Apparatus and methods for corrective guidance of eating behavior after weight loss surgery

Abstract

Apparatuses and methods for corrective guidance of eating behavior of a patient equipped with a gastric restriction device. The apparatus provides continuous monitoring or one or more parameters related to food passing through the gastric restriction device. Each monitored parameter is processed to provide a visual indication of the current eating behavior. The visual indication is used as input to the patient or a caregiver to modify the eating behavior. In some embodiments, the apparatus includes an emergency relief mechanism that automatically relieves excess pressure developing in the gastric restriction device. In some embodiments, the apparatus is enabled to deliver an appetite suppressant to modify the eating behavior.

1 . An apparatus for modifying the eating behavior of patient equipped with a gastric restriction apparatus (GRA) comprising:
 a) monitoring means for monitoring a parameter related to food currently passing through the GRA;   b) an intra-corporal emergency relief mechanism;   c) at least one external sensor in communication with a patient's hand; and,   d) processing means adapted for (a) determining motion of said patient's hand by means of said external sensor; (b) monitoring a parameter related to food currently passing through said GRA; (c) increasing the signal received from said external sensor by filtering the influence of esophagus and lower esophagus sphincter (LES) so as to gather food passage events; and, (d) processing said parameter and said motion of said patient's hand, thereby providing an indication of a current eating pattern;   wherein said determining motion of said patients' hand and said providing an indication of a current eating pattern provides differentiation between at least two eating behavior patterns selected from a group consisting of: eating, vomiting, swallowing saliva, drinking directly from a glass, drinking via a straw, and eating liquid food with a spoon and any combination thereof.   
     
     
         2 . The apparatus of  claim 1 , wherein said an intra-corporal emergency relief mechanism is adapted for automatically relieve of pressure development. 
     
     
         3 . The apparatus of  claim 1 , wherein said pressure is developed by food currently passing through the GRA. 
     
     
         4 . The apparatus of  claim 1 , wherein said at least one external device adapted to initiating the time collection component for improved eating behavior analysis and monitoring. 
     
     
         5 . The apparatus of  claim 1 , wherein said processing means are adapted to filter at least one selected from a group consisting of (a) the influence of the esophagus & LES; and (b) the influence of patient posture while eating on food passage through the GRA; (c) other noise to collect food passage events; or any combination thereof. 
     
     
         6 . The apparatus of  claim 1 , wherein eating behavior pattern descriptive report is provided based on the analysis of at least one parameter selected from a group consisting of constant speed eater, fast or accelerated speed eater, night eater, binge eater, total size of meal, average volume of meal, and average time of meal, volumetric consumption by time, shifting to liquid food consumption, vomiting events, type of food consumed, meal times during the day and duration, average calorie of meal, segmented calorie to total calorie from Hydrocarbons, fat and Protein, new adjustment validation data and short/long term change of pressure events as a result of new adjustment or any combination thereof. 
     
     
         7 . The apparatus of  claim 1 , wherein said parameter is pressure; further wherein the processing of said parameter is performed by indication selected from the group consisting of volumetric flow, continuous volumetric flow, intermittent volumetric flow, mass flow and reynolds number or any combination thereof. 
     
     
         8 . The apparatus of  claim 1 , additionally comprising means adapted to indicate said current eating behavior through a display to the patient. 
     
     
         9 . The apparatus of  claim 1 , wherein said GRA is calibrated to a desired restriction based on the monitored parameter. 
     
     
         10 . The apparatus of  claim 1 , additionally comprising means adapted to indicate said eating behavior pattern to at least one selected from a group consisting of (a) said patient; (b) a predetermined physician; or any combination thereof. 
     
     
         11 . The apparatus of  claim 10 , wherein said indication is performed by at least one selected from a group consisting of (a) the patient; (b) said physician through appropriate instructions to said patient; (c) control signal for delivery of substance such as PYY 36 or other substance; and any combination thereof. 
     
     
         12 . The apparatus of  claim 1 , wherein said external device is selected from a group consisting of a vertical position sensor, thermometer, thermal sensor, force transducer, or a strain gauge, weighing, oscillating sensor for mass detection or any combination thereof. 
     
     
         13 . The apparatus of  claim 1 , implanted to a patient having any other bariatric procedure hence forming an apparatus for modifying eating behavior of a patient. 
     
     
         14 . The apparatus of  claim 1 , additionally comprising at least one second-type external sensor; further wherein said at least one second-type external sensor is selected from a group consisting of a vertical position sensor, thermometer, thermal sensor, force transducer, or a strain gauge, weighing, oscillating sensor for mass detection or any combination thereof. 
     
     
         15 . The apparatus of  claim 1 , wherein said increasing the signal received from said external sensor is obtained by means adapted to filter the influence of patient posture while eating on food passage through the GRA. 
     
     
         16 . The apparatus of  claim 1 , wherein said parameter related to food is pressure; further wherein said step of processing said parameter related to food is performed by determining at least one selected from a group consisting of volumetric flow, mass flow and Reynolds number. 
     
     
         17 . The apparatus of  claim 1 , additionally comprising calibrating means adapted to calibrate the GRA to a desired restriction based on the monitored parameter. 
     
     
         18 . The apparatus of  claim 1 , wherein said parameter is selected from a group consisting of total size of meal, average volume of meal, average time of meal, volumetric consumption by time, shifting to liquid food consumption, vomiting events, type of food consumed, times of meals during the day, duration of meals, new adjustment validation data, short term change of pressure events as a result of new adjustment, long term change of pressure events as a result of new adjustment, average calorie of meal, segmented calorie to total calorie from Hydrocarbons, fat and protein, and any combination thereof. 
     
     
         19 . The apparatus of  claim 1 , wherein said external sensor is embodied in at least one element selected from a group consisting of a bracelet, hand watch belt, ring, elastic band wrapped around the arm, patch with one adhesive side, an add-on to a utensil, as an integral part of a utensil, and any combination thereof. 
     
     
         20 . A device of modifying eating behavior of a patient equipped with a gastric restriction apparatus (GRA), comprising:
 a) means for monitoring a parameter related to food currently passing through the GRA by means of at least one first-type external sensor;   b) means for increasing signal received from said at least one sensor by filtering the influence of esophagus and lower esophagus sphincter (LES) so as to gather food passage events; and   c) means for processing said parameter, thereby providing an indication of a current eating pattern,   wherein said processing of said parameter is obtained according to a modification to the Navier-Stokes equation:   
       
         
           
             
               
                 
                   
                     
                       
                         ρ 
                          
                         
                           ( 
                           
                             
                               
                                 ∂ 
                                 v 
                               
                               
                                 ∂ 
                                 t 
                               
                             
                             + 
                             
                               v 
                               · 
                               
                                 ∇ 
                                 v 
                               
                             
                           
                           ) 
                         
                       
                       = 
                       
                         
                           - 
                           
                             ∇ 
                             p 
                           
                         
                         + 
                         
                           ∇ 
                           
                             · 
                              
                           
                         
                         + 
                         f 
                       
                     
                     , 
                   
                 
                 
                   
                     formula 
                      
                     
                         
                     
                      
                     
                       ( 
                       a 
                       ) 
                     
                   
                 
               
             
           
         
         where V is the flow velocity, ρ is the fluid density, p is the pressure.   is the deviatoric stress tensor, f represents body forces per unit volume acting on the fluid and ∇ is the del operator; such that the following formula is used: 
       
       
         
           
             
               
                 
                   
                     
                       
                         
                           p 
                           1 
                         
                         - 
                         
                           p 
                           2 
                         
                       
                       ρ 
                     
                     = 
                     
                       
                         1 
                         2 
                       
                        
                       
                         ( 
                         
                           
                             
                               16 
                                
                               
                                   
                               
                                
                               
                                 Q 
                                 2 
                               
                             
                             
                               
                                 π 
                                 2 
                               
                                
                               
                                 D 
                                 2 
                                 4 
                               
                             
                           
                           - 
                           
                             
                               16 
                                
                               
                                 Q 
                                 2 
                               
                             
                             
                               
                                 π 
                                 2 
                               
                                
                               
                                 D 
                                 1 
                                 4 
                               
                             
                           
                         
                         ) 
                       
                     
                   
                 
                 
                   
                     formula 
                      
                     
                         
                     
                      
                     
                       ( 
                       b 
                       ) 
                     
                   
                 
               
             
           
         
         where D 1  is the pouch diameter, D 2  is stoma diameter, P 1  is upstream pressure, P 2  is downstream pressure, Q is the volumetric flow rate and ρ is upstream density thereby obtaining said parameter. 
       
     
     
         21 . The device according to  claim 20 , additionally comprising at least one second-type external sensor; further wherein said at least one second-type external sensor is selected from a group consisting of a vertical position sensor, thermometer, thermal sensor, force transducer, or a strain gauge, weighing, oscillating sensor for mass detection or any combination thereof. 
     
     
         22 . The device according to  claim 20 , additionally comprising at least one filter adapted for filtering the influence of patient posture while eating on food passage through the GRA. 
     
     
         23 . The device according to  claim 20 , additionally comprising at least one means for calibrating the GRA to a desired restriction based on the monitored parameter. 
     
     
         24 . The device according to  claim 20 , wherein said parameter is selected from a group consisting of total size of meal, average volume of meal, average time of meal, volumetric consumption by time, shifting to liquid food consumption, vomiting events, type of food consumed, times of meals during the day, duration of meals, new adjustment validation data, short term change of pressure events as a result of new adjustment, long term change of pressure events as a result of new adjustment, average calorie of meal, segmented calorie to total calorie from Hydrocarbons, fat and protein, and any combination thereof. 
     
     
         25 . The device according to  claim 20 , wherein said at least one first-type external sensor is either (a) mounted in a position between the fingers and the elbow; or, (b) embodied in at least one element selected from a group consisting of a bracelet, hand watch belt, ring, elastic band wrapped around the arm, patch with one adhesive side, an add-on to a utensil, as an integral part of a utensil, and any combination thereof. 
     
     
         26 . The device according to  claim 20 , wherein said indication is performed by at least one selected from a group consisting of (a) the patient; (b) said physician through appropriate instructions to said patient; (c) control signal for delivery of substance such as PYY 36 or other substance; and any combination thereof.