HK40063515A - Systems and methods for treating sleep disordered breathing - Google Patents

Description

System and method for treating sleep disordered breathing

Cross Reference to Related Applications

This application claims priority from U.S. provisional application No. 62/843,641 filed on 6.5.2019 and U.S. provisional application No. 62/815,393 filed on 8.3.2019, both of which are incorporated herein by reference.

Technical Field

The present disclosure relates to methods and systems for treating sleep disordered breathing by activating the sub-hyoid band muscles via neuromodulation.

Background

Sleep Disordered Breathing (SDB) occurs when partial or complete cessation of breathing occurs multiple times throughout the night. Obstructive Sleep Apnea (OSA) is an SDB that involves the cessation or significant reduction of airflow in the presence of respiratory effort. OSA is the most common type of SDB and is characterized by repeated episodes of upper airway collapse during sleep, which causes repeated pauses in breathing, followed by a decrease in blood oxygen saturation or neural arousal. The pathophysiology of OSA may involve factors such as craniofacial anatomy, airway collapse, and neuromuscular control of the upper airway dilating musculature. Electromyographic studies have shown that the tone and temporal activity of pharyngeal airway dilator muscles (such as the genioglossus muscle) diminishes from arousal to non-rapid movement of the eyes to rapid movement of the eyes.

Continuous Positive Airway Pressure (CPAP) therapy is the leading edge treatment of OSA. CPAP therapy utilizes a machine, typically comprising a flow generator, tubing and a mask designed to deliver a constant flow of air pressure to keep the airway of OSA patients continuously open. However, success of CPAP therapy is limited by compliance, with reported rates ranging from 50% to 70%. Hypoglossal Nerve Stimulation (HNS) has now been established as an effective form of therapy for patients with Obstructive Sleep Apnea (OSA) who cannot undergo positive airway pressure. This therapy works by making the tongue muscle prominent and stiff, thereby dilating the pharyngeal airway. However, only a small fraction of OSA patients have an anatomical structure suitable for sublingual nerve stimulation therapy, as many patients continue to suffer from airway collapse even under stimulation of the sublingual neuromuscular system.

Disclosure of Invention

The present disclosure relates to methods and systems for treating SDB in a patient suffering from SDB by activating a sub-hyoid band muscle via neuromodulation. In one aspect, a method for improving SDB in a patient having SDB comprises: delivering a neuromodulation signal to a target site proximate a cervical loop that innervates sternotomous muscle (sternothyroid muscle); and activating the sternal nail muscle to improve SDB in the patient. In another aspect, a method for improving SDB in a patient having SDB comprises: a neuromodulation signal is delivered to a target site proximate a collar that innervates the sternal nail muscle to activate the sternal nail muscle. The method further comprises the following steps: a neuromodulation signal is delivered to a target site proximate to a hypoglossal nerve (HGN) to activate the genioglossus muscle. Delivery of neuromodulation signals may improve SDB in a patient. Aspects of the present disclosure may further include: a neuromodulation signal is delivered to a target site proximate a collar that innervates sternohyoid muscles (sternohyoid muscles) to activate the sternohyoid muscles to improve SDB in a patient.

Drawings

Fig. 1 is a flow chart depicting illustrative steps of a method of improving SDB in a patient suffering from SDB.

Fig. 2 is a schematic diagram of an exemplary target site for neuromodulation according to one aspect of the present disclosure.

Fig. 3 is a schematic diagram of an exemplary target site for neuromodulation according to an aspect of the present disclosure.

Fig. 4 is a flow chart depicting illustrative steps of a method of improving SDB in a patient suffering from SDB, in accordance with an aspect of the present disclosure.

Fig. 5 is a block diagram depicting illustrative components of a neuromodulation system according to an aspect of the present disclosure.

Fig. 6 is a block diagram depicting illustrative components of a neuromodulator according to an aspect of the present disclosure.

Detailed Description

The present disclosure relates to systems and methods for improving SDB by activating one or more sub-hyoid ribbon muscles. Non-limiting examples of SDB are increased upper airway resistance, including snoring; upper Airway Resistance Syndrome (UARS); and sleep apnea. Sleep apnea may include OSA, Central Sleep Apnea (CSA), and mixed sleep apnea. As used herein with respect to the elements, the terms "a" and "an" and "the" include at least one or more of the elements unless otherwise indicated. Further, unless otherwise indicated, the terms "or" and "mean" and/or "and combinations thereof. Reference to "ameliorating" SDB in a patient includes treating SDB, reducing symptoms of SDB, alleviating SDB, or preventing SDB. In certain aspects, the method of improving SDB in a patient is prophylactic in nature rather than counter-acting. In other words, a method of improving SDB in a patient according to certain aspects comprises: SDB is prevented rather than, for example, detecting apnea or hypopnea events and responding to such detected events. By preventing SDB, treatment may reduce the likelihood of airway collapse, rather than reacting to documented events. As used herein, "neuromodulation", "neurostimulation", or "stimulation" refers to stimulating or inhibiting neural activity. Patients with SDB include mammals, such as humans.

The present disclosure provides methods and systems for treating SDB in a patient having SDB by activating one or more sub-hyoid ribbon muscles. Activation of one or more of the hyoid muscles may be accomplished by stimulating a collar, including one or both of the upper and lower roots of the collar, alone or in combination with stimulating the HGN. The stimulus may be an electrical stimulus. Further, stimulation includes unilateral stimulation as well as bilateral stimulation of these nerves. Without wishing to be bound by a particular mechanism of action, it is believed that activation of the infrahyoid muscles (e.g., tightening of these muscles) may reduce upper airway compliance (e.g., stiffening the upper airway). Upper airway compliance may indicate the likelihood of airway collapse and may be relevant to treating SDB. The infrahyoid muscles include sternohyoid, sternometacarpus, scapulohyoid, and thyrohyoid muscles, as described below. In one aspect, the present disclosure provides a method of activating one or more of these muscles, either alone or in combination with activating the genioglossus muscle. Activation of the genioglossus muscle may be achieved by neuromodulation of the hypoglossal nerve (HGN).

Referring to fig. 1, in one aspect, a method (100) of treating SDB in a patient having SDB comprises: a neuromodulation signal is delivered to a target site proximate to a collar that innervates at least sternal nail muscle (102). The target site may be proximal to the cervical tab such that delivery of the neuromodulation signal activates the motor fibers of the cervical tab. The method 100 further comprises: activating sternal nail muscles (104). The method (100) further comprises: improving SBD in a patient via delivery of neuromodulation signals (106).

Referring to fig. 2-3, the hyoid ribbon muscle may be variably innervated by nerve fiber contributions from both the upper and lower roots of the cervical loop. It should be noted that fig. 2 generally illustrates most, if not all, known branching patterns of the neck loop, but that there may not be actual anatomical variations with all of these branching patterns in a single patient. Normal anatomical variation may require the use of one or more different target sites in different patients to achieve the desired stimulation of sternal nail muscle 39. In certain aspects and referring to fig. 2, neuromodulation signals are delivered to target sites proximate to the collar 33, which also innervates the upper abdomen of sternohyoid muscle 37a and/or the lower abdomen of sternohyoid muscle 37b to activate some or all of sternohyoid muscle 37. For example, an exemplary target site includes target site a, which may be near or at branch point 43 of the upper root of neck loop 27 that innervates sternohyoid muscle 37, such that sternohyoid muscle 37 and sternohyoid muscle 39 are activated. In certain aspects, delivery of neuromodulation signals to target site a near the upper root of collar 27 may also activate some or all of scapulohyoid muscle 41(a and b). If the target site is distant from the superior root 27 of the cervical loop, but does not include a branch point 1000 (e.g., placed at site G), the neuromodulation signal may activate only the sternohyoid muscle 37 and/or the scapulolingual muscle 41, without necessarily activating the sternohyoid muscle 39 along with the sternohyoid muscle 37 and/or the scapulolingual muscle 41. Without wishing to be bound by a particular mechanism of action, it is believed that activation of at least sternum nail muscle 39 (including sternum nail muscle 39, sternohyoid muscle 37, and scapulolingual muscle 41) may stiffen the upper airway of the patient, thereby improving the patient's SDB.

In certain aspects, the neuromodulation signal is delivered to target site B proximate to a collar (e.g., proximate to the lower root 35 of the collar) that also innervates sternal nail muscle 39 and sternohyoid muscle 37 and scapulolingual muscle 41 to activate the innervated muscle or muscles. In certain aspects, neuromodulation signals may be delivered simultaneously to target sites a and B proximate to the collar 31 so as to stimulate nerve branches from the superior and inferior roots 27, 35 of the collar, which innervate sternal thyroid muscle 39 as well as sternohyoid muscle 37 and scapulolingual muscle 41. In certain aspects, delivery of neuromodulation signals to target site E (e.g., proximate to or at a branch point of one or more common trunk nerves 1000 created by a loop of cervical loop 33 that combines nerve fibers from upper and lower roots 27, 35 and supplies at least sternohyoid muscle 39 and variably supplies sternohyoid muscle 37 and scaphyoid muscle 41) may activate at least sternohyoid muscle 39, and in certain aspects, sternohyoid muscle 37, and in certain aspects, scaphyoid muscle 41. In certain aspects, delivery of a neuromodulation signal to target site F (e.g., near or at a branch point of one or more sternal thyroid nerves from copral 1001) may activate sternal thyroid 39. The branch leading to the sternal nail muscle may be a single nerve fiber or several closely positioned nerve fibers that travel together. It should be noted that the above target sites are merely exemplary and that the therapeutic device (such as one or more electrodes) may be placed at other portions of the neck tab, including its branches. In certain aspects, neuromodulation signals are not delivered to the HGN proximate the branch point 43, as it is believed that a separate therapeutic device (such as an electrode) may be required to potentially provide different stimulation intensities or timings to the neck loop and the HGN. In other aspects, the HGN may be stimulated proximate to or distal from the branch point where the posterior moving muscle branches to the styloglossus and/or hyoglossus muscles. Further, the stimulus may be applied to any combination of the sites and branches described above. For example, for target site E, a therapeutic device (such as one or more electrodes) may be placed proximal or distal to the branch to the scapulohyoid muscle such that the stimulation captures only the sternum thyroid/sternohyoid muscle fibers. As another example, for target site F, one or more skin-clamp (cuff) electrodes may surround a single or multiple fibers innervating the sternal nail muscle.

Referring to fig. 4, in another aspect, a method (200) for improving SDB in a patient having SDB comprises: a neuromodulation signal is delivered to a target site proximate a collar that innervates at least sternal nail muscle (202). The method 200 further comprises: activating sternal nail muscles (204). In certain aspects, neuromodulation signals are also delivered to target sites proximate to the collar that also innervates the sternohyoid muscles, so as to also activate the sternohyoid muscles. The method (200) further comprises: a neuromodulation signal is delivered to a target site proximate to an HGN innervating at least the genioglossus muscle (206). The target site may be proximal to the HGN such that delivery of the neuromodulation signal activates a motor fiber of the HGN. The method 200 further comprises: the genioglossus muscle is activated (208). The method (200) further comprises: sleep disordered breathing in a patient is improved via delivery of neuromodulation signals (210). Without wishing to be bound by a particular mechanism of action, it is believed that at least activation of the sternal nail muscle may stiffen the patient's upper airway, and at least activation of the genioglossus muscle may move the tongue forward and expand/strengthen the patient's upper airway, thereby improving the patient's SDB.

Delivery of neuromodulation signals, such as electrical neuromodulation signals, may be achieved by placing one or more therapeutic devices (such as electrodes/electrical contacts/neurostimulation devices) proximate to a target site that innervates one or more sub-hyoid ribbon muscles. The treatment devices, such as electrodes, may be placed in various different ways proximate to the target site, such as, for example, percutaneously, subcutaneously, intramuscularly, intraluminally, transvascularly, intravascularly, or via direct open surgical implantation. The electrodes may also have different form factors, such as injectable microstimulators, nerve cuff electrodes, or transdermal patches.

The electrodes or neurostimulators may be placed at the same or different target sites. For example, if the target site includes the upper root of the neckloop and the lower root of the neckloop, separate nerve cuff electrodes may be placed on each root, where each nerve cuff electrode has its own cathode and anode, but is connected to the same pulse generator, or separate nerve cuff electrodes are connected to the same pulse generator, but one nerve cuff electrode serves as the cathode and the other as the anode, where the generated electric field captures both roots. In certain embodiments, a therapeutic device configured to stimulate the cervical loop (such as one or more electrodes) may be combined with a therapeutic device configured to stimulate the hypoglossal nerve (such as an electrode). Still alternatively, the therapeutic device configured to stimulate the cervical loop (such as one or more electrodes) may be part of a device separate from the device configured to stimulate the hypoglossal nerve. The electrodes may be operably coupled to the same single pulse generator or separate pulse generators (within the same physical housing or separate housings).

The electrodes may be controllable to provide output signals that may vary in voltage, frequency, pulse width, current, and intensity, for example. The electrodes may also provide positive and negative currents from the electrodes and/or may be capable of blocking current from the electrodes and/or changing the direction of current from the electrodes. The electrodes may be in electrical communication with an electrical energy generator, such as a battery or pulse generator. For example, the electrical energy generator may comprise a battery that is rechargeable by inductive coupling. The electrical energy generator may be positioned at any suitable location, such as adjacent to the electrode (e.g., implanted adjacent to the electrode), or at a remote site in or on the body of the mammal or remote from the body of the mammal at the remote location. The electrodes may be connected wirelessly or via wires to a remotely located electrical energy generator.

The electrical energy generator may control, for example, a pulse shape of the electrical neuromodulation signal, a signal pulse width, a signal pulse frequency, a signal pulse phase, a signal pulse polarity, a signal pulse amplitude, a signal pulse intensity, a signal pulse duration, and combinations thereof. The electrical energy generator may be programmed to deliver various currents and voltages to one or more electrodes and thereby modulate the activity of a nerve, neuron, or neural structure. The electrical energy generator can be programmed to control the plurality of electrodes independently or in various combinations as needed to provide neuromodulation. In some cases, the electrodes may be powered by contacting a power source external to the patient's body with the patient's skin, or the electrodes may include an integrated power source.

The electrical neuromodulation signals may be constant, intermittent, varying, and/or modulated with respect to current, voltage, pulse width, waveform, period, frequency, amplitude, and/or the like. The waveform may be a sine wave, a square wave, etc. The type of stimulation may vary and involve different waveforms. An optimal activation pattern may require a delay in one electrode before the other is activated, or optimally opening the airway in another coordinated manner, whether this involves simultaneous activation or staggered activation in a coordinated, adjustable manner.

A controller or programmer may also be associated with the nerve stimulation device. For example, the programmer may comprise one or more microprocessors under control of a suitable software program. The programmer may include other components, such as an analog-to-digital converter, and the like.

The neurostimulation device may be preprogrammed with desired stimulation parameters. The stimulation parameters may be controllable such that the neuromodulation signals may be remotely adjusted to a desired setting without removing the electrode from its target location. For example, remote control may be performed using conventional telemetry techniques with an electrical signal generator and battery, a radio frequency receiver coupled to an external transmitter, and the like.

The methods disclosed herein may be used as part of a closed loop system (as described in more detail below). Such a method may include: sensing a physiological parameter associated with the SDB; generating a sensor signal based on the physiological parameter; and activating a therapy delivery device, such as an electrode, in response to the sensor signal to modulate application of the neuromodulation signal to the target site, thereby improving the SDB of the patient.

Aspects of the disclosure also provide a system for improving SDB in a patient suffering from SDB. Referring to fig. 5 and 6, in one embodiment, the neurostimulation system 10 includes a neurostimulator 12, an external device 14 that transmits signals to the neurostimulator 12, a patient programming device 16 in bi-directional communication with the neurostimulator 12 and/or the external device 14, and a physician programming device 18. As described below, the various components of the system may be in communication (e.g., electrical communication) with each other. In some cases, two or more components of a system may communicate wirelessly with each other. In other cases, two or more components of the system may be in wired communication with each other. In this manner, some components of the system may communicate wirelessly with each other while other components communicate wiredly with each other. Further, in the illustrative embodiments disclosed herein, communication between components included in the neurostimulation system 10 is configured to be bi-directional in nature. However, communication between two or more system components may be unidirectional. Further, the functionality of different components of the system may be combined into a single device. For example, the functionality of the external device and the components of the patient programming device may be combined into a single device.

In one embodiment, the neurostimulator 12 includes electronic circuitry for delivering neurostimulation pulses, such as one or more electronic circuits, enclosed in a sealed housing and coupled to the electrodes. In certain embodiments, the neurostimulator 12 may include a primary battery, a rechargeable battery, or an inductively coupled power source for providing power for generating and delivering stimulation pulses and for powering other device functions, such as communication functions. The neurostimulator 12 or the system 10 may include fixation members to secure the neurostimulator to tissue adjacent the target site.

The external device 14 may be a wearable device that includes a strap, patch, or another attachment member or members for operatively securing the external device 14 to the patient in proximity to the neurostimulator 12. In some cases, the external device 14 may be programmed to provide user feedback to help the patient optimize placement of the external device 14 around the subject's body. When the neurostimulator 12 is provided with a rechargeable battery, the external device 14 may comprise a recharging unit for transferring power, e.g. inductive power transfer, from the external device 14 to the neurostimulator 12. In this embodiment, the programming device 16 may be a patient-held device for initiating and terminating therapy delivered by the neurostimulator 12 via the bi-directional wireless telemetry link 20. Alternatively, programming device 16 may be operated by the patient to communicate with wearable external device 14 to control the on and off times of the therapy and other therapy control parameters, which are transmitted to neurostimulator 12 via communication link 24. Programming device 16 may communicate with wearable external device 14 via a two-way wireless telemetry link 22, which may establish communication over distances up to several feet, enabling far telemetry such that the patient does not need to position programming device 16 directly on neurostimulator 12 to control the on and off times of the treatment or perform other interrogation or programming operations (e.g., programming of other treatment control parameters).

When the neurostimulator 12 includes one or more primary batteries, the external device 14 may be optional. Programming of neurostimulator 12 may be performed by programming device 16 using near or far telemetry to establish a bi-directional communication link 20 for transmitting data between programming device 16 and neurostimulator 12. The programming device 16 may be used by the patient or clinician to set the treatment protocol that is automatically performed by the neurostimulator 12. Programming device 16 may be used to manually start and stop therapy, adjust therapy delivery parameters, and collect data from neurostimulator 12, such as data related to total accumulated therapy delivery time or other data related to device operations or measurements performed by neurostimulator 12. For example, the programming device 16 may include software programmed to control one or more stimulation and/or control parameters associated with the neurostimulator 12. Additionally, or alternatively, the programming device 16, including software, may be programmed to store patient treatment data, such as log questions or physiological measurements. The programming device 16 may also include software programmed to access a remote data source, query certain data, and then provide stimulation instructions to the system 10 based on the queried data. For example, programming device 16 may include software programmed to provide neurostimulator 12 with customizable or patient-triggered alerts, e.g., indicating stimulation periods and durations of the respective periods, after a desired period of time (e.g., 30 minutes) following sleep onset. The programming device 16 may be embodied as a smart phone or tablet, but may also include a Personal Computer (PC).

When the neurostimulator 12 is configured as an externally powered device, the external device 14 may be a power transmission device worn by the patient during sleep to provide the power required to generate the stimulation pulses. For example, the external device 14 may be a battery-powered device that includes a primary coil for inductively transmitting power to a secondary coil included in the neurostimulator 12. The external device 14 may include one or more primary and/or rechargeable batteries and thus may include, for example, a power adapter and plug for recharging in a standard 110V or 220V wall outlet.

In some embodiments, the functions required to transmit power to the neurostimulator 12 and to program the neurostimulator 12 to control therapy delivery when the neurostimulator 12 is embodied as a rechargeable or externally powered device may be implemented in a single external device. For example, the power transmission capabilities of the external device 14 and the programming capabilities of the patient programmer 16 may be combined in a single external device, which may be a wearable or handheld device (e.g., a smartphone or tablet).

The physician programming device 18 may include added programming and diagnostic functionality as compared to the patient programming device 16. For example, the physician programming device 18 may be configured to program all neurostimulation therapy control parameters, such as, but not limited to, pulse amplitude, pulse width, pulse shape, pulse frequency, duty cycle, therapy on and off times, electrode selection, and electrode polarity assignment. The patient programming device 16 may be limited to turning therapy on and/or off, adjusting the start time of the therapy and/or adjusting the pulse amplitude without the patient having full access to all programming functions, such that the patient does not have access to or change some programming functions and programmable therapy control parameters.

The physician programming device 18 may be configured to communicate directly with the neurostimulator 12 via the wireless two-way telemetry link 28, for example, during a clinic visit. Additionally or alternatively, the physician programming device 18 may operate as a remote programming instrument for transmitting programming commands to the patient programming device 16 via a wired or wireless communication network link 30, after which the patient programming device 16 automatically transmits programming data to the neurostimulator 12 via the bi-directional telemetry link 20 (or via the wearable external device 14 and link 24). For example, the physician-programming device may be embodied as a smartphone, tablet, or PC.

In some embodiments, the patient may be provided with a magnet for modulating the operation of the neurostimulator 12. For example, application of the magnet may turn therapy on or off or cause other binary or step-wise adjustments to the operation of the neurostimulator 12.

Fig. 6 is a functional block diagram of the neurostimulator 12 of fig. 5 according to an embodiment of the neurostimulation system. Neurostimulator 12 may include a housing 34 enclosing a controller 36 and associated memory 38, a telemetry module 40, and a pulse generator 42 coupled to one or more electrodes 44. The neurostimulator 12 includes a power source 46, which, as noted above, may include any of a primary battery, a rechargeable battery, and/or a secondary coil of an external power supply system.

The controller 36 may comprise any one or more of a microprocessor, Digital Signal Processor (DSP), Application Specific Integrated Circuit (ASIC), Field Programmable Gate Array (FPGA), or equivalent discrete or integrated logic circuitry. In some examples, controller 36 may include multiple components, such as any combination of one or more microprocessors, one or more controllers, one or more DSPs, one or more ASICs, or one or more FPGAs, as well as other discrete or integrated logic circuitry. The functionality attributed to controller 36 herein may be embodied as software, firmware, hardware, or any combination thereof. In one example, a neural stimulation therapy regime for improving patient SDB may be stored or encoded as instructions in memory 38 that are executed by controller 36 to cause pulse generator 42 to deliver therapy via electrodes 44 according to a programmed regime.

Memory 38 may include computer readable instructions that, when executed by controller 36, cause neurostimulator 12 to perform various functions attributed throughout this disclosure to the neurostimulator. The computer readable instructions may be encoded within the memory 38. Memory 38 may include non-transitory computer-readable storage media including any volatile, non-volatile, magnetic, optical, or electrical media, such as Random Access Memory (RAM), Read Only Memory (ROM), non-volatile RAM (nvram), electrically erasable programmable ROM (eeprom), flash memory, or any other digital media, with the sole exception of transitory propagating signals.

Telemetry module 40 and associated antenna 48 may be provided for establishing two-way communication with external device 14, patient programmer 16, and/or physician programmer 18. Examples of communication techniques used by neurostimulator 12 and programming devices 16 or 18 include low frequency or Radio Frequency (RF) telemetry, which may be an RF link established via bluetooth, WiFi, or MICS, for example. The antenna 48 may be located within, along, or extend outwardly from the housing 34.

The electrodes 44 may be positioned along an outer surface of the housing 44 and may be coupled to the pulse generator 42 via an insulated feedthrough or other connection, as will be described further below. In other embodiments, the electrodes 44 may be carried by leads or insulating tethers that are electrically coupled to the pulse generator 42 via suitable insulating feedthroughs or other electrical connections across the sealed housing 34. In other embodiments, electrode 44 may be incorporated in housing 34 having an externally exposed surface adapted to be operably positioned near a target site proximate a nerve and electrically coupled to pulse generator 42.

In another aspect, the system 10 may include one or more sensors (not shown) to allow open or closed loop control. For example, in an open loop system, the system 10 may include one or more sensors such that the patient may manage (e.g., prophylactically) improvement in SDB based on feedback (e.g., detected signals) from the one or more sensors. Such detected signals may indicate the onset of SDB, such as changes in muscle or neuroelectrical activity, tongue position, oropharyngeal airflow, and the like. Upon noticing the one or more signals, the patient may then trigger or activate the neurostimulator 12 to prevent or alleviate SDB.

In another aspect, the system 10 may include one or more sensors to allow closed loop control, for example, by responding automatically (e.g., by activation of the neurostimulator 12) in response to sensed physiological parameters or related symptoms or signs that indicate the degree and/or presence of SDB, including respiratory state (e.g., inspiration/expiration) or changes in sleep/wake state and/or sleep stages (e.g., REM or non-REM) and/or the onset/termination of sleep of the patient. Physiological parameters include changes in muscle or neuroelectrical activity, tongue position, changes in heart rate or blood pressure, changes in pressure in response to respiratory effort, oropharyngeal airflow, accelerometer data, position data, electroencephalographic data, and the like. The sensors used as part of a closed or open loop system may be placed at any suitable anatomical location on the patient, including skin surfaces, oral, nasal, mucosal surfaces, or subcutaneous locations. The sensor may also be placed in proximity to the patient but not in contact with the patient, such as a sensor placed in proximity to the patient that detects respiratory effort and then communicates with the neurostimulator by wired or wireless means. In certain aspects, the system may include sensors to detect SDB events and activate or pace breathing or adjust the duty cycle after automatically detecting the sleep state of the patient.

The various disclosed aspects and embodiments of the disclosure may be considered alone or in combination with other aspects, embodiments, and variations of the disclosure. Unless otherwise specified, the steps of the methods of the present disclosure are not limited to any particular order of execution. Further, although described above with respect to electrical stimulation, other forms of electromagnetic energy may be used, such as ultrasound, magnetic, radio frequency, thermal or optical energy.

Claims (12)

1. A method of treating Sleep Disordered Breathing (SDB) in a patient suffering therefrom, comprising:

delivering a neuromodulation signal to a target site proximate a collar that innervates sternal nail muscle;

activating the sternal nail muscle; and

improving sleep disordered breathing in the patient via delivery of the neuromodulation signal.

2. The method of claim 1, further comprising:

delivering a neuromodulation signal to a target site proximate a collar that innervates sternohyoid muscles; and

activating the sternal-hyoid muscles.

3. The method of claim 1, wherein the target site is proximal to or at a branch point of the upper root of the neck tab.

4. The method of claim 1, wherein the target site is proximal to the lower root of the cervical tab.

5. The method of claim 1, further comprising:

delivering a neuromodulation signal to a target site proximate a collar of a neck that innervates the scapulohyoid muscle; and

activating the scapulolingual muscle.

6. The method of claim 1, further comprising:

delivering a neuromodulation signal to a target site proximate a hypoglossal nerve (HGN) that innervates the genioglossus muscle; and

activating the genioglossus muscle.

7. The method of claim 2, further comprising:

delivering a neuromodulation signal to a target site proximate to an HGN that innervates the genioglossus muscle; and

activating the genioglossus muscle.

8. The method of claim 6, wherein the target site proximal to the HGN is distal to or at a branch point of the upper root of the HGN and the neck tab.

9. The method of claim 6, wherein the target site proximal to the HGN is distal to a branch point of the HGN that innervates tongue-contracting muscle.

10. The method of claim 1, wherein improving SBD of the patient comprises preventing collapse of the airway of the patient.

11. The method of claim 1, wherein the SDB is snoring, obstructive sleep apnea, or a combination thereof.

12. The method of claim 1, wherein the neuromodulation signal is an electrical neuromodulation signal.