Techniques and systems for treating sleep apnea by placing implantable electrodes - Patents.com

Abstract

Techniques for placing implantable electrodes to treat sleep apnea, as well as related devices, systems, and methods, are disclosed herein. Exemplary methods include the step of percutaneously implanting one or more signal emission devices, each at or near a corresponding target signal emission location within a patient's body. Each signal emission device may have one or more electrodes, each of which may be positioned to produce a net positive protrusive motor response of the patient's tongue. Exemplary methods may further include the step of providing power from a wearable power source to one or more of the electrodes such that the electrodes send electrical signals to the respective target signal emission locations, thereby producing a net positive protrusive motor response.

Description

[Technical field]

[0001] The present technology relates generally to techniques for placing implantable electrodes wirelessly coupled to remote power delivery devices to treat sleep apnea, and related systems and devices. Exemplary power delivery devices include mouthpieces, devices worn in collars or other neck garment form factors, and / or adhesive skin-attached devices.

[0002] [Citation to Related Applications] This application claims priority to U.S. Provisional Patent Application No. 63 / 220,335, filed July 9, 2021, and U.S. Provisional Patent Application No. 63 / 191,240, filed May 20, 2021, the disclosures of which are incorporated by reference in their entireties herein. [Background technology]

[0003] Obstructive sleep apnea (OSA) is a condition in which a patient's upper airway repeatedly becomes blocked (either partially or completely) during sleep, causing awakenings. Repeated blockages of the upper airway can cause sleep fragmentation, which can result in poor sleep, daytime fatigue, and / or lethargy. More severe cases of OSA can put patients at increased risk for stroke, cardiac arrhythmias, hypertension, and / or other disorders.

[0004] OSA is characterized by a tendency for the soft tissues of the upper airway to collapse or collapse during sleep, thereby obstructing the upper airway. OSA is typically caused by collapse of the soft palate, oropharynx, tongue, epiglottis, or a combination of these, into the patient's upper airway, which can interfere with normal breathing and / or arouse the sleep state. Summary of the Invention [Problem to be solved by the invention]

[0005] There are several treatments indicated for OSA, including, for example, surgery, continuous positive airway pressure (CPAP) machines, and electrical stimulation of the muscles associated with the upper airway that move the tongue (or other upper airway tissues). Surgical procedures include surgery to remove part of the patient's tongue and / or soft palate, and other procedures that attempt to prevent the tongue from collapsing into the back of the pharynx. These surgical procedures are highly invasive. CPAP machines apply positive air pressure at the patient's nose and mouth in an attempt to keep the upper airway open. However, these machines can be uncomfortable, cumbersome, and have low compliance rates.

[0006] Some electrical stimulation techniques attempt to prevent the tongue from collapsing into the back of the pharynx by causing the tongue to protrude anteriorly (e.g., forward) and / or flatten during sleep. However, existing techniques for electrically stimulating nerves in a patient's oral cavity have drawbacks in that they are too invasive and / or not effective enough. Thus, improved, less invasive treatments for OSA and other sleep disorders are needed. [Means for solving the problem]

[0007] According to one aspect of the invention, there is provided a method of treating a patient comprising: inserting a needle percutaneously into the patient along a trajectory toward a medial branch of the patient's hypoglossal nerve; aligning the needle with the medial branch; implanting a signal delivery device percutaneously in parallel with the medial branch via a trajectory defined by a needle, the signal delivery device having electrodes positioned to produce a net positive protrusive motor response of the patient's tongue; The electrode is positioned under the medial branch and under a retruder extending from the medial branch; and / or the retro-transducer extends away from the medial branch within a first region, and the electrode is positioned to deliver electrical stimulation to a second region opposite the first region; 1. A method comprising providing power from a wearable power source to electrodes to treat a sleep disorder in a patient, the method comprising: The step of percutaneously inserting the needle includes the steps of directing the needle into the patient's body at a subgingival location or an intraoral location and transmitting a first electrical signal through the needle to the patient; The step of providing power includes the steps of transmitting power to the electrode via an RF link and Interpulse delay from 10μs to 250μs, 0.5mA to 12mA peak-to-peak amplitude, or A first frequency within a first frequency range from 10 Hz to 500 Hz and transmitting a second electrical signal having at least one of: A method is provided in which transmitting power over the RF link includes transmitting power at a second frequency within a second frequency range of 400 MHz to 2.5 GHz.

[0008] According to another aspect of the invention there is provided a method of treating a patient, comprising the steps of: implanting a signal delivery device percutaneously at a target signal delivery location within a patient's body, the signal delivery device having electrodes positioned to produce a net positive protrusive motor response of the patient's tongue; A method is provided that includes providing power from a wearable power source to electrodes such that the electrodes deliver electrical signals to a target signal delivery location, thereby producing a net positive salient motor response.

[0009] According to yet another aspect of the present invention, there is provided a signal transmission device, comprising: Housing and an antenna positioned within the housing and configured to receive a wireless power signal via the wearable power source; a signal generator positioned within the housing and operably coupled to the antenna; and an electrode carried by the housing and operably coupled to a signal generator, the electrode extending at least partially around at least one of: (1) at least a portion of the signal generator; or (2) at least a portion of the antenna.

[0010] Representative embodiments of the present technology are illustrated by way of example, and not by way of limitation, in the figures, in which like reference characters generally indicate corresponding parts throughout. [Brief description of the drawings]

[0011] [Figure 1] FIG. 1 is a side cross-sectional view showing the upper airway of a patient. [Diagram 2] FIG. 1 is a partial schematic side cross-sectional view of a patient's upper airway illustrating components of a system for treating sleep disorders in accordance with an embodiment of the present technology. [Figure 3A] 1 is a side view of a patient's skull showing representative signal delivery targets in accordance with an embodiment of the present technology; [Figure 3B] FIG. 2 is an inferior view of a patient's skull illustrating the hypoglossal nerve and exemplary electrode placement locations in accordance with an embodiment of the present invention. [Figure 3C] 1A-1D are isometric and end views of the medial branch of the hypoglossal nerve and an associated signal sending device positioned in accordance with an embodiment of the present technology; [Figure 3D] 1A-1D are isometric and end views of the medial branch of the hypoglossal nerve and an associated signal sending device positioned in accordance with an embodiment of the present technology; [Figure 4A] 1 illustrates a manner of implanting a signal transmission device in accordance with an embodiment of the present technology. [Figure 4B] 1 illustrates a manner of implanting a signal transmission device in accordance with an embodiment of the present technology. [Figure 4C] 1 illustrates a manner of implanting a signal transmission device in accordance with an embodiment of the present technology. [Figure 4D] 1 illustrates a manner of implanting a signal transmission device in accordance with an embodiment of the present technology. [Figure 4E] 1 illustrates a manner of implanting a signal transmission device in accordance with an embodiment of the present technology. [Figure 5A] 1 is a partial schematic diagram of the cervical nerve trap, hyoglossus muscle, associated musculature, and associated signal emission devices positioned in accordance with an embodiment of the present technology; [Figure 5B] 1 is a partial schematic diagram of the cervical nerve trap, hyoglossus muscle, associated musculature, and associated signal emission devices positioned in accordance with an embodiment of the present technology; [Figure 6A] 1 is a partial schematic diagram of a signal transmission device configured in accordance with an embodiment of the present technology; [Figure 6B] 1 is a partial schematic diagram of a signal transmission device configured in accordance with an embodiment of the present technology; [Figure 6C] 1 is a partial schematic diagram of a signal transmission device configured in accordance with an embodiment of the present technology; [Figure 7A] 1A-1C are diagrams illustrating representative examples of waveforms having waveform parameters selected in accordance with embodiments of the present technology. [Figure 7B] FIG. 2 illustrates a representative example of a waveform having active and quiet periods in accordance with an embodiment of the present technology. [Figure 8] 1 is a flow chart illustrating an exemplary process for implanting and removing a signal transmission device in accordance with an exemplary embodiment of the present technology. [Figure 9] FIG. 9 is a tabular view showing representative equipment used to carry out the process shown in FIG. 8. [Figure 10A] 1 shows an exemplary ultrasound probe and associated images in accordance with an exemplary embodiment of the present technology; [Figure 10B] 1 shows an exemplary ultrasound probe and associated images in accordance with an exemplary embodiment of the present technology; [Figure 11A] 1 illustrates an exemplary ultrasound probe and associated images in accordance with an embodiment of the present technology. [Figure 11B] 1 illustrates an exemplary ultrasound probe and associated images in accordance with an embodiment of the present technology. [Figure 12] 1 is a schematic diagram of an exemplary ultrasonic probe used for a process in accordance with the present technique. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0012] For ease of reading, the technology is described under the following headings: · Heading 1 :"introduction" · Heading 2 : "Description of the overall physiological characteristics of the patient" (focus on Figure 1) · Heading 3 : "The Overall System" (Focusing on Figure 2) · Heading 4 : "Representative stimulation targets and implant techniques" (Focus on Figures 3A to 5B) · Heading 5 : "Representative signal transmission device" (focusing on Figs. 6A to 6C) · Heading 6 : "Representative Waveforms" (Focusing on Figures 7A and 7B) · Heading 7 : "Alternative implant techniques" (focus on Figures 8 to 12)

[0013] Although embodiments of the present technology are described under selected headings above, other embodiments of the present technology may include components described under multiple headings, and thus, the fact that an embodiment may be described under a particular heading does not necessarily mean that the embodiment is limited to only the components described under that heading.

[0014] 1. Introduction Electrical stimulation for obstructive sleep apnea (OSA) typically involves passing electrical current that conditions nerves and / or muscles to move the tongue and / or other soft tissues. Thus, electrical stimulation can relieve the obstruction of the upper airway and prevent the tongue or other soft tissues from collapsing or obstructing the track. As used herein, the terms "conditioning" and "stimulation" are used interchangeably to mean to refer to an effect on one or more motor functions, e.g., breathing-related motor functions, e.g., an effect on nerves that exert an influence on such motor functions.

[0015] Exemplary methods and devices for reducing the incidence and / or severity of respiratory disorders, such as OSA, are disclosed herein. According to exemplary embodiments, a minimally invasive signal-transmitting device is implanted near or adjacent to nerves that innervate the patient's oral cavity, soft palate, oropharynx, and / or epiglottis. Exemplary nerves include the hypoglossal nerve, branches of the cervical fascia, and / or vagus nerve, which are located adjacent to and / or around the oral cavity or in the neck. The signal-transmitting device may be implanted in the patient's body by percutaneous injection. A non-implanted power source, including, for example, one or more mouthpiece portions, collar portions, chin strap portions, pillow portions, mattress overlay portions, other suitable "wearables," and / or one or more adhesive skin-mounted devices, may wirelessly provide power to the implanted signal-transmitting device. The signal-transmitting device emits precisely targeted electrical signals (e.g., pulses) that improve the patient's upper airway patency and / or improve tissue tone in the oral cavity to treat sleep apnea. The electrical current delivered by the signal delivery device can stimulate at least a portion of the patient's hypoglossal nerve and / or other nerves associated with the upper airway. By moving the tongue forward and / or preventing the tongue and / or soft tissue from collapsing back onto the patient's pharynx and / or onto the upper airway, the devices and associated methods disclosed herein can improve the patient's quality of sleep, for example, by moving potentially obstructive tissues in the upper airway / pharynx down. Specifically, electrical signals can be applied to the medial branch of the hypoglossal nerve to move the tongue forward (anteriorly), and electrical signals can be applied to the cervical nerve trap to move the tongue forward (inferiorly or caudally) to the hyoid bone, thyroid (e.g., thyroid cartilage), and / or larynx down (inferiorly or caudally), a movement commonly referred to as caudal traction.

[0016] Many embodiments of the technology described below may take the form of computer-executable or machine-executable or controller-executable instructions, including routines executed by a programmable computer or controller. As will be appreciated by those skilled in the art, the technology may be implemented in computer / controller systems other than those illustrated and described below. The technology may be embodied in a special purpose computer, controller, or data processor that is specifically programmed, configured, or set up to execute one or more of the computer-executable instructions described below. Thus, as used generally herein, "computer" and "controller" refer to any suitable data processor, and these terms may include Internet applications and handheld devices (palmtop computers, wearable computers, tablets, mobile phones, mobile phones, multiprocessor systems, processor-based consumer electronics, programmable consumer electronics, network computers, minicomputers, etc.). Information manipulated by these computers may be presented on any suitable display medium, including liquid crystal displays (LCDs).

[0017] The technology can also be practiced in a distributed environment, where tasks or modules are performed by remote processing devices that are linked together through a communications network. In a distributed computing environment, program modules or subroutines can be implemented in local and remote storage devices. Aspects of the technology described below can be stored or distributed on any suitable computer-readable medium, including one or more ASICs (e.g., with addressable memory), and can be electronically distributed over a network. Data structures and data transmissions specific to aspects of the technology are also within the scope of embodiments of the technology.

[0018] 2. Physiological characteristics of representative patients Representative embodiments described herein include a signal delivery device having electrodes that may be positioned to deliver one or more electrical currents to one or more specific target placement locations, such as specific nerves and / or specific locations along the nerves. FIG. 1 illustrates the general anatomy of a patient's oral cavity, with subsequent figures illustrating specific target locations. Such locations include locations along the patient's hypoglossal nerve, branches of the cervical fasciculus, and / or vagus nerve, such as nerves that innervate airway muscles other than the tongue (e.g., palatine, oropharyngeal, laryngeal, omohyoid, sternohyoid, and / or sternothyroid muscles). Target locations may be identified relative to any of the intrinsic muscles, extrinsic muscles, associated nerve branches, and / or other physiological features, or any combination thereof. Such target locations and / or positions may also be located away from salivary glands (e.g., located inside the sublingual salivary glands) and / or other structures to avoid causing pain and / or other undesirable effects.

[0019] FIG. 1 illustrates a patient P relative to a coordinate system in which the x-axis indicates an anterior-posterior direction, the y-axis indicates a superior-inferior direction, and the z-axis indicates a medial-lateral direction. The patient P has a hard palate HP that is located above the tongue T and forms the roof of the oral cavity OC (e.g., the mouth). The hard palate HP has a bony support BS and thus does not normally deform during breathing. The soft palate SP, which is made of soft tissues, e.g., membranes, fibrous, fatty tissue, and muscle tissue, extends posteriorly (e.g., posteriorly) from the hard palate HP toward the back of the pharynx PHR. More specifically, the anterior end AE of the soft palate SP is fixed to the posterior end of the hard palate HP, and the posterior end PE of the soft palate SP is non-fixed. Because the soft palate SP does not include bone or hard cartilage, the soft palate SP can flex and collapse into the back of the pharynx PHR and / or flop back and forth (e.g., especially during sleep).

[0020] The pharynx PHR, which transports air from the oral cavity OC and nasal cavity NC to the trachea TR, is a portion of the throat located below (inferior to) the nasal cavity NC, behind (behind) the oral cavity OC, and above (above) the esophagus ES. The pharynx PHR is separated from the oral cavity OC by the palatoglossal arches PGA, which extend downward on both sides toward the base of the tongue T. Although not shown for simplicity, the pharynx PHR includes the nasopharynx, oropharynx, and laryngopharynx. The nasopharynx is located between the superior surface of the soft palate SP and the wall of the throat (i.e., above the oral cavity OC). The oropharynx is located behind the oral cavity OC and extends from the uvula U to the level of the hyoid bone HB. The oropharynx opens anteriorly into the oral cavity OC. The lateral walls of the oropharynx consist of the palatine tonsils and are located between the palatoglossal arches PGA and the palatopharyngeal arches. The anterior wall of the oropharynx consists of the base of the tongue T and the epiglottic vallecula. As both food and air pass through the pharynx PHR, when food is swallowed, a flap of connective tissue called the epiglottis EP covers the glottis (not shown for simplicity) to prevent aspiration. The larynx is the part of the throat that connects to the esophagus ES and is located below the epiglottis EP. Beneath the tongue T is the lower jaw or mandible M and the geniohyoid muscle GH, which is one of the muscles that control the movement of the tongue T. The genioglossus muscle also controls tongue movement and is a particular target of the presently disclosed therapy, which is described below with reference to FIG. 4B.

[0021] 3. Overall System FIG. 2 is a partial schematic isometric view of system 100 in relation to a patient's anatomy in a similar perspective to that described above with reference to FIG. 1. In an exemplary embodiment, system 100 includes both implanted and external components. The implanted components may include one or more implantable devices 120. Each implantable device 120 may have a signal transmission device 130 positioned adjacent a target nerve and / or muscle structure. The signal transmission device 130 may be secured in place by sutures and / or other devices, such as anchors. Signal transmission device anchors may include, for example, one or more tines, helices, mesh coverings, expandable stents, and others. The signal transmission device 130 is operably coupled to a signal generator 110. In some embodiments, all of the signal generation functions are performed by the implantable device 120, while in other embodiments, some of the signal generation functions may be performed by external components. The signal generation and signal delivery functions may be performed by a single implantable device 120 or by multiple devices.

[0022] The system 100 may further include a wearable device 101 with a power source 109. For illustrative purposes, the wearable device 101 is shown in FIG. 2 as including an intraoral device 123, e.g., a mouthpiece, which carries the power source 109. As mentioned above, the wearable device 101 may have other suitable forms in other embodiments, such as a collar, a chin strap, a pillow, a mattress overlay, among others. The power source 109 provides power to the signal generator 110, which generates and directs signals (e.g., therapeutic signals) to one or more electrodes 131 carried by a signal transmission device 130. The signal transmission device 130 may be implanted at or near a target nerve, e.g., the patient's hypoglossal nerve HGN, using minimally invasive techniques, e.g., using a hypodermic needle, as described below under heading 4. The power source 109 provides power to the signal generator 110 via a wireless power transmission link 114, for example an RF transmission link configured to provide power wirelessly at any of the frequencies and / or frequency ranges described below under heading 5, and / or any other suitable frequency / frequency range.

[0023] Elements carried by wearable device 101 and (directly or indirectly) implantable device 120 may be controlled by programmer 160 via wireless programmer link 161. Additionally, programmer 160 may communicate with cloud 162 and / or other computer services to upload data received from patient P and / or download information to wearable device 101 and / or implantable device 120. The downloaded data may include instructions regarding appropriate treatment and / or other data (e.g., from other similarly situated patients), updates for software executed on circuitry carried by wearable device 101 and / or implantable device 120, and / or other useful information. In other embodiments, implantable device 120 and / or wearable device 101 include state machine components that cannot be updated. Representative downloaded data received from the patient may include respiratory rate, heart rate, audio signals (corresponding to audible snoring, hypopnea events, and / or apnea events), body temperature, head orientation / position, saturated blood oxygen levels, airflow levels, thyroid movements, and / or tongue movements. For any of the above embodiments, the wearable device 101 transmits power to the implantable device 120 via one or more power transmission links 114 and receives power (e.g., in an intermittent manner) from a charger 121. The charger 121 may thus include a conventional inductive coupling type (e.g., Qi standard charging type) and / or a conventional wired connection type.

[0024] For comfortable wear, the wearable appliance 101 (whether an oral appliance 123 or other type of wearable) may be custom-fitted to the patient or may be made available in a variety of sizes and / or may be partially configurable to fit an individual patient. The oral appliance 123 is best suited when the associated signal emitter 130 is positioned at or near a target nerve population (e.g., HGN) in the oral cavity. A representative oral appliance is disclosed in pending U.S. patent application Ser. No. 17 / 518,414, filed Nov. 3, 2021, the disclosure of which is incorporated by reference herein in its entirety. Whether the wearable appliance has a mouthpiece form factor or another suitable form factor, power may be provided to the implantable appliance 120 even when the wearable appliance is used to target nerve populations other than and / or in addition to the HGN, such as branches of the vagus nerve and / or jaw nerve trap. In yet another embodiment, the power source 109 may be attached to the patient's skin by an adhesive, although it is anticipated that avoiding adhesives may be more desirable / effective for the patient.

[0025] With reference to the particular embodiment shown in FIG. 2, the oral appliance 123 may have both an upper mouthpiece portion 111 and a lower mouthpiece portion 112. The two mouthpiece portions 111, 112 may be coupled together by a connector 113. The connector 113 may provide a wired communication link between the two mouthpiece portions and / or the connector 113 may mechanically position (and / or maintain or stabilize) the lower mouthpiece portion 112 relative to the upper mouthpiece portion 111. Using this approach, for example, the patient's lower jaw or mandible M may be advanced relative to the patient's upper jaw as indicated by the bony structure BS in FIG. 2. For example, embodiments of the present technology use physical elements of the wearable appliance 101 in addition to electrical stimulation powered by the wearable appliance to avoid or at least reduce jaw relaxation (a state in which the patient's mouth is gaping). For example, a wearable appliance with a collar and / or chin strap may mechanically stabilize the patient's jaw in a target position.

[0026] The power source 109 may include one or more charge storage devices 116 (e.g., one or more batteries) that receive power from the charger 121 and store the power for transfer to the signal implantable device 120. Thus, the power source 109 may include circuitry 115 (e.g., a first circuitry) that receives power from the charge storage device 116, conditions the power (e.g., converts the power from a DC to an RF waveform), and transfers the power to the transmitting antenna 118. The transmitting antenna 118 transfers the power to the implantable device 120 via a wireless power transmission link 114 (e.g., an RF transmission link) and an electrode receiver antenna 133 carried by the signal transmission device 130.

[0027] The oral appliance 123 may further include a data transceiver antenna for receiving data from and / or transmitting data to the programmer 160. The data transmitted to the programmer 160 may include sensor data obtained from one or more sensors 119. Thus, the oral appliance 123 may carry the necessary functional elements / components to direct power to the signal transmitting device 130 and communicate with the programmer 160 to provide an effective treatment for the patient.

[0028] 4. Representative stimulation targets and implantation techniques Several stimulation targets and implantation techniques are described and / or illustrated with reference to FIGS. 3A-5. For ease of illustration, the stimulation targets and implantation techniques are illustrated with respect to the left or right side of the patient P's anatomy, e.g., the left medial branch of the patient P's left hypoglossal nerve. However, it will be appreciated that at least some or all of the stimulation targets and / or implantation techniques described and / or illustrated with reference to FIGS. 3A-5 are equally suitable for application to the other side of the patient's anatomy, e.g., the right medial branch of the patient P's right hypoglossal nerve. Additionally, at least some of the stimulation targets and / or implantation techniques can be used for bilateral signal delivery, e.g., to apply a first electrical signal to a first stimulation target on a first side of the patient P and a second electrical signal to a second stimulation target on a different side of the patient P. In some embodiments, the first and second stimulation targets can be corresponding left and right portions of the patient's anatomy, e.g., the left and right medial branches of the left and right hypoglossal nerves. In other embodiments, the first and second stimulation targets may be different from one another, for example, the left medial branch of the left hypoglossal nerve and the right cervical nerve antrum of the patient.

[0029] Figure 3A is a schematic, partially cut away sagittal view of the cervical and inferior head regions of patient P. Figure 3A shows representative neural structures in this region, including the hypoglossal nerve HGN (and its medial branch 180) and the cervical nerve AC. Figure 3A also shows a representative ultrasound probe 199 that is used to aid in the process of positioning electrodes that will direct therapeutic signals to the target nerve.

[0030] FIG. 3B is a partial schematic isometric view of a patient's skull looking upward toward the mandible M. FIG. 3B also shows the hypoglossal nerve HGN, which innervates the muscles that control the patient's tongue T (FIG. 1). In a representative embodiment, one or more electrodes 131 are positioned along the hypoglossal nerve HGN in an electrode plane 132 defined by the medial branch, and in particular at the medial branch 180 of the HGN. By precisely positioning the electrodes 131 in this plane 132 and adjacent to the hypoglossal nerve HGN, systems according to embodiments of the present technology can more effectively control the patient's airway patency without causing discomfort and / or other undesirable effects and / or in a manner that reduces the amount of power required to produce an effective therapeutic signal. As described elsewhere herein, other representative target nerves include the cervical fascia and vagus nerves, and / or one or more of the muscles innervated by these nerves. Further representative targets include the cranial nerves (e.g., glossopharyngeal nerve) and palatoglossus muscle shown in FIG. 3A, as well as the left and / or right phrenic nerves.

[0031] 3C is a partial schematic diagram of the medial branch 180 and associated signal delivery device 130 positioned in accordance with embodiments of the present invention. The medial branch 180 extends along a nerve axis 181 and innervates oral muscles, such as the genioglossus and geniohyoid, which tend to pull the tongue forward, thus reducing the tendency of the soft tissue of the palate to prolapse into the patient's airway. However, the medial branch 180 further includes a retruser 182, which innervates muscles such as the styloglossus and hyoglossus, which tend to pull the soft tissue backward and / or may cause the tongue to roll left or right in the oral cavity - both motor responses that may obstruct the patient's airway. It is therefore advantageous to stimulate the medial branch 180 with the electrode 131 in a manner that results in a net positive protrusive effect or a net protrusive motor response. This may include, for example, stimulating the medial branch 180 to avoid activation of the entire Letruzer 182. Additionally or alternatively, a net positive protrusive effect may be obtained when the protrusive response to the electrical signal is greater than or otherwise counteracts the retractive response to the electrical signal. This may include, for example, sending an electrical signal to one or more of the patient's nerves and / or muscles to open the patient's airway more in response to the electrical signal and / or allow a greater amount of air to be achieved than if the electrical signal were not sent. One way to obtain a net positive protrusive effect is to position the electrodes 131 such that they preferentially stimulate the medial branch 180 without stimulating (or significantly stimulating) the Letruzer 182.

[0032] As shown in FIG. 3C, the letruzer 182 has a first portion 183a that generally extends parallel or at least partially parallel to the nerve axis 181 of the medial branch 180. The letruzer 182 further has a second portion 183b that curves away from the nerve axis 181. Thus, one way to avoid or reduce stimulation of the letruzer 182 is to axially position the electrodes 131 such that the electric field they produce is less likely to activate the letruzer 182. As shown in FIG. 3C, the electrodes 131 are arranged in electrode pairs, including a first pair (comprising first and second electrodes 131a, 131b) and a second pair (comprising third and fourth electrodes 131c, 131d). Other embodiments may include more or fewer electrodes and / or electrode pairs. Each electrode pair generates an electric field E, which decreases in strength away from the electrode 131, as indicated by the tapering field strength arrows 171. The electric field E preferentially activates neural tissue that extends transversely to the electric field over neural tissue that is parallel to the electric field. Thus, with the device axis 141 of the signal sending device 130 approximately parallel to the neural axis 181 of the medial branch 180, the electric field E preferentially activates the medial branch 180. However, if the electric field E is positioned adjacent to the first portion 183a of the retruzer 182 (which are also parallel or approximately parallel to the neural axis 181), the electric field E may also activate the retruzer 182. One way to avoid this outcome is to position the electrode 131 offset along the neural axis 181 relative to the first portion 183a of the retruzer 182. In this manner, the electric field E is less likely to activate the Letruzer 182 at the first portion 183a. Although the second portion 183b of the Letruzer 182 is transverse to the electric field (and therefore potentially susceptible to the electric field), the electric field at the second portion 183b is so weak that it is not expected to have a significant effect on the Letruzer 182.In these and other embodiments, one or more of the electrodes 131 can be masked (e.g., circumferentially masked), segmented (e.g., circumferentially segmented and individually addressable), directional, at least partially covered, and / or otherwise configured to direct the electric field in a particular direction to further reduce the risk of stimulating the retractor 182.

[0033] Another way to reduce the effect of the electric field on the retruzer 182 is to selectively position the electrodes circumferentially, as shown in Figure 3D. As shown in Figure 3D, the retruzer 182 tends to exit the inner branch 180 in a generally upward direction, so the signal sending device 130 is positioned below the inner branch 180. Thus, if the retruzer 182 extends away from the inner branch 180 in the first region 142a at a clockwise position from about 10 o'clock to about 2 o'clock (measured clockwise), the signal sending device 130 may be positioned in a second region 142b spaced apart (e.g., axially offset, opposite, etc.) from the first region 142a, i.e., between about 2 o'clock and about 10 o'clock (measured clockwise), and / or any suitable sub-region within such region (e.g., between any of the clockwise positions of 2 o'clock, 3 o'clock, 4 o'clock, 5 o'clock, 6 o'clock, 7 o'clock, 8 o'clock, 9 o'clock, and 10 o'clock). If the letruser 182 extends in a generally inferior direction from the inner branch 180 , the signal emission device 130 may be positioned generally above the inner branch 180 .

[0034] Yet another way to reduce the effect of the electric field on the Letruza 182 is to position the electrodes at or near the motor endplate of the target nerve, such as where the HGN innervates the patient's tongue and / or at or within the genioglossus muscle. For example, the signal sending device 130 may be positioned close to and / or adjacent to a brachiated portion of the patient's target nerve, as will be described in more detail with reference to FIG. 4D. With the signal sending device 130 in this position, the electric field E generated by the signal sending device 130 is spaced away from the Letruza 182, and it is expected that the electric field will be too weak to have a significant effect on the Letruza 182. In some aspects, positioning the signal sending device 130 further forward, such as further back into the brachiated portion of the patient's target nerve, may further focus the electric field on the target nerve and / or further reduce the risk of stimulating the Letruza 182. The techniques described above (axial alignment, circumferential "clocking", and brachial positioning) can be used either individually or in combination, and using these techniques in combination is expected to further reduce the risk of activating the Letrusa 182.

[0035] As noted above, careful positioning of the electrodes can be important to enhance the beneficial effects associated with electrical therapy and reduce detrimental effects, such as activation of the Letrusa 182. Example A, described under heading 7, discloses a technique for percutaneously introducing and positioning a signal delivery device via a single entry site with the aid of an ultrasound probe (as shown in FIG. 3A).

[0036] In one method, a single puncture is made in the patient's skin using a stylet. The puncture may be placed in the patient's posterior submandibular area. A signal delivery device 130 may be percutaneously introduced (e.g., implanted, injected, and / or otherwise) through the posterior submandibular puncture and positioned adjacent to the medial branch 180 of the hypoglossal nerve HGN.

[0037] In another approach, a single puncture is made in the patient's oral cavity using a stylet. The puncture may be placed in the patient's oral sublingual area, e.g., below the sublingual surface of the floor of the mouth, posterior to the sublingual caruncle, and angled medially toward the medial branch of the hypoglossal nerve. The signal delivery device 130 may be percutaneously introduced through the oral sublingual puncture and positioned proximate to the medial branch 180 of the hypoglossal nerve HGN.

[0038] Another approach, described below with reference to Figures 4A-4C, uses a stylet and two punctures in the patient's skin to position the signal transmission device 130. The stylet may be curved or straight, or have any other suitable shape. In certain embodiments, the signal transmission device may have sutures located at each end, so that the physician can pull on one end and / or the other to precisely position the signal transmission device (and the electrodes it carries) at the target location.

[0039] FIG. 4A illustrates a representative set of implant tools 190 used to implant an implantable device 120 in accordance with embodiments of the present technology. The implantable device 120 includes a signal sending device 130 having electrodes 131 that provide electrical stimulation to a target neural population. In some embodiments, for example, as illustrated in FIGS. 5A, 6A, and 6B, the signal sending device 130 includes leads 134 carrying the electrodes 131. In other embodiments, for example, as illustrated in FIGS. 5B and 6C, the leads 134 may be omitted and the signal sending device 130 may be “leadless” and / or carry electrodes 131 disposed on an outer surface of the signal sending device 130 such that one or more components of the signal sending device 130 may be positioned within one or more of the electrodes 131 (e.g., radially inward from the electrodes or within an annular area of ​​the electrodes). One end of the implantable device 120 is attached to proximal suture 193a and the opposite end is attached to distal suture 193b (collectively referred to as sutures 193). The implantable device 120 may further include one or more anchors 137, shown as proximal anchor 137a and distal anchor 137b. In at least some embodiments, anchors 137 may be omitted since the implantable device 120 is held in place via both proximal suture 193a and distal suture 193b.

[0040] The proximal suture 193a is attached to a curved needle 191. Depending on the size and shape of the implantable device 120, the implant tool may further include a dilator 196, an introducer 192, which may include a cannula through which the implantable device 120 may be positioned within the patient, and / or other percutaneous insertion devices configured to facilitate directing the implantable device 120 into the opening formed by the needle 191, for example, by the Seldinger technique. For example, the introducer 192 may form a percutaneous insertion path through the patient's skin through which the implantable device 120 may be percutaneously inserted, implanted, injected, and / or otherwise. Whether the needle 191 is curved (as shown in FIG. 4A) or straight (as may be the case in other embodiments), the needle may have a diameter ranging from 20 gauge to 10 gauge, or in certain embodiments, from 18 gauge to 12 gauge. The diameter of the dilator 196 may range from 3 French to 12 French (1 mm to 4 mm). The needle 191 and / or introducer 192 may be initially inserted at a relatively steep trajectory angle (e.g., 60° relative to the skin surface) and then lowered to a shallower angle (e.g., 20° relative to the skin surface) toward the skin to align the needle with the HGN. Once a portion of the needle 191 is percutaneously inserted, the insertion trajectory of the needle 191 (and / or other percutaneous insertion device, such as introducer 192) may be adjusted to avoid the needle 191 contacting other structures (e.g., the mandible) along its insertion trajectory and / or to reduce or eliminate the risk of puncturing other non-target portions of the patient's anatomy (e.g., salivary glands, vascular structures, nerves, mandible, etc.). For example, the need to change the entry angle may be reduced or eliminated if the needle 191 is curved as described above.

[0041] In some embodiments, the needle 191 and / or another percutaneous insertion device may be configured to stimulate the patient's tissue during insertion. For example, as shown in FIG. 4A, the needle 191 may have one or more electrodes 197 positioned at or near a distal end 198 of the needle 191. To identify the exact location of the needle, an electrical stimulus may be sent through the needle to the patient and the patient's motor response may be observed. The attending physician may use ultrasound and / or another suitable visualization technique in addition to or in lieu of eliciting a motor response. Thus, in at least some embodiments, the attending physician may use a combination of visual navigation and stimulus-response navigation to precisely align the needle with the HGN (or other target nerve) such that, when the implantable device 120 is introduced, the implantable device 120 is likely to be closer to and / or more closely aligned with the HGN. In some embodiments, the attending physician can use stimulus-responsive navigation to identify the location of the needle when operating within some parts of the patient's anatomy where the needle 191 is difficult to see (e.g., with ultrasound), such as near / within the brachiation of the HGN.

[0042] Depending on the embodiment, the above-mentioned elements may be axially offset or may be pre-scored and stripped away. In operation, the needle 191 is directed into the patient's tissue at a first location, forming a first opening. The needle may exit the patient's tissue at a second location, thereby forming a second opening. The attending physician may then pull the implantable device 120 through the first opening with the needle 191, and may use the proximal and distal sutures 193a, 193b to more precisely position the implantable device 120 within the patient's body. Additionally or alternatively, the needle 191 may be hollow, such that the implantable device 120 may be positioned within the patient's body by inserting the implantable device 120 into the needle 191 and percutaneously inserting the implantable device 120 into the patient's body with or without the sutures 193a, 193b and / or via a single opening. In these and other embodiments, one or more other percutaneous insertion devices, such as introducer 192, dilator 196, and / or cannula, may be inserted over and along needle 191 to aid in percutaneous insertion of implantable device 120. For example, the needle may be used to stimulate tissue to identify an implantation site and facilitate placement of one or more dilators and / or cannula over the needle, and thus position a cannula configured to deliver the implantable device to the implantation site. In these and other embodiments, needle 191 may optionally include a lumen and / or an atraumatic tip. In at least some embodiments, the needle may be configured to act as a dilator to directly deliver the cannula, such that dilator 196 may be omitted.

[0043] FIG. 4B is a close-up view of the patient's mandible, showing the longitudinal and transverse muscles of the tongue T, as well as the genioglossus, geniohyoid, and mylohyoid muscles. The implantable device 120 is shown after it has been inserted into the patient P via needle 191 (FIG. 4A) such that it is positioned below the genioglossus at the intersection of the geniohyoid and genioglossus muscles. The signal sending device 130 is also located adjacent to the medial branch 180, which is shown in schematic dashed lines. The needle 191 has been introduced into the patient by forming a distal opening 195b and has exited the patient at a proximal opening 195a. In other embodiments, the needle 191 can be introduced into the patient via the proximal opening 195a and can exit the patient via the distal opening 195b. 4B shows both the proximal and distal openings 195a, 195b as being formed within the patient's submandibular space, in other embodiments, the proximal and / or distal openings 195a, 195b may be formed intraoral, sublingual, and / or in any other suitable location. In at least some embodiments, for example, the needle 191 may be introduced into the patient via a submandibular opening and may exit the patient via an intraoral sublingual opening.

[0044] After removal of the needle 191 and any dilators or introducers, the remaining proximal and distal sutures 193a, 193b exit the patient P at the proximal and distal openings 195a, 195b, respectively. Alternatively, the physician can gently pull on each of the sutures 193a, 193b in turn, as indicated by the arrows S, to position the signal delivery device 130 at a precise location relative to the medial branch 180 (shown diagrammatically in dotted lines in FIG. 4B). Allowing the physician to move the signal delivery device 130 by pulling (e.g., as opposed to pushing) is expected to improve the precision with which the physician can adjust the position of the signal delivery device relative to the medial branch 180. These precise locations can be determined by applying electrical signals to the signal delivery device and observing the patient's motor response, as described above with respect to the needle 191. The physician can use ultrasound and / or another suitable visualization technique in addition to or in place of eliciting a motor response. Any of these techniques may be performed iteratively until the electrodes are properly positioned. For example, in a typical process, the attending physician uses ultrasound to position the signaling device 130 near the target location, and then repeatedly applies electrical signals while wiggling the signaling device and observing the patient's motor response until the target location is precisely identified.

[0045] 4C, the signal sending device 130 is positioned at a target location relative to the medial branch 180. Proximal suture 193a is attached to the patient P at proximal suture point 194a, and distal suture 193b is attached to the patient P at distal suture point 194b. Suture points 194a, 194b may be shortened so as not to extend through openings 195a, 195b, may be placed subcutaneously but close to the patient's skin for easy withdrawal if necessary, and / or may be elastic and / or otherwise configured to allow slight movement of the signal sending device 130 once attached to the patient P. In certain embodiments, the sutures (e.g., sutures 193a, 193b, and / or other suture elements) may be made radiopaque or echogenic under fluoroscopy and / or ultrasound to be more visible under fluoroscopy and / or ultrasound. For example, the sutures may be secured with a fluoroscopic T-bar that is initially collapsed and then expanded into adjacent tissue when in place. Additionally or alternatively, one or both of the sutures 193a, 193b may be biodegradable. In these and other embodiments, one or more anchors 137 (shown in FIG. 4A) may be deployed to secure the implantable device 120 in place.

[0046] 4D is another view of the implantable device 120 with the signaling device 130 positioned to direct an electric field toward the medial branch 180 of the hypoglossal nerve HGN. As shown in FIG. 4C, the signaling device 130 may be positioned between the planes defined by the mylohyoid muscle (which is out of the plane of FIG. 4D), the genioglossus muscle, and the hyoglossus muscle. Thus, in some embodiments, the signaling device 130 may be positioned against or near the surface of the genioglossus muscle without penetrating into the genioglossus muscle. In other embodiments, the signaling device 130 may penetrate into the genioglossus muscle, which may help support the signaling device at its target location. The signal sending device 130 may be positioned anterior to the anterior edge of the mylohyoid muscle to direct the therapeutic signal to the medial ramus 180 (as shown in FIG. 4D ), and / or may have other suitable locations, such as a location near the medial ramus 180 (as shown in FIGS. 3C and 3D ). In some embodiments, the implantable device 120 may be positioned anteriorly relative to the location shown in FIG. 4D , such that the signal sending device 130 can be positioned to direct an electric field toward one or more ramus 184a, 184b of the HGN and / or at or proximate to the motor endplate of the HGN and / or one or more of the ramus 184a, 184b of the HGN that innervates the tongue T. For example, in addition to or instead of positioning the implantable devices 120 as shown, a first implantable device 120a (shown diagrammatically) may be positioned in a position such that a first signal sending device 130a (shown diagrammatically) is positioned to direct an electric field toward a first branch 184a of the HGN, and / or a second implantable device 120b (shown diagrammatically) may be positioned in a position such that a second signal sending device 130b (shown diagrammatically) is positioned to direct an electric field toward a second branch 184a of the HGN.

[0047] Figure 4E is a coronal view of a patient's mouth, showing the implantable appliance 120 in a representative position. The appliance 120 is shown in cross section extending into and out of the plane of the page in Figure 4E. In this position, the appliance 120 is located just lateral to the hyoglossus muscle and just medial to the mylohyoid bone, at or near where the planes of the hyoglossus and mylohyoid intersect. The appliance 120 is positioned just below the HGN, which is also shown in cross section extending into and out of the plane of the page in Figure 4E.

[0048] One advantage of the above approach is that the physician can move the signal sending device 130 back and forth to find the exact target location without having to create an incision in the patient. Instead, the signal sending device is introduced percutaneously into the patient, which can improve patient outcomes, for example, by reducing the risk of spreading infection. Additionally, anchors 137 (FIG. 4A) may be used to secure the signal sending device 130 in place, although in at least some embodiments, sutures 193a, 193b are sufficient to do this. In yet other embodiments, the signal sending device 130 can be held in place simply by forces provided by the mylohyoid, genioglossus, and hyoglossus muscles, or by penetrating the genioglossus with sutures and / or other anchoring devices as described above. Furthermore, with any of the above embodiments, the signal generation and signal sending functions can be performed by initially separate elements that are joined together during the implantation process, as described in more detail with reference to FIG. 6B.

[0049] Any of the techniques described herein for implanting the signal delivery device 130 may include one or more additional manipulations. For example, the physician may compress or otherwise manipulate (e.g., with the physician's finger) the submandibular or intraoral tissue to facilitate positioning of the signal delivery device. These methods allow the physician to manipulate the trajectory of the implantation needle toward the desired endpoint. The additional force may be in the form of manual pressure applied within or outside the oral cavity and / or a vacuum intended to move tissue as a way to improve the accuracy of implantation of the signal delivery device. Pressure and / or suction may also be used to avoid structures such as glands.

[0050] The above description with reference to Figures 3A-4E has focused on electrodes positioned to deliver signals to the medial branch of the hypoglossal nerve 180. As discussed above, it is expected that in addition to or instead of applying a signal to the medial branch, it will be advantageous to apply an electrical signal to the cervical nerve trap and / or directly to one or more of the muscles innervated by the cervical nerve trap. Figure 5A is a partial schematic diagram of the hypoglossal nerve and cervical nerve trap, showing three branches of the cervical nerve trap that innervate the omohyoid, sternothyroid, and sternohyoid muscles. Figure 5A also shows three representative signal delivery devices 130 (shown as devices 130a, 130b, and 130c), each of which is positioned to direct an electrical signal to a respective one of the nerve branches. In the illustrated embodiment, each signal sending device 130 may include a lead body 134 carrying electrodes positioned to direct a signal to a corresponding nerve, and a housing 135 carrying elements for receiving power from a remote source and generating a signal that is then provided to the electrodes. In other embodiments, as described above in connection with FIG. 4A, the lead body 134 may be omitted and the electrodes may be carried by the housing 135, thereby reducing the overall size (e.g., length) of the implantable device and improving the ability of the attending physician to accurately position the signal sending device 130 at or near the target nerve. The techniques described above with reference to FIGS. 4A-4C may also be used to position the signal sending device 130 near the cervical nerve trap. Further details of an exemplary signal sending device 130 suitable for any of the above locations are described below with reference to FIGS. 6A-6C.

[0051] In some embodiments, the electrical signal can be applied to multiple different targets. For example, FIG. 5B shows two signal-emitting devices 230 (individually shown as a first signal-emitting device 230a and a second signal-emitting device 230b, which will be described in detail with reference to FIG. 6C). The first signal-emitting device 230a is positioned to send a first electrical signal (schematically shown as a first electric field E1) to the medial branch 180 of the hypoglossal nerve HGN, and the second signal-emitting device 230b is positioned to send a second electrical signal (schematically shown as a second electric field E2) to the cervical nerve trap AC. In other embodiments, the first signal-emitting device 230a and / or the second signal-emitting device 230b may be positioned to directly stimulate one or more of the muscles at or near their respective corresponding locations. For example, a first signal emitting device 130a can be positioned to transmit a first electrical signal / field E1 to the hyoglossus and / or genioglossus muscles, and / or a second signal emitting device 130b can be positioned to transmit a second electrical signal / field E2 to the thyrohyoid, sternohyoid, omohyoid, and / or sternothyroid muscles. Although the signal emitting device 230 shown in FIG. 5B is leadless, in other embodiments, a leaded signal emitting device, such as the signal emitting device 130, can be positioned as shown in FIG. 5B.

[0052] 5. Representative signal transmission devices FIG. 6A is a partial schematic side view of an implantable device 120 with elements configured in accordance with a representative embodiment of the present technology. In the embodiment shown in FIG. 6A, a single implantable device 120 performs both signal generation and signal transmission functions. Thus, the implantable device 120 has both an implantable signal transmission device 130 and an implantable signal generator 110. Representative dimensions are shown in FIG. 6A to provide a sense of scale, but the present technology is not limited by these dimensions unless expressly specified. The signal transmission device 130 has a lead body 134 that can be generally flexible and can carry one or more electrodes 131, which in some embodiments can be generally rigid and in other embodiments can be flexible. The flexible electrodes increase the flexibility of the entire lead body to accommodate tortuous anatomical structures / insertion paths near the target nerve. For purposes of illustration, the lead body 134 is shown in FIG. 6A as carrying four electrodes 131, however, in other embodiments, the lead body 134 can carry any other suitable number of electrodes, for example, two electrodes 131. The electrodes 131 may be arranged in an array, for example, in a one-dimensional linear array. The electrodes 131 may include conventional ring-shaped or cylindrical electrodes made of a suitable biocompatible material, for example, platinum / iridium, stainless steel, MP35N, and / or other suitable conductive implant materials. The electrodes 131 may each be coupled to an individual conductor 140, for example, a thin wire filament, that passes through the lead body 134. Each electrode 131 may have a length of approximately 1.5 mm as shown in FIG. 6A, or may have another suitable length in other embodiments. In certain embodiments, portions of the electrodes may be directional, circumferentially masked, and / or segmented to more precisely target the electric field in a clockwise or counterclockwise direction about the longitudinal axis of the lead body 134. This technique can be used to direct the electric field away from the letrusa (as discussed above with reference to Figures 3C and 3D) and / or to avoid the alveolar nerve and / or other nearby sensory nerves.In this manner, the electrode 131 is rotated (or the rotational position of the electrode 131 is maintained) to have the correct clock position for the target neural population.

[0053] In the embodiment shown in FIG. 6A, the lead body 134 is connected to and carried by a housing 135, which carries the signal generator 110 and circuitry for receiving power. For example, the overall housing 135 may include an antenna housing or housing portion 135a and a circuit housing or circuit housing portion 135b. The antenna housing 135a may be flexible and may carry a receiver antenna 133 (or other suitable power receiving device) that receives power from the wearable device 101 (FIG. 2) via a wireless transmission link 114. The circuit housing 135b may be in the form of a generally circular metal "can" made of titanium, platinum, platinum-iridium alloy, ceramic, and / or another suitable material and / or combination thereof. The signal generator 110 may include a charge pump and / or DC-DC converter 139 and / or circuitry 138 (e.g., a second circuitry portion) coupled to the receiver antenna 133. In some embodiments, the electrode receiver antenna 133 may be coupled to an AC-DC converter configured to convert the received power signal (e.g., via the RF transmission link 114 shown in FIG. 2) to a DC current. The circuitry 138 may include an ASIC that may include corresponding machine-readable instructions. The instructions may be updated wirelessly using the electrode receiver antenna 133 for data transmission in addition to power transmission. For example, the data may be transmitted using pulse width modulation (PWM) and / or other suitable techniques. Data may also be transmitted in the reverse direction, for example, using backscatter and / or other suitable techniques. For example, the implantable device 120 may transmit a receipt indicating that it has received power and how much power it has. This information may be used to self-adjust (up or down) the output of the signal generator 110, for example, the transmitted signal and phase. Thus, the circuitry 138 may include a processor and memory, including pre-programmed and updatable instructions (e.g., in the form of an ASIC), for delivering a therapeutic signal to the patient. For example, the system may include a boot loader embedded firmware.Additionally, the entire system can use RFID-based power transmission authentication to identify multiple implantable devices that may be powered by a single wearable device 101. Using RFID and / or other technologies, security measures can be implemented to prevent foreign or unintended stimulation. Such technology can, at least in some embodiments, be implemented by appropriate hardware / software implemented in the implantable device 120.

[0054] The overall housing 135 may further include a generally rigid base 136 and one or more anchors 137. The anchors 137 may be used in addition to or in place of the sutures shown in FIG. 4C to securely position the implantable device 120 relative to the patient's tissue. In an exemplary embodiment, the anchors 137 have one or more teeth that extend outwardly and into the patient's tissue when the implantable device 120 is injected or otherwise implanted within the patient's body. In other embodiments, the implantable device 120 may include other suitable anchors and / or anchoring may occur at a distal and / or intermediate section of the signal sending device 130. Other suitable anchors include, but are not limited to, (a) a bow spring that extends the longitudinal length of the electrode array and bends to provide a locking frictional force when the introducer sheath is retracted; (b) a thin wire mounted on a spring-loaded hinge that extends the longitudinal length of the electrode array and bends to provide a locking frictional force when the introducer sheath is retracted; (c) a cam that expands when rotated to provide a frictional locking action when a corresponding push rod is turned by the implanter; and / or (d) a torsion spring that expands when rotated to provide a frictional locking action when a corresponding push rod is turned by the implanter.

[0055] Other suitable anchoring techniques include bending or deforming the lead body 134 to urge it into contact with the walls of the channel formed by the insertion needle. The lead body may have a bend that is straightened during insertion (e.g., via a stylet or by being constrained within an introducer or cannula) but reforms to provide an anchoring force when the constraint is removed. In yet another technique, the distal end of the lead body 134 is bent (axially or columnarly) once at the target location. The bending action locally expands the diameter of the lead body and expands it against the tissue in which it is placed. For cases in which the device is temporarily implanted, the stylet used to introduce the device may have a bend or kink.

[0056] Yet another technique for securing the lead body and / or other implantable elements includes the use of a mesh. For example, a plug or mesh may be inserted over at least a portion of an already deployed lead body to improve anchoring. Thus, the plug or mesh is not integral with the lead body 134 when the lead body is implanted, but is instead added to secure the lead body after it is in place. The plug or mesh may be radially expanded like a suture sleeve that secures the lead body 134 to the adjacent tissue. The plug or mesh may be attached as a temporary anchor, or it may be the basis for a permanent anchor. Like the other elements described above, the plug or mesh may be delivered by implantation.

[0057] In at least some cases, the plugs or meshes described above can be utilized in acute as well as long-term or chronic applications (or in lieu of long-term or chronic applications). For example, if a bleeding event is induced by the attending physician or a subsequent infection occurs, the plug / mesh can be used to manage or minimize adverse sequelae, for example, by stopping the bleeding.

[0058] In operation, the receiving antenna 133 wirelessly receives power from a power source 109 carried by an associated wearable device 101 (FIG. 2). In at least some embodiments, the power received at the receiver antenna 133 is at a radio frequency, for example, in the range of about 400 MHz to about 2.5 GHz, for example, in the range of about 600 MHz to about 2.45 GHz, or in the range of about 900 MHz to about 1.2 GHz, or any other frequency or frequency range therebetween. At this frequency, the usable range of the wireless power transmission link 114 is about 10 cm, well beyond the distance sufficient to span the distance between the implantable signal transmission device 130 and the wearable device 101. In this range, the power transmission process is not expected to cause tissue heating, thus providing an advantage over other power transmission techniques, for example inductive power transmission techniques. However, in embodiments that provide reasonable control over the potential heating caused by inductive power transmission methods, inductive techniques can be used in place of the mid-field power transmission techniques described herein.

[0059] AC power received at the receiver antenna 133 is rectified to DC (e.g., via an AC-DC converter) and then transmitted to a DC-DC converter, charge pump and / or transformer 139 and converted to pulses in the range of about 10 Hz to about 500 Hz, e.g., about 30 Hz to about 300 Hz. In other embodiments, the pulses may be transmitted at a higher frequency (e.g., 10 kHz or higher) and / or in bursts. The amplitude of the signal may be about 1 mV to about 5 V (in certain embodiments, 1 V to 2 V) for a voltage controlled system, or about 1 mA to about 10 mA for a current controlled system. Circuitry 138 controls these signal transmission parameters and transmits the resulting electrical signal to the electrode 131 via a wire filament or other conductor 140 within the lead body 134. The circuitry thus forms (at least forms a part of) the signal generator 110 in that it receives the power transmitted wirelessly to the implantable device 120 and ultimately generates a signal that is transmitted to the patient. The resulting electric field generated when current is applied by the electrodes 131 produces the desired effect (e.g., excitation and / or inhibition) at the target nerve. In at least some embodiments, the implantable device 120 need not include any on-board power storage elements (e.g., power capacitors and / or batteries) to reduce system volume or need not include any power storage elements with a storage capacity of more than 0.5 seconds. In other embodiments, the implantable device 120 may include one or more miniature charge storage devices (e.g., capacitors, solid state batteries, and / or the like) that are compatible with the overall compact shape of the implantable device 120 and have a total charge storage capacity of 1 second or less, 30 seconds or less, 1 minute or less, 2 minutes or less, or 5 minutes or less, depending on the embodiment.

[0060] 6B is a partial schematic diagram of an implantable device 120 configured in accordance with another embodiment of the present technology. One feature of this embodiment is that the overall housing 135 (carrying the signal generator 110) and the lead body 134 are initially separate elements. Thus, the lead body 134 may be introduced into the patient's body, then positioned at or near the target neural population, and then coupled to the overall housing 135. One advantage of this approach is that the attending physician can choose between different lead bodies 134 having different lengths, i.e., choose the lead body 134 with the appropriate length (and / or other configuration attributes) for the treatment that a particular patient is undergoing. Another advantage is that the diameter of the tunnel that positions the (small diameter) lead body 134 in the inserted state can remain small enough to accommodate only the lead body 134, but not the (large diameter) overall housing 135. This approach can reduce trauma to the tissue, thereby allowing the patient to achieve the treatment endpoint. Other techniques may also be used to achieve the above results. For example, the tunnel (or at least some portion of the tunnel) into which the signal generator 110 and / or signal delivery device 130 are seated may be formed by tissue expansion rather than cutting. In addition to being less traumatic, this approach may create tissue compression around the signal generator 110 and / or signal delivery device 130, which may at least reduce the tendency of these elements to migrate.

[0061] The overall housing 135 may be positioned at or very close to the entrance opening to the patient's tissue. This approach has the added advantage that the overall housing 135, including the receiver antenna 133, is positioned close to the patient's skin, thereby reducing the power loss associated with transmitting power through the patient's skin to the signal transmission device 130. This approach may also reduce tissue heating, since power loss typically results in heat.

[0062] The lead body 134 may have multiple electrodes 131 positioned toward its distal end. For illustrative purposes, four electrodes 131 are shown in FIG. 6B, but in other embodiments, the signal sending device 130 may have a different number of electrodes 131. Each electrode 131 is coupled to a corresponding first terminal 129a via a corresponding conductor 140 (not visible in FIG. 6B). The lead body 134 may have an overall length L having any of a number of suitable predetermined / standard (or non-standard) values. The lead body 134 may have an axial lead opening 128a, for example, if the lead body 134 is delivered into the patient's body by a stylet. The stylet is then removed, and the lead body 134 is then coupled to the overall housing 135. In other embodiments, a stylet is not required, and instead the lead body 134 is housed within a lumen of a needle, introducer, or sheath and then deployed within the patient's body when the needle, introducer, or sheath is withdrawn from the patient.

[0063] The overall housing 135 includes an antenna housing 135a and a circuit housing 135b, which are at least generally similar to those described above with reference to FIG. 6A. The overall housing 135 may further include a connector housing 135c, which contains a second terminal 129b shaped and positioned to receive the first terminal 129a of the lead body 134. The connector housing 135c may be partially or entirely flexible. The second terminal 129b may be partially rigid and include a flexible component (e.g., a spring) that allows for resilient physical and electrical contact with the first terminal 129a. In a particular embodiment, the second terminal 129b may include a donut-shaped terminal positioned along the axial housing opening 128b. An exemplary second terminal is manufactured by Bal Seal Engineering, Inc. of Lake Forest, California. In operation, the attending physician introduces the lead body 134 into the patient's body separately from the overall housing 135, for example via a stylet. The lead body 134 is then coupled to the overall housing 135 by inserting the lead body 134 into the housing axial opening 128b as shown by arrow B. If the lead body 134 has previously been fixed in place, all or most of the insertion action is performed by the overall housing 135 rather than the lead body 134. The overall housing 135 may be fixed in place by one or more anchors 137 and / or sutures. In the event that either the lead body 134 or the overall housing 135 needs to be replaced, each may be replaced separately from the other by separating the lead body 134 from the overall housing 135.

[0064] In addition to being separable, portions of the lead body 134 and the overall housing 135 are flexible, so that each of these components can assume different orientations when inserted into the patient's tissue. For example, the lead body 134 can extend into the patient's tissue at a shallow or steep angle to access the target nerve. The overall housing can extend at an even shallower angle (e.g., parallel to the patient's skin surface) to position the antenna 133 for good (e.g., optimal) power reception. However, both elements can be introduced into the patient's body through the same opening, thus limiting the invasiveness of the implantation procedure. Additionally, the proximity of the overall housing 135 to the opening reduces the length of the sheath and / or other introducer required to position the overall housing 135 at its target location. In other embodiments, the lead body 134 can be delivered using both the distal and proximal openings, and the overall housing can be delivered only through the distal opening 195, as described above with reference to Figures 4A-4C.

[0065] Whether the implantable device 120 is implanted as a single unit or initially as two separate units, it may be useful to place different portions of the implantable device 120 into tunnels having different diameters (as discussed above). This approach may more securely secure the various elements of the implantable device 120 in place. For example, the implantation process may include inserting a small diameter (e.g., 0.014 inch (0.356 mm)) guidewire without further expansion to create a distal 5-30 mm tunnel. This portion of the tunnel may snugly receive the (small diameter) lead body 134. The portion of the tunnel that snugly receives the (large diameter) overall housing 135 may have a slightly larger diameter, e.g., 7 French (2.33 mm) to 8 French (2.66 mm). In the above example, the lead body 134 may have a diameter of 3 French (1 mm) and the overall housing 135 may have a diameter of 6 French (2 mm). In other embodiments, these diameters may be different (larger or smaller) and the tunnel diameter adjusted accordingly. This approach may eliminate the need for teeth or other minimally invasive anchors. As discussed above, the opening to receive the implantable device 120 may be primarily dilated / expanded to reduce tissue trauma and / or improve device anchorage.

[0066] In at least some embodiments, the electrical signal delivered to the patient may be delivered by a bipole formed by two of the electrodes 131. In other embodiments, the signal may be a unipolar signal, with the housing 135 (e.g., circuit housing portion 135b) forming a ground or return electrode. Typically, the waveform includes a biphasic, charge-balanced waveform, as described in more detail below with reference to Figures 7A and 7B.

[0067] FIG. 6C is a side view of another exemplary implantable device 220 including a leadless signaling device 230 configured in accordance with embodiments of the present technology. At least some aspects of the leadless signaling device 230 may be generally similar or identical in structure and / or function to the signaling device 130 of FIG. 6A and / or FIG. 6B. Thus, the same names and / or similar reference numbers (e.g., housing 135 of FIG. 6A versus housing 235 of FIG. 6C) are used to indicate generally similar or identical components. The leadless signaling device 230 includes a housing 235 having a first housing portion 235a, a second housing portion 235b, and a base 136. The first housing portion 235a may be generally similar to the antenna housing 135a and / or may have a first outer dimension D1 (e.g., a first width, a first diameter, a first circumference, and / or the like). The second housing portion 235b may be generally similar to the circuit housing 135b and / or may have a second outer dimension D2 (e.g., a second width, a second diameter, a second circumference). In the illustrated embodiment, the first outer dimension D1 is less than the second outer dimension D2. In other embodiments, the first outer dimension D1 may be greater than or equal to the second outer dimension D2. The base 136 may include one or more anchors 137.

[0068] The leadless signal transmission device 230 may further include an electrode receiver antenna 133, a signal generator 110, circuitry 138, a charge pump 139, and one or more electrodes 131. In the illustrated embodiment, the electrode receiver antenna 133 is positioned within the first housing portion 235a, the signal generator 110, circuitry 138, and charge pump 139 are positioned within the second housing portion 235b, and the electrodes 131 are carried by the second housing portion 235b. For example, as shown in FIG. 6C, the electrodes 131 are positioned to be exposed from an outer surface of the second housing portion 235b, such that each electrode 131 extends at least partially along a circumference of the second housing portion 235b. Thus, one or more of the electrodes 131 may extend at least partially or completely (e.g., circumferentially, axially, etc.) around one or more of the internal components of the leadless signal transmission device 230. In the illustrated embodiment, the signal generator 110, the circuitry 138, and the charge pump 139 are each positioned within the second housing portion 235b such that one or more of the electrodes 131 extend at least partially around each of the signal generator 110, the circuitry 138, and the charge pump 139. Specifically, in the illustrated embodiment, the electrodes 131 and / or the second housing portion 235b define an axial space or volume that accommodates each of the signal generator 110, the circuitry 138, and the charge pump 139. Additionally or alternatively, the electrode receiver antenna 133 may be positioned within the second housing portion 235b such that one or more of the electrodes 131 may extend at least partially around the electrode receiver antenna 133. In such an embodiment, the second housing portion 235b may be configured to reduce or prevent interference with reception of the power transmission link 114 by the electrode receiver antenna. The electrode 131 and / or second housing portion 235b are not expected to interfere with the operation of the electrode receiver antenna 133. Additionally or alternatively, one or more electrodes may be positioned on or at the first housing portion 235a so as to extend at least partially around the electrode receiver antenna 133.In these and other embodiments, one or more of the signal generator 110, the circuitry 138, and / or the charge pump 139 may be positioned within the first housing portion 235a and / or may be positioned differently outside and / or laterally relative to the space defined by the electrode 131 and / or the second housing portion 235b.

[0069] Each of the electrodes 131 may be coupled to the signal generator 110 by a respective conductor 140. In the illustrated embodiment, each of the conductors 140 is positioned within the second housing portion 235b, e.g., between the signal generator 110 and an inner surface of the second housing portion 235b. Additionally or alternatively, one or more feedthroughs 143 may couple the individual conductors 140 to the signal generator 110.

[0070] 6. Representative waveforms The signal generator and delivery device described above can generate and deliver any of a variety of suitable electrical stimulation waveforms to condition the patient's nerve and / or muscle activity. Representative embodiments are shown in Figures 7A and 7B, which include a series of biphasic stimulation pulses forming a stimulation wave cycle having a period as specified in Figures 7A and 7B. The waveform parameters may include an active cycle and a rest cycle. Each period P includes one or more pulses. The waveform shown in Figure 7A includes an anodic pulse, then an interphase delay, then a cathodic pulse, then an interpulse delay. Thus, the period P or cycle in general includes the following parameters: anodic pulse width (PW1), anodic amplitude (e.g., voltage or current amplitude VA), interphase delay / dead time, cathodic pulse width (PW2), cathodic amplitude (e.g., voltage or current amplitude VC), interpulse delay / idle time, and peak-to-peak amplitude (PP). The parameters may further include an indication of the identity of the electrodes to which the signal is directed. The anodic pulse width (PW1) in some embodiments is between 30 μs and 300 μs. The anodic amplitude (VA) in some embodiments is in the range of 1 mV to 5 V, or 1 mA to 10 mA. The inter-phase delay in some representative embodiments may be between 10 μs and 100 μs. The cathodic pulse width (PW1) in some representative embodiments is between 30 μs and 300 μs. In some representative embodiments, the anodic and cathodic phases are charge balanced, although the phases need not be symmetrical. The cathodic amplitude (VA) in some representative embodiments ranges from 0.3 V to 5 V. In some representative embodiments, the anodic and cathodic phases are charge balanced, although the phases need not be symmetrical. The inter-pulse delay in some representative embodiments may be between 10 μs and 250 μs. The peak-to-peak amplitude in some exemplary embodiments may be between about 2 mA and 12 mA. Exemplary frequencies are in the range of about 10 Hz to about 500 Hz in some embodiments, such as about 30 Hz to about 300 Hz, and in other embodiments up to 100 kHz (e.g., 10 kHz).These pulses may be delivered continuously or in bursts. The frequency, frequency range, amplitude (e.g., peak-to-peak amplitude), inter-pulse delay, pulse width, and / or other signal delivery parameters may vary based at least in part on the implantation location and / or stimulation target of the signal delivery device 130. In some embodiments, multiple signal delivery devices are implanted within the patient, with each signal delivery device configured to deliver a respective electrical signal having one or more respective signal delivery parameters. For example, a first signal delivery device implanted at a first location may be configured to deliver a first electrical signal having one or more first signal delivery parameters, and a second signal delivery device implanted at a second location may be configured to deliver a second electrical signal having one or more second delivery parameters, with each of the first signal delivery parameters (e.g., amplitude, frequency, etc.) being the same as and / or different from each of the second signal delivery parameters. Continuing with this embodiment, the first electrical signal may have a first frequency and / or a first amplitude, the second electrical signal may have a second frequency and / or a second amplitude, and the first frequency may be the same as or different from the second frequency, and / or the first amplitude may be the same as or different from the second amplitude.

[0071] FIG. 7B illustrates an exemplary waveform having an active portion and a rest portion. The active portion includes one or more periods having the characteristics described above with reference to FIG. 7A. The rest portion does not include a stimulation pulse. According to some exemplary embodiments, the ratio of active portions to rest portions may be between 1:1 and 1:9. As an exemplary example, if the ratio is 1:9 and there are 300 active periods, there are said to be 2700 rest portions.

[0072] In a representative embodiment, the stimulation voltage may be provided independently to each contact or electrode. For a positive pulse, the positive contact is pulled to the drive voltage and the negative contact is pulled to ground. For a negative pulse, the negative contact is pulled to the drive voltage and the positive contact is pulled to ground. For dead and idle times, both contacts are driven to ground. For quiescent times, both contacts are in a high impedance state. To prevent DC current from flowing through the contacts, each half bridge may be coupled to the contacts through a capacitor, for example a 100 μF capacitor. Additionally, a resistor may be placed in series with each capacitor to limit the current if the contacts are shorted. The pulses of the treatment waveform cycle may or may not be symmetrical, but are generally shaped to provide a net zero charge across the contacts.

[0073] 7. Alternative Implant Techniques 4A-4C and the associated discussion relate to a technique for implanting an electrode into a patient's skin using a curved needle with both entry and exit points. The following exemplary implantation technique is performed with a single puncture.

[0074] 7.1 Procedure 7.1.1 Materials Figure 8 outlines the overall procedure. Representative materials are listed below and in Figure 9. ·Basic surgical equipment (i.e. forceps, scalpels, etc.). Ultrasound system including color Doppler capability, 12L ultrasound probe, and ultrasound gel.

[0075] 7.1.2 Preparation for the procedure · Flush the dilator and / or sheath with sterile saline. - Pass the stimulation needle through the dilator. Pass the needle and dilator through the split sheath. Flush the needle with sterile saline.

[0076] 7.1.3 Patient Preparation The patient is placed in a supine position with the head supported by a foam ring and the surgeon positioned above the bed. The patient is instructed to rotate the head from side to side and comfortably extend the neck.

[0077] 7.1.4 Locating the hypoglossal nerve and identifying associated anatomical structures · The ultrasound probe is positioned approximately between the hyoid bone and the midpoint of the mandibular border and the hypoglossal nerve is identified on a sagittal view between the mylohyoid and hyoglossal muscles (Figure 10A, Figure 10B). While constantly maintaining an image of the HGN, rotate the probe to image a parasagittal view of the nerve with its longest length. Identify the anterior border of the hyoglossus muscle and the most distal part of the nerve before diving into the genioglossus muscle (Figure 11A, B). -Color Doppler ultrasound is used to identify vascular structures within the field. · Identify the submandibular and sublingual salivary glands with ultrasound imaging. Identify optimal submandibular and / or intraoral insertion sites that will position the delivery system and electrodes as close to parallel to the nerve as possible. o An external needle guide may be used to better align the needle insertion site with the ultrasound image. o Check to see if pushing or pulling on submandibular or intraoral tissue improves parallel alignment between the implant tool / lead path and the HGN. If such a feature is present, perform the necessary tissue manipulation with available tools. Mark the location of the probe by marking the end and center of the probe using a skin marker (Figure 12).

[0078] 7.1.5 Anesthetic Administration ·Administer conscious sedation, general anesthesia, and / or local anesthesia as ordered by a physician and with patient consent.

[0079] 7.1.6 Electrode Insertion Confirmation of target electrode position · Holding the dilator and sheath as proximally as possible (usually at the hub), insert the stimulation needle using ultrasound guidance to align the needle trajectory as close as possible to the HGN. The anterior edge of the hyoglossus muscle and the most distal part of the visible hypoglossal nerve can be used as the most proximal and most distal references for the needle trajectory. To make the angle as parallel as possible to the nerve, the needle can be inserted perpendicularly or at an exaggerated angle into the patient's skin / tissue, then angled to the desired angle, as described above with reference to FIG. 4A. More generally, stimulation prior to implantation of an implantable device is an important navigation method to identify the correct location to elicit a desired response and to locate the resident implant. Because the small diameter stimulation needle provides good ultrasound contrast, the needle can act as a "navigation waypoint" to create a path to follow when implanting the signal delivery device. Using this technique, multiple signal delivery devices can be delivered at either a single entry site or multiple entry sites. Multiple signal delivery devices can provide added assurance of identifying one or more treatment sites. When inserting the needle posterior to the nerve target field, the insertion point should be aligned with the midplane of the ultrasound probe and located 5-30 mm posterior to the posterior end of the ultrasound probe. If the needle is inserted anterior to the nerve target field, the insertion point should be aligned with the midplane of the ultrasound probe and be posterior to the medial border of the mandible. Observe the insertion technique and check for excessive blood flow. Connect the stimulating needle to the peripheral nerve stimulator, using a sterile cover if necessary. Electrical stimulation is applied using a stimulation needle. Typical parameters include a frequency in the range of 1 Hz to 50 Hz, e.g., a frequency of 40 Hz, a frequency in the range of 1 Hz to 3 Hz, or a frequency in the range of 1 Hz to 2 Hz, an amplitude of 0.25 to 5 volts, e.g., 1.5 volts, or 0.5 to 5 mA, and a pulse width of 25 to 250 μs, e.g., 150 μs. Slowly increase the amplitude of stimulation to ensure tongue protrusion (i.e., genioglossus activation) and minimal retrusion or dipping of the tongue downward within the mouth (styloglossus and hyoglossus activation). If no response or an undesirable response is observed, stimulation is stopped and the needle is adjusted slightly under ultrasound guidance. Once an appropriate stimulation response is obtained, the needle is disconnected from the peripheral nerve stimulator.

[0080] 7.1.7 Sheath Delivery · Holding the needle hub in place, the dilator is advanced over the stimulation needle under ultrasound guidance until the distal end of the dilator abuts the tip of the needle. The needle hub and dilator are held in place and the sheath is advanced under ultrasound guidance until the distal end of the sheath rests against the tip of the needle and dilator. Remove the needle and dilator, leaving the sheath in place.

[0081] 7.1.8 Implantable Electrode Array Placement An implantable electrode array (e.g., an implantable device 120, a signal transmission device 130, a linear array of electrodes carried by a lead body, etc.) is inserted into the sheath under ultrasound guidance until the implantable electrode array is visualized and protrudes from the end of the sheath. Remove the sheath while holding the electrode array in place. If possible, verify under ultrasound that the electrode array has not moved. Note: It may not be possible to visualize the hypoglossal nerve under the shadow cast by the electrode array. With an external anchor provided on the surface of the skin at the entry site, the implantable electrode lead body is secured with an external anchor provided on the surface of the skin at the entry site and / or an internal anchor carried by the implantable electrode lead body to allow for slack due to tongue reaction movement. Internal anchors may include modified leads or stylets, plugs, teeth, meshes, springs, suture ends, helices, etc., and may be used to provide improved stability. Connect a power source to the implantable electrode array, which may include aligning a transmitting antenna operatively coupled to the power source with an electrode receiver antenna operatively coupled to the implantable electrode array, for example by positioning the power source over / close to the implantable electrode array, using a sterile cover if necessary.

[0082] 7.1.9 Stimulation protocols · Using sterile technique, bag the power supply. Check that the power supply is set to minimum amplitude / frequency. Apply power to the implantable electrode array and begin stimulation. · Increasing the magnitude and / or frequency of the stimulation until a physiological response to the stimulation is observed. Check for physiological responses to the stimuli, including: ○Tongue protrusion (tongue protrusion) ○ Tongue retraction ○Dipping the tongue downwards in the mouth Flow measurements, e.g. airflow through a patient's airways Other observed physiological responses · Stop irritation. If necessary, repeat the stimulation protocol for other electrode configurations. If the desired response is not detected, the external or internal anchors should be loosened / retracted and the lead should be wiggled and resecured and retested. Set the final stimulus size. -Close the wound with sutures. - Recover the patient.

[0083] From the above, it will be appreciated that while specific embodiments of the technology have been described herein for illustrative purposes, various modifications may be made without departing from the technology. For example, the power source and associated wearable may have configurations other than an intraoral mouthpiece that also wirelessly delivers power to one or more implanted electrodes. Exemplary configurations include external skin-mounted devices and devices worn around the patient's neck, which may be suitable for targeting other nerves besides the cervical nerve trap, vagus nerve, and / or HGN. Other exemplary targets for stimulation include glossopalatine stimulation, cranial nerve stimulation, direct glossopalatine muscle stimulation, nasopharyngeal stimulation, and / or glossopharyngeal nerve stimulation. The anchors used to secure the signal transmission device in place may have configurations other than deployable teeth, including S-curve elements, helices, and / or porous structures that promote tissue ingrowth. Alternatively, the anchors may be eliminated or replaced with sutures, as described above. Signal transmission devices have been described above that include multiple housings forming an overall housing. In other embodiments, the multiple housings may be part of an overall unitary housing.

[0084] Certain aspects of the technology described in connection with a particular embodiment may be combined or omitted by other embodiments. For example, a signal emitting device having any of a variety of suitable configurations may be used with any one of the signal generators, and a signal generator having any of a variety of suitable configurations may be used with any one of the signal emitting devices. Furthermore, although advantages associated with a particular embodiment of the disclosed technology have been described in connection with this embodiment, other embodiments within the scope of the technology may also enjoy such advantages, and not necessarily all embodiments. Thus, the present disclosure and related technology may include other embodiments not explicitly shown and described herein.

[0085] As used herein, the phrase "and / or," such as "A" and / or "B," means A alone, B alone, and both A and B. To the extent that any material incorporated by reference conflicts with the present disclosure, the present disclosure controls.

[0086] To the extent that any material incorporated by reference conflicts with the present disclosure, the present disclosure controls.

[0087] The following embodiment section provides additional representative features of the present technology. Implementation Item [Embodiment 1] A method of treating a patient, comprising: implanting a signal delivery device percutaneously at a target signal delivery location within a patient, said signal delivery device having electrodes positioned to produce a net positive protrusive motor response of the patient's tongue; A method comprising the step of supplying power from a wearable power source to electrodes such that the electrodes deliver electrical signals to the target signal delivery location, thereby producing the net positive salient motor response. [Embodiment 2] The method described in embodiment 1, wherein the step of percutaneously implanting the signal sending device includes a step of percutaneously implanting the signal sending device in parallel with a medial branch of the patient's hypoglossal nerve, the signal sending device comprising an electrode, the electrode being positioned beneath the medial branch and beneath at least one retrouser extending from the medial branch. [Embodiment 3] The method of embodiment 2, wherein the step of percutaneously implanting the signal sending device includes a step of percutaneously implanting the signal sending device parallel to a medial branch of the patient's hypoglossal nerve, the medial branch having a retrofer extending away from the medial branch within a first region, and the signal sending device having an electrode positioned to send electrical stimulation to a second region opposite the first region. [Embodiment 4] The method according to any one of embodiments 1 to 3, wherein said net positive protrusion motor response comprises a withdrawal response and a protrusion response that is greater than said withdrawal response. [Embodiment 5] A method according to any one of embodiments 1 to 4, wherein the step of providing the power to the electrodes includes a step of causing the electrodes to transmit the electrical signal without activating any of the patient's retroviruses. [Embodiment 6] A method according to any one of embodiments 1 to 5, wherein the step of generating a net positive protrusive motor response of the patient's tongue includes at least one of a step of moving the patient's tongue anteriorly and away from the patient's airway, or a step of generating caudal traction of the patient's hyoid bone and / or thyroid cartilage. [Embodiment 7] A method according to any one of embodiments 1 to 6, wherein the target signal sending location includes the patient's hypoglossal nerve, cervical nerve trap, genioglossus muscle, geniohyoid muscle, sternohyoid muscle, thyrohyoid muscle, omohyoid muscle, and / or sternothyroid muscle. [Embodiment 8] A method according to any one of embodiments 1 to 7, wherein the step of generating a net positive protrusive motor response of the patient's tongue includes a step of causing the patient's airway to open or become further open in response to delivery of the electrical signal. [Embodiment 9] A method according to any one of embodiments 1 to 8, wherein the signal transmitting device is a first signal transmitting device, the target signal transmitting location is a first target signal transmitting location, and the method further comprises the step of percutaneously implanting a second target signal transmitting device near the second target signal transmitting location. [Embodiment 10] The method of any one of embodiments 1 to 9, wherein the step of providing power includes transmitting power to the electrode via an RF link. Embodiment 11. The method of embodiment 10, wherein said step of transmitting said power via said RF link comprises the step of transmitting said power at a frequency within a frequency range of 400 MHz to 2.5 GHz. Embodiment 12. The method of embodiment 10 or 11, wherein said step of transmitting said power comprises the step of transmitting said power at a frequency within the frequency range of 900 MHz to 1.2 GHz. [Embodiment 13] The step of providing said power to said electrodes comprises the steps of: Interpulse delay from 10μs to 250μs, 0.5mA to 12mA peak-to-peak amplitude, or Frequencies in the frequency range from 10Hz to 500Hz The method according to any one of the first to second embodiments, further comprising the step of transmitting an electrical signal having at least one of the following: [Embodiment 14] A method according to any one of embodiments 1 to 13, wherein the electrode has a plurality of circumferential segments, and the step of providing the power to the electrode includes a step of the electrode transmitting the electrical signal via each of the circumferential segments of the electrode. Prior to implanting the signal sending device, a needle is percutaneously inserted into the patient's body along a trajectory toward the medial branch of the patient's hypoglossal nerve; The method of any one of embodiments 1 to 14, further comprising the step of aligning the needle with the medial branch, and wherein the step of implanting the signal sending device comprises the step of orienting the signal sending device along the trajectory of the needle. [Embodiment 16] The method of embodiment 15, wherein the electrical signal is a first electrical signal, and the method further comprises the step of transmitting a second electrical signal to the patient via the needle to assist in positioning the signal transmitting device. [Embodiment 17] The method described in embodiment 16, wherein the first electrical signal has the first signal transmission parameter and the second electrical signal has a second signal transmission parameter different from the first signal transmission parameter. [Embodiment 18] A method according to any one of embodiments 1 to 17, wherein the step of percutaneously implanting the signal sending device includes a step of directing a percutaneous insertion tool into the patient's body at a first location. [Embodiment 19] The method of embodiment 18, wherein the step of directing the percutaneous insertion device into the patient's body to the first location includes the step of directing the percutaneous insertion device into the patient's body to a submandibular location. [Embodiment 20] The method of embodiment 18, wherein the step of directing the percutaneous insertion device into the patient's body to the first location includes the step of directing the percutaneous insertion device into the patient's body to an intra-oral location. [Embodiment 21] The method of embodiment 20, wherein the step of directing the percutaneous insertion device into the patient's body to the intraoral location includes the step of directing the percutaneous insertion device into the patient's body to a sublingual location. [Embodiment 22] A method according to any one of embodiments 18 to 21, wherein the step of percutaneously implanting the signal sending device further includes the step of directing the percutaneous insertion tool from within the patient's body to a second location. [Embodiment 23] The method of embodiment 22, wherein the step of directing the percutaneous insertion device from within the patient's body to the second location includes the step of directing the percutaneous insertion device from within the patient's body to an intra-oral location. [Embodiment 24] The method of embodiment 22, wherein the step of directing the percutaneous insertion device from within the patient's body to the second location includes the step of directing the percutaneous insertion device from within the patient's body to a submandibular location. [Embodiment 25] A method according to any one of embodiments 1 to 24, wherein the target signal emission location includes the patient's hypoglossal nerve, the medial branch of the hypoglossal nerve, the cervical trapezius, the genioglossus muscle, and / or the geniohyoid muscle. 26. A method for treating a vascular endovascular disease comprising the steps of: attaching a first suture to a first end of the signal sending device; and coupling the second suture to a second end of the signal delivery device. The method of any one of embodiments 1 to 25, wherein the step of percutaneously implanting the signal transmission device further includes the step of selectively pulling at least one of the first suture or the second suture to position the signal transmission device at the target signal transmission location. Embodiment 27. A method of treating a patient, comprising: implanting a signal delivery device percutaneously in tandem with a medial branch of the hypoglossal nerve in said patient; the signal receiving device has an electrode positioned beneath the inner branch and beneath a retrograde extending from the inner branch; and / or the retro-transducer extends away from the medial branch at a first region and the electrode is positioned to deliver an electrical signal to a second region opposite the first region; providing power from a wearable power source to the electrodes to treat a sleep disorder in the patient. [Embodiment 28] The method of embodiment 27, wherein said step of providing said power comprises the step of transmitting said power to said electrode via an RF link. Embodiment 29. The method of embodiment 28, wherein said step of transmitting said power via said RF link includes the step of transmitting said power at a frequency within the frequency range of 400 MHz to 2.5 GHz. Embodiment 30. The method of embodiment 29, wherein said step of transmitting said power includes the step of transmitting said power at a frequency within the frequency range of 900 MHz to 1.2 GHz. [Embodiment 31] The step of providing said power to said electrodes comprises the steps of: Interpulse delay from 10μs to 250μs, 0.5mA to 12mA peak-to-peak amplitude, or Frequencies in the frequency range from 10Hz to 500Hz The method according to any one of embodiments 27 to 30, comprising the step of transmitting an electrical signal having at least one of the following: [Embodiment 32] The method of embodiment 31, wherein the step of providing said power to said electrodes includes a step of causing said electrodes to transmit electrical signals to the patient without activating said retro-detector. Prior to implanting the signal sending device, a needle is percutaneously inserted into the patient along a trajectory toward the medial branch of the patient's hypoglossal nerve; The method of any one of embodiments 27 to 32, further comprising the step of aligning the needle with the medial branch, and wherein the step of implanting the signal sending device comprises the step of orienting the signal sending device along the trajectory of the needle. 34. The method of claim 33, further comprising the step of transmitting said electrical signal via said needle to said patient to assist in positioning said signal transmitting device. [Embodiment 35] A method according to any one of embodiments 27 to 34, characterized in that the step of percutaneously implanting the signal sending device includes a step of percutaneously injecting the signal sending device into the patient's body at a submandibular location, a location in the oral cavity, or a sublingual location. [Embodiment 36] A method according to any one of embodiments 27 to 35, characterized in that the signal sending device is a first signal sending device, and the method further comprises the step of percutaneously implanting a second signal sending device near the target location. [Embodiment 37] The method of embodiment 36, wherein the target location includes another hypoglossal nerve of the patient, a medial branch of the hypoglossal nerve, a cervical nerve trap of the patient, a genioglossus muscle of the patient, and / or a geniohyoid muscle of the patient. [Embodiment 38] The method of embodiment 36 or 37, wherein the medial branch of the patient's hypoglossal nerve is the medial branch of the patient's left hypoglossal nerve, and the step of percutaneously implanting the second signal sending device near the target location includes the step of percutaneously implanting the second signal sending device near the medial branch of the patient's right hypoglossal nerve. [Embodiment 39] A method according to any one of embodiments 27 to 38, wherein the step of providing power to treat the sleep disorder includes the step of producing a tongue motor response in the patient. [Embodiment 40] The method of embodiment 39, wherein the step of generating a motor response of the patient's tongue includes at least one of the steps of moving the patient's tongue anteriorly and away from the patient's airway, or generating caudal traction of the patient's hyoid bone and / or thyroid cartilage. [Embodiment 41] A signal sending device, comprising: Housing and an antenna positioned within the housing and configured to receive a wireless power signal via the wearable power source; a signal generator positioned within the housing and operably coupled to the antenna; an electrode carried by the housing and operably coupled to the signal generator, the electrode extending at least partially around at least one of (1) at least a portion of the signal generator, or (2) at least a portion of the antenna. [Embodiment 42] The signal sending device of embodiment 41, wherein the housing includes a first housing portion and a second housing portion, the electrode is positioned at an outer surface of the first housing portion, the signal generator is positioned within the first housing portion, and the antenna is positioned within the second housing portion. [Embodiment 43] A signal sending device as described in embodiment 41 or 42, wherein the signal generator comprises a circuit section and / or a charge pump, and the electrodes extend at least partially around the circuit section and / or the charge pump. [Embodiment 44] A signal sending device described in any one of embodiments 41 to 43, wherein the electrode is configured to be positioned below the medial branch of the patient's hypoglossal nerve and below at least one retroluzer extending from the medial branch. 45. The signal generator is configured so that the electrodes emit electrical signals, the electrical signals being: Interpulse delay from 10μs to 250μs, 0.5mA to 12mA peak-to-peak amplitude, or Frequencies in the frequency range from 10Hz to 500Hz 45. The signal sending device according to any one of embodiment items 41 to 44, having signal sending parameters including: [Embodiment 46] A signal sending device according to any one of embodiments 41 to 45, wherein the electrodes are configured to apply an electrical signal to a target location of the patient without stimulating any of the patient's retrogrades. [Embodiment 47] A signal transmitting device according to any one of embodiments 41 to 46, wherein one of the electrodes is masked in the circumferential direction or segmented in the circumferential direction. 48. A system for delivering an electrical signal to a patient, said system comprising: a percutaneously deliverable lead body having a plurality of electrodes, each electrode connected to a corresponding first terminal carried by the lead body; a separate percutaneously deliverable housing having a second terminal positioned to mate with the first terminal during an implantation procedure, the housing having a pulse generator coupled to the second terminal, and a receiving antenna coupled to the pulse generator. [Embodiment 49] The system of embodiment 48, characterized in that the percutaneously deliverable lead body is configured such that at least one of the plurality of electrodes is positioned beneath the medial branch of the patient's hypoglossal nerve and beneath at least one retractor extending from the medial branch. [Embodiment 50] The pulse generator is configured such that one or more of the plurality of electrodes deliver an electrical signal to the inner branch, the first electrical signal being: Interpulse delay from 10μs to 250μs, 0.5mA to 12mA peak-to-peak amplitude, or Frequencies in the frequency range from 10Hz to 500Hz 50. The system of embodiment 48 or 49, having signal transmission parameters including: 51. The percutaneously deliverable lead body and the percutaneously deliverable housing include a first implantable device, the system comprising: a second implantable device configured to be positioned proximate the patient's target stimulation location and to deliver a second electrical signal to the target stimulation location; The system of any one of embodiments 48 to 50, wherein the target stimulation location includes another medial branch of another hypoglossal nerve of the patient, the cervical nerve trap of the patient, the genioglossus muscle of the patient, and / or the geniohyoid muscle of the patient. [Embodiment 52] The system described in embodiment 51, characterized in that the first signal sending device is configured to send a first electrical signal having one or more first signal sending parameters, and the second signal sending device is configured to send a second electrical signal having one or more second signal sending parameters. [Embodiment 53] The system described in embodiment 52, characterized in that at least one of the one or more first signal transmission parameters has a value different from a corresponding one of the one or more second signal transmission parameters. [Embodiment 54] The system described in embodiment 52 or 53, characterized in that the one or more first signal transmission parameters include a first amplitude and the one or more second signal transmission parameters include a second amplitude, the second amplitude being different from the first amplitude. [Embodiment 55] A system described in any one of embodiments 48 to 54, characterized in that at least one of the plurality of electrodes is configured to apply an electrical signal to a target location of the patient without stimulating at least one probe of the patient. [Embodiment 56] The system of embodiment 55, wherein at least one of the electrodes is circumferentially masked or circumferentially segmented. [Embodiment 57] The housing includes a connector housing having an axial lead body opening configured to releasably receive the second terminal and the first terminal of the lead body in an axially extending manner; the first terminal is positioned on an outer surface of the lead body and configured for positioning through the axial lead body opening into a corresponding one of the second terminals; the lead body has a first outer diameter; the housing has a second outer diameter greater than the first outer diameter; The system according to any one of embodiments 48 to 56, wherein the receiving antenna is configured to receive an RF signal from a wearable power source. Embodiment 58. A method of treating a patient comprising: inserting a needle percutaneously into the patient along a trajectory toward a medial branch of the patient's hypoglossal nerve; aligning the needle with the inner branch; implanting a signal delivery device percutaneously in parallel with the medial branch via the track defined by the needle, the signal delivery device having electrodes positioned to produce a net positive protrusive motor response of the patient's tongue; the electrode is positioned beneath the inner branch and beneath a retro-transducer extending from the inner branch; and / or the retro-transducer extends away from the medial branch within a first region, and the electrode is positioned to deliver electrical stimulation to a second region opposite the first region; providing power from a wearable power source to the electrodes to treat a sleep disorder in the patient, the step of percutaneously inserting the needle includes directing the needle into the patient's body at a subgingival location or an intraoral location and delivering a first electrical signal to the patient via the needle; The step of providing power includes the steps of transmitting power to the electrode via an RF link and Interpulse delay from 10μs to 250μs, 0.5mA to 12mA peak-to-peak amplitude, or A first frequency within a first frequency range from 10 Hz to 500 Hz and transmitting a second electrical signal having at least one of: The method, wherein sending the power over the RF link includes sending the power at a second frequency within a second frequency range of 400 MHz to 2.5 GHz. [Embodiment 59] The method of embodiment 58, wherein the signal sending device is a first signal sending device, and the method further comprises the step of percutaneously implanting a second signal sending device near the target stimulation location. [Embodiment 60] The method of embodiment 59, wherein the target stimulation locations include another hypoglossal nerve of the patient, the cervical nerve trap of the patient, the genioglossus muscle of the patient, and / or the geniohyoid muscle of the patient. [Embodiment 61] The method described in embodiment 59 or 60, wherein the medial branch of the patient's hypoglossal nerve is the medial branch of the patient's left hypoglossal nerve, and the step of percutaneously implanting the second signal sending device near the target stimulation location includes a step of percutaneously implanting the second signal sending device near the medial branch of the patient's right hypoglossal nerve. [Embodiment 62] The method of any one of embodiments 58 to 61, wherein said net positive protruding motor response comprises a withdrawal response and a protruding response that is greater than said withdrawal response. [Embodiment 63] A method according to any one of embodiments 58 to 62, wherein the step of providing the power to the electrodes includes a step of causing the electrodes to transmit the electrical signal without activating any of the patient's retro-transducers. [Embodiment 64] A method according to any one of embodiments 58 to 63, wherein the step of generating a net positive protrusive motor response of the patient's tongue includes at least one of the steps of moving the patient's tongue anteriorly and away from the patient's airway, or generating caudal traction of the patient's hyoid bone and / or thyroid cartilage. [Embodiment 65] A method according to any one of embodiments 58 to 64, wherein the step of generating a net positive protrusive motor response of the patient's tongue includes a step of causing the patient's airway to open or become further open in response to delivery of the electrical signal.

Claims

**Claim 1** A system for addressing a patient's sleep apnea, comprising an implantable device, and a programmer communicatively coupled to the implantable device, wherein the implantable device comprises a housing configured to be injectable percutaneously, a signal generator positioned within the housing and configured to generate one or more electrical signals, and a signal delivery device operably coupled to the signal generator, the signal delivery device being configured to be positioned at or near a motor endplate of the patient where the patient's hypoglossal nerve supports the patient's genioglossus muscle, and further configured to direct the one or more electrical signals toward the motor endplate to address the patient's sleep apnea, the programmer comprises one or more processors, and one or more non-transitory computer-readable media having instructions that, when executed by the one or more processors, cause the signal delivery device to direct the one or more electrical signals toward the motor endplate. **Claim 2** The system of claim 1, wherein the housing comprises an outer surface, and the signal delivery device comprises a plurality of electrodes carried by the outer surface of the housing. **Claim 3** The system of claim 1, wherein the signal delivery device comprises a lead coupled to the housing, extending from the housing, and carrying a plurality of electrodes. **Claim 4** The housing and the signal delivery device are configured to be separately implantable, the signal delivery device comprises one or more first terminals, and the housing comprises one or more second terminals configured to be operably connected to the one or more first terminals to operably couple the signal delivery device to the signal generator. **Claim 5** The implantable device comprises a power receiving device, and the system further comprises a power transmission device positioned to wirelessly transmit power to the signal delivery device via the power receiving device. **Claim 6** The system of claim 5, wherein the power receiving device comprises a first frequency antenna, and the power transmission device comprises a second frequency antenna. **Claim 7** The power receiving device includes a first induction coil, and the power transmission device includes a second induction coil. The system according to claim 5.

8. The signal sending device is implanted in or near the motor endplate. The system according to claim 1.

9. The one or more electrical signals include one or more frequencies within a frequency range from 10 Hz to 500 Hz. The system according to claim 1.

10. The one or more electrical signals include one or more amplitudes within an amplitude range of 0.5 mA to 12 mA. The system according to claim 1.

11. Furthermore, it has an implant tool configured to facilitate placement of the signal sending device at or near the position of the motor endplate. The implant tool is an introducer configured to form a percutaneous insertion path, through which the receiving-type instrument can be injected along the percutaneous insertion path to the position of the motor endplate or a position close to the motor endplate. is a needle including an electrically operable tip, configured to be received within the introducer, and configured to direct the one or more electrical navigation signals towards the surrounding tissue so that a user can observe the patient's motor response to the one or more electrical navigation signals before injecting the implant-type instrument. The system according to claim 1.

12. The introducer and the needle are configured to move forward together towards the motor endplate while the needle is positioned through the introducer and the electrically operable tip directs the one or more electrical navigation signals towards the surrounding patient tissue. When the user determines, based on the patient's motor response, that the electrically operable tip is positioned at or near the position of the motor endplate, the needle is configured to be removed from the introducer, the implant-type instrument is injected through the introducer, and the signal sending device is positioned at or near the position of the motor endplate. The system according to claim 11.

13. The one or more electrical navigation signals include one or more frequencies within a frequency range from 1 Hz to 3 Hz. The system according to claim 11.

14. The system of claim 11, wherein the one or more electrical navigation signals include one or more amplitudes in an amplitude range of 0.5 mA to 12 mA.

15. The system of claim 11, wherein the needle is configured to form an opening that penetrates the patient's skin under the patient's jaw.

16. The system of claim 1, wherein the implantable device further includes an anchor coupled to the signal transmitter and configured to be disposed to fix the implantable device at a fixed position of the motor endplate.

17. Furthermore, having a wearable device configured to be worn around the patient's neck, the wearable device includes one or more sensors including a heart rate sensor, a voice sensor, a head orientation and / or position sensor, and / or a blood oxygen sensor; and a communication device configured to transmit data obtained via the one or more sensors to the programmer, wherein the programmer is configured such that, at least in part based on the data, the signal transmitter directs the one or more electrical signals to the motor endplate. The system of claim 1.

18. The system of claim 1, wherein the signal transmitter is configured to be at least partially implanted within the patient's genioglossus muscle.

19. The implantable device is a first implantable device, the system further having a second implantable device positionable in or proximate to the patient's cervical nerve sheath for supplying one or more second electrical signals to the patient's cervical nerve sheath. The system of claim 1.

20. The system of claim 19, wherein the first implantable device is implanted in the patient near or at the position of the motor endplate, and the second implantable device is implanted in the patient near or at the position of the cervical nerve sheath.

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