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WO2024233013A1 - Thérapie d'apnée obstructive du sommeil basée sur le rythme respiratoire - Google Patents

Thérapie d'apnée obstructive du sommeil basée sur le rythme respiratoire Download PDF

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Publication number
WO2024233013A1
WO2024233013A1 PCT/US2024/022326 US2024022326W WO2024233013A1 WO 2024233013 A1 WO2024233013 A1 WO 2024233013A1 US 2024022326 W US2024022326 W US 2024022326W WO 2024233013 A1 WO2024233013 A1 WO 2024233013A1
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Prior art keywords
cycles
rate
cycle
respiration
therapy
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English (en)
Inventor
Erik J. Peterson
Thaddeus S. Brink
Kanthaiah KOKA
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Medtronic Inc
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Medtronic Inc
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Publication of WO2024233013A1 publication Critical patent/WO2024233013A1/fr
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3601—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation of respiratory organs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/08—Measuring devices for evaluating the respiratory organs
    • A61B5/0816—Measuring devices for examining respiratory frequency
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/08—Measuring devices for evaluating the respiratory organs
    • A61B5/0826—Detecting or evaluating apnoea events
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/103—Measuring devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
    • A61B5/11—Measuring movement of the entire body or parts thereof, e.g. head or hand tremor or mobility of a limb
    • A61B5/113—Measuring movement of the entire body or parts thereof, e.g. head or hand tremor or mobility of a limb occurring during breathing
    • A61B5/1135—Measuring movement of the entire body or parts thereof, e.g. head or hand tremor or mobility of a limb occurring during breathing by monitoring thoracic expansion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/48—Other medical applications
    • A61B5/4806—Sleep evaluation
    • A61B5/4818—Sleep apnoea
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/48—Other medical applications
    • A61B5/4836—Diagnosis combined with treatment in closed-loop systems or methods
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/686—Permanently implanted devices, e.g. pacemakers, other stimulators, biochips
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/3606—Implantable neurostimulators for stimulating central or peripheral nerve system adapted for a particular treatment
    • A61N1/3611—Respiration control
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/36128—Control systems
    • A61N1/36135—Control systems using physiological parameters

Definitions

  • This disclosure relates to medical systems and, more particularly, to medical systems for deliver ⁇ ' of electrical stimulation therapy.
  • Obstructive sleep apnea which encompasses apnea and hypopnea, is a disorder in which breathing may be irregularly and repeatedly stopped and started during sleep, resulting in disrupted sleep and reduced blood oxygen levels. Muscles in a patient’s throat intermittently relax thereby allowing soft tissues of the throat to obstruct the upper airway while sleeping and cause OSA. Airflow into the upper airway can be obstructed by the tongue or soft pallet moving to the back of the throat and covering the airway. Loss of air flow also causes unusual inter-thoracic pressure as a person tries to breathe with a blocked airway.
  • devices, systems, and techniques of this disclosure relate to delivery of medical therapy for obstructive sleep apnea (OSA) to a patient based on a respiration rate of the patient.
  • OSA obstructive sleep apnea
  • the devices, systems, and techniques of this disclosure can be extended to address other patient symptoms and disorders.
  • OSA obstructive sleep apnea
  • a patient’s tongue may relax during sleep and block the patient’s airway.
  • Some example techniques to address OSA include electrically stimulating one or both hypoglossal nerves and/or motor points in the tongue of the patient.
  • the hypoglossal nerve(s) causes protrusor muscles (e.g., genioglossus and geniohyoid muscles) to contract and move the tongue forward, thereby opening the airway.
  • protrusor muscles e.g., genioglossus and geniohyoid muscles
  • the protrusor muscles may contract to move the tongue forward, thereby opening the airway.
  • a medical device To stimulate the hypoglossal nerve(s) and/or motor points, a medical device outputs electrical stimulation therapy via one or more electrodes on one or more implanted leads to cause the tongue to move forward.
  • the electrical stimulation therapy may define one or more cycles of an electrical signal. Each cycle may include an on-cycle and an off- cycle immediately following the on-cycle.
  • Tire medical device may stimulate the hypoglossal nerve(s) anchor motor points during an inspiration phase of a respiratory cycle of tire patient, e.g., to prevent obstruction of the airway by the tongue during inhalation of the patient.
  • the medical device may determine when to output electrical signals of the electrical stimulation therapy during on-cycles of the cycles of the electrical signals and the duration of the on-cycles based on the respiration rate of the patient.
  • Parameters of the respiration by the patient may vary over time, e.g., due to a sleep state of the patient, the temperature, the humidity, any diseases afflicting the patient, the effects of any pharmaceutical substances on the patient, or the like.
  • the medical device delivers the stimulation therapy based on the timing of prior inspiration phases
  • the hypoglossal nerve(s) and/or motor points may not be stimulated during a sufficient portion of subsequent inspiration phases to deliver effective therapy to the patient, e.g., due to changes in the respiration rate and thereby the timing of subsequent inspiration phases.
  • timing and/or duration of respiratory’ phases may vary while the respiration rate of the patient remains constant.
  • using the timing of respiratory phases to determine the timing of the delivery of electrical signals of electrical stimulation therapy may cause the medical device to unnecessarily adjust stimulation parameters (e.g., electrical stimulation therapy frequency, therapy duration, pulse widths, duty cycles) in response to localized variations in the duration of the respiratory phase that are not indicative of larger trends in the respiration parameters.
  • stimulation parameters e.g., electrical stimulation therapy frequency, therapy duration, pulse widths, duty cycles
  • This disclosure describes devices, systems, and methods tor determining stimulation parameters of an electrical stimulation therapy based on the respiration rate of the patient.
  • the stimulation parameters may include, but are not limited to, a therapy cycling rate defining the timing of on-cycles and off-cycles of the cycles of the electrical stimulation therapy, duration of on-cycles and off-cycles within a single cycle of the electrical stimulation therapy, or a duty cycle of the cycles of the electrical stimulation therapy.
  • a medical device may output electrical signals during on-cycles of cycles of the electrical stimulation therapy to stimulate the hypoglossal nerve(s) and/or motor points and deliver efficacious therapy to the patient.
  • the medical device may not output electrical signals during off-cycles of the cycles of the electrical stimulation therapy to allow time for the tongue of the patient to recover, e.g., to prevent fatigue of the tongue.
  • the medical device may determine or receive an average respiration rate of the patient across a time period and determine stimulation parameters such that when the medical device delivers electrical signals during on-cycles of the electrical stimulation therapy in accordance with the stimulation parameters, the electrical signals may stimulate the hypoglossal nerve(s) and/or motor points during at least a threshold percentage of subsequent inspiration phases while the patient respirates at the average respiration rate. Based on the determined stimulation parameters, the medical device may then deliver the electrical stimulation therapy to the patient by outputing electrical signals to stimulate the hypoglossal nerve(s) and/or motor points in accordance with the stimulation parameters.
  • Delivering electrical stimulation therapy based on the respiration rate of the patient may provide several benefits over delivering electrical stimulation therapy based on the timing of respiratory phases of the patient.
  • a medical system may determine the respiration rate and changes in the respiration rate through a faster and simpler process than the determination of the duration of respiratory phases and changes in the respiratory phases. Therefore, a medical device delivering the electrical stimulation therapy based on the respiration rate may require lower computing capacity and may expend lower amounts of power to efficaciously deliver electrical stimulation therapy to the patient. Additionally, the medical system may utilize sensed data corresponding to a larger number of respiration cycles to determine the respiration rate compared to determining the timing of respiratory phases within individual respiration cycles.
  • the medical system may be more dynamic in response to larger-scale changes m the respiration of the patient and may be more resistant to make unnecessary changes to the stimulation parameters in response to localized changes in the respiration of the patient when delivering electrical stimulation therapy based on the respiration rate.
  • the use of the larger number of respiration cycles may allow for optimization of the electrical stimulation therapy, e.g., to reduce power consumption and increase operational lifespan of the medical system.
  • the devices, systems, and techniques described herein are primarily described with reference to treating obstructive sleep apnea (OSA), the devices, systems, and/or techniques described herein may be applied to deliver electrical stimulation signals to the body of the patient based on the respiration cycle of the patient to treat other diseases, symptoms, and/or conditions experienced by the patient such as, but is not limited to, chronic pain, epilepsy, movement disorders (e.g., Parkinson’s Disease, dystonia, or Essential Tremor), depression, stroke rehabilitation, tinnitus, migraines, autonomic dysreflexia or arthritis.
  • OSA obstructive sleep apnea
  • the devices, systems, and/or techniques described herein may be applied to deliver electrical stimulation signals to the body of the patient based on the respiration cycle of the patient to treat other diseases, symptoms, and/or conditions experienced by the patient such as, but is not limited to, chronic pain, epilepsy, movement disorders (e.g., Parkinson’s Disease, dystonia, or Essential Tre
  • the disclosure describes a system comprising: an implantable medical device (IMD) configured to deliver an electrical signal at or near a hypoglossal nerve of a patient to treat obstructive sleep apnea (OSA); one or more sensors; and processing circuitry in communication with the IMD and the one or more sensors, the processing circuitry being configured to: receive, via the one or more sensors, a data set corresponding to respiration of the patient during a time period; determine, based on the received data, a respiration rate of the patient over the time period; determine, based on the respiration rate, a therapy cycling rate of the electrical signal, wherein the therapy cycling rate defines a frequency for a plurality of on-cycles and a plurality of off-cycles of the electrical signal, wherein temporally adjacent on-cycles of the plurality of on-cycles are separated by an off-cycle of the plurality of off-cycles, and wherein the plurality of on- cycles overlaps a threshold percentage of subsequent inspiration phases
  • the disclosure describes a method for treating obstructive sleep apnea (OSA), the method comprising: sensing, via one or more sensors of a medical system, a data set corresponding to respiration of a patient during a time period; determining, by processing circuitry’ of the medical system and based on the data set, a respiration rate of the patient over the time period; determining, by the processing circuitry' and based on the respiration rate, a therapy cy cling rate of an electrical signal, wherein the therapy cycling rate defines a frequency of a plurality of on-cycles and a plurality' of off- cycles of the electrical signal, wherein temporally adjacent on-cycles are separated by an off-cycle, and wherein at the frequency, the plurality of on-cycles overlaps a threshold percentage of subsequent inspiration phases when the electrical signal is delivered at the therapy cycling rate; and causing, by the processing circuitry’, an IMD of the medical system to deliver the electrical signal at or near a hypo
  • the disclosure describes a computer-readable medium comprising instructions that, when executed, causes processing circuitry of a medical system to perform a method comprising: sensing, via one or more sensors of the medical system, a data set corresponding to respiration of a patient during a time period; determining, by the processing circuitry’ and based on the data set, a respiration rate of the patient over the time period; determining, by the processing circuitry' and based on the respiration rate, a therapy cycling rate of an electrical signal, wherein the therapy cycling rate defines a frequency of a plurality of on-cycles and a plurality' of off-cycles of the electrical signal, wherein temporally adjacent on-cycles are separated by an off-cycle, and wherein at the frequency, the plurality of on-cycles overlaps a threshold percentage of subsequent inspiration phases when the electrical signal is delivered at the therapy cycling rate; and causing, by the processing circuitry-’, an IMD of the medical system to deliver the electrical signal at or near a hypoglos
  • FIG. 1 is a conceptual diagram of an implantable medical device (IMD) system for delivering obstructive sleep apnea (OSA) therapy.
  • IMD implantable medical device
  • OSA obstructive sleep apnea
  • FIG. 2 is a block diagram illustrating example configurations of implantable medical devices (IMDs) which may be utilized in the system of FIG. 1.
  • IMDs implantable medical devices
  • FIG. 3 is a block diagram illustrating an example configuration of an external programmer.
  • FIG. 4 is a chart illustrating example respirator)? phases within respiration cycles of a patient.
  • FIG, 5A is a chart illustrating example timing diagrams of the delivery' of OSA therapy by the system of FIG. 1.
  • FIG. 5B is a chart illustrating example on-cycles and off-cycles of an example timing diagram of FIG. 5A.
  • FIG. 6 is a flow diagram illustrating an example process of delivering OSA therapy to the patient.
  • FIG. 7 is a flow diagram illustrating another example process of delivering OSA therapy to the patient.
  • FIG, 8 is a flow diagram illustrating another example process of delivering OSA therapy to the patient.
  • obstructive sleep apnea Medical devices, systems, and techniques for delivering electrical stimulation to the protrusor muscles of the tongue for the treatment of obstructive sleep apnea (OSA) are described in this disclosure. Electrical stimulation is delivered to cause the tongue of a patient to enter an advanced state, during sleep, to avoid or reduce upper airway obstruction.
  • advanced state with regard to the tongue refers to a position that is moved forward and/or downward compared to a non-stimulated position or a relaxed position of the tongue.
  • the advanced state is a state associated with contraction (e.g., via innervation from nerves in response to electrical stimulation) of protrusor muscles of the tongue (also sometimes referred to as “protruder” muscles of the tongue) including tire genioglossus and geniohyoid muscles.
  • An advanced state may be the opposite of a retracted and/or elevated position associated with the contraction of the retractor muscles (e.g., styloglossus and hyoglossus muscles) which retract and elevate the tongue.
  • Electrical stimulation is delivered to cause the tongue to move (e.g., by depolarizing the nerve(s) that innervate the genioglossus and/or geniohyoid muscles) and maintain an advanced state.
  • the advanced state may prevent collapse or blockage of, open, or widen the upper airway of a patient to at least partially maintain or increase airflow (e.g., promote unrestricted airflow or at least reduced restriction of airflow during breathing).
  • a surgeon implants one or more leads that each include one or more electrodes into the tongue or proximal anatomy such that the electrodes are proximate to a hypoglossal nerve and/or motor points (e.g., one or more locations where axons of the hypoglossal nerve terminate at respective muscle fibers of the protrusor muscles).
  • a hypoglossal nerve and/or motor points e.g., one or more locations where axons of the hypoglossal nerve terminate at respective muscle fibers of the protrusor muscles.
  • one lead may be used to stimulate (e.g., by delivering electrical stimulation through one or more electrodes of the lead) one of the two hypoglossal nerves, one lead may be used to stimulate both hypoglossal nerves, or two leads may be used, where each lead stimulates a respective one of the hypoglossal nerves. Stimulation of either or both hypoglossal nerves of the tongue can cause contraction of the protrusor muscles to reduce the effect of or prevent OSA.
  • Each motor point may innervate one or more muscle fibers of the protrusor muscle.
  • one lead may be used to stimulate motor points, including hypoglossal nerve, for the protrusor muscles on one side of the tongue, one lead may be used to stimulate motor points, including hypoglossal nerve, for protrusor muscles on both sides of the tongue, or two leads may be used, where each lead stimulates a respective set of motor points for the protrusor muscles on each side. Stimulation of either or both sets of motor points of the tongue can cause con traction of the protrusor muscles to reduce the effect of, or prevent, OSA.
  • Tlie medical system may determine, based on sensor data, a respiration rate of the patient (e.g., an average respiration rate over a time period).
  • the medical system may determine stimulation parameters (e.g., a therapy cycling rate, a duty' cycle) based on the respiration rate and deliver electrical signal at or near hypoglossal nerve(s) and/or motor points of the patient m accordance with the stimulation parameters.
  • stimulation parameters e.g., a therapy cycling rate, a duty' cycle
  • the therapy cycling rate may correspond to a frequency of cycles of the electrical signal of the electrical stimulation therapy.
  • Each cycle may include an on-cycle and an off-cycle temporally adjacent to the on-cycle. Temporally adjacent on-cycles may be separated by an off-cycle.
  • the medical system may be configured to deliver electrical signals during on-cycles and not to deliver electrical signals during off-cycles, e.g., to allow the tongue of the patient to recover between on-cycles.
  • Therapy cycling rate may define a duration of each cycle of the electrical signal.
  • a duty cycle of a cycle of the electrical signal may define a ratio between a duration of an on-cycle of the cycle to the total duration of the cycle.
  • a duty cycle of 70% may correspond to a cycle with an on-cycle encompassing 70% of the duration of the cycle and an off-cycle encompassing 30% of the duration of the cycle.
  • the timing e.g., the start times, the end times
  • the on-cycles and of the off-cycles may be defined by the therapy cycling rate and the duty cycle.
  • the medical system may deliver electrical signal(s) during each on-cycle of the cycles of the electrical signal.
  • the medical system may deliver electrical signal(s) in the form of a plurality of electrical pulses defining a pulse train or of a constant electrical signal.
  • the frequency of the plurality of electrical pulses may be defined by a stimulation rate.
  • the stimulation rate may be independent of the therapy cycling rate.
  • the medical system adjusts the timing and duration of on-cycles by adjusting the therapy cycling rate and/or the duty cycle.
  • adjustments to the therapy cycling rate and/or the duty cycle would not affect the stimulation rate and the medical system may deliver electrical pulses during on-cycles with different start times, end times, and cycle durations, wherein the electrical pulses are delivered to the patient at a same stimulation rate.
  • changes to the start times, ends times, and cycling durations may alter the number of electrical pulses delivered within each on-cycle without altering the duration of each electrical pulse and the recovery period between two temporally adjacent electrical pulses.
  • the medical system may determine the therapy cycling rate such that when the medical system delivers electrical signals to the patient during on-cycles defined in accordance with the frequency of the therapy cycling rate, the electrical signals may stimulate the hypoglossal nerve(s) and/or motor points during a threshold percentage of subsequent inspiration phases of the respiration of the patient.
  • Each subsequent inspiration phase may correspond to a period of inhalation by the patient during each subsequent respiration cycle.
  • Stimulation of the hypoglossal nerve(s) and/or motor points during the subsequent inspiration phases may cause the protrusor muscles to contract and move the tongue to the advanced state, e.g., to prevent blockage of the airway during inhalation by the patient.
  • the on-cycle may temporally overlap with the inspiration phase for at least a threshold amount of the inspiration phase (e.g., for at least 50% of the inspiration phase).
  • Temporally adjacent on-cycles of the electrical signal may be separated by an off-cycle during which the medical system does not deliver electrical signals to the tissue of the patient.
  • the duration of each pair of an on-cycle and an off-cycle may correspond to a duty cycle of a corresponding cycle of the electrical signal encompassing the on-cycle and the off-cycle.
  • the duty- cycle may be based on a cycle width of the on-cycle and on the therapy cycling rate.
  • the therapy cycling rate may define cycling times (e.g., start and end times) of the on-cycles and the off-cycles of the cycles of the electrical signal.
  • the cycling times of an on-cycle may correspond to a first time at which the medical system begins delivering the electrical signal and a second time at which the medical system terminates delivery of the electrical signal,
  • the cycling times of the plurality of cycles of the electrical signal may be independent of the timing and/or duration of individual inspiration phases of respiration cycles of the patient.
  • the medical system may determine, based on the respiration rate and a pre -determined ratio of the duration of inspiration phases to the duration of respiration cycles, the timing and duration of the inspiration phases relative to the respiration of the patient, e.g., independent of the actual timing and duration of the inspiration phases.
  • the medical sy stem may then determine the cycling times for the cy cles of the electrical signal (e.g., by determining the therapy cycling rate and/or the duty cycle of the cycles) such that the on-cycles of the electrical signal temporally overlap with the subsequent inspiration phases at a threshold percentage.
  • the respiration rate of the patient changes over time, e.g., due to changes in the sleep state of the patient, changes in the temperature and/or humidity of an environment surrounding the patient, changes in disease states, onset, cessation, or changes in the effects of any pharmaceutical substances on the patient, or the like.
  • the medical system may adjust, based on changes in the respiration rate, the stimulation parameters of the electrical signal. For example, the medical system may adjust the therapy cycling rate or the duty cycles of the cycles of the electrical signal based on the change in the respiration rate.
  • the medical system may deliver electrical signals (e.g., within on-cycles of the electrical signal) in accordance with the adjusted stimulation parameters such that the medical system stimulated the hypoglossal nerve(s) and/or motor points of the patient for at least the threshold percentage of inspiration phases while the patient is respiring at the new respiration rate.
  • electrical signals e.g., within on-cycles of the electrical signal
  • the medical system may determine, based on prior respiration rates, a trend in the change of the respiration rate of the patient overtime. Accordingly, the medical system may predict a future respiration rate based on the trend in the prior respiration rates.
  • the medical system may determine stimulation parameters (e.g., the therapy cycling rate, the duty cycle) for the future respiration rate and may deliver the electrical signals to the patient in accordance with the determined stimulation parameters.
  • Determining the stimulation parameters e.g., therapy cycling rate, the duty' cycle, the cycling times of cycles of the electrical signal
  • the medical system may avoid sensing data corresponding to the respiratory phases and determining the timing and duration of the respiratory phases as a part of the determining of the stimulation parameters, which may reduce the computing capability and power required for the medical system (e.g,, for an implantable device of the medical system) to determine the stimulation parameters.
  • Tire medical system may also determine the stimulation parameters at a faster rate, e.g., due to the reduction in the number of calculations required to determine stimulation parameters, thereby allowing the medical system to be more dynamic and responsive to changes in the respiration of the patient. [0037 ] Additionally, by determining the stimulation parameters based on the respiration rate over a period of time as opposed to the timing and duration of individual respiratory phases of individual respiration cycles, the medical system may be more responsive to relatively larger-scale changes in the respiration of the patient (e.g., across a number of respiration cycles) and less responsive to localized changes in individual respirati on cycles that do not affect the respiration rate of the patient across multiple respiration cycles.
  • the medical system may more quickly adjust the stimulation parameters in response to changes in the respiration rate and more resistant to unnecessary changes to the stimulation parameters over localized variations in individual respiration cycles, thereby increasing efficacy of the OSA therapy delivered by the medical system.
  • the medical system may also be able to better satisfy additional objectives over time by determining the stimulation parameters based on the respiration rate instead of the individual respiration phases. For example, by adjusting stimulation parameters based on the respiration rate, the medical system may be able to better optimize therapy delivery and power consumption over time by adjusting stimulation parameters in response to a larger number of respiration cycles.
  • FIG, 1 is a conceptual diagram of a medical system for delivering OSA therapy.
  • implantable medical device (IMD) 104 and lead 106 are implanted in patient 102.
  • IMD 104 includes housing 108 enclosing circuitry of IMD 104.
  • IMD 104 includes connector assembly 1 10, which is hermetically sealed to housing 108 and includes one or more connector bores for receiving a proximal end of at least one medical electrical lead 106 (also referred to as “implantable medical lead 106”, “lead 106”) used for delivering OSA therapy.
  • one lead 106 is illustrated in FIG. 1, there may be one or more leads 106 to which IMD 104 is coupled.
  • Lead 106 may include a flexible, elongated lead body 112 (also referred to as “elongated member 112”) extending from lead proximal end 114 to lead distal end 115. As illustrated in FIG. 1, lead 106 includes one or more electrodes 1 17 that are carried along a lead distal portion adjacent lead distal end 116 and are configured for insertion within the protrusor muscles 120A, 120B, and 122 of tongue 118. As one example, the genioglossus muscle includes oblique compartment 120A and horizontal compartment 120B. In this disclosure, the genioglossus muscle is referred to as protrusor muscle 120. Protrusor muscle 122 is an example of the geniohyoid muscle.
  • Lead body 112 includes one or more electrodes 117 and one or more fixation elements.
  • protrusions, tines indentations, creases, or other texturing may be disposed on the outer surface of lead body 112 and/or between electrodes 117. The texturing may increase friction between the tissue of patient 102 and lead body 112 and may prevent dislodgement of lead 106 within the tissue.
  • Proximal end 114 of lead 106 includes one or more electrical contacts to connect to connector assembly 110.
  • Lead 106 also includes conductors such as coils or wires that connect respective electrodes 117 to respective electrical contacts at proximal end 1 14 of lead 106.
  • the clinician may secure lead 106 within protrusor muscles 120 and/or 12.2 via fixation elements.
  • the fixation elements may be in an undeployed state, due a sheath covering the fixation elements, while the clinician positions lead 106. The clinician may then remove the sheath to deploy the fixation elements.
  • Tongue 118 includes a distal end (e.g., tip of tongue 118), and electrodes 117 may be implanted proximate to a root of tongue 118. Ihe surgeon may implant one or more leads 106 such that one or more electrodes 117 and/or distal electrode 119 are implan ted proximate to the root of tongue 118, as illustrated in FIG. 1.
  • the location for stimulation for tlie genioglossus muscle 120 may be approximately 30 mm (e.g., 25 mm to 35 mm) from the symphysis of the jaw (e.g., where the genioglossus and hypoglossal muscles insert).
  • the location for stimulation for the geniohyoid muscle 122 may be approximately 40 mm (e.g., 35 mm to 45 mm) from the symphysis.
  • tire location for stimulation may be approximately 11 mm (e.g., 7 mm to 15 mm) lateral to the midline on both the right and left sides of tongue 118 for stimulating respective hypoglossal nerves.
  • the examples described in this disclosure may be configured for stimulating the motor points.
  • Stimulating the motor points may result in indirect activation of the hypoglossal nerve but may generally be stimulating at a different location than direct stimulation to the hypoglossal nerve.
  • simulation of one or more motor points may result in more precise activation of muscle fibers than may be possible with stimulation of the hypoglossal nerve itself.
  • One or more electrodes 1 17 of lead 106 may be ring electrodes, segmented electrodes, partial ring electrodes, or any suitable electrode configuration. Ring electrodes extend 360 degrees around the circumference of lead body 112 of lead 106. Segmented and partial ring electrodes each extend along an arc less than 360 degrees (e.g., 90-120 degrees) around the outer circumference of lead body 1 12 of lead 106. In this manner, multiple segmented electrodes may be disposed around the perimeter of lead 106 at the same axial position of the lead.
  • segmented electrodes may be usefill for targeting different fibers of the same or different nerves at respective circumferential positions with respect to the lead to generate different physiological effects (e.g., therapeutic effects), permiting stimulation to be oriented directionally.
  • lead 106 may be, at least in part, paddle-shaped (e.g., a "‘paddle” lead), and may include an array of electrodes arranged as contacts or pads on a common surface, which may or may not be substantially flat and planar.
  • electrodes 117 and/or distal electrode 119 of lead 106 are disposed within the musculature of tongue 118. Accordingly, one or more electrodes 1 17 and/or distal electrode 119 of lead 106 may be “intramuscular electrodes.” Intramuscular electrodes may be different than other electrodes that are placed on or along a nerve trunk or branch, such as a cuff electrode, used to directly stimulate the nerve trank or branch. The example techniques described in this disclosure are not limited to intramuscular electrodes and may be extendable to electrodes placed closer to a nerve trunk or branch of the hypoglossal nerve(s). Also, in some examples, one or more electrodes 1 17 of lead 106 may be implanted in connective tissue or other soft tissue proximate to the hypoglossal nerve.
  • Electrical stimulation therapy generated by IMD 104 and delivered via one or more electrodes 117 and/or the distal electrode 119 may activate protrusor muscles 120 and 122 to move tongue 118 forward, for instance, to promote a reduction in obstruction or narrowing of the upper airway 124 during sleep.
  • the term “activated” with regard to the electrical stimulation of protrusor muscles 120 and 122 may activate protrusor muscles 120 and 122 to move tongue 118 forward, for instance, to promote a reduction in obstruction or narrowing of the upper airway 124 during sleep.
  • protrusor muscles 120 and 122 refers to electrical stimulation that causes depolarization or an action potential of the cells of the nerve (e.g., hypoglossal nerve(s)) or stimulation at the neuro-muscular junction between the nerve and the protrusor muscles (e.g., at the motor points) innervating promisor muscles 120 and 122 and motor points and subsequent depolarization and mechanical contraction of the protrusor muscle cells of protrusor muscles 120 and 122.
  • protrusor muscles 120 and 122 may be activated directly by the electrical stimulation therapy.
  • Protrusor muscles 12.0 and/or 122, on a first side of tongue 118 may be activated by a medial branch or more distal end of a first hypoglossal nerve
  • the protrusor muscles, on a second side of tongue 118 may be activated by a medial branch or more distal end of a second hypoglossal nerve.
  • Tire medial branch of a hypoglossal nerve may also be referred to as the Xllth cranial nerve.
  • the hyoglossus and styloglossus muscles (not shown in FIG. 1), which cause retraction and elevation of tongue 118, are activated by a lateral branch of the hypoglossal nerve.
  • One or more electrodes 117 and/or distal electrode 1 19 may be used to deliver bilateral or unilateral stimulation to protrusor muscles 120 and 122 via the medial branch of the hypoglossal nerve or branches of the hypoglossal nerve (e.g., such as at the motor point where a terminal branch of the hypoglossal nerve interfaces with respective muscle fibers of protrusor muscles 120 and/or 122).
  • Hie examples of the location of delivery' of stimulation is provided as examples, and should not be considered limiting.
  • one or more electrodes 1 17 and/or distal electrode 1 19 may be coupled to output circuitry? of IMD 104 to enable delivery' of electrical stimulation pulses in a manner that selectively activates the right and left protrusor muscles (e.g., in a periodic, cyclical, or alternating pattern) to avoid muscle fatigue while maintaining upper airway patency.
  • IMD 104 may deliver electrical stimulation to selectively activate protrusor muscles 120 and/or 122 or portions of protrusor muscles 120 and/or 122 during unilateral stimulation of the left or right protrusor muscles.
  • one lead 106 may be implanted such that one or more of electrodes 117 and/or distal electrode 1 19 may deliver electrical stimulation to stimulate the left hypoglossal nerve or motor points of protrusor muscles on the left side of tongue, and therefore cause tire left protrusor muscles to activate.
  • the electrical stimulation from one or more electrodes 117 and/or distal electrode 1 19 may not be of sufficient amplitude to stimulate the right hypoglossal nerve or motor points of protrusor muscles on the right side of tongue and cause the right protnisor muscles to activate.
  • one lead 106 may be implanted such that one or more of electrodes 1 17 and/or distal electrode 119 delivers electrical stimulation to stimulate the right hypoglossal nerve or motor points of protrusor muscles on the right side of tongue, and therefore cause the right protrusor muscles to activate.
  • the electrical stimulation from one or more electrodes 117 and/or distal electrode 1 19 may not be of sufficient amplitude to stimulate the left hypoglossal nerve or motor points of protnisor muscles on the left side of tongue and cause the left protrusor muscles to activate.
  • two leads like lead 106 may be implanted to stimulate each of the left and right hypoglossal nerves and/or motor points of respective protnisor muscles on the left and right side of tongue 118.
  • one lead 106 may be implanted substantially in the middle (e.g., center) of tongue 118.
  • one or more electrodes 1 17 and/or distal electrode 119 may deliver electrical stimulation to both hypoglossal nerves or motor points of both muscles on both sides of tongue 118, causing both hypoglossal nerves or motor points to activate respective left and right protrusor muscles.
  • one or more electrodes 117 and/or distal electrode 119 deliver first electrical stimulation that stimulates the left hypoglossal nerve or motor points of protrusor muscles on the left side of tongue 118 with little to no stimulation of the right hypoglossal ncn e or motor points of protrusor muscles on the right side of tongue 118, and then one or more electrodes 117 and/or distal electrode 119 deliver second electrical stimulation that stimulates the right hypoglossal nerve or motor points of protrusor muscles on the right side of tongue w ith little to no stimulation of the left hypoglossal nerve or motor points of protrusor muscles on the left side of tongue.
  • each lead mayalternate delivery of stimulation to respective hypoglossal nerves or motor points.
  • IMD 104 may stimulate one hypoglossal nerve or one set of motor points and then the other hypoglossal nerve or another set of motor points, which can reduce muscle fatigue.
  • continuous stimulation may cause protnisor muscles to be continuously in an advanced state.
  • This continuous contraction may cause protnisor muscles 120 and/or 122 to fatigue.
  • the stimulation may not cause protrusor muscles 120 and/or 122 to maintain an advanced state (or higher intensity of the electrical stimulation may be needed to cause protrusor muscles 120 and/or 122 to remain in the advanced state).
  • a second set e.g., other of left or right of protrusor muscles can be at rest.
  • Stimulation may then alternate to stimulate the protrusor muscles that were at rest and thereby maintain protrusion of tongue 1 18 while permitting the protrusor muscles 120 and/or 122 that were previously activated to rest.
  • tongue 118 can remain in the advanced state, while one of the fi rst or second set of protrusor muscles is at rest. Cycling between left and right protrusors can be independent of respiratory rate and individual respiratory phases.
  • one lead 106 may be implanted laterally or diagonally across tongue 118 such that some of electrodes 117 and/or distal electrode 1 19 on lead 106 can be used to stimulate the left hypoglossal nerve and/or motor points of the protrusor muscles on the left side of tongue 118 and some of electrodes 117 and/or distal electrode 119 on the same lead 106 can be used to stimulate the right hypoglossal nerve and/or motor points of the protrusor muscles on the right side of tongue 118.
  • IMD 104 may selectively deliver electrical stimulation to a first hypoglossal nerve and/or first motor points of the protrusor muscles on a first side of tong ue 118 via a first set of one or more electrodes 117 and/or distal electrode 119, and then deliver electrical stimulation to a second hypoglossal nerve and/or second set of motor points of the protrusor muscles on a second side of tongue 118 via a second set of one or more electrodes 117 and/or distal electrode 119.
  • Tongue 118 may transition between the advanced state (e.g., in response to the electrical stimulation by IMD 104) and an un-advanced (e.g., relaxed) state.
  • Lead proximal end 114 includes a connector (not shown in FIG. 1) that may be coupled to connector assembly 1 10 of IMD 104 to provide electrical connection between circuitry' enclosed by the housing 108 of IMD 104.
  • Lead body 1 12 encloses electrical conductors extending from each of one or more electrodes 117 and/or distal electrode 1 19 to the proximal connector at proximal end 114 to provide electrical connection between output circuitry of IMD 104 and the electrodes 117.
  • lead 106 is implanted in patient 102. A clinician may insert the needle through the lower part of the jaw and in tongue 1 18 starting from the back of tongue 1 18.
  • the clinician may insert the needle until a distal tip of the needle reaches a point at or adjacent to the root of tongue 118, angling the needle to extend proximate to the hypoglossal nerve (e.g., left or right hypoglossal nerve).
  • the needle may include one or more electrically conductive areas (e.g., one or more electrodes) at the distal end, and the clinician may cause the one or more electrically conductive areas of the needle to output electrical stimulation (e.g., in the form of controlled current pulses or controlled voltage pulses), which in turn causes a physiological response such as activation of protrusor muscles 120 and/or 122 and advancement of tongue 118.
  • the one or more electrodes may be disposed on an outer surface of the needle. The clinician may adjust the location of the needle based on the physiological response to determine a location in tongue 118 that provides effective treatment.
  • the clinician may retract needle from within tongue 118, advance an introducer into tongue 118 via a path formed by the needle, and advance lead 106 through the introducer lumen of the introducer.
  • Tire clinician may determine lead 106 is at a desired position within tongue 118, secure lead 106 within tongue 118 via fixation elements, and retract the introducer from within tongue 118 once lead 106 is secured within tongue 118.
  • the clinician may advance an introducer and a dilator into tongue 1 18 and determine the desired position within tongue 118 by delivering and sensing electrical signals via one or more electrodes disposed on tire introducer.
  • the surgeon may implant one lead 106.
  • the surgeon may perform steps similar to those described above.
  • IMD 104 may output stimulation signals through electrodes 117 to stimulate the hypoglossal nen e and/or one or more motor points of the protrusor muscle within tongue 118. If further refinement is needed to determine the lead placement for lead 106, the chmcian may adjust the location of needle and/or lead 106 within patient 102 in response to one or more electrical signals detected by electrodes 117 and/or electrodes on the needle.
  • IMD 104 may not yet be implanted within body of patient 102.
  • the clinician may implant IMD 104 within patient 102 (e.g., in the neck of patient 102, in the torso of patient 102, or the like) to complete the implantation of system 100.
  • lead 106 may be connected to another computing device and/or system (e.g., an external programming device) and the other computing device and/or system mayoutput the stimulation signals for purposes of delivering the lead placement for lead 106.
  • FIG. 1 illustrates the location of IMD 104 as being within or proximate to the neck of patient 102.
  • IMD 104 may be implanted in various other locations.
  • the surgeon may implant IMD 104 in the left or right pectoral region.
  • the surgeon may plan on implanting IMD 104 in the left pectoral region unless another medical device is already implanted m the left pectoral region. If another medical device is already implanted in the left pectoral region, the surgeon may then implant IMD 104 in the right pectoral region.
  • the example techniques are not limited to any particular implant location of IMD 104.
  • system 100 is an implant sy stem for utilizing lead 106 in tongue 118 for treatment of OSA.
  • system 100 may- be configured such that substantial dissection is not required to expose one or more hypoglossal nerves and/or one or more motor points of the protrusor muscle within tongue 118 for placement of the lead.
  • system 100 may be configured such that a surgeon may- implant the needle and lead 106 within patient 102 using a. relatively smaller number of devices (e.g., without the use of an introducer sheath, guide members (e.g., a guidewire), a dilator, and the like).
  • IMD 104 may output stimulation signals (e.g., the electrical signal) through electrodes 1 17 to tissue at or near the hypoglossal nerve(s) and/or motor potions within tongue 118 at a determined therapy cycling rate.
  • the therapy cycling rate may correspond to a frequency of the plurality of cycles of the electrical signal. Each cycle may include an on-cycle and an off-cycle.
  • IMD 104 may output an electrical signal during each on-cycle of the cycles of the electrical signal .
  • IMD 104 may output the electrical signal in the form of a plurality of electrical pulses defining a pulse train or a constant electrical signal, bubble pulse train may be delivered at a corresponding stimulation rate, e.g., to elicit a sustained muscle contraction within tongue 118 during the pulse of the electrical signal.
  • the stimulation rate may be about 30 Hertz (Hz) to about 40 Hz.
  • Tire stimulation rate for the pulse train may be independent of the therapy cycling rate for the pulses of the electrical signal.
  • System 100 may determine stimulation parameters of the electrical signal (e.g., the therapy cycling rate, the duty cycle of the cycle, the cycling times of the cycles of electrical signals) based on a respiration rate of patient 102.
  • IMD 104 may deliver a first plurality of electrical pulses during on-cycles with a first duration and may deliver a second plurality of electrical pulses during on-cycles with a second duration.
  • the duration of on-cycles may affect a number of electrical pulses delivered by IMD 104 but may not affect the duration of each electrical pulse or the duration of recovery periods between adjacent electrical pulses.
  • the respi ration rate of patient 102 may correspond to a number of respiration cycles within a time period.
  • Each respiration cycle may include two respiratory phases (i.e., an inspiration phase and an expiration phase).
  • patient 102 inhales during the inspiration phase, e.g., through airway 124 of patient 102, and exhales during the expiration phase, e.g., through airway 124. That is, the inspiration phase is the amount of time during which patient 102 is inhaling in a respiration cycle, and the expiration phase is the amount of time during which patient 102 is exhaling in the respiration cycle.
  • System 100 may stimulate tongue 118 to extend tongue in the advanced state during inspiration phases, e.g., to prevent blocking of airway 124 by tongue 1 18. Tongue 118 may return to the rest position during expiration phases, e.g., to allow protrusor muscles in tongue 1 18 to rest and recover between inspiration phases. However, it may not be necessary for tongue 1 18 to rest and recover between inspiration phases, and stimulation may be delivered during the expiration phase, or at least partially overlapping with the expiration phase.
  • System 100 may sense or receive sensor data corresponding to a number of respiration cycles experienced by patient 102 within a set time period. System 100 may then determine, based on the sensor data, a respiration rate of patient 102. System 100, may determine, based on the respiration rate, an inspiration rate and/or timing of inspiration phases during respiration by patient 102 at the respiration rate. Tire inspiration rate may be indicative of the number of inspiration phases over a period of time, and may be different than the respiration rate, which is a measure of a number of the entire respiration cycle over a period of time. System 100 may retrieve a predetermined ratio or percentage value indicating a percentage of each respiration cycle that corresponds to the inspiration phase.
  • Tlie predetermined percentage value may be based on data corresponding to prior respiration cycles by patient 102 and/or by one or more other patients.
  • system 100 determines the inspiration rate and/or the timing of the inspiration phases based on the respiration rate and the predetermined percentage, e.g., without sensing or retrieving sensor data corresponding to the actual timing of inspiration phase of one or more respiration cycles of patient 102.
  • system 100 may simplify process of determining stimulation parameters for the electrical stimulation therapy, e.g., by avoiding a need to determine the actual timing and durations of inspiration phases of respiration cy cles.
  • System 100 may determine, based on the respiration rate, one or more stimulation parameters for electrical signals of the electrical stimulation therapy.
  • the stimulation parameters may include, but are not limited to, the therapy cycling rate, dutycycle, cycling times for the cycles of the electrical signal, the cycle widths of cycles of the electrical signal, stimulation amplitude of the electrical signal, and stimulation rate of pulse trains within an on-cycle of the electrical signal.
  • the therapy cycling rate may include a frequency of a plurality of cycles of the electrical signal overtime.
  • System 100 may deliver electrical signals at the therapy cycling rate by delivering electrical signals during on-cycles of cycles of the electrical signal defined by the therapy cycling rate.
  • system 100 may deliver a constant electrical signal or a plurality of electrical pulses at or near the hypoglossal nerve(s) and/or motor points of patient 102.
  • the therapy cycling rate may be constant over time or may vary- based on changes in the respiration rate of patient 102. .
  • the cycling timing of the on-cycles and of the off-cycles of the cy cles of the electrical signal may correspond to two or more different therapy cycling rates at different times.
  • IMD 104 of system 100 may deliver electrical signals during on-cycles of a first number of cycles of the electrical signal at a first therapy cycling rate during a first time period and during on-cycles of a second number of cycles of the electrical signal at a second therapy cycling rate during a second time period.
  • the cycle width may be defined by the duty cycle for the cycle.
  • IMD 104 may deliver, during each on-cycle, a single constant electrical signal or plurality of electrical pulses at a stimulation rate to stimulate the tissue of patient 102.
  • the duty cycle may correspond to a ratio of the cycle width of the on-cycle of the cycle to the total cycle width of the cycle.
  • IMD 104 may deliver electrical signals during on-cycles and may not deliver electrical signals during off-cycles.
  • the duty cycle of each cycle may be defined by or may define the cycle widths and therapy cycling rates of the cycles of the elec trical signal.
  • the duty cycle and the therapy cycling rate may define the cycling times of the on- cycles and tire off-cycles of the electrical signal
  • the duty cycle may be constant across all cycles of a plurality’ of cycles of the electrical signal or may vary in response to changes in the respiration rate of patient 102.
  • the plurality of cycle of the electrical signal define two or more different duty cycles at different times.
  • the cycle widths and duty cycles of the cycles may remain constant regardless of the respiration rate of patient 102 and system 100 may control the timing of the on-cycles of the electrical signal by changing the therapy cycling rate.
  • Tire cycles of the electrical signal may define one or more types of waveforms including, but are not limited to, a square waveform, a sinusoidal waveform, or the like.
  • System 100 may determine stimulation parameters for the electrical signals such that when system 100 stimulates tongue 118 (e.g., via a plurality of pulses of the electrical signal) m accordance with the stimulation parameters, the electrical stimulation therapy satisfies a threshold condition.
  • the threshold condition may include stimulation at or near hypoglossal nerve(s) of patient 102 for at least a threshold percentage of subsequent inspiration phases.
  • the threshold percentage may be predetermined and may correspond to a level of desired efficacy of the OSA therapy. A higher threshold percentage may correspond to a higher level of efficacy.
  • the threshold condition may classify a successful stimulation of tongue 118 during an inspiration phase as a temporal overlap, by delivered electrical signals, of at least a threshold portion (e.g., 50%) of the inspiration phase.
  • Causing the delivered electrical signal to temporally overlap with at least the threshold portion of the inspiration phase may cause tongue 118 to remain in the advanced state for at least the threshold portion of the inspiration phase.
  • the stimulation parameters (e.g., of the therapy cycling rate, of the duty cycles of the cycles of the electrical signal) may be based on the determined respiration rate of patient 102 and maybe independent of the actual timing and duration of the inspiration phases of the respiration cycles used to determine the respiration rate.
  • system 100 may determine stimulation parameters by determining the respiration rate of patient 102 and without determining the actual timing and duration of the inspiration phases of the respiration cycles, e.g., based on sensed data.
  • the determination of the stimulation parameters may be based on the respiration rate and/or inspiration rate. However, determining the timing of cycles of the electrical signal may not require a determination of when tire inspiration phase will start. Rather, the simulation parameters may be such that whenever the electrical stimulation is delivered, there is a very high likelihood that the electrical stimulation will be delivered at or near the hypoglossal nerve for a threshold percentage of the inspiration phase.
  • system 100 may select values for the stimulation parameters (e.g., for duty r cycles, for therapy- cycling rates) for cycles of the electrical signal such that each on-cycle of a plurality of cycles defines a sufficiently cycle width to temporally overlap with an inspiration phase by at least the threshold portion of the duration of the inspiration phase regardless of the actual timing of the inspiration phase.
  • the start time and end time for each inspiration phase and the each respective on-cycle may be synchronized or desynchronized.
  • IMD 104 delivers the electrical signal at or near the hypoglossal nerve(s) and/or motor points of patient 102. during on-cycles, the electrical signal is started to be delivered at the start of an inspiration phase, during the inspiration phase, or before the start of the inspiration phase.
  • the therapy cycling rate and duty cycles for the cycles electrical signal may be such that for the threshold percentage of inspiration phases, the electrical signals delivered during on-cycles temporally overlap with at least the threshold portion of the inspiration phase.
  • System 100 may continue to monitor the respiration rate of patient 102 during delivery of the electrical stimulation therapy to patient 102 and may detect changes in the respiration rate of patient 102 over time. Based on the detected changes in the respiration rate, system 100 may adjust one or more stimulation parameters (e.g., the therapy cycling rate or the duty cycle) to maintain efficacy of the electrical stimulation therapy. For example, system 100 may alter the therapy cycling rate, cycling timing, and/or the dutycycle cycles pulses of the electrical signal of the electrical stimulation therapy based on a determined change in the respiration rate.
  • stimulation parameters e.g., the therapy cycling rate or the duty cycle
  • system 100 While system 100 is primarily described herein as being configured to treat OSA, portions of system 100 (e.g., IMD 104) may be implanted in other regions within the body of patient 102 and may deliver electrical stimulation therapy to the other regions, e.g., to treat one or more other diseases and/or conditions experienced by patient 102. A side from treatment of OSA, system 100 may improve the effi cacy of the electrical stimulation therapy for other medical conditions by delivering the therapy to patient 102 while patient 102 is asleep.
  • IMD 104 portions of system 100 (e.g., IMD 104) may be implanted in other regions within the body of patient 102 and may deliver electrical stimulation therapy to the other regions, e.g., to treat one or more other diseases and/or conditions experienced by patient 102.
  • system 100 may improve the effi cacy of the electrical stimulation therapy for other medical conditions by delivering the therapy to patient 102 while patient 102 is asleep.
  • the reduction of body movement while patient 102 is asleep may increase the fidelity of the sensed signals from patient 102, which may allow system 100 to more accurately determine stimulation parameters for the electrical stimulation therapy.
  • the respiration rate of patient 102 may be indicative of a severity of a condition (e.g., chronic pain) and system 100 may determine whether to deliver a more powerful electrical stimulation therapy (e.g., with a higher stimulation amplitude) to patient 102 based on the respiration rate of patient 102.
  • system 100 may adjust stimulation parameters for an electrical stimulation therapy based on the respiration rate of patient 102 to treat one or more other medical conditions and/or symptoms within a disorder, including, but is not limited to, chronic pain, epilepsy, movement disorders (e.g., Parkinson’s Disease, dystonia, or Essential Tremor), depression, stroke rehabilitation, tinnitus, migraines, autonomic dysreflexia or arthritis.
  • FIG, 2 is block diagram illustrating example configurations of implantable medical devices (IMDs) which may be utilized in the system of FIG. 1 . As shown in FIG.
  • IMD 104 includes sensing circuitry 202, sensor(s) 203, processing circuitry 204, therapy delivery- circuitry 206, switch circuitry 208, memory 2.10, telemetry- circuitry 212, and power source 214. IMD 104 may include a greater or fewer number of components. For instance, examples in which IMD 104 delivers the electrical stimulation in an openloop manner, IMD 104 may not include sensing circuitry 202.
  • Switch circuitry- 208 may be configured to, in response to instructions from processing circuitry 204, switch the coupling of one or more of electrodes 117A-D (also referred to as “electrodes 117”) between sensing circuitry 202 and therapy delivery circuitry' 206. In examples where sensing circuitry’ 202 is not used, switch circuitry 308 may not be needed. However, even in examples where sensing circuitry 202 is not used, IMD 104 may include switch circuitry 208, e.g., to disconnect electrodes 117 from therapy delivery circuitry 206.
  • therapy delivery' circuitry 206 may include a plurality of regulated current sources or sinks, with each current source or sink coupled to one of electrodes 117. In such examples, therapy delivery' circuitry- 206 may control each current source or sink and switching between electrodes 117 may not be necessary for therapydelivery since each one of electrodes 1 17 is individually controllable.
  • IMD 104 may include sensor(s) 203 configured to sense respiration of patient 102.
  • Sensor(s) 203 may include accelerometer, impedance based or ECG based sensors configured to sense respiration cycles of patient 102.
  • sensor(s) 203 include one or more other leads with sensors or electrodes disposed at a distal portion of the lead and being configured to sense signals from the body of patient 102 corresponding to the respiration cycles of patient 102.
  • IMD 104 does not include sensor(s) 203 and may instead receive sensed data corresponding to respiration of patient 102 from external programmer 130 and/or another computing device and/or sensor coupled to patient 102 (e.g., one or more patch electrodes or wearable sensors in contact with the skin of patient 102).
  • Sensor(s) 2.03 may include a motion sensor configured to sense movement of patient 102. Movement sensed sensor(s) 203 may indicate if patient 102 is having restless sleep, which may be indicative of the onset of OSA.
  • Additional examples of sensor(s) 203 may include acoustical sensors or a microphone for detecting vibrations in upper airway 12.4. Vibrations in upper airway 124 may be indicative of the onset of OSA.
  • processing circuitry' 204 may control delivery' of therapybased on information received from the one or more sensors, such as delivery of therapy- after sensing an onset of OSA.
  • electrodes 117 may be configured to sense electromyogram (EMG) signals.
  • Sensing circuitry 202 may be switchably coupled to electrodes 117 via switch circuitry 208 to be used as EMG sensing electrodes with electrodes 117 are not being used for stimulation.
  • EMG signals may’ be used by processing circuitry' 204 to detect sleep state and/or low tonal state of protrusor muscles 120 and/or 122 for use in delivering electrical stimulation.
  • processing circuitry' 204 may be used to detect sleep state and/or low tonal state of protrusor muscles 120 and/or 122 for use in delivering electrical stimulation.
  • IMD 104 may comprise any suitable arrangement of hardware, alone or in combination with software and/or firmware, to perform the techniques attributed to IMD 104 and processing circuitry 204, therapy delivery circuitry 206, and telemetry circuitry 212 of IMD 104.
  • IMD 104 may include one or more processors, such as one or more microprocessors, digital signal processors (DSPs), application specific integrated circuits (ASICs), field programmable gate arrays (FPGAs), or any other equivalent integrated or discrete logic circuitry, as well as any combinations of such components.
  • DSPs digital signal processors
  • ASICs application specific integrated circuits
  • FPGAs field programmable gate arrays
  • the various units of IMD 104 may be implemented as fixed-function circuits, programmable circuits, or a combination thereof.
  • Fixed-function circuits refer to circuits that provide particular functionality and are preset on the operations that can be performed.
  • Programmable circuits refer to circuits that can be programmed to perform various tasks, and provide flexible functionality in the operations that can be performed.
  • programmable circuits may execute software or firmware that cause the programmable c ircuits to operate in the manner defined by instructions of the software or filmware.
  • Fixed-function circuits may execute software instructions (e.g., to receive parameters or output parameters), but the types of operations that the fixed-function circuits perform are generally immutable.
  • one or more of the units may be distinct circuit blocks (fixed-function or programmable), and in some examples, one or more of the units may be integrated circuits.
  • IMD 104 may include arithmetic logic units (ALUs), elementary function units (EFUs), digital circuits, analog circuits, and/or programmable cores, formed from programmable circuits.
  • ALUs arithmetic logic units
  • EFUs elementary function units
  • memory 210 may store the instructions (e.g., object code) of the software that processing circuitry 204 receives and executes, or another memory within IMD 104 (not shown) may store such instructions.
  • IMD 104 also, in various examples, may include a memory 310, such as random access memory (RAM), read only memory (ROM), programmable read only memory (PROM), erasable programmable read only memory (EPROM), electronically erasable programmable read only memory (EEPROM), flash memory, comprising executable instructions for causing tire one or more processors to perform the actions attributed to them.
  • a memory 310 such as random access memory (RAM), read only memory (ROM), programmable read only memory (PROM), erasable programmable read only memory (EPROM), electronically erasable programmable read only memory (EEPROM), flash memory, comprising executable instructions for causing tire one or more processors to perform the actions attributed to them.
  • sensing circuitry 202, processing circuitry 204, therapy delivery circuitry 206, switch circuitry' 208, and telemetry circuitry' 212 are described as separate circuitry, in some examples, sensing circuitry 202, processing circuitry 204, therapy delivery circuitry 206, switch circuit
  • sensing circuitry 202, processing circuitry 204, therapy delivery circuitry 206, switch circuitry' 208, and telemetry' circuitry' 212 correspond to individual hardware units, such as ASICs, DSPs, FPGAs, or other hardware units.
  • Memory' 210 stores stimulation programs 216 (also called “‘therapy programs
  • stimulation parameter values e.g., therapy cycling rate, duty cycle, cycle width, stimulation amplitude, stimulation rate
  • Memory' 210 may also store instructions for execution by processing circuitry' 204, in addition to stimulation programs 216.
  • Information related to sensed parameters of patient 102 e.g., from sensing circuitry 202 or the one or more sensors of IMD 104) may be recorded for long-term storage and retrieval by a user, and/or used by processing circuitry 204 for adjustment of stimulation parameters (.
  • processing circuitry 204 is configured to adjust the therapy cycling rate, cycle -width, dutycycle, and/or cycling timing for cycles of the electrical signal based on the respiration rate of patient 102.
  • memory' 210 includes separate memories for storing instructions, electrical signal information, and stimulation programs 216.
  • processing circuitry 302 may select new stimulation parameters for a stimulation program 2.16 or new stimulation program from stimulation programs 2.16 to use in the delivery' of the electrical stimulation based on patient input and/or monitored physiological states after termination of the electrical stimulation.
  • therapy delivery' circuitry 206 generates and delivers electrical stimulation under the control of processing circuitry' 204.
  • Therapy delivery' circuitry' 206 may deliver, within an on-cycle of the electrical signal, a constant electrical signal or a plurality of electrical pulses delivered at a stimulation rate, e.g., as defined by a stimulation program 216.
  • processing circuitry- 204 controls therapydelivery' circuitry' 206 by accessing memory' 210 to selectively access and load at least one of stimulation programs 2.16 to therapy delivery circuitry 206.
  • processing circuitry 204 may access memory 210 to load one of stimulation programs 216 to therapy delivery circuitry' 206.
  • processing circuitry' 204 may access memory- 210 to load one of stimulation programs 216 to control therapy delivery circuitry 206 for delivering the electrical stimulation to patient 102.
  • a clinician or patient 102 may select a particular one of stimulation programs 216 from a list using a programming device, such as a patient programmer or a clinician programmer.
  • Processing circuitry 204 may receive the selection via telemetry- circuitry- 212.
  • Therapy delivery- circuitry 206 delivers the electrical stimulation to patient 102 according to the selected program for an extended period of time, such as minutes or hours while patient 102 is asleep (e.g., as determined from the one or more sensors and/or sensing circuitry 202).
  • processing circuitry 204 may- control switch circuitry 2.08 to couple electrodes 1 17 to therapy delivery circuitry 206.
  • Processing circuitry- 204 may select one of stimulation programs 216 based on a determination that the respiration rate of patient 102 is the same as or is within a range of respiration rates compatible with the stimulation program 216.
  • Processing circuitry 204 may then cause therapy delivery- circuitry- 206 to deliver the electrical signal to patient 102 in accordance with the stimulation parameter values stored in the stimulation program 216.
  • Therapy delivery- circuitry 206 delivers electrical stimulation according to stimulation parameter values. In some examples, therapy delivery- circuitry 206 delivers electrical stimulation during on-cycles of the cycles of the electrical signal.
  • Therapy delivery- circuitry 206 may deliver the electrical stimulation in the form of a continuous electrical signal or of a plurality- of electrical pulses.
  • Stimulation parameters may include a voltage or current amplitude, a stimulation rate , a pulse width, a duty cycle for each of a plurality electrical pulses, and/or the combination of electrodes 1 17 that therapy- deliverycircuitry 206 uses to deliver the stimulation signal during on-cycles of the electrical signal.
  • the stimulation parameters for the stimulation programs 216 may be selected to cause protrusor muscles 120 and/or 122 to an advanced state (e.g., to open-up airway 124).
  • An example range of stimulation parameters for the electrical stimulation that are likely to be effective in treating OSA are as follows: a. Stimulation Rate: between about 20 Hz and about 50 Hz, and possibly lower such as 2 Hz and 4 Hz, In some examples, the minimum target frequency is used which can achieve muscle tetany (e.g., constant contraction) and provide the required force to open the airway. b. Current Amplitude: between about 0.1 milliamps (mA) and about 20 mA, and more generally from 0.5 mA to 3 mA, and approximately 1.5 mA. c.
  • Pulse Width between about 100 microseconds (us) and about 500 ps. In some examples, a pulse width of 150 ps might be used for reduced power consumption. In some particular examples, the pulse width is approximately 240 ps. In some cases, shorter pulse widths may be used in conjunction with higher current or voltage amplitudes.
  • Therapy cycling rate about 1 cycle per minute to about 100 cycles per minute. Therapy cycling rate may be about 15 cycles per minute. The therapy cycling rate may also defined as number of on-cycles or a number of off-cycles per minute. A therapy cycling rate of 15 cycles per minute may correspond to cycles of the electrical signal with a cycle with of about 4 seconds. e.
  • Duty cycle defined as percentage of the cycle width of the on-cycle of each cycle of the electrical signal compared to a cycle width of the cycle.
  • the cycle width of a cycle may correspond to a total duration of cycle widths of the on -cycle and the off-cycle of the cycle.
  • a starting duty cycle may be 70%.
  • a therapy cycling rate of 15 cycles per minute may correspond to a cycle width of 4 seconds for each cycle.
  • the cycle width of an on-cycle of the cycle may be about 2,8 seconds and the off-cycle of the cycle may be about 1 .2 seconds based on a 70% duty cycle.
  • Processing circuitry’ 204 may select stimulation programs 216 for alternating delivery of electrical stimulation between stimulating the left pro trusor muscles 120 and/or 122 and the right protrusor muscles 120 and/or 122 on a time basis, such as in examples where two leads 106 are implanted. In some examples, there may be some overlap in the delivery of electrical stimulation such that for some of amount of time both left and right protrusor muscles 120 and/or 122 are being stimulated. In some examples, there may be a pause in alternating stimulation (e.g., stimulate left protnisor muscles, a time period with no stimulation, then stimulate right protrusor muscles, and so forth).
  • Processing circuitry 204 may also select stimulation programs 216 that select between different combinations of electrodes 117 for stimulating, such as to stimulate different locations of the hypoglossal nerve(s), which may help with fatigue as well as provide more granular control of how much to protrude tongue 118, [0089] Processing circuitry 204 may determine or receive the respiration rate of patient 102. In some examples, sensing circuitry 202 senses, via sensor) s) 203 and/or electrodes 1 17, data corresponding to respiration of patient 102 within a time period.
  • Processing circuitry 204 may retrieve the data corresponding to respiration of patient 102 within a time period from sensing circuitry 202 and determine, e.g., based on a number of detected respiration cycles and a length of the time period, a respiration rate of patient 102 for the time period. Processing circuitry 204 may retrieve, e.g., from memory 210 or from external programmer 130, a predetermined ratio of a duration of an inspiration phase to the duration of a respiration cycle. The ratio may be based on prior respiration cycles of patient 102 and/or other patients.
  • processing circuitry 204 may determine an inspiration rate and a duration of inspiration phases at the respiration rate, e.g., without measuring and determining the actual timing and duration of inspiration phases. Processing circuitry 204 may determine the rate and duration of inspiration phases without requesting, retrieving, and/or using any sensed data corresponding to the actual rate and duration of inspiration phases experienced by patient 102.
  • processing circuitry 204 may determine stimulation parameters of an electrical signal. In some examples, where processing circmin 204 selects one of stimulation programs 216, processing circuitry' 204 adjusts the stimulation parameters of the selected stimulation program 216 based on the respiration rate.
  • the stimulation parameters may correspond to the delivery' of the electrical signal at or near the hypoglossal nerve(s) and/or motor points of patient 102 during a threshold percentage of subsequent inspiration phases, e.g., such that the delivered electrical signal temporally overlaps with each of a threshold percentage of the subsequent inspiration phases by a threshold portion.
  • IMD 104 may deliver electrical signals during on-cycles of the electrical signal. The on-cycles of the electrical signal may begin and terminate at the same, similar, or different times as the subsequent inspiration phases. Nonetheless, the on-cycles of the electrical signal temporally overlap with at least the threshold portions of the threshold percentage of subsequent inspiration phases.
  • processing circuitry 204 may retrieve and apply one or more machine learning models from memory 210 to determine the stimulation parameters based on the respiration rate.
  • Each machine learning model may be trained to output values for one or more of the stimulation parameters in response to input data.
  • the input data may include sensor data (e.g., from sensor(s) 203 and/or sensing circuitry 202), the determined respiration rate of patient 102, the inspiration rate, or the like.
  • Each machine learning model may be trained via a training data set including prior values for the input data and corresponding effective stimulation parameters for patient 102 and/or one or more other patients.
  • one or more machine learning models is configured to determine the inspiration rate and/or the duration on inspiration phases based on the respiration rate. In such examples, the one or more machine learning models are trained via a training data set including prior respiration rates and the corresponding measured inspiration rates and/or the timing and duration of the corresponding inspiration phases.
  • Processing circuitry 204 may continuously or periodically monitor the respiration rate of patient 102 after the determination of the stimulation parameters. Processing circuitry' 204 may determine a change in the respiration rate by detecting a deviation from the previously determined respiration rate by a threshold amount, by calculating a current respiration rate at a separate time period and comparing the current respiration rate against the previously determined respiration rate, or the like.
  • processing circuitry- 204 may adjust values for one or more of the stimulation parameters (e.g., adjust values for the therapy cycling rate, the duty cycle, or the cycling times for the cycles of the electrical signal) and/or select another of stimulation programs 216 from memory' 210.
  • the adjusted stimulation parameters may alter the cycling timing and cycle widths of the cycles of the electrical signal (e.g., of the on-cycles of the electrical signal).
  • the adjusted stimulation parameters may cause the electrical stimulation therapy to maintain efficacy, e.g., by causing therapy- delivery circuitry-' 206 to deliver electrical signals at or near the hypoglossal nerve(s) and/or motor points of patient 102 during the adjusted on-cycles of the electrical signal for the threshold percentage of subsequent inspiration phases when patient 102 is respirating at the adjusted respiration rate.
  • processing circuitry 204 may adjust the stimulation parameters and/or select another stimulation program 216 based on a determination that under the current stimulation parameters, the on-cycles of electrical signals temporally overlap with less than the threshold percentage of subsequent inspiration phases when patient 102 is respirating at the adjusted respiration rate.
  • processing circuitry 204 maintains the current values for the stimulation parameters based on a determination that there is no loss of efficacy when patient 102 is respirating at the adjusted respiration rate,
  • Processing circuitry 204 may predict, e.g., based on the prior sensed data retrieved by processing circuitry 204, a predicted respiration rate based on trends in the changes in the respiration rate. In some examples, processing circuitry 204 may input the prior sensed data and/or the prior determined respiration rates into a machine learning model trained to predict a respiration rate. Processing circuitry 204 may adjust the stimulation parameters based on the predicted respiration rate, e.g., to preempt upcoming changes in tire respiration rate of patient 102 and increase efficacy of the OSA therapy. Processing circuitry 204 may store the adjusted stimulation parameters in memory' 210 (e.g., as a new stimulation program 216, as updated stimulation parameter values to an existing stimulation program 216).
  • memory' 210 e.g., as a new stimulation program 216, as updated stimulation parameter values to an existing stimulation program 216.
  • processing circuitry 204 selects a new stimulation program 216 from memory 210 based on the future respiration rate. Processing circuitry' 204 may cause therapy delivery circuitry 206 to immediately deliver the electrical stimulation therapy in accordance with the adjusted stimulation parameters or the new stimulation program 216. In some examples, processing circuitry 204 causes therapy delivery' circuitry 206 to deliver the electrical stimulation therapy in accordance with the adjusted stimulation parameters or the new' stimulation program 216 based on a determination that patient 102 is currently' respirating at the predicted respiration rate.
  • therapy delivery circuitry' 206 drives electrodes 117 of lead 106.
  • therapy delivery circuitry 206 delivers electrical signals (e.g., regulated current or voltage electrical pulses at stimulation rates and pulse widths described above) to tissue of patient 102. via selected electrodes 1 17 A- 117D earned by lead 106.
  • a proximal end of lead 106 extends from the housing of IMD 104 and a distal end of lead 106 extends to a target therapy site, e.g., through inner lumen of the needle.
  • Target therapy sites may include one or both hypoglossal nerves and/or motor points.
  • Therapy delivery circuitry 206 may deliver electrical signals with electrodes on more than one lead and each of the leads may carry one or more electrodes, such as when patient 102 is implanted with two leads 106 in tongue 118 for stimulating both hypoglossal nerves simultaneously or bilaterally (e.g., one after the other) or for stimulating multiple motor points simultaneously.
  • the leads may be configured as an axial lead with ring electrodes or segmented electrodes and/or paddle leads with electrode pads arranged in a two- dimensional array.
  • the electrodes may operate in a bipolar or multi-polar configuration with other electrodes, or may operate in a monopolar configuration referenced to an electrode carried by the device housing or “can” of IMD 104.
  • processing circuitry 204 may control therapy delivery circuitry’ 206 to deliver or terminate the electrical stimulation based on patient input received via telemetry circuitry 212.
  • Telemetry' circuitry 212 includes any suitable hardware, firmware, software, or any combination thereof for communicating with another device, such as an external programmer. Under the control of processing circuitry 204, telemetry' circuitry' 212 may receive downlink telemetry' (e.g., patient input) from and send uplink telemetry' (e.g., an alert) to a programmer with the aid of an antenna, which may be internal and/or external. Processing circuitry 204 may provide the data to be uplinked to the programmer and the control signals for telemetry circuitry 2.12 and receive data from telemetry- circuitry' 212.
  • downlink telemetry' e.g., patient input
  • uplink telemetry' e.g., an alert
  • Processing circuitry 204 may provide the data to be uplinked to the programmer and the control signals for telemetry circuitry 2.12 and receive
  • processing circuitry 204 controls telemetry circuitry 212 to exchange information with a medical device programmer and/or another device external to IMD 104. Processing circuitry' 204 may transmit operational information and receive stimulation programs or stimulation parameter adjustments via telemetry' circuitry' 212. Also, in some examples, IMD 104 may communicate with other implanted devices, such as stimulators, control devices, or sensors, via telemetry' circuitry 212.
  • Power source 214 delivers operating power to the componen ts of IMD 104.
  • Power source 214 may include a battery- and a power generation circuit to produce the operating power.
  • the battery' may be rechargeable to allow' extended operation. Recharging may- be accomplished through proximal inductive interaction between an external charger and an inductive charging coil w'ithin IMD 104.
  • an external inductive power supply may transcutaneously power IMD 104 whenever electrical stimulation is to occur,
  • FIG. 3 is a block diagram illustrating an example configuration of an external programmer 130. While programmer 130 may generally be described as a hand-held computing device, programmer 130 may be a notebook computer, a cell phone, or a workstation, for example. As illustrated in FIG. 3, external programmer 130 may include processing circuitry' 302, memory' 304, user interface 306, telemetry circuitry' 308, and power source 210.
  • programmer 130 comprises any' suitable arrangement of hardware, alone or in combination with software and/or firmware, to perform the techniques attributed to programmer 130, and processing circuitry- 302, user interface 306, and telemetry circuitry 308 of programmer 130.
  • processing circuitry 302 may include one or more processors, such as one or more microprocessors, DSPs, ASICs, FPGAs, or any other equivalent integrated or discrete logic circuitry', as well as any combinations of such components.
  • Examples of memory 304 may include RAM, ROM, PROM, EPROM, EEPROM, flash memory, a hard disk, a CD-ROM, comprising executable instructions for causing the one or more processors to perform the actions attributed to them.
  • processing circuitry 302 and telemetry circuitry- 308 are described as separate circuitry', in some examples, processing circuitry 302 and telemetry- circuitry' 308 are functionally integrated. In some examples, processing circuitry 302 and telemetry circuitry' 308 correspond to individual hardware units, such as ASICs, DSPs, FPGAs, or other hardware units.
  • memory 304 may' further include program information (e.g., stimulation programs) defining the electrical stimulation, similar to those stored in memory- 210 of IMD 104.
  • the stimulation programs stored in memory' 304 may be downloaded into memory 210 of IMD 104.
  • User interface 306 may include a button or keypad, lights, a speaker for voice commands, a display, such as a liquid crystal (LCD), light-emitting diode (LED), or cathode ray tube (CRT).
  • a display such as a liquid crystal (LCD), light-emitting diode (LED), or cathode ray tube (CRT).
  • the display may be a touch screen.
  • processing circuitry 302 may present and receive information relating to electrical stimulation and resulting therapeutic effects via user interface 306.
  • processing circuitry 302 may receive patient input via user interface 306. The input may be, for example, in the form of pressing a button on a key-pad or selecting an icon from a touch screen.
  • Processing circuitry 302 may also present information to the patient in the form of alerts related to delivery of the electrical stimulation to patient 102 or a caregiver via user interface 306.
  • programmer 130 may additionally or alternatively include a data or network interface to another computing device, to facilitate communication with the other device, and presentation of information relating to the electrical stimulation and therapeutic effects after termination of the electrical stimulation via the other device.
  • processing circuitry 302 retrieves sensor data corresponding to respiration by patient 102 and determines the respiration rate and stimulation parameters of the electrical stimulation therapy, e.g., in a same manner as previously described with respect to processing circuitry 204 of FIG. 2.
  • Telemetry circuitry’ 308 supports wireless communication between IMD 104 and programmer 130 under the control of processing circuitry' 302. Telemetry- circuitry- 308 may also be configured to communicate with another computing device via wireless communication techniques, or direct communication through a wired connection. In some examples, telemetry circuitry- 308 may- be substantially similar to telemetry' circuitry- 212 of IMD 104 described above, providing wireless communication via an RF or proximal inductive medium. In some examples, telemetry circuitry 308 may include an antenna, which may take on a variety of forms, such as an internal or external antenna.
  • Examples of local wireless communication techniques that may be employed to facilitate communication between programmer 130 and another computing device include RF’ communication according to the 802.11 or Bluetooth specification sets, infrared communication (e.g., according to the IrDA standard), or other standard or proprietary- telemetry- protocols. In this manner, other external devices may be capable of communicating with programmer 130 without needing to establish a secure wireless connection.
  • RF radio frequency
  • FIG. 4 is a chart 400 illustrating example respirator ⁇ ' phases within respiration cycles 401 A-C of patient 102 (collectively referred to as “respiration cycles 401”). Respiration of patient 102 occurs in the form of a plurality of respiration cycles 401 . Hie plurality of respiration cycles 401 may define a respiration rate 406. Respiration rate 406 may correspond a number of respiration cycles within a time period.
  • respiration rate 406 corresponds to three respiration cycles 401 within the time period.
  • Each respiration cycle 401 is temporally adjacent to two other respiration cycles 401.
  • Respiration cycles 401 may be represented by changes in air flow' 402 (e.g., in meters per second (m/s)) over time 404 (e.g,, in seconds (s)).
  • Respiration cycle 401 may be separated into inspiration phases 408A-408C (collectively referred to as “inspiration phases 408”) and expiration phases 410A--410C (collectively referred to as “expiration phases 410”) temporally adjacent to and following each of inspiration phases 408.
  • Inspiration phases 408 may be represented on chart 400 as a positive flow' of air into patient 102 (e.g., via positive air flow 402).
  • expiration phases 410 patient 102 exhales air from the lungs of patient 102 via airway 124.
  • Expiration phases 410 may be represented on chart 400 as a negative flow of air (e.g., via negative air flow 402).
  • each inspiration phase 408 may have a same or different duration as inspiration phases 408 of one or more prior respiration cycles 401.
  • each expiration phase 410 may have a same or different duration as expiration phases 410 of one or more prior respiration cycles 401.
  • a duration of each respiration cycle 401 corresponds to a combined duration of the respective inspiration phase 408 and expiration phase 410 of the respiration cycle 401 .
  • a duration of respiration cycle 401 A is a total duration of inspiration phase 408A and expiration phase 410A. Changes in the duration of inspiration phases 408 and/or of expiration phases 410 may alter the duration of the corresponding respiration cycle 401.
  • Respiration rate 406 of patient 102 may correspond to a number of respiration cycles 401 over a fixed time period.
  • IMD 104 and/or external programmer 130 may determine respiration rate 406 of patient 102 by identifying, within a data set sensed by or received by IMD 104 and/or external programmer 130, a number of respiration cycles 401 within fixed time period.
  • IMD 104 and/or external programmer 130 may determine respiration rate 406 of patient 102 by identifying an amount of time 404 for patient 102 to undergo a specific number of respiration cy cles 401.
  • IMD 104 and/or external programmer 130 may continuous or periodically monitor the respiration cycles 401 and respiration rate 406 and may identify trends or changes in respiration rate 406 over time 404. Changes in the duration of inspiration phase 408 and/or expiration phase 410 within specific respiration cycles 401 (e.g., within respiration cycle 401C) may not significantly alter respiration rate 406 of patient 102. In some examples, the duration of inspiration phase 408 and/or expiration phase 410 within a single respiration cycle 401 can alter from the duration of the respiration phases of prior respiration cycles 401 and represents a localized change in the duration of the respiration phases of respiration cycles 401. By determining stimulation parameters based on respiration rate 406 rather than based on the duration of inspiration phases 408, system 100 may be resistant to make unnecessary alterations to the stimulation parameters based on localized changes in tire durations of respiration phases of respiration cycles 401.
  • FIG. 5A is a chart, illustrating example timing diagrams 500A and 500B of the delivery of OSA therapy by system 100 of FIG. 1.
  • respiration rate 406 may change over time to respiration rate 512.
  • System 100 may adjust the OSA therapy from delivering electrical signals during on-cycles 504 of cycles 507 defined by a first therapy cycling rate 503 A to delivering electrical signals during on- cycles 514 of cycles 520 defined by a second therapy cycling rate 503B.
  • Timing diagram 500A illustrates a first OSA therapy defining a plurality of cycles 507.
  • Therapy cycling rate 503A may define a number of stimulation cycles 507 over a period of time 404.
  • Each cycle 507 may include an on-cycle 504 and an off-cycle 508.
  • On-cycle 504 may define a cycle width 506
  • Cycle width 506 may be defined by a duty cycle of cycle 507.
  • the duty cycle 507 may represent a ratio of cycle wid th 506 to the total cycle width of cycle 507 (e.g., a sum of cycle width 506 and a cycle width of off-cycle 508. While FIG. 5A illustrates cycles 507 defining a 50% duty cycle (e.g., where cycle width 506 is equal to a cycle width of off-cycle 508), other example cycles 507 may define duty cycles of up to about 80% (e.g., a duty cycle of 70%).
  • Therapy cycling rate 503A may define to a number of cycles 507 (within a time period.
  • the cycle widths of cycles 507 may correspond to therapy cycling rate 503A, For example, a longer cycle 507 corresponds to a lower therapy cycling rate 503A and vice versa.
  • System 100 e.g., IMD 104 and/or external programmer 130
  • System 100 may determine cycle widths 506 of on-cycles 504 based on therapy cycling rate 503A and/or the duty cycle for cycles 507.
  • system 100 may deliver electrical signals during on- cycles 504 at a constant therapy cycling rate 503 A over time 404.
  • system 100 determines the duty cycle for cycles 507 based on respiration rate 406 and determines cycles widths 506 of on-cycles 504 and the cycle widths of off-cycles 508 based on therapy cycling rate 503A and the duty cycle of cycles 507.
  • system 100 may deliver electrical signals during on-cycles 504 coinciding wi th inspiration phases 408 of respiration cycles 401, e.g., such that cycle widths 506 of on-cycles 504 temporally overlaps at least a threshold portion of at least a threshold percentage of inspiration phases 408 of the respiration of patient 102 (e.g., 80 %, 85%, 90%) when patient 102 respirates at respiration rate 406.
  • Pulses 504 may temporally overlap with at least 50% of each of a threshold percentage of inspiration phases 408.
  • the cycling timing of on-cycles 504 (e.g., a start time of each on-cycle 504, an end time of each on- cycle 504) is independent of the timing of inspiration phases 408 of respiration cycles 401 .
  • temporally overlapping on-cycles 504 and inspiration phases 408 may begin and/or end at the same or at different times.
  • system 100 may determine the stimulation parameters (e.g., therapy cycling rate 503 A, cycle width 506, duty cycle of cycles 507) such that on-cycles 504 temporally overlaps with at least the threshold portion of inspiration phases 408.
  • 401 maycause a change in the timing of respiration cycles 401 relative to the timing of cycles 507 of the electrical signal.
  • on-cycles 504 may still temporally overlap with at least the threshold portion of the threshold percentage of inspiration phases 408 following changes 510.
  • Changes 510 may not be indicative of larger scale changes in respiration cycles 401 (e.g., over minutes, hours) and may correspond to changes in a small number of respiration cycles 401.
  • system 100 m ay continue to deliver electrical signal during on-cycles 504 of cycles 507 defined at therapy cycling rate 503A and/or having the duty cycles to patient 102.
  • localized changes 510 may correspond to changes in the respiration of patient 102 from respiration cycles 401 at respiration rate 406 to respiration cycles 502 at respiration rate 512.
  • respiration rate 512 may be greater than respiration rate 406, e.g., such that durations of respiration cycles 512 are greater than the durations of respiration cycles 401
  • respiration rate 512 may be less than respiration rate 406, e.g., such that durations of respiration cycles 512 are less than the durations of respiration cycles 401.
  • System 100 may in response to detecting or receiving sensor data indicating the change to respiration rate 512, adjust therapy cycling rate 503 A to therapy cycling rate 503B, as illustrated in timing diagram 500B.
  • Therapy cycling rate 503B may define a number of stimulation cycles 520 over a period of time 404, each stimulation cycle 520 including an on-cycle 514 of cycle width 518 and an off-cycle 516. Cycles 520 may define a duty cycle representing a ratio of cycle width 518 to the cycle width of cycle 520. In some examples, as illustrated in timing diagram 500B, therapy cycling rate 503B may be less than therapy cycling rate 503A. In such examples, cycle widths 518 may be less than cycles widths 506 and the duration of stimulation cycles 520 may be less than the duration of stimulation cycles 507. In other examples, therapy cycling rate 503B may be greater than therapy cycling rate 503A.
  • Cycles 507, 520 may define the same or different duty cycles.
  • System 100 may adjust the duty cycle of cycle 520 based on the determined change in the respiration rate.
  • System 100 may continuously or periodically monitor the respiration rate (e.g., respiration rate 406) of patient 102 and may identify changes in the respiration rate of patient 102 to respiration rate 512. As a part of the change in the respiration rate to respiration rate 512, durations of respiration cycles 502 are al tered relative to duration of respiration cycles 401 at a prior respiration rate 406. For example, relative to respiration rate 406 of timing diagram 500A, respiration rate 512 as illustrated in timing diagram 500B is higher than respiration rate 406, e.g., patient 102 undergoes respiration cycles 502 within a shorter period of time 404 than respiration cycles 401 . In other examples, respiration rate 512 may be lower than respiration rate 406.
  • respiration rate e.g., respiration rate 406
  • System 100 may determine changes in the respiration rate to respiration rate 512 based on changes m the duration of respiration cycles 401 over a fixed time period, based on changes in the duration of a threshold number of consecutive respiration cycles 401 (e.g., of three or more consecutive respiration cycles, of four or more consecutive respiration cycles), based on a comparison between a prior determined respiration rate (e.g., respiration rate 406) and a current respiration rate (e.g., respiration rate 512), or any other means or process for detecting changes in the respiration rate of patient 102.
  • a threshold number of consecutive respiration cycles 401 e.g., of three or more consecutive respiration cycles, of four or more consecutive respiration cycles
  • a prior determined respiration rate e.g., respiration rate 406
  • a current respiration rate e.g., respiration rate 512
  • delivering electrical signals during on-cycles 504 may be less efficacious at treating OSA, e.g., on- cycles 504 no longer temporally overlap with the threshold portion of the threshold percentage of inspiration phases 408 when patient 102 respirates at respiration rate 512.
  • system 100 may adjust or change stimulation parameters to define cycles 520 at therapy delivery' rate 503B.
  • Therapy delivery- rate 503B may define on-cycles
  • the electrical signals delivered during on-cycles 504, 514 may have same stimulation parameters (e.g., the electrical signals may be constant electrical signals at a same amplitude, or may- be a plurality of electrical pulses at a same stimulation rate) or may be different types of electrical signals (e.g., may be constant electrical signals at different amplitudes, may be pluralities of electrical pulses with different stimulation rates).
  • cycle width 506 is different from cycle width 518
  • IMD 104 may deliver a different number of electrical pulses during each on-cycle 504 than during each on-cycle 514 even though the electrical pulses are delivered at a same stimulation rate. For example, if cycle width 506 is greater than cycle width 518, IMD 104 may deliver more electrical pulses at the same stimulation rate during on-cycles 504 than during on-cycles 514, and vice versa.
  • the adjusted stimulation parameters may be configured to time on-cycles 514 to temporally overlap at least the threshold portion of each inspiration phase 408 of the threshold percentage of inspiration phases 408 when patient 102 respirates at respiration rate 512.
  • System 100 may, in accordance with the adjusted stimulation parameters, electrical signals at a faster or slower therapy cycling rate 503B than therapy cycling rate 503A and/or deliver electrical signals within on-cycles 514 with longer or shorter cycle widths 518 than on-cycles 504.
  • system 100 determines an increase in the respiration rate and increases the therapy cycling rate from therapy cycling rate 503A to therapy cycling rate 503B and/or increase the duty cycle to increase the cycle width of on-cycles from cycle width 506 to cycle width 518 without changing the overall cycle width of cycles 507.
  • system 100 determines an decrease in the respiration rate and decreases the therapy cycling rate from therapy cycling rate 503A to therapy cycling rate 503B and/or reduce the duty cycle to decrease the cycle width of on- cycles from cycle width 506 to cycle width 518 without changing the overall cycle width of cycles 507.
  • system 100 may select another stimulation program 216 that corresponds to respiration rate 512. System 100 may then deliver the pulses of electrical signal to patient 102 in accordance with stimulation parameters of tire new stimulation program 216.
  • system 100 may include an implantable medical device (IMD) 104 configured to deliver an electrical signal at or near a hypoglossal nerve of a patient 102 to treat obstructive sleep apnea (OSA), one or more sensors (e.g., sensor(s) 203), and processing circuitry (e.g., processing circuitry 204, 302) in communication with the IMD 104 and the one or more sensors.
  • IMD implantable medical device
  • OSA obstructive sleep apnea
  • processing circuitry e.g., processing circuitry 204, 302
  • the processing circuitry may be configured to receive, via the one or more sensors, a data set corresponding to respiration of the patient during a time period; determine, based on the received data, a respiration rate 406 of the patient 102 over the time period; and determine, based on the respiration rate 406, a therapy cycling rate 503 A of the electrical signal, therapy cycling rate 503 A may define a frequency of a plurality of cycles 507 of the electrical signal, wherein at the frequency, on- cycles 504 of the plurality of cycles 507 overlap at least a threshold percentage of subsequent inspiration phases 408 when the electrical signal is delivered at therapy cycling rate 503A.
  • the processing circuitry may cause the IMD 104 to deliver the electrical signal at or near the hypoglossal nerve at therapy cycling rate 503 A.
  • FIG. 5B is a chart illustrating example on-cycles and off-cycles of an example timing diagram 500B of FIG. 5A.
  • system 100 may adjust therapy cycling rate 503A to therapy cycling rate 503B in response to determined changes 510 in the respiration rate of patient 102.
  • Each of therapy' cycling rate 503A, 503B may define a frequency of stimulation cycles (e.g., cycles 507, 520).
  • Each stimulation cycle may define an on-cycle and an off-cycle.
  • each cycle 507 defines an on-cycle 504 and an off-cycle 508 and each cycle 520 defines an on-cycle 514 and an off-cycle 516.
  • Therapy cycling rates 503A, 503B may define a cycle width for cycles 507, 520, respectively.
  • the cycle widths of on-cycles and off-cycles for each cycle 507, 520 may be defined by the respective cycle width and duty cycle for cycle 507, 520.
  • system 100 delivers a plurality' of electrical pulses 524 at stimulation rate 530 during each on-cycle (e.g., during on-cycles 504, 514).
  • Tlie plurality of electrical pulses 524 may stimulate tongue 118 to cause tongue 118 to extend to an advanced state and open up airway 12.4.
  • the plurality of electrical pulses 524 may be separated by recovery' periods 526. Delivering electrical pulses 524 separated by recovery- periods 526 may reduce an amount of power required for system 100 to cause tongue 118 to maintain the advanced state during an on-cycle, e.g., as compared to delivering a constant electrical signal during an on-cycle.
  • System 100 may define a plurality of electrical cycles 528, each electrical cycle 528 including an electrical pulse 524 and a corresponding recovery period 526 following the electrical pulse 524.
  • Stimulation rate 530 may define a number of electrical cycles 528 over a period of time 404 , The duration of electrical cycles 528 may be defined by stimulation rate 530.
  • a stimulation rate 530 of 20 Hz may correspond to a duration of 0.05 seconds for each electrical cycle 528.
  • the pulse width of electrical pulses 524 and the duration of recovery periods 526 relative to the duration of electrical cycle 528 may be defined by a duty cycle of electrical cycle 528.
  • a duty cycle of 50% for electrical cycle 528 with stimulation rate 530 of 20 Hz may correspond to a pulse width of 0.025 seconds for electrical pulse 52.4 and a duration of 0.025 seconds for recover ⁇ -' periods 52.8.
  • System 100 may deliver electrical pulses 524 at a constant stimulation rate 530 across multiple on-cycles 504, 514.
  • a number of electrical pulses 524 delivered during each on-cycle 504, 514 may be dependent on cycle widths 506, 518 of each respective on-cycle 504, 514.
  • system 100 may adjust therapy cycling rate 503A to therapy cycling rate 503B, which may adjust cycle widths 506 of on-cycles 504 to cycle widths 514 of on-cycles 514.
  • system 100 may adjust duty cycles of cycles 507 and adjust cycle widths 506 to cycle widths 518.
  • system 100 may continue to deliver electrical pulses 524 at a same stimulation rate 530 as during on-cycles 504 of cycles 507.
  • system 100 may deliver more or fewer electrical pulses 524 during on-cycles 514 while still delivering electrical pulses 524 at the same stimulation rate 530. For example, where cycle width 518 is greater than cycle width 506, as illustrated in FIG. 5B, system 100 may deliver more electrical pulses 524 at the same stimulation rate 530. In some examples, where cycle width 518 is less than cycle width 506, system 100 may deliver fewer electrical pulses 524 at the same stimulation rate 530.
  • system 100 may deliver the same number of electrical pulses 524 during on-cycles 514 of adjusted cycles 520.
  • FIG. 6 is a flow diagram illustrating an example process of delivering OSA therapy to patient 102. While the example process of FIG, 6 is primarily described with respect to IMD 104 of system 100 of FIG. 1, the example process described herein may be performed by external programmer 130 and/or another computing device, computing system, or cloud computing environment in communication with IMD 104 of system 100. While the example process of FIG.
  • system 100 to deliver electrical stimulation therapy to patient 102 to treat OSA
  • the example process illustrated herein may be used by system 100 to deliver electrical stimulation therapy to patient 102 to treat one or more other conditions and/or symptoms to medical conditions, including, but is not limited to, chronic pain, epilepsy, movement disorders (e.g., Parkinson’s Disease, dystonia, or Essential Tremor), depression, stroke rehabilitation, tinnitus, migraines, autonomic dysreflexia or arthritis.
  • movement disorders e.g., Parkinson’s Disease, dystonia, or Essential Tremor
  • depression e.g., depression
  • stroke rehabilitation e.g., tinnitus
  • migraines e.g., migraines, autonomic dysreflexia or arthritis.
  • System 100 may receive a data set corresponding to respiration of patient 102 during a time period (602). Tire time period may be predetermined and may be a specific number of seconds, minutes, hours, or the like.
  • Sensing circuitry’ 202 may’ sense, e.g., via sensor(s) 203 and/or one or more of electrodes 117 disposed on a lead 106 coupled to IMD 104, signals corresponding to respiration of patient 102 (e.g., corresponding to respiration cycles 401 of patient 102).
  • Sensing circuitry 2.02 may then transmit the sensed signals to processing circuitry 204 as a part of the data set.
  • Sensor(s) 203 may’ be coupled to patient 102 (e.g., may be a patch electrode placed on the skin of patient 102 and configured to communicate with IMD 104) or may be disposed within the housing of IMD 104.
  • Sensor(s) 203 may include accelerometers, impedance sensors, strain gauges or the like. Sensor(s) 203 may sense movement of the torso of patient 102 and/or other signals corresponding to respiration by patient 102.
  • processing circuitry 204 receives the data set from another sensor coupled to patient 102 via telemetry circuitry 212.
  • System 100 may determine, based on the data set, a respiration rate (e.g., respiration rate 406) of patient 102 over the time period (604).
  • Processing circuitry' of system 100 e.g., processing circuitry 204, processing circuitry 302 may determine, within the received data set, signals or patterns of signals corresponding to complete respiration cycles 401 of patient 102.
  • Tire processing circuitry may then determine respiration rate 406 of patient 102 based on a number of complete respiration cycles 401 within a fixed time period and/or based on an amount of time for patient 102 to undergo a specific number of respiration cycles 401 , Respiration rate 406 may be represented in terms of a number of cycles per a unit of time (e.g., cycles per minute, cycles per hour, or the like). Each respiration cycle 401 may be separated into respiratory phases including an inspiration phase 408, corresponding to inhalation by patient 102, and an expiration phase 410, corresponding to exhalation by patient 102. System 100 may not calculate the timing and duration of each inspiration phase 408 or each expiration phase 410. Tire sensed signals within the received data set may be insufficient for system 100 to determine tire timing and duration of inspiration phases 408 or of expiration phases 410 of respiration cycles 401.
  • System 100 may determine, based on respiration rate 406, a therapy cycling rate (e.g., therapy cycling rate 503A) of the electrical signal (606).
  • Therapy cycling rate 503A may represent a frequency of cycles 507 over time.
  • Each cycle 507 may include an on-cycle 504 and an off-cycle 508.
  • IMD 104 may deliver electrical signals during on- cycles 504 of cycles 507 to treat OSA to tissue of patient 102, e.g., at or near hypoglossal nerve(s) and/or motor points in tongue 118 of patient 102.
  • the electrical signals may be a constant electrical signal or may be a plurality of electrical pulses 524 delivered at stimulation rate 530.
  • System 100 may receive or retrieve, e.g., from memory 210, 304, threshold conditions corresponding to efficacious deli very of the electrical stimulation therapy and may determine therapy cycling rate 503A such that IMD 104 delivers the electrical signal at correct intervals to patient 102 to satisfy the threshold conditions.
  • the threshold conditions may include but are not limited to, temporal overlap, by on-cycles 504 of cycles 507, of a threshold portion of each of a threshold percentage subsequent inspiration phases.
  • Tire threshold portion of each inspiration phase 408 of the threshold percentage of inspiration phases 408 may represent a portion (e.g., in terms of a ratio of a percentage) of a duration of each inspiration phase 408 during which IMD 104 delivers the electrical signal to tissue of patient 102,
  • on-cycles 504 may temporally overlap with at least 50% of the duration of each inspiration phase 408 within the threshold percentage of inspiration phases 408.
  • the threshold percentage of inspiration phases 408 may represent a target percentage of inspiration phases 408 within all subsequent inspiration phases 408.
  • System 100 may determine, e.g., based on predetermined ratios or percentages, a portion or ratio of each respiration cycle 401 corresponding to respective inspiration phases 408 of each respiration cycle 401.
  • the predetermined ratio or percentage may be based on data corresponding to prior respiration cycles 401 by patient 102 and/or by one or more other patients.
  • system 100 may estimate the timing and/or rate of inspiration phases 408 without actually measuring the timing of inspiration phases 408.
  • system 100 may determine a therapy cycling rate 503A and a duty cycle for cycles 507 such that the on-cycles 504 satisfy the threshold conditions given respiration rate 406 and the determined proportionality of inspiration phases 408.
  • the duty cycle may correspond to a ratio of the cycle width 506 of each on- cycle 504 to a duration of cycle 507.
  • On-cycles 504 may begin and end at different times than the respective inspiration phases 408 but may nonetheless satisfy the threshold condition (e.g., may temporally overlap with at least the threshold portion of each inspiration phase of the threshold percentage of subsequent inspiration phases).
  • Therapy cycling rate 503A is independent of the actual timing of respiratory phases (e.g., timing of inspiration phases) of the respiration of patient 102 and is dependent on respiration rate 406 of patient 102.
  • system 100 may determine other stimulation parameters, e.g., cycle widths 506 of on-cycles 504 and/or duty cycles of cycles 507.
  • System 100 may characterize the timing and duration of on-cycles 504 in terms of two or more stimulation parameters such as two or more of therapy cy cling rate 503 A, cycle widths 506, and/or the duty cycles of cycles 507.
  • Cycle widths 506 may represent a duration of the active delivery of the electrical signal within each on-cycle 504 and the duty cycle may represent the ratio of the active delivery of the electrical signal to the entire duration of cycle 507 (e.g., including off-cycle 508 for each cycle 507).
  • System 100 may deliver the electrical signal at or near the hypoglossal nerve of patient 102 at therapy cycling rate 503 A (608).
  • IMD 104 may deliver, e.g., via electrodes 1 17, the electrical signal at or near hypoglossal nerve(s) and/or motor points within tongue 118 at a frequency corresponding to therapy cycling rate 503 A (e.g., during on-cycles 504 of cycles 507 defined by therapy cycling rate 503A).
  • Each electrical signal may include characteristics defined by one or more other stimulation parameters (e.g., stimulation rate 530 for electrical pulses 524, pulse amplitude, etc.).
  • IMD 104 may deliver, during each on- cycle 504, a single constant electrical signal or a plurality of electrical pulses 524.
  • Electrical pulses 524 may be delivered at a stimulation rate 530 to elicit a sustained muscle contraction within tongue 1 18 of patient 102 during on-cycle 504.
  • IMD 104 is delivering electrical signals during on-cycles 504 at or near hypoglossal nerve(s) and/or motor points of patient 102, the timing of each on-cycle 504 may be independent of a respective inspiration phase 408 of respiration of patient 102.
  • the disclosure describes a method for treating obstructive sleep apnea (OSA) including: sensing, via one or more sensors of a medical system 100, a data set corresponding to respiration of a patient 102 during a time period; determining, by processing circuitry (e.g., processing circuitry 204, 302) of the medical system 100 and based on the data set, a respiration rate 406 of the patient 102 over the time period; determining, by the processing circuitry 204, 302 and based on the respiration rate 406, a therapy cycling rate 503A of the electrical signal.
  • OSA obstructive sleep apnea
  • FIG. 7 is a flow diagram illustrating another example process of delivering OSA therapy to patient 102.
  • System 100 may determine, based on a first data set, a first respiration rate 406 of patient 102 over a first time period (702).
  • System 100 may sense, detect, or receive sensor data (e.g., from sensor(s) 203 within IMD 104, from one or more of electrodes 117, from one or more sensors coupled to patient 102 and in communication with IMD 104 and/or external programmer 130 of system 100, etc.) corresponding to respiration of patient 102.
  • Tire sensor data may be contained or packaged within the first data set.
  • system 100 may determine the first respiration rate 406 corresponding to the respiration of patient 102 over the first time period, as recorded in the sensor data.
  • System 100 may determine, based on the first respiration rate 406, a first therapy cycling rate 503A (704). System 100 may determine first therapy cycling rate 503A, e.g,, in accordance with the techniques and/or processes previously described above with respect to FIGS. 1-6. System 100 may then deliver an electrical signal at or near hypoglossal nerve(s) of patient 102 at first therapy cycling rate 503A (706). In some examples, IMD 104 may deliver , during on-cycles 504 of cycles 507 defined by threapy cycling rate 503A, the electrical signal at or near hypoglossal nerve(s) of patient 102. via one or more of electrodes 117.
  • system 100 may determine one or more other stimulation parameters (e.g., a duty cycle of cy cles 507) in addition to first therapy cycling rate 503 A and cause IMD 104 to deliver electrical signals during on-cycles 504 as defined by the one or more other stimulation parameters.
  • other stimulation parameters e.g., a duty cycle of cy cles 507
  • System 100 may determine, based on a second data set, a change in the respiration rate of patient 102 to a second respiration rate 512 over a second time period (708).
  • System 100 may continuously monitor respiration of patient 102 (e.g., from the beginning of the first time period to the end of the second time period), and detect a change from first respiration rate 406 to second respiration rate 512 based on a determination that a plurality of respiration cycles 502 during the second time period defines the second respiration rate 512.
  • the second data set may correspond to sensor data sensed, received, or otherwise obtained by system 100 during the second time period immediately following the first period.
  • system 100 periodically determines the respiration rate of patient 102 over a second time period temporally separated from the first time period. System 100 may then compare second respiration rate 512 with first respiration rate 406 to determine any changes in the respiration rate from first respiration rate 406 to second respiration rate 512.
  • System 100 may determine the change from first respiration rate 406 to second respiration rate 512 based on sensed data over the second time period.
  • System 100 may be resistant to determine a change to second respiration rate 512 based on localized changes in the duration of specific respiration cycles and/or the timing and duration of specific respiratory phases.
  • System 100 may determine whether delivering the electrical signal at first therapy cycling rate 503 A maintains efficacy of the OSA therapy at second respiration rate 512 (710).
  • System 100 may determine the efficacy of the delivery of the electrical signal by determining whether the electrical signals are delivered during a threshold percentage of inspiration phases 408 when patient 102 respirates (e.g., when patient 102 respirates at first respiration rate 406, when patient 102 respirates at the second respiration rate 512, etc.) Since the therapy cycling rate 503A is independent from the actual timing of inspiration phases during respiration by patient 102, changes in the respiration rate may change the timing of inspiration phases relative to the timing of on-cycles 504 of cycles 507, which may affect the percentage of inspiration phases affected by the electrical signals delivered during on-cycles 504. Reduction of the percentage of inspiration phases affected by the delivered electrical signals to less than the threshold percentage may correspond to a reduction in efficacy of the OSA therapy.
  • system 100 determines a reduction in efficacy of the OSA therapy based on a determination that on-cycles 504 temporally overlap less than threshold percentage of subsequent inspiration phases by a at least a threshold portion when patient 102 respirates at second respiration rate 512. In some examples, system determines that efficacy of the OSA therapy is maintained based on a determination on-cycles 504 temporally overlap at least a threshold portion of at least the threshold percentage of subsequent inspiration phases when patient 102 respirates at second respiration rate 512.
  • system 100 may continue to monitor the respiration rate of patient 102 over a time period (702), e.g., without adjusting any stimulation parameters such as therapy cycling rate 503 A and/or the duty cycles of cycles 507.
  • system 100 may determine a second therapy cycling rate 503B based on second respiration rate 512 (712). In some examples, system 100 adjusts the duty cycle of cycles 507 to lengthen or reduce cycle widths 506 of on-cycles 504 to maintain efficacy.
  • Second therapy cycling rate 503B may define a a rate of delivery of cycles507 of the electrical signal.
  • the electrical signals satisfy the threshold condition w hen patient 102 respirates at second respiration rate 512.
  • on-cycles 514 temporally overlap at least the threshold portions of the threshold percentage of subsequent inspiration phases 408 when patient 102 respirates at second respiration rate 512.
  • the threshold portion and the threshold percentage of the threshold condition for efficacy of the OSA therapy may be the same as or different from the threshold portion and the threshold percentage of tire threshold condition for first therapy cycling rate 503A
  • on-cycles 514 may be similar to on-cycles 504 (e.g., cycle width 506 may be the same as cycles width 518, pulses 504, 514 may contain a same continuous electrical signal or pulse trains of electrical pulses at the same stimulation rates).
  • system 100 may adjust other stimulation parameters (e.g., cycle width, duty cycle, type of electrical signal, signal amplitude) of cycles 514 or of the electrical signal instead of or in addition to second therapy cycling rate 503B.
  • System 100 may deliver the electrical signals at or near the hypoglossal nerve of patient 102 at second therapy cycling rate 503B (714), e.g., in accordance with other example techniques previously described herein. In some examples, system 100 may deliver electrical signals in accordance with the one or more other stimulation parameters that are determined based on second respiration rate 512.
  • FIG. 8 is a flow diagram illustrating another example process of delivering OSA therapy to patient 102.
  • System 100 may deliver the electrical signals (e.g., pulses 524 of the electrical signal) at or near the hypoglossal nerve of patient 102 at second therapy cycling rate 503B (714).
  • System 100 may predict, based on the first data set and the second data set, a third respiration rate (802).
  • the third respiration rate may be different from first respiration rate 406 and second respiration rate 512.
  • System 100 may determine, based on the sensor data within the first and second data sets, a trend in the change in the respiration rate and determine the third respiration rate based on the trend.
  • system 100 inputs the sensors data from the first and second data sets into machine learning model trained to identify future respiration rates of patient 102 based on prior respiration rates (e.g., first respiration rate 406, second respiration rate 512) or prior respiration data.
  • the machine learning model may be trained using a training data set including prior sensor data values and corresponding respiration rates.
  • the prior sensor data may be from patient 102 and/or one or more other patients.
  • System 100 may determine a time at which patient 102 will respirate at the third respiration rate. The determined time (i.e., the third time period) may immediately follow the second time period or may be separated by the second time period.
  • System 100 may determine, based on the third respiration rate, a third therapy cycling rate (804).
  • System 100 may determine the third therapy cycling rate in accordance with one or more other example techniques previously described herein, e.g., with respect to FIGS. 1 --7.
  • the third therapy cycling rate may be different from therapy cycling rates 503 A, 503B.
  • the third respiration rate is lower than respiration rates 406, 512
  • the third therapy cycling rate is lower than first or second therapy cycling rates, 503A, 503B.
  • the third respiration rate is greater than respiration rates 406, 512
  • the third therapy cycling rate is greater than first or second therapy cycling rates 503A, 503B.
  • System 100 may then deliver the electrical signals at or near the hypoglossal nerve(s) at the third therapy cycling rate (806).
  • system 100 determines third time period when patient 102 will respirate at the third respiration rate
  • system 100 delivers the electrical signal (e.g., pulses 52.4 of the electrical signal) at the third therapy cycling rate at the beginning of the third time period.
  • system 100 may store the third therapy cycling rate (e.g., in memory 210 of IMD 104, in memory' 304 of external programmer 130) and deliver the electrical signal at the third therapy cycling rate in response to system 100 determining that patient 102 is respirating at the third respiration rate.
  • sy stem 100 may determine, based on the third respiration rate, a third set of stimulation parameters instead of or in addition to the third therapy 7 cycling rate.
  • the third set of stimulation parameters may include, but are not limited to, a third cycle width or a third duty cycle of cycles of the electrical signal.
  • the techniques of this disclosure may be implemented in a wide variety of computing devices, medical devices, or any combination thereof. Any of the described units, modules or components may be implemented together or separately as discrete but interoperable logic devices. Depiction of different features as modules or units is intended to highlight different functional aspects and does not necessarily imply that such modules or units must be realized by separate hardware or software components. Rather, functionality associated with one or more modules or units may be performed by separate hardware or software components, or integrated within common or separate hardware or software components.
  • system 100 may not be limited to treatment or monitoring of a human patient.
  • system 100 may be implemented in non-human patients, e.g., primates, canines, equines, pigs, and felines. These other animals may undergo clinical or research therapies that my benefit from the subject matter of this disclosure.
  • Various examples are described herein, such as the following examples.
  • Example 1 a. system comprising: an implantable medical device (IMD) configured to deliver an electrical signal at or near a hypoglossal nerve of a patient to treat obstructive sleep apnea (OSA); one or more sensors; and processing circuitry in communication with the IMD and the one or more sensors, the processing circuitry being configured to: receive, via the one or more sensors, a data set corresponding to respiration of the patient during a time period; determine, based on the received data, a respiration rate of the patient over the time period; determine, based on the respiration rate, a therapy cycling rate of the electrical signal, wherein the therapy cycling rate defines a frequency for a plurality of on-cycles and a plurality of off-cycles of the electrical signal, wherein temporally adjacent on-cycles of the plurality of on-cycles are separated by an off-cycle of the plurali ty of off-cycles, and wherein the plurality of on-cycles overlaps a threshold percentage of subsequent
  • IMD implant
  • Example 2 the system of example 1, wherein the time period comprises a first time period, wherein the data set comprises a first data set, wherein the determined respiration rate comprises a first respiration rate, wherein the frequency comprises a first frequency, wherein the therapy cycling rate comprises a first therapy cycling rate, and wherein the processing circuitry is configured to: receive, via the one or more sensors, a second data set corresponding to respiration of the patient during a second time period, wherein the first time period precedes the second time period; determine, based on the received second data set, a change in the respiration rate of the patient over the second time period from the first respiration rate to the second respiration rate; adjust, based on the change in the respiration rate, the first therapy cycling rate of the hypoglossal nerve to a second therapy cycling rate, wherein the second therapy cycling rate defines a second frequency of the plurality of on-cycles and the plurality of off-cycles of the electrical signal, wherein the second frequency is different from the first frequency, and wherein at the second
  • Example 3 the system of example 2, wherein the processing circuitry is configured to: predict, based on the first data set and the second data set, a third respiration rate, the third respiration rate being different from the first respiration rate and the second respiration rate; determine, based on the third respiration rate, a third therapy cycling rate, wherein the third therapy cycling rate defines a third frequency of tire plurality of on- cycles and the plurality of off-cycles of the electrical signal, wherein the third frequency is different from the first frequency and the second frequency, and wherein at the third frequency, the plurality of on-cycles overlaps the threshold percentage of subsequent inspiration phases of respiration at the third respiration rate when the electrical signal is delivered at the third therapy cycling rate; and cause the IMD to deliver the electrical signal at or near the hypoglossal nerve at the third therapy cycling rate.
  • Example 4 the system of any of examples 2 and 3, wherein at the first therapy cycling rate, the plurality of on-cycles of the electrical signal defines a first cycle width, and wherein the processing circuitry'- is configured to: adjust, based on the change in the respiration rate, the first cycle width to a second cycle width, wherein a duration of each on-cycle of the plurality of on-cycle of the electrical signal is defined by the second cycle width, and wherein at the second frequency and the second cycle width, the plurality of on-cycles overlaps the threshold percentage of subsequent inspiration phases of respiration at the second respiration rate when the electrical signal is delivered at the second therapy cycling rate and the second cycle width.
  • Example 5 the system of any of examples 1-4, wherein to determine the therapy cycling rate, the processing circuitry is configured to: determine, based on the respiration rate and a duration of the time period, a proportion of subsequent respiration corresponding to the subsequent inspiration phases; and determine, based on the proportion of the subsequent respiration corresponding to the subsequent inspiration phases, the therapy cycling rate, wherein at the frequency of the therapy cycling rate, one or more of the plurality’ of on-cycles temporally overlaps with at least a threshold portion of the proportion of subsequent respiration.
  • Example 6 the system of any of examples 1 -5, wherein the therapy cycling rate is independent of timing of the subsequent inspiration phases.
  • Example 7 the system of any of examples 1-6, wherein the electrical signal comprises a plurality of cycles, each cycle comprising an on-cycle of the plurality of on- cycles and an off-cycle of the plurality of off-cycles, the off-cycle being temporally adjacent to the on -cycle, and wherein each cycle of the plurality’ of cycles of the electrical signal defines a duty cycle, wherein the duty cycle comprises a ratio between a duration of the on-cycle and a duration of the cycle.
  • Example 8 the system of any of examples 1-7, wherein the respiration rate comprises an average respiration rate across the time period.
  • Example 9 the system of any of examples 1-8, further comprising an implantable lead coupled to the IMD, the implantable lead comprising: an elongated body; and one or more electrodes disposed on a distal portion of the elongated body, the one or more electrodes being configured to be positioned proximate the hypoglossal nerve of the patient.
  • Example 10 the system of example 9, wherein the one or more sensors comprises at least one of the one or more electrodes.
  • Example 11 the system of any of examples 1- 10, wherein the one or more sensors comprises an accelerometer.
  • Example 12 the system of any of examples 1-1 1 , wherein the IMD includes the processing circuitry.
  • Example 13 the system of any of examples 1-12, wherein the IMD includes at least one of the one or more sensors.
  • Example 14 the system of any of examples 1-13, wherein the processing circuitry is configured to: cause the IMD to deliver the electrical signal during each on- cycle of the plurality of on-cycles; and cause the IMD to not deliver the electrical signal during each off-cycle of the plurality of off-cycles.
  • Example 15 the system of example 14, wherein the processing circuitry is configured to cause the IMD to deliver a constant electrical signal during each on-cycle.
  • Example 16 the system of example 14, wherein during each on-cycle, the processing circuitry is configured to cause the IMD to deliver a plurality of electrical pulses at a stimulation rate.
  • Example 17 the system of example 16, wherein the stimulation rate is independent of the therapy cycling rate.
  • Example 18 a method for treating obstructive sleep apnea (OSA), the method comprising: sensing, via one or more sensors of a medical system, a data set corresponding to respiration of a patient during a time period; determining, by processing circuitry' of the medical system and based on the data set, a respiration rate of the patient over the time period; determining, by the processing circuitry and based on the respiration rate, a therapy cycling rate of an electrical signal, wherein the therapy cycling rate defines a frequency of a plurality of on-cycles and a plurality of off-cycles of the electrical signal, wherein temporally adjacent on-cycles are separated by an off-cycle, and wherein at the frequency, the plurality of on-cycles overlaps a threshold percentage of subsequent inspiration phases when the electrical signal is delivered at the therapy cycling rate; and causing, by the processing circuitry', an IMD of the medical system to deliver the electrical signal at or near a hypoglossal nerve of the patient at the
  • Example 19 the method of example 18, wherein the time period comprises a first time period, wherein the data set comprises a first data set, wherein the determined respiration rate comprises a first respiration rate, wherein the frequency defines a first frequency, wherein the therapy cycling rate comprises a first therapy cycling rate, and wherein the method further comprises: sensing, via the one or more sensors, a second data set corresponding to respiration of the patient during a second time period, wherein the first time period precedes the second time period; determining, by the processing circuitry and based on the second data set, a change in the respiration rate of the patient over the second time period from the first respiration rate to the second respiration rate; adjusting, by the processing circuitry and based on the change in the respiration rate, the first therapy cycling rate to a second therapy cycling rate, wherein the second therapy cycling rate defines a second frequency of the plurality of on-cycles and the plurality of off-cycles of the electrical signal, wherein the second frequency is different from the first frequency, and wherein
  • Example 20 the method of example 19, further comprising: predicting, by the processing circuitry and based on the first data set and the second data set, a third respiration rate, the third respiration rate being different from the first respiration rate and the second respiration rate; determining, by the processing circuitry and based on the third respiration rate, a third therapy cycling rate, wherein the third therapy cycling rate defines a third frequency of the plurality of on-cycles and the plurality of off-cycles of the electrical signal, wherein the third frequency is different from the first frequency and the second frequency, and wherein at the third frequency, the plurality of on-cycles overlaps the threshold percentage of the subsequent inspiration phases of respirati on at the third respiration rate when the electrical signal is delivered at the third therapy cycling rate; and causing, by the processing circuitry, the IMD to deliver the electrical signal at or near the hypoglossal nerve at the third therapy cycling rate,
  • Example 21 the method of any of examples 19 and 20, wherein at the first therapy cycling rate, the plurality of on-cycles of the electrical signal defines a first cycle width, and wherein the method comprises: adjusting, by the processing circuitry and based on the change m the respiration rate, the first cycle width to a second cycle width, wherein a duration of each on-cycle of the plurality of on-cycles of the electrical signal is defined by the second cycle width, and wherein at the second frequency and the second cycle width, the plurality of on-cycles overlaps the threshold percentage of subsequent inspiration phases of respiration at the second respiration rate when the electrical signal is delivered at the second therapy cycling rate; and causing, by the processing circuitry, the IMD to deliver the electrical signal at or near the hypoglossal nerve at the second therapy cycling rate and the second cycle width.
  • Example 22 the method of any of examples 19-21, wherein determining the therapy cycling rate comprises: determining, by the processing circuitry and for each respiration cycle of the patient, a proportion of subsequent respiration corresponding to the subsequent inspiration phases; and determining, by the processing circuitry and based on the proportion of the subsequent respiration corresponding to the subsequent inspiration phases, the therapy cycling rate, wherein at the frequency of die therapy cycling rate, one or more of the plurality of on-cycles temporally overlaps with at least a threshold portion of the proportion of subsequent respiration.
  • Example 23 the method of any of examples 19-22, wherein the therapy cycling rate is independent of timing of the subsequent inspiration phases.
  • Example 24 the method of any of examples 19—23, wherein the electrical signal comprises a plurality of cycles, each cycle comprising an on-cycle of the plurality of on-cycles and an off-cycle of the plurality of off-cycles, the off-cycle being temporally adjacent to the on -cycle, and wherein each cycle of the plurality of cycles of the electrical signal defines a duty cycle, wherein the duty cycle comprises a ratio between a duration of the on-cycle and a duration of the cycle.
  • Example 25 the method of any of examples 19-24, wherein the respiration rate comprises an average respiration rate across the time period.
  • Example 26 the method of any of examples 19-25, wherein causing the IMD to deliver the electrical signal at or near the hypoglossal nerve of the patient at the therapy cycling rate comprises: causing, by the processing circuitry, the IMD to deliver the electrical signal during each on-cycle of the plurality of on-cycles; and causing, by the processing circuitry, the IMD to not deliver the electrical signal during each off-cycle of the plurality of off-cycles.
  • Example 27 the method of example 26, wherein causing the IMD to deliver the electrical signal during each on-cycle comprises causing, by the processing circuitry, the IMD to deliver a constant electrical signal during each on-cycle.
  • Example 28 the method of example 26, wherein causing the IMD to deliver the electrical signal during each on-cycle comprises causing, by the processing circuitry, the IMD to deliver a plurality of electrical pulses at a stimulation rate during each on- cycle.
  • Example 29 the method of example 28, wherein the stimulation rate is independent of the therapy cycling rate.
  • Example 30 the method of any of examples 19-29, wherein the IMD comprises: a housing; and signal generation circuitry disposed within the housing, the signal generation circuitry being configured to generate tire electrical signal; and wherein the medical system comprises an implantable lead coupled to the IMD, the implantable lead comprising: an elongated body; and one or more electrodes disposed at a distal portion of the elongated body and configured to be positioned proximate the hypoglossal nerve of the patient, and wherein causing the IMD to deliver the electrical signal at or near the hypoglossal nerve at the therapy cycling rate comprises: causing, by the processing circuitry, the signal generation circuitry of the IMD to deliver the electrical signal to the hypoglossal nerve via the one or more electrodes on tire implantable lead.
  • Example 31 the method of example 30, wherein the one or more sensors comprises at least one of the one or more electrodes.
  • Example 32 the method of any of examples 19 -31, wherein the one or more sensors comprises an accelerometer.
  • Example 33 the method of any of examples 19-32, wherein the processing circuitry is disposed within the IMD.
  • Example 34 the method of any of examples 19-33, wherein at least one of the one or more sensors is disposed within the IMD.
  • Example 35 a computer-readable medium comprising instructions that, when executed, causes processing circuitry of a medical system to perform the method of any of examples 19-34.

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Abstract

L'invention concerne un système comprenant : un dispositif médical implantable (IMD) conçu pour délivrer un signal électrique au niveau ou à proximité d'un nerf hypoglosse d'un patient pour traiter l'apnée obstructive du sommeil (OSA) ; un ou plusieurs capteurs ; et des circuits de traitement conçus pour : recevoir, par l'intermédiaire du ou des capteurs, un ensemble de données correspondant à la respiration du patient pendant une période de temps ; déterminer, sur la base des données reçues, un rythme respiratoire du patient sur la période de temps ; déterminer, sur la base du rythme respiratoire, un rythme de cyclage de thérapie du signal électrique, le rythme de cyclage de thérapie définissant une fréquence d'une pluralité d'impulsions du signal électrique, la pluralité d'impulsions chevauchant un pourcentage seuil de phases d'inspiration subséquentes lorsque le signal électrique est délivré à la fréquence ; et amener l'IMD à délivrer le signal électrique au niveau ou à proximité du nerf hypoglosse au rythme de cyclage de thérapie.
PCT/US2024/022326 2023-05-09 2024-03-29 Thérapie d'apnée obstructive du sommeil basée sur le rythme respiratoire Pending WO2024233013A1 (fr)

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