FLEXIBLE ENDOSCOPIC SURGICAL INSTRUMENT FOR INVAGINATION AND FUNDOPLATIONBACKGROUND OF THE INVENTION 1. Field of the Invention The invention relates to an endoscopic surgical instrument. More particularly, the invention relates to a flexible instrument for transoral invagination and fundoplication of the stomach into the esophagus.2. State of the art Gastroesophageal fundoplication is a procedure for the treatment of gastroesophageal reflux diseases (GERD), a condition that involves regurgitating gastric acids into the esophagus resulting in esophagitis, involuntary vomiting, asthma, and aspiration pneumonia. The fundoplication procedure involves wrapping the fundus of the stomach around the lower end of the esophagus and putting it in place. Traditionally, this procedure is carried out by open surgery with the use of suture to ensure the folded fundus of the stomach around the esophagus, without penetrating (making incisions) in the stomach.
P839 U.S. Pat. No. 5,403, 326 to Harrison et al. exposes a method to perform endoscopic fundoplication using surgical clips or two-part surgical fasteners. The procedure set forth by Harrison et al. involves making two percutaneous endoscopic gastrotomies (incisions through the skin into the stomach) and the installation of two ports through which the stapler, an endoscope and an esophageal manipulator (invagination device) are inserted. With the sight given by the endoscope, the esophageal manipulator is used to pull the inside of the esophagus into the stomach. When the esophagus is in position, with the fundus of the stomach folded, the stapler moves to its position around the lower end of the esophagus and the folded fundus is stapled with the esophagus. This process is repeated in different axial and rotary positions, until the desired fundoplication is achieved. While the procedure discovered by Harrison et al. It is a great improvement over open surgery, it is still a bit hostile since it requires two incisions through the stomach. In addition, the procedure requires two different tools in order to position the fundus and secure the fundus to the esophagus.
U.S. Patent No. 5,571, 116 to Bolanos et al. exposes a non-hostile treatment for gastroesophageal reflux disease using a remotely operated invagination device and a surgical stapler also remotely operated, both are inserted transorally through the esophagus. In accordance with the methods discovered by Bolanos et al., First, the invagination device is inserted and used to hold the gastroesophageal junction. Afterwards, the device moves distally, pulling the gastroesophageal junction fastened into the stomach, so that it invaginates the junction and wraps around the fundic wall surrounding it. Then, the stapler is inserted transorally and delivered to the invaginated junction where it is used to staple the fundal wall. Bolanos et al. exposes different invagination devices and different staplers. Generally, each of the staplers discovered by Bolanos et al. they have an elongated body and an anvil that can be rotated 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 that holds a plurality of staples and a staple trigger blade. Each of the invagination devices exposed by Bolanos et al. it has a jaw piece that can be rotated at least 45 ° and in some cases more than 90 ° to an open position to grip the gastroesophageal junction. One of the main disadvantages of the methods and apparatus discovered by Bolanos et al. is that the stapler and the invagination device must be present in the esophagus at the same time. With some of the modalities exposed, the presence of both instruments is extremely difficult because of the size of the esophagus. In all modalities, the invagination device is always laterally separated from the stapler. In this way, the stapler can not staple the invaginated tissue, per se, but can only staple tissue that is laterally adjacent to the invaginated tissue. The relatively small rotational movement of the stapler anvil also complicates the accommodation of the tissue adjacent to the invaginated tissue. In addition, surgical staples have some inherent disadvantages compared to other fasteners. The relatively small surface area of the surgical clips allows them to eventually pass through the tissue and release the tissue, allowing the staples to move to other parts of the body. It seems that Bolanos et al. recognizes this disadvantage and proposes the application of a solera or fastener for the fabrics before stapling. Bolanos et al. it does not explain how to achieve this transorally using the discovered apparatus. In addition, while Bolanos et al. makes extensive reference to other types of fasteners, the substantial size restrictions imposed on devices that are introduced transorally seems to prohibit any kind of fastener other than staples shown by Bolanos et al. The drive mechanism of the device exposed by Bolanos et al. It is a bit stupid. In particular, the anvil of the stapler is pushed into the open position and it is not clear whether the stapler anvil can be locked in a closed position without holding the lever. In addition, it appears that the staple trigger trigger may be inadvertently operated before the anvil is in its closed position. This can result in inadvertent expulsion of staples into the patient's stomach or esophagus.
SUMMARY OF THE INVENTION Therefore, an object of the invention is to provide an endoscopic surgical instrument for the intussusception and fundoplication of the stomach towards theP839 esophagus Also, another objective of the invention is to provide an endoscopic surgical instrument for the intussusception and fundoplication of the stomach into the esophagus that is very unfriendly. Another objective of the invention is to provide an endoscopic surgical instrument for the intussusception and fundoplication of the stomach into the esophagus using fasteners that do not require sills or fasteners. "Still another object of the invention is to provide an endoscopic surgical instrument for the intussusception and fundoplication of the stomach into the esophagus that is transorally introduced to the surgical site." A further objective of the invention is to provide an endoscopic surgical instrument for intussusception. and fundoplication of the stomach into the esophagus which is capable of folding tissue directly in line with the invaginated tissue.Another objective of the invention is to provide an endoscopic surgical instrument for the intussusception and fundoplication of the stomach into the esophagus that is easy to use and that is not accidentally operated In accordance with the objectives, which will be explained in detail later, the endoscopic surgical instrument of the present invention includes aP839 flexible tube, but rigid when twisted, having a proximal end and a distal end, an end effector gripper and fastener coupled to the distal end of the tube and a manual actuator coupled to the proximal end of the tube. Preferably, the end effector and gripper includes a separate gripper and a separate clip. The manual actuator is coupled to the effector gripper and holder by a plurality of flexible cables extending through the flexible tube. Preferably, the tube contains a lumen for receiving a manipulable endoscope and the effector preferably includes a passage for the distal end of the endoscope. The effector has a magazine for a plurality of male fastener parts, a magazine for a plurality of female fastener parts, a rotatable clamping head for aligning a male fastener part with a female fastener part with the fabrics therebetween, a rotary trigger member for pressing a male fastener piece through the tissues and into the female fastener part and a rotary gripper located between the head of the fastener and the trigger member. In accordance with the presently preferred embodiments, the total diameters of the flexible tube and the end effector (when the head of the holder rotates towards the open position and the holder rotates towards theclosed position) do not exceed approximately 20 mm (and preferably less than 16 mm), so that the instrument can be introduced transorally into the fundus of the stomach. The end effector, preferably, includes a substantially cylindrical stationary portion that encloses the store for the male fastener parts and the trigger member. The male fastener parts are ejected by the trigger member through the essentially radial port in the substantially cylindrical part of the end effector. The rotating clamping head is hingedly coupled to the distal portion of the stationary part of the end effector and is rotatable from a first (open) position, wherein the head of the clamper rotates distally from the stationary part, to a second position ( closed) wherein the head of the clip rotates proximally towards the stationary part. The magazine of the female fastener parts is preferably contained within the head of the fastener and a female fastener shuttle in the head of the fastener moves a female fastener from the magazine, in alignment with the substantially radial port, when the head of the holder rotates towards the closed position. The presently preferred magazine for the male fastener parts includes a rail arranged proximally to the rotary trigger member in which the male fastener parts are arranged one behind the other. The male fastener pieces move distally along the rail by a first push member. According to one embodiment, the trigger member includes a flange that blocks distal movement of the male fastener parts, while a male fastener member is ejected. According to a currently preferred embodiment, a spring leaf with a pair of bent teeth engages with the distal end of the next male fastener part in the rail, which prevents it from moving out of the rail. When the trigger member moves down to grip another male clamping member, the spring blade deflects so that it allows the next male clamping member to enter the trigger member. The presently preferred magazine for the female fastener parts includes an orthogonal chamber in which the female fastener parts are stacked one on top of the other and a second pusher member for moving the female fastener parts on the fastener shuttle. The currently preferred female fastener shuttle is a sliding tray which is located adjacent to the storage of female fastener parts. The second pusher member pushes the female fastener parts towards the tray and the tray moves laterally away from the store of the female fastener parts when the rotary fastener head moves from the open to the closed position. Preferably, the rotating clamping head, the trigger member and the gripper, each is controlled by an individual cable and the proximal actuator includes three levers, each coupled to a respective cable to operate the rotating clamping head individually, the member trigger and gripper. In accordance with a currently preferred embodiment, the manual actuator includes a safety feature that prevents inadvertent firing of the male fastener members until the head of the fastener rotates to its proper position. The manual actuator also includes a releasable latch to secure the gripper in the closed position. According to one embodiment, the male fastening member is a circular disc with a central upward spigot projection and the female fastening member is a circular disc with a central hole that can be engaged with the spiked projection of a male fastening member. In accordance with another currently preferred embodiment, the female fastener is rectangular with a central hole that can be attached to the spline projection of the male fastening member. The female member is preferably provided with a plurality of weak peripheral extensions that allow the member to be held in the shuttle tray, but can be forcefully removed from it after it has engaged with the male member. The apparatus of the invention is advantageously used in the fundoplication procedure.The instrument is prepared by inserting a manipulable endoscope into the proximal end of the instrument and by threading the endoscope through the lumen of the flexible tube out through the end of the end effector With the gripper closed and the head of the rotary holder in the first (open) position, the end effector is inserted into the patient's mouth and guided downward through the esophagus into the stomach with the endoscope aid When the end effector is away from the fundus (or lower esophageal sphincter), the gripper opens and the end effector is raised to 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 gripper., the gripper closes to hold together the tissue around the junction of the esophagus and the fundus. With the gripper closed, the rotating clamping head closes and rises to the fundus and raises the fundus up against the esophagus. With the instrument in this configuration, the trigger 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 supported by the tray in the rotary clamping head. The trigger member then returns to its initial position by moving the flange or spring blade away from the storage of male fasteners and allows the second male fastener to be pushed on the second rotating member. The swivel head is moved to the open position, releasing the female clip and returning the tray to the female clip store to receive a second female clip. The gripper opens and the instrument can be repositioned and the previous process is repeated until the desired fundoplication is achieved. Additional objects and advantages of the invention will be apparent to those skilled in the art with reference to the detailed description taken in conjunction with the accompanying Figures.
BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 is a perspective, sectional view, amplified of a first embodiment of the flexible endoscopic surgical instrument according to the invention with the end effectorP839 in a fully open position; Figure 2 is a perspective, sectional view, amplified of the distal end of the instrument of Figure 1 with the end effector gripper in a closed position; Figure 3 is a perspective, sectional view, amplified from the distal end of the instrument of Figure 1 with the end effector in a fully closed position; Figure 4 is a view of the proximal, amplified end of the end effector removed from the instrument of Figure 1; Figure 5 is a side elevational view, transparent, amplified, in section of the end effector ~ in a fully closed position; Figure 6 is a side elevation view, transparent, amplified, in section of the end effector in the fully closed position with a male clamping member extruded into a female clamping part; Figure 7 is an enlarged side elevational view of a male fastener part according to the invention; Figure 8 is a top, magnified view of the holder part of Figure 7;P839"Figure 9 is a side elevational view, amplified of a first embodiment of a female fastener part according to the invention; Figure 10 is a magnified top view of the fastener part of Figure 9; a schematic, amplified view of the distal end of the instrument of Figure 1 adjacent to the joint in a second operative position; Figure 12 is a view similar to Figure11 of the instrument in a second operative position; Figure 13 is a view similar to Figure 11 of the instrument in a third operative position; Figure 14 is a view similar to Figure 11 of the instrument in a fourth operative position; Figure 15 is a view similar to Figure 11 of the instrument in a fifth operative position; Figure 16 is a side elevational view of one side of a currently preferred manual actuator in a first operative position (closed gripper and open fastener head) with the proximal side of the box removed; Figure 17 is an isometric view of one side of the actuator of Figure 16 with the proximal side of the box removed;P839"Figure 18 is a side elevational view of another side of the actuator of Figure 16 with the proximal side of the box removed; Figure 19 is an isometric view of another side of the actuator of Figure 16 corf the proximal side of the box removed: Figure 20 is a view similar to Figure 16 with the actuator in a second operative position (open gripper and open fastener head); Figure 21 is a view similar to Figure16 with the actuator at the midpoint of a third operative position (closed gripper and partially closed fastener head); Figure 22 is a view similar to Figure 16 with the actuator in a fourth operative position (gripper closed and the head of the fastener closed); Figure 23 is a view similar to Figure 16 with the actuator in a fifth operative position (the gripper closed, the head of the fastener closed and the ejector male part ejected); Figure 24 is a view similar to Figure 21 on the other side of the manual actuator; Figure 25 is a perspective view of a currently preferred embodiment of the end effector in a first operative position;P839 Figure 26 is a perspective view of a currently preferred embodiment of the end effector in a second operative position; Figure 27 is a perspective view of a currently preferred embodiment of the end effector in a third operative position; Figure 28 is a perspective view of the distal end of a currently preferred embodiment of the end effector in the third operative position; Figure 29 is a perspective view of the proximal end of a currently preferred embodiment of the end effector in the third operative position; Figure 30 is a perspective view of the main components of a currently preferred embodiment of the end effector in the third operative position; Figure 31 is a perspective view of the principal components of a currently preferred embodiment of the end effector in a fourth operative position; Figure 32 is a perspective view of the stationary and gripper component of the currently preferred embodiment of the end effector; Figure 33 is a perspective view of the gripper component and the trigger component ofP839 fasteners of the currently preferred mode of the end effector; Figure 34 is a view similar to Figure 33 on the other side of the gripper component and fastener release component; Figure 35 is a perspective view of the upper side of a currently preferred embodiment of a female fastener part in the holder of female fasteners; Figure 36 is a perspective view of the lower part of the currently preferred female holder part; Figure 37 is a perspective view of the currently preferred female fastener part coupled to the male fastener part; Figure 38 is a perspective, partial cut, exploded view of an alternative preferred embodiment showing the trigger member receiving a male clamping member; Figure 39 is a view similar to Figure38 from a different perspective; Figure 40 is a view similar to Figure 38 showing the raised trigger member and the spring blade which prevents a male holder piece from moving out of the rail;P839 Figure 41 is an exploded perspective view of the embodiment of Figures 38-40 showing the end effector with the trigger member with a male clamping member coupled thereto; Figure 42 is a perspective view of the trigger member and the male clamping member coupled thereto by a spring blade; Figure 43 is a perspective view of the trigger member with the spring blade decoupled from the male chuck to release the male chuck; Figure 44 is a perspective view showing the end effector with the trigger member with a male clamping piece with the spring leaf decoupled from the male clamping piece to release the male clamping member; Figure 45 is a perspective exploded partial view of the embodiment shown in Figures 38-44 - showing the storage of the female fastener parts with a female fastener in position to receive a male fastener; Figure 46 is an exploded perspective view of the embodiment of Figures 38-44 showing the shuttle of the female holding part in position to retrieve a female holding part of theP839 female fastener parts warehouse; Fig. 47 is a perspective, partially cut away, exploded view of the embodiment of Figs. 38-46 showing the shuttle of the female holding member in an intermediate position; and Figure 48 is an exploded, perspective view of the embodiment shown in Figures 38-47 showing the female fastener part and the male fastener part engaged with the ejector spring coupled with the dowel of the male fastener part.
DETAILED DESCRIPTION OF THE PREFERRED MODALITIES With reference to Figures 1 to 4, the first modality of the endoscopic surgical instrument 10 is shown which includes a flexible, but rigid tube 12 when torsion is applied, preferably made of polyethylene and having an extreme14 proximal and a distal end 16, an end effector 18 and end fastener coupled with the end16 distal of the tube 12 and a manual actuator 20 coupled with the proximal end of the tube 12. The manual actuator 20 is coupled to the end effector 18 by three cables 22, 24, 26 which extend through the flexible tube 12. Each of the cablesP839 is preferably formed of a helical liner 22a, 24a, 26a and an internal tension wire 22b, 24b, 26b. The actuator 20 includes three levers 22c, 24c, 26c which are coupled to their respective tie wire 22b, 24b, 26b. The tube 12 also contains a lumen 28 for receiving an unresectable endoscope 2 and the end effector 18 includes a passage 30 for the distal end 4 of the endoscope 2. Preferably, the total diameters of the flexible tube 12 and the end effector 18 (when in the position shown in Figure 2) do not exceed approximately 20 mm (and preferably, not greater than 16 mm), so that "the instrument can be introduced transorally through the esophagus into the fundus of the stomach." The end effector 18 has a stationary cylindrical member 31, a rotary head 40 and a gripper 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 the storage of male fastener parts and a trigger member can be placed therein. it depends on the number of male fastener parts that one wishes to store The distal portion 34 has a flat part 36 that forms an angle downward towards theP839 end 38 remote from the trigger member. As will be described in detail below with reference to FIGS. 5 and 6, the rotary clamping head 40 engages the distal end of the flat portion 36 and "can rotate toward and away from the flat portion 36 as best seen in FIG. Figures 2 and 3. The rotary gripper 42 engages the distal end of the flat portion 36 close to the rotating hold head 40 and is rotatable toward and away from the flat portion 36 as best seen in Figures 1 and 2. The rotating clamping head 40 engages the cable 24 so that its movement is controlled by a lever 24c and the gripper 42 engages with the cable 26 so that its movement is controlled by the lever 26c With reference to Figs. 6, the stationary member 31 of the end effector 18 includes a magazine 44 for male fastener parts, i.e. 46, and an essentially radial port 48 through which the male fastener parts are ejected. In more detail with reference to Figures 7 and 8, the male fasteners have a practically T-shaped profile and the warehouse 44"is a substantially T-shaped rail having the dimensions to hold approximately six clamping piecesP839 male. A push spring 50 pushes the male fasteners distally along the rail in a position adjacent the port 48. A rotatable trigger member 52 is located adjacent the distal end of the rail 44 and is coupled with the cable 22. In this way, the operation of the lever 22c (Figure 1) rotates the pivoting trigger member 52 so as to eject a male clamping piece through the port 48. A lower rim 54 in the member 52 prevents distal movement of the clamping portions in the rail 44 until member 52 rotates back to its original position. Generally, with reference to Figures 1-6, the rotary head 40 includes a magazine 56 for the female fastener parts, i.e., 57, and a slide tray 58 for moving the female fastener parts out of the store 56. The sliding pan 58 it is automatically moved by a wire link 60 which causes the tray to move distally of the store 56 when the rotary head 40 rotates from the open position (Figures 1 and 2) to the closed position (Figures 3-6). As will be described in more detail, hereinafter with reference to Figures 9 and 10, in accordance with one embodiment, the female fastener parts generally have a disc shape and are kept stacked in the store 56. A spring 62 pushes the discs in the direction of the disc. fastener parts within the tray 58 when the rotary holder head 40 is in the open position. The tray 58 is dimensioned so that only one clamping piece is retrieved from the stack and moved in the tray towards a position opposite to the port 48, when the rotating clamping head 40 rotates from the open position to the closed position. Now with reference to Figures 7-10, a currently preferred male fastener piece 46 has a disc-shaped base 46a, a central splined arrow 46b, a tapered tang 46c at the end of the arrow. According to a preferred embodiment, the base is approximately 0.3 inches in diameter and approximately 0.040 inches in thickness, the erect member is approximately 0.140 inches in height and the spike is approximately 0.10 inches in length. A first embodiment of the female fastening member 57 is a substantially flat disk 57a with a central hole 57b and four peripheral fins 57c-57f extending radially outwardly. Preferably, four radial tension-relieving slots 57g-57j are provided adjacent the hole 57b. The female fastener is approximately 0.3 inches in diameter and approximately 0.40 inches in thickness. Both the male clamping piece and the female clamping piece are made of biocompatible polymers. The tang 46c, the arrow 46b and the hole 57b have the dimensions such that the pin forcibly passes through the hole to secure the clamping pieces together, but once secured, the pieces will not be easily separated. The peripheral fins 57c-57f have dimensions such that they hold the female fastener piece in the slide tray before being secured with the male fastener, but allow the female fastener piece to be pulled out of the tray after it is secured with the male clamping piece. For example, the fins are thin enough to be bent, flexed or cut when the female fastener is pulled out of the tray. As mentioned before, the instrument of the invention is used with advantages in a fundoplication process. Now, with reference to Figures 1, 2 and 11-15, the instrument 10 is prepared by inserting a manipulable endoscope 2 into the proximal end of the instrument and by threading the endoscope through the lumen of the flexible tube 12 outward through the end effector end 18. With grip 42 closedP839 the rotary clamping head 40 in the first (open) position (as shown in Figures 2 and 11), the end effector 18 is inserted into the patient's mouth and guided down through the esophagus 3 into the stomach of the patient with the aid of the endoscope 2. When the gripper 42 and the rotating holder head 40 are separated from the fundus 7, the gripper 42 opens as shown in Figure 12 and the end effector is raised to 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 gripper 42. The gripper 42 is closed to maintain the gastroesophageal junction as shown in Figure 13. The rotating head 40 rotates afterwards. towards the closed position, rising towards the fundus 7 and raising the fundus 7 against the esophagus 3 as shown in Figure 14. With the instrument in this configuration, the trigger member (52 in Figures 5 and 6) , is actuated and the male fastening member 46 is ejected outward from the radial port 48, through the esophagus 3 and the fundus 7 and into the female fastening member 57 as shown in Figure 15. The trigger member returns to its position original, moving the rim 54 distally of the male fastener store 44, allowing a secondP839 male fastener is pushed towards the second rotary member 52. The rotating holding head 40 moves towards the open position, releasing a female fastener and returning the tray to the female fastener store to receive a second female fastener. The gripper 42 is opened and the instrument can be repositioned "in position and the above procedure is repeated until the desired fundoplication is achieved." Figures 16 to 24 show a currently preferred manual actuator 100, in accordance with the invention, which it is provided with a particularity of insurance to prevent an inadvertent firing of a male fastening member before the rotary head is in the proper position and with an insurable lever for holding the gripper in the closed position With reference to Figures 16- 20, and as can best be seen in Figures 17 and 19, the actuator 100 has a gun-shaped housing 101 that is formed by matching the halves 102, 104. By the term gun shape, it is understood that the box has a gripping portion 108 and a barrel portion 109. Three levers (106, 118, 136) and a toothed cam (122) that are rotatably mounted within the housing. The lever 106 is mounted adjacent to the gripping portion 188 of the housing and is pivotally engaged to the upper end of the housing by a bolt 110. A slotted hole 112 in the lever 106 is located under the bolt 110. The slotted hole 112 receives the proximal end of the cable 26 (which controls the gripper) and the cable is attached to the lever 106 by a cross pin 114. The lower end of the lever 106 is provided with a spring-loaded padlock 116 which operatively couples with a notch (not shown) in the accommodation. The second lever 118 is pivotally coupled to an end 120 of the proximal end of the toothed cam 122. The second lever 118 is also provided with a slotted hole 124 that receives the proximal end of the cable 22 (which controls the trigger member fastener). The proximal end of the cable 22 is coupled to the lever 118 by a crosshead pin 126 in the slotted hole 124. The slotted hole 124 is located in a portion 118a of the lever 118 which is wider than the immediately adjacent portion 118b. A safety stop 113 is provided in housing half 104 (FIG. 18) that blocks movement of the wider portion 118a of the lever as described in more detail below.
P839 Toothed cam 122 is rotatably coupled to a portion 102 of the housing by a bolt 128 that is located between grip portion 108 and barrel portion 109 of the housing. This portion of the housing is provided with a slotted wall 111 (Figure 16) through which the first and second levers 106 exit from the housing., 118. The slot in the wall 111 has sufficient dimensions to allow passage of the portion 118b of the lever 118 and may have the dimension to prevent passage of the larger portion 118a. The cam 122 has a slotted, curved, distal through hole 130 which receives the proximal end of the cable 24 (which controls the rotary head). The proximal end of the cable 24 engages with the cam 122 by a crosshead pin 132 which is in the curved hole 130. The cam 122 is provided with a plurality of peripheral teeth 34 that extend along the curved path from the proximal end of the cam where the lever 118 engages thereto, to a point adjacent to the curved orifice. The third lever 136 is mounted rotatably about the cam 122 by a bolt 138 and is provided with a plurality of radial teeth 140 which engage the teeth 134 of the cam 122.
The housing 101 is also provided with a plurality of cable guides 142 (Figure 17) in the barrel portion 109 of the housing half 102 and an endoscope receiver tube 144 (Figure 18) in the barrel portion 109 of the middle 104 of the accommodation. In addition, the halves of the housing 102, 104 are provided with longitudinal guide slots 146, 148 which engage the cross pin 132 and guide its movement in a longitudinal direction. The operation of the actuator 100 is described in sequence with reference to Figures 16-24 and with reference to the currently preferred end effector configuration of Figures 25-31 which are described in more detail below. Figures 16-19 show the positions of levers 106 and 136 when the gripper is closed and the gripper head is open (see also Figure 25). In this position of the 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 the lever 136 causes the radial teeth 140 to rotate the cam 122 proximally, which moves the point 120 of the pivot of the lever 118 to a position proximal to its wider portion 118a. In order to move the lever 118, the larger portion 118aP839 needs to pass the stop 113 (Figure 18) that prevents this movement. In addition, since the lever 118 must rotate about the pivot point 120, the portion 118a needs to exit the slot 111 of the housing. However, as described above, the slot may have the dimensions to prevent this movement. With the levers in these positions, shown in Figures 16-19, the instrument is in its proper orientation for introduction through the esophagus. It can also be seen that the positions and locations of the levers are easy to understand and provide an intuitive indication of the positions of the end effector parts. For example, the lever 106 is "closed" relative to the gripper 118, which indicates that the gripper is closed. The lever 136 is approximately 180 ° forward, which indicates that the holder head rotates forward (distally) approximately 180 °. The lever 118 which closely resembles the portion of the gun-shaped actuator rises and leaves the place where it can not be pulled. After the end effector is in place at the surgical site, the gripper opens (towards the position shown in Figure 26) by releasing padlock 116 and moving lever 106 distally as shown in the Figure twenty; for theP839 both moves the cable 26 which is coupled to the gripper 206. After the gripper has been put in place, the lever 106 moves back and the padlock 116 holds the gripper closed and secured (in the position shown in FIG. Figure 25). The rotary clamping head is now closed (in the position shown in Figures 27-30) by turning lever 136 proximally, which is shown in two stages in Figures 21 and 22. As can be seen by comparing Figures 20 , 21 and 22, as the lever 136 rotates proximally, the teeth 140 of the lever 134 engage the teeth 134 of the cam 122, which causes the cam 122 to rotate distally. This action causes the curved slot 130 to rotate in a manner that forces the crosshead pin 132 to move distally of the slots 146, 148. The movement of the crosshead pin 132 moves the cable 23 distally which causes the Holding head close. At the same time, the pivot point 120 of the lever 118 rotates on the wide portion 118a of the lever 118. This moves the wide portion 118a on the stop 113 and places the lever 118 in a position, wherein the wide portion 118a it does not need to leave the slot 111 and can pass freely along the stop 113. As shown inP839 Figure 22, lever 118 is now operable to fire a male fastener. It can be seen that, until the clamping head is completely closed, the movement of the trigger lever 118 that pulls the cable 22 is prevented by the action of the stop 113. Furthermore, it can be seen that the coupling of the cross pin 126 remains stationary as the cam 122 causes the lever 118 to rotate about this pin. Figure 23 the lever 118 moved to the near position that pulls the cable 22 proximally and fires the male clamping piece (as shown in Figure 31). As can best be seen in Figure 24, when the trigger lever is in the near position, the stop 113 is located below the wide portion 118a. It can be appreciated that this position of the lever 118 will prevent the lever 136 from being moved distally. The distal movement of the lever 136 will attempt to rotate the cam 122 in a manner that will move the lever 118 in a direction where its wide portion 118a must pass the stop 113. Therefore, before the lever 136 can move to open the clamping head, the trigger lever 118 should move back to the position shown in Figure 2. As shown in Figures 23 and 24, theP839 lever 118 is preferably concave along its proximal side so that it can be moved over lever 106. With reference to Figures 25-37, the presently preferred end effector and fasteners are similar to those described above with reference to Figures 1-10 with some differences that will be evident from the following description. The end effector 200 has a substantially cylindrical stationary member 202, a rotatable clamping head 204 and a gripper 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 flat portion 212 that forms an angle downward toward the distal end 214 of the stationary member 202. The flat portion 212 is provided with a first grip surface 216 and the gripper 206 is provided with a second grip surface 218. The outlet port of the male fastener 220 is located intermediate the flat portion 212 and the proximal portion 208. As can best be seen in Figures 30 and 31, a trigger member 222 with a movable support 224 for the male chuck member is located within the stationary member 202. As can best be seen inP839 Figure 29, a magazine 226 of male fastener parts 227 is located within the stationary member 202, close to the trigger member 222. The female fastener parts 227a are pushed from the magazine into the male fastener holder 224 by a spring 229, As shown in Figure 30. According to this method, up to six male fasteners can be kept in the warehouse. As best seen in Figures 28 and 29, a port 228 for endoscope is provided in the stationary member 222 below the storage of male fastener parts 226. Three ports for cables 230, 232, 234 are provided in the stationary member 202 as shown in Figure 29 for coupling the control cables with gripper 206, gripper head 204 and trigger member 222, respectively. The rotary chuck head 204 includes a magazine 236 for the female chucks 237 and the movable pan 238 for moving the female chucks away from the magazine to the position for receiving a chuck member, as described below. According to this method, up to six female fasteners can be kept inside the warehouse. The mobile tray 238 is coupled to the gripper head 204 by the shoulders 238a, 238b which areP839 slidably engage the slots 204a, 204b in the holding head as best seen in Figures 27-30. The movable holding head 204 is engaged with the distal end 214 of the stationary member 202 by a pivot shaft 240 and an articulated link 242 (FIG. 28) engages the fastener head 204 toward a control cable (not shown). When the link 242 moves distally, the clamping head 204 moves towards a closed position, as can be seen in Figure 28. When in this position, the joint 242a in the link 242 moves beyond the center of the axis 240 of the pivot that secures the head In the closed position, the slide tray 238 is coupled by a ridge 238c and a pivot link 244_ to the pivot shaft 240, as can be seen in Figures 25 and 26. This link 244 causes the tray 238 to slide from the position shown in Figures 25 and 26 towards the position shown in Figures 27 and 28, when the clamping head 204 is closed.The trigger member 222 is engaged with the stationary member 202 by the same pivot shaft 240 as the clamping head. , as shown in Figures 25, 26, 30, 33 and 34. The trigger member 222P839 is coupled to a control cable (not shown) by a lower flange 222a as shown in Figures 30, 33 and 34. As shown in Figure 32, the distal portion 210 of the stationary member 202 is provided with a port. step 234 through which the control cable for the trigger member passes and holds the cable liner. When the control cable pulls the flange 222a distally, the trigger member 222 moves toward the exit port 220. The male fastener holder 224 is provided with a proximal flange 224a that engages a side portion 210a of the stationary member 202 by a pivot link 246 as best seen in Figure 30. This link 246 causes the holder 224 Slide in the distal direction as shown in Figure 31, when a male clamping piece is fired. The purpose of the bra 224 is to prevent the male clamping piece from falling out of the port 220 when the clamping head opens and also allows the firing operation to be interrupted while retaining the male clamping piece. As best seen in Figures 33 and 34, the gripper 206 is pivotally engaged to the distal end of the trigger member 222 on a pivot shaft 250. The gripper 206 also engages a control cable (not shown) through the hole 252 located on its pivot connection. As shown in Figures 31 and 32, the distal portion 210 of the trigger member 202 is provided with a scaled port 230 through which the control cable for the gripper passes and which holds the cable liner. When the control cable is pulled distally, the gripper moves to the closed position shown in Figure 25. With reference to Figures 35-37, the currently preferred male clamping part 227 (substantially the same clamping piece 46 described above ) has a disc-shaped base 227a, a central spike arrow 227b and a tapered spike 227c at the end of the arrow. The presently preferred female fastener part 237 is a substantially flat rectangular member 237 defining a central hole 237b. The hole 237b has a tapered inlet 237c and four radial tension relief slots 237d. The four flexible or fracturable peripheral fins 237e are provided on the periphery of the rectangular member. These fins hold the clamping piece on the tray 238 as shown in Figure 35, but allow it to be pulled out of the tray after it is attached to a male clamping piece, as shown in FIG.
P839 Figure 37. With reference to Figures 38-48, an alternative, preferred end effector 300 is similar to the end effector 200 described above. The same reference numbers are used to indicate the same parts. The end effector 300 has a substantially cylindrical stationary member 302, a rotatable clamping head 304 and a gripper 306. The stationary member 302 has a flat portion 312 that forms a downward angle with the distal end 314 of the stationary member 302. The part 312 flat is provided with a first grip surface 316 and gripper 306 is provided with a second grip surface 318. A male fastener outlet port 320 is located at the proximal end of the flat part 312. As best seen in Figures 38-44, a trigger member 322 with a male fastener holder bracket 324 is located within the trigger member 302. As best seen in Figures 41-44, the bra 324 has a pair of flanged elastic arms 324a, 324b that hold the base of a male fastener part, i.e. 327a. The arms 324a, 324b are pushed towards the outward position shown in Figure 43. As best seen in Figures 41 and 44, the interior of the stationary member 302 has contour walls 303a, 303b that hold the arms 324a, 324b closed and thus securing the male clamping piece. When the trigger member 322 is raised to the firing position as shown in Figures 40 and 44, the spring arms 324a, 324b move outwardly as shown in Figure 43, so that the male gripper is released. As can best be seen in Figures 38-40, a store 326 of male fastener parts 327a, 327b, etc. it is located within the stationary member 302 proximal to the trigger member 322. The individual male fastener parts 327a, 327b etc., are pushed out of the magazine within the holder bracket 324 by a spring (not shown). According to this embodiment, a spring sheet 325 with an upright flange 325a and a remote tab 325b (Figure 49) is arranged below the row of male fastener parts in the warehouse 326. As shown in Figure 40, it is prevented that the most distal holder piece leaves the store 326 by the shoulder 325a, when the trigger member 322 is in the firing position. When the trigger member 322 returns from the firing position as seen in Figures 38 and 39, the tab leaf 325b of the leaf spring is depressed by theP839 trigger member 322 and flange 325a, thereby move distally of the next holder piece, allowing the holder 324 of trigger member 322 to enter. As can best be seen in Figures 41,44 and 48, a port for endoscope 328 is provided in the stationary member 322 below the magazine 326 of the male clamping member. Three cable ports 330, 332, 334 are provided in the stationary member 302 as shown in Figures 41 and 44 for coupling the control cables with the gripper 306, the gripper head 304 and the trigger member 322, respectively. As shown in Figures 41-48, the rotary chuck head 304 includes a magazine 236 of female chucks 337 and a movable chuck 338 for moving the female chucks out of the magazine to the position for receiving a male chuck, as shown in FIG. describe later. In accordance with this modality, up to six female fastener parts can be stored. As can be seen in Figure 44, the movable tray 338 is coupled to the fastening head 304 by the flanges 338a, 338b that engage slidably with the flanges 304a, 304b in the fastening head. Slip pan 338 is engaged by a flange 338c and a pivot link 344 with pivot shaft 340 as best seen in Figures 44, 45 and 48. This link 344 causes pan 338 to slide from the position shown in Figure 44 towards the position shown in Figures 45 and 48, when the holding head 304 is closed. As can be seen minor in Figures 45-48, the female fastener parts 337a-337b are pushed out of the warehouse 336 by a bifurcated spring leaf spring 305 and held laterally in line by a support post 307 that can be seen in Figure 46, wherein the movable tray has been removed to better expose the spring 305 and the post 307. A fastener discharge spring 309 is located adjacent the female fastener store 336 and is provided with a fastener engagement surface 311. male. As the clamping head 304 moves from the open position shown in Figure 46, to the closed position shown in Figure 45, the moving tray 338 moves up to the highest female clamping piece 337a out of the magazine and onto the spring 309 of discharge. Figure 47 shows the tray 338 in a middle position as the fastener 337a moves towards its position to receive a pieceP839 male fastener. When a male clip is fired into the female clip as shown in Figure 48, the end of the male clip will engage the surface 311 on the spring 309 and compress the spring. It can be seen that as the trigger member 322 returns from the firing position, the spring 309 will push against the end of the male fastener so that it pushes the female fastener out of the tray, bending or breaking the fins of the female fastener. The trigger member engages the stationary member 302 by the same pivot shaft 340 as well as the clamping head as shown in Figures 39, 40, 42, 43 and 48. The trigger member 322 is coupled to a cable control (not shown) by a lower flange 322a shown in Figure 48. When the control cable pulls the proximal flange 322a, the trigger member 322 moves toward the exit port 320. Some embodiments of the surgical instrument have been described and illustrated. endoscopic flexible for intussusception and fundoplication While the particular embodiments of the invention have been described, it is intended that the invention be as broad in scope as the technique allows and that the specification should be read in the same manner. For theP839 Thus, it can be appreciated that those skilled in the art can make other modifications to add them to the invention, without deviating from the spirit and scope of the claims.
P839