jaw J, e.g., to target the hypoglossal nerve, one or more of the anterior branches thereof, and / or associated muscles. As noted above, the loop portion 320 can be flexible and configured to bend and / or deflect in response to movement of the wearer’s jaw J. For example, the loop portion 320 can flex (e.g., bend, twist, etc.) to follow or otherwise accommodate at least 50%, 60%, 70%, 80%, 90%, or 100% of the movement of the jaw J, including movements associated with sleeping, breathing, talking, eating, etc. Accordingly, individual power transmission devices coupled to the loop portion 320 (e.g., power transmission device 312d) can readily follow at least 50%, 60%, 70%, 80%, 90%, or 100% of the movement of the jaw J. This range of motion of the power transmission devices 312 is expected to improve the positioning / alignment of these power transmission devices 312 with one or more signal delivery devices (e.g., devices 202) implanted within the wearer. By maintaining the relative position between the power transmission devices 312 and corresponding target sites on the wearer’s exterior anatomy, the wearable device 310 can reduce or entirely prevent changes in the distance between the power transmission devices 312 and corresponding implanted signal delivery devices 202. This is expected to enhance power transmission efficiency and reduce heat.
[0059] In some embodiments, the anterior connector 316, the posterior connector318, and the loop portion 320 can be configured to maintain their positions relative to the wearer’ sanatomy, and by extension the position of the support members 314 relative to the wearer’s neck N, by balancing forces applied to the wearer’s anatomy. For example, the anterior connector 316 can exert an anteriorly directed force on the support members 314 to, e.g., bias the inferior end portions 322b, 324b of the support members 314 in the anterior direction. The posterior connector 318 can exert a posteriorly directed force on the support members 314 to, e.g., bias the superior end portions 322a, 324a of the support members 314 in the posterior direction. This biasing of the inferior and superior end portions 322, 324 can seat the support members 314 in the posteriorly and superiorly angled orientation shown in FIG. 3B. Because the posterior connector 318 is coupled to the support members 314 at locations superior to the anterior connector 316, the forces from the posterior connector 318 (if left unopposed) could draw the superior end portions 322a, 324a in the posterior direction, rotate the support members 314 accordingly, and cause the wearable device 310 to fall off the wearer’s neck N. However, the loop portion 320 can contact the wearer’s jaw J to prevent, or at least partially prevent, the superior end portions 322a, 324a from being drawn in the posterior direction by the posterior connector 318. This can help to maintain the positions of the support members 314 relative to the wearer’s neck N and maintain comfortable, conformable, and snug fit of the wearable device 310 on the neck N. 0060] The electronics housing 332, coupled to the posterior connector 318, can be positioned at a posterior side of the neck N. As shown in FIG. 3B, the posterior side of the neck can define a natural concavity and, accordingly, positioning the electronics housing 332 at or near this concavity is expected to reduce, or even prevent, wearer discomfort at least when the wearer is supine. Additionally, when the wearer moves their head H and / or neck N, the posterior side of the neck N is expected to undergo less movement relative to the anterior side and, accordingly, positioning the electronics housing 332 at or near the posterior side of the neck N is expected to reduce, or even prevent, interference with the wearer’ s ability to freely move their neck N. In some embodiments, the electronics housing 332 can be curved or otherwise contoured based, at least in part, in the curvature of the posterior side of the neck N, e.g., to further improve wearer comfort and / or further reduce interference with the wearer’s ability to freely move their neck N[00611 FIG. 3C is a front view of the wearable device 310 positioned around the neck N of the wearer P, in accordance with embodiments of the present technology. When the wearable device 310 is worn, the first support member 314a can be configured to be positioned at least partially along and / or at least partially aligned with a first or right sternocleidomastoid muscle SCM-R of the wearer P and / or the second support member 314b can be configured to be positioned at least partially along and / or at least partially aligned with a second or leftsternocleidomastoid muscle SCM-L of the wearer P. For example, the right sternocleidomastoid muscle SCM-R can extend along a first length and, when the wearable device 310 is positioned around the neck N, the first support member 314a can be positioned parallel to, or within up to 45 degrees, 35 degrees, 30 degrees, 25 degrees, 20 degrees, 15 degrees, 10 degrees, 5 degrees, or 1 degree of being parallel to, the first length. Similarly, the left sternocleidomastoid muscle SCM- L can extend along a second length and, when the wearable device 310 is positioned around the neck N, the second support member 314b can be positioned parallel to, or within at least 45 degrees, 35 degrees, 30 degrees, 25 degrees, 20 degrees, 15 degrees, 10 degrees, 5 degrees, or 1 degree of being parallel to, the second length. The sternocleidomastoid muscles SCM-L, R, which connect the head H to the sternum ST and serve to turn and nod the head H, present large surfaces that the wearable device 310 can contact and act as an anatomical fiducial to, for example, register the position and / or orientation of the wearable device 310 relative to the wearer’s neck and / or one or more target sites for stimulation. Additionally, aligning the support members 314a, 314b with the sternocleidomastoid muscles SCM-L, R can allow the movement of the sternocleidomastoid muscles SCM-L, R to drive corresponding movement of the support members 314a, 314b (and, by extension, movement of one or more other portions of the wearable device 310), such that each of the support members 314a, 314b are expected to move at least generally with the respective neck portions about which the support members 314a, 314b are seated, e.g., without or generally without slipping and / or inhibiting movement of the neck N. For example, in response to a movement of the wearer’s head H and / or neck N, the support members 314a, 314b can follow (e.g. track) at least approximately 50%, 60%, 70%, 80%, 90%, or 100% of the movement of the sternocleidomastoid muscle SCM-L, R and / or other neck portion against which the support members 314a, 314b are seated. Accordingly, any devices and / or components coupled to the support members 314a, 314b (e.g., power transmission devices 312a, 312b) can undergo and / or maintain contact with the neck N for up to approximately 50%, 60%, 70%, 80%, 90%, or 100% of the movement of the corresponding portion of the neck N about which the corresponding support member 314a, 314b is seated. This range of motion of the power transmission devices 312 is expected to improve the positioning / alignment of these power transmission devices 312 with one or more signal delivery devices implanted within the wearer. By maintaining the position of one or more of the power transmission devices 312 relative to a corresponding portion of or location on the wearer’s exterior anatomy, the wearable device 310 can reduce, or even prevent entirely, changes in the distance between the power transmission devices 312 and the one or moreimplanted signal delivery devices that alter power transmission characteristics, such as reductions in power transmission efficiency.
[0062] The anterior connector 316 and the posterior connector 318 can be configured to align the support members 314a, 314b with the sternocleidomastoid muscles SCM-L,R. As noted above, the anterior and / or posterior connectors 316, 318 can be at least generally flexible and, accordingly, the anterior and / or posterior connectors 316, 318 can stretch or compress in response to movement of the support members 314a, 314b while also holding the support members 314a, 314b firmly against the sternocleidomastoid muscles SCM-L,R. Additionally, or alternatively, the anterior connector 316 and / or the posterior connector 318 can have a length that is adjustable, e.g., through a range of values to provide a comfortable fit for many differently sized necks.
[0063] FIG. 4A is a side view of another wearable device 410 configured in accordance with embodiments of the present technology, and FIG. 4B is a perspective view of the wearable device 410 positioned around a wearer’s N, in accordance with embodiments of the present technology. Referring to FIG. 4A, the wearable device 410 can include features that are at least generally similar or identical in structure and / or function to one or more features of the wearable device 310. For example, the wearable device 410 includes a first or primary support member 414a, a second or secondary support member 414b, an anterior connector 416, a posterior connector 418, an electronics housing 432 coupled to the posterior connector 418, and a loop portion 420, each of which can be at least generally similar or identical in structure and / or function to the correspondingly named and / or numbered feature of the wearable device 310 (e.g., first support member 414a versus first support member 314a). Additionally, the wearable device 410 includes a cup or contact portion 436 configured to contact and act as an anatomical fiducial to, for example, register the position and / or orientation of the wearable device 410 relative to the wearer’s chin and / or jaw. For example, the contact portion can be shaped to have a contour that is at least substantially similar to that of a portion of the wearer’ s chin and / or can at least substantially conform to the shape of a portion of the wearer’s chin. This is shown, for example, in FIG. 4B. Returning to FIG. 4 A, the cup 436 can be coupled to the loop portion 420 and sized to provide a larger contact surface than the loop portion 420. This is expected to help a user align the wearable device 410 with their anatomy and improve user comfort when the user moves their jaw and bends / deflects the loop portion 420 (e.g., the larger contact surface can reduce uncomfortable point loads on the wearer’s lower jaw).
[0064] Accordingly, in some aspects of the present technology, a wearable device can include a pair of support members coupled together by connectors. The support members device can be configured to be positioned along the wearer’s sternocleidomastoid muscles and track movement of the head H and / or neck N without undue restriction. For example, when a wearer moves their head and / or neck, the wearable device and / or individual components coupled thereto can undergo up to 50%, 60%, 70%, 80%, 90%, or 100% of that movement. This enables consistent, easily repeatable, persistent positioning and placement of these components, which leads to increased efficacy of the therapy, lower power consumption and higher wearer compliance.4. Examples
[0065] The following examples provide further embodiments of the present technology:1. A wearable device configured to be worn at least partially around a neck of a wearer, the wearable device comprising: a first support member configured to be at least partially aligned with a first sternocleidomastoid muscle of the wearer when the wearable device is worn; a second support member configured to be at least partially aligned with a second sternocleidomastoid muscle of the wearer when the wearable device is worn; an anterior connector configured to couple the first support member to the second support member and be positioned at least partially around an anterior side of the neck when the wearable device is worn; and a posterior connector configured to couple the first support member to the second support member and be positioned at least partially around a posterior side of the neck, opposite the anterior side, when the wearable device is worn.2. The wearable device of example 1 wherein, wherein the wearable device is worn, the first support member and the second support member are angled outwardly from outwardly from a mid-sagittal plane of the wearer.3. The wearable device of example 1 or 2 wherein: the wearable device defines a longitudinal axis and the anterior connector defines an anterior side of the wearable device, the first support member and the second support member each include an inferior end portion and a superior end portion, and when viewed from the anterior side, the inferior end portions of the first and second support members are positioned closer to the longitudinal axis than the superior end portions of the first and second support members.4. The wearable device of any of examples 1-3 wherein, when the wearable device is worn, the first support member and the second support member extend posteriorly and superiorly from the anterior connector.5. The wearable device of any of examples 1-4, further comprising a power transmission device configured to transmit power to a signal delivery device implanted within the wearer, wherein the power transmission device is coupled to the first support member or the second support member.6. The wearable device of any of examples 1-5, further comprising an electronics housing including a power source, coupled to the posterior connector, and configured to be positioned on the posterior side of the neck when the wearable device is worn.7. The wearable device of any of examples 1-6 wherein: the first support member is positionable to contact a first region of the wearer’s neck, the second support member is positionable to contact a second region of the wearer’ s neck, and in response to movement of the second region of the wearer’s neck relative to the first region of the wearer’s neck, the anterior connector and / or the posterior connector are configured to allow the second support member to move relative to the first support member to maintain the contact between (i) the first support member and the first region and (ii) the second support member and the second region.8. The wearable device of any of examples 1-7, further comprising a loop portion coupled to the first support member and the second support member, wherein the loop portion is configured to contact at least a portion of a jaw and / or chin of the wearer when the wearable device is worn.9. The wearable device of example 8 wherein, when the wearable device is worn: at least a portion of the posterior connector is configured to be placed in tension and draw the first and second support members posteriorly; and the contact between the loop portion and the wearer’s jaw and / or chin is configured to at least partially resist posterior movement of the first and second support members to substantially maintain a position of the wearable device about the wearer’ s neck.10. The wearable device of example 8 or 9 wherein the loop portion is flexible and configured to bend or deflect in response to movement of the wearer’s head and / or jaw.11. The wearable device of any of examples 8-10, further comprising a power transmission device configured to transmit power to a signal delivery device implanted within the wearer, wherein the power transmission device is coupled to the loop portion.12. The wearable device of any of examples 8-11, further comprising one or more sensors configured to receive data associated with the wearer, wherein the data includes a respiratory rate, a sleep state, a wake state, a heart rate, audio signals, body temperature, head orientation / position, movement of the wearer’s head relative to the neck, movement of the wearer’s neck relative to the head, saturated blood oxygen levels, air flow levels, thyroid movement, trachea movement, tongue movement, and / or photoplethysmography (PPG) data, and wherein the sensor is coupled to the loop portion.13. A wearable device operable to transmit power to one or more devices implanted within a wearer, the wearable device comprising: a first support member configured to be aligned with a first sternocleidomastoid muscle of the wearer when the wearable device is worn; a second support member configured to be aligned with a second sternocleidomastoid muscle of the wearer when the wearable device is worn;a loop portion coupled to the first support member and the second support member and configured to contact at least a portion of the wearer’s jaw and / or chin when the wearable device is worn; and a power transmission device carried by the first support member or the second support member, wherein, when the wearable device is worn, the power transmission device is positioned to transmit power to an implantable device implanted at least proximate to an ansa cervicalis nerve or a hypoglossal nerve of the wearer.14. The wearable device of example 13, further comprising: an anterior connector configured to couple the first support member to the second support member and be positioned at least partially around an anterior side of the wearer’s neck when the wearable device is worn; and a posterior connector configured to couple the first support member to the second support member and be positioned at least partially around a posterior side of the wearer’s neck, opposite the anterior side, when the wearable device is worn.15. The wearable device of example 13 or 14, further comprising an electronics housing configured to be positioned on a posterior side of the wearer’s neck when the wearable device is worn and operably coupled to the power transmission device to provide power thereto for transmission to the implantable device.16. The wearable device of any of examples 13-15, further comprising: one or more sensors coupled to the first support member, the second support member, and / or the loop portion, wherein the one or more sensors are configured to receive data associated with the wearer including a respiratory rate, a sleep state, a wake state, a heart rate, audio signals, body temperature, head orientation / position, neck, orientation / position, saturated blood oxygen levels, air flow levels, thyroid movement, trachea movement, tongue movement, and / or photoplethysmography (PPG) data.17. The wearable device of any of examples 13-16 wherein: the first support member and the second support member each include an inferior end portion and a superior end portion, andwhen the wearable device is worn — the first and second support members are configured to be positioned on opposite sides of a mid- sagittal plane of the wearer, and the inferior end portions of the first and second support members are positioned closer to the mid-sagittal plane than the superior end portions.18. A wearable device operable to receive data associated with a wearer’s sleep disordered breathing, the wearable device comprising: a first support member including a first elongate body extending between a first inferior end portion and a first superior end portion, the first support member configured to at least generally parallel to a first sternocleidomastoid muscle of the wearer when the wearable device is worn; a second support member including a second elongate body extending between a second inferior end portion and a second superior end portion, the second support member configured to at least generally parallel to a second sternocleidomastoid muscle of the wearer when the wearable device is worn; an anterior connector configured to couple the first inferior end portion of the first support member to the second inferior end portion of the second support member and be positioned at least partially around an anterior side of the wearer’s neck when the wearable device is worn; a posterior connector coupled to the first support member and the second support member between the inferior and superior end portions thereof and configured to be positioned at least partially around a posterior side of the wearer’s neck, opposite the anterior side, when the wearable device is worn; a loop portion coupled to the first superior end portion of the first support member and the second superior end portion of the second support member and configured to contact at least a portion of the wearer’s jaw and / or chin when the wearable device is worn; a blood oxygen sensor coupled to the first support member and configured to obtain an oxygen saturation of the wearer’s blood; an audio sensor coupled to the second support member and configured to obtain audio signals associated with the wearer’s respiration; andan electronics housing configured to be positioned on a posterior side of the neck when the wearable device is worn and operably coupled to the blood oxygen sensor and the audio sensor to provide power thereto and receive data therefrom, wherein, when the wearable device is worn, the first support member and / or the second support member extend posteriorly and superiorly from the anterior connector.19. The wearable device of example 18 wherein, when the wearable device is worn, the first support member is configured to be positioned within 20 degrees of being parallel to the first sternocleidomastoid muscle and the second support member is configured to be positioned within 20 degrees of being parallel to the second sternocleidomastoid muscle.20. The wearable device of example 18 or 19 wherein, when the wearable device is worn: at least a portion of the anterior connector is configured to be placed in tension and draw the inferior end portions of the first and second support members anteriorly; at least a portion of the posterior connector is configured to be placed in tension and draw the superior end portions of the first and second support members posteriorly; and the contact between the loop portion and the wearer’s jaw and / or chin is configured to at least partially resist anterior movement of the inferior end portions and posterior movement of the superior end portions to substantially maintain a position of the wearable device about the wearer’s neck.
[0066] It will be appreciated that specific embodiments of the disclosed technology have been described herein for purposes of illustration, but that various modifications may be made without deviating from the technology. For example, the signal delivery device can be leadless or can include a lead with one or more of the electrodes of the signal delivery device carried by the lead. Certain aspects of the technology described in the context of particular embodiments may be combined or eliminated in other embodiments. For example, two signal delivery devices can be implanted to bilaterally target tissues (e.g., left and right ansa cervicalis nerves) and / or to target different tissues on left and right sides of the wearer (e.g., a left ansa cervicalis nerve and a right infrahyoid strap muscle of the patient). Further, while advantages associated with certain embodiments of the disclosed technology have been described in the context of those embodiments, other embodiments may also exhibit such advantages, and not all embodiments need necessarily exhibit such advantages to fall within the scope of the technology.Accordingly, the disclosure and associated technology can encompass other embodiments not expressly shown or described herein.
[0067] Several stimulation targets are described and / or illustrated with reference to at least FIGS. 1 A, IB, 2B, and 2C. For the purpose of illustrative clarity, these stimulation targets and / or implantation techniques are shown with reference to a left and / or right side of the wearer’s anatomy, for example, a first or left ansa cervicalis nerve of the wearer W and / or a first or left one of the infrahyoid strap muscles. It will be appreciated, however, that at least some or all of the stimulation targets described and / or illustrated herein are equally suitable for application to the other side of the patient’s anatomy, for example, the second or right ansa cervicalis nerve of the wearer W and / or the second or right one of the infrahyoid strap muscles. Additionally, at least some of the stimulation targets and / or implantation techniques can be used for bilateral signal delivery, for example, to apply a first modulation signal to a first stimulation target on a first side of the wearer W at a first time, and to apply a second modulation signal to a second stimulation target on a side of the wearer W at the same or different time. The second modulation signal can be the same or different than the first modulation signal. In some embodiments, the first and second stimulation targets can be corresponding left and right portions of the wearer’s anatomy, such as the left and right ansa cervicalis nerves. In other embodiments, the first and second stimulation targets can be different, such as the left ansa cervicalis nerve and an infrahyoid strap muscle on a right side of the wearer. Additional details regarding placing signal delivery devices to deliver modulation signals to the hypoglossal nerve are described in U.S. Pub. No. 2024 / 0207613, filed December 21, 2023, the entirety of which is hereby incorporated by reference herein. Additional details regarding placing signal delivery devices to deliver modulation signals to the ansa cervicalis are described in U.S. Pub. No. 2024 / 0307384, filed March 15, 2024, the entirety of which is hereby incorporated by reference herein.
[0068] As used herein, the phrase “and / or,” as in “A” and / or “B” refers to A alone,B alone and both A and B. Unless otherwise stated, the terms "generally," "about," and "approximately" refer to values within 10% of a stated value. For example, the use of the term "about 100" refers to a range of 90 to 110, inclusive. In instances in which the context requires otherwise and / or relative terminology is used in reference to something that does not include a numerical value, the terms are given their ordinary meaning to one skilled in the art.
[0069] To the extent any materials incorporated herein by reference conflict with the present disclosure, the present disclosure controls.
Claims
CLAIMSI / We claim:
1. A wearable device configured to be worn at least partially around a neck of a wearer, the wearable device comprising: a first support member configured to be at least partially aligned with a first sternocleidomastoid muscle of the wearer when the wearable device is worn; a second support member configured to be at least partially aligned with a second sternocleidomastoid muscle of the wearer when the wearable device is worn; an anterior connector configured to couple the first support member to the second support member and be positioned at least partially around an anterior side of the neck when the wearable device is worn; and a posterior connector configured to couple the first support member to the second support member and be positioned at least partially around a posterior side of the neck, opposite the anterior side, when the wearable device is worn.
2. The wearable device of claim 1 wherein, wherein the wearable device is worn, the first support member and the second support member are angled outwardly from outwardly from a mid-sagittal plane of the wearer.
3. The wearable device of claim 1 wherein: the wearable device defines a longitudinal axis and the anterior connector defines an anterior side of the wearable device, the first support member and the second support member each include an inferior end portion and a superior end portion, and when viewed from the anterior side, the inferior end portions of the first and second support members are positioned closer to the longitudinal axis than the superior end portions of the first and second support members.
4. The wearable device of claim 1 wherein, when the wearable device is worn, the first support member and the second support member extend posteriorly and superiorly from the anterior connector.
5. The wearable device of claim 1, further comprising a power transmission device configured to transmit power to a signal delivery device implanted within the wearer, wherein the power transmission device is coupled to the first support member or the second support member.
6. The wearable device of claim 1, further comprising an electronics housing including a power source, coupled to the posterior connector, and configured to be positioned on the posterior side of the neck when the wearable device is worn.
7. The wearable device of claim 1 wherein: the first support member is positionable to contact a first region of the wearer’s neck, the second support member is positionable to contact a second region of the wearer’ s neck, and in response to movement of the second region of the wearer’s neck relative to the first region of the wearer’s neck, the anterior connector and / or the posterior connector are configured to allow the second support member to move relative to the first support member to maintain the contact between (i) the first support member and the first region and (ii) the second support member and the second region.
8. The wearable device of claim 1, further comprising a loop portion coupled to the first support member and the second support member, wherein the loop portion is configured to contact at least a portion of a jaw and / or chin of the wearer when the wearable device is worn.
9. The wearable device of claim 8 wherein, when the wearable device is worn: at least a portion of the posterior connector is configured to be placed in tension and draw the first and second support members posteriorly; and the contact between the loop portion and the wearer’s jaw and / or chin is configured to at least partially resist posterior movement of the first and second support members to substantially maintain a position of the wearable device about the wearer’ s neck.
10. The wearable device of claim 8 wherein the loop portion is flexible and configured to bend or deflect in response to movement of the wearer’s head and / or jaw.
11. The wearable device of claim 8, further comprising a power transmission device configured to transmit power to a signal delivery device implanted within the wearer, wherein the power transmission device is coupled to the loop portion.
12. The wearable device of claim 8, further comprising one or more sensors configured to receive data associated with the wearer, wherein the data includes a respiratory rate, a sleep state, a wake state, a heart rate, audio signals, body temperature, head orientation / position, movement of the wearer’s head relative to the neck, movement of the wearer’s neck relative to the head, saturated blood oxygen levels, air flow levels, thyroid movement, trachea movement, tongue movement, and / or photoplethysmography (PPG) data, and wherein the sensor is coupled to the loop portion.
13. A wearable device operable to transmit power to one or more devices implanted within a wearer, the wearable device comprising: a first support member configured to be aligned with a first sternocleidomastoid muscle of the wearer when the wearable device is worn; a second support member configured to be aligned with a second sternocleidomastoid muscle of the wearer when the wearable device is worn; a loop portion coupled to the first support member and the second support member and configured to contact at least a portion of the wearer’s jaw and / or chin when the wearable device is worn; and a power transmission device carried by the first support member or the second support member, wherein, when the wearable device is worn, the power transmission device is positioned to transmit power to an implantable device implanted at least proximate to an ansa cervicalis nerve or a hypoglossal nerve of the wearer.
14. The wearable device of claim 13, further comprising: an anterior connector configured to couple the first support member to the second support member and be positioned at least partially around an anterior side of the wearer’s neck when the wearable device is worn; and a posterior connector configured to couple the first support member to the second support member and be positioned at least partially around a posterior side of the wearer’s neck, opposite the anterior side, when the wearable device is worn.
15. The wearable device of claim 13, further comprising an electronics housing configured to be positioned on a posterior side of the wearer’s neck when the wearable device is worn and operably coupled to the power transmission device to provide power thereto for transmission to the implantable device.
16. The wearable device of claim 13, further comprising: one or more sensors coupled to the first support member, the second support member, and / or the loop portion, wherein the one or more sensors are configured to receive data associated with the wearer including a respiratory rate, a sleep state, a wake state, a heart rate, audio signals, body temperature, head orientation / position, neck, orientation / position, saturated blood oxygen levels, air flow levels, thyroid movement, trachea movement, tongue movement, and / or photoplethysmography (PPG) data.
17. The wearable device of claim 13 wherein: the first support member and the second support member each include an inferior end portion and a superior end portion, and when the wearable device is worn — the first and second support members are configured to be positioned on opposite sides of a mid- sagittal plane of the wearer, and the inferior end portions of the first and second support members are positioned closer to the mid-sagittal plane than the superior end portions.
18. A wearable device operable to receive data associated with a wearer’s sleep disordered breathing, the wearable device comprising: a first support member including a first elongate body extending between a first inferior end portion and a first superior end portion, the first support member configured to at least generally parallel to a first sternocleidomastoid muscle of the wearer when the wearable device is worn; a second support member including a second elongate body extending between a second inferior end portion and a second superior end portion, the second support member configured to at least generally parallel to a second sternocleidomastoid muscle of the wearer when the wearable device is worn;an anterior connector configured to couple the first inferior end portion of the first support member to the second inferior end portion of the second support member and be positioned at least partially around an anterior side of the wearer’s neck when the wearable device is worn; a posterior connector coupled to the first support member and the second support member between the inferior and superior end portions thereof and configured to be positioned at least partially around a posterior side of the wearer’s neck, opposite the anterior side, when the wearable device is worn; a loop portion coupled to the first superior end portion of the first support member and the second superior end portion of the second support member and configured to contact at least a portion of the wearer’s jaw and / or chin when the wearable device is worn; a blood oxygen sensor coupled to the first support member and configured to obtain an oxygen saturation of the wearer’s blood; an audio sensor coupled to the second support member and configured to obtain audio signals associated with the wearer’s respiration; and an electronics housing configured to be positioned on a posterior side of the neck when the wearable device is worn and operably coupled to the blood oxygen sensor and the audio sensor to provide power thereto and receive data therefrom, wherein, when the wearable device is worn, the first support member and / or the second support member extend posteriorly and superiorly from the anterior connector.
19. The wearable device of claim 18 wherein, when the wearable device is worn, the first support member is configured to be positioned within 20 degrees of being parallel to the first sternocleidomastoid muscle and the second support member is configured to be positioned within 20 degrees of being parallel to the second sternocleidomastoid muscle.
20. The wearable device of claim 18 wherein, when the wearable device is worn: at least a portion of the anterior connector is configured to be placed in tension and draw the inferior end portions of the first and second support members anteriorly; at least a portion of the posterior connector is configured to be placed in tension and draw the superior end portions of the first and second support members posteriorly; andthe contact between the loop portion and the wearer’s jaw and / or chin is configured to at least partially resist anterior movement of the inferior end portions and posterior movement of the superior end portions to substantially maintain a position of the wearable device about the wearer’s neck.
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