Patent Description:
In an example, external or implanted muscle stimulation devices or neurostimulation devices can be provided to excite tissue structures in or near an airway, such as to help treat sleep apnea or to counter apneic and hypopneic events.

In an example, neurostimulation can be used to treat a variety of disorders other than OSA. For example, neurostimulation can be used to treat epilepsy, depression, heart failure, obesity, pain, migraine headaches, COPD, or other disorders.

<CIT> describes a system for treating obstructive sleep apnea in a subject. The system can include a power source and a neuromuscular stimulator in electrical communications with the power source. The neuromuscular stimulator can include a controller and at least one electrode. The controller can be configured to receive certain power and stimulation parameters associated with a therapy signal from the power source. The at least one electrode can be configured to deliver the therapy signal to a target tissue associated with control of a posterior base of the tongue of the subject.

The invention is an implantable system as defined in the appended claims.

Neuromodulation of cranial nerves can be used to treat various diseases and disorders, including sleep disorders or breathing disorders. A neuromodulation system can include a housing configured for implantation in an anterior cervical region of a patient, such as at or under a mandible of the patient, such as at least partially in one or more of a submental triangle, a submandibular triangle, and a carotid triangle. The system can include an electrode lead coupled to the housing, and the electrode lead can include an electrode configured to be disposed at or near a cranial nerve target in the patient. The system can be configured to generate electrical neuromodulation signals for delivery to the cranial nerve target using the electrode. In an example, the cranial nerve target can include one or more of a hypoglossal nerve, a glossopharyngeal nerve, a trigeminal nerve, a facial nerve, or a vagus nerve, among others.

Implantable systems for delivery or titration of neuromodulation therapy can optionally include multiple housings, such as can be implanted in different portions of an anterior cervical region of a patient. For example, a first housing including electrostimulation circuitry can be implanted in a submental triangle, a submandibular triangle, or a carotid triangle of the anterior cervical region. A second housing, such as including a battery or other circuitry, can be implanted in a different one of the submental triangle, the submandibular triangle, or the carotid triangle. Implanting different portions of a system in different cervical locations can situate circuitry proximate various neural targets, and can help maintain patient comfort, among other benefits.

This summary is intended to provide an overview of subject matter of the present patent application.

Systems, devices, and methods discussed herein can be configured for electrical stimulation of cranial nerves. Examples discussed herein can include methods for implanting a neuromodulation system or methods for using an implanted system to deliver neuromodulation therapy to one or more target cranial nerves, or to sense physiologic information about a patient, such as to monitor a disease state or control a neuromodulation therapy or other therapy. In an example, system or device features discussed herein can facilitate implantation of devices, leads, sensors, electrostimulation hardware, or other therapeutic means on or near cranial nerve tissue. In an example, the present subject matter includes systems and methods for implanting a neuromodulation device near or below an inferior border of a mandible (i.e., the body or ramus of the mandible or jaw bone) in an anterior triangle of the neck (e.g., located in the medial aspect), or in a posterior triangle of the neck (e.g., located in the lateral aspect), or in multiple regions of the neck.

The present inventors have recognized that a problem to be solved can include providing a minimally invasive neuromodulation therapy or treatment system that can provide signals to neural targets in or near a cervical region of a patient. The problem can include treating, among other things, obstructive sleep apnea (OSA), heart failure, hypertension, epilepsy, depression, post-traumatic stress disorder (PTSD), attention deficit hyperactivity disorder (ADHD), craniofacial pain syndrome, facial palsy, migraine headaches, xerostomia, atrial fibrillation, stroke, autism, inflammatory bowel disease, chronic inflammation, chronic pain, tinnitus, rheumatoid arthritis, or fibromyalgia. The problem can include providing an implantable system that is resistant to migration or dislocation when the system is installed in a motion-prone body region such as in a neck or cervical region of a patient. The problem can further include stimulating multiple different cranial nerve targets concurrently or in a coordinated manner to provide an effective therapy.

The present inventors have recognized, among other things, that a solution to the above-described problems can include a neuromodulation system that can be implanted in an anterior cervical region of a patient, such as at or under a mandible of the patient. In an example, the system can include a housing that can be coupled to tissue in or near an anterior triangle, such as to digastric muscle or tendon tissue, to mylohyoid muscle tissue, to a hyoid bone, or to a mandible, among other locations. The present inventors have recognized that the solution can include a device configured for wireless communication with an external power source or programmer, for example, with a communication device implanted at or near the housing in the anterior cervical region of the patient. The present inventors have recognized that the solution can include an implantable device with multiple electrode leads, such as can extend from a housing in multiple different directions, to interface with multiple different cranial nerves. The present inventors have recognized that the solution can further include or use physiologic information, such as can be sensed from a patient using implanted or external sensors or patient inputs, to update one or more characteristics of a therapy provided to the patient by the neuromodulation system.

The present inventors have recognized that the neuromodulation systems and methods discussed herein can be used to treat OSA, among other disorders or diseases. In an example, an OSA treatment can use a neuromodulation device that is implanted in one or more of a submental triangle and a submandibular triangle, and an electrode lead with electrodes that are configured to be disposed at or near one or more targets on a hypoglossal nerve, vagus nerve, glossopharyngeal nerve, or trigeminal nerve (e.g., at a mandibular branch of the trigeminal nerve). In an example, the solution can include using multiple electrodes or electrode leads to deliver a coordinated, bilateral stimulation therapy to cranial nerve targets, such as to anterior and posterior branches of the hypoglossal nerve. The therapy can be configured to selectively stimulate or block a neural pathway that influences activity of one or more of tongue muscles, mylohyoid muscles, stylohyoid muscles, digastric muscles, or stylopharyngeus muscles of a patient, to thereby treat OSA.

The description that follows describes systems, methods, techniques, instruction sequences, and computing machine program products that illustrate example embodiments of the present subject matter. In the following description, for purposes of explanation, numerous specific examples and aspects are set forth in order to provide an understanding of various embodiments of the present subject matter. It will be evident, however, to those skilled in the art, that embodiments of the present subject matter may be practiced in various combinations. Unless explicitly stated otherwise, structures (e.g., structural components, such as modules or functional blocks) are optional and may be combined or subdivided, and operations (e.g., in a procedure, algorithm, treatment, therapy, or other function) can vary in sequence or can be combined or divided.

In an example, the implantable neuromodulation systems and devices discussed herein can comprise a control system, signal or pulse generator, or other therapy signal generator, such as can be disposed in one or more housings that can be communicatively coupled to share power and/or data. The housings can comprise one or more hermetic enclosures to protect the circuitry or other components therein. In an example, a housing can include one or more headers, such as can comprise a rigid or flexible interface for connecting the housing, or circuitry or components inside of the housing, with leads or other devices or components outside of the housing. In an example, a header can be used to couple signal generator circuitry inside the housing with electrodes or sensors outside of the housing. In an example, the header can be used to couple circuitry inside the housing with a telemetry antenna, wireless power communication devices (e.g., coils configured for near-field communications or NFC), or other devices, such as can be disposed on or comprise flexible substrates or flexible circuits. This system configuration allows the housing(s), lead(s), and flexible circuits to be implanted in different anatomic locations, such as in a neck or cervical region of a patient. In an example, the various system components can be implanted in one or more of the anatomic triangular regions or spaces in the cervical region, and leads or other devices external to a circuitry housing can be tunneled to other locations, including at various cranial nerve targets. Accordingly, various therapeutic elements can be implanted on or
near target cranial nerves, and sensing elements can be implanted on or near the same or other cranial nerves or at other anatomic structures in the same or different locations. Some components can be located in a different anatomic location, such as in a different cervical region than is occupied by a housing. For example, a telemetry antenna or NFC coil can be provided at or near a surface of the skin, while a housing with circuitry that coordinates neuromodulation therapy or power signal management can be implanted elsewhere, such as more deeply within one of the anterior triangle spaces of the neck.

In an example, multiple different housings can comprise a neuromodulation system, and the different housings can contain different control circuitry, power sources, sensors, or other components. The different housings and components therein can be tethered or connected, such as wirelessly or using leads or other flexible circuitry, such as in a serially-connected, daisy-chain configuration or in a star-like configuration. Such system configurations can facilitate implant of one portion of the system in one cervical region, while targeting therapy to a nerve target or sensing physiologic status information or patient activity level or posture from a different region. In an example, a system that is distributed across multiple different areas can help provide flexibility and strain relief from repetitive motion.

The various housings for a cervically-implanted neuromodulation system can have various sizes, shapes, and features. For example, a housing can include surface contours that can correspond, generally, to contours of a triangular (e.g., in one or more dimensions) cervical region in a patient body. For example, some cervical spaces can include one or more three-dimensional regions or pockets, such as can be represented or defined in part by one or more generally triangular or pyramidal spaces, such as can narrow anteriorly and medially. Accordingly, an implantable device housing can have an oblique or truncated prism shape, such as at or along at least one of its faces, to facilitate positioning in such a pocket or space. In an example, the housing can have a generally cylindrical, prismatic, pyramidal, frustum, or spherical configuration, such as can include prismatic variations with or without parallel sides. For example, a housing configured to be implanted in anterior regions of the neck, such as the submandibular triangle or submental triangle, can have a housing shaped as a rectangular prism with wide sides parallel to a base of the mandible to minimize thickness, lessen patient discomfort, and avoid the submandibular gland. In this example, a lead or leads can extend from a header of the housing to one or more cranial nerves, such as the hypoglossal nerve in the submandibular triangle. Other cranial nerves and implantation sites can similarly be used, such as using similarly or differently shaped housings.

The following discussion introduces various anatomic structures, including various triangle regions in a cervical or neck region. Following introduction of the anatomy, the discussion introduces various device s and features thereof that can be configured to provide neuromodulation to cranial nerve targets, among other targets, such as to treat various disorders, diseases, or symptoms.

<FIG> illustrates generally a first anatomic example <NUM> of a front view of an anterior cervical region of a human. The region generally extends between a clavicle <NUM> and mandible <NUM> and can be divided into various additional regions or subregions. In an example, the anterior cervical region includes a pair of anterior triangles on opposite sides of a sagittal midline <NUM>, such as including an anterior triangle <NUM> as illustrated. The term "midline" as used herein refers to a line or plane of bilateral symmetry in the cervical or neck region of a person. In an example, a midline corresponds to the sagittal plane, that is, is the anteroposterior (AP) plane of the body.

The anterior triangle <NUM> can include a region that is bounded by the midline <NUM>, a base of the mandible <NUM>, and a sternocleidomastoid muscle, or SCM <NUM>. A hyoid bone <NUM> can extend between the pair of anterior triangles across the midline <NUM>. The anterior triangle <NUM> can include, among other things, a digastric muscle <NUM> (e.g., including anterior and posterior portions of the digastric muscle <NUM>), a mylohyoid muscle <NUM>, and various other muscle, bone, nerve, and other body tissue.

<FIG> illustrates generally a second anatomic example <NUM> that includes a portion of the anterior triangle <NUM> from the example of <FIG>. <FIG> shows, for example, that the anterior triangle <NUM> can be divided into various regions, including a submandibular triangle <NUM>, and a submental triangle <NUM>. In an example, the anterior triangle <NUM> can further include a carotid triangle, as discussed below in the example of <FIG>. A posterior triangle of the neck (not shown) can be divided into various regions, including an occipital triangle and a supraclavicular triangle.

The submental triangle <NUM> is generally understood to include a region that is bounded by the midline <NUM>, the hyoid bone <NUM>, and the anterior digastric muscle <NUM>. The submandibular triangle <NUM> is generally understood to include a region that is bounded by the anterior digastric muscle <NUM>, the posterior digastric muscle <NUM>, and the base of the mandible <NUM>.

<FIG> illustrates generally a third anatomic example <NUM> that includes a partial side view of the anterior triangle <NUM>. The example of <FIG> further illustrates the location of the submandibular triangle <NUM>, such as in relation to the anterior digastric muscle <NUM> and the mandible <NUM>. The example of <FIG> illustrates the carotid triangle <NUM>, such as can comprise a portion of the anterior triangle <NUM> in the cervical region. The carotid triangle <NUM> is generally understood to include a region that is bounded by the SCM <NUM>, the omohyoid muscle <NUM>, and the posterior digastric muscle <NUM>.

In an example, an implantable neuromodulation device can be implanted in the anterior triangle <NUM> or in the posterior triangle, such as using the systems and methods discussed herein. In further examples, an implantable neuromodulation device can be implanted in one or more of the submental triangle <NUM> and the submandibular triangle <NUM>. The implantable neuromodulation device can be configured to provide a stimulation therapy to one or multiple nerve targets such as can be in or near the anterior triangle <NUM> or the posterior triangle, or to nerve targets that can be accessed via tunneled leads that extend from a housing disposed in the anterior triangle <NUM> or the posterior triangle. In other words, various regions in the anterior and posterior cervical triangles can provide access to a main body of, or to branches of, various cranial nerves, including the hypoglossal nerve (CN XII), the accessory nerve (CN XI), the vagus nerve (CN X), the glossopharyngeal nerve (CN IX), the facial nerve (CN VII), and the trigeminal nerve (CN V), among others.

The present inventors have realized that the anterior and posterior cervical triangles are anatomic locations suitable for implantation of a neuromodulation system or component thereof. The present inventors have further realized that the locations include various anatomic structures suitable for coupling and therefore stabilizing a neuromodulation system or component thereof. For example, the present inventors have recognized that such coupling structures can include the hyoid bone <NUM>, the connective tissue sling of the hyoid bone <NUM>, the mandible <NUM>, the digastric tendon, the anterior or posterior portion of the digastric muscle <NUM>, the stylohyoid muscle <NUM>, the mylohyoid muscle <NUM>, the omohyoid muscle, or the SCM <NUM>.

<FIG> illustrates generally a fourth anatomic example <NUM> that includes a partial side view that includes the anterior triangle <NUM>. The fourth anatomic example <NUM> illustrates an upper portion of the anterior triangle <NUM> and a portion of the upper neck, such as at or below a temporal bone <NUM>. A representation of a tongue <NUM> and of a portion of a jugular vein <NUM> is included for further context and reference.

The fourth anatomic example <NUM> shows various nerves and vessels. The illustrated nerves include some, but not all, of the cranial nerves that can be targeted using the neuromodulation systems, devices, and methods discussed herein. For example, nerve targets in the fourth anatomic example <NUM> include a facial nerve <NUM>, a jugular vein <NUM>, a glossopharyngeal nerve <NUM>, a pharyngeal branch of vagus nerve <NUM>, a vagus nerve <NUM>, a hypoglossal nerve <NUM>, and a mandibular branch of the trigeminal nerve <NUM>, among others.

The example of <FIG> includes an example of an implantable therapy device <NUM>. The implantable therapy device <NUM> can be implanted in a patient in an upper portion of an anterior triangle <NUM> of a cervical region of the patient. For example, the implantable therapy device <NUM> can be implanted in one or more of the submental triangle <NUM> and the submandibular triangle <NUM>. In the example of <FIG>, the implantable therapy device <NUM> can be coupled to various anatomical structures, such as a stylohyoid muscle <NUM>, a hyoid bone <NUM>, or other tendons or structures in the upper neck.

The example of <FIG> includes multiple leads coupled to the implantable therapy device <NUM>. For example, the implantable therapy device <NUM> can be coupled to a lower electrode lead <NUM>, an anterior electrode lead <NUM>, and an upper electrode lead <NUM>. The lower electrode lead <NUM> can be implanted at or near a neural target on the vagus nerve <NUM>, for example, in or adjacent to the carotid triangle <NUM>. In an example, the lower electrode lead <NUM> can be coupled to the SCM <NUM> or other structure at or near the vagus nerve <NUM>. The upper electrode lead <NUM> can be implanted at or near the facial nerve <NUM>, the mandibular branch of the trigeminal nerve <NUM>, or the glossopharyngeal nerve <NUM>, among others. In an example, the anterior electrode lead <NUM> can be implanted at or near a neural target on the hypoglossal nerve <NUM>. Various details of the implantable therapy device <NUM> and its associated leads are discussed herein, including in the example of <FIG>.

In an example, the various implantable devices and components thereof that are discussed herein can be coupled to various anatomic structures or tissues inside a patient body, such to stabilize or maintain a device or component at a particular location and resist device movement or migration as the patient carries out their daily activities. In an example, coupling a device or component to tissue can include anchoring, affixing, attaching, or otherwise securing the device or component to tissue using a coupling feature. A coupling feature can include, but is not limited to, a flap or flange, such as for suturing to tissue (e.g., muscle, tendon, cartilage, bone, or other tissue).

In an example, a coupling feature can include various hardware such as a screw or helical member that can be driven into or attached to tissue or bone. In an example, a coupling feature can include a cuff, sleeve, adhesive, or other component. In an example, one or multiple different coupling features can be used for different portions of the same neuromodulation system. For example, a suture can be used to couple a device housing to a tissue site, and a lead, such as coupled to the housing, can include a distal cuff to secure the lead at or near a neural target.

<FIG> illustrates generally an example of a system <NUM> that can be configured to provide or control a neuromodulation therapy. The system <NUM> can include an implantable system <NUM> and an external system <NUM>. The implantable system <NUM> and the external system <NUM> can be communicatively coupled using a wireless coupling <NUM>. In an example, the wireless coupling <NUM> can enable power signal communication (e.g., unidirectionally from the external system <NUM> to the implantable system <NUM>), or can enable data signal communication (e.g., bidirectionally between the implantable system <NUM> and the external system <NUM>). In an example, the implantable system <NUM> or the external system <NUM> can be wirelessly coupled for power or data communications with one or more other devices, including other implantable or implanted devices, such as in the same patient body.

In the example of <FIG>, the implantable system <NUM> can include an antenna <NUM>, a sensor(s) <NUM> such as comprising one or more physiologic sensors, a stimulation lead(s) <NUM>, a processor circuit <NUM>, an ultrasonic transducer <NUM>, a power storage circuit <NUM>, a stimulation signal generator circuit <NUM>, and a memory circuit <NUM>, among other components or modules.

In an example, the antenna <NUM> can include a telemetry antenna such as configured for data communication between the implantable system <NUM> and the external system <NUM>. In an example, the antenna <NUM> can include an antenna, such as an NFC coil, that is configured for wireless power communication between the implantable system <NUM> and the external system <NUM> or other external power source.

The processor circuit <NUM> can include a general purpose or purpose-built processor. The memory circuit <NUM> can include a long-term or short-term memory circuit, such as can include instructions executable by the processor circuit <NUM> to carry out therapy or physiologic monitoring activities for the system <NUM>. In an example, the processor circuit <NUM> of the implantable system <NUM> is configured to manage telemetry or data signal communications with the external system <NUM>, such as using the antenna <NUM> or other communication circuitry.

In an example, the stimulation signal generator circuit <NUM> includes an oscillator, pulse generator, or other circuitry configured to generate electrical signals that can provide electrostimulation signals to a patient body, or to power various sensors (e.g., including the sensor(s) <NUM>), or transducers (e.g., including the ultrasonic transducer <NUM>). In an example, the stimulation signal generator circuit <NUM> can be configured to generate multiple electrical signals to provide multipolar electrostimulation therapy to multiple neural targets, such as concurrently or in a time-multiplexed manner. The stimulation signal generator circuit <NUM> can be configured to use or provide different neurostimulation signals, such as can have different pulse amplitude, pulse duration, waveform, stimulation frequency, or burst pattern characteristics.

The stimulation signal generator circuit <NUM> can be used to generate therapy signals for multiple different targets concurrently. For example, signals from the stimulation signal generator circuit <NUM> can be used to stimulate one cranial nerve target to efferent effect, and to stimulate a different nerve or branch to elicit an afferent response. In another example, one cranial nerve can be blocked while another nerve is stimulated. Other combinations can similarly be used.

In an example, the stimulation lead(s) <NUM> can include one or more leads that are coupled to or integrated with a housing or header of the implantable system <NUM>. The stimulation lead(s) <NUM> can be detachable from the housing to facilitate replacement or repair.

In an example, the stimulation lead(s) <NUM> can include electrostimulation hardware such as electrodes having various configurations, including cuff electrodes, flat electrodes, percutaneous electrodes or other configurations suitable for electrical stimulation of nerves or nerve bodies or branches. In an example, the stimulation lead(s) <NUM> can additionally or alternatively comprise other neuromodulation therapy hardware such as the ultrasonic transducer <NUM>, drug delivery means, or a mechanical actuator, such as can be configured to modulate neural activity.

The leads and/or electrodes discussed herein can have various features that can facilitate placement at, and stimulation of, one or more neural targets. A lead can have one or more electrodes that can be used for nerve stimulation, nerve blocking, or nerve sensing. The electrodes can have various surface area and spacing (e.g., spacing from other electrodes, sensors, targets, etc.) to optimize for a particular function. In an example, an electrode can comprise various materials, including low-oxidation metals or metal alloys (e.g., platinum, platinum iridium, etc.) for use in implantable systems. In an example, an electrode can be treated or coated with another material such as to promote healing or enhance charge transfer to tissue.

In an example, an electrode lead can comprise one or multiple electrodes, such as can having the same or different electrode characteristics. A lead can include, for example, a spiral electrode or cuff electrode. In such an example, one or more conductive surfaces can be exposed on an inside surface of a curved or spiral cuff assembly such as can comprise a portion of a lead body. In an example, a spiral cuff assembly (and hence, electrodes) can be designed to circumferentially wrap snugly around a body of a nerve and can be self-sizing. In an example, a cuff electrode can be configured to surround a particular target to thereby direct stimulation energy to the target from multiple different directions concurrently, such as while insulating the electrode from adjacent tissue.

In an example, a surface electrode or electrode array can be used. In this example, one or more electrodes can be exposed on one side of a flat or round section of a lead body. An array of electrodes of various shapes, sizes, or other characteristics, can be provided to spatially control neuromodulation therapy delivery. In an example, electrode surfaces can be oriented toward a target nerve or other structure, such as to focus an electric field provided by the electrode or electrodes. Surface electrode leads can be surgically placed by exposing the target anatomy, or can be steered using, e.g., a catheter-based delivery system from a distal surgical access point.

In an example, a percutaneous electrode can be used, such as including one or more electrodes exposed on a lead that is inserted into a blood vessel (or other conducting tissue in the vicinity of a neural target) using percutaneous techniques. A percutaneous lead can be navigated by a clinician, within or through vasculature, toward target nerves or neural structures that are in close proximity to the vasculature. In an example, electrodes on a percutaneous lead can be directly on the lead body or can comprise a percutaneous structure, such as a stent-like frame or scaffold, whereby the electrodes can be oriented towards the target and away from the blood in the vessel.

In an example, a bifurcated lead can be used to provide electrodes at multiple different and spaced apart anatomical targets while using a single connection to a header. In an example, a modular lead can be used such as to extend or tailor a lead to accommodate a patient's anatomy or target structures.

In an example, the stimulation lead(s) <NUM> can comprise one or more electrodes that can be provided or grouped together at a distal end of a lead, such as spaced apart from a housing, or the electrodes can be distributed along a length of the lead. In an example, a lead can include multiple different electrode groups of one or more electrodes provided at different locations along a length of the lead. Additionally, a housing of the various devices discussed herein can include one or more electrodes configured for use in electrostimulation delivery. Each of the electrodes in or coupled to the implantable system <NUM> can be separately addressable by neuromodulation therapy control or coordination circuitry to deliver a coordinated therapy to one or multiple targets.

Various stimulation configurations can be used with any of the electrode or lead types discussed herein. In an example, different configurations can be used to provide or modify a stimulating electric field to thereby affect an extent and manner of neural excitation. The configurations can include, for example, unipolar, bipolar, and various combinations of multipolar configurations. In a bipolar or multipolar configuration, a guard electrode can be used to help steer excitation or inhibit neural activity. In an example, an electrode configuration can be dynamically changed, such as throughout the course of a particular therapy, such as through programming changes or during operation to achieve a particular therapy.

In an example, the sensor(s) <NUM> can include, among other things, electrodes for sensing of electrical activity such as using electrocardiograms (ECGs), impedance, electromyograms (EMGs) of select muscles, and/or electroneurograms (ENGs) of target cranial nerves and branches. The sensor(s) <NUM> can include pressure sensors, photoplethysmography (PPG) sensors, chemical sensors (e.g., pH, lactate, glucose, etc.) or other sensors that can be used for physiologic sensing of cardiac, respiratory, or other physiologic activity. In an example, the sensor(s) <NUM> can include an accelerometer, gyroscope or geomagnetic sensor, such as can be configured to measure patient or device movement, vibration, position, or orientation information. Other examples of the sensor(s) <NUM> are discussed elsewhere herein, including in the discussion of the machine <NUM> and the various I/O components <NUM>, such as including the biometric components <NUM>, motion components <NUM>, and environmental components <NUM>. In an example, information from the sensor(s) <NUM> can be received by the processor circuit <NUM> and used to update or titrate a neuromodulation therapy.

In an example, the implantable system <NUM> can include one or more sensor(s) <NUM>, such as can be used in providing closed-loop neuromodulation therapy that is based at least in part on physiologic status information about a patient (e.g., respiration, heart rate, blood pressure, neural or muscular activation, or other information). In an example, the sensor(s) <NUM> can be used to receive diagnostic information, or to receive information about patient movement or body position.

In an example, hypoglossal nerve stimulation, such as to treat OSA, can be controlled at least in part based on information from an accelerometer or gyroscope to determine patient respiration, patient activity, and body orientation or position, such as together with information from a pressure sensor about respiration. In other words, using information from the sensor(s) <NUM>, such as including accelerometer and pressure sensors, the implantable system <NUM> can control neuromodulation therapy provided to the hypoglossal nerve, such as can include stimulation during a particular time within a respiratory cycle, and can use body position information to automatically enable therapy when, for example, the patient is sleeping.

In the example of <FIG>, the external system <NUM> can include various components that can be provided together as a unitary external device or can include multiple devices configured to work together to manage a patient therapy, manage a device such as the implantable system <NUM>, or perform other functions associated with the implantable system <NUM>. The external system <NUM> can include an antenna <NUM>, a processor circuit <NUM>, and an interface <NUM>, among other components or modules.

The antenna <NUM> can comprise one or multiple antennas such as can be configured for nearfield or farfield communications with, for example, the antenna <NUM> of the implantable system <NUM>, a different implantable device or system, or other external device. In an example, the antenna <NUM> and the antenna <NUM> can be used to exchange power or data between the implantable system <NUM> and the external system <NUM>. For example, information about a prescribed therapy can be uploaded from the external system <NUM> to the implantable system <NUM>, or information about a physiologic status, such as measured by the sensor(s) <NUM>, can be downloaded from the implantable system <NUM> to the external system <NUM>.

The processor circuit <NUM> can include a general purpose or purpose-built processor configured to carry out various activities on the external system <NUM> or in coordination with the implantable system <NUM>. In an example, the processor circuit <NUM> of the external system <NUM> is configured to manage telemetry or data signal communications with the implantable system <NUM>, such as using the antenna <NUM> or other communication circuitry.

The interface <NUM> can include a patient or clinician interface, such as to report device information or to receive instructions or therapy parameters for implementation by the implantable system <NUM>. In an example, the interface <NUM> can include an interface or gateway to facilitate communication between the <NUM> or the external system <NUM> with a patient management system or other medical record system. Other features, modules, and components of the implantable system <NUM> and the external system <NUM> can be included in the system <NUM> to help administer various neuromodulation therapies.

In an example, the systems, devices, and components discussed herein, including at least the implantable system <NUM> and the external system <NUM> of the system <NUM>, can be used to provide neuromodulation therapy to nerve targets inside a patient body, such as to treat one or more disorders or diseases. In an example, the system <NUM> or components thereof can be configured to provide neuromodulation therapy to multiple nerve targets in a coordinated manner, such as concurrently, or in a time-multiplexed sequence. In an example, the neuromodulation therapy can include one or more, or combinations of, neural stimulation and blocking signals, such as can be directed to afferent or efferent nerve structures or targets to trigger different responses. The therapy can optionally include using vector-based stimulation configurations to target particular nerves or nerve regions, or can include more relatively targeted or isolated nerve fibers. In an example, a coordinated neuromodulation therapy can include blocking at a first nerve target, while stimulating a second nerve target, or concurrently (or in time-sequence) stimulating multiple different nerve targets.

In an example, the particular patient disorder or disease can dictate the particular neural target to modulate with a neuromodulation therapy. For example, to treat obstructive sleep apnea using the system <NUM>, various cranial nerves can be targeted individually or together, such as including the trigeminal nerve (e.g., the V3 mandibular branch of the trigeminal nerve <NUM>), the hypoglossal nerve <NUM> (e.g., including one or more branches thereof), the glossopharyngeal nerve <NUM>, the vagus nerve <NUM>, or the facial nerve <NUM> (e.g., including various extracranial branches thereof).

In an example, the system <NUM> can be used to treat OSA by providing a neuromodulation therapy to or including the mandibular branch of the trigeminal nerve <NUM> and the hypoglossal nerve <NUM>. In this example, neuromodulation of the mandibular branch of the trigeminal nerve <NUM> can influence motor control of the mylohyoid muscle <NUM> or the anterior digastric muscle <NUM>, and neuromodulation of the hypoglossal nerve <NUM> can influence motor control of muscles in the tongue <NUM>.

In an example, the system <NUM> can be used to treat OSA by providing a neuromodulation therapy to or including the facial nerve <NUM> and to the hypoglossal nerve <NUM>. In this example, neuromodulation of the facial nerve <NUM> can influence motor control of the stylohyoid muscle <NUM> or the posterior digastric muscle <NUM>, and neuromodulation of the hypoglossal nerve <NUM> can influence motor control of muscles in the tongue <NUM>.

In an example, the system <NUM> can be used to treat OSA by providing a neuromodulation therapy to or including the glossopharyngeal nerve <NUM> and the hypoglossal nerve <NUM>. In this example, neuromodulation of the glossopharyngeal nerve <NUM> can influence motor control of the stylopharyngeus muscle, and neuromodulation of the hypoglossal nerve <NUM> can influence motor control of muscles in the tongue <NUM>.

In an example, the system <NUM> can be used to treat OSA by providing a neuromodulation therapy to or including various branches of the hypoglossal nerve <NUM>, including anterior branches, posterior branches, or multiple branches concurrently, including or using a bilateral configuration to target branches on opposite sides of the midline <NUM> of a patient. The neuromodulation of the hypoglossal nerve <NUM> can influence motor control of various muscles in the tongue <NUM>. In an example, neuromodulation therapy that includes stimulating or blocking the hypoglossal nerve <NUM> can be combined with therapy that targets one or more of the mandibular branch of the trigeminal nerve <NUM> (e.g., to influence motor control of the mylohyoid muscle <NUM> or the anterior digastric muscle <NUM>), the facial nerve <NUM> (e.g., to influence motor control of the stylohyoid muscle <NUM> or the posterior digastric muscle <NUM>), or the glossopharyngeal nerve <NUM> (e.g., to influence motor control of the stylopharyngeus muscle), among others.

Any one or more branches of the hypoglossal nerve <NUM> can receive a neuromodulation therapy from the implantable system <NUM>. For example, any one or more of the posterior branches of the hypoglossal nerve <NUM> can receive neuromodulation, including for example "branches" off the hypoglossal nerve sheath such as the descending branch, also referred to as the superior root of the ansa cervacalis, the thyrohyoid branch, or the geniohyoid branch. Any one or more of the anterior branches of the hypoglossal nerve <NUM> can receive neuromodulation, including for example where a main trunk of the hypoglossal nerve <NUM> branches to the muscles of the tongue, also referred to as the muscular branch (B6), or including the muscular branch itself. The muscular branch can include sub-branches or nerve fibers that innervate specific muscles of the tongue.

In an example, the system <NUM> can be used to treat OSA or other disorders or diseases such as heart failure, hypertension, atrial fibrillation, epilepsy, depression, stroke, autism, inflammatory bowel disease, chronic inflammation, chronic pain (e.g., in cervical regions, in the lower back, or elsewhere), tinnitus, or rheumatoid arthritis, among others, such as by providing a neuromodulation therapy to or including the vagus nerve <NUM>. Neuromodulation of the vagus nerve <NUM> can influence parasympathetic tone to thereby treat or alleviate symptoms associated with the various diseases or disorders mentioned, among others. In an example, a therapy that includes stimulation of the vagus nerve <NUM> can include therapy provided to one or more branches of the hypoglossal nerve <NUM>, the mandibular branch of the trigeminal nerve <NUM>, the facial nerve <NUM>, or the glossopharyngeal nerve <NUM>. In an example, neuromodulation therapy that includes stimulating or blocking a portion of the vagus nerve <NUM> can be combined with therapy that targets one or more of the glossopharyngeal nerve <NUM> (e.g., to further influence parasympathetic tone), the carotid sinus (e.g., to stimulate a baroreceptor response), or the superior cervical ganglion or branches thereof (e.g., to influence sympathetic tone).

In an example, a neuromodulation therapy for treatment of heart failure, hypertension, and/or atrial fibrillation can include therapy provided to or including one or more of the glossopharyngeal nerve <NUM> (e.g., to influence parasympathetic tone, such as via communication to the vagus nerve <NUM>), the superior cervical ganglion (e.g., to influence sympathetic tone), or the carotid sinus (e.g., to stimulate a baroreceptor response).

In an example, the system <NUM> can be configured to treat heart failure, hypertension, migraine headaches, xerostomia, or other diseases or disorders by providing a neuromodulation therapy to or including the glossopharyngeal nerve <NUM>. Stimulation or blocking of the glossopharyngeal nerve <NUM> can, for example, influence parasympathetic tone or can affect motor activity of the stylopharyngeus muscle.

In an example, the system <NUM> can be configured to treat drug-refractory epilepsy, depression, post-traumatic stress disorder (PTSD), migraine headaches, attention-deficit hyperactivity disorder (ADHD), craniofacial pain syndrome, among other diseases and disorders, such as by providing a neuromodulation therapy to or including the mandibular branch of the trigeminal nerve <NUM>.

In an example, the system <NUM> can be configured to treat craniofacial pain syndrome, or facial palsy, among other things, such as by providing a neuromodulation therapy to or including the facial nerve <NUM>, such as including various extracranial branches or roots thereof. In an example, the system <NUM> can be configured to treat fibromyalgia such as by providing a neuromodulation therapy to or including the spinal accessory nerve, such as to target the trapezius muscle, which is understood to be a potential trigger point for fibromyalgia. In an example, the system <NUM> can be configured to treat migraine headaches or tinnitus, such as by providing a neuromodulation therapy to or including a great occipital nerve, such as can be accessed using electrodes implanted in the cervical region of a patient.

Neuromodulation therapies can thus be provided using the system <NUM>, or using components thereof, to treat a variety of different diseases or disorders. The therapies can include targeted, single-location stimulation or blocking (e.g., using electrical pulses, ultrasonic signals, or other energy) therapy at one of the locations mentioned herein (among others) or can include coordinated stimulation or blocking across or using multiple different locations. The following discussion illustrates several examples of different implantation locations and neural targets, however, others including those specifically mentioned above, can similarly be used.

In an example, the implantable system <NUM> can comprise various devices that can be implanted in various different areas of the body, including in a cervical region. The examples of <FIG>, and <FIG> through <FIG>, illustrate generally different examples of the implantable system <NUM> such as implanted in various different cervical locations.

<FIG> illustrates generally a first example <NUM> that includes a first implantable device <NUM> implanted in the submandibular triangle <NUM> of a patient. In the first example <NUM>, the first implantable device <NUM> can be coupled to an anatomic structure in the submandibular triangle <NUM>, such as using a suture, anchor, or other affixation means. In an example, the first implantable device <NUM> can be coupled to one or more of the mandible <NUM>, the anterior digastric muscle <NUM>, the posterior digastric muscle <NUM>, the mylohyoid muscle <NUM>, the digastric tendon <NUM>, or other bone, tendon, muscle, or other structure that is in or adjacent to the submandibular triangle <NUM>. In the example of <FIG>, the first implantable device <NUM> can be provided near, but spaced apart from, a submandibular gland <NUM> of the patient.

In the example of <FIG>, the first implantable device <NUM> includes a first header <NUM>. The first header <NUM> can be used to couple one or multiple electrode leads, sensor leads, or other devices to the first implantable device <NUM>. For example, the first header <NUM> can be used to couple the first implantable device <NUM> to a first electrode lead <NUM>, and the first electrode lead <NUM> can be tunneled to a cranial nerve target. Electrodes configured to deliver electrostimulation signals to the nerve target can be situated at or adjacent to the target. In an example, the first electrode lead <NUM> can be tunneled to a hypoglossal nerve in or near an anterior cervical region of a patient.

In the example of <FIG>, the first implantable device <NUM> is shown with one header. The first implantable device <NUM> can optionally include multiple headers to interface the first implantable device <NUM> with one or multiple other leads, such as electrode leads, sensor leads, communication coils, or other devices. Referring again to <FIG>, for example, the implantable therapy device <NUM> can include multiple headers, such as coupled to the respective different leads that extend from opposite sides of a body of the implantable therapy device <NUM>.

<FIG> illustrates generally a second example <NUM> that includes a second implantable device <NUM> implanted in the submandibular triangle <NUM> of a patient. In the second example <NUM>, the second implantable device <NUM> can be coupled to an anatomic structure in the submandibular triangle <NUM>, such as using a suture, anchor, or other affixation means. In an example, the second implantable device <NUM> can be coupled to one or more of the mandible <NUM>, the anterior digastric muscle <NUM>, the posterior digastric muscle <NUM>, the mylohyoid muscle <NUM>, or other bone, tendon, muscle, or other structure that is in or adjacent to the submandibular triangle <NUM>.

The example of the second implantable device <NUM> includes an elongate housing structure with respective headers on opposite side ends of the device. For example, the second implantable device <NUM> includes a first header <NUM> coupled to the first electrode lead <NUM>, such as can be tunneled to a first cranial nerve target. The second implantable device <NUM> can include a second header <NUM> coupled to a second electrode lead <NUM> and to a first data and power communication lead <NUM>. The second electrode lead <NUM> can be coupled to a second cranial nerve target.

In an example, the first data and power communication lead <NUM> can couple the second implantable device <NUM> to a wireless communication coil <NUM>. The wireless communication coil <NUM> can be configured to facilitate data or power signal communication with a wireless external device, such as external to the patient. In an example, the wireless communication coil <NUM> comprises the antenna <NUM> that can be used to communicate with the external system <NUM>. Power or data signals received using the wireless communication coil <NUM> can be communicated to the second implantable device <NUM> and stored or used.

In the example of <FIG>, the wireless communication coil <NUM> can be coupled or mounted to a first coil support <NUM>. The first coil support <NUM> and the wireless communication coil <NUM> can comprise a flexible structure that can be positioned at or near a tissue interface of a patient, such as under the skin and adjacent to muscle, bone, or other tissue. For example, the first coil support <NUM> can be provided at or adjacent to a surface of the anterior digastric muscle <NUM> and facing away from the patient body. In another example, the first coil support <NUM> can be provided interiorly to the anterior digastric muscle <NUM>, or behind the anterior digastric muscle <NUM> in the view of <FIG>. The first coil support <NUM> can be otherwise oriented elsewhere in the anterior triangle <NUM> of the patient and can be coupled to the second implantable device <NUM> by tunneling the first data and power communication lead <NUM>. For example, the first coil support <NUM> can be provided under a chin region, such as at or near a tip of the submental triangle <NUM> of the patient, away from the hyoid bone <NUM>.

<FIG> illustrates generally a third example <NUM> that includes a submental implantable device <NUM> implanted in the submental triangle <NUM> of a patient. In the third example <NUM>, the submental implantable device <NUM> can be coupled to an anatomic structure in the submental triangle <NUM>, such as using a suture, anchor, or other affixation means. In an example, the submental implantable device <NUM> can be coupled to one or more of the mylohyoid muscle <NUM>, the anterior digastric muscle <NUM>, the hyoid bone <NUM>, or other bone, tendon, muscle, or other structure that is in or adjacent to the submental triangle <NUM>. The submental implantable device <NUM> can be installed adjacent to, or at least partially under the anterior digastric muscle <NUM>, such as between the anterior digastric muscle <NUM> and the underlying mylohyoid muscle <NUM>.

The example of the submental implantable device <NUM> includes an elongate housing structure with at least one header on a first side end of the device. In the example of <FIG>, the submental implantable device <NUM> is coupled to an electrode lead <NUM> that can be tunneled to a first cranial nerve target. The submental implantable device <NUM> can be coupled to a submandibular communication coil <NUM>, such as using a second data and power communication lead <NUM>.

In the example of <FIG>, the submandibular communication coil <NUM> can be coupled or mounted to a second coil support <NUM>. The second coil support <NUM> and the submandibular communication coil <NUM> can comprise a flexible structure that can be positioned at or near a tissue interface of a patient, such as under the skin and adjacent to muscle, bone, or other tissue. For example, the second coil support <NUM> can be provided at or adjacent to a surface of at least one of the posterior digastric muscle <NUM> and the anterior digastric muscle <NUM>, and can be oriented such that the submandibular communication coil <NUM> faces away from the patient body. In another example, the first coil support <NUM> can be provided interiorly to the digastric muscles, such as adjacent to the mylohyoid muscle <NUM>.

<FIG> illustrates generally a fourth example <NUM> that includes a third implantable device <NUM> implanted in the carotid triangle <NUM> of a patient. In the fourth example <NUM>, the third implantable device <NUM> can be coupled to an anatomic structure in the carotid triangle <NUM>, such as using a suture, anchor, or other affixation means. In an example, the third implantable device <NUM> can be coupled to one or more of the SCM <NUM>, the omohyoid muscle <NUM>, the hyoid bone <NUM>, or other bone, tendon, muscle, or other structure that is in or adjacent to the carotid triangle <NUM>.

The example of the third implantable device <NUM> includes an elongate housing structure with at least one header on a first side end of the device. In the example of <FIG>, the third implantable device <NUM> is coupled to a multipolar electrode lead <NUM> that can be tunneled to a cranial nerve target. For example, an electrode array <NUM> of the multipolar electrode lead <NUM> can be disposed at or near a nerve target (or targets) outside of the carotid triangle <NUM>, and the multipolar electrode lead <NUM> can be tunneled to the carotid triangle <NUM> to couple with the third implantable device <NUM>. In an example, the electrode array <NUM> can be provided at or near a hypoglossal nerve <NUM> of the patient, such as in or near the submandibular triangle <NUM>.

<FIG> illustrates generally an example of a first segmented device <NUM>. The first segmented device <NUM> can be an implantable device that is configured for implantation at or in an anterior cervical region of a patient. For example, the first segmented device <NUM> can be configured to be implanted in one or multiple different triangles of the cervical region, as further described below. That is, different segments or portions of the first segmented device <NUM> can be implanted in respective different triangles in a cervical region of a patient. In an example, the first segmented device <NUM> comprises the implantable system <NUM> from the example of <FIG>.

The first segmented device <NUM> includes a first housing <NUM> and a second housing <NUM> that can be connected using a flexible housing coupling <NUM>. The first segmented device <NUM> can include a first cuff electrode <NUM> (e.g., comprising one or multiple electrodes) that is coupled to the first housing <NUM> using an electrode lead <NUM>. The first segmented device <NUM> can further include a communication coil <NUM>, such as can be electrically coupled to the second housing <NUM> using a power and data lead <NUM>.

The communication coil <NUM> can be coupled to a support member <NUM> that can help maintain the coil in a configuration suitable for wireless communications with an external transmitter. In an example, the support member <NUM> can include one or more mounting features <NUM> to couple the support member <NUM>, and therefore the communication coil <NUM>, to an anatomical structure inside a patient body. For example, the mounting feature <NUM> can include one or more through-holes in the support member <NUM> that can be used to suture the support member <NUM> to a tissue site. In an example, the support member <NUM> can comprise a flexible, irregularly shaped flap configured for implantation and avoidance of particular structures, such as a submandibular gland or nerve to the mylohyoid. The flap can help couple the support member <NUM> superiorly.

In an example, the second housing <NUM> comprises a power storage circuit, such as can comprise the power storage circuit <NUM> from the example of <FIG>. The power storage circuit can comprise a battery, a capacitor bank, or other means to store electrical power, such as can be received wirelessly using the communication coil <NUM>.

In an example, the various leads and couplings that comprise the first segmented device <NUM> can include one or more electrical conductors. Power signals, electrostimulation signals, or other signals can be communicated among the different portions of the first segmented device <NUM> using the electrical conductors. For example, the housing coupling <NUM> can include a power conductor such that a battery in the second housing <NUM> can be used to power electrostimulation control circuitry in the first housing <NUM>.

In an example, the first segmented device <NUM> can comprise component parts that can be organized in various different configurations, such as to optimize implantation or to configure the device to best match a particular patient anatomy. That is, the device can be configured to accommodate anatomic variations among different patients. For example, different lead lengths can be selected, or the orientation or position of the different components along the signal chain can be adjusted.

In an example, the first housing <NUM> or the second housing <NUM> can use headers to connect with the various leads, or the first housing <NUM> and the second housing <NUM> can be integrated (e.g., attached at a point of manufacture rather than at a time of implantation) with their respective leads. By using a modular approach, component parts can be surgically updated or upgraded.

In an example, respective portions of the first segmented device <NUM> can be configured for implantation in submandibular triangle <NUM> and in the submental triangle <NUM> of a patient. That is, the first segmented device <NUM> can be configured to extend between the triangle regions, such as across a portion of a digastric muscle. Providing the portions of the first segmented device <NUM> in different triangles of the cervical region can help minimize interference between the first segmented device <NUM> and patient movement, such as due to activity of the digastric muscles. In an example, the first housing <NUM> and the second housing <NUM> can be differently sized such that a larger of the two housings can be disposed in the particular triangular region that offers more space. Such a distributed arrangement or implantation of the components of the first segmented device <NUM> can be helpful in maintaining patient comfort since muscles in the cervical region can be used for complex movement of the head, neck, mouth, tongue, and other areas.

<FIG> illustrates generally an example of a submandibular implantable device <NUM>. The submandibular implantable device <NUM> can be an implantable device that is configured for implantation at or in an anterior cervical region of a patient. For example, the submandibular implantable device <NUM> can be configured to be implanted in one or multiple different triangles of the cervical region, as further described below. That is, different segments or portions of the submandibular implantable device <NUM> can be implanted in the same triangle region or in respective different triangle regions in a cervical region of a patient.

The submandibular implantable device <NUM> includes an implantable device housing <NUM> that can include, among other things, power storage circuitry, electrostimulation generation circuitry, and control circuitry. Circuitry in the implantable device housing <NUM> can be coupled to an electrode assembly <NUM> using a power, data, and therapy signal lead <NUM>, and the electrode assembly <NUM> can be used to provide neuromodulation signals at a cervical neural target in a patient body. In an example, the circuitry in the implantable device housing <NUM> can be coupled to the electrode assembly <NUM> via a device header <NUM>.

In an example, the implantable device housing <NUM> can be coupled to a communication coil <NUM> using one or more conductors in the power, data, and therapy signal lead <NUM>. The communication coil can include a power communication coil and/or a telemetry antenna. In an example, the communication coil <NUM> can be coupled to a support member <NUM>. The support member <NUM> can include one or more support mounting features <NUM> for coupling the support member <NUM> to tissue. In an example, the support member <NUM> can include a housing mount <NUM> that is configured to receive or couple with the implantable device housing <NUM>. That is, the support member <NUM> can include a mounting structure or feature that can be configured to secure or retain the implantable device housing <NUM> together with the support member <NUM>. In an example, the implantable device housing <NUM> can include various features that are configured to mate with, or to be used together with, the housing mount <NUM>. For example, the housing mount <NUM> can include suture holes, and the device mounting feature <NUM> can comprise a through-hole or groove that is configured to receive a suture therein. A suture can then be used to join the implantable device housing <NUM> to the support member <NUM> using the housing mount <NUM>. In an example, the support member <NUM> can be configured to be coupled or otherwise affixed to the mylohyoid muscle <NUM>, such as in or near the submental triangle <NUM> or the submandibular triangle <NUM> of a patient.

In an example, the device mounting feature <NUM> can be configured to receive one or more sutures, bands, or flaps that are configured to loop around structures like a digastric tendon or a hyoid bone or other connective tissue, and can affix back to itself, thereby coupling the implantable device housing <NUM> to a stable piece of the anatomy.

<FIG> illustrates generally a first submandibular triangle example <NUM> that can include or use the submandibular implantable device <NUM> from the example of <FIG>. In the example, portions of the submandibular implantable device <NUM> can be implanted in a submandibular triangle region of a neck, such as between the anterior digastric muscle <NUM> and the posterior digastric muscle <NUM>.

In the example of <FIG>, the support member <NUM> of the submandibular implantable device <NUM> can be coupled to one or more anatomic structures in the submandibular triangle. For example, the support member <NUM> can be coupled to the anterior digastric muscle <NUM> using an anterior suture <NUM>, or to the posterior digastric muscle <NUM> using a posterior suture <NUM>, or to the mylohyoid muscle <NUM>, such as using one or more other sutures.

The implantable device housing <NUM> can be coupled to the same digastric structures as the support member <NUM>, or can be coupled to other anatomic structures in the submandibular triangle. For example, the implantable device housing <NUM> can be coupled to the mylohyoid muscle <NUM>, such as using a housing-tissue anchor <NUM>. In an example, the housing-tissue anchor <NUM> can include one or more sutures that can wrap around or through a portion of the implantable device housing <NUM> and the muscle tissue, to thereby affix the housing-tissue anchor <NUM> to tissue inside the submandibular triangle.

<FIG> illustrates generally a second submandibular triangle example <NUM> that can include or use the submandibular implantable device <NUM> from the example of <FIG>. In the example, the implantable device housing <NUM> can be coupled to the support member <NUM>, such as using the housing mount <NUM>. The assembly that includes the support member <NUM> and the implantable device housing <NUM> can be implanted in a submandibular triangle region of a neck, such as between the anterior digastric muscle <NUM> and the posterior digastric muscle <NUM>. In an example, the support mounting features <NUM> of the support member <NUM> can be used to couple respective sides of the assembly to the anterior digastric muscle <NUM> and the posterior digastric muscle <NUM>.

The example of <FIG> illustrates the implantable device housing <NUM> coupled to an outward-facing first surface of the support member <NUM>. That is, <FIG> shows the implantable device housing <NUM> facing toward skin or away from other internal cervical structures. In an example, the implantable device housing <NUM> can be coupled to an opposite second surface of the support member <NUM>, such as facing inward toward the mylohyoid muscle <NUM> and other internal cervical structures. The implantable device housing <NUM> can be coupled to the support member <NUM> using, for example, a housing-support anchor <NUM>, such as can include a suture, clip, cuff, or other means for coupling a flexible support substrate of the support member <NUM> to a structural housing.

The examples of <FIG> illustrate generally the submandibular implantable device <NUM> with the power, data, and therapy signal lead <NUM> extending away from the submandibular triangle to a hypoglossal nerve target. One or more other nerve targets can similarly be accessed using one or more other leads, such as using the same support member <NUM> and implantable device housing <NUM> and circuitry therein.

<FIG> illustrates generally an example of a method <NUM> that can include providing a neuromodulation therapy to multiple cranial nerves. The method <NUM> can optionally include or use the system <NUM> or other system configured for modulation of a nerve stimulation or blocking therapy.

At block <NUM>, the method <NUM> can include providing an implantable neuromodulation device in an anterior cervical region of a patient. For example, block <NUM> can include implanting the implantable system <NUM> (or one or more components thereof) in one or more of the submental triangle <NUM>, the submandibular triangle <NUM>, or the carotid triangle <NUM> in an anterior portion of a patient neck. In an example, block <NUM> can include implanting or coupling multiple different housings that comprise portions of the system <NUM> to various anatomic structures that are in or that border the various triangle regions in the anterior portion of the patient neck.

At block <NUM>, the method <NUM> can include providing a first lead, such as an electrode lead (e.g., a first instance of a stimulation lead(s) <NUM>), at or near a first cranial nerve target in the patient. Block <NUM> can include coupling the electrode lead to signal generator circuitry in a housing such as implanted with the neuromodulation device at block <NUM>. In an example, block <NUM> can include implanting a lead with electrodes that are disposed at or near one or more of the hypoglossal nerve <NUM>, the glossopharyngeal nerve <NUM>, the facial nerve <NUM>, the mandibular branch of the trigeminal nerve <NUM>, the vagus nerve <NUM>, or elsewhere in or near the head or neck of the patient. In an example, the method <NUM> can include, at block <NUM>, providing a second lead, such as an electrode lead (e.g., a second instance of a stimulation lead(s) <NUM>), at or near a second cranial nerve target in the patient. Block <NUM> can include coupling the electrode lead to signal generator circuitry in a housing such as implanted at block <NUM>. In an example, block <NUM> can include implanting a lead with electrodes that are disposed at or near one or more of the hypoglossal nerve <NUM>, the glossopharyngeal nerve <NUM>, the facial nerve <NUM>, the mandibular branch of the trigeminal nerve <NUM>, the vagus nerve <NUM>, or elsewhere in or near the head or neck of the patient.

At block <NUM>, the method <NUM> can include applying a first neuromodulation therapy to the first cranial nerve target, such as using first electrical signals from the signal generator circuitry (e.g., using the stimulation signal generator circuit <NUM>) and using electrodes of the first electrode lead. In an example, the therapy can include electrical signals that are configured to treat a particular patient disorder, such as can include one or more of OSA, heart failure, hypertension, or one or more other disorders discussed herein, among others.

At block <NUM>, the method <NUM> can include applying a second neuromodulation therapy to the second cranial nerve target, such as using second electrical signals from the signal generator circuitry (e.g., using the stimulation signal generator circuit <NUM>) and using electrodes of the second electrode lead. In an example, applying the first neuromodulation therapy at block <NUM> and applying the second neuromodulation therapy at block <NUM> can comprise portions of a common therapy that is configured to treat the same disorder or multiple disorders.

Some examples of implantable device housings for cervical implantation are generally represented herein as elongate, prismatic or cylindrical structures. The housings can include enclosures that can be hermetically sealed to protect electronics, circuitry, or other contents from the internal environment of a human body. The housings can be sized and configured to occupy a minimal volume, for example, to enhance patient comfort, or to reduce a risk of infection or complication during implantation, among other reasons.

In an example, a housing can be configured (e.g., sized, shaped, oriented) according to one or more characteristics of an implantation destination. For example, a shape of a housing can optionally be based on characteristics of a triangle in a cervical region of a patient. For example, differently shaped housings can be configured for use in the submental triangle <NUM> and in the submandibular triangle <NUM>. In an example, a housing for use in a triangle region can include a tapered structure such that, when the housing is implanted, the housing contours generally match or follow corresponding anatomical contours in the cervical region.

<FIG>, for example, illustrates generally a tapered housing <NUM> for a device to be implanted in or near a triangular cervical region of a patient. The tapered housing <NUM> can include a tapered structure, such as a rectangular frustum. The illustrated example of the tapered housing <NUM> includes a base surface <NUM> and an opposite top surface <NUM>. The tapered housing <NUM> can include tapered sidewalls <NUM>, such as can include trapezoidal portions, that can extend between the base surface <NUM> and the top surface <NUM>. In an example, a surface area of the top surface <NUM> can be less than a surface area of the base surface <NUM>. One or more headers can be coupled to or integrated with the tapered housing <NUM>, including at or along any one or more of the side surfaces, base surface <NUM>, and the top surface <NUM>.

In an example, the tapered housing <NUM> can be configured for implantation inside of at least a portion of the anterior triangle <NUM> of a patient. In an example, the base surface <NUM> can be configured for implantation at or adjacent to a portion of the mylohyoid muscle <NUM>, such that a tapered portion of the housing structure extends away from the mylohyoid muscle <NUM>.

In an example, the tapered housing <NUM> can include elongated tapered sidewalls <NUM>, and a surface characteristic of at least one of the sidewalls can be sized or configured to correspond to, or fit partially or entirely within, contours of a triangle region of the neck, such as within the submandibular triangle <NUM>, the submental triangle <NUM>, or the carotid triangle <NUM>. For example, the first implantable device <NUM> from the example of <FIG> can include a tapered housing with a base portion provided adjacent to the posterior digastric muscle <NUM>, and sidewalls that extend toward a region where the mandible <NUM> and anterior digastric muscle <NUM> are proximal or substantially adjacent, such that the device can occupy the submandibular triangle <NUM>. In other words, the device can include a base portion that is sized and configured to correspond to or match a length or width characteristic of the posterior digastric muscle <NUM> (e.g., between the mandible <NUM> and the hyoid bone <NUM>). The device can include a sidewall that is configured to correspond to or match a length or width characteristic of the anterior digastric muscle <NUM> (e.g., between the hyoid bone <NUM> and the mandible <NUM>), or the device can include a sidewall that is configured to correspond to or match a length or width characteristic of a lower edge portion of the mandible <NUM> (e.g., between the posterior digastric muscle <NUM> and the anterior digastric muscle <NUM>).

In an example, the third implantable device <NUM> from the example of <FIG> can include a tapered housing with a base portion provided, for example, adjacent to the omohyoid muscle <NUM>, and sidewalls that extend toward a region where the SCM <NUM> and the posterior digastric muscle <NUM> are proximal or substantially adjacent. In other words, the device can include a base portion that is sized and configured to correspond to or match a length or width characteristic of the portion of the omohyoid muscle <NUM> (e.g., a portion of the omohyoid muscle <NUM> that is inside the carotid triangle <NUM>). The device can include a sidewall that is configured to correspond to or match a length or width characteristic of the SCM <NUM> (e.g., a portion of the SCM <NUM> that is inside the carotid triangle <NUM>), or the device can include a sidewall that is configured to correspond to or match a length or width characteristic of the posterior digastric muscle <NUM> (e.g., a portion of the posterior digastric muscle <NUM> bounding the carotid triangle <NUM>, such as between the hyoid bone <NUM> and the SCM <NUM>). Accordingly, the third implantable device <NUM> can be configured with a housing that occupies the carotid triangle <NUM>.

In other examples, the tapered housing <NUM> can be configured for implantation at or adjacent to various other muscles, tendons, bones, or tissues, such as at or adjacent to a portion of the digastric muscle <NUM>, the SCM <NUM>, the omohyoid muscle <NUM>, or other tissue. Such devices or housings can be configured to occupy all or substantially all of a space available in a triangle region in a neck, such as the submandibular triangle <NUM>, the submental triangle <NUM>, or the carotid triangle <NUM>, among others.

The example of <FIG> illustrates the tapered housing <NUM> as including various abrupt edges or vertices. One or more of the edges or vertices, or adjacent surfaces, can optionally be chamfered or rounded. In an example, the tapered housing <NUM> can include a base or top surface that is at least partially rounded, such that the housing structure is at least partially (or entirely) a conical frustum. In an example, the top surface <NUM> or the base surface <NUM> can be non-planar, and the top surface <NUM> and the base surface <NUM> can be at least partially non-parallel.

In an example, the tapered housing <NUM> can include various headers on one or more of the surfaces or faces of the housing. In the example of <FIG>, the tapered housing <NUM> includes a first header <NUM> and a second header <NUM>. The headers can be configured to couple circuitry, sensors, or other components inside of the tapered housing <NUM> with leads or other devices outside of the tapered housing <NUM>. In the example of <FIG>, the first header <NUM> and the second header <NUM> are provided on adjacent side surfaces of the housing; other positions for the headers can similarly be used. In an example, a position of one or more of the headers can be influenced or determined by an implantation location or a nerve target location.

<FIG> illustrates generally an example of a cylindrical housing <NUM> for a device to be implanted in or near a triangular cervical region of a patient. The cylindrical housing <NUM> can include a capsule-shaped structure, such as including a cylinder that extends along a longitudinal axis and includes rounded ends or caps. The cylindrical housing <NUM> can enclose signal generator circuitry <NUM> and can have multiple headers, such as a first header <NUM> and a second header <NUM>, for interfacing the signal generator circuitry <NUM> with various leads. The first header <NUM> and the second header <NUM> can be disposed at opposite ends of the device or multiple headers can be provided on one end.

In an example, the cylindrical housing <NUM> can be configured for implantation along a portion of an anatomic target. For example, the cylindrical housing <NUM> can be configured to be coupled to a tissue target in a triangular region. For example, the cylindrical housing <NUM> can be configured to be coupled to the anterior digastric muscle <NUM>, or to the posterior digastric muscle <NUM>, or to the SCM <NUM>. In an example, the cylindrical housing <NUM> can be configured to be coupled to the SCM <NUM> inside of the carotid triangle <NUM>, and the cylindrical housing <NUM> can be coupled to a lead that extends outside of the carotid triangle <NUM>, such as similarly described above in the example of <FIG>.

<FIG> is a diagrammatic representation of a machine <NUM> within which instructions <NUM> (e.g., software, a program, an application, an applet, an app, or other executable code) for causing the machine <NUM> to perform any one or more of the methodologies discussed herein may be executed. The machine <NUM> can optionally comprise the implantable system <NUM>, the external system <NUM>, or components or portions thereof, or components or devices that can be coupled to at least one of the implantable system <NUM> and the external system <NUM>.

In an example, the instructions <NUM> may cause the machine <NUM> to execute any one or more of the methods, controls, therapy algorithms, signal generation routines, or other processes described herein. The instructions <NUM> transform the general, non-programmed machine <NUM> into a particular machine <NUM> programmed to carry out the described and illustrated functions in the manner described. The machine <NUM> may operate as a standalone device or may be coupled (e.g., networked) to other machines. In a networked deployment, the machine <NUM> may operate in the capacity of a server machine or a client machine in a server-client network environment, or as a peer machine in a peer-to-peer (or distributed) network environment. The machine <NUM> can comprise, but is not limited to, various systems or devices that can communicate with the implantable system <NUM> or the external system <NUM>, such as can include a server computer, a client computer, a personal computer (PC), a tablet computer, a laptop computer, a netbook, a set-top box (STB), a PDA, an entertainment media system, a cellular telephone, a smart phone, a mobile device, a wearable device (e.g., a smart watch), a smart home device (e.g., a smart appliance), other smart devices, a web appliance, a network router, a network switch, a network bridge, or any machine capable of executing the instructions <NUM>, sequentially or otherwise, that specify actions to be taken by the machine <NUM>. Further, while only a single machine <NUM> is illustrated, the term "machine" shall also be taken to include a collection of machines that individually or jointly execute the instructions <NUM> to perform any one or more of the methodologies discussed herein.

The machine <NUM> may include processors <NUM>, memory <NUM>, and I/O components <NUM>, which may be configured to communicate with each other via a bus <NUM>. In an example embodiment, the processors <NUM> (e.g., a Central Processing Unit (CPU), a Reduced Instruction Set Computing (RISC) processor, a Complex Instruction Set Computing (CISC) processor, a Graphics Processing Unit (GPU), a Digital Signal Processor (DSP), an ASIC, a Radio-Frequency Integrated Circuit (RFIC), another processor, or any suitable combination thereof) may include, for example, a processor <NUM> and a processor <NUM> that execute the instructions <NUM>. The term "processor" is intended to optionally include multi-core processors that may comprise two or more independent processors (sometimes referred to as "cores") that may execute instructions contemporaneously. Although <FIG> shows multiple processors <NUM>, the machine <NUM> may include a single processor with a single core, a single processor with multiple cores (e.g., a multi-core processor), multiple processors with a single core, multiple processors with multiples cores, or any combination thereof.

The instructions <NUM> may also reside, completely or partially, within the main memory <NUM>, within the static memory <NUM>, within a machine-readable medium <NUM> within the storage unit <NUM>, within at least one of the processors <NUM> (e.g., within the processor's cache memory), or any suitable combination thereof, during execution thereof by the machine <NUM>.

The I/O components <NUM> may include a variety of components to receive input, provide output, produce output, transmit information, exchange information, capture measurements, and so on. The specific I/O components <NUM> that are included in a particular machine will depend on the type of machine. For example, portable machines such as device programmers or mobile phones may include a touch input device or other such input mechanisms, while a headless server machine will likely not include such a touch input device. It will be appreciated that the I/O components <NUM> may include other components that are not shown in <FIG>. In various example embodiments, the I/O components <NUM> may include output components <NUM> and input components <NUM>. The output components <NUM> may include visual components (e.g., a display such as a plasma display panel (PDP), a light emitting diode (LED) display, a liquid crystal display (LCD), a projector, or a cathode ray tube (CRT)), acoustic components (e.g., speakers), haptic components (e.g., a vibratory motor, resistance mechanisms), other signal generators, and so forth. The input components <NUM> may include alphanumeric input components (e.g., a keyboard, a touch screen configured to receive alphanumeric input, a photo-optical keyboard, or other alphanumeric input components), point-based input components (e.g., a mouse, a touchpad, a trackball, a joystick, a motion sensor, or another pointing instrument), tactile input components (e.g., a physical button, a touch screen that provides location and/or force of touches or touch gestures, or other tactile input components), audio input components (e.g., a microphone), physiologic sensor components, and the like.

In further example embodiments, the I/O components <NUM> may include biometric components <NUM>, motion components <NUM>, environmental components <NUM>, or position components <NUM>, among others. For example, the biometric components <NUM> can include components to detect expressions (e.g., hand expressions, facial expressions, vocal expressions, body gestures, or eye tracking), measure biosignals (e.g., blood pressure, heart rate, body temperature, perspiration, or brain waves), identify a person (e.g., voice identification, retinal identification, facial identification, fingerprint identification, or electroencephalogram -based identification), and the like. The motion components <NUM> can include an acceleration sensor (e.g., an accelerometer), gravitation sensor components, rotation sensor components (e.g., a gyroscope), or similar. The environmental components <NUM> can include, for example, illumination sensor components (e.g., photometer), temperature sensor components (e.g., one or more thermometers that detect ambient temperature), humidity sensor components, pressure sensor components (e.g., barometer), acoustic sensor components (e.g., one or more microphones that detect background noise), proximity sensor components (e.g., infrared sensors that detect nearby objects), gas sensors (e.g., gas detection sensors to detection concentrations of hazardous gases for safety or to measure pollutants in the atmosphere), or other components that may provide indications, measurements, or signals corresponding to a surrounding physical environment. The position components <NUM> can include location sensor components (e.g., a GPS receiver component), altitude sensor components (e.g., altimeters or barometers that detect air pressure from which altitude may be derived), orientation sensor components (e.g., magnetometers), and the like.

Communication may be implemented using a wide variety of technologies. The I/O components <NUM> further include communication components <NUM> operable to couple the machine <NUM> to a network <NUM> or other devices <NUM> via a coupling <NUM> and a coupling <NUM>, respectively. For example, the communication components <NUM> may include a network interface component or another suitable device to interface with the network <NUM>. In further examples, the communication components <NUM> may include wired communication components, wireless communication components, cellular communication components, Near Field Communication (NFC) components, Bluetooth components, or Wi-Fi components, among others. The devices <NUM> may be another machine or any of a wide variety of peripheral devices such as can include other implantable or external devices.

The various memories (e.g., memory <NUM>, main memory <NUM>, static memory <NUM>, and/or memory of the processors <NUM>) and/or storage unit <NUM> can store one or more sets of instructions and data structures (e.g., software) embodying or used by any one or more of the methodologies or functions described herein. These instructions (e.g., the instructions <NUM>), when executed by processors <NUM>, cause various operations to implement the disclosed embodiments, including various neuromodulation or neurostimulation therapies or functions supportive thereof.

The above description includes references to the accompanying drawings, which form a part of the detailed description.

Method examples described herein can be machine or computer-implemented at least in part, such as using the implantable system <NUM>, the external system <NUM>, the machine <NUM>, or using the other systems, devices, or components discussed herein. Some examples can include a computer-readable medium or machine-readable medium encoded with instructions operable to configure an electronic device to perform methods, such as neuromodulation therapy control methods, as described in the above examples, such as to treat one or more diseases or disorders. In an example, the instructions can include instructions to receive sensor data from one or more physiologic sensors and, based on the sensor data, titrate a therapy.

Claim 1:
An implantable system for neuromodulation of cranial nerves, the system comprising:
a first housing (<NUM>) configured for implantation in an anterior cervical region of a patient, at or under a mandible of the patient;
a first electrode lead (<NUM>) coupled to the first housing (<NUM>), the first electrode lead (<NUM>) comprising at least one electrode configured to be disposed at or near a first cranial nerve target in the patient, wherein the first cranial nerve target comprises a main body of a hypoglossal nerve of the patient or a branch of the hypoglossal nerve of the patient; and
a signal generator circuit provided in the first housing and configured to generate electrical neuromodulation signals for delivery to the cranial nerve target using the at least one electrode of the first electrode lead (<NUM>),
the system further comprising:
a second electrode lead (<NUM>) coupled to the first housing (<NUM>; <NUM>), characterised in the second electrode lead comprising at least one electrode configured to be disposed at or near a second cranial nerve target in the patient, and wherein the signal generator circuit is configured to generate respective neuromodulation signals for delivery to the first and second cranial nerve targets using the electrodes on the first and second electrode leads (<NUM>, <NUM>) to treat obstructive sleep apnea.