Method of locating a signal delivery device for treatment of sleep apnea and

Abstract

The present technology generally relates to methods for addressing sleep apnea in a patient. At least some of the methods may include one or more of percutaneously inserting an implantable signal delivery device at an insertion point on a patient's neck, moving the signal delivery device in a medial-to-lateral direction toward a neck loop nerve of the patient, and implanting the signal delivery device at a target location at least proximate the neck loop nerve. The signal delivery device may include at least one electrode positioned to deliver a modulation signal to tissue, such as a portion of a neck loop nerve, at least proximate to a target location. In some embodiments, delivery of the modulation signal may induce a patient's trailing-side traction, thereby addressing sleep apnea in the patient.

Description

[0001] Cross Reference to Related Applications

[0002] This application claims priority to U.S. Provisional Application No. 63 / 452,918, filed March 17, 2023, and U.S. Provisional Application No. 63 / 622,867, filed January 19, 2024. The entire contents of both of the above applications are incorporated herein by reference. TECHNICAL FIELD

[0003] The present technology relates to methods for positioning a signal delivery device to treat sleep apnea, and associated devices and treatments. BACKGROUND

[0004] Obstructive sleep apnea (OSA) is a medical condition in which a patient’s upper airway is obstructed (partially or completely) during sleep, causing sleep arousal. Repeated occlusion of the upper airway can cause sleep fragmentation, which in turn can cause sleep deprivation, daytime fatigue, and / or discomfort. More severe instances of OSA can increase the risk of stroke, arrhythmia, hypertension, and / or other conditions in a patient.

[0005] OSA can be characterized by a tendency of soft tissue of the upper airway to collapse during sleep, thereby obstructing the upper airway. OSA is often caused by the patient’s soft palate, oropharynx, tongue, epiglottis, or a combination thereof collapsing into the upper airway, which in turn can impede normal breathing and / or cause sleep arousal.

[0006] 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 include surgery to remove portions of a patient’s tongue and / or soft palate, as well as other surgeries that attempt to prevent the tongue from collapsing into the back of the pharynx. These surgical techniques are highly invasive. CPAP machines attempt to maintain upper airway patency by applying positive air pressure at the patient’s nose and mouth. However, these machines are uncomfortable, cumbersome, and can have low compliance.

[0007] Some electrical modulation techniques attempt to prevent the tongue from collapsing into the back of the pharynx by causing the tongue to protrude forward (e.g., in an anterior direction) and / or flatten during sleep. However, existing techniques for electrically stimulating nerves of a patient’s oral cavity suffer from being too invasive and / or not effective enough. Thus, there is a need for an improved, minimally invasive treatment for OSA and other sleep disorders. BRIEF DESCRIPTION OF DRAWINGS

[0008] FIG. 1A is a side cross-sectional view depicting a patient’s upper airway.

[0009] FIG. 1Bis a partial schematic view of representative neural structures and muscle tissue of a patient's mandible and neck.

[0010] FIG. 1C is a partial schematic view of the cervical loop nerve.

[0011] FIG. 1D is a front cross-sectional view depicting a portion of a patient's neck and mandible and a signal delivery device positioned in accordance with an embodiment of the present technology.

[0012] FIG. 2A is a front cross-sectional view of a portion of a patient's neck and mandible depicting a signal delivery device insertion path in accordance with an embodiment of the present technology.

[0013] FIG. 2B is a lateral cross-sectional view depicting a series of signal delivery device insertion paths in accordance with an embodiment of the present technology.

[0014] FIG. 2C to FIG. 2E is a lateral cross-sectional view depicting respective signal delivery device insertion paths in accordance with an embodiment of the present technology.

[0015] FIG. 3A and FIG. 3B are a front cross-sectional view and a lateral cross-sectional view, respectively, of a portion of a patient's neck and mandible and depict an angular range of medial-to-lateral signal delivery device insertion paths, each in accordance with an embodiment of the present technology.

[0016] FIG. 3C and FIG. 3D are a front cross-sectional view and a lateral cross-sectional view, respectively, of a portion of a patient's neck and mandible and depict an angular range of lateral-to-medial signal delivery device insertion paths, each in accordance with an embodiment of the present technology.

[0017] FIG. 4A and FIG. 4B is a lateral cross-sectional view of a portion of a patient's neck and mandible and depicts respective signal delivery device implantation locations in accordance with an embodiment of the present technology.

[0018] FIG. 4C is a lateral cross-sectional view depicting a signal delivery device positioned in accordance with an embodiment of the present technology.

[0019] FIG. 5A and FIG. 5B is a lateral cross-sectional view of a portion of a patient's neck and mandible and depicts respective signal delivery device implantation locations in accordance with an embodiment of the present technology.

[0020] FIG. 6A-6D is a lateral cross-sectional view of a portion of a patient's neck and mandible and depicts a signal delivery device positioned in accordance with an embodiment of the present technology at least proximate to a third branch of the patient's cervical loop nerve.

[0021] FIG. 7A is a front cross-sectional view of a portion of a patient’s neck and mandible and a signal delivery device positioned according to embodiments of the present technology.

[0022] FIG. 7B is a side cross-sectional view of a portion of a patient’s neck and mandible and a signal delivery device positioned according to embodiments of the present technology. FIG. 7B

[0023] FIG. 8 is a front cross-sectional view of a portion of a patient’s neck and mandible and a signal delivery device positioned according to embodiments of the present technology.

[0024] FIG. 9A is a side cross-sectional view of a portion of a patient’s neck and mandible anatomy.

[0025] FIG. 9B is a side cross-sectional view of a portion of a patient’s neck and mandible anatomy including a first signal delivery device and a second signal delivery device positioned according to embodiments of the present technology.

[0026] FIG. 10A shows a plot of patient data obtained by directing a modulating signal to a patient’s cervical vagus nerve according to embodiments of the present technology.

[0027] FIG. 10B is a table including data obtained by positioning and activating a signal delivery device according to embodiments of the present technology.

[0028] FIG. 10C is a plot showing airflow recovery for patients listed in the table of FIG. 10B .

[0029] FIG. 11 is a block diagram showing elements of a system for treating sleep disorders according to embodiments of the present technology.

[0030] FIG. 12 is a partial schematic side view showing another signal delivery device configured according to embodiments of the present technology. DETAILED DESCRIPTION

[0031] To facilitate reading, the present technology is discussed under the following headings:

[0032] Title I “Introduction”

[0033] Title II “Overall Patient Physiology” (focusing on FIG. 1A-1D )

[0034] Title III “Representative Insertion Pathways and Target Tissues” (focusing on FIG. 2A-9B )​

[0035] Title IV “Representative Experimental Data” (focusing on FIG. 10A-10C )

[0036] Title V “Additional Apparatus, Systems, and Methods” (focusing on FIG. 11 and FIG. 12 )

[0037] Title VI “Examples”

[0038] While embodiments of the present technology are described under selected headings indicated above, other embodiments of the present technology can include elements discussed under multiple headings. Thus, even if an embodiment can be discussed under a particular heading, the embodiment is not limited only to elements discussed under that heading.

[0039] 1. INTRODUCTION

[0040] Electrical stimulation therapy for obstructive sleep apnea (OSA) generally includes delivering modulation signals that modulate nerves and / or muscles to cause (i) tongue and / or other soft tissue movement and / or (ii) changes in tissue tension (e.g., tightening or stiffening tissue without inducing muscle contraction or extension that includes movement). Thus, electrical stimulation can remove obstructions of the upper airway, and / or prevent the tongue or other soft tissue from collapsing or obstructing the airway. As used herein, the terms “modulation” and “stimulation” are used interchangeably to mean having an effect on nerves, muscles, and / or other tissue that in turn has an effect on one or more motor functions (e.g., breathing-related motor functions).

[0041] Representative methods and devices for reducing the occurrence and / or severity of respiratory disorders, such as OSA, OSA with complete concentric collapse (“CCC”), central sleep apnea, etc., are disclosed herein. In some embodiments, a signal delivery device is implanted at least proximate to or in contact with one or more target tissues of a patient’s upper airway, such as one or more nerves that innervate muscles in the patient’s airway and / or oral cavity. The signal delivery device can be implanted in the patient via a minimally-invasive percutaneous injection. The signal delivery device can receive power wirelessly from an external device and use the power to generate and / or accurately deliver target modulation signals (e.g., electrical signals, stimulation pulses, etc.) to the target tissues, thereby improving the patient’s upper airway patency and / or improving the tension of tissues within the oral cavity to treat sleep apnea. The external device can include one or more mouthpiece portions, neck collar portions, chinstrap portions, pillow portions, mattress cover portions, and / or one or more other suitable wearable structures.

[0042] Representative target tissues include nerves, such as the cervical loop nerve and / or the hypoglossal nerve, which are located near and / or around the mouth or in the neck. Stimulation of the cervical loop nerve can induce tail traction (e.g., tail traction of the trachea), lower or depress the hyoid bone, and / or stabilize or stiffen the soft tissues of the tongue and / or the upper airway. This, in turn, can reduce or prevent tissue collapse and / or other airflow obstruction in the patient's airway, thereby improving airflow through the upper airway and easing or even alleviating respiratory obstruction. For example, because the tongue is attached to the hyoid bone, lowering the hyoid bone can (i) pull 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. Stimulation of the hypoglossal nerve can move the patient's tongue anteriorly / forward and / or improve tissue tension 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. This movement of potentially obstructive tissues in the upper airway / pharynx is expected to improve the patient's sleep by relieving or reducing obstruction. Further target tissues can include one or more muscles innervated by the hypoglossal nerve or the cervical loop nerve (e.g., one or more of the patient's infrahyoid strap muscles, including the sternohyoid muscle and / or the sternothyroid muscle), the glossopharyngeal nerve, the pharyngeal branch of the glossopharyngeal nerve, the pharyngeal plexus, the C2 or C3 spinal nerves, the lateral portions of the epidural space at the C1, C2, and C3 vertebrae, the pharyngeal branch of the glossopharyngeal nerve, and / or other suitable and / or therapeutically effective targets. Thus, the devices and related methods disclosed herein can improve the patient's sleep by moving and / or stabilizing potentially obstructive tissues in the upper airway / pharynx. More specifically, applying modulation signals to one or more portions of the cervical loop nerve and / or directly to one or more of the patient's infrahyoid strap muscles can (i) move the patient's hyoid bone inferiorly (e.g., tail traction), (ii) increase the stiffness of the patient's pharyngeal walls, and / or (iii) otherwise at least partially or completely prevent soft tissue collapse that would otherwise have an obstructive effect on the patient's upper airway.

[0043] Many embodiments of the technology described below can take the form of computer- executable instructions or machine-executable instructions or controller-executable instructions, including program code 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 processing device and can include Internet appliances and handheld devices (including palmtop computers, wearable computers, tablets, cellular or mobile phones, multi-processor systems, processor-based or programmable consumer electronics, network computers, mini-computers, etc.). Information handled by these computer systems can be presented on any suitable display medium, including liquid crystal displays (LCDs). In some embodiments, a manufacturer or other suitable entity can provide instructions to practitioners for performing the methods disclosed herein. The manufacturer can also program the devices of the disclosed system to perform at least some of these methods.

[0044] The technology can also be practiced in distributed computing environments where tasks or modules are performed by remote processing devices, which are linked through a communications network. In a distributed computing environment, program modules or subroutines can be located in both local and remote memory storage devices. Aspects of the technology described below can be stored or distributed on any suitable computer-readable media, including one or more ASICs (e.g., with

[0045] 2. Overall patient physiological condition

[0046] 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, such as specific nerves and / or specific locations along nerves. Such locations include locations along the cervical loop nerve, hypoglossal nerve, and / or vagus nerve of a patient. Additional locations include nerves that innervate airway muscles (e.g., palatine, oropharyngeal, laryngeal, sternohyoid, sternothyroid, sternohyoideus, thyrohyoid, nasalis, hyoid, pharyngeal, infrahyoid, diaphragmatic, and / or intercostal muscles). Target locations can be identified relative to any one or any combination of intrinsic or extrinsic muscles, associated nerve branches, and / or portions thereof, and / or other physiological features.

[0047] FIG. 1AA patient P is shown with respect to a coordinate system, where the x-axis represents the anterior-posterior direction, the y-axis represents the superior-inferior direction and / or the cranial-caudal direction, and the z-axis represents the medial-lateral direction. The patient P has a hard palate HP that covers a tongue T and forms a roof of an oral cavity OC (e.g., a mouth). The hard palate HP includes a bone support BS and thus is generally not deformed during breathing. A soft palate SP made of soft tissue such as membrane, fibrous material, adipose tissue, and muscle tissue extends posteriorly (e.g., in a posterior direction) from the hard palate HP toward a posterior of a pharynx PHR. More specifically, an anterior end AE of the soft palate SP is anchored to a posterior end of the hard palate HP, and a posterior end PE of the soft palate SP is unattached. Because the soft palate SP does not contain bone or cartilage, the soft palate SP is flexible and can collapse onto the posterior of the pharynx PHR and / or swing back and forth (e.g., particularly during sleep).

[0048] The pharynx PHR is a laryngeal portion that is located inferior to the nasal cavity NC, posterior to the oral cavity OC, and superior to the esophagus ES, which conveys air from the oral cavity OC and the nasal cavity NC into the trachea TR. The pharynx PHR is separated from the oral cavity OC by the palatoglossal arches PGA, which extend downward on either side to the root of the tongue T. Although not shown for simplicity, the pharynx PHR includes a nasopharynx, a palatopharynx, an oropharynx, and a laryngopharynx. The nasopharynx is located between the base of the skull and the soft palate SP. The palatopharynx is the portion of the nasopharynx bounded by the ventral side of the soft palate SP. The oropharynx is located behind the oral cavity OC and extends from the soft palate SP to the pharyngeal FIG. 1B The stimulation of one or more of the patient's hyolaryngeal band muscles (and / or the nerve that innervates one or more of the patient's hyolaryngeal band muscles) can lower the hyoid bone HB, including at least the root of the patient's tongue T, in an anterior or posterior direction shown using dashed arrows, and produce a corresponding movement of at least the root of the patient's tongue T. As described in more detail below, lowering the root of the patient's tongue T can open the patient's airway, and / or reduce or prevent collapse of tissue that at least partially obstructs the patient's airway, to increase airflow through the oral cavity OC and address OSA and / or other respiratory obstructions.

[0049] FIG. 1Bis a partial illustration of representative neural structures and muscle tissue of a patient's mandible and neck. 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 associated branches emanating therefrom innervate the omohyoid muscle OHM, the sternohyoid muscle SHM, and the sternothyroid muscle STM. The ansa cervicalis AC can also extend at least partially parallel to and / or around the patient's internal jugular vein IJV. FIG. 1B Also shown are the patient's mandible M, the mylohyoid muscle MLH, and the digastric muscle DG (more specifically, the anterior belly of the digastric muscle DG), as well as the sternothyroid muscle STM, the sternocleidomastoid muscle SCM, and the sternohyoid muscle SHM. The sternohyoid muscle SHM and the sternothyroid muscle STM extend on (e.g., anterior to) the patient's larynx L. The above-mentioned muscles are included within the patient's oral cavity OC, neck N, and / or shoulder SH. As described in greater detail below, embodiments of the present technology can control, reduce, and / or eliminate the effects of OSA by positioning and activating a minimally invasive electrode at least proximate to one or more of the aforementioned neural structures and / or associated muscle tissue.

[0050] FIG. 1C is a partial illustration of several arrangements of the ansa cervicalis nerve AC. Specifically, FIG. 1CMedial arrangement 101a of the accessory nerve AC, lateral arrangement 101b of the accessory nerve AC, and mixed arrangement 101c of the accessory nerve AC are shown. In each of these arrangements, the accessory nerve AC includes a superior root SR, an inferior root IR, a first branch Bl that innervates the superior belly of the omohyoid muscle OHMs and the superior belly of the sternohyoid muscle SHMs, a second branch B2 that innervates the inferior belly of the omohyoid muscle OHMi, and a third branch B3 to both the sternohyoid muscle SHM and the sternothyroid muscle STM. More specifically, the third branch B3 can bifurcate / split into a first sub-branch B3a that innervates the sternothyroid muscle STM and a second sub-branch B3b that innervates the inferior belly of the sternohyoid muscle SHMi. The hypoglossal nerve HGN, the cranial nerves C1-C3, the internal jugular vein IJV, and the common carotid artery CCA are shown for context. In the medial arrangement 101a (left), the inferior root IR extends posterior to (e.g., behind) the internal jugular vein IJV. In the lateral arrangement 101b (middle), the inferior root IR is positioned anterior to (e.g., in front of) the internal jugular vein IJV. In the mixed arrangement 101c (right), the inferior root IR is positioned at least partially around the internal jugular vein IJV, with an upper / superior portion of the inferior root IR extending posterior to the internal jugular vein IJV and a lower / inferior portion of the inferior root IR extending anterior to the internal jugular vein IJV. In each of these arrangements 101a-c, the positioning and / or location of the third branch B3 and the respective sub-branches B3a and B3b are expected to be at least approximately similar or identical. As such, the third branch B3 and / or its sub-branches B3a, B3b are particular target locations of the present technology, at least because these branches are expected to be more easily identifiable and / or because the third branch B3 innervates multiple infrahyoid strap muscles (e.g., the sternothyroid muscle STM and the inferior belly of the sternohyoid muscle SHMi). However, one of ordinary skill in the art will appreciate that in practice, the systems and methods of the present technology can still be used to address OSA in such patients by targeting other portions of the accessory nerve AC.

[0051] FIG. 1Dis a partial schematic view of representative neural structures and muscle tissue of a patient's mandible and neck and a signal delivery device 100 positioned in accordance with embodiments of the technology. The signal delivery device 100 (schematically shown) can include a housing 102, one or more electrodes 104, a signal generator 106, and an antenna 108. The housing 102 can include a first end 102a and a second end 102b opposite the first end 102a. Individual ones of the electrodes 104 can be positioned on and / or at least partially around the housing 102 (e.g., the first end 102a of the housing 102). In some embodiments, the electrodes 104 can be masked (e.g., circumferentially masked), segmented (e.g., circumferentially segmented and individually addressable), oriented, at least partially covered, and / or otherwise configured to direct an electric field in a particular direction(s). The signal generator 106 and the antenna 108 can be positioned at least partially or completely within the housing 102, e.g., at or near the second end 102b of the housing 102. The signal delivery device 100 can be secured in place at least proximate to or within one or more target neural and / or muscle structures using one or more anchors, sutures, and / or other suitable devices.

[0052] In operation, the antenna 108 can be configured to wirelessly receive a power signal (e.g., radio frequency "RF", inductive, etc.) from one or more devices (such as one or more wearable devices) external to the patient P. The RF power signal or at least a portion of the RF power signal can have a frequency in a range from about 300 MHz to about 6 GHz, e.g., from about 400 MHz to about 2.5 GHz, from about 600 MHz to about 2.45 GHz, from about 900 MHz to about 1.2 GHz, or any other intermediate frequency or frequency range. The inductive power signal or at least a portion of the inductive power signal can have a frequency in a range from about 100 kHz to about 14 MHz, including, e.g., about 135.7 kHz, about 6.5 MHz, about 13.5 MHz, and / or another suitable frequency and / or frequency range. In these and / or other embodiments, the wireless power signal or at least a portion of the wireless power signal can have a frequency or frequency range in the industrial, scientific, and medical band ("ISM band").

[0053] Power received at the antenna 108 can be sent to the signal generator 106, which can use the power to generate one or more electrical pulses or signals. In at least some embodiments, the power received at the antenna 108 (e.g., AC power) is rectified to DC (via, e.g., an AC-DC converter), and then the DC is sent to a DC-DC converter, charge pump, and / or transformer. In some embodiments, the power is converted to pulses at a frequency in the range of about 10 Hz to about 500 Hz, e.g., about 30 Hz to about 300 Hz. In other embodiments, the pulses can be delivered at a higher frequency (e.g., 10 kHz or higher) and / or in bursts. In a voltage-controlled system, the amplitude of the signal can be about 1 mV to about 5 V (and in particular embodiments, 1 V to 2 V), or in a current-controlled system, the amplitude of the signal can be about 0.5 mA to about 12 mA. The pulse width can be between about 10 ps and about 1000 ps, such as at least 10 ps, 50 ps, 100 ps, 150 ps, 250 ps, 500 ps, or another suitable pulse width. In the illustrated embodiment, all signal generation functions are performed by the signal generator 106, and in other embodiments, some signal generation functions can be performed by external elements. The signal generation and signal delivery functions can be performed by a single signal delivery device or multiple devices.

[0054] The signals generated by the signal generator 106 can be transmitted to one or more electrodes 104, which in turn can deliver the signals to the target neural and / or muscular structures. The electric field(s) produced by the current transmitted by the electrodes 104 produce a desired effect (e.g., excitation and / or inhibition) at the target nerve. In at least some embodiments, the signal delivery device 100 need not include any on-board power storage elements (e.g., power capacitors and / or batteries) or any power storage elements having a storage capacity greater than 0.5 seconds in order to reduce system volume. In other embodiments, the signal delivery device 100 can include one or more small charge storage devices (e.g., low voltage, high capacitance capacitors, solid state batteries, etc.) that are compatible with the overall compact shape of the signal delivery device 100 and have a total charge storage capacity of no more than 1 second, 5 seconds, 10 seconds, 15 seconds, 20 seconds, 25 seconds, 30 seconds, 1 minute, 2 minutes, 5 minutes, any time period in between, or another suitable time period, depending on the embodiment. In further embodiments, the signal delivery device 100 includes one or more power storage elements configured to store charge for an extended period of time. Such signal delivery devices 100 can be configured for use with wearable devices that omit a power transmission device. In at least some embodiments, the modulation signals delivered to the patient can be delivered via a dipole formed by two of the electrodes 104. In other embodiments, the signal delivery device 100 can be monopolar, with at least a portion of the housing 102 (e.g., the first end 102a of the housing 102) forming a ground or return electrode and / or with a ground electrode positioned elsewhere (e.g., subcutaneously at another location, external to the patient's body, etc.). In these and other embodiments, the modulation signals can include monophasic waveforms, biphasic and / or charge balanced waveforms, and / or another suitable waveform.

[0055] The signal delivery device 100 can include additional on-board components and / or functionality. In some embodiments, the signal delivery device 100 includes one or more sensors. The sensors can include a motion sensor configured to detect vibrations induced by apnea / snoring / hypopnea, motion, and / or patient body orientation. The sensors can also include a respiration rate sensor, a respiration amplitude sensor, a heart rate sensor, an Sp02 sensor, and / or one or more other sensors configured to detect information associated with the patient's respiration and / or sleep state. The data generated by the sensors can be processed on the signal delivery device 100 and / or transmitted to an external control unit, e.g., to provide closed loop control of the signal delivery device 100 and / or the generation of modulation signals based at least in part on the sensed data.

[0056] Although in the foregoing description, the signal delivery device 100 is described as being implanted in the patient's body, in other embodiments, the signal delivery device 100 can be positioned external to the patient's body (e.g., on the patient's body, on a bed, on a table, etc.). In these and other embodiments, the signal delivery device 100 can be configured to deliver modulation signals to the patient's body via one or more electrodes positioned external to the patient's body. FIG. 1DA single signal delivery device 100 is shown, but in some embodiments, one or more additional signal delivery devices may be positioned to deliver modulating signals to (i) other parts of the cervical loop AC, (ii) one or more branches of the cervical loop, and / or (iii) one or more of the patient's subhyoid band muscles. Reference is made below. FIG. 2A to FIG. 9B Describe additional details regarding the location of the signal delivery equipment.

[0057] 3. Representative insertion paths and target tissues

[0058] refer to FIG. 2A-9B Several modulatory targets and implantation techniques are described and / or illustrated. For clarity, these modulatory targets and implantation techniques are shown on the left or right side of the patient P's anatomy, for example, the first or left loop nerve of the neck and / or the first or left infrahyoid band muscle of the patient P. However, it should be understood that reference to... FIG. 2A-9B At least some or all of the modulation targets and / or implantation techniques described and / or illustrated are equally applicable to applications on the other side of a patient's anatomy, such as the second or right loop cervical nerve and / or the second or right infrahyoid band muscle of patient P. Additionally, at least some of the modulation targets and / or implantation techniques can be used for bilateral signal delivery, for example, to apply a first modulation signal to a first modulation target on a first side of patient P at a first time, and to apply a second modulation signal to a second modulation target on one side of patient P at the same or different times. The second modulation signal may be the same as or different from the first modulation signal. In some embodiments, the first and second modulation targets may be corresponding left and right portions of a patient's anatomy, such as the first and second portions of the left and right loop cervical nerves. In other embodiments, the first and second modulation targets may be different, such as the left loop cervical nerve and the infrahyoid band muscle on the right side of the patient.

[0059] Current surgical device placement methods for treating OSA target the hypoglossal nerve, but approximately 35–45% of patients experience little or no positive impact from treatment / signal reception delivered to this target. Furthermore, many patients considered responders to hypoglossal nerve modulation still have a residual apnea-hypopnea index (“AHI”). Even after optimizing the modulation settings, such patients experience only a 50–70% reduction in their AHI, indicating that these patients still experience apnea and / or hypopnea during and / or after hypoglossal nerve modulation therapy. These patients may also experience undesirable awakenings, tongue chafing, snoring, and / or other side effects of hypoglossal nerve modulation therapy that are expected to reduce patient compliance—for example, current methods have a user compliance rate of less than 80%.

[0060] Further, current OSA treatment methods stimulate the base of the back of the tongue, but do not stiffen the rest of the airway. While the airway of a large number of OSA patients exhibits posterior tongue collapse (e.g., collapse of the base of the tongue), almost all OSA patients have posterior palate (e.g., palatopharyngeal and / or oropharyngeal) tissue collapse. Hypoglossal nerve modulation can not effectively increase airway patency at the level of the posterior palate in all patients. It is expected that hypoglossal AC modulation improves (e.g., reduces) airway collapse in the posterior palate region without affecting the ability of hypoglossal nerve modulation to reduce or prevent posterior tongue collapse. Thus, hypoglossal AC modulation alone or in combination with hypoglossal nerve modulation is expected to provide a therapeutic solution for a wider range of collapse sites in the upper airway, resulting in (1) more effective treatment for patients whose collapse pattern (e.g., posterior palate) is not fully targeted by hypoglossal nerve modulation alone, and (2) an expanded potential population in which nerve modulation can be an effective treatment by targeting additional collapse sites. While hypoglossal modulation itself is expected to improve or even correct respiratory obstruction, the combination of hypoglossal AC and hypoglossal nerve modulation is expected to provide a multiplicative effect and / or otherwise enhance the magnitude of treatment (e.g., a higher level of collapsibility can be treated) compared to hypoglossal AC modulation treatment alone or hypoglossal nerve modulation treatment alone. This can allow for treatment of patients with higher body mass index (BMI), and / or treatment of patients with more collapsible airways, such as patients with higher therapeutic CPAP values.

[0061] Stimulating one or more of the hypoglossal AC and / or the strap muscles of the patient is expected to move the hyoid bone downward by contracting the strap muscles, resulting in caudal traction. Caudal traction has been documented as a mechanism that stiffens one or more tissues defining the patient's upper airway (e.g., the glottis, vocal cords, etc.) and / or otherwise increases upper airway stability to at least partially resolve symptoms of OSA. For example, lowering the hyoid bone can cause the tongue or at least the back of the tongue to change its position relative to the patient's airway without inducing or generally inducing contraction of the tongue muscles. For example, lowering the hyoid bone can stretch the tongue downward, thereby opening (or further opening) the patient's airway (or at least the posterior tongue portion of the patient's airway) to increase airflow therethrough. Further, stimulating the hypoglossal nerve and / or genioglossus muscle is expected to contract the back of the tongue. Pharyngeal wall stiffening is another effect of the contraction of the strap muscles on the upper airway, which can complement caudal traction. Thus, hypoglossal modulation can improve or even completely restore the patient's airflow obstruction on its own.

[0062] Combination therapy (e.g., targeting the hypopharyngeal AC and the hypoglossal nerve, and / or one or more of the muscles innervated by these nerves) is expected to provide multiple physiological responses that reduce or prevent airway obstruction in a patient. For example, the use of combined genioglossus and hyolaryngeal muscle contractions is expected to prevent or at least partially prevent multi-site collapse, e.g., by addressing both palatal and tongue collapse, with simultaneous and / or complementary physiological responses. Such genioglossus contractions can be achieved via, e.g., hypopharyngeal AC modulation, genioglossus modulation, and / or hyoid modulation, and such hyolaryngeal muscle contractions can be achieved via hypoglossal nerve modulation, direct hyolaryngeal muscle modulation, and / or hyoid modulation. Thus, combination therapy is expected to improve outcomes for patients who have responded to individual target modulation (e.g., hypopharyngeal AC or hypoglossal nerve) but still have residual respiratory obstruction (e.g., residual tongue collapse after hypopharyngeal AC modulation; palatal narrowing / collapse and / or residual snoring / AHI, etc. after hypoglossal nerve stimulation). For example, embodiments of the present technology are expected to reduce the number and / or frequency of apnea and / or hypopnea events experienced by a patient during a period of time (e.g., during and / or after modulation signal delivery). Additionally or alternatively, multi-site signal delivery is expected to increase the potential patient responder population to include patients who would not otherwise respond to individual target modulation alone. This includes patients who have received hypoglossal nerve stimulation but have primary palatal (e.g., palatopharyngeal) collapse, lack a soft palate connection, have a BMI > 32, and / or have a fully concentric airway collapse.

[0063] In some embodiments, the combination of hypopharyngeal AC and hypoglossal nerve modulation is expected to reduce patient arousal, e.g., by reducing or preventing overmodulation of the tongue base, which can be done to entrain the soft palate. For example, positioning signal delivery devices to target multiple nerve / muscle groups can provide effective therapy while operating one or more of the devices at lower amplitudes than would be required if targeting only one nerve / muscle group. Additionally or alternatively, positioning multiple signal delivery devices to target selected nerves / muscles can provide effective therapy while inducing only partial contraction / motor response in one or more of the associated muscles (e.g., stiffening or otherwise improving the tone of the associated muscle without or substantially without inducing a twitch or full contraction). By reducing the effective treatment amplitude and / or motor response at one or more target modulation sites, embodiments of the present technology are expected to generate lower patient arousal rates without or substantially without compromising effective physiological response. Thus, this approach can increase patient compliance, overall treatment efficacy, and / or sleep quality for the patient.

[0064] Reference FIG. 2A-9BAdditional details are described regarding techniques for positioning a signal delivery device to deliver a modulating signal to the hypoglossal nerve. Additional details regarding positioning a signal delivery device to deliver a modulating signal to the hypoglossal nerve are described in U.S. Application No. 18 / 393,537, filed December 21, 2023, the entirety of which is incorporated by reference herein.

[0065] FIG. 2A is a side cross-sectional view of a portion of a patient’s upper airway according to an embodiment of the technology, depicting a signal delivery device 100 at a target location at least proximate to one or more target tissues. In the illustrated embodiment, the target location is superior to a third branch B3 of the ansa cervicalis AC. In these and / or other embodiments, the target location can be at least proximate to one or more other portions of the ansa cervicalis AC. When positioned at least proximate to the target tissue, the signal delivery device 100 can be between about 10 mm and about 0.01 mm from the target tissue, such as (i) within 9 mm, 8 mm, 7 mm, 6 mm, 5 mm, 4 mm, 3 mm, 2 mm, 1 mm, or 0.1 mm of the target tissue, (ii) in contact with at least a portion of the target tissue, (iii) within any distance therebetween, or (iv) within another suitable distance from the target tissue.

[0066] The signal delivery device 100 can be positioned at the target location via an insertion path 210 that extends in a direction from medial to lateral and, for example, posteriorly from at least proximate to a midline or mid-sagittal plane of the patient P toward the target location. One or more of the electrodes 104 can be positioned to deliver a signal to the target tissue at or at least proximate to the ansa cervicalis nerve, and delivering the signal to the target tissue can cause caudal traction and / or otherwise address OSA of the patient.

[0067] In the illustrated embodiment, the insertion path 210 is used to position the signal delivery device 100 perpendicular or at least generally perpendicular to the mid-sagittal plane, such as parallel or at least generally parallel to the transverse or x-z plane. In other embodiments, the insertion path 210 can be used to position the signal delivery device 100 in an orientation such that at least one component (e.g., a vector component) of the orientation is aligned along the inferior-superior / cranial-caudal axis. In such embodiments, the signal delivery device 100 is not positioned merely parallel to the x-z plane. Rather, a vector component (e.g., an effective vector component) of the orientation of the signal delivery device 100 can be aligned along the y-axis. For example, as described below with reference to FIGS. 6A-6C, the signal delivery device 100 can be positioned in an orientation such that a vector component of the orientation is aligned along the y-axis. FIG. 5A and FIG. 5B As described in greater detail, the first end 102a of the signal delivery device 100 can be positioned superior to the second end 102b of the signal delivery device 100, or the second end 102b can be positioned superior to the first end 102a.

[0068] In some embodiments, the insertion point or opening 212 can be formed in the patient's neck N, such as at least near the mid-sagittal plane, and the signal delivery device 100 can be moved through the opening 212 and along the insertion path 210. In the illustrated embodiment, the opening 212 is a percutaneous opening formed using a percutaneous or other minimally-invasive insertion tool 214, such as a needle (e.g., a percutaneous injection needle), a stylet, an introducer, a dilator, and / or a trocar, without performing dissection of the submental SM region. Additionally or alternatively, the percutaneous insertion tool 214 can be used to position the signal delivery device 100 within the patient, such as when the signal delivery device 100 is positioned at least near the target location, by having the signal delivery device 100 protrude outwardly from within the percutaneous insertion tool 214 or otherwise release the signal delivery device 100 from the percutaneous insertion tool 214.

[0069] At least a portion of the signal delivery device 100 (e.g., the second end 102b) can be positioned posterior to one or more of the patient's infrahyoid strap muscles (e.g., the sternohyoid muscle SHM, the sternothyroid muscle STM, and / or the omohyoid muscle OHM). For example, the opening 212 can be formed at or near the mid-sagittal plane, and the insertion path 210 can extend posterior to one or more of the sternohyoid muscle SGM, the sternothyroid muscle STM, and / or the omohyoid muscle OHM without penetrating or substantially penetrating one or more of the infrahyoid strap muscles. Additionally or alternatively, the insertion path 210 can extend anterior to one or more of the sternohyoid muscle SHM, the sternothyroid muscle STM, and / or the omohyoid muscle OHM. In these and / or other embodiments, the insertion path 210 can extend between the sternohyoid muscle SHM and the sternothyroid muscle STM, and / or between the sternohyoid muscle and the omohyoid muscle OHM. In some embodiments, all or a portion of the signal delivery device 100 can be positioned between and / or within each of the infrahyoid strap muscles.

[0070] FIG. 2AA portion of a representative ultrasound probe 201 is also schematically shown, which can be used to assist in identifying where the opening 212 is formed, identifying the target location, moving the signal delivery device 100 along the insertion path 210, and / or otherwise positioning the signal delivery device 100 at least near the target location. The ultrasound probe 201 can be used to visualize the target location, the signal delivery device 100, and / or the percutaneous insertion tool 214 before, during, and / or after the procedure to position the signal delivery device 100 at least near the target location. In such embodiments, alignment of the signal delivery device 100 and the orientation of the ultrasound probe 201 is contemplated to increase the speed and / or accuracy of positioning the signal delivery device 100. In these and other embodiments, the ultrasound probe 201 can be used to guide the signal delivery device 100 to the target location. The signal delivery device 100 (or, in some embodiments, the insertion tool 214) can deliver modulation signals during all or part of the implantation procedure, allowing the practitioner to observe the patient's response to the modulation signals, for example, to confirm that the signal delivery device 100 is at or near the target location and / or to notify of further adjustments to the positioning of the signal delivery device 100. This is described in more detail in U.S. Application No. 17 / 666,464 and U.S. Provisional Application No. 18 / 104,739, the entire contents of which are incorporated herein by reference.

[0071] although FIG. 2A The insertion path 210 shown extends in a medial-to-lateral direction, but in other embodiments, the insertion path 210 may extend in a lateral-to-medial direction, for example, in the opposite direction to the shown insertion path 210 and / or toward the patient's midsagittal plane. In such embodiments, the opening 212 may be formed at a location laterally spaced from the target location.

[0072] FIG. 2Bis a cross-sectional view through a patient's neck N at the third cervical vertebra C3, and illustrates one example of an angular insertion range 215 in accordance with embodiments of the technology. The insertion range 215 can be determined relative to a sagittal plane or x-y plane of the patient P, a coronal plane or y-z plane of the patient P, and / or one or more other suitable anatomical structures and / or reference features of the patient P. For a given target location, such as the cervical loop AC, the patient's trachea TR can at least partially define an innermost limit of the range of the insertion path 215. In the illustrated embodiment, the internal jugular vein IJV defines an outermost limit of the range of the insertion path 215, although in other embodiments the external jugular vein EJV, the common carotid artery CCA, and / or the vagus nerve VG can at least partially define the outermost limit of the range of the insertion path 215. The insertion range 215 can be greater than or less than the illustrated insertion range at different vertebral levels (e.g., C2, C4, C5, C6, C7, T1, etc.). The insertion range 215 can be an angle of up to 180 degrees, 170 degrees, 135 degrees, 90 degrees, 45 degrees, 15 degrees, 5 degrees, or any range of angles therebetween. In some embodiments, a preferred insertion path is within 5 degrees, 10 degrees, 20 degrees, 30 degrees, 45 degrees, or 90 degrees of the innermost or outermost limit of the range of the insertion path 215. Although the insertion range 215 is illustrated on the left side of the patient P, those of ordinary skill in the art will appreciate that at least a generally similar or identical insertion range can be used to position a signal delivery device on the right side of the patient P.

[0073] FIG. 2C is a cross-sectional view depicting an insertion path 210' in accordance with embodiments of the technology. The insertion path 210 can be an insertion path through a patient's neck N at the third cervical vertebra C3, and illustrates one example of an angular insertion range 215 in accordance with embodiments of the technology. The insertion range 215 can be determined relative to a sagittal plane or x-y plane of the patient P, a coronal plane or y-z plane of the patient P, and / or one or more other suitable anatomical structures and / or reference features of the patient P. For a given target location, such as the cervical loop AC, the patient's trachea TR can at least partially define an innermost limit of the range of the insertion path 215. In the illustrated embodiment, the internal jugular vein IJV defines an outermost limit of the range of the insertion path 215, although in other embodiments the external jugular vein EJV, the common carotid artery CCA, and / or the vagus nerve VG can at least partially define the outermost limit of the range of the insertion path 215. The insertion range 215 can be greater than or less than the illustrated insertion range at different vertebral levels (e.g., C2, C4, C5, C6, C7, T1, etc.). The insertion range 215 can be an angle of up to 180 degrees, 170 degrees, 135 degrees, 90 degrees, 45 degrees, 15 degrees, 5 degrees, or any range of angles therebetween. In some embodiments, a preferred insertion path is within 5 degrees, 10 degrees, 20 degrees, 30 degrees, 45 degrees, or 90 degrees of the innermost or outermost limit of the range of the insertion path 215. Although the insertion range 215 is illustrated on the left side of the patient P, those of ordinary skill in the art will appreciate that at least a generally similar or identical insertion range can be used to position a signal delivery device on the right side of the patient P. FIG. 2Blinear or at least approximately linear insertion path that is within an angular insertion range 215. For example, the insertion path 210 can be at an angle A (in the transverse or x-z plane and / or relative to the mid-sagittal plane) between about 0 degrees and about 135 degrees, such as between about 45 degrees and about 80 degrees, between about 60 degrees and about 80 degrees, or other angles that avoid the trachea, internal jugular vein IJV, external jugular vein EJV, common carotid artery CCA, and / or vagus nerve VG in a particular patient. The insertion path 210 can extend at least partially or entirely through one or more of the infrahyoid strap muscles (e.g., the sternohyoid SHM, sternothyroid STM, and / or omohyoid OHM) and / or the sternocleidomastoid muscle, and / or can be used to position the signal delivery device 100 at least partially behind and / or within the sternocleidomastoid muscle SCM of a patient. The at least approximately linear insertion path 210 is expected to increase the speed and / or accuracy with which the signal delivery device 100 can be positioned (e.g., by a practitioner) at least proximate to a target location by, for example, minimizing or eliminating the need to re-orient the signal delivery device 100 during insertion. The medial-to-lateral insertion path 210 is expected to increase patient safety by, for example, reducing or preventing injury to the vasculature of a patient, such as the internal jugular vein IJV. For example, as shown in FIG. 2A, the internal jugular vein IJV is located posterior to the cervical loop AC, and the insertion path 210 can position the signal delivery device 100 at least proximate to the cervical loop AC before the signal delivery device 100 reaches the depth at which the internal jugular vein IJV is located. Additionally or alternatively, the angle of the insertion path 210 can be selected to bypass or otherwise avoid positioning the internal jugular vein IJV along the insertion path 210. In some embodiments, inserting and / or implanting the signal delivery device to avoid the internal jugular vein IJV and / or other blood vessels of a patient can prevent or at least partially prevent the delivery of a modulatory signal to a blood vessel of a patient that can cause undesirable vasodilation and / or vasoconstriction. In some embodiments, inserting and / or implanting the signal delivery device to avoid the internal jugular vein IJV and / or other blood vessels of a patient can prevent or at least partially prevent the signal delivery device from resting against a blood vessel of a patient, which in turn can reduce or prevent erosion or weakening of the blood vessel tissue (e.g., due to contact / friction between the signal delivery and the blood vessel). FIG. 2C

[0074] FIG. 2D ​is a lateral cross-sectional view depicting another insertion path 210’’ of an embodiment according to the present technology. The insertion path 210a can include a plurality of insertion path segments or portions 216a-b that are angled relative to one another. In the illustrated embodiment, for example, the insertion path 210a includes a first or proximal path portion 216a and a second or distal path portion 216b. The first path portion 216a is at a first angle Al relative to the mid-sagittal plane in the lateral or x-z plane. The second path portion 216b can be at a second angle A2 relative to the mid-sagittal plane in the lateral or x-z plane and / or at a third angle A3 relative to the first path portion 216a in the lateral or x-z plane. The first angle Al, the second angle A2, and / or the third angle A3 can be between about 0 degrees and about 135 degrees, such as between about 45 degrees and about 80 degrees, between about 60 degrees and about 80 degrees, any suitable angle therebetween, or another suitable angle. Additionally or alternatively, the first angle Al can be less than or greater than the second angle A2 and / or the third angle A3, the second angle A2 can be less than or greater than the first angle Al and / or the third angle A3, and / or the third angle A3 can be less than or greater than the first angle Al and / or the second angle A2. Each of the insertion path portions 216a-b can be associated with a change in orientation of the signal delivery device 100 (e.g., made by a practitioner during insertion). In at least some embodiments, each of the insertion path portions 216a-b has one or more vector components aligned along the medial-lateral (e.g., z) axis and / or the anterior-posterior (e.g., y) axis that are expected to (i) reduce or minimize changes in orientation of the signal delivery device 100 during insertion and (ii) increase the speed and / or accuracy with which the signal delivery device 100 can be positioned at least proximate to the target location. In other embodiments, one or more of the insertion path portions can have another suitable alignment.

[0075] FIG. 2E is a cross-sectional view depicting yet another insertion path 210’’’ of an embodiment according to the present technology. The insertion path 210’’’ can be an insertion path that is FIG. 2Blinear path or at least generally linear insertion path that is within the angular insertion range 215. For example, the insertion path 210’’’ can begin at an opening 212’ formed lateral and / or anterior to the external jugular vein EJV and extend inward in a lateral-to-medial direction anterior to the external jugular vein EJV and toward the carotid loop AC. The insertion path 210’’’ can extend at least partially or entirely through the patient’s sternocleidomastoid muscle SCM. Such a lateral-to-medial insertion path 210’’’ is expected to reduce or prevent injury to the patient’s vasculature and / or increase patient safety. For example, using the insertion path 210’’’, the clinician or other user can advance the signal delivery device 100 toward the carotid loop AC without the insertion path 210’’’ intersecting or even being directed toward one or more of the patient’s blood vessels proximate the carotid loop AC (e.g., the external jugular vein EJV, the internal jugular vein IJV, etc.). This can simplify navigation to the carotid loop AC because over-insertion of the signal delivery device 100 along the insertion path 210’’’ is less likely to puncture the patient’s vasculature as compared to an insertion path that is directed toward the patient’s vasculature.

[0076] As shown in FIGS. 1 1 A and 1 1 B, the signal delivery device 100 is positioned subcutaneously, e.g., at least partially positioned posterior to one or more muscles (e.g., the sternocleidomastoid muscle SCM) in the patient’s neck N. It is believed that with a subcutaneous-only placement, the signal delivery device 100 can be visible beneath the patient’s skin, which can be undesirable to the patient and / or the patient can be able to physically manipulate the signal delivery device 100, which can alter the position of the signal delivery device 100 relative to the target tissue. However, with at least partial placement submuscularly, such as shown in FIGS. 12A and 12B, the signal delivery device 100 is not expected to be visible to and / or manipulatable by the patient. FIG. 2C to FIG. 2E FIG. 2C and FIG. 2D

[0077] FIG. 3A and FIG. 3B ​​These are front and side sectional views, respectively, of a portion of the patient's neck and mandible, illustrating the lower-upper portion of the angular range 318 of the medial-lateral approach for the insertion signal delivery device 100 according to an embodiment of the present technology. The angular range 318 can be determined relative to, for example, the transverse plane or xz plane of the patient P and / or one or more other suitable anatomical structures and / or reference features of the patient P. For a given target location, the patient's jaw J and / or hyoid bone HB can at least partially define the uppermost limit of the range of the insertion path 318. The clavicle CL and / or shoulder SH can at least partially define the lowermost limit of the range of the insertion path 318. In some embodiments, the insertion path preferably bisects the range of the insertion path 318, or is within ±20 degrees, 15 degrees, 10 degrees, 5 degrees, or 1 degree, or avoids the trachea TR in a particular patient. FIG. 2B ), Internal jugular vein IJV ( FIG. 2B External jugular vein EJV ( FIG. 2B ), common carotid artery CCA ( FIG. 2B ) and / or vagus nerve VG ( FIG. 2B At other angles. The patient's cervical neck and / or jaw can be manipulated to increase the angle range 318. For example, the practitioner can rotate or roll the patient's jaw backward to increase access to the cervical neck and / or jaw. Additionally or alternatively, by using a short-length insertion tool or needle, the practitioner can utilize... FIG. 3A and FIG. 3B The angle range 318 shown represents a wider range of insertion paths, including, for example, vertically aligned insertion paths and / or implantation orientations, as referenced below. FIG. 5A and FIG. 5B Detailed description.

[0078] FIG. 3C and FIG. 3D These are front and side sectional views, respectively, of a portion of the patient's neck and mandible, illustrating the angular range 318' of the lower-upper portion of the lateral-medial approach for inserting the signal delivery device 100 according to an embodiment of the present technology. The lowermost and / or uppermost limits of the angular range of the lateral-medial approach can be determined by referring to the above reference. FIG. 3A and 3B The described medial-lateral approach is defined by at least substantially similar or identical anatomical structures. For example, for a given target location, the patient's jaw J and / or hyoid HB may at least partially define the uppermost limit of the range of the insertion path 318', and the clavicle CL and / or shoulder SH may at least partially define the lowermost limit of the range of the insertion path 318'. In some embodiments, the insertion path preferably bisects the range of the insertion path 318', or is within ±20 degrees, 15 degrees, 10 degrees, 5 degrees, or 1 degree, or avoids the tracheal TR in a particular patient. FIG. 2B), Internal jugular vein IJV ( FIG. 2B External jugular vein EJV ( FIG. 2B ), common carotid artery CCA ( FIG. 2B ) and / or vagus nerve VG ( FIG. 2B At other angles. The patient's cervical neck and / or jaw can be manipulated to increase the angle range of 318'. For example, the practitioner can rotate or roll the patient's jaw backward to increase access to the cervical neck and / or jaw. Additionally or alternatively, by using a short-length insertion tool or needle, the practitioner can utilize... FIG. 3C and 3D The 318' angle range shown represents a wider range of insertion paths, including, for example, vertically aligned insertion paths and / or implantation orientations, as referenced below. FIG. 5A and 5B Detailed description.

[0079] FIG. 4A to FIG. 8 Additional locations where the signal delivery device 100 can be implanted are shown. Although FIG. 4A to FIG. 8 A signal delivery device 100 is shown positioned in a particular orientation and at least close to one or more specific target tissues, but those skilled in the art will understand that the signal delivery device 100 may be positioned in other orientations and / or at other target tissues.

[0080] Reference FIG. 4A The signal delivery device 100 is positioned at least generally anterior-posteriorly and is located at least near the superior root SR of the cervical loop and / or the branch B1 of the cervical loop AC innervating the omohyoid OHM. In this position, the signal delivery device 100 can be configured to deliver modulated signals to at least one or both of the superior root SR and / or branches B1, at least in part based on which of the electrodes 104 are activated. FIG. 4A In the shown inner-outer orientation, the first end 102a and the second end 102b may have the same or at least substantially similar lower-upper positions relative to each other, such that the orientation of, for example, the signal delivery device 100 does not include vector components that are angular in the lower-upper direction.

[0081] refer to FIG. 4B The signal delivery device 100 is at least substantially similar to the previous reference. FIG. 4A The location and orientation described. However, in FIG. 4BIn the anterior-posterior orientation shown, the first end 102a is positioned anterior to the second end 102b such that, for example, the signal delivery device 100 is positioned to deliver a modulatory signal to a motor point MP at which a branch Bl of the cervical plexus AC innervates an upper belly of the omohyoid muscle OHM and an upper portion of the sternohyoid muscle SHM. The motor point MP is the point at which the motor nerve / cervical plexus AC first penetrates the relevant muscle belly, and it is the terminal end of the motor nerve fiber that is the most sensitive location of the muscle to electrical modulation. The motor point MP can include one or more anterior branches AB, each of which innervates individual muscle fibers. One or more of the anterior branches AB can be independently stimulated to elicit a motor response of the corresponding muscle fibers. For example, as shown FIG. 4C As shown, the signal delivery device 100 can be positioned to span / across the anterior branches AB such that various combinations of the electrodes 104 can be activated to deliver a modulatory signal to individual ones of the anterior branches AB. Although described with reference to the omohyoid muscle OHM, one of ordinary skill in the art will appreciate that the cervical plexus AC has motor points MP and anterior branches AB at locations at which it innervates other infrahyoid strap muscles. As a result, one or more signal delivery devices can be positioned to deliver a modulatory signal to one or more of the other motor points.

[0082] Referring to FIG. 4A and FIG. 4B to implant the signal delivery device 100 in these locations and / or orientations, the signal delivery device 100 can be inserted into the patient in a direction from anterior to posterior or in a direction from posterior to anterior. In either case, the first end 102a can lead the second end 102b, or the second end 102b can lead the first end 102a.

[0083] Referring to FIG. 5A , the signal delivery device 100 is in at least a generally inferior-superior orientation and is positioned at least proximate to the superior root SR and / or common branch B3 of the cervical plexus AC. More specifically, the signal delivery device 100 is aligned with an inferior-superior axis such that, for example, when viewed perpendicular to the patient’s sagittal plane, the signal delivery device 100 is positioned superior to the common branch B3 and at least partially behind one or both of the sub-branches B3a, B3b that innervate the sternothyroid muscle. In this position, the signal delivery device 100 can be configured to deliver a modulatory signal to the superior root SR and / or common branch B3 based at least in part on which of the electrodes 104 are activated. In FIG. 5A In the inferior-superior orientation shown, the first end 102a is positioned superior to the second end 102b such that the orientation of the signal delivery device 100 includes a vector component that is aligned with the inferior-superior direction and / or is parallel or at least approximately parallel to the superior root SR.

[0084] Referring to FIG. 5BThe signal delivery device 100 is at least substantially similar to the previous reference. FIG. 5A The location and orientation described. However, in FIG. 5B In the illustrated lower-upper orientation, the first end portion 102a is positioned below the second end portion 102b, such that the orientation of the signal delivery device 100 includes vector components aligned with and / or parallel to or at least substantially parallel to the superior root SR. In this position, the signal delivery device 100 can be configured to deliver modulating signals to one or more of the superior root SR, common branch B3, and / or sub-branches B3a and B3b, respectively innervating the sternothyroid muscle STM and the sternohyoid muscle SHM, based at least in part on which of the electrodes 104 are activated.

[0085] Let's refer to each other. FIG. 5A and FIG. 5B In order to implant the signal delivery device 100 in this location and / or orientation, the signal delivery device 100 can be inserted into the patient in a bottom-to-top or top-to-bottom direction, wherein the first end 102a guides the second end 102b or the second end 120b guides the first end 102a. The signal delivery device 100 is intended to be positioned in... FIG. 5A and FIG. 5B The lower-upper orientation shown has several advantages. For example, because at least a portion of the neck loop is at least substantially parallel to the patient's internal jugular vein (IJV). FIG. 1B The internal jugular vein (IJV) is extended so that practitioners can avoid traversing or puncturing it, while also using the IJV as a navigational landmark to help position the signal delivery device 100 at least near the loop of the neck (AC). Additionally or alternatively, because at least a portion of the loop of the neck (AC) extends in a generally inferior-superior direction, the signal delivery device 100 can be positioned at least generally parallel to the superior-inferior orientation of the loop of the neck without altering or substantially altering the orientation of the signal delivery device 100 during delivery (as previously referenced herein, for example...). FIG. 2C and FIG. 2D (as described).

[0086] FIG. 6A to FIG. 6D A signal delivery device 100 is illustrated, positioned at least near the third branch B3 of the cervical loop nerve AC according to an embodiment of the present technology. Typically, targeting the third branch B3 (and / or one or both of its sub-branches B3a, B3b) is expected to reduce or prevent injury to the internal jugular vein and / or common carotid artery of the patient, at least due to the distance between the third branch B3 and the internal jugular vein and common carotid artery. Additionally or alternatively, targeting the third branch B3 is expected to inhibit or even prevent vagal modulation, at least due to the distance between the third branch B3 and the vagus nerve.

[0087] refer to FIG. 6A, the signal delivery device 100 is positioned at least approximately parallel to the third branch B3 with at least a portion of the signal delivery device 100 positioned medial to the omohyoid muscle OHM. In this position, the electrodes 104 can deliver modulation signals to the third branch B3 and produce a motor response in both the sternohyoid muscle SHM and the sternothyroid muscle STM.

[0088] Referring to FIG. 6B , the signal delivery device 100 is positioned with the electrodes 104 at least partially between the first sub-branch B3a and the second sub-branch B3b of the third branch B3. In this position, the signal delivery device 100 can selectively communicate modulation signals to one or both of the first sub-branch B3a and the second sub-branch B3b to selectively produce a motor response in one or both of the sternohyoid muscle SHM and the sternothyroid muscle STM. For example, individual electrodes of the electrodes 104 can be segmented or masked and configured to deliver modulation signals upwardly / superiorly (e.g., toward the first sub-branch B3a) or downwardly / inferiorly (e.g., toward the second sub-branch B3b).

[0089] Referring to FIG. 6C , the signal delivery device 100 is positioned across (e.g., transverse to) the first sub-branch B3a and the second sub-branch B3b. In this position, various combinations of the electrodes 104 can be activated to selectively deliver modulation signals to one or both of the first sub-branch B3a and the second sub-branch B3b, which can selectively produce a motor response in one or both of the sternohyoid muscle SHM and the sternothyroid muscle STM. In the illustrated embodiment, for example, an electric field can be generated between the lower two electrodes to deliver modulation signals to the second sub-branch B3b and / or an electric field can be generated between the upper two electrodes to deliver modulation signals to the first sub-branch B3a.

[0090] Referring to FIG. 6D , the signal delivery device 100 is positioned along the second sub-branch B3a. In this position, various combinations of the electrodes 104 can be activated to selectively deliver modulation signals to the second sub-branch B3b and / or to the motor end-plate at which the second sub-branch B3b innervates the sternohyoid muscle SHM (e.g., the inferior belly of the sternohyoid muscle SHMi, FIG. 1C ), to selectively produce a motor response in the sternohyoid muscle SHM. In other embodiments, the signal delivery device 100 can be positioned to deliver modulation signals to one or more locations along the length of the cervical loop AC between the starting point of the third branch B3 and the point at which the second sub-branch B3a innervates the sternohyoid muscle SHM.

[0091] FIG. 2A-6DThe position and orientation of the signal delivery device 100 in the foregoing description is generally described with reference to positioning the signal delivery device 100 at least proximate the ansa cervicalis and / or one or more portions and / or branches thereof. In other embodiments, any of the insertion paths described herein (or at least one or more portions thereof) can be used to position the signal delivery device 100 at least proximate one or more other target tissues, such as at least proximate one or more of the infrahyoid strap muscles of the patient. For example, the following references FIG. 7A to FIG. 9B Additional embodiments associated with the infrahyoid strap muscles of the patient are described.

[0092] Generally, modulation signals applied to a nerve (including the ansa cervicalis AC) have a characteristic neuromuscular activation threshold (e.g., minimum amplitude) associated with eliciting a motor response in the tissue innervated by the nerve. Generally, little to no motor response is elicited prior to satisfying the neuromuscular activation threshold. After the neuromuscular activation threshold is satisfied or exceeded, further changes to the modulation signal (e.g., further increases in delivered energy) generally produce little to no additional motor response. This makes it difficult to gradually induce a motor response over time. One approach to addressing this issue is to apply the modulation signal directly to the muscle(s) associated with the motor response of interest. For example, applying a modulation signal directly to one or more of the infrahyoid strap muscles of the patient (e.g., the sternohyoid muscle SHM, the sternothyroid muscle STM, the omohyoid muscle OHM, and / or the thyrohyoid muscle THM) will activate the same muscles as when the modulation signal is applied to one or more portions / branches of the ansa cervicalis AC nerve. This allows for a more gradual dose-response activation by recruiting separate muscle fibers as compared to, for example, activating the nerves / nerve branches that innervate the infrahyoid strap muscles. For example, applying a first modulation signal having one or more first signal delivery parameters (e.g., amplitude, frequency, pulse width, etc.) to the infrahyoid strap muscles at a first point in time can elicit a first motor response, and applying a second modulation signal having one or more second signal delivery parameters different from the one or more first signal delivery parameters to the infrahyoid strap muscles at a second point in time can elicit a second motor response having a different (e.g., greater or lesser) degree, rate, range, and / or amount of movement than the first motor response. In some embodiments, the first signal delivery parameters can include a first amplitude, and the second signal delivery parameters can include a second amplitude greater than the first amplitude, such that delivery of the second modulation signal is expected to produce a greater motor response than delivery of the first modulation signal. Thus, applying a modulation signal directly to the infrahyoid strap muscles is expected to improve the ability to modulate the retraction reflex by increasing control over the elicited patient motor response and / or muscle contraction rate. Increased control over the elicited patient motor response can improve the ability to reduce and / or prevent airway obstruction and / or improve patient comfort and / or treatment compliance.

[0093] Additionally, because the infrahyoid bandgap muscles are larger than the nerves and / or nerve branches that innervate them, it is expected that the infrahyoid bandgap muscles will be easier to identify (e.g., using...). FIG. 2A (Ultrasound probe 201). Unbound by theory, it is believed that the response of the infrahyoid band muscle to directly delivered modulatory signals is less sensitive, at least to the location of the signal delivery device 100 within the infrahyoid band muscle. Therefore, the infrahyoid band muscle can define a larger area (e.g., compared to a nerve) in which the signal delivery device 100 can be positioned to achieve effective results, which is expected to reduce the time associated with identifying and / or implanting the signal delivery device 100. In these and other embodiments, implanting the signal delivery device 100 to deliver modulatory signals to the infrahyoid band muscle is expected to increase the speed at which the signal delivery device 100 can be positioned at least close to the target location by reducing or eliminating the need to identify specific branching patterns of the patient's loop of the neck and then identify (one or more) portions or (one or more) branches of the loop of the neck AC constituting the target location.

[0094] FIG. 7A It is a cross-sectional view of a portion of the patient's neck and jaw, and FIG. 7B This is a lateral cross-sectional view of a portion of the patient's neck and jaw, in which a signal delivery device 100 is implanted in a medial-lateral orientation between the sternohyoid muscle SHM and the sternothyroid muscle STM. In this location, the signal delivery device 100 can deliver a modulating signal to one or both of the sternohyoid muscle SHM and the sternothyroid muscle STM. For example, because the sternohyoid muscle SHM and the sternothyroid muscle STM are close to each other, the electrode 104 can generate an electric field that simultaneously delivers a modulating signal to both the sternohyoid muscle SHM and the sternothyroid muscle STM. In other embodiments, the electrode 104 can be segmented, and each segment carried by the signal delivery device 100 can deliver a modulating signal to one or both of the sternohyoid muscle SHM and the sternothyroid muscle STM.

[0095] Signal delivery device 100 can be used with the previous reference FIG. 2A-3B The described insertion path 210 is at least substantially similar to or identical to the insertion path implanted at this location and orientation. In other embodiments, the signal delivery device 100 may be positioned to deliver modulation signals to the sternohyoid muscle (SHM), omohyoid muscle (OHM), and / or thyrohyoid muscle (THM). In some embodiments, the signal delivery device 100 may have another suitable orientation, such as previously referenced. FIG. 5A and 5B The description is a bottom-to-top orientation.

[0096] FIG. 8is a front cross-sectional view of a portion of a patient's neck and mandible with the signal delivery device 100 positioned at least partially within the sternothyroid muscle STM of the patient. In this position, the signal delivery device 100 is expected to modulate signal delivery to (e.g., only to) the sternothyroid muscle STM without modulating signal delivery to or substantially without modulating signal delivery to other tissue outside of the sternothyroid muscle STM. In some embodiments, the signal delivery device 100 can be positioned completely within the sternothyroid muscle STM, and / or the signal delivery device can be positioned at least partially or completely within one or more of the sternohyoid muscle SHM, the omohyoid muscle OHM, the thyrohyoid muscle THM, and / or another muscle in the patient's neck and / or mandible.

[0097] FIG. 9A is a side cross-sectional view of a portion of a patient's neck and mandible anatomy including the ansa cervicalis AC, the omohyoid muscle OHM, the sternohyoid muscle SHM, the sternothyroid muscle STM, and the thyrohyoid muscle THM. FIG. 9A The hypoglossal nerve HGN of the patient is additionally shown including the medial branch MB of the hypoglossal nerve HGN and the anterior branch AB of the hypoglossal nerve HGN. The anterior branch AB can include distal arborizing portions of the HGN such as motor points, motor endplates, and / or neuromuscular junctions where the HGN inserts into the genioglossus muscle GG. In some patients, one or more of the anterior branch AB can include a plurality of distal arm portions DB that innervate the genioglossus muscle GG of the patient. By positioning and activating a minimally invasive electrode in the vicinity of the aforementioned neural structures and / or associated muscle tissue, embodiments of the present technology can control, reduce, and / or eliminate the effects of OSA. Further details regarding the anterior branch AB can be found in U.S. Application No. 18 / 393,537, filed December 21, 2023, the entirety of which is incorporated by reference herein.

[0098] FIG. 9B is a side cross-sectional view of a portion of a patient's neck and mandible anatomy including the ansa cervicalis AC, the omohyoid muscle OHM, the sternohyoid muscle SHM, the sternothyroid muscle STM, and the thyrohyoid muscle THM. FIG. 1D The first signal delivery device 900a and the second signal delivery device 900b can be implanted as part of the same procedure, or one of the first signal delivery device 900a and the second signal delivery device 900b can be implanted at some time after the other of the first signal delivery device 900a and the second signal delivery device 900b is implanted.

[0099] The first signal delivery device 900a can be positioned to deliver the modulation signal to a first target tissue, and the second signal delivery device 900b can be positioned to deliver the modulation signal to a second target tissue different from the first target tissue. For example, in the illustrated embodiment, the first signal delivery device 900a is positioned to deliver one or more first modulation signals to the anterior branch AB of the hypoglossal nerve HGN, and the second signal delivery device 900b is positioned to deliver one or more second modulation signals to the third branch B3 of the ansa cervicalis AC. In some embodiments, the first signal delivery device 900a is implanted after the second signal delivery device 900b based at least in part on a determination that modulation of the ansa cervicalis AC alone is insufficient to address the patient’s respiratory obstruction. In other embodiments, the second signal delivery device 900b is implanted after the first signal delivery device 900a based at least in part on a determination that modulation of the hypoglossal nerve HGN alone is insufficient to address the patient’s respiratory obstruction.

[0100] The first signal delivery device 900a and / or the second signal delivery device 900b can have other suitable positions. For example, the first signal delivery device 900a can be positioned to deliver the first modulation signal to any one or more of: the medial branch MB of the hypoglossal nerve HGN, directly to the geniohyoid muscle GG, 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 another target location described herein for addressing OSA of the patient. Additionally or alternatively, the second signal delivery device 900b can be positioned to deliver the second electrical signal 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, directly to the geniohyoid muscle GG, 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 for addressing OSA of the patient. In these and / or other embodiments, the first signal delivery device 900a and the second signal delivery device 900b can be positioned to bilaterally stimulate corresponding tissues on the left and right sides of the patient, e.g., the left hypoglossal nerve and the right ansa cervicalis nerve, the left thyrohyoid muscle and the right geniohyoid muscle, etc.

[0101] The first and second signal delivery devices 900a, 900b 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, for example, 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 physiological input from an external wearable device or another device configured to detect the patient's airway flow response. Additionally or alternatively, one or more of the signal delivery parameters of the modulation signals delivered by the first and second signal delivery devices 900a, 900b can vary based at least in part on the respective locations and / or target tissue of the first and second signal delivery devices 900a, 900b. For example, in the case of the first and second single delivery devices 900a, 900b positioned as shown in FIG. 9A, the first and second single delivery devices 900a, 900b can be programmed to deliver respective modulation signals having different pulse widths, e.g., the first signal delivery device 900a has a pulse width of about 100 μβ and the second signal delivery device 900b has a pulse width of about 50 μβ. FIG. 9B

[0102] In some embodiments, one or more of the signal delivery parameters of the modulation signal delivery by the first and / or second signal delivery devices 900a, 900b can be adjusted or modulated during delivery, e.g., in a closed loop or open loop manner. For example, the adjustment / modulation of the signal delivery parameters can compensate for movement of one or both of the signal delivery devices 900a, 900b relative to their respective target locations after implantation, which can be caused by movement of the patient and / or one or more changes in the patient's body position. In addition, the adjustment / modulation of the signal delivery parameters can compensate for one or more changes in the patient's sleep stage, data associated with the efficacy of the modulation therapy (e.g., airflow, respiratory effort), etc.

[0103] ​In some embodiments, the first signal delivery device 900a and the second signal delivery device 900b can be independently activated such that one of the first signal delivery device 900a and the second signal delivery device 900b can be active while the other of the first signal delivery device 900a and the second signal delivery device 900b is inactive. Each of the first signal delivery device and the second signal delivery device can independently alternate between active / on and inactive / off states for a selected time period, such as a very short duration (e.g., 100 milliseconds) or a longer duration (e.g., 10 seconds). For example, in some embodiments, an ON-OFF modulation pattern can be programmed to regularly alternate between the first signal delivery device 900a and the second signal delivery device 900b. For example, the first signal delivery device 900a can be on (e.g., receive power and / or deliver a modulation signal) 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 900b 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 900a can be off (e.g., not receive power and / or not deliver a modulation signal) when the second signal delivery device 900b is on and / or vice versa, and / or the delivery of a modulation signal can be concurrent for a portion of the modulation pattern. In other embodiments, both the first signal delivery device 900a and the second signal delivery device 900b can be on and off at the same or at least approximately the same time. In further embodiments, the times at which a given signal delivery device 900a, 900b is on or off can be random. In some embodiments, after at least one of the first signal delivery device 900a and the second signal delivery device 900b has completed an on interval, the first signal delivery device 900a and / or the second signal delivery device 900b 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.

[0104] In some embodiments, individual electrodes carried by the first signal delivery device 900a and the second signal delivery device 900b can be activated or deactivated to direct the delivery of a modulation signal toward a respective target location and / or adjust the generated electric field to deliver the modulation signal (e.g., to narrow or widen the electric field). In the illustrated embodiments, for example, the first signal delivery device 900a and the second signal delivery device 900b include a four-pole electrode array 904a, 904b, each electrode array having four electrodes 904a 1-4 , 904b 1-4. The second electrode 904a 2,3 and the third electrode 904b 2,3 may produce a narrower field than, for example, the first electrode 904a 1,4 and the fourth electrode 904b 1,4 . In some embodiments, the second electrode 904a2 and the third electrode 904a3 of the first signal delivery device 900a can be activated, and the first electrode 904b1 and the fourth electrode 904b4 of the second signal delivery device 900b can be activated, such that the first signal delivery device 900a generates a relatively narrow field and the second signal delivery device 900b generates a relatively wide field. In other embodiments, any other combination of electrodes 904a 1-4 , 904b 1-4 may be activated.

[0105] In some embodiments, the cycling modulation pattern can be programmed to regularly alternate one or more parameters of the signals delivered by the first signal delivery device 900a and the second signal delivery device 900b. The amplitude, pulse width, and / or frequency can be programmed to change regularly at programmed time intervals, in response to sensed data, randomly, irregularly, etc. For example, the first signal delivery device 900a can be set to 1.0 mA for 1 second, then 2.0 mA for 1 second, and then 1.0 mA for 1 second, for a 3 second duration of the modulation. The second signal delivery device 900b can be set to 0.5 mA for 1 second, then 1.0 mA for 1 second, and then 0.5 mA for 1 second, for a 3 second duration of the modulation. In some embodiments, the amplitudes of these patterns can be reversed relative to one another. The first signal delivery device 900a and the second signal delivery device 900b can deliver their respective modulation signals at the same or different times, and / or can deliver the modulation signals concurrently for a portion of the modulation pattern.

[0106] In some embodiments, the IF-THEN modulation pattern can be programmed to be responsive to one or more particular physiological measurements (e.g., air flow) detected or determined by, for example, one or more sensors of the signal delivery devices, one or more sensors implanted in the patient, and / or a wearable or other external sensing device. For example, one of the first signal delivery device 900a and the second signal delivery device 900b can be turned on by a wearable device. If the patient’s physiological response is insufficient, as determined based at least in part on one or more physiological measurements, then the other of the first signal delivery device 900a and the second signal delivery device 900b can be turned on, such that both the first signal delivery device 900a and the second signal delivery device 900b are operating simultaneously. Additionally or alternatively, one or more parameters of the respective signals delivered by the first signal delivery device 900a and the second signal delivery device 900b can be adjusted (e.g., as described herein) in response to one or more of the physiological measurements.

[0107] In some embodiments, the first signal delivery device 900a and the second signal delivery device 900b can be programmed with a phase manipulation pattern. For example, the amplitude of the modulation signal delivered by the first signal delivery device 900a can be ramped up and down in a sinusoidal waveform shape during the modulation interval. The modulation signal delivered by the second signal delivery device 900b can have a similar amplitude shape, and can have a phasing pattern that is in phase or 180 degrees out of phase with the modulation signal of the first signal delivery device. In at least some embodiments, the first signal delivery device 900a and / or the second signal delivery device 900b can be programmed to create a phase inversion via their respective delivery of modulation signals. In some embodiments, the modulation signals can be square waves, and can be ramped in a stepwise fashion, for example, from a first pulse to a second pulse.

[0108] 4. Representative experimental data

[0109] FIG. 10A A plot of patient data obtained by directing modulation signals to the patient’s cervical sling nerve is shown in accordance with several embodiments of the present technology. Specifically, FIG. 10A A plot of respiratory impedance plethysmography (“RIP”) 1020, CPAP mask pressure 1022, air flow 1024, and cervical sling modulation 1026 signals during a plurality of signal delivery periods 1028 (individually identified as a first signal delivery period 1028a, a second signal delivery period 1028b, and a third signal delivery period 1028c) and a post-signal delivery period 1029.

[0110] To obtain these data, the patient was equipped with electroencephalography, electrooculography, submental chin electromyography, epiglottic pressure sensor, and a sealed nasal mask and pneumotachograph to quantify airflow. After propofol sedation, the patient's glossopharyngeal nerve was identified using ultrasound to guide placement of a percutaneous electrode array in a position and / or orientation at least approximately similar to that shown in the embodiment illustrated in FIG. 1. The electrode array used during this test included four electrical contacts (hereinafter referred to as electrode #1, electrode #2, electrode #3, and electrode #4) arranged in series. An endoscope was inserted via the patient's nose to visualize changes in the patient's airway size and shape during periods when modulatory signals were delivered to the distal branch via the electrode array. A modified CPAP device was used to deliver therapeutic CPAP and transient pressure reductions to induce airflow restriction / closure in a manner that simulates the way in which a sleep disordered breathing patient experiences respiratory obstruction. FIG. 6D

[0111] During the post-signal delivery period 1029, the pressure within the patient's airway returned to normal levels, as shown by the changes in the RIP plot 1020 and the CPAP mask pressure plot 1022, and the electrode array was inactive (i.e., no modulatory signals were delivered to the patient's glossopharyngeal nerve). Outside of the signal delivery periods 1028, the RIP plot 1020, the CPAP mask pressure plot 1022, and the airflow plot 1024 show that the patient's breathing was obstructed with respect to the decrease in the post-signal delivery period 1029.

[0112] During each signal delivery period 1028, a modulatory signal was directed to the glossopharyngeal nerve from an electrode array positioned in accordance with an embodiment of the present technology. Specifically, during the first signal delivery period 1028a, a 1 mA bipolar modulatory signal was delivered to the glossopharyngeal nerve with electrode #1 acting as the cathode and electrode #3 acting as the anode. The 1 mA modulatory signal did not substantially increase or otherwise improve the patient's airflow, as shown by the patient's airflow plot 1024 before, during, and after the first signal delivery period 1028a. This is further supported by the RIP plot 1020 and the CPAP mask pressure plot 1022, which remained substantially unchanged during the first signal delivery period 1028a.

[0113] ​During the second signal delivery period 1028b, a 1.5 mA bi-polar modulation signal is delivered to the neck loop with electrode #1 acting as the cathode and electrode #3 acting as the anode. The 1.5 mA modulation signal increases the patient's airflow, as shown by the corresponding change in the airflow graph 1024 during the second signal delivery period 1028b, but this change does not fully restore the patient's airflow. In other words, the 1.5 mA signal produces a beneficial, but sub-maximal, flow response. This change in the patient's airflow is further demonstrated by the corresponding changes in the RIP graph 1020 and the CPAP mask pressure graph 1022 during the second signal delivery period 1028b.

[0114] During the third signal delivery period 1028c, a 2 mA modulation signal is delivered to the neck loop with electrode #1 acting as the cathode and electrode #3 acting as the anode. The 2 mA modulation signal increases the patient's airflow, as shown by the corresponding change in the airflow graph 1024 during the third signal delivery period 1028c. In comparison to the 1.5 mA modulation signal delivered during the second signal delivery period 1028b, the 2 mA modulation signal produces a greater increase in the patient's airflow, thereby fully restoring the patient's airflow to normal or pre-obstruction levels. This change in the patient's airflow is further evidenced by the corresponding changes in the RIP graph 1020 and the CPAP mask pressure graph 1022 during the third signal delivery period 1028c.

[0115] During the fourth signal delivery 1028d, a 0.5 mA modulation signal is delivered to the neck loop with electrode #2 acting as the cathode and electrode #4 acting as the anode. The 0.5 mA modulation signal does not substantially increase or otherwise improve the patient's airflow, as shown by the patient's airflow graph 1024 before, during, and after the fourth signal delivery period 1028d. This is further supported by the RIP graph 1020 and the CPAP mask pressure graph 1022, which remain substantially unchanged during the fourth signal delivery period 1028d.

[0116] During the fifth signal delivery period 1028e, a 1.5 mA bipolar modulating signal is delivered to the cervical loop with electrode #2 acting as the cathode and electrode #4 acting as the anode. The 1.5 mA modulating signal increases the patient's airflow, as shown by the corresponding change in the airflow graph 1024 during the fifth signal delivery period 1028e, but this change does not fully restore the patient's airflow. In other words, the 1.5 mA signal produces a beneficial but sub-maximal flow response. This change in patient airflow is further demonstrated by the corresponding changes in the RIP graph 1020 and the CPAP mask pressure graph 1022 during the fifth signal delivery period 1028e. However, the increase in airflow during the fifth signal delivery period 1028e is approximately equal to the increase in airflow elicited in response to another 1.5 mA modulating signal during the second signal delivery period 1028b.

[0117] During the sixth signal delivery period 1028f, a 2 mA bipolar modulating signal is delivered to the cervical loop with electrode #2 acting as the cathode and electrode #4 acting as the anode. While the 2 mA modulating signal delivered via electrodes #1 and #3 during the third signal delivery period 1028c fully restores the patient's airflow, the 2 mA modulating signal delivered via electrodes #2 and #4 during the sixth signal delivery period 1028f increases the patient's airflow to a level that is less than full airflow restoration (see the corresponding change in the airflow graph 1024 during the sixth signal delivery period 1028f). In other words, the 2 mA signal delivered via electrodes #2 and #4 during the sixth signal delivery period 1028f produces a beneficial but sub-maximal flow response. This change in patient airflow is further demonstrated by the corresponding changes in the RIP graph 1020 and the CPAP mask pressure graph 1022 during the sixth signal delivery period 1028f. Thus, given the particular location of the electrode array relative to the cervical loop, selecting one or more combinations of the bipolar electrode arrangements can produce superior results (e.g., using electrode #1 as the cathode and electrode #3 as the anode can be a better lead configuration than using electrode #2 as the cathode and electrode #4 as the anode in this particular location of the electrode array).

[0118] During the post-signal delivery period 1029, the pressure within the patient's airway returns to normal levels, as shown by the changes in the RIP graph 1020 and the CPAP mask pressure graph 1022, and the electrode array is inactive (i.e., no modulating signal is delivered to the patient's cervical loop). Thus, the airflow graph 1024 during the post-signal delivery period 1029 represents the patient's normal breathing behavior. Comparing the airflow graph 1024 during the third signal delivery period 1028c to the post-signal delivery period 1029 further illustrates that the 2 mA modulating signal delivered during the third signal delivery period 1028c fully restores the patient's airflow.

[0119] These data show that delivery of modulating signals from electrode arrays positioned in accordance with embodiments of the technology to the loop nerves of the neck elicit patient motor responses (e.g., tail pull) to restore airflow. In addition, although the patient was sedated during this test, the inventors observed that the data indicate that the patient is less likely to be awakened from sleep if modulating signals, such as those delivered during signal delivery period 1028, are delivered to the patient while the patient is sleeping. Several of the amplitudes used during signal delivery period 1028 were lower than amplitudes used to stimulate the hypoglossal nerve and produce a corresponding increase in patient airflow (e.g., about 2 mA to about 4 mA), such as at least FIG. 12 Described to FIG. 15, the entirety of this application is incorporated herein by reference. Thus, without being bound by theory, it is believed that the relatively lower amplitude signals delivered to the loop nerves of the neck are expected to reduce or completely prevent the rate of patient awakening, while also addressing breathing obstruction by at least increasing or even completely restoring patient airflow. In some embodiments, the lower amplitudes associated with loop of the neck modulation are expected to reduce the amount of power transmitted to one or more implanted devices positioned to deliver modulating signals to the loop nerves of the neck as compared to the power transmission requirements of one or more implanted devices positioned to deliver modulating signals to the hypoglossal nerve. However, in these and / or other embodiments, it is expected that the use of hypoglossal nerve modulation as a secondary modulating location and / or the use of hypoglossal nerve modulation in addition to the loop nerves of the neck will improve (e.g., further improve) patient airflow.

[0120] FIG. 10B Table 1 is a table including data obtained by positioning and activating signal delivery devices in accordance with embodiments of the technology. The signal delivery devices were positioned to stimulate the loop nerves of the neck of subject 1, subject 4, and subject 5 using a medial-to-lateral approach, as previously referenced herein with respect to FIG. 2A Table 2 is a table including data obtained by positioning and activating signal delivery devices in accordance with embodiments of the technology. The signal delivery devices were positioned to stimulate the loop nerves of the neck of subject 1, subject 4, and subject 5 using a medial-to-lateral approach, as previously referenced herein with respect to FIG. 2AThe signal delivery devices were positioned to stimulate the glossopharyngeal nerve of subjects 2, 3, 5, 6, and 7 using a lateral-to-medial approach. As shown by the VOTE (“Velum, Oropharynx, Tongue, Epiglottis”) scores in this table, subjects 1-7 had recorded tissue collapse at different locations (e.g., velum / post-velum, oropharynx, tongue base / post-tongue, and / or epiglottis / post-epiglottis) and various types (e.g., anterior-posterior (A / P), concentric, and / or lateral-lateral (L / L)) before and after modulation. Despite differences in how the breathing obstructions of these subjects presented physiologically, delivering modulation signals of various amplitudes (e.g., in a range of amplitudes between about 0.5 mA and about 5 mA) produced at least an 80% increase in peak airflow amplitude, and most subjects experienced more than a 100% increase in peak airflow amplitude. In addition, subjects 2-4 experienced tongue base collapse, which is traditionally addressed by stimulating the hypoglossal nerve. However, modulating the glossopharyngeal nerve of subjects 2-4 according to embodiments of the technology significantly increased the airflow of these subjects. It is believed that modulating the glossopharyngeal nerve in the context of what was performed on subjects 2-4 surprisingly caused their tongue bases to move down, thereby reducing tongue base collapse, while also stiffening the airway through caudal traction. This resulted in a surprising large increase in airflow for subjects 2-4. This is even more surprising because, as referenced previously herein, the glossopharyngeal nerve is not traditionally associated with tongue base collapse or hypoglossal nerve stimulation. FIG. 1A The inventors observed that reducing the hyoid bone through modulation of the glossopharyngeal nerve to produce caudal traction produces a corresponding movement of the tongue base, which in at least some cases can reduce or even eliminate tongue base collapse.

[0121] FIG. 10C is a graph showing the recovery of airflow for all subjects listed in the table of FIG. 10B As shown, the various modulation signals described above significantly improved the airflow of the subjects. Most subjects exhibited airflow levels associated with hypopnea before and after modulation, but during modulation, their airflow levels increased to ranges associated with snoring. Subjects 2 and 3 experienced an increase in airflow levels to levels associated with no breathing obstruction. The airflow of subject 7 increased from levels associated with complete apnea (e.g., little to no airflow) before modulation to levels associated with snoring during modulation. The inventors did not expect that delivering modulation to the glossopharyngeal nerve alone would produce this magnitude of increase in airflow.

[0122] FIG. 10A-10CThe data in FIG. 10B indicates that delivery of a modulating signal to the hypoglossal nerve from an electrode array positioned in accordance with embodiments of the technology causes a patient motor response (e.g., tail pull) to restore airflow. Additionally, no signs of patient arousal were observed during the signal delivery period 1028. The amplitude used during the signal delivery period 1028 was lower than the amplitude used to stimulate the hypoglossal nerve and produce a corresponding increase in patient airflow (e.g., about 2 mA to about 4 mA), such as described with reference to U.S. Application No. 18 / 393,537. Thus, in some embodiments, the relatively low amplitude of the signal delivered to the hypoglossal nerve is expected to reduce or completely prevent patient arousal rates while also addressing respiratory obstruction by at least increasing or even completely restoring patient airflow. In some embodiments, the lower amplitude associated with hypoglossal modulation is expected to reduce the amount of power transmitted to one or more implanted devices positioned to deliver a modulating signal to the hypoglossal nerve as compared to the power transmission requirements of one or more implanted devices positioned to deliver a modulating signal to the hypoglossal nerve. However, in these and / or other embodiments, hypoglossal nerve modulation is expected to be used as an adjunct and / or in addition to modulation sites of the hypoglossal nerve to improve (e.g., further improve) patient airflow. FIG. 12 To FIG. 15, the entirety of which is incorporated herein by reference. Thus, without being bound by theory, it is believed that the relatively low amplitude of the signal delivered to the glossopharyngeal nerve is expected to reduce or completely prevent patient arousal rates while also addressing respiratory obstruction by at least increasing or even completely restoring patient airflow. In some embodiments, the lower amplitude associated with glossopharyngeal modulation is expected to reduce the amount of power transmitted to one or more implanted devices positioned to deliver a modulating signal to the glossopharyngeal nerve as compared to the power transmission requirements of one or more implanted devices positioned to deliver a modulating signal to the glossopharyngeal nerve. However, in these and / or other embodiments, glossopharyngeal nerve modulation is expected to be used as an adjunct and / or in addition to modulation sites of the glossopharyngeal nerve to improve (e.g., further improve) patient airflow.

[0123] Although certain modulation amplitudes are described above with reference to FIG. 10A and 10B In other embodiments, additional and / or other modulation amplitudes can be delivered to the glossopharyngeal nerve, the hypoglossal nerve, and / or one or more other target tissues described herein. In some embodiments, the modulation amplitudes can be based at least in part on one or more modulation thresholds associated with the corresponding target tissue. Generally, for a given nerve, the modulation threshold is the modulation level (e.g., amplitude) at which further increases in modulation do not produce an increase in patient airflow response. This is because modulation at the modulation threshold produces a full muscle response (e.g., full contraction and / or tetanic response of one or more muscles innervated by the glossopharyngeal nerve), and thus, modulation at levels above the modulation threshold cannot produce further muscle response beyond the already full muscle response.

[0124] As FIG. 10AAs shown in FIG. 10B, increasing the amplitude of the modulation signal from 1.5 mA during the second signal delivery period 1028b to 2 mA during the second signal delivery period 1028c results in a corresponding increase in the patient's airflow. Thus, because increasing the amplitude beyond 1.5 mA results in an increase in the patient's airflow, it is expected that the jugular ansa has a modulation threshold greater than 1.5 mA. In other words, the 1.5 mA modulation signal is a subthreshold signal that is less than the modulation threshold. The modulation threshold for this patient and / or other patients can vary based at least in part on the proximity of the electrode array to the jugular ansa nerve and / or the location of the electrode array along the jugular ansa nerve. Delivering one or more modulation signals to the jugular ansa at an amplitude in the subthreshold range is expected to not result in a full muscle response (e.g., a full contraction and / or a tetanic response of one or more muscles innervated by the jugular ansa nerve). Rather, delivering a modulation signal to the jugular ansa at a subthreshold amplitude is expected to cause one or more of the muscles innervated by the jugular ansa nerve to stiffen or tighten and improve airflow, which makes it less likely that these tissues will occlude the patient's breathing and / or at least less likely to further occlude the patient's breathing without inducing a full muscle contraction or tetanic response.

[0125] In some aspects of the technology, subthreshold amplitudes can restore one or more tissues of the patient's airway to a more natural condition (e.g., closer to the muscle tone (stiffness) of similar healthy patient tissues) and / or allow the patient to breathe in a more natural manner as compared to threshold or suprathreshold modulation amplitudes. For example, as described above, threshold or suprathreshold modulation amplitudes are expected to fully contract the muscles innervated by the jugular ansa nerve. The resulting sensory experience for the patient is generally uncomfortable and greatly different from natural breathing, and it can cause arousal. Moreover, a full muscle contraction can not be needed to sufficiently improve the patient's airflow or otherwise adequately address their breathing obstruction. One or more muscles that contract in response to modulation can also be selected to allow the patient to breathe in a more natural manner during modulation. For example, many patients are accustomed to the experience of their stylohyoid muscles SHM and / or thyrohyoid muscles STM being maximally contracted during an inhalation period (e.g., during a yawn). However, many patients are not accustomed to the experience of their genioglossus muscle GG being maximally contracted, as this does not regularly occur during inhalation. Thus, it is expected that delivering a modulation signal that causes contraction of the stylohyoid muscles SHM and / or thyrohyoid muscles STM will be less likely to arouse the patient from sleep and / or otherwise cause the patient discomfort as compared to a modulation signal that causes contraction of the genioglossus muscle.

[0126] Stiffening the tissues that define the patient's airway without producing a full muscle contraction can improve the patient's breathing without or substantially without causing discomfort (e.g., arousal). For example, as described above, a full muscle contraction is expected to cause the patient to experience a sensation of discomfort and / or arousal. However, a subthreshold amplitude is expected to cause the patient to experience a sensation of improved airflow and / or a sensation of the patient's airway being less obstructed without causing the patient to experience a sensation of discomfort and / or arousal. Thus, in some aspects of the technology, a subthreshold amplitude is expected to improve the patient's breathing without or substantially without causing the patient to experience a sensation of discomfort and / or arousal. FIG. 10AAs shown in FIG. 10B, the sub-threshold 1.5 mA adjustment signal delivered during the second signal delivery period 1028b improves the patient's airflow. Although this 1.5 mA adjustment signal does not fully restore the patient's airflow, it is advantageous to deliver adjustment signals at sub-threshold amplitudes. For example, at least some sub-threshold amplitudes are below the patient's perception threshold and / or arousal threshold. The perception threshold is the level of adjustment (e.g., amplitude) at which the patient can perceive or sense (e.g., while awake or conscious) that they are receiving an adjustment signal. This is often because the patient can perceive or sense a muscle or motor response induced by the adjustment signal. The arousal threshold is the level of adjustment (e.g., amplitude) that causes the patient to arouse or wake from sleep. This means that sub-threshold amplitudes are less likely to cause the patient discomfort or to arouse the patient from sleep, making these amplitudes more comfortable than threshold or supra-threshold amplitudes.

[0127] Adjustment response data, e.g., FIG. 10A and 1BThe data shown in FIG. 10B can be used to tailor treatment for a given patient. For example, at least some embodiments of the present technology include determining a patient’s perception threshold and / or arousal threshold, and delivering one or more modulation signals at a level (e.g., amplitude) that is less than the patient’s perception threshold and / or arousal threshold. Determining a patient’s perception threshold can involve delivering modulation signals at a plurality of (e.g., progressively increasing) amplitudes and asking the patient which of the modulation signals they can perceive. Determining a patient’s arousal threshold can involve delivering modulation signals at a plurality of (e.g., progressively increasing) amplitudes while the patient is asleep to determine which amplitudes arouse the patient. Many patients tolerate higher levels of modulation while asleep (and generally do not consciously perceive such modulation because they are asleep). Thus, many patients have (or are expected to have) a higher arousal threshold than their perception threshold. In some embodiments, determining a patient’s perception threshold and / or arousal threshold can include determining or quantifying a patient’s response to a delivered modulation signal. For example, determining a patient’s response can include calculating the patient’s AHI and / or generating a dose-response curve plotting AHI against modulation amplitude. A patient’s determined response to a plurality of modulation signals can be used to identify which modulation signal level provides a sufficient or optimal patient response. For example, a patient’s determined response to a modulation signal can be used to determine which modulation signal provides a sufficient improvement in airflow or other respiratory activity while reducing or minimizing patient discomfort. In at least some embodiments, a delivered sub-threshold modulation signal can have an amplitude that is 1%, 5%, 10%, 15%, 20%, 25%, 30%, 40%, 50%, 60%, 70%, 75%, 80%, 90%, or 99% of the perception threshold and / or arousal threshold. Delivering one or more modulation signals at a sub-threshold level can stiffen and / or move one or more tissues defining a patient’s airway and improve the patient’s breathing without producing a full muscle contraction and without or substantially without causing discomfort (e.g., arousal), as previously described herein. In some embodiments, delivering one or more modulation signals at a sub-threshold level includes delivering one or more modulation signals determined using the dose-response curve described above.

[0128] In some embodiments, the present technology includes selecting an electrode pair to deliver one or more modulation signals based at least in part on a patient’s modulation response data. Selecting an electrode pair can include delivering one or more modulation signals via different electrode combinations and determining which electrode pair produces the best or optimal results. For example, as shown in FIG. 10B, the patient responded better to a first 2 mA modulation signal delivered via the #1 and #3 electrodes during the third signal delivery period 1028c than to a second 2 mA modulation signal delivered via the #2 and #4 electrodes during the sixth signal delivery period 1028f. Thus, the #1 and #3 electrodes can be selected for use during further trials and / or long-term use. FIG. 10A As shown in FIG. 10B, the patient responded better to a first 2 mA modulation signal delivered via the #1 and #3 electrodes during the third signal delivery period 1028c than to a second 2 mA modulation signal delivered via the #2 and #4 electrodes during the sixth signal delivery period 1028f. Thus, the #1 and #3 electrodes can be selected for use during further trials and / or long-term use.

[0129] While the subthreshold modulation concept is described above with reference to amplitude, in these and / or other embodiments, other modulation parameters can be adjusted to provide subthreshold modulation. In at least some embodiments, for example, in addition to or instead of adjusting amplitude, the pulse width of the modulation delivered to the patient can be adjusted to provide subthreshold modulation. If the modulation signal delivered to the patient equals or exceeds the modulation and / or perception threshold of that patient, the pulse width of the modulation signal can be increased and / or the amplitude of the modulation signal can be decreased until, for example, the modulation signal is below the modulation and / or perception threshold. The amplitude, pulse width, and / or one or more other modulation parameters (e.g., frequency, duty cycle, interpulse interval, etc.) can be adjusted manually (by, for example, a user) or automatically.

[0130] 5. Additional apparatus, systems, and methods

[0131] FIG. 11 is a block diagram illustrating elements of a system 1130 for treating sleep disorders according to embodiments of the present technology. The system 1130 can include a wearable device 1132, a charger 1134, one or more implants or signal delivery devices (e.g., first signal delivery device 1100a, second signal delivery device 1100b,... Nth signal delivery device 1200n, collectively “signal delivery devices 1100”), and a connected device or programmer 1136. Generally, the programmer 1136 can send instructions for generating modulation signals (e.g., signal delivery or waveform parameters) to the wearable device 1132, the wearable device 1132 can send the instructions and power to the signal delivery device(s) 1100, and the individual signal delivery devices 1100 can generate modulation signals according to the sent instructions and apply the modulation signals to a patient via electrodes carried by the signal delivery device(s) 1100. One or more of the signal delivery devices 1100 can be at least generally similar or identical in structure and / or function to the signal delivery device 100 of FIG. 1D Additionally, one or more of the signal delivery devices 1100 can be implanted in a patient using one or more of the insertion paths previously described with reference to FIG. 2A-9B Additionally, one or more of the signal delivery devices 1100 can be implanted in a patient using one or more of the insertion paths previously described with reference to FIG. 2A-9B Additionally, one or more of the signal delivery devices 1100 can be implanted in a patient using one or more of the insertion paths previously described with reference to FIG. 2A-9B Additionally, one or more of the signal delivery devices 1100 can be implanted in a patient using one or more of the insertion paths previously described with reference to

[0132] The programmer 1136 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 signals delivered to the patient. In representative embodiments, the programmer 1136 can include a therapy adjustment module configured to select one or more of the electrodes carried by the signal delivery device(s) 1100, and to adjust the amplitude, frequency, pulse width, burst duration, whether an electrode is active or inactive, and / or any other suitable signal delivery parameter. Additionally, the programmer 1136 can synthesize information received from a user, the wearable device 1132, and / or the signal delivery device(s) 1100 (e.g., diagnostic and / or feedback information), and can adjust one or more signal delivery parameters based at least in part on the synthesized information. For example, the programmer 1136 can be configured to receive one or more inputs corresponding to the patient’s perception threshold and / or arousal threshold, and to adjust the amplitude of the modulation signals delivered to the patient based at least in part on the patient’s perception threshold and / or arousal threshold. Additionally or alternatively, the programmer 1126 can generate a dose-response curve plotting AHI against modulation amplitude as previously described herein, and use the dose-response curve to adjust or recommend adjustments to the amplitude of the modulation signals delivered to the patient.

[0133] The programmer 1136 can transmit signal delivery parameters to the signal delivery device(s) 1100 directly and / or via the wearable device 1132. For example, the programmer 1136 can connect to the signal delivery devices 1100 and / or individual ones of the signal delivery devices 1100 and / or the wearable device 1132 via a wired or wireless communication link, such as WiFi, Bluetooth (“BT”), cellular connectivity, and / or any other suitable communication link. In these and other embodiments, the programmer 1136 can connect to the cloud 1138 and / or other computer services, for example, to upload data received from the sensors of the wearable device 1132 and / or to download information to the wearable device 1132 and / or the signal delivery device(s) 1100. In these and other embodiments, the programmer 1136 can include a display and / or a user interface. A user (e.g., a patient, a clinician, and / or other suitable user) can interact with and / or otherwise control one or more aspects of the programmer 1136 via the user interface, for example, to manually adjust one or more of the signal delivery parameters, to read data received from the sensors of the wearable device 1132, to provide one or more inputs corresponding to an organization collapse pattern, and / or to perform other tasks.

[0134] The wearable device 1132 can include a collar, chin strap, mouthpiece, pillow, and / or can have other suitable form factors. The wearable device 1132 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 a patient can include a respiratory rate, a sleep state, an arousal state, a heart rate, an audio signal (corresponding to audible snoring, a hypopnea event, and / or an apnea event), a body temperature, a head orientation / position, a saturation blood oxygen level, an airflow level, a laryngeal movement, a tracheal movement, and / or a tongue movement, photoplethysmography (PPG) data, and / or the like, each of which can be received by a respective type of sensor (e.g., heart rate data from a heart rate sensor, head orientation / position data from an accelerometer, and / or the like). This data can be received via one or more respective sensors (e.g., a body temperature from a temperature sensor, an audio signal from a microphone or other audio sensor, and / or the like), and can correspond to a measure of a patient’s respiratory performance, sleep state, arousal state, and / or other suitable metrics, e.g., metrics used to rate a patient according to an apnea-hypopnea index (AHI). Additionally or alternatively, the wearable device 1132 can receive data from the individual signal delivery device 1100, e.g., using backscatter, pulse width modulation, frequency modulation, and / or one or more other suitable techniques. For example, the signal delivery device 1100 can send a receipt to indicate that power has been received, as well as an amplitude of the power. This information can be used to automatically adjust (up or down) an output of a pulse generator of the signal delivery device, e.g., a transmitted signal and phase.

[0135] The wearable device 1132 can also include a power source (e.g., a storage power device such as a battery), one or more power transmitting devices configured to transmit power and / or signal delivery parameters to the signal delivery device(s) 1100, and one or more algorithms configured to control one or more aspects of the operation of the wearable device 1132. Individual ones of the sensors can collect data associated with a patient, such as a sleep state and / or respiratory performance of the patient. The one or more algorithms can be configured to adjust at least one of the signal delivery parameters based at least in part on the data collected by the sensors. In representative embodiments, the wearable device 1132 can include an integrated sleep, respiratory diagnostic, and / or therapy adjustment system configured to adjust or otherwise control one or more delivery parameters of an adjustment signal delivered to a patient based on collected sleep state and / or respiratory performance data (e.g., via one or more algorithms).

[0136] In some embodiments, the wearable device 1132 can also include a cover or housing, at least a portion of which can be removable, e.g., to expose an interior or interior portion of the wearable device 1132. In these and other embodiments, the wearable device 1132 cover can include fabric or any other suitable material. Optionally, the wearable device 1132 can include a reduced range and / or simplified user interface configured to allow a user to interact with and / or otherwise control one or more elements of the wearable device 1132, e.g., without using the programmer 1136. For example, the wearable device user interface can allow a user to check a charge status of a power source, power on and / or off the wearable device 1132, adjust one or more of the signal delivery parameters, configure and / or verify therapy delivery, select one or more therapy presets, confirm and / or verify placement of the wearable device, etc.

[0137] The charger 1134 for the wearable device 1132 can be configured to power the power source of the wearable device 1132. The charger 1134 can include a wireless (e.g., inductive) charger, a wired charger (e.g., a wall plug, a charging cable, etc.), and / or any other suitable charger or charging device. Optionally, the charger 1134 can include an integrated controller and / or connected device, e.g., to control charging of the wearable device 1132 and / or upload / download data to / from the wearable device 1132 while the wearable device 1132 is charging.

[0138] The one or more signal delivery devices 1100 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 1100a-n), a power receiving device (e.g., one or more RF power antennas, one or more induction coils, etc.), a power rectifier / DC-DC converter, a circuit (e.g., one or more application specific integrated circuits (ASICs), state machines, etc.), a signal generator, and two or more electrodes that can each be 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 induction 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 1100 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) 1100. The circuit can include machine-readable instructions associated with the operation of the signal delivery device(s) 1100. For example, the circuit can include instructions that, when executed, can cause the signal generator to generate the modulation signal with the signal delivery parameter(s) received via the electrode receiver antenna. In these and other embodiments, the power receiving device and / or one or more other communication components can be used to transmit information associated with the signal delivery device 1100 to the wearable device 1132. For example, the signal delivery device 1100 can transmit, to the wearable device 1132, information associated with one or more signal delivery parameters of the modulation signal applied to the patient. In these and other embodiments, one or more of the signal delivery devices 1100 can include a hermetically sealed package or housing configured such that the signal delivery device(s) 1100 can be implanted within a patient.

[0139] In some embodiments, one or more of the signal delivery devices 1100 are passive devices that do not include an on-board pulse generator configured to generate a modulation signal. Rather, the passive signal delivery devices can receive a power signal wirelessly from the wearable device 1132 and transmit the received power signal to the wearer via an electrode. The passive signal delivery devices can adjust or otherwise process the received power signal, but do not use the received power signal to power an on-board pulse generator.

[0140] FIG. 12 FIG. 12 is a partial schematic side view showing another signal delivery device 1200 configured in accordance with embodiments of the present technology. FIG. 12The dimensions shown are for illustrative purposes only, and in at least some embodiments, all or one or more parts of the signal delivery device 1200 may have, in addition to FIG. 12 Dimensions other than those shown. In at least some embodiments, the signal delivery device 1200 may be structurally and / or functionally similar to... FIG. 1D The signal delivery device 100 is at least substantially similar to or identical to the signal delivery device 1200 shown. For example, the signal delivery device 1200 shown includes a housing 1202, an electrode array 1204 coupled to the housing 1202, a signal generator 1206, and an antenna 1208. The electrode array 1204 may include a monopole electrode array or a bipole (or other multipole) electrode array. In some embodiments, the electrode array 1204 may include electrodes formed of Pt and / or Ir (such as Pt90 / Ir10) and / or one or more other suitable materials. The housing 1202 may be configured to hermetically house one or more circuit components of the signal delivery device 1200, including the signal generator 1206 and / or the antenna 1208. All or part of the housing 1202 may be formed of Pt, PtIr, Ti6AL4V, epoxy resin, TPE, one or more ceramics, and / or one or more other suitable materials. For example, the portion of housing 1202 surrounding antenna 1208 may be formed of epoxy resin, ceramic, TPE, and / or one or more other materials configured to prevent or at least partially prevent interference with power transmission to antenna 1208. Optionally, at least a portion of housing 1202 may be electrically activated and configured to function as electrodes, for example, when electrode array 1204 is monopole.

[0141] Additionally, the signal delivery device 1200 includes a lead portion 1203 coupled to a housing 1202 and carrying an electrode array 1204. The lead portion 1203 may be at least substantially flexible and / or otherwise configured to undergo elastic deformation. In some embodiments, the lead portion 1203 may be separable from the housing 1202 and configured, for example, to be coupled to and / or mated with the housing 1202 in-body. In some embodiments, the lead portion 1203 may be formed of one or more thermoplastic polyurethanes (TPUs), such as Tecothane™ and / or one or more other suitable materials. The lead portion 1203 may include one or more wires and / or other conductive elements electrically connecting the electrode array 1204 to a signal generator 1206. The wires / conductive elements may be formed of MP35N and / or one or more other suitable conductive materials.

[0142] Therefore, in some aspects of this technology, one or more signal delivery devices can be implanted in a patient to deliver one or more modulating signals to the patient's cervical loop nerve and / or one or more muscles innervated by the cervical loop nerve. Delivery of modulating signals to the cervical loop nerve can induce caudal traction, or at least stiffen one or more tissues defining the patient's airway, to improve airflow and / or otherwise resolve airway obstruction. Cervical loop modulation itself is expected to resolve airway obstruction in many patients. Compared to other target tissues (e.g., the hypoglossal nerve, one or more of the infrahyoid band muscle, etc.), modulating the cervical loop to improve airflow can be achieved at a lower amplitude and is therefore expected to resolve airway obstruction with a lower patient arousal rate and / or reduced power delivery requirements. Patients for whom cervical loop modulation is insufficient to adequately improve airflow can receive another signal delivery device, for example, implanted to deliver modulating signals to the patient's hypoglossal nerve, allowing for modulation of the hypoglossal nerve as needed to improve airflow. Similarly, patients whose hypoglossal nerve modulation is insufficient to adequately improve airflow can receive another signal delivery device, for example, implanted to deliver modulation signals to the patient's cervical loop, so that the cervical loop nerves in these patients can be modulated as needed to improve the patient's airflow.

[0143] 6. Examples

[0144] The following examples provide further embodiments of this technology:

[0145] 1. A method for resolving sleep apnea in a patient, the method comprising:

[0146] The implantable signal delivery device is percutaneously inserted at the insertion point in the patient's neck;

[0147] The signal delivery device is moved toward the patient's loop cervical nerve in a direction from medial to lateral; and

[0148] The signal delivery device is implanted at a target location at least near the cervical loop nerve, wherein the signal delivery device includes at least one electrode positioned to deliver modulating signals to tissue at least near the target location.

[0149] 2. The method according to Example 1, wherein moving the signal delivery device in a direction from inside to outside includes moving the signal delivery device away from the midsagittal plane relative to the patient's midsagittal plane at an angle between about 20 degrees and about 80 degrees.

[0150] 3. The method according to Example 2, wherein the angle is between approximately 45 degrees and approximately 80 degrees.

[0151] 4. The method of example 3, wherein the angle is about 60 degrees and about 80 degrees.

[0152] 5. The method of examples 1-4, wherein implanting the signal delivery device comprises implanting the signal delivery device proximate at least an upper branch of the cervical loop nerve of the patient.

[0153] 6. The method of examples 1-4, wherein implanting the signal delivery device comprises implanting the signal delivery device proximate at least a lower branch of the cervical loop nerve of the patient.

[0154] 7. The method of examples 1-4, wherein implanting the signal delivery device comprises implanting the signal delivery device proximate at least a branch of the cervical loop nerve that innervates the sternohyoid muscle of the patient.

[0155] 8. The method of examples 1-4, wherein implanting the signal delivery device comprises implanting the signal delivery device proximate at least a branch of the cervical loop nerve that innervates the sternothyroid muscle of the patient.

[0156] 9. The method of examples 1-4, wherein implanting the signal delivery device comprises implanting the signal delivery device proximate at least a branch of the cervical loop nerve that innervates the thyrohyoid muscle of the patient.

[0157] 10. The method of examples 1-4, wherein implanting the signal delivery device comprises implanting the signal delivery device proximate at least a branch of the cervical loop nerve that innervates both the sternohyoid muscle of the patient and the thyrohyoid muscle of the patient.

[0158] 11. The method of examples 1-4, wherein implanting the signal delivery device comprises implanting the signal delivery device proximate at least a distal end of a branch of the cervical loop nerve to deliver the modulation signal to an origin of the branch that innervates one of the sternohyoid muscle of the patient, the thyrohyoid muscle of the patient, or the sternothyroid muscle of the patient.

[0159] 12. The method of examples 1-4, wherein implanting the signal delivery device proximate at least a target location comprises implanting the signal delivery device proximate at least the strap muscles of the patient.

[0160] 13. The method of example 12, wherein implanting the signal delivery device proximate at least the strap muscles comprises implanting the signal delivery device proximate at least the sternothyroid muscle, the sternohyoid muscle, the sternothyreoid muscle, and / or the thyrohyoid muscle of the patient.

[0161] 14. The method of examples 1-13, further comprising delivering the signal to the target tissue to increase stability of at least a portion of the patient's airway, including one or more of: (i) increasing stiffness of at least a portion of a pharyngeal wall of the patient's airway, (ii) increasing a size of a posterior pharyngeal airway of the patient, and (iii) decreasing resistance to airflow through at least the portion of the airway.

[0162] 15. The method of examples 1-14, further comprising delivering the signal to the target tissue to induce caudal traction by reducing one or both of a hyoid bone of the patient and / or a thyroid cartilage of the patient.

[0163] 16. The method of examples 1-15, wherein percutaneously inserting the signal delivery device includes moving the signal delivery device in a direction from anterior to posterior.

[0164] 17. The method of examples 1-16, wherein percutaneously inserting the signal delivery device includes moving the signal delivery device in a direction from inferior to superior.

[0165] 18. The method of examples 1-16, wherein percutaneously inserting the signal delivery device includes moving the signal delivery device in a direction from superior to inferior.

[0166] 19. The method of examples 1-18, wherein percutaneously inserting the signal delivery device into the neck includes percutaneously inserting the signal delivery device along an insertion path that is angled relative to the mid-sagittal plane.

[0167] 20. The method of example 19, wherein the insertion path includes a first path portion that is angled relative to the mid-sagittal plane at a first angle and a second path portion that is angled relative to the mid-sagittal plane at a second angle, the second angle being different than the first angle.

[0168] 21. The method of example 20, wherein the first path portion is proximal to the insertion point, and wherein percutaneously inserting the signal delivery device along the second path portion includes percutaneously inserting the signal delivery device along the second path portion at a second angle that is greater than the first angle.

[0169] 22. The method of examples 1-21, further comprising delivering the modulating signal via the signal delivery device, wherein delivering the modulating signal includes inducing caudal traction to at least partially address sleep apnea of the patient.

[0170] 23. The method of examples 1-22, further comprising delivering the modulating signal via the signal delivery device, wherein delivering the modulating signal comprises at least partially preventing collapse of the patient’s airway.

[0171] 24. The method of examples 1-23, further comprising delivering the modulating signal via the signal delivery device, wherein delivering the modulating signal comprises at least partially preventing collapse of at least a portion of the patient’s post-palatine tissue.

[0172] 25. The method of example 24, wherein at least partially preventing collapse of at least the portion of the patient’s post-palatine tissue comprises preventing collapse of at least a portion of the patient’s palatopharyngeal and / or oropharyngeal tissue.

[0173] 26. The method of examples 1-25, further comprising delivering the modulating signal via the signal delivery device, wherein delivering the modulating signal comprises reducing a number, frequency, and / or severity of one or more apnea events experienced by the patient over a predetermined time period.

[0174] 27. The method of examples 1-26, further comprising delivering the modulating signal via the signal delivery device, wherein delivering the modulating signal comprises reducing a number, frequency, and / or severity of one or more hypopnea events experienced by the patient over a predetermined time period.

[0175] 28. The method of example 26 or example 27, wherein the predetermined time period comprises during delivery of the modulating signal.

[0176] 29. The method of examples 26-28, wherein the predetermined time period comprises a time period after delivery of the modulating signal.

[0177] 30. The method of any of examples 1-29, further comprising:

[0178] generating physiological data via one or more sensors of the signal delivery device; and

[0179] delivering the modulating signal to the target tissue based at least in part on the generated physiological data.

[0180] 31. The method of example 30, wherein delivering the modulating signal comprises adjusting one or more parameters of the modulating signal based at least in part on the generated physiological data.

[0181] 32. The method of any of examples 1-31, further comprising wirelessly receiving power via an antenna of the signal delivery device.

[0182] 33. The method of example 32, wherein wirelessly receiving power comprises receiving RF power.

[0183] 34. The method of example 32, wherein wirelessly receiving power comprises inductively receiving power.

[0184] 35. The method of any of examples 32-34, further comprising storing at least a portion of the received power in a charge storage device.

[0185] 36. The method of example 35, wherein the charge storage device has a total charge storage capacity of no more than 1 second, 5 seconds, 10 seconds, 15 seconds, 20 seconds, 25 seconds, 30 seconds, 1 minute, 2 minutes, or 5 minutes.

[0186] 37. A method for addressing sleep apnea in a patient, the method comprising:

[0187] programming a first signal delivery device to deliver a first modulation signal to a first target tissue of the patient from a location proximate at least a hypoglossal nerve of the patient; and

[0188] programming a second signal delivery device to deliver a second modulation signal to a second target tissue of the patient, the second target tissue being different from the first target tissue and proximate at least one or more anterior branches of an inferior ganglion of the patient.

[0189] 38. The method of example 37, wherein,

[0190] programming the first signal delivery device comprises programming the first signal delivery device to deliver the first modulation signal having first signal delivery parameters, and

[0191] programming the second signal delivery device comprises programming the second signal delivery device to deliver the second modulation signal having second signal delivery parameters different from the first signal delivery parameters.

[0192] 39. The method of example 37 or 38, wherein,

[0193] programming the first signal delivery device comprises programming the first signal delivery device to deliver the first modulation signal having a first amplitude, and

[0194] programming the second signal delivery device comprises programming the second signal delivery device to deliver the second modulation signal having a second amplitude different from the first amplitude.

[0195] 40. The method of examples 37-39, wherein,

[0196] programming the first signal delivery device includes programming the first signal delivery device to deliver the first conditioning signal having a first frequency, and

[0197] programming the second signal delivery device includes programming the second signal delivery device to deliver the second conditioning signal having a second frequency different from the first frequency.

[0198] 41. The method of examples 37-40, wherein,

[0199] programming the first signal delivery device includes programming the first signal delivery device to deliver the first conditioning signal having a first pulse width, and

[0200] programming the second signal delivery device includes programming the second signal delivery device to deliver the second conditioning signal having a second pulse width different from the first pulse width.

[0201] 42. The method of examples 37-41, wherein,

[0202] programming the first signal delivery device includes programming the first signal delivery device to vary an amplitude of the first electrical signal during delivery, and

[0203] programming the second signal delivery device includes programming the second signal delivery device to vary an amplitude of the second electrical signal during delivery.

[0204] 43. The method of example 42, wherein varying the amplitude of one or both of the first conditioning signal and the second conditioning signal includes ramping the amplitude from a first value to a second value greater than the first value.

[0205] 44. The method of examples 37-43, wherein,

[0206] programming the first signal delivery device includes programming the first signal delivery device to deliver the first conditioning signal during a time period, and

[0207] programming the second signal delivery device includes programming the second signal delivery device to deliver the second conditioning signal during the time period.

[0208] 45. The method of examples 37-44, wherein,

[0209] programming the first signal delivery device includes programming the first signal delivery device to deliver the first modulation signal during a first time period, and

[0210] programming the second signal delivery device includes programming the second signal delivery device to deliver the second modulation signal during a second time period that is at least partially different from the first time period.

[0211] 46. The method of example 45, wherein the second time period is after the first time period.

[0212] 47. The method of example 45, wherein the second time period is contemporaneous with a portion of the first time period.

[0213] 48. The method of any of examples 37-47, wherein,

[0214] programming the first signal delivery device to deliver the first modulation signal includes programming the first signal delivery device to deliver the first modulation signal based at least in part on data received via a sensor; and / or

[0215] programming the second signal delivery device to deliver the second modulation signal includes programming the second signal delivery device to deliver the second modulation signal based at least in part on data received via the sensor.

[0216] 49. The method of example 48, wherein,

[0217] programming the first signal delivery device to deliver the first modulation signal based at least in part on data received via the sensor includes programming the first signal delivery device to change at least one first signal delivery parameter of the first modulation signal based at least in part on the data or a change in the data; and / or

[0218] programming the second signal delivery device to deliver the second modulation signal based at least in part on data received via the sensor includes programming the second signal delivery device to change at least one second signal delivery parameter of the second modulation signal based at least in part on the data or a change in the data.

[0219] 50. A method for addressing sleep apnea in a patient, the method comprising:

[0220] activating a first signal delivery device to deliver a first modulation signal to a first target tissue of the patient from a location at least proximate to a glossopharyngeal nerve of the patient; and

[0221] activating a second signal delivery device to deliver a second modulating signal to a second target tissue of the patient, the second target tissue being different from the first target tissue and at least proximate to one or more anterior branches of the hypoglossal nerve of the patient.

[0222] 51. A method for addressing sleep apnea in a patient, the method comprising:

[0223] transcutaneously inserting an implantable signal delivery device at an insertion point on the neck of the patient;

[0224] moving the signal delivery device in a medial-to-lateral direction toward a branch of the cervical vagus nerve of the patient that innervates the sternohyoid muscle of the patient and the sternothyroid muscle of the patient; and

[0225] implanting the signal delivery device at a target location at least proximate to a motor point of the branch at which the branch innervates the sternohyoid muscle or the sternothyroid muscle, wherein the signal delivery device includes at least one electrode positioned to deliver a modulating signal to tissue at least proximate to the target location, and

[0226] delivering a modulating signal to at least a portion of the branch to induce a motor response in one or both of the sternohyoid muscle and the sternothyroid muscle to address sleep apnea in the patient.

[0227] 52. The method of example 51, wherein the branch includes a first sub-branch that innervates the sternohyoid muscle and a second sub-branch that innervates the sternothyroid muscle, and wherein implanting the signal delivery device at the target location includes implanting the signal delivery device at least partially between the first sub-branch and the second sub-branch.

[0228] 53. The method of example 51, wherein the branch includes a first sub-branch that innervates the sternohyoid muscle and a second sub-branch that innervates the sternothyroid muscle, and wherein implanting the signal delivery device at the target location includes implanting the signal delivery device across the first sub-branch and the second sub-branch.

[0229] 54. The method of example 51, wherein the branch includes a first sub-branch that innervates the sternohyoid muscle and a second sub-branch that innervates the sternothyroid muscle, and wherein implanting the signal delivery device at the target location includes implanting the signal delivery device transverse to the first sub-branch and the second sub-branch.

[0230] 54. The method according to Example 51, wherein the movement point of the branch includes a plurality of anterior branches, and wherein implanting the signal delivery device at the target location includes implanting the signal delivery device to deliver the modulation signal to an individual anterior branch among the plurality of anterior branches.

[0231] 55. The method according to Example 54, wherein implanting the signal delivery device to deliver the modulation signal to an individual anterior branch among the plurality of anterior branches includes implanting the signal delivery device, wherein the electrode array of the signal delivery device is at least substantially transverse to at least a subset of the plurality of anterior branches.

[0232] 56. A system for resolving a patient's airway obstruction, the system comprising:

[0233] An implantable signal delivery device configured to deliver modulating signals to the patient's cervical loop nerve, and

[0234] The controller, communicatively coupled to the implantable signal delivery device, is configured to:

[0235] Receive input corresponding to the adjustment threshold of the patient.

[0236] The adjustment parameters are determined at least in part based on the input, and

[0237] The signal delivery device is instructed to generate the modulation signal at least in part based on the modulation parameters.

[0238] 57. The system according to Example 56, wherein the adjustment threshold includes a wake-up threshold, at which the adjustment signal wakes the patient from sleep.

[0239] 58. The system according to Example 56 or Example 57, wherein the modulation threshold includes a perception threshold at which the patient consciously perceives the delivery of the modulation signal.

[0240] 59. The system according to any one of Examples 56-58, wherein the adjustment parameter includes the amplitude of the adjustment signal.

[0241] 60. The system according to any one of Examples 56-59, wherein the controller is configured to determine the adjustment parameter by reducing the adjustment signal by a predetermined amount.

[0242] 61. The system according to any of Examples 56 to 60, wherein the adjustment threshold is associated with a first value of the adjustment parameter, and wherein the controller is configured to determine a second value of the adjustment parameter that is different from the first value.

[0243] 62. The system of any of examples 56-61, wherein the modulation threshold is associated with a first value of the modulation parameter, and wherein the controller is configured to determine a second value of the modulation parameter that is less than the first value.

[0244] 63. The system of any of examples 56-62, wherein the implantable signal delivery device is a first implantable signal delivery device, wherein the modulation signal is a first modulation signal, and wherein the system further comprises a second implantable signal delivery device configured to be positioned to deliver a second modulation signal to the hypoglossal nerve of the patient.

[0245] 64. A method of addressing respiratory obstruction in a patient, the method comprising:

[0246] delivering a first modulation signal to a cervical slingshot nerve of the patient;

[0247] determining a first value of a modulation parameter associated with a modulation threshold of the cervical slingshot nerve of the patient; and

[0248] delivering a second modulation signal to the cervical slingshot nerve of the patient at a second value of the modulation parameter that is different from the modulation threshold.

[0249] 65. The method of example 64, wherein the modulation threshold comprises a wake threshold at which the modulation signal causes the patient to wake from sleep.

[0250] 66. The method of example 64 or example 65, wherein the modulation threshold comprises a perception threshold at which the patient consciously perceives delivery of the modulation signal.

[0251] 67. The method of any of examples 64-66, wherein the modulation parameter comprises an amplitude of the modulation signal.

[0252] 68. The method of any of examples 64-67, wherein delivering the second modulation signal comprises decreasing the first value of the modulation parameter by a predetermined amount to determine the second value of the modulation parameter.

[0253] 69. The method of any of examples 64-68, wherein the second value of the modulation parameter is less than the first value.

[0254] 70. A system for addressing respiratory obstruction in a patient, the system comprising:

[0255] an implantable signal delivery device configured to be positioned to deliver a modulation signal to a cervical slingshot nerve of the patient, and

[0256] a controller communicatively coupled to the implantable signal delivery device and configured to:

[0257] receive an input corresponding to a modulation threshold of a glossopharyngeal nerve of the patient,

[0258] determine, based at least in part on the input, a modulation parameter value different from the modulation threshold, and

[0259] instruct the implantable signal delivery device to generate the modulation signal based at least in part on the modulation parameter value.

[0260] 71. The system of claim 70, wherein the modulation parameter value is less than the modulation threshold by a predetermined amount.

[0261] 72. The system of claim 70, wherein the modulation threshold is a first value of a modulation parameter, and wherein the modulation parameter value is a second value of the modulation parameter less than the first value.

[0262] 73. The system of claim 72, wherein the modulation parameter comprises a modulation amplitude.

[0263] 74. The system of claim 70, wherein the modulation threshold comprises a wake-up threshold at which the modulation signal causes the patient to wake from sleep.

[0264] 75. The system of claim 70, wherein the modulation threshold comprises a perception threshold at which the patient consciously perceives delivery of the modulation signal.

[0265] 76. The system of claim 70, wherein the modulation parameter comprises a modulation pulse width.

[0266] 77. The system of claim 70, wherein the modulation parameter comprises a modulation pulse width, wherein the modulation threshold comprises a first pulse width value, and wherein the modulation parameter value comprises a second pulse width value greater than the first pulse width value.

[0267] 78. A method of addressing respiratory obstruction in a patient, the method comprising:

[0268] causing a first modulation signal to be delivered to a glossopharyngeal nerve of the patient to produce a first response in a muscle of the patient innervated by the glossopharyngeal nerve;

[0269] obtaining a first value of a modulation parameter associated with a modulation threshold of the glossopharyngeal nerve of the patient; and

[0270] causing a second modulation signal to be delivered to the patient's glossopharyngeal nerve at a second value of the modulation parameter different from the modulation threshold to produce a second response in the muscle different from the first response.

[0271] 79. The method of example 78, wherein the first response comprises a full muscle response, and wherein the second response is less than the full muscle response.

[0272] 80. The method of example 78 or 79, wherein the muscle comprises the patient's sternothyroid muscle and / or the patient's sternohyoid muscle.

[0273] 81. The method of any one of examples 78-80, wherein obtaining the first value of the modulation parameter associated with the modulation threshold comprises obtaining a first value of the modulation parameter associated with a wake-up threshold at which modulation of the glossopharyngeal nerve causes the patient to wake up from sleep.

[0274] 82. The method of any one of examples 78-81, wherein obtaining the first value of the modulation parameter associated with the modulation threshold comprises obtaining a first value of the modulation parameter associated with a perception threshold at which the patient consciously perceives modulation of the glossopharyngeal nerve.

[0275] 83. The method of any one of examples 78-82, wherein

[0276] obtaining the first value of the modulation parameter comprises obtaining a first modulation amplitude associated with the modulation threshold of the glossopharyngeal nerve of the patient, and

[0277] causing the second modulation signal to be delivered comprises causing the second modulation signal to be delivered at a second modulation amplitude less than the first modulation amplitude.

[0278] 84. The method of any one of examples 78-83, wherein delivering the second modulation signal comprises decreasing the first value of the modulation parameter by a predetermined amount.

[0279] 85. The method of any one of examples 78-84, wherein the second value of the modulation parameter is less than the first value and the modulation threshold.

[0280] 86. A method for addressing sleep apnea in a patient, the method comprising:

[0281] transcutaneously inserting an implantable signal delivery device at an insertion point on the patient's neck;

[0282] moving the signal delivery device in a direction from lateral to medial toward the patient's cervical loop nerve; and

[0283] implanting the signal delivery device at a target location proximate at least the cervical loop nerve, wherein the signal delivery device comprises at least one electrode positioned to deliver a modulation signal to tissue proximate at least the target location.

[0284] 87. The method of example 86, wherein moving the signal delivery device comprises moving the signal delivery device toward a midsagittal plane of the patient at an angle between about 20 degrees and about 80 degrees relative to the midsagittal plane.

[0285] 88. The method of example 86 or 87, wherein moving the signal delivery device comprises moving the signal delivery device toward a midsagittal plane of the patient at an angle between about 45 degrees and about 80 degrees relative to the midsagittal plane.

[0286] 89. The method of any of examples 86-88, further comprising rotating the patient's head back to expose the insertion point prior to percutaneously inserting the implantable signal delivery device.

[0287] 90. The method of any of examples 86-89, wherein implanting the signal delivery device comprises implanting the signal delivery device proximate at least a lower branch of the cervical loop nerve of the patient.

[0288] 91. The method of any of examples 86-90, wherein implanting the signal delivery device comprises implanting the signal delivery device proximate at least a branch of the cervical loop nerve that innervates the sternohyoid muscle, sternothyroid muscle, or omohyoid muscle of the patient.

[0289] 92. The method of any of examples 86-91, wherein implanting the signal delivery device comprises implanting the signal delivery device proximate at least a branch of the cervical loop nerve that innervates both the sternohyoid muscle of the patient and the sternothyroid muscle of the patient.

[0290] 93. The method of any of examples 86-92, wherein implanting the signal delivery device comprises implanting the signal delivery device proximate at least a distal end of a branch of the cervical loop nerve to deliver the modulation signal to an origin of the branch that innervates one of the sternohyoid muscle of the patient, the sternothyroid muscle of the patient, or the omohyoid muscle of the patient.

[0291] 94. The method of any of examples 86-93, wherein implanting the signal delivery device at least proximate the target location comprises implanting the signal delivery device at least proximate a sternothyroid muscle, a sternohyoid muscle, a levator veli palatini muscle, and / or a thyrohyoid muscle of the patient.

[0292] 95. The method of any of examples 86-94, further comprising delivering the modulating signal to the target tissue to increase a stability of at least a portion of an airway of the patient comprising one or more of: (i) increasing a stiffness of at least a portion of a pharyngeal wall of the airway of the patient, (ii) increasing a size of a posterior pharyngeal airway of the patient, and (iii) decreasing a resistance of airflow through at least the portion of the airway.

[0293] 96. The method of any of examples 86-95, further comprising delivering the modulating signal to the target tissue to induce a laryngeal pull back by reducing one or both of a hyoid bone of the patient and / or a thyroid cartilage of the patient.

[0294] 97. The method of any of examples 86-96, wherein percutaneously inserting the signal delivery device comprises moving the signal delivery device in a direction from anterior to posterior.

[0295] 98. The method of any of examples 86-97, wherein percutaneously inserting the signal delivery device comprises moving the signal delivery device in a direction from inferior to superior.

[0296] 99. The method of any of examples 86-97, wherein percutaneously inserting the signal delivery device comprises moving the signal delivery device in a direction from superior to inferior.

[0297] In accordance with the foregoing, it is believed that positioning a signal delivery device to deliver a modulating signal to the AC of the ansa cervicalis nerve will reduce or prevent airway collapse in the post-palatal (e.g., the palatopharyngeal and oropharyngeal) regions of a patient’s airway without or generally without affecting the ability of tongue base collapse reduction and / or interfering with other modulation (e.g., hypoglossal nerve modulation) to reduce or prevent tongue base collapse. Additionally, the combination of ansa cervicalis AC modulation and hypoglossal nerve modulation is expected to provide a therapeutic solution for a wider range of collapse sites in the upper airway, resulting in (1) more effective treatment for patients whose collapse patterns (e.g., palatopharyngeal collapse patterns) are not fully targeted by hypoglossal nerve modulation alone, and (2) a broadened potential population in which neuromodulation can be an effective treatment by targeting additional collapse sites. For example, and as previously described herein, multi-site signal delivery is expected to increase the potential patient responder population to include, for example, patients that would not respond to hypoglossal nerve modulation alone (e.g., patients with primary palatopharyngeal collapse, no soft palate coupling, BMI > 32, and / or airway complete concentric collapse). In these and other embodiments, the positions / orientations described herein are expected to reduce or minimize changes in the position / orientation of the signal delivery device during insertion and / or after implantation, and / or increase the speed and / or accuracy with which the signal delivery device can be positioned at least proximate to the target location.

[0298] It should be appreciated that specific embodiments of the disclosed technology have been described herein for purposes of illustration, but various modifications can 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 can be combined or eliminated in other embodiments. For example, two signal delivery devices can be implanted to bilaterally target tissue of a patient (e.g., the left and right ansa cervicalis nerves) and / or to target different tissue on the left and right sides of a patient (e.g., the patient’s left ansa cervicalis nerve and right thyroarytenoid muscle). Moreover, while advantages associated with certain embodiments of the disclosed technology have been described in the context of those embodiments, other embodiments can also exhibit such advantages, and not all embodiments 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.

[0299] As used herein, the phrase “and / or,” as in A and / or B, means A alone, B alone, and both A and B. Unless otherwise indicated, the terms “generally,” “about,” and “approximately” refer to values within 10% of the stated value. For example, use of the term “about 100” refers to a range of 90 to 110, inclusive of the end values. Where relative terms are used in reference to something that does not include a numerical value, those terms are given their ordinary meaning to one of skill in the art.

[0300] In the event that any of the material incorporated by reference therein conflicts with that of the present disclosure, the present disclosure controls.

Claims

1. A system for addressing respiratory obstruction in a patient, the system comprising: an implantable signal delivery device configured to be positioned to deliver a modulation signal to a cervical vagus nerve of the patient, and a controller communicatively coupled to the implantable signal delivery device and configured to: receive an input corresponding to a modulation threshold of the cervical vagus nerve of the patient, determine, based at least in part on the input, a modulation parameter value different from the modulation threshold, and instruct the implantable signal delivery device to generate the modulation signal based at least in part on the modulation parameter value.

2. The system of claim 1, wherein, the modulation parameter value is less than the modulation threshold by a predetermined amount.

3. The system of claim 1, wherein, the modulation threshold is a first value of a modulation parameter, and wherein the modulation parameter value is a second value of the modulation parameter less than the first value.

4. The system of claim 3, wherein, the modulation parameter comprises a modulation amplitude.

5. The system of claim 1, wherein, the modulation threshold comprises a wake threshold at which the modulation signal causes the patient to wake from sleep.

6. The system of claim 1, wherein, the modulation threshold comprises a perception threshold at which the patient consciously perceives delivery of the modulation signal.

7. The system of claim 1, wherein, the modulation parameter comprises a modulation pulse width.

8. The system of claim 1, wherein, the modulation parameter comprises a modulation pulse width, wherein the modulation threshold comprises a first pulse width value, and wherein the modulation parameter value comprises a second pulse width value greater than the first pulse width value.

9. A method of addressing respiratory obstruction in a patient, the method comprising: causing a first modulation signal to be delivered to a cervical vagus nerve of the patient to produce a first response in a muscle of the patient innervated by the cervical vagus nerve; obtaining a first value of a modulation parameter associated with a modulation threshold of the cervical vagus nerve of the patient; and causing a second modulation signal to be delivered to the cervical vagus nerve of the patient at a second value of the modulation parameter different from the modulation threshold to produce a second response in the muscle different from the first response. the first response comprises a full muscle response, and wherein the second response is less than the full muscle response.

10. The method of claim 9, wherein, the muscle comprises a sternothyroid muscle of the patient and / or a sternohyoid muscle of the patient.

11. The method of claim 9, wherein, obtaining the first value of the modulation parameter associated with the modulation threshold comprises obtaining a first value of the modulation parameter associated with a wake threshold at which modulation of the cervical vagus nerve causes the patient to wake from sleep.

12. The method of claim 9, wherein, obtaining the first value of the modulation parameter associated with the modulation threshold comprises obtaining a first value of the modulation parameter associated with a perception threshold at which the patient consciously perceives modulation of the cervical vagus nerve.

13. The method of claim 9, wherein, 14. The method of claim 9, wherein, obtaining the first value of the modulation parameter comprises obtaining a first modulation amplitude associated with the modulation threshold of the cervical vagus nerve of the patient, and causing the second modulation signal to be delivered comprises causing the second modulation signal to be delivered at a second modulation amplitude less than the first modulation amplitude. delivering the second modulation signal comprises decreasing the first value of the modulation parameter by a predetermined amount.

15. The method of claim 9, wherein, the second value of the modulation parameter is less than the first value and the modulation threshold.

16. The method of claim 9, wherein, ​ 17. A method for resolving sleep apnea in a patient, the method comprising: The implantable signal delivery device is percutaneously inserted at the insertion point in the patient's neck; The signal delivery device is moved toward the patient's cervical loop nerve in a direction from the outside to the inside. and The signal delivery device is implanted at a target location at least near the cervical loop nerve, wherein the signal delivery device includes at least one electrode positioned to deliver modulating signals to tissue at least near the target location.

18. The method of claim 17, wherein, Moving the signal delivery device includes moving the signal delivery device toward the midsagittal plane at an angle between about 20 degrees and about 80 degrees relative to the patient's midsagittal plane.

19. The method of claim 17, wherein, Moving the signal delivery device includes moving the signal delivery device toward the midsagittal plane at an angle between about 45 degrees and about 80 degrees relative to the patient's midsagittal plane.

20. The method of claim 17, further comprising: Before percutaneous insertion of the implantable signal delivery device, the patient's head is rotated backward to expose the insertion point.

21. The method of claim 17, wherein, Implanting the signal delivery device includes implanting the signal delivery device at least near the lower branch of the loop nerve of the neck of the patient.

22. The method of claim 17, wherein, The implantation of the signal delivery device includes implanting a branch of the cervical loop nerve that innervates the sternohyoid, sternothyroid, or omohyoid muscles of the patient.

23. The method of claim 17, wherein, The implantation of the signal delivery device includes implanting a branch of the cervical loop nerve at least close to both the sternohyoid muscle and the sternothyroid muscle of the patient.

24. The method of claim 17, wherein, Implanting the signal delivery device includes implanting the signal delivery device distally, at least near a branch of the loop cervical nerve, to deliver the modulating signal to a motor point of a branch innervating one of the patient's sternohyoid muscle, sternothyroid muscle, or omohyoid muscle.

25. The method of claim 17, wherein, Implanting the signal delivery device at least near the target location includes implanting the signal delivery device at least near the patient's sternothyroid, sternohyoid, omohyoid, and / or thyrohyoid muscles.

26. The method of claim 17, further comprising delivering the modulation signal to the target tissue to increase the stability of at least a portion of the patient's airway, comprising one or more of the following: (i) increasing the stiffness of at least a portion of the pharyngeal wall of the patient's airway, (ii) increasing the size of the patient's postpalatal airway, and (iii) reducing the resistance to airflow through at least said portion of the airway.

27. The method of claim 17, further comprising delivering the modulation signal to the target tissue to induce tail traction by depressing one or both of the patient's hyoid bone and / or thyroid cartilage.

28. The method of claim 17, wherein, Percutaneous insertion of the signal delivery device includes moving the signal delivery device in a direction from front to rear.

29. The method of claim 17, wherein, Percutaneous insertion of the signal delivery device includes moving the signal delivery device in a direction from bottom to top.

30. The method of claim 17, wherein, Percutaneous insertion of the signal delivery device includes moving the signal delivery device in a direction from top to bottom.

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