A method for positioning a signaling device to treat sleep apnea, and related devices and treatments.

Abstract

This technology generally relates to methods for addressing sleep apnea in patients. At least some of such methods include the steps of: percutaneously inserting an implantable signaling device at an insertion site on the patient's neck; moving the signaling device in an inward-outward direction toward the cervical loop; and implanting the signaling device at a target site at least near the cervical loop. The signaling device preferably has at least one electrode positioned to deliver a modulated signal to tissue at least near the target site, for example, in a portion of the cervical loop. In some embodiments, the delivery of the modulated signal can generate a caudal traction force within the patient's body, thereby addressing the patient's sleep apnea.

Description

[Technical Field]

[0001] The present invention relates to a method for positioning a signaling device to treat sleep apnea, as well as related methods and treatments.

[0002] [Reference to related applications] This application is a priority claim application to U.S. Provisional Patent Application No. 63 / 452,918, filed on 17 March 2023, and to U.S. Provisional Patent Application No. 63 / 622,867, filed on 19 January 2024. Both of these U.S. Provisional Patent Applications are incorporated herein by reference, and their entire contents are incorporated herein by reference. [Background technology]

[0003] Obstructive sleep apnea (OSA) is a condition in which a patient's upper airway is repeatedly obstructed (incomplete or complete) during sleep, causing awakening. Repeated upper airway obstructions can lead to sleep fragmentation, resulting in sleep deprivation, daytime fatigue, and / or malaise. In more severe cases of OSA, patients may be at increased risk of stroke, cardiac arrhythmias, hypertension, and / or other disorders.

[0004] OSA is characterized by a tendency for the soft tissues of the upper airway to collapse or sag during sleep, thereby obstructing the upper airway. OSA is typically caused by collapse of the soft palate, oropharynx, tongue, epiglottis, or a combination thereof into the patient's upper airway, which can disrupt normal breathing and / or cause awakening from sleep. [Overview of the project] [Problems that the invention aims to solve]

[0005] There are several treatment options for OSA, including, for example, surgery, continuous positive airway pressure (CPAP) devices, and electrical stimulation of the muscles associated with the upper airway that move the tongue (or other upper airway tissues). Surgical procedures include surgery to remove part of the patient's tongue and / or soft palate, and other procedures that attempt to prevent the tongue from falling back into the pharynx. These surgical procedures are extremely invasive. CPAP devices apply positive air pressure to the patient's nose and mouth to try to keep the upper airway open. However, these devices can be uncomfortable, difficult to use, and may have low compliance rates.

[0006] Some electrical modulation techniques attempt to prevent the tongue from falling back into the pharynx by causing it to protrude forward (e.g., forward) and / or flatten during sleep. However, existing techniques that electrically stimulate the nerves in the patient's oral cavity have the drawbacks of being too invasive and / or not sufficiently effective. Thus, there is a need for improved, minimally invasive treatments for OSA and other sleep disorders. [Means for solving the problem]

[0007] According to one aspect of the present invention, a method for addressing a patient's sleep apnea is provided. At least some of such methods include the steps of: percutaneously inserting an implantable signaling device at an insertion site on the patient's neck; moving the signaling device in an inward-outward direction toward the cervical loop; and implanting the signaling device at a target site at least near the cervical loop. The signaling device preferably has at least one electrode positioned to deliver a modulated signal to tissue at least near the target site, for example, in a portion of the cervical loop. In some embodiments, the delivery of the modulated signal can generate a caudal traction force within the patient's body, thereby addressing the patient's sleep apnea. [Brief explanation of the drawing]

[0008] [Figure 1A] This is a lateral cross-sectional view showing the patient's upper airway. [Figure 1B] This is a schematic diagram showing representative nerve structures and muscle tissue in the mandibular and cervical regions of a patient. [Figure 1C] This is a schematic diagram of the cervical nerve loop. [Figure 1D] This is a front cross-sectional view showing the patient's neck and mandible, as well as a portion of a signal transmission device positioned according to various embodiments of this technology. [Figure 2A] This is a frontal cross-sectional view of a portion of the patient's neck and mandible, and shows the insertion path of the signal transmission device according to various embodiments of this technology. [Figure 2B] This is a cross-sectional view showing the range of the signal transmission device insertion path according to various embodiments of this technology. [Figure 2C] This is a cross-sectional view showing the insertion path of a signal transmission device according to various embodiments of this technology. [Figure 2D] This is a cross-sectional view showing the insertion path of a signal transmission device according to various embodiments of this technology. [Figure 2E] This is a cross-sectional view showing the insertion path of a signal transmission device according to various embodiments of this technology. [Figure 3A] This is a frontal view of a portion of the patient's neck and mandible, each showing the angular range of the insertion path for the signal transmission device from the inside to the outside according to an embodiment of this technology. [Figure 3B] This is a lateral cross-sectional view of a portion of the patient's neck and mandible, where each shows the angular range of the insertion path of the signal transmission device from the inside to the outside (hereinafter sometimes referred to as "inside-outside") according to an embodiment of this technology. [Figure 3C] This is a frontal view of a portion of the patient's neck and mandible, each showing the angular range of the lateral-medial signal transmission device insertion path according to an embodiment of this technology. [Figure 3D] This is a lateral cross-sectional view of a portion of the patient's neck and mandible, each showing the angular range of the lateral-medial signal transmission device insertion path according to an embodiment of this technology. [Figure 4A]A front cross-sectional view of a patient's neck and a portion of the lower jaw, showing the implantation position and insertion path of a signal transmission device according to various embodiments of the present technology. [Figure 4B] A front cross-sectional view of a patient's neck and a portion of the lower jaw, showing the implantation position and insertion path of a signal transmission device according to various embodiments of the present technology. [Figure 4C] A side cross-sectional view showing a signal transmission device positioned according to various embodiments of the present technology. [Figure 5A] A side cross-sectional view of a patient's neck and a portion of the lower jaw, showing the implantation position of a signal transmission device according to various embodiments of the present technology. [Figure 5B] A side cross-sectional view of a patient's neck and a portion of the lower jaw, showing the implantation position of a signal transmission device according to various embodiments of the present technology. [Figure 6A] A side cross-sectional view of a patient's neck and a portion of the lower jaw, showing a signal transmission device positioned at least near a 1 / 3 portion of a branch of the patient's cervical nerve sheath according to various embodiments of the present technology. [Figure 6B] A side cross-sectional view of a patient's neck and a portion of the lower jaw, showing a signal transmission device positioned at least near a 1 / 3 portion of a branch of the patient's cervical nerve sheath according to various embodiments of the present technology. [Figure 6C] A side cross-sectional view of a patient's neck and a portion of the lower jaw, showing a signal transmission device positioned at least near a 1 / 3 portion of a branch of the patient's cervical nerve sheath according to various embodiments of the present technology. [Figure 6D] A side cross-sectional view of a patient's neck and a portion of the lower jaw, showing a signal transmission device positioned at least near a 1 / 3 portion of a branch of the patient's cervical nerve sheath according to various embodiments of the present technology. [Figure 7A] A front cross-sectional view of a patient's neck and a portion of the lower jaw, and a signal transmission device positioned according to various embodiments of the present technology. [Figure 7B] A side cross-sectional view of a patient's neck and a portion of the lower jaw, and the signal transmission device of FIG. 7A. [Figure 8]Front cross-sectional view of a patient's neck and a portion of the lower jaw, and a signal transmission device positioned according to embodiments of the present technology. [Figure 9A] Side cross-sectional view of a portion of the anatomical structure of a patient's neck and lower jaw. [Figure 9B] Side cross-sectional view of a portion of the anatomical structure of a patient's neck and lower jaw, showing a state in which first and second signal transmission devices are provided and positioned according to embodiments of the present technology. [Figure 10A] Plot diagram of patient data obtained by directing a modulated signal towards a patient's cervical nerve sheath according to embodiments of the present technology. [Figure 10B] Diagram showing a table containing data obtained by positioning and activating (starting up) a signal transmission device according to embodiments of the present technology. [Figure 10C] Plot diagram showing the degree of airflow recovery for a patient listed in the table of FIG. 10B. [Figure 11] Block diagram showing components of a system for treating sleep disorders according to embodiments of the present technology. [Figure 12] Partial schematic side view showing another signal transmission device configured according to embodiments of the present technology.

Best Mode for Carrying Out the Invention

[0009] For ease of reading, the present technology will be described under the following headings. Heading 1 : "Introduction Section" Heading 2 : "Overall Physiological Characteristics of the Patient" (focusing on FIGS. 1A to 1D) Heading 3 : "Typical Insertion Routes and Target Tissues" (focusing on FIGS. 2A to 9B) Heading 4 : "Typical Experimental Data" (focusing on FIGS. 10A to 10C) Heading 5 : "Additional Devices, Systems, and Methods" (focusing on FIGS. 11 and 12) Heading 6 : "Embodiment"

[0010] Embodiments of the present technology are described under the selected headings above, but other embodiments of the present technology may include components described under numerous headings. Therefore, even if an embodiment can be described under a particular heading, that embodiment is not limited to the components described under that heading.

[0011] 1. Introduction Electrical stimulation therapy for obstructive sleep apnea (OSA) typically involves delivering a modulated current that modulates nerves and / or muscles to (i) cause the tongue and / or other soft tissues to move and / or (ii) alter tissue tension (e.g., tighten or stiffen muscles without muscle contraction or stretching that would produce movement). Thus, electrical stimulation can relieve upper airway obstruction and prevent the tongue or other soft tissues from collapsing or obstructing the airway. As used herein, the terms “modulate” and “stimulate” are used interchangeably to mean having an effect on nerves, muscles and / or other tissues (having an effect on one or more motor functions, e.g., respiratory motor functions).

[0012] Representative methods and apparatus for reducing the incidence and / or severity of respiratory disorders, such as OSA, OSA with complete concentric collapse ("CCC"), and / or other conditions, are disclosed herein. In some embodiments, a signaling device is implanted near, or in contact with, one or more target tissues in the patient's upper airway, such as one or more nerves innervating the patient's airway and / or oral muscles. The signaling device can be implanted in the patient's body by minimally invasive subcutaneous injection. The signaling device can receive power wirelessly from an external device and use this power to generate and / or transmit precisely targeted modulation signals (e.g., electrical signals, stimulation pulses, etc.) to target tissues, thereby improving the patency of the patient's upper airway and / or improving the tension of the oral cavity tissues. The external device may have one or more mouthpiece portions, collar portions, chin strap portions, pillow portions, mattress overlay portions, and / or one or more other suitable wearable structures.

[0013] Typical target tissues include nerves, such as the cervical loop and / or hypoglossal nerve located adjacent to and / or around the oral cavity or within the neck. Stimulating the cervical loop can generate caudal traction (e.g., of the trachea), causing the hyoid bone to descend or be pushed down and / or stabilizing or strengthening the tongue and / or soft tissues of the upper airway. This can reduce or prevent tissue collapse and / or other airflow obstructions in the patient's airway, thereby improving airflow through the upper airway and reducing or even eliminating respiratory distress. For example, since the tongue is attached to the hyoid bone, lowering the hyoid bone can (i) pull the tongue downward / downward and prevent, or at least partially prevent, the tongue and / or related 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 dorsal side of the patient's pharynx and / or into the upper airway. Such movement of potentially obstructive tissues in the upper airway / pharynx is expected to improve the patient's sleep by reducing or eliminating obstruction. Other target tissues include the hypoglossal nerve or cervical nerve loop (e.g., one or more of the patient's infrahyoid girdle muscles, including the sternohyoid muscle and / or sternothyroid muscle), glossopharyngeal nerve, pharyngeal branches of the glossopharyngeal nerve, nerve plexuses, C2 and C3 spinal nerves, the lateral part of the epidural space at the C1, C2 and C3 vertebral bodies, pharyngeal branches 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, by applying a modulated signal directly to one or more parts of the cervical nerve loop and / or to one or more of the patient's oral cingulate muscles, it is possible to (i) move the patient's hyoid bone downward (e.g., caudal traction), (ii) increase the stiffness of the patient's pharyngeal wall and / or (iii) at least partially or completely prevent soft tissue collapse that, if not configured as described above, could cause an obstructive effect on the patient's upper airway.

[0014] Many embodiments of the technology described below may take the form of computer-executable, machine-executable, or controller-executable instructions, including routines executed by a programmable computer or controller. As those skilled in the art will understand, the technology can be implemented on computer / controller systems other than those illustrated and described below. The technology can be embodied in a special-purpose computer, controller, or data processor that is specifically programmed, configured, or set up to execute one or more of the computer-executable instructions described below. Thus, as used herein, “computer” and “controller” mean any appropriate data processor, and these terms may include Internet applications and handheld devices (such as palmtop computers, wearable computers, tablets, mobile phones, mobile phones, multiprocessor systems, processor-based consumer electronics, programmable consumer electronics, network computers, minicomputers, etc.). Information handled by these computers can be presented on any appropriate display medium, such as a liquid crystal display (LCD). In some embodiments, a manufacturer or other appropriate entity may provide instructions to the physician for performing the methods described herein. Manufacturers should also program the devices in the disclosure system to implement at least some of these methods.

[0015] This technology can also be implemented in a distributed environment, in which tasks or modules are executed by remote processing units linked to each other via a communication network. In a distributed computing environment, program modules or subroutines can be implemented in local or remote storage devices. The aspects of the technology described below can be stored on or distributed on any suitable computer-readable medium including one or more ASICs (e.g., with addressable memory), or distributed electronically via a network. Data structures and data transmission specific to the aspects of this technology are also included in the scope of embodiments of this technology.

[0016] 2. Overall patient physiological characteristics Representative embodiments described herein include a signaling device having electrodes that are preferably positioned to deliver one or more currents to one or more specific target locations, e.g., specific nerves and / or specific locations along nerves. Such locations include locations along the patient's cervical nerve loop, hypoglossal nerve, and / or vagus nerve. Additional locations include nerves innervating the muscles of the airway (e.g., palatine muscles, oropharyngeal muscles, laryngeal muscles, omohyoid muscle, sternohyoid muscle, sternothyroid muscle, thyrohyoid muscle, nasal muscles, tongue muscles, pharyngeal muscles, infrahyoid muscles, diaphragmatic muscles, and / or intercostal muscles). Target locations can be specified for any of intrinsic muscles, extrinsic muscles, associated nerve branches, and / or other physiological features, or any combination thereof.

[0017] Figure 1A shows patient P in a coordinate system where the x-axis represents the anterior-posterior direction (hereinafter referred to as "anterior-posterior"), the y-axis represents the upward-downward and / or cranial-caudal direction (hereinafter referred to as "cranial-caudal"), and the z-axis represents the medial-lateral direction. Patient P has a hard palate HP located above the tongue T, which forms the roof of the oral cavity (e.g., mouth). The hard palate HP has a bony support BS and thus does not normally deform during respiration. The soft palate SP, made of soft tissue such as membrane, fibrous tissue, adipose tissue, and muscle tissue, extends posteriorly (e.g., posteriorly) from the hard palate HP towards the back of the pharyngeal pharyngeal hemisphere. More specifically, the anterior end AE of the soft palate SP is fixed to the posterior end of the hard palate HP, while the posterior end PE of the soft palate SP is unfixed. Because the soft palate SP does not contain bone or hard cartilage, it can bend and may collapse into the back of the pharyngeal pharyngeal rhinoplasty (PHR) and / or flap back and forth (for example, especially during sleep).

[0018] The pharyngeal pharyngeal rhinopharynx (PHR) is the part of the throat that delivers air from the oral cavity (OC) and nasal cavity (NC) to the trachea (TR), located below the nasal cavity (NC), behind the oral cavity (OC), and above the esophagus (ES). The pharyngeal PHR is separated from the oral cavity (OC) by the palatolaryngeal arch (PGA), which extends downward on both sides toward the base of the tongue (T). Although not illustrated for simplification, the pharyngeal PHR includes the nasopharynx, velopharynx, oropharynx, and pharyngolarynx. The nasopharynx is located between the base of the skull and the soft palate (SP). The velopharynx is a segment of the nasopharynx whose ventral side is bounded by the soft palate. The oropharynx is located behind the oral cavity (OC) and extends from the soft palate (SP) to the pharyngeal epiglottic fold. The oropharynx opens anteriorly within the oral cavity (OC). The anterior wall of the oropharynx includes the base of the tongue (T). The epiglottis, a connective tissue flap, covers and closes the glottis (not shown for simplicity) to block inhalation when food is swallowed. The pharynx and larynx are the part of the pharynx that divides into the larynx anteriorly and the esophagus posteriorly, and are bordered superiorly by the pharyngeal epiglottic folds and inferiorly by the superior esophageal sphincter. Below the tongue T are the zoniformis orifice muscle, which controls the movement of the hyoid bone HB, as well as the mandible M and the geniohyoid muscle GH, one of its muscles, which controls the movement of the tongue T. Stimulation of one or more of the patient's zoniformis orifice muscles (and / or the nerves innervating one or more of the patient's zoniformis orifice muscles) can cause the hyoid bone AB to descend, including in the anterior or posterior directions, as indicated by the dashed arrows in Figure 1B, and can also produce corresponding movement of at least the base of the patient's tongue T. As will be explained in more detail below, lowering the base of the patient's tongue (T) can open the patient's airway and / or reduce or prevent tissue collapse that at least partially obstructs the patient's airway, thereby increasing airflow through the oral cavity (OC) and addressing OSA and / or other respiratory disorders.

[0019] Figure 1B is a schematic diagram of representative nerve structures and muscle tissues in the 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 cervical loop (AC) and associated branches originating from it innervate the omohyoid muscle (OHM), sternohyoid muscle (SHM), and sternothyroid muscle (STM). The cervical loop (AC) also preferably extends at least partially parallel to and / or around the patient's internal jugular vein (IJV). Figure 1B also shows the patient's mandible (M), mylohyoid muscle (MLH), and digastric muscle (DG) (more specifically, the anterior belly (ampulla) of the digastric muscle (DG), as well as the sternothyroid muscle (STM), sternocleidomastoid muscle (SCM), and sternohyoid muscle (SHM). The sternohyoid muscle (SHM) and sternothyroid muscle (STM) extend over the patient's larynx (L) (for example, anteriorly). The aforementioned muscles enter the patient's oral cavity (OC), cervical region (N), and / or shoulder (SH). By positioning and activating minimally invasive electrodes near at least one or more of the above-mentioned nerve structures and / or associated muscle tissues, as will be described in further detail below, embodiments of the present technique can control, reduce, and / or eliminate the effects of OSA.

[0020] Figure 1C is a schematic diagram of several arrangement states of the cervical nerve loop AC. Specifically, Figure 1C shows the medial arrangement state 101a, the lateral arrangement state (101b), and the mixed form (101c) of the cervical nerve loop AC. In each of these arrangement states, the cervical nerve loop AC has a superior root SR, a inferior root IR, a first branch B1 innervating the superior belly (OHMs) of the omohyoid muscle, a second branch B2 innervating the superior belly (OHMi) of the sternohyoid muscle and the inferior belly (OHMi) of the omohyoid muscle, and a third branch B3 supplying both the sternohyoid muscle (SHM) and the sternothyroid muscle (STM). More specifically, the third branch B3 may bifurcate into a first subbranch B3a innervating the sternothyroid muscle (STM) and a second subbranch B3b innervating the inferior belly (SHMi) of the sternothyroid muscle. The hypoglossal nerve (HGN), cranial nerves (C1-C3), internal jugular vein (IJV), and common carotid artery (CCA) are shown to illustrate the technical background. In medial alignment state 101a (left side), the inferior root (IR) extends posteriorly (e.g., after) the internal jugular vein (IJV). In lateral alignment state 101b (middle side), the inferior root (IR) is located anteriorly (e.g., before) the internal jugular vein (IJV). In mixed alignment state 101c (right side), the inferior root (IR) is located at least partially around the internal jugular vein (IJV), with the superior / superordinate portion of the inferior root (IR) extending posteriorly to the internal jugular vein (IJV) and the inferior / inferior portion extending anteriorly to the internal jugular vein (IJV). For each of these alignment states 101a-101c, the location and / or presence of the third branch (B3) and its subbranches (B3a, B3b) are expected to be at least entirely or identical. Therefore, the third branch B3 and / or its subbranch B3a,B3b are specific target locations of this technique, since at least these branches are expected to be easily identifiable and / or because the third branch B3 innervates numerous infrahyoid girdle muscles (e.g., the sternothyroid muscle STM and the infrabestos of the sternothyroid muscle SHMi). However, as will be understood by those skilled in the art, in practice, the system and method of this technique can still be used to address OSA in such patients by targeting other parts of the cervical nerve loop AC.

[0021] Figure 1D is a schematic partial view of representative nerve structures and muscle tissues of the mandible and neck of a patient, as well as a signaling device 100 positioned according to embodiments of the present technology. The signaling device 100 (as schematically shown) may have a housing 102, one or more electrodes 104, a signal generator 106, and an antenna 108. The housing 102 may have a first end portion 102a and a second end portion 102b opposite to the first end portion 102a. The individual electrodes 104 may be at least partially positioned on and / or around the second end portion 102a of the housing 102, for example. In some embodiments, the electrodes 104 may be masked (e.g., circumferentially masked), segmented (e.g., circumferentially segmented and individually accessible), directional, at least partially covered, and / or configured in different ways to direct the electric field in a particular direction. The signal generator 106 and antenna 108 are preferably positioned at least partially or completely within the housing 102, for example, at or near the second end portion 102b of the housing 102. The signal transmission device 100 is preferably fixed near or in a fixed position within at least one target nerve and / or muscle structure using one or more anchors, sutures, and / or other suitable devices.

[0022] To explain its function, the antenna 108 is preferably configured to wirelessly receive power signals (e.g., radio frequency "RF", inductive signals, etc.) from one or more devices located outside the patient P, such as one or more wearable devices. The RF power signal or at least a portion of the RF power signal may have frequencies in the range of about 300 MHz to about 6 GHz, for example, in the range of about 400 MHz to about 2.5 GHz, in the range of about 600 MHz to about 2.45 GHz, in the range of 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 may have frequencies in the range of about 100 kHz to about 14 MHz, such as, for example, about 135.7 kHz, about 6.5 MHz, about 13.5 MHz, and / or other suitable frequencies and / or frequency ranges. In these embodiments and / or other embodiments, the wireless power signal, or at least a portion of the wireless power signal, may have a frequency or frequency range that is in the industrial, scientific, and medical frequency bands ("ISM bands").

[0023] The power received at antenna 108 is preferably sent to signal generator 106, which uses this power to generate one or more electrical pulses or signals. In at least some embodiments, the power received at antenna 108 (e.g., AC power) is rectified to DC (e.g., via an AC-DC converter) and then sent to a DC-DC converter, a charge pump, and / or a transformer. In some embodiments, the power is converted into pulses having frequencies in the range of about 10 Hz to about 100 Hz, for example, in the range of about 30 Hz to about 300 Hz. In other embodiments, the pulses are preferably sent at a higher frequency (e.g., 10 kHz or higher) and / or in the form of bursts. The amplitude of the signal is preferably about 1 mV to about 5 V (1 V to 2 V in certain embodiments) in voltage-controlled systems, or about 0.5 mA to about 12 mA in current-controlled systems. The pulse width may be approximately 10 μs to approximately 1000 μs, for example, at least 10 μs, 50 μs, 100 μs, 150 μs, 250 μs, 500 μs, or another appropriate pulse width. In the illustrated embodiment, all signal generation is performed by signal generator 106, while in other embodiments, some signal generation functions may be performed by external elements. The signal generation and signal emission functions can be performed by a single signal transmission device or a number of devices.

[0024] The signal generated by the signal generator 106 is preferably sent to one or more of the electrodes 104, which are preferably sent to a target nerve and / or muscle structure. The electric field generated by the current sent by the electrodes 104 produces a desired effect (e.g., excitation and / or inhibition) at the target nerve. In at least some embodiments, the signal transmission device 100 does not need to have an onboard power storage element (e.g., a power capacitor and / or battery) or any storage element with a storage capacity of more than 0.5 seconds in order to reduce the system volume. In other embodiments, the signal transmission device 100 may have one or more small charge storage devices (e.g., low-voltage high-capacitance capacitors, solid-state batteries, and / or others) that are compatible with the overall compact form of the signal transmission device 100 and have a total charge storage capacity of 1 second or less, 5 seconds or less, 10 seconds or less, 15 seconds or less, 20 seconds or less, 25 seconds or less, 30 seconds or less, 1 minute or less, 2 minutes or less, 5 minutes or less, any period between these periods, or another appropriate period, depending on the embodiment. In another embodiment, the signaling device 100 has one or more power storage elements configured to store charge for an extended period. Such a signaling device 100 is preferably configured for a wearable device that omits a power transmission device. In at least some embodiments, the modulated signal sent to the patient is preferably sent via a dipole formed by two of the electrodes 104. In other embodiments, the signaling device is preferably monopole, and at least a portion of the housing 102 (e.g., the first end portion 102a of the housing 102) forms a ground or return electrode, and / or the ground electrode is located somewhere else (e.g., subcutaneously, outside the patient, etc.). In these embodiments and other embodiments, the modulated signal may include a single-phase waveform, a two-phase and / or charge-balanced waveform, and / or another suitable waveform.

[0025] The signaling device 100 may have additional onboard components and / or functions. In some embodiments, the signaling device 100 may include, for example, one or more sensors. These sensors may include motion sensors configured to detect respiratory arrest / snoring / respiration depression, movement, and / or vibrations caused by the patient's posture. The sensors may also include respiratory rate sensors, respiratory amplitude sensors, heart rate sensors, SpO2 sensors, and / or one or more other sensors configured to detect information related to the patient's respiration and / or sleep state. The data obtained by the sensors may be processed outside the signaling device 100 and / or transmitted to an external control unit, for example, to enable the generation of a modulated signal based on the detected data in a closed loop of the signaling device 100 and / or at least one of them.

[0026] A single signaling device 100 is shown in Figure 1D, but in some embodiments, one or more additional signaling devices may be positioned to transmit modulated signals to (i) other parts of the cervical nerve loop AC, (ii) one or more branches of the cervical nerve loop, and / or (iii) one or more of the patient's infrahyoid genu thoracic muscles. Further details regarding the positioning of the signaling devices will be described below with reference to Figures 2A to 9B.

[0027] 3. Typical insertion routes and target tissues Referring to Figures 2A to 9B, several modulation targets and implantation techniques are described and / or illustrated. For clarity, these modulation targets and implantation techniques are illustrated with respect to the left or right side of the patient P's anatomical structure, for example, the first or left cervical loop and / or the first or left infrahyoid velvet girdle of patient P. However, as can be understood, at least some or all of the modulation targets and / or implantation techniques described and / or illustrated with reference to Figures 2A to 9B are equally suitable for application to the other side of the patient's anatomical structure, for example, the second or right left cervical loop and / or the second or right infrahyoid velvet girdle of patient P. In addition, 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 point, and a second modulation signal to a second modulation target on a second side of patient P opposite to the first side, at the same time point or at 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 stimulation targets may be the left and right corresponding parts of the patient's anatomical structure, for example, the first and second parts of the left and right cervical loops. In other embodiments, the first and second modulation targets may be different from each other, for example, the patient's left cervical loop and the patient's right infrahyoid vein ligament.

[0028] Current surgical device placement methods for treating OSA target the hypoglossal nerve, but approximately 35–45% of patients receive little to no positive effect from the treatment / signals delivered to this target. Furthermore, many patients considered responders to hypoglossal nerve modulation still exhibit a residual respiratory arrest-respiratory depression index ("AHI"). Even after optimizing the modulation setting, these patients experience only a 50–70% reduction in their AHI, indicating that they still experience respiratory arrest and / or depression during and / or after hypoglossal nerve modulation therapy. These patients may also experience unwanted awakenings, tongue abrasion, snoring, and / or other side effects of hypoglossal nerve modulation therapy, and such therapy is expected to reduce patient compliance with both of these—for example, user compliance with current methods is less than 80%.

[0029] Furthermore, current OSA treatments stimulate the base of the posterior portion of the tongue but do not strengthen the rest of the airway. While the airways of many OSA patients exhibit retrolingual collapse (e.g., collapse at the base of the tongue), almost all patients with OSA exhibit posterior palatal (e.g., velopharyngeal and / or reposterior pharyngeal) tissue collapse. Hypoglossal nerve modulation may not be effective in increasing airway patency at the posterior palatal level in all patients. Cervical nerve loop AC modulation is expected to improve (e.g., reduce) airway collapse in the posterior palatal region without adversely affecting the ability of hypoglossal nerve modulation to reduce or prevent posterior palatal collapse. Therefore, cervical nerve loop AC modulation, either alone or in combination with hypoglossal nerve modulation, is expected to provide a therapeutic solution for widespread upper airway collapse sites, resulting in (1) a more effective treatment for patients whose collapse patterns (e.g., posterior palate) are not fully targeted by hypoglossal nerve modulation alone, and (2) an expansion of the potential population for which nerve modulation may be an effective treatment by targeting additional collapse sites. While cervical nerve loop modulation is expected to improve or even correct respiratory disorders on its own, the combination of cervical nerve loop AC and hypoglossal nerve modulation is expected to yield a greater effect and / or increase the importance of the therapy in a different way compared to cervical nerve loop AC modulation therapy alone or hypoglossal nerve modulation therapy alone (e.g., it can treat severe collapse). This may enable the treatment of patients with high body mass index (BMI) and / or patients with high airway collapse, such as patients with high therapeutic CPAP values.

[0030] Stimulation of one or more of the cervical nerve loops (AC) and / or the patient's infrahyoid vein muscles is expected to move the hyoid bone downward by contracting the infrahyoid vein muscles, resulting in a caudal traction force. Caudal traction force has been described in the literature as a mechanism that strengthens one or more tissues that make up the patient's upper airway (e.g., glottis, vocal cords, etc.) and / or, in a different way, enhances the upper airway capacity to at least partially address the symptoms of OSA. For example, by lowering the hyoid bone, the tongue, or at least the posterior portion of the tongue, can change its position relative to the patient's airway without causing, or with little to no, contraction of the tongue muscles. For example, by lowering the hyoid bone, the tongue can be stretched downward, thereby opening (or further opening) the patient's airway (or at least the posterior palatal portion of the patient's airway) and increasing the airflow through the patient's airway. Also, stimulation of the hypoglossal nerve and / or genioglossus muscle is expected to contract the posterior portion of the tongue. Another effect of pharyngeal wall strengthening is that contraction of the infrahyoid genu girdle muscle occurs over the upper airway, which can complement the caudal traction force. Therefore, the cervical nerve loop can, on its own, improve or even completely repair the patient's airflow obstruction.

[0031] Combination therapies (e.g., techniques targeting the cervical loop of the genioglossus (AC) and the hypoglossal nerve, and / or one or more muscles innervated by these nerves) are expected to provide numerous physiological responses that reduce or prevent airway obstruction in patients. For example, using a combination of infrahyoid girdle muscle contraction and genioglossus muscle contraction is expected to prevent or at least partially prevent multi-site collapse of posterior palate collapse and posterior tongue collapse by addressing them, for example, simultaneously and / or complementary physiological responses. Such infrahyoid girdle muscle contraction can be achieved, for example, by modulation of the cervical loop of the genioglossus (AC), modulation of the infrahyoid girdle muscle, and / or modulation of the motor endplate, and such genioglossus muscle contraction can be achieved by modulation of the hypoglossal nerve, direct modulation of the genioglossus muscle, and / or modulation of the motor endplate. Therefore, combination therapy is expected to improve outcomes for patients who have already responded to a single target modulation (e.g., cervical loop or hypoglossal nerve) but still have respiratory distress (e.g., after cervical loop modulation, residual postlingual collapse, hypoglossal nerve stimulation, postlingual stenosis / collapse, and / or residual snoring / AHI). For example, embodiments of this technology are expected to reduce the number and / or frequency of respiratory arrest and / or de-respiratory events occurring in patients over a period of time, for example, during and / or after modulation signal delivery. Additionally or alternatively, multi-site nerve delivery is expected to increase the number of potential patients as responders, including patients who would not respond to target modulation alone if not configured as such. This includes patients who have already received hypoglossal nerve stimulation but exhibit major posterior palate (e.g., velopharyngeal) collapse, soft palate junction, BMI > 32, and / or complete concentric airway collapse.

[0032] In some embodiments, the combination of cervical nerve wrapa AC and hypoglossal nerve modulation is expected to reduce patient arousal by reducing or blocking excessive modulation, for example, of the base of the tongue (which may be guided to accompany the soft palate). For example, positioning the signaling device to target a group of multiple nerves / muscles can provide effective therapy while activating one or more of the devices with less amplitude than would be required if only one nerve / muscle group were targeted. Additionally or alternatively, positioning multiple signaling devices to target selected nerves / muscles can provide effective therapy while eliciting only a partial contraction / motor response from one or more of the associated muscles. By reducing the effective therapeutic amplitude and / or motor response at one or more target modulation sites, embodiments of this technology are expected to produce a low number of patient arousal without threatening or substantially threatening the effective physiological response. As a result, this approach can improve patient compliance, overall therapeutic efficacy, and / or the quality of the patient's sleep.

[0033] Additional details relating to the technique for positioning the signaling device to transmit modulated signals to the cervical nerve loop will be described with reference to Figures 2A to 9B. Additional details relating to positioning the signaling device to transmit modulated signals to the hypoglossal nerve are described in U.S. Patent Application No. 18 / 393,537, filed December 21, 2023, which is incorporated herein by reference and whose entire contents are part of this specification.

[0034] Figure 2A is a lateral cross-sectional view of a portion of a patient's upper airway, showing a signaling device 100 positioned at a target location near at least one or more target tissues according to embodiments of the present technology. In the illustrated embodiment, the target location is located above the third branch B3 of the cervical nerve loop AC. In these embodiments and / or other embodiments, the target location is preferably located near at least one other portion of the cervical nerve loop AC. When positioned at least near the target tissue, the signaling device 100 is preferably located at a distance of about 10 mm to about 0.01 mm from the target tissue, for example, (i) up to 9 mm, up to 8 mm, up to 7 mm, up to 6 mm, up to 5 mm, up to 4 mm, up to 3 mm, up to 2 mm, up to 1 mm, or up to 0.1 mm from the target tissue, (ii) in contact with at least a portion of the target tissue, (iii) within any of these distances, or (iv) at another suitable distance from the target tissue.

[0035] The signal transmitting device 100 is preferably positioned toward the target location via an insertion path 210 that extends medially-laterally and posteriorly from at least near the midline or midsagittal plane of patient P. One or more of the electrodes 104 are preferably positioned to transmit signals to target tissue at or at least near the cervical nerve loop, thereby generating a caudal traction force and / or being incorporated into the patient's OSA in a different manner.

[0036] In the illustrated embodiment, the insertion path 210 is used to position the signal transmission device 100 perpendicular to the central sagittal plane, or at least perpendicular as a whole, for example, parallel to the transverse or x-z plane, or at least substantially parallel as a whole. In other embodiments, the insertion path 210 is preferably used to position the signal transmission device 100 such that at least one component of its orientation (vector component) is aligned along the downward-upward (hereinafter referred to as "upward-downward") / head-to-tail (hereinafter referred to as "head-to-tail") axis. In such embodiments, the signal transmission device 100 is not positioned only parallel to the x-z plane. Instead, one component of the orientation of the signal transmission device 100 (for example, a significant vector component) is preferably aligned along the y-axis. For example, as will be explained in more detail below with reference to Figures 5A and 5B, the first end portion 102a of the signal transmission device 100 is preferably positioned above the second end portion 102b of the signal transmission device 100, or the second end portion 102b is preferably positioned above the first end portion 102a.

[0037] In some embodiments, the insertion site or opening 212 is preferably formed within the patient's neck N, at least near the middle sagittal plane, and the signaling device 100 is preferably moved through this opening 212 and along the insertion path 210. In the illustrated embodiment, the opening 212 is a subcutaneous opening formed using a percutaneous or other minimally invasive insertion tool 214, such as a needle (e.g., a subcutaneous injection needle), a stylet, an introducer, a dilator, and / or a trocar, without performing excision of the submental region SM. Additionally or alternatively, the subcutaneous insertion tool 214 can be used to position the signaling device 100 within the patient's body, for example by projecting the signaling device 100 outward from within the subcutaneous insertion tool 214 or releasing the signaling device 100 from the subcutaneous insertion tool 214 in a different manner, when the signaling device 100 is positioned at least near the target location.

[0038] At least a portion of the signaling device 100 (for example, a second end portion 102b) is preferably positioned posterior to one or more of the patient's infrahyoid girdles muscles (for example, the sternohyoid muscle SHM, the sternothyroid muscle STM, and / or the omohyoid muscle OHM). For example, the opening 212 is preferably formed in or near the middle sagittal plane, and the insertion path 210 is preferably extended posterior to the sternohyoid muscle SHM, the sternothyroid muscle STM, and / or the omohyoid muscle OHM without penetrating or substantially penetrating one or more of the infrahyoid girdles muscles. Additionally or alternatively, the insertion path 210 is preferably extended anterior to one or more of the sternohyoid muscle SHM, the sternothyroid muscle STM, and / or the omohyoid muscle OHM. In these embodiments and / or other embodiments, the insertion path 210 may 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 part of the delivery device 100 may be positioned between and / or within the individual infrahyoid girdle muscles.

[0039] Figure 2A also schematically shows a portion of a typical ultrasound probe 201, which can be used to identify the location where the opening 212 should be formed, identify the target location, move the signaling device 100 along the insertion path 210, and / or position the signaling device 100 in a different manner at least near the target location. The ultrasound probe 201 can be used to visualize the target location, the signaling device 100, and / or the subcutaneous insertion tool 214 before, during, and / or after the procedure to position the signaling device 100 at least near the target location. In such embodiments, aligning the orientation of the signaling device 100 and the ultrasound probe 201 is expected to increase the speed and / or accuracy of positioning the signaling device 100. In these embodiments and other embodiments, the ultrasound probe 201 can be used to position the signaling device 100 at or near the target location. The signaling device 100 (or, in some embodiments, the insertion tool 214) sends a modulated signal throughout all or part of the implantation process so that the attending physician can observe the patient's response to the modulated signal and thereby confirm, for example, that the signaling device 100 is located at or near the target location and / or signal for further adjustment to the positioning of the signaling device 100. This is described in detail in U.S. Patent Application No. 17 / 666,464 and U.S. Patent Application No. 18 / 104,739, which are incorporated herein by reference and whose entire contents are part of this specification.

[0040] In the insertion path 210 shown in Figure 2A, the insertion path 210 extends in an inward direction, but in other embodiments, the insertion path 210 may extend in an outward-inward direction, for example, in the opposite direction to the illustrated insertion path 210 and / or toward the patient's mid-sagittal plane. In such embodiments, the opening 212 is preferably formed at a position spaced outward from the location of the target.

[0041] Figure 2B is a cross-sectional view of the patient's neck N at the third cervical vertebra, showing an example of the angular insertion range 215 according to various embodiments of the present technology. The insertion range 215 is preferably determined with respect to the sagittal or x-y plane of the patient P, the coronal 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. With respect to a given location, for example, the cervical nerve loop AC, the patient's trachea TR can partially define the innermost limit of the insertion range 215. In the illustrated embodiment, the internal jugular vein IJV defines the outermost limit of the insertion range 215, but in other embodiments, the external jugular vein EJV, common carotid artery CCA, and / or vagus nerve VG can partially define the outermost limit of the insertion range 215. The insertion range 215 may be wider or narrower than the illustrated insertion range at different vertebral height positions or levels (e.g., C2, C4, C5, C6, C7, T1, etc.). The insertion range 215 is preferably within an angle of up to 180°, up to 170°, up to 135°, up to 90°, up to 45°, up to 15°, up to 5°, or any angle range between these values. In some embodiments, the preferred insertion path is within a range of 5°, 10°, 20°, 30°, 45°, or 90° from the innermost or outermost limit of the insertion path 215 range. Although the insertion path 215 is shown on the left side of patient P, as will be understood by those skilled in the art, the signaling device can be positioned on the right side of patient P using the same or at least substantially the same insertion range.

[0042] Figure 2C is a cross-sectional view showing the insertion path 210' according to various embodiments of the present technology. The insertion path 210 is preferably a straight path or at least a nearly straight insertion path within the angular insertion range 215 of Figure 2B. For example, the insertion path 210 is preferably at an angle of about 0° to about 135°, for example, about 45° to about 80°, about 60° to about 80°, or, in a particular patient, at an angle A (in the transverse or x-z plane and / or with respect to the middle sagittal plane) which is another angle that avoids the airway, internal jugular vein (IJV), external jugular vein (EJV), common carotid artery (CCA) and / or vagus nerve (VG). The insertion route 210 is preferably used to at least partially or completely penetrate one or more of the infrahyoid girdle muscles (e.g., sternohyoid muscle SHM, sternothyroid muscle STM, and / or omohyoid muscle OHM) and / or the sternocleidomastoid muscle SCM, and / or to position the signaling device 100 at least partially posterior to and / or within the patient's sternocleidomastoid muscle SCM. An insertion route 210 that is at least substantially linear is expected to improve the speed and / or accuracy at which the signaling device 100 can be positioned at least near the target location (e.g., by a medical technician) by minimizing or eliminating the need to reorient the signaling device 100 during insertion. An insertion route 210 that goes from medial to lateral is expected to enhance patient safety by, for example, reducing or preventing trauma to the patient's vascular system, such as the internal jugular vein IJV. For example, as shown in Figure 2C, the internal jugular vein (IJV) is located posterior to the cervical nerve loop AC, and the insertion path 210 can position the signaling device 100 at least near the cervical nerve loop AC, so that the signaling device 100 reaches the depth where the internal jugular vein (IJV) is located. Additionally or alternatively, the angle of the insertion path 210 may be selected to avoid bypassing the internal jugular vein (IJV) or positioning the internal jugular vein (IJV) along the insertion path 210 in a different manner. In some embodiments, by inserting and / or implanting the signaling device in a manner that avoids the patient's internal jugular vein (IJV) and / or other vessels, it is possible to prevent, or at least partially prevent, the transmission of modulated signals to the patient's vessels that may cause undesirable vasodilation and / or vasoconstriction.In some embodiments, the signaling device can be inserted and / or implanted in a manner that avoids the patient's internal jugular vein (IJV) and / or other blood vessels, thereby preventing, or at least partially preventing, the signaling device from being positioned in contact with the patient's blood vessels, thereby reducing or preventing erosion or weakening of vascular tissue (e.g., due to contact / friction between the signaling device and the blood vessel).

[0043] Figure 2D is a cross-sectional view showing another insertion path 210″ according to embodiments of the present technology. The insertion path 210a may include a plurality of insertion path segments or portions 216a, 216b that are angled 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 makes a first angle A1 in the transverse or x-z plane with respect to the middle sagittal plane. The second path portion The portion 216b is preferably forming a second angle A2 in the transverse plane or in the x-z plane with respect to the central sagittal plane and / or a third angle A3 in the transverse plane or in the x-z plane with respect to the first path portion 216a. The first angle A1, the second angle A2, and / or the third angle A3 are preferably between approximately 0° and approximately 135°, for example, approximately 45° and approximately 80°, approximately 60° and approximately 80°, or any suitable angle between these values ​​or another suitable angle. Additionally or alternatively, the first angle A1 may form a second angle A2 and The second angle A2 may be smaller or larger than the first angle A1 and / or the third angle A3, and / or the third angle A3 may be smaller or larger than the first angle A1 and / or the second angle A2. Each of the insertion path portions 216a, 216b may be associated with a change in the orientation of the signaling device 100 (for example, by the physician during insertion). In at least some embodiments, Each of the insertion path portions 216a and 216b has one or more vector components aligned along an axis from the inside to the outside (e.g., the z-axis) and / or an axis from the front to the back (hereinafter referred to as "front-back") (e.g., the y-axis), which is expected to (i) reduce or minimize changes in the orientation of the signal delivery device 100 during insertion and (ii) increase the speed and / or accuracy at which the signal delivery device 100 can be positioned at least near the target tissue. In other embodiments, one or more of the insertion path portions may have other suitable alignments.

[0044] Figure 2E is a cross-sectional view showing yet another insertion route 210'″ according to embodiments of the present technology. The insertion route 210'″ is preferably a straight route or at least substantially straight route within the angular insertion range 215 of Figure 2B. For example, the insertion route 210'″ may begin at an opening 212' formed laterally and / or anteriorly to the external jugular vein (EJV), and may extend anteriorly, laterally-medially, and inward toward the cervical nerve loop (AC). The insertion route 210'″ may at least partially or completely penetrate the patient's sternocleidomastoid muscle (SCM). Such an lateral-medial insertion route 210′″ is expected to reduce or prevent trauma to the patient's vascular system and / or enhance patient safety. For example, using the insertion route 210′″, the clinician or other user should advance the signaling device 100 toward the cervical nerve trap AC without the insertion route 210′″ crossing, or substantially crossing, one or more of the patient's blood vessels located near the cervical nerve trap AC (e.g., the external jugular vein EJV, the internal jugular vein IJV, etc.), or even without directing, or substantially directing toward, one or more of such vessels. This simplifies navigation toward the cervical nerve trap AC because it reduces the risk of over-inserting the signaling device 100 along the insertion route 210′″ and perforating the patient's vascular system.

[0045] As shown in Figures 2C to 2E, the signal transmitter 100 is positioned at least partially posteriorly to one or more muscles in the patient's neck N (e.g., the sternocleidomastoid muscle SCM). Since it is only subcutaneously positioned, the signal transmitter 100 will be visible beneath the patient's skin, which the patient may not find desirable, and / or the patient may be able to physically manipulate the signal transmitter 100, thereby changing its position relative to the target tissue. However, in the at least partially submuscular positioning shown in Figures 2C and 2D, for example, the signal transmitter 100 is not expected to be visible and / or operable to the patient.

[0046] Figures 3A and 3B are frontal and lateral cross-sectional views, respectively, of a portion of the patient's neck and mandible, which illustrate the angular range 318 of the downward-upward component of the medial-to-lateral approach for inserting the signal delivery device 100 according to embodiments of the present technology. The angular range 318 is preferably defined, for example, in the transverse or x-z plane of patient P, and / or with respect to one or more suitable anatomical structures and / or reference features of patient P. With respect to a given target location, the patient's jaw J and / or hyoid bone HB can at least partially define the upward-maximum limit of the insertion path range 318. The clavicle CL and / or shoulder SH can at least partially define the lowest limit of the insertion path range 318. In some embodiments, preferred insertion routes bisect the range 318 of the insertion route, or are within ±20°, ±15°, ±10°, ±5°, ±1°, or, in certain patients, form other angles that avoid the airway TR (Figure 2B), internal jugular vein IJV (Figure 2B), external jugular vein EJV (Figure 2B), common carotid artery CCA (Figure 2B), and / or vagus nerve VG (Figure 2B). Manipulating the patient's neck N and / or jaw J can widen the angle range 318. For example, the physician can rotate or curl the patient's jaw J posteriorly to improve access to the neck N and / or mandible. Additionally or alternatively, the physician can utilize a wider insertion route range than the angle range 318 shown in Figures 3A and 3B using a shorter insertion tool or needle, such insertion routes include vertically aligned insertion routes and / or implantation orientations, for example, as will be described in detail below with reference to Figures 5A and 5B.

[0047] Figures 3C and 3D are frontal and lateral cross-sectional views, respectively, of a portion of the patient's neck and mandible, which show the angular range 318' of the lower-upper component of the lateral-medial approach for inserting the signal delivery device 100 according to embodiments of the present technology. The lower and / or upper limits of the angular range for the lateral-medial approach are preferably determined by the same or at least substantially the same anatomical structures as those for the medial-lateral approach described above with reference to Figures 3A and 3B. For example, with respect to a given target location, the patient's jaw J and / or hyoid bone HB can at least partially define the upper limit for the range 318' of the insertion path, and the clavicle CL and / or shoulder SH can at least partially define the lower limit for the range 318' of the insertion path. In some embodiments, preferred insertion routes bisect the range 318′ of the insertion route, or are within ±20°, ±15°, ±10°, ±5°, ±1°, or, in certain patients, form other angles that avoid the airway TR (Figure 2B), internal jugular vein IJV (Figure 2B), external jugular vein EJV (Figure 2B), common carotid artery CCA (Figure 2B), and / or vagus nerve VG (Figure 2B). Manipulating the patient's neck N and / or jaw J can widen the angle range 318′. For example, the attending physician can rotate or curl the patient's jaw J posteriorly to improve access to the neck N and / or mandible. Additionally or alternatively, the physician may use a shorter insertion tool or needle to utilize an insertion path range wider than the angular range 318′ shown in Figures 3C and 3D, such insertion paths including vertically aligned insertion paths and / or implantation orientations, for example, as will be described in detail below with reference to Figures 5A and 5B.

[0048] Figures 4A to 48 show additional locations where the signaling device 100 can be implanted. Figures 4A to 48 show the signaling device 100 in a specific orientation and positioned proximal to at least one or more specific target tissues, and as will be understood by those skilled in the art, the signaling device 100 can also be positioned in other orientations and / or at other target tissues.

[0049] Referring to Figure 4A, the signal transmitter 100 is oriented at least anterior-posteriorly as a whole and is positioned at least proximal to the branch B1 of the cervical nerve loop AC that innervates the superior root SR and / or the superior belly (ampulla) of the omohyoid muscle OHM. In this position, the signal transmitter 100 is preferably configured to transmit a modulated signal to at least one or both of the superior root SR and / or branch B1, based on which of the electrodes 104 is activated. In the medial-to-lateral orientation shown in Figure 4A, the first end portion 102a and the second end portion 102b are preferably in the same or at least approximately the same downward-upward position relative to each other, so that, for example, the orientation of the signal transmitter 100 does not include a vector component angled in the downward-upward direction.

[0050] Referring to Figure 4B, the signaling device 100 is in a position and orientation that is at least substantially the same as that described above with reference to Figure 4A. However, in the anterior-posterior orientation shown in Figure 4B, the first end portion 102a is positioned anterior to the second end portion 120b, and therefore, for example, the first signaling device 100 is positioned to send a modulated signal to motor site MP, which innervates the superior belly of the omohyoid muscle OHM and the superior portion of the sternohyoid muscle SHM, via a branch B1 of the cervical nerve loop AC. Motor site MP is the point where the motor nerve / nerve loop AC first penetrates the relevant muscle belly, and the location of the muscle most sensitive to electrical modulation is the terminal of the motor nerve fiber. It is preferable that motor site MP includes one or more anterior branches AB, each innervating an individual muscle fiber. It is preferable that one or more of the anterior branches AB be stimulated separately and independently to produce a motor response of the corresponding muscle fiber. For example, as shown in Figure 4C, the signaling device 100 may be positioned across or laterally to the anterior branch AB, so that when various combinations of electrodes 104 are activated, modulated signals can be sent to individual parts of the anterior branch AB. As described with reference to the omohyoid muscle OHM, as will be understood by those skilled in the art, the cervical loop AC has motor sites MP and anterior branches AB at the location where the cervical loop AC innervates other infrahyoid girdle muscles. As a result, one or more signaling devices may be positioned to send modulated signals to one or more of the other motor sites.

[0051] Referring together to Figures 4A and 4B, in order to implant the signaling device 100 in these positions and / or orientations, the signaling device 100 is preferably inserted into the patient's body in a front-to-rear direction or a rear-to-front direction. In either case, the first end portion 102a can lead to the second end portion 102b, or the second end portion 102b can lead to the first end portion 102a.

[0052] Referring to Figure 5A, the signal transmitter 100 is oriented at least in a nearly downward-upward direction and is positioned at least near the common branch B3 of the superior root and / or cervical nerve loop AC. More specifically, the signal transmitter 100 is aligned with the downward-upward axis and, for example, when viewed perpendicular to the patient's sagittal plane, is positioned on the common branch B3 and at least partially posterior to one or both of the partial branches B3a, B3b that innervate the sternohyoid muscle. At this position, the signal transmitter 100 is preferably configured to transmit a modulated signal to the superior root SR and / or common branch B3 based on which of the electrodes 104 is activated. In the downward-upward orientation shown in Figure 5A, the first end portion 102a is positioned above the second end portion 102b such that the orientation of the signal transmission device 100 aligns with the downward-upward direction and / or includes a vector component that is parallel to, or at least substantially parallel to, the upper root SR.

[0053] Referring to Figure 5B, the signal transmitter 100 is in substantially the same position and orientation as described above with reference to Figure 5A. However, in the downward-upward orientation shown in Figure 5B, the first end portion 120a is positioned below the second end portion 102b such that the orientation of the signal transmitter 100 aligns with the downward-upward orientation and / or includes a vector component parallel to, or at least substantially parallel to, the upper root SR. In this position, the signal transmitter 100 is preferably configured to transmit a modulated signal to one or both of the partial branches B3a, B3b that innervate the sternothyroid muscle (STM) and the sternohyoid muscle (SHM), based on which of the upper root SR, the common branch B3, and / or at least one of the electrodes 104 is activated.

[0054] Referring together to Figures 5A and 5B, in order to implant the signaling device 100 in this position and / or orientation, the signaling device 100 is preferably inserted into the patient's body in a downward-upward or upward-downward direction, with the first end portion 102a leading to the second end portion 102b, or the second end portion 102b leading to the first end portion 102a. Positioning the signaling device 100 in the downward-upward orientation shown in Figures 5A and 5B is expected to offer several advantages. For example, since at least a portion of the cervical loop extends at least substantially parallel to the patient's internal jugular vein (IJV) (Figure 1B), medical technicians can avoid puncturing or piercing the internal jugular vein (IJV), and the internal jugular vein (IJV) can be used as a navigation landmark to help position the signaling device 100 at least near the cervical loop AC. Additionally or alternatively, since at least a portion of the cervical nerve loop AC extends in a substantially downward-upward direction, the signaling device 100 is preferably positioned in a downward-upward direction at least substantially parallel to the cervical nerve loop without changing or substantially changing the orientation of the signaling device 100 during transmission (as described above herein with reference, for example, to Figures 2C and 2D).

[0055] Figures 6A to 6D show signaling devices 100 positioned near the third branch B3 of the cervical nerve loop AC, according to various embodiments of the present technology. Generally, targeting the third branch B3 (and / or one or both of its subbranch B3a, B3b) is expected to reduce or prevent trauma to the patient's internal jugular vein and / or central carotid artery, taking into account the distance between the third branch B3 and the patient's internal jugular vein and / or central carotid artery. Additionally or alternatively, targeting the third branch B3 is expected to inhibit or even prevent vagus nerve modulation, taking into account the distance between the third branch B3 and the vagus nerve.

[0056] Referring to Figure 6A, the signal transmitter 100 is positioned at least substantially parallel to the third branch B, with at least a portion of the signal transmitter 100 positioned medially to the omohyoid muscle (OHM). In this position, the electrode 104 can transmit a modulated signal to the third branch B3, and can produce a motor response in both the sternohyoid muscle (SHM) and the sternothyroid muscle (STM).

[0057] Referring to Figure 6B, the signaling device 100 is positioned such that the electrode 104 is at least partially located between the first subbranch B3a and the second subbranch B3b of the third branch B3. In this position, the signaling device 100 can selectively send a modulated signal to one or both of the first and second subbranch B3a, B3b to selectively induce a motor response in one or both of the sternohyoid muscle (SHM) and the sternothyroid muscle (STM). For example, the individual electrodes 104 may be segmented or masked, and may also be configured to send the modulated signal upward / upward (e.g., towards the first subbranch B3a) or downward / downward (e.g., towards the second subbranch B3b).

[0058] Referring to Figure 6C, the signal transmission device 100 is positioned across (for example, laterally to) the first and second branches B3a and B3b. In this position, activating various combinations of electrodes 104 allows for the selective transmission of a modulated signal to one or both of the first and second subbranches B3a and B3b, thereby selectively inducing 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 two lower electrodes to transmit the modulated signal to the second subbranch B3b, and / or an electric field can be generated between the two upper electrodes to transmit the modulated signal to the first subbranch B3a.

[0059] Referring to Figure 6D, the signal transmitter 100 is positioned along the second portion B3b. At this position, activating various combinations of electrodes 104 allows the modulated signal to be selectively delivered to the motor end plate, which is the location where the second portion B3b innervates the sternohyoid muscle SHM (e.g., the inferior belly SHMi of the sternothyroid muscle, Figure 1C), thereby selectively inducing a motor response in the sternohyoid muscle SHM. In other embodiments, the signal transmitter 100 may be positioned to deliver the modulated signal to one or more locations along the length of the cervical nerve loop AC, between the start of the third branch B3 and the location where the second portion B3b innervates the sternohyoid muscle SHM.

[0060] The position and orientation of the signal transmitter 100 in Figures 2A to 6D are briefly described in relation to positioning the signal transmitter 100 near at least the cervical nerve loop and / or one or more parts and / or branches thereof. In other embodiments, any of the insertion routes described herein (or at least one or more parts thereof) can be used to position the signal transmitter 100 near at least one or more other target tissues, for example, near one or more of the patient's infrahyoid velvet muscles. For example, additional embodiments relating to the patient's infrahyoid velvet muscles will be described later with reference to Figures 7A to 9B.

[0061] Generally, modulated signals applied to nerves, including the cervical nerve loop (AN), have a characteristic neuromuscular activation threshold (e.g., minimum amplitude) associated with eliciting an evoked motor response in the tissue innervated by the nerve. Often, there is little to no motor response elicited before the neuromuscular activation threshold is met. After the neuromuscular activation threshold is met or exceeded, further changes to the modulated signal (e.g., further increases in output energy) often produce little to no additional motor response. This makes it difficult to gradually induce a motor response over time. One approach to address this problem is to apply the modulated signal directly to the muscle associated with the motor response of interest. For example, by directly applying the modulated signal to one or more of the patient's infrahyoid girdle muscles (e.g., sternohyoid muscle (SHM), sternothyroid muscle (STM), omohyoid muscle (OHM), and / or thyrohyoid muscle (THM)), the same muscles will be activated as when the modulated signal is applied to one or more parts / branches of the cervical nerve loop (AC). This allows for a more gradual dose-response activation by restoring individual muscle fibers, compared to, for example, the activation of nerves / branchs innervating the infrahyoid velvet girdle muscle. For example, a first motor response can be produced by applying a first modulated signal having one or more first signaling parameters (e.g., amplitude, frequency, pulse width, etc.) to the infrahyoid velvet girdle muscle at a first time point, and a second motor response having different (e.g., greater or smaller) degree of movement, velocity, range of motion, and / or momentum can be produced by applying a second modulated signal having one or more second signaling parameters different from one or more first signaling parameters to the infrahyoid velvet girdle muscle at a second time point. In some embodiments, the first signaling parameter may be a first amplitude, and the second signaling parameter may be a second amplitude greater than the first amplitude, and as a result, the transmission of the second modulated signal is expected to produce a greater motor response than the transmission of the first modulated signal.Thus, by directly applying a modulated signal to the infrahyoid velvet girdle muscle, it is expected that the ability to regulate tongue movement responses will be enhanced by improving control over evoked patient movement responses and / or the contraction speed of the infrahyoid velvet girdle muscle. By enhancing evoked patient movement responses, airway obstruction can be reduced / prevented and / or patient comfort and / or treatment compliance can be improved.

[0062] In addition, since the infrahyoid velvet girdle muscle is thicker than the nerves and / or nerve branches that innervate them, it is expected that the infrahyoid velvet girdle muscle will be easier to identify (for example, using the ultrasound probe 201 in Figure 2A). Although not bound by theory, the response of the infrahyoid velvet girdle muscle to a directly transmitted modulated signal is expected to have at least low sensitivity to the location of the signal transmitter 100 within the muscle. Therefore, the infrahyoid velvet girdle muscle can define a wide range over which the signal transmitter 100 can be positioned to obtain effective results (for example, compared to nerves), which is expected to reduce the time associated with identifying and / or implanting the signal transmitter 100. In these embodiments and other embodiments, implanting the signaling device 100 to send modulated signals to the infrahyoid genu vein muscle is expected to increase the speed at which the signaling device 100 can be positioned at least near the target location by reducing or eliminating the need to identify a specific branching pattern of the patient's cervical nerve loop and then identify the portion or branch of the cervical nerve loop AC that constitutes the target location.

[0063] Figure 7A is a frontal cross-sectional view of a portion of the patient's neck and mandible, and Figure 7B is a lateral cross-sectional view thereof, showing the signal transmitter 100 implanted between the sternohyoid SHM and the sternothyroid muscle STM in an medial-to-lateral orientation. In this position, the signal transmitter 100 can transmit a modulated signal to one or both of the sternohyoid SHM and the sternothyroid muscle STM. For example, since the sternohyoid SHM and the sternothyroid muscle STM are located close to each other, the electrode 104 can generate an electric field that transmits a modulated signal to both the sternohyoid SHM and the sternothyroid muscle STM simultaneously. In other embodiments, the electrode 104 may be segmented, and each segment carried by the signal transmitter 100 can transmit a modulated signal to one or both of the sternohyoid SHM and the sternothyroid muscle STM.

[0064] The signal transmission device 100 is preferably implanted in this position and orientation using at least substantially the same or identical insertion path as the insertion path 210 described above with reference to Figures 2A to 3B. In other embodiments, the signal transmission device 100 is preferably configured to transmit modulated signals to the sternohyoid muscle SHM, omohyoid muscle OHM, and / or thyrohyoid muscle THM. In some embodiments, the signal transmission device may have another suitable orientation, for example, the downward-upward orientation described above with reference to Figures 5A and 5B.

[0065] Figure 8 is a frontal view of a portion of the patient's neck and mandible, showing the signal transmitter 100 positioned at least partially within the patient's sternothyroid muscle (STM). In this position, the signal transmitter 100 is expected to transmit the modulated signal to (for example, only to) the sternothyroid muscle (STM) without transmitting, or substantially transmitting, the modulated signal to other tissues located outside the sternothyroid muscle (STM). In some embodiments, the signal transmitter may be fully positioned within the sternothyroid muscle (STM), and / or at least partially or fully positioned within one or more of the sternohyoid muscle (SHM), omohyoid muscle (OHM), thyrohyoid muscle (THM), and / or other muscles in the patient's neck and / or mandible.

[0066] Figure 9A is a lateral cross-sectional view of a portion of the anatomical structures of the patient's neck and mandible, the anatomical features including the cervical nerve loop AC, omohyoid muscle OHM, sternohyoid muscle SHM, sternothyroid muscle STM, and thyrohyoid muscle THM. Figure 9A further shows the patient's hypoglossal nerve HGN, such hypoglossal nerve HGN includes the medial branch MB and the anterior branch AB. The anterior branch AB may include the distal branch portion, e.g., the motor site, motor endplate, and / or the neuromuscular junction of the HGN where the HGN enters the mylohyoid muscle GG. In some patients, one or more of the anterior branches AB may include multiple distal brachiated portions DB innervating the patient's mylohyoid muscle GG. By positioning minimally invasive electrodes near the aforementioned nerve structures and / or associated muscles, and activating such positioned minimally invasive electrodes, the effects of OSA can be controlled, reduced, and / or eliminated. Further details relating to the forward branch AB can be found in U.S. Patent Application No. 18 / 393,537, filed on 21 December 2023, which is cited by reference and whose entire contents are incorporated herein by reference.

[0067] Figure 9B is a lateral cross-sectional view of a portion of the patient's neck and mandible, showing the first and second signaling devices 900a and 900b positioned according to various embodiments of the present technology. Each of the first and second signaling devices 900a and 900b is preferably at least substantially the same as or identical to the signaling device 100 described above with reference to Figure 1D in terms of structure and / or function. The first and second signaling devices 900a and 900b may be implanted as part of the same procedure, or one of the first and second signaling devices 900a and 900b may be implanted some time after the other of the first and second signaling devices 900a and 900b has been implanted.

[0068] The first signaling device 900a is preferably positioned to send a modulated signal to a first target tissue, and the second signaling device 900b is preferably positioned to send a modulated signal to a second target tissue different from the first target tissue. For example, in the illustrated embodiment, the first signaling device 900a is positioned to send one or more first modulated signals to the anterior branch AB of the patient's hypoglossal nerve HGN, and the second signaling device 900b is positioned to send one or more second modulated signals to the third branch B3 of the cervical nerve loop AC. In some embodiments, the first signaling device 900a is implanted after the second signaling device 900b, based on the determination that cervical nerve loop AC modulation alone is insufficient to address the patient's respiratory distress. In other embodiments, a second signaling device 900b is implanted after the first signaling device 900a, based on the determination that hypoglossal nerve HGN modulation alone is insufficient to address the patient's respiratory distress.

[0069] The first signaling device 900a and the second signaling device 900b may have other suitable locations. For example, the first signaling device 900a may be positioned to transmit the first modulated signal (directly in the case of the mylohyoid muscle GG) to any one or more of the medial branch MB of the hypoglossal nerve HGN, the mylohyoid muscle GG, the inferior root IR of the cervical loop AC, the superior root SR of the cervical loop AC, one or more branches of the cervical loop AC, one or more motor sites of the cervical loop AC, the omohyoid muscle OHM, the sternohyoid muscle SHM, the sternothyroid muscle STM, the thyrohyoid muscle THM, or any one or more other target locations described herein that engage the patient's OSA. Additionally or alternatively, the second signaling device 900b may be positioned to deliver a second electrical signal (directly in the case of the mylohyoid muscle GG) to one or more of the medial branch MB of the hypoglossal nerve HGM, the anterior branch AB of the hypoglossal nerve HGN, the mylohyoid muscle GG, the inferior root IR of the cervical loop AC, the superior root SR of the cervical loop AC, one or more of the branches of the cervical loop AC, one or more of the motor sites of the cervical loop AC, the omohyoid muscle OHM, the sternohyoid muscle SHM, the sternothyroid muscle STM, and / or the thyrohyoid muscle THM, or any one or more of the other target locations described herein that engage the patient's OSA. In these embodiments and / or other embodiments, the first and second signaling devices 900a, 900b may be positioned to stimulate the left and right tissues of the patient, respectively, for example, the left hypoglossal nerve and the right nerve loop, the left thyrohyoid muscle and the right mylohyoid muscle, etc., bilaterally.

[0070] The first and second transmission devices 900a, 900b are preferably configured to transmit a modulated signal having the same or one or more different signal transmission parameters (e.g., amplitude, frequency, pulse width) to optimize the patient's airflow response or efficacy for each target location, for example. For example, each of the signal transmission parameters may be determined by at least one of the patient's measured airflow response or another physiological input from an external wearable or other device configured to detect the patient's airflow response. Additionally or alternatively, one or more signal transmission parameters of the modulated signals transmitted by the first and second signal transmission devices 900a, 900b may vary by at least one of the locations of the first and second signal transmission devices 900a, 900b and / or target tissue. For example, the first and second signaling devices 900a and 900b are positioned as shown in Figure 9B, and are programmed to transmit modulated signals with different pulse widths. For instance, the first signaling device 900a is responsible for a pulse width of approximately 100 μs, and the second signaling device 900b is responsible for a pulse width of approximately 50 μs.

[0071] In some embodiments, one or more of the signal transmission parameters of the modulated signal transmitted by the first signal transmission device 900a and / or the second signal transmission device 900b may be adjusted or modulated during transmission, for example, in a closed-loop or open-loop manner. For example, adjustment / modulation of the signal transmission parameters can compensate for the movement of one or both of the respective signal transmission devices 900a, 900b relative to the target location after implantation, which may be caused by one or more changes in the patient's movement and / or posture. In addition, adjustment / modulation of the signal transmission parameters can compensate for one or more changes in the patient's sleep stages, data related to the efficacy of the modulation therapy (e.g., airflow, respiratory effort), etc.

[0072] In some embodiments, by activating the first and second signaling devices 900a and 900b separately and independently, one of the first and second signaling devices 900a and 900b may be in an active state, while the other may be in an inactive state. Each of the first and second signaling devices can alternate between active / on and inactive / off states separately and independently for a selected period, for example, a very short duration (e.g., 100 milliseconds) or a longer duration (e.g., 10 seconds). For example, in some embodiments, the on-off modulation pattern may be programmed to periodically alternate between the first signaling device 900a and the second signaling device 900b. For example, the first signaling device 900a may be on (e.g., receiving power and / or transmitting a modulated signal) for a first period (e.g., at least 1 second, at least 2 seconds, at least 3 seconds, at least 4 seconds, at least 5 seconds, etc.), and then the second signaling device 900b may be on for a second period (e.g., at least 1 second, at least 2 seconds, at least 3 seconds, at least 4 seconds, at least 5 seconds, etc.). In some embodiments, the first period and / or the second period may be randomly selected. In some embodiments, the first signaling device 900a may be off (e.g., not receiving power and / or not transmitting a modulated signal) when the second signaling device 900b is on, and the reverse may also be true, and / or the transmission of the modulated signal may be parallel with respect to a portion of the modulation pattern. In other embodiments, both the first signaling device 900a and the second signaling device 900b may be turned on and off simultaneously, or at least approximately simultaneously. In another embodiment, the periods during which a given signaling device 900a, 900b is on or off may be randomized. In some embodiments, after at least one of the first signaling device 900a and the second signaling device 900b has completed an on-time interval, the first signaling device 900a and / or the second signaling device 900b may remain off for an off-time interval.The off-time intervals may be, for example, up to 1 minute, up to 2 minutes, up to 3 minutes, up to 4 minutes, up to 5 minutes, up to 10 minutes, etc. The off-time intervals may also change over time, may be randomly selected, and / or may include one or more other suitable durations.

[0073] In some embodiments, the individual electrodes carried by the first and second signal transmitters 900a, 900b may be activated or deactivated to direct the transmission of the modulation signal towards their respective target presence locations and / or to adjust the electric field generated to transmit the modulation signal (e.g., narrowing or widening the electric field). In the illustrated embodiment, for example, the first and second signal transmitters 900a, 900b each have a quadrupole electrode array 904a, 904b including four electrodes 904a 1~4 ,904b 1~4 . Using the second and third electrodes 904a 2,3 ,904b 2,3 can generate a narrower field than, for example, when using the first and second electrodes 904a 1,4 ,904b 1,4 . In some embodiments, it may be beneficial to activate the second and third electrodes 904a 2,3 of the first signal transmitter 900a, and also to activate the first and second electrodes 904b 1,4 of the second signal transmitter 900b, such that the first signal transmitter 900a generates a relatively narrow field and the second signal transmitter 900b generates a relatively wide field. In other embodiments, any other combination of electrodes 904a 1~4 ,904b 1~4 can be activated.

[0074] In some embodiments, the cycle modulation pattern is preferably programmed to periodically alternate one or more parameters of the signals transmitted by the first and second signal transmitters 900a, 900b. The amplitude, pulse width, and / or frequency are preferably programmed to change randomly, periodically, or at other programmed time intervals in response to the detected data. For example, the first signal transmitter 900a may be set to 1.0 mA per second, then 2.0 mA per second, and then 1.0 mA per second for a modulation duration of 3 seconds. The second signal transmitter 900b may be set to 0.5 mA per second, then 1.0 mA per second, and then 0.5 mA per second for a modulation duration of 3 seconds. In some embodiments, the amplitudes of these patterns can be reversed. The first and second signaling devices 900a and 900b can transmit these modulated signals simultaneously or at different times, and / or transmit the modulated signals in parallel for a portion of the modulation pattern.

[0075] In some embodiments, the if-then modulation pattern may be programmed to respond to one or more specific physiological measurements (e.g., airflow) detected or calculated by, for example, one or more sensors of a signaling device, one or more sensors implanted in the patient's body, and / or a wearable or other external detection device. For example, one of the first and second signaling devices 900a, 900b may be turned on by a wearable. If the patient's physiological response is insufficient when determined based on at least one or more physiological measurements, the other of the first and second signaling devices 900a, 900b may be turned on, resulting in both the first and second signaling devices 900a and 900b operating simultaneously. Additionally or alternatively, one or more parameters of each signal transmitted by the first and second signaling devices 900a, 900b may be adjusted in response to one or more physiological measurements (e.g., as described herein).

[0076] In some embodiments, the first and second signal transmitters 900a and 900b are programmed with phase manipulation patterns. For example, the amplitude of the modulated signal transmitted by the first signal transmitter 900a can rise and fall in a sinusoidal shape during the modulation time interval. The modulated signal transmitted by the second signal transmitter 900b is preferably a similar amplitude shape and has a fading pattern that is in phase with or 180° out of phase with the modulated signal of the first signal transmitter. In at least some embodiments, the first and / or second signal transmitters 900a and 900b are preferably programmed to cause phase inversion by transmitting their respective modulated signals. In some embodiments, the modulated signal is preferably a square wave and changes in steps, for example, with a gradient from the first pulse to the second pulse.

[0077] 4. Typical experimental data Figure 10A shows a plot of patient data obtained by directing a modulated signal to the patient's cervical nerve trap according to several embodiments of the present technology. Figure 10A includes plots of respiratory impedance plethysmography (volume change recording) ("RIP") 1020, CPAP mask pressure 1022, airflow rate 1024, and the cervical nerve trap modulated signal 1026 during multiple signaling periods 1028 (individually, a first signaling period 1028a, a second signaling period 1028b, and a third signaling period 1028c) and post-signaling period 1029.

[0078] To obtain this data, patients were fitted with an electroencephalograph, electrooculograph, submental electromyograph, epiglottic pressure sensor, and a sealed nasal mask / respiratory flowmeter to quantify airflow. Following propofol sedation, ultrasound was used to identify the patient's cervical nerve loop and guide the placement of the transcutaneous electrode array in at least substantially the same position and / or orientation as in the embodiment shown in Figure 6D, as described above herein. The electrode array used in this study consisted of four electrodes arranged in series (hereinafter referred to as electrode #1, electrode #2, electrode #3, and electrode #4). An endoscope was inserted through the patient's nose to visualize changes in the dimensions and shape of the patient's airway during the period in which modulated signals were sent through the electrode array to the distal branches. A modified CPAP device was used to administer therapeutic CPAP / temporary pressure reduction and induce airflow limiting / obstruction in a manner that simulated respiratory distress experienced by patients with respiratory sleep disturbances.

[0079] During the post-signal transmission period 1029, the pressure in the patient's airway returned to normal levels, as indicated by the changes in the RIP and CPAP mask pressure plots 1020 and 1022, and the electrode array was inactive (i.e., no modulated signal was delivered to the patient's cervical nerve trap). Outside of the signal transmission period 1028, the decrease in the RIP plot 1020, CPAP mask pressure plot 1022, and airflow plot 1024 relative to the post-signal transmission period 1029 indicates that the patient's breathing was obstructed (occluded).

[0080] During each of the signal transmission periods 1028, the modulated signal was directed from the electrode array positioned according to the embodiments of the present technology to the cervical nerve trap. Specifically, during the first signal transmission period 1028a, a 1 mA bipolar modulated signal was transmitted to the cervical nerve trap with electrode #1 acting as the cathode and electrode #3 acting as the anode. The 1 mA modulated signal did not substantially increase or improve the patient's airflow before, during, and after the first signal transmission period 1028a, as shown by the patient airflow plot 1024. This is further supported by the fact that the RIP plot 1020 and the CPAP mask pressure plot 1022 remained substantially unchanged during the first signal transmission period 1028a.

[0081] During the second signal transmission period 1028b, a 1.5 mA bipolar modulated signal was delivered to the cervical nerve trap with electrode #1 acting as the cathode and electrode #3 acting as the anode. The 1.5 mA modulated signal increased the patient's airflow, as indicated by the corresponding change in the airflow plot 1024 during the second signal transmission period 1028b, but this change did not fully restore the patient's airflow. In other words, the 1.5 mA signal produced a beneficial but insufficient flow response. This change in the patient's airflow is further demonstrated by the corresponding changes in the RIP and CPAP mask pressure plots 1020,1022 during the second signal transmission period 1028b.

[0082] During the third signal delivery period 1028c, a 2mA modulated signal was delivered to the cervical nerve trap with electrode #1 acting as the cathode and electrode #3 acting as the anode. The 2mA modulated signal increased the patient's airflow, as shown in the corresponding plot of airflow plot 1024 during the third signal delivery period 1028c. Compared to the 1.5mA delivered during the second signal delivery period 1028b, the 2mA modulated signal resulted in a significant increase in the patient's airflow, completely restoring the patient's airflow to normal or pre-occlusion levels. This change in airflow is further demonstrated by the corresponding changes in RIP and CPAP mask pressure plots 1020,1022 during the third signal delivery period 1028c.

[0083] During the fourth signal transmission period 1028d, a 0.5mA modulated signal was delivered to the cervical nerve trap with electrode #2 acting as the cathode and electrode #4 acting as the anode. The 0.5mA transmission signal did not substantially increase or improve the patient's airflow, as shown by the patient airflow plot 1024 before, during, and after the fourth signal transmission period 1028d. This is further supported by the fact that the RIP 1020 and CPAP mask pressure plot 1022 remained substantially unchanged during the fourth signal transmission period 1028d.

[0084] During the fifth signal delivery period 1028e, a 1.5 mA bipolar modulated signal was delivered to the cervical nerve trap with electrode #2 acting as the cathode and electrode #4 acting as the anode. The 1.5 mA modulated signal increased the patient's airflow, as indicated by the corresponding change in the airflow plot 1024 during the fifth signal delivery period 1028e, but this change did not fully restore the patient's airflow. In other words, the 1.5 mA modulated signal produced a beneficial but submaximal flow response. This change in the patient's airflow is further demonstrated by the corresponding changes in the RIP and CPAP mask pressure plots 1020,1022 during the fifth signal delivery period 1028e. However, the increase in airflow during the fifth signal delivery period 1028e was approximately equal to the increase in airflow that occurred during the second signal delivery period 1028b in response to another 1.5 mA modulated signal.

[0085] During the sixth signal transmission period 1028f, a 2mA bipolar modulated signal was transmitted to the cervical nerve trap with electrode #2 acting as the cathode and electrode #4 acting as the anode. The 2mA modulated signals transmitted by electrodes #1 and #3 during the third signal transmission period 1028c fully restored the patient's airflow, but the 2mA modulated signals transmitted by electrodes #2 and #4 during the sixth signal transmission period 1028f increased the patient's airflow to a level below full (see the corresponding change in airflow plot 1024 during the sixth signal transmission period 1028f for this). In other words, the 2mA signals transmitted by electrodes #2 and #4 during the sixth signal transmission period 1028f were beneficial, but resulted in a below-maximum flow response. This change in patient airflow is further demonstrated by the corresponding changes in RIP and CPAP mask pressure plots 1020,1022 during the sixth signal transmission period 1028f. Therefore, given a specific position of the electrode array relative to the cervical nerve loop, superior results can be obtained by selecting one or more combinations of hyperbolic electrode array states (for example, at this particular position of the electrode array, using electrode #1 as the cathode and electrode #3 as the anode is a better primary configuration than using electrode #2 as the cathode and electrode #4 as the anode).

[0086] During the post-signal transmission period 1029, the pressure in the patient's airway returned to normal levels, as indicated by the changes in the RIP and CPAP mask pressure plots 1020, 1022, and the electrode array was inactive (i.e., no modulated signal was delivered to the patient's cervical nerve trap). Therefore, the airflow plot 1024 during the post-signal transmission period 1029 represents the patient's normal respiratory behavior. By comparing the airflow plot 1024 during the third transmission period 1028c and the post-signal transmission period 1029, it is further shown that the 2mA modulated signal delivered during the third signal transmission period 1028c fully restored the patient's airflow.

[0087] These data demonstrate that, by transmitting modulated signals from an electrode array positioned according to embodiments of the present technology to the cervical nerve trap, the patient's motor response (e.g., caudal traction force) restored airflow. In addition, although the patient was sedated during this test, the inventors observed data indicating that, for example, if the modulated signals transmitted during signal transmission period 1028 were transmitted to the patient while the patient was asleep, it is uncertain whether the patient woke from sleep. Some of the amplitudes used during signal transmission period 1028 were lower than the amplitudes (e.g., approximately 2 mA to approximately 4 mA amplitude or magnitude) used to stimulate the hypoglossal nerve and produce an increase in the patient's airflow response as described with reference to at least Figures 12-15 of, for example, U.S. Patent Application No. 18 / 393,537 (this U.S. Patent Application is cited by reference, and its entirety is part of this specification). Therefore, although not bound by theory, the relatively low amplitude of the signal transmitted to the cervical nerve trap is compared to the transmission requirements for one or more implanted devices positioned to transmit a modulated signal to the hypoglossal nerve. It is expected that the amount of power delivered to one or more implanted devices positioned to deliver modulated signals to the cervical nerve loop will be reduced. In some embodiments, the low amplitude associated with the cervical nerve loop is expected to reduce the amount of power delivered to one or more implanted devices positioned to deliver modulated signals to the cervical nerve loop compared to the power delivery requirements for one or more implanted devices positioned to deliver modulated signals to the hypoglossal nerve. However, in these embodiments and / or other embodiments, using hypoglossal nerve modulation as a secondary modulation site and / or in addition to the cervical nerve loop is expected to improve (e.g., further improve) the patient's airflow.

[0088] Figure 10B is a table containing data obtained by positioning and activating the signaling device according to various embodiments of the present technology. The signaling device is positioned to stimulate the cervical nerve loops of subjects 1, 4, and 5 using a medial-to-lateral approach, as described above herein with reference to Figure 2A. The signaling device is also positioned to stimulate the cervical nerve loops of subjects 2, 3, 5, 6, and 7 using a lateral-to-medial approach, as described above herein with reference to Figure 2A. As indicated by the VOTE ("Velum Oropharynx Tongue Epiglottis") score in this table, subjects 1-7 were positioned at various locations (e.g., cheek / posterior palate, oropharynx, base of tongue / posterior lingual, and / or epiglottis / posterior epiglottis) and documented various types of tissue collapse (e.g., anterior-posterior A / P, concentric, or lateral-lateral (L / L)) both before and after modulation. Despite the differences in how these subjects' respiratory distress manifested physiologically, modulated signals of varying amplitudes (e.g., ranging from approximately 0.5 mA to 5 mA) were transmitted, resulting in at least an 80% increase in peak airflow amplitude, with the majority of subjects showing an increase of over 100% in peak airflow amplitude. In addition, subjects 2–4 experienced tongue base collapse, which has traditionally been addressed by stimulating the hypoglossal nerve. However, modulating the cervical nerve loops of subjects 2–4 according to embodiments of this technique significantly increased their airflow. Modulating the cervical nerve loops in the manner performed on subjects 2–4 surprisingly caused the base of their tongues to move downward, thereby reducing tongue base collapse and strengthening the airway through caudal traction. As a result, a remarkably large increase in airflow was obtained in subjects 2–4. This was all the more surprising, because, as described above herein with reference to Figure 1A, the inventors observed that by modulating the cervical nerve loop to generate a caudal traction force, the hyoid bone is lowered, causing a corresponding movement of the base of the tongue, and that such movement can reduce or even eliminate tongue base collapse in at least some cases.

[0089] Figure 10C is a plot showing the recovery of airflow for all subjects listed in the table in Figure 10B, with the exception of subject 5. As shown in the figure, the various modulation signals described above significantly improved the airflow of the subjects. Most subjects showed airflow levels associated with respiratory depression before and after modulation, but during modulation, the airflow levels of these subjects increased to the range associated with snoring. Subjects 2 and 3 showed an increase in airflow levels to a level associated with no respiratory impairment at all. Subject 7's airflow increased from a level associated with complete apnea (e.g., airflow from near-no apnea to near-no apnea) before modulation to a level associated with snoring during modulation. The inventors did not expect that sending the modulation signal only to the cervical nerve loop would increase the airflow portion of this amplitude.

[0090] The data in Figures 10A–10C demonstrate that the patient's motor response (e.g., caudal traction) restored airflow by transmitting a modulated signal from an electrode array positioned according to embodiments of the present technology to the cervical nerve trap. In addition, no signs of patient arousal were observed during the signal transmission period 1028. Some of the amplitudes used during the signal transmission period 1028 were lower than the amplitudes (e.g., approximately 2 mA–4 mA) used to stimulate the hypoglossal nerve and produce the corresponding increase in patient airflow described with reference to at least Figures 12–15 of, for example, U.S. Patent Application No. 18 / 393,537 (this U.S. Patent Application is cited by reference, and its entirety is part of this specification). Therefore, although not theoretical, it is expected that relatively low amplitudes of signals transmitted to the cervical nerve trap will reduce or completely eliminate the patient's arousal rate, while further increasing or even completely restoring the patient's airflow to address respiratory distress. In some embodiments, the low amplitude associated with cervical nerve trap modulation is expected to reduce the amount of power delivered to one or more implanted devices positioned to deliver the modulated signal to the cervical nerve trap, compared to the power delivery requirements for one or more implanted devices positioned to deliver the modulated signal to the hypoglossal nerve. However, in these embodiments and / or other embodiments, using hypoglossal nerve modulation as a secondary modulation site and / or in addition to the cervical nerve trap is expected to improve (e.g., further improve) the patient's airflow.

[0091] While certain modulation amplitudes have been described above with reference to Figures 10A and 10B, in other embodiments, additional and / or other modulation amplitudes may be delivered to the cervical nerve loop, hypoglossal nerve, and / or one or more other target tissues described herein. In some embodiments, the modulation amplitudes may be based on at least one modulation threshold associated with the corresponding target tissue. Generally, with respect to a given nerve, the modulation threshold is the modulation level (e.g., amplitude) above which any further increase in the modulation level does not produce an increase in the patient's airflow response. This is because modulation at the modulation threshold produces a total muscle response (e.g., total contraction and / or tetany response of one or more muscles innervated by the cervical nerve loop), and therefore, modulation at a level higher than the modulation threshold cannot produce any further muscle response beyond the already total muscle response.

[0092] As shown in Figure 10A, increasing the amplitude of the modulated signal from 1.5 mA during the second signal transmission period 1028b to 2 mA during the second signal transmission period 1028c resulted in a corresponding increase in the patient's airflow. Therefore, since increasing the amplitude beyond 1.5 mA resulted in an increase in the patient's airflow, the cervical nerve trap is expected to have a modulation threshold greater than 1.5 mA. In other words, a 1.5 mA modulated signal is a subthreshold signal lower than the modulation threshold. The modulation threshold for this patient and / or other patients may vary based on at least one of the proximity of the electrode array to the cervical nerve trap and / or the placement of the electrode array along the cervical nerve trap. Sending one or more modulated signals to the cervical nerve trap with amplitudes below the threshold is not expected to produce a full muscle response (e.g., full contraction and / or tetany response of one or more muscles innervated by the cervical nerve trap). In contrast, sending a modulated signal to the cervical nerve trap with an amplitude below the threshold is expected to strengthen or tighten one or more of the muscles innervated by the cervical nerve trap and improve airflow, thereby reducing the risk of these tissues obstructing the patient's respiration and / or at least reducing the risk of further obstruction of the patient's respiration without causing total muscle contraction or a tetany response.

[0093] From some perspectives of this technology, subthreshold amplitudes can restore one or more tissues in a patient's airway to a more neutral state (e.g., muscle tone closely resembling that of a healthy patient's tissue), and / or, such subthreshold amplitudes allow the patient to breathe more naturally compared to threshold or threshold hypermodulation amplitudes. For example, as mentioned above, threshold or threshold hypermodulation amplitudes are expected to cause full contraction of muscles innervated by the cervical nerve loop. The resulting sensory experience for the patient is often unpleasant and quite different from natural breathing, and this can lead to arousal. Furthermore, full muscle contraction is not necessary to adequately improve the patient's airflow or to adequately address the patient's respiratory distress in a different way. The one or more muscles that contract in response to modulation should also be selected to allow the patient to breathe more naturally during modulation. For example, most patients are accustomed to the experience of their sternothyroid and / or sternohyoid muscles contracting maximally during breathing (e.g., during yawning). However, most patients are unfamiliar with the experience of their mylohyoid muscle GG being maximally contracted, because this does not occur regularly during inspiration. Therefore, it is expected that sending a modulated signal that causes the sternohyoid muscle SHM and / or sternothyroid muscle STM to contract is less likely to awaken the patient from sleep and / or cause discomfort in a different way than a modulated signal that causes the mylohyoid muscle to contract.

[0094] By strengthening the tissues constituting the patient's airway without causing full muscle contraction, it is possible to improve the patient's respiration without causing discomfort (e.g., arousal), or with minimal discomfort. For example, as shown in Figure 10A, a subthreshold 1.5 mA modulated signal delivered during the second signal delivery period 1028b improved the patient's airflow. While this 1.5 mA modulated signal did not fully restore the patient's airflow, it has the advantage of delivering the modulated signal at a subthreshold amplitude. For example, at least some subthreshold amplitudes are lower than the patient's perceptual threshold and / or arousal threshold. The perceptual threshold is the modulation level (e.g., amplitude) at which the patient perceives or detects (e.g., while awake or conscious) that they are receiving a modulated signal. This is because, in many cases, the patient can perceive or detect the muscle or motor response produced by the modulated signal. The arousal threshold is the modulation level (e.g., amplitude) at which the patient becomes awake or wakes from sleep. This means that amplitudes below the threshold are less likely to cause discomfort or awaken the patient from sleep, and therefore these amplitudes are more comfortable than those at or above the threshold.

[0095] Modulation response data, such as the data shown in Figures 10A and 10B, can be used to customize treatment methods for a given patient. For example, at least some embodiments of this technique include the steps of calculating the patient's perceptual threshold and / or arousal threshold, and delivering one or more modulated signals at one or more levels (e.g., amplitude) lower than the perceptual threshold and / or arousal threshold. In the step of calculating the patient's perceptual threshold, it is preferable to deliver the modulated signals at multiple (e.g., increasing) amplitudes and ask the patient which of the modulated signals they perceived. To calculate the patient's arousal threshold, it is preferable to deliver the modulated signals at multiple (e.g., increasing) amplitudes while the patient is asleep to determine which amplitudes will wake the patient. Most patients are tolerant to high levels of modulation during sleep (and in many cases, they do not consciously perceive this modulation because they are asleep). Therefore, most patients have (or are expected to have) a higher arousal threshold than their perceptual threshold. In some embodiments, it is preferable to calculate the patient's response or quantify it in relation to the transmitted modulated signal. For example, to calculate the patient's response, it is preferable to calculate the patient's AHI and / or generate a dose-response curve plotting the AHI against the modulated signal. Using the calculated patient responses to multiple modulated signals, it is possible to identify which modulated signal level resulted in a moderate or optimal patient response. For example, using the calculated patient responses to modulated signals, it is possible to determine which modulated signal resulted in a moderate improvement in airflow or other respiratory activity while reducing or minimizing patient discomfort. In at least some embodiments, the transmitted subthreshold modulated signal may have an amplitude of up to 1%, 5%, 10%, 15%, 20%, 25%, 30%, 40%, 50%, 60%, 70%, 75%, 80%, 90%, or 99% of the perceptual and / or arousal threshold.Delivering one or more modulated signals at a subthreshold level can stiffen and / or move one or more tissues constituting the patient's airway, and improve the patient's respiration without causing total muscle contraction and without, or substantially without, the discomfort (e.g., arousal) described herein. In some embodiments, the step of delivering one or more modulated signals at a subthreshold level includes the step of delivering one or more modulated signals calculated using the dose-response curve described above.

[0096] In some embodiments, the technique includes the step of selecting an electrode pair to deliver one or more modulated signals based on at least one modulated response data from a patient. The step of selecting an electrode pair may include the steps of delivering one or more modulated signals with different combinations of electrodes, and determining the electrode pair that produces the best or optimal result. For example, as shown in Figure 10A, the patient responded better to a first 2mA modulated signal delivered by electrodes #1 and #3 during a third signal delivery period 1028c than to a second 2mA modulated signal delivered by electrodes #2 and #4 during a sixth signal delivery period 1028f. Therefore, electrodes #1 and #3 may be selected for use during subsequent trials and / or chronic use.

[0097] While the concept of subthreshold modulation has been described above in relation to amplitude, in these embodiments and / or other embodiments, subthreshold modulation can be provided by adjusting other modulation parameters. In at least some embodiments, for example, adjusting the pulse width of the modulation delivered to the patient can provide subthreshold modulation in addition to or instead of adjusting the amplitude. If the modulated signal delivered to the patient is equal to or exceeds the modulation and / or perceptual threshold for that patient, it is good to increase the pulse width of the modulated signal and / or decrease the amplitude of the modulated signal so that, for example, the modulated signal becomes lower than the modulation and / or perceptual threshold. Amplitude, pulse width, and / or one or more other modulation parameters (e.g., frequency, duty cycle, interval between pulses, etc.) can be adjusted manually (e.g., by the user) or automatically.

[0098] 5. Additional devices, systems, and methods Figure 11 is a block diagram showing the elements of a system 1130 for treating sleep disorders according to various embodiments of the present technology. The system 1130 may include a wearable device 1132, a charger 1134, one or more implants or signaling devices (e.g., a first signaling device 1100a, a second signaling device 1100b...nth signaling device 1700n, collectively referred to as "signaling device 1100") and a connection device or programmer 1136. Generally, the programmer 1136 may send commands to the wearable device 1132 to generate modulated signals (e.g., signal transmission or waveform parameters), the wearable device 1132 may send these commands and power to the signaling devices 1100, one or more of the signaling devices 1100 may generate modulated signals according to the commands sent, and apply these modulated signals to the patient via electrodes supported by the signaling devices 1100. The individual signal transmitters 1100 should be at least substantially or completely identical in structure and function to the signal transmitter 100 shown in Figure 1D. In addition, one or more signal transmitters 1100 should be implanted in the patient's body using one or more of the insertion routes described above with reference to Figures 2A to 9B, and in one or more of the positions and / or orientations described above with reference to Figures 2A to 9B, and / or to transmit modulated signals to one or more parts of the cervical nerve loop, one or more of the infrahyoid girdle, and / or one or more other target tissues described above with reference to Figures 2A to 9B.

[0099] The programmer 1136 may include a programmer operated by the patient and / or a programmer operated by a clinician, such programmer may be configured to control one or more characteristics of the modulated signal sent to the patient. In a typical embodiment, the programmer 1136 may include a therapeutic adjustment module configured to select individual electrodes supported by the signaling device 1100 and adjust (e.g., increase or decrease) amplitude, frequency, pulse width, burst duration, and / or any other appropriate signaling parameters, whether the electrodes are active or inactive. In addition, the programmer 1136 may synthesize information received from the user, the wearable 1132, and / or the signaling device 1100 (e.g., diagnostic and / or feedback information), and adjust one or more of the signaling parameters based on at least partially synthesized information. For example, the programmer 1136 may receive one or more inputs corresponding to the patient's thresholds and / or arousal thresholds, and adjust the amplitude of the modulated signal sent to the patient based on at least one of the patient's perceptual thresholds and / or arousal thresholds. Additionally or alternatively, programmer 1126 may generate a dose-response curve plotting the AHI against the modulation amplitude, as described above herein, and use the dose-response curve to adjust or provide recommended adjustments for the amplitude of the modulation signal delivered to the patient.

[0100] The programmer 1136 can send signal transmission parameters directly and / or via the wearable device 1132 to the signal transmission device 1100. For example, the programmer 1136 may be connected to the signal transmission device 1100 and / or the wearable device 1132 via a wired or wireless communication link, such as Wi-Fi, Bluetooth ("BT"), cellular connectivity, and / or any other suitable communication link. In these and other embodiments, the programmer 1136 may be connected to the cloud 1962 and / or other computer services to upload and / or download data received from the sensors of the wearable device 1132 to the information wearable device 1132 and / or the signal transmission device 1100. In these and other embodiments, the programmer 1136 may include a display and / or a user interface. A user (for example, a patient, a clinician, and / or other appropriate user) can interact with and / or control one or more viewpoints of the programmer 1136 via the user interface, for example, by manually adjusting one or more of the signal transmission parameters, reading data received from the sensors of the wearable device 1132 to provide one or more inputs corresponding to tissue collapse patterns, and / or to perform other tasks.

[0101] The wearable device 1132 may include a collar, chin strap, mouthpiece, and / or pillow, and / or have other suitable form factors. The wearable device 1132 may have one or more sensors (e.g., a single sensor, an array of sensors, and / or other suitable sensor arrays) configured to collect patient-related data. Typical data to be received from the patient include, among other things, respiratory rate, sleep state, wakefulness state, heart rate, acoustic signals (audible snoring, respiratory depression events, and / or apnea events), body temperature, head orientation / position, blood oxygen saturation, airflow level, thyroid movement, tracheal movement, and / or tongue movement, and photoplethysmography (PPG) data, each of which may be received by a corresponding form of sensor (e.g., heart rate data from a heart rate sensor, head orientation / position data from an accelerometer, etc.). These data are preferably received by one or more corresponding sensors (e.g., body temperature from a temperature sensor, audio signals from a microphone or other audio signal), and such data preferably correspond to the patient's respiratory performance, sleep state, wakefulness state, and / or other appropriate metrics, such as measures of metrics used to rate the patient by apnea-hypopnea index (AHI). Additionally or alternatively, the wearable 1132 may receive data from individual signaling devices 1100 using, for example, backscattering techniques, pulse width modulation techniques, frequency modulation techniques, and / or one or more other appropriate techniques. For example, the signaling device 1100 may send an acceptance to indicate that power has been received and what the amplitude of the power is. This information can be used to self-adjust (up or down) the output of the pulse generator of the signaling device, for example, the transmitted signal and phase.

[0102] The wearable device may further include a power source (e.g., a power storage device, e.g., a battery), a power transmission component configured to send power and / or signal transmission parameters to the implantable device 1100, and one or more algorithms configured to control one or more aspects of the operation of the wearable device 1132. Individual sensors may collect patient-related data, e.g., the patient's sleep state and / or respiratory performance. One or more algorithms may be configured to adjust at least one of the signal transmission parameters based at least partially on data collected by the sensors. In a typical embodiment, the wearable device 1132 may have an integrated sleep, respiratory diagnostic, and / or therapeutic adjustment system configured to adjust or otherwise control one or more transmission parameters of a modulated signal sent to the patient based on collected respiratory state and / or respiratory performance data by one or more algorithms.

[0103] In some embodiments, the wearable device 1132 may further have a cover or housing, at least a portion of which may be removable to expose, for example, the interior or inner portion of the wearable device 1132. In these embodiments and other embodiments, the cover of the wearable device 1132 may include fabric or any other suitable material. Optionally, the wearable device 1132 may have a simplified and / or simplified user interface configured to allow a user to interact with and / or control one or more elements of the wearable device 1132 in a different way (for example, checking the charge status of the power supply and adjusting one or more signal transmission parameters) without using, for example, the programmer 1136. For example, the wearable device user interface allows the user to check the power charge status, power on and / or power off the wearable device 1132, adjust one or more signal transmission parameters, configure and / or verify treatment transmission, select one or more treatment presets, and confirm and / or verify the placement of the wearable device.

[0104] The charger 1134 for the wearable device 1132 is preferably configured to supply power to the power source of the wearable device 1132. Examples of charger 1134 include wireless (e.g., inductive) chargers, wired chargers (e.g., wall-plug type charging cables), and / or any other suitable charger or charging device. Optionally, the charger 1134 may have an integrated controller and / or a connected device to control the charging of the wearable device 1132 and / or to upload / download data to / from the wearable device 1132 while the wearable device 1132 is charging.

[0105] One or more of the signal transmitting devices 1100 may include an RFID component (e.g., an unambiguous RFID tag that can be used to identify and / or locate the associated signal transmitting devices 1100a-1100n), a power receiving device (e.g., one or more RF power antennas, one or more inductive coils, etc.), a forward converter / DC-DC converter, a circuit component (e.g., one or more application-specific integrated circuits (ASICs), state machines, etc.), a signal generator, and two or more electrodes, each individually selectable to send a modulated signal to the patient. The power receiving device may receive power from the power transmitting component of the wearable device (e.g., one or more RF power antennas, one or more inductive coils, etc.). The forward converter / DC-DC converter may be operationally coupled to the electrode receiving antennas and configured to send the received power to the signal generator. In addition, each of the signal transmitters 1100 may receive information via a power receiving device and / or one or more other communication components regarding one or more transmission parameters of a modulated signal that is to be generated by a signal generator and / or sent to the patient via at least one of the electrodes of the signal transmitter 1100. The circuit section may store machine-readable instructions related to the operation of the signal transmitters 1100. For example, the circuit section may store instructions that, when executed, cause the signal generator to generate a modulated signal including the transmission parameters received via the electrode receiving antenna. In these embodiments and other embodiments, the power receiving device and / or one or more other communication components can be used to send information related to the signal transmitter 1100 to the wearable device 1132. For example, the signal transmitter 1100 may be used to send information related to one or more transmission parameters of a modulated signal being applied to the patient to the wearable device 1132. In these embodiments and other embodiments, each of the one or more signaling devices 1100 may have an airtight package or housing configured to allow the signaling device 1100 to be implanted in the patient's body.

[0106] In some embodiments, one or more of the signaling devices 1100 are passive devices that do not include an onboard pulse generator configured to generate a modulated signal. In contrast, the passive signaling devices can wirelessly receive a power signal from the wearable device 1132 and transmit the received power signal to the wearer via electrodes. The passive signaling devices can modulate or process the received power signal in a different way, but they do not use the received power signal to power an onboard pulse generator.

[0107] Figure 12 is a partial schematic side view showing another signaling device 1200 configured according to embodiments of the present technology. The dimensions shown in Figure 12 are for illustrative purposes only, and in at least some embodiments, all or one or more parts of the signaling device 1200 may have dimensions other than those shown in Figure 12. In at least some embodiments, the signaling device 1200 is preferably at least substantially the same as or identical to the signaling device 100 of Figure 1D in structure and / or function. For example, the illustrated signaling device 1200 has 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 unipolar electrode array or a bipolar (or other multipolar) electrode array. In some embodiments, the electrode array 1204 may include electrodes made of PT and / or IR, Pt90 / Ir10, and / or one or more other suitable materials. The housing 1202 is preferably configured to hermetically house one or more circuit components of the signaling device 1200, such as a signal generator 1206 and / or an antenna 1208. All or part of the housing 1202 is preferably made of PT, PtIr, Ti6AL4V, epoxy, TPE, one or more ceramics, and / or one or more other suitable materials. For example, the portion of the housing 1202 surrounding the antenna 1208 is preferably made of epoxy, ceramic, TPE, and / or one or more other materials configured to prevent, or at least partially prevent, interference with the power transmission to the antenna 1208. Optionally, all or part or at least part of the housing 1202 is preferably electrically activatable and also configured to function as an electrode, for example, if the electrode array 1204 is unipolar.

[0108] In addition, the signal transmission device 1200 has a lead portion 1203 that is coupled to the housing 1202 and carries the electrode array 1204. The lead portion 1203 is preferably flexible in whole and / or configured to undergo elastic deformation. In some embodiments, the lead portion 1203 is detachable from the housing 1202 and is configured to be coupled to and / or docked with the housing 1202, for example in vivo. In some embodiments, the lead portion 1203 is preferably made of one or more thermoplastic polyurethanes (TPUs), such as Tecothane®, and / or one or more other suitable materials. The lead portion 1203 is preferably made of one or more wires and / or conductive elements that electrically couple the electrode array 1204 to the signal generator 1206. The wires / conductive elements are preferably made of MP35N and / or one or more other suitable conductive materials.

[0109] Therefore, in some respects of this technology, one or more signaling devices can be implanted in a patient's body to deliver one or more modulated signals to the patient's cervical nerve loop and / or one or more muscles innervated by the cervical nerve loop. By delivering modulated signals to the cervical nerve loop, a caudal traction effect can be produced, or at least one or more tissues constituting the patient's airway can be strengthened, thereby improving the patient's airflow and / or addressing respiratory distress in a different way. Cervical nerve loop modulation itself is expected to address respiratory distress in many patients. Improving the patient's airflow by modulating the cervical nerve loop can be achieved with lower amplitudes compared to other target tissues (e.g., one or more of the hypoglossal nerve, infrahyoid genu girdle muscles, etc.), and therefore this method is expected to address respiratory distress with a lower level of patient arousal and / or reduced power delivery requirements. Patients for whom cervical nerve loop modulation is insufficient to adequately improve airflow can, for example, accept another signaling device implanted in the patient's hypoglossal nerve to modulate the hypoglossal nerve as needed to improve the patient's airflow. Similarly, patients for whom hypoglossal nerve modulation is insufficient to adequately improve airflow can, for example, accept another signaling device implanted to deliver modulating signals to the patient's cervical nerve loop to modulate the cervical nerve loop as needed to improve the patient's airflow.

[0110] 6. Embodiment The following embodiment section provides another embodiment of the technology. [Implementation item 1] A method for addressing sleep apnea in patients, the above method is The step of percutaneously inserting the implantable signaling device at the insertion site on the patient's neck, The above signal transmission device is moved in the direction from the inside to the outside towards the cervical nerve loop of the patient. A method comprising the step of implanting the signal transmitting device at a target location at least near the cervical nerve loop, wherein the signal transmitting device has at least one electrode positioned to transmit a modulated signal to tissue located at least near the target location. [Implementation Section 2] The method according to Embodiment 1, characterized in that the step of moving the signal transmitting device in the direction from the inside to the outside includes the step of moving the signal transmitting device from the patient's midsagittal surface at an angle of about 20° to about 80° with respect to the midsagittal plane. [Embodiment 3] The method according to Embodiment 2, characterized in that the above angle is approximately 45° to approximately 80°. [Embodiment Item 4] The method according to embodiment 3, characterized in that the above angle is approximately 60° to approximately 80°. [Embodiment 5] The method according to any one of embodiments 1 to 4, characterized in that the step of implanting the signal transmitting device includes implanting the signal transmitting device at least near the superior branch of the cervical nerve loop in the patient. [Implementation Section 6] The method according to any one of embodiments 1 to 4, characterized in that the step of implanting the signal transmitting device includes implanting the signal transmitting device at least near the lower branch of the nerve trap in the patient. [Embodiment 7] The method according to any one of embodiments 1 to 4, characterized in that the step of implanting the signal transmitting device includes implanting the signal transmitting device at least near a branch of the cervical nerve loop that innervates the omohyoid muscle of the patient. [Embodiment 8] The method according to any one of embodiments 1 to 4, characterized in that the step of implanting the signal transmitting device is performed by implanting the signal transmitting device at least near a branch of the cervical nerve loop that innervates the sternohyoid muscle of the patient. [Embodiment Item 9] The method according to any one of embodiments 1 to 4, characterized in that the step of implanting the signal transmitting device includes implanting the signal transmitting device at least near a branch of the cervical nerve loop that innervates the sternothyroid muscle of the patient. [Implementation item 10] The method according to any one of embodiments 1 to 4, characterized in that the step of implanting the signal transmitting device includes implanting the signaling device at least near a branch of the cervical nerve loop that innervates both the patient's sternohyoid muscle and the patient's sternothyroid muscle. [Initiative 11] The method according to any one of embodiments 1 to 4, characterized in that the step of implanting the signal transmitting device includes implanting the signal transmitting device at least in close proximity to the distal end of the branch of the cervical nerve loop and transmitting the modulated signal to the motor site of the branch that innervates one of the patient's sternohyoid muscle, the patient's sternothyroid muscle, or the patient's omohyoid muscle. [Implementation item 12] The method according to any one of embodiments 1 to 4, characterized in that the step of implanting the signal transmitting device at least near the target location includes the step of implanting the signal transmitting device at least near the patient's thoracic muscle. [Embodiment 13] The method according to embodiment 12, characterized in that the step of implanting the signal transmitting device near at least the sternohyoid muscle, sternohyoid muscle, omohyoid muscle and / or thyrohyoid muscle of the patient is further characterized in that the step of implanting the signal transmitting device near at least the sternothyroid muscle, sternohyoid muscle, omohyoid muscle and / or thyrohyoid muscle of the patient. [Embodiment Item 14] The method according to any one of embodiments 1 to 13, further comprising the step of sending the above-mentioned modulated signal to the target tissue to increase the stability of at least a portion of the patient's airway, wherein the increase in stability includes at least one of (i) increasing the stiffness of at least a portion of the pharyngeal wall of the patient's airway, (ii) increasing the dimensions of the patient's posterior palatine airway, and (iii) decreasing the resistance to airflow through the at least portion of the airway. [Embodiment Item 15] The method according to any one of embodiments 1 to 14, further comprising the step of sending the above signal to the target tissue and causing a caudal traction effect by lowering one or both of the patient's hyoid bone and / or thyroid cartilage. [Implementation Item 16] The method according to any one of embodiments 1 to 15, characterized in that the step of inserting the signal transmitting device percutaneously includes the step of moving the signal transmitting device in a forward-to-backward direction. [Embodiment Item 17] The method according to any one of embodiments 1 to 16, characterized in that the step of inserting the signal transmitting device percutaneously includes the step of moving the signal transmitting device in a downward-upward direction. [Embodiment 18] The method according to any one of embodiments 1 to 17, characterized in that the step of inserting the signal transmitting device percutaneously includes the step of moving the signal transmitting device in an upward-downward direction. [Implementation item 19] The method according to any one of embodiments 1 to 18, characterized in that the step of percutaneously inserting the signal transmitting device into the neck includes the step of percutaneously inserting the signal transmitting device along an insertion path that is angled with respect to the middle sagittal plane. [Embodiment 20] The method according to embodiment 19, characterized in that the insertion path includes a first path portion that forms a first angle with respect to the central sagittal plane and a second path portion that forms a second angle with respect to the central sagittal plane, wherein the second angle is different from the first angle. [Implementation Clause 21] The method according to embodiment 20, characterized in that the first path portion is located near the insertion site, and the step of percutaneously inserting the signal transmitting device along the second path portion includes the step of percutaneously inserting the signal transmitting device along the second path portion at a second angle greater than the first angle. [Embodiment Section 22] The method according to any one of embodiments 1 to 21, further comprising the step of transmitting the above-mentioned modulated signal by the above-mentioned signal transmitting device, wherein the step of transmitting the above-mentioned modulated signal includes the step of generating a caudal traction effect to at least partially address the sleep apnea of ​​the patient. [Embodiment 23] The method according to any one of embodiments 1 to 22, further comprising the step of transmitting the above-mentioned modulated signal by the above-mentioned signal transmitting device, wherein the step of transmitting the above-mentioned modulated signal includes a step of at least partially preventing the collapse of the patient's airway. [Embodiment Section 24] The method according to any one of embodiments 1 to 23, further comprising the step of transmitting the above-mentioned modulated signal by the above-mentioned signal transmitting device, wherein the step of transmitting the above-mentioned modulated signal includes the step of at least partially preventing collapse of at least a portion of the posterior palatal tissue of the patient. [Embodiment 25] The method according to embodiment 24, characterized in that the step of preventing at least a portion of the collapse of the posterior palatal tissue of the patient includes the step of preventing at least a portion of the posterior velopharynx and / or posterior pharyngeal tissue of the patient. [Embodiment Clause 26] The method according to any one of embodiments 1 to 25, further comprising the step of transmitting the above-mentioned modulated signal by the above-mentioned signal transmitting device, wherein the step of transmitting the above-mentioned modulated signal includes the step of reducing the number, frequency, and / or severity of one or more apnea events experienced by the patient over a predetermined period of time. [Embodiment Clause 27] The method according to any one of embodiments 1 to 26, further comprising the step of transmitting the above-mentioned modulated signal by the above-mentioned signal transmitting device, wherein the step of transmitting the above-mentioned modulated signal includes the step of reducing the number, frequency, and / or severity of one or more respiratory depression events experienced by the patient over a predetermined period of time. [Embodiment 28] The method according to embodiment 26 or embodiment 27, characterized in that the above-mentioned predetermined period includes the period during which the above-mentioned modulated signal is transmitted. [Embodiment Section 29] The method according to any one of embodiments 26 to 28, characterized in that the above-mentioned predetermined period includes a certain period after the transmission of the above-mentioned modulated signal. [Embodiment 30] The steps include generating physiological data using one or more sensors of the above-mentioned signal transmission device, The method according to any one of embodiments 1 to 29, further comprising the step of sending at least one of the above-mentioned modulated signals to the target tissue based on the above-mentioned generated physiological data. [Embodiment 31] The method according to embodiment 30, characterized in that the step of transmitting the above-mentioned modulated signal includes at least one step of adjusting one or more parameters of the modulated signal based on the generated physiological data. [Embodiment 32] The method according to any one of embodiments 1 to 31, further comprising the step of receiving power wirelessly by the antenna of the signal transmission device. [Embodiment 33] The method according to embodiment 32, characterized in that the step of receiving the above power wirelessly includes the step of receiving RF power. [Embodiment 34] The method according to embodiment 32, characterized in that the step of receiving the above power wirelessly includes the step of receiving the above power inductively. [Embodiment 35] The method according to any one of embodiments 32 to 34, further comprising the step of storing at least a portion of the power received above in a charge storage device. [Embodiment 36] The method according to embodiment 35, characterized in that the charge storage device has a total charge storage capacity of 1 second or more, 5 seconds or more, 10 seconds or more, 15 seconds or more, 20 seconds or more, 25 seconds or more, 30 seconds or more, 1 minute or more, 2 minutes or more, or 5 minutes or more. [Embodiment 37] A method for addressing sleep apnea in patients, the above method is The steps include: programming a first signaling device to send a first modulated signal from a location at least near the patient's cervical nerve loop to the patient's first target tissue; A method characterized by including a step of programming a second signaling device to send a second modulated signal to a second target tissue of the patient that is different from the first target tissue and is located near at least one anterior branch of the patient's hypoglossal nerve. [Embodiment 38] The step of programming the first signaling device includes the step of programming the first signaling device to transmit the first modulated signal with first signaling parameters, The method according to embodiment 37, characterized in that the step of programming the second signaling device includes the step of programming the second signaling device to transmit the second modulated signal with second signaling parameters different from the first signaling parameters. [Embodiment 39] The step of programming the first signal transmitting device includes the step of programming the first signal transmitting device to transmit the first modulated signal with a first amplitude, The method according to embodiment 37 or 38, characterized in that the step of programming the second signaling device includes the step of programming the second signaling device to transmit the second modulated signal with a second amplitude different from the first amplitude. [Embodiment Item 40] The above step of programming the signal transmitting device includes the step of programming the first signal transmitting device to transmit the first modulated signal at a first frequency, The method according to any one of embodiments 37 to 39, characterized in that the step of programming the second signal transmitting device includes the step of programming the second signal transmitting the second modulated signal at a second frequency different from the first frequency. [Embodiment Item 41] The step of programming the first signaling device includes the step of programming the first signaling device to transmit the first modulated signal with a first pulse width, The method according to any one of embodiments 37 to 40, characterized in that the step of programming the second signaling device includes the step of programming the second signaling device to transmit the second modulated signal with a second pulse width different from the first pulse width. [Embodiment Section 42] The step of programming the first signaling device includes the step of programming the first signaling device to change the amplitude of the first modulated signal during insertion, The method according to any one of embodiments 37 to 41, characterized in that the step of programming the second signal transmitting device includes the step of programming the second signal transmitting device to change the amplitude of the second modulated signal during transmission. [Embodiment Item 43] The method according to embodiment 42, characterized in that the step of changing the amplitude of one or both of the first modulated signal and the second modulated signal includes the step of gradually increasing the amplitude from a first value to a second value greater than the first value. [Embodiment Item 44] The step of programming the first signaling device includes the step of programming the first signaling device to transmit the first modulated signal over a certain period of time, The method according to any one of embodiments 37 to 43, characterized in that the step of programming the second signaling device includes the step of programming the second signaling device to transmit the second modulated signal during the period described above. [Embodiment Item 45] The step of programming the first signaling device includes the step of programming the signaling device to transmit the first modulated signal for a first period of time. The method according to any one of embodiments 37 to 44, characterized in that the step of programming the second signaling device includes the step of programming the second signaling device to transmit the second modulated signal for a second period that is at least partially different from the first period. [Embodiment Item 46] The method according to embodiment 45, characterized in that the second period described above is after the expiration of the first period described above. [Embodiment Item 47] The method according to embodiment 45, characterized in that the second period described above is parallel to a portion of the first period described above. [Embodiment 48] The step of programming the signal transmitting device to transmit the first modulated signal includes at least one step of programming the first signal transmitting device to transmit the first modulated signal based on data received by the sensor, and / or The method according to any one of embodiments 37 to 47, characterized in that the step of programming the second signal transmitting device to transmit the second modulated signal includes at least one step of programming the second signal transmitting device to transmit the second modulated signal based on data received by the sensor. [Embodiment Item 49] The step of programming the first signaling device to transmit the first modulated signal based on data received by the sensor includes at least one step of programming the first signaling device to change at least one first signaling parameter of the first modulated signal based on the data or a change in the data, and / or The method according to Embodiment 48, wherein the step of programming the second signaling device to transmit the second modulated signal based on data received by the sensor comprises at least one step of programming the second signaling device to change at least one second signaling parameter of the second modulated signal based on the data or a change in the data. [Embodiment 50] A method for addressing sleep apnea in patients, the above method is The steps include activating the first signal transmission device described above and transmitting a first modulated signal from a location at least near the patient's cervical nerve trap to the patient's first target tissue, A method comprising the step of activating a second signaling device to send a second modulated signal to a second target tissue of the patient that is different from the first target tissue and located near at least one anterior branch of the patient's hypoglossal nerve. [Embodiment 51] A method for addressing sleep apnea in patients, the above method is The procedure includes the step of percutaneously inserting an implantable signaling device at the insertion site on the patient's neck, The step includes moving the signal transmitting device toward the branch of the patient's cervical nerve loop that innervates the patient's sternohyoid muscle and sternothyroid muscle, The step of implanting the signal transmitting device at a target site located at least near the motor site of the branch that innervates the sternohyoid muscle or the sternothyroid muscle, wherein the signal transmitting device has at least one electrode positioned to transmit a modulated signal to tissue at least near the target site. A method characterized by comprising the step of sending a modulated signal to at least a portion of the above-mentioned branch to induce a motor response in one or both of the sternohyoid muscle and the sternothyroid muscle, thereby addressing the sleep apnea of ​​the patient. [Embodiment 52] The method according to embodiment 51, wherein the branch includes a first subbranch that innervates the sternohyoid muscle and a second subbranch that innervates the sternothyroid muscle, and the step of implanting the signaling device at the target location includes the step of implanting the signaling device at least partially between the first subbranch and the second subbranch. [Embodiment 53] The method according to embodiment 51, wherein the branch includes a first subbranch that innervates the sternohyoid muscle and a second subbranch that innervates the sternothyroid muscle, and the step of implanting the signaling device at the target location includes the step of implanting the signaling device across the first subbranch and the second subbranch. [Embodiment 54] The method according to embodiment 51, wherein the branch includes a first subbranch that innervates the sternohyoid muscle and a second subbranch that innervates the sternothyroid muscle, and the step of implanting the signaling device at the target location includes the step of implanting the nerve signaling device laterally to the first subbranch and the second subbranch. [Embodiment 54] The method according to embodiment 51, wherein the moving portion of the branch includes a plurality of forward branches, and the step of implanting the signal transmitting device at the target location includes the step of implanting the signal transmitting device and transmitting the modulated signal to each of the plurality of forward branches. [Embodiment 55] The method according to embodiment 54, wherein the step of implanting the signal transmitting device and transmitting the modulated signal to each of the plurality of forward branches includes the step of implanting the signal transmitting device such that the electrode array of the signal transmitting device is located at least substantially laterally with respect to at least one subset of the plurality of forward branches. [Embodiment 56] A system for addressing respiratory problems in patients, the above system is An implantable signal transmission device positioned to transmit modulated signals to the cervical nerve trap of the patient, The above-mentioned implantable signal transmission device includes a controller that is communicatively coupled to it, and the controller is Receiving input corresponding to the threshold of the above patient, At least one of the modulation parameters is determined based on the input. A system characterized in that it is configured to issue commands to the above-mentioned signal transmission device and generate the above-mentioned modulated signal based on the above-mentioned modulation parameters in at least one of them. [Embodiment 57] The system according to embodiment 56, characterized in that the above modulation threshold includes an awakening threshold at which the patient awakens from sleep due to the above modulation signal. [Embodiment 58] The system according to embodiment 56 or embodiment 57, characterized in that the above modulation threshold includes a perceptual threshold at which the patient consciously perceives the transmission of the above-mentioned modulated signal. [Embodiment 59] The system according to any one of embodiments 56 to 58, characterized in that the above modulation parameter includes the amplitude of the above modulation signal. [Embodiment 60] The system according to any one of embodiments 56 to 59, characterized in that the controller is configured to obtain the modulated signal by reducing the modulated signal by a predetermined amount. [Implementation clause 61] The system according to any one of embodiments 56 to 60, characterized in that the above modulation threshold is associated with a first value of the above modulation parameter, and the controller is configured to determine a second value of the above modulation parameter that is different from the above first value. [Embodiment Clause 62] The system according to any one of embodiments 56 to 61, characterized in that the above modulation threshold is related to a first value of the above modulation parameter, and the controller is configured to determine a second value of the above modulation parameter that is smaller than the first value. [Embodiment 63] The system according to any one of embodiments 56 to 62, characterized in that the implantable signaling device is a first implantable signaling device, the modulated signal is a first modulated signal, and the system further includes a second implantable signaling device positioned to deliver a second modulated signal to the hypoglossal nerve of the patient. [Embodiment Item 64] A method for addressing the respiratory distress of the above patient, the above method is: The steps include sending a first modulated signal to the cervical nerve trap of the patient, The steps include determining a first value of a modulation parameter associated with the modulation threshold of the cervical nerve loop in the above patient, A method characterized by comprising the step of sending a second modulated signal to the patient's cervical nerve trap at a second value of the modulation parameter that is different from the above modulation threshold. [Embodiment 65] The method according to embodiment 64, characterized in that the above modulation parameter includes an awakening threshold at which the patient awakens from sleep due to the above modulation signal. [Implementation clause 66] The method according to embodiment 64 or embodiment 65, characterized in that the modulation threshold includes a perceptual threshold at which the patient consciously perceives the transmission of the modulation signal. [Embodiment 67] The method according to any one of embodiments 64 to 66, characterized in that the above modulation parameter includes the amplitude of the above-mentioned modulated signal. [Embodiment 68] The method according to any one of embodiments 64 to 67, characterized in that the step of transmitting the second modulated signal includes the step of decreasing the first value of the modulation parameter by a predetermined amount to obtain the second value of the modulation parameter. [Embodiment Item 69] The method according to any one of embodiments 64 to 68, characterized in that the second value of the above modulation parameter is less than the first value. [Embodiment Clause 70] A system for addressing respiratory problems in patients, the above system is An implantable signal transmission device positioned to transmit modulated signals to the cervical nerve trap of the patient, The above-mentioned implantable signal transmission device includes a controller that is communicatively coupled to it, and the controller is Upon receiving an input corresponding to the modulation threshold of the cervical nerve loop in the above patient, At least one modulation parameter value different from the above modulation threshold is determined based on the above input. A system configured to issue commands to the above-mentioned embedded signals and generate at least one of the above-mentioned modulated signals based on the above-mentioned modulation parameter values. [Embodiment Clause 71] The system according to embodiment 70, wherein the above modulation parameter value is smaller by a predetermined amount than the above modulation threshold value. [Embodiment 72] The system according to embodiment 70, wherein the above modulation threshold is a first value of the modulation parameter, and the above modulation parameter value is a second value of the modulation parameter that is smaller than the above first value. [Embodiment Item 73] The above modulation parameters include the modulation amplitude, as described in Embodiment 72 of the system. [Embodiment Clause 74] The system according to embodiment 70, wherein the modulation threshold includes an awakening threshold at which the patient awakens from sleep due to the modulation signal. [Embodiment Item 75] The system according to embodiment 70, wherein the modulation threshold includes a perceptual threshold at which the patient consciously perceives the transmission of the modulated signal. [Embodiment Clause 76] The above modulation parameters include the modulation pulse width, as described in Embodiment 70 of the system. [Embodiment Clause 77] The system according to embodiment 70, wherein the above modulation parameter includes a modulation pulse width, the above modulation threshold includes a first pulse width value, and the above modulation parameter value includes a second pulse width value greater than the value of the first pulse width. [Embodiment 78] A method for addressing respiratory distress in patients, the above method is A step of sending a first modulated signal to the cervical nerve trap of the patient to produce a first response in the muscle of the patient innervated by the cervical nerve trap, The steps include obtaining a first value of a modulation parameter associated with the modulation threshold of the cervical nerve loop in the above patient, A method comprising the step of sending a second modulated signal to the cervical nerve trap of the patient at a second value of the modulation parameter different from the modulation threshold, thereby causing a second response in the muscle different from the first response. [Embodiment Clause 79] The method according to embodiment 78, wherein the first reaction described above includes a whole muscle reaction, and the second reaction described above is smaller than the whole muscle reaction described above. [Embodiment 80] The method according to embodiment 78 or 79, wherein the muscles include the sternothyroid muscle and / or the sternohyoid muscle of the patient. [Embodiment 81] The method according to any one of embodiments 78 to 80, wherein the step of obtaining the first value of the modulation parameter associated with the modulation threshold includes the step of obtaining the first value of the modulation parameter associated with the arousal threshold at which the patient wakes from sleep due to modulation of the cervical nerve loop. [Embodiment 82] The method according to any one of embodiments 78 to 81, wherein the step of obtaining the first value of the modulation parameter associated with the modulation threshold includes the step of obtaining the first value of the modulation parameter associated with a perceptual threshold at which the patient consciously perceives the modulation of the cervical nerve loop. [Embodiment 83] The step of obtaining the above value of the above modulation parameter includes the step of obtaining a first modulation amplitude associated with the above modulation threshold of the patient's cervical nerve loop, The method according to any one of embodiments 78 to 82, wherein the step of transmitting the second modulated signal includes the step of transmitting the second modulated signal with a second modulated amplitude smaller than the first modulated amplitude. [Embodiment 84] The method according to any one of embodiments 78 to 83, wherein the step of transmitting the second modulated signal includes the step of reducing the first value of the modulation parameter by a predetermined amount. [Embodiment 85] The method according to any one of embodiments 78 to 84, wherein the second value of the above modulation parameter is smaller than the first value and the above modulation threshold. [Embodiment 86] A method for addressing sleep apnea in patients, the above method is The procedure involves the percutaneous insertion of an implantable signaling device at the insertion site on the patient's neck, The steps include moving the above signal transmitting device toward the patient's cervical nerve loop from the outside to the inside, A method comprising the step of implanting the signal transmitting device at a target location at least near the cervical nerve loop, wherein the signal transmitting device has at least one electrode positioned to transmit a modulated signal to tissue at least near the target location. [Embodiment 87] The method according to embodiment 86, wherein the step of moving the signal transmitting device includes moving the signal transmitting device from the patient's midsagittal plane at an angle of about 20° to about 80° with respect to the midsagittal plane. [Embodiment 88] The method according to embodiment 86 or 87, wherein the step of moving the signal transmitting device includes moving the signal transmitting device from the patient's midsagittal plane at an angle of about 45° to about 80° with respect to the midsagittal plane. [Embodiment Item 89] The method according to any one of embodiments 86 to 88, further comprising the step of turning the patient's head backward to expose the insertion site before percutaneously inserting the implantable signaling device described above. [Embodiment Clause 90] The method according to any one of embodiments 86 to 89, wherein the step of implanting the signal transmitting device includes implanting the signal transmitting device at least near the inferior branch of the cervical nerve loop in the patient. [Implementation item 91] The method according to any one of embodiments 86 to 90, wherein the step of implanting the signal transmitting device includes implanting the signal transmitting device at least near a branch of the cervical nerve loop that innervates the sternohyoid muscle, sternothyroid muscle, or omohyoid muscle of the patient. [Embodiment Clause 92] The method according to embodiments 86-91, wherein the step of implanting the signaling device includes implanting the signaling device at least near a branch of the cervical nerve loop that innervates both the patient's sternohyoid muscle and the patient's sternothyroid muscle. [Embodiment Item 93] The method according to any one of embodiments 86 to 92, wherein the step of implanting the signal transmitting device includes implanting the signal transmitting device at least near the distal end of the branch of the cervical nerve loop and transmitting the modulated signal to the motor site of the branch that innervates one of the patient's sternohyoid muscle, the patient's sternothyroid muscle, or the patient's omohyoid muscle. [Embodiment section 94] The method according to any one of embodiments 86 to 93, wherein the step of implanting the signal transmitting device at least near the target location includes the step of implanting the signal transmitting device at least near the sternothyroid muscle, sternohyoid muscle, omohyoid muscle and / or thyrohyoid muscle of the patient. [Embodiment Item 95] The method further includes sending the modulated signal to the target tissue to enhance the stability of at least a portion of the patient's airway, the steps of (i) increasing the stiffness of at least a portion of the pharyngeal wall of the patient's airway, (ii) increasing the dimensions of the patient's posterior palatine airway, and (iii) an airflow method through at least a portion of the airway. [Embodiment section 96] The method according to any one of embodiments 86 to 94, further comprising the step of sending the above-mentioned modulated signal to the above-mentioned target tissue to generate a caudal traction force by causing one or both of the patient's hyoid bone and / or the patient's thyroid cartilage to descend. [Embodiment Clause 97] The method according to any one of embodiments 86 to 95, wherein the step of inserting the signal transmitting device percutaneously includes the step of moving the signal transmitting device in a forward-to-rear direction. [Embodiment Item 98] The method according to any one of embodiments 86 to 97, wherein the step of inserting the signal transmitting device percutaneously includes the step of moving the signal transmitting device in a downward direction from downward to upward. [Embodiment Clause 99] The method according to any one of embodiments 86 to 97, wherein the step of inserting the signal transmitting device percutaneously includes the step of moving the signal transmitting device in a direction from top to bottom.

[0111] Based on the above, it is believed that by positioning the signaling device to send the modulated signal to the cervical nerve loop AC, airway collapse in the posterior palatine (e.g., velopharynx and reposterior pharyngeal) region of the patient's airway can be reduced or prevented without affecting or having little effect on base of tongue collapse, and / or without interfering or having little interference with the ability of other modulations (hypoglossal nerve modulation) to cause or prevent base of tongue collapse. In addition, the combination of cervical nerve loop AC modulation and hypoglossal nerve modulation is expected to provide a therapeutic solution for widespread collapse sites in the upper airway, resulting in (1) more effective treatment for patients whose collapse pattern (e.g., velopharynx collapse pattern) is not fully targeted by hypoglossal nerve modulation alone, and (2) a broader potential patient population for which nerve modulation can be an effective treatment by targeting additional sites. For example, and as described herein, multi-site signal delivery is expected to increase the potential patient responder population to include, for example, patients who would not respond to hypoglossal nerve modulation alone if not configured as described above (e.g., patients with initial velopharyngeal collapse, no soft palate junction, PMI > 32, and / or complete concentric airway collapse). In these embodiments and other embodiments, the positioning / orientation described herein is expected to reduce or minimize changes to the position / orientation of the signal delivery device during insertion and / or after implantation, and / or improve the speed and / or accuracy of positioning the signal delivery device at least near the target location.

[0112] As recognized, specific embodiments of the present technology have been described for illustrative purposes, but various modifications can be made without departing from the present technology. For example, the signaling device may have leads, and one or more electrodes of the signaling device may be supported by leads. Certain aspects of the present technology described in relation to specific embodiments may be combined or omitted in other embodiments. For example, two signaling devices can be implanted to target patient tissue (e.g., left and right cervical ligaments) symmetrically and / or to mark different tissues on the left and right sides of the patient (left cervical ligament and right infrahyoid girdle). Furthermore, while advantages related to certain embodiments of the disclosed prosthetics and techniques have been described in relation to those embodiments, other embodiments may also perform such advantages, and not all embodiments necessarily perform such advantages that fall within the scope of the present technology. Accordingly, the present disclosure and related technologies may include other embodiments not expressly shown or described herein.

[0113] In this specification, "and / or" as in "A and / or B" refers to A alone, B alone, or both A and B. Unless otherwise specified, the terms "approximately," "about," and "roughly" refer to values ​​within 10% of the stated value. For example, the expression "about 100" refers to a range (including the end value) between 90 and 110. When relative terms are used in reference to something that does not contain a numerical value, such terms are given an ordinary meaning to those skilled in the art.

[0114] This disclosure remains in effect until any reference cited herein conflicts with it.

Claims

1. A system for addressing respiratory problems in patients, wherein the system is An implantable signal transmission device positioned to transmit a modulated signal to the patient's cervical nerve trap, The implanted signal transmission device includes a controller that is communicatively coupled to it, and the controller is Upon receiving an input corresponding to the modulation threshold of the patient's cervical nerve loop, At least one modulation parameter value different from the modulation threshold is determined based on the input, A system configured to issue commands to the embedded signals and generate at least one of the modulated signals based on the modulation parameter values.

2. The system according to claim 1, wherein the modulation parameter value is smaller by a predetermined amount than the modulation threshold value.

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

4. The system according to claim 3, wherein the modulation parameter includes the modulation amplitude.

5. The system according to claim 1, wherein the modulation threshold includes an awakening threshold at which the patient awakens from sleep due to the modulation signal.

6. The system according to claim 1, wherein the modulation threshold includes a perceptual threshold at which the patient consciously perceives the transmission of the modulated signal.

7. The system according to claim 1, wherein the modulation parameter includes the modulation pulse width.

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

9. A method for addressing respiratory distress in patients, wherein the method is A step of sending a first modulated signal to the patient's cervical nerve trap to produce a first response in the patient's muscle innervated by the cervical nerve trap, The steps include obtaining a first value of a modulation parameter associated with the modulation threshold of the cervical nerve loop of the patient, A method comprising the steps of sending a second modulated signal to the patient's cervical nerve trap at a second value of the modulation parameter different from the modulation threshold, thereby causing a second response in the muscle different from the first response.

10. The method according to claim 9, wherein the first reaction includes a whole muscle reaction, and the second reaction is smaller than the whole muscle reaction.

11. The method according to claim 9, wherein the muscle includes the patient's sternothyroid muscle and / or the patient's sternohyoid muscle.

12. The method according to claim 9, wherein the step of obtaining the first value of the modulation parameter associated with the modulation threshold includes the step of obtaining the first value of the modulation parameter associated with the arousal threshold at which the patient wakes from sleep due to modulation of the cervical nerve loop.

13. The method according to claim 9, wherein the step of obtaining the first value of the modulation parameter associated with the modulation threshold includes the step of obtaining the first value of the modulation parameter associated with a perceptual threshold at which the patient consciously perceives the modulation of the cervical nerve loop.

14. The step of obtaining the value of the modulation parameter includes the step of obtaining a first modulation amplitude associated with the modulation threshold of the patient's cervical nerve loop, The method according to claim 9, wherein the step of transmitting the second modulated signal includes the step of transmitting the second modulated signal with a second modulated amplitude smaller than the first modulated amplitude.

15. The method according to claim 9, wherein the step of transmitting the second modulated signal includes the step of reducing the first value of the modulation parameter by a predetermined amount.

16. The method according to claim 9, wherein the second value of the modulation parameter is smaller than the first value and the modulation threshold.

17. A method for addressing sleep apnea in patients, wherein the method is: The steps include: inserting an implantable signaling device percutaneously at the insertion site on the patient's neck; The steps include moving the signal transmitting device toward the patient's cervical nerve loop from the outside to the inside, A method comprising the step of implanting the signal transmitting device at a target location at least near the cervical nerve loop, wherein the signal transmitting device has at least one electrode positioned to transmit a modulated signal to tissue at least near the target location.

18. The method according to claim 17, wherein the step of moving the signal transmitting device includes moving the signal transmitting device from the patient's midsagittal plane at an angle of about 20° to about 80° with respect to the midsagittal plane.

19. The method according to claim 17, wherein the step of moving the signal transmitting device includes moving the signal transmitting device from the patient's midsagittal plane at an angle of about 45° to about 80° with respect to the midsagittal plane.

20. The method according to claim 17, further comprising the step of turning the patient's head backward to expose the insertion site before percutaneously inserting the implantable signaling device.

21. The method according to claim 17, wherein the step of implanting the signaling device includes implanting the signaling device at least near the inferior branch of the cervical nerve loop in the patient.

22. The method according to claim 17, wherein the step of implanting the signaling device includes implanting the signaling device at least near a branch of the cervical nerve loop that innervates the sternohyoid muscle, sternothyroid muscle, or omohyoid muscle of the patient.

23. The method according to claim 17, wherein the step of implanting the signaling device includes implanting the signaling device at least near a branch of the cervical nerve loop that innervates both the patient's sternohyoid muscle and the patient's sternothyroid muscle.

24. The method according to claim 17, wherein the step of implanting the signal transmitting device includes implanting the signal transmitting device at least near the distal end of the branch of the cervical nerve loop and transmitting the modulated signal to the motor site of the branch that innervates one of the patient's sternohyoid muscle, the patient's sternothyroid muscle, or the patient's omohyoid muscle.

25. The method according to claim 17, wherein the step of implanting the signaling device at least near the target location includes the step of implanting the signaling device at least near the sternothyroid muscle, sternohyoid muscle, omohyoid muscle and / or thyrohyoid muscle of the patient.

26. The method according to claim 17, further comprising the step of sending the modulated signal to a target tissue to enhance the stability of at least a portion of the patient's airway, the step of which includes one or more of the following steps: (i) increasing the stiffness of at least a portion of the pharyngeal wall of the patient's airway; (ii) increasing the dimensions of the patient's posterior palatine airway; and (iii) reducing the resistance to airflow through the at least portion of the airway.

27. The method according to claim 17, further comprising the step of sending the modulated signal to a target tissue to generate a caudal traction force by causing one or both of the patient's hyoid bone and / or the patient's thyroid cartilage to descend.

28. The method according to claim 17, wherein the step of inserting the signal transmitting device percutaneously includes the step of moving the signal transmitting device in a forward-to-rear direction.

29. The method according to claim 17, wherein the step of inserting the signal transmitting device percutaneously includes the step of moving the signal transmitting device in a downward direction from downward to upward.

30. The method according to claim 17, wherein the step of inserting the signal transmitting device percutaneously includes the step of moving the signal transmitting device in a direction from top to bottom.

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