Patent Abstract:
A full-thickness resection system comprises a flexible endoscope and a stapling mechanism, wherein the endoscope is slidably received through at least a portion of the stapling mechanism. The stapling mechanism comprises an anvil and a stapling head mounted to the anvil so that the anvil and the stapling head are moveable with respect to one another between a tissue receiving position and a stapling position and wherein a gap formed between the stapling head and the anvil is larger in the tissue receiving position than it is in the stapling position. A position adjusting mechanism is provided for moving the anvil and the stapling head between the tissue receiving and stapling positions and a staple firing mechanism sequentially fires a plurality of staples from the stapling head across the gap against the anvil and through any tissue received in the gap and a knife cuts a portion of tissue received within the gap. A control unit which remains outside the body is coupled to the stapling mechanism for controlling operation of the position adjusting mechanism and the staple firing mechanism.

Full Description:
The present application is a continuation of application Ser. No. 09/813,944, filed Mar. 22, 2001, entitled “Method and Device for Full Thickness Resectioning of an Organ,” now U.S. Pat. No. 6,343,731, which is a continuation of application Ser. No. 09/694,894 filed on Oct. 25, 2000, entitled Method and Device for Full Thickness Resectioning of an Organ, now U.S. Pat. No. 6,241,140. 
    
    
     FIELD OF THE INVENTION 
     The present invention relates to full thickness resection devices for performing localized resections of lesions in tubular organs, particularly the colon. 
     BACKGROUND INFORMATION 
     A resection procedure involves excising a portion of an organ, approximating the surrounding tissue together to close up the hole created by the excision, and removing the excess tissue. Various conventional devices and procedures are available for resectioning lesions in tubular organs. 
     For example, several known resection devices and procedures requires at least one incision in an area near the portion of the organ to be excised for access to the lesion or treatment site (because, for example, the resectioning device may lack steering and/or viewing capabilities). Thus, the incision is required to allow the physician to access the organ section to be excised and guide the device to that section. Alternatively, when the organ section to be excised is beyond the reach of the surgical device, or the surgical device is not flexible enough to wind through the organ to the site to be excised, an incision will be required to position the device for the procedure. Of course, these incisions are painful and may involve a partial or entire loss of mobility while recuperating from the incision, in addition to recovering from the tubular resectioning procedure itself. In addition, the time required to recover from such a procedure is often longer than for procedures which do not require incisions. 
     One type of conventional resection procedure utilizes a circular stapling instrument in which a tubular section of a tubular organ is excised, resulting in the tubular organ being separated into a first segment and a second segment. The end sections of the first and second segments are then individually tied in a purse-string fashion, approximated, stapled, and the “purse-stringed” end sections are then cut off. In this full circle resectioning procedure, at least one separate invasive incision must be made near the section to be excised in order to cut and individually tie the separate end sections of the organ. Also, a separate incision is necessary to place one part of the resectioning device in the first segment and a corresponding second part of the device in the second segment so that the device can then bring the first and second segments together to re-attach the organ sections back together. A first of these separate parts may generally include a staple firing mechanism while the second part includes an anvil for forming the staples. Thus, this type of resectioning procedure involves the drawbacks mentioned above in regard to procedures requiring invasive incisions. In addition, the separation of the organ into two segments creates the risk of spillage of non-sterile bowel contents into the sterile body cavity, which can cause severe infection and possibly death. 
     An alternative resectioning device includes a stapling and cutting assembly on a shaft which can be bent or formed into a desired shape and then inserted into a patient&#39;s body cavity. Once the shaft has been bent into the desired shape, the rigidity of the shaft ensures that that shape is maintained throughout the operation. This arrangement limits the effective operating range of the device as the bending of the shaft into the desired shape before insertion and the rigidity of the shaft once bent require the physician to ascertain the location of the organ section to be removed before insertion, and deform the shaft accordingly. Furthermore, the rigidity of the shaft makes it difficult to reach remote areas in the organ - particularly those areas which must be reached by a winding and/or circuitous route (e.g., sigmoid colon). Thus, an incision may be required near the organ section to be excised in order to position the device at the organ section to be excised. 
     SUMMARY OF THE INVENTION 
     The present invention is directed to a full-thickness resection system comprising a flexible endoscope and a stapling mechanism, wherein the endoscope is slidably received through at least a portion of the stapling mechanism. The stapling mechanism includes an anvil and a stapling head mounted to the anvil so that the anvil and the stapling head are moveable with respect to one another between a tissue receiving position and a stapling position and wherein a gap formed between the stapling head and the anvil is larger in the tissue receiving position than it is in the stapling position. A position adjusting mechanism is provided for moving the anvil and the stapling head between the tissue receiving and stapling positions and a staple firing mechanism sequentially fires a plurality of staples from the stapling head across the gap against the anvil and through any tissue received in the gap and a knife cuts a portion of tissue received within the gap. A control unit which remains outside the body is coupled to the stapling mechanism for controlling operation of the position adjusting mechanism and the staple firing mechanism. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     FIG. 1 shows a device according to a first embodiment of the present invention; 
     FIG. 2 shows the device of FIG. 1 mounted on a conventional endoscope; 
     FIG. 3 shows the device of FIG. 1 with a grasper mechanism extending therefrom; 
     FIG. 4 shows a cutaway of the device of FIG. 1 showing a drive mechanism thereof; 
     FIG. 5 shows a cutaway of the device of FIG. 1 showing an actuating mechanism; 
     FIG. 6 shows a detailed view of the wedge used in the actuating mechanism of FIG. 1; 
     FIG. 7 shows a cut-away view of a working head assembly of the device of FIG. 1; 
     FIG. 8 shows a rear cover plate of the working head assembly of FIG. 7; 
     FIG. 9 a  shows a mechanism for restricting motion of a drive shaft of the device of FIG. 1; 
     FIG. 9 b  shows a first coupling arrangement for a drive cable and a drive shaft in the device of FIG. 1; 
     FIG. 9 c  shows a second coupling arrangement for the drive cable and the drive shaft in the device of FIG. 1; 
     FIG. 9 d  shows a perspective cut-away view of a sheath of the device of FIG. 1; 
     FIG. 10 a  shows a perspective view of an alternative construction of the wedge of FIG. 6; 
     FIG. 10 b  shows a cut-away view of the wedge of FIG. 10 a;    
     FIG. 10 c  shows a blade portion corresponding to the wedge of FIG. 10 a;    
     FIG. 11 shows a device according to a second embodiment of the present invention; 
     FIG. 12 shows a device according to a third embodiment of the present invention; 
     FIG. 13 shows a device according to a fourth embodiment of the present invention; 
     FIG. 14 a  shows a device according to a fifth embodiment of the present invention; 
     FIG. 14 b  shows a detailed cut-away view of the device of FIG. 14 a  and a conventional endoscope; 
     FIG. 15 shows a control handle for use with the devices according to the present invention; 
     FIG. 16 shows a blade housing arrangement for use with a device according to the present invention; 
     FIG. 17 shows a first arrangement of a blade shield for use with a device according to the present invention; 
     FIG. 18 shows a second arrangement of the blade shield for use with a device according to the present invention; 
     FIG. 19 a  shows a third arrangement of the blade shield for use with a device according to the present invention; 
     FIG. 19 b  shows a tissue blocker of the blade shield of FIG. 19 a;    
     FIG. 19 c  shows a distal end of a proximal housing of the device of FIG. 19 a ; and 
     FIG. 20 shows a device according to a sixth embodiment of the present invention. 
     FIG. 21 shows a device according to a seventh embodiment of the present invention. 
     FIG. 22 shows a first perspective view of the device of FIG.  21 . 
     FIG. 23 shows a second perspective view of the device of FIG.  21 . 
     FIG. 23 a  shows a third perspective view of the device of FIG.  21 . 
     FIG. 24 shows a side cut-away view of the device of FIG.  21 . 
     FIG. 25 shows a fourth perspective view of the device of FIG.  21 . 
     FIG. 26 shows a cut-away view of an exemplary stapler member of the device of FIG.  1 . 
    
    
     DETAILED DESCRIPTION 
     As shown in FIGS. 1 and 2, an apparatus according to a first embodiment of the present invention comprises a working head assembly  2  which may preferably be connected to a distal end  4   a  of a sheath  4 . The proximal end  4   b  of the sheath  4  may preferably be connected to a control handle  6 . 
     In operation, the entire apparatus is mounted onto an endoscope  8  by passing the endoscope  8  through the control handle  6 , the sheath  4 , and the working head assembly  2 , as shown in FIG.  2 . The endoscope  8  is then inserted into a body orifice to locate a lesion in the tubular organ under visual observation (usually while insufflating the organ). Once the lesion has been located, the working head assembly  2  and the sheath  4  are slidably advanced along the endoscope  8  into the tubular organ until the working head assembly  2  is in a desired position adjacent to the lesion. Those skilled in the art will understand that in an alternative embodiment, the working head assembly  2  may also be detachably coupled to a distal end of the endoscope  8 , and the entire arrangement may then be inserted into the body orifice under visual observation. 
     As shown in FIG. 1, the working head assembly  2  comprises an anvil member  10  coupled to a distal end  12   a  of a proximal housing  12 . The anvil member  10  has a substantially crescent-shaped cross-section (i.e., the outer edge  18  of the anvil member  10  substantially forms a portion of a first circle with a second smaller circular cut-out  13  formed within the first circle) with a proximal face  14  and a smaller distal face  16 . The cut-out  13  of the anvil member  10  is included to allow the endoscope  8  to be slid through the entire working head assembly  2  so that the endoscope  8  may be advanced into the body passage allowing the working head assembly  2  to later be advanced into the body to the lesion. In addition, the cut-out  13  also provides forward vision via the endoscope  8 . Thus, any shape of the cut-out  13  may be selected which is large enough to accommodate the endoscope  8 , with a larger cut-out providing a larger field of vision. An outer surface  18  of the anvil member  10  extends substantially parallel to a central axis of the working head assembly  2  while the proximal and distal faces  14 ,  18  of the anvil member  10  extend in planes substantially perpendicular to the central axis. The outer surface  18  is joined to the distal face  16  by a tapered portion  5 . 
     As shown in FIG. 3, the proximal face  14  of the anvil member  10  includes a first cavity  37  and a rim  41  encircling the first cavity  37 . A plurality of staple-forming grooves  19  are arranged in two offset rows on the rim  41  of the anvil member  10  and a circular guiding slit  21  extends radially within the rows of grooves  19 . The rim  41  protrudes from the remainder of the proximal face  14  so that a shallow cavity is formed on the proximal face  14 . 
     The anvil member  10  is coupled to the proximal housing  12  by means of two mounting shafts  20   a  and  20   b , which may preferably be substantially cylindrical. Each mounting shaft  20   a ,  20   b  is coupled to the proximal face  14  of the anvil member  10  on a respective one of two horns  22   a ,  22   b  formed by the crescent-shaped anvil member  10 . Although the anvil member  10  is shown fixedly coupled to the mounting shafts  20   a ,  20   b , those skilled in the art will understand that the anvil member  10  may also be pivotally coupled to the mounting shafts  20   a ,  20   b  in order to provide a greater field of vision through the endoscope  8  as shown in FIG. 3 a . In this pivoted-type arrangement, the anvil member  10  is angled in a first configuration so that the horns  22   a ,  22   b  are closer to the distal end  12   a  of the proximal housing than the rest of the anvil member  10 . Then, as the anvil member  10  is drawn towards the distal end  12   a  of the proximal housing  12 , the anvil member  10  would be pressed against the distal end  12   a  beginning with the horns  22   a ,  22   b , which would cause the anvil member  10  to pivot until the proximal face  14  of the anvil member  10  is parallel to the distal end  12   a.    
     As shown in FIG. 1, the mounting shafts  20   a ,  20   b  are slidably received in mounting holes  26   a ,  26   b , which have a size and shape substantially corresponding to the size and shape of the mounting shafts  20   a ,  20   b  and which run axially through the proximal housing  12 . The mounting shafts  20   a ,  20   b  are preferably movable axially proximally and distally within the mounting holes  26   a ,  26   b  between a proximal most position in which a tissue gripping gap of a first predetermined width is formed between the rim  41  and the distal end  12   a  of the proximal housing  12 , and a distal most position in which a tissue receiving gap of a larger second predetermined width is formed between the rim  41  and the distal end  12   a  of the proximal housing  12 . The second predetermined width should preferably be more than twice the thickness of a wall of the organ being resectioned so that a section of the tubular organ may be pulled into a resectioning position between the anvil member  10  and the proximal housing  12 . 
     As shown in FIG. 4, the proximal end of at least one of the mounting shafts  20   a  and  20   b  is coupled to a drive mechanism  102  provided within the proximal housing  12 . 
     In a preferred embodiment, the drive mechanism  102  is composed of a yoke  103  and a drive shaft  105 . The yoke  103  is preferably slidably received within the proximal housing  12  for longitudinal movement along the axis of the proximal housing  12  so that, when the anvil member  10  is in the proximal most position, the yoke  103  is in a corresponding proximal most position and, when the anvil member is in the distal most position, the yoke  103  is in a corresponding distal most position. 
     The yoke  103  may preferably be substantially semicircular with a substantially rectangular cross-section. Although the semicircle formed by the yoke  103  in FIG. 4 forms substantially a quarter arc of a circle, the yoke  103  may form a larger semicircle based upon the interior accommodations of the proximal housing  12  and the position of the mounting shafts  20   a ,  20   b . The mounting shaft  20   a  may preferably be coupled to the yoke  103  at a first end  103   a  of the yoke  103 , and the mounting shaft  20   b  may be coupled at a second end  103   b  of the yoke  103 . A shaft hole  107 , having a diameter substantially corresponding to a diameter of a complementarily threaded distal end  105   a  of the drive shaft  105 , extends through the yoke  103  at a point substantially midway between the first end  103   a  and second end  103   b . Thus, when the drive shaft  105  is rotated, the threaded distal end  105   a  engages the shaft hole  107  to move the yoke  103  proximally or distally (in dependence upon the direction of rotation of the drive shaft  105 ). 
     The distal end  105   a  of the drive shaft  105  should preferably be threaded over a first section  105   t  substantially corresponding in length to at least the distance between the proximal and distal most yoke positions, while a remainder portion  105   r  may have no threads thereon. The drive shaft  105  may have an increased cross-section in the areas immediately adjacent to the threaded first section lost (proximally and/or distally of section  105   t ), thereby limiting the movement of the yoke  103  to the first section  105   t . Those skilled in the art will understand that the drive shaft  105  is preferably rotatably mounted within the proximal housing  12  so that it may only rotated and may not move relative to the proximal housing  12 . The drive shaft  105  preferably extends to a proximal end  105   b  which is coupled to a drive cable  100  which extends to the control handle  6  through the sheath  4 . The drive cable  100  may preferably run axially along the peripheral interior of the sheath  4 . Those skilled in the art will understand that the sheath  4  is preferably torsionally stiff to resist the torque forces from the drive cables rotating therein. However, the sheath  4  is longitudinally flexible to so that it may be slidably advanced along the endoscope  8 , while minimizing interference with the operation of the endoscope  8  and trauma to surrounding tissue. The sheath  4  is preferably constructed similar to known endoscope insertion tubes, which are flexible yet allow the transfer of forces to swivel the distal end of the endoscope  8  in multiple directions nd the torqueable rotation of the endoscope. 
     FIGS. 7-10 show a cutaway view of the working head assembly  2  in FIG. 1, in which the respective movements of the drive shaft  105  and the yoke  103  are restricted in the manner described above. As shown in FIG. 8, a pear-shaped rear cover plate  460  may preferably be connected to the proximal end  12   b  of the proximal housing  12 . A first shaft hole  462  having a cross-sectional size substantially corresponding to the cross-sectional size of the drive shaft  105  is provided in a lower portion of the rear cover plate  460  for receiving the drive shaft  105  therethrough. Thus, the yoke  103  is restricted to only longitudinal movement in this arrangement because, the distal side of the yoke  103  is coupled to the mounting shafts  20   a ,  20   b  which are disposed in the mounting holes  26   a ,  26   b , and the proximal side of the yoke  103  is coupled to the drive shaft  105  which is disposed in the first shaft hole  462 . 
     As shown in FIG. 9 a , the movement of the drive shaft  105  may be restricted to only rotation movement about its axis by two washer-type devices  470  fixedly attached to the drive shaft  105  on either side of the rear cover plate  460 . A similar result may be achieved by providing the drive shaft  105  with a larger cross-sectional size on either side of the rear cover plate  460  in relation to the portion of the drive shaft  105  within the rear cover plate  460 . Alternatively, the cross-section of a bulging portion  476  of the drive shaft  105  located substantially in the center of the rear cover plate  460  may be larger than the portions of the drive shaft  105  immediately adjacent to the bulging portion  476 . The first shaft hole  462  may then have a center portion  474  with a larger cross-section than the rest of the first shaft hole  462  to accommodate the bulging portion  476  of the drive shaft  105 . 
     FIG. 9 b  shows a coupling arrangement between the drive cable  100  and the drive shaft  105  in which a proximal end  105   a  of the shaft may have a D-shaped hole  105   h  extending therethrough. A distal end  102   b  of the drive cable  100  has a D-shape corresponding to the shape of the hole  105   h  so that the distal end  102   b  of the drive cable may be received within the hole  105   h  in the drive shaft  105 . FIG. 9 c  shows an alternative coupling arrangement for coupling the drive cable  100  to the drive shaft  105  in which the hole  105   h  in the proximal end  105   a  of the drive shaft  105   a  and the distal end  102   b  of the drive cable  100  have corresponding squarish shapes. The single edge provided by the D-shapes in FIG. 9 b  and the four edges provided by the squarish shapes in FIG. 9 c  allow the drive cable  100  to transfer a rotational force to the drive shaft  105  with minimal slippage. 
     In operation, the user advances the endoscope  8 , with the working head assembly  2  received therearound, to a portion of tissue to be resectioned until the working head assembly  2  is in a desired position adjacent to the tissue to be resectioned. The user may then apply a force to the control handle  6  to rotate the drive cable  100  which in turn rotates the drive shaft  105  to advance the yoke  103  and the anvil member  10  distally away from the distal end  12   a  of the proximal housing  12 . As shown in FIG. 3 when the anvil member  10  has reached the distal most position, a known grasping device  108  is advanced through the sheath  4  and through the working head assembly  2  to enter the gap between the anvil member  10  and the distal end  12   a  via one of the grasper holes  32  and  33 . Although the device in FIG. 3 is shown using a duodenoscope as the endoscope  8 , those skilled in the art will understand that other types of endoscopes may also be used, such as, for example, gastroscope, colonoscope, etc. 
     A shown in FIG. 1, at least the distal end  12   a  of the proximal housing  12  preferably has a cross-section corresponding in size and shape to the proximal face  14  is of the anvil member  10 , including a cut-out  29  substantially corresponding in size and shape to the cut-out  13  of anvil member  10 . The cut-out  29  is provided to receive the endoscope  8  therein and allow the proximal housing  12  to be slidably advanced along the endoscope  8 . Of course, those skilled in the art will understand that the shape of the outer surface of the working head assembly  2  may be selected in order to accommodate various desired resectioning shapes, and the shape of the anvil member  10  may preferably be selected to form a continuous surface when positioned adjacent to the proximal housing  12  to facilitate advancing the working head assembly to into and removing it from, body passages. It is preferable that the working head assembly have a maximum diameter at any point between 15 mm and 40 mm. 
     A tissue receiving cavity  30  is formed substantially centrally in the distal end  12   a  of the proximal housing  12  to facilitate the drawing of sections of tubular organs into the gap between the anvil member  10  and the distal end  12   a . Those skilled in the art will understand that the depth of the cavity  30  may vary depending on the amount of tissue to be pulled into the cavity  30  and the size of the proximal housing  12 . Two grasper holes  32  and  33  extend axially, preferably slightly off-center from the longitudinal axis of the proximal housing  12 . 
     In a preferred embodiment, the grasper holes  32  and  33  may each preferably receive a grasping device  108  advanced from the control handle  6 , through the sheath  4 , and through a respective one of the grasper holes  32  and  33 . 
     In operation, either one or two grasping devices  108  may then be used to pull a section of the tubular organ between the anvil member  10  and the distal end  12   a  of the proximal housing  12  and into the cavity  30 . A third grasping device  108  may also be inserted through the working channel of the endoscope  8  to provide another means of positioning the organ section between the anvil member  10  and the proximal housing  12 . Of course, those skilled in the art will understand that any desired instrument may be advanced to the gap between the anvil member  10  and the distal end  12   a  through any of the grasper holes  32 ,  33  and the working channel of the endoscope  8 . 
     A plurality of staple slits  34  are preferably disposed in two offset substantially circular rows extending along the periphery of the distal end  12   a  of the proximal housing  12 . The staple slits  34  extend from an area adjacent to the mounting shaft  26   a  to an area adjacent to the other mounting shaft  26   b . The plurality of staple slits  34  may preferably be arranged so that when the anvil member  10  is in the proximal most position, each of the staple slits  34  is aligned with a corresponding one of the staple-forming grooves  19 . 
     When the device is configured for operation, a plurality of staples is received within the working head assembly  2  with each of the staples being aligned with a respective one of the staple slits  34 . The staples are then sequentially fired from the respective staple slits  34  by an actuating mechanism  104  (shown in FIG. 5) disposed in the proximal housing  12 . 
     A substantially circular blade slit  36  extends substantially radially within the staple slits  34  so that, when the anvil is in the proximal most position, the blade slit  36  is aligned with the guiding slit  21  on the anvil member. As shown more clearly in FIG. 12, extensions  84   a  and  84   b  of the blade slit  36  extend into blade housings  74   a  and  74   b , respectively, which project distally from the distal end  12   a  of proximal housing  12 . The blade housings  74   a  and  74   b  are preferably situated so that when the anvil member  10  is in its proximal most position, the blade housings  74   a  and  74   b  contact portions  43   a  and  43   b  of the rim  41  of the anvil member  10 . The extension of the blade housings  74   a  and  74   b  from the proximal housing  12  is preferably selected so that when the blade housing devices  74   a  and  74   b  engage the remainder portions  43   a  and  43   b  of the rim  41  (thereby stopping a proximal movement of the anvil member  10  and defining the proximal most position thereof), a gap is formed between the anvil member  10  and the distal end  12   a  of a length sufficient to allow the anvil member  10  to securely hold a portion of the organ against the proximal housing  12  without crushing and damaging the portion of the organ. 
     When positioned at one end of the blade slit  36  (i.e., in one of the extensions  84   a  and  84   b ), a cutting blade  202  is preferably completely enclosed within the respective one of the blade housing devices  74   a  and  74   b  and the guiding slit  21 , so that the cutting blade  202  does not cut any tissue until the physician intentionally operates the blade  202 . When the physician operates the blade  202 , the blade  202  is driven from its initial position received within one of the extensions  84   a  and  84   b  around the blade slit  36  with its cutting edge facing a direction of movement, until the blade  202  is received into the other one of the extensions  84   a  and  84   b . Thus, after a cutting operation has been performed, the blade  202  is once again prevented from inadvertently injuring the patient. 
     FIG. 6 shows a wedge  402 , a first portion  402   a  of which is non-rotatably coupled to an actuating shaft  400  so that rotation of the shaft  400  the wedge  402  rotates, preferably about the longitudinal axis of the working head assembly  2 . The wedge  402  includes a blade handle  408  which extends from a first portion  408   a  coupled to the wedge  402  to a second portion  408   b  which is coupled to the blade  202  so that, when the wedge  402  is rotated, the blade  202  is rotated through the blade slit  36 . The wedge  402  has a substantially bell-like cross-section when viewed axially, with a second portion  402   b  extending radially outward from the first portion  402   a  and, consequently, from the longitudinal axis of the shaft  400  which preferably coincides with the longitudinal axis of the working head assembly  2 . A notch of varying depth is cut out of a radially outer portion of the second portion  402   b  to form a cam surface  412  thereon. A first ramp section  412   a  ramps up from a leading face  402   d  of the wedge  402  to adjoin a second ramp section  412   b  that ramps down to adjoin a rear face  402   e  of the wedge  402 . The wedge  402  is preferably arranged in the proximal housing  12  so that the cam surface  412  is substantially aligned with the staple slits  34 . 
     A staple driver  472  extends substantially longitudinally, proximally from each of the staple slits  34  having toward the plane in which the wedge  402  rotates and each staple driver  472  is slidably received within the working head assembly  2  for motion between a distal most, staple driving position and a proximal most inoperative position. In the inoperative position, an upper end of each of the staple drivers  472  is completely received within the proximal housing  12 , just proximal of a respective staple. The staple drivers  472  are preferably substantially rectangular in shape, although bottom edges  472   a  thereof may more preferably be rounded. The length of the staple drivers  472  is preferably selected so that, in the inoperative position, the bottom surfaces  472   a  extend into the plane of rotation of the wedge between the proximal and distal most extents of the first ramp portion  412   a . The bottom surfaces  472   a  are, in the inoperative position, more preferably substantially aligned with the distal most projection of the of the cam surface  412  at the leading face  402   d.    
     Thus in operation, the wedge  402  is rotated by the actuating shaft  400  so that the first ramp section  412   a  of the cam surface  412  successively drives each of the staple drivers  472  into contact with a corresponding staple so that each staple driver  472  and its staple are driven distally through a respective one of the staple slits  34 . This drives the staples across the gap from the distal end  12   a  into the anvil member  10 , through any tissue held between the anvil member  10  and the proximal housing  12 , and into the corresponding staple forming grooves  19 . Thus the section of the tissue gripped between the anvil member  10  and the proximal housing  12  is stapled in a pattern substantially the same as that formed by the staple slits  34  (i.e., substantially circular). At the same time, the blade  202  is rotated through the blade slit  36  to cut the tissue which has just been stapled through the rotation of the wedge  402 . 
     After each of the plurality of staples has been fired, the wedge  402  may be driven in a reverse direction to reload a new plurality of staples. The wedge  402  may rotate in a direction opposite the staple firing direction without getting caught on any of the staple drivers  472  because the staple drivers are pushed out of the way by the second ramp section  412   b  of the cam surface  412 . 
     In operation, the user applies a force to the control handle  6  to rotate an actuating cable  450  about its longitudinal axis. This rotational force is transferred to the actuating shaft  400 , which then rotates the wedge  402  around the longitudinal axis of the actuating cable  450 . The first ramp section  412   a  of the cam surface  412  of the wedge  402  then individually drives the staple drivers  472  distally as described above to staple the tissue received between the anvil member  10  and the proximal housing  12  with the cutting blade  202  lagging behind the firing of the stapling since the blade handle  408  is coupled to the rear face  402   e  of the wedge. 
     FIG. 10 a  shows an alternative configuration of the wedge  402  of FIG. 6 including a separate blade portion  420 . The blade portion  420  is preferably rotatably coupled to the distal end  400   a  of the actuating shaft  400  so that a rotation of the actuating shaft  400  about its longitudinal axis does not cause a corresponding rotation of the blade portion  420 . As in FIG. 6, the wedge  202  of this apparatus is non-rotatably coupled to the distal end  400   a  of the shaft  400 . 
     The blade handle  408  of this apparatus, which is coupled to a peripheral edge  420   e  of the blade portion  420 , extends to the cutting portion of the blade  202 . As described above, the cutting portion of the blade  202  extends past the distal end  12   a  except when the blade  202  is received within one of the extensions  84   a  and  84   b.    
     The wedge  402  substantially corresponds in shape and size to the wedge  402  of FIG. 6, except that the blade handle  408  is not coupled thereto. In addition, a locking shaft  402   h  extends into a distal surface  402   t  located as shown in FIG. 10 a  so that when the blade portion  420  and the wedge portion  410  are aligned, the locking shaft  402   h  and a locking dimple  414  (shown in FIG. 10 c ) on the bottom face  420   b  of the blade portion  420  are substantially aligned. As shown in FIG. 10 b , a spring  416  is received within the locking shaft  402   h  with a proximal end of the spring coupled to the proximal end of the locking shaft  402   h . A locking ball  418  coupled to the distal end  416   b  of the spring  416  is sized so that when a proximally directed force is applied to the locking ball  418 , the locking ball  418  may be slidably received within the locking shaft  402   h . In addition, when no distally directed force is applied to the locking ball  418 , the spring  416  preferably extends so that approximately one half (or more) of the locking ball  418  extends distally out of the locking shaft  402   h . Thus, when the wedge  402  is rotated toward the blade portion  420 , the locking ball  418  is received in a cut-out  425  formed on the proximal surface  420   b  of the blade portion  420 . As shown in FIG. 10 c , the cut-out  425  slopes downward to adjoin the locking dimple  424  so that when the locking ball  418  is received, the slope of the cut-out  425  gradually pushes the locking ball  418  into the locking shaft  420   h . Then, when the wedge  402  moves into alignment with the blade portion  420 , the locking ball  418  extends out of the locking shaft  402   h  and enters the locking dimple  414  to couple the wedge  402  to the blade portion  420  so that a rotation of the wedge  402  causes a corresponding rotation of the blade portion  420 . 
     A radial length B 1  between the peripheral edge  420   e  of the blade portion  420  and the actuating shaft  400  may substantially correspond to a radial length W 1  between the wall  402   f  of the wedge portion  410  and the actuating shaft. This places the blade handle  408  in substantially the same position, relative to the cam surface  402   c  of the wedge portion  410 , as in the previous embodiments. Of course, those skilled in the art will understand that it is important that the blade  408  should extend substantially distally to the blade slit  36  so that rotation of the blade portion  420  will cause a corresponding rotation of the blade  202  through the blade slit  36 . 
     In operation, the wedge  402  is initially situated distally of one of the blade housings, e.g.,  74   a  while the blade portion  420  is situated distally of the blade housing  74   b  with the blade  202  received in the blade housing  74   b . When the lesion tissue has been drawn into position between the distal end  12   a  and the anvil member  10 , the physician actuates the shaft  400  by applying a force at the control handle  6 . This causes the wedge portion  410  to rotate distally of the staple slits  34 , to sequentially drive each of the staple drivers  472  distally through the corresponding staple slit  34 . When the wedge  402  has rotated fully into alignment with the blade portion  420  and the locking ball  418  is received into the locking dimple  414 , the operator then operates the control handle  6  in the opposite direction to draw the blade  202  out of the blade housing  74   b  to cut all of the tissue extending radially inward of the rows of staples. When the blade  202  is received in the other blade housing  74   a , the wall of the body passage is released and the lesion tissue remains within the gap between the distal end  12   a  and the anvil member  10  held by the grasping devices  108 . The lesion tissue may then be withdrawn from the body for analysis. This embodiment of the wedge  402  provides a safeguard in case the stapling process must be prematurely aborted due to, for example, a jam in one of the staple slits  34 . Using this embodiment, the cutting process is not begun until all of the staples have been fired. Thus, it is possible to reduce the risk of cutting an opening in-an organ which is not completely closed by the staples. 
     As shown in FIG. 5, the actuating mechanism  104  includes the actuating cable  450  which extends from a proximal end  450   a  coupled to the control handle  6  to a is distal end  450   b  coupled to the proximal end  400   a  of the actuating shaft  400 . Those skilled in the art will understand that the wedge  402  should preferably be situated towards the distal end  12   a  of the proximal housing  12  so that the yoke  103  does not interfere with rotation of the wedge  402  around the longitudinal axis of the actuating shaft  400  (discussed below) even when the yoke  103  is in its distal most position. 
     As shown in FIGS. 7-9 a , the rear cover plate  460  may preferably be coupled to the proximal end  12   b  of the proximal housing  12 . The proximal end  12   b  of the proximal housing  12  is then connected to the sheath  4 . The actuating shaft  400  may preferably extend through a second shaft hole  464  formed in the rear cover plate  460  of the proximal housing  12  and preferably abuts an interior portion of the cavity  30  provided on the proximal housing  12 . An endoscope hole  466  may preferably be provided on a portion of the rear cover plate  460  radially separated from the longitudinal axis of the working head assembly  2  to guide the endoscope  8  into the cut-out  29  of the proximal housing  12 . The endoscope  8  may preferably be received into the endoscope hole  466  from an endoscope lumen  40  provided within the sheath  4  which is preferably disposed along a periphery of the sheath. 
     FIG. 9 d  shows a perspective cut-away view of the sheath  4  with the various devices (i.e., the two grasping devices  108 , the drive cable  100 , the actuating cable  450 , and the endoscope  8 ) extending therethrough. Each of the various devices are further enclosed by one of a plurality of tubes  510  which allow either a rotational movement (for the cables  100 ,  450 ) or a longitudinal (for the two grasping devices  108  and the endoscope  8 ) movement therein. Similar to the sheath  4 , the plurality of tubes extend from a proximal end coupled to the control handle  6 , to a distal end coupled to the working head assembly  2 . The plurality of tubes  510  provide protection against damage due to, for example, abrasion, and provide an isolated path through the sheath  4  which prevents tangling between the various devices. 
     FIG. 18 shows a cross-section of the control handle  6  which may be used in conjunction with a resectioning device of the invention. The control handle  6  may preferably be substantially “Y” shaped, with a first branch  500  for operating the actuating mechanism  104  and a second branch  502  for operating the drive mechanism  102  and a body  520 . A receiving hole  512  runs longitudinally through the center of the body  520  for receiving the endoscope  8  therethrough. A first force transferring mechanism  504  is coupled to an actuating control knob  508 , and extends axially through the first branch  500 , through the body  520 , where it is coupled to the actuating cable  450  which extends through the sheath  4  to connect to the actuating mechanism  104 . A second force transferring mechanism  506  is coupled to a drive control knob  510 , and extends axially through the second branch  502 , through the body  520 , where it is coupled to the drive cable  100  which extends through the sheath  4  to the drive mechanism  102 . Those skilled in the art will understand that the control handle may be designed in any variety of shapes to accommodate, for example, different hand sizes, comfort, etc. In addition, different force transferring methods may also be used instead of a knob such as, for example, actuating levers, etc. 
     In operation, the user applies a rotational force to one of the control knobs  508  and  510 , the rotational force is transferred through a respective one of the force transferring mechanisms  504  and  506  which then transfers rotational force to a respective one of the drive cable  100  and actuating cable  450 , thereby operating the actuating mechanism  104  or the drive mechanism  102  as described above. 
     FIG. 11 shows a device according to a second embodiment of the present invention in which like reference numerals identify the same elements. 
     The anvil member  10  of this embodiment preferably has a substantially circular or elliptical cross-section and is gradually tapered from the proximal face  14  to its distal end  16 , forming a bullet-like structure. This tapered shape allows the device to be more easily inserted into the patient&#39;s body as the distal end  16  has a smaller cross-sectional size than in the first embodiment. Those skilled in the art will understand that the anvil member  10  may have other tapered shapes besides a bullet-like structure without departing from the scope of the present invention. 
     Instead of providing the cut-out  13  shown in the first embodiment to receive the endoscope  8  therein, a substantially cylindrical first endoscope lumen  13  extends axially through the center of the anvil member  10 . The distal end  16  of the anvil member  10  may preferably have a beveled edge  54  adjoining the first endoscope lumen  13  to allow for an expanded field of forward vision via the endoscope B. 
     The proximal housing  12  may preferably have a cross-section corresponding in size and shape to the cross-section of the proximal face  14  of the anvil member  10  (i.e., substantially circular or elliptical). In this embodiment, the cavity  30  in the first embodiment has been omitted and a substantially cylindrical second endoscope lumen  52  extends axially through the center of the proximal housing  12 . 
     However, as in the previous embodiment, two grasper holes  32 ,  33  extend axially through the proximal housing. 
     The two grasper holes  32  and  33  may preferably be disposed between the mounting holes  26   a  and  26   b  since the first endoscope lumen  13  now extends through the axial center of the proximal housing  12 . In addition, the grasper holes  32 ,  33  in this embodiment may preferably have a substantially circular cross-section. However, those skilled in the art will understand that the cross-sectional shape of the grasper holes  32  and  33  may be selected to, for example, accommodate another type of device. 
     A receiving sleeve  55  is provided on the proximal end  12   b  of the proximal housing  12  for receiving the endoscope  8  and for guiding the endoscope  8  into the proximal housing  12 . The receiving sleeve  55  may preferably have a first section  56  and a second section  58 . The first section  56  and second section  58  may preferably both have an annular cross-section forming a continuous center hole  59  therethrough. The center hole  59  has a diameter which preferably corresponds to the diameter of the receiving hole  52  so that the endoscope  8  may be continuously received through the center hole  59  into the second endoscope lumen  52  in the proximal housing  12 . The second section  58  preferably has a thicker wall than the first section  56 , such that an annular ring formed by the cross-section of the second sections  58  has a larger width than an annular ring formed by the cross-section of the first section  56 . 
     In contrast to the endoscope lumen  40  disposed along the periphery of the sheath  4  as shown in FIG. 1, the endoscope lumen  40  in this embodiment preferably runs along an axial center of the sheath  4 , so that when the sheath  4  is coupled to the working head assembly  2 , a substantially continuously aligned path is formed through the center hole  59 , through the second endoscope lumen  52 , and through the first endoscope lumen  13 . The actuating shafts  400  and  105  and the drive cables  450  and  102  are then located concentric to the endoscope lumen  40  in the sheath  4 . 
     FIG. 12 shows a device according to a third embodiment of the present invention. The proximal face  14  of the anvil member  10  of this embodiment has a cross-section similar to the crescent-shaped cross-section of the anvil member  10  of the device of FIG.  1 . Thus, the anvil member  10  has two horns  22   a  and  22   b  formed on either side of a cut-out  13  which extends axially through the anvil member  10  from the proximal face  14  to the distal end  15  to receive the endoscope  8  therein. As with the device of FIG. 11, the cross-sectional size of the anvil member  10  diminishes in overall size from a maximum at the proximal face  14  to a minimum size at the distal end  15 , and the horns  22   a  and  22   b  become less pronounced from the proximal face  14  to the distal end  15 . In a side view, the anvil member  10  becomes gradually tapered from the proximal end  14  to the distal end  16 . 
     As in the device of FIG. 11, the tapered shape of the anvil member  10  of the device of FIG. 12 allows for easier insertion of the device into the patient&#39;s body. In contrast to the second embodiment, the cut-out  13  provides a larger field of vision via the endoscope  8  as the anvil member does not totally enclose the cut-out  13 . And, as in the first embodiment, two substantially cylindrical mounting shafts  20   a  and  20   b  are coupled to the proximal face  14  of the anvil member  10  on horns  22   a  and  22   b  and are received within the mounting holes  26   a  and  26   b , respectively. 
     In contrast to the previous embodiments, the proximal housing  12  in this embodiment may preferably have a substantially oval cross-sectional shape. This shape of the proximal housing  12  is formed by extending the proximal housing  12  shown in FIG. 1 around the cut-out  29  to create the substantially cylindrical second endoscope lumen  52 . The oval shape allows the second endoscope lumen  52  to be offset from the axial center of the proximal housing  12  and aligned with the first endoscope lumen  13 . This offset of the second lumen  52  allows the cavity  30  to be provided adjoining the blade slit  36 . In all other material respects, the proximal housing  12  in this embodiment is substantially identical to the proximal housing  12  illustrated in FIG.  1 . 
     FIG. 13 shows a device according to a fourth embodiment of the present invention. This embodiment is substantially similar to the embodiment shown in FIG.  12 . However, the proximal face  14  of the anvil member  10  in this embodiment has a substantially oval-shaped cross-section corresponding to the proximal housing  12 . The anvil member  10  is tapered towards the distal end  16  to form a substantially bullet-like structure having an oval-shaped cross-section. The cut-out  13  shown in FIG. 12 may preferably be enclosed within the anvil member  10  and thereby forms an extension of the first endoscope lumen  13 . 
     A substantially semicircular shield  31  extends from the proximal face  14  of the anvil member  10  and shields a hemispherical portion of the gap formed between the anvil member  10  and the proximal housing  12 . The shield  31  allows a tissue section to be drawn primarily in the gap between the staple-forming grooves  19  and the staple slits  34  with minimal spill-over into the rest of the gap. 
     A recessed groove  35  may preferably be formed around a portion of the proximal housing  12  for slidably receiving the shield  31  therein. The recessed groove  35  may preferably have a size and shape substantially corresponding to the size and shape of the shield  31  so that when the anvil member  10  is in its proximal most position, the shield  31  is received within the recessed groove  35  to form a substantially completely continuous outer surface of the proximal housing  12 . 
     In operation, the user may utilize suction through the endoscope  8  to draw a tissue section into the gap between the anvil member  10  and the proximal housing  12 . In such a situation, the shield  31  prevents a portion of the tissue section or loose debris from being pulled into the area around the mounting shafts  20   a  and  20   b  which may otherwise interfere with the axial movement of the mounting shafts  20   a ,  20   b . In addition, the shield  31  also serves to direct the pulling force of the suction to pull tissue primarily in the gap between the staple-forming grooves  19  and the staple slits  34 . 
     FIGS. 14 a  and  14   b  show a device according to a fifth embodiment of the present invention in which the working head assembly  2  is coupled to the endoscope  8  without the sheath  4 . As described above, distal ends  500   a  of control cables  500  (i.e., drive cable  100  and actuating cable  450 ) may preferably be coupled to the working head assembly  2  while proximal ends  500   b  of the control cables  500  are coupled to the control handle  6  as in the previous embodiments. However, instead of using a flexible sheath  4  to receive the control cables  500  and the endoscope  8 , the control cables  500  are inserted into respective tubes  510 . Each of the tubes  510  should have a sufficient cross-section to allow the control cables  500  to rotate within the tubes  510 . The tubes  510  are then fastened at various predetermined points along their lengths to the endoscope  8  by a plurality of fasteners  502 . Those skilled in the art will understand that many different types of fasteners may be used either alone or in combination for this purpose so long as the fasteners do not impede the steering of the endoscope  8  or the rotation of the cables  500 . Those skilled in the art will understand that tape (e.g., surgical, electrical, etc.), electrical cable, rubber bands, other belt-style fasteners, etc. may be used as fasteners. 
     FIGS. 16-18 illustrate alternative configurations of the blade housing  74   b  and it will be understood that similar alternative embodiments may be implemented for the blade housing  74   a.    
     The blade slit  36  continues through the blade housing  74   b  into housing porion  84   b  which extends from a forward end at which the blade slit  36  enters the blade housing  74   b  to a rearward end where the blade slit  36  and the housing portion  84   b  terminate. A shield receiving slit  480  extends through the blade housing  74   b  substantially perpendicular to the housing portion  84   b  between the forward and rearward ends thereof. 
     After an organ section has been stapled between the anvil member  10  and the proximal housing  12 , and the blade  202  is drawn through the stapled tissue, there may be a problem if tissue stretches along with the blade  202  into the housing portion  84   b  without being completely severed. Withdrawal of the resectioned tissue might then lead to tearing of the tissue which is to remain in place. 
     As seen in FIG. 17, a flexible breakaway shield  482  having a shape and size substantially corresponding to the shape and size of the shield receiving slit  480  is inserted into the shield receiving slit  480 . After entering the housing portion  84   b , the cutting blade  202  contacts the shield  482  and further progress of the blade  202  deforms the shield  482  until the shield  482  is cut in half. When the shield  482  is cut in half, each half snaps back pulling the tissue in a direction opposite the direction of travel of the blade allowing the cutting blade  202  to completely sever the tissue. 
     FIG. 18 shows a second alternative arrangement in which a flexible gate  484 , having a first gate half  484   a  and a second gate half  484   b , may be removably or fixedly mounted within the shield receiving slit  480 . Each of the halves  484   a  and  484   b  may preferably be mounted within a respective half of the shield receiving slit  480 , so that a small gap formed therebetween substantially corresponds in width to the width of the cutting blade  202 . The wiping action in a direction opposed to the direction of travel of the blade  202  is substantially the same as that of the shield  482  without requiring the severing and replacement of the shield  482  after each use. 
     FIGS. 19 a  and  19   b  show a third alternative arrangement in which a pair of tissue blockers  600  and  602  facilitate the cutting of the resectioned tissue. Although, the following discussion will focus on the first tissue blocker  600 , those skilled in the art will understand that a similar arrangement may be provided on the second tissue blocker  602 . 
     As shown in FIG. 19 a , the first tissue blocker  600  is composed of a first rectangular bar  610  and a second rectangular bar  612  situated at a first end  21   a  of the guiding slit  21 . The first rectangular bar  610  has a first base  610   a  and the second rectangular bar  612  has a second base  612   a , which are both fixedly coupled to the proximal face  14  of the anvil member  10  and arranged so that the bases  610   a ,  612   b  straddle both sides of the guiding slit  21  with a gap formed therebetween corresponding to the width of the guiding slit  21 . 
     A first slot  614   a  is provided in the first base  610   a  of the first rectangular bar  610 , and a second slot  614   b  is provided in the second base  612   a  of the second rectangular bar  612  so that when the rectangular bars  610 ,  612  are coupled to the anvil member  10 , the flexible breakaway shield  482  (shown in FIG. 17) may be disposed within the slots  614   a ,  614   b . As shown in FIG. 19 c , a pair of L-shaped holes  620 ,  622  are provided on both ends of the blade slit  30  on the distal end  12   a  of the proximal housing  12 . The L-shaped holes  620 ,  622  extend longitudinally within the proximal housing  12  to receive the rectangular bars  610 ,  612  therein when the anvil member  10  is coupled to the proximal housing  12 . 
     This arrangement operates similarly to the arrangement shown in FIG. 17, so that the wiping action of the shield  482  in a direction opposite to a movement of the blade  202  allows the blade  202  to completely cut through the resectioned tissue. Although the shield  482  is initially a single piece in a first operation of the device, the shield  482  may be re-used without replacement in further operations with minimal diminishment of its effectiveness. 
     FIG. 20 shows a device according to a sixth embodiment of the present invention in which like reference numerals identify the same elements. The sheath  4  is substantially more rigid and shorter than in previous embodiments. Although this decreases the effective operative range of the device, the rigidity of the sheath  4  increases its overall structural strength, allowing greater forces to be transferred therethrough to the working head assembly  2  than in the previous embodiments. The cables  100 ,  450  driving the various mechanisms  102 ,  104  may then need to be stronger and stiffer in order to accommodate the increased forces. As a result of these changes, the overall size of the working head assembly  2  may then be increased to, for example, treat lesions that may be too large for the devices according to the previous embodiments to treat in a single procedure. 
     FIGS. 21-25 show a device according to a seventh embodiment of the present invention in which the working head assembly  2  comprises the anvil member  10 , a stapler member  17 , and a connecting adapter  25 . As shown in FIG. 21, the anvil member  10  and the stapler member  17  preferably have substantially semi-circular shapes complementary to one another such that, when they are positioned adjacent to each other, they form a substantially annular clamp-like device (as shown in FIG.  23 ). The anvil member  10  and the stapler member  17  are pivotally connected via a substantially cylindrical hinge-pin  60  which is provided on a distal end  25   a  of the connecting adapter  25 . A proximal end  25   b  of the connecting adapter  25  may preferably be coupled to the sheath  4  in a manner similar to that in which the proximal housing  12  is connected to the sheath  4  in the previous embodiments. Those skilled in the art will understand that the shape of the anvil member  10  and the stapler member  17  may be modified to accommodate specific needs or applications without departing from the scope of the present invention. 
     As shown in FIG. 22, a plurality of first ring-like extensions lob are formed on a first end  10   a  of the anvil member  10 . The first extensions  10   b  may preferably be separated a predetermined distance from one another to form a plurality of spaces in which a corresponding plurality of second ring-like extensions  17   b  formed on a first end  17   a  of the stapler member  17  are accommodated. 
     The first extensions  10   b  may substantially correspond in shape and size to the second ring-like extensions  17   b  so that when the first anvil end  10   a  and the first stapler end  17   a  are engaged, an alternating arrangement of first and second extensions  10   b ,  17   b  is formed in which the holes of each of the first and second extensions  10   b ,  17   b  are substantially aligned to form a continuous hole in which a hinge-pin  60  is received. Thus, the hinge-pin  60  and the first and second extensions  10   b ,  17   b  form a hinge which allows the anvil member  10  and the stapler member  17  to pivot about the hinge-pin  60 . A locking ring  62  may preferably be attached to a distal end  61  of the hinge-pin  60  to secure the first and second extensions  10   b ,  17   b  to the hinge-pin  60 . 
     A first anchoring joint  23   a  is formed on an interior face  10   i  of the anvil member  10 . The first anchoring joint  23   a  may preferably have a substantially triangular cross-section viewed along the longitudinal axis of the working head assembly  2 . However, a side of the first anchoring joint  23   a  that is attached to the anvil member  10  may preferably be convex in shape complementary to the concave shape of the interior face  10   i  of the anvil member  10 . A substantially similar second anchoring joint  23   b  is formed on an interior face  17   i  of the stapler member  17  having a size and shape corresponding to the size and shape of the anchoring joint  23   a.    
     As shown in FIG. 23, first and second coupling elements  64   a ,  64   b  are disposed on respective anchoring joints  23   a ,  23   b  to couple the anchoring joints  23   a ,  23   b  to two rod links  150   a ,  150   b , respectively. The rod links  150   a ,  150   b  provide a rigid coupling between the anchoring joints  23   a ,  23   b  and a distal end  154  of a push rod  152 . Thus, a longitudinal force in a distal or proximal direction applied to the push rod  152  is transferred to the anchoring joints  23   a ,  23   b , and thereby to the anvil member  10  and the stapler member  17 . 
     In operation, when a distally directed pushing force is applied to the push rod  152 , the force is transferred through the link rods  150   a ,  150   b  to the anvil member  10  and the stapler member  17  via the respective anchoring joints  23   a ,  23   b , gradually separating an anvil head  10   c  on the anvil member  10  from a stapler head  17   c  on the stapler member  17  until they reach a tissue receiving position. Similarly, when a proximally directed pulling force is applied to the push rod  152 , the anvil head  10   c  and the stapler head  17   c  are drawn toward one another until they reach a stapling position, in which the anvil head  10   c  and the stapler head  17   c  are adjacent to one another separated by a narrow gap. As the anvil head  10   c  and the staler head  17   c  are drawn together by the push rod  152 , a stabilizer tongue  308  extending from the stapler head  17   c  of the stapler member  17  is gradually received within a stabilizing groove  304  on the anvil is head  10   c . This tongue/groove arrangement provides a guide and a securing/stabilization mechanism for the anvil member  10  and the stapling member  17 . 
     The anvil head  10   c  is disposed on a second end  10   e  of the anvil member  10  that is opposite to the first end  10   a  thereof. The anvil head  10 c may preferably have a substantially rectangular cross-section larger than a cross-sectional size of the rest of the anvil member  10 . The anvil head  10   c  has an anvil face  10   d  on which a plurality of staple-forming grooves  19  may preferably be arranged in two offset, substantially straight lines. In addition, a substantially straight guiding slit  21  may preferably extend substantially along the center of the anvil face  10   d , substantially parallel to the lines of staple-forming grooves  19 , while the stabilizing groove  304  is preferably formed along a distal side of the anvil face  10   d  for receiving the stabilizer tongue  308 . The stabilizing groove  304  may preferably have a shape and size substantially corresponding to the stabilizing tongue  308  so that the stabilizing tongue  308  is snugly received within the stabilizing groove  304  when the anvil member  10  and the stapler member  17  are in the stapling position. 
     As shown in FIG. 23 a , the stapler head  17   c  is formed on a second end  17   e  of the stapler member  17  opposite to the first end  17   a  thereof, and preferably has a cross-section corresponding, at least in the area adjacent to a stapler face  17   d , to the size and shape of the anvil head  10   c . A plurality of staple slits  34  are arranged on the stapler face  17   d  in positions corresponding to the position of the staple-forming grooves  19  on the anvil head  10   c  so that when the stapler face  17   d  and anvil face  10   d  are positioned adjacent to each other, each of the plurality of staple slits  34  is substantially aligned with a corresponding one of the plurality of staple-forming groove  19 . Additionally, a substantially straight blade slit  36  extends across the stapler face  17   d  corresponding to the guiding slit  21  on the anvil head  10   c  so that when the stapler head  17   c  and the anvil head  10   c  are positioned adjacent to one another, the blade slit  36  is substantially aligned with the guiding slit  21 . 
     As shown in FIG. 23, the distal end  25   a  of the connecting adapter  25  preferably has a cross-section corresponding to the shape and size of the peripheral surface of the annular clamp-like shape formed by the anvil member  10  and the stapler member  17  so that a substantially smooth, continuous outer surface is formed by the anvil member  10 , the stapler member  17 , and the connecting adapter  25  when the anvil member  10  and the stapler member  17  are in the stapling position. The connecting adapter  25  is preferably gradually tapered from the distal end  25   a  to the proximal end  25   b  thereof, and the proximal end  25   b  may then. be coupled to the sheath  4  as shown in FIG.  24 . As further shown in FIG. 24, a substantially cylindrical endoscope lumen  52  preferably extends axially through the center of the connecting adapter  25  for receiving a conventional endoscope  8  therethrough. The connecting adapter  25  may also have a substantially cylindrical rod hole  322  extending axially along the periphery of the connecting adapter  25  extending through an area adjacent to the hinge-pin  60 , for receiving the push rod  152  therein. 
     As shown in the cut-away view of FIG. 25, a track  350  is provided within the stapler head  17   c  extending within the stapler head  17   c  from an area adjacent to a distal end  352  of the stapler head  17   c  to an area adjacent to a proximal end  354  thereof. FIG. 26 shows a cutaway view of the stapler head  17   c  showing the track  350  having a substantially L-shaped cross-section. The track  350  may preferably be situated so that a first leg  350   a  of the track  350  extends substantially beneath the plurality of staple slits  34  on the staple face  17   d , and a second leg  350   b  of the track  350  extends substantially beneath the blade slit  21  on the staple face  17   d.    
     In a first configuration shown in FIG. 25, a wedge-sled  402  is provided (instead of the wedge  402  described in the previous embodiments) on a distal end  350   a  of the track  350 . The wedge-sled  402  has a cut-out in a corner forming a cam surface  412  thereon and a blade handle  408 . This provides the wedge-sled  402  with a substantially L-shaped cross-section substantially corresponding to the cross-sectional shape of the track  350 . The wedge-sled  402  is arranged in the track  350  so that the cam surface  412  is substantially disposed in the first leg  350   a  of the track facing toward the plurality of staple slits  34 . Furthermore, the wedge-sled  402  is arranged in the track  350  so that the blade handle  408  is subsantially disposed in the second leg  350   b  beneath the blade slit  21 . Thus, when the cutting blade  202  is coupled to the blade handle  408 , the cutting blade  202  extends out of the blade slit  21  as in the previous embodiments. As shown in FIG. 26, the stabilizing tongue  308  has a receiving slit  309  for receiving the cutting blade  202  therein when the wedge-sled  402  is positioned at the distal end  350   a  of the track  350 . This prevents unintentional cutting of tissue as the device is inserted and guided within the organ. 
     As shown in FIG. 25, an actuating cable  450  for operating the stapler head  17   c  is coupled to the leading edge  402   d  of the wedge-sled  402  and extends through the track  350 , through a tube  332  (which is coupled to the proximal end  354  of the stapler head  17   c  and extends through the sheath  4  to the control handle) of the plurality of tubes  510  (shown in FIG. 9 d ), and is then coupled to the control handle  6  (not shown). 
     In operation, the wedge-sled  402  is initially positioned at the distal end  350   a  of the track  350  with the blade  202  received within the receiving slit  309  of the stabilizing tongue  308  as the operator maneuvers the device to a desired location within the body. While the device is being maneuvered to the desired location, the anvil member  10  and the stapler member  17  are located adjacent to each other in the stapling position. When the desired position is reached, the operator pushes the push rod  152  distally to separate the anvil member  10  and the stapler member  17  into the tissue receiving position. Then the operator draws the portion of tissue to be is resectioned into the gap between the stapler member  17  and the anvil member  10  and draws the push rod  152  proximally to return the anvil member  10  and the stapler member  17  to the stapling position, gripping the tissue to be resected within the gap. The operator then pulls actuating cable  450  proximally, drawing the wedge-sled  402  towards the proximal end  350   b  of the track  350 . As the cam surface  412  on the wedge-sled passes beneath each one of the plurality of staple slits  34 , the cam surface  412  drives each one of a plurality of staple drivers  472  (each being disposed within a corresponding one of the staple slits  34 ) sequentially driving a plurality of staples out of the staple slits  34  to staple the tissue gripped between the anvil head  10   c  and the stapler head  17   c . In addition, the cutting blade  202  coupled to the blade handle  408  of the wedge-sled  402  is pulled through the blade slit  21  to resection the tissue which has now been stapled off from the organ. 
     When the tissue has been resectioned, the operator pushes the operating cable  450  distally to return the cutting blade  202  to the receiving slit  309  of the stabilizing wedge  308 . The device may then be withdrawn from the body. 
     As shown in FIGS. 23 and 25, the anvil member  10  and the stapler member  17  have a tissue receiving position shown in FIG. 25, and a stapling position shown in FIG.  23 . Therefore, it is necessary to allow the actuating cable  450  disposed within the tube  332  and received within the stapler head  17   c  to correspondingly move with the stapler member  17 . Accordingly, a channel  330  is provided in the connecting adapter  25  to receive the tube  332  therein. The channel  330  may preferably be formed within the connecting adapter  25  to substantially correspond to the arc path along which the tube  332  is pulled by the stapler member  17 , as the stapler member  17  moves between the tissue receiving and the stapling positions. Thus, the channel minimizes bending and crimping of the tube  332 . 
     Those skilled in the art will understand that although the proximal housing  12  in any of the embodiments may preferably be composed of a metallic-type material, the proximal housing  12  may also be composed of a clear plastic-type material which would allow the user to operate the working head assembly  2  under visual observation by partially withdrawing the endoscope  8  into the second endoscope lumen  52  in the proximal housing  12 . The user could then look through the walls of the endoscope lumen  52  into the proximal housing  12  to, for example, observe whether each of the plurality of staple drivers  472  have been actuated. In addition, the user may also observe whether the wedge  402  shown in FIGS. 10 a  and  10   b  is locked into the blade portion  420  as described above. Alternatively, selected portions of the proximal housing  12  may be composed of the clear plastic-type material providing a ‘window’ to view through the proximal housing  12 . 
     Those skilled in the art will also understand that although the above-described embodiments show mechanical force transmission between the control handle and the working head assembly, this device could alternatively include an electronic control for receiving input from an operator coupled to a series of motors in the working head assembly. Those skilled in the art will further understand that the relative positioning of the stapling mechanisms and the position adjusting mechanisms to each other may be reversed, placing the stapling mechanisms in a distal-most position in relation to the position adjusting mechanism. The above described embodiments are for purposes of illustration only and the various modifications of these embodiments which will be apparent are considered to be within the scope of the teachings of this invention which is to be limited only by the claims appended hereto.

Technology Classification (CPC): 0