Signal delivery devices and associated methods and systems for treatment of sleep

Abstract

The present technology generally relates to systems and methods for addressing sleep apnea in a patient. At least some embodiments include an electrode array and a controller. The electrode array may include one or more electrodes and may be configured to be implanted at least near a target tissue of a patient in an orientation where at least a vector component of the orientation is aligned along a lower-upper axis of the patient. A controller may be communicatively coupled to the electrode array and include one or more non-transitory computer-readable media having instructions that, when executed by one or more processors of the controller, cause the controller to direct electrical signals to be delivered from the electrode array to target tissue.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Application No. 63 / 434,803, filed December 22, 2022, and U.S. Provisional Application No. 63 / 456,752, filed April 3, 2023. This application is related to U.S. Non-Provisional Application No. 18 / 331,109, filed June 7, 2023. The entire contents of each of the above applications are incorporated herein by reference. Technical Field

[0003] The present technology relates to signal delivery devices for treating sleep apnea, and associated methods and systems. Background Art

[0004] Obstructive sleep apnea (OSA) is a medical condition in which a patient's upper airway becomes (partially or completely) blocked during sleep, leading to arousals. Repeated occlusion of the upper airway can lead to sleep fragmentation, which in turn can cause sleep deprivation, daytime fatigue, and / or discomfort. More severe cases of OSA can increase a patient's risk of stroke, cardiac arrhythmias, hypertension, and / or other conditions.

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

[0006] Several treatments are available for OSA, including surgery, continuous positive airway pressure (CPAP) machines, and electrical stimulation of muscles or nerves associated with the upper airway to move the tongue (or other upper airway tissue). Surgical techniques include procedures that remove portions of the patient's tongue and / or soft palate, as well as other procedures that attempt to prevent the tongue from collapsing into the posterior pharynx. These surgical techniques are highly invasive. CPAP machines attempt to maintain upper airway patency by applying positive air pressure to the patient's nose and mouth. However, these machines are uncomfortable, bulky, and can have low compliance rates.

[0007] Some electrical stimulation techniques attempt to prevent the tongue from collapsing into the back of the pharynx by causing it to protrude forward (e.g., in an anterior direction) and / or flatten during sleep. However, existing techniques for electrically stimulating nerves in a patient's oral cavity suffer from being too invasive and / or insufficiently effective. Therefore, there is a need for improved, minimally invasive treatments for OSA and other sleep disorders. BRIEF DESCRIPTION OF THE DRAWINGS

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

[0009] Figure 1B is a side cross-sectional view depicting a portion of a patient's genioglossus muscle and hypoglossal nerve.

[0010] Figure 1C is a lateral anatomy diagram depicting a portion of a patient's genioglossus muscle and hypoglossal nerve.

[0011] Figure 1D is a side view depicting a portion of a patient's upper airway and a signal delivery device positioned in accordance with an embodiment of the present technology.

[0012] Figure 2A is a side view of a portion of a patient's upper airway depicting a signal delivery device insertion path in accordance with an embodiment of the present technology.

[0013] Figure 2B is a diagram illustrating an embodiment of the present technology along Figure 2A Lateral anatomical view of the implanted orientation of the signal delivery device after insertion of the signal delivery device insertion pathway.

[0014] Figure 2C and Figure 2D A submental and coronal cross-sectional view, respectively, of a portion of a patient's upper airway depicting an embodiment of the present technology. Figure 2A The signal delivery device is inserted into the path.

[0015] Figures 3A-3C is a side cross-sectional view of a portion of a patient's upper airway depicting respective signal delivery device insertion pathways according to embodiments of the present technology.

[0016] Figures 4A-4C is a coronal cross-sectional view of a portion of a patient's upper airway depicting respective signal delivery device insertion pathways according to embodiments of the present technology.

[0017] Figures 5A-5E is a side view of a patient's tongue and upper airway depicting corresponding signal delivery device stimulation patterns in accordance with an embodiment of the present technology.

[0018] Figures 6A-6C is a side cross-sectional illustration of a patient's oral cavity and upper airway depicting a representative tongue collapse pattern that can be addressed by techniques in accordance with embodiments of the present technology.

[0019] Figure 7A and Figure 7B sectional side view and submental sectional view, respectively, depicting a signal delivery device insertion path according to an embodiment of the present technology.

[0020] Figure 8A and Figure 8Bsectional side view and submental sectional view, respectively, depicting a signal delivery device insertion path according to an embodiment of the present technology.

[0021] Figure 9A and Figure 9B sectional side view and submental sectional view, respectively, depicting a signal delivery device insertion path according to an embodiment of the present technology.

[0022] Figure 10 is a side view depicting another signal delivery device insertion path in accordance with an embodiment of the present technology.

[0023] Figure 11 is a side view depicting another signal delivery device insertion path in accordance with an embodiment of the present technology.

[0024] Figure 12 Graphs illustrating patient data obtained in response to delivering electrical signals to target tissue in accordance with embodiments of the present technology.

[0025] Figure 13 is a table including patient data obtained in response to delivering an electrical signal to a target tissue in accordance with an embodiment of the present technology.

[0026] Figure 14 Graphs showing patient data obtained by directing electrical signals to distal branches of a patient's hypoglossal nerve in accordance with an embodiment of the present technology.

[0027] Figure 15 is a graph of airflow data for a patient receiving electrical signals delivered in accordance with an embodiment of the present technology.

[0028] Figure 16 is a side view of a portion of a patient's upper airway depicting an insertion guide configured in accordance with an embodiment of the present technology.

[0029] Figure 17 is a partially schematic side view illustrating another signal delivery device configured in accordance with an embodiment of the present technology.

[0030] Figure 18 Shown is a representative set of implantation tools for implanting a signal delivery device in accordance with embodiments of the present technology.

[0031] Figure 19 is a block diagram illustrating elements of a system for treating sleep disorders in accordance with an embodiment of the present technology. DETAILED DESCRIPTION

[0032] For ease of reading, this technology is discussed under the following headings:

[0033] Title 1 :"introduction"

[0034] Title 2 : "Overall patient physiology" (focused on Figures 1A-1D )

[0035] Title 3 : "Representative insertion pathways and signal delivery device locations" (focused on Figure 2A-11 )

[0036] Title 4 : "Representative experimental data" (focusing on Figure 12-15 )

[0037] Title 5 : "Additional devices, systems and methods" (focused on Figure 16-19 )

[0038] Title 6 : "Example"

[0039] Although embodiments of the present technology are described under the selected headings indicated above, other embodiments of the present technology may include elements discussed under multiple headings. Accordingly, the fact that an embodiment may be discussed under a particular heading does not necessarily limit the embodiment to only the elements discussed under that heading.

[0040] 1. introduction

[0041] Electrical stimulation for obstructive sleep apnea (OSA) typically involves delivering an electrical current that modulates nerves and / or muscles, for example, to move the tongue and / or other soft tissues. The electrical stimulation can, in turn, remove obstruction from the upper airway and / or prevent the tongue or other soft tissues from collapsing and obstructing the airway. As used herein, the terms "modulate" and "stimulate" are used interchangeably to refer to, for example, an effect on nerves and / or muscles, which in turn affects one or more motor functions (e.g., breathing-related motor functions).

[0042] Disclosed herein are representative methods and apparatus for reducing the occurrence and / or severity of respiratory disorders, such as obstructive sleep apnea (OSA), OSA with complete concentric collapse (CCC), central sleep apnea, and the like. According to representative embodiments, a minimally invasive signal delivery device is implanted near or adjacent to one or more tissues of a patient's upper airway, such as one or more nerves innervating the patient's oral cavity, soft palate, oropharynx, and / or epiglottis. Representative nerves include the hypoglossal nerve, branches of the cervical loop, and / or the vagus nerve, which are located near and / or around the oral cavity or in the neck. The signal delivery device can be implanted into the patient via percutaneous injection, intravenously (via, for example, the lingual artery, lingual vein, or other suitable blood vessels), invasively (via one or more incisions formed, for example, intraorally, sublingually, submandibularly, or by drilling an access hole, for example, through the patient's mandible), via a combination thereof, and / or using other suitable implantation techniques. In a preferred embodiment, the signal delivery device is implanted via minimally invasive percutaneous injection, for example, without drilling an access hole and / or forming an incision in the patient. A non-implantable power source (e.g., comprising one or more mouthpiece portions, collar portions, chin strap portions, pillow portions, mattress covering portions, other suitable "wearable devices," and / or one or more adhesive, skin-mounted devices) can wirelessly power an implanted signal delivery device. The signal delivery device emits precisely targeted electrical signals (e.g., pulses) that improve upper airway patency and / or improve oral tissue tone to treat sleep apnea. The electrical signals delivered by the signal delivery device can stimulate at least a portion of the patient's hypoglossal nerve and / or other nerves associated with the patient's upper airway. For example, the signal delivery device can deliver electrical signals to one or more portions of the medial branch of the hypoglossal nerve anterior to the hypoglossal nerve and / or directly to one or both of the patient's genioglossus muscles, e.g., to cause the tongue to move forward / anteriorly (e.g., a net positive protrusive response), downward / inferiorly / caudally, and / or otherwise at least partially or completely prevent the tongue from collapsing into the posterior portion of the patient's pharynx and / or into the upper airway. By moving the tongue forward and / or by preventing the tongue and / or other soft tissue from collapsing into the posterior portion of the patient's pharynx and / or upper airway, the devices and associated methods disclosed herein can further improve the patient's sleep, for example, by moving potentially obstructing tissue in the upper airway / pharynx or preventing such tissue from collapsing and causing an obstruction.

[0043] Many embodiments of the techniques described below can take the form of computer-, machine-, or controller-executable instructions, including programs executed by a programmable computer or controller. Those skilled in the relevant art will appreciate that the techniques can be implemented on computer / controller systems other than those shown and described below. The techniques can be embodied in a special-purpose computer, controller, or data processor that is specifically programmed, configured, or constructed to execute one or more of the computer-executable instructions described below. Accordingly, the terms "computer" and "controller," as used generally herein, refer to any suitable data processor and can include internet appliances and handheld devices (including palmtop computers, wearable computers, tablet computers, cellular or mobile phones, multiprocessor systems, processor-based or programmable consumer electronics, network computers, minicomputers, etc.). Information processed by these computers can be presented on any suitable display medium, including a liquid crystal display (LCD). Manufacturers can also program devices of the disclosed systems to perform at least some of these methods.

[0044] The present technology can also be implemented in a distributed environment, where tasks or modules are executed by remote processing devices linked by a communication network. In a distributed computing environment, program modules or subroutines can be located in local and remote memory storage devices. Various aspects of the technology described below can be stored or distributed on any suitable computer-readable medium, including one or more application-specific integrated circuits (ASICs) (e.g., with addressable memory), as well as distributed electronically over a network. Data structures and data transmissions specific to aspects of the present technology are also within the scope of embodiments of the present technology.

[0045] 2. Overall patient physiological condition

[0046] Representative embodiments described herein include signal delivery devices having electrodes that can be positioned to deliver one or more electrical currents to one or more specific target locations, such as specific nerves and / or specific locations along nerves. Figure 1A The general anatomy of the patient's oral cavity is shown. Such locations include locations along the patient's hypoglossal nerve, branches of the cervical loop, and / or vagus nerve, as well as those nerves that innervate airway muscles other than the tongue (e.g., palatine, oropharyngeal, laryngeal, omohyoid, sternohyoid, and / or sternothyroid muscles). Target locations can be identified relative to any one or any combination of intrinsic or extrinsic muscles, associated nerve branches, and / or portions thereof, and / or other physiological characteristics. Such target locations and / or positions can also be positioned away from salivary glands (e.g., medial to the sublingual salivary glands) and / or other structures to reduce or prevent patient discomfort and / or other undesirable effects.

[0047] Figure 1A A patient P is shown relative to a coordinate system in which the x-axis represents the anterior-posterior direction, the y-axis represents the superior-inferior and / or cranial-caudal direction, and the z-axis represents the medial-lateral direction. Patient P has a hard palate HP that covers the tongue T and forms the roof of the oral cavity OC (e.g., mouth). The hard palate HP includes a bony support BS and, therefore, does not normally deform during respiration. The soft palate SP, formed by soft tissue (such as membranes, fibrous material, adipose tissue, and muscle tissue), extends posteriorly (e.g., in a posterior direction) from the hard palate HP toward the posterior portion of the pharynx PHR. More specifically, the anterior end AE of the soft palate SP is anchored to the posterior end of the hard palate HP, and the posterior end PE of the soft palate SP is not attached. Because the soft palate SP does not contain bone or hard cartilage, the soft palate SP is flexible and can collapse onto the posterior portion of the pharynx PHR and / or swing back and forth (e.g., particularly during sleep). Collapse of these and / or other tissues of the patient P (eg, tongue T) may cause corresponding collapse of the patient's airway, which in turn may cause obstructive sleep apnea and / or other breathing disorders.

[0048] The pharynx (PHR), which transmits air from the oral cavity (OC) and nasal cavity (NC) to the trachea (TR), is the portion of the throat located inferiorly (lower) to the nasal cavity (NC), posteriorly (backward) to the oral cavity (OC), and superiorly (above) to the esophagus (ES). The pharynx (PHR) is separated from the oral cavity (OC) by the palatoglossal arches (PGA), which extend downward on either side to the base of the tongue (T). Although not shown for simplicity, the pharynx (PHR) comprises the nasopharynx, oropharynx, and larynx. The nasopharynx is located between the upper surface of the soft palate (SP) and the walls of the throat (i.e., above the oral cavity (OC). The oropharynx is located posterior to the oral cavity (OC) and extends from the uvula (U) to the level of the hyoid bone (HB). The oropharynx opens anteriorly into the oral cavity (OC). The lateral walls of the oropharynx include the palatine tonsils and are located between the palatoglossal arches (PGA) and the palatopharyngeal arches. The anterior wall of the oropharynx includes the base of the tongue (T) and the epiglottic vallecula. The superior wall of the oropharynx includes the lower surface of the soft palate (SP) and the uvula (U). Because both food and air pass through the pharynx PHR, a flap of connective tissue called the epiglottis EP closes over the glottis (not shown for simplicity) when food is swallowed to prevent aspiration. The pharynx is the part of the throat that connects to the esophagus ES and is located below the epiglottis EP. Below the tongue T is the jaw or mandible M and the geniohyoid muscle GH, one of the muscles that controls the movement of the tongue T. Figure 1B Discussion of the genioglossus muscle, which also controls tongue movement and is a specific target of the presently disclosed therapy.

[0049] The signal delivery device 100 (shown schematically) can be positioned at least near or within one or more target nerves and / or muscle structures and includes a housing 102, one or more electrodes 104, a signal generator 106, and an antenna and / or coil 108. The housing 102 can include a first end 102a and a second end 102b opposite the first end 102a. In some embodiments, the housing 102 has a length of at least 0.5 cm, 1 cm, 1.5 cm, or 2 cm, such as a length of 1.6 cm. In some embodiments, the housing 102 has a width / diameter of at least 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, or 6 mm. The housing 102 can be configured to hermetically contain one or more circuit components of the signal delivery device 100, including the signal generator 106 and / or the antenna 108. All or a portion of the housing 102 can be formed from platinum (Pt), platinum and iridium (PtIr), Ti6AL4V, epoxy, thermoplastic elastomer (TPE), one or more ceramics, and / or one or more other suitable materials. For example, the portion of the housing 102 surrounding the antenna 108 can be formed from epoxy, ceramic, and / or TPE, for example, to prevent or at least partially prevent interference with power transmission to the antenna 108. Optionally, at least a portion of the housing 102 can be electrically activatable and configured to function as an electrode. As described in further detail below, a signal delivery device having the aforementioned characteristics can be minimally invasive while also providing targeted stimulation to various candidate stimulation sites.

[0050] The signal delivery device 100 can be leadless, with each of the electrodes 104 positioned on and / or at least partially surrounding the housing 102 (e.g., the first end 102a of the housing 102). In some embodiments, each of the electrodes 104 can be carried by a lead or flexible member coupled to the housing 102. In these and / or other embodiments, each of the electrodes 104 can be shielded (e.g., circumferentially shielded), segmented (e.g., circumferentially segmented, individually addressable), oriented, at least partially covered, and / or otherwise configured to direct an electric field in a specific direction or directions. The electrodes 104 can be formed of Pt and / or Ir (e.g., Pt90 / Ir10) and / or one or more other suitable materials. Each of the electrodes 104 can have a length (e.g., measured parallel to the longitudinal axis of the housing 102) of at most 0.1 mm, 0.2 mm, 0.25 mm, 0.5 mm, 0.75 mm, 1 mm, or 2 mm, such as 1.5 mm, or another suitable length. Additionally or alternatively, each of the electrodes 104 can be spaced apart from each other (e.g., measured center-to-center or end-to-end) by a distance of at most 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 10 mm, 15 mm, or 20 mm, such as 3.5 mm, 12 mm, or another suitable distance. In the illustrated embodiment, the signal generator 106 and the antenna 108 are at least partially or completely positioned within the housing 102 (e.g., the second end 102 b of the housing 102). In other embodiments, the signal generator 106, antenna 108 and / or other components of the signal delivery device 100 can be contained within a separate housing positioned elsewhere (e.g., subcutaneously in the patient P) and electrically coupled to the electrode 104 via a lead or other connection. The signal delivery device 100 can be secured at least proximate to or within one or more target nerves and / or muscle structures using one or more anchors, sutures and / or other suitable devices. For example, the signal delivery device can be deployed within the patient's body or at least partially external to the patient's body via, for example, a patch, pad, or other wearable device. In some embodiments, at least a portion of the signal delivery device can be positioned or otherwise implanted within the patient's genioglossus or other muscle, for example, to anchor the signal delivery device 100 in place relative to the hypoglossal nerve and / or other target tissue.

[0051] In the illustrated embodiment, the signal delivery device 100 includes four electrodes 104 arranged in a 1x4 array. In other embodiments, the signal delivery device 100 may include more or fewer electrodes 104 and / or electrodes arranged in other suitable patterns. For example, the signal delivery device 100 may include at least 2, 3, 6, 8, 10, or more electrodes, each of which may be arranged in one or more rows and / or one or more columns. Accordingly, in at least some embodiments, the signal delivery device 100 includes electrodes 104 arranged in a 2x4 array, a 3x3 array, a 4x4 array, a 2x6 array, and the like. The increased number of electrodes can improve the extent to which energy can be targeted toward various locations / tissues within the patient's body. In some embodiments, the electrodes 104 may include one or more paddle electrodes, flexible (e.g., foil) electrodes, planar microelectrodes, monopolar electrodes, injectrode electrodes, or the like. ® ) and / or other suitable electrodes.

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

[0053] The power received at antenna 108 can be sent to signal generator 106, which can use the power to generate one or more electrical pulses or signals. In at least some embodiments, the power received at antenna 108 (e.g., AC power) is rectified to DC (via, for example, an AC-DC converter) and then transmitted to a DC-DC converter, a charge pump, and / or a transformer, and converted into pulses having a frequency in the range of from about 10 Hz to about 500 Hz (such as from about 30 Hz to about 300 Hz), or in a lower range (e.g., between about 1 Hz and about 10 Hz). In other embodiments, the pulses can be delivered at a higher frequency (e.g., 10 kHz or higher) and / or in bursts. In a voltage-controlled system, the amplitude of the signal can be from about 1 mV to about 5 V (and in certain embodiments, from 1 V to 2 V), or in a current-controlled system, the amplitude of the signal can be from about 0.5 mA to about 12 mA, or from about 1.5 mA to about 3.5 mA. In the illustrated embodiment, all signal generation functions are performed by signal generator 106; in other embodiments, some or all signal generation functions may be performed by external components. In at least some embodiments, for example, signal delivery device 100 is passive (e.g., does not include signal generator 106) and is configured to receive one or more signals via antenna 108 for application to the patient via electrodes 104. In such embodiments, antenna 108 may be configured to receive signals via inductive power transfer and / or via another suitable power transfer technique. The signal generation and signal delivery functions may be performed by a single implantable device or by multiple devices.

[0054] The signal generated by signal generator 106 can be transmitted to one or more electrodes 104, which can in turn deliver the signal to the target nerve and / or muscle structure. The electric field(s) generated by the current delivered by electrodes 104 produce the desired effect (e.g., excitation and / or inhibition) at the target nerve. In at least some embodiments, signal delivery device 100 need not include any onboard power storage elements (e.g., power capacitors and / or batteries) or any power storage elements with a storage capacity greater than 0.5 seconds, in order to reduce system size. In other embodiments, signal delivery device 100 may include one or more small charge storage devices (e.g., low-voltage, high-capacitance capacitors, solid-state batteries, and / or the like) that are compatible with the overall compact form factor of signal delivery device 100 and have a total charge storage capacity of no more than 1 second, 5 seconds, 10 seconds, 15 seconds, 20 seconds, 25 seconds, 30 seconds, 1 minute, 2 minutes, 5 minutes, any time period therebetween, or another suitable time period, depending on the embodiment. In at least some embodiments, the electrical signal delivered to the patient can be delivered via a dipole formed by two of electrodes 104. In other embodiments, the signal can be a unipolar signal in which at least a portion of the housing 102 (eg, the first end 102a of the housing 102) forms a ground or return electrode. In these and other embodiments, the waveform comprises a biphasic charge-balanced waveform.

[0055] In some embodiments, antenna 108 (or another communication component of signal delivery device 100) can be configured to wirelessly receive instructions and direct the instructions to signal generator 106 to generate an electrical signal, e.g., an electrical signal in addition to wirelessly receiving power. The instructions may include one or more signal delivery parameters of the electrical signal, such as frequency, amplitude, pulse width, duty cycle, duration, etc.; stimulation energy of the electrical signal; commands for delivering the electrical signal via individual electrodes in electrodes 104; an on-time during which the signal generator is active; an off-time during which the signal generator is inactive; and / or other suitable instructions. The instructions may be provided by the same device that wirelessly provides power to signal delivery device 100, or by another device (e.g., another external device, such as an external controller). Depending on the embodiment, the instructions may be carried by one or more computer- or machine-readable media contained in an implantable component, an external (e.g., wearable) component, or other controller, or any suitable combination of the foregoing. Additional details regarding devices for providing power and / or instructions to implanted signal delivery devices can be found in U.S. Patent Publication No. 2022 / 0161031, filed on February 7, 2022, entitled “IMPLANTABLE ELECTRODES WITH REMOTE POWER DELIVERY FOR TREATING SLEEP APNEA, AND ASSOCIATED SYSTEMS AND METHODS,” and U.S. Application No. 17 / 851,718, filed on June 28, 2022, entitled “WEABLE DEVICES FOR TREATING SLEEP APNEA, AND ASSOCIATED SYSTEMS AND METHODS,” the entire contents of which are incorporated herein by reference.

[0056] Figure 1B A partial schematic diagram of representative neural structures and musculature of a patient's upper airway. Figure 1C This is a lateral anatomy of the nerve structure and muscle tissue of the patient's upper airway. Figure 1B and 1C, representative muscle tissue includes the geniohyoid muscle GH and the genioglossus muscle GG, the genioglossus muscle GH extending between the patient's mandible M and hyoid bone HB, the genioglossus muscle GG including an oblique fiber portion GGo and a horizontal fiber portion GGh. Associated neural structures include at least a portion of one or both of the patient's hypoglossal nerves HGN that innervate the tongue, including the medial branch MB of the hypoglossal nerve HGN and / or one or more anterior portions or branches of the hypoglossal nerve HGN ("anterior branches AB"). The anterior branches AB may include distal dendritic portions of the hypoglossal nerve HGN, such as the motor point, motor endplate, and / or neuromuscular junction of the hypoglossal nerve HGN at its insertion into the genioglossus muscle GG. In some patients, one or more of the anterior branches AB may include multiple distal arm portions DB (in the medial branch MB) that innervate the genioglossus muscle GG. Figure 1D (More clearly visible in the figure). The lateral branch LB of the hypoglossal nerve HGN and the hyoglossus muscle HG are shown for context. By positioning and activating minimally invasive electrodes located near the aforementioned neural structures and / or associated muscle tissue, embodiments of the present technology can control, reduce, and / or eliminate the effects of OSA.

[0057] Figure 1D is a side view depicting a portion of a patient's upper airway and a signal delivery device 100 positioned in accordance with an embodiment of the present technology. Figure 1D In the embodiment, the signal delivery device 100 is positioned to deliver electrical signals to one or more of the anterior branches AB of the hypoglossal nerve HGN and / or one or more of the distal arm portions DB of the anterior branches AB. Figure 1D The hypoglossal nerve HGN of patient P shown in includes a total of three anterior branches AB and one anterior branch AB with two distal arm portions DB, but one skilled in the art will understand that other patients' hypoglossal nerves HGN may have more or fewer anterior branches AB, more or fewer anterior branches AB with distal arm portions DB, and / or more or fewer distal arm portions DB for each individual anterior branch AB. Additionally or alternatively, one or more other signal delivery devices may be positioned to deliver electrical signals to another portion of the hypoglossal nerve (such as the medial branch MB), another nerve (such as the C1 nerve), and / or positioned to deliver electrical signals directly to the genioglossus muscle GG. Reference will be made at least to Figures 2A-11 Additional details regarding the positioning of signal delivery devices are described.

[0058] 3. Representative insertion routes and signal delivery device locations

[0059] refer to Figure 2A-11 Several stimulation targets and implantation techniques are described and / or illustrated. For clarity of illustration, these stimulation targets and implantation techniques are illustrated with reference to the left or right side of the anatomy of patient P (e.g., the first portion of the left hypoglossal nerve of patient P). However, it should be understood that reference to Figure 2A-11At least some or all of the stimulation targets and / or implantation techniques described and / or illustrated are equally suitable for application to the other side of the patient's anatomy, for example, a second portion of the right hypoglossal nerve of patient P. In addition, at least some of the stimulation targets and / or implantation techniques can be used for bilateral signal delivery, for example, applying a first electrical signal to a first stimulation target on a first side of patient P at a first time, and applying a second electrical signal to a second stimulation target on a second side of patient P opposite to the first side at the same or different time. In some embodiments, the first stimulation target and the second stimulation target can be respective left and right portions of the patient's anatomy, such as a first portion of the left hypoglossal nerve and a second portion of the right hypoglossal nerve. In other embodiments, the first stimulation target and the second stimulation target can be different, such as a first portion of the patient's left hypoglossal nerve and a second portion of the genioglossus muscle.

[0060] Figure 2A is a side cross-sectional view of a portion of an upper airway of a patient depicting a signal delivery device 100 in a position at least proximate a target location in accordance with an embodiment of the present technology. In the illustrated embodiment, the target location includes one or more of the anterior branches AB of the hypoglossal nerve HGN. For example, the target location can be between about 10 mm and about 0.01 mm from one or more of the anterior branches AB, such as within a maximum of 9 mm, 8 mm, 7 mm, 6 mm, 5 mm, 4 mm, 3 mm, 2 mm, 1 mm, or 0.1 mm from one or more of the anterior branches AB, any distance therebetween, or another suitable distance from one or more of the anterior branches AB.

[0061] Some sleep apnea treatments involve stimulating the medial branch MB of the hypoglossal nerve HGN to elicit a protrusive response in the patient's tongue T. However, the medial branch MB may also innervate retractor muscle fibers, or "retractors" (e.g., the styloglossus and hyoglossus muscles), which, when activated, may elicit a retraction response that may equal or exceed the protrusive response. This retraction response can reduce or prevent effective sleep apnea treatment. In contrast to methods that target the medial branch MB of the hypoglossal nerve HGN, methods of the present technology may target one or more of the anterior branches AB of the hypoglossal nerve HGN. This approach is expected to reduce or prevent adverse stimulation, produce a net positive protrusive response (e.g., a protrusive response that is greater than the retraction response), and / or improve (e.g., increase) airflow through the patient's upper airway and / or oral cavity. In at least some embodiments, the patient's airflow can be improved without or substantially without producing a protrusive response in the patient's tongue and / or genioglossus muscle GG.

[0062] Without being bound by theory, delivering electrical signals to one or more of the anterior branches AB is expected to cause little stimulation to some or all of the retractor branches of the hypoglossal nerve HGN, at least because the anterior branches AB of the hypoglossal nerve HGN are anterior / downstream of the retractor branches. When the signal delivery device 100 is positioned to deliver electrical signals to one or more of the anterior branches AB, there can be a significant gap (e.g., about 1 cm or more) between the electrode 104 and the retractor muscles and / or the retractor branches of the hypoglossal nerve HGN. In these and other embodiments, the target location can include one or more other portions of the hypoglossal nerve HGN (e.g., the medial branch MB), the genioglossus muscle GG (e.g., the horizontal fiber portion GGh and / or the oblique fiber portion GGo), and / or another suitable tissue within the patient's mouth. As described in more detail below, applying electrical signals to the anterior limbs AB is expected to allow independent and / or selective control of which anterior limbs AB receive the electrical signals in order to, for example, (i) increase or maximize airflow through the patient's upper airway, (ii) reduce or minimize power consumption, (iii) contract a select subset of the genioglossus GG fibers, and / or (iv) improve patient comfort.

[0063] The signal delivery device 100 can be positioned at least proximate to a target location via an insertion path 210 that extends from a submental region SM of the patient P (such as from the underside of the patient's jaw J and / or between the patient's chin C and neck N) in an at least partially upward or superior direction toward the target location. The insertion path 210 can be used to position the signal delivery device 100 in an orientation such that at least a component of the orientation (e.g., a vector component) is aligned along an inferior-superior / craniocaudal axis. In other words, the signal delivery device 100 is not aligned solely along the x-axis. Rather, a vector component of the orientation (e.g., an effective vector component) is aligned along the y-axis. For example, as Figure 2A As shown, the first end 102a of the signal delivery device 100 is positioned above the second end 102b of the signal delivery device 100, such that the signal delivery device 100 and / or its electrodes 104 are positioned across or transverse to the main axis or body of one or more of the hypoglossal nerve HGN, the medial branch MB, and / or the anterior branch AB. When the signal delivery device 100 is in this orientation, one or more of the electrodes 104 can be positioned to deliver a signal to target tissue at or at least proximate to one or more of the anterior branches AB, which can induce protrusive movement of the patient's tongue T and / or otherwise improve airflow through the patient's airway and / or oral cavity.

[0064] Figure 2B is a side sectional view depicting a portion of the patient's mandible M and hyoid bone HB along the Figure 2A The implant orientation of the signal delivery device after insertion of the signal delivery device insertion path. Figure 2A and Figure 2B , when viewed in a direction perpendicular to the midsagittal or median plane of the patient P, the signal delivery device 100 may be positioned such that at least a portion of the signal delivery device 100 (e.g., Figure 2A The first end portion 102a and / or one or more of the electrodes 104 identified in FIG. 1 and FIG. 2 (a) is bisected and / or positioned between a first point or end at which each of the anterior branches AB innervates the genioglossus muscle GG (e.g., the oblique fiber portion GGo and / or the horizontal fiber portion GGh) and a second point or end at which each of the anterior branches AB diverges from the medial branch MB. The lateral branch LB of the hypoglossal nerve HGN is shown for background. This position / orientation of the signal delivery device 100 is expected to result in increased control over the patient's response to the electrical signal. For example, as Figure 2A As shown, one or more of the electrodes 104 of the signal delivery device 100 can be aligned transversely to the plurality of anterior branches AB. Thus, the electrodes 104 can be positioned to deliver electrical signals to at least two, three, four, or more of the anterior branches AB. Accordingly, the electric field EF generated between respective ones of the electrodes 104 can include field lines extending transversely, or at least substantially transversely, to one or more of the anterior branches AB.

[0065] In at least some embodiments, the signal delivery device 100 can be configured to selectively direct the electrical signal to one or more anterior branches, for example, to control which anterior branches AB (e.g., all or a subset) receive the electrical signal and / or which branch portions of each anterior branch AB receive the electrical signal. Such spatial control of the electrical signal is expected to allow the delivered signal to cause the various muscle compartments of the oblique fiber portion GGo and / or the horizontal fiber portion GGh of the genioglossus muscle GG to contract independently and / or selectively. This is described below with reference to Figures 5A-5E Detailed description. Additionally or alternatively, spatial control over the delivery of electrical signals is contemplated to allow the strength of the contraction of the genioglossus muscle GG to be adjustable, based at least in part on the number and / or location of the anterior branches AB and / or distal arms DB that receive the electrical signals. More specifically, when the oblique fiber portion GGo of the genioglossus muscle GG contracts, the contraction pulls the top / back portion of the tongue T near the palate inward toward the chin C. Additionally, the horizontal fiber portion GGh of the genioglossus muscle GG pulls the base of the tongue (e.g., near the hyoid bone HB) toward the chin C.

[0066] Embodiments of the present technology can independently and / or selectively deliver electrical signals to individual compartments of the muscle compartments in one (e.g., only one) or both of the oblique fiber portions GGo and / or the horizontal fiber portions GGh to cause contraction of the genioglossus muscle GG. This, in turn, is expected to provide patients with more precise or customizable treatment than delivering electrical signals to more posterior portions of the hypoglossal nerve, such as the medial branch. For example, because the medial branch MB innervates all of the anterior branches AB, delivering an electrical signal to the medial branch MB results in stimulation of all of the anterior branches AB (e.g., including any / all of their distal arm portions DB) and any / all muscles innervated thereby, including the oblique fiber portions GGo and the horizontal fiber portions GGh of the genioglossus muscle GG. As a result, when delivering electrical signals to the medial branch MB, it is difficult (if not impossible) to selectively activate the individual anterior branches AB, their distal arm portions DB, and / or the muscles innervated thereby. Additionally or alternatively, positioning the signal delivery device 100 in an inferior-superior orientation transverse to the hypoglossal nerve and / or one or more of its anterior branches AB is expected to allow the signal delivery device 100 to move at a rate and / or direction that is at least approximately similar or the same as the rate and / or direction of movement of the surrounding tissue. For example, in the inferior-superior orientation, the signal delivery device 100 can be transverse to the various muscle fibers of the genioglossus muscle GG, such that these muscle fibers "capture," reduce, or otherwise prevent the signal delivery device 100 from moving relative to these muscle fibers, and thereby move with these muscle fibers when these muscle fibers move (e.g., in response to stimulation, voluntary tongue movement, etc.). This can reduce, minimize, and / or prevent movement of the signal delivery device 100 relative to the target tissue, and can thereby improve the consistency of the patient's response to the electrical signal.

[0067] Reference again Figure 2A , the insertion path 210 may be linear or at least substantially linear, as Figure 2AAs shown. The at least substantially linear insertion path 210 is expected to increase the speed and / or accuracy with which the signal delivery device 100 can be positioned at least proximate to the target location (e.g., by a practitioner), for example, by minimizing or eliminating the need to reorient the signal delivery device 100 during insertion. In other embodiments, the insertion path 210 may include multiple insertion path segments or portions that are angled relative to one another. Each of the insertion path segments may be associated with a change in orientation of the signal delivery device 100 (e.g., by a practitioner during insertion). In at least some embodiments, each of the insertion path segments has a vector component aligned along an inferior-superior axis, which is expected to reduce or minimize changes in orientation of the signal delivery device 100 during insertion and increase the speed and / or accuracy with which the signal delivery device 100 can be positioned at least proximate to the target location. In other embodiments, one or more of the insertion path segments may have another suitable alignment. During insertion, the patient P may be at least partially sedated, unconscious, awake under local anesthesia, etc.

[0068] In at least some embodiments, an insertion point or opening 212 can be formed in the submental area SM, and the signal delivery device 100 can be passed through the opening 212 and moved along the insertion path 210. In the illustrated embodiment, the opening 212 is a percutaneous opening formed using a percutaneous or other minimally invasive insertion tool 214 (such as a needle (e.g., a percutaneous injection needle), a stylet, and / or a trocar) without performing dissection of the submental area SM. In some embodiments, all or a portion of the insertion tool 214 can be straight, curved at an angle (e.g., between about 60 degrees and about 75 degrees), spiral, or have another suitable shape or configuration. Additionally or alternatively, when the signal delivery device 100 is positioned at least proximate to the target location, the percutaneous insertion tool 214 can be used to position the signal delivery device 100 within the patient's body, for example, by protruding the signal delivery device 100 outward from within the percutaneous insertion tool 214 or otherwise releasing the signal delivery device 100 from the percutaneous insertion tool 214. In other embodiments, the opening 212 can be formed through the patient's chin C, jaw J, and / or mandible M, for example, using a drill or another suitable tool. In further embodiments, the opening 212 can be formed in one side of the patient's mouth, for example, through the patient's cheek, and the insertion tool 214 can then be inserted through the tongue T and / or another opening formed under the tongue in the patient's mouth. In some embodiments, forming the opening 212 through bone (such as in the jaw J and / or mandible M) is expected to increase the stability of the signal delivery device 100 (e.g., after implantation) and / or can allow for the use of a longer (e.g., wired) signal delivery device.

[0069] Figure 2AAlso schematically shown is a portion of a representative ultrasound probe 201 that can be used to assist in the process of identifying where to form an opening 212, identifying a target location, moving the signal delivery device 100 along the insertion path 210, and / or otherwise positioning the signal delivery device 100 at least proximate to the target location. The ultrasound probe 201 can include a linear ultrasound probe, a convex ultrasound probe, and / or one or more other suitable ultrasound probes, and can be configured to operate in A-mode, B-mode, motion or M-mode, one or more Doppler modes (e.g., pulsed wave, continuous wave, color, spectral, etc.), and / or one or more other modes. In at least some embodiments, the ultrasound probe 201 has an orientation that is at least substantially similar to or identical to the orientation of the signal delivery device 100 (e.g., at least a component of the ultrasound probe's orientation is aligned along an inferior-superior axis). Accordingly, the ultrasound probe 201 can be used to visualize the target location, the signal delivery device 100, and / or the percutaneous insertion tool 214 before, during, and / or after the procedure to position the signal delivery device 100 at least proximate to the target location. In such embodiments, aligning the orientation of the signal delivery device 100 and the ultrasound probe 201 is expected to increase the speed and / or accuracy of positioning the signal delivery device 100. In some embodiments, the orientation of the ultrasound probe 201 can be used to visualize / identify the hyoglossus muscle (HG) (retractor muscle), and accordingly, the user can avoid positioning the signal delivery device 100 near the HG, for example, to further reduce or prevent retraction of the patient's tongue. In these and other embodiments, the ultrasound probe 201 can be used to position the signal delivery device 100 at or near the target location, and the signal delivery device 100 can deliver electrical signals during all or part of the implantation process, allowing the practitioner to observe the patient's response to the electrical signals, for example, to confirm that the signal delivery device 100 is at or near the target location and / or to inform further adjustments to the positioning of the signal delivery device 100. This is described in more detail in previously incorporated herein by reference U.S. Patent Publication No. 2022 / 0161031 and U.S. Application No. 18 / 104,739, the entire contents of which are incorporated herein by reference.

[0070] Figure 2C and 2D The submental and coronal cross-sections depict at least Figure 2A The signal delivery device 100 at the target location. Figure 2C and Figure 2D As best shown in FIG, at least a portion of the signal delivery device 100 (e.g., one or more of the electrodes 104; Figure 2CThe signal delivery device 100 may be positioned lateral to the genioglossus GG (e.g., the patient's left genioglossus) and / or inferior to / under the hyoglossus HG (e.g., the patient's left hyoglossus). As discussed above, this procedure may be performed without penetrating into the genioglossus GG and / or hyoglossus HG. In other embodiments, all or a portion of the signal delivery device 100 may be positioned within the genioglossus GG, such as medially from one or more of the lateral branches AB, as described below with reference to 7A to 9B As stated.

[0071] refer to Figure 2D In the illustrated embodiment, the insertion point 212 is spaced apart and / or positioned lateral to the mid-sagittal plane of the patient P. In other embodiments, the insertion point 212 may be coplanar with the sagittal plane.

[0072] Figures 3A-3C is a side cross-sectional view of a portion of a patient's upper airway depicting corresponding signal delivery device insertion paths, each in accordance with an embodiment of the present technology. Figure 3A The angular range 316 of an approach path for inserting a signal delivery device at one or more points along the anterior-posterior axis (x-axis) is shown. For a given target location, the mandible M and / or chin C can at least partially define the most anterior limit of the range of the insertion path 316, and the hyoid bone HB and / or neck N can at least partially define the most posterior limit of the range of the insertion path 316. In some embodiments, the preferred insertion path bisects the range of the insertion path 316, or is within any angle of plus or minus 20 degrees, 15 degrees, 10 degrees, 5 degrees, 1 degree, or another suitable angle that bisects the insertion path.

[0073] The insertion openings associated with each of the range of insertion paths 316 may affect the relative orientation of the signal delivery device 100. For example, referring to Figure 3B , the first insertion path 310a can be used to position the signal delivery device 100 at least proximal to one or more of the anterior ramus AB and can include a first opening 312a formed near / posterior to the mandible M and / or chin C and distal / anterior to the hyoid bone HB and / or neck N. Due to the relatively anterior position of the first opening 312a, the first end 102a of the signal delivery device 100 can be positioned superiorly and posteriorly relative to the second end 102b. Accordingly, the signal delivery device 100 can be advanced along the first insertion path 310a in a direction at least partially from anterior to posterior, e.g., along a path having a vector component aligned with the anterior to posterior direction.

[0074] As another example, refer to Figure 3C The second insertion path 310b can be used to position the signal delivery device 100 at least proximate to one or more of the anterior branches AB and can include more Figure 3B The second opening 312b is positioned further posteriorly than the first opening 312a of the signal delivery device 100 such that the first end 102a of the signal delivery device 100 is superior and anterior relative to the second end 102b. In at least some embodiments, the patient's head can be rotated posteriorly before and / or during formation of the second opening 312b to at least partially or completely prevent the neck N from obstructing access to the submandibular region SM. For example, the user can move (e.g., rotate) the patient's head posteriorly, posteriorly and leftwardly, or posteriorly and rightwardly to expose the second opening 312b and / or one or more other submandibular insertion points. In at least some embodiments, this can include overextending the patient's neck to expose the insertion point, for example, based at least in part on the length of a percutaneous injection needle or other device used during the procedure. Once the second opening 312b or other insertion point is exposed, the signal delivery device 100 can be advanced along the second insertion path 310b in a direction at least partially from posterior to anterior, for example, along a path having a vector component aligned with the direction from posterior to anterior (e.g., the x-axis, as in FIG. 2 ). Figure 3C shown).

[0075] Figures 4A-4C is a coronal cross-sectional view of a portion of a patient's upper airway depicting respective signal delivery device insertion pathways according to embodiments of the present technology. Figure 4A The range of insertion paths 418 that vary in the medial-lateral direction is shown. For a given target location and / or tissue, the left mandibular portion M L and right mandibular part M R The lateral boundaries of the extent of the insertion path 418 may be at least partially defined. In some embodiments, the preferred insertion path bisects the patient's midline and the portion of the mandible closest to the target anatomical location. L 、M R The insertion path 418 may be within the range of 20 degrees, 15 degrees, 10 degrees, 5 degrees, 1 degree, or another suitable angle that bisects the insertion path. The insertion path may be angled in the anterior-posterior direction (e.g., entering and exiting the insertion path). Figure 4A ), to avoid puncturing sensitive areas, such as the patient's salivary gland SG. In these and / or other embodiments, the insertion path can be angled to puncture the patient's mylohyoid muscle MH while avoiding, or at least substantially avoiding, puncturing / penetrating one or more other muscles in the patient's neck and / or jaw. Although the insertion path can pass through the mylohyoid muscle MH, the signal delivery device and / or one or more electrodes thereof can be unaffected by the mylohyoid muscle MH after implantation (e.g., not permanently embedded within the mylohyoid muscle MH).

[0076] The openings associated with each of the insertion paths within the range of insertion paths 418 may affect the relative orientation of the signal delivery device 100. For example, referring to Figure 4B The first insertion path 410a can be used to position the signal delivery device 100 at least proximal to one or more of the anterior branches AB and can include the left mandibular portion M. L and right mandibular part M R 1 . A first opening 412a is formed approximately centrally between the first and second ends 102b of the signal delivery device 100. Due to the central location of the first opening 412a, the first end 102a of the signal delivery device 100 is positioned above and outboard relative to the second end 102b. Accordingly, the signal delivery device 100 can be advanced along the first insertion path 410a in a direction at least partially from inside to outside, e.g., along a path having a vector component aligned with the direction from inside to outside.

[0077] As another example, refer to Figure 4C The second insertion path 410b can be used to position the signal delivery device 100 at least proximal to one or more of the anterior branches AB and can include proximal to the left mandibular portion M. L The second opening 412b is formed. Due to the relatively outboard position of the second opening 412b, the first end 102a of the signal delivery device 100 is positioned above and inboard relative to the second end 102b. Accordingly, the signal delivery device 100 can be advanced along the second insertion path 410b in a direction at least partially from the outside to the inside, e.g., along a path having a vector component aligned with the direction from the outside to the inside.

[0078] Figures 2A to 4C The insertion path of the signal delivery device 100 is generally described with reference to positioning the signal delivery device 100 at least proximate to the anterior branch AB of the hypoglossal nerve HGN. In other embodiments, any of the insertion paths described herein (or at least one or more portions thereof) can be used to position the signal delivery device 100 at least proximate to one or more other target locations, such as at least proximate to the medial branch MB of the hypoglossal nerve HGN and / or the genioglossus muscle GG of the patient. In addition, below with reference to Figures 7A-9B Additional embodiments associated with the genioglossus muscle GG are described.

[0079] Typically, electrical signals applied to nerves (including the hypoglossal nerve (HGN)) have a characteristic neuromuscular activation threshold (e.g., minimum amplitude) associated with eliciting an evoked motor response in the patient's tissue innervated by the nerve. Often, little or no motor response is evoked before the neuromuscular activation threshold is met. After the neuromuscular activation threshold is met or exceeded, further changes to the electrical signal (e.g., further increases in delivered energy) often produce little additional motor response, making it difficult to gradually induce a motor response over time. One approach to addressing this problem is to deliver electrical signals to one or more of the anterior branches AB of the hypoglossal nerve (HGN), as previously described with reference to Figures 2A-4C Each of the distal arm portions DB innervates one or more specific muscle fibers of the genioglossus muscle GG. For example, as shown in a side view of a patient's tongue and upper airway Figure 5A Each of the distal arm portions DB of the hypoglossal nerve HGN is shown innervating a specific portion or muscle compartment GGo1-GGo4, GGh1, GGh2 of the patient's genioglossus muscle GG. In the illustrated embodiment, the portion includes four oblique fiber compartments GGo1-GGo4 and two horizontal fiber compartments GGh1, GGh2 of the genioglossus muscle GG. In other embodiments and / or for other patients, the genioglossus muscle GG may include more or fewer muscle compartments, and / or each compartment may have a larger or smaller size. Each of the compartments GGo1-GGo4, GGh1, GGh2 may include a corresponding surface portion T1-T6 of the patient's tongue T. Prior to delivery of the electrical signal, the tongue T has a first, or unstimulated, geometry or profile 530. When each of the genioglossus compartments GGo1-GGo4, GGh1, GGh2 contracts (e.g., in response to an electrical signal from a signal delivery device), the contraction can cause corresponding surface portions T1-T6 of the patient's tongue T to displace inwardly toward the mandible M. This, in turn, can increase airflow through the patient's oral cavity OC, e.g., by reducing or even preventing obstruction in the posterior palate portion RP and / or posterior lingual portion RL of the patient's oral cavity OC, and / or reducing or even preventing pressure of the tongue T against the patient's soft palate. The patient's mandible M, hyoid bone HB, and genioglossus muscle GH are shown for context.

[0080] The electrical signal is delivered to the hypoglossal nerve HGN at a location posterior to the anterior branch AB, e.g. Figure 5B, a motor response is expected to be generated throughout the patient's tongue T, e.g., in each (e.g., all) of the compartments GGo1-GGo4, GGh1, GGh2 of the genioglossus GG, and to cause corresponding movement of each of the surface portions T1-T6 of the patient's tongue T from a first geometry 530 to a second or contracted geometry or profile 532. However, the arm-like nature of the anterior branch AB and distal arm portion DB allows for geographic segregation of current density to selectively target some subset of the distal arm portion DB, and by extension, a corresponding subset of the genioglossus GG compartments. The response from the targeted anterior branch AB fibers is expected to be binary (e.g., a signal delivered to each anterior branch AB will either produce a motor response or not), but the signal can be delivered such that a subset of the anterior branch AB can receive the electrical signal and cause a corresponding subset of the genioglossus GG compartments to contract and, by extension, cause movement of a portion of the patient's tongue. This is discussed below with reference to Figures 5C to 6C Describe in more detail.

[0081] Figure 5C shows a process at least substantially similar to that of the previous reference Figure 3C In other embodiments, the signal delivery device 100 may be positioned and / or oriented as described above. Figures 2A-2D , 3A, 3B, and / or 4A-4C. The spacing between each of the electrodes 104 can be at least substantially similar to or identical to the spacing between its anterior branches AB and / or distal arm portions DB, such that each of the electrodes 104 can be positioned at least proximal to (and / or otherwise positioned to deliver electrical signals to) each of the distal arm portions DB. In the illustrated embodiment, for example, the second and third electrodes 104b, 104c of the signal delivery device 100 are positioned to deliver electrical signals to the distal arm portions DB innervating the second and third compartments GGo2 and GGo3 of the genioglossus muscle GG, and to induce motor responses in these portions. Accordingly, activation of the second and third electrodes 104b, 104c can generate an electric field that delivers electrical signals to the distal arm portions DB innervating the second and third compartments GGo2 and GGo3 of the genioglossus muscle GG, and to induce motor responses in these portions. This, in turn, may cause corresponding movement of the second and third surface portions T2, T3 of the patient's tongue T, e.g., from a first geometric shape 530 to a third or constricted geometric shape or profile 534 (different from, e.g., Figure 5B, and / or the second geometry 532 of the patient's tongue). Such tongue movement can increase airflow through the posterior palate portion RP of the patient's oral cavity OC, for example, by reducing or preventing pressure of the tongue on the patient's soft palate, without changing or substantially changing the geometry of the posterior tongue portion RL of the patient's oral cavity OC. In some cases, the movement response of the second and third compartments GGo2, GGo3 and / or the second and third surface portions T2, T3 can cause other and / or unstimulated portions of the genioglossus muscle GG to move. For example, the first compartment GGo1, the fourth compartment GGo4 and / or the corresponding surface portions of the patient's tongue (e.g., the first surface portion T1, the fourth surface portion T4) can move in response to the movement of the second and third compartments GGo2, GGo3 and / or the second and third surface portions T2, T3, as shown in FIG. Figure 5C The responses of these other and / or unstimulated portions are expected to have smaller amplitudes than the responses of the portion of the genioglossus muscle GG that receives the electrical signal, in whole or in part due to the close and / or adjacent location of the other unstimulated portions and the target portion.

[0082] exist Figure 5C In the embodiment shown, the signal delivery device 100 is positioned to deliver electrical signals to the left hypoglossal nerve HGN. Accordingly, all or at least a portion of the left side of the patient's tongue T is expected to be as Figure 5C The signal delivery device is positioned bilaterally (e.g., to stimulate the left and right hypoglossal nerves of the patient) so that both the left and right sides of the patient's tongue T are moved as shown. Figure 5C Move as shown.

[0083] although Figure 5C The movement of a portion of the patient's tongue T in the sagittal (e.g., xy) plane is shown, but one skilled in the art will appreciate that the tongue T can move in other directions. For example, because the tongue T is a muscular hydrostatic bone and maintains a constant (or at least approximately constant) volume during movement, Figure 5C Contraction of the tongue as shown in is contemplated to cause a corresponding expansion of the tongue T in a direction at least generally parallel to the z-axis (eg, a lateral expansion).

[0084] Figure 5D Shows the Figure 5C The signal delivery device 100 is similarly positioned and / or oriented as shown in FIG, but with a different combination of activated electrodes. More specifically, in FIG. Figure 5DIn the embodiment of the present invention, the third electrode 104c and the fourth electrode 104d of the signal delivery device 100 are activated to deliver electrical signals to the distal arm portion DB of the fourth compartment GGo4 and the horizontal fiber compartments GGh1 and GGh2 of the genioglossus muscle GG. This, in turn, can cause the fourth, fifth, and sixth surface portions T4, T5, T6 of the patient's tongue T to contract from the first geometric shape 530 to a fourth contracted or undulating geometric shape 536 (different from, for example, Figure 5B The second geometric shape 532 and / or Figure 5C ), thereby increasing the airflow through the posterior lingual portion RL of the patient's oral cavity OC without changing or substantially changing the geometry of the posterior palate portion RP of the patient's oral cavity OC.

[0085] Figure 5E Shows the Figure 5C The signal delivery device 100 is similarly positioned and / or oriented as shown in FIG, but with a different combination of activated electrodes. More specifically, in FIG. Figure 5E , the first electrode 104a and the fourth electrode 104d of the signal delivery device 100 are activated to deliver electrical signals to the distal arm portion DB of each of the compartments GGo1-GGo4, GGh1, GGh2 that innervate the genioglossus muscle GG. This, in turn, causes the tongue to contract from the first geometric shape 530 to a fifth geometric shape or profile 538 that is at least substantially similar to or identical to the second geometric shape 532 ( Figure 5B ). In other embodiments, additional (or all) electrodes of the signal delivery device 100 may be activated to move the tongue T to the second geometric shape 532. Thus, Figure 5E As shown in the position, the signal delivery device 100 can generate Figure 5B The same or at least substantially similar motor response as in the embodiment of Figure 5B In the embodiment of FIG. 1 , the signal delivery device 100 is positioned to stimulate the posterior portion of the hypoglossal nerve HGN. Figure 5E The signal delivery device 100 can generate different or smaller motor responses by selectively activating different electrode combinations, as previously described with reference to FIG. Figure 5C and 5D As described. Accordingly, the delivery methods of the present technology and / or the position and / or orientation of the signal delivery devices described herein can provide an array of graded patient responses by selectively increasing or decreasing the number of anterior branches AB that receive electrical signals. In at least some embodiments, for example, individual distal arm portions DB can be stimulated sequentially to establish a complete patient response (e.g., anterior protrusive response, airflow improvement, etc.) over time in a manner that is impossible or very difficult to achieve by activating more posterior portions of the hypoglossal nerve (e.g., medial branch MB).

[0086] In some embodiments, the patient's airway and / or tissue collapse pattern (e.g., anterior-posterior, lateral, annular / circumferential, etc.) can be identified, and individual distal arm portions in the distal arm portions DB can be stimulated to change the geometry of a corresponding portion of the patient's tongue T, for example, to reduce or prevent tissue collapse at that portion and / or other portions of the patient's tongue T and / or change the geometry of other portions of the patient's airway (e.g., to prevent the patient's tongue from pressing on the soft palate, reduce the pressure of the patient's tongue against the soft palate, move the patient's epiglottis forward, etc.). This, in turn, can allow only the portion of the patient's tongue and / or other tissue that caused the obstruction event to move, without moving, or at least substantially moving, other tissue / tissue portions. The present invention may be used with at least reference to Figure 19 Tissue collapse patterns are identified by one or more sensors as described and / or via X-ray, CT scanning, fluoroscopic imaging, ultrasound imaging, direct visualization (eg, via endoscopic imaging), stimulus pulse response, and / or other suitable identification techniques.

[0087] Figures 6A-6C is a side cross-sectional view of a patient's oral cavity and upper airway and depicts a representative tongue collapse pattern that can be addressed by techniques according to embodiments of the present technology. More specifically, Figure 6A The upper tongue collapse in the retropalatal portion RP of the patient's airway is shown, wherein the tongue T is pressed against the patient's soft palate (e.g., shown using dashed lines). To address the upper tongue collapse, an electrical signal may be applied to one or more muscle compartments of the genioglossus muscle, at least substantially as previously described with reference to FIG. Figure 5C Similar or identical to those described, for example, to reduce or prevent the tongue T from pressing against the soft palate SP and / or otherwise increase airflow through the retropalatal portion RP of the patient's airway.

[0088] Figure 6B FIG. 1 shows a patient with lower tongue collapse in the posterior lingual portion RL of the airway. To address lower tongue collapse, electrical signals may be applied to one or more muscle compartments of the genioglossus muscle, at least approximately as described previously with reference to FIG. Figure 5D Said similarity or identity may, for example, be used to increase airflow through the retrolingual portion RL of the patient's airway.

[0089] Figure 6C Combined (e.g., complete) tongue collapse in both the posterior palate portion RP and the posterior lingual portion RL of the patient's airway is shown. To address lower tongue collapse, electrical signals may be applied to one or more muscle compartments of the genioglossus muscle, at least substantially as previously described with reference to FIG. Figure 5E Said similarity or identity may, for example, be used to increase airflow through the retro-palatal portion RP and retro-lingual portion RL of the patient's airway.

[0090] For reference Figures 5C-6CSelectively delivering electrical signals to individual distal arm portions DB of the anterior limb AB is expected to improve patient comfort and / or patient compliance with treatment, for example, by reducing the amount and / or energy of stimulation delivered and / or minimizing induced tongue movement to address the patient's sleep apnea. This can, for example, reduce or prevent tongue wear associated with movement of the tongue that drives the anterior portion of the patient's tongue against the patient's teeth (e.g., tongue protrusion forward and / or protrusion from the patient's mouth) and / or otherwise reduce patient arousal during treatment (e.g., by reducing or preventing unpleasant and / or uncomfortable sensations associated with electrical signals that cause the entire tongue T to contract / protrude, such as cramps, buzzing, and / or tongue twitching). Additionally or alternatively, reducing the delivered stimulation energy can reduce power consumption of the signal delivery device and / or improve battery life of the signal delivery device and / or external power source.

[0091] Another approach is to apply electrical signals directly to the muscle(s) associated with the motor response of interest. For example, applying an electrical signal directly to one or both of a patient's genioglossus muscles (GG) would activate the same muscles as applying an electrical signal to one or more of the anterior branches AB of the hypoglossal nerve (HGN), but additionally allows for a more gradual dose-response activation by recruiting terminal nerve / muscle fibers (e.g., compared to activating nerves / nerve branches innervating the genioglossus muscles (GG)). For example, applying a first electrical signal having one or more first signal delivery parameters (e.g., amplitude, frequency, pulse width, etc.) to the genioglossus muscles (GG) at a first time can elicit a first motor response, and applying a second electrical signal having one or more second signal delivery parameters different from the one or more first signal delivery parameters to the genioglossus muscles (GG) at a second time can elicit a second motor response having a different (e.g., greater or lesser) degree, range, and / or amount of motion than the first motor response. In some embodiments, the first signal delivery parameters can include a first amplitude, and the second signal delivery parameters can include a second amplitude greater than the first amplitude, such that delivery of the second electrical signal is expected to produce a greater motor response than delivery of the first electrical signal. Thus, applying electrical signals directly to the genioglossus muscle(s) GG is expected to provide an improved ability to modulate tongue motor responses by increasing control over the evoked patient motor responses and / or the rate of genioglossus muscle GG contraction.

[0092] The aforementioned increased control over induced patient motor responses can improve the ability to reduce and / or prevent airway obstruction and / or improve patient comfort and / or treatment compliance. Additionally or alternatively, applying an electrical signal directly to the genioglossus muscle(s) GG is expected to reduce or prevent activation of retraction, at least because the genioglossus muscle GG is "downstream" of the anterior branch AB and is therefore positioned at least the same distance from the retraction branch of the hypoglossal nerve HGN as the anterior branch AB and / or more anteriorly. This, in turn, is expected to reduce or prevent electrical signals from being delivered to the retraction branches and / or retraction muscle fibers (e.g., the genioglossus and / or hyoglossus muscles). Additionally or alternatively, delivering an electrical signal to the genioglossus muscle GG causes the tongue T to protrude, which is expected to reduce or prevent retraction movements of the tongue and / or produce a net positive protrusive response. In these and other embodiments, implanting the signal delivery device 100 to deliver electrical signals to the genioglossus muscle GG is expected to increase the speed and / or accuracy with which the signal delivery device 100 can be positioned (e.g., by a practitioner) at least proximate to a target location, e.g., by minimizing or eliminating the need to reorient the signal delivery device 100 during insertion, as previously described with reference to Figures 2A-2C In addition, because the genioglossus GG is larger than the nerve that innervates it, the genioglossus GG is expected to be easier to identify (e.g., using Figure 2A Without being bound by theory, the genioglossus muscle GG's response to directly delivered electrical signals is believed to be less sensitive or insensitive to the location of the signal delivery device within the genioglossus muscle GG. Accordingly, the genioglossus muscle GG may define a larger area (e.g., compared to a nerve) within which the signal delivery device 100 may be positioned, which is expected to reduce the time associated with identifying and / or implanting the signal delivery device 100.

[0093] Figure 7A and 7B are side and submental cross-sectional views, respectively, depicting a signal delivery device insertion path configured according to an embodiment of the present technology. Figure 7A , the signal delivery device 100 may have a front-to-back position that is similar to the previous reference Figure 2A The front-to-back positions of the signal delivery devices 100 described are at least generally similar or identical. Figure 7B , all or a portion of the signal delivery device 100 may be positioned in one of the genioglossus muscles GG of the patient P (eg, the left genioglossus muscle GG L or right genioglossus GG R ). For example, all or at least a portion of the electrodes 104 carried by the signal delivery device 100 can be positioned within the genioglossus muscle GG. In the illustrated embodiment, the signal delivery device 100 is positioned within the patient's left genioglossus muscle GG. L In these and other embodiments, the left genioglossus GG L and right genioglossus GGR Both may have one or more of the signal delivery devices 100 positioned therein. In a further embodiment, the signal delivery device 100 may be directed from the patient's right genioglossus muscle GG R or left genioglossus GG L Laterally positioned, and / or the first signal delivery device may be directed from the right genioglossus GG R Laterally positioned, and the second signal delivery device can be from the left genioglossus GG L Lateral positioning.

[0094] Figure 8A and 8B are side and submental cross-sectional views, respectively, depicting a signal delivery device insertion path configured according to an embodiment of the present technology. Figure 8A , the front-to-back positioning of the signal delivery device 100 can be compared with the previous reference Figure 2A The front-to-back positioning of the signal delivery device 100 described is at least generally similar or identical. Figure 8B , all or a portion of the signal delivery device 100 may be positioned in the left genioglossus muscle GG L and right genioglossus GG R In this position, the signal delivery device 100 can deliver signals to the left genioglossus muscle GG L and right genioglossus GG R One or both of .

[0095] Figure 9A and 9B The following are side and submental cross-sectional views respectively, depicting the insertion path of the signal delivery device configured according to an embodiment of the present technology. Figure 9A and 9B , the signal delivery device 100 can be positioned at the left genioglossus muscle GG L and right genioglossus GG R between, and positioned at least approximately similar to Figure 8A and 8B However, in Figure 9A and 9B In, with Figure 7A and 7B The signal delivery device 100 is positioned more forward than in the position in FIG. Figures 3A-3C The patient's mandible M and / or chin C ( Figure 9A ) may define the anteriormost boundary of the positioning and / or insertion path of the signal delivery device 100, and the patient's hyoid bone HB and / or neck N ( Figure 9A ) may define the final boundary of the location of the signal delivery device 100. As previously referenced Figures 4A-4C The left mandibular portion M of the patient's mandible ML and right mandibular part M R The lateral boundaries of the positioning and / or insertion path of the signal delivery device 100 may be defined.

[0096] Figure 10 is a side view depicting another signal delivery device insertion path 1010 oriented in accordance with an embodiment of the present technology. Figure 10 As shown, the signal delivery device 100 can be positioned to stimulate the medial branch MB or another portion of the hypoglossal nerve HGN via an insertion point 1012 formed in the submental region SM of the patient P. As previously described herein, the insertion path 1010 can be at least generally linear or can include one or more insertion path segments that can be angled relative to each other. The insertion path 1010 can be used to advance the signal delivery device 100 anteriorly, posteriorly, medially, laterally, and / or combinations thereof.

[0097] Figure 11 is a side view depicting another signal delivery device insertion path 1110 oriented in accordance with an embodiment of the present technology. Figure 11 As shown, the signal delivery device 100 can be inserted into the patient P through the patient's oral cavity OC, such as through a sublingual opening 1112 formed in the floor of the patient's mouth. In the illustrated embodiment, the signal delivery device 100 is positioned to deliver electrical signals to the medial branch MB of the patient's hypoglossal nerve HGN. In other embodiments, the signal delivery device 100 can be inserted through the sublingual opening 1112 and positioned to deliver electrical signals to one or more of the anterior branches AB, another portion of the hypoglossal nerve HGN, at least partially positioned with the patient's genioglossus muscle GG, and / or at another suitable location. As previously described herein, the insertion path 1110 can be at least generally linear, or can include one or more insertion path segments that can be angled relative to each other. The insertion path 1110 can be used to advance the signal delivery device 100 forward, backward, medially, laterally, and / or combinations thereof.

[0098] 4. Representative experimental data

[0099] Figure 12 Graphs showing patient data obtained by directing electrical signals to target tissue according to embodiments of the present technology. For example, Figure 12 The stimulation graph 1220 shows the stimulation versus time ("Stimulation Graph 1220") and the patient airflow versus time ("Airflow Graph 1222"). The stimulation graph 1220 shows the stimulation versus time from the signal delivery device (e.g., Figure 1A The electrical signal 1224 is delivered to the patient by a signal delivery device 100 of the present invention, the signal delivery device being at least substantially similar to or identical to the Figure 2AOther positions / orientations described herein (including reference Figures 3A-8B those described) are expected to provide Figure 12 Results are at least substantially similar or identical to those shown.

[0100] The data in airflow graph 1222 was obtained using drug-induced sleep endoscopy (DISE), a dynamic assessment technique used to examine an individual's upper airway obstruction pattern. For example, DISE can provide information regarding one or more areas of collapse during sleep and / or one or more specific structures and / or tissues contributing to such obstruction (including the lateral pharyngeal walls, soft palate, tongue, and / or epiglottis). DISE is typically performed after a patient has been administered a sedative (e.g., propofol or midazolam). Sedatives can cause airflow limitation / obstruction in the patient's airway, mimicking obstructive sleep apnea (OSA), or other apneic and / or hypopneic events. For example, administering propofol to a patient can induce pharyngeal muscle relaxation (a decrease in muscle tone), leading to collapse of the patient's airway. This is illustrated, for example, in the pre-signal delivery portion 1228a and post-signal delivery portion 1228c of airflow curve 1222, during which airflow curve 1222 indicates that the patient experienced completely obstructed airflow (e.g., OSA or an apneic event). However, during signal delivery period 1226 when electrical signal 1224 is delivered to the patient, corresponding signal delivery portion 1228b of airflow graph 1222 indicates that airflow limitation is at least partially reduced or eliminated and / or airflow to the patient is at least partially or fully restored.

[0101] Figure 13 is a table including data obtained by implanting and activating a signal delivery device according to an embodiment of the present technology. Figures 2A-8B The signal delivery device was received using one or more of the approaches described herein that are at least substantially similar or identical. Subjects 1-9 each received a signal delivery device using an anterior to posterior delivery approach, such as Figure 11 The Electrode Array Capture and Stability During Surgery column indicates the electrode array (e.g. Figure 1A The signal delivery device 100) remains positioned to deliver the electrical signal to the target tissue. The electrode array used in this study does not include anchors or other components that attach to the patient's tissue and is accordingly intended for short-term stimulation rather than long-term stimulation. Figure 13As shown, the approach of the present technology used with subjects 10-13 was able to position the signal delivery device with at least five times greater stability than the approach used for subjects 1-9. Accordingly, implanting the device using an anterior approach is expected to provide more time for the device to be anchored and / or the device may include a less bulky and / or lower profile anchoring component compared to devices implanted using a posterior approach or other approaches. In addition, as shown by the data in the Peak Flow Amplitude Increase Stimulation / No Stimulation column, the approach of the present technology used for subjects 10-13 was at least as effective (if not more effective) in increasing patient airflow and / or otherwise reducing / eliminating airflow restriction / obstruction. The entry "N / A" indicates a patient with CCC and for whom no airflow measurements were obtained.

[0102] Figure 14 Graphs illustrating patient data obtained by directing electrical signals to the distal branches of the patient's hypoglossal nerve according to several embodiments of the present technology. Specifically, Figure 14 Included are graphs of pressure 1430, airflow 1422, epiglottal pressure 1432, and jaw EMG 1434 signals during a pre-signal delivery period 1428a, a signal delivery period 1426, and a post-signal delivery period 1428b. Figure 14 The data presented in Figure 12 and 13 The data shown in the figure were obtained later.

[0103] During signal delivery period 1426, electrical signals are directed from an electrode array positioned in accordance with embodiments of the present technology to one or more anterior branches of the hypoglossal nerve. To obtain this data, the patient is equipped with an electroencephalogram, an electrooculogram, a submental chin electromyogram, an epiglottal pressure sensor, and a sealed nasal mask and pneumotachometer to quantify airflow. Following propofol sedation, ultrasound is used to identify the distal branches of the patient's hypoglossal nerve to guide placement of a transcutaneous electrode array as previously described herein, for example, at a site at least approximately similar to Figure 3C The embodiment is positioned and / or oriented as shown. An endoscope is inserted through the patient's nose to visualize changes in the size and shape of the patient's airway while electrical signals are delivered to the distal branches via the electrode array. A modified CPAP device is used to deliver therapeutic CPAP and a transient pressure reduction to induce airflow limitation / closure. A CPAP reduction is delivered for at least 9 breaths, with stimulation applied during a subset of those breaths.

[0104] Before the start of pre-signal delivery period 1428a, pressure graph 1430 shows a higher pressure level, and airflow graph 1422 shows the airflow pattern of normal breathing. At the start of pre-signal delivery period 1428a, pressure graph 1430 shows a rapid decrease in pressure, designed to produce the onset of an apneic event, during which the subject's breathing is obstructed, and airflow graph 1422 shows the patient's breathing being obstructed. As described above, obstruction is simulated by lowering pressure within the patient's airway using a modified CPAP device, causing the patient's airway tissue to collapse in a manner that simulates the symptoms experienced during an obstructive sleep apnea (OSA) event. Notably, during signal delivery period 1426, airflow graph 1422 shows that the patient's airflow has fully recovered and the patient is able to breathe normally, or at least substantially normally. This is further confirmed by epiglottal pressure graph 1432, which shows rapid pressure fluctuations during pre-signal delivery period 1428a and post-signal delivery period 1428b, indicating obstructed breathing, but shows stable changes during signal delivery period 1426, indicating the patient's airflow has fully recovered and returned to normal breathing. Delivery of electrical signals from an electrode array positioned according to embodiments of the present technology to one or more anterior branches of the hypoglossal nerve correspondingly elicited a motor response from the patient (e.g., forward movement of at least a surface portion of the patient's tongue) to restore airflow. Changes in jaw EMG graph 1434 during signal delivery period 1426 confirmed that the electrical signals produced a motor response in the patient. During post-signal delivery period 1428b, the subject returned to an apneic state until after post-signal delivery period 1428b, at which point the simulated apneic event ended and the subject returned to normal breathing.

[0105] Figure 15 is a graph of airflow data for ten patients who received electrical signals delivered according to embodiments of the present technology. Specifically, each line shows the change in airflow before delivery of the electrical signal (e.g., "stimulation off") and during delivery of the electrical signal (e.g., "stimulation on"), averaged over three breaths for an individual patient. Figure 15 The data presented in Figure 12 and 13 The data shown in the figure were obtained later.

[0106] like Figure 15 As shown, delivering the electrical signal produced an increase in airflow for each patient. For some patients, the electrical signal restored airflow to a level associated with the absence of sleep apnea or other normal breathing (e.g., "no OSA"). For example, referring to the patient indicated by line 1500 (obtained Figure 14), delivering an electrical signal according to an embodiment of the present technology not only restored that patient's airflow from a level associated with apnea, specifically a near complete cessation of airflow (i.e., a breath with almost complete obstruction), to a level associated with normal breathing, but also produced an increase in airflow of approximately 2000%. Figure 15 Other patients experienced similar degrees and / or magnitudes of increased airflow as shown. These results exceeded the inventors' expectations, and the inventors are currently unaware of any other electrical stimulation-based therapy that has been demonstrated to provide Figure 15 A sleep apnea treatment system or method that increases airflow to the extent or magnitude indicated.

[0107] 5. Additional Devices, Systems, and Methods

[0108] Figure 16is a cross-sectional side view of a portion of a patient's upper airway depicting an insertion guide 1600 configured in accordance with an embodiment of the present technology. The insertion guide 1600 may include a body or support structure 1602 and one or more alignment features 1604 (individually identified as a first alignment feature 1604a, a second alignment feature 1604b, a third alignment feature 1604c, and a fourth alignment feature 1604d). The support structure 1602 may be positioned on / above at least a portion of the patient's submental region SM and / or may be configured to conform to (e.g., elastically deform to) at least a portion of the patient's submental region SM. The support structure 1602 may be customized to the patient's specific anatomy and / or may be adjustable to fit a range of patient anatomy. In some embodiments, the support structure 1602 may be coupled and / or secured to the patient P, for example, via an adhesive, one or more straps, a collar, and / or a neck brace, or the like. In other embodiments, the support structure 1602 can be placed on the patient P and can rely on friction and / or conformity to the patient's anatomy to prevent, or at least partially prevent, movement of the support structure 1602 relative to the patient P. Each of the alignment features 1604 can at least partially define an insertion path that can be used to position the signal delivery device at least proximate to target tissue, including the anterior branch AB of the hypoglossal nerve HGN, the genioglossus muscle GG, and / or any other target tissue described herein. In the illustrated embodiment, the alignment features 1604 are ports extending through the support structure 1602. The insertion tool 214 can then be positioned through / within each port 1604. Additionally or alternatively, each of the alignment features 1604 can include a tool hole, a laser, and / or other suitable alignment features. In these and other embodiments, the alignment features 1604 can be configured to control the insertion depth of the tool 214, for example by having a narrowed inner diameter, by including a stop surface, and / or by another feature configured to contact the tool 214 at a predetermined insertion depth. In some embodiments, the insertion guide 1600 can be used to implant one or more signal delivery devices without the need for an ultrasound probe 201 ( Figure 2A ), which is expected to further increase the speed of implanted signal delivery devices.

[0109] Figure 17 is a partially schematic side view illustrating another signal delivery device 1700 configured in accordance with an embodiment of the present technology. Figure 17 The dimensions shown in FIG are for illustration purposes only, and in at least some embodiments, all or one or more portions of the signal delivery device 1700 may have dimensions other than Figure 17 In at least some embodiments, the signal delivery device 1700 may be structurally and / or functionally similar to the signal delivery device 1700. Figure 1ASignal delivery device 1700 may be at least substantially similar or identical to signal delivery device 100. For example, signal delivery device 1700 is shown as including a housing 1702, an electrode array 1704 coupled to housing 1702, a signal generator 1706, and an antenna 1708. Electrode array 1704 may include a monopolar electrode array or a bipolar (or other multipolar) electrode array. In some embodiments, electrode array 1704 may include electrodes formed from Pt and / or Ir (such as Pt90 / Ir10) and / or one or more other suitable materials. Housing 1702 may be configured to hermetically contain one or more circuit components of signal delivery device 1700, including signal generator 1706 and / or antenna 1708. All or a portion of housing 1702 may be formed from Pt, PtIr, Ti6AL4V, epoxy, TPE, one or more ceramics, and / or one or more other suitable materials. For example, the portion of housing 1702 surrounding antenna 1708 can be formed from epoxy, ceramic, and / or TPE, e.g., to prevent, or at least partially prevent, interference with power transmission to antenna 1708. Optionally, at least a portion of housing 1702 can be electrically activatable and configured to function as an electrode, e.g., when electrode array 1704 is monopolar.

[0110] Additionally, the signal delivery device 1700 includes a lead portion 1703 coupled to the housing 1702 and carrying the electrode array 1704. The lead portion 1703 can be at least substantially flexible and / or otherwise configured to undergo elastic deformation. In some embodiments, the lead portion 1703 can be detachable from the housing 1702 and configured to be coupled to and / or docked with the housing 1702, for example, within the body. In some embodiments, the lead portion 1703 can be formed from one or more thermoplastic polyurethanes (TPUs), such as Tecothane. TM The lead portion 1703 may include one or more wires and / or other conductive elements that electrically couple the electrode array 1704 to the signal generator 1706. The wires / conductive elements may be formed of MP35N and / or one or more other suitable conductive materials.

[0111] Figure 18 A representative set of implantation tools 1801 for implanting a signal delivery device 1800 according to an embodiment of the present technology is shown. The signal delivery device 1800 may include a device that is structurally and / or functionally similar to the signal delivery device 100 ( Figure 1A ) and / or signal delivery device 1700 ( Figure 17 ) at least some features that are at least substantially similar or identical.

[0112] In operation, one end of the signal delivery device 1800 is attached to the proximal suture 1802a and the opposite end is attached to the distal suture 1802b. The proximal suture 1802a is attached to the needle 1804, which may be curved (e.g., Figure 18 ), spiral, or straight. Depending on the size of the signal delivery device 1800, the implantation tool may further include a dilator 1806, an introducer 1808, which may include a cannula through which the signal delivery device 1800 may be positioned within the patient's body, and / or other percutaneous insertion devices configured to facilitate guiding the signal delivery device 1800 into the opening formed by the needle 1804, such as via a Seldinger approach. For example, the introducer 1808 may form a percutaneous insertion path through the patient's skin, and the signal delivery device 1800 may be percutaneously inserted, implanted, injected, and / or the like through the percutaneous insertion path.

[0113] Whether the needle 1804 is bent (e.g. Figure 18 Whether the needle is 20 gauge (as shown) or straight (as may be the case in other embodiments), in certain embodiments, the needle may have a diameter ranging from 20 gauge to 10 gauge or 18 gauge to 12 gauge. The dilator 1806 may have a diameter ranging from 3 Fr to 12 Fr (1 mm to 4 mm).

[0114] Needle 1804 and / or introducer 1808 may be used as described herein, for example, with reference to Figure 2A-11 Any of the insertion paths and / or openings described herein is inserted into the patient P. In some embodiments, the needle 1804 and / or another percutaneous insertion device can be configured to stimulate the patient's tissue during insertion. For example, Figure 18As shown, needle 1804 may include one or more electrodes 1810 positioned at or near the distal end 1812 of needle 1804. The precise location of needle 1804 can be identified by delivering electrical stimulation to the patient through the needle and observing the patient's motor response. In addition to or in lieu of inducing a motor response, a practitioner may use ultrasound (e.g., ultrasound probe 201) and / or another suitable visualization technique. Accordingly, in at least some embodiments, a practitioner may use a combination of visual navigation and stimulation-response navigation to precisely align needle 1804 relative to a stimulation target. As described above, the target may include one or more of the anterior branch AB of the hypoglossal nerve HGN, another portion of the hypoglossal nerve HGN (e.g., the medial branch MB), the genioglossus muscle GG and / or its fiber portions GGo and GGh, and / or another suitable target location. Accordingly, upon introduction of signal delivery device 1800, signal delivery device 1800 is expected to be closer to and / or more closely aligned with the target location. In some embodiments, when operating in a portion of the patient's anatomy where the needle 1804 is difficult to visualize (using, for example, ultrasound), such as near / within the anterior branch AB of the hypoglossal nerve HGN, the practitioner can use stimulus-response navigation to identify the needle's position.

[0115] Depending on the embodiment, the aforementioned elements (e.g., needle 1804, dilator 1806, introducer 1808, etc.) can be axially removed and / or can be pre-cut and peeled. In operation, needle 1804 is introduced into the patient's tissue at a first point, thereby forming a first opening. Needle 1804 can exit the patient's tissue at a second point, thereby forming a second opening. The practitioner can then pull the signal delivery device 1800 through the first opening via needle 1804 and use the proximal suture 1802a and distal suture 1802b to more precisely position the signal delivery device 1800 within the patient's body. In some embodiments, the signal delivery device 1800 can be activated within the patient P to deliver one or more electrical signals to the patient's tissue to confirm that the signal delivery device 1800 is at least positioned proximate to the target tissue.

[0116] In some embodiments, needle 1804 can be hollow, allowing signal delivery device 1800 to be positioned within a patient by inserting signal delivery device 1800 through needle 1804 and percutaneously into the patient's body, with or without the use of sutures 1802a, 1802b and / or via a single opening. In these and other embodiments, one or more other percutaneous insertion devices (such as an introducer 1808, dilator 1806, and / or cannula) can be inserted over needle 1804 to assist in the percutaneous insertion of signal delivery device 1800. For example, needle 1804 can be used to stimulate tissue to identify an implantation site and facilitate placement of one or more dilators and / or cannulas over needle 1804. In this manner, needle 1804 can be used to position a cannula configured to deliver signal delivery device 1800 to the implantation site. In these and other embodiments, needle 1804 can optionally include a lumen and / or an atraumatic tip. In at least some embodiments, needle 1804 can be configured to operate as a dilator and deliver the cannula directly, such that dilator 1806 can be omitted.

[0117] Figure 19 is a block diagram illustrating elements of a system 1901 for treating sleep disorders according to an embodiment of the present technology. The system 1901 may include a wearable device 1903, a charger 1921, one or more implants or implantable devices (e.g., a first implantable device 1900a, a second implantable device 1900b...an nth implantable device 1700n, collectively referred to as "implantable devices 1900"), and a connected device or programmer 1960. Typically, the programmer 1960 may send instructions for generating electrical signals (e.g., signal delivery or waveform parameters) to the wearable device 1903, the wearable device 1903 may send instructions and power to the implantable device(s) 1900, and each of the implantable devices 1900 may generate electrical signals according to the sent instructions and apply the electrical signals to the patient via electrodes carried by the implantable device(s) 1900. The individual implantable devices in the implantable device 1900 may be structurally and / or functionally similar to the implantable device 1903. Figure 1A The signal delivery device 100, Figure 17 signal delivery device 1700, Figure 18 The signal delivery device 1800 and / or other signal delivery devices are at least substantially similar or identical. Additionally, each of the implantable devices 1900 can be implanted in a patient using one or more of the insertion paths and / or one or more of the positions and / or orientations, and / or deliver electrical signals to a previously referenced device. Figure 2A-11 Described is one or more portions of the hypoglossal nerve HGN (including its anterior branch AB and / or distal brachial portion DB) and / or the genioglossus muscle GG.

[0118] Programmer 1960 may include a patient-operated programmer and / or a clinician-operated programmer and may be configured to control one or more characteristics of the electrical signal delivered to the patient. In a representative embodiment, programmer 1960 may include a therapy adjustment module configured to select individual electrodes carried by implantable device(s) 1900 and adjust (e.g., increase or decrease) the amplitude, frequency, pulse width, burst duration, whether the electrode is active or inactive, and / or any other suitable signal delivery parameter. Additionally, programmer 1960 may synthesize information received from the user, wearable device 1903, and / or individual implantable devices in implantable device 1900 (e.g., diagnostic and / or feedback information), and may adjust one or more of the signal delivery parameters based at least in part on the synthesized information. For example, programmer 1960 may be configured to receive one or more inputs corresponding to a patient's tissue collapse pattern, or otherwise identify a location of tissue collapse within the patient's airway, and direct the electrical signal to a specific distal arm portion DB based at least in part on the tissue collapse pattern / location, as previously described with reference to Figures 5A-6C In some embodiments, the input can be based at least in part on data from one or more sensors carried by the wearable device, including one or more non-EMG sensors such as an audio sensor, an accelerometer, an airflow sensor, a myograph (MMG) sensor, and / or any other sensor described herein. In other embodiments, the tissue collapse pattern / location can be identified by the user (e.g., visually) (as previously described herein), and the user can provide input identifying the tissue collapse pattern / location, e.g., based on the user's visualization.

[0119] Programmer 1960 can transmit signal delivery parameters to implantable device 1900 directly and / or via wearable device 1903. For example, programmer 1960 can connect to implantable device 1900 and / or various ones of wearable device 1903 via a wired or wireless communication link, such as WiFi, Bluetooth ("BT"), a cellular connection, and / or any other suitable communication link. In these and other embodiments, programmer 1960 can connect to cloud 1962 and / or other computer services, for example, to upload data received from sensors of wearable device 1903 and / or download information to wearable device 1903 and / or implantable device(s) 1900. In these and other embodiments, programmer 1960 can include a display and / or user interface. A user (e.g., a patient, clinician, and / or other appropriate user) can interact with programmer 1960 via a user interface and / or otherwise control one or more aspects of programmer 1960, for example, to manually adjust one or more signal delivery parameters, to read data received from wearable device 1903 sensors, to provide one or more inputs corresponding to a tissue collapse pattern, and / or to perform other tasks.

[0120] Wearable device 1903 may include a neck collar, a chin strap, a mouthpiece, a pillow, and / or may have other suitable form factors. Wearable device 1903 may include one or more sensors (e.g., a single sensor, a sensor array, and / or other suitable sensor arrangements) configured to collect data associated with the patient. Representative data received from the patient may include respiratory rate, sleep state, wake state, heart rate, audio signals (corresponding to audible snoring, hypopnea events, and / or apnea events), body temperature, head orientation / position, saturated blood oxygen level, airflow level, thyroid movement, tracheal movement, and / or tongue movement, photoplethysmography (PPG) data, and the like, each of which may be received by a corresponding type of sensor (e.g., heart rate data from a heart rate sensor, head orientation / position data from an accelerometer, etc.). The received data may correspond to measurements of the patient's respiratory performance, sleep state, wake state, and / or other suitable metrics, such as a metric used to assign an Apnea-Hypopnea Index (AHI) rating to the patient.

[0121] The wearable device may also include a power source (e.g., a storage power device such as a battery), a power transmission component configured to transmit power and / or signal delivery parameters to the implantable device(s) 1900, and one or more algorithms configured to control one or more aspects of the operation of the wearable device 1903. Each of the sensors may collect data associated with the patient, such as the patient's sleep state and / or respiratory performance. The one or more algorithms may be configured to adjust at least one of the signal delivery parameters based, at least in part, on the data collected by the sensors. In a representative embodiment, the wearable device 1903 may include an integrated sleep, respiratory diagnostic, and / or therapy modulation system configured to adjust or otherwise control one or more delivery parameters of the electrical signals delivered to the patient based on the collected sleep state and / or respiratory performance data (e.g., via one or more algorithms).

[0122] In some embodiments, the wearable device 1903 may further include a cover or housing, at least a portion of which may be removable, for example, to expose the interior or interior portion of the wearable device 1903. In these and other embodiments, the wearable device 1903 cover may include fabric or any other suitable material. Optionally, the wearable device 100 may include a reduced and / or simplified user interface configured to allow a user to interact with and / or otherwise control one or more elements of the wearable device 1903 (e.g., to check the charging status of a power source, adjust one or more signal delivery parameters, etc.).

[0123] A charger 1921 for wearable device 1903 can be configured to provide power to wearable device 1903. Charger 1921 can include a wireless (e.g., inductive) charger, a wired charger (e.g., a wall plug, a charging cable, etc.), and / or any other suitable charger or charging device. Optionally, charger 1921 can include an integrated controller and / or connected devices, for example, to control the charging of wearable device 1903 and / or upload / download data to wearable device 1903 while it is charging.

[0124] Each of the one or more implantable devices 1900 may include an RFID component (e.g., a unique RFID tag that can be used to identify and / or locate the associated implantable device 1900a-n), a power receiving device (e.g., one or more RF power antennas, one or more inductive coils, etc.), a power rectifier / DC-DC converter, circuitry (e.g., one or more application-specific integrated circuits (ASICs), a state machine, etc.), a signal generator, and two or more electrodes, each of which is individually selectable for delivering an electrical 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 power rectifier / DC-DC converter may be operably coupled to the electrode receiver antenna and may be configured to transmit the received power to the signal generator. Additionally, each of the implantable devices 1900 may receive, via the power receiving device and / or one or more other communication components, information regarding one or more delivery parameters of the electrical signal to be generated by the signal generator and / or delivered to the patient via at least one of the electrodes of the one or more implantable devices 1900. The circuitry may include machine-readable instructions associated with the operation of the implantable device(s) 1900. For example, the circuitry may include instructions that, when executed, cause a signal generator to generate an electrical signal having signal delivery parameters received via an electrode receiver antenna. In these and other embodiments, a power receiving device and / or one or more other communication components may be used to transmit information associated with the implantable device 1900 to the wearable device 1903. For example, the implantable device 1900 transmits information associated with one or more signal delivery parameters of an electrical signal applied to the patient to the wearable device 1903. In these and other embodiments, each of the implantable device(s) 1900 may include a hermetically sealed enclosure or housing configured to allow the implantable device(s) 1900 to be implanted in the patient.

[0125] 6. Example

[0126] The following examples provide further embodiments of the present technology:

[0127] 1. A method for addressing sleep apnea in a patient, the method comprising:

[0128] inserting a signal delivery device percutaneously into the patient at a submandibular insertion point;

[0129] advancing the signal delivery device in at least a partially upward direction toward a target location; and

[0130] The signal delivery device is implanted at least proximate the target location, wherein the signal delivery device has an orientation wherein at least a vector component of the orientation is aligned along an inferior-superior axis, and wherein the signal delivery device includes at least one electrode configured to deliver a signal to the target location.

[0131] 2. The method of example 1, wherein implanting the signal delivery device at least proximate to the target location comprises implanting the signal delivery device proximate to or within the patient's genioglossus muscle.

[0132] 3. The method of Example 1, wherein implanting the signal delivery device at least proximate the target location comprises positioning at least a portion of the signal delivery device between the patient's left genioglossus muscle and the patient's right genioglossus muscle.

[0133] 4. A method according to Example 1, wherein implanting the signal delivery device at least near the target location includes implanting the signal delivery device near the patient's hypoglossal nerve.

[0134] 5. The method of Example 4, wherein implanting the signal delivery device proximate to the hypoglossal nerve comprises implanting the signal delivery device proximate to a medial branch of the hypoglossal nerve.

[0135] 6. The method of Example 1, wherein implanting the signal delivery device at least proximate the target location comprises positioning at least a portion of the signal delivery device away from the medial branch of the patient's hypoglossal nerve.

[0136] 7. A method according to Example 1, wherein implanting the signal delivery device at least near the target location includes implanting the signal delivery device near one or more anterior branches of the patient's hypoglossal nerve.

[0137] 8. A method according to Example 7, wherein implanting the signal delivery device near the one or more anterior branches of the hypoglossal nerve includes implanting the signal delivery device near at least one motor end plate of the hypoglossal nerve.

[0138] 9. A method according to Example 7, wherein implanting the signal delivery device near the one or more anterior branches of the hypoglossal nerve includes: implanting the signal delivery device between (i) a first end of the one or more anterior branches and (ii) a second end of the one or more anterior branches, wherein at the first end, a corresponding anterior branch of the one or more anterior branches innervates the patient's genioglossus muscle, and at the second end, the corresponding anterior branch of the one or more anterior branches is separated from the medial branch of the hypoglossal nerve.

[0139] 10. A method according to Example 1, wherein implanting the signal delivery device at least proximate to the target location includes implanting the signal delivery device transverse to multiple anterior branches of the patient's hypoglossal nerve.

[0140] 11. The method of Example 1, wherein advancing the signal delivery device comprises advancing the signal delivery device in a direction at least partially from a front to a rear and / or at least partially from a rear to a front.

[0141] 12. The method of Example 1, wherein advancing the signal delivery device comprises advancing the signal delivery device in a direction at least partially from the inside to the outside and / or at least partially from the outside to the inside.

[0142] 13. The method of Example 1 further includes delivering the signal to the target location to at least partially address the patient's sleep apnea.

[0143] 14. A method according to Example 13, wherein the signal is a first signal delivered at a first time, wherein delivering the first signal includes inducing a first motor response in the patient, and the method further includes delivering a second signal to the target location at a second time to induce a second motor response greater than the first motor response.

[0144] 15. The method of Example 14, wherein the target location includes the genioglossus muscle of the patient.

[0145] 16. The method of example 15, wherein advancing the signal delivery device comprises advancing the signal delivery device along a single at least substantially linear path from a submandibular insertion point to the target location.

[0146] 17. The method of Example 1, wherein implanting the signal delivery device comprises implanting the signal delivery device, wherein at least a portion of the signal delivery device is (i) positioned laterally from the patient's genioglossus muscle and (ii) positioned inferiorly from the patient's hyoglossus muscle.

[0147] 18. The method of Example 1, wherein implanting the signal delivery device comprises percutaneously implanting the signal delivery device without dissecting tissue at a submental region of the patient.

[0148] 19. The method of example 1 further comprising causing the signal delivery device to deliver the signal to determine a position of the signal delivery device relative to the target location.

[0149] 20. A method for addressing sleep apnea in a patient, the method comprising:

[0150] inserting a signal delivery device percutaneously into the patient at a submandibular insertion point, wherein the signal delivery device has an orientation wherein at least a vector component of the orientation is aligned along an inferior-superior axis;

[0151] advancing the signal delivery device in an at least partially superior direction toward anterior branches of the patient's hypoglossal nerve; and

[0152] The signal delivery device is implanted at least proximal to and lateral to the plurality of anterior ramuses, wherein at least one electrode of the signal delivery device is positioned to deliver an electrical signal to the plurality of anterior ramuses.

[0153] 21. A method according to Example 20, wherein advancing the signal delivery device in at least a partially upper direction includes advancing the signal delivery device in at least a partially front to rear direction and / or at least a partially rear to front direction.

[0154] 22. A method according to Example 20, wherein advancing the signal delivery device in at least a partially superior direction includes advancing the signal delivery device in at least a partially medial to lateral direction and / or at least a partially lateral to medial direction.

[0155] 23. The method of Example 20, wherein advancing the signal delivery device comprises advancing the signal delivery device in the orientation.

[0156] 24. The method of Example 20, wherein implanting the signal delivery device comprises implanting the signal delivery device in the orientation.

[0157] 25. A method for addressing sleep apnea in a patient, the method comprising:

[0158] inserting a signal delivery device percutaneously into the patient via a submandibular insertion point, wherein the signal delivery device has an orientation wherein at least a vector component of the orientation is aligned along an inferior-superior axis;

[0159] advancing the signal delivery device in a direction toward at least a portion of the superior portion of the patient's genioglossus muscle; and

[0160] The signal delivery device is implanted at least proximate the genioglossus muscle, wherein at least one electrode of the signal delivery device is positioned to deliver an electrical signal to at least a portion of the genioglossus muscle.

[0161] 26. A method according to Example 25, wherein advancing the signal delivery device in at least a partially upper direction includes advancing the signal delivery device in at least a partially front to rear direction and / or at least partially rear to front direction.

[0162] 27. A method according to Example 25, wherein advancing the signal delivery device in at least a partially superior direction includes advancing the signal delivery device in a direction at least partially from the inside to the outside and / or at least partially from the outside to the inside.

[0163] 28. The method of example 25, further comprising:

[0164] delivering a first signal to the portion of the genioglossus muscle at a first time to induce a first motor response in the genioglossus muscle; and

[0165] At a second time, a second signal is delivered to the portion of the genioglossus muscle to induce a second motor response in the genioglossus muscle, the second motor response being greater than the first motor response.

[0166] 29. The method of Example 25, wherein advancing the signal delivery device comprises advancing the signal delivery device in the orientation.

[0167] 30. The method of Example 25, wherein implanting the signal delivery device comprises implanting the signal delivery device in the orientation.

[0168] 31. The method of Example 25, wherein implanting the signal delivery device at least proximate to the genioglossus muscle comprises implanting the signal delivery device with at least a portion of the signal delivery device positioned within the genioglossus muscle.

[0169] 32. A method according to Example 25, wherein implanting the signal delivery device at least proximate to the genioglossus muscle includes implanting the signal delivery device, wherein at least a portion of the signal delivery device is positioned between the patient's left genioglossus muscle and the patient's right genioglossus muscle.

[0170] 33. A method for addressing sleep apnea in a patient, the method comprising:

[0171] percutaneously inserting a signal delivery device into the patient at an insertion point;

[0172] advancing the signal delivery device toward a target location; and

[0173] The signal delivery device is implanted at least proximate the target location, wherein the signal delivery device has an orientation wherein at least a vector component of the orientation is aligned along an inferior-superior axis, and wherein the signal delivery device includes at least one electrode configured to deliver a signal to the target location.

[0174] 34. The method of Example 33, wherein percutaneously inserting the signal delivery device into the patient at an insertion point comprises percutaneously inserting the signal delivery device into the patient at an intraoral insertion point.

[0175] 35. The method of Example 33, wherein percutaneously inserting the signal delivery device into the patient at an insertion point comprises percutaneously inserting the signal delivery device into the patient at a submandibular insertion point.

[0176] 36. The method of any of Examples 33-35, wherein implanting the signal delivery device at least proximate to the target location comprises implanting the signal delivery device proximate to or within the genioglossus muscle of the patient.

[0177] 37. A method according to any of Examples 33-35, wherein implanting the signal delivery device at least proximate to the target location includes positioning at least a portion of the signal delivery device between the patient's left genioglossus muscle and the patient's right genioglossus muscle.

[0178] 38. A method according to any of Examples 33-35, wherein implanting the signal delivery device at least near the target location includes implanting the signal delivery device near the patient's hypoglossal nerve.

[0179] 39. The method of Example 38, wherein implanting the signal delivery device proximate the hypoglossal nerve comprises implanting the signal delivery device proximate a medial branch of the hypoglossal nerve.

[0180] 40. A method according to any of Examples 33-35, wherein implanting the signal delivery device at least proximate the target location includes positioning at least a portion of the signal delivery device away from a medial branch of the patient's hypoglossal nerve.

[0181] 41. A method according to any of Examples 33-35, wherein implanting the signal delivery device at least near the target location includes implanting the signal delivery device near one or more anterior branches of the patient's hypoglossal nerve.

[0182] 42. A method according to Example 41, wherein implanting the signal delivery device near the one or more anterior branches of the hypoglossal nerve includes implanting the signal delivery device near at least one motor end plate of the hypoglossal nerve.

[0183] 43. A method according to Example 41, wherein implanting the signal delivery device near the one or more anterior branches of the hypoglossal nerve includes implanting the signal delivery device between (i) a first end of the one or more anterior branches and (ii) a second end of the one or more anterior branches, wherein at the first end, a corresponding anterior branch of the one or more anterior branches innervates the patient's genioglossus muscle, and at the second end, the corresponding anterior branch of the one or more anterior branches is separated from the medial branch of the hypoglossal nerve.

[0184] 44. A method according to any of Examples 33-35, wherein implanting the signal delivery device at least proximate to the target location includes implanting the signal delivery device transverse to multiple anterior branches of the patient's hypoglossal nerve.

[0185] 45. A method according to any of Examples 33-35, wherein advancing the signal delivery device includes advancing the signal delivery device in a direction at least partially from a front to a rear and / or at least partially from a rear to a front.

[0186] 46. ​​A method according to any of Examples 33-35, wherein advancing the signal delivery device includes advancing the signal delivery device in a direction at least partially from the inside to the outside and / or at least partially from the outside to the inside.

[0187] 47. The method of any of Examples 33-35, further comprising delivering the signal to the target location to at least partially address the patient's sleep apnea.

[0188] 48. A method according to Example 47, wherein the signal is a first signal delivered at a first time, wherein delivering the first signal includes inducing a first motor response in the patient, and the method further includes delivering a second signal to the target location at a second time to induce a second motor response greater than the first motor response.

[0189] 49. The method of Example 48, wherein the target location includes the genioglossus muscle of the patient.

[0190] 50. The method of example 49, wherein advancing the signal delivery device comprises advancing the signal delivery device along a single at least substantially linear path from the insertion point to the target location.

[0191] 51. A method according to Example 33, wherein advancing the signal delivery device includes advancing the signal delivery device in at least a partially upward direction.

[0192] 52. The method of Example 33, wherein advancing the signal delivery device comprises advancing the signal delivery device in at least a partially downward direction.

[0193] 53. One or more non-transitory computer-readable media bearing instructions that, when executed by one or more processors of a controller for an implantable signal delivery device, cause the controller to perform a method comprising:

[0194] A guided electrical signal is delivered by one or more electrodes carried by the implantable signal delivery device for delivery to a target tissue of a patient, wherein the implantable signal delivery device has an orientation wherein at least a vector component of the orientation is aligned along an inferior-superior axis relative to the target tissue.

[0195] 54. The one or more non-transitory computer-readable media of example 53, wherein the target tissue comprises one or more anterior branches of the patient's hypoglossal nerve, wherein each of the one or more electrodes is configured to deliver the electrical signal to a corresponding one of the one or more anterior branches, and wherein the method further comprises:

[0196] receiving input corresponding to a tissue collapse pattern of the patient; and

[0197] Based at least in part on the input, individual electrodes of the one or more electrodes are selected to deliver the electrical signal to a corresponding anterior limb of the one or more anterior limbs to address the tissue collapse pattern of the patient.

[0198] 55. One or more non-transitory computer-readable media according to example 54, wherein each of the one or more anterior branches innervates a muscle compartment of the patient's genioglossus muscle, wherein directing comprises directing the electrical signal to a corresponding anterior branch of the one or more anterior branches to cause the corresponding muscle compartment to contract, thereby moving the corresponding surface portion of the patient's tongue to reduce or prevent the tissue collapse pattern.

[0199] 56. One or more non-transitory computer-readable media of example 54, wherein the one or more anterior branches innervate muscle compartments of the patient's genioglossus muscle, and wherein directing comprises directing the electrical signal to a corresponding anterior branch of the one or more anterior branches to cause a subset of the muscle compartments to contract, thereby moving a surface portion of the patient's tongue to reduce or prevent the tissue collapse pattern.

[0200] 57. One or more non-transitory computer-readable media according to example 54, wherein each of the one or more anterior branches innervates a muscle compartment of the patient's genioglossus muscle, and wherein directing includes directing the electrical signal to a corresponding anterior branch of the one or more anterior branches to cause the corresponding muscle compartment to contract, thereby at least partially reducing the pressure of at least a portion of the patient's tongue on the patient's soft palate.

[0201] 58. One or more non-transitory computer-readable media of example 54, wherein each of the one or more anterior branches innervates a muscle compartment of the patient's genioglossus muscle, wherein receiving the input comprises receiving input that the pattern of tissue collapse comprises tissue collapse in the posterior palatal portion of the patient's airway, and wherein directing comprises directing the electrical signal to a corresponding anterior branch of the one or more anterior branches to contract the corresponding muscle compartment, thereby increasing airflow through the posterior palatal portion of the patient's airway.

[0202] 59. One or more non-transitory computer-readable media of example 54, wherein each of the one or more anterior branches innervates a muscle compartment of the patient's genioglossus muscle, wherein receiving the input comprises receiving input that the pattern of tissue collapse comprises tissue collapse in the posterior lingual portion of the patient's airway, and wherein directing comprises directing the electrical signal to a corresponding anterior branch of the one or more anterior branches to contract the corresponding muscle compartment, thereby increasing airflow through the posterior lingual portion of the patient's airway.

[0203] 60. The one or more non-transitory computer-readable media of Example 53, wherein directing the electrical signal comprises sending one or more signal delivery parameters to the signal delivery device via an antenna of the signal delivery device.

[0204] 61. One or more non-transitory computer-readable media of example 53, wherein directing the electrical signal comprises sending one or more signal delivery parameters to the signal delivery device via a wearable device configured to be worn by the patient.

[0205] 62. One or more non-transitory computer-readable media of Example 53, wherein the one or more electrodes comprise an electrode array.

[0206] 63. The one or more non-transitory computer-readable media of example 53, wherein the target tissue comprises one or more anterior branches of the patient's hypoglossal nerve, wherein each of the one or more electrodes is (i) positioned across at least a subset of the one or more anterior branches when the signal delivery device is implanted in the patient, and (ii) configured to deliver the electrical signal to a corresponding one of the one or more anterior branches, and wherein the method further comprises:

[0207] receiving input corresponding to a tissue collapse pattern of the patient; and

[0208] Based at least in part on the input, individual electrodes of the one or more electrodes are selected to deliver the electrical signal to a corresponding anterior limb of the one or more anterior limbs to address the tissue collapse pattern of the patient.

[0209] 64. The one or more non-transitory computer-readable media of example 53, wherein the target tissue comprises one or more anterior branches of the patient's hypoglossal nerve, wherein each electrode of the one or more electrodes is (i) positioned transverse to the one or more anterior branches when the signal delivery device is implanted in the patient, and (ii) configured to deliver the electrical signal to a corresponding anterior branch of the one or more anterior branches, and wherein the method further comprises:

[0210] receiving input corresponding to a tissue collapse pattern of the patient; and

[0211] Based at least in part on the input, individual electrodes of the one or more electrodes are selected to deliver the electrical signal to a corresponding anterior limb of the one or more anterior limbs to address the tissue collapse pattern of the patient.

[0212] 65. A system for addressing sleep apnea in a patient, the system comprising:

[0213] an electrode array comprising one or more electrodes and configured to be implanted proximate at least a target tissue of the patient in an orientation wherein at least a vector component of the orientation is aligned along an inferior-superior axis; and

[0214] A controller is communicatively coupled to the electrode array and includes one or more non-transitory computer-readable media having instructions that, when executed by one or more processors of the controller, cause the controller to direct electrical signals to be delivered by the electrode array to the target tissue.

[0215] 66. The system of example 65, wherein:

[0216] The target tissue includes one or more anterior branches of the patient's hypoglossal nerve;

[0217] Each electrode of the electrode array is configured to deliver the electrical signal to a corresponding anterior branch of the one or more anterior branches;

[0218] The controller is configured to receive input corresponding to a tissue collapse pattern of the patient; and

[0219] The instructions further cause the controller to select, based at least in part on the input, one or more electrodes in the electrode array to deliver the electrical signal to a corresponding anterior limb of one or more anterior limbs to address the tissue collapse pattern of the patient.

[0220] 67. A system according to example 66, wherein each of the one or more anterior branches innervates a muscle compartment of the patient's genioglossus muscle, and wherein the instructions causing the controller to direct the electrical signal include instructions causing the controller to direct the electrical signal to a corresponding anterior branch of the one or more anterior branches to contract the corresponding muscle compartment and thereby move the corresponding surface portion of the patient's tongue to reduce or prevent the tissue collapse pattern.

[0221] 68. A system according to example 66, wherein the one or more anterior limbs innervate muscle compartments of the patient's genioglossus muscle, and wherein the instructions causing the controller to direct the electrical signal include instructions causing the controller to direct the electrical signal to individual anterior branches of the one or more anterior limbs to contract a subset of the muscle compartments and thereby move the surface portion of the patient's tongue to reduce or prevent the tissue collapse pattern.

[0222] 69. A system according to example 66, wherein each of the one or more anterior branches innervates a muscle compartment of the patient's genioglossus muscle, and wherein the instructions to cause the controller to direct the electrical signal include instructions to cause the controller to direct the electrical signal to a corresponding anterior branch of the one or more anterior branches to contract the corresponding muscle compartment and thereby at least partially reduce pressure from at least a portion of the patient's tongue on the patient's soft palate.

[0223] 70. A system according to example 66, wherein each of the one or more anterior branches innervates a muscle compartment of the patient's genioglossus muscle, wherein the input includes input that the tissue collapse pattern includes tissue collapse in the posterior palatal portion of the patient's airway, and wherein the instructions to cause the controller to direct the electrical signal include instructions to cause the controller to direct the electrical signal to a corresponding anterior branch of the one or more anterior branches to contract the corresponding muscle compartment to thereby move the corresponding surface portion of the patient's tongue to increase airflow through the posterior palatal portion of the patient's airway.

[0224] 71. The system of Example 66, wherein each of the one or more anterior branches innervates a muscle compartment of the patient's genioglossus muscle, wherein the input comprises an input in which the pattern of tissue collapse comprises tissue collapse in a posterior lingual portion of the patient's airway, and wherein the instructions to the controller to direct the electrical signal comprise instructions to the controller to direct the electrical signal to a corresponding anterior branch of the one or more anterior branches to contract the corresponding muscle compartment to thereby move a corresponding surface portion of the patient's tongue to increase airflow through the posterior lingual portion of the patient's airway.

[0225] 72. The system of Example 65, wherein, when implanted in the patient, the electrode array is positioned on at least a subset of the one or more anterior limbs.

[0226] 73. The system of Example 65, wherein, when implanted in the patient, the electrode array is positioned transversely to the one or more anterior limbs.

[0227] 74. The system of Example 65 further includes an implantable signal delivery device comprising the electrode array and the antenna, wherein the instructions for causing the controller to direct the electrical signal include instructions for causing the controller to send one or more signal delivery parameters to the signal delivery device via the antenna.

[0228] 75. The system of Example 65 further includes a wearable device configured to be worn by the patient and communicatively coupled to the electrode array and the controller, wherein the instructions for causing the controller to direct the electrical signal include instructions for causing the controller to send one or more signal delivery parameters to the signal delivery device via the wearable device.

[0229] 76. The system of Example 65 further includes a signal delivery device implanted at least proximate to the target tissue in the orientation, wherein the signal delivery device includes a housing, and wherein the electrode array is coupled to the housing.

[0230] 77. The system of Example 76, wherein the signal delivery device further comprises the controller.

[0231] 78. A method for addressing sleep apnea in a patient, the method comprising:

[0232] A controller for an implantable signal delivery device is programmed to direct an electrical signal to one or more electrodes in an electrode array carried by the implantable signal delivery device for delivery to a target tissue of a patient, wherein the implantable signal delivery device has an orientation in which at least a vector component of the orientation is aligned along an inferior-superior axis relative to the target tissue.

[0233] 79. The method of Example 78, wherein programming the controller comprises programming the controller to transmit one or more signal delivery parameters of the electrical signal to the implantable signal delivery device via an antenna of the implantable signal delivery device.

[0234] 80. A method according to Example 78, wherein programming the controller includes programming the controller to send one or more signal delivery parameters of the electrical signal to the implantable signal delivery device via a wearable device configured to be worn by the patient.

[0235] 81. A system for addressing sleep apnea in a patient by selectively delivering electrical signals to one or more anterior branches of the patient's hypoglossal nerve, the system comprising:

[0236] an electrode array comprising one or more electrodes configured to be implanted at least proximate to the one or more anterior ramuses in an orientation wherein at least a vector component of the orientation is aligned along an inferior-superior axis of the patient, wherein the one or more anterior ramuses are distal to a medial branch of the hypoglossal nerve; and

[0237] a controller communicatively coupled to the electrode array and comprising one or more non-transitory computer-readable media having instructions that, when executed by one or more processors of the controller, cause the controller to:

[0238] receiving input corresponding to a tissue collapse pattern of the patient;

[0239] selecting, based at least in part on the input, one or more electrodes of the electrode array to deliver the electrical signal to respective ones of the one or more anterior limbs to address the tissue collapse pattern of the patient;

[0240] The electrical signal is delivered to each of the one or more anterior fasciculi via the selected one or more electrodes.

[0241] 82. A system according to example 81, wherein each of the one or more anterior branches innervates a muscle compartment of the patient's genioglossus muscle, and wherein the instructions include instructions causing the controller to deliver the electrical signal to each of the one or more anterior branches to contract the corresponding muscle compartment and thereby move the corresponding surface portion of the patient's tongue to reduce or prevent the tissue collapse pattern.

[0242] 83. The system of example 81 or 82, wherein the one or more anterior branches innervate muscle compartments of the patient's genioglossus muscle, and wherein the instructions include instructions causing the controller to deliver the electrical signal to individual anterior branches of the one or more anterior branches to contract a subset of the muscle compartments and thereby move a surface portion of the patient's tongue to reduce or prevent the tissue collapse pattern.

[0243] 84. A system according to any of Examples 81 to 83, wherein each of the one or more anterior branches innervates a muscle compartment of the patient's genioglossus muscle, and wherein the instructions include instructions for the controller to deliver the electrical signal to each of the one or more anterior branches to cause the corresponding muscle compartment to contract and thereby at least partially reduce pressure from at least a portion of the patient's tongue on the patient's soft palate.

[0244] 85. A system according to any of Examples 81 to 84, wherein each of the one or more anterior branches innervates a muscle compartment of the patient's genioglossus muscle, wherein the input indicates that the tissue collapse pattern includes tissue collapse in the posterior palatal portion of the patient's airway, and wherein the instructions include instructions for the controller to deliver the electrical signal to each of the one or more anterior branches to contract the corresponding muscle compartment to move the corresponding surface portion of the patient's tongue to increase airflow through the posterior palatal portion of the patient's airway.

[0245] 86. A system according to any of Examples 81 to 85, wherein each of the one or more anterior branches innervates a muscle compartment of the patient's genioglossus muscle, wherein the input indicates that the tissue collapse pattern includes tissue collapse in the posterior lingual portion of the patient's airway, and wherein the instructions include instructions for the controller to deliver the electrical signal to each of the one or more anterior branches to contract the corresponding muscle compartment to move the corresponding surface portion of the patient's tongue to increase airflow through the posterior lingual portion of the patient's airway.

[0246] 87. A method for addressing sleep apnea in a patient via electrical signals delivered to one or more anterior branches of the patient's hypoglossal nerve, the method comprising:

[0247] A controller for an implantable signal delivery device is programmed to:

[0248] receiving input corresponding to a tissue collapse pattern of the patient;

[0249] selecting, based at least in part on the input, one or more electrodes in an electrode array carried by an implantable signal delivery device to deliver the electrical signal to respective ones of the one or more anterior limbs to address the tissue collapse pattern of the patient, wherein the implantable signal delivery device has an orientation wherein at least a vector component of the orientation is aligned along an inferior-superior axis relative to the one or more anterior limbs, and wherein respective electrodes in the electrode array are positionable to deliver the electrical signal to corresponding ones of the one or more anterior limbs; and

[0250] The electrical signal is directed to each of the one or more anterior limbs via the selected one or more electrodes.

[0251] 88. The method of Example 87, wherein each of the one or more anterior branches innervates a muscle compartment of the patient's genioglossus muscle, and wherein programming comprises programming the controller to direct the electrical signal to each of the one or more anterior branches to cause the corresponding muscle compartment to contract, thereby moving the corresponding surface portion of the patient's tongue to reduce or prevent the tissue collapse pattern.

[0252] 89. The method of Examples 87 or 88, wherein the one or more anterior limbs innervate muscle compartments of the patient's genioglossus muscle, and wherein programming comprises programming the controller to direct the electrical signal to individual ones of the one or more anterior limbs to cause a subset of the muscle compartments to contract, thereby moving a surface portion of the patient's tongue to reduce or prevent the tissue collapse pattern.

[0253] 90. A method according to any of Examples 87 to 89, wherein each of the one or more anterior branches innervates a muscle compartment of the patient's genioglossus muscle, and wherein programming includes programming the controller to direct the electrical signal to each of the one or more anterior branches to cause the corresponding muscle compartment to contract, thereby at least partially reducing pressure from at least a portion of the patient's tongue on the patient's soft palate.

[0254] 91. A method according to any of Examples 87 to 90, wherein each of the one or more anterior branches innervates a muscle compartment of the patient's genioglossus muscle, wherein the input indicates the pattern of tissue collapse, including tissue collapse in the posterior palatal portion of the patient's airway, and wherein programming includes programming the controller to direct the electrical signal to each of the one or more anterior branches to contract the corresponding muscle compartment, thereby moving a corresponding surface portion of the patient's tongue to increase airflow through the posterior palatal portion of the patient's airway.

[0255] 92. A method according to any of Examples 87 to 91, wherein each of the one or more anterior branches innervates a muscle compartment of the patient's genioglossus muscle, wherein the input indicates that the tissue collapse pattern includes tissue collapse in the posterior lingual portion of the patient's airway, and wherein programming includes programming the controller to direct the electrical signal to each of the one or more anterior branches to contract the corresponding muscle compartment to move the corresponding surface portion of the patient's tongue to increase airflow through the posterior lingual portion of the patient's airway.

[0256] 93. A system for addressing sleep apnea in a patient, the system comprising:

[0257] an electrode array comprising one or more electrodes and configured to be implanted proximate at least a target tissue of the patient in an orientation wherein at least a vector component of the orientation is aligned along an inferior-superior axis of the patient; and

[0258] A controller is communicatively coupled to the electrode array and includes one or more non-transitory computer-readable media having instructions that, when executed by one or more processors of the controller, cause the controller to direct delivery of electrical signals by the electrode array to the target tissue.

[0259] 94. The system of Example 93, wherein the target tissue comprises one or more anterior branches of the patient's hypoglossal nerve, and wherein, when implanted in the patient, the electrode array is positioned to span at least a subset of the one or more anterior branches.

[0260] 95. A system according to any of Examples 93 to 94, wherein the target tissue includes one or more anterior branches of the patient's hypoglossal nerve, and wherein, when implanted in the patient, the electrode array is positioned transverse to the one or more anterior branches.

[0261] 96. A system according to any of Examples 93 to 95, wherein the target tissue includes one or more branches of the patient's hypoglossal nerve distal to the medial branch of the patient's hypoglossal nerve, and wherein the electrode array is implanted in the patient to deliver the electrical signal to individual ones of the one or more branches.

[0262] 97. The system of any of Examples 93 to 96, wherein the target tissue comprises the patient's genioglossus muscle, and wherein the electrode array is implanted within the genioglossus muscle in the orientation.

[0263] 98. A system according to any of Examples 93 to 97, wherein the target tissue includes one or both of the patient's left genioglossus muscle and the patient's right genioglossus muscle, and wherein the electrode array is implanted in the orientation and at least partially between the left genioglossus muscle and the right genioglossus muscle.

[0264] 99. The system of any one of Examples 93 to 98 further includes an implantable signal delivery device comprising an electrode array and an antenna, wherein the instructions for causing the controller to direct the electrical signal include instructions for causing the controller to send one or more signal delivery parameters to the implantable signal delivery device via the antenna.

[0265] 100. The system of any one of Examples 93 to 99 further includes a wearable device configured to be worn by the patient and communicatively coupled to the electrode array and the controller, wherein the instructions causing the controller to direct the electrical signal include instructions causing the controller to send one or more signal delivery parameters to the implantable signal delivery device via the wearable device.

[0266] 101. The system of any one of Examples 93 to 100 further includes a signal delivery device implanted at least proximate to the target tissue in the orientation, wherein the signal delivery device includes a shell, and wherein the electrode array is coupled to the shell.

[0267] 102. The system of Example 101, wherein the signal delivery device further comprises the controller.

[0268] 103. A method for addressing sleep apnea in a patient, the method comprising:

[0269] A controller for an implantable signal delivery device is programmed to direct an electrical signal to one or more electrodes in an electrode array carried by the implantable signal delivery device for delivery to a target tissue of a patient, wherein the implantable signal delivery device has an orientation wherein at least a vector component of the orientation is aligned or configured to be aligned along an inferior-superior axis relative to the target tissue.

[0270] 104. The method of Example 103, wherein programming the controller comprises programming the controller to transmit one or more signal delivery parameters of the electrical signal to the implantable signal delivery device via an antenna of the implantable signal delivery device.

[0271] 105. The method of Examples 103 or 104, wherein programming the controller comprises programming the controller to send one or more signal delivery parameters of the electrical signal to the implantable signal delivery device via a wearable device configured to be worn by the patient.

[0272] 106. A method according to any of Examples 103 to 105, wherein the target tissue includes one or more anterior branches of the patient's hypoglossal nerve, and the method further includes implanting the implantable signal delivery device at least proximate to the one or more anterior branches in the orientation.

[0273] 107. A method according to any of Examples 103 to 106, wherein implanting the implantable signal delivery device at least proximate to the one or more anterior branches includes positioning at least a portion of the implantable signal delivery device away from the medial branch of the patient's hypoglossal nerve.

[0274] 108. A method according to any of Examples 103 to 107, wherein the target tissue includes at least one genioglossus muscle of the patient.

[0275] 109. The method of Example 108 further includes implanting the implantable signal delivery device near or within the genioglossus muscle.

[0276] 110. The method of Examples 108 or 109, wherein implanting comprises positioning at least a portion of the implantable signal delivery device between the patient's left genioglossus muscle and the patient's right genioglossus muscle.

[0277] In accordance with the foregoing, positioning a signal delivery device as described herein to deliver electrical signals to one or more of the anterior branches AB of the hypoglossal nerve HGN and / or the genioglossus muscles GG is believed to reduce or prevent retraction stimulation and / or produce a net positive protrusive response (e.g., a protrusive response that is greater than the retraction response). In at least some embodiments, applying the electrical signal to one or more of the anterior branches AB and / or directly to one or both of the patient's genioglossus muscles GG is expected to provide a gradual dose-response activation and thereby induce a gradual patient motor response. Additionally or alternatively, positioning / orienting the signal delivery device such that at least a vector component of the orientation of the signal delivery device is aligned with the inferior-superior axis is expected to reduce the amount of power required to generate an effective therapeutic signal and / or increase the amount of target tissue (e.g., the amount of anterior branches AB) that receives the electrical signal from the signal delivery device. This can include, for example, positioning the signal delivery device transverse to one or more of the anterior branches AB. In these and other embodiments, the positions / orientations described herein are expected to reduce or minimize changes in the position / orientation of the signal delivery device during insertion and / or after implantation, and / or increase the speed and / or accuracy with which the signal delivery device can be positioned at least proximate to a target location.

[0278] It should be understood that specific embodiments of the disclosed technology have been described herein for illustrative purposes, but various modifications may be made without departing from the present technology. For example, a signal delivery device may include a lead, and one or more of the electrodes of the signal delivery device may be carried by the lead. In some embodiments, at least a portion of the signal delivery device (e.g., the lead portion) may be flexible or curved (e.g., arcuate, spiral, etc.). Curved signal delivery devices are expected to have improved stability compared to other signal delivery devices. In some embodiments, one end of the lead portion of the signal delivery device can be positioned in the patient's neck and / or jaw, and the opposite end of the lead portion can be tunneled to an implantable pulse generator implanted in the patient's chest. In some embodiments, the first end of the signal delivery device can be positioned away from the second, opposite end of the signal delivery device during insertion, while in other embodiments, the second end can be positioned away from the first end. Certain aspects of the technology described in the context of specific embodiments may be combined or eliminated in other embodiments. For example, two signal delivery devices may be implanted to bilaterally target tissue in a patient (e.g., the left and right anterior branches of the hypoglossal nerve) and / or to target different tissues on the left and right sides of a patient (e.g., the left anterior branch of the hypoglossal nerve and the right genioglossus muscle). Furthermore, while advantages associated with certain embodiments of the disclosed technology have been described in the context of those embodiments, other embodiments may also exhibit such advantages, and not all embodiments must exhibit such advantages to fall within the scope of the present technology. Accordingly, the present disclosure and associated technology may encompass other embodiments not expressly shown or described herein.

[0279] As used herein, the phrase "and / or," as in "A and / or B," refers to A alone, B alone, and both A and B. As used herein, the terms "about" and "approximately" refer to values ​​within 10% of the stated value.

[0280] In the event that any material incorporated by reference herein conflicts with the present disclosure, the present disclosure controls.

Claims

1. A method for treating sleep apnea in a patient, the method comprising: inserting a signal delivery device percutaneously into the patient at a submandibular insertion point, wherein the signal delivery device has an orientation wherein at least a vector component of the orientation is aligned along an inferior-superior axis; advancing the signal delivery device in an at least partially superior direction toward a plurality of anterior branches of the patient's hypoglossal nerve; and The signal delivery device is implanted transverse to the hypoglossal nerve and at least proximate to the plurality of anterior ramuses, wherein at least one electrode of the signal delivery device is positioned to deliver an electrical signal to the plurality of anterior ramuses.

2. The method according to claim 1, wherein Advancing the signal delivery device includes advancing the signal delivery device in a front to rear direction.

3. The method according to claim 1, wherein Advancing the signal delivery device includes advancing the signal delivery device in a rearward to frontward direction.

4. The method according to claim 1, wherein Advancing the signal delivery device includes advancing the signal delivery device in a medial to lateral direction.

5. The method according to claim 1, wherein Advancing the signal delivery device includes advancing the signal delivery device in a direction from the outside to the inside.

6. The method according to claim 1, wherein Advancing the signal delivery device includes advancing the signal delivery device toward the plurality of anterior branches using a percutaneous injection needle carrying the signal delivery device.

7. The method according to claim 1, wherein Implanting the signal delivery device includes deploying the signal delivery device from within a percutaneous injection needle at least proximate the plurality of anterior branches.

8. The method according to claim 1, wherein Advancing the signal delivery device includes advancing the signal delivery device under ultrasound guidance.

9. The method according to claim 1, wherein Advancing the signal delivery device includes advancing the signal delivery device along a single at least substantially linear path from the submandibular insertion point toward the plurality of anterior ramuses.

10. The method according to claim 1, wherein Implanting the signal delivery device laterally to the hypoglossal nerve includes implanting the signal delivery device laterally to the plurality of anterior branches.

11. The method according to claim 1, wherein Percutaneously inserting the signal delivery device includes inserting the signal delivery device via percutaneous injection.

12. The method according to claim 1, wherein Percutaneously inserting the signal delivery device includes percutaneously inserting the signal delivery device without dissecting tissue at the submental region of the patient.

13. The method of claim 1, further comprising causing the signal delivery device to deliver an electrical signal to determine a position of the signal delivery device relative to the plurality of anterior limbs.

14. The method according to claim 1, wherein Implanting the signal delivery device includes implanting the signal delivery device such that at least a portion of the signal delivery device is positioned within the genioglossus muscle of the patient.

15. The method according to claim 1, wherein The at least one electrode is part of an electrode array carried by the signal delivery device, and wherein implanting the signal delivery device comprises implanting the signal delivery device such that at least a portion of the electrode array is within the genioglossus muscle of the patient.

16. The method according to claim 1, wherein Percutaneously inserting the signal delivery device into the patient at the submandibular insertion point includes inserting the signal delivery device at an insertion point between the patient's hyoid bone and the patient's chin.

17. The method according to claim 1, wherein Percutaneously inserting the signal delivery device into the patient at the submandibular insertion point includes inserting the signal delivery device at an insertion point between a left side and a right side of the patient's mandible.

18. The method of claim 1, further comprising: Prior to percutaneously inserting the signal delivery device, the patient's head is moved to expose the submandibular insertion point.

19. The method of claim 1, further comprising: Prior to percutaneously inserting the signal delivery device, the patient's head is rotated posteriorly to expose the submandibular insertion point.

20. The method according to claim 1, wherein The at least one electrode is part of an electrode array carried by a lead portion of the signal delivery device, and wherein implanting the signal delivery device comprises implanting the electrode array to deliver the electrical signal to the plurality of anterior fasciculi.

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