Remotely powered implantable electrode, related system, and method for treating sleep apnea

Abstract

This invention provides an implantable electrode with a power delivery wearable for treating sleep apnea, as well as related systems and methods. [Solution] A typical system includes a non-implantable signal generator wearable by the patient, which has an antenna that directs a midfield RF signal to an implantable electrode. The implantable electrode then directs a low-frequency signal to a nerve target, such as the patient's hypoglossal nerve. The typical signal generator may be in the form of a mouthpiece, collar, or other wearable and / or skin-attached patch.

Description

Technical Field

[0001] This technology generally relates to implantable electrodes wirelessly coupled to a remote power delivery device for treating sleep apnea, as well as related systems and methods. Representative power delivery devices include mouthpieces, devices worn in the form of collars or other neckwear, and / or adhesive skin attachment devices.

[0002]

Cross - Reference to Related Applications

Background Art

[0003] Obstructive sleep apnea (OSA) is a condition in which the patient's upper airway repeatedly becomes obstructed (partially or completely) during sleep, causing arousal. Repeated obstruction of the upper airway can cause fragmentation of sleep, resulting in sleep deprivation, daytime fatigue, and / or drowsiness. In more severe cases of OSA, patients may be at increased risk of stroke, cardiac arrhythmia, hypertension, and / or other disorders.

[0004] OSA is characterized by the tendency of the soft tissues of the upper airway to collapse or prolapse during sleep, thereby obstructing the upper airway. OSA is typically caused by prolapse of the soft palate, oropharynx, tongue, epiglottis, or a combination thereof into the patient's upper airway, thereby interfering with normal breathing and / or causing arousal from the sleep state.

Summary of the Invention

Problems to be Solved by the Invention

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

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

[0007] According to one aspect of the present invention, a patient treatment system, This includes wearable devices, and wearable devices are, Power storage device, A power transmission antenna, which is coupled to a power storage device and configured to emit RF signals in a frequency range from 300 MHz to 6 GHz, It has a first control circuit unit coupled between the power storage device and the power transmission antenna, This includes implantable devices, and the implantable devices are, Electrodes and, A housing supporting electrodes, The housing supports the implantable device, and the anchor is positioned to secure the implantable device to the tissues in the patient's oral cavity. An electrode receiver antenna configured to receive RF signals in the frequency range from 300 MHz to 6 GHz, An electrode receiver antenna and a signal generator coupled to the electrode direct the signal to the electrode at a frequency range of 10 Hz to 300 Hz, A patient treatment system is provided, characterized by having a signal generator and a second circuit unit coupled between the electrodes to control the transmission of signals to the electrodes.

[0008] According to another aspect of the present invention, a sleep apnea treatment system, This includes oral instruments designed to fit inside the patient's mouth, and the oral instruments are, A lower mouthpiece portion supporting a transmitting antenna configured to emit an RF signal at a first frequency, and It has an upper mouthpiece section located on the opposite side of the lower mouthpiece section, and the upper mouthpiece section is A power storage device operably coupled to a power transmission antenna, and It carries a first control circuit unit that is operably coupled to a power storage device and a power transmission antenna, It has a connector that joins the lower mouthpiece part and the upper mouthpiece part. This includes implantable devices, and the implantable devices are, Electrodes and, An electrode receiver antenna configured to receive RF signals emitted by a power transmitting antenna, A signal generator coupled to an electrode receiver antenna and an electrode, capable of directing a stimulus signal to the electrode at a second frequency, and A sleep apnea treatment system is provided, characterized by having a second circuit unit coupled between a signal generator and an electrode to control the transmission of a stimulus signal to the electrode.

[0009] According to yet another aspect of the present invention, a method for directing an electrical signal to an individual, The process includes the step of transmitting a first electrical signal via a power transmitting antenna of a wearable device which is programmed to establish a wireless communication relationship with a receiver antenna of an implanted device, wherein at least a portion of the first electrical signal has a first frequency in a first frequency range from about 300 MHz to about 6 GHz. Program the pulse generator for the implantable device, A first electrical signal is received via the electrode receiver antenna, and A method is provided which includes the step of transmitting a second electrical signal via at least one electrode of an implantable device positioned to electrically communicate with a target nerve of an individual, wherein at least a portion of the second electrical signal has a second frequency in a second frequency range up to 100 kHz.

[0010] According to yet another aspect of the present invention, a method for treating a patient, The steps include: percutaneously implanting an implantable device near the medial branch of the hypoglossal nerve in the patient, and positioning the electrode supported by the implantable device so as to establish an electrical connection with the medial branch of the hypoglossal nerve in the patient; The steps include transmitting a first signal from the power transmitting antenna of a wearable device to the receiving antenna of an implanted device, A step of converting a first signal to a second signal using a signal generator in an implantable device, A method is provided which includes the step of applying a second signal to the medial branch of the hypoglossal nerve of a patient via an electrode.

[0011] Representative embodiments of this technology are shown as examples, and these are not limited by the figures. In the figures, the same reference numerals indicate corresponding parts throughout the entire figure. [Brief explanation of the drawing]

[0012] [Figure 1] This is a lateral cross-sectional view showing the patient's upper airway. [Figure 2A]It is a view of the patient's skull from below, showing the hypoglossal nerve and representative electrode placement locations according to an embodiment of the present invention. [Figure 2B] It is a side view of the patient's skull, showing another representative signal transmission target according to an embodiment of the present technology. [Figure 3A] It is a block diagram showing the components of a system for treating sleep disorders according to an embodiment of the present technology. [Figure 3B] It is a partial schematic side cross-sectional view of the patient's upper airway and the components of a system for treating sleep disorders according to an embodiment of the present technology. [Figure 4] It is a partial schematic view of a signal transmission device configured according to an embodiment of the present technology. [Figure 5A] It is a partial schematic view of an upper mouthpiece portion, a lower mouthpiece portion, and a signal generator having a circuit and power supply positioned on the inner surface of the lower mouthpiece portion. [Figure 5B] It is a partial schematic view of an upper mouthpiece portion, a lower mouthpiece portion, and a signal generator having a circuit and power supply positioned on the inner surface of the upper mouthpiece portion. [Figure 5C] It is a partial schematic view of an upper mouthpiece portion, a lower mouthpiece portion, and a signal generator having a circuit and power supply positioned on the outer surface of the upper mouthpiece portion and / or the lower mouthpiece portion. [Figure 6] It is a partial schematic isometric view of a signal transmission device having an upper mouthpiece portion with a loop portion carrying a circuit section, a power supply, one or more sensors, and / or a data receiver antenna according to a representative embodiment of the present technology. [Figure 7] It is a partial schematic view of a number of device configurations for controlling individual electrodes with a control circuit according to an embodiment of the present invention. [Figure 8A] It is a view showing a representative example of a waveform having selected waveform parameters according to an embodiment of the present technology. [Figure 8B] It is a view showing a representative example of a waveform having an active period and a rest period according to an embodiment of the present technology.

Embodiments for Carrying Out the Invention

[0013] This technology will be explained under the following headings for easier reading. · Headline 1 :"introduction" · Heading 2 : "Typical Stimulus Targets" (Focusing on Figures 1-2B) · Heading 3 : "Typical apparatus and methods" (focusing on Figures 3A to 7) · Heading 4 : "Typical waveforms" (focusing on Figures 8A and 8B)

[0014] While embodiments of this technology are described under the selected headings above, other embodiments of this technology may include components described under numerous headings. Therefore, the fact that an embodiment can be described under a specific heading does not necessarily mean that the embodiment is limited to the components described under that heading.

[0015] 1. Introduction Electrical stimulation for obstructive sleep apnea (OSA) typically involves applying an electric current that modulates nerves and / or muscles to cause movement of the tongue and / or other soft tissues. Therefore, electrical stimulation can relieve upper airway obstruction and prevent the tongue or other soft tissues from collapsing or obstructing the airway. As used herein, the terms “modulation” and “stimulation” are used interchangeably to mean an effect on one or more motor functions, e.g., respiratory motor functions, e.g., an effect on nerves that exert an influence on such motor functions.

[0016] Representative methods and apparatus for reducing the incidence and / or severity of respiratory disorders, such as OSA, are disclosed herein. According to a representative embodiment, a minimally invasive signaling device is implanted near or adjacent to nerves innervating the patient's oral cavity, soft palate, oropharynx, and / or epiglottis. Representative nerves include the hypoglossal nerve, branches of the cervical ligament, and / or vagus nerve, which are adjacent to and / or around the oral cavity or located within the neck. The signaling device is preferably implanted in the patient's body by percutaneous injection. For example, a non-implantable power source including 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-attached devices may wirelessly supply power to the implanted signaling device. The signaling device emits precisely targeted electrical signals (e.g., pulses) which improve the patient's upper airway patency and / or improve the tension of the oral cavity tissues in order to treat sleep apnea. The electric current transmitted by the signaling device can stimulate efferent peripheral nerves, such as the hypoglossal nerve and / or other nerves of the patient associated with the upper airway. By moving the tongue forward and / or preventing the tongue and / or soft tissues from collapsing over the back of the patient's pharynx and / or over the upper airway, the devices and related methods disclosed herein can improve the quality of a patient's sleep, for example, by moving potentially obstructive tissues in the upper airway / pharynx downward. Specifically, by applying an electrical signal to the medial branch of the hypoglossal nerve, the tongue can be moved forward, and by applying an electrical signal to the cervical nerve loop, the thyroid gland, larynx, trachea, and / or any of these tissues (e.g., cartilage) can be moved downward (inferior or caudal), such movement is commonly referred to as caudal traction. The system may further include one or more feedback and / or diagnostic devices or functions that control the presence, timing, and / or manner in which electrotherapy is delivered to the patient.Therefore, one or more sensors can detect patient characteristics (e.g., sleep state, wake state, and / or respiratory characteristics), and such patient characteristics can be used to measure treatment or therapy in real time or near real time. As a result, the system can treat nerve targets only when the patient is asleep and / or when the patient's respiratory performance (e.g., oxygen perfusion level) indicates that treatment is necessary or beneficial.

[0017] Many embodiments of the technology described below may take the form of computer-executable, machine-executable, or controller-executable instructions, including routines executed by a programmable computer or controller. As those skilled in the art will understand, the technology can be implemented on computer / controller systems other than those illustrated and described below. The technology can be embodied in a special-purpose computer, controller, or data processor that is specifically programmed, configured, or set up to execute one or more of the computer-executable instructions described below. Thus, as used herein, “computer” and “controller” mean any appropriate data processor, and these terms may include Internet applications and handheld devices (such as palmtop computers, wearable computers, tablets, mobile phones, mobile phones, multiprocessor systems, processor-based consumer electronics, programmable consumer electronics, network computers, and minicomputers). Information handled by these computers can be presented on any appropriate display medium, such as a liquid crystal display (LCD).

[0018] This technology can also be implemented in a distributed environment, in which tasks or modules are executed by remote processing units linked to each other via a communication network. In a distributed computing environment, program modules or subroutines can be implemented in local or remote storage devices. The aspects of the technology described below can be stored on or distributed on any suitable computer-readable medium including one or more ASICs (e.g., with addressable memory), or distributed electronically via a network. Data structures and data transmission specific to the aspects of this technology are also included in the scope of embodiments of this technology.

[0019] 2. Typical Stimulation Targets Representative embodiments described herein include a signaling device having electrodes that are preferably positioned to deliver one or more currents to one or more specific target locations, e.g., specific nerves and / or specific locations along nerves. Figure 1 shows the general anatomical structure of a patient's oral cavity, and subsequent figures show specific target locations. Such locations include locations along the patient's hypoglossal nerve, branches of the cervical septum, and / or vagus nerve, such as nerves innervating the muscles of the airway other than the tongue (e.g., palatine muscles, oropharyngeal muscles, laryngeal muscles). Target locations can be specified for any of intrinsic muscles, extrinsic muscles, associated nerve branches, and / or other physiological features, or any combination thereof. Such target locations and / or locations are also preferably located far from salivary glands (e.g., located inside the sublingual salivary glands) and / or other structures in order to avoid producing pain and / or other undesirable effects.

[0020] Figure 1 shows patient P in a coordinate system where the x-axis represents the anterior-posterior direction, the y-axis represents the upward-downward direction, and the z-axis represents the medial-lateral direction. Patient P has a hard palate HP located above the tongue T, forming the roof of the oral cavity (e.g., mouth). The hard palate HP has a bony support BS and thus does not normally deform during respiration. The soft palate SP, made of soft tissue such as membrane, fibrous tissue, adipose tissue, and muscle tissue, extends posteriorly (e.g., posteriorly) from the hard palate HP towards the back of the pharyngeal pharyngeal hemisphere. More specifically, the anterior end AE of the soft palate SP is fixed to the posterior end of the hard palate HP, while the posterior end PE of the soft palate SP is unfixed. Since the soft palate SP does not contain bone or hard cartilage, it can bend and may collapse into the back of the pharyngeal pharyngeal hemisphere and / or flap back and forth (e.g., especially during sleep).

[0021] The pharyngeal pharyngeal rhinopharynx (PHR) is the part of the throat that delivers air from the oral cavity (OC) and nasal cavity (NC) to the trachea (TR), located below the nasal cavity, behind the oral cavity (OC), and above the esophagus (ES). The pharyngeal PHR is separated from the oral cavity (OC) by the palatolaryngeal arch (PGA), which extends downward on both sides toward the base of the tongue (T). Although not illustrated for simplification, the pharyngeal PHR includes the nasopharynx, oropharynx, and pharyngolarynx. The nasopharynx is located between the upper surface of the soft palate (SP) and the throat wall (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 to the oral cavity (OC). The transverse wall of the oropharynx consists of the palatine tonsils and is located between the palatolaryngeal arch (PGA) and the palatopharyngeal arch. The anterior wall of the oropharynx consists of the base of the tongue (T) and the vallecula of the epiglottis. Since both food and air pass through the pharyngeal hrus (PHR), when food is swallowed, a connective tissue flap called the epiglottis (EP) covers the glottis (not shown for simplicity) to prevent aspiration. The pharynx and larynx are the part of the throat that connects to the esophagus (ES) and are located below the epiglottis (EP). Below the tongue (T) are 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).

[0022] Figure 2A is a schematic isometric view of a portion of the patient's skull, viewed upward toward the mandible M. Figure 2A also shows the hypoglossal nerve HGN, which innervates the muscles controlling the patient's tongue T (Figure 1). In a typical embodiment, one or more electrodes 131 are positioned along the hypoglossal nerve HGN, particularly at the medial branch of the HGN, within an electrode plane 132 defined by the medial branch. By precisely positioning the electrodes 131 within this plane 132 and adjacent to the hypoglossal nerve HGN, the system according to the embodiment of the Art can more effectively control the patient's airway patency without causing discomfort and / or other undesirable effects, and / or reducing the amount of power required to produce an effective therapeutic signal. Other typical target nerves, as described elsewhere in this specification, include the cervical sworn nerve and the vagus nerve. Yet another typical target is the cranial nerve (e.g., glossopharyngeal nerve) and the palatoglossus muscle. Figure 2B shows these targets. Representative systems that produce the above and / or other results using signals directed to the above targets are described below with reference to Figures 3 to 8B.

[0023] 3. Typical Instruments and Methods Figure 3A is a block diagram showing the components of a system 100 for treating sleep disorders according to an embodiment of the present technology. The system 100 may include a wearable device 101 (hereinafter sometimes referred to as "wearable"), a charger 121, one or more implants or implantable devices (e.g., a first implantable device 120a, a second implantable device 120b...nth implantable device 120n (collectively referred to as "implantable device 120"), and a connected device or programmer 160. Generally, the programmer 160 can transmit commands to the wearable device 101 to generate electrical signals (e.g., signal transmission or waveform parameters), the wearable device 101 can transmit commands and power to the implantable devices 120, and each implantable device 120 can generate electrical signals according to the transmitted commands and apply these electrical signals to the patient via electrodes carried by the implantable devices 120. Many of the above aspects of the system 100 will be described in detail below with reference to Figure 3B.

[0024] The programmer 160 may include a patient-operated programmer and / or a physician-operated programmer, which may be configured to control one or more characteristics of an electrical signal delivered to the patient. In a typical embodiment, the programmer 160 may include a therapeutic adjustment module configured to select individual electrodes carried by the implantable device 120 and adjust (e.g., increase or decrease) the amplitude, frequency, pulse width, burst duration (whether the electrodes are active or inactive) and / or any other appropriate signal delivery parameters. In addition, the programmer 160 may synchronize information received from individual wearables 101 and / or implantable devices 120 (e.g., diagnostic and / or feedback information) and adjust one or more of the signal delivery parameters based at least partially on the synchronization information. The programmer 160 may transmit the signal delivery parameters directly to the implantable device 120 and / or via the wearable device 101. For example, the programmer 160 may be connected to individual implantable devices 120 and / or wearable devices 101 by wired or wireless communication links, such as Wi-Fi, Bluetooth® (BT), cellular connection, and / or any other suitable communication link. In these and other embodiments, the programmer 160 may be connected to a cloud 162 and / or other computer service to upload data received from sensors on the wearable device 101 and / or download information to the wearable device 101 and / or implantable devices 120. In these and other embodiments, the programmer 160 may include a display and / or a user interface. A user (e.g., a patient, a physician, and / or other suitable user) may interact with and / or control one or more aspects of the programmer 160, for example, through the user interface, thereby manually adjusting one or more of the signal transmission parameters, reading data received from sensors on the wearable device 101, and / or performing other tasks.

[0025] The wearable device 101 may have one or more sensors (e.g., a single sensor, an array of sensors, and / or other suitable sensor arrangements) configured to collect patient-related data. The wearable device may further have a power source (e.g., a power storage device and / or battery), a power transmission component configured to transmit power and / or signal transmission parameters to the implantable device 120, and one or more algorithms configured to control one or more aspects of the operation of the wearable device 101. The individual sensors may collect patient-related data, e.g., the patient's sleep state and / or respiratory performance. One or more algorithms may be configured, at least in part, to adjust at least one of the signal transmission parameters based on the data collected by the sensors. In a typical embodiment, the wearable 101 may have an integrated sleep, respiratory diagnostic, and / or therapeutic modulation system configured to adjust or otherwise control, for example, one or more transmission parameters of electrical signals transmitted to the patient via one or more algorithms, based on the collected sleep state and / or respiratory performance data.

[0026] In some embodiments, the wearable device 101 may further have a cover or housing, at least a portion thereof may be removable to expose the interior or a portion thereof of the wearable device 101. In this embodiment and other embodiments, the cover of the wearable device 101 may include a textile or any other suitable material. Optionally, the wearable device 101 may have a reduced and / or simplified user interface configured to allow the user to interact with and / or control one or more components of the wearable device 101 in a different way (e.g., to check the charge status of the power supply, adjust one or more signal transmission parameters, etc.).

[0027] The charger 121 for the wearable device 101 is preferably configured to supply power to the wearable device 101's power source. The charger 121 may include a wireless (e.g., inductive) charger, a wired charger (e.g., a wall plug, a charging cable, etc.), and / or any other suitable charger or charging device. Optionally, the charger 121 may have, for example, an integrated controller and / or a connected device for controlling the charging of the wearable device 101 and / or uploading / downloading data to / from the wearable device 101 while the wearable device 101 is charging.

[0028] Each of the one or more implantable devices 120 may have an RFID (e.g., an unambiguous RFID tag that can be used to identify and / or locate the associated implantable devices 120a-120n), an electrode receiver antenna (e.g., an RF power antenna), a power rectifier (forward converter) / DC-DC converter, a circuit section (e.g., one or more application-specific integrated circuits (ASICs), state machines, etc.), a signal generator, and two or more electrodes, each individually selectable to send an electrical signal to the patient. The electrode receiver antenna may receive power from the power transmission component of the wearable device. The power rectifier / DC-DC converter may be operably coupled to the electrode receiver antenna and may be configured to transmit the received power to the signal generator. In addition, each of the implantable devices 120 may receive information via the electrode receiver antenna about one or more of the transmission parameters of an electrical signal to be generated by the signal generator and / or sent to the patient via at least one of the electrodes of the implantable device 120. The circuit section may include machine-readable instructions related to the operation of the implantable device 120. For example, the circuit section may include instructions that, at runtime, cause a signal generator to generate an electrical signal having signal transmission parameters received via an electrode receiver antenna. In these and other embodiments, the electrode receiver antenna may be used to transmit information related to the implantable device 120 to the wearable device 101. For example, the implantable device 120 may transmit information related to one or more signal transmission parameters of an electrical signal applied to the patient to the wearable device 101 via the electrode receiver antenna. In these and other embodiments, each of the one or more implantable devices 120 may have an airtight package or housing configured to allow the implantable device 120 to be implanted in the patient's body.

[0029] Figure 3B is a partial schematic isometric view of a typical embodiment of system 100 of Figure 3A, shown in relation to the patient's anatomical structure, from a similar viewpoint to the above-described figure with reference to Figure 1. In a typical 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 delivery device 130 positioned adjacent to a target nerve and / or muscle structure. The signal delivery device 130 may be fixed in place by sutures and / or other devices, such as anchors. The signal delivery device 130 is operably coupled to a signal generator 110. In some embodiments, all signal generation functions are performed by the implantable devices 120, and in other embodiments, some signal generation functions are performable by external components. The signal generation and signal delivery functions may be performed by a single implantable device 120 or by multiple devices.

[0030] The wearable device 101 is preferably equipped with a power supply 109. For illustrative purposes, the wearable device 101 is shown in Figure 3B as including an oral device 123, e.g., a mouthpiece, which is equipped with a power supply 109. As described above, the wearable device 101 may have other suitable configurations in other embodiments (e.g., a collar, chin strap, pillow, mattress overlay). The power supply 109 provides power to a signal generator 110, which generates signals (e.g., therapeutic signals) and directs these signals to one or more electrodes 131 carried by a signal transmitting device 130. The signal transmitting device 130 is preferably implanted at or near the hypoglossal nerve HGN of the patient using a minimally invasive method, e.g., a transdermal needle. The power supply 109 provides power to the signal generator 110 via a wireless power transmission link 114, e.g., a midfield RF transmission link.

[0031] The signal generator 110 is typically controlled by a wearable device 101, which is preferably controlled via a wireless programmer link 161 by a programmer 160 and / or any other suitable device. Thus, the patient P and / or physician can use the programmer 160 to direct the signal generator 110 (by the wearable device 101), thereby sending specific signals to specific electrodes at specific times and / or in specific sequences. The programmer link 161 is preferably a bidirectional link, so that the programmer 160 (in addition to providing commands to the wearable device 101 and / or the signal generator 110) can receive data on treatment, the status of system components, and / or other suitable metrics. The data is preferably collected by one or more sensors 119 carried by the wearable device 101 (as schematically shown in Figure 3B) and / or an implantable device 120. In addition, the programmer 160 can communicate with the cloud 162 and / or other computer services to upload data received from patient P and / or download information to the wearable device 101 and / or implantable device 120. The downloaded data may include instructions and / or other data regarding appropriate treatment (e.g., from other patients in similar situations), updates to software running on circuits carried by the wearable device 101 and / or implantable device 120, and / or other useful information. In other embodiments, the implantable device 120 and / or wearable device 101 include state-of-the-art mechanical components that are not updatable. Representative data received from the patient should preferably include, in particular, respiratory rate, sleep state, wakefulness state, heart rate, voice signals (audible snoring, hypopnea events, and / or apnea events), body temperature, head orientation / position, saturated blood oxygen level, airflow level, thyroid movement, tracheal movement, and / or tongue movement, and photoplethysmography (PPG) data. The data received from the patient should preferably be generated by 119 carried by a wearable device 101 and / or an implantable device 120.In a typical embodiment, the wearable device 101 performs execution functions, such as synchronizing information received from the programmer 160 and / or sensor 119 to start, adjust, and / or stop the treatment provided to the patient. Therefore, the circuitry carried by the wearable device may include a controller programmed with commands to start, modify, and / or stop the treatment sent to the implantable device based on information received from the sensors. The received data may correspond to measures of metrics used to rate the patient's respiratory performance, sleep state, wakefulness state, and / or other appropriate metrics, such as the apnea-hypopnea index (AHI).

[0032] In any of the embodiments described above, the wearable device 101 transmits power to the implantable device 120 via one or more power transmission links 112, or receives power from the charger 121 (for example, intermittently). The charger 121 is therefore preferably a conventional inductive coupling device (e.g., Qi standard charging) and / or a conventional wired connection, as described above and with reference to Figure 3A.

[0033] For comfortable wear, the wearable device 101 (whether an oral device 123 or another form of wearable) is preferably custom-fittable to the patient, or made available in various sizes, and / or partially configurable to suit individual patients. The oral device 123 is optimal when the associated signaling device 130 is positioned at or near the target nerve population in the oral cavity (e.g., HGN). Whether the wearable device has a mouthpiece shape factor or another suitable shape factor, power can be supplied to the implantable device 120 even when the wearable device is used to target nerve populations other than and / or in addition to HGN, e.g., the vagus nerve and / or branches of the cervical nerve loop. In yet another embodiment, the power source 109 can be attached to the patient's skin with adhesive, but it is expected that avoiding adhesive will be more desirable / effective for the patient.

[0034] Referring to a specific embodiment shown in Figure 3B, the oral device 123 may have both an upper mouthpiece portion 111 and a lower mouthpiece portion 112. The two mouthpiece portions 111, 112 may be connected to each other by a connector 113. The connector 113 can provide a wired communication link between the two mouthpiece portions and / or the connector 113 can mechanically position (and / or maintain or stabilize) the lower mouthpiece portion 112 relative to the upper mouthpiece portion 111. Using this method, for example, the patient's lower jaw or mandible M can be advanced relative to the patient's maxilla, indicated by the bone structure BS in Figure 3B. For example, embodiments of the present technology use physical elements of the wearable device 101 in addition to electrical stimulation powered by the wearable device to avoid or at least reduce jaw laxity (a state in which the patient's mouth is open). For example, a wearable device with a collar and / or chin strap can mechanically stabilize the patient's jaw in a target position.

[0035] The power supply 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 in a manner that allows it to be transmitted to the signal implantation device 120. Therefore, the power supply 109 may have a circuit section 115 (e.g., a first circuit section) that receives power from the charge storage devices 116, adjusts this power, and transmits this power to the power transmitting antenna 118. The power transmitting antenna 118 transmits the power to the implantation device 120 via a wireless power transmission link 114 and an electrode receiver antenna 133 supported by a signal transmission device 130.

[0036] The oral appliance 123 may further have a data transmission antenna 117 that receives data from and / or transmits data to the programmer 160. The data transmitted to the programmer 160 may include sensor data obtained from one or more sensors 119. Therefore, the oral appliance 123 may carry the functional elements / components necessary to direct power to the signal transmission device 130 and may communicate with the programmer 160 to provide effective treatment for the patient. Further details of the signal transmission device 130 and the signal generator 110 will be described below with reference to Figures 4 to 8B.

[0037] Figure 4 is a partial schematic side view of a signaling device 130 having components configured according to a typical embodiment of the present technology. Typical dimensions are shown in Figure 4 to provide a sense of scale, but the present technology is not limited by these dimensions unless explicitly specified. The signaling device 130 has a lead body 134 which is preferably flexible as a whole and capable of carrying one or more electrodes 131, the one or more electrodes 131 which are preferably rigid as a whole in some embodiments and flexible in other embodiments. Flexible electrodes increase the overall flexibility of the lead body to accommodate the winding anatomical structures / insertion paths near the target nerve. For illustrative purposes, the lead body 134 is shown in Figure 4 as carrying four electrodes 131, but in other embodiments, the lead body 134 may carry any other suitable number of electrodes, e.g., two electrodes 131. The electrodes 131 are preferably arranged in an array, for example, a one-dimensional linear array. The electrodes 131 may include conventional ring-shaped or cylindrical electrodes made of a suitable biocompatible material, such as platinum / iridium, stainless steel, MP35N, and / or other suitable conductive implant materials. Each electrode 131 may be connected to an individual conductor 140, such as 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 Figure 4, or may have a different suitable length in other embodiments. To form a closed circuit, the electrodes 131 may typically be connected to each other in pairs (at least one pair at a time). The housing 135 and / or some parts of the housing 135 may function as electrodes, for example, as a ground electrode or a return electrode.

[0038] The lead body 134 is connected to and supported by the housing 135, which supports the signal generator 110 and circuit elements for receiving power. For example, the entire housing 135 may have 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 support a receiver antenna 133 (or other suitable power receiving device) that receives power from a wearable device 101 (Figures 3A and 3B) via a wireless power transmission link 114. The circuit housing 135b may be in the form of a circular metal "can" made of titanium and / or another suitable material. The signal generator 110 may have a charge pump and / or a DC-DC converter 139 and / or a circuit section 138 (e.g., a second circuit section) coupled to the receiver antenna 133. The circuit unit 138 preferably has an ASIC which includes corresponding machine-readable instructions. The instructions are preferably 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. The data can also be transmitted in the reverse direction using, for example, backscattering and / or other suitable techniques. For example, the implantable device 120 may transmit an indication that power has been received and how much power it is. This information can be used to self-adjust (up or down) the output of the signal generator 110, for example, the transmitted signal and phase. Therefore, the circuit unit 138 preferably has a processor and memory for sending therapeutic signals to the patient, and such processor and memory may include pre-programmed and updateable instructions (for example, in the form of an ASIC). For example, the system may include bootloader-integrated firmware. Furthermore, the entire system can identify a number of implantable devices that are better powered by a single wearable device 101 using RFID-type power transmission authentication.It is preferable to implement security measures using RFID and / or other technologies to prevent foreign objects from causing unintended disturbances. Such technologies can be implemented in at least some embodiments by appropriate hardware / software implemented in the implantable device 120.

[0039] The entire housing portion 135 may further have a rigid base 136 and one or more anchors 137. The anchors 137 securely position the implantable device 120 relative to the patient's tissue. In a typical embodiment, the anchors 137 have one or more teeth that extend outward and into the patient's tissue when the implantable device 120 is injected into the patient's body or implanted in a different manner. In other embodiments, the implantable device 120 may have other suitable anchors, and / or the tethering may occur at the distal and / or intermediate sections of the signaling device 130. Other suitable anchors include, but are not limited to, (a) a bow spring extending along the longitudinal length of the electrode array and bending to create a fixed frictional force when the introduction sheath is withdrawn; (b) a thin wire provided on a spring-compression hinge, extending along the longitudinal length of the electrode array and bending to create a fixed frictional force when the introduction sheath is withdrawn; (c) a cam that expands in diameter when rotated and creates a frictional locking action when the corresponding push rod is rotated by the implanter; and / or (d) a torsion spring that expands in diameter when rotated and creates a frictional locking action when the corresponding push rod is rotated by the implanter.

[0040] To implant the implantable device 120, the physician positions the implantable device 120 at the desired target location using a typical set of percutaneous implant tools, such as an introducer, needle, cannula, and stylet. In certain embodiments, the implantable device 120 is implanted percutaneously with a 3-4 French needle. As the implantable device 120 is advanced from the cannula, the anchor 137 can be deployed outward and fix the implantable device 120 in place. When the stylet is removed from the implantable device 120, for example by axially withdrawing it from a hole in the base 136 and / or other parts of the housing portion 135, the implantable device 120 is ready to receive power and send therapeutic signals to the target nerve.

[0041] To explain the operation, the receiving antenna 133 wirelessly receives power from a power source 109 carried by the associated wearable device 101 (described in further detail below with reference to Figures 3A and 3B, and Figures 5A to 6). In at least some embodiments, the power received at the receiving antenna 133 is in the midfield range, specifically in radio frequency states in the range of, for example, about 300 MHz to about 6 GHz, for example, about 600 MHz to about 2.45 GHz, or about 900 MHz to about 1.2 GHz. At this frequency, the usable range of the wireless power transmission link 114 is about 10 cm, well beyond the distance between the implanted device 120 and the wearable device 101. In this range, the power transmission process is not expected to cause tissue heating and therefore offers advantages compared to other power transmission technologies, such as inductive power transmission technologies. However, in embodiments where the potential heating caused by the inductive power transmission system is moderately controlled, dielectric technology can be used instead of the midfield power transmission technology described herein.

[0042] The AC power received at the receiver antenna 133 is rectified to DC, then transmitted to a DC-DC converter, charge pump, and / or transformer 139, and converted into pulses in the range of approximately 10 Hz to approximately 300 Hz. In other embodiments, the pulses may be transmitted at a high frequency (e.g., 10 kHz or higher) and / or in burst form. The amplitude of the signal may be approximately 1 mV to approximately 5 V (1 V to 2 V in certain embodiments) in voltage-controlled systems, or approximately 1 mA to approximately 6 mA in current-controlled systems. The circuit section 138 controls these signal transmission parameters and transmits the resulting electrical signal to the electrode 131 via the wire filament or other conductor 140 in the lead body 134. Thus, the circuit section forms (or forms at least part of) a signal generator 110, which receives power wirelessly transmitted to the implantable device 120 and generates a signal that is ultimately transmitted to the patient. The electric field generated as a result of the current flowing through the electrode 131 produces the desired effect (e.g., excitation and / or inhibition) at the target nerve. In at least some embodiments, the implantable device 120 does not need to include any onboard power storage elements (e.g., power capacitors and / or batteries) to reduce the system volume, nor does it need to include any power storage elements with a storage capacity of more than 0.5 seconds. In other embodiments, the implantable device 120 may have one or more small charge storage devices (e.g., capacitors) that are compatible with the overall compact form of the implantable device 120 and, depending on the embodiment, 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.

[0043] In at least some embodiments, the electrical signal delivered to the patient is preferably delivered by a bipole formed by two of the electrodes 131. In other embodiments, the signal is preferably a unipolar signal, and the housing 135 (e.g., circuit housing portion 135b) forms a ground electrode or a return electrode. Generally, the waveform includes a biphasic, charge-balanced waveform, as will be described in detail below with reference to Figures 8A and 8B.

[0044] Figures 5A to 6 show a wearable device 101 configured to supply power to an implantable device 120 according to a typical embodiment of the present invention. Referring first to Figure 5A, a typical wearable device 101 includes an oral device 123 comprising an upper mouthpiece portion 111 and a lower mouthpiece portion 112. The lower mouthpiece portion 112 has one or more power-transmitting antennas 118 that direct power to the implantable device 120, as described above with reference to Figure 4. In a typical embodiment, the patient wears two implantable devices 120 implanted on both sides, i.e., at each of the patient's two hypoglossal nerves, with one implantable device positioned on the upper right side of the patient's oral cavity and the other implantable device positioned on the upper left side. Therefore, the oral device 123 preferably has two power-transmitting antennas 118, each positioned to direct power to each of the implantable devices 120, respectively. In the embodiment shown in Figure 5A, the lower mouthpiece portion 112 has two corresponding extensions 124, indicated as the left extension 124a and the right extension 124b. Each extension 124 houses each of the power transmitting antennas 118, and each extension is positioned to place the power transmitting antennas 118 near the corresponding implantable device 120 in a manner that remains comfortable for the patient when the patient wears the oral appliance 123.

[0045] The oral appliance 123 further comprises one or more power sources 116 coupled to the circuit section 115, the circuit 115 directing power to a power transmitting antenna 118. The power sources 116 may include one or more batteries, capacitors, and / or other charge storage devices configured to store enough energy to power the signal transmission device for a suitable treatment period. A suitable treatment period is typically at least four hours in some embodiments and at least overnight in other embodiments. The circuit section 115 receives current from the power sources 116 and converts this current into a suitable midfield high frequency. The current is directed to the power transmitting antenna 118. In the embodiment shown in Figure 5A, the circuit section 115 and power sources 116 are supported by a lower mouthpiece section 112, and the circuit section and power sources are positioned along the outer surface of the lower mouthpiece section 112 so as to face the patient's lower lip. In this configuration, the electrical elements are not expected to interfere with the patient's forward movement of the tongue. In another embodiment, for example, as shown in Figure 5B, the circuit unit 115 and the power supply 116 are preferably supported by the upper mouthpiece portion 111. In this embodiment, the circuit unit 115 and the power supply 116 are positioned along the inner surface of the upper mouthpiece portion 111 so as to face inward towards the patient's oral cavity rather than towards the patient's lips. Since the electrical elements are located on the upper mouthpiece portion 111, it is expected that these electrical elements will not interfere with the forward movement of the patient's tongue, even when they are facing inward towards the patient's oral cavity. The circuit unit 115 directs the current to the antenna by one or more wires (not shown in Figure 5A) passing through a connector 113 (shown in Figure 3B) coupled between the upper mouthpiece portion 111 and the lower mouthpiece portion 112 in a corresponding relationship.

[0046] Figure 5C shows another typical embodiment in which the wearable device 101 has a circuit section 115 supported by an upper mouthpiece section 111 and a power supply 116 supported by a lower mouthpiece section 112. In this case, a communication link supported by a connector 113 (Figure 3B) carries current from the power supply 116 to the circuit section 115, and then carries current from the circuit section 115 to a power transmission antenna 118 (not visible in Figure 5C).

[0047] Figure 6 is a partial schematic isometric view of a wearable device 601 configured according to yet another embodiment of the present technology. The upper mouthpiece portion 111 has a roof portion 622 that extends laterally from one side to the other so as to be positioned upward when placed against the patient's palate. Therefore, some of the components of the wearable device 101 may be supported by the roof portion 622. Such components include a circuit unit 115, a power supply 116, a data transmission / reception antenna 117 (described above with reference to Figure 3B), a charging coil 621 (the power supply 116 is recharged by a charger 121 shown in Figures 3A and 3B), and one or more sensors 119 (also described above with reference to Figures 3A and 3B). Therefore, the roof portion 622 can be an additional volume for housing and supporting the above-mentioned components of the wearable device 101. Examples of sensors 119 include, but are not limited to, temperature sensors, such as thermistors and / or thermocouples, acoustic sensors, vibration sensors, pressure sensors, force sensors, strain gauges, magnetometers, accelerometers, gyroscopes, impedance sensors, EMG sensors, gas sensors and / or chemical sensors, oxygen saturation sensors, photoplethysmography sensors, fluid sensors (oral or nasal manometry), and / or other sensors capable of detecting the patient's state or characteristics (e.g., sleep state, wake state). In some representative embodiments, patient respiratory parameters can be used to trigger stimuli based on information that can indicate the patient's respiratory cycle and whether an apnea event is occurring or about to occur. In certain embodiments, the overall system includes a pulse oximeter, a photoplethysmography sensor, and at least one patient localization sensor to provide appropriate patient feedback that should underlie system behavior.

[0048] Any of the components described above with reference to Figures 5A to 6 can be positioned along the outer surface of the mouthpiece, or in other embodiments, these components may face inward rather than outward from the mouthpiece. As mentioned above, the advantage of components located on the outer surface of the mouthpiece is that they do not come into contact with the space occupied by the tongue when the tongue is thrust forward during stimulation. In at least some embodiments, the battery is preferably positioned so that it can be easily removed or replaced.

[0049] Figure 7 is a schematic diagram of a device that controls electrical signals applied to a patient according to a typical embodiment of the present technology. Generally, the control circuit unit 115 supplies current to one or more transmitting antennas 118, which direct the power to corresponding electrode receiver antennas 133 via corresponding wireless transmission links 114.

[0050] For illustrative purposes, Figure 7 shows two control configuration examples provided in a single device, one configuration example for the left side of the patient's oral cavity and the other configuration example for the right side. This is one possible configuration, and in other embodiments, the same configuration example may be used for both the left and right sides. As shown in Figure 7, the first receiver antenna 133a can provide a signal to each of the four corresponding electrodes 131. The two second receiver antennas 133b can each provide power to two electrodes 131. The implemented configuration example should be selected based on its usefulness in relation to the control of individual electrodes by the corresponding receiver antennas. For example, the first receiver antenna 133a can simultaneously send the same signal to a number of electrodes 131 (and / or pairs of electrodes 131) connected thereto. On the other hand, the second receiver antennas 133b can each send signals separately and independently to the corresponding electrodes coupled thereto. This allows the second receiver antennas 133b to sequence the signals applied to the corresponding electrodes 131. In some embodiments, this configuration advantageously allows a physician to direct one signal to one portion of the hypoglossal nerve at one point in time, and the same or another signal to another portion of the hypoglossal nerve or another nerve at a different point in time. As expected, the ability to control both the spatial and temporal aspects of the signals sent to one or more target nerves can improve the efficacy of the device in reducing obstructive sleep apnea (OSA) in patients. For example, it is preferable to send signals to different portions of the hypoglossal nerve and / or other nerves, including the cervical loop (e.g., to facilitate caudal movement of the pharynx) and / or the vagus nerve, when its branches are activating many muscles of the upper airway, including the motor muscles of the pharynx and lingual palate.

[0051] More generally, the multiple injectable electrodes 131 are preferably wirelessly activated by a wearable device remotely positioned in a stepwise manner (e.g., with a timing offset in the millisecond range) to sequence the contractions of the corresponding muscles, thereby addressing the patient's sleep disturbance. In addition, the system has the flexibility to alter the target neurons to which the signals are directed, combined with the reliability and robustness provided by the implanted signaling device.

[0052] In at least some embodiments, the control circuit 115 controls both transmitting antennas 118, thus enabling overall control of the signal delivered to the patient. In other embodiments, it is preferable to distribute the authority to control one or more antennas 118 and / or corresponding electrodes 131. For example, one element of the control circuit may control one transmitting antenna 118, and another element may control the other transmitting antenna 118. It is preferable to further distribute the control authority to different receiving antennas 133, as shown in Figure 7. In any of these embodiments, when control is distributed under the high-level control circuit 115, the system includes means to enable communication between individual controller elements to keep all control components synchronized.

[0053] 4. Typical waveforms The signal generator and transmitter described above can generate and transmit any of a variety of suitable electrical stimulation waveforms, thereby regulating the function of the patient's nerves and / or muscles. Typical embodiments are shown in Figures 8A and 8B, which include a series of biphasic stimulation pulses forming a stimulation wave cycle having a period as specified in Figures 8A and 8B. 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 8A includes an anode pulse, then an interphase delay, then a cathode pulse, then an interpulse delay. Thus, the period P or cycle as a whole includes the following parameters: anode pulse width (PW1), anode amplitude (e.g., voltage or current amplitude VA), interphase delay / dead time, cathode pulse width (PW2), cathode amplitude (e.g., voltage or current amplitude VC), interpulse delay / free time, and peak-to-peak amplitude (PP). The parameters may further include an identification of the electrode that directs the signal. In some embodiments, the anode pulse width (PW1) is 30 μs to 300 μs. In some embodiments, the anode amplitude (VA) and cathode amplitude (VC) are in the range of 1 mV to 5 V, or 1 mA to 6 mA. In typical embodiments, the phase delay is preferably 10 μs to 100 μs. In some typical embodiments, the cathode pulse width (PW1) is 30 μs to 300 μs. In typical embodiments, the anode and cathode phases are charge-balanced, although these phases do not need to be symmetrical. In some typical embodiments, the pulse delay is preferably 10 μs to 100 μs. In some typical embodiments, the peak-to-peak amplitude is preferably about 2 mA to 12 mA. Typical frequencies are in the range of about 10 Hz to about 300 Hz in some embodiments, and up to 100 kHz (e.g., 10 kHz) in other embodiments. These pulses can be sent out continuously or in burst mode.

[0054] Figure 8B shows a typical waveform including the active and resting portions. The active portion includes one or more periods having the characteristics described above with reference to Figure 8A. The resting portion has no stimulation pulses. According to several typical embodiments, the ratio of the active portion to the resting portion is preferably 1:1 to 1:9. In a typical example, if the ratio is 1:9 and there is an active period of 300, there is preferably a resting portion of 2700.

[0055] In typical embodiments, the stimulation voltage is preferably supplied independently to each contact or electrode. For positive pulses, the positive contact is preferably drawn to the driving voltage, and the negative contact to ground. For negative pulses, the negative contact is preferably drawn to the driving voltage, and the positive contact to ground. For dead time and idle time, both contacts are driven to ground. For rest time, both contacts are in a high-impedance state. To prevent DC current in the contacts, each half-bridge is preferably coupled to the contacts by a capacitor, for example, a 100 μF capacitor. In addition, a resistor is preferably placed in series with each capacitor to limit the current in the event of a contact short circuit. The pulses of the therapeutic waveform cycle may or may not be symmetrical, but are generally shaped to produce a net-zero charge across the contacts, for example, to provide charge equilibrium.

[0056] From the above, it will be understood that although specific embodiments of the present technology have been described herein for illustrative purposes, various modifications can be made without departing from the present technology. For example, the power supply and associated wearable may have a configuration that wirelessly transmits power to one or more implanted electrodes other than the oral mouthpiece. Typical configurations include external skin-attached devices and devices worn around the patient's neck, which may be suitable for targeting nerves other than the cervical nerve loop, vagus nerve and / or HGN. Other typical targets for stimulation include tongue-palate stimulation, cranial nerve stimulation, direct tongue-palate muscle stimulation, nasopharyngeal stimulation and / or glossopharyngeal nerve stimulation. The anchors used to fix the signaling device in place may have a form other than deployable teeth, such forms including S-shaped curved elements, helices and / or porous structures that promote tissue inward growth. The signaling device, which includes a plurality of housings forming the entire housing, has been described above. In other embodiments, the plurality of housings may be parts of an entire integrated housing. The functions performed by the entire system can be explicitly illustrated and divided into system components (e.g., programmers, wearable devices, and implantable devices) in ways other than those described herein.

[0057] Certain aspects of the technology described in relation to a particular embodiment can be combined with or omitted by other embodiments. For example, a signaling device having any of a variety of suitable configurations can be used in conjunction with any one signaling generator, and a signaling generator having any of a variety of suitable configurations can be used in conjunction with any one signaling device. Furthermore, while advantages associated with a particular embodiment of the disclosed technology have been described in relation to this embodiment, other embodiments within the scope of the technology may also achieve such advantages, and not all embodiments necessarily achieve such advantages. Accordingly, the disclosure and related technologies may include other embodiments not explicitly illustrated or described herein.

[0058] In this specification, phrases such as “A and / or “B” mean A alone, B alone, or both A and B. In any case of material cited by reference, this disclosure takes precedence to the extent of any conflict. In this specification, terms such as “about,” “approximately,” and similar approximation terms mean values ​​within 10 percent of a specified value.

[0059] The following embodiments provide additional representative features of the technology.

[0060] Embodiment [Implementation item 1] A patient treatment system, This includes wearable devices, and the above wearable devices are, Power storage device, A power transmission antenna is coupled to the above-mentioned power storage device and configured to emit RF signals in a frequency range from 300 MHz to 6 GHz, It has a first control circuit unit coupled between the above-mentioned power storage device and the above-mentioned power transmission antenna, This includes implantable devices, and the above-mentioned implantable devices are, Electrodes and, A housing supporting the above electrodes, An anchor, supported by the housing and positioned to fix the implantable device to the tissue inside the patient's oral cavity, An electrode receiver antenna configured to receive RF signals in the frequency range from 300 MHz to 6 GHz, The electrode receiver antenna and the signal generator coupled to the electrode are used to direct the signal to the electrode at a frequency in the range of 10 Hz to 300 Hz. A patient treatment system comprising a second circuit unit coupled between the signal generator and the electrode to control the transmission of the above signal to the above electrode. [Implementation Section 2] The above-mentioned implantable device is a needle-transmission device, and the electrodes are positioned to be implanted near the patient's hypoglossal nerve and / or cervical nerve loop, and the system further, The device includes at least one sensor carried by the above-mentioned wearable device or implantable device, wherein the at least one sensor is configured to detect the characteristics of the patient's respiratory performance. A patient treatment system according to Embodiment 1, comprising a controller carried by the wearable device and programmed with commands to initiate, modify, and / or stop the transmission of the signal to the electrode, in part based on information received from the at least one sensor during execution. [Embodiment 3] The patient treatment system according to Embodiment 2, wherein the at least one of the sensors includes a pulse oximeter, a photoelectric pulse wave sensor, and a patient positioning sensor. [Embodiment Item 4] The above-mentioned implantable device is a patient treatment system according to any one of embodiments 1 to 3, wherein the implantable device does not include a charge storage element. [Embodiment 5] A patient treatment system according to any one of embodiments 1 to 4, wherein the electrode is a first electrode, the implantable device has a second electrode, at least one of the first circuit or the second circuit includes commands that, in operation, direct signals to the ordered first and second electrodes, the first electrode sends a first signal to the patient at a first time, and the second electrode sends a second signal to the patient at a second time. [Implementation Section 6] The patient treatment system according to any one of embodiments 1 to 4, wherein the wearable device includes an oral device configured to be positioned within the oral cavity of the patient. [Embodiment 7] The patient treatment system according to Embodiment 6, wherein at least a first portion of the oral instrument is shaped to fit at least a second portion of the patient's oral cavity. [Embodiment 8] The patient treatment system according to embodiment 6, wherein the oral appliance has an upper mouthpiece portion, a lower mouthpiece portion, and a connector that connects the upper mouthpiece portion and the lower mouthpiece portion. [Embodiment Item 9] The patient treatment system according to embodiment 8, wherein the lower mouthpiece portion can move relative to the upper mouthpiece portion to advance the mandible of the patient. [Implementation item 10] The patient treatment system according to Embodiment 8, wherein the lower mouthpiece portion supports the power transmission antenna, the charge storage device, and the first circuit section. [Initiative 11] The patient treatment system according to embodiment 8, wherein the lower mouthpiece portion supports the power transmission antenna, and the upper mouthpiece portion supports the charge storage device and the first circuit section. [Implementation item 12] The patient treatment system according to embodiment 11, wherein the upper mouthpiece portion includes a roof portion supporting the charge storage device or the first circuit portion. [Embodiment 13] The patient treatment system according to embodiment 8, wherein the lower mouthpiece portion carries the power storage device, the upper mouthpiece portion carries the first circuit section, and the connector has a communication link for transmitting power from the power source to the circuit section. [Embodiment Item 14] The patient treatment system according to Embodiment 8, wherein at least a portion of the lower mouthpiece portion is shaped to fit the lower oral region of the patient. [Embodiment Item 15] The patient treatment system according to Embodiment 8, wherein at least a portion of the upper mouthpiece portion is shaped to fit the upper oral region of the patient. [Implementation Item 16] i) The implantable device is a first implantable device positioned on a first side of the patient's oral cavity, and (ii) the electrode is a first electrode, and the system further includes a second implantable device positioned on a second side of the patient's oral cavity opposite to the first implantable device, the second implantable device having a second electrode, according to any one of embodiments 1 to 15. [Embodiment Item 17] The above-mentioned wearable device is a patient treatment system according to any one of embodiments 1 to 5, comprising at least one of a neck collar, a chin strap, a pillow, and / or a mattress overlay. [Embodiment 18] At least one of the first circuit section or the second circuit section includes, during execution, a command causing the electrode to send a signal to the patient, the signal being, Pulse width of 30 μs to 300 μs, Anode amplitude of 1mA to 6mA or 1mV to 5V, A patient treatment system according to any one of embodiments 1 to 17, comprising at least one of a cathode amplitude of 1 mA to 6 mA or 1 mV to 5 V. [Implementation item 19] The patient treatment system according to Embodiment 1, wherein the wearable device further comprises at least one sensor positioned to detect at least one physiological parameter of the patient, the at least one physiological parameter including at least one of respiratory rate, heart rate, voice signal, body temperature, head position, saturated blood oxygen level, airflow level, patient laryngeal movement, and / or patient tongue movement. [Embodiment 20] A sleep apnea treatment system, This includes an oral appliance configured to fit inside the patient's oral cavity, and the oral appliance is A lower mouthpiece portion supporting a transmitting antenna configured to emit an RF signal at a first frequency, and It has an upper mouthpiece portion located on the opposite side of the lower mouthpiece portion, and the upper mouthpiece portion is A power storage device operably coupled to the above-mentioned power transmission antenna, and It supports the first control circuit unit which is operably coupled to the above-mentioned power storage device and the above-mentioned power transmission antenna, It has a connector that connects the lower mouthpiece portion and the upper mouthpiece portion. This includes implantable devices, and the above-mentioned implantable devices are, Electrodes and, An electrode receiver antenna configured to receive the RF signal emitted by the above-mentioned power transmitting antenna, A signal generator coupled to the electrode receiver antenna and the electrode, capable of directing a stimulus signal to the electrode at a second frequency, and A sleep apnea treatment system having a second circuit unit coupled between the signal generator and the electrode to control the transmission of the above-mentioned stimulus signal to the electrode. [Implementation Clause 21] The above-mentioned implantable device is a sleep apnea treatment system according to embodiment 20, wherein the implantable device does not include a charge storage element. [Embodiment Section 22] The sleep apnea treatment system according to Embodiment 20 or 21, wherein the electrode is a first electrode, the implantable device has a second electrode, and at least one of the first circuit or the second circuit includes, at runtime, instructions to direct a signal to the ordered first and second electrodes, the first electrode sends a signal to the patient at a first time, and the second electrode sends a signal to the patient at a second time. [Embodiment 23] A method of directing electrical signals to an individual, The process includes the step of transmitting a first electrical signal via a power transmitting antenna of a wearable device which is programmed to establish a wireless communication relationship with a receiver antenna of an implantable device, wherein at least a portion of the first electrical signal has a first frequency in a first frequency range from about 300 MHz to about 6 GHz. Program the pulse generator of the above implantable device, The first electrical signal is received via the electrode receiver antenna described above, and A method comprising the step of transmitting a second electrical signal through at least one electrode of the implantable device positioned to electrically communicate with a target nerve of the individual, wherein at least a portion of the second electrical signal has a second frequency in a second frequency range up to 100 kHz. [Embodiment Section 24] The method according to Embodiment 23, wherein the first frequency range is from approximately 900 MHz to approximately 1.2 GHz. [Embodiment 25] The method according to embodiment 23 or 24, wherein the second frequency range is from about 10 Hz to about 300 Hz. [Embodiment Clause 26] The method according to any one of embodiments 23 to 25, wherein the portion of the second electrical signal described above further has an anode amplitude in the range of 1 mV to 5 V or 1 mA to 6 mA. [Embodiment 27] The method according to any one of embodiments 23 to 26, wherein the above portion of the second electrical signal further has an interphase delay in the interphase delay range of 10 μs to 100 μs. [Embodiment 28] The method according to any one of embodiments 23 to 27, wherein the above portion of the second electrical signal further has an interpulse delay in the interpulse delay range of 10 μs to 100 μs. [Embodiment Section 29] The method according to any one of embodiments 23 to 28, wherein the portion of the second electrical signal described above further has a peak-to-peak amplitude within a peak-to-peak amplitude range of 2 mA to 12 mA. [Embodiment 30] The above-mentioned individual suffers from sleep apnea, according to any one of embodiments described in sections 23 to 29. [Embodiment 31] The method according to any one of embodiments 23 to 30, wherein the step of programming the pulse generator includes the step of programming the pulse generator to send the second electrical signal over a treatment period. [Embodiment 32] The above treatment period lasts for at least 4 hours, according to the method described in Embodiment 31. [Embodiment 33] The method according to Embodiment 31, wherein the above treatment period includes at least one active portion and at least one resting portion. [Embodiment 34] A method of treating patients, The steps include: percutaneously implanting an implantable device near the medial branch of the hypoglossal nerve in the patient, and positioning the electrode supported by the implantable device so as to establish an electrical connection with the medial branch of the hypoglossal nerve in the patient; The steps include transmitting a first signal from the power transmitting antenna of a wearable device to the receiving antenna of the implanted device, The steps include converting the first signal to a second signal using the signal generator of the implantable device described above, A method comprising the step of applying the second signal to the medial branch of the hypoglossal nerve of the patient via the electrodes described above. [Embodiment 35] The method according to Embodiment 34, wherein the step of transmitting the first signal includes the step of transmitting the first signal in a frequency range from about 300 MHz to about 6 GHz. [Embodiment 36] The method according to embodiment 34 or 35, wherein the step of transmitting the second signal includes the step of transmitting the second signal in a frequency range up to 100 kHz. [Embodiment 37] The method according to any one of embodiments 34 to 36, wherein the step of transmitting the second signal includes the step of transmitting the second signal in a frequency range of about 10 Hz to about 300 Hz. [Embodiment 38] The above electrode is the first electrode, and the above step of applying the second signal is, The steps include applying a first portion of the second signal at a first time point via the first electrode, The method according to any one of embodiments 34 to 37, comprising the step of applying a second portion of the second signal at a second time point via the second electrode. [Embodiment 39] The above-mentioned implantable device is the first implantable device, the above-mentioned electrode is the first electrode, and the above-mentioned method is The method according to any one of embodiments 34 to 38, further comprising the step of percutaneously implanting a second implantable device so that a second electrode supported by the second implantable device is positioned to establish an electrical connection with at least a portion of the patient's hypoglossal nerve, cervical loop, vagus nerve, glossopharyngeal nerve, palatoglossus muscle, or nasopharyngeal complex. [Embodiment Item 40] The step of implanting the first implantable device described above includes the step of implanting the first implantable device in the first side of the patient's oral cavity, The method according to embodiment 39, wherein the step of implanting the second implantable device includes the step of implanting the second implantable device in the second side of the patient's oral cavity.

Claims

1. A sleep apnea treatment system, External devices including a wireless power transmission device configured to generate wireless power signals, It has a planted device, The aforementioned implantable device comprises a housing configured to be injectable percutaneously, A flexible lead comprising a proximal portion configured to be connected to the housing, a distal portion facing the proximal portion, and one or more electrodes at least partially disposed between the proximal portion and the distal portion, An anchor device connected to the distal portion of the flexible lead, A power receiving device disposed within the housing and configured to receive power via the wireless power signal generated by the wireless power transmission device, A sleep apnea treatment system characterized by comprising a signal generator disposed within the housing and configured to receive power from the power receiving device and to send electrical signals to the patient's target tissue to the individual electrodes of one or more electrodes.

2. The sleep apnea treatment system according to claim 1, wherein the anchoring device comprises one or more deployable structures configured to extend outward from the distal portion of the flexible lead.

3. The sleep apnea treatment system according to claim 1, wherein the anchoring device is a first anchoring device, and the implantable device further includes a second anchoring device positioned proximal to the first anchoring device and one or more electrodes.

4. The sleep apnea treatment system according to claim 1, wherein the external device includes a wearable collar and / or chin strap.

5. The external device further includes one or more sensors configured to detect at least one of the patient's heart rate or respiratory rate. The sleep apnea treatment system further includes a controller programmed with multiple commands, The command, when executed, causes the controller to determine the patient's sleep state and / or the patient's airflow event based at least partially on the input from one or more sensors, The sleep apnea treatment system according to claim 1, wherein the command, when executed, generates the wireless power signal in the wireless power transmission device based at least in part on the determined sleep state and / or the determined airflow event.

6. The sleep apnea treatment system according to claim 5, wherein the controller is connected to the external device.

7. The external device further includes one or more sensors configured to detect the patient's blood oxygen saturation and / or one or more acoustic signals from the patient. The sleep apnea treatment system further includes a controller programmed with multiple commands, The command, when executed, causes the controller to determine, at least partially, that the patient is experiencing apnea and / or hypopnea, The sleep apnea treatment system according to claim 1, wherein the command generates the wireless power signal in the wireless power transmission device based at least in part on the determination that the patient is experiencing the apnea and / or hypopnea.

8. The sleep apnea treatment system according to claim 1, wherein the implantable device comprises one or more charge storage devices configured to be operably connected to the power receiving device and to store at least a portion of the power received via the wireless power signal for a certain period of time.

9. The sleep apnea treatment system according to claim 8, wherein the aforementioned period is 5 minutes or less.

10. The sleep apnea treatment system according to claim 8, wherein the aforementioned period is one minute or less.

11. The sleep apnea treatment system according to claim 1, wherein at least a portion of the electrical signal has a frequency within the frequency range of 10 Hz to 300 Hz.

12. The sleep apnea treatment system according to claim 1, wherein the wireless power transmission device includes an inductive power transmission device, and the wireless power signal includes an inductive power signal.

13. The sleep apnea treatment system according to claim 1, wherein the wireless power transmission device includes an RF antenna, and the wireless power signal includes an RF power signal.

14. The sleep apnea treatment system according to claim 1, wherein the implantable device is configured to be implantable in the patient using a transdermal injection needle.

15. The sleep apnea treatment system according to claim 1, wherein the housing is configured to be implantable in the patient via a transdermal injection needle.

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