System and method to remedy sleep disordered breathing

Abstract

To provide an electric stimulation system to remedy sleep disordered breathing.SOLUTION: A system 10 can include a nerve modulation device 20, an electronic equipment package 30 which may be a part of the nerve modulation device, an external controller 100, a sensor, and a computing device. The nerve modulation device can include a nerve modulation lead having a lead body 80 configured to be bent to a desired shape and to maintain the shape for positioning an electrode with respect to a structure of a nerve and / or a muscle when fully deployed. The nerve modulation device can also include an antenna 32 including an upper coil and a lower coil electrically connected to each other in parallel. The computing device can execute a closed loop algorithm on the basis of data detected physiologically with respect to sleep.SELECTED DRAWING: Figure 1

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application was filed on May 2, 2019, the disclosure of which is incorporated herein by reference in its entirety. This application claims the benefit of U.S. Provisional Patent Application No. 62 / 841,978. [Technical field]

[0002] An electrical stimulation system for improving sleep disordered breathing is provided. [Background technology]

[0003] Obstructive sleep apnea (OSA) is the most common type of sleep apnea and causes breathing problems. Despite attempts to reduce the risk of developing complete or partial upper airway obstruction during sleep, OSA is characterized by a lack of sleep and is usually associated with reduced blood oxygen saturation. People rarely notice shortness of breath even when they wake up. This is often It is perceived as a problem by others who observe the individual during the illness, or due to its effects on the body. OSA is commonly associated with snoring. OSA is characterized by daytime symptoms (e.g., excessive daytime snoring). Symptoms may persist for years or even years without recognition. It can exist for decades, during which time an individual may experience symptoms associated with significant levels of sleep disturbance. People who sleep alone may become accustomed to the daytime sleepiness and fatigue that comes with it. A designated bedmate notices the symptoms and helps the individual become aware of the condition without the individual being made aware of it. This often doesn't happen.

[0004] The current most widely used therapeutic intervention to treat OSA is positive airway pressure. Positive airway pressure allows the respirator to push air through a mask worn over the nose, mouth, or both. The additional pressure opens up relaxed muscles. There are several mechanisms for treating OSA with positive airway pressure therapy. The most common treatment involves the use of a continuous positive airway pressure (CPAP) machine. It is worn by OSA patients at night while they sleep, and the patient is hooked up to an air pump that maintains positive airway pressure. Wear a mask connected to the

[0005] Neurostimulation is an alternative for patients who cannot use continuous positive airway pressure devices. One neurostimulation system may be designed to prevent the neurostimulation system from collapsing onto the airway. In the hypoglossal nerve (HGN), it detects respiratory movements and increases muscle tone at the back of the tongue. Deliver mild electrical stimulation. HGN innervates the tongue musculature. Motor stimulation of the tongue muscles. -Provides control and aids in important voluntary and involuntary functions, such as swallowing, speaking, and chewing Stimulation of the HGN may help alleviate the symptoms of obstructive sleep apnea, a vital neurotransmitter that, when relaxed, may lead to obstructive sleep apnea. This may restore muscle tone.

[0006] Conventional HGN neurostimulation systems use electrodes, e.g., that surround or are attached to the HGN. Utilizing a stimulation lead that is implanted in the patient's neck / throat with a cuff electrode in close proximity to the The leads are connected via wires to a pulse generator that is implanted under the skin in the patient's chest. From time to time, the pulse generator is surgically accessed for battery replacement. The system includes a handheld patient controller that can be switched on before sleep. .

[0007] HGN neurostimulation has been shown to be an effective treatment for OSA, but Most of the previous systems, as well as the procedures for implanting, using, and maintaining the system, The degree of invasiveness is undesirable. Summary of the Invention

[0008] Provided herein is a neuromodulation system. In one aspect, the neuromodulation system comprises: A neuromodulation device, an electronics package that may be part of the neuromodulation device, and an external The neuromodulation device includes an internal controller, a sensor, and a computing device. The device includes a neuromodulation lead having a lead body including a right portion, a left portion, and an intermediate portion. A plurality of electrodes may be disposed on the lead body. In particular, the left set of electrodes may be disposed on the lead body. The left set of electrodes may be disposed on the left portion of the body and the right set of electrodes may be disposed on the right portion of the lead body. At least one of the plurality of electrodes is configured to deliver a stimulation signal to a target site. The lead body may be a stimulation electrode attached to the neuromodulation lead when the neuromodulation lead is fully deployed. The lead body may be biased toward a substantially omega shape and / or The middle section is inferior to the left and right sets of electrodes when the neuromodulation lead is fully deployed. The antenna may be biased toward a position of operatively coupling to a neuromodulation lead configured to generate an induced current in response. The antenna has an upper coil and a lower coil electrically connected in parallel to each other. The electronics package may include an electronic device for controlling application of a stimulation signal through the stimulation electrodes. The external controller may include electrical components. The external controller may be configured to control the control unit and to apply electrical current to the neuromodulation leads. The antenna can be energized to generate an electromagnetic field for inducing a current in the antenna to power the antenna. The computing device may include a power mat supporting one or more power transmission coils. The device may include a non-transitory memory for storing instructions and a processor. The processor accesses the non-transitory memory and executes instructions to read and write the data recorded by the sensors. monitoring the physiological data; and identifying a trigger within the physiological data, Identifying triggers as biomarkers of sleep-related conditions. and applying rule-based classification to triggers based on one or more parameters of the stimulation signal. determining whether to modify the The stimulation electrodes deliver a stimulation signal to the target site for a period of time, and the computing device configured to modify one or more parameters of the stimulation signal in response to a signal from . [Brief description of the drawings]

[0009] [Figure 1] FIG. 1 illustrates an exemplary configuration of an implantable stimulation system according to one aspect of the present disclosure. [Diagram 2] FIG. 2 is a schematic diagram of an implantable stimulator portion of an implantable stimulation system according to one aspect of the present disclosure. [Diagram 3] 3 is a cross-sectional view taken generally along line 3-3 of FIG. 2 illustrating an antenna portion of the implantable stimulator. [Figure 4] FIG. 1 is a schematic diagram illustrating the flexible nature of an implantable stimulator according to one aspect of the present disclosure. [Diagram 5] FIG. 1 is a schematic diagram illustrating the flexible nature of an implantable stimulator according to one aspect of the present disclosure. [Figure 6] FIG. 1 is a schematic diagram illustrating the flexible nature of an implantable stimulator according to one aspect of the present disclosure. [Figure 7]FIG. 1 is a schematic diagram illustrating an exemplary configuration of a lead portion of an implantable stimulator according to one aspect of the present disclosure. [Figure 8] FIG. 1 is a schematic diagram illustrating an exemplary configuration of a lead portion of an implantable stimulator according to one aspect of the present disclosure. [Figure 9A] FIG. 1 is a schematic diagram illustrating an exemplary configuration of an antenna portion of an implantable stimulator according to one aspect of the present disclosure. [Figure 9B] FIG. 1 is a schematic diagram illustrating an exemplary configuration of an antenna portion of an implantable stimulator according to one aspect of the present disclosure. [Figure 10A] 1 is a schematic diagram illustrating an exemplary configuration of a power mat portion of an electrical stimulation system according to one aspect of the present invention. [Figure 10B] 1 is a schematic diagram illustrating an exemplary configuration of a power mat portion of an electrical stimulation system according to one aspect of the present invention. [Figure 10C] 1 is a schematic diagram illustrating an exemplary configuration of a power mat portion of an electrical stimulation system according to one aspect of the present invention. [Figure 11] FIG. 2 is a block diagram of an example system that can provide neural stimulation with a closed-loop algorithm for treating sleep disordered breathing (SDB), which may be part of the system of FIG. 1. [Figure 12] FIG. 12 is a block diagram of an example of the computing device shown in FIG. [Figure 13] FIG. 1 is a process flow diagram of an exemplary method for providing neurostimulation with a closed-loop algorithm for treating SDB, including OSA. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0010] As used herein in reference to described elements, "a," "an," and "th The terms "e" and "f" refer to the described elements, including combinations thereof, unless otherwise indicated. In addition, unless otherwise indicated, "or" and The term "and" refers to and / or and combinations thereof. "Substantially" means that the shape or configuration of the described element is a mathematically exact representation of the described element. It is not necessary to have the shape or configuration depicted, but the shape or configuration depicted of the depicted elements may be different. The term "shape" refers to a shape or configuration that is recognized by those skilled in the art as generally or approximately having a configuration. As used herein, "stimulation" in the context of neuromodulation means that "Stimulation" or "modulation" includes stimulating or inhibiting neural activity. "Patient" as used herein includes mammals, including humans. "Improve" means that a medical disorder in a patient is alleviated by As used herein, "lower," ... "Superior," "cephalad," and "caudal" refer to the anatomical locations when the patient is in the standard anatomical position. Similarly, the terms "left" and "right" refer to standard anatomical positions. The term refers to the locations of elements corresponding to the left and right sides of the patient's body in a 3D position.

[0011] The present disclosure provides various electrical therapies, including neuromodulation therapies such as nerve and / or muscle stimulation. The present invention relates to an implantable electrical stimulation system 10 that can be used to provide stimulation to a patient. Therapies may induce excitatory or inhibitory nerve or muscle activity. In one exemplary implementation, the system 10 may be used in a variety of suitable locations within a structure. This study aims to treat obstructive sleep apnea (OSA) and other sleep disorders through neuromodulation of the hypoglossal nerve (HGN). It can treat sleep-disordered breathing (SDB).

[0012] Electrical Stimulation System Referring to FIG. 1, the system 10 includes an implantable stimulator 20 (referred to herein as a “neural stimulator”). The controller 100 may include a modulation lead (also referred to as a modulation lead) and an external controller 100. The stimulator 20 can be powered by the antenna via electromagnetic induction. The controller 100 may include a power receiver 30 having an antenna 32. The antenna 32 may generated by the power transmitting antenna 112 when positioned on the mat 112 In the electric field, a current can be induced in antenna 32. Antennas 112 and 32 each have It may also facilitate communication between the controller 100 and the stimulator 20. This power / communications link to and from the controller 100 is generally indicated by arrow 70 in FIG. It is being done.

[0013] The system 10 also includes a controller 100 and a A computer platform that runs custom applications that allow wireless communication The user interface 200 may include a user interface in the form of a platform 202, which may be, for example, This can be done using Bluetooth or WiFi wireless communication. In a typical configuration, the computer platform 202 is a smartphone. However, the type of computer platform 202 may vary. The computer platform 202 may be a physician or patient platform. The platform 202 is a platform for executing applications installed on each platform 202. The app may have user specific, i.e., patient app or The doctor app is installed on the doctor platform. The patient platform will have a patient app installed. The device allows the patient to, for example, start / stop therapy, increase / decrease stimulation power or intensity, and Executes specific commands required to control the operation of the stimulator 20, such as selecting a stimulation program. In addition to the control given to the patient, the doctor app can: The physician can adjust the pulse settings (pattern, duration, waveform, etc.), stimulation frequency, amplitude settings, and and electrode configurations, closed-loop and open-loop control settings, and controls to control therapy delivery during use. Allows modification of stimulation settings, such as tuning parameters of the embedded software It is also possible.

[0014] As generally indicated by arrow 206, computer platform 202 includes a facilitating communication 214 with a remote or cloud-based server 216. The network can be connected (e.g., via WiFi and / or LTE) to the cloud / network 208. , the server 216 and the computer platform 202 via the Internet 208 In addition, the controller 100 itself can be implemented as a You can also connect to the Internet (e.g. WiFi) to allow for The data transfer between the controller 100 and the server 216 is performed via the internet 208. It can also be made possible.

[0015] System Communication As shown in FIG. 1 and described above, system 10 includes various For example, the controller 100 (see 204) and and a computer platform connected to the Internet 208 (see 206). The system 202 transmits the information from the remote server 216 (see 214) to the stimulator 20 itself (see 70). The communication path between the server 216 and the stimulator 20 may be facilitated by the controller 216. It may also be established via a WiFi link 210 of the 100 .

[0016] Further, recognizing that the physician may be remote from the patient, Establish a physician communication pathway via the physician platform's 202 Internet connection 206 Through this connection, the remote physician platform 202 can The remote physician platform can communicate with the server 216 via a network connection 206. The platform 202 can communicate with the internet via an internet connection 210 (if enabled) or Alternatively, the patient controller 202 may communicate with the controller 100 .

[0017] Facilitating local control of the system 10, e.g., the controller 100 and the stimulator 20 In addition, the various communication paths described above may also enable the following: From the server 216 to the computer platform 202, the controller 100, and and / or distribute software / firmware updates for the stimulator 20. From the server 216 to the computer platform 202, the controller 100, and and / or downloading therapy settings / parameters implemented by the stimulator 20. . Facilitates therapy settings / parameter adjustments / algorithm adjustments by remote physicians To make. Uploading data recorded during therapy sessions. - Setting / parameter control by distributing changes and adjustments throughout the system components Maintain consistency of data.

[0018] System Operation Overview The therapeutic approach implemented using the system 10 involves implanting only the stimulator 20 and administering the therapy. This may involve leaving the controller 100 as an external component that is used only during application of To facilitate this, the stimulator 20 is controlled by the controller 100 via electromagnetic induction. In operation, the power supply may be configured to be powered by the control unit 120. The force mat 110 is positioned externally to the patient near the stimulator 20, and the control unit 100 is positioned within the mat. Positioning the transmitting antenna 112 of the controller close to the receiving antenna 32 of the stimulator. In an example implementation in which the system 10 is used to treat OSA, a power mat 1 10 is positioned on or sufficiently close to the sleep surface while the patient is sleeping, and the power amplifier By maintaining the position of the receiving antenna 32 within the target volume of the electromagnetic field generated by the receiving antenna 112, This can be done.

[0019] This approach allows the system 10 to, for example, generate HGNs that are shorter and To improve SDB such as OSA by stimulating through minimally invasive procedures It eliminates the need for on-board implantable power sources in favor of inductive power methods. Eliminates the need for batteries and associated battery replacements over the patient's lifetime It is possible.

[0020] Additionally, the stimulator 20 senses the neuromuscular response to the physiological needs of the patient during sleep. Such sensing electrodes may be implemented to measure physiological changes from the anterior tongue muscles. The endogenous EMG signal can be continuously monitored. For example, the EMG sensing electrodes can be It may be configured to detect neuromuscular responses from the genioglossus muscle innervated by the GN.

[0021] The controller 100 may be configured for multiple purposes, such as: 1) controlling the stimulator 2 during a therapy session; 1) to provide power to the stimulator 110 and 2) to communicate with the stimulator 112. This communication may involve, for example, programming, e.g., software, for the stimulator 20. Uploading software / firmware revisions, changing stimulation settings and / or parameters This may include modifying / adjusting the parameters of the control algorithm. 100% complete programming, software / firmware, and settings / parameters , for example, from the user interface 200 or directly via WiFi, if available. Received via an Internet connection and any of the communication paths listed above. The communication pathway can be used to transmit measurement data regarding completed stimulation therapy sessions. Data from the stimulator 20 can also be downloaded to the controller 100. The controller 100 transmits the downloaded data to the user interface 200. 208, the data can be transmitted to the server 216 via the Internet 208. can be sent / uploaded to

[0022] During operation, the EMG response sensed from the genioglossus muscle enables closed-loop operation of the stimulator 20. By operating in a closed loop, the need for chest leads can be eliminated while The stimulator 20 may, for example, detect momentary occlusions while maintaining stimulation synchronized with respiratory movements. The stimulator 20 can, for example, detect snoring and You can also respond to.

[0023] To facilitate real-time closed-loop control, the control algorithm is implemented on the stimulator 20. It may be implemented locally, for example in an application specific integrated circuit (ASIC) of the stimulator 20. This is achieved by programming the control algorithms on the ASIC components. (See below for a description of the stimulator electronics.)

[0024] By operating in real time, the stimulator 20 can monitor, for example, stimulation settings, EMG responses, Stimulation sensors, including breathing movements and sleep states including different stages of REM and non-REM sleep Data related to the breathing process can be recorded. For example, the phasic and Changes in the EMG activity and sustained EMG activity may serve as triggers for stimulation or may be related to the stimulation. Changes in phasic and tonic EMG activity of the genioglossus muscle during inspiration and during different sleep stages After the sleep session, this recorded data can be used to The patient can upload the patient's medical records to the interface 200 and the server 216. Data regarding the patient's perceived sleep quality may also be uploaded to the server 216. To log, you may be asked to use interface 200. On line, the server 216 adjusts configuration and control parameters to further optimize the stimulation therapy. Run the software application to determine whether it can be The recorded data can be evaluated using software applications, e.g. For example, recorded therapy sessions can reveal how a particular adjustment affects a patient's therapy outcome. This can include an artificial intelligence (AI) model that learns how to improve the model through AI learning. Dell can provide patient-specific, optimized therapy.

[0025] Referring to FIG. 11, the system 300 may be implemented within the system 10 and / or stimulator 20. Implement to provide stimuli to improve SDB following open-loop or closed-loop control The system may include one or more sensors 302 (implantable and / or external). a computing device 304 (implantable and / or Or it may be external and part of another device, such as a controller. 306 (which may be implanted and / or external) , . One or more sensors may include physiological data (e.g., data from the patient's body). ), including changes therein, over time. Empirical data include phasic contractions of the anterior tongue musculature, such as phasic contractions of the genioglossus, tonic activity of the genioglossus, and These may include underlying tonic activity of the anterior tongue musculature, such as muscular movement, and combinations thereof. Phasic contraction of the genioglossus muscle is a phasic contraction that occurs during inspiration, specifically a phasic contraction that is layered within the underlying tonic tone of the genioglossus muscle. Physiological changes may indicate activity in the anterior tongue muscles, such as phasic contractions of the genioglossus. The underlying mechanisms of the anterior tongue musculature, such as changes in the phasic contraction of the musculoskeletal tissue and changes in the tonic activity of the genioglossus, For example, changes in the EMG signal include , which may include changes in frequency, amplitude, spike rate, or other features within the EMG signal. In particular, changes in the phasic contraction of the genioglossus muscle may indicate changes in respiratory movements or inspiration, and may be associated with stimuli. Such physiological data and changes therein can be used as a trigger for inhalation stimulation. During different phases of the respiratory movement, including The one or more sensors 302 may include an EMG sensor. The one or more sensors 302 may also include , e.g., body temperature, movement, breathing sounds (e.g., acoustic sensors), heart rate, pulse oximetry, eye It may include wireless or tethered sensors that measure motion, etc.

[0026] The computing device 304 may perform an open-loop It may be configured to provide control and / or closed-loop stimulation. With respect to the p-stimulation, the computing device may be configured to synchronize the patient's respiratory movements (e.g., each of the patient's breaths) with the patient's breathing movements. , and the stimulation may be applied during inspiration, for example. For open-loop stimulation, it is possible to track specific physiological data such as respiratory movements or inspiration. However, under such an “open loop” scenario, stimulation can be applied without But the computing device still regulates the stimulation, records the data, The information may be used to act on the information. One way in which the device can operate is by having a computing device configure parameters of the stimuli. Although stimulation can be applied in an open-loop manner, it is recommended that the system always operate in a closed-loop fashion. Monitor the patient's respiratory movements in a closed-room manner, working with algorithms to assess the data. The advantage of this is that you can know when to go back to applying stimulation on a breath-by-breath basis. Thus, adjustments to the stimulation may be based on input to the computing device 304. Often, this is achieved by measuring one or more of the physiological data recorded over time by one or more sensors 302. The treatment parameters of the system may be based on one or more trends in response to physiological data. Physiological data can be stored and examined over time to adjust treatment parameters automatically. For example, you can inspect the treatment data in real time and change the treatment parameters. You can make real-time changes to the data.

[0027] One or more electrodes 306 may deliver stimulation configured according to parameters. In this example, the sensing component 302 and the electrode 306 may be the same structure or element. Advantageously, a single structure or element may be used as the sensing component 302 and the electrode 306. The use of the system reduces the invasive nature of the surgical procedure associated with implantation of the system. While also reducing the number of foreign bodies introduced into the subject. The electrodes are disposed on the same device, such as a neuromodulation lead.

[0028] A computing device 30 programmed to implement a closed-loop scenario An example of the fourth embodiment is shown in FIG. 12. The computing device 304 includes a memory 422 (e.g., temporary memory), a processor 424 (e.g., a collection of application specific integrated circuits (ASICs) The memory may include a single integrated circuit (IC), or an ASIC that includes both a memory and a processor. For example, The memory 422 is a processor 424 that controls the system, apparatus, or device (computer). by or in response to the instruction or execution of a computer (e.g., computer operating device 304) Contains or stores machine-readable instructions (e.g., programs) for use in connection with The present invention may be implemented in a computer-usable or computer-readable medium. The computer usable or computer readable medium may be, for example, a static or dynamic medium. Random Access Memory (RAM), including RAM, Read-Only Memory (ROM), Flash Flash memory, erasable programmable read-only memory (EPROM), floating point memory, or a combination of these (including a combination of these on the same ASIC) The processor 424 may include, but is not limited to, one or more processing The memory 422 may include a core, a processing unit, etc. The processor 424 accesses the memory 422 and stores machine-readable instructions (e.g., one or more processor 3, which may include a program, to cause the computing device 304 to execute a monitoring component 42. 6, the operation of the identification component 427, and / or the classification component 428 may be performed. The processor 424 can decode the data, analyze the data, and generate patterns. The system can interpret physiological information coming from sensors, including recognizing signals.

[0029] The monitoring component 426 monitors the physiological data recorded by the sensor 302. The identification component 427 may identify trends in the physiological data (e.g., related to respiratory movements). For example, the monitoring component can monitor spike rate, amplitude, and EMG waveform characteristics such as frequency, as well as phasic and tonic activity can be monitored. (and monitor for changes in EMG amplitude, frequency, or other parameters) The identification component identifies triggers (e.g., changes in characteristics of the EMG waveform) during such monitoring. In one embodiment, the trigger may be a short-term contraction of the genioglossus muscle, indicative of phasic activity of the genioglossus muscle. contraction or genioglossus root observed over one or more portions or repetitions of physiological data There were associated changes in EMG, such as long-term changes in genioglossus activity indicating changes in sustained tone over time. The trigger may be a sleep-related condition, such as a change in physiological data of at least one parameter. may be identified as a biomarker for related conditions. In one embodiment, the biomarker may be inspiration. In another embodiment, the biomarker may be posture. In another example, the biomarker may be the stage of the sleep cycle ( Example: Awake, Non-REM Sleep - Stage 1 light sleep, Stage 2 light sleep, Stage 3 deep sleep In some instances, motion detection and / or other biomarkers may be used. The car is used to automatically activate therapy only after the patient falls asleep, eliminating unnecessary discomfort. without disturbing or disturbing the patient to increase patient comfort and adherence to therapy The stimulation timing was adjusted to optimally maintain airway patency throughout the night without waking events. parameters can be determined (adapting stimulation based on sleep stage and body position) Stimulation can be intensified as the patient moves from light to deep sleep. or the first pulse in the pulse train is smaller than the last pulse in the pulse train. The stimulation may be intensified during each stimulation step to have a different amplitude and / or pulse width. In some instances, stimulation is automatically stopped when the patient wakes up and falls asleep again. It will resume soon.

[0030] The awake stage of the sleep cycle begins when the subject first lies down on the floor or This refers to the relaxing stage when you relax and fall asleep again. The REM stage involves rapid eye movements and no eye contact. Your eyes may shift rapidly from side to side, your breathing may become more rapid and irregular, and your heart rate and blood pressure may drop to nearly waking levels. This includes REM sleep, in which the muscles in the arms and legs become temporarily paralyzed.

[0031] NREM stage 1 refers to the transition from wakefulness to sleep (lasting a few minutes). During this period, the subject's heartbeat, breathing, and eye movements slow, and their muscles occasionally twitch and relax. NREM stage 2 is the longest of all stages and is the deeper stage of sleep. This is the period of light sleep before and after sleep, during which the heartbeat and breathing slow down, muscles become more relaxed, and body temperature cools. NREM stage 3 is the deep sleep required for feeling refreshed in the morning. This refers to a period of sleep during which the heartbeat and breathing slow to their lowest levels and muscles relax. May have difficulty relaxing and waking up.

[0032] Sleep states can be determined, for example, by physiological data (e.g., EMG showing tonic activity of the genioglossus muscle). Once the sleep state is recognized, an informed decision can be made to minimize patient discomfort and Therapy should be applied in a manner that minimizes potential stimulus-related arousal events. This is achieved by reducing the amplitude of stimulation during stages 1 and 2 sleep, and stages 3 and This may include increased amplitude during stage 1 compared to stage 3 and REM sleep. and during stage 2 sleep, a longer period of therapy, meaning from 0 to the programmed output value. The technique may be strengthened for a longer period of time, or when applied during inspiration, e.g. This may include intensifying therapy within each pulse train.

[0033] For example, specific EMG changes, such as phasic changes in EMG activity indicative of inspiration during any given sleep phase, If activity is detected, the system can deliver stimulation during the respiratory effort phase of inspiration. The system provides therapeutic airway patency during inspiration, e.g., by using specific electrodes. Use the set, waveform, pulse width, frequency, interpulse interval, and pulse enhancement rate. Stimulation can be applied to the hypoglossal nerve. The system can stop stimulation during the expiration phase. It is possible to monitor physiological EMG, for example from the genioglossus, throughout the inspiratory and expiratory phases of each breath. The system can continuously monitor the stimulation parameters and / or the stimulation selections. Adjust selected electrodes as needed to optimize stimulation and adjust for additional factors including sleep state, body position, etc. Based on biomarkers, optimal airway patency can be provided. The closed-loop algorithm embedded within the neuromodulation lead is Continuously monitor and adjust therapy based on patient data and use rules-based classification to improve sleep How, when and for how long will it take to provide optimal airway patency during sleep? It can be determined whether stimulation is applied and adjusted.

[0034] For example, certain EMG activities, such as tonic and phasic EMG activity, decline during REM. or cease, the system will automatically restart the device based on predefined parameters programmed by the physician. Stimulation can be delivered periodically and the system can be tailored to previously known patient-specific parameters. Stimulation can be applied based on the data, or the system can be configured to apply stimulation throughout REM sleep. A default periodic stimulation can be applied. The system also Monitor EMG throughout the period to determine when to stop using regular stimulation, and A determination can be made when to resume applying stimulation during each inspiration event.

[0035] In some instances, the system directly stimulates the stimulator when it is within the electric field from the transmission coil. The system cannot immediately turn on stimulation. In this case, the system cannot understand the sleep stage. To do this, turn on and monitor the EMG signal, e.g. tonic and phasic muscle activity. It can detect when a patient is asleep and has entered sleep stage 1 or sleep stage 2. Once the system has determined this, the system 10 may then detect unwanted arousal events or Begin to deliver therapy in a physiological manner so that no pain or discomfort is caused. For example, start applying small amounts of stimulation using stimulation reinforcement during each stimulation period. In this configuration, EMG can be monitored for minutes or hours to allow the system to provide therapy. Before you begin, you can determine your condition. Many individuals with OSA also have a condition that causes them to have difficulty sleeping. You suffer from insomnia that you have a hard time falling asleep in, and in this case, you are in a negative feedback loop. This can lead to patients fearing that the therapy will be turned on before they fall asleep, and thus having difficulty falling asleep. This can cause further anxiety, such as not being able to relax enough to fall. This may cause an individual to turn off therapy or discontinue use of therapy over time. It is possible to recognize when a patient is asleep and apply therapy physiologically. The "smart" system increases adherence and efficacy of therapy. When REM stage 1 is recognized, for example, the system may select NREM stage 2, NREM stage 3, REM stage 4, REM stage 5, REM stage 6, REM stage 7, REM stage 8, REM stage 9, REM stage 10, REM stage 11, REM stage 12, REM stage 13, REM stage 14, REM stage 15, REM stage 16, REM stage 17, REM stage 1 It may start to recognize sleep, etc.

[0036] For example, an ASIC (an example of a processor 424) can control the application of therapy. For example, the ASIC may be configured to control custom algorithms. The embedded digital logic uses the information collected by the sensor to determine airway patency. To control the volume of air that can flow through the upper airway, also known as pulmonary circulation to provide optimal therapy for the individual by determining when, how much, and with which stimulation parameters The embedded digital logic may be configured to determine whether to The EMG activity, which may be known to the algorithm to correspond, typically, to inspiration and expiration, is The algorithm decodes EMG activity to detect the anterior musculature and and / or triggering stimulation of the hypoglossal nerve (including its distal branches), e.g., to open the airway. Thus, therapy can be linked, for example, to each breathing movement, each inspiration, and each expiration. Therefore, the therapy is based on embedded information about EMG features corresponding to respiratory movements. By using correlated knowledge, it is possible to provide all the information during each breath, e.g. Embedded logic can track body posture, jaw position, sleep state (e.g., REM, NREM), movement, and EM specific to the movement, movement, and other physiological parameters that can elucidate and optimize therapy The algorithm may include knowledge of the characteristics of G. To provide a better understanding of sleep patterns, we use adaptive learning to identify individual patterns that correlate with the above physiological states during sleep. It can learn the EMG characteristics specific to each individual patient. Adaptive learning is based on the physician’s input. This can be done manually by force or algorithmically based on given limits and knowledge. It can be done entirely in-house or with cloud databases and cloud software. The software can be used to analyze data from each patient and each sleep session. The algorithm uses additional adaptive learning to measure the EMG signals. It can also have different modes based on the information of respiratory motion detected by the This mode allows algorithms to run and deliver therapy on a breath-by-breath basis, especially during inspiration. In another mode, the algorithm can learn and generate the EMG-based It can also look for input from the user (e.g. patient, doctor, etc.). In this mode, the algorithm provides more continuous control of the airway and over a period of time. In another mode, the algorithm can provide periodic stimulation that can be sustained. Detects MG information but does not provide breath-by-breath therapy, instead predicting future airway collapse Wait until it is identified and respond by providing therapy to prevent collapse from occurring. EMG information includes EMG amplitude, EMG frequency content, spike detection, Envelope detection and control algorithms to balance respiratory movements and airway collapse Other features may be included that can be taken directly from the EMG signal to provide biomarkers. The algorithm may use any or all of these features throughout the entire sleep period. and switching between modes based on EMG activity sensed by the EMG sensor. or the system can be hardwired to run only one algorithm. It is understood that the memory can be hard programmed.

[0037] The system provides therapy in a manner that does not cause discomfort and / or awakening events to the patient. As the patient moves between stages throughout the night, the system detects sleep stages. It can be adapted continuously to the level (and / or needs of the patient). The greatest need for sleep occurs during deep sleep (non-REM stage 3), when discomfort and the likelihood of awakening is low. and REM, the system detects arousal and discomfort during these stages. More stimulation can be applied because the patient is less likely to wake up. You can also track the amount of time you spend waking up, which is why most OSA patients often spend their time awake. This is extremely useful for tracking outcomes as patients are unable to enter deep sleep due to the condition.

[0038] A classification component 428 applies rule-based classification to the trigger to determine whether one or more stimulation electrodes One or more stimulation parameters applied by the sleep-related biomarkers are then determined. As mentioned above, biomarkers can be used to determine whether they should be modified. Inspiratory phase (e.g., inspiration with periods within inspiration), sleep stages during one or more sleep cycles, and and / or during sleep as indicated by EMG or other sensors or sensed activity. The stimulation parameters include, for example, pulse width, amplitude, frequency, and waveform shape. , electrode location / configuration, etc.) based on the rules used by the algorithm. Initial rules for the class can be set for the patient and / or based on historical data for the population. based on the value of, historical values ​​for the patient, and / or patient-derived values The algorithm's subsequent rules are learned based on an artificial intelligence learning process. It may be learned and / or updated and / or personalized.

[0039] Feedback related to the stimulus (e.g., after the stimulus is delivered) is computed. The computing device 304 may provide the feed The feedback can be received and one or more stimulation parameters can be altered.

[0040] An exemplary closed-loop control scenario could involve sensing / recording physiological data over time. 3, with one or more sensors 302 (implanted adjacent to an anterior tongue muscle, such as the genioglossus muscle) Physiological data correlated with respiratory movements but not with sleep position, sleep state, and / or SD. of the anterior airway, which may also include characteristic signals that may correlate with other physiological characteristics important to the treatment of B. The computing device 304 may include one or more The physiological data recorded by the sensor 302 is monitored to detect trends in the physiological data. Triggers can be identified by the presence of sleep-related conditions (e.g., inspiration). Rules-based classification can be applied to triggers to identify biomarkers for Based on biomarkers (e.g., one or more electrodes 306, or electrode contact to the hypoglossal nerve), determining whether to modify one or more parameters of the stimulation (delivered by the can.

[0041] The change in voltage on the transmission receptor and the change in voltage on the power receiver, and the resulting The change in impedance generated by the power receptor is sensed to determine the position and movement of the power receptor within the magnetic field. In this embodiment, the voltage and impedance between the two coils of the power antenna can be measured. Changes in performance provide additional information to the system to inform the closed-loop algorithms, This type of position sensor can be used to measure the To potentially provide additional data about sleep quality over time, as well as health-related information , may have further utility beyond optimizing therapy. Furthermore, the impedance between the coils Data can be correlated with activity and track wake and sleep cycles compared to each other. These data can also be used to derive EMG data, e.g. These can be used together with sustained EMG activity to measure the duration of time spent attempting sleep (e.g., power reception) Compare wakefulness and sleep throughout (when the receiving coil is within the volume of the induction field of the transmitting coil). can be understood and learned.

[0042] Several wired or wireless applications, including smartphone or tablet applications Other input applications, such as wireless remote controls, can also be used. Additional input applications allow the closed loop algorithm to adjust therapy as needed. To adjust the rhythm, adjust the stimulation output, adjust the optimization, or An additional input can be provided to the system to adjust the rhythm mode. The application displays the user's EMG data and allows the user to select input filters, trigger amplitudes, and Allows you to adjust the parameters that control EMG acquisition, such as width, frequency range, etc. It is possible.

[0043] The input application can also enable automated therapy titration. In this mode, the application delivers stimulation to a target area on the subject, such as a target nerve or target muscle. Provides stimulation to the muscles, resulting in evoked EMG activity in muscles such as the anterior tongue, including the genioglossus. You can run custom software to monitor the behavior of the resulting EM G activity can be correlated to the desired amount of airway opening (entered into the application). This allows for automated therapy stimulation parameter setting, and time-consuming interventions during sleep. Non-limiting examples of stimulation parameter settings include: may include stimulation pulse width, amplitude, frequency, electrode position / configuration, etc. The system can determine the stimulation output of the therapy and allow the subject / physician to fine-tune as needed. The subject or physician may use the automated parameter adjustment application You can run the application again at any time and monitor it remotely through the application. This allows titration and programming to be done from the comfort of the patient's home. It is possible to do so.

[0044] The resulting evoked EMG signal can be continuously monitored and analyzed for a given stimulation parameter. Even if the response to a set of data changes over time, the tongue response required for effective treatment Determine the stimulation parameters required to generate movement and the initial programming required This can effectively reduce the amount of unnecessary testing and the need for ongoing follow-up testing. Also, there may be issues with the therapy (e.g., whether stimulation with a particular stimulation parameter setting opens the airway). and can identify patients and / or An alert can be generated for the physician (this allows for a quick response and (This allows for proactive management.)

[0045] Another aspect of the present disclosure is a method for treating SDB by neurostimulation using a closed-loop algorithm. and / or a method 700 for providing muscle stimulation (FIG. 13). may be performed by components of the system, for example as described and shown in the figures. Portions of the method 700 may be at least partially stored on a non-transitory memory, It may be executed by a processor.

[0046] For simplicity, the method 700 is shown and described as being performed sequentially. However, some steps may be performed in a different order and / or with respect to other steps shown and described herein. It is understood that the present disclosure is not limited by the order illustrated, as the steps may be performed simultaneously. Moreover, not all illustrated aspects may be required to implement method 700. and / or may require more than the illustrated aspects to implement method 700. Additionally, one or more aspects of the method 700 may include storing the data in one or more non-transitory memory devices. It may be stored and executed by one or more hardware processors.

[0047] In the 752, the suction force recorded by one or more sensors (e.g., EMG-indicated suction force) You can monitor physiological data (related to your sleep, mood, sleep stages, and / or body position) One or more sensors may be placed, for example, adjacent to an anterior tongue muscle, such as the genioglossus, or adjacent to the genioglossus and genioglossus muscles. The 754 can be implanted in the plane between the bone and the muscle. Triggers can be identified by (e.g., during respiratory movement as indicated by EMG) At least one of the physiological data (indicating inspiration, posture, and / or stage of the sleep cycle) The change can be in one parameter.

[0048] At 756, applying a rule-based classification to the trigger to identify the biomarkers represented by the trigger. Based on the sensor, it is possible to determine whether one or more parameters of the stimulus should be modified. For example, a signal containing configuration / setting information for parameters can be sent to a device located adjacent to the hypoglossal nerve. The stimulation parameters can be adjusted to optimize airway muscle tone. The therapeutic approach can be titrated and adapted based on triggers to optimize the therapeutic effect.

[0049] Stimulator configuration The stimulator will be tailored to the specific therapy being applied and / or the location where the stimulation therapy is being applied. The stimulator 20 may have a variety of configurations that may be tailored to the anatomical structure. The stimulator 20 includes a power receiver 30, an electronics package 50, and a stimulator. The power receiver 30 may include a stimulator lead 80. The power receiver 30 is packaged in a protective biocompatible material. The electronics package 50 and electronic components are packaged and mounted within the The antenna 32 may include a coiled receiver antenna 32 operably connected to the element 52 .

[0050] The stimulator lead 80 is also operatively connected to the electronics package 50 which controls the operation of the electrodes 82. In an exemplary configuration of the present disclosure, the stimulator 20 is connected to an electronics package 50. Extending from the stimulator lead 80 may facilitate connection to the electronics package. The pigtail connector 54 is adapted to accommodate leads of different configurations. The electronics package 50 and the stimulator link are connected to the electronics package 50. This allows for a severable connection between the stimulator lead 80 and the This may also facilitate the manufacture of a respirator having a desired size and / or configuration. It may be possible to select the mode.

[0051] Additionally, a stimulator lead 80 is connected to the remainder of the stimulator 20 via a pigtail connector 54. and can be connected to the remainder of the stimulator 20, thereby allowing the lead to be separated As a result, implantation of the lead 80 can be performed without invasive procedures. This can make the lead less invasive and allow for placement through smaller incisions. The surgeon then removes the remaining parts of the stimulator 20, such as the electronics package 50 and antenna. 32" for working with larger incisions, etc. Also, the need to handle and operate the entire stimulator 20 as a whole during the implantation process is necessary. , which can complicate lead placement.

[0052] The stimulator lead 80 may be generally elongated, with spaced apart electrodes along the length of the lead. The electrode 82 is shown generally at 84 in FIG. 2, which may be electrically connected to the electronics package 50 by a conductor such as a wire. In the exemplary configuration shown, the stimulator 20 has an eight-channel, eight-electrode configuration, which is The stimulator lead 80 includes eight electrodes 82, each with its own dedicated channel. The stimulator 20 may be configured to have more or fewer channels. Additionally or alternatively, the stimulator 20 may also be configured to Or, depending on the targeted anatomy, it may contain two or more leads. Regardless of the number of channels, each electrode 82 can be configured and utilized independently of the other electrodes. Therefore, whichever of the electrodes 82 is determined to be most effective for a particular implementation is All or some of the above may be utilized during the application of the stimulation therapy.

[0053] Electrode 82 may be utilized as a stimulating electrode or a sensing electrode. A stimulating electrode may be, for example, a nerve or muscles. For example, detecting and measuring EMG responses from neuromuscular structures associated with a target nerve For the implementation of SDB treatment illustrated in this description, The meridian may be the HGN and the associated muscle may be the genioglossus. The device can be used to target other nerves and obtain other solutions, such as EMG responses, from other neuromuscular structures. It can be used to measure physiological electrical signals from anatomical structures.

[0054] In the exemplary configuration of FIG. 2, the electrodes 82 are four spaced along the length of the lead 80. One group of electrodes 82 is arranged in a lead. 80 and one group can be located distally near the end of the distal group. However, the electrode 8 may be positioned proximally between the electronics package 50. The configuration of the two may vary. The stimulator may include a different number of electrodes (two or more) and / or or electrodes may be grouped, spaced, or otherwise arranged in different configurations along the length of the lead. As previously mentioned, the stimulator may also be configured with any suitable number of leads (one or more). It may include.

[0055] The identity of electrodes 82 as stimulating or sensing electrodes is determined by whether these electrodes are electronic This may be determined by a method controlled via the power package 50. The IDs of the electrodes 82 may be fixed. In fixed implementations, the IDs of the electrodes 82 may be One electrode can be exclusively assigned to be used as a stimulating electrode, and the other electrodes can be used as a sensing electrode. In another implementation, the ID of electrode 82 can be assigned to and used exclusively as a pole. In a dynamic implementation, the electrodes 82 are both stimulating and sensing electrodes. In a further implementation, the electrodes 82 may be assigned a fixed ID and a variable ID. It may be implemented in combination with ID.

[0056] How the electrodes are utilized will depend at least in part on how the stimulator itself is implemented. In part, it depends on the particular implementation of the stimulator. Both the application of stimulation energy and the detection of EMG responses or other physiological electrical signals It can be positioned relative to structures such as nerves and / or muscles as desired. In these cases, some or all of the electrodes may be placed in a position where stimulation is desired at the electrode location. as a stimulating electrode when stimulation is required, and as a sensing electrode when sensing is desired at the electrode location. In other implementations of the stimulator, some electrodes may be configured such that only the application of stimulation energy is required. Other electrodes can be positioned relative to the desired structure to measure EMG responses or other physiological The probe can be positioned relative to a structure where only detection of a target signal is desired.

[0057] Advantageously, the identity of the electrode 82 is configured in the software settings and not in the hardware configuration. The optional configuration of electrodes 82 may be implemented using an electronic device package 50 that is encapsulated within the electronic device package 50. This can be facilitated by electronic component 52. Electronic component 52 is preferably However, electronic component 52 is implemented in an application specific integrated circuit (ASIC). One or more ASICs, discrete electronic components, and electronic components integrated into the power receiver 30 and and / or an electrical connector for connecting to an electrode lead 80. The electronic components include: Whether embodied in a single ASIC or in one or more components, e.g. , processing components and memory components (e.g., microcomputers or computer operating systems) a charge storage device (e.g., a capacitor) to store charge and provide stimulation power Select the ID of the electrode (e.g. anode, cathode, recording electrode) and the current supplied to the electrode. A solid-state switching device for modulating the power (e.g., pulse width modulation (PWM ) switch).

[0058] To provide comfort to the patient and ease of insertion by the physician, the stimulator 20 is generally soft. The soft / flexible construction may include the leads 80, the power receiver 30, and the , or to both the lead and the power receiver. In one exemplary configuration The stimulator components (power receiver 30, electronics package 50, and leads 80) have used biocompatible materials such as silicone, epoxy, and a variety of suitable polymers. They may be simultaneously coated or otherwise encapsulated in a single operation, such as by insert molding.

[0059] 4-6, the power receiver 30 and / or the lead 80 may be The structure may have a flexible configuration that allows it to bend or flex, which may be achieved by a variety of The power receiver 30 is generally flat and planar, facilitating implant compatibility with a wide variety of anatomical structures. It may have a planar configuration, and as shown in FIGS. 4 to 6, the power receiving portion may be arranged in the XY plane. The bending can be performed in a direction transverse to the plane of the machine 30. Thus, the broken line at 30' in the figure As shown in FIG. 4 to FIG. 6, the power receiver 30 can be bent in the Z direction. As shown, the lead 80 may be of a generally elongated configuration and extends axially along the X-axis. The lead 80 may extend in multiple directions relative to the plane of the lead, i.e., in the direction of 80' in the figure. As shown by the lines, it can be bent in one or both of the Y and Z directions. This can be done.

[0060] To facilitate flexible construction of the lead 80, the electrode 82 and the electrode are attached to the electronics package. Conductors 84 (see FIG. 2) that connect to the cage 50 may be contained and supported within a cover 86. The cover 86 is formed from a biocompatible material, such as silicone and various suitable polymers. The cover 86 may be configured to leave the electrode 82 or a portion thereof exposed. , for example, may be formed within the aforementioned insert molded cover of the stimulator 20 structure.

[0061] To facilitate flexible construction of the power receiver 30, the antenna 32 is flexible and and may be formed on a soft substrate to conform to the anatomy of the implant site. For example, the power receiver 30 may include an antenna 32 that is constructed from a flexible material such as a polymer. A flexible plate is etched from a thin layer of conductive metal deposited on the substrate 38 (see FIG. 3). In one particular flexible PCB construction, the substrate is The material may be a polyimide material and the conductive metal may be copper. The antenna 32 is contained and supported within the cover 48. The cover 48 may be made of a biocompatible material such as silicone, epoxy, and various suitable polymers. The cover 48 may be formed of a suitable material, for example, the insert 26, which is configured to cover the entire structure of the stimulator 20. It may be formed in a molded cover.

[0062] The flexible PCB of the power receiver 30 may extend into the electronics package 50 and may be attached to the electronic structure. The PCB may also be configured to connect conductors 84 of leads 80 to the PCB. and / or may be configured to form part of the lead itself. The device 30, electronics package 50, and leads 80 (or portions thereof) are biocompatible. simultaneously encapsulated in a viscoelastic material (e.g., silicone, epoxy, and various suitable polymers) obtain.

[0063] While flexible, the leads can also be configured to maintain the shape to which they are formed. This feature is achieved, for example, by conductors 84 connecting electrodes 82 to electronics package 50. or additional internal shape-maintaining (e.g., metal) support structure extending along the length of electrode 82. (not shown). In either case, the metal conductor 84 or the support structure allows the lead to be manipulated three-dimensionally (3D) into a desired shape; or It is possible to have a predetermined via and, once formed, the shape or via They may be selected to possess physical properties such as malleability / ductility, maintaining their inherent mechanical properties, and For example, the leads may be configured differently, for example, by heat forming, material forming, or By using other methods of manufacturing biased leads, It can be biased to have a particular shape.

[0064] 7 and 8 illustrate one such 3D shape in which the lead 80 may be formed. The exemplary configurations of FIGS. 7 and 8 may include additional or alternative bend depths, as shown in FIG. 7. In the vertical direction, the generally U-shaped or omega-shaped three-dimensional 3 shows a lead 80 formed in a 3D configuration. This particular 3D configuration includes electrodes at different locations along the HGN. 82, for example, the stimulator may be implemented to treat SDB, such as OSA. More specifically, the lead 80 in FIG. 7 and FIG. 8 is configured as follows: The right and left electrodes 82 (as viewed in the figure) should be placed very close to the bifurcations of the HGN. The right and left electrodes 82 in the implanted configuration can be Extends along the posterior-anterior course at or near the site of a branching point, such as a distal branching point from the main trunk. This arrangement allows for the placement of electrodes close to the single branch required for posterior airway control. In particular, in one embodiment, the neuromodulatory link can be directly electrically activated. The lead comprises a lead body having a left portion, a right portion, and a middle portion 81 therebetween. The neuromodulation lead includes a left set of electrodes 82 disposed on the left portion of the lead body and a and a right set of electrodes 82 disposed on the right portion of the head body. At least one of the plurality of electrodes is adapted to deliver a stimulation signal to a target site. The lead body is the stimulation electrode that is configured when the neuromodulation lead is fully deployed. Qualitatively biased towards an omega shape and / or the mid-portion of the lead body 8 1 is the inferior to the left and right sets of electrodes 82 when the neuromodulation lead is fully deployed The electrodes on the left and right portions of the lead body are biased toward the The location of the left and right sets of poles are the hypoglossal nerve trunk, the lingual nerve trunk, and the lingual nerve trunk when the neuromodulation leads are fully deployed. The distal branch of the inferior nerve, the branch that innervates the horizontal fibers in the genioglossus, and the oblique fibers in the genioglossus. each of the left and right, including the nerve branches it innervates, or any suitable combination thereof The stimulation target site may be based on the location of the stimulation target site.

[0065] Additionally, with this implementation of the lead 80, the neurostimulation system 10 eliminates the need for surrounding structures. Stimulate bilaterally or unilaterally as needed, without unwanted or undesired stimulation The 3D biased nature of the lead 80 and the fact that the anterior tongue muscle Due to the synchronous way in which it moves, additional anchor structures may not be necessary. The downward bending of the lead at the intermediate portion 81 allows the genioglossus muscle to better interface with the electrode set and the genioglossus muscle. The leads have a convex shape (when viewed from below) to allow for good contact. This may enable the genioglossus muscle to be exerted with force.

[0066] The power receiver is designed to deliver maximum power to the stimulator from a given external magnetic field. With this goal in mind, exemplary configurations of HGN stimulation disclosed herein are In this implementation, the power receiver 30 and the receiving antenna 32 are connected to several base stations of the stimulator 20. It has a unique structure designed to comply with the standards. The standards are, of course, the purpose of the system. Dependent on the intended therapeutic use and the resulting composition. The criteria for this are to develop a system for treating SDB, including OSA, via neuromodulation of HGN. 10 exemplary configurations. The stimulator 20 is a magnetic stimulation device as recommended in IEEE standard C95.1-2005 (Reference 3). Operates within guidelines regarding maximum permissible exposure to the field. The receiving antenna 32 receives nearly continuous power consumption (10-30 milliwatts) from the stimulator 20. (mW) The receiving antenna is designed to operate in the industrial, industrial and commercial radio frequency (ISM) spectrum from 100 kHz to 2.4 GHz. It operates at frequencies in the range of 6.78M, 7.8M, 10.2 ... Frequencies of 13.56 Hz or 13.56 MHz were used. The receiving antenna 32 has a diameter of 2-3 cm and is as thin as possible to maintain flexibility. stomach. The stimulator 20 is small enough for minimally invasive subcutaneous implantation in the soft tissue of the submandibular gland. The stimulator 20 is soft and flexible so that it can be manipulated to fit the patient's anatomy. Maintain gender design. Other stimulation therapies or implementations of the implantable stimulation system 10 may comply with some or all of these standards. Any or all of the criteria may be modified or adjusted, and certain criteria may be added or removed.

[0067] To meet these criteria, the receive antenna 32 is constructed in a double-layered, flat "pancake" configuration. Referring to FIG. 3, antenna 32 may have a first or upper / top antenna component. A first or upper / top side of the substrate 38 is formed with a second or lower / bottom side. A flexible PCB construction in which the antenna coil 36 is formed on the second or lower / bottom side of the substrate. The substrate 38 may be a thin (e.g., 1-3 mil) polyimide layer, and the coil 34, 36 are thin layers of copper or gold deposited on a substrate 38

number

[0068] The PCB 38 may also support electronic components 52 within the electronics package 50. Guidelines for maximum permissible exposure to )Using IEEE standard C95.1-2005, the maximum achievable delivered power is 6.7 These power requirements are approximately 10 to 30 mW at 8 MHz frequency. The estimated requirements for the 50 components, 52 estimated maximum stimulation parameters, and preclinical studies The MOSFET was selected based on the results of the previous study, while the MOSFET was selected to enable capacitor charging and provide transient power. A safety factor of 100% was also included. Transient power was generated by capacitors, supercapacitors, and ultracapacitors. through various components such as capacitors, or even through a rechargeable power source such as a battery. During patient exercise, among other things, upper limits on power ratios and / or coupling may be provided. Continuous power when the power supply is not ideal. Transient power can be used during stimulation, even while the patient is moving. Helps ensure full and continuous operation of the Gekiki 20.

[0069] Those skilled in the art will appreciate that during operation, the antenna is electrically connected to the coils 34 and 36 as well as to the individual coils. May be susceptible to power losses due to substrate losses and parasitic capacitance during turnaround. It will be appreciated that substrate losses are caused by eddy currents in the substrate due to the non-zero resistance of the substrate material. Parasitic capacitance occurs when these adjacent components are at different voltages and are stored. Every circuit element has this internal capacitance, which is , may cause the behavior of the circuit elements to deviate from the behavior of "ideal" circuit elements.

[0070] Advantageously, the antenna 32 is a unique dual-phase coil arrangement in which the coils 34, 36 are arranged in parallel. A layered pancake style coil configuration can be implemented. As a result, coil 34 , 36 generate equal or substantially equal induced voltage potentials when subjected to an electromagnetic field. This may be useful for equalizing the voltages in the coils 34, 36 during use. It has been shown that this significantly reduces the parasitic capacitance of the antenna 32. In the parallel coil configuration, the top coil 34 and the bottom coil 36 are shorted together within each turn. This design preserves the advantage of the lower series resistance of the two-layer design while at the same time reducing the It has been found to significantly reduce raw capacitance and produce high maximum power output.

[0071] This improved parallel configuration of the antenna 32 includes a top coil 34 and a bottom coil 36 on a PCB substrate 38. 9A and 9B, which respectively illustrate the lower coil 36. 4, 36 may include a plurality of coil windings or turns 40 and may be characterized by the following properties: The number of turns (N), outer diameter (OD), coil pitch (P), trace width ( W), trace thickness (T), and coil spacing (S). These properties are measured as follows: will be done. OD is measured across the coil between the outside edges of the outermost turns 40 and 3 4, 36 in diameter. The coil pitch P is measured between any two adjacent turns, between turns 40 is the interval. Coil width W is the width of each coil turn 40. The trace thickness T is determined by the thickness of the conductive (Cu) layer deposited on the substrate 38 of the PCB construction. The thickness of the turn 40 is determined by the The coil spacing S is determined by the thickness of the substrate 38 of the PCB construction. The distance between 6 and

[0072] In one particular configuration of antenna 32, the PCB substrate 38 is a 2 mil polyimide layer. The coils 34, 36 are etched from 1.4 mil copper laminated onto a substrate. The parallel coil configuration of the antenna 32 electrically couples the turns 40 of the coils 34, 36 through a substrate 38. These connections are illustrated at 42 in Figures 9A and 9B. For example, the connectors 42 between the turns 40 may be in the form of conductive connectors. Through the B structure, for example, the substrate 38 and the turns of the upper and lower coils 34, 36 40, holes are drilled or laser etched through the turn of the opposite surface of the substrate. For example, plated copper / gold or molten and / or flowable The holes may be formed by plating or filling them with a metal such as lead-tin. The connectors may also be formed mechanically, for example with pins or rivets.

[0073] The coils 34, 36 of the antenna 32 have a unique configuration that allows for their parallel interconnection. On each side of the antenna 32, the turns 40 are semicircular and each are closely spaced apart. The diameter of the turn is fixed with a curved end. This means that the diameter of the turn increases gradually from the outside to the inside. This is as opposed to conventional coil configurations, where the coil changes continuously in a gradually decreasing spiral. To create the 32 coiled configuration, one side of the antenna (the exemplary configuration of FIG. 9A) In this configuration, the links 44 are disposed between adjacent turns 40 of the upper coil 34 at the side of the upper coil 34. The link 44 may extend diagonally from the substrate 38, for example, as a portion of a copper layer laminated on the substrate 38. Thus, the upper coil can be formed as one continuous conductive (Cu) strip. 3. The upper coil 34 may be formed coextensive with the turns 40 of the upper coil 34. may be configured as a continuous coil having a decreasing diameter from the outside to the inside, thus , it can function as a coil configured in a spiral shape.

[0074] On the side of the lower coil 36 of the antenna 32, the turns 40 may also be semicircular. , each having a fixed diameter with closely spaced ends. There may be no link connecting the turns 40 of the antenna 32. Instead, Terminals 46 may be formed on the sides of the coil 36, one on the innermost of the lower coil. one connected to the terminal end of the outermost turn of the lower coil, and one connected to the terminal end of the outermost turn of the lower coil. A terminal 46 may be connected to the innermost turn 40 and may be disposed within the space between the ends of the remaining turns. It may extend to.

[0075] 9A and 9B, the turns 40 of the upper and lower coils 34, 36 are Through the connectors 42, adjacent coils of the upper coil 34 can be interconnected. The links 44 interconnecting the turns 40 interconnect adjacent turns of the lower coil 36. Thus, the turns 40 of the lower coil 36 are connected to the connector 42 and the ring The coils 36 may be arranged in a continuous coil configuration through the coil 44. may be configured as a continuous coil having a decreasing diameter from the outside to the inside, thus , it can function as a coil configured in a spiral shape.

[0076] The terminals 46 are electrically connected to both the upper coil 34 and the lower coil 36 through the connector 42. The terminal ends from which the terminals 46 extend may be inwardly connected. and radially opposite ends of the outer turn 40. As shown, The terminal 46 of the innermost turn 40 is connected to the terminal 46 on a first side of the space between the opposing ends of the turns. The terminals of the outermost turn 40 are connected to the first end of the turn while the terminals of the outermost turn 40 are connected to the opposite end of the turn. Connected to opposing second ends of the turns on opposing second sides of the space between the ends.

[0077] For the configuration illustrated in Figures 9A and 9B, the performance of the antenna is in accordance with the properties listed above. Exemplary configurations of antennas that adjust for some of these properties were tested. These exemplary configurations are described in the table below. [Table 1]

[0078] As shown in the table above, the maximum delivered power provided by each exemplary coil configuration is: Even with the reduced coil outer diameter of Example 4, the power requirement of 10 to 30 mW is met or exceeded. Or beyond that.

[0079] The external controller 100 has two components: a power mat 110 and a bedside The control unit 120 may, for example, be powered by a wire. The mat 110 may be connected to the bedside table 110, for example, so that it can be placed on a nightstand. The control unit is designed to include a user interface, e.g., buttons, knobs, tabs, etc. By including a touch screen, the user can use the system in bed. The power mat 110 can be used to control the operation of the system. The mattress may be designed to be placed on a sleep surface such as a mattress pad, and thus may be used as a pad, e.g. For example, the electrode may be configured to have a thin, flat, soft, flexible, and slip-resistant configuration. The force mat 110 comprises one or more non-magnetic members disposed in or on a flexible or semi-flexible surface 114. The power mat 110 supports a line power transmission coil 112. The power mat 110 has a bottom edge 116 of the mat. The power supply may be positioned on the sleep surface to correspond approximately to the position of the patient's shoulders while sleeping. The shape and size of the pillow 110 may vary depending on the shape and size of the pillow, e.g., a queen size pillow. It can respond to the noise.

[0080] The control unit 120 can excite the power transmission coil 112 to generate an electromagnetic field. The external controller 100 can use the transmission coil 112 in the power mat 110 to By receiving the antenna 32 via electromagnetic induction, the tethered wireless When the patient is in a sleep position on the sleep surface, the stimulation The antenna 32 of the device 20 receives the electromagnetic waves generated by the transmission coil 112 of the power mat 110. The shape of the electric field can be used to power the stimulator 20 through various sleep positions. The coil 112 is tailored through its configuration to provide an electric field optimized for For example, the electric field extends horizontally (as viewed in FIGS. 10A-C) between the coils 112. The stimulator 20 may be configured so that it is positioned within the vertical boundaries of a horizontally extending electric field. It can be powered whenever it is attached.

[0081] Through induction, a current is induced in the receiving antenna 32, which is then passed to the stimulator electronics power supply. The component 52 in the electronics package 50 may be provided with an electrode 82. Through this movement, the electrodes 82 apply electrical stimulation to the nerves or muscles. as a stimulating electrode for, e.g., detecting neuromuscular responses to the application of electrical stimulation; For example, as EMG sensing electrodes or as stimulation electrodes and at different times during the application of stimulation therapy. The electrode can be used both as a sensing electrode and as a counter electrode.

[0082] In addition to providing power to the stimulator 20, the external controller 100 also controls A data link may be provided to facilitate two-way communication between the controller and the stimulator. While powering the electrodes, the controller 100 simultaneously controls the electrode assignment and stimulation parameters. To provide a wireless data signal that is used to program the stimulator with settings such as and also to measure triggered stimulation events, measured EMG responses or other electrical events. The physical signal, the current value, the electrode impedance, and the controller 100 and the stimulator 20 Retrieving stored data from the stimulator, such as data related to wireless power transfer during It is also possible.

[0083] Additionally, the stimulator 20 may be configured to calculate the power delivered to the stimulator. The impedance and / or voltage of the antenna 32 of the device can be monitored. , can be provided as feedback to the controller 100, so that the controller , the current supplied to the power transfer coil 112 can be adjusted. can control the power delivered to the stimulator to stay within the standards / requirements mentioned above. At the same time, the feedback ensures proper power delivery to the stimulator 20, again within prescribed limits. It is easy to increase the current supplied to the power transmission coil 112 so that In this manner, the controller 100 implements closed loop control to The power supplied to the stimulator 20 may be optimized.

[0084] The operation of the controller 100 allows a user, e.g., a patient, a physician, or other caregiver, to A user interface that allows control of aspects of the operation of the implantable stimulation system 10. The control may be performed, for example, by a user of the control unit 120. A user interface or a patient using the patient user interface 200 Even if the device is controlled by a local computer, remote control by a doctor via the Internet / Cloud 208 is possible. The control unit 120 may have a small footprint and may be power The mat 110 allows the external controller 100 to be small, discreet, and portable for travel. It may be flexible in design so as to

[0085] Power mat configuration To account for changing sleep positions throughout the night, the power mat 110 tracks the patient's movements. The stimulator 20 has a large enough footprint to accommodate At the same time, the external controller 100 can maintain the ability to transmit force. Regarding the maximum permissible exposure to magnetic fields recommended in E standard C95.1-2005 (Reference 3), The device produces electromagnetic radiation at levels that fall outside the guidelines set forth in this section.

[0086] Exemplary transmission coil configurations that may be implemented in the power mat 110 are shown in FIGS. 10A-10C. These example transmission coil configurations can be implemented in a flex circuit design. That is, the coil is made of a conductive metal (e.g., polyimide) laminated on a flexible substrate. The examples of Figures 10A-10C are formed (e.g., etched) from a conductive material. The general shape of the transmit coil 112 is illustrated without showing the individual turns of the transmit coil. This depends on the properties of the transmission coil 112, e.g., number of turns, coil pitch / spacing, trace width, etc. are not limited to what may be the case for the coils 34, 36 of the antenna 32. The antenna coils 34, 36 are arranged to fit within the small footprint of the antenna 32 of the stimulator 20. The power mat 110 can be specifically tailored for maximum inductive power generation due to the limitations of In comparison, the transmission coil 112 may be larger and is compliant with the aforementioned IEEE Magnetic Field Exposure Guide Generate a magnetic field that can only be limited by the required level in the line It can be freely configured as follows.

[0087] Thus, the transmission coil 112 is magnetically coupled to the patient to allow for changes in position during sleep. The field may be configured to maximize the space or volume it covers. This can be achieved by varying The system may be endowed with the ability to continuously power the stimulator depending on the sleep position. FIG. 10A illustrates an exemplary twelve coil configuration of the transmission coil 112, and FIG. 10B illustrates an exemplary twelve coil configuration of the transmission coil 112. FIG. 10C shows an exemplary two coil configuration of the transmission coil. For all of these exemplary configurations, experimental testing has demonstrated that the transmission coil 112 meets the power requirements of this system within the IEEE exposure guidelines. While it is possible to achieve this, it has been found to be sufficient to cover the patient during normal sleep cycles. The antenna 32 is fitted with a consistent 32×76×25 cm (L×W×H) effective volume. It has been shown that this enables efficient power transfer.

[0088] The twelve coil configuration of the transmission coil 112 of FIG. 10A is generated by the power mat 110. This allows for dynamic control of the magnetic field generated by the stimulator 20. Through data coupling and communication, which coils in the 12-coil configuration are connected to the external controller and Through this determination, it is possible to determine whether or not a power connection between the external The power mat 110 is connected to the power controller 100. The power mat 110 is connected to the power controller 100. Only those coils necessary to power the machine 20 can be powered. If the subject changes position, the stimulator may trigger a reassessment and selection of a different coil. Any reduction in power transfer can be detected. This configuration therefore In order to maximize the electromagnetic field generated by the power mat 110 within the area of ​​the antenna 32, It can self-adjust on the fly.

[0089] The two coil configuration of the transmission coil 112 of FIG. 10B is a continuous coil around the power mat 110. Alternatively, the coil may be a static power coil that generates a constant electromagnetic field. This configuration provides the largest possible volume of power. The strength of the magnetic field can be adjusted to maximize power delivery to a wide range of patient positions. The entire position is maximized.

[0090] In both the exemplary configurations of FIG. 10A and FIG. 10B, the power mat 110 may be, for example, a soft A transmission coil 11 is housed in a flexible cover such as a flexible plastic, rubber, cloth, etc. The transmission coil 112 may have a flexible construction that is facilitated by the flexible circuit construction of the two. For example, the antenna 32 of the stimulator 20 may have a flexible PCB construction similar to that of the antenna 32 of the stimulator 20. The transmission coil 112 is etched from a polyimide, e.g., copper, laminated onto a substrate. The board may be constructed as a single layer flexible PCB with conductive traces.

[0091] Each of the disclosed aspects and embodiments of the present disclosure is intended to be illustrative, not restrictive, and not limiting of the scope of the present disclosure. The above and variations may be considered separately or in combination. Certain features of the embodiments may be shown only in certain figures or may be otherwise described in certain parts of the disclosure. However, such features may be different from other embodiments shown in other figures or in other parts of this disclosure. Similarly, the embodiments and aspects shown in certain figures of the present disclosure or Certain features of the embodiments and aspects of the present disclosure that are described in certain parts of the disclosure may be used interchangeably. may be omitted from such embodiments and aspects. When a range is stated, all points within that range are included in the present disclosure. All references cited in are incorporated herein by reference in their entirety.

Claims

1. 1. A neuromodulation device, comprising:

1. A neuromodulation lead, comprising: a lead body having a right portion, a left portion, and a middle portion; a left section of a plurality of electrodes disposed on the left portion of the lead body; a right set of electrodes disposed on the right portion of the lead body, At least one of the plurality of electrodes is configured to deliver a stimulation signal to a target site. a stimulation electrode disposed within the neuromodulation lead body when the neuromodulation lead is fully deployed; , biased toward a substantially omega shape, and / or said neuromodulation lead When fully deployed, the intermediate portion of the lead body contacts the left and right sets of electrodes. and biasing the right set of electrodes toward a lower position. a neuromodulation device including a neuromodulation lead comprising an electrode; an antenna configured to generate an induced current in response to being placed in an electromagnetic field; operatively coupled to the neuromodulation lead formed thereon and electrically connected in parallel with each other; an antenna having an upper coil and a lower coil; an electronic device comprising electrical components for controlling application of a stimulation signal through said stimulation electrodes; The equipment package and An external controller, the external controller comprising a control unit and the neural network. generating an electromagnetic field for inducing a current in said antenna to power the modulation lead; a power mat supporting one or more power transmission coils that are excitable such that An external controller; The device is configured to be implantable adjacent to the anterior tongue muscle and to record physiological data. A sensor configured as follows: a computing device, the computing device comprising: a non-transitory memory for storing instructions; and a processor, the processor accessing the non-transient memory and Execute the above command, monitoring the physiological data recorded by the sensor; identifying a trigger in the physiological data, the trigger being related to sleep; Identifying, identifying, and A rule-based classification is applied to the trigger to determine one or more parameters of the stimulation signal. determining whether to modify the data based on the biomarkers; The stimulation electrodes deliver the stimulation signal to the target site for a period of time, and the the one or more parameters of the stimulus signal in response to a signal from a computing device. A neuromodulation system configured to modify

2. The neuromodulation system of claim 1 , wherein the target site is the hypoglossal nerve.

3. the locations of the left and right sets of electrodes on the respective left and right portions of the lead body; However, when the neuromodulation lead is fully deployed, the hypoglossal nerve trunk, the distal hypoglossal nerve A nerve branch innervating the horizontal fibers in the genioglossus muscle, a nerve branch innervating the oblique fibers in the genioglossus muscle each of the left and right stimulations, including the nerve branches that serve the The neuromodulation system of claim 1 based on the location of the target site.

4. The electronics package is located on the neuromodulation device, and the antenna is located on the configured to provide a current to the electronics package to power the electronics package; The neuromodulation system of claim 1 .

5. and a user interface configured to communicate with the neuromodulation device. whereby operation of the neuromodulation device is controlled via the user interface. , which can be at least partially controlled.

6. The antenna comprises a substrate having an upper surface and a lower surface, and the upper coil comprises: a plurality of coil turns disposed on the top surface of the substrate, the lower coil comprising: a plurality of coil turns disposed on the lower surface of the substrate, the upper coil and 2. The neuromodulation system of claim 1, wherein the first coil and the second coil are electrically connected in parallel with each other. Tem.

7. The antenna is constructed from a flexible circuit board, and the upper coil and the lower coil is etched from a conductive layer on the substrate, and the electronics package is attached to the flexible circuit board. one or more electronic components mounted on a portion of a flexible circuit board; a plate configured to electrically connect the one or more electronic components to the antenna; The neuromodulation system of claim 6 .

8. The antenna extends through the substrate and electrically connects the upper coil to the lower coil. The neuromodulation system of claim 6, further comprising a plurality of connectors for connecting to:

9. The upper coil and the lower coil are positioned with overlapping coil turns. and the connector is configured to connect the upper coil and the lower coil to each other.

9. The method of claim 8, further comprising the steps of: connecting overlapping coil turns of the first coil and the second coil; Neuromodulation system.

10. The sensor is an EMG sensing electrode, and the plurality of electrodes are disposed on the neuromodulation lead. The neuromodulation system of claim 1 , wherein the neuromodulation system is at least one of the electrodes.

11. The neuromodulation system of claim 1 , wherein the rule-based classification is adaptive.

12. The physiological data may include phasic activity of the genioglossus muscle, tonic activity of the genioglossus muscle, or The system of claim 1 including both of these.

13. 2. The method of claim 1, wherein the physiological data is obtained from EMG activity by the anterior airway musculature. The system described in

14. The physiological data may include respiratory movements, sleep position during sleep, sleep state, or a combination thereof.

2. The system of claim 1, wherein the EMG characteristic signal is correlated to the phasic pressure.

15. the trigger comprises a change in at least one parameter of the physiological data. Item 2. The system described in item 1.

16. The system of claim 1 , wherein the trigger indicates a change in body position.

17. The trigger indicates a change in phasic and / or tonic activity of the genioglossus muscle during respiratory movements. The system of claim 1 .

18. The biomarkers are associated with stages of a sleep cycle, and the stages of the sleep cycle , Awake, Light NREM stage 1 sleep, Light NREM stage 2 sleep, Light NREM stage 2. The system of claim 1, wherein the sleep is in a deep sleep of level 3, a REM sleep, or a combination thereof. Hmm.

19. The initial rules of the algorithm used by the rule-based classification are based on historical values ​​for the patient, historical values ​​for the patient, and / or values ​​derived from the patient The system of claim 1 , wherein the first and second inputs are determined by the first and second inputs.

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