Abstract:
A method for forming an artificial valve includes inserting a sheath having proximal and distal sections and a lumen extending therethrough orally into a body cavity; inserting an endoscope orally into a body cavity, the endoscope being slidably positioned within the sheath; holding tissue in a vicinity of a junction of a stomach and an esophagus where the artificial valve is to be formed, using a holding device extending from the sheath; penetrating through tissue of the esophagus and then through tissue of the stomach at an oral side of the junction of the stomach and the esophagus with a needle provided outside of the endoscope which is not mechanically connected to the holding device and which is moveable outside of the endoscope relative to the endoscope; and passing a binding member through the tissue of the esophagus and the tissue of the stomach using the needle.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    The present application is a divisional application of U.S. application Ser. No. 11/932,445, filed Oct. 31, 2007, which is a divisional application of U.S. application Ser. No. 10/998,242, now U.S. Pat. No. 7,318,802, filed Nov. 24, 2004, which is a continuation application of U.S. application Ser. No. 09/909,980, now U.S. Pat. No. 6,921,361, filed Jul. 23, 2001, all of which are incorporated herein by reference, and which claims the priority of U.S. Provisional patent application No. 60/220,204, filed Jul. 24, 2000. 
     
    
     FIELD OF INVENTION 
       [0002]    The present invention relates to an apparatus and a method for forming an artificial valve to treat gastroesophageal reflux disease (GERD). 
       BACKGROUND OF THE INVENTION 
       [0003]    The incidence of GERD has increased recently. The main symptoms of GERD are heartburn and mucosal breaks in the esophagus. Although it is a benign disease, GERD is accompanied by serious pain, and often requires treatment. The main cause of GERD is decreased function of the lower esophageal sphincter (LES) at the bottom of the esophagus followed by reflux of acid into the esophagus. 
         [0004]    GERD is usually treated by administration of acid secretion controlling agents such as proton-pump inhibitors. Moderate GERD will improve and may be treated completely by medication. If, however, the LES function is damaged seriously or if anatomic problems such as hiatal hernias exist, treatment with medication is less effective, and becomes costly over an extended period of time. 
         [0005]    Therefore, cases of serious GERD are often treated surgically. Effective surgical methods—including Nissen fundoplication or the Toupet method—are known and applied widely. With this method, the LES is wrapped by the stomach wall to improve its function. 
         [0006]    This method has been proven highly effective. Recently, laparoscopic surgery techniques were used with this method as a less invasive treatment. Because there are many patients, and GERD is a benign disease, these less invasive treatments are desirable. 
       DESCRIPTION OF THE RELATED ART 
       [0007]    FIG. 41 depicts a tool for transoral treatment of GERD, disclosed in U.S. Pat. No. 5,887,594. This instrument a comprises a piercing device e having an elongated portion b, a manipulation section c and a hook portion d; and a securing device i having a connector f, a manipulation section g and a securing mechanism h. The piercing device e is inserted from the mouth to the stomach of a patient, and pulled up to the esophagus, with the hook portion d fixed at the upper stomach thereby forming a fold of tissue (not shown). Then, the securing device i is inserted into the esophagus of the patient, and the securing mechanism h fixes the fold consisting of the upper stomach and the esophagus. When the fold is fixed, the intermediate portion is compressed to inward to form valve (not shown). 
         [0008]    FIGS. 42 to 46 depict another transoral treatment method of GERD, disclosed in International Patent Publication No. WO99/22649. An instrument n has a rotatable fastener head p, which is rotatable at the distal end of a flexible tube o, and the rotatable fastener head p and portion of the flexible tube o that can touch the rotatable fastener head p have a male fastener q and a female fastener r, respectively. The flexible tube o has a rotatable grasper s at the distal end, and an opening for an endoscope t to be inserted throughout the flexible tube o. First, the flexible tube o is inserted from the mouth to the stomach of the patient. The rotatable grasper s is drawn into contact with a junction v between the stomach and the esophagus. The rotatable grasper s is operated to hold the junction v. Next, the flexible tube o is advanced downward to suspend the junction v. The rotatable fastener head p is operated to penetrate the junction v with the male fastener q to engage with the female fastener r. Thus, the junction v and the middle part are compressed to be protruded inward to form a protrusion x. 
         [0009]    In the composition disclosed in U.S. Pat. No. 5,887,594, the hook portion d of the piercing device e needs to be fixed to the stomach and pulled. The gastric wall, however, is thicker than the esophagus, and is divided into three regions: the inner mucous membrane; the middle proper muscularis; and the outer serous membrane. In particular, a space between the mucous membrane and the proper muscularis has high movability. To form a protrusion into a valve, tissue including the proper muscularis should be compressed and lifted up. The hook portion d only takes the mucous membrane and cannot include the proper muscularis below it. Thus, the valve formed in this application is not large and thick enough to prevent reflux satisfactorily. 
         [0010]    In the apparatus disclosed in International Patent Publication WO99/22649, the rotatable grapser s is integral to the flexible tube o, which makes it difficult to touch the target tissue. The field of view of the endoscope t is blocked by the rotatable fastener head p, which makes difficult for the rotatable grasper s to hold and suspend the junction v between the stomach and the esophagus. Because the position between the rotatable grasper s, the male fastener q, and the female fastener r is fixed, the size of a protrusion x is limited. It is desirable, however, to form a protrusion of varying size depending on the degree of severity of GERD. The difficulty of passing food has already been reported as a complication of artificial cardia in Nissen fondoplication, and is likely to happen with an excessively large protrusion x. Even much a smaller protrusion x is effective for the treatment of the moderate GERD. With this apparatus, treatment is not flexible enough to allow a small protrusion to facilitate food flow in the case of moderate GERD. 
       SUMMARY OF THE INVENTION 
       [0011]    The first object of the present invention is to provide the apparatus and method for forming a valve including the proper muscularis below the mucous membrane to prevent gastroesophageal reflux effectively. 
         [0012]    The second object of the present invention is to provide the apparatus and method for holding and suspending the junction between the stomach and the esophagus using a holding device extending out of the distal end of an endoscope to improve the ease of the operation for forming the protrusion. 
         [0013]    The third object of the present invention is to provide the apparatus and method for forming a valve of varying size by using a separate holding device and a needle to achieve the flexible treatment method, which may be modified due to the degree of GERD severity. 
         [0014]    According to the present invention, an apparatus for forming an artificial valve to treat gastroesophageal reflux disease comprising a first endoscope to be inserted from the mouth into a body cavity; a holding device extending out of the distal end of the first endoscope and holding a point of a digestive wall where the artificial valve is formed; a first needle disposed the oral side of the point, retractable along the first endoscope and including a sharp end for penetrating from the oral side of the point to the anal side of the point; a suture passing through following the first needle; and a suture retaining device having a grasping section for grasping the suture after it has passed through the digestive wall. 
         [0015]    According to another aspect of the present invention, a treatment method for forming an artificial valve to treat gastroesophageal reflux disease comprises the following steps. Inserting an endoscope from the mouth substantially adjacent to a point of a digestive wall where the artificial valve is to be formed. Holding a point with a holding device extending out of the distal end of the endoscope. Pulling down the point held by holding device. Penetrating the digestive wall from the oral side of the point to the anal side of the point by a needle positioned along the endoscope. Passing a suture through following the needle. Shortening the digestive wall with the suture to form the artificial valve. Fixing the end of the suture to maintain the artificial valve. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0016]      FIG. 1  depicts an arrangement of the first embodiment of the present invention including a first endoscope and a second endoscope. 
           [0017]      FIG. 2  depicts a holding device of the first embodiment. 
           [0018]      FIG. 3  depicts a detail view of the distal end of the holding device of the first embodiment. 
           [0019]      FIG. 4  depicts a detail view of a pair of jaws of the holding device of the first embodiment. 
           [0020]      FIG. 5  depicts an exploded view of the connection between a sheath and a manipulation section of the holding device of the first embodiment. 
           [0021]      FIG. 6  depicts a cross-section of the connection depicted in  FIG. 5 . 
           [0022]      FIG. 7  depicts a needle tool of the first embodiment. 
           [0023]      FIG. 8  depicts a needle of the first embodiment. 
           [0024]      FIG. 9  depicts the needle tool, a needle, and a suture in a second endoscope of the first embodiment. 
           [0025]      FIGS. 10A and 10B  depict a detail view of the distal end of a suture retaining device of the first embodiment. 
           [0026]      FIG. 11  depicts a knot pusher of the first embodiment. 
           [0027]      FIGS. 12 to 27  depict steps of a treatment method using the first embodiment. 
           [0028]      FIG. 28  depicts a second embodiment of the present invention. 
           [0029]      FIGS. 29 to 30  depict a treatment method using the second embodiment. 
           [0030]      FIG. 31  depicts a third embodiment of the present invention. 
           [0031]      FIGS. 32 to 35  depict a fourth embodiment of the present invention. 
           [0032]      FIG. 36  depicts a treatment method using the fourth embodiment. 
           [0033]      FIGS. 37 to 39  depict a fifth embodiment of the present invention. 
           [0034]      FIG. 40  depicts a treatment method using the fifth embodiment. 
           [0035]      FIG. 41  depict  FIG. 3  of U.S. Pat. No. 5,887,594. 
           [0036]      FIGS. 42 to 46  depict various figures from PCT Application WO 99/22649. 
       
    
    
     DETAILED DESCRIPTION 
       [0037]      FIG. 1  illustrates the overall configuration of the first embodiment of the present invention. Apparatus  1  comprises a first endoscope  2 , holding device  11 , which may be holding grasping forceps, forceps, or any other device capable of holding the digestive wall of a body cavity, extendable out of the distal end  3  of the first endoscope  2 , a guide  5  running lengthwise on the outer periphery of the first endoscope  2 , a second endoscope  6  to be inserted parallel to the first endoscope  2 , a needle tool  40  retractable at the distal end  7  of the second endoscope  6 , a sheath  84  in which the first endoscope  2  and the second endoscope  6  are retractably inserted, a suture  46  retractably insertable in a lumen  8  of the needle tool  40 , suture retaining device  50 , which may be forceps, suture grasping forceps, or any other device capable of grasping sutures, to be inserted in a lumen  9  of the guide  5  and movable in relation to the first endoscope  2 , and a knot pusher  61  to be used with the first endoscope  2  or second endoscope  6 . Each member of the first embodiment is described as follows. 
         [0038]      FIGS. 2 to 6  depict the first endoscope  2  and holding device  11  of the first embodiment. The holding device  11  comprise a distal portion  12 , a sheath  14  fixed at the proximal end of the distal portion  12  and inserted in a channel  13  of the endoscope  2 , and an manipulation section  15  fixed detachably at the proximal end of the sheath  14  for operating the distal portion  12 . In the distal portion  12 , a pair of jaws  17   a  and  17   b,  which may be forcep jaws, are fixed pivotally with a pin  18  to a cover  16  and via links  19   a  and  19   b  to a cable anchor  20 . A cable  21  is fixed to the cable anchor  20 , and inserted in the sheath  14 . The cable  21  is fixed detachably to a sliding part  22  of the manipulation section  15 . A slider handle  23  is fixed to the sliding part  22 , and is translated lengthwise in relation to the manipulation section  15 . 
         [0039]    The distal portion  12  has a larger outside diameter than the channel  13  of the first endoscope  2 . The jaws  17   a  and  17   b  have a plurality of teeth  24   a  and  24   b  for grasping tissue securely, which engage each other when the jaws  17   a  and  17   b  are in a closed position. To minimize damage to tissue when it is grasped, the surface of the teeth  24   a  and  24   b  are smooth with a minimum amount of sharp edges. The jaws  17   a  and  17   b  have longitudinal grooves  25   a  and  25   b  to permit tissue to escape when it is grasped securely, and to prevent tissue from collapsing. 
         [0040]    The slider handle  23  has a serrated part  26 , which is retractable. The sliding surface  27  of the manipulation section  15  has serrations  28 . Together the serrated part  26  and the serrations  28  act as ratchet mechanism. 
         [0041]    A hook  30  is fixed to the proximal end  29  of the cable  21 , and is inserted into a hole  31  of the slider handle  23 . Threads  32  are formed vertically in the hole  31 . The hook  30  is fixed in the hole  31  by screwing a knob  33  to engage the hook  30 . 
         [0042]    The sheath  14  has two catches  70  and  71  at the proximal end, which may be arranged diametrically from each other. The manipulation section  15  has an introduction hole  72  in the axial direction at the distal end to accommodate the sheath  14 . Two engagement holes  73  and  74  are disposed within the walls of the introduction hole  72  to engage with the catches  70  and  71 . Outside of each of the engagement holes  73  and  74 , there are deformable latches  75  and  76 , that press the catches  70  and  71  through the engagement holes  73  and  74 . 
         [0043]      FIGS. 7 to 9  depict the second endoscope  6 , needle tool  40 , and suture  46  of the first embodiment. The needle tool  40  comprises a sheath  42  to be inserted in the channel  41  of the second endoscope  6 , a manipulation section  43  disposed at the proximal end of the sheath  42 , a needle  44  sliding in the lumen of the sheath  42 , a grip  45  fixed to the proximal end of the needle  44 , and a suture  46  to be inserted slidably in the lumen of the needle  44 . The needle  44  may be made of stainless steel or any material having sufficient flexibility to withstand proximal pressure and adapt to the bending of the endoscope, such materials include super elastic alloys including nickel titanium alloy. The manipulation section  43  comprises a body  80 , a sheath sliding section  81 , and a needle sliding section  82 , which slides in the longitudinal direction. The distal end of the sheath sliding section  81  is fixed to the proximal end of the sheath  42 . The grip  45  of the needle  44  is fixed detachably to the proximal end of the needle sliding section  82 . The manipulation section  43  has at the distal end a connecting section  49  to be fixed detachably to a channel clasp  48  of the handle  47  of the endoscope  6 . 
         [0044]    The suture  46  may made of durable, slidable material capable of sliding smoothly in the lumen  8  of the needle  44 , such as nylon monofilament or multifilament coated with fluoroplastics. 
         [0045]      FIGS. 10A and 10B  depict the suture retaining device  50  of the first embodiment. The suture retaining device  50  is slidably insertable in the lumen  9  of the guide  5 , which is fixed on the outer periphery of the first endoscope  2 . A distal section  51  has jaws,  52   a  and  52   b,  which may be forcep jaws with an opening and closing position. The jaws  52   a  and  52   b  each have a plurality of small protrusions  54   a  and  54   b  for preventing the suture  46  from slipping off the grasping surfaces  53   a  and  53   b.  The distal section  51  has, at the proximal end, a sheath  55  following the curve of the first endoscope  2  and a wire  56  capable of translating longitudinally in the sheath  55 . The wire  56  has a slider handle  57  at the proximal end, and the sheath  55  has a manipulation section  58  at the proximal end. The slider handle and the manipulation section have, like the holding device  11 , a serrated part (not shown) and serrations (not shown), which together act as a ratchet mechanism. 
         [0046]      FIG. 11  depicts a knot pusher  61  comprising a distal end  62 , a sheath  63  to be inserted in the channel  13  or  41  of the first endoscope  2  or second endoscope  6 , and a knob  64  for pressing the distal end  62  in the longitudinal direction. The distal end  62  has a slit  65  for engaging the suture  46 . 
         [0047]      FIGS. 2 to 9  further depict assembly of the first embodiment. The hook  30 , the cable  21 , and the sheath  14  are inserted into the channel  13  from the distal end  3  of the first endoscope  2 . Next, the hook  30 , extending out of the proximal end of the first endoscope  2 , is inserted in the hole  31  of the sliding part  22 . The knob  33  of the slider handle  23  is screwed into the threads  32  in the slider handle  23  to hold and engage the hook  30  with the sliding part  22 . Then, the sheath  14  is inserted in the introduction hole  72  of the manipulation section  15  to deform the catches  70  and  71  inward and diametrically to be housed in the introduction hole  72 . The catches  70  and  71  deform diametrically outward to engage the engagement holes  73  and  74 . At this point, the sheath  14  and the manipulation section  15  are fixed. 
         [0048]    The guide  5  is fixed on the outer periphery  4  of the first endoscope  2  at several points using a medical tape. The suture  46  is inserted in the lumen  8  of the needle tool  40 . 
         [0049]    The grip  45  is pulled proximally so that the needle  44  or the suture  46  is withdrawn in the distal end of the needle tool  40 . The sheath  42  is inserted from the channel clasp  48  of the second endoscope  6  to the channel  41  until the distal end of the sheath  42  extends out of the distal end of the endoscope  6 . Then the body  80  is fixed to the channel clasp  48  of the endoscope  6 . 
         [0050]      FIGS. 12 to 14  depict holding and suspending of the cardia using the apparatus of the first embodiment. The sheath  14  of the holding device  11  is drawn proximally to withdraw only the distal portion  12  in the distal end  3  of the first endoscope  2 . The first endoscope  2  covered by the sheath  84  is inserted into the body cavity of a patient. Because the distal portion  12  is also covered by the sheath  84 , the endoscope  2  can be inserted without any trauma of to the patient&#39;s tissue. The first endoscope  2  is inserted into the stomach of the patient, and withdrawn from the sheath  84 , then, the distal end  3  is bent upwards to face the cardia  90 . 
         [0051]    The slider handle  23  is pressed distally against the manipulation section  15  (not shown in  FIGS. 12 to 14 ). The hook  30 , the cable  21 , and the cable anchor  20  are translated distally to rotate the links  19   a  and  19   b,  and in turn, the jaws  17   a  and  17   b  around the pin  18  to open the jaws  17   a  and  17   b.  The sheath  14  is moved forward to bring the jaws  17   a  and  17   b  into contact with the tissue  91  in the side of the greater curvature of the stomach at the cardia  90 . 
         [0052]    The slider handle  23  is pulled proximally to close the jaws  17   a  and  17   b.  The tissue  91  is held and pressed by the jaws  17   a  and  17   b,  but will not collapse to overflow from the longitudinal grooves  25   a  and  25   b  or because the teeth  24   a  and  24   b  are not sharp. The serrated part  26  of the slider handle  23  is extended against the sliding surface  27  of the manipulation section  15 , and engaged with the serrations  28  to limit distal movement of the slider handle  23 . The jaws  17   a  and  17   b  hold and fix the tissue  91 , once it is held, even if the slider handle  23  or the manipulation section  15  is not held by physician. 
         [0053]    The first endoscope  2  is inserted deeply into the body to suspend the first endoscope  2  and the holding device  11 . The distal portion  12  has a larger outside diameter than the channel  13  of the first endoscope  2 . The jaws  17   a  and  17   b  are wide and long, and the tissue  91  is suspended and fixed by the jaws  17   a  and  17   b.    
         [0054]      FIGS. 15A ,  15 B,  16 A and  16 B depict penetrating the gastric and esophagus walls using the first embodiment. The second endoscope  6  is inserted parallel to the first endoscope  2 . The distal end of the second endoscope  6  is positioned at a point  92  above the junction between the stomach and the esophagus while it is observed by the second endoscope  6 . Then the second endoscope  6  is manipulated to bend the distal end  7  slightly toward the side of the greater curvature of the stomach. The sliding section  81  is moved distally against the body  80  to extend the sheath  42  out of the distal end  7  of the second endoscope  6 , and to press an entering point  93   a.    
         [0055]    The grip  45  is pressed forward to extend the needle  44  out of the sheath  42 . Because the greater curvature of the stomach at the cardia  90  has already been held by the holding device  11  and suspended with the first endoscope  2 , the needle  44  pierces from the entering point  93   a  through the mucous membrane  94 , continuing at least through the proper muscularis  95  of the esophagus, then through the proper muscularis  96  of the stomach, and then through the mucous membrane  97  of the stomach, and exiting out of an exiting point  98   a  of the cardia. 
         [0056]    Next, the first endoscope  2  is inserted deeper in the body, and the tissue  91  is suspended lower, the needle  44  passes the entering point  93   b,  the mucous membrane  94  of the esophagus, the proper muscularis  95  of the esophagus, the abdominal cavity  99 , the serous membrane  100  of the stomach, the proper muscularis  96  of the stomach, the mucous membrane  97  of the stomach, and the exiting point  98   b  at the cardia. 
         [0057]    The first endoscope  2  checks that the needle  44  comes out in the stomach. 
         [0058]      FIGS. 17 and 18  depict inserting and pulling the suture with the first embodiment. The suture retaining device  50  is inserted in the guide  5  and extended out in the stomach of the patient. The process is observed by the first endoscope  2 . The suture  46  is pressed in the needle  44 , and extended out in the stomach. With the suture retaining device  50  drawn into contact with the suture  46 , the slider handle  57  is moved forward against the manipulation section  58  to open the jaws  52   a  and  52   b.  The suture  46  is held by the jaws  52   a  and  52   b.  The slider handle  57  is moved proximally against the manipulation section  58  to close the jaws  52   a  and  52   b.  The suture  46  is held by the small protrusions  54   a  and  54   b  on the grasping surfaces  53   a  and  53   b  of the jaws  52   a  and  52   b.  The jaws  52   a  and  52   b  are designed to minimize the chances that the suture  46  will slip off, or be cut or damaged. When the serrated part of the slider handle  57  is engaged with the serrations of the manipulation section  58 , distal movement of the slider handle  57  will not be limited. Therefore, the jaws  52   a  and  52   b  hold and fix the suture  46  with hands-free operation of the slider handle  57  or the manipulation section  58 . Next, the suture retaining device  50  is withdrawn from the guide  5  together with the suture  46 . The serrated part  26  of the holding device  11  is lifted to disengage from the serrations  28 . The slider handle  23  is moved forward to open the jaws  17   a  and  17   b  to release the tissue  91 . 
         [0059]    The steps illustrated in  FIGS. 17 and 18 , and discussed above, are repeated to pass two sutures  46   a  and  46   b  through the following points: from outside the body, the channel  13  of the first endoscope  2 , the patient tissue of the esophagus and the stomach, inside the guide  5 , outside the body. The endoscopes  2  and  6  are withdrawn with the sutures  46   a  and  46   b  remaining in the body cavity. The resulting configuration is shown in  FIG. 19 . 
         [0060]      FIGS. 19 to 22  depict formation of the artificial valve using the first embodiment. The suture  46   a  has ends  101   a  and  101   b;  the suture  46   b  has ends  102   a  and  102   b.  The ends  101   a  and  102   a,  which are on the side of the stomach, are tied to each other outside the patient&#39;s body. The free ends  101   b  and  102   b,  which are on the side of the esophagus, are pulled to draw the ends  101   a  and  102   a  into the body cavity. The ends  101   a  and  102   b  adjoin, and are fixed at exiting points  98   a  and  98   b  of the stomach. Then the ends  101   b  and  102   b  are pulled further to bring the gastric wall near the exiting points  98   a  and  98   b  close to entering points  93   a  and  93   b  in the esophagus. Thus, a junction  103  of the stomach and the esophagus between the exiting points  98   a  and  98   b  and the other entering points  93   a  and  93   b  is shortened to form an internal protrusion  104 . 
         [0061]      FIGS. 23 to 27  depict fixing the sutures with the first embodiment. The ends  101   b  and  102   b  of the sutures  46   a  and  46   b  are tied outside the body to form a knot  105 . The knot pusher  61  is inserted in the channel  41  of the second endoscope  6 , and its distal end  62  is extended out of the distal end of the second endoscope  6 . With the knot  105  engaged on the slit  65 , the second endoscope  6  and the knot pusher  61  are inserted into the body cavity. Then, the ends  101   b  and  102   b  of the sutures are pulled to move the knot  105  and the second endoscope  6  into the body cavity. As seen in  FIG. 25 , when the knot  105  reaches the entering points  93   a  and  93   b  of the esophagus, the distal end  62  is pressed against the entering points  93   a  and  93   b  while the ends  101   b  and  102   b  are pulled to fix the knot  105 . The above step is repeated several times to prevent the knot  105  from loosening. After the knot  105  is fixed firmly, the second endoscope  6  and the knot pusher  61  are withdrawn out of the body cavity. The excess sutures  46   a  and  46   b  beyond the knot  105  are cut using endoscopic scissors (not shown), and are collected to finish the process. Depending on the patient&#39;s symptoms, the above process will be repeated to form a plurality of stitches  106  to  109 , as illustrated in  FIG. 27 , to form a larger protrusion. 
         [0062]    The holding device  11  inserted in the first endoscope  2  allows suspension of the tissue  91  while it is held and fixed securely. Because the distal portion  12  is formed larger than the channel  13  of the endoscope  2 , the jaws  17   a  and  17   b  are long and wide enough to hold and suspend a large area of the tissue  91  without damaging it. Therefore, the needle  44  can pierce deep into the proper muscularis. A large protrusion including the proper muscularis of the stomach and the esophagus is formed as artificial valve for preventing reflux effectively. 
         [0063]    Because the holding device  11  extends out of the distal end of the endoscope  2 , the jaws  17   a  and  17   b  touch the tissue  91  easily while it is observed by the first endoscope  2 . The process is simple for the operator to perform, and requires a short time. 
         [0064]    Because both the second endoscope  6  and the needle tool  40  are provided separately from both the first endoscope  2  and the holding device  11 , the operator independently controls suspension of the cardia and the positions of the entering points  93   a  and  93   b  to form valves of varying size according to the patient&#39;s particular symptoms. 
         [0065]    In the first embodiment, the second endoscope or the needle is provided separately from the first endoscope or the fixing means. The operator controls at discretion suspension of the tissue or the entering point of the needle to form a valve of different size according to the symptom of a patient. 
         [0066]      FIGS. 28 to 30  depict the second embodiment of the present invention. The same components as the first embodiment are indicated by the same numbers, and their description will be omitted. 
         [0067]    In the second embodiment, a needle tool  110  is composed as follows. Two sheaths  111   a  and  111   b  are fixed at the distal ends  112   a  and  112   b  parallel to the distal end  113  of the second endoscope  6 . The sheaths  111   a  and  111   b  are fixed at the proximal portion on the outer periphery of the second endoscope  6  using medical tape at several points. The two sheaths  111   a  and  111   b  are fixed to the manipulation section  114  and accommodate needles  115   a  and  115   b,  which slide inside. Grips  116   a  and  116   b  are fixed to the proximal ends of the needles  115   a  and  115   b  and connected to connecting section  117  which is detachable. 
         [0068]    After the first endoscope  2  or the holding device  11  holds and suspends the tissue  91 , the endoscope  6  and the needle tool  110  fixed to the endoscope  6  are inserted into the body cavity of a patient. The endoscope  6  is operated to bring the distal ends of the sheaths  111   a  and  111   b  to contact with the entering points  93   a  and  93   b  and press the grips  116   a  and  116   b  to pierce the needles  115   a  and  115   b.    
         [0069]    The sutures  46   a  and  46   b  extend out of the needles  115   a  and  115   b  and are held and collected by the suture retaining device  50 . 
         [0070]    In addition to the features of the first embodiment, the second embodiment also is capable of inserting two sutures  46   a  and  46   b  are inserted at one time. In contrast, using the first embodiment an operator must set the appropriate direction and position of the second entering point  93   b  relative to the first entering point  93   a.  This takes more time and is more difficult to perform. The second embodiment is simpler in operation and takes much shorter time than the first embodiment because the two sutures  46   a  and  46   b  are inserted parallel to a certain distance at one time. 
         [0071]      FIG. 31  depicts the third embodiment of the present invention. The same components as the first embodiment are indicated by the same numbers, and their description will be omitted. 
         [0072]    In the third embodiment, a needle  120  does not have a lumen. Instead, a suture  121  is inserted and fixed in a through hole  122  of the needle  120 . 
         [0073]    The needle  120  pierces the tissue with the suture  121  inserted and fixed in the through hole  122 . The suture grasping forceps  50  pulls the suture  121  out of the through hole  122  and removed through the guide  5  out of the body. 
         [0074]    In addition to the effect of the first embodiment, because it is not necessary to insert the suture  121  in the needle, the needle  120  is thinner than the hollow needle  44  in the first embodiment. The needle  120  can be tapered to have a sharp tip, which pierces the tissue with smaller force to improve operability. 
         [0075]      FIGS. 32 to 36  depict the fourth embodiment of the present invention. The same components as the first embodiment are indicated by the same numbers, and their description will be omitted. 
         [0076]    In the forth embodiment, an endoscope  140  has an optical system capable of viewing in the side direction. A channel  141 , which opens on the side, has an elevator  143  near a distal exit hole  142  for changing the direction of a tool, such as the holding device  11 , as it exits the distal exit hole  142 . The orientation of the tool exiting the distal exit hole  142  can be changed from the axial (axis of the endoscope  140 ) direction to the side direction by advancing or withdrawing a wire  144  fixed to the elevator  143 . 
         [0077]    The holding device  11  is mounted to the endoscope  140  and inserted into the stomach of a patient. The distal end of the endoscope  140  is rotated by about 90 degrees to observe the cardia  90 . The wire  144  is pulled to rotate and lift the elevator  143 , thus directing the distal portion  12  of the grasping forceps toward the cardia. The grasping forceps  11  are operated to grasp the target tissue  91 . 
         [0078]    In addition to the effect of the first embodiment, without inversion of the endoscope  140  in the stomach, the front view of the cardia  90  is observed using the endoscope  140  and the holding device  11  grasps and fixes the target tissue. Therefore, even if a patient has lost a part of the stomach due to another disease, and the stomach is too small to allow inversion of the endoscope  2 , the present invention is effective to treat gastroesophageal reflux disease. 
         [0079]      FIGS. 37 to 40  depict the fifth embodiment of the present invention. The same components as the first embodiment are indicated by the same numbers, and their description will be omitted. 
         [0080]    In the fifth embodiment, the first and second endoscopes  2  and  6  are replaced by an integrated endoscope  150 . The endoscope  150  has a first optical system  151  and a second optical system  152 . The endoscope  150  has the first optical system  151  and holding device  154  at the distal end  153 . A suture retaining device  155  is mounted retractably at the distal end  153 . 
         [0081]    The second optical system  152  as well as an exiting hole  158  of a needle  157  is provided at the proximal portion of the distal bendable section  159  of the endoscope  150  and is movable in the longitudinal direction. The exiting hole  158  is disposed near the elevator  160 , and is rotated by a wire  161  fixed to the elevator  160  to change the exiting direction. 
         [0082]    The endoscope  150  is inserted into the body of a patient until the distal end  153  enters the stomach. The endoscope  150  is manipulated to bend the distal bending section  159  to invert the distal end  153  so that it faces a direction substantially upwards. After the first optical system  151  observes the cardia  90 , an actuator opens grasping forceps  154  to touch the tissue  91 . Then the actuator closes the forceps  154  to fix the tissue  91 . Next, the endoscope  150  is advanced deeper to suspend the cardia  90 . 
         [0083]    The second optical system  152  and the exiting hole  158  are moved in the longitudinal direction. While the area above the junction between the stomach and the esophagus is observed, the elevator  160  is operated to bring the exiting hole  158  into contact with the entering point  93 . The needle  157  pierces the tissue and comes out of the exiting hole  158 . 
         [0084]    The suture  46  is extended out of the needle  157 , and held and fixed by the suture retaining device  155  which extends out of the distal end  153  under observation of the first optical system  151 . 
         [0085]    With the suture  46  remaining in the tissue, the endoscope  150  is withdrawn. 
         [0086]    The effects of the fifth embodiment are similar to those of the first embodiment. In addition, because only the integrated endoscope  150  is inserted into a patient (as opposed to inserting a first endoscope  2  and a second endoscope  6  as with the first embodiment), the device is operated by one operator, and treatment is simple and takes a shorter time.