Obstructive sleep apnea patient programmer for implantable devices

Abstract

An implantable neurostimulator system including an electrical lead having formed thereon a pair of bipolar electrodes, the electrical lead is configured for placement of the pair of bipolar electrodes proximate protrusor muscles of a patient. The system also includes a pulse generator electrically connected to the electrical lead and configured to deliver electrical energy to the pair of bipolar electrodes, the pulse generator having mounted therein a sensor configured to detect one or more physiological parameters, a memory, a control circuit, and a telemetry circuit. The system also including a communications telemetry module (CTM) in communication with the telemetry circuit and configured to receive a data collected by the sensor and data related to delivery of electrical energy to the bipolar electrodes, and an external programmer in communication with the CTM and configured to display a user interface the data collected by the sensor and data related to delivery of electrical energy to the bipolar electrodes.

1 - 20 . (canceled) 
     
     
         21 . An implantable neurostimulator (INS) system comprising:
 an electrical lead comprising one or more stimulation electrodes for delivery of electrical energy and one or more sensing electrodes configured to sense an electromyograph (EMG), wherein the electrical lead is configured for percutaneous implantation and placement of the one or more stimulation electrodes for delivery of the electrical energy proximate, and without attaching, to one or more nerves of at least one of a genioglossus muscle or a geniohyoid muscle, which form protrusor muscles within a tongue, and proximate to one or more motor points of the protrusor muscles of a patient, and the one or more sensing electrodes are configured to sense the EMG proximate the protrusor muscles within the tongue; and   a sensor configured to detect one or more physiological parameters; and   processing circuitry configured to:
 determine a tonal state of at least one of the genioglossus muscle or the geniohyoid muscle that form the protrusor muscles within the tongue of the patient based on the sensed EMG; 
 determine an instance where (1) the tonal state of at least one of the genioglossus muscle or the geniohyoid muscle is a low tonal state, based on the sensed EMG, and (2) an apnea is likely to occur, based on the one or more physiological parameters; and 
 control a timing of when electrical energy is delivered to the one or more stimulation electrodes for delivery of the electrical energy based on the determined instance. 
   
     
     
         22 . The system of  claim 21 , further comprising a pulse generator, wherein the pulse generator comprises the processing circuitry. 
     
     
         23 . The system of  claim 21 , wherein the processing circuitry is configured to execute an artificial intelligence (AI) engine, and wherein the AI engine is configured to:
 determine the tonal state of at least one of the genioglossus muscle or the geniohyoid muscle that form the protrusor muscles within the tongue of the patient based on the sensed EMG,   determine the instance where (1) the tonal state of at least one of the genioglossus muscle or the geniohyoid muscle is the low tonal state, based on the sensed EMG, and (2) the apnea is likely to occur, based on the data collected by the sensor, and   control the timing of when the electrical energy is delivered to the one or more stimulation electrodes for delivery of the electrical energy based on the determined instance.   
     
     
         24 . The system of  claim 21 , further comprising:
 a communications telemetry module (CTM) configured to receive data collected by the sensor and data related to the delivery of electrical energy; and   an external programmer in communication with the CTM and configured to display a user interface that includes one or more of the data collected by the sensor and the data related to the delivery of the electrical energy.   
     
     
         25 . The system of  claim 21 , wherein the processing circuitry is configured to adjust parameters of the electrical energy based on the tonal state of at least one of the genioglossus muscle or the geniohyoid muscle. 
     
     
         26 . The system of  claim 21 , wherein the one or more physiological parameters include one or more of motion data, heart rate data, electrocardiogram data, respiration rate data, blood-oxygen saturation data or posture data. 
     
     
         27 . The system of  claim 21 , wherein the processing circuitry is configured to calculate one or more of an Apnea-Hypopnea Index (AHI) value, a Respiration Disturbance Index (RDI) value, total sleep time, sleep efficiency value, or therapeutic efficiency based on the one or more physiological parameters. 
     
     
         28 . The system of  claim 21 , wherein the processing circuitry is configured to:
 analyze electronic medical record (EMR) data of a population;   identify one or more parameters for adjustment in a therapy delivery program for the delivery of the electrical energy based on the analysis of the EMR data; and   adjust the one or more parameters of the therapy delivery program.   
     
     
         29 . The system of  claim 21 , wherein at least one of the one or more stimulation electrodes and at least one of the one or more sensing electrodes is the same electrode. 
     
     
         30 . A method comprising:
 receiving information of an electromyograph (EMG) sensed proximate to protrusor muscles within a tongue of a patient with one or more sensing electrodes of an electrical lead configured to sense the EMG, wherein the electrical lead comprises one or more stimulation electrodes for delivery of electrical energy and the one or more sensing electrodes, and wherein the electrical lead is configured for percutaneous implantation and placement of the one or more stimulation electrodes proximate, and without attaching, to one or more nerves of at least one of a genioglossus muscle or a geniohyoid muscle, which form the protrusor muscles within the tongue, and proximate to one or more motor points of the protrusor muscles of the patient;   receiving information of one or more physiological parameters;   determining a tonal state of at least one of the genioglossus muscle or the geniohyoid muscle that form the protrusor muscles within the tongue of the patient based on the sensed EMG;   determining an instance where (1) the tonal state of at least one of the genioglossus muscle or the geniohyoid muscle is a low tonal state, based on the sensed EMG, and (2) an apnea is likely to occur, based on the one or more physiological parameters; and   controlling a timing of when electrical energy is delivered to the one or more stimulation electrodes for delivery of the electrical energy based on the determined instance.   
     
     
         31 . The system of  claim 30 , further comprising executing an artificial intelligence (AI) engine, and wherein executing the AI engine causes:
 determining the tonal state of at least one of the genioglossus muscle or the geniohyoid muscle that form the protrusor muscles within the tongue of the patient based on the sensed EMG;   determining the instance where (1) the tonal state of at least one of the genioglossus muscle or the geniohyoid muscle is the low tonal state, based on the sensed EMG, and (2) the apnea is likely to occur, based on the data collected by the sensor; and   controlling the timing of when the electrical energy is delivered to the one or more stimulation electrodes for delivery of the electrical energy based on the determined instance.   
     
     
         32 . The method of  claim 30 , further comprising adjusting parameters of the electrical energy based on the tonal state of at least one of the genioglossus muscle or the geniohyoid muscle. 
     
     
         33 . The method of  claim 30 , wherein the one or more physiological parameters include one or more of motion data, heart rate data, electrocardiogram data, respiration rate data, blood-oxygen saturation data or posture data. 
     
     
         34 . The method of  claim 30 , further comprising calculating one or more of an Apnea-Hypopnea Index (AHI) value, a Respiration Disturbance Index (RDI) value, total sleep time, sleep efficiency value, or therapeutic efficiency based on the one or more physiological parameters. 
     
     
         35 . The method of  claim 30 , further comprising:
 analyzing electronic medical record (EMR) data of a population;   identifying one or more parameters for adjustment in a therapy delivery program for the delivery of the electrical energy based on the analysis of the EMR data; and   adjusting the one or more parameters of the therapy delivery program.   
     
     
         36 . The method of  claim 30 , wherein at least one of the one or more stimulation electrodes and at least one of the one or more sensing electrodes is the same electrode. 
     
     
         37 . A computer-readable storage medium storing instructions thereon that when executed cause one or more processors to:
 receive information of an electromyograph (EMG) sensed proximate to protrusor muscles within a tongue of a patient with one or more sensing electrodes of an electrical lead configured to sense the EMG, wherein the electrical lead comprises one or more stimulation electrodes for delivery of electrical energy and the one or more sensing electrodes, and wherein the electrical lead is configured for percutaneous implantation and placement of the one or more stimulation electrodes proximate, and without attaching, to one or more nerves of at least one of a genioglossus muscle or a geniohyoid muscle, which form the protrusor muscles within the tongue, and proximate to one or more motor points of the protrusor muscles of the patient;   receive information of one or more physiological parameters;   determine a tonal state of at least one of the genioglossus muscle or the geniohyoid muscle that form the protrusor muscles within the tongue of the patient based on the sensed EMG;   determine an instance where (1) the tonal state of at least one of the genioglossus muscle or the geniohyoid muscle is a low tonal state, based on the sensed EMG, and (2) an apnea is likely to occur, based on the one or more physiological parameters; and   control a timing of when electrical energy is delivered to the one or more stimulation electrodes for delivery of the electrical energy based on the determined instance.   
     
     
         38 . The computer-readable storage medium of  claim 37 , further comprising instructions that cause the one or more processors to adjust parameters of the electrical energy based on the tonal state of at least one of the genioglossus muscle or the geniohyoid muscle. 
     
     
         39 . The computer-readable storage medium of  claim 37 , wherein the one or more physiological parameters include one or more of motion data, heart rate data, electrocardiogram data, respiration rate data, blood-oxygen saturation data or posture data. 
     
     
         40 . The computer-readable storage medium of  claim 37 , further comprising instructions that cause the one or more processors to calculate one or more of an Apnea-Hypopnea Index (AHI) value, a Respiration Disturbance Index (RDI) value, total sleep time, sleep efficiency value, or therapeutic efficiency based on the one or more physiological parameters.