Abstract:
A method for the appetite suppression of an individual comprising the steps of introducing a bulking material between the vagal nerve area and the stomach wall of a patient undergoing appetite suppression treatment to reduce production levels of ghrelin in the patient&#39;s system.

Description:
BACKGROUND OF THE INVENTION  
       [0001]     Field of the Invention  
         [0002]     This invention relates to a treatment for reducing the appetite of a patient needing weight loss and more particularly to a medical arrangement related to effecting the vagal nerve to suppress appetite, and is based upon Provisional patent application 60/582,056, filed Jun. 22, 2004, and is incorporated herein by reference in its entirety.  
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
    
    
       [0003]     The objects and advantages of the invention will become more apparent when viewed in conjunction with the following drawings, in which:  
         [0004]      FIG. 1  is a representation of a human stomach in a side elevational view;  
         [0005]      FIG. 2  is a view similar to  FIG. 1 , showing the vagal nerve trunk in the lesser curvature of the stomach;  
         [0006]      FIG. 2A  is an enlarged representation of the vagal trunk serusa and stomach wall shown in  FIG. 2 , in a sectional view;  
         [0007]      FIG. 3  is a sectional view of the gastroesophageal junction, again showing the vagal nerve trunk;  
         [0008]      FIG. 4  is an enlarged sectional view of the stomach wall and vagal nnerve trunk with a gastroscope introducing a bulking agent into a site adjacent the vagal nerve trunk to compress and displace the vagal nerve;  
         [0009]      FIG. 5  is an enlarged sectional view of the stomach wall and vagal nerve with a bulking agent disposed therebetween;  
         [0010]      FIG. 6  is a sectional view of a distended stomach;  
         [0011]      FIG. 6A  is an enlarged sectional view of an emplaced bulking agent represented in a portion of the distended stomach shown in  FIG. 6 ;  
         [0012]      FIG. 7  is a sectional view of a contracted stomach;  
         [0013]      FIG. 7A  is an enlarged sectional view of an emplaced bulking agent represented in a portion of the contracted stomach shown in  FIG. 6 ;  
         [0014]      FIG. 8  is a sectional view representing an electrical pulse generator implanted in the abdominal wall;  
         [0015]      FIG. 8   a  is an enlarged sectional view of an implanted electrical pacemaker electrode shown in  FIG. 8 , adjacent the vagal nerve;  
         [0016]      FIG. 9   a  is a sectional view of a preprandial (before meal) stomach;  
         [0017]      FIG. 9B  is a sectional representation of ghrelin cells and ghrelin in the gastric layer of the stomach represented in  FIG. 9A ;  
         [0018]      FIG. 9C  is a sectional view of an enlarged “hungry” stomach which is empty;  
         [0019]      FIG. 9D  is a sectional representation of empty “spent” ghrelin cells and a ghrelin hormone as it is released into the bloodstream to create hunger and appetite at the hypothalmus in the brain;  
         [0020]      FIG. 10A  is a sectional representation of the ghrelin cells in the gastric layer of a stomach, depicting 90% of those cells being capable of producing ghrelin (before the vagal nerve trunk bulking)  
         [0021]      FIG. 10   b  is a sectional representation of the ghrelin cells in the gastric layer of a stomach, depicting only 70% of the ghrelin cells capable of producing ghrelin, 30% of the ghrelin cells becoming atrophied one month after vagal nerve bulking, because of decreased drawing power of ghrelin through the vagal trunk; and  
         [0022]      FIG. 10C  is a sectional representation of the ghrelin cells in the gastric layer of a stomach, depicting only 40% of the ghrelin cells capable of producing ghrelin, with 60% of the ghrelin cells atrophied and inactive after three months from a vagal nerve trunk bulking procedure.  
     
    
     BRIEF SUMMARY OF THE INVENTION  
       [0023]     The present invention relates to a medical procedure wherein the Vagal nerve, in the area of the lesser area of the stomach of a patient needing appetite suppression, has a bio-compatable bulking agent introduced between the trunk of the Vagal nerve and the glandular layer of the stomach wall at the lesser curvature of the stomach.  
         [0024]     The bulking material effects a displacement of the Vagal nerve and the bulking material also effects a compression of that Vagal nerve. Such compression and displacement of the Vagal nerve has the effect of suppressing the production of Ghrelin cells which are otherwise introduced into the bloodstream and which otherwise increase an individual&#39;s appetite.  
         [0025]     Further embodiment of invention is where vagal nerve overide is accomplished by electromechanical pacing, for example a piezoelectric implant to effect the biomaterial, and create electrical energy during stomach contractions. This interferes with the normal electrical impulses of the vagus nerve.  
         [0026]     The invention thus comprises a method for the appetite suppression of an individual comprising one or more of the steps of: introducing a bulking material between the vagal nerve area and the stomach wall of a patient undergoing appetite suppression treatment to reduce production levels of ghrelin, wherein the vagal nerve area comprises the vagal trunk and the glandular layer of the stomach. The vagal nerve area may also comprise the vagal nerve arrayed in the lesser curvature of the stomach. The steps may include introducing a gastroscope through the gastroesophageal junction of a patient so as to inject a bulking agent adjacent the vagal nerve trunk to displace and compress the vagal nerve to reduce ghrelin levels in the patient&#39;s bloodstream.  
         [0027]     The invention may also include a method for the appetite suppression of a patient, comprising displacing the vagal nerve trunk of the patient to effect a reduction in ghrelin levels in the system of the patient.  
         [0028]     The invention may also include a method for the appetite suppression of a patient comprising: compressing the vagal nerve trunk of a patient to effect a reduction in ghrelin levels in the system of the patient via piezoelectric stimulation.  
       DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS  
       [0029]     Referring now to the drawings in detail, and particularly to  FIG. 1 , there is shown a representation of a human stomach  20  in a side elevational view with the esophagus  22  in communication therewith. A right and a left vagus trunk  24  and  26  are represented extending through the esophagus  22  and joining the lesser curvature  30  of the stomach  20 . The vagus nerve  32  is shown with nerve branches  34  which innervate the entire stomach  20 . In the lesser curvature of the stomach  30 , the right and left vagal trunks  24  and  26  course parallel to one another, and are referred to as the “pacemaker” of the stomach. In  FIG. 2  shows a view similar to  FIG. 1 , showing the vagal nerve trunks  24  and  26  joining in the lesser curvature  30  of the stomach  20 .  FIG. 2A  represents an enlarged representation of the vagal trunk serusa and stomach wall shown in  FIG. 2 , in a sectional view, with the right vagal trunk  24  and serosa  34  on the muscular layer  36  of the wall of the stomach  20 .  
         [0030]     In  FIG. 3  is shown a sectional view of the gastroesophageal junction  38 , disclosing placement of an enteryx bio material  39  theresurrounding, typically for the treatment of gastro esophageal reflux disease (GERD), and again showing the right vagal nerve trunk  24 .  
         [0031]      FIG. 4  discloses an enlarged sectional view of the stomach wall and a vagal nerve trunk  24  with a gastroscope  40  through the esophagus  22 , introducing a bulking agent  42  through a needle  44  into a site adjacent the vagal nerve trunk  24  and/or  26  to compress and displace the vagas nerve  32  and/or trunks  24  and  26 . Placement of a bulking biomaterial  42  compresses the vagal nerve  32  trunks  24  and  26  in the lesser curvature  30  of the stomach  20 . The bulking material  42  also displaces the vagal nerve trunks  24  and  26 .  
         [0032]      FIG. 5  shows an enlarged sectional view of the stomach wall and vagal nerve  32  with a bulking agent  42  disposed between the vagal nerve  32  or  24 / 26  and the glandular layer  27 , compressing and displacing the vagal nerve trunks  24 / 26  at the “pacemaker” of the stomach  20 .  FIG. 6  shows a sectional view of a distended stomach  20 .  FIG. 6A  shows an enlarged sectional view of an emplaced bulking agent  42  represented in a portion of the distended stomach  20  shown in  FIG. 6 . The view in  FIG. 7  is a sectional view of a stomach  20  in a contracted state, with the greater curvature  48  and the lesser curvature  30  shown.  FIG. 7A  represents an enlarged sectional view of an emplaced bulking agent  42  represented in a portion of the contracted stomach shown in  FIG. 6 , biasing both the vagal nerve trunk  24 / 26  and the mucosa  50  during a stomach contraction.  
         [0033]     The piezoelectric effect, which here is a mechanical deformation of the bulking biomaterial creates electromechanical energy to both stimulate and “pace” the vagus nerve trunks  24 / 26  as would an implanted electrical pacemaker  49  as represented in  FIG. 8 , showing a sectional view representing an electrical pulse generator implanted in the abdominal wall.  FIG. 8   a  shows this as an enlarged sectional view of an implanted electrical pacemaker electrode  52  shown in  FIG. 8 , adjacent the vagal nerve  24 / 26 .  
         [0034]     The  FIG. 9   a  shows a sectional view of a preprandial (before meal) stomach  20 , with  FIG. 9B  representing a sectional representation of ghrelin cells  54  and ghrelin  56  in the gastric layer  58  of the stomach  20  represented in  FIG. 9A .  FIG. 9C  shows a sectional view of an enlarged “hungry” stomach  20  which is empty, and  FIG. 9D  represents a sectional view of empty “spent” ghrelin cells  60  and a ghrelin hormone  56  as it is released into the bloodstream  62  to create hunger and appetite at the hypothalmus in the person&#39;s brain.  
         [0035]      FIG. 10A  is a sectional representation of the ghrelin cells  54  in the gastric layer  58  of a stomach  20 , depicting about 90% of those cells  54  being capable of producing ghrelin  56  (before “bulking” of the vagal nerve trunk  24 / 26 ).  FIG. 10   b  shows a sectional representation of the ghrelin cells  54  in the gastric layer  58  of a stomach  20 , depicting only about 70% of the ghrelin cells  54  capable of producing ghrelin  56 , about 30% of the ghrelin cells  54  becoming atrophied at a time of about one month after the vagal nerve bulking process, because of a decreased drawing power of ghrelin  56  through the vagal trunk  24 / 26 .  FIG. 10C  shows a sectional representation of the ghrelin cells  54  in the gastric layer  58  of a stomach  20 , depicting only about 40% of the ghrelin cells  54  capable of producing ghrelin  56 , showing about 60% of the ghrelin cells  54 ′ atrophied and inactive after about three months time as a result of the inventive vagal nerve trunk bulking procedure of the present invention.