Methods and systems for treating sleep disordered breathing

Abstract

This disclosure provides a delivery system for a method of maintaining upper airway patency. The method includes placing at least one electrode in electrical communication with a target site of a patient's palatine muscles, pharyngeal muscles, and / or nerves innervating said palatine muscles and / or said pharyngeal muscles. The method further includes activating said at least one electrode to deliver an electrical signal to said target site. The target site may be selected to target a specific muscle or nerve involved in upper airway function. The electrical signal stimulates motor neurons or muscle fibers to induce contraction of the target muscle, thereby maintaining upper airway patency. The delivery system includes at least one electrode, a power source, and a controller that communicates with said at least one electrode and is programmed to direct the delivery of an electrical signal via said electrode to the target site.

Description

[0001] Cross-reference to related applications

[0002] This application is a PCT international application claiming priority to U.S. Provisional Application No. 63 / 515,165, filed July 24, 2023, entitled “Methods and Systems for Treating Sleep-Disordered Breathing.”

[0003] The content of each of the applications cited above is incorporated herein by reference in its entirety. Technical Field

[0004] This disclosure relates to methods and systems for treating sleep-disordered breathing by activating palatal and pharyngeal muscle tissue through neural modulation. Background Technology

[0005] Sleep-disordered breathing (SDB) is a condition characterized by pauses or disturbances in breathing during sleep. Obstructive sleep apnea (OSA) is a highly prevalent form of sleep-disordered breathing, characterized by recurrent airway obstruction during sleep leading to airflow limitation or cessation. Recurrent airflow limitation or cessation results in hypoxemia and hypercapnia, or increased blood carbon dioxide levels, due to reduced lung ventilation. Hypercapnia leads to recurrent arousal and increased airway muscle activity to open the airway and restore airflow. Hypoxemia causes recurrent arousal during sleep, limiting the patient's ability to achieve peaceful sleep, and increased sympathetic activity leads to elevated heart rate and blood pressure. Chronic, untreated hypoxemia due to airway obstruction increases the risk of hypertension, cerebrovascular events, cardiovascular events, and metabolic diseases such as diabetes. After arousal and airflow restoration, the patient returns to sleep and further airway collapse occurs, leading to further airflow limitation, arousal, and the aforementioned physiological effects. Recurrent arousal results in poor sleep quality, leading to daytime sleepiness and poor cognitive function. Snoring is a pathological sign of upper airway obstruction in sleep-disordered breathing. Simple snoring represents a syndrome in which airflow cessation (apnea) and airflow limitation (hypospiracle) occur less frequently and pose a minor risk to the brain and cardiovascular system; however, it can be disruptive to the sleep environment and bed partner. Simple snoring or snoring without OSA is typically defined as an apnea-hypospiracle index (AHI) of less than 5 per hour. Mild OSA is typically defined as an AHI < 15, moderate as an AHI 15-30, and severe as an AHI > 30.

[0006] Multiple mechanisms contribute to obstruction and airflow limitation, including anatomical and physiological factors. Anatomical factors include soft tissue and craniofacial anatomy, airway volume, and tissue collapse. Physiological factors include neuromuscular control, circuit gain, and arousal threshold. A key mechanism for airflow limitation is weakened neuromuscular control in the upper airway muscles, leading to intermittent and recurrent airway collapse and obstruction. Without treatment, OSA can affect daytime sleepiness and function, and raise cardiovascular, metabolic, and stroke risks.

[0007] Continuous positive airway pressure (CPAP) is the gold standard first-line treatment for all phenotypes of OSA. It is highly effective for patients who adhere to CPAP therapy, but up to 50% of patients do not adhere to it. Surgical options are available for patients who are intolerant to CPAP therapy seeking disease remission; however, not all phenotypes of OSA are well treated surgically. A specific phenotype is complete concentric palatine collapse (CCCp), characterized by frequent complete collapse of the posterior palatine and lateral palatopharyngeal walls. It affects up to 30% of OSA patients and is associated with greater disease severity (more frequent and severe airway collapses) and a higher propensity for CPAP failure. Modern upper airway surgery and neurostimulation techniques are only partially effective in treating CCCp. Contemporary neurostimulation methods have focused on the hypoglossal nerve (which is contraindicated in CCCp patients) and more recently on the cervical loop nerve.

[0008] Modern neurostimulation methods for sleep-disordered breathing target the genioglossus muscle, the largest airway dilator, which causes tongue protrusion, increased airway volume, and improved airflow. Neck loop stimulation has been proposed to address lateral tracheal collapse by activating the infrahyoid band muscle, causing caudal tracheal traction and reinforcement of the pharyngeal lateral wall. However, concentric palatal collapse (a combination of oropharyngeal / palatopharyngeal lateral wall collapse and anterior / posterior oropharyngeal / palatopharyngeal airway collapse) occurs independently of these mechanisms, and no neurostimulation methods have been proposed or explored in this field that directly target this neglected mechanism.

[0009] This disclosure aims to overcome one or more of the aforementioned challenges. Summary of the Invention

[0010] According to certain aspects of this disclosure, systems, methods, and computer-readable storage devices for treating sleep-disordered breathing are disclosed.

[0011] In some cases, a method for maintaining upper airway patency may include: placing at least one electrode in the patient to electrically communicate with a target site of the palatine muscles, pharyngeal muscles and / or nerves innervating the palatine muscles and / or pharyngeal muscles; and activating at least one electrode to deliver an electrical signal to the target site.

[0012] In some cases, a delivery system placed inside the oral cavity, nasal cavity, oropharynx, and / or nasopharynx may include: at least one electrode configured to deliver electrical signals to a target site that is a nerve or muscle; a power source that communicates with the at least one electrode via wired or wireless communication; and a controller that communicates with the at least one electrode and is programmed to direct the delivery of electrical signals to the target site via the at least one electrode.

[0013] Additional objectives and advantages of the disclosed technology will be set forth in part in the following description, and will be apparent in part from that description, or may be learned by practice of the disclosed technology.

[0014] It should be understood that both the foregoing general description and the following detailed description are exemplary and interpretive only, and do not limit the disclosed technology claimed. Attached Figure Description

[0015] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate various exemplary aspects and, together with the description, serve to explain the principles of the disclosed technology.

[0016] Figure 1 A flowchart is depicted for a method of treating sleep-disordered breathing by neuromodulating the nerves of the palate and pharyngeal muscle tissue.

[0017] Figure 2 A flowchart is depicted for a method of treating sleep-disordered breathing by neuromodulating the muscles of the palate and pharynx.

[0018] Figure 3 A flowchart is depicted for a method of treating sleep-disordered breathing by neuromodulating and activating the muscles of the palate and pharynx.

[0019] Figure 4 The diagram depicts the nerves of the palate and pharyngeal muscles, as well as schematic diagrams of the palate and pharyngeal muscles.

[0020] Figure 5 A schematic diagram depicting an intraoral view of the palate and pharyngeal muscle tissue.

[0021] Figure 6 A flowchart depicting the neural regulation of the tongue's internal and external muscular tissues is provided.

[0022] Figure 7 A schematic diagram depicting the muscular tissues inside and outside the tongue.

[0023] Figure 8 A flowchart depicts the neural modulation of the palatal and pharyngeal muscle tissues, as well as the neural modulation of the hypoglossal and cervical loop nerves.

[0024] Figure 9 A flowchart depicts the neural modulation of the palatal and pharyngeal muscle tissues, as well as the neural modulation of the hypoglossal nerve and the cervical loop nerve.

[0025] Figure 10 The flowcharts depict the neural modulation of the palatal and pharyngeal muscle tissues, the neural modulation of the palatal and pharyngeal muscle tissues, and the neural modulation of the intralingual and extralingual muscle tissues.

[0026] Figure 11 The flowcharts depict the neural modulation of the palatal and pharyngeal muscle tissues, the neural modulation of the palatal and pharyngeal muscle tissues, and the neural modulation of the hypoglossal and cervical loop nerves.

[0027] Figure 12 The flowcharts depict the neural modulation of the palatal and pharyngeal muscle tissues, the neural modulation of the intralingual and extralingual muscle tissues, and the neural modulation of the hypoglossal and cervical loop nerves.

[0028] Figure 13 A schematic diagram of a non-implantable neuromodulation system is depicted.

[0029] Figure 14 A schematic diagram of an implantable neuromodulation system is depicted.

[0030] Figure 15 A schematic diagram depicts an embodiment of a neuromodulation therapy delivery system.

[0031] Figure 16A A schematic diagram depicts an embodiment of a neuromodulation therapy delivery system.

[0032] Figure 16B A schematic diagram (side view) depicting an embodiment of a neuromodulation therapy delivery system.

[0033] Figure 17 A diagram depicts the charging box and remote subsystem of the neuromodulation therapy delivery system.

[0034] Figure 18 Schematic diagrams depicting embodiments of a neuromodulation therapy delivery system. Left: Showing an embodiment of the electrode layout at the insertion point on the upper medial side of the palatoglossus muscle and an embodiment of the electrode placed on the posterior trigone of the molar. Right: Showing an embodiment of the electrode layout at the insertion point on the upper medial side of the palatoglossus muscle and an embodiment of the electrode placed on the third mandibular molar. Far right: Showing an embodiment of the non-conductive coating and receiving electrode on the third mandibular molar.

[0035] Figure 19A schematic diagram depicting an embodiment of a neuromodulation therapy delivery system shows the layout of multiple electrodes positioned close to various muscle targets in the palate and pharynx.

[0036] Figure 20 A schematic diagram depicts an embodiment of a neuromodulation therapy delivery system, showing the layout of multiple electrode arrays positioned close to various muscle targets in the palate and pharynx.

[0037] Figure 21 A schematic diagram depicting an embodiment of a neuromodulation therapy delivery system shows a layout (sagittal view) of multiple electrodes positioned close to the upper and lower ends of the palatopharyngeal and palatoglossal muscles.

[0038] Figure 22 A schematic diagram depicts an embodiment of a neuromodulation therapy delivery system, showing a customized, patient-specific electrode layout and system components.

[0039] Figure 23 A schematic diagram depicts an embodiment of a neuromodulation therapy delivery system, showing an electrode array and a battery designed to provide stimulation to tongue muscles in contact with the underside of the device.

[0040] Figure 24 Example systems that can perform the techniques presented in this paper are described. Detailed Implementation

[0041] This disclosure relates to methods and systems for treating patients with sleep-disordered breathing by activating palatal and pharyngeal muscle tissue through neural modulation.

[0042] 1. Introduction

[0043] In one aspect, a method for improving sleep-disordered breathing in a patient includes: delivering a neurally modulated signal (such as an electrical or magnetic or ultrasonic or piezoelectric or radiation signal or an electromagnetic or radiofrequency or mechanical or chemical or optical or acoustic signal or any other signal, and / or any combination thereof) to a nerve innervating the palatal and / or pharyngeal muscles; and activating one or more electrodes to deliver the neurally modulated signal (such as an electrical or magnetic or ultrasonic or radiofrequency or mechanical or chemical or optical or acoustic signal, and / or any combination thereof) to a target site on the nerve or muscle to improve the patient's sleep-disordered breathing.

[0044] In another aspect, a method for improving sleep-disordered breathing in a patient includes delivering a neurally modulated signal (such as an electrical or magnetic or ultrasonic or piezoelectric or radiation signal or an electromagnetic signal or radio frequency or mechanical or chemical or optical or acoustic signal or any other signal, and / or any combination thereof) to a target site, wherein the target site is a palatine and / or pharyngeal muscle, or a nerve innervating the palatine and / or pharyngeal muscle, the palatine and / or pharyngeal muscle including: tensor veli palatini, levator veli palatini, palatopharyngeal muscle, palatoglossus muscle, uvula muscle, superior retractor muscle, middle retractor muscle, and / or any combination thereof, in order to improve the patient's sleep-disordered breathing.

[0045] On the other hand, a method for improving sleep-disordered breathing in patients consists of delivering a neuromodulatory signal (such as an electrical or magnetic or ultrasonic or piezoelectric or radiation signal or an electromagnetic signal or radio frequency or mechanical or chemical or optical or acoustic signal or any other signal, and / or any combination thereof) to a target site, wherein the target site is an intralingual muscle (such as an upper longitudinal muscle or a lower longitudinal muscle or a transverse muscle or a vertical muscle) or an extralingual muscle (such as a genioglossus or a hyoidoglossus or a styloglossus), and / or any combination thereof, in order to improve the patient's sleep-disordered breathing.

[0046] On the other hand, a method for improving sleep-disordered breathing in patients consists of delivering neuromodulatory signals (such as electrical or magnetic or ultrasonic or piezoelectric or radiation signals or electromagnetic signals or radio frequency or mechanical or chemical or optical or acoustic signals or any other signals, and / or any combination thereof) to target sites of the hypoglossal nerve, cervical loop nerve, branches of the pharyngeal plexus to the palatopharyngeal muscle, branches of the pharyngeal plexus to the middle constrictor muscle, sternothyroid muscle, thyrohyoidohyoid muscle, omohyoidohyoid muscle, sternohyoidohyoid muscle, and / or any combination thereof, in order to improve the patient's sleep-disordered breathing.

[0047] On the other hand, a method for improving sleep-disordered breathing in patients consists of delivering neuromodulatory signals (such as electrical or magnetic or ultrasonic or piezoelectric or radiation signals or electromagnetic signals or radio frequency or mechanical or chemical or optical or acoustic signals or any other signals, and / or any combination thereof) to target sites of the hypoglossal nerve, cervical loop nerve, branches of the pharyngeal plexus to the palatopharyngeal muscle, branches of the pharyngeal plexus to the middle constrictor muscle, branches of the pharyngeal plexus to the pharyngeal muscle, branches of the pharyngeal plexus to the airway muscle, cranial nerves, vagus nerve, glossopharyngeal nerve, trigeminal nerve, branches of the trigeminal nerve, maxillary nerve, branches of the maxillary nerve, mandibular nerve, branches of the mandibular nerve, spinal nerve roots innervating the pharyngeal muscles, spinal nerve roots innervating the airway muscle, spinal nerve roots innervating the diaphragm, brainstem locations innervating the pharyngeal muscles, brainstem locations innervating the airway muscle, brainstem locations innervating the diaphragm, sternothyroid muscle, thyrohyoidohyoid muscle, omohyoidohyoid muscle, sternohyoidohyoid muscle, and / or any combination thereof, in order to improve the patient's sleep-disordered breathing.

[0048] In another aspect, a method for improving sleep-disordered breathing in patients includes: delivering a neurally modulated signal (such as an electrical or magnetic or ultrasonic or piezoelectric or radiation signal or electromagnetic signal or radio frequency or mechanical or chemical or optical or acoustic signal or any other signal, and / or any combination thereof) to a target site, wherein the target site is a nerve innervating the palatine and / or pharyngeal muscles; and activating one or more electrodes to deliver the neurally modulated signal (such as an electrical or magnetic or ultrasonic or piezoelectric or radiation signal or electromagnetic signal or radio frequency or mechanical or chemical or optical or acoustic signal or any other signal, and / or any combination thereof) to the target site of the nerve or muscle; and / or the target location. The target site is a palatine and / or pharyngeal muscle, or a nerve innervating the palatine and / or pharyngeal muscle, including: tensor veli palatini, levator veli palatini, palatopharynx, palatoglossus, uvula, superior retractor, and middle retractor; and / or a target site is an intralingual muscle (such as an upper longitudinal or lower longitudinal or transverse or vertical muscle) or an extrinsic muscle (such as a genioglossus, hyoidoglossus, or styloglossus); and / or a target site of the hypoglossal nerve, the cervical loop nerve, branches of the pharyngeal plexus to the palatopharynx, branches of the pharyngeal plexus to the middle retractor, the sternothyroid, thyrohyoidoglossus, omohyoidoglossus, sternohyoidoglossus, and / or any combination thereof, to improve sleep-disordered breathing in patients.

[0049] In another aspect, a method for improving sleep-disordered breathing in patients includes: delivering a neurally modulated signal (such as an electrical or magnetic or ultrasonic or piezoelectric or radiation signal or an electromagnetic signal or radiofrequency or mechanical or chemical or optical or acoustic signal or any other signal, and / or any combination thereof) to a target site, wherein the target site is a nerve innervating the palatine and / or pharyngeal muscles; and activating one or more electrodes to deliver the neurally modulated signal (such as an electrical or magnetic or ultrasonic or piezoelectric or radiation signal or an electromagnetic signal or radiofrequency or mechanical or chemical or optical or acoustic signal or any other signal, and / or any combination thereof) to: a nerve or muscle target site; and / or a target site, wherein the target site is a palatine and / or pharyngeal muscle, or a nerve innervating the palatine and / or pharyngeal muscle, the palatine and / or pharyngeal muscles including: tensor veli palatini, levator veli palatini, palatopharynx, palatoglossus, uvula, superior retractor, and middle retractor; and / or the target site. The target site is an intralingual muscle (such as an upper longitudinal muscle, lower longitudinal muscle, transverse muscle, or vertical muscle) or an lateral tongue muscle (such as a genioglossus, hyoidoglossus, or stylohyoidus); and / or the hypoglossal nerve, cervical loop nerve, branches of the pharyngeal plexus to the palatopharyngeal muscle, branches of the pharyngeal plexus to the middle constrictor muscle, branches of the pharyngeal plexus to the pharyngeal muscle, branches of the pharyngeal plexus to the airway muscle, cranial nerves, vagus nerve, glossopharyngeal nerve, trigeminal nerve, branches of the trigeminal nerve, maxillary nerve, branches of the maxillary nerve, mandibular nerve, and inferior lateral nerve. Target sites of branches of the jaw nerve, cranial roots of the accessory nerve, spinal nerve roots innervating the pharyngeal muscles, spinal nerve roots innervating the airway muscles, spinal nerve roots innervating the diaphragm, brainstem locations innervating the pharyngeal muscles, brainstem locations innervating the airway muscles, brainstem locations innervating the diaphragm, sternothyroid, thyrohyoid, omohyoid, sternothyroid, thyrohyoid, omohyoid, sternohyoid, and / or any combination thereof, in order to improve sleep-disordered breathing in patients.

[0050] On the other hand, a therapeutic delivery system placed inside the oral cavity and / or nasal cavity and / or oropharynx and / or nasopharynx comprises: at least one electrode configured to deliver neuromodulatory signals (such as electrical or magnetic or ultrasonic or piezoelectric or radiation signals or electromagnetic signals or radio frequency or mechanical or chemical or optical or acoustic signals or any other signals, and / or any combination thereof) to a target site as a nerve or muscle; a power source that communicates with the electrode via wired or wireless communication; and a controller that communicates with the electrode and is programmed to direct the delivery of electrical or other signals through the electrode to the target site in order to improve a patient's sleep-disordered breathing.

[0051] The delivery of neural regulatory signals can improve sleep-disordered breathing in patients.

[0052] Neuromodulation can also be applied to other disease states, such as central sleep apnea, sleep disorders, dry mouth, dysphagia, hypertension, hypotension, autonomic dysfunction, heart rate regulation, blood pressure regulation, migraine, headache, acute pain, chronic pain, neuropathic pain, muscle pain, superficial pain, skin pain, back pain, menstrual pain, mental disorders, epilepsy, epileptic seizures, movement disorders, Parkinson's disease, tremor, hemiparesis, paralysis, synkinesis, spasticity, dystonia, autoimmune diseases of the central nervous system, autoimmune diseases of the peripheral nervous system, autoimmune diseases of the autonomic nervous system, inflammatory diseases of the central nervous system, inflammatory diseases of the peripheral nervous system, inflammatory diseases of the autonomic nervous system, visual impairment, hearing impairment, mental disorders, mood disorders, insomnia, parasomnia, primary peripheral nervous system diseases, secondary peripheral nervous system diseases, primary central nervous system diseases, secondary central nervous system diseases, muscle dysfunction, neuromuscular dysfunction, urinary dysfunction, intestinal dysfunction, anorectal dysfunction, constipation, and hearing impairment. Force loss, tinnitus, cranial nerve disorders, vestibular dysfunction, hormonal regulation, trauma including peripheral and central nervous system disorders, cognitive impairment, dementia, neuropsychiatric disorders, exocrine dysfunction, endocrine dysfunction, neurotransmitter regulation, cardiac pacing, arrhythmia, irregular heart rhythm, tachyarrhythmia, bradycardia, tachycardia, bradycardia, nasal diseases, sinus diseases, nasal cavity and sinus diseases, inflammatory nasal diseases, inflammatory sinus diseases, inflammatory nasal cavity and sinus diseases, rhinitis, rhinosinusitis, allergic rhinitis, non-allergic rhinitis Rhinitis, chronic rhinitis, acute rhinitis, acute sinusitis, recurrent acute sinusitis, chronic sinusitis, acute rhinosinusitis, recurrent acute rhinosinusitis, chronic rhinosinusitis, olfactory dysfunction, hearing loss, hearing impairment, Eustachian tube dysfunction, middle ear dysfunction, external ear dysfunction, inner ear dysfunction, vestibular-cochlear dysfunction, balance disorder, swallowing disorder, taste disorder, salivary secretion disorder, voice disorder, speech disorder, tumor, malignant tumor, benign disease, cancer, sarcoma, and / or any other condition that may be affected by neural regulation and / or any combination thereof. The foregoing is merely a few examples of conditions for which neural regulation may be beneficial; however, the embodiments of the invention described below are not necessarily limited to treating only the aforementioned conditions.

[0053] Therefore, the methods and systems disclosed herein can be improvements for the treatment of sleep-disordered breathing and / or neural modulation.

[0054] 2. Neural Modulation Examples

[0055] Neuromodulation has the potential to treat a wide range of physiological conditions, disorders, and diseases. Neuromodulation refers to alterations in the electrical and chemical activity of the nervous system, including the central, peripheral, and autonomic nervous systems. Such alterations can include activation, inhibition, stimulation, modification, regulation, and / or any combination thereof. By altering this activity, a variety of effects can be achieved. For example, motor nerves can be stimulated to induce muscle contraction. Sensory nerves can be activated to provide sensory feedback to organs and / or patients, and / or inhibited to alleviate pain or other sensory functions. Autonomic nervous systems can be modulated to regulate involuntary voluntary physiological functions such as heart rate, blood pressure, respiration, digestive function, thermoregulation, reflex regulation, bladder and bowel function, sexual function, exocrine function, endocrine function, paracrine function, neuromuscular function, neuromuscular junction function, neurotransmitter release, neurotransmitter inhibition, neurotransmitter regulation, mucosal function, skin or epidermal function, inflammation, allergic inflammation, non-allergic inflammation, acute inflammation, chronic inflammation, cellular function, cell communication, and / or any combination thereof. It can also modulate the nervous system to regulate exocrine, endocrine, and paracrine functions, such as hormone secretion, enzyme secretion, protein secretion, metabolic regulation, growth and development control, maintenance of fluid and electrolyte balance, regulation of reproductive processes, regulation of stress responses, blood glucose control, sweat production and secretion, lubrication, saliva production and secretion, mucus production and secretion, waste excretion, mucosal function, vasoconstriction, vasodilation, neurotransmitter regulation, neurotransmitter release, neurotransmitter inhibition, chemical regulation, chemical release, chemical inhibition, hormone release, hormone regulation, hormone inhibition, inflammation, allergic inflammation, non-allergic inflammation, acute inflammation, chronic inflammation, cell function, cell communication, lacrimal production, and lactation. While the embodiments of this disclosure can be disclosed for use in patients with specific conditions, these embodiments can be used in conjunction with any patient / body part where neuromodulation may be desired.

[0056] This disclosure relates to methods and systems for treating patients with sleep-disordered breathing by neurally modulating and activating the muscles of the palate and pharynx. This disclosure also relates to methods and systems for treating patients with sleep-disordered breathing by neurally modulating and activating the muscles of the palate and pharynx, as well as the tongue and girdle muscles and / or any combination thereof. Sleep-disordered breathing includes snoring, sleep apnea, upper airway resistance syndrome, hypoventilation syndrome, and obesity hypoventilation syndrome. Sleep apnea includes obstructive sleep apnea, central sleep apnea, and mixed sleep apnea.

[0057] Referring to “improving” a patient’s SDB includes treating, alleviating, mitigating, or preventing SDB. In some respects, approaches to improving a patient’s SDB are inherently preventative rather than reactive. In other words, approaches to improving a patient’s SDB, according to some aspects, involve preventing SDB, rather than detecting events such as apnea or hypopnea and responding to such detected events. By preventing SDB, treatments reduce the likelihood of airway collapse, rather than responding to recorded events. In other aspects, improving a patient’s SDB can consist of responding to respiratory events such as apnea or hypopnea. As used herein, “modulation,” “neural modulation,” “neuromodulation,” “neuromodulate,” “neurostimulation,” “neuro-stimulate,” “stimulation,” or “stimulate” refers to the stimulation or inhibition or activation, or stimulation, modification, or regulation of neural activity. Patients with SDB include mammals, such as humans.

[0058] Multiple mechanisms contribute to obstruction and airflow limitation in sleep apnea, including anatomical and physiological factors. Anatomical factors include soft tissue and craniofacial anatomy, airway volume, and tissue collapse. Physiological factors include neuromuscular control, circuit gain, and arousal threshold. A key mechanism for airflow limitation is weakened neuromuscular control in the upper airway muscles, leading to intermittent and recurrent airway collapse and obstruction. Without treatment, OSA can affect daytime sleepiness and function, and raise cardiovascular, metabolic, and stroke risks.

[0059] Continuous positive airway pressure (CPAP) is the gold standard first-line treatment for all phenotypes of OSA. It is highly effective for patients who adhere to CPAP therapy, but up to 50% of patients do not adhere to it. Surgical options are available for patients who are intolerant to CPAP therapy seeking disease remission; however, not all phenotypes of OSA are well treated surgically. A specific phenotype is complete concentric palatine collapse (CCCp), characterized by frequent complete collapse of the posterior palatine and lateral palatopharyngeal walls. It affects up to 30% of OSA patients and is associated with greater disease severity (more frequent and severe airway collapses) and a higher propensity for CPAP failure. Modern upper airway surgery and neurostimulation techniques are only partially effective in treating CCCp. Contemporary neurostimulation methods have focused on the hypoglossal nerve (which is contraindicated in CCCp patients) and more recently on the cervical loop nerve. Other anatomical phenotypes, sites, and patterns of airway collapse include anteroposterior, lateral, and concentric collapses of the nasopharynx, soft palate, uvula, and oropharynx (including the lateral pharyngeal walls, tonsils, posterior pharyngeal walls, tongue, root of tongue, hypopharynx, hyoid bone, larynx, epiglottis, supraglottic, glottic, and subglottic).

[0060] Modern neurostimulation methods for sleep apnea target the genioglossus muscle, the largest airway dilator, which causes tongue protrusion, increases airway volume, or prevents posterior collapse and improves airflow. Neck loop stimulation has been proposed to address lateral wall muscle collapse through activation of the subhyoid band muscle, caudal tracheal traction and reinforcement of the pharyngeal lateral wall, thereby preventing or reversing lateral wall collapse, increasing airway volume, and improving airflow. However, concentric airway collapse (a combination of oropharyngeal / palatopharyngeal lateral wall collapse and anterior / posterior oropharyngeal / palatopharyngeal collapse) occurs independently of these mechanisms, and no neurostimulation methods have been proposed or explored in this field that directly target this neglected mechanism. Furthermore, the current paradigm of thought in this field focuses on activating airway muscle tissue during obstruction periods to increase airway diameter, thereby reversing airway collapse. This paradigm assumes that initiating neuromuscular activation by providing external neuromodulation to the airway dilator during the inspiratory phase is the primary mechanism that can be used to treat airway collapse. However, pre-inspiratory and pre-expiratory activation of airway dilators and other airway muscles can also prevent airway collapse, thus maintaining pharyngeal airflow and lung ventilation during periods of negative pressure and pharyngeal collapse. Furthermore, the role of airway muscles in preventing or partially or completely controlling the collapse of rigid or sub-rigid airways, and which are not considered typical airway dilators by experts in the field, has not been investigated.

[0061] In one embodiment, a method and system for treating sleep-disordered breathing may be provided to a patient following: polysomnography for diagnosis of sleep-disordered breathing; anatomical assessment, such as radiological examination and / or endoscopy and / or pharmacokinetic endoscopy and / or awake endoscopy and / or laboratory examination and / or physiological examination and / or any technical examination; screening methods for sleep-disordered breathing; clinical suspicion of sleep-disordered breathing, including a history of symptoms and signs of sleep-disordered breathing; and / or physical examination findings suggestive of sleep-disordered breathing, including oral examination, oral and / or nasal cavity and / or nasopharynx and / or oropharynx and / or hypopharynx and / or tongue and / or tongue root and / or supraglottic and / or glottic and / or subglottic endoscopy, neck examination, craniofacial examination, facial bone examination, airway examination, dental examination and / or any other method for screening and / or diagnosing sleep-disordered breathing; and / or any combination thereof. In one embodiment, methods and systems for sleep-disordered breathing can be provided to patients by healthcare practitioners such as physicians and / or surgeons and / or dentists and / or oral health practitioners and / or oral hygienists and / or dental assistants and / or nurses and / or any healthcare provider.

[0062] In one embodiment, methods and systems for treating sleep-disordered breathing may be provided as, in combination with, or incorporated thereof: a retainer, and / or a non-retainer form, and / or a brace form, and / or a non-implantable form, and / or an implantable form, and / or positive airway pressure therapy and / or continuous positive airway pressure therapy and / or mandibular advancement device and / or mandibular advancement therapy and / or mandibular advancement procedure and / or mandibular advancement surgery, and / or surgery for sleep-disordered breathing (including nasal surgery and / or nasopharyngeal surgery, and / or oral surgery and / or oropharyngeal surgery and / or palatal surgery and / or tonsil surgery and / or pharyngeal lateral wall surgery and / or pharyngeal surgery and / or oropharyngeal surgery and / or hypopharyngeal surgery and / or tongue surgery and / or tongue base surgery). Surgery and / or supraglottic surgery and / or epiglottic surgery and / or glottic surgery, and / or subglottic surgery and / or craniofacial surgery and / or facial bone surgery and / or hyoid bone surgery and / or dental surgery and / or neck surgery and / or minimally invasive procedures and / or non-invasive procedures), postural therapy and / or devices and / or medications, orthodontic therapy and / or devices and / or medications and / or procedures and / or surgery, dental therapy and / or devices and / or retainers and / or prostheses and / or medications and / or procedures and / or surgery, endodontic therapy and / or devices and / or retainers and / or prostheses and / or medications and / or procedures and / or surgery, sleep therapy and / or devices and / or retainers and / or prostheses and / or medications and / or procedures and / or surgery, sleep disorder therapy and / or devices and / or Retainers and / or prostheses and / or medications and / or procedures and / or surgery; dental braces and / or appliances and / or retainers and / or prostheses; bruxism therapy and / or devices and / or retainers and / or prostheses and / or medications and / or procedures and / or surgery; nasal therapy and / or devices and / or prostheses and / or medications; nasopharyngeal therapy and / or devices and / or prostheses and / or medications; nasal airway therapy and / or devices and / or retainers and / or prostheses and / or medications and / or procedures and / or surgery; oral therapy and / or devices and / or prostheses and / or retainers and / or medications; oropharyngeal therapy and / or devices and / or prostheses and / or medications; palatal therapy and / or devices and / or prostheses and / or medications; tonsil therapy and / or devices and / or / or prostheses and / or medications, pharyngeal wall therapy and / or devices and / or prostheses and / or medications, hypopharyngeal therapy and / or devices and / or prostheses and / or medications, tongue therapy and / or devices and / or prostheses and / or medications, tongue base therapy and / or devices and / or prostheses and / or medications, supraglottic therapy and / or devices and / or prostheses and / or medications, epiglottic therapy and / or devices and / or prostheses and / or medications, and / or glottic therapy and / or devices and / or prostheses and / or medications, subglottic therapy and / or devices and / or prostheses and / or medications, craniofacial therapy and / or devices and / or prostheses and / or medications, facial bone therapy and / or devices and / or prostheses and / or medications, and / or dental therapy and / or devices and / or retainers and / or prostheses and / or medications.Neck therapies and / or devices and / or retainers and / or prostheses and / or medications, and / or non-invasive therapies and / or devices and / or prostheses and / or medications, neuromodulation therapies and / or devices and / or prostheses and / or medications and / or procedures and / or surgeries and / or methods and / or systems, trigeminal nerve therapies and / or devices and / or medications and / or procedures and / or surgeries and / or methods and / or systems, hypoglossal nerve stimulation therapies and / or devices and / or prostheses and / or medications and / or procedures and / or surgeries and / or methods and / or Systems, cervical loop nerve stimulation therapy and / or devices and / or prostheses and / or drugs and / or procedures and / or surgeries and / or methods and / or systems; glossopharyngeal nerve stimulation therapy and / or devices and / or prostheses and / or drugs and / or procedures and / or surgeries and / or methods and / or systems; vagus nerve stimulation therapy and / or devices and / or prostheses and / or drugs and / or procedures and / or surgeries and / or methods and / or systems; facial nerve therapy and / or devices and / or drugs and / or procedures and / or surgeries and / or methods and / or systems Systematic and accessory nerve stimulation therapy and / or devices and / or prostheses and / or drugs and / or procedures and / or surgeries and / or methods and / or systems; cranial nerve stimulation therapy and / or devices and / or prostheses and / or drugs and / or procedures and / or surgeries and / or methods and / or systems; peripheral nerve and / or nervous system nerve stimulation therapy and / or devices and / or prostheses and / or drugs and / or procedures and / or surgeries and / or methods and / or systems; central nervous system therapy and / or devices and / or prostheses and / or drugs and / or procedures. This includes and / or surgical and / or method and / or system treatments, autonomic nervous system therapies and / or devices and / or prostheses and / or drugs and / or procedures and / or surgical and / or method and / or system treatments, trigeminal nerve stimulation therapies and / or devices and / or prostheses and / or drugs and / or procedures and / or surgical and / or method and / or system treatments, and / or any therapy and / or device and / or prosthesis and / or drug and / or procedure and / or surgical and / or method and / or system intended to treat sleep-disordered breathing, and / or any combination thereof. The foregoing is merely a few examples of therapies and / or devices and / or prostheses and / or drugs and / or procedures and / or surgical and / or method and / or system treatments for sleep-disordered breathing; however, the embodiments of the invention described below are not necessarily limited to the above-described therapies and / or devices and / or prostheses and / or drugs and / or procedures and / or surgical and / or method and / or system treatments, and / or any combination thereof.

[0063] In one embodiment, after providing a method and system for treating sleep-disordered breathing, the effectiveness of the method and system can be evaluated by the aforementioned polysomnography, radiological examination, endoscopy, pharmacokinetic endoscopy, awake endoscopy, clinical history and / or examination, laboratory tests, technical examination, and / or any of the aforementioned examinations, and / or any combination thereof. Following the aforementioned examinations for evaluating the effectiveness of the method and system for treating sleep-disordered breathing, neural modulation parameters can be titrated based on information obtained from the aforementioned examinations and / or information generated and / or detected and / or sensed and / or stored and / or provided by the system for treating sleep-disordered breathing.

[0064] In one embodiment, improvement in a patient's sleep-disordered breathing can be represented by increased airway volume, reduced airway obstruction, increased airway patency, decreased critical closure pressure of the pharynx and / or palate, increased opening pressure of the pharynx and / or palate, decreased airway tissue collapse, decreased airway muscle collapse, increased pharyngeal airflow, increased pulmonary ventilation, decreased apnea frequency, decreased hypopnea frequency, decreased apnea-hypopnea index, increased oxygen desaturation index, increased minimum oxygen saturation, reduced hypoxic time, reduced relative hypoxic time, reduced hypercapnia, improved sleep quality, improved sleep efficiency, improved sleep quality, improved daytime sleepiness, improved snoring, decreased awakening frequency, increased total sleep time, reduced awakenings after falling asleep, and improved sleep stages. Improved REM sleep, improved non-REM sleep, improved REM latency, reduced central apnea frequency, increased mixed apnea frequency, improved number of respiratory events, improved supine breathing events, improved lateral breathing events, improved prone breathing events, improved any sleep quality indicator, improved any sleep disorder, improved any sleep disturbance, reduced cardiovascular risk, reduced cerebrovascular risk, reduced metabolic risk, improved sleep latency, reduced respiratory effort-related arousal, improved circadian rhythm function, improved any polysomnography parameter, improved any non-polysomnography parameter, improved any sleep quality metric, improved nasal function, improved sinus function, improved nasal cavity and sinus function, and / or any health benefits, and / or any combination thereof.

[0065] This disclosure relates to methods and systems for treating patients with sleep-disordered breathing by activating the palatal and pharyngeal muscle tissues through neural modulation. The palatal and pharyngeal muscle tissues are innervated by branches of the trigeminal nerve (mandibular [V2] and maxillary [V3] branches) and the pharyngeal plexus (a network of cranial nerve fibers from the cranial roots of the accessory nerve, the vagus nerve, and the glossopharyngeal nerve). The maxillary branch of the trigeminal nerve has multiple branches, including the lesser palatine nerve (LPN) which innervates the muscles of the palatal sling, including the levator palatine veli palatine (LVP), uvula (MU), palatopharyngeal (PP), and palatoglossal (PG) muscles. These muscles respectively elevate the soft palate (LVP), retract the uvula anteriorly (MU), and tighten the lateral pharyngeal walls caudally (PP, PG).

[0066] The mandibular branch of the trigeminal nerve has multiple branches, including the tensor veli palatini (TVP) nerve, which innervates the tensor veli palatini muscle. This muscle pulls the soft palate laterally.

[0067] The pharyngeal plexus (a network of cranial nerve fibers from the cranial root of the accessory nerve, the vagus nerve, and the glossopharyngeal nerve) has multiple branches to the muscles of the palate and pharynx, including branches to the levator palatineis muscle, the palatopharyngeal muscle, the palatoglossus muscle, the superior constrictor (SC) muscle, and the middle constrictor (MC) muscle. These muscles respectively elevate the soft palate (LVP), tighten the lateral walls of the pharynx caudally (PP, PG), and increase circumferential tension of the pharynx (SC, MC).

[0068] The tongue is composed of both intrinsic and extrinsic muscles. The intrinsic muscles include the upper longitudinal, lower longitudinal, transverse, and vertical muscles. The upper and lower longitudinal muscles shorten and widen the tongue, the transverse muscles lengthen and narrow the tongue, and the vertical muscles flatten the tongue. The extrinsic muscles include the genioglossus, styloglossus, hyoidlossus, and palatoglossus. The genioglossus protrudes the tongue, the styloglossus and hyoidlossus retract the tongue and respectively raise and lower the lateral edges of the tongue, and the palatoglossus pulls the palate towards the back of the tongue.

[0069] To avoid being bound by a specific mechanism of action, stimulation of the nerves innervating these muscles, as well as the muscles themselves, can congruently tighten the caudal lateral walls to prevent collapse of the anterior and posterior palates and increase circumferential tension in the pharynx for circumferential expansion and to prevent collapse of the velopharynx and oropharynx. Furthermore, stimulation can assist in preventing the tongue from collapsing backward into the pharynx by actively protruding the tongue or by increasing neuromuscular tension to inhibit tongue collapse during inspiration. Therefore, neuromodulation of the nerves innervating these muscles and / or the muscles themselves can be a novel treatment for OSA patients, particularly those with CCCp and multi-level airway obstruction. This stimulation can be delivered via electrical, ultrasonic, magnetic, radiofrequency, mechanical, chemical, optical, or acoustic energy, and / or any combination thereof. The stimulation can be unilateral or bilateral. The foregoing are merely a few examples of the effects of neuromodulation on sleep-disordered breathing; however, the embodiments of the invention described below are not necessarily limited to the aforementioned effects.

[0070] Not wishing to be limited to a particular embodiment, the therapeutic delivery system may be placed inside the oral cavity and / or nasal cavity and / or oropharynx and / or nasopharynx, and may consist of: at least one electrode configured to deliver electrical or other signals to a target site that is, as described above, a nerve or muscle; a power source that communicates wirelessly with the electrode; and a controller that communicates with the electrode and is programmed to direct the delivery of electrical or other signals through the electrode to the target site. The foregoing descriptions are merely a few examples of therapeutic delivery sleep systems for sleep-disordered breathing; however, the embodiments of the invention described below are not necessarily limited to the above embodiments.

[0071] Without wishing to be limited to a particular embodiment, the methods and systems for treating sleep-disordered breathing can be closed-loop systems, open-loop systems, and / or any combination thereof. In one embodiment, the method and system for treating sleep-disordered breathing may be configured to achieve their therapeutic effect using the following: polysomnography data; and / or data from anatomical assessments, such as radiological examinations and / or endoscopic examinations and / or pharmacologically induced endoscopy and / or awake endoscopy and / or laboratory examinations and / or physiological examinations and / or any technical examinations; clinical suspicion of sleep-disordered breathing, including a history of symptoms and signs of sleep-disordered breathing; and / or physical examination findings suggestive of sleep-disordered breathing, including oral examination, oral and / or nasal cavity and / or nasopharynx and / or oropharynx and / or hypopharynx and / or tongue and / or tongue root and / or supraglottic and / or glottic and / or subglottic endoscopy, neck examination, craniofacial examination, facial bone examination, airway examination, dental examination, and / or any other methods for screening and / or diagnosing sleep-disordered breathing; and / or any data relating to sleep physiology and / or sleep disorders and / or sleep disorder pathophysiology; and / or any of the foregoing examinations; and / or any combination thereof. In one embodiment, the closed-loop system comprises: sensing and / or measuring and / or monitoring physiological parameters and / or surrogates of sleep and / or sleep apnea and / or breathing; processing data from these parameters and / or surrogates; or directly controlling neural stimulation and transmitting signals to electrodes to stimulate target anatomical structures. In another embodiment, the open-loop system comprises configuring neural stimulation parameters based on: polysomnography data; and / or data from home sleep studies; and / or data from another form of sleep study; and / or data from anatomical assessments (such as radiological examinations and / or endoscopy and / or pharmacologically induced endoscopy and / or awake endoscopy and / or laboratory tests and / or physiological examinations and / or any technical examination and / or any of the foregoing examinations); and / or any combination thereof. In this embodiment, the neural stimulation parameters may be titrated and / or adjusted and / or optimized by the patient and / or physician and / or surgeon and / or dentist and / or nurse and / or healthcare practitioner and / or any combination thereof to provide customized neural stimulation therapy for each patient.

[0072] In one embodiment, the method and system for treating sleep-disordered breathing can be activated by a patient and / or a physician and / or a surgeon and / or a dentist and / or a nurse and / or a healthcare practitioner and / or any combination thereof. In one embodiment, the method and system for treating sleep-disordered breathing can be activated by an algorithm consisting of inputs from location data, timing inputs, sleep architecture data, anatomical data, and physiological sleep parameters and / or any combination thereof.

[0073] Not wishing to be limited to a particular embodiment, at least one electrode may be placed inside or beneath the mucous membrane, skin or skin layer, muscle, nerve or nerve fiber, blood vessel, soft tissue (including tendons and / or ligaments and / or fascia and / or lymph nodes and / or adipose tissue), and / or any combination thereof, close to a target that is the aforementioned nerve or muscle; a power source that communicates wirelessly with the electrode; and a controller that communicates with the electrode and is programmed to direct the delivery of electrical signals and / or other signals through the electrode to the target site. The foregoing is merely a few examples of a sleep delivery system for the treatment of sleep-disordered breathing; however, the embodiments of the invention described below are not necessarily limited to the above embodiments.

[0074] In one embodiment, at least one electrode may be deployed to the target site via transmucosal / transmucosal and / or percutaneous delivery and / or any combination thereof. In one embodiment, the electrode may be deployed to the target site via a needle delivery system and / or a catheter delivery system and / or an inserter delivery system and / or a sheath delivery system and / or a dilator delivery system and / or a guidewire delivery system and / or a balloon catheter delivery system, and / or a stent delivery system and / or a microcatheter delivery system and / or an image-guided delivery system, and / or an endoscope delivery system and / or an optical delivery system and / or any system that facilitates delivery and / or any combination thereof.

[0075] Not wishing to be limited to a particular embodiment, methods and systems for treating sleep-disordered breathing may be delivered in the following forms: retainer, and / or non-retainer form, and / or brace form, and / or non-implantable form, and / or implantable form, and / or continuous positive airway pressure therapy and / or mandibular advancement device and / or mandibular advancement therapy and / or mandibular advancement procedure and / or mandibular advancement surgery, and / or surgery for sleep-disordered breathing (including nasal surgery and / or nasopharyngeal surgery, and / or oral surgery and / or oropharyngeal surgery and / or palatal surgery and / or tonsil surgery and / or pharyngeal lateral wall surgery, and / or hypopharyngeal surgery and / or tongue surgery, and / or tongue base surgery and / or supraglottic surgery and / or epiglottic surgery and / or glottic surgery, and / or subglottic surgery). Surgery and / or craniofacial surgery and / or facial bone surgery and / or hyoid bone surgery and / or dental surgery and / or neck surgery and / or non-invasive procedures), postural therapy and / or devices and / or medications, orthodontic therapy and / or devices and / or medications and / or procedures and / or surgery, dental therapy and / or devices and / or retainers and / or prostheses and / or medications and / or procedures and / or surgery, endodontic therapy and / or devices and / or retainers and / or prostheses and / or medications and / or procedures and / or surgery, sleep therapy and / or devices and / or retainers and / or prostheses and / or medications and / or procedures and / or surgery, sleep disorder therapy and / or devices and / or retainers and / or prostheses and / or medications and / or procedures and / or surgery, dental prosthetic devices and / or appliances and / or retainers and / or... Or prostheses, bruxism treatment and / or devices and / or retainers and / or prostheses and / or medications and / or procedures and / or surgery, nasal treatment and / or devices and / or prostheses and / or medications, and / or nasopharyngeal treatment and / or devices and / or prostheses and / or medications, nasal airway treatment and / or devices and / or retainers and / or prostheses and / or medications and / or procedures and / or surgery, and / or oral treatment and / or devices and / or prostheses and / or retainers and / or medications, oropharyngeal treatment and / or devices and / or prostheses and / or medications, and / or palatal treatment and / or devices and / or prostheses and / or medications, tonsil treatment and / or devices and / or prostheses and / or medications, pharyngeal lateral wall treatment and / or devices and / or prostheses and / or medications, hypopharyngeal treatment and / or devices and / or prostheses And / or drugs, tongue therapy and / or devices and / or prostheses and / or drugs, tongue root therapy and / or devices and / or prostheses and / or drugs, supraglottic therapy and / or devices and / or prostheses and / or drugs, epiglottic therapy and / or devices and / or prostheses and / or drugs, glottic therapy and / or devices and / or prostheses and / or drugs, subglottic therapy and / or devices and / or prostheses and / or drugs, craniofacial therapy and / or devices and / or prostheses and / or drugs, facial bone therapy and / or devices and / or prostheses and / or drugs, and / or dental therapy and / or devices and / or retainers and / or prostheses and / or drugs, neck therapy and / or devices and / or retainers and / or prostheses and / or drugs, and / or non-invasive therapy and / or devices and / or prostheses and / or drugs.Neuromodulation therapy and / or device and / or prosthesis and / or drug and / or procedure and / or surgery and / or method and / or system; Trigeminal nerve therapy and / or device and / or drug and / or procedure and / or surgery and / or method and / or system; Hypoglossal nerve stimulation therapy and / or device and / or prosthesis and / or drug and / or procedure and / or surgery and / or method and / or system; Cervical loop nerve stimulation therapy and / or device and / or prosthesis and / or drug and / or procedure and / or surgery and / or methods and / or systems, glossopharyngeal nerve stimulation therapy and / or devices and / or prostheses and / or drugs and / or procedures and / or surgeries and / or methods and / or systems, vagus nerve stimulation therapy and / or devices and / or prostheses and / or drugs and / or procedures and / or surgeries and / or methods and / or systems, facial nerve therapy and / or devices and / or drugs and / or procedures and / or surgeries and / or methods and / or systems, accessory nerve stimulation therapy and / or devices and / or prostheses and / or drugs And / or procedures and / or surgeries and / or methods and / or systems, cranial nerve stimulation therapy and / or devices and / or prostheses and / or drugs and / or procedures and / or surgeries and / or methods and / or systems, peripheral nerve and / or nervous system nerve stimulation therapy and / or devices and / or prostheses and / or drugs and / or procedures and / or surgeries and / or methods and / or systems, central nervous system therapy and / or devices and / or prostheses and / or drugs and / or procedures and / or surgeries and / or methods and / or systems, autonomic nervous system therapy and / or devices and / or prostheses and / or drugs and / or procedures and / or surgeries and / or methods and / or systems, trigeminal nerve stimulation therapy and / or devices and / or prostheses and / or drugs and / or procedures and / or surgeries and / or methods and / or systems, and / or any therapy and / or device and / or prosthesis and / or drug and / or procedure and / or surgery and / or method and / or system designed to treat sleep-disordered breathing, and / or any combination thereof. The foregoing descriptions are merely a few examples of therapies and / or devices and / or prostheses and / or drugs and / or procedures and / or surgeries and / or methods and / or systems for treating sleep-disordered breathing. However, the embodiments of the present invention described below are not necessarily limited to the aforementioned therapies and / or devices and / or prostheses and / or drugs and / or procedures and / or surgeries and / or methods and / or systems, and / or any combination thereof.

[0076] Not wishing to be limited to specific embodiments, methods and systems for treating sleep-disordered breathing can modulate the proximal origin of a nerve and / or its foramen and / or its branches and / or its branches and / or its distal components and / or its distal ends and / or its fibers and / or its motor endplates and / or its spinal roots and / or its brainstem roots and / or its central nervous system origin and / or its neuromuscular junctions and / or the muscles it innervates and / or its sensory fibers and / or its motor fibers and / or its autonomic fibers and / or its ganglia and / or its axons and / or any peripheral and / or central and / or autonomic nervous system components, and / or any combination thereof. Not wishing to be limited to specific embodiments, methods and systems for treating sleep-disordered breathing can modulate any physiological and / or chemical and / or electrical and / or neurochemical and / or biological components, and / or any combination thereof, at their target sites.

[0077] Not wishing to be limited to a particular embodiment, in embodiments where an implantable receiver communicating with one or more implantable electrodes including a neurostimulator subsystem is present, the oral appliance subsystem may include a programmable pulse generator unit for transmitting power from the oral appliance subsystem to the implantable neurostimulator, such as inductive power transmission, radio frequency power transmission, or ultrasound power transmission. In this embodiment, the implantable neurostimulator may be delivered via a percutaneous delivery system comprising deployment to a target site via: a needle delivery system and / or a catheter delivery system and / or an inserter delivery system and / or a sheath delivery system and / or a dilator delivery system and / or a guidewire delivery system and / or a balloon catheter delivery system, and / or a stent delivery system and / or a microcatheter delivery system and / or an image-guided delivery system, and / or an endoscope delivery system and / or an optical delivery system and / or any system facilitating placement and / or surgical placement and / or any combination thereof. In this embodiment, a rechargeable battery in the oral appliance subsystem may be powered prior to use via wired or inductive power delivery from a charging cartridge and a remote subsystem. In this embodiment, the box and remote subsystem can also be used as a programming device that can be used to initiate, terminate, and regulate treatment delivered by the oral appliance and neurostimulator subsystem via a bidirectional wired or wireless telemetry link.

[0078] refer to Figure 1In one aspect, method 1 for treating a patient with sleep-disordered breathing includes delivering a neuromodulatory signal to a target site located near the lesser palatine nerve and / or the tensor veli palatini nerve and / or branches of the pharyngeal plexus to the levator veli palatini, palatopharynx, palatoglossus, mid-contractor, and / or superior contractor muscles, and / or any combination thereof. The target site may be located near the lesser palatine nerve and / or the tensor veli palatini nerve and / or branches of the pharyngeal plexus to the levator veli palatini, palatopharynx, palatoglossus, mid-contractor, and / or superior contractor muscles, and / or any combination thereof, such that delivering the neuromodulatory signal activates the motor fibers of these nerves and / or muscles. Method 1 further includes activating the levator veli palatini, and / or the uvula, and / or the palatopharynx, and / or the palatoglossus, and / or the tensor veli palatini, and / or the mid-contractor, and / or superior contractor, and / or any combination thereof. Method 1 further includes improving the patient's sleep-disordered breathing by delivering the neuromodulatory signal. The foregoing content are merely a few examples of neural modulation methods; however, the embodiments of the present invention described below are not necessarily limited to the methods described above.

[0079] refer to Figure 2 In one aspect, method 2 for treating a patient with sleep-disordered breathing includes delivering a neuromodulation signal to a target site adjacent to the levator veli palatini and / or the uvula and / or the palatopharynx and / or the palatoglossus and / or the tensor veli palatini and / or the middle and / or the superior and / or any combination thereof. The target site may be adjacent to the levator veli palatini and / or the uvula and / or the palatopharynx and / or the palatoglossus and / or the tensor veli palatini and / or the middle and / or the superior and / or any combination thereof, such that delivering the neuromodulation signal activates the muscle fibers of these muscles, thereby increasing their tension. Method 2 further includes improving the patient's sleep-disordered breathing by delivering the neuromodulation signal. The foregoing is merely a few examples of neuromodulation methods; however, the embodiments of the invention described below are not necessarily limited to the methods described above.

[0080] refer to Figure 3In one aspect, method 3 for treating patients with sleep-disordered breathing includes delivering neuromodulation signals to target sites near the lesser palatine nerve and / or the tensor veli palatine nerve, which innervates the muscles of the palate and / or pharynx, and / or to pharyngeal plexus branches of the levator veli palatine, palatopharynx, palatoglossus, middle and / or superior muscles and / or any combination thereof, and / or near target sites near the levator veli palatine and / or uvula and / or palatopharynx and / or palatoglossus and / or tensor veli palatine and / or middle and / or superior muscles and / or any combination thereof. The target site may be located near the lesser palatine nerve and / or the tensor veli palatine nerve and / or to branches of the pharyngeal plexus of the levator veli palatine, palatopharynx, palatoglossus, middle retractor and / or superior retractor and / or any combination thereof, and / or the levator veli palatine and / or the uvula and / or the palatopharynx and / or the palatoglossus and / or the tensor veli palatine and / or the middle retractor and / or the superior retractor and / or any combination thereof, such that delivering a neuromodulatory signal activates the motor fibers of these nerves and the muscle fibers of these muscles, thereby increasing their tone. Method 3 further includes improving sleep-disordered breathing in patients via delivering neuromodulatory signals. The foregoing is merely a few examples of neuromodulation methods; however, the embodiments of the invention described below are not necessarily limited to the methods described above.

[0081] refer to Figure 4 The muscles of the palate and pharynx are innervated by three nerves. It should be noted that... Figure 4 This section broadly illustrates most (if not all) of the known innervation of the palatine and pharyngeal muscles, but actual anatomical variations with all these branching patterns may not be present in a single patient. Normal anatomical variations may require the use of one or more different target sites in different patients to achieve the desired stimulation of the palatine and pharyngeal muscles. In some respects and reference... Figure 4Neural signals can be delivered to target sites near the lesser palatine nerve (LPN). In other aspects, neural signals can be delivered to target sites near the lesser palatine nerve in such a way that their proximity to the tensor veli palatine (TVP) muscle simultaneously activates the TVP muscle. In other aspects, neural signals can be delivered to target sites near the lesser palatine nerve in such a way that their proximity to the TVP muscle simultaneously activates the TVP muscle and / or fibers from branches of the pharyngeal plexus (Pplex-X, Pplex-IX) to the palatopharyngeal (PP) muscle, and / or fibers from branches of the pharyngeal plexus to the palatoglossal (PG) muscle, and / or fibers from branches of the pharyngeal plexus to the superior constrictor (SC) muscle, and / or fibers from branches of the pharyngeal plexus to the middle constrictor (MC) muscle, and / or fibers from branches of the pharyngeal plexus to the levator veli palatine (LVP) muscle are also stimulated. In other respects, neural modulation signals can be delivered to target sites near the lesser palatine nerve in such a manner that fibers adjacent to these nerves—from branches of the pharyngeal plexus to the palatopharyngeal muscle, and / or from branches of the pharyngeal plexus to the palatoglossus muscle, and / or from branches of the pharyngeal plexus to the superior constrictor muscle, and / or from branches of the pharyngeal plexus to the superior constrictor muscle, and / or from branches of the pharyngeal plexus to the levator veli palatini muscle—are also stimulated. The foregoing are merely a few examples of target sites for neural modulation; however, the embodiments of the invention described below are not necessarily limited to the aforementioned target sites.

[0082] refer to Figure 4In other respects, the neural modulation signal can be delivered to a target site near the lesser palatine nerve that activates the palatine and pharyngeal muscles, and / or the neural modulation signal can be delivered to a target site near the tensor veli palatini nerve that activates the tensor veli palatini muscle. In other respects, the neural modulation signal can be delivered to a target site near the lesser palatine nerve that activates the palatine and pharyngeal muscles, and / or the neural modulation signal can be delivered to a target site near the tensor veli palatini nerve that activates the tensor veli palatini muscle. In other respects, the neural modulation signal can be delivered to a target site near the lesser palatine nerve that activates the palatine and pharyngeal muscles, and / or the neural modulation signal can be delivered to a target site near the tensor veli palatini nerve that activates the tensor veli palatini muscle, and / or the neural modulation signal can be delivered to a target site near the tensor veli palatini muscle, and / or the neural modulation signal can be delivered to a target site near the branches of the pharyngeal plexus to the palatopharyngeal muscle and / or the palatoglossus muscle and / or the superior and / or the middle and / or the levator veli palatini muscle and / or any combination thereof. In other aspects, the neural modulation signal may be delivered to a target site near the lesser palatine nerve that activates the palatine and pharyngeal muscles, and / or the neural modulation signal may be delivered to a target site near the tensor veli palatini nerve that activates the tensor veli palatini muscle, and / or the neural modulation signal may be delivered to a target site near the branches of the pharyngeal plexus to the palatopharyngeal muscle and / or the palatoglossus muscle and / or the superior and / or the middle and / or the levator veli palatini muscle, or any combination thereof. In other aspects, the neural modulation signal may be delivered to a target site near the lesser palatine nerve that activates the palatine and pharyngeal muscles, and / or the neural modulation signal may be delivered to a target site near the tensor veli palatini muscle. In other aspects, the neural modulation signal may be delivered to a target site near the lesser palatine nerve that activates the palatine and pharyngeal muscles, and / or the neural modulation signal may be delivered to a target site near the tensor veli palatini muscle, and / or the neural modulation signal may be delivered to a target site near the branches of the pharyngeal plexus to the palatopharyngeal muscle and / or the palatoglossus muscle and / or the superior and / or the middle and / or the levator veli palatini muscle, and / or any combination thereof. In one embodiment, the neural modulation signal may be delivered to any combination of the branches of the pharyngeal plexus to the palatopharyngeal muscle and / or the palatoglossus muscle and / or the superior and / or the middle and / or the levator veli palatini muscle, and / or any combination thereof. Figure 4 Any of the neural and muscular anatomy structures represented herein can be activated to increase their tension. The foregoing is merely a few examples of target sites for neural modulation; however, the embodiments of the invention described below are not necessarily limited to the aforementioned target sites.

[0083] refer to Figure 5 The muscular tissue of the palate and pharynx consists of the levator veli palatini (LVP), uvula (MU), palatopharynx (PP), palatoglossus (PG), tensor veli palatini (TVP), middle constrictor (MC), and superior constrictor (SC). (In some respects and references) Figure 5Neural modulation signals can be delivered to target sites near the levator veli palatini, and / or the uvula, and / or the palatopharynx, and / or the palatoglossus, and / or the tensor veli palatini, and / or the middle retractor, and / or the superior retractor and / or any combination thereof. In other respects, neural modulation signals can be delivered to target sites near the levator veli palatini, and / or the uvula, and / or the palatopharynx, and / or the palatoglossus, and / or the tensor veli palatini, and / or the middle retractor, and / or the superior retractor and / or any combination thereof, such that they are near the lesser palatine nerve, and / or to the pharyngeal plexus branches of the levator veli palatini, and / or to the pharyngeal plexus branches of the palatoglossus, and / or to the pharyngeal plexus branches of the palatopharynx, and / or to the pharyngeal plexus branches of the superior retractor, and / or to the pharyngeal plexus branches of the middle retractor, and / or to the pharyngeal plexus branches of the levator veli palatini, and / or the tensor veli palatini nerve, and / or any combination thereof, such that these nerves can also be stimulated. In other respects, neural modulatory signals can be delivered to target sites near the levator veli palatini, and / or the uvula, and / or the palatopharynx, and / or the palatoglossus, and / or the tensor veli palatini, and / or the middle retractor, and / or the superior retractor and / or any combination thereof, such that they are near fibers of the lesser palatine nerve, and / or fibers to the pharyngeal plexus branches of the levator veli palatini, and / or fibers to the pharyngeal plexus branches of the palatoglossus, and / or fibers to the pharyngeal plexus branches of the palatopharynx, and / or fibers to the pharyngeal plexus branches of the superior retractor, and / or fibers to the pharyngeal plexus branches of the middle retractor, and / or fibers to the pharyngeal plexus branches of the levator veli palatini, and / or fibers to the tensor veli palatini, and / or any combination thereof, such that these nerve fibers can also be stimulated. In one embodiment, neural modulatory signals can be delivered in any combination to Figure 4 Any of the neural and muscular anatomy structures represented herein can be activated to increase their tension. The foregoing is merely a few examples of target sites for neural modulation; however, the embodiments of the invention described below are not necessarily limited to the aforementioned target sites.

[0084] refer to Figure 6In one aspect, method 4 for treating a patient with sleep-disordered breathing includes delivering neuromodulation signals to target sites in intrinsic muscles near the tongue, including longitudinal muscles, and / or transverse muscles, and / or vertical muscles, and / or any combination thereof. The target sites may be located near intrinsic muscles of the tongue, including longitudinal muscles, and / or transverse muscles, and / or vertical muscles, and / or any combination thereof, such that delivering the neuromodulation signals activates the muscle fibers of these muscles, thereby increasing their tension. Method 4 further includes improving the patient's sleep-disordered breathing by delivering neuromodulation signals. In another aspect, method 4 for treating a patient with sleep-disordered breathing includes delivering neuromodulation signals to target sites in extrinsic muscles near the tongue, including the genioglossus, and / or hyoidoglossus, and / or styloglossus, and / or any combination thereof. The target sites may be located near the genioglossus, and / or hyoidoglossus, and / or styloglossus, and / or any combination thereof, such that delivering the neuromodulation signals activates the muscle fibers of these muscles, thereby increasing their tension. Method 4 further includes improving the patient's sleep-disordered breathing by delivering neuromodulation signals. On the other hand, method 4 for treating a patient with sleep-disordered breathing includes delivering neuromodulation signals to target sites near intrinsic and / or extrinsic muscles of the tongue, including longitudinal muscles, and / or transverse muscles, and / or vertical muscles, and / or the genioglossus, and / or the hyoidoglossus, and / or the styloglossus, and / or any combination thereof. The target sites may be near longitudinal muscles, and / or transverse muscles, and / or vertical muscles, and / or the genioglossus, and / or the hyoidoglossus, and / or the styloglossus, and / or any combination thereof, such that delivering the neuromodulation signals activates the muscle fibers of these muscles, thereby increasing their tension. Method 4 further includes improving the patient's sleep-disordered breathing by delivering neuromodulation signals. The foregoing are merely a few examples of neuromodulation methods; however, the embodiments of the invention described below are not necessarily limited to the methods described above.

[0085] refer to Figure 7The tongue's muscular tissue consists of both intrinsic and extrinsic muscles. Intrinsic muscles include superior longitudinal, inferior longitudinal, transverse, and vertical muscles. Extrinsic muscles include the genioglossus, stylohyoidus, hyoidoglossus, and palatoglossus. In one aspect, method 5 for treating a patient with sleep-disordered breathing includes delivering a neuromodulatory signal to a target site near the intrinsic muscles of the tongue, which include longitudinal muscles and / or transverse muscles, and / or vertical muscles, and / or any combination thereof. The target site may be near the intrinsic muscles of the tongue, which include longitudinal muscles and / or transverse muscles, and / or vertical muscles, and / or any combination thereof, such that delivering the neuromodulatory signal activates the muscle fibers of these muscles, thereby increasing their tension. Method 5 further includes improving the patient's sleep-disordered breathing by delivering the neuromodulatory signal. In another aspect, method 5 for treating a patient with sleep-disordered breathing includes delivering a neuromodulatory signal to a target site near the extrinsic muscles of the tongue, which include the genioglossus, and / or hyoidoglossus, and / or stylohyoidus, and / or any combination thereof. The target site may be located near the genioglossus, and / or hyoidoglossus, and / or styloglossus, and / or any combination thereof, such that delivering a neuromodulatory signal will activate the muscle fibers of these muscles, thereby increasing their tension. Method 5 further includes improving the patient's sleep-disordered breathing by delivering a neuromodulatory signal. In another aspect, method 5 for treating a patient with sleep-disordered breathing includes delivering a neuromodulatory signal to a target site near the intrinsic and / or extrinsic muscles of the tongue, including longitudinal and / or transverse, and / or vertical, and / or genioglossus, and / or hyoidoglossus, and / or styloglossus, and / or any combination thereof. The target site may be located near the longitudinal and / or transverse, and / or vertical, and / or genioglossus, and / or hyoidoglossus, and / or styloglossus, and / or any combination thereof, such that delivering a neuromodulatory signal will activate the muscle fibers of these muscles, thereby increasing their tension. Method 5 further includes improving the patient's sleep-disordered breathing by delivering a neuromodulatory signal. The foregoing descriptions are merely a few examples of target sites for neural modulation; however, the embodiments of the invention described below are not necessarily limited to the aforementioned target sites.

[0086] refer to Figure 8In one aspect, method 6 for treating patients with sleep-disordered breathing includes: delivering neuromodulation signals to target sites of pharyngeal plexus branches near the lesser palatine nerve and / or the tensor veli palatine nerve and / or the levator veli palatine and / or the palatopharyngeal muscle and / or the palatoglossus muscle and / or the middle and / or the superior and / or any combination thereof, and / or delivering neuromodulation signals to target sites near the hypoglossal nerve innervating the genioglossus muscle and / or the loop nerve of the cervical spine innervating the band muscle and / or any combination thereof. The target site may be located near the lesser palatine nerve and / or the tensor veli palatini nerve and / or branches of the pharyngeal plexus to the levator veli palatini and / or the palatopharyngeal muscle and / or the palatoglossus muscle and / or the middle and / or the superior and / or any combination thereof, innervating the palatine and / or pharyngeal muscles, and / or delivering neuromodulation signals to the target site near the hypoglossal nerve innervating the genioglossus muscle and / or the loop nerve cervicis innervating the band muscles and / or any combination thereof, such that delivering the neuromodulation signal activates the motor fibers of these nerves. Method 6 further includes improving sleep-disordered breathing in a patient by delivering neuromodulation signals. Method 6 further includes activating the levator veli palatini and / or the uvula and / or the palatopharyngeal muscle and / or the palatoglossus muscle and / or the tensor veli palatini and / or the middle and / or the superior and / or the genioglossus muscle, and / or the band muscles, and / or any combination thereof. The foregoing is merely a few examples of neuromodulation methods; however, the embodiments of the invention described below are not necessarily limited to the methods described above.

[0087] In one aspect, a method for improving sleep-disordered breathing in a patient comprises delivering neuromodulatory signals (such as electrical or magnetic or ultrasonic or piezoelectric or radiation signals or electromagnetic signals or radio frequency or mechanical or chemical or optical or acoustic signals or any other signals, and / or any combination thereof) to target sites of the hypoglossal nerve, the cervical loop nerve, branches of the pharyngeal plexus to the palatopharyngeal muscle, branches of the pharyngeal plexus to the middle constrictor muscle, the sternothyroid muscle, the thyrohyoidohyoid muscle, the omohyoidohyoid muscle, the sternohyoidohyoid muscle, and / or any combination thereof, in order to improve the patient's sleep-disordered breathing.

[0088] refer to Figure 9In one aspect, method 7 for treating a patient with sleep-disordered breathing includes: delivering a neuromodulation signal to a target site near the levator veli palatini muscle, and / or the uvula muscle, and / or the palatopharyngeal muscle, and / or the palatoglossus muscle, and / or the middle retractor muscle, and / or the superior retractor muscle, and / or any combination thereof; and / or delivering a neuromodulation signal to a target site near the hypoglossal nerve innervating the genioglossus muscle and / or the loop nerve cervicalis innervating the stigmata muscle, and / or any combination thereof. The target site may be near the levator veli palatini muscle, and / or the uvula muscle, and / or the palatopharyngeal muscle, and / or the palatoglossus muscle, and / or the middle retractor muscle, and / or the superior retractor muscle, and / or the hypoglossal nerve innervating the genioglossus muscle, and / or the loop nerve cervicalis innervating the stigmata muscle, and / or any combination thereof, such that delivering the neuromodulation signal activates these muscles. Method 7 further includes improving the patient's sleep-disordered breathing by delivering the neuromodulation signal. Method 7 further includes activating the levator veli palatini and / or the uvula and / or the palatopharynx and / or the palatoglossus and / or the tensor veli palatini and / or the middle and / or the superior retractor muscles, and / or the genioglossus, and / or the band muscles, and / or any combination thereof. The foregoing is merely a few examples of neural modulation methods; however, the embodiments of the invention described below are not necessarily limited to the methods described above.

[0089] refer to Figure 10In one aspect, method 8 for treating patients with sleep-disordered breathing includes delivering neuromodulatory signals to target sites near the lesser palatine nerve and / or the tensor veli palatine nerve and / or branches of the pharyngeal plexus of the levator veli palatine, palatopharynx, palatoglossus, middle and / or superior muscles and / or any combination thereof, and / or near target sites near the levator veli palatine and / or uvula and / or palatopharynx and / or palatoglossus and / or tensor veli palatine and / or middle and / or superior muscles and / or any combination thereof, and / or near target sites near the intrinsic muscles of the tongue and / or extrinsic muscles of the tongue (including longitudinal muscles, and / or transverse muscles, and / or vertical muscles, and / or genioglossus, and / or hyoidoglossus, and / or styloglossus, and / or any combination thereof), such that the delivery of the neuromodulatory signals activates the motor fibers of these nerves and the muscle fibers of these muscles, thereby increasing their tension. The target site may be located near the lesser palatine nerve and / or the tensor veli palatine nerve and / or branches of the pharyngeal plexus to the levator veli palatine, palatopharynx, palatoglossus, middle retractor and / or superior retractor and / or any combination thereof, and / or the levator veli palatine and / or the uvula and / or the palatopharynx and / or the palatoglossus and / or the tensor veli palatine and / or the middle retractor and / or the superior retractor and / or any combination thereof, and / or the target site may be located near the intrinsic muscles of the tongue and / or the extrinsic muscles of the tongue (including longitudinal muscles, and / or transverse muscles, and / or vertical muscles, and / or the genioglossus, and / or the hyoidoglossus, and / or the styloglossus, and / or any combination thereof), such that delivering the neuromodulation signal will activate the motor fibers of these nerves and the muscle fibers of these muscles, thereby increasing their tone. Method 8 further includes improving sleep-disordered breathing in patients by delivering neuromodulation signals. The foregoing is merely a few examples of neuromodulation methods; however, the embodiments of the invention described below are not necessarily limited to the methods described above.

[0090] refer to Figure 11In one aspect, method 9 for treating patients with sleep-disordered breathing includes delivering neuromodulatory signals to target sites near the lesser palatine nerve and / or the tensor veli palatini nerve, which innervates the muscles of the palate and / or pharynx, and / or to pharyngeal plexus branches of the levator veli palatini, palatopharynx, palatoglossus, middle and / or superior muscles and / or any combination thereof, and / or near target sites near the levator veli palatini and / or uvula and / or palatopharynx and / or palatoglossus and / or tensor veli palatini and / or middle and / or superior muscles and / or any combination thereof, and / or near target sites near the hypoglossal nerve innervating the genioglossus, and / or the loop nerve cervicis innervating the band muscles, and / or any combination thereof, such that the delivery of the neuromodulatory signals activates the motor fibers of these nerves and the muscle fibers of these muscles, thereby increasing their tension. The target site may be located near the lesser palatine nerve and / or the tensor veli palatini nerve and / or branches of the pharyngeal plexus to the levator veli palatini, palatopharynx, palatoglossus, middle retractor and / or superior retractor and / or any combination thereof, and / or the levator veli palatini and / or the uvula and / or the palatopharynx and / or the palatoglossus and / or the tensor veli palatini and / or the middle retractor and / or the superior retractor and / or any combination thereof, and / or the target site may be located near the hypoglossal nerve innervating the genioglossus, and / or the loop nerve of the neck innervating the stigmata muscle, and / or any combination thereof, such that delivering neuromodulation signals activates the motor fibers of these nerves and the muscle fibers of these muscles, thereby increasing their tone. Method 9 further includes improving sleep-disordered breathing in patients by delivering neuromodulation signals. The foregoing is merely a few examples of neuromodulation methods; however, the embodiments of the invention described below are not necessarily limited to the methods described above.

[0091] refer to Figure 12In one aspect, method 10 for treating patients with sleep-disordered breathing includes delivering neuromodulation signals to target sites near the lesser palatine nerve and / or the tensor veli palatine nerve, which innervates the muscles of the palate and / or pharynx, and / or to branches of the pharyngeal plexus of the levator veli palatine, palatopharynx, palatoglossus, middle and / or superior muscles and / or any combination thereof, and / or near the levator veli palatine and / or uvula and / or palatopharynx and / or palatoglossus and / or tensor veli palatine and / or middle and / or superior muscles and / or any group thereof. The target sites, and / or target sites near the intrinsic muscles of the tongue and / or the extrinsic muscles of the tongue (including longitudinal muscles, and / or transverse muscles, and / or vertical muscles, and / or genioglossus, and / or hyoidoglossus, and / or styloglossus, and / or any combination thereof), and / or target sites near the hypoglossal nerve innervating the genioglossus, and / or the loop nerve of the neck innervating the band muscles, and / or any combination thereof, are such that the delivery of neuromodulatory signals activates the motor fibers of these nerves and the muscle fibers of these muscles, thereby increasing their tension. The target site may be close to the lesser palatine nerve and / or the tensor veli palatine nerve and / or branches of the pharyngeal plexus to the levator veli palatine, palatopharynx, palatoglossus, middle retractor and / or superior retractor and / or any combination thereof, and / or the levator veli palatine and / or the uvula and / or the palatopharynx and / or the palatoglossus and / or the tensor veli palatine and / or the middle retractor and / or the superior retractor and / or any combination thereof, and / or the target site may be close to the intrinsic muscles of the tongue and / or the extrinsic muscles of the tongue (including longitudinal muscles, and / or transverse muscles, and / or vertical muscles, and / or the genioglossus, and / or the hyoidoglossus, and / or the styloglossus, and / or any combination thereof), and / or the target site may be close to the hypoglossal nerve innervating the genioglossus, and / or the loop nerve of the neck innervating the band muscles, and / or any combination thereof, such that the delivery of the neuromodulatory signal will activate the motor fibers of these nerves and the muscle fibers of these muscles, thereby increasing their tension. Method 10 further includes improving the patient's sleep-disordered breathing by delivering neuromodulation signals. The foregoing are merely a few examples of neuromodulation methods; however, the embodiments of the invention described below are not necessarily limited to the methods described above.

[0092] refer to Figure 13In one embodiment, the neurostimulation system includes at least one electrode, a pulse generator, a battery, an oral appliance, a charger, and a remote control. In this embodiment, the oral appliance subsystem comprises at least one electrode, a pulse generator, a battery, and features allowing the oral appliance to be secured within the oral cavity. In this embodiment, the charger and remote control are packaged as another subsystem. In this embodiment, the charger powers the battery within the oral appliance. The battery powers the pulse generator, which is activated and transmits electrical or other pulses to at least one electrode based on neurostimulation parameters controlled by the remote control. The neurostimulation signal is transmitted via the electrodes to the affected anatomical target. In this embodiment, the electrodes may consist of one or more electrodes on each side of the oral appliance to deliver the neurostimulation signal. The foregoing is merely a few examples of embodiments of the neurostimulation system; however, the embodiments of the invention described below are not necessarily limited to the above embodiments.

[0093] refer to Figure 14 In one embodiment, the neurostimulation system includes at least one electrode, an antenna, a pulse generator, a rechargeable battery cell, an oral appliance, a charger, and a remote control. In this embodiment, the implantable electrode subsystem comprises one or more electrodes and an antenna or signal receiver for receiving wired or wireless signals. One or more implantable electrode subsystems may be present in the full neurostimulation system. In this embodiment, the oral appliance subsystem comprises a pulse generator, a battery, and features allowing the oral appliance to be secured within the oral cavity. In this embodiment, the charger and remote control are packaged as another subsystem. In this embodiment, the charger powers the battery within the oral appliance. The battery powers the pulse generator, which is activated and transmits signals and power to the implantable electrode subsystem based on neurostimulation parameters controlled by the remote control. The neurostimulation signal is transmitted via the electrodes to the affected anatomical target. In this embodiment, a delivery system can be used to implant the implantable electrode subsystem into multiple anatomical locations on both sides of the oral cavity to deliver the neurostimulation signal to the anatomical target. The foregoing descriptions are merely a few examples of embodiments of the neurostimulation system; however, the embodiments of the invention described below are not necessarily limited to the above embodiments.

[0094] refer to Figure 15 , Figure 16A and Figure 16BThe oral appliance subsystem may be a wearable device including features such as molding to the hard palate, molding to the mandible, conforming to the dentition, mechanically attaching to craniofacial anatomy (e.g., a wire in one embodiment), mechanically attaching to the oral cavity, pharynx, or nasal mucosa, adhering to the oral mucosa, and / or another attachment feature for securing the oral appliance to a patient near a target anatomical structure (e.g., in one embodiment, the lesser palatine nerve and / or the tensor veli palatine nerve, and / or to branches of the pharyngeal plexus to the levator veli palatine, palatopharynx, palatoglossus, medial retractor, and / or superior retractor). In embodiments where an implantable receiver communicating with one or more implantable electrodes including the neurostimulator subsystem is present, the oral appliance subsystem may include a programmable pulse generator unit for transmitting power from the oral appliance subsystem to the implanted neurostimulator, such as inductive power transmission, radio frequency power transmission, or ultrasonic power transmission. In this embodiment, the implantable neurostimulator can be delivered via a transmucosal / transmucosal and / or percutaneous delivery system, comprising deployment via catheters, cannulas, sheaths and / or other conduits, by injection, and / or by surgical placement and / or any other delivery method. In this embodiment, the rechargeable battery in the oral appliance subsystem can be powered prior to use via wired or inductive power delivery from the charging cassette and remote subsystem. In this embodiment, the cassette and remote subsystem can also serve as a programming device for initiating, terminating, and regulating treatment delivered by the oral appliance and neurostimulator subsystem via a bidirectional wired or wireless telemetry link.

[0095] refer to Figure 15 , Figure 16A and Figure 16BIn another embodiment, the oral appliance subsystem may consist of one or more electrodes, a programmable pulse generator, and a rechargeable battery. In this embodiment, one or more electrodes may be independently configured to target sites, including the lesser palatine nerve, and / or the tensor veli palatine nerve, and / or branches of the pharyngeal plexus to the levator veli palatine, palatopharyngeal, palatroglossal, mid-contractor, and / or superior contractor muscles, and / or any combination thereof. Additionally, the electrodes may be configured in an array to target the lesser palatine nerve, and / or the tensor veli palatine nerve, and / or branches of the pharyngeal plexus to the levator veli palatine, palatopharyngeal, palatroglossal, mid-contractor, and / or superior contractor muscles, and / or any combination thereof. Additionally, the electrodes may be configured in an array to target the levator veli palatine, tensor veli palatine, palatopharyngeal, palatroglossal, mid-contractor, superior contractor, and / or any combination thereof. Furthermore, at least one electrode may be configured in an array to target the aforementioned nerves innervating the palatine or pharyngeal muscles, and / or the aforementioned palatine or pharyngeal muscles, and / or any combination thereof. In this embodiment, the rechargeable battery in the oral appliance subsystem can be powered by wired or inductive power delivery from the charging box and remote subsystem before use. In this embodiment, the box and remote subsystem can also function as a programming device for initiating, terminating, and regulating treatment delivered by the oral appliance pulse generator via a bidirectional wired or wireless telemetry link. The foregoing are merely a few examples of embodiments of the neurostimulation system; however, the embodiments of the invention described below are not necessarily limited to the above embodiments.

[0096] refer to Figure 17The charging box and remote subsystem consist of a charging pad (tightly coupled electromagnetic resonant induction or non-radiative charging) and / or a charging bowl (loosely coupled or radiative electromagnetic resonant charging) and / or uncoupled radio frequency (RF) wireless charging and / or any combination thereof, to transfer energy from the charging box and remote subsystem to the oral appliance subsystem, while the oral appliance subsystem is docked within and / or on top of and / or near the electromagnetic field of the charging box and remote subsystem. The box and remote subsystem can also serve as a programming device for initiating, terminating, regulating, optimizing, and / or modulating treatments delivered by the oral appliance and neurostimulator subsystem via a bidirectional wired or wireless telemetry link. In one embodiment, the closed-loop system comprises: sensing and / or measuring and / or monitoring physiological parameters and / or surrogates of sleep and / or sleep apnea and / or breathing; processing data from these parameters and / or surrogates; or directly controlling neurostimulation and transmitting signals to electrodes to stimulate target anatomical structures. In this embodiment, the processing of these parameters can be performed by a processor located in the oral appliance subsystem or by a processor located in the charging box and remote subsystem. In this embodiment, data can be transmitted to / from the oral appliance subsystem, charging box, and remote subsystem via a bidirectional wired or wireless telemetry link. This data can be stored in the oral appliance subsystem and / or the charging box and remote subsystem and can be accessed by patients and / or physicians and / or surgeons and / or dentists and / or nurses and / or healthcare practitioners and / or any combination thereof to track and / or view and / or titrate and / or modulate and / or optimize neurostimulation parameters and / or usage data and / or compliance data and / or physiological parameters and / or sleep and / or sleep apnea and / or breathing alternatives. In another embodiment, the open-loop system comprises neural stimulation parameters configured based on: polysomnography data; and / or data from home sleep studies; and / or data from another form of sleep study; and / or data from anatomical assessments (such as radiological examinations and / or endoscopic examinations and / or pharmacologically induced endoscopy and / or awake endoscopy and / or laboratory examinations and / or physiological examinations and / or any technical examination and / or any of the foregoing examinations); and / or any combination thereof. In this embodiment, data can be transmitted to / from the oral appliance subsystem, as well as the charging box and remote subsystem, via a bidirectional wired or wireless telemetry link. This data can be stored in the oral appliance subsystem and / or charging box and remote subsystem, and can be accessed by patients and / or physicians and / or surgeons and / or dentists and / or nurses and / or healthcare practitioners and / or any combination thereof to track and / or view and / or titrate and / or regulate and / or modulate and / or optimize neurostimulation parameters and / or use data and / or compliance data and / or physiological parameters and / or sleep and / or sleep apnea and / or breathing alternatives.In this embodiment, the neurostimulation parameters can be titrated and / or modulated and / or adjusted and / or optimized by the patient and / or physician and / or surgeon and / or dentist and / or nurse and / or healthcare practitioner and / or any combination thereof to deliver customized neurostimulation therapy to each patient via a bidirectional wired or wireless telemetry link.

[0097] The device according to some embodiments may include at least a housing configured on the body of a subject near the lesser palatine nerve or upper airway muscles. A main power source may be rechargeable and associated with and / or configured within the housing. The device may additionally include at least one processor associated with the housing and configured to communicate electrically or otherwise with the power source. The at least one processor may be further configured to regulate the delivered power by adjusting at least one of current amplitude, voltage amplitude, frequency, pulse width, duty cycle, pulse configuration, and / or any combination thereof.

[0098] In one embodiment, neural modulation can be delivered using varying modulation parameters based on the characteristics of the patient's sleep-disordered breathing. In one embodiment, the neural modulation signal can be an electrical, magnetic, ultrasonic, piezoelectric, radiation, electromagnetic, radio frequency, mechanical, chemical, optical, or acoustic signal, or any other signal, and / or any combination thereof. In one embodiment, the delivered signal can be delivered continuously and / or in successive bursts of pulses. Such continuous signals and pulse bursts can be in the form of square waves, sine waves, triangular waves, exponential waves, sawtooth waves, pulse waves, arbitrary waveforms, and / or any combination thereof. Such pulse bursts can be monophase or biphase, symmetrical or asymmetrical, and / or any combination thereof. Pulse bursts can be delivered in repeating bursts ranging from 1 pulse per burst to 1,000,000 pulses per burst. Pulse bursts can be delivered at intervals of 0.01 microseconds, ranging from 0.01 microseconds to 600 seconds. Each burst can be delivered with multiple parameters, including current amplitude, voltage amplitude, frequency, pulse width, duty cycle, pulse configuration, and / or any combination thereof. Such current amplitudes can be delivered in the range of 0.01mA to 1A; these parameters are merely exemplary and can be adjusted above or below the given range to achieve suitable results. Such voltage amplitudes can be delivered in the range of 0.01V to 250V; these parameters are merely exemplary and can be adjusted above or below the given range to achieve suitable results. Such frequencies can be delivered in the range of 0.01Hz to 10kHz; these parameters are merely exemplary and can be adjusted above or below the given range to achieve suitable results. Such pulse widths can be delivered in the range of 0.01μs to 600s; these parameters are merely exemplary and can be adjusted above or below the given range to achieve suitable results. Such duty cycles can be delivered in the range of 0% to 100%; these parameters are merely exemplary and can be adjusted above or below the given range to achieve suitable results. Such pulse configurations can be delivered in any configuration to achieve suitable results, including voltage amplitude ramping, current amplitude ramping, voltage amplitude stepping, current amplitude stepping, variable pulse width, variable duty cycle, variable current amplitude, variable voltage amplitude, sine wave configuration, square wave configuration, triangular wave configuration, exponential wave configuration, sawtooth wave configuration, pulse wave configuration, arbitrary wave configuration, in time mode, in time series, in random mode, in random sequence, and / or any combination thereof. Such amplitude ramps can be configured in 0.01 microsecond intervals within the range of 0.0 to 600 seconds; these parameters are merely exemplary and can be adjusted above or below a given range to achieve suitable results. In one embodiment, neural modulation can be delivered with varying modulation parameters within or above the aforementioned range, depending on the disease being treated or monitored.Such pulse trains can be initiated during, before, during, or after inspiration to improve sleep-disordered breathing in patients. The frequency of such delivery can be tailored to neural characteristics or type, anatomical structure, and the desired therapeutic effect, including preferentially or selectively modulating motor fibers, sensory fibers, parasympathetic fibers, sympathetic fibers, or any nerve fiber and / or any combination thereof, to treat conditions affected by the modulation of these fibers. The pulse width can be tailored to neural characteristics or type, anatomical structure, and the desired therapeutic effect, including preferentially or selectively modulating motor fibers, sensory fibers, parasympathetic fibers, sympathetic fibers, or any nerve fiber and / or any combination thereof, to treat conditions affected by the modulation of these fibers. The current amplitude can be tailored to neural characteristics or type, anatomical structure, and the desired therapeutic effect, including preferentially or selectively modulating motor fibers, sensory fibers, parasympathetic fibers, sympathetic fibers, or any nerve fiber and / or any combination thereof, to treat conditions affected by the modulation of these fibers. Such voltage amplitudes can be delivered according to nerve characteristics or type or anatomy and the desired therapeutic effect, including preferentially or selectively modulating motor fibers or sensory fibers or parasympathetic fibers or sympathetic fibers or any nerve fiber and / or any combination thereof, to treat conditions affected by the modulation of these fibers. Such duty cycles can be delivered according to nerve characteristics or type or anatomy and the desired therapeutic effect, including preferentially or selectively modulating motor fibers or sensory fibers or parasympathetic fibers or sympathetic fibers or any nerve fiber and / or any combination thereof, to treat conditions affected by the modulation of these fibers. Such pulse configurations can be delivered according to nerve characteristics or type or anatomy and the desired therapeutic effect, including preferentially or selectively modulating motor fibers or sensory fibers or parasympathetic fibers or sympathetic fibers or any nerve fiber and / or any combination thereof, to treat conditions affected by the modulation of these fibers. Such pulse trains, frequencies, pulse widths, current amplitudes, voltage amplitudes, duty cycles, pulse configurations, and any other modulation parameters can be delivered non-selectively and / or in any combination to treat conditions affected by the modulation of these fibers. These parameters are merely illustrative and can be adjusted to be higher or lower than the given range to achieve the desired results.

[0099] Not wishing to be bound by a particular embodiment, methods and systems for treating sleep-disordered breathing can be designed, made, constructed, constructed, formed, assembled, molded, fabricated, or produced such that electrodes are placed according to the specific patient's anatomy to achieve optimal airway opening and improvement of the patient's sleep-disordered breathing. For example, where anterior and posterior palatal collapse is identified as the primary mechanism of airway collapse, electrodes can be placed in a delivery system to preferentially, globally, or in combination with other anatomical mechanisms and / or neuromodulation to activate the palatoglossus and levator palpebrae veli muscles to generate forward movement of the palate, thereby relieving anterior and posterior palatal obstruction and generating airway opening. Electrodes can be positioned to contact the mucosa covering the desired neuromodulation target to modulate the underlying nerves and muscles to generate the desired nerve and / or muscle activation, thereby generating airway opening and improving the patient's sleep-disordered breathing. One or more electrodes transmitting neuromodulation signals can be placed 0 mm to 30 cm apart to achieve activation of the target nerve and / or muscle, and / or partial or complete or tonic or sub-tonic activation of the desired nerve and / or muscle target. In one embodiment, the electrode may be placed at the end of a muscle length to generate activation along the entire length of that muscle, thereby maximizing airway opening and improving sleep-disordered breathing in the patient. For example, the electrode may be placed in any delivery system on the teeth and / or hard palate, and / or soft palate, and / or maxillary surface of the oral cavity, wherein the receiving electrode is in a delivery system, alone or in combination, in the retromolar triangle and / or mandibular teeth, and / or floor of the mouth, and / or bone, and / or mandible, and / or submandibular region, and / or internal neck, and / or lateral surface of the neck, and / or palatoglossus and / or palatopharyngeal and / or superior and / or middle retractor muscles and / or intralingual muscles (such as superior longitudinal muscles, or inferior longitudinal muscles, or transverse or vertical muscles). And / or the lateral tongue muscles (such as the genioglossus, hyoidoglossus, or styloglossus, and / or any combination thereof), and / or the band-like muscles (such as the sternothyroidus, and / or thyrohyoidoglossus, and / or omohyoidoglossus, and / or sternohyoidoglossus, and / or any combination thereof) and / or the lower insertion point and / or intermediate material and / or any component of the masseter muscle, such that neural regulatory signals are transmitted to and / or through the nerve and / or muscle and produce activation of that muscle, thereby generating airway opening and improving the patient's sleep-disordered breathing. For example and reference Figure 18 The electrode can be placed at the supramedial insertion point from the palatoglossus muscle to the palatine aponeurosis in the retainer, and the receiving electrode is placed on the retromolar triangle, so that neural modulation signals can be transmitted along the length of the palatoglossus muscle. In another embodiment and referenced Figure 18The electrode can be placed at the supramedial insertion point from the palatoglossus muscle to the palatine aponeurosis within the retainer, and the receiving electrode is placed on a device component positioned above the third molar, allowing neural modulation signals to be transmitted along the length of the palatoglossus muscle to a fixed point fastened to the mandibular tooth. In this embodiment, a non-conductive coating or material can contact the tooth and the receiving electrode embedded in the non-conductive coating or material to prevent modulation of the dental pulp nerve, inferior alveolar nerve, or any nerve not intended to be modulated. In another embodiment and referenced... Figure 18 The electrode can be placed at the supramedial insertion point of the palatoglossus muscle to the palatine aponeurosis in the retainer, and the receiving electrode is placed at the lingual insertion point of the palatoglossus muscle, so that neural modulation signals can be transmitted along the length of the palatoglossus muscle. In another embodiment and referenced Figure 19 The electrodes can be placed in the retainer in any arrangement, array, distribution, or position relative to the muscles intended to be activated, and the receiving electrodes can be placed in any arrangement, array, distribution, or position relative to the muscles intended to be activated, such that neuromodulation signals can be transmitted along the length of those muscles to activate them. For example, the electrodes can be positioned laterally on the uvula to transmit neuromodulation signals across the muscle to activate it and produce an airway opening effect. These electrodes can be placed in any orientation capable of capturing the nerves and / or muscles of interest, such as vertically or horizontally. In another embodiment and referenced Figure 19 The electrode assembly can be placed submucosally near nerve and / or muscle targets in any arrangement, array, distribution, or location relative to the muscles intended to be activated, and the receiving electrodes can be placed in any arrangement, array, distribution, or location relative to the muscles intended to be activated, such that neuromodulation signals can be transmitted along the length of these muscles to selectively or in combination activate these muscles as needed to produce airway opening and improve the patient's sleep-disordered breathing. In one embodiment and referenced Figure 20 The electrode array can be placed in a retainer close to nerve and / or muscle targets to achieve a wide or narrow field, allowing selective or combined activation of one or more muscles within that field as needed to create airway opening and improve sleep-disordered breathing in patients. In another embodiment and referenced Figure 20 Electrode arrays can be placed submucosally and / or subcutaneously and / or intramuscularly and / or perimuscularly and / or near any nerve and / or muscle target to achieve a wide or narrow field, allowing selective or combined activation of one or more muscles within that field as needed to produce airway opening and improve sleep-disordered breathing in patients. For example, and refer to... Figure 21One or more electrodes and / or electrode arrays may be placed submucosally and / or subcutaneously and / or intramuscularly and / or perimuscularly and / or near the ultramedial insertion points of the palatopharyngeal and / or palatoglossal muscles, as well as at the lower insertion points of these muscles, to activate nerves and / or muscles, generate airway opening, and improve sleep-disordered breathing in patients. In all embodiments herein, neural modulation signals may be transmitted in one or more directions to activate nerves and / or muscles, generate airway opening, and improve sleep-disordered breathing in patients. In all embodiments herein, one or more electrodes and / or electrode arrays may be placed in any anatomical location and / or multiple locations to provide maximal modulation of the target nerve and / or nerve and / or muscle and / or multiple muscles in the form of a therapeutic delivery system and / or device and / or appliance and / or retainer and / or non-invasive method and / or procedure and / or invasive method and / or procedure and / or implant and / or non-implant form to generate airway opening and improve sleep-disordered breathing in patients. The foregoing is merely a few examples of therapeutic delivery systems for sleep-disordered breathing; however, the embodiments of the invention described below are not necessarily limited to the above embodiments.

[0100] In one embodiment, a physician and / or surgeon and / or dentist and / or nurse and / or healthcare practitioner and / or any combination thereof may select electrode placement to target nerves and / or multiple nerves and / or muscles and / or multiple muscles based on the patient's anatomy and / or physiological characteristics in order to treat the patient's sleep-disordered breathing and / or optimize and / or titrate therapy and / or its effects. The physician and / or surgeon and / or dentist and / or nurse and / or healthcare practitioner and / or any combination thereof may utilize anatomical data from a clinical examination for this purpose, including oral and / or nasal cavity and / or nasopharynx and / or oropharynx and / or hypopharynx and / or tongue and / or tongue root and / or larynx and / or supraglottic and / or glottic and / or subglottic oral examination, and / or nasal examination, and / or nasopharyngeal examination, and / or oropharyngeal examination, and / or hypopharyngeal examination and / or larynx examination and / or tongue examination, and / or tongue root examination, and / or supraglottic examination. Examinations, and / or glottic examinations, and / or subglottic examinations, and / or endoscopic and / or non-endoscopic examinations, neck examinations, craniofacial examinations, facial bone examinations, airway examinations, dental examinations, and / or radiological examinations, and / or endoscopic examinations, and / or drug-induced endoscopy, and / or awake endoscopy, and / or laboratory examinations, and / or physiological examinations, and / or any technical examination, and / or any of the foregoing examinations, and / or any other method for screening and / or diagnosing sleep-disordered breathing, and / or any method, and / or any combination thereof. For this purpose, physicians and / or surgeons and / or dentists and / or nurses and / or healthcare practitioners and / or any combination thereof may utilize physiological data from clinical examinations and / or polysomnography and / or any of the foregoing examination types and / or any combination thereof. The foregoing is merely a few examples of therapeutic delivery systems for sleep-disordered breathing; however, the embodiments of the invention described below are not necessarily limited to the above embodiments.

[0101] In one embodiment, sensing modalities embedded in a device designed to improve a patient's sleep-disordered breathing can be used to acquire data to inform healthcare providers (including physicians and / or surgeons and / or dentists and / or nurses and / or healthcare practitioners and / or any combination thereof) on efficacy, and / or effectiveness, and / or adherence, and / or compliance, and / or disease improvement, and / or symptom improvement, and / or quality of life improvement, and / or daytime functioning improvement, and / or sleep quality improvement, and / or any of the foregoing health, and / or wellness indicators, and / or any combination thereof. In one embodiment, healthcare providers (including physicians and / or surgeons and / or dentists and / or nurses and / or healthcare practitioners and / or any combination thereof) can use this data to optimize and / or titrate and / or monitor treatment and / or any combination thereof. Data obtained from these examinations and / or modalities include data relating to: airway volume, and / or airway obstruction, and / or airway patency, and / or critical closure pressure of the pharynx and / or palate, and / or increased opening pressure of the pharynx and / or palate, and / or airway tissue collapse, and / or airway muscle collapse, and / or pharyngeal airflow, and / or pulmonary ventilation, and / or the presence and / or frequency of apnea, and / or the frequency and / or presence of hypoxia, and / or the apnea-hypopnea index, and / or the oxygen saturation drop index, and / or minimum oxygen saturation, and / or hypoxic duration, and / or relative hypoxic duration, and / or hypercapnia and / or hypercapnia, and / or sleep quality, and / or sleep efficiency, and / or sleep quality, and / or daytime sleepiness, and / or snoring, and / or awakening frequency, and / or total sleep time, and / or sleep onset. Post-awakening, and / or sleep stage, and / or REM sleep, and / or non-REM sleep, and / or REM latency, and / or frequency of central apnea, and / or presence and / or frequency of mixed apnea, and / or number of respiratory events, and / or supine breathing events, and / or lateral breathing events, and / or prone breathing events, and / or any sleep quality indicator, and / or any sleep disorder, and / or any sleep disturbance, and / or cardiovascular risk, and / or cerebrovascular risk, and / or metabolic risk, and / or sleep latency, and / or respiratory effort-related arousal, and / or circadian rhythm function, and / or any polysomnography parameter, and / or any non-polysomnography parameter, and / or any sleep quality indicator, and / or nasal function, and / or sinus function, and / or any health benefit, and / or any combination thereof.Data obtained from the device may include oxygen saturation, respiratory rate and / or rhythm and / or regularity and / or irregularity and / or pattern and / or variability, airflow data (including nasal and / or nasopharyngeal and / or oropharyngeal and / or oral cavity and / or hypopharynx and / or larynx and / or glottis and / or supraglottic and / or subglottic and / or external airflow), pressure data (including nasal and / or nasopharyngeal and / or oropharyngeal and / or oral cavity and / or hypopharynx and / or larynx and / or glottis and / or supraglottic and / or subglottic pressure), and sound (including presence and / or absence and / or amplitude and / or volume and / or pitch and / or frequency and / or sound quality and / or snoring and / or snores). (or wheezing and / or any airway noise timbre), longitudinal compression wave data (including snoring and / or snores and / or wheezing and / or any airway noise), positional data (including spatial motion and / or acceleration and / or orientation), heart rate and / or rhythm and / or regularity and / or irregularity and / or pattern and / or variability, blood pressure (including systolic and / or diastolic blood pressure and / or mean venous blood pressure and / or mean arterial blood pressure), salivation production and / or function and / or physical components (including enzymes and / or proteins and / or peptides and / or electrolytes and / or ions and / or antibodies and / or peptides and / or hormones and / or metabolites and / or microorganisms and / or toxins and The presence and / or function of / or drugs and / or genetic material and / or lipids and / or pH, and / or chemical components (including enzymes and / or proteins and / or peptides and / or electrolytes and / or ions and / or antibodies and / or peptides and / or hormones and / or metabolites and / or microorganisms and / or toxins and / or drugs and / or genetic material and / or lipids and / or pH), and / or salivary flow, and / or salivary pH, autonomic nervous system activity (including sympathetic and / or parasympathetic activity), vasoconstriction, vasodilation, mucosal color and / or volume and / or elasticity and / or tensile strength and / or compressibility and / or viscoelasticity and / or stiffness. And / or softness and / or thickness and / or heat capacity and / or thermal conductivity and / or optical properties and / or transparency and / or light scattering and / or light absorption and / or cell integrity and / or cell content and / or permeability and / or absorption and / or gene expression and / or protein expression and / or motility and / or oxygen consumption and / or nutrient utilization and / or receptor expression, vascularization, neural activity and / or function, muscle activity and / or function, electromyography, electrocardiography, electrooculography, electroencephalography, endothelial activity and / or function, epithelial activity and / or function, plethysmography, temperature, heat capacity and / or any parameter related to the foregoing parameters, and / or any combination thereof. The foregoing is merely a few examples of therapeutic delivery systems and methods for monitoring and / or improving the treatment of sleep-disordered breathing in patients; however, the embodiments of the invention described below are not necessarily limited to the above embodiments.

[0102] Integrating sensors into neurostimulation oral appliances for the treatment of obstructive sleep apnea (OSA) offers the potential for significant advancements in the diagnosis, treatment, and monitoring of this condition. By embedding sensors within the appliance, real-time data on a variety of physiological parameters can be collected, enabling personalized treatment, improved efficacy, and enhanced patient compliance. Various sensors, one or more, can be incorporated into different components of the neurostimulation oral appliance, including but not limited to electrophysiological sensors, respiratory sensors, position and motion sensors, timing sensors, saliva sensors, and / or biometric sensors. Examples of electrophysiological sensors include, but are not limited to: electromyography (EMG) sensors for measuring muscle activity of the tongue, and / or palate, and / or pharynx, and / or airway, and / or jaw, and / or respiratory muscles; electroencephalography (EEG) sensors for monitoring brain activity, particularly sleep stages and arousal; electrooculography (EOG) sensors for tracking eye movements and indicating sleep stages and rapid eye movement (REM) sleep; and ohmmeters for tracking tissue impedance and indicating tissue moisture, electrode contact quality, and resistance to stimulation. Examples of respiratory sensors include, but are not limited to: thermistor-based airflow sensors for measuring temperature changes caused by airflow; and / or piezoelectric current sensors for directly measuring airflow and converting it into an electrical signal; and / or metering piezoresistive pressure sensors for measuring air pressure or differential pressure in the airway; and / or capacitive pressure sensors for measuring air pressure or differential pressure in the airway; and / or hot-wire anemometers for measuring airflow velocity by heating wires and measuring the cooling effect of the airflow; and / or microphones for measuring and recording snoring and / or wheezing and / or airway noise to measure the sound response during breathing; and / or chest and abdominal impedance sensors for measuring changes in impedance across the chest and abdomen during breathing, etc. These respiratory sensors can be used to determine physiological parameters, including but not limited to the volume and velocity of air moving through the upper airway, respiratory rate, tidal volume, respiratory rhythm, and apnea / hypoventricular events, etc. Examples of position and motion sensors include, but are not limited to: accelerometers for measuring acceleration on three axes and monitoring jaw movement, head position, and appliance movement; gyroscopes for measuring angular velocity and orientation to detect changes in head movement and sleep position; magnetometers for measuring magnetic field strength and determining the orientation of appliances and heads relative to the magnetic field; and strain gauges for measuring strain or deformation in appliances and monitoring jaw movement and appliance deflection, etc.Examples of timing sensors include, but are not limited to: real-time clocks for providing accurate timing to measure sleep onset and duration and align other sensor data with sleep stages; event counters for counting the occurrence of specific events, including but not limited to apnea, hypopnea, bruxism, awakening, device displacement, and device removal; interval timers for measuring the time interval between events to calculate the delay between entering a prone position and sleep onset, the delay between stimulus and muscle and / or airflow response, the length of sleep cycle stages, and the duration of apnea, hypopnea, and / or bruxism events; and timestamping circuitry for assigning precise timestamps to data points to enable data correlation from different sensors. Examples of saliva sensors include pH sensors, electrolyte sensors, and biomarker sensors to detect changes in salivary chemistry in response to apnea and / or neural modulation. Examples of respiratory sensors include oxygen sensors, carbon dioxide sensors, and / or other volatile content sensors to detect changes in respiratory composition as a response to apnea events and / or neural modulation. Examples of biometric sensors include heart rate sensors for measuring heart rate and heart rate variability to assess cardiovascular responses to sleep apnea, evaluate overall sleep quality, detect arrhythmias, and / or assess cardiovascular responses to neural stimulation; pulse oximeters (blood oxygen sensors), including infrared light-emitting diodes and photoplethysmography sensors, for measuring blood oxygen saturation levels to assess the severity of oxygen saturation during apnea and / or hypopnea events, detect and measure the frequency of apnea and / or hypopnea events, and assess the effectiveness of neural stimulation in improving oxygen saturation; blood pressure sensors for measuring blood pressure, including systolic and / or diastolic blood pressure and / or mean arterial pressure or venous pressure and / or pressure waveforms, to assess physiological responses to apnea and / or neural modulation; temperature sensors, including thermistors, resistance temperature detectors, thermocouples, semiconductor-based (IC) temperature sensors, and / or infrared thermometers, to measure patient body temperature and monitor core temperature changes associated with sleep stages and apnea responses; and skin conductance sensors for measuring changes in skin conductance to assess pressure levels and awakening patterns during sleep. The sensor can be positioned as being completely encapsulated within an oral appliance; or positioned based on the location of specific anatomical structures within the oral cavity, including but not limited to gingival capillaries, airway muscles, hard palate, soft palate, maxilla, mandible, motor nerves, sympathetic nerves, parasympathetic nerves, sensory nerves, dentition, and / or brain matter; and / or positioned based on the location of specific anatomical structures outside the oral cavity, including but not limited to fingers, palms, wrists, forehead, armpits, rectum, neck, chest, oral cavity, nasal cavity, earlobes, mandible, chin, eyes, scalp, and / or head.Embedded sensors allow for closed-loop feedback and control of stimulation parameters, including stimulation onset delay, stimulation triggering, stimulation current amplitude, stimulation voltage amplitude, stimulation frequency, stimulation duty cycle, stimulation pulse width, and / or waveform shape. Furthermore, real-time data can be used to signal a pulse generator to initiate neuromodulation delivery as needed by the patient after falling asleep or during a specific sleep stage. This can be programmed by any healthcare practitioner or technician, or the person initiating and programming the treatment, to optimize therapeutic efficacy and prevent awakenings induced by neuromodulation therapy before or during sleep. The foregoing are merely a few examples of therapeutic delivery systems and methods for monitoring and / or improving the treatment of sleep-disordered breathing in patients; however, the embodiments of the invention described below are not necessarily limited to the above embodiments.

[0103] In one embodiment, focused neural modulation signals can be differentially delivered to different submucosal depths to modulate one and / or multiple nerves and / or one and / or multiple muscles at different distances from the mucosal surface. This allows for precise control of the spatial and temporal parameters of neural modulation, enabling more targeted and effective therapeutic interventions. Different penetration depths can be achieved by adjusting pulse width, and / or current amplitude, and / or current density, and / or voltage amplitude, and / or frequency, and / or duty cycle, and / or constructive interference with intersecting waveforms and / or destructive interference with intersecting waveforms and / or physical amplification of waveforms and / or physical impedance of waveforms and / or any combination thereof. Neural modulation at different depths can also be achieved through electrode design, and / or shape, and / or size, and / or location, and / or material, and / or differential impedance, and / or contact quality with tissue, and / or array density, and / or fabrication method, and / or polarity, and / or any other component of electrode design and / or any combination thereof. For example, neural modulation at varying depths and widths can be achieved using microneedle arrays, microelectrode arrays, concentric coil electrodes, concentric ring electrodes, multilayer electrodes, flexible electrodes, penetrating electrodes, electrode arrays, monopolar electrodes, bipolar electrodes, multipolar electrodes, and / or any combination of these electrode designs. Novel electrode materials and configurations allow for precise control of the spatial and temporal parameters of neural stimulation. By carefully selecting electrode materials with different electrical properties and manipulating surface characteristics, varying degrees of tissue penetration and current diffusion can be achieved, thereby enabling the modulation of neural activity at specific depths and within defined regions of the nervous system. The surface properties of electrodes play a crucial role in defining the interface with neural tissue. For example, hydrophilic electrode surfaces can enhance tissue integration, biocompatibility, and reduce inflammation, potentially improving stimulation efficacy and reducing adverse reactions. Conversely, hydrophobic surfaces can minimize tissue adhesion and facilitate electrode removal. The roughness of the electrode surface can also influence nerve cell behavior. Textured surfaces can promote cell attachment and growth, while smooth surfaces can reduce tissue damage. Furthermore, the presence of specific biofunctional molecules on the electrode surface can be used to target specific cell types or induce desired biological responses. The choice of electrode material is critical for achieving the desired neuromodulation effects.For example, conventional metallic materials, and / or metal alloys, and / or metal oxides, and / or conductive polymers, and / or carbon-based conductive materials, and / or conductive ceramics, and / or conductive hydrogels, and / or conductive silicon materials, and / or any combination thereof (including combinations of materials within a single category) can be used as electrode materials. Examples of conventional metallic materials that can be used include, but are not limited to, any one of platinum, gold, titanium, silver, copper, nickel, zinc, and tungsten, as well as palladium. Examples of metal alloys that can be used include, but are not limited to, any one of stainless steel, nickel-chromium, platinum-iridium, and silver-silver chloride. Examples of metal oxides include, but are not limited to, any one of tin oxide, indium tin oxide, ruthenium oxide, and titanium oxide. Examples of conductive polymers that can be used include, but are not limited to, any one of polyaniline, polypyrrole, PEDOT (poly(3,4-ethylenedioxythiophene)), and polythiophene. Examples of carbon-based conductive materials include, but are not limited to, any one of carbon fibers, graphene, diamond-like carbon, graphite, carbon nanotubes, and carbon black. Examples of conductive ceramics include, but are not limited to, any one of lanthanum strontium manganeseite, lead oxide, ruthenium dioxide, bismuth ruthenate, bismuth iridiumate, indium tin oxide, lanthanum-doped strontium titanate, and ferrites. Examples of conductive hydrogels include, but are not limited to, any one of polypyrrole hydrogels, polyaniline hydrogels, PEDOT:PSS (poly(3,4-ethylenedioxythiophene:polystyrene sulfonate) hydrogels, carbon nanotube hydrogels, graphene hydrogels, silver nanoparticle hydrogels, gold nanoparticle hydrogels, ionic hydrogels, and hybrid hydrogels. Examples of conductive silicone materials that can be used include, but are not limited to, N-type silicon, P-type silicon, silicon carbide, silicon nitride, and silicon-based conductive polymers.

[0104] Not wishing to be bound by a particular embodiment, methods and systems for treating sleep-disordered breathing can be designed, manufactured, constructed, constructed, formed, assembled, molded, fabricated, or produced such that electrodes are placed according to the specific patient's anatomy to achieve optimal improvement in airway patency and sleep-disordered breathing. Methods for placing these electrodes within a final device assembly can include direct embedding, surface mounting, masked thermoforming, flexible circuitry, 3D printing, electrodeposition, laser-induced forward transfer, inkjet printing, and electrode encapsulation. Direct embedding involves incorporating electrodes directly into the appliance material during the manufacturing process to achieve simplified design and precise electrode placement. Surface mounting involves attaching electrodes to the surface of a prefabricated appliance using adhesives, clips, or other mechanical fasteners to allow for flexibility in electrode placement. Masked thermoforming involves thermoforming the mechanical parts of the appliance around a dental mold while masking the electrodes, thereby exposing them while keeping the rest of the circuitry fully embedded and sealed. Flexible circuitry involves containing embedded electrodes throughout a flexible circuitry integrated into the appliance to enable complex electrode configurations and potential integration of additional components such as sensors or wireless communication components. 3D printing technology involves using additive manufacturing to allow the creation of complex structures and embedding electrodes directly within the printed material, enabling exceptional design freedom and customization. Electrodeposition involves using electrochemical processes to deposit electrodes directly onto appliance surfaces or preforms, providing precise control over electrode geometry and material composition. Laser-induced forward transfer involves using laser energy to transfer electrode material onto appliance surfaces, allowing the deposition of various materials and the formation of precise patterns. Inkjet printing involves depositing conductive ink containing electrode material into appliance surfaces in desired patterns, enabling flexibility in electrode design integration with other manufacturing processes. Hybrid embedding techniques utilizing one or more of the aforementioned technologies exist. For example, a combination of direct embedding and surface mounting might involve embedding a base electrode structure within appliance material and then attaching additional electrodes or components to the surface to provide a balance between integration and flexibility. Another example could include combining flexible circuitry with 3D-printed structures to create complex and customized electrode configurations. Flexible circuitry can be integrated into the 3D-printed substrate to improve conductivity and reliability. Additionally, electrodes may need to be protected from the oral environment, which can be provided through methods such as material selection, encapsulation, and / or coating.

[0105] Not wishing to be bound by a particular embodiment, methods and systems for treating sleep-disordered breathing can be designed, manufactured, built, constructed, formed, assembled, molded, fabricated, or produced such that sensors are placed according to the specific patient's anatomy to measure a variety of physiological, environmental, and / or bioassay data, etc. Methods for placing these sensors within the final device assembly can include direct embedding, surface mounting, masked thermoforming, flexible circuitry, 3D printing, and / or sensor encapsulation, etc. Direct embedding involves incorporating sensors directly into the appliance material during the manufacturing process to achieve a simplified design and precise sensor layout. Surface mounting involves attaching sensors to the surface of a prefabricated appliance using adhesives, clips, or other mechanical fasteners to allow for flexibility in sensor layout. Masked thermoforming involves thermoforming the mechanical parts of the appliance around a dental mold while masking the sensors, thereby exposing them while keeping the rest of the circuitry fully embedded and sealed. Flexible circuitry involves containing embedded sensors within a flexible circuitry integrated into the appliance to enable complex sensor configurations and potential integration of additional components such as sensors or wireless communication components. 3D printing technology involves utilizing additive manufacturing to allow the creation of complex structures and the direct embedding of sensors within the printed material, enabling exceptional design freedom and customization. Hybrid embedding techniques utilizing one or more of the aforementioned technologies exist. For example, a combination of direct embedding and surface mounting might involve embedding a basic sensor structure within the instrument material and then attaching additional sensors or components to the surface to provide a balance between integration and flexibility. Another example could include combining flexible circuitry with 3D-printed structures to create complex and customized sensor configurations. Flexible circuitry can be integrated into the 3D-printed base to improve conductivity and reliability. Additionally, sensors may need to be protected from the oral environment, which can be provided through methods such as material selection, encapsulation, and / or coating.

[0106] Not wishing to be bound by a particular embodiment, methods and systems for treating sleep-disordered breathing can be designed, manufactured, built, constructed, formed, assembled, molded, fabricated, or produced such that circuit components, including but not limited to microcontrollers, power management ICs, wireless communication modules, sensor interface circuits, stimulator driver circuits, and / or batteries, are placed and encapsulated within the system to enable the system to conform to the patient's anatomy. Methods for placing this circuitry within the final device assembly can include direct embedding, surface mounting, masked thermoforming, flexible circuitry, 3D printing, thin-film electronics, and / or circuit encapsulation. Direct embedding involves incorporating the circuitry directly into the appliance material during the manufacturing process to achieve a simplified design and precise sensor placement. This can include thermoforming the circuitry to seal it within the appliance or initial attachment prior to sealing the circuit components. Surface mounting involves attaching the sensor to the surface of a prefabricated appliance using adhesives, clips, or other mechanical fasteners to allow for flexibility in circuit layout. Circuit components may be mounted prior to sealing, coating, or other forms of encapsulation. Masked thermoforming involves thermoforming the mechanical parts of an appliance around a dental model while simultaneously masking the circuitry, thus protecting them from the effects of thermoforming temperatures and materials during the assembly process. Flexible circuitry involves utilizing flexible printed circuit boards that can be integrated into the appliance structure, allowing for complex circuit layouts and adaptability to the oral environment to enable the potential integration of complex sensor configurations and additional components such as sensors or wireless communication components. 3D printing technology involves utilizing additive manufacturing to allow the creation of complex structures and the direct embedding of circuitry within the printed material, enabling exceptional design freedom and customization. Thin-film electronics involves depositing electronic components directly onto the appliance material, providing miniaturization and integration benefits. Hybrid embedding techniques utilizing one or more of the aforementioned technologies exist. For example, a combination of direct embedding and surface mounting might involve embedding a basic circuit structure within the appliance material and then attaching additional circuitry components to the surface to provide a balance between integration and flexibility. Another example could include combining flexible circuitry with a 3D-printed structure to create complex and customized circuit configurations. Flexible circuitry can be integrated into a 3D-printed substrate to improve conductivity and reliability. In addition, the circuitry may need to be protected from the oral environment, which can be provided through methods such as material selection, encapsulation, and / or coating.

[0107] In one embodiment, energy can be delivered from the delivery system with different parameters depending on the desired disease state. In one embodiment, the energy signal can be an electrical or magnetic or ultrasonic or piezoelectric or radiative or electromagnetic or radio frequency or mechanical or chemical or optical or light or heat or sound signal, or any other signal, and / or any combination thereof. In one embodiment, the delivered signal can be delivered continuously and / or in single and / or successive pulse trains. Such continuous signals and pulse trains can be in the form of square waves, sine waves, triangular waves, exponential waves, sawtooth waves, pulse waves, arbitrary waveforms, and / or any combination thereof. In one embodiment, the delivered energy can be delivered to achieve electroporation and / or photodynamic therapy to assist in intracellular and / or intratumoral and / or extratumoral, and / or peritumoral, and / or local, and / or systemic treatment of diseases such as tumors and / or any combination thereof. In one embodiment, energy can be delivered from 0 V / cm to 1000 kV / cm to induce electroporation in benign tumors, and / or malignant tumors, and / or precancerous tumors or lesions, and / or cancer, and / or carcinoma, and / or sarcoma, and / or any lesion, and / or any tissue, and / or any combination thereof. These parameters are merely exemplary and can be adjusted above or below the given ranges to achieve suitable results. In one embodiment, electroporation can be designed to increase the distribution, and / or dispersion, and / or intracellular, and / or intratumoral, and / or extratumoral, and / or peritumoral, and / or local, and / or systemic concentration of molecules, and / or drugs, and / or nanoparticles, and / or biologics, and / or genes, and / or ions, and / or any antitumor therapy in the tumor, and / or any combination thereof. In one embodiment, the delivered electroporation signal can be delivered continuously and / or in successive pulse trains. Such continuous signals and pulse trains can take the form of square waves, sine waves, triangle waves, exponential waves, sawtooth waves, pulse waves, arbitrary waveforms, and / or any combination thereof. Such pulse trains can be single-phase or two-phase, symmetrical or asymmetrical, and / or any combination thereof. Pulse trains can be delivered in repeating bursts ranging from 1 pulse per train to 1,000,000 pulses per train. Pulse trains can be delivered at intervals of 0.01 microseconds, ranging from 0.01 microseconds to 600 seconds. Each burst can be delivered with multiple parameters, including current amplitude, voltage amplitude, frequency, pulse width, duty cycle, pulse configuration, and / or any combination thereof. Such current amplitudes can be delivered in the range of 0.01 mA to 1 A; these parameters are merely exemplary and can be adjusted above or below the given range to achieve suitable results. Such frequencies can be delivered in the range of 0.01 Hz to 10,000 GHz; these parameters are merely exemplary and can be adjusted above or below the given range to achieve suitable results.Such pulse widths can be delivered in the range of 0.01 μs to 600 s; these parameters are merely exemplary and can be adjusted above or below the given range to achieve suitable results. Such duty cycles can be delivered in the range of 0% to 100%; these parameters are merely exemplary and can be adjusted above or below the given range to achieve suitable results. Such pulse configurations can be delivered in any configuration to achieve suitable results, including voltage amplitude ramp, current amplitude ramp, voltage amplitude step, current amplitude step, variable pulse width, variable duty cycle, variable current amplitude, variable voltage amplitude, sine wave configuration, square wave configuration, triangular wave configuration, exponential wave configuration, sawtooth wave configuration, pulse wave configuration, arbitrary wave configuration, in time mode, in time sequence, in random mode, in random sequence, and / or any combination thereof. Such amplitude ramps can be configured in 0.01 microsecond intervals in the range of 0.0 to 600 seconds; these parameters are merely exemplary and can be adjusted above or below the given range to achieve suitable results. In one embodiment, neural modulation can be delivered with varying modulation parameters within or above the aforementioned range, depending on the disease being treated or monitored. In one embodiment, electroporation can be reversible, and / or irreversible, and / or thermally irreversible, and / or any combination thereof. In one embodiment, electroporation can be designed to increase radiosensitivity, and / or chemosensitivity, and / or induce cell death in any tissue and / or tumor intended for treatment via any cell death mechanism. In one embodiment, electroporation can be designed to reduce tumor volume, and / or induce tumor death, and / or enhance radiotherapy, and / or brachytherapy, and / or chemotherapy, and / or surgery, and / or ablation, and / or any therapy intended to treat a tumor, in order to improve the therapeutic effect of any antitumor therapy or treatment modality or treatment method and / or any combination thereof. In one embodiment, electroporation may be intended to be delivered to head and neck tumors in the following areas: respiratory and digestive tracts, and / or oral cavity, and / or oropharynx, and / or tonsils, and / or hypopharynx, and / or larynx, and / or supraglottic, and / or epiglottis, and / or glottis, and / or subglottic, and / or base of tongue, and / or tongue, and / or lips, and / or nasal cavity, and / or nasopharynx, and / or sinuses, and / or skull base, and / or bone, and / or soft tissue, and / or mucosa, and / or muscle, and / or teeth, and / or cartilage, and / or tendons, and / or ligaments, and / or connective tissue, and / or salivary glands, and / or esophagus, and / or lymph nodes, and / or neck, and / or skin, and / or nerves, and / or blood vessels, and / or airways, and / or any anatomical region of the head and neck, and / or any combination thereof.In one embodiment, electroporation may be intended to treat squamous cell carcinoma, and / or human papillomavirus-positive squamous cell carcinoma, and / or human papillomavirus-negative squamous cell carcinoma, and / or p-16-positive squamous cell carcinoma, and / or p-16-negative squamous cell carcinoma, and / or nasopharyngeal carcinoma, and / or pleomorphic adenoma, and / or Worsham's tumor, and / or mucoepidermoid carcinoma, and / or acinar cell carcinoma, and / or adenoid cystic carcinoma, and / or salivary duct carcinoma, and / or thyroid carcinoma. Adenoma, and / or papillary thyroid carcinoma, and / or follicular thyroid carcinoma, and / or medullary thyroid carcinoma, and / or undifferentiated thyroid carcinoma, and / or parathyroid adenoma, and / or parathyroid carcinoma, and / or squamous cell carcinoma of the paranasal sinuses, and / or adenocarcinoma of the paranasal sinuses, and / or undifferentiated carcinoma of the paranasal sinuses, and / or lipoma, and / or hemangioma, and / or sarcoma, and / or rhabdomyosarcoma, and / or fibrosarcoma, and / or angiosarcoma, and / or osteosarcoma, and / or cartilage. Sarcoma, and / or liposarcoma, and / or leiomyosarcoma, and / or synovial sarcoma, and / or angiosarcoma, and / or neuroma, and / or malignant peripheral nerve sheath tumor, and / or epithelioid sarcoma, and / or dermatofibrosarcoma, and / or clear cell sarcoma, and / or alveolar soft tissue sarcoma, and / or desmoidoma, and / or myxofibril sarcoma, and / or undifferentiated pleomorphic sarcoma, and / or gastrointestinal stromal tumor, and / or Kaposi's sarcoma, and / or giant cell tumor of bone And / or adamantocyte tumor, and / or chordoma, and / or Ewing sarcoma, and / or papilloma, and / or osteoma, and / or chondroma, and / or schwannoma, and / or neurofibroma, and / or basal cell carcinoma, and / or nasal tumor, and / or nasal polyp, and / or olfactory neuroblastoma, and / or acoustic neuroma, and / or melanoma, and / or verrucous carcinoma, and / or any tumor, and / or any cancer, and / or any carcinoma, and / or any combination thereof. The foregoing is merely a few examples of therapeutic delivery systems for sleep apnea; however, the embodiments of the invention described below are not necessarily limited to the above embodiments.

[0108] In one embodiment, electroporation energy can be delivered as a combination of the following and / or incorporated thereof: retainer, and / or non-retainer form, and / or stent form, and / or catheter form, and / or cannula form, and / or non-implant form, and / or implant form, and / or surgery (including nasal surgery and / or nasopharyngeal surgery, and / or oral surgery and / or oropharyngeal surgery and / or palatal surgery and / or tonsil surgery and / or pharyngeal lateral wall surgery and / or pharyngeal surgery and / or oropharyngeal surgery and / or hypopharyngeal surgery and / or tongue surgery and / or tongue root surgery and / or supraglottic surgery and / or epiglottic surgery and / or glottic surgery and / or subglottic surgery and / or craniofacial surgery and / or facial bone surgery and / or hyoid bone surgery and / or dental surgery). Orthodontic treatment and / or neck surgery and / or thyroid surgery and / or parathyroid surgery and / or salivary gland surgery and / or lymph node surgery and / or soft tissue surgery and / or skin surgery and / or skull base surgery and / or sinus surgery and / or orbital surgery and / or eye surgery and / or vascular surgery and / or neurosurgery and / or minimally invasive procedures and / or non-invasive procedures), orthodontic treatment and / or devices and / or medications and / or procedures and / or surgery, dental treatment and / or devices and / or retainers and / or prostheses and / or medications and / or procedures and / or surgery, endodontic treatment and / or devices and / or retainers and / or prostheses and / or medications and / or procedures and / or surgery, sleep disorder treatment and / or devices and / or retainers and / or prostheses and / or medications and / or procedures and / or surgery Surgery, dental devices and / or appliances and / or retainers and / or prostheses, bruxism treatment and / or devices and / or retainers and / or prostheses and / or medications and / or procedures and / or surgery, nasal treatment and / or devices and / or prostheses and / or medications, nasopharyngeal treatment and / or devices and / or prostheses and / or medications, nasal airway treatment and / or devices and / or retainers and / or prostheses and / or medications and / or procedures and / or surgery, oral treatment and / or devices and / or prostheses and / or retainers and / or medications, oropharyngeal treatment and / or devices and / or prostheses and / or medications, palatal treatment and / or devices and / or prostheses and / or medications, tonsil treatment and / or devices and / or prostheses and / or medications, pharyngeal lateral wall treatment and / or devices and / or prostheses Body and / or drugs, hypopharyngeal therapy and / or devices and / or prostheses and / or drugs, tongue therapy and / or devices and / or prostheses and / or drugs, tongue root therapy and / or devices and / or prostheses and / or drugs, supraglottic therapy and / or devices and / or prostheses and / or drugs, epiglottic therapy and / or devices and / or prostheses and / or drugs, and / or glottic therapy and / or devices and / or prostheses and / or drugs, subglottic therapy and / or devices and / or prostheses and / or drugs, craniofacial therapy and / or devices and / or prostheses and / or drugs, facial bone therapy and / or devices and / or prostheses and / or drugs, and / or dental therapy and / or devices and / or retainers and / or prostheses and / or drugs, neck therapy and / or devices and / or retainers and / or prostheses and / or drugs.and / or non-invasive therapies and / or devices and / or prostheses and / or drugs, neuromodulation therapies and / or devices and / or prostheses and / or drugs and / or procedures and / or surgeries and / or methods and / or systems, neurotherapy and / or devices and / or drugs and / or procedures and / or surgeries and / or methods and / or systems, and / or thyroid therapy and / or devices and / or retainers and / or prostheses and / or drugs and / or procedures and / or surgeries, and / or parathyroid therapy and / or devices and / or retainers and / or prostheses and / or drugs and / or procedures and / or Surgery, and / or salivary gland therapy and / or devices and / or retainers and / or prostheses and / or medications and / or procedures and / or surgery, and / or lymph node therapy and / or devices and / or retainers and / or prostheses and / or medications and / or procedures and / or surgery, and / or soft tissue therapy and / or devices and / or retainers and / or prostheses and / or medications and / or procedures and / or surgery, and / or connective tissue therapy and / or devices and / or retainers and / or prostheses and / or medications and / or procedures and / or surgery, and / or mucosal therapy and / or devices and / or Retainers and / or prostheses and / or medications and / or procedures and / or surgery, and / or skin therapies and / or devices and / or retainers and / or prostheses and / or medications and / or procedures and / or surgery, and / or skull base therapies and / or devices and / or retainers and / or prostheses and / or medications and / or procedures and / or surgery, and / or sinus therapies and / or devices and / or retainers and / or prostheses and / or medications and / or procedures and / or surgery, and / or orbital therapies and / or devices and / or retainers and / or prostheses and / or medications and / or procedures and / or surgery This includes, and / or ocular therapies and / or devices and / or retainers and / or prostheses and / or drugs and / or procedures and / or surgeries, and / or vascular therapies and / or devices and / or retainers and / or prostheses and / or drugs and / or procedures and / or surgeries, and / or neurotherapies and / or devices and / or retainers and / or prostheses and / or drugs and / or procedures and / or surgeries, and / or any therapy and / or device and / or prosthesis and / or drug and / or procedure and / or surgery and / or method and / or system aimed at treating tumors, and / or any combination thereof. The foregoing is merely a few examples of therapies and / or devices and / or prostheses and / or drugs and / or procedures and / or surgeries and / or methods and / or systems for treating tumors; however, the embodiments of the invention described below are not necessarily limited to the above-described therapies and / or devices and / or prostheses and / or drugs and / or procedures and / or surgeries and / or methods and / or systems, and / or any combination thereof.

[0109] 3. Methods and systems for neural modulation

[0110] 3.A. Neural Modulation Methods

[0111] This disclosure provides methods and systems for treating sleep-disordered breathing (SDB), a condition characterized by apnea or disturbance of breathing during sleep. A common form of SDB is obstructive sleep apnea (OSA), characterized by recurrent airway obstruction during sleep leading to limited or stopped airflow. This condition can lead to a variety of health risks, including hypertension, cerebrovascular events, cardiovascular events, and metabolic disorders such as diabetes. Current treatment options, such as continuous positive airway pressure (CPAP) therapy and surgical intervention, may not be effective for all patients, and adherence to these treatments can be challenging.

[0112] The disclosed methods and systems address these challenges by delivering neuromodulatory signals to specific nerves or muscles associated with the palate and pharyngeal regions. These signals can activate these nerves or muscles, thereby increasing their tone and reducing or preventing airway obstruction. This approach could provide a novel and effective treatment for OSA patients, particularly those with complete concentric palatal collapse (CCCp), a phenotype associated with greater disease severity and a higher propensity for CPAP failure.

[0113] Neuromodulation signals can be delivered using various forms of energy, including electrical, magnetic, ultrasonic, piezoelectric, radiation, electromagnetic, radio frequency, mechanical, chemical, optical, or acoustic energy, or any combination thereof. Signals can be delivered continuously or in successive pulse trains, and modulation parameters can be adjusted to optimize treatment outcomes for each patient. The disclosed methods and systems can be incorporated into various types of devices, including oral appliances, implantable devices, and wearable devices, providing patients with flexibility and convenience.

[0114] In some embodiments, the disclosed methods and systems can also be used to treat other conditions that may benefit from neuromodulation, including central sleep apnea, sleep disorders, hypertension, hypotension, autonomic dysfunction, heart rate regulation, blood pressure regulation, and various other conditions. Therefore, the disclosed methods and systems can provide a versatile and effective approach for treating a variety of conditions associated with neuromuscular control and function.

[0115] refer to Figure 1 The flowchart illustrates method 100 for treating sleep-disordered breathing. Method 100 begins at box 102, which relates to delivering neurally modulated signals to a target site. The target site may be located near a nerve or muscle associated with the palatine and / or pharyngeal muscle tissue. The nerve may be one or a combination of the lesser palatine nerve, the tensor veli palatine nerve, or branches of the pharyngeal plexus innervating the levator veli palatine, palatopharyngeal, palatoglossus, middle retractor, and / or superior retractor muscles. The muscle may be one or a combination of the levator veli palatine, uvula, palatopharyngeal, palatoglossus, tensor veli palatine, middle retractor, and / or superior retractor muscles.

[0116] Neural modulation signals can be delivered via at least one electrode positioned to communicate electrically with a target site. The electrode can be activated to deliver electrical signals to the target site, as indicated by box 104. The electrical signals can stimulate motor neurons of the target nerve or muscle fibers of the target muscle, thereby activating the palatal and pharyngeal muscle tissue. Activation of these muscles can increase their tone, reducing or preventing airway obstruction during sleep.

[0117] Method 100 ends with box 106, which relates to improving sleep-disordered breathing in patients via the delivery of neurally modulated signals. Improvement in sleep-disordered breathing may manifest as a reduction in the frequency and severity of apnea or hypopnea events, improved sleep quality, reduced daytime sleepiness, and / or other improvements in the patient's condition. Therefore, Method 100 provides a novel and effective method for treating sleep-disordered breathing, particularly in patients with obstructive sleep apnea and other forms of sleep-disordered breathing.

[0118] refer to Figure 2 The flowchart illustrates method 200 for treating sleep-disordered breathing. Method 200 begins at box 202, which relates to delivering neurally modulated signals to a target site. The target site may be located near a specific palatine and / or pharyngeal muscle. The specific muscle may include one or a combination of the levator veli palatini, uvula, palatopharynx, palatoglossus, tensor veli palatini, middle retractor, and / or superior retractor.

[0119] Neural modulation signals can be delivered via at least one electrode positioned to communicate electrically with a target site. The electrode can be activated to deliver electrical signals to the target site, as indicated by box 204. The electrical signals can stimulate muscle fibers of the target muscle, thereby activating the palatal and pharyngeal muscle tissue. Activation of these muscles can increase their tone, reducing or preventing airway obstruction during sleep.

[0120] Method 200 ends with box 206, which relates to improving sleep-disordered breathing in patients via the delivery of neurally modulated signals. Improvement in sleep-disordered breathing can manifest as a reduction in the frequency and severity of apnea or hypopnea events, improved sleep quality, reduced daytime sleepiness, and / or other improvements in the patient's condition. Therefore, method 200 provides a novel and potentially effective approach for treating sleep-disordered breathing, particularly in patients with obstructive sleep apnea and other forms of sleep-disordered breathing.

[0121] refer to Figure 3The flowchart illustrates method 300 for treating sleep-disordered breathing through a two-stage neuromodulation process. Method 300 begins at box 302, which relates to delivering neuromodulation signals to a target site near one or a combination of nerves innervating the muscular tissues of the palate and / or pharynx. These nerves may include the lesser palatine nerve, the tensor veli palatine nerve, and branches of the pharyngeal plexus innervating the levator veli palatine, palatopharyngeal, palatoglossus, middle retractor, and / or superior retractor muscles.

[0122] Following the delivery of neural regulatory signals, the muscles of the palate and pharynx are activated, as indicated by box 304. This activation can increase the tone of these muscles, thereby reducing or preventing airway obstruction during sleep.

[0123] Method 300 then proceeds to box 306, which involves delivering neural modulation signals to a target site near one or a combination of specific palatine and pharyngeal muscles. These muscles may include the levator veli palatini, uvula, palatopharynx, palatoglossus, tensor veli palatini, middle retractor, and / or superior retractor.

[0124] Following the delivery of neuromodulatory signals, the palatal and pharyngeal muscles are reactivated, as indicated by box 308. This second phase of muscle activation can further increase the tension of these muscles, thereby enhancing the reduction or prevention of airway obstruction.

[0125] Method 300 ends with box 310, which relates to improving sleep-disordered breathing in patients via the delivery of neurally modulated signals. Improvement in sleep-disordered breathing may manifest as a reduction in the frequency and severity of apnea or hypopnea events, improved sleep quality, reduced daytime sleepiness, and / or other improvements in the patient's condition. Therefore, method 300 provides a novel and potentially effective method for treating sleep-disordered breathing, particularly in patients with obstructive sleep apnea and other forms of sleep-disordered breathing.

[0126] refer to Figure 4 This image illustrates an anatomical diagram of the muscles and associated nerves of the palate and pharynx. Label 400 illustrates the various muscles and nerves involved in the upper airway. The hard palate 410 is depicted at the top of the image. The tensor veli palatine (TVP) muscle 412 and levator veli palatine (LVP) muscle 414 are shown extending from the hard palate region.

[0127] The tensor veli palatini nerve (N to the TVP) 416 branches from the mandibular branch of the trigeminal nerve (V3) 418. The lesser palatine nerve (LPN) 408 is shown innervating the palatal region. The uvula muscle (MU) 434 is depicted in the central region. The palatopharyngeal (PP) muscle 436 and the palatoglossal (PG) muscle 406 are shown extending downwards.

[0128] The superior constrictor (SC) muscle 432 and the middle constrictor (MC) muscle 430 are illustrated in the pharyngeal region. Branches to these muscles are shown, including branch 422 to the SC and branch 428 to the MC. The pharyngeal plexus is represented by PhPlex-X left 404, PhPlex-IX left 402, PhPlex-X right 424, and PhPlex-IX right 426. These nerves innervate various structures in the pharyngeal region. Additional nerve branches are depicted, including branch 420 to the LVP, which innervates the levator veli palatini muscle.

[0129] In some aspects, a method for treating sleep-disordered breathing may involve placing at least one electrode in electrical communication with target sites of the palatine muscles, pharyngeal muscles, and / or nerves innervating the palatine muscles and / or pharyngeal muscles. The target sites may be selected to target one or a combination of the following: tensor veli palatini, levator veli palatini, palatopharyngeal muscles, palatoglossus muscles, uvula muscles, superior retractor muscles, and / or middle retractor muscles.

[0130] In some cases, the target site may be selected to target one or a combination of the following: a branch of the maxillary branch of the trigeminal nerve that innervates the levator palatine muscle including the lesser palatine nerve; the palatopharyngeal muscle including the lesser palatine nerve; the palatoglossus muscle including the lesser palatine nerve; the uvula muscle including the lesser palatine nerve; a branch of the mandibular branch of the trigeminal nerve that innervates the tensor palatine muscle, the branches of which include the tensor palatine nerve; a branch of the pharyngeal plexus that innervates the superior constrictor muscle, the branches of which include pharyngeal plexus branches to the superior constrictor muscle; and / or the nerves of the superior constrictor muscle.

[0131] In some embodiments, activating at least one electrode to deliver an electrical signal to a target site includes stimulating motor neurons of one or a combination of the following: a maxillary branch of the trigeminal nerve innervating the levator veli palatini, palatoglossus, palatopharynx, and uvula, the maxillary branch including motor neurons of the lesser palatine nerve; a mandibular branch of the trigeminal nerve innervating the tensor veli palatini, the mandibular branch including motor neurons of the tensor veli palatini nerve; and a branch of the pharyngeal plexus innervating the superior constrictor muscle, the branch of the pharyngeal plexus including motor neurons of the superior constrictor nerve.

[0132] In some cases, the target site is one of multiple target sites of a nerve or muscle connected to one or more palatine and / or pharyngeal muscles. Multiple target sites can be selected to target a group including one or more of the following: tensor veli palatini, levator veli palatini, palatopharynx, palatoglossus, uvula, superior retractor and / or middle retractor.

[0133] refer to Figure 5 The diagram illustrates an oral cavity view 500 of the palate and pharyngeal muscle tissue. It shows both a frontal view of the open mouth and a detailed view of the soft palate structure. The palatopharyngeal muscle 502 is depicted as extending vertically along the side of the pharynx. Adjacent to it is the tonsil 504. The palatoglossus muscle 506 is shown connecting the soft palate to the tongue.

[0134] The micropalatine foramen 508 is indicated in the hard palate region. The levator veli palatini 510 and tensor veli palatini 512 are illustrated as extending from the base of the skull to the soft palate. The uvula muscle 514 is depicted as forming the uvula at the center of the soft palate. The palatine aponeurosis 516 is shown as a fibrous sheet in the soft palate, serving as an attachment point for multiple muscles.

[0135] In some aspects, a method for treating sleep-disordered breathing may involve placing at least one electrode in electrical communication with target sites of the palatine muscles, pharyngeal muscles, and / or nerves innervating the palatine muscles and / or pharyngeal muscles. The target sites may be selected to target one or a combination of the following: tensor veli palatini 512, levator veli palatini 510, palatopharyngeal muscles 502, palatoglossus muscles 506, uvula muscles 514, superior and / or middle retractors.

[0136] In some cases, electrical signals can be delivered to target sites, which are selected to target one or a combination of the following: tensor veli palatini 512, superior retractor, and / or middle retractor. The electrical signals can stimulate the muscle fibers of the target muscles, thereby activating the palatal and pharyngeal muscle tissue. Activation of these muscles can increase their tone, potentially reducing or preventing airway obstruction during sleep.

[0137] refer to Figure 6 The flowchart illustrates method 600 for treating sleep-disordered breathing by targeting intrinsic or extrinsic muscles of the tongue. Method 600 begins at box 602, which relates to delivering neuromodulation signals to a target site proximate to one or a combination of the intrinsic or extrinsic muscles of the tongue. The intrinsic muscles of the tongue may include superior longitudinal, inferior longitudinal, transverse, and / or vertical muscles. The extrinsic muscles of the tongue may include the genioglossus, hyoidoglossus, and / or styloglossus.

[0138] Neuromodulation signals can be delivered via at least one electrode positioned to communicate electrically with a target site. The electrode can be activated to deliver electrical signals to the target site, as indicated by box 604. The electrical signals can stimulate muscle fibers of the target muscle, thereby activating intralingual and / or extralingual muscle tissue. Activation of these muscles can increase their tone, reducing or preventing airway obstruction during sleep.

[0139] Method 600 ends with box 606, which relates to improving sleep-disordered breathing in patients via the delivery of neurally modulated signals. Improvement in sleep-disordered breathing can manifest as a reduction in the frequency and severity of apnea or hypopnea events, improved sleep quality, reduced daytime sleepiness, and / or other improvements in the patient's condition. Therefore, method 600 provides a novel and potentially effective method for treating sleep-disordered breathing, particularly in patients with obstructive sleep apnea and other forms of sleep-disordered breathing.

[0140] refer to Figure 7The image provides an anatomical illustration of the tongue 700, showing both sagittal and anterior views of the tongue and surrounding structures. The sagittal view on the left depicts the internal muscular structures of the tongue, while the anterior view on the right shows the external muscles of the tongue.

[0141] In a sagittal view, the superior longitudinal muscle 718, inferior longitudinal muscle, transverse muscle 720, and vertical muscle 712, along with the mandible 710, geniohyoid muscle 716, and geniohyoid muscle 702, are shown as the intrinsic muscles of the tongue. These muscles are responsible for changing the shape of the tongue, allowing it to change its position and shape to perform various functions such as speech and swallowing. In some aspects, methods for treating sleep-disordered breathing may involve delivering neuromodulatory signals to target sites near one or more of these intrinsic tongue muscles. The neuromodulatory signals can stimulate the muscle fibers of these muscles, thereby activating the intrinsic tongue muscle tissue. Activation of these muscles can increase their tone, potentially reducing or preventing airway obstruction during sleep.

[0142] The front view shows the dorsal surface 708 of the tongue and three extrinsic muscles of the tongue: the genioglossus 702, the hyoidoglossus 704, and the styloglossus 706. These muscles are shown as attachments to different parts of the tongue and surrounding structures, and are responsible for the overall movement of the tongue. For example, the genioglossus 702 protrudes the tongue, while the hyoidoglossus 704 depresses and retracts the tongue, and the styloglossus 706 pulls up the sides of the tongue to assist swallowing. In some cases, methods for treating sleep-disordered breathing may involve delivering neuromodulatory signals to target sites near one or more of these extrinsic muscles of the tongue. These neuromodulatory signals can stimulate the muscle fibers of these muscles, thereby activating the extrinsic muscle tissue. Activation of these muscles can increase their tone, potentially reducing or preventing airway obstruction during sleep.

[0143] In some embodiments, neural modulation signals can be delivered via at least one electrode positioned to communicate electrically with a target site. The electrode can be activated to deliver electrical signals to the target site, thereby stimulating motor neurons of the target nerve or muscle fibers of the target muscle. Activation of these muscles can increase their tone, reducing or preventing airway obstruction during sleep. Therefore, this method provides a novel and potentially effective approach for treating sleep-disordered breathing, particularly in patients with obstructive sleep apnea and other forms of sleep-disordered breathing.

[0144] refer to Figure 8 The flowchart illustrates method 800 for treating sleep-disordered breathing. Method 800 begins at box 802, which relates to delivering neuromodulation signals to a target site near one or a combination of nerves innervating the muscular tissues of the palate and / or pharynx. These nerves may include the lesser palatine nerve, the tensor veli palatine nerve, and branches of the pharyngeal plexus innervating the levator veli palatine, palatopharyngeal, palatoglossus, middle constrictor, and / or superior constrictor muscles.

[0145] Following the delivery of neural regulatory signals, the muscles of the palate and pharynx are activated, as indicated by box 804. This activation can increase the tone of these muscles, thereby reducing or preventing airway obstruction during sleep.

[0146] Method 800 then proceeds to box 806, which involves delivering neural modulation signals to a target site near one or a combination of specific palatine and pharyngeal muscles. These muscles may include the levator veli palatini, uvula, palatopharynx, palatoglossus, tensor veli palatini, middle retractor, and / or superior retractor.

[0147] Following the delivery of neuromodulation signals, the palatal and pharyngeal muscles are reactivated, as indicated by box 808. This second phase of muscle activation can further increase the tension of these muscles, thereby enhancing the reduction or prevention of airway obstruction.

[0148] Method 800 then proceeds to box 810, which involves delivering neural modulation signals to target sites near the hypoglossal nerve innervating the genioglossus muscle and / or the cervical loop nerve innervating the stigmata muscle. This leads to box 812, which involves activating the genioglossus muscle and / or the stigmata muscle.

[0149] Finally, method 800 concludes with box 814, which relates to improving sleep-disordered breathing in patients via the delivery of neurally modulated signals. Improvement in sleep-disordered breathing can manifest as a reduction in the frequency and severity of apnea or hypopnea events, improved sleep quality, reduced daytime sleepiness, and / or other improvements in the patient's condition. Therefore, method 800 provides a novel and effective method for treating sleep-disordered breathing, particularly in patients with obstructive sleep apnea and other forms of sleep-disordered breathing.

[0150] refer to Figure 9 The flowchart illustrates method 900 for treating sleep-disordered breathing through a multi-stage neuromodulation process. Method 900 begins at box 902, which relates to delivering neuromodulation signals to a target site near one or more of the nerves innervating the muscular tissues of the palate and / or pharynx. These nerves may include the lesser palatine nerve, the tensor veli palatine nerve, and branches of the pharyngeal plexus innervating the levator veli palatine, palatopharyngeal, palatoglossus, middle retractor, and / or superior retractor muscles.

[0151] Following the delivery of neural regulatory signals, the muscles of the palate and pharynx are activated, as indicated by box 904. This activation can increase the tension of these muscles, thereby potentially reducing or preventing airway obstruction during sleep.

[0152] Method 900 then proceeds to box 906, which involves delivering neural modulation signals to a target site near one or a combination of specific palatine and pharyngeal muscles. These muscles may include the levator veli palatini, uvula, palatopharynx, palatoglossus, tensor veli palatini, middle retractor, and / or superior retractor.

[0153] Following the delivery of neuromodulatory signals, the palatal and pharyngeal muscles are reactivated, as indicated by box 908. This second phase of muscle activation can further increase the tension of these muscles, thereby enhancing the reduction or prevention of airway obstruction.

[0154] Method 900 then proceeds to box 910, which relates to delivering neural modulation signals to target sites near one or a combination of intralingual muscles (such as upper longitudinal muscles, lower longitudinal muscles, transverse muscles, or vertical muscles) and / or lateral tongue muscles (such as genioglossus, hyoidoglossus, or styloglossus). This leads to box 912, which relates to activating intralingual and / or lateral tongue muscle tissue.

[0155] Finally, method 900 concludes with box 914, which relates to improving sleep-disordered breathing in patients via the delivery of neuromodulatory signals. Improvement in sleep-disordered breathing can manifest as a reduction in the frequency and severity of apnea or hypopnea events, improved sleep quality, reduced daytime sleepiness, and / or other improvements in the patient's condition. Therefore, method 900 provides a novel and effective method for treating sleep-disordered breathing, particularly in patients with obstructive sleep apnea and other forms of sleep-disordered breathing.

[0156] refer to Figure 10 The flowchart illustrates method 1000 for treating sleep-disordered breathing through a multi-stage neuromodulation process. Method 1000 begins at box 1002, which relates to delivering neuromodulation signals to a target site near one or a combination of nerves innervating the muscular tissues of the palate and / or pharynx. These nerves may include the lesser palatine nerve, the tensor veli palatine nerve, and branches of the pharyngeal plexus innervating the levator veli palatine, palatopharyngeal, palatoglossus, middle constrictor, and / or superior constrictor muscles.

[0157] Following the delivery of neural regulatory signals, the muscles of the palate and pharynx are activated, as indicated by box 1004. This activation can increase the tension of these muscles, thereby reducing or preventing airway obstruction during sleep.

[0158] Method 1000 then proceeds to box 1006, which involves delivering neural modulation signals to a target site near one or a combination of specific palatine and pharyngeal muscles. These muscles may include the levator veli palatini, uvula, palatopharynx, palatoglossus, tensor veli palatini, middle retractor, and / or superior retractor.

[0159] Following the delivery of neuromodulation signals, the palatal and pharyngeal muscles are reactivated, as indicated by box 1008. This second phase of muscle activation can further increase the tension of these muscles, thereby enhancing the reduction or prevention of airway obstruction.

[0160] Method 1000 then proceeds to box 1010, which relates to delivering neural modulation signals to target sites near one or a combination of intralingual muscles (such as upper longitudinal muscles, lower longitudinal muscles, transverse muscles, or vertical muscles) and / or lateral tongue muscles (such as genioglossus, hyoidoglossus, or styloglossus). This leads to box 1012, which relates to activating intralingual and / or lateral tongue muscle tissue.

[0161] Method 1000 then proceeds to box 1014, which relates to delivering neuromodulation signals to target sites near the hypoglossal nerve innervating the genioglossus muscle and / or the cervical loop nerve innervating the sigmata muscle. This leads to box 1016, which relates to activating the genioglossus muscle and / or the sigmata muscle.

[0162] Finally, Method 1000 concludes with box 1018, which relates to improving sleep-disordered breathing in patients via the delivery of neurally modulated signals. Improvement in sleep-disordered breathing can manifest as a reduction in the frequency and severity of apnea or hypopnea events, improved sleep quality, reduced daytime sleepiness, and / or other improvements in the patient's condition. Therefore, Method 1000 provides a novel and potentially effective method for treating sleep-disordered breathing, particularly in patients with obstructive sleep apnea and other forms of sleep-disordered breathing.

[0163] refer to Figure 11 The flowchart illustrates method 1100 for treating sleep-disordered breathing through a multi-stage neuromodulation process. Method 1100 begins at box 1102, which relates to delivering neuromodulation signals to target sites near one or more of the nerves innervating the muscular tissues of the palate and / or pharynx. These nerves may include the lesser palatine nerve, the tensor veli palatine nerve, and branches of the pharyngeal plexus innervating the levator veli palatine, palatopharyngeal, palatoglossus, middle retractor, and / or superior retractor muscles.

[0164] Following the delivery of neural regulatory signals, the muscles of the palate and pharynx are activated, as indicated by box 1104. This activation can increase the tone of these muscles, thereby reducing or preventing airway obstruction during sleep.

[0165] Method 1100 then proceeds to box 1106, which involves delivering neural modulation signals to a target site near one or a combination of specific palatine and pharyngeal muscles. These muscles may include the levator veli palatini, uvula, palatopharynx, palatoglossus, tensor veli palatini, middle retractor, and / or superior retractor.

[0166] Following the delivery of neuromodulatory signals, the palatal and pharyngeal muscles are reactivated, as indicated by box 1108. This second phase of muscle activation can further increase the tension of these muscles, thereby enhancing the reduction or prevention of airway obstruction.

[0167] Method 1100 then proceeds to box 1110, which relates to delivering neural modulation signals to target sites near one or a combination of intralingual muscles (such as upper longitudinal muscles, lower longitudinal muscles, transverse muscles, or vertical muscles) and / or lateral tongue muscles (such as genioglossus, hyoidoglossus, or styloglossus). This leads to box 1112, which relates to activating intralingual and / or lateral tongue muscle tissue.

[0168] Method 1100 then proceeds to box 1114, which involves delivering neural modulation signals to target sites near the hypoglossal nerve innervating the genioglossus muscle and / or the cervical loop nerve innervating the sigmata muscle. This leads to box 1116, which involves activating the genioglossus muscle and / or the sigmata muscle.

[0169] Finally, method 1100 concludes with box 1118, which relates to improving sleep-disordered breathing in patients via the delivery of neurally modulated signals. Improvement in sleep-disordered breathing can manifest as a reduction in the frequency and severity of apnea or hypopnea events, improved sleep quality, reduced daytime sleepiness, and / or other improvements in the patient's condition. Therefore, method 1100 provides a novel and potentially effective approach for treating sleep-disordered breathing, particularly in patients with obstructive sleep apnea and other forms of sleep-disordered breathing.

[0170] refer to Figure 12 The flowchart illustrates a comprehensive approach 1200 for treating sleep-disordered breathing. Approach 1200 begins at box 1202, which relates to delivering neuromodulation signals to target sites near one or more of the nerves innervating the muscular tissues of the palate and / or pharynx. These nerves may include the lesser palatine nerve, the tensor veli palatine nerve, and branches of the pharyngeal plexus innervating the levator veli palatine, palatopharyngeal, palatoglossus, middle constrictor, and / or superior constrictor muscles.

[0171] Following the delivery of neural regulatory signals, the muscles of the palate and pharynx are activated, as indicated by box 1204. This activation can increase the tone of these muscles, thereby potentially reducing or preventing airway obstruction during sleep.

[0172] Method 1200 then proceeds to box 1206, which involves delivering neural modulation signals to a target site near one or a combination of specific palatine and pharyngeal muscles. These muscles may include the levator veli palatini, uvula, palatopharynx, palatoglossus, tensor veli palatini, middle retractor, and / or superior retractor.

[0173] Following the delivery of neuromodulatory signals, the palatal and pharyngeal muscles are reactivated, as indicated by box 1208. This second phase of muscle activation can further increase the tension of these muscles, thereby enhancing the reduction or prevention of airway obstruction.

[0174] Method 1200 then proceeds to box 1210, which relates to delivering neural modulation signals to target sites near one or a combination of intralingual muscles (such as upper longitudinal muscles, lower longitudinal muscles, transverse muscles, or vertical muscles) and / or lateral tongue muscles (such as genioglossus, hyoidoglossus, or styloglossus). This leads to box 1212, which relates to activating intralingual and / or lateral tongue muscle tissue.

[0175] Method 1200 then proceeds to box 1214, which involves delivering neural modulation signals to target sites near the hypoglossal nerve innervating the genioglossus muscle and / or the cervical loop nerve innervating the stigmata muscle. This leads to box 1216, which involves activating the genioglossus muscle and / or the stigmata muscle.

[0176] Finally, method 1200 concludes with box 1218, which relates to improving sleep-disordered breathing in patients via the delivery of neurally modulated signals. Improvement in sleep-disordered breathing can manifest as a reduction in the frequency and severity of apnea or hypopnea events, improved sleep quality, reduced daytime sleepiness, and / or other improvements in the patient's condition. Therefore, method 1200 provides a comprehensive and effective approach for treating sleep-disordered breathing, particularly in patients with obstructive sleep apnea and other forms of sleep-disordered breathing.

[0177] In some respects, methods and systems for treating sleep-disordered breathing may involve delivering neuromodulatory signals to target sites. Neuromodulatory signals can take various forms, including but not limited to electrical signals, magnetic signals, ultrasound signals, piezoelectric signals, radiation signals, electromagnetic signals, radio frequency signals, mechanical signals, chemical signals, optical signals, sound signals, or any combination thereof. The choice of the form of the neuromodulatory signal can depend on various factors, such as the patient's specific anatomy, the specific type of sleep-disordered breathing being treated, the specific nerve or muscle being targeted, and the desired therapeutic effect.

[0178] In some cases, neuromodulation signals can be delivered continuously. In other cases, neuromodulation signals can be delivered in successive bursts of pulses. These bursts can take various forms, including but not limited to square waves, sine waves, triangular waves, exponential waves, sawtooth waves, pulse waves, or any other suitable waveform. The choice of pulse form can depend on various factors, such as the patient's specific anatomy, the specific type of sleep apnea being treated, the specific nerve or muscle being targeted, and the desired therapeutic effect.

[0179] In some embodiments, neural modulation signals can be delivered using varying modulation parameters. These modulation parameters may include, but are not limited to, current amplitude, voltage amplitude, frequency, pulse width, duty cycle, pulse configuration, or any combination thereof. The modulation parameters can be adjusted to optimize treatment outcomes for each patient. For example, the current amplitude, voltage amplitude, frequency, pulse width, duty cycle, and pulse configuration can all be adjusted to achieve a desired level of neural or muscle activation.

[0180] In some embodiments, methods and systems for treating sleep-disordered breathing can be configured as closed-loop systems. In a closed-loop system, the system may include sensors for sensing, measuring, and monitoring physiological parameters and / or sleep and / or sleep apnea and / or breathing surrogate. The sensed, measured, and monitored data can be used to adjust the delivery of neural modulation signals in real time, thereby providing dynamic and responsive treatment for sleep-disordered breathing.

[0181] In other embodiments, the methods and systems for treating sleep-disordered breathing can be configured as open-loop systems. In an open-loop system, neural modulation parameters can be configured based on polysomnography data and / or data from home sleep studies and / or data from another form of sleep study. The configured neural modulation parameters can then be used to deliver neural modulation signals in a predetermined manner, thereby providing consistent and predictable treatment for sleep-disordered breathing.

[0182] In some aspects, methods and systems for treating sleep-disordered breathing may involve therapeutic delivery systems placed inside the oral cavity and / or nasal cavity and / or oropharynx and / or nasopharynx. The therapeutic delivery system may include at least one electrode configured to deliver neuromodulation signals to a target site, which may be a nerve or muscle. The therapeutic delivery system may also include a power source connected to the electrode via wired or wireless communication, and a controller communicating with the electrode. The controller may be programmed to direct the delivery of electrical or other signals through the electrode to the target site.

[0183] In some cases, a treatment delivery system may be implanted into the patient. Implantation of a treatment delivery system may involve transmucosal / transmucosal and / or percutaneous delivery techniques. Delivery techniques may involve using catheters, cannulas, sheaths, or other conduits to guide the treatment delivery system to the target site. In some embodiments, a surgical procedure may be used to implant the treatment delivery system.

[0184] In some embodiments, the treatment delivery system may include an implantable receiver, including a neurostimulator subsystem, that communicates with one or more implantable electrodes. The implantable receiver may be configured to receive signals and power from an oral appliance subsystem. The signals and power may be transmitted from the oral appliance subsystem to the implantable receiver via a wired or wireless communication link. The implantable receiver may then deliver the neuromodulation signals to a target site via one or more implantable electrodes.

[0185] In some cases, the target site may be located near the nerves innervating the palatine and / or pharyngeal muscles. These nerves may be one or a combination of the lesser palatine nerve, the tensor veli palatine nerve, and branches of the pharyngeal plexus innervating the levator palatine veli, palatopharyngeal muscles, palatoglossus muscles, middle constrictor muscles, and / or superior constrictor muscles. Electrodes may be positioned to deliver neuromodulatory signals to the target site in a manner that activates the nerves, thereby increasing the tone of the innervated muscles and potentially reducing or preventing airway obstruction during sleep.

[0186] In other cases, the target site can be a muscle that is a palatine and / or pharyngeal muscle. This muscle can be one or a combination of the levator veli palatini, uvula, palatopharynx, palatoglossus, tensor veli palatini, middle retractor, and / or superior retractor. Electrodes can be positioned to deliver neuromodulatory signals to the target site in a manner that activates the muscle, thereby increasing its tone and potentially reducing or preventing airway obstruction during sleep.

[0187] 3.B. Neural Modulation and Delivery System

[0188] This disclosure provides methods and systems for treating sleep-disordered breathing (SDB) conditions, such as obstructive sleep apnea (OSA), by delivering neuromodulation signals to specific nerves or muscles associated with the airway. The disclosed methods and systems may involve the use of an oral appliance subsystem, which may include one or more electrodes, a pulse generator, and a rechargeable battery. The electrodes may be configured to deliver neuromodulation signals to target sites near certain nerves or muscles in the oral cavity, nasal cavity, oropharynx, and / or nasopharynx. These target sites may include, but are not limited to, the lesser palatine nerve, the tensor veli palatine nerve, branches of the pharyngeal plexus, and various muscles of the palate, pharynx, and tongue. The pulse generator, powered by the rechargeable battery, may be programmed to modulate the delivery of neuromodulation signals, which may be in the form of electrical, magnetic, ultrasonic, piezoelectric, radiation, electromagnetic, radio frequency, mechanical, chemical, optical, acoustic signals, or any combination thereof. The delivery of these signals may activate the motor fibers of the target nerves and / or the muscle fibers of the target muscles, thereby increasing their tension and potentially improving the patient's sleep-disordered breathing. The disclosed methods and systems provide new approaches to treating SDB, particularly for patients with certain OSA phenotypes who are not well treated with existing therapies.

[0189] refer to Figure 13System diagram 1300 illustrates a non-implantable neurostimulation system for treating sleep-disordered breathing. The system includes a remote control 1302, a retainer 1304, a pulse generator 1306, electrodes 1308, a charger 1310, a battery 1312, and an optional sensor 1314.

[0190] Remote controller 1302 is a handheld device that allows a user (such as a patient or healthcare provider) to control the operation of pulse generator 1306. Remote controller 1302 may include buttons, switches, or other user interface elements for adjusting parameters of the neural modulation signal, such as its amplitude, frequency, pulse width, and duty cycle. Remote controller 1302 may communicate with pulse generator 1306 via a wired or wireless connection.

[0191] The retainer 1304 is a device designed to be worn in the oral cavity. It can be customized to fit the patient's dental arch and may include features for securing it in place, such as clips or suction elements. The retainer 1304 houses the battery 1312 and connects to the pulse generator 1306.

[0192] The pulse generator 1306 is a device for generating neural modulation signals. It is powered by a battery 1312 and communicates electrically with electrodes 1308. The pulse generator 1306 can be programmed to generate neural modulation signals with specific parameters, such as a specific frequency, amplitude, pulse width, and duty cycle. These parameters can be adjusted based on input from a remote control 1302.

[0193] The pulse generator 1306 may include a sophisticated microcontroller or control unit that allows for the programming, monitoring, and adjustment of various stimulation parameters. The control unit can receive input from sensors, controllers, and batteries to optimize stimulation delivery. In some aspects, the microcontroller may utilize adaptive algorithms to dynamically adjust the stimulation parameters based on real-time feedback from sensors or user input via a remote control.

[0194] The pulse generator 1306 may also include a dedicated pulse generation circuit that generates electrical pulses with specific parameters such as amplitude, pulse width, frequency, and waveform shape. This circuit can receive instructions from a microcontroller and draw power from a battery to generate the desired stimulation pulses. In some cases, the pulse generator may be able to generate complex waveforms or multiple independent stimulation channels.

[0195] The pulse generator 1306 can be further incorporated into an output stage or amplifier, which amplifies the generated pulses and drives current through the electrodes. This stage ensures that the stimulation pulses have sufficient power to effectively stimulate the target tissue while maintaining safety limits.

[0196] In some respects, the pulse generator 1306 may be a single integrated unit (e.g., a single printed circuit board) that encompasses multiple functions.

[0197] Electrode 1308 is a component that delivers neural modulation signals to a target site. Electrode 1308 can be positioned within retainer 1304 such that the electrode is close to the target site when the retainer wears out. Electrode 1308 can be wirelessly or wired with pulse generator 1306.

[0198] Charger 1310 is a device for recharging battery 1312. Charger 1310 may be a separate device connected to retainer 1304, or it may be integrated into retainer. Charger 1310 may use various methods to deliver power to battery 1312, such as inductive charging, direct electrical connection, or other suitable methods.

[0199] Battery 1312 is the power source for pulse generator 1306. Battery 1312 may be a rechargeable battery that can be recharged using charger 1310. Battery 1312 may be housed within holder 1304.

[0200] Sensor 1314 is an optional component that may be included in some embodiments of the system. Sensor 1314 may be configured to sense physiological and / or anatomical parameters and generate sensor signals based on the sensed parameters. Sensor 1314 may be wired or wirelessly connected to pulse generator 1306. A controller, which may be part of pulse generator 1306, may be programmed to guide the delivery of electrical signals to the target site via electrode 1308 based on the sensor signals.

[0201] In some cases, the system can be configured as a closed-loop system. In a closed-loop system, sensor 1314 senses physiological parameters related to the patient's sleep apnea, such as airflow, oxygen saturation, or muscle activity. Sensor 1314 generates sensor signals based on these parameters, and the controller adjusts the parameters of the neuromodulation signals based on these sensor signals. This allows the system to automatically adjust neuromodulation therapy in response to changes in the patient's condition.

[0202] In other cases, the system can be configured as an open-loop system. In an open-loop system, the parameters of the neural modulation signals are set based on data from polysomnography or other sleep studies. The controller guides the delivery of the neural modulation signals based on these preset parameters. Open-loop systems may be suitable for patients with relatively stable and predictable sleep apnea characteristics.

[0203] refer to Figure 14System diagram 1400 illustrates an implantable neurostimulation system for treating sleep-disordered breathing. The system includes a remote controller 1402, a delivery system 1404, a holder 1406, a pulse generator 1408, electrodes 1410, a charger 1412, a battery 1414, and an optional sensor 1416.

[0204] Remote controller 1402 is a handheld device that allows a user (such as a patient or healthcare provider) to control the operation of pulse generator 1408. Remote controller 1402 may include buttons, switches, or other user interface elements for adjusting parameters of the neural modulation signal, such as its amplitude, frequency, pulse width, and duty cycle. Remote controller 1402 may communicate with pulse generator 1408 via a wired or wireless connection.

[0205] The delivery system 1404 is an implantable device including at least one electrode 1410. The electrode 1410 is a submucosal implantable electrode configured to deliver neuromodulation signals to a target site. The delivery system 1404 can be implanted using various methods, such as percutaneous delivery, transmucosal delivery, or surgical placement.

[0206] The retainer 1406 is a device designed to be worn in the oral cavity. It can be custom-fitted to fit the patient's dental arch and may include features for securing it in place, such as clips or suction elements. The retainer 1406 houses a battery 1414 connected to a pulse generator 1408.

[0207] The pulse generator 1408 is a device for generating neural modulation signals. It is powered by a battery 1414 and communicates electrically with electrodes 1410. The pulse generator 1408 can be programmed to generate neural modulation signals with specific parameters, such as a specific frequency, amplitude, pulse width, and duty cycle. These parameters can be adjusted based on input from a remote controller 1402.

[0208] Charger 1412 is a device for recharging battery 1414. Charger 1412 may be a separate device connected to retainer 1406, or it may be integrated into retainer. Charger 1412 may use various methods to deliver power to battery 1414, such as inductive charging, direct electrical connection, or other suitable methods.

[0209] Battery 1414 is a power source for pulse generator 1408. Battery 1414 may be a rechargeable battery that can be recharged using charger 1412. Battery 1414 may be housed within holder 1406.

[0210] Sensor 1416 is an optional component that may be included in some embodiments of the system. Sensor 1416 may be configured to sense physiological and / or anatomical parameters and generate sensor signals based on the sensed parameters. Sensor 1416 may be wired or wirelessly connected to pulse generator 1408. A controller, which may be part of pulse generator 1408, may be programmed to guide the delivery of electrical signals to the target site via electrode 1410 based on the sensor signals.

[0211] In some cases, the system can be configured as a closed-loop system. In a closed-loop system, sensor 1416 senses physiological parameters related to the patient's sleep apnea, such as airflow, oxygen saturation, or muscle activity. Sensor 1416 generates sensor signals based on these parameters, and the controller adjusts the parameters of the neuromodulation signals based on these sensor signals. This allows the system to automatically adjust neuromodulation therapy in response to changes in the patient's condition.

[0212] In other cases, the system can be configured as an open-loop system. In an open-loop system, the parameters of the neural modulation signals are set based on data from polysomnography or other sleep studies. The controller guides the delivery of the neural modulation signals based on these preset parameters. Open-loop systems may be suitable for patients with relatively stable and predictable sleep apnea characteristics.

[0213] refer to Figure 15 This paper describes an oral appliance 1500 designed for use in the oral cavity. The oral appliance 1500 integrates multiple components into a prosthetic structure, providing a compact and convenient solution for delivering nerve stimulation therapy in the oral cavity.

[0214] The oral appliance 1500 includes a pulse generator and electrodes 1502, a battery 1504, and a prosthetic structure 1506. The pulse generator and electrodes 1502 are positioned within the prosthetic structure 1506. The pulse generator and electrodes 1502 are responsible for generating neuromodulation signals and delivering them to target nerves or muscles. The battery 1504, which provides power to the pulse generator and electrodes 1502, is also integrated into the prosthetic structure 1506.

[0215] The prosthetic structure 1506 forms the body of the dental appliance 1500. It is designed to conform to the user's dental arch, providing a comfortable and secure fit. The prosthetic structure 1506 can be customized to fit the patient's dental arch and may include features for securing it in place, such as snap-fit ​​or suction elements.

[0216] Lead wire 1508 is shown as connecting prosthesis structure 1506 to the oral cavity. Lead wire 1508 provides a conduction pathway for neuromodulation signals from the pulse generator and electrode 1502 to the target nerve or muscle.

[0217] In some cases, the dental appliance 1500 can be configured as a closed-loop system. In a closed-loop system, the dental appliance 1500 may include sensors ( Figure 15 (Not shown in the image), the sensor is configured to sense physiological and / or anatomical parameters and generate sensor signals based on the sensed parameters. A controller, which may be part of a pulse generator and electrode 1502, can be programmed to guide the delivery of electrical signals through the electrodes to the target site based on the sensor signals. This allows the system to automatically adjust neuromodulation therapy in response to changes in the patient's condition.

[0218] In other cases, the oral appliance 1500 can be configured as an open-loop system. In an open-loop system, the parameters of the neural modulation signals are set based on data from polysomnography or other sleep studies. The controller guides the delivery of the neural modulation signals based on these preset parameters. Open-loop systems may be suitable for patients with relatively stable and predictable sleep apnea characteristics.

[0219] In some respects, the oral appliance 1500 can be designed to be removable, allowing the patient to easily insert and remove the appliance as needed. This provides the patient with greater flexibility and comfort, and facilitates the cleaning and maintenance of the appliance.

[0220] In some cases, the oral appliance 1500 can be designed to be adjustable, allowing for customized fit and positioning to suit the individual patient's anatomy and comfort preferences. This can enhance the effectiveness of neuromodulation therapy by ensuring optimal positioning of the electrode 1502 relative to the target nerve or muscle.

[0221] In some respects, the oral appliance 1500 can be designed to be worn during sleep, providing neuromodulation therapy to improve sleep-disordered breathing during sleep. This could offer a convenient and non-invasive treatment option for patients with sleep-disordered breathing conditions such as obstructive sleep apnea.

[0222] In some cases, the oral appliance 1500 can be designed for use in conjunction with other treatments for sleep-disordered breathing, such as continuous positive airway pressure (CPAP), mandibular advancement devices, or surgical interventions. This could provide a comprehensive and multifaceted approach to treating sleep-disordered breathing.

[0223] In some respects, the oral appliance 1500 can be designed for use in a variety of settings, including at home, in a sleep laboratory, in a hospital, or in other medical facilities. This provides patients with flexibility and convenience, allowing them to receive neuromodulation therapy in the most convenient and comfortable location.

[0224] In some cases, the oral appliance 1500 can be designed for use by a wide range of patients, including adults, children, and individuals with varying degrees of sleep apnea severity. This can provide a versatile and adaptive treatment option that can be customized to meet the specific needs of each individual patient.

[0225] In some respects, the oral appliance 1500 can be designed for both diagnostic and therapeutic purposes. For example, the oral appliance 1500 can be used to monitor a patient's sleep-disordered breathing patterns and adjust neuromodulation therapy parameters accordingly, thereby providing personalized and adaptive treatment methods.

[0226] In some cases, the oral appliance 1500 can be designed for long-term treatment of sleep-disordered breathing. The oral appliance 1500 can be durable and designed for reusability, thus providing a sustainable and lasting treatment option for patients with chronic sleep-disordered breathing.

[0227] In some respects, the oral appliance 1500 can be designed for short-term treatment of sleep-disordered breathing, such as during acute exacerbations or worsening of the condition. This can provide a rapid and effective treatment option for patients experiencing acute symptoms of sleep-disordered breathing.

[0228] In some cases, the oral appliance 1500 can be designed as a stand-alone treatment for sleep-disordered breathing, providing a non-invasive and convenient alternative to other treatment options such as CPAP therapy or surgery.

[0229] In some respects, the oral appliance 1500 can be designed to be used as part of a comprehensive treatment plan for sleep-disordered breathing, in conjunction with other treatments such as lifestyle modifications, medication, or other therapies. This can provide a holistic and multifaceted approach to treating sleep-disordered breathing.

[0230] refer to Figure 15 The oral appliance 1500 can be secured within the patient's mouth using various attachment methods and configurations. In some cases, the oral appliance 1500 can be molded to fit the patient's palate, mandible, or dentition. This customized fit design ensures a safe and comfortable fit, allowing the oral appliance 1500 to remain in place during sleep and deliver effective neuromodulation therapy.

[0231] In other cases, the oral appliance 1500 can be mechanically attached to the patient's craniofacial anatomy. For example, the oral appliance 1500 can be attached using wires or other mechanical fasteners. This mechanical attachment can provide safe and stable positioning of the oral appliance 1500, ensuring consistent delivery of neuromodulation signals to the target nerve or muscle.

[0232] In some respects, the oral appliance 1500 can be attached to the oral cavity, pharynx, or nasal mucosa. This may involve the use of adhesives or other suitable attachment methods. By attaching the oral appliance 1500 to the mucosa, the appliance can be positioned close to a target nerve or muscle, thereby facilitating the effective delivery of neuromodulation signals.

[0233] In some cases, the oral appliance 1500 can be designed using a combination of these attachment methods. For example, the oral appliance 1500 can be custom-molded to fit the patient's dentition and also mechanically attached to the patient's craniofacial anatomy. This combination of attachment methods can provide a safe and comfortable fit while ensuring optimal positioning of the oral appliance 1500 for effective delivery of neuromodulation therapy.

[0234] In some respects, the oral appliance 1500 can be designed to be easily removable, allowing the patient to insert and remove the appliance as needed. This provides the patient with greater flexibility and comfort, and facilitates the cleaning and maintenance of the appliance.

[0235] In some cases, the oral appliance 1500 can be designed to be adjustable, allowing for customized fit and positioning to suit the individual patient's anatomy and comfort preferences. This can enhance the effectiveness of neuromodulation therapy by ensuring optimal positioning of the electrode 1502 relative to the target nerve or muscle.

[0236] refer to Figure 16A The text describes an oral appliance 1600A designed for use in the oral cavity. The oral appliance 1600A integrates multiple components into a prosthesis structure 1606, providing a compact and convenient solution for delivering nerve stimulation therapy in the oral cavity.

[0237] The oral appliance 1600A includes a pulse generator and electrode 1602, a battery 1604, and a prosthetic structure 1606. The pulse generator and electrode 1602 are positioned within the prosthetic structure 1606. The pulse generator and electrode 1602 are responsible for generating neuromodulation signals and delivering them to target nerves or muscles. The battery 1604, which provides power to the pulse generator and electrode 1602, is also integrated into the prosthetic structure 1606.

[0238] The prosthetic structure 1606 forms the body of the dental appliance 1600A. It is designed to conform to the user's dental arch, providing a comfortable and secure fit. The prosthetic structure 1606 can be customized to fit the patient's dental arch and may include features for securing it in place, such as snap-fit ​​or suction elements.

[0239] A lead wire 1608 is shown connecting the prosthesis structure 1606 to the oral cavity. The lead wire 1608 provides a conduction pathway for neuromodulation signals from the pulse generator and electrode 1602 to the target nerve or muscle.

[0240] In some respects, the 1600A dental appliance can be designed to be removable, allowing patients to easily insert and remove the appliance as needed. This provides patients with greater flexibility and comfort, and facilitates the cleaning and maintenance of the appliance.

[0241] In some cases, the oral appliance 1600A can be designed to be adjustable, allowing for customized fit and positioning to suit the individual patient's anatomy and comfort preferences. This can enhance the effectiveness of neuromodulation therapy by ensuring optimal positioning of the electrode 1602 relative to the target nerve or muscle.

[0242] In some respects, the oral appliance 1600A can be designed to deliver neuromodulation signals via the oral cavity. In this case, the electrode 1602 can be positioned intraorally, close to the target nerve or muscle. This can allow for the direct delivery of neuromodulation signals to the target nerve or muscle, potentially enhancing the effectiveness of treatment.

[0243] In other cases, the oral appliance 1600A can be designed to deliver neuromodulation signals via the nasal route. In this case, the electrode 1602 can be positioned within the nasal cavity, close to the target nerve or muscle. This allows for the direct delivery of neuromodulation signals to the target nerve or muscle, potentially enhancing the effectiveness of the treatment.

[0244] In some respects, the oral appliance 1600A can be designed to deliver neuromodulation signals to target sites that are nerves or muscles. These target sites can be located near nerves or muscles involved in maintaining upper airway patency, such as the palatoglossus muscle 1610 or the palatopharyngeal muscle 1612. By delivering neuromodulation signals to these target sites, the oral appliance 1600A can help improve sleep-disordered breathing in patients.

[0245] refer to Figure 16B The image depicts a side view of an oral appliance 1600B designed for use in the oral cavity. The oral appliance 1600B integrates multiple components into a prosthetic structure 1606, providing a compact and convenient solution for delivering nerve stimulation therapy in the oral cavity.

[0246] The oral appliance 1600B includes a pulse generator and electrode 1602, a battery 1604, and a prosthetic structure 1606. The pulse generator and electrode 1602 are positioned within the prosthetic structure 1606. The pulse generator and electrode 1602 are responsible for generating neuromodulation signals and delivering them to target nerves or muscles. The battery 1604, which provides power to the pulse generator and electrode 1602, is also integrated into the prosthetic structure 1606.

[0247] The prosthetic structure 1606 forms the body of the dental appliance 1600B. It is designed to conform to the user's dental arch, providing a comfortable and secure fit. The prosthetic structure 1606 can be customized to fit the patient's dental arch and may include features for securing it in place, such as snap-fit ​​or suction elements.

[0248] A lead wire 1608 is shown connecting the prosthesis structure 1606 to the oral cavity. The lead wire 1608 provides a conduction pathway for neuromodulation signals from the pulse generator and electrode 1602 to the target nerve or muscle.

[0249] In some respects, the oral appliance 1600B can be designed to be removable, allowing patients to easily insert and remove the appliance as needed. This provides patients with greater flexibility and comfort, and facilitates the cleaning and maintenance of the appliance.

[0250] In some cases, the oral appliance 1600B can be designed to be adjustable, allowing for customized fit and positioning to suit the individual patient's anatomy and comfort preferences. This can enhance the effectiveness of neuromodulation therapy by ensuring optimal positioning of the electrode 1602 relative to the target nerve or muscle.

[0251] In some respects, the oral appliance 1600B can be designed to deliver neuromodulation signals via the oral cavity. In this case, the electrode 1602 can be positioned intraorally, close to the target nerve or muscle. This can allow for the direct delivery of neuromodulation signals to the target nerve or muscle, potentially enhancing the effectiveness of treatment.

[0252] In other cases, the oral appliance 1600B can be designed to deliver neuromodulation signals via the nasal route. In this case, the electrode 1602 can be positioned within the nasal cavity, close to the target nerve or muscle. This allows for the direct delivery of neuromodulation signals to the target nerve or muscle, potentially enhancing the effectiveness of the treatment.

[0253] In some respects, the oral appliance 1600B can be designed to deliver neuromodulation signals to target sites that are nerves or muscles. Target sites may be located near nerves or muscles involved in maintaining upper airway patency, such as the palatoglossus muscle 1610 or the palatopharyngeal muscle 1612. By delivering neuromodulation signals to these target sites, the oral appliance 1600B can help improve sleep-disordered breathing in patients. Applications of delivery systems for improving upper airway patency may involve the use of an oral appliance subsystem that may include one or more electrodes, a pulse generator, and a rechargeable battery. The electrodes may be configured to deliver neuromodulation signals to target sites near certain nerves or muscles in the oral cavity, nasal cavity, oropharynx, and / or nasopharynx. These target sites may include, but are not limited to, the lesser palatine nerve, the tensor veli palatine nerve, branches of the pharyngeal plexus, and various muscles of the palate, pharynx, and tongue. The pulse generator, powered by the rechargeable battery, can be programmed to modulate the delivery of neuromodulation signals, which may be in the form of electrical, magnetic, ultrasonic, piezoelectric, radiation, electromagnetic, radio frequency, mechanical, chemical, optical, acoustic signals, or any combination thereof. The delivery of these signals can activate motor fibers of target nerves and / or muscle fibers of target muscles, thereby increasing their tension and potentially improving sleep-disordered breathing in patients. The disclosed methods and systems can provide new approaches to treating SDB, particularly for patients with certain OSA phenotypes who are not well treated with existing therapies.

[0254] refer to Figure 17 The image illustrates a perspective view of a charging and control system 1700 for dental appliances. The system includes a charging case 1702 and a remote control 1704. The charging case 1702 has a hinged lid design and contains a compartment sized to accommodate the dental appliance 1700. The dental appliance 1700 is shown placed inside the open charging case 1702. The remote control 1704 is integrated into the lid of the charging case. The remote control 1704 includes control buttons for operating the dental appliance system. This compact design allows for convenient storage, charging, and control of the dental appliance 1700 in a single integrated unit.

[0255] In some aspects, the charging case 1702 may include a charging pad or charging bowl for wirelessly charging the dental appliance 1700. The charging pad or bowl may use tightly coupled electromagnetic resonant inductive or non-radiative charging, loosely coupled or radiative electromagnetic resonant charging, uncoupled radio frequency (RF) wireless charging, or any combination thereof to transfer energy from the charging case 1702 to the dental appliance 1700. This wireless charging feature provides a convenient and efficient way to recharge the battery of the dental appliance 1700, eliminating the need for a direct electrical connection and facilitating the use of the dental appliance 1700 in various settings.

[0256] Remote control 1704 can be used to start, stop, regulate, optimize, and modulate treatment delivered by dental appliance 1700. Remote control 1704 can communicate with dental appliance 1700 via a wired or wireless connection, allowing the user to control the operation of dental appliance 1700 remotely. Remote control 1704 may include buttons, switches, or other user interface elements for adjusting parameters of the neuromodulation signal, such as its amplitude, frequency, pulse width, and duty cycle. Remote control 1704 may also include display elements, such as an LED or LCD screen, to provide the user with visual feedback regarding the status of dental appliance 1700 and neuromodulation treatment.

[0257] In some cases, the electrical signal transmitted by the oral appliance 1700 can be activated by removing the oral appliance 1700 from the charging case 1702 and / or by pressing the activation button with a timer on the remote control 1704. This feature provides users with a convenient and intuitive way to begin neuromodulation therapy, and the timer function allows users to schedule the start of therapy to align with their sleep schedule.

[0258] In some respects, the charging case 1702 and remote control 1704 can also serve as a data management system for the dental appliance 1700. The charging case 1702 and remote control 1704 may include memory for storing data related to the use of the dental appliance 1700, such as usage time, neuromodulation parameters, sensor data, and battery charge levels. The charging case 1702 and remote control 1704 may also include data communication interfaces, such as a USB port or a wireless communication module, for transmitting the stored data to a computer or other device for further analysis or reporting. This data management feature can provide users and their healthcare providers with valuable information regarding the effectiveness of neuromodulation therapy and the usage patterns of the dental appliance 1700.

[0259] In some respects, the neuromodulation signals delivered by oral appliances can include successive pulse trains. A pulse generator, which can be integrated into the oral appliance, can be programmed to deliver varying modulation parameters, including current amplitude, voltage amplitude, frequency, pulse width, duty cycle, and pulse configuration. These parameters can be adjusted based on input from a remote control, allowing for customized neuromodulation therapy to suit the individual patient's needs and condition.

[0260] Electrical signals delivered by oral appliances can be continuous or in the form of successive pulse trains. These pulse trains can take various forms, including square waves, sine waves, triangular waves, exponential waves, sawtooth waves, pulse waves, or arbitrary waveforms. The choice of waveform can depend on the specific characteristics of the target nerve or muscle, the patient's condition, and the desired therapeutic effect.

[0261] In some cases, the delivery of electrical signals can be triggered by various mechanisms. For example, the delivery of electrical signals can be initiated by optical sensing of the device layout, proprioceptive sensing of the device layout, mechanical sensing of the device layout, humidity sensing, chemiluminescence sensing, patient physical orientation, body stillness, and / or time of day. These initiation mechanisms can provide users with a convenient and intuitive way to begin neuromodulation therapy and can also allow for automatic adjustment of treatment based on changes in the patient's condition or environment. For example, when a patient lies down to sleep, the delivery of electrical signals can be automatically initiated based on detected changes in the patient's physical orientation.

[0262] In some aspects, oral appliances 1500, 1600A, 1600B, or 1700 may include sensors 1314, 1416 configured to sense physiological and / or anatomical parameters associated with sleep-disordered breathing. Sensors 1314, 1416 may be wired or wirelessly connected to pulse generators 1306, 1408. Physiological and / or anatomical parameters that can be sensed by sensors 1314, 1416 may include, but are not limited to, acoustic vibrations, mechanical vibrations, airflow parameters, blood flow parameters, heart rate, oxygen saturation, muscle activity, and / or neural activity. These parameters can provide valuable information about a patient's sleep-disordered breathing condition and can be used to adjust parameters of neural regulatory signals to optimize treatment effectiveness.

[0263] In some cases, sensors 1314 and 1416 may be located in or near the airway, vascular system, muscle tissue, neural pathways, and / or mucosa. The specific location of sensors 1314 and 1416 may depend on the specific physiological and / or anatomical parameters sensed, and the specific nerve or muscle targeted by the neural modulation signal. For example, if sensors 1314 and 1416 are configured to sense airflow parameters, they may be located within the airway. If sensors 1314 and 1416 are configured to sense muscle activity, they may be located near the target muscle. Sensors 1314 and 1416 can be positioned in a manner that provides accurate and reliable sensing of physiological and / or anatomical parameters while minimizing discomfort or interference with the patient's normal activities.

[0264] In some aspects, a controller, which may be part of the pulse generators 1306 and 1408, can be programmed to guide the delivery of electrical signals to target sites via electrodes 1308 and 1410 based on sensor signals. The controller may include software configured to analyze the sensor signals and adjust parameters of the neuromodulation signals accordingly. For example, the controller may adjust the amplitude, frequency, pulse width, and / or duty cycle of the neuromodulation signals based on sensed changes in physiological and / or anatomical parameters. This can allow the system to automatically adjust neuromodulation therapy in response to changes in the patient's condition, potentially enhancing the effectiveness of the treatment.

[0265] In some cases, the controller can be configured to analyze sensor signals in real time, allowing for immediate adjustment of neuromodulation signals based on changes in sensed physiological and / or anatomical parameters. In other cases, the controller can be configured to store sensor signals for later analysis, allowing for retrospective adjustment of neuromodulation signals based on trends or patterns in sensed physiological and / or anatomical parameters. The specific configuration of the controller and its software can depend on the specific requirements of the neuromodulation therapy and the specific characteristics of the patient's sleep apnea.

[0266] This disclosure relates to methods and systems for treating sleep-disordered breathing, such as obstructive sleep apnea. These methods and systems may involve delivering neuromodulation signals to specific nerves or muscles associated with airway obstruction during sleep. The neuromodulation signals may be delivered via one or more electrodes configured to target specific sites within the oral cavity and / or nasal cavity, oropharynx and / or nasopharynx. The delivery system may include a power source and a controller that can be programmed to direct the delivery of the neuromodulation signals. The system may also include sensors for monitoring various physiological parameters, thereby enabling personalized treatment and improved patient compliance. This disclosure further covers methods and systems for treating sleep-disordered breathing by delivering neuromodulation signals to target sites, wherein the target sites are palatine and / or pharyngeal muscles, or nerves innervating the palatine and / or pharyngeal muscles. This disclosure also provides methods and systems for improving sleep-disordered breathing in patients by neuromodulating the activation of palatine and pharyngeal muscle tissue. These methods and systems may be designed, made, constructed, constructed, formed, assembled, shaped, molded, fabricated, or produced such that electrodes are placed according to the specific patient's anatomy to achieve optimal airway opening and improvement in the patient's sleep-disordered breathing.

[0267] refer to Figure 18 This illustration shows a neuromodulation therapy system 1800 for treating sleep-disordered breathing. System 1800 includes a first electrode 1802 and a second electrode 1810. The first electrode 1802 is located on or near the palatoglossus muscle 1806 and the palatopharyngeal muscle 1808. The second electrode 1810 is located near the third molar 1820. Electrodes 1802 and 1810 are configured to deliver neuromodulation signals, as indicated by the neuromodulation flow direction 1804.

[0268] In some respects, the second electrode 1810 can be positioned at the superior medial insertion point 1812 of the palatoglossus muscle 1806, while the first electrode 1802 can be positioned in the retromolar triangle. This configuration allows neuromodulation signals to be transmitted along the length of the palatoglossus muscle 1806, thereby improving sleep-disordered breathing in patients.

[0269] In other cases, the second electrode 1810 can be positioned at the superior medial insertion point 1814 of the palatopharyngeal muscle 1808, while the first electrode 1802 can be positioned on a device component placed above the third molar 1820. This configuration allows neural modulation signals to be transmitted along the length of the palatopharyngeal muscle 1806 to a fixed point fastened to the mandibular tooth. In this embodiment, the non-conductive coating 1840 can contact the tooth, and the second electrode 1810 can be embedded in the non-conductive coating 1840. This arrangement prevents modulation by the dental pulp nerve, inferior alveolar nerve, or any nerve not intended to be modulated.

[0270] In another aspect, the first electrode 1802 can be positioned at the superior medial insertion point of the palatoglossus muscle 1806, while the second electrode 1810 can be positioned at the lingual insertion point of the palatoglossus muscle 1806. This configuration allows neuromodulation signals to be transmitted along the length of the palatoglossus muscle 1806, thereby potentially improving sleep-disordered breathing in patients.

[0271] The neuromodulation therapy system 1800 can be part of a larger system that includes a power supply and a controller. The power supply can be wired or wirelessly connected to electrodes 1802 and 1810, and the controller can communicate with electrodes 1802 and 1810. The controller can be programmed to direct the delivery of neuromodulation signals through electrodes 1802 and 1810 to a target site, which can be a nerve or muscle. The delivery of neuromodulation signals can improve sleep-disordered breathing in patients.

[0272] refer to Figure 19 The illustration shows a neuromodulation therapy system 1900 for treating sleep-disordered breathing. System 1900 includes electrodes 1912 and 1924 positioned relative to various muscles and structures of the soft palate and pharynx. Electrodes 1912 and 1924 are configured to deliver neuromodulation signals to specific target sites, as indicated by the direction of the neuromodulation flow 1922.

[0273] In some respects, electrode 1912 can be positioned near the tensor veli palatini muscle 1914. The tensor veli palatini muscle 1914 is a broad, thin, band-like muscle in the soft palate that plays a role in opening the Eustachian tube to allow for equalization of pressure between the middle ear and the atmosphere. By delivering neuromodulatory signals to this muscle, system 1900 can improve airway patency during sleep.

[0274] Electrode 1924 is positioned on or near the third molar 1926. This arrangement allows for the delivery of neuromodulation signals close to the muscles of the mouth and pharynx, potentially improving sleep-disordered breathing in patients.

[0275] System 1900 also depicts various muscles and structures of the soft palate and pharynx, including the uvula 1902, levator palatineis 1904, palatine aponeurosis 1906, the superior medial insertion of the palatopharyngeal muscle 1908, and the superior medial insertion of the palatoglossus muscle 1910. These structures are potential targets of neural regulatory signals, and their activation may help maintain airway patency during sleep.

[0276] In some cases, electrodes 1912 and 1924 can be configured to deliver neuromodulation signals to the palatopharyngeal muscle 1916 and the palatoglossal muscle 1920. These muscles play a crucial role in the function of the soft palate and pharynx, and their activation can potentially improve airway function in patients with sleep apnea.

[0277] In other respects, system 1900 can be configured to deliver neuromodulatory signals to the levator veli palatine muscle 1904. This muscle is the main elevating muscle of the soft palate and plays a key role in preventing nasopharyngeal reflux during swallowing. By delivering neuromodulatory signals to this muscle, system 1900 may potentially improve sleep-disordered breathing in patients.

[0278] The arrangement of electrodes 1912 and 1924 allows for targeted stimulation of the palatine and pharyngeal muscles. This configuration is designed to activate the muscles and potentially improve airway function in patients with sleep-disordered breathing. System 1900 may be part of a larger system including a power supply and a controller that can be programmed to direct the delivery of neuromodulatory signals. The delivery of neuromodulatory signals can improve sleep-disordered breathing in patients.

[0279] refer to Figure 20 The illustration shows a neuromodulation therapy system 2000 for treating sleep-disordered breathing. System 2000 includes an electrode array 2004 positioned along the soft palate, extending laterally from the center. The levator veli palatine muscle 2006 is depicted connecting to the palatine aponeurosis 2008 on both sides of the soft palate. The superior medial insertion points of the palatopharyngeal muscle 2010 and the palatoglossal muscle 2012 are indicated at the lateral edges of the soft palate. The electrode array 2014 is positioned near these insertion points.

[0280] In some respects, the electrode array 2004 can be positioned along the soft palate to extend laterally from the center. This configuration allows for the delivery of neuromodulation signals across a wide area of ​​the soft palate, potentially improving sleep-disordered breathing in patients by simultaneously activating multiple muscles.

[0281] The tensor veli palatini muscle 2016 is shown on the side of the soft palate. The palatopharyngeal muscle 2018 and the palatoglossal muscle 2020 are depicted extending downward from the soft palate. Arrows indicating the direction of the neural modulation flow 2022 are shown emanating from electrode arrays 2004 and 2014, indicating the electrical stimulation path through the surrounding tissues.

[0282] The neuromodulation therapy system 2000 can be part of a larger system that includes a power supply and a controller. The power supply can be wired or wirelessly connected to the electrode arrays 2004 and 2014, and the controller can communicate with the electrode arrays 2004 and 2014. The controller can be programmed to direct the delivery of neuromodulation signals through the electrode arrays 2004 and 2014 to a target site, which can be a nerve or muscle. The delivery of neuromodulation signals can improve sleep-disordered breathing in patients.

[0283] refer to Figure 21 The illustration shows a sagittal view of a neuromodulation therapy system 2100 implemented in the oral and pharyngeal regions. System 2100 includes multiple electrodes 2106 and 2116 positioned relative to various muscles and structures of the soft palate and pharynx. Electrodes 2106 and 2116 are configured to deliver neuromodulation signals to specific target sites, as indicated by the direction of the neuromodulation signal 2108.

[0284] In some respects, electrode 2106 can be positioned near the base of the tongue 2104. This arrangement allows for the delivery of neuromodulatory signals to muscles close to the mouth and pharynx, potentially improving sleep-disordered breathing in patients. Electrode 2116 is positioned near the junction of the hard palate 2118 and the soft palate. This arrangement allows for the delivery of neuromodulatory signals to the palatopharyngeal muscles 2112 and the palatoglossal muscles 2110, which are potential targets of neuromodulatory signals. These muscles, along with the uvula 2114, play a crucial role in the function of the soft palate and pharynx, and their activation can potentially improve airway function in patients with sleep-disordered breathing.

[0285] In other cases, system 2100 can be configured to deliver neuromodulatory signals to the levator veli palatine muscle 1904. This muscle is the main elevating muscle of the soft palate and plays a key role in preventing nasopharyngeal reflux during swallowing. By delivering neuromodulatory signals to this muscle, system 2100 can improve sleep-disordered breathing in patients.

[0286] The arrangement of electrodes 2106 and 2116 allows for targeted stimulation of the palatine and pharyngeal muscles. This configuration is designed to activate the muscles and potentially improve airway function in patients with sleep apnea. System 2100 may be part of a larger system including a power supply and a controller that can be programmed to direct the delivery of neuromodulation signals. The delivery of neuromodulation signals can improve sleep apnea in patients.

[0287] refer to Figure 22The diagram illustrates an exploded view of a neuromodulation therapy system 2200. System 2200 includes a retainer 2202, electrodes 2210, an electronic module 2212, and a cover 2214. The retainer 2202 is designed to fit snugly within the patient's oral cavity and can be custom-molded into the patient's dentition for a safe and comfortable fit. The retainer 2202 includes electrode holes 2204, which are positioned to allow electrodes 2210 to contact the patient at specific locations.

[0288] Electrode 2210 is configured to deliver neuromodulation signals to a target site, which may be a nerve or muscle. Electrode 2210 is connected to electronic module 2212, which contains a power supply and a pulse generator. The power supply may be a rechargeable battery, and it may be wirelessly connected to electrode 2210 via wired or wireless communication. The pulse generator is configured to generate neuromodulation signals based on programmed parameters.

[0289] The electronic module 2212 is enclosed within the retainer 2202 and protected by a cover 2214. The cover 2214 is designed to be securely fitted over the electronic module 2212, protecting it from damage and exposure to the oral environment.

[0290] On the surface of electronic module 2212 is a status LED 2206, which serves as an on / off button and indicator. Adjacent to the status LED 2206 is a charging contact 2208 for powering the device. The charging contact 2208 allows energy to be transferred from an external power source to the power source within electronic module 2212.

[0291] In some respects, the neuromodulation therapy system 2200 may be part of a larger system including a charging box and a remote subsystem. The charging box and remote subsystem may be configured to deliver energy to the oral appliance subsystem when the oral appliance subsystem is docked within and / or above and / or near the electromagnetic field of the charging box and remote subsystem. The box and remote subsystem may also function as a programming device for initiating, terminating, modulating, optimizing, and / or regulating therapy delivered by the oral appliance and neurostimulator subsystem via a bidirectional wired or wireless telemetry link.

[0292] In some cases, the neuromodulation therapy system 2200 can be delivered in the form of a retainer, a non-retainer, a stent, a non-implantable form, or an implantable form. The specific form can be selected based on the patient's anatomy, the specific target site for neuromodulation, and other factors. The system 2200 can be designed, manufactured, constructed, constructed, formed, assembled, shaped, molded, fabricated, or produced such that the electrodes 2210 are placed according to the specific patient's anatomy to achieve optimal improvement in airway opening and sleep apnea.

[0293] refer to Figure 23The illustration shows a top view of a neuromodulation therapy system 2300. System 2300 includes a retainer 2304 shaped to fit onto the dental arch. Retainer 2304 includes an electrode array 2306 positioned on its inner surface. Electrode array 2306 consists of a plurality of circular electrodes arranged in a grid pattern. Two batteries 2302 are integrated into retainer 2304, one on each side of electrode array 2306. Batteries 2302 are depicted as circular components embedded within the structure of retainer 2304.

[0294] In some respects, retainer 2304 can be custom-molded to fit the patient's dentition for a safe and comfortable fit. Retainer 2304 can be designed to conform to the shape of the upper teeth and palate, with visible notches to accommodate individual teeth. Retainer 2304 can be made of durable, flexible, and biocompatible materials that are resistant to the oral environment.

[0295] Electrode array 2306 can be configured to deliver neuromodulation signals to specific target sites within the oral cavity and / or nasal cavity, oropharynx and / or nasopharynx. Electrode array 2306 may include multiple electrodes arranged in a specific pattern to optimize the delivery of neuromodulation signals. The electrodes in array 2306 can be independently controlled to deliver neuromodulation signals to specific target sites, thereby allowing targeted stimulation of the palatine and pharyngeal muscles.

[0296] Battery 2302 may be rechargeable and may provide power to electrode array 2306. Battery 2302 may be positioned on both sides of electrode array 2306 to balance the weight of holder 2304 and optimize power distribution to the electrodes.

[0297] In some cases, the neuromodulation therapy system 2300 may be part of a larger system that includes a power supply and a controller. The power supply may be wired or wirelessly connected to the electrode array 2306, and the controller may communicate with the electrode array 2306. The controller may be programmed to direct the delivery of neuromodulation signals through the electrode array 2306 to a target site, which may be a nerve or muscle. The delivery of neuromodulation signals can improve sleep apnea in patients.

[0298] In other respects, the neuromodulation therapy system 2300 can be delivered in the form of a retainer, a non-retainer, a stent, a non-implantable form, or an implantable form. The specific form can be selected based on the patient's anatomy, the specific target sites for neuromodulation, and other factors. The system 2300 can be designed, manufactured, constructed, constructed, formed, assembled, shaped, molded, fabricated, or produced such that the electrode array 2306 is placed according to the specific patient's anatomy to achieve optimal improvement in airway opening and sleep apnea.

[0299] In some aspects, neuromodulation therapy systems 1800, 1900, 2000, 2100, 2200, and 2300 can deliver various types of neuromodulation signals. These signals can be electrical, magnetic, ultrasonic, piezoelectric, radiation, electromagnetic, radio frequency, mechanical, chemical, optical, acoustic, or any combination thereof. The type of neuromodulation signal used can depend on the patient's condition, the target site, and the specific requirements of the desired therapeutic effect.

[0300] In some cases, one or more electrodes of the neuromodulation therapy system 1800, 1900, 2000, 2100, 2200, 2300 can be placed at various locations within the patient's body to deliver neuromodulation signals. One or more electrodes may be placed inside the head and / or neck, at or below or within the mucous membrane, at or below or within the skin and / or skin layer, at or below or within muscles, at or in contact with nerves or nerve fibers, at or within blood vessels, or at or within soft tissues (including tendons and / or ligaments and / or fascia and / or lymph nodes and / or adipose tissue). The specific layout of one or more electrodes may depend on the target sites for neuromodulation and the specific requirements of the patient's condition.

[0301] In other respects, the neuromodulation therapy systems 1800, 1900, 2000, 2100, 2200, and 2300 can deliver neuromodulation signals via various delivery methods. Neuromodulation signals can be delivered via transmucosal / percutaneous and / or transdermal delivery, via needle delivery systems, catheter delivery systems, implantation device delivery systems, sheath delivery systems, dilator delivery systems, guidewire delivery systems, balloon catheter delivery systems, stent delivery systems, microcatheter delivery systems, image-guided delivery systems, endoscopic delivery systems, or optical delivery systems. The specific delivery method used may depend on the target site for neuromodulation, the type of neuromodulation signal used, and the specific requirements of the patient's condition.

[0302] In other cases, the neuromodulation therapy systems 1800, 1900, 2000, 2100, 2200, and 2300 can deliver neuromodulation signals with varying signal parameters. These signal parameters may include current amplitude, voltage amplitude, frequency, pulse width, duty cycle, and pulse configuration. Current amplitude can be delivered in the range of 0.01 mA to 1 A. Voltage amplitude can be delivered in the range of 0.01 V to 250 V. Frequency can be delivered in the range of 0.01 Hz to 10 kHz. Pulse width can be delivered in the range of 0.01 μs to 600 s. Duty cycle can be delivered in the range of 0% to 100%. Pulse configurations can be delivered in any configuration to achieve suitable results, including voltage amplitude ramp, current amplitude ramp, voltage amplitude step, current amplitude step, variable pulse width, variable duty cycle, variable current amplitude, variable voltage amplitude, sine wave configuration, square wave configuration, triangular wave configuration, exponential wave configuration, sawtooth wave configuration, pulse wave configuration, arbitrary wave configuration, in time mode, in time series, in random mode, in random sequence, and / or any combination thereof. The specific signal parameters used can depend on the target site for neuromodulation, the type of neuromodulation signal used, and the specific requirements of the patient's condition.

[0303] In some aspects, neuromodulation therapy systems 1800, 1900, 2000, 2100, 2200, and 2300 can operate in a closed-loop configuration. In this configuration, the system may include one or more sensors for sensing and monitoring various physiological parameters related to sleep and breathing. These parameters may include, but are not limited to, respiratory rate, heart rate, blood oxygen level, and muscle activity. The sensed data can be processed by a processor within the system, which can then control the delivery of neuromodulation signals based on the processed data. For example, the processor can adjust neuromodulation signal parameters, such as current amplitude, voltage amplitude, frequency, pulse width, duty cycle, and pulse configuration, in response to changes in sensed physiological parameters. This closed-loop configuration allows for real-time adjustment of neuromodulation therapy, potentially improving therapeutic efficacy and alleviating sleep-disordered breathing in patients.

[0304] In other cases, the neuromodulation therapy systems 1800, 1900, 2000, 2100, 2200, and 2300 can operate in an open-loop configuration. In this configuration, neuromodulation signal parameters can be pre-configured based on data obtained from polysomnography studies, home sleep studies, or other forms of sleep research or anatomical assessments. For example, neuromodulation signal parameters can be set to target specific nerves or muscles identified based on study or assessment data as causing sleep-disordered breathing in patients. The open-loop configuration allows for personalized treatment of sleep-disordered breathing based on the patient's specific symptoms and needs.

[0305] In some respects, the neuromodulation therapy systems 1800, 1900, 2000, 2100, 2200, and 2300 can be incorporated into or combined with other therapies for treating sleep-disordered breathing. For example, the system can be used in conjunction with continuous positive airway pressure (CPAP) therapy, which provides a constant airflow to keep the patient's airway open during sleep, while the neuromodulation therapy system provides targeted stimulation to specific nerves or muscles to further improve airway patency. In another example, the system can be used in conjunction with a mandibular advancement device that repositions the mandible forward to open the airway, where the neuromodulation therapy system provides additional stimulation to the palatal and pharyngeal muscles to further improve airway patency. In yet another example, the system can be used as an adjunct to surgical interventions for sleep-disordered breathing, thereby providing neuromodulation therapy to enhance the effectiveness of the surgical intervention and potentially improve the patient's sleep-disordered breathing. The combination of the neuromodulation therapy system with other therapies allows for a comprehensive and personalized approach to treating sleep-disordered breathing.

[0306] 4. Computer System

[0307] Figure 24 Example systems that can perform the techniques presented in this paper are described. Figure 24 This is a simplified functional block diagram of a computer that can be configured to perform the techniques described herein, based on exemplary circumstances according to this disclosure. Specifically, the computer (or “platform,” as it may not be a single physical computer infrastructure) may include a data communication interface 2460 for packet data communication. The platform may also include a central processing unit (“CPU”) 2420 in the form of one or more processors for executing program instructions. The platform may include an internal communication bus 2410, and may also include program storage devices and / or data storage devices for various data files to be processed and / or transferred by the platform, such as ROM 2430 and RAM 2440, although system 2400 may receive programming and data via network communication. System 2400 may also include input and output ports 2450 for connection to input and output devices such as a keyboard, mouse, touchscreen, monitor, display, etc. Of course, various system functions may be implemented in a distributed manner on multiple similar platforms to distribute the processing load. Alternatively, the system may be implemented by appropriate programming of a computer hardware platform.

[0308] The general discussion of this disclosure provides a brief, general description of a suitable computing environment in which this disclosure may be implemented. In some cases, any of the disclosed systems, methods, and / or graphical user interfaces may be performed or implemented by a computing system consistent with or similar to the computing systems depicted and / or explained in this disclosure. Although not essential, aspects of this disclosure are described in the context of computer-executable instructions, such as routines executed by data processing devices (e.g., server computers, wireless devices, and / or personal computers). Those skilled in the art will recognize that aspects of this disclosure can be practiced with other communication, data processing, or computer system configurations, including: internet devices, handheld devices (including personal digital assistants (“PDAs”), wearable computers, various cellular or mobile phones (including Voice over IP (“VoIP”) phones), dumb terminals, media players, gaming devices, virtual reality devices, multiprocessor systems, microprocessor-based or programmable consumer electronics, set-top boxes, network PCs, microcomputers, mainframe computers, etc. In practice, the terms “computer,” “server,” etc., are generally used interchangeably herein and refer to any of the foregoing devices and systems as well as any data processor.

[0309] Various aspects of this disclosure may be embodied in a dedicated computer and / or data processor specifically programmed, configured, and / or constructed to perform one or more of the computer-executable instructions explained in detail herein. While aspects of this disclosure (such as certain functions) are described as occurring only on a single device, this disclosure can also be practiced in a distributed environment where functions or modules are shared among different processing devices connected via communication networks such as local area networks (“LANs”), wide area networks (“WANs”), and / or the Internet. Similarly, techniques presented herein that relate to multiple devices may be implemented in a single device. In a distributed computing environment, program modules may reside in local and / or remote memory storage devices.

[0310] The aspects of this disclosure may be stored and / or distributed on a non-transitory computer-readable medium, including magnetically or optically readable computer disks, hardwired or pre-programmed chips (e.g., EEPROM semiconductor chips), nanotechnology memories, biological memories, or other data storage media. Alternatively, computer-implemented instructions, data structures, screen displays, and other data in the aspects of this disclosure may be distributed on the Internet and / or other networks (including wireless networks), distributed for a period of time on propagating signals on a propagation medium (e.g., electromagnetic waves, sound waves, etc.), and / or they may be available on any analog or digital network (packet switching, circuit switching, or other schemes).

[0311] The programmatic aspect of technology can be considered a "product" or "artifact," typically in the form of executable code and / or associated data, carried or embodied in a type of machine-readable medium. "Storage" type media includes any or all tangible memory or associated modules of computers, processors, etc., such as various semiconductor memories, magnetic tape drives, hard disk drives, etc., which provide non-transitory storage for software programming at any time. All or part of the software can sometimes be communicated via the Internet or various other telecommunications networks. For example, such communication enables the loading of software from one computer or processor to another, such as from a management server or host computer of a mobile communication network to a server's computer platform and / or from a server to a mobile device. Therefore, another type of medium that can carry software elements includes light waves, radio waves, and electromagnetic waves, such as physical interfaces between local devices, via wired and fixed leased fiber optic networks, and over various air links. Physical elements carrying such waves, such as wired or wireless links, optical links, etc., can also be considered as media carrying software. As used herein, unless limited to non-transitory tangible "storage" media, terms such as "computer or machine readable medium" refer to any medium that participates in providing instructions to a processor for execution.

[0312] 5. Terminology

[0313] The terms used above may be interpreted in their broadest and most reasonable manner, although they are used in conjunction with the detailed description of certain specific examples of this disclosure. In fact, some terms may even be emphasized above; however, any term intended to be interpreted in any constrained manner will be explicitly and specifically defined in this Detailed Description section. Both the foregoing general description and detailed description are exemplary and explanatory only and do not limit the claimed features.

[0314] As used herein, the terms “comprises / comprising,” “having,” “including,” or other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements may include not only those elements but also other elements not expressly listed or inherent to such process, method, article, or apparatus.

[0315] In this disclosure, relative terms (such as, for example, “about,” “basically,” “whole,” and “approximately”) are used to indicate possible ±10% variations in the stated values.

[0316] The term “exemplary” is used in the sense of “example” rather than “ideal.” As used herein, unless the context otherwise indicates, the singular forms “a,” “an,” and “the” include plural references.

[0317] 6. Examples

[0318] Exemplary embodiments of the systems and methods disclosed herein are described in the numbered paragraphs below.

[0319] A1. A method for maintaining upper airway patency, the method comprising:

[0320] For the patient, at least one electrode is placed to communicate electrically with a target site of the palatine muscle, pharyngeal muscle, and / or the nerve innervating said palatine muscle and / or said pharyngeal muscle; and

[0321] The at least one electrode is activated to deliver an electrical signal to the target site.

[0322] A2. The method according to A1, wherein the target site is selected for one or a combination of the following: tensor veli palatini, levator veli palatini, palatopharyngeus, palatoglossus, uvula, superior retractor and / or middle retractor.

[0323] A3. The method according to any one of A1 to A2, wherein the target site is selected for one or a combination of: (a) a branch of the maxillary branch of the trigeminal nerve innervating the levator palatineis muscle including the lesser palatine nerve, the palatopharyngeal muscle including the lesser palatine nerve, the palatoglossus muscle including the lesser palatine nerve, and the uvula muscle including the lesser palatine nerve; (b) a branch of the mandibular branch of the trigeminal nerve innervating the tensor palatineis muscle, the branch of the mandibular branch including the tensor palatineis nerve; and (c) a branch of the pharyngeal plexus innervating the superior constrictor muscle, the branch of the pharyngeal plexus including pharyngeal plexus branches to the superior constrictor muscle; and / or the nerve of the superior constrictor muscle.

[0324] A4. The method according to A3 further includes delivering the electrical signal to the target site, wherein the target site is selected to target one or a combination of: the tensor veli palatini muscle of the patient, the superior retractor muscle of the patient, and / or the middle retractor muscle of the patient.

[0325] A5. The method according to any one of A1 to A4, wherein the target site is selected for one or a combination of the following: nerves innervating the levator veli palatini, palatopharynx, palatoglossus, uvula, tensor veli palatini, and / or superior constrictor muscles.

[0326] A6. The method according to any one of A1 to A5, wherein activating the at least one electrode to deliver the electrical signal to the target site comprises: stimulating a motor neuron of one or a combination of the following: (a) a maxillary branch of the trigeminal nerve innervating the levator veli palatini, palatoglossus, palatopharynx, and uvula, the maxillary branch including motor neurons of the lesser palatine nerve; (b) a mandibular branch of the trigeminal nerve innervating the tensor veli palatini, the mandibular branch including motor neurons of the tensor veli palatini nerve; and / or (c) a branch of the pharyngeal plexus innervating the superior constrictor muscle, the branch of the pharyngeal plexus including motor neurons of the superior constrictor nerve.

[0327] A7. The method according to any one of A1 to A6, wherein the target site is a muscle that is the palatine muscle and / or the pharyngeal muscle, including one or a combination of the following: tensor veli palatini, levator veli palatini, palatopharyngeal muscle, palatoglossus muscle, uvula muscle, superior retractor muscle and / or middle retractor muscle.

[0328] A8. The method according to any one of A1 to A7, wherein activating the at least one electrode to deliver the electrical signal to the target site of the palatine muscle and / or the pharyngeal muscle comprises stimulating motor fibers to induce partial or complete, or tonic or subtonic, contraction of the palatine muscle and / or the pharyngeal muscle, including contraction of one or a combination of the following: tensor veli palatini, levator veli palatini, palatopharynx, palatoglossus, uvula, superior retractor and / or middle retractor.

[0329] A9. The method according to any one of A1 to A8, wherein the target site is one of a plurality of target sites of a nerve or muscle communicating with one or more palatine muscles and / or pharyngeal muscles, and the plurality of target sites are selected for a group comprising one or more of the following: tensor veli palatini, levator veli palatini, palatopharynx, palatoglossus, uvula, superior retractor and / or middle retractor.

[0330] A10. The method according to any one of A1 to A9 further comprises delivering the electrical signal to the target site of one or a combination of the following: the hypoglossal nerve, the cervical loop nerve, a branch of the pharyngeal plexus to the palatopharyngeal muscle, a branch of the pharyngeal plexus to the palatoglossus muscle, a branch of the pharyngeal plexus to the middle constrictor muscle, a longitudinal tongue muscle, a transverse tongue muscle, a vertical tongue muscle, a genioglossus muscle, a hyoidoglossus muscle, and / or a styloglossus muscle.

[0331] B1. A delivery system placed inside the oral cavity, nasal cavity, oropharynx, and / or nasopharynx, the delivery system comprising:

[0332] At least one electrode is configured to deliver electrical signals to a target site that is a nerve or muscle.

[0333] A power source that communicates wirelessly with at least one electrode; and

[0334] A controller that communicates with the at least one electrode and is programmed to direct the delivery of the electrical signal to the target site via the at least one electrode.

[0335] B2. The delivery system according to B1, wherein the application of the delivery system is for improving upper airway patency.

[0336] B3. The delivery system according to any one of B1 to B2, wherein the electrical signal consists of a series of pulses.

[0337] B4. The delivery system according to any one of B1 to B3, wherein the delivery of the electrical signal comprises: placing at least one electrode to electrically communicate with the target site of the nerve or the muscle via one or a combination of: oral and / or nasal pathways.

[0338] B5. The delivery system according to any one of B1 to B4, wherein the controller and the power supply are enclosed within an oral and / or nasal appliance that communicates wirelessly and / or wiredly with the at least one electrode.

[0339] B6. The delivery system according to any one of B1 to B5, wherein the at least one electrode is a submucosal implanted electrode that communicates wirelessly and / or wiredly with the controller and the power supply.

[0340] B7. The delivery system according to any one of B1 to B6, wherein the at least one electrode is an electrode enclosed within an oral and / or nasal cavity device and positioned for wired and / or wireless communication with the controller and the power source.

[0341] B8. The delivery system according to any one of B1 to B7, wherein delivering the electrical signal to the target site via the at least one electrode is initiated by removing the delivery system from the charging system and / or pressing an activation button with a timer.

[0342] B9. The delivery system according to any one of B1 to B8, wherein the delivery of the electrical signal to the target site via the at least one electrode is initiated by one or a combination of: optical sensing of the device layout, proprioceptive sensing of the device layout, mechanical sensing of the device layout, humidity sensing, chemical sensing, patient physical orientation, body stillness, and / or time of day.

[0343] B10. The delivery system according to any one of B1 to B9, further comprising: a sensor wired and / or wirelessly communicating with the at least one electrode, the sensor being configured to sense physiological and / or anatomical parameters and generate a sensor signal based on the physiological and / or anatomical parameters; and a controller wired and / or wirelessly communicating with the sensor, the controller being programmed to guide the delivery of the electrical signal to the target site through the at least one electrode based on the sensor signal.

[0344] B11. The delivery system according to B10, wherein the physiological and / or anatomical parameters sensed by the sensor are associated with sleep apnea, the physiological and / or anatomical parameters including one or a combination of the following: acoustic vibration, mechanical vibration, airflow parameters, blood flow parameters, heart rate, oxygen saturation, muscle activity and / or neural activity.

[0345] B12. The delivery system according to B10, wherein the sensor is located in or near one or a combination of the following: airway, vascular system, muscle tissue, neural pathway and / or mucosa.

[0346] B13. The delivery system according to B10, wherein the controller includes software configured to analyze the sensor signals.

[0347] Other aspects of this disclosure will be apparent to those skilled in the art upon consideration of the specification and practice of the invention disclosed herein. The specification and examples are intended to be illustrative only, and the true scope and spirit of the invention are indicated by the appended claims.

Claims

1. A method for maintaining upper airway patency, the method comprising: For the patient, at least one electrode is placed to communicate electrically with a target site of the palatine muscle, pharyngeal muscle and / or the nerve that innervates the palatine muscle and / or the pharyngeal muscle; as well as The at least one electrode is activated to deliver an electrical signal to the target site.

2. The method of claim 1, wherein the target site is selected for one or a combination of the following: tensor veli palatini, levator veli palatini, palatopharynx, palatoglossus, uvula, superior retractor and / or middle retractor.

3. The method of claim 1, wherein the target site is selected for one or a combination of: (a) a branch of the maxillary branch of the trigeminal nerve innervating the levator palatine veli muscle including the lesser palatine nerve, the palatopharyngeal muscle including the lesser palatine nerve, the palatoglossus muscle including the lesser palatine nerve, and the uvula muscle including the lesser palatine nerve; (b) a branch of the mandibular branch of the trigeminal nerve innervating the tensor palatine veli muscle, wherein the branch of the mandibular branch includes the tensor palatine veli nerve. and (c) branches of the pharyngeal plexus that innervate the superior constrictor muscle, the branches of the pharyngeal plexus including pharyngeal plexus branches to the superior constrictor muscle; And / or the nerve of the said superior constrictor muscle.

4. The method of claim 3, further comprising delivering the electrical signal to the target site, wherein the target site is selected to target one or a combination of: the tensor veli palatini muscle of the patient, the superior retractor muscle of the patient, and / or the middle retractor muscle of the patient.

5. The method of claim 1, wherein the target site is selected for one or a combination of the following: nerves innervating the levator veli palatini, palatopharynx, palatoglossus, uvula, tensor veli palatini, and / or superior constrictor muscles.

6. The method of claim 1, wherein activating the at least one electrode to deliver the electrical signal to the target site comprises: Stimulate motor neurons of one or a combination of the following: (a) the maxillary branch of the trigeminal nerve innervating the levator veli palatini, palatoglossus, palatopharynx, and uvula, wherein the maxillary branch includes motor neurons of the lesser palatine nerve; (b) the mandibular branch of the trigeminal nerve innervating the tensor veli palatini, wherein the mandibular branch includes motor neurons of the tensor veli palatini nerve; and / or (c) a branch of the pharyngeal plexus innervating the superior constrictor muscle, wherein the branch of the pharyngeal plexus includes motor neurons of the superior constrictor nerve.

7. The method of claim 1, wherein the target site is a muscle that is the palatine muscle and / or the pharyngeal muscle, including one or a combination of the following: tensor veli palatini, levator veli palatini, palatopharynx, palatoglossus, uvula, superior retractor and / or middle retractor.

8. The method of claim 1, wherein activating the at least one electrode to deliver the electrical signal to the target site of the palatine muscle and / or the pharyngeal muscle comprises stimulating motor fibers to induce partial or complete, or tonic or subtonic, contraction of the palatine muscle and / or the pharyngeal muscle, including contraction of one or a combination of the following: tensor veli palatini, levator veli palatini, palatopharynx, palatoglossus, uvula, superior retractor and / or middle retractor.

9. The method of claim 1, wherein the target site is one of a plurality of target sites of a nerve or muscle communicating with one or more palatine muscles and / or pharyngeal muscles, and the plurality of target sites are selected for a group comprising one or more of the following: tensor veli palatini, levator veli palatini, palatopharynx, palatoglossus, uvula, superior retractor and / or middle retractor.

10. The method of claim 1, further comprising delivering the electrical signal to the target site of one or a combination of the following: the hypoglossal nerve, the cervical loop nerve, a branch of the pharyngeal plexus to the palatopharyngeal muscle, a branch of the pharyngeal plexus to the palatoglossus muscle, a branch of the pharyngeal plexus to the middle constrictor muscle, a longitudinal tongue muscle, a transverse tongue muscle, a vertical tongue muscle, a genioglossus muscle, a hyoidoglossus muscle, and / or a styloglossus muscle.

11. A delivery system placed inside the oral cavity, nasal cavity, oropharynx, and / or nasopharynx, the delivery system comprising: At least one electrode is configured to deliver electrical signals to a target site that is a nerve or muscle. A power source that communicates wirelessly with the at least one electrode; as well as A controller that communicates with the at least one electrode and is programmed to direct the delivery of the electrical signal to the target site via the at least one electrode.

12. The delivery system of claim 11, wherein the application of the delivery system is for improving upper airway patency.

13. The delivery system of claim 11, wherein the electrical signal consists of a series of pulses.

14. The delivery system of claim 11, wherein the delivery of the electrical signal comprises placing at least one electrode to electrically communicate with the target site of the nerve or the muscle via one or a combination of: Oral and / or nasal routes.

15. The delivery system of claim 11, wherein the controller and the power supply are enclosed within an oral and / or nasal appliance that communicates wirelessly and / or wiredly with the at least one electrode.

16. The delivery system of claim 11, wherein the at least one electrode is a submucosal implanted electrode that communicates wirelessly and / or wiredly with the controller and the power supply.

17. The delivery system of claim 11, wherein the at least one electrode is an electrode enclosed within an oral and / or nasal cavity device and positioned for wired and / or wireless communication with the controller and the power source.

18. The delivery system of claim 11, wherein delivering the electrical signal to the target site via the at least one electrode is initiated by removing the delivery system from the charging system and / or pressing an activation button with a timer.

19. The delivery system of claim 11, wherein the delivery of the electrical signal to the target site via the at least one electrode is initiated by one or a combination of: optical sensing of the device layout, proprioceptive sensing of the device layout, mechanical sensing of the device layout, humidity sensing, chemical sensing, patient physical orientation, body stillness, and / or time of day.

20. The delivery system according to claim 11, further comprising: A sensor that is wired and / or wirelessly connected to the at least one electrode, the sensor being configured to sense physiological and / or anatomical parameters and generate a sensor signal based on the physiological and / or anatomical parameters; and a controller that is wired and / or wirelessly connected to the sensor, the controller being programmed to guide the delivery of the electrical signal to the target site through the at least one electrode based on the sensor signal.

21. The delivery system of claim 20, wherein the physiological and / or anatomical parameters sensed by the sensor are associated with sleep apnea, the physiological and / or anatomical parameters including one or a combination of: acoustic vibration, mechanical vibration, airflow parameters, blood flow parameters, heart rate, oxygen saturation, muscle activity and / or neural activity.

22. The delivery system of claim 20, wherein the sensor is located in or near one or a combination of: airway, vascular system, muscle tissue, neural pathway and / or mucosa.

23. The delivery system of claim 20, wherein the controller includes software configured to analyze the sensor signals.

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