Sleep apnea treatment system and method

Abstract

The present disclosure provides a method for treating sleep apnea in a patient by activating an implantable nerve stimulation implant to stimulate the genioglossus nerve branch and / or the genioglossus muscle. The present disclosure also provides a method for implanting a nerve stimulation implant in the genioglossus muscle proximal to the genioglossus nerve branch. The present disclosure also provides a sleep apnea treatment system and a guide for a sleep apnea treatment system.

Description

Background Art

[0001] Background There are a number of treatments for sleep apnea, such as continuous positive airway pressure devices (CPAP), surgically implanted nerve stimulation devices, oral mouthpieces, and medications. Generally, known devices have poor effects in reducing the apnea-hypopnea index (AHI) and / or are highly invasive device procedures that can only be performed by surgeons. Furthermore, commercially available nerve stimulation devices and positive airway pressure (PAP) devices mainly function as independent devices and can only partially treat OSA or CSA.

[0002] US2022370797A1 discloses a technique for implanting a signal delivery device for treating sleep apnea. Specifically, US2022370797A1 teaches a percutaneous implantation method of a signal delivery device for targeting the medial branch of the hypoglossal nerve. As described in US2022370797A1, stimulation of the medial branch of the hypoglossal nerve can innervate oral muscles such as the genioglossus muscle and the geniohyoid muscle, which tend to pull the tongue forward (anteriorly), thus reducing the tendency of the palatal soft tissue to protrude into the patient's airway. However, the medial branch also includes retractor muscles that innervate muscles such as the styloglossus muscle and the hyoglossus muscle, which tend to pull the soft tissue backward (posteriorly) and / or can curl the tongue left or right within the oral cavity - both of which are motor responses that can occlude the patient's airway. Therefore, it is important to stimulate the medial branch in a way that produces a net protrusion effect or a net protrusion motor response. This also includes, for example, stimulating the medial branch in such a way that the retractor muscles are not fully activated.

[0003] The problem with the method taught in US2022370797A1 is that the position of the implant relative to the medial branch of the hypoglossal nerve and the electrical stimulation signal determine the balance of protrusion - retraction stimulation. Therefore, the implantation surgery requires high precision and adjustment, resulting in a relatively complex and invasive surgery that generally requires surgical intervention such as the use of an endoscope during adjustment.

[0004] US20130218230A1 discloses a method of stimulating the hypoglossal nerve to control the position of a patient's tongue, for example, to prevent obstructive sleep apnea. US20130218230A1 suggests that by stimulating the distal branches of the hypoglossal nerve, only some of the tongue muscles, particularly those that cause the protrusion of the tongue, can be targeted to produce only the desired tongue movement.

[0005] As described in US20130218230A1, one of the problems with targeting the distal branches of the hypoglossal nerve is that the surgical approach to these distal branches becomes more difficult, and the branches become progressively smaller the more distal the electrode placement is. Appropriate electrode design for such small branches becomes more difficult, the system used to stimulate the branches becomes less robust, and the chance of damage to these more delicate structures becomes more likely. Also, the implantation surgery becomes more difficult.

[0006] Therefore, it is useful to provide an implantable nerve stimulation device system that targets the distal branches of the hypoglossal nerve and an implantation surgery that addresses the above difficulties. SUMMARY OF THE INVENTION

[0007] Summary According to the present invention, there is provided a method of treating sleep apnea in a patient, the method comprising activating an implantable nerve stimulation implant to stimulate a hypoglossal nerve branch. In one example, the implantable nerve stimulation implant is operable to stimulate the distal branches of the hypoglossal nerve, particularly the genioglossus nerve branches. In other examples, the implantable nerve stimulation implant is operable to stimulate the medial branches of the hypoglossal nerve.

[0008] In one example, the method comprises activating an implantable nerve stimulation implant to stimulate the genioglossus nerve branches and / or the genioglossus muscle. Stimulating the genioglossus nerve branches and / or the genioglossus muscle can cause the protrusion of the tongue and reduce sleep apnea.

[0009] In one example, an implantable nerve stimulation implant is operable to directly stimulate the genioglossus nerve branch and / or the genioglossus muscle. Such direct stimulation can be effected by implanting the electrodes of the nerve stimulation implant into the genioglossus muscle in proximity to the genioglossus nerve branch. By implanting the electrodes in proximity to the genioglossus nerve branch, for example within 2 cm or within 1 cm of the genioglossus nerve branch, the amplitude of the stimulation signal can be limited such that only the genioglossus nerve branch is stimulated. This can avoid stimulation of other parts of the hypoglossal nerve and other muscles, thereby avoiding retraction of the tongue. In one example, an implantable nerve stimulation implant is operable to stimulate only the genioglossus nerve branch and / or the genioglossus muscle. In one example, an implantable nerve stimulation implant is operable to not stimulate the medial branch of the hypoglossal nerve.

[0010] In one example, an implantable nerve stimulation implant operates to stimulate the genioglossus nerve branch with a first stimulation signal and the genioglossus muscle with a second stimulation signal. The first and second stimulation signals can be generated simultaneously or sequentially. The first and second stimulation signals can be generated in response to detected physiological parameters or patient movement as further described below.

[0011] In one example, an implantable nerve stimulation implant operates to stimulate the genioglossus muscle with a stimulation signal having a frequency of from about 2 Hz to about 150 Hz, such as from about 2 Hz to about 100 Hz, such as from about 2 Hz to about 50 Hz, such as from about 2 Hz to about 40 Hz, such as from about 2 Hz to about 30 Hz, such as from about 2 Hz to about 20 Hz, such as from about 2 Hz to about 15 Hz, such as from about 2 Hz to about 10 Hz.

[0012] In one example, the stimulation signal for stimulating the genioglossus muscle has a peak amplitude of from 0.1 mA to 10 mA, such as from 0.1 mA to 5 mA. Such low frequency, low amplitude muscle stimulation can avoid discomfort to the patient.

[0013] In one example, an implantable nerve stimulation implant operates to stimulate the genioglossus nerve branch with a stimulation signal having a frequency of from about 20 Hz to about 1500 Hz, such as from about 20 Hz to about 1000 Hz, such as from about 20 Hz to about 500 Hz, such as from about 20 Hz to about 400 Hz, such as from about 20 Hz to about 300 Hz, such as from about 20 Hz to about 200 Hz, such as from about 20 Hz to about 150 Hz, such as from about 20 Hz to about 100 Hz.

[0014] In one example, stimulation of the genioglossus nerve branch and / or the genioglossus muscle includes a stimulation signal having a plurality of pulses, each pulse having a pulse width of from 30 microseconds to 2,000 microseconds. In one example, the inter-pulse interval can be from 30 microseconds to 2,000 microseconds.

[0015] In one example, an electrode that provides a stimulation signal to a nerve or muscle can operate as an anode or as a cathode. The nerve stimulation implant can be controllable to vary between anode stimulation and cathode stimulation.

[0016] In one example, a nerve stimulation implant can include an electrode lead having an electrode. The method can include implanting the electrode lead into the genioglossus muscle proximal to the patient's genioglossus nerve branch. Thus, the nerve stimulation implant can directly stimulate the genioglossus nerve branch within the genioglossus muscle. In one example, the electrode can be implanted within about 2 cm of the genioglossus nerve branch, preferably within about 1 cm of the genioglossus nerve branch.

[0017] In one example, a nerve stimulation implant can further include a housing portion. The electrode lead can extend from the housing portion. The method can include implanting the housing portion into the subcutaneous tissue of the patient.

[0018] In some examples, the method may further include transmitting wireless power from an external device to an implantable nerve stimulation implant. In some examples, the nerve stimulation implant may include a wireless power receiver (e.g., an antenna). The wireless power receiver may be provided on a housing portion and / or an electrode lead. In some examples, the wireless power transmitted to the implantable nerve stimulation implant includes frequencies from 300 MHz to 3 GHz, such as from 400 MHz to 2.5 GHz, such as from 433 MHz to 2.4 GHz.

[0019] In some examples, the method may further include detecting at least one physiological parameter by a sensor. In some examples, the at least one physiological parameter is the patient's respiratory rate, the patient's electromyogram (EMG), the patient's electrocardiogram (ECG), the patient's oxygen saturation, the patient's body temperature, the patient's heart rate, the patient's blood pressure and may include at least one of.

[0020] In some examples, the method may include generating a stimulation signal in response to the at least one detected physiological parameter. The method may include adapting the stimulation signal based on the at least one detected physiological parameter.

[0021] In some examples, the method may further include detecting at least one movement of the patient by a sensor, such as the patient's respiratory movement, the patient's jaw movement, the patient's chest movement, the patient's diaphragm movement and may include detecting at least one of.

[0022] In one example, the method may include generating a stimulation signal in response to at least one detected movement. The method may include adapting the stimulation signal based on the at least one detected movement.

[0023] In one example, the method is by a sensor to detect physiological parameters or movements of a patient indicative of sleep apnea, such as, a decrease in respiratory rate, an electromyogram (EMG) profile indicative of sleep apnea, an electrocardiogram (ECG) profile indicative of sleep apnea, a decrease in oxygen saturation, an increase in body temperature, an increase in heart rate, an increase in blood pressure, or respiratory movement, jaw movement, chest movement or diaphragmatic movement and may further include detecting at least one of them.

[0024] In one example, the method may include generating a stimulation signal in response to at least one detected physiological parameter or movement of a patient indicative of sleep apnea. The method may include adapting the stimulation signal based on the at least one detected physiological parameter or movement of a patient indicative of sleep apnea.

[0025] In one example, the method may further include controlling a nerve stimulation implant to stimulate the genioglossus nerve branch and / or the genioglossus muscle in response to at least one detected physiological parameter of a patient and / or at least one detected movement of a patient and / or at least one physiological parameter or movement of a patient indicative of sleep apnea. Thus, the nerve stimulation implant can be actuated to provide stimulation at a time determined based on the parameters detected by the sensor and / or with a stimulation signal set based on the parameters detected by the sensor. The stimulation signal can be set with a particular period and / or frequency and / or amplitude and / or duration and / or pulse width and / or inter-pulse interval in response to the parameters detected by the sensor. The stimulation signal can be generated to stimulate the genioglossus nerve branch and / or the genioglossus muscle.

[0026] In one example, the method includes detecting a respiratory rate of a patient by a sensor and stimulating the genioglossus nerve branch and / or the genioglossus muscle in synchronization with the detected respiratory rate. In another example, the method includes stimulating the genioglossus nerve branch and / or the genioglossus muscle in synchronization with a predetermined target respiratory rate. In one example, the method may include stimulating the genioglossus nerve branch and / or the genioglossus muscle at the start of an inhalation cycle of a patient.

[0027] In one example, the method may further include determining a classification of sleep apnea from at least one detected physiological parameter and / or at least one movement of a patient, particularly determining whether the detected sleep apnea includes obstructive sleep apnea (OSA), central sleep apnea (CSA), or a combination of OSA and CSA. The method may include adapting a stimulation signal based on the determined classification of sleep apnea.

[0028] In one example, the method may further include operating a second implantable nerve stimulation implant to stimulate the patient's phrenic nerve and / or hypoglossal nerve. Stimulation of the phrenic nerve and / or hypoglossal nerve may be responsive to the physiological parameters detected as described above, the patient's movement, or the classification of sleep apnea. Stimulation of the phrenic nerve and / or hypoglossal nerve may be responsive to detected apnea events. Stimulation of the phrenic nerve and / or hypoglossal nerve may be synchronized with stimulation of the genioglossus nerve branches and / or the genioglossus muscle.

[0029] In one example, the method may further include operating a continuous positive airway pressure (CPAP) device to provide positive pressure to the patient's airway. Operation of the CPAP device may be responsive to the physiological parameters detected as described above, the patient's movement, or the classification of sleep apnea. Operation of the CPAP device may be responsive to detected apnea events. Operation of the CPAP device may be synchronized with stimulation of the genioglossus nerve branches and / or the genioglossus muscle.

[0030] In one example, the method may further include controlling the nerve stimulation implant or each nerve stimulation implant and optionally the CPAP device based on at least one detected patient physiological parameter and / or at least one detected patient movement. In one example, the method may include activating the nerve stimulation implant and / or a second nerve stimulation implant and / or the CPAP device based on the determined classification of sleep apnea. In one example, the method may include activating a nerve stimulation device device to stimulate the genioglossus nerve branch and / or the genioglossus muscle if the classification of sleep apnea is determined to be obstructive sleep apnea (OSA). In one example, if the classification of sleep apnea is determined to be central sleep apnea (CSA), the method may include activating a second nerve stimulation implant to stimulate the phrenic nerve and / or the cervical nerve snare. In one example, if the classification of sleep apnea is determined to be obstructive sleep apnea (OSA), the method may include activating the CPAP device to provide positive pressure to the patient. In one example, if the classification of sleep apnea is determined to be a combination of obstructive sleep apnea and central sleep apnea, the method may: activating a nerve stimulation device device to stimulate the genioglossus nerve branch and the genioglossus muscle, and activating a second nerve stimulation implant to stimulate the phrenic nerve and / or the cervical nerve snare and activating the CPAP device to provide positive pressure to the patient at least one of may be included.

[0031] In one example, the sensor can be integrated with a nerve stimulation implant. In other examples, the sensor can be an external sensor. In one example, there can be more than one sensor arranged to detect more than one physiological parameter or the patient's movement, and each sensor can be integrated with a nerve stimulation implant or an external device. In one example, the nerve stimulation implant includes an oxygen saturation sensor and / or an ECG sensor, and an external accelerometer is provided to detect the patient's movement, such as jaw or head movement.

[0032] According to a further aspect of the present invention, a system for treating a patient's sleep apnea is also provided, the system including a nerve stimulation implant implantable proximal to the hypoglossal nerve branch of the patient and operable to stimulate the hypoglossal nerve branch.

[0033] In one example, the implanted nerve stimulation implant is operable to stimulate the patient's genioglossus nerve branch and / or the genioglossus muscle. In other examples, the implanted nerve stimulation implant is operable to stimulate the medial branch of the hypoglossal nerve.

[0034] In one example, the implanted nerve stimulation implant is operable to stimulate the genioglossus muscle with a stimulation signal having a frequency of about 2 Hz to about 150 Hz, such as about 2 Hz to about 100 Hz, such as about 2 Hz to about 50 Hz, such as about 2 Hz to about 40 Hz, such as about 2 Hz to about 30 Hz, such as about 2 Hz to about 20 Hz, such as about 2 Hz to about 15 Hz, such as about 2 Hz to about 10 Hz.

[0035] In one example, the stimulation signal for stimulating the genioglossus muscle has a peak amplitude of 0.1 mA to 10 mA, such as 0.1 mA to 5 mA. Such low-frequency, low-amplitude muscle stimulation can avoid discomfort to the patient.

[0036] In one example, an implanted nerve stimulation implant is operable to stimulate the genioglossus nerve branch with a stimulation signal having a frequency of from about 20 Hz to about 1500 Hz, such as from about 20 Hz to about 1000 Hz, such as from about 20 Hz to about 500 Hz, such as from about 20 Hz to about 400 Hz, such as from about 20 Hz to about 300 Hz, such as from about 20 Hz to about 200 Hz, such as from about 20 Hz to about 150 Hz, such as from about 20 Hz to about 100 Hz.

[0037] In one example, a nerve stimulation implant is operable to stimulate the genioglossus nerve branch and / or the genioglossus muscle with a stimulation signal having a plurality of pulses, each pulse having a pulse width of 30 microseconds to 2,000 microseconds. In one example, the inter-pulse interval can be from 30 microseconds to 2,000 microseconds.

[0038] In one example, a nerve stimulation implant includes an electrode implantable in the genioglossus muscle proximal to the patient's genioglossus nerve branch, and a signal generator for generating a stimulation signal to stimulate the patient's genioglossus nerve branch and / or genioglossus muscle. In one example, the nerve stimulation implant is implantable in the genioglossus muscle adjacent to the genioglossus nerve branch for direct stimulation of the genioglossus muscle and / or genioglossus nerve branch.

[0039] In one example, the nerve stimulation implant is a battery-less implant and includes a wireless power receiver. In one example, the system further includes an external device. The external device can include a wireless power transmitter. The wireless power transmitter is for transmitting wireless power to the nerve stimulation implant when the nerve stimulation implant is implanted in the genioglossus muscle. The nerve stimulation implant includes a wireless power antenna for receiving the wireless power. In one example, the external device includes a signal generator for generating a stimulation signal. In other examples, the signal generator is provided in the nerve stimulation implant.

[0040] In one example, the system may further include sensors arranged to detect physiological parameters of at least one patient and / or the movement of at least one patient.

[0041] In one example, the at least one physiological parameter is the respiratory rate of the patient, the electromyogram (EMG) of the patient, the electrocardiogram (ECG) of the patient, the oxygen saturation of the patient, the body temperature of the patient, the heart rate of the patient, the blood pressure of the patient including one or more of.

[0042] In one example, the stimulation signal generated by the signal generator can be generated according to at least one detected physiological parameter. The stimulation signal can be adapted based on at least one detected physiological parameter.

[0043] In one example, the movement of at least one patient is the respiratory movement of the patient, the jaw movement of the patient, the chest movement of the patient, the diaphragmatic movement of the patient including at least one of.

[0044] In one example, the stimulation signal generated by the signal generator can be generated according to at least one detected movement of the patient. The stimulation signal can be adapted based on at least one detected movement of the patient.

[0045] In one example, the system is based on the detected physiological parameters and / or the detected movement of the patient, for example, a decrease in respiratory rate, an electromyogram (EMG) profile indicating apnea during sleep, an electrocardiogram (ECG) profile indicating apnea during sleep, a decrease in oxygen saturation, an increase in body temperature, an increase in heart rate, an increase in blood pressure, or respiratory movement, jaw movement, chest movement or diaphragmatic movement and may further include a controller configured to determine the onset or occurrence of sleep apnea based on at least one of them.

[0046] In one example, the stimulation signal generated by the signal generator may be generated in response to the detected onset or occurrence of sleep apnea. The stimulation signal may be adapted based on the detected onset or occurrence of sleep apnea.

[0047] In one example, the signal generator may be configured to generate a stimulation signal in response to at least one detected physiological parameter of a patient and / or at least one detected movement of a patient and / or a physiological parameter or movement of a patient indicative of at least one sleep apnea. Thus, the nerve stimulation implant can be actuated to provide stimulation at a time determined based on the parameters detected by the sensor and / or with a stimulation signal set based on the parameters detected by the sensor. The stimulation signal may be adapted or set to a specific period and / or frequency and / or amplitude and / or duration and / or pulse width and / or pulse interval in response to the parameters detected by the sensor.

[0048] In one example, the system includes a nerve stimulation implant including electrodes, a signal generator for generating a stimulation signal, and a wireless power system for providing power to the nerve stimulation implant, and may further include a second nerve stimulation implant including wherein the electrodes are implantable to stimulate the patient's phrenic nerve and / or cervical nerve snare.

[0049] In one example, the system may further include a continuous positive airway pressure (CPAP) device operable to provide positive pressure to a patient.

[0050] In one example, the system may further include a controller configured to control the nerve stimulation implant or each nerve stimulation implant and optionally the CPAP device based on at least one detected patient physiological parameter and / or at least one detected patient movement. The controller may be provided on one of the nerve stimulation implant, the CPAP device, or an external device.

[0051] In one example, the controller may be configured to determine a classification of sleep apnea, particularly to determine whether the detected sleep apnea includes obstructive sleep apnea (OSA), central sleep apnea (CSA), or a combination of OSA and CSA, based on at least one detected physiological parameter and / or at least one patient movement.

[0052] In one example, the controller may be configured to activate the nerve stimulation implant and / or a second nerve stimulation implant and / or the CPAP device based on the determined classification of sleep apnea.

[0053] According to a further aspect of the invention, a method of implanting a nerve stimulation implant in a patient for treating sleep apnea, wherein the nerve stimulation implant includes a housing portion and a flexible elongate electrode lead extending from the housing portion and having electrodes, the method comprising providing a delivery device having a first needle for holding the housing portion of the nerve stimulation implant and a second needle for holding the electrode lead, wherein the second needle has a higher gauge than the first needle, wherein the second needle extends beyond the first needle and wherein the second needle is retractable in a direction towards the first needle. Inserting a second needle into the patient at an insertion point under the patient's jaw; Advancing the second needle through the patient's tissue along the insertion direction towards the patient's genioglossus muscle; When the second needle is within the patient's genioglossus muscle, retracting the second needle and implanting an electrode lead and an electrode proximal to the genioglossus nerve branch within the genioglossus muscle; and A method is also provided that includes discharging the housing portion from the first needle and implanting the housing portion under the skin.

[0054] In one example, the insertion point is proximal to the posterior edge of the patient's mandibular symphysis.

[0055] In one example, the insertion direction includes a first angle (β) in the mandibular plane of the patient's jaw and a second angle (θ) in the sagittal plane of the patient. In one example, the first angle (β) is from about ±15 degrees to about ±30 degrees, such as from about ±18 degrees to about ±25 degrees, such as from about ±20 degrees to about ±23 degrees, such as about ±22 degrees, particularly about ±21.8 degrees. In one example, the second angle is from about 40 degrees to about 65 degrees, such as from about 45 degrees to about 55 degrees, such as from about 40 degrees to about 50 degrees, such as from about 47 degrees to about 49 degrees, particularly about 48.1 degrees.

[0056] In one example, the method includes scanning the patient and determining the insertion direction based on the scan.

[0057] In one example, the method further includes rotating the delivery device before discharging the housing portion from the first needle such that the housing portion is implanted in a different direction relative to the electrode lead. In one example, the delivery device is rotated towards a position where the first needle is parallel to the skin surface and the tip of the first needle is disposed under the skin. In one example, by rotating the delivery device, the electrode lead is bent. In one example, the first needle includes a slot through which a portion of the electrode lead passes when the delivery device is rotated.

[0058] In one example, the method further includes using an ultrasonic device to monitor the position of the second needle.

[0059] In one example, the method further includes placing a guide on the patient, the guide having a guide channel that defines an insertion direction of the second needle, and placing the second needle in the guide channel. In one example, the method further includes removing the guide while the second needle is placed percutaneously.

[0060] According to a further aspect of the invention, a nerve stimulation implant having electrodes; a delivery device for implanting the nerve stimulation implant such that the electrodes are implanted in the patient's genioglossus muscle proximal to the genioglossus nerve branch; and a guide configurable on the patient, configured to receive a portion of the delivery device and including a guide channel that defines an insertion direction of the delivery device for implanting the nerve stimulation implant in the genioglossus muscle adjacent to the genioglossus nerve branch A sleep apnea treatment system including the same is also provided.

[0061] In one example, the nerve stimulation implant includes a housing portion and a flexible elongated electrode lead extending from the housing portion. In one example, the delivery device includes a first needle adapted to hold the housing portion of the nerve stimulation implant and a second needle adapted to hold the electrode lead, the second needle having a higher gauge than the first needle and extending beyond the first needle.

[0062] In one example, the second needle is retractable in a direction towards the first needle for implanting the electrode lead.

[0063] In one example, the guide channel is movable to align the guide channel with the insertion point of the patient. In one example, the guide channel is rotatable to change the insertion direction. Thus, the guide can be adapted to the specific anatomical structure of the patient.

[0064] In one example, the guide further includes an accessory for an ultrasonic scanner. The ultrasonic scanner can be attached to the guide such that an ultrasonic sensor window is directed towards the implantation site to monitor the position of the nerve stimulation implant during implantation.

[0065] In one example, the guide channel includes a slot for removing the guide while the delivery device is being implanted percutaneously. Thus, the delivery device can be rotated during implantation, for example, after the implantation of the electrodes.

[0066] In one example, the guide includes a positioning portion that can be positioned relative to the patient. In one example, the positioning portion is formed to be placed on the patient's jaw. In one example, the positioning portion is formed to be received within the patient's mouth. In one example, the positioning portion is configured to engage the patient's mandible. In one example, the positioning portion includes a brace configured to engage the patient's mandible and the patient's neck and / or shoulder.

[0067] According to a further aspect of the invention, there is provided a guide for a delivery device for percutaneously implanting a nerve stimulation implant into the patient's genioglossus muscle proximal to the genioglossus nerve branch, wherein the guide a positioning portion that can be positioned relative to the patient; and a guide channel configured to receive a portion of the delivery device, the guide channel defining an insertion direction for the delivery device for implanting a nerve stimulation implant into the genioglossus muscle in proximity to the genioglossus nerve branch.

[0068] In one example, the delivery device includes a first needle adapted to hold the housing portion of the nerve stimulation implant and a second needle adapted to hold the electrode lead, wherein the guide channel is configured to receive the second needle.

[0069] In one example, the guide channel is movable to align the guide channel with the patient's insertion point. In one example, the guide channel is rotatable to change the insertion direction.

[0070] In one example, the guide further includes an accessory for an ultrasonic scanner.

[0071] In one example, the guide channel includes a slot for removing the guide while the delivery device is being percutaneously implanted.

[0072] In one example, the positioning portion is formed to be disposed on the patient's jaw. In one example, the positioning portion is formed to be received within the patient's mouth. In one example, the positioning portion is configured to engage the patient's lower jaw. In one example, the positioning portion includes a neck brace configured to engage the patient's lower jaw and the patient's neck.

[0073] According to one aspect of the present disclosure, there is provided a method of percutaneously implanting one or more nerve stimulation implants such that the electrodes of the nerve stimulation implant are implanted proximal to the sublingual nerve branch, particularly the horizontal sublingual nerve branch. The percutaneous implantation avoids the submandibular gland and conduction pathways as well as vascular structures. The nerve stimulation implant can be implanted by combining anatomical landmarks and ultrasonic guidance.

[0074] According to another aspect of the present disclosure, a biosensor integrated into a nerve stimulation implant can detect signs of exhalation and trigger activation of the device and / or general patient diagnosis. Such a biosensor can include a bioimpedance or biopotential-based sensing device that converts each signal into ECG, EMG, EDA format to interpret electrocardiographic detection of heart rate, blood pressure, and / or inspiratory muscle contractions. The nerve stimulation implant can communicate with an external wearable device or an external power unit to combine datasets and / or trigger activation of the device in synchronization with the patient's natural respiratory rate.

[0075] According to one aspect of the present disclosure, there is provided a method of treating a patient, comprising: A) detecting a physiological parameter of the patient; and B) activating a nerve stimulation in synchronization with the patient's respiratory rate. In one example, the method includes detecting the patient's respiratory rate. In one example, the method includes stimulating the patient's hypoglossal nerve, particularly the genioglossus nerve branch, in synchronization with the patient's respiratory rate.

[0076] According to another aspect of the present disclosure, a biosensor integrated into a wearable device is used to detect signs of exhalation to trigger device activation and / or general patient diagnosis. Such biosensors may include electrocardiographic detection of heart rate, blood pressure and / or inspiratory muscle contraction, and further biosensor impedance or biopotential-based sensing devices that convert each signal into ECG, EMG, EDA format for interpreting oxygen and carbon dioxide (for detecting signs of hypoxia or anoxia), and the use of a microphone and / or accelerometer for detecting signs of airway obstruction. BRIEF DESCRIPTION OF THE DRAWINGS

[0077] To facilitate identification of discussion of particular elements or acts, the most significant digit of the reference number refers to the figure number in which that element first appears.

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DETAILED DESCRIPTION OF THE INVENTION

[0078] Detailed Description FIG. 1 shows a portion of the nervous system in the region of the head 102 and neck 104 of patient 100. As shown, the left hypoglossal nerve 108 is a motor nerve originating from the medulla oblongata of the brainstem and extends toward the jaw of patient 100. The hypoglossal nerve 108 innervates all extrinsic and intrinsic muscles of the tongue except the palatoglossus muscle. The hypoglossal nerve 108 includes a medial branch 110 and more distal branches. The medial branch 108 of the hypoglossal nerve innervates the genioglossus muscle 112, as well as oral muscles such as the geniohyoid muscle, stylohyoid muscle, and hyoglossus muscle. Some of these muscles cause protrusion of the tongue, while others cause retraction of the tongue. The most distal branch of the hypoglossal nerve 108 forms the genioglossus nerve branch 106 and innervates the genioglossus muscle 112. Contraction of the genioglossus muscle 112 causes tongue protrusion. The right hypoglossal nerve is present on the opposite side and is understood to have the same anatomical structure.

[0079] As described below, the present invention provides an implantable nerve stimulation implant that targets the genioglossus nerve branch 106 within the genioglossus muscle 112. The difficulty in providing such an implant is that an active stimulation device (electrode) needs to be implanted sufficiently close to the genioglossus nerve branch 106 for effective stimulation, that an electronic device necessary for the nerve stimulation implant to transmit and receive wireless communication needs to be implanted sufficiently close to the skin surface, and that the nerve stimulation implant needs to be oriented such that it can receive wireless power. The nerve stimulation implant, delivery device, and implant procedure detailed herein address these issues and provide an implantable system for treating sleep apnea that includes stimulation of the genioglossus nerve branch 106 within the genioglossus muscle 112.

[0080] Figure 2 shows an exemplary nerve stimulation implant 200 having a housing portion 202 and electrode leads 204 extending from the housing portion 202. The housing portion 202 may house the electronic device assembly of the nerve stimulation implant 200. The electronic device assembly within the housing portion 202 may include a wireless power receiver (e.g., an antenna), and a signal generator. Further, the electronic device assembly may include a receiver / transmitter of a wireless communication device. Further, the electronic device assembly may include sensor electronics. In one example, the electronic device assembly may include a printed circuit board (PCB). In one example, the housing portion 202 is sealed. In one example, the nerve stimulation implant 200 is battery - less.

[0081] The electrode leads 204 extend from the housing portion 202 and are flexible. The electrode leads 204 are connected to the housing portion 202 by lead connectors 210. The electrode leads 204 include at least one electrode 206a, and in this example, include four electrodes 206a, 206b, 206c, 206d. In other examples, the electrode leads 204 may include one, two, three, five, six or more electrodes. The electrodes 206a, 206b, 206c, 206d are spaced apart from each other at the distal end of the electrode leads 204. The electrodes 206a, 206b, 206c, 206d are connected to the electronics within the housing portion 202. The electrodes 206a, 206b, 206c, 206d are metallic and are preferably platinum - iridium alloy or titanium.

[0082] In one example, electrodes 206a, 206b, 206c, 206d are actuated by an electronic device assembly housed in housing portion 202 to provide electrical stimulation to stimulate a patient's nerve. In other examples, electrodes 206a, 206b, 206c, 206d are actuated by an electronic device assembly housed in housing portion 202 to sense or detect nerve signals. In other examples, electrodes 206a, 206b, 206c, 206d are actuated by an electronic device assembly housed in housing portion 202 to detect other (non - nerve) parameters of the patient, such as bio - impedance, blood pressure or heart rate. In one example, at least two of electrodes 206a, 206b, 206c, 206d may include different materials, particularly different metals, and be actuated to detect differential bio - impedance. In one example, electrodes 206a, 206b, 206c, 206d are operable in a first mode to detect nerve signals and in a second mode to stimulate the patient's nerve. In one example, some of electrodes 206a, 206b, 206c, 206d are operable to detect nerve signals and other electrodes are operable to stimulate the nerve. In one example, some of electrodes 206a, 206b, 206c, 206d are operable to detect / stimulate the nerve and other electrodes are operable to sense other (non - nerve) parameters. In one example, nerve stimulation implant 200 is implantable to sense and / or stimulate the hypoglossal nerve 108 shown in FIG. 1, particularly the genioglossus nerve branch 106. In other examples, nerve stimulation implant 200 within the genioglossus muscle 112 may be implantable to sense and / or stimulate the phrenic nerve and / or the cervical nerve snare. Sensing and stimulation of the hypoglossal nerve and / or the phrenic nerve and / or the cervical nerve snare may provide treatment for sleep apnea. In other examples, nerve stimulation implant 200 may be implantable to sense and / or stimulate other nerves, including the greater occipital nerve, the tibial nerve, the sacral nerve (e.g., to treat urinary incontinence), or the vagus nerve (e.g., to regulate pancreatic secretion).

[0083] In one example, during operation, electrodes 206a, 206b, 206c, 206d of the nerve stimulation implant 200 are provided with an electrical signal, such as a current, to stimulate the nerve. In one example, the electrical signal can be a voltage-controlled stimulation.

[0084] In other examples, the nerve stimulation implant 200 can further operate as a diagnostic implant, such as a nerve diagnostic implant, and can be operable to detect one or more nerve signals in the nerve. In such examples, electrodes 206a, 206b, 206c, 206d are operable to detect nerve signals. The nerve signals can be analyzed for state detection, monitoring, and / or diagnostic purposes.

[0085] In other examples, the nerve stimulation implant 200 can further operate as a diagnostic implant operable to detect one or more physiological parameters, such as body temperature, heart rate, electromyogram (EMG), electrocardiogram (ECG), respiratory rate, blood pressure, oxygen saturation, and / or blood gas concentration (e.g., oxygen, carbon dioxide, carbon monoxide).

[0086] In one example, the housing portion 202 may have an outer diameter of less than about 5 millimeters, such as from about 1 millimeter to about 5 millimeters, such as from about 1 millimeter to about 3 millimeters, such as about 3 millimeters. The housing portion 202 may have a length of up to about 30 millimeters, such as up to about 25 millimeters, such as up to about 20 millimeters, such as about 20 millimeters. In one example, the electrode lead 204 may have a diameter of from about 0.3 millimeter to about 1.5 millimeters, such as from about 0.5 millimeter to 1.3 millimeters, such as about 0.8 millimeter. The electrode lead 204 may have a length of up to about 200 millimeters, such as up to about 150 millimeters, such as up to about 120 millimeters, such as about 120 millimeters. The electrodes 206a, 206b, 206c, 206d may each have a length (along the electrode lead 204) of up to about 15 millimeters, such as up to about 10 millimeters, such as up to about 5 millimeters, such as about 3 millimeters. The electrodes 206a, 206b, 206c, 206d may be arranged along the electrode lead 204 at intervals of at least 2 millimeters, such as at least 3 millimeters, such as at least 5 millimeters from each other.

[0087] However, it is understood that the dimensions of the housing portion 202 may correspond to the size of the electronic device assembly within the housing portion 202 and that the length of the electrode lead 204 may correspond to the anatomical structure surrounding the target nerve, such that a shorter or longer electrode lead 204 may be appropriate depending on the depth of the nerve within the patient's tissue.

[0088] Also, as shown in FIG. 2, the housing portion 202 further includes one or more ring electrodes 208a, 208b, 208c, 208d. The ring electrodes 208a, 208b, 208c, 208d are spaced apart from each other and extend at least partially in the circumferential direction of the housing portion 202. In this example, the housing portion 202 includes four ring electrodes 208a, 208b, 208c, 208d. In other examples, the housing portion 202 may include one, two, three, five, six or more ring electrodes. The ring electrodes 208a, 208b, 208c, 208d are connected to electronic devices within the housing portion 202, for example via feedthroughs. The ring electrodes 208a, 208b, 208c, 208d are metallic and are preferably platinum-iridium alloy or titanium.

[0089] In one example, the ring electrodes 208a, 208b, 208c, 208d are operable to sense and / or stimulate a patient's nerve in the same manner as the electrodes 206a, 206b, 206c, 206d described above. In one example, the ring electrodes 208a, 208b, 208c, 208d are operable to detect one or more physiological parameters, such as body temperature, heart rate, electromyogram (EMG), electrocardiogram (ECG), respiratory rate, blood pressure, oxygen saturation, and / or blood gas concentration (e.g., oxygen, carbon dioxide, carbon monoxide).

[0090] Figures 3A and 3B show a first example of implanting the nerve stimulation implant 200 of FIG. 2 into the patient 100 shown in FIG. 1. As shown in FIG. 3A, the nerve stimulation implant 200 is implanted under the patient 100's jaw. The electrode lead 204 extends proximally to the genioglossus nerve branch 106 of the hypoglossal nerve 108 within the genioglossus muscle 112, the genioglossus nerve branch 106 of the right hypoglossal nerve 108 in this example. The housing portion 202 is implanted in the subcutaneous tissue of the neck 104. As further described below, the housing portion 202 is implanted so as to be substantially parallel to the skin of the neck 104. The external device 302 is attached to the neck 104 in alignment with the housing portion 202. The external device 302 can provide wireless power supply to the nerve stimulation implant 200 and / or wireless communication with the nerve stimulation implant 200. The external device 302 can be operable to control the nerve stimulation implant 200. In a preferred example, the nerve stimulation implant 200 is battery-less and the external device 302 provides power for operating the nerve stimulation implant 200.

[0091] The nerve stimulation implant 200 shown in FIGS. 3A and 3B can be used to detect and / or treat sleep apnea. For example, the nerve stimulation implant 200 can be operative to detect one or more indicators of sleep apnea, such as heart rate, respiratory rate, jaw movement, chest movement, diaphragmatic movement, and / or electromyogram (EMG). In particular, one or more of the electrodes 206a, 206b, 206c, 206d and / or one or more of the ring electrodes 208a, 208b, 208c, 208d can be operative to detect one or more indicators of sleep apnea. In one example, the nerve stimulation implant 200 can be operative to stimulate the genioglossus nerve branch 106 of the right hypoglossal nerve 108 within the genioglossus muscle 112. In particular, one or more of the electrodes 206a, 206b, 206c, 206d can be operative to stimulate the genioglossus nerve branch 106 of the right hypoglossal nerve 108 within the genioglossus muscle 112. Such stimulation causes innervation of the genioglossus muscle 112 that pulls the tongue forward to treat obstructive sleep apnea (OSA). The stimulation can directly innervate the genioglossus muscle 112 (particularly the portion of the genioglossus muscle 112 proximal to the electrode lead 204) and / or can stimulate the genioglossus nerve branch 106 to innervate the genioglossus muscle 112.

[0092] It is understood that the nerve stimulation implant 200 can alternatively be implanted in the other hypoglossal nerve (left hypoglossal nerve). Stimulation of one hypoglossal nerve, such as the right or left hypoglossal nerve 108, can be referred to as unilateral hypoglossal nerve stimulation.

[0093] FIG. 4 shows a further example of implanting the nerve stimulation implant 200 of FIG. 2 into the patient 100 shown in FIG. 1. In this example, a first nerve stimulation implant 200 is implanted in the right hypoglossal nerve 402 in the same manner described with reference to FIGS. 3A and 3B, and a second nerve stimulation implant 200 is implanted in the left hypoglossal nerve 404. The nerve stimulation implant 200 implanted in the left hypoglossal nerve 404 is implanted in the same manner described with reference to FIGS. 3A and 3B, but the electrode lead 204 is implanted proximal to the left hypoglossal nerve 404.

[0094] As shown, one external device 302 may be provided to power and / or communicate with both the power and / or nerve stimulation implant 200. Alternatively, various external devices 302 may be provided for two nerve stimulation implants 200. In some examples, the two nerve stimulation implants 200 may communicate wirelessly directly with each other or both may communicate wirelessly with the external device 302.

[0095] The nerve stimulation implant 200 operates in the same manner as described with reference to FIGS. 3A and 3B to detect, for example, one or more indicators of sleep apnea and / or stimulate the right hypoglossal nerve 402 and the left hypoglossal nerve 404 and / or the genioglossus muscle 112. Such stimulation may cause innervation of the genioglossus muscle 112 that pulls the tongue forward to reduce obstructive sleep apnea (OSA). The stimulation may directly innervate the genioglossus muscle 112 (particularly the portion of the genioglossus muscle 112 proximal to the electrode lead 204) and / or stimulate the genioglossal nerve branch 106 to innervate the genioglossus muscle 112.

[0096] Stimulation of both the left hypoglossal nerve 404 and the right hypoglossal nerve 402 may be referred to as bilateral hypoglossal stimulation.

[0097] Figures 5A and 5B show a further example of implanting the nerve stimulation implant 200 of FIG. 2 into the patient 100 shown in FIG. 1. In this example, two nerve stimulation implants 200 are implanted into the right hypoglossal nerve 402 and the left hypoglossal nerve 404 respectively, as described with reference to FIG. 4. Optionally, one nerve stimulation implant 200 is provided to the right hypoglossal nerve 402 or the left hypoglossal nerve 404. A third nerve stimulation implant 504 is implanted in the patient's neck, and the electrode lead 508 is implanted proximal to the phrenic nerve 502, particularly the right phrenic nerve 502. The nerve stimulation implant 504 is implanted to stimulate the phrenic nerve 502 within the cervical nerve sheath or at the location where the phrenic nerve 502 branches from the cervical nerve sheath. The nerve stimulation implant 504 is the same as the nerve stimulation implant 200 described with reference to FIG. 2 and is implanted to sense and / or stimulate the phrenic nerve 502. The phrenic nerve 502 innervates the diaphragm, and stimulation of the phrenic nerve 502 can induce inspiration, which can help reduce central sleep apnea (CSA) by improving the regulation of the patient's breathing. Stimulating the phrenic nerve 502 in addition to or instead of the right and left hypoglossal nerves 402, 404 can provide treatment for a combination of obstructive sleep apnea (OSA) and central sleep apnea (CSA), or for one or the other of obstructive sleep apnea (OSA) and central sleep apnea (CSA).

[0098] As shown in FIGS. 5A and 5B, the housing portion 506 of the nerve stimulation implant 504 can be implanted in the subcutaneous tissue, and the external device 510 can be attached to the patient's skin in alignment with the housing portion 506 to provide wireless power and / or communication for the nerve stimulation implant 504. In one example, the external device 510 can be separate from the external device 302, or it can be the antenna of the external device 302. In other examples, the external device 302 can directly supply power to the nerve stimulation implant 504 and / or communicate with the nerve stimulation implant 504. In one example, each of the nerve stimulation implant 200 and the nerve stimulation implant 504 can communicate wirelessly with each other, or they can all communicate wirelessly with the external device 302 or each external device 302.

[0099] It is understood that the nerve stimulation implant 504 can alternatively be implanted in the other phrenic nerve (right phrenic nerve). Stimulation of one phrenic nerve, such as the right or left phrenic nerve, can be referred to as unilateral phrenic nerve stimulation.

[0100] FIG. 6 shows a further example where a second nerve stimulation implant 504 is implanted in the left phrenic nerve 602, in addition to the first nerve stimulation implant 504 implanted in the right phrenic nerve 604 and two nerve stimulation implants 200 implanted in the right hypoglossal nerve 402 and the left hypoglossal nerve 404, respectively. The second nerve stimulation implant 504 can be implanted in the cervical nerve sheath or at the position where the left phrenic nerve 602 and the right phrenic nerve 604 branch from the cervical nerve sheath to stimulate the left phrenic nerve 602 and the right phrenic nerve 604.

[0101] The external device 510 and / or the external device 302 can supply power to the second nerve stimulation implant 504 and / or communicate with the second nerve stimulation implant 504, similar to the first nerve stimulation implant.

[0102] In addition to, or instead of, the hypoglossal nerves 402, 404, stimulating the left phrenic nerve 602 and / or the right phrenic nerve 604 can provide a treatment for a combination of obstructive sleep apnea (OSA) and central sleep apnea (CSA), or for either obstructive sleep apnea (OSA) or central sleep apnea (CSA).

[0103] Stimulation of both the left phrenic nerve 602 and the right phrenic nerve 604 can be referred to as bilateral phrenic nerve stimulation.

[0104] In some examples, the first and / or second nerve stimulation implant 504 can be implanted to stimulate the cervical nerve snares near the phrenic nerve 502.

[0105] FIG. 7 shows a delivery device 700 for implanting the nerve stimulation implant 200 of FIG. 2 into the hypoglossal nerve 108, as shown in any of FIGS. 3-6. The delivery device 700 can further be used to implant the nerve stimulation implant 200 into the phrenic nerve 502 and / or the cervical nerve snares, as shown in FIGS. 5A-6.

[0106] As shown in FIG. 7, the delivery device 700 includes a handle 702 and a first needle 704 that is fixed to the handle 702 and extends from the handle 702. A second needle 706 extends from the first needle 704 in a direction away from the handle 702. The second needle 706 is retractable relative to the first needle 704 by actuating a control slider 708, as further described below. The first needle 704 is larger (has a lower gauge) than the second needle 706. In one example, the first needle 704 can have a gauge of 6 gauge to 15 gauge, such as 10 gauge. In one example, the second needle 706 can have a gauge of 15 gauge to 25 gauge, such as 20 gauge.

[0107] FIG. 8 shows a cross-section through the delivery device 700 of FIG. 7, and FIGS. 9A and 9B show details of the first needle 704 and the second needle 706. The second needle 706 is slidably received within the first needle 704 and extends beyond the first needle 704 away from the handle 702. The second needle 706 is retractable into the first needle 704 during operation, as described in detail below. The control slider 708 is operable to retract and extend the second needle 706 relative to the first needle 704 and the handle 702. The control slider 708 is operably connected to the second needle 706 by a rack and pinion mechanism. The rack and pinion mechanism includes a first rack portion 802 connected to the control slider 708 and extending within the handle 702. A second rack portion 806 is connected to the second needle 706 and extends within the handle 702. A pinion 804 is rotatably mounted to the handle 702 and acts between the first rack portion 802 and the second rack portion 806. Thus, by moving the control slider 708 towards the handle 702, the second rack portion 806 and the second needle 706 move towards the handle 702 - i.e., the second needle 706 retracts into the first needle 704.

[0108] As shown in FIG. 8, the handle 702 includes a guide portion 810 extending in a direction opposite to the first needle 704 from the handle 702. The control slider 708 is slidable along the guide portion 810. The guide portion 810 shows one or more stop positions, in this example four stop positions 808a, 808b, 808c, 808d, which provide predetermined operating positions for the control slider 708. The stop positions 808a, 808b, 808c, 808d may include holes or grooves, and the control slider 708 may include ball detents for engaging the holes or grooves to stop the control slider 708 at the stop positions 808a, 808b, 808c, 808d. Thus, during use of the delivery device 700, as described in detail below, the control slider 708 can be moved along the guide portion 810 between the various stop positions 808a, 808b, 808c, 808d to move the second needle 706 to various predetermined positions.

[0109] As shown in FIGS. 8, 9A and 9B, the nerve stimulation implant 200 shown in FIG. 2 is received in the delivery device 700. In particular, the housing portion 202 is received in the first needle 704, and the electrode lead 204 is received in the second needle 706. As described further below, during use, the electrode lead 204 is implanted into the patient by retraction of the second needle 706, and then the housing portion 202 can be ejected from the first needle 704 in a two-stage implantation process.

[0110] In this example, the housing portion 202 is oriented such that the lead connector 210 faces in the direction of the handle 702. The electrode lead 204 extends from the lead connector 210 and is covered by the housing portion 202 before entering the second needle 706. As shown in FIGS. 7 and 8, the first needle 704 includes a slot 710 for receiving the portion of the electrode lead 204 covered by the housing portion 202 within the first needle 704. The slot 710 advantageously allows the housing portion 202 to be implanted at different angles with respect to the electrode lead 204 without applying excessive bending stress to the electrode lead 204, as described below.

[0111] FIGS. 10A - 10L show a method of implanting the nerve stimulation implant 200 into a patient using the delivery device 700 described with reference to FIGS. 7 - 9B. In this example, the nerve stimulation implant 200 is implanted to target the genioglossus nerve branch 106 of the hypoglossal nerve 108 within the genioglossus muscle 112, as shown in FIG. 1.

[0112] As shown in FIG. 10A, initially, the nerve stimulation implant 200 is provided within the delivery device 700 in the manner described with reference to FIGS. 7 - 9B. In particular, the second needle 706 is in the extended position. The ultrasonic device 1002 is used to guide the second needle 706 towards the genioglossus nerve branch 106 of the hypoglossal nerve 108 during implantation.

[0113] The second needle 706 enters the patient's tissue at the insertion point 1010. The insertion point 1010 is positioned as follows: with the patient's head tilted backward and the neck in a hyperextended state, the operator identifies the posterior edge of the mandibular symphysis below the midline. This point is the insertion point 1010 of the second needle 706. As further described with reference to FIGS. 13A - 15B, the insertion point 1010 can be positioned using the guide 1302 and / or scans, particularly ultrasound or X - rays.

[0114] The second needle 706 is inserted into the insertion point 1010 in a predefined insertion direction with respect to the patient. In particular, the insertion direction is defined by two angles: θ and β. The insertion direction is determined based on the method described in more detail with reference to FIGS. 12A - 12C.

[0115] Once the insertion point 1010 and the insertion direction are determined, as shown in FIG. 10B, the second needle 706 is pushed into the patient's tissue, penetrating the skin 1006 and inserting into the subcutaneous tissue 1004. The second needle 706 is pushed towards the genioglossus muscle 112, particularly the genioglossus nerve branch 106 of the hypoglossal nerve 108. The ultrasound device 1002 can be used to provide an image of the position of the second needle 706 and guide it so that the second needle 706 is close to the genioglossus nerve branch 106.

[0116] As shown in FIG. 10C, the position of the second needle 706, and thus the position of the electrode lead 204, can be tested by partially retracting the second needle 706 to expose at least a portion of the electrodes 206a, 206b, 206c, 206d on the electrode lead 204. In this example, as shown in an enlarged detail, the second needle 706 is retracted to expose the electrodes 206c and 206d. Referring to FIG. 8, the second needle 706 can be retracted to this position by moving the control slider 708 from the first stop position 808a to the second stop position 808b.

[0117] At the position shown in FIG. 10C, the position of the electrode lead 204 can be tested by supplying power to the nerve stimulation implant 200. The nerve stimulation implant 200 can be powered by a power system provided to the delivery device 700 or by an external device. The nerve stimulation implant 200 can be powered and controlled to provide sensing or stimulation to determine whether the electrode lead 204 is properly positioned relative to the genioglossus nerve branch 106. This test may include monitoring the patient's response to stimulation by the nerve stimulation implant 200.

[0118] As shown in FIG. 10D, if the position of the electrode lead 204 is determined to be unacceptable, the second needle 706 can be re-extended, specifically by moving the control slider 708 back to the first stop position 808a. Thereafter, for example, as shown in FIG. 10E, the delivery device 700 can be operated to move to a better position relative to the genioglossus nerve branch 106. Repositioning the second needle 706 may include rotating the delivery device 700 to bring the second needle 706 closer to being parallel to the genioglossus nerve branch 106.

[0119] Preferably, the end of the electrode lead 204 having the electrodes 206a, 206b, 206c, 206d is substantially parallel to the genioglossus nerve branch 106 such that each of the electrodes 206a, 206b, 206c, 206d can be activated to sense and / or stimulate the genioglossus nerve branch 106. Repositioning the second needle 706 may also include percutaneously positioning the tip of the first needle 704 in the patient, for example, in the skin 1006 or subcutaneous tissue 1004.

[0120] As shown in FIG. 10E, when it is determined that the second needle 706 is properly positioned relative to the lingual nerve branch 106 of the genioglossus muscle 112, the second needle 706 can be retracted more fully and implanted into the electrode lead 204. As shown in FIG. 8, the second needle 706 can be fully retracted by moving the control slider 708 to the fourth stop position 808d.

[0121] Preferably, as shown in FIG. 10F, anti-migration tines 1008 are arranged to fix the electrode lead 204 in position by retracting the second needle 706. In particular, the anti-migration tines 1008 can be spring tines attached to the electrode lead 204 between the housing portion 202 and the electrodes 206a, 206b, 206c, 206e. Thus, the anti-migration tines 1008 are not released during the position test described with reference to FIG. 10C. However, when the second needle 706 is retracted more fully, the anti-migration tines 1008 are released from within the second needle 706 and arranged outwardly to fix the electrode lead 204 in position.

[0122] As shown in FIG. 10G, when the electrode lead 204 is implanted and preferably fixed, the delivery device 700 is partially withdrawn from the patient such that the first needle 704 is removed from the subcutaneous tissue 1004 and the skin 1006. The delivery device 700 can be rotated either simultaneously or subsequently. The slack of the electrode lead 204 due to the arrangement of the electrode lead 204 of the first needle 704 and the second needle 706, and the slot 710 of the first needle 704 (see FIGS. 7 to 9B) allow the delivery device 700 to be retracted and rotated without applying tensile stress or bending stress to the electrode lead 204. Advantageously, this can prevent the electrode lead 204 from coming out of the implantation position. In particular, as shown in FIG. 11, when the delivery device 700 is rotated, the portion of the electrode lead 204 initially covered by the housing portion 202 within the first needle 704 can move out of the first needle 704 through the slot 710.

[0123] As shown in FIGS. 10G and 10H, the delivery device 700 is rotated so that the first needle 704 approaches parallel to the skin 1006. Advantageously, this allows the housing portion 202 to be implanted at an angle different from the electrode lead 204, particularly an angle close to parallel to the skin 1006.

[0124] As shown in FIG. 10H, when the delivery device 700 is rotated, the first needle 704 is repositioned transcutaneously to implant the housing portion 202.

[0125] As shown in FIG. 10I, preferably the second needle 706 is partially repositioned to assist the movement of the first needle 704 through the patient's skin 1006 and subcutaneous tissue 1004. The second needle 706 can be partially repositioned by moving the control slider 708 to the third stop position 808c, as shown in FIG. 8.

[0126] As shown in FIG. 10J, the first needle 704 is pushed into the patient's skin 1006 and subcutaneous tissue 1004 until the housing portion 202 is implanted. During this movement, the electrode lead 204 bends and passes through the slot 710 of the first needle 704, preventing the implanted end of the electrode lead 204 from coming off.

[0127] FIG. 10K shows the ejection of the housing portion 202 from the first needle 704. The housing portion 202 is ejected from the first needle 704 by moving the control slider 708 to the maximum position towards the handle 702. At this position, the end of the first rack portion 802, most clearly shown in FIG. 8, pushes the housing portion 202 out of the end of the first needle 704 as shown in FIG. 10K. The operator can gradually withdraw the delivery device 700 from the patient's tissue while pushing the control slider 708 to the maximum position so that the housing portion 202 is implanted in the space formed by the first needle 704.

[0128] Thereafter, the delivery device 700 can be removed from the patient, and FIG. 10L shows the implantable nerve stimulation implant 200. As shown, the end of the electrode lead 204 having the electrodes is implanted and fixed proximal to the genioglossus nerve branch 106 within the genioglossus muscle 112. The housing portion 202 is implanted in the skin 1006, and the electrode lead 204 is bent between the housing portion 202 and the electrodes.

[0129] Advantageously, the housing portion 202 is oriented substantially parallel to the skin 1006, which can be beneficial for wireless power supply and / or wireless communication between the housing portion 202 and an external device. Further, due to this implantation position, the nerve stimulation implant 200 can target the genioglossus nerve branch 106 within the genioglossus muscle 112 where there is a minimum amount of tissue suitable for implanting the housing portion 202.

[0130] Accordingly, the method described with reference to FIGS. 10A - 10L advantageously enables the nerve stimulation implant 200 to target the genioglossus nerve branch 106 within the genioglossus muscle 112 using a minimally invasive method.

[0131] Figures 12A - 12C show a method for determining the insertion point 1010 and the insertion direction 1202 of the delivery device 700 during the implantation method described with reference to Figures 10A - 10K. The method for determining the insertion point 1010 and the insertion direction 1202 can be obtained based on Benbassat et al (Benbassat B, Cambronne C, Gallini A, Chaynes P, Lauwers F, de Bonnecaze G. The specific branches leading to the genioglossus muscle: three - dimensional localisation using skin reference points. Surg Radiol Anat. 2020 May;42(5):547 - 555. doi: 10.1007 / s00276 - 019 - 02390 - w. Epub 2019 Dec 9. PMID: 31820050.).

[0132] The insertion point 1010 is located at the posterior edge of the mandibular symphysis on the midline. The operator can find and mark this by feeling the mandibular symphysis through the patient's skin. Ultrasonic and / or X - ray scans can provide additional information for specifying the location of the insertion point 1010.

[0133] As shown in Figures 12A - 12C, the insertion direction is defined by a first angle 1206 in a cross - section 1204. The cross - section 1204 is the plane of the patient's submandibular muscles when the neck 104 is in the hyperextended position, which is also the plane of the patient's submandibular skin as shown in Figure 12D. The first angle 1206 is positive or negative depending on whether the left or right hypoglossal nerve is the target. The first angle 1206 is the angular offset from the longitudinal section 1208 of the patient in the cross - section 1204. As described below, the longitudinal section 1208 is the mid - plane, or sagittal plane, of the patient 100.

[0134] As shown in FIGS. 12A - 12C, the insertion direction is also defined by a second angle 1210 in the longitudinal section 1208. The longitudinal section 1208 is the median (sagittal) plane of the patient and is perpendicular to the transverse section 1204. The second angle 1210 is the angular offset from the transverse section 1204 in the longitudinal section 1208.

[0135] In one example, the first angle 1206 can be from about ±15 degrees to about ±30 degrees, such as from about ±18 degrees to about ±25 degrees, such as from about ±20 degrees to about ±23 degrees. In a particular example, the first angle 1206 can be about ±22 degrees, particularly about ±21.8 degrees.

[0136] In one example, the second angle 1210 can be from about 40 degrees to about 65 degrees, such as from about 45 degrees to about 55 degrees, such as from about 40 degrees to about 50 degrees. In a particular example, the second angle 1210 is, for example, from about 47 degrees to about 49 degrees, particularly about 48.1 degrees.

[0137] However, it is understood that the first angle 1206 and the second angle 1210 may vary for different patients and can be determined for a particular patient prior to the implantation surgery, for example, based on ultrasound scans or other scan information.

[0138] In some instances, the insertion depth is also determined. The insertion depth is the approximate distance from the skin to the genioglossus nerve branches 106 within the genioglossus muscle 112. When determining the insertion depth, it can be obtained based on the following formula defined by Benbassat et al (Benbassat B, Cambronne C, Gallini A, Chaynes P, Lauwers F, de Bonnecaze G. The specific branches leading to the genioglossus muscle: three-dimensional localisation using skin reference points. Surg Radiol Anat. 2020 May;42(5):547-555. doi: 10.1007 / s00276-019-02390-w. Epub 2019 Dec 9. PMID: 31820050.): [Number] [Number] [Wherein: L is the insertion depth. GH is a measurement variable defined as the distance from the posterior edge of the mandibular symphysis to the hyoid bone along the midline (in the cross-section). The distance GH is shown in FIG. 12E.]

[0139] In other instances, the insertion depth can be determined prior to the implantation surgery based on medical images such as, for example, X-rays or ultrasound scans. In other instances, the operator can use a scanner, particularly an ultrasound scanner, to monitor the insertion depth and position. In other instances, the insertion depth is not determined and instead, the operator can insert the delivery device 700 to a predetermined depth. In other instances, the insertion depth can be tested and / or confirmed by generating a stimulation signal and testing the patient's response to the stimulation signal and / or by using bioimpedance sensing when the electrodes are implanted near the nerve.

[0140] As shown in FIGS. 12D and 12E, a scan, in this case a head X-ray, can be taken prior to the implantation surgery to assist in determining the appropriate insertion direction for a particular patient. As shown, the X-ray can be used to determine the angle 1212 between the submandibular plane and the muscular plane of the patient's jaw, enabling proper positioning of the cross-section 1204 as described above. Further, if necessary, the variable GH can be measured from the X-ray as shown in FIG. 12E.

[0141] FIGS. 13A - 15B show a first example of a guide 1302 for use in the implantation method described with reference to FIGS. 10A - 10L. As shown in FIGS. 13A and 13B, the guide 1302 includes a positioning portion 1304 shaped to conform to the patient's jaw for positioning the guide 1302 with respect to the patient. The positioning portion 1304 is mounted on a rail 1306 via a slider 1308, and the ultrasonic device 1002 is also mounted on the rail 1306. Thus, the position of the positioning portion 1304 is adjustable with respect to the ultrasonic device 1002. In this way, the ultrasonic sensor window 1310 of the ultrasonic device 1002 is properly positioned with respect to the patient during implantation.

[0142] As shown in FIG. 13B, the rail 1306 includes a guide channel 1312 for the second needle 706 of the delivery device 700 shown in FIG. 7. The guide channel 1312 is sized and shaped to define the insertion point and insertion direction of the second needle 706 for implanting the nerve stimulation implant 200 into the digastric branch 106 of the hypoglossal nerve 108 as described with reference to FIGS. 10A - 10F. The guide channel 1312 includes a slot 1314 for removing the guide 1302 prior to rotating the delivery device 700 as described with reference to FIG. 10G. Thus, the guide 1302 is used to guide the second needle 706 to the insertion point 1010 (see FIG. 10A) and maintain the insertion direction until the second needle 706 is properly positioned with respect to the digastric branch 106.

[0143] The rail 1306 can be moved to align the guide channel 1312 with the insertion point based on the image obtained from the ultrasonic device 1002. As shown in FIGS. 14A and 14B, the slider 1308 includes a lock 1402 for fixing the position of the positioning portion 1304 along the rail 1306 once the guide channel 1312 is aligned with the insertion point. Therefore, the guide 1302 is adjustable according to a specific patient.

[0144] The rail 1306 includes a guide channel portion 1404, and the guide channel 1312 extends through this guide channel portion 1404. Thereby, the guide channel 1312 defines the insertion direction of the second needle 706 as described above.

[0145] In particular, as shown in FIGS. 15A and 15B, the insertion direction is defined by a first angle 1206 and a second angle 1210 determined based on the method described with reference to FIGS. 12A - 12C.

[0146] According to the method described with reference to FIGS. 12A - 12C, the first angle 1206 can be from about ±15 degrees to about ±30 degrees, for example from about ±18 degrees to about ±25 degrees, for example from about ±20 degrees to about ±23 degrees. In a particular example, the first angle 1206 can be about ±22 degrees, particularly about ±21.8 degrees. In an example, the guide 1302 is adjustable so that it can adjust the first angle 1206 defined by the guide channel portion 1404, for example within the above range.

[0147] In an example, the second angle 1210 can be from about 40 degrees to about 60 degrees, for example from about 45 degrees to about 55 degrees, for example from about 40 degrees to about 50 degrees. In a specific example, the second angle 1210 is, for example, from about 47 degrees to about 49 degrees, particularly about 48.1 degrees. In an example, the guide 1302 is adjustable so that it can adjust the second angle 1210 defined by the guide channel portion 1404, for example within the above range.

[0148] Prior to use, a scan (e.g., an x-ray such as the x-rays shown in FIGS. 12D and 12E) may be taken to determine appropriate first angle 1206 and second angle 1210.

[0149] FIGS. 16-18 show further examples of guides 1602, 1702, 1802.

[0150] In the example of FIG. 16, guide 1602 includes a brace 1604 positionable between a patient's mandible 1606 and neck / shoulder 1608. A guide channel portion 1610 having a guide channel is attached to brace 1604 via attachment portion 1612. Attachment portion 1612 is movably attached to brace 1604 such that the position and orientation of guide channel portion 1610 are adjustable.

[0151] Advantageously, since brace 1604 is positioned relative to the patient's mandible 1606, the variation between the mandibular plane and the muscle plane (see FIG. 12D) is not overly large. Further, guide 1602 allows an operator to fully adjust the position and orientation of guide channel portion 1610, and thus the position and orientation of delivery device 700 can also be provided in an optimal position and orientation for insertion of delivery device 700. Brace 1604 also advantageously acts to limit patient movement.

[0152] In the example of FIG. 17, the guide 1702 includes a mouthpiece 1704. The mouthpiece 1704 is inserted into the patient's oral cavity and is fixed in the oral cavity when the patient bites on the mouthpiece 1704. The mouthpiece 1704 extends over the patient's jaw and includes a guide channel portion 1706 that is located approximately at the posterior edge of the mandibular joint. To provide adjustability of the position and orientation of the guide channel portion 1706, the guide channel portion 1706 can be movably, e.g., rotatably, attached to the mouthpiece 1704. The ultrasonic device 1002 is also attached to the guide 1702 in the same manner as described above. The ultrasonic device 1002 is attached to the guide 1702 so as to be directed towards the patient for imaging the position of the implant during use.

[0153] In this example, a first inclinometer 1708 is provided on the ultrasonic device 1002. The first inclinometer 1708 measures the inclination of the ultrasonic device 1002. During use, based on the ultrasonic image obtained by the ultrasonic device 1002, the ultrasonic device 1002 is moved to be substantially parallel to the cross-section (see 1204, FIGS. 12A - 12C). A second inclinometer 1710 is provided on the guide channel portion 1706. Thus, the angular difference between the angle measurement at the first inclinometer 1708 and the insertion point 1010 gives the angular offset between the cross-section and the guide channel portion 1706. In this way, the guide channel portion 1706 can be positioned and oriented appropriately for implantation.

[0154] In the example of FIG. 18, the guide 1802 includes a mouthpiece 1804. The mouthpiece 1804 is inserted into the patient's oral cavity and is fixed in the oral cavity when the patient bites on the mouthpiece 1804. The mouthpiece 1804 extends over the patient's jaw and includes a guide channel portion 1806 that is located approximately at the posterior edge of the mandibular joint. In this example, the guide channel portion 1806 is fixedly attached to the mouthpiece 1804, and this guide 1802 does not provide adjustability of the insertion position and orientation. However, the guide 1802 can be customized for a particular patient, for example, by 3D printing based on a previous scan. Alternatively, a number of guides 1802 with various sizes and dimensions can be provided, and the optimal guide 1802 can be selected based on the scan.

[0155] FIG. 19 shows a nerve stimulation implant system 1900 that includes a hypoglossal nerve stimulation implant 1904, a phrenic nerve stimulation implant 1906, and a continuous positive airway pressure device (CPAP device) 1908. As described with reference to FIGS. 3A - 4, the hypoglossal nerve stimulation implant 1904 can include one or two nerve stimulation implants 200. As described with reference to FIGS. 5A - 6, the phrenic nerve stimulation implant 1906 can include one or two nerve stimulation implants 504 and can stimulate the phrenic nerve and / or the cervical nerve loop. The CPAP device 1908 is a separate device and not an implantable device. The CPAP device 1908 includes a pump and a mask that is worn on the patient's mouth and nose and is operable to provide continuous positive airway pressure to the patient to assist breathing and help regulate the breathing rate.

[0156] The nerve stimulation implant system 1900 also includes a controller 1902. The controller 1902 can be provided in an external device such as the external devices 302, 510 shown in FIGS. 3A - 6. Alternatively, the controller 1902 can be at least one part of the nerve stimulation implant or can be provided in a computing device that communicates with separate devices, such as nerve stimulation implants 1904, 1906 and a CPAP device 1908.

[0157] The nerve stimulation implant system 1900 also includes a sensor 1910. The sensor 1910 is arranged to detect at least one indicator of sleep apnea. The sensor 1910 can include one or more sensors. In one example, the sensor 1910 is arranged to detect at least one of respiratory rate, heart rate, jaw movement, chest movement, diaphragm movement, oxygen saturation and / or EMG. The sensor 1910 can be provided in one or more of the nerve stimulation implants 1904, 1906 and / or the sensor 1910 can be provided in the CPAP device 1908 and / or the sensor 1910 can be provided in the external devices 302, 510 and / or the sensor 1910 can be a separate sensor attachable to the patient at another location.

[0158] The controller 1902 is set to activate the hypoglossal nerve stimulation implant 1904 and / or the phrenic nerve stimulation implant 1906 and / or the CPAP device 1908 in response to an apnea event detected by the sensor 1910. The controller 1902 can be set to determine whether an apnea event can be classified as OSA, CSA, or a combination of OSA and CSA based on the data provided by the sensor 1910. The controller 1902 can be set to activate one or more of the hypoglossal nerve stimulation implant 1904, the phrenic nerve stimulation implant 1906, and / or the CPAP device 1908 based on the classification of the apnea event.

[0159] For example, when the controller 1902 detects an OSA event, the controller 1902 may be set to activate the hypoglossal nerve stimulation implant 1904 to stimulate the left and / or right genioglossus nerve branches 106. Such stimulation can cause the tongue to protrude and reduce OSA.

[0160] In a further example, when the controller 1902 detects a CSA event, the controller 1902 may be set to activate the phrenic nerve stimulation implant 1906 to stimulate the left phrenic nerve 602 and / or the right phrenic nerve 604 (and / or the cervical nerve loop), as shown in FIG. 6. Such stimulation can reduce CSA.

[0161] In addition or alternatively, when the controller 1902 detects an OSA event, the controller 1902 may be set to activate the CPAP device 1908 to provide positive pressure and adjust the patient's respiratory rate. Such positive pressure can reduce OSA.

[0162] In a further example, when the controller 1902 detects a combined OSA and CSA event, the controller 1902 is set to activate the hypoglossal nerve stimulation implant 1904 to stimulate at least one of the right hypoglossal nerve 402 and the left hypoglossal nerve 404, and also to activate the phrenic nerve stimulation implant 1906 to stimulate at least one of the left phrenic nerve 602 and the right phrenic nerve 604 (and / or the cervical nerve loop). Such combined stimulation can reduce apnea events. In addition or alternatively, the controller 1902 may be set to control the CPAP device 1908 to further provide continuous positive airway pressure to the patient to further reduce apnea events.

[0163] Advantageously, the nerve stimulation implant system 1900 can thereby use information from one or more sensors 1910 to determine the onset or presence of sleep apnea and to determine a classification of sleep apnea (i.e., OSA, CSA, or a combination of OSA and CSA). Thereafter, various forms and combinations of nerve stimulation and positive pressure treatment can be provided to reduce sleep apnea.

[0164] In one example, the treatment provided by the nerve stimulation implant system 1900 can be adjusted with respect to amplitude and / or frequency. In particular, in some examples, the CPAP device 1908 and / or the hypoglossal nerve stimulation implant 1904 and / or the phrenic nerve stimulation implant 1906 can be actuated via a sequenced pulse train, whereby each sequence, pulse train, and (within each pulse train) pulse can be individually adjusted according to a determined treatment. Further, the start time, stop time, and any delay time can be adjusted as needed based on information provided by the sensor 1910. Adjustment of the treatment can be performed manually and / or automatically in response to information provided by the sensor 1910.

[0165] In some examples, the sensor 1910 detects mandibular movement (e.g., rotational movement of the mandible), and the nerve stimulation implant system 1900 sets the treatment provided by the hypoglossal nerve stimulation implant 1904, the phrenic nerve stimulation implant 1906, and / or the CPAP device 1908 based on the detected mandibular movement. In such an example, the sensor 1910 can include a gyroscope and / or an accelerometer and / or a magnetometer, which can be in one or more of the hypoglossal nerve stimulation implant 1904 or the phrenic nerve stimulation implant 1906, and / or in an external device, and / or in a separate sensor unit. The treatment can be set in various periods and / or frequencies and / or amplitudes, and / or durations, and / or various combinations of positive pressure and nerve stimulation based on the detected mandibular movement.

[0166] In some examples, sensor 1910 is arranged to detect other movements, such as chest movement and / or head movement, in the same manner as described above. The treatment can be set in the same manner as described above based on the detected chest and / or head movement, specifically, by adjusting the period, frequency and / or amplitude, and / or duration, and / or various combinations of positive pressure and nerve stimulation based on the detected movement.

[0167] In some examples, sensor 1910 is arranged to detect oxygen saturation and / or EMG. In such examples, the treatment can be set based on the detected oxygen saturation and / or EMG by adjusting the period and / or frequency and / or amplitude, and / or duration, and / or various combinations of positive pressure and nerve stimulation based on the detected oxygen saturation and / or EMG.

[0168] In some examples, sensor 1910 is arranged to detect the patient's respiratory rate, particularly a decrease in the respiratory rate. In such examples, the treatment can be set based on the detected respiratory rate in the same manner as described above. In particular, the treatment can be set with various periods and / or frequencies and / or amplitudes, and / or durations, and / or various combinations of positive pressure and nerve stimulation based on the detected respiratory rate. In some examples, the treatment (specifically, positive pressure and / or nerve stimulation) can be provided in synchronization with the patient's respiratory rate detected by sensor 1910. In one example, the treatment (specifically, positive pressure and / or nerve stimulation) can be provided at a predetermined respiratory rate to adjust the patient's respiratory rate.

[0169] In some examples, the controller 1902 is configured to set the treatment so that the CPAP device 1908 and / or the hypoglossal nerve stimulation implant 1904 and / or the phrenic nerve stimulation implant 1906 operate in a particular phase of the respiratory cycle. For example, one or more may be activated during the inhalation cycle and deactivated during exhalation, or vice versa. In some examples, the controller 1902 is configured so that the hypoglossal nerve stimulation implant 1904 and / or the phrenic nerve stimulation implant 1906 and / or the CPAP device 1908 operate synchronously, either in phase with each other or out of phase with each other. For example, the nerve stimulation may be provided at the start of the inhalation cycle, and the positive pressure may be provided during the inhalation cycle.

[0170] In one example, the sensor 1910 is configured to continuously or intermittently detect one or more parameters of the patient, and the controller 1902 is configured to continuously or intermittently (re)set the treatment provided to the patient. Thereby, a closed-loop system for treating sleep apnea is provided.

[0171] In one example, the controller 1902 may be configured to activate the hypoglossal nerve stimulation implant 1904, the phrenic nerve stimulation implant 1906, and / or the CPAP device 1908 in response to the detected respiratory depression, a depression below a detected respiratory rate threshold, and / or the detection of one or more sleep apnea indicators (e.g., based on the detected respiratory depression and / or jaw, chest, and / or head movement and / or oxygen saturation and / or EMG).

[0172] In the various examples above, the nerve stimulation implant 200 provides nerve stimulation to a nerve, specifically the marginal mandibular branch 106 of the facial nerve and / or the phrenic nerve 502 and / or the cervical nerve loop, based on a stimulation signal generated by a signal generator within the housing 202. The stimulation provided by electrodes 206a, 206b, 206c, 206d of the nerve stimulation implant 200 is based on a stimulation signal generated by a signal generator within the housing 202. The stimulation signal characteristics can be determined by a signal generator within the nerve stimulation implant 200, or they can be determined by an external controller and communicated to the nerve stimulation implant 200.

[0173] The stimulation signal can include random signal generation combining high and low frequencies. The high and low frequency stimulation signals can be generated sequentially or simultaneously. Depending on whether the stimulation is directed at a muscle or a nerve, the stimulation signal can have a frequency in the range of 2 Hz to 1500 Hz. In one example, the stimulation signal can include a low frequency component for stimulating a muscle (e.g., the genioglossus muscle). In such an example, the low frequency component can have a frequency of 2 Hz to 150 Hz. In one example, the stimulation signal can have a high frequency component for stimulating a nerve (e.g., the marginal mandibular branch of the facial nerve). In such an example, the high frequency component can have a frequency of 20 Hz to 1500 Hz.

[0174] In some examples, the stimulation signal has a variable pulse width. The pulse width can be from 20 microseconds to 10,000 microseconds. The pulses can be charge balanced. The stimulation signal can be unipolar, bipolar, or a combination of unipolar and bipolar. The amplitude of the stimulation signal can be up to 10.5 V amplitude and up to 25 mA amplitude.

[0175] In one example, the electrode providing the stimulation signal to the nerve or muscle can operate as an anode or a cathode. The nerve stimulation implant can be controllable to alternate between anode stimulation and cathode stimulation.

[0176] Throughout the description of this specification and the claims, the term "comprising" and its variations mean "including but not limited to", and are not intended to (nor do they) exclude other components, integers or steps. Throughout the description of this specification and the claims, unless the context otherwise requires, singular expressions include pluralities. In particular, when an indefinite article is used, unless the context otherwise requires, this specification is understood to contemplate not only the singular but also the plural.

[0177] Features, integers, characteristics or groups described in connection with a particular aspect, embodiment or example of the invention are understood to be applicable to any other aspect, embodiment or example described herein, unless incompatible therewith. All features disclosed in this specification (including the appended claims, abstract and drawings), and / or all steps of any method or process so disclosed, may be combined in any combination, except combinations where at least some of such features and / or steps are mutually exclusive. The invention is not limited to the details of the above embodiments. The invention extends to any novel one, or any novel combination, of the features disclosed in this specification (including the appended claims, abstract and drawings), or to any novel one, or any novel combination, of the steps of any method or process so disclosed.

Claims

1. An implantable nerve stimulator for treating sleep apnea in a patient, wherein the implantable nerve stimulator operates to stimulate a hypoglossal nerve branch.

2. The implantable nerve stimulator according to claim 1, which operates to stimulate the genioglossal nerve branches and / or the genioglossal muscle.

3. The implantable nerve stimulation implant according to claim 2, which operates to stimulate the genioglossal nerve branch with a first stimulation signal and to stimulate the genioglossal muscle with a second stimulation signal.

4. An implantable nerve stimulator according to Claim 2, which operates to stimulate the genioglossus muscle with a stimulating signal having a frequency of approximately 2 Hz to approximately 150 Hz, for example approximately 2 Hz to approximately 100 Hz, for example approximately 2 Hz to approximately 50 Hz, for example approximately 2 Hz to approximately 40 Hz, for example approximately 2 Hz to approximately 30 Hz, for example approximately 2 Hz to approximately 20 Hz, for example approximately 2 Hz to approximately 15 Hz, for example approximately 2 Hz to approximately 10 Hz.

5. The implantable nerve stimulator according to claim 4, wherein the stimulation signal that stimulates the genioglossus muscle has a peak amplitude of 0.1 mA to 10 mA, for example, 0.1 mA to 5 mA.

6. An implantable nerve stimulator according to Claim 2, which operates to stimulate the genioglossal nerve branch with a stimulating signal having a frequency of approximately 20 Hz to approximately 1500 Hz, for example approximately 20 Hz to approximately 1000 Hz, for example approximately 20 Hz to approximately 500 Hz, for example approximately 20 Hz to approximately 400 Hz, for example approximately 20 Hz to approximately 300 Hz, for example approximately 20 Hz to approximately 200 Hz, for example approximately 20 Hz to approximately 150 Hz, for example approximately 20 Hz to approximately 100 Hz.

7. The implantable nerve stimulator according to claim 2, wherein stimulation of the genioglossal nerve branches and / or genioglossal muscle includes a stimulation signal having multiple pulses, each pulse having a pulse width of 30 microseconds to 2,000 microseconds.

8. The implantable nerve stimulation implant according to claim 2, comprising an electrode lead having an electrode, wherein the electrode lead is implanted in the genioglossus muscle proximal to a genioglossus nerve branch of the patient.

9. The implantable nerve stimulator according to claim 8, further comprising a housing portion, wherein electrode leads extend from the housing portion, and the housing portion is implanted in the subcutaneous tissue of a patient.

10. The implantable nerve stimulator according to claim 1, wherein wireless power is transmitted from an external device to the implantable nerve stimulator.

11. The implantable nerve stimulator according to claim 10, wherein the wireless power transmitted to the implantable nerve stimulator includes frequencies of 300 MHz to 3 GHz, for example 400 MHz to 2.5 GHz, for example 433 MHz to 2.4 GHz.

12. At least one physiological parameter, for example, Patient's respiratory rate, Patient electromyography (EMG), Patient's electrocardiogram (ECG), Patient's oxygen saturation, Patient's body temperature, Patient's heart rate, Patient's blood pressure An implantable nerve stimulator according to claim 1, used in combination with a sensor that detects at least one of the following.

13. At least one movement of the patient, for example, Patient's respiratory movements, Patient's mandibular movement, Patient's chest movements, Patient's diaphragmatic movement An implantable nerve stimulator according to claim 1, used in combination with a sensor that detects at least one of the following.

14. Physiological parameters or movements of a patient exhibiting sleep apnea, for example, Decreased respiratory rate, Electromyography (EMG) profile indicating sleep apnea, Electrocardiogram (ECG) profile indicating sleep apnea, Decreased oxygen saturation, Rising body temperature, Increased heart rate, Increased blood pressure, or Respiratory movements, mandibular movements, chest movements, or diaphragmatic movements An implantable nerve stimulator according to claim 1, used in combination with a sensor that detects at least one of the following.

15. An implantable nerve stimulator according to any one of claims 12 to 14, which is controlled to stimulate the genioglossal nerve branch and / or the genioglossal muscle in response to at least one physiological parameter of the detected patient and / or at least one movement of the detected patient.

16. An implantable nerve stimulator according to any one of claims 12 to 14, wherein a sensor detects the patient's respiratory rate and acts to stimulate the genioglossal nerve branches and / or genioglossal muscle in synchronization with the detected respiratory rate.

17. An implantable nerve stimulator according to claim 16, which operates to stimulate the genioglossal nerve branches and / or the genioglossal muscle at the start of the patient's inspiratory cycle.

18. An implantable nerve stimulator according to any one of claims 12 to 14, which determines the classification of sleep apnea from at least one detected physiological parameter and / or at least one patient movement, and in particular determines whether the detected sleep apnea includes obstructive sleep apnea (OSA), central sleep apnea (CSA), or a combination of OSA and CSA.

19. The implantable nerve stimulator according to claim 18, used in combination with a second implantable nerve stimulator that operates to stimulate the phrenic nerve and / or cervical nerve loop of a patient.

20. An implantable nerve stimulator according to claim 18, to be used in combination with a continuous positive airway pressure (CPAP) device that operates to provide positive pressure to a patient's airway.

21. An implantable nerve stimulator according to claim 19, which is controlled based on at least one physiological parameter of the detected patient and / or at least one movement of the detected patient.

22. An implantable nerve stimulator according to claim 18, which operates based on the determined classification of sleep apnea.

23. The implantable nerve stimulator according to claim 22, which is used in combination with a nerve stimulator that operates to stimulate the genioglossal nerve branches and / or the genioglossal muscle, if the sleep apnea is classified as obstructive sleep apnea (OSA).

24. The implantable nerve stimulator according to claim 22, which is used in combination with a second nerve stimulator that operates to stimulate the phrenic nerve and / or cervical nerve loop if the sleep apnea is determined to be classified as central sleep apnea (CSA).

25. An implantable nerve stimulator according to claim 22, which is used in combination with a CPAP device that operates to provide positive pressure to a patient if the sleep apnea is classified as obstructive sleep apnea (OSA).

26. If the sleep apnea is classified as a combination of obstructive sleep apnea and central sleep apnea, (i) A nerve stimulator that operates to stimulate the genioglossal nerve branches and the genioglossal muscle; and (ii) A second nerve stimulation implant that acts to stimulate the phrenic nerve and / or cervical nerve loop, and CPAP devices that operate to provide positive pressure to the patient. at least one of the following; An implantable nerve stimulator according to claim 22, used in combination with the above.

27. An implantable nerve stimulation implant according to any one of claims 12 to 14, wherein the sensor is integrated with the nerve stimulation implant.

28. A system for treating sleep apnea in patients, A nerve stimulating implant that can be implanted proximal to a hypoglossal nerve branch in a patient, and which is operable to stimulate the hypoglossal nerve branch, including the nerve stimulating implant, The aforementioned system.

29. The system according to claim 28, wherein an implantable nerve stimulator is operable to stimulate the patient's genioglossal nerve branches and / or genioglossal muscle.

30. The system according to claim 29, wherein the nerve stimulation implant comprises an electrode implantable in the genioglossus muscle proximal to a branch of the patient's genioglossus nerve, and a signal generator for generating a stimulation signal to stimulate the patient's genioglossus nerve branch and / or genioglossus muscle.

31. The system according to claim 29, wherein the nerve stimulation implant is a battery-less implant and includes a wireless power receiver.

32. The system according to claim 31, further comprising an external device including a wireless power transmitter for transmitting wireless power to a nerve stimulation implant when the nerve stimulation implant is implanted in the genioglossus muscle.

33. The system according to claim 28, further comprising sensors arranged to detect at least one physiological parameter of a patient and / or at least one movement of a patient.

34. At least one physiological parameter, Patient's respiratory rate, Patient electromyography (EMG), Patient's electrocardiogram (ECG), Patient's oxygen saturation, Patient's body temperature, Patient's heart rate, Patient's blood pressure The system according to claim 33, comprising one or more of the above.

35. At least one of the patient's movements, Patient's respiratory movements, Patient's mandibular movement, Patient's chest movements, Patient's diaphragmatic movement The system according to claim 33, comprising at least one of the following.

36. Detected physiological parameters and / or detected patient movements, for example, Decreased respiratory rate, Electromyography (EMG) profile indicating sleep apnea, Electrocardiogram (ECG) profile indicating sleep apnea, Decreased oxygen saturation, Rising body temperature, Increased heart rate, Increased blood pressure, or Respiratory movements, mandibular movements, chest movements, or diaphragmatic movements The system according to claim 33, further comprising a controller set up to determine the onset or occurrence of sleep apnea based on at least one of the following.

37. The system according to claim 28, further comprising a second nerve stimulation implant that can be implanted to stimulate the patient's phrenic nerve and / or cervical nerve loop.

38. The system according to claim 28, further comprising a continuous positive airway pressure (CPAP) device that can be activated to provide positive pressure to a patient.

39. The system according to any one of claims 33 to 38, further comprising the nerve stimulation implant or a controller configured to control each nerve stimulation implant and optionally a CPAP device based on at least one physiological parameter of the detected patient and / or at least one movement of the detected patient.

40. The system according to any one of claims 33 to 38, wherein the controller is set up to determine the classification of sleep apnea based on at least one detected physiological parameter and / or at least one movement of the patient, in particular to determine whether the detected sleep apnea includes obstructive sleep apnea (OSA), central sleep apnea (CSA), or a combination of OSA and CSA.

41. The system according to claim 40, wherein the controller is configured to activate a neurostimulation implant and / or a second neurostimulation implant and / or a CPAP device based on the determined sleep apnea classification.

42. A nerve stimulation implant for treating sleep apnea, The nerve stimulation implant includes a housing portion and a flexible, elongated electrode lead extending from the housing portion and having an electrode. The nerve stimulation implant, (i) A delivery device having a first needle for holding the housing portion of a nerve stimulation implant and a second needle for holding an electrode lead, The second needle has a higher gauge than the first needle. The second needle extends beyond the first needle, and, The second needle can be retracted in the direction toward the first needle. To provide the aforementioned delivery device; (ii) Inserting a second needle into the patient at the insertion point under the patient's jaw; (iii) Advancing the second needle through the patient's tissue toward the patient's genioglossus muscle along the direction of insertion; (iv) When the second needle is in the patient's genioglossus muscle, retract the second needle and implant an electrode lead with an electrode proximal to a genioglossus nerve branch within the genioglossus muscle; and (v) A device implanted in a patient by a method including discharging the housing from the first needle and implanting the housing under the skin, The aforementioned nerve stimulation implant.

43. The nerve stimulation implant according to claim 42, wherein the insertion point is located proximal to the posterior edge of the mandibular junction of the patient.

44. The nerve stimulation implant according to claim 42, wherein the insertion direction includes a first angle (β) in the mandibular plane of the patient's jaw and a second angle (θ) in the sagittal plane of the patient.

45. The nerve stimulation implant according to claim 44, wherein the first angle (β) is approximately ±15 degrees to approximately ±30 degrees, for example, approximately ±18 degrees to approximately ±25 degrees, for example, approximately ±20 degrees to approximately ±23 degrees, for example, approximately ±22 degrees, and particularly approximately ±21.8 degrees.

46. The nerve stimulation implant according to claim 44, wherein the second angle is approximately 40 degrees to approximately 65 degrees, for example approximately 45 degrees to approximately 55 degrees, for example approximately 40 degrees to approximately 50 degrees, for example approximately 47 degrees to approximately 49 degrees, and particularly approximately 48.1 degrees.

47. The nerve stimulation implant according to claim 44, wherein the method comprises scanning a patient and determining the insertion direction based on the scan.

48. The nerve stimulation implant according to claim 42, further comprising rotating the delivery device before ejecting the housing portion from the first needle such that the housing portion is implanted in different directions relative to the electrode lead.

49. The nerve stimulation implant according to claim 48, wherein the delivery device is rotated toward a position in which the first needle is parallel to the skin surface, and the tip of the first needle is positioned beneath the skin.

50. The nerve stimulation implant according to claim 48, wherein the electrode lead bends by rotating the delivery device.

51. The nerve stimulation implant according to claim 50, wherein the first needle includes a slot, and a portion of the electrode lead passes through the slot when the delivery device is rotated.

52. The nerve stimulation implant according to claim 42, further comprising using an ultrasonic device for monitoring the position of a second needle.

53. The nerve stimulation implant according to any one of claims 42 to 52, wherein the method further comprises positioning a guide on a patient, the guide having a guide channel defining the direction of insertion of a second needle, and positioning the second needle in the guide channel.

54. The nerve stimulation implant according to claim 53, further comprising removing the guide while the second needle is positioned percutaneously.

55. Nerve stimulation implants containing electrodes; A delivery device for implanting a nerve stimulation implant so that the electrode is implanted in the patient's genioglossus muscle proximal to the genioglossus nerve branch; and A patient-placeable guide, which includes a guide channel configured to receive a portion of a delivery device and which determines the insertion direction of the delivery device for implanting a nerve stimulation implant in the genioglossus muscle in proximity to the genioglossus nerve branch, A sleep apnea treatment system, including [mention specific component / feature].

56. A nerve stimulation implant includes a housing and a flexible, elongated electrode lead extending from the housing. The delivery device includes a first needle adapted for holding the housing portion of a nerve stimulation implant and a second needle adapted for holding an electrode lead, wherein the second needle has a higher gauge than the first needle and extends beyond the first needle. A sleep apnea treatment system according to claim 55.

57. The sleep apnea treatment system according to claim 56, wherein a second needle is retractable toward the first needle for implanting an electrode lead.

58. The sleep apnea treatment system according to claim 55, wherein the guide channel is movable to align the guide channel with the patient's insertion point.

59. The sleep apnea treatment system according to claim 55, wherein the guide channel is rotatable to change the insertion direction.

60. The sleep apnea treatment system according to claim 55, wherein the guide further includes an attachment for an ultrasound scanner.

61. The sleep apnea treatment system according to claim 55, wherein the guide channel includes a slot for removing the guide while the delivery device is implanted percutaneously.

62. A sleep apnea treatment system according to any one of claims 55 to 61, wherein the guide includes a positioning portion that can be positioned relative to the patient.

63. The sleep apnea treatment system according to claim 62, wherein a positioning portion is formed to be positioned on the patient's jaw.

64. The sleep apnea treatment system according to claim 62, wherein the positioning portion is formed to be received in the patient's mouth.

65. The sleep apnea treatment system according to claim 62, wherein the positioning portion is configured to bite into the patient's lower jaw.

66. A sleep apnea treatment system according to claim 63, comprising a brace configured such that a positioning portion interlocks with the patient's lower jaw and neck.

67. A guide for a delivery device for percutaneous implantation of a nerve stimulation implant in the patient's genioglossus muscle proximal to the genioglossus nerve branch, Positioning portion that can be placed relative to the patient; and A guide channel configured to receive a portion of a delivery device, the guide channel determining the insertion direction of the delivery device for implanting a nerve stimulation implant in the genioglossus muscle in proximity to the genioglossus nerve branch. The aforementioned guide, including.

68. The guide according to claim 67, wherein the delivery device comprises a first needle adapted for holding the housing portion of a nerve stimulation implant and a second needle adapted for holding an electrode lead, wherein the guide channel is configured for receiving the second needle.

69. The guide according to claim 67, wherein the guide channel is movable to align the guide channel with the patient's insertion point.

70. The guide according to claim 67, wherein the guide channel is rotatable to change the insertion direction.

71. The guide according to claim 67, further comprising an attachment for an ultrasonic scanner.

72. The guide according to claim 67, wherein the guide channel includes a slot for removing the guide while the delivery device is implanted percutaneously.

73. The guide according to claim 67, wherein the positioning portion is formed to be positioned on the patient's jaw.

74. The guide according to claim 67, wherein the positioning portion is formed to be received in the mouth of a patient.

75. The guide according to any one of claims 67 to 74, wherein the positioning portion is configured to bite into the patient's lower jaw.

76. The guide according to claim 75, comprising a brace whose positioning portion is configured to interlock with the patient's lower jaw and neck.

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