Abstract: A medical system includes a shaft having a proximal end and a distal end, a balloon attached to the distal end of the shaft, the balloon movable between an expanded state and a deflated state where a maximum diameter of the balloon is greater in the expanded state than in the deflated state, and an electrode is attached to the shaft where a portion of the balloon includes a plurality of apertures fluidly connecting an interior of the balloon to an exterior of the balloon.

Abstract: An example medical device includes a plurality of electrodes, therapy delivery circuitry, and processing circuitry configured to control the therapy delivery circuitry to deliver electrical stimulation to an intercostal nerve of a patient via at least two of the plurality of electrodes, wherein the electrical stimulation is delivered with stimulation parameters configured to suppress ventricular tachyarrhythmia of the patient, wherein the stimulation parameters comprise a stimulation frequency less than or equal to 40 hertz (Hz).

Abstract: A system includes a collar that is worn around a neck of the user. A stimulator is coupled to the collar such that the stimulator is positioned adjacent to an airway of the user. The sensor is coupled to the collar and configured to generate data associated with the airway of the user. The memory is coupled to the collar and storing machine-readable instructions. The control system is coupled to the collar and includes one or more processors configured to execute the machine-readable instructions to determine, based at least on an analysis of the generated data, that the user is currently experiencing an apnea event. In response to the determination, the control system causes the stimulator to provide electrical stimulation, at a first intensity level, to one or more muscles of the user that are adjacent to the airway to aid in stopping the apnea event.

Abstract: Methods, devices, and systems are disclosed for controlled delivery of a therapy, such as a stimulant, to a mouth of a subject via an oral device positioned in a secured configuration in the mouth. At least one of a tongue position stimulator (TST) and tongue position sensor (TSE) is provided, according to certain aspects. According to another aspect, a stimulus is delivered to the mouth and/or tongue via a mouthpiece secured to the subject's teeth. In another regard, a stimulus is delivered that generates a natural response to eliminate or reduce sleep disorders, such as for example at least one of snoring and obstructive sleep apnea.

Abstract: At least some embodiments of the present disclosure are directed to systems and methods for managing sleep disordered breathing (e.g., obstructive sleep apnea) for a patient. A first implantable electrode delivers a first stimulation signal proximate to a first nerve of the patient to stimulate the first nerve and activate at least one first muscle for an upper airway dilation of the person. A second implantable electrode delivers a second stimulation signal proximate to a second nerve to stimulate the second nerve and activate at least one second muscle for a caudal tracheal traction for an upper airway of the person. A stimulation signal generator generates the first and second stimulation signals and coordinates the delivery of the first stimulation signal with the delivery of the second stimulation signal.

Abstract: A method of implanting includes inserting a stimulation element into a head-and-neck region and positioning an electrode array of the stimulation element relative to a target portion of a nerve.

Abstract: A neuromodulation system is provided herein. The system can include a cuff electrode, an electronics package, which can be part of a neuromodulation device; an external controller; a sensor; and a computing device. The neuromodulation device can include an antenna including an upper and a lower coil electrically connected to each other in parallel. The computing device can execute a closed-loop algorithm based on physiological sensed data relating to sleep.

Abstract: This disclosure describes, among other embodiments, systems and related methods for selecting electrode combinations to be used during nerve pacing procedures. A first set of electrode combinations of a nerve pacing system, such as a phrenic nerve pacing system for diaphragm activation, may be mapped (or tested) to determine the location of the electrode combinations relative to a target nerve. Once the general location of the target nerve is known, a more localized second set of electrode combinations may be tested to determine the most suitable electrode combinations for nerve stimulation. At various stages of the mapping process, electrode combinations that are non-optimal may be discarded as candidates for use in a nerve pacing procedure. The systems and methods described herein may allow for the selection of electrode combinations that are most suitable for stimulation of the left and right phrenic nerves during diaphragm pacing.

Abstract: Modulation of neural activity of a ganglion, by applying a signal to a sympathetic nerve adjacent to the ganglion, results in preferential reduction of sympathetic signals to an effector, thereby providing ways of treating and preventing conditions associated with exacerbated sympatho-excitation.

Abstract: A method for treating sleep disordered breathing includes electrically stimulating an upper airway patency-related nerve via implantable stimulation elements.

Abstract: Described herein are methods of treating a tissue using a treatment tip apparatus (e.g., devices, systems, etc.) including one, or more preferably a plurality, of electrodes that are protected by an electrode partition, such as an electrode housing (which may be retractable) until pressed against the tissue for deployment of the electrodes and delivery of a therapeutic treatment. In particular, these methods may include the use of a plurality of treatment electrodes (e.g., needle electrodes) and in some examples may include for the delivery of nanosecond pulsed electric fields.

Abstract: Implementations described and claimed herein provide paddle leads for dorsal root ganglia (DRG) stimulation and methods of implanting the same. In one implementation, the paddle lead has a small profile facilitating deployment into a target space in the neuroforamen dorsal to the DRG and below the vertebral lamina. A paddle body of the paddle lead may include a living hinge and/or a contoured profile to further facilitate implantation in the target space. For suture assisted deployment as well as to resist migration of the paddle lead once deployed, the paddle lead may include a suture loop configuration. The paddle lead further includes an electrode array having electrode contacts arranged in a two dimensional configuration pattern to create an electrical field optimized for stimulation of the DRG.

Abstract: Methods and systems of treating sleep disordered breathing in a patient suffering therefrom by activating one or more infrahyoid strap muscles are provided. Activation of one or more infrahyoid muscles can be accomplished by stimulating an ansa cervicalis, including one or both of the superior root and the inferior root of the ansa cervicalis, alone or in combination with stimulating the hypoglossal nerve.

Abstract: A method for subcutaneously treating pain in a patient includes first providing a neurostimulator with an IPG body and at least a primary, a secondary, and a tertiary integral lead with electrodes disposed thereon. A primary incision is opened to expose the subcutaneous region below the dermis in a selected portion of the body. A pocket is then opened for the IPG through the primary incision and the integral leads are inserted through the primary incision and routed subcutaneously to desired nerve regions along desired paths. The IPG is disposed in the pocket through the primary incision. The primary incision is then closed and the IPG and the electrodes activated to provide localized stimulation to the desired nerve regions and at least three of the nerves associated therewith to achieve a desired pain reduction response from the patient.

Abstract: A method for treatment of a headache disorder in a human subject, including selecting at least one treatment area in the nasal cavity of the human subject, said treatment area being selected from a posterior part of the nasal cavity or an anterior part of the nasal cavity, providing a device including a stimulation member arranged for vibration stimulation of the selected treatment area, and at least one expansion member provided with a channel having a plurality of openings arranged for fluid communication with the stimulation member, introducing the stimulation member into a nasal cavity of the human subject, expanding the stimulation member to a volume such that the stimulation member abuts against the tissue to exert a pressure on tissue of the selected treatment area and bringing the stimulation member to vibrate in the nasal cavity to impart vibrations to the selected treatment area, wherein the vibrations are imparted to a posterior part of the nasal cavity, to an anterior part of the nasal cavity, seq

Abstract: An implantable neurostimulator (INS) and method of use, the INS including an electrical lead having formed thereon at least a pair of bi-polar electrodes, wherein the electrical lead is configured for placement of the pair of bi-polar electrodes proximate protrusor muscles of a patient, a pulse generator electrically connected to the electrical lead and configured to deliver electrical energy to the pair of bi-polar electrodes, the pulse generator having mounted therein a sensor and a control circuit, and the sensor is configured to generate signals representative of an orientation of the pulse generator and communicate the signals to the control circuit and the control circuit is configured to determine the orientation of the pulse generator and deliver electrical energy to the bi-polar electrodes when the determined orientation correlates to a pre-determined orientation.

Abstract: A therapeutic device comprises a sensor positioned proximate to a user and configured to receive a plurality of signals, and a processor coupled to the sensor and configured to determine a biomarker describing a biological characteristic of the user based on the plurality of signals, and determine whether the user is likely to experience an impending sleep disorder episode within a predetermined period of time based on the biomarker.

Abstract: An appliance includes an external communication port, such as an RJ45 port, and a wireless communication module in wireless communication with a remote server through an external network. In addition, a controller includes a boot loader segment and is configured to receive a request to access the boot loader segment of the controller, transmit a notification of the request to the remote server using the wireless communication module, receive an access determination from the remote server, e.g., such as an access authorization or denial from an owner, and regulate access to the boot loader segment based at least in part on the access determination.

Abstract: The present technology is generally directed to systems and methods for addressing a patient's sleep apnea. At least some embodiments include an electrode array and a controller. The electrode array can include one or more electrodes and can be configured to be implanted at least proximate to a target tissue of the patient in an orientation, with at least a vector component of the orientation aligned along an inferior-superior axis of the patient. The controller can be communicatively coupled to the electrode array and include one or more non-transitory, computer-readable media having instructions that, when executed by one or more processors of the controller, cause the controller to direct an electrical signal to be delivered by the electrode array to the target tissue.

Abstract: Provided is an intraesophageal electrostimulator configured so that other medical tools can also be easily inserted into an esophagus and misalignment in the esophagus can be reduced. An intraesophageal electrostimulator 100 includes a stimulator body 101, stimulating electrodes 111, 112, and power feed lines 113, 114. The stimulator body 101 is formed, in order to insert the stimulator body 101 into an esophagus S, in an elongated flat plate shape with flexibility in a longitudinal direction. The stimulator body 101 includes a first flat plate member 102, a second flat plate member 103, and an exterior body 104. On one plate surface of the first flat plate member 102, each of the stimulating electrodes 111, 112 is provided so as to protrude from the plate surface. The second flat plate member 103 overlaps with the other plate surface of the first flat plate member 102 such that the second flat plate member 103 and the first flat plate member 102 sandwich the power feed lines 113, 114.

Abstract: An extravascular neural interface includes a device containing electrodes for neurostimulation of a vessel. The devices are housed in flexible substrates forming two flaps, an inner flap having a spinal portion for routing leads/conductors into the device for connection to the electrodes and an outer flap that overlaps the inner flap. The inner flap supports and positions the electrodes to be inward facing, i.e., extravascular designs. The electrodes may be circular or elliptical and include a plurality of wings for securing the electrodes within a flap.

Abstract: A system and method for determining parameters of stimulation electrical signals for vagus nerve stimulation is discussed. Initial parameters of the signals are selected to provide reliable response to stimulation in physiological measurements of a subject. One or more physiological and neurological indices are determined based on a vagus nerve response model. For a selected vagus nerve activation, the electrical parameters of the signals are varied while monitoring changes in physiological parameters and values of the indices. The electrical parameters are varied until desired response in the physiological measurements and the values of the indices is observed. The electrical parameters are then stored as preferred parameters and can be used to activate the selected vagus nerve of the subject.

Abstract: An automated external defibrillator (210) for use during CPR comprising: a first electrode pad (370a) configured to obtain an electrocardiogram (ECG) signal from an individual; a second electrode pad (370b) configured to obtain ECG signal from the individual, wherein the first and/or the second electrode pad comprises an electrode pad visual display (372) configured to be visible while providing CPR to the individual; a controller (310) configured to: (i) process an electrical and/or an accelerometer signal to determine a depth of one or more chest compressions during CPR; (ii) compare the determined depth of the chest compressions to a threshold depth; (ii) determine, based on the comparison, that the determined depth exceeds or falls below the threshold depth; and (iii) direct the electrode pad visual display to provide a depth indication to the user that the determined depth of the chest compressions exceeds or falls below the threshold depth.

Abstract: Stimulation and recording electrode assemblies that are particularly useful for Automatic Period Stimulation (APS). Such embodiments are compatible with nerve monitoring systems to provide continuous stimulation of a nerve during surgery. Certain embodiments include an electrode assembly having cuff including a body and two ears extending from the body. Within the body, at least one electrode is supported and connected to a lead wire assembly. The ears can be brought together to enlarge a gap in the body so that the electrode assembly can be fixated around a nerve. Other embodiments include an electrode assembly including first and second needle electrodes that each have a tip. A body is provided to interconnect the needle electrodes and can be manipulated to move the tips either toward or away from one another. Disclosed embodiments provide nerve monitoring and stimulation in cases where the nerve is only partially dissected.

Abstract: A method for detecting a respiratory event of a subject comprises: receiving a bio-impedance measurement signal (S2) dependent on respiratory action from the subject; extracting (306) at least one time-sequence of the bio-impedance measurement signal (S2); and for each extracted time-sequence: comparing (308) the bio-impedance measurement signal (S2) with each of a plurality of machine learning models in an ensemble of machine learning models to form a set of predictions of occurrence of a respiratory event, wherein each prediction is based on comparing the bio-impedance measurement signal (S2) with one machine learning model, wherein each model correlates features of time-sequences of a bio-impedance measurement signal (S2) with presence of a respiratory event and wherein each model is trained on a unique data set of training time-sequences; deciding (310) whether a respiratory event occurs in the extracted time-sequence based on the set of predictions.

Abstract: An example of a system for assisting a rescuer in providing CPR includes a motion sensor configured to generate signals indicative of chest motion during CPR chest compressions, and a defibrillator including a display screen configured to provide CPR feedback and defibrillation information and a processor configured to receive the signals, generate a compression waveform based on the signals, detect, in the compression waveform, features characteristic of chest compressions, compare the detected features to a predetermined criterion that distinguishes between manually delivered and compressions delivered by an automated compression device, and selectively provide the CPR feedback based on whether the compressions are the manually delivered or the automated compressions, where the selective provision of the CPR feedback includes displaying CPR parameters for the manually delivered compressions, and a removing from the display screen at least one CPR parameter of the CPR parameters for the automated compression

Abstract: Implantable electrodes with power delivery wearable for treating sleep apnea, and associated systems and methods are disclosed herein. A representative system includes non-implantable signal generator worn by the patient and having an antenna that directs a mid-field RF power signal to an implanted electrode. The implanted electrode in turn directs a lower frequency signal to a neural target, for example, the patient's hypoglossal nerve. Representative signal generators can have the form of a mouthpiece, a collar or other wearable, and/or a skin-mounted patch.

Abstract: A means for treating breathing disorders by stimulating respiratory muscles or nerves to entrain respiratory systems while leaving respiratory drive intact. Embodiments of the invention employ frequency analysis to determine if appropriate stimulation energy is being applied.

Abstract: An example method includes receiving one or more physiological signals; detecting an apnea event based on the one or more physiological signals; determining that the apnea event cannot be characterized as one of a normal, OSA (obstructive sleep apnea), CSA (central sleep apnea), or combination OSA/CSA event; and outputting an electrical stimulation as a default based on determining that the apnea event cannot be characterized as a normal event, an OSA event, a CSA event, or combination OSA/CSA events.

Abstract: A method for treating a heart failure patient by ablating a nerve of the splanchnic sympathetic nervous system to increase venous capacitance and reduce pulmonary blood pressure. A method including: inserting a catheter into a vein adjacent the nerve, applying stimulation energy and observing hemodynamic effects, applying ablation energy and observing hemodynamic effects, applying simulation energy after the ablation and observing hemodynamic effects.

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

Abstract: A device for treating sleep disordered breathing includes a stimulation element to stimulate an airway patency related nerve.

Abstract: An ear-piece assembly includes (i) an antenna portion enclosing a transmitting antenna configured to send one or more input signals containing electrical energy to a passive implantable neural stimulator device such that the passive implantable neural stimulator generates one or more stimulation pulses suitable for stimulating a neural structure in the craniofacial region solely using the electrical energy in the input signals; and (ii) an enclosure coupled to the antenna portion, wherein enclosure is sized and shaped to be mounted on a helix portion of an ear such that, when worn by a patient, weight from the enclosure is distributed over the helix portion of the ear for the enclosure to rest thereon, wherein the enclosure comprises (i) a controller module configured to provide the one or more input signals to the transmitting antenna, and (ii) a battery adapted to provide energy to the ear-piece assembly.

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

Abstract: A system and method for treating sleep apnea includes inserting an implantable pulse generator subcutaneously within a body of a patient and connecting a lead to the pulse generator. The lead is inserted within the vasculature and advanced transvenously through the vasculature until a stimulation portion of the lead becomes positioned in close proximity to the hypoglossal nerve. A nerve-stimulation signal is applied to the hypoglossal nerve via the stimulation portion of the lead.

Abstract: A device for treating sleep disordered breathing includes a stimulation element to stimulate an airway-patency-related nerve.

Abstract: An oral appliance for treating sleep apnea in a user includes a mouthpiece configured for being positioned in an oral cavity of the user, and at least one pulse oximeter attached to the mouthpiece. According to an aspect, the pulse oximeter is configured to monitor actual oxygen saturation levels of hemoglobin of the user when the oral appliance is positioned in the oral cavity of the user. The oral appliance may include an additional sensor attached to the mouthpiece that includes at least one of an airflow sensor, a pressure sensor, a noise detector, and an actigraphy sensor.

Abstract: A method comprises establishing communication between a therapy device implantable in a patient and a consumer electronic device operable by the patient. The method comprises controlling, by the consumer electronic device, a predetermined set of therapy device functions in response to patient inputs to the consumer electronic device. The method also comprises transmitting therapy data from the therapy device to the consumer electronic device. The method further comprises presenting therapy data on a display of the consumer electronic device.

Abstract: The present technology relates to the field of medical monitoring, and, in particular, to non-contact detecting and monitoring of patient breathing. Systems, methods, and computer readable media are described for calculating a change in depth of a region of interest (ROI) on a patient. In some embodiments, the systems, methods, and/or computer readable media can identify steep changes in depths. For example, the systems, methods, and/or computer readable media can identify large, inaccurate changes in depths that can occur at edge regions of a patient. In these and other embodiments, the systems, methods, and/or computer readable media can adjust the identified steep changes in depth before determining one or more patient respiratory parameters.

Abstract: An apparatus includes an implantable stimulator to treat sleep disordered breathing (SDB) and at least one electrode associated with the stimulator. The apparatus includes a therapy device arranged to be implanted within a head/neck region of a patient. The therapy device includes a microstimulator including a housing to encapsulate at least stimulation circuitry, a rechargeable power element, and a control portion including a therapy manager to control the stimulation circuitry.

Abstract: An apparatus and method for treating obstructive sleep apnea includes a pulse oximeter, a source of transcutaneous electrical stimulation having a pair of electrodes for delivering TES to a person, and a controller. The electrodes are adapted to be applied to the person's skin adjacent the person's upper airway to stimulate one or more nerves or muscles in the upper airway when TES is applied to the electrodes. The controller is adapted to receive blood oxygen data from the pulse oximeter and is programmed to apply TES when the blood oxygen indicates that the person's blood oxygen is below a predetermined threshold, so as to increase a resting tone of the person's tongue.

Abstract: The present disclosure is in the field of sleep and respiratory care. In particular, the present disclosure provides means and methods for decreasing the respiratory effort of a sleeping subject. The present disclosure also provides means and methods for treating the snoring of a sleeping subject.

Abstract: Systems and methods for a neuromodulation system are provided. In one example, the neuromodulation system includes a stimulation element, a stimulation controller, and a stimulation feedback acquisition system that includes a reference trigger input module configured such that the temporal relationship between a provided stimulation via the stimulation element and the stimulation controller, and a stimulation response received by the stimulation feedback acquisition system can be characterized.

Abstract: A positive airway pressure apparatus is automatically adjusting. Pressure increases in response to apnea events when the apparatus is in one or more responsive states. Pressure does not increase in response to apnea events when the apparatus is in a non-responsive state. The apparatus switches between responsive and nonresponsive states depending upon any of a number of different criteria that help differentiate between open airway apnea events and closed airway apnea events.

Abstract: A trans mucosal neuromuscular electrical stimulation device including a mouthpiece, electrodes associated with the mouthpiece. The device and/or mouthpiece incorporates electrical circuitry operatively connecting to the electrodes to a power source and is configured to provide, in use, electrical stimulation to one or more palate and/or tongue muscles via the electrodes through the oral mucosa. The treatment regime, including the location of stimulation and the parameters used, is designed to increase resting muscle tone and/or muscle tone during sleep.

Abstract: A wearable device for sensing vital signs includes a housing defining an interior cavity. An optical unit is positioned inside the interior cavity. The optical unit includes one or more light emitters that emit optical signals, at least one polarizer orientated to block optical signals having a predetermined polarity direction, and one or more light sensors that receive optical signals that pass through the at least one polarizer. An acoustic unit is positioned inside the interior cavity, and has a microphone to receive acoustic signals that enter into the interior cavity. The acoustic signals are used to non-invasively estimate blood pressure.

Abstract: Approaches to determining a sleep fitness score for a user are provided, such as may be based upon monitored breathing disturbances of a user. The system receives user state data generated over a time period by a combination of sensors provided via a wearable tracker associated with the user. A system can use this information to calculate a sleep fitness score, breathing disturbance score, or other such value. The system can classify every minute within the time period as either normal or atypical, for example, and may provide such information for presentation to the user.

Abstract: Maxillary devices and Mandibular devices each have a first housing connectable to a tooth of a user or connectable or integral with a teeth covering, wherein the housing encloses an on-board circuit board and a power source. The first housing of the maxillary devices has a tooth connecting portion, a palate housing portion and/or a buccal housing portion. The first housing of the mandibular devices has a tooth connecting portion and a sublingual portion. Each of the palate housing portion and the buccal housing portion enclose a stimulator having an electrode electrically connected to the on-board circuit board and the power source, and can enclose a sensor and/or a medicament dispenser. The sublingual portion encloses a sensor and a medicament dispenser each of which are in electrical communication with the microprocessor of the on-board circuit board.

Abstract: A method of detecting sleep apnea includes generating a cardiac signal indicating activity of a heart of a patient. The method further includes determining a short-term average heart rate and a long-term average heart rate. The method further includes determining a start and end of a heart rate cycle based on the short-term average heart rate and the long-term average heart rate. The method further includes determining physiological parameter values occurring during the heart rate cycle. The method further includes determining whether patient has or has not experienced a sleep apnea event based on whether one or more conditions are satisfied by one or more parameter values for one or more heart rate cycles and responsively generating an indication that patient has or has not experienced a sleep apnea event.

Abstract: Hemodynamic performance of a heart may be improved by determining, from a location associated with a diaphragm, an occurrence of a valid cardiac event; and then delivering asymptomatic electrical stimulation therapy directly to the diaphragm at termination of a diaphragmatic stimulation delay period that is timed relative to the occurrence of the valid cardiac event. The diaphragmatic stimulation delay period may be automatically established by sensing a plurality of cardiac events directly from a diaphragm; and for each of the sensed cardia events, determining whether the sensed cardiac event represents a valid cardiac event or a non-valid cardiac event. The diaphragmatic stimulation delay period is then calculated based on a plurality of sensed cardia events that are determined to be valid.