Introducer system for sleep apnea treatment devices and methods of using the same

Abstract

The present technology is generally directed to introducer systems for sleep apnea treatment devices and methods of using the same. The introducer systems of the present technology can be used to accurately place one or more signal delivery devices within a patient to deliver one or more modulation signals to one or more specific target tissues. For example, a practitioner can use an introducer system to identify a target tissue and position at least one signal delivery device at least proximate to the target tissue. The introducer system can include a delivery device and a dilator, one or both of which can be electrically activatable and configured to deliver one or more electrical signals to a patient. The practitioner can determine and / or adjust a position and / or an orientation of the introducer system relative to the target tissue based on the patient's response to the delivered electrical signals.

Description

Attomey Docket No.: 132368.8037.WO00INTRODUCER SYSTEM FOR SLEEP APNEA TREATMENT DEVICES AND METHODS OF USING THE SAMECROSS-REFERENCE TO RELATED APPLICATION[00011 The present application claims priority to U.S. Provisional App. No. 63 / 746,140; filed on January 16, 2025; and titled “INTRODUCER SYSTEM FOR SLEEP APNEA TREATMENT DEVICES AND METHODS OF USING THE SAME”; the entirety of which is hereby incorporated by reference herein.TECHNICAL FIELD

[0002] The present technology is directed to introducer systems for sleep apnea treatment devices and methods of using the same.BACKGROUND[00031 Obstructive sleep apnea (OSA) is a medical condition in which a patient’s upper airway is occluded (partially or fully) during sleep, causing sleep arousal. Repeated occlusions of the upper airway may cause sleep fragmentation, which in turn may result in sleep deprivation, daytime tiredness, and / or malaise. More serious instances of OSA may increase the patient’s risk for stroke, cardiac arrhythmias, high blood pressure, and / or other disorders.[0004| OSA may be characterized by the tendency for soft tissues of the upper airway to collapse during sleep, thereby occluding the upper airway. OSA is typically caused by the collapse of the patient’s soft palate, oropharynx, tongue, epiglottis, or combination thereof, into the upper airway, which in turn may obstruct normal breathing and / or cause arousal from sleep.

[0005] Some treatments have been available for OSA including, for example, surgery, continuous positive airway pressure (CPAP) machines, and electrical stimulation of muscles or related nerves associated with the upper airway to move the tongue (or other upper airway tissue). Surgical techniques have included procedures to remove portions of a patient’s tongue and / or soft palate, and other procedures that seek to prevent the tongue from collapsing into the back of the pharynx. These surgical techniques are very invasive. CPAP machines seek to maintain upper airway patency by applying positive air pressure at the patient’s nose and mouth. However, these machines are uncomfortable, cumbersome, and may have low compliance rates.-1- 184268789.1Attomey Docket No.: 132368.8037.WO00

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

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

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

[0009] FIG. 1C is another partially schematic illustration of representative neural structures and musculature of the patient's lower jaw and neck

[0010] FIG. 2A is a partially schematic illustration of a modulation therapy system configured in accordance with embodiments of the present technology.

[0011] FIG. 2B is a partially schematic illustration of the system of FIG. 2A in accordance with additional embodiments of the present technology.

[0012] FIG. 2C is a side view of a signal delivery device and a lead of the system of FIG.2A in accordance with embodiments of the present technology.[0013 { FIG. 2D is a distal end view of the signal delivery device and the lead of FIG. 2C in accordance with embodiments of the present technology.

[0014] FIG. 3A is a side view of an introducer system configured in accordance with embodiments of the present technology.

[0015] FIG. 3B is a partially exploded view of the introducer system of FIG. 3 A.

[0016] FIG. 3C is a side view of an electrode array positioned within a sheath of the introducer system of FIG. 3 A, in accordance with embodiments of the present technology.

[0017] FIG. 3D is a side view of a lead recapture tool configured in accordance with embodiments of the present technology.

[0018] FIG. 4 is a flow diagram of a method of using an introducer system in accordance with embodiments of the present technology.-2- 184268789.1Attomey Docket No.: 132368.8037.WO00

[0019] FIGS. 5A-5F are side views of the introducer system of FIGS. 3A and 3B during different stages of the method of FIG. 4, in accordance with embodiments of the present technology.

[0020] FIG. 6 is a flow diagram of a method of preparing a signal delivery device for implantation in accordance with embodiments of the present technology.[0021| FIGS. 7A-7C are side views of the signal delivery device of FIG. 3C during different stages of the method of FIG. 6, in accordance with embodiments of the present technology.

[0022] FIG. 8 is a flow diagram of a method for recapturing a signal delivery device in accordance with embodiments of the present technology.

[0023] FIGS. 9A-9D are side views of the signal delivery device of FIG. 3C during different stages of the method of FIG. 8, in accordance with embodiments of the present technology.

[0024] FIG. 10 is a flow diagram of a method for implanting one or more signal delivery devices in a patient to at least partially address the patient’s sleep apnea, in accordance with embodiments of the present technology.

[0025] FIGS. 11 A-l IN are side views of the introducer system of FIG. 3 A and / or one or more signal delivery devices during different stages of the method of FIG. 10, in accordance with embodiments of the present technology.DETAILED DESCRIPTION

[0026] The present technology is discussed under the following headings for ease of readability:Heading 1: “Introduction”Heading 2: “Patient Physiology” (with a focus on FIGS. 1A-1C)Heading 3 : “Modulation Therapy System and Associated Sleep Apnea Treatment Devices” (with a focus on FIGS. 2A-2D)Heading 4: “Introducer System, Associated Devices, and Methods of Using the Same” (with a focus on FIGS. 3 A-l IN)Heading 5 : “Examples”

[0027] The headings provided herein are for convenience only and are not intended to limit or interpret the scope or meaning of the technology. For example, while embodiments of -3- 184268789.1Attomey Docket No.: 132368.8037.WO00the present technology are described under the selected headings indicated above, other embodiments of the technology can include elements discussed under multiple headings. Accordingly, the fact that an embodiment may be discussed under a particular heading does not necessarily limit that embodiment to only the elements discussed under that heading. 1. Introduction

[0028] Electrical modulation therapy for obstructive sleep apnea (OSA) typically includes delivering a signal (e.g., an electrical signal) that modulates nerves and / or muscles to (i) cause the tongue and / or other soft tissue to move to reduce or clear a breathing obstruction and / or to (ii) change the tone of these and / or other tissue(s) (e.g., tighten and / or stiffen tissue(s) without or substantially without muscular contraction or extension that induces movement) to at least partially prevent these tissue(s) from collapsing and / or otherwise obstructing the patient’s ability to breath. The electrical modulation can, for example, remove an obstruction of the upper airway and / or prevent the tongue or other soft tissue from collapsing or obstructing the airway. As used herein, the terms “modulate” and “stimulate” are used interchangeably to mean having an effect on an effect on a nerve, a muscle and / or other tissue that in turn has an effect on one or more motor functions (e.g., a breathing-related motor function).

[0029] Representative methods and apparatuses for reducing the occurrence and / or severity of a breathing disorder, such as OSA, OSA with complete concentric collapse (“CCC”), central sleep apnea, and / or the like are disclosed herein. In some embodiments, a signal delivery device is implanted at least proximate to one or more target tissues of the patient’s upper airway, such as one or more nerves that innervate a muscle in the patient’s airway and / or oral cavity. The signal delivery device can be implanted in the patient via a minimally invasive percutaneous injection. The signal delivery device can receive power and / or be recharged wirelessly from an external device and use the received power to generate and / or deliver accurately targeted modulation signals (e.g., electrical signals, stimulation pulses, etc.) to the target tissues, thereby improving the patient's upper airway patency and / or the tone of the tissue of the intraoral cavity to treat sleep apnea. The external device can include one or more mouthpiece portions, collar portions, chinstrap portions, pillow portions, mattress overlay portions, and / or one or more other suitable wearable structures.

[0030] Representative target tissues include nerves such as the ansa cervicalis nerve and / or the hypoglossal nerve, which are located adjacent and / or around the oral cavity or in the neck. Stimulating the ansa cervicalis nerve can induce caudal traction (e.g., of the trachea),-4- 184268789.1Attomey Docket No.: 132368.8037.WO00lower or depress the hyoid bone, and / or stabilize or stiffen the tongue and / or soft tissues of the upper airway. This, in turn, can reduce or prevent tissue collapse and / or other airflow obstructions in the patient’s airway, thereby improving airflow through the upper airway and mitigating or even alleviating the breathing obstruction. For example, because the tongue is attached to the hyoid bone, lowering the hyoid bone can (i) draw the tongue downwardly / inferiorly and prevent, or at least partially prevent, the tongue and / or associated tissues from obstructing the patient’s airway, and / or (ii) improve airflow through the upper airway. Stimulating the hypoglossal nerve can cause the patient’s tongue to move anteriorly / forward and / or improve tissue tone to prevent the tongue and / or other soft tissues in the airway from collapsing onto the back of the patient’s pharynx and / or into the upper airway. Such movement of potentially obstructive tissue in the upper airway / pharynx is expected to improve the patient’s sleep by mitigating or alleviating the obstruction. Further target tissues can include one or more muscles innervated by the hypoglossal nerve and / or the ansa cervicalis nerve (e.g., one or more of the patient’s infrahyoid strap muscles, including the sternohyoid muscles and / or the sternothyroid muscles), the glossopharyngeal nerve, the pharyngeal branches of the glossopharyngeal nerve, the pharyngeal plexus, the C2 or C3 spinal nerve, a lateral part of the epidural space at the Cl, C2, and C3 vertebral bodies, the pharyngeal branches of the glossopharyngeal nerve, one or more of the other target tissues described herein, and / or other suitable and / or therapeutically effective target tissues. Accordingly, the devices and associated methods disclosed herein can improve the patient's sleep by moving and / or stabilizing potentially obstructing tissue in various portions of the patient’s airway.

[0031] Representative embodiments described herein include introducer systems that can be used to accurately place one or more signal delivery devices within a patient to deliver one or more modulation signals to one or more specific target tissues, e.g., specific nerves and / or specific positions along a nerve. Such locations include one or more locations along the patient's ansa cervicalis nerve, hypoglossal nerve, and / or vagus nerve. Additional locations include nerves that innervate muscles (e.g., palatal, oropharyngeal, laryngeal, omohyoid, sternohyoid, sternothyroid, thyrohyoid, nasal, lingual, pharyngeal, infrahyoid, diaphragmatic, and / or intercostal muscles) of the patient’s airway and / or portions thereof. The target location can be identified with respect to any of, or any combination of, intrinsic or extrinsic muscles, associated nerve branches and / or portions thereof, and / or other physiological features.

[0032] In some aspects of the present technology, a practitioner or other user can use an introducer system to (i) identify a target tissue and (ii) position at least one signal delivery -5- 184268789.1Attomey Docket No.: 132368.8037.WO00device at least proximate to the target tissue, e.g., so that the signal delivery device can deliver one or more electrical and / or other modulation signals to the target tissue. In at least some embodiments, for example, the introducer system includes a delivery device and a dilator. The dilator can be received within and / or positioned to extend at least partially beyond the delivery device. The delivery device and / or the dilator can be electrically activatable and configured to deliver one or more electrical signals to a patient. A user can insert the delivery device and the dilator into the patient percutaneously and advance the delivery device and the dilator together toward a target tissue while delivering one or more electrical signals to the patient. Based on the patient’s response to the one or more electrical signals, a user can determine a position and / or an orientation of the introducer system relative to the target tissue. The user can reposition and / or reorient the introducer system as needed, e.g., unless or until the delivery device is in a desired position and / or orientation relative to the target tissue, at which point the user can remove the dilator from within the delivery device and use the delivery device to position a signal delivery device at least proximate to the target tissue. Accordingly, the present technology allows a user to position signal delivery devices at least proximate to a target tissue in a procedure that is expected to be quick and minimally invasive. For example, at least some of the methods disclosed herein can be completed in an outpatient or ear, nose, and throat (ENT) office, which is expected to result in better and / or improved patient adoption and / or reduce the cost of the procedure. Additionally, by identifying the target tissue and / or the patient’s response to modulation signals before implanting the signal delivery device, the present technology is expected to increase the accuracy with which the user can position the signal delivery device and / or reduce the likelihood that the signal delivery device needs to be repositioned after implantation.[0033 | In one representative embodiment, a method of using a introducer system in accordance with embodiments of the present technology includes: (i) navigating under ultrasound until a tip of a dilator of the introducer system is observed to be in the general vicinity of a target nerve; (ii) continuing to navigate using the tip as an active electrode (cathode) and one or more sheath electrodes of the introducer system as grounds while also observing the patient for twitching and / or other motor responses to indicate that the target nerve is receiving modulation; (iii) using tonic stimulation from the tip to the sheath electrodes to assess the patient’s response, e.g., using nasoendoscopy and / or other characteristic measurements; (iv) using a combination of tip-to-sheath electrode and sheath electrode-to-sheath electrode tonic stimulation to advance the introduce system until the sheath electrodes-6- 184268789.1Attomey Docket No.: 132368.8037.WO00are positioned at least proximate to the target nerve; (v) withdrawing the dilator and advancing the signal delivery device through the sheath and, optionally, delivering modulation signal(s) via the sheath electrodes on the delivery tool one or more times to confirm the desired response is maintained; (vi) exposing an electrode array of the signal delivery device and using it to deliver one or more electrical signals to the patients to confirm that the desired response is maintained; and (vii) anchoring the signal delivery device.

[0034] In some aspects, the present technology allows the user to check a representative stimulation response before delivering an implantable device. This has several benefits. For example, this can allow the user to rely on measurements instead of twitch interpretation. These measurements can include airflow, endoscopy (e.g., nasoendoscopy), ultrasound, neuromuscular, any other measurements, and / or combinations thereof which can provide increased confidence prior to signal delivery device deployment compared to other delivery approaches that rely solely on twitch response. In some aspects, the present technology is expected to allow a precise translation from sheath position to signal delivery device position, allowing the user to anchor the signal delivery device with confidence and reduce or prevent the need to reposition the device (e.g., post-anchoring) due to uncertainties in accuracy between needle tip, twitch interpretation, and / or Seidinger approach. In some aspects, the present technology allows a user to consider a signal delivery device’s orientation relative to a target tissue, including whether and / or how changes to the orientation increase or decrease the patient’s modulation response. For example, the user can check the patient’s motor response along the full length of the delivery array (e.g., tip and / or sheath electrodes) to see the impacts of various different orientations before placing the signal delivery device. This can give the user a chance to ensure good placement for all (or at least a majority or subset) of the signal delivery device’s electrodes and / or can let the user measure the full range of available responses before at least partially- or fully-anchoring the signal delivery device in place.

[0035] Several embodiments of the present technology are described with reference to positioning signal delivery devices to treat sleep apnea or other breathing obstructions. However, the present technology is not limited to these use cases and a person of ordinary skill in the art will appreciate that at least some embodiments of the present technology can be utilized to position signal delivery devices to deliver modulation signals to other nerves and / or to otherwise address other patient health conditions that may or may not involve obstructed breathing. For example, at least some embodiments of the present technology can be used to-7- 184268789.1Attomey Docket No.: 132368.8037.WO00position signal delivery devices at least proximate to one or more peripheral nerves for the purpose of treating chronic pain and / or other neurological disorders.

[0036] Many embodiments of the technology described below may take the form of computer- or machine- or controller-executable instructions, including routines executed by a programmable computer or controller. Those skilled in the relevant art will appreciate that the technology can be practiced on computer / controller systems other than those shown and described below. The technology can be embodied in a special-purpose computer, controller or data processor that is specifically programmed, configured, or constructed to perform one or more of the computer-executable instructions described below. Accordingly, the terms “computer” and “controller” as generally used herein refer to any suitable data processor and can include Internet appliances and hand-held devices (including palm-top computers, wearable computers, tablets, cellular or mobile phones, multi-processor systems, processorbased or programmable consumer electronics, network computers, minicomputers and the like). Information handled by these computers can be presented at any suitable display medium, including a liquid crystal display (LCD). In some embodiments, manufacturers or other suitable entities can provide instructions to practitioners for executing the methods disclosed herein. Manufacturers can also program devices of the disclosed systems to carry out at least some of these methods.[0037| The present technology can also be practiced in distributed environments, where tasks or modules are performed by remote processing devices that are linked through a communications network. In a distributed computing environment, program modules or subroutines may be located in local and remote memory storage devices. Aspects of the technology described below may be stored or distributed on any suitable computer-readable media, including one or more ASICs, (e.g., with addressable memory), as well as distributed electronically over networks. Data structures and transmissions of data particular to aspects of the technology are also encompassed within the scope of the embodiments of the technology.2. Patient Physiology

[0038] FIG. 1 A illustrates a patient P relative to a coordinate system in which the x-axis denotes the anterior-posterior directions, the y-axis denotes the superior-inferior and / or cranial-caudal directions, and the z-axis denotes the medial-lateral directions. The patient P has a hard palate HP which overlies the tongue T and forms the roof of the oral cavity OC (e.g., the mouth). The hard palate HP includes bone support BS, and thus does not typically deform-8- 184268789.1Attomey Docket No.: 132368.8037.WO00during breathing. The soft palate SP, which is made of soft tissue such as membranes, fibrous material, fatty tissue, and muscle tissue, extends rearward (e.g., in a posterior direction) from the hard palate HP toward the back of the pharynx PHR. More specifically, an anterior end AE of the soft palate SP is anchored to a posterior end of the hard palate HP, and a posterior end PE of the soft palate SP is unattached. Because the soft palate SP does not contain bone or hard cartilage, the soft palate SP is flexible and may collapse onto the back of the pharynx PHR and / or flap back and forth (e.g., especially during sleep).

[0039] The pharynx PHR, which passes air from the oral cavity OC and the nasal cavity NC into the trachea TR, is the part of the throat situated inferior to (below) the nasal cavity NC, posterior to (behind) the oral cavity OC, and superior to (above) the esophagus ES. The pharynx PHR is separated from the oral cavity OC by the palatoglossal arch PGA, which runs downward on either side to the base of the tongue T. Although not shown for simplicity, the pharynx PHR includes the nasopharynx, the velopharynx, the oropharynx, and the laryngopharynx. The nasopharynx lies between the base of the cranium and the soft palate SP. The velopharynx is the section of the nasopharynx bounded ventrally by the soft palate. The oropharynx lies behind the oral cavity OC and extends from the soft palate SP to the pharyngoepiglottic fold. The oropharynx opens anteriorly into the oral cavity OC. The anterior portion of the oropharynx includes the base of the tongue T. A flap of connective tissue called the epiglottis EP closes over the glottis (not shown for simplicity) when food is swallowed, to prevent aspiration. The laryngopharynx is the portion of the pharynx that divides anteriorly into the larynx and posteriorly into the esophagus, and is bounded by the pharyngoepiglottic fold superiorly and the upper esophageal sphincter inferiorly. Below the tongue T is the lower jaw or mandible M, and the geniohyoid muscle GH, which is one of the muscles, in addition to the infrahyoid strap muscles, that controls the movement of the hyoid bone HB. Stimulating one or more of the patient’s infrahyoid strap muscles (and / or a nerve innervating one or more of the patient’ s infrahyoid strap muscles) can lower the hyoid bone HB, including in an anterior or posterior direction such as shown using dashed-line arrows in FIG. 1A, and produce a corresponding movement of at least the base of the patient’s tongue T. As described in greater detail below, lowering the base of the patient’s tongue T can open the patient’s airway, and / or reduce or prevent tissue collapse that at least partially obstructs the patient’ s airway, to increase airflow through the oral cavity OC and address OSA and / or other breathing obstructions.

[0040] FIG. IB is a partially schematic illustration of representative neural structures and musculature of the patient's lower jaw and neck. The omohyoid muscle OHM extends -9- 184268789.1Attomey Docket No.: 132368.8037.WO00between the hyoid bone HB and the scapula. The sternohyoid muscle SHM extends between the hyoid bone HB and the sternum ST, and the sternothyroid muscle STM extends between the sternum ST and the patient's thyroid cartilage TH. The ansa cervicalis AC, and related branches emanating from the ansa cervicalis AC, enervate the omohyoid muscle OHM, the sternohyoid muscle SHM, and the sternothyroid muscle STM. The ansa cervicalis AC can also extend at least partially parallel to and / or around the patient’s internal jugular vein IJV. FIG. IB also illustrates the patient's mandible M, mylohyoid muscle MLH, and digastric muscle DG (more specifically, the anterior belly of the digastric muscle DG), as well as the sternothyroid muscle STM, sternocleidomastoid muscle SCM, and the sternohyoid muscle SHM. The sternohyoid muscles SHM and the sternothyroid muscles STM extend over (e.g., anterior to) the patient’s larynx L. The muscles described above are contained within the patient's oral cavity OC, neck N, and / or shoulder SH. As described in greater detail below, by positioning and activating minimally invasive electrodes at least proximate to one or more the foregoing neural structures and / or associated musculature, embodiments of the present technology can control, reduce, and / or eliminate the effects of OSA.

[0041] FIG. 1C is a partially schematic illustration of representative neural structures and musculature of the patient's lower jaw and neck. The ansa cervicalis nerve AC includes a superior root SR, an inferior root IR, a first branch Bl innervating a superior belly of the omohyoid muscle OHMs and a superior belly of the sternohyoid muscle SHMs, a second branch B2 innervating an inferior belly of the omohyoid muscle OHMi, and a third branch B3 to both the sternohyoid muscle SHM and the sternothyroid muscle STM. More specifically, the third branch B3 can bifurcate / split into a first sub-branch B3a innervating the sternothyroid muscle STM and a second sub-branch B3b innervating an inferior belly of the sternohyoid muscle SHMi. The hypoglossal nerve HGN, cranial nerves C1-C3, internal jugular vein IJV, and common carotid artery CCA are also shown for context. Details regarding the various ansa cervicalis phenotypes can be found, for example, at least in U.S. Pat. No. 12,246,175, filed on March 15, 2024, the entirety of which is hereby incorporated by reference herein.

[0042] FIG. 1C also shows the patient’s hypoglossal nerve HGN, including the medial branch MB of the hypoglossal nerve HGN and the anterior branches AB of the hypoglossal nerve HGN. The anterior branches AB include the distal arborizing portions of the HGN, such as the motor points, motor end plates, and / or neuromuscular junctions of the HGN that insert into the genioglossus muscle GG. In some patients, one or more of the anterior branches AB include a plurality of distal brachiated portions or distal branches that innervate the patient’s -10- 184268789.1Attomey Docket No.: 132368.8037.WO00genioglossus muscle GG. By positioning and activating minimally invasive electrodes positioned proximate to the foregoing neural structures and / or associated musculature, Additional details regarding the modulation therapies associated with the anterior branches AB of the hypoglossal nerve can be found, for example, at least in U.S. Pub. No. 2024 / 0207613, filed on December 21, 2023, the entirety of which is hereby incorporated by reference herein.

[0043] Several target tissues are described and / or illustrated with reference to FIGS. 1 A-1C. For the purpose of illustrative clarity, these target tissues and implantation techniques are shown with reference to a left or right side of the patient anatomy. It will be appreciated, however, that at least some or all of the target tissues described and / or illustrated with reference to FIGS. 1A-1C are equally suitable for application to the other side of the patient’s anatomy. Additionally, at least some of the target tissues and / or implantation techniques can be used for bilateral signal delivery, for example, to apply a first electrical signal to a first target tissue on a first side of the patient and to apply a second electrical signal to a second target tissue on a side of the patient at a same or different time. The second electrical signal can be the same or different than the first electrical signal. In some embodiments, the first and second target tissues can be corresponding left and right portions of the patient’s anatomy, such as first and second portions of the left and right hypoglossal nerves. In other embodiments, the first and second target tissues can be different, such as a portion of the ansa cervicalis nerve on a left side of the patient and a portion of the hypoglossal nerve on a right side of the patient.3. Modulation Therapy System and Associated Sleep Apnea Treatment Devices

[0044] FIG. 2A is a partially schematic illustration of a modulation therapy system 100 (“the system 100”) configured in accordance with embodiments of the present technology. The system 100 can include one or more implantable devices 101. The implantable devices 101 can include one or more signal delivery devices 102 (individually identified as first and second signal delivery devices 102a and 102b, respectively) and an implantable pulse generator 104 (“IPG 104”).

[0045] The signal delivery devices 102 can include one or more electrodes, one or more electrode arrays, and / or one or more other devices configured to deliver one or more modulation signals to the patient P, e.g., including to any one or more of the nerves, muscles, and / or other target tissues described herein. Each of the signal delivery devices 102 can include a lead 106 (individually identified as a first lead 106a and a second lead 106b) configured to be coupled (e.g., operably coupled) to the IPG 104. The signal delivery devices 102 and / or the-11- 184268789.1Attomey Docket No.: 132368.8037.WO00leads 106 can be configured to be positioned with the patient P via a percutaneous injection and / or other minimally-invasive implantation techniques, including the minimally-invasive implantation techniques described herein. The signal delivery devices 102 can be implanted as part of a same procedure or different procedures. The first signal delivery device 102a can be positioned to deliver modulation signals to a first target tissue and the second signal delivery device 102b can be positioned to deliver modulation signals to a second target tissue, different than the first target tissue. For example, in the illustrated embodiment, the first signal delivery device 102a is positioned to deliver one or more first modulation signals to the anterior branches AB of the patient’s hypoglossal nerve HGN and the second signal delivery device 102b is positioned to deliver one or more second modulation signals to a branch of the ansa cervicalis AC that innervates both the sternohyoid and sternothyroid muscles. In some embodiments, the first signal delivery device 102a is implanted after the second signal delivery device 102b based at least in part on a determination that ansa cervicalis modulation alone is insufficient to address the patient’s breathing obstructions. In other embodiments, the second signal delivery device 102b is implanted after the first signal delivery device 102a based at least in part on a determination that hypoglossal nerve modulation alone is insufficient to address the patient’s breathing obstructions. The signal delivery devices 102 can be positioned within the patient P using respective insertion paths, although those of ordinary skill in the art will appreciate that one or both of the signal delivery devices 102 can be positioned in other orientations and / or using other insertions paths to modulate the target tissues. Additional details regarding signal delivery device insertion paths and orientations can be found in U.S. App. No.18 / 393,537, filed December 21, 2023, and U.S. Pat. No. 12,246,175, filed March 15, 2024, each of which is hereby incorporated by reference herein.[0046| The first signal delivery device 102a and / or the second signal delivery device 102b can be positioned to modulate one or more other target tissues described and / or illustrated herein. For example, the first signal delivery device 102a can be positioned to deliver the first modulation signals to any one or more of the medial branch of the hypoglossal nerve, the genioglossus muscle directly, the inferior root of the ansa cervicalis, the superior root of the ansa cervicalis, one or more of the branches of the ansa cervicalis, one or more of the motor points of the ansa cervicalis, the omohyoid muscle, the sternohyoid muscle, the sternothyroid muscle, the thyrohyoid muscle, combinations thereof, and / or other target tissues described herein. Additionally, or alternatively, the second signal delivery device 102b can be positioned to deliver the second electricals signals to any one or more of the medial branch of the-12- 184268789.1Attomey Docket No.: 132368.8037.WO00hypoglossal nerve, one or more of the anterior branches of the hypoglossal nerve, the genioglossus muscle directly, the inferior root of the ansa cervicalis, the superior root of the ansa cervicalis, one or more of the branches of the ansa cervicalis, one or more of the motor points of the ansa cervicalis, the omohyoid muscle, the sternohyoid muscle, the sternothyroid muscle, and / or the thyrohyoid muscle, combinations thereof, and / or other target locations described herein. In these and / or other embodiments, the signal delivery devices 102 can be positioned to bilaterally stimulate respective tissues on the left and right side of the patient, e.g., the left hypoglossal nerve and the right ansa cervicalis nerve, the left thyrohyoid muscle and the right genioglossus muscle, etc.[00471 The IPG 104 can include one or more pulse generators configured to generate the one or more modulations signals delivered by the signal delivery devices 102, and can also include an onboard power source (e.g., a battery, a supercapacitor, etc.) configured to power the modulation signal generation by the pulse generator. The IPG’s onboard power source can, periodically, be charged wirelessly, e.g., by a wireless charging unit. The IPG 104 can be implanted separately from one or more of the signal delivery devices 102 and / or the leads 106. For example, the signal delivery devices 102 and at least a corresponding portion of the leads 106 can be implanted (e.g., percutaneously injection) in a first location, the IPG 104 can be implanted (e.g., percutaneously implanted) in a second location different / spaced from the first location, and then the leads 106 can be tunneled between the signal delivery devices 102 and the IPG 104 to operably couple these components.

[0048] The system 100 can further include an external device 110 and / or a programmer 120. The external device 110 can, e.g., remain external to the patient P while in use. In at least some embodiments, for example, the external device 110 has a wearable form factor and can be or include a collar, chinstrap, and / or other suitable wearable. In these and / or other embodiments, the external device 110 can be or include one or more handheld devices, software applications (e.g., tablet and / or mobile device-downloadable apps), pillows, pillow cases, mattress toppers, mats, bedside devices, and / or one or more other suitable external devices. In these and / or other form factors, the external device 110 can include one or more controllers 112, one or more sensors 114, and / or one or more communication components 116.

[0049] The one or more controllers 112 can include one or more non-transitory, computer-readable media (e.g., computer-readable memory) configured to store computerexecutable instructions and / or one or more processors configured to execute the instructions stored on said computer-readable media, e.g., to cause the external device 110 and / or one or -13- 184268789.1Attomey Docket No.: 132368.8037.WO00more of the components thereof to perform one or more operations, including any of the operations described herein. The one or more sensors 114 can be configured to obtain information related to the patient P and / or the modulation therapy provided by the system 100. The one or more sensors 114 can include a single sensor, an array of sensors, and / or other suitable sensor arrangements configured to collect data associated with a patient. Although illustrated as being part of the external device 110 in FIG. 2 A, those of ordinary skill in the art will appreciate that one or more of the sensors 114 can be individual components of the system 100 that are separate from the external device 110, such as a separate external heart rate monitor and / or one or more other separate sensors and / or sensing devices. The one or more controllers 112 can be operably coupled to and / or otherwise configured to obtain data (e.g., data associated with a patient’s sleep apnea and / or obstructed breathing) via the sensors 114. Based at least in part on the data obtained via the sensors 114, the one or more controllers 112 can be configured to adjust the operation of one or more other components of the external device 110 and / or the IPG 104. The one or more communication components 116 can be configured to exchange (e.g., send and / or receive) one or more communications signals 118 with the IPG 104 and / or the programmer 120, directly or via a wired and / or wireless network 122 (e.g., the Internet, the cloud, etc.) and / or other communication channel (e.g., Bluetooth, cellular, fiber optic, and / or combinations thereof).[0050| The programmer 120 can include a patient-operated programmer and / or a clinician-operated programmer and can be configured to control one or more characteristics of the modulation signal delivered to the patient. In a representative embodiment, the programmer 120 can include a therapy adjustment module configured to select one or more of the signal delivery devices 202 and adjust an amplitude, frequency, pulse width, burst duration, whether the electrode is active or inactive, and / or any other suitable signal delivery parameter. In at least some embodiments, the programmer 120 can transmit instructions for generating a modulation signal (e.g., signal delivery or waveform parameters) to the external device 110, the external device 110 can transmit the instructions to the IPG 104, and one or more of the pulse generators within the IPG 104 can generate one or more modulation signals according to the transmitted instructions and apply the modulation signal to a patient via one or more of the signal delivery devices 102. Additionally, the programmer 120 can synthesize information (e.g., diagnostic and / or feedback information) received from a user, the external device 110, and / or one or more of the implantable devices 101 and can adjust one or more of the signal delivery parameters based at least partially on the synthesized information. For example, the-14- 184268789.1Attomey Docket No.: 132368.8037.WO00programmer 120 can be configured to (i) receive one or more inputs corresponding to a patient’s perception threshold and / or arousal threshold and (ii) adjust an amplitude of a modulation signal delivered to the patient based, at least in part, on the patient’s perception threshold and / or arousal threshold. Additionally, or alternatively, the programmer 120 can (i) generate a dose-response curve that plots Apnea-Hypopnea Index (AHI) against modulation amplitude and (ii) use the dose-response curve to adjust or recommend adjustments to the amplitude of the modulation signal delivered to the patient.

[0051] The programmer 120 can communicate with the IPG 104 directly and / or via the network 122 and / or the external device 110. For example, the programmer 120 can be connected to the IPG 104 and / or the external device 110 via a wired or wireless communication link, including WiFi, Bluetooth, cellular connectivity, and / or any other suitable communication link. In these and other embodiments, the programmer 120 can be connected to the network 122 and / or other computer service to, e.g., upload data received from the sensors 114 and / or to download information to the external device 110 and / or the IPG 104. In these and other embodiments, the programmer 120 can include a display and / or a user interface. A user (e.g., the patient, the clinician, and / or other suitable user) can interact with and / or otherwise control one or more aspects of the programmer 120 via the user interface to, e.g., manually adjust one or more of the signal delivery parameters, to read data received from the sensors 114, provide one or more inputs corresponding to a tissue collapse pattern, and / or carry out other tasks. ]0052| FIG. 2B is a partially schematic illustration of the system 100 in accordance with additional embodiments of the present technology. In some embodiments, the IPG 104 (FIG. 2 A) can be omitted and the signal delivery devices 102 can instead be coupled to (or can be configured to be coupled to) one or more percutaneously implantable or injectable housings 108 (individually identified as a first housing 108a coupled to the one or more first signal delivery devices 102a and a second housing 108b coupled to the one or more second signal delivery devices 102b). Like the IPG 104 (FIG. 2A), each of the housings 108 can include one or more pulse generators configured to generate the modulations signals delivered by the respective signal delivery devices 102. However, unlike the IPG 104, the housings 108 may rely on wirelessly-provided energy to power their respective pulse generators. In the illustrated embodiment, for example, the external device 110 further includes one or more power transmission devices 124 configured to wirelessly provide one or more power signals 126 to one or more power-receiving devices (e.g., RF antennas, inductive coils, etc.) contained within each of the housings 108. The housings 108 are expected to be less invasive to implant than -15- 184268789.1Attomey Docket No.: 132368.8037.WO00the IPG 104 (FIG. 2 A) and, in at least some embodiments, can be configured to be implanted within a patient via a percutaneous injection, e.g., using the same injection tool used to implant the leads 106. The leads 106 can connect (e.g., operably connect) the one or more signal delivery devices 102 to the respective housings 108. Accordingly, the one or more first signal delivery devices 102a, the first lead 106a, and the first housing 108a can at least partially define a first implantable sleep apnea treatment device 101a and the one or more second signal delivery devices 102b, the second lead 106b, and the second housing 108b can at least partially define a second implantable sleep apnea treatment device 101b (referred to collectively as “implantable device 101” or “implantable devices 101”).[0053| Each of the housings 208 can include one or more power receiving devices (e.g., one or more RF antennas, inductive coils, etc.) configured to receive power from the one or more power transmission devices 124 and one or more pulse generators configured to use power from the power transmission devices 124 to generate one or more modulation signals for delivery via one or more of the signal delivery devices 102. When implanted, all or a subset of the housings 208 can be positioned in a same or similar location as the IPG 104 (FIG. 2 A), such as shown in FIG. IB, or can be positioned closer to the corresponding signal delivery devices 102, such as within the patient’s neck and / or lower jaw. The housings 108 can be implanted with the signal delivery devices 102, or can be implanted separately and then connected to the signal delivery devices 102.[0054| In some embodiments, one or more of the housings 108 are passive devices that do not include an onboard pulse generator configured to generate modulation signals. Instead, the passive housing can wirelessly receive a power signal from the external device 110 and transmit the received power signal to the wearer via one or more of the signal delivery devices 102. The passive signal delivery device may condition or otherwise process the received power signal but not, e.g., use the received power signal to power an onboard pulse generator and / or store the receive power for use long-term and / or in the absence of externally-supplied power.

[0055] The leads 106, the controllers 112, the sensors 114, the communication components 116, and the programmer 120 can be configured to operate in a manner that is at least generally similar or identical to the description provided with reference to at least FIG. 2A. In at least some embodiments, for example, the controllers 112 can include one or more algorithms and / or other machine-readable instructions that, based at least partially on data obtained via one or more of the sensors 114, are configured to (i) initiate power delivery to the first housing 108a and / or the second housing 108b, (ii) halt power delivery to the first -16- 184268789.1Attomey Docket No.: 132368.8037.WO00housing 108a and / or the second housing 108b, and / or (iii) select one or more signal delivery parameters (e.g., frequency, amplitude, pulse width, duty cycle, interpulse spacing, and / or combinations thereof) for a modulation signal to be delivered to the patient via the one or more first signal delivery devices 102a and / or the one or more second signal delivery devices 102b. In some embodiments, the programmer 120 can be configured to communicate with the housings 108 and / or one or more of the components contained therein, e.g., directly, via the network 122, and / or otherwise without using the external device 110 as an intermediary.

[0056] Referring to FIGS. 2 A and 2B together, individual ones of the sensors 114 can be configured to collect data associated with the patient, such as data associated with the patient’s sleep state and / or respiratory performance. Representative data that can be obtained via one or more of the sensors 114 includes respiratory rate, sleep state, wake state, heart rate, audio signals (corresponding to audible snoring, hypopnea events, and / or apnea events), body temperature, head orientation / position, saturated blood oxygen levels, air flow levels, thyroid movement, trachea movement, tongue movement, photoplethysmography (PPG) data, and / or combinations thereof. Each of the foregoing types of data can be received by a corresponding type of sensor (e.g., heart rate data via a heart rate sensor, head orientation / position data via an accelerometer, body temperature from a temperature sensor, audio signals from a microphone or other audio sensor, etc.), and can correspond to a measure of the patient’s respiratory performance, sleep state, wake state, and / or other suitable metrics, including metrics that are used to rate the patient on the Apnea-Hypopnea Index (AHI).

[0057] In at least some embodiments, for example, the one or more controllers 112 can include one or more algorithms and / or other machine-readable instructions that, based at least partially on data obtained via one or more of the sensors 114, are configured to (i) initiate modulation signal delivery to the first signal delivery device 102a and / or the second signal delivery device 102b, (ii) halt modulation signal delivery to the first signal delivery device 102a and / or the second signal delivery device 102b, and / or (iii) select one or more signal delivery parameters (e.g., frequency, amplitude, pulse width, duty cycle, interpulse spacing, and / or combinations thereof) for a modulation signal to be delivered to the patient via the first signal delivery device 102a and / or the second signal delivery device 102b. In a representative embodiment, the one or more controllers 112 can include sleep tracking, respiratory diagnostics, and / or therapy modulation algorithms configured to select, adjust, and / or otherwise control one or more of the delivery parameters for the modulation signals based at least partially on data, obtained via one or more of the sensors 114, that is associated with the -17- 184268789.1Attomey Docket No.: 132368.8037.WO00patient’s sleep state and / or respiratory performance. The obtained data can include data associated with the patient’s sleep state and / or respiratory performance before the delivery of any modulation signals and / or data obtained during and / or after the delivery of one or more modulations signals.[0058| The signal delivery devices 102 can be configured to deliver modulation signals having the same or one or more different signal delivery parameters (e.g. amplitude, frequency, pulse width) to, e.g., optimize the patient’s airflow response or efficacy for each respective target location. For example, individual ones of the signal delivery parameters can be determined based, at least in part, on the patient’s measured airway flow response or one or more other physiologic inputs from an external wearable or another device configured to detect the patient’s airway flow response. Additionally, or alternatively, one or more signal delivery parameters of the modulation signals delivered by each of the signal delivery devices 102 can vary based, at least in part, on the respective locations and / or target tissues of each signal delivery device 102.[00591 In some embodiments, one or more of the signal delivery parameters of the modulation signal delivery by each signal delivery device 102 can be adjusted or modulated during delivery in, e.g., a closed loop or an open loop manner. For example, the adjustments / modulations to the signal delivery parameters can compensate for movement of each signal delivery device 102 relative to their respective target locations after implantation, which can be caused by movement of the patient and / or one or more changes in a patient’s body position. Additionally, the adjustments / modulations to the signal delivery parameters can compensate for one or more changes in the patient’s sleep stage, data associated with an efficacy of the modulation therapy (e.g., air flow, respiratory effort), etc.

[0060] In some embodiments, each of the signal delivery devices 102 can be activated independently, such that a subset of the one or more signal delivery devices 102 can be active while others of the signal delivery devices 102 are inactive. Each signal delivery device 102 can alternate between active / on and inactive / off states independently for selected periods, such as very short durations (e.g., 100 msec) or longer durations (e.g., 10 seconds). For example, in some embodiments, an ON-OFF modulation pattern can be programmed to regularly alternate between the signal delivery devices 102. For example, the first signal delivery device 102a can be ON (e.g., receiving power and / or delivering modulation signals) for a first time period (e.g., at least 1 second, 2 seconds, 3 seconds, 4 seconds, 5 seconds, etc.), followed by the second signal delivery device 102b being ON for a second time period (e.g., at least 1 second, 2-18- 184268789.1Attomey Docket No.: 132368.8037.WO00seconds, 3 seconds, 4 seconds, 5 seconds, etc.). In some embodiments, the first time period and / or the second time period can be randomly selected. In some embodiments, the first signal delivery device 102a can be OFF (e.g., not receiving power and / or not delivering modulation signals) when the second signal delivery device 102b is ON and / or vice versa, and / or delivery of the modulation signals can be concurrent for a portion of the modulation pattern. In other embodiments, both the first and second signal delivery devices 102a, 102b can be ON and OFF at the same, or at least generally the same, times. In further embodiments, the times during which a given signal delivery device 102 is ON or OFF can be randomized. In some embodiments, after at least one of the signal delivery devices 102 has completed an ON interval, that signal delivery device 102 can remain OFF for an OFF interval. The OFF interval can be up to 1 minute, 2 minutes, 3 minutes, 4 minutes, 5 minutes, 10 minutes, etc. The OFF interval can also vary over time, can be randomly selected, and / or include one or more other suitable durations of time.[00611 In some embodiments, individual electrodes of each signal delivery device 102 can be activated or deactivated to direct delivery of the modulation signal toward the respective target location and / or to adjust the electrical field generated to deliver the modulation signal (e.g., narrow or widen the electrical field). For example, if the signal delivery devices 102 include quadripolar electrodes arrays having four electrodes, using the middle two (e.g., second and third) electrodes can create a field that is narrower than, e.g., using the outer two (e.g., first and fourth) electrodes.

[0062] In some embodiments, a cyclic modulation pattern can be programmed to regularly alternate one or more parameters of the signals delivered by the signal delivery devices 102. The amplitude, pulse width, and / or frequency can be programmed to be changed regularly at programmed time intervals, in response to sensed data, randomly, irregularly, etc. The cyclic modulation pattern can include, for example, 1.0 mA for 1 second, then 2.0 mA for 1 second, and then 1.0 mA for 1 second for a duration of 3 seconds of modulation. Another example cyclic modulation pattern includes 0.5 mA for 1 second, then 1.0 mA for 1 second, and then 0.5 mA for 1 second for a duration of 3 seconds of modulation. Each of the signal delivery devices 102 can deliver their respective modulation signals at the same or different times as one or more other signal delivery devices 102, and / or the modulation signals can be delivered concurrently for a portion of the modulation pattern.

[0063] In some embodiments, an if-then modulation pattern can be programmed to respond to one or more specific physiologic measurements (e.g., air flow) detected or -19- 184268789.1Attomey Docket No.: 132368.8037.WO00determined by, e.g., one or more sensors of the signal delivery device, one or more sensors implanted within the patient, and / or a wearable or other external sensing device. For example, the external device 110 can turn ON at least one of the signal delivery devices 102. If the patient’s physiologic response is insufficient, as determined based at least in part on the one or more physiological measurements, the external device 110 can turn on one or more other signal delivery devices 102 so that the ON signal delivery devices are operating simultaneously. Additionally, or alternatively, one or more parameters of the respective signals delivered by the signal delivery devices 102 can be adjusted (e.g., as described herein) in response one or more of the physiological measurements.[0064 | In some embodiments, the signal delivery devices 102 can be programmed with phase manipulation patterns. For example, the amplitude of the modulation signal delivered by the signal delivery devices 102 can ramp up and down during a modulation interval in a sine wave shape. In some embodiments, the modulation signal delivered by one of the signal delivery devices 102 can have a phasing pattern in phase or 180° out of phase with the modulation signal delivery by one or more of the other signal delivery devices 102. In at least some embodiments, two or more signal delivery devices 102 can be programmed to create a phase inversion via delivery of their respective modulation signals. In some embodiments, the modulation signal can be a square wave and can be ramped in a stepwise fashion, e.g., from a first pulse to a second pulse.[0065J FIG. 2C is a side view of a signal delivery device 202 configured in accordance with embodiments of the present technology. The signal delivery device 202 can be at least generally similar or identical in structure and / or function to one or more of the signal delivery devices 102 described elsewhere herein, including with reference to FIGS. 2A and 2B. In the illustrated embodiment, for example, the signal delivery device 202 includes a lead 206 and plurality of electrodes 228 (individually identified as first electrode 228a, second electrode 228b, third electrode 228c, and fourth electrode 228d) carried by and / or otherwise coupled to the lead 206. All or a subset of the electrodes 228 can extend at least partially or entirely around a circumference of the lead 206. In some embodiments, all or a subset of the electrodes 228 are segmented and / or masked, e.g., to include multiple electrode portions that each extend partially around a circumference of the lead 206.

[0066] The signal delivery device 202 can further include one or more anchoring devices or fixation features 230 (individual identified as a first or distal fixation feature 230a and a second or proximal fixation features 230b). Each of the fixation features 230 can include a -20- 184268789.1Attomey Docket No.: 132368.8037.WO00fixation body 232 and one or more arms or fins 234 extending outwardly (e.g., radially outwardly) therefrom. In the illustrated embodiment first fixation feature 230a is coupled to the lead 206 at a location distal to the electrodes 228, e.g., between the electrodes and a distal terminus 207 of the lead 206, and the second fixation feature 230b is coupled to the lead 206 at a location proximal to the electrodes 228. In these and / or other embodiments, one or more of the fixation features 230 can be coupled to the lead 206 at one or more other suitable positions, such as positions that are more proximal and / or more distal than the positions illustrated in FIG. 2C and / or that are between individual ones of the electrodes 228.

[0067] FIG. 2D is an distal end view of the signal delivery device 202. As best seen in FIG. 2D, the first fixation features 230a can include primary, secondary, and tertiary first fins 234ai-3 and the second fixation feature 230b can include primary, secondary, and tertiary second fins 234bi-3. All or a subset of the first fins 234a can be oriented to define a first interior angle Al therebetween (e.g., of up to 10 degrees, 20 degrees, 30 degrees, 40 degrees, 45 degrees, 60 degrees, 90 degrees, 180 degrees, any angle therebetween, and / or combinations thereof). Additionally or alternatively, all or a subset of the second fins 234b can be oriented to define the first interior angle Al. In these and / or other embodiments, the first fins 234a can be rotationally offset from the second fins 234b, e.g., to define a second interior angle A2 therebetween (e.g., of up to 10 degrees, 20 degrees, 30 degrees, 40 degrees, 45 degrees, 60 degrees, 90 degrees, 180 degrees, any angle therebetween, and / or combinations thereof). In some embodiments the second interior angle A2 is less than (e.g., half of) the first interior angle A2.|0068] All or a subset of the fins 234 can be configured to transition between a deployed configuration (e.g., such as shown in FIG. 2D) and a delivery configuration in which the fins 234 can wrap around (e.g., at least partially around) the fixation body 232, e.g., to reduce the cross-sectional profile of the signal delivery device 202. The fins 234 can be held in this position at least partially by an introducer or other cannula. When one of the fixation features 230 is positioned external to the introducer, the fins 234 of that fixation feature can bend / flex outwardly from the corresponding fixation body 232 into the delivery configuration, e.g., as shown in FIG. 2D. In the delivery configuration the fins 234 can engage surrounding tissue(s) to prevent, or at least partially prevent, the signal delivery device 202 from moving relative to the surrounding tissue. Accordingly, when the fins 234 are deployed at least proximate to target tissue, the fins 234 can prevent, or at least partially prevent, the signal delivery device 202 from moving relative to the target tissue, e.g., to allow the signal delivery device 202 to accurately -21- 184268789.1Attomey Docket No.: 132368.8037.WO00and / or consistently deliver one or more modulation signals to the target tissue to at least partially address the patient’s sleep apnea.4. Introducer System, Associated Devices, and Methods of Using the Same

[0069] FIG. 3 A is a side view of an introducer system 350 configured in accordance with embodiments of the present technology. FIG. 3B is a partially exploded view of the introducer system 350 of FIG. 3A. Referring to FIGS. 3A and 3B together, the introducer system 350 can include a delivery tool 352 and a dilator 354. The delivery tool 352 can include a handle portion 356 and a catheter or sheath 358 coupled to the handle portion 356 and extending outwardly therefrom, e.g., to a distal terminus 359. The sheath 358 can define a lumen 360 extending along (e.g., entirely along) the length of the sheath 358. In some embodiments, the sheath 358 can be textured, coated, and / or otherwise configured to improve its echogenic properties, e.g., to make the sheath 358 more hyperechoic and / or otherwise easier to visualize using ultrasound.[0070| The dilator 354 can include a handle 362 and an elongate shaft 364 coupled to the handle 362. The shaft 364 can include distal tip 366 that defines a distalmost terminus of the dilator 354. All or at least a portion of the shaft 364 can be configured to be received within the lumen 360. In the embodiment illustrated in FIG. 3A, for example, the shaft 364 is positioned within the lumen 360 with the distal tip 366 extending outwardly from the lumen 360 and distally beyond the sheath 358. In some embodiments, the shaft 364 of the dilator 354 can be textured, coated, and / or otherwise configured to improve its echogenic properties, e.g., to make the shaft 364 more hyperechoic and / or otherwise easier to visualize using ultrasound.

[0071] The delivery tool 352 and / or the dilator 354 can be configured to be electrically activatable. In the illustrated embodiment, for example, the delivery tool 352 includes one or more sheath electrodes 368 (three shown in FIG. 3A) carried by and / or otherwise coupled to the sheath 358 and configured to deliver one or more modulation signals, e.g., to a patient. The locations of individual ones of the sheath electrodes 368 can be selected or customized based on the needs of a given procedure. The one or more sheath electrodes 368 can be operably (e.g., electrically, conductively, etc.) coupled to an external pulse generator or other signal generator via, e.g., one or more electrical connectors 370 (individually identified as a first, second, and third connectors 370a-c, respectively). The signal generator can be, for example, a Stimuplex® HNS 12 Peripheral Nerve Stimulator manufactured by B. Braun Medical Inc., headquartered in Melsungen, Germany, or one or more other suitable signal generators.-22- 184268789.1Attomey Docket No.: 132368.8037.WO00

[0072] In some embodiments, the shaft portion 364 of the dilator 354 (e.g., the distal tip 366 thereof) can include an electrically-activatable tip 372 (e.g., a tip electrode) configured to deliver one or more modulation signals, e.g., to the patient. The location and / or dimensions of the electrically-activatable tip 372 can be selected or customized based on the needs of a given procedure. The electrically-activatable tip 372 can be operably (e.g., electrically, conductively, etc.) coupled to a same or different signal generator as the one or more sheath electrodes 368 via, e.g., a respective electrical connector 374. In some embodiments, the electrically-activatable tip 372 is configured to be used as a return electrode for the one or more sheath electrodes 368 carried by the sheath 358. In these and / or other embodiments, the one or more sheath electrodes 368 can be configured to be used as a return electrode for the electrically-activatable tip 372 . The electrically-activatable tip 372 can be positioned distally beyond the distal terminus 359 of the sheath 358 when the shaft portion 364 of the dilator 354 is received within the lumen 360 of the delivery tool 352. In the illustrated embodiment the electrically-activatable tip 372 is pointed and, e.g., configured to pierce the patient’ s skin and / or other tissue to form an opening therethrough to facilitate percutaneous access to the target tissue. In other embodiments, the electrically-activatable tip 372 can be blunt, atraumatic, and / or have other geometries configured to facilitate insertion (atraumatic or otherwise) through skin or tissues. In some embodiments, configuring the electrically-activatable tip 372 to be atraumatic is advantageous because doing so can minimize, or even prevent, trauma to the target tissue and / or other structures (e.g., nerves, glands, vessels, etc.) surrounding the target tissue and that need to be safely navigated around / past to place a signal delivery device at least proximate to the target tissue.[0073| The delivery tool 352 and the dilator 354 can be configured to be coupled (e.g., releasably coupled) together to prevent, or at least partially prevent, the delivery tool 352 and the dilator 354 from moving relative to one another. For example, as best seen in FIG. 3B, the delivery tool 352 can include one or more first coupling features 376, the dilator 354 can include one or more second coupling features 378, and the one or more first coupling features 376 can be configured to be coupled (e.g., releasably coupled) to the one or more second coupling features 378 and thereby couple the delivery tool 352 to the dilator 354. In the illustrated embodiment, the one or more first coupling features 376 include a threaded passageway 380 and the one or more second coupling features 378 include threading or grooves 382 configured to be received within the threaded passageway 380, e.g., by rotating the threading 382 into engagement with the threaded passageway 380. In these and / or other-23- 184268789.1Attomey Docket No.: 132368.8037.WO00embodiments, the one or more first coupling features 376 can include one or more slots and / or other suitable coupling features, and / or the one or more second coupling features 378 can include one or more tabs and / or other suitable coupling features. For example, the first and second coupling features 376, 378 can be configured to engage via a press-fit / snap coupling mechanism and / or a bayonet twist-lock coupling mechanism.

[0074] During a signal delivery device insertion procedure, a user (e.g., a physician or other practitioner) can advance the delivery tool 352 and the dilator 354 together toward a target tissue of a patient. In some embodiments, the physician can advance the delivery tool 352 and the dilator 354 under ultrasound and / or other guidance. When the user believes the distal tip 366 is at least proximate to the target tissue, the user can deliver one or more modulation signals to the patient via the sheath electrodes 368 and / or the electrically-activatable tip 372 and, e.g., observe and / or measure the patient’s response to the one or more modulation signals. Based at least in part on the observed and / or measured patient response (e.g., motor response, response magnitude, etc.) to the delivered modulation signal(s), the user can determine whether or not the one or more sheath electrodes 368 are positioned at least proximate to the target tissue. When the user observes that the patient’s response to the one or more modulations signals is as desired (e.g., the one or more modulation signals cause a muscle associated with a target nerve to twitch), the user can, while maintaining a position and / or an orientation of the delivery tool 352 relative to the patient, remove the dilator 354 from the delivery tool 352 and advance a signal delivery device through the delivery tool 352 so that an electrode array of the signal delivery device is positioned at least proximate to the target tissue. If the patient’s response to the one or more modulation signals is not the desired response (e.g., is less or greater than the desired response, or differs from the desired response by a predetermined percentage), the user can reposition and / or reorient the delivery tool 352 and / or the dilator 354 and observe the patient’s response to one or more modulation signals delivered from this new position and / or orientation. In some embodiments, the user can deliver the one or more modulation signals while repositioning and / or reorienting the delivery tool 352 and / or the dilator 354. Once the patient’s response to the one or more modulation signals is as desired, the user can uncouple the dilator 354 from the delivery tool 352 and remove the dilator 354 from the lumen 360, e.g., to allow the user to implant one or more signal delivery devices within the patient through the lumen 360.

[0075] Although it is believed that using visual-based guidance (e.g., ultrasound) in combination with modulation response based-guidance to place the signal delivery device 302-24- 184268789.1Attomey Docket No.: 132368.8037.WO00as described herein can improve the speed and / or accuracy with which a user can place the signal delivery device at least proximate to the target tissue, in some circumstances the user may be able to place the signal delivery device solely using visual-based guidance (e.g., based on visualizing relevant anatomical landmarks proximate the target tissue), solely using modulation response-based guidance (e.g., by observing the patient’s response to delivered modulation), or without the aid of either of these forms of guidance. Accordingly, embodiments of the present technology can include using the delivery tool 352 to place the signal delivery device 302 at least proximate to the target tissue as described herein, and doing so with or without the aid of visual-based guidance and / or modulation response based-guidance.[0076| FIG. 3C is a side view of an electrode array 384 positioned within the lumen 360 of the sheath 358 after, e.g., the dilator shaft 364 (FIGS. 3A and 3B) has been removed from within the lumen 360, in accordance with embodiments of the present technology. The sheath 358 is shown in cross-section for illustrative clarity. The electrode array 384 can be a portion of a signal delivery device 302 carried by a lead 306 and configured to be implanted within the patient. The signal delivery device 302 and / or the lead 306 can be at least generally similar or identical in structure and / or function to one or more of the signal delivery devices 102, 202 and / or the leads 106, 206 described elsewhere herein, including with reference to FIGS. 2A-2D. The electrode array 384 can include a plurality of array electrodes 386 (four shown in FIG.3C), individual ones of which can be configured to deliver one or more modulation signals to the patient.

[0077] While the signal delivery device 302 is positioned within the sheath 358, the electrode array 384 can be at least partially aligned with (e.g., beneath, radially inwardly from, etc.) the one or more sheath electrodes 368 carried by the sheath 358. In the illustrated embodiment, for example, one or more (e.g., 3 out of 4) of the array electrodes 386 in the electrode array 384 are aligned with (e.g., positioned radially inwardly from) a corresponding one of the sheath electrodes 368. When the sheath electrodes 368 and the array electrodes 386 are at least partially aligned, the user can deliver one or more modulation signals via the one or more sheath electrodes 368 to confirm that the patient’s response to the one or more modulations signals is as desired. When confirmed, the user can withdraw the sheath 358 over the signal delivery device 302 while, e.g., maintaining a position of the signal delivery device 302 relative to the target tissue. In so doing, the electrode array 384 is expected to have the same, or an at least substantially similar, position and / or orientation relative to the target tissue as the one or more sheath electrodes 368 carried by the sheath 358. This, in turn, is expected to -25- 184268789.1Attomey Docket No.: 132368.8037.WO00increase the accuracy with which the user can position the electrode array 384 relative to the target tissue. Moreover, aligning the electrode array 384 with the one or more sheath electrodes 368 carried by the sheath 358 and then confirming that the patient’s response to a modulation signal delivered via the one or more sheath electrodes 368 is as desired is expected to increase the likelihood that the electrode array 384 will also produce a desired patient response when the signal delivery device 302 is implanted in the same or an at least substantially similar position and / or orientation relative to the target tissue as the one or more sheath electrodes 368.

[0078] In some embodiments, the signal delivery device 302 can include a first or distal fixation feature 330a and a second or proximal fixation feature 330b, each of which can be at least generally similar or identical in structure and / or function to the fixation features 330 described elsewhere herein, including with reference to FIGS. 2C and 2D. The first fixation feature 330a can be positioned distal to the electrode array 384 and the second fixation feature 330a can be positioned proximal to the electrode array 384. When the signal delivery device 302 is positioned within the lumen 360 and the sheath electrodes 368 and the array electrodes 386 at least partially aligned, the second fixation feature 330b can be positioned within the lumen 360 and the first fixation feature 330a can be positioned external to the lumen 360, e.g., distally beyond the distal terminus 359 of the sheath 358, and transition to a deployed configuration to engage patient tissue and at least partially prevent the electrode array 384 from moving relative to the target tissue. Positioning the second fixation feature 330b distal from the sheath 358 to engage tissue(s) of the patient when the array electrodes 386 are aligned with the sheath electrodes 368 is expected to allow a user to more accurately place the array electrodes 386 relative to the target tissue. For example, once the user has identified a target implant location and / or orientation using the sheath electrodes 368, the user can positioned the array electrodes 386 in the same or an at least substantially similar location and / or orientation by aligned individual ones of the array electrodes 386 with corresponding ones of the sheath electrodes 368. Deploying the second fixation feature 330b to engage patient tissue(s) when the array electrodes 386 are aligned with the sheath electrodes 368 can at least partially prevent the array electrodes 386 from moving relative to the target tissue and / or otherwise shifting away from the target implant location and / or orientation. After deploying the second fixation features 330b, the user can withdraw the sheath 358 proximally to expose the electrode array 384 to allow the user to confirm that the electrode array 384 is positioned as intended (e.g., at least proximate to target tissue) and, once confirmed, the sheath 358 can be withdrawn further proximally to uncover the second fixation feature 330b to allow the second fixation features-26- 184268789.1Attomey Docket No.: 132368.8037.WO00330b to transition to a deployed configuration in which it engages patient tissue at least partially prevent (e.g., further prevent) the electrode array 384 from moving.

[0079] FIG. 3D is a side view of a lead recapture tool 340 (LRT 340) configured in accordance with embodiments of the present technology. The LRT 340 can include a handle 342, a shaft 344 coupled to and extending from (e.g., distally from) the handle 342, and a lumen 346 extending through (e.g., entirely through) the handle 342 and the shaft 344. The shaft 344 can include or define one or more capture features 348 configured to operably engage one or more lead fixation features (e.g., one or more of the fixation features 230 of FIGS. 2C and 2D and / or one or more of the fixation features 330 of FIG. 3C) to facilitate transitioning the fixation features from an extended or deployed configuration (e.g., such as shown in FIG. 2D) toward and / or to a folded or delivery configuration. In the illustrated embodiment, for example, the capture features 348 include notches or V-shaped recesses formed in the distal terminus of the shaft 344. The LRT 340 can be advanced over a lead (e.g., one of the leads 106 of FIG. 2A, one of the leads 206 of FIG. 2B, and / or the lead 306 of FIG. 3C) until the capture features 348 are in contact with one or more of the lead’s fixation features. For example, a proximal end of the lead can be placed in the lumen 346 and fed through the shaft 344 and the handle 342, and the LRT 340 can be advanced distally over the lead (and / or the lead can be pulled proximally through the lumen 346) until the capture features 348 are in contact with one or more of the lead’s fixation features, at which point the LRT 340 can be actuated (e.g., rotated relative to the lead) to cause the fixation features to transition (e.g., fold inwardly) from the extended or deployed configuration toward and / or to the folded or delivery configuration.

[0080] FIG. 4 is a flow diagram of a method 400 of using an introducer system, e.g., to address breathing obstructions in a patient in accordance with embodiments of the present technology. In some embodiments, the method 400 is used to implant one or more sleep apnea treatment devices configured to treat a patient’s OSA (and / or one or more other breathing obstructions) by delivering one or more modulation signals that (i) reduce or reverse the tissue collapse causing the patient’ s OS A (and / or the one or more other breathing obstructions) and / or (ii) stiffen one or more tissues associated with the tissue collapse. The method 400 can be performed with and / or by any embodiment of the systems and / or devices described herein, such as the introducer system 350 of FIGS. 3A and 3B and / or one or more of the components thereof (e.g., the delivery tool 352 and / or the dilator 354). In some embodiments, at least a subset of the method 400 can be performed by a physician, a practitioner, and / or other user. FIGS. 5A-5F are side views of the introducer system 350 of FIGS. 3A and 3B during different -27- 184268789.1Attomey Docket No.: 132368.8037.WO00stages of the method 400, in accordance with embodiments of the present technology. Individual ones of FIGS. 5A-5F are described below with reference to one or more blocks 402-410 of the method 400.

[0081] At block 402, the method 400 can include percutaneously inserting an introducer system into a patient such that at least a portion of the introducer system is at least proximate to a target tissue of the patient. For example, FIG. 5A shows the introducer system 350, including the dilator 354 and the delivery tool 352, positioned at least proximate to target tissue TT. The target tissue TT can include one or more of the nerves, muscles, and / or other tissues described herein.

[0082] Percutaneously inserting the introducer system into the patient can include percutaneously inserting the introducer system into the patient via an incision or other opening formed using a percutaneous or other minimally invasive insertion tool, such as a needle (e.g., a percutaneous injection needle), stylet, introducer, dilator, and / or trocar, without performing a dissection. The opening can have, for example, a diameter that is less than or equal to 6 mm, 5 mm, 4 mm, or another suitable diameter. For example, FIG. 5A shows the sheath 358 extending through an opening 588 in the patient P. The opening 588 can be formed in an underside of the patient’s jaw and / or at one or more other locations suitable for providing minimally invasive percutaneous access to the target tissue TT. In at least some embodiments, a tip of the dilator 354 is configured to form the opening 588, e.g., by piercing the patient’s skin. In other embodiments, the opening 588 can be an incision or other opening formed using a separate tool (e.g., a scalpel). In at least some embodiments, the opening 588 can be formed without, or substantially without, dissecting the patient’s tissue.

[0083] The introducer system 350 can be inserted into the patient percutaneously and along an insertion path extending toward and / or to, e.g., the target tissue. Representative target tissues and insertion paths are described herein, including with reference to FIGS. 1A-1C and 11 A-l ID. Additional details regarding target tissues and insertion paths can be found in U.S. App. No. 18 / 393,537, filed December 21, 2023 and U.S. Pat. No. 12,246,175, filed March 15, 2024, both of which are hereby incorporated by reference herein in their entireties.

[0084] In some embodiments, block 402 includes percutaneously inserting a dilator (e.g., the dilator shaft 364 of FIGS. 3A and 3B) and a delivery catheter (e.g., the sheath 358 of FIGS 3A and 3B) together. For example, as described previously herein with reference to FIG. 3B, the dilator shaft 364 and the sheath 358 can be coupled to one another via respective coupling-28- 184268789.1Attomey Docket No.: 132368.8037.WO00features 376, 338. In other embodiments, percutaneously inserting an introducer system into a patient includes percutaneously inserting a dilator (e.g., the dilator shaft 364 of FIGS. 3 A and 3B) and then advancing a delivery catheter (e.g., the sheath 358 of FIGS 3 A and 3B) distally over a shaft (e.g., the shaft 364 of FIGS. 3 A and 3B) of the dilator. For example, the dilator 354 can omit the handle portion 362 and / or other be otherwise configured to allow the delivery tool 352, or at least the sheath 358 thereof, to be moved (e.g., proximally and / or distally) over the shaft 364 of the dilator 354.

[0085] At block 404, the method 400 can include delivering, via one or more electrodes of the introducer system, one or more modulation signals to determine a position and / or an orientation of the introducer system relative to the target tissue. In some embodiments, the introducer system includes a delivery tool (such as, e.g., the delivery tool 352 of FIGS. 3A and 3B) and / or a dilator (such as, e.g., the dilator 354 of FIGS. 3 A and 3B) and delivering the one or more modulation signals can include delivering the one or more modulation signals via one or more first electrodes carried by the delivery tool (such as, e.g., the sheath electrodes 368 of FIGS. 3A and 3B) and / or one or more second electrodes carried by the dilator (such as, e.g., the electrically-activatable tip 372 of FIGS. 3A and 3B). The modulation signals delivered in block 404 can include navigation modulation signals configured to facilitate identification of the target tissue and / or tonic modulation signals configured to replicate (or at least be generally similar to) the modulation signals that would be delivered by an implantable device. For example, FIG. 5 A shows the electrically-activatable tip 372 delivering one or more first modulation signals SI and FIG. 5B shows the sheath electrodes 368 delivering one or more second modulation signals S2. The user can, based at least in part on the patient’s response to first and / or second modulation signals SI, S2, determine the position and / or an orientation of the introducer system 350 relative to the target tissue TT, e.g., with the goal of navigating the sheath electrodes 368 to a position that is at least proximate to the target tissue TT. For example, the user can observe the patient’s response to the one or more first modulations signals SI delivered by the electrically-activatable tip 372 to determine whether the electrically-activatable tip 372 is at least proximate to the target tissue TT. Once the user has made this determination, the user can repositioned (e.g., advance) the introducer system 350 to position the sheath electrodes 368 at least proximate to the target tissue TT, such as shown in FIG. 5B. The user can observe the patient’s response to the one or more second modulation signals S2 to determine or confirm that the sheath electrodes 368 are positioned at least proximate to the target tissue TT.-29- 184268789.1Attomey Docket No.: 132368.8037.WO00

[0086] Representative signal delivery parameters for the first and / or second modulation signals SI, S2 include (i) one or more frequencies in a frequency range of from about 1 Hz to about 50 Hz, such as from about 1 Hz to about 3 Hz, from about 1 Hz to about 2 Hz, and / or combinations thereof; (ii) one or more amplitudes in an amplitude range of from about 0.5 to 5 mA, such as from about 0.5 mA to about 2. 5 mA; (iii) one or more pulse widths in a pulse width range of from about 25 ps to about 1 ms, such as about 0.1 ms, about 0.2 ms, from about 0.1 ms to about 1 ms; and / or one or more other signal delivery parameters. In at least some embodiments, for example, the electrically-activatable tip 372 delivers a 3 Hz monopolar modulation signal that includes one or more shorter pulses (e.g., a first pulse width of about 0.1 ms) followed by one or more longer pulse (e.g., a pulse width of from about 0.15 ms to about 1 ms pulse width, such as about 0.2 ms) at an amplitude of from about 0.5 mA to about 2.5 mA or up to about 5 mA. In other embodiments, the one or more first modulation signals SI can include one or more repeating segments of one or more shorter pulses followed by one or more longer pulses, or a series of longer pulses with one or more shorter pulses between individual ones of the longer pulses. In some embodiments, the signal delivery parameters can include a low frequency pattern of oscillating low and high energy pulses that allows a user to gauge relative distance from the nerve by the rate of twitching response (a slow twitch, such as 1 Hz, indicates that only the higher energy pulses are producing capture, a faster twitch, such as about 3 Hz, indicates that lower energy pulses are also capturing and therefore the device is closer). By lowering the overall amplitude of the system (impacting high and low energy pulses identically), this process can be repeated to identified the desired or optimal position relative to a target tissue.

[0087] Often, conventional introducers use oscillating high / low energy modulation to navigate a needle tip to a position and then advance some distance blindly past that position. However, instead of navigating blindly, the sheath electrodes 368 of the introducer system 350 can be used to provide therapeutic or tonic modulation signals during at least this portion of the procedure. In some embodiments, the tonic modulation signals can have a frequency of from about 1 Hz to about 100 Hz or from about 10 Hz to about 100 Hz, such as about 30 Hz, an amplitude of from about 0.1 mA to about 10 mA or from about 0.25 mA to about 10 mA, such as about 2.5 mA, and / or a pulse width of from about 30 ps to about 500 ps or from about 50 ps to about 500 ps, such as about 100 ps. In some embodiments, one or more of the signal delivery parameters (e.g., frequency, amplitude, pulse width, etc.) of the tonic modulation signals are up to or at least 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, or 10 times greater than a-30- 184268789.1Attomey Docket No.: 132368.8037.WO00corresponding signal delivery parameter of the navigation modulation signals. The introducer system 350 can be advanced toward a target tissue while a user observes and / or measures the patient’s response to one or more first or navigation modulation signals SI delivered via the electrically-activatable tip 372 and / or one or more of the sheath electrodes 368. Once the user believes that the electrically-activatable tip 372 and / or one or more of the sheath electrodes 368 are positioned at least proximate to the target tissue TT, the user can cause the electrically-activatable tip 372 and / or one or more of the sheath electrodes 368 to deliver one or more second modulation signals S2. The second modulation signals S2 can include tonic modulation signals, high / low pulse modulation signals, and / or other modulation signals described herein, and / or combinations thereof. The user can characterize the patient’s response (e.g. breathing, endoscopy, etc.) to the first and / or second modulation signals SI, S2, e.g., to test the patient’s response to modulation from various different locations and / or at various different signal delivery parameters (e.g., navigation and / or tonic signal delivery parameters). If the response is satisfactory and / or otherwise expect to at least partially address the patient’s breathing obstruction, the user can place a signal delivery device at the identified location and / or cause the signal delivery device to provide modulation (e.g., tonic modulation) using one or more of the identified signal delivery parameters.

[0088] Corrections to the insertion trajectory can be made while moving the introducer system. Different ones or combinations of the sheath electrodes 368 may also be checked during navigation and / or before placement. In some embodiment, block 404 can include adjusting one or more of the parameters for delivering the modulation signal (e.g., amplitude, frequency, pulse width, duty cycle, etc.) until, e.g., the patient responds to the modulation signal and / or the patient’s response is satisfactory. This can include, for example, identify the optimal (e.g., lowest) amplitude and / or the optimal pulse width that produces a satisfactory, or even optimal, patient response. These data can then be used to select one or more parameters of the modulation signal delivered via the signal delivery device after, e.g., the signal delivery device has been implanted.

[0089] At block 406, the method 400 can include repositioning and / or reorienting the introducer system relative to the target tissue based at least in part on a response of the patient to the one or more modulation signals (block 404). If the patient’s response to the one or more first and second modulation signals SI, S2 is less than satisfactory (e.g., if the first and / or second modulation signals SI, S2 cause further collapse / obstruction of the patient’s airway), and / or if the patient is not responding to the one or more first and second modulation signals -31- 184268789.1Attomey Docket No.: 132368.8037.WO00SI, S2, the user can reposition (e.g., move proximally or distally, yaw, pitch, etc.) and / or reorient (e.g., rotate) the introduced system relative to the target tissue. For example, if the patient’s tongue and / or other airway tissues indicate signs of capture (e.g., twitching) in response to a 3 Hz electrical but only at amplitudes greater than 2 mA, the user can reposition and / or reorient the introducer system 350 until a desired response to a 3 Hz electrical signal with an amplitude of 2 mA or less is achieved.

[0090] During the repositioning and / or reorienting, the introducer system 350 can continue to deliver the one or more first and second modulation signals SI, S2 so that the user can receive instantaneous (or near instantaneous) feedback regarding how the patient responds to the one or more first and second modulation signals SI, S2 delivered while repositioning and / or reorienting the introducer system 350. The user can stop repositioning and / or reorienting the introducer system 350 when the patient’s response is satisfactory. A satisfactory response can be determined on a per-patient basis based at least in part on the target tissue and / or the severity of the patient’s breathing obstruction. In some embodiments, a satisfactory response can include observing a movement (e.g., anterior and / or caudal movement) of a base of the patient’s tongue. Block 406 is optional and can be omitted in at least some embodiments.

[0091] At block 408, the method 400 can include removing a dilator of the introducer system from a delivery device of the introducer system. For example, FIG. 5C shows the introducer system 350 with the dilator 354 (FIG. 5 A) being removed from within the delivery tool 352. To remove the dilator 354, the user can withdraw the dilator 354 proximally relative to the delivery tool 352 so that, e.g., the dilator 354 is removed from within the patient and moves proximally outwardly through the sheath 358. In some embodiments, the dilator 354 is coupled to the sheath 358 via the coupling features 376, 338 (FIG. 3B) during insertion and, accordingly, before removing the dilator 354 the user can uncouple the coupling features 376, 338 to decouple the dilator 354 from the sheath 358. To uncouple the coupling features 376, 338, the user can rotate the dilator 354 and / or the sheath 358 relative to each other, as described previously with reference to FIG. 3B.

[0092] At block 410, the method 400 can include positioning an implantable signal delivery device within the delivery device. For example, FIG. 5D shows the electrode array 384 of the signal delivery device 302 positioned within the sheath 358. The sheath 358 and other portions of the delivery tool 352 are shown as transparent in FIG. 5D to illustrate aspects of the present technology. The signal delivery device 302 can be inserted proximally through the delivery tool 352, e.g., until individual ones of the array electrodes 386 are aligned with the -32- 184268789.1Attomey Docket No.: 132368.8037.WO00corresponding ones of the sheath electrodes 368 as described previously herein. Because the sheath electrodes 368 have been positioned at least proximate to the target tissue TT, aligning the electrode array 386 with the sheath electrodes 368 is expected to position the electrode array 386 at least proximate to the target tissue TT. The first fixation feature 330a can be positioned distally beyond the sheath 358, e.g., in the deployed configuration to engage patient tissue, as described previously herein.

[0093] In some embodiments, one or more stop gauges 590 (individually identified as first or distal stop gauge 590a and second or proximal stop gauge 590b) can be coupled to the signal delivery device 302. The first stop gauge 590a can be coupled to the signal delivery device 302 at a first distance from the electrode array 386 and / or the first fixation feature 330a. The first distance can be selected such that, when the first stop gauge 590a contacts the delivery tool 352, the electrode array 386 is aligned with the sheath electrodes 368 and / or the first fixation features 330a is positioned distally beyond the distal terminus 359 of the sheath 358. The second stop gauge 590b can be positioned proximally from the first stop gauge 590b. the some embodiments, one or more of the stop gauges 590 include one or more marks or other indicia on the signal delivery device 302 that can be aligned with a corresponding portion of the delivery tool 352, in addition to or instead of components configured to be coupled to the signal delivery devices 302 and placed in contact with the delivery tool 352.[0094J At block 412, the method 400 can include confirming that the electrode array of the implantable signal delivery device is positioned at least proximate to the target tissue. Confirming that the electrode array is positioned at least proximate to the target tissue can include withdrawing the delivery tool over the signal delivery device to at least partially uncover the electrode array, delivering one or more modulation signals via the electrode array, and observing and / or measuring the patient’s response to the one or more modulation signals. For example, FIG. 5E shows the sheath 358 after it has been withdrawn over the signal delivery device 302 to at least partially uncover the electrode array 384. In some embodiments, the first stop gauge 590a (FIG. 5D) can be removed to allow the sheath 358 to be withdrawn over the signal delivery device 302. For example, after the first stop gauge 590a (FIG. 5D) has been removed the user can withdraw the delivery tool 352 proximally, e.g., into contact with the second stop gauge 590b. The second stop gauge 590b can be positioned a second distance from the electrode array 384. The second distance can be greater than a length of the delivery tool 352 and, accordingly, the electrode array 384 is positioned distally beyond the sheath 358 when the delivery tool 352 is in contact with the second stop gauge 590b. The second fixation feature -33- 184268789.1Attomey Docket No.: 132368.8037.WO00320b (FIG. 3C) can be still contained within the sheath 358 to make it easier to recapture and / or reposition the electrode array 384, if needed.

[0095] Once uncovered, the electrode array 384 can deliver one or more third modulation signals S3 to the patient and observe the patient’s response to the one or more third modulation signals S3. The one or more third modulation signals S3 can include one or more signal delivery parameters that are generally similar or identical to one or more of the first and / or second modulation signals SI, S2. For example, if while observing and / or measuring the patient’s response to one or more of the first and / or second modulation signals SI, S2 the user identifies certain signal delivery parameters (e.g., one or more frequencies, amplitudes, pulse widths, and / or the like) as producing a desired response in the patient, the user test all or a subset of those signal delivery parameters using the electrode array 384 to confirm that they produce a same or at least substantially similar patient response. If the patient’s response to the one or more third modulation signals S3 is not satisfactory, the method 400 can include (i) adjusting one or more of the parameters for delivering the modulation signal (e.g., amplitude, frequency, pulse width, duty cycle, etc.) and / or (ii) repositioning and / or reorienting the signal delivery device until, e.g., the modulation signals delivered to the patient produce a satisfactory response. Whether or not a given patient response is satisfactory can be determined on a per-patient basis based at least in part on the target tissue and / or the severity of the patient’s breathing obstruction. In some embodiments, a satisfactory response can improve the patient’s airflow by at least 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, or 100%. Additionally, or alternatively, a satisfactory response can include a motor response that reduces or entirely reverses the tissue collapse experienced by the patient.

[0096] At block 414, the method can include removing the delivery tool from the patient. For example, FIG. 5F shows the delivery tool 352 being withdrawn proximally over the signal delivery device 302 and out through the opening 588. As the delivery tool 352 is withdrawn, the second fixation feature 330b can be deploy to engage patient tissue and can, together with the first fixation feature 330a, secure the electrode array 384 in position at least proximate to the target tissue TT. Positioning the electrode array 384 at least proximate to the target tissue TT can include positioning the electrode array 384 a distance of from about 10mm to about 0.01mm from the target tissue, such as within up to 9mm, 8mm, 7mm, 6mm, 5mm, 4mm, 3mm, 2mm, 1mm, or 0.1mm from target tissue, within any distance therebetween, or within another suitable distance from the target tissue. In some embodiments, positioning the implantable-34- 184268789.1Attomey Docket No.: 132368.8037.WO00electrode array 384 at least proximate to the target tissue includes positioning the electrode array 384 in contact with and / or at least partially within the target tissue.

[0097] FIG. 6 is a flow diagram of a method 600 of preparing a signal delivery device for implantation in accordance with embodiments of the present technology. The method 600 can be performed with and / or by any of the systems and / or devices described herein, such as the introducer system 350 of FIGS. 3A and 3B and the signal delivery device 302 of FIG. 3C. In some embodiments, at least a subset of the method 600 can be performed by a physician, a practitioner, and / or other user. FIGS. 7A-7C are side views of the signal delivery device 302 and the delivery tool 352 during different stages of the method 600, in accordance with embodiments of the present technology. Individual ones of FIGS. 7A-7C are described below with reference to one or more blocks 602-610 of the method 600.

[0098] At block 602, the method 600 can include moving a signal delivery device through a sheath of a delivery device such that the signal delivery device is in a first position relative to the sheath. In some embodiments the signal delivery device includes proximal and distal fixation features and, in the first position, the proximal fixation feature is within the sheath and the distal fixation feature is positioned external to (e.g., distally beyond) the sheath. For example, FIG. 7 A illustrates the signal delivery device 302 positioned within the sheath 358 of the delivery tool 352. In FIG. 7A the signal delivery device 302 has been advanced through the sheath 358 into a first position, e.g., in which the distal fixation feature 330a is positioned distally beyond the distal terminus 359 of the sheath 358.

[0099] At block 604, the method 600 can include recording the first position. Recording the first position can include, for example, marking the signal delivery device while the signal delivery device is in the first position; a clinician or other user can reference this mark later (e.g., when implanting the signal delivery device) to again position the signal delivery device in the first position. For example, FIG. 7A illustrates a first mark Ml on the signal delivery device 302 immediately adjacent to a proximal-most end of the handle portion 356. A user can make the first mark Ml on the signal delivery device 302 using a sterile pen and / or one or more other suitable marking implements (e.g., tape, stop gauges, string, and / or combinations thereof). In some embodiments the first mark Ml is pre-formed on the signal delivery device 302, e.g., such that block 602 and / or block 604 can be omitted. When a clinician or other user is advancing the signal delivery device 302 through the delivery tool 352, e.g., during a later implantation procedure, the user can align the first mark Ml with the handle portion 356 to accurately place the signal delivery device 302 in the first position relative to the delivery tool -35- 184268789.1Attomey Docket No.: 132368.8037.WO00352. The first mark Ml can be a first distance DI from the proximal end of the distal fixation feature 330a. Accordingly, in some embodiments recording the first position can include forming the first mark Ml on the signal delivery device 302 at the first distance DI from the distal fixation feature 330a, e.g., with or without the signal delivery device 302 being positioned within the delivery tool 352 (e.g., block 602). For example, instead of moving the signal delivery device 302 through the sheath 358 (e.g., block 602) a user can instead position the signal delivery device 302 external and adjacent to the sheath 358, place the distal fixation feature 330a in the same longitudinal position relative to the distal terminus 359 as shown in FIG. 7A, and then record the first mark Ml .[001001 At block 606, the method 600 can include moving the signal delivery device through the sheath into a second position relative to the sheath. In the second position both the proximal and distal fixation features can be can be positioned external to (e.g., distally beyond) the sheath. For example, FIG. 7B illustrates the signal delivery device 302 in the second position, e.g., in which the distal and proximal fixation features 330a, b are both positioned distally beyond the distal terminus 359 of the sheath 358. The proximal fixation feature 330b can be a predetermined distance D3 (e.g., up to 0.1 cm, 0.2 cm, 0.3 cm, 0.4 cm, 0.5 cm, 1 cm, combinations thereof, and / or any distance therebetween) beyond the distal terminus 359 of the sheath 358. The predetermined distance D3 can be selected to provide sufficient distance for the proximal fixation feature 330b to expand / transition into the expanded / deployed configuration.

[0101] At block 608, the method 600 can include recording the second position. Block 608 can be at least generally similar to block 604. For example, FIG. 7B illustrates a second mark M2 on the signal delivery device 302 immediately adjacent to a proximal-most end of the handle portion 356. A user can make the second mark M2 on the signal delivery device 302 using a sterile pen and / or one or more other suitable marking implements (e.g., tape, stop gauges, string, and / or combinations thereof). In some embodiments the second mark M2 is preformed on the signal delivery device 302, e.g., such that block 606 and / or block 608 can be omitted. When a clinician or other user is advancing the signal delivery device 302 through the delivery tool 352, e.g., during a later implantation procedure, the user can align the second mark M2 with the handle portion 356 to accurately place the signal delivery device 302 in the second position relative to the delivery tool 352. The second mark M2 can be a second distance D2 from the proximal end of the proximal fixation feature 330b. Accordingly, in some embodiments recording the second position can include forming the second mark M2 on the -36- 184268789.1Attomey Docket No.: 132368.8037.WO00signal delivery device 302 at the second distance D2 from the proximal fixation feature 330b, e.g., with or without the signal delivery device 302 being positioned within the delivery tool 352 (e.g., block 602 and / or block 606). For example, instead of moving the signal delivery device 302 through the sheath 358 (e.g., block 602 and / or block 606) a user can instead position the signal delivery device 302 external but adjacent to the sheath 358, place the proximal fixation feature 330b in the same longitudinal position relative to the distal terminus 359 as shown in FIG. 7B, and then record the second mark M2.

[0102] At block 610, the method 600 can include removing the signal delivery device from the delivery tool, e.g., for later reinsertion during an implantation procedure. For example, FIG. 7C illustrates the signal delivery device 302 after is has been removed from the delivery tool 352 (FIGS. 7A and 7B). The first and second marks Ml, M2 can be retained on the signal delivery device 302, e.g., for later reference by a clinician or other user. The marks Ml, M2 are expected to remain the same respective distances DI, D2 from the fixation features 330a, b at which they were formed. In some embodiments, the method 600 further comprises coupling one or more stop gauges to the signal delivery device at or at least proximate to individual ones of the marks. For example, a user can connect the first stop gauge 590a (FIG. 5D) to the signal delivery device 302 at or at least proximate to the first mark Ml and can connect the second stop gauge 590b (FIG. 5D) to the signal delivery device 302 at or at least proximate to the second mark M2. The user can use / ob serve the stop gauges 590a,b to facilitate moving the signal delivery device 302 through the delivery tool 352, e.g., as described elsewhere herein, including with reference to at least one or more of FIGS. 5D-5F.

[0103] FIG. 8 is a flow diagram of a method 800 for recapturing a signal delivery device in accordance with embodiments of the present technology. The method 800 can be performed with and / or by any embodiment of the systems and / or devices described herein, such as the introducer system 350 of FIGS. 3 A and 3B, one or more of the components thereof (e.g., the delivery tool 352 and / or the dilator 354), one or more of the signal delivery devices described herein (e.g., one or more of the signal delivery devices 102, 202, 302) and / or the LRT 340 of FIG. 3D. In some embodiments, at least a subset of the method 800 can be performed by a physician, a practitioner, and / or other user. FIGS. 9A-9D are side views of the signal delivery device 302 during different stages of the method 800, in accordance with embodiments of the present technology. Individual ones of FIGS. 9A-9D are described below with reference to one or more blocks 802-810 of the method 800.-37- 184268789.1Attomey Docket No.: 132368.8037.WO00

[0104] In block 802, the method 800 can include determining that a signal delivery device is not positioned at least proximate to a target tissue of a patient. At least some aspects of block 802 can be at least generally similar or identical to block 404 and / or block 406 of the method 400. For example, the signal delivery device can be at least generally similar in structure and / or function to one or more of the signal delivery devices described herein (e.g., one or more of the signal delivery devices 102, 202, 302) and, for example, can be configured to deliver one or more electrical signals to the patient. Accordingly, determining that the signal delivery device is not positioned at least proximate to the target tissue can include delivering, via the signal delivery device, one or more electricals to the patient, observing the patient’s response to the delivered electrical signal(s), and determining that the observed response is other or different than an expected patient response. For example, FIG. 9 A illustrates the delivery tool 352 and the signal delivery device 302 positioned at least partially within the patient P and with the array electrodes 386 of the signal delivery device 302 positioned distally beyond the distal terminus 359 of the sheath 358. The array electrodes 386 can deliver one or more electrical signals (e.g., the one or more third modulation signals S3 described previously with reference to at least FIG. 5E) and the user can observe the patient’s response to these one or more electrical signals to determine whether the array electrodes 386 are positioned at least proximate to target tissue TT. In FIG. 9A, the target tissue TT is distal to the array electrodes 386 and the electrical signal(s) S3 do not reach the target tissue TT. Accordingly, the patient’s response to the electrical signal(s) S3 is expected to be other or different than an expected patient response and the user can determine that the array electrodes 386 are not positioned at least proximate to the target tissue TT.[00105| In block 804, the method 800 can include moving a lead recapture tool over the signal delivery device to position one or more capture features in contact with one or more fixation features of the signal delivery device. Moving the lead recapture tool over the signal delivery device can include advancing the lead recapture tool distally over the signal delivery device, e.g., until the one or more capture features are in contact with the one or more fixation features. In some embodiments, moving the lead recapture tool over the signal delivery device includes applying tension to and / or straightening the signal delivery device and / or rotating the lead recapture tool relative to the signal delivery device. For example, FIG. 9B illustrates the LRT 340 as it is moved over the signal delivery device 302 toward the fixation features 330a, b. As described elsewhere herein, including with reference to at least FIG. 3D, the signal delivery device 302 can pass through the lumen 346 of the LRT 340, e.g., to allow a user to advance the-38- 184268789.1Attomey Docket No.: 132368.8037.WO00LRT 340 distally over the signal delivery device 302. The sheath 358 can be configured to receive the LRT 340, e.g., in a space between the signal delivery device 302 and an inner wall of the sheath 358. The user can rotate the LRT 340 (e.g., clockwise or counter clockwise) while advancing the LRT 340 over the signal delivery device 302.[00106! In block 806, the method 800 can include actuating the lead recapture tool to cause all or a subset of the one or more fixation features to transition from a deployed configuration toward and / or to a delivery configuration. In some embodiments, actuating the lead recapture tool includes rotating the lead recapture tool relative to the signal delivery device while the one or more capture features are in contact with one or more of the signal delivery device’s fixation features. As the lead recapture tool rotates, the capture feature(s) can fold, collapse, and / or otherwise cause the fixation feature(s) of the signal delivery device to transition from the deployed configuration toward and / or to the delivery configuration. For example, FIG. 9C illustrated the LRT 340 being rotated relative to the signal delivery device 302. The capture features 348 of the LRT 340 are engaged with the proximal fixation features 330b and can cause the proximal fixation feature 330b to bend or fold inwardly as the LRT 340 is rotated. With enough rotation the LRT 340 can be advanced over the proximal fixation feature 330b to capture or re-capture the proximal fixation feature 330b and hold or maintain it in the collapsed or delivery configuration, and the LRT 340 can be advanced so place the capture features 348 in contact with the distal fixation feature 330a and actuated (e.g., again) to capture or re-capture the distal fixation feature 330a and hold or maintain it in the collapsed or delivery configuration.|00107| In block 808, the method 800 can include repositioning the signal delivery device relative to the patient. Repositioning the signal delivery device can include moving the signal delivery device proximally and / or distally and / or otherwise changing a position and / or an orientation of the signal delivery device relative to the patient. In at least some embodiments, repositioning the signal delivery device includes removing the signal delivery device from the patient. For example, FIG. 9D illustrated the LRT 340 and the signal delivery device 302 being removed from the patient P. A user can remove the LRT 340 and the signal delivery device 302 by withdrawing them proximally from the delivery tool 352. The delivery tool 352 can remain in place (e.g., positioned at least partially within the patient P) or can be removed from the patient P. In these and / or other embodiments, repositioning the signal delivery device 302 includes positioning the signal delivery device 302 at least proximate to the target tissue. For example, the user can remove the signal delivery device 302 and the LRT 340 from the delivery -39- 184268789.1Attomey Docket No.: 132368.8037.WO00tool 352, insert or reinsert the dilator 354 into the delivery tool 352, and use the dilator 354 and / or the delivery tool 352 to identify the target tissue, e.g., as described elsewhere herein including with reference to one or more of FIGS. 3A-3C and 4-5F.

[0108] FIG. 10 is a flow diagram of a method 1000 for implanting one or more signal delivery devices in a patient to at least partially address the patient’s sleep apnea, in accordance with embodiments of the present technology. The method 1000 can be performed with and / or by any embodiment of the systems and / or devices described herein, such as the introducer system 350 of FIGS. 3A and 3B, one or more of the components thereof (e.g., the delivery tool 352 and / or the dilator 354), and / or one or more of the signal delivery devices 302 of FIG. 3C. In some embodiments, at least a subset of the method 1000 can be performed by a physician, a practitioner, and / or other user. FIGS. 11 A-l IN are side views of the introducer system 350 and / or one or more signal delivery devices during different stages of the method 1000, in accordance with embodiments of the present technology. Individual ones of FIGS. 11 A-l IN are described below with reference to one or more blocks 1002-1024 of the method 1000.

[0109] In block 1002, the method 1000 includes identifying a first target implant location at least proximate to one or more anterior branches of a patient’s hypoglossal nerve. Identifying the first target implant location can include identifying the first target implant location using one or more imaging and / or other visualization techniques (e.g., ultrasound) and / or one or more modulation-response techniques. In at least some embodiments, for example, a user can use an ultrasound probe to visually identify the first target implant location, select an insertion point for an introducer system, and / or observe at least a portion of the introducer system as it is advanced into the patient and / or toward the first target implant location. The introducer system can be configured to deliver one or more electrical signals to the patient and, accordingly, in at least some embodiments the user can monitor the patient’s response to the delivered electrical signal(s) to determine whether the introducer system is at or near the first target implant location and / or otherwise at least proximate to one or more anterior branches of a patient’s hypoglossal nerve. The anterior branches of the hypoglossal nerve may be difficult to visualize using ultrasound (and / or other visualization techniques), so while the user may be able to guide the introducer system into the generally vicinity of the first target implant location using ultrasound the user may need to rely on (e.g., solely rely on) the patient’s response to the delivered electrical signal(s) to confirm that the introducer system is at the first target implant location and / or otherwise at least proximate to the anterior branches. At least some aspects of-40- 184268789.1Attomey Docket No.: 132368.8037.WO00block 1002 can be at least generally similar or identical to one or more of blocks 402-406 of the method 400 and / or FIGS. 5A and 5B.

[0110] FIG. 11 A, for example, shows the introducer system 350 with a distal portion thereof positioned through a first opening 1188a formed in an underside of the patient’s jaw. The delivery tool 352 can extend through the first opening 1188a and the sheath electrodes 368 carried by the delivery tool 352 and / or the electrically-activatable tip 372 of the dilator 354 can deliver one or more electrical signals to the patient, e.g., to help the user identify the location of the sheath electrodes 368 relative to the anterior branches AB of the hypoglossal nerve and / or navigate the sheath electrodes 368 into first target implant location TIL1 and / or otherwise at least proximate to the one or more anterior branches AB. In some embodiments, the user can use an ultrasound probe 1099 and / or one or more other visualization devices to identify the first target implant location TIL1 and / or observe the introducer 350 while moving it toward and / or into the first target implant location TIL1. For example, the user can start with the probe 1099 straight up the chin, centered around the patient’s midsagittal line and / or at the halfway point between the patient’s mandible and the patient’s hyoid bone to obtain a coronal view of the tongue anatomy and / or locate the distal portion of the hypoglossal nerve that innervates the genioglossus on the implantation side, and can translate the probe 1099 anteriorly and / or superiorly as need, e.g., while keeping the probe 1099 perpendicular or substantially perpendicular to the patient’s skin surface (e.g., such that the probe 1099 is closer to the mandible than to the hyoid bone). Optionally, to confirm that the user has identified the hypoglossal nerve, the user can image the hypoglossal nerve against other, nearby anatomical structures by, e.g., tilting the probe 1099 around its pitch axis (both directions) to follow the trajectory of the HGN as a “curved line” entering the GG, translating the probe 1099 laterally toward the implantation side while keeping the probe 1099 perpendicular to the skin surface (e.g., such that the HGN lies in the center of the ultrasound image), and / or rotating the probe 1099 counterclockwise by at least 45 degrees around the “roll” axis to obtain a parasagittal view (e.g., so that the HGN appears like a “bubble” as it is imaged perpendicularly, i.e., cross-sectionally). The user may, additionally or alternatively, tilt the probe 1099 around its “yaw” axis while keeping the probe 1099 perpendicular or substantially perpendicular to the skin surface, e.g., such that the probe 1099 points laterally towards the implantation side and the hypoglossal nerve remains in the center of the ultrasound image, and / or use a color Doppler mode of the probe 1099 to confirm the identification of the hypoglossal nerve against one or more nearby blood vessels. Once the user has identified the hypoglossal nerve, the user can-41- 184268789.1Attomey Docket No.: 132368.8037.WO00identify a first target implant location at least proximate to one or more of the anterior branches AB of the hypoglossal nerve and / or plan an insertion trajectory to reach the first target implant location. The insertion trajectory can be, for example, a straight line from the skin surface to a location at least proximate to one or more of the anterior branches AB. The angle between the insertion trajectory and the patient’s sagittal plane can be less than 60 degrees. Additional details regarding insertion trajectories for placing a signal delivery device at least proximate to one or more of the anterior branches AB can be found in U.S. Pat. App. No. 18 / 393,537, which is incorporated by reference herein. The user can make a mark on the patient’s skin to identify an entry point for the introducer system 350 and then form the opening 1188a at or near this mark. The user can advance the introducer system 350 further through the opening 1188a, e.g., until the electrical signal(s) delivered by the sheath electrodes 368 and / or the electrically-activatable tip 372 produce a desired or expected motor response in the patient.

[0111] In block 1004, the method 1000 includes implanting at least a first signal delivery device at the first target implant location and / or at least proximate to one or more of the anterior branches of the patient’s hypoglossal nerve. FIG. 11B, for example, shows the signal delivery device 302 positioned through the opening 1188a and with the array electrodes 386 positioned at the first target implant location TIL1 and / or otherwise at least proximate to one or more of the anterior branches AB. A proximal portion of the signal delivery device 302 can be external to the patient, e.g., for later connection to an IPG.

[0112] Implanting at least the first signal delivery device can include using the introducer system to implant at least the first signal delivery device. For example, the introducer system can include a dilator positioned at least partially within a delivery tool and, after the user has identified the first target implant location (block 1002), the user can remove the dilator from the delivery tool and move at least the first signal delivery device through the delivery tool and into the first target implant location and / or otherwise at least proximate to one or more of the anterior branches. In some embodiments, implanting at least the first signal delivery device includes uncovering, and delivering one or more electrical signals via, the first signal delivery device and observing and / or measuring the patient’s response to the delivered electrical signal(s) to confirm that the first signal delivery device is at the first target implant location and / or otherwise positioned at least proximate to one or more of the anterior branches. For example, at least some aspects of block 1004 can be at least generally similar or identical to block 408 and / or block 410 of the method 400, one or more of FIGS. 5C-5F, one or more of blocks 802-808 of the method 800, and / or one or more of FIGS. 9A-9D.-42- 184268789.1Attomey Docket No.: 132368.8037.WO00

[0113] In block 1006, the method 1000 can includes identifying a second target implant location at least proximate to the patient’s ansa cervicalis nerve. The second target implant location can include a location at least proximate to one or more branches of the ansa cervicalis that innervate the sternohyoid and sternothyroid muscles, at least proximate to the main loop of the ansa cervicalis, and / or any or portion or portions of the ansa cervicalis described herein and / or in U.S. Pat. No. 12,246,175, which is incorporated by reference herein. Identifying the second target implant location can include identifying the second target implant location using one or more imaging and / or other visualization techniques (e.g., ultrasound) and / or one or more modulation-response techniques. In at least some embodiments, for example, a user can use an ultrasound probe to visually identify the second target implant location, select an insertion point for an introducer system, and / or observe at least a portion of the introducer system as it is advanced into the patient and / or toward the first target implant location. The introducer system can be configured to deliver one or more electrical signals to the patient and, accordingly, in at least some embodiments the user can observe and / or measure the patient’s response to the delivered electrical signal(s) to determine whether the introducer system is at or near the second target implant location and / or otherwise at least proximate to the patient’ s ansa cervicalis nerve. At least some portions of the ansa cervicalis nerve may be difficult to visualize using ultrasound (and / or other visualization techniques) — for example, at least a portion of the branch that innervates the sternohyoid and sternothyroid muscles may be located between these muscles, making it difficult to visualize — so while the user may be able to guide the introducer system into the generally vicinity of the second target implant location using ultrasound the user may need to rely on (e.g., solely rely on) the patient’s response to the delivered electrical signal(s) to confirm that the introducer system is at the second target implant location and / or otherwise at least proximate to the ansa cervicalis nerve. At least some aspects of block 1006 can be at least generally similar or identical to one or more of blocks 402-406 of the method 400 and / or FIGS. 5A and 5B.

[0114] FIG. 11C, for example, shows the introducer system 350 with a distal portion thereof positioned through a second opening 1188b formed in an anterolateral portion of the patient’s neck. The introducer system 350 can be the same introducer system used to place the signal delivery device (e.g., FIGS. 11A and 11B) or a different introducer system having a same or at least generally similar configuration. The delivery tool 352 can extend through the second opening 1188b and the sheath electrodes 368 carried by the delivery tool 352 and / or the electrically-activatable tip 372 of the dilator 354 can deliver one or more electrical signals-43- 184268789.1Attomey Docket No.: 132368.8037.WO00to the patient, e.g., to help the user identify the location of the sheath electrodes 368 relative to the ansa cervicalis nerve and / or navigate the sheath electrodes 368 into second target implant location TIL2 and / or otherwise at least proximate to the ansa cervicalis. As best seen in detailed view 11C.1, the second target implant location TIL2 can be at least proximate to a branch (e.g., the third branch B3) of the ansa cervicalis nerve AC that runs between and / or innervates the sternohyoid muscle SH and the sternothyroid muscle ST of the patient P.|00115] In some embodiments, the user can use an ultrasound probe 1099 and / or one or more other visualization devices to identify the second target implant location TIL2 and / or observe the introducer 350 while moving it toward and / or into the second target implant location TIL2. For example, the user can start with the probe 1099 superior and / or parallel to the patient’s clavicle, e.g., such that a side edge of the probe 1099 is at or near the midline of the patient’s neck. The user can translate the probe 1099 superiorly from the start position until the omohyoid muscle is seen crossing medially over the common carotid artery, e.g., to assist with identifying the sternohyoid and / or sternothyroid muscles. The user can continue moving the probe 1099 to following the omohyoid muscle, e.g., by translating the probe 1099 inferiorly until the omohyoid muscle has crossed laterally over the common carotid artery; the sternohyoid and / or sternothyroid muscles should now be visible in-line or medial to the common carotid artery, and a medial branch of the ansa cervicalis nerve may be observed as a thickening between the border between the sternohyoid and sternothyroid muscles. Optionally, the user can rotate the probe 1099 while keeping the sternohyoid and / or sternothyroid muscles in the ultrasound view, e.g., to assist in identifying a needle trajectory that avoids the patient’s sternocleidomastoid muscle. The user can also use a color Doppler mode to identify vasculature in the area, e.g., to assist in identifying a needle trajectory that avoids any such vasculature. Once the user has identified the ansa cervicalis nerve and / or the medial branch thereof, the user can identify a second target implant location at least proximate to the ansa cervicalis nerve and / or plan an insertion trajectory to reach the second target implant location. The insertion trajectory can be, for example, a straight line from the skin surface to a location at least proximate to the identified portion of ansa cervicalis nerve. The insertion trajectory can extend anteriorly and / or medially, e.g., from a lateral location on the patient’s neck. Additional details regarding insertion trajectories for the ansa cervicalis nerve can be found in U.S. Pat. No.12,246,175, the entirety of which is incorporated by reference herein. The user can make a mark on the patient’s skin to identify an entry point for the introducer system 350 and then form the opening 1188b at or near this mark. The user can advance the introducer system 350-44- 184268789.1Attomey Docket No.: 132368.8037.WO00further through the opening 1188a, e.g., until the electrical signal(s) delivered by the sheath electrodes 368 and / or the electrically-activatable tip 372 produce a desired or expected motor response in the patient.

[0116] In block 1008, the method 1000 can include implanting at least a second signal delivery device at the second target implant location and / or at least proximate to the patient’s ansa cervicalis nerve. Detail view 11C.2 in FIG. 11C and FIG. 1 ID, for example, show a signal delivery device 302’ positioned through the opening 1188b and with array electrodes 386’ positioned at the second target implant location TIL2 and / or otherwise at least proximate to the ansa cervicalis nerve AC (e.g., the third branch B3 of the ansa cervicalis nerve AC). As best seen in detail view 11C.2, all or at least a subset of the array electrodes 386’ can be located between the sternohyoid and sternothyroid muscles. FIG. 11D also illustrates the signal delivery device 302 and the array electrodes 386 in location described previously with reference to FIG. 11B, e.g., in the first target implant location TIL1 and / or otherwise at least proximate to one or more of the anterior branches AB of the patient’s hypoglossal nerve. The signal delivery device 302’ and the array electrodes 386’ can be at least generally similar or identical in structure and / or function to the delivery device 302 and the array electrodes 386. For embodiments in which the signal delivery device 302’ is configured to be coupled to a separate IPG, a proximal portion of the signal delivery device 302’ can be external to the patient, e.g., for later connection to the IPG.

[0117] Block 1008 can include using the introducer system to implant at least the second signal delivery device. For example, the introducer system can include a dilator positioned at least partially within a delivery tool and, after the user has identified the second target implant location (block 1006), the user can remove the dilator from the delivery tool and move at least the second signal delivery device through the delivery tool and into the second target implant location and / or otherwise at least proximate to the patient’s ansa cervicalis nerve. In some embodiments, implanting at least the second signal delivery device includes uncovering, and delivering one or more electrical signals via, the second signal delivery device and monitoring the patient’s response to the delivered electrical signal(s) to confirm that the second signal delivery device is at the second target implant location and / or otherwise positioned at least proximate to the patient’s ansa cervicalis nerve. For example, at least some aspects of block 1006 can be at least generally similar or identical to block 408 and / or block 410 of the method 400, one or more of FIGS. 5C-5F, one or more of blocks 802-808 of the method 800, and / or one or more of FIGS. 9A-9D.-45- 184268789.1Attomey Docket No.: 132368.8037.WO00

[0118] If the one or both of the signal delivery devices 302, 302’ are configured to be coupled to an IPG, the method can further include one or more of blocks 1010-1020. If not, such as when one or both of the signal delivery devices 302, 302’ are configured to receive power wirelessly as described elsewhere herein (e.g., including with reference to at least FIG. 2B), then one or more of blocks 1010-1020 may be omitted and / or the method 1000 may conclude after block 1008.

[0119] In block 1010, the method 1000 can include forming a first tunnel connecting the first target implant location to a third target implant location. The third target implant location can be spaced apart from the first target implant location and / or the second target implant location. In at least some embodiments, for example, the third target implant location includes a subcutaneous pocket formed inferior to the patient’s clavicle. Forming the first tunnel can include using a tunneling tool to form the first tunnel. The tunneling tool can include a sheath and a dilator that can be advanced together toward and / or into the third target implant location, after which point the dilator can be removed and the sheath can at least partially define the first tunnel. FIGS. HE and 1 IF, for example, illustrate a tunneling tool 1190 configured in accordance with embodiments of the present technology. Tunneling tool 1190 can include a sheath 1192 and a dilator 1194 configured to be received within the sheath 1192. The sheath 1192 and the dilator 1194 can be inserted into the first opening 1188a and advanced, e.g., inferiorly, toward third target location TIL3, e.g., a subcutaneous pocket formed inferior to the patient’s clavicle. When at least a distal portion of the sheath 1192 is at least proximate to the third target implant location TIL3, the user can remove the dilator 1194 from the sheath 1192 and the sheath 1192 can at least partially define the first tunnel. Because the sheath 1192 was inserted into the patient P through the first opening 1188a, the same opening used to place the signal delivery device 302 at the first target implant location TIL1, the first tunnel can connect the first target implant location TIL1 to the third target implant location TIL3.

[0120] In block 1012, the method 1000 can include feeding a proximal portion of the first signal delivery device through the first tunnel. Feeding the proximal portion of the first signal delivery device through the first tunnel can include feeding the proximal portion of the first signal delivery device through the sheath of the tunneling tool, e.g., until the proximal portion of the first signal delivery device is positioned at least partially within the third target implant location. FIGS. 11G and 11H, for example, illustrate a proximal portion of the signal delivery device 302 being fed through the first tunnel. A user can advance the proximal portion of the signal delivery device 302 through (e.g., inferiorly and / or distally through) the sheath 1192-46- 184268789.1Attomey Docket No.: 132368.8037.WO00until the proximal portion of the signal delivery device 302 is positioned at least partially within the third target implant location TIL3. In some embodiments, the user can continue feeding the proximal portion of the signal delivery device 302 through the sheath 1192 until no portion of the signal delivery device 302 extends outwardly through the first opening 1188a.[00121 j In block 1014, the method 1000 can include forming a second tunnel connecting the second target implant location to the third target implant location. Forming the second tunnel can include using a tunneling tool, e.g., the tunneling tool described in block 1010, to form the second tunnel. For example, the tunneling tool can include a sheath and a dilator that can be advanced together toward and / or into the third target implant location, after which point the dilator can be removed and the sheath can at least partially define the second tunnel. FIGS. Ill and 11 J, for example, illustrate the tunneling tool 1190 being used to form a second tunnel. The sheath 1192 and the dilator 1194 of the tunneling tool 1190 can be inserted into the second opening 1188b and advanced, e.g., inferiorly, toward the third target location TIL3. When at least a distal portion of the sheath 1192 is at least proximate to the third target implant location TIL3, the user can remove the dilator 1194 from the sheath 1192 and the sheath 1192 can at least partially define the second tunnel. Because the sheath 1192 was inserted into the patient P through the second opening 1188b, the same opening used to place the signal delivery device 302’ at the second target implant location TIL2, the second tunnel can connect the second target implant location TIL2 to the third target implant location TIL3.

[0122] In block 1016, the method 1000 can include feeding a proximal portion of the second signal delivery device through the second tunnel. Feeding the proximal portion of the second signal delivery device through the second tunnel can include feeding the proximal portion of the second signal delivery device through the sheath of the tunneling tool, e.g., until the proximal portion of the second signal delivery device is positioned at least partially within the third target implant location. FIGS. 1 IK and 1 IL, for example, illustrate a proximal portion of the signal delivery device 302’ being fed through the second tunnel. A user can advance the proximal portion of the signal delivery device 302’ through (e.g., inferiorly and / or distally through) the sheath 1192 until the proximal portion of the signal delivery device 302’ is positioned at least partially within the third target implant location TIL3. In some embodiments, the user can continue feeding the proximal portion of the signal delivery device 302’ through the sheath 1192 until no portion of the signal delivery device 302 extends outwardly through the second opening 1188b.-47- 184268789.1Attomey Docket No.: 132368.8037.WO00

[0123] In block 1018, the method 1000 can include connecting the first and / or second signal delivery devices to an implantable pulse generator (IPG). The IPG can be at least generally similar or identical in structure and / or function to the IPG 104 (FIG. 2A) and can configured to be operably coupled to the first signal delivery device and / or the second signal delivery device, e.g., so as to cause one or both of the first and / or second signal delivery devices to deliver one or more electrical signals to one or more of the anterior branches of the patient’s hypoglossal nerve and / or the patient’s ansa cervicalis nerve, respectively. FIG. 11M, for example, illustrates, the signal delivery devices 302, 302’ coupled to the IPG 104. The signal delivery devices 302, 302’ can be coupled to the IPG 104 while the IPG 104 is positioned external to the patient P. For example, the proximal portions of one or both of the signal delivery devices 302, 302’ can include an electrical connector configured to be received within and / or electrically coupled to a corresponding terminal in a header of the IPG 104.

[0124] In block 1020, the method 1000 can include positioning the IPG (block 1018) in the third target implant location. FIG. 1 IN, for example, illustrates the IPG 104 positioned in the third target implant location TIL3. Once so positioned, any incision or other opening created to provide access to the third target implant location TIL3 can be closed, e.g., with sutures and / or one or more other suitable closure techniques.5. Examples

[0125] The following examples provide further embodiments of the present technology:1. A system for addressing sleep apnea in a patient, the system comprising: a delivery tool including a handle, a sheath coupled to and extending distally from the handle, and one or more sheath electrodes coupled to a distal end portion of the sheath; anda signal delivery device including a body having a proximal end portion and a distal end portion opposite the proximal end portion, one or more array electrodes coupled to the distal end portion, and a fixation feature coupled to the body at a location between the one or more array electrodes and a distal end terminus of the body,wherein the signal delivery device is configured to be received at least partially within the sheath at a position in which individual ones of the one or more array electrodes are aligned with corresponding ones of the one or more sheath electrodes and the fixation feature is positioned distally beyond the sheath.-48- 184268789.1Attomey Docket No.: 132368.8037.WO002. The system of example 1 wherein, when the signal delivery device is received within the sheath, individual ones of the one or more array electrodes are positioned radially inwardly from the corresponding ones of the one or more sheath electrodes.3. The system of example 1 or example 2, further comprising a dilator configured to be received within the sheath with a distal tip of the dilator extending distally beyond the sheath, wherein, when the dilator is received within the sheath, the dilator and the sheath are configured to be advanced together toward a target tissue of a patient to create an insertion path for the signal delivery device.4. The system of example 3 wherein the distal tip of the dilator is electrically activatable, and wherein the system is configured to deliver one or more electrical signals between the dilator tip and the one or more sheath electrodes.5. The system of any of examples 1-4, further comprising an external pulse generator configured to be operably coupled to the one or more sheath electrodes, wherein the external pulse generator includes a processor and a non-transitory, computer-readable medium programmed with instructions that, when executed by the processor, causes the external pulse generator to deliver, via one or more of the sheath electrodes, an electrical signal comprising a plurality of first pulses and a plurality of second pulses between individual ones of the plurality of first pulses, wherein each of the plurality of first pulses have a first pulse width and where each of the plurality of second pulses have a second pulse width less than the first pulse width.6. The system of example 5 wherein the first pulse width is about 0.2 milliseconds and wherein the second pulse width is about 0.1 milliseconds.7. The system of example 5 or example 6 wherein the electrical signal has a frequency of from about 1 hertz to about 3 hertz.8. The system of any of examples 5-7 wherein the electrical signal has an amplitude of up to 5 mA.-49- 184268789.1Attomey Docket No.: 132368.8037.WO009. The system of any of examples 5-8, further comprising a dilator configured to be received within the sheath with an electrically-activatable distal tip of the dilator extending distally beyond the sheath, wherein, when the dilator is received within the sheath, the dilator and the sheath are configured to be advanced together toward a target tissue of a patient to create an insertion path for the signal delivery device, and wherein the instructions includes instructions that, when executed by the processor, cause the external pulse generator to deliver the electrical signal via the electrically-activatable distal tip of the dilator.10. The system of any of examples 1-9 wherein the fixation feature is a first fixation feature, wherein the signal delivery device further includes a second fixation feature positioned proximally from the one or more array electrodes, and wherein, when the signal delivery device is received within the sheath at the position, the second fixation feature is positioned within the sheath.11. The system of any of examples 1-10 wherein the fixation feature includes a fixation body coupled to the body of the signal delivery device and a plurality of fins coupled to the fixation body, and wherein, when the signal delivery device is received at least partially within the sheath at the position, the plurality of fins are configured to transition from a collapsed state toward and / or to an extended state to at least partially prevent the one or more array electrodes from moving relative to the patient.12. A method for addressing sleep apnea in a patient, the method comprising: percutaneously advancing a dilator and a sheath of an introducer system into a patient and toward a target tissue of the patient;delivering, via one or more sheath electrodes carried by the sheath, a first electrical signal to the patient to determine a position and / or orientation of the introducer system relative to the target tissue;determining, based at least partially on a response of the patient to the first electrical signal, that the one or more sheath electrodes are positioned at least proximate to the target tissue;removing the dilator from within the sheath;moving a signal delivery device distally through the sheath into a position in which one or more array electrodes carried by the signal delivery device are aligned with-50- 184268789.1Attomey Docket No.: 132368.8037.WO00corresponding ones of the one or more sheath electrodes and in which a fixation feature coupled to the signal delivery device and located distal to the one or more array electrodes is positioned distally beyond the sheath to engage one or more tissues of the patient;withdrawing the sheath proximally over the signal delivery device to uncover all or a subset of the one or more array electrodes;delivering, via one or more of the array electrodes, a second electrical signal to the patient;determining, based at least partially on a response of the patient to the second electrical signal, that the one or more array electrodes are positioned at least proximate to the target tissue; andremoving the sheath from within the patient.13. The method of example 12 wherein the fixation feature is a distal fixation feature, wherein the signal delivery device further includes a proximal fixation feature coupled to the signal delivery device and located proximal to the one or more array electrodes, and wherein withdrawing the sheath proximally over the signal delivery device to uncover all or a subset of the one or more array electrodes includes withdrawing the sheath proximally over the signal delivery device while keeping the proximal fixation feature positioned within the sheath.14. The method of example 13 wherein, wherein removing the sheath from within the patient includes withdrawing the sheath proximally over the signal delivery device to uncover the proximal fixation feature to allow both the distal and proximal fixation features to engage one or more respective tissues of the patient.15. The method of any of examples 12-14 wherein delivering the first electrical signal includes delivering one or more navigation signals to the patient and, subsequent to delivering the one to more navigation signals, delivering one or more tonic modulation signals to the patient, wherein the tonic modulation signals share at least one signal delivery parameter with the second electrical signal.16. The method of any of examples 12-15 wherein the one or more sheath electrodes include a first sheath electrode and a second sheath electrode, and wherein delivering-51- 184268789.1Attomey Docket No.: 132368.8037.WO00the first electrical signal includes delivering the first electrical signal between the first sheath electrode and the second sheath electrode.17. The method of any of examples 12-16 wherein the dilator includes an electrically-activatable distal tip, and wherein delivering the first electrical signal includes delivering the first electrical signal between the electrically-activatable distal tip of the dilator and one or more of the sheath electrodes.18. The method of any of examples 12-17 wherein delivering the first electrical signal includes delivering a series of alternating long and short pulses, wherein each of the long pulses have a first pulse width and wherein each of the short pulses have a second pulse width less than the first pulse width.19. The method of example 18 wherein the first pulse width is about 0.2 milliseconds and wherein the second pulse width is about 0.1 milliseconds.20. The method of any of examples 12-19 wherein the target tissue includes one or more distal branches of a hypoglossal nerve of the patient or a branch of an ansa cervicalis nerve of the patient that innervates both a sternohyoid muscle and sternothyroid muscle of the patient.

[0126] It will be appreciated that specific embodiments of the disclosed technology have been described herein for purposes of illustration, but that various modifications may be made without deviating from the technology. Certain aspects of the technology described in the context of particular embodiments may be combined or eliminated in other embodiments. Although several figures shows one or more signal delivery devices (i) in a specific orientation and (ii) positioned at least proximate to one or more specific target tissues, those of ordinary skill in the art will understand that one or more of the signal delivery devices can be position in other orientations and / or at least proximate to other target tissues, in addition to or instead of those illustrated in one or more of the foregoing figures. Further, while advantages associated with certain embodiments of the disclosed technology have been described in the context of those embodiments, other embodiments may also exhibit such advantages, and not all embodiments need necessarily exhibit such advantages to fall within the scope of the -52- 184268789.1Attomey Docket No.: 132368.8037.WO00technology. Accordingly, the disclosure and associated technology can encompass other embodiments not expressly shown or described herein.|00127] As used herein, the phrase “and / or,” as in “A” and / or “B” refers to A alone, B alone and both A and B. Unless otherwise stated, the terms "generally," "about," and "approximately" refer to values within 10% of a stated value. For example, the use of the term "about 100" refers to a range of 90 to 110, inclusive. In instances where relative terminology is used in reference to something that does not include a numerical value, the terms are given their ordinary meaning to one skilled in the art.

[0128] To the extent any materials incorporated herein by reference conflict with the present disclosure, the present disclosure controls.-53- 184268789.1

Claims

Attomey Docket No.: 132368.8037.WO00CLAIMSI / We claim:

1. A system for addressing sleep apnea in a patient, the system comprising: a delivery tool including a handle, a sheath coupled to and extending distally from the handle, and one or more sheath electrodes coupled to a distal end portion of the sheath; anda signal delivery device including a body having a proximal end portion and a distal end portion opposite the proximal end portion, one or more array electrodes coupled to the distal end portion, and a fixation feature coupled to the body at a location between the one or more array electrodes and a distal end terminus of the body,wherein the signal delivery device is configured to be received at least partially within the sheath at a position in which individual ones of the one or more array electrodes are aligned with corresponding ones of the one or more sheath electrodes and the fixation feature is positioned distally beyond the sheath.

2. The system of claim 1 wherein, when the signal delivery device is received within the sheath, individual ones of the one or more array electrodes are positioned radially inwardly from the corresponding ones of the one or more sheath electrodes.

3. The system of claim 1, further comprising a dilator configured to be received within the sheath with a distal tip of the dilator extending distally beyond the sheath, wherein, when the dilator is received within the sheath, the dilator and the sheath are configured to be advanced together toward a target tissue of a patient to create an insertion path for the signal delivery device.

4. The system of claim 3 wherein the distal tip of the dilator is electrically activatable, and wherein the system is configured to deliver one or more electrical signals between the dilator tip and the one or more sheath electrodes.-54- 184268789.1Attomey Docket No.: 132368.8037.WO005. The system of claim 1, further comprising an external pulse generator configured to be operably coupled to the one or more sheath electrodes, wherein the external pulse generator includes a processor and a non-transitory, computer-readable medium programmed with instructions that, when executed by the processor, causes the external pulse generator to deliver, via one or more of the sheath electrodes, an electrical signal comprising a plurality of first pulses and a plurality of second pulses between individual ones of the plurality of first pulses, wherein each of the plurality of first pulses have a first pulse width and where each of the plurality of second pulses have a second pulse width less than the first pulse width.

6. The system of claim 5 wherein the first pulse width is about 0.2 milliseconds and wherein the second pulse width is about 0.1 milliseconds.

7. The system of claim 5 wherein the electrical signal has a frequency of from about 1 hertz to about 3 hertz.

8. The system of claim 5 wherein the electrical signal has an amplitude of up to 5 mA.

9. The system of claim 5, further comprising a dilator configured to be received within the sheath with an electrically-activatable distal tip of the dilator extending distally beyond the sheath, wherein, when the dilator is received within the sheath, the dilator and the sheath are configured to be advanced together toward a target tissue of a patient to create an insertion path for the signal delivery device, and wherein the instructions includes instructions that, when executed by the processor, cause the external pulse generator to deliver the electrical signal via the electrically-activatable distal tip of the dilator.

10. The system of claim 1 wherein the fixation feature is a first fixation feature, wherein the signal delivery device further includes a second fixation feature positioned proximally from the one or more array electrodes, and wherein, when the signal delivery device is received within the sheath at the position, the second fixation feature is positioned within the sheath.-55- 184268789.1Attomey Docket No.: 132368.8037.WO0011. The system of claim 1 wherein the fixation feature includes a fixation body coupled to the body of the signal delivery device and a plurality of fins coupled to the fixation body, and wherein, when the signal delivery device is received at least partially within the sheath at the position, the plurality of fins are configured to transition from a collapsed state toward and / or to an extended state to at least partially prevent the one or more array electrodes from moving relative to the patient.

12. A method for addressing sleep apnea in a patient, the method comprising: percutaneously advancing a dilator and a sheath of an introducer system into a patient and toward a target tissue of the patient;delivering, via one or more sheath electrodes carried by the sheath, a first electrical signal to the patient to determine a position and / or orientation of the introducer system relative to the target tissue;determining, based at least partially on a response of the patient to the first electrical signal, that the one or more sheath electrodes are positioned at least proximate to the target tissue;removing the dilator from within the sheath;moving a signal delivery device distally through the sheath into a position in which one or more array electrodes carried by the signal delivery device are aligned with corresponding ones of the one or more sheath electrodes and in which a fixation feature coupled to the signal delivery device and located distal to the one or more array electrodes is positioned distally beyond the sheath to engage one or more tissues of the patient;withdrawing the sheath proximally over the signal delivery device to uncover all or a subset of the one or more array electrodes;delivering, via one or more of the array electrodes, a second electrical signal to the patient;determining, based at least partially on a response of the patient to the second electrical signal, that the one or more array electrodes are positioned at least proximate to the target tissue; andremoving the sheath from within the patient.-56- 184268789.1Attomey Docket No.: 132368.8037.WO0013. The method of claim 12 wherein the fixation feature is a distal fixation feature, wherein the signal delivery device further includes a proximal fixation feature coupled to the signal delivery device and located proximal to the one or more array electrodes, and wherein withdrawing the sheath proximally over the signal delivery device to uncover all or a subset of the one or more array electrodes includes withdrawing the sheath proximally over the signal delivery device while keeping the proximal fixation feature positioned within the sheath.

14. The method of claim 13 wherein, wherein removing the sheath from within the patient includes withdrawing the sheath proximally over the signal delivery device to uncover the proximal fixation feature to allow both the distal and proximal fixation features to engage one or more respective tissues of the patient.

15. The method of claim 12 wherein delivering the first electrical signal includes delivering one or more navigation signals to the patient and, subsequent to delivering the one to more navigation signals, delivering one or more tonic modulation signals to the patient, wherein the tonic modulation signals share at least one signal delivery parameter with the second electrical signal.

16. The method of claim 12 wherein the one or more sheath electrodes include a first sheath electrode and a second sheath electrode, and wherein delivering the first electrical signal includes delivering the first electrical signal between the first sheath electrode and the second sheath electrode.

17. The method of claim 12 wherein the dilator includes an electrically-activatable distal tip, and wherein delivering the first electrical signal includes delivering the first electrical signal between the electrically-activatable distal tip of the dilator and one or more of the sheath electrodes.

18. The method of claim 12 wherein delivering the first electrical signal includes delivering a series of alternating long and short pulses, wherein each of the long pulses have a first pulse width and wherein each of the short pulses have a second pulse width less than the first pulse width.-57- 184268789.1Attomey Docket No.: 132368.8037.WO0019. The method of claim 18 wherein the first pulse width is about 0.2 milliseconds and wherein the second pulse width is about 0.1 milliseconds.

20. The method of claim 12 wherein the target tissue includes one or more distal branches of a hypoglossal nerve of the patient or a branch of an ansa cervicalis nerve of the patient that innervates both a sternohyoid muscle and sternothyroid muscle of the patient.-58- 184268789.1

Images