Methods for positioning signal delivery devices to treat sleep apnea, and associated devices and treatments

Implantable signal delivery devices targeting specific nerves and muscles provide a minimally invasive, personalized treatment for OSA by stabilizing or moving obstructive tissues, enhancing treatment efficacy and comfort.

WO2026006457A1PCT designated stage Publication Date: 2026-01-02INVICTA MEDICAL
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Patent Information

Application Number
PCT/US2025/035265
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Priority Date
2024-06-26
Filing Date
2025-06-25
Publication Date
2026-01-02

AI Technical Summary

Technical Problem

Existing treatments for obstructive sleep apnea (OSA), such as surgery and continuous positive airway pressure (CPAP) machines, are invasive or uncomfortable, and electrical stimulation techniques are not sufficiently efficacious, necessitating a minimally invasive and personalized treatment approach.

Method used

Implantable signal delivery devices positioned near target tissues, such as the ansa cervicalis nerve and hypoglossal nerve, deliver modulation signals to stabilize or move obstructive tissues, improving airway patency through wireless power and customizable treatment based on patient-specific tissue collapse patterns.

Benefits of technology

The approach minimizes invasiveness, enhances treatment efficacy by personalizing therapy to individual tissue collapse patterns, and improves airflow and comfort, reducing tissue collapse and sleep disruptions.

✦ Generated by Eureka AI based on patent content.

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Abstract

The present technology is generally directed to methods for addressing a patient's sleep apnea. In some embodiments, the method includes identifying one or more locations or sites at which the patient experiences tissue collapse, using the identified tissue collapse sites to select one or more target tissues associated with this tissue collapse, and positioning one or more signal delivery devices to deliver modulation signals to the one or more target tissues.
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Description

METHODS FOR POSITIONING SIGNAL DELIVERY DEVICES TO TREAT SLEEP APNEA, AND ASSOCIATED DEVICES AND TREATMENTSCROSS-REFERENCE TO RELATED APPLICATION

[0001] The present application claims priority to U.S. Provisional App. No. 63 / 664,408; filed June 26, 2024; the entirety of which is hereby incorporated by reference herein.TECHNICAL FIELD

[0002] The present technology is directed to methods for positioning signal delivery devices to treat sleep apnea, and associated devices and treatments.BACKGROUND

[0003] Obstructive sleep apnea (OSA) is a medical condition in which a patient’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 patient’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 patient’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, continuous positive airway pressure (CPAP) machines, and electrical stimulation of 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 patient’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 patient’s nose and mouth. However, these machines are uncomfortable, cumbersome, and may have low compliance rates.

[0006] Some electrical stimulation techniques seek to prevent the tongue from collapsing into the back of the pharynx by causing the tongue to protrude forward (e.g., in an anteriordirection) and / or flatten during sleep. However, many existing techniques for electrically stimulating the nerves of the patient’s oral cavity suffer from being too invasive and / or not sufficiently efficacious. Thus, there is a need for an improved minimally invasive treatment for OSA and other sleep disorders.BRIEF DESCRIPTION OF THE DRAWINGS

[0007] FIG. 1 A is a side sectional view depicting a patient's upper airway.

[0008] FIG. IB is a partially schematic illustration of representative neural structures and musculature of the patient's lower jaw and neck.

[0009] FIG. 2 is a block diagram illustrating elements of a system for treating breathing obstructions, including those caused by obstructive sleep apnea, in accordance with embodiments of the present technology.

[0010] FIG. 3 is a flow diagram of a method for treating a patient, in accordance with embodiments of the present technology.

[0011] FIGS. 4A-4C are side sectional views of a patient’s oral cavity and upper airway that depict representative tongue collapse patterns that can be identified and addressed via techniques in accordance with embodiments of the present technology.

[0012] FIG. 5 is a table of representative target tissues in accordance with embodiments of the present technology.

[0013] FIGS. 6A and 6B are tables listing representative target tissues based on patient tissue collapse location and type in accordance with embodiments of the present technology.

[0014] FIG. 7 is a table of representative target tissue modulation combinations in accordance with embodiments of the present technologies.10015] FIGS. 8-15B illustrate representative target tissues and implantation techniques in accordance with embodiments of the present technology.DETAILED DESCRIPTION

[0016] The present technology is discussed under the following headings for ease of readability:Heading 1 : “Introduction”Heading 2: “Overall Patient Physiology” (with a focus on FIGS. 1A and IB)Heading 3 : “System Overview” (with a focus on FIG. 2)Heading 4: “Treatment Method Overview” (with a focus of FIGS. 3-7)Heading 5 : “Representative Insertion Paths and Target Tissues” (with a focus on FIGS. 8-15B Heading 6: “Examples”

[0017] 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

[0018] Electrical modulation therapy for OSA typically includes delivering a modulation signal that modulates nerves and / or muscles, e.g., to cause the tongue and / or other soft tissue to move and / or to change the tissue tone (e.g., tighten or stiffen the tissue without muscular contraction or extension that induces movement). The electrical modulation 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 an effect on a nerve, a muscle, and / or other tissue that in turn has an effect on one or more motor functions (e.g., a breathing-related motor function).

[0019] 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 one or more target tissues of the patient’s upper airway, such as one or more nerves that innervate a muscle that can cause a change to and / or maintain a state of the patient’s airway and / or oral cavity. The signal delivery device can be implanted in a minimally invasive fashion, such as via a 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 patient's upper airway patency and / or improve the tone of the tissue of the intraoral cavity to treat OSA and / or other breathing obstructions. The external device can include one or more mouthpiece portions, collar portions, chinstrap portions, pillow portions, mattress overlay portions, and / or one or more other suitable wearable structures.

[0020] Representative target tissues include nerves such as the ansa cervicalis nerve and / or the hypoglossal nerve, which are located adjacent and / or around the oral cavity or in the neck. Stimulating the ansa cervicalis nerve can induce caudal traction (e.g., of the trachea), lower or depress the hyoid bone, 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 patient’s airway, thereby improving airflow through the upper airway and mitigating or even alleviating the breathing obstruction. For example, because the tongue is attached to the hyoid bone, lowering the hyoid bone can (i) draw the tongue downwardly / inferiorly and prevent, or at least partially prevent, the tongue and / or associated tissues from obstructing the patient’s airway, and / or (ii) improve airflow through the upper airway. Stimulating the hypoglossal nerve can cause the patient’s tongue to move anteriorly / forward and / or improve tissue tone to prevent the tongue and / or other soft tissues in the airway from collapsing onto the back of the patient’ s pharynx and / or into the upper airway. Such movement of potentially obstructive tissue in the upper airway / pharynx is expected to improve the patient’s sleep by mitigating or alleviating the obstruction. Further target tissues can include one or more muscles innervated by the hypoglossal nerve or the ansa cervicalis nerve (e.g., one or more of the patient’s infrahyoid strap muscles, including the sternohyoid muscles and / or the sternothyroid muscles); the glossopharyngeal nerve; the pharyngeal branches of the glossopharyngeal nerve; the pharyngeal plexus; the C2 and / or C3 spinal nerve; a lateral part of the epidural space at the Cl, C2, and / or C3 vertebral bodies; the pharyngeal branches of the glossopharyngeal nerve; one or more of the other target tissues described herein; and / or other suitable and / or therapeutically effective target tissues. Accordingly, the devices and associated methods disclosed herein can improve the patient's sleep by moving and / or stabilizing potentially obstructing tissue in various portions of the patient’s airway.

[0021] The one or more target tissues selected to receive modulation signals can be patientspecific. For example, embodiments of the present technology including identifying one or more locations or sites at which the patient experiences tissue collapse, using the identified tissue collapse sites to select one or more target tissues associated with this tissue collapse, and positioning one or more signal delivery devices to deliver modulation signals to the one or more target tissues. Accordingly, the present technology provides a customizable, highly-personalized approach to treating OSA and other breathing obstructions. By modulating select target tissues identified using the patient’s actual tissue collapse phenotype and / or endotype, the present technology is expected to provide improved patient outcomes (e.g., reduced or reversed tissue collapse, increased airflow, improved comfort and / or compliance) compared to other treatmentmodalities that rely on a generalized assessment of a patient’s motor response (e.g., tongue protrusion, nerve integrity monitoring, nanoendoscopy, etc.) to treat patients that present with a number of different tissue collapse etiologies. The patient’s tissue collapse phenotype refers to, e.g., one or more observable characteristics of and / or patterns associated with a breathing obstruction that may or may not relate to an underlying pathophysiological mechanism causing the breathing obstruction. The patient’s tissue collapse endotype refers to, e.g., a subtype or specific form of a breathing obstruction defined by a distinct pathophysiological mechanism.

[0022] Representative embodiments described herein include signal delivery devices having electrodes that can be positioned to deliver one or more electrical currents to one or more specific target locations, e.g., specific nerves and / or specific positions along a nerve. Such locations include locations along the patient's ansa cervicalis nerve, hypoglossal nerve, and / or vagus nerve. Additional locations include nerves that innervate muscles (e.g., palatal, oropharyngeal, laryngeal, omohyoid, sternohyoid, sternothyroid, thyrohyoid, nasal, lingual, pharyngeal, infrahyoid, diaphragmatic, and / or intercostal muscles) of the patient’s airway and / or portions thereof. 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.

[0023] Many embodiments of the technology described below may take the form of 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 distributed electronically 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 Patient Physiology

[0025] Representative embodiments described herein include implantable signal delivery devices having one or more electrodes that can be positioned to deliver one or more modulation signals to one or more specific target tissues, e.g., one or more nerves, one or more positions along a nerve, and / or one or more muscles. The target tissues can include one or more portions of the patient's ansa cervicalis nerve, hypoglossal nerve, vagus nerve, one or more nerves that innervate one or more muscles of the airway (e.g., palatal, oropharyngeal, laryngeal, omohyoid, sternohyoid, sternothyroid, thyrohyoid, nasal, lingual, pharyngeal, infrahyoid, diaphragmatic, and / or intercostal muscles), and / or any other nerves and / or muscles described and / or illustrated herein. The target tissue can be identified with respect to any of, or any combination of, a patient’s intrinsic and / or extrinsic muscles, associated nerve branches and / or portions thereof, and / or other physiological features. For example, some target tissues can be within the patient’s neck, such as at least proximate to the ansa cervicalis nerve, omohyoid muscle, sternohyoid muscle, sternothyroid muscle, and / or thyrohyoid muscle. Other target tissues can be located superior to the neck and / or within or at least proximate to the patient’s oral cavity, such as at least proximate to the hypoglossal nerve and / or at least proximate to and / or within the genioglossus muscle.

[0026] FIG. 1 A is a side section view depicting an upper airway of a patient P relative to a coordinate system in which the x-axis denotes the anterior-posterior directions, the y-axis denotes the superior-inferior and / or cranial-caudal directions, and the z-axis denotes the medial-lateral directions. The patient P 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, ananterior 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. The pharynx PHR includes the nasopharynx, the velopharynx, the oropharynx, and the laryngopharynx (each not labeled for simplicity). 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 patient's lower jaw and neck. The neural structures include the hypoglossal nerve HGN and the ansa cervicalis nerve AC. The hypoglossal nerve HGN innervates the genioglossus muscle GG. Specifically, the anterior branches of the hypoglossal nerve HGN, located anterior to a medial branch of the hypoglossal nerve HGN, innervate the genioglossus muscle GG at a motor point. The ansa cervicalis AC, and related branches emanating from the ansa cervicalis AC, enervate the omohyoid muscle OHM, the sternohyoid muscle SHM, and the sternothyroid muscle STM, collectively referred to as the infrahyoid or infrahyoid strap muscles. 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 patient's thyroid cartilage TH. The ansa cervicalis AC, and related branches emanating from the ansa cervicalis AC, enervate the omohyoid muscle OHM, the sternohyoid muscle SHM, and the sternothyroid muscle STM. Thestemothyroid muscle STM extends over (e.g., anterior to) the patient’s larynx L and between the sternum ST and the patient's thyroid cartilage TH. FIG. IB also illustrates the patient'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 patient’s larynx L. The muscles described above are contained within the patient's oral cavity OC, neck N, and / or shoulder SH. As described in greater detail below, by positioning and providing power to and / or otherwise activating one or more minimally invasive implantable signal delivery devices at least proximate to one or more the foregoing neural structures and / or associated musculature, embodiments of the present technology can control, reduce, and / or eliminate the effects of OSA and / or other breathing obstructions.3. System Overview

[0029] FIG. 2 is a block diagram illustrating elements of a system 200 for treating breathing obstructions, including those cause by obstructive sleep apnea, in accordance with embodiments of the present technology. The system 200 can include a wearable device 202, a charger 204, one or more implants or signal delivery devices (e.g., a first signal delivery device 206a, a second signal delivery device 206b . . . an nth signal delivery device 206n; referred to collectively as “signal delivery devices 206”) and a connected device or programmer 208. In general, the programmer 208 can transmit instructions for generating a modulation signal (e.g., signal delivery or waveform parameters) to the wearable device 202, the wearable device 202 can transmit the instructions and power to the signal delivery device(s) 206, and individual signal delivery devices 206 can generate the modulation signal according to the transmitted instructions and apply the modulation signal to a patient via electrodes carried by the signal delivery device(s) 206. One or more of the signal delivery devices 206 can be implanted in a patient using one or more of the insertion paths described below with reference to FIGS. 8-15B, in one or more of the positions and / or orientations described previously with reference to FIGS. 8-15B, and / or to deliver a modulation signal to one or more portions of the ansa cervicalis nerve, the hypoglossal nerve and / or one or more other target tissues described below with reference to FIGS. 5-15B.|0030] The programmer 208 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 patient. In a representative embodiment, the programmer 208 can include a therapy adjustment module configured to select one or more of the electrodes carriedby the signal delivery device(s) 206 and 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 208 can synthesize information (e.g., diagnostic and / or feedback information) received from a user, the wearable 202, and / or one or more of the signal delivery devices 206 and can adjust one or more of the signal delivery parameters based at least partially on the synthesized information. For example, the programmer 208 can be configured to (i) receive one or more inputs corresponding to a patient’s perception threshold and / or arousal threshold and (ii) adjust an amplitude of a modulation signal delivered to the patient based, at least in part, on the patient’s perception threshold and / or arousal threshold. Additionally, or alternatively, the programmer 208 can (i) generate a dose-response curve that plots Apnea- Hypopnea Index (AHI) against modulation amplitude and (ii) use the dose-response curve to adjust or recommend adjustments to the amplitude of the modulation signal delivered to the patient.[0031 | The programmer 208 can transmit the signal delivery parameters to the signal delivery device(s) 206 directly and / or via the wearable device 202. For example, the programmer 208 can be connected to individual ones of the signal delivery devices 206 and / or the wearable device 202 via a wired or wireless communication link, including WiFi, Bluetooth (“BT”), cellular connectivity, and / or any other suitable communication link. In these and other embodiments, the programmer 208 can be connected to a cloud 209 and / or other computer service to, e.g., upload data received from the wearable device’s 202 sensors and / or to download information to the wearable device 202 and / or the signal delivery device(s) 206. In these and other embodiments, the programmer 208 can include a display and / or a user interface. A user (e.g., the patient, the clinician, and / or other suitable user) can interact with and / or otherwise control one or more aspects of the programmer 208 via the user interface to, e.g., manually adjust one or more of the signal delivery parameters, to read data received from the wearable device 202 sensors, provide one or more inputs corresponding to a tissue collapse pattern, and / or carry out other tasks.10032] The wearable device 202 can include a collar, chinstrap, mouthpiece, pillow, and / or other suitable form factors. The wearable device 202 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 patient. Representative data received from the patient 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, and / or tonguemovement, and / or photoplethysmography (PPG) data. 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, heart rate data from a heart rate sensor, head orientation / position data from an accelerometer, etc.), and can correspond to a measure of the patient’s respiratory performance, sleep state, wake state, and / or other suitable metrics, for example, metrics that are used to rate the patient on the AHI. Additionally, or alternatively, the wearable device 202 can receive data from the individual signal delivery devices 206, e.g., using backscatter, pulse width modulation, frequency modulation, and / or one or more other suitable techniques. For example, the signal delivery devices 206 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 signal delivery device’s pulse generator, e.g., the transmitted signal and phase.|0033| The wearable device 202 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 signal delivery device(s) 206, and one or more algorithms configured to control one or more aspects of the operation of the wearable device 202. Individual ones of the sensors can collect data associated with the patient, such as a patient’s sleep state and / or respiratory performance. The one or more algorithms can be configured to adjust at least one of the signal delivery parameters based at least partially on the data collected by the sensors. In a representative embodiment, the wearable 202 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 patient based on the collected sleep state and / or respiratory performance data, e.g., via one of more algorithms.

[0034] In some embodiments, the wearable device 202 can further include a cover and / or housing, at least a portion of which may be removeable to, e.g., expose an interior or interior portion of the wearable device 202. In these and other embodiments, the wearable device 202 cover and / or housing can include fabric, or any other suitable material. Optionally, the wearable device 202 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 202, e.g., without using the programmer 208. 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 202, adjust one or more of the signal delivery parameters, configure and / or verify therapydelivery, select one or more therapy presets, confirm and / or verify placement of the wearable device, etc.

[0035] The charger 204 for the wearable device 202 can be configured to supply power to the wearable device’s 202 power source. The charger 204 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 204 can include an integrated controller and / or a connected device to, e.g., control the charging of the wearable device 202 and / or to upload / download data to the wearable device 202 while the wearable device 202 is charging.

[0036] The one or more signal delivery devices 206 can include an RFID component (e.g., a unique RFID tag that can be used to identify and / or locate the associated signal delivery device 206a-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 patient. 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 signal delivery devices 206 can receive, via the power receiving device and / or one or more other communication 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 patient via at least one of the electrodes of the signal delivery device(s) 206. The circuitry can include machine- readable instructions associated with the operation of the signal delivery device(s) 206. 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 signal delivery device 206 to the wearable device 202. For example, the signal delivery device 206 can transmit information to the wearable device 202 associated with one or more of the signal delivery parameters of the modulation signal being applied to the patient. In these and other embodiments, one or more of the signal delivery devices 206 can include a hermetic package or housing configured such that the signal delivery device(s) 206 can be implanted within a patient.

[0037] In some embodiments, one or more of the signal delivery devices 206 are passive devices that do not include an onboard pulse generator configured to generate modulation signals. Instead, the passive signal delivery device can wirelessly receive a power signal from the wearable device 202 and transmit the received power signal to the wearer via the electrodes. The passive signal delivery device may condition or otherwise process the received power signal but not, e.g., use the received power signal to power an onboard pulse generator and / or store the receive power for use long-term and / or in the absence of externally-supplied power.

[0038] In some embodiments, all or a subset of the signal delivery devices 206 are coupled to a common or shared implantable pulse generator (IPG). For example, one or more of the signal delivery devices 206 can include a lead and all or a subset of those leads can be coupled to the IPG. The IPG can be implanted within the patient, such as within a pocket below the clavicle and / or anterior to a pectoral muscle, and the leads can be percutaneously injected at least proximate to one or more of the target tissues described herein and operably connected to the IPG (e.g., via tunneling).

[0039] Each of the signal delivery devices 206 can be configured to deliver modulation signals having the same or one or more different signal delivery parameters (e.g. amplitude, frequency, pulse width) to, e.g., optimize the patient’s airflow response or efficacy for each respective target location. For example, individual ones of the signal delivery parameters can be determined based, at least in part, on the patient’s measured airway flow response or another physiologic input from an external wearable or another device configured to detect the patient’s airway flow response. Additionally, or alternatively, one or more signal delivery parameters of the modulation signals delivered by each of the signal delivery devices 206 can vary based, at least in part, on the respective locations and / or target tissues of each signal delivery device 206.

[0040] In some embodiments, one or more of the signal delivery parameters of the modulation signal delivery by each signal delivery device 206 can be adjusted or modulated during delivery in, e.g., a closed loop or an open loop manner. For example, the adjustments / modulations to the signal delivery parameters can compensate for movement of each signal delivery device 206 relative to their respective target locations after implantation, which can be caused by movement of the patient and / or one or more changes in a patient’s body position. Additionally, the adjustments / modulations to the signal delivery parameters can compensate for one or more changes in the patient’s sleep stage, data associated with an efficacy of the modulation therapy (e.g., air flow, respiratory effort), etc.

[0041] In some embodiments, each signal delivery device 206 can be activated independently, such that a subset of the one or more signal delivery devices 206 can be active while others of the signal delivery devices 206 are inactive. Each signal delivery device 206 can alternate between active / on and inactive / off states independently for selected periods, such as very short durations (e.g., 100 msec) or longer durations (e.g., 10 seconds). For example, in some embodiments, an ON-OFF modulation pattern can be programmed to regularly alternate between the signal delivery devices 206a. For example, the first signal delivery device 206a can be ON (e.g., receiving power and / or delivering modulation signals) for a first time period (e.g., at least 1 second, 2 seconds, 3 seconds, 4 seconds, 5 seconds, etc.), followed by the second signal delivery device 206b being ON for a second time period (e.g., at least 1 second, 2 seconds, 3 seconds, 4 seconds, 5 seconds, etc.). In some embodiments, the first time period and / or the second time period can be randomly selected. In some embodiments, the first signal delivery device 206a can be OFF (e.g., not receiving power and / or not delivering modulation signals) when the second signal delivery device 206b is ON and / or vice versa, and / or delivery of the modulation signals can be concurrent for a portion of the modulation pattern. In other embodiments, both the first and second signal delivery devices 206a, 206b can be ON and OFF at the same, or at least generally the same, times. In further embodiments, the times during which a given signal delivery device 206 is ON or OFF can be randomized. In some embodiments, after at least one of the signal delivery devices 206 has completed an ON interval, that signal delivery device 206 can remain OFF for an OFF interval. The OFF interval can be up to 1 minute, 2 minutes, 3 minutes, 4 minutes, 5 minutes, 10 minutes, etc. The OFF interval can also vary over time, can be randomly selected, and / or include one or more other suitable durations of time.

[0042] In some embodiments, individual electrodes carried by each signal delivery device 206 can be activated or deactivated to direct delivery of the modulation signal toward the respective target location and / or to adjust the electrical field generated to deliver the modulation signal (e.g., narrow or widen the electrical field). For example, if the signal delivery devices 206 include quadripolar electrodes arrays having four electrodes, using the middle two (e.g., second and third) electrodes can create a field that is narrower than, e.g., using the outer two (e.g., first and fourth) electrodes.

[0043] In some embodiments, a cyclic modulation pattern can be programmed to regularly alternate one or more parameters of the signals delivered by the signal delivery devices 206. The amplitude, pulse width, and / or frequency can be programmed to be changed regularly at programmed time intervals, in response to sensed data, randomly, irregularly, etc. The cyclicmodulation pattern can include, for example, 1.0 mA for 1 second, then 2.0 mA for 1 second, and then 1.0 mA for 1 second for a duration of 3 seconds of modulation. Another example cyclic modulation pattern includes 0.5 mA for 1 second, then 1.0 mA for 1 second, and then 0.5 mA for 1 second for a duration of 3 seconds of modulation. Each of the signal delivery devices 206 can deliver their respective modulation signals at the same or different times as one or more other signal delivery devices 206, and / or the modulation signals can be delivered concurrently for a portion of the modulation pattern.

[0044] In some embodiments, an if-then modulation pattern can be programmed to respond to one or more specific physiologic measurements (e.g., air flow) detected or determined by, e.g., one or more sensors of the signal delivery device, one or more sensors implanted within the patient, and / or a wearable or other external sensing device. For example, the wearable 202 can turn ON at least one of the signal delivery devices 206. If the patient’s physiologic response is insufficient, as determined based at least in part on the one or more physiological measurements, the wearable 202 can turn on one or more other signal delivery devices 206 so that the ON signal delivery devices are operating simultaneously. Additionally, or alternatively, one or more parameters of the respective signals delivered by the signal delivery devices 206 can be adjusted (e.g., as described herein) in response one or more of the physiological measurements.

[0045] In some embodiments, the signal delivery devices 206 can be programmed with phase manipulation patterns. For example, the amplitude of the modulation signal delivered by the signal delivery devices 206 can ramp up and down during a modulation interval in a sine wave shape. In some embodiments, the modulation signal delivered by one of the signal delivery devices 206 can have a phasing pattern in phase or 180 degrees out of phase with the modulation signal delivery by one or more of the other signal delivery devices 206. In at least some embodiments, two or more signal delivery devices 206 can be programmed to create a phase inversion via delivery of their respective modulation signals. In some embodiments, the modulation signal can be a square wave and can be ramped in a stepwise fashion, e.g., from a first pulse to a second pulse.4. Treatment Method Overview

[0046] FIG. 3 is a flow diagram of a method 310 for addressing breathing obstructions in a patient in accordance with embodiments of the present technology. In some embodiments, the method 310 is used to treat OSA and / or one or more other breathing obstructions by (i) stiffening one or more tissues associated with the tissue collapse and / or (i) reducing or reversing the tissuecollapse causing the patient’s OSA and / or other breathing obstruction(s). The method 310 can be performed with or by any of the systems and / or devices described herein, such as the system 200 of FIG. 2 and / or one or more of the components thereof (e.g., the wearable 202, the implantable devices 206, the programmer 208). In some embodiments, some or all of the blocks of the method 310 are performed by a system or device including one or more processors and a memory storing instructions that, when executed by the one or more processors, cause the system or device to perform one or more of the blocks described herein. For example, all or a subset of the method 310 can be performed by a first processor of the wearable 202, a second processor of the programmer 208, and / or another suitable processor. Optionally, some or all of the blocks of the method 310 can performed automatically or semi-automatically, with little or no human intervention. In other embodiments, at least a subset of the method 310 can be performed by a physician, a practitioner, or other user.|0047| At block 312, the method 310 can include identifying one or more tissue collapse sites of a patient. Identifying the one or more tissue collapse sites can include endotyping the patient’s OSA or other breathing obstruction, e.g., to identify one or more locations within the patient at which tissue collapse may cause or contribute to the patient’s OSA or other breathing obstruction. The one or more tissue collapse sites can include one or more locations in and / or portions of a patient’s nasopharyngeal, oropharyngeal, and / or laryngopharyngeal airways. Example tissue collapse sites include (i) a retrolingual portion of the oropharyngeal airway and / or (ii) a retropharyngeal portion of the oropharyngeal airway.

[0048] In some embodiments, the one or more tissue collapse sites can identified based at least in part on data from one or more diagnostics or tests administered to the patient. These data can include (i) drug induced sleep endoscopy (DISE) results; (ii) airway pressure measurements, such as via a multi-site pressure catheter; (iii) optical coherence topography (OCT) imaging, e.g., of the patient’s retina; (iv) polysomnography (PSG) endotyping (e.g., including lung volume and / or loop gain); (v) dynamic sleep imaging, e.g., including computed tomography (CT), magnetic resonance imaging (MRI), and / or ultrasound scans; (vi) one or more awake surrogates, such as upper airway collapsibility index (UACI); (vii) spirometry results, including lung volume measurements or other breathing data; and / or (viii) data from other suitable diagnostics or tests. Additionally, or alternatively, the one or more tissue collapse sites can identified based at least in part on one or more anatomic risk factors or other predictors associated with the patient’s physiology. The one or more anatomic risk factors or other predictors can include (i) the patient’s neck circumference; (ii) the patient’s palate size and / or shape (e.g., Woodson classification); (iii)Mallampati score, Friedman Tongue Position, Mueller maneuver test results, and / or combinations thereof; (iv) tongue size, (v) tongue position, and / or (vi) other patient phenotyping. In these and / or other embodiments, the one or more tissue collapse sites can be identified based at least in part on one or more non-invasive detection techniques, such as one or more phenotypic measurements, ultrasound-based detection, sound-based detection, electrically-based detection, and / or vibrationbased detection.

[0049] At block 314, the method 310 can include identifying a tissue collapse type for each of the identified tissue collapse sites (block 312). For example, identifying the tissue collapse type can include identifying or categorizing the way in which the patient’s OSA or other breathing obstruction presents. The tissue collapse type can include and / or be identified using (i) one or more tissue collapse vectors or other directional indicators; such as anterior-posterior (A / P), laterolateral (L / L), or concentric such as complete concentric collapse (CCC); (ii) a tissue collapse frequency, such as the percentage of impacted breaths over a predetermined time period (e.g., up to 1 minute, 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 180 minutes, 240 minutes, 360 minutes, 480 minutes, 600 minutes, and / or combinations thereof); (iii) a tissue collapse severity, such as the average percent flow decrease per impacted breath; and / or (iv) a metric, referred to hereinafter as “SCORE”, correlating the tissue collapse frequency to the tissue collapse severity over time. The SCORE metric can, for example, be the product of the tissue collapse frequency and the tissue collapse severity. The tissue collapse vectors can be determined using DISE and / or other suitable techniques.

[0050] In some embodiments, the identified tissue collapse type (block 314) can be based at least in part on one or more sleep variables, such as the patient’s sleeping position (e.g., supine, prone, right lateral recumbent, left lateral recumbents, fowler position, semi-fowler position, trendelenburg position), sleep stage (e.g., awake, non-rapid eye movement (NREM), or rapid eye movement (REM)), and / or one or more changes to the sleep variables during a given sleep period (of, e.g., up to 8 hours, 9 hours, 10 hours, 12 hours, and / or combinations thereof) and / or between individual sleep periods. For example, the patient can exhibit different types and / or magnitudes of tissue collapse in different sleeping positions and / or during different sleep stages, and identifying the tissue collapse type can include identifying how the patient’s tissue collapse type and / or magnitude varies during and / or between different sleeping positions and / or sleep stages. At least some or all of the above-noted sleep variables can also affect the tissue collapse site (block 312) and accordingly, in at least some embodiments, block 312 can include identifying one ormore tissue collapse sites based at least in part on all or a subset of these and / or other sleep variables.

[0051] At block 316, the method 310 can include, for each of the identified tissue collapse types (block 314), selecting one or more target tissues associated with the tissue collapse type. In some embodiments, block 316 can include selecting one or more target tissues that, when modulated, are expected to produce a motor response in the patient that at least partially counteract reduce, or prevent the specific tissue collapse present in the patient. For example, if the tissue collapse type (block 314) includes latero-lateral L / L collapse in the nasopharyngeal airway, block 316 can include selecting one or more nerves and / or muscles associated with the nasopharyngeal airway that, when modulated, widen / open and / or stiffen the nasopharyngeal airway and / or other reduce or reverse tissue collapse within the nasopharyngeal airway.

[0052] In some embodiments, in addition to or instead of reducing or reversing the tissue collapse, modulating the target tissue can increase the stiffness of the target tissue to thereby improve the tone of the associated airway and, e.g., increase airflow and / or reduce the likelihood of further tissue collapse at that location. Selecting the one or more target tissues can include identifying the one or more target tissues for tissue collapse types associated with a SCORE (block 314) that equals or exceeds a predetermined threshold. For example, if the SCORE for a given tissue collapse type exceeds a threshold (e.g., greater than 200, 300, 400, 500, 600, 700, 800, 900, etc.), then selecting the one or more target tissues can include selecting one or more targets tissues that are associated with and / or otherwise expected to address that tissue collapse type.

[0053] Example target tissues include one or more muscles associated with the patient’s (i) nose, such as the nasalis muscle and / or the levator labii superioris alaeque; (ii) tongue, such as the genioglossus; (iii) pharynx, such as the palatopharyngeus, stylopharyngeus, and / or pharyngeal constrictors; (iv) neck and / or lower jaw, such as the anterior and / or posterior digastric muscles, geniohyoid muscle, omohyoid muscle, thyrohyoid muscle, sternohyoid muscle, posterior cricoarytenoid muscle, and / or cricothyroid muscle; and / or (v) thorax, such as the diaphragm and / or external intercostal muscles. In some embodiments, the target tissues can include a nerve innervating one or more of the above-noted muscles. For example, the target tissues can include the patient’s VII nerve, XII nerve, X nerve, XI nerve, V nerve, Cl nerve, ansa cervicalis nerve, phrenic nerve, and / or one or more intercostal nerves (at, e.g., one or more of vertebral levels Tl- Tl l).

[0054] In some embodiments, block 316 includes selecting multiple target tissues that are expected to produce different but synergistic or complimentary responses. For example, the ansa cervicalis nerve (which, when modulated, contracts the sternothyroid and / or sternohyoid to thereby induce caudal traction and / or pharyngeal wall stiffening) and the hypoglossal nerve (which, when modulated, contracts the genioglossus muscle to thereby contract the tongue’s base and dilate the patient’s retrolingual airway) are complementary target tissues because both improve airflow when modulated but do so by addressing different (e.g., retropharyngeal and retrolingual) portions of the patient’s airway. Both the ansa cervicalis and the hypoglossal nerve are associated with the patient’s oropharyngeal airway. Accordingly, when the tissue collapse type (block 314) is associated with tissue collapse in the oropharyngeal airway, block 316 can include selecting the hypoglossal nerve and the ansa cervicalis nerve, and / or one or more of the muscles innervated by these nerves.|0055[ In some embodiments, selecting the one or more target tissues includes selecting multiple target tissues expected to cause the same, or an at least related, patient response. For example, when modulated, each of the omohyoid, thyrohyoid, sternohyoid, and sternothyroid muscles are expected to cause caudal traction. In some instances, such as when modulating one of these muscles in isolation does not produce a full caudal traction response, modulating two or more of these muscles is expected to produce a greater or enhanced effect and, e.g., produce a full caudal traction response. Accordingly, if modulating a given target tissue produces a motor response of a first magnitude that is less than a patient response threshold, selecting the one or more target tissues can include selecting one or more other target tissues that, when modulated, produce the motor response (or an at least generally similar motor response) of a second magnitude equal to or greater than the patient response threshold and / or that otherwise addresses tissue collapse in a same or substantially similar portion of the patient’s airway.

[0056] At block 318, the method 310 can include, for each of the identified target tissues (block 316), positioning a signal delivery device at least proximate to the identified target tissue. Positioning the signal delivery device at least proximate to the identified target tissue can include positioning the signal delivery device a distance of from about 15mm to about 0.01mm from the target tissue, such as within up to 14mm, 13mm, 12mm, 11mm, 10mm, 9mm, 8mm, 7mm, 6mm, 5mm, 4mm, 3mm, 2mm, 1mm, or 0.1mm from target tissue, within any distance therebetween, or within another suitable distance from the target tissue. In some embodiments, positioning the signal delivery device at least proximate to the identified target tissue includes positioning the signal delivery device in contact with and / or at least partially within the target tissue. The signaldelivery device, which can be at least generally similar or identical to one or more of the implantable devices 206 (FIG. 2), can include an electrically-activatable needle, a lead, an implantable device including a lead, a leadless implantable device, and / or one or more other suitable signal delivery devices.

[0057] In some embodiments, the signal delivery device is configured to be implanted in the patient percutaneously (via, e.g., a delivery catheter, a percutaneous injection needle, a pre- loaded delivery syringe, and / or otherwise without a tissue dissection), and positioning the signal delivery device includes percutaneously implanting or injecting the signal delivery device at least proximate to the target tissue. Positioning the signal delivery device can include moving the signal delivery device toward the target tissue and along an insertion path. The insertion path can vary based on the location of the target tissue. Representative target tissues and insertion paths are described below with reference to FIGS. 8-15B. Additional details regarding target tissues and insertion paths can be found in U.S. Pub. No. 2024 / 0207613, filed December 21, 2023, and U.S. Pat. No. 12,246,175, filed March 15, 2024, both of which are hereby incorporated by reference herein in their entireties.

[0058] At block 320, the method 310 can include, for each signal delivery device (block 318), delivering one or more modulation signals to the identified target tissue via the signal delivery device. In some embodiments, delivering the one or more modulation signals includes delivering one or more modulation signals to each of the identified target tissues in series (to e.g., a first target tissue, then a second target tissue, then a third target tissue, etc.). In other embodiments, delivering the one or more modulation signals includes delivering one or more modulation signals to all or a subset of the identified target tissues at a same time (to, e.g., a first and a second target tissue at a same time, the second and a third target tissue at a same time, the first through the third target tissues at a same time, etc.). If the delivered modulation signals do not produce a satisfactory response, the method 310 can include (i) adjusting one or more of the parameters for delivering the modulation signal (e.g., amplitude, frequency, pulse width, duty cycle, etc.) and / or (ii) identifying one or more additional and / or other target tissues expected to address the same type of tissue collapse and delivering one or more modulation signals to the additional and / or other target tissues until, e.g., the modulation signals delivered to the patient produce a satisfactory response. Whether a patient’s response is satisfactory can be determined on a per-patient basis based at least in part on the target tissue, the tissue collapse site, and / or the severity of the patient’s breathing obstruction. In some embodiments, a satisfactory response can improve the patient’s airflow by at least 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, or100%. Additionally, or alternatively, a satisfactory response can include a motor response that reduces or entirely reverses the tissue collapse experienced by the patient.

[0059] FIGS. 4A-4C are side sectional views of a patient’s oral cavity and upper airway and depict representative tissue collapse patterns that can be identified and addressed via techniques in accordance with embodiments of the present technology. More specifically, FIG. 4A illustrates upper tongue collapse in the retropalatal portion RP of the patient’s airway, with the tongue T pressing against the patient’s soft palate (e.g., shown using dashed line). FIG. 4B illustrates lower tongue collapse in a retrolingual portion RL of the patient’s airway. FIG. 4C illustrates combined (e.g., full) tongue collapse in both the retropalatal portion RP and the retrolingual portion RL of the patient’s airway. These and other tissue collapse can be identified using the techniques described previously herein with reference to blocks 312 and / or 314 of the method 310 (FIG. 3).

[0060] FIG. 5 is a table of representative target tissues in accordance with embodiments of the present technology. As shown in the table, the target tissues can include one or more muscles and / or one or more of the nerves innervating those muscles. The target tissues included in the table are grouped based on the portion of the patient’s airway that they influence and are listed with a corresponding motor response and expected effect on the patient’s airway. The table also identifies whether the target tissues are inspiratory. Inspiratory muscles activate in conjunction with and / or as a function of patient inhalation and assist with filling the lungs and / or keeping the airway open. Because many instances of upper airway collapse occur during inhalation, modulating one or more inspiratory muscles is expected to address the upper airway collapse when it occurs. At least some inspiratory muscles are also expiratory in nature. Expiratory muscles contract during exhalation and assist with emptying the lungs. Thus, in many instances, expiratory muscles do not provide tone or patency to the upper airway (positive pressure from the lungs during expiration may provide tone or patency to the upper airway). The inspiratory column has been left blank for muscles that have not been confirmed as inspiratory.

[0061] In some embodiments, one or more of the target tissues can be selected (as in, e.g., block 316) based at least in part on the one or more tissue collapse sites (block 312) and / or the tissue collapse type (block 314) for each of the tissue collapse sites. For example, for tissue collapse in the patient’s nasal airway (e.g., nasopharyngeal tissue collapse), the selected target tissues can include the alar part of the nasalis muscle, the medial part of the levator labii superioris alaeque, and / or one or more of the associated nerves that, when modulated, are expected to dilate the patient’s nasal airway and, e.g., reduce or reverse nasopharyngeal tissue collapse. As anotherexample, for tissue collapse in a retrolingual portion of the patient’s oropharyngeal airway, the selected target tissues can include the genioglossus muscle, one or more of the pharyngeal constrictor muscles, the anterior and / or posterior digastric muscles, the geniohyoid muscle, the posterior cricoarytenoid muscle, the cricothyroid muscle, and / or one or more of the associated nerves that, when modulated, are expected to produce a motor response that increases airflow through and / or stabilizes the retrolingual portion of the patient’s airway to, e.g., reduce or reverse the patient’s retrolingual tissue collapse. As a further example, for tissue collapse in a retropharyngeal portion of the patient’s oropharyngeal airway, the selected target tissues can include the palatopharyngeus muscle, the stylopharyngeus muscle, one or more of the pharyngeal constrictor muscles, the omohyoid muscle, the thyrohyoid muscle, the sternohyoid muscle, the sternothyroid muscle, the diaphragm, one or more of the external intercostal muscles, and / or one or more of the associated nerves that, when modulated, are expected to produce a motor response that increases airflow through and / or stabilizes the retropharyngeal portion of the patient’s airway to, e.g., reduce or reverse the patient’s retropharyngeal tissue collapse.|0062] The table in FIG. 5 also includes a representative ranking for each of the listed target tissues. These rankings were generated based on the presumption that the patient already receives modulation targeting the hypoglossal nerve and the ansa cervicalis nerve (and / or one or more of the muscles innervated by these nerves), to reflect the expected improvement these other targets are expected to provide. In practice, target tissues that receive modulation signals can be selected as described previously with reference to the method 310 of FIG. 3, with or without taking into consideration the representative rankings in the table in FIG. 5.|0063| FIGS. 6A and 6B are tables listing representative target tissues based on patient tissue collapse location and type in accordance with embodiments of the present technology. The patient’s tissue collapse location can be identified as described previously with reference to block 312. In the illustrated tables, the tissue collapse locations include a general obstruction area (e.g., nasal, retropharyngeal, retrolingual, laryngeal, and mixed or centra apnea), a collapse location (e.g., nares, palate, oropharynx, tongue base, epiglottis, vocal cord, and lung), and a collapse sublocation (e.g., upper / velar or lower / uvular palate collapse, upper or lower oropharynx collapse, upper or lower tongue base collapse, blade or other epiglottis collapse) that further specifies the location of the patient’s tissue collapse. The collapse sub-locations listed in the table are portions or regions of the associated collapse location.

[0064] The tables also illustrate various tissue collapse types, including collapse vectors, collapse frequencies, and collapse severities, that can be obtained as described previously with reference to block 314. These data can be used to generate a SCORE for each tissue collapse location and each SCORE can be compared to identify possible target tissues. For example, the table includes data from a patient, indicating that the patient has (i) anterior-posterior A / P collapse at the lower oropharynx that impacts 50% of the patient’s breaths (i.e., frequency = 50) and decreases airflow by an average of 30% per impacted breath (i.e., severity = 30), (ii) anterior- posterior A / P collapse at the upper tongue base that impacts 80% of the patient’s breaths (i.e., frequency = 80) and decreases airflow by an average of 100% per impacted breath (i.e., severity = 100), (iii) latero-lateral L / L collapse at the upper oropharynx that impacts 10% of the patient’s breaths (i.e., frequency = 10) and decreases airflow by an average of 100% per impacted breath (i.e., severity = 100), and (iv) anterior-posterior A / P collapse at the lower tongue base that impacts 80% of the patient’s breaths (i.e., frequency = 80) and decreases airflow by an average of 100% per impacted breath (i.e., severity = 100). Given these data, the patient’s SCOREs indicate that anterior-posterior A / P tissue collapse at the upper and lower tongue base are the main contributor to the patient’s breathing obstruction. The hypoglossal nerve HGN and / or the genioglossus muscle GG (including, e.g., the oblique genioglossus muscle fibers GGo and / or the horizontal genioglossus muscle fibers GGh) are target tissues that, when modulated, can address anterior- posterior A / P tissue collapse at the upper and lower tongue base. Accordingly, to address the patient’s tissue collapse, a practitioner can implant a signal delivery device to modulate the patient’s hypoglossal nerve HGN (which innervates the genioglossus muscle GG) and / or one or both of the oblique genioglossus muscle fibers GGo and the horizontal genioglossus muscle fibers GGh. The table also lists secondary and tertiary target tissues (i.e., Target2 and Target3, respectively) that can be modulated in addition to or instead the primary target tissue (i.e., Targetl). For example, for a given tissue collapse location, modulating both the primary and secondary target tissue is expected to provide a greater or enhanced effect compared to modulating only one of the primary or second target tissues. This enhanced effect may not be needed when, e.g., modulating the primary target tissue alone sufficiently reduces or reverses the patient’s tissue collapse or otherwise restores their airflow.

[0065] The tables illustrated in FIGS. 6A and 6B list a number of different tissue collapse locations, sub-locations, a vectors and provides primary, secondary, and in some cases tertiary target tissues for each of the tissue collapse locations, sub-locations, and vectors. A person of ordinary skill in the art will appreciate that the above-discussion of the representative patient datashown in FIGS. 6A and 6B provide one example of how data regarding a patient’s tissue collapse can be used to identify and / or modulate target tissue to address the patient’s tissue collapse. Accordingly, in these and / or other embodiments, any of the other target tissues listed in the tables or otherwise described herein can be identified and / or modulated based at least in part on data regarding a given patient’s tissue collapse.(0066] FIG. 7 is a table of representative target tissue modulation combinations in accordance with embodiments of the present technologies. As shown in the table, modulation signals can be delivered to various combinations of the target tissues described herein. Merged cells in the table indicate that either or both target tissue can be modulated. Brackets (e.g., “[x]”) indicate that the target tissue can be modulated on a per-patient basis in response to, e.g., the patient’s specific tissue collapse type. The table lists various representative 2-, 3-, and 4-target combinations. The 2-target combinations are expected to produce results that are at least generally similar or identical to modulating the patient’s hypoglossal nerve HGN and ansa cervicalis nerve AC. For example, the 2-target combinations include (i) the hypoglossal nerve (or genioglossus muscle) which, when modulated, moves the patient’s tongue to reduce or reverse tissue collapse in a retrolingual portion RL of the patient’ s airway and (ii) another target associated with either a retropharyngeal portion RP of the patient’s airway or a nasal portion NS of the patient’s airway, depending on the patient’s specific tissue collapse sites (block 312). The 3-target combinations shown are the same as the 2-target combinations, but further include one of the diaphragm (or phrenic nerve) or the external intercostal muscles (or intercostal nerves) which, when modulated, improve the patient’s long volume. The 4-target combinations shown are the same as the 2-target combinations, but further include (i) one or more first target tissues associated with the patient’s nasal airway NS and (ii) one or more second target tissues associated with the retrolingual portion RL of the patient’s airway which, when modulated, address tissue collapse caused by the patient’s epiglottis. Each of the above-noted approaches can be modified on a per- patient basis based at least in part on a given patient’s tissue collapse location (block 312) and / or tissue collapse type (block 314). For example, a given patient can only receive modulation to address tissue collapse at the locations identified for that patient, and other target tissues can omitted unless / until the patient develops tissue collapse at locations associated with the other target tissues.5. Representative Insertion Paths and Target Tissues|0067| Several target tissues and implantation techniques are described and / or illustrated with reference to FIGS. 8-15B. For the purpose of illustrative clarity, these target tissues and implantation techniques are shown with reference to a left or right side of the patient anatomy. It will be appreciated, however, that all or a subset of the target tissues and / or implantation techniques described and / or illustrated with reference to FIGS. 8-15B are equally suitable for application to the other side of the patient’s anatomy. Additionally, at least some of the target tissues and / or implantation techniques can be used for bilateral signal delivery, for example, to apply a first electrical signal to a first target tissue on a first side of the patient and to apply a second electrical signal to a second target tissue on a side of the patient P at a same or different time. The second electrical signal can be the same or different from the first electrical signal. In some embodiments, the first and second target tissues can be corresponding left and right portions of the patient’s anatomy, such as first and second portions of the left and right hypoglossal nerves. In other embodiments, the first and second target tissues can be different, such as a portion of the ansa cervicalis nerve on a left side of the patient and a portion of the hypoglossal nerve on a right side of the patient. Moreover, although each of FIGS. 8-15B show one or more signal delivery devices 206 (i) in a specific orientation and (ii) positioned at least proximate to one or more specific target tissues, those of ordinary skill in the art will understand that one or more of the signal delivery devices 206 can be position in other orientations and / or at least proximate to other target tissues, in addition to or instead of those illustrated in FIGS. 8-15B. Furthermore, although the various target tissues and implantation techniques of the present technology may be described with reference to a specific figure, those of ordinary skill in the art will appreciate that any one or more target tissues described with reference to a given figure can be targeted for modulation in combination with any one or more other target tissues described with reference to the same figure and / or one or more other figures, including any of the combinations described previously with reference to FIG. 7.(0068] FIG. 8 is a side section view of a portion of the patient’s neck and lower jaw anatomy, including the ansa cervicalis AC, the omohyoid muscle OHM, the sternohyoid muscle SHM, the sternothyroid muscle STM, and the thyrohyoid muscle THM. FIG. 8 additionally illustrates the patient’s hypoglossal nerve HGN, including the medial branch MB of the hypoglossal nerve HGN and the anterior branches AB of the hypoglossal nerve HGN. The anterior branches AB include the distal arborizing portions of the HGN, such as the motor points, motor end plates, and / or neuromuscular junctions of the HGN that insert into the genioglossus GG. In some patients, oneor more of the anterior branches AB include a plurality of distal brachiated portions or distal branches DB that innervate the patient’s genioglossus muscle GG. By positioning and activating minimally invasive electrodes positioned proximate to the foregoing neural structures and / or associated musculature, embodiments of the present technology can control, reduce, and / or eliminate the effects of OSA.

[0069] FIG. 8 also illustrates first and second signal delivery devices 206a, 206b positioned in accordance with embodiments of the present technology. The first and second signal delivery devices 206a, 206b can be implanted as part of a same procedure, or one of the first and second signal delivery devices 206a, 206b can be implanted sometime after the other of the first and second signal delivery devices 206a, 206b has been implanted. The first signal delivery device 206a can be positioned to deliver modulation signals to a first target tissue and the second signal delivery device 206b can be positioned to deliver modulation signals to a second target tissue, different from the first target tissue. For example, in the illustrated embodiment, the first signal delivery device 206a is positioned to deliver one or more first modulation signals to the anterior branches AB of the patient’s hypoglossal nerve HGN and the second signal delivery device 206b is positioned to deliver one or more second modulation signals to a branch of the ansa cervicalis AC that innervates the omohyoid muscle OHM and sternohyoid muscle SHM. These target tissues can be selected as described previously with reference to FIGS. 3-7. In some embodiments, the first signal delivery device 206a is implanted after the second signal delivery device 206b based at least in part on a determination that ansa cervicalis AC modulation alone is insufficient to address the patient’s breathing obstructions. In other embodiments, the second signal delivery device 206b is implanted after the first signal delivery device 206a based at least in part on a determination that hypoglossal nerve HGN modulation alone is insufficient to address the patient’s breathing obstructions. The signal delivery devices 206a, 206b can be positioned within the patient P using respective insertion paths 830a, 830b, although those of ordinary skill in the art will appreciate that one or both of the signal delivery devices 206a, 206b can be positioned in other orientations and / or using other insertions paths to modulate the target tissues. Additional details regarding signal delivery device insertion paths and orientations can be found in U.S. Pub. No. 2024 / 0207613, filed December 21, 2023, and U.S. Pat. No. 12,246,175, filed March 15, 2024, each of which is hereby incorporated by reference herein in its entirety.

[0070] The first signal delivery device 206a and / or the second signal delivery device 206b can be positioned to modulate other target tissues selected as described previously with reference to FIGS. 3-7. For example, the first signal delivery device 206a can be positioned to deliver thefirst modulation signals to any one or more of: the medial branch MB of the hypoglossal nerve HGN, the genioglossus muscle GG directly, the inferior root IR of the ansa cervicalis AC, the superior root SR of the ansa cervicalis AC, one or more of the branches of the ansa cervicalis AC, one or more of the motor points of the ansa cervicalis AC, the omohyoid muscle OHM, the sternohyoid muscle SHM, the sternothyroid muscle STM, the thyrohyoid muscle THM, or other target tissues described herein to address the patient’s OSA. Additionally, or alternatively, the second signal delivery device 206b can be positioned to deliver the second electricals signals to any one or more of: the medial branch MB of the hypoglossal nerve HGN, one or more of the anterior branches AB of the hypoglossal nerve HGN, the genioglossus muscle GG directly, the inferior root IR of the ansa cervicalis AC, the superior root SR of the ansa cervicalis AC, one or more of the branches of the ansa cervicalis AC, one or more of the motor points of the ansa cervicalis AC, the omohyoid muscle OHM, the sternohyoid muscle SHM, the sternothyroid muscle STM, and / or the thyrohyoid muscle THM, or another target location described herein to address the patient’s OSA. In these and / or other embodiments, the first and second signal delivery devices 206a, 206b can be positioned to bilaterally stimulate respective tissues on the left and right side of the patient, e.g., the left hypoglossal nerve and the right ansa cervicalis nerve, the left thyrohyoid muscle and the right genioglossus muscle, etc.[00711 FIG. 9 is a perspective view of the patient’s cephalic anatomy, including facial nerve CN VII, an alar part of the nasalis muscle ANM, and the levator labii superioris alaque nasi LLSAN. One or more signal delivery devices can be positioned to deliver modulation signals to these target tissues. For example, FIG. 9 illustrates the first signal delivery device 206a positioned to modulate the facial nerve CN VII, the second signal delivery device 206b positioned to modulate the alar part of the nasalis muscle ANM, and the third signal delivery device 206c positioned to modulate a medial portion of the levator labii superioris alaque nasi LLSAN. In other embodiments, one or more of the signal delivery devices 206a-c can be omitted. The signal delivery devices 206a-c can be positioned within the patient P in the orientation depicted in FIG. 9 using a respective insertion path 930a-c. The first insertion path 930a can extend distally, superiorly, and / or laterally relative to a midline of the patient and can be spaced laterally from the patient’s nose so as to facilitate positioning the first signal delivery device 206a across or transverse to the facial nerve CN VII and / or one or more anterior branches thereof. The second insertion path 930b can extend distally and / or superiorly along the nares so as to facilitate positioning the second signal delivery device 206b across or at least generally transverse to one or more fibers of the alar part of the nasalis muscle ANM. The third insertion path 930c can extenddistally, inferiorly, and / or laterally relative to a midline of the patient and along a bridge of the patient’s nose so as to facilitate positioning the third signal delivery device 206c across or at least generally transverse to one or more fibers of the medial portion of the levator labii superioris alaque nasi LLSAN. Additionally, those of ordinary skill in the art will appreciate that, to modulate the illustrated and / or other target tissues, one or more of the signal delivery devices 206a-c can be positioned in orientations and / or using insertions paths other than those shown in FIG. 9.

[0072] FIG. 10 is a perspective view showing the patient’s vagus nerve CN X pharyngeal constrictors PC, including a superior pharyngeal constrictor SPC, a medial pharyngeal constrictor MPC, and an inferior pharyngeal constrictor IPC. One or more signal delivery devices can be positioned to deliver modulation signals to one or more of these target tissues. For example, FIG. 10 illustrates the first signal delivery device 206a positioned to modulate the superior pharyngeal constrictor SPC, the second signal delivery device 206b positioned to modulate the medial pharyngeal constrictor MPC, and the third signal delivery device 206c positioned to modulate the inferior pharyngeal constrictor IPC. In other embodiments, one or more of the signal delivery devices 206a-c can be omitted and / or one or more other signal delivery devices can be positioned to modulate the pharyngeal constrictors PC via the vagus nerve CN X and / or one or more of the motor points thereof. The signal delivery devices 206a-c can be positioned within the patient P in the orientation depicted in FIG. 10 using a respective insertion path 1030a-c, e.g., the second signal delivery device 206b below / inferior to the first signal delivery device 206a and the third signal delivery device 206c below / inferior to the second signal delivery device 206b. The first insertion path 1030a can extend distally, superiorly, and / or medially (e.g., toward the patient’s midline) so as to facilitate positioning the first signal delivery device 206a distally from the patient’s mandible and across or at least partially transverse to one or more fibers of the superior pharyngeal constrictor SPC. The second insertion path 1030b can extend distally, superiorly, and / or medially (e.g., toward the patient’s midline) so as to facilitate positioning the second signal delivery device 206b distally from and / or inferior to the patient’s mandible and across or at least partially transverse to one or more fibers of the medial pharyngeal constrictor MPC. The third insertion path 1030c can extend distally, superiorly, and / or medially (e.g., toward the patient’s midline) so as to facilitate positioning the third signal delivery device 206c below the patient’s mandible and across or at least partially transverse to one or more fibers of the inferior pharyngeal constrictor IPC. Additionally, those of ordinary skill in the art will appreciate that, to modulatethe illustrated and / or other target tissues, one or more of the signal delivery devices 206a-c can be positioned in orientations and / or using insertions paths other than those shown in FIG. 10.

[0073] FIG. 11 is a side section view showing the patient’s glossopharyngeal nerve CN IX and stylopharyngeus muscle SPM. The superior, medial, and interior pharyngeal constrictors SPC, MPC, IPC are also shown for context. One or more signal delivery devices can be positioned to deliver modulation signals to one or more of these target tissues. For example, FIG. 11 illustrates the first signal delivery device 206a positioned to modulate the stylopharyngeus muscle SPM directly. In other embodiments, the first signal delivery device 206a or another signal delivery device can be positioned to modulate the stylopharyngeus muscle SPM via the patient’s glossopharyngeal nerve CN IX, at least a portion of which can extend along the length of the stylopharyngeus muscle SPM. The first signal delivery device 206a can be positioned within the patient P in the orientation depicted in FIG. 11 using an insertion path 1130. The insertion path 1130 can extend distally and / or superiorly so as to facilitate positioning the first signal delivery device 206a along and / or at least generally parallel to the stylopharyngeus muscle SPM. Additionally, those of ordinary skill in the art will appreciate that, to modulate the illustrated and / or other target tissues, the first signal delivery device 206a and / or one or more other signal delivery devices can be positioned in orientations and / or using insertions paths other than those shown in FIG. 11.

[0074] FIG. 12A is a perspective view showing the patient’s larynx L, superior laryngeal nerve SLN including the inferior branch IB and the exterior branch EB thereof, recurrent laryngeal nerve RCN, and cricothyroid muscle CTM. The inferior pharyngeal constrictor IPC is also shown for context. One or more signal delivery devices can be positioned to deliver modulation signals to one or more of these target tissues. For example, FIG. 12A illustrates the first signal delivery device 206a positioned to modulate the cricothyroid muscle CTM via the exterior branch EB of the superior laryngeal nerve SLN and the second signal delivery device 206b positioned to modulate the recurrent laryngeal nerve RLN. In other embodiments, one or more of the signal delivery devices 206a, 206b can be omitted and / or one or more other signal delivery devices can be positioned to modulate the cricothyroid muscle CTM directly. The signal delivery devices 206a, 206b can be positioned within the patient P in the orientation depicted in FIG. 12A using a respective insertion path 1230a, 1230b. The first insertion path 1230a can extend distally, superiorly, superior to the trachea TR, and / or laterally relative to a midline of the patient so as to facilitate positioning the first signal delivery device 206a at least proximate and / or at least generally parallel to the exterior branch EB of the superior laryngeal nerve SLN. The secondinsertion path 1230b can extend anteriorly and / or superiorly so as to facilitate positioning the first signal delivery device 206a distally from the trachea TR and / or inferior to the larynx L and at least proximate and / or at least generally parallel to the recurrent laryngeal nerve RLN. Additionally, those of ordinary skill in the art will appreciate that, to modulate the illustrated and / or other target tissues, one or more of the signal delivery devices 206a, 206b and / or one or more other signal delivery devices can be positioned in orientations and / or using insertions paths other than those shown in FIG. 12 A.

[0075] FIG. 12B is a perspective view showing the patient’s larynx L with the inferior pharyngeal constrictor IPC (FIG. 12 A) omitted to better show the recurrent laryngeal nerve RCN innervating the patient’s posterior cricoarytenoid muscle PCM. One or more signal delivery devices can be positioned to deliver modulation signals to one or more of these target tissues. For example, FIG. 12B illustrates the third signal delivery device 206c positioned to modulate the posterior cricoarytenoid muscle PCM. In other embodiments, the third signal delivery device 206c can be omitted and / or one or more other signal delivery devices can be positioned to modulate the posterior cricoarytenoid muscle PCM via the recurrent laryngeal nerve RCN, such as shown in FIG. 12 A. The third signal delivery device 206c can be positioned within the patient P in the orientation depicted in FIG. 12C using insertion path 1230c, which can extend distally, laterally relative to a midline of the patient, and / or superior to the trachea TR so as to facilitate positioning the third signal delivery device 206c across or at least generally transverse to the recurrent laryngeal nerve RCN. Additionally, those of ordinary skill in the art will appreciate that, to modulate the illustrated and / or other target tissues, the third signal delivery device 206c and / or one or more other signal delivery devices can be positioned in orientations and / or using insertions paths other than those shown in FIG. 12B.

[0076] FIG. 13 is a side section view showing the patient’s palatopharyngeal muscle PPM and pharyngeal branch PB of the vagus nerve. One or more signal delivery devices can be positioned to deliver modulation signals to this target tissue. For example, FIG. 13 illustrates the first signal delivery device 206a positioned to modulate the palatopharyngeal muscle PPM directly. In other embodiments, the first signal delivery device 206a and / or one or more other signal delivery devices can be positioned to modulate the palatopharyngeal muscle PPM via the pharyngeal branch PB of the vagus nerve. The first signal delivery device 206a can be positioned within the patient P in the orientation depicted in FIG. 13 using an insertion path 1330a, which can extend distally and / or through the patient’s oral cavity OC. Additionally, those of ordinary skill in the art will appreciate that, to modulate the illustrated and / or other target tissues, the firstsignal delivery device 206a and / or one or more other signal delivery devices can be positioned in orientations and / or using insertions paths other than those shown in FIG. 13.

[0077] FIG. 14 is a perspective view showing the patient’s phrenic nerve PN. One or more signal delivery devices can be positioned to deliver modulation signals to this target tissue. For example, FIG. 14 illustrates four signal delivery devices 206a-d positioned at various portions / branches along the phrenic nerve PN to modulate the phrenic nerve PN. Each of the signal delivery devices 206a-d can be positioned within the patient P in the orientation depicted in FIG. 14 (e.g., across or at least generally transverse to the phrenic nerve PN) using a respective insertion path 1430a-d. The first insertion path 1430a can extend medially (e.g., toward the patient’s midline and / or sternum ST) and anterior or posterior to the clavicle CL. The second, third, and / or fourth insertion paths 1430b-d can extend medially (e.g., toward the patient’ s midline and / or sternum ST) and / or run inferior to the clavicle CL. Additionally, those of ordinary skill in the art will appreciate that, to modulate the illustrated and / or other target tissues, one or more of the signal delivery devices 206a-d and / or one or more other signal delivery devices can be positioned in orientations and / or using insertions paths other than those shown in FIG. 14.

[0078] FIG. 15 A is a perspective view showing an anterior perspective view of the patient’ s intercostal nerves ICN. One or more signal delivery devices can be positioned to deliver modulation signals to one or more of the intercostal nerves ICN. For example, FIG. 15A illustrates the three signal delivery devices 206a-c positioned to modulate respective branches of the intercostal nerves ICN. Each of the signal delivery devices 206a-c can be positioned within the patient P in the orientation depicted in FIG. 15A (e.g., across or at least generally transverse to one or more branches of the intercostal nerves ICN) using a respective insertion path 1530a-c. One or more of the insertion paths 1530a-c can extend inferiorly, anteriorly, at least partially between a pair of (e.g., a pair of adjacent) rib bones R, and / or anterior to the patient’s clavicle CL and / or shoulder SH. Additionally, those of ordinary skill in the art will appreciate that, to modulate the illustrated and / or other target tissues, one or more of the signal delivery devices 206a-c and / or one or more other signal delivery devices can be positioned in orientations and / or using insertions paths other than those shown in FIG. 15 A.

[0079] FIG. 15B is a perspective view showing a posterior perspective view of the patient’ s intercostal muscles ICM. One or more signal delivery devices can be positioned to deliver modulation signals to one or more of the intercostal muscles ICM. For example, FIG. 15B illustrates the three signal delivery devices 206d-f positioned to modulate respective intercostalmuscles ICM. Each of the signal delivery devices 206d-f can be positioned within the patient P in the orientation depicted in FIG. 15B (e.g., at least generally transverse to one or more fibers of the intercostal muscles ICM) using a respective insertion path 153Od-f. One or more of the insertion paths 153Od-f can extend inferiorly, anteriorly, at least partially between a pair of (e.g., a pair of adjacent) rib bones R, and / or anterior or posterior to the intercostal muscles ICM and / or rib cage. Additionally, those of ordinary skill in the art will appreciate that, to modulate the illustrated and / or other target tissues, one or more of the signal delivery devices 206d-e and / or one or more other signal delivery devices can be positioned in orientations and / or using insertions paths other than those shown in FIG. 15B.

[0080] Accordingly, in some aspects of the present technology, a practitioner or other user can position one or more signal delivery devices to deliver modulation signals to one or more patient-specific target tissues identified based at least in part on the patient’s specific tissue phenotype and / or endotype. For example, embodiments of the present technology include identifying one or more locations or sites at which the patient experiences tissue collapse, using the identified tissue collapse sites to select one or more target tissues associated with this tissue collapse, and positioning one or more signal delivery devices to deliver modulation signals to the one or more target tissues. Accordingly, the present technology provides a customizable, highly- personalized approach to treating OSA and other breathing obstructions that is expected to provide improved patient outcomes (e.g., reduced or reversed tissue collapse, increased airflow, improved comfort and / or compliance) compared to other treatment modalities that rely on a generalized motor response (e.g., tongue protrusion) to treat patients that present with a number of different tissue collapse etiologies.6. Examples

[0081] The following examples provide further embodiments of the present technology:1. A method of addressing a breathing obstruction in an airway of a patient, the method comprising: obtaining data characterizing the breathing obstruction; identifying, based on the data, a tissue collapse site in the airway and associated with the breathing obstruction; determining, based on the data, a type of tissue collapse at the tissue collapse site;selecting, based on the tissue collapse site and the type of tissue collapse, a target tissue to receive a modulation signal to at least partially address the breathing obstruction; and causing a signal delivery device to deliver the modulation signal to the target tissue to at least partially address the breathing obstruction.2. The method of example 1 wherein the target tissue is a first target tissue, wherein the modulation signal is a first modulation signal, wherein the signal delivery device is a first signal delivery device, and wherein the method further comprises: determining that the delivery of the first modulation signal partially addressed the breathing obstruction; selecting a second target tissue, different from the first target tissue, to receive a second modulation signal, different from the first modulation signal, wherein the second target tissue is selected to produce a second motor response when modulated that is different from but complimentary to a first motor response produced by the first target tissue; and causing a second signal delivery device to deliver the second modulation signal to the second target tissue to further address the breathing obstruction.3. The method of example 1 or example 2 wherein the target tissue is a first target tissue, wherein the modulation signal is a first modulation signal, wherein the signal delivery device is a first signal delivery device, and wherein the method further comprises: determining that a motor response caused by the delivery of the first modulation signal partially addressed the breathing obstruction; selecting a second target tissue, different from the first target tissue, to receive a second modulation signal, different from the first modulation signal, wherein the second target tissue is selected to aid the first target tissue in causing the motor response when modulated; and causing a second signal delivery device to deliver the second modulation signal to the second target tissue to further address the breathing obstruction.4. The method of any of examples 1-3 wherein identifying the tissue collapse site include identifying a first portion of the patient’s airway associated with the breathing obstruction,wherein the target tissue is a first target tissue selected to at least partially address tissue collapse in the first portion of the airway, wherein the modulation signal is a first modulation signal, wherein the signal delivery device is a first signal delivery device, and wherein the method further comprises: identifying a second portion of the patient’s airway associated with the breathing obstruction; and selecting a second target tissue, different from the first target tissue, to receive a second modulation signal from a second signal delivery device to at least partially address tissue collapse in the second portion of the airway.5. The method of any of examples 1-4 wherein determining the type of tissue collapse includes determining a percentage of impacted breaths over a predetermined time period and / or an average percent flow decrease per impacted breath.6. The method of any of examples 1-5 wherein determining the type of tissue collapse includes determining a vector of the tissue collapse.7. The method of any of examples 1-6 wherein determining the type of tissue collapse includes: identifying a number of candidate tissue collapse types; for each of the number of candidate tissue collapse types — calculating a product of a frequency of the candidate tissue collapse type and a severity of the candidate tissue collapse type, and determining whether the product is equal to or exceeds a predetermined threshold; and when the product for a given one of the candidate tissue collapse types is equal to or exceeds a predetermined threshold, determining the given one of the candidate tissue collapse types is the type of tissue collapse.8. One or more non-transitory, computer-readable media having instructions that, when executed by one or more processors of a patient treatment system, cause the patient treatment system to: obtain data characterizing a breathing obstruction in an airway of a patient;determine, based on the data, a tissue collapse site in the airway and associated with the breathing obstruction; identify, based on the data, a type of tissue collapse at the tissue collapse site; select, based on the tissue collapse site and the type of tissue collapse, a target tissue to receive a modulation signal to at least partially address the breathing obstruction; and cause a signal delivery device of the patient treatment system to deliver the modulation signal to the target tissue to at least partially address the breathing obstruction.9. The one or more non-transitory, computer-readable media of example 8 wherein the target tissue is a first target tissue, wherein the modulation signal is a first modulation signal, wherein the signal delivery device is a first signal delivery device, and wherein the instructions further cause the patient treatment system to: determine that the delivery of the first modulation signal partially addressed the breathing obstruction; select a second target tissue, different from the first target tissue, to receive a second modulation signal, different from the first modulation signal, wherein the second target tissue is selected to produce a second motor response when modulated that is different from but complimentary to a first motor response produced by the first target tissue; and cause a second signal delivery device to deliver the second modulation signal to the second target tissue to further address the breathing obstruction.10. The one or more non-transitory, computer-readable media of example 8 or example 9 wherein the target tissue is a first target tissue, wherein the modulation signal is a first modulation signal, wherein the signal delivery device is a first signal delivery device, and wherein the instructions further cause the patient treatment system to: determine that a motor response caused by the delivery of the first modulation signal partially addressed the breathing obstruction; select a second target tissue, different from the first target tissue, to receive a second modulation signal, different from the first modulation signal, wherein the second target tissue is selected to aid the first target tissue in causing the motor response when modulated; andcause a second signal delivery device to deliver the second modulation signal to the second target tissue to further address the breathing obstruction.11. The one or more non-transitory, computer-readable media of any of examples 8-10 wherein the target tissue is a first target tissue, wherein the modulation signal is a first modulation signal, wherein the signal delivery device is a first signal delivery device, and wherein the instructions further cause the patient treatment system to: determine that a motor response caused by the delivery of the first modulation signal partially addressed the breathing obstruction; select a second target tissue, different from the first target tissue, to receive a second modulation signal, different from the first modulation signal, wherein the second target tissue is selected to aid the first target tissue in causing the motor response when modulated; and cause a second signal delivery device to deliver the second modulation signal to the second target tissue to further address the breathing obstruction.12. The one or more non-transitory, computer-readable media of any of examples 8-11 wherein the tissue collapse site include a first portion of the patient’s airway associated with the breathing obstruction, wherein the target tissue is a first target tissue selected to at least partially address tissue collapse in the first portion of the airway, wherein the modulation signal is a first modulation signal, wherein the signal delivery device is a first signal delivery device, and wherein the instructions further cause the patient treatment system to: identifying a second portion of the patient’s airway associated with the breathing obstruction; and selecting a second target tissue, different from the first target tissue, to receive a second modulation signal from a second signal delivery device to at least partially address tissue collapse in the second portion of the airway.13. The one or more non-transitory, computer-readable media of any of examples 8-12 wherein the instructions that cause the patient treatment system to determine the type of tissue collapse include instructions that cause the patient treatment system to: identify a number of candidate tissue collapse types; for each of the number of candidate tissue collapse types —calculate a product of a frequency of the candidate tissue collapse type and a severity of the candidate tissue collapse type, and determine whether the product is equal to or exceeds a predetermined threshold; and when the product for a given one of the candidate tissue collapse types is equal to or exceeds a predetermined threshold, determine the given one of the candidate tissue collapse types is the type of tissue collapse.14. The one or more non-transitory, computer-readable media of any of examples 8- 13 wherein the instructions that cause the signal delivery device to deliver the modulation signal include instructions that cause a wearable device of the patient treatment system to wirelessly transmit power to the signal delivery device.15. A system for addressing a breathing obstruction in an airway of a patient, the system comprising: one or more processors configured to — obtain data characterizing a breathing obstruction in a patient; determine, based on the data, a tissue collapse site in the airway and associated with the breathing obstruction; identify, based on the data, a type of tissue collapse at the tissue collapse site; and select, based on the tissue collapse site and the type of tissue collapse, a target tissue to receive a modulation signal to at least partially address the breathing obstruction; and a signal delivery device configured to be positioned at least proximate to the target tissue to deliver the modulation signal to the target tissue and thereby at least partially address the breathing obstruction.16. The system of example 15 the type of tissue collapse includes a phenotype of the tissue collapse, and wherein the phenotype is based at least in part on a percentage of impacted breaths over a predetermined time period and / or an average percent flow decrease per impacted breath. re17. The system of example 15 or example 16wherein the type of tissue collapse includes an endotype of the tissue collapse, and wherein the endotype is based at least in part on a vector of the tissue collapse.18. The system of any of examples 15-17 wherein the one or more processors are configured to select the target tissue based at least in part on a predetermined ranking of candidate target tissue expected to at least partially address the breathing obstruction.19. The system of any of examples 15-18 wherein the one or more processors are configured to select the target tissue based on an assumption that the patient has received at least two other signal delivery devices positioned to modulate a hypoglossal nerve of the patient and an ansa cervicalis nerve of the patient, respectively.20. The system of any of examples 15-19 wherein the data includes imaging data and / or airway pressure measurements.

[0082] 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 include a lead, and one or more of the electrodes of the signal delivery device can be 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 the patient’s tissues (e.g., left and right ansa cervicalis nerves) and / or to target different tissues on left and right sides of the patient (e.g., a left ansa cervicalis nerve and a right hypoglossal nerve 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.

[0083] Several stimulation targets are described and / or illustrated with reference to at least FIGS. 1A, IB, and 5-15B. For the purpose of illustrative clarity, these stimulation targets are shown with reference to a left or right side of the patient P’s anatomy, for example, a first or left ansa cervicalis nerve of the patient P and / or a first or left one of the infrahyoid strap muscles. Itwill be appreciated, however, that at least some or all of the stimulation targets and / or implantation techniques described and / or illustrated with reference to at least FIGS. 1A, IB, and 5-15B 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 patient P 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 target tissue on a first side of the patient P at a first time, and to apply a second modulation signal to a second target tissue on a second side of the patient P at the same or different time. The second modulation signal can be the same as or different from the first modulation signal. In some embodiments, the first and second target tissues can be corresponding left and right portions of the patient’s anatomy, such as first and second portions of the left and right ansa cervicalis nerves, respectively. In other embodiments, the first and second target tissues can be different, such as the left ansa cervicalis nerve and an infrahyoid strap muscle on a right side of the patient. Additional details regarding placing signal delivery devices to deliver modulation signals to the hypoglossal nerve are described in U.S. Pub. No. 2024 / 0207613, the entirety of which is incorporated by reference herein. Additional details regarding placing signal delivery devices to deliver modulation signals to the ansa cervicalis are described in U.S. Pat. No. 12,246,175, filed March 15, 2024, the entirety of which is incorporated by reference herein.

[0084] 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 where 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.

[0085] To the extent any materials incorporated herein by reference conflict with the present disclosure, the present disclosure controls.

Claims

CLAIMSI / We claim:

1. A method of addressing a breathing obstruction in an airway of a patient, the method comprising: obtaining data characterizing the breathing obstruction; identifying, based on the data, a tissue collapse site in the airway and associated with the breathing obstruction; determining, based on the data, a type of tissue collapse at the tissue collapse site; selecting, based on the tissue collapse site and the type of tissue collapse, a target tissue to receive a modulation signal to at least partially address the breathing obstruction; and causing a signal delivery device to deliver the modulation signal to the target tissue to at least partially address the breathing obstruction.

2. The method of claim 1 wherein the target tissue is a first target tissue, wherein the modulation signal is a first modulation signal, wherein the signal delivery device is a first signal delivery device, and wherein the method further comprises: determining that the delivery of the first modulation signal partially addressed the breathing obstruction; selecting a second target tissue, different from the first target tissue, to receive a second modulation signal, different from the first modulation signal, wherein the second target tissue is selected to produce a second motor response when modulated that is different from but complimentary to a first motor response produced by the first target tissue; and causing a second signal delivery device to deliver the second modulation signal to the second target tissue to further address the breathing obstruction.

3. The method of claim 1 wherein the target tissue is a first target tissue, wherein the modulation signal is a first modulation signal, wherein the signal delivery device is a first signal delivery device, and wherein the method further comprises:determining that a motor response caused by the delivery of the first modulation signal partially addressed the breathing obstruction; selecting a second target tissue, different from the first target tissue, to receive a second modulation signal, different from the first modulation signal, wherein the second target tissue is selected to aid the first target tissue in causing the motor response when modulated; and causing a second signal delivery device to deliver the second modulation signal to the second target tissue to further address the breathing obstruction.

4. The method of claim 1 wherein identifying the tissue collapse site include identifying a first portion of the patient’s airway associated with the breathing obstruction, wherein the target tissue is a first target tissue selected to at least partially address tissue collapse in the first portion of the airway, wherein the modulation signal is a first modulation signal, wherein the signal delivery device is a first signal delivery device, and wherein the method further comprises: identifying a second portion of the patient’s airway associated with the breathing obstruction; and selecting a second target tissue, different from the first target tissue, to receive a second modulation signal from a second signal delivery device to at least partially address tissue collapse in the second portion of the airway.

5. The method of claim 1 wherein determining the type of tissue collapse includes determining a percentage of impacted breaths over a predetermined time period and / or an average percent flow decrease per impacted breath.

6. The method of claim 1 wherein determining the type of tissue collapse includes determining a vector of the tissue collapse.

7. The method of claim 1 wherein determining the type of tissue collapse includes: identifying a number of candidate tissue collapse types; for each of the number of candidate tissue collapse types — calculating a product of a frequency of the candidate tissue collapse type and a severity of the candidate tissue collapse type, anddetermining whether the product is equal to or exceeds a predetermined threshold; and when the product for a given one of the candidate tissue collapse types is equal to or exceeds a predetermined threshold, determining the given one of the candidate tissue collapse types is the type of tissue collapse.

8. One or more non-transitory, computer-readable media having instructions that, when executed by one or more processors of a patient treatment system, cause the patient treatment system to: obtain data characterizing a breathing obstruction in an airway of a patient; determine, based on the data, a tissue collapse site in the airway and associated with the breathing obstruction; identify, based on the data, a type of tissue collapse at the tissue collapse site; select, based on the tissue collapse site and the type of tissue collapse, a target tissue to receive a modulation signal to at least partially address the breathing obstruction; and cause a signal delivery device of the patient treatment system to deliver the modulation signal to the target tissue to at least partially address the breathing obstruction.

9. The one or more non-transitory, computer-readable media of claim 8 wherein the target tissue is a first target tissue, wherein the modulation signal is a first modulation signal, wherein the signal delivery device is a first signal delivery device, and wherein the instructions further cause the patient treatment system to: determine that the delivery of the first modulation signal partially addressed the breathing obstruction; select a second target tissue, different from the first target tissue, to receive a second modulation signal, different from the first modulation signal, wherein the second target tissue is selected to produce a second motor response when modulated that is different from but complimentary to a first motor response produced by the first target tissue; and cause a second signal delivery device to deliver the second modulation signal to the second target tissue to further address the breathing obstruction.

10. The one or more non-transitory, computer-readable media of claim 8 wherein the target tissue is a first target tissue, wherein the modulation signal is a first modulation signal, wherein the signal delivery device is a first signal delivery device, and wherein the instructions further cause the patient treatment system to: determine that a motor response caused by the delivery of the first modulation signal partially addressed the breathing obstruction; select a second target tissue, different from the first target tissue, to receive a second modulation signal, different from the first modulation signal, wherein the second target tissue is selected to aid the first target tissue in causing the motor response when modulated; and cause a second signal delivery device to deliver the second modulation signal to the second target tissue to further address the breathing obstruction.

11. The one or more non-transitory, computer-readable media of claim 8 wherein the target tissue is a first target tissue, wherein the modulation signal is a first modulation signal, wherein the signal delivery device is a first signal delivery device, and wherein the instructions further cause the patient treatment system to: determine that a motor response caused by the delivery of the first modulation signal partially addressed the breathing obstruction; select a second target tissue, different from the first target tissue, to receive a second modulation signal, different from the first modulation signal, wherein the second target tissue is selected to aid the first target tissue in causing the motor response when modulated; and cause a second signal delivery device to deliver the second modulation signal to the second target tissue to further address the breathing obstruction.

12. The one or more non-transitory, computer-readable media of claim 8 wherein the tissue collapse site include a first portion of the patient’s airway associated with the breathing obstruction, wherein the target tissue is a first target tissue selected to at least partially address tissue collapse in the first portion of the airway, wherein the modulation signal is a first modulationsignal, wherein the signal delivery device is a first signal delivery device, and wherein the instructions further cause the patient treatment system to: identifying a second portion of the patient’s airway associated with the breathing obstruction; and selecting a second target tissue, different from the first target tissue, to receive a second modulation signal from a second signal delivery device to at least partially address tissue collapse in the second portion of the airway.

13. The one or more non-transitory, computer-readable media of claim 8 wherein the instructions that cause the patient treatment system to determine the type of tissue collapse include instructions that cause the patient treatment system to: identify a number of candidate tissue collapse types; for each of the number of candidate tissue collapse types — calculate a product of a frequency of the candidate tissue collapse type and a severity of the candidate tissue collapse type, and determine whether the product is equal to or exceeds a predetermined threshold; and when the product for a given one of the candidate tissue collapse types is equal to or exceeds a predetermined threshold, determine the given one of the candidate tissue collapse types is the type of tissue collapse.

14. The one or more non-transitory, computer-readable media of claim 8 wherein the instructions that cause the signal delivery device to deliver the modulation signal include instructions that cause a wearable device of the patient treatment system to wirelessly transmit power to the signal delivery device.

15. A system for addressing a breathing obstruction in an airway of a patient, the system comprising: one or more processors configured to — obtain data characterizing a breathing obstruction in a patient; determine, based on the data, a tissue collapse site in the airway and associated with the breathing obstruction; identify, based on the data, a type of tissue collapse at the tissue collapse site; andselect, based on the tissue collapse site and the type of tissue collapse, a target tissue to receive a modulation signal to at least partially address the breathing obstruction; and a signal delivery device configured to be positioned at least proximate to the target tissue to deliver the modulation signal to the target tissue and thereby at least partially address the breathing obstruction.

16. The system of claim 15 the type of tissue collapse includes a phenotype of the tissue collapse, and wherein the phenotype is based at least in part on a percentage of impacted breaths over a predetermined time period and / or an average percent flow decrease per impacted breath.

17. The system of claim 15 wherein the type of tissue collapse includes an endotype of the tissue collapse, and wherein the endotype is based at least in part on a vector of the tissue collapse.

18. The system of claim 15 wherein the one or more processors are configured to select the target tissue based at least in part on a predetermined ranking of candidate target tissue expected to at least partially address the breathing obstruction.

19. The system of claim 15 wherein the one or more processors are configured to select the target tissue based on an assumption that the patient has received at least two other signal delivery devices positioned to modulate a hypoglossal nerve of the patient and an ansa cervicalis nerve of the patient, respectively.

20. The system of claim 15 wherein the data includes imaging data and / or airway pressure measurements.

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