Abstract: An insulative body of a medical electrical lead electrode assembly includes a pre-formed channel having a section extending at an angle to a longitudinal axis of the body. An electrode portion of a conductive component has an electrode contact surface facing outward from a first side of the body and a coupling portion embedded in the body. A conductor, which is coupled to the coupling portion of the component, is disposed in the channel.

Abstract: Devices, systems and methods of neurostimulation for treating obstructive sleep apnea. The system is adapted to send an electrical signal from an implanted neurostimulator through a stimulation lead to a patient's nerve at an appropriate phase of the respiratory cycle based on input from a respiration sensing lead. External components are adapted for wireless communication with the neurostimulator. The neurostimulator is adapted to deliver therapeutic stimulation based on inputs.

Abstract: A method of providing a sleep apnea nerve stimulation therapy to a subject may include detecting a respiratory waveform of the subject with a sensor. The sensor may be configured for coupling to the subject. The respiratory waveform may include a plurality of respiratory cycles each corresponding to at least one of a breath and an attempted breath of the subject. The method may also include identifying a breathing pattern within the respiratory waveform over a period of time. The breathing pattern may include a repeating pattern of a plurality of respiratory cycles followed by at least one respiratory cycle corresponding to a disordered breathing event. The method may also include generating a series of stimulation pulses with an implantable nerve stimulator configured for coupling to a hypoglossal nerve of the subject. The series of stimulation pulses may be coordinated with the breathing pattern.

Abstract: Devices, systems and methods of neurostimulation for treating obstructive sleep apnea. The system is adapted to send an electrical signal from an implanted neurostimulator through a stimulation lead to a patient's nerve at an appropriate phase of the respiratory cycle based on input from a respiration sensing lead. External components are adapted for wireless communication with the neurostimulator. The neurostimulator is adapted to deliver therapeutic stimulation based on inputs.

Abstract: A stimulation system for delivery of a stimulation signal to a hypoglossal nerve of a patient to treat obstructive sleep apnea. The stimulation system includes an implantable receiver coil configured to be implanted under a mandible of the patient; a nerve electrode coupled to the implantable receiver coil, the nerve electrode configured to deliver the stimulation signal to the hypoglossal nerve of the patient; an external pulse generator configured to generate the stimulation signal; and an external transmitter coil configured to wirelessly transmit the stimulation signal from the external pulse generator to the implantable receiver coil, the external transmitter coil being carried by an adhesive patch configured to be placed on the skin adjacent the implantable receiver coil under the mandible of the patient.

Abstract: A method of treating a patient, comprising: sensing a biological parameter indicative of respiration; analyzing the biological parameter to identify a respiratory cycle; identifying an inspiratory phase of the respiratory cycle; and delivering stimulation to a hypoglossal nerve of the patient, wherein stimulation is delivered if a duration of the inspiratory phase of the respiratory cycle is greater than a predetermined portion of a duration of the entire respiratory cycle.

Abstract: Implantable medical leads and/or lead extensions include a band that encapsulates a portion of conductors of the lead and/or lead extension. The band may be reflowed in order to provide the encapsulation of the conductors. The band may further be used to create a seal together with the surrounding lead body and an additional object such as a stiffener rod, stylet tube, and/or molding stylet, to allow a proximal area of a lumen of the lead body to be injection molded while prevent the injection molding material from proceeding past the band. When a stiffener rod is present in a proximal area of the lead and/or lead extension, additional stiffness is provided to the lead body to resist buckling of the lead body during insertion of the proximal end. The band may be bonded to the stiffener rod to fix the position of the stiffener rod relative to the conductors.

Abstract: An implantable neurostimulation system comprises a stimulation delivery lead and a neurostimulator. The stimulation delivery lead is coupled to an electrode. The neurostimulator is adapted to deliver a neurostimulation signal to the subject and comprises a microprocessor. The microprocessor is programmed to identify a stimulation operating window for the therapy including a first threshold and a second threshold. The second threshold comprises an awake level and an asleep level. Identifying the stimulation operating window comprises titrating a stimulation setting of the neurostimulator while the subject is awake until the first threshold and the awake level of the second threshold are identified. Identifying the stimulation operating window further comprises subsequently repeating the step of titrating the stimulation setting of the neurostimulator while the subject is asleep until the asleep level of the second threshold is identified.

Abstract: A method of providing a sleep apnea nerve stimulation therapy to a subject may include detecting a respiratory waveform of the subject with a sensor. The sensor may be configured for coupling to the subject. The respiratory waveform may include a plurality of respiratory cycles each corresponding to at least one of a breath and an attempted breath of the subject. The method may also include identifying a breathing pattern within the respiratory waveform over a period of time. The breathing pattern may include a repeating pattern of a plurality of respiratory cycles followed by at least one respiratory cycle corresponding to a disordered breathing event. The method may also include generating a series of stimulation pulses with an implantable nerve stimulator configured for coupling to a hypoglossal nerve of the subject. The series of stimulation pulses may be coordinated with the breathing pattern.

Abstract: Implantable medical leads and/or lead extensions include a band that encapsulates a portion of conductors of the lead and/or lead extension. The band may be reflowed in order to provide the encapsulation of the conductors. The band may further be used to create a seal together with the surrounding lead body and an additional object such as a stiffener rod, stylet tube, and/or molding stylet, to allow a proximal area of a lumen of the lead body to be injection molded while prevent the injection molding material from proceeding past the band. When a stiffener rod is present in a proximal area of the lead and/or lead extension, additional stiffness is provided to the lead body to resist buckling of the lead body during insertion of the proximal end. The band may be bonded to the stiffener rod to fix the position of the stiffener rod relative to the conductors.

Abstract: A medical lead system includes a lead body, a plurality of electrical conductors, and a plurality of electrodes. The lead body may include a distal end and a proximal end defining a longitudinal axis of the lead body. The plurality of electrical conductors extending about the longitudinal axis of the lead body. The plurality of electrodes is positioned around an outer perimeter of the lead body. An inner surface of each of the plurality of electrodes defines an inner perimeter. Each respective electrode of the plurality of electrodes is electrically coupled to a respective electrical conductor of the plurality of electrical conductors. Each electrode of the plurality of electrodes includes at least one electrode locking feature extending into the lead body from the inner perimeter.

Abstract: A medical lead system includes a lead body, a plurality of electrical conductors, and a plurality of electrodes. The lead body may include a distal end and a proximal end defining a longitudinal axis of the lead body. The plurality of electrical conductors extending about the longitudinal axis of the lead body. The plurality of electrodes is positioned around an outer perimeter of the lead body. An inner surface of each of the plurality of electrodes defines an inner perimeter. Each respective electrode of the plurality of electrodes is electrically coupled to a respective electrical conductor of the plurality of electrical conductors. Each electrode of the plurality of electrodes includes at least one electrode locking feature extending into the lead body from the inner perimeter.

Abstract: Devices and methods for treating obstructive sleep apnea by first performing an assessment of the patient that involves observing the patient's upper airway during a tongue protrusion maneuver. The assessment may, for example, be done using endoscopy to observe the upper airway while the patient is awake in the supine position. An adequate response of the upper airway during the tongue protrusion maneuver is indicative of likely therapeutic success with hypoglossal nerve stimulation, and may be used for making clinical decisions. The principles of the present invention may be applied to other therapeutic interventions for OSA involving the upper airway.

Abstract: An assembly for forming a medical lead includes a lead body, a plurality of electrical conductors extending about a longitudinal axis of the lead body, and at least one segmented electrode preform that includes an electrically conductive ring and an insulator portion within the electrically conductive ring. The electrically conductive ring includes a plurality of electrode portions and a plurality of raised portions that alternate continuously around the ring. Each of the plurality of electrode portions is continuous at a radius from a center of the electrically conductive ring that corresponds to an outer perimeter of the medical lead. The insulator portion has a plurality of projections each extending into a respective raised portion of the ring beyond a radius that corresponds to the outer perimeter of the medical lead. Each respective electrode portion is electrically coupled to a respective electrical conductor of the plurality of electrical conductors.

Abstract: Implantable medical leads and/or lead extensions include a band that encapsulates a portion of conductors of the lead and/or lead extension. The band may be reflowed in order to provide the encapsulation of the conductors. The band may further be used to create a seal together with the surrounding lead body and an additional object such as a stiffener rod, stylet tube, and/or molding stylet, to allow a proximal area of a lumen of the lead body to be injection molded while prevent the injection molding material from proceeding past the band. When a stiffener rod is present in a proximal area of the lead and/or lead extension, additional stiffness is provided to the lead body to resist buckling of the lead body during insertion of the proximal end. The band may be bonded to the stiffener rod to fix the position of the stiffener rod relative to the conductors.

Abstract: A method including chronically implanting a nerve cuff electrode on a portion of a hypoglossal nerve, chronically implanting a respiration sensing lead subcutaneously in a thorax of a patient, the respiration sensing lead having a plurality of bio-impedance electrodes defining at least one bio-impedance vector. The method may also include sensing a bio-impedance signal corresponding to respiration via a bio-impedance vector on an anterior side of the thorax, analyzing the bio-impedance signal to identify onsets of expiration, predicting an onset of a future expiratory phase, and delivering a stimulus to the portion of the hypoglossal nerve via the nerve cuff electrode, wherein the stimulus is delivered as a function of the bio-impedance signal; wherein stimulus delivery is initiated before the onset of the future expiratory phase and continued during an entire inspiratory phase, and wherein the method is performed without identifying an onset of an inspiratory phase.

Abstract: An implantable neurostimulation system comprises a stimulation delivery lead and a neurostimulator. The stimulation delivery lead is coupled to an electrode. The neurostimulator is adapted to deliver a neurostimulation signal to the subject and comprises a microprocessor. The microprocessor is programmed to identify a stimulation operating window for the therapy including a first threshold and a second threshold. The second threshold comprises an awake level and an asleep level. Identifying the stimulation operating window comprises titrating a stimulation setting of the neurostimulator while the subject is awake until the first threshold and the awake level of the second threshold are identified. Identifying the stimulation operating window further comprises subsequently repeating the step of titrating the stimulation setting of the neurostimulator while the subject is asleep until the asleep level of the second threshold is identified.

Abstract: Devices, systems and methods of neurostimulation for treating obstructive sleep apnea.

Abstract: Devices, systems and methods for nerve stimulation for OSA therapy.

Abstract: In one embodiment, a method for maintaining patency of an upper airway of a patient to treat obstructive sleep apnea may include delivering an electrical stimulation to a portion of a superior laryngeal nerve via a nerve cuff when the nerve cuff is adjacent an external surface of the superior laryngeal nerve, the nerve cuff having a plurality of electrodes, wherein the nerve cuff is configured to be connected to an electrical stimulator via a stimulation lead.