Meal detection devices and methods

Abstract

Devices and methods for detecting meal intake are disclosed herein. In some embodiments, one or more sensors can be used to detect or monitor physiological parameters of a user (e.g., heart rate, body movements, temperature, pH, impedance, gastric stretch, sound emissions, and the like). The outputs of the sensors can be received by a computer system configured to analyze the sensor data and make a determination as to whether meal intake has occurred or is presently occurring. The computer system's determination can be used to trigger, modulate, or otherwise control one or more therapeutic devices. Other types of devices can also be controlled using this determination, such as monitoring or logging devices.

1 . A medical system, comprising:
 a sensor configured to gather data regarding a physiological parameter of a user;   a device configured to deliver a therapy to the user; and   a computer system configured to
 receive gathered data from the sensor, 
 compare the received data to a predetermined threshold value, and 
 based on the comparison, trigger the device to deliver the therapy to the user; 
   wherein the therapy includes at least one of electrically stimulating tissue of the user, delivering a therapeutic agent to the user, delivering insulin to the user, modulating bile acid levels in the user, modulating gastric pH levels in the user, inducing an aversive response in the user, stimulating release of GLP-1 in the user, activating brown adipose tissue in the user, controlling tonal contractions of a stomach of the user, and modulating gastric emptying in the user.   
     
     
         2 . The system of  claim 1 , wherein the physiological parameter includes at least one of heart rate of the user, motion of the user, temperature of the user, pH at one or more points along a gastrointestinal tract of the user, impedance of tissue of the user, electrical activity of tissue of the user, gastric stretch of the user, and sound emission by the user. 
     
     
         3 . The system of  claim 2 , wherein the physiological parameter includes at least the impedance of tissue of the user; and
 the sensor includes an impedance sensor configured to monitor the impedance.   
     
     
         4 . The system of  claim 3 , wherein the gathered data includes a plurality of values gathered over a period of time;
 the computer system is configured to calculate an energy-based index using the plurality of values;   comparing the received data to the predetermined threshold value includes comparing the energy-based index to the predetermined threshold value; and   the computer system is configured to trigger the device to deliver the therapy in response to the energy-based index being greater than or equal to the predetermined threshold value.   
     
     
         5 . The system of  claim 2 , wherein the physiological parameter includes at least the motion of the user; and
 the sensor includes an accelerometer configured to monitor the motion.   
     
     
         6 . The system of  claim 5 , wherein the gathered data includes a plurality of values gathered over a period of time;
 the computer system is configured to calculate an energy-based index using the plurality of values;   comparing the received data to the predetermined threshold value includes comparing the energy-based index to the predetermined threshold value; and   the computer system is configured to trigger the device to deliver the therapy in response to the energy-based index being greater than or equal to the predetermined threshold value.   
     
     
         7 . The system of  claim 2 , wherein the system comprises at least one of:
 the physiological parameter including the heart rate of the user, and the sensor including a heart rate sensor,   the physiological parameter including the temperature of the user, and the sensor including a temperature sensor,   the physiological parameter including the pH at one or more points along the gastrointestinal tract of the user, and the sensor including a pH sensor,   the physiological parameter including the electrical activity of tissue of the user, and the sensor including an electrogastrograph,   the physiological parameter including the gastric stretch of the user, and the sensor including a gastric stretch sensor, and   the physiological parameter including the sound emission by the user, and the sensor including a microphone.   
     
     
         8 . The system of  claim 1 , wherein the sensor, the device, and the computer system are each configured to be implanted in the user. 
     
     
         9 . The system of  claim 1 , wherein at least one of the sensor, the device, and the computer system is configured to be implanted in the user; and
 a remainder of the sensor, the device, and the computer system is configured to be positioned externally of the user when the device is delivering the therapy.   
     
     
         10 . The system of  claim 1 , wherein the sensor, the device, and the computer system are each configured to be positioned externally of the user when the device is delivering the therapy. 
     
     
         11 . The system of  claim 1 , wherein the gathered data includes a plurality of values gathered over a period of time;
 the computer system is configured to calculate an index using the plurality of values;   comparing the received data to the predetermined threshold value includes comparing the index to the predetermined threshold value;   the computer system is configured to trigger the device to deliver the therapy in response to the index being greater than or equal to the predetermined threshold value.   
     
     
         12 . The system of  claim 11 , wherein the index being greater than or equal to the predetermined threshold value is indicative of meal intake by the user. 
     
     
         13 . The system of  claim 1 , wherein the device includes a plurality of electrodes, and the therapy includes at least one of electrically stimulating tissue of the user using the electrodes, inducing an aversive response in the user using the electrodes, stimulating release of GLP-1 in the user, controlling tonal contractions of a stomach of the user, modulating gastric emptying in the user, and activating brown adipose tissue in the user using the electrodes. 
     
     
         14 . The system of  claim 1 , wherein the device includes a delivery device, and the therapy includes at least one of the delivery device delivering the therapeutic agent to the user, modulating bile acid levels in the user, modulating bile acid levels in the user, inducing an aversive response in the user, stimulating release of GLP-1 in the user, and the delivery device delivering the insulin to the user. 
     
     
         15 . The system of  claim 1 , wherein the device includes one of a gastric band configured to be implanted in the patient, and a gastric space occupying device configured to be implanted in the user;
 when the device includes the gastric band, the therapy includes adjusting the gastric band in the patient; and   when the device includes the gastric space occupying device, the therapy includes adjusting a size or volume of the gastric space occupying device in the patient.   
     
     
         16 . A medical method, comprising:
 measuring impedance across one or more portions of a user using an impedance sensor;   sensing movement of one or more portions of a user using an accelerometer;   using a processor in communication with the impedance sensor and the accelerometer, analyzing outputs of the impedance sensor and the accelerometer to detect meal intake by the user; and   automatically triggering a controlled device to deliver a therapy to the user in response to meal intake detected by the processor;   wherein sensing movement of one or more portions of the user comprises at least one of sensing movement of at least one of the user's arms and sensing movement of the user's jaw; and   wherein measuring impedance across one or more portions of the user comprises at least one of measuring a neck impedance of the user and measuring a gastric impedance of the user.   
     
     
         17 . The method of  claim 16 , further comprising using the processor to calculate an impedance sensor index and an impedance sensor threshold value;
 wherein detecting the meal intake includes determining that the impedance sensor index exceeds the impedance sensor threshold value.   
     
     
         18 . The method of  claim 17 , wherein the calculation of the impedance sensor index is based on the median energy of the impedance sensor output in a frequency band of interest. 
     
     
         19 . The method of  claim 17 , wherein the impedance sensor index not exceeding the impedance sensor threshold value is indicative of no meal intake. 
     
     
         20 . The method of  claim 19 , further comprising using the processor to calculate an accelerometer index and an accelerometer threshold value;
 the accelerometer index not exceeding the accelerometer threshold value is indicative of no meal intake.   
     
     
         21 . The method of  claim 17 , wherein the calculation of the accelerometer index is based on the total energy of the accelerometer output in a frequency band of interest.