Method and System for Automated Neuromodulation through Machine Learning

Abstract

An automated neuromodulation system which uses patient feedback during a training phase in combination with machine learning to automatically provide optimal nerve stimulation parameters based on the patient's needs without patient input. The automated neuromodulation system generally includes a lead which is implanted in a patient for treatment of a wide range of conditions, such as chronic pain. The patient is provided with a remote control through which the patient may provide either positive or negative feedback relating to how the patient is responding to electrical stimulation in different situations. A control unit monitors feedback from the patient as well as information and data from the time of feedback, such as the patient's position, orientation, speed of movement, or other considerations. Using machine learning, the control unit may process the feedback and data to formulate an optimized neuromodulation protocol and criteria which may be automatically applied to the patient.

1 - 22 . (canceled) 
     
     
         23 . An automated neuromodulation system, comprising:
 a plurality of leads, each of the plurality of leads being implanted within one of a plurality of patients, wherein each of the plurality of leads is connected to an afflicted area of one of the plurality of patients;   a plurality of pulse generators, each of the plurality of pulse generators being in communication with one of the plurality of leads, wherein each of the plurality of leads is adapted to apply an electrical stimulation to the afflicted area of one of the plurality of patients;   a plurality of control units, each of the plurality of control units being communicatively connected to one of the plurality of pulse generators;   a plurality of sensors, each of the plurality of sensors being communicatively connected to one of the plurality of control units, wherein each of the plurality of sensors is adapted to detect a condition of one of the plurality of patients;   a plurality of remote controls, each of the plurality of remote controls being communicatively connected to one of the plurality of control units and one of the plurality of pulse generators, wherein each of the plurality of remote controls comprises an input for providing patient feedback to the electrical stimulation; and   a remote server including a central database, wherein each of the plurality of control units is communicatively connected to the remote server;   wherein each of the plurality of control units is adapted to transmit the patient feedback and the condition of one of the plurality of patients at a time of the patient feedback to the remote server;   wherein the remote server is adapted to process the patient feedback and the condition of the plurality of patients at a time of the patient feedback to formulate a baseline electrical stimulation protocol to be applied to a new patient, wherein the baseline electrical stimulation protocol comprises criteria for application of the electrical stimulation based on the condition of the new patient.   
     
     
         24 . The automated neuromodulation system of  claim 23 , wherein the baseline electrical stimulation protocol is adapted to be continuously updated by the remote server. 
     
     
         25 . The automated neuromodulation system of  claim 23 , wherein the baseline electrical stimulation protocol is stored in the central database. 
     
     
         26 . A method of developing an automated neuromodulation protocol for a patient using the automated neuromodulation system of  claim 23 , comprising the steps of:
 collating the baseline electrical stimulation protocol in the central database by the remote server; and   utilizing machine learning to determine an effective electrical stimulation program for one of the plurality of patients based on patient feedback by the remote server.   
     
     
         27 . The automated neuromodulation system of  claim 23 , further comprising a smart phone communicatively connected to at least one of the plurality of pulse generators, wherein the at least one of the plurality of pulse generators is adapted to access health information from the smart phone to provide data back to one of the plurality of control units. 
     
     
         28 . The automated neuromodulation system of  claim 27 , wherein the health information from the smart phone is comprised of a pedometer reading, screen time, sleep time, heart rate, blood pressure, blood sugar, and activity level. 
     
     
         29 . The automated neuromodulation system of  claim 23 , wherein the input of each of the plurality of remote controls is adapted to provide positive patient feedback. 
     
     
         30 . The automated neuromodulation system of  claim 23 , wherein each of the plurality of sensors is implanted in one of the plurality of patients. 
     
     
         31 . The automated neuromodulation system of  claim 23 , wherein the plurality of remote controls are each comprised of a necklace. 
     
     
         32 . The automated neuromodulation system of  claim 23 , wherein the plurality of remote controls are each comprised of a key fob. 
     
     
         33 . The automated neuromodulation system of  claim 23 , wherein the afflicted area is comprised of a nerve. 
     
     
         34 . The automated neuromodulation system of  claim 23 , wherein each of the plurality of leads is connected to a neural tissue. 
     
     
         35 . A method of developing an automated neuromodulation protocol for a new patient using the automated neuromodulation system of  claim 23 , comprising the steps of:
 implanting each of the plurality of leads within each of the plurality of patients;   applying the electrical stimulation to the afflicted area of each of the plurality of patients by each of the plurality of pulse generators;   selecting the input of each of the plurality of remote controls by each of the plurality of patients to provide the patient feedback;   receiving the patient feedback from the plurality of remote controls by the remote server;   receiving the condition of the plurality of patients from the plurality of sensors by the remote server; and   processing the patient feedback and the condition of the plurality of patients by the remote server to develop an automated neuromodulation protocol for the new patient.   
     
     
         36 . The method of  claim 35 , further comprising the step of:
 conducting a training phase with each of the plurality of patients during which different levels of the electrical stimulation are applied to each of the plurality of patients by each of the plurality of pulse generators via each of the plurality of leads while each of the plurality of patients performs an activity.   
     
     
         37 . The method of  claim 36 , wherein the activity is selected from a group consisting of walking around a room, standing up from a sitting position, flexion and extension of a spine, or flexion and extension of a limb or joint. 
     
     
         38 . An automated neuromodulation system, comprising:
 a plurality of leads, each of the plurality of leads being implanted within one of a plurality of patients for treatment of an ailment, wherein each of the plurality of leads is connected to an afflicted area of one of the plurality of patients;   a plurality of pulse generators, each of the plurality of pulse generators being in communication with one of the plurality of leads, wherein each of the plurality of leads is adapted to apply an electrical stimulation to the afflicted area of one of the plurality of patients;   a plurality of control units, each of the plurality of control units being communicatively connected to one of the plurality of pulse generators;   a plurality of remote controls, each of the plurality of remote controls being communicatively connected to one of the plurality of control units and one of the plurality of pulse generators, wherein each of the plurality of remote controls comprises a first input for providing positive patient feedback to the electrical stimulation and a second input for providing negative patient feedback to the electrical stimulation; and   a remote server including a central database, wherein each of the plurality of control units is communicatively connected to the remote server;   wherein each of the plurality of control units is adapted to transmit the positive patient feedback and the negative patient feedback of one of the plurality of patients to the remote server;   wherein the remote server is adapted to process the positive patient feedback and the negative patient feedback of the plurality of patients to formulate a baseline electrical stimulation protocol for a new patient, wherein the baseline electrical stimulation protocol comprises criteria for application of the electrical stimulation for the new patient.   
     
     
         39 . The automated neuromodulation system of  claim 38 , wherein each of the plurality of pulse generators is in wireless communication with at least one of the plurality of leads. 
     
     
         40 . The automated neuromodulation system of  claim 38 , wherein each of the plurality of leads is connected to a spinal cord of one of the plurality of patients. 
     
     
         41 . The automated neuromodulation system of  claim 38 , wherein the afflicted area is comprised of a nerve. 
     
     
         42 . The automated neuromodulation system of  claim 38 , wherein the ailment is comprised of nerve pain. 
     
     
         43 . The automated neuromodulation system of  claim 38 , wherein the plurality of remote controls are each comprised of a smart phone. 
     
     
         44 . A method of developing an automated neuromodulation protocol for a new patient using the automated neuromodulation system of  claim 38 , comprising the steps of:
 implanting each of the plurality of leads at the afflicted area within each of the plurality of patients;   applying the electrical stimulation to the afflicted area of each of the plurality of patients by each of the plurality of pulse generators;   selecting the first input of each of the plurality of remote controls by each of the plurality of patients to provide the positive patient feedback;   selecting the second input of each of the plurality of remote controls by each of the plurality of patients to provide the negative patient feedback;   receiving the positive patient feedback and the negative patient feedback from the plurality of remote controls by the remote server; and   processing the positive patient feedback and the negative patient feedback by the remote server to develop an automated neuromodulation protocol for the new patient.   
     
     
         45 . The automated neuromodulation system of  claim 38 , further comprising a plurality of sensors, each of the plurality of sensors being communicatively connected to one of the plurality of control units, wherein each of the plurality of sensors is adapted to detect a condition of one of the plurality of patients. 
     
     
         46 . The automated neuromodulation system of  claim 45 , wherein each of the plurality of sensors is directly connected to one of the plurality of pulse generators. 
     
     
         47 . The automated neuromodulation system of  claim 45 , wherein the condition is comprised of a position and orientation of one of the plurality of patients. 
     
     
         48 . A method of developing an automated neuromodulation protocol for a new patient using the automated neuromodulation system of  claim 45 , comprising the steps of:
 implanting each of the plurality of leads at the afflicted area within each of the plurality of patients;   applying the electrical stimulation to the afflicted area of each of the plurality of patients by each of the plurality of pulse generators;   selecting the first input of each of the plurality of remote controls by each of the plurality of patients to provide the positive patient feedback;   selecting the second input of each of the plurality of remote controls by each of the plurality of patients to provide the negative patient feedback;   receiving the positive patient feedback and the negative patient feedback from the plurality of remote controls by the remote server;   receiving the condition of the plurality of patients from the plurality of sensors by the remote server; and   processing the positive patient feedback, the negative patient feedback, and the condition of the plurality of patients by the remote server to develop an automated neuromodulation protocol for the new patient.   
     
     
         49 . An automated neuromodulation system, comprising:
 a plurality of leads, each of the plurality of leads being implanted within one of a plurality of patients for treatment of an ailment, wherein each of the plurality of leads is connected to an afflicted area of one of the plurality of patients;   a plurality of pulse generators, each of the plurality of pulse generators being in communication with one of the plurality of leads, wherein each of the plurality of leads is adapted to apply an electrical stimulation to the afflicted area of one of the plurality of patients;   a plurality of control units, each of the plurality of control units being communicatively connected to one of the plurality of pulse generators;   a plurality of remote controls, each of the plurality of remote controls being communicatively connected to one of the plurality of control units and one of the plurality of pulse generators, wherein each of the plurality of remote controls comprises a first input for providing positive patient feedback to the electrical stimulation and a second input for providing negative patient feedback to the electrical stimulation;   a plurality of sensors, wherein each of the plurality of sensors is implanted in one of the plurality of patients, each of the plurality of sensors being communicatively connected to one of the plurality of control units, wherein each of the plurality of sensors is adapted to detect a condition of one of the plurality of patients;   a plurality of smart phones, wherein each of the plurality of smart phones is communicatively connected to one of the plurality of pulse generators, wherein each of the plurality of pulse generators is adapted to access health information from one of the plurality of smart phones to provide data back to one of the plurality of control units, wherein the health information from each of the plurality of smart phones is comprised of a pedometer reading, a screen time, a sleep time, a heart rate, a blood pressure, a blood sugar, and an activity level; and   a remote server including a central database, wherein each of the plurality of control units is communicatively connected to the remote server;   wherein each of the plurality of control units is adapted to transmit the positive patient feedback and the negative patient feedback of one of the plurality of patients to the remote server;   wherein the remote server is adapted to process the positive patient feedback and the negative patient feedback of the plurality of patients to formulate a baseline electrical stimulation protocol for a new patient, wherein the baseline electrical stimulation protocol comprises criteria for application of the electrical stimulation for the new patient.   
     
     
         50 . A method of developing an automated neuromodulation protocol for a new patient using the automated neuromodulation system of  claim 49 , comprising the steps of:
 implanting each of the plurality of leads at the afflicted area within each of the plurality of patients;   applying the electrical stimulation to the afflicted area of each of the plurality of patients by each of the plurality of pulse generators;   selecting the first input of each of the plurality of remote controls by each of the plurality of patients to provide the positive patient feedback;   selecting the second input of each of the plurality of remote controls by each of the plurality of patients to provide the negative patient feedback;   receiving the positive patient feedback and the negative patient feedback from the plurality of remote controls by the remote server;   receiving the condition of the plurality of patients from the plurality of sensors by the remote server; and   processing the positive patient feedback, the negative patient feedback, and the condition of the plurality of patients by the remote server to develop an automated neuromodulation protocol for the new patient.