Abstract:
An instrument for fastening tissue within a body includes an elongated tube having a proximal end for extending outside of the body and a distal end for positioning proximate the tissue; and a distal member configured to fold the tissue together. The distal member includes a first member having a proximal end coupled to the distal end of the tube; and a second member pivotably coupled to the distal end of the first member. The first and second members are configured to install at least one fastener. A grasper is coupled to at least one of the first member and the second member. The second member is pivotable between an open position for receiving tissue and a closed position for folding tissue therebetween. The grasper is configured to project outward from at least one of the first member and the second member when in the open position.

Description:
BACKGROUND OF THE INVENTION 
       [0001]    1. Field of the Invention 
         [0002]    The invention relates to an endoscopic surgical instrument. More particularly, the invention relates to a flexible instrument for the transoral invagination and fundoplication of the stomach to the esophagus. 
         [0003]    2. State of the Art 
         [0004]    Gastroesophageal fundoplication is a procedure for the treatment of gastroesophageal reflux disease (GERD), a condition in which gastric acids are regurgitated into the esophagus resulting in esophagitis, intractable vomiting, asthma, and aspiration pneumonia. The fundoplication procedure involves wrapping the fundus of the stomach around the lower end of the esophagus and fastening it in place. Traditionally, this procedure is accomplished via open surgery with the use of sutures to secure the plicated fundus of the stomach around the esophagus without penetrating (incising) the stomach. 
         [0005]    U.S. Pat. No. 5,403,326 to Harrison et al. discloses a method of performing endoscopic fundoplication using surgical staples or two-part surgical fasteners. The procedure disclosed by Harrison et al. involves performing two percutaneous endoscopic gastrotomies (incisions through the skin into the stomach) and the installation of two ports through which a stapler, an endoscope, and an esophageal manipulator (invagination device) are inserted. Under view of the endoscope, the esophageal manipulator is used to pull the interior of the esophagus into the stomach. When the esophagus is in position, with the fundus of the stomach plicated, the stapler is moved into position around the lower end of the esophagus and the plicated fundus is stapled to the esophagus. The process is repeated at different axial and rotary positions until the desired fundoplication is achieved. While, the procedure disclosed by Harrison et al. is a vast improvement over open surgery, it is still relatively invasive requiring two incisions through the stomach. Moreover, the procedure requires the manipulation of two different tools in order to position the fundus and to secure the fundus to the esophagus. 
         [0006]    U.S. Pat. No. 5,571,116 to Bolanos et al. discloses a non-invasive treatment of gastroesophageal reflux disease which utilizes a remotely operable invagination device and a remotely operable surgical stapler, both of which are inserted transorally through the esophagus. According to the methods disclosed by Bolanos et al., the invagination device is inserted first and is used to clamp the gastroesophageal junction. The device is then moved distally, pulling the clamped gastroesophageal junction into the stomach, thereby invaginating the junction and involuting the surrounding fundic wall. The stapler is then inserted transorally and delivered to the invaginated junction where it is used to staple the fundic wall. 
         [0007]    Bolanos et al. disclose several different invagination devices and several different staplers. Generally, each of the staplers disclosed by Bolanos et al. has an elongate body and a spring biased anvil which is rotatable approximately 15° away from the body in order to locate the invaginated gastroesophageal junction between the body and the anvil. The body contains a staple cartridge holding a plurality of staples, and a staple firing knife. Each of the invagination devices disclosed by Bolanos et al. has a jaw member which is rotatable at least 45° and in some cases more than 90° to an open position for grasping the gastroesophageal junction. One of the chief disadvantages of the methods and apparatus disclosed by Bolanos et al. is that the stapler and the invagination device must be both be present in the esophagus at the same time. With some of the embodiments disclosed, the presence of both instruments is significantly challenged by the size of the esophagus. In all of the embodiments, the invagination device is always laterally spaced apart from the stapler. Thus, the stapler cannot staple the invaginated tissue, per se, but can only staple tissue which is laterally adjacent to the invaginated tissue. The relatively small rotational movement of the anvil of the stapler further complicates the accommodation of tissue adjacent to the invaginated tissue. In addition, surgical staples have some inherent disadvantages as compared to other fasteners. The relatively small surface area of surgical staples allows them to pass through tissue over time, thereby unfastening the tissue and allowing the staples to migrate to other parts of the body. Bolanos et al. appears to recognize this disadvantage and proposes the application of a bolster or pledger to the tissues prior to stapling. Bolanos et al. do not explain how this can be accomplished transorally using the apparatus disclosed. In addition, while Bolanos et al. make a broad reference to other types of fasteners, the substantial size constraints imposed on the apparatus which are delivered transorally would seem to prohibit any type of fastener other than the staples shown by Bolanos et al. The actuating mechanism of the device disclosed by Bolanos et al. is somewhat awkward. In particular, the stapler anvil is biased to the open position, and it is not clear whether or not the stapler anvil can be locked in a closed position without continuously holding down a lever. In addition, it appears that the staple firing trigger can be inadvertently operated before the anvil is in the closed position. This would result in inadvertent ejection of staples into the stomach or the esophagus of the patient. 
       SUMMARY OF THE INVENTION 
       [0008]    It is therefore an object of the invention to provide an endoscopic surgical instrument for invagination and fundoplication of the stomach to the esophagus. 
         [0009]    It is also an object of the invention to provide an endoscopic surgical instrument for invagination and fundoplication of the stomach to the esophagus which is minimally invasive. 
         [0010]    It is another object of the invention to provide an endoscopic surgical instrument for invagination and fundoplication of the stomach to the esophagus utilizing fasteners which do not require bolsters or pledgers. 
         [0011]    It is a further object of the invention to provide an endoscopic surgical instrument for invagination and fundoplication of the stomach to the esophagus which is delivered transorally to the surgical site. 
         [0012]    It is an additional object of the invention to provide an endoscopic surgical instrument for invagination and fundoplication of the stomach to the esophagus which is capable of plicating tissue directly in line with invaginated tissue. 
         [0013]    Yet another object of the invention is to provide an endoscopic surgical instrument for invagination and fundoplication of the stomach to the esophagus which is easy to use and which cannot be accidentally triggered. 
         [0014]    In accord with these objects which will be discussed in detail below, the endoscopic surgical instrument of the present invention includes a torsionally rigid but flexible tube having a proximal end and a distal end, a grasping and fastening end effector coupled to the distal end of the tube, and a manual actuator coupled to the proximal end of the tube. The grasping and fastening end effector preferably includes a separate grasper and a separate fastener. The manual actuator is coupled to the grasper and fastener of the end effector by a plurality of flexible cables which extend through the flexible tube. The tube preferably contains a lumen for receiving a manipulable endoscope and the end effector preferably includes a passage for the distal end of the endoscope. The end effector has a store for a plurality of male fastener parts, a store for a plurality of female fastener parts, a rotatable fastener head for aligning a male fastener part and a female fastener part with tissues therebetween, a rotatable firing member for pressing a male fastener part through the tissues and into a female fastener part, and a rotatable grasper located between the fastener head and the firing member. 
         [0015]    According to presently preferred embodiments, the overall diameters of the flexible tube and the end effector (when the fastener head is rotated to the open position and the grasper is rotated to the closed position) do not exceed approximately 20 mm (and preferably less than 16 mm) so that the instrument may be delivered transorally to the fundus of the stomach. The end effector preferably includes a substantially cylindrical stationary part which houses the store of male fastener parts and the firing member. Male fastener parts are ejected by the firing member through a substantially radial port in the substantially cylindrical stationary part of the end effector. The rotatable fastener head is hingedly coupled to a distal portion of the stationary part of the end effector and is rotatable from a first (open) position wherein the fastener head is rotated distally away from the stationary part to a second (closed) position wherein the fastener head is rotated proximally toward the stationary part. The store of female fastener parts is preferably contained within the fastener head and a female fastener shuttle on the fastener head moves a female fastener from the store into alignment with the substantially radial port when the fastener head is rotated to the closed position. 
         [0016]    The presently preferred store for male fastener parts includes a longitudinal track arranged proximally of the rotatable firing member in which male fastener parts are arranged one behind the other. Male fastener parts are moved distally along the track by a first biasing member. According to one embodiment, the firing member includes a flange which blocks distal movement of male fastener parts while a male fastener part is being ejected. According to a presently preferred embodiment, a spring leaf with a pair of bent teeth engages the distal end of the next male fastener part in the track keeping it from moving off the track. When the firing member moves down to grab another male fastener part, the leaf is deflected allowing the next male fastener part to enter the firing member. The presently preferred store for female fastener parts includes an orthogonal chamber in which female fastener parts are stacked on top of each other and a second biasing member for moving the female fastener parts onto the female fastener shuttle. The presently preferred female fastener shuttle is a sliding tray which is located adjacent to the store of female fastener parts. The second biasing member pushes female fastener parts into the tray and the tray moves laterally away from the store of female fastener parts when the rotatable fastener head is moved from the open position to the closed position. 
         [0017]    The rotatable fastener head, the firing member, and the grasper are preferably each controlled by an individual cable; and the proximal actuator includes three levers, each coupled to a respective cable, for individually operating the rotatable fastener head, the firing member, and the grasper. According to a presently preferred embodiment, the manual actuator includes a lock-out feature which prevents the inadvertent firing of male fastener members until the fastener head is rotated into the proper position. The manual actuator also includes a releasable lock for locking the grasper in the closed position. 
         [0018]    According to one embodiment, the male fastener member is a circular disk with a central upstanding barbed projection and the female fastener member is a circular disk with a central hole engageable by the barbed projection of a male fastener member. According to another, presently preferred embodiment, the female fastener is rectangular with a central hole engageable by the barbed projection of a male fastener member. The female member is preferably provided with a plurality of weak peripheral extensions which allow the member to be held in the shuttle tray, but forcibly removed therefrom after it is coupled to a male member. 
         [0019]    The apparatus of the invention is advantageously utilized in a fundoplication procedure. The instrument is prepared by inserting a manipulable endoscope into the proximal end of the instrument and threading the endoscope through the lumen of the flexible tube out through the end of the end effector. With the grasper closed and the rotatable fastener head in the first (open) position, the end effector is inserted into the mouth of the patient and guided down through the esophagus into the stomach with the aid of the endoscope. When the end effector is distal of the fundus (or lower esophageal sphincter), the grasper is opened and the end effector is raised toward the fundus so that the fundus and the lower end of the esophagus are located between the stationary part of the end effector and the grasper. The grasper is then closed to clamp together the tissue around the juncture of the esophagus and the fundus. With the grasper closed, the rotatable fastener head is closed, raising it up toward the fundus and lifting the fundus up against the esophagus. With the instrument in this configuration, the firing member is actuated and a male fastener member is ejected out of the radial port, through the esophagus and the fundus, and into a female fastener member which is held by the tray in the rotatable fastener head. The firing member is then returned to its initial position moving the flange or the leaf away from the male fastener store and allowing a second male fastener to be pushed onto the second rotatable member. The rotatable fastener head is moved to the open position, releasing the female fastener, and returning the tray to the store of female fasteners to receive a second female fastener. The grasper is opened and the instrument may then be repositioned and the above procedure repeated until the desired fundoplication is achieved. 
         [0020]    Additional objects and advantages of the invention will become apparent to those skilled in the art upon reference to the detailed description taken in conjunction with the provided figures. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0021]      FIG. 1  is an enlarged broken perspective view of a first embodiment of a flexible endoscopic surgical instrument according to the invention with the end effector in a fully open position; 
           [0022]      FIG. 2  is an enlarged broken perspective view of the distal end of the instrument of  FIG. 1  with the grasper of the end effector in a closed position; 
           [0023]      FIG. 3  is an enlarged broken perspective view of the distal end of the instrument of  FIG. 1  with the end effector in a fully closed position; 
           [0024]      FIG. 4  is an enlarged proximal end view of the end effector removed from the instrument of  FIG. 1 ; 
           [0025]      FIG. 5  is a broken enlarged transparent side elevation view of the end effector in the fully closed position; 
           [0026]      FIG. 6  is a broken enlarged transparent side elevation view of the end effector in the fully closed position with a male fastener part ejected into a female fastener part; 
           [0027]      FIG. 7  is an enlarged side elevation view of a male fastener part according to the invention; 
           [0028]      FIG. 8  is an enlarged top view of the fastener part of  FIG. 7 ; 
           [0029]      FIG. 9  is an enlarged side elevation view of a first embodiment of a female fastener part according to the invention; 
           [0030]      FIG. 10  is am enlarged top view of the fastener part of  FIG. 9 ; 
           [0031]      FIG. 11  is an enlarged schematic view of the distal end of the instrument of  FIG. 1  adjacent the gastroesophageal junction in a first operative position; 
           [0032]      FIG. 12  is a view similar to  FIG. 11  of the instrument in a second operative position; 
           [0033]      FIG. 13  is a view similar to  FIG. 11  of the instrument in a third operative position; 
           [0034]      FIG. 14  is a view similar to  FIG. 11  of the instrument in a fourth operative position; 
           [0035]      FIG. 15  is a view similar to  FIG. 11  of the instrument in a fifth operative position; 
           [0036]      FIG. 16  is a side elevation view of one side of a presently preferred manual actuator in a first operative position (grasper closed and fastener head open) with the near side of the casing removed; 
           [0037]      FIG. 17  is an isometric view of one side of the actuator of  FIG. 16  with the near side of the casing removed; 
           [0038]      FIG. 18  is a side elevational view of the other side of the actuator of  FIG. 16  with the near side of the casing removed; 
           [0039]      FIG. 19  is an isometric view of the other side of the actuator of  FIG. 16  with the near side of the casing removed; 
           [0040]      FIG. 20  is a view similar to  FIG. 16  with the actuator in a second operative position (grasper open and fastener head open); 
           [0041]      FIG. 21  is a view similar to  FIG. 16  with the actuator in the midpoint a third operative position (grasper closed and fastener head partially closed); 
           [0042]      FIG. 22  is a view similar to  FIG. 16  with the actuator in a fourth operative position (grasper closed and fastener head closed); 
           [0043]      FIG. 23  is a view similar to  FIG. 16  with the actuator in a fifth operative position (grasper closed, fastener head closed, and male fastener part fired); 
           [0044]      FIG. 24  is a view similar to  FIG. 21  of the other side of the manual actuator; 
           [0045]      FIG. 25  is a perspective view of a presently preferred embodiment of the end effector in a first operative position; 
           [0046]      FIG. 26  is a perspective view of the presently preferred embodiment of the end effector in a second operative position; 
           [0047]      FIG. 27  is a perspective view of the presently preferred embodiment of the end effector in a third operative position; 
           [0048]      FIG. 28  is a perspective view of the distal end of the presently preferred embodiment of the end effector in the third operative position; 
           [0049]      FIG. 29  is a perspective view of the proximal end of the presently preferred embodiment of the end effector in the third operative position; 
           [0050]      FIG. 30  is a perspective view of the major components of the presently preferred embodiment of the end effector in the third operative position; 
           [0051]      FIG. 31  is a perspective view of the major components of the presently preferred embodiment of the end effector in a fourth operative position; 
           [0052]      FIG. 32  is a perspective view of the stationary component and the grasper of the presently preferred embodiment of the end effector; 
           [0053]      FIG. 33  is a perspective view of the grasper component and the fastener firing component of the presently preferred embodiment of the end effector; 
           [0054]      FIG. 34  is a view similar to  FIG. 33  of the other side of the grasper component and the fastener firing component; 
           [0055]      FIG. 35  is a perspective view of the top side of a presently preferred embodiment of a female fastener part in the female fastener carrier; 
           [0056]      FIG. 36  is a perspective view of the bottom of the presently preferred female fastener part; 
           [0057]      FIG. 37  is a perspective view of the presently preferred female fastener part coupled to the male fastener part; 
           [0058]      FIG. 38  is a broken, partially cut away perspective view of an alternate preferred embodiment showing the firing member receiving a male fastener part; 
           [0059]      FIG. 39  is a view similar to  FIG. 38  from a different perspective; 
           [0060]      FIG. 40  is a view similar  FIG. 39  showing the firing member raised and the leaf preventing a male fastener part from moving off the track; 
           [0061]      FIG. 41  is a broken perspective view of the embodiment of  FIGS. 38-40  showing the end effector with the firing member with a male fastener part engaged therein; 
           [0062]      FIG. 42  is a perspective view of the firing member and male fastener part engaged therein by a leaf spring; 
           [0063]      FIG. 43  is a perspective view of the firing member with the leaf spring disengaged from the male fastener part to release the male fastener part; 
           [0064]      FIG. 44  is a perspective view showing the end effector with the firing member with a male fastener part with the leaf spring disengaged from the male fastener part to release the male fastener part; 
           [0065]      FIG. 45  is a broken, partially cut away perspective view of the embodiment of  FIGS. 38-44  showing the store of female fastener parts with a female fastener part in position to receive a male fastener part; 
           [0066]      FIG. 46  is a broken perspective view of the embodiment of  FIGS. 38-45  showing the female fastener part shuttle in position to retrieve a female fastener part from the store of female fastener parts; 
           [0067]      FIG. 47  is a broken, partially cut away perspective view of the embodiment of  FIGS. 38-46  showing the female fastener part shuttle in an intermediate position; and 
           [0068]      FIG. 48  is a broken, partially cut away perspective view of the embodiment of  FIGS. 38-47  showing the female fastener part and male fastener parts coupled with the ejector spring engaging the barb of the male fastener part. 
       
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
       [0069]    Referring now to  FIGS. 1 through 4 , a first embodiment of an endoscopic surgical instrument  10  includes a torsionally rigid but flexible tube  12 , preferably made from polyethylene, and having a proximal end  14  and a distal end  16 , a grasping and fastening end effector  18  coupled to the distal end  16  of the tube  12 , and a manual actuator  20  coupled to the proximal end  14  of the tube  12 . The manual actuator  20  is coupled to the end effector  18  by three flexible cables  22 ,  24 ,  26  which extend through the flexible tube  12 . Each of the cables is preferably formed from an outer coil sheath  22   a,    24   a,    26   a,  and an inner pull wire  22   b,    24   b,    26   b.  The actuator  20  includes three levers  22   c,    24   c,    26   c  which are coupled to respective pull wires  22   b,    24   b,    26   b.  The tube  12  also contains a lumen  28  for receiving a manipulable endoscope  2  and the end effector  18  includes a passage  30  for the distal end  4  of the endoscope  2 . Preferably, the overall diameters of the flexible tube  12  and the end effector  18  (when in the position shown in  FIG. 2 ) do not exceed approximately 20 mm (and are preferably no more than 16 mm) so that the instrument may be delivered transorally through the esophagus to the fundus of the stomach. 
         [0070]    The end effector  18  has a substantially cylindrical stationary member  31 , a rotatable fastener head  40 , and a grasper  42 . The stationary member  31  has a relatively flexible proximal portion  32  and a relatively rigid distal portion  34 . The distal portion is rigid so that a store of male fastener parts and firing member can be located therein. The length of the rigid portion depends on the number of male fastener parts desired to be stored. The distal portion  34  has a flattened part  36  which angles down toward the distal end  38  of the stationary member  31 . As will be described in more detail below with reference to  FIGS. 5 and 6 , the rotatable fastener head  40  is coupled to the distal end of the flattened portion  36  and is rotatable toward and away from the flattened portion  36  as seen best in  FIGS. 2 and 3 . The rotatable grasper  42  is coupled to the distal end of the flattened portion  36  proximal of the rotatable fastener head  40  and is rotatable toward and away from the flattened portion  36  as seen best in  FIGS. 1 and 2 . The rotatable fastener head  40  is coupled to the cable  24  so that its movement is controlled by the lever  24   c  and the grasper  42  is coupled to the cable  26  so that its movement is controlled by the lever  26   c.    
         [0071]    Referring now to  FIGS. 4-6 , the stationary member  31  of the end effector  18  includes a store  44  for male fastener parts, e.g.  46 , and a substantially radial port  48  through which male fastener parts are ejected. As will be described in more detail below with reference to  FIGS. 7 and 8 , the male fasteners have a substantially T-shaped profile and the store  44  is a substantially T-shaped track which is dimensioned to hold approximately six male fastener parts. A biasing spring  50  urges the male fasteners distally along the track into position adjacent the port  48 . A rotatable firing member  52  is located adjacent to the distal end of the track  44  and is coupled to the cable  22 . Thus, operation of the lever  22   c  ( FIG. 1 ) rotates the rotatable firing member  52  thereby ejecting a male fastener part through the port  48 . A lower flange  54  on the member  52  prevents distal movement of the fastener parts in the track  44  until the member  52  is rotated back to its original position. 
         [0072]    Referring generally to  FIGS. 1-6 , the rotatable fastener head  40  includes a store  56  for female fastener parts, e.g.  57 , and a sliding tray  58  for moving female fastener parts out of the store  56 . The sliding tray  58  is moved automatically by a wire link  60  which causes the tray to move away from the store  56  when the rotatable fastener head  40  is rotated from the open position ( FIGS. 1 and 2 ) to the closed position ( FIGS. 3-6 ). As will be described in more detail below with reference to  FIGS. 9 and 10 , according to one embodiment, the female fastener parts are generally disk shaped and are held in a stack in the store  56 . A spring  62  biases the fastener parts into the tray  58  when the rotatable fastener head  40  is in the open position. The tray  58  is dimensioned such that a single fastener part is retrieved from the stack and moved in the tray to a position opposite to the port  48  when the rotatable fastener head  40  is rotated from the open position to the closed position. 
         [0073]    Turning now to  FIGS. 7-10 , a presently preferred male fastener part  46  has a disk shaped base  46   a,  a central upstanding shaft  46   b,  and tapered barb  46   c  at the end of the shaft. According to a preferred embodiment, the base is approximately 0.3 inches in diameter and approximately 0.040 inches thick, the upstanding member is approximately 0.140 inches tall, and the barb is approximately 0.10 inches long. A first embodiment of a female fastening member  57  is a substantially flat disk  57   a,  having a central hole  57   b,  and four radially outward extending peripheral tabs  57   c - 57   f.  Four radial strain relief slits  57   g - 57   j  are preferably provided adjacent to the hole  57   b.  The female fastener is approximately 0.3 inches in diameter and approximately 0.040 inches thick. Both the male fastener and the female fastener parts are made from biocompatible polymers. The barb  46   c,  the shaft  46   b,  and the hole  57   b  are dimensioned such that the barb may be forced through the hole to lock the fastener parts together, but that once locked together, the parts will not easily separate. The peripheral tabs  57   c - 57   f  are dimensioned such that they hold the female fastener part in the sliding tray prior to being locked together with the male fastener part, but that they allow the female fastener part to be pulled out of the tray after it is locked together with the male fastener part. For example, the tabs are thin enough to bend, flex, or shear off when the female fastener part is pulled out of the tray. 
         [0074]    As mentioned above, the instrument of the invention is advantageously utilized in a fundoplication procedure. With reference now to  FIGS. 1 ,  2  and  11 - 15 , the instrument  10  is prepared by inserting a manipulable endoscope  2  into the proximal end of the instrument and threading the endoscope through the lumen of the flexible tube  12  out through the end of the end effector  18 . With the grasper  42  closed and the rotatable fastener head  40  in the first (open) position (as shown in  FIGS. 2 and 11 , the end effector  18  is inserted into the mouth of the patient and guided down through the esophagus  3  into the stomach  5  with the aid of the endoscope  2 . When the grasper  42  and the rotatable fastener head  40  are distal of the fundus  7 , the grasper  42  is opened as shown in  FIG. 12  and the end effector is raised toward the fundus  7  so that the fundus and the lower end of the esophagus  3  are located between the stationary part  31  of the end effector and the grasper  42 . The grasper  42  is closed to hold the gastroesophageal junction as shown in  FIG. 13 . The rotatable fastener head  40  is then rotated to the closed position, raising it up toward the fundus  7  and lifting the fundus  7  up against the esophagus  3  as shown in  FIG. 14 . With the instrument in this configuration, the rotatable firing member ( 52  in  FIGS. 5 and 6 ) is actuated and a male fastener member  46  is ejected out of the radial port  48 , through the esophagus  3  and the fundus  7 , and into a female fastener member  57  as shown in  FIG. 15 . The rotatable firing member is then returned to its original position, moving the flange  54  away from the male fastener store  44  and allowing a second male fastener to be pushed onto the second rotatable member  52 . The rotatable fastener head  40  is moved to the open position, releasing the female fastener, and, returning the tray to the store of female fasteners to receive a second female fastener. The grasper  42  is opened and the instrument may then be repositioned and the above procedure repeated until the desired fundoplication is achieved. 
         [0075]      FIGS. 16 through 24  show a presently preferred manual actuator  100 , according to the invention, which is provided with a lock-out feature to prevent the inadvertent firing of a male fastener member before the rotatable fastener head is in the proper position and with a lockable lever for holding the grasper in the closed position. Referring now to  FIGS. 16-20 , and as seen best in  FIGS. 17 and 19 , the actuator  100  has a generally pistol-shaped housing  101  which is formed from two mating halves  102 ,  104 . By generally pistol-shaped, it is meant that the housing has a grip portion  108  and a barrel portion  109 . Three levers ( 106 ,  118 ,  136 ) and a toothed cam ( 122 ) are rotatably mounted within the housing. 
         [0076]    The first lever  106  is mounted adjacent to the gripping portion  108  of the housing and is pivotally coupled at its upper end to the housing by a pin  110 . A slotted throughbore  112  in the lever  106  is located below the pin  110 . The slotted throughbore  112  receives the proximal end of cable  26  (which controls the grasper) and the cable is attached to the lever  106  by a crosspin  114 . The lower end of the lever  106  is provided with a spring biased latch  116  which is operatively engageable with a notch (not shown) in the housing. 
         [0077]    The second lever  118  is pivotally coupled at one end  120  to the proximal end of the toothed cam  122 . The second lever  118  is also provided with a slotted throughbore  124  which receives the proximal end of cable  22  (which controls the fastener firing member). The proximal end of the cable  22  is coupled to the lever  118  by a crosspin  126  in the slotted throughbore  124 . The slotted throughbore  124  is located in a portion  118   a  of the lever  118  which is broader than an immediately adjacent portion  118   b.  A locking stop  113  is provided in housing half  104  ( FIG. 18 ) which blocks movement of the broad portion  118   a  of the lever as described in more detail below. 
         [0078]    The toothed cam  122  is rotatably coupled to one portion  102  of the housing by a pin  128  which is located between the grip portion  108  and the barrel portion  109  of the housing. This portion of the housing is provided with a slotted wall  111  ( FIG. 16 ) through which the first and second levers  106 ,  118  exit the housing. The slot in the wall  111  is dimensioned to allow passage of the portion  118   b  of the lever  118  and may be dimensioned to prevent the passage of the broader portion  118   a.  The cam  122  has a distal curved slotted throughbore  130  which receives the proximal end of cable  24  (which controls the rotatable fastener head). The proximal end of cable  24  is coupled to the cam  122  by a crosspin  132  which rides in the curved throughbore  130 . The cam  122  is provided with a plurality of peripheral teeth  134  which extend along a curved path from the proximal end of the cam where the lever  118  is coupled to it, to a point adjacent to the curved throughbore. 
         [0079]    The third lever  136  is rotatably mounted above the cam  122  by a pin  138  and is provided with a plurality of radial teeth  140  which engage the teeth  134  of the cam  122 . 
         [0080]    The housing  101  is also provided with a plurality of cable guides  142  ( FIG. 17 ) in the barrel portion  109  of the housing half  102  and an endoscope receiving tube  144  ( FIG. 18 ) in the barrel portion  109  of the housing half  104 . In addition, the housing halves  102 ,  104  are provided with longitudinal guide slots  146 ,  148  which engage the crosspin  132  and guide its motion in a longitudinal direction. 
         [0081]    The operation of the actuator  100  is described in sequence with reference to  FIGS. 16-24  and with reference to the presently preferred end effector configuration of  FIGS. 25-31  which are discussed in more detail below.  FIGS. 16-19  show the positions of the levers  106  and  136  when the grasper is closed and the fastener head is opened (see also  FIG. 25 ). In this position of lever  136 , the lever  118  is positioned so that it is impossible to move the lever  118  to fire a male fastener. In particular, the distal location of lever  136  has caused the radial teeth  140  to rotate the cam  122  proximally which has moved the pivot point  120  of the lever  118  to a position proximal of its broad portion  118   a.  In order to move the lever  118 , the broad portion  118   a  needs to pass the stop  113  ( FIG. 18 ) which prevents its movement. In addition, since the lever  118  must rotate about the pivot point  120 , the portion  118   a  needs to exit the slot  111  in the housing. However, as described above, the slot may be dimensioned to prevent this movement. With the levers in the positions shown in  FIGS. 16-19 , the instrument is in the proper orientation for delivery through the esophagus. It will also be appreciated that the positions and locations of the levers are easy to understand and provide intuitive indication of the positions of the parts of the end effector. For example, the lever  106  is “closed” relative to the grip  108  indicating that the grasper is closed. The lever  136  is approximately 180° forward indicating that the fastener head is rotated forward (distally) approximately 180°. The lever  118 , which is most like the trigger portion of the pistol shaped actuator is raised up and out of the way where it cannot be pulled. 
         [0082]    After the end effector is in place at the surgical site, the grasper is opened (to the position shown in  FIG. 26 ) by releasing the latch  116  and moving the lever  106  distally as shown in  FIG. 20 ; thereby moving cable  26  which is attached to the grasper  206 . After the grasper has been properly positioned, the lever  106  is moved back and the latch  116  holds the grasper locked closed (in the position shown in  FIG. 25 ). 
         [0083]    The rotatable fastener head is now closed (to the position shown in  FIGS. 27-30 ) by rotating the lever  136  proximally which is shown in two stages in  FIGS. 21 and 22 . As seen in comparing  FIGS. 20 ,  21 , and  22 , as the lever  136  is rotated proximally, the teeth  140  on the lever  136  engage the teeth  134  on the cam  122  causing the cam  122  to rotate distally. This action causes the curved slot  130  to rotate in a manner which forces the cross pin  132  to move distally in the slots  146 ,  148 . Movement of the crosspin  132  moves the cable  24  distally causing the fastener head to close. At the same time, the pivot point  120  of the lever  118  is rotated above the broad portion  118   a  of the lever  118 . This moves the broad portion  118   a  above the stop  113  and places the lever  118  in a position where the broad portion  118   a  does not need to exit the slot  111  and can freely pass alongside the stop  113 . As shown in  FIG. 22 , the lever  118  is now operable to fire a male fastener. It will be appreciated that, until the fastening head is completely closed, movement of the firing lever  118  to pull the cable  22  is prevented by the stop  113 . In addition, it will be appreciated that the crosspin coupling  126  remains stationary as the cam  122  causes the lever  118  to be rotated about this pin. 
         [0084]      FIG. 23  shows the lever  118  moved to the proximal position which pulls the cable  22  proximally and fires the male fastener part (as shown in  FIG. 31 ). As seen best in  FIG. 24 , when the firing lever is in the proximal position, the stop  113  is located below the broad portion  118   a.  It will be appreciated that this position of the lever  118  will prevent the lever  136  from being moved distally. Distal movement of the lever  136  will attempt to rotate the cam  122  in a manner which will move the lever  118  in a direction where its broad portion  118   a  must pass the stop  113 . Therefore, before the lever  136  can be moved to open the fastener head, the firing lever  118  must be moved back to the position shown in  FIG. 22 . As show in  FIGS. 23 and 24 , the lever  118  is preferably concave along its proximal side so that it can be moved over the lever  106 . 
         [0085]    Turning now to  FIGS. 25-37 , the presently preferred end effector and fasteners are similar to those described above with reference to  FIGS. 1-10  with some differences which will become apparent from the following description. 
         [0086]    The end effector  200  has a substantially cylindrical stationary member  202 , a rotatable fastener head  204 , and a grasper  206 . The stationary member  202  has a relatively flexible proximal portion  208  and a relatively rigid distal portion  210 . The distal portion  210  has a flattened part  212  which angles down toward the distal end  214  of the stationary member  202 . The flattened part  212  is provided with a first grasping surface  216  and the grasper  206  is provided with a second grasping surface  218 . A male fastener exit port  220  is located intermediate of the flattened part  212  and the proximal portion  208 . As seen best in  FIGS. 30 and 31 , a firing member  222  with a movable male fastener part holder  224  is located inside the stationary member  202 . As seen best in  FIG. 29 , a store  226  of male fastener parts  227  is located inside the stationary member  202 , proximal of the firing member  222 . Individual male fastener parts  227   a  are biased from the store into the male fastener part holder  224  by a spring  229  as shown in  FIG. 30 . According to this embodiment, up to six male fastener parts are held in the store. As seen best in  FIGS. 28 and 29 , an endoscope port  228  is provided in the stationary member  222  below the male fastener part store  226 . Three cable ports  230 ,  232 ,  234  are provided in the stationary member  202  as shown in  FIG. 29  for attaching control cables to the grasper  206 , the fastener head  204 , and the firing member  222 , respectively. 
         [0087]    The rotatable fastener head  204  includes a store  236  of female fastener parts  237  and a movable tray  238  for moving female fastener parts out of the store and into position to receive a male fastener part as described below. According to this embodiment, up to six female fastener parts are held in the store. The movable tray  238  is coupled to the fastener head  204  by flanges  238   a,    238   b  which slideably engage grooves  204   a,    204   b  in the fastener head as seen best in  FIGS. 27-30 . The movable fastener head  204  is coupled to the distal end  214  of the stationary member  202  by a pivot axle  240 , and a hinged link  242  ( FIG. 28 ) couples the fastener head  204  to a control cable (not shown). When the link  242  is moved distally, the fastener head  204  is moved to the closed position as shown in  FIG. 28 . When in this position, the hinge  242   a  in the link  242  is moved past the center of the pivot axle  240  which locks the fastener head in the closed position. The sliding tray  238  is coupled via a flange  238   c  and a pivoting link  244  to the pivot axle  240  as seen best in  FIGS. 25 and 26 . This link  244  causes the tray  238  to slide from the position shown in  FIGS. 25 and 26  to the position shown in  FIGS. 27 and 28  when the fastener head  204  is closed. 
         [0088]    The firing member  222  is coupled to the stationary member  202  by the same pivot axle  240  as the fastener head as shown in  FIGS. 25 ,  26 ,  30 ,  33 , and  34 . The firing member  222  is coupled to a control cable (not shown) by a lower flange  222   a  as shown in  FIGS. 30 ,  33 , and  34 . As shown in  FIG. 32 , the distal portion  210  of the stationary member  202  is provided with a stepped port  234  through which the control cable for the firing member passes and which holds the cable sheath. When the control cable pulls the flange  222   a  proximally, the firing member  222  is moved towards the exit port  220 . The movable male fastener part holder  224  is provided with a proximal flange  224   a  which is coupled to a lateral portion  210   a  of the stationary member  202  by a pivoting link  246  as seen best in  FIG. 30 . This link  246  causes the holder  224  to slide distally as shown in  FIG. 31  when a male fastener part is fired. The purpose of the holder  224  is to prevent the male fastener part from falling out through the port  220  when the fastener head is open and to allow the firing operation to be aborted while retaining the male fastener part. 
         [0089]    As seen best in  FIGS. 33 and 34 , the grasper  206  is pivotally coupled to the distal end of the firing member  222  on a pivot axle  250 . The grasper  206  is also coupled to a control cable (not shown) via a hole  252  located above its pivot connection. As shown in  FIGS. 31 and 32 , the distal portion  210  of the stationary member  202  is provided with a stepped port  230  through which the control cable for the grasper passes and which holds the cable sheath. When the control cable is pulled proximally, the grasper is moved to the closed position shown in  FIG. 25 . 
         [0090]    Turning now to  FIGS. 35-37 , the presently preferred male fastener part  227  (substantially the same as the fastener part  46  described above) has a disk shaped base  227   a,  a central upstanding shaft  227   b,  and tapered barb  227   c  at the end of the shaft. The presently preferred female fastening member  237  is a substantially flat rectangular member  237   a  defining a central hole  237   b.  The hole  237   b  has a tapered entry  237   c  and four radial strain relief slots  237   d.  Four flexible or frangible peripheral tabs  237   e  are provided on the periphery of the rectangular member. These tabs hold the fastener part in the tray  238  as shown in  FIG. 35 , but allow it to be pulled out of the tray after it is coupled to a male fastener part as shown in  FIG. 37 . 
         [0091]    Turning now to  FIGS. 38-48 , an alternate preferred end effector  300  is similar to the end effector  200  described above, with similar reference numerals referring to similar parts. 
         [0092]    The end effector  300  has a substantially cylindrical stationary member  302 , a rotatable fastener head  304 , and a grasper  306 . The stationary member  302  has a flattened part  312  which angles down toward the distal end  314  of the stationary member  302 . The flattened part  312  is provided with a first grasping surface  316  and the grasper  306  is provided with a second grasping surface  318 . A male fastener exit port  320  is located at the proximal end of the flattened part  312 . As seen best in  FIGS. 38-44 , a firing member  322  with a male fastener part holder  324  is located inside the stationary member  302 . 
         [0093]    As seen best in  FIGS. 41-44 , the holder  324  has a pair of flanged springy arms  324   a,    324   b  which hold the base of a male fastener part, e.g.  327   a.  The arms  324   a,    324   b  are biased outward to the position shown in  FIG. 43 . As seen best in  FIGS. 41 and 44 , the interior of the stationary member  302  has contoured walls  303   a,    303   b  which hold the arms  324   a,    2324   b  close together, securing the male fastener part. When the firing member  322  is raised into the firing position, as shown in  FIGS. 40 and 44 , the springy arms  324   a,    324   b  move outward as shown in  FIG. 43 , thereby releasing the male fastener part. 
         [0094]    As seen best in  FIGS. 38-40 , a store  326  of male fastener parts  327   a,    327   b,  etc. is located inside the stationary member  302 , proximal of the firing member  322 . Individual male fastener parts  327   a,    327   b,  etc. are biased from the store into the male fastener part holder  324  by a spring (not shown). According to this embodiment, a leaf spring  325  having an upstanding flange  325   a  and a distal tongue  325   b  ( FIG. 40 ) is arranged beneath the row of male fastener parts in the store  326 . As shown in  FIG. 40 , the distal most fastener part is prevented from exiting the store  326  by the flange  325   a  when the firing member  322  is in the firing position. When the firing member  322  returns from the firing position as seen in  FIGS. 38 and 39 , the tongue  325   b  of the leaf spring is depressed by the firing member  322  and the flange  325   a  is thereby moved away from the next fastener part allowing it to enter the holder  324  of the firing member  322 . 
         [0095]    As seen best in  FIGS. 41 ,  44 , and  48 , an endoscope port  328  is provided in the stationary member  322  below the male fastener part store  326 . Three cable ports  330 ,  332 ,  334  are provided in the stationary member  302  as shown in  FIGS. 41 and 44  for attaching control cables to the grasper  306 , the fastener head  304 , and the firing member  322 , respectively. 
         [0096]    As shown in  FIGS. 41-48 , the rotatable fastener head  304  includes a store  236  of female fastener parts  337  and a movable tray  338  for moving female fastener parts out of the store and into position to receive a male fastener part as described below. According to this embodiment, up to six female fastener parts are held in the store. As seen best in  FIG. 44 , the movable tray  338  is coupled to the fastener head  304  by flanges  338   a,    338   b  which slideably engage flanges  304   a,    304   b  in the fastener head. The sliding tray  338  is coupled via a flange  338   c  and a pivoting link  344  to the pivot axle  340  as seen best in  FIGS. 44 ,  45 , and  48 . This link  344  causes the tray  338  to slide from the position shown in  FIG. 44  to the position shown in  FIGS. 45 and 48  when the fastener head  304  is closed. 
         [0097]    As seen best in  FIGS. 45-48 , the female fastener parts  337   a - 337   e  are biased out of the store  336  by a bifurcated leaf spring  305  and are held laterally in line by a support post  307  which is seen best in  FIG. 46  where the movable tray has been removed to better expose the spring  305  and the post  307 . A fastener discharge spring  309  is located adjacent to the female fastener store  336  and is provided with a male fastener engaging surface  311 . As the fastener head  304  is moved from the open position shown in  FIG. 46  to the closed position shown in  FIG. 45 , the movable tray  338  moves the top most female fastener part  337   a  out of the store and over the discharge spring  309 .  FIG. 47  shows the tray  338  in a midway position as the fastener  337   a  is being moved into position to receive a male fastener part. When a male fastener is fired into the female fastener as shown in  FIG. 48 , The end of the male fastener will engage the surface  311  on the spring  309  and compress the spring. It will be appreciated that as the firing member  322  is returned from the firing position, the spring  309  will push against the end of the male fastener thereby pushing the female fastener out of the tray, bending or breaking the tabs of the female fastener. 
         [0098]    The firing member  322  is coupled to the stationary member  302  by the same pivot axle  340  as the fastener head as shown in  FIGS. 39 ,  40 ,  42 ,  43  and  48 . The firing member  322  is coupled to a control cable (not shown) by a lower flange  322   a  as shown in  FIG. 48 . When the control cable pulls the flange  322   a  proximally, the firing member  322  is moved towards the exit port  320 . 
         [0099]    There have been described and illustrated herein several embodiments of a flexible endoscopic surgical instrument for invagination and fundoplication. While particular embodiments of the invention have been described, it is not intended that the invention be limited thereto, as it is intended that the invention be as broad in scope as the art will allow and that the specification be read likewise. It will therefore be appreciated by those skilled in the art that yet other modifications could be made to the provided invention without deviating from its spirit and scope as so claimed.